Use of diabetes technology in children.

Children with type 1 diabetes and their caregivers face numerous challenges navigating the unpredictability of this complex disease. Although the burden of managing diabetes remains significant, new technology has eased some of the load and allowed children with type 1 diabetes to achieve tighter glycaemic management without fear of excess hypoglycaemia. Continuous glucose monitor use alone improves outcomes and is considered standard of care for paediatric type 1 diabetes management. Similarly, automated insulin delivery (AID) systems have proven to be safe and effective for children as young as 2 years of age. AID use improves not only blood glucose levels but also quality of life for children with type 1 diabetes and their caregivers and should be strongly considered for all youth with type 1 diabetes if available and affordable. Here, we review key data on the use of diabetes technology in the paediatric population and discuss management issues unique to children and adolescents.

Robot-Assisted Surgery and Racial and Ethnic Disparities in Post-Prostatectomy Outcomes Among Prostate Cancer Patients.

BACKGROUND: We sought to determine whether the differences in short-term outcomes between patients undergoing robot-assisted radical prostatectomy (RARP) and those treated with open radical prostatectomy (ORP) differ by race and ethnicity. METHODS: This observational study used New York State Cancer Registry data linked to discharge records and included patients undergoing radical prostatectomy for localized prostate cancer during 2008-2018. We used logistic regression to examine the association between race and ethnicity (non-Hispanic White [NHW], non-Hispanic Black [NHB], Hispanic), surgical approach (RARP, ORP), and postoperative outcomes (major events, prolonged length of stay [pLOS], 30-day re-admission). We tested interaction between race and ethnicity and surgical approach on multiplicative and additive scales. RESULTS: The analytical cohort included 18,926 patients (NHW 14,215 [75.1%], NHB 3195 [16.9%], Hispanic 1516 [8.0%]). The average age was 60.4 years (standard deviation 7.1). NHB and Hispanic patients had lower utilization of RARP and higher risks of postoperative adverse events than NHW patients. NHW, NHB, and Hispanic patients all had reduced risks of adverse events when undergoing RARP versus ORP. The absolute reductions in the risks of major events and pLOS following RARP versus ORP were larger among NHB {relative excess risk due to interaction (RERI): major events -0.32 [95% confidence interval (CI) -0.71 to -0.03]; pLOS -0.63 [95% CI -0.98 to -0.35]) and Hispanic (RERI major events -0.27 [95% CI -0.77 to 0.09]; pLOS -0.93 [95% CI -1.46 to -0.51]) patients than among NHW patients. The interaction was absent on the multiplicative scale. CONCLUSIONS: RARP use has not penetrated and benefited all racial and ethnic groups equally. Increasing utilization of RARP among NHB and Hispanic patients may help reduce disparities in patient outcomes after radical prostatectomy.

The heart of anaesthesiology: revitalising humanism in the age of technology.

Technological innovation has greatly aided modern medicine, and anaesthesiology in particular, but also contributes to dehumanising influences that promote physician burnout and dissatisfaction among patients. Here we advocate for a profound reaffirmation of humanistic principles-empathy, compassion, and communication-in perioperative medicine. We propose adaptable strategies to bolster humanism in practice, such as curricular offerings, simulation training, role modelling, and recognition. As perioperative technologies continue to evolve, the threat of depersonalisation in anaesthetic care looms, making commitments to humanism a crucial precondition for healing in the communities in which we work and live.

Robotic technology in surgery; a classification system of soft tissue surgical robotic devices.

BACKGROUND: The field of robotic-assisted surgery is rapidly growing as many robotic surgical devices are in development and about to enter the market. Currently, there is no universally accepted language for labeling the different robotic systems. To facilitate this communication, we created what is, to our knowledge, the first classification of surgical robotic technologies that organizes and classifies surgical robots used for endoscopy, laparoscopy and thoracoscopy. METHODS: We compiled a list of surgical robots intended to be used for endoscopy, laparoscopy, and/or thoracoscopy by searching United States, European, Hong Kong, Japan, and Korean databases for approved devices. Devices showcased at the 2023 Annual Meeting for the Society of Robotic Surgery were added. We also systematically reviewed the literature for any existing surgical robotic classifications or categorizations. We then created a multidisciplinary committee of 8 surgeons and 2 engineers to construct a proposed classification of the devices included in our search. RESULTS: We identified 40 robotic surgery systems intended to be used for endoscopy, laparoscopy and/or thoracoscopy. The proposed classification organizes robotic devices with regard to architecture, port design, and configuration (modular carts, multi-arm integrated cart, table-attachable or arm-table integration). CONCLUSION: This 3-level classification of robotic surgical devices used for endoscopy, laparoscopy and/or thoracoscopy describes important characteristics of robotic devices systematically.

Deep brain stimulation of the subthalamic nucleus in Parkinson disease 2013-2023: where are we a further 10 years on?

Deep brain stimulation has been in clinical use for 30 years and during that time it has changed markedly from a small-scale treatment employed by only a few highly specialized centers into a widespread keystone approach to the management of disorders such as Parkinson's disease. In the intervening decades, many of the broad principles of deep brain stimulation have remained unchanged, that of electrode insertion into stereotactically targeted brain nuclei, however the underlying technology and understanding around the approach have progressed markedly. Some of the most significant advances have taken place over the last decade with the advent of artificial intelligence, directional electrodes, stimulation/recording implantable pulse generators and the potential for remote programming among many other innovations. New therapeutic targets are being assessed for their potential benefits and a surge in the number of deep brain stimulation implantations has given birth to a flourishing scientific literature surrounding the pathophysiology of brain disorders such as Parkinson's disease. Here we outline the developments of the last decade and look to the future of deep brain stimulation to attempt to discern some of the most promising lines of inquiry in this fast-paced and rapidly evolving field.

Application of the Stanford Biodesign Framework in Healthcare Innovation Training and Commercialization of Market Appropriate Products: A Scoping Review.

The Stanford Biodesign needs-centric framework can guide healthcare innovators to successfully adopt the 'Identify, Invent and Implement' framework and develop new healthcare innovations products to address patients' needs. This scoping review explored the application of the Stanford Biodesign framework for healthcare innovation training and the development of novel healthcare innovative products. Seven electronic databases were searched from their respective inception dates till April 2023: PubMed, Embase, CINAHL, PsycINFO, Web of Science, Scopus, ProQuest Dissertations, and Theses Global. This review was reported according to the Preferred Reporting Items for Systematic Reviews and Meta-Analysis extension for Scoping Reviews and was guided by the Arksey and O'Malley's scoping review framework. Findings were analyzed using Braun and Clarke's thematic analysis framework. Three themes and eight subthemes were identified from the 26 included articles. The main themes are: (1) Making a mark on healthcare innovation, (2) Secrets behind success, and (3) The next steps. The Stanford Biodesign framework guided healthcare innovation teams to develop new medical products and achieve better patient health outcomes through the induction of training programs and the development of novel products. Training programs adopting the Stanford Biodesign approach were found to be successful in improving trainees' entrepreneurship, innovation, and leadership skills and should continue to be promoted. To aid innovators in commercializing their newly developed medical products, additional support such as securing funds for early start-up companies, involving clinicians and users in product testing and validation, and establishing new guidelines and protocols for the new healthcare products would be needed.

From Photography to Radiology: How Physicians Leveraged Early Hospital X-ray Machines to Supplant Photographers.

At the end of the nineteenth century, the advent of x-ray machines fueled American medicine's reliance on technology, transforming hospitals and the medical profession. X-ray manufacturers pursued the nascent hospital market as competition and patent feuds accelerated x-ray machine modifications. Hospitals incorporated clunky new machines and employed x-ray photographers, but as the unruly apparatus stabilized, physicians joining the new specialty of radiology discounted the toils of machine troubleshooting and promoted their medically qualified x-ray interpretations. This article frames early medical radiography in terms of boundary work, highlighting how discourse among physicians, x-ray photographers, and hospital administrators vied to establish a privileged demarcation between radiological science and photographic craft. Ultimately, radiologists supplanted x-ray photographers by leveraging the automation of x-ray machines and capitalizing on the epistemic shift from photographic objectivity to qualified interpretations. By focusing on this overlooked aspect of x-ray incorporation into hospitals, this work provides a unique perspective on how harnessing mechanization and authoritative medical interpretations can shift professional boundaries.

Denosumab treatment for progressive Enneking stage II cervical giant-cell tumor conservatively.

Cervical giant cell tumor of the bone (GCTB) is a rare, primary benign bone tumor in pediatric patients. Surgery remains the primary choice for treating resectable cervical GCTB. Additional adjuvant therapeutic options are available for patients with unresectable cervical GCTB, including the anti-RANKL monoclonal antibody, denosumab. We represented a case incidentally found in a 7-year-old female, who complained severe craniocervical pain, grade 2-3 dysphagia, dysphonia, hypesthesia, and extremity weakness. The patient showed an impressive clinical response to denosumab, both clinically and radiologically, without adverse events or recurrence. To date, this is the youngest patient ever reported to have a progressive Enneking stage II C3 GCTB treated with denosumab alone. Denosumab can be administered as a single and conservative therapy for pediatric patients with unresectable upper cervical GCTB, avoiding the risks and morbidity of surgical and radiative treatment.

An Office-Based, Point-of-Care Test Predicts Treatment Outcomes With Community-Based Pelvic Floor Physical Therapy in Patients With Chronic Constipation.

BACKGROUND & AIMS: Rectal evacuation disorders are common among constipated patients. We aimed to evaluate the accuracy of an investigational point-of-care test (rectal expulsion device [RED]) to predict outcomes with community-based pelvic floor physical therapy. METHODS: We enrolled patients meeting Rome IV criteria for functional constipation failing fiber/laxatives for more than 2 weeks. RED was inserted and self-inflated, and then time-to-expel was measured in a left lateral position. All patients underwent empiric community-based pelvic floor physical therapy in routine care with outcomes measured at 12 weeks. The primary end point was global clinical response (Patient Assessment of Constipation Symptoms score reduction, >0.75 vs baseline). Secondary end points included improvement in health-related quality-of-life (Patient Assessment of Constipation Quality of Life score reduction, >1.0) and complete spontaneous bowel movement frequency (Food and Drug Administration complete spontaneous bowel movement responder definition). RESULTS: Thirty-nine patients enrolled in a feasibility phase to develop the use-case protocol. Sixty patients enrolled in a blinded validation phase; 52 patients (mean, 46.9 y; 94.2% women) were included in the intention-to-treat analysis. In the left lateral position, RED predicted global clinical response (generalized area under the curve [gAUC], 0.67; 95% CI, 0.58-0.76]), health-related quality-of-life response (gAUC, 0.67; 95% CI, 0.58-0.77; P < .001), and complete spontaneous bowel movement response (gAUC, 0.63; 95% CI, 0.57-0.71; P < .001). As a screening test, a normal RED effectively rules out evacuation disorders (expected clinical response, 8.9%; P = .042). Abnormal RED in the left lateral position (defined as expulsion within 5 seconds or >120 seconds) predicted 48.9% clinical response to physical therapy. A seated maneuver enhanced the likelihood of clinical response (71.1% response with seated RED retained >13 seconds) but likely is unnecessary in most settings. CONCLUSIONS: RED offers an opportunity to disrupt the paradigm by offering a personalized approach to managing chronic constipation in the community (Clinicaltrials.gov: NCT04159350).

Long-term non-invasive ventilation in children: Transition from hospital to home.

Long-term non-invasive ventilation (NIV) is an accepted therapy for sleep-related respiratory disorders and respiratory insufficiency or failure. Increase in the use of long-term NIV may, in part, be driven by an increase in the number of children surviving critical illness with comorbidities. As a result, some children start on long-term NIV as part of transitioning from hospital to home. NIV may be used in acute illness to avoid intubation, facilitate extubation or support tracheostomy decannulation, and to avoid the need for a tracheostomy for long-term invasive ventilation. The decision about whether long-term NIV is appropriate for an individual child and their family needs to be made with care. Preparing for transition from the hospital to home involves understanding how NIV equipment is obtained and set-up, education and training for parents/caregivers, and arranging a plan for clinical follow-up. While planning for these transitions is challenging, the goals of a shorter time in hospital and a child living well at home with their family are important.

The Development of a Chatbot Technology to Disseminate Post-COVID-19 Information: Descriptive Implementation Study.

BACKGROUND: Post-COVID-19, or long COVID, has now affected millions of individuals, resulting in fatigue, neurocognitive symptoms, and an impact on daily life. The uncertainty of knowledge around this condition, including its overall prevalence, pathophysiology, and management, along with the growing numbers of affected individuals, has created an essential need for information and disease management. This has become even more critical in a time of abundant online misinformation and potential misleading of patients and health care professionals. OBJECTIVE: The RAFAEL platform is an ecosystem created to address the information about and management of post-COVID-19, integrating online information, webinars, and chatbot technology to answer a large number of individuals in a time- and resource-limited setting. This paper describes the development and deployment of the RAFAEL platform and chatbot in addressing post-COVID-19 in children and adults. METHODS: The RAFAEL study took place in Geneva, Switzerland. The RAFAEL platform and chatbot were made available online, and all users were considered participants of this study. The development phase started in December 2020 and included developing the concept, the backend, and the frontend, as well as beta testing. The specific strategy behind the RAFAEL chatbot balanced an accessible interactive approach with medical safety, aiming to relay correct and verified information for the management of post-COVID-19. Development was followed by deployment with the establishment of partnerships and communication strategies in the French-speaking world. The use of the chatbot and the answers provided were continuously monitored by community moderators and health care professionals, creating a safe fallback for users. RESULTS: To date, the RAFAEL chatbot has had 30,488 interactions, with an 79.6% (6417/8061) matching rate and a 73.2% (n=1795) positive feedback rate out of the 2451 users who provided feedback. Overall, 5807 unique users interacted with the chatbot, with 5.1 interactions per user, on average, and 8061 stories triggered. The use of the RAFAEL chatbot and platform was additionally driven by the monthly thematic webinars as well as communication campaigns, with an average of 250 participants at each webinar. User queries included questions about post-COVID-19 symptoms (n=5612, 69.2%), of which fatigue was the most predominant query (n=1255, 22.4%) in symptoms-related stories. Additional queries included questions about consultations (n=598, 7.4%), treatment (n=527, 6.5%), and general information (n=510, 6.3%). CONCLUSIONS: The RAFAEL chatbot is, to the best of our knowledge, the first chatbot developed to address post-COVID-19 in children and adults. Its innovation lies in the use of a scalable tool to disseminate verified information in a time- and resource-limited environment. Additionally, the use of machine learning could help professionals gain knowledge about a new condition, while concomitantly addressing patients' concerns. Lessons learned from the RAFAEL chatbot will further encourage a participative approach to learning and could potentially be applied to other chronic conditions.

Exploration of the external and internal factors that affected learning effectiveness for the students: a questionnaire survey.

Learning effectiveness may be affected by internal and external factors, including personal attitude, motivations, learning skills, learning environment and peer pressure. This study sought to explore potential factors on students who majored in medical technology. The 106 students who completed their internship at Chang Gung Memorial Hospital were enrolled in this study. A written questionnaire was analyzed to explore the relationship between potential factors and learning effectiveness. The strength of relationship between the outcome and each factor was evaluated using Spearman correlation coefficients. A multiple linear regression model was constructed to assess how those factors affected learning effectiveness altogether. The results indicated that the learning effectiveness of the students mainly depended on three factors: the "extracurricular studies" and "willingness to cooperate" were positively associated with learning effectiveness. However, the "weakened motivation due to uncertainty" is negatively associated with learning effectiveness. We suggested that the educators can understand the uncertainty of students about the future. Additionally, the projects that require joint cooperation and discussion need to be given. The most important thing is that students should be able to integrate the learning content instead of rote.

The Value of Scientific Publications in Surgical Device Innovation.

BACKGROUND: Clinical trials represent a significant risk in the commercialization of surgical technologies. There is incentive for companies to mitigate their regulatory risk by targeting 510K over Premarket Approval (PMA) pathways in order to limit the scope, complexity and cost of clinical trials. As such, not all companies will publish clinical data in the scientific literature. PURPOSE: We set out to investigate the relationship between scientific publication by surgical device companies and the impact it has on company valuation. We hypothesize that publishing in the scientific literature correlates with success of the surgical device companies as measured by funding. RESEARCH DESIGN: We first obtained a list of surgical device startup companies and their financial deals using the Pitchbook database. Those companies were then cross referenced with the FDA database and the Dimensions database for product registrations and peer reviewed publications, respectively. Analysis was then performed using these query results. STUDY SAMPLE AND DATA COLLECTION: We obtained a list of US surgical device startups financing deals closed between 2010 and 2020 from the Pitchbook database. We queried the Pitchbook for deal dates from January 1, 2010 to January 1, 2020 for deal types spanning early stage investment to IPO. Deals were limited to those conducted in the United States and to the surgical device industry. We queried the FDA database for product registration information associated with each of the companies involved in the deals. We tabulated the number of journal articles associated with surgical device companies using the Dimensions Search API as well as a manual confirmation. RESULTS: Five hundred thirty five (535) deals from 222 companies were found in Pitchbook that met our criteria. Querying the FDA database resulted in 578 registrations associated with these companies. Publications per company ranged widely. CONCLUSIONS: Companies that are able to generate a more numerous publications had correspondingly higher valuations during funding rounds. A subset of outstanding companies were analyzed and at least four factors affect: direct value of publications, indirect valve of publications, survivorship bias, and adoption share; each of which will be discussed in this manuscript.

[Prescription-based digital interventions in psychiatry : Methodology, possible areas of application, and legal framework of digital tools for panic disorder and agoraphobia available in Germany]. / Digitale Gesundheitsanwendungen mit psychotherapeutischem Fokus : Therapieprinzipien, Einsatzmöglichkeiten, rechtlicher Rahmen und Verordnungspraxis am Beispiel der Anwendungen für die Panikstörung und Agoraphobie.

In 2020, prescription-based digital interventions were introduced in Germany. These digital courses have to meet safety and data privacy requirements and must prove positive effects on symptoms and/or other outcome parameters. Interventions are available for a range of mental disorders. For patients with panic disorder and agoraphobia, several applications based on cognitive behavioral therapy have been developed. Within these digital courses, patients can typically access psychoeducational content and practice psychotherapeutic strategies such as exposure therapy. Recent meta-analyses prove the effectiveness of such interventions when compared with waitlist control conditions. According to current German guidelines, digital courses can be used to prepare psychotherapy and as an accompanying tool during psychotherapy. In Germany, physicians and psychotherapist can prescribe digital interventions for outpatients and as a post-hospital treatment..

Distributed Diagnoses Based on Constructing a Private Chain via a Public Network.

Secure online consultations can provide convenient medical services to patients who require experts from different regions. Moreover, this process can save time, which is critical in emergency cases, and cut medical costs. However, medical services need a high level of privacy protection that advances the difficulty of a construction method. It is a good idea to construct a virtual private chain through public networks by means of cryptology and identity verification. For this purpose, novel protocols are proposed to finish the package layout, secure transmission, and authorization. By mining the special characteristics of this application, two different kinds of encryption channels were designed to support the proposed protocol to ensure the secure transmission of data. And Hash values and multiple checking were employed in the transmission package to find the incompleteness of data related to network errors or attacks. Besides the secure communication of medical information, the Extended Chinese Remainder Theorem was utilized to finish the approval during a change in committee in emergency situations. Finally, example case was used to verify the effectiveness of the total methods.

Performance of a new single-use bronchoscope versus a marketed single-use comparator: a bench study.

BACKGROUND: Single-use flexible bronchoscopes eliminate cross contamination from reusable bronchoscopes and are cost-effective in a number of clinical settings. The present bench study aimed to compare the performance of a new single-use bronchoscope (Boston Scientific EXALT Model B) to a marketed single-use comparator (Ambu aScope 4), each in slim, regular and large diameters. METHODS: Three bronchoscopy tasks were performed: water suction and visualization, "mucus" mass (synthetic mucoid mixture) suctioned in 30 s, and "mucus" plug (thicker mucoid mixture) suction. Suction ability, task completion times, and subjective ratings of visualization and overall performance on a scale of one to 10 (best) were compared. All bronchoscopy tasks were completed by 15 physicians representing diversity in specialization including pulmonary, interventional pulmonary, critical care, anesthesia, and thoracic surgery. Each physician utilized the six bronchoscope versions with block randomization by bronchoscope and task. RESULTS: Aspirated mean mass of "mucus" using EXALT Model B Regular was comparable to that for an aScope 4 Large (41.8 ± 8.3 g vs. 41.5 ± 5.7 g respectively, p = 0.914). In comparisons of scopes with the same outer diameter, the aspirated mean mass by weight of water and "mucus" was significantly greater for EXALT Model B than for aScope 4 (p < 0.001 for all three diameters). Mean ratings for visualization attributes were significantly better for EXALT Model B compared to aScope 4 (p-value range 0.001-0.029). CONCLUSION: A new single-use bronchoscope provided strong suction capability and visualization compared to same-diameter marketed single-use comparators in a bench model simulation.

Biodesign program introduction in Japan: promotion of entrepreneurship and viewpoints of education on medical technology innovation.

The Stanford Biodesign program was first introduced in Japan in 2015 at three national universities to develop medical technology innovation and its talent. This study aimed to (1) show the outcomes of leadership talent development, (2) indicate the educational results of the program, and (3) objectively analyze the ways in which the program executed in Japan, effectively promoted entrepreneurship orientation and the origination of new businesses. The latter is especially relevant as Japan has low entrepreneurial awareness and new business entry rates compared to the United States and Europe. Herein, fellows were subjected to questionnaires, interviews, and a survey based on academic papers, extant literature, and treatises issued by the Nihon Biodesign Gakkai (Academic Society of Japan Biodesign). Overall program performance showed notable results, despite indicating a need to improve business-related programs and team learning which is greatly influenced by Japanese culture. An externship program, planned and developed in Japan, was most inspiring and served to expose participants to role models. Comparing Japan Biodesign education elements to factors of general entrepreneurship promotion in Japan, sampled and organized from relevant White Papers, proved its educational effectiveness in entrepreneurship promotion from an objective viewpoint. Within the 4-year timeframe, the results indicated that leadership talent was indeed developed. Medical device innovation should progress through the stages of establishing new ventures, followed by contriving medical devices with novel, impactful value. This study revealed that Japan Biodesign education provides a platform for achieving these goals, despite the challenging Japanese new business environment.

Unsupervised Clustering of Heartbeat Dynamics Allows for Real Time and Personalized Improvement in Cardiovascular Fitness.

VO2max index has a significant impact on overall health. Its estimation through wearables notifies the user of his level of fitness but cannot provide a detailed analysis of the time intervals in which heartbeat dynamics are changed and/or fatigue is emerging. Here, we developed a multiple modality biosignal processing method to investigate running sessions to characterize in real time heartbeat dynamics in response to external energy demand. We isolated dynamic regimes whose fraction increases with the VO2max and with the emergence of neuromuscular fatigue. This analysis can be extremely valuable by providing personalized feedback about the user's fitness level improvement that can be realized by developing personalized exercise plans aimed to target a contextual increase in the dynamic regime fraction related to VO2max increase, at the expense of the dynamic regime fraction related to the emergence of fatigue. These strategies can ultimately result in the reduction in cardiovascular risk.

[LITERATURE REVIEW OF GUIDELINES FOR MEDICAL DEVICES ASSESSMENT].

BACKGROUND: Research on the development and implementation of new principles and methods applicable in the evaluation of medical devices (MD) will allow to accumulate new, as well as the most effective long-used and proven approaches to the clinical and economic evaluation of such an important and extensive class of medical technologies. AIMS: The aim of the study is to identify and analyze developed, approved recommendations for the assessment of MD in the world and domestic practice of assessing health technologies, as well as to find and summarize the current principles, optimal proven and innovative methods for assessing MD for the draft modern recommendations for MD assessment in Moscow. MATERIALS AND METHODS: The sources of the study were scientific articles on the topic of MD assessment and recommendations published over the past five years. RESULTS: A review of publications revealed disunity in the approaches to assessing MD according to international sources, as well as the lack of unified agreed recommendations in Russia. A number of problems and aspects that need to be taken into account when formulating uniform recommendations are clearly defined. CONCLUSION: It is obvious that there is a need to formulate and adopt clear recommendations on the assessment of medical technologies (HTA) of MD, taking into account positive international experience.

[DIGITAL THERAPY TECHNOLOGIES (LITERATURE REVIEW)].

This article presents an analysis of international experience in the implementation of digital therapeutics technologies in health care. The features of digital therapeutics products: their distinction from digital health products and digital medicine are highlighted. An analysis of the global market for digital therapeutics is presented. The aspects of regulation of digital therapeutics and the barriers to its implementation are presented. The importance of digital therapeutics for the transition of health systems to a value-based management model is discussed.