Search results for: clinical outcome improvement
Commenced in January 2007
Frequency: Monthly
Edition: International
Paper Count: 8847

Search results for: clinical outcome improvement

8757 Predicting Resistance of Commonly Used Antimicrobials in Urinary Tract Infections: A Decision Tree Analysis

Authors: Meera Tandan, Mohan Timilsina, Martin Cormican, Akke Vellinga

Abstract:

Background: In general practice, many infections are treated empirically without microbiological confirmation. Understanding susceptibility of antimicrobials during empirical prescribing can be helpful to reduce inappropriate prescribing. This study aims to apply a prediction model using a decision tree approach to predict the antimicrobial resistance (AMR) of urinary tract infections (UTI) based on non-clinical features of patients over 65 years. Decision tree models are a novel idea to predict the outcome of AMR at an initial stage. Method: Data was extracted from the database of the microbiological laboratory of the University Hospitals Galway on all antimicrobial susceptibility testing (AST) of urine specimens from patients over the age of 65 from January 2011 to December 2014. The primary endpoint was resistance to common antimicrobials (Nitrofurantoin, trimethoprim, ciprofloxacin, co-amoxiclav and amoxicillin) used to treat UTI. A classification and regression tree (CART) model was generated with the outcome ‘resistant infection’. The importance of each predictor (the number of previous samples, age, gender, location (nursing home, hospital, community) and causative agent) on antimicrobial resistance was estimated. Sensitivity, specificity, negative predictive (NPV) and positive predictive (PPV) values were used to evaluate the performance of the model. Seventy-five percent (75%) of the data were used as a training set and validation of the model was performed with the remaining 25% of the dataset. Results: A total of 9805 UTI patients over 65 years had their urine sample submitted for AST at least once over the four years. E.coli, Klebsiella, Proteus species were the most commonly identified pathogens among the UTI patients without catheter whereas Sertia, Staphylococcus aureus; Enterobacter was common with the catheter. The validated CART model shows slight differences in the sensitivity, specificity, PPV and NPV in between the models with and without the causative organisms. The sensitivity, specificity, PPV and NPV for the model with non-clinical predictors was between 74% and 88% depending on the antimicrobial. Conclusion: The CART models developed using non-clinical predictors have good performance when predicting antimicrobial resistance. These models predict which antimicrobial may be the most appropriate based on non-clinical factors. Other CART models, prospective data collection and validation and an increasing number of non-clinical factors will improve model performance. The presented model provides an alternative approach to decision making on antimicrobial prescribing for UTIs in older patients.

Keywords: antimicrobial resistance, urinary tract infection, prediction, decision tree

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8756 Nano Fat Injection for Scar Treatment and Skin Rejuvenation

Authors: Sokol Isaraj, Lorela Bendo

Abstract:

Scars resulting from surgery, injury, or burns have a physical and psychological impact on the affected patient. Although a number of treatments are available, nano fat grafting is an effective treatment for scars. Nano fat is a liquid suspension rich in stem cells obtained by mechanical emulsification. Nano fat grafting was performed in 10 cases to correct rhytides, surgical scars, and post-burn scars between January 2022 and April 2022. Fat was aspirated from the lower abdomen or trochanteric region. After emulsification and filtration protocol, the resulting nano fat liquid was injected intradermally and subdermally. All patients filled out a questionnaire at three months post-treatment, which consisted of questions regarding the grade of improvement of skin and recommendation of the procedure. The clinical results were apparent between 2 and 3 weeks after the treatment. All patients confirmed an improvement in skin texture and quality. The most significant improvement was seen in pigmentation and pliability. No complications were reported. Nano fat seems to be a safe and effective treatment in scar treatment and skin rejuvenation.

Keywords: fat grafting, fat transfer, micro fat, nano fat

Procedia PDF Downloads 61
8755 The Effects of L-Arginine Supplementation on Clinical Symptoms, Quality of Life, and Anal Internal Sphincter Pressure in Patients with Chronic Anal Fissure

Authors: Masoumeh Khailghi Sikaroudi, Mohsen Masoodi, Fazad Shidfar, Meghdad Sedaghat

Abstract:

Background: The hypertonicity of internal anal sphincter resting pressure is one of the main reasons for chronic anal fissures. The aim of this study is to assess the effect of oral administration of L-arginine on anal fissure symptom improvement by relaxation of the internal anal sphincter. Method: Seventy-six chronic anal fissure patients (age: 18-65 years) took part in this randomized, double-blind, placebo-controlled trial study from February 2019 to October 2020 at Rasoul-e-Akram Hospital, Tehran, Iran. Participants were allocated into treatment (L-arginine) or placebo groups. They took a 1000 mg capsule three times a day for one month and were followed up at the end of the first and third months after receiving the intervention. Clinical symptoms, anal sphincter resting pressure, and quality of life (QoL) were completed at baseline and the end of the study. Result: The analysis of data was shown significant improvement in bleeding, fissure size, and pain within each group; however, this effect was more seen in the arginine group compared to the control group at the end of the study (P-values<0.001). Following that, a significant increase in QoL was seen just in patients who were treated with arginine (P-value=0.006). Also, the comparison of anal pressures to baseline and between groups at the end of the study showed a significant reduction in sphincter pressure in treated patients (P-value<0.001, =0.049; respectively). Conclusion: Oral administration of 3000 mg L-arginine can heal chronic anal fissures by reducing anal internal sphincter pressure with fewer side effects. However, a long-term study with more follow-up is recommended.

Keywords: L-arginine, anal fissure, sphincter pressure, clinical symptoms, quality of life

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8754 Case Report: Clinical Improvement of Forbrain Neurologic Signs in 3- Month- Old Persian Mastiff Dog with Calvarial Hyperostosis Syndrome after Corticosteroid, Antiepileptic and Antibiotic Therapy

Authors: Hamidreza Jahani, Zahra Salehzadeh, Ehsan Amini, Mohsen Tohidifar

Abstract:

Calvarial Hyperostosis Syndrome (CHS) is a benign bone disease of the skull. It is a non-neoplastic and proliferative bone disease, and the main feature of the disease is progressive and asymmetrical bone involvement. CHS is mostly reported in young male and female bullmastiff dogs and less frequently in other breeds. The etiology of CHS is unknown. This is the first case report of CHS in Iran. A 3-month-old male Persian Mastiff was presented with chief complaints of multiple episodes of seizure, pacing, bizarre behavior, delayed growth, head pressing, and difficulty in opening the mouth. Central blindness and open fontanelles were observed in clinical examination. No abnormality was found in the complete blood count and routine blood biochemical tests. CT scan findings include cortical thickening of frontal and parietal bones and enlargement of the left retropharyngeal lymph node. For treatment, oral clindamycin for two weeks, prednisolone and phenobarbital for one month, respectively, were administrated, and the case showed improvement after a week and recovered after one month.

Keywords: calvarial hyperostosis, Persian Mastiff, frontal bone, seizure

Procedia PDF Downloads 117
8753 Nano Fat Injection for Scar Treatment and Skin Rejuvenation

Authors: Sokol Isaraj, Lorela Bendo

Abstract:

Scars resulting from surgery, injury, or burns have a physical and psychological impact on the affected patient. Although a number of treatments are available, nano fat grafting is an effective treatment for scars. Nano fat is a liquid suspension rich in stem cells obtained by mechanical emulsification. Nano fat grafting was performed in 10 cases to correct rhytides, surgical scars and post-burn scars between January 2022 and April 2022. Fat was aspirated from the lower abdomen or trochanteric region. After emulsification and filtration protocol, the resulting nano fat liquid was injected intradermally and subdermally. All patients filled out a questionnaire at 3 months post-treatment which consisted of questions regarding the grade of improvement of skin and recommendation of the procedure. The clinical results were apparent between 2 and 3 weeks after the treatment. All patients confirmed an improvement in skin texture and quality. The most significant improvement was seen in pigmentation and pliability. No complications were reported. Nano fat seems to be a safe and effective treatment for scar treatment and skin rejuvenation.

Keywords: fat grafting, fat transfer, microfat, nanofat

Procedia PDF Downloads 63
8752 Maternal-Fetal Outcome in Pregnant Women with Ebola Virus Disease: A Systematic Review

Authors: Garba Iliyasu, Lamaran Dattijo

Abstract:

Introduction: Ebola virus disease (EVD) is a disease of humans and other primates caused by Ebola viruses. The most widespread epidemic of EVD in history occurred recently in several West African countries. The burden and outcome of EVD in pregnant women remains uncertain. There are very few studies to date reporting on maternal and fetal outcomes among pregnant women with EVD, hence the justification for this comprehensive review of these published studies. Methods: Published studies in English that reported on maternal and or fetal outcome among pregnant women with EVD up to May 2016 were searched in electronic databases (Google Scholar, Medline, Embase, PubMed, AJOL, and Scopus). Studies that did not satisfy the inclusion criteria were excluded. We extracted the following variables from each study: geographical location, year of the study, settings of the study, participants, maternal and fetal outcome.Result: There were 12 studies that reported on 108 pregnant women and 110 fetal outcomes. Six of the studies were case reports, 3 retrospective studies, 2 cross-sectional studies and 1 was a technical report. There were 91(84.3%) deaths out of the 108 pregnant women, while only 1(0.9%) fetal survival was reported out of 110. Survival rate among the 15 patients that had spontaneous abortion/stillbirth or induced delivery was 100%. Conclusion: There was a poor maternal and fetal outcome among pregnant women with EVD, and fetal evacuation significantly improves maternal survival.

Keywords: Africa, ebola, maternofetal, outcome

Procedia PDF Downloads 244
8751 Interactive Virtual Patient Simulation Enhances Pharmacology Education and Clinical Practice

Authors: Lyndsee Baumann-Birkbeck, Sohil A. Khan, Shailendra Anoopkumar-Dukie, Gary D. Grant

Abstract:

Technology-enhanced education tools are being rapidly integrated into health programs globally. These tools provide an interactive platform for students and can be used to deliver topics in various modes including games and simulations. Simulations are of particular interest to healthcare education, where they are employed to enhance clinical knowledge and help to bridge the gap between theory and practice. Simulations will often assess competencies for practical tasks, yet limited research examines the effects of simulation on student perceptions of their learning. The aim of this study was to determine the effects of an interactive virtual patient simulation for pharmacology education and clinical practice on student knowledge, skills and confidence. Ethics approval for the study was obtained from Griffith University Research Ethics Committee (PHM/11/14/HREC). The simulation was intended to replicate the pharmacy environment and patient interaction. The content was designed to enhance knowledge of proton-pump inhibitor pharmacology, role in therapeutics and safe supply to patients. The tool was deployed into a third-year clinical pharmacology and therapeutics course. A number of core practice areas were examined including the competency domains of questioning, counselling, referral and product provision. Baseline measures of student self-reported knowledge, skills and confidence were taken prior to the simulation using a specifically designed questionnaire. A more extensive questionnaire was deployed following the virtual patient simulation, which also included measures of student engagement with the activity. A quiz assessing student factual and conceptual knowledge of proton-pump inhibitor pharmacology and related counselling information was also included in both questionnaires. Sixty-one students (response rate >95%) from two cohorts (2014 and 2015) participated in the study. Chi-square analyses were performed and data analysed using Fishers exact test. Results demonstrate that student knowledge, skills and confidence within the competency domains of questioning, counselling, referral and product provision, show improvement following the implementation of the virtual patient simulation. Statistically significant (p<0.05) improvement occurred in ten of the possible twelve self-reported measurement areas. Greatest magnitude of improvement occurred in the area of counselling (student confidence p<0.0001). Student confidence in all domains (questioning, counselling, referral and product provision) showed a marked increase. Student performance in the quiz also improved, demonstrating a 10% improvement overall for pharmacology knowledge and clinical practice following the simulation. Overall, 85% of students reported the simulation to be engaging and 93% of students felt the virtual patient simulation enhanced learning. The data suggests that the interactive virtual patient simulation developed for clinical pharmacology and therapeutics education enhanced students knowledge, skill and confidence, with respect to the competency domains of questioning, counselling, referral and product provision. These self-reported measures appear to translate to learning outcomes, as demonstrated by the improved student performance in the quiz assessment item. Future research of education using virtual simulation should seek to incorporate modern quantitative measures of student learning and engagement, such as eye tracking.

Keywords: clinical simulation, education, pharmacology, simulation, virtual learning

Procedia PDF Downloads 309
8750 Predictors of Glycaemic Variability and Its Association with Mortality in Critically Ill Patients with or without Diabetes

Authors: Haoming Ma, Guo Yu, Peiru Zhou

Abstract:

Background: Previous studies show that dysglycemia, mostly hyperglycemia, hypoglycemia and glycemic variability(GV), are associated with excess mortality in critically ill patients, especially those without diabetes. Glycemic variability is an increasingly important measure of glucose control in the intensive care unit (ICU) due to this association. However, there is limited data pertaining to the relationship between different clinical factors and glycemic variability and clinical outcomes categorized by their DM status. This retrospective study of 958 intensive care unit(ICU) patients was conducted to investigate the relationship between GV and outcome in critically ill patients and further to determine the significant factors that contribute to the glycemic variability. Aim: We hypothesize that the factors contributing to mortality and the glycemic variability are different from critically ill patients with or without diabetes. And the primary aim of this study was to determine which dysglycemia (hyperglycemia\hypoglycemia\glycemic variability) is independently associated with an increase in mortality among critically ill patients in different groups (DM/Non-DM). Secondary objectives were to further investigate any factors affecting the glycemic variability in two groups. Method: A total of 958 diabetic and non-diabetic patients with severe diseases in the ICU were selected for this retrospective analysis. The glycemic variability was defined as the coefficient of variation (CV) of blood glucose. The main outcome was death during hospitalization. The secondary outcome was GV. The logistic regression model was used to identify factors associated with mortality. The relationships between GV and other variables were investigated using linear regression analysis. Results: Information on age, APACHE II score, GV, gender, in-ICU treatment and nutrition was available for 958 subjects. Predictors remaining in the final logistic regression model for mortality were significantly different in DM/Non-DM groups. Glycemic variability was associated with an increase in mortality in both DM(odds ratio 1.05; 95%CI:1.03-1.08,p<0.001) or Non-DM group(odds ratio 1.07; 95%CI:1.03-1.11,p=0.002). For critically ill patients without diabetes, factors associated with glycemic variability included APACHE II score(regression coefficient, 95%CI:0.29,0.22-0.36,p<0.001), Mean BG(0.73,0.46-1.01,p<0.001), total parenteral nutrition(2.87,1.57-4.17,p<0.001), serum albumin(-0.18,-0.271 to -0.082,p<0.001), insulin treatment(2.18,0.81-3.55,p=0.002) and duration of ventilation(0.006,0.002-1.010,p=0.003).However, for diabetes patients, APACHE II score(0.203,0.096-0.310,p<0.001), mean BG(0.503,0.138-0.869,p=0.007) and duration of diabetes(0.167,0.033-0.301,p=0.015) remained as independent risk factors of GV. Conclusion: We found that the relation between dysglycemia and mortality is different in the diabetes and non-diabetes groups. And we confirm that GV was associated with excess mortality in DM or Non-DM patients. Furthermore, APACHE II score, Mean BG, total parenteral nutrition, serum albumin, insulin treatment and duration of ventilation were significantly associated with an increase in GV in Non-DM patients. While APACHE II score, mean BG and duration of diabetes (years) remained as independent risk factors of increased GV in DM patients. These findings provide important context for further prospective trials investigating the effect of different clinical factors in critically ill patients with or without diabetes.

Keywords: diabetes, glycemic variability, predictors, severe disease

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8749 Nutritional Profile and Food Intake Trends amongst Hospital Dieted Diabetic Eye Disease Patients of India

Authors: Parmeet Kaur, Nighat Yaseen Sofi, Shakti Kumar Gupta, Veena Pandey, Rajvaedhan Azad

Abstract:

Nutritional status and prevailing blood glucose level trends amongst hospitalized patients has been linked to clinical outcome. Therefore, the present study was undertaken to assess hospitalized Diabetic Eye Disease (DED) patients' anthropometric and dietary intake trends. DED patients with type 1 or 2 diabetes > 20 years were enrolled. Actual food intake was determined by weighed food record method. Mifflin St Joer predictive equation multiplied by a combined stress and activity factor of 1.3 was applied to estimate caloric needs. A questionnaire was further administered to obtain reasons of inadequate dietary intake. Results indicated validity of joint analyses of body mass index in combination with waist circumference for clinical risk prediction. Dietary data showed a significant difference (p < 0.0005) between average daily caloric and carbohydrate intake and actual daily caloric and carbohydrate needs. Mean fasting and post-prandial plasma glucose levels were 150.71 ± 72.200 mg/dL and 219.76 ± 97.365 mg/dL, respectively. Improvement in food delivery systems and nutrition educations were indicated for reducing plate waste and to enable better understanding of dietary aspects of diabetes management. A team approach of nurses, physicians and other health care providers is required besides the expertise of dietetics professional. To conclude, findings of the present study will be useful in planning nutritional care process (NCP) for optimizing glucose control as a component of quality medical nutrition therapy (MNT) in hospitalized DED patients.

Keywords: nutritional status, diabetic eye disease, nutrition care process, medical nutrition therapy

Procedia PDF Downloads 335
8748 Analytical-Behavioral Intervention for Women with Fibromyalgia: Evaluation of Effectiveness Clinical Significance and Reliable Change

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

Abstract:

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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8747 Combine Resection of Talocalcaneal Tarsal Coalition and Calcaneal Lengthening Osteotomy. Short-to-Intermediate Term Results

Authors: Naum Simanovsky, Vladimir Goldman, Michael Zaidman

Abstract:

Background: The optimal algorithm for the management of symptomatic tarsal coalition is still under discussion in pediatric literature. It's debatable what surgical steps are essential to achieve the best outcome. Method: The investigators retrospectively reviewed the records of twelve patients with symptomatic tarsal coalition that were treated operatively between 2017 and 2019. Only painful flat feet were operated. Two patients were excluded from the study due to lack of sufficient follow-up. Ten of eleven feet were treated with the combination of calcaneal lengthening osteotomy (CLO) and resection of coalition (RC). Only one foot was operated with CLO alone. In half of our patients, Achilles lengthening was performed. For two children, medial plication was added. Short leg cast was applied to all children for 6-8 weeks, and soft shoe insoles for medial arch support were prescribed after. Demographic, clinical, and radiographic records were reviewed. The outcome was evaluated using American Orthopedic Foot and Ankle Society (AOFAS) Ankle Hindfoot Score. Results: There were seven boys and three girls. The mean age at the time of surgery was 13.9 (range 12 to 17) years, and the mean follow-up was 18 (range 8 to 34) months. The early complications included one superficial wound infection and dehiscence. Late complication includes two children with residual forefoot supination. None of our patients required additional operations during the follow-up period. All feet achieved complete deformity correction or dramatic improvement. In the last follow-up, seven feet were painless, and four children had some mild pain after intensive activities. All feet achieved excellent and good scoring on AOFAS. Conclusions: Many patients with talocalcaneal coalition also have rigid or stiff, painful, flat feet. For these patients, the resection of coalition with concomitant CLO can be safely recommended.

Keywords: Tarsal coalition, calcaneal lengthening osteotomy., flat foot, coalition resection

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8746 Assessing Perinatal Mental Illness during the COVID-19 Pandemic: A Review of Measurement Tools

Authors: Mya Achike

Abstract:

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

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

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8745 Patient-Specific Modeling Algorithm for Medical Data Based on AUC

Authors: Guilherme Ribeiro, Alexandre Oliveira, Antonio Ferreira, Shyam Visweswaran, Gregory Cooper

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Patient-specific models are instance-based learning algorithms that take advantage of the particular features of the patient case at hand to predict an outcome. We introduce two patient-specific algorithms based on decision tree paradigm that use AUC as a metric to select an attribute. We apply the patient specific algorithms to predict outcomes in several datasets, including medical datasets. Compared to the patient-specific decision path (PSDP) entropy-based and CART methods, the AUC-based patient-specific decision path models performed equivalently on area under the ROC curve (AUC). Our results provide support for patient-specific methods being a promising approach for making clinical predictions.

Keywords: approach instance-based, area under the ROC curve, patient-specific decision path, clinical predictions

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8744 Continuous Improvement in Emerging Economies: Insights from a Multi-Case Analysis

Authors: Luis A. Paipa-Galeano, Yavar Jarrah-Nezhad, César A. Bernal-Torres

Abstract:

This paper presents a case study of four companies in an emerging economy to identify the key success factors and barriers to sustaining continuous improvement practices. The study analyzes the empirical evidence and compares it to the literature review to provide insights for companies looking to increase their maturity level in this area. The five success factors identified are the availability of resources, commitment and support from management, participation of employees in identifying tasks to improve, clear and realistic objectives for continuous improvement, and the existence of a leader or responsible for continuous improvement. The major barriers to success are a lack of alignment between the organization’s strategic objectives and continuous improvement objectives, a lack of motivation in the team, and resistance to change. The paper concludes with recommendations for companies to reduce the risk of improvement failure and increase their maturity level in continuous improvement.

Keywords: emerging economies, Kaizen, continuous improvement sustainability, maturity model

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8743 Need of Trained Clinical Research Professionals Globally to Conduct Clinical Trials

Authors: Tambe Daniel Atem

Abstract:

Background: Clinical Research is an organized research on human beings intended to provide adequate information on the drug use as a therapeutic agent on its safety and efficacy. The significance of the study is to educate the global health and life science graduates in Clinical Research in depth to perform better as it involves testing drugs on human beings. Objectives: to provide an overall understanding of the scientific approach to the evaluation of new and existing medical interventions and to apply ethical and regulatory principles appropriate to any individual research. Methodology: It is based on – Primary data analysis and Secondary data analysis. Primary data analysis: means the collection of data from journals, the internet, and other online sources. Secondary data analysis: a survey was conducted with a questionnaire to interview the Clinical Research Professionals to understand the need of training to perform clinical trials globally. The questionnaire consisted details of the professionals working with the expertise. It also included the areas of clinical research which needed intense training before entering into hardcore clinical research domain. Results: The Clinical Trials market worldwide worth over USD 26 billion and the industry has employed an estimated 2,10,000 people in the US and over 70,000 in the U.K, and they form one-third of the total research and development staff. There are more than 2,50,000 vacant positions globally with salary variations in the regions for a Clinical Research Coordinator. R&D cost on new drug development is estimated at US$ 70-85 billion. The cost of doing clinical trials for a new drug is US$ 200-250 million. Due to an increase trained Clinical Research Professionals India has emerged as a global hub for clinical research. The Global Clinical Trial outsourcing opportunity in India in the pharmaceutical industry increased to more than $2 billion in 2014 due to increased outsourcing from U.S and Europe to India. Conclusion: Assessment of training need is recommended for newer Clinical Research Professionals and trial sites, especially prior the conduct of larger confirmatory clinical trials.

Keywords: clinical research, clinical trials, clinical research professionals

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8742 Plantar Neuro-Receptor Activation in Total Knee Arthroplasty Patients: Impact on Clinical Function, Pain, and Stiffness - A Randomized Controlled Trial

Authors: Woolfrey K., Woolfrey M., Bolton C. L., Warchuk D.

Abstract:

Objectives: Osteoarthritis is the most common joint disease of adults worldwide. Despite total knee arthroplasty (TKA) demonstrating high levels of success, 20% of patients report dissatisfaction with their result. VOXX Wellness Stasis Socks are embedded with a proprietary pattern of neuro-receptor activation points that have been proven to activate a precise neuro-response, according to the pattern theory of haptic perception, which stimulates improvements in pain and function. The use of this technology in TKA patients may prove beneficial as an adjunct to recovery as many patients suffer from deficits to their proprioceptive system caused by ligamentous damage and alterations to mechanoreceptors during the procedure. We hypothesized that VOXX Wellness Stasis Socks are a safe, cost-effective, and easily scalable strategy to support TKA patients through their recovery. Design: Double-blinded, placebo-controlled randomized trial. Participants: Patients scheduled to receive TKA were considered eligible for inclusion in the trial. Interventions: Intervention group (I): VOXX Wellness Stasis socks containing receptor point-activation technology. Control group (C): VOXX Wellness Stasis socks without receptor point-activation technology. Sock use during the waking hours x 6 weeks. Main Outcome Measures: Western Ontario McMaster Universities Osteoarthritis Index (WOMAC) questionnaire completed at baseline, 2 weeks, and 6 weeks to assess pain, stiffness, and physical function. Results: Data analysis using SPSS software. P-values, effect sizes, and confidence intervals are reported to assess clinical relevance of the finding. Physical status classifications were compared using t-test. Within-subject and between-subject differences in the mean WOMAC were analyzed by ANOVA. Effect size was analyzed using Cramer’s V. Consistent improvement in WOMAC scores for pain and stiffness at 2 weeks post op in the I over the C group. The womac scores assessing physical function showed a consistent improvement at both 2 and 6 weeks post op in the I group compared to C group. Conclusions: VOXX proved to be a low cost, safe intervention in TKA to help patients improve with regard to pain, stiffness, and physical function. Disclosures: None

Keywords: osteoarthritis, RCT, pain management, total knee arthroplasty

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8741 A Clinical Study of Placenta Previa and Its Effect on Fetomaternal Outcome in Scarred and Unscarred Uterus at a Tertiary Care Hospital

Authors: Sharadha G., Suresh Kanakkanavar

Abstract:

Background: Placenta previa is a condition characterized by partial or complete implantation of the placenta in the lower uterine segment. It is one of the main causes of vaginal bleeding in the third trimester and a significant cause of maternal and perinatal morbidity and mortality. Materials and Methods: This is an observational study involving 130 patients diagnosed with placenta previa and satisfying inclusion criteria. The demographic data, clinical, surgical, and treatment, along with maternal and neonatal outcome parameters, were noted in proforma. Results: The incidence of placenta previa among scarred uterus was 1.32%, and in unscarred uterus was 0.67%. The mean age of the study population was 27.12±4.426years. High parity, high abortion rate, multigravida status, and less gestational age at delivery were commonly seen in scarred uterus compared to unscarred uterus. Complete placenta previa, anterior placental position, and adherent placenta were significantly associated with a scarred uterus compared to an unscarred uterus. The rate of caesarean hysterectomy was higher in the scarred uterus, along with statistical association to previous lower-segment caesarean sections. Intraoperative procedures like uterine artery ligation, bakri balloon insertion, and iliac artery ligation were higher in the scarred group. The maternal intensive care unit admission rate was higher in the scarred group and also showed its statistical association with previous lower segment caesarean section. Neonatal outcomes in terms of pre-term birth, still birth, neonatal intensive care unit admission, and neonatal death, though higher in the scarred group, did not differ statistically among the groups. Conclusion: Advancing maternal age, multiparity, prior uterine surgeries, and abortions are independent risk factors for placenta previa. Maternal morbidity is higher in the scarred uterus group compared to the unscarred group. Neonatal outcomes did not differ statistically among the groups. This knowledge would help the obstetricians to take measures to reduce the incidence of placenta previa and scarred uterus which would improve the fetomaternal outcome of placenta previa.

Keywords: placenta previa, scarred uterus, unscarred uterus, adherent placenta

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8740 To Prepare a Remedial Teaching Programme for Dyslexic Students of English and Marathi Medium Schools and Study Its Effect on Their Learning Outcome

Authors: Khan Zeenat, S. B. Dandegaonkar

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Dyslexia is a neurological disorder which affects the reading and writing ability of children. A sample of 72 dyslexic children (36 from English medium and 36 from Marathi medium schools) of class V from English and Marathi medium schools were selected. The Experimental method was used to study the effect of Remedial Teaching Programme on the Learning outcome of Dyslexic students. The findings showed that there is a Positive effect of remedial teaching programme on the Learning outcome of English and Marathi medium students.

Keywords: remedial teaching, Dyslexic students, learning outcome, neurological

Procedia PDF Downloads 501
8739 Quantitative and Qualitative Analysis of Randomized Controlled Trials in Physiotherapy from India

Authors: K. Hariohm, V. Prakash, J. Saravana Kumar

Abstract:

Introduction and Rationale: Increased scope of Physiotherapy (PT) practice also has contributed to research in the field of PT. It is essential to determine the production and quality of the clinical trials from India since, it may reflect the scientific growth of the profession. These trends can be taken as a baseline to measure our performance and also can be used as a guideline for the future trials. Objective: To quantify and analyze qualitatively the RCT’s from India from the period 2000-2013’ May, and classify data for the information process. Methods: Studies were searched in the Medline database using the key terms “India”, “Indian”, “Physiotherapy”. Clinical trials only with PT authors were included. Trials out of scope of PT practice and on animals were excluded. Retrieved valid articles were analyzed for published year, type of participants, area of study, PEDro score, outcome measure domains of impairment, activity, participation; ‘a priori’ sample size calculation, region, and explanation of the intervention. Result: 45 valid articles were retrieved from the year 2000-2013’ May. The majority of articles were done on symptomatic participants (81%). The frequencies of conditions repeated more were low back pain (n-7) and diabetes (n-4). PEDro score with mode 5 and upper limit of 8 and lower limit 4 was found. 97.2% of studies measure the outcome at the impairment level, 34% in activity level, and 27.8% in participation level. 29.7% of studies did ‘a priori’ sample size calculation. Correlation of year trend and PEDro score found to be not significant (p>.05). Individual PEDro item analysis showed, randomization (100%), concealment (33%) baseline (76%), blinding-subject, therapist, assessor (9.1%, 0%, 10%), follow-up (89%) ITT (15%), statistics between groups (100%), measures of variance (88 %). Conclusion: The trend shows an upward slope in terms of RCTs published from India which is a good indicator. The qualitative analysis showed some gaps in the clinical trial design, which can be expected to be, fulfilled by the future researchers.

Keywords: RCT, PEDro, physical therapy, rehabilitation

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8738 SWOT Analysis of the Industrial Sector in Kuwait

Authors: Abdullah Al-Alaian, Ahmad Al-Enzi, Hasan Al-Herz, Ahmad Bakri, Shant Tatorian, Amr Nounou

Abstract:

Kuwait is a country that has an imbalanced economy since most of its national outcome comes from the oil trade. It is so risky for a country to be dependent on a single source for income, and this increases the need to diversify its economy. In addition, according to the Public Authority for Industry, the contribution of the industrial sector to the current Gross Domestic Product (GDP) of Kuwait is low which is about 4.33%. Therefore, the development of the industrial sector can be one of the means to diversify the economy and increase the industry's contribution to the national outcome. This is in accordance with Kuwait’s vision of 2035 which aims at increasing the contribution of the industrial sector to the GDP to 12%. In order to do so, this study aims at proposing a strategic plan that will accomplish certain objectives when implemented. It is based on analyzing the industrial sectors in Kuwait taking into consideration studying the strengths, weaknesses, opportunities, and threats facing them. At the same time, it tends to gain from the experience of leading models and neighboring countries regarding the development of the industrial sector. In this study, the SWOT analysis technique will be conducted on all industrial sectors based on evaluation criteria in which it is determined whether any of them has a potential for improvement or not. In other words, it is determined whether the sectors are able to compete locally, regionally, or globally. Based on the results of the SWOT analysis, certain sectors will be chosen, assessed based on an assessment scheme, and their potentials for improvement will be aligned with the overall objectives. To ensure the achievement of the study’s objectives, an action plan will be proposed regarding recommendations for the related authorities, and for entrepreneurs. In addition, monitoring tools are going to be provided for the purpose of periodically checking the progress made in the implementation of the plan.

Keywords: industrial sector, SWOT analysis, productivity, competitiveness, GDP, Kuwait, economy

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8737 Treatment Outcome Of Corneal Ulcers Using Levofloxacin Hydrate 1.5% Ophthalmic Solution And Adjuvant Oral Ciprofloxacin, A Treatment Strategy Applicable To Primary Healthcare

Authors: Celine Shi Ying Lee, Jong Jian Lee

Abstract:

Background: Infectious keratitis is one of the leading causes of blindness worldwide. Prompt treatment with effective medication will control the infection early, preventing corneal scarring and visual loss. fluoroquinolones ophthalmic medication is used because of its broad-spectrum properties, potency, good intraocular penetration, and low toxicity. The study aims to evaluate the treatment outcome of corneal ulcers using Levofloxacin 1.5% ophthalmic solution (LVFX) with adjuvant oral ciprofloxacin when indicated and apply this treatment strategy in primary health care as first-line treatment. Methods: Patients with infective corneal ulcer treated in an eye center were recruited. Inclusion criteria includes Corneal infection consistent with bacterial keratitis, single or multiple small corneal ulcers. Treatment regime: LVFX hourly for the first 2 days, 2 hourly from the 3rd day, and 3 hourly on the 5th day of review. Adjuvant oral ciprofloxacin 500mg BD was administered for 5 days if there were multiple corneal ulcers or when the location of the cornea ulcer was central or paracentral. Results: 47 subjects were recruited. There were 16 (34%) males and 31 (66%) females. 40 subjects (85%) were contact lens (CL) related to corneal ulcer, and 7 subjects (15%) were non-contact lens related. 42 subjects (89%) presented with one ulcer, of which 20 of them (48%) needed adjuvant therapy. 5 subjects presented with 2 or 3 ulcers, of which 3 needed adjuvant therapy. A total of 23 subjects (49%) was given adjuvant therapy (oral ciprofloxacin 500mg BD for 5 days).21 of them (91%) were CL related. All subjects recovered fully, and the average duration of treatment was 3.7 days, with 49% of the subjects resolved on the 3rd day, 38% on the 5thday of and 13% on the 7thday. All subjects showed symptoms of relief of pain, light-sensitivity, and redness on the 3rd day with full visual recovery post-treatment. No adverse drug reactions were recorded. Conclusion: Our treatment regime demonstrated good clinical outcome as first-line treatment for corneal ulcers. A corneal ulcer is a common eye condition in Singapore, mainly due to CL wear. Pseudomonas aeruginosa is the most frequent and potentially sight-threatening pathogen involved in CL related corneal ulcer. Coagulase-negative Staphylococci, Staphylococcus aureus, and Streptococcus Pneumoniae were seen in non-CL users. All these bacteria exhibit good sensitivity rates to ciprofloxacin and levofloxacin. It is therefore logical in our study to use LVFX Eyedrops and adjuvant ciprofloxacin oral antibiotics when indicated as first line treatment for most corneal ulcers. Our study of patients, both CL related and non-CL related, have shown good clinical response and full recovery using the above treatment strategy. There was also a full restoration of visual acuity in all the patients. Eye-trained primary Healthcare practitioners can consider adopting this treatment strategy as first line treatment in patients with corneal ulcers. This is relevant during the COVID pandemic, where hospitals are overwhelmed with patients and in regions with limited access to specialist eye care. This strategy would enable early treatment with better clinical outcome.

Keywords: corneal ulcer, levofloxacin hydrate, treatment strategy, ciprofloxacin

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8736 Application of Latent Class Analysis and Self-Organizing Maps for the Prediction of Treatment Outcomes for Chronic Fatigue Syndrome

Authors: Ben Clapperton, Daniel Stahl, Kimberley Goldsmith, Trudie Chalder

Abstract:

Chronic fatigue syndrome (CFS) is a condition characterised by chronic disabling fatigue and other symptoms that currently can't be explained by any underlying medical condition. Although clinical trials support the effectiveness of cognitive behaviour therapy (CBT), the success rate for individual patients is modest. Patients vary in their response and little is known which factors predict or moderate treatment outcomes. The aim of the project is to develop a prediction model from baseline characteristics of patients, such as demographics, clinical and psychological variables, which may predict likely treatment outcome and provide guidance for clinical decision making and help clinicians to recommend the best treatment. The project is aimed at identifying subgroups of patients with similar baseline characteristics that are predictive of treatment effects using modern cluster analyses and data mining machine learning algorithms. The characteristics of these groups will then be used to inform the types of individuals who benefit from a specific treatment. In addition, results will provide a better understanding of for whom the treatment works. The suitability of different clustering methods to identify subgroups and their response to different treatments of CFS patients is compared.

Keywords: chronic fatigue syndrome, latent class analysis, prediction modelling, self-organizing maps

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8735 Visual Outcome After 360-Degree Retinectomy in Total Rhegmatogenous Retinal Detachment with Advanced Proliferative Vitreoretinopathy: A Case Series

Authors: Andriati Nadhilah Widyarini, Ezra Margareth

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Introduction: Rhegmatogenous retinal detachment is a condition where there’s a break in the retina, which allows the vitreous to directly enter the subretinal space. Proliferative vitreoretinopathy (PVR) may develop due to this condition and can result in a new break, which could cause traction on the previously detached retina. Various methods of therapy can be done to treat this complication. Case: This case series involved 2 eyes of 2 patients who had total retinal detachment with advanced PVR. Pars plana vitrectomy was performed, and a 360-degree retinectomy procedure with perfluorocarbon liquid usage was done. This was followed by endo laser retinopexy to surround the border of retinectomy. 5000 cs silicone oil was used in 1 eye, whereas 12% of perfluoropropane gas was used in the other eye as a tamponade. These procedures were performed with meticulous attention to prevent any fluid from entering the subretinal space. Postoperative examination showed attachment of the retina and improvement of the patient’s visual acuity. Both eyes’ intraocular pressure was in the normal range. One eye developed retinal displacement, but no other complications occurred. Discussion: Rhegmatogenous retinal detachment with advanced PVR is a complex situation for vitreoretinal surgeons. PVR is characterized by the growth and migration of preretinal or subretinal membranes. PVR is the most common cause of retinal reattachment failure. A 360-degree retinectomy is an alternative surgical method to overcome this condition. Objectives of this procedure are releasing retinal traction caused by PVR, reducing the recurrence rate of PVR, and reattaching the retina to the pigment epithelial surface. Conclusion: 360-degree retinectomy provides satisfactory retinal reattachment and visual outcome improvement in rhegmatogenous retinal detachment with advanced PVR.

Keywords: RRD, retinectomy, pars plana, advanced PVR

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8734 Improvement of Deficient Soils in Nigeria Using Bagasse Ash - A Review

Authors: Musa Alhassan, Alhaji Mohammed Mustapha

Abstract:

Review of studies carried out on the use of bagasse ash in the improvement of deficient soils in Nigeria, with emphasis on lateritic and black cotton soils is presented. Although, the bagasse ash is mostly used as additive to the conventional soil stabilizer (cement and lime), the studies generally showed improvement of geotechnical properties of the soils either modified or stabilized with the ash. This showed the potentials of using this agricultural waste (bagasse ash) in the improvement of geotechnical properties of deficient soils. Thus suggesting that using this material at large scale level, in geotechnical engineering practice could help in the provision of stable and durable structures, reduce cost of soil improvement and also reduces environmental nuisance caused by the unused waste in Nigeria

Keywords: bagasse ash, black cotton soil, deficient soil, laterite, soil improvement

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8733 Asthma Nurse Specialist Improves the Management of Acute Asthma in a University Teaching Hospital: A Quality Improvement Project

Authors: T. Suleiman, C. Mchugh, H. Ranu

Abstract:

Background; Asthma continues to be associated with poor patient outcomes, including mortality. An audit of the management of acute asthma admissions in our hospital in 2020 found poor compliance with National Asthma and COPD Audit Project (NACAP) standards which set out to improve inpatient asthma care. Clinical nurse specialists have been shown to improve patient care across a range of specialties. In September 2021, an asthma Nurse Specialist (ANS) was employed in our hospital. Aim; To re-audit management of acute asthma admissions using NACAP standards and assess for quality improvement post-employment of an ANS. Methodology; NACAP standards are wide-reaching; therefore, we focused on ‘specific elements of good practice’ in addition to the provision of inhaled corticosteroids (ICS) on discharge. Medical notes were retrospectively requested from the hospital coding department and selected as per NACAP inclusion criteria. Data collection and entry into the NACAP database were carried out. As this was a clinical audit, ethics approval was not required. Results; Cycle 1 (pre-ANS) and 2 (post-ANS) of the audit included 20 and 32 patients, respectively, with comparable baseline demographics. No patients had a discharge bundle completed on discharge in cycle 1 vs. 84% of cases in cycle 2. Regarding specific components of the bundle, 25% of patients in cycle 1 had their inhaler technique checked vs. 91% in cycle 2. Furthermore, 80% of patients had maintenance medications reviewed in cycle 1 vs. 97% in cycle 2. Medication adherence was addressed in 20% of cases in cycle 1 vs. 88% of cases in cycle 2. Personalized asthma action plans were not issued or reviewed in any cases in cycle 1 as compared with 84% of cases in cycle 2. Triggers were discussed in 30% of cases in cycle 1 vs. 88% of cases in cycle 2. Tobacco dependence was addressed in 44% of cases in cycle 1 vs. 100% of cases in cycle 2. No patients in cycle 1 had community follow-up requested within 2 days vs. 81% of the patients in cycle 2. Similarly, 20% of the patients in cycle 1 vs. 88% of the patients in cycle 2 had a 4-week asthma clinic follow-up requested. 75% of patients in cycle 1 were the recipient of ICS on discharge compared with 94% of patients in cycle 2. Conclusion; Our quality improvement project demonstrates the utility of an ANS in improving performance in the management of acute asthma admissions, evidenced here through concordance with NACAP standards. Asthma is a complex condition with biological, psychological, and sociological components; therefore, ANS is a suitable intervention to improve concordance with guidelines. ANS likely impacted performance directly, for example, by checking inhaler technique, and indirectly as a safety net ensuring doctors included ICS on discharge.

Keywords: asthma, nurse specialist, clinical audit, quality improvement

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8732 Outcome of Dacryocystorhinostomy with Peroperative Local Use of Mitomycin-C

Authors: Chandra Shekhar Majumder, Orin Sultana Jamie

Abstract:

Background: Dacryocystorhinostomy (DCR) has been a widely accepted surgical intervention for nasolacrimal duct obstructions. Some previous studies demonstrated the potential benefits of the peroperative application of agents like Mitomycin-C (MMC) with DCR to improve surgical outcomes. Relevant studies are rare in Bangladesh, and there are controversies about the dose, duration of MMC, and outcome. Therefore, the present study aimed to investigate the comparative efficacy of DCR with and without MMC in a tertiary hospital in Bangladesh. Objective: The study aims to determine the outcome of a dacryocystorhinostomy with preoperative local use of mitomycin–C. Methods: An analytical study was conducted in the Department of Ophthalmology, Sir Salimullah Medical College & Mitford Hospital, Dhaka, from January 2023 to September 2023. Seventy patients who were admitted for DCR operation were included according to the inclusion and exclusion criteria. Patients were divided into two groups: those who underwent DCR with peroperative administration of 0.2 mg/ml Mitomycin-C for 5 minutes (Group I) and those who underwent DCR alone (Group II). All patients were subjected to detailed history taking, clinical examination, and relevant investigations. All patients underwent DCR according to standard guidelines and ensured the highest peroperative and postoperative care. Then, patients were followed up at 7th POD, 1-month POD, 3 months POD, and 6 months POD to observe the success rate between the two groups by assessing tearing condition, irrigation, height of tear meniscus, and FDDT- test. Data was recorded using a pre-structured questionnaire, and collected data were analyzed using SPSS 23. Results: The mean age of the study patients was 42.17±6.7 (SD) years and 42.29±7.1 (SD) years in Groups I and II, respectively, with no significant difference (p=0.945). At the 6th month’s follow-up, group I patients were observed with 94.3% frequency of symptom-free, 85.6% patency of lacrimal drainage system, 68.6% had tear meniscus <0.1mm and 88.6% had positive Fluorescence Dye Disappearance Test (FDDT test). In group II, 91.4% were symptom-free, 68.6% showed patency, 57.1% had a height of tear meniscus < 0.1 mm, and 85.6% had FDDT test positive. But no statistically significant difference was observed (p<.05). Conclusion: The use of Mitomycin-C preoperatively during DCR offers better postoperative outcomes, particularly in maintaining patency and achieving symptom resolution with more FDDT test positive and improvement of tear meniscus in the MMC group than the control group. However, this study didn’t demonstrate a statistically significant difference between the two groups. Further research with larger sample sizes and longer follow-up periods would be beneficial to corroborate these findings.

Keywords: dacryocystorhinostomy, mitomycin-c, dacryocystitis, nasolacrimal duct obstruction

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8731 The Improvement in Clinical Outcomes with the Histological Presence of Nidus Following Radiofrequency Ablation (RFA) for Osteoid Osteoma (OO)

Authors: Amirul Adlan, Motaz AlAqeel, Scott Evans, Vaiyapuri sumathi, Mark Davies, Rajesh Botchu

Abstract:

Background & Objectives: Osteoid osteoma (OO) is a benign tumor of the bone commonly found in childhood and adolescence, causing bone pain, especially during the night. CT-guided radiofrequency ablation (RFA) is currently the mainstay treatment for OO. There is currently no literature reporting the outcomes of OO following RFA based on the histological presence of a nidus seen on a biopsy taken at the time of RFA. The primary aim of this study was to compare the clinical outcomes of OO between the group of patients with the presence of nidus on biopsy samples from RFA with those without nidus. Secondly, we aimed to examine other factors that may affect the outcomes of OO, reflecting our experience as a tertiary orthopedic oncology center. Methods: We retrospectively reviewed 88 consecutive patients diagnosed with osteoid osteoma treated with RFA between November 2005 and March 2015, consisting of 63 males (72%) and 25 females (28%). Sixty-six patients (75%) had nidus present in their biopsy samples. Patients’ mean age was 17.6 years (4-53). The median duration of follow-up was 12.5 months (6-20.8). Lesions were located in the appendicular skeleton in seventy-nine patients (90%), while nine patients (10%) had an OO in the axial skeleton. Outcomes assessed were based on patients’ pain alleviation (partial, complete, or no pain improvement) and the need for further interventions. Results: Pain improvement in the patient group with nidus in the histology sample was significantly better than in the group without nidus (OR 7.4, CI 1.35-41.4, p=0.021). The patient group with nidus on biopsy demonstrated less likelihood of having a repeat procedure compared to the group without nidus(OR 0.092, CI 0.016-0.542, p=0.008). Our study showed significantly better outcomes in pain improvement in appendicular lesions compared to the axially located lesions (p = 0.005). Patients with spinal lesions tend to have relatively poor pain relief than those with appendicular or pelvic lesions (p=0.007). Conclusions: Patients with nidus on histology had better pain alleviation compared to patients without nidus. The histological presence of nidus significantly reduces the chance of repeat interventions. The pain alleviation of osteoid osteoma following RFA is better in patients with appendicular lesions than spinal or axially located lesions.

Keywords: osteoid osteoma, benign tumour, radiofrequency ablation, oncology

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8730 Labyrinthine Venous Vasculature Ablation for the Treatment of Sudden Sensorineural Hearing Loss: Two Case Reports

Authors: Kritin K. Verma, Bailey Duhon, Patrick W. Slater

Abstract:

Objective: To introduce the possible etiological role that the Labyrinthine Venous Vasculature (LVV) has in venous congestion of the cochlear system in Sudden Sensorineural Hearing Loss (SSNHL) patients. Patients: Two patients (62-year-old female, 50-year-old male) presented within twenty-four hours of onset of SSNHL. Intervention: Following failed conservative and salvage techniques, the patients underwent ablation of the labyrinthine venous vasculature ipsilateral to the side of the loss. Main Outcome Measures: Improvement of sudden SSNHL based on an improvement of pure-tone audiometric (PTA) low-tone scoring averages at 250, 500, and 1000 Hz. Word recognition scoring using the NU-6 word list was used to assess quality of life. Results: Case 1 experienced a 51.7 dB increase in low-tone PTA and an increased word recognition scoring of 90%. Case 2 experienced a 33.4 dB increase in low-tone PTA and 60% increase in word recognition score. No major complications noted. Conclusion: Two patients experienced significant improvement in their low-tone PTA and word recognition scoring following the labyrinthine venous vasculature ablation.

Keywords: case report, sudden sensorineural hearing loss, venous congestion, vascular ablation

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8729 The Design of a Phase I/II Trial of Neoadjuvant RT with Interdigitated Multiple Fractions of Lattice RT for Large High-grade Soft-Tissue Sarcoma

Authors: Georges F. Hatoum, Thomas H. Temple, Silvio Garcia, Xiaodong Wu

Abstract:

Soft Tissue Sarcomas (STS) represent a diverse group of malignancies with heterogeneous clinical and pathological features. The treatment of extremity STS aims to achieve optimal local tumor control, improved survival, and preservation of limb function. The National Comprehensive Cancer Network guidelines, based on the cumulated clinical data, recommend radiation therapy (RT) in conjunction with limb-sparing surgery for large, high-grade STS measuring greater than 5 cm in size. Such treatment strategy can offer a cure for patients. However, when recurrence occurs (in nearly half of patients), the prognosis is poor, with a median survival of 12 to 15 months and with only palliative treatment options available. The spatially-fractionated-radiotherapy (SFRT), with a long history of treating bulky tumors as a non-mainstream technique, has gained new attention in recent years due to its unconventional therapeutic effects, such as bystander/abscopal effects. Combining single fraction of GRID, the original form of SFRT, with conventional RT was shown to have marginally increased the rate of pathological necrosis, which has been recognized to have a positive correlation to overall survival. In an effort to consistently increase the pathological necrosis rate over 90%, multiple fractions of Lattice RT (LRT), a newer form of 3D SFRT, interdigitated with the standard RT as neoadjuvant therapy was conducted in a preliminary clinical setting. With favorable results of over 95% of necrosis rate in a small cohort of patients, a Phase I/II clinical study was proposed to exam the safety and feasibility of this new strategy. Herein the design of the clinical study is presented. In this single-arm, two-stage phase I/II clinical trial, the primary objectives are >80% of the patients achieving >90% tumor necrosis and to evaluation the toxicity; the secondary objectives are to evaluate the local control, disease free survival and overall survival (OS), as well as the correlation between clinical response and the relevant biomarkers. The study plans to accrue patients over a span of two years. All patient will be treated with the new neoadjuvant RT regimen, in which one of every five fractions of conventional RT is replaced by a LRT fraction with vertices receiving dose ≥10Gy while keeping the tumor periphery at or close to 2 Gy per fraction. Surgical removal of the tumor is planned to occur 6 to 8 weeks following the completion of radiation therapy. The study will employ a Pocock-style early stopping boundary to ensure patient safety. The patients will be followed and monitored for a period of five years. Despite much effort, the rarity of the disease has resulted in limited novel therapeutic breakthroughs. Although a higher rate of treatment-induced tumor necrosis has been associated with improved OS, with the current techniques, only 20% of patients with large, high-grade tumors achieve a tumor necrosis rate exceeding 50%. If this new neoadjuvant strategy is proven effective, an appreciable improvement in clinical outcome without added toxicity can be anticipated. Due to the rarity of the disease, it is hoped that such study could be orchestrated in a multi-institutional setting.

Keywords: lattice RT, necrosis, SFRT, soft tissue sarcoma

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8728 Social Justice-Focused Mental Health Practice: An Integrative Model for Clinical Social Work

Authors: Hye-Kyung Kang

Abstract:

Social justice is a central principle of the social work profession and education. However, scholars have long questioned the profession’s commitment to putting social justice values into practice. Clinical social work has been particularly criticized for its lack of attention to social justice and for failing to address the concerns of the oppressed. One prominent criticism of clinical social work is that it often relies on individual intervention and fails to take on system-level changes or advocacy. This concern evokes the historical macro-micro tension of the social work profession where micro (e.g., mental health counseling) and macro (e.g., policy advocacy) practices are conceptualized as separate domains, creating a false binary for social workers. One contributor to this false binary seems to be that most clinical practice models do not prepare social work students and practitioners to make a clear link between clinical practice and social justice. This paper presents a model of clinical social work practice that clearly recognizes the essential and necessary connection between social justice, advocacy, and clinical practice throughout the clinical process: engagement, assessment, intervention, and evaluation. Contemporary relational theories, critical social work frameworks, and anti-oppressive practice approaches are integrated to build a clinical social work practice model that addresses the urgent need for mental health practice that not only helps and heals the person but also challenges societal oppressions and aims to change them. The application of the model is presented through case vignettes.

Keywords: social justice, clinical social work, clinical social work model, integrative model

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