Search results for: clinical and patient outcomes
Commenced in January 2007
Frequency: Monthly
Edition: International
Paper Count: 8220

Search results for: clinical and patient outcomes

7800 The Association of Cone-Shaped Epiphysis and Poland Syndrome: A Case Report

Authors: Mohammad Alqattan, Tala Alkhunani, Reema Al, Aldawish, Felwa Almurshard, Abdullah Alzahrani

Abstract:

: Poland’s Syndrome is a congenital anomaly with two clinical features : unilateral agenesis of the pectoralis major and ipsilateral hand symbrachydactyly. Case presentation: We report a rare case of bilateral Poland’s syndrome with several unique features. Discussion: Poland’s syndrome is thought to be due to a vascular insult to the subclavian axis around the 6th week of gestation. Our patient has multiple rare and unique features of Poland’s syndrome. Conclusion: To our best knowledge, for the first time in the literature we associate Poland’s syndrome with cone-shaped epiphysis of the metacarpals of all fingers. Bilaterality, cleft hand deformity, and dextrocardia, were also rare features in our patient.

Keywords: Poland's syndrome, cleft hand deformity, bilaterality, dextrocardia, cone-shaped epiphysis

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7799 Reverse Twin Block with Expansion Screw for Treatment of Skeletal Class III Malocclusion in Growing Patient: Case Report

Authors: Alfrina Marwan, Erna Sulistyawati

Abstract:

Class III malocclusion shows both skeletal and dentoalveolar component. Sketal Class III malocclusion can have variants in different region, maxilla or mandibular. Skeletal Class III malocclusion during growth period is considered to treat to prevent its severity in adulthood. Orthopedics treatment of skeletal Class III malocclusion in growing patient can be treated by using reverse twin block with expansion screw to modify the growth pattern. The objective of this case report was to describe the functional correction of skeletal Class III maloclussion using reverse twin block with expansion screw in growing patient. A patient with concave profile came with a chief complaint of aesthetic problems. The cephalometric analysis showed that patient had skeletal Class III malocclusion (ANB -50, SNA 75º, Wits appraisal -3 mm) with anterior cross bite and deep bite (overjet -3 mm, overbite 6 mm). In this case report, the patient was treated with reverse twin block appliance with expansion screw. After three months of treatment, the skeletal problems have been corrected (ANB -1°), overjet, overbite and aesthetic were improved. Reverse twin block appliance with expansion screw can be used as orthopedics treatment for skeletal Class III malocclusion in growing patient and can improve the aesthetic with great satisfaction which was the main complaint in this patient.

Keywords: maxilla retrognatism, reverse twin block, skeletal class III malocclusion, growing patient

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7798 Quantifying Impairments in Whiplash-Associated Disorders and Association with Patient-Reported Outcomes

Authors: Harpa Ragnarsdóttir, Magnús Kjartan Gíslason, Kristín Briem, Guðný Lilja Oddsdóttir

Abstract:

Introduction: Whiplash-Associated Disorder (WAD) is a health problem characterized by motor, neurological and psychosocial symptoms, stressing the need for a multimodal treatment approach. To achieve individualized multimodal approach, prognostic factors need to be identified early using validated patient-reported and objective outcome measures. The aim of this study is to demonstrate the degree of association between patient-reported and clinical outcome measures of WAD patients in the subacute phase. Methods: Individuals (n=41) with subacute (≥1, ≤3 months) WAD (I-II), medium to high-risk symptoms, or neck pain rating ≥ 4/10 on the Visual Analog Scale (VAS) were examined. Outcome measures included measurements for movement control (Butterfly test) and cervical active range of motion (cAROM) using the NeckSmart system, a computer system using an inertial measurement unit (IMU) that connects to a computer. The IMU sensor is placed on the participant’s head, who receives visual feedback about the movement of the head. Patient-reported neck disability, pain intensity, general health, self-perceived handicap, central sensitization, and difficulties due to dizziness were measured using questionnaires. Excel and R statistical software were used for statistical analyses. Results: Forty-one participants, 15 males (37%), 26 females (63%), mean (SD) age 36.8 (±12.7), underwent data collection. Mean amplitude accuracy (AA) (SD) in the Butterfly test for easy, medium, and difficult paths were 2.4mm (0.9), 4.4mm (1.8), and 6.8mm (2.7), respectively. Mean cAROM (SD) for flexion, extension, left-, and right rotation were 46.3° (18.5), 48.8° (17.8), 58.2° (14.3), and 58.9° (15.0), respectively. Mean scores on the Neck Disability Index (NDI), VAS, Dizziness Handicap Inventory (DHI), Central Sensitization Inventory (CSI), and 36-Item Short Form Survey RAND version (RAND) were 43% (17.4), 7 (1.7), 37 (25.4), 51 (17.5), and 39.2 (17.7) respectively. Females showed significantly greater deviation for AA compared to males for easy and medium Butterfly paths (p<0.05). Statistically significant moderate to strong positive correlation was found between the DHI and easy (r=0.6, p=0.05), medium (r=0.5, p=0.05)) and difficult (r=0.5, p<0.05) Butterfly paths, between the total RAND score and all cAROMs (r between 0.4-0.7, p≤0.05) except flexion (r=0.4, p=0.7), and between the NDI score and CSI (r=0.7, p<0.01), VAS (r=0.5, p<0.01), and DHI (r=0.7, p<0.01) scores respectively. Discussion: All patient-reported and objective measures were found to be outside the reference range. Results suggest females have worse movement control in the neck in the subacute WAD phase. However, no statistical difference based on gender was found in patient-reported measures. Suggesting females might have worse movement control than males in general in this phase. The correlation found between DHI and the Butterfly test can be explained because the DHI measures proprioceptive symptoms like dizziness and eye movement disorders that can affect the outcome of movement control tests. A correlation was found between the total RAND score and cAROM, suggesting that a reduced range of motion affects the quality of life. Significance: The NeckSmart system can detect abnormalities in cAROM, fine movement control, and kinesthesia of the neck. Results suggest females have worse movement control than males. Results show a moderate to a high correlation between several patient-reported and objective measurements.

Keywords: whiplash associated disorders, car-collision, neck, trauma, subacute

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7797 Early Detection of Neuropathy in Leprosy-Comparing Clinical Tests with Nerve Conduction Study

Authors: Suchana Marahatta, Sabina Bhattarai, Bishnu Hari Paudel, Dilip Thakur

Abstract:

Background: Every year thousands of patients develop nerve damage and disabilities as a result of leprosy which can be prevented by early detection and treatment. So, early detection and treatment of nerve function impairment is of paramount importance in leprosy. Objectives: To assess the electrophysiological pattern of the peripheral nerves in leprosy patients and to compare it with clinical assessment tools. Materials and Methods: In this comparative cross-sectional study, 74 newly diagnosed leprosy patients without reaction were enrolled. They underwent thorough evaluation for peripheral nerve function impairment using clinical tests [i.e. nerve palpation (NP), monofilament (MF) testing, voluntary muscle testing (VMT)] and nerve conduction study (NCS). Clinical findings were compared with that of NCS using SPSS version 11.5. Results: NCS was impaired in 43.24% of leprosy patient at the baseline. Among them, sensory NCS was impaired in more patients (32.4%) in comparison to motor NCS (20.3%). NP, MF, and VMT were impaired in 58.1%, 25.7%, and 9.4% of the patients, respectively. Maximum concordance of monofilament testing and sensory NCS was found for sural nerve (14.7%). Likewise, the concordance of motor NP and motor NCS was the maximum for ulnar nerve (14.9%). When individual parameters of the NCS were considered, amplitude was found to be the most frequently affected parameter for both sensory and motor NCS. It was impaired in 100% of cases with abnormal NCS findings. Conclusion: Since there was no acceptable concordance between NCS findings and clinical findings, we should consider NCS whenever feasible for early detection of neuropathy in leprosy. The amplitude of both sensory nerve action potential (SNAP) and compound nerve action potential (CAMP) could be important determinants of the abnormal NCS if supported by further studies.

Keywords: leprosy, nerve function impairment, neuropathy, nerve conduction study

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7796 Drug-Drug Plasma Protein Binding Interactions of Ivacaftor

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

Abstract:

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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7795 Parents, Carers and Young Persons’ Views Regarding Nursing ‘Workarounds’ Within Clinical Electronic Patient Record Systems

Authors: Patrick Nurse, Professor Neil Sebire, Polly Livermore

Abstract:

The use of digital systems in healthcare is now highly prevalent. With further advancement of technology, these systems will become increasingly utilised within the healthcare sector. Therefore understanding how clinicians (for example, doctors, nurses) interact with technology and digital systems is critical to making care safer. Seven members from the Parent/Carers’ Research Advisory Group and the Young-Persons’ Research Group at a healthcare Trust in London and three staff members contributed to an engagement workshop to assess the impact of digital systems on the practice of nurses. The group also advised on the viability of a research study to investigate this further. A wide range of issues within digital system implementation in healthcare were raised, such as ‘workarounds’, system’s training, and upkeep and regulation of usage, which all emerged as early themes during the discussion. Further discussion focused on the subject of escalation of issues, ‘workarounds’, and problem solving. While challenging to implement, digital systems are hugely beneficial to healthcare providers. The workshop indicated that there is scope for investigation of the prevalence, nature, and escalation of ‘workarounds’, this was of key interest to the advisory group. An interesting concern of the group was their worry from a patient and parental perspective regarding how nurses might feel when needing to complete a ‘workaround’ during a busy shift. This is especially relevant if the reasons to complete the ‘workaround’ were outside the nurse’s control, driven by clinical need and urgency of care. This showed the level of insight that those using healthcare services have into the reality of workflows of those providing care. Additionally, it reflects the desire for patients and families to understand more about the administration and methodology of their care. Future study should be dedicated to understanding why nurses deploy ‘workarounds’, as well as their perspective and experience of them and subsequent escalation through leadership hierarchies

Keywords: patient engagement/involvement, workarounds, medication-administration, digital systems

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7794 Policy to Improve in vitro Fertilization Outcome in Women with Poor Ovarian Response: Frozen Embryo Transfer (ET) of Accumulated Vitrified Embryos vs. Frozen ET of Accumulated Vitrified Embryos plus Fresh ET

Authors: Hwang Kwon

Abstract:

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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7793 Telemedicine Versus Face-to-Face Follow up in General Surgery: A Randomized Controlled Trial

Authors: Teagan Fink, Lynn Chong, Michael Hii, Brett Knowles

Abstract:

Background: Telemedicine is a rapidly advancing field providing healthcare to patients at a distance from their treating clinician. There is a paucity of high-quality evidence detailing the safety and acceptability of telemedicine for postoperative outpatient follow-up. This randomized controlled trial – conducted prior to the COVID 19 pandemic – aimed to assess patient satisfaction and safety (as determined by readmission, reoperation and complication rates) of telephone compared to face-to-face clinic follow-up after uncomplicated general surgical procedures. Methods: Patients following uncomplicated laparoscopic appendicectomy or cholecystectomy and laparoscopic or open umbilical or inguinal hernia repairs were randomized to a telephone or face-to-face outpatient clinic follow-up. Data points including patient demographics, perioperative details and postoperative outcomes (eg. wound healing complications, pain scores, unplanned readmission to hospital and return to daily activities) were compared between groups. Patients also completed a Likert patient satisfaction survey following their consultation. Results: 103 patients were recruited over a 12-month period (21 laparoscopic appendicectomies, 65 laparoscopic cholecystectomies, nine open umbilical hernia repairs, six laparoscopic inguinal hernia repairs and two laparoscopic umbilical hernia repairs). Baseline patient demographics and operative interventions were the same in both groups. Patient or clinician-reported concerns on postoperative pain, use of analgesia, wound healing complications and return to daily activities at clinic follow-up were not significantly different between the two groups. Of the 58 patients randomized to the telemedicine arm, 40% reported high and 60% reported very high patient satisfaction. Telemedicine clinic mean consultation times were significantly shorter than face-to-face consultation times (telemedicine 10.3 +/- 7.2 minutes, face-to-face 19.2 +/- 23.8 minutes, p-value = 0.014). Rates of failing to attend clinic were not significantly different (telemedicine 3%, control 6%). There was no increased rate of postoperative complications in patients followed up by telemedicine compared to in-person. There were no unplanned readmissions, return to theatre, or mortalities in this study. Conclusion: Telemedicine follow-up of patients undergoing uncomplicated general surgery is safe and does not result in any missed diagnosis or higher rates of complications. Telemedicine provides high patient satisfaction and steps to implement this modality in inpatient care should be undertaken.

Keywords: general surgery, telemedicine, patient satisfaction, patient safety

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7792 Calculating Ventricle’s Area Based on Clinical Dementia Rating Values on Coronal MRI Image

Authors: Retno Supriyanti, Ays Rahmadian Subhi, Yogi Ramadhani, Haris B. Widodo

Abstract:

Alzheimer is one type of disease in the elderly that may occur in the world. The severity of the Alzheimer can be measured using a scale called Clinical Dementia Rating (CDR) based on a doctor's diagnosis of the patient's condition. Currently, diagnosis of Alzheimer often uses MRI machine, to know the condition of part of the brain called Hippocampus and Ventricle. MRI image itself consists of 3 slices, namely Coronal, Sagittal and Axial. In this paper, we discussed the measurement of the area of the ventricle especially in the Coronal slice based on the severity level referring to the CDR value. We use Active Contour method to segment the ventricle’s region, therefore that ventricle’s area can be calculated automatically. The results show that this method can be used for further development in the automatic diagnosis of Alzheimer.

Keywords: Alzheimer, CDR, coronal, ventricle, active contour

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7791 Social Justice-Focused Mental Health Practice: An Integrative Model for Clinical Social Work

Authors: Hye-Kyung Kang

Abstract:

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

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

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7790 The Impact of Streptococcus pneumoniae Colonization on Viral Bronchiolitis

Authors: K. Genise, S. Murthy

Abstract:

Introductory Statement: The results of this retrospective chart review suggest the effects of bacterial colonization in critically ill children with viral bronchiolitis, currently unproven, are clinically insignificant. Background: Viral bronchiolitis is one of the most prevalent causes of illness requiring hospitalization among children worldwide and one of the most common reasons for admission to pediatric intensive care. It has been hypothesized that co-infection with bacteria results in more severe clinical outcomes. Conversely, the effects of bacterial colonization in critically ill patients with bronchiolitis are poorly defined. Current clinical management of colonized patients consists primarily of supportive therapies with the role of antibiotics remaining controversial. Methods: A retrospective review of all critically ill children admitted to the BC Children’s Hospital Pediatric Intensive Care Unit (PICU) from 2014-2017 with a diagnosis of bronchiolitis was performed. Routine testing in this time frame consisted of complete pathogen testing, including PCR for Streptococcus pneumoniae. Analyses were performed to determine the impact of bacterial colonization and antibiotic use on a primary outcome of PICU length-of-stay, with secondary outcomes of hospital length-of-stay and duration of ventilation. Results: There were 92 patients with complete pathogen testing performed during the assessed timeframe. A comparison between children with detected Streptococcus pneumoniae (n=22) and those without (n=70) revealed no significant (p=0.20) differences in severity of illness on presentation as per Pediatric Risk of Mortality III scores (mean=3.0). Patients colonized with S. pneumoniae had significantly shorter PICU stays (p=0.002), hospital stays (p=0.0001) and duration of non-invasive ventilation (p=0.002). Multivariate analyses revealed that these effects on length of PICU stay and duration of ventilation do not persist after controlling for antibiotic use, presence of radiographic consolidation, age, and severity of illness (p=0.15, p=0.32). The relationship between colonization and duration of hospital stay persists after controlling for these variables (p=0.008). Conclusions: Children with viral bronchiolitis colonized with S. pneumoniae do not appear to have significantly different PICU length-of-stays or duration of ventilation compared to children who are not colonized. Colonized children appear to have shorter hospital stays. The results of this study suggest bacterial colonization is not associated with increased severity of presenting illness or negative clinical outcomes.

Keywords: bronchiolitis, colonization, critical care, pediatrics, pneumococcal, infection

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7789 Program Level Learning Outcomes in Music and Technology: Toward Improved Assessment and Better Communication

Authors: Susan Lewis

Abstract:

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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7788 Corticomotor Excitability after Two Different Repetitive Transcranial Magnetic Stimulation Protocols in Ischemic Stroke Patients

Authors: Asrarul Fikri Abu Hassan, Muhammad Hafiz bin Hanafi, Jafri Malin Abdullah

Abstract:

This study is to compare the motor evoked potential (MEP) changes using different settings of repetitive transcranial magnetic stimulation (rTMS) in the post-haemorrhagic stroke patient which treated conservatively. The goal of the study is to determine changes in corticomotor excitability and functional outcome after repetitive transcranial magnetic stimulation (rTMS) therapy regime. 20 post-stroke patients with upper limb hemiparesis were studied due to haemorrhagic stroke. One of the three settings; (I) Inhibitory setting, or (II) facilitatory setting, or (III) control group, no excitatory or inhibitory setting have been applied randomly during the first meeting. The motor evoked potential (MEP) were recorded before and after application of the rTMS setting. Functional outcomes were evaluated using the Barthel index score. We found pre-treatment MEP values of the lesional side were lower compared to post-treatment values in both settings. In contrast, we found that the pre-treatment MEP values of the non-lesional side were higher compared to post-treatment values in both settings. Interestingly, patients with treatment, either facilitatory setting and inhibitory setting have faster motor recovery compared to the control group. Our data showed both settings might improve the MEP of the upper extremity and functional outcomes in the haemorrhagic stroke patient.

Keywords: Barthel index, corticomotor excitability, motor evoked potential, repetitive transcranial magnetic stimulation, stroke

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7787 A Case Study on Experiences of Clinical Preceptors in the Undergraduate Nursing Program

Authors: Jacqueline M. Dias, Amina A Khowaja

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

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

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7786 The Recommended Summary Plan for Emergency Care and Treatment (ReSPECT) Process: An Audit of Its Utilisation on a UK Tertiary Specialist Intensive Care Unit

Authors: Gokulan Vethanayakam, Daniel Aston

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Introduction: The ReSPECT process supports healthcare professionals when making patient-centered decisions in the event of an emergency. It has been widely adopted by the NHS in England and allows patients to express thoughts and wishes about treatments and outcomes that they consider acceptable. It includes (but is not limited to) cardiopulmonary resuscitation decisions. ReSPECT conversations should ideally occur prior to ICU admission and should be documented in the eight sections of the nationally-standardised ReSPECT form. This audit evaluated the use of ReSPECT on a busy cardiothoracic ICU in an NHS Trust where established policies advocating its use exist. Methods: This audit was a retrospective review of ReSPECT forms for a sample of high-risk patients admitted to ICU at the Royal Papworth Hospital between January 2021 and March 2022. Patients all received one of the following interventions: Veno-Venous Extra-Corporeal Membrane Oxygenation (VV-ECMO) for severe respiratory failure (retrieved via the national ECMO service); cardiac or pulmonary transplantation-related surgical procedures (including organ transplants and Ventricular Assist Device (VAD) implantation); or elective non-transplant cardiac surgery. The quality of documentation on ReSPECT forms was evaluated using national standards and a graded ranking tool devised by the authors which was used to assess narrative aspects of the forms. Quality was ranked as A (excellent) to D (poor). Results: Of 230 patients (74 VV-ECMO, 104 transplant, 52 elective non-transplant surgery), 43 (18.7%) had a ReSPECT form and only one (0.43%) patient had a ReSPECT form completed prior to ICU admission. Of the 43 forms completed, 38 (88.4%) were completed due to the commencement of End of Life (EoL) care. No non-transplant surgical patients included in the audit had a ReSPECT form. There was documentation of balance of care (section 4a), CPR status (section 4c), capacity assessment (section 5), and patient involvement in completing the form (section 6a) on all 43 forms. Of the 34 patients assessed as lacking capacity to make decisions, only 22 (64.7%) had reasons documented. Other sections were variably completed; 29 (67.4%) forms had relevant background information included to a good standard (section 2a). Clinical guidance for the patient (section 4b) was given in 25 (58.1%), of which 11 stated the rationale that underpinned it. Seven forms (16.3%) contained information in an inappropriate section. In a comparison of ReSPECT forms completed ahead of an EoL trigger with those completed when EoL care began, there was a higher number of entries in section 3 (considering patient’s values/fears) that were assessed at grades A-B in the former group (p = 0.014), suggesting higher quality. Similarly, forms from the transplant group contained higher quality information in section 3 than those from the VV-ECMO group (p = 0.0005). Conclusions: Utilisation of the ReSPECT process in high-risk patients is yet to be well-adopted in this trust. Teams who meet patients before hospital admission for transplant or high-risk surgery should be encouraged to engage with the ReSPECT process at this point in the patient's journey. VV-ECMO retrieval teams should consider ReSPECT conversations with patients’ relatives at the time of retrieval.

Keywords: audit, critical care, end of life, ICU, ReSPECT, resuscitation

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7785 Impact of Serum Estrogen and Progesterone Levels in the Outcome Pregnancy Rate in Frozen Embryo Transfer Cycles. A Prospective Cohort Study

Authors: Sayantika Biswas, Dipanshu Sur, Amitoj Athwal, Ratnabali Chakravorty

Abstract:

Title: Impact of serum estrogen and progesterone levels in the outcome pregnancy rate in frozen embryo transfer cycles. A prospective cohort study Objective: The aim of the current study was to evaluate the effect of serum estradiol (E2) and progesterone (P4) levels at different time points on pregnancy outcomes in frozen embryo transfer (FET) cycles. Materials & Method: A prospective cohort study was performed in patients undergoing frozen embryo transfer. Patients under age 37 years of age with at least one good blastocyst or three good day 3 embryos were included in the study. For endometrial preparation, 14 days of oral estradiol use (2X2 mg for 5 days. 3X2 mg for 4 days, and 4X2 mg for 5 days) was followed by vaginal progesterone twice a day and 50 mg intramuscular progesterone twice a day. Embryo transfer was scheduled 72-76 hrs or 116-120hrs after the initiation of progesterone. Serum E2 and P4 levels were examined at 4 times a) at the start of the menstrual cycle prior to the hormone supplementation. b) on the day of P4 start. c) on the day of ET. d) on the third day after ET. Result: A total 41 women were included in this study (mean age 31.8; SD 2.8). Clinical pregnancy rate was 65.55%. Serum E2 levels on at the start of the menstrual cycle prior to the hormone supplementation and on the day of P4 start were high in patients who achieved pregnancy compared to who did not (P=0.005 and P=0.019 respectively). P4 levels on on the day of ET were also high in patients with clinical pregnancy. On the day of P4 start, a serum E2 threshold of 186.4 pg/ml had a sensitivity of 82%, and P4 had a sensitivity of 71% for the prediction of clinical pregnancy at the threshold value 16.00 ng/ml. Conclusion: In women undergoing FET with hormone replacement, serum E2 level >186.4 pg/ml on the day of the start of progesterone and serum P4 levels >16.00 ng/ml on embryo transfer day are associated with clinical pregnancy.

Keywords: serum estradiol, serum progesterone, clinical pregnancy, frozen embryo transfer

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7784 Predicting Provider Service Time in Outpatient Clinics Using Artificial Intelligence-Based Models

Authors: Haya Salah, Srinivas Sharan

Abstract:

Healthcare facilities use appointment systems to schedule their appointments and to manage access to their medical services. With the growing demand for outpatient care, it is now imperative to manage physician's time effectively. However, high variation in consultation duration affects the clinical scheduler's ability to estimate the appointment duration and allocate provider time appropriately. Underestimating consultation times can lead to physician's burnout, misdiagnosis, and patient dissatisfaction. On the other hand, appointment durations that are longer than required lead to doctor idle time and fewer patient visits. Therefore, a good estimation of consultation duration has the potential to improve timely access to care, resource utilization, quality of care, and patient satisfaction. Although the literature on factors influencing consultation length abound, little work has done to predict it using based data-driven approaches. Therefore, this study aims to predict consultation duration using supervised machine learning algorithms (ML), which predicts an outcome variable (e.g., consultation) based on potential features that influence the outcome. In particular, ML algorithms learn from a historical dataset without explicitly being programmed and uncover the relationship between the features and outcome variable. A subset of the data used in this study has been obtained from the electronic medical records (EMR) of four different outpatient clinics located in central Pennsylvania, USA. Also, publicly available information on doctor's characteristics such as gender and experience has been extracted from online sources. This research develops three popular ML algorithms (deep learning, random forest, gradient boosting machine) to predict the treatment time required for a patient and conducts a comparative analysis of these algorithms with respect to predictive performance. The findings of this study indicate that ML algorithms have the potential to predict the provider service time with superior accuracy. While the current approach of experience-based appointment duration estimation adopted by the clinic resulted in a mean absolute percentage error of 25.8%, the Deep learning algorithm developed in this study yielded the best performance with a MAPE of 12.24%, followed by gradient boosting machine (13.26%) and random forests (14.71%). Besides, this research also identified the critical variables affecting consultation duration to be patient type (new vs. established), doctor's experience, zip code, appointment day, and doctor's specialty. Moreover, several practical insights are obtained based on the comparative analysis of the ML algorithms. The machine learning approach presented in this study can serve as a decision support tool and could be integrated into the appointment system for effectively managing patient scheduling.

Keywords: clinical decision support system, machine learning algorithms, patient scheduling, prediction models, provider service time

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7783 Prosthesis Design for Bilateral Hip Disarticulation Management

Authors: Mauricio Plaza, Willian Aperador

Abstract:

Hip disarticulation is an amputation through the hip joint capsule, removing the entire lower extremity, with a closure of the remaining musculature over the exposed acetabulum. Tumors of the distal and proximal femur were treated by total femur resection; a hip disarticulation sometimes is a performance for massive trauma with crush injuries to the lower extremity. This article discusses the design a system for rehabilitation of a patient with bilateral hip disarticulations. The prosthetics designed allowed the patient to do natural gait suspended between parallel articulate crutches with the body weight support between the crutches. The care of this patient was a challenge due to bilateral amputations at such a high level and the special needs of a patient mobility.

Keywords: amputation, prosthesis, mobility, hemipelvectomy

Procedia PDF Downloads 402
7782 Electronic Six-Minute Walk Test (E-6MWT): Less Manpower, Higher Efficiency, and Better Data Management

Authors: C. M. Choi, H. C. Tsang, W. K. Fong, Y. K. Cheng, T. K. Chui, L. Y. Chan, K. W. Lee, C. K. Yuen, P. W. Lau, Y. L. To, K. C. Chow

Abstract:

Six-minute walk test (6MWT) is a sub-maximal exercise test to assess aerobic capacity and exercise tolerance of patients with chronic respiratory disease and heart failure. This has been proven to be a reliable and valid tool and commonly used in clinical situations. Traditional 6MWT is labour-intensive and time-consuming especially for patients who require assistance in ambulation and oxygen use. When performing the test with these patients, one staff will assist the patient in walking (with or without aids) while another staff will need to manually record patient’s oxygen saturation, heart rate and walking distance at every minute and/or carry oxygen cylinder at the same time. Physiotherapist will then have to document the test results in bed notes in details. With the use of electronic 6MWT (E-6MWT), patients wear a wireless oximeter that transfers data to a tablet PC via Bluetooth. Real-time recording of oxygen saturation, heart rate, and distance are displayed. No manual work on recording is needed. The tablet will generate a comprehensive report which can be directly attached to the patient’s bed notes for documentation. Data can also be saved for later patient follow up. This study was carried out in North District Hospital. Patients who followed commands and required 6MWT assessment were included. Patients were assigned to study or control groups. In the study group, patients adopted the E-6MWT while those in control group adopted the traditional 6MWT. Manpower and time consumed were recorded. Physiotherapists also completed a questionnaire about the use of E-6MWT. Total 12 subjects (Study=6; Control=6) were recruited during 11-12/2017. An average number of staff required and time consumed in traditional 6MWT were 1.67 and 949.33 seconds respectively; while in E-6MWT, the figures were 1.00 and 630.00 seconds respectively. Compared to traditional 6MWT, E-6MWT required 67.00% less manpower and 50.10% less in time spent. Physiotherapists (n=7) found E-6MWT is convenient to use (mean=5.14; satisfied to very satisfied), requires less manpower and time to complete the test (mean=4.71; rather satisfied to satisfied), has better data management (mean=5.86; satisfied to very satisfied) and is recommended to be used clinically (mean=5.29; satisfied to very satisfied). It is proven that E-6MWT requires less manpower input with higher efficiency and better data management. It is welcomed by the clinical frontline staff.

Keywords: electronic, physiotherapy, six-minute walk test, 6MWT

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7781 Smart Card Technology Adaption in a Hospital Setting

Authors: H. K. V. Narayan

Abstract:

This study was conducted at Tata Memorial Hospital (TMH), Mumbai, India. The study was to evaluate the impact of adapting Smart Card (SC) for clinical and business transactions in order to reduce Lead times and to enforce business rules of the hospital. The objective for implementing the Smart Card was to improve the patient perception of quality in terms of structures process and outcomes and also to improve the productivity of the Institution. The Smart Card was implemented in phases from 2011 and integrated with the Hospital Information System (HIS/EMR). The implementation was a learning curve for all the stake holders as software obviated the need to use hardcopies of transactions. The acceptability to the stake holders was challenge in change management. The study assessed the impact 3 years into the implementation and the observed trends have suggested that it has decreased the lead times for services and increased the no of transactions and thereby the productivity. Patients who used to complain of multiple queues and cumbersome transactions now compliment the administration for effective use of Information and Communication Technology.

Keywords: smart card, high availability of health care information, reduction in potential medical errors due to elimination of transcription errors, reduction in no of queues, increased transactions, augmentation of revenue

Procedia PDF Downloads 271
7780 Secured Embedding of Patient’s Confidential Data in Electrocardiogram Using Chaotic Maps

Authors: Butta Singh

Abstract:

This paper presents a chaotic map based approach for secured embedding of patient’s confidential data in electrocardiogram (ECG) signal. The chaotic map generates predefined locations through the use of selective control parameters. The sample value difference method effectually hides the confidential data in ECG sample pairs at these predefined locations. Evaluation of proposed method on all 48 records of MIT-BIH arrhythmia ECG database demonstrates that the embedding does not alter the diagnostic features of cover ECG. The secret data imperceptibility in stego-ECG is evident through various statistical and clinical performance measures. Statistical metrics comprise of Percentage Root Mean Square Difference (PRD) and Peak Signal to Noise Ratio (PSNR). Further, a comparative analysis between proposed method and existing approaches was also performed. The results clearly demonstrated the superiority of proposed method.

Keywords: chaotic maps, ECG steganography, data embedding, electrocardiogram

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7779 Effects of Using Clinical Guidelines for Feeding through a Gastrostomy Tube in Critically ill Surgical Patients Songkla Hospital Thailand

Authors: Siriporn Sikkaphun

Abstract:

Food is essential for living, and receiving correct, suitable, and adequate food is advantageous to the body, especially for patients because it can enable good recovery. Feeding through a gastrostomy tube is one useful way that is widely used because it is easy, convenient, and economical.To compare the effectiveness of using the clinical guidelines for feeding through a gastrostomy tube in critically ill surgical patients.This is a pre-post quasi-experimental study on 15 critically ill surgical or accident patients who needed intubation and the gastrostomy tube from August 2011 to November 2012. The data were collected using the guidelines, and an evaluation form for effectiveness of guidelines for feeding through a gastrostomy tube in critically ill surgical patients. After using the guidelines for feeding through a gastrostomy tube in critically ill surgical patients, it was found that The average number of days from the admission date to the day the patients received food through the G-tube significantly reduced at the level .05. The number of personnel who practiced nursing activities correctly and suitably for patients with complications during feeding significantly increased at the level .05.The number of patients receiving energy to the target level significantly increased at the level .05. The results of this study indicated that the use of the guidelines for feeding through a gastrostomy tube in critically ill surgical patients was feasible in practice, and the outcomes were beneficial to the patients.

Keywords: clinical guidelines, feeding, gastrostomy tube, critically ill, surgical patients

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7778 The Effectiveness of Laser In situ Keratomileusis for Correction Various Types of Refractive Anomalies

Authors: Yuliya Markava

Abstract:

The laser in situ keratomileusis (LASIK) is widely common surgical procedure, which has become an alternative for patients who are not satisfied with the performance of other correction methods. A high level of patient satisfaction functional outcomes after refractive surgery confirms the high reliability and safety of LASIK and provides a significant improvement in the quality of life and social adaptation. Purpose: To perform clinical analysis of the results of correction made to the excimer laser system SCHWIND AMARIS 500E in patients with different types of refractive anomalies. Materials and Methods: This was a retrospective analysis of 1581 operations (812 patients): 413 males (50.86%) and 399 females (49.14%) at the age from 18 to 47 years with different types of ametropia. All operations were performed on excimer laser SCHWIND AMARIS 500E in the LASIK procedure. Formation of the corneal flap was made by mechanical microkeratome SCHWIND. Results: Analyzing the structure of refractive anomalies: The largest number of interventions accounted for myopia: 1505 eyes (95.2%), of which about a low myopia: 706 eyes (44.7%), moderate myopia: 562 eyes (35.5 %), high myopia: eyes 217 (13.7%) and supermyopia: 20 eyes (1.3%). Hyperopia was 0.7% (11 eyes), mixed astigmatism: 4.1% (65 eyes). The efficiency was 80% (in patients with supermyopia) to 91.6% and 95.4% (in groups with myopia low and moderate, respectively). Uncorrected visual acuity average values before and after laser operation was in groups: a low myopia 0.18 (up 0.05 to 0.31) and 0.80 (up 0.60 to 1.0); moderate myopia 0.08 (up 0.03 to 0.13) and 0.87 ( up 0.74 to 1.0); high myopia 0.05 (up 0.02 to 0.08) and 0.83 (up 0.66 to 1.0); supermyopia 0.03 (up 0.02 to 0.04) and 0.59 ( up 0.34 to 0.84); hyperopia 0.27 (up 0.16 to 0.38) and 0.57 (up 0.27 to 0.87); mixed astigmatism of 0.35 (up 0.19 to 0.51) and 0.69 (up 0.44 to 0.94). In all cases, after LASIK indicators uncorrected visual acuity significantly increased. Reoperation was 4.43%. Significance: Clinical results of refractive surgery at the excimer laser system SCHWIND AMARIS 500E in different ametropia correction is characterized by high efficiency.

Keywords: effectiveness of laser correction, LASIK, refractive anomalies, surgical treatment

Procedia PDF Downloads 242
7777 Effective Use of X-Box Kinect in Rehabilitation Centers of Riyadh

Authors: Reem Alshiha, Tanzila Saba

Abstract:

Physical rehabilitation is the process of helping people to recover and be able to go back to their former activities that have been delayed due to external factors such as car accidents, old age and victims of strokes (chronic diseases and accidents, and those related to sport activities).The cost of hiring a personal nurse or driving the patient to and from the hospital could be costly and time-consuming. Also, there are other factors to take into account such as forgetfulness, boredom and lack of motivation. In order to solve this dilemma, some experts came up with rehabilitation software to be used with Microsoft Kinect to help the patients and their families for in-home rehabilitation. In home rehabilitation software is becoming more and more popular, since it is more convenient for all parties affiliated with the patient. In contrast to the other costly market-based systems that have no portability, Microsoft’s Kinect is a portable motion sensor that reads body movements and interprets it. New software development has made rehabilitation games available to be used at home for the convenience of the patient. The game will benefit its users (rehabilitation patients) in saving time and money. There are many software's that are used with the Kinect for rehabilitation, but the software that is chosen in this research is Kinectotherapy. Kinectotherapy software is used for rehabilitation patients in Riyadh clinics to test its acceptance by patients and their physicians. In this study, we used Kinect because it was affordable, portable and easy to access in contrast to expensive market-based motion sensors. This paper explores the importance of in-home rehabilitation by using Kinect with Kinectotherapy software. The software targets both upper and lower limbs, but in this research, the main focus is on upper-limb functionality. However, the in-home rehabilitation is applicable to be used by all patients with motor disability, since the patient must have some self-reliance. The targeted subjects are patients with minor motor impairment that are somewhat independent in their mobility. The presented work is the first to consider the implementation of in-home rehabilitation with real-time feedback to the patient and physician. This research proposes the implementation of in-home rehabilitation in Riyadh, Saudi Arabia. The findings show that most of the patients are interested and motivated in using the in-home rehabilitation system in the future. The main value of the software application is due to these factors: improve patient engagement through stimulating rehabilitation, be a low cost rehabilitation tool and reduce the need for expensive one-to-one clinical contact. Rehabilitation is a crucial treatment that can improve the quality of life and confidence of the patient as well as their self-esteem.

Keywords: x-box, rehabilitation, physical therapy, rehabilitation software, kinect

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7776 Clinical Pharmacology Throughout the World: A View from Global Health

Authors: Ragy Raafat Gaber Attaalla

Abstract:

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

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

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7775 Best Practices to Enhance Patient Security and Confidentiality When Using E-Health in South Africa

Authors: Lethola Tshikose, Munyaradzi Katurura

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Information and Communication Technology (ICT) plays a critical role in improving daily healthcare processes. The South African healthcare organizations have adopted Information Systems to integrate their patient records. This has made it much easier for healthcare organizations because patient information can now be accessible at any time. The primary purpose of this research study was to investigate the best practices that can be applied to enhance patient security and confidentiality when using e-health systems in South Africa. Security and confidentiality are critical in healthcare organizations as they ensure safety in EHRs. The research study used an inductive research approach that included a thorough literature review; therefore, no data was collected. The research paper’s scope included patient data and possible security threats associated with healthcare systems. According to the study, South African healthcare organizations discovered various patient data security and confidentiality issues. The study also revealed that when it comes to handling patient data, health professionals sometimes make mistakes. Some may not be computer literate, which posed issues and caused data to be tempered with. The research paper recommends that healthcare organizations ensure that security measures are adequately supported and promoted by their IT department. This will ensure that adequate resources are distributed to keep patient data secure and confidential. Healthcare organizations must correctly use standards set up by IT specialists to solve patient data security and confidentiality issues. Healthcare organizations must make sure that their organizational structures are adaptable to improve security and confidentiality.

Keywords: E-health, EHR, security, confidentiality, healthcare

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7774 The Twain Shall Meet: First Year Writing Skills in Senior Year Project Design

Authors: Sana Sayed

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The words objectives, outcomes, and assessment are commonplace in academia. Educators, especially those who use their emotional intelligence as a useful teaching tool, strive to find creative and innovative ways to connect to their students while meeting the objectives, outcomes, and assessment measures for their respective courses. However, what happens to these outcomes once the objectives have been met, students have completed a specific course, and generic letter grades have been generated? How can their knowledge and acquired skills be assessed over the course of semesters, throughout their years of study, and until their final year right before they graduate? Considering the courses students complete for different departments in various disciplines, how can these outcomes be measured, or at least maintained, across the curriculum? This research-driven paper uses the key course outcomes of first year, required writing courses and traces them in two senior level, required civil engineering design courses at the American University of Sharjah, which is located in the United Arab Emirates. The purpose of this research is two-fold: (1) to assess specific learning outcomes using a case study that focuses on courses from two different disciplines during two very distinctive years of study, and (2) to demonstrate how learning across the curriculum fosters life-long proficiencies among graduating students that are aligned with a university’s mission statement.

Keywords: assessment, learning across the curriculum, objectives, outcomes

Procedia PDF Downloads 291
7773 The Functional Rehabilitation of Peri-Implant Tissue Defects: A Case Report

Authors: Özgür Öztürk, Cumhur Sipahi, Hande Yeşil

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Implant retained restorations commonly consist of a metal-framework veneered with ceramic or composite facings. The increasing and expanding use of indirect resin composites in dentistry is a result of innovations in materials and processing techniques. Of special interest to the implant restorative field is the possibility that composites present significantly lower peak vertical and transverse forces transmitted at the peri-implant level compared to metal-ceramic supra structures in implant-supported restorations. A 43-year-old male patient referred to the department of prosthodontics for an implant retained fixed prosthesis. The clinical and radiographic examination of the patient demonstrated the presence of an implant in the right mandibular first molar tooth region. A considerable amount of marginal bone loss around the implant was detected in radiographic examinations combined with a remarkable peri-implant soft tissue deficiency. To minimize the chewing loads transmitted to the implant-bone interface it was decided to fabricate an indirect composite resin veneered single metal crown over a screw-retained abutment. At the end of the treatment, the functional and aesthetic deficiencies were fully compensated. After a 6 months clinical and radiographic follow-up period the not any additional pathologic invasion was detected in the implant-bone interface and implant retained restoration did not reveal any vehement complication.

Keywords: dental implant, fixed partial dentures, indirect composite resin, peri-implant defects

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7772 Multicenter Evaluation of the ACCESS Anti-HCV Assay on the DxI 9000 ACCESS Immunoassay Analyzer, for the Detection of Hepatitis C Virus Antibody

Authors: Dan W. Rhodes, Juliane Hey, Magali Karagueuzian, Florianne Martinez, Yael Sandowski, Vanessa Roulet, Mahmoud Badawi, Mohammed-Amine Chakir, Valérie Simon, Jérémie Gautier, Françoise Le Boulaire, Catherine Coignard, Claire Vincent, Sandrine Greaume, Isabelle Voisin

Abstract:

Background: Beckman Coulter, Inc. (BEC) has recently developed a fully automated second-generation anti-HCV test on a new immunoassay platform. The objective of this multicenter study conducted in Europe was to evaluate the performance of the ACCESS anti-HCV assay on the recently CE-marked DxI 9000 ACCESS Immunoassay Analyzer as an aid in the diagnosis of HCV (Hepatitis C Virus) infection and as a screening test for blood and plasma donors. Methods: The clinical specificity of the ACCESS anti-HCV assay was determined using HCV antibody-negative samples from blood donors and hospitalized patients. Sample antibody status was determined by a CE-marked anti-HCV assay (Abbott ARCHITECTTM anti-HCV assay or Abbott PRISM HCV assay) with an additional confirmation method (Immunoblot testing with INNO-LIATM HCV Score - Fujirebio), if necessary, according to pre-determined testing algorithms. The clinical sensitivity was determined using known HCV antibody-positive samples, identified positive by Immunoblot testing with INNO-LIATM HCV Score - Fujirebio. HCV RNA PCR or genotyping was available on all Immunoblot positive samples for further characterization. The false initial reactive rate was determined on fresh samples from blood donors and hospitalized patients. Thirty (30) commercially available seroconversion panels were tested to assess the sensitivity for early detection of HCV infection. The study was conducted from November 2019 to March 2022. Three (3) external sites and one (1) internal site participated. Results: Clinical specificity (95% CI) was 99.7% (99.6 – 99.8%) on 5852 blood donors and 99.0% (98.4 – 99.4%) on 1527 hospitalized patient samples. There were 15 discrepant samples (positive on ACCESS anti-HCV assay and negative on both ARCHITECT and Immunoblot) observed with hospitalized patient samples, and of note, additional HCV RNA PCR results showed five (5) samples had positive HCV RNA PCR results despite the absence of HCV antibody detection by ARCHITECT and Immunoblot, suggesting a better sensitivity of the ACCESS anti-HCV assay with these five samples compared to the ARCHITECT and Immunoblot anti-HCV assays. Clinical sensitivity (95% CI) on 510 well-characterized, known HCV antibody-positive samples was 100.0% (99.3 – 100.0%), including 353 samples with known HCV genotypes (1 to 6). The overall false initial reactive rate (95% CI) on 6630 patient samples was 0.02% (0.00 – 0.09%). Results obtained on 30 seroconversion panels demonstrated that the ACCESS anti-HCV assay had equivalent sensitivity performances, with an average bleed difference since the first reactive bleed below one (1), compared to the ARCHITECTTM anti-HCV assay. Conclusion: The newly developed ACCESS anti-HCV assay from BEC for use on the DxI 9000 ACCESS Immunoassay Analyzer demonstrated high clinical sensitivity and specificity, equivalent to currently marketed anti-HCV assays, as well as a low false initial reactive rate.

Keywords: DxI 9000 ACCESS Immunoassay Analyzer, HCV, HCV antibody, Hepatitis C virus, immunoassay

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7771 Harnessing Clinical Trial Capacity to Mitigate Zoonotic Diseases: The Role of Expert Scientists in Ethiopia

Authors: Senait Belay Adugna, Mirutse Giday, Tsegahun Manyazewal

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

Keywords: Ethiopia, clinical triak, zoonoses, disease

Procedia PDF Downloads 78