Search results for: clinical quality

Authors: Natalia C. E. S. Nascimento, Mercia L. Oliveira, Fernando R. A. Lima, Leonardo T. C. do Nascimento, Marina B. Silveira, Brigida G. A. Schirmer, Andrea V. Ferreira, Carlos Malamut, Juliana B. da Silva

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Tissue hypoxia is a common characteristic of solid tumors leading to decreased sensitivity to radiotherapy and chemotherapy. In the clinical context, tumor hypoxia assessment employing the positron emission tomography (PET) tracer ¹⁸F-fluoromisonidazole ([¹⁸F]FMISO) is helpful for physicians for planning and therapy adjusting. The aim of this work was to implement the synthesis of 18F-FMISO in a TRACERlab® MXFDG module and also to establish the quality control procedure. [¹⁸F]FMISO was synthesized at Centro de Desenvolvimento da Tecnologia Nuclear (CDTN/CNEN/Brazil) using an automated synthesizer (TRACERlab® MXFDG, GE) adapted for the production of [¹⁸F]FMISO. The FMISO chemical standard was purchased from ABX. 18O- enriched water was acquired from Center of Molecular Research. Reagent kits containing eluent solution, acetonitrile, ethanol, 2.0 M HCl solution, buffer solution, water for injections and [¹⁸F]FMISO precursor (dissolved in 2 ml acetonitrile) were purchased from ABX. The [¹⁸F]FMISO samples were purified by Solid Phase Extraction method. The quality requirements of [¹⁸F]FMISO are established in the European Pharmacopeia. According to that reference, quality control of [¹⁸F]FMISO should include appearance, pH, radionuclidic identity and purity, radiochemical identity and purity, chemical purity, residual solvents, bacterial endotoxins, and sterility. The duration of the synthesis process was 53 min, with radiochemical yield of (37.00 ± 0.01) % and the specific activity was more than 70 GBq/µmol. The syntheses were reproducible and showed satisfactory results. In relation to the quality control analysis, the samples were clear and colorless at pH 6.0. The spectrum emission, measured by using a High-Purity Germanium Detector (HPGe), presented a single peak at 511 keV and the half-life, determined by the decay method in an activimeter, was (111.0 ± 0.5) min, indicating no presence of radioactive contaminants, besides the desirable radionuclide (¹⁸F). The samples showed concentration of tetrabutylammonium (TBA) < 50μg/mL, assessed by visual comparison to TBA standard applied in the same thin layer chromatographic plate. Radiochemical purity was determined by high performance liquid chromatography (HPLC) and the results were 100%. Regarding the residual solvents tested, ethanol and acetonitrile presented concentration lower than 10% and 0.04%, respectively. Healthy female mice were injected via lateral tail vein with [¹⁸F]FMISO, microPET imaging studies (15 min) were performed after 2 h post injection (p.i), and the biodistribution was analyzed in five-time points (30, 60, 90, 120 and 180 min) after injection. Subsequently, organs/tissues were assayed for radioactivity with a gamma counter. All parameters of quality control test were in agreement to quality criteria confirming that [¹⁸F]FMISO was suitable for use in non-clinical and clinical trials, following the legal requirements for the production of new radiopharmaceuticals in Brazil.

Keywords: automatic radiosynthesis, hypoxic tumors, pharmacopeia, positron emitters, quality requirements

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Authors: Ghadeer Mohammad Said El-Sheikh, Samer Mohamad Shalhoob

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Medical equipment operation state is a valid reflection of health care organizations' performance, where such equipment highly contributes to the quality of healthcare services on several levels in which quality improvement has become an intrinsic part of the discourse and activities of health care services. In healthcare organizations, clinical and biomedical engineering departments play an essential role in maintaining the safety and efficiency of such equipment. One of the most challenging topics when it comes to such sophisticated equipment is the lifespan of medical equipment, where many factors will impact such characteristics of medical equipment through its life cycle. So far, many attempts have been made in order to address this issue where most of the approaches are kind of arbitrary approaches and one of the criticisms of existing approaches trying to estimate and understand the lifetime of a medical equipment lies under the inquiry of what are the environmental factors that can play into such a critical characteristic of a medical equipment. In an attempt to address this shortcoming, the purpose of our study rises where in addition to the standard technical factors taken into consideration through the decision-making process by a clinical engineer in case of medical equipment failure, the dimension of environmental factors shall be added. The investigations, researches and studies applied for the purpose of supporting the decision making process by a clinical engineers and assessing the lifespan of healthcare equipment’s in the Lebanese society was highly dependent on the identification of technical criteria’s that impacts the lifespan of a medical equipment where the affecting environmental factors didn’t receive the proper attention. The objective of our study is based on the need for introducing a new well-designed plan for evaluating medical equipment depending on two dimensions. According to this approach, the equipment that should be replaced or repaired will be classified based on a systematic method taking into account two essential criteria; the standard identified technical criteria and the added environmental criteria.

Keywords: technical, environmental, healthcare, characteristic of medical equipment

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Authors: Benjamin Kuester, Bjoern Eilert, Malte Stonis, Ludger Overmeyer

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Increasing quality requirements make reliable and effective quality management indispensable. This includes the complaint handling in which the 8D method is widely used. The 8D report as a written documentation of the 8D method is one of the key quality documents as it internally secures the quality standards and acts as a communication medium to the customer. In practice, however, the 8D report is mostly faulty and of poor quality. There is no quality control of 8D reports today. This paper describes the use of natural language processing for the automated evaluation of 8D reports. Based on semantic analysis and text-mining algorithms the presented system is able to uncover content and formal quality deficiencies and thus increases the quality of the complaint processing in the long term.

Keywords: 8D report, complaint management, evaluation system, text-mining

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Authors: Rubijesmin Abdul Latif

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This paper focuses on evaluating what are quality components of university websites in Malaysia especially the private universities. It is believed that with websites that prioritize quality, the websites will serve its intended users satisfactory. From the compiled analysis of other studies, quality components were identified and tested among 30 randomly selected respondents. Four Malaysia private university websites were compared and the highlights were better understanding of what users want for a quality university website.

Keywords: website evaluation, criteria, quality, usability, user experience, university website

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Authors: Nicholas P. Fenlon, Aisling Lavelle, David Mclean, Margaret O'riordan

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Background: The case for continuing professional development has been well made, and was formalized in Ireland in recent years through the enactment of the Medical Practitioner’s Act, which requires registered medical practitioners to complete a minimum of 50 hours CPD each year. The ICGP, who have been providing CPD opportunities to its members for many years, have responded to this need by developing a series of evidence-based, high-quality, multimedia modules across a range of clinical and non-clinical areas. (More traditional education opportunities are still being provided by the college also). Overview of Programme: The first module was released in September 2011, since when the eLearning program has grown steadily, and there are currently almost 20 modules available, with a further 5 in production. Each module contains three to six 10-minute video lessons, which use a combination of graphics, images, text, voice-over and clinical clips. These are supported by supplementary videos of expert pieces-to-camera, Q&As with content experts, clinical scenarios, external links and relevant documentation and other resources. Successful completion of MCQs will result in a Certificate of Completion, which can be printed or stored in Professional Competence portfolio. The Medical Practitioner’s Act requires doctors to gather CPD credits across 8 domains of practice, and various eLearning modules have been developed to address each. For instance, modules with a strong clinical content would include Management of Hypertension, Management of COPD, and Management of Asthma. Other modules focus on health promotion such as Promoting Smoking Cessation, Promoting Physical Activity, and Addressing Childhood Obesity. Modules where communication skills are keys include modules on Suicide Prevention and Management of Depression. Other modules, currently in development include non-clinical topics around risk management, including Confidentiality, Consent etc. Each module is developed by a core group, which includes where possible, a GP with a special interest in the area, and a content expert(s). The college works closely with a medical education consultant and a production company in developing and producing the modules. Modules can be accessed (with password) through the ICGP website and are available free to all ICGP members. Summary of Evaluation: There are over 1700 registered users to date (over 55% of College membership). The program was evaluated using an online survey in 2013 (N = 144/950 – 12%) and results were very positive overall but provided material for the further improvement of the program also. Future Plans: While knowledge can be imparted well through eLearning, skills and attitudes are more difficult to influence through an online environment. The college is now developing a series of linked workshops, which will lead to ICGP Professional Competence Awards. The first pilot workshop is scheduled for February 2015 and is Cardiology-themed. Participants will be required to complete the following 4 modules in advance of attending – Management of Hypertension, Management of Heart Failure, Promoting Smoking Cessation, and Promoting Physical Activity. The workshop will be case-based and interactive, addressing ECG Interpretation in General Practice. Conclusions: The ICGP have responded to members needs for high-quality evidence-based education delivered in a way that suits GPs.

Keywords: CPD opportunities, evidence-based, high quality, multimedia modules across a range of clinical and non-clinical areas, medical practitioner’s act

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Authors: Ilana Margalith, Yaron Niv

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One of the most important factors of professional health treatment is teamwork, in which each discipline contributes its expert knowledge, thus ensuring quality and a high standard of care as well as efficient communication (one of the International Patient Safety Goals). However, in most countries, students are educated separately by each health discipline. They are exposed to teamwork only during their clinical experience, which in some cases is short and skill-oriented. In addition, health organizations in most countries are hierarchical and although changes have occurred in the hierarchy of the medical system, there are still disciplines that underrate the unique contributions of other health professionals, thus, young graduates of health professions develop and base their perception of their peers from other disciplines on insufficient knowledge. In order to establish a wide-ranging perception among nursing students as to the contribution of different health professionals to the health of their patients, students at the Clalit Nursing Academy, Rabin Campus (Dina), Israel, participated in an interdisciplinary clinical discussion with students from several different professions, other than nursing, who were completing their clinical experience at Rabin Medical Center in medicine, health psychology, social work, audiology, physiotherapy and occupational therapy. The discussion was led by a medical-surgical nursing instructor. Their tutors received in advance, a case report enabling them to prepare the students as to how to present their professional theories and interventions regarding the case. Mutual stimulation and acknowledgment of the unique contribution of each part of the team enriched the nursing students' understanding as to how their own nursing interventions could be integrated into the entire process towards a safe and speedy recovery of the patient.

Keywords: health professions' students, interdisciplinary clinical discussion, nursing education, patient safety

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Authors: Gurmeet Kaur

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Agile software development methods are being recognized as popular, and efficient approach to the development of software system that has a short delivery period with high quality also that meets customer requirements with zero defect. In agile software development, quality means quality of code where in the quality is maintained through the use of methods or approaches like refactoring, test driven development, behavior driven development, acceptance test driven development, and demand driven development. Software quality is measured in term of metrics such as the number of defects during development of software. Usage of above mentioned methods or approaches, reduces the possibilities of defects in developed software, and hence improve quality. This paper focuses on study of agile based quality methods or approaches for software development that ensures improved quality of software as well as reduced cost, and customer satisfaction.

Keywords: ATDD, BDD, DDD, TDD

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Authors: David Pettitt, Benjamin Davies, Georg Holländer, David Brindley

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Cellular based therapies, whose origins can be traced from the intertwined concepts of tissue engineering and regenerative medicine, have the potential to transform the current medical landscape and offer an approach to managing what were once considered untreatable diseases. However, despite a large increase in basic science activity in the cell therapy arena alongside a growing portfolio of cell therapy trials, the number of industry products available for widespread clinical use correlates poorly with such a magnitude of activity, with the number of cell-based therapeutics in mainstream use remaining comparatively low. This research serves to quantitatively assess the barriers to the clinical adoption of cell-based therapeutics through identification of unique barriers, specific challenges and opportunities facing the development and adoption of such therapies.

Keywords: cell therapy, clinical adoption, commercialization, translation

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Authors: Samad Lotfollahzadeh

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Escherichia coli (E.coli) is the most isolated bacteria from blood circulation of septicemic calves. Given the prevalence of septicemia in animals and its economic importance in veterinary practice, better understanding of changes in clinical signs following disease, may contribute to early detection of the disorder. The present study has been carried out to detect changes of clinical signs in induced sepsis in calves with E.coli. Colisepticemia has been induced in 10 twenty-day old healthy Holstein- Frisian calves with intravenous injection of 1.5 X 109 colony forming units (cfu) of O111: H8 strain of E.coli. Clinical signs including rectal temperature, heart rate, respiratory rate, shock, appetite, sucking reflex, feces consistency, general behavior, dehydration and standing ability were recorded in experimental calves during 24 hours after induction of colisepticemia. Blood culture was also carried out from calves four times during the experiment. ANOVA with repeated measure is used to see changes of calves’ clinical signs to experimental colisepticemia, and values of P≤ 0.05 was considered statistically significant. Mean values of rectal temperature and heart rate as well as median values of respiratory rate, appetite, suckling reflex, standing ability and feces consistency of experimental calves increased significantly during the study (P<0.05). In the present study, median value of shock score was not significantly increased in experimental calves (P> 0.05). The results of present study showed that total score of clinical signs in calves with experimental colisepticemia increased significantly, although the score of some clinical signs such as shock did not change significantly.

Keywords: calves, clinical signs scoring, E. coli O111:H8, experimental colisepticemia

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Authors: Hui-Yi Wang, Shu-Mei Chen, Mei-Fang Liu

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Background and purpose: Providing clinical experience in medical education is an important discipline method where students can gradually apply their academic knowledge to clinical situations. The purpose of this study was to establish self-assessment questionnaires for students to assess their learning outcomes for two fields of physical therapy, orthopedic physical therapy, and pediatric physical therapy, in a clinical fieldwork course. Methods: The questionnaires were developed based on the core competence dimensions of the course. The content validity of the questionnaires was evaluated and established by expert meetings. Among the third-year undergraduate students who took the clinical fieldwork course, there were 49 students participated in this study. Teachers arranged for the students to study two professional fields, and each professional field conducted a three-week clinical lesson. The students filled out the self-assessment questionnaires before and after each three-week lesson. Results: The self-assessment questionnaires were established by expert meetings that there were six core competency dimensions in each of the two fields, with 20 and 21 item-questions, respectively. After each three-week clinical fieldwork, the self-rating scores in each core competency dimension were higher when compared to those before the course, indicating having better clinical abilities after the lessons. The best self-rating scores were the dimension of attitude and humanistic literacy, and the two lower scores were the dimensions of professional knowledge and skills and problem-solving critical thinking. Conclusions: This study developed questionnaires for clinical fieldwork courses to reflect students' learning outcomes, including the performance of professional knowledge, practice skills, and professional attitudes. The use of self-assessment of learning performance can help students build up their reflective competencies. Teachers can guide students to pay attention to the performance of abilities in each core dimension to enhance the effectiveness of learning through self-reflection and improvement.

Keywords: physical therapy, clinical fieldwork course, learning outcomes assessment, medical education, self-reflection ability

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Authors: Anam Noshaba, Mahr Muhammad Saeed Akhtar

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The aim of this study was to find out the relationship between quality education and organizational culture. The population of this study was all the teachers of Public Degree Colleges located in Punjab. A sample of 400 teachers was selected by using a simple random sampling technique. Quality Education Assessment Questionnaire (QEAQ) and Organizational Culture Assessment Instrument (OCAI) were used for data collection. Out of all, 90% of teachers responded. Findings showed that quality education and organizational culture are positively correlated. Results indicated that there is no difference in quality education and organizational culture by demographic variables of teachers. Future research is needed to study the viewpoint of other stakeholders of education regarding quality education and organizational culture.

Keywords: quality education, minimum quality standards, organizational culture, college level

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Authors: Ng Yen, Shafii Khamis, Rehir Bin Dahalan

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Cyclotrons in the energy range 10-30 MeV are widely used for the production of clincally relevant radiosiotopes used in positron emission tomography (PET) nuclear imaging. Positron emmision tomography is a powerful nuclear imaging tool that produces high quality 3-dimentional images of functional processes of body. The advantage of PET among all other imaging devices is that it allows the study of an impressive array of discrete biochemical and physiologic processes, within a single imaging session. The number of PET scanner increases every year globally due to high clinical demand. However, not all PET centers can afford a cyclotron, due to the expense associated with operation of an in-house cyclotron. Therefore, current research has also focused on the development of parent/daughter generators that can reliably provide PET nuclides. These generators (68Ge/68Ga generator, 62Zn/62Cu, 82Sr/82Rb, etc) can provide even short-lived radionuclides at any time on demand, without the need of an ‘in-house cyclotron’. The parent isotope is produced at a cyclotron/reactor facility, and can be shipped to remote clinical sites (regionally/overseas), where the daughter isotope is eluted, a model similar to the 99Mo/99mTc generator system. The specific aim for this presentation is to talk about the potential for both of the cyclotron and generator-produced PET radiopharmaceuticals used in clinical imaging.

Keywords: positron emission tomography, radiopharmaceutical, cyclotron, generator

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Authors: Abeer Toheed Quadri, Maria Abubakar, Mehreen Sirshar

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Component Based Software Development (CBSD) is a new trend in software development. Selection of quality components is not enough to ensure software quality in Component Based Software System (CBSS). A software product is considered to be a quality product if it satisfies its customer’s needs and has minimum defects. Authors’ survey different research papers and analyzes various techniques which ensure software quality in component based software development. This paper includes an investigation about how to improve the quality of a component based software system without effecting quality attributes. The reported information is identified from literature survey. The developments of component based systems are rising as they reduce the development time, effort and cost by means of reuse. After analysis, it has been explored that in order to achieve the quality in a CBSS we need to have the components that are certified through software measure because the predictability of software quality attributes of system depend on the quality attributes of the constituent components, integration process and the framework used.

Keywords: CBSD (component based software development), CBSS (component based software system), quality components, SQA (software quality assurance)

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Authors: Abdoullah Nyassi, Golam Sarwar, Sarra Baldeh, Mamadou S. K. Jallow, Bai Lamin Dondeh, Isaac Osei, Grant A. Mackenzie

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A randomized controlled trial is the "gold standard" for evaluating the efficacy of an intervention. Large-scale, cluster-randomized trials are expensive and difficult to conduct, though. To guarantee the validity and generalizability of findings, high-quality, dependable, and accurate data management systems are necessary. Robust data management systems are crucial for optimizing and validating the quality, accuracy, and dependability of trial data. Regarding the difficulties of data gathering in clinical trials in low-resource areas, there is a scarcity of literature on this subject, which may raise concerns. Effective data management systems and implementation goals should be part of trial procedures. Publicizing the creative clinical data management techniques used in clinical trials should boost public confidence in the study's conclusions and encourage further replication. In the ongoing pneumococcal vaccine schedule study in rural Gambia, this report details the development and deployment of multi-data management systems and methodologies. We implemented six different data management, synchronization, and reporting systems using Microsoft Access, RedCap, SQL, Visual Basic, Ruby, and ASP.NET. Additionally, data synchronization tools were developed to integrate data from these systems into the central server for reporting systems. Clinician, lab, and field data validation systems and methodologies are the main topics of this report. Our process development efforts across all domains were driven by the complexity of research project data collected in real-time data, online reporting, data synchronization, and ways for cleaning and verifying data. Consequently, we effectively used multi-data management systems, demonstrating the value of creative approaches in enhancing the consistency, accuracy, and reporting of trial data in a poor resource setting.

Keywords: data management, data collection, data cleaning, cluster-randomized trial

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Authors: Malki Nadia Fatima Zahra, Kellal Chaimaa, Brahimi Houria

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Quality is one of the most important modern management patterns that organizations seek to achieve in all areas and sectors in order to meet the needs and desires of customers and to remain continuity, as they constitute a competitive advantage for the organization, and among the most prominent organizations that must be available on the quality factor are health organizations as they relate to the most valuable component of production It is a person and his health, and that any error in it threatens his life and may lead to death, so she must provide health services of high quality to achieve the highest degree of satisfaction for the patient. This research aims to study the quality of health services and the extent of their impact on patient satisfaction, and this is through an applied study that relied on measuring the level of quality of health services in the university hospital center of Algeria and the extent of their impact on patient satisfaction according to the dimensions of the quality of health services, and we reached a conclusion that the determinants of the quality of health services. It affects patient satisfaction, which necessitates developing health services according to patients' requirements and improving their quality to obtain patient satisfaction.

Keywords: health service, health quality, quality determinants, patient satisfaction

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Authors: Sathyaseelan Subramaniam, Jacqueline Bober, Jennifer Chao, Shahriar Zehtabchi

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Background: Emergency physicians frequently evaluate skin and soft tissue infections in order to differentiate abscess from cellulitis. This helps determine which patients will benefit from incision and drainage. Our objective was to determine the operating characteristics of point-of-care ultrasound (POCUS) compared to clinical examination in identifying abscesses in emergency department (ED) patients with features of skin and soft tissue infections. Methods: We performed a comprehensive search in the following databases: Medline, Web of Science, EMBASE, CINAHL and Cochrane Library. Trials were included if they compared the operating characteristics of POCUS with clinical examination in identifying skin and soft tissue abscesses. Trials that included patients with oropharyngeal abscesses or that requiring abscess drainage in the operating room were excluded. The presence of an abscess was determined by pus drainage. No pus seen on incision or resolution of symptoms without pus drainage at follow up, determined the absence of an abscess. Quality of included trials was assessed using GRADE criteria. Operating characteristics of POCUS are reported as sensitivity, specificity, positive likelihood (LR+) and negative likelihood (LR-) ratios and the respective 95% confidence intervals (CI). Summary measures were calculated by generating a hierarchical summary receiver operating characteristic model (HSROC). Results: Out of 3203 references identified, 5 observational studies with 615 patients in aggregate were included (2 adults and 3 pediatrics). We rated the quality of 3 trials as low and 2 as very low. The operating characteristics of POCUS and clinical examination in identifying soft tissue abscesses are presented in the table. The HSROC for POCUS revealed a sensitivity of 96% (95% CI = 89-98%), specificity of 79% (95% CI = 71-86), LR+ of 4.6 (95% CI = 3.2-6.8), and LR- of 0.06 (95% CI = 0.02-0.2). Conclusion: Existing evidence indicates that POCUS is useful in identifying abscesses in ED patients with skin or soft tissue infections.

Keywords: abscess, point-of-care ultrasound, pocus, skin and soft tissue infection

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Authors: Silvija ŠIljeg, Ante ŠIljeg, Ivan Marić

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Measuring housing quality is being done on objective and subjective level using different indicators. During the research 5 urban and housing indicators formed according to 58 variables from different housing, domains were used. The aims of the research were to measure housing quality based on GIS approach and to detect critical points of housing in the example of Croatian coastal Town Zadar. The purposes of GIS in the research are to generate models of housing quality indexes by standardisation and aggregation of variables and to examine accuracy model of housing quality index. Analysis of accuracy has been done on the example of variable referring to educational objects availability. By defining weighted coefficients and using different GIS methods high, middle and low housing quality zones were determined. Obtained results can be of use to town planners, spatial planners and town authorities in the process of generating decisions, guidelines, and spatial interventions.

Keywords: housing quality, GIS, housing quality index, indicators, models of housing quality

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Authors: Tatjana Pekmezovic, Milica Jecmenica-Lukic, Igor Petrovic, Vladimir Kostic

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Background: A group of atypical parkinsonian syndromes (APS) includes a variety of rare neurodegenerative disorders characterized by reduced life expectancy, increasing disability, and considerable impact on health-related quality of life (HRQoL). Aim: In this study we wanted to answer two questions: a) which demographic and clinical factors are main contributors of HRQoL in our cohort of patients with APS, and b) how does quality of life of these patients change over 1-year follow-up period. Patients and Methods: We conducted a prospective cohort study in hospital settings. The initial study comprised all consecutive patients who were referred to the Department of Movement Disorders, Clinic of Neurology, Clinical Centre of Serbia, Faculty of Medicine, University of Belgrade (Serbia), from January 31, 2000 to July 31, 2013, with the initial diagnoses of ‘Parkinson’s disease’, ‘parkinsonism’, ‘atypical parkinsonism’ and ‘parkinsonism plus’ during the first 8 months from the appearance of first symptom(s). The patients were afterwards regularly followed in 4-6 month intervals and eventually the diagnoses were established for 46 patients fulfilling the criteria for clinically probable progressive supranuclear palsy (PSP) and 36 patients for probable multiple system atrophy (MSA). The health-related quality of life was assessed by using the SF-36 questionnaire (Serbian translation). Hierarchical multiple regression analysis was conducted to identify predictors of composite scores of SF-36. The importance of changes in quality of life scores of patients with APS between baseline and follow-up time-point were quantified using Wilcoxon Signed Ranks Test. The magnitude of any differences for the quality of life changes was calculated as an effect size (ES). Results: The final models of hierarchical regression analysis showed that apathy measured by the Apathy evaluation scale (AES) score accounted for 59% of the variance in the Physical Health Composite Score of SF-36 and 14% of the variance in the Mental Health Composite Score of SF-36 (p<0.01). The changes in HRQoL were assessed in 52 patients with APS who completed 1-year follow-up period. The analysis of magnitude for changes in HRQoL during one-year follow-up period have shown sustained medium ES (0.50-0.79) for both Physical and Mental health composite scores, total quality of life as well as for the Physical Health, Vitality, Role Emotional and Social Functioning. Conclusion: This study provides insight into new potential predictors of HRQoL and its changes over time in patients with APS. Additionally, identification of both prognostic markers of a poor HRQoL and magnitude of its changes should be considered when developing comprehensive treatment-related strategies and health care programs aimed at improving HRQoL and well-being in patients with APS.

Keywords: atypical parkinsonian syndromes, follow-up study, quality of life, APS

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Authors: Awole Seid, Yosef Zenebe, Hadgu Gerensea, Kebede Haile Misgina

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Background: Clinical competence is one of the ultimate goals of nursing education. Clinical skills are more than successfully performing tasks; it incorporates client assessment, identification of deficits and the ability to critically think to provide solutions. Assessment of clinical competence, particularly identifying gaps that need improvement and determining the educational needs of nursing students have great importance in nursing education. Thus this study aims determining clinical self-efficacy of final year school of nursing students in three universities of Tigray Region. Methods: A cross-sectional study was conducted on 224 final year school of nursing students from department of nursing, psychiatric nursing, and midwifery on three universities of Tigray region. Anonymous self-administered questionnaire was administered to generate data collected on June, 2017. The data were analyzed using SPSS version 20. The result is described using tables and charts as required. Logistic regression was employed to test associations. Result: The mean age of students was 22.94 + 1.44. Generally, 21% of students have been graduated in the department in which they are not interested. The study demonstrated 28.6% had poor and 71.4% had good perceived clinical self-efficacy. Beside this, 43.8% of psychiatric nursing and 32.6% of comprehensive nursing students have poor clinical self-efficacy. Among the four domains, 39.3% and 37.9% have poor clinical self- efficacy with regard to ‘Professional development’ and ‘Management of care’. Place of the institution [AOR=3.480 (1.333 - 9.088), p=0.011], interest during department selection [AOR=2.202 (1.045 - 4.642), p=.038], and theory-practice gap [AOR=0.224 (0.110 - 0.457), p=0.000] were significantly associated with perceived clinical self-efficacy. Conclusion: The magnitude of students with poor clinically self efficacy was high. Place of institution, theory-practice gap, students interest to the discipline were the significant predictors of clinical self-efficacy. Students from youngest universities have good clinical self-efficacy. During department selection, student’s interest should be respected. The universities and other stakeholders should improve the capacity of surrounding affiliate teaching hospitals to set and improve care standards in order to narrow the theory-practice gap. School faculties should provide trainings to hospital staffs and monitor standards of clinical procedures.

Keywords: clinical self-efficacy, nursing students, Tigray, northern Ethiopia

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Authors: Harsh Panchal, Saurabh Amrutkar

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Quality management is an essential part of any project that has directly related to the performance of a project. Quality management is depended on multiple factors at different stages in a project, right from time management to construction logistics. A project is a mixture of various components that include iternary management, health and safety, crew productivity, and many more. From the survey conducted, we came to the conclusion that advancement in technology and indigenous approach to any project will result in maximum quality standards and better project performance. In this paper, we discuss various components of the factors above that lead to compromise the quality of a project and how it can be controlled in order to achieve maximum quality assurance using quality planning and total quality management. The paper also focuses on limitations and problems faced in each factor responsible for quality management and to tackle them using techniques and processes based on activities and identifying the sequence, approaching critical path, and duration. The project management concept that deals with the sequence of scope cost time give us an overview regarding the ongoing quality management, in a nutshell, giving us hints to regulate the current procedure for maximum achievable quality. It also deals with the problems faced by engineers that make the mundane work process slow, reducing the quality outcome drastically.

Keywords: management, performance, project, quality

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Authors: Aneena Suresh, C. S. Sidharth

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Drug related problems (DRPs) are common in chronic kidney disease (CKD) patients and end stage patients undergoing hemodialysis. To treat the co-morbid conditions of the patients, more complex therapeutic regimen is required, and it leads to development of DRPs. So, this calls for frequent monitoring of the patients. Due to the busy work schedules, physicians are unable to deliver optimal care to these patients. Addition of a clinical pharmacist in the team will improve the standard of care offered to CKD patients by minimizing DRPs. In India, the role of clinical pharmacists in the improving the health outcomes in CKD patients is poorly recognized. Therefore, this study is conducted to put an insight on the role of clinical pharmacist in improving Drug Related Problems in patients with chronic kidney disease, thereby helping them to achieve desired therapeutic outcomes in the patients. A prospective interventional study was conducted for a year in a 620 bedded tertiary care hospital in India. Data was collected using an unstructured questionnaire, medication charts, etc. DRPs were categorized using Hepler and Strand classification. Relationships between the age, weight, GFR, average no of medication taken, average no of comorbidities, and average length of hospital days with the DRPs were identified using Mann Whitney U test. The study population primarily constituted of patients above the age of 50 years with a mean age of 59.91±13.59. Our study showed that 25% of the population presented with DRPs. On an average, CKD patients are prescribed at least 8 medications for the treatment in our study. This explains the high incidence of drug interactions in patients suffering from CKD (45.65%). The least common DRPs in our study were found to be sub therapeutic dose (2%) and adverse drug reactions (2%). Out of this, 60 % of the DRPs were addressed successfully. In our study, there is an association between the DRPs with the average number of medications prescribed, the average number of comorbidities, and the length of the hospital days with p value of 0.022, 0.004, and 0.000, respectively. In the current study, 86% of the proposed interventions were accepted, and 41 % were implemented by the physician, and only 14% were rejected. Hence, it is evident that clinical pharmacist interventions will contribute significantly to diminish the DRPs in CKD patients, thereby decreasing the economic burden of healthcare costs and improving patient’s quality of life.

Keywords: chronic kidney disease, clinical pharmacist, drug related problem, intervention

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Authors: Ozge Yilmaz Kusbeci, Ipek Inci

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Aim: Musculoskeletal problems are very common in Parkinson’s disease (PD). They affect quality of life and cause disabilities. However they are under-evaluated, and under-treated. The aim of this study is to evaluate the prevalence and clinical features of musculoskeletal problems in patients with Parkinson disease (PD) compared to controls. Methods: 50 PD patients and 50 age and sex matched controls were interviewed by physicians about their musculoskeletal problems. Results: The prevalence of musculoskeletal problems was significantly higher in the PD group than in the control group (p < 0.05). Commonly involved body sites were the shoulder, low back, and knee. The shoulder and low back was more frequently involved in the PD group than in the control group. However, the knee was similarly involved in both groups. Among the past diagnoses associated with musculoskeletal problems, frozen shoulder, low back pain and osteoporosis more common in the PD group than in the control group (p < 0.05). Furthermore, musculoskeletal problems in the PD group tended to receive less treatment than that of the control group. Conclusion: Musculoskeletal problems were more common in the PD group than in the controls. Therefore assessment and treatment of musculoskeletal problems could improve quality of life in PD patients.

Keywords: parkinson disease, musculoskeletal problems, quality of life, PD disease

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Authors: Ibraheem Husain, Abul Kalam Najmi, Karishma Chester

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First-in-human (FIH) studies are a critical step in clinical development of any molecule that has shown therapeutic promise in preclinical evaluations, since preclinical research and safety studies into clinical development is a crucial step for successful development of monoclonal antibodies for guidance in pharmaceutical industry for the treatment of human diseases. Therefore, comparison between USFDA and nine pharmacologically guided approaches (PGA) (simple allometry, maximum life span potential, brain weight, rule of exponent (ROE), two species methods and one species methods) were made to determine maximum recommended starting dose (MRSD) for first in human clinical trials using four drugs namely Denosumab, Bevacizumab, Anakinra and Omalizumab. In our study, the predicted pharmacokinetic (pk) parameters and the estimated first-in-human dose of antibodies were compared with the observed human values. The study indicated that the clearance and volume of distribution of antibodies can be predicted with reasonable accuracy in human and a good estimate of first human dose can be obtained from the predicted human clearance and volume of distribution. A pictorial method evaluation chart was also developed based on fold errors for simultaneous evaluation of various methods.

Keywords: clinical pharmacology (CPH), clinical research (CRE), clinical trials (CTR), maximum recommended starting dose (MRSD), clearance and volume of distribution

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Authors: Ji-Chan Jang

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Tuberculosis is still major health problem because there is an increase of multidrug-resistant and extensively drug-resistant forms of the disease. Therefore, the most urgent clinical need is to discover potent agents and develop novel drug combination capable of reducing the duration of MDR and XDR tuberculosis therapy. Three reference strains H37Rv, CDC1551, W-Beijing GC1237 and six clinical isolates of MDRTB were tested to daptomycin in the range of 0.013 to 256 mg/L. Daptomycin is resistant to all tested M. tuberculosis strains not only laboratory strains but also clinical MDR strains that were isolated at different source. Daptomycin will not be an antibiotic of choice for treating infection of Gram positive atypical slowly growing M. tuberculosis.

Keywords: tuberculosis, daptomycin, resistance, Mycobacterium tuberculosis

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Authors: Hwang Kwon

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Objective: To assess the efficacy of embryo transfer (ET) of accumulated vitrified embryos and compare pregnancy outcomes between ET of thawed embryos following accumulation of vitrified embryos (frozen ET) and ET of fresh and thawed frozen embryos following accumulation of vitrified embryos (fresh ET + frozen ET). Study design: Patients were poor ovarian responders defined according to the Bologna criteria as well as a subgroup of women whose previous IVF-ET cycle through controlled ovarian stimulation (COS) yielded one or no embryos. Sixty-four frozen ETs were performed following accumulation of vitrified embryos (ACCE )(ACCE Frozen) and 51 fresh + frozen ETs were performed following accumulation of vitrified embryos (ACCE Fresh + Frozen). Positive βhCG rate, clinical pregnancy rate, ongoing pregnancy rate, and good quality embryos (%, ±SD) were compared between two groups. Results: There were more good quality embryos in the ACCE Fresh + Frozen group than in the ACCE Frozen group: 60±34.7 versus 42.9±28.9, respectively (p=0.03). Positive βhCG rate [18/64(28.2%) vs. 13/51(25.5%); p=0.75] and clinical pregnancy rate [12/64 (18.8%) vs. 11/51 (10.9%); p=0.71] were comparable between the two groups. Conclusion: Accumulation of vitrified embryos is an effective method in patients with poor ovarian response who fulfill the Bologna criteria. Pregnancy outcomes were comparable between the two groups.

Keywords: accumulation of embryos, frozen embryo transfer, poor responder, Bologna criteria

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Authors: Anamika A. Sharma, Arezou Ahmadi R. A., Narendra B. Parihar, Manjusha Sajith

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Introduction: Hemodialysis is the most effective therapeutic technique for patient with ESRD second to renal transplantation. However it is a lifelong therapy which requires frequent hospital, or dialysis centers visits mainly twice and thrice weekly, thus considerably changes the normal way of patient’s living. So this study aimed to Assess Health-Related Quality of life in End-Stage Renal Disease (ESRD) Undergoing Twice and Thrice weekly Hemodialysis. Method: A prospective observational, cross-sectional study was carried out from September 2016 to April 2017 in end-stage renal disease patients undergoing hemodialysis. Socio-demographic and clinical details of patients were obtained from the medical records. WHOQOL-BREF questionnaire was used to Access Health-Related Quality Of Life. Quality of Life scores of Twice weekly and Thrice weekly hemodialysis was analyzed by Kruskal Wallis Test. Results: Majority of respondents were male (72.55%), married (89.31%), employed (58.02%), belong to middle class (71.00%) and resides in rural area (58.78%). The mean ages in the patient undergoing twice weekly and thrice weekly hemodialysis were 51.89 ± 15.64 years and 51.33 ± 15.70 years respectively. Average Quality of Life scores observed in twice weekly and thrice weekly hemodialysis was 52.07 ± 13.30 (p=0.0037) and 52.87 ± 13.47 (p=0.0004) respectively. The hemoglobin of thrice weekly dialysis patients (10.28 gm/dL) was high as compared to twice weekly dialysis (9.23 gm/dL). Patients undergoing thrice weekly dialysis had improved serum urea, serum creatinine values (95.85 mg/dL, 8.32 mg/dL) as compared to twice weekly hemodialysis ( 104.94 mg/dL, 8.68 mg/dL). Conclusion: Our study concluded that there was no significant difference between overall Health-Related Quality Of Life in twice weekly and thrice weekly hemodialysis. Frequent hemodialysis was associated with improved control of hypertension, serum urea, serum creatinine levels.

Keywords: end stage renal disease, health related quality of life, twice weekly hemodialysis, thrice weekly hemodialysis

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Authors: Joseph Roberson, Carina Kleynhans, Willie Coetzee

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The low entry barriers of the restaurant industry lead to an extremely competitive business environment. In this volatile business sector it is of the utmost importance to implement a strategy of quality differentiation. Vital aspects of a quality differentiation strategy are total quality management, benchmarking and service quality management. Ultimately, restaurant success depends on the continuous support of customers. Customers select restaurants based on their expectations of quality. If the customers' expectations are met, they perceive quality service and will re-patronize the restaurant. The restaurateur can manage perceptions of quality by influencing expectations while ensuring that those expectations are not inflated. The management of expectations can be done by communicating service quality to customers. The aim of this research paper is to describe the development of a grading process for restaurants. An assessment of the extensive body of literature on grading was conducted through content analysis. A standardized method for developing a grading system would assist in successful grading systems that could inform both customers and restaurateurs of restaurant quality.

Keywords: benchmarking, restaurants, grading, service quality, total quality management

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Authors: Atul Dev, Pankaj Jha

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Dr. Genichi Taguchi looked at quality in a broader term and gave an excellent definition of quality in terms of loss to society. However the scope of this definition is limited to the losses imparted by a poor quality product to the customer only and are considered during the useful life of the product and further in a certain situation this loss can even be zero. In this paper, it has been proposed that the scope of quality of a product shall be further enhanced by considering the losses imparted by a poor quality product to society at large, due to associated environmental and safety related factors, over the complete life cycle of the product. Moreover, though these losses can be further minimized with the use of techno-safety interventions, the net losses to society however can never be made zero. This paper proposes an entirely new approach towards defining product quality and is based on Taguchi’s definition of quality.

Keywords: existing concept, goal post philosophy, life cycle, proposed concept, quality loss function

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Authors: Urszula Malaga-Toboła, Marek Gugała, Rafał Kornas, Robert Rusinek, Marek Gancarz

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The work focused on presenting the elements that determine the quality of fresh milk in the context of the quality of its transport. The quality of the raw material depends on the quality of transport. Milk transport involves many activities in which, apart from the temperature and sterility of the means of transport, it is important not to expose the raw material to shocks. Recently, there have been changes in the milk supply chain, thus affecting the logistics processes between its links. Based on the conducted research and analyses, it was found that the condition of the road surface on which milk is transported affects its quality. For the T1 milk transport route- gravel roads of very poor and poor quality, the lowest number of bacteria and the highest number of somatic cells, fat content, and temperature of the transported milk were obtained. A well-organized integrated transport system is a real need for most companies today. The analysis showed significant differences in the quality of milk delivered to the dairy.

Keywords: fresh milk, transport, milk quality, dairy

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Authors: Parastoo Parhizkar, Jaber Yaghini, Omid Fakheran

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Background: Third molar surgery is often associated with postoperative problems which cause serious impediments on daily activities and quality of life. Steroidal anti-inflammatory drugs may decrease these common post-operative complications. The purpose of this review is evaluating the available evidence regarding the efficacy of corticosteroids used as adjunctive therapy for patients undergoing third molar surgery. Methods: PubMed, Google scholar, Scopus, web of science, clinicaltrials.gov, scirus.com, Cochrane central register for controlled trials, LILACS, OpenGrey, centerwatch, isrctn, who.int and ebsco were searched without restrictions regarding the year of publication. Randomized clinical trials assessing patient-reported outcomes in patients undergoing surgical therapy, were eligible for inclusion. Study quality was assessed using the CONSORT-checklist. No meta-analysis was performed. Results: A total of twelve Randomized Clinical Trials were included in this study. Methylprednisolone and Dexamethasone may decrease postoperative side effects such as pain, trismus and edema. Based on the results both of them could improve patients’ satisfaction, and there is no significant difference between these two types of corticosteroids regarding the patient centered outcomes (p > 0.05). Intralesional and intravenous injection of Dexamethasone showed an equivalent result, with statistically significant better results (P < 0.05) in comparison with the oral treatment. Conclusion: various types of corticosteroids can enhance the patient’s satisfaction following third molar surgery. However, there is no significant difference between Dexamethasone, Prednisolone and Methylprednisolone groups in this regard. Comparing the various administration routs, local injection of Dexamethasone is quite simple, painless and cost-effective adjunctive therapy with better drug efficacy.

Keywords: third molar surgery, corticosteroids, patient-reported outcomes, health related quality of life

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