Search results for: minimal invasive surgery
Commenced in January 2007
Frequency: Monthly
Edition: International
Paper Count: 2401

Search results for: minimal invasive surgery

121 Internal Mercury Exposure Levels Correlated to DNA Methylation of Imprinting Gene H19 in Human Sperm of Reproductive-Aged Man

Authors: Zhaoxu Lu, Yufeng Ma, Linying Gao, Li Wang, Mei Qiang

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Mercury (Hg) is a well-recognized environmental pollutant known by its toxicity of development and neurotoxicity, which may result in adverse health outcomes. However, the mechanisms underlying the teratogenic effects of Hg are not well understood. Imprinting genes are emerging regulators for fetal development subject to environmental pollutants impacts. In this study, we examined the association between paternal preconception Hg exposures and the alteration of DNA methylation of imprinting genes in human sperm DNA. A total of 618 men aged from 22 to 59 was recruited from the Reproductive Medicine Clinic of Maternal and Child Care Service Center and the Urologic Surgery Clinic of Shanxi Academy of Medical Sciences during April 2015 and March 2016. Demographic information was collected using questionnaires. Urinary Hg concentrations were measured using a fully-automatic double-channel hydride generation atomic fluorescence spectrometer. And methylation status in the DMRs of imprinting genes H19, Meg3 and Peg3 of sperm DNA were examined by bisulfite pyrosequencing in 243 participants. Spearman’s rank and multivariate regression analysis were used for correlation analysis between sperm DNA methylation status of imprinting genes and urinary Hg levels. The median concentration of Hg for participants overall was 9.09μg/l (IQR: 5.54 - 12.52μg/l; range = 0 - 71.35μg/l); no significant difference was found in median concentrations of Hg among various demographic groups (p > 0.05). The proportion of samples that a beyond intoxication criterion (10μg/l) for urinary Hg was 42.6%. Spearman’s rank correlation analysis indicates a negative correlation between urinary Hg concentrations and average DNA methylation levels in the DMRs of imprinted genes H19 (rs=﹣0.330, p = 0.000). However, there was no such a correlation found in genes of Peg3 and Meg3. Further, we analyzed of correlation between methylation level at each CpG site of H19 and Hg level, the results showed that three out of 7 CpG sites on H19 DMR, namely CpG2 (rs =﹣0.138, p = 0.031), CpG4 (rs =﹣0.369, p = 0.000) and CpG6 (rs=﹣0.228, p = 0.000), demonstrated a significant negative correlation between methylation levels and the levels of urinary Hg. After adjusting age, smoking, drinking, intake of aquatic products and education by multivariate regression analysis, the results have shown a similar correlation. In summary, mercury nonoccupational environmental exposure in reproductive-aged men associated with altered DNA methylation outcomes at DMR of imprinting gene H19 in sperm, implicating the susceptibility of the developing sperm for environmental insults.

Keywords: epigenetics, genomic imprinting gene, DNA methylation, mercury, transgenerational effects, sperm

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120 The Perspective of British Politicians on English Identity: Qualitative Study of Parliamentary Debates, Blogs, and Interviews

Authors: Victoria Crynes

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The question of England’s role in Britain is increasingly relevant due to the ongoing rise in citizens identifying as English. Furthermore, the Brexit Referendum was predominantly supported by constituents identifying as English. Few politicians appear to comprehend how Englishness is politically manifested. Politics and the media have depicted English identity as a negative and extremist problem - an inaccurate representation that ignores the breadth of English identifying citizens. This environment prompts the question, 'How are British Politicians Addressing the Modern English Identity Question?' Parliamentary debates, political blogs, and interviews are synthesized to establish a more coherent understanding of the current political attitudes towards English identity, the perceived nature of English identity, and the political manifestation of English representation and governance. Analyzed parliamentary debates addressed the democratic structure of English governance through topics such as English votes for English laws, devolution, and the union. The blogs examined include party-based, multi-author style blogs, and independently authored blogs by politicians, which provide a dynamic and up-to-date representation of party and politician viewpoints. Lastly, fourteen semi-structured interviews of British politicians provide a nuanced perspective on how politicians conceptualize Englishness. Interviewee selection was based on three criteria: (i) Members of Parliament (MP) known for discussing English identity politics, (ii) MPs of strongly English identifying constituencies, (iii) MPs with minimal English identity affiliation. Analysis of parliamentary debates reveals the discussion of English representation has gained little momentum. Many politicians fail to comprehend who the English are, why they desire greater representation and believe that increased recognition of the English would disrupt the unity of the UK. These debates highlight the disconnect of parliament from the disenfranchised English towns. A failure to recognize the legitimacy of English identity politics generates an inability for solution-focused debates to occur. Political blogs demonstrate cross-party recognition of growing English disenfranchisement. The dissatisfaction with British politics derives from multiple factors, including economic decline, shifting community structures, and the delay of Brexit. The left-behind communities have seen little response from Westminster, which is often contrasted to the devolved and louder voices of the other UK nations. Many blogs recognize the need for a political response to the English and lament the lack of party-level initiatives. In comparison, interviews depict an array of local-level initiatives reconnecting MPs to community members. Local efforts include town trips to Westminster, multi-cultural cooking classes, and English language courses. These efforts begin to rebuild positive, local narratives, promote engagement across community sectors, and acknowledge the English voices. These interviewees called for large-scale, political action. Meanwhile, several interviewees denied the saliency of English identity. For them, the term held only extremist narratives. The multi-level analysis reveals continued uncertainty on Englishness within British politics, contrasted with increased recognition of its saliency by politicians. It is paramount that politicians increase discussions on English identity politics to avoid increased alienation of English citizens and to rebuild trust in the abilities of Westminster.

Keywords: British politics, contemporary identity politics and its impacts, English identity, English nationalism, identity politics

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119 Significant Factor of Magnetic Resonance for Survival Outcome in Rectal Cancer Patients Following Neoadjuvant Combined Chemotherapy and Radiation Therapy: Stratification of Lateral Pelvic Lymph Node

Authors: Min Ju Kim, Beom Jin Park, Deuk Jae Sung, Na Yeon Han, Kichoon Sim

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Purpose: The purpose of this study is to determine the significant magnetic resonance (MR) imaging factors of lateral pelvic lymph node (LPLN) on the assessment of survival outcomes of neoadjuvant combined chemotherapy and radiation therapy (CRT) in patients with mid/low rectal cancer. Materials and Methods: The institutional review board approved this retrospective study of 63 patients with mid/low rectal cancer who underwent MR before and after CRT and patient consent was not required. Surgery performed within 4 weeks after CRT. The location of LPLNs was divided into following four groups; 1) common iliac, 2) external iliac, 3) obturator, and 4) internal iliac lymph nodes. The short and long axis diameters, numbers, shape (ovoid vs round), signal intensity (homogenous vs heterogenous), margin (smooth vs irregular), and diffusion-weighted restriction of LPLN were analyzed on pre- and post-CRT images. For treatment response using size, lymph node groups were defined as group 1) short axis diameter ≤ 5mm on both MR, group 2) > 5mm change into ≤ 5mm after CRT, and group 3) persistent size > 5mm before and after CRT. Clinical findings were also evaluated. The disease-free survival and overall survival rate were evaluated and the risk factors for survival outcomes were analyzed using cox regression analysis. Results: Patients in the group 3 (persistent size >5mm) showed significantly lower survival rates than the group 1 and 2 (Disease-free survival rates of 36.1% and 78.8, 88.8%, p < 0.001). The size response (group 1-3), multiplicity of LPLN, the level of carcinoembryonic antigen (CEA), patient’s age, T and N stage, vessel invasion, perineural invasion were significant factors affecting disease-free survival rate or overall survival rate using univariate analysis (p < 0.05). The persistent size (group 3) and multiplicity of LPLN were independent risk factors among MR imaging features influencing disease-free survival rate (HR = 10.087, p < 0.05; HR = 4.808, p < 0.05). Perineural invasion and T stage were shown as independent histologic risk factors (HR = 16.594, p < 0.05; HR = 15.891, p < 0.05). Conclusion: The persistent size greater than 5mm and multiplicity of LPLN on both pre- and post-MR after CRT were significant MR factors affecting survival outcomes in the patients with mid/low rectal cancer.

Keywords: rectal cancer, MRI, lymph node, combined chemoradiotherapy

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118 Holistic Urban Development: Incorporating Both Global and Local Optimization

Authors: Christoph Opperer

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The rapid urbanization of modern societies and the need for sustainable urban development demand innovative solutions that meet both individual and collective needs while addressing environmental concerns. To address these challenges, this paper presents a study that explores the potential of spatial and energetic/ecological optimization to enhance the performance of urban settlements, focusing on both architectural and urban scales. The study focuses on the application of biological principles and self-organization processes in urban planning and design, aiming to achieve a balance between ecological performance, architectural quality, and individual living conditions. The research adopts a case study approach, focusing on a 10-hectare brownfield site in the south of Vienna. The site is surrounded by a small-scale built environment as an appropriate starting point for the research and design process. However, the selected urban form is not a prerequisite for the proposed design methodology, as the findings can be applied to various urban forms and densities. The methodology used in this research involves dividing the overall building mass and program into individual small housing units. A computational model has been developed to optimize the distribution of these units, considering factors such as solar exposure/radiation, views, privacy, proximity to sources of disturbance (such as noise), and minimal internal circulation areas. The model also ensures that existing vegetation and buildings on the site are preserved and incorporated into the optimization and design process. The model allows for simultaneous optimization at two scales, architectural and urban design, which have traditionally been addressed sequentially. This holistic design approach leads to individual and collective benefits, resulting in urban environments that foster a balance between ecology and architectural quality. The results of the optimization process demonstrate a seemingly random distribution of housing units that, in fact, is a densified hybrid between traditional garden settlements and allotment settlements. This urban typology is selected due to its compatibility with the surrounding urban context, although the presented methodology can be extended to other forms of urban development and density levels. The benefits of this approach are threefold. First, it allows for the determination of ideal housing distribution that optimizes solar radiation for each building density level, essentially extending the concept of sustainable building to the urban scale. Second, the method enhances living quality by considering the orientation and positioning of individual functions within each housing unit, achieving optimal views and privacy. Third, the algorithm's flexibility and robustness facilitate the efficient implementation of urban development with various stakeholders, architects, and construction companies without compromising its performance. The core of the research is the application of global and local optimization strategies to create efficient design solutions. By considering both, the performance of individual units and the collective performance of the urban aggregation, we ensure an optimal balance between private and communal benefits. By promoting a holistic understanding of urban ecology and integrating advanced optimization strategies, our methodology offers a sustainable and efficient solution to the challenges of modern urbanization.

Keywords: sustainable development, self-organization, ecological performance, solar radiation and exposure, daylight, visibility, accessibility, spatial distribution, local and global optimization

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117 An Observational Study Assessing the Baseline Communication Behaviors among Healthcare Professionals in an Inpatient Setting in Singapore

Authors: Pin Yu Chen, Puay Chuan Lee, Yu Jen Loo, Ju Xia Zhang, Deborah Teo, Jack Wei Chieh Tan, Biauw Chi Ong

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Background: Synchronous communication, such as telephone calls, remains the standard communication method between nurses and other healthcare professionals in Singapore public hospitals despite advances in asynchronous technological platforms, such as instant messaging. Although miscommunication is one of the most common causes of lapses in patient care, there is a scarcity of research characterizing baseline inter-professional healthcare communications in a hospital setting due to logistic difficulties. Objective: This study aims to characterize the frequency and patterns of communication behaviours among healthcare professionals. Methods: The one-week observational study was conducted on Monday through Sunday at the nursing station of a cardiovascular medicine and cardiothoracic surgery inpatient ward at the National Heart Centre Singapore. Subjects were shadowed by two physicians for sixteen hours or consecutive morning and afternoon nursing shifts. Communications were logged and characterized by type, duration, caller, and recipient. Results: A total of 1,023 communication events involving the attempted use of the common telephones at the nursing station were logged over a period of one week, corresponding to a frequency of one event every 5.45 minutes (SD 6.98, range 0-56 minutes). Nurses initiated the highest proportion of outbound calls (38.7%) via the nursing station common phone. A total of 179 face-to-face communications (17.5%), 362 inbound calls (35.39%), 481 outbound calls (47.02%), and 1 emergency alert (0.10%) were captured. Average response time for task-oriented communications was 159 minutes (SD 387.6, range 86-231). Approximately 1 in 3 communications captured aimed to clarify patient-related information. The total duration of time spent on synchronous communication events over one week, calculated from total inbound and outbound calls, was estimated to be a total of 7 hours. Conclusion: The results of our study showed that there is a significant amount of time spent on inter-professional healthcare communications via synchronous channels. Integration of patient-related information and use of asynchronous communication channels may help to reduce the redundancy of communications and clarifications. Future studies should explore the use of asynchronous mobile platforms to address the inefficiencies observed in healthcare communications.

Keywords: healthcare communication, healthcare management, nursing, qualitative observational study

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116 Suture Biomaterials Development from Natural Fibers: Muga Silk (Antheraea assama) and Ramie (Boehmeria nivea)

Authors: Raghuram Kandimalla, Sanjeeb Kalita, Bhaswati Choudhury, Jibon Kotoky

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The quest for developing an ideal suture material prompted our interest to develop a novel suture with advantageous characteristics to market available ones. We developed novel suture biomaterial from muga silk (Antheraea assama) and ramie (Boehmeria nivea) plant fiber. Field emission scanning electron microscopy (FE-SEM), energy-dispersive X-ray spectroscopy (EDX), attenuated total reflection fourier transform infrared spectroscopy (ATR-FTIR) and thermo gravimetric analysis (TGA) results revealed the physicochemical properties of the fibers which supports the suitability of fibers for suture fabrication. Tensile properties of the prepared sutures were comparable with market available sutures and it found to be biocompatible towards human erythrocytes and nontoxic to mammalian cells. The prepared sutures completely healed the superficial deep wound incisions within seven days in adult male wister rats leaving no rash and scar. Histopathology studies supports the wound healing ability of sutures, as rapid synthesis of collagen, connective tissue and other skin adnexal structures were observed within seven days of surgery. Further muga suture surface modified by exposing the suture to oxygen plasma which resulted in formation of nanotopography on suture surface. Broad spectrum antibiotic amoxicillin was functionalized on the suture surface to prepare an advanced antimicrobial muga suture. Surface hydrophilicity induced by oxygen plasma results in an increase in drug-impregnation efficiency of modified muga suture by 16.7%. In vitro drug release profiles showed continuous and prolonged release of amoxicillin from suture up to 336 hours. The advanced muga suture proves to be effective against growth inhibition of Staphylococcus aureus and Escherichia coli, whereas normal muga suture offers no antibacterial activity against both types of bacteria. In vivo histopathology studies and colony-forming unit count data revealed accelerated wound healing activity of advanced suture over normal one through rapid synthesis and proliferation of collagen, hair follicle and connective tissues.

Keywords: sutures, biomaterials, silk, Ramie

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115 Clinico-pathological Study of Xeroderma Pigmentosa: A Case Series of Eight Cases

Authors: Kakali Roy, Sahana P. Raju, Subhra Dhar, Sandipan Dhar

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Introduction: Xeroderma pigmentosa (XP) is a rare inherited (autosomal recessive) disease resulting from impairment in DNA repair that involves recognition and repair of ultraviolet radiation (UVR) induced DNA damage in the nucleotide excision repair pathway. Which results in increased photosensitivity, UVR induced damage to skin and eye, increased susceptibility of skin and ocular cancer, and progressive neurodegeneration in some patients. XP is present worldwide, with higher incidence in areas having frequent consanguinity. Being extremely rare, there is limited literature on XP and associated complications. Here, the clinico-pathological experience (spectrum of clinical presentation, histopathological findings of malignant skin lesions, and progression) of managing 8 cases of XP is presented. Methodology: A retrospective study was conducted in a pediatric tertiary care hospital in eastern India during a ten-year period from 2013 to 2022. A clinical diagnosis was made based on severe sun burn or premature photo-aging and/or onset of cutaneous malignancies at early age (1st decade) in background of consanguinity and autosomal recessive inheritance pattern in family. Results: The mean age of presentation was 1.2 years (range of 7month-3years), while three children presented during their infancy. Male to female ratio was 5:3, and all were born of consanguineous marriage. They presented with dermatological manifestations (100%) followed by ophthalmic (75%) and/or neurological symptoms (25%). Patients had normal skin at birth but soon developed extreme sensitivity to UVR in the form of exaggerated sun tanning, burning, and blistering on minimal sun exposure, followed by abnormal skin pigmentation like freckles and lentiginosis. Subsequently, over time there was progressive xerosis, atrophy, wrinkling, and poikiloderma. Six patients had varied degree of ocular involvement, while three of them had severe manifestation, including madarosis, tylosis, ectropion, Lagopthalmos, Pthysis bulbi, clouding and scarring of the cornea with complete or partial loss of vision, and ophthalmic malignancies. 50% (n=4) cases had skin and ocular pre-malignant (actinic keratosis) and malignant lesions, including melanoma and non melanoma skin cancer (NMSC) like squamous cell carcinoma (SCC) and basal cell carcinoma (BCC) in their early childhood. One patient had simultaneous occurrence of multiple malignancies together (SCC, BCC, and melanoma). Subnormal intelligence was noticed as neurological feature, and none had sensory neural hearing loss, microcephaly, neuroregression, or neurdeficit. All the patients had been being managed by a multidisciplinary team of pediatricians, dermatologists, ophthalmologists, neurologists and psychiatrists. Conclusion: Although till date there is no complete cure for XP and the disease is ultimately fatal. But increased awareness, early diagnosis followed by persistent vigorous protection from UVR, and regular screening for early detection of malignancies along with psychological support can drastically improve patients’ quality of life and life expectancy. Further research is required on formulating optimal management of XP, specifically the role and possibilities of gene therapy in XP.

Keywords: childhood malignancies, dermato-pathological findings, eastern India, Xeroderma pigmentosa

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114 One Year Follow up of Head and Neck Paragangliomas: A Single Center Experience

Authors: Cecilia Moreira, Rita Paiva, Daniela Macedo, Leonor Ribeiro, Isabel Fernandes, Luis Costa

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Background: Head and neck paragangliomas are a rare group of tumors with a large spectrum of clinical manifestations. The approach to evaluate and treat these lesions has evolved over the last years. Surgery was the standard for the approach of these patients, but nowadays new techniques of imaging and radiation therapy changed that paradigm. Despite advances in treating, the growth potential and clinical outcome of individual cases remain largely unpredictable. Objectives: Characterization of our institutional experience with clinical management of these tumors. Methods: This was a cross-sectional study of patients followed in our institution between 01 January and 31 December 2017 with paragangliomas of the head and neck and cranial base. Data on tumor location, catecholamine levels, and specific imaging modalities employed in diagnostic workup, treatment modality, tumor control and recurrence, complications of treatment and hereditary status were collected and summarized. Results: A total of four female patients were followed between 01 January and 31 December 2017 in our institution. The mean age of our cohort was 53 (± 16.1) years. The primary locations were at the level of the tympanic jug (n=2, 50%) and carotid body (n=2, 50%), and only one of the tumors of the carotid body presented pulmonary metastasis at the time of diagnosis. None of the lesions were catecholamine-secreting. Two patients underwent genetic testing, with no mutations identified. The initial clinical presentation was variable highlighting the decrease of visual acuity and headache as symptoms present in all patients. In one of the cases, loss of all teeth of the lower jaw was the presenting symptomatology. Observation with serial imaging, surgical extirpation, radiation, and stereotactic radiosurgery were employed as treatment approaches according to anatomical location and resectability of lesions. As post-therapeutic sequels the persistence of tinnitus and disabling pain stands out, presenting one of the patients neuralgia of the glossopharyngeal. Currently, all patients are under regular surveillance with a median follow up of 10 months. Conclusion: Ultimately, clinical management of these tumors remains challenging owing to heterogeneity in clinical presentation, the existence of multiple treatment alternatives, and potential to cause serious detriment to critical functions and consequently interference with the quality of life of the patients.

Keywords: clinical outcomes, head and neck, management, paragangliomas

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113 Kinematic Modelling and Task-Based Synthesis of a Passive Architecture for an Upper Limb Rehabilitation Exoskeleton

Authors: Sakshi Gupta, Anupam Agrawal, Ekta Singla

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An exoskeleton design for rehabilitation purpose encounters many challenges, including ergonomically acceptable wearing technology, architectural design human-motion compatibility, actuation type, human-robot interaction, etc. In this paper, a passive architecture for upper limb exoskeleton is proposed for assisting in rehabilitation tasks. Kinematic modelling is detailed for task-based kinematic synthesis of the wearable exoskeleton for self-feeding tasks. The exoskeleton architecture possesses expansion and torsional springs which are able to store and redistribute energy over the human arm joints. The elastic characteristics of the springs have been optimized to minimize the mechanical work of the human arm joints. The concept of hybrid combination of a 4-bar parallelogram linkage and a serial linkage were chosen, where the 4-bar parallelogram linkage with expansion spring acts as a rigid structure which is used to provide the rotational degree-of-freedom (DOF) required for lowering and raising of the arm. The single linkage with torsional spring allows for the rotational DOF required for elbow movement. The focus of the paper is kinematic modelling, analysis and task-based synthesis framework for the proposed architecture, keeping in considerations the essential tasks of self-feeding and self-exercising during rehabilitation of partially healthy person. Rehabilitation of primary functional movements (activities of daily life, i.e., ADL) is routine activities that people tend to every day such as cleaning, dressing, feeding. We are focusing on the feeding process to make people independent in respect of the feeding tasks. The tasks are focused to post-surgery patients under rehabilitation with less than 40% weakness. The challenges addressed in work are ensuring to emulate the natural movement of the human arm. Human motion data is extracted through motion-sensors for targeted tasks of feeding and specific exercises. Task-based synthesis procedure framework will be discussed for the proposed architecture. The results include the simulation of the architectural concept for tracking the human-arm movements while displaying the kinematic and static study parameters for standard human weight. D-H parameters are used for kinematic modelling of the hybrid-mechanism, and the model is used while performing task-based optimal synthesis utilizing evolutionary algorithm.

Keywords: passive mechanism, task-based synthesis, emulating human-motion, exoskeleton

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112 Basal Cell Carcinoma Excision Intraoperative Frozen Section for Tumor Clearance and Reconstructive Surgery: A Prospective Open Label Interventional Study

Authors: Moizza Tahir, Uzma Bashir, Aisha Akhtar, Zainab Ansari, Sameen Ansari, Muhammad Ali Tahir

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Cancer burden has globally increased. Among cutaneous cancers basal cell carcinoma constitute vast majority of skin cancer. There is need for appropriate diagnostic, therapeutic and prognostic significance evaluation for skin cancers Present study report intraoperative frozen section (FS) histopathological clearance for excision of BCC in a tertiary care center and find the frequency of involvement of surgical margin with reference to anatomical site, with size and surgical technique. It was prospective open label interventional study conducted at Dermatology department of tertiary care hospital Rawalpindi Pakistan in lais on with histopathology department from January 2023 to April 2024. Total of thirty-six (n = 36) patients between age 45-80 years with basal cell carcinoma of 10-20mm on face were included following inclusion exclusion criteria by purposive sampling technique. Informed consent was taken. Surgical excision was performed and intraoperative frozen section histopathology clearance of tumor margin was taken from histopathologist on telephone. Surgical reconstruction was done. Final Histopathology report was reexamined on day 10th for margin and depth clearance. Descriptive statistics were calculated for age, gender, sun exposure, reconstructive technique, anatomical site, and tumor free margin report on frozen section analysis. Chi square test was employed for statistical significance of involvement of surgical margin with reference to anatomical site, size and decision on reconstructive surgical technique, p value of <0.05 was considered significant. Total of 36 patients of BCC were enrolled, males 12 (33.3%) and females were 24 (66.6%). Age ranged from 45 year to 80 year mean of 58.36 ±SD7.8. Size of BCC ranged from 10mm to 35mm mean of 25mm ±SD 0.63. Morphology was nodular 18 (50%), superficial spreading 11(30.6%), morphoeic 1 (2.8%) and ulcerative in 6(16.7%) cases. Intraoperative frozen section for histopathological margin clearance with 2-3 mm safety margin and surgical technique has p-value0.51, for anatomical site p value 0.24 and size p-0.84. Intraoperative frozen section (FS) histopathological clearance for BCC face with 2-3mm safety margin with reference to reconstructive technique, anatomical site and size of BCC were insignificant.

Keywords: basal cell carcinoma, tumor free amrgin, basal cell carcinoma and frozen section, safety margin

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111 A Seven Year Single-Centre Study of Dental Implant Survival in Head and Neck Oncology Patients

Authors: Sidra Suleman, Maliha Suleman, Stephen Brindley

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Oral rehabilitation of head and neck cancer patients plays a crucial role in the quality of life for such individuals post-treatment. Placement of dental implants or implant-retained prostheses can help restore oral function and aesthetics, which is often compromised following surgery. Conventional prosthodontic techniques can be insufficient in rehabilitating such patients due to their altered anatomy and reduced oral competence. Hence, there is a strong clinical need for the placement of dental implants. With an increasing incidence of head and neck cancer patients, the demand for such treatment is rising. Aim: The aim of the study was to determine the survival rate of dental implants in head and neck cancer patients placed at the Restorative and Maxillofacial Department, Royal Stoke University Hospital (RSUH), United Kingdom. Methodology: All patients who received dental implants between January 1, 2013 to December 31, 2020 were identified. Patients were excluded based on three criteria: 1) non-head and neck cancer patients, 2) no outpatient follow-up post-implant placement 3) provision of non-dental implants. Scanned paper notes and electronic records were extracted and analyzed. Implant survival was defined as fixtures that had remained in-situ / not required removal. Sample: Overall, 61 individuals were recruited from the 143 patients identified. The mean age was 64.9 years, with a range of 35 – 89 years. The sample included 37 (60.7%) males and 24 (39.3%) females. In total, 211 implants were placed, of which 40 (19.0%) were in the maxilla, 152 (72.0%) in the mandible and 19 (9.0%) in autogenous bone graft sites. Histologically 57 (93.4%) patients had squamous cell carcinoma, with 43 (70.5%) patients having either stage IVA or IVB disease. As part of treatment, 42 (68.9%) patients received radiotherapy, which was carried out post-operatively for 29 (69.0%) cases. Whereas 21 (34.4%) patients underwent chemotherapy, 13 (61.9%) of which were post-operative. The Median follow-up period was 21.9 months with a range from 0.9 – 91.4 months. During the study, 23 (37.7%) patients died and their data was censored beyond the date of death. Results: In total, four patients who had received radiotherapy had one implant failure each. Two mandibular implants failed secondary to osteoradionecrosis, and two maxillary implants did not survive as a result of failure to osseointegrate. The overall implant survival rates were 99.1% at three years and 98.1% at both 5 and 7 years. Conclusions: Although this data shows that implant failure rates are low, it highlights the difficulty in predicting which patients will be affected. Future studies involving larger cohorts are warranted to further analyze factors affecting outcomes.

Keywords: oncology, dental implants, survival, restorative

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110 Lactobacillus rhamnosus GG Increases the Re-Epithelialization Rate of Model Wounds by Stimulating Keratinocyte Migration in Ex-Vivo

Authors: W. Mohammedsaeed, A. J. Mcbain, S. M. Cruickshank, C. A. O’Neill

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Many studies have demonstrated the importance of probiotics and their potential therapeutic effects within the gut. Recently, the possible therapeutic effects of probiotics in other tissues have also begun to be investigated. Comparatively few studies have evaluated the use of topical probiotics in relation to the skin. In this study, we have conducted preliminary investigations into whether a well-known probiotic, Lactobacillus rhamnosus GG (LGG), can increase the rate of re-epithelialization in a model wound. Full-thickness skin was obtained from individuals undergoing elective cosmetic surgery. This skin was wounded using excisional punch and cultured using a serum-free medium, either in the presence or absence of L. rhamnosus GG lysate. Histological staining of the sections was performed with Haematoxylin& Eosin E to quantify “epithelial tongue length”. This is the length of the new epithelial ‘tongue’ that grows and covers the exposed dermis at the inner wound edges. The length of the new epithelial ‘tongue’ was compared in untreated section and section treated with and L. rhamnosus GG made using108CFU/ml bacterial cells. L. rhamnosus GG lysate enhanced significantly the re-epithelialisation of treated wounds compared with that of untreated wounds (P=0.005, n=3). Tongue length, at day 1 was 7.55μm 0.15, at day 3 it was 18.5μm 0.25 and at day 7 was 22.9μm 0.35. These results can be compared with untreated cultures in which tongue length was 3.25μm 0.35, day 3 was 9.65μm 0.25 and day 7 was 13.5μm 0.15 post-wounding. In ex-vivo proliferation and migration cells were measured by determining the expression of nuclear proliferation marker Ki-67 and the expression of Phosphorylated cortactin respectively demonstrated that L. rhamnosus GG significantly increased NHEK proliferation and migration rates relative to controls. However, the dominant mechanism was migration because in ex-vivo skin treated with the L. rhamnosus GG up-regulated the gene expression of the chemokine receptor and ligands CXCR2 and CXCL2 comparing with controls (P=0.02, P=0.03 respectively, n=3). High levels of CXCL2/CXCL2 have already been implicated in multiple aspects of stimulation of wound healing through activation of keratinocyte migration. These data demonstrate that lysates from Lactobacillus rhamnosus GG increase re-epithelialization by stimulation of keratinocyte migration. The current study identifies the partial mechanism that contribute to stimulating the wound-healing process ex vivo in response to L. rhamnosus GG lysate is an increase in the production of CXCL2/ CXCR2 in ex vivo models. The use of probiotic lysates potentially offers new options to develop treatments that could improve wound healing.

Keywords: Lactobacillus rhamnosus GG, wounds, migration, lysate

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109 Preliminary Results on a Study of Antimicrobial Susceptibility Testing of Bacillus anthracis Strains Isolated during Anthrax Outbreaks in Italy from 2001 to 2017

Authors: Viviana Manzulli, Luigina Serrecchia, Adelia Donatiello, Valeria Rondinone, Sabine Zange, Alina Tscherne, Antonio Parisi, Antonio Fasanella

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Anthrax is a zoonotic disease that affects a wide range of animal species (primarily ruminant herbivores), and can be transmitted to humans through consumption or handling of contaminated animal products. The etiological agent B.anthracis is able to survive in unfavorable environmental conditions by forming endospore which remain viable in the soil for many decades. Furthermore, B.anthracis is considered as one of the most feared agents to be potentially misused as a biological weapon and the importance of the disease and its treatment in humans has been underscored before the bioterrorism events in the United States in 2001. Due to the often fatal outcome of human cases, antimicrobial susceptibility testing plays especially in the management of anthrax infections an important role. In Italy, animal anthrax is endemic (predominantly found in the southern regions and on islands) and is characterized by sporadic outbreaks occurring mainly during summer. Between 2012 and 2017 single human cases of cutaneous anthrax occurred. In this study, 90 diverse strains of B.anthracis, isolated in Italy from 2001 to 2017, were screened to their susceptibility to sixteen clinically relevant antimicrobial agents by using the broth microdilution method. B.anthracis strains selected for this study belong to the strain collection stored at the Anthrax Reference Institute of Italy located inside the Istituto Zooprofilattico Sperimentale of Puglia and Basilicata. The strains were isolated at different time points and places from various matrices (human, animal and environmental). All strains are a representative of over fifty distinct MLVA 31 genotypes. The following antibiotics were used for testing: gentamicin, ceftriaxone, streptomycin, penicillin G, clindamycin, chloramphenicol, vancomycin, linezolid, cefotaxime, tetracycline, erythromycin, rifampin, amoxicillin, ciprofloxacin, doxycycline and trimethoprim. A standard concentration of each antibiotic was prepared in a specific diluent, which were then twofold serial diluted. Therefore, each wells contained: bacterial suspension of 1–5x104 CFU/mL in Mueller-Hinton Broth (MHB), the antibiotic to be tested at known concentration and resazurin, an indicator of cell growth. After incubation overnight at 37°C, the wells were screened for color changes caused by the resazurin: a change from purple to pink/colorless indicated cell growth. The lowest concentration of antibiotic that prevented growth represented the minimal inhibitory concentration (MIC). This study suggests that B.anthracis remains susceptible in vitro to many antibiotics, in addition to doxycycline (MICs ≤ 0,03 µg/ml), ciprofloxacin (MICs ≤ 0,03 µg/ml) and penicillin G (MICs ≤ 0,06 µg/ml), recommend by CDC for the treatment of human cases and for prophylactic use after exposure to the spores. In fact, the good activity of gentamicin (MICs ≤ 0,25 µg/ml), streptomycin (MICs ≤ 1 µg/ml), clindamycin (MICs ≤ 0,125 µg/ml), chloramphenicol(MICs ≤ 4 µg/ml), vancomycin (MICs ≤ 2 µg/ml), linezolid (MICs ≤ 2 µg/ml), tetracycline (MICs ≤ 0,125 µg/ml), erythromycin (MICs ≤ 0,25 µg/ml), rifampin (MICs ≤ 0,25 µg/ml), amoxicillin (MICs ≤ 0,06 µg/ml), towards all tested B.anthracis strains demonstrates an appropriate alternative choice for prophylaxis and/or treatment. All tested B.anthracis strains showed intermediate susceptibility to the cephalosporins (MICs ≥ 16 µg/ml) and resistance to trimethoprim (MICs ≥ 128 µg/ml).

Keywords: Bacillus anthracis, antibiotic susceptibility, treatment, minimum inhibitory concentration

Procedia PDF Downloads 198
108 The Role of Glyceryl Trinitrate (GTN) in 99mTc-HIDA with Morphine Provocation Scan for the Investigation of Type III Sphincter of Oddi Dysfunction (SOD)

Authors: Ibrahim M Hassan, Lorna Que, Michael Rutland

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Type I SOD is usually diagnosed by anatomical imaging such as ultrasound, CT and MRCP. However, the types II and III SOD yield negative results despite the presence of significant symptoms. In particular, the type III is difficult to diagnose due to the absence of significant biochemical or anatomical abnormalities. Nuclear Medicine can aid in this diagnostic dilemma by demonstrating functional changes in the bile flow. Low dose Morphine (0.04mg/Kg) stimulates the tone of the sphincter of Oddi (SO) and its usefulness has been shown in diagnosing SOD by causing a delay in bile flow when compared to a non morphine provoked - baseline scan. This work expands on that process by using sublingual GTN at 60 minutes post tracer and morphine injection to relax the SO and induce an improvement in bile outflow, and in some cases show immediate relief of morphine induced abdominal pain. The criteria for positive SOD are as follows: if during the first hour of the morphine provocation showed (1) delayed intrahepatic biliary ducts tracer accumulation; plus (2) delayed appearance but persistent retention of activity in the common bile duct, and (3) delayed bile flow into the duodenum. In addition, patients who required GTN within the first hour to relieve abdominal pain were regarded as highly supportive of the diagnosis. Retrospective analysis of 85 patients (pts) (78F and 6M) referred for suspected SOD (type III) who had been intensively investigated because of recurrent right upper quadrant or abdominal pain post cholecystectomy. 99mTc-HIDA scan with morphine-provocation is performed followed by GTN at 60 minutes post tracer injection and a further thirty minutes of dynamic imaging are acquired. 30 pts were negative. 55 pts were regarded as positive for SOD and 38/55 (60%) of these patients with an abnormal result were further evaluated with a baseline 99mTc-HIDA. As expected, all 38 pts showed better bile flow characteristics than during the morphine provocation. 20/55 (36%) patients were treated by ERCP sphincterotomy and the rest were managed conservatively by medical therapy. In all cases regarded as positive for SOD, the sublingual GTN at 60 minutes showed immediate improvement in bile flow. 11/55(20%) who developed severe post-morphine abdominal pain were relieved by GTN almost instantaneously. We propose that GTN is a useful agent in the diagnosis of SOD when performing 99mTc-HIDA scan and that the satisfactory response to the sublingual GTN could offer additional information in patients who have severe pain at the time the procedure or when presenting to the emergency unit because of biliary pain. And also in determining whether a trial of medical therapy may be used before considering surgery.

Keywords: GTN, HIDA, MORPHINE, SOD

Procedia PDF Downloads 288
107 A Systemic Review and Comparison of Non-Isolated Bi-Directional Converters

Authors: Rahil Bahrami, Kaveh Ashenayi

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This paper presents a systematic classification and comparative analysis of non-isolated bi-directional DC-DC converters. The increasing demand for efficient energy conversion in diverse applications has spurred the development of various converter topologies. In this study, we categorize bi-directional converters into three distinct classes: Inverting, Non-Inverting, and Interleaved. Each category is characterized by its unique operational characteristics and benefits. Furthermore, a practical comparison is conducted by evaluating the results of simulation of each bi-directional converter. BDCs can be classified into isolated and non-isolated topologies. Non-isolated converters share a common ground between input and output, making them suitable for applications with minimal voltage change. They are easy to integrate, lightweight, and cost-effective but have limitations like limited voltage gain, switching losses, and no protection against high voltages. Isolated converters use transformers to separate input and output, offering safety benefits, high voltage gain, and noise reduction. They are larger and more costly but are essential for automotive designs where safety is crucial. The paper focuses on non-isolated systems.The paper discusses the classification of non-isolated bidirectional converters based on several criteria. Common factors used for classification include topology, voltage conversion, control strategy, power capacity, voltage range, and application. These factors serve as a foundation for categorizing converters, although the specific scheme might vary depending on contextual, application, or system-specific requirements. The paper presents a three-category classification for non-isolated bi-directional DC-DC converters: inverting, non-inverting, and interleaved. In the inverting category, converters produce an output voltage with reversed polarity compared to the input voltage, achieved through specific circuit configurations and control strategies. This is valuable in applications such as motor control and grid-tied solar systems. The non-inverting category consists of converters maintaining the same voltage polarity, useful in scenarios like battery equalization. Lastly, the interleaved category employs parallel converter stages to enhance power delivery and reduce current ripple. This classification framework enhances comprehension and analysis of non-isolated bi-directional DC-DC converters. The findings contribute to a deeper understanding of the trade-offs and merits associated with different converter types. As a result, this work aids researchers, practitioners, and engineers in selecting appropriate bi-directional converter solutions for specific energy conversion requirements. The proposed classification framework and experimental assessment collectively enhance the comprehension of non-isolated bi-directional DC-DC converters, fostering advancements in efficient power management and utilization.The simulation process involves the utilization of PSIM to model and simulate non-isolated bi-directional converter from both inverted and non-inverted category. The aim is to conduct a comprehensive comparative analysis of these converters, considering key performance indicators such as rise time, efficiency, ripple factor, and maximum error. This systematic evaluation provides valuable insights into the dynamic response, energy efficiency, output stability, and overall precision of the converters. The results of this comparison facilitate informed decision-making and potential optimizations, ensuring that the chosen converter configuration aligns effectively with the designated operational criteria and performance goals.

Keywords: bi-directional, DC-DC converter, non-isolated, energy conversion

Procedia PDF Downloads 80
106 Implementing a Structured, yet Flexible Tool for Critical Information Handover

Authors: Racheli Magnezi, Inbal Gazit, Michal Rassin, Joseph Barr, Orna Tal

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An effective process for transmitting patient critical information is essential for patient safety and for improving communication among healthcare staff. Previous studies have discussed handover tools such as SBAR (Situation, Background, Assessment, Recommendation) or SOFI (Short Observational Framework for Inspection). Yet, these formats lack flexibility, and require special training. In addition, nurses and physicians have different procedures for handing over information. The objectives of this study were to establish a universal, structured tool for handover, for both physicians and nurses, based on parameters that were defined as ‘important’ and ‘appropriate’ by the medical team, and to implement this tool in various hospital departments, with flexibility for each ward. A questionnaire, based on established procedures and on the literature, was developed to assess attitudes towards the most important information for effective handover between shifts (Cronbach's alpha 0.78). It was distributed to 150 senior physicians and nurses in 62 departments. Among senior medical staff, 12 physicians and 66 nurses responded to the questionnaire (52% response rate). Based on the responses, a handover form suitable for all hospital departments was designed and implemented. Important information for all staff included: Patient demographics (full name and age); Health information (diagnosis or patient complaint, changes in hemodynamic status, new medical treatment or equipment required); and Social Information (suspicion of violence, mental or behavioral changes, and guardianship). Additional information relevant to each unit included treatment provided, laboratory or imaging required, and change in scheduled surgery in surgical departments. ICU required information on background illnesses, Pediatrics required information on diet and food provided and Obstetrics required the number of days after cesarean section. Based on the model described, a flexible tool was developed that enables handover of both common and unique information. In addition, it includes general logistic information that must be transmitted to the next shift, such as planned disruptions in service or operations, staff training, etc. Development of a simple, clear, comprehensive, universal, yet flexible tool designed for all medical staff for transmitting critical information between shifts was challenging. Physicians and nurses found it useful and it was widely implemented. Ongoing research is needed to examine the efficiency of this tool, and whether the enthusiasm that accompanied its initial use is maintained.

Keywords: handover, nurses, hospital, critical information

Procedia PDF Downloads 234
105 Development of a Mixed-Reality Hands-Free Teleoperated Robotic Arm for Construction Applications

Authors: Damith Tennakoon, Mojgan Jadidi, Seyedreza Razavialavi

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With recent advancements of automation in robotics, from self-driving cars to autonomous 4-legged quadrupeds, one industry that has been stagnant is the construction industry. The methodologies used in a modern-day construction site consist of arduous physical labor and the use of heavy machinery, which has not changed over the past few decades. The dangers of a modern-day construction site affect the health and safety of the workers due to performing tasks such as lifting and moving heavy objects and having to maintain unhealthy posture to complete repetitive tasks such as painting, installing drywall, and laying bricks. Further, training for heavy machinery is costly and requires a lot of time due to their complex control inputs. The main focus of this research is using immersive wearable technology and robotic arms to perform the complex and intricate skills of modern-day construction workers while alleviating the physical labor requirements to perform their day-to-day tasks. The methodology consists of mounting a stereo vision camera, the ZED Mini by Stereolabs, onto the end effector of an industrial grade robotic arm, streaming the video feed into the Virtual Reality (VR) Meta Quest 2 (Quest 2) head-mounted display (HMD). Due to the nature of stereo vision, and the similar field-of-views between the stereo camera and the Quest 2, human-vision can be replicated on the HMD. The main advantage this type of camera provides over a traditional monocular camera is it gives the user wearing the HMD a sense of the depth of the camera scene, specifically, a first-person view of the robotic arm’s end effector. Utilizing the built-in cameras of the Quest 2 HMD, open-source hand-tracking libraries from OpenXR can be implemented to track the user’s hands in real-time. A mixed-reality (XR) Unity application can be developed to localize the operator's physical hand motions with the end-effector of the robotic arm. Implementing gesture controls will enable the user to move the robotic arm and control its end-effector by moving the operator’s arm and providing gesture inputs from a distant location. Given that the end effector of the robotic arm is a gripper tool, gripping and opening the operator’s hand will translate to the gripper of the robot arm grabbing or releasing an object. This human-robot interaction approach provides many benefits within the construction industry. First, the operator’s safety will be increased substantially as they can be away from the site-location while still being able perform complex tasks such as moving heavy objects from place to place or performing repetitive tasks such as painting walls and laying bricks. The immersive interface enables precision robotic arm control and requires minimal training and knowledge of robotic arm manipulation, which lowers the cost for operator training. This human-robot interface can be extended to many applications, such as handling nuclear accident/waste cleanup, underwater repairs, deep space missions, and manufacturing and fabrication within factories. Further, the robotic arm can be mounted onto existing mobile robots to provide access to hazardous environments, including power plants, burning buildings, and high-altitude repair sites.

Keywords: construction automation, human-robot interaction, hand-tracking, mixed reality

Procedia PDF Downloads 66
104 Establishment of a Classifier Model for Early Prediction of Acute Delirium in Adult Intensive Care Unit Using Machine Learning

Authors: Pei Yi Lin

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Objective: The objective of this study is to use machine learning methods to build an early prediction classifier model for acute delirium to improve the quality of medical care for intensive care patients. Background: Delirium is a common acute and sudden disturbance of consciousness in critically ill patients. After the occurrence, it is easy to prolong the length of hospital stay and increase medical costs and mortality. In 2021, the incidence of delirium in the intensive care unit of internal medicine was as high as 59.78%, which indirectly prolonged the average length of hospital stay by 8.28 days, and the mortality rate is about 2.22% in the past three years. Therefore, it is expected to build a delirium prediction classifier through big data analysis and machine learning methods to detect delirium early. Method: This study is a retrospective study, using the artificial intelligence big data database to extract the characteristic factors related to delirium in intensive care unit patients and let the machine learn. The study included patients aged over 20 years old who were admitted to the intensive care unit between May 1, 2022, and December 31, 2022, excluding GCS assessment <4 points, admission to ICU for less than 24 hours, and CAM-ICU evaluation. The CAMICU delirium assessment results every 8 hours within 30 days of hospitalization are regarded as an event, and the cumulative data from ICU admission to the prediction time point are extracted to predict the possibility of delirium occurring in the next 8 hours, and collect a total of 63,754 research case data, extract 12 feature selections to train the model, including age, sex, average ICU stay hours, visual and auditory abnormalities, RASS assessment score, APACHE-II Score score, number of invasive catheters indwelling, restraint and sedative and hypnotic drugs. Through feature data cleaning, processing and KNN interpolation method supplementation, a total of 54595 research case events were extracted to provide machine learning model analysis, using the research events from May 01 to November 30, 2022, as the model training data, 80% of which is the training set for model training, and 20% for the internal verification of the verification set, and then from December 01 to December 2022 The CU research event on the 31st is an external verification set data, and finally the model inference and performance evaluation are performed, and then the model has trained again by adjusting the model parameters. Results: In this study, XG Boost, Random Forest, Logistic Regression, and Decision Tree were used to analyze and compare four machine learning models. The average accuracy rate of internal verification was highest in Random Forest (AUC=0.86), and the average accuracy rate of external verification was in Random Forest and XG Boost was the highest, AUC was 0.86, and the average accuracy of cross-validation was the highest in Random Forest (ACC=0.77). Conclusion: Clinically, medical staff usually conduct CAM-ICU assessments at the bedside of critically ill patients in clinical practice, but there is a lack of machine learning classification methods to assist ICU patients in real-time assessment, resulting in the inability to provide more objective and continuous monitoring data to assist Clinical staff can more accurately identify and predict the occurrence of delirium in patients. It is hoped that the development and construction of predictive models through machine learning can predict delirium early and immediately, make clinical decisions at the best time, and cooperate with PADIS delirium care measures to provide individualized non-drug interventional care measures to maintain patient safety, and then Improve the quality of care.

Keywords: critically ill patients, machine learning methods, delirium prediction, classifier model

Procedia PDF Downloads 51
103 An Interesting Case of Management of Life Threatening Calcium Disequilibrium in a Patient with Parathyroid Tumor

Authors: Rajish Shil, Mohammad Ali Houri, Mohammad Milad Ismail, Fatimah Al Kaabi

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The clinical presentation of Primary hyperparathyroidism can vary from simple asymptomatic hypercalcemia to severe life-threatening hypercalcemic crisis with multi-organ dysfunction, which can be due to parathyroid adenoma or sometimes with malignant cancer. This cascade of clinical presentation can lead to a diagnostic and therapeutic challenge for treating the disease. We are presenting a case of severe hypercalcemic crisis due to parathyroid adenoma with an emphasis on early management, diagnosis, and interventions to prevent any lifelong complications and any permanent organ dysfunction. A 30 years old female with a history of primary Infertility, admitted to Al Ain Hospital critical care unit with Acute Severe Necrotizing Pancreatitis. She initially had a 1-month history of abdominal pain on and off, for which she was treated conservatively with no much improvement, and later on, she developed life-threatening severe pancreatitis, which required her to be admitted to the critical care unit. She was transferred from a private healthcare facility, where she was found to have a very high level of calcium up to 15mmol/L. She received systemic Zoledronic Acid, which lowered her calcium level transiently and later was increased again. She went on to develop multiple end-organ damages along with multiple electrolytes disturbances. She was found to have high levels of Parathyroid hormone, which was correlated with a parathyroid mass on the neck via radiological imaging. After a long course of medical treatment to lower the calcium to a near-normal level, parathyroidectomy was done, which showed parathyroid adenoma on histology. She developed hungry bone syndrome after the surgery and pancreatic pseudocyst after resolving of pancreatitis. She required aggressive treatment with Intravenous calcium for her hypocalcemia as she received zoledronic acid at the beginning of the disease. Later on, she was discharged on long term calcium and other electrolytes supplements. In patients presenting with hypercalcemia, it is prudent to investigate and start treatment early to prevent complications and end-organ damage from hypercalcemia and also to treat the primary cause of the hypercalcemia, with conscious follow up to prevent hypocalcemic complications after treatment. It is important to follow up patients with parathyroid adenomas for a long period in order to detect any recurrence of the tumor or to make sure if the primary tumor is either benign or malignant.

Keywords: hypercalcemia, pancreatitis, hypocalcemia, hyperparathyroidism

Procedia PDF Downloads 105
102 Framework to Organize Community-Led Project-Based Learning at a Massive Scale of 900 Indian Villages

Authors: Ayesha Selwyn, Annapoorni Chandrashekar, Kumar Ashwarya, Nishant Baghel

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Project-based learning (PBL) activities are typically implemented in technology-enabled schools by highly trained teachers. In rural India, students have limited access to technology and quality education. Implementing typical PBL activities is challenging. This study details how Pratham Education Foundation’s Hybrid Learning model was used to implement two PBL activities related to music in 900 remote Indian villages with 46,000 students aged 10-14. The activities were completed by 69% of groups that submitted a total of 15,000 videos (completed projects). Pratham’s H-Learning model reaches 100,000 students aged 3-14 in 900 Indian villages. The community-driven model engages students in 20,000 self-organized groups outside of school. The students are guided by 6,000 youth volunteers and 100 facilitators. The students partake in learning activities across subjects with the support of community stakeholders and offline digital content on shared Android tablets. A training and implementation toolkit for PBL activities is designed by subject experts. This toolkit is essential in ensuring efficient implementation of activities as facilitators aren’t highly skilled and have limited access to training resources. The toolkit details the activity at three levels of student engagement - enrollment, participation, and completion. The subject experts train project leaders and facilitators who train youth volunteers. Volunteers need to be trained on how to execute the activity and guide students. The training is focused on building the volunteers’ capacity to enable students to solve problems, rather than developing the volunteers’ subject-related knowledge. This structure ensures that continuous intervention of subject matter experts isn’t required, and the onus of judging creativity skills is put on community members. 46,000 students in the H-Learning program were engaged in two PBL activities related to Music from April-June 2019. For one activity, students had to conduct a “musical survey” in their village by designing a survey and shooting and editing a video. This activity aimed to develop students’ information retrieval, data gathering, teamwork, communication, project management, and creativity skills. It also aimed to identify talent and document local folk music. The second activity, “Pratham Idol”, was a singing competition. Students participated in performing, producing, and editing videos. This activity aimed to develop students’ teamwork and creative skills and give students a creative outlet. Students showcased their completed projects at village fairs wherein a panel of community members evaluated the videos. The shortlisted videos from all villages were further evaluated by experts who identified students and adults to participate in advanced music workshops. The H-Learning framework enables students in low resource settings to engage in PBL and develop relevant skills by leveraging community support and using video creation as a tool. In rural India, students do not have access to high-quality education or infrastructure. Therefore designing activities that can be implemented by community members after limited training is essential. The subject experts have minimal intervention once the activity is initiated, which significantly reduces the cost of implementation and allows the activity to be implemented at a massive scale.

Keywords: community supported learning, project-based learning, self-organized learning, education technology

Procedia PDF Downloads 167
101 The Role of Rapid Maxillary Expansion in Managing Obstructive Sleep Apnea in Children: A Literature Review

Authors: Suleman Maliha, Suleman Sidra

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Obstructive sleep apnea (OSA) is a sleep disorder that can result in behavioral and psychomotor impairments in children. The classical treatment modalities for OSA have been continuous positive airway pressure and adenotonsillectomy. However, orthodontic intervention through rapid maxillary expansion (RME) has also been commonly used to manage skeletal transverse maxillary discrepancies. Aim and objectives: The aim of this study is to determine the efficacy of rapid maxillary expansion in paediatric patients with obstructive sleep apnea by assessing pre and post-treatment mean apnea-hypopnea index (AHI) and oxygen saturations. Methodology: Literature was identified through a rigorous search of the Embase, Pubmed, and CINAHL databases. Articles published from 2012 onwards were selected. The inclusion criteria consisted of patients aged 18 years and under with no systemic disease, adenotonsillar surgery, or hypertrophy who are undergoing RME with AHI measurements before and after treatment. In total, six suitable papers were identified. Results: Three studies assessed patients pre and post-RME at 12 months. The first study consisted of 15 patients with an average age of 7.5 years. Following treatment, they found that RME resulted in both higher oxygen saturations (+ 5.3%) and improved AHI (- 4.2 events). The second study assessed 11 patients aged 5–8 years and also noted improvements, with mean AHI reduction from 6.1 to 2.4 and oxygen saturations increasing from 93.1% to 96.8%. The third study reviewed 14 patients aged 6–9 years and similarly found an AHI reduction from 5.7 to 4.4 and an oxygen saturation increase from 89.8% to 95.5%. All modifications noted in these studies were statistically significant. A long-term study reviewed 23 patients aged 6–12 years post-RME treatment on an annual basis for 12 years. They found that the mean AHI reduced from 12.2 to 0.4, with improved oxygen saturations from 78.9% to 95.1%. Another study assessed 19 patients aged 9-12 years at two months into RME and four months post-treatment. Improvements were also noted at both stages, with an overall reduction of the mean AHI from 16.3 to 0.8 and an overall increase in oxygen saturations from 77.9% to 95.4%. The final study assessed 26 children aged 7-11 years on completion of individual treatment and found an AHI reduction from 6.9 to 5.3. However, the oxygen saturation remained stagnant at 96.0%, but this was not clinically significant. Conclusion: Overall, the current evidence suggests that RME is a promising treatment option for paediatric patients with OSA. It can provide efficient and conservative treatment; however, early diagnosis is crucial. As there are various factors that could be contributing to OSA, it is important that each case is treated on its individual merits. Going forward, there is a need for more randomized control trials with larger cohorts being studied. Research into the long-term effects of RME and potential relapse amongst cases would also be useful.

Keywords: orthodontics, sleep apnea, maxillary expansion, review

Procedia PDF Downloads 63
100 Thyroid Cancer Treatment in Yemen Under Blockade Conditions and Absence of Radioactive Iodine

Authors: Anis Al-Yakhiri

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Introduction: The World Health Organization (WHO) classifies malignant epithelial thyroid tumors into four major groups (papillary, follicular, medullar and undifferentiated) . Papillary thyroid carcinoma (PTC) is the most common type, for about eight out of ten thyroid cancers belong to this histological type. Radioactive iodine (RAI) is considered effective for patients with total or nearly total thyroidectomy, but the beneficial effects of RAI are still controversial. War conditions forced us to study alternative methods of using radioactive iodine in the treatment of patients with PTC. Material and methods: Between January 2014 and June 2021, in Al-Yakhiri hospital, 57 Total Thyroidectomy with Radical BilateralNeckDissection (RBND) were performed, 50 for malignant disease,7 for false positive cytology.RBND involves surgical clearance of Levels II-VI. Mean age was 40.7 years old and 92% of the patients were female. 7(14%) patients had hypothyroidism which required preoperative thyroid hormone treatment. The Thyroid Stimulating Hormone- Suppression Therapy (TSH-ST) immediately started after RBND for mostpatients on the first day. It consisted in reducing the level of TSH< 0.1 mIU/L. Results: The Apron flap was used on most operations (40)80% and with lateral extensions had 10(20%). RBND involves surgical clearance of Levels II-VI performed in all operated patients, besides that, 4(8%) of them had resection of sternocleidomastoid muscle (SCM) and accessory nerve (XIn) and internal jugular vein (IJV) withclearance of Levels IB. The PTC was the most common 80.9% (38 patients from 47)by histopathological report. and 4(8%) patients of 50 had resection of sternocleidomastoid muscle (SCM) and accessory nerve (XIn) and internal jugular vein (IJV). The postoperative mortality rate not observed (0%). The postoperative morbidity rate was 22.8% (n =13).Seroma(8.7%),Hypocalcimia(7%), Wound infection(5.3%), Bleeding(1.8%). To suppress TSH and growth of any residual thyroid theTSH-ST (levothyroxine150 – 600mcg)was performed in all patients 57(100%) on the first day afterRBND. We tracked the results of treatment for two years in 30 patients with PTC, only 3 of them received radioactive iodine abroad. Biennial Recurrence rate for PTC appeared in one woman (2%), who had RAI postoperatively in the form of neck lymph nodes metastasis. Conclusion: For patients with PTC, thyroidectomy plus prophylacticRBND is a safe and efficient procedure and it results in lower recurrence rate. Postoperative treatment with exogenous thyroid hormone in doses sufficient to suppress TSH (not less than 150mcg), decreases incidence of recurrence. Total Thyroidectomy with RBND followed by TSH-ST, in our opinion, applicable optimal treatment scheme care for this patient population.

Keywords: thyroid cancer, Yemen war, absence of radioactive iodine, neck dissection, surgery results

Procedia PDF Downloads 59
99 Experiences of Discrimination and Coping Strategies of Second Generation Academics during the Career-Entry Phase in Austria

Authors: R. Verwiebe, L. Seewann, M. Wolf

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This presentation addresses marginalization and discrimination as experienced by young academics with a migrant background in the Austrian labor market. Focusing on second generation academics of Central Eastern European and Turkish descent we explore two major issues. First, we ask whether their career-entry and everyday professional life entails origin-specific barriers. As educational residents, they show competences which, when lacking, tend to be drawn upon to explain discrimination: excellent linguistic skills, accredited high-level training, and networks. Second, we concentrate on how this group reacts to discrimination and overcomes experiences of marginalization. To answer these questions, we utilize recent sociological and social psychological theories that focus on the diversity of individual experiences. This distinguishes us from a long tradition of research that has dealt with the motives that inform discrimination, but has less often considered the effects on those concerned. Similarly, applied coping strategies have less often been investigated, though they may provide unique insights into current problematic issues. Building upon present literature, we follow recent discrimination research incorporating the concepts of ‘multiple discrimination’, ‘subtle discrimination’, and ‘visual social markers’. 21 problem-centered interviews are the empirical foundation underlying this study. The interviewees completed their entire educational career in Austria, graduated in different universities and disciplines and are working in their first post-graduate jobs (career entry phase). In our analysis, we combined thematic charting with a coding method. The results emanating from our empirical material indicated a variety of discrimination experiences ranging from barely perceptible disadvantages to directly articulated and overt marginalization. The spectrum of experiences covered stereotypical suppositions at job interviews, the disavowal of competencies, symbolic or social exclusion by new colleges, restricted professional participation (e.g. customer contact) and non-recruitment due to religious or ethnical markers (e.g. headscarves). In these experiences the role of the academics education level, networks, or competences seemed to be minimal, as negative prejudice on the basis of visible ‘social markers’ operated ‘ex-ante’. The coping strategies identified in overcoming such barriers are: an increased emphasis on effort, avoidance of potentially marginalizing situations, direct resistance (mostly in the form of verbal opposition) and dismissal of negative experiences by ignoring or ironizing the situation. In some cases, the academics drew into their specific competences, such as an intellectual approach of studying specialist literature, focus on their intercultural competences or planning to migrate back to their parent’s country of origin. Our analysis further suggests a distinction between reactive (i.e. to act on and respond to experienced discrimination) and preventative strategies (applied to obviate discrimination) of coping. In light of our results, we would like to stress that the tension between educational and professional success experienced by academics with a migrant background – and the barriers and marginalization they continue to face – are essential issues to be introduced to socio-political discourse. It seems imperative to publicly accentuate the growing social, political and economic significance of this group, their educational aspirations, as well as their experiences of achievement and difficulties.

Keywords: coping strategies, discrimination, labor market, second generation university graduates

Procedia PDF Downloads 210
98 Gait Analysis in Total Knee Arthroplasty

Authors: Neeraj Vij, Christian Leber, Kenneth Schmidt

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Introduction: Total knee arthroplasty is a common procedure. It is well known that the biomechanics of the knee do not fully return to their normal state. Motion analysis has been used to study the biomechanics of the knee after total knee arthroplasty. The purpose of this scoping review is to summarize the current use of gait analysis in total knee arthroplasty and to identify the preoperative motion analysis parameters for which a systematic review aimed at determining the reliability and validity may be warranted. Materials and Methods: This IRB-exempt scoping review followed the Preferred Reporting Items for Systematic Reviews and Meta-Analyses extension for Scoping Reviews (PRISMA-ScR) checklist strictly. Five search engines were searched for a total of 279 articles. Articles underwent a title and abstract screening process followed by full-text screening. Included articles were placed in the following sections: the role of gait analysis as a research tool for operative decisions, other research applications for motion analysis in total knee arthroplasty, gait analysis as a tool in predicting radiologic outcomes, gait analysis as a tool in predicting clinical outcomes. Results: Eleven articles studied gait analysis as a research tool in studying operative decisions. Motion analysis is currently used to study surgical approaches, surgical techniques, and implant choice. Five articles studied other research applications for motion analysis in total knee arthroplasty. Other research applications for motion analysis currently include studying the role of the unicompartmental knee arthroplasty and novel physical therapy protocols aimed at optimizing post-operative care. Two articles studied motion analysis as a tool for predicting radiographic outcomes. Preoperative gait analysis has identified parameters than can predict postoperative tibial component migration. 15 articles studied motion analysis in conjunction with clinical scores. Conclusions: There is a broad range of applications within the research domain of total knee arthroplasty. The potential application is likely larger. However, the current literature is limited by vague definitions of ‘gait analysis’ or ‘motion analysis’ and a limited number of articles with preoperative and postoperative functional and clinical measures. Knee adduction moment, knee adduction impulse, total knee range of motion, varus angle, cadence, stride length, and velocity have the potential for integration into composite clinical scores. A systematic review aimed at determining the validity, reliability, sensitivities, and specificities of these variables is warranted.

Keywords: motion analysis, joint replacement, patient-reported outcomes, knee surgery

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97 Inpatient Drug Related Problems and Pharmacist Intervention at a Tertiary Care Teaching Hospital in South India: A Retrospective Study

Authors: Bollu Mounica

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Background: Nowadays drug related problems were seen very commonly within the health care practice. These could result in the medication errors, adverse events, drug interactions and harm to patients. Pharmacist has an identified role in minimizing and preventing such type of problems. Objectives: To detect the incidence of drug related problems for the hospitalized patient, and to analyze the clinical pharmacist interventions performed during the review of prescription orders of the general medicine, psychiatry, surgery, pediatrics, gynaecology units of a large tertiary care teaching hospital. Methods: It was a retrospective, observational and interventional study. The analysis took place daily with the following parameters: dose, rate of administration, presentation and/or dosage form, presence of inappropriate/unnecessary drugs, necessity of additional medication, more proper alternative therapies, presence of relevant drug interactions, inconsistencies in prescription orders, physical-chemical incompatibilities/solution stability. From this evaluation, the drug therapy problems were classified, as well as the resulting clinical interventions. For a period starting November 2012 until December 2014, the inpatient medication charts and orders were identified and rectified by ward and practicing clinical pharmacists within the inpatient pharmacy services in a tertiary care teaching hospital on routine daily activities. Data was collected and evaluated. The causes of this problem were identified. Results: A total of 360 patients were followed. Male (71.66%) predominance was noted over females (28.33%). Drug related problems were more commonly seen in patients aged in between 31-60. Most of the DRP observed in the study resulted from the dispensing errors (26.11%), improper drug selection (17.22%), followed by untreated indications (14.4%) Majority of the clinical pharmacist recommendations were on need for proper dispensing (26.11%), and drug change (18.05%). Minor significance of DRPs were noted high (41.11 %), whereas (35.27 %) were moderate and (23.61 %) were major. The acceptance rate of intervening clinical pharmacist recommendation and change in drug therapy was found to be high (86.66%). Conclusion: Our study showed that the prescriptions reviewed had some drug therapy problem and the pharmacist interventions have promoted positive changes needed in the prescriptions. In this context, routine participation of clinical pharmacists in clinical medical rounds facilitates the identification of DRPs and may prevent their occurrence.

Keywords: drug related problems, clinical pharmacist, drug prescriptions, drug related problems, intervention

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96 The Use of the TRIGRS Model and Geophysics Methodologies to Identify Landslides Susceptible Areas: Case Study of Campos do Jordao-SP, Brazil

Authors: Tehrrie Konig, Cassiano Bortolozo, Daniel Metodiev, Rodolfo Mendes, Marcio Andrade, Marcio Moraes

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Gravitational mass movements are recurrent events in Brazil, usually triggered by intense rainfall. When these events occur in urban areas, they end up becoming disasters due to the economic damage, social impact, and loss of human life. To identify the landslide-susceptible areas, it is important to know the geotechnical parameters of the soil, such as cohesion, internal friction angle, unit weight, hydraulic conductivity, and hydraulic diffusivity. The measurement of these parameters is made by collecting soil samples to analyze in the laboratory and by using geophysical methodologies, such as Vertical Electrical Survey (VES). The geophysical surveys analyze the soil properties with minimal impact in its initial structure. Statistical analysis and mathematical models of physical basis are used to model and calculate the Factor of Safety for steep slope areas. In general, such mathematical models work from the combination of slope stability models and hydrological models. One example is the mathematical model TRIGRS (Transient Rainfall Infiltration and Grid-based Regional Slope- Stability Model) which calculates the variation of the Factor of Safety of a determined study area. The model relies on changes in pore-pressure and soil moisture during a rainfall event. TRIGRS was written in the Fortran programming language and associates the hydrological model, which is based on the Richards Equation, with the stability model based on the principle of equilibrium limit. Therefore, the aims of this work are modeling the slope stability of Campos do Jordão with TRIGRS, using geotechnical and geophysical methodologies to acquire the soil properties. The study area is located at southern-east of Sao Paulo State in the Mantiqueira Mountains and has a historic landslide register. During the fieldwork, soil samples were collected, and the VES method applied. These procedures provide the soil properties, which were used as input data in the TRIGRS model. The hydrological data (infiltration rate and initial water table height) and rainfall duration and intensity, were acquired from the eight rain gauges installed by Cemaden in the study area. A very high spatial resolution digital terrain model was used to identify the slopes declivity. The analyzed period is from March 6th to March 8th of 2017. As results, the TRIGRS model calculates the variation of the Factor of Safety within a 72-hour period in which two heavy rainfall events stroke the area and six landslides were registered. After each rainfall, the Factor of Safety declined, as expected. The landslides happened in areas identified by the model with low values of Factor of Safety, proving its efficiency on the identification of landslides susceptible areas. This study presents a critical threshold for landslides, in which an accumulated rainfall higher than 80mm/m² in 72 hours might trigger landslides in urban and natural slopes. The geotechnical and geophysics methods are shown to be very useful to identify the soil properties and provide the geological characteristics of the area. Therefore, the combine geotechnical and geophysical methods for soil characterization and the modeling of landslides susceptible areas with TRIGRS are useful for urban planning. Furthermore, early warning systems can be developed by combining the TRIGRS model and weather forecast, to prevent disasters in urban slopes.

Keywords: landslides, susceptibility, TRIGRS, vertical electrical survey

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95 The Situation of Transgender Individuals Was Worsened During Covid-19

Authors: Kajal Attri

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Introduction: Transgender people are considered third gender in India, although they still face identification issues and alienated from society. Furthermore, they face several challenges, including discrimination in employment, resources, education, and property as a result, most transgender people make a living through begging at traffic lights, trains, and buses; attending auspicious occasions such as childbirth and weddings; and engaging in sex work, which includes both home-based and street-based sex work. During COVID-19, maintaining social distance exacerbates transgender people's circumstances and prevents them from accessing health care services, sexual reassignment surgery, identity-based resources, government security, and financial stability. Nonetheless, the pandemic raised unfavorable attitudes about transgender persons, such as unsupportive family members and trouble forming emotional relationships. This study focuses on how we missed transgender people during COVID-19 to provide better facilities to cope with this situation when they are already the most vulnerable segment of the society. Methodology: The research was conducted using secondary data from published publications and grey literature obtained from four databases: Pubmed, Psychinfo, Science direct, and Google scholar. The literature included total 25 articles that met the inclusion criteria for a review. Result and Discussion: Transgender people, who are considered the most vulnerable sector of society, have already faced several obstacles as a result of the outbreak. The analysis underscores the difficulties that transgender persons faced during COVID-19, such as, They had trouble accessing the government's social security programmes during the lockdown, which provide rations and pensions since they lack the necessary identifying cards. The impact of COVID-19 leaves transgender people at heightened risk of poverty and ill health because they exist on the margins of society, those livelihood base on sex work, begging, and participation on auspicious occasions. They had a significant risk of contracting SARS-CoV2 because they lived in congested areas or did not have permanent shelter, and they were predominantly infected with HIV, cancer, and other non-communicable illnesses. The pandemic raised unfavorable attitudes about transgender persons, such as unsupportive family members and trouble forming emotional relationships. Conclusion: The study comes forward with useful suggestions based on content analysis and information to reduce the existing woes of transgenders during any pandemic like COVID-19.

Keywords: COVID-19, transgender, lockdown, transwomen, stigmatization

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94 Working at the Interface of Health and Criminal Justice: An Interpretative Phenomenological Analysis Exploration of the Experiences of Liaison and Diversion Nurses – Emerging Findings

Authors: Sithandazile Masuku

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Introduction: Public health approaches to offender mental health are driven by international policies and frameworks in response to the disproportionately large representation of people with mental health problems within the offender pathway compared to the general population. Public health service innovations include mental health courts in the US, restorative models in Singapore and, liaison and diversion services in Australia, the UK, and some other European countries. Mental health nurses are at the forefront of offender health service innovations. In the U.K. context, police custody has been identified as an early point within the offender pathway where nurses can improve outcomes by offering assessments and share information with criminal justice partners. This scope of nursing practice has introduced challenges related to skills and support required for nurses working at the interface of health and the criminal justice system. Parallel literature exploring experiences of nurses working in forensic settings suggests the presence of compassion fatigue, burnout and vicarious trauma that may impede risk harm to the nurses in these settings. Published research explores mainly service-level outcomes including monitoring of figures indicative of a reduction in offending behavior. There is minimal research exploring the experiences of liaison and diversion nurses who are situated away from a supportive clinical environment and engaged in complex autonomous decision-making. Aim: This paper will share qualitative findings (in progress) from a PhD study that aims to explore the experiences of liaison and diversion nurses in one service in the U.K. Methodology: This is a qualitative interview study conducted using an Interpretative Phenomenological Analysis to gain an in-depth analysis of lived experiences. Methods: A purposive sampling technique was used to recruit n=8 mental health nurses registered with the UK professional body, Nursing and Midwifery Council, from one UK Liaison and Diversion service. All participants were interviewed online via video call using semi-structured interview topic guide. Data were recorded and transcribed verbatim. Data were analysed using the seven steps of the Interpretative Phenomenological Analysis data analysis method. Emerging Findings Analysis to date has identified pertinent themes: • Difficulties of meaning-making for nurses because of the complexity of their boundary spanning role. • Emotional burden experienced in a highly emotive and fast-changing environment. • Stress and difficulties with role identity impacting on individual nurses’ ability to be resilient. • Challenges to wellbeing related to a sense of isolation when making complex decisions. Conclusion Emerging findings have highlighted the lived experiences of nurses working in liaison and diversion as challenging. The nature of the custody environment has an impact on role identity and decision making. Nurses left feeling isolated and unsupported are less resilient and may go on to experience compassion fatigue. The findings from this study thus far point to a need to connect nurses working in these boundary spanning roles with a supportive infrastructure where the complexity of their role is acknowledged, and they can be connected with a health agenda. In doing this, the nurses would be protected from harm and the likelihood of sustained positive outcomes for service users is optimised.

Keywords: liaison and diversion, nurse experiences, offender health, staff wellbeing

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93 Chronic wrist pain among handstand practitioners. A questionnaire study.

Authors: Martonovich Noa, Maman David, Alfandari Liad, Behrbalk Eyal.

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Introduction: The human body is designed for upright standing and walking, with the lower extremities and axial skeleton supporting weight-bearing. Constant weight-bearing on joints not meant for this action can lead to various pathologies, as seen in wheelchair users. Handstand practitioners use their wrists as weight-bearing joints during activities, but little is known about wrist injuries in this population. This study aims to investigate the epidemiology of wrist pain among handstand practitioners, as no such data currently exist. Methods: The study is a cross-sectional online survey conducted among athletes who regularly practice handstands. Participants were asked to complete a three-part questionnaire regarding their workout regimen, training habits, and history of wrist pain. The inclusion criteria were athletes over 18 years old who practice handstands more than twice a month for at least 4 months. All data were collected using Google Forms, organized and anonymized using Microsoft Excel, and analyzed using IBM SPSS 26.0. Descriptive statistics were calculated, and potential risk factors were tested using asymptotic t-tests and Fisher's tests. Differences were considered significant when p < 0.05. Results: This study surveyed 402 athletes who regularly practice handstands to investigate the prevalence of chronic wrist pain and potential risk factors. The participants had a mean age of 31.3 years, with most being male and having an average of 5 years of training experience. 56% of participants reported chronic wrist pain, and 14.4% reported a history of distal radial fracture. Yoga was the most practiced form, followed by Capoeira. No significant differences were found in demographic data between participants with and without chronic wrist pain, and no significant associations were found between chronic wrist pain prevalence and warm-up routines or protective aids. Conclusion: The lower half of the body is meant to handle weight-bearing and impact, while transferring the load to upper extremities can lead to various pathologies. Athletes who perform handstands are particularly prone to chronic wrist pain, which affects over half of them. Warm-up sessions and protective instruments like wrist braces do not seem to prevent chronic wrist pain, and there are no significant differences in age or training volume between athletes with and without the condition. Further research is needed to understand the causes of chronic wrist pain in athletes, given the growing popularity of sports and activities that can cause this type of injury.

Keywords: handstand, handbalance, wrist pain, hand and wrist surgery, yoga, calisthenics, circus, capoeira, movement.

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92 Delivering Safer Clinical Trials; Using Electronic Healthcare Records (EHR) to Monitor, Detect and Report Adverse Events in Clinical Trials

Authors: Claire Williams

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Randomised controlled Trials (RCTs) of efficacy are still perceived as the gold standard for the generation of evidence, and whilst advances in data collection methods are well developed, this progress has not been matched for the reporting of adverse events (AEs). Assessment and reporting of AEs in clinical trials are fraught with human error and inefficiency and are extremely time and resource intensive. Recent research conducted into the quality of reporting of AEs during clinical trials concluded it is substandard and reporting is inconsistent. Investigators commonly send reports to sponsors who are incorrectly categorised and lacking in critical information, which can complicate the detection of valid safety signals. In our presentation, we will describe an electronic data capture system, which has been designed to support clinical trial processes by reducing the resource burden on investigators, improving overall trial efficiencies, and making trials safer for patients. This proprietary technology was developed using expertise proven in the delivery of the world’s first prospective, phase 3b real-world trial, ‘The Salford Lung Study, ’ which enabled robust safety monitoring and reporting processes to be accomplished by the remote monitoring of patients’ EHRs. This technology enables safety alerts that are pre-defined by the protocol to be detected from the data extracted directly from the patients EHR. Based on study-specific criteria, which are created from the standard definition of a serious adverse event (SAE) and the safety profile of the medicinal product, the system alerts the investigator or study team to the safety alert. Each safety alert will require a clinical review by the investigator or delegate; examples of the types of alerts include hospital admission, death, hepatotoxicity, neutropenia, and acute renal failure. This is achieved in near real-time; safety alerts can be reviewed along with any additional information available to determine whether they meet the protocol-defined criteria for reporting or withdrawal. This active surveillance technology helps reduce the resource burden of the more traditional methods of AE detection for the investigators and study teams and can help eliminate reporting bias. Integration of multiple healthcare data sources enables much more complete and accurate safety data to be collected as part of a trial and can also provide an opportunity to evaluate a drug’s safety profile long-term, in post-trial follow-up. By utilising this robust and proven method for safety monitoring and reporting, a much higher risk of patient cohorts can be enrolled into trials, thus promoting inclusivity and diversity. Broadening eligibility criteria and adopting more inclusive recruitment practices in the later stages of drug development will increase the ability to understand the medicinal products risk-benefit profile across the patient population that is likely to use the product in clinical practice. Furthermore, this ground-breaking approach to AE detection not only provides sponsors with better-quality safety data for their products, but it reduces the resource burden on the investigator and study teams. With the data taken directly from the source, trial costs are reduced, with minimal data validation required and near real-time reporting enables safety concerns and signals to be detected more quickly than in a traditional RCT.

Keywords: more comprehensive and accurate safety data, near real-time safety alerts, reduced resource burden, safer trials

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