Search results for: clinical research (CRE)
Commenced in January 2007
Frequency: Monthly
Edition: International
Paper Count: 27076

Search results for: clinical research (CRE)

26176 Telehealth Psychotherapy: A Comparison of Two Swedish Randomized Clinical Trials

Authors: Madeline Foster

Abstract:

Since the COVID-19 pandemic, telehealth usage for the delivery of psychotherapy has surged. The evidence base evaluating the success of telehealth interventions continues to grow, with both benefits as well as potential risks identified. This study compared two recent randomized clinical trials (RCTs) from Sweden that looked at the effectiveness of Cognitive Behavioral Therapy (CBT) delivered via telehealth (TH) versus face-to-face (FTF) for individuals with Obsessive Compulsive Disorder (OCD). The papers had mixed results. The first paper by Aspvall and colleagues compared the effect of a therapist-supported, internet-delivered stepped-care CBT program for children and adolescents aged 7 to 17 with face-to-face CBT (2021). In Aspvall’s study, the control scored a mean Y-BOCS of 10.57 and the TH intervention group scored a mean Y-BOCS of 11.57. The mean difference (0.91) met the criteria for noninferiority (p = 0.03). The second study by Lundström and colleagues also compared therapist-supported, internet-based CBT with FTF CBT for the treatment of those with DSM-5-diagnosed OCD. Conversely, while Lundström’s study reported improved symptoms across all groups, at follow up the difference in symptom severity between FTF and TH was clinically significant, with 77% of FTF participants responding to treatment compared to only 45% of TH participants. Due to the methodological limitations of Lundström’s study, it was concluded that Aspvall’s paper made a stronger scientific argument.

Keywords: telehealth, Sweden, RCT, cognitive-behavioral therapy, obsessive-compulsive disorder

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26175 Quality of Life Assessment across the Cancer Continuum: Understanding the Role of an Exercise Rehabilitation Programme

Authors: Bernat-Carles Serdà Ferrer, Arantza Del Valle Gómez

Abstract:

The Quality of Life (QoL) paradigm is multidimensional, dynamic and modular and its definition differs across the cancer continuum. The challenge in the interpretation of QoL data in clinical research is that QoL is influenced by psychological phenomena such as adaptation to illness. This research aims to obtain a valid and sensitive assessment of QoL change over the continuum disease, and to evaluate a rehabilitation programme aimed at inverting the observed decrease in QoL when patients return to daily living activities. The sample comprised 66 men. Patients were first assessed to establish a baseline (P1-diagnosis). This was followed by a post-test (P2-discharge) and a then-test measurement (P3-retrospective evaluation) and after returning home patients were randomized in experimental and control groups. The experimental group attended a rehabilitation programme over 24 weeks (P4). Results show that from baseline to post-test, QoL decreased significantly. The recalibration then-test confirmed a low QoL in all periods evaluated. Significant differences between the experimental and control groups prove the positive effect of the Exercise Rehabilitation Programme (ERP) on QoL. Understanding the real dynamic of QoL over time would help to adapt rehabilitation programmes by improving sensitivity and efficacy and provide professionals with a more accurate perception of the impact of treatment and side effects on patients’ QoL. Our results underline the importance of changing the approach adopted by health professionals towards one of watchful waiting on patients’ QoL until their complete recovery in daily life.

Keywords: exercise, prostate cancer, quality of life, rehabilitation programme, response shift

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26174 Patterns of Eosinophilia in Cardiac Patients and its Association with Endomyocardial Disease Presenting to Tertiary Care Hospital in Peshawar

Authors: Rashid Azeem

Abstract:

Introduction: Eosinophilia, which can be categorized as mild, moderate, and severe form on the basis of increasing eosinophil counts, might be responsible for a wide range of cardiac manifestations, varying from a simple myocarditis to a severe state like endomyocardial fibrosis. Eosinophils are involved in the pathogenesis of a variety of cardiovascular disorder like Loffler endocarditis, eosinophilic granulomatosis with polyangitis (EGPH), and hyper eosinophilic (HES). Among them HES carries and incidence rate b/w 48% and 75% and is the main causes of cardiac motility and mobility due to eosinophilia involvement. Aims and objectives: The aim of this study is to determine the frequency of eosinophilia in cardiac patients and to ascertain the evidence of endomyocardial diseases in eosinophilic patients in a cardiology institution Material and Methods: This cross sectional analytical study was conducted in hematology Department of Peshawar institute of Cardiology after approval from hospital ethical and research committee. All 70 patients were subjected to detailed history and clinical examination. Investigation like CBC, Chest X-ray, ECG, Echo, Angiography findings were used to monitor patient’s clinical status. Data is analyzed using SPSS version 25 and MS Excel. Results: Out of 70 patients in our study, a total of 66 patients(94 %) shows evidence of cardiac manifestations. In our study, we have observed a number of abnormal ECG patterns in cardiac patients presenting with eosinophilia, like T wave changes, loss of R wave, sinus bradycardia with LVH strain, and ST wave abnormality. abnormal echocardiographic findings were observed in our patients, like valvular abnormalities (in 45.7%), RWMA abnormalities (in 2.8%), isolated ventricular dysfunction (in 21.4%), and in 10% patients, normal echocardiography. We further noted abnormal coronary angiography findings in cardiac patients with eosinophilia ranging from single vessel to multi vessel occlusions. Conclusions: Eosinophils are involved in the pathogenesis of a variety of cardiovascular disorders which can be detected by various diagnostic means, and the severity of the disease increases with time and with increasing eosinophil count ranging from simple myocarditis to a fatal condition like endomyocardial fibrosis. Thus, increased eosinophilic count as a laboratory parameter in cardiac patients may be a sign of endomyocardial damage which will further help cardiologist to intervene more aggressively then routine approach to a cardiac patient.

Keywords: eosinophilia, endomyocardial fibrosis, cardiac, hypereosinophilic syndrome

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26173 Brazilian Sign Language: A Synthesis of the Research in the Period from 2000 to 2017

Authors: Maria da Gloria Guara-Tavares

Abstract:

This article reports a synthesis of the research in Brazilian Sign Language conducted from 2000 to 2017. The objective of the synthesis was to identify the most researched areas and the most used methodologies. Articles published in three Brazilian journals of Translation Studies, unpublished dissertations and theses were included in the analysis. Abstracts and the method sections of the papers were scrutinized. Sixty studies were analyzed, and overall results indicate that the research in Brazilian Sign Language has been fragmented in several areas such as linguistic aspects, facial expressions, subtitling, identity issues, bilingualism, and interpretation strategies. Concerning research methods, the synthesis reveals that most research is qualitative in nature. Moreover, results show that the cognitive aspects of Brazilian Sign Language seem to be poorly explored. Implications for a future research agenda are also discussed.

Keywords: Brazilian sign language, qualitative methods, research agenda, synthesis

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26172 Leveraging Remote Assessments and Central Raters to Optimize Data Quality in Rare Neurodevelopmental Disorders Clinical Trials

Authors: Pamela Ventola, Laurel Bales, Sara Florczyk

Abstract:

Background: Fully remote or hybrid administration of clinical outcome measures in rare neurodevelopmental disorders trials is increasing due to the ongoing pandemic and recognition that remote assessments reduce the burden on families. Many assessments in rare neurodevelopmental disorders trials are complex; however, remote/hybrid trials readily allow for the use of centralized raters to administer and score the scales. The use of centralized raters has many benefits, including reducing site burden; however, a specific impact on data quality has not yet been determined. Purpose: The current study has two aims: a) evaluate differences in data quality between administration of a standardized clinical interview completed by centralized raters compared to those completed by site raters and b) evaluate improvement in accuracy of scoring standardized developmental assessments when scored centrally compared to when scored by site raters. Methods: For aim 1, the Vineland-3, a widely used measure of adaptive functioning, was administered by site raters (n= 52) participating in one of four rare disease trials. The measure was also administered as part of two additional trials that utilized central raters (n=7). Each rater completed a comprehensive training program on the assessment. Following completion of the training, each clinician completed a Vineland-3 with a mock caregiver. Administrations were recorded and reviewed by a neuropsychologist for administration and scoring accuracy. Raters were able to certify for the trials after demonstrating an accurate administration of the scale. For site raters, 25% of each rater’s in-study administrations were reviewed by a neuropsychologist for accuracy of administration and scoring. For central raters, the first two administrations and every 10th administration were reviewed. Aim 2 evaluated the added benefit of centralized scoring on the accuracy of scoring of the Bayley-3, a comprehensive developmental assessment widely used in rare neurodevelopmental disorders trials. Bayley-3 administrations across four rare disease trials were centrally scored. For all administrations, the site rater who administered the Bayley-3 scored the scale, and a centralized rater reviewed the video recordings of the administrations and also scored the scales to confirm accuracy. Results: For aim 1, site raters completed 138 Vineland-3 administrations. Of the138 administrations, 53 administrations were reviewed by a neuropsychologist. Four of the administrations had errors that compromised the validity of the assessment. The central raters completed 180 Vineland-3 administrations, 38 administrations were reviewed, and none had significant errors. For aim 2, 68 administrations of the Bayley-3 were reviewed and scored by both a site rater and a centralized rater. Of these administrations, 25 had errors in scoring that were corrected by the central rater. Conclusion: In rare neurodevelopmental disorders trials, sample sizes are often small, so data quality is critical. The use of central raters inherently decreases site burden, but it also decreases rater variance, as illustrated by the small team of central raters (n=7) needed to conduct all of the assessments (n=180) in these trials compared to the number of site raters (n=53) required for even fewer assessments (n=138). In addition, the use of central raters dramatically improves the quality of scoring the assessments.

Keywords: neurodevelopmental disorders, clinical trials, rare disease, central raters, remote trials, decentralized trials

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26171 The Correlation between Head of Bed Angle and IntraAbdominal Pressure of Intubated Patients; a Pre-Post Clinical Trial

Authors: Sedigheh Samimian, Sadra Ashrafi, Tahereh Khaleghdoost Mohammadi, Mohammad Reza Yeganeh, Ali Ashraf, Hamideh Hakimi, Maryam Dehghani

Abstract:

Introduction: The recommended position for measuring Intra-Abdominal Pressure (IAP) is the supine position. However, patients put in this position are prone to Ventilator-associated pneumonia. This study was done to evaluate the relationship between bed head angle and IAP measurements of intubated patients in the intensive care unit. Methods: In this clinical trial, seventy-six critically ill patients under mechanical ventilation were enrolled. IAP measurement was performed every 8 hours for 24 hours using the KORN method in three different degrees of the head of bed (HOB) elevation (0°, 15°, and 30°). Bland-Altman analysis was performed to identify the bias and limits of agreement among the three HOBs. According to World Society of the Abdominal Compartment Syndrome (WSACS), we can consider two IAP techniques equivalent if a bias of <1 mmHg and limits of agreement of - 4 to +4 were found between them. Data were analyzed using SPSS statistical software (v. 19), and the significance level was considered as 0.05. Results: The prevalence of intra-abdominal hypertension was 18.42%. Mean ± standard deviation (SD) of IAP were 8.44 ± 4.02 mmHg for HOB angle 0°, 9.58 ± 4.52 for HOB angle 15°, and 11.10 ± 4.73 for HOB angle 30o (p = 0.0001). The IAP measurement bias between HOB angle 0◦ and HOB angle 15° was 1.13 mmHg. This bias was 2.66 mmHg between HOB angle 0° and HOB angle 30°. Conclusion: Elevation of HOB angle from 0 to 30 degree significantly increases IAP. It seems that the measurement of IAP at HOB angle 15° was more reliable than 30°.

Keywords: pressure, intra-abdominal hypertension, head of bed, critical care, compartment syndrome, supine position

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26170 Compliance of Systematic Reviews in Plastic Surgery with the PRISMA Statement: A Systematic Review

Authors: Seon-Young Lee, Harkiran Sagoo, Katherine Whitehurst, Georgina Wellstead, Alexander Fowler, Riaz Agha, Dennis Orgill

Abstract:

Introduction: Systematic reviews attempt to answer research questions by synthesising the data within primary papers. They are an increasingly important tool within evidence-based medicine, guiding clinical practice, future research and healthcare policy. We sought to determine the reporting quality of recent systematic reviews in plastic surgery. Methods: This systematic review was conducted in line with the Cochrane handbook, reported in line with the PRISMA statement and registered at the ResearchRegistry (UIN: reviewregistry18). MEDLINE and EMBASE databases were searched in 2013 and 2014 for systematic reviews by five major plastic surgery journals. Screening, identification and data extraction was performed independently by two teams. Results: From an initial set of 163 articles, 79 met the inclusion criteria. The median PRISMA score was 16 out of 27 items (59.3%; range 6-26, 95% CI 14-17). Compliance between individual PRISMA items showed high variability. It was poorest for items related to the use of review protocol (item 5; 5%) and presentation of data on risk of bias of each study (item 19; 18%), while being the highest for description of rationale (item 3; 99%) and sources of funding and other support (item 27; 95%), and for structured summary in the abstract (item 2; 95%). Conclusion: The reporting quality of systematic reviews in plastic surgery requires improvement. ‘Hard-wiring’ of compliance through journal submission systems, as well as improved education, awareness and a cohesive strategy among all stakeholders is called for.

Keywords: PRISMA, reporting quality, plastic surgery, systematic review, meta-analysis

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26169 Childhood Cataract: A Socio-Clinical Study at a Public Sector Tertiary Eye Care Centre in India

Authors: Deepak Jugran, Rajesh Gill

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Purpose: To study the demographic, sociological, gender and clinical profile of the children presented for childhood cataract at a public sector tertiary eye care centre in India. Methodology: The design of the study is retrospective, and hospital-based data is available with the Central Registration Department of the PGIMER, Chandigarh. The majority of the childhood cataract cases are being reported in this hospital, yet not each and every case of childhood cataract approaches PGI, Chandigarh. Nevertheless, this study is going to be pioneering research in India, covering five-year data of the childhood cataract patients who visited the Advanced Eye Centre, PGIMER, Chandigarh, from 1.1.2015 to 31.12.2019. The SPSS version 23 was used for all statistical calculations. Results: A Total of 354 children were presented for childhood cataract from 1.1.2015 to 31.12.2019. Out of 354 children, 248 (70%) were male, and 106 (30%) were female. In-spite of 2 flagship programmes, namely the National Programme for Control of Blindness (NPCB) and Aayushman Bharat (PM JAY) for eradication of cataract, no children received any financial assistance from these two programmes. A whopping 99% of these children belong to the poor families. In most of these families, the mothers were house-wives and did not employ anywhere. These interim results will soon be conveyed to the Govt. of India so that a suitable mechanism can be evolved to address this pertinent issue. Further, the disproportionate ratio of male and female children in this study is an area of concern as we don’t know whether the prevalence of childhood cataract is lower in female children or they are not being presented on time in the hospital by the families. Conclusion: The World Health Organization (WHO) has categorized Childhood blindness resulting from cataract as a priority area and urged all member countries to develop institutionalized mechanisms for its early detection, diagnosis and management. The childhood cataract is an emerging and major cause of preventable and avoidable childhood blindness, especially in low and middle-income countries. In the formative years, the children require a sound physical, mental and emotional state, and in the absence of either one of them, it can severely dent their future growth. The recent estimate suggests that India could suffer an economic loss of US$12 billion (Rs. 88,000 Crores) due to blindness, and almost 35% of cases of blindness are preventable and avoidable if detected at an early age. Besides reporting these results to the policy makers, synchronized efforts are needed for early detection and management of avoidable causes of childhood blindness such as childhood cataract.

Keywords: childhood blindness, cataract, Who, Npcb

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26168 Dueling Burnout: The Dual Role Nurse

Authors: Melissa Dorsey

Abstract:

Moral distress and compassion fatigue plague nurses in the Cardiothoracic Intensive Care Unit (CTICU) and cause an unnecessary level of turnover. Dueling Burnout describes an initiative that was implemented in the CTICU to reduce the level of burnout the nurses endure by encouraging dual roles with collaborating departments. Purpose: Critical care nurses are plagued by burnout, moral distress, and compassion fatigue due to the intensity of care provided. The purpose of the dual role program was to decrease these issues by providing relief from the intensity of the critical care environment while maintaining full-time employment. Relevance/Significance: Burnout, moral distress, and compassion fatigue are leading causes of Cardiothoracic Critical Care (CTCU) turnover. A contributing factor to burnout is the workload related to serving as a preceptor for a constant influx of new nurses (RN). As a result of these factors, the CTICU averages 17% nursing turnover/year. The cost, unit disruption, and, most importantly, distress of the clinical nurses required an innovative approach to create an improved work environment and experience. Strategies/Implementation/Methods: In May 2018, a dual role pilot was initiated for nurses. The dual role constitutes .6 full-time equivalent hours (FTE) worked in CTICU in combination with .3 FTE worked in the Emergency Department (ED). ED nurses who expressed an interest in cross-training to CTICU were also offered the dual role opportunity. The initial hypothesis was that full-time employees would benefit from a change in clinical setting leading to increased engagement and job satisfaction. The dual role also presents an opportunity for professional development through the expansion of clinical skills in another specialty. Success of the pilot led to extending the dual role to areas beyond the ED. Evaluation/Outcomes/Results: The number of dual role clinical nurses has grown to 22. From the dual role cohort, only one has transferred out of CTICU. This is a 5% turnover rate for this group of nurses as compared to the average turnover rate of 17%. A role satisfaction survey conducted with the dual role cohort found that because of working in a dual role, 76.5% decreased their intent to leave, 100% decreased their level of burnout, and 100% reported an increase in overall job satisfaction. Nurses reported the ability to develop skills that are transferable between departments. Respondents emphasized the appreciation gained from working in multiple environments; the dual role served to transform their care. Conclusions/Implications: Dual role is an effective strategy to retain experienced nurses, decrease burnout and turnover, improve collaboration, and provide flexibility to meet staffing needs. The dual role offers RNs an expansion of skills, relief from high acuity and orientee demands, while improving job satisfaction.

Keywords: nursing retention, burnout, pandemic, strategic staffing, leadership

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26167 Developing Research Involving Different Species: Opportunities and Empirical Foundations

Authors: A. V. Varfolomeeva, N. S. Tkachenko, A. G. Tishchenko

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The problem of violation of internal validity in studies of psychological structures is considered. The role of epistemological attitudes of researchers in the planning of research within the methodology of the system-evolutionary approach is assessed. Alternative programs of psychological research involving representatives of different biological species are presented. On the example of the results of two research series the variants of solving the problem are discussed.

Keywords: epistemological attitudes, experimental design, validity, psychological structure, learning

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26166 Post-bladder Catheter Infection

Authors: Mahla Azimi

Abstract:

Introduction: Post-bladder catheter infection is a common and significant healthcare-associated infection that affects individuals with indwelling urinary catheters. These infections can lead to various complications, including urinary tract infections (UTIs), bacteremia, sepsis, and increased morbidity and mortality rates. This article aims to provide a comprehensive review of post-bladder catheter infections, including their causes, risk factors, clinical presentation, diagnosis, treatment options, and preventive measures. Causes and Risk Factors: Post-bladder catheter infections primarily occur due to the colonization of microorganisms on the surface of the urinary catheter. The most common pathogens involved are Escherichia coli, Klebsiella pneumoniae, Pseudomonas aeruginosa, and Enterococcus species. Several risk factors contribute to the development of these infections, such as prolonged catheterization duration, improper insertion technique, poor hygiene practices during catheter care, compromised immune system function in patients with underlying conditions or immunosuppressive therapy. Clinical Presentation: Patients with post-bladder catheter infections may present with symptoms such as fever, chills, malaise, suprapubic pain or tenderness, and cloudy or foul-smelling urine. In severe cases or when left untreated for an extended period of time, patients may develop more severe symptoms like hematuria or signs of systemic infection. Diagnosis: The diagnosis of post-bladder catheter infection involves a combination of clinical evaluation and laboratory investigations. Urinalysis is crucial in identifying pyuria (presence of white blood cells) and bacteriuria (presence of bacteria). A urine culture is performed to identify the causative organism(s) and determine its antibiotic susceptibility profile. Treatment Options: Prompt initiation of appropriate antibiotic therapy is essential in managing post-bladder catheter infections. Empirical treatment should cover common pathogens until culture results are available. The choice of antibiotics should be guided by local antibiogram data to ensure optimal therapy. In some cases, catheter removal may be necessary, especially if the infection is recurrent or associated with severe complications. Preventive Measures: Prevention plays a vital role in reducing the incidence of post-bladder catheter infections. Strategies include proper hand hygiene, aseptic technique during catheter insertion and care, regular catheter maintenance, and timely removal of unnecessary catheters. Healthcare professionals should also promote patient education regarding self-care practices and signs of infection. Conclusion: Post-bladder catheter infections are a significant healthcare concern that can lead to severe complications and increased healthcare costs. Early recognition, appropriate diagnosis, and prompt treatment are crucial in managing these infections effectively. Implementing preventive measures can significantly reduce the incidence of post-bladder catheter infections and improve patient outcomes. Further research is needed to explore novel strategies for prevention and management in this field.

Keywords: post-bladder catheter infection, urinary tract infection, bacteriuria, indwelling urinary catheters, prevention

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26165 Improving Our Understanding of the in vivo Modelling of Psychotic Disorders

Authors: Zsanett Bahor, Cristina Nunes-Fonseca, Gillian L. Currie, Emily S. Sena, Lindsay D.G. Thomson, Malcolm R. Macleod

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Psychosis is ranked as the third most disabling medical condition in the world by the World Health Organization. Despite a substantial amount of research in recent years, available treatments are not universally effective and have a wide range of adverse side effects. Since many clinical drug candidates are identified through in vivo modelling, a deeper understanding of these models, and their strengths and limitations, might help us understand reasons for difficulties in psychosis drug development. To provide an unbiased summary of the preclinical psychosis literature we performed a systematic electronic search of PubMed for publications modelling a psychotic disorder in vivo, identifying 14,721 relevant studies. Double screening of 11,000 publications from this dataset so far established 2403 animal studies of psychosis, with the most common model being schizophrenia (95%). 61% of these models are induced using pharmacological agents. For all the models only 56% of publications test a therapeutic treatment. We propose a systematic review of these studies to assess the prevalence of reporting of measures to reduce risk of bias, and a meta-analysis to assess the internal and external validity of these animal models. Our findings are likely to be relevant to future preclinical studies of psychosis as this generation of strong empirical evidence has the potential to identify weaknesses, areas for improvement and make suggestions on refinement of experimental design. Such a detailed understanding of the data which inform what we think we know will help improve the current attrition rate between bench and bedside in psychosis research.

Keywords: animal models, psychosis, systematic review, schizophrenia

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26164 A Cognitive Behavioural Therapy for Post-Traumatic Stress Disorders

Authors: Ryotaro Ishikawa

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INTRODUCTION: Post-traumatic stress disorder (PTSD) is a psychiatric label for a collection of psychological symptoms following a traumatic event. PTSD is as a result of a traumatic experience such as rape or sexual assault. A victim may have PTSD if she/he has experienced the following symptoms for at least a month: a) Stressor, b) Intrusion symptoms, c) Avoidance, d) Negative alterations in cognitions and mood, e) Alterations in arousal and reactivity. Studies on the cognitive theory of PTSD emphasized the roles of (a) negative appraisals of trauma memories in maintaining the symptomatology of PTSD, and (b) disorganized trauma memories in the development of PTSD. Mental contamination is primarily caused by experiences involving humans (e.g. violators or perpetrators) as opposed to substances (e.g. dirt or bodily fluids). Feelings of mental contamination may evoke following experiences of ill-treatment, sexual assault, domination, degradation, manipulation, betrayal, or humiliation. Some studies have demonstrated that traumatic thoughts related to sexual assault are particularly strong predictors of mental contamination. Treatment protocols based on cognitive-behavioral therapy appear to be beneficial in reducing the severity of PTSD and mental contamination. Studies on the cognitive theory of PTSD emphasized the roles of (A) negative appraisals of trauma memories in maintaining the symptomatology of PTSD, and (B) disorganized trauma memories in the development of PTSD. We will demonstrate a feasibility study of individual CBT for PTSD and mental contamination in Japanese clinical settings. METHOD: The single-arm trial is a group setting CBT intervention. The primary outcome is the self-rated Posttraumatic Stress Diagnostic Scale, with secondary measurements of depressive severity and mental pollution questionnaire. Assessments are conducted at baseline, after a waiting period before CBT, during CBT, and after CBT. RESULTS: Participants are eligible for the study and complete the outcome measures at all assessment points. In our hypothesis, receiving CBT would lead to improvements in primary and secondary PTSD severity. CONCLUSION: We will demonstrate a feasibility study of individual CBT for PTSD and mental contamination in Japanese clinical settings. Our treatment would achieve favorable treatment outcomes for PTSD with mental contamination in Japanese clinical settings.

Keywords: CBT, cognitive theory, PTSD, mental pollution

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26163 Nurses' Knowledge and Attitudes toward the Use of Physical Restraints

Authors: Fatema Salman, Ridha Hammam, Fatima Khairallah, Fatima Aradi, Nafeesa Abdulla, Mohammed Alsafar

Abstract:

Purpose: This study aims at measuring the extent of nurses’ knowledge and attitudes toward the use of physical restraints in different hospital wards at Salmaniya Medical Complex (SMC). Background: The habitual use of physical restraint is a widespread practice among nurses working in the clinical settings. Restraints inflict many deleterious consequences on patients physically and psychologically which in turn increases their morbidity and mortality risk and jeopardizes care quality. Nurses’ knowledge and attitudes toward physical restraints are crucial determinants of the persistence of this practice. Literature review: the evidence of lack of knowledge among nurses regarding the use of physical restraints is overwhelming in various clinical settings, especially in two main areas which are the negative consequences and the available alternatives to physical restraints. Studies explored nurses’ attitudes toward physical restraints yielded inconsistent findings. Equally comparable, some studies found that nurses hold positive attitudes toward the use of physical restraints while some others reported just the opposite. Methods: Self-administered knowledge and attitudes scales to 106 nurses working in the SMC. Findings: nurses hold the moderate level of knowledge about restraints (M=58%) with weak negative attitudes (M = -20%) toward using it. Significant moderately-strong negative correlation (r= -0.57, r2= 0.32, p= 0.000) was uncovered between nurses knowledge and their attitudes which provided an empirical explanation of this phenomenon (use of physical restraints). Recommendations: Induction of awareness program that especially focuses on the negative consequences and encourages the use of alternatives is an evident need. This effort necessarily should be adjoined with policy and procedure adjustments.

Keywords: attitudes, knowledge, nurses, restraints

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26162 Coffee Consumption Has No Acute Effects on Glucose Metabolism in Healthy Men: A Randomized Crossover Clinical Trial

Authors: Caio E. G. Reis, Sara Wassell, Adriana L. Porto, Angélica A. Amato, Leslie J. C. Bluck, Teresa H. M. da Costa

Abstract:

Background: Multiple epidemiologic studies have consistently reported association between increased coffee consumption and a lowered risk of Type 2 Diabetes Mellitus. However, the mechanisms behind this finding have not been fully elucidated. Objective: We investigate the effect of coffee (caffeinated and decaffeinated) on glucose effectiveness and insulin sensitivity using the stable isotope minimal model protocol with oral glucose administration in healthy men. Design: Fifteen healthy men underwent 5 arms randomized crossover single-blinding (researchers) clinical trial. They consumed decaffeinated coffee, caffeinated coffee (with and without sugar), and controls – water (with and without sugar) followed 1 hour by an oral glucose tolerance test (75 g of available carbohydrate) with intravenous labeled dosing interpreted by the two compartment minimal model (225 minutes). One-way ANOVA with Bonferroni adjustment were used to compare the effects of the tested beverages on glucose metabolism parameters. Results: Decaffeinated coffee resulted in 29% and 85% higher insulin sensitivity compared with caffeinated coffee and water, respectively, and the caffeinated coffee showed 15% and 60% higher glucose effectiveness compared with decaffeinated coffee and water, respectively. However, these differences were not significant (p > 0.10). In overall analyze (0 – 225 min) there were no significant differences on glucose effectiveness, insulin sensitivity, and glucose and insulin area under the curve between the groups. The beneficial effects of coffee did not seem to act in the short-term (hours) on glucose metabolism parameters mainly on insulin sensitivity indices. The benefits of coffee consumption occur in the long-term (years) as has been shown in the reduction of Type 2 Diabetes Mellitus risk in epidemiological studies. The clinical relevance of the present findings is that there is no need to avoid coffee as the drink choice for healthy people. Conclusions: The findings of this study demonstrate that the consumption of caffeinated and decaffeinated coffee with or without sugar has no acute effects on glucose metabolism in healthy men. Further researches, including long-term interventional studies, are needed to fully elucidate the mechanisms behind the coffee effects on reduced risk for Type 2 Diabetes Mellitus.

Keywords: coffee, diabetes mellitus type 2, glucose, insulin

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26161 Future Considerations for Wounded Service Members and Veterans of the Global War on Terror

Authors: Selina Doncevic, Lisa Perla, Angela Kindvall

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The Global War on Terror which began after September 11, 2011, increased survivability of severe injuries requiring varying trajectories of rehabilitation and recovery. The costs encompass physiologic, functional, social, emotional, psychological, vocational and scholastic domains of life. The purpose of this poster is to inform private sector health care practitioners and clinicians at various levels of the unique and long term dynamics of healthcare recovery for polytrauma, and traumatic brain injured service members and veterans in the United States of America. Challenges include care delivery between the private sector, the department of defense, and veterans affairs healthcare systems while simultaneously supporting the dynamics of acute as well as latent complications associated with severe injury and illness. Clinical relevance, subtleties of protracted recovery, and overwhelmed systems of care are discussed in the context of lessons learned and in reflection on previous wars. Additional concerns for consideration and discussion include: the cost of protracted healthcare, various U.S. healthcare payer systems, lingering community reintegration challenges, ongoing care giver support, the rise of veterans support groups and the development of private sector clinical partnerships.

Keywords: brain injury, future, polytrauma, rehabilitation

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26160 Perceptions of Cognitive Behavioural Therapy in Physiotherapy Management for Chronic Low Back Pain: A Qualitative Exploration of Stakeholder Views

Authors: Latifa Alenezi, Liz Croot, Janet Harris

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Chronic Low Back Pain (CLBP) is one of the most common and recurrent musculoskeletal problems that causes patients to access health care services frequently. The Bio-psychosocial Model emphasises that psychological, behavioural and social factors contribute to the development and persistence of CLBP. Cognitive behavioural therapy (CBT) is a psychological pain management strategy that can be used by physiotherapists treating chronic low back pain. However, evidence of the effectiveness of CBT for CLBP varies between different studies. The proposed study was preceded by a mixed methods systematic review that found that CBT has a beneficial effect for CLBP patients when compared to waiting list or other treatments; however, there is variation in effectiveness across different settings. Little is known about how CBT is applied by physiotherapists in physiotherapy settings. The interest of this study is directed towards generating an explanation and understanding of why, when, and how some physiotherapists make decisions and choose to apply CBT for CLBP patients, whereas others do not. Also, how and for what type of CLBP patients does CBT work, and for whom might CBT not work? Therefore, the study will take a qualitative approach to explore CLBP patients’, physiotherapists’ and managers’ perceptions of CBT and how it is used in physiotherapy to enable a deeper understanding and richer explanation of CBT effectiveness and help to inform research and practice. The study will use grounded theory approach to generate an explanatory theory of the clinical application of CBT for CLBP in physiotherapy settings. Physiotherapists, patients and managers of physiotherapy services will be interviewed. Grounded theory techniques will be used to analyse the data. The presentation will describe findings from the interviews and the emerging theory. This research will help to further inform RCTs about the effectiveness of CBT for CLBP in physiotherapy.

Keywords: CBT, CLBP, perception, physiotherapy, theory

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26159 Patient Progression at Discharge: A Communication, Coordination, and Accountability Gap among Hospital Teams

Authors: Nana Benma Osei

Abstract:

Patient discharge can be a hectic process. Patients are sometimes sent to the wrong location or forgotten in lounges in the waiting room. This ends up compromising patient care because the delay in picking the patients can affect how they adhere to medication. Patients may fail to take their medication, and this will lead to negative outcomes. The situation highlights the demands of modern-day healthcare, and the use of technology can help in reducing such challenges and in enhancing the patient’s experience, leading to greater satisfaction with the care provided. The paper contains the proposed changes to a healthcare facility by introducing the clinical decision support system, which will be needed to improve coordination and communication during patient discharge. This will be done under Kurt Lewin’s Change Management Model, which recognizes the different phases in the change process. A pilot program is proposed initially before the program can be implemented in the entire organization. This allows for the identification of challenges and ways of managing them. The paper anticipates some of the possible challenges that may arise during implementation, and a multi-disciplinary approach is considered the most effective. Opposition to the change is likely to arise because staff members may lack information on how the changes will affect them and the skills they will need to learn to use the new system. Training will occur before the technology can be implemented. Every member will go for training, and adequate time is allocated for training purposes. A comparison of data will determine whether the project has succeeded.

Keywords: patient discharge, clinical decision support system, communication, collaboration

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26158 Epidemiological, Clinical and Bacteriological Profile of Human Brucellosis in the District of Tunis

Authors: Jihene Bettaieb, Ghassen kharroubi, Rym mallekh, Ines Cherif, Taoufik Atawa, Kaouther Harrabech

Abstract:

Brucellosis is a major worldwide zoonosis. It is a reportable condition in Tunisia where the disease remains endemic, especially in rural areas. The aim of this study was to describe the epidemiological, clinical, and bacteriological profile of human brucellosis cases notified in the district of Tunis. It was a retrospective descriptive study of cases reported in the district of Tunis through the national surveillance system between the 1st January and 31th December 2017. During the study period, 133 brucellosis confirmed cases were notified. The mean age was 37.5 ± 18.0 years, and 54.9% of cases were males. More than four-fifths (82.7%) of cases were reported in spring and summer with a peak in the month of May (36 cases). Fever and sweats were the most common symptoms; they occurred in 95% and 72% of cases, respectively. Osteoarticular complications occurred in 10 cases, meningitis in one case and endocarditis in one other case. Wright agglutination test and Rose Bengale test were positive in 100% and 91% of cases, respectively. While blood culture was positive in 9 cases and PCR in 2 cases. Brucella melitensis was the only identified specie (9 cases). Almost all cases (99.2%) reported the habit of consuming raw dairy products. Only 5 cases had a suspect contact with animals; among them, 3 persons were livestock breeders. The transmission was essentially due to raw dairy product consumption. It is important to enhance preventive measures to control animal Brucellosis and to educate the population regarding the risk factors of the disease.

Keywords: brucellosis, risk factors, surveillance system, Tunisia

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26157 The Multidisciplinary Treatment in Residence Care Clinic for Treatment of Feeding and Eating Disorders

Authors: Yuri Melis, Mattia Resteghini, Emanuela Apicella, Eugenia Dozio, Leonardo Mendolicchio

Abstract:

Aim: This retrospective study was created to analyze the psychometric, anthropometric and body composition values in patients at the beginning and the discharge of their of hospitalization in the residential care clinic for eating and feeding disorders (EFD’s). Method: The sample was composed by (N=59) patients with mean age N= 33,50, divided in subgroups: Anorexia Nervosa (AN) (N=28), Bulimia Nervosa (BN) (N=13) and Binge Eating Disorders (BED) (N=14) recruited from a residential care clinic for eating and feeding disorders. The psychometrics level was measured with self-report questionnaires: Eating Disorders Inventory-3 (EDI-3) The Body Uneasiness Test (BUT), Minnesota Multiphasic Personality Inventory (MMPI – 2). The anthropometric and nutritional values was collected by Body Impedance Assessment (B.I.A), Body mass index (B.M.I.). Measurements were made at the beginning and at the end of hospitalization, with an average time of recovery of about 8,6 months. Results: The all data analysis showed a statistical significance (p-value >0,05 | power size N=0,950) in variation from T0 (start of recovery) to T1 (end of recovery) in the clinical scales of MMPI-2, AN group (Hypocondria T0 64,14 – T1 56,39) (Depression T0 72,93 – T1 59,50) (Hysteria T0 61,29 – T1 56,17) (Psychopathic deviation T0 64,00 – T1 60,82) (Paranoia T0 63,82 – T1 56,14) (Psychasthenia T0 63,82 – T1 57,86) (Schizophrenia T0 64,68 – T1 60,43) (Obsessive T0 60,36 – T1 55,68); BN group (Hypocondria T0 64,08 – T1 47,54) (Depression T0 67,46 – T1 52,46) (Hysteria T0 60,62 – T1 47,84) (Psychopathic deviation T0 65,69 – T1 58,92) (Paranoia T0 67,46 – T1 55,23) (Psychasthenia T0 60,77 – T1 53,77) (Schizophrenia T0 64,68 – T1 60,43) (Obsessive T0 62,92 – T1 54,08); B.E.D groups (Hypocondria T0 59,43 – T1 53,14) (Depression T0 66,71 – T1 54,57) (Hysteria T0 59,86 – T1 53,82) (Psychopathic deviation T0 67,39 – T1 59,03) (Paranoia T0 58,57 – T1 53,21) (Psychasthenia T0 61,43 – T1 53,00) (Schizophrenia T0 62,29 – T1 56,36) (Obsessive T0 58,57 – T1 48,64). EDI-3 report mean value is higher than clinical cut-off at T0, in T1, there is a significant reduction of the general mean of value. The same result is present in the B.U.T. test in the difference between T0 to T1. B.M.I mean value in AN group is (T0 14,83 – T1 18,41) BN group (T0 20 – T1 21,33) BED group (T0 42,32 – T1 34,97) Phase Angle results: AN group (T0 4,78 – T1 5,64) BN (T0 6 – T1 6,53) BED group (T0 6 – T1 6,72). Discussion and conclusion: The evident presence that on the whole sample, we have an altered serious psychiatric and clinic conditions at the beginning of recovery. The interesting conclusions that we can draw from this analysis are that a multidisciplinary approach that includes the entire care of the subject: from the pharmacological treatment, analytical psychotherapy, Psychomotricity, nutritional rehabilitation, and rehabilitative, educational activities. Thus, this Multidisciplinary treatment allows subjects in our sample to be able to restore psychopathological and metabolic values to below the clinical cut-off.

Keywords: feeding and eating disorders, anorexia nervosa, care clinic treatment, multidisciplinary treatment

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26156 Postmortem Magnetic Resonance Imaging as an Objective Method for the Differential Diagnosis of a Stillborn and a Neonatal Death

Authors: Uliana N. Tumanova, Sergey M. Voevodin, Veronica A. Sinitsyna, Alexandr I. Shchegolev

Abstract:

An important part of forensic and autopsy research in perinatology is the answer to the question of life and stillbirth. Postmortem magnetic resonance imaging (MRI) is an objective non-invasive research method that allows to store data for a long time and not to exhume the body to clarify the diagnosis. The purpose of the research is to study the possibilities of a postmortem MRI to determine the stillbirth and death of a newborn who had spontaneous breathing and died on the first day after birth. MRI and morphological data of a study of 23 stillborn bodies, prenatally dead at a gestational age of 22-39 weeks (Group I) and the bodies of 16 newborns who died from 2 to 24 hours after birth (Group II) were compared. Before the autopsy, postmortem MRI was performed on the Siemens Magnetom Verio 3T device in the supine position of the body. The control group for MRI studies consisted of 7 live newborns without lung disease (Group III). On T2WI in the sagittal projection was measured MR-signal intensity (SI) in the lung tissue (L) and shoulder muscle (M). During the autopsy, a pulmonary swimming test was evaluated, and macro- and microscopic studies were performed. According to the postmortem MRI, the highest values of mean SI of the lung (430 ± 27.99) and of the muscle (405.5 ± 38.62) on T2WI were detected in group I and exceeded the corresponding value of group II by 2.7 times. The lowest values were found in the control group - 77.9 ± 12.34 and 119.7 ± 6.3, respectively. In the group II, the lung SI was 1.6 times higher than the muscle SI, whereas in the group I and in the control group, the muscle SI was 2.1 times and 1.8 times larger than the lung. On the basis of clinical and morphological data, we calculated the formula for determining the breathing index (BI) during postmortem MRI: BI = SIL x SIM / 100. The mean value of BI in the group I (1801.14 ± 241.6) (values ranged from 756 to 3744) significantly higher than the corresponding average value of BI in the group II (455.89 ± 137.32, p < 0.05) (305-638.4). In the control group, the mean BI value was 91.75 ± 13.3 (values ranged from 53 to 154). The BI with the results of pulmonary swimming tests and microscopic examination of the lungs were compared. The boundary value of BI for the differential diagnosis of stillborn and newborn death was 700. Using the postmortem MRI allows to differentiate the stillborn with the death of the breathing newborn.

Keywords: lung, newborn, postmortem MRI, stillborn

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26155 Breast Cancer Cellular Immunotherapies

Authors: Zahra Shokrolahi, Mohammad Reza Atashzar

Abstract:

The goals of treating patients with breast cancer are to cure the disease, prolong survival, and improve quality of life. Immune cells in the tumor microenvironment have an important role in regulating tumor progression. The term of cellular immunotherapy refers to the administration of living cells to a patient; this type of immunotherapy can be active, such as a dendritic cell (DC) vaccine, in that the cells can stimulate an anti-tumour response in the patient, or the therapy can be passive, whereby the cells have intrinsic anti-tumour activity; this is known as adoptive cell transfer (ACT) and includes the use of autologous or allogeneic lymphocytes that may, or may not, be modified. The most important breast cancer cellular immunotherapies involving the use of T cells and natural killer (NK) cells in adoptive cell transfer, as well as dendritic cells vaccines. T cell-based therapies including tumour-infiltrating lymphocytes (TILs), engineered TCR-T cells, chimeric antigen receptor (CAR T cell), Gamma-delta (γδ) T cells, natural killer T (NKT) cells. NK cell-based therapies including lymphokine-activated killers (LAK), cytokine-induced killer (CIK) cells, CAR-NK cells. Adoptive cell therapy has some advantages and disadvantages some. TILs cell strictly directed against tumor-specific antigens but are inactive against tumor changes due to immunoediting. CIK cell have MHC-independent cytotoxic effect and also need concurrent high dose IL-2 administration. CAR T cell are MHC-independent; overcome tumor MHC molecule downregulation; potent in recognizing any cell surface antigen (protein, carbohydrate or glycolipid); applicable to a broad range of patients and T cell populations; production of large numbers of tumor-specific cells in a moderately short period of time. Meanwhile CAR T cells capable of targeting only cell surface antigens; lethal toxicity due to cytokine storm reported. Here we present the most popular cancer cellular immunotherapy approaches and discuss their clinical relevance referring to data acquired from clinical trials .To date, clinical experience and efficacy suggest that combining more than one immunotherapy interventions, in conjunction with other treatment options like chemotherapy, radiotherapy and targeted or epigenetic therapy, should guide the way to cancer cure.

Keywords: breast cancer , cell therapy , CAR T cell , CIK cells

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26154 A Socio-political Analysis of Mindfulness Practice in Hong Kong

Authors: Pinqiao Wang

Abstract:

Mindfulness, derived from Buddhism, has been developed to improve individuals' well-being, first in the West and then gaining growing popularity in Asia. Numerous research studies have proven the effectiveness of mindfulness among clinical groups and the public all over the world. However, as enthusiasm surges, reflections on mindfulness and its commodification and instrumentalization arise. Hong Kong was seen as the model of a free market by neoliberal economists. The relationships between its socioeconomic neoliberalism, Western-inspired democracy aspiration, and political harmonization with China Mainland have been fraught with tensions, which have been further exacerbated by socio-political changes since the 2010s. Under such circumstances, mental health problems have come into the spotlight in Hong Kong recently. Mindfulness has gained growing popularity in Hong Kong, with its influence reaching from primary schools to corporate settings. A more comprehensive socio-political analysis of mindfulness within the Hong Kong context warrants further exploration. Drawing on interview responses from mindfulness practitioners, we examine the connections between the ideologies underlying mindfulness and contemporary capitalist society. On the one hand, mindfulness focuses on the present moment and self-improvement, representing neoliberal capitalist spirituality and reinforcing existing power relations. On the other hand, mindfulness fosters the acceptance of difference, which is argued to demonstrate the potential for advancing democracy at both the individual and community levels. Academically, this research provides empirical evidence to advance the current discussions and debates surrounding the socio-political potential of mindfulness. Practically, it serves as a reflection on mindfulness practices to optimize their impact on individuals and society.

Keywords: neoliberal subjectivity, qualitative analysis, social construction, technologies of the self, therapeutic culture

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26153 Lennox-gastaut Syndrome Associated with Dysgenesis of Corpus Callosum

Authors: A. Bruce Janati, Muhammad Umair Khan, Naif Alghassab, Ibrahim Alzeir, Assem Mahmoud, M. Sammour

Abstract:

Rationale: Lennox-Gastaut syndrome(LGS) is an electro-clinical syndrome composed of the triad of mental retardation, multiple seizure types, and the characteristic generalized slow spike-wave complexes in the EEG. In this article, we report on two patients with LGS whose brain MRI showed dysgenesis of corpus callosum(CC). We review the literature and stress the role of CC in the genesis of secondary bilateral synchrony(SBS). Method: This was a clinical study conducted at King Khalid Hospital. Results: The EEG was consistent with LGS in patient 1 and unilateral slow spike-wave complexes in patient 2. The MRI showed hypoplasia of the splenium of CC in patient 1, and global hypoplasia of CC combined with Joubert syndrome in patient 2. Conclusion: Based on the data, we proffer the following hypotheses: 1-Hypoplasia of CC interferes with functional integrity of this structure. 2-The genu of CC plays a pivotal role in the genesis of secondary bilateral synchrony. 3-Electrodecremental seizures in LGS emanate from pacemakers generated in the brain stem, in particular the mesencephalon projecting abnormal signals to the cortex via thalamic nuclei. 4-Unilateral slow spike-wave complexes in the context of mental retardation and multiple seizure types may represent a variant of LGS, justifying neuroimaging studies.

Keywords: EEG, Lennox-Gastaut syndrome, corpus callosum , MRI

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26152 Application of Metric Dimension of Graph in Unraveling the Complexity of Hyperacusis

Authors: Hassan Ibrahim

Abstract:

The prevalence of hyperacusis, an auditory condition characterized by heightened sensitivity to sounds, continues to rise, posing challenges for effective diagnosis and intervention. It is believed that this work deepens will deepens the understanding of hyperacusis etiology by employing graph theory as a novel analytical framework. We constructed a comprehensive graph wherein nodes represent various factors associated with hyperacusis, including aging, head or neck trauma, infection/virus, depression, migraines, ear infection, anxiety, and other potential contributors. Relationships between factors are modeled as edges, allowing us to visualize and quantify the interactions within the etiological landscape of hyperacusis. it employ the concept of the metric dimension of a connected graph to identify key nodes (landmarks) that serve as critical influencers in the interconnected web of hyperacusis causes. This approach offers a unique perspective on the relative importance and centrality of different factors, shedding light on the complex interplay between physiological, psychological, and environmental determinants. Visualization techniques were also employed to enhance the interpretation and facilitate the identification of the central nodes. This research contributes to the growing body of knowledge surrounding hyperacusis by offering a network-centric perspective on its multifaceted causes. The outcomes hold the potential to inform clinical practices, guiding healthcare professionals in prioritizing interventions and personalized treatment plans based on the identified landmarks within the etiological network. Through the integration of graph theory into hyperacusis research, the complexity of this auditory condition was unraveled and pave the way for more effective approaches to its management.

Keywords: auditory condition, connected graph, hyperacusis, metric dimension

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26151 Critical Review Whether Restricting Dietary Saturated Fat Can Reduce the Risk of Cardiovascular Disease

Authors: Obi Olor, Asu-Nnandi Judith, Ishiekwen Bridget

Abstract:

Regardless of the settled perception that the substitution of saturated fats for starches or unsaturated fats builds low-density lipoprotein (LDL) cholesterol in people, in animal models, the relationship of saturated fat intake to the hazard of atherosclerotic cardiovascular ailment in people remains controversial. Clinical trials that supplanted immersed fat with polyunsaturated fat have, for the most part, demonstrated a lessening in CVD occasions, albeit a few reviews demonstrated no impacts. An autonomous relationship of soaked fat admission with CVD chance has not reliably appeared in planned epidemiologic reviews, albeit some have confirmed an expanded hazard in youthful people and in ladies. Substitution of soaked fat by polyunsaturated or monounsaturated fat reduces LDL and HDL cholesterol. Given the differing qualities of these cardio-protective eating methodologies and their healthy parts, one of the needs in research should be to attempt more near trials. These trials decide persistent worthiness, consequences for surrogate markers of hazard, and which at last affects morbidity and mortality.

Keywords: cardiovascular disease, dietary saturated fat, saturated fat, unsaturated fat

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26150 Analysis of Trends in Environmental Health Research Using Topic Modeling

Authors: Hayoung Cho, Gabi Cho

Abstract:

In response to the continuing increase of demands for living environment safety, the Korean government has established and implemented various environmental health policies and set a high priority to the related R&D. However, the level of related technologies such as environmental risk assessment are still relatively low, and there is a need for detailed investment strategies in the field of environmental health research. As scientific research papers can give valuable implications on the development of a certain field, this study analyzed the global research trends in the field of environmental health over the past 10 years (2005~2015). Research topics were extracted from abstracts of the collected SCI papers using topic modeling to study the changes in research trends and discover emerging technologies. The method of topic modeling can improve the traditional bibliometric approach and provide a more comprehensive review of the global research development. The results of this study are expected to help provide insights for effective policy making and R&D investment direction.

Keywords: environmental health, paper analysis, research trends, topic modeling

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26149 Suggestions to the Legislation about Medical Ethics and Ethics Review in the Age of Medical Artificial Intelligence

Authors: Xiaoyu Sun

Abstract:

In recent years, the rapid development of Artificial Intelligence (AI) has extensively promoted medicine, pharmaceutical, and other related fields. The medical research and development of artificial intelligence by scientific and commercial organizations are on the fast track. The ethics review is one of the critical procedures of registration to get the products approved and launched. However, the SOPs for ethics review is not enough to guide the healthy and rapid development of artificial intelligence in healthcare in China. Ethical Review Measures for Biomedical Research Involving Human Beings was enacted by the National Health Commission of the People's Republic of China (NHC) on December 1st, 2016. However, from a legislative design perspective, it was neither updated timely nor in line with the trends of AI international development. Therefore, it was great that NHC published a consultation paper on the updated version on March 16th, 2021. Based on the most updated laws and regulations in the States and EU, and in-depth-interviewed 11 subject matter experts in China, including lawmakers, regulators, and key members of ethics review committees, heads of Regulatory Affairs in SaMD industry, and data scientists, several suggestions were proposed on top of the updated version. Although the new version indicated that the Ethics Review Committees need to be created by National, Provincial and individual institute levels, the review authorities of different levels were not clarified. The suggestion is that the precise scope of review authorities for each level should be identified based on Risk Analysis and Management Model, such as the complicated leading technology, gene editing, should be reviewed by National Ethics Review Committees, it will be the job of individual institute Ethics Review Committees to review and approve the clinical study with less risk such as an innovative cream to treat acne. Furthermore, to standardize the research and development of artificial intelligence in healthcare in the age of AI, more clear guidance should be given to data security in the layers of data, algorithm, and application in the process of ethics review. In addition, transparency and responsibility, as two of six principles in the Rome Call for AI Ethics, could be further strengthened in the updated version. It is the shared goal among all countries to manage well and develop AI to benefit human beings. Learned from the other countries who have more learning and experience, China could be one of the most advanced countries in artificial intelligence in healthcare.

Keywords: biomedical research involving human beings, data security, ethics committees, ethical review, medical artificial intelligence

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26148 Assessing the Efficiency of Pre-Hospital Scoring System with Conventional Coagulation Tests Based Definition of Acute Traumatic Coagulopathy

Authors: Venencia Albert, Arulselvi Subramanian, Hara Prasad Pati, Asok K. Mukhophadhyay

Abstract:

Acute traumatic coagulopathy in an endogenous dysregulation of the intrinsic coagulation system in response to the injury, associated with three-fold risk of poor outcome, and is more amenable to corrective interventions, subsequent to early identification and management. Multiple definitions for stratification of the patients' risk for early acute coagulopathy have been proposed, with considerable variations in the defining criteria, including several trauma-scoring systems based on prehospital data. We aimed to develop a clinically relevant definition for acute coagulopathy of trauma based on conventional coagulation assays and to assess its efficacy in comparison to recently established prehospital prediction models. Methodology: Retrospective data of all trauma patients (n = 490) presented to our level I trauma center, in 2014, was extracted. Receiver operating characteristic curve analysis was done to establish cut-offs for conventional coagulation assays for identification of patients with acute traumatic coagulopathy was done. Prospectively data of (n = 100) adult trauma patients was collected and cohort was stratified by the established definition and classified as "coagulopathic" or "non-coagulopathic" and correlated with the Prediction of acute coagulopathy of trauma score and Trauma-Induced Coagulopathy Clinical Score for identifying trauma coagulopathy and subsequent risk for mortality. Results: Data of 490 trauma patients (average age 31.85±9.04; 86.7% males) was extracted. 53.3% had head injury, 26.6% had fractures, 7.5% had chest and abdominal injury. Acute traumatic coagulopathy was defined as international normalized ratio ≥ 1.19; prothrombin time ≥ 15.5 s; activated partial thromboplastin time ≥ 29 s. Of the 100 adult trauma patients (average age 36.5±14.2; 94% males), 63% had early coagulopathy based on our conventional coagulation assay definition. Overall prediction of acute coagulopathy of trauma score was 118.7±58.5 and trauma-induced coagulopathy clinical score was 3(0-8). Both the scores were higher in coagulopathic than non-coagulopathic patients (prediction of acute coagulopathy of trauma score 123.2±8.3 vs. 110.9±6.8, p-value = 0.31; trauma-induced coagulopathy clinical score 4(3-8) vs. 3(0-8), p-value = 0.89), but not statistically significant. Overall mortality was 41%. Mortality rate was significantly higher in coagulopathic than non-coagulopathic patients (75.5% vs. 54.2%, p-value = 0.04). High prediction of acute coagulopathy of trauma score also significantly associated with mortality (134.2±9.95 vs. 107.8±6.82, p-value = 0.02), whereas trauma-induced coagulopathy clinical score did not vary be survivors and non-survivors. Conclusion: Early coagulopathy was seen in 63% of trauma patients, which was significantly associated with mortality. Acute traumatic coagulopathy defined by conventional coagulation assays (international normalized ratio ≥ 1.19; prothrombin time ≥ 15.5 s; activated partial thromboplastin time ≥ 29 s) demonstrated good ability to identify coagulopathy and subsequent mortality, in comparison to the prehospital parameter-based scoring systems. Prediction of acute coagulopathy of trauma score may be more suited for predicting mortality rather than early coagulopathy. In emergency trauma situations, where immediate corrective measures need to be taken, complex multivariable scoring algorithms may cause delay, whereas coagulation parameters and conventional coagulation tests will give highly specific results.

Keywords: trauma, coagulopathy, prediction, model

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26147 The Relationship between First-Day Body Temperature and Mortality in Traumatic Patients

Authors: Neda Valizadeh, Mani Mofidi, Sama Haghighi, Ali Hashemaghaee, Soudabeh Shafiee Ardestani

Abstract:

Background: There are many systems and parameters to evaluate trauma patients in the emergency department. Most of these evaluations are to distinguish patients with worse conditions so that the care systems have a better prediction of condition for a better care-giving. The purpose of this study is to determine the relationship between axillary body temperature and mortality in patients hospitalized in the intensive care unit (ICU) with multiple traumas and with other clinical and para-clinical factors. Methods: All patients between 16 and 75 years old with multiple traumas who were admitted into Emergency Department then hospitalized in the ICU were included in our study. An axillary temperature in the first and the second day of admission, Glasgow cola scale (GCS), systolic blood pressure, Serum glucose levels, and white blood cell counts of all patients at the admission day were recorded and their relationship with mortality were analyzed by SPSS software with suitable statistical tests. Results: Axillary body temperatures in the first and second day were statistically lower in expired traumatic patients (p=0.001 and p<0,001 respectively). Patients with lower GCS had a significantly lower first-day temperature and a significantly higher mortality. (p=0.006 and p=0.006 respectively). Furthermore, the first-day axillary temperature was significantly lower in patients with a lower first-day systolic blood pressure (p=0.014). Conclusion: Our results showed that lower axillary body temperature in the first day is associated with higher mortality, lower GCS, and lower systolic blood pressure. Thus, this could be used as a predictor of mortality in evaluation of traumatic patients in emergency settings.

Keywords: fever, trauma, mortality, emergency

Procedia PDF Downloads 372