Search results for: clinical guidelines

Authors: Junaid Mahmood Alam

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Revalidating and harmonizing clinical chemistry analytical principles and optimizing methods through quality control programs and assessments is the preeminent means to attain optimal outcome within the clinical laboratory services. Present study reports revalidation of our existing IFCC regularized analytical methods, particularly hepatic and thyroid function tests, by optimization of precision analyses and processing through external and internal quality assessments and regression determination. Parametric components of hepatic (Bilirubin ALT, γGT, ALP), cardiac (LDH, AST, Trop I) and thyroid/pituitary (T3, T4, TSH, FT3, FT4) function tests were used to validate analytical techniques on automated chemistry and immunological analyzers namely Hitachi 912, Cobas 6000 e601, Cobas c501, Cobas e411 with UV kinetic, colorimetric dry chemistry principles and Electro-Chemiluminescence immunoassay (ECLi) techniques. Process of validation and revalidation was completed with evaluating and assessing the precision analyzed Preci-control data of various instruments plotting against each other with regression analyses R2. Results showed that: Revalidation and optimization of respective parameters that were accredited through CAP, CLSI and NEQAPP assessments depicted 99.0% to 99.8% optimization, in addition to the methodology and instruments used for analyses. Regression R2 analysis of BilT was 0.996, whereas that of ALT, ALP, γGT, LDH, AST, Trop I, T3, T4, TSH, FT3, and FT4 exhibited R2 0.998, 0.997, 0.993, 0.967, 0.970, 0.980, 0.976, 0.996, 0.997, 0.997, and R2 0.990, respectively. This confirmed marked harmonization of analytical methods and instrumentations thus revalidating optimized precision standardization as per IFCC recommended guidelines. It is concluded that practices of revalidating and harmonizing the existing or any new services should be followed by all clinical laboratories, especially those associated with tertiary care hospital. This is will ensure deliverance of standardized, proficiency tested, optimized services for prompt and better patient care that will guarantee maximum patients’ confidence.

Keywords: revalidation, standardized, IFCC, CAP, harmonized

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Authors: David Pettitt, Benjamin Davies, Georg Holländer, David Brindley

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Cellular based therapies, whose origins can be traced from the intertwined concepts of tissue engineering and regenerative medicine, have the potential to transform the current medical landscape and offer an approach to managing what were once considered untreatable diseases. However, despite a large increase in basic science activity in the cell therapy arena alongside a growing portfolio of cell therapy trials, the number of industry products available for widespread clinical use correlates poorly with such a magnitude of activity, with the number of cell-based therapeutics in mainstream use remaining comparatively low. This research serves to quantitatively assess the barriers to the clinical adoption of cell-based therapeutics through identification of unique barriers, specific challenges and opportunities facing the development and adoption of such therapies.

Keywords: cell therapy, clinical adoption, commercialization, translation

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Authors: Sau Kam Adeline Chan

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World Health Organization had listed ‘Communication during Patient Care Handovers’ as one of its highest 5 patient safety initiatives. Clinical handover means transfer of accountability and responsibility of clinical information from one health professional to another. The main goal of clinical handover is to convey patient’s current condition and treatment plan accurately. Ineffective communication at point of care is globally regarded as the main cause of the sentinel event. Situation, Background, Assessment and Recommendation (SBAR), a communication tool, is extensively regarded as an effective communication tool in healthcare setting. Nonetheless, just by scenario-based program in nursing school or attending workshops on SBAR would not be enough for freshly graduated nurses to apply it competently in a complex clinical practice. To what extend and in-depth of information should be conveyed during handover process is not easy to learn. As such, on-site coaching is essential to upgrade their expertise on the usage of SBAR and ultimately to avoid any clinical error. On-site coaching for all freshly graduated nurses on the usage of SBAR in clinical handover was commenced in August 2014. During the preceptorship period, freshly graduated nurses were coached by the preceptor. After that, they were gradually assigned to take care of a group of patients independently. Nurse leaders would join in their shift handover process at patient’s bedside. Feedback and support were given to them accordingly. Discrepancies on their clinical handover process were shared with them and documented for further improvement work. Owing to the constraint of manpower in nurse leader, about coaching for 30 times were provided to a nurse in a year. Staff satisfaction survey was conducted to gauge their feelings about the coaching and look into areas for further improvement. Number of clinical error avoided was documented as well. The nurses reported that there was a significant improvement particularly in their confidence and knowledge in clinical handover process. In addition, the sense of empowerment was developed when liaising with senior and experienced nurses. Their proficiency in applying SBAR was enhanced and they become more alert to the critical criteria of an effective clinical handover. Most importantly, accuracy of transferring patient’s condition was improved and repetition of information was avoided. Clinical errors were prevented and quality patient care was ensured. Using SBAR as a communication tool looks simple. The tool only provides a framework to guide the handover process. Nevertheless, without on-site training, loophole on clinical handover still exists, patient’s safety will be affected and clinical error still happens.

Keywords: freshly graduated nurse, competency of clinical handover, quality, clinical error

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Authors: Samad Lotfollahzadeh

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Escherichia coli (E.coli) is the most isolated bacteria from blood circulation of septicemic calves. Given the prevalence of septicemia in animals and its economic importance in veterinary practice, better understanding of changes in clinical signs following disease, may contribute to early detection of the disorder. The present study has been carried out to detect changes of clinical signs in induced sepsis in calves with E.coli. Colisepticemia has been induced in 10 twenty-day old healthy Holstein- Frisian calves with intravenous injection of 1.5 X 109 colony forming units (cfu) of O111: H8 strain of E.coli. Clinical signs including rectal temperature, heart rate, respiratory rate, shock, appetite, sucking reflex, feces consistency, general behavior, dehydration and standing ability were recorded in experimental calves during 24 hours after induction of colisepticemia. Blood culture was also carried out from calves four times during the experiment. ANOVA with repeated measure is used to see changes of calves’ clinical signs to experimental colisepticemia, and values of P≤ 0.05 was considered statistically significant. Mean values of rectal temperature and heart rate as well as median values of respiratory rate, appetite, suckling reflex, standing ability and feces consistency of experimental calves increased significantly during the study (P<0.05). In the present study, median value of shock score was not significantly increased in experimental calves (P> 0.05). The results of present study showed that total score of clinical signs in calves with experimental colisepticemia increased significantly, although the score of some clinical signs such as shock did not change significantly.

Keywords: calves, clinical signs scoring, E. coli O111:H8, experimental colisepticemia

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Authors: Hui-Yi Wang, Shu-Mei Chen, Mei-Fang Liu

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Background and purpose: Providing clinical experience in medical education is an important discipline method where students can gradually apply their academic knowledge to clinical situations. The purpose of this study was to establish self-assessment questionnaires for students to assess their learning outcomes for two fields of physical therapy, orthopedic physical therapy, and pediatric physical therapy, in a clinical fieldwork course. Methods: The questionnaires were developed based on the core competence dimensions of the course. The content validity of the questionnaires was evaluated and established by expert meetings. Among the third-year undergraduate students who took the clinical fieldwork course, there were 49 students participated in this study. Teachers arranged for the students to study two professional fields, and each professional field conducted a three-week clinical lesson. The students filled out the self-assessment questionnaires before and after each three-week lesson. Results: The self-assessment questionnaires were established by expert meetings that there were six core competency dimensions in each of the two fields, with 20 and 21 item-questions, respectively. After each three-week clinical fieldwork, the self-rating scores in each core competency dimension were higher when compared to those before the course, indicating having better clinical abilities after the lessons. The best self-rating scores were the dimension of attitude and humanistic literacy, and the two lower scores were the dimensions of professional knowledge and skills and problem-solving critical thinking. Conclusions: This study developed questionnaires for clinical fieldwork courses to reflect students' learning outcomes, including the performance of professional knowledge, practice skills, and professional attitudes. The use of self-assessment of learning performance can help students build up their reflective competencies. Teachers can guide students to pay attention to the performance of abilities in each core dimension to enhance the effectiveness of learning through self-reflection and improvement.

Keywords: physical therapy, clinical fieldwork course, learning outcomes assessment, medical education, self-reflection ability

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Authors: Carolyn J. Ortega, Stephen E. Berger

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The role of the custody evaluator is perhaps one of the most controversial and risky endeavors in clinical practice. Complaints filed with licensing boards regarding a child-custody evaluation constitute the second most common reason for such an event. Although the evaluator is expected to answer for the family-law court what is in the “best interest of the child,” there is a lack of clarity on how to establish this in any empirically validated manner. Hence, practitioners must contend with a nebulous framework in formulating their methodological procedures that inherently places them at risk in an already litigious context. This study sought to qualitatively investigate patterns of practice among doctoral practitioners conducting child custody evaluations in the area of Southern California. Ten psychologists were interviewed who devoted between 25 and 100% of their California private practice to custody work. All held Ph.D. degrees with a range of eight to 36 years of experience in custody work. Semi-structured interviews were used to investigate assessment practices, ensure adherence to guidelines, risk management, and qualities of evaluators. Forty-three Specific Themes were identified using Interpretive Phenomenological Analysis (IPA). Seven Higher Order Themes clustered on salient factors such as use of Ethics, Law, Guidelines; Parent Variables; Child Variables; Psychologist Variables; Testing; Literature; and Trends. Evaluators were aware of the ever-present reality of a licensure complaint and thus presented idiosyncratic descriptions of risk management considerations. Ambiguity about quantifying and validly tapping parenting abilities was also reviewed. Findings from this study suggested a high reliance on unstructured and observational methods in child custody practices.

Keywords: forensic psychology, psychological testing, assessment methodology, child custody

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Authors: Vandita Mishra

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From the management of patients, reception, record, and assistants in a clinical practice; to the management of ongoing research, clinical cases and department profile in an academic setup, the healthcare provider has to deal with all of it. The victory lies in smooth running of the show in both the above situations with an apt solution of problems encountered and smooth management of crisis faced. Thus this paper amalgamates dental science with health administration by means of introduction of a concept for practice management and problem-solving called 'Quality Circles'. This concept uses various tools for problem solving given by experts from different fields. QC tools can be applied in both clinical and academic settings in dentistry for better productivity and for scientifically approaching the process of continuous improvement in both the categories. When approached through QC, our organization showed better patient outcomes and more patient satisfaction. Introduced in 1962 by Kaoru Ishikawa, this tool has been extensively applied in certain fields outside dentistry and healthcare. By exemplification of some clinical cases and virtual scenarios, the tools of Quality circles will be elaborated and discussed upon.

Keywords: academics, dentistry, healthcare, quality

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Authors: Ingrid Van Der Heijden, Naeemah Abrahams, Jane Harries

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Background: Women with disabilities are largely missing from global research on violence prevention, yet research shows that women with disabilities are a particularly marginalised group who experience heightened levels and unique forms of violence than men with disabilities, and women without disabilities. They face heightened stigma, discrimination, and violence due to their gender and their disability. Including women with disabilities in violence, research helps inform policy and prevention interventions that are relevant and inclusive. To ensure their inclusion in violence research, we need ethical guidelines that are sensitive to their heightened risk and vulnerability, that recognize the diversity in the disabled population, but that also promote disabled people’s agency in defining their own violence prevention needs and agendas. Objective: To highlight pertinent ethical issues around women with disabilities’ inclusion and participation in violence research. Methodology: Considering the lack of formalized guidelines for research of people with disabilities, we draw from the literature on international ethics guidelines for researching violence against women, and the Emancipatory Disability Research paradigm, as well as drawing from our own experiences from the field in applying the guidelines when doing research with disabled women. Findings: Following the guiding ethical principles of respect, benefit, justice, and do no harm, we argue that reasonable accommodation, capacity, and equal participation need to be considered in conceptualizing and conducting ethical violence research with women with disabilities. We conclude that disability research in the area of violence is highly politicized and must be carefully scrutinized to ensure justice and the contribution of women with disabilities to their own welfare. Implications: We suggest that these issues are practically applied in the field and tested and critiqued to enhance best practice for undertaking ethical research with this particular group. It is important that not only researchers and ethics committees, but also disabled women and disabled organizations, are involved in enhancing and formalizing ethical research guidelines for marginalized populations.

Keywords: capacity, emancipatory disability research paradigm equal participation, reasonable accommodation, research ethics, violence against women with disabilities

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Authors: Awole Seid, Yosef Zenebe, Hadgu Gerensea, Kebede Haile Misgina

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Background: Clinical competence is one of the ultimate goals of nursing education. Clinical skills are more than successfully performing tasks; it incorporates client assessment, identification of deficits and the ability to critically think to provide solutions. Assessment of clinical competence, particularly identifying gaps that need improvement and determining the educational needs of nursing students have great importance in nursing education. Thus this study aims determining clinical self-efficacy of final year school of nursing students in three universities of Tigray Region. Methods: A cross-sectional study was conducted on 224 final year school of nursing students from department of nursing, psychiatric nursing, and midwifery on three universities of Tigray region. Anonymous self-administered questionnaire was administered to generate data collected on June, 2017. The data were analyzed using SPSS version 20. The result is described using tables and charts as required. Logistic regression was employed to test associations. Result: The mean age of students was 22.94 + 1.44. Generally, 21% of students have been graduated in the department in which they are not interested. The study demonstrated 28.6% had poor and 71.4% had good perceived clinical self-efficacy. Beside this, 43.8% of psychiatric nursing and 32.6% of comprehensive nursing students have poor clinical self-efficacy. Among the four domains, 39.3% and 37.9% have poor clinical self- efficacy with regard to ‘Professional development’ and ‘Management of care’. Place of the institution [AOR=3.480 (1.333 - 9.088), p=0.011], interest during department selection [AOR=2.202 (1.045 - 4.642), p=.038], and theory-practice gap [AOR=0.224 (0.110 - 0.457), p=0.000] were significantly associated with perceived clinical self-efficacy. Conclusion: The magnitude of students with poor clinically self efficacy was high. Place of institution, theory-practice gap, students interest to the discipline were the significant predictors of clinical self-efficacy. Students from youngest universities have good clinical self-efficacy. During department selection, student’s interest should be respected. The universities and other stakeholders should improve the capacity of surrounding affiliate teaching hospitals to set and improve care standards in order to narrow the theory-practice gap. School faculties should provide trainings to hospital staffs and monitor standards of clinical procedures.

Keywords: clinical self-efficacy, nursing students, Tigray, northern Ethiopia

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Authors: Clement Chimezie Aladi, Itamar Shabtai

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A review of the literature in the last few years reveals that little attention has been paid to technological affordances in e-learning designs. However, affordances are key to engaging students and enabling teachers to actualize learning goals. E-learning systems (software and artifacts) need to be designed in such a way that the features facilitate perceptions of the affordances with minimal cognition. This study aimed to fill this gap in the literature and encourage further research in this area. It provides guidelines for facilitating the perception of affordances in e-learning design and advances Technology Affordance and Constraints Theory by incorporating the affordance-based design process, the principles of multimedia learning, e-learning design philosophy, and emotional and cognitive affordances.

Keywords: e-learning, technology affrodances, affordance based design, e-learning design

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Authors: Ibraheem Husain, Abul Kalam Najmi, Karishma Chester

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First-in-human (FIH) studies are a critical step in clinical development of any molecule that has shown therapeutic promise in preclinical evaluations, since preclinical research and safety studies into clinical development is a crucial step for successful development of monoclonal antibodies for guidance in pharmaceutical industry for the treatment of human diseases. Therefore, comparison between USFDA and nine pharmacologically guided approaches (PGA) (simple allometry, maximum life span potential, brain weight, rule of exponent (ROE), two species methods and one species methods) were made to determine maximum recommended starting dose (MRSD) for first in human clinical trials using four drugs namely Denosumab, Bevacizumab, Anakinra and Omalizumab. In our study, the predicted pharmacokinetic (pk) parameters and the estimated first-in-human dose of antibodies were compared with the observed human values. The study indicated that the clearance and volume of distribution of antibodies can be predicted with reasonable accuracy in human and a good estimate of first human dose can be obtained from the predicted human clearance and volume of distribution. A pictorial method evaluation chart was also developed based on fold errors for simultaneous evaluation of various methods.

Keywords: clinical pharmacology (CPH), clinical research (CRE), clinical trials (CTR), maximum recommended starting dose (MRSD), clearance and volume of distribution

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Authors: Ji-Chan Jang

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Tuberculosis is still major health problem because there is an increase of multidrug-resistant and extensively drug-resistant forms of the disease. Therefore, the most urgent clinical need is to discover potent agents and develop novel drug combination capable of reducing the duration of MDR and XDR tuberculosis therapy. Three reference strains H37Rv, CDC1551, W-Beijing GC1237 and six clinical isolates of MDRTB were tested to daptomycin in the range of 0.013 to 256 mg/L. Daptomycin is resistant to all tested M. tuberculosis strains not only laboratory strains but also clinical MDR strains that were isolated at different source. Daptomycin will not be an antibiotic of choice for treating infection of Gram positive atypical slowly growing M. tuberculosis.

Keywords: tuberculosis, daptomycin, resistance, Mycobacterium tuberculosis

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Authors: Rajesh Kumar G

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A challenging aspect of any clinical trial is to carefully plan the study design to meet the study objective in optimum way and to validate the assumptions made during protocol designing. And when it is a pediatric study, there is the added challenge of stringent guidelines and difficulty in recruiting the necessary subjects. Unlike adult trials, there is not much historical data available for pediatrics, which is required to validate assumptions for planning pediatric trials. Typically, pediatric studies are initiated as soon as approval is obtained for a drug to be marketed for adults, so with the adult study historical information and with the available pediatric pilot study data or simulated pediatric data, the pediatric study can be well planned. Generalizing the historical adult study for new pediatric study is a tedious task; however, it is possible by integrating various statistical techniques and utilizing the advantage of hybrid study design, which will help to achieve the study objective in a smoother way even with the presence of many constraints. This research paper will explain how well the hybrid study design can be planned along with integrated technique (SEV) to plan the pediatric study; In brief the SEV technique (Simulation, Estimation (using borrowed adult data and applying Bayesian methods)) incorporates the use of simulating the planned study data and getting the desired estimates to Validate the assumptions.This method of validation can be used to improve the accuracy of data analysis, ensuring that results are as valid and reliable as possible, which allow us to make informed decisions well ahead of study initiation. With professional precision, this technique based on the collected data allows to gain insight into best practices when using data from historical study and simulated data alike.

Keywords: adaptive design, simulation, borrowing data, bayesian model

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Authors: Haidy Weliam Megaly Gouda

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Dermatology is often a neglected specialty in low-resource settings despite the high morbidity associated with skin disease. This becomes even more significant when associated with HIV infection, as dermatological conditions are more common and aggressive in HIV-positive patients. African countries have the highest HIV infection rates, and skin conditions are frequently misdiagnosed and mismanaged because of a lack of dermatological training and educational material. The frequent lack of diagnostic tests in the African setting renders basic clinical skills all the more vital. This project aimed to improve the diagnosis and treatment of skin disease in the HIV population in a district hospital in Malawi. A basic dermatological clinical tool was developed and produced in collaboration with local staff and based on available literature and data collected from clinics. The aim was to improve diagnostic accuracy and provide guidance for the treatment of skin disease in HIV-positive patients. A literature search within Embassy, Medline and Google Scholar was performed and supplemented through data obtained from attending 5 Antiretroviral clinics. From the literature, conditions were selected for inclusion in the resource if they were described as specific, more prevalent, or extensive in the HIV population or have more adverse outcomes if they develop in HIV patients. Resource-appropriate treatment options were decided using Malawian Ministry of Health guidelines and textbooks specific to African dermatology. After the collection of data and discussion with local clinical and pharmacy staff, a list of 15 skin conditions was included, and a booklet was created using the simple layout of a picture, a diagnostic description of the disease and treatment options. Clinical photographs were collected from local clinics (with full consent of the patient) or from the book ‘Common Skin Diseases in Africa’ (permission granted if fully acknowledged and used in a not-for-profit capacity). This tool was evaluated by the local staff alongside an educational teaching session on skin disease. This project aimed to reduce uncertainty in diagnosis and provide guidance for appropriate treatment in HIV patients by gathering information into one practical and manageable resource. To further this project, we hope to review the effectiveness of the tool in practice.

Keywords: prevalence and pattern of skin diseases, impact on quality of life, rural Nepal, interventions, quality switched ruby laser, skin color river blindness, clinical signs, circularity index, grey level run length matrix, grey level co-occurrence matrix, local binary pattern, object detection, ring detection, shape identification

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Authors: Maria Pratt, Lynn Martin

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Context: In nursing education, clinical instructors are crucial in assessing and evaluating students' performance in clinical courses. However, instructors often struggle when assigning failing grades to students at risk of failing. Research Aim: This qualitative study aims to understand clinical instructors' experiences evaluating students with unsatisfactory performance, including how reflection and collegial support impact this evaluation process. Methodology, Data Collection, and Analysis Procedures: This study employs Gadamer's Hermeneutic Inquiry as the research methodology. A purposive maximum variation sampling technique was used to recruit eight clinical instructors from a collaborative undergraduate nursing program in Southwestern Ontario. Semi-structured, open-ended, and audio-taped interviews were conducted with the participants. The hermeneutic analysis was applied to interpret the interview data to allow for a thorough exploration and interpretation of the instructors' experiences evaluating failing students. Findings: The main findings of this qualitative research indicate that evaluating failing students was emotionally draining for the clinical instructors who experienced multiple challenges, uncertainties, and negative feelings associated with assigning failing grades. However, the analysis revealed that ongoing reflection and collegial support played a crucial role in mitigating the challenges they experienced. Conclusion: This study contributes to the theoretical understanding of nursing education by shedding light on clinical instructors' challenges in evaluating failing students. It emphasizes the emotional toll associated with this process and the role that reflection and collegial support play in alleviating those challenges. The findings underscore the need for ongoing professional development and support for instructors in nursing education. By understanding and addressing clinical instructors' experiences, nursing education programs can better equip them to effectively evaluate struggling students and provide the necessary support for their professional growth.

Keywords: clinical instructor, student evaluation, nursing, reflection, support

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Authors: Simone Huber, Bianca Schnalzer, Baptiste Alcalde, Sten Hanke, Lampros Mpaltadoros, Thanos G. Stavropoulos, Spiros Nikolopoulos, Ioannis Kompatsiaris, Lina Pérez- Breva, Vallivana Rodrigo-Casares, Jaime Fons-Martínez, Jeroen de Bruin

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Developing new medicine and health solutions and improving patient health currently rely on the successful execution of clinical trials, which generate relevant safety and efficacy data. For their success, recruitment and retention of participants are some of the most challenging aspects of protocol adherence. Main barriers include: i) lack of awareness of clinical trials; ii) long distance from the clinical site; iii) the burden on participants, including the duration and number of clinical visits and iv) high dropout rate. Most of these aspects could be addressed with a new paradigm, namely the Remote Decentralized Clinical Trials (RDCTs). Furthermore, the COVID-19 pandemic has highlighted additional advantages and challenges for RDCTs in practice, allowing participants to join trials from home and not depend on site visits, etc. Nevertheless, RDCTs should follow the process and the quality assurance of conventional clinical trials, which involve several processes. For each part of the trial, the Building Blocks, existing software and technologies were assessed through a systematic search. The technology needed to perform RDCTs is widely available and validated but is yet segmented and developed in silos, as different software solutions address different parts of the trial and at various levels. The current paper is analyzing the availability of technology to perform RDCTs, identifying gaps and providing an overview of Basic Building Blocks and functionalities that need to be covered to support the described processes.

Keywords: architectures and frameworks for health informatics systems, clinical trials, information and communications technology, remote decentralized clinical trials, technology availability

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Authors: Gusa Hall, Barrie Keeler, Achal Khanna

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Introduction: NICE guidelines have highlighted the consequences of IV fluid mismanagement. The main aim of this study was to audit fluid prescribing post laparotomies to identify if fluids were prescribed in accordance to NICE guidelines. Methodology: Retrospective database search of eight specific laparotomy procedures (colectomy right and left, Hartmann’s procedure, small bowel resection, perforated ulcer, abdominal perineal resection, anterior resection, pan proctocolectomy, subtotal colectomy) highlighted 29 laparotomies between April 2019 and May 2019. Two of 29 patients had secondary procedures during the same admission, n=27 (patients). Database case notes were reviewed for date of procedure, length of admission, fluid prescribed and amount, nasal gastric tube output, daily bloods results for electrolytes sodium and potassium and operational losses. Results: n=27 based on 27 identified patients between April 2019 – May 2019, 93% (25/27) received IV fluids, only 19% (5/27) received the correct IV fluids in accordance to NICE guidelines, 93% (25/27) who received IV fluids had the correct electrolytes levels (sodium & potassium), 100% (27/27) patients received blood tests (U&E’s) for correct electrolytes levels. 0% (0/27) no documentation on operational losses. IV fluids matched nasogastric tube output in 100% (3/3) of the number of patients that had a nasogastric tube in situ. Conclusion: A PubMed database literature review on barriers to safer IV prescribing highlighted educational interventions focused on prescriber knowledge rather than how to execute the prescribing task. This audit suggests IV fluids post laparotomies are not being prescribed consistently in accordance to NICE guidelines. Surgical management plans should be clearer on IV fluids and electrolytes requirements for the following 24 hours after the plan has been initiated. In addition, further teaching and training around IV prescribing is needed together with frequent surgical audits on IV fluid prescribing post-surgery to evaluate improvements.

Keywords: audit, IV Fluid prescribing, laparotomy, NICE guidelines

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Authors: Mary Wangari Kamau, Agatha Christine Atieno, Louise Wanjiku Ngugi

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Diabetes Mellitus Type 2 is a prevalent disease in Kenya, with complications often resulting from poor adherence to dietary guidelines. This study aims to identify and understand the factors influencing adherence to diet guidelines among patients with Diabetes Mellitus Type 2 at a specific clinic in Kenya. The findings will contribute to the improvement of nutrition care for diabetic patients. Research Aim: The main objective of this study was to determine the factors that influence adherence to dietary guidelines among patients with Diabetes Mellitus Type 2. Specifically, the study described the level of diet adherence, identified factors influencing adherence using the ecological approach, and determined the relationships among these factors. Methodology: A cross-sectional study design was utilized at the Cancer and Chronic Diseases Center at Moi Teaching and Referral Hospital in Kenya. The sample size consisted of 241 respondents from a target population of 412. Data was collected using food frequency questionnaires, three-day food records, and key informant interviews. Descriptive statistics were used to assess diet adherence, and chi-square and odds ratio tests were applied to identify factors at various levels of the ecological model. Multiple linear regression was employed to determine the relationship between diet adherence and ecological factors. Findings: The mean level of adherence to recommended dietary guidelines for Diabetes Mellitus Type 2 patients was 48.6%. Individual level factors, such as marital status, monthly income, duration of Diabetes Mellitus, frequency of monitoring blood sugar levels, treatment for Diabetes Mellitus, and BMI, were found to significantly influence diet adherence. However, cognitive and psychological factors at the individual level were not significantly associated with adherence. No significant associations were found between adherence and factors at small group, organizational or health care system, community, and policy levels. However, when considering all levels collectively, 43% of the variance in diet adherence could be explained. Theoretical Importance: This study highlights that while individual factors play a significant role in adherence to dietary guidelines, environmental factors also have an influence. The findings support the need for health professionals and policymakers to consider factors at multiple levels when improving adherence to dietary guidelines for diabetic patients. Data Collection and Analysis Procedures: Data was collected through questionnaires and interviews, including food frequency questionnaires and three-day food records. Descriptive statistics, chi-square tests, odds ratio tests, and multiple linear regression were used to analyze the data. Questions Addressed: The study addresses the following questions: 1. What is the level of adherence to dietary guidelines among patients with Diabetes Mellitus Type 2? 2. Which factors at individual, small group, organizational or health care system, community, and policy levels influence diet adherence? 3. What is the relationship between these factors and diet adherence? Conclusion: The study findings emphasize the need to consider both individual and environmental factors when promoting adherence to dietary guidelines among patients with Diabetes Mellitus Type 2. Health professionals and policymakers should incorporate factors at multiple levels to improve the nutrition care process for diabetic patients.

Keywords: adherence, dietary guidelines, ecological factors, type 2 diabetes mellitus

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Authors: Xing Zhang

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Since the State Council of China issued the Regulations on the Conservation of Historical Cultural Towns and Villages in 2008, formulation of conservation planning has been carried out in national, provincial and municipal historical and cultural villages for protection needs, which provides a legal basis for inheritance of historical culture and protection of historical resources. Although the quantity and content of the conservation planning are continually increasing, the implementation and application are still ambiguous. To solve the aforementioned problems, this paper explores methods to enhance the implementation of conservation planning from the perspective of planning formulation. Specifically, the technical framework of "overall objectives planning - sub-objectives planning - zoning guidelines - implementation by stages" is proposed to implement the planning objectives in different classifications and stages. Then combined with details of the Qiqiao historical and cultural village conservation planning project in Ningbo, five sub-objectives are set, which are implemented through the village zoning guidelines. At the same time, the key points and specific projects in the near-term, medium-term and long-term work are clarified, and the spatial planning is transformed into the action plan with time scale. The proposed framework and method provide a reference for the implementation and management of the conservation planning of historical and cultural villages in the future.

Keywords: conservation planning, planning by stages, planning implementation, zoning guidelines

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Authors: Rashida Suleiman, Asamoah Jnr. Boakye, Suleiman Ahmed Ibn Ahmed

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In recent years, there has been an enormous success in discoveries of scientific knowledge in medicine coupled with the advancement of technology. Despite all these successes, diagnoses and treatment of diseases have become complex. MYCIN is a groundbreaking illustration of a clinical decision support system (CDSS), which was developed to assist physicians in the diagnosis and treatment of bacterial infections by providing suggestions for antibiotic regimens. MYCIN was one of the earliest expert systems to demonstrate how CDSSs may assist human decision-making in complicated areas. Relevant databases were searched using google scholar, PubMed and general Google search, which were peculiar to clinical decision support systems. The articles were then screened for a comprehensive overview of the functionality, consultative style and statistical usage of MYCIN, a clinical decision support system. Inferences drawn from the articles showed some usage of MYCIN for problem-based learning among clinicians and students in some countries. Furthermore, the data demonstrated that MYCIN had completed clinical testing at Stanford University Hospital following years of research. The system (MYCIN) was shown to be extremely accurate and effective in diagnosing and treating bacterial infections, and it demonstrated how CDSSs might enhance clinical decision-making in difficult circumstances. Despite the challenges MYCIN presents, the benefits of its usage to clinicians, students and software developers are enormous.

Keywords: clinical decision support system, MYCIN, diagnosis, bacterial infections, support systems

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Authors: Yutong Xu, Wanting Zhang, Jia Wang, Zihan Guo, Weiguang Ma

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Background: The resilience education of intern nursing students has significant implications for the development and improvement of the nursing workforce. The clinical internship period is a critical time for enhancing resilience. Aims: To evaluate the resilience level of Chinese nursing interns and identify the factors affecting resilience early in their careers. Methods: The cross-sectional study design was adopted. From March 2022 to May 2023, 512 nursing interns in tertiary care hospitals were surveyed online with the Connor-Davidson Resilience Scale, the Clinical Learning Environment scale for Nurse, and the Career Adapt-Abilities Scale. Structural equation modeling was used to clarify the relationships among these factors. Indirect effects were tested using bootstrapped Confidence Intervals. Results: The nursing interns showed a moderately high level of resilience[M(SD)=70.15(19.90)]. Gender, scholastic attainment, had a scholarship, career adaptability and clinical learning environment were influencing factors of nursing interns’ resilience. Career adaptability and clinical learning environment positively and directly affected their resilience level (β = 0.58, 0.12, respectively, p＜0.01). career adaptability also positively affected career adaptability (β = 0.26, p < 0.01), and played a fully mediating role in the relationship between clinical learning environment and resilience. Conclusion: Career adaptability can enhance the influence of clinical learning environment on resilience. The promotion of career adaptability and the clinical teaching environment should be the potential strategies for nursing interns to improve their resilience, especially for those female nursing interns with low academic performance. Implications for Nursing Educators Nursing educators should pay attention to the cultivation of nursing students' resilience; for example, by helping them integrate to the clinical learning environment and improving their career adaptability. Reporting Method: The STROBE criteria were used to report the results of the observations critically. Patient or Public Contribution No patient or public contribution.

Keywords: resilience, clinical learning environment, career adaptability, nursing interns

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Authors: Max Butler

Abstract:

Melanoma accounts for 80% of skin cancer-related deaths globally. The poor prognosis and increasing incidence of melanoma impose a significant burden on global healthcare systems. Early detection, precise diagnosis, and preventative strategies are critical to improving patient outcomes. Dermoscopy is the gold standard for specialist assessments of pigmented skin lesions, as it can differentiate between benign and malignant growths with greater accuracy than visual inspection. In the United Kingdom, guidelines from the National Institute of Clinical Excellence (NICE) state dermoscopy should be used in all specialist assessments of pigmented skin lesions. Compliance with this guideline is low, resulting in missed and delayed melanoma diagnoses. To address this problem, a quality improvement project was initiated at Buckinghamshire Healthcare Trust (BHT) within the plastic surgery department. The target group was a trainee and consultant plastic surgeons conducting outpatient skin cancer clinics. Analysis of clinic documentation over a one-month period found that only 62% (38/61) of patients referred with pigmented skin lesions were examined using dermoscopy. To increase dermoscopy rates, teaching was delivered to the department highlighting national guidelines and the evidence base for dermoscopic examination. In addition, clinic paperwork was redesigned to include a text box for dermoscopic examination. Reauditing after the intervention found a significant increase in dermoscopy rates (52/61, p = 0.014). In conclusion, implementing a quality improvement project with targeted teaching and documentation template templates successfully increased dermoscopy rates. This is a promising step toward improving early melanoma detection and patient outcomes.

Keywords: melanoma, dermoscopy, plastic surgery, quality improvement

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Authors: Azizah Che Omar

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The study provides a systematic literature review which analyzed the literature for the purpose of looking for concepts, theories, approaches and guidelines in order to propose a conceptual design model of interactive television advertising toward impulse purchase (iTVAdIP). An extensive review of literature was purposely carried out to understand the concepts of interactive television (iTV). Therefore, some elements; iTV guidelines, advertising theories, persuasive approaches, and the impulse purchase elements were analyzed to reach the scope of this work. The extensive review was also a necessity to achieve the objective of this study, which was to determine the concept of iTVAdIP design model. Through systematic review analysis, this study discovered that all the previous models did not emphasize the conceptual design model of interactive television advertising. As a result, the finding showed that the concept of the proposed model should contain the iTV guidelines, advertising theory, persuasive approach and impulse purchase elements. In addition, a summary diagram for the development of the proposed model is depicted to provide clearer understanding towards the concepts of conceptual design model of iTVAdIP.

Keywords: impulse purchase, interactive television advertising, human computer interaction, advertising theories

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Authors: Pennapa Palapin

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This study aimed to examine the management and development of forest tourism Kamchanoad. Ban Dung, Udon Thani sustainability. Data were collected by means of qualitative research including in-depth interviews, semi-structured, and then the data were summarized and discussed in accordance with the objectives. And make a presentation in the form of lectures. The target population for the study consisted of 16 people, including representatives from government agencies, community leaders and the community. The results showed that Guidelines for the Management and Development of Forest Tourism Kamchanoad include management of buildings and infrastructure such as roads, water, electricity, toilets. Other developments are the establishment of a service center that provides information and resources to facilitate tourists.; nature trails and informative signage to educate visitors on the path to the jungle Kamchanoad; forest activities for tourists who are interested only in occasional educational activities such as vegetation, etc.; disseminating information on various aspects of tourism through various channels in both Thailand and English, as well as a website to encourage community involvement in the planning and management of tourism together with the care and preservation of natural resources and preserving the local cultural tourist area of Kamchanoad.

Keywords: guidelines for the management and development, forest tourism, Kamchanoad, sustainability

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Authors: Yong Cang

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RJV001 is a subcutaneous injection containing mutated recombinant Collagenase H (ColH), leading to disruption of collagen matrix in adipose tissue and programmed cell death of adipocytes. Here we reported our clinical investigation of the safety, tolerance and pharmacodynamics of localized RJV001 injection into healthy human abdominal fat tissues (NCT04821648, Arizona Research Center). Investigate the safety, tolerance and clinical pharmacodynamics of subcutaneous RJV001 in humans. In the dose-escalating study, 18 subjects completed the study, 100% female, 78% white, with a mean age of 42[±9.9]. All three tested dose (0.05, 0.075 and 0.15 mg/injection), up to 30 injections, were safe and well-tolerated. Bruising and tenderness to palpation, mild to moderate, were the most frequent local skin reactions but nearly all resolved within 30 days. Additionally, physician-monitored ultrasound measurement showed that a reduction in abdominal fat tissue thickness was consistently observed in Cohort C (0.075, 0.15 mg/injection, 30injections), with a mean reduction of 7.37 [± 2.020] mm. Based on this clinical study, RJV001 has been advanced to phase II clinical studies. In the dose-escalating study, subcutaneously administered RJV001 was safe and well-tolerated in healthy adults up to 0.15 mg/injection, 30 injections. Fat reduction and adipocytolysis were observed by ultrasound measurements and histological analysis for exploratory purposes.

Keywords: fat reduction, mutant collagenase, clinical trial, subcutaneous injection

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

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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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Authors: Georgia Mills, Rachel Parsonage

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Thrombocytosis is a platelet count above the upper limit of the normal range. An urgent referral is advised for counts over 1000 x109 and if the count is between 600-1000 x109 with certain conditions/age. A non-urgent referral is warranted when the level is above 450 × 109/L (for more than 3 months) or over 600 × 109/L on at least two occasions (4–6 weeks apart) or within the range 450–600 × 109/L with other haematological abnormalities. The aim of this audit is the assess how well Roseneath's general practice has adhered to the National Institute for Health and Care Excellence (NICE) guidelines for investigations and management of high platelet counts. Through the filtering tool on Vision, all blood results in the surgery were filtered to only show those with a platelet count above 450 x 109 /L. These patients were then analyzed individually to see where they fall on the current NICE guidance pathway for management. The investigations and management of thrombocytosis were generally poor. 60% of those who needed an urgent referral did not have it done. 30% of those who needed a follow-up blood test did not have it done. 60% of those needing a routine referral from complete investigations did not have it done. To improve the knowledge of NICE guidelines within the practice, a teaching session was delivered. Percentages then reached 100% in the 2nd audit. There is a lack of awareness of guidelines and education on thrombocytosis in primary care. Teaching sessions will benefit outcomes greatly

Keywords: platelets, thrombocytosis, management, referral

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Authors: Liane J. Ioannou, Jonathan Serpell, Cino Bendinelli, David Walters, Jenny Gough, Dean Lisewski, Win Meyer-Rochow, Julie Miller, Duncan Topliss, Bill Fleming, Stephen Farrell, Andrew Kiu, James Kollias, Mark Sywak, Adam Aniss, Linda Fenton, Danielle Ghusn, Simon Harper, Aleksandra Popadich, Kate Stringer, David Watters, Susannah Ahern

Abstract:

BACKGROUND: There are significant variations in the management, treatment and outcomes of thyroid cancer, particularly in the role of: diagnostic investigation and pre-treatment scanning; optimal extent of surgery (total or hemi-thyroidectomy); use of active surveillance for small low-risk cancers; central lymph node dissections (therapeutic or prophylactic); outcomes following surgery (e.g. recurrent laryngeal nerve palsy, hypocalcaemia, hypoparathyroidism); post-surgical hormone, calcium and vitamin D therapy; and provision and dosage of radioactive iodine treatment. A proven strategy to reduce variations in the outcome and to improve survival is to measure and compare it using high-quality clinical registry data. Clinical registries provide the most effective means of collecting high-quality data and are a tool for quality improvement. Where they have been introduced at a state or national level, registries have become one of the most clinically valued tools for quality improvement. To benchmark clinical care, clinical quality registries require systematic measurement at predefined intervals and the capacity to report back information to participating clinical units. OBJECTIVE: The aim of this study was to develop a core set clinical indicators that enable measurement and reporting of quality of care for patients with thyroid cancer. We hypothesise that measuring clinical quality indicators, developed to identify differences in quality of care across sites, will reduce variation and improve patient outcomes and survival, thereby lessening costs and healthcare burden to the Australian community. METHOD: Preparatory work and scoping was conducted to identify existing high quality, clinical guidelines and best practice for thyroid cancer both nationally and internationally, as well as relevant literature. A bi-national panel was invited to participate in a modified Delphi process. Panelists were asked to rate each proposed indicator on a Likert scale of 1–9 in a three-round iterative process. RESULTS: A total of 236 potential quality indicators were identified. One hundred and ninety-two indicators were removed to reflect the data capture by the Australian and New Zealand Thyroid Cancer Registry (ANZTCR) (from diagnosis to 90-days post-surgery). The remaining 44 indicators were presented to the panelists for voting. A further 21 indicators were later added by the panelists bringing the total potential quality indicators to 65. Of these, 21 were considered the most important and feasible indicators to measure quality of care in thyroid cancer, of which 12 were recommended for inclusion in the final set. The consensus indicator set spans the spectrum of care, including: preoperative; surgery; surgical complications; staging and post-surgical treatment planning; and post-surgical treatment. CONCLUSIONS: This study provides a core set of quality indicators to measure quality of care in thyroid cancer. This indicator set can be applied as a tool for internal quality improvement, comparative quality reporting, public reporting and research. Inclusion of these quality indicators into monitoring databases such as clinical quality registries will enable opportunities for benchmarking and feedback on best practice care to clinicians involved in the management of thyroid cancer.

Keywords: clinical registry, Delphi survey, quality indicators, quality of care

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Authors: Hatice Akbıyık, Hülya Gökmen Özel, Nagehan Emiralioğlu, Elmas Ebru Güneş Yalçın, Deniz Doğru Ersöz, Hayriye Uğur Özçelik, Nural Kiper

Abstract:

Background: Dietary recommendations in cystic fibrosis (CF) are based on the need to compensate for the increased energy needs of infection, the increased energy cost of breathing and the losses, incurred from malabsorption. Studies in CF indicate that dietary recommendations for CF patients can be difficult to achieve Aim: The aim of this study was to evaluate the energy and nutrient intakes and to compare in accordance with CF dietary guidelines in CF. Methods: One-hundred sixty patients with CF, aged between 2 to 20 years (mean±SD= 7.4±4.8 years) attending Hacettepe University, Faculty of Medicine, Department of Pediatric Pulmonary Diseases were included. Energy and nutrient intakes from foods and enteral products were calculated using a-24-hour dietary recall method with BEBIS 7.2 programme. Percentages of energy and nutrient intakes were compared in accordance with CF dietary guidelines. Patients or/and parents completed a questionnaire showing mealtime problems, usage of alternative therapies and type of nutrition. Statistical analyses were done using SPSS 16.0 programme. Results: It was obtained that 14.5% and 46.9% of the total energy intake were from proteins and carbohydrates, respectively. The actual contribution of total, saturated, monounsaturated and polyunsaturated fats to the total caloric intake was 37.5%, 14.3%, 14.9%, 9.9%, respectively. It was found that 87.7% of energy, 85% of protein 91.7% of carbohydrate, 81.1% of fat intakes were met, when compared CF recommended intakes of 120% RDA. Additionally 67%, 69.5%, 68.2% and 68.9% of the subjects did not achieve CF recommended intakes of 120% RDA for energy, protein, carbohydrate and fat, respectively. Patients with CF had low intakes for age for almost all vitamins and minerals, although supplementation was given. Especially most patients did not achieve the minimum recommended vitamin K intake of 120% RDA. The percentage meeting 120% RDA was 75.9% for vitamin K. It was shown that 41% of the patients had mealtime problems and they skipped the breakfast. Moreover 25.4% of the patients used alternative products outside the standard treatment (such as omega-3, ginger, turmeric, local honey). It was also showed that 60.8% of patients were using enteral products in addition to normal foods, the remaining patients were on only normal foods. Conclusion: The aims of improving nutritional status in children are to achieve normal weight gain and growth; optimize vitamin and mineral status; and slow the rate of clinical decline. In this study although enteral products were used in patients with CF, it was found that energy and nutrient requirements were unable to meet. Because dietary assessment is essential to identify the need for earlier nutritional intervention, in each visit patients need to be referred to CF specialist dietitian.

Keywords: cystic fibrosis, energy and nutrient intakes, mealtime problems, malabsorbtion

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Authors: Choppala Pratheek, Vineet Ahuja

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Background: Crohn's disease (CD) recurrence following surgery is a common challenge, and current detection methods rely on risk factors identified in Western populations. This study aimed to investigate the risk factors and rates of postoperative CD recurrence in a tuberculosis-endemic region like India. Retrospective data was collected from a structured database from a specialty IBD clinic by reviewing case files from January 2005 to December 2021. Inclusion criteria involved CD patients diagnosed based on the ECCO-ESGAR consensus guidelines, who had undergone at least one intestinal resection and had a minimum follow-up period of one year at the IBD clinic. Results: A total of 90 patients were followed up for a median period of 45 months (IQR, 20.75 - 72.00). Out of the 90 patients, 61 received ATT prior to surgery, with a mean delay in diagnosis of 2.5 years, although statistically non-significant (P=0.078). Clinical recurrence occurred in 50% of patients, with the cumulative rate increasing from 13.3% at one year to 40% at three years. Among 63 patients who underwent endoscopy, 65.7% showed evidence of endoscopic recurrence, with the cumulative rate increasing from 31.7% at one year to 55.5% at four years. Smoking was identified as a significant risk factor for early endoscopic recurrence (P=0.001) by Cox regression analysis, but no other risk factors were identified. Initiating post-operative medications prior to clinical recurrence delayed its onset (P=0.004). Subgroup analysis indicated that endoscopic monitoring aided in the early identification of recurrence (P=0.001). The findings contribute to enhancing post-operative CD management strategies in such regions where the disease burden is escalating.

Keywords: crohns, post operative, tuberculosis-endemic, risk factors

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