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The Centers for Medicare and Medicaid Services' coverage with evidence development (CED) policy allows the agency to provide coverage for an item or service through a National Coverage Determination (NCD), conditional upon an agreement to collect evidence designed to address specific questions or uncertainties. The goals of this policy are to expedite beneficiary access to new items and services and to generate additional evidence on the impact of these items or services for Medicare beneficiaries. However, these goals have not been fully realized because of several issues with the way the policy has been implemented, including (1) a lack of clear criteria for when CED will be applied, (2) examples of CED data collection activities placing unnecessary burdens on clinicians and the potential for undue inducement on beneficiaries, and (3) a lack of clarity around the process and timeline for reconsidering and ending CED requirements. Additionally, there are cases in which the application of CED has failed to improve access to services for certain Medicare beneficiaries because no data collection activity was implemented in response to the CED requirement or because the NCD only allows the technology to be provided and studied in certain centers of excellence. We describe a roadmap for addressing these issues, which includes, for example, developing a framework to guide the application of coverage constraints in NCDs with CED requirements. Once these issues are addressed, the Centers for Medicare and Medicaid Services could consider expanding the use of CED to technologies that are not subject to NCDs. • Coverage with evidence development (CED) has the potential to expedite access to promising items or services while providing the Centers for Medicare and Medicaid Services (CMS) with a lever to generate additional evidence designed to address outstanding questions about the impact of these items and services on Medicare beneficiaries. • Medicare's CED policy has not fully achieved its goals because CMS has not clearly defined when it will apply CED requirements or its process and timeline for ending CED requirements. Additionally, there have been times when data collection activities implemented in response to CED have placed unnecessary burdens on providers, as well as times when CED has failed to improve access to technologies. • We provide a roadmap for addressing these issues, which describes steps CMS can take in partnership with other interested parties. These steps include, for example, adopting predictable criteria for when CED should be considered, such as when evidence suggests a technology is beneficial but there are significant outstanding questions about its value or risks. Once CMS addresses these issues, it could consider expanding the use of CED to technologies not subject to National Coverage Determinations. [ABSTRACT FROM AUTHOR]

Introduction: Innovative pricing and payment/reimbursement schemes have been proposed as one part of the solution to the problem of patient access to new health technologies or to the uncertainty about their long-term effectiveness. As part of a Horizon Europe research project on health innovation next generation pricing and payment models (HI-PRIX), this protocol illustrates the conceptual and methodological steps related to a scoping review aiming at investigating nature and scope of pricing and payment/reimbursement schemes applied to, or proposed for, existing or new health technologies. Methods: A scoping review of literature will be performed according to the PRISMA guidelines for scoping reviews (PRISMA-ScR) guidelines. The search will be conducted in three scientific databases (i.e., PubMed, Web of Science, and Scopus), over a 2010–2023 timeframe. The search strategy is structured around two blocks of keywords, namely "pricing and payment/reimbursement schemes," and "innovativeness" (of the scheme type or scheme use). A simplified search will be replicated in the gray literature. Studies illustrating pricing and payment/reimbursement schemes with a sufficient level of details to explain their characteristics and functioning will be deemed eligible to be considered for data synthesis. Pricing and payment/reimbursement schemes will be classified according to several criteria, such as their purpose, nature, governance, data collection needs, and foreseen distribution of risk. The results will populate a publicly available online tool, the Pay-for-Innovation Observatory. Discussion: The findings of this review have the potential to offer a comprehensive toolkit with a variety of pricing and payment schemes to policymakers and manufacturers facing reimbursement and access decisions. [ABSTRACT FROM AUTHOR]

Traditional rondavel building patterns, designs and materials have changed due to urbanisation, economic status, globalisation, and modernisation. There is limited understanding of how the architectural change has impacted the utilisation of rondavel space. This study uses the concept of habitus to understand whether the changing design of traditional rondavels has influenced their utilisation, based on a case study of the Mbhashe Local Municipality in the Eastern Cape province, South Africa. The data was collected using semi-structured interviews. The findings reveal the habitus of the AmaXhosa people on how they utilise traditional rondavels (family house) for childbirth, placing a deceased's coffin, sleeping, seating, food preparation, serving and storage, keeping the spear, hosting ceremonies, communicating with ancestors, and interacting with the living. While the influence of contemporary architecture has changed the construction of rondavels, the inhabitants have not resisted changes to the architecture or cultural values as they have found different ways to adapt. Certain old dispositions are adaptable to contemporary structures, but some people are uninterested in adapting elements to the contemporary rondavel. Some habits of utilising traditional rondavels cannot be adapted to the contemporary rondavel because of health and medical innovations. [ABSTRACT FROM AUTHOR]

AbstractRecent decades have witnessed substantial interest in extracellular vesicles (EVs) due to their crucial role in intercellular communication across various biological processes. Among these, plant-derived exosome-like Nanoparticles (ELNs) have rapidly gained recognition as highly promising candidates. ELNs, characterized by diverse sources, cost-effective production, and straightforward isolation, present a viable option for preventing and treating numerous diseases. Furthermore, ELNs hold significant potential as carriers for natural or engineered drugs, enhancing their attractiveness and drawing considerable attention in science and medicine. However, translating ELNs into clinical applications poses several challenges. This study explores these challenges and offers critical insights into potential research directions. Additionally, it provides a forward-looking analysis of the industrial prospects for ELNs. With their broad applications and remarkable potential, ELNs stand at the forefront of biomedical innovation, poised to revolutionize disease management and drug delivery paradigms in the coming years. [ABSTRACT FROM AUTHOR]

Importance: The US leads the world in bringing new medical products to market, but the ability to generate evidence to inform clinical practice in postmarket settings needs improvement. Although a diverse group of stakeholders is working to improve postmarket evidence generation, the role of private payers has been underappreciated. Observations: Payers are crucial allies in improving evidence generation because better data would better inform coverage decisions, their policies and practices influence the conduct of care and research, and their claims data are a source of real-world evidence used in medical product evaluation. In addition, payers have a stake in improving evidence generation because the kinds of evidence needed to inform health care and coverage decisions are often not available when a product enters the market and may not be generated without their involvement. Here, we describe several key steps payers could take to improve evidence generation, including participating in efforts to reduce administrative and financial barriers to the conduct of clinical trials, directly incentivizing evidence generation on high-priority questions by funding potential cost-saving trials, increasing engagement with the medical products industry on evidentiary needs for coverage decisions, and improving usability of claims data by reducing data lags and routinely recording unique device identifiers. Broad payer engagement with US Food and Drug Administration recommendations regarding evidence generation will ensure that the opportunities to participate in clinical research are extended to all communities and that evidence needed to inform care is generated in trials and surveillance systems that reflect the clinical reality across the US. Conclusions and Relevance: Increasing payer involvement in evidence generation can benefit all participants in the medical innovation ecosystem. The importance of payers in these efforts will continue to grow in response to imperatives to increase integration of care and research, engage a diverse set of communities in clinical research, and move toward alternative payment models. This Special Communication discusses the current clinical trials system, examines why payers should support evidence generation, and suggests potential avenues for collaboration. [ABSTRACT FROM AUTHOR]

As a significant technological innovation in the fields of medicine and geriatric care, smart care wheelchairs offer a novel approach to providing high-quality care services and improving the quality of care. The aim of this review article is to examine the development, applications and prospects of smart nursing wheelchairs, with particular emphasis on their assistive nursing functions, multiple-sensor fusion technology, and human–machine interaction interfaces. First, we describe the assistive functions of nursing wheelchairs, including position changing, transferring, bathing, and toileting, which significantly reduce the workload of nursing staff and improve the quality of care. Second, we summarized the existing multiple-sensor fusion technology for smart nursing wheelchairs, including LiDAR, RGB-D, ultrasonic sensors, etc. These technologies give wheelchairs autonomy and safety, better meeting patients' needs. We also discussed the human–machine interaction interfaces of intelligent care wheelchairs, such as voice recognition, touch screens, and remote controls. These interfaces allow users to operate and control the wheelchair more easily, improving usability and maneuverability. Finally, we emphasized the importance of multifunctional-integrated care wheelchairs that integrate assistive care, navigation, and human–machine interaction functions into a comprehensive care solution for users. We are looking forward to the future and assume that smart nursing wheelchairs will play an increasingly important role in medicine and geriatric care. By integrating advanced technologies such as enhanced artificial intelligence, intelligent sensors, and remote monitoring, we expect to further improve patients' quality of care and quality of life. [ABSTRACT FROM AUTHOR]

The 4th China-Pakistan Medical Conference took place in Shanghai from June 28 to 30, 2024, and was considered a success. The conference brought together medical professionals from both countries to exchange knowledge and best practices in healthcare. The conference included discussions, presentations, and workshops covering various medical topics, providing an opportunity for professionals to learn from each other and enhance their skills. The event emphasized the importance of international cooperation in advancing healthcare initiatives and fostering strong professional relationships between China and Pakistan. The conference was seen as a significant milestone in promoting goodwill and cooperation between the medical communities of both countries. [Extracted from the article]

Background: Diffuse large B-cell lymphoma (DLBCL) is the predominant type of malignant B-cell lymphoma. Although various treatments have been developed, the limited efficacy calls for more and further exploration of its characteristics. Methods: Datasets from the Gene Expression Omnibus (GEO) database were used for identifying the tumor purity of DLBCL. Survival analysis was employed for analyzing the prognosis of DLBCL patients. Immunohistochemistry was conducted to detect the important factors that influenced the prognosis. Drug-sensitive prediction was performed to evaluate the value of the model. Results: VCAN, CD3G, and C1QB were identified as three key genes that impacted the outcome of DLBCL patients both in GEO datasets and samples from our center. Among them, VCAN and CD3G+ T cells were correlated with favorable prognosis, and C1QB was correlated with worse prognosis. The ratio of CD68 + macrophages and CD8 + T cells was associated with better prognosis. In addition, CD3G+T cells ratio was significantly correlated with CD68 + macrophages, CD4 + T cells, and CD8 +T cells ratio, indicating it could play an important role in the anti-tumor immunity in DLBCL. The riskScore model constructed based on the RNASeq data of VCAN, C1QB, and CD3G work well in predicting the prognosis and drug sensitivity. Conclusions: VCAN, CD3G, and C1QB were three key genes that influenced the tumor purity of DLBCL, and could also exert certain impact on drug sensitivity and prognosis of DLBCL patients. Funding: This work is supported by the Shenzhen High-level Hospital Construction Fund and CAMS Innovation Fund for Medical Sciences (CIFMS) (2022-I2M-C&T-B-062). [ABSTRACT FROM AUTHOR]

Artificial intelligence (AI) has the potential to transform every facet of cardiovascular practice and research. The exponential rise in technology powered by AI is defining new frontiers in cardiovascular care, with innovations that span novel diagnostic modalities, new digital native biomarkers of disease, and high-performing tools evaluating care quality and prognosticating clinical outcomes. These digital innovations promise expanded access to cardiovascular screening and monitoring, especially among those without access to high-quality, specialized care historically. Moreover, AI is propelling biological and clinical discoveries that will make future cardiovascular care more personalized, precise, and effective. The review brings together these diverse AI innovations, highlighting developments in multimodal cardiovascular AI across clinical practice and biomedical discovery, and envisioning this new future backed by contemporary science and emerging discoveries. Finally, we define the critical path and the safeguards essential to realizing this AI-enabled future that helps achieve optimal cardiovascular health and outcomes for all. [Display omitted] • AI-enabled technologies are increasingly integrated into cardiovascular practice and investigation. • Over the next decade, we envision an AI-propelled future in which the cardiovascular diagnostic and therapeutic landscape will effectively leverage multimodal data at the point of care. • Innovations in biomedical discovery and cardiovascular research are also set to make the future of cardiovascular care more personalized, precise, and effective. • The path to this future requires equitable and regulated adoption that prioritizes fairness, equity, safety, and partnerships with innovators as well as our communities and society. [ABSTRACT FROM AUTHOR]

Copyright of Revista Latinoamericana de Hipertension is the property of Revista Latinoamericana de Hipertension and its content may not be copied or emailed to multiple sites or posted to a listserv without the copyright holder's express written permission. However, users may print, download, or email articles for individual use. This abstract may be abridged. No warranty is given about the accuracy of the copy. Users should refer to the original published version of the material for the full abstract. (Copyright applies to all Abstracts.)

The integrative use of light and nanoassemblies has made a profound impact in the biomedical field for diagnosis, drug delivery, and phototherapy. Recent advances in the development of light‐responsive nanoassemblies showcase their capabilities in facilitating targeted diagnosis and therapy with minimal invasiveness, shaping the future of personalized medicine. In this work, the fundamental differences between types of light in biomedical applications, and the application of light‐responsive nanoassemblies in diagnosis and therapy are described, their biosafety profile is overviewed and discussed, and the translational challenges and potential clinical outlook of this emerging field are outlined. [ABSTRACT FROM AUTHOR]

Of all the numerous nanosized extracellular vesicles released by a cell, the endosomal-originated exosomes are increasingly recognized as potential therapeutics, owing to their inherent stability, low immunogenicity, and targeted delivery capabilities. This review critically evaluates the transformative potential of exosome-based modalities across pharmaceutical and precision medicine landscapes. Because of their precise targeted biomolecular cargo delivery, exosomes are posited as ideal candidates in drug delivery, enhancing regenerative medicine strategies, and advancing diagnostic technologies. Despite the significant market growth projections of exosome therapy, its utilization is encumbered by substantial scientific and regulatory challenges. These include the lack of universally accepted protocols for exosome isolation and the complexities associated with navigating the regulatory environment, particularly the guidelines set forth by the U.S. Food and Drug Administration (FDA). This review presents a comprehensive overview of current research trajectories aimed at addressing these impediments and discusses prospective advancements that could substantiate the clinical translation of exosomal therapies. By providing a comprehensive analysis of both the capabilities and hurdles inherent to exosome therapeutic applications, this article aims to inform and direct future research paradigms, thereby fostering the integration of exosomal systems into mainstream clinical practice. [ABSTRACT FROM AUTHOR]

Technological innovation in the medical area is vital when the COVID-19 pandemic strikes, including in Indonesia. One of the essential innovations is a health facility for infection testing. Through the TFRIC-19 program, several Indonesian researchers have developed a mobile laboratory named Mobile Lab Biosafety Level 2 (MBSL2). MBSL2 is one of the medical innovations from the TFRIC-19 program as a measure to handle the COVID-19 pandemic in Indonesia. TFRIC-19 is an innovation system initiated by government institutions in the RnD area. Establishing TFRIC-19 was the initial step in handling the COVID-19 pandemic in Indonesia. This research aims to identify the actor's role in developing MBSL2. The technique uses the Ecosystem Pie Model (EPM) approach for analysis. It was found that the most essential aspect of creating innovation is collaboration between involved actors. [ABSTRACT FROM AUTHOR]

Each year, an estimated 7·7 million deaths are attributed to bacterial infections, of which 4.95 million are associated with drug-resistant pathogens, and 1·27 million are caused by bacterial pathogens resistant to the antibiotics available. Access to effective antibiotics when indicated prolongs life, reduces disability, reduces health-care expenses, and enables access to other life-saving medical innovations. Antimicrobial resistance undoes these benefits and is a major barrier to attainment of the Sustainable Development Goals, including targets for newborn survival, progress on healthy ageing, and alleviation of poverty. Adverse consequences from antimicrobial resistance are seen across the human life course in both health-care-associated and community-associated infections, as well as in animals and the food chain. The small set of effective antibiotics has narrowed, especially in resource-poor settings, and people who are very young, very old, and severely ill are particularly susceptible to resistant infections. This paper, the first in a Series on the challenge of antimicrobial resistance, considers the global scope of the problem and how it should be measured. Robust and actionable data are needed to drive changes and inform effective interventions to contain resistance. Surveillance must cover all geographical regions, minimise biases towards hospital-derived data, and include non-human niches. [ABSTRACT FROM AUTHOR]

Copyright of Environmental & Social Management Journal / Revista de Gestão Social e Ambiental is the property of Environmental & Social Management Journal and its content may not be copied or emailed to multiple sites or posted to a listserv without the copyright holder's express written permission. However, users may print, download, or email articles for individual use. This abstract may be abridged. No warranty is given about the accuracy of the copy. Users should refer to the original published version of the material for the full abstract. (Copyright applies to all Abstracts.)

This study provides an in-depth review of bentonite, focusing on its applications in Korea's biomedical and cosmetic sectors. It delves into bentonite's chemical properties, which make it a valuable resource in various industries, particularly in the health and beauty industries. We discuss bentonite's antimicrobial properties, showcasing its effectiveness against a wide range of pathogens and its potential as a biomedicine adjuvant to boost immune responses. Despite its benefits, the review also addresses the need for caution due to its possible side effects when used in human therapy. In the cosmetics industry, bentonite is prized for its ability to absorb impurities, making it a popular ingredient in products from leading brands. The review highlights the ongoing research and development efforts aiming to further explore bentonite's capabilities and applications, underlining the material's significant contribution to advancing Korea's innovation in the biomedical and cosmetic fields. This review suggests that with more research, bentonite's full potential can be unlocked, offering new opportunities for these industries. [ABSTRACT FROM AUTHOR]

Medical affairs professionals are pivotal players at the intersection of medical innovation and practice in the pharmaceutical industry. They are uniquely positioned to translate complex medical knowledge into actionable insights for internal and external stakeholders. Industry-led continuing medical education (CME) programs, guided by these professionals, hold the potential to markedly improve clinicians' application of evidence-based medicine (EBM) in clinical settings, thereby elevating patient care outcomes. However, current CME techniques often overlook the integration of diverse disciplines such as educational theories, cognitive psychology, information mastery, and implementation science, which are important for effective real-time decision-making in patient care. This gap in integrating implementation science is vital, as it is key in ensuring that medical innovations are not just developed but also effectively implemented and efficiently utilized in clinical settings. In this opinion article, we aim to highlight the crucial yet often underrecognized role of medical affairs professionals in shaping robust and practical CME programs within the industry. We explore emerging trends and approaches in medical education and CME based on the principles of adult education. Additionally, we explore how medical affairs professionals can effectively drive the adoption of EBM in clinical practice. This exploration aims to provide insights into enhancing CME programs, with medical affairs professionals at the forefront of innovation and leadership in bridging gaps in clinical practice. [ABSTRACT FROM AUTHOR]

This essay challenges the idea of progress as technological development in relation to medicine by focusing on people rather than things. It analyzes how the prevalence of such an idea of progress leads contemporary societies to a technofetishism that degrades community life and medical practice, contributing to the medicalization of social life. It is argued that the realization of technological potentialities depends on their forms of use, that the main motive of technological development is unlimited profit, and the priority developments are those that enhance social control which maintains the status quo. Intelligence as an intelligence quotient is criticized by proposing it as an attribute of the human being as a whole, manifested in the ways of thinking and acting of human beings in their circumstances, where affectivity and critical thinking are essential for their development; it is emphasized that its antecedent is the harmonic concert of planetary life, which contrasts with the prevailing human disharmony. It is proposed that artificial intelligence is the latest creation of technofetishism, which deposits vital attributes in technology, and that its use will accentuate the degradation of human and planetary life. Another idea of medical progress is proposed, based on forms of organization that is conducive to the development of inquisitive, critical, and collaborative skills that promote permanent improvement, whose distant horizon is dignified progress: the spiritual, intellectual, moral, and convivial sublimation of collectivities in harmony with the planetary ecosystem. [ABSTRACT FROM AUTHOR]

Throughout history, progress in medicine has been intrinsically linked to the dynamics of warfare, driving innovations and transforming medical practices for the civilian population. This paper examines how World War I, characterized by the unprecedentedly large-scale utilization of trench warfare and modern mechanized weapons, catalyzed the development of medical technologies and techniques, fundamentally transforming medical practices thereafter. Key areas of medical progress discussed in this paper include facial reconstruction, vaccination for infectious diseases, mobile medical imaging, and blood preservation and transfusion, as well as their immediate and far-reaching impacts on society thereafter. Drawing upon a broad range of historical evidence such as first-hand account books, oral accounts, museum resources, and primary documents in French and English, this paper not only provides a comprehensive review of the major innovations in medical technology during World War I but also reveals the diverse personal perspectives that soldiers developed in response to the implementation of novel medical technology in that time, revealing the complex challenges associated with rapid medical and technological advancements. Overall, this paper explores the revolutionary impacts of important medical development during World War I and offers new insights into the interplay between wartime devastation and medical progress. [ABSTRACT FROM AUTHOR]

Copyright of Sozialer Fortschritt is the property of Duncker & Humblot GmbH and its content may not be copied or emailed to multiple sites or posted to a listserv without the copyright holder's express written permission. However, users may print, download, or email articles for individual use. This abstract may be abridged. No warranty is given about the accuracy of the copy. Users should refer to the original published version of the material for the full abstract. (Copyright applies to all Abstracts.)

Medicine is a continuously advancing science, characterized by the integration of multiple disciplines, ultimately focusing on the "human" aspect. Over the past half-century, there has been a global surge in efforts to reshape the humanistic spirit of medicine. Narrative medicine, a field that highly integrates medical professionalism with universal humanistic values, has developed rapidly in China from scratch over the past decade or so. This article introduces the development of narrative medicine both domestically and internationally, explains how to correctly understand the connotation of China's narrative medicine system and the significance of practicing narrative medicine. It analyzes current challenges in clinical practice, education and teaching, scientific research, doctor-patient consensus, and social recognition. Furthermore, it proposes directions for effort, namely, in the context of "greater health" and "new medical science", narrative medicine is empowered to help construct a harmonious medical narrative ecosystem, promote high-quality development in pediatrics, contribute to the innovation in medical education and talent training with humanistic strength and wisdom. [ABSTRACT FROM AUTHOR]

Despite advances in diagnosis and treatment, breast cancer is still one of the three most common cancers in the world and a significant cause of morbidity and mortality. Lipids play a role in many basic physiological pathways in cells, from regulating cell homeostasis to energy expenditure. As in many types of cancer, changes in lipid metabolism and their relationship have been reported in breast cancer. The STARD3 gene encodes a member of the subfamily of lipid trafficking proteins. It is a sterol-binding protein that mediates the transport of cholesterol from the endoplasmic reticulum to endosomes. It has been shown that STARD3 is correlated with human epidermal growth factor receptor 2 (HER2) amplification since it has the same localization as HER2 in the chromosome. In this review, we aimed to emphasize that investigating lipid metabolism together with the STARD3 biomarker has great potential not only for subtype-specific strategies but also for patient-specific strategies. [ABSTRACT FROM AUTHOR]

Artificial intelligence (AI) is rapidly transforming the field of medicine, announcing a new era of innovation and efficiency. Among AI programs designed for general use, ChatGPT holds a prominent position, using an innovative language model developed by OpenAI. Thanks to the use of deep learning techniques, ChatGPT stands out as an exceptionally viable tool, renowned for generating human-like responses to queries. Various medical specialties, including rheumatology, oncology, psychiatry, internal medicine, and ophthalmology, have been explored for ChatGPT integration, with pilot studies and trials revealing each field's potential benefits and challenges. However, the field of genetics and genetic counseling, as well as that of rare disorders, represents an area suitable for exploration, with its complex datasets and the need for personalized patient care. In this review, we synthesize the wide range of potential applications for ChatGPT in the medical field, highlighting its benefits and limitations. We pay special attention to rare and genetic disorders, aiming to shed light on the future roles of AI-driven chatbots in healthcare. Our goal is to pave the way for a healthcare system that is more knowledgeable, efficient, and centered around patient needs. [ABSTRACT FROM AUTHOR]

Research performed in Europe has driven cardiovascular device innovation. This includes, but is not limited to, percutaneous coronary intervention, cardiac imaging, transcatheter heart valve implantation, and device therapy of cardiac arrhythmias and heart failure. An important part of future medical progress involves the evolution of medical technology and the ongoing development of artificial intelligence and machine learning. There is a need to foster an environment conducive to medical technology development and validation so that Europe can continue to play a major role in device innovation while providing high standards of safety. This paper summarizes viewpoints on the topic of device innovation in cardiovascular medicine at the European Society of Cardiology Cardiovascular Round Table, a strategic forum for high-level dialogue to discuss issues related to the future of cardiovascular health in Europe. Devices are developed and improved through an iterative process throughout their lifecycle. Early feasibility studies demonstrate proof of concept and help to optimize the design of a device. If successful, this should ideally be followed by randomized clinical trials comparing novel devices vs. accepted standards of care when available and the collection of post-market real-world evidence through registries. Unfortunately, standardized procedures for feasibility studies across various device categories have not yet been implemented in Europe. Cardiovascular imaging can be used to diagnose and characterize patients for interventions to improve procedural results and to monitor devices long term after implantation. Randomized clinical trials often use cardiac imaging-based inclusion criteria, while less frequently trials randomize patients to compare the diagnostic or prognostic value of different modalities. Applications using machine learning are increasingly important, but specific regulatory standards and pathways remain in development in both Europe and the USA. Standards are also needed for smart devices and digital technologies that support device-driven biomonitoring. Changes in device regulation introduced by the European Union aim to improve clinical evidence, transparency, and safety, but they may impact the speed of innovation, access, and availability. Device development programmes including dialogue on unmet needs and advice on study designs must be driven by a community of physicians, trialists, patients, regulators, payers, and industry to ensure that patients have access to innovative care. [ABSTRACT FROM AUTHOR]

Background: Advancements in the medical field have made organ transplantation an attractive treatment option for patients when indicated. Shortage of organs and commodification of organs are major challenges encountered in organ donation and transplantation. These could potentially breed unethical practices, if the process is not well regulated. Aim: The aim of this study was to assess the knowledge of healthcare workers (HCWs) on the legal provisions regulating organ donation and transplantation in Nigeria. Methodology: This cross-sectional study was conducted amongst physicians and nurses across Nigeria. Knowledge of legal provisions on organ donation and transplantation was assessed using a validated questionnaire that had 21 questions derived from the National Health Act. Each correctly answered question was given 1 point with a total obtainable score of 21 points. A score of ≥14 points was classified as good knowledge. P <0.05 was considered significant. Results: A total of 836 physicians and nurses with a mean age of 37.61 ± 9.78 years participated in the study. Females and physicians constituted 53.3% and 62.9% of the respondents, respectively. The mean knowledge score of the respondents was 9.70 ± 2.91 points. Eighty-three (9.9%) respondents had a good knowledge score. There was a significantly higher proportion of male HCWs (P < 0.037) and older HCWs (P = 0.017) with good knowledge of legal provisions. On logistic regression, age was the only factor found to be associated with good knowledge of legal provision (adjusted odds ratio: 3.92; confidence interval: 1.33-11.59; P = 0.01). Conclusion: The overall knowledge of legal provisions on organ donation and transplant was very poor amongst HCWs in Nigeria. There is a need to educate them on these provisions to curb unethical practices. [ABSTRACT FROM AUTHOR]

Medical imaging techniques play a crucial role in diagnosing major diseases such as cardiovascular diseases, cancers, and neurological disorders. The BMC Methods Collection "Advances in medical imaging techniques" will showcase the latest advancements in this field, including state-of-the-art imaging modalities, novel biomedical applications, progress in molecular probes and radiopharmaceuticals, and innovative methodologies for image analysis, data fusion, and visualization. [ABSTRACT FROM AUTHOR]

The Medical Subject Headings (MeSH) thesaurus is a controlled vocabulary developed by the U.S. National Library of Medicine (NLM) for classifying journal articles. It is increasingly used by researchers studying medical innovation to classify text into disease areas and other categories. Although this process was once manual, human indexers are now assisted by algorithms that automate some of the indexing process. NLM has made one of their algorithms, the Medical Text Indexer (MTI), available to researchers. MTI can be used to easily assign MeSH descriptors to arbitrary text, including from document types other than publications. However, the reliability of extending MTI to other document types has not been studied directly. To assess this, we collected text from grants, patents, and drug indications, and compared MTI's classification to expert manual classification of the same documents. We examined MTI's recall (how often correct terms were identified) and found that MTI identified 78% of expert-classified MeSH descriptors for grants, 78% for patents, and 86% for drug indications. This high recall could be driven merely by excess suggestions (at an extreme, all diseases being assigned to a piece of text); therefore, we also examined precision (how often identified terms were correct) and found that most MTI outputs were also identified by expert manual classification: precision was 53% for grant text, 73% for patent text, and 64% for drug indications. Additionally, we found that recall and precision could be improved by (i) utilizing ranking scores provided by MTI, (ii) excluding long documents, and (iii) aggregating to higher MeSH categories. For simply detecting the presence of any disease, MTI showed > 94% recall and > 87% precision. Our overall assessment is that MTI is a potentially useful tool for researchers wishing to classify texts from a variety of sources into disease areas. [ABSTRACT FROM AUTHOR]

Existing medical literature is dominated by descriptions of Africa as a mere consumer of Euro-West medical practices without acknowledging Africa's role in medical innovation and practices. This article closes this gap, which has practical implications. The article aims to highlight the rise of medical practices in Africa from ancient times to the present. The article utilises a historical analysis of the literature available in both grey and academic literature. The sources used include books, reports, and biographies and were identified using terms such as African agency, African medicine, ancient technologies in Africa, and diseases in Africa as key terms. The articles were selected from the Web of Science and Google Scholar databases for standardisation purposes. The article shows that before the Europeans invaded Africa, more advanced medicine and medical practices such as disease treatment, immunisation through inoculation, and quarantine of the people infected or exposed to particular diseases already existed on the continent, while immunisation was only known in Europe after 1721. Africans used a variety of plants with salicylic acid for pain, kaolin for diarrhoea, and also extracts that Euro-West researchers discovered only in the 20th century to kill Gramme-positive bacteria. The article concludes that Africans have, therefore, never played a passive but rather a leading role in the fields of innovation and medicine. [ABSTRACT FROM AUTHOR]

Despite the current promise of immunotherapy, many cancer patients still suffer from challenges such as poor immune response rates, resulting in unsatisfactory clinical efficacy of existing therapies. There is an urgent need to combine emerging biomedical discoveries and innovations in traditional therapies. Modulation of the cGAS-STING signalling pathway represents an important innate immunotherapy pathway that serves as a crucial DNA sensing mechanism in innate immunity and viral defense. It has attracted increasing attention as an emerging target for cancer therapy. The recent advancements in nanotechnology have led to the significant utilization of nanomaterials in cancer immunotherapy, owing to their exceptional physicochemical properties such as large specific surface area and efficient permeability. Given the rapid development of cancer immunotherapy driven by the cGAS-STING activation, this study reviews the latest research progress in employing nanomaterials to modulate this signaling pathway. Based on the introduction of the main activation mechanisms of cGAS-STING pathway, this review focuses on nanomaterials that mediate the agonists involved and effectively activate this signaling pathway. In addition, combination nanotherapeutics based on the activation of the cGAS-STING signaling pathway are also discussed, including emerging strategies combining nanoformulated agonists with chemotherapy, radiotherapy as well as other immunomodulation in tumor targeting therapy. Given the rapid development of cancer immunotherapy driven by the cGAS / STING activation, this study reviews the latest research advances in the use of nanomaterials to modulate this signaling pathway. Based on the introduction of key cGAS-STING components and their activation mechanisms, this review focuses on nanomaterials that can mediate the corresponding agonists and effectively activate this signaling pathway. In addition, combination nanotherapies based on the activation of the cGAS-STING signaling pathway are also discussed, including emerging strategies combining nanoformulated agonists with chemotherapy, radiotherapy as well as immunomodulation in cancer therapy,. [Display omitted] [ABSTRACT FROM AUTHOR]

In an era of accelerating biomedical innovations, partial ectogenesis looms as a double-edged sword for female bodily autonomy and reproductive rights. Rather than simplifying or 'solving' abortion access and the ethical issues inherent to that right, this technology wields the alarming potential to curtail women's right to safe and legal abortions. This article investigates the potential of partial ectogenesis as a 'solution' to the abortion debate, focusing on two significant hypotheses. Foremost, the paper scrutinizes the dilemma of ectogenesis abortion; specifically, instances where a woman intending to terminate her pregnancy is obliged to undergo foetal transfer surgery. This scrutiny engages with Räsänen's concept of the right to the death of a foetus, yet ultimately concludes that this supposed right is unconvincing. Despite there being no such right, this paper argues that the prospect of partial ectogenesis is incapable of resolving the core issues of the abortion debate, not least because of the inherent conflict between a woman's right to her own body and the proposed technology or rather, compulsion of such surgeries. Instead, this article posits that a more significant ethical and logical concern lies in misconceptions surrounding the term 'foetus' and how such misconceptions impact considerations of autonomy. Thereafter, this paper examines the potential for partial ectogenesis to alter the legal viability threshold set by the Abortion Act 1967-in particular, this paper explores the impact a shift in the viability threshold would have on female bodily autonomy. In the aim of resolving these concerns, this article concludes by advocating for the decriminalisation of abortion to safeguard female bodily autonomy against constraints on abortion access were the viability threshold legally revised. By addressing these crucial topics, this article aims to provide a nuanced analysis of the dialogue surrounding reproductive rights, bodily autonomy, and the complex interplay between emerging biotechnologies, medical ethics and legislative frameworks. [ABSTRACT FROM AUTHOR]

Integrating modern and innovative technologies such as the Internet of Things (IoT) and Machine Learning (ML) presents new opportunities in healthcare, especially in medical spa therapies. Once considered palliative, these therapies conducted using mineral/thermal water are now recognized as a targeted and specific therapeutic modality. The peculiarity of these treatments lies in their simplicity of administration, which allows for prolonged treatments, often lasting weeks, with progressive and controlled therapeutic effects. Thanks to new technologies, it will be possible to continuously monitor the patient, both on-site and remotely, increasing the effectiveness of the treatment. In this context, wearable devices, such as smartwatches, facilitate non-invasive monitoring of vital signs by collecting precise data on several key parameters, such as heart rate or blood oxygenation level, and providing a perspective of detailed treatment progress. The constant acquisition of data thanks to the IoT, combined with the advanced analytics of ML technologies, allows for data collection and precise analysis, allowing real-time monitoring and personalized treatment adaptation. This article introduces an IoT-based framework integrated with ML techniques to monitor spa treatments, providing tailored customer management and more effective results. A preliminary experimentation phase was designed and implemented to evaluate the system's performance through evaluation questionnaires. Encouraging preliminary results have shown that the innovative approach can enhance and highlight the therapeutic value of spa therapies and their significant contribution to personalized healthcare. [ABSTRACT FROM AUTHOR]

The development of innovations aimed at tackling grand challenges requires the support of an appropriate innovation ecosystem. However, there is a limited understanding of how such innovation ecosystems emerge in contexts of absolute uncertainty. We addressed this gap by examining the boundary work carried out by key actors in the creation of the biomedical innovation ecosystem in India that supported the development of a successful low‐cost heart valve over the 1976–1995 period. We developed a process model demonstrating how the ecosystem leader co‐created the innovation ecosystem that led to the development of a low‐cost heart valve by engaging in three types of configuration boundary work: establishing ecosystem configuration, modeling ecosystem configuration, and expanding ecosystem configuration. Our study contributes to the literature on innovations for grand challenges, innovation ecosystems, and boundary work. [ABSTRACT FROM AUTHOR]

Copyright of Journal of Ankara University Faculty of Medicine / Ankara Üniversitesi Tip Fakültesi Mecmuasi is the property of Galenos Yayinevi Tic. LTD. STI and its content may not be copied or emailed to multiple sites or posted to a listserv without the copyright holder's express written permission. However, users may print, download, or email articles for individual use. This abstract may be abridged. No warranty is given about the accuracy of the copy. Users should refer to the original published version of the material for the full abstract. (Copyright applies to all Abstracts.)

The regulation of mass is essential for the development and homeostasis of cells and multicellular organisms. However, cell mass is also tightly linked to cell mechanical properties, which depend on the time scales at which they are measured and change drastically at the cellular eigenfrequency. So far, it has not been possible to determine cell mass and eigenfrequency together. Here, we introduce microcantilevers oscillating in the Ångström range to monitor both fundamental physical properties of the cell. If the oscillation frequency is far below the cellular eigenfrequency, all cell compartments follow the cantilever motion, and the cell mass measurements are accurate. Yet, if the oscillating frequency approaches or lies above the cellular eigenfrequency, the mechanical response of the cell changes, and not all cellular components can follow the cantilever motions in phase. This energy loss caused by mechanical damping within the cell is described by the quality factor. We use these observations to examine living cells across externally applied mechanical frequency ranges and to measure their total mass, eigenfrequency, and quality factor. The three parameters open the door to better understand the mechanobiology of the cell and stimulate biotechnological and medical innovations. There is increasing interest in measuring the mechanical properties of living cells. Here, the authors develop a method to simultaneously measure the cell mass and two parameters related to its natural oscillation or resonance frequencies. [ABSTRACT FROM AUTHOR]

Background: mRNA technology is currently being investigated for a range of oncology indications. We assessed the willingness to pay (WTP) of the general population in Israel for a hypothetical novel mRNA-based treatment for oncology indications. Methods: We used a contingent valuation methodology to elicit WTP using a web-based questionnaire. A sample of adult participants were presented with a hypothetical scenario in which an mRNA-based intervention increased the likelihood of a cure for various cancer types from 20% to 40% (half of the sample), or 60% (the other half of the sample). Results: 531 respondents completed the questionnaire. The mean, median and mode WTP for the proposed hypothetical treatment in both scenarios were ILS65,000 (± ILS114,000), ILS20,000 and ILS50,000, respectively (1USD = 3.4ILS). The WTP was skewed towards zero, and 9.6% of the respondents were not willing to pay any amount. WTP higher amounts was significantly associated with higher income (p < 0.01), self-reported good health (p < 0.05), supplementary health insurance (p < 0.05), Jews compared to other populations (p < 0.01), interest in technology (p < 0.001) and a tendency to adopt medical innovations (p < 0.001). No statistical difference between the 40% vs. the 60% potential cure scenarios was found. Logistic and OLS regressions indicated that age, religion, income, and interest in adopting medical innovations were the best predictors of respondents' WTP. Conclusion: Despite the scientific breakthroughs in oncology treatment over the last few decades, many types of cancer are still incurable. Given the expected development of innovative mRNA-based treatments for cancer, these results should inform policymakers, the pharmaceutical industry and other stakeholders on the future coverage and reimbursement of these technologies incorporating patients' and societal views. To date, WTP considerations have not been given much weight in prioritization of drug reimbursement processes, neither in Israel nor in other countries. As a pioneer in adoption of the mRNA technology, Israel can also lead the incorporation of WTP considerations in this field. [ABSTRACT FROM AUTHOR]

Sub-health state is a state of health and low quality between disease and health. The theoretical basis of children's sub-health is to start from the whole. The common clinical sub-health conditions cannot be explained by modern detection methods, and it can be screened and analyzed with the help of big data in medical informatization. The combination of "Internet + " and the health care model is an innovation in the construction of medical informatization. It can provide many considerate services to the masses in time and alleviate the anxiety of illness. Therefore, it is very necessary to carry out the efficacy evaluation of children's sub-health from the perspective of medical information. Therefore, this paper completes the following work with the help of AI neural network: (1) This paper proposes an improved AlexNet network evaluation method based on attention mechanism. In this study, attention mechanism is added to the original AlexNet model to weight each channel of the feature layer. At the same time, we improve the large convolution kernel of the previous layers of the original AlexNet network and use batch normalization instead of the local response normalization (LRN) layer in the original model. (2) This paper proposes an evaluation method based on improved residual network, which improves the original residual block of the residual model and widens the residual block. The residual block can effectively reduce the amount of network parameters and improve the efficiency of network training. (3) This paper proposes an evaluation method of multi-scale feature fusion (MSFF). The features extracted from the improved AlexNet and residual network are fused and then evaluated. At this time, the training time is greatly shortened, and the accuracy is higher than that of single model. [ABSTRACT FROM AUTHOR]

This review article explores the dynamic field of radiopharmaceuticals, where innovative developments arise from combining radioisotopes and pharmaceuticals, opening up exciting therapeutic possibilities. The in-depth exploration covers targeted drug delivery, delving into passive targeting through enhanced permeability and retention, as well as active targeting using ligand-receptor strategies. The article also discusses stimulus-responsive release systems, which orchestrate controlled release, enhancing precision and therapeutic effectiveness. A significant focus is placed on the crucial role of radiopharmaceuticals in medical imaging and theranostics, highlighting their contribution to diagnostic accuracy and image-guided curative interventions. The review emphasizes safety considerations and strategies for mitigating side effects, providing valuable insights into addressing challenges and achieving precise drug delivery. Looking ahead, the article discusses nanoparticle formulations as cutting-edge innovations in next-generation radiopharmaceuticals, showcasing their potential applications. Real-world examples are presented through case studies, including the use of radiolabelled antibodies for solid tumors, peptide receptor radionuclide therapy for neuroendocrine tumors, and the intricate management of bone metastases. The concluding perspective envisions the future trajectory of radiopharmaceuticals, anticipating a harmonious integration of precision medicine and artificial intelligence. This vision foresees an era where therapeutic precision aligns seamlessly with scientific advancements, ushering in a new epoch marked by the fusion of therapeutic resonance and visionary progress. [ABSTRACT FROM AUTHOR]

We investigate the relationship across U.S. states between indicators of the growth in the quality of medical goods and services used by elderly Medicare enrollees and the growth or decline in their disability, during the period 2013-2019. Our indicators of quality are the utilization-weighted mean vintages of prescription drugs and of medical services and procedures. We control for person-level demographic characteristics (sex, age, race, education, marital status), state/year characteristics (Medicare spending per enrollee, per capita income, prevalence of chronic conditions), state fixed effects, and year fixed effects. Our estimates indicate that the numbers of 2019 beneficiaries with three types of disabilities—cognition, vision, and independent living difficulties—were each reduced by between 650 and 760 thousand by the 2013-2019 increase in drug vintage, and that the numbers of 2019 beneficiaries with self-care and ambulation difficulties were each reduced by about 1.1 million by the 2013-2019 increase in drug vintage. The 2013-2019 increase in drug vintage reduced the mean number of disabilities from 0.91 to 0.82—77% of the observed increase—and it reduced the total number of disabilities by 4.9 million. The incremental drug cost per reduced disability may have been $5555, which seems quite reasonable. [ABSTRACT FROM AUTHOR]

Quantum biology studies span multiple disciplines including physics, engineering, and biology with the goal of understanding the quantum underpinnings of living systems. Recent findings have brought wide attention to the role of quantum mechanisms in the function and regulation of biological processes. Moreover, a number of activities have been integral in building a vibrant quantum biology community. Due to the inherent interdisciplinary nature of the field, it is a challenge for quantum biology researchers to integrate and advance findings across the physical and biological disciplines. Here we outline achievable approaches to developing a shared platform—including the establishment of standardized manipulation tools and sensors, and a common scientific lexicon. Building a shared community framework is also crucial for fostering robust interdisciplinary collaborations, enhancing knowledge sharing, and diversifying participation in quantum biology. A unified approach promises not only to deepen our understanding of biological systems at a quantum level but also to accelerate the frontiers of medical and technological innovations. [ABSTRACT FROM AUTHOR]

During the past 20 years, significant advances have been made in better understanding of the complex problem of cerebral palsy (CP). The most significant contribution has been made by the introduction of our Kurjak antenatal neurodevelopmental test (KANET), which in many multicentric studies proved to be successful in separating healthy fetuses from those with CP and other neurological problems. In this review article, we tried to review present knowledge on CP. [ABSTRACT FROM AUTHOR]

Rapid improvements in the field of prenatal medicine have been achieved due to the technological advancement of ultrasonography that has allowed recognition of various ultrasonographic findings and their combination with biochemical results and demographic characteristics in order to estimate a final individual risk for a chromosomal anomaly of the fetus and analysis of short fragments of fetal DNA released into the mother's bloodstream through a natural process of cell death. Invasive testing still remains the main clinically available diagnostic modality for the definite diagnosis of both chromosomal anomalies and many single-gene disorders. Amniocentesis is performed between 15 and 20 weeks of pregnancy to obtain fetal cells for genetic testing. This method is performed almost in the middle of pregnancy, and waiting for the results of the analysis may indicate termination of pregnancy in the second trimester. Chorionic villus sampling (CVS), usually performed between 11+0 and 13+6 weeks of gestation, is one of the invasive diagnostic methods used to diagnose chromosomal, genetic, and metabolic diseases in the embryonic period. Invasive procedures such as CVS and amniocentesis still remain the only definitive diagnostic tests for aneuploidy in pregnancy. CVS, as an invasive procedure carried out with experienced physicians in specialist centers, is not associated with a significant increase in fetal loss rate, with a risk rate below 0.5%, and the possible background risk for miscarriage is significantly higher in the presence of fetal anomaly and abnormal karyotype. Ultrasound-guided transabdominal (TA) CVS is a useful outdoor procedure and is considered the method of choice for fetal sampling and accurate early prenatal diagnosis. [ABSTRACT FROM AUTHOR]

The presented article provides a systematic review of the pharmaceutical legislation (EU Pharmaceutical Package) - the current proposal of the European Commission for a new Directive, repealing and replacing Directives and modifying Regulations of the European Parliament and of the Council, incorporating the relevant parts of the Regulation concerning medicinal products for pediatrics, Regulation for orphan drugs and others, aiming at revision of the pharmaceutical legislation in the context of antimicrobial resistance and challenges facing the introduction of innovative antimicrobial medicines in Europe. It outlines a critical analysis on the impact of the changes in the context of introduction of innovative antimicrobial medicinal products with an emphasis on unsatisfied medical demands of the European population. The revision of the pharmaceutical legislation provides an argument to consider that the proposed Pharmaceutical Package could resolve some of the issues associated with the access to novel antibiotic medicines. It is necessary to find a consensus and a balance between, on the one hand, meeting the need for antibiotics for the citizens of the European Union and, on the other hand, providing timely access to generic medicines to meet the needs of the population. [ABSTRACT FROM AUTHOR]

Copyright of Gümüshane Üniversitesi Saglik Bilimleri Dergisi is the property of Gumushane University, Faculty of Health Sciences and its content may not be copied or emailed to multiple sites or posted to a listserv without the copyright holder's express written permission. However, users may print, download, or email articles for individual use. This abstract may be abridged. No warranty is given about the accuracy of the copy. Users should refer to the original published version of the material for the full abstract. (Copyright applies to all Abstracts.)