Search results for: clinical outcome

Authors: Sunila John, B. Rajashekhar

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Initial letter fluency tasks are one of the simple behavioral measures to evaluate the complex nature of word retrieval ability. This task requires the participant to retrieve as many words as possible beginning with a particular letter in a fixed time frame. Though the task of verbal fluency is popular among adult clinical conditions, its role in children has been less emphasized. There exists a lack of in-depth understanding of processes underlying verbal fluency performance in typically developing children. The present study, therefore, aims to delineate the developmental trend on initial letter fluency task observed in typically developing Malayalam speaking children. The participants were aged between 5 to 10 years and categorized into three groups: Group I (class I and II, mean (SD) age years: 6.44(.78)), Group II (class III and IV, mean (SD) age years: 8.59 (.83)) and group III (class V and VI, mean (SD) age years: 10.28 (.80). On two tasks of initial letter fluency, the verbal fluency outcome measures were analyzed. The study findings revealed a distinct pattern of initial letter fluency development which may enhance its usefulness in clinical and research settings.

Keywords: children, development, initial letter fluency, word retrieval

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Authors: Ana B. Vivas, Antonia Ypsilanti, Aristea I. Ladas, Angeles F. Estevez

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Mild Cognitive Impairment (MCI) is considered an intermediate stage between normal and pathological aging, as a substantial percentage of people diagnosed with MCI converts later to dementia of the Alzheimer’s type. Memory is of the first cognitive processes to deteriorate in this condition. In the present study we employed the differential outcomes procedure (DOP) to improve visuospatial memory in a group of participants with MCI. The DOP requires the structure of a conditional discriminative learning task in which a correct choice response to a specific stimulus-stimulus association is reinforced with a particular reinforcer or outcome. A group of 10 participants with MCI, and a matched control group had to learn and keep in working memory four target locations out of eight possible locations where a shape could be presented. Results showed that participants with MCI had a statistically significant better terminal accuracy when a unique outcome was paired with a location (76% accuracy) as compared to a non differential outcome condition (64%). This finding suggests that the DOP is useful in improving working memory in MCI patients, which may delay their conversion to dementia.

Keywords: mild cognitive impairment, working memory, differential outcomes, cognitive process

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Authors: Ramy Shaaban

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The purpose of this study was to examine the difference in clinical reasoning skills of students when using virtual audiology cases with and without collaborative assistance from major learning approaches important to clinical reasoning skills and computer-based learning models: Situated Learning Theory, Social Development Theory, Scaffolding, and Collaborative Learning. A quasi-experimental design was conducted at two United States universities to examine whether there is a significant difference in clinical reasoning skills between three treatment groups using IUP Audiosim software. Two computer-based audiology case simulations were developed, and participants were randomly placed into the three groups: no collaboration, virtual collaboration, and live collaboration. The clinical reasoning data were analyzed using One-Way ANOVA and Tukey posthoc analyses. The results show that there was a significant difference in clinical reasoning skills between the three treatment groups. The score obtained by the no collaboration group was significantly less than the scores obtained by the virtual and live collaboration groups. Collaboration, whether virtual or in person, has a positive effect on students’ clinical reasoning. These results with audiology students indicate that combining collaboration models with scaffolding and embedding situated learning and social development theories into the design of future virtual patients has the potential to improve students’ clinical reasoning skills.

Keywords: clinical reasoning, virtual patients, collaborative learning, scaffolding

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Authors: Sheeraz Memon, Namunu C. Maddage, Margaret Lech, Nicholas Allen

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The effect of a clinical environment on the accuracy of the speaker verification was tested. The speaker verification tests were performed within homogeneous environments containing clinically depressed speakers only, and non-depresses speakers only, as well as within mixed environments containing different mixtures of both climatically depressed and non-depressed speakers. The speaker verification framework included the MFCCs features and the GMM modeling and classification method. The speaker verification experiments within homogeneous environments showed 5.1% increase of the EER within the clinically depressed environment when compared to the non-depressed environment. It indicated that the clinical depression increases the intra-speaker variability and makes the speaker verification task more challenging. Experiments with mixed environments indicated that the increase of the percentage of the depressed individuals within a mixed environment increases the speaker verification equal error rates.

Keywords: speaker verification, GMM, EM, clinical environment, clinical depression

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Authors: Oliver Chunho Ma, Tszying Chang

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Background: Traditional Chinese Medicine (TCM) has been widely used in the treatment of eczema. However, there is currently a lack of comprehensive research on the overall effectiveness of TCM in treating eczema, particularly using the Eczema Area and Severity Index (EASI) score as an evaluation tool. Meta-analysis can integrate the results of multiple studies to provide more convincing evidence. Objective: To conduct a systematic review and meta-analysis based on the EASI score to evaluate the overall effectiveness of TCM in the treatment of eczema. Specifically, the study will review and analyze published clinical studies that investigate TCM treatments for eczema and use the EASI score as an outcome measure, comparing the differences in improving the severity of eczema between TCM and other treatment modalities, such as conventional Western medicine treatments. Methods: Relevant studies, including randomized controlled trials (RCTs) and non-randomized controlled trials, that involve TCM treatment for eczema and use the EASI score as an outcome measure will be searched in medical literature databases such as PubMed, CNKI, etc. Relevant data will be extracted from the selected studies, including study design, sample size, treatment methods, improvement in EASI score, etc. The methodological quality and risk of bias of the included studies will be assessed using appropriate evaluation tools (such as the Cochrane Handbook). The results of the selected studies will be statistically analyzed, including pooling effect sizes (such as standardized mean differences, relative risks, etc.), subgroup analysis (e.g., different TCM syndromes, different treatment modalities), and sensitivity analysis (e.g., excluding low-quality studies). Based on the results of the statistical analysis and quality assessment, the overall effectiveness of TCM in improving the severity of eczema will be interpreted. Expected outcomes: By integrating the results of multiple studies, we expect to provide more convincing evidence regarding the specific effects of TCM in improving the severity of eczema. Additionally, subgroup analysis and sensitivity analysis can further elucidate whether the effectiveness of TCM treatment is influenced by different factors. Besides, we will compare the results of the meta-analysis with the clinical data from our clinic. For both the clinical data and the meta-analysis results, we will perform descriptive statistics such as means, standard deviations, percentages, etc. and compare the differences between the two using statistical tests such as independent samples t-test or non-parametric tests to assess the statistical differences between them.

Keywords: Eczema, traditional Chinese medicine, EASI, systematic review, meta-analysis

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Authors: S. M. Satyam, K. L. Bairy, R. Pirasanthan, R. L. Vaishnav

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Zincovit tablets have been used as nutritional food supplement over a prolonged period of time. The aim of the present study was to investigate the cardio-protective effect of combined formulation of grape seed extract and Zincovit tablets (40, 80 and 160 mg/kg) using a Langendorff model of ischemia-reperfusion in Wistar rats. Following 21 days of pre-treatment, combined formulation of grape seed extract and Zincovit tablets significantly attenuated ischemia-reperfusion induced cardiac injury in terms of increased coronary flow rate (p < 0.01), decreased creatine kinase activity in coronary effluent (p < 0.05), decreased MDA (p < 0.001), 4-HNE (p < 0.001) and increased protein thiol content (p < 0.01) in comparison with the untreated (control) group. This study opens an avenue to clinical studies to demonstrate the validity of this paradigm as a nutritional food supplement, which could improve the clinical outcome of patients subjected to percutaneous angioplasty.

Keywords: grape seed extract, myocardial ischemia-reperfusion injury, oxidative stress, Zincovit tablets

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Authors: Luca Martignoni

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The increasing usage of clinical decision support systems in healthcare and the demand for software that enables doctors to take informed decisions is changing everyday clinical practice. However, as technology advances not only are the benefits of technology growing, but so are the potential risks. A growing danger is the doctors’ over-reliance on the proposed decision of the clinical decision support system, leading towards deskilling and rash decisions by doctors. In that regard, identifying doctors' requirements for software and developing approaches to prevent technological over-reliance is of utmost importance. In this paper, we report the results of a design science research study, focusing on the requirements and design principles of ultrasound software. We conducted a total of 15 interviews with experts about poten-tial ultrasound software functions. Subsequently, we developed meta-requirements and design principles to design future clinical decision support systems efficiently and as free from the occur-rence of technological over-reliance as possible.

Keywords: clinical decision support systems, technological over-reliance, design principles, design science research

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Authors: Chinelo Igwenagu

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Teenage childbearing in developing countries has been a thing of great concern as it has often led to a number of socioeconomic problems both to the society and to the families affected. The outcome of teenage pregnancy has been generally associated with higher rates of maternal morbidity and mortality, greater risks for delivery complications, low-birth weight infants and child mortality. As a result of teenagers’ physiological and social immaturity and their lack of adequate prenatal care, health risks associated with their pregnancies and childbearing are more pronounced than those of older women. Therefore this study has examined the relationship between the age of teenagers and the outcome of teenage pregnancy. Based on this study, the result of the analysis shows that both teenagers and older mothers suffer similarly during child bearing. Hence improve medical care is paramount in all the situations.

Keywords: childbearing, mortality, Nigeria, pregnancy, prematurity, teenagers

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Authors: Mamdouh Milad Adly Morkos

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Despite having the greatest rates of mortality and morbidity in the world, low- and middle-income (LMIC) nations trail high-income nations in terms of the number of clinical trials, the number of qualified researchers, and the amount of research information specific to their people. Health inequities and the use of precision medicine may be hampered by a lack of local genomic data, clinical pharmacology and pharmacometrics competence, and training opportunities. These issues can be solved by carrying out health care infrastructure development, which includes data gathering and well-designed clinical pharmacology training in LMICs. It will be advantageous if there is international cooperation focused at enhancing education and infrastructure and promoting locally motivated clinical trials and research. This paper outlines various instances where clinical pharmacology knowledge could be put to use, including pharmacogenomic opportunities that could lead to better clinical guideline recommendations. Examples of how clinical pharmacology training can be successfully implemented in LMICs are also provided, including clinical pharmacology and pharmacometrics training programmes in Africa and a Tanzanian researcher's personal experience while on a training sabbatical in the United States. These training initiatives will profit from advocacy for clinical pharmacologists' employment prospects and career development pathways, which are gradually becoming acknowledged and established in LMICs. The advancement of training and research infrastructure to increase clinical pharmacologists' knowledge in LMICs would be extremely beneficial because they have a significant role to play in global health

Keywords: electromagnetic solar system, nano-material, nano pharmacology, pharmacovigilance, quantum theoryclinical simulation, education, pharmacology, simulation, virtual learning low- and middle-income, clinical pharmacology, pharmacometrics, career development pathways

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Authors: Shih-Heng Sun, Hsiu-Yu Chang

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“Family centered service model” becomes mainstream in early intervention. Family outcome should be evaluated in addition child improvement in terms of outcome evaluation in early intervention. The purpose of this study is to develop a surveys to evaluate family outcomes in early intervention. Method: “Family Outcomes Survey- Revised Taiwan Version” (FOS-RT) was developed through translation, back-translation, and review by the original author. Expert meeting was held to determine the content validity. Two hundred and eighty six parent-child dyads recruited from 10 local Early Intervention Resource Centers (EIRC) participated in the study after they signed inform consent. The results showed both parts of FOS-RT exhibits good internal consistency and test-retest reliability. The result of confirmatory factor analysis indicated moderate fit of 5 factor structure of part A and 3 factor structure of part B of FOS-RT. The correlation between different sessions reached moderate to high level reveals some sessions measure similar latent trait of family outcomes. Correlation between FOS-RT and Parents‘ Perceived Parenting Skills Questionnaire was calculated to determine the convergence validity. The moderate correlation indicates the two assessments measure different parts of early intervention outcome although both assessments have similar sub-scales. The results of this study support FOS-RT is a valid and reliable tool to evaluate family outcome after the family and children with developmental disability receive early intervention services.

Keywords: early intervention, family service, outcome evaluation, parenting skills, family centered

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Authors: Tuong Thi Van Thuy, Dao Van Toan, Nguyen Duc Phuc

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Mesenchymal stem cells (MSCs) were discovered in the 1970s with their unique properties of differentiation, immunomodulation, multiple secreting, and homing factors to injured organs. MSC-based therapies have emerged as a promising strategy for various diseases such as cancer, tissue regeneration, or immunologic/inflammatory-related diseases. This study evaluated the clinical application of MSCs for cancer therapy in trials registered on Clinical Trial as of July 2022. The results showed 40 clinical trials used MSCs in various cancer conditions. 62% of trials used MSCs for therapeutic purposes to minimize the side effects of cancer treatment. Besides, 38% of trials were focused on using MSCs as a therapeutic agent to treat cancer directly. Most trials (38/40) are ongoing phase I/II, and 2 are entering phase III. 84% of trials used allogeneic MSCs compared with 13% using autologous sources and 3% using both. 25/40 trials showed participants received a single dose of MSCs, while the most times were 12 times in a pancreatic cancer treatment trial. Conclusion: MSC-based therapy for cancer in clinical trials should be applied to (1) minimize the side effects of oncological treatments and (2) directly affect the tumor via selectively delivering anti-cancer payloads to tumor cells. Allogeneic MSCs are a priority selected in clinical cancer therapy.

Keywords: mesenchymal stem cells, MSC-based therapy, cancer condition, cancer treatment, clinical trials

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Authors: Nautiyal Ruchira, Nautiyal Hemant, Chaudhury Devnanda, Bhargava Surbhi, Chauhan Nidhi

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Introduction: South East Asian region contributes 2.5 million cases of malaria each year to the global burden of 300 to 500 million of which 76% is reported from India. Government of India launched a national program almost half a century ago, still malaria remains a major public health challenge. Pregnant women are more susceptible to severe malaria and its fetomaternal complications. Inadequate surveillance and under-reporting underestimates the problem. Aim: Present study aimed to analyze the clinical course and pattern of malaria during pregnancy and to study the feto-maternal outcome. Methodology: This is a prospective observational study carried out at Himalayan Institute of Medical Sciences – a tertiary care center in the sub-Himalayan state of Uttarakhand, Northern India. All the pregnant women with malaria and its complications were recruited in the study during 2009 to 2014 which included referred cases from the state of western Uttar Pradesh. A thorough history and clinical examination were carried out to assess maternal and fetal condition. Relevant investigations including haemogram, platelet count, LFT, RFT, and USG was done. Blood slides and rapid diagnostic tests were done to diagnose the type of malaria.The primary outcomes measured were the type of malaria infection, maternal complications associated with malaria, outcome of pregnancy and effect on the fetus. Results: 67 antenatal cases with malaria infection were studied. 71% patients were diagnosed with plasmodium vivax infection, 25% cases were plasmodium falciparum positive and in 3% cases mixed infection was found. 38(56%) patients were primigravida and 29(43%) were multiparous. Most of the patients had already received some treatment from their local doctors and presented with severe malaria with the complications. Thrombocytopenia was the commonest manifestation seen in 35(52%) patients, jaundice in 28%, severe anemia in 18%, and severe oligohydramnios in 10% and renal failure in 6% cases. Regarding pregnancy outcome there were 44 % preterm deliveries, 22% had IUFD and abortions in 6% cases.20% of newborn were low birth weight and 6% were IUGR. There was only one maternal death which occurred due to ARDS in falciparum malaria. Although Plasmodium vivax was the main parasite considering the severity of clinical presentation, all the patients received intensive care. As most of the patients had received chloroquine therapy hence they were treated with IV artesunate followed by oral artemesinin combination therapy. Other therapies in the form of packed RBC’s and platelet transfusions, dialysis and ventilator support were provided when required. Conclusion: Even in areas with annual parasite index (API) less than 2 like ours, malaria in pregnancy could be an alarming problem. Vivax malaria cannot be considered benign in pregnancy because of high incidence of morbidity. Prompt diagnosis and aggressive treatment can reduce morbidity and mortality significantly. Increased community level research, integrating ANC checkups with the distribution of insecticide-treated nets in areas of high endemicity, imparting education and awareness will strengthen the existing control strategies.

Keywords: severe malaria, pregnancy, plasmodium vivax, plasmodium falciparum

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Authors: Antonia Harold-Barry, Eugene Dempsey

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Background: The objective is to examine the survival and outcome of infants born under 26 weeks gestation in an Irish tertiary maternity hospital from 2007-2016 and to describe the survival and neurodevelopmental outcomes of these extremely preterm infants. Method: The population is 132 infants born at 23, 24, and 25 weeks in Cork University Maternity Hospital from 2007 to 2016. Ethical approval was granted by the Cork Clinical Research Ethics Committee. Patient details were obtained from the Vermont Oxford and Badger Networks. Survival rates and Bayley scores were calculated to assess neurodevelopmental outcomes. Statistical analysis with SPSS included frequencies, distributions, and comparisons between data from 2007-2011 and 2012-2016. Results: Overall survival rate was 63%. Of the surviving babies, 61% had Bayley scores calculated. Survival stood at 39% for delivery at 23 weeks, 50% at 24 weeks, and 83% at 25 weeks. The 2012 to 2016 cohort has shown further increases in survival, with 50% of babies at 23 weeks, 58% at 24 weeks, and 89% at 25 weeks. Corresponding figures for 2007-2011 are 20%, 39%, and 75%. Gestational age and incidence of periventricular leukomalacia were statistically significant, with a p-value of 0.022. Gestational age and delivery room deaths had a p-value of 0.025, as did gestational age and birth weight. A comparison of the two cohorts (2007-2011 and 2012-2016) with the administration of antenatal steroids showed a statistically significant p-value of 0.044. Conclusion: There is less morbidity and mortality in infants born at 25 than at 23 or 24 weeks. Survival of extremely premature infants has increased significantly over the past ten years. Survival rates with normal neurodevelopmental outcomes are comparable with international standards and reflect positive changes in attitude and practices in neonatal intensive care. This study will inform parents about the potential outcomes of extreme prematurity and policy regarding the management of extreme prematurity.

Keywords: extreme of viability, neurodevelopmental outcome, periventricular leukomalacia, prematurity

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Authors: Alok Bapatla, Pamela Lutting, Mariastella Serrano

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Background: Irritable Bowel Syndrome (IBS) is a functional gastrointestinal disorder characterized by abdominal pain associated with altered bowel habits in the absence of an underlying organic cause. Although the exact etiology of IBS is not fully understood, one of the leading theories postulates a pathology within the Brain-Gut Axis that leads to an overall increase in gastrointestinal sensitivity and pejorative changes in gastrointestinal motility. Research and clinical practice have shown that Gut Directed Hypnotherapy (GDH) has a beneficial clinical role in improving Mind-Gut control and thereby comorbid conditions such as anxiety, abdominal pain, constipation, and diarrhea. Aims: This study presents a 17-year old male with underlying anxiety and a one-year history of IBS-Constipation Predominant Subtype (IBS-C), who has demonstrated impressive improvement of symptoms following GDH treatment following refractory trials with medications including bisacodyl, senna, docusate, magnesium citrate, lubiprostone, linaclotide. Method: The patient was referred to a licensed clinical psychologist specializing in clinical hypnosis and cognitive-behavioral therapy (CBT), who implemented “The Standardized Hypnosis Protocol for IBS” developed by Dr. Olafur S. Palsson, Psy.D at the University of North Carolina at Chapel Hill. The hypnotherapy protocol consisted of a total of seven weekly 45-minute sessions supplemented with a 20-minute audio recording to be listened to once daily. Outcome variables included the GAD-7, PHQ-9 and DCI-2, as well as self-ratings (ranging 0-10) for pain (intensity and frequency), emotional distress about IBS symptoms, and overall emotional distress. All variables were measured at intake prior to administration of the hypnosis protocol and at the conclusion of the hypnosis treatment. A retrospective IBS Questionnaire (IBS Severity Scoring System) was also completed at the conclusion of the GDH treatment for pre-and post-test ratings of clinical symptoms. Results: The patient showed improvement in all outcome variables and self-ratings, including abdominal pain intensity, frequency of abdominal pain episodes, emotional distress relating to gut issues, depression, and anxiety. The IBS Questionnaire showed a significant improvement from a severity score of 400 (defined as severe) prior to GDH intervention compared to 55 (defined as complete resolution) at four months after the last session. IBS Questionnaire subset questions that showed a significant score improvement included abdominal pain intensity, days of pain experienced per 10 days, satisfaction with bowel habits, and overall interference of life affected by IBS symptoms. Conclusion: This case supports the existing research literature that GDH has a significantly beneficial role in improving symptoms in patients with IBS. Emphasis is placed on the numerical results of the IBS Questionnaire scoring, which reflects a patient who initially suffered from severe IBS with failed response to multiple medications, who subsequently showed full and sustained resolution

Keywords: pediatrics, constipation, irritable bowel syndrome, hypnotherapy, gut-directed hypnosis

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Authors: Terentes Printzios Dimitrios, Loanna Gourgouli, Vlachopoulos Charalambos

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Aims: Atrial fibrillation (AF) remains one of the major causes of stroke, heart failure, sudden death and cardiovascular morbidity. Ablation techniques are becoming more appealing after the latest results of randomized trials showing the overall clinical benefit. On the other hand, imaging techniques and the frontier application of 3D printing are emerging as a valuable ally for cardiac procedures. However, no randomized trial has directly assessed the impact of preprocedural imaging and especially 3D printing guidance for AF ablation. The present study is designed to investigate for the first time the effect of 3D printing of the heart on the safety and effectiveness of the ablation procedure. Methods and design: The 3D-GALA trial is a randomized, open-label, controlled, multicentre clinical trial of 2 parallel groups designed to enroll a total of 100 patients undergoing ablation using cryo-balloon for paroxysmal and persistent AF. Patients will be randomized with a patient allocation ratio of 1: 1 to preprocedural MRI scan of the heart and 3D printing of left atrium and pulmonary veins and cryoablation versus standard cryoablation without imaging. Patients will be followed up to 6 months after the index procedure. The primary outcome measure is the reduction of radiation dose and contrast amount during pulmonary veins isolation. Secondary endpoints will include the percentage of atrial fibrillation relapse at 24h-Holter electrocardiogram monitoring at 6 months after initial treatment. Discussion: To our knowledge, the 3D-GALA trial will be the first study to provide evidence about the clinical impact of preprocedural imaging and 3D printing before cryoablation.

Keywords: atrial fibrillation, cardiac MRI, cryoablation, 3-d printing

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Authors: Chia-Yi Wu, Jung-Chen Chang, Wen-Yu Hu, Ming-Been Lee

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In nearly all physical health conditions, suicide risk is increased compared to healthy people even after adjustment for age, gender, mental health, and substance use diagnoses. In order to highlight the importance of suicide risk assessment for the inpatients and early identification and engagement for inpatients’ mental health problems, a study was designed aiming at developing a comprehensive psychosomatic nursing engagement (PSNE) model with standardized operation procedures informing how nurses communicate, assess, and engage with the inpatients with emotional distress. The purpose of the study was to promote the gatekeeping role of clinical nurses in performing brief assessment and interventions to detect depression and anxiety symptoms among the inpatients, particularly in non-psychiatric wards. The study will be carried out in a 2000-bed university hospital in Northern Taiwan in 2019. We will select a ward for trial and develop feasible procedures and in-job training course for the nurses to offer mental health care, which will also be validated through professional consensus meeting. The significance of the study includes the following three points: (1) The study targets at an important but less-researched area of PSNE model in the cultural background of Taiwan, where hospital service is highly accessible, but mental health and suicide risk assessment are hardly provided by non-psychiatric healthcare personnel. (2) The issue of PSNE could be efficient and cost-effective in the identification of suicide risks at an early stage to prevent inpatient suicide or to reduce future suicide risk by early treatment of mental illnesses among the high-risk group of hospitalized patients who are more than three-times lethal to suicide. (3) Utilizing a brief tool with its established APP ('The Five-item Brief Symptom Rating Scale, BSRS-5'), we will invent the standardized procedure of PSNE and referral steps in collaboration with the medical teams across the study hospital. New technological tools nested within nursing assessment/intervention will concurrently be invented to facilitate better care quality. The major outcome measurements will include tools for early identification of common mental distress and suicide risks, i.e., the BSRS-5, revised BSRS-5, and the 9-item Concise Mental Health Checklist (CMHC-9). The main purpose of using the CMHC-9 in clinical suicide risk assessment is mainly to provide care and build-up therapeutic relationship with the client, so it will also be used to nursing training highlighting the skills of supportive care. Through early identification of the inpatients’ depressive symptoms or other mental health care needs such as insomnia, anxiety, or suicide risk, the majority of the nursing clinicians would be able to engage in critical interventions that alleviate the inpatients’ suffering from mental health problems, given a feasible nursing input.

Keywords: mental health care, clinical outcome improvement, clinical nurses, suicide prevention, psychosomatic nursing

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Authors: Abiola Falilat Ibraheem, Akinyimika Sowunmi, Valerie Otti

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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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Authors: Tuula Heinonen, Wilhelm Gaus

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At present safety, assessment starts with animal tests although their predictivity is often poor. Even after extended human use experimental data are often judged as the core information for risk assessment. However, the best opportunity to generate true evidence is to match all available information. Cross matching methodology combines the different fields of knowledge and types of data (e.g. in-vitro and in-vivo experiments, clinical observations, clinical and epidemiological studies, and daily life observations) and gives adequate weight to individual findings. To achieve a consolidated outcome, the information from all available sources is analysed and compared with each other. If single pieces of information fit together a clear picture becomes visible. If pieces of information are inconsistent or contradictory careful consideration is necessary. 'Cross' can be understood as 'orthographic' in geometry or as 'independent' in mathematics. Results coming from different sources bring independent and; therefore, they result in new information. Independent information gives a larger contribution to evidence than results coming repeatedly from the same source. A successful example of cross matching is the assessment of Ginkgo biloba where we were able to come to the conclusive result: Ginkgo biloba leave extract is well tolerated and safe for humans.

Keywords: cross-matching, human use, safety assessment, Ginkgo biloba leave extract

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Authors: Liane J. Ioannou, Jonathan Serpell, Joanne Dean, Cino Bendinelli, Jenny Gough, Dean Lisewski, Julie Miller, Win Meyer-Rochow, Stan Sidhu, Duncan Topliss, David Walters, John Zalcberg, Susannah Ahern

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Background: The occurrence of thyroid cancer is increasing throughout the developed world, including Australia and New Zealand, and since the 1990s has become the fastest increasing malignancy. Following the success of a number of institutional databases that monitor outcomes after thyroid surgery, the Australian and New Zealand Endocrine Surgeons (ANZES) agreed to auspice the development of a bi-national thyroid cancer registry. Objectives: To establish a bi-national population-based clinical quality registry with the aim of monitoring and improving the quality of care provided to patients diagnosed with thyroid cancer in Australia and New Zealand. Patients and Methods: The Australian and New Zealand Thyroid Cancer Registry (ANZTCR) captures clinical data for all patients, over the age of 18 years, diagnosed with thyroid cancer, confirmed by histopathology report, that have been diagnosed, assessed or treated at a contributing hospital. Data is collected by endocrine surgeons using a web-based interface, REDCap, primarily via direct data entry. Results: A multi-disciplinary Steering Committee was formed, and with operational support from Monash University the ANZTCR was established in early 2017. The pilot phase of the registry is currently operating in Victoria, New South Wales, Queensland, Western Australia and South Australia, with over 30 sites expected to come on board across Australia and New Zealand in 2018. A modified-Delphi process was undertaken to determine the key quality indicators to be reported by the registry, and a minimum dataset was developed comprising information regarding thyroid cancer diagnosis, pathology, surgery, and 30-day follow up. Conclusion: There are very few established thyroid cancer registries internationally, yet clinical quality registries have shown valuable outcomes and patient benefits in other cancers. The establishment of the ANZTCR provides the opportunity for Australia and New Zealand to further understand the current practice in the treatment of thyroid cancer and reasons for variation in outcomes. The engagement of endocrine surgeons in supporting this initiative is crucial. While the pilot registry has a focus on early clinical outcomes, it is anticipated that future collection of longer-term outcome data particularly for patients with the poor prognostic disease will add significant further value to the registry.

Keywords: thyroid cancer, clinical registry, population health, quality improvement

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Authors: Jenny Jin

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Background: The therapeutic use of cannabis for cancer symptom control in Australia is gaining momentum, reflecting a broader global acceptance of its medicinal potential. Objective: This overview examines the historical context, current regulations, and clinical applications of cannabis in oncology within Australia. Methods: A historical analysis outlines the ancient and 19th-century medicinal uses of cannabis, followed by its prohibition in the early 20th century and subsequent resurgence in the late 20th century. The current legal framework under the therapeutic gods administration (TGA) is discussed. Results: Research indicates that cannabinoids, particularly THC and CBD, effectively alleviate pain, reduce chemotherapy-induced nausea and vomiting, stimulate appetite, and enhance overall quality of life for cancer patients. Despite these benefits, challenges such as dosing standardization, stigma, and access barriers persist. Conclusion: Continued clinical research, policy development, and educational initiatives are essential to optimize the use of cannabis in cancer care. A patient-centred approach, emphasizing interdisciplinary collaboration and informed decision-making, is crucial for improving therapeutic outcomes in this evolving field.

Keywords: historical context of cannabis, symptom control in oncology patients, therapeutic benefits, outcome and future

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Authors: Ghanem Al-Ghamdi

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African Horse Sickness causes significant challenges to horse practitioners and owners in Africa and possibly in certain locations in the Arab Pensila. The aim of this work was to observe a hot spot of epidemic in Al-Baha, Southwestern of Saudi Arabia that could be AHS. A five year-old horse farm that had eight horses with no history of clinical problems was visited in late October 2014. In August 2014, horses showed clinical signs of severe pain, congestion of mucus membranes, foam oozing of the nose, recumbency, difficult breath and ultimately death. The course of the disease averaged 2 days. The farm had no previous history of this episode. Other animals including camel, sheep reside the same farm sharing feeding and water sources however no obvious similar clinical problems were noticed among the two species. Five horses showed the clinical disease and all horses were lost. Veterinary help was not available for diagnosis or treatment. A follow up visit to the farm after one year indicated that the three remaining horses were healthy but were relocated to a different facility out the Al-Baha Region. The most likely cause of such clinical problem is African Horse Sickness, however clinical exam and sampling of other horses in the region is absolute must as well as examining arthropods.

Keywords: African horse sickness, horses, Al-Baha, Saudi Arabia

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Authors: M. Dakshayini, P. Jayarekha

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In traditional output-based education system, class room lecture and laboratory are the traditional delivery methods used during the course. Written examination and lab examination have been used as a conventional tool for evaluating student’s performance. Hence, there are certain apprehensions that the traditional education system may not efficiently prepare the students for competent professional life. This has led for the change from Traditional output-based education to Outcome-Based Education (OBE). OBE first sets the ideal programme learning outcome consecutively on increasing degree of complexity that students are expected to master. The core curriculum, teaching methodologies and assessment tools are then designed to achieve the proposed outcomes mainly focusing on what students can actually attain after they are taught. In this paper, we discuss a promising applications based learning and evaluation component involving industry collaboration to improve the quality of teaching and student learning process. Incorporation of this component definitely improves the quality of student learning in engineering education and helps the student to attain the competency as per the graduate attributes. This may also reduce the Industry-academia gap.

Keywords: outcome-based education, programme learning outcome, teaching-learning process, evaluation, industry collaboration

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Authors: Valerie A. Conrade

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Introduction: A large body of literature suggests patients who complete fecal immunochemical testing (FIT) kits are likely to identify colorectal cancer sooner than those who do not complete FIT kits. Background: Patients who do not participate in preventative measures such as the FIT kit are at a higher risk of colorectal cancer growing unnoticed. The objective was to see if the method the principal investigator (PI) uses to educate clinical staff on the importance of FIT kit administration provides an increased amount of FIT kit dissemination to patients post clinical education. Methodologies: Data collection via manual tallies took place before and after the clinical staff was educated on the importance of FIT kits. Results: The results showed an increase in FIT kit dissemination post clinical staff education. Through enhanced instruction to the clinical staff regarding the importance of FIT kits, expanding their knowledge on preventative measures to detect colorectal cancer positively impacted nurses and, in turn, their patients.

Keywords: colon cancer, education, fecal immunochemical testing, nursing

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Authors: Hassan Karimi, Fred Piercy, Ruoxi Chen, Ana L. Jaramillo-Sierra, Wei-Ning Chang, Manjushree Palit, Catherine Martosudarmo, Angelito Antonio

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Background: The two psychotherapy camps, the randomized clinical trials (RCTs) and the common factors model, have competitively claimed specific explanations for therapy effectiveness. Recently, scholars called for empirical evidence to show the role of common factors in therapeutic outcome in marriage and family therapy. Purpose: This cross-national study aims to explore how clinicians, across different nations and theoretical orientations, attribute the contribution of common factors to therapy outcome. Method: A brief common factors questionnaire (CFQ-with a Cronbach’s Alpha, 0.77) was developed and administered in seven nations. A series of statistical analyses (paired-samples t-test, independent sample t-test, ANOVA) were conducted: to compare clinicians perceived contribution of total common factors versus model-specific factors, to compare each pair of common factors’ categories, and to compare clinicians from collectivistic nations versus clinicians from individualistic nation. Results: Clinicians across seven nations attributed 86% to common factors versus 14% to model-specific factors. Clinicians attributed 34% of therapeutic change to client’s factors, 26% to therapist’s factors, 26% to relationship factors, and 14% to model-specific techniques. The ANOVA test indicated each of the three categories of common factors (client 34%, therapist 26%, relationship 26%) showed higher contribution in therapeutic outcome than the category of model specific factors (techniques 14%). Clinicians with psychology degree attributed more contribution to model-specific factors than clinicians with MFT and counseling degrees who attributed more contribution to client factors. Clinicians from collectivistic nations attributed larger contributions to therapist’s factors (M=28.96, SD=12.75) than the US clinicians (M=23.22, SD=7.73). The US clinicians attributed a larger contribution to client’s factors (M=39.02, SD=1504) than clinicians from the collectivistic nations (M=28.71, SD=15.74). Conclusion: The findings indicate clinicians across the globe attributed more than two thirds of therapeutic change to CFs, which emphasize the training of the common factors model in the field. CFs, like model-specific factors, vary in their contribution to therapy outcome in relation to specific client, therapist, problem, treatment model, and sociocultural context. Sociocultural expectations and norms should be considered as a context in which both CFs and model-specific factors function toward therapeutic goals. Clinicians need to foster a cultural competency specifically regarding the divergent ways that CFs can be activated due to specific sociocultural values.

Keywords: common factors, model-specific factors, cross-national survey, therapist cultural competency, enhancing therapist efficacy

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Authors: Eric Lee G. Escobedo-Wu, Nidhi Rohatgi, Fouzel Dhebar

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It is challenging for patients to navigate through healthcare systems after-hours. This leads to delays in care, patient/provider dissatisfaction, inappropriate resource utilization, readmissions, and higher costs. It is important to provide patients and providers with effective clinical decision-making tools to allow seamless connectivity and coordinated care. In August 2015, patient-centric Stanford Health Care established Clinical Advice Services (CAS) to provide clinical decision support after-hours. CAS is founded on key Lean principles: Value stream mapping, empathy mapping, waste walk, takt time calculations, standard work, plan-do-check-act cycles, and active daily management. At CAS, Clinical Assistants take the initial call and manage all non-clinical calls (e.g., appointments, directions, general information). If the patient has a clinical symptom, the CAS nurses take the call and utilize standardized clinical algorithms to triage the patient to home, clinic, urgent care, emergency department, or 911. Nurses may also contact the on-call physician based on the clinical algorithm for further direction and consultation. Since August 2015, CAS has managed 228,990 calls from 26 clinical specialties. Reporting is built into the electronic health record for analysis and data collection. 65.3% of the after-hours calls are clinically related. Average clinical algorithm adherence rate has been 92%. An average of 9% of calls was escalated by CAS nurses to the physician on call. An average of 5% of patients was triaged to the Emergency Department by CAS. Key learnings indicate that a seamless connectivity vision, cascading, multidisciplinary ownership of the problem, and synergistic enterprise improvements have contributed to this success while striving for continuous improvement.

Keywords: after hours phone calls, clinical advice services, nurse triage, Stanford Health Care

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Authors: Animesh Gupta

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Objective: The purpose of this study is to evaluate the versatility and outcome of lateral supra malleolar flap (LSMF) in soft tissue reconstruction of the regions including the distal leg, ankle, dorsal foot and heel. Methods: From March 2021 to April 2023, 18 patients with soft tissue defects in the regions, including the distal leg, ankle, dorsal foot and heel, who underwent LSMF repair for lower limb wound reconstruction were analyzed. The location, size of the defects, etiology, outcome, complications, and other alternative options were studied and presented. Results: The follow-up period of the cases was 3-6 months after surgery. All flaps were successful; however, one flap was complicated by venous congestion and was managed by loosening a few sutures and the patient was required to elevate the affected limb to resolve the issue. Conclusion: The LSMF has numerous advantages in repairing soft tissue defects in areas involving the ankle, distal leg, heel and dorsum of the foot. In comparison to reverse sural flaps for repairing defects in the heel and lower leg, LSMF offers shorter operation time, shorter hospitalization, lower cost, and fewer postoperative complications.

Keywords: lateral supra malleolar flap, LSMF, soft tissue reconstruction, lower leg defect

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Authors: Afolabi O.J, Simon-Oke I.A., Oniya M.O., Okaka C.E.

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River blindness is a skin, and an eye disease caused by Onchocerca volvulus and vectored by a female hematophagous blackfly. The study aims to evaluate the distribution of the clinical signs of river blindness and the efficacy of ivermectin in the treatment of river blindness in Idogun. Observational studies in epidemiology that involve the use of a structured questionnaire to obtain useful epidemiological information from the respondents, physical assessment via palpation from head to ankle was used to assess clinical signs from the respondents and skin snip test was used to evaluate the prevalence of the disease. The efficacy of the drug was evaluated and expressed in percentages. One hundred and ninety-two (192) out of the 384 respondents examined, showed various signs of river blindness. However, it was only 108 (28.1%) respondents with the clinical signs that demonstrated Onchocerca volvulus microfilariae in their skin snips. The clinical signs observed among the respondents include skin depigmentation such as dermatitis, leopard skin, papules, pruritus and self-inflicted injury, while ocular symptoms include cataract, ocular lesion and partial blindness. Among these clinical signs, papules, and pruritus were the most dominant in the community. The prevalence of the clinical signs was observed to vary significantly among the age groups and gender (P<0.05). The efficacy of the drug after 6 and 12 months of treatments shows that the drug is more effective at age groups 10-50 years than the age groups 51-90 years. Ivermectin is observed to be efficacious in the treatment of the disease. However, to achieve eradication of the disease, the drug may be administered at 0.15mg/kg twice a year.

Keywords: riverblindness, clinical signs, ivermectin, Idogun

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Authors: Oktavian Prasetia Wardana, Martono Tri Utomo, Risa Etika, Kartika Darma Handayani, Dina Angelika, Wurry Ayuningtyas

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Background: Critically ill neonates are newborn babies with high-risk factors that potentially cause disability and/or death. Scoring systems for determining the severity of the disease have been widely developed as well as some designs for use in neonates. The SNAPPE-II method, which has been used as a mortality predictor scoring system in several referral centers, was found to be slow in assessing the outcome of critically ill neonates in the Neonatal Intensive Care Unit (NICU). Objective: To analyze the predictive value of MSNS on the outcome of critically ill neonates at the time of arrival up to 24 hours after being admitted to the NICU. Methods: A longitudinal observational analytic study based on medical record data was conducted from January to August 2022. Each sample was recorded from medical record data, including data on gestational age, mode of delivery, APGAR score at birth, resuscitation measures at birth, duration of resuscitation, post-resuscitation ventilation, physical examination at birth (including vital signs and any congenital abnormalities), the results of routine laboratory examinations, as well as the neonatal outcomes. Results: This study involved 105 critically ill neonates who were admitted to the NICU. The outcome of critically ill neonates was 50 (47.6%) neonates died, and 55 (52.4%) neonates lived. There were more males than females (61% vs. 39%). The mean gestational age of the subjects in this study was 33.8 ± 4.28 weeks, with the mean birth weight of the subjects being 1820.31 ± 33.18 g. The mean MSNS score of neonates with a deadly outcome was lower than that of the lived outcome. ROC curve with a cut point MSNS score <10.5 obtained an AUC of 93.5% (95% CI: 88.3-98.6) with a sensitivity value of 84% (95% CI: 80.5-94.9), specificity 80 % (CI 95%: 88.3-98.6), Positive Predictive Value (PPV) 79.2%, Negative Predictive Value (NPV) 84.6%, Risk Ratio (RR) 5.14 with Hosmer & Lemeshow test results p>0.05. Conclusion: The MSNS score has a good predictive value and good calibration of the outcomes of critically ill neonates admitted to the NICU.

Keywords: critically ill neonate, outcome, MSNS, NICU, predictive value

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Authors: Jeena R. S., Sukesh Kumar A.

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Stroke is one of the major reasons of adult disability and morbidity in many of the developing countries like India. Early diagnosis of stroke is essential for timely prevention and cure. Various conventional statistical methods and computational intelligent models have been developed for predicting the risk and outcome of stroke. This research work focuses on a multilevel approach for predicting the occurrence of stroke based on various risk factors and invasive techniques like retinal imaging. This risk prediction model can aid in clinical decision making and help patients to have an improved and reliable risk prediction.

Keywords: prediction, retinal imaging, risk factors, stroke

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Authors: Awais Ali, Hesham Ali

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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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