Search results for: clinical study

Authors: Sneha Shankar, Orlando Buendia, Will Evans

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Alpha-1 antitrypsin deficiency (AATD) is a rare, genetic, and multisystemic condition. Underdiagnosis is common, leading to chronic pulmonary and hepatic complications, increased resource utilization, and additional costs to the healthcare system. Currently, there is limited evidence of the direct medical costs of AATD diagnosis in the UK. This study explores the economic impact of AATD patients during the 3 years before diagnosis and to identify the major cost drivers using primary and secondary care electronic health record (EHR) data. The 3 years before diagnosis time period was chosen based on the ability of our tool to identify patients earlier. The AATD algorithm was created using published disease criteria and applied to 148 known AATD patients’ EHR found in a primary care database of 936,148 patients (413,674 Biobank and 501,188 in a single primary care locality). Among 148 patients, 9 patients were flagged earlier by the tool and, on average, could save 3 (1-6) years per patient. We analysed 101 of the 148 AATD patients’ primary care journey and 20 patients’ Hospital Episode Statistics (HES) data, all of whom had at least 3 years of clinical history in their records before diagnosis. The codes related to laboratory tests, clinical visits, referrals, hospitalization days, day case, and inpatient admissions attributable to AATD were examined in this 3-year period before diagnosis. The average cost per patient was calculated, and the direct medical costs were modelled based on the mean prevalence of 100 AATD patients in a 500,000 population. A deterministic sensitivity analysis (DSA) of 20% was performed to determine the major cost drivers. Cost data was obtained from the NHS National tariff 2020/21, National Schedule of NHS Costs 2018/19, PSSRU 2018/19, and private care tariff. The total direct medical cost of one hundred AATD patients three years before diagnosis in primary and secondary care in the UK was £3,556,489, with an average direct cost per patient of £35,565. A vast majority of this total direct cost (95%) was associated with inpatient admissions (£3,378,229). The DSA determined that the costs associated with tier-2 laboratory tests and inpatient admissions were the greatest contributors to direct costs in primary and secondary care, respectively. This retrospective study shows the role of EHRs in calculating direct medical costs and the potential benefit of new technologies for the early identification of patients with AATD to reduce the economic burden in primary and secondary care in the UK.

Keywords: alpha-1 antitrypsin deficiency, costs, digital health, early diagnosis

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Authors: Subhash Nerella, Ziyuan Guan, Azra Bihorac, Parisa Rashidi

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Intensive care units (ICUs) provide care to critically ill patients in severe and life-threatening conditions. However, patient monitoring in the ICU is limited by the time and resource constraints imposed on healthcare providers. Many critical care indices such as mobility are still manually assessed, which can be subjective, prone to human errors, and lack granularity. Other important aspects, such as environmental factors, are not monitored at all. For example, critically ill patients often experience circadian disruptions due to the absence of effective environmental “timekeepers” such as the light/dark cycle and the systemic effect of acute illness on chronobiologic markers. Although the occurrence of delirium is associated with circadian disruption risk factors, these factors are not routinely monitored in the ICU. Hence, there is a critical unmet need to develop systems for precise and real-time assessment through novel enabling technologies. We have developed the mobility and circadian disruption quantification system (Mobi-DiQ) by augmenting biomarker and clinical data with pervasive sensing data to generate mobility and circadian cues related to mobility, nightly disruptions, and light and noise exposure. We hypothesize that Mobi-DiQ can provide accurate mobility and circadian cues that correlate with bedside clinical mobility assessments and circadian biomarkers, ultimately important for delirium risk assessment and prevention. The collected multimodal dataset consists of depth images, Electromyography (EMG) data, patient extremity movement captured by accelerometers, ambient light levels, Sound Pressure Level (SPL), and indoor air quality measured by volatile organic compounds, and the equivalent CO₂ concentration. For delirium risk assessment, the system recognizes mobility cues (axial body movement features and body key points) and circadian cues, including nightly disruptions, ambient SPL, and light intensity, as well as other environmental factors such as indoor air quality. The Mobi-DiQ system consists of three major components: the pervasive sensing system, a data storage and analysis server, and a data annotation system. For data collection, six local pervasive sensing systems were deployed, including a local computer and sensors. A video recording tool with graphical user interface (GUI) developed in python was used to capture depth image frames for analyzing patient mobility. All sensor data is encrypted, then automatically uploaded to the Mobi-DiQ server through a secured VPN connection. Several data pipelines are developed to automate the data transfer, curation, and data preparation for annotation and model training. The data curation and post-processing are performed on the server. A custom secure annotation tool with GUI was developed to annotate depth activity data. The annotation tool is linked to the MongoDB database to record the data annotation and to provide summarization. Docker containers are also utilized to manage services and pipelines running on the server in an isolated manner. The processed clinical data and annotations are used to train and develop real-time pervasive sensing systems to augment clinical decision-making and promote targeted interventions. In the future, we intend to evaluate our system as a clinical implementation trial, as well as to refine and validate it by using other data sources, including neurological data obtained through continuous electroencephalography (EEG).

Keywords: deep learning, delirium, healthcare, pervasive sensing

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Authors: Srinivas Bathini, Duraichelvan Raju, Simona Badilescu, Muthukumaran Packirisamy

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A bio-sensing method, based on the plasmonic property of gold nano-islands, has been developed for detection of exosomes in a clinical setting. The position of the gold plasmon band in the UV-Visible spectrum depends on the size and shape of gold nanoparticles as well as on the surrounding environment. By adsorbing various chemical entities, or binding them, the gold plasmon band will shift toward longer wavelengths and the shift is proportional to the concentration. Exosomes transport cargoes of molecules and genetic materials to proximal and distal cells. Presently, the standard method for their isolation and quantification from body fluids is by ultracentrifugation, not a practical method to be implemented in a clinical setting. Thus, a versatile and cutting-edge platform is required to selectively detect and isolate exosomes for further analysis at clinical level. The new sensing protocol, instead of antibodies, makes use of a specially synthesized polypeptide (Vn96), to capture and quantify the exosomes from different media, by binding the heat shock proteins from exosomes. The protocol has been established and optimized by using a glass substrate, in order to facilitate the next stage, namely the transfer of the protocol to a microfluidic environment. After each step of the protocol, the UV-Vis spectrum was recorded and the position of gold Localized Surface Plasmon Resonance (LSPR) band was measured. The sensing process was modelled, taking into account the characteristics of the nano-island structure, prepared by thermal convection and annealing. The optimal molar ratios of the most important chemical entities, involved in the detection of exosomes were calculated as well. Indeed, it was found that the results of the sensing process depend on the two major steps: the molar ratios of streptavidin to biotin-PEG-Vn96 and, the final step, the capture of exosomes by the biotin-PEG-Vn96 complex. The microfluidic device designed for sensing of exosomes consists of a glass substrate, sealed by a PDMS layer that contains the channel and a collecting chamber. In the device, the solutions of linker, cross-linker, etc., are pumped over the gold nano-islands and an Ocean Optics spectrometer is used to measure the position of the Au plasmon band at each step of the sensing. The experiments have shown that the shift of the Au LSPR band is proportional to the concentration of exosomes and, thereby, exosomes can be accurately quantified. An important advantage of the method is the ability to discriminate between exosomes having different origins.

Keywords: exosomes, gold nano-islands, microfluidics, plasmonic biosensing

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Authors: Mohammad Reza Dawoudi

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With the increasing rate of patients suffering from chronic pain, several methods for evaluating of chronic pain are suggested. Motion of morbid has been defined as the rate of pine and it is linked with various co-morbid conditions. This study provides a summary of procedure useful to statistics performing direct behavioral observation in hospital settings. We describe the need for and usefulness of comprehensive “morbid motions” observations; provide a primer on the identification, definition, and assessment of morbid behaviors; and outline and discuss specific statistical procedures, including formulating referral motions, describing and conducting the observation. We also provide practical devices for observing and analyzing the obtained information into a report that guides clinical intervention.

Keywords: assessing pain, DNA modeling, image matching technique, pain scale

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Authors: A. Dudek, P. Tylec, G. Torbicz, P. Duda, K. Proniewska, P. Major, M. Pedziwiatr

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Background: Conservative treatments of obesity, based only on a proper diet and physical activity, without the support of an interdisciplinary team of specialist does not bring satisfactory bariatric results. Long-term maintenance of a proper metabolic results after rapid weight loss due to bariatric surgery requires engagement from patients. Mobile health tool may offer alternative model that enhance participant engagement in keeping the therapy. Objective: We aimed to assess the influence of constant monitoring and subsequent motivational alerts in perioperative period and on post-operative effects in the bariatric patients. As well as the study was designed to identify factors conductive urge to change lifestyle after surgery. Methods: This prospective clinical control study was based on a usage of a designed prototype of bariatric mHealth system. The prepared application comprises central data management with a comprehensible interface dedicated for patients and data transfer module as a physician’s platform. Motivation system of a platform consist of motivational alerts, graphic outcome presentation, and patient communication center. Generated list of patients requiring urgent consultation and possibility of a constant contact with a specialist provide safety zone. 31 patients were enrolled in continuous monitoring program during a 6-month period along with typical follow-up visits. After one year follow-up, all patients were examined. Results: There were 20 active users of the proposed monitoring system during the entire duration of the study. After six months, 24 patients took a part in a control by telephone questionnaires. Among them, 75% confirmed that the application concept was an important element in the treatment. Active users of the application indicated as the most valuable features: motivation to continue treatment (11 users), graphical presentation of weight loss, and other parameters (7 users), the ability to contact a doctor (3 users). The three main drawbacks are technical errors (9 users), tedious questionnaires inside the application (5 users), and time-consuming tasks inside the system (2 users). Conclusions: Constant monitoring and successive motivational alerts to continue treatment is an appropriate tool in the treatment after bariatric surgery, mainly in the early post-operative period. Graphic presentation of data and continuous connection with a clinical staff seemed to be an element of motivation to continue treatment and a sense of security.

Keywords: bariatric surgery, mHealth, mobile health tool, obesity

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Authors: Sabreen Al Shamli, Abdul Rahman Al azure

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Microscopic examination by histopathology is the gold standard for diagnosing many oral and maxillofacial pathologies. Current clinical guidelines and medicolegal regulations recommend the utilization of histopathology services for confirming pathologies being treated. The goal of this study was to determine the prevalence and distribution of oral and maxillofacial biopsies that had been histopathologically diagnosed at Anahdha Hospital (ANH). A total of 512 biopsies randomly selected from a ground total of 3310 biopsies, which were submitted for oral and maxillofacial histopathological specimens, were analyzed at Nahdha Hospital in Oman between January 2010 and December 2022. Data collected retrospectively selected from all case notes of patients who had oral histopathology examinations performed as part of their treatment. Data collected from the Shifa system was transferred to Microsoft Excel and analyzed using SPSS. Research ethics approval was obtained from the research committee of the hospital. This study provides background information on oral histopathology prevalence that could be helpful in future research in Oman. The findings of the present study are in agreement with the reported data from other investigations, even when it is taken into account how difficult it is to compare prevalence rates from different studies.

Keywords: oral biopsy, maxillofacial histopathology, oral disease, maxillofacial specimens

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Authors: P. P. Chandrasekera, P. B. Hewavithana, S. Rosairo, M. H. M. N. Herath, D. M. R. D. Mirihella

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Periventricular Leukomalacia (PVL) is a White Matter Injury (WMI) of preterm neonatal brain. Objectives of the study were to assess the neuro-developmental outcome at one year of age and to determine a good protocol of cranial ultrasonography to detect PVL. Two hundred and sixty four preterm neonates were included in the study. Series of cranial ultrasound scans were done by using a dedicated neonatal head probe 4-10 MHz of Logic e portable ultrasound scanner. Clinical history of seizures, abnormal head growth (hydrocephalus or microcephaly) and developmental milestones were assessed and neurological examinations were done until one year of age. Among live neonates, 57% who had cystic PVL (Grades2 and 3) manifested as cerebral palsy. In conclusion cystic PVL has permanent neurological disabilities like cerebral palsy. Good protocol of real time cranial ultrasonography to detect PVL is to perform scans at least once a week until one month and at term (40 weeks of gestation).

Keywords: cerebral palsy, cranial ultrasonography, Periventricular Leukomalacia, preterm neonates

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Authors: Alba Prats-Bisbe, Jaume López-Carballo, David Leno-Colorado, Alberto García Molina, Alicia Romero Marquez, Elena Hernández Pena, Eloy Opisso Salleras, Raimon Jané Campos

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Neurological disorders are a leading cause of disability and premature mortality worldwide. Neurorehabilitation (NRHB) is a clinical process aimed at reducing functional impairment, promoting societal participation, and improving the quality of life for affected individuals. Virtual reality (VR) technology is emerging as a promising NRHB support tool. Its immersive nature fosters a strong sense of agency and embodiment, motivating patients to engage in meaningful tasks and increasing adherence to therapy. However, the clinical benefits of VR interventions are challenging to determine due to the high heterogeneity among health applications. This study explores a stepwise development approach for creating VR-based tools to assist individuals with neurological disorders in medical practice, aiming to enhance reproducibility, facilitate comparison, and promote the generalization of findings. Building on previous research, the step-by-step methodology encompasses: Needs Identification– conducting cross-disciplinary meetings to brainstorm problems, solutions, and address barriers. Intervention Definition– target population, set goals, and conceptualize the VR system (equipment and environments). Material Selection and Placement– choose appropriate hardware and software, place the device within the hospital setting, and test equipment. Co-design– collaboratively create VR environments, user interfaces, and data management strategies. Prototyping– develop VR prototypes, conduct user testing, and make iterative redesigns. Usability and Feasibility Assessment– design protocols and conduct trials with stakeholders in the hospital setting. Efficacy Assessment– conduct clinical trials to evaluate outcomes and long-term effects. Cost-Effectiveness Validation– assess reproducibility, sustainability, and balance between costs and benefits. NRHB is complex due to the multifaceted needs of patients and the interdisciplinary healthcare architecture. VR has the potential to support various applications, such as motor skill training, cognitive tasks, pain management, unilateral spatial neglect (diagnosis and treatment), mirror therapy, and ecologically valid activities of daily living. Following this methodology was crucial for launching a VR-based system in a real hospital environment. Collaboration with neuropsychologists lead to develop A) a VR-based tool for cognitive rehabilitation in patients with acquired brain injury (ABI). The system comprises a head-mounted display (HTC Vive Pro Eye) and 7 tasks targeting attention, memory, and executive functions. A desktop application facilitates session configuration, while database records in-game variables. The VR tool's usability and feasibility were demonstrated in proof-of-concept trials with 20 patients, and effectiveness is being tested through a clinical protocol with 12 patients completing 24-session treatment. Another case involved collaboration with nurses and paediatric physiatrists to create B) a VR-based distraction tool during invasive techniques. The goal is to alleviate pain and anxiety associated with botulinum toxin (BTX) injections, blood tests, or intravenous placements. An all-in-one headset (HTC Vive Focus 3) deploys 360º videos to improve the experience for paediatric patients and their families. This study presents a framework for developing clinically relevant and technologically feasible VR-based support tools for hospital settings. Despite differences in patient type, intervention purpose, and VR system, the methodology demonstrates usability, viability, reproducibility and preliminary clinical benefits. It highlights the importance approach centred on clinician and patient needs for any aspect of NRHB within a real hospital setting.

Keywords: neurological disorders, neurorehabilitation, stepwise development approach, virtual reality

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Authors: Aspasia Simpsi

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The aim of this study was to translate into Greek and then validate the psychometric properties of the Internet Gaming Disorder Scale–Short-Form (IGDS9-SF) (Pontes & Griffiths, 2015). This is the first short standardized psychometric tool to assess Internet Gaming Disorder (IGD) according to the DSM-V nine clinical criteria and among the most frequently examined. The translation of the test was done through the process of back-translation. To gain a better insight into the psychometric properties of this test, the questionnaire included demographic questions and the Greek version of the Internet Addiction Test (Young, 1998). The participants of the study were 241 adolescents aged between 12 to 18. They were nationally recruited in Greece through an online survey that was hosted on the platform of Qualtrics. Analysis revealed excellent reliability with Cronbach’s alpha coefficients α = .939 for IGDS9-SF and α = .940 for IAT. The use of Pearson product-moment correlation revealed a significant positive relationship between IGDS9-SF and IAT r (241) =.45, p < .001. Due to inconsistencies in terminology and tests in the field of IGD, what is recommended for future research is a consensus regarding IGD testing and research.

Keywords: internet gaming disorder, IGDS9-SF, psychometric properties, internet addiction

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Authors: L. Korpinen, P. Taskinen, P. Rautio

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This study aimed to describe procedures that we developed to use in the quantitative, bone-specific SPECT/CT at our hospital. Our procedures included the following questions for choosing imaging protocols, which were based on a clinical doctor's referral: (1) Is she/he a cancer patient or not? (2) Are there any indications of inflammatory rheumatoid arthritis? We performed about 1,106 skeletal scintigraphies over two years. About 394 patients were studied with quantitative bone-specific single-photon emission computed tomography/computerized tomography (SPECT/CT) (i.e., about 36% of all bone scintigraphies). Approximately 64% of the patients were studied using the conventional Anterior-Posterior/Posterior-Anterior imaging. Our procedure has improved efficiency and decreased cycle times.

Keywords: skeletal scintigraphy, SPECT/CT, imaging, procedure

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Authors: K. Power, M. White, B. Dunleavey, E. Comerford, C. Doherty, N. Delanty, R. Corbridge, M. Fitzsimons

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Introduction: Providing people with access to their own healthcare information and engaging them as co-authors of their health record can promote better transparency, trust, and inclusivity in the healthcare system. With the advent of electronic health records, there is a move towards involving patients as partners in their healthcare by providing them with access to their own health data via electronic patient portals (ePortal). For example, a recently developed ePortal to the Irish National Epilepsy Electronic Patient Record (EPR) provides access to summary medical records, tools for Patient Reported Outcomes (PROM), health goal-setting and preparation for clinical appointments. Aim: To determine what people with epilepsy (their families/carers) value about the Irish epilepsy ePortal. Methods: A socio-technical process was employed recruiting 30 families of people with epilepsy who also have an intellectual disability (ID). Family members who are a care partner of the person with epilepsy (PWE) were invited to co-design, develop and implement the ePortal. Family members engaged in usability and utility testing which involved a face to face meeting to learn about the ePortal, register for a user account and evaluate its structure and content. Family members were instructed to login to the portal on at least two separate occasions following the meeting and to complete a self-report evaluation tool during this time. The evaluation tool, based on a Usability Questionnaire (Lewis, 1993), consists of a short assessment of comfort using technology, instructions for using the ePortal and some tasks to complete. Tasks included validating summary record details, assessing ePortal ease of use, evaluation of information presented. Participants were asked for suggestions on how to improve the portal and make it more applicable to PWE who also have an ID. Results: Family members responded positively to the ePortal and valued the ability to share information between clinicians and care partners; use the ePortal as a passport between different healthcare settings (e.g., primary care to hospital). In the context of elderly parents of PWE, the ePortal is valued as a tool for supporting shared care between family members. Participants welcomed the facility to log lists of questions and goals to discuss with the clinician at the next clinical appointment as a means of improving quality of care. Participants also suggested further enhancements to the ePortal such as access to clinic letters which can provide an aide memoir in terms of the careplan agreed with the clinical team. For example, through the ePortal, people could see what investigations or therapies are scheduled. Conclusion: The Epilepsy Patient Portal is accessible via a range of devices such as smartphones and tablets. ePortals have the potential to help personalise care, improve patient involvement in clinical decision making, engage them as quality and safety partners, and help clinicians be more responsive to patient needs. Acknowledgement: The epilepsy ePortal project is part of PISCES, a Lighthouse Project funded by eHealth Ireland and HSE to help build an understanding of the benefits of eHealth technologies in the Irish Healthcare System.

Keywords: electronic patient portal, electronic patient record, epilepsy, intellectual disability, usability testing

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Authors: Manjunath Attibele, Alsawafi Manal, Al Dughaishi Tamima

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Introduction: The purpose of this study was to describe the clinical characteristics and types of mechanisms of injuries caused by Motor vehicle accidents (MVA) during pregnancy. To analyze the patterns of accidents during pregnancy and its adverse consequences on both maternal and fetal outcome. Methods: This was a retrospective cohort study on pregnant patients who met with MVAs The study period was from January 1, 2010, to December 31, 2019. All relevant data were retrieved from electronic patients’ records from the hospital information system and from the antenatal ward admission register Results: Out of 168 women who had motor vehicle accidents during the study period, of which, 39 (23.2%) women during pregnancy. Twenty-one (53.8%) women were over 30 years old. Thirty-five (89.7%) women were Omanis, and 27 (69.2%) were in their third trimester. Twenty-three (59%) of accidents happened at night, and 31 (79.5%) of them happened on a weekday. Twenty-two (56.4%) of women were driving themselves, and 24 (61.5%) of them were not using any seatbelt. Accident related abdominal & back pain was seen in 23(59%) women. Regarding the outcome of pregnancy, 23 (74.2%) had a normal vaginal delivery. The mean accident to delivery interval was 7 weeks. Thirty (96.7%) of involved newborns were relatively healthy. One woman (3.2%) had a ruptured uterusleading to fetal death (3.2%). Conclusion: This study showed that the incidence of motor vehicle accidents during pregnancy is around 23.2% . Majority had trauma-associated pain. One serious injury to a woman causing a ruptured uterus which lead to fetal death. Majority of involved newborns were relatively healthy. No reported maternal death.

Keywords: motor vehicle accidents, pregnancy, maternal outcome, fetal outcome

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Authors: Prem K. Mony, Bharadwaj Amrutur, Prashanth Thankachan, Swarnarekha Bhat, Suman Rao, Maryann Washington, Annamma Thomas, N. Sheela, Hiteshwar Rao, Sumi Antony

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The disease burden among mothers and newborns is caused mostly by a handful of avoidable conditions occurring around the time of childbirth and within the first month following delivery. Real-time monitoring of vital parameters of mothers and neonates offers a potential opportunity to impact access as well as the quality of care in vulnerable populations. We describe the design, development and testing of an innovative wearable device for remote biomonitoring (RBM) of body temperatures in mothers and neonates in a hospital in southern India. The architecture consists of: [1] a low-cost, wearable sensor tag; [2] a gateway device for ‘real-time’ communication link; [3] piggy-backing on a commercial GSM communication network; and [4] an algorithm-based data analytics system. Requirements for the device were: long battery-life upto 28 days (with sampling frequency 5/hr); robustness; IP 68 hermetic sealing; and human-centric design. We undertook pre-clinical laboratory testing followed by clinical trial phases I & IIa for evaluation of safety and efficacy in the following sequence: seven healthy adult volunteers; 18 healthy mothers; and three sets of babies – 3 healthy babies; 10 stable babies in the Neonatal Intensive Care Unit (NICU) and 1 baby with hypoxic ischaemic encephalopathy (HIE). The 3-coin thickness, pebble-design sensor weighing about 8 gms was secured onto the abdomen for the baby and over the upper arm for adults. In the laboratory setting, the response-time of the sensor device to attain thermal equilibrium with the surroundings was 4 minutes vis-a-vis 3 minutes observed with a precision-grade digital thermometer used as a reference standard. The accuracy was ±0.1°C of the reference standard within the temperature range of 25-40°C. The adult volunteers, aged 20 to 45 years, contributed a total of 345 hours of readings over a 7-day period and the postnatal mothers provided a total of 403 paired readings. The mean skin temperatures measured in the adults by the sensor were about 2°C lower than the axillary temperature readings (sensor =34.1 vs digital = 36.1); this difference was statistically significant (t-test=13.8; p<0.001). The healthy neonates provided a total of 39 paired readings; the mean difference in temperature was 0.13°C (sensor =36.9 vs digital = 36.7; p=0.2). The neonates in the NICU provided a total of 130 paired readings. Their mean skin temperature measured by the sensor was 0.6°C lower than that measured by the radiant warmer probe (sensor =35.9 vs warmer probe = 36.5; p < 0.001). The neonate with HIE provided a total of 25 paired readings with the mean sensor reading being not different from the radian warmer probe reading (sensor =33.5 vs warmer probe = 33.5; p=0.8). No major adverse events were noted in both the adults and neonates; four adult volunteers reported mild sweating under the device/arm band and one volunteer developed mild skin allergy. This proof-of-concept study shows that real-time monitoring of temperatures is technically feasible and that this innovation appears to be promising in terms of both safety and accuracy (with appropriate calibration) for improved maternal and neonatal health.

Keywords: public health, remote biomonitoring, temperature surveillance, wearable sensors, mothers and newborns

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Authors: Nelson Igaba, C. Onaga, S. Hlongwane

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Background: Medical Male Circumcision (MMC) is part of a comprehensive HIV prevention strategy. The quality of MMC done at Right To Care (RtC) sites is maintained by Continuous Quality Improvement (CQI) based on findings of assessments by internal and independent external assessors who evaluate such parameters as the quality of the surgical procedure, infection control, etc. There are 12 RtC MMC teams in Mpumalanga, two of which are headed by Medical Officers and 10 by Clinical Associates (Clin A). Objectives: To compare the quality (i) of care rendered at doctor headed sites (DHS) versus Clin A headed sites (CHS); (ii) of CQI assessments (external versus internal). Methodology: A retrospective review of data from RightMax™ (a novel RtC data management system) and CQI reports (external and internal) was done. CQI assessment scores of October 2015 and October 2016 were taken as the baseline and latest respectively. Four sites with 745-810 circumcisions per annum were purposively selected; the two DHS (group A) and two CHS (group B). Statistical analyses were conducted using R (2017 version). Results: There were no significant difference in latest CQI scores between the two groups (DHS and CHS) (Anova, F = 1.97, df = 1, P = 0.165); between internal and external CQI assessment scores (Anova, F = 2.251, df = 1, P = 0.139) or among the individual sites (Anova, F = 1.095, df = 2, P = 0.341). Of the total of 16 adverse events reported by the four sites in the 12 months reviewed (all were infections), there was no statistical evidence that the documented severity of the infection was different for DHS and CHS (Fisher’s exact test, p-value = 0.269). Conclusion: At RtC VMMC sites in Mpumalanga, internal and external/independent CQI assessments are comparable, and quality of care of VMMC is standardized with the performance of well-supervised clinical associates comparing well with those of medical officers.

Keywords: adverse events, Right to Care, male medical circumcision, continuous quality improvement

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Authors: Abdul Aziz, Muhammad Qamar Masood, Saadia Sattar, Saira Fatima, Najmul Islam

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Introduction: The most common endocrine tumor is thyroid cancer. Follicular Thyroid Carcinoma (FTC) accounts for 5%–10% of all thyroid cancers. Patients with FTC frequently present with more advanced stage diseases and a higher occurrence of distant metastases because of the propensity of vascular invasion. FTC is mainly treated with surgery, while radioactive iodine therapy is the main adjuvant therapy as per ATA guidelines. In many developing countries, surgical facilities and radioactive iodine are in short supply; therefore, understanding follicular thyroid cancer trends may help developing countries plan and use resources more effectively. Methodology: It was a retrospective observational study of FTC patients of age 18 years and above conducted at Aga Khan University Hospital, Karachi, from 1st January 2010 to 31st December 2019. Results: There were 404 patients with thyroid carcinoma, out of which forty (10.1%) were FTC. 50% of the patients were in the 41-60 years age group, and the female to male ratio was 1.5: 1. Twenty-four patients (60%) presented with complain of neck swelling followed by metastasis (20%) and compressive symptoms (20%). The most common site of metastasis was bone (87.5%), followed by lung (12.5%). The pre-operative thyroglobulin level was done in six out of eight metastatic patients (75%) in which it was elevated. This emphasizes the importance of checking thyroglobulin level in unusual presentation (bone pain, fractures) of a patient having neck swelling also to help in establishing the primary source of tumor. There was no complete documentation of ultrasound features of the thyroid gland in all the patients, which is an important investigation done in the initial evaluation of thyroid nodule. On FNAC, 50% (20 patients) had Bethesda category III-IV nodules, while 10% ( 4 patients ) had Bethesda category II. In sixteen patients, FNAC was not done as they presented with compressive symptoms or metastasis. Fifty percent had a total thyroidectomy and 50% had subtotal followed by completion thyroidectomy, plus ten patients had lymph node dissection, out of which seven had histopathological lymph node involvement. On histopathology, twenty-three patients (57.5%) had minimally invasive, while seventeen (42.5%) had widely invasive follicular thyroid carcinoma. The capsular invasion was present in thirty-three patients (82.5%); one patient had no capsular invasion, but there was a vascular invasion. Six patients' histopathology had no record of capsular invasion. In contrast, the lymphovascular invasion was present in twenty-six patients (65%). In this study, 65 % of the patients had clinical stage 1 disease, while 25% had stage 2 and 10% had clinical stage 4. Seventeen patients (42.5%) had received RAI 30-100 mCi, while ten patients (25%) received more than 100 mCi. Conclusion: FTC demographic and clinicopathological presentation are the same in Pakistan as compared to other countries. Surgery followed by RAI is the mainstay of treatment. Thus understanding the trend of FTC and proper planning and utilization of the resources will help the developing countries in effectively treating the FTC.

Keywords: thyroid carcinoma, follicular thyroid carcinoma, clinicopathological features, developing countries

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Authors: Mya Achike

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Background and Significance: Perinatal mental illness covers a wide range of conditions and has a huge influence on maternal-child health. Issues and challenges with perinatal mental health have been associated with poor pregnancy, birth, and postpartum outcomes. It is estimated that one out of five new and expectant mothers experience some degree of perinatal mental illness, which makes this a hugely significant health outcome. Certain factors increase the maternal risk for mental illness. Challenges related to poverty, migration, extreme stress, exposure to violence, emergency and conflict situations, natural disasters, and pandemics can exacerbate mental health disorders. It is widely expected that perinatal mental health is being negatively affected during the present COVID-19 pandemic. Methods: A review of studies that reported a measurement tool to assess perinatal mental health outcomes during the COVID-19 pandemic was conducted following PRISMA (Preferred Reporting Items for Systematic Reviews and Meta-Analyses) guidelines. PubMed, CINAHL, and Google Scholar were used to search for peer-reviewed studies published after late 2019, in accordance with the emergence of the virus. The search resulted in the inclusion of ten studies. Approach to measure health outcome: The main approach to measure perinatal mental illness is the use of self-administered, validated questionnaires, usually in the clinical setting. Summary: Widespread use of these tools has afforded the clinical and research communities the ability to identify and support women who may be suffering from mental illness disorders during a pandemic. More research is needed to validate tools in other vulnerable, perinatal populations.

Keywords: mental health during covid, perinatal mental health, perinatal mental health measurement tools, perinatal mental health tools

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Authors: Frank Dorrian, Aniket Adhikari

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The placenta accreta spectrum (PAS), which includes placenta accreta, increta, and percreta, is characterized by the abnormal implantation of placental chorionic villi beyond the decidua basalis. Key risk factors include placenta previa, prior cesarean sections, advanced maternal age, uterine surgeries, multiparity, pelvic radiation, and in vitro fertilization (IVF). The incidence of PAS has increased tenfold over the past 50 years, largely due to rising cesarean rates. PAS is associated with significant peripartum and postpartum hemorrhage. Magnetic resonance imaging (MRI) and ultrasound assist in the evaluation of PAS, enabling a multidisciplinary approach to mitigate morbidity and mortality. This study retrospectively analyzed PAS cases at Royal Prince Alfred Hospital, Sydney, Australia. Using the SAR-ESUR joint consensus statement, seven imaging signs were reassessed for their sensitivity and specificity in predicting PAS, with histopathological correlation. The standardized MRI protocols for PAS at the institution were also reviewed. Data were collected from the picture archiving and communication system (PACS) records from 2010 to July 2024, focusing on cases where MR imaging and confirmed histopathology or operative notes were available. This single-center, observational study provides insights into the reliability of MRI for PAS detection and the optimization of imaging protocols for accurate diagnosis. The findings demonstrate that intraplacental dark bands serve as highly sensitive markers for diagnosing PAS, achieving sensitivities of 88.9%, 85.7%, and 100% for placenta accreta, increta, and percreta, respectively, with a combined specificity of 42.9%. Sensitivity for abnormal vascularization was lower (33.3%, 28.6%, and 50%), with a specificity of 57.1%. The placenta bulge exhibited sensitivities of 55.5%, 57.1%, and 100%, with a specificity of 57.1%. Loss of the T2 hypointense interface had sensitivities of 66.6%, 85.7%, and 100%, with 42.9% specificity. Myometrial thinning showed high sensitivity across PAS conditions (88.9%, 71.4%, and 100%) and a specificity of 57.1%. Bladder wall thinning was sensitive only for placenta percreta (50%) but had a specificity of 100%. Focal exophytic mass displayed variable sensitivity (22.9%, 42.9%, and 100%) with a specificity of 85.7%. These results highlight the diagnostic variability among markers, with intraplacental dark bands and myometrial thinning being useful in detecting abnormal placentation, though they lack high specificity. The literature and the results of our study highlight that while no single feature can definitively diagnose PAS, the presence of multiple features -especially when combined with elevated clinical risk- significantly increases the likelihood of an underlying PAS. A thorough understanding of the range of MRI findings associated with PAS, along with awareness of the clinical significance of each sign, helps the radiologist more accurately diagnose the condition and assist in surgical planning, ultimately improving patient care.

Keywords: placenta, accreta, spectrum, MRI

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Authors: Sat Sharma, Antonella Conflitti, Hilary Reiter

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Introduction: The study's purpose was to assess the efficacy of the oral appliance device O2Vent Optima + ExVent as compared to Optima in the treatment of OSA. Methods: A prospective, open-label study conducted at 3 sites included subjects with mild to moderate OSA (AHI ≥ 5 and ≤ 30). Screening Phase: A diagnostic in-lab PSG study was performed to confirm a diagnosis of mild to moderate OSA. Treatment I: Subjects used O2Vent Optima for 6 weeks and underwent an in-lab PSG sleep night while using the O2Vent Optima. Treatment II: Subjects used O2Vent Optima + ExVent for 6 weeks and underwent an in-lab PSG sleep night while using the O2Vent Optima + ExVent Primary Effectiveness Measure: Change in AHI between baseline vs. O2Vent Optima MAD vs. O2Vent Optima + ExVent. Results: Treatment with Optima, Optima + ExVent reduced AHI from 22.5±6.4/hr to 12.6±4.5/hr to 5.9±2.7 (p< 0.005 baseline vs. Optima and Optima + ExVent; p<0.05 Optima MAD vs. Optima + ExVent). The average reduction in AHI with Optima was 43%, and with Optima + ExVent was 72%. The lowest oxygen during sleep increased from 84.6±2.7% to 88.6±2.9% to 91.6±3.2% (p< 0.005 baseline vs. Optima and Optima + ExVent; p<0.05 Optima vs. Optima + ExVent). During the trial, patients on treatment with Optima and Optima + ExVent demonstrated no excessive adverse events or device malfunction. Conclusion: Treatment with O2Vent Optima and O2Vent Optima + ExVent significantly improved OSA compared to the baseline. An even greater benefit was observed with the addition of ExVent to the Optima in mild to moderate OSA.

Keywords: oral appliance, O2Vent, sleep dentistry, sleep apnea

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Authors: Weldegerima Gebremedhin Hagos

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Background: The Coronavirus disease of 2019 (COVID-19) is a catastrophic emerging global health threat caused by the severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2). COVID-19 has a wide range of complications and sequels. It is devastating in developing countries, causing serious health and socioeconomic crises as a result of the increasingly overburdened healthcare system. Ethiopia reported the first case of SARS-CoV-2 on 13th March 2020, with community transmission ensuing by mid-May. The aim of this study was conducted to determine the prevalence of SARS-CoV-2 infection in Tigray, Ethiopia. Methods: Facility-based correctional study designs were used on a total of 380 study participants from March 2023 up to May 2023 in two general hospitals and one comprehensive specialized hospital in Tigray, Ethiopia. A pre-structured questionnaire was used to assess information regarding the socio-demographic, clinical data and other risk factors. A nasal swap was taken by trained health professionals, and the laboratory analysis was done by RT-PCR (quant studio 7-flex, applied biosystems) in Tigrai Health Research Institute and Mekelle University Medical Microbiology Research Laboratory. Result: The mean age of the study participants was 31 (SD+/-3.5) years, with 65% being male and 35% female. The overall seropositivity of sars-cov-2 among the study participants was 5.5%. The prevalence was higher in males (6.2%) than females which were (4.7%). Sars-cov-2 infection was significantly associated with a history of lack of vaccination (p-value 0.002). There was no significant association between seropositivity and demographic factors (P > 0.05). Conclusion: The seroprevalence of SARS-CoV-2 among the study participants is high. Those study participants with a previous history of vaccination have a low probability of developing COVID-19 infection. A low SARS-CoV-2 infection rate was recorded in those who frequently use masks.

Keywords: prevalence, SARS-CoV-2, infection, risk factors

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Authors: Mangala M. Pai, B. V. Murlimanju, Latha V. Prabhu, P. J. Jiji , Vandana Blossom

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Background:To study the morphological parameters of the axis vertebra in anatomical specimens. Methods: The present study was designed to obtain the morphometric data of axis vertebra. The superior and inferior articular facets of the axis were macroscopically observed for their shapes and the different parameters were measured using the digital Vernier caliper. It included 20 dried axis bones, which were obtained from the anatomy laboratory. Results: The morphometric data obtained in the present study are represented in the tables. The side wise comparison of the length and width of the articular facets of the axis vertebra were done. The present study observed that, there is no statistically significant difference observed among the parameters of right and left side articular facets (p>0.05). The superior and inferior articular facets were observed to have variable shapes. The frequencies of different shapes of superior and inferior articular facets are represented in figures. All the shapes of the inferior and superior articular facets were symmetrical over the right and left sides. Among the superior articular facets, the constrictions were absent in 13 cases (65%), 2 (10%) exhibited a single constriction, 3 (15%) had 2 constrictions and 2 (10%) were having 3 constrictions. The constrictions were absent in 11 (55%) of the inferior articular facets, 3 (15%) of them had 1 constriction, 3 (15%) were having 2 constrictions, 2 (10%) exhibited 3 constrictions and 1 (5%) of them had 4 constrictions. The constrictions of the inferior and superior articular facets were symmetrical over the right and left sides. Conclusion: We believe that the present study has provided additional information on the morphometric data of the axis vertebra. The data are important to the neurosurgeons, orthopedic surgeons and radiologists. The preoperative assessment of the axis vertebra may prevent dangerous complications like spinal cord and nerve root compression during the surgical intervention.

Keywords: axis, articular facet, morphology, morphometry

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Authors: Gorazd Karer

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When performing a diagnostic procedure or surgery in general anesthesia (GA), a proper introduction and dosing of anesthetic agents are one of the main tasks of the anesthesiologist. However, depth of anesthesia (DoA) also seems to be a suitable process for closed-loop control implementation. To implement such a system, one must be able to acquire the relevant signals online and in real-time, as well as stream the calculated control signal to the infusion pump. However, during a procedure, patient monitors and infusion pumps are purposely unable to connect to an external (possibly medically unapproved) device for safety reasons, thus preventing closed-loop control. The paper proposes a conceptual solution to the aforementioned problem. First, it presents some important aspects of contemporary clinical practice. Next, it introduces the closed-loop-control-system structure and the relevant information flow. Focusing on transferring the data from the patient to the computer, it presents a non-invasive image-based system for signal acquisition from a patient monitor for online depth-of-anesthesia assessment. Furthermore, it introduces a UDP-based communication method that can be used for transmitting the calculated anesthetic inflow to the infusion pump. The proposed system is independent of a medical device manufacturer and is implemented in Matlab-Simulink, which can be conveniently used for DoA control implementation. The proposed scheme has been tested in a simulated GA setting and is ready to be evaluated in an operating theatre. However, the proposed system is only a step towards a proper closed-loop control system for DoA, which could routinely be used in clinical practice.

Keywords: closed-loop control, depth of anesthesia (DoA), modeling, optical signal acquisition, patient state index (PSi), UDP communication protocol

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Authors: Faith-Michael E. Uzoka, Boluwaji A. Akinnuwesi, Taiwo Amoo, Flora Aladi, Stephen Fashoto, Moses Olaniyan, Joseph Osuji

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The overarching aim of this study is to develop a soft-computing system for the differential diagnosis of tropical diseases. These conditions are of concern to health bodies, physicians, and the community at large because of their mortality rates, and difficulties in early diagnosis due to the fact that they present with symptoms that overlap, and thus become ‘confusable’. We report on the first phase of our study, which focuses on the development of a fuzzy cognitive map model for early differential diagnosis of tropical diseases. We used malaria as a case disease to show the effectiveness of the FCM technology as an aid to the medical practitioner in the diagnosis of tropical diseases. Our model takes cognizance of manifested symptoms and other non-clinical factors that could contribute to symptoms manifestations. Our model showed 85% accuracy in diagnosis, as against the physicians’ initial hypothesis, which stood at 55% accuracy. It is expected that the next stage of our study will provide a multi-disease, multi-symptom model that also improves efficiency by utilizing a decision support filter that works on an algorithm, which mimics the physician’s diagnosis process.

Keywords: medical diagnosis, tropical diseases, fuzzy cognitive map, decision support filters, malaria differential diagnosis

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Authors: Farnaz Dehkhoda

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This study was conducted to compare the effectiveness of active and receptive music-therapy on anxiety in cancer patients undergoing chemotherapy or radiotherapy. 184 young adult patients, who were diagnosed with early stage cancer and were undergoing treatment, were divided into three groups. Two groups received music therapy as a parallel treatment and the third group was control group. In active music-therapy, a music specialist helped the patients to play guitar and sing. In the receptive music-therapy, patients preferred pre-recorded music played by MP3 player. The level of anxiety was measured by the Beck Anxiety Inventory as pre-test and post-test. ANCOVA revealed that both types of music-therapy reduced anxiety level of patients and the active music-therapy intervention found to be more effective. The results suggest that music-therapy can be applied as an intervention method contemporary with cancer medical treatment, for improving quality of life in cancer patients by reducing their anxiety.

Keywords: Anxiety, Cancer, Chemotherapy, Music-therapy

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Authors: Allaire Eric, Hauet Pascal, Floresco Jean, Beley Sebastien, Sussman Helene, Virag Ronald

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Background: Caverno-venous leakage (CVL) is devastating, although barely known disease, the first cause of major physical impairment in men under 25, and responsible for 50% of resistances to phosphodiesterase 5-inhibitors (PDE5-I), affecting 30 to 40% of users in this medication class. In this condition, too early blood drainage from corpora cavernosa prevents penile rigidity and penetration during sexual intercourse. The role of conservative surgery in this disease remains controversial. Aim: Assess complications and results of combined open surgery and embolization for CVL. Method: Between June 2016 and September 2021, 133 consecutive patients underwent surgery in our institution for CVL, causing severe erectile dysfunction (ED) resistance to oral medical treatment. Procedures combined vein embolization and ligation with microsurgical techniques. We performed a pre-and post-operative clinical (Erection Harness Scale: EHS) hemodynamic evaluation by duplex sonography in all patients. Before surgery, the CVL network was visualized by computed tomography cavernography. Penile EMG was performed in case of diabetes or suspected other neurological conditions. All patients were optimized for hormonal status—data we prospectively recorded. Results: Clinical signs suggesting CVL were ED since age lower than 25, loss of erection when changing position, penile rigidity varying according to the position. Main complications were minor pulmonary embolism in 2 patients, one after airline travel, one with Factor V Leiden heterozygote mutation, one infection and three hematomas requiring reoperation, one decreased gland sensitivity lasting for more than one year. Mean pre-operative pharmacologic EHS was 2.37+/-0.64, mean pharmacologic post-operative EHS was 3.21+/-0.60, p<0.0001 (paired t-test). The mean EHS variation was 0.87+/-0.74. After surgery, 81.5% of patients had a pharmacologic EHS equal to or over 3, allowing for intercourse with penetration. Three patients (2.2%) experienced lower post-operative EHS. The main cause of failure was leakage from the deep dorsal aspect of the corpus cavernosa. In a 14 months follow-up, 83.2% of patients had a clinical EHS equal to or over 3, allowing for sexual intercourse with penetration, one-third of them without any medication. 5 patients had a penile implant after unsuccessful conservative surgery. Conclusion: Open surgery combined with embolization for CVL is an efficient approach to CVL causing severe erectile dysfunction.

Keywords: erectile dysfunction, cavernovenous leakage, surgery, embolization, treatment, result, complications, penile duplex sonography

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Authors: Mekroud Amel

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Emergency departments are known for the workload, the variety of pathologies and the difficulties in their management with the continuous influx of patients The role of our service in the management of patients with two or three mild to moderate organ failures, involving several disciplines at the same time, as well as the effect of this management on the skills and efficiency of our team has been demonstrated Borderline cases between two or three or even more disciplines, with instability of a vital function, which have been successfully managed in the emergency room, the therapeutic procedures adopted, the consequences on the quality and level of care delivered by our team, as well as that the logistical consequences, and the pedagogical consequences are demonstrated. The consequences found are Positive on the emergency teams, in rare situations are negative Regarding clinical situations, it is the entanglement of hemodynamic distress with right, left or global participation, tamponade, low flow with acute pulmonary edema, and/or state of shock With respiratory distress with more or less profound hypoxemia, with haematosis disorder related to a bacterial or viral lung infection, pleurisy, pneumothorax, bronchoconstrictive crisis. With neurological disorders such as recent stroke, comatose state, or others With metabolic disorders such as hyperkalaemia renal insufficiency severe ionic disorders with accidents with anti vitamin K With or without septate effusion of one or more serous membranes with or without tamponade It’s a Retrospective, monocentric, descriptive study Period 05.01.2022 to 10.31.2022 the purpose of our work: Search for a statistically significant link between the type of moderate to severe pathology managed in the emergency room whose problems are multivisceral on the efficiency of the healthcare team and its level of care and optional care offered for patients Statistical Test used: Chi2 test to prove the significant link between the resolution of serious multidisciplinary cases in the emergency room and the effectiveness of the team in the management of complicated cases Search for a statistically significant link : The management of the most difficult clinical cases for organ specialties has given general practitioner emergency teams a great perspective and has been able to improve their efficiency in the face of emergencies received

Keywords: emergency care teams, management of patients with dysfunction of more than one organ, learning curve, quality of care

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Authors: R. Janyaphadungpong, A. Pimkhaokham

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This prospective clinical study determined the insertion torque (IT) value and monitored the changes in implant stability quotient (ISQ) values during the 12 weeks healing period from implant placement without bone graft (control group) and with bone graft using the guided bone regeneration (GBR) technique (study group). The relationship between the IT and ISQ values of the implants was also assessed. The control and study groups each consisted of 6 patients with 8 implants per group. The ASTRA TECH Implant System™ EV 4.2 mm in diameter was placed in the posterior mandibular region. In the control group, implants were placed in bone without bone graft, whereas in the study group implants were placed simultaneously with the GBR technique at favorable bone defect. IT (Ncm) of each implant was recorded when fully inserted. ISQ values were obtained from the Osstell® ISQ at the time of implant placement, and at 2, 4, 8, and 12 weeks. No difference in IT was found between groups (P = 0.320). The ISQ values in the control group were significantly higher than in the study group at the time of implant placement and at 4 weeks. There was no significant association between IT and ISQ values either at baseline or after the 12 weeks. At 12 weeks of healing, the control and study groups displayed different trends. Mean ISQ values for the control group decreased over the first 2 weeks and then started to increase. ISQ value increases were statistically significant at 8 weeks and later, whereas mean ISQ values in the study group decreased over the first 4 weeks and then started to increase, with statistical significance after 12 weeks. At 12 weeks, all implants achieved osseointegration with mean ISQ values over the threshold value (ISQ>70). These results indicated that implants, in which guided bone regeneration technique was performed during implant placement for treating favorable bone defects, were as predictable as implants placed without bone graft. However, loading in implants placed with the GBR technique for correcting favorable bone defects should be performed after 12 weeks of healing to ensure implant stability and osseointegration.

Keywords: dental implant, favorable bone defect, guided bone regeneration technique, implant stability

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Authors: Gabriela Silva-Maceda, Silvia Romero-Contreras

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Spanish is a more transparent language than English given that it has more direct correspondences between sounds and letters. It has become important to understand how decoding and linguistic comprehension contribute to reading comprehension in the framework of the widely known Simple View Model. This study aimed to identify the level of prediction by these two components in a sample of 1st to 4th grade children attending two schools in central Mexico (one public and one private). Within each school, ten children were randomly selected in each grade level, and their parents were asked about reading habits and socioeconomic information. In total, 79 children completed three standardized tests measuring decoding (pseudo-word reading), linguistic comprehension (understanding of paragraphs) and reading comprehension using subtests from the Clinical Evaluation of Language Fundamentals-Spanish, Fourth Edition, and the Test de Lectura y Escritura en Español (LEE). The data were analyzed using hierarchical regression, with decoding as a first step and linguistic comprehension as a second step. Results showed that decoding accounted for 19.2% of the variance in reading comprehension, while linguistic comprehension accounted for an additional 10%, adding up to 29.2% of variance explained: F (2, 75)= 15.45, p <.001. Socioeconomic status derived from parental questionnaires showed a statistically significant association with the type of school attended, X2 (3, N= 79) = 14.33, p =.002. Nonetheless when analyzing the Simple View components, only decoding differences were statistically significant (t = -6.92, df = 76.81, p < .001, two-tailed); reading comprehension differences were also significant (t = -3.44, df = 76, p = .001, two-tailed). When socioeconomic status was included in the model, it predicted a 5.9% unique variance, even when already accounting for Simple View components, adding to a 35.1% total variance explained. This three-predictor model was also significant: F (3, 72)= 12.99, p <.001. In addition, socioeconomic status was significantly correlated with the amount of non-textbook books parents reported to have at home for both adults (rho = .61, p<.001) and children (rho= .47, p<.001). Results converge with a large body of literature finding socioeconomic differences in reading comprehension; in addition this study suggests that these differences were also present in decoding skills. Although linguistic comprehension differences between schools were expected, it is argued that the test used to collect this variable was not sensitive to linguistic differences, since it came from a test to diagnose clinical language disabilities. Even with this caveat, results show that the components of the Simple View Model can predict less than a third of the variance in reading comprehension in Spanish. However, the results also suggest that a fuller model of reading comprehension is obtained when considering the family’s socioeconomic status, given the potential differences shown by the socioeconomic status association with books at home, factors that are particularly important in countries where inequality gaps are relatively large.

Keywords: decoding, linguistic comprehension, reading comprehension, simple view model, socioeconomic status, Spanish

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Authors: Jacqueline Y. Thompson, Sam Watson, Lee Middleton, Karla Hemming

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Introduction: The odds ratio (estimated via logistic regression) is a well-established and common approach for estimating covariate-adjusted binary treatment effects when comparing a treatment and control group with dichotomous outcomes. Its popularity is primarily because of its stability and robustness to model misspecification. However, the situation is different for the relative risk and risk difference, which are arguably easier to interpret and better suited to specific designs such as non-inferiority studies. So far, there is no equivalent, widely acceptable approach to estimate an adjusted relative risk and risk difference when conducting clinical trials. This is partly due to the lack of a comprehensive evaluation of available candidate methods. Methods/Approach: A simulation study is designed to evaluate the performance of relevant candidate methods to estimate relative risks to represent conditional and marginal estimation approaches. We consider the log-binomial, generalised linear models (GLM) with iteratively weighted least-squares (IWLS) and model-based standard errors (SE); log-binomial GLM with convex optimisation and model-based SEs; log-binomial GLM with convex optimisation and permutation tests; modified-Poisson GLM IWLS and robust SEs; log-binomial generalised estimation equations (GEE) and robust SEs; marginal standardisation and delta method SEs; and marginal standardisation and permutation test SEs. Independent and identically distributed datasets are simulated from a randomised controlled trial to evaluate these candidate methods. Simulations are replicated 10000 times for each scenario across all possible combinations of sample sizes (200, 1000, and 5000), outcomes (10%, 50%, and 80%), and covariates (ranging from -0.05 to 0.7) representing weak, moderate or strong relationships. Treatment effects (ranging from 0, -0.5, 1; on the log-scale) will consider null (H0) and alternative (H1) hypotheses to evaluate coverage and power in realistic scenarios. Performance measures (bias, mean square error (MSE), relative efficiency, and convergence rates) are evaluated across scenarios covering a range of sample sizes, event rates, covariate prognostic strength, and model misspecifications. Potential Results, Relevance & Impact: There are several methods for estimating unadjusted and adjusted relative risks. However, it is unclear which method(s) is the most efficient, preserves type-I error rate, is robust to model misspecification, or is the most powerful when adjusting for non-prognostic and prognostic covariates. GEE estimations may be biased when the outcome distributions are not from marginal binary data. Also, it seems that marginal standardisation and convex optimisation may perform better than GLM IWLS log-binomial.

Keywords: binary outcomes, statistical methods, clinical trials, simulation study

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Authors: Kamesh Gupta, Nitin Jain, Anurag Rohatgi

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Objective: To study Vitamin B12 levels and presence of peripheral neuropathy among diabetes mellitus patients on metformin therapy. Method: The observational study was conducted from November 2014 to March 2015. Patients were selected from the Lady Hardinge Medical College, Delhi, India. Exhaustive history regarding dietary habits and metformin usage was taken. Lab tests including HbA1c levels and Vit B12 assays were done, on the basis of which patients were classified into subgroups. Peripheral neuropathy was detected by both clinical scoring and electrophysiological studies. Appropriate Statistical analysis for observational studies was done to evaluate the data. Results: The average duration of metformin usage was higher in patients with definite B12 deficiency (9.4y) than patients with normal B12 levels (5.6 y). Patients in the definite B12 deficiency group had much higher incidence of neuropathy (89%) than patients with no deficiency (27%). The incidence of neuropathy was higher in cases with longer metformin usage (100% with 18-22y of use and 83% with 14-17y of use) than shorter periods (29% with 2-5y of use and 75% with 6-9y of use). Conclusion: Thus patients on long-term metformin therapy are at a high risk for Vitamin B12 deficiency. Definite and possible Vitamin B12 deficiency on metformin had an earlier onset of neuropathy than the subgroup with normal Vitamin B12 levels.

Keywords: diabetic neuroptahy, cobalamine deficiency, metformin, nerve conduction studies

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Authors: Seok Woo Chang, Kee Yeon Kum, Kwang Shik Bae, WooCheol Lee

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Aim: The objective of this study was to compare the biocompatibilities and mineralization potential of ProRoot MTA and newly developed calcium phosphate based cement, Capseal. Materials and Methods: The biocompatibilities and mineralization-related gene expressions (Bone sialoprotein (BSP) and osteocalcin (OCN)) of ProRoot MTA and Capseal were also compared by a methylthiazol tetrazolium (MTT) assay and reverse transcription-polymerization chain reaction (RT-PCR) analysis on 1, 3, and 7 days, respectively. Empty rings were used as control group. The results were statistically analyzed by Kruskal-Wallis test with a Bonferroni correction. P-value of < 0.05 was considered significant. Results: The biocompatibilities of ProRoot MTA and Capseal were equally favorable. ProRoot MTA and Capseal affected the messenger RNA expression of osteocalcin and osteonectin. Conclusions: Based on the results, both ProRoot MTA and Capseal could be a useful biomaterial in clinical endodontics.

Keywords: biocompatibility, calcium silicate cement, MTT, RT-PCR

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