Search results for: clinical outcomes

Authors: Anupam Sibal

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Whatever is measured tends to improve. With a view to objectively measuring and improving clinical quality across the Apollo Group Hospitals, the initiative of ACE @ 25 (Apollo Clinical Excellence@25) was launched on Jan 09. ACE @ 25 is a clinically balanced scorecard incorporating 25 clinical quality parameters involving complication rates, mortality rates, one-year survival rates and average length of stay after major procedures like liver and renal transplant, CABG, TKR, THR, TURP, PTCA, endoscopy, large bowel resection and MRM covering all major specialties. Also included are hospital acquired infection rates, pain satisfaction and medication errors. Benchmarks have been chosen from the world’s best hospitals. There are weighted scores for outcomes color coded green, orange and red. The cumulative score is 100. Data is reported monthly by 43 Group Hospitals online on the Lighthouse platform. Action taken reports for parameters falling in red are submitted quarterly and reviewed by the board. An audit team audits the data at all locations every six months. Scores are linked to appraisal of the medical head and there is an “ACE @ 25” Champion Award for the highest scorer. Scores for different parameters were variable from green to red at the start of the initiative. Most hospitals showed an improvement in scores over the last four years for parameters where they had showed scores in red or orange at the start of the initiative. The overall scores for the group have shown an increase from 72 in 2010 to 81 in 2015.

Keywords: benchmarks, clinical quality, lighthouse, platform, scores

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Authors: Kamal Kaushik, Trisha, Dandapni, Sambit Nanda, A. Mukherjee, S. Pradhan

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INTRODUCTION: As complexity in radiotherapy practice and processes are increasing, there is a need to assure quality control to a greater extent. At present, no international literature available with regards to the optimal quality control indicators for radiotherapy; moreover, few clinical audits have been conducted in the field of radiotherapy. The primary aim is to improve the processes that directly impact clinical outcomes for patients in terms of patient safety and quality of care. PROCEDURE: A team of an Oncologist, a Medical Physicist and a Radiation Therapist was formed for weekly clinical audits of patient’s undergoing radiotherapy audits The stages for audits include Pre planning audits, Simulation, Planning, Daily QA, Implementation and Execution (with image guidance). Errors in all the parts of the chain were evaluated and recorded for the development of further departmental protocols for radiotherapy. EVALUATION: The errors at various stages of radiotherapy chain were evaluated and recorded for comparison before starting the clinical audits in the department of radiotherapy and after starting the audits. It was also evaluated to find the stage in which maximum errors were recorded. The clinical audits were used to structure standard protocols (in the form of checklist) in department of Radiotherapy, which may lead to further reduce the occurrences of clinical errors in the chain of radiotherapy. RESULTS: The aim of this study is to perform a comparison between number of errors in different part of RT chain in two groups (A- Before Audit and B-After Audit). Group A: 94 pts. (48 males,46 female), Total no. of errors in RT chain:19 (9 needed Resimulation) Group B: 94 pts. (61 males,33 females), Total no. of errors in RT chain: 8 (4 needed Resimulation) CONCLUSION: After systematic periodic clinical audits percentage of error in radiotherapy process reduced more than 50% within 2 months. There is a great need in improving quality control in radiotherapy, and the role of clinical audits can only grow. Although clinical audits are time-consuming and complex undertakings, the potential benefits in terms of identifying and rectifying errors in quality control procedures are potentially enormous. Radiotherapy being a chain of various process. There is always a probability of occurrence of error in any part of the chain which may further propagate in the chain till execution of treatment. Structuring departmental protocols and policies helps in reducing, if not completely eradicating occurrence of such incidents.

Keywords: audit, clinical, radiotherapy, improving functionality

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Authors: Mostafa Najim, Alaa Rahhal, Fadi Khir, Safae Abu Yousef, Amer Aljundi, Feryal Ibrahim, Aliaa Amer, Ahmed Soliman Mohamed, Samira Saleh, Dekra Alfaridi, Ahmed Mahfouz, Sumaya Al-Yafei, Faraj Howady, Mohamad Yahya Khatib, Samar Alemadi

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Background: Coronavirus disease 2019 (COVID-19) increases the risk of coagulopathy among critically ill patients. Although the presence of antiphospholipid antibodies (aPLs) has been proposed as a possible mechanism of COVID-19 induced coagulopathy, their clinical significance among critically ill patients with COVID-19 remains uncertain. Methods: This prospective observational study included patients with COVID-19 admitted to intensive care units (ICU) to evaluate the prevalence and clinical significance of aPLs, including anticardiolipin IgG/IgM, anti-β2-glycoprotein IgG/IgM, and lupus anticoagulant. The study outcomes included the prevalence of aPLs, a primary composite outcome of all-cause mortality, and arterial or venous thrombosis among aPLs positive patients versus aPLs negative patients during their ICU stay. Multiple logistic regression was used to assess the influence of aPLs on the primary composite outcome of mortality and thrombosis. Results: A total of 60 critically ill patients were enrolled. Of whom, 57 (95%) were male, with a mean age of 52.8 ± 12.2 years, and the majority were from Asia (68%). Twenty-two patients (37%) were found to have positive aPLs; of whom 21 patients were positive for lupus anticoagulant, whereas one patient was positive for anti-β2-glycoprotein IgG/IgM. The composite outcome of mortality and thrombosis during ICU did not differ among patients with positive aPLs compared to those with negative aPLs (4 (18%) vs. 6 (16%), aOR= 0.98, 95% CI 0.1-6.7; p-value= 0.986). Likewise, the secondary outcomes, including all-cause mortality, venous thrombosis, arterial thrombosis, discharge from ICU, time to mortality, and time to discharge from ICU, did not differ between those with positive aPLs upon ICU admission in comparison to patients with negative aPLs. Conclusion: The presence of aPLs does not seem to affect the outcomes of critically ill patients with COVID-19 in terms of all-cause mortality and thrombosis. Therefore, clinicians may not screen critically ill patients with COVID-19 for aPLs unless deemed clinically appropriate.

Keywords: antiphospholipid antibodies, critically ill patients, coagulopathy, coronavirus

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Authors: A. Mech

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Repetitive transcranial magnetic stimulation has proven to be a valuable treatment option for patients who have failed to respond to multiple courses of antidepressant medication. In fact, the American Psychiatric Association recommends TMS after one failed treatment course of antidepressant medication. Genetic testing has proven valuable for pharmacokinetic variables, which, if understood, could lead to more efficient dosing of psychotropic medications to improve outcomes. Pharmacodynamic testing can identify biomarkers, which, if addressed, can improve patients' outcomes in antidepressant therapy. Monotherapy treatment of major depressive disorder with methylated B vitamin treatment has been shown to be safe and effective in patients with MTHFR polymorphisms without waiting for multiple trials of failed medication treatment for depression. Such treatment has demonstrated remission rates similar to antidepressant clinical trials. Combining pharmacodynamics testing with repetitive TMS treatment with NeuroStar has shown promising potential for enhancing remission rates and durability of treatment. In this study, a retrospective chart review (ongoing) of patients who obtained repetitive TMS treatment enhanced by dietary supplementation guided by Pharmacodynamic testing, displayed a greater remission rate (90%) than patients treated with only NeuroStar TMS (62%).

Keywords: improved remission rate, major depressive disorder, pharmacodynamic testing, rTMS outcomes

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Authors: Radesh Palakurthi

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The purpose of this study was to determine the impact of experiential learning on learning outcomes in hospitality education. This paper presents the results of an online survey of students from the U.S. studying abroad and their self-reported change in learning outcomes as assessed using the Core Competencies Model for the Hospitality Industry developed by Employment and Training Development Office of the U.S. Department of Labor. The impact of student learning styles on learning outcomes is also evaluated in this study. Kolb’s Learning Styles Inventory Model was used to assess students’ learning style. The results show that students reported significant improvements in their learning outcomes because of engaging in study abroad experiential learning programs. The learning styles of the students had significant effect on one of core learning outcomes- personal effectiveness.

Keywords: hospitality competencies, hospitality education, Kolb’s learning style inventory, learning outcomes, study abroad

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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: Qin-Min Ge, Shu-Ming Pan

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Emergency clinicians usually get teaching qualification after graduating from medical universities without special faculty training in China mainland. Emergency departments are overcrowded places, with large numbers of patients suffering undifferentiated illness. In the field of emergency medicine (EM), improving the faculty competencies and developing the teaching skills are important for medical education, they could enhance learners outcomes and hence affect the patients prognosis indirectly. This article highlights the necessities of faculty training in EM, illustrates the qualities a good clinical educator should qualify, advances the skills as educators in an academic setting and discusses the ways to be good clinical teachers.

Keywords: emergency education, competence, faculty training, teaching, emergency medicine

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Authors: Martina I. Reinhold, Theresa Bacon-Baguley

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Background: Medical knowledge continuously evolves and to help health care providers to stay up-to-date, evidence-based medicine (EBM) has emerged as a model. The practice of EBM requires new skills of the health care provider, including directed literature searches, the critical evaluation of research studies, and the direct application of the findings to patient care. This paper describes the integration and evaluation of an evidence-based medicine course sequence into a Physician Assistant curriculum. This course sequence teaches students to manage and use the best clinical research evidence to competently practice medicine. A survey was developed to assess the outcomes of the EBM course sequence. Methodology: The cornerstone of the three-semester sequence of EBM are interactive small group discussions that are designed to introduce students to the most clinically applicable skills to identify, manage and use the best clinical research evidence to improve the health of their patients. During the three-semester sequence, the students are assigned each semester to participate in small group discussions that are facilitated by faculty with varying background and expertise. Prior to the start of the first EBM course in the winter semester, PA students complete a knowledge-based survey that was developed by the authors to assess the effectiveness of the course series. The survey consists of 53 Likert scale questions that address the nine objectives for the course series. At the end of the three semester course series, the same survey was given to all students in the program and the results from before, and after the sequence of EBM courses are compared. Specific attention is paid to overall performance of students in the nine course objectives. Results: We find that students from the Class of 2016 and 2017 consistently improve (as measured by percent correct responses on the survey tool) after the EBM course series (Class of 2016: Pre- 62% Post- 75%; Class of 2017: Pre- 61 % Post-70%). The biggest increase in knowledge was observed in the areas of finding and evaluating the evidence, with asking concise clinical questions (Class of 2016: Pre- 61% Post- 81%; Class of 2017: Pre- 61 % Post-75%) and searching the medical database (Class of 2016: Pre- 24% Post- 65%; Class of 2017: Pre- 35 % Post-66 %). Questions requiring students to analyze, evaluate and report on the available clinical evidence regarding diagnosis showed improvement, but to a lesser extend (Class of 2016: Pre- 56% Post- 77%; Class of 2017: Pre- 56 % Post-61%). Conclusions: Outcomes identified that students did gain skills which will allow them to apply EBM principles. In addition, the outcomes of the knowledge-based survey allowed the faculty to focus on areas needing improvement, specifically the translation of best evidence into patient care. To address this area, the clinical faculty developed case scenarios that were incorporated into the lecture and discussion sessions, allowing students to better connect the research studies with patient care. Students commented that ‘class discussion and case examples’ contributed most to their learning and that ‘it was helpful to learn how to develop research questions and how to analyze studies and their significance to a potential client’. As evident by the outcomes, the EBM courses achieved the goals of the course and were well received by the students. 

Keywords: evidence-based medicine, clinical education, assessment tool, physician assistant

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Authors: Mohand Yaghi, O. Kehinde

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Background: For the diagnosis of prostate cancer Trans-rectal prostate biopsy (TRPB) is used commonly, the procedure is associated with infective complications. There is evidence that antibiotics (ABx) decrease infective events after TRPB, but different regimens are used. Aim: To systematically review different regimens of prophylactic oral antibiotics in TRPB. Design: Medline, Embase, Clinical trials site, and Cochrane library were searched, experts were consulted about relevant studies. Randomized clinical trials (RCT) conducted in the last twenty years, which investigated different oral antibiotic regimens in TRPB, and compared their efficacy to reduce infectious complications were analyzed. Measurements: Primary outcomes were bacteriuria, urinary tract infection (UTI), fever, bacteremia, sepsis. Secondary outcomes were hospitalization rate, and the prevalence of ABx-resistant bacteria. Results: Nine trials were eligible with 3012 patients. Antibiotics prevented bacteriuria (3.5% vs. 9.88%), UTI (4.46% vs. 9.75%), and hospitalization (0.21% vs. 2.13%) significantly in comparison with placebo or no treatment. No significant difference was found in all outcomes of the review between the single dose regimen and the 3 days. The single dose regimen was as effective as the multiple dose except in Bacteriuria (6.75% vs. 3.25%), and the prevalence of ABx-resistant bacteria (1.57% vs. 0.27%). Quinolones reduced only UTI significantly in comparison with other antibiotics. Lastly, Ciprofloxacin is the best Quinolone to prevent UTI, and hospitalization. Conclusion: it is essential to prescribe prophylactic Antibiotics in TRPB. No conclusive evidence could be claimed about the superiority of the multiple or the 3 days regimens to the single dose regimen. Unexpectedly, ABx-resistant bacteria was identified more often in the single dose cohorts.

Keywords: infection, prostate cancer, sepsis, TRPB

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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: Hee-Young Song

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Background and objectives: In 2011, the Global Initiative for Chronic Obstructive Lung Disease (GOLD) recommendations proposed a multidimensional assessment of patients’ conditions that included both functional parameters and patient-reported outcomes, with the aim to provide a comprehensive assessment of the disease, thus meeting both the needs of the patient and the role of the physician. However, few studies have evaluated patient-reported outcomes as well as objective functional assessments among individuals with chronic obstructive pulmonary disease (COPD) in clinical practice in Korea. This study was undertaken to explore the relationship between functional status assessed by the 6-minute walking distance (MWD) test and subjective health status reported by stable patients with COPD residing in community. Methods: A cross-sectional descriptive study was conducted with 118 stable COPD patients aged 69.4 years old and selected by a convenient sampling from an outpatient department of pulmonology in a tertiaryhospitals. The 6-MWD test was conducted according to standardized instructions. Participants also completed a constructed questionnaire including general characteristics, smoking history, dyspnea by modified medical research council (mMRC) scale, and health status by COPD assessment test (CAT). Anthropometric measurements were performed for body mass index (BMI). Medical records were reviewed to obtain disease-related characteristics including duration of the disease and forced expiratory volume in 1 second (FEV1). Data were analyzed using PASW statistics 20.0. Results: Mean FEV1% of participants was 63.51% and mean 6-MWD and CAT scores were 297.54m and 17.7, respectively. The 6-MWD and CAT showed significant negative correlations (r= -.280, p=.002); FEV1 and CAT did as well correlations (r= -.347, p < .001). Conclusions: Findings suggest that the better functional status an individual with COPD has, the better subjective health status is, and provide the support for using patient-reported outcomes along with functional parameters to facilitate comprehensive assessment of COPD patients in real clinical practices.

Keywords: chronic obstructive pulmonary disease, COPD assessment test, functional status, patient-reported outcomes

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Authors: M. H. Imam, Imran A. Tasadduq, Abdul-Rahim Ahmad, Fahd M. Aldosari

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Learning outcomes of a course (CLOs) and the abilities at the time of graduation referred to as Student Outcomes (SOs) are required to be assessed for ABET accreditation. A question in an assessment must target a CLO as well as an SO and must represent a required level of competence. This paper presents the idea of an Expert System (ES) to select a proper question to satisfy ABET accreditation requirements. For ES implementation, seven attributes of a question are considered including the learning outcomes and Bloom’s Taxonomy level. A database contains all the data about a course including course content topics, course learning outcomes and the CLO-SO relationship matrix. The knowledge base of the presented ES contains a pool of questions each with tags of the specified attributes. Questions and the attributes represent expert opinions. With implicit rule base the inference engine finds the best possible question satisfying the required attributes. It is shown that the novel idea of such an ES can be implemented and applied to a course with success. An application example is presented to demonstrate the working of the proposed ES.

Keywords: expert system, student outcomes, course learning outcomes, question attributes

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Authors: Wan-Ting Kuo, Yi-Wen Liu, Hsiao-Sheng Liu

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Annual incidence of bladder cancer increases in the world and occurs frequently in the male. Most common type is transitional cell carcinoma (TCC) which is treated by transurethral resection followed by intravesical administration of agents. In clinical treatment of bladder cancer, chemotherapeutic drugs-induced apoptosis is always used in patients. However, cancers usually develop resistance to chemotherapeutic drugs and often lead to aggressive tumors with worse clinical outcomes. Approximate 70% TCC recurs and 30% recurrent tumors progress to high-grade invasive tumors, indicating that new therapeutic agents are urgently needed to improve the successful rate of overall treatment. Nonapoptotic program cell death may assist to overcome worse clinical outcomes. Autophagy which is one of the nonapoptotic pathways provides another option for bladder cancer patients. Autophagy is reported as a potent anticancer therapy in some cancers. First of all, we established a mouse orthotopic bladder tumor formation model in order to create a similar tumor microenvironment. IVIS system and micro-ultrasound were utilized to noninvasively monitor tumor formation. In addition, we carried out intravesical treatment in our animal model to be consistent with human clinical treatment. In our study, we carried out intravesical instillation of the autophagy inducer in mouse orthotopic bladder tumor to observe tumor formation by noninvasive IVIS system and micro-ultrasound. Our results showed that bladder tumor formation is suppressed by the autophagy inducer, and there are no significant side effects in the physiology of mice. Furthermore, the autophagy inducer upregulated autophagy in bladder tissues of the treated mice was confirmed by Western blot, immunohistochemistry, and immunofluorescence. In conclusion, we reveal that a novel autophagy inducer with low side effects suppresses bladder tumor formation in our mouse orthotopic bladder tumor model, and it provides another therapeutic approach in bladder cancer patients.

Keywords: bladder cancer, transitional cell carcinoma, orthotopic bladder tumor formation model, autophagy

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Authors: Wenjie Wu, Peng Cheng, Zehua Zhang, Fei Luo, Feng Wu, Min Zhong, Jianzhong Xu

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Background: There has been limited research into the therapeutic efficacy of rapid diagnosis of spinal tuberculosis complicated with pulmonary tuberculosis. We attempted to discover whether the utilization of a DNA microarray assay to detect multidrug-resistant spinal tuberculosis complicated with pulmonary tuberculosis can improve clinical outcomes. Methods: A prospective study was conducted from February 2006 to September 2015. One hundred and forty-three consecutive culture–confirmed, clinically and imaging diagnosed MDR-TB patients with spinal tuberculosis complicated by pulmonary tuberculosis were enrolled into the study. The initial time to treatment for MDR-TB, the method of infection control, radiological indicators of spinal tubercular infectious foci, culture conversion, and adverse drug reactions were compared with the standard culture methods. Results: Of the total of 143 MDR-TB patients, 68 (47.6%) were diagnosed by conventional culture methods and 75 (52.4%) following the implementation of detection using the DNA microarray. Patients in the microarray group began rational use of the second-line drugs schedule more speedily than sufferers in the culture group (17.3 vs. 74.1 days). Among patients were admitted to a general tuberculosis ward, those from the microarray group spent less time in the ward than those from the culture group (7.8 vs. 49.2 days). In those patients with six months follow-up (n=134), patients in the microarray group had a higher rate of sputum negativity conversion at six months (89% vs. 73%). In the microarray group, the rate of drug adverse reactions was significantly lower (22.2% vs. 67.7%). At the same time, they had a more obvious reduction of the area with spinal tuberculous lesions in radiological examinations (77% vs. 108%). Conclusions: The application of the CapitalBio™ DNA Microarray assay caused noteworthy clinical advances including an earlier time to begin MDR-TB treatment, increased sputum culture conversion, improved infection control measures and better radiographical results

Keywords: tuberculosis, multidrug-resistant, tuberculous spondylitis, DNA microarray, clinical outcomes

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Authors: Khaled M. Ali, Ayman A. Mostafa, Soliman M. Soliman

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Objectives: To describe the most common clinical and endoscopic findings associated with complicated corneal ulcers in cats, and to determine the short-term outcomes after surgical treatment of these cats. Animals Eighteen client-owned cats of different breeds (52 females and 28 males), ranging in age from 3 months to 6 years, with corneal ulcers. Procedures: Cats were clinically evaluated to initially determine the concurrent corneal abnormalities. Endoscopic examination was performed to determine the anterior and posterior segments abnormalities. Superficial and deep stromal ulcers were treated using conjunctival flap. Corneal sequestrum was treated by partial keratectomy and conjunctival flap. Anterior synechia was treated via peripheral iridectomy and separation of the adhesion between the iris and the inner cornea. Symblepharon was treated by removal of the adhered conjunctival membrane from the cornea. Incurable endophthalmitis was treated surgically by extirpation. Short-term outcomes after surgical managements of selected corneal abnormalities were then assessed clinically and endoscopically. Results: Deep stromal ulcer with descemetocele, endophthalmitis, symblepharon, corneal sequestration and anterior synechia with secondary glaucoma and corneal scarring were the most common complications of corneal ulcer. FHV-1 was a common etiologic factor of corneal ulceration. Persistent corneal scars of varying shape and size developed in cats with deep stromal ulcer, anterior synechia, and corneal sequestration. Conclusions: Domestic shorthaired and Persian cats were the most predisposed breeds to FHV-1 infection and subsequent corneal ulceration. Immediate management of patients with corneal ulcer would prevent serious complications. No age or sex predisposition to complicated corneal ulceration in cats.

Keywords: cats, complicated corneal ulceration, clinical, endoscopic diagnosis, FHV-1

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Authors: Komathy Thiagarajan, Mohd. Azizuddin Mohd. Yussof, Hasnoorina Husin, Noor Azreena Abd Aziz, Faezah Shekh Abdullah, Abdul Wahaf Abdul Wahid

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Polycystic Ovary Syndrome (PCOS) presents with a plethora of clinical features owing to the multifaceted underlying pathophysiology. This study was conducted to determine the clinical features unique to the sub fertile women attending the Sub fertility Clinic of the National Population and Family Development Board (NPFDB) so that a more holistic approach can be adopted to further enhance the pregnancy outcome in those women. This was a case-control study conducted over a span of three years (from January 2014 until December 2016), whereby women who fulfilled the Rotterdam Criteria 2004 were classified as PCOS (n=79) and women who did not fulfill the Rotterdam Criteria were classified as controls (n=88). The mean age of the women was 30.1 years and the mean duration of marriage was 3.93 years. The majority of women suffered from primary sub fertility (82.6%). The median age was lower among PCOS women (29.0 years) compared to the controls (30.0 years), p<0.05. The majority of PCOS women (43.0%) were obese (BMI > 30 kg/m2) compared to only 19.3% who were obese in the control group, p<0.05. Hypertension was present in 59.5% of PCOS women and only in 36.4% of the control group, p<0.05. There were significantly more women who presented with hirsutism in PCOS group (27.8%) as compared to the control group (5.7%), p<0.05. The findings of this study elucidate that the clinical features of significance among sub fertile women suffering from PCOS, if detected early, are amenable to lifestyle modifications and timely interventions can potentially improve the fertility outcomes in this group of women.

Keywords: clinical features, fertility, lifestyle modification, PCOS

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Authors: Druzhinenko-Silhan Daria, Metz Claire

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In this paper, we introduce the findings of the "Conjugal violence: mothers' parenting and court decisions" (VIC-PADEJ) study, focusing on the motherhood experiences of domestic violence victims. Utilizing a longitudinal research protocol that encompassed clinical interviews, projective methods, and various questionnaires, we detail the outcomes derived from seven clinical interviews with mothers alongside a comprehensive analysis. The findings reveal a pronounced decline in security and an imperative need for structuring both social and internal realities. The convergence of these findings indicates that parenting, post-experiencing domestic violence, may become an unattainable task due to the deficiency of internal resources.

Keywords: domestic violence, parenthood, mothers victims, projective methods, longitudinal research, alceste analysis

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Authors: Abdelfatah Elsenosy, Mahmoud Ebrahim

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Background: Distal radius fractures are commonly encountered in orthopedic practice, especially in elderly patients. A number of clinical papers have supported the idea that anatomic restoration of the distal end of the radius is essential to gain superior results. Aim and objectives: The aim of the study is to systematically review the literature for the management of distal end radius in elderly persons (conservative treatment versus percutaneous wire fixation) as regards radiological and functional outcomes. Subjects and methods: Studies were identified from the Medline, Cochrane, EMBASE, and Google Scholar databases were searched until 2019 using combinations of the following search terms: distal radius fracture, conservative treatment, non-operative treatment, and nonsurgical treatment, surgical treatment, operative, elderly, and older. Reference lists of relevant studies were manually searched. Results: There was no statistical significance difference between CI and PKF groups’ frequency of complication in all of the selected studies. Based on the results, we recommend more analysis regarding every parameter of the radiographic and functional results and specific complications related to each fixation need to be accomplished, which requires more Randomized controlled trials (RCTs) with high quality. Conclusion: Surgical treatment seems to be more effective distal radius fracture compared with conservative treatment when the radiographic outcomes were analyzed, and no significant differences were detected in the functional outcomes and complication rate.

Keywords: radius, fracture, surgical, RCTs, conservative, radiographic, outcomes, orthopedic

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Authors: Kevin Yeo, Christine Hall, Babinchak Tim

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BAT® [Botulism Antitoxin Heptavalent (A,B,C,D,E,F,G)-(Equine)] anti-toxin is a mixture of equine immune globulin fragments indicated for the treatment of symptomatic botulism in adult and pediatric patients. The effectiveness of BAT anti-toxin is based on efficacy studies conducted in animal models. A general explanation of the pivotal animal studies, post market surveillance and outcomes of an observational patient registry for patients treated with BAT product distributed in the USA is briefly discussed. Overall it took 20 animal studies for two well-designed and appropriately powered pivotal efficacy studies – one in which the effectiveness of BAT was assessed against all 7 serotypes in the guinea pig, and the other where efficacy is confirmed in the Rhesus macaque using Serotype A. Clinical Experience for BAT to date involves approximately 600 adult and pediatric patients with suspected botulism. In pre-licensure, patient data was recorded under the US CDC expanded access program (259 adult and pediatric patients between 10 days to 88 years of age). In post licensure, greater than 350 patients to date have received BAT and been followed up by enhanced expanded access program. The analysis of the post market surveillance data provided a unique opportunity to demonstrate clinical benefit in the field study required by the animal rule. While the animal rule is applied because human efficacy studies are not ethical or feasible, a post-marketing requirement is to conduct a study to evaluate safety and clinical benefit when circumstances arise and demonstrate the favourable benefit-risk profile that supported licensure.

Keywords: botulism, threat, clinical benefit, observational patient registry

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Authors: Camille Plant, Katherine McGill, Pek Ang

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Oncology patients face a host of unique challenges, which are physical, psychological and philosophical in nature. This preliminary study aimed to explore the psychiatric morbidity of oncology patients in an outpatient setting at a major public hospital in Australia. The study found that 33 patients were referred to a Psychiatrist by a Clinical Psychologist or treating Oncologist. These patients attended an outpatient Psychiatry appointment at the Calvary Mater Hospital, Newcastle, over a 7 month period (June 2017-January 2018). Of these, 45% went on to have a follow-up appointment. The Clinical Global Impressions Scale (CGI) was used to gather symptom severity scores at baseline and at follow-up. The CGI is a clinician determined instrument that provides an assessment of global functioning. It is comprised of two companion one-item measures: the CGI-Severity (CGI-S) rates mental illness severity, and the CGI-Improvement (CGI-I) rates change in condition or improvement from initiation of treatment. Patients referred to a Psychiatrist were observed to be on average in the Markedly ill approaching Severely ill range (CGI-S average of 5.5). However, those patients who attended a follow-up appointment were on average only Moderately Ill at baseline (CGI-S average of 3.9). Despite these follow patients not being severely mentally ill initially, the contact was helpful, as their CGI-S scores improved on average to the Mildly Ill range (CGI-S average of 2.8). A Mixed ANOVA revealed that there was a significant improvement in mental illness severity post-follow-up appointment (Greenhouse-Geisser .000). There was a near even proportion of males and females attending appointments (58% female), and slightly more females attended a follow-up (60% female). Males were on average more mentally ill at baseline compared to females at baseline (male average M=3.86, female average M=3.56), and males had a greater reduction in mental illness severity on average compared to females (male average M=2.71, female average 3.00). This was approaching significance (.073) and would be important to explore with a larger sample size. Change in clinical condition for follow-up patients was also recorded. It was found that more than half of patients (53%) were observed to experience Minimal improvement in attending at least one follow-up appointment. There was no change for 27% of patients, and there were no patients who were worse at follow up. As this was a preliminary study with small sample size, future research conducted could explore whether there are any significant gender differences, such as whether males experience the significantly greater reduction in symptoms of mental illness compared to females, as well as any effects of cancer stage or type on psychiatric outcomes. Future research could also investigate outcomes for those patients who concurrently access a Clinical Psychologist alongside the Psychiatrist. A limitation of the study is that the outcome measure is a brief item rating completed by the clinician.

Keywords: clinical global impressions scale, psychiatry, morbidity, oncology, outcomes, psychiatry

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Authors: Scott Ashby, Emily Granger, Mark Connellan

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Background: In-hospital management of Out-of-Hospital Cardiac Arrest (OHCA) is complex as the aetiologies are varied. Acute coronary angiography has been shown to improve outcomes for patients with coronary occlusion as the cause; however, these patients are difficult to identify. ECG results may help identify these patients, but the accuracy of this diagnostic test is under debate, and requires further investigation. Methods: Arrest and hospital management information was collated retrospectively for OHCA patients who presented to a single clinical site between 2009 and 2013. Angiography results were then collected and checked for significance with survival to discharge. The presence of a severe lesion (>70%) was then compared to categorised ECG findings, and the accuracy of the test was calculated. Results: 104 patients were included in this study, 44 survived to discharge, 52 died and 8 were transferred to other clinical sites. Angiography appears to significantly correlate with survival to discharge. ECG showed 54.8% sensitivity for detecting the presence of a severe lesion within the group that received angiography. A combined criterion including any ECG pathology showed 100% sensitivity and negative predictive value, however, a low specificity and positive predictive value. Conclusion: In the cohort investigated, ST elevation on ECG is not a sensitive enough screening test to be used to determine whether OHCA patients have coronary stenosis as the likely cause of their arrest, and more investigation into whether screening with a combined ECG criterion, or whether all patients should receive angiography routinely following OHCA is needed.

Keywords: out of hospital cardiac arrest, coronary angiography, resuscitation, emergency medicine

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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: 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: Monika Jurkeviciute, Amia Enam, Johanna Torres Bonilla, Henrik Eriksson

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Introduction: Many evaluations of eHealth interventions conclude that the evidence for improved clinical outcomes is limited, especially when the intervention is short, such as one year. Often, evaluation design does not address the feasibility of achieving clinical outcomes. Evaluations are designed to reflect upon clinical goals of intervention without utilizing the opportunity to illuminate effects on organizations and cost. A comprehensive design of evaluation can better support decision-making regarding the effectiveness and potential transferability of eHealth. Hence, the purpose of this paper is to present a feasible and comprehensive design of evaluation for eHealth intervention, including the design process in different contexts. Methodology: The situation of limited feasibility of clinical outcomes was foreseen in the European Union funded project called “DECI” (“Digital Environment for Cognitive Inclusion”) that is run under the “Horizon 2020” program with an aim to define and test a digital environment platform within corresponding care models that help elderly people live independently. A complex intervention of eHealth implementation into elaborate care models in four different countries was planned for one year. To design the evaluation, a participative approach was undertaken using Pettigrew’s lens of change and transformations, including context, process, and content. Through a series of workshops, observations, interviews, and document analysis, as well as a review of scientific literature, a comprehensive design of evaluation was created. Findings: The findings indicate that in order to get evidence on clinical outcomes, eHealth interventions should last longer than one year. The content of the comprehensive evaluation design includes a collection of qualitative and quantitative methods for data gathering which illuminates non-medical aspects. Furthermore, it contains communication arrangements to discuss the results and continuously improve the evaluation design, as well as procedures for monitoring and improving the data collection during the intervention. The process of the comprehensive evaluation design consists of four stages: (1) analysis of a current state in different contexts, including measurement systems, expectations and profiles of stakeholders, organizational ambitions to change due to eHealth integration, and the organizational capacity to collect data for evaluation; (2) workshop with project partners to discuss the as-is situation in relation to the project goals; (3) development of general and customized sets of relevant performance measures, questionnaires and interview questions; (4) setting up procedures and monitoring systems for the interventions. Lastly, strategies are presented on how challenges can be handled during the design process of evaluation in four different countries. The evaluation design needs to consider contextual factors such as project limitations, and differences between pilot sites in terms of eHealth solutions, patient groups, care models, national and organizational cultures and settings. This implies a need for the flexible approach to evaluation design to enable judgment over the effectiveness and potential for adoption and transferability of eHealth. In summary, this paper provides learning opportunities for future evaluation designs of eHealth interventions in different national and organizational settings.

Keywords: ehealth, elderly, evaluation, intervention, multi-cultural

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Authors: Faran Chaudhry, Anser Daud, Doris Braunstein, Oleg Safir, Allan Gross, Paul Kuzyk

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Background: Acetabular reconstruction in the context of massive acetabular bone loss is challenging. In rare scenarios where the extent of bone loss precludes shell placement (cup-cage), reconstruction at our center consisted of a cage combined with highly porous metal augments. This study evaluates survivorship, complications, and functional outcomes using this technique. Methods: A total of 131 cup-cage implants (129 patients) were included in our retrospective review of revisions of total hip arthroplasty from January 2003 to January 2022. Among these cases, 100/131 (76.3%) were women, the mean age at surgery time was 68.7 years (range, 29.0 to 92.0; SD, 12.4), and the mean follow-up was 7.7 years (range, 0.02 to 20.3; SD, 5.1). Kaplan-Meier survivorship analysis was conducted with failure defined as revision surgery and/or failure of the cup-cage reconstruction. Results: A total of 30 implants (23%) reached the study endpoint involving all-cause revision. Overall survivorship was 74.8% at 10 years and 69.8% at 15 years. Reasons for revision included infection 12/131 (9.1%), dislocation 10/131 (7.6%), aseptic loosening of cup and/or cage 5/131 (3.8%), and aseptic loosening of the femoral stem 2/131 (1.5%). The mean LLD improved from 12.2 ± 15.9 mm to 3.9 ± 11.8 (p<0.05). The horizontal and vertical hip centres on plain film radiographs were significantly improved (p<0.05). Functionally, there was a decrease in the number of patients requiring the use of gait aids, with fewer patients (34, 25.9%) using a cane, walker, or wheelchair post-operatively compared to pre-operatively (58, 44%). There was a significant increase in the number of independent ambulators from 24 to 47 (36%). Conclusion: The cup-cage construct is a reliable treatment option for the treatment of various acetabular defects. There are favourable survivorship, clinical and radiographic outcomes, with a satisfactory complication rate.

Keywords: revision total hip arthroplasty, acetabular defect, pelvic discontinuity, trabecular metal augment, cup-cage

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Authors: Le-Quyen Nguyen, Hoang Van Bui, Ngoc Thi Tran, Binh Thanh Le, Linus Olson, Thanh Quang Le

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Objective: We compared of outcomes between infected and non-infected COVID-19 pregnant at the largest obstetrics and gynecology hospital in southern Vietnam. Materials and Methods: A retrospective study was conducted at gestational age (GA) 28-42 weeks, who terminated pregnancy and had a real-time PCR test for SARS-CoV-2 at Tu Du Hospital. Demographic, clinical, laboratory, and epidemiological data were collected from hospital electronic-medical-records. Diagnosis and screening of SARS-CoV-2 used Real-time-PCR. Results: From July to October 2021, 9,246 pregnant with GA of 28-42 weeks were delivered, including 664 infected with COVID-19 and 8,582 non-infected. The cesarean section (CS) rates of pregnant with and without COVID-19 were 47.3% and 46.0%. At GA 32-34 weeks, the rate of CS with COVID-19 was 5.07 times higher than without. The rate of postpartum hemorrhage (PPH) and the Apgar score between these two groups were similar. The mortality rate of infected pregnants was 2.26%. Conclusions: COVID-19 infection increased the CS rate in the group of preterm pregnancies from 32 to less than 34 weeks. COVID-19 did not increase the risk of complications related to adverse pregnancy outcomes such as PPH, Apgar scores, the ratio of stillbirths, deaths due to malformation, and fetal deaths in labor.

Keywords: COVID-19, SARS-CoV-2, pregnancy, outcome, vietnam

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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: Elena K. Schneider, Johnny X. Huang, Vincenzo Carbone, Mark Baker, Mohammad A. K. Azad, Matthew A. Cooper, Jian Li, Tony Velkov

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Ivacaftor is a novel CF trans-membrane conductance regulator (CFTR) potentiator that improves the pulmonary function for cystic fibrosis patients bearing a G551D CFTR-protein mutation. Because ivacaftor is highly bound (>97%) to plasma proteins, there is the strong possibility that co-administered CF drugs that compete for the same plasma protein binding sites and impact the free drug concentration. This in turn could lead to drastic changes in the in vivo efficacy of ivacaftor and therapeutic outcomes. This study compares the binding affinity of ivacaftor and co-administered CF drugs for human serum albumin (HSA) and α1-acid glycoprotein (AGP) using surface plasmon resonance and fluorimetric binding assays that measure the displacement of site selective probes. Due to their high plasma protein binding affinities, drug-drug interactions between ivacaftor are to be expected with ducosate, montelukast, ibuprofen, dicloxacillin, omeprazole and loratadine. The significance of these drug-drug interactions is interpreted in terms of the pharmacodynamic/pharmacokinetic parameters and molecular docking simulations. The translational outcomes of the data are presented as recommendations for a staggered treatment regimen for future clinical trials which aims to maximize the effective free drug concentration and clinical efficacy of ivacaftor.

Keywords: human α-1-acid glycoprotein, binding affinity, human serum albumin, ivacaftor, cystic fibrosis

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Authors: Susan Lewis

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The assessment of learning outcomes at the program level has attracted much international interest from the perspectives of quality assurance and ongoing curricular redesign and renewal. This paper examines program-level learning outcomes in the field of music and technology, an area of study that has seen an explosion in program development over the past fifteen years. The Audio Engineering Society (AES) maintains an online directory of educational institutions worldwide, yielding the most comprehensive inventory of programs and courses in music and technology. The inventory includes courses, programs, and degrees in music and technology, music and computer science, music production, and the music industry. This paper focuses on published student learning outcomes for undergraduate degrees in music and technology and analyses commonalities at institutions in North America, the United Kingdom, and Europe. The results of a survey of student learning outcomes at twenty institutions indicates a focus on three distinct student learning outcomes: (1) cross-disciplinary knowledge in the fields of music and technology; (2) the practical application of training through the professional industry; and (3) the acquisition of skills in communication and collaboration. The paper then analyses assessment mechanisms for tracking student learning and achievement of learning outcomes at these institutions. The results indicate highly variable assessment practices. Conclusions offer recommendations for enhancing assessment techniques and better communicating learning outcomes to students.

Keywords: quality assurance, student learning; learning outcomes, music and technology

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Authors: Hwang Kwon

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

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

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