Search results for: healthcare narratives

Authors: A. Anastasiou, K. S. Tingay

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Background: Discovering suitable datasets is an important part of health research, particularly for projects working with clinical data from patients organized in cohorts (cohort data), but with the proliferation of so many national and international initiatives, it is becoming increasingly difficult for research teams to locate real world datasets that are most relevant to their project objectives. We present a method for identifying healthcare institutes in the European Union (EU) which may hold haemato-oncology (HO) data. A key enabler of this research was the bibInsight platform, a scientometric data management and analysis system developed by the authors at Swansea University. Method: A PubMed search was conducted using HO clinical terms taken from previous work. The resulting XML file was processed using the bibInsight platform, linking affiliations to the Global Research Identifier Database (GRID). GRID is an international, standardized list of institutions, including the city and country in which the institution exists, as well as a category of the main business type, e.g., Academic, Healthcare, Government, Company. Countries were limited to the 28 current EU members, and institute type to 'Healthcare'. An article was considered valid if at least one author was affiliated with an EU-based healthcare institute. Results: The PubMed search produced 21,310 articles, consisting of 9,885 distinct affiliations with correspondence in GRID. Of these articles, 760 were from EU countries, and 390 of these were healthcare institutes. One affiliation was excluded as being a veterinary hospital. Two EU countries did not have any publications in our analysis dataset. The results were analysed by country and by individual healthcare institute. Networks both within the EU and internationally show institutional collaborations, which may suggest a willingness to share data for research purposes. Geographical mapping can ensure that data has broad population coverage. Collaborations with industry or government may exclude healthcare institutes that may have embargos or additional costs associated with data access. Conclusions: Data reuse is becoming increasingly important both for ensuring the validity of results, and economy of available resources. The ability to identify potential, specific data sources from over twenty thousand articles in less than an hour could assist in improving knowledge of, and access to, data sources. As our method has not yet specified if these healthcare institutes are holding data, or merely publishing on that topic, future work will involve text mining of data-specific concordant terms to identify numbers of participants, demographics, study methodologies, and sub-topics of interest.

Keywords: data reuse, data discovery, data linkage, journal articles, text mining

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Authors: Yi-Fan Lin, Peter P. Howley, Frank A. Tuyl

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Quality measurement and reporting systems are used in healthcare internationally. In Australia, the Australian Council on Healthcare Standards records and reports hundreds of clinical indicators (CIs) nationally across the healthcare system. These CIs are measures of performance in the clinical setting, and are used as a screening tool to help assess whether a standard of care is being met. Existing analysis and reporting of these CIs incorporate Bayesian methods to address sampling variation; however, such assessments are retrospective in nature, reporting upon the previous six or twelve months of data. The use of Bayesian methods within statistical process control for monitoring systems is an important pursuit to support more timely decision-making. Our research has developed and assessed a new graphical monitoring tool, similar to a control chart, based on the beta-binomial posterior predictive (BBPP) distribution to facilitate the real-time assessment of health care organizational performance via CIs. The BBPP charts have been compared with the traditional Bernoulli CUSUM (BC) chart by simulation. The more traditional “central” and “highest posterior density” (HPD) interval approaches were each considered to define the limits, and the multiple charts were compared via in-control and out-of-control average run lengths (ARLs), assuming that the parameter representing the underlying CI rate (proportion of cases with an event of interest) required estimation. Preliminary results have identified that the BBPP chart with HPD-based control limits provides better out-of-control run length performance than the central interval-based and BC charts. Further, the BC chart’s performance may be improved by using Bayesian parameter estimation of the underlying CI rate.

Keywords: average run length (ARL), bernoulli cusum (BC) chart, beta binomial posterior predictive (BBPP) distribution, clinical indicator (CI), healthcare organization (HCO), highest posterior density (HPD) interval

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Authors: Rebekah Volgin, Jane Shakespeare-Finch, Ian Shochet

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Commercial sexual exploitation (CSE) and sex trafficking affect between 5000-7000 girls and women in Nepal each year and can have devastating physical and psychological consequences. Much research has documented these effects, however, there is no published longitudinal research that focuses on whether healing and growth outcomes are possible for survivors of CSE and sex trafficking. The narratives of 27 girls and women (13-22 years) were taken at two-time points during participation in a six-week group psychoeducation and art therapy program which was delivered across three NGO’s in Kathmandu, Nepal. These narratives form part of a larger ethnographic project. Thematic analysis of the data was undertaken. Themes emerging from time point 1 were: psychological distress in the form of anxiety and grief over loss of family, psychosomatic symptoms, empathy and compassion, and posttraumatic growth (PTG) in the form of new possibilities, relating to others and personal strength. Posttraumatic growth refers to positive changes in the aftermath of trauma. The themes emerging from time point 2, were: empathy and compassion and PTG (cognitive restructuring, new possibilities, relating to others and personal strength). Alongside the distress that these participants experienced, they also experienced positive outcomes such as empathy and compassion and psychological growth. Future research would advance knowledge by further examining the process of PTG in this population, if the changes observed were lasting, and if so, ways in which PTG can be facilitated or promoted.

Keywords: commercial sexual exploitation, human trafficking, posttraumatic growth, sexual trauma

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Authors: A. Shirazibeheshti, T. Radwan, A. Ettefaghian, G. Wilson, C. Luca, Farbod Khanizadeh

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Anticholinergic medication has been associated with events such as falls, delirium, and cognitive impairment in older patients. To further assess this, anticholinergic burden scores have been developed to quantify risk. A risk model based on clustering was deployed in a healthcare management system to cluster patients into multiple risk groups according to anticholinergic burden scores of multiple medicines prescribed to patients to facilitate clinical decision-making. To do so, anticholinergic burden scores of drugs were extracted from the literature, which categorizes the risk on a scale of 1 to 3. Given the patients’ prescription data on the healthcare database, a weighted anticholinergic risk score was derived per patient based on the prescription of multiple anticholinergic drugs. This study was conducted on over 300,000 records of patients currently registered with a major regional UK-based healthcare provider. The weighted risk scores were used as inputs to an unsupervised learning algorithm (mean-shift clustering) that groups patients into clusters that represent different levels of anticholinergic risk. To further evaluate the performance of the model, any association between the average risk score within each group and other factors such as socioeconomic status (i.e., Index of Multiple Deprivation) and an index of health and disability were investigated. The clustering identifies a group of 15 patients at the highest risk from multiple anticholinergic medication. Our findings also show that this group of patients is located within more deprived areas of London compared to the population of other risk groups. Furthermore, the prescription of anticholinergic medicines is more skewed to female than male patients, indicating that females are more at risk from this kind of multiple medications. The risk may be monitored and controlled in well artificial intelligence-equipped healthcare management systems.

Keywords: anticholinergic medicines, clustering, deprivation, socioeconomic status

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Authors: Mohamad Shariff Nurasikin, Paul Crawford, Nicola Wright

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People with any mental disorder can get benefit from the spiritual aspects of life for recovery, particularly in searching for the meaning of life and engaging in meaningful activities. However, little is known about such effects in the population of bipolar disorder. The concepts of spirituality are highly contestable, as they are too broad and removed from the original religious understanding. The concepts are more notable as encompassing multi-dimensional aspects of people’s lives such as social, emotional, and psychological. Viewing that Western or secular worldview dominates most of the literature in spirituality, it is time to explore the concept of spirituality from the Eastern and religious worldview, such as the Malaysian view. Thus, the aim of this study is to provide a conceptual understanding of people with bipolar disorder with a religious affiliation in Malaysia. This study employs a Grounded Theory and explores the narratives from the interviews of 25 participants. The narratives strongly suggest the salient resources or can be referred to as various forms of capital, as in the capital theory, namely, religious, social, psychological, and medicinal. More important is how these capitals are the enablers for recovery in mental health and well-being, where the participants in the sample engage in a more meaningful life and positive adaptations. This study also extends the Bourdieusian spiritual capital, in which the salient resources are termed as the capital bundle. More significant is how the capital bundles are working contiguously in building and accumulating the spiritual capital. This process is conducive to recovery within the social life of people with bipolar disorder or perhaps other mental disorders.

Keywords: bipolar, Bourdeau, recovery, spiritual

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Authors: Peter Ecke

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This research presents insights from a questionnaire study and autobiographic narrative analyses about the language and cultural backgrounds, challenges, interests, and needs, as well as perceptions about bilingualism and language learning of undergraduate students at a Public University in the southwestern United States. Participants were 650 students, enrolled in college-level general education courses, entitled “Becoming multilingual: Learning and maintaining two or more languages” between 2020 and 2024. Data were collected via pre- and post-course questionnaires administered online through the Qualtrix XM platform and complemented with analyses of excerpts from autobiographical narratives that students produced as part of the course assignments. Findings, for example, show that course participants have diverse linguistic backgrounds. The five most frequently reported L1s were English (about 50% of course participants), Spanish, Arabic, Mandarin, and Korean (in that order). The five most frequently reported L2s were English, Spanish, French, ASL, Japanese, German, and Mandarin (in that order). Participants also reported on their L2, L3, L4, and L5 if applicable. Most participants (over 60%) rated themselves bilingual or multilingual whereas 40% considered themselves to be monolingual or foreign language learners. Only about half of the participants reported feeling very or somewhat comfortable with their language skills, but these reports changed somewhat from the pre- to the post-course survey. About half of participants were mostly interested in learning how to effectively learn a foreign language. The other half of participants reported being most curious about learning about themselves as bi/multilinguals, (re)learning a language used in childhood, learning how to bring up a child as a bi/multilingual or learning about people who speak multiple languages (distributed about evenly). Participants’ comments about advantages and disadvantages of being bilingual remained relatively stable but their agreement with common myths about bilingualism and language learning changed from the pre- to the post-course survey. Students’ reflections in the autobiographical narratives and comments in (institutionally administered) anonymous course evaluations provided additional data on students’ concerns about their current language skills and uses as well as their perceptions about learning outcomes and the usefulness of the general education course for their current and future lives. It is hoped that the presented findings and discussion will spark interest among colleagues in offering similar courses as a resource for college students (and possibly other audiences), including those from migrant, indigenous, multilingual, and multicultural communities to contribute to a more harmonious bilingualism and well-being of college students who are or inspire to become bi-or multilingual.

Keywords: autobiographic narratives, general education university course, harmonious bilingualism and well-being, multilingualism, questionnaire study

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Authors: Kornelia Kordiak

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The research is based on a biographical approach and serves as a foundation for understanding individual human destinies through the analysis of the context of life experiences. It focuses on the significance of childhood in shaping family micro-worlds from the perspective of biographical learning. In this case, the family micro-world is interpreted as a complex of beliefs and judgments about elements of the ‘total universe’ based on the individual's experiences. The main aim of the research is to understand the importance of childhood in shaping family micro-worlds from the perspective of reflection on biographical learning. Additionally, it contributes to a deeper understanding of the familial experiences of the studied individuals who form these family micro-worlds and the course of the biographical learning process in the subjects. Biographical research aligns with an interpretative paradigm, where individuals are treated as active interpreters of the world, giving meaning to their experiences and actions based on their own values and beliefs. The research methods used in the project—narrative interview method and analysis of personal documents—enable obtaining a multidimensional perspective on the phenomenon under study. Narrative interviews serve as the main data collection method, allowing researchers to delve into various life contexts of individuals. Analysis of these narratives identifies key moments and life patterns, as well as discovers the significance of childhood in shaping family micro-worlds. Moreover, analysis of personal documents such as diaries or photographs enriches the understanding of the studied phenomena by providing additional contexts and perspectives. The research will be conducted in three phases: preparatory, main, and final. The anticipated schedule includes preparation of research tools, selection of research sample, conducting narrative interviews and analysis of personal documents, as well as analysis and interpretation of collected research material. The narrative interview method and document analysis will be utilized to capture various contexts and interpretations of childhood experiences and family relations. The research will contribute to a better understanding of family dynamics and individual developmental processes. It will allow for the identification and understanding of mechanisms of biographical learning and their significance in shaping identity and family relations. Analysis of adult narratives will enable the identification of factors determining patterns of behavior and attitudes in adult life, which may have significant implications for pedagogical practice.

Keywords: childhood, adulthood, biographical learning, narrative interview, analysis of personal documents, family micro-worlds

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Authors: Ehsan K. Hazaveh

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This research project explores creative methods of storytelling through photography to portray a vulnerable and marginalised community: former refugees living in Wellington, New Zealand. The project explores photographic representational techniques that can not only empower and give voice to those communities but also challenge dominant stereotypes about refugees and support humanitarian actions. The aims of this study are to develop insights surrounding issues associated with the photographic representation of refugees and to explore the collaborative construction of possible counter-narratives that might lead to the formulation of a practice framework for representing refugees using photography. In other words, the goal of this study is to explore representational and narrative strategies that frame refugees as active community members and as individuals with specific histories and expertise. These counter-narratives will bring the diversity of refugees to the surface by offering personal stories, contextualising their experience, raising awareness about the plight and human rights of the refugee community in New Zealand, evoking empathy and, therefore, facilitating the process of social change. The study has designed a photographic narrative framework by determining effective methods of photo storytelling, framing, and aesthetic techniques, focusing on different ways of taking, selecting, editing and curating photographs. Photo elicitation interviews have been used to ‘explore’, ‘produce’ and ‘co-curate’ the counter-narrative along with participants. Photo elicitation is a qualitative research method that employs images to evoke data in order to find out how other people experience their world - the researcher shows photographs to the participant and asks open-ended questions to get them to talk about their life experiences and the world around them. The qualitative data have been collected and produced through interactions with four former refugees living in Wellington, New Zealand. In this way, this project offers a unique account of their conditions and basic knowledge about their living experience and their stories. The participants of this study have engaged with PhotoVoice, a photo elicitation methodology that employs photography and storytelling, to share activities, emotions, hopes, and aspects of their lived experiences. PhotoVoice was designed to empower members of marginalised populations. It involves a series of meeting sessions, in which participants share photographs they have taken and discuss stories about the photographs to identify, represent, and enhance the issues important to their lives and communities. Finally, the data provide a basis for systematically producing visual counter-narratives that highlight the experiences of former- refugees. By employing these methods, refugees can represent their world as well as interpret it. The process of developing this research framing has enabled the development of powerful counter-narratives that challenge prevailing stereotypical depictions which in turn have the potential to shape improved humanitarian outcomes, shifts in public attitudes and political perspectives in New Zealand.

Keywords: media, photography, refugees, photo-elicitation, storytelling

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Authors: Wesam Darawsheh

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Background: there are scarcity of studies done to investigate the level of knowledge and the level of awareness and perception of Jordanians about occupational therapy (OT). Aim: to investigate the level of awareness of lay people, clients receiving services and healthcare professionals of OT, identify the common misconceptions about OT, and to explore ways whereby the knowledge and awareness about OT can be increased. Methodology: a cross sectional design was employed in this study where a survey was distributed in the Northern, Southern, Western, Eastern provinces and the Middle (capital city: Amman) province of Jordan. The survey consisted of eight section and 61 questions that aims to investigate the demographics of participants, self evaluation concerning knowledge and awareness about OT, sources of knowledge about OT, the perception of the aims, fields of practice, OT settings, misconceptions about OT, and suggestion to improve knowledge and awareness about OT. Results: A total of 829 participants were enrolled in this study: 459 lay people, 155 clients who are currently receiving OT services, 215 healthcare professionals. About 57% of the participants did not hear about OT, and 48% of those who reported to hear about OT did not have sufficient knowledge about it. There are several misconceptions associated with OT. The statistical analysis was executed using IBM SPSS software, Version 22.0 (SPSS, Chicago, USA). Conclusion: it is the responsibility of OTRs to increase the knowledge and awareness about OT in Jordan. This is required for the profession to proliferate and to be given its status.

Keywords: knowledge, occupational therapy misconceptions, healthcare professionals, lay people, Jordan

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Authors: Luxi Chen

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The land finance in China in recent years has propelled urban renewals in the name of historical conservation and led to massive gentrification and compulsory relocation. Such inequalities cause insurgence. Drawing on public planning information, ethnographic field notes, and online interview data about Guangzhou's Enninglu Area, this paper aims to present how such insurgence has been contained and put down gradually through depoliticization narratives represented by "improving living conditions," "conserving historical culture," and "public participation”. This paper's findings include that 1) Besides economic growth, maintaining social stability in alignment with the central government are equally important to local government, reveals the latter efforts to mediate the growth coalition, residents, media, and academics so as to reconstruct the interface between state and society; 2) To empower the insurgence, the media and academics use public interests for propaganda, that diverts attention away from its political dimension; 3) In response, the government introduces improved regulations and planning, turning social inequalities into technical inadequacy so as to become the defender of public interests, which justifies the incoming renewal and prevents public questioning. By comparing regime changes among governments, developers, residents, media, and academics caused by renewal policies, this paper presents the depoliticized narrative as a counter-insurgence strategy to contain social conflicts and to boost inner-city renewal.

Keywords: inner city renewal, depoliticization, historical conservation, public participation

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Authors: N. M. Sani, I. Bitrus, A. M. Sarki, N. S. Mujahid

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Hepatitis is one of the neglected infectious diseases in sub Saharan Africa, and most of the available data is based on blood donors. Health care workers (HCWs) often get infected as a result of their close contact with patients. A cross-sectional study was conducted to determine the prevalence of hepatitis B and C among this group of professionals with a view to improving the quality of care to their patients. Hepatitis B and C infections pose a major public health problem worldwide. While infection is highest in the developing world particularly Asia and sub-Saharan Africa, healthcare workers are at higher risk of acquiring blood-borne viral infections, particularly Hepatitis B and C which are mostly asymptomatic. This study was aimed at determining the prevalence of Hepatitis B and C infections and associated risk factors among health care workers in Dutse Metropolis, Jigawa State - Nigeria. A standard rapid immuno-chromatographic technique i.e. rapid ELISA was used to screen all sera for Hepatitis B surface antigen (HBsAg) and Hepatitis C viral antibody (HCVAb) respectively. Strips containing coated antibodies and antigens to HBV and HCV respectively were removed from the foil. Strips were labeled according to samples. Using a separate disposable pipette, 2 drops of the sample (plasma) were added into each test strip and allowed to run across the absorbent pad. Results were read after 15 minutes. The prevalence of HBV and HCV infection in 100 healthcare workers was determined by testing the plasma collected from the clients during their normal checkup using HBsAg and HCVAb test strips. Results were subjected to statistical analysis using chi-square test. The prevalence of HBV among HCWs was 19 out of 100 (19.0%) and that of HCV was 5 out of 100 (5.0%) where in both cases, higher prevalence was observed among female nurses. It was also observed that all HCV positive cases were recorded among nurses only. The study revealed that nurses are at greater risk of contracting HBV and HCV due to their frequent contact with patients. It is therefore recommended that effective vaccination and other infection control measures be encouraged among healthcare workers.

Keywords: prevalence, hepatitis, viruses, healthcare workers, infection

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Authors: Emmanuel Chibuogu Asogwa, Tochukwu Sunday Belonwu

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An urgent demand for creative solutions has been created by the rapid expansion of medical knowledge, the complexity of patient care, and the requirement for more precise decision-making. As a solution to this problem, the creation of a Medical Intelligent Process Model (MIPM) utilizing ontology-based appears as a promising way to overcome this obstacle and unleash the full potential of healthcare systems. The development of a Medical Intelligent Process Model (MIPM) using ontology-based techniques is motivated by a lack of quick access to relevant medical information and advanced tools for treatment planning and clinical decision-making, which ontology-based techniques can provide. The aim of this work is to develop a structured and knowledge-driven framework that leverages ontology, a formal representation of domain knowledge, to enhance various aspects of healthcare. Object-Oriented Analysis and Design Methodology (OOADM) were adopted in the design of the system as we desired to build a usable and evolvable application. For effective implementation of this work, we used the following materials/methods/tools: the medical dataset for the test of our model in this work was obtained from Kaggle. The ontology-based technique was used with Confusion Matrix, MySQL, Python, Hypertext Markup Language (HTML), Hypertext Preprocessor (PHP), Cascaded Style Sheet (CSS), JavaScript, Dreamweaver, and Fireworks. According to test results on the new system using Confusion Matrix, both the accuracy and overall effectiveness of the medical intelligent process significantly improved by 20% compared to the previous system. Therefore, using the model is recommended for healthcare professionals.

Keywords: ontology-based, model, database, OOADM, healthcare

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Authors: Fatima Faraz

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BACKGROUND: While Artificial intelligence (AI) provides new opportunities across a wide variety of industries, healthcare is no exception. AI can lead to advancements in how the healthcare system functions and improves the quality of patient care. Developing countries like Pakistan are lagging in the implementation of AI-based solutions in healthcare. This demands increased knowledge and AI literacy among health care professionals. OBJECTIVES: To assess the level of awareness among medical students and faculty about AI in preparation for teaching AI basics and data science applications in clinical practice in an integrated medical curriculum. METHODS: An online 15-question semi-structured questionnaire, previously tested and validated, was delivered among participants through convenience sampling. The questionnaire composed of 3 parts: participant’s background knowledge, AI awareness, and attitudes toward AI applications in medicine. RESULTS: A total of 182 students and 39 faculty members from Rawalpindi Medical University, Pakistan, participated in the study. Only 26% of students and 46.2% of faculty members responded that they were aware of AI topics in clinical medicine. The major source of AI knowledge was social media (35.7%) for students and professional talks and colleagues (43.6%) for faculty members. 23.5% of participants answered that they personally had a basic understanding of AI. Students and faculty (60.1%) were interested in AI in patient care and teaching domain. These findings parallel similar published AI survey results. CONCLUSION: This survey concludes interest among students and faculty in AI developments and technology applications in healthcare. Further studies are required in order to correctly fit AI in the integrated modular curriculum of medical education.

Keywords: medical education, data science, artificial intelligence, curriculum

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Authors: Sonia Butalia, Huong Luu, Alexis Guigue, Karen J. B. Martins, Khanh Vu, Scott W. Klarenbach

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Obesity-related health conditions impose a substantial economic burden on payers due to increased healthcare use. Estimates of healthcare resource use and costs associated with obesity-related comorbidities are needed to inform policies and interventions targeting these conditions. Methods: Adults living with obesity were identified (a procedure-related body mass index code for class 2/3 obesity between 2012 and 2019 in Alberta, Canada; excluding those with bariatric surgery), and outcomes were compared over 1-year (2019/2020) between those who had and did not have specific obesity-related comorbidities. The probability of using a healthcare service (based on the odds ratio of a zero [OR-zero] cost) was compared; 95% confidence intervals (CI) were reported. Logistic regression and a generalized linear model with log link and gamma distribution were used for total healthcare cost comparisons ($CDN); cost ratios and estimated cost differences (95% CI) were reported. Potential socio-demographic and clinical confounders were adjusted for, and incremental cost differences were representative of a referent case. Results: A total of 220,190 adults living with obesity were included; 44% had hypertension, 25% had osteoarthritis, 24% had type-2 diabetes, 17% had cardiovascular disease, 12% had insulin resistance, 9% had chronic back pain, and 4% of females had polycystic ovarian syndrome (PCOS). The probability of hospitalization, ED visit, and ambulatory care was higher in those with a following obesity-related comorbidity versus those without: chronic back pain (hospitalization: 1.8-times [OR-zero: 0.57 [0.55/0.59]] / ED visit: 1.9-times [OR-zero: 0.54 [0.53/0.56]] / ambulatory care visit: 2.4-times [OR-zero: 0.41 [0.40/0.43]]), cardiovascular disease (2.7-times [OR-zero: 0.37 [0.36/0.38]] / 1.9-times [OR-zero: 0.52 [0.51/0.53]] / 2.8-times [OR-zero: 0.36 [0.35/0.36]]), osteoarthritis (2.0-times [OR-zero: 0.51 [0.50/0.53]] / 1.4-times [OR-zero: 0.74 [0.73/0.76]] / 2.5-times [OR-zero: 0.40 [0.40/0.41]]), type-2 diabetes (1.9-times [OR-zero: 0.54 [0.52/0.55]] / 1.4-times [OR-zero: 0.72 [0.70/0.73]] / 2.1-times [OR-zero: 0.47 [0.46/0.47]]), hypertension (1.8-times [OR-zero: 0.56 [0.54/0.57]] / 1.3-times [OR-zero: 0.79 [0.77/0.80]] / 2.2-times [OR-zero: 0.46 [0.45/0.47]]), PCOS (not significant / 1.2-times [OR-zero: 0.83 [0.79/0.88]] / not significant), and insulin resistance (1.1-times [OR-zero: 0.88 [0.84/0.91]] / 1.1-times [OR-zero: 0.92 [0.89/0.94]] / 1.8-times [OR-zero: 0.56 [0.54/0.57]]). After fully adjusting for potential confounders, the total healthcare cost ratio was higher in those with a following obesity-related comorbidity versus those without: chronic back pain (1.54-times [1.51/1.56]), cardiovascular disease (1.45-times [1.43/1.47]), osteoarthritis (1.36-times [1.35/1.38]), type-2 diabetes (1.30-times [1.28/1.31]), hypertension (1.27-times [1.26/1.28]), PCOS (1.08-times [1.05/1.11]), and insulin resistance (1.03-times [1.01/1.04]). Conclusions: Adults with obesity who have specific disease-related health conditions have a higher probability of healthcare use and incur greater costs than those without specific comorbidities; incremental costs are larger when other obesity-related health conditions are not adjusted for. In a specific referent case, hypertension was costliest (44% had this condition with an additional annual cost of $715 [$678/$753]). If these findings hold for the Canadian population, hypertension in persons with obesity represents an estimated additional annual healthcare cost of $2.5 billion among adults living with obesity (based on an adult obesity rate of 26%). Results of this study can inform decision making on investment in interventions that are effective in treating obesity and its complications.

Keywords: administrative data, healthcare cost, obesity-related comorbidities, real world evidence

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Authors: Al Huuskonen, Clio Lake, K. M. Naude, Polina Petlitsyna, Sorsha Henning, Julia Wimmers-Klick

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This project presents the outcomes of a community-based participatory action initiative aimed at advocating for equitable healthcare and human rights for trans, two-spirit, and gender-diverse individuals, building upon the University of British Columbia (UBC) Trans Coalition's ongoing efforts. Participatory Action Research (PAR) was chosen as the research method with the goal of improving trans rights on the UBC campus, particularly regarding equitable access to healthcare. PAR involves active community contribution throughout the research process, which in this case was done by way of liaising with student resource groups and advocacy leaders. The goals of this project were as follows: a) identify gaps in gender-affirming healthcare for UBC students by consulting the community and collaborating with UBC services, b) develop an information package outlining provincial and university-based health insurance for gender-affirming care (including hormone therapy and surgeries), FAQs, and resources for UBC's trans students, c) make this package available to UBC students and other national transgender advocacy organizations. The initiative successfully expanded the UBC AMS Student Health and Dental Plan to include gender-affirming procedural coverage, developed a care access guide for students, and advocated for improved health records inclusivity, mechanisms for trans students to report negative care experiences, and increased access to gender-affirming primary care through the on-campus health clinic. Collaboration with other universities' pride organizations and Trans Care BC yielded positive outcomes through broader coalition building and resource sharing. Ongoing efforts are underway to update provincial policies, particularly through expanding coverage under fair pharma care and addressing the compounding effects of the primary care crisis for trans individuals. The project's tangible results include improved trans rights on campus, especially in terms of healthcare access. Expanding healthcare coverage through student care benefits thousands of students, making the ability to undergo important affirming procedures more affordable. Providing students with information on extended coverage options and communication with their doctors further removes barriers to care and positively impacts student wellbeing. This initiative demonstrates the effectiveness of community-based participatory action in advancing equitable healthcare for trans and gender-diverse individuals and serves as a model for other institutions and organizations striving to promote inclusivity and advocate for marginalized populations' rights.

Keywords: equitable healthcare, trans and gender-diverse individuals, inclusivity, participatory action research project

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Authors: Raphaël Weuts, Mykyta Petik, Anton Vedder

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Artificial Intelligence has the potential to create and already creates enormous value in healthcare. Prescriptive systems might be able to make the use of healthcare capacity more efficient. Such systems might entail interpretations that exclude the effect of confounders that brings risks with it. Those risks might be mitigated by regulation that prevents systems entailing such risks to come to market. One modality of regulation is that of legislation, and the European AI Act is an example of such a regulatory instrument that might mitigate these risks. To assess the risk mitigation potential of the AI Act for those risks, this research focusses on a case study of a hypothetical application of medical device software that entails the aforementioned risks. The AI Act refers to the harmonised norms for already existing legislation, here being the European medical device regulation. The issue at hand is a causal link between a confounder and the value the algorithm optimises for by proxy. The research identifies where the AI Act already looks at confounders (i.a. feedback loops in systems that continue to learn after being placed on the market). The research identifies where the current proposal by parliament leaves legal uncertainty on the necessity to check for confounders that do not influence the input of the system, when the system does not continue to learn after being placed on the market. The authors propose an amendment to article 15 of the AI Act that would require high-risk systems to be developed in such a way as to mitigate risks from those aforementioned confounders.

Keywords: AI Act, healthcare, confounders, risks

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Authors: Nizar Ghali, Bernard Fortin, Guy Lacroix

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In Quebec, colonoscopies volumes have continued to rise in recent years in the absence of effective monitoring mechanism for the appropriateness and the quality of these exams. In 2010, November, Quebec Government introduced the colorectal cancer-screening program in the objective to control for volume and cost imperfection. This program is based on clinical standards and was initiated for first group of institutions. One year later, Government adds financial incentives for participants institutions. In this analysis, we want to assess for the causal effect of the two components of this program: clinical pathways and financial incentives. Especially we assess for the reform effect on healthcare quality and population health in the context that medical remuneration is not directly dependent on this additional funding offered by the program. We have data on admissions episodes and deaths for 8 years. We use multistate model analog to difference in difference approach to estimate reform effect on the transition probability between different states for each patient. Our results show that the reform reduced length of stay without deterioration in hospital mortality or readmission rate. In the other hand, the program contributed to decrease the hospitalization rate and a less invasive treatment approach for colorectal surgeries. This is a sign of healthcare quality and population health improvement. We demonstrate in this analysis that physicians’ behavior can be affected by both clinical standards and financial incentives even if offered to facilities.

Keywords: multi-state and multi-episode transition model, healthcare quality, length of stay, transition probability, difference in difference

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Authors: Aykut Bedük, Kemalettin Eryeşil, Osman Eşmen

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The aim of this study is to examine the relationship between organizational commitment which is defined as a strong belief in and acceptance of the organization’s goals and values, and burnout syndrome and organizational cynicism. Accordingly, a field research based on survey method was conducted on the employees of a health institution operating in the province of Konya. The findings of the research show that there is a positive statistically significant relationship between organizational cynicism and burnout while there is a negative statistically significant relationship between organizational commitment and burnout. Furthermore, it has been also realized that there is a negative and statistically significant relationship between organizational commitment and organizational cynicism.

Keywords: burnout, organizational commitment, organizational cynicism, healthcare management

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Authors: Caja Thimm

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Already well before the Corona pandemic hit the world, ‘fake news‘ were no longer regarded as harmless twists of the truth but as intentionally composed disinformation, often with the goal of manipulative populist propaganda. During the Corona crisis, particularly conspiracy narratives have become a worldwide phenomenon with dangerous consequences (anti vaccination myths). The success of these manipulated news need s to be counteracted by trustworthy news, which in Europe particularly includes public broadcasting media and their social media channels. To understand better how the main public broadcasters in Germany, the UK, and France used Instagram strategically, a comparative study was carried out. The study – comparative analysis of Instagram during the Corona Crisis In our empirical study, we compared the activities by selected formats during the Corona crisis in order to see how the public broadcasters reached their audiences and how this might, in the longer run, affect journalistic strategies on social media platforms. First analysis showed that the increase in the use of social media overall was striking. Almost one in two adult online users (48 %) obtained information about the virus in social media, and in total, 38% of the younger age group (18-24) looked for Covid19 information on Instagram, so the platform can be regarded as one of the central digital spaces for Corona related information searches. Quantitative measures showed that 47% of recent posts by the broadcasters were related to Corona, and 7% treated conspiracy myths. For the more detailed content analysis, the following categories of analysis were applied: • Digital storytelling and instastories • Textuality and semantic keys • links to information • stickers • videochat • fact checking • news ticker • service • infografics and animated tables Additionally to these basic features, we particularly looked for new formats created during the crisis. Journalistic use of social media platforms opens up immediate and creative ways of applying the media logics of the respective platforms, and particularly the BBC and ARD formats proved to be interactive, responsive, and entertaining. Among them were new formats such as a space for user questions and personal uploads, interviews, music, comedy, etc. Particularly the fact checking channel got a lot of attention, as many user questions were focused on the conspiracy theories, which dominated the public discourse during many weeks in 2020. In the presentation, we will introduce eight particular strategies that show how public broadcasting journalism can adopt digital platforms and use them creatively and, hence help to counteract against conspiracy narratives and fake news.

Keywords: fake news, social media, digital journalism, digital methods

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Authors: Shu-Ching Chiu, Shu-Fang Chang

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The World Health Organization (WHO) has been actively developing intervention programs to deal with geriatric frailty. In its White Paper on Healthcare Policy 2020, the Department of Health, Bureau of Health Promotion proposed that active aging and the prevention of disability are essential for elderly people to maintain good health. The paper recommended five main policies relevant to this objective, one of which is the prevention of frailty and disability. Scholars have proposed a number of different criteria to diagnose and assess frailty; no consistent or normative standard of measurement is currently available. In addition, many methods of assessment are recursive, which can easily result in recall bias. Due to the relationship between frailty and physical fitness with regard to co-morbidity, it is important that academics optimize the criteria used to assess frailty by objectively evaluating the physical fitness of senior citizens. This study used a review of the literature to identify fitness indicators suitable for measuring frailty in the elderly. This study recommends that measurement criteria be integrated to produce an optimized predictive value for frailty score. Healthcare professionals could use this data to detect frailty at an early stage and provide appropriate care to prevent further debilitation and increase longevity.

Keywords: frailty, aging, physical fitness, optimized criteria, healthcare

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Authors: Hilal Al Shamsi, Abdullah Almutairi

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Introduction: As primary healthcare centres play an important role in implementing Saudi Arabia’s health strategy, this paper offers a review of publications on the quality of the country’s primary health care. With the aim of deciding on solutions for improvement, it provides an overview of healthcare quality in this context and indicates barriers to quality. Method: Using two databases, ProQuest and Scopus, data extracted from published articles were systematically analysed for determining the care quality in Saudi primary health centres and obstacles to achieving higher quality. Results: Twenty-six articles met the criteria for inclusion in this review. The components of healthcare quality were examined in terms of the access to and effectiveness of interpersonal and clinical care. Good access and effective care were identified in such areas as maternal health care and the control of epidemic diseases, whereas poor access and effectiveness of care were shown for chronic disease management programmes, referral patterns (in terms of referral letters and feedback reports), health education and interpersonal care (in terms of language barriers). Several factors were identified as barriers to high-quality care. These included problems with evidence-based practice implementation, professional development, the use of referrals to secondary care and organisational culture. Successful improvements have been implemented by other systems, such as mobile medical units, electronic referrals, online translation tools and mobile devices and their applications; these can be implemented in Saudi Arabia for improving the quality of the primary healthcare system in this country. Conclusion: The quality of primary health care in Saudi Arabia varies among the different services. To improve quality, management programmes and organisational culture must be promoted in primary health care. Professional development strategies are also needed for improving the skills and knowledge of healthcare professionals. Potential improvements can be implemented to improve the quality of the primary health system.

Keywords: quality, primary health care, Saudi Arabia, health centres, general medical

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Authors: Maria De Los Angeles Rodriguez Cadena

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This paper discusses how the fictional versions of women of the past contribute to advance today’s ideas of social justice, personal freedom and emancipation as well as to highlight the creative challenge of constructing people and events on fictional narratives on television that incorporate multiple and simultaneous layers of meaning and complexity. This project builds on existing scholarship on audiovisual texts by exploring an influential but under-studied director. In two Mexican television series, Patricia Arriaga Jordan, an award-winning television producer, scriptwriter and director, constructs the life of two outstanding women that have played an influential role in national history and captured Mexican’s popular imagination for generations: Sor Juana Inés de la Cruz, and Malinche. Malinche (2018) tells the story of an extraordinary indigenous woman, Malintzin, during the Spanish Conquest (1511-1550) that is considered to have played a key role in the fall of the Aztec empire by acting as translator, negotiator and cultural mediator for the Spanish conquerors. Juana Ines (2016) portrays Sor Juana, a poet, essayist, playwright, theologian, philosopher, nun, of XVII century colonial Mexico, one of the brightest minds of her time, and now recognized as the first feminist of the Americas who wrote on the rights of women to an education, religious authority and feminist advocacy. Both series, as fictional narratives that recreate defining historical periods, specific events and relevant characters in the History of Mexico can be read as an example of what is called texts of cultural memory. A cultural memory text is a narrative that bonds the concepts of history, identity and belonging, and that is realized and disseminated through symbolic systems such as written documents, visual images, and dramatic representation. Cultural memory, through its narratives of historical fiction, emphasizes memory processes (historiography) and its implications and artifacts (cultural memory) mainly through the medial frameworks of remembering, which are the medial process by which memories (narratives, documents) participate in public knowledge and become collective memory. Historical fiction on television not only creates a portrayal of the past related to the real lives of protagonists, but it also significantly contributes to understand the past as an ever-evolving entity that highlights both, the necessary connection with the present as part of a developing sense of collective identity and belonging, as well as the relevance of the medium in which the past is represented and that ultimately supports the process of historical awareness. Through the emblematic recreation of national heroines and historical events in the unique context of historical drama on television, those texts constitute a venue where concepts of the past and the traditionally established ideas about history and heroines are highlighted, questioned and transformed.

Keywords: cultural memory, historical fiction, Mexico, television, women directors

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Authors: Manal Sultan Alhussein, Xiang Michelle Liu

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Telehealth is an advanced technology using digital information and telecommunication facilities that provide access to health services from a distance. It slows the transmission factor of COVID-19, especially for elderly patients and patients with chronic diseases during the pandemic. Therefore, understanding patient perspectives on telehealth services and the factors impacting their option of telehealth service will shed light on the measures that healthcare providers can take to improve the quality of telehealth services. This study aimed to evaluate perceptions of telehealth services among different patient groups and explore various aspects of telehealth utilization in the United States during the COVID-19 pandemic. An online survey distributed via social media platforms was used to collect research data. In addition to the descriptive statistics, both correlation and regression analyses were conducted to test research hypotheses. The empirical results highlighted that the factors such as accessibility to telehealth services and the type of specialty clinics that the patients required play important roles in the effectiveness of telehealth services they received. However, the results found that patients’ waiting time to receive telehealth services and their annual income did not significantly influence their desire to select receiving healthcare services via telehealth. The limitations of the study and future research directions are discussed.

Keywords: telehealth, patient satisfaction, pandemic, healthcare, survey

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Authors: Arvind Aggarwal

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We have developed a comprehensive global healthcare delivery System based on information technology. It has medical consultation system where a virtual consultant can give medical consultation to the patients and Doctors at the digital medical centre after reviewing the patient’s EMR file consisting of patient’s history, investigations in the voice, images and data format. The system has the surgical operation system too, where a remote robotic consultant can conduct surgery at the robotic surgical centre. The instant speech and text translation is incorporated in the software where the patient’s speech and text (language) can be translated into the consultant’s language and vice versa. A consultant of any specialty (surgeon or Physician) based in any country can provide instant health care consultation, to any patient in any country without loss of time. Robotic surgeons based in any country in a tertiary care hospital can perform remote robotic surgery, through patient friendly telemedicine and tele-surgical centres. The patient EMR, financial data and data of all the consultants and robotic surgeons shall be stored in cloud. It is a complete comprehensive business model with healthcare medical and surgical delivery system. The whole system is self-financing and can be implemented in any country. The entire system uses paperless, filmless techniques. This eliminates the use of all consumables thereby reduces substantial cost which is incurred by consumables. The consultants receive virtual patients, in the form of EMR, thus the consultant saves time and expense to travel to the hospital to see the patients. The consultant gets electronic file ready for reporting & diagnosis. Hence time spent on the physical examination of the patient is saved, the consultant can, therefore, spend quality time in studying the EMR/virtual patient and give his instant advice. The time consumed per patient is reduced and therefore can see more number of patients, the cost of the consultation per patients is therefore reduced. The additional productivity of the consultants can be channelized to serve rural patients devoid of doctors.

Keywords: e-health, telemedicine, telecare, IT-based healthcare

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Authors: Veronika Solopova, Oana-Iuliana Popescu, Tim Landgraf, Christoph Benzmüller

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Beginning in 2014, slowly building geopolitical tensions in Eastern Europe led to a full-blown conflict between the Russian Federation and Ukraine that generated an unprecedented amount of news articles and data from social media data, reflecting the opposing ideologies and narratives as a background and the essence of the ongoing war. These polarized informational campaigns have led to countless mutual accusations of misinformation and fake news, shaping an atmosphere of confusion and mistrust for many readers all over the world. In this study, we analyzed scraped news articles from Ukrainian, Russian, Romanian and English-speaking news outlets, on the eve of 24th of February 2022, compared to day five of the conflict (28th of February), to see how the media influenced and mirrored the changes in public opinion. We also contrast the sources opposing and supporting the stands of the Russian government in Ukrainian, Russian and Romanian media spaces. In a data-driven way, we describe how the narratives are spread throughout Eastern and Central Europe. We present predictive linguistic features surrounding war propaganda. Our results indicate that there are strong similarities in terms of rhetoric strategies in the pro-Kremlin media in both Ukraine and Russia, which, while being relatively neutral according to surface structure, use aggressive vocabulary. This suggests that automatic propaganda identification systems have to be tailored for each new case, as they have to rely on situationally specific words. Both Ukrainian and Russian outlets lean towards strongly opinionated news, pointing towards the use of war propaganda in order to achieve strategic goals.

Keywords: linguistic, news, propaganda, Russia, ukraine

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Authors: Elizabeta Krstić Vukelja

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Digitization of personal data is a consequence of the development of information and communication technologies that create a new work environment with many advantages and challenges, but also potential threats to privacy and personal data protection. Regulation (EU) 2016/679 of the European Parliament and of the Council is becoming a law and obligation that should address the issues of personal data protection and information security. The existence of the Regulation leads to the conclusion that national legislation in the field of virtual environment, protection of the rights of EU citizens and processing of their personal data is insufficiently effective. In the health system, special emphasis is placed on the processing of special categories of personal data, such as health data. The healthcare industry is recognized as a particularly sensitive area in which a large amount of medical data is processed, the digitization of which enables quick access and quick identification of the health insured. The protection of the individual requires quality IT solutions that guarantee the technical protection of personal categories. However, the real problems are the technical and human nature and the spatial limitations of the application of the Regulation. Some conclusions will be drawn by analyzing the implementation of the basic principles of the Regulation on the example of the Croatian health care system and comparing it with similar activities in other EU member states.

Keywords: regulation, healthcare system, personal dana protection, quality data assurance

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Authors: Sibusiso Buthelezi, Rugira Regis Marie-Modeste, Deliwe Rene Phetlhu

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Introduction: Mother-to-child transmission persists owing to inadequate implementation of prevention of mother-to-child transmission programmes, particularly in rural areas. To achieve a target of zero new HIV infection in children born from women living with HIV, the involvement of mothers and caregivers is undeniable. Therefore, there is a need to explore the views of the mothers because of the role they play in their own right when it comes to preventing their children from contracting HIV by consistently adhering to the guidelines of the prevention of mother-to-child transmission programme. Thus, this study sought to explore and describe the perceptions of mothers on their role in the prevention of HIV to their children exposed to HIV and further explore their perceptions of the childcare received in the healthcare facility. Methods: The study was conducted in November-December 2019 in Ngaka Modiri Molema in North West Province in South Africa. A qualitative exploratory, descriptive research design was used. Purposive sampling was used to select the mothers of children exposed to HIV during the mother`s clinic attendance. Data collection was done through semi-structured individual interviews with mothers of children exposed to HIV. Colaizzi`s method of data analysis was used to analyse data in this study. Results: Seven themes emerged from data analysis, namely: health benefits from coming to the healthcare facility, communication, information needs, attitude of healthcare workers, healthcare administration system, the role of a mother, and disclosure of HIV status. Conclusion: This study revealed systematic gaps that exist in the programme, which hinder the childcare services of children exposed to HIV and socio-economically related hindrances. Mothers’ roles, such as exclusive breastfeeding, taking their own medication, and child follow-up visits, remain inadequate. The study findings show that there is a need to develop a contextual-tailored intervention strategy that would improve the implementation of prevention of mother-to-child transmission in rural areas.

Keywords: children exposed to HIV, mothers’ role to prevent MTCT, mothers’ perceptions on childcare, PMTCT in rural areas

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Authors: Arun Kumar, Neelesh Haulder

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This paper identifies and resolves some key issues relating to a specific aspect within the supply chain logistics of the public health care industry in the Republic of Mauritius. The analysis and the proposed solution are performed using soft systems methodology (SSM). Through the application of this relevant systematic approach at problem solving, the aim is to obtain an in-depth analysis of the problem, incorporating every possible world view of the problem and consequently to obtain a well explored solution aimed at implementing relevant changes within the current supply chain logistics of the health care industry, with the purpose of tackling the key identified issues.

Keywords: soft systems methodology, CATWOE, healthcare, logistics

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Authors: Sonia Butalia, Huong Luu, Alexis Guigue, Karen J. B. Martins, Khanh Vu, Scott W. Klarenbach

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Obesity is associated with significant personal impacts on health and has a substantial economic burden on payers due to increased healthcare use. A contemporary estimate of the healthcare costs associated with obesity at the population level are lacking. This evidence may provide further rationale for weight management strategies. Methods: Adults who underwent a medical procedure between 2012 and 2019 in Alberta, Canada were categorized into the investigational cohort (had body mass index [BMI]-defined class 2 or 3 obesity based on a procedure-associated code) and the control cohort (did not have the BMI procedure-associated code); those who had bariatric surgery were excluded. Characteristics were presented and healthcare costs ($CDN) determined over a 1-year observation period (2019/2020). Logistic regression and a generalized linear model with log link and gamma distribution were used to assess total healthcare costs (comprised of hospitalizations, emergency department visits, ambulatory care visits, physician visits, and outpatient prescription drugs); potential confounders included age, sex, region of residence, and whether the medical procedure was performed within 6-months before the observation period in the partial adjustment, and also the type of procedure performed, socioeconomic status, Charlson Comorbidity Index (CCI), and seven obesity-related health conditions in the full adjustment. Cost ratios and estimated cost differences with 95% confidence intervals (CI) were reported; incremental cost differences within the adjusted models represent referent cases. Results: The investigational cohort (n=220,190) was older (mean age: 53 standard deviation [SD]±17 vs 50 SD±17 years), had more females (71% vs 57%), lived in rural areas to a greater extent (20% vs 14%), experienced a higher overall burden of disease (CCI: 0.6 SD±1.3 vs 0.3 SD±0.9), and were less socioeconomically well-off (material/social deprivation was lower [14%/14%] in the most well-off quintile vs 20%/19%) compared with controls (n=1,955,548). Unadjusted total healthcare costs were estimated to be 1.77-times (95% CI: 1.76, 1.78) higher in the investigational versus control cohort; each healthcare resource contributed to the higher cost ratio. After adjusting for potential confounders, the total healthcare cost ratio decreased, but remained higher in the investigational versus control cohort (partial adjustment: 1.57 [95% CI: 1.57, 1.58]; full adjustment: 1.21 [95% CI: 1.20, 1.21]); each healthcare resource contributed to the higher cost ratio. Among urban-dwelling 50-year old females who previously had non-operative procedures, no procedures performed within 6-months before the observation period, a social deprivation index score of 3, a CCI score of 0.32, and no history of select obesity-related health conditions, the predicted cost difference between those living with and without obesity was $386 (95% CI: $376, $397). Conclusions: If these findings hold for the Canadian population, one would expect an estimated additional $3.0 billion per year in healthcare costs nationally related to BMI-defined obesity (based on an adult obesity rate of 26% and an estimated annual incremental cost of $386 [21%]); incremental costs are higher when obesity-related health conditions are not adjusted for. Results of this study provide additional rationale for investment in interventions that are effective in preventing and treating obesity and its complications.

Keywords: administrative data, body mass index-defined obesity, healthcare cost, real world evidence

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Authors: Umamaheswari Shanmugam, Silvia Ronchi

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Software, artificial intelligence, and machine learning can improve healthcare through innovative and advanced technologies that can use the large amount and variety of data generated during healthcare services every day; one of the significant advantages of these new technologies is the ability to get experience and knowledge from real-world use and to improve their performance continuously. Healthcare systems and institutions can significantly benefit because the use of advanced technologies improves the efficiency and efficacy of healthcare. Software-defined as a medical device, is stand-alone software that is intended to be used for patients for one or more of these specific medical intended uses: - diagnosis, prevention, monitoring, prediction, prognosis, treatment or alleviation of a disease, any other health conditions, replacing or modifying any part of a physiological or pathological process–manage the received information from in vitro specimens derived from the human samples (body) and without principal main action of its principal intended use by pharmacological, immunological or metabolic definition. Software qualified as medical devices must comply with the general safety and performance requirements applicable to medical devices. These requirements are necessary to ensure high performance and quality and protect patients' safety. The evolution and the continuous improvement of software used in healthcare must consider the increase in regulatory requirements, which are becoming more complex in each market. The gap between these advanced technologies and the new regulations is the biggest challenge for medical device manufacturers. Regulatory requirements can be considered a market barrier, as they can delay or obstacle the device's approval. Still, they are necessary to ensure performance, quality, and safety. At the same time, they can be a business opportunity if the manufacturer can define the appropriate regulatory strategy in advance. The abstract will provide an overview of the current regulatory framework, the evolution of the international requirements, and the standards applicable to medical device software in the potential market all over the world.

Keywords: artificial intelligence, machine learning, SaMD, regulatory, clinical evaluation, classification, international requirements, MDR, 510k, PMA, IMDRF, cyber security, health care systems

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