Search results for: clinical laboratory results

Authors: Mari A. Virtanen, Elina Haavisto, Eeva Liikanen, Maria Kääriäinen

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Rapid technological development and digitalization has affected also on higher education. During last twenty years multiple of electronic and mobile learning (e-learning, m-learning) platforms have been developed and have become prevalent in many universities and in the all fields of education. Ubiquitous learning (u-learning) is not that widely known or used. Ubiquitous learning environments (ULE) are the new era of computer-assisted learning. They are based on ubiquitous technology and computing that fuses the learner seamlessly into learning process by using sensing technology as tags, badges or barcodes and smart devices like smartphones and tablets. ULE combines real-life learning situations into virtual aspects and can be flexible used in anytime and anyplace. The aim of this study was to assess the effects of ubiquitous 360 o learning environment on higher education students’ clinical histotechnology competence. A quasi-experimental study design was used. 57 students in biomedical laboratory science degree program was assigned voluntarily to experiment (n=29) and to control group (n=28). Experimental group studied via ubiquitous 360o learning environment and control group via traditional web-based learning environment (WLE) in a 8-week educational intervention. Ubiquitous 360o learning environment (ULE) combined authentic learning environment (histotechnology laboratory), digital environment (virtual laboratory), virtual microscope, multimedia learning content, interactive communication tools, electronic library and quick response barcodes placed into authentic laboratory. Web-based learning environment contained equal content and components with the exception of the use of mobile device, interactive communication tools and quick response barcodes. Competence of clinical histotechnology was assessed by using knowledge test and self-report developed for this study. Data was collected electronically before and after clinical histotechnology course and analysed by using descriptive statistics. Differences among groups were identified by using Wilcoxon test and differences between groups by using Mann-Whitney U-test. Statistically significant differences among groups were identified in both groups (p<0.001). Competence scores in post-test were higher in both groups, than in pre-test. Differences between groups were very small and not statistically significant. In this study the learning environment have developed based on 360o technology and successfully implemented into higher education context. And students’ competence increases when ubiquitous learning environment were used. In the future, ULE can be used as a learning management system for any learning situation in health sciences. More studies are needed to show differences between ULE and WLE.

Keywords: competence, higher education, histotechnology, ubiquitous learning, u-learning, 360o

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Authors: Lina T. Codilla

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This study primarily designed a laboratory activity in ecology to demonstrate the allelopathic property of the Philippine Chromolaena odorata L. (hagonoy) leaf extracts to Lycopersicum esculentum (M), commonly known as tomatoes. Ethanol extracts of C. odorata leaves were tested on seed germination and seedling growth of L. esculentum in 7-day and 14-day observation periods. Analysis of variance and Tukey’s HSD post hoc test was utilized to determine differences among treatments while Pre–test – Post–test experimental design was utilized in the determination of the effectiveness of the designed laboratory activity. Results showed that the 0.5% concentration level of ethanol leaf extracts significantly inhibited germination and seedling growth of L. esculentum in both observation periods. These results were used as the basis in the development of instructional material in ecology. The laboratory activity underwent face validation by five (5) experts in various fields of specialization, namely, Biological Sciences, Chemistry and Science Education. The readability of the designed laboratory activity was determined using a Cloze Test. Pilot testing was conducted and showed that the laboratory activity developed is found to be a very effective tool in supplementing learning about allelopathy in ecology class. Thus, it is recommended for use among ecology classes but modification will be made in a small – scale basis to minimize time consumption.

Keywords: allelopathy, chromolaena odorata l. (hagonoy), designed-laboratory activity, organic herbicide students’ performance

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Authors: Shivalal Sharma, Sanjib K. Sharma, Madhab Lamsal

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Background: The aim of this study was to evaluate the clinical and laboratory changes three months after full-mouth scaling and root planing (SRP) in periodontitis patients with type 2 diabetes mellitus (DM). Methods: Forty-seven type 2 DM subjects with moderate to severe periodontitis were randomly divided into two groups. Treatment group (TG), 25 subjects, received full-mouth scaling and root planning; control group (CG), 22 subjects, received no treatment. At baseline and at the end of three months, glycated hemoglobin (HbA1c) values, fasting glucose, and clinical parameters like plaque index (PI), gingival index (GI), probing pocket depth (PPD), and clinical attachment level (CAL) were recorded in all the patients. Following SRP, the patients were enrolled in a monthly interval maintenance program for 3 months. Results: A statistically significant effect could be demonstrated for PI, GI, PPD, and CAL for the treatment group. HbA1c levels in the treatment group decreased significantly whereas the control group showed a slight but insignificant increase for these parameters. Conclusions: The results of this study showed that non-surgical periodontal treatment (SRP) is associated with improved glycemic control in type 2 DM patients and could be undertaken along with the standard measures for the diabetic patient care.

Keywords: periodontitis, type 2 diabetes mellitus, non-surgical periodontal therapy, SRP

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Authors: Irvan Adhin Cholilie, Susinggih Wijana, Yusron Sugiarto

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The aim of this research is to compare the results of black grass jelly produced using laboratory scale and double scale. In this research, the production from the laboratory scale is using ingredients of 1 kg black grass jelly added with 5 liters of water, while the double scale is using 5 kg black grass jelly and 75 liters of water. The results of organoleptic tests performed by 30 panelists (general) to the sample gels of grass black powder produced from both of laboratory and double scale are not different significantly in color, odor, flavor, and texture. Proximate test results conducted in both of grass black jelly powder produced in laboratory scale and double scale also have no significant differences in all parameters. Grass black jelly powder from double scale contains water, carbohydrate, crude fiber, and yield in the amount of 12,25 %; 43,7 %; 5,89 %; and 16,28 % respectively. The results of the energy efficiency analysis by boiling, draining, evaporation, drying, and milling processes are 85,11 %; 76,97 %; 99,64 %; 99,99% and 99,39% respectively. The utility needs including water needs for each batch amounted 0.1 m3 and cost Rp 220,5 per batch, the electricity needs for each batch is 20.01 kWh and cost Rp 18569.28 per batch, and LPG needs for each batch is 30 kg costed Rp 234,000.00 so that the total cost spent for the process is Rp 252,789.78 .

Keywords: black grass jelly, powder, mass balance, energy balance, cost

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Authors: Golyasamin Khanehzaei, Mohd. Bakri Ishak, Ahmad Makmom Hj Abdullah, Latifah Abd Manaf

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Abstract—Management of clinical waste is a critical problem worldwide. Immediate attention is required to manage the clinical waste in an appropriate way in newly developing economy country such as Malaysia. The increasing amount of clinical waste generated is resulted from rapid urbanization and growing number of private health care facilities in developing countries such as Malaysia. In order to develop a sensible clinical waste management system and improvement of the management, information on factors affecting clinical waste generation has the crucial role. This paper is the study of management characteristics of clinical waste and the level of efficiency of clinical waste management systems operating in private clinics located in Selangor, Malaysia. Are they following the proper international standards? By taking all of this in consideration the aim of this paper is to identify and discuss the current trend, current challenges and also the present opportunities among the challenges of clinical waste management in private clinics of Selangor, Malaysia. The SWOT analysis was characterized for the evaluation of strengths, weaknesses, opportunities and threats. The methodology for this study was constituted of direct observation, Informal interviews, Conducting SWOT analysis, conduction of one sustainability dimensions analysis and application. The results show that clinical waste management in private clinics is far from an ideal model.

Keywords: clinical waste, SWOT analysis, Selangor, Malaysia

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Authors: Yong Hwang, Kang Yeol Suh, Yundeok Jang, Tae Hoon Kim

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Introduction: Rhabdomyolysis is a syndrome characterized by muscle necrosis and the release of intracellular muscle constituents into the circulation. Acute kidney injury is a potential complication of severe rhabdomyolysis and the prognosis is substantially worse if renal failure develops. We try to identify the factors that were predictive of AKI in severe trauma patients with rhabdomyolysis. Methods: This retrospective study was conducted at the emergency department of a level Ⅰ trauma center. Patients enrolled that initial creatine phosphokinase (CPK) levels were higher than 1000 IU with acute multiple trauma, and more than 18 years older from Oct. 2012 to June 2016. We collected demographic data (age, gender, length of hospital day, and patients’ outcome), laboratory data (ABGA, lactate, hemoglobin. hematocrit, platelet, LDH, myoglobin, liver enzyme, and BUN/Cr), and clinical data (Injury Mechanism, RTS, ISS, AIS, and TRISS). The data were compared and analyzed between AKI and Non-AKI group. Statistical analyses were performed using IMB SPSS 20.0 statistics for Window. Results: Three hundred sixty-four patients were enrolled that AKI group were ninety-six and non-AKI group were two hundred sixty-eight. The base excess (HCO3), AST/ALT, LDH, and myoglobin in AKI group were significantly higher than non-AKI group from laboratory data (p ≤ 0.05). The injury severity score (ISS), revised Trauma Score (RTS), Abbreviated Injury Scale 3 and 4 (AIS 3 and 4) were showed significant results in clinical data. The patterns of CPK level were increased from first and second day, but slightly decreased from third day in both group. Seven patients had received hemodialysis treatment despite the bleeding risk and were survived in AKI group. Conclusion: We recommend that HCO3, CPK, LDH, and myoglobin should be checked and be concerned about ISS, RTS, AIS with injury mechanism at the early stage of treatment in the emergency department.

Keywords: acute kidney injury, emergencies, multiple trauma, rhabdomyolysis

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Authors: Sukriti Sabharwal, Sonali Bhattar, Shikhar Saxena

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Introduction: COVID-19 molecular diagnostic laboratory is the cornerstone of the COVID-19 disease diagnosis as the patient’s treatment and management protocol depend on the molecular results. For this purpose, it is extremely important that the laboratory conducting these results adheres to the quality management processes to increase the accuracy and validity of the reports generated. We started our own molecular diagnostic setup at the onset of the pandemic. Therefore, we conducted this study to generate our quality management data to help us in improving on our weak points. Materials and Methods: A total of 14561 samples were evaluated by the retrospective observational method. The quality variables analysed were classified into pre-analytical, analytical, and post-analytical variables, and the results were presented in percentages. Results: Among the pre-analytical variables, sample leaking was the most common cause of the rejection of samples (134/14561, 0.92%), followed by non-generation of SRF ID (76/14561, 0.52%) and non-compliance to triple packaging (44/14561, 0.3%). The other pre-analytical aspects assessed were incomplete patient identification (17/14561, 0.11%), insufficient quantity of samples (12/14561, 0.08%), missing forms/samples (7/14561, 0.04%), samples in the wrong vials/empty VTM tubes (5/14561, 0.03%) and LIMS entry not done (2/14561, 0.01%). We are unable to obtain internal quality control in 0.37% of samples (55/14561). We also experienced two incidences of cross-contamination among the samples resulting in false-positive results. Among the post-analytical factors, a total of 0.07% of samples (11/14561) could not be dispatched within the stipulated time frame. Conclusion: Adherence to quality control processes is foremost for the smooth running of any diagnostic laboratory, especially the ones involved in critical reporting. Not only do the indicators help in keeping in check the laboratory parameters but they also allow comparison with other laboratories.

Keywords: laboratory quality management, COVID-19, molecular diagnostics, healthcare

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Authors: Raj Chandran, Saul Datwyler, Jaime Marino, Daniel West, Karla Grasso, Adam Buss, Hina Syed, Zina Al Sahouri, Jennifer Yen, Krista Caudle, Beth McQuiston

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The Alinity i TBI test is Therapeutic Goods Administration (TGA) registered and is a panel of in vitro diagnostic chemiluminescent microparticle immunoassays for the measurement of glial fibrillary acidic protein (GFAP) and ubiquitin C-terminal hydrolase L1 (UCH-L1) in plasma and serum. The Alinity i TBI performance was evaluated in a multi-center pivotal study to demonstrate the capability to assist in determining the need for a CT scan of the head in adult subjects (age 18+) presenting with suspected mild TBI (traumatic brain injury) with a Glasgow Coma Scale score of 13 to 15. TBI has been recognized as an important cause of death and disability and is a growing public health problem. An estimated 69 million people globally experience a TBI annually1. Blood-based biomarkers such as glial fibrillary acidic protein (GFAP) and ubiquitin C-terminal hydrolase L1 (UCH-L1) have shown utility to predict acute traumatic intracranial injury on head CT scans after TBI. A pivotal study using prospectively collected archived (frozen) plasma specimens was conducted to establish the clinical performance of the TBI test on the Alinity i system. The specimens were originally collected in a prospective, multi-center clinical study. Testing of the specimens was performed at three clinical sites in the United States. Performance characteristics such as detection limits, imprecision, linearity, measuring interval, expected values, and interferences were established following Clinical and Laboratory Standards Institute (CLSI) guidance. Of the 1899 mild TBI subjects, 120 had positive head CT scan results; 116 of the 120 specimens had a positive TBI interpretation (Sensitivity 96.7%; 95% CI: 91.7%, 98.7%). Of the 1779 subjects with negative CT scan results, 713 had a negative TBI interpretation (Specificity 40.1%; 95% CI: 37.8, 42.4). The negative predictive value (NPV) of the test was 99.4% (713/717, 95% CI: 98.6%, 99.8%). The analytical measuring interval (AMI) extends from the limit of quantitation (LoQ) to the upper LoQ and is determined by the range that demonstrates acceptable performance for linearity, imprecision, and bias. The AMI is 6.1 to 42,000 pg/mL for GFAP and 26.3 to 25,000 pg/mL for UCH-L1. Overall, within-laboratory imprecision (20 day) ranged from 3.7 to 5.9% CV for GFAP and 3.0 to 6.0% CV for UCH-L1, when including lot and instrument variances. The Alinity i TBI clinical performance results demonstrated high sensitivity and high NPV, supporting the utility to assist in determining the need for a head CT scan in subjects presenting to the emergency department with suspected mild TBI. The GFAP and UCH-L1 assays show robust analytical performance across a broad concentration range of GFAP and UCH-L1 and may serve as a valuable tool to help evaluate TBI patients across the spectrum of mild to severe injury.

Keywords: biomarker, diagnostic, neurology, TBI

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Authors: N. Bolong, J. Makinda, I. Saad

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Laboratory activities have produced benefits in student learning. With current drives of new technology resources and evolving era of education methods, renewal status of learning and teaching in laboratory methods are in progress, for both learners and the educators. To enhance learning outcomes in laboratory works particularly in engineering practices and testing, learning via hands-on by instruction may not sufficient. This paper describes and compares techniques and implementation of traditional (expository) with open-ended laboratory (problem-based) for two consecutive cohorts studying environmental laboratory course in civil engineering program. The transition of traditional to problem-based findings and effect were investigated in terms of course assessment student feedback survey, course outcome learning measurement and student performance grades. It was proved that students have demonstrated better performance in their grades and 12% increase in the course outcome (CO) in problem-based open-ended laboratory style than traditional method; although in perception, students has responded less favorable in their feedback.

Keywords: engineering education, open-ended laboratory, environmental engineering lab

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Authors: Tambe Daniel Atem

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Background: Clinical Research is an organized research on human beings intended to provide adequate information on the drug use as a therapeutic agent on its safety and efficacy. The significance of the study is to educate the global health and life science graduates in Clinical Research in depth to perform better as it involves testing drugs on human beings. Objectives: to provide an overall understanding of the scientific approach to the evaluation of new and existing medical interventions and to apply ethical and regulatory principles appropriate to any individual research. Methodology: It is based on – Primary data analysis and Secondary data analysis. Primary data analysis: means the collection of data from journals, the internet, and other online sources. Secondary data analysis: a survey was conducted with a questionnaire to interview the Clinical Research Professionals to understand the need of training to perform clinical trials globally. The questionnaire consisted details of the professionals working with the expertise. It also included the areas of clinical research which needed intense training before entering into hardcore clinical research domain. Results: The Clinical Trials market worldwide worth over USD 26 billion and the industry has employed an estimated 2,10,000 people in the US and over 70,000 in the U.K, and they form one-third of the total research and development staff. There are more than 2,50,000 vacant positions globally with salary variations in the regions for a Clinical Research Coordinator. R&D cost on new drug development is estimated at US$ 70-85 billion. The cost of doing clinical trials for a new drug is US$ 200-250 million. Due to an increase trained Clinical Research Professionals India has emerged as a global hub for clinical research. The Global Clinical Trial outsourcing opportunity in India in the pharmaceutical industry increased to more than $2 billion in 2014 due to increased outsourcing from U.S and Europe to India. Conclusion: Assessment of training need is recommended for newer Clinical Research Professionals and trial sites, especially prior the conduct of larger confirmatory clinical trials.

Keywords: clinical research, clinical trials, clinical research professionals

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Authors: Mercy Okezue, Kari Clase, Stephen Byrn, Paddy Shivanand

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Medicines regulatory authorities expect pharmaceutical companies and contract research organizations to seek ways to certify that their laboratory control measurements are reliable. Establishing and maintaining laboratory quality standards are essential in ensuring the accuracy of test results. ‘ISO/IEC 17025:2017’ and ‘WHO Good Practices for Pharmaceutical Quality Control Laboratories (GPPQCL)’ are two quality standards commonly employed in developing laboratory quality systems. A review was conducted on the two standards to elaborate on areas on convergence and divergence. The goal was to understand how differences in each standard's requirements may influence laboratories' choices as to which document is easier to adopt for quality systems. A qualitative review method compared similar items in the two standards while mapping out areas where there were specific differences in the requirements of the two documents. The review also provided a detailed description of the clauses and parts covering management and technical requirements in these laboratory standards. The review showed that both documents share requirements for over ten critical areas covering objectives, infrastructure, management systems, and laboratory processes. There were, however, differences in standard expectations where GPPQCL emphasizes system procedures for planning and future budgets that will ensure continuity. Conversely, ISO 17025 was more focused on the risk management approach to establish laboratory quality systems. Elements in the two documents form common standard requirements to assure the validity of laboratory test results that promote mutual recognition. The ISO standard currently has more global patronage than GPPQCL.

Keywords: ISO/IEC 17025:2017, laboratory standards, quality control, WHO GPPQCL

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Authors: Olayinka Risiquat Raimi

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

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

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Authors: Ramy Shaaban

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The purpose of this study was to examine the difference in clinical reasoning skills of students when using virtual audiology cases with and without collaborative assistance from major learning approaches important to clinical reasoning skills and computer-based learning models: Situated Learning Theory, Social Development Theory, Scaffolding, and Collaborative Learning. A quasi-experimental design was conducted at two United States universities to examine whether there is a significant difference in clinical reasoning skills between three treatment groups using IUP Audiosim software. Two computer-based audiology case simulations were developed, and participants were randomly placed into the three groups: no collaboration, virtual collaboration, and live collaboration. The clinical reasoning data were analyzed using One-Way ANOVA and Tukey posthoc analyses. The results show that there was a significant difference in clinical reasoning skills between the three treatment groups. The score obtained by the no collaboration group was significantly less than the scores obtained by the virtual and live collaboration groups. Collaboration, whether virtual or in person, has a positive effect on students’ clinical reasoning. These results with audiology students indicate that combining collaboration models with scaffolding and embedding situated learning and social development theories into the design of future virtual patients has the potential to improve students’ clinical reasoning skills.

Keywords: clinical reasoning, virtual patients, collaborative learning, scaffolding

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Authors: Valerie A. Conrade

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Introduction: A large body of literature suggests patients who complete fecal immunochemical testing (FIT) kits are likely to identify colorectal cancer sooner than those who do not complete FIT kits. Background: Patients who do not participate in preventative measures such as the FIT kit are at a higher risk of colorectal cancer growing unnoticed. The objective was to see if the method the principal investigator (PI) uses to educate clinical staff on the importance of FIT kit administration provides an increased amount of FIT kit dissemination to patients post clinical education. Methodologies: Data collection via manual tallies took place before and after the clinical staff was educated on the importance of FIT kits. Results: The results showed an increase in FIT kit dissemination post clinical staff education. Through enhanced instruction to the clinical staff regarding the importance of FIT kits, expanding their knowledge on preventative measures to detect colorectal cancer positively impacted nurses and, in turn, their patients.

Keywords: colon cancer, education, fecal immunochemical testing, nursing

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Authors: Seyed Abolhasan Naeini, Eisa Aliagahei

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Today, the use of geosynthetic materials in geotechnical activities is increasing significantly. One of the main uses of these materials is to increase the compressive strength of clay reinforced by geotextile layers. In the present study, the effect of clay reinforcement by geotextile layers in increasing the compressive strength of clay has been investigated using modeling in ABAQUS 6.11.3 software. For this purpose, the modified Drager Prager model has been chosen to simulate the stress-strain behavior of soil layers and the linear elastic model for the geotextile layer. Unreinforced samples and reinforced samples are modeled by geotextile layers (1, 2 and 3 geotextile layers) by software. In order to validate the results, an article in the same field was used and the numerical modeling results were calibrated with the laboratory results. Based on the obtained results, the software has a suitable capability for modeling and the results of the numerical model overlap with the laboratory results to a very acceptable extent, by increasing the number of geotextile layers, the error between the results of the laboratory sample and the software model increases. The highest amount of error is related to the sample reinforced with three layers of geotextile and is 7.3%.

Keywords: Abaqus, cap model, clay, geotextile layer, reinforced soil

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Authors: Reena K., Mamatha H. G., Somshekarayya, P. Kumar

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Objectives: The annual proficiency testing of intermediate reference laboratories is conducted by the National Reference Laboratory (NRL) to assess the efficiency of the laboratories to correctly identify Mycobacterium tuberculosis and to determine its drug susceptibility pattern. The proficiency testing results from 2013 to 2017 were analyzed to determine laboratories that were consistent in reporting quality results and those that had difficulty in doing so. Methods: A panel of twenty cultures were sent out to each of these laboratories. The laboratories were expected to grow the cultures in their own laboratories, set up drug susceptibly testing by all the methods they were certified for and report the results within the stipulated time period. The turnaround time for reporting results, specificity, sensitivity positive and negative predictive values and efficiency of the laboratory in identifying the cultures were analyzed. Results: Most of the laboratories had reported their results within the stipulated time period. However, there was enormous delay in reporting results from few of the laboratories. This was mainly due to improper functioning of the biosafety level III laboratory. Only 40% of the laboratories had 100% efficiency in solid culture using Lowenstein Jensen medium. This was expected as a solid culture, and drug susceptibility testing is not used for diagnosing drug resistance. Rapid molecular methods such as Line probe assay and Genexpert are used to determine drug resistance. Automated liquid culture system such as the Mycobacterial growth indicator tube is used to determine prognosis of the patient while on treatment. It was observed that 90% of the laboratories had achieved 100% in the liquid culture method. Almost all laboratories had achieved 100% efficiency in the line probe assay method which is the method of choice for determining drug-resistant tuberculosis. Conclusion: Since the liquid culture and line probe assay technologies are routinely used for the detection of drug-resistant tuberculosis the laboratories exhibited higher level of efficiency as compared to solid culture and drug susceptibility testing which are rarely used. The infrastructure of the laboratory should be maintained properly so that samples can be processed safely and results could be declared on time.

Keywords: annual proficiency testing, drug susceptibility testing, intermediate reference laboratory, national reference laboratory

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Authors: Nigmet Koklu, Dundar Yener

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Recently, distance education that make use of web technology is used widely all around the world to overcome geographical and time based problems in education. Graphics, animation and other auxiliary visual sources help student to understand the subjects easily. Especially some theoretical courses that are quite difficult to understand such as physics and chemistry require visual material for students to understand topics clearly. In this study, physics applications for laboratory of physics course were developed. All facilities of web-based educational technology were used for students in laboratory studies to avoid making mistakes and to learn better physics subjects.

Keywords: physics education, laboratory, web-based education, distance education

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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: Cengiz Demir, Recep Keşli, Gülşah Aşık

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Objective: This study was carried out with the purpose of defining by using the E test method and determining the antibiotic resistance profiles of Gram-negative anaerobic bacilli isolated from various clinical specimens obtained from patients with suspected anaerobic infections and referred to Medical Microbiology Laboratory of Afyon Kocatepe University, ANS Application and Research Hospital. Methods: Two hundred and seventy eight clinical specimens were examined for isolation of the anaerobic bacteria in Medical Microbiology Laboratory between the 1st November 2014 and 30th October 2015. Specimens were cultivated by using Scheadler agar that 5% defibrinated sheep blood added, and Scheadler broth. The isolated anaerobic Gram-negative bacilli were identified conventional methods and Vitek 2 (ANC ID Card, bioMerieux, France) cards. Antibiotic resistance rates against to penicillin G, clindamycin, cefoxitin, metronidazole, moxifloxacin, imipenem, meropenem, ertapenem and doripenem were determined with E-test method for each isolate. Results: Of the isolated twenty-eight anaerobic gram negative bacilli fourteen were identified as the B. fragilis group, 9 were Prevotella group, and 5 were Fusobacterium group. The highest resistance rate was found against penicillin (78.5%) and resistance rates against clindamycin and cefoxitin were found as 17.8% and 21.4%, respectively. Against to the; metronidazole, moxifloxacin, imipenem, meropenem, ertapenem and doripenem, no resistance was found. Conclusion: Since high rate resistance has been detected against to penicillin in the study penicillin should not be preferred in empirical treatment. Cefoxitin can be preferred in empirical treatment; however, carrying out the antibiotic sensitivity testing will be more proper and beneficial. No resistance was observed against carbapenem group antibiotics and metronidazole; so that reason, these antibiotics should be reserved for treatment of infectious caused by resistant strains in the future.

Keywords: anaerobic gram-negative bacilli, anaerobe, antibiotics and resistance profiles, e-test method

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Authors: Yenni Kurniawati

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Students Prediction Skill in chemistry experiments is an important skill for pre-service chemistry students to stimulate students reflective thinking at each stage of many chemistry experiments, qualitatively and quantitatively. A Virtual Chemistry Laboratory was designed to give students opportunities and times to practicing many kinds of chemistry experiments repeatedly, everywhere and anytime, before they do a real experiment. The Virtual Chemistry Laboratory content was constructed using the Model of Educational Reconstruction and developed to enhance students ability to predicted the experiment results and analyzed the cause of error, calculating the accuracy and precision with carefully in using chemicals. This research showed students changing in making a decision and extremely beware with accuracy, but still had a low concern in precision. It enhancing students level of reflective thinking skill related to their prediction skill 1 until 2 stage in average. Most of them could predict the characteristics of the product in experiment, and even the result will going to be an error. In addition, they take experiments more seriously and curiously about the experiment results. This study recommends for a different subject matter to provide more opportunities for students to learn about other kinds of chemistry experiments design.

Keywords: virtual chemistry laboratory, chemistry experiments, prediction skill, pre-lab experiences

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Authors: Jacqueline M. Dias, Amina A Khowaja

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Clinical education is one of the most important components of a nursing curriculum as it develops the students’ cognitive, psychomotor and affective skills. Clinical teaching ensures the integration of knowledge into practice. As the numbers of students increase in the field of nursing coupled with the faculty shortage, clinical preceptors are the best choice to ensure student learning in the clinical settings. The clinical preceptor role has been introduced in the undergraduate nursing programme. In Pakistan, this role emerged due to a faculty shortage. Initially, two clinical preceptors were hired. This study will explore clinical preceptors views and experiences of precepting Bachelor of Science in Nursing (BScN) students in an undergraduate program. A case study design was used. As case studies explore a single unit of study such as a person or very small number of subjects; the two clinical preceptors were fundamental to the study and served as a single case. Qualitative data were obtained through an iterative process using in depth interviews and written accounts from reflective journals that were kept by the clinical preceptors. The findings revealed that the clinical preceptors were dedicated to their roles and responsibilities. Another, key finding was that clinical preceptors’ prior knowledge and clinical experience were valuable assets to perform their role effectively. The clinical preceptors found their new role innovative and challenging; it was stressful at the same time. Findings also revealed that in the clinical agencies there were unclear expectations and role ambiguity. Furthermore, clinical preceptors had difficulty integrating theory into practice in the clinical area and they had difficulty in giving feedback to the students. Although this study is localized to one university, generalizations can be drawn from the results. The key findings indicate that the role of a clinical preceptor is demanding and stressful. Clinical preceptors need preparation prior to precepting students on clinicals. Also, institutional support is fundamental for their acceptance. This paper focuses on the views and experiences of clinical preceptors undertaking a newly established role and resonates with the literature. The following recommendations are drawn to strengthen the role of the clinical preceptors: A structured program for clinical preceptors is needed along with mentorship. Clinical preceptors should be provided with formal training in teaching and learning with emphasis on clinical teaching and giving feedback to students. Additionally, for improving integration of theory into practice, clinical modules should be provided ahead of the clinical. In spite of all the challenges, ten more clinical preceptors have been hired as the faculty shortage continues to persist.

Keywords: baccalaureate nursing education, clinical education, clinical preceptors, nursing curriculum

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Authors: Recep Kesli, Cengiz Demir, Onur Turkyilmaz, Hayriye Tokay

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Objective: Gram-negative rods are a large group of bacteria, and include many families, genera, and species. Most clinical isolates belong to the family Enterobacteriaceae. Resistance due to the production of extended-spectrum β-lactamases (ESBLs) is a difficulty in the handling of Enterobacteriaceae infections, but other mechanisms of resistance are also emerging, leading to multidrug resistance and threatening to create panresistant species. We aimed in this study to evaluate resistance rates of Gram-negative rods bacteria isolated from clinical specimens in Microbiology Laboratory, Afyon Kocatepe University, ANS Research and Practice Hospital, between October 2012 and September 2015. Methods: The Gram-negative rods strains were identified by conventional methods and VITEK 2 automated identification system (bio-Mérieux, Marcy l’etoile, France). Antibiotic resistance tests were performed by both the Kirby-Bauer disk-diffusion and automated Antimicrobial Susceptibility Testing (AST, bio-Mérieux, Marcy l’etoile, France) methods. Disk diffusion results were evaluated according to the standards of Clinical and Laboratory Standards Institute (CLSI). Results: Of the totally isolated 1.701 Enterobacteriaceae strains 1434 (84,3%) were Klebsiella pneumoniae, 171 (10%) were Enterobacter spp., 96 (5.6%) were Proteus spp., and 639 Nonfermenting gram negatives, 477 (74.6%) were identified as Pseudomonas aeruginosa, 135 (21.1%) were Acinetobacter baumannii and 27 (4.3%) were Stenotrophomonas maltophilia. The ESBL positivity rate of the totally studied Enterobacteriaceae group were 30.4%. Antibiotic resistance rates for Klebsiella pneumoniae were as follows: amikacin 30.4%, gentamicin 40.1%, ampicillin-sulbactam 64.5%, cefepime 56.7%, cefoxitin 35.3%, ceftazidime 66.8%, ciprofloxacin 65.2%, ertapenem 22.8%, imipenem 20.5%, meropenem 20.5 %, and trimethoprim-sulfamethoxazole 50.1%, and for 114 Enterobacter spp were detected as; amikacin 26.3%, gentamicin 31.5%, cefepime 26.3%, ceftazidime 61.4%, ciprofloxacin 8.7%, ertapenem 8.7%, imipenem 12.2%, meropenem 12.2%, and trimethoprim-sulfamethoxazole 19.2 %. Resistance rates for Proteus spp. were: 24,3% meropenem, 26.2% imipenem, 20.2% amikacin 10.5% cefepim, 33.3% ciprofloxacin and levofloxacine, 31.6% ceftazidime, 20% ceftriaxone, 15.2% gentamicin, 26.6% amoxicillin-clavulanate, and 26.2% trimethoprim-sulfamethoxale. Resistance rates of P. aeruginosa was found as follows: Amikacin 32%, gentamicin 42 %, imipenem 43%, merpenem 43%, ciprofloxacin 50%, levofloxacin 52%, cefepim 38%, ceftazidim 63%, piperacillin/tacobactam 85%, for Acinetobacter baumannii; Amikacin 53.3%, gentamicin 56.6 %, imipenem 83%, merpenem 86%, ciprofloxacin 100%, ceftazidim 100%, piperacillin/tacobactam 85 %, colisitn 0 %, and for S. malthophilia; levofloxacin 66.6 % and trimethoprim/sulfamethoxozole 0 %. Conclusions: This study showed that resistance in Gram-negative rods was a serious clinical problem in our hospital and suggested the need to perform typification of the isolated bacteria with susceptibility testing regularly in the routine laboratory procedures. This application guided to empirical antibiotic treatment choices truly, as a consequence of the reality that each hospital shows different resistance profiles.

Keywords: antibiotic resistance, gram negative rods, ESBL, VITEK 2

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Authors: Ali Ghorbanipour

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The aim of this study is to investigate the drug resistance pattern and the value of the MIC (minimum inhibitory concentration)method to reduce the impact of infectious diseases and the slow development of resistance. Method: The study was conducted on clinical specimens collected between 2018 to 2021. identification of isolates and antibiotic susceptibility testing were performed using conventional biochemical tests. Antibiotic resistance was determined using kibry-Bauer disk diffusion and MIC by E-test methods comparative with microdilution plate elisa method. Results were interpreted according to CLSI. Results: Out of 249600 different clinical specimens, 18720 different pathogenic bacteria by overall detection ratio 7.7% were detected. Among pathogen bacterial were Gram negative bacteria (70%,n=13000) and Gram positive bacteria(30%,n=5720).Medically relevant gram-negative bacteria include a multitude of species such as E.coli , Klebsiella .spp , Pseudomonas .aeroginosa , Acinetobacter .spp , Enterobacterspp ,and gram positive bacteria Staphylococcus.spp , Enterococcus .spp , Streptococcus .spp was isolated . Conclusion: Our results highlighted that the resistance ratio among Gram Negative bacteria and Gram positive bacteria with different infection is high it suggest constant screening and follow-up programs for the detection of antibiotic resistance and the value of MIC drug susceptibility reporting that provide a new way to the usage of resistant antibiotic in combination with other antibiotics or accurate weight of antibiotics that inhibit or kill bacteria. Evaluation of wrong medication in the expansion of resistance and side effects of over usage antibiotics are goals. Ali ghorbanipour presently working as a supervision at the microbiology department of Massoud medical laboratory. Iran. Earlier, he worked as head department of pulmonary infection in firoozgarhospital, Iran. He received master degree in 2012 from Fergusson College. His research prime objective is a biologic wound dressing .to his credit, he has Published10 articles in various international congresses by presenting posters.

Keywords: antimicrobial profile, MIC & MBC Method, microplate antimicrobial assay, E-test

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Authors: Jacob Nortey

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Introduction: In recent years, there has been an enormous success in discoveries of scientific knowledge in medicine coupled with the advancement of technology. Despite all these successes, diagnoses and treatment of diseases have become complex. According to the Ibero – American Study of Adverse Effects (IBEAS), about 10% of hospital patients suffer from secondary damage during the care process, and approximately 2% die from this process. Many clinical decision support systems have been developed to help mitigate some healthcare medical errors. Method: Relevant databases were searched, including ones that were peculiar to the clinical decision support system (that is, using google scholar, Pub Med and general google searches). The articles were then screened for a comprehensive overview of the functionality, consultative style and statistical usage of Dxplain Clinical decision support systems. Results: Inferences drawn from the articles showed high usage of Dxplain clinical decision support system for problem-based learning among students in developed countries as against little or no usage among students in Low – and Middle – income Countries. The results also indicated high usage among general practitioners. Conclusion: Despite the challenges Dxplain presents, the benefits of its usage to clinicians and students are enormous.

Keywords: dxplain, clinical decision support sytem, diagnosis, support systems

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Authors: O. Giorgishvili

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For calculation of foundations one of the important characteristics is the module of deformation (E0). As we all know, the main goal of calculation of the foundations of buildings on deformation is to arrange the base settling and difference in settlings in such limits that do not cause origination of cracks and changes in design levels that will be dangerous to standard operation in the buildings and their individual structures. As is known from the literature and the practical application, the modulus of deformation is determined by two basic methods: laboratory method, soil test on compression (without the side widening) and soil test in field conditions. As we know, the deformation modulus of soil determined by field method is closer to the actual modulus deformation of soil, but the complexity of the tests to be carried out and the financial concerns did not allow determination of ground deformation modulus by field method. Therefore, we determine the ground modulus of deformation by compression method without side widening. Concerning this, we introduce a new way for determination of ground modulus of deformation by laboratory order that occurs by side widening and more accurately reflects the ground modulus of deformation and more accurately reflects the actual modulus of deformation and closer to the modulus of deformation determined by the field method. In this regard, we bring a new approach on the ground deformation detection laboratory module, which is done by widening sides. The tests and the results showed that the proposed method of ground deformation modulus is closer to the results that are obtained in the field, which reflects the foundation's work in real terms more accurately than the compression of the ground deformation module.

Keywords: build, deformation modulus, foundations, ground, laboratory research

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Authors: Moon Jung Kim, Guil Rhim

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The clinical sensitivity of the “VEUPLEXTM TBI assay”, a clinical trial medical device, in mild traumatic brain injury was 28.6% (95% CI, 19.7%-37.5%), and the clinical specificity was 94.0% (95% CI, 89.3%). -98.7%). In addition, when the results analyzed by marker were put together, the sensitivity was higher when interpreting the two tests together than the two tests, UCHL1 and GFAP alone. Additionally, when sensitivity and specificity were analyzed based on CT results for the mild traumatic brain injury patient group, the clinical sensitivity for 2 CT-positive cases was 50.0% (95% CI: 1.3%-98.7%), and 19 CT-negative cases. The clinical specificity for cases was 68.4% (95% CI: 43.5% - 87.4%). Since the low clinical sensitivity for the two CT-positive cases was not statistically significant due to the small number of samples analyzed, it was judged necessary to secure and analyze more samples in the future. Regarding the clinical specificity analysis results for 19 CT-negative cases, there were a large number of patients who were actually clinically diagnosed with mild traumatic brain injury but actually received a CT-negative result, and about 31.6% of them showed abnormal results on VEUPLEXTM TBI assay. Although traumatic brain injury could not be detected in 31.6% of the CT scans, the possibility of actually suffering a mild brain injury could not be ruled out, so it was judged that this could be confirmed through follow-up observation of the patient. In addition, among patients with mild traumatic brain injury, CT examinations were not performed in many cases because the symptoms were very mild, but among these patients, about 25% or more showed abnormal results in the VEUPLEXTM TBI assay. In fact, no damage is observed with the naked eye immediately after traumatic brain injury, and traumatic brain injury is not observed even on CT. But in some cases, brain hemorrhage may occur (delayed cerebral hemorrhage) after a certain period of time, so the patients who did show abnormal results on VEUPLEXTM TBI assay should be followed up for the delayed cerebral hemorrhage. In conclusion, it was judged that it was difficult to judge mild traumatic brain injury with the VEUPLEXTM TBI assay only through clinical findings without CT results, that is, based on the GCS value. Even in the case of CT, it does not detect all mild traumatic brain injury, so it is difficult to necessarily judge that there is no traumatic brain injury, even if there is no evidence of traumatic brain injury in CT. And in the long term, more patients should be included to evaluate the usefulness of the VEUPLEXTM TBI assay in the detection of microscopic traumatic brain injuries without using CT.

Keywords: brain injury, traumatic brain injury, GFAP, UCHL1

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Authors: Rozi Laskaraki, Argyris Karapetsas, Aikaterini Karapetsa

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This paper is focused on the efficacy of a rehabilitation program based on musical activities, implied to a group of school-aged dyslexic children. Objective: The purpose of this study was to investigate the efficacy of auditory training including musical exercises in children with developmental dyslexia (DD). Participants and Methods: 45 third-, and fourth-grade students with DD and a matched control group (n=45) were involved in this study. In the beginning, students participated in a clinical assessment, including both electrophysiological (i.e., event related potentials (ERPs) esp.P300 waveform) and neuropsychological tests, being conducted in Laboratory of Neuropsychology, at University of Thessaly, in Volos, Greece. Initial assessment’s results confirmed statistically significant lower performance for children with DD, compared to that of the typical readers. After clinical assessment, a subgroup of children with dyslexia was submitted to a music auditory training program, conducted in 45-minute training sessions, once a week, for twenty weeks. The program included structured and digitized musical activities involving pitch, rhythm, melody and tempo perception and discrimination as well as auditory sequencing. After the intervention period, children underwent a new recording of ERPs. Results: The electrophysiological results revealed that children had similar P300 latency values to that of the controls, after the remediation program; thus children overcame their deficits. Conclusion: The outcomes of the current study suggest that ERPs is a valid clinical tool in neuropsychological assessment settings and dyslexia can be ameliorated through music auditory training.

Keywords: dyslexia, event related potentials, learning disabilities, music, rehabilitation

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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: 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: Farzana Esmailkassam, Usakorn Kunanuvat, Zahraa Mohammed Ali

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Objective: The key barrier in Clozapine treatment of treatment-resistant schizophrenia (TRS) includes frequent bloods draws to monitor neutropenia, the main drug side effect. WBC and ANC monitoring must occur throughout treatment. Accurate WBC and ANC counts are necessary for clinical decisions to halt, modify or continue clozapine treatment. The CSAN Pronto point-of-care (POC) analyzer generates white blood cells (WBC) and absolute neutrophils (ANC) through image analysis of capillary blood. POC monitoring offers significant advantages over central laboratory testing. This study evaluated the performance of the CSAN Pronto against the Beckman DxH900 Hematology laboratory analyzer. Methods: Forty venous samples (EDTA whole blood) with varying concentrations of WBC and ANC as established on the DxH900 analyzer were tested in duplicates on three CSAN Pronto analyzers. Additionally, both venous and capillary samples were concomitantly collected from 20 volunteers and assessed on the CSAN Pronto and the DxH900 analyzer. The analytical performance including precision using liquid quality controls (QCs) as well as patient samples near the medical decision points, and linearity using a mix of high and low patient samples to create five concentrations was also evaluated. Results: In the precision study for QCs and whole blood, WBC and ANC showed CV inside the limits established according to manufacturer and laboratory acceptability standards. WBC and ANC were found to be linear across the measurement range with a correlation of 0.99. WBC and ANC from all analyzers correlated well in venous samples on the DxH900 across the tested sample ranges with a correlation of > 0.95. Mean bias in ANC obtained on the CSAN pronto versus the DxH900 was 0.07× 109 cells/L (95% L.O.A -0.25 to 0.49) for concentrations <4.0 × 109 cells/L, which includes decision-making cut-offs for continuing clozapine treatment. Mean bias in WBC obtained on the CSAN pronto versus the DxH900 was 0.34× 109 cells/L (95% L.O.A -0.13 to 0.72) for concentrations <5.0 × 109 cells/L. The mean bias was higher (-11% for ANC, 5% for WBC) at higher concentrations. The correlations between capillary and venous samples showed more variability with mean bias of 0.20 × 109 cells/L for the ANC. Conclusions: The CSAN pronto showed acceptable performance in WBC and ANC measurements from venous and capillary samples and was approved for clinical use. This testing will facilitate treatment decisions and improve clozapine uptake and compliance.

Keywords: absolute neutrophil counts, clozapine, point of care, white blood cells

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