Search results for: clinical quality and safety

Authors: Siyathorn Khunon, Thanawit Buafai

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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

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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

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Authors: Nor Fazlina Iryani Abdul Hamid, Mohamad Khatim Hasan

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Evolution of software quality measurement has been started since McCall introduced his quality model in year 1977. Starting from there, several software quality models and software quality measurement methods had emerged but none of them focused on telecommunication industry. In this paper, the implementation of software quality measurement system for telecommunication industry was compulsory to accommodate the rapid growth of telecommunication industry. The quality value of the telecommunication related software could be calculated using this system by entering the required parameters. The system would calculate the quality value of the measured system based on predefined quality metrics and aggregated by referring to the quality model. It would classify the quality level of the software based on Net Satisfaction Index (NSI). Thus, software quality measurement system was important to both developers and users in order to produce high quality software product for telecommunication industry.

Keywords: software quality, quality measurement, quality model, quality metric, net satisfaction index

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Authors: Hyun Chul Koag, Hyun-Sik Ahn

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In this paper, we propose a design approach for the safety mechanism of an actuator used in a commercial vehicle’s EPS system. As the number of electric/electronic system in a vehicle increases, the importance of the functional safety has been receiving much attention. EPS(Electric Power Steering) systems for commercial vehicles require large power than passenger vehicles, and hence, dual motor can be applied to get more torque. We show how to formulate the development process for the design of hardware and software of an EPS system using dual motors. A lot of safety mechanisms for the processor, sensors, and memory have been suggested, however, those for actuators have not been fully researched. It is shown by metric analyses that the target ASIL(Automotive Safety Integrated Level) is satisfied in the point of view of hardware of EPS controller.

Keywords: safety mechanism, functional safety, commercial vehicles, electric power steering

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Authors: Sheikh Omar Sillah

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Introduction: Monitoring is an important means of ensuring the smooth implementation and quality of clinical trials. For many years, traditional site monitoring approaches have been critical in detecting data errors but not optimal in identifying fabricated and implanted data as well as non-random data distributions that may significantly invalidate study results. The objective of this paper was to provide recommendations based on best statistical monitoring practices for detecting data-integrity issues suggestive of fabrication and implantation early in the study conduct to allow implementation of meaningful corrective and preventive actions. Methodology: Electronic bibliographic databases (Medline, Embase, PubMed, Scopus, and Web of Science) were used for the literature search, and both qualitative and quantitative studies were sought. Search results were uploaded into Eppi-Reviewer Software, and only publications written in the English language from 2012 were included in the review. Gray literature not considered to present reproducible methods was excluded. Results: A total of 18 peer-reviewed publications were included in the review. The publications demonstrated that traditional site monitoring techniques are not efficient in detecting data anomalies. By specifying project-specific parameters such as laboratory reference range values, visit schedules, etc., with appropriate interactive data monitoring, statistical monitoring can offer early signals of data anomalies to study teams. The review further revealed that statistical monitoring is useful to identify unusual data patterns that might be revealing issues that could impact data integrity or may potentially impact study participants' safety. However, subjective measures may not be good candidates for statistical monitoring. Conclusion: The statistical monitoring approach requires a combination of education, training, and experience sufficient to implement its principles in detecting data anomalies for the statistical aspects of a clinical trial.

Keywords: statistical monitoring, data anomalies, clinical trials, traditional monitoring

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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: A. Orlov, V. Rachkov

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The future of Nuclear Energetics is seen in fast reactors with inherent safety working in the closed nuclear fuel cycle. The concept of inherent safety, which lies in deterministic elimination of the most severe accidents due to inherent properties of the reactor rather than through building up engineered barriers, is a cornerstone of success in ensuring safety and economic efficiency of future Nuclear Energetics. The focus of this paper is one of the key elements of inherent safety - the lead coolant of a nuclear reactor. Advantages of lead coolant for reactor application, influence on safety are reviewed. BREST-OD-300 fast reactor, currently being developed in Russia withing the “Proryv” Project utilizes lead coolant and a special set of measures and devices, called technology of lead coolant that ensures safe operation in a wide range of temperatures. Here these technological elements are reviewed, and current progress in their development is discussed.

Keywords: BREST-OD-300. , fast reactor, inherent safety, lead coolant

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Authors: Kevin Wongleedee

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Food quality and risks are major concerns for inbound senior tourists when visiting tourist destinations in Thailand. The purposes of this study were to investigate food quality and risks perceived by inbound senior tourists. This paper drew upon data collection from an inbound senior tourist survey conducted in Thailand during summer 2013. Summer time in Thailand is a high season for inbound tourists. It is also a high risk period in which a variety food safety issues and incidents have often occurred. The survey was structured primarily to obtain inbound senior tourists’ concerns toward a variety of food quality and risks they encountered during their trip in Thailand. A total of 400 inbound senior tourists were elicited as data input for mean and standard deviation. The findings revealed that inbound tourists rated the overall food quality at a high level and the three most important perceived food risks were 1) unclean physical cooking facility, 2) toxic chemical handling, and 3) unclean water.

Keywords: food quality, inbound senior tourists, risks, Thailand

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Authors: Shadab Bahreini

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Public transportation is one of the most important aspects of cities, which impacts various factors of the Quality of Life (QoL) of citizens. A passenger's experience is influenced by a variety of indicators in addition to the cost and safety of the trip. This article intends to investigate how QoL is affected by public transport in an urban environment by introducing a literature review of QoL and Quality of Urban Life (QoUL), investigating the intersection of QoL and public transport, and reviewing the background theory for Transport Quality of Life (TQoL). The article proposes a Public Transport Quality of Life (PTQoL) framework comprised of a set of indicators that measure how public transport impacts QoL across personal (physical and mental), socioeconomic, and environmental dimensions. The study proposes using the framework to evaluate objective or subjective factors affecting a person's QoL regarding public transport. Finally, it concludes that public transport is a key component in shaping QoL in urban environments and that policymakers and urban planners should use the PTQoL framework to make evidence-based decisions to improve public transport systems and their impact on QoL.

Keywords: public transport, quality of life, subjective and objective indicators, urban environment

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Authors: Khaled M. Alhawiti

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This paper investigates the future of medicine and the use of Natural language processing. The importance of having correct clinical information available online is remarkable; improving patient care at affordable costs could be achieved using automated applications to use the online clinical information. The major challenge towards the retrieval of such vital information is to have it appropriately coded. Majority of the online patient reports are not found to be coded and not accessible as its recorded in natural language text. The use of Natural Language processing provides a feasible solution by retrieving and organizing clinical information, available in text and transforming clinical data that is available for use. Systems used in NLP are rather complex to construct, as they entail considerable knowledge, however significant development has been made. Newly formed NLP systems have been tested and have established performance that is promising and considered as practical clinical applications.

Keywords: clinical information, information retrieval, natural language processing, automated applications

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Authors: N. Borjalilu, P. Rabiei, A. Enjoo

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Flight Data Monitoring (FDM) program assists an operator in aviation industries to identify, quantify, assess and address operational safety risks, in order to improve safety of flight operations. FDM is a powerful tool for an aircraft operator integrated into the operator’s Safety Management System (SMS), allowing to detect, confirm, and assess safety issues and to check the effectiveness of corrective actions, associated with human errors. This article proposes a model for safety risk assessment level of flight data in a different aspect of event focus based on fuzzy set values. It permits to evaluate the operational safety level from the point of view of flight activities. The main advantages of this method are proposed qualitative safety analysis of flight data. This research applies the opinions of the aviation experts through a number of questionnaires Related to flight data in four categories of occurrence that can take place during an accident or an incident such as: Runway Excursions (RE), Controlled Flight Into Terrain (CFIT), Mid-Air Collision (MAC), Loss of Control in Flight (LOC-I). By weighting each one (by F-TOPSIS) and applying it to the number of risks of the event, the safety risk of each related events can be obtained.

Keywords: F-topsis, fuzzy set, flight data monitoring (FDM), flight safety

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Authors: Upal Barua

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Crash risk at intersections is a critical safety issue. This paper examines the effectiveness of removing an existing off-set at an intersection by realignment, in reducing crashes. Empirical Bayes method was applied to conduct a before-and-after study to assess the effect of this safety improvement. The Transportation Safety Improvement Program in Austin Transportation Department completed several safety improvement projects at high crash intersections with a view to reducing crashes. One of the common safety improvement techniques applied was the realignment of intersection approaches removing an existing off-set. This paper illustrates how this safety improvement technique is applied at a high crash intersection from inception to completion. This paper also highlights the significant crash reductions achieved from this safety improvement technique applying Empirical Bayes method in a before-and-after study. The result showed that realignment of intersection approaches removing an existing off-set can reduce crashes by 53%. This paper also features the state of the art techniques applied in planning, engineering, designing and construction of this safety improvement, key factors driving the success, and lessons learned in the process.

Keywords: crash risk, intersection, off-set, safety improvement technique, before-and-after study, empirical Bayes method

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Authors: Qingxin Chen, Liben Jiang, Andrew Smith, Karim Hadjri

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Since 2007, the Chinese food industry has undergone serious food contamination in the baby dairy industry, especially milk powder contamination. One of the milk powder products was found to contain melamine and a significant number (294,000) of babies were affected by kidney stones. Due to growing concerns among consumers about food safety and protection, and high pressure from central government, companies must take radical action to ensure food quality protection through the use of an appropriate quality management system. Previously, though researchers have investigated the health and safety aspects of food industries and products, quality issues concerning food products in China have been largely over-looked. Issues associated with baby dairy products and their quality issues have not been discussed in depth. This paper investigates the impact of quality management systems on the Chinese baby dairy product industry. A literature review was carried out to analyse the use of quality management systems within the Chinese milk power market. Moreover, quality concepts, relevant standards, laws, regulations and special issues (such as Melamine, Flavacin M1 contamination) have been analysed in detail. A qualitative research approach is employed, whereby preliminary analysis was conducted by interview, and data analysis based on interview responses from four selected Chinese baby dairy product companies was carried out. Through the analysis of literature review and data findings, it has been revealed that for quality management system that has been designed by many practitioners, many theories, models, conceptualisation, and systems are present. These standards and procedures should be followed in order to provide quality products to consumers, but the implementation is lacking in the Chinese baby dairy industry. Quality management systems have been applied by the selected companies but the implementation still needs improvement. For instance, the companies have to take measures to improve their processes and procedures with relevant standards. The government need to make more interventions and take a greater supervisory role in the production process. In general, this research presents implications for the regulatory bodies, Chinese Government and dairy food companies. There are food safety laws prevalent in China but they have not been widely practiced by companies. Regulatory bodies must take a greater role in ensuring compliance with laws and regulations. The Chinese government must also play a special role in urging companies to implement relevant quality control processes. The baby dairy companies not only have to accept the interventions from the regulatory bodies and government, they also need to ensure that production, storage, distribution and other processes will follow the relevant rules and standards.

Keywords: baby dairy product, food quality, milk powder contamination, quality management system

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Authors: Fateme Hadadian, Behnam Khaledi Paveh, Hosein Feizi

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Background: High number of patients with end-stage renal disease worldwide, and Iran and the patients required hemodialysis, As well as symptoms and treatment process and its impact on quality of life The researcher had to take a step towards solving these problems. Methods: In randomized clinical trial in 60 hemodialysis patients admitted to hospital hemodialysis Imam Reza (AS) were studied. Using questionnaires dialysis patients' QOL, quality of life was measured in patients and controls were divided randomly into two groups. Benson's relaxation method for the experimental group and two months at home, once per day, respectively and the control group received no special action. Immediately after the end of the period with was used for evaluating the quality of life in both the experimental and control groups were survey and data using independent t-test were used for statistical analysis. Results: The general dimensions of quality of life scores before and after intervention, there was significant difference (P=0/001). But this difference was not significant after QOL (P=0/2). Between QOL scores before and after treatment between the two groups was statistically significant (P=0/02). Conclusion: Benson relaxation has the desired effect on quality of life in hemodialysis patients and can be used as a useful method to enhance the quality of life in hemodialysis patients, implementation and training will be given.

Keywords: hemodialysis, quality of life, Benson muscle relaxation, biomedicine

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Authors: Heiko Jessen, Laura Tanus, Slobodan Ruzicic

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Objectives: The efficacy of Stribild®, an integrase strand transfer inhibitor (INSTI) -based STR, has been evaluated in randomized clinical trials and it has demonstrated durable capability in terms of achieving sustained suppression of HIV-1 RNA-levels. However, differences in monitoring frequency, existing selection bias and profile of patients enrolled in the trials, may all result in divergent efficacy of this regimen in routine clinical settings. The aim of this study was to assess the virologic outcomes, safety and tolerability profile of Stribild® in a routine clinical setting. Methods: This was a retrospective monocentric analysis on HIV-1-infected patients, who started with or were switched to Stribild®. Virological failure (VF) was defined as confirmed HIV-RNA>50 copies/ml. The minimum time of follow-up was 24 weeks. The percentage of patients remaining free of therapeutic failure was estimated using the time-to-loss-of-virologic-response (TLOVR) algorithm, by intent-to-treat analysis. Results: We analyzed the data of 197 patients (56 ART-naïve and 141 treatment-experienced patients), who fulfilled the inclusion criteria. Majority (95.9%) of patients were male. The median time of HIV-infection at baseline was 2 months in treatment-naïve and 70 months in treatment-experienced patients. Median time [IQR] under ART in treatment-experienced patients was 37 months. Among the treatment-experienced patients 27.0% had already been treated with a regimen consisting of two NRTIs and one INSTI, whereas 18.4% of them experienced a VF. The median time [IQR] of virological suppression prior to therapy with Stribild® in the treatment-experienced patients was 10 months [0-27]. At the end of follow-up (median 33 months), 87.3% (95% CI, 83.5-91.2) of treatment-naïve and 80.3% (95% CI, 75.8-84.8) of treatment-experienced patients remained free of therapeutic failure. Considering only treatment-experienced patients with baseline VL<50 copies/ml, 83.0% (95% CI, 78.5-87.5) remained free of therapeutic failure. A total of 17 patients stopped treatment with Stribild®, 5.4% (3/56) of them were treatment-naïve and 9.9% (14/141) were treatment-experienced patients. The Stribild® therapy was discontinued in 2 (1.0%) because of VF, loss to follow-up in 4 (2.0%), and drug-drug interactions in 2 (1.0%) patients. Adverse events were in 7 (3.6%) patients the reason to switch from therapy with Stribild® and further 2 (1.0%) patients decided personally to switch. The most frequently observed adverse events were gastrointestinal side effects (20.0%), headache (8%), rash events (7%) and dizziness (6%). In two patients we observed an emergence of novel resistances in integrase-gene. The N155H evolved in one patient and resulted in VF. In another patient S119R evolved either during or shortly upon switch from therapy with Stribild®. In one further patient with VF two novel mutations in the RT-gene were observed when compared to historical genotypic test result (V106I/M and M184V), whereby it is not clear whether they evolved during or already before the switch to Stribild®. Conclusions: Effectiveness of Stribild® for treatment-naïve patients was consistent with data obtained in clinical trials. The safety and tolerability profile as well as resistance development confirmed clinical efficacy of Stribild® in a daily practice setting.

Keywords: ART, HIV, integrase inhibitor, stribild

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Authors: Bárbara Durão, Pedro Almeida, David Ramilo, André Meneses, Rute Canejo-Teixeira

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The importance of quality of life (QoL) assessment in veterinary medicine is an integral part of patient care. This is especially true in cases of chronic diseases, such as chronic kidney disease (CKD), where the ever more advanced treatment options prolong the patient’s life. Whether this prolongment of life comes with an acceptable quality of life remains has been called into question. The aim of this study was to evaluate the relationship between CKD disease biomarkers and QoL in cats. Thirty-seven cats diagnosed with CKD and with no known concurrent illness were enrolled in an observational study. Through the course of several evaluations, renal biomarkers were assessed in blood and urine samples, and owners retrospectively described their cat’s quality of life using a validated instrument for this disease. Correlations between QoL scores (AWIS) and the biomarkers were assessed using Spearman’s rank test. Statistical significance was set at p-value < 0.05, and every serial sample was considered independent. Thirty-seven cats met the inclusion criteria, and all owners completed the questionnaire every time their pet was evaluated, giving a total of eighty-four questionnaires, and the average-weighted-impact-score was –0.5. Results showed there was a statistically significant correlation between the quality of life and most of 17 the studied biomarkers and confirmed that CKD has a negative impact on QoL in cats especially due to the management of the disease and secondary appetite disorders. To our knowledge, this is the attempt to assess the correlation between renal biomarkers and QoL in cats. Our results reveal a strong potential of this type of approach in clinical management, mainly in situations where it is not possible to measure biomarkers. Whilst health-related QoL is a reliable predictor of mortality and morbidity in humans; our findings can help improve the clinical practice in cats with CKD.

Keywords: chronic kidney disease, biomarkers, quality of life, feline

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Authors: Preeda Sansakorn, Min An

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In order to be capable of dealing with uncertainties, subjectivities, including vagueness arising in building construction projects, the application of fuzzy reasoning technique based on fuzzy set theory is proposed. This study contributes significantly to the development of a fuzzy reasoning safety risk assessment model for building construction projects that could be employed to assess the risk magnitude of each hazardous event identified during construction, and a third parameter of probability of consequence is incorporated in the model. By using the proposed safety risk analysis methodology, more reliable and less ambiguities, which provide the safety risk management project team for decision-making purposes.

Keywords: safety risk assessment, building construction safety, fuzzy reasoning, construction risk assessment model, building construction projects

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Authors: Basavaraj Kabade, K. T. Nagaraja, Swathi Ramanathan, A. Veeraragavan, P. S. Reashma

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Deteriorating quality of the pedestrian environment and the increasing risk of pedestrian crashes are major concerns for most of the cities in India. The recent shift in the priority to motorized transport and the abating condition of existing pedestrian facilities can be considered as prime reasons for the increasing pedestrian related crashes in India. Bengaluru City – the IT capital hub of the nation is not much different from this. The increase in number of pedestrian crashes in Bengaluru reflects the same. To resolve this issue and to ensure safe, sustainable and pedestrian friendly sidewalks, Govt. of Karnataka, India has implemented newfangled pedestrian sidewalks popularized programme named Tender S.U.R.E. (Specifications for Urban Road Execution) projects. Tender SURE adopts unique urban street design guidelines where the pedestrians are given prime preference. The present study presents an assessment of the quality and performance of the pedestrian side walk and the walkability index of the newly built pedestrian friendly sidewalks. Various physical and environmental factors affecting pedestrian safety are identified and studied in detail. The pedestrian mobility is quantified through Pedestrian Level of Service (PLoS) and the pedestrian walking comfort is measured by calculating the Walkability Index (WI). It is observed that the new initiatives taken in reference to improving pedestrian safety have succeeded in Bengaluru by attaining a level of Service of ‘A’ and with a good WI score.

Keywords: pedestrian safety, pedestrian level of service (PLoS), Right of Way (RoW), Tender S.U.R.E (Specifications for Urban Road Execution), walkability index (WI), walkway facilities

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Authors: Axel Mancebo, Ana M. Bada, Angel Casacó, Bárbara González, Avelina León, María E. Arteaga, Consuelo González, Belinda Sánchez, Adriana Carr, Nuris Ledón, Arianna Iglesias

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Despite the many preventive and therapeutic modalities aimed at curing cancer, it remains as a serious world health problem. Promising recent developments suggest that cancer immunotherapy may be the next great hope for cancer treatment. EGFRs are receptor tyrosine kinases and it is considered an important therapeutic target related with tumor progression, and several types of molecular therapies, including monoclonal antibodies, small molecules, and vaccines, have been developed to target the HER family of receptors. On the other hand, gangliosides are membrane glycosphingolipids that contain two variants of sialic acid, the N-acetylated (NeuAc) and the N-glycolylated (NeuGc) variant. The high expression of this antigen-specific molecule has been associated with malignant tumor progression and immunosuppressive mechanisms, so ganglioside could be considered as the target for cancer immunotherapy. We have been working for several years in the safety evaluation of cancer vaccines targeting these two systems, the EGF receptor and ganglioside. We presented in this work results of repeated dose toxicity studies performed in Sprague Dawley rats and Cynomolgus monkeys, including clinical observations, body weight and rectal temperature measuring, clinical pathology analysis, gross necropsy and histological examination in rodent studies, and immunological evaluation. Immunizations were capable of inducing mainly inflammatory effects at the injection site, with findings largely attributable to the adjuvants used and probably enhanced by the immunological properties of the antigens. In general, these vaccines were shown to be well tolerated, and these studies in relevant species allow treating cancer patients with tumors during long periods with relative weight safety margin.

Keywords: cancer vaccines, safety, toxicology, rats, non human primates

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Authors: Ana Claudia de Souza Costa, Beatriz de Cássia Pinheiro Goulart, Karine de Cássia Cavalari, Henrique Ceretta Oliveira, Edineis de Brito Guirardello

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Background: During the COVID-19 pandemic, nursing represents the largest category of health professionals who were on the front line. Thus, investigating the practice environment and the job satisfaction of nursing professionals during the pandemic becomes fundamental since it reflects on the quality of care and the safety climate. The aim of this study was to evaluate and compare the nursing professionals' perception of the work environment, job satisfaction, and safety climate of the different hospitals and work shifts during the COVID-19 pandemic. Method: This is a cross-sectional survey with 130 nursing professionals from public, private and mixed hospitals in Brazil. For data collection, was used an electronic form containing the personal and occupational variables, work environment, job satisfaction, and safety climate. The data were analyzed using descriptive statistics and ANOVA or Kruskal-Wallis tests according to the data distribution. The distribution was evaluated by means of the Shapiro-Wilk test. The analysis was done in the SPSS 23 software, and it was considered a significance level of 5%. Results: The mean age of the participants was 35 years (±9.8), with a mean time of 6.4 years (±6.7) of working experience in the institution. Overall, the nursing professionals evaluated the work environment as favorable; they were dissatisfied with their job in terms of pay, promotion, benefits, contingent rewards, operating procedures and satisfied with coworkers, nature of work, supervision, and communication, and had a negative perception of the safety climate. When comparing the hospitals, it was found that they did not differ in their perception of the work environment and safety climate. However, they differed with regard to job satisfaction, demonstrating that nursing professionals from public hospitals were more dissatisfied with their work with regard to promotion when compared to professionals from private (p=0.02) and mixed hospitals (p< 0.01) and nursing professionals from mixed hospitals were more satisfied than those from private hospitals (p= 0.04) with regard to supervision. Participants working in night shifts had the worst perception of the work environment related to nurse participation in hospital affairs (p= 0.02), nursing foundations for quality care (p= 0.01), nurse manager ability, leadership and support (p= 0.02), safety climate (p< 0.01), job satisfaction related to contingent rewards (p= 0.04), nature of work (p= 0.03) and supervision (p< 0.01). Conclusion: The nursing professionals had a favorable perception of the environment and safety climate but differed among hospitals regarding job satisfaction for the promotion and supervision domains. There was also a difference between the participants regarding the work shifts, being the night shifts, those with the lowest scores, except for satisfaction with operational conditions.

Keywords: health facility environment, job satisfaction, patient safety, nursing

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Authors: Umamaheswari Shanmugam, Silvia Ronchi, Radu Vornicu

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Software, artificial intelligence, and machine learning can improve healthcare through innovative and advanced technologies that are able to use the large amount and variety of data generated during healthcare services every day. As we read the news, over 500 machine learning or other artificial intelligence medical devices have now received FDA clearance or approval, the first ones even preceding the year 2000. One of the big advantages of these new technologies is the ability to get experience and knowledge from real-world use and to continuously improve their performance. Healthcare systems and institutions can have a great benefit because the use of advanced technologies improves the same time 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 also to protect patients’ safety. The evolution and the continuous improvement of software used in healthcare must take into consideration 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 approval, but they are necessary to ensure performance, quality, and safety, and at the same time, they can be a business opportunity if the manufacturer is able to define in advance the appropriate regulatory strategy. 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: Narottam Puri, Bishnu Panigrahi, Narayan Pendse

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Background: Clinical Outcomes are the globally agreed upon, evidence-based measurable changes in health or quality of life resulting from the patient care. Reporting of outcomes and its continuous monitoring provides an opportunity for both assessing and improving the quality of patient care. In 2012, International Consortium Of HealthCare Outcome Measurement (ICHOM) was founded which has defined global Standard Sets for measuring the outcome of various treatments. Method: Monitoring of Clinical Outcomes was identified as a pillar of Fortis’ core value of Patient Centricity. The project was started as an in-house developed Clinical Outcomes Reporting Portal by the Fortis Medical IT team. Standard sets of Outcome measurement developed by ICHOM were used. A pilot was run at Fortis Escorts Heart Institute from Aug’13 – Dec’13.Starting Jan’14, it was implemented across 11 hospitals of the group. The scope was hospital-wide and major clinical specialties: Cardiac Sciences, Orthopedics & Joint Replacement were covered. The internally developed portal had its limitations of report generation and also capturing of Patient related outcomes was restricted. A year later, the company provisioned for an ICHOM Certified Software product which could provide a platform for data capturing and reporting to ensure compliance with all ICHOM requirements. Post a year of the launch of the software; Fortis Healthcare has become the 1st Healthcare Provider in Asia to publish Clinical Outcomes data for the Coronary Artery Disease Standard Set comprising of Coronary Artery Bypass Graft and Percutaneous Coronary Interventions) in the public domain. (Jan 2016). Results: This project has helped in firmly establishing a culture of monitoring and reporting Clinical Outcomes across Fortis Hospitals. Given the diverse nature of the healthcare delivery model at Fortis Network, which comprises of hospitals of varying size and specialty-mix and practically covering the entire span of the country, standardization of data collection and reporting methodology is a huge achievement in itself. 95% case reporting was achieved with more than 90% data completion at the end of Phase 1 (March 2016). Post implementation the group now has one year of data from its own hospitals. This has helped identify the gaps and plan towards ways to bridge them and also establish internal benchmarks for continual improvement. Besides the value created for the group includes: 1. Entire Fortis community has been sensitized on the importance of Clinical Outcomes monitoring for patient centric care. Initial skepticism and cynicism has been countered by effective stakeholder engagement and automation of processes. 2. Measuring quality is the first step in improving quality. Data analysis has helped compare clinical results with best-in-class hospitals and identify improvement opportunities. 3. Clinical fraternity is extremely pleased to be part of this initiative and has taken ownership of the project. Conclusion: Fortis Healthcare is the pioneer in the monitoring of Clinical Outcomes. Implementation of ICHOM standards has helped Fortis Clinical Excellence Program in improving patient engagement and strengthening its commitment to its core value of Patient Centricity. Validation and certification of the Clinical Outcomes data by an ICHOM Certified Supplier adds confidence to its claim of being leaders in this space.

Keywords: clinical outcomes, healthcare delivery, patient centricity, ICHOM

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Authors: Hamidullah Binol, Abdullah Bal

Abstract:

Nowadays, food safety is a great public concern; therefore, robust and effective techniques are required for detecting the safety situation of goods. Hyperspectral Imaging (HSI) is an attractive material for researchers to inspect food quality and safety estimation such as meat quality assessment, automated poultry carcass inspection, quality evaluation of fish, bruise detection of apples, quality analysis and grading of citrus fruits, bruise detection of strawberry, visualization of sugar distribution of melons, measuring ripening of tomatoes, defect detection of pickling cucumber, and classification of wheat kernels. HSI can be used to concurrently collect large amounts of spatial and spectral data on the objects being observed. This technique yields with exceptional detection skills, which otherwise cannot be achieved with either imaging or spectroscopy alone. This paper presents a nonlinear technique based on kernel Fukunaga-Koontz transform (KFKT) for detection of fat content in ground meat using HSI. The KFKT which is the nonlinear version of FKT is one of the most effective techniques for solving problems involving two-pattern nature. The conventional FKT method has been improved with kernel machines for increasing the nonlinear discrimination ability and capturing higher order of statistics of data. The proposed approach in this paper aims to segment the fat content of the ground meat by regarding the fat as target class which is tried to be separated from the remaining classes (as clutter). We have applied the KFKT on visible and nearinfrared (VNIR) hyperspectral images of ground meat to determine fat percentage. The experimental studies indicate that the proposed technique produces high detection performance for fat ratio in ground meat.

Keywords: food (ground meat) inspection, Fukunaga-Koontz transform, hyperspectral imaging, kernel methods

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Authors: A. Alrasheed, I. Connerton

Abstract:

Providing patients with safe meals on a daily basis is one of the challenges in the healthcare sector. In Saudi Arabia matters related to food safety and hygiene have been the heart of the Ministry of Health (MOH) and Saudi Food and Drugs Authority (SFDA). The aim of this study is to examine the causes of inadequate implementation of food safety management systems such as HACCP in Riyadh’s MOH hospitals. By the law, food safety must be managed using a documented, HACCP based approach, and food handlers must be appropriately trained in food safety. Food handlers in Saudi Arabia are not required to provide a certificate or attend a food handling training course even in healthcare sectors. Since food safety and hygiene issues are of increasing importance for Saudi Arabian health decision makers, the SFDA has been established to apply food hygiene requirements in all food operations. It should be pointed out that the implications of food outbreaks on the whole society may potentially go beyond individual health impacts but also impact on the Nation’s health and bring about economic repercussions.

Keywords: food safety, patient, hospital, HACCP

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Authors: Beng Zhen Yeow

Abstract:

In most work that involves children, the voice of the children is often not heard. This is ironic since a lot of discussions might involve their welfare and safety. It might seem natural that the professionals should hear from them about what they wish for instead of deciding what is best for them. However, this, unfortunately, might be more the exception than the norm in most case and hence in many instances, children are merely 'subjects' in conversations about safety instead of active participants in the construction or creation of safety in the family. There might be many reasons why it does not happen in our work. Firstly, professionals have learnt how to 'socialise' into their professional roles and hence in the process become 'un-childlike'. Secondly, there is also a lack of professional training with regards to how to talk with children. Finally, there might be also a lack of concrete tools and techniques that are developed to facilitate the process. In this paper, the case study method is used to show how the idea of safety could be concretised and discussed with children and their family members, and hence making them active participants and co-creators of their own safety. Specific skills and techniques are highlighted through the case study. In this case, there was improvement in outcomes like no repeated offence or abuse. In addition, children were also able to advocate for their own safety after six months of intervention and how the family members were able to explicitly say what they can do to improve safety. The professionals in the safety network reported significant improvements. On top of that, the abused child who was removed due to child protection concerns, had verbalized observations of change in mother’s parenting abilities, and has requested for home leave to begin due to ownership of safety planning and having confidence to co-create safety for her siblings and herself together with the professionals in the safety network. Children becoming active participants in the co-creation of safety not only serve the purpose in allowing them to own a 'voice' but at the same time, give them greater confidence to protect themselves at home and in other contexts outside of home.

Keywords: partnering for safety, collaborative social work, family and systemic psychotherapy, child protection

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Authors: Erol Karaca

Abstract:

This study aims to analyze ceramic employees’ occupational health and safety training expectations. To that general objective, the study tries to examine whether occupational health and safety training expectations of ceramic employees meaningfully differentiate depending on demographic features and professional, social and economic conditions. For this purpose, the research data was collected through “Questionnaire of Occupational Health and Safety Training Expectation” (QSOHSTE) consisting of 25 open and close-ended questions developed by the researcher on the base of the literature review. QSOHSTE was applied to 125 ceramic employees working in Kutahya, Turkey. Data obtained from questionnaires were analyzed via SPSS 21. The findings, obtained from the study, revealed that employees’ agreement level to occupational health and safety training expectation statements is generally high-level. These findings also reveals that employees have various expectations about occupational health and safety training. These expectations are increasing sensitivity towards occupational health and safety training about the prevention of occupational accidents and diseases, contributing occupational health and safety training in establishing healthy and safe working environment, requiring occupational health and safety training before starting work, in case of changing working equipment and new technological applications, necessity of measurement and evaluation after occupational health and safety training. Besides these findings, employees’ agreement level to occupational health and safety training expectation statements also varies in terms of educational level, professional seniority, income level and perception of economic condition.

Keywords: occupational health and safety, occupational training, occupational expectation, professional seniority

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Authors: Pieter A. Cornelissen, Joris J. Van Hoof

Abstract:

The interest in improving occupational safety started almost simultaneously with the beginning of the Industrial Revolution. Yet, it was not until the late 1970’s before the role of communication was considered in scientific research regarding occupational safety. In recent years the importance of communication as a means to improve occupational safety has increased. Not only as communication might have a direct effect on safety performance and safety outcomes, but also as it can be viewed as a major component of other important safety-related elements (e.g., training, safety meetings, leadership). And while safety communication is an increasingly important topic in research, its operationalization is often vague and differs among studies. This is not only problematic when comparing results, but also in applying these results to practice and the work floor. By means of an in-depth analysis—building on an existing dataset—this review aims to overcome these problems. The initial database search yielded 25.527 articles, which was reduced to a research corpus of 176 articles. Focusing on the 37 articles of this corpus that addressed communication (related to safety outcomes and safety performance), the current study will provide a comprehensive overview of the role and effects of safety communication and outlines the conditions under which communication contributes to a safer work environment. The study shows that in literature a distinction is commonly made between safety communication (i.e., the exchange or dissemination of safety-related information) and feedback (i.e. a reactive form of communication). And although there is a consensus among researchers that both communication and feedback positively affect safety performance, there is a debate about the directness of this relationship. Whereas some researchers assume a direct relationship between safety communication and safety performance, others state that this relationship is mediated by safety climate. One of the key findings is that despite the strongly present view that safety communication is a formal and top-down safety management tool, researchers stress the importance of open communication that encourages and allows employees to express their worries, experiences, views, and share information. This raises questions with regard to other directions (e.g., bottom-up, horizontal) and forms of communication (e.g., informal). The current review proposes a framework to overcome the often vague and different operationalizations of safety communication. The proposed framework can be used to characterize safety communication in terms of stakeholders, direction, and characteristics of communication (e.g., medium usage).

Keywords: communication, feedback, occupational safety, review

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Authors: Aodai Abdul-Illah Ismail

Abstract:

Even though the dramatic progress that has been made in traffic safety, but still millions of peoples get killed or injured as a result of traffic crashes, besides the huge amount of economic losses due to these crashes. So traffic safety continues to be one of the most important serious issues worldwide, and it affects everyone who uses the road network system, whether you drive, walk, cycle, or push a pram. One of the most important sides that offers promise for further progress in relation to traffic safety is related to risky groups (special population groups) who may have higher potential to be involved in accidents. Traffic safety needs of risky groups are different from each other and also from the average population. Due to the various limitations between these special groups from each other and from the average population, it is not possible to address all the issues –at the same time- raising the importance ranking among the other safety issues. This paper explains a procedure used to identify the most critical traffic safety issues of five risky groups, which include younger, older and female drivers, people with disabilities and school aged children. Multi criteria used in selecting the critical issues because the single criteria is not sufficient. Highway safety professionals were surveyed to obtain the ranking of importance among the risky groups and then to develop the final ranking among issues by applying weight for each of the criteria.

Keywords: traffic safety, risky groups, old drivers, young drivers

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Authors: Alyaa Farouk Abdelfattah Ibrahim, Samah Mohamed, Huda Jrady, Mashail Alrashidi, Alaa Mohammad, Fatimah Alotaibi, Maram Almutiri

Abstract:

Participation in volunteering was associated with better mental and physical health, self-esteem, and life satisfaction. The main motivator for students in particular is the chance to gain work-related experiences, improve skills, and build on qualifications that may help them achieve their educational goals and further their careers. This study aimed to assess the effect of summer training volunteering practices in healthcare on self-confidence of nursing students in Riyadh. In a crossectional study design, 150 nursing students at King Saud bin Abdul-Aziz University for health sciences in Riyadh were included in the study. Bio-socio-demographic, self-confidence, patients’ care and skills questionnaires were used for data collection. Results: Participants’ age ranged between 20 and 26 years. The majority were from the educational level seven (80%). 40.7 % of them reported volunteering in summer training programs; 70.37% of them volunteered at least once and for a duration of at least one month. Nursing students from level 6 were less likely to have self-confidence in their patients’ care skills than those in level 7. Students who volunteered were more likely to be more interested in becoming social, professional, and independent healthcare workers. There was no difference regarding experience in clinical skills and education by volunteering status. Clinical skills improved by a level of education in this group. Conclusion: Professional self-confidence and clinical performance are related in this group of nursing students. Monitoring, arranging, and encouraging volunteering activities for nursing students are important to help them broaden their interests, their self-confidence in their capabilities, and advancement in their chosen profession. Mostly, volunteering enhanced knowledge in patient safety and quality of care and attempts to secure volunteering opportunities should be a priority on the nursing education agenda.

Keywords: volunteering, health care volunteering, nursing students, summer training

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Authors: Ladda Her, Juntip Kanjanasilp, Ratree Sawangjit, Nathorn Chaiyakunapruk

Abstract:

Cough is the common symptom of the respiratory tract infections or non-infections; the duration of cough indicates a classification and severity of disease. Herbal medicines can be used as the alternative to drugs for relief of cough symptoms from acute and chronic disease. Eucalyptus was used for reducing cough with evidences suggesting it has an active role in reduction of airway inflammation. The present study aims to evaluate efficacy and safety of eucalyptus for relief of cough symptom in respiratory disease. Method: The Cochrane Library, MEDLINE (PubMed), Scopus, CINAHL, Springer, Science direct, ProQuest, and THAILIS databases. From its inception until 01/02/2019 for randomized control trials. We follow for the efficacy and safety of eucalyptus for reducing cough. Methodological quality was evaluated by using the Cochrane risk of bias tool; two reviewers in our team screened eligibility and extracted data. Result: Six studies were included for the review and five studies were included in the meta-analysis, there were 1.911 persons including children (n: 1) and adult (n: 5) studies; for study in children and adult were between 1 and 80 years old, respectively. Eucalyptus was used as mono herb (n: 2) and in combination with other herbs form (n: 4). All of the studies with eucalyptus were compared for efficacy and safety with placebo or standard treatment, Eucalyptus dosage form in studies included capsules, spray, and syrup. Heterogeneity was 32.44 used random effect model (I² = 1.2%, χ² = 1.01; P-value = 0.314). The efficacy of eucalyptus was showed a reduced cough symptom statistically significant (n = 402, RR: 1.40, 95%CI [1.19, 1.65], P-value < 0.0001) when compared with placebo. Adverse events (AEs) were reported mild to moderate intensity with mostly gastrointestinal symptom. The methodological quality of the included trials was overall poor. Conclusion: Eucalyptus appears to be beneficial and safe for relieving in respiratory diseases focus on cough frequency. The evidence was inconclusive due to limited quality trial. Well-designed trials for evaluating the effectiveness in humans, the effectiveness for reducing cough symptom in human is needed. Eucalyptus had safety as monotherapy or in combination with other herbs.

Keywords: cough, eucalyptus, cineole, herbal medicine, systematic review, meta-analysis

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