Search results for: clinical benefit

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: Sau Kam Adeline Chan

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World Health Organization had listed ‘Communication during Patient Care Handovers’ as one of its highest 5 patient safety initiatives. Clinical handover means transfer of accountability and responsibility of clinical information from one health professional to another. The main goal of clinical handover is to convey patient’s current condition and treatment plan accurately. Ineffective communication at point of care is globally regarded as the main cause of the sentinel event. Situation, Background, Assessment and Recommendation (SBAR), a communication tool, is extensively regarded as an effective communication tool in healthcare setting. Nonetheless, just by scenario-based program in nursing school or attending workshops on SBAR would not be enough for freshly graduated nurses to apply it competently in a complex clinical practice. To what extend and in-depth of information should be conveyed during handover process is not easy to learn. As such, on-site coaching is essential to upgrade their expertise on the usage of SBAR and ultimately to avoid any clinical error. On-site coaching for all freshly graduated nurses on the usage of SBAR in clinical handover was commenced in August 2014. During the preceptorship period, freshly graduated nurses were coached by the preceptor. After that, they were gradually assigned to take care of a group of patients independently. Nurse leaders would join in their shift handover process at patient’s bedside. Feedback and support were given to them accordingly. Discrepancies on their clinical handover process were shared with them and documented for further improvement work. Owing to the constraint of manpower in nurse leader, about coaching for 30 times were provided to a nurse in a year. Staff satisfaction survey was conducted to gauge their feelings about the coaching and look into areas for further improvement. Number of clinical error avoided was documented as well. The nurses reported that there was a significant improvement particularly in their confidence and knowledge in clinical handover process. In addition, the sense of empowerment was developed when liaising with senior and experienced nurses. Their proficiency in applying SBAR was enhanced and they become more alert to the critical criteria of an effective clinical handover. Most importantly, accuracy of transferring patient’s condition was improved and repetition of information was avoided. Clinical errors were prevented and quality patient care was ensured. Using SBAR as a communication tool looks simple. The tool only provides a framework to guide the handover process. Nevertheless, without on-site training, loophole on clinical handover still exists, patient’s safety will be affected and clinical error still happens.

Keywords: freshly graduated nurse, competency of clinical handover, quality, clinical error

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Authors: Samad Lotfollahzadeh

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

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

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

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

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

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Authors: R. Tariq, R. Lee

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Background: Additional demands placed on senior clinical teams with ongoing COVID-19 management has accelerated the need to harness the wider healthcare professional resources and upskill them to take on greater clinical responsibility safely. The UK NHS Long Term Plan (2019)¹ emphasises the importance of expanding Advanced Practitioners’ (APs) roles to take on more clinical diagnostic responsibilities to cope with increased demand. In acute settings, APs are often the first point of care for patients and require training to take on initial triage responsibilities efficiently and safely. Critically, their roles include determining which onward services the patients may require, and assessing whether they can be treated at home, avoiding unnecessary admissions to the hospital. Dem Dx is a Clinical Reasoning Platform (CRP) that claims to help frontline healthcare professionals independently assess and triage patients. It guides the clinician from presenting complaints through associated symptoms to a running list of differential diagnoses, media, national and institutional guidelines. The objective of this study was to compare the clinical referral rates and guidelines adherence registered by the HMR Urgent Community Care Team (UCCT)² and Dem Dx recommendations using retrospective cases. Methodology: 192 cases seen by the UCCT were anonymised and reassessed using Dem Dx clinical pathways. We compared the UCCT’s performance with Dem Dx regarding the appropriateness of onward referrals. We also compared the clinical assessment regarding adherence to NICE guidelines recorded on the clinical notes and the presence of suitable guidance in each case. The cases were audited by two medical doctors. Results: Dem Dx demonstrated appropriate referrals in 85% of cases, compared to 47% in the UCCT team (p<0.001). Of particular note, Dem Dx demonstrated an almost 65% (p<0.001) improvement in the efficacy and appropriateness of referrals in a highly experienced clinical team. The effectiveness of Dem Dx is in part attributable to the relevant NICE and local guidelines found within the platform's pathways and was found to be suitable in 86% of cases. Conclusion: This study highlights the potential of clinical decision support, as Dem Dx, to improve the quality of onward clinical referrals delivered by a multidisciplinary team in primary care. It demonstrated that it could support healthcare professionals in making appropriate referrals, especially those that may be overlooked by providing suitable clinical guidelines directly embedded into cases and clear referral pathways. Further evaluation in the clinical setting has been planned to confirm those assumptions in a prospective study.

Keywords: advanced practitioner, clinical reasoning, clinical decision-making, management, multidisciplinary team, referrals, triage

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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: Junhong Li, Danni Cheng, Yaxin Luo, Xiaowei Yi, Ke Qiu, Wendu Pang, Minzi Mao, Yufang Rao, Yao Song, Jianjun Ren, Yu Zhao

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Background: The number of multiple cancer patients was increasing, and the impact of prior cancer history on salivary gland cancer patients remains unclear. Methods: Clinical, demographic and pathological information on salivary gland cancer patients were retrospectively collected from the Surveillance, Epidemiology, and End Results (SEER) database from 2004 to 2017, and the characteristics and prognosis between patients with a prior cancer and those without prior caner were compared. Univariate and multivariate cox proportional regression models were used for the analysis of prognosis. A risk score model was established to exam the impact of treatment on patients with a prior cancer in different risk groups. Results: A total of 9098 salivary gland cancer patients were identified, and 1635 of them had a prior cancer history. Salivary gland cancer patients with prior cancer had worse survival compared with those without a prior cancer (p<0.001). Patients with a different type of first cancer had a distinct prognosis (p<0.001), and longer latent time was associated with better survival (p=0.006) in the univariate model, although both became nonsignificant in the multivariate model. Salivary gland cancer patients with a prior cancer were divided into low-risk (n= 321), intermediate-risk (n=223), and high-risk (n=62) groups and the results showed that patients at high risk could benefit from surgery, radiation therapy, and chemotherapy, and those at intermediate risk could benefit from surgery. Conclusion: Prior cancer history had an adverse impact on the survival of salivary gland cancer patients, and individualized treatment should be seriously considered for them.

Keywords: prior cancer history, prognosis, salivary gland cancer, SEER

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

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

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

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Authors: James Moir

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This paper considers the political controversy in Britain, both pre- and post-EU referendum, concerning claims over welfare benefit tourism and immigration in the UK. These claims were seen to be a significant reason for the vote for Brexit despite evidence to the contrary that benefit tourism was not, and is not, implicated in the migration of East Europeans to the UK. Populist rhetoric is analysed alongside studies that contradict such views. These contentious issues are examined with respect to the agenda set by the United Kingdom Independence Party (UKIP) concerning anti-EU and anti-immigrant sentiment and the notion of cultural differences as the basis for supporting Brexit. The paper also examines the paradoxical claim that East European migrants are taking British jobs and driving down wages. Taken together, it is argued that these two kinds of claims effectively contribute to anti-immigration discourse based on the logic of economics, but also at the same time conceal more irrational fears of adapting to change through the inclusion of others. Such fears are considered as being founded upon a challenge to the stability of totems of national life and identity.

Keywords: benefits, Brexit, immigration, tourism, welfare

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Authors: Ibraheem Husain, Abul Kalam Najmi, Karishma Chester

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

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

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Authors: Ji-Chan Jang

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

Keywords: tuberculosis, daptomycin, resistance, Mycobacterium tuberculosis

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Authors: Misun Kim, Beomsoo Park

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Korean government has strongly supported SMEs financially and technically. It has also changed R&D manpower management so that SMEs can benefit from the knowledge of highly qualified experts. This study evaluates the impacts of such policy on SMEs and analyzes the factors affecting the growth of the firms. Then we compare the characteristics of high growth companies to general companies. This factors could be use in the future for identifying firms that would significantly benefit from manpower help.

Keywords: dispatch human Ccapital, high growth, science and technology policy, SMEs

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Authors: Nagwa E. Abd Elazim, Maha S. El-naggar, Rania H. Mohamed, Sara M. Awad

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Background: Radiodermatitis is a common side effect of radiation therapy for breast cancer. However, there is no current consensus about effective standard therapy for the prevention and management of radiation dermatitis. Topical ectoine has demonstrated efficacy in the treatment of atopic dermatitis owing to its anti-inflammatory activity. Objective: To evaluate the efficacy of topical ectoine in comparison to traditional topical dexpanthenol treatment in the management of acute radiodermatitis in breast cancer patients undergoing adjuvant radiotherapy. Methods: Fifty patients were randomized to use either dexpanthenol 0.5% cream (25 patients), or ectoin 7% cream (25 patients), applied twice daily to the irradiated area during the radiation period and continued for 2 weeks after cessation of radiotherapy. Assessment of radiation skin toxicity using Common Terminology Criteria of Adverse Events (CTCAE) v4.0, radiation-associated symptoms, and adverse events were undertaken weekly during radiotherapy and 2 weeks after the end of radiotherapy. Results: Topical ectoine showed some clinical benefit over dexpanthenol, as shown by delayed time to onset (at week 3 versus week 2, respectively) and larger number of patients who reached grade 0 at the end of treatment (64% vs. 48%, respectively). The clinical symptoms of pain (p = 0.003) and itching (p = 0.001) attributable to radiation were less pronounced with ectoine than with dexpanthenol. Burning and hyperpigmentation were the most common side effects with ectoine. However, no significant difference between dexpanthenol and ectoine treatments was found in any of the side effects (p = 0.1). Conclusion: Ectoin was overall more effective in improving radiation dermatitis than topical dexpanthenol in breast cancer patients. Ectoin could be proposed as a preventive or curative treatment for patients undergoing postoperative irradiation for breast cancer. Further clinical studies with a larger number of patients are recommended for the confirmation of these preliminary results.

Keywords: breast cancer, dexapanthenol, ectoin, radiation dermatitis

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

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

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

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Authors: 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: Simone Huber, Bianca Schnalzer, Baptiste Alcalde, Sten Hanke, Lampros Mpaltadoros, Thanos G. Stavropoulos, Spiros Nikolopoulos, Ioannis Kompatsiaris, Lina Pérez- Breva, Vallivana Rodrigo-Casares, Jaime Fons-Martínez, Jeroen de Bruin

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Developing new medicine and health solutions and improving patient health currently rely on the successful execution of clinical trials, which generate relevant safety and efficacy data. For their success, recruitment and retention of participants are some of the most challenging aspects of protocol adherence. Main barriers include: i) lack of awareness of clinical trials; ii) long distance from the clinical site; iii) the burden on participants, including the duration and number of clinical visits and iv) high dropout rate. Most of these aspects could be addressed with a new paradigm, namely the Remote Decentralized Clinical Trials (RDCTs). Furthermore, the COVID-19 pandemic has highlighted additional advantages and challenges for RDCTs in practice, allowing participants to join trials from home and not depend on site visits, etc. Nevertheless, RDCTs should follow the process and the quality assurance of conventional clinical trials, which involve several processes. For each part of the trial, the Building Blocks, existing software and technologies were assessed through a systematic search. The technology needed to perform RDCTs is widely available and validated but is yet segmented and developed in silos, as different software solutions address different parts of the trial and at various levels. The current paper is analyzing the availability of technology to perform RDCTs, identifying gaps and providing an overview of Basic Building Blocks and functionalities that need to be covered to support the described processes.

Keywords: architectures and frameworks for health informatics systems, clinical trials, information and communications technology, remote decentralized clinical trials, technology availability

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Authors: Rashida Suleiman, Asamoah Jnr. Boakye, Suleiman Ahmed Ibn Ahmed

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In recent years, there has been an enormous success in discoveries of scientific knowledge in medicine coupled with the advancement of technology. Despite all these successes, diagnoses and treatment of diseases have become complex. MYCIN is a groundbreaking illustration of a clinical decision support system (CDSS), which was developed to assist physicians in the diagnosis and treatment of bacterial infections by providing suggestions for antibiotic regimens. MYCIN was one of the earliest expert systems to demonstrate how CDSSs may assist human decision-making in complicated areas. Relevant databases were searched using google scholar, PubMed and general Google search, which were peculiar to clinical decision support systems. The articles were then screened for a comprehensive overview of the functionality, consultative style and statistical usage of MYCIN, a clinical decision support system. Inferences drawn from the articles showed some usage of MYCIN for problem-based learning among clinicians and students in some countries. Furthermore, the data demonstrated that MYCIN had completed clinical testing at Stanford University Hospital following years of research. The system (MYCIN) was shown to be extremely accurate and effective in diagnosing and treating bacterial infections, and it demonstrated how CDSSs might enhance clinical decision-making in difficult circumstances. Despite the challenges MYCIN presents, the benefits of its usage to clinicians, students and software developers are enormous.

Keywords: clinical decision support system, MYCIN, diagnosis, bacterial infections, support systems

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Authors: Yutong Xu, Wanting Zhang, Jia Wang, Zihan Guo, Weiguang Ma

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Background: The resilience education of intern nursing students has significant implications for the development and improvement of the nursing workforce. The clinical internship period is a critical time for enhancing resilience. Aims: To evaluate the resilience level of Chinese nursing interns and identify the factors affecting resilience early in their careers. Methods: The cross-sectional study design was adopted. From March 2022 to May 2023, 512 nursing interns in tertiary care hospitals were surveyed online with the Connor-Davidson Resilience Scale, the Clinical Learning Environment scale for Nurse, and the Career Adapt-Abilities Scale. Structural equation modeling was used to clarify the relationships among these factors. Indirect effects were tested using bootstrapped Confidence Intervals. Results: The nursing interns showed a moderately high level of resilience[M(SD)=70.15(19.90)]. Gender, scholastic attainment, had a scholarship, career adaptability and clinical learning environment were influencing factors of nursing interns’ resilience. Career adaptability and clinical learning environment positively and directly affected their resilience level (β = 0.58, 0.12, respectively, p＜0.01). career adaptability also positively affected career adaptability (β = 0.26, p < 0.01), and played a fully mediating role in the relationship between clinical learning environment and resilience. Conclusion: Career adaptability can enhance the influence of clinical learning environment on resilience. The promotion of career adaptability and the clinical teaching environment should be the potential strategies for nursing interns to improve their resilience, especially for those female nursing interns with low academic performance. Implications for Nursing Educators Nursing educators should pay attention to the cultivation of nursing students' resilience; for example, by helping them integrate to the clinical learning environment and improving their career adaptability. Reporting Method: The STROBE criteria were used to report the results of the observations critically. Patient or Public Contribution No patient or public contribution.

Keywords: resilience, clinical learning environment, career adaptability, nursing interns

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Authors: Kamal Tolani, Sandeep Kumar, Rohit Luthra, Ankit Dadhania, Krishnaprasad K., Ram Gupta, Deepa Joshi

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Background: Post-operative analgesia remains a clinical challenge, with central and peripheral sensitization playing a pivotal role in treatment-related complications and impaired quality of life. Centrally acting opioids offer poor risk benefit profile with increased intensity of gastrointestinal or central side effects and slow onset of clinical analgesia. The objective of this study was to assess the clinical feasibility of induction and maintenance therapy with Tapentadol Nasal Spray (NS) in moderate to severe acute post-operative pain. Methods: Phase III, randomized, active-controlled, non-inferiority clinical trial involving 294 cases who had undergone surgical procedures under general anesthesia or regional anesthesia. Post-surgery patients were randomized to receive either Tapentadol NS 45 mg or Tramadol 100mg IV as a bolus and subsequent 50 mg or 100 mg dose over 2-3 minutes. The frequency of administration of NS was at every 4-6 hours. At the end of 24 hrs, patients in the tramadol group who had a pain intensity score of ≥4 were switched to oral tramadol immediate release 100mg capsule until the pain intensity score reduced to <4. All patients who had achieved pain intensity ≤ 4 were shifted to a lower dose of either Tapentadol NS 22.5 mg or oral Tramadol immediate release 50mg capsule. The statistical analysis plan was envisaged as a non-inferiority trial involving comparison with Tramadol for Pain intensity difference at 60 minutes (PID60min), Sum of Pain intensity difference at 60 minutes (SPID60min), and Physician Global Assessment at 24 hrs (PGA24 hrs). Results: The per-protocol analyses involved 255 hospitalized cases undergoing surgical procedures. The median age of patients was 38.0 years. For the primary efficacy variables, Tapentadol NS was non-inferior to Inj/Oral Tramadol in relief of moderate to severe post-operative pain. On the basis of SPID60min, no clinically significant difference was observed between Tapentadol NS and Tramadol IV (1.73±2.24 vs. 1.64± 1.92, -0.09 [95% CI, -0.43, 0.60]). In the co-primary endpoint PGA24hrs, Tapentadol NS was non–inferior to Tramadol IV (2.12 ± 0.707 vs. 2.02 ±0.704, - 0.11[95% CI, -0.07, 0.28). However, on further assessment at 48hr, 72 hrs, and 120hrs, clinically superior pain relief was observed with the Tapentadol NS formulation that was statistically significant (p <0.05) at each of the time intervals. Secondary efficacy measures, including the onset of clinical analgesia and TOTPAR, showed non-inferiority to Tramadol. The safety profile and need for rescue medication were also similar in both the groups during the treatment period. The most common concomitant medications were anti-bacterial (98.3%). Conclusion: Tapentadol NS is a clinically feasible option for improved compliance as induction and maintenance therapy while offering a sustained and persistent patient response that is clinically meaningful in post-surgical settings.

Keywords: tapentadol nasal spray, acute pain, tramadol, post-operative pain

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Authors: Wooseok Byon, Eunyoung Kim, Junseong Kwon, Byung Joo Song, Chan Heun Park

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Background/Purpose: Previous preclinical and clinical data suggest that increased lymphocytic infiltration would be associated with good prognosis and benefit from immunogenic chemotherapy especially in triple-negative breast cancer (TNBC). We investigated a single-center experience of TNBC and relationship with lymphocytic infiltration. Methods: From January 2004 to December 2012, at the Department of Surgery, Kangbuk Samsung Hospital, Sungkyunkwan University, School of Medicine, we retrospectively reviewed 897 breast cancer patients-clinical outcomes, clinicopathological characteristics, breast cancer subtypes. And we reviewed lymphocytic infiltration of TNBC specimens by two pathologists. Statistical analysis of risk factors associated with recurrence was performed. Results: A total of 897 patients, 76 were TNBC (8.47%). Mean age of TNBC patients were 50.95 (SD10.42) years, mean follow-up periods was 40.06 months. We reviewed 49 slides, and there were 8 recurrent breast cancer patients (16.32%), and 4 patients were expired (8.16%). There were 9 lymphocytic predominant breast cancers (LPBC)-carcinomas with either intratumoral lymphocytes in >60% of tumor cell nests. 1 patient of LPBC was recurred and 8 were not. In multivariate logistic regression, the odds ratio of lymphocytic infiltration was 0.59 (p=0.643). Conclusion: In a single-center experience of TNBC, the lymphocytic infiltration in tumor cell nest might be a good trend on the prognosis but there was not statistically significant.

Keywords: tumor-infiltrating lymphocytes, triple negative breast cancer, medical and health sciences

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Authors: Sneha Shankar, Orlando Buendia, Will Evans

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Alpha-1 antitrypsin deficiency (AATD) is a rare, genetic, and multisystemic condition. Underdiagnosis is common, leading to chronic pulmonary and hepatic complications, increased resource utilization, and additional costs to the healthcare system. Currently, there is limited evidence of the direct medical costs of AATD diagnosis in the UK. This study explores the economic impact of AATD patients during the 3 years before diagnosis and to identify the major cost drivers using primary and secondary care electronic health record (EHR) data. The 3 years before diagnosis time period was chosen based on the ability of our tool to identify patients earlier. The AATD algorithm was created using published disease criteria and applied to 148 known AATD patients’ EHR found in a primary care database of 936,148 patients (413,674 Biobank and 501,188 in a single primary care locality). Among 148 patients, 9 patients were flagged earlier by the tool and, on average, could save 3 (1-6) years per patient. We analysed 101 of the 148 AATD patients’ primary care journey and 20 patients’ Hospital Episode Statistics (HES) data, all of whom had at least 3 years of clinical history in their records before diagnosis. The codes related to laboratory tests, clinical visits, referrals, hospitalization days, day case, and inpatient admissions attributable to AATD were examined in this 3-year period before diagnosis. The average cost per patient was calculated, and the direct medical costs were modelled based on the mean prevalence of 100 AATD patients in a 500,000 population. A deterministic sensitivity analysis (DSA) of 20% was performed to determine the major cost drivers. Cost data was obtained from the NHS National tariff 2020/21, National Schedule of NHS Costs 2018/19, PSSRU 2018/19, and private care tariff. The total direct medical cost of one hundred AATD patients three years before diagnosis in primary and secondary care in the UK was £3,556,489, with an average direct cost per patient of £35,565. A vast majority of this total direct cost (95%) was associated with inpatient admissions (£3,378,229). The DSA determined that the costs associated with tier-2 laboratory tests and inpatient admissions were the greatest contributors to direct costs in primary and secondary care, respectively. This retrospective study shows the role of EHRs in calculating direct medical costs and the potential benefit of new technologies for the early identification of patients with AATD to reduce the economic burden in primary and secondary care in the UK.

Keywords: alpha-1 antitrypsin deficiency, costs, digital health, early diagnosis

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Authors: Yong Cang

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RJV001 is a subcutaneous injection containing mutated recombinant Collagenase H (ColH), leading to disruption of collagen matrix in adipose tissue and programmed cell death of adipocytes. Here we reported our clinical investigation of the safety, tolerance and pharmacodynamics of localized RJV001 injection into healthy human abdominal fat tissues (NCT04821648, Arizona Research Center). Investigate the safety, tolerance and clinical pharmacodynamics of subcutaneous RJV001 in humans. In the dose-escalating study, 18 subjects completed the study, 100% female, 78% white, with a mean age of 42[±9.9]. All three tested dose (0.05, 0.075 and 0.15 mg/injection), up to 30 injections, were safe and well-tolerated. Bruising and tenderness to palpation, mild to moderate, were the most frequent local skin reactions but nearly all resolved within 30 days. Additionally, physician-monitored ultrasound measurement showed that a reduction in abdominal fat tissue thickness was consistently observed in Cohort C (0.075, 0.15 mg/injection, 30injections), with a mean reduction of 7.37 [± 2.020] mm. Based on this clinical study, RJV001 has been advanced to phase II clinical studies. In the dose-escalating study, subcutaneously administered RJV001 was safe and well-tolerated in healthy adults up to 0.15 mg/injection, 30 injections. Fat reduction and adipocytolysis were observed by ultrasound measurements and histological analysis for exploratory purposes.

Keywords: fat reduction, mutant collagenase, clinical trial, subcutaneous injection

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Authors: Eashwar V. Somasundaram, Raoul R. Wadhwa, Jacob G. Scott

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The use of radiomics in measuring geometric properties of tumor images such as size, surface area, and volume has been invaluable in assessing cancer diagnosis, treatment, and prognosis. In addition to analyzing geometric properties, radiomics would benefit from measuring topological properties using persistent homology. Intuitively, features uncovered by persistent homology may correlate to tumor structural features. One example is necrotic cavities (corresponding to 2D topological features), which are markers of very aggressive tumors. We develop a data pipeline in R that clusters tumors images based on persistent homology is used to identify meaningful clinical distinctions between tumors and possibly new relationships not captured by established clinical categorizations. A preliminary analysis was performed on 16 Magnetic Resonance Imaging (MRI) breast tissue segments downloaded from the 'Investigation of Serial Studies to Predict Your Therapeutic Response with Imaging and Molecular Analysis' (I-SPY TRIAL or ISPY1) collection in The Cancer Imaging Archive. Each segment represents a patient’s breast tumor prior to treatment. The ISPY1 dataset also provided the estrogen receptor (ER), progesterone receptor (PR), and human epidermal growth factor receptor 2 (HER2) status data. A persistent homology matrix up to 2-dimensional features was calculated for each of the MRI segmentation. Wasserstein distances were then calculated between all pairwise tumor image persistent homology matrices to create a distance matrix for each feature dimension. Since Wasserstein distances were calculated for 0, 1, and 2-dimensional features, three hierarchal clusters were constructed. The adjusted Rand Index was used to see how well the clusters corresponded to the ER/PR/HER2 status of the tumors. Triple-negative cancers (negative status for all three receptors) significantly clustered together in the 2-dimensional features dendrogram (Adjusted Rand Index of .35, p = .031). It is known that having a triple-negative breast tumor is associated with aggressive tumor growth and poor prognosis when compared to non-triple negative breast tumors. The aggressive tumor growth associated with triple-negative tumors may have a unique structure in an MRI segmentation, which persistent homology is able to identify. This preliminary analysis shows promising results in the use of persistent homology on tumor imaging to assess the severity of breast tumors. The next step is to apply this pipeline to other tumor segment images from The Cancer Imaging Archive at different sites such as the lung, kidney, and brain. In addition, whether other clinical parameters, such as overall survival, tumor stage, and tumor genotype data are captured well in persistent homology clusters will be assessed. If analyzing tumor MRI segments using persistent homology consistently identifies clinical relationships, this could enable clinicians to use persistent homology data as a noninvasive way to inform clinical decision making in oncology.

Keywords: cancer biology, oncology, persistent homology, radiomics, topological data analysis, tumor imaging

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Authors: Hossein Ghaedamini, Salman Farahbakhsh, Alireza Amirbeigi, Zahra Saghafi, Salman Daneshi, Alireza Ghaedamini

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Background: Assessing the challenges of clinical education of medical students is one of the most important and sensitive parts of medical education. The aim of this study was to investigate the views and experiences of Kerman medical students on the factors that facilitate and inhibit the quality of clinical education. Materials and Methods: This research was qualitative and used a phenomenological approach. The study population included medical interns of Kerman University of Medical Sciences in 1400. The method of data collection was in-depth interviews with participants. Data were encoded and analyzed by Claizey stepwise model. Results: First, about 540 primary codes were extracted in the form of two main themes (facilitators and inhibitors) and 10 sub-themes including providing motivational models and creating interest in interns, high scientific level of professors and the appropriate quality of their teaching, the use of technology in the clinical education process, delegating authority and freedom of action and more responsibilities to interns, inappropriate treatment of some officials, professors, assistants and department staff with their interns, inadequate educational programming, lack of necessary cooperation and providing inappropriate treatment by clinical training experts for interns, inadequate evaluation method in clinical training for interns, poor quality mornings, the unefficiency of grand rounds, the inappropriate way of evaluating clinical training for interns, the lack of suitable facilities and conditions with the position of a medical intern, and the hardwork of some departments were categorized. Conclusion: Clinical education is always mixed with special principles and subtleties, and special attention to facilitators and inhibitors in this process has an important role in improving its quality.

Keywords: clinical education, medical students, qualitative study, education

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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: Phawida Wattanasoonthorn

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Ventilator-associated pneumonia is a serious infection found to be among the top three infections in the hospital. To investigate the effects of clinical practice guideline on knowledge and preventive practices of nursing personnel, and incidences of ventilator-associated pneumonia. A pre-post quasi-experimental study on 17 professional nurses, and 123 ventilator-associated pneumonia patients admitted to the surgical intensive care unit, and the accident and surgical ward of Songkhla Hospital from October 2013 to January 2014. The study found that after using the clinical practice guideline, the subjects’ median score increased from 16.00 to 19.00. The increase in practicing correctly was from 66.01 percent to 79.03 percent with the statistical significance level of .05, and the incidences of ventilator-associated pneumonia decreased by 5.00 percent. The results of this study revealed that the use of the clinical practice guideline helped increase knowledge and practice skill of nursing personnel, and decrease incidences of ventilator-associated pneumonia. Thus, nursing personnel should be encouraged, reminded and promoted to continue using the practice guideline through various means including training, providing knowledge, giving feedback, and putting up posters to remind them of practicing correctly and sustainably.

Keywords: Clinical Practice Guideline, knowledge, Preventive Ventilator, Pneumonia

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Authors: Changmin Jiang

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In this paper, we build a theoretical model to investigate the relationship between two recent trends in airline frequent-flyer programs (FFPs): the adoption of the “coalition” business model with other commercial partners, and the separation from airlines’ operations. We show that commercial partners benefit from teaming up with FFP, while increasing the number of commercial partners will increase the total profit; it reduces the average profit of the parties involved. Furthermore, we show that the number of commercial partners of an FFP is negatively related with the benefit to keep the FFP in-house.

Keywords: frequent flyer program, coalition, commercial partners, spin-off

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Authors: Getachew Belay Kassahun

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Background: Locally established clinical laboratory reference intervals (RIs) are required to interpret laboratory test results for screening, diagnosis, and prognosis. The objective of this study was to establish a reference interval of clinical chemistry parameters among apparently healthy adolescents aged between 12 and 17 years in Mekelle, Tigrai, in the northern part of Ethiopia. Methods: Community-based cross-sectional study was employed from December 2018 to March 2019 in Mekelle City among 172 males and 172 females based on a Multi-stage sampling technique. Blood samples were tested for Fasting blood sugar (FBS), alanine amino transferase (ALT), aspartate aminotransferase (AST), alkaline phosphatase (ALP), Creatinine, urea, total protein, albumin (ALB), direct and indirect bilirubin (BIL.D and BIL.T) using 25 Bio system clinical chemistry analyzer. Results were analyzed using SPSS version 23 software and based on the Clinical Laboratory Standard Institute (CLSI)/ International Federation of Clinical Chemistry (IFCC) C 28-A3 Guideline which defines the reference interval as the 95% central range of 2.5th and 97.5th percentiles. Mann Whitney U test, descriptive statistics and box and whisker were statistical tools used for analysis. Results: This study observed statistically significant differences between males and females in ALP, ALT, AST, Urea and Creatinine Reference intervals. The established reference intervals for males and females, respectively, were: ALP (U/L) 79.48-492.12 versus 63.56-253.34, ALT (U/L) 4.54-23.69 versus 5.1-20.03, AST 15.7- 39.1 versus 13.3- 28.5, Urea (mg/dL) 9.33-24.99 versus 7.43-23.11, and Creatinine (mg/dL) 0.393-0.957 versus 0.301-0.846. The combined RIs for Total Protein (g/dL) were 6.08-7.85, ALB (g/dL) 4.42-5.46, FBS(mg/dL) 65-110, BIL.D (mg/dL) 0.033-0.532, and BIL.T (mg/dL) 0.106-0.812. Conclusions: The result showed a marked difference between sex and company-derived values for selected clinical chemistry parameters. Thus, the use of age and sex-specific locally established reference intervals for clinical chemistry parameters is recommended.

Keywords: reference interval, adolescent, clinical chemistry, Ethiopia

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Authors: Daphne Alroy-Thiberge

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Trauma-impacted individuals present unique treatment challenges that include high reactivity, hyper-and hypo-arousal, poor adherence to therapy, as well as powerful transference and counter-transference experiences in therapy. This work provides an overview of the clinical tenets most often encountered in trauma-impacted individuals. Further, it provides readily applicable clinical techniques to optimize therapeutic rapport and facilitate accelerated positive mental health outcomes. Finally, integrated neuroscience and clinical evidence-based data are discussed to shed new light on crisis states in trauma-impacted individuals. This knowledge is utilized to provide effective and concrete interventions towards rapid and successful de-escalation of the impacted individual. A highly interactive, adult-learning-principles-based modality is utilized to provide an organic learning experience for participants. The information and techniques learned aim to increase clinical effectiveness, reduce staff injuries and burnout, and significantly enhance positive mental health outcomes and self-determination for the trauma-impacted individuals treated.

Keywords: clinical competencies, crisis interventions, psychotherapy techniques, trauma informed care

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Authors: Alexey Yu. Martynov, Sulejman Bayramov

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Introduction: The myocardial bridging is the most common anomaly of the coronary arteries (CA). Depending on the examination method, the frequency of detected myocardial bridges (MB) varies in a rather wide range. The typical clinical manifestations of MB are angina pectoris, arrhythmias, sudden cardiac death. Objective: To study the incidence of MB in patients hospitalized with coronary artery disease (CAD). To assess clinical manifestations of MB in patients admitted with CAD. Materials and methods: A retrospective analysis of 19159 case histories of patients admitted at clinical city hospital in Moscow from 01.01.2018 to 31.12 2019 with CAD was performed. 9384 patients’ coronary angiographies (CAG) were examined for MB. The localization of MB, the degree of coronary contraction by MB, the number of MB, isolated MB and combined with CAD were assessed. The clinical manifestations of MB were determined. Results: MB was detected in 52 patients all with one myocardial bridge. 20 patients with MB have intact CA, and 32 patients have MB combined with CAD. Among 20 patients with intact CA: I degree of MB contraction (up to 50%) was detected in 9 patients. Clinical manifestations in five cases were angina pectoris, in 3 myocardial infarction (MI) - 1 patients with ST segment elevation MI (STEMI), 2 without ST segment elevation MI (NSTEMI), 1 post-infarction cardiosclerosis (PICS). Stable angina II FC in 3, III FC in 1, vasospastic angina (VSA) in 1 patient. II degree of MB contraction (up to 50-70%) was determined in 9 patients: in seven cases angina pectoris was detected, 1 NSTEMI, 1 PICS. Stable angina II FC in 3, III FC in 1, VSA in 3 patients. III degree of MB contraction (> 70%) detected in 2 patients. II FC stable angina in one case, PICS in another. Among 32 patients having MB combined with CAD I degree of MB contraction was observed in 20 patients. Clinical manifestations in 12 cases were angina pectoris in 8 II FC and in 4 III FC, 7 MI 6 with STEMI and 1 NSTEMI, 1 PICS. II degree of MB contraction was detected in 7 patients, 4 of them had angina pectoris, 3 MI 2 with STEMI and 1 NSTEMI. Stable angina II FC in 3, VSA in 1 patients. III degree of MB contraction was diagnosed in five patients. In two cases, II FC and III FC stable angina were observed, 2 MI with STEMI and NSTEMI, 1 PICS. Conclusions: MB incidence is one in 368 patients with CAD. The most common involvement (68%) is MB combined with CA atherosclerotic lesions. MB with intact CA are detected in one-third (32%) of patients. The first-degree MB contraction is most frequent condition. MI is more often detected in intact CA with first degree MB than in the second degree. The degree of MB contraction was not correlated with the severity of the clinical manifestations.

Keywords: clinical manifestations, coronary angiography, coronary artery disease, myocardial bridging, myocardial infarction, stable angina

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