Search results for: clinical research

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: Ragy Raafat Gaber Attaalla

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Despite having the greatest rates of mortality and morbidity in the world, low- and middle-income (LMIC) nations trail high-income nations in terms of the number of clinical trials, the number of qualified researchers, and the amount of research information specific to their people. Health inequities and the use of precision medicine may be hampered by a lack of local genomic data, clinical pharmacology and pharmacometrics competence, and training opportunities. These issues can be solved by carrying out health care infrastructure development, which includes data gathering and well-designed clinical pharmacology training in LMICs. It will be advantageous if there is international cooperation focused at enhancing education and infrastructure and promoting locally motivated clinical trials and research. This paper outlines various instances where clinical pharmacology knowledge could be put to use, including pharmacogenomic opportunities that could lead to better clinical guideline recommendations. Examples of how clinical pharmacology training can be successfully implemented in LMICs are also provided, including clinical pharmacology and pharmacometrics training programmes in Africa and a Tanzanian researcher's personal experience while on a training sabbatical in the United States. These training initiatives will profit from advocacy for clinical pharmacologists' employment prospects and career development pathways, which are gradually becoming acknowledged and established in LMICs. The advancement of training and research infrastructure to increase clinical pharmacologists' knowledge in LMICs would be extremely beneficial because they have a significant role to play in global health.

Keywords: low- and middle-income, clinical pharmacology, pharmacometrics, career development pathways

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Authors: Maha Salah, Hanaa Hashem, Mahmoud M. Alsagheir, Mohammed Salah

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Acute respiratory distress syndrome (ARDS) represents a complex clinical syndrome and carries a high risk for mortality. The severity of the clinical course, the uncertainty of the outcome, and the reliance on the full spectrum of critical care resources for treatment mean that the entire health care team is challenged. Researchers and clinicians have investigated the nature of the pathological process and explored treatment options with the goal of improving outcome. Through this application of research to practice, we know that some previous strategies have been ineffective, and innovations in mechanical ventilation, sedation, nutrition, and pharmacological intervention remain important research initiatives. Developed Clinical pathway is multidisciplinary plans of best clinical practice for this specified groups of patients that aid in the coordination and delivery of high quality care. They are a documented sequence of clinical interventions that help a patient to move, progressively through a clinical experience to a desired outcome. Although there is a lot of heterogeneity in patients with ARDS, this suggested developed clinical pathway with alternatives was built depended on a lot of researches and evidence based medicine and nursing practices which may be helping these patients to improve outcomes, quality of life and decrease mortality.

Keywords: acute respiratory distress syndrome (ARDS), clinical pathway, clinical syndrome

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Authors: Mamdouh Milad Adly Morkos

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Despite having the greatest rates of mortality and morbidity in the world, low- and middle-income (LMIC) nations trail high-income nations in terms of the number of clinical trials, the number of qualified researchers, and the amount of research information specific to their people. Health inequities and the use of precision medicine may be hampered by a lack of local genomic data, clinical pharmacology and pharmacometrics competence, and training opportunities. These issues can be solved by carrying out health care infrastructure development, which includes data gathering and well-designed clinical pharmacology training in LMICs. It will be advantageous if there is international cooperation focused at enhancing education and infrastructure and promoting locally motivated clinical trials and research. This paper outlines various instances where clinical pharmacology knowledge could be put to use, including pharmacogenomic opportunities that could lead to better clinical guideline recommendations. Examples of how clinical pharmacology training can be successfully implemented in LMICs are also provided, including clinical pharmacology and pharmacometrics training programmes in Africa and a Tanzanian researcher's personal experience while on a training sabbatical in the United States. These training initiatives will profit from advocacy for clinical pharmacologists' employment prospects and career development pathways, which are gradually becoming acknowledged and established in LMICs. The advancement of training and research infrastructure to increase clinical pharmacologists' knowledge in LMICs would be extremely beneficial because they have a significant role to play in global health

Keywords: electromagnetic solar system, nano-material, nano pharmacology, pharmacovigilance, quantum theoryclinical simulation, education, pharmacology, simulation, virtual learning low- and middle-income, clinical pharmacology, pharmacometrics, career development pathways

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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: Abeer Alhazmi

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

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

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Authors: Sedigheh Salemi, Mahnaz Sanjari, Maryam Aalaa, Mohammad Mirzabeigi

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Clinical governance is the framework within which the health service provider is required to ongoing accountability and improvement of the quality of their services. This cross-sectional study was conducted in 661 nurses who work in government hospitals from 35 hospitals of 9 provinces in Iran. The study was approved by the Nursing Council and was carried out with the authorization of the Research Ethics Committee. The questionnaire included 24 questions in which 4 questions focused on clinical governance defining from the nurses' perspective. The reliability was evaluated by Cronbach's alpha (α=0/83). Statistical analyzes were performed, using SPSS version 16. Approximately 40% of nurses correctly answered that clinical governance is not "system of punishment and rewards for the staff". The most nurses believed that "clinical efficacy" is one of the main components of clinical governance. A few of nurses correctly responded that "Evidence Based Practice" and "management" is not part of clinical governance. The small number of nurses correctly answered that the "maintenance of patient records" and "to recognize the adverse effects" is not the role of nurse in clinical governance. Most "do not know" answer was to the "maintenance of patient records". The most nurses unanimously believed that the implementation of clinical governance led to "promoting the quality of care". About a third of nurses correctly stated that the implementation of clinical governance will not lead to "an increase in salaries and benefits of the medical team". As a member of the health team, nurses are responsible in terms of participation in quality improvement and it is necessary to create an environment in which clinical care will flourish and serve to preserve the high standards.

Keywords: clinical governance, nurses, salary, health team

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Authors: Shahad Nagoor, Lucy Hederman, Kevin Koidl, Annalina Caputo

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Doctors’ notes reflect their impressions, attitudes, clinical sense, and opinions about patients’ conditions and progress, and other information that is essential for doctors’ daily clinical decisions. Despite their value, clinical notes are insufficiently researched within the language processing community. Automatically extracting information from unstructured text data is known to be a difficult task as opposed to dealing with structured information such as vital physiological signs, images, and laboratory results. The aim of this research is to investigate how Natural Language Processing (NLP) techniques and machine learning techniques applied to clinician notes can assist in doctors’ decision-making in Intensive Care Unit (ICU) for coronavirus disease 2019 (COVID-19) patients. The hypothesis is that clinical outcomes like survival or mortality can be useful in influencing the judgement of clinical sentiment in ICU clinical notes. This paper introduces two contributions: first, we introduce COVID_ICU_BERT, a fine-tuned version of clinical transformer models that can reliably predict clinical sentiment for notes of COVID patients in the ICU. We train the model on clinical notes for COVID-19 patients, a type of notes that were not previously seen by clinicalBERT, and Bio_Discharge_Summary_BERT. The model, which was based on clinicalBERT achieves higher predictive accuracy (Acc 93.33%, AUC 0.98, and precision 0.96 ). Second, we perform data augmentation using clinical contextual word embedding that is based on a pre-trained clinical model to balance the samples in each class in the data (survived vs. deceased patients). Data augmentation improves the accuracy of prediction slightly (Acc 96.67%, AUC 0.98, and precision 0.92 ).

Keywords: BERT fine-tuning, clinical sentiment, COVID-19, data augmentation

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Authors: Vivian Isaac, A. T. Joteeshwaran, Craig McLachlan

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The University of New South Wales (UNSW) Rural Clinical School has a strategic collaborative focus on chronic disease and public health. Our objectives are to understand rural environmental and biological interactions in vulnerable community populations. The UNSW Rural Clinical School translational model is a spoke and hub network. This spoke and hub model connects rural data and biological specimens with city based collaborative public health research networks. Similar spoke and hub models are prevalent across research centers in India. The Australia-India Council grant was awarded so we could establish sustainable public health and community research collaborations. As part of the collaborative network we are developing strategies around data and biological sharing platforms between Indian Institute of Public Health, Public Health Foundation of India (PHFI), Hyderabad and Rural Clinical School UNSW. The key objective is to understand how research collaborations are conducted in India and also how data can shared and tracked with external collaborators such as ourselves. A framework to improve data sharing for research collaborations, including DNA was proposed as a project outcome. The complexities of sharing biological data has been investigated via a visit to India. A flagship sustainable project between Rural Clinical School UNSW and PHFI would illustrate a model of data sharing platforms.

Keywords: data sharing, collaboration, public health research, chronic disease

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Authors: Jonah Kenei, Elisha Opiyo

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Electronic health records, as a repository of patient information, is nowadays the most commonly used technology to record, store and review patient clinical records and perform other clinical tasks. However, the accurate identification and retrieval of relevant information from clinical records is a difficult task due to the unstructured nature of clinical documents, characterized in particular by a lack of clear structure. Therefore, medical practice is facing a challenge thanks to the rapid growth of health information in electronic health records (EHRs), mostly in narrative text form. As a result, it's becoming important to effectively manage the growing amount of data for a single patient. As a result, there is currently a requirement to visualize electronic health records (EHRs) in a way that aids physicians in clinical tasks and medical decision-making. Leveraging text visualization techniques to unstructured clinical narrative texts is a new area of research that aims to provide better information extraction and retrieval to support clinical decision support in scenarios where data generated continues to grow. Clinical datasets in electronic health records (EHR) offer a lot of potential for training accurate statistical models to classify facets of information which can then be used to improve patient care and outcomes. However, in many clinical note datasets, the unstructured nature of clinical texts is a common problem. This paper examines the very issue of getting raw clinical texts and mapping them into meaningful structures that can support healthcare professionals utilizing narrative texts. Our work is the result of a collaborative design process that was aided by empirical data collected through formal usability testing.

Keywords: classification, electronic health records, narrative texts, visualization

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Authors: Maria Pratt, Lynn Martin

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Context: In nursing education, clinical instructors are crucial in assessing and evaluating students' performance in clinical courses. However, instructors often struggle when assigning failing grades to students at risk of failing. Research Aim: This qualitative study aims to understand clinical instructors' experiences evaluating students with unsatisfactory performance, including how reflection and collegial support impact this evaluation process. Methodology, Data Collection, and Analysis Procedures: This study employs Gadamer's Hermeneutic Inquiry as the research methodology. A purposive maximum variation sampling technique was used to recruit eight clinical instructors from a collaborative undergraduate nursing program in Southwestern Ontario. Semi-structured, open-ended, and audio-taped interviews were conducted with the participants. The hermeneutic analysis was applied to interpret the interview data to allow for a thorough exploration and interpretation of the instructors' experiences evaluating failing students. Findings: The main findings of this qualitative research indicate that evaluating failing students was emotionally draining for the clinical instructors who experienced multiple challenges, uncertainties, and negative feelings associated with assigning failing grades. However, the analysis revealed that ongoing reflection and collegial support played a crucial role in mitigating the challenges they experienced. Conclusion: This study contributes to the theoretical understanding of nursing education by shedding light on clinical instructors' challenges in evaluating failing students. It emphasizes the emotional toll associated with this process and the role that reflection and collegial support play in alleviating those challenges. The findings underscore the need for ongoing professional development and support for instructors in nursing education. By understanding and addressing clinical instructors' experiences, nursing education programs can better equip them to effectively evaluate struggling students and provide the necessary support for their professional growth.

Keywords: clinical instructor, student evaluation, nursing, reflection, support

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Authors: J. Magerman, P. Martin

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Nursing students' clinical abilities is highly dependent on the quality of the clinical experience obtained while placed in the clinical environment. The clinical environment has amongst other, key role players which include the clinical supervisor. The primary role of the clinical supervisor is to guide nursing students to become the best practice nursing professionals. However, globally literature alludes to the failure of educating institutions to deliver competent nursing professionals to meet the needs of patients and deliver quality patient care. At the participating university, this may be due to various factors such as large student numbers and social and environmental challenges experienced by clinical supervisors. The aim of this study was to explore and describe the lived experiences of clinical supervisors who supervise nursing students at a higher education institution. The study employed a qualitative research approach utilizing a descriptive phenomenological design. Purposive sampling was used to select participants, who supervised first and second year nursing studnets at the higher education institution under study. TH esample comprised of eight clinical supervisors who supervise first and secon year nursing studnets at teh institution under study. Data was collected by means of in-depht interviews. Data was analysed using Collaizzi's seven steps method of qualitative analysis. Five major themes identified , focussed on the experiences regarding time a sa constraint to job productivity, the impact of teh organisational culture on the fluidity of support, interpersonal relationships a sa dynamic communication process, impact on the self, and limited resources. Trustworthiness of the data was ensured by means of applying Guba's model of truth value, applicability, consistency and neutrality. Reflexivity was also used by the researcher to further enhance trustworthiness.

Keywords: clinical supervision, clinical supervisors, nursing students, clinical placements

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Authors: Ibraheem Husain, Abul Kalam Najmi, Karishma Chester

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

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

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Authors: 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: Maria Monica D. Espinosa

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This study aimed to identify and examine the characteristics of an effective leader in a Hospital institution from the perspectives of military nurse-managers. The researcher extracted the different facets of leadership from the stories of six nurse- managers from a military hospital. The stories which are in pre-reflective stage convey an unbiased perspective from which clinical leadership may be defined. Using Phenomenology as a method of Research, the lived experiences of the military nurse-managers served as empirical data which were reflected upon until the formulation of insights. The information from the co-researchers became gallows from which the characteristics of effective leadership in the clinical area were drawn. These insights were synthesized through layers of reflection that resulted to the knowledge about clinical leadership. The reflections are the following, (a) Clinical leaders develop their skills through experiences and hardwork; (b) Clinical leaders are devoted; (c) Clinical leaders are focused; (d) Clinical leaders are good in interpersonal relationship; (e) Clinical leaders are mentors; (f) Clinical leaders seek affirmation and recognition; and (g) Clinical leaders are responsible and dependable. The common themes that emerged from the nurse manager’s stories showed that clinical leadership maybe attained if leaders possessed the following traits, (a) The gift to establish a steadfast and firm management; (b) The proficiency to guide and encourage others towards the achievement of their goals and objectives; (c) The ability to instigate participative and collaborative work among his/her subordinates and (d) The aptitude and skill to address the institutional concerns in their unit. In the future, Clinical leaders should continually adapt an evaluation program on how they can relate socially with their subordinates, the result of which can be used as a basis in developing strategies on relationship enhancement. Moreover, they should empower the nurses by allowing them to voice out their opinions and concerns regarding assignments, role expectations, and workload issues to improve and strengthen the relationships among nurses. Lastly, they can incorporate a collaborative strategy to promote professional socialization attitudes of nurse managers who work with staff nurses to improve the quality of their proficiencies and enhance a positive clinical environment.

Keywords: clinical leadership, experiences, implications, military nurse - managers, phenomenology

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Authors: Mahera Abdulrahman, Satish Chandrasekhar Nair

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Growing demand for human health research in the United Arab Emirates (UAE) has prompted the need to develop a robust research ethics oversight, particularly given the large unskilled-worker immigrant population and the elderly citizens utilizing health services. Examination of the structure, function, practices and outcomes of the human research ethics committees (HREC) was conducted using two survey instruments, reliable and validated. Results indicate that in the absence of a national ethics regulatory body, the individual emirate’s governed 21 HRECs covering health facilities and academic institutions in the UAE. Among the HRECs, 86% followed International Council for Harmonization-Good Clinical Practice guidelines, 57% have been in operation for more than five years, 81% reviewed proposals within eight weeks, 48% reviewed for clinical and scientific merit apart from ethics, and 43% handled more than 50 research proposals per year. However, researcher recognition, funding transparency, adverse event reporting systems were widespread in less than one-third of all HRECs. Surprisingly, intellectual property right was not included as a research output. Research was incorporated into the vision and mission statements of many (62%) organizations and, mechanisms such as research publications, collaborations, and recognitions were employed as key performance indicators to measure research output. In spite, resources to generate research output such as dedicated budget (19%), support staff (19%) and continuous training and mentoring program for medical residents and HREC members were somehow lacking. HREC structure and operations in the UAE are similar to other regions of the world, resources allocation for efficient, quality monitoring, continuous training, and the creation of a clinical research network are needed to strengthen the clinical research enterprise to scale up for the future. It is anticipated that the results of this study will benefit investigators, regulators, pharmaceutical sponsors and the policy makers in the region.

Keywords: institutional review board, ethics committee, human research ethics, United Arab Emirates (UAE)

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

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

Keywords: cell therapy, clinical adoption, commercialization, translation

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Authors: Senait Belay Adugna, Mirutse Giday, Tsegahun Manyazewal

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Background: The emergence and resurgence of zoonotic diseases have continued to be a major threat to global health and the economy. Developing countries are particularly vulnerable due to agricultural expansions and the domestication of animals by humans. Scientifically sound clinical trials are important to find better ways to prevent, diagnose, and treat zoonotic diseases, while there is a lack of evidence to inform the clinical trials’ capacity and practice in countries highly affected by the diseases. This study aimed to investigate researchers’ perceptions and experiences in conducting clinical trials on zoonotic diseases in Ethiopia. Methods: This study employed a descriptive, qualitative study design. It included major academic and research institutions in Ethiopia that had active engagements in veterinary and public health research. It included the National Veterinary Institute, the National Animal Health Diagnostic and Investigation Center, the College of Veterinary Medicine at Addis Ababa University, the Ethiopian Public Health Institute, the Armauer Hansen Research Institute, and the College of Health Sciences at Addis Ababa University. In-depth interviews were conducted with 14 senior researcher investigators in the institutions who hold a proven exhibit primarily leading research activities or research units. Data were collected from October 2019 to April 2020. Data analysis was undertaken using open code 4.03 for qualitative data analysis. Results: Five major themes, with 18 sub-themes, emerged from the in-depth interview in connection. These were: challenges in the prevention, control, and treatment of zoonotic diseases; One Health approach to mitigate zoonotic diseases; personal and institutional experiences in conducting clinical trials on zoonotic diseases; barriers in conducting clinical trials towards zoonotic diseases; and strategies that promote conducting clinical trials on zoonotic diseases. Conducting clinical trials on zoonotic diseases in Ethiopia is hampered by a lack of clearly articulated ethics and regulatory frameworks, trial experts, financial resources, and good governance. Conclusions: In Ethiopia, conducting clinical trials on zoonotic diseases deserves due attention. Strengthening institutional and human resources capacity is a precondition to harnessing effective implementation of clinical trials on zoonotic diseases in the country. In Ethiopia, where skilled human resource is scarce, the One Health approach has the potential to form multidisciplinary teams to systematically improve clinical trials capacity and outcomes in the country.

Keywords: Ethiopia, clinical triak, zoonoses, disease

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Authors: Matej Stritesky

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The research deals with the connection between the Schwartz Theory of Basic Values and the ethical principles in psychology, on which the meta-code of ethics the European Federation of Psychological Associations is based. The research focuses on ethically problematic situations in clinical psychology in the Czech Republic. Based on the analysis of papers that identified ethically problematic situations faced by clinical psychologists, a questionnaire of ethically problematic situations in clinical psychology (EPSCP) was created for the purposes of the research. The questionnaire was created to represent situations that correspond to the 4 principles on which the meta-code of ethics the European Federation of Psychological Associations is based. The questionnaire EPSCP consists of descriptions of 32 situations that respondents evaluate on a scale from 1 (psychologist's behaviour is ethically perfectly fine) to 10 (psychologist's behaviour is ethically completely unacceptable). The EPSCP questionnaire, together with Schwartz's PVQ questionnaire, will be presented to 60 psychology students. The relationship between principles in clinical psychology and the values on Schwartz´s value continuum will be described using multidimensional scaling. A positive correlation is assumed between the higher-order value of openness to change and problematic ethical situations related to the principle of integrity; a positive correlation between the value of the higher order of self-transcendence and the principle of respect and responsibility; a positive correlation between the value of the higher order of conservation and the principle of competence; and negative correlation between the value of the higher order of ego strengthening and sensitivity to ethically problematic situations. The research also includes an experimental part. The first half of the students are presented with the code of ethics of the Czech Association of Clinical Psychologists before completing the questionnaires, and to the second half of the students is the code of ethics presented after completing the questionnaires. In addition to reading the code of ethics, students describe the three rules of the code of ethics that they consider most important and state why they chose these rules. The output of the experimental part will be to determine whether the presentation of the code of ethics leads to greater sensitivity to ethically problematic situations.

Keywords: clinical psychology, ethically problematic situations in clinical psychology, ethical principles in psychology, Schwartz theory of basic values

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Authors: Dries Dulsster

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

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

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Authors: 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: Vandita Mishra

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From the management of patients, reception, record, and assistants in a clinical practice; to the management of ongoing research, clinical cases and department profile in an academic setup, the healthcare provider has to deal with all of it. The victory lies in smooth running of the show in both the above situations with an apt solution of problems encountered and smooth management of crisis faced. Thus this paper amalgamates dental science with health administration by means of introduction of a concept for practice management and problem-solving called 'Quality Circles'. This concept uses various tools for problem solving given by experts from different fields. QC tools can be applied in both clinical and academic settings in dentistry for better productivity and for scientifically approaching the process of continuous improvement in both the categories. When approached through QC, our organization showed better patient outcomes and more patient satisfaction. Introduced in 1962 by Kaoru Ishikawa, this tool has been extensively applied in certain fields outside dentistry and healthcare. By exemplification of some clinical cases and virtual scenarios, the tools of Quality circles will be elaborated and discussed upon.

Keywords: academics, dentistry, healthcare, quality

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Authors: Poglajen Andrej, Malečihar Špela

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Social work in rehabilitation needs constant development and embetterment of its practitioners. This became even more evident during the covid pandemic at times when outside sources of help, care and support were non-existent, or the access to such sources was severely limited. Social workers are, at our core, researchers of the rehabilitated world – from a personal and intrapersonal to a systematic perspective. This is also why a method of research was used in order to see if clinical social work practice can be further improved. The first stage of research showcased how action research and social work practice share many of the core values, whereas the Implementation of the new behaviour principle was severely lacking and thus became the main focus of the follow-up research. Twenty randomly selected case files of clinical social work practice in rehabilitation were qualitatively analyzed and potential benefits of action research on practice were assessed in the process of intervention while also getting feedback of the usefulness by the patients themselves using pre and post evaluation forms where a mixed-method approach was used. Implementation of new behaviour principle was recognized as a potential, improving factor of clinical social work practice in most analyzed cases, while it wasn’t deemed necessary in all of them. Potential improvements of newly implemented behaviour span across different areas of life and were also noted in the feedback from the rehabilitates. Despite the benefits of practice embetterment, the inclusion and focus on Implementation of new behaviour principle also caused additional workload, lack of time and stressful situations for the practitioners, which showcased the need to address certain systemic obstacles in the context of social work in healthcare in Slovenia.

Keywords: action research, practice, rehabilitation, social work

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Authors: Yoon Chung Kim

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In this coming aging society, medical device industry is expected to become one of the major industries. Since developing medical devices usually requires technology convergence, research collaboration is important, especially for some small and medium enterprises (SMEs) that do not have enough R&D resources in each related field. Collaboration in medical device development has some unique properties. Since it requires convergence technology, collaboration with different fields, and different types of people are often required. Since it requires clinical test, the development process usually takes longer and collaboration with hospitals is also required. However, despite these importance and uniqueness, collaboration in medical device development has not yet been widely studied. Thus, our research focuses on investigating collaborations in medical device development. For our research, we conducted surveys and interviews, especially with SMEs’ perspective in Korea. The result and discussion will be presented with a major impact factors for collaboration result, as well as future strategies that will improve and strengthen collaboration process in medical devices.

Keywords: medical device, SME, research collaboration, development, clinical

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Authors: Hye-Kyung Kang

Abstract:

Social justice is a central principle of the social work profession and education. However, scholars have long questioned the profession’s commitment to putting social justice values into practice. Clinical social work has been particularly criticized for its lack of attention to social justice and for failing to address the concerns of the oppressed. One prominent criticism of clinical social work is that it often relies on individual intervention and fails to take on system-level changes or advocacy. This concern evokes the historical macro-micro tension of the social work profession where micro (e.g., mental health counseling) and macro (e.g., policy advocacy) practices are conceptualized as separate domains, creating a false binary for social workers. One contributor to this false binary seems to be that most clinical practice models do not prepare social work students and practitioners to make a clear link between clinical practice and social justice. This paper presents a model of clinical social work practice that clearly recognizes the essential and necessary connection between social justice, advocacy, and clinical practice throughout the clinical process: engagement, assessment, intervention, and evaluation. Contemporary relational theories, critical social work frameworks, and anti-oppressive practice approaches are integrated to build a clinical social work practice model that addresses the urgent need for mental health practice that not only helps and heals the person but also challenges societal oppressions and aims to change them. The application of the model is presented through case vignettes.

Keywords: social justice, clinical social work, clinical social work model, integrative model

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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: Nanyombi Lubimbi, Josette Niyokindi

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Background: As in many other developing countries in Africa, Rwanda suffers from a chronic shortage of skilled Health Care professionals including Clinical Instructors. This shortage negatively affects the clinical instruction quality therefore impacting student-learning outcomes. Due to poor clinical supervision, it is often noted that students have no structure or consistent guidance in their learning process. The Clinical Educators and the Rwandan counterparts identified the need to create a favorable environment for learning. Description: During orientation the expectations of the student learning process, collaboration of the clinical instructors with the nurses and Clinical Educators is outlined. The ward managers facilitate structured learning by helping the students identify a maximum of two patients using the school’s objectives to guide the appropriate selection of patients. Throughout the day, Clinical Educators with collaboration of Clinical Instructors when present conduct an ongoing assessment of learning and provide feedback to the students. Post-conference is provided once or twice a week to practice critical thinking skills of patient cases that they have been taking care of during the day. Lessons Learned: The students are found to be more confident with knowledge and skills gained during rotations. Clinical facility evaluations completed by students at the end of their rotations highlight the student’s satisfaction and recommendation for continuation of structured learning. Conclusion: Based on the satisfaction of both students and Clinical Instructors, we have identified need for structured learning during clinical rotations. We acknowledge that more evidence-based practice is necessary to effectively address the needs of nursing and midwifery students throughout the country.

Keywords: Rwanda, clinical rotation, structured learning, critical thinking skills, post-conference

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Authors: Eimar Yadir Quintero Tapias

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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: A. Satty, H. Mwambi

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Much clinical trials data-based research are characterized by the unavoidable problem of dropout as a result of missing or erroneous values. This paper aims to review some of the various techniques to address the dropout problems in longitudinal clinical trials. The fundamental concepts of the patterns and mechanisms of dropout are discussed. This study presents five general techniques for handling dropout: (1) Deletion methods; (2) Imputation-based methods; (3) Data augmentation methods; (4) Likelihood-based methods; and (5) MNAR-based methods. Under each technique, several methods that are commonly used to deal with dropout are presented, including a review of the existing literature in which we examine the effectiveness of these methods in the analysis of incomplete data. Two application examples are presented to study the potential strengths or weaknesses of some of the methods under certain dropout mechanisms as well as to assess the sensitivity of the modelling assumptions.

Keywords: incomplete longitudinal clinical trials, missing at random (MAR), imputation, weighting methods, sensitivity analysis

Procedia PDF Downloads 378