Search results for: observational patient registry
Commenced in January 2007
Frequency: Monthly
Edition: International
Paper Count: 3525

Search results for: observational patient registry

2055 Artificial Intelligence and Liability within Healthcare: A South African Analysis

Authors: M. Naidoo

Abstract:

AI in healthcare can have a massive positive effect in low-resource states like South Africa, where patients outnumber personnel greatly. However, the complexity and ‘black box’ aspects of these technologies pose challenges for the liability regimes of states. This is currently being discussed at the international level. This research finds that within the South African medical negligence context, the current common law fault-based inquiry proves to be wholly inadequate for patient redress. As a solution to this, this research paper culminates in legal reform recommendations designed to solve these issues.

Keywords: artificial intelligence, law, liability, policy

Procedia PDF Downloads 115
2054 Telemedicine for Telerehabilitation in Areas Affected by Social Conflicts in Colombia

Authors: Lilia Edit Aparicio Pico, Paulo Cesar Coronado Sánchez, Roberto Ferro Escobar

Abstract:

This paper presents the implementation of telemedicine services for physiotherapy, occupational therapy, and speech therapy rehabilitation, utilizing telebroadcasting of audiovisual content to enhance comprehensive patient recovery in rural areas of San Vicente del Caguán municipality, characterized by high levels of social conflict in Colombia. The region faces challenges such as dysfunctional problems, physical rehabilitation needs, and a high prevalence of hearing diseases, leading to neglect and substandard health services. Limited access to healthcare due to communication barriers and transportation difficulties exacerbates these issues. To address these challenges, a research initiative was undertaken to leverage information and communication technologies (ICTs) to improve healthcare quality and accessibility for this vulnerable population. The primary objective was to develop a tele-rehabilitation system to provide asynchronous online therapies and teleconsultation services for patient follow-up during the recovery process. The project comprises two components: Communication systems and human development. A technological component involving the establishment of a wireless network connecting rural centers and the development of a mobile application for video-based therapy delivery. Communications systems will be provided by a radio link that utilizes internet provided by the Colombian government, located in the municipality of San Vicente del Caguán to connect two rural centers (Pozos and Tres Esquinas) and a mobile application for managing videos for asynchronous broadcasting in sidewalks and patients' homes. This component constitutes an operational model integrating information and telecommunications technologies. The second component involves pedagogical and human development. The primary focus is on the patient, where performance indicators and the efficiency of therapy support were evaluated for the assessment and monitoring of telerehabilitation results in physical, occupational, and speech therapy. They wanted to implement a wireless network to ensure audiovisual content transmission for tele-rehabilitation, design audiovisual content for tele-rehabilitation based on services provided by the ESE Hospital San Rafael in physiotherapy, occupational therapy, and speech therapy, develop a software application for fixed and mobile devices enabling access to tele-rehabilitation audiovisual content for healthcare personnel and patients and finally to evaluate the technological solution's contribution to the ESE Hospital San Rafael community. The research comprised four phases: wireless network implementation, audiovisual content design, software application development, and evaluation of the technological solution's impact. Key findings include the successful implementation of virtual teletherapy, both synchronously and asynchronously, and the assessment of technological performance indicators, patient evolution, timeliness, acceptance, and service quality of tele-rehabilitation therapies. The study demonstrated improved service coverage, increased care supply, enhanced access to timely therapies for patients, and positive acceptance of teletherapy modalities. Additionally, the project generated new knowledge for potential replication in other regions and proposed strategies for short- and medium-term improvement of service quality and care indicators

Keywords: e-health, medical informatics, telemedicine, telerehabilitation, virtual therapy

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2053 Targeting Glucocorticoid Receptor Eliminate Dormant Chemoresistant Cancer Stem Cells in Glioblastoma

Authors: Aoxue Yang, Weili Tian, Yonghe Wu, Haikun Liu

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Brain tumor stem cells (BTSCs) are resistant to therapy and give rise to recurrent tumors. These rare and elusive cells are likely to disseminate during cancer progression, and some may enter dormancy, remaining viable but not increasing. The identification of dormant BTSCs is thus necessary to design effective therapies for glioblastoma (GBM) patients. Little progress has been made in therapeutic treatment of glioblastoma in the last decade despite rapid progress in molecular understanding of brain tumors1. Here we show that the stress hormone glucocorticoid is essential for the maintenance of brain tumor stem cells (BTSCs), which are resistant to conventional therapy. The glucocorticoid receptor (GR) regulates metabolic plasticity and chemoresistance of the dormant BTSC via controlling expression of GPD1 (glycerol-3-phosphate dehydrogenase 1), which is an essential regulator of lipid metabolism in BTSCs. Genomic, lipidomic and cellular analysis confirm that GR/GPD1 regulation is essential for BTSCs metabolic plasticity and survival. We further demonstrate that the GR agonist dexamethasone (DEXA), which is commonly used to control edema in glioblastoma, abolishes the effect of chemotherapy drug temozolomide (TMZ) by upregulating GPD1 and thus promoting tumor cell dormancy in vivo, this provides a mechanistic explanation and thus settle the long-standing debate of usage of steroid in brain tumor patient edema control. Pharmacological inhibition of GR/GPD1 pathway disrupts metabolic plasticity of BTSCs and prolong animal survival, which is superior to standard chemotherapy. Patient case study shows that GR antagonist mifepristone blocks tumor progression and leads to symptomatic improvement. This study identifies an important mechanism regulating cancer stem cell dormancy and provides a new opportunity for glioblastoma treatment.

Keywords: cancer stem cell, dormancy, glioblastoma, glycerol-3-phosphate dehydrogenase 1, glucocorticoid receptor, dexamethasone, RNA-sequencing, phosphoglycerides.

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2052 The Dual Catastrophe of Behçet’s Disease Visual Loss Followed by Acute Spinal Shock After Lumbar Drain Removal

Authors: Naim Izet Kajtazi

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Context: Increased intracranial pressure and associated symptoms such as headache, papilledema, motor or sensory deficits, seizures, and conscious disturbance are well-known in acute CVT. However, visual loss is not commonly associated with this disease, except in the case of secondary IIH associated with it. Process: We report a case of a 40-year-old male with Behçet’s disease and cerebral venous thrombosis, and other multiple comorbidities admitted with a four-day history of increasing headache and rapidly progressive visual loss bilaterally. The neurological examination was positive for bilateral papilledema of grade 3 with light perception on the left eye and counting fingers on the right eye. Brain imaging showed old findings of cerebral venous thrombosis without any intraparenchymal lesions to suggest a flare-up of Behçet’s disease. The lumbar puncture, followed by the lumbar drain insertion, gave no benefit in headache or vision. However, he completely lost sight. The right optic nerve sheath fenestration did not result in vision improvement. The acute spinal shock complicated the lumbar drain removal due to epidural hematoma. An urgent lumbar laminectomy with hematoma evacuation undertook. Intra-operatively, the neurosurgeon noted suspicious abnormal vessels at conus medullaris with the possibility of an arteriovenous malformation. Outcome: In a few days following the spinal surgery, the patient vision started to improve. Further improvement was achieved after plasma exchange sessions followed by cyclophosphamide. In the recent follow-up in the clinic, he reported better vision, drove, and completed his Ph.D. studies. Relevance: Visual loss in patients with Behçet’s disease should always be anticipated and taken reasonable care of, ensuring that they receive well-combined immunosuppression with anticoagulation and agents to reduce intracranial pressure. This patient’s story is significant for a high disease burden and complicated hospital course by acute spinal shock due to spinal lumbar drain removal with a possible underlying spinal arteriovenous malformation.

Keywords: Behcet disease, optic neuritis, IIH, CVT

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2051 Endometriosis-Associated Ovarian Cancer: Clinical and Pathological Pattern

Authors: I. Ramalho, S. Campos, M. Dias

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Introduction: Endometriosis may play a role in the pathogenesis of ovarian cancer (OC), however, the risk and prognosis have not been well established. The association between these two pathologies could have an important impact on prevention and early diagnosis of OC. Objective: To analyze the prevalence of endometriosis associated ovarian cancer and related clinical, epidemiological and histopathological issues. Design: We conducted a retrospective case series analysis of patients diagnosed with endometriosis and ovarian cancer in the Gynecology Department of Coimbra University Hospital Center since 2006 to 2015. Methods: We collected data from women diagnosed with ovarian cancer, with anatomopathology records reporting findings of endometriosis in ovarian cancer patients. Patients were retrieved from the pathological records and appropriate medical records were retrospectively reviewed. Statistical analysis was performed using SPSS 22.0. Results: Histological evidence of endometriosis was found in 17 out of 261 patients diagnosed with ovarian cancer (OC) (6.51%). The most usual symptoms were pelvic pain, abdominal distension, asthenia, ascites, weight loss and nausea. Mean age at diagnosis was 61.2 ± 15.1, 41-86 years old, 33.3% were pre-menopausal patients and cancer stage distribution was predominantly stage I (31.3%) and stage III (56.3%). OC occurred unilaterally in 14 patients and 2 patients were diagnosed with a synchronous ovarian and endometrial cancer. Regarding histological type, 10 OC were classified as clear cell carcinoma (CCC), 4 endometrioid carcinomas (EC) and 3 mixed type (clear cell and endometrioid). Four ovarian carcinomas presumably arose from endometriomas: 3 CCC and 1 EC. Conclusions: In accordance with previous studies, clear cell was the most common pathological type in endometriotic patients, followed by endometrioid carcinomas, and two rare synchronous ovarian and endometrial carcinomas were registered. Although endometriosis association to OC is uncommon, endometriosis should be managed with special care in order to early diagnosis.

Keywords: endometriosis, histology, observational study, ovarian cancer

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2050 The Improvement in Clinical Outcomes with the Histological Presence of Nidus Following Radiofrequency Ablation (RFA) for Osteoid Osteoma (OO)

Authors: Amirul Adlan, Motaz AlAqeel, Scott Evans, Vaiyapuri sumathi, Mark Davies, Rajesh Botchu

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Background & Objectives: Osteoid osteoma (OO) is a benign tumor of the bone commonly found in childhood and adolescence, causing bone pain, especially during the night. CT-guided radiofrequency ablation (RFA) is currently the mainstay treatment for OO. There is currently no literature reporting the outcomes of OO following RFA based on the histological presence of a nidus seen on a biopsy taken at the time of RFA. The primary aim of this study was to compare the clinical outcomes of OO between the group of patients with the presence of nidus on biopsy samples from RFA with those without nidus. Secondly, we aimed to examine other factors that may affect the outcomes of OO, reflecting our experience as a tertiary orthopedic oncology center. Methods: We retrospectively reviewed 88 consecutive patients diagnosed with osteoid osteoma treated with RFA between November 2005 and March 2015, consisting of 63 males (72%) and 25 females (28%). Sixty-six patients (75%) had nidus present in their biopsy samples. Patients’ mean age was 17.6 years (4-53). The median duration of follow-up was 12.5 months (6-20.8). Lesions were located in the appendicular skeleton in seventy-nine patients (90%), while nine patients (10%) had an OO in the axial skeleton. Outcomes assessed were based on patients’ pain alleviation (partial, complete, or no pain improvement) and the need for further interventions. Results: Pain improvement in the patient group with nidus in the histology sample was significantly better than in the group without nidus (OR 7.4, CI 1.35-41.4, p=0.021). The patient group with nidus on biopsy demonstrated less likelihood of having a repeat procedure compared to the group without nidus(OR 0.092, CI 0.016-0.542, p=0.008). Our study showed significantly better outcomes in pain improvement in appendicular lesions compared to the axially located lesions (p = 0.005). Patients with spinal lesions tend to have relatively poor pain relief than those with appendicular or pelvic lesions (p=0.007). Conclusions: Patients with nidus on histology had better pain alleviation compared to patients without nidus. The histological presence of nidus significantly reduces the chance of repeat interventions. The pain alleviation of osteoid osteoma following RFA is better in patients with appendicular lesions than spinal or axially located lesions.

Keywords: osteoid osteoma, benign tumour, radiofrequency ablation, oncology

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2049 Development of PVA/polypyrrole Scaffolds by Supercritical CO₂ for Its Application in Biomedicine

Authors: Antonio Montes, Antonio Cozar, Clara Pereyra, Diego Valor, Enrique Martinez de la Ossa

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Tissues and organs can be damaged because of traumatism, congenital illnesses, or cancer and the traditional therapeutic alternatives, such as surgery, cannot usually completely repair the damaged tissues. Tissue engineering allows regeneration of the patient's tissues, reducing the problems caused by the traditional methods. Scaffolds, polymeric structures with interconnected porosity, can be promoted the proliferation and adhesion of the patient’s cells in the damaged area. Furthermore, by means of impregnation of the scaffold with beneficial active substances, tissue regeneration can be induced through a drug delivery process. The objective of the work is the fabrication of a PVA scaffold coated with Gallic Acid and polypyrrole through a one-step foaming and impregnation process using the SSI technique (Supercritical Solvent Impregnation). In this technique, supercritical CO₂ penetrates into the polymer chains producing the plasticization of the polymer. In the depressurization step a CO₂ cellular nucleation and growing to take place to an interconnected porous structure of the polymer. The foaming process using supercritical CO₂ as solvent and expansion agent presents advantages compared to the traditional scaffolds’ fabrication methods, such as the polymer’s high solubility in the solvent or the possibility of carrying out the process at a low temperature, avoiding the inactivation of the active substance. In this sense, the supercritical CO₂ avoids the use of organic solvents and reduces the solvent residues in the final product. Moreover, this process does not require long processing time that could cause the stratification of substance inside the scaffold reducing the therapeutic efficiency of the formulation. An experimental design has been carried out to optimize the SSI technique operating conditions, as well as a study of the morphological characteristics of the scaffold for its use in tissue engineerings, such as porosity, conductivity or the release profiles of the active substance. It has been proved that the obtained scaffolds are partially porous, conductors of electricity and are able to release Gallic Acid in the long term.

Keywords: scaffold, foaming, supercritical, PVA, polypyrrole, gallic acid

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2048 Management of Femoral Neck Stress Fractures at a Specialist Centre and Predictive Factors to Return to Activity Time: An Audit

Authors: Charlotte K. Lee, Henrique R. N. Aguiar, Ralph Smith, James Baldock, Sam Botchey

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Background: Femoral neck stress fractures (FNSF) are uncommon, making up 1 to 7.2% of stress fractures in healthy subjects. FNSFs are prevalent in young women, military recruits, endurance athletes, and individuals with energy deficiency syndrome or female athlete triad. Presentation is often non-specific and is often misdiagnosed following the initial examination. There is limited research addressing the return–to–activity time after FNSF. Previous studies have demonstrated prognostic time predictions based on various imaging techniques. Here, (1) OxSport clinic FNSF practice standards are retrospectively reviewed, (2) FNSF cohort demographics are examined, (3) Regression models were used to predict return–to–activity prognosis and consequently determine bone stress risk factors. Methods: Patients with a diagnosis of FNSF attending Oxsport clinic between 01/06/2020 and 01/01/2020 were selected from the Rheumatology Assessment Database Innovation in Oxford (RhADiOn) and OxSport Stress Fracture Database (n = 14). (1) Clinical practice was audited against five criteria based on local and National Institute for Health Care Excellence guidance, with a 100% standard. (2) Demographics of the FNSF cohort were examined with Student’s T-Test. (3) Lastly, linear regression and Random Forest regression models were used on this patient cohort to predict return–to–activity time. Consequently, an analysis of feature importance was conducted after fitting each model. Results: OxSport clinical practice met standard (100%) in 3/5 criteria. The criteria not met were patient waiting times and documentation of all bone stress risk factors. Importantly, analysis of patient demographics showed that of the population with complete bone stress risk factor assessments, 53% were positive for modifiable bone stress risk factors. Lastly, linear regression analysis was utilized to identify demographic factors that predicted return–to–activity time [R2 = 79.172%; average error 0.226]. This analysis identified four key variables that predicted return-to-activity time: vitamin D level, total hip DEXA T value, femoral neck DEXA T value, and history of an eating disorder/disordered eating. Furthermore, random forest regression models were employed for this task [R2 = 97.805%; average error 0.024]. Analysis of the importance of each feature again identified a set of 4 variables, 3 of which matched with the linear regression analysis (vitamin D level, total hip DEXA T value, and femoral neck DEXA T value) and the fourth: age. Conclusion: OxSport clinical practice could be improved by more comprehensively evaluating bone stress risk factors. The importance of this evaluation is demonstrated by the population found positive for these risk factors. Using this cohort, potential bone stress risk factors that significantly impacted return-to-activity prognosis were predicted using regression models.

Keywords: eating disorder, bone stress risk factor, femoral neck stress fracture, vitamin D

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2047 Factors Affecting the Fear of Insulin Injection and Finger Punching in Individuals Diagnosed with Diabetes

Authors: Gaye Demi̇rtaş Adli

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Research: It was conducted to determine the factors affecting the fear of self-injection and self-pricking of fingers of diabetic individuals.The study was conducted as a cross-sectional, relation-seeking, and descriptive study. The study was conducted on 122 patients who had just started insulin therapy. Data were obtained through The Descriptive Patient Form, The Diabetic Self-Injection, and the Fear of Testing Questionnaire Form (D-FISQ). Descriptive statistical methods used in the evaluation of data are the Mann-Whitney U test, Kruskal-Wallis H test, and the Spearman correlation. The factors affecting the scale scores were evaluated with multiple linear regression analysis. The value of P<0.05 was considered statistically significant. Study group: 56.6% of the patients are male patients. Fear of self-injection (injection), fear of self-testing (test), and total fear (total) scores of women were found to be statistically higher than men (p<0.001). Age, gender, and pain experience were important variables that affected patients' fear of injections. With a one-unit increase in age, the injection fear score decreased by 0.13 points, and the mean injection fear score of women was 2.11 points higher than that of men. It was determined that the patient's age, gender, living with whom, and blood donation history were important variables affecting the fear of self-testing. It is seen that the fear test score decreases by 0.18 points with an increase in age by one unit, and the fear test scores of women compared to men are on average 3,358 points, the fear test scores of those living alone are 4,711 points compared to those living with family members, and the fear test scores of those who do not donate blood are 2,572 compared to those who donate blood score, it was determined that those with more pain experience were 3,156 points higher on average than those with less fear of injection. As a result, it was seen that the most important factors affecting the fear of insulin injection and finger punching in individuals with diabetes were age, gender, pain experience, living with whom, and blood donation history.

Keywords: diabetes, needle phobia, fear of injection, insulin injection

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2046 Neuroanatomical Specificity in Reporting & Diagnosing Neurolinguistic Disorders: A Functional & Ethical Primer

Authors: Ruairi J. McMillan

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Introduction: This critical analysis aims to ascertain how well neuroanatomical aetiologies are communicated within 20 case reports of aphasia. Neuroanatomical visualisations based on dissected brain specimens were produced and combined with white matter tract and vascular taxonomies of function in order to address the most consistently underreported features found within the aphasic case study reports. Together, these approaches are intended to integrate aphasiological knowledge from the past 20 years with aphasiological diagnostics, and to act as prototypal resources for both researchers and clinical professionals. The medico-legal precedent for aphasia diagnostics under Canadian, US and UK case law and the neuroimaging/neurological diagnostics relative to the functional capacity of aphasic patients are discussed in relation to the major findings of the literary analysis, neuroimaging protocols in clinical use today, and the neuroanatomical aetiologies of different aphasias. Basic Methodology: Literature searches of relevant scientific databases (e.g, OVID medline) were carried out using search terms such as aphasia case study (year) & stroke induced aphasia case study. A series of 7 diagnostic reporting criteria were formulated, and the resulting case studies were scored / 7 alongside clinical stroke criteria. In order to focus on the diagnostic assessment of the patient’s condition, only the case report proper (not the discussion) was used to quantify results. Statistical testing established if specific reporting criteria were associated with higher overall scores and potentially inferable increases in quality of reporting. Statistical testing of whether criteria scores were associated with an unclear/adjusted diagnosis were also tested, as well as the probability of a given criterion deviating from an expected estimate. Major Findings: The quantitative analysis of neuroanatomically driven diagnostics in case studies of aphasia revealed particularly low scores in the connection of neuroanatomical functions to aphasiological assessment (10%), and in the inclusion of white matter tracts within neuroimaging or assessment diagnostics (30%). Case studies which included clinical mention of white matter tracts within the report itself were distributed among higher scoring cases, as were case studies which (as clinically indicated) related the affected vascular region to the brain parenchyma of the language network. Concluding Statement: These findings indicate that certain neuroanatomical functions are integrated less often within the patient report than others, despite a precedent for well-integrated neuroanatomical aphasiology also being found among the case studies sampled, and despite these functions being clinically essential in diagnostic neuroimaging and aphasiological assessment. Therefore, ultimately the integration and specificity of aetiological neuroanatomy may contribute positively to the capacity and autonomy of aphasic patients as well as their clinicians. The integration of a full aetiological neuroanatomy within the reporting of aphasias may improve patient outcomes and sustain autonomy in the event of medico-ethical investigation.

Keywords: aphasia, language network, functional neuroanatomy, aphasiological diagnostics, medico-legal ethics

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2045 Assessment, Diagnosis and Treatment, Simulation for the Nurse Practitioner Student

Authors: Helen Coronel, Will Brewer, Peggy Bergeron, Clarissa Hall, Victoria Casson

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Simulation-based training provides the nurse practitioner (NP) student with a safe and controlled environment in which they can practice a real-life scenario. This type of learning fosters critical thinking skills essential to practice. The expectation of this study was that students would have an increase in their competency and confidence after performing the simulation. Approximately 8.4% of Americans suffer from depression. The state of Alabama is ranked 47th out of 50 for access to mental health care. As a result of this significant shortage of mental health providers, primary care providers are frequently put in the position of screening for and treating mental health conditions, such as depression. Family nurse practitioners are often utilized as primary care providers, making their ability to assess, diagnose and treat these disorders a necessary skill. The expected outcome of this simulation is an increase in confidence, competency and the empowerment of the nurse practitioner student’s ability to assess, diagnose and treat a common mood disorder they may encounter in practice. The Kirkpatrick Module was applied for this study. A non-experimental design using descriptive statistical analysis was utilized. The simulation was based on a common psychiatric mood disorder frequently observed in primary care and mental health clinics. Students were asked to watch a voiceover power point presentation prior to their on-campus simulation. The presentation included training on the assessment, diagnosis, and treatment of a patient with depression. Prior to the simulation, the students completed a pre-test, then participated in the simulation, and completed a post-test when done. Apple iPads were utilized to access a simulated health record. Major findings of the study support an increase in students’ competency and confidence when assessing, diagnosing, and treating an adult patient with depression.

Keywords: advanced practice, nurse practitioner, simulation, primary care, depression

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2044 Physics Informed Deep Residual Networks Based Type-A Aortic Dissection Prediction

Authors: Joy Cao, Min Zhou

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Purpose: Acute Type A aortic dissection is a well-known cause of extremely high mortality rate. A highly accurate and cost-effective non-invasive predictor is critically needed so that the patient can be treated at earlier stage. Although various CFD approaches have been tried to establish some prediction frameworks, they are sensitive to uncertainty in both image segmentation and boundary conditions. Tedious pre-processing and demanding calibration procedures requirement further compound the issue, thus hampering their clinical applicability. Using the latest physics informed deep learning methods to establish an accurate and cost-effective predictor framework are amongst the main goals for a better Type A aortic dissection treatment. Methods: Via training a novel physics-informed deep residual network, with non-invasive 4D MRI displacement vectors as inputs, the trained model can cost-effectively calculate all these biomarkers: aortic blood pressure, WSS, and OSI, which are used to predict potential type A aortic dissection to avoid the high mortality events down the road. Results: The proposed deep learning method has been successfully trained and tested with both synthetic 3D aneurysm dataset and a clinical dataset in the aortic dissection context using Google colab environment. In both cases, the model has generated aortic blood pressure, WSS, and OSI results matching the expected patient’s health status. Conclusion: The proposed novel physics-informed deep residual network shows great potential to create a cost-effective, non-invasive predictor framework. Additional physics-based de-noising algorithm will be added to make the model more robust to clinical data noises. Further studies will be conducted in collaboration with big institutions such as Cleveland Clinic with more clinical samples to further improve the model’s clinical applicability.

Keywords: type-a aortic dissection, deep residual networks, blood flow modeling, data-driven modeling, non-invasive diagnostics, deep learning, artificial intelligence.

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2043 Length of Pregnancy and Dental Caries Observation in Relation to BMI

Authors: Edit Xhajanka, Gresa Baboci, Irene Malagnino, Mimoza Canga, Vito Antonio Malagnino

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Purpose: This study aimed at identifying dental caries increment or reduction, based on factors such as smoking, the scaling of teeth, BMI before and during pregnancy, carbohydrates consumption in relation to childbirth. Material and method: In this observational study, the sample included a total of 98 pregnant women and their age class was 18-45 years old, with a median age of 31.5 years. The setting of the participants resides in Vlora –Albania. Moreover, 64.4% were from the city and 35.6% were from the nearby villages. The study was conducted in the time period January 2018 –June 2021. Body mass index (BMI) was calculated using the standard formula (kg/m²). Maternal pre, during and post-pregnancy BMI was collected by using a validated questionnaire. Statistical analysis was performed using IBM SPSS Statistics 23.0. The significance level (α) was set at 0.05, whereas P-value and analysis of variance (ANOVA) were used to analyze the data. Results: Based on the data analysis, 44.4% of the sample declared that they did smoke before pregnancy and 55.6% not smoked during their pregnancy. As a result, no association was found between smoking and length of pregnancy P=0.95. There is also a strong relation (P=0.000) between the number of teeth with caries before pregnancy and the number of teeth with caries during pregnancy. There is a significant relationship between the scaling of teeth and childbirth, P=0.05. BMI before and during pregnancy in relation to carbohydrates consumption have a significant correlation P=0.004 and P=0.002. The values of BMI before and during pregnancy in relation to childbirth have a strong correlation: P=0.043 and P=0.040, respectively. As a result, obesity was associated with preterm birth. The percentage of children born during 34-36 weeks of pregnancy was 69%, and children born during 32-34 weeks of pregnancy were 31%. CONCLUSION: There was a positive association between dental caries experience, BMI and carbohydrates consumption. Obesity in pregnancy is increasing worldwide; that is why this study suggests the importance of an appropriate weight before and during pregnancy.

Keywords: BMI, dental caries, pregnancy, scaling, smoking

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2042 Pattern of ICU Admission due to Drug Problems

Authors: Kamel Abd Elaziz Mohamed

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Introduction: Drug related problems (DRPs) are of major concern, affecting patients of both sex. They impose considerable economic burden on the society and the health-care systems. Aim of the work: The aim of this work was to identify and categorize drug-related problems in adult intensive care unit. Patients and methods: The study was a prospective, observational study as eighty six patients were included. They were consecutively admitted to ICU through the emergency room or transferred from the general ward due to DRPs. Parameters included in the study as length of stay in ICU, need for cardiovascular support or mechanical ventilation, dialysis, as well as APACHE II score were recorded. Results: Drug related problems represent 3.6% of the total ICU admission. The median (range) of APACHE II score for 86 patients included in the study was 17 (10-23), and length of ICU stay was 2.4 (1.5-4.2) days. In 45 patients (52%), DRP was drug over dose (group 1), while other DRP was present in the other 41 patients (48%, group 11). Patients in group 1 were older (39 years versus 32 years in group 11), with significant impaired renal function. The need of inotropic drugs and mechanical ventilation as well as the length of stay (LOS) in ICU was significantly higher in group 1. There were no significant difference in GCS between both groups, however APACHE II score was significantly higher in group 1. Only four patients (4.6%) were admitted by suicidal attempt as well as three patients (3.4%) due to trauma drug-related admissions, all were in (group 1). Nineteen percent of the patients had drug related problem due to hypoglycaemic medication followed by tranquilizer (15%). Adverse drug effect followed by failure to receive medication were the most causes of drug problem in (group11).The total mortality rate was 4.6%, all of them were eventually non preventable. Conclusion: The critically ill patients admitted due to drug related problems represented a small proportion (3.6%) of admissions to the ICU. Hypoglycaemic medication was one of the most common causes of admission by drug related problems.

Keywords: drug related problems, ICU, cost, safety

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2041 Reducing Diagnostic Error in Australian Emergency Departments Using a Behavioural Approach

Authors: Breanna Wright, Peter Bragge

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Diagnostic error rates in healthcare are approximately 10% of cases. Diagnostic errors can cause patient harm due to inappropriate, inadequate or delayed treatment, and such errors contribute heavily to medical liability claims globally. Therefore, addressing diagnostic error is a high priority. In most cases, diagnostic errors are the result of faulty information synthesis rather than lack of knowledge. Specifically, the majority of diagnostic errors involve cognitive factors, and in particular, cognitive biases. Emergency Departments are an environment with heightened risk of diagnostic error due to time and resource pressures, a frequently chaotic environment, and patients arriving undifferentiated and with minimal context. This project aimed to develop a behavioural, evidence-informed intervention to reduce diagnostic error in Emergency Departments through co-design with emergency physicians, insurers, researchers, hospital managers, citizens and consumer representatives. The Forum Process was utilised to address this aim. This involves convening a small (4 – 6 member) expert panel to guide a focused literature and practice review; convening of a 10 – 12 person citizens panel to gather perspectives of laypeople, including those affected by misdiagnoses; and a 18 – 22 person structured stakeholder dialogue bringing together representatives of the aforementioned stakeholder groups. The process not only provides in-depth analysis of the problem and associated behaviours, but brings together expertise and insight to facilitate identification of a behaviour change intervention. Informed by the literature and practice review, the Citizens Panel focused on eliciting the values and concerns of those affected or potentially affected by diagnostic error. Citizens were comfortable with diagnostic uncertainty if doctors were honest with them. They also emphasised the importance of open communication between doctors and patients and their families. Citizens expect more consistent standards across the state and better access for both patients and their doctors to patient health information to avoid time-consuming re-taking of long patient histories and medication regimes when re-presenting at Emergency Departments and to reduce the risk of unintentional omissions. The structured Stakeholder Dialogue focused on identifying a feasible behavioural intervention to review diagnoses in Emergency Departments. This needed to consider the role of cognitive bias in medical decision-making; contextual factors (in Victoria, there is a legislated 4-hour maximum time between ED triage and discharge / hospital admission); resource availability; and the need to ensure the intervention could work in large metropolitan as well as small rural and regional ED settings across Victoria. The identified behavioural intervention will be piloted in approximately ten hospital EDs across Victoria, Australia. This presentation will detail the findings of all review and consultation activities, describe the behavioural intervention developed and present results of the pilot trial.

Keywords: behavioural intervention, cognitive bias, decision-making, diagnostic error

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2040 Management of First Trimester Miscarriage

Authors: Madeleine Cox

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Objective; analyse patient choices in management of first trimester miscarriage, rates of complications including repeat procedure. Design: all first trimester miscarriages from a tertiary institution on the Gold Coast in a 6 month time frame (July to December 2021) were reviewed, including choice of management, histopathology, any representations or admissions, and potential complications. Results: a total of 224 first trimester miscarriages were identified. Of these, 183 (81%) opted to have surgical management in the first instance. Of the remaining patients, 18 (8%) opted to have medical management, and 28 (12.5%) opted to have expectant management. In total, 33(15%) patients required a repeat treatment for retained products. 1 had medical management for a small volume PROC post suction curette. A significant number of these patients initially opted for medical management but then elected to have shorter follow up than usual and went on to have retained products noted. 5 women who had small volumes of RPOC post medical or surgical management had repeat suction curette, however, had very small volumes of products on scan and on curette and may have had a good result with repeated misoprostol administration. It is important to note that whilst a common procedure, suction curettes are not without risk. 2 women had significant blood loss of 1L and 1.5L. A third women had a uterine perforation, a rare but recognised complication, she went on to require a laparoscopy which identified a small serosal bowel injury which was closed by the colorectal team. Conclusion: Management of first trimester miscarriage should be guided by patient preference. It is important to be able to provide patients with their choice of management, however, it is also important to have a good understanding of the risks of each management choice, chances of repeated procedure, appropriate time frame for follow up. Women who choose to undertake medical or expectant management should be supported through this time, with appropriate time frame between taking misoprostol and repeat scan so that the true effects can be evaluated. Patients returning for scans within 2-3 days are more likely to be booked for further surgery, however, may reflect patients who did not have adequate counselling or simply changed their mind on their preferred management options.

Keywords: miscarriage, gynaecology, obstetrics, first trimester

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2039 Clinical Trial of VEUPLEXᵀᴹ TBI Assay to Help Diagnose Traumatic Brain Injury by Quantifying Glial Fibrillary Acidic Protein and Ubiquitin Carboxy-Terminal Hydrolase L1 in the Serum of Patients Suspected of Mild TBI by Fluorescence Immunoassay

Authors: Moon Jung Kim, Guil Rhim

Abstract:

The clinical sensitivity of the “VEUPLEXTM TBI assay”, a clinical trial medical device, in mild traumatic brain injury was 28.6% (95% CI, 19.7%-37.5%), and the clinical specificity was 94.0% (95% CI, 89.3%). -98.7%). In addition, when the results analyzed by marker were put together, the sensitivity was higher when interpreting the two tests together than the two tests, UCHL1 and GFAP alone. Additionally, when sensitivity and specificity were analyzed based on CT results for the mild traumatic brain injury patient group, the clinical sensitivity for 2 CT-positive cases was 50.0% (95% CI: 1.3%-98.7%), and 19 CT-negative cases. The clinical specificity for cases was 68.4% (95% CI: 43.5% - 87.4%). Since the low clinical sensitivity for the two CT-positive cases was not statistically significant due to the small number of samples analyzed, it was judged necessary to secure and analyze more samples in the future. Regarding the clinical specificity analysis results for 19 CT-negative cases, there were a large number of patients who were actually clinically diagnosed with mild traumatic brain injury but actually received a CT-negative result, and about 31.6% of them showed abnormal results on VEUPLEXTM TBI assay. Although traumatic brain injury could not be detected in 31.6% of the CT scans, the possibility of actually suffering a mild brain injury could not be ruled out, so it was judged that this could be confirmed through follow-up observation of the patient. In addition, among patients with mild traumatic brain injury, CT examinations were not performed in many cases because the symptoms were very mild, but among these patients, about 25% or more showed abnormal results in the VEUPLEXTM TBI assay. In fact, no damage is observed with the naked eye immediately after traumatic brain injury, and traumatic brain injury is not observed even on CT. But in some cases, brain hemorrhage may occur (delayed cerebral hemorrhage) after a certain period of time, so the patients who did show abnormal results on VEUPLEXTM TBI assay should be followed up for the delayed cerebral hemorrhage. In conclusion, it was judged that it was difficult to judge mild traumatic brain injury with the VEUPLEXTM TBI assay only through clinical findings without CT results, that is, based on the GCS value. Even in the case of CT, it does not detect all mild traumatic brain injury, so it is difficult to necessarily judge that there is no traumatic brain injury, even if there is no evidence of traumatic brain injury in CT. And in the long term, more patients should be included to evaluate the usefulness of the VEUPLEXTM TBI assay in the detection of microscopic traumatic brain injuries without using CT.

Keywords: brain injury, traumatic brain injury, GFAP, UCHL1

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2038 A Case-Series Analysis of Tuberculosis in Patients at Internal Medicine Department

Authors: Cherif Y., Ghariani R., Derbal S., Farhati S., Ben Dahmen F., Abdallah M.

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Introduction: Tuberculosis (TBC) is a frequent infection and is still a major public health problem in Tunisia. The aim of this work is to focus on diagnostic and therapeutic characteristics of TBC in patients referred to our internal medicine department. Patients and Methods: The study was retrospective and descriptive of a cohort of consecutive cases treated from January 2016 to December 2019, collecting patients with latent or patent TBC. Twenty-eight medical records of adults diagnosed with TBC were reviewed. Results: Twenty-eight patients, including 18 women and 10 men, were diagnosed with TBC. Their mean age is 48 years (range: 22-78 years). Five patients have a medical history of diabetes mellitus, 1 patient was followed for systemic lupus erythematosus treated with corticosteroids and immunosuppressant drugs, and another was treated with corticosteroids for Mac Duffy syndrome. The TBC is latent in 12 cases and patent in 16 cases. The most common symptoms were fever and weight loss and were found in 10 cases, a cough in 2 cases, sputum in 3 cases, lymph nodes in 4 cases, erythema nodosum in 2 cases, and neurological signs in 3 cases. Lymphopenia is noticed in 3 cases and a biological inflammatory syndrome in 18 of the cases. The purified protein derivate reaction was positive in 17 cases, anergic in 3 cases, negative in 5 cases, and not done in 3 cases. The acid-fast bacilli stain culture was strongly positive in one patient. The histopathological study was conclusive in 11 patients and showed granulomatosis with caseous necrosis. TBC was pulmonary in 7 patients, lymph node in 7 cases, peritoneal in 7 cases, digestive in 1 case, neuromeningeal in 3 cases, and thyroïd in 1 case. Seven patients had multifocal TBC. All the patients received anti-tuberculosis treatment with a mean duration of 8 months with no failure or relapse with an average follow-up time of 10.58 months. Conclusion: Diagnosis and management of TBC remain essential to avoid serious complications. The survey is necessary to ensure timely detection and treatment of infected adults to decrease its incidence. The best treatment remains preventive through vaccination and improving social and economic conditions.

Keywords: tuberculosis, infection, autoimmune disease, granulomatosis

Procedia PDF Downloads 184
2037 Qualitative Analysis of Current Child Custody Evaluation Practices

Authors: Carolyn J. Ortega, Stephen E. Berger

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The role of the custody evaluator is perhaps one of the most controversial and risky endeavors in clinical practice. Complaints filed with licensing boards regarding a child-custody evaluation constitute the second most common reason for such an event. Although the evaluator is expected to answer for the family-law court what is in the “best interest of the child,” there is a lack of clarity on how to establish this in any empirically validated manner. Hence, practitioners must contend with a nebulous framework in formulating their methodological procedures that inherently places them at risk in an already litigious context. This study sought to qualitatively investigate patterns of practice among doctoral practitioners conducting child custody evaluations in the area of Southern California. Ten psychologists were interviewed who devoted between 25 and 100% of their California private practice to custody work. All held Ph.D. degrees with a range of eight to 36 years of experience in custody work. Semi-structured interviews were used to investigate assessment practices, ensure adherence to guidelines, risk management, and qualities of evaluators. Forty-three Specific Themes were identified using Interpretive Phenomenological Analysis (IPA). Seven Higher Order Themes clustered on salient factors such as use of Ethics, Law, Guidelines; Parent Variables; Child Variables; Psychologist Variables; Testing; Literature; and Trends. Evaluators were aware of the ever-present reality of a licensure complaint and thus presented idiosyncratic descriptions of risk management considerations. Ambiguity about quantifying and validly tapping parenting abilities was also reviewed. Findings from this study suggested a high reliance on unstructured and observational methods in child custody practices.

Keywords: forensic psychology, psychological testing, assessment methodology, child custody

Procedia PDF Downloads 281
2036 COVID-19 Infection in Children Admitted to Academic Hospitals in Central South Africa

Authors: Olive P. Khaliq, Stephen C. Brown, Boitumelo Pitso, Paeds Pulmo, Nomakhuwa E. Tabane

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Context: The research focuses on the prevalence of SARS-CoV-2 infection in hospitalized children during the Omicron variant wave in South Africa, specifically in the Free State Province. Research Aim: This study aimed to investigate the prevalence of COVID-19 infection in asymptomatic, unvaccinated children during the Omicron variant wave in the Free State Province of South Africa. Methods: A prospective cross-sectional study was conducted on children aged 0-12 admitted to hospitals using nucleocapsid antibody rapid testing for SARS-CoV-2 presence. Data on parent/caregiver vaccination and patient conditions were collected. Results: 46.8% of hospitalized children tested positive for SARS-CoV-2, with the highest rates in neonates. Most infected children had unrelated conditions and were asymptomatic. The Omicron variant was characterized as highly infectious but less virulent, leading to mild disease. Theoretical Importance: The study highlights the significant SARS-CoV-2 infection rates in hospitalized children during the Omicron variant surge, emphasizing the variant's unique characteristics in causing mild or asymptomatic infections. Data Collection: Data were collected through nucleocapsid antibody rapid testing for SARS-CoV-2 and the compilation of parent/caregiver vaccination status and patient conditions. Analysis Procedures: The data were analyzed to determine the prevalence of SARS-CoV-2 infection in hospitalized children, focusing on demographics, infection rates, and associated conditions. Questions Addressed: The study addressed the prevalence of SARS-CoV-2 in hospitalized children, the impact of the Omicron variant, the asymptomatic nature of infections, and the potential role of vaccination status in transmission. Conclusion: The research revealed a high rate of SARS-CoV-2 infections among hospitalized children, mostly asymptomatic and with unrelated conditions, indicating the unique infectiousness and clinical presentation of the Omicron variant in this demographic.

Keywords: SARS-CoV-2, Omicron variant, antibodies, children, admission diagnosis

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2035 A Novel Machine Learning Approach to Aid Agrammatism in Non-fluent Aphasia

Authors: Rohan Bhasin

Abstract:

Agrammatism in non-fluent Aphasia Cases can be defined as a language disorder wherein a patient can only use content words ( nouns, verbs and adjectives ) for communication and their speech is devoid of functional word types like conjunctions and articles, generating speech of with extremely rudimentary grammar . Past approaches involve Speech Therapy of some order with conversation analysis used to analyse pre-therapy speech patterns and qualitative changes in conversational behaviour after therapy. We describe this approach as a novel method to generate functional words (prepositions, articles, ) around content words ( nouns, verbs and adjectives ) using a combination of Natural Language Processing and Deep Learning algorithms. The applications of this approach can be used to assist communication. The approach the paper investigates is : LSTMs or Seq2Seq: A sequence2sequence approach (seq2seq) or LSTM would take in a sequence of inputs and output sequence. This approach needs a significant amount of training data, with each training data containing pairs such as (content words, complete sentence). We generate such data by starting with complete sentences from a text source, removing functional words to get just the content words. However, this approach would require a lot of training data to get a coherent input. The assumptions of this approach is that the content words received in the inputs of both text models are to be preserved, i.e, won't alter after the functional grammar is slotted in. This is a potential limit to cases of severe Agrammatism where such order might not be inherently correct. The applications of this approach can be used to assist communication mild Agrammatism in non-fluent Aphasia Cases. Thus by generating these function words around the content words, we can provide meaningful sentence options to the patient for articulate conversations. Thus our project translates the use case of generating sentences from content-specific words into an assistive technology for non-Fluent Aphasia Patients.

Keywords: aphasia, expressive aphasia, assistive algorithms, neurology, machine learning, natural language processing, language disorder, behaviour disorder, sequence to sequence, LSTM

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2034 Maternal Perception of Using Epidural Anesthesia and the Childbirth Outcomes

Authors: Jiyoung Kim, Chae Weon Chung

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Labor pain is one of the most common concerns of pregnant women, thus women are in need of possible options they could take to control the pain. So, this study aimed to explore maternal perception of epidural anesthesia and to compare the childbirth outcomes according to the use of epidural anesthesia. For this descriptive study, women who were over 36 weeks of pregnancy were recruited from an out-patient obstetric clinic in a public hospital in Seoul. Women were included in the study if agreed to participate, were pregnant singleton, without pregnancy complication, and expecting a natural birth. Data collection was done twice, the first one at the prenatal care visit and the second one at an in-patient ward on 2nd day postpartum. The instrument of the beliefs about epidural anesthesia, one item of asking intention to use epidural anesthesia, demographics, and obstetrical characteristics were incorporated into a questionnaire. One nurse researcher performed data collection with the structured questionnaire after the approval of the institutional review board. At the initial data collection 133 women were included, while 117 were retained at the second point after excluded 13 women due to the occurrence of complications. Analyses were done by chi-square, t-test, and ANOVA using the SPSS program. Women were aged 32.5 years old, 22.2% were over 35 years old. The average gestational age was 38.5 weeks, and 67.5% were nulliparous. Out of 38 multiparous women, 20 women (52.6%) had received epidural anesthesia in the previous delivery. At the initial interview, 62.6% (n=73) of women wanted to receive epidural anesthesia while 22.4% answered not decided and 15.4% did not want to take the procedure. However, there were changes in proportions between women’s intention to take it and actual procedures done, particularly, two-thirds of women (n=26) who had been undecided were found to receive epidural anesthesia during labor. There was a significant difference in the perception of epidural anesthesia measured before delivery between women who received and not received it (t=3.68, p < .001). Delivery outcomes were statistically different between the two groups in delivery mode (chi-square=8.64, p=.01), O₂ supply during labor (chi-square =5.01, p=.03), duration of 2nd stage of labor (t=3.70, p < .001), and arterial cord blood pH (t=2.64, p=.01). Interestingly, there was no difference in labor pain perceived between women with and without epidural anesthesia. Considering the preference and use of epidural anesthesia, health professionals need to assess coping ability of women undergoing delivery and to provide accurate information about pain control to support their decision making and eventually to enhance delivery outcomes for mothers and neonates.

Keywords: epidural anesthesia, delivery outcomes, labor pain, perception

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2033 Multi-Plane Wrist Movement: Pathomechanics and Design of a 3D-Printed Splint

Authors: Sigal Portnoy, Yael Kaufman-Cohen, Yafa Levanon

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Introduction: Rehabilitation following wrist fractures often includes exercising flexion-extension movements with a dynamic splint. However, during daily activities, we combine most of our wrist movements with radial and ulnar deviations. Also, the multi-plane wrist motion, named the ‘dart throw motion’ (DTM), was found to be a more stable motion in healthy individuals, in term of the motion of the proximal carpal bones, compared with sagittal wrist motion. The aim of this study was therefore to explore the pathomechanics of the wrist in a common multi-plane movement pattern (DTM) and design a novel splint for rehabilitation following distal radius fractures. Methods: First, a multi-axis electro-goniometer was used to quantify the plane angle of motion of the dominant and non-dominant wrists during various activities, e.g. drinking from a glass of water and answering a phone in 43 healthy individuals. The following protocols were then implemented with a population following distal radius fracture. Two dynamic scans were performed, one of the sagittal wrist motion and DTM, in a 3T magnetic resonance imaging (MRI) device, bilaterally. The scaphoid and lunate carpal bones, as well as the surface of the distal radius, were manually-segmented in SolidWorks and the angles of motion of the scaphoid and lunate bones were calculated. Subsequently, a patient-specific splint was designed using 3D scans of the hand. The brace design comprises of a proximal attachment to the arm and a distal envelope of the palm. An axle with two wheels is attached to the proximal part. Two wires attach the proximal part with the medial-palmar and lateral-ventral aspects of the distal part: when the wrist extends, the first wire is released and the second wire is strained towards the radius. The opposite occurs when the wrist flexes. The splint was attached to the wrist using Velcro and constrained the wrist movement to the desired calculated multi-plane of motion. Results: No significant differences were found between the multi-plane angles of the dominant and non-dominant wrists. The most common daily activities occurred at a plane angle of approximately 20° to 45° from the sagittal plane and the MRI studies show individual angles of the plane of motion. The printed splint fitted the wrist of the subjects and constricted movement to the desired multi-plane of motion. Hooks were inserted on each part to allow the addition of springs or rubber bands for resistance training towards muscle strengthening in the rehabilitation setting. Conclusions: It has been hypothesized that activation of the wrist in a multi-plane movement pattern following distal radius fractures will accelerate the recovery of the patient. Our results show that this motion can be determined from either the dominant or non-dominant wrists. The design of the patient-specific dynamic splint is the first step towards assessing whether splinting to induce combined movement is beneficial to the rehabilitation process, compared to conventional treatment. The evaluation of the clinical benefits of this method, compared to conventional rehabilitation methods following wrist fracture, are a part of a PhD work, currently conducted by an occupational therapist.

Keywords: distal radius fracture, rehabilitation, dynamic magnetic resonance imaging, dart throw motion

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2032 Risk Management Approach for a Secure and Performant Integration of Automated Drug Dispensing Systems in Hospitals

Authors: Hind Bouami, Patrick Millot

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Medication dispensing system is a life-critical system whose failure may result in preventable adverse events leading to longer patient stays in hospitals or patient death. Automation has led to great improvements in life-critical systems as it increased safety, efficiency, and comfort. However, critical risks related to medical organization complexity and automated solutions integration can threaten drug dispensing security and performance. Knowledge about the system’s complexity aspects and human machine parameters to control for automated equipment’s security and performance will help operators to secure their automation process and to optimize their system’s reliability. In this context, this study aims to document the operator’s situation awareness about automation risks and parameters involved in automation security and performance. Our risk management approach has been deployed in the North Luxembourg hospital center’s pharmacy, which is equipped with automated drug dispensing systems since 2009. With more than 4 million euros of gains generated, North Luxembourg hospital center’s success story was enabled by the management commitment, pharmacy’s involvement in the implementation and improvement of the automation project, and the close collaboration between the pharmacy and Sinteco’s firm to implement the necessary innovation and organizational actions for automated solutions integration security and performance. An analysis of the actions implemented by the hospital and the parameters involved in automated equipment’s integration security and performance has been made. The parameters to control for automated equipment’s integration security and performance are human aspects (6.25%), technical aspects (50%), and human-machine interaction (43.75%). The implementation of an anthropocentric analysis system before automation would have prevented and optimized the control of risks related to automation.

Keywords: Automated drug delivery systems, Hospitals, Human-centered automated system, Risk management

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2031 Scientific and Regulatory Challenges of Advanced Therapy Medicinal Products

Authors: Alaa Abdellatif, Gabrièle Breda

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Background. Advanced therapy medicinal products (ATMPs) are innovative therapies that mainly target orphan diseases and high unmet medical needs. ATMP includes gene therapy medicinal products (GTMP), somatic cell therapy medicinal products (CTMP), and tissue-engineered therapies (TEP). Since legislation opened the way in 2007, 25 ATMPs have been approved in the EU, which is about the same amount as the U.S. Food and Drug Administration. However, not all of the ATMPs that have been approved have successfully reached the market and retained their approval. Objectives. We aim to understand all the factors limiting the market access to very promising therapies in a systemic approach, to be able to overcome these problems, in the future, with scientific, regulatory and commercial innovations. Further to recent reviews that focus either on specific countries, products, or dimensions, we will address all the challenges faced by ATMP development today. Methodology. We used mixed methods and a multi-level approach for data collection. First, we performed an updated academic literature review on ATMP development and their scientific and market access challenges (papers published between 2018 and April 2023). Second, we analyzed industry feedback from cell and gene therapy webinars and white papers published by providers and pharmaceutical industries. Finally, we established a comparative analysis of the regulatory guidelines published by EMA and the FDA for ATMP approval. Results: The main challenges in bringing these therapies to market are the high development costs. Developing ATMPs is expensive due to the need for specialized manufacturing processes. Furthermore, the regulatory pathways for ATMPs are often complex and can vary between countries, making it challenging to obtain approval and ensure compliance with different regulations. As a result of the high costs associated with ATMPs, challenges in obtaining reimbursement from healthcare payers lead to limited patient access to these treatments. ATMPs are often developed for orphan diseases, which means that the patient population is limited for clinical trials which can make it challenging to demonstrate their safety and efficacy. In addition, the complex manufacturing processes required for ATMPs can make it challenging to scale up production to meet demand, which can limit their availability and increase costs. Finally, ATMPs face safety and efficacy challenges: dangerous adverse events of these therapies like toxicity related to the use of viral vectors or cell therapy, starting material and donor-related aspects. Conclusion. As a result of our mixed method analysis, we found that ATMPs face a number of challenges in their development, regulatory approval, and commercialization and that addressing these challenges requires collaboration between industry, regulators, healthcare providers, and patient groups. This first analysis will help us to address, for each challenge, proper and innovative solution(s) in order to increase the number of ATMPs approved and reach the patients

Keywords: advanced therapy medicinal products (ATMPs), product development, market access, innovation

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2030 Relationship Between tcdA and tcdB Genes of Clostridium difficile with Duration of Diarrhea in Elderly Patients

Authors: Ni Luh Putu Harta Wedari

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Background: Clostridium difficile has two main virulence factors, namely TcdA and TcdB. TcdA encoded by the tcdA gene acts as an enterotoxin, pro-inflammatory and fluid accumulation, while TcdB encoded by the tcdB gene is cytotoxic, causes disruption of the actin cytoskeleton, and causes disruption of tight junctions in colon cells. This study aims to explore the relationship between the tcdA and tcdB genes and the duration of diarrhea in elderly patients. Method: This research was an observational analytic with a prospective cross-sectional with samples of elderly diarrhea patients who met the inclusion criteria in Denpasar City health service facilities from 1 December 2022 until 30 June 2023, and then their feces were analyzed using the real-time PCR method. Results: In this study, 40 elderly diarrhea patients met the inclusion criteria and in accordance with the minimum sample size, 28 (70%) men and 12 (30%) women. 5 patients (12.5%) had a history of azithromycin, 4 (10%) levofloxacin, 17 (42.5%) ciprofloxacin, 8 (20%) metronidazole, 1 (2.5%) cefoperazone, 5 (12, 5%) doxycycline. Comorbids, namely 13 (32.5%) type II diabetes mellitus, 4 (10%) chronic kidney disease, 10 (25%) malignancies, 7 (17.5%) urinary tract infections, 3 (7.5%) %) immunocompromised, 2 (5%) cardiac heart failure, and 1 (2.5%) acute on chronic kidney disease. The overall diarrhea duration average was 5 days. 8 samples (20%) were positive for 16s rRNA, and there was no significant difference in diarrhea duration with negative samples (p=0.166). The relationship between the tcdA gene and the duration of diarrhea could not be performed because all samples were negative. Likewise, relationship analysis between the coexistence of tcdA and tcdB could not be performed. There was no significant difference between tcdB positive 3 (7.5%) and negative with diarrhea duration (p=0.739). Conclusion: There is no significant relationship between the presence of the 16s rRNA and tcdB C. difficile genes with the duration of diarrhea in elderly patients.

Keywords: clostridium, difficile, diarrhea, elderly, tcdA, tcdB

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2029 The Effect of Expanding the Early Pregnancy Assessment Clinic and COVID-19 on Emergency Department and Urgent Care Visits for Early Pregnancy Bleeding

Authors: Harley Bray, Helen Pymar, Michelle Liu, Chau Pham, Tomislav Jelic, Fran Mulhall

Abstract:

Background: Our study assesses the impact of the COVID-19 pandemic on early pregnancy assessment clinic (EPAC) referrals and the use of virtual consultation in Winnipeg, Manitoba. Our clinic expanded to accept referrals from all Winnipeg Emergency Department (ED)/Urgent Care (UC) sites beginning November 2019 to April 2020. By May 2020, the COVID-19 pandemic reached Manitoba and EPAC virtual care was expanded by performing hCG remotely and reviewing blood and ED/UC ultrasound results by phone. Methods: Emergency Department Information Systems (EDIS) and EPAC data reviewed ED/UC visits for pregnancy <20 weeks and vaginal bleeding 1-year pre-COVID (March 12, 2019, to March 11, 2020) and during COVID (March 12, 2020 (first case in Manitoba) to March 11, 2021). Results: There were fewer patient visits for vaginal bleeding or pregnancy of <20 weeks (4264 vs. 5180), diagnoses of threatened abortion (1895 vs. 2283), and ectopic pregnancy (78 vs. 97) during COVID compared with pre-COVID, respectively. ICD 10 codes were missing in 849 (20%) and 1183 (23%) of patients during COVID and pre-COVID, respectively. Wait times for all patient visits improved during COVID-19 compared to pre-COVID (5.1 ± 4.4 hours vs. 5.5 ± 3.8 hours), more patients received obstetrical ultrasounds, 761 (18%) vs. 787 (15%), and fewer patients returned within 30 days (1360 (32%) vs. 1848 (36%); p<0.01). EPAC saw 708 patients (218; 31% new ED/UC) during COVID-19 compared to 552 (37; 7% new ED/UC) pre-COVID. Fewer operative interventions for pregnancy loss (346 vs. 456) and retained products (236 vs. 272) were noted. Surgeries to treat ectopic pregnancy (106 vs 113) remained stable during the study time interval. Conclusion: Accurate identification of pregnancy complications was difficult, with over 20% missing ICD-10 diagnostic codes. There were fewer ED/UC visits and surgical management for threatened abortion during COVID-19, but ectopic pregnancy operative management remained unchanged.

Keywords: early pregnancy, ultrasound, COVID-19, obstetrics

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2028 Effect of the Diverse Standardized Patient Simulation Cultural Competence Education Strategy on Nursing Students' Transcultural Self-Efficacy Perceptions

Authors: Eda Ozkara San

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Nurse educators have been charged by several nursing organizations and accrediting bodies to provide innovative and evidence-based educational experiences, both didactic and clinical, to help students to develop the knowledge, skills, and attitudes needed to provide culturally competent nursing care to patients. Clinical simulation, which offers the opportunity for students to practice nursing skills in a risk-free, controlled environment and helps develop self-efficacy (confidence) within the nursing role. As one simulation method, the standardized patients (SPs) simulation helps educators to teach nursing students variety of skills in nursing, medicine, and other health professions. It can be a helpful tool for nurse educators to enhance cultural competence of nursing students. An alarming gap exists within the literature concerning the effectiveness of SP strategy to enhance cultural competence development of diverse student groups, who must work with patients from various backgrounds. This grant-supported, longitudinal, one-group, pretest and post-test educational intervention study aimed to examine the effect of the Diverse Standardized Patient Simulation (DSPS) cultural competence education strategy on students’ (n = 53) transcultural self-efficacy (TSE). The researcher-developed multidimensional DSPS strategy involved careful integration of transcultural nursing skills guided by the Cultural Competence and Confidence (CCC) model. As a carefully orchestrated teaching and learning strategy by specifically utilizing the SP pedagogy, the DSPS also followed international guidelines and standards for the design, implementation, evaluation, and SP training; and had content validity review. The DSPS strategy involved two simulation scenarios targeting underrepresented patient populations (Muslim immigrant woman with limited English proficiency and Irish-Italian American gay man with his partner (Puerto Rican) to be utilized in a second-semester, nine-credit, 15-week medical-surgical nursing course at an urban public US university. Five doctorally prepared content experts reviewed the DSPS strategy for content validity. The item-level content validity index (I-CVI) score was calculated between .80-1.0 on the evaluation forms. Jeffreys’ Transcultural Self-Efficacy Tool (TSET) was administered as a pretest and post-test to assess students’ changes in cognitive, practical, and affective dimensions of TSE. Results gained from this study support that the DSPS cultural competence education strategy assisted students to develop cultural competence and caused statistically significant changes (increase) in students’ TSE perceptions. Results also supported that all students, regardless of their background, benefit (and require) well designed cultural competence education strategies. The multidimensional DSPS strategy is found to be an effective way to foster nursing students’ cultural competence development. Step-by-step description of the DSPS provides an easy adaptation of this strategy with different student populations and settings.

Keywords: cultural competence development, the cultural competence and confidence model, CCC model, educational intervention, transcultural self-efficacy, TSE, transcultural self-efficacy tool, TSET

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2027 Psychometric Properties of the Eq-5d-3l and Eq-5d-5l Instruments for Health Related Quality of Life Measurement in Indonesian Population

Authors: Dwi Endarti, Susi a Kristina, Rizki Noorizzati, Akbar E Nugraha, Fera Maharani, Kika a Putri, Asninda H Azizah, Sausanzahra Angganisaputri, Yunisa Yustikarini

Abstract:

Cost utility analysis is the most recommended pharmacoeconomic method since it allows widely comparison of cost-effectiveness results from different interventions. The method uses outcome of quality-adjusted life year (QALY) or disability-adjusted life year (DALY). Measurement of QALY requires the data of utility dan life years gained. Utility is measured with the instrument for quality of life measurement such as EQ-5D. Recently, the EQ-5D is available in two versions which are EQ-5D-3L and EQ-5D-5L. This study aimed to compare the EQ-5D-3L and EQ-5D-5L to examine the most suitable version for Indonesian population. This study was an observational study employing cross sectional approach. Data of quality of life measured with EQ-5D-3L and EQ-5D-5L were collected from several groups of population which were respondent with chronic diseases, respondent with acute diseases, and respondent from general population (without illness) in Yogyakarta Municipality, Indonesia. Convenience samples of hypertension patients (83), diabetes mellitus patients (80), and osteoarthritis patients (47), acute respiratory tract infection (81), cephalgia (43), dyspepsia (42), and respondent from general population (293) were recruited in this study. Responses on the 3L and 5L versions of EQ-5D were compared by examining the psychometric properties including agreement, internal consistency, ceiling effect, and convergent validity. Based on psychometric properties tests of EQ-5D-3L dan EQ-5D-5L, EQ-5D-5L tended to have better psychometric properties compared to EQ-5D-3L. Future studies for health related quality of life (HRQOL) measurements for pharmacoeconomic studies in Indonesia should apply EQ-5D-5L.

Keywords: EQ-5D, Health Related Quality of Life, Indonesian Population, Psychometric Properties

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2026 History of Recurrent Mucosal Infections and Immune System Disorders Is Related to Complications of Non-infectious Anterior Uveitis

Authors: Barbara Torres Rives

Abstract:

Uveitis. Non-infectious anterior uveitis is a polygenic inflammatory eye disease, and it is suggested that mediated processes by the immune system (autoimmune or not) are the main mechanisms proposed in the pathogenesis of this type of uveitis. A relationship between infectious processes, digestive disorders, and a dysbiosis of the microbiome was recently described. In addition, alterations in the immune response associated with the initiation and progression of the disease have been described. Objective: The aim of this study was to identify factors related to the immune system associated with complicated non-infectious anterior uveitis. Methods: A cross-sectional observational analytical study was carried out. The universe consisted of all patients attending the ocular inflammation service of the Cuban Institute of Ophthalmology Ramón Pando Ferrer. The sample consisted of 213 patients diagnosed with non-infectious anterior uveitis. Results: Of the 213 patients with non-infectious anterior uveitis, the development of ophthalmologic complications predominated 56.3% (p=0.0094). In patients with complications was more frequent the presence of human leukocyte antigen-B27 allele (49.2%) (p<0.0001), decreased immunoglobulin G (24.2%, p=0.0124), increased immunoglobulin A (14.2%, p=0.0024), history of recurrent sepsis (59.2%, p=0.0018), recurrent respiratory infections (44.2%, p=0.0003), digestive alterations (40%, p=0.0013) and spondyloarthropathies (30%, p=0.0314). By logistic regression, it was observed that, for each completed year, the elevated risk for developing complicated non-infectious anterior uveitis in human leukocyte antigen-B27 allele positive patients (OR: 4.22, p=0.000), Conclusions: The control of recurrent sepsis at mucosal level and immunomodulation could prevent complications in non-infectious anterior uveitis. Therefore, the microbiome becomes the target of treatment and prevention of complications in non-infectious anterior uveitis.

Keywords: non-infectious anterior uveitis, immune system disorders, recurrent mucosal infections, microbiome

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