Search results for: reduction in potential medical errors due to elimination of transcription errors

Authors: David J. Foran, Nhan Do, Samuel Ajjarapu, Wenjin Chen, Tahsin Kurc, Joel H. Saltz

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The large-scale data and computational requirements of investigators throughout the clinical and research communities demand an informatics infrastructure that supports both existing and new investigative and translational projects in a robust, secure environment. In some subspecialties of medicine and research, the capacity to generate data has outpaced the methods and technology used to aggregate, organize, access, and reliably retrieve this information. Leading health care centers now recognize the utility of establishing an enterprise-wide, clinical data warehouse. The primary benefits that can be realized through such efforts include cost savings, efficient tracking of outcomes, advanced clinical decision support, improved prognostic accuracy, and more reliable clinical trials matching. The overarching objective of the work presented here is the development and implementation of a flexible Intelligent Retrieval and Interrogation System (IRIS) that exploits the combined use of computational imaging, genomics, and data-mining capabilities to facilitate clinical assessments and translational research in oncology. The proposed System includes a multi-modal, Clinical & Research Data Warehouse (CRDW) that is tightly integrated with a suite of computational and machine-learning tools to provide insight into the underlying tumor characteristics that are not be apparent by human inspection alone. A key distinguishing feature of the System is a configurable Extract, Transform and Load (ETL) interface that enables it to adapt to different clinical and research data environments. This project is motivated by the growing emphasis on establishing Learning Health Systems in which cyclical hypothesis generation and evidence evaluation become integral to improving the quality of patient care. To facilitate iterative prototyping and optimization of the algorithms and workflows for the System, the team has already implemented a fully functional Warehouse that can reliably aggregate information originating from multiple data sources including EHR’s, Clinical Trial Management Systems, Tumor Registries, Biospecimen Repositories, Radiology PAC systems, Digital Pathology archives, Unstructured Clinical Documents, and Next Generation Sequencing services. The System enables physicians to systematically mine and review the molecular, genomic, image-based, and correlated clinical information about patient tumors individually or as part of large cohorts to identify patterns that may influence treatment decisions and outcomes. The CRDW core system has facilitated peer-reviewed publications and funded projects, including an NIH-sponsored collaboration to enhance the cancer registries in Georgia, Kentucky, New Jersey, and New York, with machine-learning based classifications and quantitative pathomics, feature sets. The CRDW has also resulted in a collaboration with the Massachusetts Veterans Epidemiology Research and Information Center (MAVERIC) at the U.S. Department of Veterans Affairs to develop algorithms and workflows to automate the analysis of lung adenocarcinoma. Those studies showed that combining computational nuclear signatures with traditional WHO criteria through the use of deep convolutional neural networks (CNNs) led to improved discrimination among tumor growth patterns. The team has also leveraged the Warehouse to support studies to investigate the potential of utilizing a combination of genomic and computational imaging signatures to characterize prostate cancer. The results of those studies show that integrating image biomarkers with genomic pathway scores is more strongly correlated with disease recurrence than using standard clinical markers.

Keywords: clinical data warehouse, decision support, data-mining, intelligent databases, machine-learning.

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Authors: Lamiek Abraham, Xinli Du, Yohan Noh, Polin Hsu, Tingting Wu, Tom Logan, Ifan Yen

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In the field of minimally invasive, smart medical instruments such as catheters and guidewires are typically used at a remote distance to gain access to the diseased artery, often negotiating tortuous, complex, and diseased vessels in the process. Three optical fiber sensors with a diameter of 1.5mm each that are 120° apart from each other is proposed to be mounted into a catheter-based pump device with a diameter of 10mm. These sensors are configured to solve the challenges surgeons face during insertion through curvy major vessels such as the aortic arch. Moreover, these sensors deal with providing information on rubbing the walls and shape sensing. This study presents an experimental and mathematical models of the optical fiber sensors with 2 degrees of freedom. There are two eight gear-shaped tubes made up of 3D printed thermoplastic Polyurethane (TPU) material that are connected. The optical fiber sensors are mounted inside the first tube for protection from external light and used TPU material as a prototype for a catheter. The second tube is used as a flat reflection for the light intensity modulation-based optical fiber sensors. The first tube is attached to the linear guide for insertion and withdrawal purposes and can manually turn it 45° by manipulating the tube gear. A 3D hard material phantom was developed that mimics the aortic arch anatomy structure in which the test was carried out. During the insertion of the sensors into the 3D phantom, datasets are obtained in terms of voltage, distance, and position of the sensors. These datasets reflect the characteristics of light intensity modulation of the optical fiber sensors with a plane project of the aortic arch structure shape. Mathematical modeling of the light intensity was carried out based on the projection plane and experiment set-up. The performance of the system was evaluated in terms of its accuracy in navigating through the curvature and information on the position of the sensors by investigating 40 single insertions of the sensors into the 3D phantom. The experiment demonstrated that the sensors were effectively steered through the 3D phantom curvature and to desired target references in all 2 degrees of freedom. The performance of the sensors echoes the reflectance of light theory, where the smaller the radius of curvature, the more of the shining LED lights are reflected and received by the photodiode. A mathematical model results are in good agreement with the experiment result and the operation principle of the light intensity modulation of the optical fiber sensors. A prototype of a catheter using TPU material with three optical fiber sensors mounted inside has been developed that is capable of navigating through the different radius of curvature with 2 degrees of freedom. The proposed system supports operators with pre-scan data to make maneuverability and bendability through curvy major vessels easier, accurate, and safe. The mathematical modelling accurately fits the experiment result.

Keywords: Intensity modulated optical fiber sensor, mathematical model, plane projection, shape sensing.

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Authors: Brayden Mi

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Reverse time migration has been widely used in the Petroleum exploration industry to reveal subsurface images and to detect rock and fluid properties since the early 1980s. The seismic technology involves the construction of a velocity model through interpretive model construction, seismic tomography, or full waveform inversion, and the application of the reverse-time propagation of acquired seismic data and the original wavelet used in the acquisition. The methodology has matured from 2D, simple media to present-day to handle full 3D imaging challenges in extremely complex geological conditions. Conventional Ultrasound computed tomography (USCT) utilize travel-time-inversion to reconstruct the velocity structure of an organ. With the velocity structure, USCT data can be migrated with the “bend-ray” method, also known as migration. Its seismic application counterpart is called Kirchhoff depth migration, in which the source of reflective energy is traced by ray-tracing and summed to produce a subsurface image. It is well known that ray-tracing-based migration has severe limitations in strongly heterogeneous media and irregular acquisition geometries. Reverse time migration (RTM), on the other hand, fully accounts for the wave phenomena, including multiple arrives and turning rays due to complex velocity structure. It has the capability to fully reconstruct the image detectable in its acquisition aperture. The RTM algorithms typically require a rather accurate velocity model and demand high computing powers, and may not be applicable to real-time imaging as normally required in day-to-day medical operations. However, with the improvement of computing technology, such a computational bottleneck may not present a challenge in the near future. The present-day (RTM) algorithms are typically implemented from a flat datum for the seismic industry. It can be modified to accommodate any acquisition geometry and aperture, as long as sufficient illumination is provided. Such flexibility of RTM can be conveniently implemented for the application in USCT imaging if the spatial coordinates of the transmitters and receivers are known and enough data is collected to provide full illumination. This paper proposes an implementation of a full 3D RTM algorithm for USCT imaging to produce an accurate 3D acoustic image based on the Phase-shift-plus-interpolation (PSPI) method for wavefield extrapolation. In this method, each acquired data set (shot) is propagated back in time, and a known ultrasound wavelet is propagated forward in time, with PSPI wavefield extrapolation and a piece-wise constant velocity model of the organ (breast). The imaging condition is then applied to produce a partial image. Although each image is subject to the limitation of its own illumination aperture, the stack of multiple partial images will produce a full image of the organ, with a much-reduced noise level if compared with individual partial images.

Keywords: illumination, reverse time migration (RTM), ultrasound computed tomography (USCT), wavefield extrapolation

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Authors: Kristina Gordon

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One in three children in the United States is a victim of a maltreatment investigation, and about one in nine children has a substantiated investigation. Home visiting is one of several preventative strategies rooted in an early childhood approach that fosters maternal, infant, and early childhood health, protection, and growth. In the United States, 88% of states report administering home visiting programs or state-designed models. The purpose of this study was to conduct a systematic review on home visiting programs in the United States focused on the prevention of child abuse and neglect. This systematic review included 17 articles which found that most of the studies reported optimistic results. Common across studies was program content related to (1) typical child development, (2) parenting education, and (3) child physical health. Although several factors common to home visiting and parenting interventions have been identified, no research has examined the common components of manualized home visiting programs to prevent child maltreatment. Child maltreatment can be addressed with home visiting programs with evidence-based components and cultural adaptations that increase prevention by assisting families in tackling the risk factors they face. An innovative approach to child maltreatment prevention is bringing together at-risk families with the aging community. This innovative approach was prompted due to existing home visitation programs only focusing on improving skillsets and providing temporary relationships. This innovative approach can provide the opportunity for families to build a relationship with an aging individual who can share their wisdom, skills, compassion, love, and guidance, to support families in their well-being and decrease child maltreatment occurrence. Families would be identified if they experience any of the risk factors, including parental substance abuse, parental mental illness, domestic violence, and poverty. Families would also be identified as at risk if they lack supportive relationships such as grandparents or relatives. Families would be referred by local agencies such as medical clinics, hospitals, schools, etc., that have interactions with families regularly. The aging community would be recruited at local housing communities and community centers. An aging individual would be identified by the elderly community when there is a need or interest in a relationship by or for the individual. Cultural considerations would be made when assessing for compatibility between the families and aging individuals. The pilot program will consist of a small group of participants to allow manageable results to evaluate the efficacy of the program. The pilot will include pre-and post-surveys to evaluate the impact of the program. From the results, data would be created to determine the efficacy as well as the sufficiency of the details of the pilot. The pilot would also be evaluated on whether families were referred to Child Protective Services during the pilot as it relates to the goal of decreasing child maltreatment. The ideal findings will display a decrease in child maltreatment and an increase in family well-being for participants.

Keywords: child maltreatment, home visiting, neglect, preventative, abuse

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Authors: Fatma Ahmed, Heba Mostafa, Bassem Ramdan, Azza El-Soussi

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Background: World Health Organization stated that by 2020 cardiac disease will be the number one cause of death worldwide and estimates that 25 million people per year will suffer from heart disease. Cardiac surgery is considered an effective treatment for severe forms of cardiovascular diseases that cannot be treated by medical treatment or cardiac interventions. In spite of the benefits of cardiac surgery, it is considered a major stressful experience for patients who are candidate for surgery. Prehabilitation can decrease incidences of postoperative complications as it prepares patients for surgical stress through enhancing their defenses to meet the demands of surgery. When patients anticipate the postoperative sequence of events, they will prepare themselves to act certain behaviors, identify their roles and actively participate in their own recovery, therefore, anxiety levels are decreased and functional capacity is enhanced. Prehabilitation programs can comprise interventions that include physical exercise, psychological prehabilitation, nutritional optimization and risk factor modification. Physical exercises are associated with improvements in the functioning of the various physiological systems, reflected in increased functional capacity, improved cardiac and respiratory functions and make patients fit for surgical intervention. Prehabilitation programs should also prepare patients psychologically in order to cope with stress, anxiety and depression associated with postoperative pain, fatigue, limited ability to perform the usual activities of daily living through acting in a healthy manner. Notwithstanding the benefits of psychological preparations, there are limited studies which investigated the effect of psychological prehabilitation to confirm its effect on psychological, quality of life and physiological outcomes of patients who had undergone cardiac surgery. Aim of the study: The study aims to determine the effect of prehabilitation interventions on outcomes of patients undergoing cardiac surgeries. Methods: Quasi experimental study design was used to conduct this study. Sixty eligible and consenting patients were recruited and divided into two groups: control and intervention group (30 participants in each). One tool namely emotional, physiological, clinical, cognitive and functional capacity outcomes of prehabilitation intervention assessment tool was utilized to collect the data of this study. Results: Data analysis showed significant improvement in patients' emotional state, physiological and clinical outcomes (P < 0.000) with the use of prehabilitation interventions. Conclusions: Cardiac prehabilitation in the form of providing information about surgery, circulation exercise, deep breathing exercise, incentive spirometer training and nutritional education implemented daily by patients scheduled for elective open heart surgery one week before surgery have been shown to improve patients' emotional state, physiological and clinical outcomes.

Keywords: emotional recovery, clinical recovery, coronary artery bypass grafting patients, prehabilitation

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Authors: Tamrat Girma Biru

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Multidrug-resistant tuberculosis (MDR-TB) is defined as resistant to at least Refampicin and Isoniazed: the most two power full TB drugs. It is a leading cause of high rates of morbidity and mortality, and increasing psychosocial challenges to patients, especially when co-infected with Human Immunodeficiency Virus (HIV). Ethiopia faces the highest rates of MDR-TB infection in the world. Objectives: The main objective of this study was to identify the psychosocial challenges of MDR-TB patients, to investigate the extent of the psychosocial challenges on (self-esteem, depression, and stigma) that MDR-TB patients encounter, to examine whether there is a sex difference in experiencing psychosocial challenges and assess the counseling needs of MDR-TB patients. Methodology: A cross-sectional study was conducted at St. Peter TB Specialized Hospital, Addis Ababa on 40 patients (25 males and 15 females) who are hospitalized for treatment. The patients were identified by using purposive sampling and made fill a questionnaire measuring their level of self-esteem, depression and stigma. Besides, data were collected from 16 participants, 28 care providers and 8 guardians, using semi-structured interview. The obtained data were analyzed using SPSS statistical program, descriptive statistics, independent t-test, and qualitative description. Results and Discussion: The results of the study showed that the majority (80%) of the respondents had suffered psychological challenges and social discriminations. Thus, the significance of MDR-TB and its association with HIV/AIDS problems is considered. Besides the psychosocial challenges, various aggravating factors such as length of treatment, drug burden and insecurity in economy together highly challenges the life of patients. In addition, 60% of participants showed low level of self-esteem. The patients also reported that they experienced high self-stigma and stigma by other members of the society. The majority of the participants (75%) showed moderate and severe level of depression. In terms of sex there is no difference between the mean scores of males and females in the level of depression and stigmatization by others and by themselves. But females showed lower level of self-esteem than males. The analysis of the t-test also shows that there were no statistically significant sex difference on the level of depression and stigma. Based on the qualitative data MDR-TB patients face various challenges in their life sphere such as: Psychological (depression, low self value, lowliness, anxiety), social (stigma, isolation from social relations, self-stigmatization,) and medical (drug side effect, drug toxicity, drug burden, treatment length, hospital stays). Recommendations: Based on the findings of this study possible recommendations were forwarded: develop and extend MDR-TB disease awareness creation through by media (printing and electronic), school net TB clubs, and door to door community education. Strengthen psychological wellbeing and social relationship of MDR-TB patients using proper and consistent psychosocial support and counseling. Responsible bodies like Ministry of Health (MOH) and its stakeholders and Non Governmental Organizations (NGOs) need to assess the challenges of patients and take measures on this pressing issue.

Keywords: psychosocial challenges, counseling, multi-drug resistant tuberculosis (MDR-TB), tuberculosis therapy

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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: Benrithung Murry

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This paper highlights the biosocial determinants of health-seeking behavior in tribal population groups of northeast India, focusing on maternal and child health. The northeastern region of India is a conglomeration of several ethnic groups, most of which are scheduled as tribal groups. A total of 750 ever-married women in reproductive ages (15-49 years) were interviewed from three tribal groups of Nagaland, India using pre-tested and modified maternal health schedule. Data pertaining to reproductive performance of the mothers and their children health status were collected from 12 villages of Dimapur district, Nagaland, India. The sample for study comprises 212 Angami women, 267 Ao women, and 271 Sumi women, all of which belonging to tribal populations of Northeast India. Sex ratios of 15-49 years in these three populations are 1018.18, 1086.69, and 1106.92, respectively. 90% of the populations in the study are nuclear families, with about 10% of households falling below the poverty line as per the cutoffs for India. Female literacy level in these population groups is higher than the national average of 65.46%; however, about 30% of all married women are not engaged in any sort of earnings. Total fertility rates of these populations are alarming (Total Fertility Rate ≥ 6) and far from replacement fertility level, while infant mortality rates are found to be much lower than the national average of 34 per 1000. The perception and practice of maternal health in this region is unimpressive despite the availability of medical amenities. Only 3 % of mothers in the study have reported 4 times antenatal checkups during last two pregnancies. Other mothers have reported 1 to 3 times of antenatal checkups, but about 25% of them never visited a doctor during the entire pregnancy period. About 15% of mothers never took tetanus injection, while 40% of mothers never took iron folic supplements during pregnancy. Almost half of all women and their husbands do not use birth control measures even for the spacing of children, which has an immense impact on prenatal mortality mainly due to deliberate abortions: the percentage of prenatal mortality among Angami, Ao and Sumi populations is 44.88, 31.88 and 54.98, respectively per 1000 live births. The steep decline in fertility levels in most countries is a consequence of the increasing use of modern methods of contraception. However, among users of birth control measures in these populations, it is seen that most couples use it only after they have the desired number of children, thus its use having no substantial influence in reducing fertility. It is also seen that the majority of the children were only partially vaccinated. With many child deliveries being done at home, many newborns are not administered with polio at birth. Two-third of all children do not have complete basic immunization against polio, diphtheria, tetanus, pertussis, bacillus, and hepatitis besides others. Certain adherence to traditional beliefs and customs apart from the socio-economic factors is believed to have been operating in these populations, which determines their health-seeking behavior. While a more in-depth study combining biological, socio-cultural, economic, and genetic factors is suggested, there is an urgent need for intervention in these populations to combat with the poor maternal and child health status.

Keywords: case study, health behavior, mother and child, northeast india

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Authors: Dmitriy Yu. Korulkin, Raissa A. Muzychkina

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The last decade the growth of severe and disseminated forms of inflammatory diseases is observed in Kazakhstan, in particular, septic shock, which progresses on 3-15% of patients with infectious complications of postnatal period. In terms of the rate of occurrence septic shock takes third place after hemorrhagic and cardiovascular shock, in terms of lethality it takes first place. The structure of obstetric sepsis has significantly changed. Currently the first place is taken by postabortive sepsis (40%) that is connected with usage of imperfect methods of artificial termination of pregnancy in late periods (intraamnial injection of sodium chloride, glucose). The second place is taken by postnatal sepsis (32%); the last place is taken by septic complications of caesarean section (28%). In this connection, search for and assessment of effectiveness of new medicines for treatment of postoperative infectious complications, having biostimulating effect and speeding up regeneration processes, is very promising and topical. Essential oil was obtained by the method hydrodistillation air-dry aerial part of Sedum L. plants using Clevenger apparatus. Pilot batch of plant medicinal product based on Sedum essential oils was produced by Chimpharm JSC, Santo Member of Polpharma Group (Kazakhstan). During clinical test of the plant medicinal product based on Sedum L. essential oils 37 female patients at the age from 35 to 57 with clinical signs of complicated postoperative processes and 12 new mothers with clinical signs of inflammatory process on sutures on anterior abdominal wall after caesarean section and partial disruption of surgical suture line on perineum were examined. Medicine usage methods - surgical wound treatment 2 times a day, treatment with other medicines of local action was not performed. Before and after treatment general clinical test, determination of immune status, bacterioscopic test of wound fluid was performed to all women, medical history data was taken into account, wound cleansing and healing time, full granulations, side effects and complications, satisfaction with the used medicine was assessed. On female patients with inflammatory infiltration and partial disruption of surgical suture line anesthetic wound healing effect of plant medicinal product based on Sedum L. essential oils was observed as early as on the second day after beginning of using it, wound cleansing took place, as a rule, within the first row days. Hyperemia in the area of suture line also was not observed for 2-3-d day of usage of medicine, good constant course was observed. The absence of clinical effect on this group of patients was not registered. The represented data give evidence of that clinical effect was accompanied with normalization of changed laboratory findings. No allergic responses or side effects were observed during usage of the plant medicinal products based on Sedum L. essential oils.

Keywords: antiinflammatory, bioactive substances, essential oils, isolation, sedum L., wound healing

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Authors: Tomaz Oliveira, Rui Medeiros, André Lacerda

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Introduction: Cleft lip and/or palate are the most frequent forms of congenital craniofacial anomalies, affecting mainly the middle third of the face and manifesting by functional and aesthetic changes. Bilateral cleft lip represents a reconstructive surgical challenge, not only for the labial component but also for the associated nasal deformation. Recently, the paradigm of the approach to this pathology has changed, placing the focus on muscle reconstruction and anatomical repositioning of the nasal cartilages in order to obtain the best aesthetic and functional results. The aim of this study is to carry out a systematic review of the surgical approach to bilateral cleft lip, retrospectively analyzing the case series of Plastic Surgery Service at Hospital Santa Maria (Lisbon, Portugal) regarding this pathology, the global assessment of the characteristics of the operated patients and the study of the different surgical approaches and their complications in the last 20 years. Methods: The present work demonstrates a retrospective and descriptive study of patients who underwent at least one reconstructive surgery for cleft lip and/or palate, in the CPRE service of the HSM, in the period between January 1 of 1997 and December 31 of 2017, in which the data relating to 361 individuals were analyzed who, after applying the exclusion criteria, constituted a sample of 212 participants. The variables analyzed were the year of the first surgery, gender, age, type of orofacial cleft, surgical approach, and its complications. Results: There was a higher overall prevalence in males, with cleft lip and cleft palate occurring in greater proportion in males, with the cleft palate being more common in females. The most frequently recorded malformation was cleft lip and palate, which is complete in most cases. Regarding laterality, alterations with a unilateral labial component were the most commonly observed, with the left lip being described as the most affected. It was found that the vast majority of patients underwent primary intervention up to 12 months of age. The surgical techniques used in the approach to this pathology showed an important chronological variation over the years. Discussion: Cleft lip and/or palate is a medical condition associated with high aesthetic and functional morbidity, which requires early treatment in order to optimize the long-term outcome. The existence of a nasolabial component and its respective surgical correction plays a central role in the treatment of this pathology. The high rates of post-surgical complications and unconvincing aesthetic results have motivated an evolution of the surgical technique, increasingly evident in recent years, allowing today to achieve satisfactory aesthetic results, even in bilateral cleft lip with high deformation complexity. The introduction of techniques that favor nasolabial reconstruction based on anatomical principles has been producing increasingly convincing results. The analyzed sample shows that most of the results obtained in this study are, in general, compatible with the results published in the literature. Conclusion: This work showed that the existence of small variations in the surgical technique can bring significant improvements in the functional and aesthetic results in the treatment of bilateral cleft lip.

Keywords: cleft lip, palate lip, congenital abnormalities, cranofacial malformations

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Authors: Almas Rajguru

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The Oligocene succession of the Tapti- Daman area is one of the established petroleum plays in Tapti-Daman block of the Mumbai Offshore Basin. Despite good control and production history, the sand geometry and continuity of reservoir character of these sediments are less understood as most reservoirs are thin and fall below seismic resolution. The present work focuses on a detailed analysis of the Early Oligocene Mahuva Formation at the reservoir scale through laboratory studies (sedimentology and biostratigraphy) of core and sidewall cores in integration with electro logs for firming up facies’ distribution, micro-depositional environment and sequence stratigraphy, diagenesis and reservoir characterization from seventeen wells from North Tapti-C-37 area in Tapti Daman Block, WOB. The thick shale/claystone with thin interbeds of sandstone and siltstones of deeper marine in the lower part of Mahuva Fm represents deposition in a transgressive regime. The overlying interbedded sandstone, glauconitic-siltstone/fine-grained sandstone, and thin beds of packstone/grainstone within highly fissile shale were deposited in a prograding tide-dominated delta during late-rise normal regression. Nine litho facies (F1-F9) representing deposition in various microenvironments of the tide-dominated delta are identified based on their characteristic sediment texture, structure and microfacies. Massive, gritty sandstone (F1) with poorly sorted sands lithic fragments with calcareous and Fe-rich matrix represents channel fill sediments. High-angle cross-stratified sandstone (F2) deposited in rapidly shifting/migrating bars under strong tidal currents. F3 records the laterally accreted tidal-channel point bars. F3 (low-angle cross-stratified to parallel bedded sandstone) and F4 (Clean sandstone) are often associated with F2 in a tidal bar complex. F5 (interbedded thin sand and mud) and F6 (bioturbated sandstone) represent tidal flat deposits. High energy open marine carbonate shoals (F8) and fossiliferous sandstone in offshore bars (F7) represent deepening up facies. Shallow marine standstill conditions facilitated the deposition of thick shale (F9) beds. The reservoir facies (F1-F6) are commonly poorly to moderately sorted; bimodal, immature sandstone represented by quartz-wacke. The framework grains are sub-angular to sub-rounded, medium to coarse-grained (occasionally gritty) embedded within argillaceous (kaolinite/chlorite/chamosite) to highly Fe-rich matrix (sideritic). The facies F7 and F8, representing the sandy packstone and grainstone facies, respectively, exhibit poor reservoir characteristics due to sanitization, diagenetic compaction and matrix-filled intergranular spaces. The various diagenetic features such as the presence of authigenic clays (kaolinite/dickite/smectite); ferruginous minerals like siderite, pyrite, hematite and other iron oxides; bioturbations; glauconite; calcite and quartz cementation, precipitation of gypsum, pressure solution and other compaction effects are identified. These diagenetic features, wherever present, have reduced porosity and permeability thereby adversely affecting reservoir quality. Tidal bar sandstones possess good reservoir characteristics such as moderate to good sorting, fair to good porosity and geometry that facilitates efficient lateral extension and vertical thickness of reservoir. The sand bodies of F2, F3 and F4 facies of Well L, M and Q deposited in a tidal bar complex exhibit good reservoir quality represented by relatively cleaner, poorly burrowed, loose, friable sandstone with good porosity. Sandstone facies around these wells could prove a potential hydrocarbon reservoir and could be considered for further exploration.

Keywords: reservoir sedimentology, facies analysis, HST, tide dominated delta, tidal bars

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Authors: Jessica Neri, Elena Faccio

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In Europe, except for Denmark and Malta, the legal gender change and the stages of the possible process of gender transition are bound to the diagnosis of a gender identity disorder. The requirement of the evaluation of a mental disorder might have many implications on trans people’s self-representations, interpersonal relations in different social contexts and the therapeutic relations with clinicians during the transition. Psychopathological language may contribute to define the individual’s reality from normative presuppositions with value implications related to the dominant cultural principles. In an effort to mark the boundaries between sanity and pathology, it concurs to the definition of the management procedures of the constructed diversities and deviances, legitimizing the operational practices of particular professional figures. The aim of this research concerns the analysis of the diagnostic category of gender dysphoria contained in the last edition of the Diagnostic and Statistical Manual of Mental Disorders. In particular, this study focuses on the relationship between the implicit and explicit assumptions related to the expressions of gender non-conformity, that sustain the language and the criteria characterizing the Manual, and the possible implications on people’s narratives of transition. In order to achieve this objective two main research methods were used: historical reconstruction of the diagnostic category in the different versions of the Manual and content analysis of that category in the present version. From the historical analysis, in the medical and psychiatric field gender non-conformity has been predominantly explicated by naturalistic perspectives, naming it ‘transsexualism’ and collocating it in the category of gender identity disorder. Currently, pathological judged experiences are represented by gender dysphoria, described in the DSM-5 as the distress that may accompany the incongruence between one's experienced or expressed gender and one's assigned gender, specifying that there must be ‘evidence’ of this. Implicit theories about gender binary, parallelism between gender identity, sex and sexuality and the understanding of the mental health and the subject’s agency as subordinated to the expert knowledge, can be found in the process of designation of the category. A lack of awareness of the historical, social and political aspects connected to the cultural and normative dimensions at the basis of these implicit theories, can be noticed and data given by culture and data given by supposed -biological or psychological- nature, are often confused. This reductionist interpretation of gender and its presumed diversities legitimize the clinician to assume the role of searching and orienting, in a correctional perspective, the biographical elements that correspond to him specific expectations, with no space for other possibilities and identity configurations for people in transition. This research may contribute to the current critical debate about the epistemological foundation of the psychodiagnosis, emphasizing the pragmatic effects on the individuals and on the psychological practice in its wider social context. This work also permits to underline the risks due to the lack of awareness of the processes of social construction of the diagnostic system and its essential role of defence of the values that hold up the symbolic universe of reference.

Keywords: diagnosis, gender dysphoria, narratives, social constructionism

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Authors: Maria C. Proença, Maria T. Rebelo, Marília Antunes, Maria J. Alves, Hugo Osório, Sofia Cunha, REVIVE team

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The environment of the mosquitoes complex Culex pipiens sl. in Portugal mainland is evaluated based in its abundance, using a data set georeferenced, collected during seven years (2006-2012) from May to October. The suitability of the different regions can be delineated using the relative abundance areas; the suitablility index is directly proportional to disease transmission risk and allows focusing mitigation measures in order to avoid outbreaks of vector-borne diseases. The interest in the Culex pipiens complex is justified by its medical importance: the females bite all warm-blooded vertebrates and are involved in the circulation of several arbovirus of concern to human health, like West Nile virus, iridoviruses, rheoviruses and parvoviruses. The abundance of Culex pipiens mosquitoes were documented systematically all over the territory by the local health services, in a long duration program running since 2006. The environmental factors used to characterize the vector habitat are land use/land cover, distance to cartographed water bodies, altitude and latitude. Focus will be on the mosquito females, which gonotrophic cycle mate-bloodmeal-oviposition is responsible for the virus transmission; its abundance is the key for the planning of non-aggressive prophylactic countermeasures that may eradicate the transmission risk and simultaneously avoid chemical ambient degradation. Meteorological parameters such as: air relative humidity, air temperature (minima, maxima and mean daily temperatures) and daily total rainfall were gathered from the weather stations network for the same dates and crossed with the standardized females’ abundance in a geographic information system (GIS). Mean capture and percentage of above average captures related to each variable are used as criteria to compute a threshold for each meteorological parameter; the difference of the mean capture above/below the threshold was statistically assessed. The meteorological parameters measured at the net of weather stations all over the country are averaged by month and interpolated to produce raster maps that can be segmented according to the meaningful thresholds for each parameter. The intersection of the maps of all the parameters obtained for each month show the evolution of the suitable meteorological conditions through the mosquito season, considered as May to October, although the first and last month are less relevant. In parallel, mean and above average captures were related to the physiographic parameters – the land use/land cover classes most relevant in each month, the altitudes preferred and the most frequent distance to water bodies, a factor closely related with the mosquito biology. The maps produced with these results were crossed with the meteorological maps previously segmented, in order to get an index of suitability for the complex Culex pipiens evaluated all over the country, and its evolution from the beginning to the end of the mosquitoes season.

Keywords: suitability index, Culex pipiens, habitat evolution, GIS model

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Authors: Shunhong Qi, Hui Tian

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Triggered off by the forthcoming 2022 Winter Olympics, ski centers are blossoming in China, the number being 742 in 2018. Although the number of skier visits of ski resorts soared to 19.7 million in 2018, one-time skiers account for a considerable portion therein. In light of the extremely low return rates and skiing penetration level (0.5%) of leisure skiing in China, this study proposes and tests a leisure ski service performance framework which assesses the ski resorts’ service quality, skier satisfaction, as well as their impact on skiers’ behavioral intentions, with an aim to assess the success of ski resorts and provide suggestions for improvement. Three self-administered surveys and 16 interviews were conducted upon a convenience sample of leisure skiers in two major ski destinations within two hours’ drive from Beijing – Nanshan and Jundushan ski resorts. Of the 680 questionnaires distributed, 416 usable copies were returned, the response rate being 61.2%. The questionnaire used for the study was developed based on the existing literature of 'push' factors of skiers (intrinsic desire) and 'pull' factors (attractiveness of a destination), as well as leisure sport satisfaction. The scale comprises four parts: skiers’ demographic profiles, their perceived service quality (including ski resorts’ infrastructure, expense, safety and comfort, convenience, daily needs support, skill development support, and accessibility), their overall levels of satisfaction (satisfaction with the service and the experience), and their behavioral intentions (including loyalty, future visitation and greater tolerance of price increases). Skiers’ demographic profiles show that among the 220 males and 196 females in the survey, a vast majority of the skiers are age 17-39 (87.2%). 64.7% are not married, and nearly half (48.3%) of the skiers have a monthly family income exceeding 10,000 yuan (USD 1,424), and 80% are beginners or intermediate skiers. The regression examining the influence of service quality on skier satisfaction reveals that service quality accounts for 44.4% of the variance in skier satisfaction, the variables of safety and comfort, expense, skill development support, and accessibility contributing significantly in descending order. Another regression analyzing the influence of service quality as well as skier satisfaction on their behavioral intentions shows that service quality and skier satisfaction account for 39.1% of the variance in skiers’ behavioral intentions, and the significant predictors are skier satisfaction, safety and comfort, expense, and accessibility, in descending order, though a comparison between groups also indicates that for expert skiers, the significant variables are skier satisfaction, skill development support, safety, and comfort. Suggestions are thus made for ski resorts and other stakeholders to improve skier satisfaction and increase visitation: developing diversified ski courses to meet the demands of skiers of different skiing skills and to reduce crowding, adopting enough chairlifts and magic carpets, reinforcing safety measures and medical force; further exploring their various resources and lower the skiing expense on ski pass, equipment renting, accommodation and dining; adding more bus lines and/or develop platforms for skiers’ car-pooling, and offering diversified skiing activities with local flavors for better entertainment.

Keywords: behavioral intentions, leisure skiing, service quality, skier satisfaction

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Authors: Muhammad Fayyaz Nazir, Ellen Wayenberg, Shahzadaah Faahed Qureshi

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Introduction: The study is based on the Contextual Interaction Theory (CIT) constructs to explore the role of policy actors in implementing the COVID-19 Disease Prevention and Control (DP&C) Policy. The study analyzes the role of healthcare workers' contextual factors, such as cognition, motives, and resources, and their interactions in implementing Social Distancing (SD). In this way, we test a two actors policy implementation theory, i.e., the CIT in a three-actor context. Methods: Data was collected through document analysis and semi-structured interviews. For a qualitative study design, interviews were conducted with questions on cognition, motives, and resources from the healthcare workers involved in implementing SD in the local context in Multan – Pakistan. The possible interactions resulting from contextual factors of the policy actors – healthcare workers were identified through framework analysis protocol guided by CIT and supported by trustworthiness criterion and data saturation. Results: This inquiry resulted in theory application, addition, and enrichment. The theoretical application in the three actor's contexts illustrates the different levels of motives, cognition, and resources of healthcare workers – senior administrators, managers, and healthcare professionals. The senior administrators working in National Command and Operations Center (NCOC), Provincial Technical Committees (PTCs), and Districts Covid Teams (DCTs) were playing their role with high motivation. They were fully informed about the policy and moderately resourceful. The policy implementors: healthcare managers working on implementing the SD within their respective hospitals were playing their role with high motivation and were fully informed about the policy. However, they lacked the required resources to implement SD. The target medical and allied healthcare professionals were moderately motivated but lack of resources and information. The interaction resulted in cooperation and the need for learning to manage the future healthcare crisis. However, the lack of resources created opposition to the implementation of SD. Objectives of the Study: The study aimed to apply a two actors theory in a multi actors context. We take this as an opportunity to qualitatively test the theory in a novel situation of the Covid-19 pandemic and make way for its quantitative application by designing a survey instrument so that implementation researchers can apply CIT through multivariate analyses or higher-order statistical modeling. Conclusion: Applying two actors' implementation theory in exploring a complex case of healthcare intervention in three actors context is a unique work that has never been done before, up to the best of our knowledge. So, the work will contribute to the policy implementation studies by applying, extending, and enriching an implementation theory in a novel case of the Covi-19 pandemic, ultimately fulfilling the gap in implementation literature. Policy institutions and other low or middle-income countries can learn from this research and improve SD implementation by working on the variables with weak significance levels.

Keywords: COVID-19, disease prevention and control policy, implementation, policy actors, social distancing

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Authors: Wint Wint Thu, Htet Ko Ko Win, Myat Mon San, Zaw Lin Tun, Nandar Than Aye, Khin Nyein Myat, Hayman Nyo Oo, Nay Aung Lin, Kusum Thapa, Kyaw Htet Aung

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Background: In Myanmar, the intense political instability happened to start in Feb-2021, while the COVID-19 pandemic waves are also threatening the public health system, which subsequently led to severe health sector crisis, including difficulties in accessing maternal and newborn health care for vulnerable women and children. The Remote Pregnant and Newborn Care (RPNC) uses a telehealth approach United States Agency for International Development (USAID)-funded Essential Health Project. Implementation: The Remote Pregnant and Newborn Care (RPNC) service has adapted to the MNCH needs of vulnerable pregnant women and was implemented to mitigate the risk of limited access to essential quality MNH care in Yangon, Myanmar, under women, and the project trained 13 service providers on a telehealth care package for pregnancy and newborn developed Jhpiego to ensure understanding of evidence-based MNCH care practices. The phone numbers of the pregnant women were gathered through the preexisting and functioning community volunteers, who reach the most vulnerable pregnant women in the project's targeted area. A total of 212 pregnant women have been reached by service providers for RPNC during the implementation period. The trained service providers offer quality antenatal and postnatal care, including newborn care, via telephone calls. It includes 24/7 incoming calls and time-allotted outgoing calls to the pregnant women during antenatal and postnatal periods, including the newborn care. The required data were collected daily in time with the calls, and the quality of the medical services is made assured with the track of the calls, ensuring data privacy and patient confidentiality. Lessons learned: The key lessons are 1) cost-effectiveness: RPNC service could reduce out of pocket expenditure of pregnant women as it only costs 1.6 United States dollars (USD) per one telehealth call while it costs 8 to 10 USD per one time in-person care service at private service providers, including transportation cost, 2) network of care: telehealth call could not replace the in-person antenatal and postnatal care services, and integration of telehealth calls with in-person care by local healthcare providers with the support of the community is crucial for accessibility to essential MNH services by poor and vulnerable women, and 3) sharing information on health access points: most of the women seem to have financial barriers in accessing private health facilities while public health system collapse and telehealthcare could provide information on low-cost facilities and connect women to relevant health facilities. These key lessons are important for future efforts regarding the implementation of remote pregnancy and newborn care in Myanmar, especially during the political crisis and COVID-19 pandemic situation.

Keywords: telehealth, accessibility, maternal care, newborn care

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Authors: Vijayabhaskar Reddy Kandula, Peter Provost Taillac, Balasubramanya M. A., Ram Krishnan Nair, Gokul Toshnival, Vibhu Dhawan, Vijaya Karanam, Buffy Cramer

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Introduction: The lack of Emergency Care Services (ECS) is a cause of extensive and serious public health problems in low- and middle-income countries (LMIC), Many LMIC countries have ambulance services that allow timely transfer of ill patients but due to poor care during the ‘Golden Hour’ many deaths occur which are otherwise preventable. Lack of adequate training as evidenced by a study in India is a major reason for poor care during the ‘Golden Hour’. Adapting developed country models which includes staffing specialty-trained doctors in emergency care, is neither feasible nor guarantees cost-effective ECS. Methods: Based on our assessment and felt needs by first-line doctors providing emergency care in 2014, Rajiv Gandhi Health Sciences University’s JeevaRaksha Trust in partnership with the University of Utah, USA, designed, piloted and successfully implemented a 4-day Comprehensive-Emergency Care and Life Support course (C-ECLS) for allopathic doctors. 1730 doctors completed the 4-day course between June 2014 and December- 2020. Subsequently, we conducted a survey to investigate the utilization rates and usefulness of the training. 1662 were contacted but only 309 completed the survey. The respondents had the following designations: Senior faculty (33%), junior faculty (25), Resident (16%), Private-Practitioners (8%), Medical-Officer (16%) and not-working (11%). 51% were generalists (51%) and the rest were specialists (>30 specialties). Results: 97% (271/280) felt they are better doctors because of C-ECLS. 79% (244/309) reported that training helped to save life- specialists more likely than generalists (91% v/s 68%. P<0.05). 64% agreed that they were confident of managing COVID-19 symptomatic patients better because of C-ECLS. 27% (77) were neutral; 9% (24) disagreed. 66% agreed that training helps to be confident in managing COVID-19 critically ill patients. 26% (72) were neutral; 8% (23) disagreed. Frequency of use of C-ECLS skills: Hemorrhage-control (70%), Airway (67%), circulation skills (62%), Safe-transport and communication (60%), managing critically ill patients (58%), cardiac arrest (51%), Trauma (49%), poisoning/animal bites/stings (44%), neonatal-resuscitation (39%), breathing (36%), post-partum-hemorrhage and eclampsia (35%). Among those who used the skills, the majority (ranging from (88%-94%) reported that they were able to apply the skill more effectively because of ECLS training. Conclusion: JeevaRaksha’s C-ECLS is the world’s first comprehensive training. It improves the confidence of front-line doctors and enables them to provide quality care during the ‘Golden Hour’ of emergency. It also prepares doctors to manage unknown emergencies (e.g., COVID-19). C-ECLS was piloted in Morocco, and Uzbekistan and implemented countrywide in Bhutan. C-ECLS is relevant to most settings and offers a replicable model across LMIC.

Keywords: comprehensive emergency care and life support, training, capacity building, low- and middle-income countries, developing countries

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Authors: Kuo-Kai Lin, Po-Lun Chang

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Research Background and Purpose: Following the development of the Internet and multimedia, the Internet and information technology have become crucial avenues of modern communication and knowledge acquisition. The advantages of using mobile devices for learning include making learning borderless and accessible. Mobile learning has become a trend in disease management and health promotion in recent years. End-stage renal disease (ESRD) is an irreversible chronic disease, and patients who do not receive kidney transplants can only rely on hemodialysis or peritoneal dialysis to survive. Due to the complexities in caregiving for patients with ESRD that stem from their advanced age and other comorbidities, the patients’ incapacity of self-care leads to an increase in the need to rely on their families or primary caregivers, although whether the primary caregivers adequately understand and implement patient care is a topic of concern. Therefore, this study explored whether primary caregivers’ health care provisions can be improved through the intervention of an automatic speech intelligent system, thereby improving the objective health outcomes of patients undergoing long-term dialysis. Method: This study developed an automatic speech intelligent system with healthcare functions such as health information voice prompt, two-way feedback, real-time push notification, and health information delivery. Convenience sampling was adopted to recruit eligible patients from a hemodialysis center at a regional teaching hospital as research participants. A one-group pretest-posttest design was adopted. Descriptive and inferential statistics were calculated from the demographic information collected from questionnaires answered by patients and primary caregivers, and from a medical record review, a health care scale (recorded six months before and after the implementation of intervention measures), a subjective health assessment, and a report of objective physiological indicators. The changes in health care behaviors, subjective health status, and physiological indicators before and after the intervention of the proposed automatic speech intelligent system were then compared. Conclusion and Discussion: The preliminary automatic speech intelligent system developed in this study was tested with 20 pretest patients at the recruitment location, and their health care capacity scores improved from 59.1 to 72.8; comparisons through a nonparametric test indicated a significant difference (p < .01). The average score for their subjective health assessment rose from 2.8 to 3.3. A survey of their objective physiological indicators discovered that the compliance rate for the blood potassium level was the most significant indicator; its average compliance rate increased from 81% to 94%. The results demonstrated that this automatic speech intelligent system yielded a higher efficacy for chronic disease care than did conventional health education delivered by nurses. Therefore, future efforts will continue to increase the number of recruited patients and to refine the intelligent system. Future improvements to the intelligent system can be expected to enhance its effectiveness even further.

Keywords: automatic speech intelligent system for health care, primary caregiver, long-term hemodialysis, health care capabilities, health outcomes

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Authors: Waqas Ahmed Khan, Faheem Khokhaar

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Air pollution is one of the main perpetrators of climate change. GHGs cause melting of glaciers and cause change in temperature and heavy rain fall many gasses like Formaldehyde is not direct precursor that damage ozone like CO2 or Methane but Formaldehyde (HCHO) form glyoxal (CHOCHO) that has effect on ozone. Countries around the globe have unique air quality monitoring protocols to describe local air pollution. Formaldehyde is a colorless, flammable, strong-smelling chemical that is used in building materials and to produce many household products and medical preservatives. Formaldehyde also occurs naturally in the environment. It is produced in small amounts by most living organisms as part of normal metabolic processes. Pakistan lacks the monitoring facilities on larger scale to measure the atmospheric gasses on regular bases. Formaldehyde is formed from Glyoxal and effect mountain biodiversity and livelihood. So its monitoring is necessary in order to maintain and preserve biodiversity. Objective: Present study is aimed to measure atmospheric HCHO vertical column densities (VCDs) obtained from ground-base and compute HCHO data in Punjab and elevated areas (Rawalpindi & Islamabad) by satellite observation during the time period of 2014-2015. Methodology: In order to explore the spatial distributing of H2CO, various fields campaigns including international scientist by using car Max-Doas. Major focus was on the cities along national highways and industrial region of Punjab Pakistan. Level 2 data product of satellite instruments OMI retrieved by differential optical absorption spectroscopy (DOAS) technique are used. Spatio-temporal distribution of HCHO column densities over main cities and region of Pakistan has been discussed. Results: Results show the High HCHO column densities exceeding permissible limit over the main cities of Pakistan particularly the areas with rapid urbanization and enhanced economic growth. The VCDs value over elevated areas of Pakistan like Islamabad, Rawalpindi is around 1.0×1016 to 34.01×1016 Molecules’/cm2. While Punjab has values revolving around the figure 34.01×1016. Similarly areas with major industrial activity showed high amount of HCHO concentrations. Tropospheric glyoxal VCDs were found to be 4.75 × 1015 molecules/cm2. Conclusion: Results shows that monitoring site surrounded by Margalla hills (Islamabad) have higher concentrations of Formaldehyde. Wind data shows that industrial areas and areas having high economic growth have high values as they provide pathways for transmission of HCHO. Results obtained from this study would help EPA, WHO and air protection departments in order to monitor air quality and further preservation and restoration of mountain biodiversity.

Keywords: air quality, formaldehyde, Max-Doas, vertical column densities (VCDs), satellite instrument, climate change

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Authors: Alaa Abdellatif, Gabrièle Breda

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Background. Advanced therapy medicinal products (ATMPs) are innovative therapies that mainly target orphan diseases and high unmet medical needs. ATMP includes gene therapy medicinal products (GTMP), somatic cell therapy medicinal products (CTMP), and tissue-engineered therapies (TEP). Since legislation opened the way in 2007, 25 ATMPs have been approved in the EU, which is about the same amount as the U.S. Food and Drug Administration. However, not all of the ATMPs that have been approved have successfully reached the market and retained their approval. Objectives. We aim to understand all the factors limiting the market access to very promising therapies in a systemic approach, to be able to overcome these problems, in the future, with scientific, regulatory and commercial innovations. Further to recent reviews that focus either on specific countries, products, or dimensions, we will address all the challenges faced by ATMP development today. Methodology. We used mixed methods and a multi-level approach for data collection. First, we performed an updated academic literature review on ATMP development and their scientific and market access challenges (papers published between 2018 and April 2023). Second, we analyzed industry feedback from cell and gene therapy webinars and white papers published by providers and pharmaceutical industries. Finally, we established a comparative analysis of the regulatory guidelines published by EMA and the FDA for ATMP approval. Results: The main challenges in bringing these therapies to market are the high development costs. Developing ATMPs is expensive due to the need for specialized manufacturing processes. Furthermore, the regulatory pathways for ATMPs are often complex and can vary between countries, making it challenging to obtain approval and ensure compliance with different regulations. As a result of the high costs associated with ATMPs, challenges in obtaining reimbursement from healthcare payers lead to limited patient access to these treatments. ATMPs are often developed for orphan diseases, which means that the patient population is limited for clinical trials which can make it challenging to demonstrate their safety and efficacy. In addition, the complex manufacturing processes required for ATMPs can make it challenging to scale up production to meet demand, which can limit their availability and increase costs. Finally, ATMPs face safety and efficacy challenges: dangerous adverse events of these therapies like toxicity related to the use of viral vectors or cell therapy, starting material and donor-related aspects. Conclusion. As a result of our mixed method analysis, we found that ATMPs face a number of challenges in their development, regulatory approval, and commercialization and that addressing these challenges requires collaboration between industry, regulators, healthcare providers, and patient groups. This first analysis will help us to address, for each challenge, proper and innovative solution(s) in order to increase the number of ATMPs approved and reach the patients

Keywords: advanced therapy medicinal products (ATMPs), product development, market access, innovation

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Authors: Leen Al Kassab, Sarah Johns, Helen Noble, Nawal Nour, Elizabeth Janiak, Sarrah Shahawy

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Introduction: Immigrant and refugee women experience disparities in sexual and reproductive health (SRH) outcomes, partially as a result of barriers to SRH literacy and to regular healthcare access and engagement. Despite the existing data highlighting growing needs for culturally relevant and structurally competent care, interventions are scarce and not well-documented. Methods: In this IRB-approved study, we used a community-based participatory research approach, with the assistance of a community advisory board, to conduct a qualitative needs assessment of SRH knowledge and service engagement with immigrant and refugee women from Africa or the Middle East and currently residing in Boston. We conducted a total of nine focus group discussions (FGDs) in partnership with medical, community, and religious centers, in six languages: Arabic, English, French, Somali, Pashtu, and Dari. A total of 44 individuals participated. We explored migrant and refugee women’s current and evolving SRH care needs and gaps, specifically related to the development of interventions and clinical best practices targeting SRH literacy, healthcare engagement, and informed decision-making. Recordings of the FGDs were transcribed verbatim and translated by interpreter services. We used open coding with multiple coders who resolved discrepancies through consensus and iteratively refined our codebook while coding data in batches using Dedoose software. Results: Participants reported immigrant adaptation experiences, discrimination, and feelings of trust, autonomy, privacy, and connectedness to family, community, and the healthcare system as factors surrounding SRH knowledge and needs. The context of previously learned SRH knowledge was commonly noted to be in schools, at menstruation, before marriage, from family members, partners, friends, and online search engines. Common themes included empowering strength drawn from religious and cultural communities, difficulties bridging educational gaps with their US- born daughters, and a desire for more SRH education from multiple sources, including family, health care providers, and religious experts & communities. Regarding further SRH education, participants’ preferences varied regarding ideal platform (virtual vs. in-person), location (in religious and community centers or not), smaller group sizes, and the involvement of men. Conclusions: Based on these results, empowering SRH initiatives should include both community and religious center-based, as well as clinic-based, interventions. Interventions should be composed of frequent educational workshops in small groups involving age-grouped women, daughters, and (sometimes) men, tailored SRH messaging, and the promotion of culturally, religiously, and linguistically competent care.

Keywords: community, immigrant, religion, sexual & reproductive health, women's health

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Authors: Ramanpreet, Gursatej Gandhi

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Background: Dependence on electromagnetic radiations involved in communication and information technologies has incredibly increased in the personal and professional world. Among the numerous radiations, sources are fixed site transmitters, mobile phone base stations, and power lines beside indoor devices like cordless phones, WiFi, Bluetooth, TV, radio, microwave ovens, etc. Rather there is the continuous emittance of radiofrequency radiations (RFR) even to those not using the devices from mobile phone base stations. The consistent and widespread usage of wireless devices has build-up electromagnetic fields everywhere. In fact, the radiofrequency electromagnetic field (RF-EMF) has insidiously become a part of the environment and like any contaminant may pose to be health-hazardous requiring assessment. Materials and Methods: In the present study, cytogenetic damage was assessed using the Buccal Micronucleus Cytome (BMCyt) assay as a function of radiation exposure after Institutional Ethics Committee clearance of the study and written voluntary informed consent from the participants. On a pre-designed questionnaire, general information lifestyle patterns (diet, physical activity, smoking, drinking, use of mobile phones, internet, Wi-Fi usage, etc.) genetic, reproductive (pedigrees) and medical histories were recorded. For this, 24 hour-personal exposimeter measurements (PEM) were recorded for unrelated 60 healthy adults (40 cases residing in the vicinity of mobile phone base stations since their installation and 20 controls residing in areas with no base stations). The personal exposimeter collects information from all the sources generating EMF (TETRA, GSM, UMTS, DECT, and WLAN) as total RF-EMF uplink and downlink. Findings: The cases (n=40; 23-90 years) and the controls (n=20; 19-65 years) matched for alcohol drinking, smoking habits, and mobile and cordless phone usage. The PEM in cases (149.28 ± 8.98 mV/m) revealed significantly higher (p=0.000) electric field strength compared to the recorded value (80.40 ± 0.30 mV/m) in controls. The GSM 900 uplink (p=0.000), GSM 1800 downlink (p=0.000),UMTS (both uplink; p=0.013 and downlink; p=0.001) and DECT (p=0.000) electric field strength were significantly elevated in the cases as compared to controls. The electric field strength in the cases was significantly from GSM1800 (52.26 ± 4.49mV/m) followed by GSM900 (45.69 ± 4.98mV/m), UMTS (25.03 ± 3.33mV/m), DECT (18.02 ± 2.14mV/m) and was least from WLAN (8.26 ± 2.35mV/m). The higher significantly (p=0.000) increased exposure to the cases was from GSM (97.96 ± 6.97mV/m) in comparison to UMTS, DECT, and WLAN. The frequencies of micronuclei (1.86X, p=0.007), nuclear buds (2.95X, p=0.002) and cell death parameter (condensed chromatin cells) were significantly (1.75X, p=0.007) elevated in cases compared to that in controls probably as a function of radiofrequency radiation exposure. Conclusion: In the absence of other exposure(s), any cytogenetic damage if unrepaired is a cause of concern as it can cause malignancy. Larger sample size with the clinical assessment will prove more insightful of such an effect.

Keywords: Buccal micronucleus cytome assay, cytogenetic damage, electric field strength, personal exposimeter

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Authors: Elena I. Oprita, Oana Craciunescu, Rodica Tatia, Teodora Ciucan, Reka Barabas, Orsolya Raduly, Anca Oancea

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Healing of osteochondral defects requires repair of the damaged articular cartilage, the underlying subchondral bone and the interface between these tissues (the functional calcified layer). For this purpose, developing a single monophasic scaffold that can regenerate two specific lineages (cartilage and bone) becomes a challenge. The aim of this work was to develop variants of biodegradable cross-linked composite hydrogel based on natural polypeptides (gelatin), polysaccharides components (chondroitin-4-sulphate and hyaluronic acid), in a ratio of 2:0.08:0.02 (w/w/w) and mixed with Si-hydroxyapatite (Si-Hap), in two ratios of 1:1 and 2:1 (w/w). Si-Hap was synthesized and characterized as a better alternative to conventional Hap. Subsequently, both composite hydrogel variants were cross-linked with (N, N-(3-dimethylaminopropyl)-N-ethyl carbodiimide (EDC) and enriched with a small bioactive molecule (icariin). The small molecule icariin (Ica) (C33H40O15) is the main active constituent (flavonoid) of Herba epimedium used in traditional Chinese medicine to cure bone- and cartilage-related disorders. Ica enhances osteogenic and chondrogenic differentiation of bone marrow mesenchymal stem cells (BMSCs), facilitates matrix calcification and increases the specific extracellular matrix (ECM) components synthesis by chondrocytes. Afterward, the composite hydrogels were characterized for their physicochemical properties in terms of the enzymatic biodegradation in the presence of type I collagenase and trypsin, the swelling capacity and the degree of crosslinking (TNBS assay). The cumulative release of Ica and real-time concentration were quantified at predetermined periods of time, according to the standard curve of standard Ica, after hydrogels incubation in saline buffer at physiological parameters. The obtained cross-linked composite hydrogels enriched with small-molecule Ica were also characterized for morphology by scanning electron microscopy (SEM). Their cytocompatibility was evaluated according to EN ISO 10993-5:2009 standard for medical device testing. Thus, analyses regarding cell viability (Live/Dead assay), cell proliferation (Neutral Red assay) and cell adhesion to composite hydrogels (SEM) were performed using NCTC clone L929 cell line. The final results showed that both cross-linked composite hydrogel variants enriched with Ica presented optimal physicochemical, structural and biological properties to be used as a natural scaffold able to repair osteochondral defects. The data did not reveal any toxicity of composite hydrogels in NCTC stabilized cell lines within the tested range of concentrations. Moreover, cells were capable of spreading and proliferating on both composite hydrogel surfaces. In conclusion, the designed biodegradable cross-linked composites enriched with Si and Ica are recommended for further testing as natural temporary scaffolds, which can allow cell migration and synthesis of new extracellular matrix within osteochondral defects.

Keywords: composites, gelatin, osteochondral defect, small molecule

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Authors: Eda Ozkara San

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Nurse educators have been charged by several nursing organizations and accrediting bodies to provide innovative and evidence-based educational experiences, both didactic and clinical, to help students to develop the knowledge, skills, and attitudes needed to provide culturally competent nursing care to patients. Clinical simulation, which offers the opportunity for students to practice nursing skills in a risk-free, controlled environment and helps develop self-efficacy (confidence) within the nursing role. As one simulation method, the standardized patients (SPs) simulation helps educators to teach nursing students variety of skills in nursing, medicine, and other health professions. It can be a helpful tool for nurse educators to enhance cultural competence of nursing students. An alarming gap exists within the literature concerning the effectiveness of SP strategy to enhance cultural competence development of diverse student groups, who must work with patients from various backgrounds. This grant-supported, longitudinal, one-group, pretest and post-test educational intervention study aimed to examine the effect of the Diverse Standardized Patient Simulation (DSPS) cultural competence education strategy on students’ (n = 53) transcultural self-efficacy (TSE). The researcher-developed multidimensional DSPS strategy involved careful integration of transcultural nursing skills guided by the Cultural Competence and Confidence (CCC) model. As a carefully orchestrated teaching and learning strategy by specifically utilizing the SP pedagogy, the DSPS also followed international guidelines and standards for the design, implementation, evaluation, and SP training; and had content validity review. The DSPS strategy involved two simulation scenarios targeting underrepresented patient populations (Muslim immigrant woman with limited English proficiency and Irish-Italian American gay man with his partner (Puerto Rican) to be utilized in a second-semester, nine-credit, 15-week medical-surgical nursing course at an urban public US university. Five doctorally prepared content experts reviewed the DSPS strategy for content validity. The item-level content validity index (I-CVI) score was calculated between .80-1.0 on the evaluation forms. Jeffreys’ Transcultural Self-Efficacy Tool (TSET) was administered as a pretest and post-test to assess students’ changes in cognitive, practical, and affective dimensions of TSE. Results gained from this study support that the DSPS cultural competence education strategy assisted students to develop cultural competence and caused statistically significant changes (increase) in students’ TSE perceptions. Results also supported that all students, regardless of their background, benefit (and require) well designed cultural competence education strategies. The multidimensional DSPS strategy is found to be an effective way to foster nursing students’ cultural competence development. Step-by-step description of the DSPS provides an easy adaptation of this strategy with different student populations and settings.

Keywords: cultural competence development, the cultural competence and confidence model, CCC model, educational intervention, transcultural self-efficacy, TSE, transcultural self-efficacy tool, TSET

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Authors: Esra Sengul, R. G. Aktas, M. E. Sitar, H. Isan

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Hepatocellular carcinoma (HCC) is a hepatocellular tumor commonly found on the surface of the chronic liver. HepG2 is the most commonly used cell type in HCC studies. The main proteins remaining in the blood serum after separation of plasma fibrinogen are albumin and globulin. The fact that the albumin showed hepatocellular damage and reflect the synthesis capacity of the liver was the main reason for our use. Alpha-Fetoprotein (AFP) is an albumin-like structural embryonic globulin found in the embryonic cortex, cord blood, and fetal liver. It has been used as a marker in the follow-up of tumor growth in various malign tumors and in the efficacy of surgical-medical treatments, so it is a good protein to look at with albumins. We have seen the morphological changes of dimethyl sulfoxide (DMSO) on HepG2 and decided to investigate its biochemical effects. We examined the effects of DMSO, which is used in cell cultures, on albumin, AFP and total protein at low doses. Material Method: Cell Culture: Medium was prepared in cell culture using Dulbecco's Modified Eagle Media (DMEM), Fetal Bovine Serum Dulbecco's (FBS), Phosphate Buffered Saline and trypsin maintained at -20 ° C. Fixation of Cells: HepG2 cells, which have been appropriately developed at the end of the first week, were fixed with acetone. We stored our cells in PBS at + 4 ° C until the fixation was completed. Area Calculation: The areas of the cells are calculated in the ImageJ (IJ). Microscope examination: The examination was performed with a Zeiss Inverted Microscope. Daytime photographs were taken at 40x, 100x 200x and 400x. Biochemical Tests: Protein (Total): Serum sample was analyzed by a spectrophotometric method in autoanalyzer. Albumin: Serum sample was analyzed by a spectrophotometric method in autoanalyzer. Alpha-fetoprotein: Serum sample was analyzed by ECLIA method. Results: When liver cancer cells were cultured in medium with 1% DMSO for 4 weeks, a significant difference was observed when compared with the control group. As a result, we have seen that DMSO can be used as an important agent in the treatment of liver cancer. Cell areas were reduced in the DMSO group compared to the control group and the confluency ratio increased. The ability to form spheroids was also significantly higher in the DMSO group. Alpha-fetoprotein was lower than the values of an ordinary liver cancer patient and the total protein amount increased to the reference range of the normal individual. Because the albumin sample was below the specimen value, the numerical results could not be obtained on biochemical examinations. We interpret all these results as making DMSO a caretaking aid. Since each one was not enough alone we used 3 parameters and the results were positive when we refer to the values of a normal healthy individual in parallel. We hope to extend the study further by adding new parameters and genetic analyzes, by increasing the number of samples, and by using DMSO as an adjunct agent in the treatment of liver cancer.

Keywords: hepatocellular carcinoma, HepG2, dimethyl sulfoxide, cell culture, ELISA

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Authors: Ana L. M. Pavan, Guilherme Giacomini, Allan F. F. Alves, Marcela De Oliveira, Fernando A. B. Neto, Maria E. D. Rosa, Andre P. Trindade, Diana R. De Pina

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Mammography is a worldwide image modality used to diagnose breast cancer, even in asymptomatic women. Due to its large availability, mammograms can be used to measure breast density and to predict cancer development. Women with increased mammographic density have a four- to sixfold increase in their risk of developing breast cancer. Therefore, studies have been made to accurately quantify mammographic breast density. In clinical routine, radiologists perform image evaluations through BIRADS (Breast Imaging Reporting and Data System) assessment. However, this method has inter and intraindividual variability. An automatic objective method to measure breast density could relieve radiologist’s workload by providing a first aid opinion. However, pectoral muscle is a high density tissue, with similar characteristics of fibroglandular tissues. It is consequently hard to automatically quantify mammographic breast density. Therefore, a pre-processing is needed to segment the pectoral muscle which may erroneously be quantified as fibroglandular tissue. The aim of this work was to develop an automatic algorithm to segment and extract pectoral muscle in digital mammograms. The database consisted of thirty medio-lateral oblique incidence digital mammography from São Paulo Medical School. This study was developed with ethical approval from the authors’ institutions and national review panels under protocol number 3720-2010. An algorithm was developed, in Matlab® platform, for the pre-processing of images. The algorithm uses image processing tools to automatically segment and extract the pectoral muscle of mammograms. Firstly, it was applied thresholding technique to remove non-biological information from image. Then, the Hough transform is applied, to find the limit of the pectoral muscle, followed by active contour method. Seed of active contour is applied in the limit of pectoral muscle found by Hough transform. An experienced radiologist also manually performed the pectoral muscle segmentation. Both methods, manual and automatic, were compared using the Jaccard index and Bland-Altman statistics. The comparison between manual and the developed automatic method presented a Jaccard similarity coefficient greater than 90% for all analyzed images, showing the efficiency and accuracy of segmentation of the proposed method. The Bland-Altman statistics compared both methods in relation to area (mm²) of segmented pectoral muscle. The statistic showed data within the 95% confidence interval, enhancing the accuracy of segmentation compared to the manual method. Thus, the method proved to be accurate and robust, segmenting rapidly and freely from intra and inter-observer variability. It is concluded that the proposed method may be used reliably to segment pectoral muscle in digital mammography in clinical routine. The segmentation of the pectoral muscle is very important for further quantifications of fibroglandular tissue volume present in the breast.

Keywords: active contour, fibroglandular tissue, hough transform, pectoral muscle

Procedia PDF Downloads 322

Authors: Milada Krejci, Martin Hill, Vaclav Hosek, Dobroslava Jandova, Jiri Kajzar, Pavel Blaha

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The paper declares effects of exercise intervention of the research project “Basic research of balance changes in seniors”, granted by the Czech Science Foundation. The objective of the presented study is to define predictors, which influence bio-psycho-social consequences and effects of balance ability in senior 65 years old and above. We focused on the Fall-Efficacy Scale changes evaluation in seniors. Comprehensive hypothesis of the project declares, that motion uncertainty (dyskinesia) can negatively affect the well-being of a senior in bio-psycho-social context. In total, random selection and testing of 100 seniors (30 males, 70 females) from Prague and Central Bohemian region was provided. The sample was divided by stratified random selection into experimental and control groups, who underwent input and output testing. For diagnostics the methods of Medical Anamnesis, Functional anthropological examinations, Tinetti Balance Assessment Tool, SF-36 Health Survey, Anamnestic comparative self-assessment scale were used. Intervention method called "Life in Balance" based on yoga techniques was applied in four-week cycle. Results of multivariate regression were verified by repeated measures ANOVA: subject factor, phase of intervention (between-subject factor), body fluid (within-subject factor) and phase of intervention × body fluid interaction). ANOVA was performed with a repetition involving the factors of subjects, experimental/control group, phase of intervention (independent variable), and x phase interaction followed by Bonferroni multiple comparison assays with a test strength of at least 0.8 on the probability level p < 0.05. In the paper results of the first-year investigation of the three years running project are analysed. Results of balance tests confirmed no significant difference between females and males in pre-test. Significant improvements in balance and walking ability were observed in experimental group in females comparing to males (F = 128.4, p < 0.001). In the females control group, there was no significant change in post- test, while in the female experimental group positive changes in posture and spine flexibility in post-tests were found. It seems that females even in senior age react better to incentives of intervention in balance and spine flexibility. On the base of results analyses, we can declare the significant improvement in social balance markers after intervention in the experimental group (F = 10.5, p < 0.001). In average, seniors are used to take four drugs daily. Number of drugs can contribute to allergy symptoms and balance problems. It can be concluded that static balance and walking ability of seniors according Tinetti Balance scale correlate significantly with psychic and social monitored markers.

Keywords: exercises, balance, seniors 65+, health, mental and social balance

Procedia PDF Downloads 101

Authors: Abubakar Bello Usman, Alhassan Muhammad Gani, Kolo Ibrahim

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The use of botanical raw materials to produce pharmaceuticals, herbal remedies, teas, spirits, cosmetics, sweets, dietary supplements, special industrial compounds and crude materials constitute an important global resource in terms of healthcare and economy. In Nigeria and other developing countries, the indigenous knowledge on the uses of plants lies with the older generation and the traditional healers. However, these custodians are decreasing in number due to death and other unforeseen occurrences. An Ethno-botanical survey was carried out to obtain information on the ethno medical values of wide range of plants used by the people of Gombe State, North-Eastern Nigeria, in the practice of healing and cure of typhoid (enteric) fever. Oral interviews were conducted so as to consider those with low literacy level who are involved in the practice of traditional medicine and thirty four (34) informants availed themselves for the interview and were consulted. All relevant information obtained from the respondents was recorded. A recent and valid nomenclature, along with local names, family names, part of the plant(s) used, methods of preparation and administration and fifty four (54) plant species belonging to 27 families as well as 7 unidentified species that are commonly used by the people of the state in ethnomedical treatment of the ailment were tabulated. Those interviewed included traditional practitioners, local herb sellers, traditional rulers, hunters, farmers and patients. Specific questions were asked and information supplied by informants was promptly documented. Results showed that the people of Gombe State are knowledgeable on herbal medicine in the treatment of diseases and ailments. Furthermore, the aqueous leaf extracts of Senna siamea, the plant species with the highest PPK (percentage of people who have knowledge about the use of a species for treating typhoid fever) in this ethnobotanical survey, was tested for its activity against clinical isolates of Salmonella typhi using the agar well diffusion method. The aqueous extracts showed some activity (zones of inhibition 11, 9, 7.5, 3.5, 1.3 mm) at 2000, 1800, 1600, 1400, 1200 µg/ml concentrations respectively. Preliminary phytochemical studies of the aqueous leaf extracts of the plant revealed the presence of secondary metabolites such as alkaloids, saponins, tannins, flavonoids and cardiac glycosides. Though a large number of traditionally used plants for the treatment of enteric fever were identified, further scientific validation of the traditional claims of anti-typhoid properties is imperative. This would establish their candidature for any possible future research for active principles and the possible development of new cheaper and more effective anti-typhoid drugs, as well as in the conservation of this rich diversity of medicinal plants.

Keywords: antimicrobial activities, ethnobotany, gombe state, north-eastern Nigeria, phytochemical screening, senna siamea, typhoid fever

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Authors: Carolina L. Cerdeira, Julia V. F. Cortes, Maria E. V. Amarante, Gersika B. Santos

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Skin cancer is the most common cancer in several parts of the world; in a tropical country like Brazil, the situation isn’t different. The Brazilian population is exposed to high levels of solar radiation, increasing the risk of developing cutaneous carcinoma. Aimed at encouraging prevention measures and the early diagnosis of these tumors, a study was carried out that analyzed data on cutaneous melanomas, basal cell, and epidermoid carcinomas, using as primary data source the medical records of 161 patients registered in one pathology service, which performs skin biopsies in a city of Minas Gerais, Brazil. All patients diagnosed with skin cancer at this service from January 2015 to December 2019 were included. The incidence of skin carcinoma cases was correlated with the identification of histological type, sex, age group, and topographic location. Correlation between variables was verified by Fisher's exact test at a nominal significance level of 5%, with statistical analysis performed by R® software. A significant association was observed between age group and type of cancer (p=0.0085); age group and sex (0.0298); and type of cancer and body region affected (p < 0.01). Those 161 cases analyzed comprised 93 basal cell carcinomas, 66 epidermoid carcinomas, and only two cutaneous melanomas. In the group aged 19 to 30 years, the epidermoid form was most prevalent; from 31 to 45 and from 46 to 59 years, the basal cell prevailed; in 60-year-olds or over, both types had higher frequencies. Associating age group and sex, in groups aged 18 to 30 and 46 to 59 years, women were most affected. In the 31-to 45-year-old group, men predominated. There was a gender balance in the age group 60-year-olds or over. As for topography, there was a high prevalence in the head and neck, followed by upper limbs. Relating histological type and topography, there was a prevalence of basal cell and epidermoid carcinomas in the head and neck. In the chest, the basal cell form was most prevalent; in upper limbs, the epidermoid form prevailed. Cutaneous melanoma affected only the chest and upper limbs. About 82% of patients 60-year-olds or over had head and neck cancer; from 46 to 59 and 60-year-olds or over, the head and neck region and upper limbs were predominantly affected; the distribution was balanced in the 31-to 45-year-old group. In conclusion, basal cell carcinoma was predominant, whereas cutaneous melanoma was the rarest among the types analyzed. Patients 60-year-olds or over were most affected, showing gender balance. In young adults, there was a prevalence of the epidermoid form; in middle-aged patients, basal cell carcinoma was predominant; in the elderly, both forms presented with higher frequencies. There was a higher incidence of head and neck cancers, followed by malignancies affecting the upper limbs. The epidermoid type manifested significantly in the upper limbs. Body regions such as the thorax and lower limbs were less affected, which is justified by the lower exposure of these areas to incident solar radiation.

Keywords: basal cell carcinoma, cutaneous melanoma, skin cancer, squamous cell carcinoma, topographic location

Procedia PDF Downloads 100

Authors: Scott M. Black, Craig Maclean, Pauline Hall Barrientos, Konstantinos Ritos, Asimina Kazakidi

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Aortic aneurysms and dissections are leading causes of death in cardiovascular disease. Both inevitably lead to hemodynamic instability without surgical intervention in the form of vascular stent-graft deployment. An accurate description of the aortic geometry and blood flow in patient-specific cases is vital for treatment planning and long-term success of such grafts, as they must generate physiological branch perfusion and in-stent hemodynamics. The aim of this study was to create patient-specific computational fluid dynamics (CFD) models through a multi-modality, multi-dimensional approach with boundary condition optimization to predict branch flow rates and in-stent hemodynamics in custom stent-graft configurations. Three-dimensional (3D) thoracoabdominal aortae were reconstructed from four-dimensional flow-magnetic resonance imaging (4D Flow-MRI) and computed tomography (CT) medical images. The former employed a novel approach to generate and enhance vessel lumen contrast via through-plane velocity at discrete, user defined cardiac time steps post-hoc. To produce patient-specific boundary conditions (BCs), the aortic geometry was reduced to a one-dimensional (1D) model. Thereafter, a zero-dimensional (0D) 3-Element Windkessel model (3EWM) was coupled to each terminal branch to represent the distal vasculature. In this coupled 0D-1D model, the 3EWM parameters were optimized to yield branch flow waveforms which are representative of the 4D Flow-MRI-derived in-vivo data. Thereafter, a 0D-3D CFD model was created, utilizing the optimized 3EWM BCs and a 4D Flow-MRI-obtained inlet velocity profile. A sensitivity analysis on the effects of stent-graft configuration and BC parameters was then undertaken using multiple stent-graft configurations and a range of distal vasculature conditions. 4D Flow-MRI granted unparalleled visualization of blood flow throughout the cardiac cycle in both the pre- and postsurgical states. Segmentation and reconstruction of healthy and stented regions from retrospective 4D Flow-MRI images also generated 3D models with geometries which were successfully validated against their CT-derived counterparts. 0D-1D coupling efficiently captured branch flow and pressure waveforms, while 0D-3D models also enabled 3D flow visualization and quantification of clinically relevant hemodynamic parameters for in-stent thrombosis and graft limb occlusion. It was apparent that changes in 3EWM BC parameters had a pronounced effect on perfusion distribution and near-wall hemodynamics. Results show that the 3EWM parameters could be iteratively changed to simulate a range of graft limb diameters and distal vasculature conditions for a given stent-graft to determine the optimal configuration prior to surgery. To conclude, this study outlined a methodology to aid in the prediction post-surgical branch perfusion and in-stent hemodynamics in patient specific cases for the implementation of custom stent-grafts.

Keywords: 4D flow-MRI, computational fluid dynamics, vascular stent-grafts, windkessel

Procedia PDF Downloads 147