Search results for: clinical data warehouse

Authors: Rajesh Kumar G

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A challenging aspect of any clinical trial is to carefully plan the study design to meet the study objective in optimum way and to validate the assumptions made during protocol designing. And when it is a pediatric study, there is the added challenge of stringent guidelines and difficulty in recruiting the necessary subjects. Unlike adult trials, there is not much historical data available for pediatrics, which is required to validate assumptions for planning pediatric trials. Typically, pediatric studies are initiated as soon as approval is obtained for a drug to be marketed for adults, so with the adult study historical information and with the available pediatric pilot study data or simulated pediatric data, the pediatric study can be well planned. Generalizing the historical adult study for new pediatric study is a tedious task; however, it is possible by integrating various statistical techniques and utilizing the advantage of hybrid study design, which will help to achieve the study objective in a smoother way even with the presence of many constraints. This research paper will explain how well the hybrid study design can be planned along with integrated technique (SEV) to plan the pediatric study; In brief the SEV technique (Simulation, Estimation (using borrowed adult data and applying Bayesian methods)) incorporates the use of simulating the planned study data and getting the desired estimates to Validate the assumptions.This method of validation can be used to improve the accuracy of data analysis, ensuring that results are as valid and reliable as possible, which allow us to make informed decisions well ahead of study initiation. With professional precision, this technique based on the collected data allows to gain insight into best practices when using data from historical study and simulated data alike.

Keywords: adaptive design, simulation, borrowing data, bayesian model

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Authors: Dmitry Yu. Korulkin, Raissa A. Muzychkina, Evgenii N. Kojaev

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In review the generalized data about biological activity of anthraquinone-containing plants and specimens on their basis is presented. Data of traditional medicine, results of bioscreening and clinical researches of specimens are analyzed.

Keywords: anthraquinones, physiologically active substances, phytopreparation, Ramon

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Authors: Wafaa M. El- Kotb, Soheir Mohamed Weheida, Manal E. Fareed

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The aim of this study was to determine the effect of implementing a teaching module about diet and exercises on clinical outcomes of patients with gout. Subjects: A purposive sample of 60 adult gouty patients was selected and randomly and alternatively divided into two equal groups 30 patients in each. Setting: The study was conducted in orthopedic out patient's clinic of Menoufia University. Tools of the study: Three tools were utilized for data collection: Knowledge assessment structured interview questionnaire, Clinical manifestation assessment tools and Nutritional assessment sheet. Results: All patients of both groups (100 %) had poor total knowledge score pre teaching, while 90 % of the study group had good total knowledge score post teaching by three months compared to 3.3 % of the control group. Moreover the recovery outcomes were significantly improved among study group compared to control group post teaching. Conclusion: Teaching study group about diet and exercises significantly improved their clinical outcomes. Recommendation: Patient's education about diet and exercises should be ongoing process for patients with gout.

Keywords: clinical outcomes, diet, exercises, teaching module

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Authors: Traci A. Hefner

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Limited research exists on the readiness of emergency departments to respond to human trafficking (HT). The purpose of this qualitative case study was to improve the readiness of a Department of Emergency Medicine (ED), located in the southeast region of the United States, in identifying, assessing, and responding to trafficked individuals. The research objectives were to 1) provide an organizing framework to understand the ED’s readiness to respond to HT, using the Transtheoretical Model’s stages of change construct, 2) explain the readiness of the ED through a three-pronged contextual approach that included policies and procedures, patient data collection processes, and clinical practice methods, and 3) develop recommendations to respond to HT. Content analysis was used for document reviews and on-site observations, while thematic analysis identified themes of staff perceptions of the ED’s readiness in interviews of over 30 clinical and non-clinical healthcare professionals. Results demonstrated low levels of readiness to identify HT through the ED’s policies and procedures, data collection processes, and clinical practice methods. Clinical practice-related factors consisted of limited awareness of HT warning signs and low-levels of knowledge about community resources for possible HT referrals. Policy and practice recommendations to increase the ED’s readiness to respond to HT included: developing staff trainings across the ED system to enhance awareness of HT warning signs, incorporating HT into current policies and procedures for vulnerable patient populations as well as creating a HT protocol that addresses policies and procedures, screening tools, and community referrals.

Keywords: emergency medicine, human trafficking, organizational assessment, stages of change

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Authors: Jirarat Teeravaraprug, Usawadee Inklay

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This paper gave an attempt in prioritizing information technologies that organizations should give concentration. The case study was organizations in the automotive assembly industry in Thailand. Data were first collected to gather all information technologies known and used in the automotive assembly industry in Thailand. Five experts from the industries were surveyed based on the concept of fuzzy DEMATEL. The information technologies were categorized into six groups, which were communication, transaction, planning, organization management, warehouse management, and transportation. The cause groups of information technologies for each group were analysed and presented. Moreover, the relationship between the used and the significant information technologies was given. Discussions based on the used information technologies and the research results are given.

Keywords: information technology, automotive assembly industry, fuzzy DEMATEL

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Authors: Lu-Chiu Huang, Pei-Pei Chen, Li-Chin Yu, Chiao-Wen Kuo, Tsui-Tao Liu, Rung-Chuang Feng

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Purpose: People put increasing emphasis on demands of medical quality and protecting their interests. Patients' or family's dissatisfaction with medical care may easily lead to medical dispute. Physician-family communication plays an essential role in medical care. A sound communication cannot only strengthen patients' belief in the medical team but make patient have definite insight into treatment course of the disease. A family meeting provides an effective platform for communication between clinical staff, patients and family. Decisions and consensuses formed in family meetings can promote patients' or family's satisfaction with medical care. Clinical staff's attitudes toward family meeting may determine behavioral intentions to hold family meeting. This study aims to explore clinical staff's difficulties in holding family meeting and evaluate how their attitudes and behavior influence the effect of family meetings. Methods: This was a cross-sectional study. It was conducted at a regional teaching hospital in Taipei city. The research team developed its own structural questionnaires, whose expert validity was checked by the nursing experts. Participants filled in the questionnaires online. Data were collected by convenience sampling. A total of 568 participants were invited. They included doctors, nurses, social workers, and so on. Results: 1) The average score of ‘clinical staff’s attitudes to family meetings’ was 5.15 (SD=0.898). It fell between ‘somewhat agree’ and ‘mostly agree’ on the 7-point likert scale. It indicated that clinical staff had positive attitudes toward family meetings, 2) The average score of ‘clinical staff’s behavior to family meetings’ was 5.61 (SD=0.937). It fell between ‘somewhat agree’ and ‘mostly agree’ on the 7-point likert scale. It meant clinical staff tended to have positive behavior at the family meeting, and 3) The average score of ‘Difficulty in conducting family meetings’ was 5.15 (SD=0.897). It fell between ‘somewhat agree’ and ‘mostly agree’ on the 7-point likert scale. The higher the score was, the less difficulty the clinical staff felt. It demonstrated clinical staff felt less difficulty in conducting family meetings. Clinical staff's identification with family meetings brought favored effects. Persistent and active promotion for family meetings can bring patients and family more benefits. Implications for practice: Understanding clinical staff's difficulty in participating family meeting and exploring their attitudes or behavior toward physician-family communication are helpful to develop modes of interaction. Consequently, quality and satisfaction of physician-family communication can be increased.

Keywords: clinical staff, communication, family meeting, physician-family

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Authors: Adel Nikfarjam, Hamed Tayebi, Sadoullah Ebrahimnejad

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This paper considers a two-echelon inventory system with a number of warehouses and a single retailer. The retailer replenishes its required items from warehouses, and assembles them into a single final product. We assume that each warehouse supplies only one kind of the raw material for the retailer. The demand process of the final product is assumed to be Poissson, and unsatisfied demand of the final product will be lost. The retailer applies one-for-one-period ordering policy which is also known as (1, T) ordering policy. In this policy the retailer orders to each warehouse a fixed quantity of each item at fixed time intervals, which the fixed quantity is equal to the utilization of the item in the final product. Since, this policy eliminates all demand uncertainties at the upstream echelon, the standard lot sizing model can be applied at all warehouses. In this paper, we calculate the total cost function of the inventory system. Then, based on this function, we present a procedure to obtain the optimal time interval between two consecutive order placements from retailer to the warehouses, and the optimal order quantities of warehouses (assuming that there are positive ordering costs at warehouses). Finally, we present some numerical examples, and conduct numerical sensitivity analysis for cost parameters.

Keywords: two-echelon supply chain, multi-vendor-single-buyer inventory system, lost sales, Poisson demand, one-for-one-period policy, lot sizing model

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Authors: Muhammad Umair, Yuri Nikolaev, Denis Artemov, Ighor Uzhinsky

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A flexible manufacturing system is an integral part of a smart factory of industry 4.0 in which every machine is interconnected and works autonomously. Robots are in the process of replacing humans in every industrial sector. As the cyber-physical-system (CPS) and artificial intelligence (AI) are advancing, the manufacturing industry is getting more dependent on computers than human brains. This modernization has boosted the production with high quality and accuracy and shifted from classic production to smart manufacturing systems. However, material handling for such automated productions is a challenge and needs to be addressed with the best possible solution. Conventional clamping systems are designed for manual work and not suitable for highly automated production systems. Researchers and engineers are trying to find the most economical solution for loading/unloading and transportation workpieces from a warehouse to a machine shop for machining operations and back to the warehouse without human involvement. This work aims to propose an advanced multi-shape tooling solution for highly automated manufacturing systems. The currently obtained result shows that it could function well with automated guided vehicles (AGVs) and modern conveyor belts. The proposed solution is following requirements to be automation-friendly, universal for different part geometry and production operations. We used a bottom-up approach in this work, starting with studying different case scenarios and their limitations and finishing with the general solution.

Keywords: artificial intelligence, cyber physics system, Industry 4.0, material handling, smart factory, flexible manufacturing system

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Authors: Shohreh Ghasemi

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Introduction: Melanoma is a complex disease with various clinical and histopathological features that impact prognosis and treatment decisions. Traditional methods of melanoma prognosis involve manual examination and interpretation of clinical and histopathological data by dermatologists and pathologists. However, the subjective nature of these assessments can lead to inter-observer variability and suboptimal prognostic accuracy. AI, with its ability to analyze vast amounts of data and identify patterns, has emerged as a promising tool for improving melanoma prognosis. Methods: A comprehensive literature search was conducted to identify studies that employed AI techniques for melanoma prognosis. The search included databases such as PubMed and Google Scholar, using keywords such as "artificial intelligence," "melanoma," and "prognosis." Studies published between 2010 and 2022 were considered. The selected articles were critically reviewed, and relevant information was extracted. Results: The review identified various AI methodologies utilized in melanoma prognosis, including machine learning algorithms, deep learning techniques, and computer vision. These techniques have been applied to diverse data sources, such as clinical images, dermoscopy images, histopathological slides, and genetic data. Studies have demonstrated the potential of AI in accurately predicting melanoma prognosis, including survival outcomes, recurrence risk, and response to therapy. AI-based prognostic models have shown comparable or even superior performance compared to traditional methods.

Keywords: artificial intelligence, melanoma, accuracy, prognosis prediction, image analysis, personalized medicine

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Authors: Alejandro Rodríguez-Molinero, Carlos Pérez-López, Jorge Hernández-Vara, Àngels Bayes-Rusiñol, Juan Carlos Martínez-Castrillo, David A. Pérez-Martínez

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Background: Monitoring motor symptoms in Parkinson's patients is often a complex and time-consuming task for clinicians, as Hauser's diaries are often poorly completed by patients. Recently, new automatic devices (Parkinson's holter: STAT-ON®) have been developed capable of monitoring patients' motor fluctuations. The MoMoPa-EC clinical trial (NCT04176302) investigates which of the two methods produces better clinical results. In this sub-analysis, the concordance between both methods is analyzed. Methods: In the MoMoPa-EC clinical trial, 164 patients with moderate-severe Parkinson's disease and at least two hours a day of Off will be included. At the time of patient recruitment, all of them completed a seven-day motor fluctuation diary at home (Hauser’s diary) while wearing the Parkinson's holter. In this sub-analysis, 71 patients with complete data for the purpose of this comparison were included. The intraclass correlation coefficient was calculated between the patient diary entries and the Parkinson's holter data in terms of time On, Off, and time with dyskinesias. Results: The intra-class correlation coefficient of both methods was 0.57 (95% CI: 0.3-0.74) for daily time in Off (%), 0.48 (95% CI: 0.14-0.68) for daily time in On (%), and 0.37 (95% CI %: -0.04-0.62) for daily time with dyskinesias (%). Conclusions: Both methods have a moderate agreement with each other. We will have to wait for the results of the MoMoPa-EC project to estimate which of them has the greatest clinical benefits. Acknowledgment: This work is supported by AbbVie S.L.U, the Instituto de Salud Carlos III [DTS17/00195], and the European Fund for Regional Development, 'A way to make Europe'.

Keywords: Parkinson, sensor, motor fluctuations, dyskinesia

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Authors: Mohamed Wahba

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Objective: To build a comparative arm for product (X) in specific gene mutated advanced gastrointestinal cancer using real world evidence to fulfill HTA requirements in drug evaluation. Methods: Data for product (X) were collected from phase II clinical trial while real world data for (Y) and (Z) were collected from US database. Real-world (RW) cohorts were matched to clinical trial base line characteristics using weighting by odds method. Outcomes included progression-free survival (PFS) and overall survival (OS) rates. Study location and participants: Internationally (product X, n=80) and from USA (Product Y and Z, n=73) Results: Two comparisons were made: trial cohort 1 (X) versus real-world cohort 1 (Z), trial cohort 2 (X) versus real-world cohort 2 (Y). For first line, the median OS was 9.7 months (95% CI 8.6- 11.5) and the median PFS was 5.2 months (95% CI 4.7- not reached) for real-world cohort 1. For second line, the median OS was 10.6 months (95% CI 4.7- 27.3) for real-world cohort 2 and the median PFS was 5.0 months (95% CI 2.1- 29.3). For OS analysis, results were statistically significant but not for PFS analysis. Conclusion: This study provided the clinical comparative outcomes needed for HTA evaluation.

Keywords: real world evidence, pharmacoeconomics, HTA agencies, oncology

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Authors: Joanne M. Emmens

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This paper makes use of the case notes of a single psychoanalytically informed psychotherapy of a now 72-year-old man over a four-year period to explore the potential of qualitative data to be incorporated into a research methodology that can contribute theory and knowledge to the wider professional community involved in mental health care. The clinical material arising out of any psychoanalysis provides a potentially rich source of clinical data that could contribute valuably to our historical understanding of both individual and societal traumata. As psychoanalysis is primarily an investigation, it is argued that clinical case material is a rich source of qualitative data which has relevance for sociological and historical understandings and that it can potentially aluminate important ‘gaps’ and collective blind spots that manifest unconsciously and are a contributing factor in the transmission of trauma, silently across generations. By attending to this case material the hope is to illustrate the value of using a psychoanalytic centred methodology. It is argued that the study of individual defences and the manner in which they come into consciousness, allows an insight into group defences and the unconscious forces that contribute to the silencing or un-noticing of important sources (or originators) of mental suffering.

Keywords: dream furniture (Bion) and psychotic functioning, reverie, screen memories, selected fact

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Authors: Sheeraz Memon, Namunu C. Maddage, Margaret Lech, Nicholas Allen

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The effect of a clinical environment on the accuracy of the speaker verification was tested. The speaker verification tests were performed within homogeneous environments containing clinically depressed speakers only, and non-depresses speakers only, as well as within mixed environments containing different mixtures of both climatically depressed and non-depressed speakers. The speaker verification framework included the MFCCs features and the GMM modeling and classification method. The speaker verification experiments within homogeneous environments showed 5.1% increase of the EER within the clinically depressed environment when compared to the non-depressed environment. It indicated that the clinical depression increases the intra-speaker variability and makes the speaker verification task more challenging. Experiments with mixed environments indicated that the increase of the percentage of the depressed individuals within a mixed environment increases the speaker verification equal error rates.

Keywords: speaker verification, GMM, EM, clinical environment, clinical depression

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Authors: Luca Martignoni

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The increasing usage of clinical decision support systems in healthcare and the demand for software that enables doctors to take informed decisions is changing everyday clinical practice. However, as technology advances not only are the benefits of technology growing, but so are the potential risks. A growing danger is the doctors’ over-reliance on the proposed decision of the clinical decision support system, leading towards deskilling and rash decisions by doctors. In that regard, identifying doctors' requirements for software and developing approaches to prevent technological over-reliance is of utmost importance. In this paper, we report the results of a design science research study, focusing on the requirements and design principles of ultrasound software. We conducted a total of 15 interviews with experts about poten-tial ultrasound software functions. Subsequently, we developed meta-requirements and design principles to design future clinical decision support systems efficiently and as free from the occur-rence of technological over-reliance as possible.

Keywords: clinical decision support systems, technological over-reliance, design principles, design science research

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Authors: Issa M. Shehabat, Huda F. Y. Nimri

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This paper aims to study the relationship between knowledge management in its processes, including knowledge creation, knowledge sharing, knowledge organization, and knowledge application, and business intelligence tools, including OLAP, data mining, and data warehouse, and their impact on the decision-making process in the banking sector in Jordan. A total of 200 questionnaires were distributed to the sample of the study. The study hypotheses were tested using the statistical package SPSS. Study findings suggest that decision-making processes were positively related to knowledge management processes. Additionally, the components of business intelligence had a positive impact on decision-making. The study recommended conducting studies similar to this study in other sectors such as the industrial, telecommunications, and service sectors to contribute to enhancing understanding of the role of the knowledge management processes and business intelligence tools.

Keywords: business intelligence, knowledge management, decision making, Jordan, banking sector

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Authors: Nisa Mohan

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Clinical coding is a feasible method for estimating the national prevalence of adverse drug event (ADE) admissions. However, under-coding of ADE admissions is a limitation of this method. Whilst the under-coding will impact the accurate estimation of the actual burden of ADEs, the feasibility of the coded data in estimating the adverse drug event admissions goes much further compared to the other methods. Therefore, it is necessary to know the reasons for the under-coding in order to improve the clinical coding of ADE admissions. The ability to identify the reasons for the under-coding of ADE admissions rests on understanding the decision-making process of coding ADE admissions. Hence, the current study aimed to explore the decision-making process of clinical coders when coding cases of ADE admissions. Clinical coders from different levels of coding job such as trainee, intermediate and advanced level coders were purposefully selected for the interviews. Thirteen clinical coders were recruited from two Auckland region District Health Board hospitals for the interview study. Semi-structured, one-on-one, face-to-face interviews using open-ended questions were conducted with the selected clinical coders. Interviews were about 20 to 30 minutes long and were audio-recorded with the approval of the participants. The interview data were analysed using a general inductive approach. The interviews with the clinical coders revealed that the coders have targets to meet, and they sometimes hesitate to adhere to the coding standards. Coders deviate from the standard coding processes to make a decision. Coders avoid contacting the doctors for clarifying small doubts such as ADEs and the name of the medications because of the delay in getting a reply from the doctors. They prefer to do some research themselves or take help from their seniors and colleagues for making a decision because they can avoid a long wait to get a reply from the doctors. Coders think of ADE as a small thing. Lack of time for searching for information to confirm an ADE admission, inadequate communication with clinicians, along with coders’ belief that an ADE is a small thing may contribute to the under-coding of the ADE admissions. These findings suggest that further work is needed on interventions to improve the clinical coding of ADE admissions. Providing education to coders about the importance of ADEs, educating clinicians about the importance of clear and confirmed medical records entries, availing pharmacists’ services to improve the detection and clear documentation of ADE admissions, and including a mandatory field in the discharge summary about external causes of diseases may be useful for improving the clinical coding of ADE admissions. The findings of the research will help the policymakers to make informed decisions about the improvements. This study urges the coding policymakers, auditors, and trainers to engage with the unconscious cognitive biases and short-cuts of the clinical coders. This country-specific research conducted in New Zealand may also benefit other countries by providing insight into the clinical coding of ADE admissions and will offer guidance about where to focus changes and improvement initiatives.

Keywords: adverse drug events, clinical coders, decision making, hospital admissions

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Authors: Shuo Mu, Guangzhi Jiang, Jinsa Chen

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The analysis of Indel for RNA sequencing of clinical samples is easily affected by sequencing experiment errors and software selection. In order to improve the efficiency and accuracy of analysis, we developed an automatic reporting system for Indel recognition and annotation based on image snapshot of transcriptome reads alignment. This system includes sequence local-assembly and realignment, target point snapshot, and image-based recognition processes. We integrated high-confidence Indel dataset from several known databases as a training set to improve the accuracy of image processing and added a bioinformatical processing module to annotate and filter Indel artifacts. Subsequently, the system will automatically generate data, including data quality levels and images results report. Sanger sequencing verification of the reference Indel mutation of cell line NA12878 showed that the process can achieve 83% sensitivity and 96% specificity. Analysis of the collected clinical samples showed that the interpretation accuracy of the process was equivalent to that of manual inspection, and the processing efficiency showed a significant improvement. This work shows the feasibility of accurate Indel analysis of clinical next-generation sequencing (NGS) transcriptome. This result may be useful for RNA study for clinical samples with microsatellite instability in immunotherapy in the future.

Keywords: automatic reporting, indel, next-generation sequencing, NGS, transcriptome

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Authors: Pornthip Seangsanga

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Sepsis or septic shock needs urgent care because it is a cause of the high mortality rate if patients do not receive timely treatment. Songkhla Hospital does not have a clear system or clinical practice guidelines for treatment of patients with severe sepsis or septic shock, which contributes to the said problem.To compare clinical outcomes based on the protocol after using the clinical guidelines between the Emergency Room, Intensive Care Unit, and the Ward. This quasi-experimental study was conducted on the population and 50 subjects who were diagnosed with severe sepsis or septic shock from December 2013 to May 2014. The data were collected using a nursing care and referring record form for patients with severe sepsis or septic shock at Songkhla Hospital. The record form had been tested for its validity by three experts, and the IOC was 1.The mortality rate in patients with severe sepsis or septic shock who were moved from the ER to the ICU was significantly lower than that of those patients moved from the Ward to the ICU within 48 hours. This was because patients with severe sepsis or septic shock who were moved from the ER to the ICU received more fluid within the first six hours according to the protocol which helped patients to have adequate tissue perfusion within the first six hours, and that helped improve blood flow to the kidneys, and the patients’ urine was found to be with a higher quantity of 0.5 cc/kg/hr, than those patients who were moved from the Ward to the ICU. This study shows that patients with severe sepsis or septic shock need to be treated immediately. Using the clinical practice guidelines along with timely diagnosis and treatment based on the sepsis bundle in giving sufficient and suitable amount of fluid to help improve blood circulation and blood pressure can clearly prevent or reduce severity of complications.

Keywords: clinical practice guidelines, caring, septic shock, sepsis bundle protocol

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Authors: Watin Alkhelaiwi, Iseult Wilson, Marian Traynor, Katherine Rogers

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Clinical nursing education allows nursing students to gain essential knowledge from practice experience and develop nursing skills in a variety of clinical environments. Integrating theoretical knowledge and practical skills is made easier for nursing students by providing opportunities for practice in a clinical environment. Nursing competency is an essential capability required to fulfill nursing responsibilities. Effective mentoring in clinical settings helps nursing students develop the necessary competence and promotes the integration of theory and practice. Preceptors play a considerable role in clinical nursing education, including the supervision of nursing students undergoing a rigorous clinical practicum. Preceptors are also involved in the clinical assessment of nursing students’ competency. The assessment of nursing students’ competence by professional practitioners is essential to investigate whether nurses have developed an adequate level of competence to deliver safe nursing care. Competency assessment remains challenging among nursing educators and preceptors, particularly owing to the complexity of the process. Consistency in terms of assessment methods and tools and valid and reliable assessment tools for measuring competence in clinical practice are lacking. Nurse preceptors must assess students’ competencies to prepare them for future professional responsibilities. Preceptors encounter difficulties in the assessment of competency owing to the nature of the assessment process, lack of standardised assessment tools, and a demanding clinical environment. The purpose of the study is to examine nursing preceptors’ experiences of assessing nursing interns’ competency in Saudi Arabia. There are three objectives in this study; the first objective is to examine the preceptors’ view of the Saudi assessment tool in relation to preceptorship, assessment, the assessment tool, the nursing curriculum, and the grading system. The second and third objectives are to examine preceptors’ view of "competency'' in nursing and their interpretations of the concept of competency and to assess the implications of the research in relation to the Saudi 2030 vision. The study uses an exploratory sequential mixed-methods design that involves a two-phase project: a qualitative focus group study is conducted in phase 1, and a quantitative study- a descriptive cross-sectional design (online survey) is conducted in phase 2. The results will inform the preceptors’ view of the Saudi assessment tool in relation to specific areas, including preceptorship and how the preceptors are prepared to be assessors, and assessment and assessment tools through identifying the appropriateness of the instrument for clinical practice. The results will also inform the challenges and difficulties that face the preceptors. These results will be analysed thematically for the focus group interview data, and SPSS software will be used for the analysis of the online survey data.

Keywords: clinical assessment tools, clinical competence, competency assessment, mentor, nursing, nurses, preceptor

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Authors: Henry Lau, Dilupa Nakandala, Li Zhao

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All along the length of the supply chain, fresh food firms face the challenge of managing both product quality, due to the perishable nature of the products, and product cost. This paper develops a method to assist logistics managers upstream in the fresh food supply chain in making cost optimized decisions regarding transportation, with the objective of minimizing the total cost while maintaining the quality of food products above acceptable levels. Considering the case of multiple fresh food products collected from multiple farms being transported to a warehouse or a retailer, this study develops a total cost model that includes various costs incurred during transportation. The practical application of the model is illustrated by using several computational intelligence approaches including Genetic Algorithms (GA), Fuzzy Genetic Algorithms (FGA) as well as an improved Simulated Annealing (SA) procedure applied with a repair mechanism for efficiency benchmarking. We demonstrate the practical viability of these approaches by using a simulation study based on pertinent data and evaluate the simulation outcomes. The application of the proposed total cost model was demonstrated using three approaches of GA, FGA and SA with a repair mechanism. All three approaches are adoptable; however, based on the performance evaluation, it was evident that the FGA is more likely to produce a better performance than the other two approaches of GA and SA. This study provides a pragmatic approach for supporting logistics and supply chain practitioners in fresh food industry in making important decisions on the arrangements and procedures related to the transportation of multiple fresh food products to a warehouse from multiple farms in a cost-effective way without compromising product quality. This study extends the literature on cold supply chain management by investigating cost and quality optimization in a multi-product scenario from farms to a retailer and, minimizing cost by managing the quality above expected quality levels at delivery. The scalability of the proposed generic function enables the application to alternative situations in practice such as different storage environments and transportation conditions.

Keywords: cost optimization, food supply chain, fuzzy sets, genetic algorithms, product quality, transportation

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Authors: Itamir de Morais Barroca Filho, Cephas A. S. Barreto, Ramon Malaquias, Cezar Miranda Paula de Souza, Arthur Costa Gorgônio, João C. Xavier-Júnior, Mateus Firmino, Fellipe Matheus Costa Barbosa

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Information and Communication Technologies (ICT) in healthcare are crucial for efficiently delivering medical healthcare services to patients. These ICTs are also known as e-health and comprise technologies such as electronic record systems, telemedicine systems, and personalized devices for diagnosis. The focus of e-health is to improve the quality of health information, strengthen national health systems, and ensure accessible, high-quality health care for all. All the data gathered by these technologies make it possible to help clinical staff with automated decisions using machine learning. In this context, we collected patient data, such as heart rate, oxygen saturation (SpO2), blood pressure, respiration, and others. With this data, we were able to develop machine learning models for patients’ risk of death and estimate the length of stay in ICU beds. Thus, this paper presents the methodology for applying machine learning techniques to develop these models. As a result, although we implemented these models on an IoT healthcare platform, helping clinical staff in healthcare in an ICU, it is essential to create a robust clinical validation process and monitoring of the proposed models.

Keywords: ICT, e-health, machine learning, ICU, healthcare

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Authors: Inkyong Yi

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Acute kidney injury (AKI) in trauma patients is known to be associated with multiple factors, especially shock and consequent inadequate renal perfusion, yet its clinical presentation is little known in severe trauma patients. Our aim was to investigate the clinical presentation of acute kidney injury and its outcome in severe trauma patients at a level I trauma center. A total of 93 consecutive adult trauma patients with an injury severity score (ISS) of more than 15 were analyzed retrospectively from our Level I trauma center data base. Patients with direct renal injury were excluded. Patients were dichotomized into two groups, according to the presence of AKI. Various clinical parameters were compared between two groups, with Student’s T test and Mann-Whitney’s U test. The AKI group was further dichotomized into patients who recovered within seven days, and those who required more than 7days for recovery or those who did not recover at all. Various clinical parameters associated with outcome were further analyzed. Patients with AKI (n=33, 35%) presented with significantly higher age (61.4±17.3 vs. 45.4±17.3, p < 0.0001), incidence of comorbidities (hypertension; 51.5% vs. 13.3%, OR 6.906 95%CI 2.515-18.967, diabetes; 27.3% vs. 6.7%, OR 5.250, 95%CI 1.472-18.722), odds of head and neck trauma (69.7% vs. 41.7%, OR 3.220, 95%CI 1.306-7.942) and presence of shock during emergency room care (66.7% vs 21.7% OR 7.231, 95%CI, 2.798-18.687). Among AKI patients, patients who recovered within 1 week showed lower peak lactate (4.7mmol/L, 95%CI 2.9-6.5 vs 7.3mmol/L, 95%CI 5.0-9.6, p < 0.0287), lesser units of transfusion during first 24 hours (pRBC; 20.4unit, 95%CI 12.5-28.3 vs. 58.9unit, 95%CI 39.4-78.5, p=0.0003, FFP; 16.6unit, 95%CI 6.8-26.4 vs. 56.1unit, 95%CI 26.9-85.2, p=0.0027). In severe trauma patients, patients with AKI showed different clinical presentations and worse outcomes. Initial presence of shock and higher DIC profiles may be important risk factors for AKI in severe trauma patients. In patients with AKI, peak lactate level and amounts of transfusion are related to recovery.

Keywords: acute kidney injury, lactate, transfusion, trauma

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Authors: Tuong Thi Van Thuy, Dao Van Toan, Nguyen Duc Phuc

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Mesenchymal stem cells (MSCs) were discovered in the 1970s with their unique properties of differentiation, immunomodulation, multiple secreting, and homing factors to injured organs. MSC-based therapies have emerged as a promising strategy for various diseases such as cancer, tissue regeneration, or immunologic/inflammatory-related diseases. This study evaluated the clinical application of MSCs for cancer therapy in trials registered on Clinical Trial as of July 2022. The results showed 40 clinical trials used MSCs in various cancer conditions. 62% of trials used MSCs for therapeutic purposes to minimize the side effects of cancer treatment. Besides, 38% of trials were focused on using MSCs as a therapeutic agent to treat cancer directly. Most trials (38/40) are ongoing phase I/II, and 2 are entering phase III. 84% of trials used allogeneic MSCs compared with 13% using autologous sources and 3% using both. 25/40 trials showed participants received a single dose of MSCs, while the most times were 12 times in a pancreatic cancer treatment trial. Conclusion: MSC-based therapy for cancer in clinical trials should be applied to (1) minimize the side effects of oncological treatments and (2) directly affect the tumor via selectively delivering anti-cancer payloads to tumor cells. Allogeneic MSCs are a priority selected in clinical cancer therapy.

Keywords: mesenchymal stem cells, MSC-based therapy, cancer condition, cancer treatment, clinical trials

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Authors: Ilham Akbar Rahman, Aflah Dhea Bariz Yasta, Iin Fadhilah Utami Tamasse, Devina Juanita

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Meningioma is adult brain tumors originating from the meninges covering the brain and spinal cord. The females have approximately twice higher 2:1 than male in the incidence of meningioma. This study aimed to analyze the histopathological grading and clinical aspect in predicting the prognosis of meningioma patients. An observational study with cross sectional design was used on 53 meningioma patients treated at Dr. Wahidin Sudirohusodo hospital in 2016. The data then were analyzed using SPSS 20.0. Of 53 patients, mostly 41 (77,4%) were female and 12 (22,6%) were male. The distribution of histopathology patients showed the meningothelial meningioma of 18 (43,9%) as the most type found. Fibroplastic meningioma were 8 (19,5%), while atypical meningioma and psammomatous meningioma were 6 (14,6%) each. The rest were malignant meningioma and angiomatous meningioma which found in respectively 2 (4,9%) and 1 (2,4%). Our result found significant finding that mostly male were fibroblastic meningioma (50%), however meningothelial meningioma were found in the majority of female (54,8%) and also seizure comprised only in higher grade meningioma. On the outcome of meningioma patient treated operatively, histopathological grade remained insignificant (p > 0,05). This study can be used as prognostic value of meningioma patients based on gender, histopathological grade, and clinical manifestation. Overall, the outcome of the meningioma’s patients is good and promising as long as it is well managed.

Keywords: meningioma, prognostic value, histopathological grading, clinical manifestation

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Authors: Abdesselam Babouri, Ahcène Lemzadmi, M Rahmane, B. Belhadi, N. Abouchi

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Medical monitoring aims at monitoring and remotely controlling the vital physiological parameters of the patient. The physiological sensors provide repetitive measurements of these parameters in the form of electrical signals that vary continuously over time. Various measures allow informing us about the health of the person's physiological data (weight, blood pressure, heart rate or specific to a disease), environmental conditions (temperature, humidity, light, noise level) and displacement and movements (physical efforts and the completion of major daily living activities). The collected data will allow monitoring the patient’s condition and alerting in case of modification. They are also used in the diagnosis and decision making on medical treatment and the health of the patient. This work presents the implementation of a monitoring system to be used for the control of physiological parameters.

Keywords: clinical monitoring, physiological parameters, biomedical sensors, personal health

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Authors: Abiola Falilat Ibraheem, Akinyimika Sowunmi, Valerie Otti

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Background: Introduction of innovative cancer clinical trials to Nigeria is a critical step in addressing global inequities of cancer burden. Low health and clinical trial literacy among Nigerian patients have been sighted as a significant barrier to ensuring that patients enrolled in clinical trials are truly informed. Video intervention has been shown to be the most proactive method to improving patient’s clinical trial knowledge. In the US, video interventions have been successful at improving education about cancer clinical trials among minority patients. Thus, this study aimed to apply and adapt video interventions addressing attitudinal barriers peculiar to Nigerian patients. Methods: A hospital-based representative mixed-method study was conducted at the Lagos State University Teaching Hospital (LASUTH) from July to December 2020, comprising of cancer patients aged 18 and above. Patients were randomly selected during every clinic day, of which 63 patients volunteered to participate in this study. We first administered a cancer literacy survey to determine patients’ knowledge about clinical trials. For patients who had prior knowledge, a pre-intervention test was administered, after which a 15-minute video (attitudes and intention to enroll in therapeutic clinical trials (AIET)) to improve patients’ knowledge, perception, and attitudes towards clinical trials was played, and then ended by administering a post-intervention test to the patients. For patients who had no prior knowledge, the AIET video was played for them, followed by the post-intervention test. Results: Out of 63 patients sampled, 43 (68.3%) had breast cancer. On average, patients agreed to understand their cancer diagnosis and treatment very well. 84.1% of patients had never heard about cancer clinical trials, and 85.7% did not know what cancer clinical trials were. There was a strong positive relationship (r=0.916) between the pretest and posttest, which means that the intervention improved patients’ knowledge, perception, and attitudes about cancer clinical trials. In the focus groups, patients recommended adapting the video in Nigerian settings and representing all religions in order to address trust in local clinical trialists. Conclusion: Due to the small size of patients, change in clinical trial knowledge was not statistically significant. However, there is a trend suggesting that culturally adapted video interventions can be used to improve knowledge and perception about cancer clinical trials.

Keywords: clinical trials, culturally targeted intervention, patient education, video intervention

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Authors: Maya Agarwala

Abstract:

Objectives: Audit the quality of clinical photographs taken for Orthodontic patients at Queen’s hospital, Romford. Design and setting: All Orthodontic photographs are taken in the Medical Photography Department at Queen’s Hospital. Retrospective audit with data collected between January - March 2023. Gold standard: Institute of Medical Illustrators (IMI) standard 12 photographs: 6 extraoral and 6 intraoral. 100% of patients to have the standard 12 photographs meeting a satisfactory diagnostic quality. Materials and methods: 30 patients randomly selected. All photographs analysed against the IMI gold standard. Results: A total of 360 photographs were analysed. 100% of the photographs had the 12 photographic views. Of which, 93.1% met the gold standard. Of the extraoral photos: 99.4% met the gold standard, 0.6% had incorrect head positioning. Of the intraoral photographs: 87.2% met the gold standard. The most common intraoral errors were: the presence of saliva pooling (7.2%), insufficient soft tissue retraction (3.3%), incomplete occlusal surface visibility (2.2%) and mirror fogging (1.1%). Conclusion: The gold standard was not met, however the overall standard of Orthodontic photographs is high. Further training of the Medical Photography team is needed to improve the quality of photographs. Following the training, the audit will be repeated. High-quality clinical photographs are an important part of clinical record keeping.

Keywords: orthodontics, paediatric, photography, audit

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Authors: Eimar Yadir Quintero Tapias

Abstract:

Background: Science is not generally self-correcting; many clinical studies end with the same conclusion "more research is needed." This study hypothesizes that first, we need a better appraisal of the available (and unavailable) evidence instead of creating more of the same false inquiries. Methods: Systematic review of ClinicalTrials.gov study records using the following Boolean operators: (food OR nut OR milk OR egg OR shellfish OR wheat OR peanuts) AND (allergy OR allergies OR hypersensitivity OR hypersensitivities). Variables included the status of the study (e g., active and completed), availability of results, sponsor type, sample size, among others. To determine the rates of non-publication in journals indexed by PubMed, an advanced search query using the specific Number of Clinical Trials (e.g., NCT000001 OR NCT000002 OR...) was performed. As a prophylactic measure to prevent P-hacking, data analyses only included descriptive statistics and not inferential approaches. Results: A total of 2092 study records matched the search query described above (date: September 13, 2019). Most studies were interventional (n = 1770; 84.6%) and the remainder observational (n = 322; 15.4%). Universities, hospitals, and research centers sponsored over half of these investigations (n = 1208; 57.7%), 308 studies (14.7%) were industry-funded, and 147 received NIH grants; the remaining studies got mixed sponsorship. Regarding completed studies (n = 1156; 55.2%), 248 (21.5%) have results available at the registry site, and 417 (36.1%) matched NCT numbers of journal papers indexed by PubMed. Conclusions: The internal and external validity of human research is critical for the appraisal of medical evidence. It is imperative to analyze the entire dataset of clinical studies, preferably at a patient-level anonymized raw data, before rushing to conclusions with insufficient and inadequate information. Publication bias and non-registration of clinical trials limit the evaluation of the evidence concerning therapeutic interventions for food allergy, such as oral and sublingual immunotherapy, as well as any other medical condition. Over half of the food allergy human research remains unpublished.

Keywords: allergy, clinical trials, immunology, systematic reviews

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Authors: Madaki Umar Yusuf, Mohd Rizam B. Abubakar

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The survival censored data with incomplete covariate data is a common occurrence in many studies in which the outcome is survival time. With model when the missing covariates are categorical, a useful technique for obtaining parameter estimates is the EM by the method of weights. The survival outcome for the class of generalized linear model is applied and this method requires the estimation of the parameters of the distribution of the covariates. In this paper, we propose some clinical trials with ve covariates, four of which have some missing values which clearly show that they were fully censored data.

Keywords: EM algorithm, incomplete categorical covariates, ignorable missing data, missing at random (MAR), Weibull Distribution

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Authors: Claude Takenga, Rolf-Dietrich Berndt, Erling Si, Markus Diem, Guohui Qiao, Melanie Gau, Michael Brandstoetter, Martin Kampel, Michael Dworzak

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In patients with acute lymphoblastic leukaemia (ALL), treatment response is increasingly evaluated with minimal residual disease (MRD) analyses. Flow Cytometry (FCM) is a fast and sensitive method to detect MRD. However, the interpretation of these multi-parametric data requires intensive operator training and experience. This paper presents a pipeline-software, as a ready-to-use FCM-based MRD-assessment tool for the daily clinical practice for patients with ALL. The new tool increases accuracy in assessment of FCM-MRD in samples which are difficult to analyse by conventional operator-based gating since computer-aided analysis potentially has a superior resolution due to utilization of the whole multi-parametric FCM-data space at once instead of step-wise, two-dimensional plot-based visualization. The system developed as a telemedical network reduces the work-load and lab-costs, staff-time needed for training, continuous quality control, operator-based data interpretation. It allows dissemination of automated FCM-MRD analysis to medical centres which have no established expertise for the benefit of an even larger community of diseased children worldwide. We established a telemedical network system for analysis and clinical follow-up and treatment monitoring of Leukaemia. The system is scalable and adapted to link several centres and laboratories worldwide.

Keywords: data security, flow cytometry, leukaemia, telematics platform, telemedicine

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