Search results for: clinical outcome

Authors: Uma Krishnamoorthy, Vivienne Beavers, Janet Marshall

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Introduction: Cervical cytology showing features raising the suspicion of non cervical glandular neoplasia are reported as code 0 under the United Kingdom National Health Service Cervical screening programme ( NHSCSP). As the suspicion is regarding non cervical neoplasia, smear is reported as normal and patient informed that cervical screening result is normal. GP receives copy of results where it states further referral is indicated in small font within text of report. Background: There were several incidents of delayed diagnosis of endometrial cancer in Lancashire which prompted this Northwest Regional review to enable an understanding of underlying pathology outcome of code zero smears to raise awareness and also to review whether further action on wording of smear results was indicated to prevent such delay. Methodology: All Smears reported at the Manchester cytology centre who process cytology for Lancashire population from March 2013 to March 2014 were reviewed and histological diagnosis outcome of women in whom smear was reported as code zero was reviewed retrospectively . Results: Total smears reported by the cytology centre during this period was approximately 109400. Reports issued with result code 0 among this during this time period was 49.Results revealed that among three fourth (37) of women with code zero smear (N=49), evidence of underlying pathology of non cervical origin was confirmed. Of this, 73 % (36) were due to endometrial pathology with 49 % (24) endometrial carcinoma, 12 % (6)polyp, 4 % atypical endometrial hyperplasia (2), 6 % endometrial hyperplasia without atypia (3), and 2 % adenomyosis (1 case) and 2 % ( 1 case) due to ovarian adenocarcinoma. Conclusion: This review demonstrated that more than half (51 %) of women with a code 0 smear report were diagnosed with underlying carcinoma and 75 % had a confirmed underlying pathology contributory to code 0 smear findings. Recommendations and Action Plan: A local rapid access referral and management pathway for this group of women was implemented as a result of this in our unit. The findings and Pathway were shared with other regional units served by the cytology centre through the Pan Lancashire cervical screening board and through the Cytology centre. Locally, the smear report wording was updated to include a rubber stamp/ print in "Red Bold letters" stating that " URGENT REFERRAL TO GYNAECOLOGY IS INDICATED". Findings were also shared through the Pan Lancashire board with National cervical screening programme board, and revisions to wording of code zero smear reports to highlight the need for Urgent referral has now been agreed at National level to be implemented.

Keywords: code zero smears, endometrial cancer, non cervical glandular neoplasia, ovarian cancer

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Authors: Marzieh Yassin, Masoud Rashed, Soheil Mansour Sohani, Reza Salehi

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Background: Hip arthroplasty is one of the surgical methods to improve symptoms in patients with hip osteoarthritis. The use of electroacupuncture and TENS reduces pain, increases range of motion and improves performance. Methods: In this clinical trial study, 30 patients after hip arthroplasty were randomly divided into two groups: electroacupuncture (n=16) with exercise therapy and TENS with exercise therapy (n=14). Severity of pain, quality of life, range of motion, edema and function were evaluated in two groups before and after the interventions. Interventions of 10 sessions (three sessions per week) were conducted for two groups. The significance level in all tests was below 0.05. Results: The results showed that both groups improved all of the symptoms after the intervention (p≤0.05), although there was no statistically significant difference between the two groups in terms of effectiveness (p≥0.05). Conclusion: The results showed that both methods improve symptoms in patients after surgery. According to this study, electroacupuncture is suggested as a new method effective for the treatment of people with post-Total Hip Arthroplasty.

Keywords: electroacupuncture, physical performance, total hip arthroplasty, TENS

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Authors: Nita Nurlaila Kadarwaty

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Purpose: This study presents a rare case of bilateral Acute Primary Angle Closure Glaucoma (PACG). Method: A case report of a 64-year-old woman with a good outcome Acute PACG in both eyes who underwent phacotrabeculectomy surgery. Result: A 64-year-old woman complained of acute pain in both eyes, accompanied by decreased vision, photophobia, and seeing halos for three weeks. There was no history of trauma, steroid or other systemic drugs used, or intraocular surgery before. Ophthalmologic examination revealed a right eye (RE) visual acuity of 0.1, left eye (LE) 0.2. RE intraocular pressure (IOP) was 12 mmhg and LE: 36.4 mmHg in medication of timolol maleat ED and acetazolamide oral. Both eyes' anterior segments revealed mixed injection, corneal edema, shallow anterior chamber, posterior synechiae, mid-dilatation pupil with negative pupillary reflection, and cloudy lens without intumescent. There was a glaucomatous optic and closed iridocorneal angle on the gonioscopy. Initial treatments included oral acetazolamide and potassium aspartate 250 mg three times a day, timolol maleate ED 0.5% twice a day, and prednisolone acetate ED 1% four times a day. This patient underwent trabeculectomy, phacoemulsification, and implantation of IOL in both eyes. One week after the surgeries, both eyes showed decreased IOP and good visual improvement. Conclusion: Bilateral simultaneous Acute PACG is generally severe and results in a poor outcome. It causes rapidly progressive visual loss and is often irreversible. Phacotrabeculectomy has more benefits compared to only phacoemulsification for the intervention regarding the reduced IOP post-surgical.

Keywords: acute primary angle closure glaucoma, intraocular pressure, phacotrabeculectomy, glaucoma

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Authors: Vijay Kumar Singh, Pooja Kushwaha, Prabhat Ranjan, Krishna Kumar Ojha, Jitendra Kumar

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Present day high-throughput genomic technologies, NGS/microarrays, are producing large volume of data that require improved analysis methods to make sense of the data. The correlation between genes and samples has been regularly used to gain insight into many biological phenomena including, but not limited to, co-expression/co-regulation, gene regulatory networks, clustering and pattern identification. However, presence of outliers and violation of assumptions underlying Pearson correlation is frequent and may distort the actual correlation between the genes and lead to spurious conclusions. Here, we report a method to measure the strength of association between genes. The method assumes that the expression values of a gene are Bernoulli random variables whose outcome depends on the sample being probed. The method considers the two genes as uncorrelated if the number of sample with same outcome for both the genes (Ns) is equal to certainly expected number (Es). The extent of correlation depends on how far Ns can deviate from the Es. The method does not assume normality for the parent population, fairly unaffected by the presence of outliers, can be applied to qualitative data and it uses the binomial distribution to assess the significance of association. At this stage, we would not claim about the superiority of the method over other existing correlation methods, but our method could be another way of calculating correlation in addition to existing methods. The method uses binomial distribution, which has not been used until yet, to assess the significance of association between two variables. We are evaluating the performance of our method on NGS/microarray data, which is noisy and pierce by the outliers, to see if our method can differentiate between spurious and actual correlation. While working with the method, it has not escaped our notice that the method could also be generalized to measure the association of more than two variables which has been proven difficult with the existing methods.

Keywords: binomial distribution, correlation, microarray, outliers, transcriptome

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Authors: Fergus Wade, Jasmine Makker, Matthew Jankinson, Aminah Qamar, Gemma Morrelli, Shayan Shah

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Background: Ambulance offload delays (AODs) affect patient outcomes. At baseline, the average AOD at Princess Royal University Hospital (PRUH) was 41 minutes, in breach of the 15-minute target. Aims: By February 2023, we aimed to reduce: the average AOD to 30 minutes percentage of AOD >30 minutes (PA30) to 25% and >60 minutes (PA60) to 10% Methods: Following a root-cause analysis, we implemented 2 Plan, Do, Study, Act (PDSA) cycles. PDSA-1 ‘Drop-and-run’: ambulances waiting >15 minutes for a handover left the patients in the Emergency Department (ED) and returned to the community. PDSA-2: Booking in the patients before the handover, allowing direct updates to online records, eliminating the need for handwritten notes. Outcome measures: AOD, PA30, and PA60, and process measures: total ambulances and patients in the ED were recorded for 16 weeks. Results: In PDSA-1, all parameters increased slightly despite unvarying ED crowding. In PDSA-2, two shifts in data were seen: initially, a sharp increase in the outcome measures consistent with increased ED crowding, followed by a downward shift when crowding returned to baseline (p<0.01). Within this interval, the AOD reduced to 29.9 minutes, and PA30 and PA60 were 31.2% and 9.2% respectively. Discussion/conclusion: PDSA-1 didn’t result in any significant changes; lack of compliance was a key cause. The initial upward shift in PDSA-2 is likely associated with NHS staff strikes. However, during the second interval, the AOD and the PA60 met our targets of 30 minutes and 10%, respectively, improving patient flow in the ED. This was sustained without further input and if maintained, saves 2 paramedic shifts every 3 days.

Keywords: ambulance offload, district general hospital, handover, quality improvement

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Authors: Mahkameh Asadi, Habibollah Dadgar

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The precise definition margin of high and low-grade glioma is crucial for choosing best treatment approach after surgery and radio-chemotherapy. The aim of the current study was to assess the O-(2-18F-fluoroethyl)-L-tyrosine (18F-FET) positron emission tomography (PET)/computed tomography (CT) in patients with low (LGG) and high grade glioma (HGG). We retrospectively analyzed 18F-FET PET/CT of 10 patients (age: 33 ± 12 years) with suspicious for recurrent LGG and HGG. The final decision of recurrence was made by magnetic resonance imaging (MRI) and registered clinical data. While response to radio-chemotherapy by MRI is often complex and sophisticated due to the edema, necrosis, and inflammation, emerging amino acid PET leading to better interpretations with more specifically differentiate true tumor boundaries from equivocal lesions. Therefore, integrating amino acid PET in the management of glioma to complement MRI will significantly improve early therapy response assessment, treatment planning, and clinical trial design.

Keywords: positron emission tomography, amino acid positron emission tomography, magnetic resonance imaging, low and high grade glioma

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Authors: Brogan Guest, Amy Donaldson-Perrott

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The Master’s of Physician Associate Studies (MPAS) programme at St George’s, University of London (SGUL), is an intensive two-year course that trains students to become physician associates (PAs). PAs are generalized healthcare providers who work in primary and secondary care across the UK. PA programmes face the difficult task of preparing students to become safe medical providers in two short years. Our goal is to teach students to develop clinical reasoning early on in their studies and historically, this has been done predominantly though problem-based learning (PBL). We have had an increase concern about student engagement in PBL and difficulty recruiting facilitators to maintain the low student to facilitator ratio required in PBL. To address this issue, we created ‘Clinical Application of Anatomy and Physiology (CAAP)’. These peer-led, interactive, problem-based, small group sessions were designed to facilitate students’ clinical reasoning skills. The sessions were designed using the concept of Team-Based Learning (TBL). Students were divided into small groups and each completed a pre-session quiz consisting of difficult questions devised to assess students’ application of medical knowledge. The quiz was completed in small groups and they were not permitted access of external resources. After the quiz, students worked through a series of openended, clinical tasks using all available resources. They worked at their own pace and the session was peer-led, rather than facilitator-driven. For a group of 35 students, there were two facilitators who observed the sessions. The sessions utilised an infinite space whiteboard software. Each group member was encouraged to actively participate and work together to complete the 15-20 tasks. The session ran for 2 hours and concluded with a post-session quiz, identical to the pre-session quiz. We obtained subjective feedback from students on their experience with CAAP and evaluated the objective benefit of the sessions through the quiz results. Qualitative feedback from students was generally positive with students feeling the sessions increased engagement, clinical understanding, and confidence. They found the small group aspect beneficial and the technology easy to use and intuitive. They also liked the benefit of building a resource for their future revision, something unique to CAAP compared to PBL, which out students participate in weekly. Preliminary quiz results showed improvement from pre- and post- session; however, further statistical analysis will occur once all sessions are complete (final session to run December 2022) to determine significance. As a post-graduate healthcare professional programme, we have a strong focus on self-directed learning. Whilst PBL has been a mainstay in our curriculum since its inception, there are limitations and concerns about its future in view of student engagement and facilitator availability. Whilst CAAP is not TBL, it draws on the benefits of peer-led, small group work with pre- and post- team-based quizzes. The pilot of these sessions has shown that students are engaged by CAAP, and they can make significant progress in clinical reasoning in a short amount of time. This can be achieved with a high student to facilitator ratio.

Keywords: problem based learning, team based learning, active learning, peer-to-peer teaching, engagement

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Authors: Vijay Samuel, Tina Thekkekkara, Shoma Ganguly

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There is no reported Hanta Seoul virus infection in children in the UK so far, making it quite challenging for clinicians in diagnosing, predicting and prognosticating the outcome of the infection to patients and parents. We report a case of a ten-year-old girl who presented with pyrexia associated with headache, photophobia and abdominal pain. The family had recently acquired two pet rats six weeks ago. She appeared flushed with peri-oral pallor, coated the strawberry tongue, inflamed tonsils and bilateral cervical lymphadenopathy. Her liver and splenic edges were palpable. Investigations showed that she was thrombocytopenic with deranged renal and liver functions. An ultrasound abdomen demonstrated a mildly enlarged spleen, peripancreatic lymph node and an acalculous cholecystitis. In view of her clinical presentation, a diagnosis of leptospirosis was considered and she was commenced on intravenous benzylpenicillin. The following day she became oliguric, developed significant proteinuria and her renal function deteriorated. Following conservative management, her urine output gradually improved along with her renal function, proteinuria and thrombocytopaenia. Serology for leptospirosis and various other viruses were negative. Following discussion with the Rare and Imported Pathogens Laboratory at Porton hanta virus serology was requested and found to be strongly positive for Seoul hanta virus. Following discharge she developed palpitations, fatigue, severe headache and cognitive difficulties including memory loss and difficulties in spelling, reading and mathematics. Extensive investigations including ECG, MRI brain and CSF studies were performed and revealed no significant abnormalities. Since 2012, there have been six cases of acute kidney injury due to Hantavirus infection in the UK. Two cases were from the Humber region and were exposure to wild rats and the other four were exposed to specially bred pet fancy rats. Hanta virus infections can cause mild flu like symptoms but two clinical syndromes are associated with severe disease including haemorrhagic fever with renal syndrome, which may be associated with thrombocytopenia and Hantavirus cardiopulmonary syndrome. Neuropsychological impairments reported following hantavirus pulmonary syndrome and following Puumala virus infection have been reported. Minor white matter lesions were found in about half of the patients investigated with MRI brain. Seoul virus has a global distribution owing to the dispersal of its carrier host rats, through global trade. Several ports in the region could explain the possible establishment of Seoul virus in local populations of rats in the Yorkshire and Humber region. The risk of infection for occupationally exposed groups is 1-3% compared to 32.9% for specialist pet rat owners. The report highlight’s the importance of routinely asking about pets in the family. We hope to raise awareness of the emergence of hantavirus infection in the UK, particularly in the Yorkshire and Humber region. Clinicians should consider hantavirus infection as a potential cause of febrile illness causing renal impairment in children. Awareness of the possible neuro-cognitive sequele would help the clinicians offer appropriate information and support to children and their families. Contacting Rare and Imported Pathogens Laboratory at Porton is a useful resource for clinicians in UK when they consider unusual infections.

Keywords: Seoul hantavirus in child Porton, UK Acute kidney injury

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Authors: Pagadaplly Girish, P. V. Manohar

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Introduction: Management of distal femur fractures is challenging. Recently, treatment has evolved towards indirect reduction and minimally invasive techniques. Objectives: To assess the fracture union and functional outcome following open reduction and internal fixation of distal femur fractures with locking compression plate and to achieve restoration of the anatomical alignment of fracture fragments and stable internal fixation. Methodology: Patients with distal femur fracture treated by locking compression during Oct 2011 to April 2013 were assessed prospectively. Patients below 18 years and those with neuro-vascular deficits were excluded. Age, sex of the patient, type of fracture, mechanism of injury, type of implant used, operative time and postoperative complications were analysed. The Neer’s scale was used to assess the outcome of the patients. Results: The total number of patients was 30; 28 males and 2 females; mean age was 41.53 years. Road traffic accidents were the major causes of injury followed by falls. The average duration of hospital stay was 21.3 days. The overall complication rate note was 23.33%. The mean range of movement around the knee joint after 6 months of follow-up was 114.330. The average time for the radiological union was 14 weeks. Excellent to good results were noted in 26 patients (86.6%) and average to poor results were observed in 4 (13.33%) patients. Conclusions: The locking compression plate gives a rigid fixation for the fracture. It also provides a good purchase in osteoporotic bones. LCP is simple and a reliable implant appropriate for fixation of femoral fractures with promising results.

Keywords: distal femur fractures, locking compression plate, Neer’s criteria, neuro-vascular deficits

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Authors: Okechukwu B. C. Nwankwo

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The surge of social protests sweeping through the globe is a contemporary phenomenon. Yet the phenomenon in itself is not new. Thus, various scholars have over the years developed conceptual frameworks for evaluating it. Adopting and adapting some of these frameworks this paper begins from a purely theoretical perspective exploring the concept and content of social protest within the specific context of Nigeria. It proceeds to build a typology of the phenomenon in terms of form, actors, origin, character, organisation, goal, dynamics, outcome and a whole lot of other variables that are context relevant for evaluating it in an operationally useful manner. The centrality of the context in which protest evolves is demonstrated. Adopting Easton’s systems theory, the paper builds on the assumption that protests emerge whenever and wherever political institutions and structures prove unable or unwilling to transform inputs in form of basic demands into outputs in form of responsive policies. It argues that protests in Nigeria are simply the crystallisation of opposition in the streets. Protests are thus extra-institutional politics. This is usually the case, as elsewhere, where there is no functional institutionalised opposition. Noting that protest, disruptive or otherwise, is an influence strategy, it argues that every single protest is a new opportunity for reform, for reorganisation of state capacities, for modifying rights and obligation of citizens and government to each other. Each reform outcome is, however, only a temporal antecedent. Its extensity gives signal for the next similar protest event. Through providing evidence on how protests in Nigeria create opportunity for reform, for more accountable, more effective governance, the paper shows the positive impact of protests and its importance even in the consolidation effort for the nation’s nascent democracy. Data on protest events will be based on media reports, especially print media.

Keywords: democracy, dialectics, social protest, reform

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Authors: Syed Tahir Shah, Fazal Muhammad, Syed Kashif Shah, Maleeha Gul

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In recent days, natural gas has become a relatively clean and quality source of energy, which is recovered from deep wells by expensive drilling activities. The recovered substance is purified by processing in multiple stages to remove the unwanted/containments like dust, dirt, crude oil and other particles. Mostly, gas utilities are concerned with essential objectives of quantity/quality of natural gas delivery, financial outcome and safe natural gas volumetric inventory in the transmission gas pipeline. Gas quantity and quality are primarily related to standards / advanced metering procedures in processing units/transmission systems, and the financial outcome is defined by purchasing and selling gas also the operational cost of the transmission pipeline. SNGPL (Sui Northern Gas Pipelines Limited) Pakistan has a wide range of diameters of natural gas transmission pipelines network of over 9125 km. This research results in answer a few of the issues in accuracy/metering procedures via multiple advanced gadgets for gas flow attributes after being utilized in the transmission system and research. The effects of good pressure management in transmission gas pipeline network in contemplation to boost the gas volume deposited in the existing network and finally curbing gas losses UFG (Unaccounted for gas) for financial benefits. Furthermore, depending on the results and their observation, it is directed to enhance the maximum allowable working/operating pressure (MAOP) of the system to 1235 PSIG from the current round about 900 PSIG, such that the capacity of the network could be entirely utilized. In gross, the results depict that the current model is very efficient and provides excellent results in the minimum possible time.

Keywords: natural gas, pipeline network, UFG, transmission pack, AGA

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Authors: Shadia Al-Bahlani, Ruqaya Al-Rashdi, Shadia Al-Sinawi, Maya Al-Bahri

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Background: Breast cancer is the most common cancer in women worldwide. Triple-negative breast cancer (TNBC) is an aggressive type of breast cancer, which is defined by the absence of Estrogen (ER), Progesterone (PR) and Human epidermal growth factor (Her-2) receptors. The calpain system plays an important role in many cellular processes including apoptosis, necrosis, cell signaling and proliferation. The role of clapins in pathogenesis and tumor progression has been studied in certain cancer types; however, its definite role is not yet established in breast cancer especially in the TNBC subtype. Objectives: This study aims to measure calpain-1 expression and correlate this measurement with the proliferating/apoptotic index as well with the prognostic factors in TNBC patients’ tissue. Materials and Methods: Thirty nine paraffin blocks from patients diagnosed with TNBC were used to measure the expression of calpain-1 and Ki-67 (proliferating marker) proteins using immunohistochemistry. Apoptosis was assessed morphological and biochemically using conventional Haematoxylin and Eosin (H&E) staining method and terminal deoxynucleotidyl transferase-mediate dUTP nick and labeling (TUNEL) assay respectively. Data was statistically analyzed using Pearson X2 test of association. Results: Calpain-1 content was visualized in the nucleus of the TNBC cells and its expression varied from low to high among the patients tissue. Calpain expression showed no significant correlation with the proliferating/apoptotic index as well with the clinicopathological variables. Apoptotic counts quantified by H&E staining showed significant association with the apoptotic TUNEL assay, validating both approaches. Conclusion: Although calpain-1 expression showed no significant association with the clinical outcome, its variable level of expression might indicate a hidden role in breast cancer tissue. Larger number of samples and different mode of assessments are needed to fully investigate such role. Exploring the involvement of calpain-1 in cancer progression might help in considering it as a biomarker of breast cancer.

Keywords: breast cancer, calpain, apoptosis, prognosis

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Authors: Bui Phuong Linh, Yuki Sakakibara, Ryuto Tanaka, Elizabeth H. Pigney, Taishi Hashiguchi

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Non-alcoholic steatohepatitis (NASH) is a chronic liver disease, often associated with type II diabetes, which sometimes progresses to more serious conditions such as liver fibrosis and hepatocellular carcinoma (HCC). NASH has become an important health problem worldwide, buttherapeutic agents for NASH have not yet been approved, and animal models with high clinical correlation are required. TheSTAM™ mouse shows the same pathological progression as human NASH patients and has been widely used for both drug efficacy and basic research, such as lipid profiling and gut microbiota research. In this study, we analyzed the RNA-seq data of STAM™mice at each pathological stage (steatosis, steatohepatitis, liver fibrosis, and HCC) and examined the clinical correlation at the genetic level. NASH was induced in male mice by a single subcutaneous injection of 200 µg streptozotocin solution 2 days after birth and feeding with high fat dietafter 4 weeks of age. The mice were sacrificed and livers collected at 6, 8, 10, 12, 16, and 20 weeks of age. For liver samples, the left lateral lobe was snap frozen in liquid nitrogen and stored at -80˚C for RNA-seq analysis. Total RNA of the cells was isolated using RNeasy mini kit. The gene expression of the canonical pathways in NASH progression from steatosis to hepatocellular carcinoma were analyzed, such as immune system process, oxidation-reduction process, lipid metabolic process. Moreover, since it has been reported that genetic traits are involved in the development of NASH-HCC, we next analyzed the genetic mutations in the STAM™mice. The number of individuals showing mutations in Mtorinvolved in Insulin signaling increases as the disease progresses, especially in the liver cancer phase. These results indicated a clinical correlation of gene profiles in the STAM™mouse.

Keywords: steatosis, non-alcoholic steatohepatitis, fibrosis, hepatocellular carcinoma, RNA-seq

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Authors: Shazia Anwer Bukhari, Madiha Javeed Ghani, Muhammad Ibrahim Rajoka

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Objective: Biochemical, environmental, physical and genetic factors have a strong effect on the development of coronary disease (CAD). Plasma homocysteine (Hcy) level and DNA damage play a pivotal role in its development and progression. The aim of this study was to investigate the predictive strength of an oxidative stress, clinical biomarkers and total antioxidant status (TAS) in CAD patients to find the correlation of homocysteine, TOS and oxidative DNA damage with other clinical parameters. Methods: Sixty confirmed patients with CAD and 60 healthy individuals as control were included in this study. Different clinical and laboratory parameters were studied in blood samples obtained from patients and control subjects using commercially available biochemical kits and statistical software Results: As compared to healthy individuals, CAD patients had significantly higher concentrations of indices of oxidative stress: homocysteine (P=0.0001), total oxidative stress (TOS) (P=0.0001), serum cholesterol (P=0.04), low density lipoprotein cholesterol (LDL) (P=0.01), high density lipoprotein-cholesterol (HDL) (P=0.0001), and malondialdehyde (MDA) (P=0.001) than those of healthy individuals. Plasma homocysteine level and oxidative DNA damage were positively correlated with cholesterol, triglycerides, systolic blood pressure, urea, total protein and albumin (P values= 0.05). Both Hcy and oxidative DNA damage were negatively correlated with TAS and proteins. Conclusion: Coronary artery disease patients had a significant increase in homocysteine level and DNA damage due to increased oxidative stress. In conclusion, our study shows a significantly increase in lipid peroxidation, TOS, homocysteine and DNA damage in the erythrocytes of patients with CAD. A significant decrease level of HDL-C and TAS was observed only in CAD patients. Therefore these biomarkers may be useful diagnosis of patients with CAD and play an important role in the pathogenesis of CAD.

Keywords: antioxidants, coronary artery disease, DNA damage, homocysteine, oxidative stress, malondialdehyde, 8-Hydroxy-2’deoxyguanosine

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Authors: Alison Ryan, Himani Chhabra, Mohammed Dungarwalla, Judith Jones

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Background: Impacted and ectopic teeth present in 1-2% of orthodontic patients and often require joint surgical and orthodontic management. The authors present two patients undergoing orthodontic treatment, where the impacted teeth, in a hopeless position, spontaneously erupted during the period of cessation of general anaesthetic lists during the COVID-19 pandemic. Patient information: A healthy 11-year-old boy was referred to the Department of Oral and Maxillofacial Surgery for the management of a mesioangular impacted LR7. The patient was seen by the joint oral surgery/orthodontic team, who planned for the removal of the LR7 under general anaesthetic. A healthy 13-year-old boy was referred to the same Department and team for surgical extraction of unerupted and buccally impacted UL3 and UR3 under general anaesthetic. Management and outcome: The majority of elective dental-alveolar work ceased as a result of the global pandemic. On resumption of activity, the first patient was reviewed in July 2021. The LR7 had spontaneously erupted in a favourable position, and following MDT review, a decision was made to forgo any further surgical intervention. The second patient was reviewed in July 2021. The UL3 had clinically erupted, and there was radiographic evidence of favourable movement of UR3. Due to the nature of the patient’s malocclusion, the decision was made to proceed with the extractions as previously planned. Key Learning Points: Severely impacted teeth do have a prospect of spontaneous eruption or alignment without clinical intervention, and current literature states the initial location, axial inclination, degree of root formation, and relation of the impacted tooth to adjacent teeth roots may influence spontaneous eruption. There is potential to introduce a period of observation to account for this possibility in the developing dentition, with the aim of reducing the unnecessary need for surgical intervention. This could help prevent episodes of general anaesthetic and allocate theatre space more appropriately.

Keywords: spontaneous eruption, impaction, observation, hopeless position, surgical, orthodontic, change in treatment plan

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Authors: Vanessa Roulet, Marc Turini, Juliane Hey, Stéphanie Bord-Romeu, Emilie Bonzom, Mahmoud Badawi, Mohammed-Amine Chakir, Valérie Simon, Vanessa Viotti, Jérémie Gautier, Françoise Le Boulaire, Catherine Coignard, Claire Vincent, Sandrine Greaume, Isabelle Voisin

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Background: Beckman Coulter, Inc. has recently developed fully automated assays for the detection of HBsAg on a new immunoassay platform. The objective of this European multicenter study was to evaluate the performance of the ACCESS HBsAg and ACCESS HBsAg Confirmatory assays† on the recently CE-marked DxI 9000 ACCESS Immunoassay Analyzer. Methods: The clinical specificity of the ACCESS HBsAg and HBsAg Confirmatory assays was determined using HBsAg-negative samples from blood donors and hospitalized patients. The clinical sensitivity was determined using presumed HBsAg-positive samples. Sample HBsAg status was determined using a CE-marked HBsAg assay (Abbott ARCHITECT HBsAg Qualitative II, Roche Elecsys HBsAg II, or Abbott PRISM HBsAg assay) and a CE-marked HBsAg confirmatory assay (Abbott ARCHITECT HBsAg Qualitative II Confirmatory or Abbott PRISM HBsAg Confirmatory assay) according to manufacturer package inserts and pre-determined testing algorithms. False initial reactive rate was determined on fresh hospitalized patient samples. The sensitivity for the early detection of HBV infection was assessed internally on thirty (30) seroconversion panels. Results: Clinical specificity was 99.95% (95% CI, 99.86 – 99.99%) on 6047 blood donors and 99.71% (95%CI, 99.15 – 99.94%) on 1023 hospitalized patient samples. A total of six (6) samples were found false positive with the ACCESS HBsAg assay. None were confirmed for the presence of HBsAg with the ACCESS HBsAg Confirmatory assay. Clinical sensitivity on 455 HBsAg-positive samples was 100.00% (95% CI, 99.19 – 100.00%) for the ACCESS HBsAg assay alone and for the ACCESS HBsAg Confirmatory assay. The false initial reactive rate on 821 fresh hospitalized patient samples was 0.24% (95% CI, 0.03 – 0.87%). Results obtained on 30 seroconversion panels demonstrated that the ACCESS HBsAg assay had equivalent sensitivity performances compared to the Abbott ARCHITECT HBsAg Qualitative II assay with an average bleed difference since first reactive bleed of 0.13. All bleeds found reactive in ACCESS HBsAg assay were confirmed in ACCESS HBsAg Confirmatory assay. Conclusion: The newly developed ACCESS HBsAg and ACCESS HBsAg Confirmatory assays from Beckman Coulter have demonstrated high clinical sensitivity and specificity, equivalent to currently marketed HBsAg assays, as well as a low false initial reactive rate. †Pending achievement of CE compliance; not yet available for in vitro diagnostic use. 2023-11317 Beckman Coulter and the Beckman Coulter product and service marks mentioned herein are trademarks or registered trademarks of Beckman Coulter, Inc. in the United States and other countries. All other trademarks are the property of their respective owners.

Keywords: dxi 9000 access immunoassay analyzer, hbsag, hbv, hepatitis b surface antigen, hepatitis b virus, immunoassay

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Authors: Rakan Alajmi, Rahaf Alnazzawi, Yara Aljefri, Abdullah Alafif, Ali Alraddadi, Awadh Alamri

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Background: The distribution of physicians in different specialties across Saudi Arabia is determined by the career choices of medical students. Dermatology residency program is one of the highly competitive programs here in Saudi Arabia. Assessing and understanding the factors perceived to be attractive in choosing dermatology will aid the directors of the specialty programs to plan for a more balanced workforce distribution to better suit the needs of the specialties. Aim: The aim of our study is to determine and assess the factors perceived to be significantly attractive when choosing dermatology as a future specialty. Methods: The study is a cross-sectional study conducted in King Saud bin Abdulaziz University for Health Sciences, Jeddah, Saudi Arabia. A validated questionnaire was sent electronically to clinical year medical students. In addition to the questionnaire, gender, grade point average, preferred specialty, and other socio-demographic data were assessed. Results: A total of 121 clinical years medical students completed the questionnaire, 8 (6.6%) preferred dermatology as a specialty. 76 (62.8%) of the participants score a grade point average of more than 4.5 and 83 students (68.6%) chose their specialty during clinical years. The appeal of being a dermatologist (P= 0.047), the portrayal of different specialities in the media (P= 0.005), and the likelihood that dermatologists can influence patients’ lives (P=0.010) were shown to be significantly attractive factors. Conclusion: There are many factors that are affecting students’ choices when choosing a medical specialty. The appeal of being a dermatologist, the portrayal of different specialities in the media, and the likelihood that dermatologists can influence patients’ lives were shown to be significantly attractive factors when choosing dermatology as a future specialty. Recognizing medical students’ specialty perception will lead them to a proper specialty tailored to their needs.

Keywords: dermatology, career choice, medical specialties, student's perception

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Authors: Meenakshi Barsaul Chauhan, Aastha Chauhan, Shilpa Hurmade, Rajeev Sen, Jyotsna Sen, Monika Dalal

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Introduction: Ovarian masses are common forms of neoplasm in women and represent 2/3rd of gynaecological malignancies. A pre-operative suggestion of malignancy can guide the gynecologist to refer women with suspected pelvic mass to a gynecological oncologist for appropriate therapy and optimized treatment, which can improve survival. In the younger age group preoperative differentiation into benign or malignant pathology can decide for conservative or radical surgery. Imaging modalities have a definite role in establishing the diagnosis. By using International Ovarian Tumor Analysis (IOTA) classification with sonography, costly radiological methods like Magnetic Resonance Imaging (MRI) / computed tomography (CT) scan can be reduced, especially in developing countries like India. Thus, this study is being undertaken to evaluate the role of clinical methods and sonography for diagnosis of the nature of the ovarian tumor. Material And Methods: This prospective observational study was conducted on 40 patients presenting with ovarian masses, in the Department of Obstetrics and Gynaecology, at a tertiary care center in northern India. Functional cysts were excluded. Ultrasonography and color Doppler were performed on all the cases.IOTA rules were applied, which take into account locularity, size, presence of solid components, acoustic shadow, dopper flow etc . Magnetic Resonance Imaging (MRI) / computed tomography (CT) scans abdomen and pelvis were done in cases where sonography was inconclusive. In inoperable cases, Fine needle aspiration cytology (FNAC) was done. The histopathology report after surgery and cytology report after FNAC was correlated statistically with the pre-operative diagnosis made clinically and sonographically using IOTA rules. Statistical Analysis: Descriptive measures were analyzed by using mean and standard deviation and the Student t-test was applied and the proportion was analyzed by applying the chi-square test. Inferential measures were analyzed by sensitivity, specificity, negative predictive value, and positive predictive value. Results: Provisional diagnosis of the benign tumor was made in 16(42.5%) and of the malignant tumor was made in 24(57.5%) patients on the basis of clinical findings. With IOTA simple rules on sonography, 15(37.5%) were found to be benign, while 23 (57.5%) were found to be malignant and findings were inconclusive in 2 patients (5%). FNAC/Histopathology reported that benign ovarian tumors were 14 (35%) and 26(65%) were malignant, which was taken as the gold standard. The clinical finding alone was found to have a sensitivity of 66.6% and a specificity of 90.9%. USG alone had a sensitivity of 86% and a specificity of 80%. When clinical findings and IOTA simple rules of sonography were combined (excluding inconclusive masses), the sensitivity and specificity were 83.3% and 92.3%, respectively. While including inconclusive masses, sensitivity came out to be 91.6% and specificity was 89.2. Conclusion: IOTA's simple sonography rules are highly sensitive and specific in the prediction of ovarian malignancy and also easy to use and easily reproducible. Thus, combining clinical examination with USG will help in the better management of patients in terms of time, cost and better prognosis. This will also avoid the need for costlier modalities like CT, and MRI.

Keywords: benign, international ovarian tumor analysis classification, malignant, ovarian tumours, sonography

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Authors: Angela T. H. Kwan, Wenjun Liang, Jack Wellington, Mohammad Mofatteh, Thanh N. Nguyen, Pingzhong Fu, Juanmei Chen, Zile Yan, Weijuan Wu, Yongting Zhou, Shuiquan Yang, Sijie Zhou, Yimin Chen

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Background: Endovascular Therapy (EVT)—in the form of mechanical thrombectomy—following intravenous thrombolysis is the standard gold treatment for patients with acute ischemic stroke (AIS) due to large vessel occlusion (LVO). It is well established that an ASPECTS ≥ 7 is associated with an increased likelihood of positive post-EVT outcomes, as compared to an ASPECTS < 7. There is also prognostic utility in coupling posterior circulation ASPECTS (pc-ASPECTS) with magnetic resonance imaging for evaluating the post-EVT functional outcome. However, the value of pc-ASPECTS applied to CT must be explored further to determine its usefulness in predicting functional outcomes following EVT. Objective: In this study, we aimed to determine whether pc-ASPECTS on CT can predict post-EVT functional outcomes among patients with AIS due to LVO. Methods: A total of 247 consecutive patients aged 18 and over receiving EVT for LVO-related AIS were recruited into a prospective database. The data were retrospectively analyzed between March 2019 to February 2022 from two comprehensive tertiary care stroke centers: Foshan Sanshui District People’s Hospital and First People's Hospital of Foshan in China. Patient parameters included EVT within 24hrs of symptom onset, premorbid modified Rankin Scale (mRS) ≤ 2, presence of distal and terminal cerebral blood vessel occlusion, and subsequent 24–72-hour post-stroke onset CT scan. Univariate comparisons were performed using the Fisher exact test or χ2 test for categorical variables and the Mann–Whitney U test for continuous variables. A p-value of ≤ 0.05 was statistically significant. Results: A total of 247 patients met the inclusion criteria; however, 3 were excluded due to the absence of post-CTs and 8 for pre-EVT ASPECTS < 7. Overall, 236 individuals were examined: 196 anterior circulation ischemic strokes and 40 posterior strokes of basilar artery occlusion. We found that both baseline post- and pc-ASPECTS ≥ 7 serve as strong positive markers of favorable outcomes at 90 days post-EVT. Moreover, lower rates of inpatient mortality/hospice discharge, 90-day mortality, and 90-day poor outcome were observed. Moreover, patients in the post-ASPECTS ≥ 7 anterior circulation group had shorter door-to-recanalization time (DRT), puncture-to-recanalization time (PRT), and last known normal-to-puncture-time (LKNPT). Conclusion: Patients of anterior and posterior circulation ischemic strokes with baseline post- and pc-ASPECTS ≥ 7 may benefit from EVT.

Keywords: endovascular therapy, thrombectomy, large vessel occlusion, cerebral ischemic stroke, ASPECTS

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Authors: Evangelia Kotrotsiou, Mairy Gouva, Theodosios Paralikas, Maria Fiaka, Styliani Kotrotsiou, Maria Malliarou

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The purpose of this research is to investigate the way nurses perceive the care provided in comparison to the way patients perceive it, taking into account existing literature. As far as the sample of research is concerned, it has come from the population of nurses working in the General Hospital of Thessaloniki, St. Paul and the patients of its surgical clinic. In the present study, the sample consists of 100 nurses and 88 patients. The questionnaire used was the Caring Nurse-Patient Interactions Scale: 23-Item Version, created by Cossette et al. (2006). In the case of both patients and nurses, a high score was observed in relational care in the case of the frequency of nursing care in daily practice, as well as the satisfaction of providing nursing care. Overall, patients rated higher clinical care in the case of the frequency of nursing care in daily practice, as well as the satisfaction of the clinical care they were given. On the other hand, nurses rated higher comfort care in the case of the frequency of nursing care in everyday practice, as well as relational care in the area of the importance of nursing care in everyday practice.

Keywords: nursing care, patient needs, patient satisfaction, care giving

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Authors: Priscilla Akua Agyapong

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Background: In a country of nearly 34 million people, Ghana suffers from rapidly growing pediatric CHD cases and not enough pediatric specialists to attend to the burgeoning needs of these children. Most of the cases are either missed or diagnosed late, resulting in increased mortality. According to the National Cardiothoracic Centre, 1 in every 100,000 births in Ghana has CHD; however, there is limited data on the clinical presentation and its management, one of the many reasons I decided to do this case study coupled with the loss my 2 month old niece to multiple Ventricular Septal Defect 3 years ago due late diagnoses. Method: A retrospective cohort study was performed at the child health clinic of one of Ghana’s public tertiary Institutions using data from their electronic health record (EHR) from February 2021 to April 2022. All suspected or provisionally diagnosed cases were included in the analysis. Results: Records of over 3000 children were reviewed with an approximate male to female ratio of 1:1.53 cases diagnosed during the period of study, most of whom were less than 5 years of age. 25 cases had complete clinical records, with acyanotic septal defects being the most diagnosed. 62.5% of the cases were ventricular septal defects, followed by Patent Ductus Arteriosus (23%) and Atrial Septal Defects (4.5%). Tetralogy of Fallot was the most predominant and complex cyanotic CHD with 10%. Conclusion: The indeterminate coronary anatomy of infants makes it difficult to use only echocardiography and other conventional clinical methods in screening for CHDs. There are rising modernizations and new innovative ways that can be employed in Ghana for early detection, hence preventing the delay of a potential surgical repair. It is, therefore, imperative to create the needed awareness about these “SILENT CRISES” and help save the Ghanaian child’s life.

Keywords: congenital heart defect(CHD), ventricular septal defect(VSD), atrial septal defect(ASD), patent ductus arteriosus(PDA)

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Authors: Mihail Nagea, Olivera Lupescu, Nicolae Ciurea, Alexandru Dimitriu, Alina Grosu

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Introduction: As severe open injuries are more and more frequent in modern traumatology, threatening not only the integrity of the affected limb but even the life of the patients, new methods desired to cope with the consequences of these traumas were described. Vacuum therapy is one such method which has been described as enhancing healing in trauma with extensive soft-tissue injuries, included those with septic complications. Material and methods: Authors prospectively analyze 15 patients with severe lower limb trauma with MESS less than 6, with considerable soft tissue loss following initial debridement and fracture fixation. The patients needed serial debridements and vacuum therapy was applied after delayed healing due to initial severity of the trauma, for an average period of 12 days (7 - 23 days).In 7 cases vacuum therapy was applied for septic complications. Results: Within the study group, there were no local complications; secondary debridements were performed for all the patients and vacuum system was re-installed after these debridements. No amputations were needed. Medical records were reviewed in order to compare the outcome of the patients: the hospital stay, anti-microbial therapy, time to healing of the bone and soft tissues (there is no standard group to be compared with) and the result showed considerable improvements in the outcome of the patients. Conclusion: Vacuum therapy improves healing of the soft tissues, including those infected; hospital stay and the number of secondary necessary procedures are reduced. Therefore it is considered a valuable support in treating trauma of the limbs with severe soft tissue injuries.

Keywords: complex injuries, negative pressure, open fractures, wound therapy

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Authors: James Boag

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The needs of people with a diagnosis of dementia and their carers and families are physical, psychosocial, and psychological and begin at the time of diagnosis. There is frequently a lack of emotional support and counselling. Care- giving support is required from the presentation of the first symptoms of dementia until death. Alzheimer's disease begins decades before the clinical symptoms begin to appear, and in many cases, it remains undiagnosed, or diagnosed too late for any possible interventions to have any effect. However, if an incorrect diagnosis is given, it may result in a person being treated, without effect, for a type of dementia they do not have and delaying the interventions they should have received. Being diagnosed with dementia can cause emotional distress to the person, and physical and emotional support is needed, which will become more important as the disease progresses. The severity of the patient's dementia and their symptoms has a bearing of the impact on the carer and the support needed. A lack of insight and /or a denial of the diagnosis, grief, reacting to anticipated future losses, and coping methods to maximise the disease outcome, are things that should be addressed. Because of the stigma, it is important for carers not to lose contact with family and others because social isolation leads to depression and burnout. The impact on a carer's well- being and quality of life can be influenced by the severity of the illness, its type of dementia, its symptoms, healthcare support, financial and social status, career, age, health, residential setting, and relationship to the patient. Carer burnout due to lack of support leads to people diagnosed with dementia being put into residential care prematurely. Often dementia is not recognised as a terminal illness, limiting the ability of the person diagnosed with dementia and their carers to work on advance care planning and getting access to palliative and other support. Many carers have been satisfied with the physical support they were given in their everyday life, however, it was agreed that there was an immense unmet need for psychosocial support, especially after diagnosis and approaching end of life. Providing continuity and coordination of care is important. Training is necessary for providers to understand that every case is different, and they should understand the complexities. Grief, the emotional response to loss, is suffered during the progression of the disease and long afterwards, and carers should continue to be supported after the death of the person they were caring for.

Keywords: dementia, caring, challenges, needs

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Authors: Chan Eang Teng, Tang Mui Joo

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With the viral factor on social media, the sense of persuasion is generated by repetition and popularity. When users’ interest is captured, political awareness increases to spark political enthusiasm, but, the level of user’s political participation and political attitude of those active users is still questionable. An online survey on 250 youth and in-depth interview on two politicians are conducted to answer the main question in this paper. The result shows that Facebook significantly increases political awareness among youths. Social media may not be the major trigger to political activism among youths as most respondents opined that they would still vote without Facebook. Other factors could be political campaigning, political climate, age, peer pressure or others. Finding also shows that majority of respondents did not participate in online political debates or political groups. Many also wondered if the social media was the main power switch that triggers the political influx among young voters. The research finding is significant to understand how the new media, Facebook, has reshaped the political landscape in Malaysia, creating the Social Media Election that changed the rules of the political game. However, research finding does not support the ideal notion that the social media is the major trigger to youth’s political activism. This research outcome has exposed the flaws of the Social Media Election. It has revealed the less optimistic side of youth political activism. Unfortunately, results fall short of the idealistic belief that the social media have given rise to political activism among youths in the 13^th General Election in Malaysia. The research outcome also highlights an important lesson for the democratic discourse of Malaysia which is making informed and educated decisions takes more commitment, proactive and objective attitude.

Keywords: social media, political participation, political activism, democracy, political communication

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Authors: Ghadeer Mohammad Said El-Sheikh, Samer Mohamad Shalhoob

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Medical equipment operation state is a valid reflection of health care organizations' performance, where such equipment highly contributes to the quality of healthcare services on several levels in which quality improvement has become an intrinsic part of the discourse and activities of health care services. In healthcare organizations, clinical and biomedical engineering departments play an essential role in maintaining the safety and efficiency of such equipment. One of the most challenging topics when it comes to such sophisticated equipment is the lifespan of medical equipment, where many factors will impact such characteristics of medical equipment through its life cycle. So far, many attempts have been made in order to address this issue where most of the approaches are kind of arbitrary approaches and one of the criticisms of existing approaches trying to estimate and understand the lifetime of a medical equipment lies under the inquiry of what are the environmental factors that can play into such a critical characteristic of a medical equipment. In an attempt to address this shortcoming, the purpose of our study rises where in addition to the standard technical factors taken into consideration through the decision-making process by a clinical engineer in case of medical equipment failure, the dimension of environmental factors shall be added. The investigations, researches and studies applied for the purpose of supporting the decision making process by a clinical engineers and assessing the lifespan of healthcare equipment’s in the Lebanese society was highly dependent on the identification of technical criteria’s that impacts the lifespan of a medical equipment where the affecting environmental factors didn’t receive the proper attention. The objective of our study is based on the need for introducing a new well-designed plan for evaluating medical equipment depending on two dimensions. According to this approach, the equipment that should be replaced or repaired will be classified based on a systematic method taking into account two essential criteria; the standard identified technical criteria and the added environmental criteria.

Keywords: technical, environmental, healthcare, characteristic of medical equipment

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Authors: Mari A. Virtanen, Elina Haavisto, Eeva Liikanen, Maria Kääriäinen

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Rapid technological development and digitalization has affected also on higher education. During last twenty years multiple of electronic and mobile learning (e-learning, m-learning) platforms have been developed and have become prevalent in many universities and in the all fields of education. Ubiquitous learning (u-learning) is not that widely known or used. Ubiquitous learning environments (ULE) are the new era of computer-assisted learning. They are based on ubiquitous technology and computing that fuses the learner seamlessly into learning process by using sensing technology as tags, badges or barcodes and smart devices like smartphones and tablets. ULE combines real-life learning situations into virtual aspects and can be flexible used in anytime and anyplace. The aim of this study was to assess the effects of ubiquitous 360 o learning environment on higher education students’ clinical histotechnology competence. A quasi-experimental study design was used. 57 students in biomedical laboratory science degree program was assigned voluntarily to experiment (n=29) and to control group (n=28). Experimental group studied via ubiquitous 360o learning environment and control group via traditional web-based learning environment (WLE) in a 8-week educational intervention. Ubiquitous 360o learning environment (ULE) combined authentic learning environment (histotechnology laboratory), digital environment (virtual laboratory), virtual microscope, multimedia learning content, interactive communication tools, electronic library and quick response barcodes placed into authentic laboratory. Web-based learning environment contained equal content and components with the exception of the use of mobile device, interactive communication tools and quick response barcodes. Competence of clinical histotechnology was assessed by using knowledge test and self-report developed for this study. Data was collected electronically before and after clinical histotechnology course and analysed by using descriptive statistics. Differences among groups were identified by using Wilcoxon test and differences between groups by using Mann-Whitney U-test. Statistically significant differences among groups were identified in both groups (p<0.001). Competence scores in post-test were higher in both groups, than in pre-test. Differences between groups were very small and not statistically significant. In this study the learning environment have developed based on 360o technology and successfully implemented into higher education context. And students’ competence increases when ubiquitous learning environment were used. In the future, ULE can be used as a learning management system for any learning situation in health sciences. More studies are needed to show differences between ULE and WLE.

Keywords: competence, higher education, histotechnology, ubiquitous learning, u-learning, 360o

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Authors: Mehrnaz Mostafavi, Mahtab Shabani, Alireza Azani, Fatemeh Ghafari

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Artificial intelligence (AI) can transform breast cancer diagnosis and therapy by providing sophisticated solutions for screening, imaging interpretation, histopathological analysis, and treatment planning. This literature review digs into the many uses of AI in breast cancer treatment, highlighting the need for collaboration between AI scientists and healthcare practitioners. It emphasizes advances in AI-driven breast imaging interpretation, such as computer-aided detection and diagnosis (CADe/CADx) systems and deep learning algorithms. These have shown significant potential for improving diagnostic accuracy and lowering radiologists' workloads. Furthermore, AI approaches such as deep learning have been used in histopathological research to accurately predict hormone receptor status and categorize tumor-associated stroma from regular H&E stains. These AI-powered approaches simplify diagnostic procedures while providing insights into tumor biology and prognosis. As AI becomes more embedded in breast cancer care, it is crucial to ensure its ethical, efficient, and patient-focused implementation to improve outcomes for breast cancer patients ultimately.

Keywords: breast cancer, artificial intelligence, cancer diagnosis, clinical practice

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Authors: Claire Williams

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

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

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Authors: Mukesh Ravi Raushan

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Despite consideration of obesity as a deadly public health issue contributing 2.6 million deaths worldwide every year developing country like India is facing malnutrition and it is more common than in Sub-Saharan Africa. About one in every three malnourished children in the world lives in India. The paper assess the nutritional health among children using data from total number of 43737 infant and young children aged 0-59 months (µ = 29.54; SD = 17.21) of the selected households by National Family Health Survey, 2005-06. The wasting was measured by a Z-score of standardized weight-for-height according to the WHO child growth standards. The impact of education with place of residence was found to be significantly associated with the complementary food diversity score (CFDS) in India. The education of mother was positively associated with the CFDS but the degree of performance was lower in rural India than their counterpart from urban. The result of binary logistic regression on wasting with WHO seven types of recommended food for children in India suggest that child who consumed the milk product food (OR: 0.87, p<0.0001) were less likely to be malnourished than their counterparts who did not consume, whereas, in case of other food items as the child who consumed food product of seed (OR: 0.75, p<0.0001) were less likely to be malnourished than those who did not. The nutritional status among children were negatively associated with the protein containing complementary food given the child as those child who received pulse in last 24 hour were less likely to be wasted (OR: 0.87, p<0.00001) as compared to the reference categories. The frequency to feed the indexed child increases by 10 per cent the expected change in child health outcome in terms of wasting decreases by 2 per cent in India when place of residence, education, religion, and birth order were controlled. The index gets improved as the risk for malnutrition among children in India decreases.

Keywords: CFDS, food diversity index, India, logistic regression

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Authors: Ammar Asma, Bouafia Nabiha, Ghammam Rim, Ezzi Olfa, Ben Cheikh Asma, Mahjoub Mohamed, Helali Radhia, Sma Nesrine, Chouchène Imed, Boussarsar Hamadi, Njah Mansour

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Background: Central venous catheter associated infections (CVC-AI) are among the serious hospital-acquired infections. The aims of this study are to determine the incidence of CVC-AI, and their risk factors among patients followed in a Tunisian medical intensive care unit (ICU). Materials / Methods: A prospective cohort study conducted between September 15th, 2015 and November 15th, 2016 in an 8-bed medical ICU including all patients admitted for more than 48h. CVC-AI were defined according to CDC of ATLANTA criteria. The enrollment was based on clinical and laboratory diagnosis of CVC-AI. For all subjects, age, sex, underlying diseases, SAPS II score, ICU length of stay, exposure to CVC (number of CVC placed, site of insertion and duration catheterization) were recorded. Risk factors were analyzed by conditional stepwise logistic regression. The p-value of < 0.05 was considered significant. Results: Among 192 eligible patients, 144 patients (75%) had a central venous catheter. Twenty-eight patients (19.4%) had developed CVC-AI with density rate incidence 20.02/1000 CVC-days. Among these infections, 60.7% (n=17) were systemic CVC-AI (with negative blood culture), and 35.7% (n=10) were bloodstream CVC-AI. The mean SAPS II of patients with CVC-AI was 32.76 14.48; their mean Charlson index was 1.77 1.55, their mean duration of catheterization was 15.46 10.81 days and the mean duration of one central line was 5.8+/-3.72 days. Gram-negative bacteria was determined in 53.5 % of CVC-AI (n= 15) dominated by multi-drug resistant Acinetobacter baumani (n=7). Staphylococci were isolated in 3 CVC-AI. Fourteen (50%) patients with CVC-AI died. Univariate analysis identified men (p=0.034), the referral from another hospital department (p=0.03), tobacco (p=0.006), duration of sedation (p=0.003) and the duration of catheterization (p=0), as possible risk factors of CVC-AI. Multivariate analysis showed that independent factors of CVC-AI were, male sex; OR= 5.73, IC 95% [2; 16.46], p=0.001, Ramsay score; OR= 1.57, IC 95% [1.036; 2.38], p=0.033, and duration of catheterization; OR=1.093, IC 95% [1.035; 1.15], p=0.001. Conclusion: In a monocenter cohort, CVC-AI had a high density and is associated with poor outcome. Identifying the risk factors is necessary to find solutions for this major health problem.

Keywords: central venous catheter associated infection, intensive care unit, prospective cohort studies, risk factors

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