Search results for: clinical experimentation

Authors: Sandra Cardoso, Gaspar Pais, Judite Neves, Sandra Cavaca, Fernando Araújo

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In 2021, Portugal has 63 emergency department (ED) visits per 100 people annually, the highest numbers in Europe. While EDs provide a critical service, high use is indicative of inappropriate and inefficient healthcare. In Portugal, all ED have the Manchester Triage System (MTS), a clinical risk management tool to enable that patients are seen in order of clinical priority. In 2023, more than 40% of the ED visits were of non-urgent conditions (blue and green), that could be better managed in primary health care (PHC), meaning wrong use of resources and lack of health literacy. From 2017, the country has a phone line, SNS24 (Contact Centre of the National Health Service), for triage, counseling, and referral service, 24 hours/7 days a week. The pilot project ‘Call before, save lives’ was implemented in the municipalities of Póvoa de Varzim and Vila do Conde (around 150.000 residents), in May 2023, by the executive board of the Portuguese Health Service, with the support of the Shared Services of the Ministry of Health, and local authorities. This geographical area has short travel times, 99% of the population a family doctor and the region is organized in a health local unit (HLU), integrating PHC and the local hospital. The purposes of this project included to increase awareness to contact SNS 24, before going to an ED, and non-urgent conditions oriented to a family doctor, reducing ED visits. The implementation of the project involved two phases, beginning with: i) development of campaigns using local influencers (fishmonger, model, fireman) through local institutions and media; ii) provision of telephone installed on site to contact SNS24; iii) establishment of open consultation in PHC; iv) promotion of the use of SNS24; v) creation of acute consultations at the hospital for complex chronic patients; and vi) direct referral for home hospitalization by PHC. The results of this project showed an excellent level of access to SNS24, an increase in the number of users referred to ED, with great satisfaction of users and professionals. The second phase, initiated in January 2024, for access to the ED, the need for prior referral was established as an admission rule, except for certain situations, as trauma patients. If the patient refuses, their registration in the ED and subsequent screening in accordance with the MTS must be ensured. When the patient is non-urgent, shall not be observed in the ED, provided that, according to his clinical condition, is guaranteed to be referred to PHC or to consultation/day hospital, through effective scheduling of an appointment for the same or the following day. In terms of results, 8 weeks after beginning of phase 2, we assist of a decrease in self-reported patients to ED from 59% to 15%, and a reduction of around 7% of ED visits. The key for this success was an effective public campaign that increases the knowledge of the right use of the health system, and capable of changing behaviors.

Keywords: contact centre of the national health service, emergency department visits, public campaign, health literacy, SNS24

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Authors: Hilary Modir, Kyle Dutton, Michelle Swab, Shabnam Asghari

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Since its emergence, the cutaneous manifestations of COVID-19 have been documented in the literature. However, the majority are case reports with significant limitations in appraisal quality, thus leaving the role of dermatological manifestations of COVID-19 erroneously underexplored. The primary aim of this review was to systematically examine clinical patterns of dermatological manifestations as reported in the literature. This study was designed as a systematic review of case reports. The inclusion criteria consisted of all published reports and articles regarding COVID-19 in English, from September 1st, 2019, until June 22nd, 2020. The population consisted of confirmed cases of COVID-19 with associated cutaneous signs and symptoms. Exclusion criteria included research in planning stages, protocols, book reviews, news articles, review studies, and policy analyses. With the collaboration of a librarian, a search strategy was created consisting of a mixture of keyword terms and controlled vocabulary. Electronic databases searched were MEDLINE via PubMed, EMBASE, CINAHL, Web of Science, LILACS, PsycINFO, WHO Global Literature on Coronavirus Disease, Cochrane Library, Campbell Collaboration, Prospero, WHO International Clinical Trials Registry Platform, Australian and New Zealand Clinical Trials Registry, U.S. Institutes of Health Ongoing Trials Register, AAD Registry, OSF preprints, SSRN, MedRxiV and BioRxiV. The study selection featured an initial pre-screening of titles and abstracts by one independent reviewer. Results were verified by re-examining a random sample of 1% of excluded articles. Eligible studies progressed for full-text review by two calibrated independent reviewers. Covidence was used to store and extract data, such as citation information and findings pertaining to COVID-19 and cutaneous signs and symptoms. Data analysis and summarization methodology reflect the framework proposed by PRISMA and recommendations set out by Cochrane and Joanna Brigg’s Institute for conducting systematic reviews. The Oxford Centre for Evidence-Based Medicine’s level of evidence was used to appraise the quality of individual studies. The literature search revealed a total of 1221 articles. After the abstract and full-text screening, only 95 studies met the eligibility criteria, proceeding to data extraction. Studies were divided into 58% case reports and 42% series. A total of 833 manifestations were reported in 723 confirmed COVID-19 cases. The most frequent lesions were 23% maculopapular, 15% urticarial and 13% pseudo-chilblains, with 46% of lesions reporting pruritus, 16% erythema, 14% pain, 12% burning sensation, and 4% edema. The most common lesion locations were 20% trunk, 19.5% lower limbs, and 17.7% upper limbs. The time to resolution of lesions was between one and twenty-one days. In conclusion, over half of the reported cutaneous presentations in COVID-19 positive patients were maculopapular, urticarial and pseudo-chilblains, with the majority of lesions distributed to the extremities and trunk. As this review’s sample size only contained COVID-19 confirmed cases with skin presentations, it becomes difficult to deduce the direct relationship between skin findings and COVID-19. However, it can be correlated that acute onset of skin lesions, such as chilblains-like, may be associated with or may warrant consideration of COVID-19 as part of the differential diagnosis.

Keywords: COVID-19, cutaneous manifestations, cutaneous signs, general dermatology, medical dermatology, Sars-Cov-2, skin and infectious disease, skin findings, skin manifestations

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Authors: Yunhe Chen, Xinyun Liu, Qian Wang, Jianan Li

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Background Cochlear implants (CIs) are currently the primary effective treatment for severe or profound sensorineural hearing loss. As China's population ages and the number of young children rises, the demand for MRI for CI patients is expected to increase. Methods Reviewed MRI cases of 25 CI patients between 2015 and 2024, assessed imaging auditory outcomes and adverse reactions. Use the adverse event record sheet and accompanying medication sheet to record follow-up measures. Results Most CI patients undergoing MRI may face risks such as artifacts, pain, redness, swelling, tissue damage, bleeding, and magnet displacement or demagnetization. Twenty-five CI patients in our hospital were reviewed. Seven patient underwent 3.0 T MR, the others underwent 1.5 T MR. The manufacturers are 18 cases in Austria, 5 cases in Australia and 2 cases in Nurotron. Among them, one patient with bilateral CI underwent 1.5 T MR examination after head pressure bandaging, and the left magnet was displaced (CI24RE Series, Australia). This patient underwent surgical replacement of the magnet under general anesthesia. Six days after the operation, the patient's feedback indicated that the performance of the cochlear implant was consistent with the previous results following the reactivation of the external device. Based on the experience of our hospital, we proposed the feasible management scheme of MRI examination procedure for CI patients. This plan should include a module for confirming MRI imaging parameters, informed consent, educational materials for patients, and other safety measures to ensure that patients receive imaging results safely and effectively, implify clinical. Conclusion As indications for both MRI and cochlear implantation expand，the number of MRI studies recommended for patients with cochlear implants will also increase. The process and management scheme proposed in this study can help to obtain imaging results safely and effectively, and reduce clinical stress.

Keywords: cochlear implantation, MRI, magnet, displacement

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Authors: Neha Joshi, Srikanth Jois, Hector J. Peughero, Poornima Jayakrishna, Moulya R., Purnima Madivanan, Kiran Kumar K. Salagame

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Transgenders are a marginalized section of the community, who are at high risk of mental health problems due to their stigmatization, abandonment by family, prejudice, discrimination by society at large, and the physical, emotional, and sexual abuse from both within and outside their community. Their mental healthcare needs remain largely unaddressed due to lack of access, discrimination by healthcare professions, and lack of resources, including time and money, to seek conventional medical and psychotherapeutic treatments. Meditation is increasingly receiving acceptance as a tool for managing stress and anxiety by the patients as well as mental healthcare professionals. “Meditation on Twin Hearts” is a no cost, self-administered intervention that a person can practice anywhere and at any time of the day. This pilot study evaluates the need for alternate traditional and ingenious interventions like “Meditation of Twin Hearts” to address the mental healthcare needs of the transgender community and acceptance of such an intervention by the community. Thirteen individuals identifying themselves as transgender were invited to participate in one (Hunsur Taluk) of the five scheduled free meditation camps in Mysore. After obtaining informed consent for participation in the study, their mental health status is captured using an anonymous survey using standard, validated, self-reported questionnaires Generalised Anxiety Disorders (GAD)-7 for anxiety, Patient Health Questionnaire (PHQ-9) for depression, and Suicidal Behavior Questionnaire-Revised for suicidality. Then, they were requested to attend a session on “Meditation on Twin Hearts.” After the session, their feedback on willingness to further explore the meditation technique for managing their mental healthcare need was assessed through another survey form. Out of the 13 participants, 92% scored for anxiety (4 mild, and 8 moderate anxiety). In the depression scale, 5 scored for mild and 5 for moderate depression, with a total of 77% (10/13) scoring positively on depression scale. Nearly 70% of participants (9/13), scored greater than the clinical cutoff for the need for clinical intervention. The proportion of individuals at risk for suicide was particularly high in this group, with 8/ 13 (61.5%) participants scoring the clinical cutoff score of ≥ 7. Surprisingly, none of the participants had ever consulted a mental healthcare professional. All the participants (13/13; 100%) responded in affirmative to the question, “Will you be willing to continue meditation for management of your anxiety?” Six out of 13 participants described their experience of meditation as “happy” and 3 described it as “peaceful”. None of the participants reported any negative beliefs or experience regarding the meditation. The study provides evidence for the urgent yet unmet mental healthcare need of the transgender community. The findings of the study also supports the rationale of conducting future systematic research to evaluate and explore ingenious and traditional practices, such as meditation, to meet the healthcare needs, especially in marginalized populations in a low income setting such as Lower and Middle Income countries. Based on these preliminary findings, the Principal Investigator (PI) is planning to cover 4 more areas of Mysore district.

Keywords: anxiety, depression, meditation on twin heart, suicidality, transgender

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Authors: Hasn Perera, Is Almeida, Hnk Perera, Mzf Mohammed, Ade Silva, H. Wijesinghe, Ajal Fernando

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Introduction: Dengue is a major Public Health burden of two clinical entities, Dengue Fever & Dengue Haemorrhagic Fever (DHF). The vast majority of dengue deaths occur in DHF patients, where the diagnosis hinges on the presence of fluid leakage. Limited Ultrasound Scans (USS) of chest and abdomen are used widely at Centre for Clinical Management of Dengue & Dengue Haemorrhagic Fever (CCMDDHF), as the primary method for detecting fluid leaking in DHF. This study analyses the relationship between haematological and USS findings at the onset of leaking and to further determine the usefulness of ultrasound in diagnosing DHF. Methods: A prospective analysis of 80 serologically confirmed dengue patients initially admitted to a General Medical and Paediatric wards who were subsequently transferred to the CCMDDHF from March to September 2017 were analysed. In addition to repeated blood counts and capillary haematocrits’, serial USS were done to detect the onset fluid leaking by three competent and experienced doctors at CCMDDHF. Results: 80 patients (male: female: 38:42) with a mean age of 20 years (SD ±16.8, range 3-74) were evaluated. Dropping of platelet counts below 100,000 and haematocrit rise towards 20% started 4±1.3 day of fever with a mean platelet value of 69x103(range17-98x103). Gallbladder wall thickening was the commonest (98.7%) USS finding followed by fluid in hepato-renal pouch (95%), pelvic fluid (58.7%), right-sided pleural effusion (35%), bilateral effusions (7.5%). USS evidence of plasma leakage was detected in 11.25 %( n=9) of DHF cases from 1 day before significant haematocrit rise was noted. 35 (43.7%) patients with lowering platelets and haematocrit rise showed no objective evidence of plasma leaking on ultrasound scan. Conclusion: This outbreak underscores the importance of USS as a useful, sensitive and cost-effective tool for early diagnosis of suspected DHF cases, facilitating the tracking of progress of leaking and management of epidemics.

Keywords: dengue, ultrasound, plasma leaking, South Asia

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Authors: U. E. Mochalova, A. V. Demeneva, Shilkin A. G., J. Yu. Artiushina

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Objective. In medical ophthalmology OCT has been actively used in the last decade. It is a modern non-invasive method of high-precision hardware examination, which gives a detailed cross-sectional image of eye tissues structure with a high level of resolution, which provides in vivo morphological information at the microscopic level about corneal tissue, structures of the anterior segment, retina and optic nerve. The purpose of this study was to explore the possibility of using the OCT technology in complex ophthalmological examination in dogs and cats, to characterize the revealed pathological structural changes in corneal tissue in cats and dogs with some of the most common corneal diseases. Procedures. Optical coherence tomography of the cornea was performed in 112 animals: 68 dogs and 44 cats. In total, 224 eyes were examined. Pathologies of the organ of vision included: dystrophy and degeneration of the cornea, endothelial corneal dystrophy, dry eye syndrome, chronic superficial vascular keratitis, pigmented keratitis, corneal erosion, ulcerative stromal keratitis, corneal sequestration, chronic glaucoma and also postoperative period after performed keratoplasty. When performing OCT, we used certified medical devices: "Huvitz HOCT-1/1F», «Optovue iVue 80» and "SOCT Copernicus Revo (60)". Results. The results of a clinical study on the use of optical coherence tomography (OCT)of the cornea in cats and dogs, performed by the authors of the article in the complex diagnosis of keratopathies of variousorigins: endothelial corneal dystrophy, pigmented keratitis, chronic keratoconjunctivitis, chronic herpetic keratitis, ulcerative keratitis, traumatic corneal damage, sequestration of the cornea of cats, chronic keratitis, complicating the course of glaucoma. The characteristics of the OCT scans are givencorneas of cats and dogs that do not have corneal pathologies. OCT scans of various corneal pathologies in dogs and cats with a description of the revealed pathological changes are presented. Of great clinical interest are the data obtained during OCT of the cornea of animals undergoing keratoplasty operations using various forms of grafts. Conclusions. OCT makes it possible to assess the thickness and pathological structural changes of the corneal surface epithelium, corneal stroma and descemet membrane. We can measure them, determine the exact localization, and record pathological changes. Clinical observation of the dynamics of the pathological process in the cornea using OCT makes it possible to evaluate the effectiveness of drug treatment. In case of negative dynamics of corneal disease, it is necessary to determine the indications for surgical treatment (to assess the thickness of the cornea, the localization of its thinning zones, to characterize the depth and area of pathological changes). According to the OCT of the cornea, it is possible to choose the optimal surgical treatment for the patient, the technique and depth of optically constructive surgery (penetrating or anterior lamellar keratoplasty).; determine the depth and diameter of the planned microsurgical trepanation of corneal tissue, which will ensure good adaptation of the edges of the donor material.

Keywords: optical coherence tomography, corneal sequestration, optical coherence tomography of the cornea, corneal transplantation, cat, dog

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Authors: Dalila Lino, Maria Joao Hortas, Carla Rocha, Clarisse Nunes, Natalia Vieira, Marina Fuertes, Kátia Sa

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The value of play is recognized worldwide and is considered a fundamental right of all children, as defined in Article 31 of the United Nations Children’s Rights. It is consensual among the scientific community that play, and toys are of vital importance for children’s learning and development. Play promotes the acquisition of language, enhances creativity and improves social, affective, emotional, cognitive and motor development of young children. Young children ages 0 to 6 who have had many opportunities to get involved in play show greater competence to adapt to new and unexpected situations and more easily overcome the pain and suffering caused by traumatic situations. The PlayTrain Project aims to understand the places/spaces of play in the education of children from 0 to 6 years and promoting the training of preschool teachers to become capable of developing practices that enhance children’s agency, experimentation in the physical and social world and the development of imagination and creativity. This project follows the Design-Based-Research (DBR) and has two dimensions: research and intervention. The participants are 120 students from the Master in Pre-school Education of the Higher School of Education, Polytechnic Institute of Lisbon enrolled in the academic year 2018/2019. The development of workshops focused on the role of play and toys for young children’s learning promotes the participants reflection and the development of skills and knowledge to construct developmentally appropriated practices in early childhood education. Data was collected through an online questionnaire and focal groups. Results show that the PlayTrain Project contribute to the development of a body of knowledge about the role of play for early childhood education. It was possible to identify the needs of preschool teacher education and to enhance the discussion among the scientific and academic community about the importance of deepening the role of play and toys in the study plans of the masters in pre-school education.

Keywords: children's learning, early childhood education, play, teacher education, toys

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Authors: James Britton, Vijaya Krishna, Manus Biggs, Abhay Pandit

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Regeneration of the spinal cord after injury remains a great challenge due to the complexity of this organ. Inflammation and gliosis at the injury site hinder the outgrowth of axons and hence prevent synaptic reconnection and reinnervation. Hyaluronic acid (HA) is the main component of the spinal cord extracellular matrix and plays a vital role in cell proliferation and axonal guidance. In this study, we have synthesized and characterized a photo-cross-linkable HA-tyramine (tyr) hydrogel from a chemical, mechanical, electrical, biological and structural perspective. From our experimentation, we have found that HA-tyr can be synthesized with controllable degrees of tyramine substitution using click chemistry. The complex modulus (G*) of HA-tyr can be tuned to mimic the mechanical properties of the native spinal cord via optimization of the photo-initiator concentration and UV exposure. We have examined the degree of tyramine-tyramine covalent bonding (polymerization) as a function of UV exposure and photo-initiator use via Photo and Nuclear magnetic resonance spectroscopy. Both swelling and enzymatic degradation assays were conducted to examine the resilience of our 3D printed hydrogel constructs in-vitro. Using a femtosecond 780nm laser, the two-photon polymerization of HA-tyr hydrogel in the presence of riboflavin photoinitiator was optimized. A laser power of 50mW and scan speed of 30,000 μm/s produced high-resolution spatial patterning within the hydrogel with sustained mechanical integrity. Using dorsal root ganglion explants, the cytocompatibility of photo-crosslinked HA-tyr was assessed. Using potentiometry, the electrical conductivity of photo-crosslinked HA-tyr was assessed and compared to that of native spinal cord tissue as a function of frequency. In conclusion, we have developed a biocompatible hydrogel that can be used for photolithographic 3D printing to fabricate tissue engineered constructs for neural tissue regeneration applications.

Keywords: 3D printing, hyaluronic acid, photolithography, spinal cord injury

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Authors: Mohammad-Ali Latifi, Harry Bouwman

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Changes in the business environment accelerated dramatically over the last decades as a result of changes in technology, regulation, market, and competitors’ behavior. Firms need to change the way they do business in order to survive or maintain their growth. Innovating business model (BM) can create competitive advantages and enhance firm performance. However, many companies fail to achieve expected outcomes in practice, mostly due to irreversible fundamental changes in key components of the company’s BM. This leads to more ambiguity, uncertainty, and risks associated with business performance. However, the relationship among BM Innovation, moderating factors, and the firm’s overall performance is by and large ignored in the current literature. In this study, we identified twenty moderating factors from our comprehensive literature review. We categorized these factors based on two criteria regarding the extent to which: the moderating factors can be controlled and managed by firms, and they are generic or specific changes to the firms. This leads to four moderation groups. The first group is BM implementation, which includes management support, employees’ commitment, employees’ skills, communication, detailed plan. The second group is called BM practices, which consists of BM tooling, BM experimentation, the scope of change, speed of change, degree of novelty. The third group is Firm characteristics, including firm size, age, and ownership. The last group is called Industry characteristics, which considers the industry sector, competitive intensity, industry life cycle, environmental dynamism, high-tech vs. low-tech industry. Through collecting data from 508 European small and medium-sized enterprises (SMEs) and using the structural equation modeling technique, the developed moderation model was examined. Results revealed that all factors highlighted through these four groups moderate the relation between BMI and firm performance significantly. Particularly, factors related to BM-Implementation and BM-Practices are more manageable and would potentially improve firm overall performance. We believe that this result is more important for researchers and practitioners since the possibility of working on factors in Firm characteristics and Industry characteristics groups are limited, and the firm can hardly control and manage them to improve the performance of BMI efforts.

Keywords: business model innovation, firm performance, implementation, moderation

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Authors: Rita Alfattal, Maryam Alfarhan, Adeeb M. Algaith, Buthaina Albash, Reem M. Elshafie, Asma Alshammari, Ahmad Alahmad, Fatima Dashti, Rasha Alsafi, Hind Alsharhan

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Defects of respiratory chain complex III (CIII) result in characteristic but rare mitochondrial disorders associated with distinct neuroradiological findings. The underlying molecular defects affecting mitochondrial CIII assembly factors are few and yet to be identified. LYRM7 assembly factor is required for proper CIII assembly where it acts as a chaperone for the Rieske iron‐sulfur (UQCRFS1) protein in the mitochondrial matrix and stabilizing it. We present here the seventeenth individual with LYRM7-associated mitochondrial leukoencephalopathy harboring a previously reported rare pathogenic homozygous LYRM 7 variant, c.2T>C, (p.Met1?). Like previously reported individuals, our 4-year-old male proband presented with recurrent metabolic and lactic acidosis, encephalopathy, and myopathy. Further, he has additional, previously unreported features, including an acute stroke like episode with bilateral central blindness and optic neuropathy, recurrent hyperglycemia and hypertension associated with metabolic crisis. However, he has no signs of psychomotor regression. He has been stable clinically with residual left-sided reduced visual acuity and amblyopia, and no more metabolic crises for 2-year-period while on the mitochondrial cocktail. Although the reported brain MRI findings in other affected individuals are homogenous, it is slightly different in our index, revealing evidence of bilateral almost symmetric multifocal periventricular T2 hyperintensities with hyperintensities of the optic nerves, optic chiasm, and corona radiata but with no cavitation or cystic changes. This report describes new clinical and radiological findings of LYRM7-associated disease. The report also summarizes the clinical and molecular data of previously reported individuals describing the full phenotypic spectrum.

Keywords: LYRM7 gene defect, mitochondrial disease, , lactic acidosis, , genetic disorder

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Authors: Ayon Mukherjee

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Covariate-adjusted response-adaptive (CARA) designs use the available responses to skew the treatment allocation in a clinical trial in towards treatment found at an interim stage to be best for a given patient's covariate profile. Extensive research has been done on various aspects of CARA designs with the patient responses assumed to follow a parametric model. However, ranges of application for such designs are limited in real-life clinical trials where the responses infrequently fit a certain parametric form. On the other hand, robust estimates for the covariate-adjusted treatment effects are obtained from the parametric assumption. To balance these two requirements, designs are developed which are free from distributional assumptions about the survival responses, relying only on the assumption of proportional hazards for the two treatment arms. The proposed designs are developed by deriving two types of optimum allocation designs, and also by using a distribution function to link the past allocation, covariate and response histories to the present allocation. The optimal designs are based on biased coin procedures, with a bias towards the better treatment arm. These are the doubly-adaptive biased coin design (DBCD) and the efficient randomized adaptive design (ERADE). The treatment allocation proportions for these designs converge to the expected target values, which are functions of the Cox regression coefficients that are estimated sequentially. These expected target values are derived based on constrained optimization problems and are updated as information accrues with sequential arrival of patients. The design based on the link function is derived using the distribution function of a probit model whose parameters are adjusted based on the covariate profile of the incoming patient. To apply such designs, the treatment allocation probabilities are sequentially modified based on the treatment allocation history, response history, previous patients’ covariates and also the covariates of the incoming patient. Given these information, an expression is obtained for the conditional probability of a patient allocation to a treatment arm. Based on simulation studies, it is found that the ERADE is preferable to the DBCD when the main aim is to minimize the variance of the observed allocation proportion and to maximize the power of the Wald test for a treatment difference. However, the former procedure being discrete tends to be slower in converging towards the expected target allocation proportion. The link function based design achieves the highest skewness of patient allocation to the best treatment arm and thus ethically is the best design. Other comparative merits of the proposed designs have been highlighted and their preferred areas of application are discussed. It is concluded that the proposed CARA designs can be considered as suitable alternatives to the traditional balanced randomization designs in survival trials in terms of the power of the Wald test, provided that response data are available during the recruitment phase of the trial to enable adaptations to the designs. Moreover, the proposed designs enable more patients to get treated with the better treatment during the trial thus making the designs more ethically attractive to the patients. An existing clinical trial has been redesigned using these methods.

Keywords: censored response, Cox regression, efficiency, ethics, optimal allocation, power, variability

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Authors: Mangala. Sadasivan, Mary Hughes, Bryan Kelly

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Medical Education must focus on bridging the gap between teaching and learning when training pre-clinical year students in skills needed to keep up with medical knowledge and to meet the demands of health care in the future. The authors were interested in showing that a 3-S Model (building strength, developing stamina, and increasing speed) using a bridged curriculum design helps connect teaching and learning and improves students’ retention of basic science and clinical knowledge. The authors designed three learning modules using the 3-S Model within a systems course in a pre-clerkship medical curriculum. Each module focused on a bridge (concept map) designed by the instructor for specific content delivered to students in the course. This with-in-subjects design study included 304 registered MSU osteopathic medical students (3 campuses) ranked by quintile based on previous coursework. The instructors used the bridge to create self-directed learning exercises (building strength) to help students master basic science content. Students were video coached on how to complete assignments, and given pre-tests and post-tests designed to give them control to assess and identify gaps in learning and strengthen connections. The instructor who designed the modules also used video lectures to help students master clinical concepts and link them (building stamina) to previously learned material connected to the bridge. Boardstyle practice questions relevant to the modules were used to help students improve access (increasing speed) to stored content. Unit Examinations covering the content within modules and materials covered by other instructors teaching within the units served as outcome measures in this study. This data was then compared to each student’s performance on a final comprehensive exam and their COMLEX medical board examinations taken some time after the course. The authors used mean comparisons to evaluate students’ performances on module items (using 3-S Model) to non-module items on unit exams, final course exam and COMLEX medical board examination. The data shows that on average, students performed significantly better on module items compared to non-module items on exams 1 and 2. The module 3 exam was canceled due to a university shut down. The difference in mean scores (module verses non-module) items disappeared on the final comprehensive exam which was rescheduled once the university resumed session. Based on Quintile designation, the mean scores were higher for module items than non-module items and the difference in scores between items for Quintiles 1 and 2 were significantly better on exam 1 and the gap widened for all Quintile groups on exam 2 and disappeared in exam 3. Based on COMLEX performance, all students on average as a group, whether they Passed or Failed, performed better on Module items than non-module items in all three exams. The gap between scores of module items for students who passed COMLEX to those who failed was greater on Exam 1 (14.3) than on Exam 2 (7.5) and Exam 3 (10.2). Data shows the 3-S Model using a bridge effectively connects teaching and learning

Keywords: bridging gap, medical education, teaching and learning, model of learning

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Authors: Getachew Belay Kassahun

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Background: Aspartate aminotransferase to Platelet Ratio Index (APRI) currently becomes a biomarker for screening liver fibrosis since liver biopsy procedure is invasive and variation in pathological interpretation. Clinical Laboratory Standard Institute recommends establishing age, sex and environment specific reference interval for biomarkers in a homogenous population. The current study was aimed to derive community based reference interval of APRI aged between 12 and 60 years old in Mekelle city Tigrai, Northern Ethiopia. Method: Six hundred eighty eight study participants were collected from three districts in Mekelle city. The 3 districts were selected through random sampling technique and sample size to kebelles (small administration) were distributed proportional to household number in each district. Lottery method was used at household level if more than 2 study participants to each age partition were found. A community based cross sectional in a total of 534 study participants, 264 male and 270 females, were included in the final laboratory and data analysis but around 154 study participants were excluded through exclusion criteria. Aspartate aminotransferase was analyzed through Biosystem chemistry analyzer and Sysmix machine was used to analyze platelet. Man Whitney U test non parametric stastical tool was used to appreciate stastical difference among gender after excluding the outliers through Box and Whisker. Result: The study appreciated stastical difference among gender for APRI reference interval. The combined, male and female reference interval in the current study was 0.098-0.390, 0.133-0.428 and 0.090-0.319 respectively. The upper and lower reference interval of males was higher than females in all age partition and there was no stastical difference (p-value (<0.05)) between age partition. Conclusion: The current study showed using sex specific reference interval is significant to APRI biomarker in clinical practice for result interpretation.

Keywords: reference interval, aspartate aminotransferase to platelet ratio Index, Ethiopia, tigray

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

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

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

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Authors: Charlotte K. Lee, Henrique R. N. Aguiar, Ralph Smith, James Baldock, Sam Botchey

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Background: Femoral neck stress fractures (FNSF) are uncommon, making up 1 to 7.2% of stress fractures in healthy subjects. FNSFs are prevalent in young women, military recruits, endurance athletes, and individuals with energy deficiency syndrome or female athlete triad. Presentation is often non-specific and is often misdiagnosed following the initial examination. There is limited research addressing the return–to–activity time after FNSF. Previous studies have demonstrated prognostic time predictions based on various imaging techniques. Here, (1) OxSport clinic FNSF practice standards are retrospectively reviewed, (2) FNSF cohort demographics are examined, (3) Regression models were used to predict return–to–activity prognosis and consequently determine bone stress risk factors. Methods: Patients with a diagnosis of FNSF attending Oxsport clinic between 01/06/2020 and 01/01/2020 were selected from the Rheumatology Assessment Database Innovation in Oxford (RhADiOn) and OxSport Stress Fracture Database (n = 14). (1) Clinical practice was audited against five criteria based on local and National Institute for Health Care Excellence guidance, with a 100% standard. (2) Demographics of the FNSF cohort were examined with Student’s T-Test. (3) Lastly, linear regression and Random Forest regression models were used on this patient cohort to predict return–to–activity time. Consequently, an analysis of feature importance was conducted after fitting each model. Results: OxSport clinical practice met standard (100%) in 3/5 criteria. The criteria not met were patient waiting times and documentation of all bone stress risk factors. Importantly, analysis of patient demographics showed that of the population with complete bone stress risk factor assessments, 53% were positive for modifiable bone stress risk factors. Lastly, linear regression analysis was utilized to identify demographic factors that predicted return–to–activity time [R2 = 79.172%; average error 0.226]. This analysis identified four key variables that predicted return-to-activity time: vitamin D level, total hip DEXA T value, femoral neck DEXA T value, and history of an eating disorder/disordered eating. Furthermore, random forest regression models were employed for this task [R2 = 97.805%; average error 0.024]. Analysis of the importance of each feature again identified a set of 4 variables, 3 of which matched with the linear regression analysis (vitamin D level, total hip DEXA T value, and femoral neck DEXA T value) and the fourth: age. Conclusion: OxSport clinical practice could be improved by more comprehensively evaluating bone stress risk factors. The importance of this evaluation is demonstrated by the population found positive for these risk factors. Using this cohort, potential bone stress risk factors that significantly impacted return-to-activity prognosis were predicted using regression models.

Keywords: eating disorder, bone stress risk factor, femoral neck stress fracture, vitamin D

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Authors: Sakshi Chopra, Harsimarpreet Kaur, Ashima Nehra

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Objectives: Malingering is fabricating or exaggerating the symptoms of mental or physical disorders for a variety of secondary gains or motives, which may include financial compensation; avoiding work; getting lighter criminal sentences; or simply to attract attention or sympathy. Malingering is different from somatization disorder and factitious disorder. The prevalence of malingering is unknown and difficult to determine. In an estimated study in forensic population, it can reach up to 17% cases. But the accuracy of such estimates is questionable as successful malingerers are not detected and thus, not included. Methods: The case study of a 58 years old, right handed, graduate, pre-morbidly working in a national company with reported history of stroke leading to head injury; cerebral infarction/facial palsy and dementia. He was referred for disability certification so that his job position can be transferred to his son as he could not work anymore. A series of Neuropsychological tests were administered. Results: With a mental age of < 2.5 years; social adaptive functioning was overall < 20 showing profound Mental Retardation, less than 1 year social age in abilities of self-help, eating, dressing, locomotion, occupation, communication, self-direction, and socialization; severely impaired verbal and performance ability, 96% impairment in Activities of Daily Living, with an indication of very severe depression. With inconsistent and fluctuating medical findings and problem descriptions to different health professionals forming the board for his disability, it was concluded that this patient was malingering. Conclusions: Even though it can be easily defined, malingering can be very challenging to diagnosis. Cases of malingering impose a substantial economic burden on the health care system and false attribution of malingering imposes a substantial burden of suffering on a significant proportion of the patient population. Timely, tactful diagnosis and management can help ease this patient burden on the healthcare system. Malingering can be detected by only trained mental health professionals in the clinical setting.

Keywords: disability, India, malingering, neuropsychological assessment

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Authors: Sadaf Moeez, Madiha Khalid, Zoya Khalid, Sania Shaheen, Sumbul Khalid

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Background: Inter-individual variation in response to metformin, which has been considered as a first line therapy for T2DM treatment is considerable. In the current study, it was aimed to investigate the impact of two genetic variants Leu125Phe (rs77474263) and Gly64Asp (rs77630697) in gene SLC47A1 on the clinical efficacy of metformin in T2DM Pakistani patients. Methods: The study included 800 T2DM patients (400 metformin responders and 400 metformin non-responders) along with 400 ethnically matched healthy individuals. The genotypes were determined by allele-specific polymerase chain reaction. In-silico analysis was done to confirm the effect of the two SNPs on the structure of genes. Association was statistically determined using SPSS software. Results: Minor allele frequency for rs77474263 and rs77630697 was 0.13 and 0.12. For SLC47A1 rs77474263 the homozygotes of one mutant allele ‘T’ (CT) of rs77474263 variant were fewer in metformin responders than metformin non-responders (29.2% vs. 35.5 %). Likewise, the efficacy was further reduced (7.2% vs. 4.0 %) in homozygotes of two copies of ‘T’ allele (TT). Remarkably, T2DM cases with two copies of allele ‘C’ (CC) had 2.11 times more probability to respond towards metformin monotherapy. For SLC47A1 rs77630697 the homozygotes of one mutant allele ‘A’ (GA) of rs77630697 variant were fewer in metformin responders than metformin non-responders (33.5% vs. 43.0 %). Likewise, the efficacy was further reduced (8.5% vs. 4.5%) in homozygotes of two copies of ‘A’ allele (AA). Remarkably, T2DM cases with two copies of allele ‘G’ (GG) had 2.41 times more probability to respond towards metformin monotherapy. In-silico analysis revealed that these two variants affect the structure and stability of their corresponding proteins. Conclusion: The present data suggest that SLC47A1 Leu125Phe (rs77474263) and Gly64Asp (rs77630697) polymorphisms were associated with the therapeutic response of metformin in T2DM patients of Pakistan.

Keywords: diabetes, T2DM, SLC47A1, Pakistan, polymorphism

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Authors: T. Yasmin, M. A. Farrelly, B. C. Rogers

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Urban water governance in developing countries faces numerous challenges arising from uncontrolled urban population expansion, water pollution, greater economic push and more recently, climate change impact while undergoing transitioning towards a sustainable system. Sustainability transition requires developing adaptive capacities of the socio-ecological and socio-technical system to be able to deal with complexity. Adaptive capacities deliver strategies to connect individuals, organizations, agencies and institutions at multiple levels for dealing with such complexity. Understanding the level of adaptive capacities for sustainability transformation thus has gained significant research attention within developed countries, much less so in developing countries. Filling this gap, this article develops a conceptual framework for analysing the level of adaptive capacities (if any) within a developing context. This framework then applied to the chronological development of urban water governance strategies in Bangladesh for almost two centuries. The chronological analysis of governance interventions has revealed that crisis (public health, food and natural hazards) became the opportunities and thus opened the windows for experimentation and learning to occur as a deviation from traditional practices. Self-organization and networks thus created the platform for development or disruptions to occur for creating change. Leadership (internal or external) is important for nurturing and upscaling theses development or disruptions towards guiding policy vision and targets as well as championing ground implementation. In the case of Bangladesh, the leadership from the international and national aid organizations and targets have always lead the development whereas more often social capital tools (trust, power relations, cultural norms) act as disruptions. Historically, this has been evident in the development pathways of urban water governance in Bangladesh. Overall this research has shown some level of adaptive capacities is growing for sustainable urban growth in big cities, nevertheless unclear regarding the growth in medium and small cities context.

Keywords: adaptive capacity, Bangladesh, sustainability transformation, water governance

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Authors: Faezeh Jahanpour, Shahin Dezhdar, Saeedeh Firouz Bakht, Afshin Ostovar

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Objective: The hospitalized premature babies often undergo various painful procedures such as venous sampling. The Kangaroo mother care (KMC) method is one of the pain reduction methods, but as mother’s presence is not always possible, this research was done to compare the effect of swaddling and KMC method on venous sampling pain on premature neonates. Methods: In this randomized clinical trial 90 premature infants selected and randomly alocated into three groups; Group A (swaddling), Group B (the kangaroo care), and group C (the control). From 10 minutes before blood sampling to 2 minutes after that in group A, the infant was wrapped in a thin sheet, and in group B, the infant was under Kangaroo care. In all three groups, the heart rate and arterial oxygen saturation in time intervals of 30 seconds before, during, 30-60-90, and 120 seconds after sampling were measured and recorded. The infant’s face was video recorded since sampling till 2 minutes and the videos were checked by a researcher who was unaware of the kind of intervention and the pain assessment tools for infants (PIPP) for time intervals of 30 seconds were completed. Data analyzed by t-test, Q square, Repeated Measure ANOVA, Kruskal-Wallis, Post-hoc and Bonferroni test. Results: Findings revealed that the pain was reduced to a great extent in swaddling and kangaroo method compared to that in control group. But there was not a significant difference between kangaroo and swaddling care method (P ≥ 0.05). In addition, the findings showed that the heart rate and arterial oxygen saturation was low and stable in swaddling and Kangaroo care method and returned to base status faster, whereas, the changes were severe in control group and did not return to base status even after 120 seconds. Discussion: The results of this study showed that there was not a meaningful difference between swaddling and kangaroo care method on physiological indexes and pain in infants. Therefore, swaddling method can be a good substitute for kangaroo care method in this regard.

Keywords: Kangaroo mother care, neonate, pain, premature, swaddling, venipuncture,

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Authors: Godwin Dennison, C. E. Boulind, O. Gould, B. de Lacy Costello, J. Allison, P. White, P. Ewings, A. Wicaksono, N. J. Curtis, A. Pullyblank, D. Jayne, J. A. Covington, N. Ratcliffe, N. K. Francis

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Background: Colorectal symptoms are common but only infrequently represent serious pathology, including colorectal cancer (CRC). A large number of invasive tests are presently performed for reassurance. We investigated the feasibility of urinary volatile organic compound (VOC) testing as a potential triage tool in patients fast-tracked for assessment for possible CRC. Methods: A prospective, multi-centre, observational feasibility study was performed across three sites. Patients referred on NHS fast-track pathways for potential CRC provided a urine sample which underwent Gas Chromatography Mass Spectrometry (GC-MS), Field Asymmetric Ion Mobility Spectrometry (FAIMS) and Selected Ion Flow Tube Mass Spectrometry (SIFT-MS) analysis. Patients underwent colonoscopy and/or CT colonography and were grouped as either CRC, adenomatous polyp(s), or controls to explore the diagnostic accuracy of VOC output data supported by an artificial neural network (ANN) model. Results: 558 patients participated with 23 (4.1%) CRC diagnosed. 59% of colonoscopies and 86% of CT colonographies showed no abnormalities. Urinary VOC testing was feasible, acceptable to patients, and applicable within the clinical fast track pathway. GC-MS showed the highest clinical utility for CRC and polyp detection vs. controls (sensitivity=0.878, specificity=0.882, AUROC=0.884). Conclusion: Urinary VOC testing and analysis are feasible within NHS fast-track CRC pathways. Clinically meaningful differences between patients with cancer, polyps, or no pathology were identified therefore suggesting VOC analysis may have future utility as a triage tool. Acknowledgment: Funding: NIHR Research for Patient Benefit grant (ref: PB-PG-0416-20022).

Keywords: colorectal cancer, volatile organic compound, gas chromatography mass spectrometry, field asymmetric ion mobility spectrometry, selected ion flow tube mass spectrometry

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Authors: Prasamsha Panta, Da Yeon Kim, Ja Yong Jang, Min Jae Kim, Jae Ho Kim, Moon Suk Kim

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Introduction: Among the many anticancer drugs used clinically, doxorubicin (Dox), was one of widely used drugs to treat many types of solid tumors such as liver, colon, breast, or lung. Intratumoral injection of chemotherapeutic agents is a potentially more effective alternative to systemic administration because direct delivery of the anticancer drug to the target may improve both the stability and efficacy of anticancer drugs. Injectable in situ-forming gels have attracted considerable attention because they can achieve site specific drug delivery, long term action periods, and improved patient compliance. Objective: Objective of present study is to confirm clinical benefit of intratumoral chemotherapy using injectable in situ-forming poly(ethylene glycol)-b-polycaprolactone diblock copolymer (MP) and Dox with increase in efficacy and reducing the toxicity in patients with cancer diseases. Methods and methodology: We prepared biodegradable MP hydrogel and measured viscosity for the evaluation of thermo-sensitive property. In vivo antitumor activity was performed with normal saline, MP only, single free Dox, repeat free Dox, and Dox-loaded MP gel. The remaining amount of Dox drug was measured using HPLC after the mouse was sacrified. For cytotoxicity studies WST-1 assay was performed. Histological analysis was done with H&E and TUNEL processes respectively. Results: The works in this experiment showed that Dox-loaded MP have biodegradable drug depot property. Dox-loaded MP gels showed remarkable in vitro cytotoxicity activities against cancer cells. Finally, this work indicates that injection of Dox-loaded MP allowed Dox to act effectively in the tumor and induced long-lasting supression of tumor growth. Conclusion: This work has examined the potential clinical utility of intratumorally injected Dox-loaded MP gel, which shows significant effect of higher local Dox retention compared with systemically administered Dox.

Keywords: injectable in-situ forming hydrogel, anticancer, doxorubicin, intratumoral injection

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Authors: M. Testa, L. Peotta, S. Giusiano, B. Lazzolino, U. Manera, A. Canosa, M. Grassano, F. Palumbo, A. Bombaci, S. Cabras, F. Di Pede, L. Solero, E. Matteoni, C. Moglia, A. Calvo, A. Chio

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Amyotrophic Lateral Sclerosis (ALS) is a neurodegenerative disease of adulthood, which primarily affects the central nervous system and is characterized by progressive bilateral degeneration of motor neurons. The degeneration processes in ALS extend far beyond the neurons of the motor system, and affects cognition, behaviour and language. To outline the prevalence of language deficits in an ALS cohort and explore their profile along with demographic and neuropsychological data. A full neuropsychological battery and language assessment was administered to 56 ALS patients. Neuropsychological assessment included tests of executive functioning, verbal fluency, social cognition and memory. Language was assessed using tests for verbal comprehension, production and pragmatics. Patients were cognitively classified following the Revised Consensus Criteria and divided in three groups showing different levels of language deficits: group 1 - no language deficit; group 2 - one language deficit; group 3 - two or more language deficits. Chi-square for independence and non-parametric measures to compare groups were applied. Nearly half of ALS-CN patients (48%) reported one language test under the clinical cut-off, and only 13% of patents classified as ALS-CI showed no language deficits, while the rest 87% of ALS-CI reported two or more language deficits. ALS-BI and ALS-CBI cases all reported two or more language deficits. Deficits in production and in comprehension appeared more frequent in ALS-CI patients (p=0.011, p=0.003 respectively), with a higher percentage of comprehension deficits (83%). Nearly all ALS-CI reported at least one deficit in pragmatic abilities (96%) and all ALS-BI and ALS-CBI patients showed pragmatic deficits. Males showed higher percentage of pragmatic deficits (97%, p=0.007). No significant differences in language deficits have been found between bulbar and spinal onset. Months from onset and level of impairment at testing (ALS-FRS total score) were not significantly different between levels and type of language impairment. Age and education were significantly higher for cases showing no deficits in comprehension and pragmatics and in the group showing no language deficits. Comparing performances at neuropsychological tests among the three levels of language deficits, no significant differences in neuropsychological performances were found between group 1 and 2; compared to group 1, group 3 appeared to decay specifically on executive testing, verbal/visuospatial learning, and social cognition. Compared to group 2, group 3 showed worse performances specifically in tests of working memory and attention. Language deficits have found to be spread in our sample, encompassing verbal comprehension, production and pragmatics. Our study reveals that also cognitive intact patients (ALS-CN) showed at least one language deficit in 48% of cases. Pragmatic domain is the most compromised (84% of the total sample), present in nearly all ALS-CI (96%), likely due to the influence of executive impairment. Lower age and higher education seem to preserve comprehension, pragmatics and presence of language deficits. Finally, executive functions, verbal/visuospatial learning and social cognition differentiate the group with no language deficits from the group with a clinical language impairment (group 3), while attention and working memory differentiate the group with one language deficit from the clinical impaired group.

Keywords: amyotrophic lateral sclerosis, language assessment, neuropsychological assessment, language deficit

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Authors: Shelley Y. Hawkins

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Introduction/Background: As technology has grown exponentially in healthcare, nurse educators must prepare Advanced Practice Registered Nurse (APRN) graduates with the knowledge and skills in information systems/technology to support and improve patient care and health care systems. APRN’s are expected to lead in caring for populations who lack accessibility and availability through the use of technology, specifically telehealth. The capacity to effectively and efficiently use technology in patient care delivery is clearly delineated in the American Association of Colleges of Nursing (AACN) Doctor of Nursing Practice (DNP) and Master of Science in Nursing (MSN) Essentials. However, APRN’s have minimal, or no, exposure to formalized telehealth education and lack necessary technical skills needed to incorporate telehealth into their patient care. APRN’s must successfully master the technology using telehealth/telemedicine, electronic health records, health information technology, and clinical decision support systems to advance health. Furthermore, APRN’s must be prepared to lead the coordination and collaboration with other healthcare providers in their use and application. Aim/Goal/Purpose: The purpose of this presentation is to establish and operationalize telehealth-focused educational partnerships between one University School of Nursing and two health care systems in order to enhance the preparation of APRN NP students for practice, teaching, and/or scholarly endeavors. Methods: The proposed project was initially presented by the project director to selected multidisciplinary stakeholders including leadership, home telehealth personnel, primary care providers, and decision support systems within two major health care systems to garner their support for acceptance and implementation. Concurrently, backing was obtained from key university-affiliated colleagues including the Director of Simulation and Innovative Learning Lab and Coordinator of the Health Care Informatics Program. Technology experts skilled in design and production in web applications and electronic modules were secured from two local based technology companies. Results: Two telehealth-focused APRN Program academic/practice partnerships have been established. Students have opportunities to engage in clinically based telehealth experiences focused on: (1) providing patient care while incorporating various technology with a specific emphasis on telehealth; (2) conducting research and/or evidence-based practice projects in order to further develop the scientific foundation regarding incorporation of telehealth with patient care; and (3) participating in the production of patient-level educational materials related to specific topical areas. Conclusions: Evidence-based APRN student telehealth clinical experiences will assist in preparing graduates who can effectively incorporate telehealth into their clinical practice. Greater access for diverse populations will be available as a result of the telehealth service model as well as better care and better outcomes at lower costs. Furthermore, APRN’s will provide the necessary leadership and coordination through interprofessional practice by transforming health care through new innovative care models using information systems and technology.

Keywords: academic/practice partnerships, advanced practice nursing, nursing education, telehealth

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Authors: Leonore Robieux, Franck Zenasni, Marc Pocard, Clarisse Eveno

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Empirical data in health psychology studies show the necessity to consider the doctor-patient communication and its positive impact on outcomes such as patients’ satisfaction, treatment adherence, physical and psychological wellbeing. In this line, the present research aims to define the role and determinants of an effective doctor–patient communication during the treatment of patients with serious illness (peritoneal carcinomatosis). We carried out a prospective longitudinal study including patients treated for peritoneal carcinomatosis of various origins. From November 2016, to date, data were collected using validated questionnaires at two times of evaluation: one month before the surgery (T0) and one month after (T1). Thus, patients reported their (a) anxiety and depression levels, (b) standardized and individualized quality of life and (c) how they perceived communication, attitude and empathy of the surgeon. 105 volunteer patients (Mean age = 58.18 years, SD = 10.24, 62.2% female) participated to the study. PC arose from rare diseases (14%), colorectal (38%), eso-gastric (24%) and ovarian (8%) cancer. Three groups are defined according to the severity of their pathology and the treatment offered to them: (1) important surgical treatment with the goal of healing (53%), (2) repeated palliative surgical treatment (17%), and (3) the patients recused for surgical treatment, only palliative approach (30%). Results are presented according to Baron and Kenny recommendations. The regressions analyses show that only depression and anxiety are sensitive to the communication and empathy of surgeon. The main results show that a good communication and high level of empathy at T0 and T1 limit depression and anxiety of the patients in T1. Results also indicate that the severity of the disease modulates this positive impact of communication: better is the communication the less are the level of depression and anxiety of the patients. This effect is higher for patients treated for the more severe disease. These results confirm that, even in the case severe disease a good communication between patient and physician remains a significant factor in promoting the well-being of patients. More specific training need to be developed to promote empathic care.

Keywords: clinical empathy, determinants, healthcare, psychological wellbeing

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Authors: Hee-Young Song

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Background and objectives: In 2011, the Global Initiative for Chronic Obstructive Lung Disease (GOLD) recommendations proposed a multidimensional assessment of patients’ conditions that included both functional parameters and patient-reported outcomes, with the aim to provide a comprehensive assessment of the disease, thus meeting both the needs of the patient and the role of the physician. However, few studies have evaluated patient-reported outcomes as well as objective functional assessments among individuals with chronic obstructive pulmonary disease (COPD) in clinical practice in Korea. This study was undertaken to explore the relationship between functional status assessed by the 6-minute walking distance (MWD) test and subjective health status reported by stable patients with COPD residing in community. Methods: A cross-sectional descriptive study was conducted with 118 stable COPD patients aged 69.4 years old and selected by a convenient sampling from an outpatient department of pulmonology in a tertiaryhospitals. The 6-MWD test was conducted according to standardized instructions. Participants also completed a constructed questionnaire including general characteristics, smoking history, dyspnea by modified medical research council (mMRC) scale, and health status by COPD assessment test (CAT). Anthropometric measurements were performed for body mass index (BMI). Medical records were reviewed to obtain disease-related characteristics including duration of the disease and forced expiratory volume in 1 second (FEV1). Data were analyzed using PASW statistics 20.0. Results: Mean FEV1% of participants was 63.51% and mean 6-MWD and CAT scores were 297.54m and 17.7, respectively. The 6-MWD and CAT showed significant negative correlations (r= -.280, p=.002); FEV1 and CAT did as well correlations (r= -.347, p < .001). Conclusions: Findings suggest that the better functional status an individual with COPD has, the better subjective health status is, and provide the support for using patient-reported outcomes along with functional parameters to facilitate comprehensive assessment of COPD patients in real clinical practices.

Keywords: chronic obstructive pulmonary disease, COPD assessment test, functional status, patient-reported outcomes

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Authors: Rania Hanafi Mahmoud Said, Rasha Mohamed Taha

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Background: A recent study has explored the potential of an approach to treating infected root canals using a combination of Mineral Trioxide Aggregate (MTA) and Tetracycline-loaded Nanochitosan. Material and methods: Forty dogs were included in the study, with infected periapical areas induced by leaving access openings in their teeth for four months. Bacteriological samples from the infected root canals were collected and managed anaerobically to identify and count the different microorganisms present. The most common microorganisms detected were Prevotella oris, Fusobacterium nucleatum, Streptococcus viridans, Enterococcus faecalis, Clostridium subterminale, Porphyromonas gingivalis, and Peptostreptococcus anaerobius. The dogs were divided into four groups based on the sealant used to treat the infected periapical areas: Group I: Negative control (no treatment) Group II: Positive control (MTA only) Group III: MTA + tetracycline Group IV: MTA + tetracycline loaded on nanochitosan Results: Periapical areas in Group IV showed significantly more bone healing than those in Groups I, II, and III. The newly formed bone was evaluated radiographically, histologically, and immunohistochemically using Osteopontin (OSP) antibodies. Data collected was statistically analysed using SPSS software at a 0.05 significance level. Conclusion: The study concluded that the combined use of Tetracycline-loaded Nanochitosan and MTA presents a promising approach for the treatment of infected root canals. The potent antimicrobial activity of Tetracycline-loaded Nanochitosan, along with the biocompatibility and desirable properties of MTA, may synergistically contribute to improved clinical outcomes in endodontic therapy. This study has important implications for the clinical management of infected root canals. The combination of Tetracycline-loaded Nanochitosan and MTA could provide a more effective and efficient means of treating these challenging cases. Further research is needed to confirm these findings in humans and to optimize the treatment protocol.

Keywords: mineral trioxide aggregate, tetracycline-loaded nanochitosan, periapical infection, osteopontine

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Authors: Jonas Sanon

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The valorization of research is becoming a transversal instrument linking different sectors (academic, public and industrial). The practice of valorization seems to impact innovation techniques within companies where, there is often the implementation of industrial conventions of training through research (CIFRE), continuous training programs for employees, collaborations and partnerships around joint research and R&D laboratories focused on the needs of companies to improve or develop more efficient innovations. Furthermore, many public initiatives to support innovation and technology transfer have been developed at the international, European and national levels, with significant budget allocations. Thus, in the context of this work, we tried to analyze the way in which research transfer structures are evaluated within the Saclay ecosystem. In fact, the University-Paris-Saclay is one of the best French universities; it is made up of 10 university components, more than 275 laboratories and is in partnership with the largest French research centers This work mainly focused on how evaluations affected research transfer structures, how evaluations were conducted, and what the managers of research transfer structures thought about assessments. Thus, with the aid of the conducted interviews, it appears that the evaluations do not have a significant impact on the qualitative aspect of research and innovation, but is rather present a directive aspect to allow the structures to benefit or not from the financial resources to develop certain research work, sometimes directed and influenced by the market, some researchers might try to accentuate their research and experimentation work on themes that are not necessarily their areas of interest, but just to comply with the calls for proposed thematic projects. The field studies also outline the primary indicators used to assess the effectiveness of valorization structures as "the number of start-ups generated, the license agreements signed, the structure's patent portfolio, and the innovations of items developed from public research.". Finally, after mapping the actors, it became clear that the ecosystem of the University of Paris-Saclay benefits from a richness allowing it to better value its research in relation to the three categories of actors it has (internal, external and transversal), united and linked by a relationship of proximity of sharing and endowed with a real opportunity to innovate openly.

Keywords: research valorization, technology transfer, innovation, evaluation, impacts and performances, innovation policy

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Authors: Kevin Syam, Devendra K. Chauhan, Mandeep Singh Dhillon

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Background: The posterior horn of medial meniscus (PHMM) is a secondary stabilizer against anterior translation of tibia. Cadaveric studies have revealed increased strain on the ACL graft and greater instrumented laxity in Posterior horn deficient knees. Clinical studies have shown higher prevalence of radiological OA after ACL reconstruction combined with menisectomy. However, functional outcomes in ACL reconstructed knee in the absence of Posterior horn is less discussed, and specific role of posterior horn is ill-documented. This study evaluated functional and radiological outcomes in posterior horn preserved and posterior horn sacrificed ACL reconstructed knees. Materials: Of the 457 patients who had ACL reconstruction done over a 6 year period, 77 cases with minimum follow up of 18 months were included in the study after strict exclusion criteria (associated lateral meniscus injury, other ligamentous injuries, significant cartilage degeneration, repeat injury and contralateral knee injuries were excluded). 41 patients with intact menisci were compared with 36 patients with absent posterior horn of medial meniscus. Radiological and clinical tests for instability were conducted, and knees were evaluated using subjective International Knee Documentation Committee (IKDC) score and the Orthopadische Arbeitsgruppe Knie score (OAK). Results: We found a trend towards significantly better overall outcome (OAK) in cases with intact PHMM at average follow-up of 43.03 months (p value 0.082). Cases with intact PHMM had significantly better objective stability (p value 0.004). No significant differences were noted in the subjective IKDC score (p value 0.526) and the functional OAK outcome (category D) (p value 0.363). More cases with absent posterior horn had evidence of radiological OA (p value 0.022) even at mid-term follow-up. Conclusion: Even though the overall OAK and subjective IKDC scores did not show significant difference between the two subsets, the poorer outcomes in terms of objective stability and radiological OA noted in the absence of PHMM, indicates the importance of preserving this important part of the meniscus.

Keywords: ACL, functional outcome, knee, posterior of medial meniscus

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Authors: Lorico D. S. Lapitan Jr., Yihan Xu, Yuan Guo, Dejian Zhou

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The ability of ultrasensitive detection of specific genes and discrimination of single nucleotide polymorphisms is important for clinical diagnosis and biomedical research. Herein, we report the development of a new ultrasensitive approach for label-free DNA detection using magnetic nanoparticle (MNP) assisted rapid target capture/separation in combination with signal amplification using poly-enzyme tagged polymer nanobead. The sensor uses an MNP linked capture DNA and a biotin modified signal DNA to sandwich bind the target followed by ligation to provide high single-nucleotide polymorphism discrimination. Only the presence of a perfect match target DNA yields a covalent linkage between the capture and signal DNAs for subsequent conjugation of a neutravidin-modified horseradish peroxidase (HRP) enzyme through the strong biotin-nuetravidin interaction. This converts each captured DNA target into an HRP which can convert millions of copies of a non-fluorescent substrate (amplex red) to a highly fluorescent product (resorufin), for great signal amplification. The use of polymer nanobead each tagged with thousands of copies of HRPs as the signal amplifier greatly improves the signal amplification power, leading to greatly improved sensitivity. We show our biosensing approach can specifically detect an unlabeled DNA target down to 10 aM with a wide dynamic range of 5 orders of magnitude (from 0.001 fM to 100.0 fM). Furthermore, our approach has a high discrimination between a perfectly matched gene and its cancer-related single-base mismatch targets (SNPs): It can positively detect the perfect match DNA target even in the presence of 100 fold excess of co-existing SNPs. This sensing approach also works robustly in clinical relevant media (e.g. 10% human serum) and gives almost the same SNP discrimination ratio as that in clean buffers. Therefore, this ultrasensitive SNP biosensor appears to be well-suited for potential diagnostic applications of genetic diseases.

Keywords: DNA detection, polymer beads, signal amplification, single nucleotide polymorphisms

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Authors: Suliman Al-Fayoumi, Sherri Amberg, Huafeng Zhou, Jack W. Singer, James P. Dean

Abstract:

Pacritinib is an oral kinase inhibitor with specificity for JAK2, FLT3, IRAK1, and CSF1R. In clinical studies, pacritinib was well tolerated with clinical activity in patients with myelofibrosis. The most frequent adverse events (AEs) observed with pacritinib are gastrointestinal (diarrhea, nausea, and vomiting; mostly grade 1-2 in severity) and typically resolve within 2 weeks. A human ADME mass balance study demonstrated that pacritinib is predominantly cleared via hepatic metabolism and biliary excretion (>85% of administered dose). The major hepatic metabolite identified, M1, is not thought to materially contribute to the pharmacological activity of pacritinib. Hepatic diseases are known to impair hepatic blood flow, drug-metabolizing enzymes, and biliary transport systems and may affect drug absorption, disposition, efficacy, and toxicity. This phase 1 study evaluated the pharmacokinetics (PK) and safety of pacritinib and the M1 metabolite in study subjects with mild, moderate, or severe hepatic impairment (HI) and matched healthy subjects with normal liver function to determine if pacritinib dosage adjustments are necessary for patients with varying degrees of hepatic insufficiency. Study participants (aged 18-85 y) were enrolled into 4 groups based on their degree of HI as defined by Child-Pugh Clinical Assessment Score: mild (n=8), moderate (n=8), severe (n=4), and healthy volunteers (n=8) matched for age, BMI, and sex. Individuals with concomitant renal dysfunction or progressive liver disease were excluded. A single 400 mg dose of pacritinib was administered to all participants. Blood samples were obtained for PK evaluation predose and at multiple time points postdose through 168 h. Key PK parameters evaluated included maximum plasma concentration (Cmax), time to Cmax (Tmax), area under the plasma concentration time curve (AUC) from hour zero to last measurable concentration (AUC0-t), AUC extrapolated to infinity (AUC0-∞), and apparent terminal elimination half-life (t1/2). Following treatment, pacritinib was quantifiable for all study participants at 1 h through 168 h postdose. Systemic pacritinib exposure was similar between healthy volunteers and individuals with mild HI. However, there was a significant difference between those with moderate and severe HI and healthy volunteers with respect to peak concentration (Cmax) and plasma exposure (AUC0-t, AUC0-∞). Mean Cmax decreased by 47% and 57% respectively in participants with moderate and severe HI vs matched healthy volunteers. Similarly, mean AUC0-t decreased by 36% and 45% and mean AUC0-∞ decreased by 46% and 48%, respectively in individuals with moderate and severe HI vs healthy volunteers. Mean t1/2 ranged from 51.5 to 74.9 h across all groups. The variability on exposure ranged from 17.8% to 51.8% across all groups. Systemic exposure of M1 was also significantly decreased in study participants with moderate or severe HI vs. healthy participants and individuals with mild HI. These changes were not significantly dissimilar from the inter-patient variability in these parameters observed in healthy volunteers. All AEs were grade 1-2 in severity. Diarrhea and headache were the only AEs reported in >1 participant (n=4 each). Based on these observations, it is unlikely that dosage adjustments would be warranted in patients with mild, moderate, or severe HI treated with pacritinib.

Keywords: pacritinib, myelofibrosis, hepatic impairment, pharmacokinetics

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