Search results for: clinical research

Authors: Keenoo Bibi Sumera, Alsheikh Mona, Mubarak Jan Beebee Zeba Mahetaab

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Background: Due to the busy schedule of the practicing clinicians at the hospitals, students may not always be attended to, which is to their detriment. The clinicians at the hospitals are also not always acquainted with teaching and/or supervising students on their placements. Additionally, there is a high student-patient ratio. Since they are the prospective clinical doctors under training, they need to reach the competence levels in clinical decision-making skills to be able to serve the healthcare system of the country and to be safe doctors. Aims and Objectives: A reflective portfolio was used to provide a means for students to learn by reflecting on their experiences and obtaining continuous feedback. This practice is an attempt to compensate for the scarcity of lack of resources, that is, clinical placement supervisors and patients. It is also anticipated that it will provide learners with a continuous monitoring and learning gap analysis tool for their clinical skills. Methodology: A hardcopy reflective portfolio was designed and validated. The portfolio incorporated a mini clinical evaluation exercise (mini-CEX), direct observation of procedural skills and reflection sections. Workshops were organized for the stakeholders, that is the management, faculty and students, separately. The rationale of reflection was emphasized. Students were given samples of reflective writing. The portfolio was then implemented amongst the undergraduate medical students of years four, five and six during clinical clerkship. After 16 weeks of implementation of the portfolio, a survey questionnaire was introduced to explore how undergraduate students perceive the educational value of the reflective portfolio and its impact on their deep information processing. Results: The majority of the respondents are in MD Year 5. Out of 52 respondents, 57.7% were doing the internal medicine clinical placement rotation, and 42.3% were in Otorhinolaryngology clinical placement rotation. The respondents believe that the implementation of a reflective portfolio helped them identify their weaknesses, gain professional development in terms of helping them to identify areas where the knowledge is good, increase the learning value if it is used as a formative assessment, try to relate to different courses and in improving their professional skills. However, it is not necessary that the portfolio will improve the self-esteem of respondents or help in developing their critical thinking, The portfolio takes time to complete, and the supervisors are not useful. They had to chase supervisors for feedback. 53.8% of the respondents followed the Gibbs reflective model to write the reflection, whilst the others did not follow any guidelines to write the reflection 48.1% said that the feedback was helpful, 17.3% preferred the use of written feedback, whilst 11.5% preferred oral feedback. Most of them suggested more frequent feedback. 59.6% of respondents found the current portfolio user-friendly, and 28.8% thought it was too bulky. 27.5% have mentioned that for a mobile application. Conclusion: The reflective portfolio, through the reflection of their work and regular feedback from supervisors, has an overall positive impact on the learning process of undergraduate medical students during their clinical clerkship.

Keywords: Portfolio, Reflection, Feedback, Clinical Placement, Undergraduate Medical Education

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Authors: Mecheri Zeid Belmecheri, Maamar Ahfir, Izzet Kale

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Automatic cardiac auscultation is still a subject of research in order to establish an objective diagnosis. Recorded heart sounds as Phonocardiogram signals (PCG) can be used for automatic segmentation into components that have clinical meanings. These are the first sound, S1, the second sound, S2, and the systolic and diastolic components, respectively. In this paper, an automatic method is proposed for the robust segmentation of heart sounds. This method is based on calculating an intermediate sawtooth-shaped signal from the length variation of the recorded Phonocardiogram (PCG) signal in the time domain and, using its positive derivative function that is a binary signal in training a Recurrent Neural Network (RNN). Results obtained in the context of a large database of recorded PCGs with their simultaneously recorded ElectroCardioGrams (ECGs) from different patients in clinical settings, including normal and abnormal subjects, show a segmentation testing performance average of 76 % sensitivity and 94 % specificity.

Keywords: heart sounds, PCG segmentation, event detection, recurrent neural networks, PCG curve length

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Authors: Kevin Yeo, Christine Hall, Babinchak Tim

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BAT® [Botulism Antitoxin Heptavalent (A,B,C,D,E,F,G)-(Equine)] anti-toxin is a mixture of equine immune globulin fragments indicated for the treatment of symptomatic botulism in adult and pediatric patients. The effectiveness of BAT anti-toxin is based on efficacy studies conducted in animal models. A general explanation of the pivotal animal studies, post market surveillance and outcomes of an observational patient registry for patients treated with BAT product distributed in the USA is briefly discussed. Overall it took 20 animal studies for two well-designed and appropriately powered pivotal efficacy studies – one in which the effectiveness of BAT was assessed against all 7 serotypes in the guinea pig, and the other where efficacy is confirmed in the Rhesus macaque using Serotype A. Clinical Experience for BAT to date involves approximately 600 adult and pediatric patients with suspected botulism. In pre-licensure, patient data was recorded under the US CDC expanded access program (259 adult and pediatric patients between 10 days to 88 years of age). In post licensure, greater than 350 patients to date have received BAT and been followed up by enhanced expanded access program. The analysis of the post market surveillance data provided a unique opportunity to demonstrate clinical benefit in the field study required by the animal rule. While the animal rule is applied because human efficacy studies are not ethical or feasible, a post-marketing requirement is to conduct a study to evaluate safety and clinical benefit when circumstances arise and demonstrate the favourable benefit-risk profile that supported licensure.

Keywords: botulism, threat, clinical benefit, observational patient registry

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Authors: Camille Plant, Katherine McGill, Pek Ang

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Oncology patients face a host of unique challenges, which are physical, psychological and philosophical in nature. This preliminary study aimed to explore the psychiatric morbidity of oncology patients in an outpatient setting at a major public hospital in Australia. The study found that 33 patients were referred to a Psychiatrist by a Clinical Psychologist or treating Oncologist. These patients attended an outpatient Psychiatry appointment at the Calvary Mater Hospital, Newcastle, over a 7 month period (June 2017-January 2018). Of these, 45% went on to have a follow-up appointment. The Clinical Global Impressions Scale (CGI) was used to gather symptom severity scores at baseline and at follow-up. The CGI is a clinician determined instrument that provides an assessment of global functioning. It is comprised of two companion one-item measures: the CGI-Severity (CGI-S) rates mental illness severity, and the CGI-Improvement (CGI-I) rates change in condition or improvement from initiation of treatment. Patients referred to a Psychiatrist were observed to be on average in the Markedly ill approaching Severely ill range (CGI-S average of 5.5). However, those patients who attended a follow-up appointment were on average only Moderately Ill at baseline (CGI-S average of 3.9). Despite these follow patients not being severely mentally ill initially, the contact was helpful, as their CGI-S scores improved on average to the Mildly Ill range (CGI-S average of 2.8). A Mixed ANOVA revealed that there was a significant improvement in mental illness severity post-follow-up appointment (Greenhouse-Geisser .000). There was a near even proportion of males and females attending appointments (58% female), and slightly more females attended a follow-up (60% female). Males were on average more mentally ill at baseline compared to females at baseline (male average M=3.86, female average M=3.56), and males had a greater reduction in mental illness severity on average compared to females (male average M=2.71, female average 3.00). This was approaching significance (.073) and would be important to explore with a larger sample size. Change in clinical condition for follow-up patients was also recorded. It was found that more than half of patients (53%) were observed to experience Minimal improvement in attending at least one follow-up appointment. There was no change for 27% of patients, and there were no patients who were worse at follow up. As this was a preliminary study with small sample size, future research conducted could explore whether there are any significant gender differences, such as whether males experience the significantly greater reduction in symptoms of mental illness compared to females, as well as any effects of cancer stage or type on psychiatric outcomes. Future research could also investigate outcomes for those patients who concurrently access a Clinical Psychologist alongside the Psychiatrist. A limitation of the study is that the outcome measure is a brief item rating completed by the clinician.

Keywords: clinical global impressions scale, psychiatry, morbidity, oncology, outcomes, psychiatry

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Authors: Isa Usman Balan, Umar Aliyu, Ahmad Tijjani Muhammed

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The laboratory scale experiment was conducted to determine the phytochemical constituents and antibacterial activities of epiphytic neem leaves (Tapinanthusdodoneifolius) extracts on some selected clinical isolates. The samples were collected using polythene bags to avoid unnecessary contamination of the plants, and they were collected from the old site garden of the BUK. The phytochemical screening and antibacterial test were carried out in the Chemistry and Biology laboratory, respectively at Bayero University Kano (BUK). The result obtained showed that carbohydrates, glycosides, steroids, alkaloids, phenol, saponins and flavonoids are present in the ethanolic extract. However, chloroform extract showed only glycosides, phenols, and carbohydrates. Furthermore, there was no significant difference between the ethanolic extracts and bacterial isolates (p<0.05).

Keywords: phytochemical screening, antibacterial, clinical isolates, epiphytic neem leaves, Tapinanthus dodoneifolius

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Authors: Luziane De Fatima Kirchner, Maria De Jesus Dutra Dos Reis, Francine Nathalie Ferraresi Rodrigues Queluz

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This study evaluated the effect of two components of analytic-behavioral intervention (1-management of conditions of the physical environment, 2-management of the interpersonal relationship) of women with fibromyalgia (FM), besides Clinical Significance and Reliable Change at the end of the intervention. Self-report instruments were used to evaluate stress, anxiety, depression, social skills and disability due to pain and Cortisol Awakening Response (CAR). Four women with a medical diagnosis of FM (mean age 52.7; sd = 6.65), participated of the following procedures: initial evaluation, 10 sessions of component 1, intermediate evaluation, 10 sessions of component 2, and final evaluation. The 20 sessions were effective, with positive changes in the scores of all the self-report instruments, highlighting the results of the stress symptoms that had improvement in the intermediate evaluation. There was, however, no change in the cortisol response on awakening. The Clinical Significance or Reliable Change observed, according to the scores of the stress, anxiety, depression and social skills instruments, corroborated the reports of the participants in the session and the objectives of the treatment. Implications for future studies are discussed, above all, the importance in conducting evaluations with the use of direct measures together with self-report measures.

Keywords: behavioral intervention, clinical significance, fibromyalgia, reliable change

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Authors: Ramya Rathan, Miral N. F. Salama

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The variations in the arteries have been drawing attention of anatomists for a long time because of their clinical significance. The brachial artery is the principal artery of the arm which is the continuation of the axillary artery from the lower border of the Teres Major. It terminates into the radial and ulnar arteries below the elbow joint at the neck radius. The present study aims at exploring the clinical significance of the high termination of the brachial artery. During the routine cadaveric dissection of the arm, for the undergraduate students of medicine at our university, we observed a high bifurcation of the radial and the ulnar artery at the midshaft of the humerus. The median nerve was seen passing between these two junctions. Further, the course and the relations of this artery were studied. The accurate knowledge regarding these kinds of variation in the blood vessels is mandatory for planning of designing. General physicians, surgeons and radiologists should keep in mind the variations in the branching pattern of the arteries in their daily medical, diagnostic and therapeutic procedures to avoid complications in diagnostic and surgical procedures.

Keywords: brachial artery, high termination, radial artery, ulnar artery

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Authors: Lucile Rapin, Cynthia El Hage, Rihab Gamaoun, Maria-Fernanda Arboleda, Erin Prosk

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Introduction: Sante Cannabis (SC), a Canadian group of clinics dedicated to medical cannabis, based in Montreal and in the province of Quebec, has served more than 8000 patients seeking cannabis-based treatment over the past five years. As randomized clinical trials with natural medical cannabis are scarce, real-world evidence offers the opportunity to fill research gaps between scientific evidence and clinical practice. Data on the use of medical cannabis products from SC patients were prospectively collected, leading to a large real-world database on the use of medical cannabis. The aim of this study was to report information on the profiles of both patients and prescribed medical cannabis products at SC clinics, and to assess the safety of medical cannabis among Canadian patients. Methods: This is an observational retrospective study of 1342 adult patients who were authorized with medical cannabis products between October 2017 and September 2019. Information regarding demographic characteristics, therapeutic indications for medical cannabis use, patterns in dosing and dosage form of medical cannabis and adverse effects over one-year follow-up (initial and 4 follow-up (FUP) visits) were collected. Results: 59% of SC patients were female, with a mean age of 56.7 (SD= 15.6, range= (19-97)). Cannabis products were authorized mainly for patients with a diagnosis of chronic pain (68.8% of patients), cancer (6.7%), neurological disorders (5.6%), and mood disorders (5.4 %). At initial visit, a large majority (70%) of patients were authorized exclusively medical cannabis products, 27% were authorized a combination of pharmaceutical cannabinoids and medical cannabis and 3% were prescribed only pharmaceutical cannabinoids. This pattern was recurrent over the one-year follow-up. Overall, oil was the preferred formulation (average over visits 72.5%) followed by a combination of oil and dry (average 19%), other routes of administration accounted for less than 4%. Patients were predominantly prescribed products with a balanced THC:CBD ratio (59%-75% across visits). 28% of patients reported at least one adverse effect (AE) at the 3-month follow-up visit and 12% at the six-month FUP visit. 84.8% of total AEs were mild and transient. No serious AE was reported. Overall, the most common side effects reported were dizziness (11.95% of total AEs), drowsiness (11.4%), dry mouth (5.5%), nausea (4.8%), headaches (4.6%), cough (4.4%), anxiety (4.1%) and euphoria (3.5%). Other adverse effects accounted for less than 3% of total AE. Conclusion: Our results confirm that the primary area of clinical use for medical cannabis is in pain management. Patients in this cohort are largely utilizing plant-based cannabis oil products with a balanced ratio of THC:CBD. Reported adverse effects were mild and included dizziness and drowsiness. This real-world data confirms the tolerable safety profile of medical cannabis and suggests medical indications not yet validated in controlled clinical trials. Such data offers an important opportunity for the investigation of the long-term effects of cannabinoid exposure in real-life conditions. Real-world evidence can be used to direct clinical trial research efforts on specific indications and dosing patterns for product development.

Keywords: medical cannabis, safety, real-world data, Canada

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Authors: Promise Ufomadu, Edgar Rodriguez, Grace Lee

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Cutaneous Leishmaniasis (CL) is an infection caused by a variety of Leishmania species which are protozoan organisms that are typically carried by sandflies found in tropical regions. The parasite causes skin lesions that may resolve spontaneously but commonly become chronic and therefore necessitate thorough clinical attention. We present a 15-year-old female patient with CL of her bilateral dorsal hands, which resolved after a 28-day course of miltefosine. This case details the significance of compiling a thorough patient history and considering CL as a possible differential in patients from endemic regions.

Keywords: leishmaniasis, infection, immigrant, parasites, pediatrics

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Authors: Sireen Irsheid, Stephanie Keeney Parks, Michael A. Lindsey

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The medical and mental health field have been organized as reactive systems to respond to symptoms of mental health problems and disability. This becomes problematic particularly for those harmed by structural violence and racism, typically pushing us in the direction of alleviating symptoms and personalizing structural problems. The current paper examines how we assess, diagnose, and treat mental health and disability challenges in clinical spaces. We provide the readers with some context to think about the problem of racism and mental health/disability, ways to deconstruct the problem through the lens of structural violence, and recommendations to critically engage in clinical assessments, diagnosis, and treatment for young people impacted by structural violence and racism.

Keywords: mental health, disability, race and ethnicity, structural violence, structural racism, young people

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Authors: Jenyu Peng

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Incestuous abuse can be considered a form of domestic violence that exemplifies gender inequality. It challenges the common image of home as “haven of safety”. In Taiwan, even after years of feminist NGOs’ effort to encourage victims to speak up, the shared cultural representations of family, still praising piety towards the parents, seem to keep the incest trauma in secret. As clinical practitioners have observed, most devastating psychological sequels of incest trauma are often related to silencing. Thus one can expect that in families centered cultures, the difficulties for victims to disclose are greater, and the traumatic consequences more severe. This poses crucial therapeutic issues for clinicians working in those cultures. Since 2009, the author, a trained psychoanalyst and researcher, has been conducting “clinical fieldwork” on incest trauma in Taiwan. Employing ethnographical method, our theoretical references are both psychoanalytical and anthropological. The necessity of interdisciplinary efforts in incest trauma research will be addressed and discussed. The analyses of the present paper will focus on five incestuous families: four Han families, and one aboriginal. Although Taiwanese aboriginal peoples have been pretty much sinicized since decades, it is worth observing the convergent and divergent aspects in these two cultures. Moreover, findings of a previous research conducted in France during 2002-2004 will serve as background for the purpose of comparison. The results will be presented along with three questions: 1) How the perception of family influences the process of disclosure? 2) How the incestuous experience comes into play with victims’ gender identity and sexuality, pivotal for the subjectification? 3) How victims more successful in gendered subjectification modify their dynamics with their traumatizing family? This research finds that most victims tend to defend their own incestuous families, and that victims’ subjectivity and agency are actually entangled in the power structure of incestuous family.

Keywords: incestuous family, subjectification, gender identity, agency

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Authors: Nasreen Basoudan, Andrea Tales, Frederic Boy

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Non-clinical anxiety may be comprised of state anxiety - temporarily experienced anxiety related to a specific situation, and trait anxiety - a longer lasting response or a general disposition to anxiety. While temporary and occasional anxiety whether as a mood state or personality dimension is normal, nonclinical anxiety may influence many more components of information processing than previously recognized. In ageing and dementia-related research, disease characterization now involves attempts to understand a much wider range of brain function such as loss of inhibitory control, as against the more common focus on memory and cognition. However, in many studies, the tendency has been to include individuals with clinical anxiety disorders while excluding persons with lower levels of state or trait anxiety. Loss of inhibitory cognitive control can lead to behaviors such as aggression, reduced sensitivity to others, sociopathic thoughts and actions. Anxiety has also been linked to inhibitory control, with research suggesting that people with anxiety are less capable of inhibiting their emotions than the average person. This study investigates the relationship between anxiety and loss of inhibitory control in younger and older adults, using a variety of questionnaires and computers-based tests. Based on the premise that irrespective of classification, anxiety is associated with a wide range of physical, affective, and cognitive responses, this study explores evidence indicative of the potential influence anxiety per se on loss of inhibitory control, in order to contribute to discussion and appropriate consideration of anxiety-related factors in methodological practice.

Keywords: anxiety, ageing, dementia, inhibitory control

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Authors: Bill D. Geis

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

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

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Authors: Olayinka Risiquat Raimi

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FOS was produced from FTase of Aspergillus niger. HPLC analysis showed 32.24%. Consisting of 28.57% ketose and 4.67% nystose. Effects of FOS were studied on 12 weeks old albino rats. All animals survived until scheduled euthanasia. A low incidence of clinical sign and no toxicological effect were observed. Male rats fed with 2500mg/kg fructooligosaccharides had the highest weight. Male and female rat showed a significant increase in weight from first week to the fifth week. All haematological parameters examined were normal in male and female rats. Mean haematological and haemoglobin values for 2500mg/kg bw FOS fed male rats were the highest. Clinical chemistry test, glucose, albumin, and cholesterol were within normal laboratory values for a rat. The mean glucose value was lower for FOS fed male and female rats compared to those fed with honey and 60% sucrose. Gross necropsy observation showed no remarkable internal gross abnormalities for any of the animals.

Keywords: fructooligosaccharide, white albino rat, haematology values, clinical chemistry values

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Authors: Omer Ibrahim Abdallh Omer

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Cancer patients often face complex medication regimens, leading to challenges in treatment adherence and clinical outcomes. Pharmacist-led medication therapy management (MTM) has emerged as a potential solution to optimize medication use and improve patient outcomes in oncology settings. In this prospective intervention study, we aimed to evaluate the impact of pharmacist-led MTM on treatment adherence and clinical outcomes among cancer patients. Participants were randomized to receive either pharmacist-led MTM or standard care, with assessments conducted at baseline and follow-up visits. Pharmacist interventions included medication reconciliation, adherence counseling, and personalized care plans. Our findings reveal that pharmacist-led MTM significantly improved medication adherence rates and clinical outcomes compared to standard care. Patients receiving pharmacist interventions reported higher satisfaction levels and perceived value in pharmacist involvement in their cancer care. These results underscore the critical role of pharmacists in optimizing medication therapy and enhancing patient-centered care in oncology settings. Integration of pharmacist-led MTM into routine cancer care pathways holds promise for improving treatment outcomes and quality of life for cancer patients.

Keywords: cancer, medications adherence, medication therapy management, pharmacist

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Authors: Mahdi Asghari Ozma, Fatemeh Aghamohammadzadeh, Mahin Ahangar Oskouee

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In late 2019, the people of the world were involved with a new infection by the coronavirus, named SARS-COV-2 (COVID-19), which disseminated around the world quickly. This infection has the ability to affect various systems of the body, including respiratory, gastrointestinal, urinary, and hematology, which can be transmitted by various body samples in different ways. To control this fast-transmitted infection by preventing its transmission to other people, rapid diagnosis is vital, which can be done by examining the patient's clinical symptoms and also using various serological, molecular, and radiological methods. Symptoms caused by COVID-19 in patients include fever, cough, sore throat, headache, fatigue, shortness of breath, loss of taste or smell, skin rash, myalgia, and conjunctivitis. These clinical features were appearing gradually in different time periods from the onset of the infection, and patients showed varied and new symptoms at different times, which show the variety of symptoms over time during the spread of the infection.

Keywords: COVID-19, diagnosis, symptom, variation, novel coronavirus

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Authors: Matthieu-P. Schapranow

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Recruitment of participants for clinical trials requires the screening of a big number of potential candidates, i.e. the testing for trial-specific inclusion and exclusion criteria, which is a time-consuming and complex task. Today, a significant amount of time is spent on identification of adequate trial participants as their selection may affect the overall study results. We introduce a unique patient eligibility metric, which allows systematic ranking and classification of candidates based on trial-specific filter criteria. Our web application enables real-time analysis of patient data and assessment of candidates using freely definable inclusion and exclusion criteria. As a result, the overall time required for identifying eligible candidates is tremendously reduced whilst additional degrees of freedom for evaluating the relevance of individual candidates are introduced by our contribution.

Keywords: in-memory technology, clinical trials, screening, eligibility metric, data analysis, clustering

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Authors: Doroteya K. Staykova, Dirk J. Lefeber, Sabine A. Fuchs, Judith J. M. Jans

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Cholestasis is characterized by the accumulation of toxic bile salts and lipids in the organism. The variety in causes (genetic, immunologic, environmental) and nature (benign, transient, chronic, progressive) combined with the need for early diagnosis and rapid clinical decisions emphasizes the need for good diagnostic strategies to improve patient outcomes. In a current diagnostic analysis of cholestasis, mass-spectrometry metabolomics is a widely adopted tool to enhance clinical decisions at point-of-care, thanks to a short turnaround in measurement times while performing comprehensive molecular profiling of patient material. However, this comes at the cost of difficult-to-identify yet actionable knowledge, often buried within large and heterogenous omics data. Here, we demonstrate how topological data analysis can overcome this challenge in large metabolomics datasets of patients with twenty categories of Metabolic Disorders and overlapping clinical manifestations. To elucidate the complexity of disease progression in three cholestasis patients, we applied topological data analysis to direct-infusion mass spectrometry data collected from 190 plasma samples, including 67 controls, at the University Medical Center in Utrecht, Netherlands. Using the Mapper algorithm and filter function defined as a two-component projection based on Principal Component Analysis, we constructed a topological graph of connected patients, termed a Patient Connectivity Network (PCN). With incorporated clinical and molecular information, PCN revealed the topological shape of causes and severity of cholestasis and transitions in patients’ conditions. In conclusion, topology based PCN provides a holistic view of cholestasis state dynamics that has the potential to support and expedite clinical decisions.

Keywords: mass spectrometry-based metabolomics, patient connectivity network, topological data analysis, unmet clinical needs in Cholestasis

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Authors: Lazzat M. Zhamaliyeva, Nurgul A. Abenova, Gauhar S. Dilmagambetova, Ziyash Zh. Tanbetova, Moldir B. Ahmetzhanova, Tatyana P. Ostretcova, Aliya A. Yegemberdiyeva

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Introduction: There are many reasons for the weak training of family doctors in Kazakhstan: the unified national educational program is not focused on competencies, the role of a general practitioner (GP) is not clear, poor funding for the health care and education system, outdated teaching and assessment methods, inefficient management. We highlight two issues in particular. Firstly, academic teachers of family medicine (FM) in Kazakhstan do not practice as family doctors; most of them are narrow specialists (pediatricians, therapists, surgeons, etc.); they usually hold one-time consultations; clinical mentors from practical healthcare (non-academic teachers) do not have the teaching competences, and the vast majority of them are also narrow specialists. Secondly, clinical sites (polyclinics) are unprepared for general practice and do not follow the principles of family medicine; residents do not like to be in primary health care (PHC) settings due to the chaos that is happening there, as well as due to the lack of the necessary equipment for mastering and consolidating practical skills. Aim: We present the concept of the family physicians’ training office (FPTO), which is being created as a friendly learning environment for young general practitioners and for the involvement of academic teachers of family medicine in the practical work and innovative development of PHC. Methodology: In developing the conceptual framework and identifying practical activities, we drew on literature and expert input, and interviews. Results: The goal of the FPTO is to create a favorable educational and clinical environment for the development of the FM residents’ competencies, in which the residents with academic teachers and clinical mentors could understand and accept the principles of family medicine, improve clinical knowledge and skills, and gain experience in improving the quality of their practice in scientific basis. Three main areas of office activity are providing primary care to the patients, improving educational services for FM residents and other medical workers, and promoting research in PHC and innovations. The office arranges for residents to see outpatients at least 50% of the time, and teachers of FM departments at least 1/4 of their working time conduct general medical appointments next to residents. Taking into account the educational and scientific workload, the number of attached population for one GP does not exceed 500 persons. The equipment of the office allows FPTO workers to perform invasive and other manipulations without being sent to other clinics. In the office, training for residents is focused on their needs and aimed at achieving the required level of competence. International methodologies and assessment tools are adapted to local conditions and evaluated for their effectiveness and acceptability. Residents and their faculty actively conduct research in the field of family medicine. Conclusions: We propose to change the learning environment in order to create teams of like-minded people, to unite residents and teachers even more for the development of family medicine. The offices will also invest resources in developing and maintaining young doctors' interest in family medicine.

Keywords: educational environment, family medicine residents, family physicians’ training office, primary care research

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Authors: Atiqah Binti Ab Aziz

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Background: It has been estimated that about 250 million people all over the world suffer from osteoarthritis (OA). Thus, OA is a major health problem in urgent need of better treatment. Problem statement: Current therapies for OA can temporarily relieve clinical symptoms and for pain management, rather than preventing or curing OA. Total knee replacement performed at the end stage of the disease is considered the only cure available. Objectives: This article aimed to explore the potential of treating osteoarthritis via the CRISPR Cas system. Methods: Articles that relate to the application of the CRISPR Cas system in osteoarthritis were extracted, categorized, and reviewed through the PRISMA method using PubMed, an engine published from November 2016 to November 2021. Results: There were 30 articles screened. Articles that fall under the categories of non-English articles, full articles that were not available, articles that were not an original articles were excluded. Ultimately, 13 articles were reviewed. Discussion: This review provides an information on the introduction of CRISPR and discussed on their mechanism of actions in extracted studies for OA treatment. Conclusions: It can be seen that not many medical research utilize the CRISPR Cas system as part of the method in the treatment of OA. Hence exploring the extent of the usage of the CRISPR Cas system in OA treatment is important to determine the research gap and point out at which of the research is needed further investigation to avoid redundancy of existing research and ensure the novelty of the research.

Keywords: osteoarthritis, treatment, CRISPR, review, therapy

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Authors: Hannah K. M. Tang, Muhammad Ateeq, Mark J. Lake, Badr Abdullah, Frederic A. Bezombes

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There is little research applying virtual reality (VR) to the treatment of musculoskeletal injury in athletes. This is despite their prevalence, and the implications for physical and psychological health. Nevertheless, developments of wireless VR headsets better facilitate dynamic movement in VR environments (VREs), and more research is expected in this emerging field. This systematic review identified publications that used VR interventions for the analysis or treatment of lower-limb musculoskeletal injury of athletes. It established a search protocol, and through narrative discussion, identified existing trends. Database searches encompassed four term sets: 1) VR systems; 2) musculoskeletal injuries; 3) sporting population; 4) movement outcome analysis. Overall, a total of 126 publications were identified through database searching, and twelve were included in the final analysis and discussion. Many of the studies were pilot and proof of concept work. Seven of the twelve publications were observational studies. However, this may provide preliminary data from which clinical trials will branch. If specified, the focus of the literature was very narrow, with very similar population demographics and injuries. The trends in the literature findings emphasised the role of VR and attentional focus, the strategic manipulation of movement outcomes, and the transfer of skill to the real-world. Causal inferences may have been undermined by flaws, as most studies were limited by the practicality of conducting a two-factor clinical-VR-based study. In conclusion, by assessing the exploratory studies, and combining this with the use of numerous developments, techniques, and tools, a novel application could be established to utilise VR with dynamic movement, for the effective treatment of specific musculoskeletal injuries of athletes.

Keywords: athletes, lower-limb musculoskeletal injury, rehabilitation, return-to-sport, virtual reality

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Authors: Zhipeng Yan, Janice Wing-Tung Kwong, Ching-Lung Lai

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Background: Advanced melanoma accounts for the majority of skin cancer death due to its poor prognosis. Nivolumab and ipilimumab are monoclonal antibodies targeting programmed cell death protein 1 (PD-1) and cytotoxic T-lymphocytes antigen 4 (CTLA-4). Nivolumab and ipilimumab combination therapy has been proven to be effective for advanced melanoma. This systematic review and meta-analysis are to evaluate its clinical efficacy and adverse events. Method: A systematic search was done on databases (Pubmed, Embase, Medline, Cochrane) on 21 June 2020. Search keywords were nivolumab, ipilimumab, melanoma, and randomised controlled trials. Clinical trials fulfilling the inclusion criteria were selected to evaluate the efficacy of combination therapy in terms of prolongation of progression-free survival (PFS), overall survival (OS), and objective response rate (ORR). The odd ratios and distributions of grade 3 or above adverse events were documented. Subgroup analysis was performed based on PD-L1 expression-status and BRAF-mutation status. Results: Compared with nivolumab monotherapy, the hazard ratios of PFS, OS and odd ratio of ORR in combination therapy were 0.64 (95% CI, 0.48-0.85; p=0.002), 0.84 (95% CI, 0.74-0.95; p=0.007) and 1.76 (95% CI, 1.51-2.06; p < 0.001), respectively. Compared with ipilimumab monotherapy, the hazard ratios of PFS, OS and odd ratio of ORR were 0.46 (95% CI, 0.37-0.57; p < 0.001), 0.54 (95% CI, 0.48-0.61; p < 0.001) and 6.18 (95% CI, 5.19-7.36; p < 0.001), respectively. In combination therapy, the odds ratios of grade 3 or above adverse events were 4.71 (95% CI, 3.57-6.22; p < 0.001) compared with nivolumab monotherapy, and 3.44 (95% CI, 2.49-4.74; p < 0.001) compared with ipilimumab monotherapy, respectively. High PD-L1 expression level and BRAF mutation were associated with better clinical outcomes in patients receiving combination therapy. Conclusion: Combination therapy is effective for the treatment of advanced melanoma. Adverse events were common but manageable. Better clinical outcomes were observed in patients with high PD-L1 expression levels and positive BRAF-mutation.

Keywords: nivolumab, ipilimumab, advanced melanoma, systematic review, meta-analysis

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Authors: Joyce K. Anastasi, Bernadette Capili

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Community Engagement Strategies to Assist with the Development of an RCT Among People Living with HIV Our research team focuses on developing and testing protocols to manage chronic symptoms. For many years, our team designed and implemented symptom management studies for people living with HIV (PLWH). We identify symptoms that are not curative and are not adequately controlled by conventional therapies. As an exemplar, we describe how we successfully engaged PLWH in developing and refining our research feasibility protocol for distal sensory peripheral neuropathy (DSP) associated with HIV. With input from PLWH with DSP, our research received National Institutes of Health (NIH) research funding support. Significance: DSP is one of the most common neurologic complications in HIV. It is estimated that DSP affects 21% to 50% of PLWH. The pathogenesis of DSP in HIV is complex and unclear. Proposed mechanisms include cytokine dysregulation, viral protein-produced neurotoxicity, and mitochondrial dysfunction associated with antiretroviral medications. There are no FDA-approved treatments for DSP in HIV. Purpose: Aims: 1) to explore the impact of DSP on the lives of PLWH, 2) to identify patients’ perspectives on successful treatments for DSP, 3) to identify interventions considered feasible and sensitive to the needs of PLWH with DSP, and 4) to obtain participant input for protocol/study design. Description of Process: We conducted a needs assessment with PLWH with DSP. From our needs assessment, we learned from the patients’ perspective detailed descriptions of their symptoms; physical functioning with DSP; self-care remedies tried, and desired interventions. We also asked about protocol scheduling, instrument clarity, study compensation, study-related burdens, and willingness to participate in a randomized controlled trial (RCT) with a placebo and a waitlist group. Implications: We incorporated many of the suggestions learned from the need assessment. We developed and completed a feasibility study that provided us with invaluable information that informed subsequent NIH-funded studies. In addition to our extensive clinical and research experience working with PLWH, learning from the patient perspective helped in developing our protocol and promoting a successful plan for recruitment and retention of study participants.

Keywords: clinical trial development, peripheral neuropathy, traditional medicine, HIV, AIDS

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Authors: Rosemary Saunders, Courtney Glass, Karla Seaman, Karen Gullick, Julie Andrew, Anne Wilkinson, Ashwini Davray

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Current literature demonstrates that most Australians receive end-of-life care in a hospital setting, despite most hoping to die within their own home. The necessity for high quality end-of-life care has been emphasised by the Australian Commission on Safety and Quality in Health Care and the National Safety and Quality in Health Services Standards depict the requirement for comprehensive care at the end of life (Action 5.20), reinforcing the obligation for continual organisational assessment to determine if these standards are suitably achieved. Limited research exploring clinical staff perspectives of end-of-life care delivery has been conducted within an Australian private health context. This study aimed to investigate clinical staff member perceptions of end-of-life care delivery at a private hospital in Western Australia. The study comprised of a multi-faceted mixed-methods methodology, part of a larger study. Data was obtained from clinical staff utilising surveys and focus groups. A total of 133 questionnaires were completed by clinical staff, including registered nurses (61.4%), enrolled nurses (22.7%), allied health professionals (9.9%), non-palliative care consultants (3.8%) and junior doctors (2.2%). A total of 14.7% of respondents were palliative care ward staff members. Additionally, seven staff focus groups were conducted with physicians (n=3), nurses (n=26) and allied health professionals including social workers (n=1), dietitians (n=2), physiotherapists (n=5) and speech pathologists (n=3). Key findings from the surveys highlighted that the majority of staff agreed it was part of their role to talk to doctors about the care of patients who they thought may be dying, and recognised the importance of communication, appropriate training and support for clinical staff to provide quality end-of-life care. Thematic analysis of the qualitative data generated three key themes: creating the setting which highlighted the importance of adequate resourcing and conducive physical environments for end-of-life care and to support staff and families; planning and care delivery which emphasised the necessity for collaboration between staff, families and patients to develop care plans and treatment directives; and collaborating in end-of-life care, with effective communication and teamwork leading to achievable care delivery expectations. These findings contribute to health professionals better understanding of end-of-life care provision and the importance of collaborating with patients and families in care delivery. It is crucial that health care providers implement strategies to overcome gaps in care, so quality end-of-life care is provided. Findings from this study have been translated into practice, with the development and implementation of resources, training opportunities, support networks and guidelines for the delivery of quality end-of-life care.

Keywords: clinical staff, end-of-life care, mixed-methods, private hospital.

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Authors: Shalini Tripathi, Pardeep Kumar

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The method of translating observed symptoms into disease names is known as disease diagnosis. The ability to solve clinical problems in a complex manner is critical to a doctor's effectiveness in providing health care. The accuracy of his or her expertise is crucial to the survival and well-being of his or her patients. Artificial Intelligence (AI) has a huge economic influence depending on how well it is applied. In the medical sector, human brain-simulated intellect can help not only with classification accuracy, but also with reducing diagnostic time, cost and pain associated with pathologies tests. In light of AI's present and prospective applications in the biomedical, we will identify them in the paper based on potential benefits and risks, social and ethical consequences and issues that might be contentious but have not been thoroughly discussed in publications and literature. Current apps, personal tracking tools, genetic tests and editing programmes, customizable models, web environments, virtual reality (VR) technologies and surgical robotics will all be investigated in this study. While AI holds a lot of potential in medical diagnostics, it is still a very new method, and many clinicians are uncertain about its reliability, specificity and how it can be integrated into clinical practice without jeopardising clinical expertise. To validate their effectiveness, more systemic refinement of these implementations, as well as training of physicians and healthcare facilities on how to effectively incorporate these strategies into clinical practice, will be needed.

Keywords: Artificial Intelligence, medical diagnosis, virtual reality, healthcare ethical implications 

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Authors: T. Rocha, P. Carvalho, S. Paredes, J. Henriques, A. Bianchi, V. Traver, A. Martinez

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The main goal of LINK project is to join competences in intelligent processing in order to create a research ecosystem to address two central scientific and technical challenges for personal health care (PHC) deployment: i) how to merge clinical evidence knowledge in computational decision support systems for PHC management and ii) how to provide achieve personalized services, i.e., solutions adapted to the specific user needs and characteristics. The final goal of one of the work packages (WP2), designated Sustainable Linking and Synergies for Excellence, is the definition, implementation and coordination of the necessary activities to create and to strengthen durable links between the LiNK partners. This work focuses on the strategy that has been followed to achieve the definition of the Research Tracks (RT), which will support a set of actions to be pursued along the LiNK project. These include common research activities, knowledge transfer among the researchers of the consortium, and PhD student and post-doc co-advisement. Moreover, the RTs will establish the basis for the definition of concepts and their evolution to project proposals.

Keywords: LiNK Twin European Project, personal health care, cardiovascular diseases, research tracks

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Authors: Suchana Marahatta, Sabina Bhattarai, Bishnu Hari Paudel, Dilip Thakur

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Background: Every year thousands of patients develop nerve damage and disabilities as a result of leprosy which can be prevented by early detection and treatment. So, early detection and treatment of nerve function impairment is of paramount importance in leprosy. Objectives: To assess the electrophysiological pattern of the peripheral nerves in leprosy patients and to compare it with clinical assessment tools. Materials and Methods: In this comparative cross-sectional study, 74 newly diagnosed leprosy patients without reaction were enrolled. They underwent thorough evaluation for peripheral nerve function impairment using clinical tests [i.e. nerve palpation (NP), monofilament (MF) testing, voluntary muscle testing (VMT)] and nerve conduction study (NCS). Clinical findings were compared with that of NCS using SPSS version 11.5. Results: NCS was impaired in 43.24% of leprosy patient at the baseline. Among them, sensory NCS was impaired in more patients (32.4%) in comparison to motor NCS (20.3%). NP, MF, and VMT were impaired in 58.1%, 25.7%, and 9.4% of the patients, respectively. Maximum concordance of monofilament testing and sensory NCS was found for sural nerve (14.7%). Likewise, the concordance of motor NP and motor NCS was the maximum for ulnar nerve (14.9%). When individual parameters of the NCS were considered, amplitude was found to be the most frequently affected parameter for both sensory and motor NCS. It was impaired in 100% of cases with abnormal NCS findings. Conclusion: Since there was no acceptable concordance between NCS findings and clinical findings, we should consider NCS whenever feasible for early detection of neuropathy in leprosy. The amplitude of both sensory nerve action potential (SNAP) and compound nerve action potential (CAMP) could be important determinants of the abnormal NCS if supported by further studies.

Keywords: leprosy, nerve function impairment, neuropathy, nerve conduction study

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Authors: Michael Zhang, Nicholas Marriage, Valerie Astle, Marie-Louise Ratican, Jonathan Ash, Haddijatou Hughes

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Objective: Young infants are often brought to the Emergency Department (ED) with a variety of complaints, some of them are non-specific and present as a diagnostic challenge to the attending clinician. Whilst invasive investigations such as blood tests and lumbar puncture are necessary in some cases to exclude serious infections, some basic clinical tools in additional to thorough clinical history can be useful to assess the risks of serious conditions in these young infants. This study aimed to examine the utilization of one of clinical tools in this regard. Methods: This retrospective observational study examined the medical records of infants under 6 months presenting to a mixed urban ED between January 2013 and December 2014. The infants deemed to have non-specific complaints or diagnoses by the emergency clinicians were selected for analysis. The ones with clear systemic diagnoses were excluded. Among all relevant clinical information and investigation results, utilization of Standard Paediatric Observation Chart (SPOC) was particularly scrutinized in these medical records. This specific chart was developed by the expert clinicians in local health department. It categorizes important clinical signs into some color-coded zones as a visual cue for serious implication of some abnormalities. An infant is regarded as SPOC positive when fulfills 1 red zone or 2 yellow zones criteria, and the attending clinician would be prompted to investigate and treat for potential serious conditions accordingly. Results: Eight hundred and thirty-five infants met the inclusion criteria for this project. The ones admitted to the hospital for further management were more likely to have SPOC positive criteria than the discharged infants (Odds ratio: 12.26, 95% CI: 8.04 – 18.69). Similarly, Sepsis alert criteria on SPOC were positive in a higher percentage of patients with serious infections (56.52%) in comparison to those with mild conditions (15.89%) (p < 0.001). The SPOC sepsis criteria had a sensitivity of 56.5% (95% CI: 47.0% - 65.7%) and a moderate specificity of 84.1% (95% CI: 80.8% - 87.0%) to identify serious infections. Applying to this infant population, with a 17.4% prevalence of serious infection, the positive predictive value was only 42.8% (95% CI: 36.9% - 49.0%). However, the negative predictive value was high at 90.2% (95% CI: 88.1% - 91.9%). Conclusions: Standard Paediatric Observation Chart has been applied as a useful clinical tool in the clinical practice to help identify and manage young sick infants in ED effectively.

Keywords: clinical tool, infants, non-specific complaints, Standard Paediatric Observation Chart

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Authors: Gulcan Sahal, Nermin Hande Avcioglu, Isil Seyis Bilkay

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Klebsiella species which are natural colonizers of human upper respiratory and human gastrointestinal tracts are also responsible for every reoccurring nosocomial infections by means of having ability to form slimy layers known as biofilm on many surfaces. Therefore, in this study, investigation of biofilm formation in K. pneumoniae and K. rhinoscleromatis and examination of each Klebsiella strains’ clinical information in the light of their biofilm formation results were aimed. In this respect, biofilm formation of Klebsiella strains was analyzed via crystal violet binding assay. According to our results, biofilm formation levels of K. pneumoniae and K. rhinoscleromatis strains were different from each other. Additionally, in comparison to K. rhinoscleromatis strains, K. pneumoniae was observed to include higher amounts of strong biofilm forming strains. Besides, it was also seen that clinical information of patients from which strong biofilm forming Klebsiella strains were isolated were similar to each other. Our results indicate that there should be more precautions against K. pneumoniae which includes higher amount of strong biofilm forming strains.

Keywords: biofilm formation, Klebsiella pneumoniae, Klebsiella rhinoscleromatis, biosystems engineering

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Authors: Recep Keşli, Gülşah Aşık, Cengiz Demir, Onur Türkyılmaz

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Objective: Serratia species are identified as aerobic, motile Gram negative rods. The species Serratia marcescens (S. marcescens) causes both opportunistic and nosocomial infections. The genus Providencia is Gram-negative bacilli and includes urease-producing that is responsible for a wide range of human infections. Although most Providencia infections involve the urinary tract, they are also associated with gastroenteritis, wound infections, and bacteremia. The aim of this study was evaluate the antimicrobial resistance rates of S. marcescens and Providencia spp. strains which had been isolated from various clinical materials obtained from different patients who belongs to intensive care units (ICU) and inpatient clinics. Methods: A total of 35 S. marcescens and Providencia spp. strains isolated from various clinical samples admitted to Medical Microbiology Laboratory, ANS Research and Practice Hospital, Afyon Kocatepe University between October 2013 and September 2015 were included in the study. Identification of the bacteria was determined by conventional methods and VITEK 2 system (bio-Merieux, Marcy l’etoile, France) was used additionally. Antibacterial resistance tests were performed by using Kirby Bauer disc (Oxoid, Hampshire, England) diffusion method following the recommendations of CLSI. Results: The distribution of clinical samples were as follows: upper and lower respiratory tract samples 26, 74.2 % wound specimen 6, 17.1 % blood cultures 3, 8.5%. Of the 35 S. marcescens and Providencia spp. strains; 28, 80% were isolated from clinical samples sent from ICU. The resistance rates of S. marcescens strains against trimethoprim-sulfamethoxazole, piperacillin-tazobactam, imipenem, gentamicin, ciprofloxacin, ceftazidime, cefepime and amikacin were found to be 8.5 %, 22.8 %, 11.4 %, 2.8 %, 17.1 %, 40 %, 28.5 % and 5.7 % respectively. Resistance rates of Providencia spp. strains against trimethoprim-sulfamethoxazole, piperacillin-tazobactam, imipenem, gentamicin, ciprofloxacin, ceftazidime, cefepime and amikacin were found to be 10.2 %, 33,3 %, 18.7 %, 8.7 %, 13.2 %, 38.6 %, 26.7%, and 11.8 % respectively. Conclusion: S. marcescens is usually resistant to ampicillin, amoxicillin, amoxicillin/clavulanate, ampicillin/sulbactam, cefuroxime, cephamycins, nitrofurantoin, and colistin. The most effective antibiotic on the total of S. marcescens strains was found to be gentamicin 2.8 %, of the totally tested strains the highest resistance rate found against to ceftazidime 40 %. The lowest and highest resistance rates were found against gentamiycin and ceftazidime with the rates of 8.7 % and 38.6 % for Providencia spp.

Keywords: Serratia marcescens, Providencia spp., antibiotic resistance, intensive care unit

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