Search results for: clinical reasoning

Authors: J. Visser, C. Driver, T. Ebenhan

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[¹⁸F]-FDG (fluorodeoxyglucose) is a radiopharmaceutical compound that is used for non-invasive cancer tumor imaging through positron emission tomography (PET). This radiopharmaceutical is used to visualise the metabolic processes in tumour tissues, which can be applied for the diagnosis and prognosis of various types of cancer. [¹⁸F]-FDG has widespread use in both clinical and pre-clinical research settings. Imaging using [¹⁸F]-FDG results in representative normal tissue distribution as well as visualisation of hypermetabolic lesions ([¹⁸F]-FDG avid foci). The metabolic tissue concentration of these lesions following [¹⁸F]-FDG administration can be quantified using Standard Uptake Values (SUV). Standard uptake values of [¹⁸F]-FDG-based Positron Emission Tomography can be influenced by various biological and technical handling factors. Biological factors that affect [¹⁸F]-FDG uptake include the blood glucose levels of subjects, normal physiological variants between subjects and administration of certain pharmaceutical agents. Technical factors that can have an effect include the route of radiopharmaceutical or pharmaceutical agents administered and environmental conditions such as ambient temperature and lighting. These factors influencing tracer uptake need to be investigated to improve the robustness of the imaging protocol, which will achieve reproducible image acquisition across various research projects, optimised tumor visualisation and increased data validity and reliability.

Keywords: fluorodeoxyglucose, tumour imaging, Rodent, Blood Glucose, PET/CT Imaging

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Authors: Cornelia-Eugenia Munteanu

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The goal of this paper is to present the diagnostic contribution that the screening instrument, Mini-Mental State Examination-2: Expanded Version (MMSE-2:EV), brings in detecting the cognitive impairment or in monitoring the progress of degenerative disorders. The diagnostic signification is underlined by the interpretation of the MMSE-2:EV scores, resulted from the test application to patients with mild and major neurocognitive disorders. The original MMSE is one of the most widely used screening tools for detecting the cognitive impairment, in clinical settings, but also in the field of neurocognitive research. Now, the practitioners and researchers are turning their attention to the MMSE-2. To enhance its clinical utility, the new instrument was enriched and reorganized in three versions (MMSE-2:BV, MMSE-2:SV and MMSE-2:EV), each with two forms: blue and red. The MMSE-2 was adapted and used successfully in Romania since 2013. The cases were selected from current practice, in order to cover vast and significant neurocognitive pathology: mild cognitive impairment, Alzheimer’s disease, vascular dementia, mixed dementia, Parkinson’s disease, conversion of the mild cognitive impairment into Alzheimer’s disease. The MMSE-2:EV version was used: it was applied one month after the initial assessment, three months after the first reevaluation and then every six months, alternating the blue and red forms. Correlated with age and educational level, the raw scores were converted in T scores and then, with the mean and the standard deviation, the z scores were calculated. The differences of raw scores between the evaluations were analyzed from the point of view of statistic signification, in order to establish the progression in time of the disease. The results indicated that the psycho-diagnostic approach for the evaluation of the cognitive impairment with MMSE-2:EV is safe and the application interval is optimal. The alternation of the forms prevents the learning phenomenon. The diagnostic accuracy and efficient therapeutic conduct derive from the usage of the national test norms. In clinical settings with a large flux of patients, the application of the MMSE-2:EV is a safe and fast psycho-diagnostic solution. The clinicians can draw objective decisions and for the patients: it doesn’t take too much time and energy, it doesn’t bother them and it doesn’t force them to travel frequently.

Keywords: MMSE-2, dementia, cognitive impairment, neuropsychology

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Authors: Jakub Młoźniak, Adam Szymański, Gabriela Stondzik, Dagny Krankowska, Tomasz Mikuła

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Nontuberculous mycobacteria (NTM) are bacterial species that cause diversely manifesting diseases mainly in immunocompromised patients. In people with HIV, NTM infection is an AIDS-defining disease and usually appears when the lymphocyte T CD4 count is below 50 cells/μl. The usage of antiretroviral therapy has decreased the prevalence of NTM among people with HIV, but the disease can still be observed especially among patients with late HIV diagnosis. Common presence in environment, human colonization, clinical similarity with tuberculosis and slow growth on culture makes NTM especially hard to diagnose. The study aimed to analyze the epidemiology and clinical course of NTM among patients with HIV. This study included patients with NTM and HIV admitted to our department between 2017 and 2023. Medical records of patients were analyzed and data on age, sex, median time from HIV diagnosis to identification of NTM infection, median CD4 count at NTM diagnosis, methods of determining NTM infection, type of species of mycobacteria identified, clinical symptoms and treatment course were gathered. Twenty-four patients (20 men, 4 women) with identified NTM were included in this study. Among them, 20 were HIV late presenters. The patients' median age was 40. The main symptoms which patients presented were fever, weight loss and cough. Pulmonary disease confirmed with positive cultures from sputum/bronchoalveolar lavage was present in 18 patients. M. avium was the most common species identified. M. marinum caused disseminated skin lesions in 1 patient. Out of all, 5 people were not treated for NTM caused by lack of symptoms and suspicion of colonization with mycobacterium. Concomitant tuberculosis was present in 6 patients. The median diagnostic time from HIV to NTM infections was 3.5 months. The median CD4 count at NTM identification was 69.5 cells/μl. Median NTM treatment time was 16 months but 7 patients haven’t finished their treatment yet. The most commonly used medications were ethambutol and clarithromycin. Among analyzed patients, 4 of them have died. NTM infections are still an important disease among patients who are HIV late presenters. This disease should be taken into consideration during the differential diagnosis of fever, weight loss and cough in people with HIV with lymphocyte T CD4 count <100 cells/μl. Presence of tuberculosis does not exclude nontuberculous mycobacterium coinfection.

Keywords: mycobacteriosis, HIV, late presenter, epidemiology

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Authors: Dagim Ali Hussen, Adnan A. Bekhit, Ariaya Hymete

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In this study, several pyridine derivatives were synthesized and evaluated for their in vitro antimicrobial activity against gram-positive bacteria (S. aureus and B. Cereus), gram-negative bacteria (P. aeruginosa and E. coli) and fungus (C. albican and A niger). The intermediate chalcone derivative 2a,b was synthesized by condensation of pyrazole aldehydes 1a,b with acetophenone in alcoholic KOH. Cyclization of 2a,b with ethyl cyanoacetate ad ammonium acetate resulted in pyridine carbonitrile derivatives 3a,b. Furthermore, condensation of pyridine-4-carboxaldeyhe with different amino-derivatives gave rise to pyridine derivatives 5a,b, 6a,b. The oxadiazole derivative 7a was prepared by cyclization of 6a with acetic anhydride. Characterization of the synthesized compound was performed using IR, 1H NMR, 13C NMR spectra and elemental microanalyses. The antimicrobial results revealed that compounds 5a, 6b and 7a exhibited half fold antibacterial activity compared to ampicillin, against B. cereus. On the other hand, compound 3b showed an equivalent activity compared to miconazole against candida albican (CANDAL 03) and to clotrimazole against the clinical isolate candida albican 6647. Moreover, this compound 3b was further tested for its acute toxicity profile. The results showed that oral LD50 is more that 300 mg/kg and parentral LD50 is more than 100 mg/kg. Compound 3b is a good candidate for antifungal agent with good toxicity profile, and deserves more chemical derivatization and clinical study.

Keywords: antifungal, antimicrobial, Candida albican, pyridine

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Authors: Davit Khachatryan, Shuo Xiang

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Numerous published studies on the use of prazosin in the treatment of PTSD-related sleep disturbances in adult population have resulted in updates to the recommendation for prazosin for nightmares that showed its strength of evidence elevated from C to B in the US Department of Veterans Affairs clinical practice guideline. In addition, the American Academy of Sleep Medicine clinical practice guideline gave prazosin a level-A recommendation for the treatment of PTSD-associated nightmares. The aim of this review is to summarize the available literature for prazosin use for nightmares and other sleep disturbances in children and adolescents with PTSD. Method: A comprehensive search for studies on prazosin use for sleep disturbances in child and adolescent population with PTSD has been performed. We looked at MEDLINE, EMBASE, PsycINFO, CINAHL, AMED, Scopus, Web of Science, and Cochrane CENTRAL databases. Results: Compared to adult population with similar psychopathology, the available literature in child and adolescent population is scarce. Despite increased interest in prazosin in the management of PTSD, only six studies investigating this medication in children and adolescents have been published. Conclusion: A large randomized control trial on this topic is needed for more definite evidence on the efficacy and safety of prazosin in the treatment of nightmares in children and adolescents with PTSD.

Keywords: guidelines, prazosin, PTSD, sleep disturbance

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Authors: Thao Nguyen, Maximiliano Hyon, Sany Rajagukguk, Anna Melkonyan

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Introduction: Type 2 Diabetes is a well-established risk factor for severe SARS-CoV-2 infection. Uncontrolled hyperglycemia in patients with established or newly diagnosed diabetes is associated with poor outcomes, including increased mortality and hospital length of stay. Objectives: Our study aims to compare three different glycemic management strategies and their association with clinical outcomes in patients hospitalized for moderate to severe SARS-CoV-2 infection. Identifying optimal glycemic management strategies will improve the quality of patient care and improve their outcomes. Method: This is a retrospective observational study on patients hospitalized at Adventist Health White Memorial with severe SARS-CoV-2 infection from 11/1/2020 to 02/28/2021. The following inclusion criteria were used: positive SARS-CoV-2 PCR test, age >18 yrs old, diabetes or random glucose >200 mg/dL on admission, oxygen requirement >4L/min, and treatment with glucocorticoids. Our exclusion criteria included: ICU admission within 24 hours, discharge within five days, death within five days, and pregnancy. The patients were divided into three glycemic management groups: Group 1, managed solely by the Primary Team, Group 2, by Pharmacy; and Group 3, by Endocrinologist. Primary outcomes were average glucose on Day 5, change in glucose between Days 3 and 5, and average insulin dose on Day 5 among groups. Secondary outcomes would be upgraded to ICU, inpatient mortality, and hospital length of stay. For statistics, we used IBM® SPSS, version 28, 2022. Results: Most studied patients were Hispanic, older than 60, and obese (BMI >30). It was the first CV-19 surge with the Delta variant in an unvaccinated population. Mortality was markedly high (> 40%) with longer LOS (> 13 days) and a high ICU transfer rate (18%). Most patients had markedly elevated inflammatory markers (CRP, Ferritin, and D-Dimer). These, in combination with glucocorticoids, resulted in severe hyperglycemia that was difficult to control. Average glucose on Day 5 was not significantly different between groups primary vs. pharmacy vs. endocrine (220.5 ± 63.4 vs. 240.9 ± 71.1 vs. 208.6 ± 61.7 ; P = 0.105). Change in glucose from days 3 to 5 was not significantly different between groups but trended towards favoring the endocrinologist group (-26.6±73.6 vs. 3.8±69.5 vs. -32.2±84.1; P= 0.052). TDD insulin was not significantly different between groups but trended towards higher TDD for the endocrinologist group (34.6 ± 26.1 vs. 35.2 ± 26.4 vs. 50.5 ± 50.9; P=0.054). The endocrinologist group used significantly more preprandial insulin compared to other groups (91.7% vs. 39.1% vs. 65.9% ; P < 0.001). The pharmacy used more basal insulin than other groups (95.1% vs. 79.5% vs. 79.2; P = 0.047). There were no differences among groups in the clinical outcomes: LOS, ICU upgrade, or mortality. Multivariate regression analysis controlled for age, sex, BMI, HbA1c level, renal function, liver function, CRP, d-dimer, and ferritin showed no difference in outcomes among groups. Conclusion: Given high-risk factors in our population, despite efforts from the glycemic management teams, it’s unsurprising no differences in clinical outcomes in mortality and length of stay.

Keywords: glycemic management, strategies, hospitalized, SARS-CoV-2, outcomes

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Authors: Rachel Byrne

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Background: Due to patient and student safety concerns, combined with clinical teachers being redeployed to clinical practice, COVID-19 has resulted in a reduction in face-to-face teaching sessions for medical students. Traditionally such sessions are particularly important for final year medical students, especially in preparing for their final practical exams. A reduced student presence on the wards has also resulted in fewer opportunities for junior doctors to provide teaching sessions. This has implications for junior doctors achieving their own curriculum outcomes for teaching, as well as potentially hindering the development of a future interest in medical education. Aims: The aims of the study are 1) To create a safe face-to-face teaching environment during COVID-19 which focussed on exam preparation for final year medical students, 2) To provide a platform for doctors to gain teaching experience, 3 ) to enable doctors to gain feedback or assessments on their teaching, 4) To create beginners guide to designing a new teaching program for future junior doctors. Methods: We created a program of timed clinical stations consisting of four sessions every five weeks during the student’s medicine attachment. Each session could be attended by 6 students and consisted of 6 stations ran by junior doctors, with each station following social distancing and personal protective equipment requirements. Junior doctors were asked to design their own stations. The sessions ran out-of-hours on weekday evenings and were optional for the students. Results: 95/95 students and 20/40 doctors involved in the programme completed feedback. 100% (n=95) of students strongly agreed/agreed that sessions were aimed at an appropriate level and provided constructive feedback. 100% (n=95) of students stated they felt more confident in their abilities and would recommend the session to peers. 90% (n=18) of the teachers strongly agreed/agreed that they felt more confident in their teaching abilities and that the sessions had improved their own medical knowledge. 85% (n=17) of doctors had a teaching assessment completed, and 83% (n=16) said the program had made them consider a career in medical education. The difficulties of creating such a program were highlighted throughout, and a beginner’s guide was created with the hopes of helping future doctors who are interested in teaching address the common obstacles.

Keywords: COVID-19, education, safety, medical

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Authors: Anupam Sibal

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Apollo Quality Program(AQP) was launched across the Apollo Group of Hospitals to address the four patient safety areas; Safety during Clinical Handovers, Medication Safety, Surgical Safety and the six International Patient Safety Goals(IPSGs) of JCI. A measurable, online, quality dashboard covering 20 process and outcome parameters was devised for monthly monitoring. The expected outcomes were also defined and categorized into green, yellow and red ranges. An audit methodology was also devised to check the processes for the measurable dashboard. Documented clinical handovers were introduced for the first time at many locations for in-house patient transfer, nursing-handover, and physician-handover. Prototype forms using the SBAR format were made. Patient-identifiers, read-back for verbal orders, safety of high-alert medications, site marking and time-outs and falls risk-assessment were introduced for all hospitals irrespective of accreditation status. Measurement of Surgical-Site-Infection (SSI) for 30 days postoperatively, was done. All hospitals now tracked the time of administration of antimicrobial prophylaxis before surgery. Situations with high risk of retention of foreign body were delineated and precautionary measures instituted. Audit of medications prescribed in the discharge summaries was made uniform. Formularies, prescription-audits and other means for reduction of medication errors were implemented. There is a marked increase in the compliance to processes and patient safety outcomes. Compliance to read-back for verbal orders rose from 86.83% in April’11 to 96.95% in June’15, to policy for high alert medications from 87.83% to 98.82%, to use of measures to prevent wrong-site, wrong-patient, wrong procedure surgery from 85.75% to 97.66%, to hand-washing from 69.18% to 92.54%, to antimicrobial prophylaxis within one hour before incision from 79.43% to 93.46%. Percentage of patients excluded from SSI calculation due to lack of follow-up for the requisite time frame decreased from 21.25% to 10.25%. The average AQP scores for all Apollo Hospitals improved from 62 in April’11 to 87.7 in Jun’15.

Keywords: clinical handovers, international patient safety goals, medication safety, surgical safety

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Authors: Shizra Waris, Bilal Shoaib, Munib Ahmad

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Background; The using of clinical decision support systems (CDSSs) may recover unceasing disease organization, which requires regular visits to multiple health professionals, treatment monitoring, disease control, and patient behavior modification. The objective of this survey is to determine if these CDSSs improve the processes of unceasing care including diagnosis, treatment, and monitoring of diseases. Though artificial intelligence is not a new idea it has been widely documented as a new technology in computer science. Numerous areas such as education business, medical and developed have made use of artificial intelligence Methods: The survey covers articles extracted from relevant databases. It uses search terms related to information technology and viral hepatitis which are published between 2000 and 2016. Results: Overall, 80% of studies asserted the profit provided by information technology (IT); 75% of learning asserted the benefits concerned with medical domain;25% of studies do not clearly define the added benefits due IT. The CDSS current state requires many improvements to hold up the management of liver diseases such as HCV, liver fibrosis, and cirrhosis. Conclusion: We concluded that the planned model gives earlier and more correct calculation of hepatitis B and it works as promising tool for calculating of custom hepatitis B from the clinical laboratory data.

Keywords: detection, hapataties, observation, disesese

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Authors: Rose Chapman Rodriguez

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Problem: Evidence-based practice (EBP) attributes are significantly associated with EBP implementation science, which improves patient care outcomes. Nurses influence EBP, yet little is known of the specific EBP attributes of pediatric nurses in their clinical sub-specialties. Aim: This study aims to investigate the relationship between nursing academic degree, years of experience, and clinical specialty, with mean survey scores on EBP belief, organizational culture, and implementation scales across all levels of nursing in a Children’s Hospital. Methods: A convenience sample of nurses (n=185) participated in a descriptive, cross-sectional, correlational study in May 2023. The electronic surveys comprised 11 demographic questions and nine survey items from the short-version EBP Beliefs Scale (Cronbach α = 0.81), Organizational Culture and Readiness Scale for System-wide Integration Scale (Cronbach α = 0.87), and EBP Implementation Scale (Cronbach α = 0.89). Findings: EBP belief scores were notably higher in nurses working in neonatology (m=4.33), critical care (m=4.47), and among nurse leaders (m=4.50). There was a statistically significant difference in EBP organizational culture among nurse leaders (m = 3.95, p=0.039) compared to clinical nurses (m = 3.34) and advanced practice nurses (m = 3.34). EBP implementation was favorable in neonatology (m=4.20), acute care (m=4.05), and nurse leaders (m=4.33). No significant difference or correlation was found in EBP belief, organizational culture, or implementation mean scores related to nurses' age, academic nursing degree, or years of experience in our cohort (EBP beliefs (r = -.06, p = .400), organizational readiness (r = .02, p = .770), and implementation scales (r = .01, p = .867). Conclusions: This study identified nurse’s EBP attributes in a Children’s Hospital using key variables studied in EBP social cognitive theory and learning theory. Magnet status, shared governance structure, specialty certification, and nurse leaders play a significant role in favorable EBP culture and implementation. Nurses’ unit level ‘group culture’ may vary depending on the EBP attributes and collaborative efforts of local teams. Opportunities for mentoring were identified, which may continue to enhance EBP implementation science across all nursing roles in our pediatric organization.

Keywords: evidence-based practice, peditrics, nursing roles, implementation

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Authors: E. Vlachopapadopoulou, E. Dikaiakou, E. Anagnostou, I. Panagiotopoulos, E. Kaloumenou, M. Kafetzi, A. Fotinou, S. Michalacos

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Aim: To investigate the relation and impact of Body Mass Index (BMI), Waist Circumference (WC) and Body Fat Weight (BFW) on insulin resistance (MATSUDA INDEX < 2.5) in children and adolescents. Methods: Data from 95 overweight and obese children (47 boys and 48 girls) with mean age 10.7 ± 2.2 years were analyzed. ROC analysis was used to investigate the predictive ability of BMI, WC and BFW for insulin resistance and find the optimal cut-offs. The overall performance of the ROC analysis was quantified by computing area under the curve (AUC). Results: ROC curve analysis indicated that the optimal-cut off of WC for the prediction of insulin resistance was 97 cm with sensitivity equal to 75% and specificity equal to 73.1%. AUC was 0.78 (95% CI: 0.63-0.92, p=0.001). The sensitivity and specificity of obesity for the discrimination of participants with insulin resistance from those without insulin resistance were equal to 58.3% and 75%, respectively (AUC=0.67). BFW had a borderline predictive ability for insulin resistance (AUC=0.58, 95% CI: 0.43-0.74, p=0.101). The predictive ability of WC was equivalent with the correspondence predictive ability of BMI (p=0.891). Obese subjects had 4.2 times greater odds for having insulin resistance (95% CI: 1.71-10.30, p < 0.001), while subjects with WC more than 97 had 8.1 times greater odds for having insulin resistance (95% CI: 2.14-30.86, p=0.002). Conclusion: BMI and WC are important clinical factors that have significant clinical relation with insulin resistance in children and adolescents. The cut off of 97 cm for WC can identify children with greater likelihood for insulin resistance.

Keywords: body fat weight, body mass index, insulin resistance, obese children, waist circumference

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Authors: Melliti Rihab, Zaeid Sonia, Khechine Wiem, Daldoul Amira

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Introduction: Lung cancer is the leading cause of cancer death. Its incidence is increasing, and its prognosis remains pejorative. We present the clinical, pathological, and therapeutic characteristics of bronchopulmonary cancer (BPC) in Tunisia. Methods: Retrospective study including patients followed in the oncology department of the University Hospital of Monastir between April 2014 and December 2021 suffering from lung cancer. Results: These are 117 patients, including 86.3% men and 13.7% women (sex ratio 6.3). The average age was 64 years ± 9 (37-83), with 95.7% being over 50 years old. Patients were smokers in 82% of cases. The clinical signs were dominated by chest pain (27.5%) and dyspnea in 21.1% of cases. In 6 patients, an episode of COVID-19 infection revealed the diagnosis. Half of the patients had a PS between 0 and 1. Small cell lung cancer was present in 18 patients (15.4%). The majority of non small cell lung cancer was of the adenocarcinoma type (68.7%). The diagnosis was late (stage IV) in 62.4% of cases. BPC was metastatic to bone (52%), contralateral lung (25.9%), and brain (27.3%). Patients were oligometastatic in 26% of cases. Surgery and radiotherapy were performed respectively in 14.5% and 23.1% of cases. Three-quarters of the patients had had nutrition (75.2%). The ROS1 mutation was present in 1 patient. PDL-1 expression was >40% in 2 patients. Survival was mean eight months ± 7.4. Conclusion: Lung cancer is diagnosed at a late stage in Tunisia. The lack of molecular study for non-small cell PBC and the lack of marketing authorization for tyrosine kinase inhibitors in Tunisia make the management incomplete.

Keywords: SCLC, NCSLC, ROS1, PDL1

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Authors: A. I. Khalafalla, K. A. Al-Busada, I. M. El-Sabagh

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Pox and pox-like diseases of camels are a group of exanthematous skin conditions that have become increasingly important economically. They may be caused by three distinct viruses: camelpox virus (CMPV), camel contagious ecthyma virus (CCEV) and camel papillomavirus (CAPV). These diseases are difficult to differentiate based on clinical presentation in disease outbreaks. Molecular methods such as PCR targeting species-specific genes have been developed and used to identify CMPV and CCEV, but not simultaneously in a single tube. Recently, multiplex PCR has gained reputation as a convenient diagnostic method with cost- and time–saving benefits. In the present communication, we describe the development, optimization and validation a multiplex PCR assays able to detect simultaneously the genome of the three viruses in one single test allowing for rapid and efficient molecular diagnosis. The assay was developed based on the evaluation and combination of published and new primer sets, and was applied to the detection of 110 tissue samples. The method showed high sensitivity, and the specificity was confirmed by PCR-product sequencing. In conclusion, this rapid, sensitive and specific assay is considered a useful method for identifying three important viruses in specimens from camels and as part of a molecular diagnostic regime.

Keywords: multiplex PCR, diagnosis, pox and pox-like diseases, camels

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Authors: Andrew White, Abigail Lowe, Kory Watkins, Hamed Akhlaghi, Nicole Winter

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The timing and appropriateness of diagnostic imaging are critical to the evaluation and management of traumatic injuries. Within the subclass of trauma patients, the prevalence of c-spine injury is less than 4%. However, the incidence of delayed diagnosis within this cohort has been documented as up to 20%, with inadequate radiological examination most cited issue. In order to assess those in which c-spine injury cannot be fully excluded based on clinical examination alone and, therefore, should undergo diagnostic imaging, a set of criteria is used to provide clinical guidance. The NEXUS (National Emergency X-Radiography Utilisation Study) criteria is a validated clinical decision-making tool used to facilitate selective c-spine radiography. The criteria allow clinicians to determine whether cervical spine imaging can be safely avoided in appropriate patients. The NEXUS criteria are widely used within the Emergency Department setting given their ease of use and relatively straightforward application and are used in the Victorian State Trauma System’s guidelines. This audit utilized retrospective data collection to examine the concordance of c-spine imaging in trauma patients to that of the NEXUS criteria and assess compliance with state guidance on diagnostic imaging in trauma. Of the 183 patients that presented with trauma to the head, neck, or face (244 excluded due to incorrect triage), 98 did not undergo imaging of the c-spine. Out of those 98, 44% fulfilled at least one of the NEXUS criteria, meaning the c-spine could not be clinically cleared as per the current guidelines. The criterion most met was intoxication, comprising 42% (18 of 43), with midline spinal tenderness (or absence of documentation of this) the second most common with 23% (10 of 43). Intoxication being the most met criteria is significant but not unexpected given the cohort of patients seen at St Vincent’s and within many emergency departments in general. Given these patients will always meet NEXUS criteria, an element of clinical judgment is likely needed, or concurrent use of the Canadian C-Spine Rules to exclude the need for imaging. Midline tenderness as a met criterion was often in the context of poor or absent documentation relating to this, emphasizing the importance of clear and accurate assessments. The distracting injury was identified in 7 out of the 43 patients; however, only one of these patients exhibited a thoracic injury (T11 compression fracture), with the remainder comprising injuries to the extremities – some studies suggest that C-spine imaging may not be required in the evaluable blunt trauma patient despite distracting injuries in any body regions that do not involve the upper chest. This emphasises the need for standardised definitions for distracting injury, at least at a departmental/regional level. The data highlights the currently poor application of the NEXUS guidelines, with likely common themes throughout emergency departments, highlighting the need for further education regarding implementation and potential refinement/clarification of criteria. Of note, there appeared to be no significant differences between levels of experience with respect to inappropriately clearing the c-spine clinically with respect to the guidelines.

Keywords: imaging, guidelines, emergency medicine, audit

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Authors: Maha Salah Abdullah Ismail, Mahmoud M. Alsagheir, Mohammed Salah Abd Allah

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Acute respiratory distress syndrome (ARDS) is characterized by permeability pulmonary edema and refractory hypoxemia. Lung-protective ventilation is still the key of better outcome in ARDS. Prone position reduces the trans-pulmonary pressure gradient, recruiting collapsed regions of the lung without increasing airway pressure or hyperinflation. Prone ventilation showed improved oxygenation and improved outcomes in severe hypoxemic patients with ARDS. This study evaluates the effect of prone positioning on mechanically ventilated patients with ARDS. A quasi-experimental design was carried out at Critical Care Units, on 60 patients. Two tools were utilized to collect data; Socio demographic, medical and clinical outcomes data sheet. Results of the present study indicated that prone position improves oxygenation in patients with severe respiratory distress syndrome. The study recommended that use prone position in patients with severe ARDS, as early as possible and for long sessions. Also, replication of this study on larger probability sample at the different geographical location is highly recommended.

Keywords: acute respiratory distress syndrome, critical care, mechanical ventilation, prone position

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Authors: Dana Aljadaa, Hasim Altan

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Japan’s strategy is based on improving the current resources and productivity by identifying the environmental challenges to progress further in many areas. For example, it will help in understanding the competitive challenges in the industry, emerging innovation, and other progresses. The present study seeks to examine the characteristics of sustainable practices using materials that will last longer and following environmental policies. There has been a major emphasis since 1990s and onwards about recycling and preserving the environment. Furthermore, the present paper analyses and argues how national interest in policy increases resource productivity. It is a universal law, but these actions may be different based on the unique situation of the country. In addition, the present study explains some of the strategies developed by the Environmental Agency of Japan in the last few years. There are a few resources reviewed involving ‘Strategy for an Environmental Nation in the 21st Century’ from 2001, ‘Clean Asia Initiative’ from 2008, and ‘New Growth Strategy’ from 2010. The present paper also highlights the emphasis on increasing efficiency, as it is an important part of sustainability. We finally conclude by providing reasoning on the impact and positivity of reducing production and consumption on the environment, resulting in a productive and progressive Japan for the near and long term future.

Keywords: eco-system, resource productivity, sound material-cycle, sustainable development

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Authors: Yan Cheng, Yijun Shao, James Rudolph, Charlene R. Weir, Beth Sahlmann, Qing Zeng-Treitler

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Supervised predictive models require labeled data for training purposes. Complete and accurate labeled data, i.e., a ‘gold standard’, is not always available, and imperfectly labeled data may need to serve as an alternative. An important question is if the accuracy of the labeled data creates a performance ceiling for the trained model. In this study, we trained several models to recognize the presence of delirium in clinical documents using data with annotations that are not completely accurate (i.e., weakly-supervised learning). In the external evaluation, the support vector machine model with a linear kernel performed best, achieving an area under the curve of 89.3% and accuracy of 88%, surpassing the 80% accuracy of the training sample. We then generated a set of simulated data and carried out a series of experiments which demonstrated that models trained on imperfect data can (but do not always) outperform the accuracy of the training data, e.g., the area under the curve for some models is higher than 80% when trained on the data with an error rate of 40%. Our experiments also showed that the error resistance of linear modeling is associated with larger sample size, error type, and linearity of the data (all p-values < 0.001). In conclusion, this study sheds light on the usefulness of imperfect data in clinical research via weakly-supervised learning.

Keywords: weakly-supervised learning, support vector machine, prediction, delirium, simulation

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Authors: Pedro Felgueiras, Ana Miguel, Nélson Almeida, Raquel Silva

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Objective: Through the study of a clinical case of delusional somatic disorder secondary to phantogeusia, we aim to highlight the importance of considering psychosomatic conditions in differential diagnosis, as well as to emphasize the complexity of its comprehension, treatment, and respective impact on patients’ functioning. Methods: Bearing this in mind, we conducted a critical analysis of a case series based on patient observations, clinical data, and complementary diagnostic methods, as well as a non-systematic review of the literature on the subject. Results: A 61-year-old female patient with no history of psychiatric conditions. Family psychiatric history of mood disorder (depression), with psychotic features found in her mother. Medical history of many comorbidities affecting different organ systems (endocrine, gastrointestinal, genitourinary, ophthalmological). Documented neuroticism traits of personality. The patient’s family described a persistent concern about several physical symptoms across her life, with a continuous effort to obtain explanations about any sensation out of her normal perception. Since being subjected to endoscopy in 2018, she started complaints of persistent phantogeusia (acid taste) and developed excessive thoughts, feelings, and behaviors associated with this somatic symptom. The patient was evaluated by several medical specialties, and an extensive panel of medical exams was carried out, excluding any disease. Besides all the investigation and with no evidence of disease signs, acute anxiety, time, and energy dispended to this symptom culminated in severe psychosocial impairment. The patient was admitted to a psychiatric ward for investigation and treatment of this clinical picture, leading to the diagnosis of the delusional somatic disorder. In order to exclude the acute organic etiology of this psychotic disorder, an analytic panel was carried out with no abnormal results. In the context of a psychotic clinical picture, a CT scan was performed, which revealed a right cortical vascular lesion. Neuropsychological evaluation was made, with the description of cognitive functioning being globally normative. During treatment with an antipsychotic (pimozide), a complete remission of the somatic delusion was associated with the disappearance of gustative perception disturbance. In follow-up, a relapse of gustative sensation was documented, and her thoughts and speech were dominated by concerns about multiple somatic symptoms. Conclusion: In terms of abnormal bodily sensations, the oral cavity is one of the frequent sites of delusional disorder. Patients with these gustatory perception distortions complain about unusual sensations without corresponding abnormal findings in the oral area. Its pathophysiology has not been fully elucidated yet. In terms of its comprehensive psychopathology, this case was hypothesized as a paranoid development of a delusional somatic disorder triggered by a post-invasive procedure phantogeusia (which is described as a possible side effect of an endoscopy) in a patient with an anankastic personality. This case presents interesting psychopathology, reinforcing the complexity of psychosomatic disorders in terms of their etiopathogenesis, clinical treatment, and long-term prognosis.

Keywords: psychosomatics, delusional somatic disorder, phantogeusia, paranoid development

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Authors: Mitakshara Sharma, Sonal Sharma

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Vesiculobullous diseases are heterogeneous group of dermatological disorders with protean manifestations. The most important technique for the patients with vesiculobullous diseases is conventional histopathology and confirmatory tests like direct immunofluorescence (DIF) and indirect immunofluorescence (IIF). DIF has been used for decades to investigate pathophysiology and in the diagnosis. It detects molecules such as immunoglobulins and complement components. It is done on the perilesional skin. Diagnosis of DIF test depends on features like primary site of the immune deposits, class of immunoglobulin, number of immune deposits and deposition at other sites. The aim of the study is to correlate DIF with clinical and histopathological findings and to analyze the utility of DIF in the diagnosis of these disorders. It is a retrospective descriptive study conducted for 2 years from 2015 to 2017 in Department of Pathology, GTB Hospital on perilesional punch biopsies of vesiculobullous lesions. Biopsies were sent in Michael’s medium. The specimens were washed, frozen and incubated with fluorescein isothiocyanate (FITC) tagged antihuman antibodies IgA, IgG, IgM, C3 & F and were viewed under fluorescent microscope. Out of 401 skin biopsies submitted for DIF, 285 were vesiculobullous diseases, in which the most common was Pemphigus vulgaris (34%) followed by Bullous pemphigoid (21.5%), Dermatitis herpetiformis (16%), Pemphigus foliaceus (11.9%), Linear IgA disease (11.9%), Epidermolysisbullosa (2.39%) and Pemphigus herpetiformis (1.7%). We will be presenting the DIF findings in the all these vesiculobullous diseases. DIF in conjugation with histopathology gives the best diagnostic yield in these lesions. It also helps in the diagnosis whenever there is a clinical and histopathological overlap.

Keywords: antibodies, direct immunofluorescence, pemphigus, vesiculobullous

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Authors: Jamboor K. Vishwanatha

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Among the potent anti-cancer agents, curcumin has been found to be very efficacious against various cancer cells. Despite multiple medicinal benefits of curcumin, poor water solubility, poor physiochemical properties and low bioavailability continue to pose major challenges in developing a formulation for clinical efficacy. To improve its potential application in the clinical area, we formulated poly lactic-co-glycolic acid (PLGA) nanoparticles. The PLGA nanoparticles were formulated using solid-oil/water emulsion solvent evaporation method and then characterized for percent yield, encapsulation efficiency, surface morphology, particle size, drug distribution within nanoparticles and drug polymer interaction. Our studies showed the successful formation of smooth and spherical curcumin loaded PLGA nanoparticles with a high percent yield of about 92.01±0.13% and an encapsulation efficiency of 90.88±0.14%. The mean particle size of the nanoparticles was found to be 145nm. The in vitro drug release profile showed 55-60% drug release from the nanoparticles over a period of 24 hours with continued sustained release over a period of 8 days. Exposure to curcumin loaded nanoparticles resulted in reduced cell viability of cancer cells compared to normal cells. We used a novel non-covalent insertion of a homo-bifunctional spacer for targeted delivery of curcumin to various cancer cells. Functionalized nanoparticles for antibody/targeting agent conjugation was prepared using a cross-linking ligand, bis(sulfosuccinimidyl) suberate (BS3), which has reactive carboxyl group to conjugate efficiently to the primary amino groups of the targeting agents. In our studies, we demonstrated successful conjugation of antibodies, Annexin A2 or prostate specific membrane antigen (PSMA), to curcumin loaded PLGA nanoparticles for targeting to prostate and breast cancer cells. The percent antibody attachment to PLGA nanoparticles was found to be 92.8%. Efficient intra-cellular uptake of the targeted nanoparticles was observed in the cancer cells. These results have emphasized the potential of our multifunctional curcumin nanoparticles to improve the clinical efficacy of curcumin therapy in patients with cancer.

Keywords: polymeric nanoparticles, cancer therapy, sustained release, curcumin

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Authors: Ayda Youssef, Tarek Rafaat, Iman zaky

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Purpose: Langerhans’ cell histiocytosis (LCH) is not uncommon pathology that implies aberrant proliferation of a specific dendritic (Langerhans) cell. These atypical but mature cells of monoclonal origin can infiltrate many sites of the body and may occur as localized lesions or as widespread systemic disease. Liver is one of the uncommon sites of affection. The twofold objective of this study is to illustrate the radiological presentation of this disease, and to compare these results with previously reported series. Methods and Materials: Between 2007 and 2012, 150 patients with biopsy-proven LCH were treated in our hospital, a paediatric cancer tertiary care center. A retrospective review of radiographic images and reports was performed. There were 33 patients with liver affection are stratified. All patients underwent imaging studies, mostly US and CT. A chart review was performed to obtain demographic, clinical and radiological data. They were analyzed and compared to other published series. Results: Retrospective assessment of 150 patients with LCH was performed, among them 33 patients were identified who had liver involvement. All these patients developed multisystemic disease; They were 12 females and 21 males with (n= 32), seven of them had marked hepatomegaly. Diffuse hypodense liver parenchyma was encountered in five cases, the periportal location has a certain predilection in cases of focal affection where three cases has a hypodense periportal soft tissue sheets, one of them associated with dilated biliary radicals, only one case has multiple focal lesions unrelated to portal tracts. On follow up of the patients, two cases show abnormal morphology of liver with bossy outline. Conclusion: LCH is a not infrequent disease. A high-index suspicion should be raised in the context of diagnosis of liver affection. A biopsy is recommended in the presence of radiological suspicion. Chemotherapy is the preferred therapeutic modality. Liver histiocytosis are not disease specific features but should be interpreted in conjunction with the clinical history and the results of biopsy. Clinical Relevance/Application: Radiologist should be aware of different patterns of hepatobiliary histiocytosis, Thus early diagnosis and proper management of patient can be conducted.

Keywords: langerhans’ cell histiocytosis, liver, medical and health sciences, radiology

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Authors: Ronak Mishra, Sachin Kale

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Background: The clinical outcome of a new fixation device (femoral neck system, FNS) for femoral neck fractures is not described properly. The main purpose of this study was to evaluate the functional outcome of the patients of femoral neck fractures treated with FNS. Methods: A retrospective study was done among patients aged 60 years or less. On the basis of inclusion and exclusion criteria a final sample size of 30 was considered. Blood loss, type of fracture internal fixation, and length of clinical follow-up were all acquired from patient records. The volume of blood loss was calculated. The mean and standard deviation of continuous variables were reported (with range). Harris Hip score (HHS) And Post op xrays at intervals(6 weeks, 6 months ,12 months ) we used to clinically asses the patient. Results: Out of all 60% were females and 40% were males. The mean age of the patients was. 44.12(+-) years The comparison of functional outcomes of the patients treated with FNS using Harris Hip Score. It showed a highly significant comparison between the patients at post operatively , 6 weeks and 3 months and 12 months . There were no postoperative complications seen among the patients. Conclusion: FNS offers superior biomechanical qualities and greatly improved overall build stability. It allows for a significant reduction in operation time, potentially lowering risks and consequences associated with surgery.

Keywords: FNS, trauma, hip, neck femur fracture, minimally invasive surgery

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Authors: Jean Paul M. Milambo

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Purpose: Aromatase inhibitors (AIs) are indicated in the treatment of hormone-receptive breast cancer in postmenopausal women in various settings. Studies have shown cardiovascular events in some developed countries. To date the data is sparce for evidence-based recommendations in African clinical settings due to lack of cancer registries, capacity building and surveillance systems. Therefore, this study was conducted to assess the feasibility of HyBeacon® probe genotyping adjunctive to standard care for timely prediction and diagnosis of Aromatase inhibitors (AIs) associated adverse events in breast cancer survivors in Africa. Methods: Cross sectional study was conducted to assess the knowledge of POCT among six African countries using online survey and telephonically contacted. Incremental cost effectiveness ratio (ICER) was calculated, using diagnostic accuracy study. This was based on mathematical modeling. Results: One hundred twenty-six participants were considered for analysis (mean age = 61 years; SD = 7.11 years; 95%CI: 60-62 years). Comparison of genotyping from HyBeacon® probe technology to Sanger sequencing showed that sensitivity was reported at 99% (95% CI: 94.55% to 99.97%), specificity at 89.44% (95% CI: 87.25 to 91.38%), PPV at 51% (95%: 43.77 to 58.26%), and NPV at 99.88% (95% CI: 99.31 to 100.00%). Based on the mathematical model, the assumptions revealed that ICER was R7 044.55. Conclusion: POCT using HyBeacon® probe genotyping for AI-associated adverse events maybe cost effective in many African clinical settings. Integration of preventive measures for early detection and prevention guided by different subtype of breast cancer diagnosis with specific clinical, biomedical and genetic screenings may improve cancer survivorship. Feasibility of POCT was demonstrated but the implementation could be achieved by improving the integration of POCT within primary health cares, referral cancer hospitals with capacity building activities at different level of health systems. This finding is pertinent for a future envisioned implementation and global scale-up of POCT-based initiative as part of risk communication strategies with clear management pathways.

Keywords: breast cancer, diagnosis, point of care, South Africa, aromatase inhibitors

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Authors: Lucas Derks, Christine Beenhakker, Michiel Brandt, Gert Arts, Ruud van Langeveld

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Background: The method Depression in Awareness Space (DAS) is a psychotherapeutic intervention technique based on the principles of spatial cognition and imagination therapy with spatial components. The basic assumptions are: mental space is the primary organizing principle in the mind, and all psychological issues can be treated by first locating and by next relocating the conceptualizations involved. The most clinical experience was gathered over the last 20 years in the area of social issues (with the social panorama model). The latter work led to the conclusion that a mental object (image) gains emotional impact when it is placed more central, closer and higher in the visual field – and vice versa. Changing the locations of mental objects in space thus alters the (socio-) emotional meaning of the relationships. The experience of depression seems always associated with darkness. Psychologists tend to see the link between depression and darkness as a metaphor. However, clinical practice hints to the existence of more literal forms of darkness. Aims: The aim of the method Depression in Awareness Space is to reduce the distress of clients with depression in the clinical counseling practice, as a reliable alternative method of psychological therapy for the treatment of depression. The method Depression in Awareness Space aims at making dark areas smaller, lighter and more transparent in order to identify the problem or the cause of the depression which lies behind the darkness. It was hypothesized that the darkness is a subjective side-effect of the neurological process of repression. After reducing the dark clouds the real problem behind the depression becomes more visible, allowing the client to work on it and in that way reduce their feelings of depression. This makes repression of the issue obsolete. Results: Clients could easily get into their 'sadness' when asked to do so and finding the location of the dark zones proved pretty easy as well. In a recent pilot study with five participants with mild depressive symptoms (measured on two different scales and tested against an untreated control group with similar symptoms), the first results were also very promising. If the mental spatial approach to depression can be proven to be really effective, this would be very good news. The Society of Mental Space Psychology is now looking for sponsoring of an up scaled experiment. Conclusions: For spatial cognition and the research into spatial psychological phenomena, the discovery of dark areas can be a step forward. Beside out of pure scientific interest, it is great to know that this discovery has a clinical implication: when darkness can be connected to depression. Also, darkness seems to be more than metaphorical expression. Progress can be monitored over measurement tools that quantify the level of depressive symptoms and by reviewing the areas of darkness.

Keywords: depression, spatial cognition, spatial imagery, social panorama

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Authors: Bill D. Geis

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Suicide wrongful death forensic cases are the fastest rising tort in mental health law. It is estimated that suicide-related cases have accounted for 15% of U.S. malpractice claims since 2006. Most suicide-related personal injury claims fall into the legal category of “wrongful death.” Though mental health experts may be called on to address a range of forensic questions in wrongful death cases, the central consultation that most experts provide is about the negligence element—specifically, the issue of whether the clinician met the clinical standard of care in assessing, treating, and managing the deceased person’s mental health care. Standards of care, varying from U.S. state to state, are broad and address what a reasonable clinician might do in a similar circumstance. This fact leaves the issue of the suicide standard of care, in each case, up to forensic experts to put forth a reasoned estimate of what the standard of care should have been in the specific case under litigation. Because the general state guidelines for standard of care are broad, forensic experts are readily retained to provide scientific and clinical opinions about whether or not a clinician met the standard of care in their suicide assessment, treatment, and management of the case. In the past and in much of current practice, the assessment of suicide has centered on the elicitation of verbalized suicide ideation. Research in recent years, however, has indicated that the majority of persons who end their lives do not say they are suicidal at their last medical or psychiatric contact. Near-term risk assessment—that goes beyond verbalized suicide ideation—is needed. Our previous research employed structural equation modeling to predict lethal suicide risk--eight negative thought patterns (feeling like a burden on others, hopelessness, self-hatred, etc.) mediated by nine transdiagnostic clinical factors (mental torment, insomnia, substance abuse, PTSD intrusions, etc.) were combined to predict acute lethal suicide risk. This structural equation model, the Lethal Suicide Risk Pattern (LSRP), Acute model, had excellent goodness-of-fit [χ2(df) = 94.25(47)***, CFI = .98, RMSEA = .05, .90CI = .03-.06, p(RMSEA = .05) = .63. AIC = 340.25, ***p < .001.]. A further SEQ analysis was completed for this paper, adding a measure of Acute Suicide Ideation to the previous SEQ. Acceptable prediction model fit was no longer achieved [χ2(df) = 3.571, CFI > .953, RMSEA = .075, .90% CI = .065-.085, AIC = 529.550].This finding suggests that, in this additional study, immediate verbalized suicide ideation information was unhelpful in the assessment of lethal risk. The LSRP and other dynamic, near-term risk models (such as the Acute Suicide Affective Disorder Model and the Suicide Crisis Syndrome Model)—going beyond elicited suicide ideation—need to be incorporated into current clinical suicide assessment training. Without this training, the standard of care for suicide assessment is out of sync with current research—an emerging dilemma for the forensic evaluation of suicide wrongful death cases.

Keywords: forensic evaluation, standard of care, suicide, suicide assessment, wrongful death

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Authors: Madeline Foster

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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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Authors: Claire Xu, Welton Wang, Manasvi Pinnaka, Anqi Pan, Michael Han

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Hospitalizations account for one-third of the total health care spending in the US. Early risk detection and intervention can reduce this high cost and increase the satisfaction of both patients and physicians. Due to the lack of awareness of the potential arising risks in home environment, the opportunities for patients to seek early actions of clinical visits are dramatically reduced. This research aims to offer a highly personalized remote patients monitoring and risk assessment AI framework to identify the potentially preventable hospitalization for both acute as well as chronic diseases. A hybrid-AI framework is trained with data from clinical setting, patients surveys, as well as online databases. 20+ risk factors are analyzed ranging from activities, biometric info, demographic info, socio-economic info, hospitalization history, medication info, lifestyle info, etc. The AI model yields high performance of 87% accuracy and 88 sensitivity with 20+ features. This hybrid-AI framework is proven to be effective in identifying the potentially preventable hospitalization. Further, the high indicative features are identified by the models which guide us to a healthy lifestyle and early intervention suggestions.

Keywords: hospitalization prevention, machine learning, remote patient monitoring, risk prediction

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Authors: Harsh Sadawarti, Kamal Malik

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Humans are the unique and the most powerful creature on this planet just because of the high level of intelligence gifted by nature. Computational Intelligence is highly influenced by the term natural intelligence, neurosciences and mathematics. To deal with the in-depth study of computational intelligence and to utilize it in real-life applications, it is quite important to understand its simulation with the human brain. In this paper, the three important parts, Frontal Lobe, Occipital Lobe and Parietal Lobe of the human brain, are compared with the ANN(Artificial Neural Network), CNN(Convolutional Neural network), and RNN(Recurrent Neural Network), respectively. Intelligent computational systems are created by combining deductive reasoning, logical concepts and high-level algorithms with the simulation and study of the human brain. Human brain is a combination of Physiology, Psychology, emotions, calculations and many other parameters which are of utmost importance that determines the overall intelligence. To create intelligent algorithms, smart machines and to simulate the human brain in an effective manner, it is quite important to have an insight into the human brain and the basic concepts of biological neurosciences.

Keywords: computational intelligence, neurosciences, convolutional neural network, recurrent neural network, artificial neural network, frontal lobe, occipital lobe, parietal lobe

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Authors: Pamela Ventola, Laurel Bales, Sara Florczyk

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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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Authors: F. Ruiz-Fuster

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Arnold’s redefinition of human motives can sustain a psychology of education which emphasizes the beauty of knowledge and the exercise of intellectual functions. Thus, education instead of focusing on skills and learning by doing would be centered on ‘the widest reaches of the human spirit’. One way to attain it is by developing children’s inherent interest. Arnold takes into account the fact that the desire to know is the inherent interest which leads students to explore and learn. She also emphasizes the need of exercising human functions as thinking, judging and reasoning. According to Arnold, the influence of psychological theories of motivation in education has derived in considering that all learning and school tasks should derive from children’s needs and impulses. The desire to know and the curiosity have not been considered as basic and active as any instinctive drive or basic need, so there has been an attempt to justify and understand how biological drives guide student’s learning. However, understanding motives and motivation not as a drive, an instinct or an impulse guided by our basic needs, but as a want that leads to action can help to understand, from a psychological perspective, how teachers can motivate students to learn, strengthening their desire and interest to reason and discover the whole new world of knowledge.

Keywords: academic motivation, interests, desire to know, educational psychology, intellectual functions

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