Search results for: patient reported symptom burden
Commenced in January 2007
Frequency: Monthly
Edition: International
Paper Count: 7402

Search results for: patient reported symptom burden

6832 Leptospira Lipl32-Specific Antibodies: Therapeutic Property, Epitopes Characterization and Molecular Mechanisms of Neutralization

Authors: Santi Maneewatchararangsri, Wanpen Chaicumpa, Patcharin Saengjaruk, Urai Chaisri

Abstract:

Leptospirosis is a globally neglected disease that continues to be a significant public health and veterinary burden, with millions of cases reported each year. Early and accurate differential diagnosis of leptospirosis from other febrile illnesses and the development of a broad spectrum of leptospirosis vaccines are needed. The LipL32 outer membrane lipoprotein is a member of Leptospira adhesive matrices and has been found to exert hemolytic activity to erythrocytes in vitro. Therefore, LipL32 is regarded as a potential target for diagnosis, broad-spectrum leptospirosis vaccines, and for passive immunotherapy. In this study, we established LipL32-specific mouse monoclonal antibodies, mAbLPF1 and mAbLPF2, and their respective mouse- and humanized-engineered single chain variable fragment (ScFv). Their antibodies’ neutralizing activities against Leptospira-mediated hemolysis in vitro, and the therapeutic efficacy of mAbs against heterologous Leptospira infected hamsters were demonstrated. The epitope peptide of mAb LPF1 was mapped to a non-contiguous carboxy-terminal β-turn and amphipathic α-helix of LipL32 structure contributing to phospholipid/host cell adhesion and membrane insertion. We found that the mAbLPF2 epitope was located on the interacting loop of peptide binding groove of the LipL32 molecule responsible for interactions with host constituents. Epitope sequences are highly conserved among Leptospira spp. and are absent from the LipL32 superfamily of other microorganisms. Both epitopes are surface-exposed, readily accessible by mAbs, and immunogenic. However, they are less dominant when revealed by LipL32-specific immunoglobulins from leptospirosis-patient sera and rabbit hyperimmune serum raised by whole Leptospira. Our study also demonstrated an adhesion inhibitory activity of LipL32 protein to host membrane components and cells mediated by mAbs as well as an anti-hemolytic activity of the respective antibodies. The therapeutic antibodies, particularly the humanized-ScFv, have a potential for further development as non-drug therapeutic agent for human leptospirosis, especially in subjects allergic to antibiotics. The epitope peptides recognized by two therapeutic mAbs have potential use as tools for structure-function studies. Finally, protective peptides may be used as a target for epitope-based vaccines for control of leptospirosis.

Keywords: leptospira lipl32-specific antibodies, therapeutic epitopes, epitopes characterization, immunotherapy

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6831 Unexpected Acute Respiratory Failure following Administration of Rocuronium Bromide during Cesarean Delivery in a Severely Preeclamptic Parturient Treated with Magnesium Sulfate

Authors: Joseph Carl Macalintal, Erlinda Armovit

Abstract:

Magnesium sulfate has been a mainstay in the management of preeclampsia and is associated with a decreased incidence of morbidity and mortality. The syndrome has an unpredictable course, sometimes rapidly evolving to full-blown disease. In patients with deteriorating status, it is indicated to terminate the pregnancy via cesarean section. The anesthesiologists would prefer to have the procedure done under regional anesthesia; however, there may be cases when neuraxial anesthesia is contraindicated, or a general anesthesia would permit prompt delivery of the fetus. A patient with severe preeclampsia was given magnesium sulfate intrapartum, wherein a primary cesarean section was indicated for arrest in cervical dilatation, and was performed under general anesthesia. The patient developed acute respiratory failure and the causes of this occurrence were investigated in this report. It was later found out that neither the hypermagnesemia nor the muscle relaxant alone caused the patient’s condition but the interaction between the two. The patient was managed expectantly at the intensive care unit (ICU) and was eventually extubated during the 1st post-operative day. Knowledge of this drug interaction would allow obstetricians to advise their patients and their family about the possibility of prolonged intubation and ICU admission. This would also bring to the anesthesiologists’ attention the need to decrease the dose of muscle relaxant and to prepare drugs for immediate decurarisation.

Keywords: eclampsia, magnesium sulfate, preeclampsia, rocuronium bromide

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6830 A Rare Case of Acquired Benign Tracheoesophageal Fistula: Case Report and Literature Review

Authors: Sarah Bouayyad, Ajay Nigam, Meera Beena

Abstract:

Acquired benign tracheoesophageal fistula is a rare medical condition that usually results from trauma, foreign bodies, or granulomatous infections. This is an unusual presentation of a male patient with a history of laryngectomy who had had over a period of several years inappropriately and vigorously used valve cleaning brushes to clean tracheal secretions, which had led to the formation of a tracheoesophageal fistula. Due to the patient’s obsessive habit, we couldn’t manage him using conventional surgical methods. Instead, we opted for the placement of a salivary bypass tube, which yielded good results and recovery. To the best of our knowledge, no other case of similar etiology has been published. We would like to highlight the importance of appropriate patient selection and education prior to performing a tracheoesophageal puncture to avoid developing life-threatening complications as demonstrated in our case report.

Keywords: tracheoesophageal fistula, speech valve, endoscopic insertion of salivary bypass tube, head and neck malignancies

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6829 Description of Reported Foodborne Diseases in Selected Communities within the Greater Accra Region-Ghana: Epidemiological Review of Surveillance Data

Authors: Benjamin Osei-Tutu, Henrietta Awewole Kolson

Abstract:

Background: Acute gastroenteritis is one of the frequently reported Out-Patient Department (OPD) cases. However, the causative pathogens of these cases are rarely identified at the OPD due to delay in laboratory results or failure to obtain specimens before antibiotics is administered. Method: A retrospective review of surveillance data from the Adentan Municipality, Accra, Ghana that were recorded in the National foodborne disease surveillance system of Ghana, was conducted with the main aim of describing the epidemiology and food practice of cases reported from the Adentan Municipality. The study involved a retrospective review of surveillance data kept on patients who visited health facilities that are involved in foodborne disease surveillance in Ghana, from January 2015 to December 2016. Results: A total of 375 cases were reviewed and these were classified as viral hepatitis (hepatitis A and E), cholera (Vibrio cholerae), dysentery (Shigella sp.), typhoid fever (Salmonella sp.) or gastroenteritis. Cases recorded were all suspected case and the average cases recorded per week was 3. Typhoid fever and dysentery were the two main clinically diagnosed foodborne illnesses. The highest number of cases were observed during the late dry season (Feb to April), which marks the end of the dry season and the beginning of the rainy season. Relatively high number of cases was also observed during the late wet seasons (Jul to Oct) when the rainfall is the heaviest. Home-made food and street vended food were the major sources of suspected etiological food, recording 49.01% and 34.87% of the cases respectively. Conclusion: Majority of cases recorded were classified as gastroenteritis due to the absence of laboratory confirmation. Few cases were classified as typhoid fever and dysentery based on clinical symptoms presented. Patients reporting with foodborne diseases were found to consume home meal and street vended foods as their predominant source of food.

Keywords: accra, etiologic food, food poisoning, gastroenteritis, illness, surveillance

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6828 Differentiated Thyroid Cancer Presenting with Solitary Bony Metastases to the Frontal Bone of the Skull

Authors: Christy M. Moen, Richard B. Townsley

Abstract:

Introduction: Metastasis to the frontal bone in thyroid cancer is extremely rare. A literature review found only six cases of thyroid cancer that metastasised to the frontal bone, with two of those involving further bone sites. Case Report: The patient was originally referred to the Oral and Maxillofacial Surgery team with an isolated mass on her forehead. Biopsies were performed, which showed this was likely a metastatic deposit from thyroid cancer. CT-PET scan showed this was an isolated lesion. The patient had a total thyroidectomy, and the forehead lesion was managed with radiotherapy. On interval scanning, the patient’s bony lesion had increased in size and had new lung nodules, which likely represented further metastasis. Conclusion: Isolated bony metastases to the frontal bone are rare. An important clinical principle to remember is that a bony metastasis from an unknown primary is more likely than primary bone cancer.

Keywords: cancer, thyroid, head and neck, surgery

Procedia PDF Downloads 191
6827 The Economic Burden of Mental Disorders: A Systematic Review

Authors: Maria Klitgaard Christensen, Carmen Lim, Sukanta Saha, Danielle Cannon, Finley Prentis, Oleguer Plana-Ripoll, Natalie Momen, Kim Moesgaard Iburg, John J. McGrath

Abstract:

Introduction: About a third of the world’s population will develop a mental disorder over their lifetime. Having a mental disorder is a huge burden in health loss and cost for the individual, but also for society because of treatment cost, production loss and caregivers’ cost. The objective of this study is to synthesize the international published literature on the economic burden of mental disorders. Methods: Systematic literature searches were conducted in the databases PubMed, Embase, Web of Science, EconLit, NHS York Database and PsychInfo using key terms for cost and mental disorders. Searches were restricted to 1980 until May 2019. The inclusion criteria were: (1) cost-of-illness studies or cost-analyses, (2) diagnosis of at least one mental disorder, (3) samples based on the general population, and (4) outcome in monetary units. 13,640 publications were screened by their title/abstract and 439 articles were full-text screened by at least two independent reviewers. 112 articles were included from the systematic searches and 31 articles from snowball searching, giving a total of 143 included articles. Results: Information about diagnosis, diagnostic criteria, sample size, age, sex, data sources, study perspective, study period, costing approach, cost categories, discount rate and production loss method and cost unit was extracted. The vast majority of the included studies were from Western countries and only a few from Africa and South America. The disorder group most often investigated was mood disorders, followed by schizophrenia and neurotic disorders. The disorder group least examined was intellectual disabilities, followed by eating disorders. The preliminary results show a substantial variety in the used perspective, methodology, costs components and outcomes in the included studies. An online tool is under development enabling the reader to explore the published information on costs by type of mental disorder, subgroups, country, methodology, and study quality. Discussion: This is the first systematic review synthesizing the economic cost of mental disorders worldwide. The paper will provide an important and comprehensive overview over the economic burden of mental disorders, and the output from this review will inform policymaking.

Keywords: cost-of-illness, health economics, mental disorders, systematic review

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6826 Advances in Medication Reconciliation Tools

Authors: Zixuan Liu, Xin Zhang, Kexin He

Abstract:

In the context of widespread prevalence of multiple diseases, medication safety has become a highly concerned issue affecting patient safety. Medication reconciliation plays a vital role in preventing potential medication risks. However, in medical practice, medication reconciliation faces various challenges, and there is a wide variety of medication reconciliation tools, making the selection of appropriate tools somewhat difficult. The article introduces and analyzes the currently available medication reconciliation tools, providing a reference for healthcare professionals to choose and apply the appropriate medication reconciliation tools.

Keywords: patient safety, medication reconciliation, tools, review

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6825 A Retrospective Study on the Spectrum of Infection and Emerging Antimicrobial Resistance in Type 2 Diabetes Mellitus

Authors: Pampita Chakraborty, Sukumar Mukherjee

Abstract:

People with diabetes mellitus are more susceptible to developing infections, as high blood sugar levels can weaken the patient's immune system defences. People with diabetes are more adversely affected when they get an infection than someone without the disease, because you have weakened immune defences in diabetes. People who have minimally elevated blood sugar levels experience worse outcomes with infections. Diabetic patients in hospitals do not necessarily have a higher mortality rate due to infections, but they do face longer hospitalisation and recovery times. A study was done in a tertiary care unit in eastern India. Patients with type 2 diabetes mellitus infection were recruited in the study. A total of 520 cases of Type 2 Diabetes Mellitus were recorded out of which 200 infectious cases was included in the study. All subjects underwent detailed history & clinical examination. Microbiological samples were collected from respective site of the infection for microbial culture and antibiotic sensitivity test. Out of the 200 infectious cases urinary tract infection(UTI) was found in majority of the cases followed by diabetic foot ulcer (DFU), respiratory tract infection(RTI) and sepsis. It was observed that Escherichia coli was the most commonest pathogen isolated from UTI cases and Staphylococcus aureus was predominant in foot ulcers followed by other organisms. Klebsiella pneumonia was the major organism isolated from RTI and Enterobacter aerogenes was commonly observed in patients with sepsis. Isolated bacteria showed differential sensitivity pattern against commonly used antibiotics. The majority of the isolates were resistant to several antibiotics that are usually prescribed on an empirical basis. These observations are important, especially for patient management and the development of antibiotic treatment guidelines. It is recommended that diabetic patients receive pneumococcal and influenza vaccine annually to reduce morbidity and mortality. Appropriate usage of antibiotics based on local antibiogram pattern can certainly help the clinician in reducing the burden of infections.

Keywords: antimicrobial resistance, diabetic foot ulcer, respiratory tract infection, urinary tract infection

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6824 Combined Orthodontic and Restorative Management of Complex Cases: Concepts and Case Reports

Authors: Awais Ali, Hesham Ali

Abstract:

The absence of teeth through either premature loss or developmental absence is a common condition with potentially severe impact on affected individuals. Management of these cases presents a clinical challenge which may be difficult to resolve given the effects of tooth loss or hypodontia over the course of a patient’s lifetime. Treatment of such cases is often best provided by a multi-disciplinary team, where the patient’s expectations and care delivery can be optimally managed. Orthodontic treatment is often used to prepare the dentition in advance of restorative replacement of missing teeth. Conversely, the placement of implants may precede the delivery of orthodontic treatment and indeed may function as an adjunctive orthodontic procedure. We discuss the use of both approaches here and illustrate their clinical implementation with two case reports. The first case demonstrates the use of fixed appliances to prepare the mouth for an opposing implant-retained complete denture. A second case demonstrates the use of implant-retained crowns to provide orthodontic anchorage in a partially dentate patient. We propose that complex cases such as these should always be planned and treated by a multi-disciplinary team in order to optimise the delivery of care, patient experience, and treatment outcome. The presented cases add to the body of evidence in this area.

Keywords: orthodontics, dental implantology, hypodontia, multi-disciplinary

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6823 School and Family Impairment Associated with Childhood Anxiety Disorders: Examining Differences in Parent and Child Report

Authors: Melissa K. Hord, Stephen P. Whiteside

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Impairment in functioning is a requirement for diagnosing psychopathology, identifying individuals in need of treatment, and documenting improvement with treatment. Further, identifying different types of functional impairment can guide educators and treatment providers. However, most assessment tools focus on symptom severity and few measures assess impairment associated with childhood anxiety disorders. The child- and parent-report versions of the Child Sheehan Disability Scale (CSDS) are measures that may provide useful information regarding impairment. The purpose of the present study is to examine whether children diagnosed with different anxiety disorders have greater impairment in school or home functioning based on self or parent report. The sample consisted of 844 children ages 5 to 19 years of age (mean 13.43, 61% female, 90.9% Caucasian), including 281 children diagnosed with obsessive compulsive disorder (OCD), 200 with generalized anxiety disorder (GAD), 176 with social phobia, 83 with separation anxiety, 61 with anxiety not otherwise specified (NOS), 30 with panic disorder, and 13 with panic with agoraphobia. To assess whether children and parents reported greater impairment in school or home functioning, a multivariate analysis of variance was conducted. (The assumptions of independence and homogeneity of variance were checked and met). A significant difference was found, Pillai's trace = .143, F (4, 28) = 4.19, p < .001, partial eta squared = .04. Post hoc comparisons using the Tukey HSD test indicated that children report significantly greater impairment in school with panic disorder (M=5.18, SD=3.28), social phobia (M=4.95, SD=3.20), and OCD (M=4.62, SD=3.32) compared to other diagnoses; whereas parents endorse significantly greater school impairment when their child has a social phobia (M=5.70, SD=3.39) diagnosis. Interestingly, both children and parents reported greater impairment in family functioning for an OCD (child report M=5.37, SD=3.20; parent report M=5.59, SD=3.38) diagnosis compared to other anxiety diagnoses. (Additional findings for the anxiety disorders associated with less impairment will also be presented). The results of the current study have important implications for educators and treatment providers who are working with anxious children. First, understanding that differences exist in how children and parents view impairment related to childhood anxiety can help those working with these families to be more sensitive during interactions. Second, evidence suggests that difficulties in one environment do not necessarily translate to another environment, thus caregivers may benefit from careful explanation of observations obtained by educators. Third, results support the use of the CSDS measure by treatment providers to identify impairment across environments in order to more effectively target interventions.

Keywords: anxiety, childhood, impairment, school functioning

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6822 Multilevel of Factors Affected Optimal Adherence to Antiretroviral Therapy and Viral Suppression amongst HIV-Infected Prisoners in South Ethiopia: A Prospective Cohort Study

Authors: Terefe Fuge, George Tsourtos , Emma Miller

Abstract:

Objectives: Maintaining optimal adherence and viral suppression in people living with HIV (PLWHA) is essential to ensure both preventative and therapeutic benefits of antiretroviral therapy (ART). Prisoners bear a particularly high burden of HIV infection and are highly likely to transmit to others during and after incarceration. However, the level of adherence and viral suppression, as well as its associated factors in incarcerated populations in low-income countries is unknown. This study aimed to determine the prevalence of non-adherence and viral failure, and contributing factors to this amongst prisoners in South Ethiopia. Methods: A prospective cohort study was conducted between June 1, 2019 and July 31, 2020 to compare the level of adherence and viral suppression between incarcerated and non-incarcerated PLWHA. The study involved 74 inmates living with HIV (ILWHA) and 296 non-incarcerated PLWHA. Background information including sociodemographic, socioeconomic, psychosocial, behavioural, and incarceration-related characteristics was collected using a structured questionnaire. Adherence was determined based on participants’ self-report and pharmacy refill records, and plasma viral load measurements which were undertaken within the study period were prospectively extracted to determine viral suppression. Various univariate and multivariate regression models were used to analyse data. Results: Self-reported dose adherence was approximately similar between ILWHA and non-incarcerated PLWHA (81% and 83% respectively), but ILWHA had a significantly higher medication possession ratio (MPR) (89% vs 75%). The prevalence of viral failure (VF) was slightly higher (6%) in ILWHA compared to non-incarcerated PLWHA (4.4%). The overall dose non-adherence (NA) was significantly associated with missing ART appointments, level of satisfaction with ART services, patient’s ability to comply with a specified medication schedule and types of methods used to monitor the schedule. In ILWHA specifically, accessing ART services from a hospital compared to a health centre, an inability to always attend clinic appointments, experience of depression and a lack of social support predicted NA. VF was significantly higher in males, people of age 31-35 years and in those who experienced social stigma, regardless of their incarceration status. Conclusions: This study revealed that HIV-infected prisoners in South Ethiopia were more likely to be non-adherent to doses and so to develop viral failure compared to their non-incarcerated counterparts. A multitude of factors was found to be responsible for this requiring multilevel intervention strategies focusing on the specific needs of prisoners.

Keywords: Adherence , Antiretroviral therapy, Incarceration, South Ethiopia, Viral suppression

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6821 Non Pharmacological Approach to IBS (Irritable Bowel Syndrome)

Authors: A. Aceranti, L. Moretti, S. Vernocchi, M. Colorato, P. Caristia

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Irritable bowel syndrome (IBS) is the association between abdominal pain, abdominal distension and intestinal dysfunction for recurring periods. About 10% of the world's population has IBS at any given time in their life, and about 200 people per 100,000 receive an initial diagnosis of IBS each year. Persistent pain is recognized as one of the most pervasive and challenging problems facing the medical community today. Persistent pain is considered more as a complex pathophysiological, diagnostic and therapeutic situation rather than as a persistent symptom. The low efficiency of conventional drug treatments has led many doctors to become interested in the non-drug alternative treatment of IBS, especially for more severe cases. Patients and providers are often dissatisfied with the available drug remedies and often seek complementary and alternative medicine (CAM), a unique and holistic approach to treatment that is not a typical component of conventional medicine. Osteopathic treatment may be of specific interest in patients with IBS. Osteopathy is a complementary health approach that emphasizes the role of the musculoskeletal system in health and promotes optimal function of the body's tissues using a variety of manual techniques to improve body function. Osteopathy has been defined as a patient-centered health discipline based on the principles of interrelation between body structure and function, the body's innate capacity for self-healing and the adoption of a whole person health approach. mainly by practicing manual processing. Studies reported that osteopathic manual treatment (OMT) reduced IBS symptoms, such as abdominal pain, constipation, diarrhea, and improved general well-being. The focus in the treatment of IBS with osteopathy has gone beyond simple spinal alignment, to directly address the abnormal physiology of the body using a series of direct and indirect techniques. The topic of this study was chosen for different reasons: due to the large number of people involved who suffer from this disorder and for the dysfunction itself, since nowadays there is still little clarity about the best type of treatment and, above all, to its origin. The visceral component in the osteopathic field is still a world to be discovered, although it is related to a large part of patient series, it has contents that affect numerous disciplines and this makes it an enigma yet to be solved. The study originated in the didactic practice where the curiosity of a topic is marked that, even today, no one is able to explain and, above all, cure definitively. The main purpose of this study is to try to create a good basis on the osteopathic discipline for subsequent studies that can be exhaustive in the best possible way, resolving some doubts about which treatment modality can be used with more relevance. The path was decided to structure it in such a way that 3 types of osteopathic treatment are used on 3 groups of people who will be selected after completing a questionnaire, which will deem them suitable for the study. They will, in fact, be divided into three groups where: - the first group was given a visceral osteopathic treatment. - The second group was given a manual osteopathic treatment of neurological stimulation. - The third group received a placebo treatment. At the end of the treatment, questionnaires will be re-proposed respectively one week after the session and one month after the treatment from which any data will be collected that will demonstrate the effectiveness or otherwise of the treatment received. The sample of 50 patients examined underwent an oral interview to evaluate the inclusion and exclusion criteria to participate in the study. Of the 50 patients questioned, 17 people who underwent different osteopathic techniques were eligible for the study. Comparing the data related to the first assessment of tenderness and frequency of symptoms with the data related to the first follow-up shows a significant improvement in the score assigned to the different questions, especially in the neurogenic and visceral groups. We are aware of the fact that it is a study performed on a small sample of patients, and this is a penalizing factor. We remain, however, convinced that having obtained good results in terms of subjective improvement in the quality of life of the subjects, it would be very interesting to re-propose the study on a larger sample and fill the gaps.

Keywords: IBS, osteopathy, colon, intestinal inflammation

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6820 Value Gaps Between Patients and Doctors

Authors: Yih-Jer Wu, Ling-Lang Huang

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Shared decision-making (SDM) is a critical aspect of determining optimal medical strategies. However, current patient decision aids (PDAs) often prioritize evidence-based discussions over value-based considerations. Despite its significance, there is limited research addressing the 'value gap' between patients and healthcare providers. To address this gap, we developed the 'Patient-Doctor Relationship Questionnaire,' consisting of 12 questions. To explore potential variations in the patient-doctor value gap across different medical specialties, we conducted interviews with physicians, surgeons, and their respective patients, utilizing the questionnaire. Between 2020 and 2022, we interviewed a total of 144 patients and 19 doctors. Among the 12 questions, physicians demonstrated significant patient-doctor value gaps in 5 questions, while surgeons in 3 questions. Only one question turned out significant gaps in both physicians and surgeons. When asking both doctors and their patients to choose one from the following 6 answers (1. No issue significant; 2. Not knowing how to make a medical decision; 3. Not confident in the doctor’s clinical judgment; 4. Not knowing how to articulate one’s own condition; 5. Unable to afford medical expenses; 6. Not understanding what doctors explain) in response to the question “what the most significant issue is in the medical consultation”, over 50% of doctors chose “Not knowing how to make a medical decision” (physicians vs. patients, 50% vs. 11%, p=0.046; surgeon vs. patients, 83% vs. 29%, p=0.001), while significantly more patients chose “No issue significant” (10% vs. 52%, p=0.002; 0% vs. 33%, p<0.001, respectively). Our findings indicate that value gaps do exist between patients and doctors and that most patients in Taiwan "fully trust" their doctors' recommendations for medical decisions. However, when treatment outcomes are far from ideal, this overinflated "trust" may turn into frustration, which could become the catalyst for medical disputes. Doctors should spend more time having more effective communication with their patients, particularly regarding potentially dissatisfactory treatment outcomes. This study underscores the substantial variability in the patient-doctor value gap, often overlooked in SDM. Patients from different clinical backgrounds may hold values distinct from those of their healthcare providers. Bridging this value gap is imperative for achieving genuine and effective SDM.

Keywords: share-decision making, value gaps, communication, doctor-patient relationship

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6819 Outcome Analysis of Surgical and Nonsurgical Treatment on Indicated Operative Chronic Subdural Hematoma: Serial Case in Cipto Mangunkusumo Hospital Indonesia

Authors: Novie Nuraini, Sari Hanifa, Yetty Ramli

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Chronic subdural hematoma (cSDH) is a common condition after head trauma. Although the size of the thickness of cSDH has an important role in the decision to perform surgery, but the size limit of the thickness is not absolute. In this serial case report, we evaluate three case report of cSDH that indicated to get the surgical procedure because of deficit neurologic and neuroimaging finding with subfalcine herniation more than 0.5 cm and hematoma thickness more than one cm. On the first case, the patient got evacuation hematoma procedure, but the second and third case, we did nonsurgical treatment because the patient and family refused to do the operation. We did the conservative treatment with bed rest and mannitol. Serial radiologic evaluation is done when we found worsening condition. We also reevaluated radiologic examination two weeks after the treatment. The results in this serial case report, the first and second case have a good outcome. On the third case, there was a worsening condition, which in this patient there was a comorbid with type two diabetic mellitus, pneumonie and chronic kidney disease. Some conservative treatment such as bed rest, corticosteroid, mannitol or the other hyperosmolar has a good outcome in patient without neurologic deficits, small hematoma, and or patient without comorbid disease. Evacuate hematome is the best choice in cSDH treatment with deficit neurologic finding. Afterall, there is some condition that we can not do the surgical procedure. Serial radiologic examination needed after two weeks to evaluate the treatment or if there is any worsening condition.

Keywords: chronic subdural hematoma, traumatic brain injury, surgical treatment, nonsurgical treatment, outcome

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6818 The Correlation between the Anxiety of the Family Members of the Patients Referring to the Emergency Department and Their Views on the Communication Skills of Nurses

Authors: Mahnaz Seyedoshohadaee

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Background and Aims: Hospitalization of one of the family members in the hospital, especially in the emergency department, causes anxiety and psychological problems in family members and others. The way nurses interact with patients and their companions can play an important role in controlling and managing their anxiety. This study aims to determine the relationship between the anxiety of family members of patients referring to emergency departments and their views on the communication skills of nurses. Materials and Methods: The current research was a descriptive-correlation cross-sectional study on 263 family members of patients referred to the department. The emergency of two selected medical training centers affiliated with Iran University of Medical Sciences was performed. The samples were selected continuously in 2018 based on the inclusion criteria. Information was collected using the Health Communication Questionnaire (HCCQ) and Beck Anxiety Questionnaire (BAI). To analyze the data, Pearson's correlation coefficient, independent t-tests, analysis of variance, and Kruskal-Wallis were used at a significance level of 0.05. The data was analyzed using SPSS version 16 statistical software. Results: The mean score of communication skills of emergency department nurses from the point of view of patients' companions was at a low level (74.36 with a standard deviation of 3.7). 3.75% of patients' companions had anxiety at a mild level. There was no statistically significant correlation between the anxieties of the patient's companions. The anxiety of the patient's companions had a statistically significant relationship with the educational level (P=0.039), economic status (P=0.033), and family relationship with the patient (P=0.001). Also, the average anxiety score in children was significantly higher than that of patients' wives (P=0.008). The triage level of the patient also had a statistically significant relationship with the anxiety of the patient's companions (P>0.001). Conclusion: Most of the family members of the patients referred to the emergency room experienced mild anxiety. Also, from their point of view, the communication skills of emergency nurses were at a weak level. Despite the fact that there was no statistically significant relationship between the patient's family member's anxiety and their opinion about nurses' communication skills in this study, it seems that the weak communication skills of nurses from the patient's family member's point of view need special attention. The results of the present study can provide the necessary grounds for planning to improve the communication skills of nurses and also control the anxiety of patient caregivers through in-service training or other incentive mechanisms.

Keywords: anxiety, family, emergency department, communication skills, nurse

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6817 Predictors of Lost to Follow-Up among HIV Patients Attending Anti-Retroviral Therapy Treatment Centers in Nigeria

Authors: Oluwasina Folajinmi, Kate Ssamulla, Penninah Lutung, Daniel Reijer

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Background: Despite of well-verified benefits of anti-retroviral therapy (ART) in prolonging life expectancy being lost to follow-up (LTFU) presents a challenge to the success of ART programs in resource limited countries like Nigeria. In several studies of ART programs in developing countries, researchers have reported that there has been a high rate of LTFU among patients receiving care and treatment at ART treatment centers. This study seeks to determine the cause of LTFU among HIV clients. Method: A descriptive cross sectional study focused on a population of 9,280 persons living with HIV/AIDS who were enrolled in nine treatment centers in Nigeria (both pre-ART and ART patients were included). Out of the total population, 1752 (18.9%) were found to be LTFU. Of this group we randomly selected 1200 clients (68.5%) their d patients’ information was generated through a database. Data on demographics and CD4 counts, causes of LTFU were analyzed and summarized. Results: Out of 1200 LTFU clients selected, 462 (38.5%) were on ART; 341 clients (73.8%) had CD4 level < 500cell/µL and 738 (61.5%) on pre-ART had CD4 level >500/µL. In our records we found telephone number for 675 (56.1%) of these clients. 675 (56.1%) were owners of a phone. The majority of the client’s 731 (60.9%) were living at not more than 25km away from the ART center. A majority were females (926 or 77.2%) while 274 (22.8%) were male. 675 (56.1%) clients were reported traced via telephone and home address. 326 (27.2%) of clients phone numbers were not reachable; 173 (14.4%) of telephone numbers were incomplete. 71 (5.9%) had relocated due to communal crises and expert client trackers reported that some patient could not afford transportation to ART centers. Conclusion: This study shows that, low health education levels, poverty, relocations and lack of reliable phone contact were major predictors of LTFU. Periodic updates of home addresses, telephone contacts including at least two next of kin, phone text messages and home visits may improve follow up. Early and consistent tracking of missed appointments is crucial. Creation of more ART decentralized centres are needed to avoid long distances.

Keywords: anti-retroviral therapy, HIV/AIDS, predictors, lost to follow up

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6816 A Review of Brain Implant Device: Current Developments and Applications

Authors: Ardiansyah I. Ryan, Ashsholih K. R., Fathurrohman G. R., Kurniadi M. R., Huda P. A

Abstract:

The burden of brain-related disease is very high. There are a lot of brain-related diseases with limited treatment result and thus raise the burden more. The Parkinson Disease (PD), Mental Health Problem, or Paralysis of extremities treatments had risen concern, as the patients for those diseases usually had a low quality of life and low chance to recover fully. There are also many other brain or related neural diseases with the similar condition, mainly the treatments for those conditions are still limited as our understanding of the brain function is insufficient. Brain Implant Technology had given hope to help in treating this condition. In this paper, we examine the current update of the brain implant technology. Neurotechnology is growing very rapidly worldwide. The United States Food and Drug Administration (FDA) has approved the use of Deep Brain Stimulation (DBS) as a brain implant in humans. As for neural implant both the cochlear implant and retinal implant are approved by FDA too. All of them had shown a promising result. DBS worked by stimulating a specific region in the brain with electricity. This device is planted surgically into a very specific region of the brain. This device consists of 3 main parts: Lead (thin wire inserted into the brain), neurostimulator (pacemaker-like device, planted surgically in the chest) and an external controller (to turn on/off the device by patient/programmer). FDA had approved DBS for the treatment of PD, Pain Management, Epilepsy and Obsessive Compulsive Disorder (OCD). The target treatment of DBS in PD is to reduce the tremor and dystonia symptoms. DBS has been showing the promising result in animal and limited human trial for other conditions such as Alzheimer, Mental Health Problem (Major Depression, Tourette Syndrome), etc. Every surgery has risks of complications, although in DBS the chance is very low. DBS itself had a very satisfying result as long as the subject criteria to be implanted this device based on indication and strictly selection. Other than DBS, there are several brain implant devices that still under development. It was included (not limited to) implant to treat paralysis (In Spinal Cord Injury/Amyotrophic Lateral Sclerosis), enhance brain memory, reduce obesity, treat mental health problem and treat epilepsy. The potential of neurotechnology is unlimited. When brain function and brain implant were fully developed, it may be one of the major breakthroughs in human history like when human find ‘fire’ for the first time. Support from every sector for further research is very needed to develop and unveil the true potential of this technology.

Keywords: brain implant, deep brain stimulation (DBS), deep brain stimulation, Parkinson

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6815 Predictors of Clinical Failure After Endoscopic Lumbar Spine Surgery During the Initial Learning Curve

Authors: Daniel Scherman, Daniel Madani, Shanu Gambhir, Marcus Ling Zhixing, Yingda Li

Abstract:

Objective: This study aims to identify clinical factors that may predict failed endoscopic lumbar spine surgery to guide surgeons with patient selection during the initial learning curve. Methods: This is an Australasian prospective analysis of the first 105 patients to undergo lumbar endoscopic spine decompression by 3 surgeons. Modified MacNab outcomes, Oswestry Disability Index (ODI) and Visual Analogue Score (VAS) scores were utilized to evaluate clinical outcomes at 6 months postoperatively. Descriptive statistics and Anova t-tests were performed to measure statistically significant (p<0.05) associations between variables using GraphPad Prism v10. Results: Patients undergoing endoscopic lumbar surgery via an interlaminar or transforaminal approach have overall good/excellent modified MacNab outcomes and a significant reduction in post-operative VAS and ODI scores. Regardless of the anatomical location of disc herniations, good/excellent modified MacNab outcomes and significant reductions in VAS and ODI were reported post-operatively; however, not in patients with calcified disc herniations. Patients with central and foraminal stenosis overall reported poor/fair modified MacNab outcomes. However, there were significant reductions in VAS and ODI scores post-operatively. Patients with subarticular stenosis or an associated spondylolisthesis reported good/excellent modified MacNab outcomes and significant reductions in VAS and ODI scores post-operatively. Patients with disc herniation and concurrent degenerative stenosis had generally poor/fair modified MacNab outcomes. Conclusion: The outcomes of endoscopic spine surgery are encouraging, with a low complication and reoperation rate. However, patients with calcified disc herniations, central canal stenosis or a disc herniation with concurrent degenerative stenosis present challenges during the initial learning curve and may benefit from traditional open or other minimally invasive techniques.

Keywords: complications, lumbar disc herniation, lumbar endoscopic spine surgery, predictors of failed endoscopic spine surgery

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6814 Designing a Waitlist Intervention for Adult Patients Awaiting Outpatient Treatment for Eating Disorders: Preliminary Findings from a Pilot Test

Authors: Deanne McArthur, Melinda Wall, Claire Hanlon, Dana Agnolin, Krista Davis, Melanie Dennis, Elizabeth Glidden, Anne Marie Smith, Claudette Thomson

Abstract:

In Canada, as prevalence rates and severity of illness have increased among patients suffering from eating disorders, wait times have grown substantially. Patients in Canada often face wait times in excess of 12 months. It is known that delaying treatment for eating disorders contributes to poor patient outcomes and higher rates of symptom relapse. Improving interim services for adult patients awaiting outpatient treatment is a priority for an outpatient eating disorders clinic in Ontario, Canada. The clinical setting currently provides care for adults diagnosed with anorexia nervosa, bulimia nervosa and binge eating disorder. At present, the only support provided while patients are on the waitlist consists of communication with primary care providers regarding parameters for medical monitoring. The significance of this study will be to test the feasibility, acceptability and efficacy of an intervention to support adult patients awaiting outpatient eating disorder treatment for anorexia nervosa, bulimia nervosa and binge eating disorder. Methods: An intervention including psychoeducation, supportive resources, self-monitoring, and auxiliary referral will be pilot-tested with a group of patients in the summer of 2022 and detailed using a prospective cohort case study research design. The team will host patient focus groups in May 2022 to gather input informing the content of the intervention. The intervention will be pilot tested with newly-referred patients in June and July 2022. Patients who participate in the intervention will be asked to complete a survey evaluating the utility of the intervention and for suggestions, they may have for improvement. Preliminary findings describing the existing literature pertaining to waitlist interventions for patients with eating disorders, data gathered from the focus groups and early pilot testing results will be presented. Data analysis will continue throughout 2022 and early 2023 for follow-up publication and presentation in the summer of 2023. The aim of this study is to contribute to the body of knowledge pertaining to providing interim support to those patients waiting for treatment for eating disorders and, by extension, to improve outcomes for this population.

Keywords: eating disorders, waitlist management, intervention study, pilot test

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6813 The Antecedents of Internet Addiction toward Smartphone Usage

Authors: Pui-Lai To, Chechen Liao, Hen-Yi Huang

Abstract:

Twenty years after Internet development, scholars have started to identify the negative impacts brought by the Internet. Overuse of Internet could develop Internet dependency and in turn cause addiction behavior. Therefore understanding the phenomenon of Internet addiction is important. With the joint efforts of experts and scholars, Internet addiction has been officially listed as a symptom that affects public health, and the diagnosis, causes and treatment of the symptom have also been explored. On the other hand, in the area of smartphone Internet usage, most studies are still focusing on the motivation factors of smartphone usage. Not much research has been done on smartphone Internet addiction. In view of the increasing adoption of smartphones, this paper is intended to find out whether smartphone Internet addiction exists in modern society or not. This study adopted the research methodology of online survey targeting users with smartphone Internet experience. A total of 434 effective samples were recovered. In terms of data analysis, Partial Least Square (PLS) in Structural Equation Modeling (SEM) is used for sample analysis and research model testing. Software chosen for statistical analysis is SPSS 20.0 for windows and SmartPLS 2.0. The research result successfully proved that smartphone users who access Internet service via smartphone could also develop smartphone Internet addiction. Factors including flow experience, depression, virtual social support, smartphone Internet affinity and maladaptive cognition all have significant and positive influence on smartphone Internet addiction. In the scenario of smartphone Internet use, descriptive norm has a positive and significant influence on perceived playfulness, while perceived playfulness also has a significant and positive influence on flow experience. Depression, on the other hand, is negatively influenced by actual social support and positive influenced by the virtual social support.

Keywords: internet addiction, smartphone usage, social support, perceived playfulness

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6812 Culturally Adapting Videos to Involve Nigerian Patients with Cancer in Clinical Trials

Authors: Abiola Falilat Ibraheem, Akinyimika Sowunmi, Valerie Otti

Abstract:

Background: Introduction of innovative cancer clinical trials to Nigeria is a critical step in addressing global inequities of cancer burden. Low health and clinical trial literacy among Nigerian patients have been sighted as a significant barrier to ensuring that patients enrolled in clinical trials are truly informed. Video intervention has been shown to be the most proactive method to improving patient’s clinical trial knowledge. In the US, video interventions have been successful at improving education about cancer clinical trials among minority patients. Thus, this study aimed to apply and adapt video interventions addressing attitudinal barriers peculiar to Nigerian patients. Methods: A hospital-based representative mixed-method study was conducted at the Lagos State University Teaching Hospital (LASUTH) from July to December 2020, comprising of cancer patients aged 18 and above. Patients were randomly selected during every clinic day, of which 63 patients volunteered to participate in this study. We first administered a cancer literacy survey to determine patients’ knowledge about clinical trials. For patients who had prior knowledge, a pre-intervention test was administered, after which a 15-minute video (attitudes and intention to enroll in therapeutic clinical trials (AIET)) to improve patients’ knowledge, perception, and attitudes towards clinical trials was played, and then ended by administering a post-intervention test to the patients. For patients who had no prior knowledge, the AIET video was played for them, followed by the post-intervention test. Results: Out of 63 patients sampled, 43 (68.3%) had breast cancer. On average, patients agreed to understand their cancer diagnosis and treatment very well. 84.1% of patients had never heard about cancer clinical trials, and 85.7% did not know what cancer clinical trials were. There was a strong positive relationship (r=0.916) between the pretest and posttest, which means that the intervention improved patients’ knowledge, perception, and attitudes about cancer clinical trials. In the focus groups, patients recommended adapting the video in Nigerian settings and representing all religions in order to address trust in local clinical trialists. Conclusion: Due to the small size of patients, change in clinical trial knowledge was not statistically significant. However, there is a trend suggesting that culturally adapted video interventions can be used to improve knowledge and perception about cancer clinical trials.

Keywords: clinical trials, culturally targeted intervention, patient education, video intervention

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6811 Stroke Rehabilitation via Electroencephalogram Sensors and an Articulated Robot

Authors: Winncy Du, Jeremy Nguyen, Harpinder Dhillon, Reinardus Justin Halim, Clayton Haske, Trent Hughes, Marissa Ortiz, Rozy Saini

Abstract:

Stroke often causes death or cerebro-vascular (CV) brain damage. Most patients with CV brain damage lost their motor control on their limbs. This paper focuses on developing a reliable, safe, and non-invasive EEG-based robot-assistant stroke rehabilitation system to help stroke survivors to rapidly restore their motor control functions for their limbs. An electroencephalogram (EEG) recording device (EPOC Headset) and was used to detect a patient’s brain activities. The EEG signals were then processed, classified, and interpreted to the motion intentions, and then converted to a series of robot motion commands. A six-axis articulated robot (AdeptSix 300) was employed to provide the intended motions based on these commends. To ensure the EEG device, the computer, and the robot can communicate to each other, an Arduino microcontroller is used to physically execute the programming codes to a series output pins’ status (HIGH or LOW). Then these “hardware” commends were sent to a 24 V relay to trigger the robot’s motion. A lookup table for various motion intensions and the associated EEG signal patterns were created (through training) and installed in the microcontroller. Thus, the motion intention can be direct determined by comparing the EEG patterns obtaibed from the patient with the look-up table’s EEG patterns; and the corresponding motion commends are sent to the robot to provide the intended motion without going through feature extraction and interpretation each time (a time-consuming process). For safety sake, an extender was designed and attached to the robot’s end effector to ensure the patient is beyond the robot’s workspace. The gripper is also designed to hold the patient’s limb. The test results of this rehabilitation system show that it can accurately interpret the patient’s motion intension and move the patient’s arm to the intended position.

Keywords: brain waves, EEG sensor, motion control, robot-assistant stroke rehabilitation

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6810 Onco@Home: Comparing the Costs, Revenues, and Patient Experience of Cancer Treatment at Home with the Standard of Care

Authors: Sarah Misplon, Wim Marneffe, Johan Helling, Jana Missiaen, Inge Decock, Dries Myny, Steve Lervant, Koen Vaneygen

Abstract:

The aim of this study was twofold. First, we investigated whether the current funding from the national health insurance (NHI) of home hospitalization (HH) for oncological patients is sufficient in Belgium. Second, we compared patient’s experiences and preferences of HH to the standard of care (SOC). Two HH models were examined in three Belgian hospitals and three home nursing organizations. In a first HH model, the blood draw and monitoring prior to intravenous therapy were performed by a trained home nurse at the patient’s home the day before the visit to the day hospital. In a second HH model, the administration of two subcutaneous treatments was partly provided at home instead of in the hospital. Therefore, we conducted (1) a bottom-up micro-costing study to compare the costs and revenues for the providers (hospitals and home care organizations), and (2) a cross-sectional survey to compare patient’s experiences and preferences of the SOC group and the HH group. Our results show that HH patients prefer HH and none of them wanted to return to SOC, although the satisfaction of patients was not significantly different between the two categories. At the same time, we find that costs associated to HH are higher overall. Comparing revenues with costs, we conclude that the current funding from NHI of HH for oncological patients is insufficient.

Keywords: cost analysis, health insurance, preference, home hospitalization

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6809 Burden of Dengue in Northern India

Authors: Ashutosh Biswas, Poonam Coushic, Kalpana Baruah, Paras Singla, A. C. Dhariwal, Pawana Murthy

Abstract:

Burden of Dengue in Northern India Ashutosh Biswas, Poonam Coushic, Kalpana Baruah, Paras Singla, AC Dhariwal, Pawana Murthy. All India Institute of Medical Sciences, NVBDCP,WHO New Delhi, India Aim: This study was conducted to estimate the burden of dengue in capital region of India. Methodology:Seropositivity of Dengue for IgM Ab, NS1 Ag and IgG Ab were performed among the blood donors’ samples from blood bank, those who were coming to donate blood for the requirement of blood for the admitted patients in hospital. Blood samplles were collected through out the year to estimate seroprevalance of dengue with or without outbreak season. All the subjects were asymptomatic at the time of blood donation. Results: A total of 1558 donors were screened for the study. On the basis of inclusion/ exclusion criteria, we enrolled 1531subjects for the study.Twenty seven donors were excluded from the study, out of which 6 were detected HIV +ve, 11 were positive for HBsAg and 10 were found positive for HCV.Mean age was 30.51 ± 7.75 years.Of 1531subjects, 18 (1.18%) had a past history of typhoid fever, 28 (1.83%) had chikungunya fever, 9 (0.59%) had malaria and 43 subjects (2.81%) had a past history of symptomatic dengue infection.About 2.22% (34) of subjects were found to have sero-positive for NS1 Ag with a peak point prevalence of 7.14% in the month of October and sero-positive of IgM Ab was observed about 5.49% (84)with a peak point prevalence of 14.29% in the month of October. Sero-prevalnce of IgGwas detected in about 64.21% (983) of subjects. Conclusion: Acute asymptomatic dengue (NS1 Ag+ve) was observed in 7.14%, as the subjects were having no symptoms at the time of sampling. This group of subjects poses a potential public health threat for transmitting dengue infection through blood transfusion (TTI) in the community as evident by presence of active viral infection due to NS1Ag +VE. Therefore a policy may be implemented in the blood bank for testing NS1 Ag to look for active dengue infection for preventing dengue transmission through blood transfusion (TTI). Acute or Subacute dengue infection ( IgM Ab+ve) was observed from 5.49% to 14.29% which is a peak point prevalence in the month of October. About 64.21% of the population were immunized by natural dengue infection ( IgG Ab+ve) in theNorthern province of India. This might be helpful for implementing the dengue vaccine in a region. Blood samples in blood banks should be tested for dengue before transfusion to any other person to prevent transfusion transmitted dengue infection as we estimated upto 7.14% positivity of NS1 Ag in our study which indicates presence of dengue virus in blood donors’ samples.

Keywords: Dengue Burden, Seroprevalance, Asymptomatic dengue, Dengue transmission through blood transfusion

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6808 A Pilot Study on Integration of Simulation in the Nursing Educational Program: Hybrid Simulation

Authors: Vesile Unver, Tulay Basak, Hatice Ayhan, Ilknur Cinar, Emine Iyigun, Nuran Tosun

Abstract:

The aim of this study is to analyze the effects of the hybrid simulation. In this simulation, types standardized patients and task trainers are employed simultaneously. For instance, in order to teach the IV activities standardized patients and IV arm models are used. The study was designed as a quasi-experimental research. Before the implementation an ethical permission was taken from the local ethical commission and administrative permission was granted from the nursing school. The universe of the study included second-grade nursing students (n=77). The participants were selected through simple random sample technique and total of 39 nursing students were included. The views of the participants were collected through a feedback form with 12 items. The form was developed by the authors and “Patient intervention self-confidence/competence scale”. Participants reported advantages of the hybrid simulation practice. Such advantages include the following: developing connections between the simulated scenario and real life situations in clinical conditions; recognition of the need for learning more about clinical practice. They all stated that the implementation was very useful for them. They also added three major gains; improvement of critical thinking skills (94.7%) and the skill of making decisions (97.3%); and feeling as if a nurse (92.1%). In regard to the mean scores of the participants in the patient intervention self-confidence/competence scale, it was found that the total mean score for the scale was 75.23±7.76. The findings obtained in the study suggest that the hybrid simulation has positive effects on the integration of theoretical and practical activities before clinical activities for the nursing students.

Keywords: hybrid simulation, clinical practice, nursing education, nursing students

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6807 The Clinical Significance of Cutaneous Leishmaniasis in Immigrant and Refugee Populations

Authors: Promise Ufomadu, Edgar Rodriguez, Grace Lee

Abstract:

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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6806 Optimal Temperature and Duration for Dabbing Customers with the Massage Compressed Packs Reported from Customers' Perception

Authors: Wichan Lertlop, Boonyarat Chaleephay

Abstract:

The objective of this research was to study the appropriate thermal level and time for dabbing customers with the massage compressed pack reported from their perception. The investigation was conducted by comparing different angles of tilted heads done by the customers together with their perception before and after the dabbing. The variables included different temperature of the compressed packs and different dabbing duration. Samples in this study included volunteers who got massage therapy and dabbing with hot compressed packs by traditional Thai medical students. The experiment was conducted during January to June 2013. The research tool consisted of angle meters, stop watches, thermometers, and massage compressed packs. The customers were interviewed for their perceptions before and after the dabbing. The results showed that: 1. There was a difference of the average angles of tilted heads before and after the dabbing. 2. There was no difference of the average angles at different temperatures but constant duration. 3. There was no difference of the average angles at different durations. 4. The customers reported relaxation no matter what the various temperatures and various dabbing durations were. However, they reported too hot at the temperature 70 °C and over.

Keywords: massage, therapy, therapeutic systems, technologies

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6805 MANIFEST-2, a Global, Phase 3, Randomized, Double-Blind, Active-Control Study of Pelabresib (CPI-0610) and Ruxolitinib vs. Placebo and Ruxolitinib in JAK Inhibitor-Naïve Myelofibrosis Patients

Authors: Claire Harrison, Raajit K. Rampal, Vikas Gupta, Srdan Verstovsek, Moshe Talpaz, Jean-Jacques Kiladjian, Ruben Mesa, Andrew Kuykendall, Alessandro Vannucchi, Francesca Palandri, Sebastian Grosicki, Timothy Devos, Eric Jourdan, Marielle J. Wondergem, Haifa Kathrin Al-Ali, Veronika Buxhofer-Ausch, Alberto Alvarez-Larrán, Sanjay Akhani, Rafael Muñoz-Carerras, Yury Sheykin, Gozde Colak, Morgan Harris, John Mascarenhas

Abstract:

Myelofibrosis (MF) is characterized by bone marrow fibrosis, anemia, splenomegaly and constitutional symptoms. Progressive bone marrow fibrosis results from aberrant megakaryopoeisis and expression of proinflammatory cytokines, both of which are heavily influenced by bromodomain and extraterminal domain (BET)-mediated gene regulation and lead to myeloproliferation and cytopenias. Pelabresib (CPI-0610) is an oral small-molecule investigational inhibitor of BET protein bromodomains currently being developed for the treatment of patients with MF. It is designed to downregulate BET target genes and modify nuclear factor kappa B (NF-κB) signaling. MANIFEST-2 was initiated based on data from Arm 3 of the ongoing Phase 2 MANIFEST study (NCT02158858), which is evaluating the combination of pelabresib and ruxolitinib in Janus kinase inhibitor (JAKi) treatment-naïve patients with MF. Primary endpoint analyses showed splenic and symptom responses in 68% and 56% of 84 enrolled patients, respectively. MANIFEST-2 (NCT04603495) is a global, Phase 3, randomized, double-blind, active-control study of pelabresib and ruxolitinib versus placebo and ruxolitinib in JAKi treatment-naïve patients with primary MF, post-polycythemia vera MF or post-essential thrombocythemia MF. The aim of this study is to evaluate the efficacy and safety of pelabresib in combination with ruxolitinib. Here we report updates from a recent protocol amendment. The MANIFEST-2 study schema is shown in Figure 1. Key eligibility criteria include a Dynamic International Prognostic Scoring System (DIPSS) score of Intermediate-1 or higher, platelet count ≥100 × 10^9/L, spleen volume ≥450 cc by computerized tomography or magnetic resonance imaging, ≥2 symptoms with an average score ≥3 or a Total Symptom Score (TSS) of ≥10 using the Myelofibrosis Symptom Assessment Form v4.0, peripheral blast count <5% and Eastern Cooperative Oncology Group performance status ≤2. Patient randomization will be stratified by DIPSS risk category (Intermediate-1 vs Intermediate-2 vs High), platelet count (>200 × 10^9/L vs 100–200 × 10^9/L) and spleen volume (≥1800 cm^3 vs <1800 cm^3). Double-blind treatment (pelabresib or matching placebo) will be administered once daily for 14 consecutive days, followed by a 7 day break, which is considered one cycle of treatment. Ruxolitinib will be administered twice daily for all 21 days of the cycle. The primary endpoint is SVR35 response (≥35% reduction in spleen volume from baseline) at Week 24, and the key secondary endpoint is TSS50 response (≥50% reduction in TSS from baseline) at Week 24. Other secondary endpoints include safety, pharmacokinetics, changes in bone marrow fibrosis, duration of SVR35 response, duration of TSS50 response, progression-free survival, overall survival, conversion from transfusion dependence to independence and rate of red blood cell transfusion for the first 24 weeks. Study recruitment is ongoing; 400 patients (200 per arm) from North America, Europe, Asia and Australia will be enrolled. The study opened for enrollment in November 2020. MANIFEST-2 was initiated based on data from the ongoing Phase 2 MANIFEST study with the aim of assessing the efficacy and safety of pelabresib and ruxolitinib in JAKi treatment-naïve patients with MF. MANIFEST-2 is currently open for enrollment.

Keywords: CPI-0610, JAKi treatment-naïve, MANIFEST-2, myelofibrosis, pelabresib

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6804 Rare Case of Pyoderma Gangrenosum of the Upper Limb

Authors: Karissa A. Graham

Abstract:

Pyoderma gangrenosum (PG) is a prototypic autoinflammatory neutrophilic dermatosis that is a rare disorder. It presents a diagnostic challenge owing to its variable presentation, clinical overlap with other conditions, it is often associated with other systemic conditions, and there is no definitive histological or laboratory characteristic. The Delphai consensus for PG includes the presence of at least one ulcer on the anterior lower limb. Systemic corticosteroids and immunosuppressive therapies are the mainstay treatment for PG. We describe a case report of delayed diagnosis of ulcerative pyoderma gangrenosum in a 44-year-old male on his forearm. The patient presented with an infected ulcer on his right forearm that had been present for over three years. The patient was a Type 2 Diabetic with no personal or family history of inflammatory bowel disease or other autoimmune diseases. The patient was initially investigated for malignancy, but biopsies returned as chronic inflammatory tissue with neutrophilic infiltrate and no malignancy. The patient was commenced on systemic prednisone for the treatment of pyoderma gangrenosum. The diagnosis of ulcerative PG poses a challenge given the vast differential diagnosis for a cutaneous ulcer (i.e., malignant, vascular, autoimmune, trauma, infective, etc.). Diagnostic accuracy is important given that the treatment for PG with steroids does not go without risks and indeed may be contraindicated in other potential causes of the ulcer. Indeed, more common and more sinister causes of ulcers should be investigated first, as death from PG is quite rare.

Keywords: dermatological diagnosis, dermatosis, pyoderma gangrenosum, rare presentation

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6803 Pediatric Drug Resistance Tuberculosis Pattern, Side Effect Profile and Treatment Outcome: North India Experience

Authors: Sarika Gupta, Harshika Khanna, Ajay K Verma, Surya Kant

Abstract:

Background: Drug-resistant tuberculosis (DR-TB) is a growing health challenge to global TB control efforts. Pediatric DR-TB is one of the neglected infectious diseases. In our previously published report, we have notified an increased prevalence of DR-TB in the pediatric population at a tertiary health care centre in North India which was estimated as 17.4%, 15.1%, 18.4%, and 20.3% in (%) in the year 2018, 2019, 2020, and 2021. Limited evidence exists about a pattern of drug resistance, side effect profile and programmatic outcomes of Paediatric DR-TB treatment. Therefore, this study was done to find out the pattern of resistance, side effect profile and treatment outcome. Methodology: This was a prospective cohort study conducted at the nodal drug-resistant tuberculosis centre of a tertiary care hospital in North India from January 2021 to December 2022. Subjects included children aged between 0-18 years of age with a diagnosis of DR-TB, on the basis of GeneXpert (rifampicin [RIF] resistance detected), line probe assay and drug sensitivity testing (DST) of M. tuberculosis (MTB) grown on a culture of body fluids. Children were classified as monoresistant TB, polyresistant TB (resistance to more than 1 first-line anti-TB drug, other than both INH and RIF), MDR-TB, pre-XDR-TB and XDR-TB, as per the WHO classification. All the patients were prescribed DR TB treatment as per the standard guidelines, either shorter oral DR-TB regimen or a longer all-oral MDR/XDR-TB regimen (age below five years needed modification). All the patients were followed up for side effects of treatment once per month. The patient outcomes were categorized as good outcomes if they had completed treatment and cured or were improving during the course of treatment, while bad outcomes included death or not improving during the course of treatment. Results: Of the 50 pediatric patients included in the study, 34 were females (66.7%) and 16 were male (31.4%). Around 33 patients (64.7%) were suffering from pulmonary TB, while 17 (33.3%) were suffering from extrapulmonary TB. The proportions of monoresistant TB, polyresistant TB, MDR-TB, pre-XDR-TB and XDR-TB were 2.0%, 0%, 50.0%, 30.0% and 18.0%, respectively. Good outcome was reported in 40 patients (80.0%). The 10 bad outcomes were 7 deaths (14%) and 3 (6.0%) children who were not improving. Adverse events (single or multiple) were reported in all the patients, most of which were mild in nature. The most common adverse events were metallic taste 16(31.4%), rash and allergic reaction 15(29.4%), nausea and vomiting 13(26.0%), arthralgia 11 (21.6%) and alopecia 11 (21.6%). Serious adverse event of QTc prolongation was reported in 4 cases (7.8%), but neither arrhythmias nor symptomatic cardiac side effects occurred. Vestibular toxicity was reported in 2(3.9%), and psychotic symptoms in 4(7.8%). Hepatotoxicity, hypothyroidism, peripheral neuropathy, gynaecomastia, and amenorrhea were reported in 2 (4.0%), 4 (7.8%), 2 (3.9%), 1(2.0%), and 2 (3.9%) respectively. None of the drugs needed to be withdrawn due to uncontrolled adverse events. Conclusion: Paediatric DR TB treatment achieved favorable outcomes in a large proportion of children. DR TB treatment regimen drugs were overall well tolerated in this cohort.

Keywords: pediatric, drug-resistant, tuberculosis, adverse events, treatment

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