Innovative Medical Technologies Research Articles

Життєстійкість та рівень якості життя пацієнтів з НАЖХП: пілотне дослідження

Background. The prevalence of NAFLD in the general population is approximately 20-30% in Western countries and 5-18% in Asia. NAFLD consists of a range of liver diseases, ranging from simple deposition of fat in the liver (steatosis; called nonalcoholic fatty liver or NAFLD) to steatosis with associated hepatocyte lesions (NASH). Importantly, NASH, in turn, can lead to fibrosis, cirrhosis, and, in some cases, hepatocellular carcinoma (HCC). The aim of the study. The purpose of the study: to increase the effectiveness of treatment of patients with non-alcoholic fatty liver disease by optimizing lifestyle with psycho-corrective effects. Research methods. The study is conducted based on the gastroenterology department of the Center for Innovative Medical Technologies of the National Academy of Sciences of Ukraine. As of September 2021, a total of 23 patients with the non-alcoholic fatty liver disease aged 37 to 58 years (mean age 46.5 years) were examined, including 11 men (47.8%) and 12 women (52.2%). The initial survey and testing of patients are carried out on days 1-3 of admission to the hospital. The following methods were used in the study: "10 words" by AR Luria, Schulte tables, SRRS (Holmes and Ray scale), S. Muddy's vitality questionnaire, modified by D.A. Leontieva, SF-36 (Medical Outcomes Study Short Form). Results. In all interviewed patients, the level of cognitive functioning was at a satisfactory level. The level of both the actual viability and its subscale in most respondents was within the average. All respondents, without exception, had a moderate risk of developing the disease due to life events, which is of some concern. However, further research is likely to provide more information and an opportunity to confirm or refute the hypothesis formed at this stage of the study. According to the results of the assessment of the quality of life of patients, slightly less than half of the respondents (47.8%) have a reduced level of quality of life. Conclusions. The results presented in the article are another confirmation of the relevance and necessity of research aimed at identifying influencing factors and means to improve quality of life and the formation of a healthy internal picture of the disease of patients with non-alcoholic fatty liver disease.

Using health technology assessment to set priority, inform target product profiles, and design clinical study for health innovation

Early health technology assessment (early HTA) is a useful tool in guiding the innovation development process in medical technology development. However, the application of early HTA is sub-optimal amongst research and development (R&D) communities due to several challenges. In this paper, we presented a case study of application of early HTA by drawing on the experience from a workshop conducted for the Singapore government's medical technology innovation agency. The framework developed can help maximise the chance of the newly developed technology being accepted and widely used. By providing step-by-step guidance, this work aims to translate early HTA into a practical tool and promote the application of early HTA amongst R&D communities.

Innovation Resistance and Resource Allocation Strategy of Medical Information Digitalization

Healthcare industries are facing an enormous flow of medical records due to the progression of information technology and the trend of digital transformation. Thus, medical information digitalization is a huge digital dataset that can be utilized to benefit healthcare systems and patients. While many studies focus on the application of the digitalized medical information in the healthcare field, only a few mentioned its resistance. The theoretical background depicts a comprehensive overview of medical information digitalization and the barriers in previous literature. This study emphasized the interaction of medical information digitalization barriers and applies the importance-resistance analysis model (IRA) to identify the resistant factors overcoming strategy. It also clarifies the pathway to eliminating the innovation resistance and reveals the interaction of medical information digitalization barriers. The acquisition, management, and application of medical information digitalization are the key foundation of medical technology innovation, digital transformation, and the application of artificial intelligence. This work can reduce the limitation of a narrow healthcare context. This study helps healthcare industries to clarify and solve barriers and realizes the innovation and application of medical information digitalization. In the long term, the results provide a basis for the future development direction of medical information digitalization and affect the medical industry.

Mining the Data Oceans, Profiting on the Margins

AbstractAmerican capitalist medicine has produced a national healthcare system that is the most expensive – and producing the worse outcomes for patients – in the world. For many patients, social inequities and racial disparities embedded throughout the US healthcare system have only deepened and intensified over the last two decades, with very few realizing the promises made by medical technological innovation. Healthcare policy makers are turning to ‘data‐driven healthcare’ as a solution to these endemic problems. Yet the promise that digital technologies and data analytics will solve some of the most vexing questions in medical science, and will make healthcare more accessible, affordable, and equitable, in fact, hides the ongoing, structural inequities and injustices in health care.

The economic prerequisites of implementation of innovative technologies of mass-spectrometry in diagnostic of bacterial infections

The article presents the results of clinical economical analysis, based on "cost-effectiveness" technology, of MALDI-TOF MS, innovative medical technology of express identification of microorganisms, calculation of incremental indicator and application of notion "willingness-to-pay-threshold". Due to the extension of sanctions against the Russian Federation, this medical equipment for national laboratories becomes difficult to access and expensive, that conditions necessity to scientifically substantiate economical effectiveness of implementation of expensive innovative MALDI-TOF MS technology as instrument to contain global antibiotic resistance increase. The understanding of importance of express identification of microorganisms as well as other positive effects that can be achieved by using modern medical equipment on the basis of mass spectrometry results in improving medical care quality, increasing reputation level of medical institution, greater commitment of physicians and patients to microbiological analysis with purpose of prescription of rational antibiotic therapy and improving population health.

Strategic Intellectual Property Management and spin offs during Medical Device Innovation and commercialisation

Intellectual Property (IP) protection for medical technology innovations is a milestone, generally undermined by Start-ups. Effective and timely IP protection acts as a lifeline for entrepreneurs/start-ups as it not only helps them attract investments and get competitive advantage but also enables marketing tie-ups and potential acquisition by larger companies. This article delineates the strategies for effective IP protection during different phases of technology development to enable medical technology innovators unlock IP potential of their innovations thereby gain competitive edge as well as reap financial rewards. Some interesting case studies and experience sharing by entrepreneurs have also been included for empirical understanding and to serve as practical tools for innovators working in medical device innovation space.

Pediatric Pain from Hypodermic Needles: History, Causes and Increasing the Efficacy of Pain Mitigation

Venous access is one of the most innovative and effective medical technologies developed. It provides the ability to deliver medications that are distributed quickly throughout the body, while blood analysis is one of the primary diagnostic tools used by physicians. Hypodermic venipuncture is as vital as it is commonplace, but is a procedure of a particularly distressing nature for young patients. An inability to accurately track developing pediatric anatomy and the incomplete neurological development of younger patients results in a challenging environment for the clinicians and an often traumatic and painful one for the young patients. Although there have been methods suggested to mitigate these challenges, a safe and reliably effective solution has not been found or established as a patient standard of care. This review will cover the evolution and purpose of the procedure, considerations for pediatric physiological variations and current pain reduction methods. Finally, a high efficacy mitigation technique will be proposed, utilizing current neurological understanding based on primary literature sources.

Assessment of Awareness and Experience of Using off-label Drugs by Doctors of Clinical Specialties.

Aim To evaluate the frequency of off-label prescription of medicines in practice of clinical specialists and the awareness of respondents of the procedure of justified off-label prescription.Material and methods The sample included 542 clinical specialists who worked in definite medical organizations in 26 entities of the Russian Federation. The respondents were proposed to fill in remotely an anonymous questionnaire to evaluate the experience of prescribing medicines off-label to adult patients.Results Prescribing medicines not in consistence with the officially approved instruction for medical use (off-label or "outside instruction") is a relevant issue of global medical care since convincing scientific evidence for safety of such use is scarce. Analysis of information about off-label prescription is one of current tasks of national medical research centers according to the Federal Project "Development of a network of national medical research centers and implementation of innovative medical technologies". According to the responses about the frequency of off-label prescriptions 67.5 % of respondents reported of no experience of off-label prescription, 27.7 % said "rarely" or "sometimes", and 4.8 % said "frequently" and "very frequently". Specialties of physicians who have more often used medicines off-label (50% and more) included obstetrics and gynecology, pediatrics, rheumatology, hematology, and pulmonology. Cardiologists, neurologists and clinical pharmacologists use medicines off-label relatively rarely (19.6%, 28.6 %, and 22.2 %, respectively). 40 % of medicines used off-label were those designed for the treatment of coronavirus infection SARS-CoV-2. The medicines most frequently used off-label included metformin, rituximab, and thioctic acid. 65 % of respondents assessed their knowledge of off-label prescription as insufficient. In addition, 75 % of respondents consider it useful to receive additional information about risks and benefits of off-label prescription in clinical practice.Conclusion The survey revealed the need of physicians for information about risks of the off-label use of medicines in clinical practice.

The hospital telemedicine TELEMED database: Providing information on evidence-based telemedicine services to hospital managers and healthcare professionals

Background Increased use of telemedicine in the healthcare system is a political goal in Denmark. Although the number of hospital patients using interventions such as the video consultation has increased in recent years only a small proportion of the outpatient and inpatient visits involve telemedicine. The TELEMED database (https://telemedicine.cimt.dk/) has been launched at the Center for Innovative Medical Technology in Denmark to ensure that hospital managers and healthcare professionals have access to information about telemedicine services and their effectiveness. This article describes the development and the content of the TELEMED database. Methods A structured literature search was made in the PubMed Database for randomised controlled trials or observational studies with a control group that investigated the effect of telemedicine interventions for hospital patients. Data were extracted from each article on the clinical effectiveness, patient perceptions, economic effects and implementation challenges. As the database should only provide inspiration to healthcare professionals regarding possibilities for use of telemedicine, the risk of bias in the studies was not assessed. Results The literature search resulted in 2825 hits. Based on full text assessment, 331 articles were included for data extraction and assessment. These articles present telemedicine services used in 22 different medical specialities. Forty-eight percent of the studies found a positive, statistically significant clinical effect, while 47% showed no statistically significant difference. In 48% of the studies, patients’ experiences were examined and of these 68% found positive patient experiences. Fifty-four percent of the articles included information on the economic effects and, of these, 51% found reduction in healthcare utilization. In the majority of studies between two and four types of implementation challenges were found. Conclusions and recommendations: The TELEMED database provides an easily accessible overview of existing evidence-based telemedicine services for use by hospital managers and health professionals, who whish to to implement telemedicine. The database is freely available and expected to be continuously improved and broadened over time.

Mammalian enteral ventilation ameliorates respiratory failure

Several aquatic organisms such as loaches have evolved unique intestinal breathing mechanisms to survive under extensive hypoxia. To date, it is highly controversial whether such capability can be adapted in mammalian species as another site for gas exchange. Here, we report the advent of the intestinal breathing phenomenon in mammalians by exploiting EVA (enteral ventilation via anus). Two different modes of EVA were investigated in an experimental model of respiratory failure: intra-rectal oxygen O2 gas ventilation (g-EVA) or liquid ventilation (l-EVA) with oxygenated perfluorocarbon. After induction of type 1 respiratory failure, we analyzed the effectiveness of g-EVA and I-EVA in mouse and pig, followed by preclinical safety analysis in rat. Both intra-rectal O2 gas and oxygenated liquid delivery were shown to provide vital rescue of experimental models of respiratory failure, improving survival, behavior, and systemic O2 level. A rodent and porcine model study confirmed the tolerable and repeatable features of an enema-like l-EVA procedure with no major signs of complications. EVA has proven effective in mammalians such that it oxygenated systemic circulation and ameliorated respiratory failure. Due to the proven safety of perfluorochemicals in clinics, EVA potentially provides an adjunctive means of oxygenation for patients under respiratory distress conditions. This work is funded by the Research Program on Emerging and Re-emerging Infectious Diseases, Research Projects on COVID-19 (JP20fk0108278, 20fk0108506h0001), from the Japan Agency for Medical Research and Development (AMED), to T.T.; Strategic Promotion for Practical Application of Innovative Medical Technology, Seeds A (A145), to T.T.; and KAKENHI 19K22657, to T.C.-Y. This research is partially supported by the AMED Translational Research Program; Strategic Promotion for Practical Application of Innovative Medical Technology (TR-SPRINT), to T.C.-Y.; and AMED JP18bm0704025h0001 (Program for Technological Innovation of Regenerative Medicine), to T.T.

Innovative Medical Technology and the Treatment Decision-Making Process in Multiple Sclerosis: A Focus Group Study to Examine Patient Perspectives.

BackgroundDisease-modifying therapies are given to people with multiple sclerosis (MS) to reduce disease progression and relapse frequency. Current modes of administration include oral, injectable and infusion therapy and the treatment decision-making process is complex. A novel mode of treatment administration, an implantable device, is currently under development, yet patient attitudes about the device are unknown. The aim of this study was 1) to understand the treatment decision-making process from the patient perspective and 2) to explore the possible acceptance of an implant to treat MS.MethodsFocus groups with people with MS were conducted in the Netherlands. Three topics were addressed: the treatment decision-making process, the current treatment landscape, and attitudes about the implantable device. All focus groups were recorded and transcribed and data were analyzed by raw data coding and creating themes. An online survey was conducted in the Netherlands to quantify interest in an implant.ResultsTwo focus group sessions were held (n=16 participants) and n=93 persons filled out the survey. The main theme that emerged was the constant uncertainty persons with MS face throughout their disease course and during treatment decisions (when to start, stop, continue or switch treatment). Patients were generally positive towards the implant but felt that efficacy and safety should be guaranteed.ConclusionPeople with MS want some form of control over their disease and treatment course. New medical technologies, such as an implant, may enhance the treatment landscape and with caution we postulate that it may be accepted by patients as a new mode of administration, though further research is needed. For medical technologies to be successful, patients should be engaged early on in the design process.

Main approaches to treatment of hypoxia in acute respiratory distress syndrome, bacterial and viral pneumonia (part II)

The paper summarizes data on modern approaches to the diagnosis, prevention and treatment of severe acute parenchymal respiratory failure of various origins, including ARDS due to bacterial viral pneumonia. The work is based on the data of modern well-organized studies, analysis of international clinical guidelines with a high degree of evidence, as well as the results of our own long-term experimental studies and clinical observations of the treatment of patients with ARDS of various origins, including viral pneumonia of 2009, 2016, 2020. Scientifically grounded algorithms for prevention, differential diagnosis and personalized therapy of severe acute respiratory failure using innovative medical technologies and a wide range of respiratory and adjuvant treatment methods have been formulated. The authors tried to adapt as much as possible the existing current recommendations for the daily clinical practice of anesthesiologists and resuscitators.

Main approaches to treatment of hypoxia in acute respiratory distress syndrome, bacterial and viral pneumonia (part III)

The paper summarizes data on modern approaches to the diagnosis, prevention and treatment of severe acute parenchymal respiratory failure of various origins, including ARDS due to bacterial viral pneumonia. The work is based on the data of modern well-organized studies, analysis of international clinical guidelines with a high degree of evidence, as well as the results of our own long-term experimental studies and clinical observations of the treatment of patients with ARDS of various origins, including viral pneumonia of 2009, 2016, 2020. Scientifically grounded algorithms for prevention, differential diagnosis and personalized therapy of severe acute respiratory failure using innovative medical technologies and a wide range of respiratory and adjuvant treatment methods have been formulated. The authors tried to adapt as much as possible the existing current recommendations for the daily clinical practice of anesthesiologists and resuscitators.

Amino Acid Formulas in Patients with Gastrointestinal Diseases

Modern approaches for the management of children with gastrointestinal pathologies include optimal nutritional support that makes it possible to replete energy failure and restore essential nutrients balance. The article presents key information on gastrointestinal diseases in which modern amino acid formulas can be used to regulate nutritional status. The authors have conducted the extensive analysis of all available for now evidence on the efficacy, safety and utility of using such innovative medical technology as special elemental formula in gastrointestinal tract pathological conditions. This material is the basis for guidlines on the use of amino acid formulas developed by expert specialists of the Union of Pediatricians of Russia in 2020.

DIRECTIONS OF THE STATE POLICY OF HEALTHCARE REFORM IN UKRAINE

Today in Ukraine, the theme of health care is extremely relevant and painful for most Ukrainian society. The Ukrainian healthcare system has a low level of financial and material security, a technically backward infrastructure, imperfect management, requires significant financial investments, and the use of innovative management and medical technologies that the state cannot provide due to the crisis and limited budget. Therefore, the topic of health care is one of the most discussed in society, because health care concerns everyone without exception, a citizen of our state, which is why the process of formation and implementation of state policy in the field of health today is almost the most important issue in Ukraine. In view of this, the article analyzes the state of the healthcare system of Ukraine, the current state policy of Ukraine in the field of health care. The features and drawbacks of the modern healthcare system of Ukraine, the difficulties faced by the state in the process of reforming the healthcare system are highlighted. The necessity of changing the existing healthcare system as a prerequisite for the following changes in this area, the preconditions of European integration development of Ukraine, achievement of modern health standards, based on the current realities of Ukraine's existence, national interests, ongoing system changes in Ukraine, as well as needs state and society. The directions of the state policy of healthcare reform in Ukraine have been determined, and it has been proved that the reform of the medical sphere requires significant changes in the socio-political, financial-economic, administrative-territorial, legal and other spheres of state activity.

Vital sign monitoring using wearable devices in a Vietnamese intensive care unit

Medical education reforms are a crucial component to ensuring healthcare systems can meet current and future population needs. In 2010, a Lancet commission called for ‘a new century of transformative...

Intestinal Flora Disorder by Smoking Aggravation Inflammatory Reaction of Sepsis Through Regulation of the Mitochondrial Damage Through NLRP3 Inflammasome by FFAR2

Background: Sepsis is a common critical illness in ICU and always a great difficulty in clinical treatment, is associated with intestinal flora disorder. However, the biological contribution of chronic smoking on intestinal flora disorder of sepsis has not been previously investigated. We investigated the mechanisms by which intestinal flora disorder by smoking, a possible role for distinguish sepsis, contributes to the pathogenesis of sepsis-induced inflammatory reaction. Methods: We performed studies with mice were induced to sepsis by Cecal ligation and puncture (CLP), CLP mice were raised with intestinal flora disorder (OM, orally microbiome) by smoking. Lung tissues and cell samples were analyzed by histology, quantitative polymerase chain reaction, enzyme-linked immunosorbent assay and western blot. Findings: Smoking significantly brought about intestinal flora disorder in sepsis model. Intestinal flora disorder by smoking promoted the risk of sepsis-induced inflammatory reactions. Intestinal flora disorder by smoking reduced short chain fatty acid (SCFAs) to open ROS-dependently mitochondrial damage in macrophage of sepsis model via the activation of NLRP3 Inflammasome by FFAR2/STAT3/ EBP50/Nox1/p47phox signal channel. Interpretation: These findings identify smoking-induced intestinal flora disorder as a possible important pathogenic factors of sepsis and may shed lights on understanding how sepsis-induced inflammation reaction. Funding: This work was supported by National Natural Science Foundation of China (81173134); Focus on research and development planning projects of Anhui Science and Technology Department (1804h080242); Natural science research project of Anhui university (KJ2017A248); Talent Introduction Program of Yijishan Hospital of Wannan Medical College (YR202005), Science and Technology Innovation Team of Yijishan Hospital of Wannan Medical College (YPF2019016) and Key project research fund of Wannan Medical College (WK2020ZF03 and WK2020F23). Declaration of Interest: The authors declare no competing interests. Ethical Approval: All animal experiments were approved by the Animal Care and Use Committee of Yijishan Hospital of Wannan Medical College.

Deep Convolutional Neural Network for Computer-Aided Detection of Breast Cancer Using Histopathology Images

The innovation in medical imaging technologies leads to a frenetic pace of change in health care. In recent years various deep learning algorithms play a significant role in medical image classification and diagnosis. The deep convolutional neural network (DCNN) has obtained impressive results in many health-related applications. The fine-tuning parameters and weight initialization is the major task to adapt pre-trained convolution models. We explored transfer learning approaches using Alexnet, and VGG-16 analyzed with their behavior. Also, the DCNN framework had developed and compared with Alex net and VGG-16 transfer learning models. The DCNN attained more significant results compare to transfer learning models. The DCNN procures outstanding performance for binary (93.38%) and multi-class (average 89.29%), which exceeds the previous state of the art techniques in the literature.

Amino acid formulas in patients with food allergy

The article presents modern approaches to the use of balanced formulas for nutrition and diet correction in children with various forms of food allergies. The guidelines are based on all available up to date evidence on the efficacy, safety and utility of using such innovative medical technology as specialized amino acid formulas. This formula is the targeted medical intervention for food allergies and confirmed cow's milk protein allergy, and particularly for patients with reduced physical growth and development (growth rates included). The material is based on methodological guidelines on the amino acid formulas usage previously developed by specialist experts of the Union of pediatricians of Russia in 2020.

Main approaches to treatment of hypoxia in acute respiratory distress syndrome, bacterial and viral pneumonia (part I)

The paper summarizes data on modern approaches to the diagnosis, prevention and treatment of severe acute parenchymal respiratory failure of various origins, including ARDS due to bacterial viral pneumonia. The work is based on the data of modern well-organized studies, analysis of international clinical guidelines with a high degree of evidence, as well as the results of our own long-term experimental studies and clinical observations of the treatment of patients with ARDS of various origins, including viral pneumonia of 2009, 2016, 2020. Scientifically grounded algorithms for prevention, differential diagnosis and personalized therapy of severe acute respiratory failure using innovative medical technologies and a wide range of respiratory and adjuvant treatment methods have been formulated. The authors tried to adapt as much as possible the existing current recommendations for the daily clinical practice of anesthesiologists and resuscitators.