2021 Update on Safety of Magnetic Resonance Imaging: Joint Statement From Canadian Cardiovascular Society/Canadian Society for Cardiovascular Magnetic Resonance/Canadian Heart Rhythm Society.

Magnetic resonance imaging (MRI) is often considered the gold-standard test for characterizing cardiac as well as noncardiac structure and function. However, many patients with cardiac implantable electronic devices (CIEDs) and/or severe renal dysfunction are unable to undergo this test because of safety concerns. In the past 10 years, newer-generation CIEDs and gadolinium-based contrast agents (GBCAs) as well as coordinated care between imaging and heart rhythm device teams have mitigated risk to patients and improved access to MRI at many hospitals. The purpose of this statement is to review published data on safety of MRI in patients with conditional and nonconditional CIEDs in addition to patient risks from older and newer GBCAs. This statement was developed through multidisciplinary collaboration of pan-Canadian experts after a relevant and independent literature search by the Canadian Agency for Drugs and Technologies in Health. All recommendations align with the Grading of Recommendations Assessment, Development and Evaluation (GRADE) system. Key recommendations include: (1) the development of standardized protocols for patients with a CIED undergoing MRI; (2) patients with MRI nonconditional pacemakers and pacemaker dependency should be programmed to asynchronous mode and those with MRI nonconditional transvenous defibrillators should have tachycardia therapies turned off during the scan; and (3) macrocyclic or newer linear GBCAs should be used in preference to older GBCAs because of their better safety profile in patients at higher risk of nephrogenic systemic fibrosis.

Cost-benefit model for multi-generational high-technology products to compare sequential innovation strategy with quality strategy.

In the rapidly changing high-tech industry, firms that produce multi-generational products struggle to consistently introduce new products that are superior in innovativeness. However, developing innovative products in a short time sequence period is likely to cause quality problems. Therefore, considering time and resource constraints, two kinds of strategies are commonly employed: sequential innovation strategy, sequentially introducing a new generation of technology product at every launch interval, ensuring timely innovativeness but with relatively uncertain quality, or quality strategy, intermittently introducing a new generation of products, together with a derivative model between generations to enhance the quality. In this study, we propose a framework for a cost-benefit analysis that compares these two strategies by considering competition between firms within a generation as well as that within a firm across multiple generations (i.e., cannibalization) throughout the launch cycle of high-tech products. We apply our proposed framework to the smartphone market and conduct a sensitivity analysis. The results are expected to contribute to strategic decision-making related to the introduction of multi-generational technology products.

Innovation in Pain Rehabilitation Using Co-Design Methods During the Development of a Relapse Prevention Intervention: Case Study.

BACKGROUND: Many intervention development projects fail to bridge the gap from basic research to clinical practice. Instead of theory-based approaches to intervention development, co-design prioritizes the end users' perspective as well as continuous collaboration between stakeholders, designers, and researchers throughout the project. This alternative approach to the development of interventions is expected to promote the adaptation to existing treatment activities and to be responsive to the requirements of end users. OBJECTIVE: The first objective was to provide an overview of all activities that were employed during the course of a research project to develop a relapse prevention intervention for interdisciplinary pain treatment programs. The second objective was to examine how co-design may contribute to stakeholder involvement, generation of relevant insights and ideas, and incorporation of stakeholder input into the intervention design. METHODS: We performed an embedded single case study and used the double diamond model to describe the process of intervention development. Using all available data sources, we also performed deductive content analysis to reflect on this process. RESULTS: By critically reviewing the value and function of a co-design project with respect to idea generation, stakeholder involvement, and incorporation of stakeholder input into the intervention design, we demonstrated how co-design shaped the transition from ideas, via concepts, to a prototype for a relapse prevention intervention. CONCLUSIONS: Structural use of co-design throughout the project resulted in many different participating stakeholders and stimulating design activities. As a consequence, the majority of the components of the final prototype can be traced back to the information that stakeholders provided during the project. Although this illustrates how co-design facilitates the integration of contextual information into the intervention design, further experimental testing is required to evaluate to what extent this approach ultimately leads to improved usability as well as patient outcomes in the context of clinical practice.

Nursing work in assisted human reproduction: between technology and humanization.

OBJECTIVES: To analyze the social representations of nurses who work with assisted human reproduction about the operation with reproductive biotechnologies. METHODS: Qualitative approach, supported by the Theory of Social Representations, with sixteen participants. Individual, semi-structured interviews, analyzed through the Alceste software. RESULTS: Pragmatic elements related to nurses' performance from a professional, institutional, and public policy perspective in reproductive biotechnologies emerged, demonstrating the practical dimension of these representations. The characteristics of the professional to act in this area were addressed, showing the lack of information and search for scientificity; precarious perception of the organizational structure of health services; and attributions of nursing care arising from the health care practice in assisted human reproduction. FINAL CONSIDERATIONS: Social representation is anchored in the link between technology/medicalization and humanization/reception regarding reproductive biotechnologies. Working in assisted human reproduction involves a new and challenging nursing care, requiring specific and ethical knowledge.

Technology-supported lifestyle interventions to improve maternal-fetal outcomes in women with gestational diabetes mellitus: A meta-analysis.

BACKGROUND: The increasing incidence of gestational diabetes mellitus (GDM) is a global health problem. Lifestyle interventions have been recognized as effective measures to enhance maternal and child health. Traditional education approaches, personalized consultation and home visits to promote change in patients' lifestyle are limited by cost, lack of resources and inability to provide broad coverage. The increased use of technological approaches can cross these barriers. OBJECTIVES: The meta-analysis aimed to evaluate the effectiveness of technology-supported lifestyle interventions for women with gestational diabetes mellitus. METHODS: Databases that were reviewed included the Cochrane Library, PubMed, Web of Science, EBSCO, Embase, Medline, CINAHL and ClinicalTrials.gov. from inception to September 2019. Randomized controlled trials (RCTs) of technology-supported lifestyle interventions used for women with gestational diabetes mellitus (GDM) were identified. Two reviewers independently assessed each study using Cochrane Collaboration's tool. Maternal-fetal outcomes as well as weight gain in pregnancy and maternal blood glucose were presented as relative risks (RR) or a mean difference (MD). RESULTS: Of the 3993 articles reviewed, ten RCTs involving 979 women were included. Technology-supported lifestyle interventions reduced pregnancy weight gain (MD = -1.55, 95% CI = [-1.81 to -1.29], P < 0.001) and mean (1-h and 2-h) postprandial blood glucose (MD = -0.31, 95% CI = [-0.58 to -0.03], P = 0.03), with low heterogeneity of 36% and 18%, respectively. No evidence of significant effect existed on other maternal-fetal outcomes, such as weeks of gestation at delivery, caesarean birth, pre-eclampsia/gestational hypertension, instrumental vaginal birth, premature delivery, newborn weight, neonatal hypoglycemia, large-for-gestational age, fetal macrosomia, NICU admission and respiratory morbidity (I2 ranging from 0% to 51%). No significant improvement was noted in glycosylated hemoglobin (HbA1c) and fasting blood glucose (FBG), with strong heterogeneity of 95% and 84%, respectively. CONCLUSIONS: Technology-supported lifestyle interventions are associated with reducing pregnancy weight gain and mean (1-h and 2-h) postprandial blood glucose in women with GDM. Well-designed research studies are needed to identify the full potential of technology-supported lifestyle interventions, especially interventions guided by theoretical models.

Industrial Biotechnology: To What Extent Is Responsible Innovation on the Agenda?

The UK Industrial Biotechnology (IB) Strategy presents a consistent plan to develop the IB sector but fails to endorse an innovation process that allows for input from multiple publics. This could be disadvantageous for the bioeconomy: there are notable cases where negligence to address societal dimensions has caused innovation failure.

Population Aging, Technological Innovation, and the Growth of Health Expenditure: Evidence From Patients With Type 2 Diabetes in Taiwan.

OBJECTIVES: As populations are growing older, the prevalence of chronic diseases such as diabetes mellitus is rapidly increasing. Meanwhile, many new drugs are introduced each year as a result of technological advances. This study uses diabetes as an example to investigate the relative importance of population aging and technological innovation in accounting for the growth of health expenditures. METHODS: The retrospective cohort study was conducted based on claims data covering 1997 to 2006 taken from Taiwan's National Health Insurance. Patients were selected based on whether they received antidiabetic drugs. Growth in health expenditure was decomposed into 3 parts: number of patients, mean treatment cost, and the interaction between the change in the mean treatment cost and the change in the number of patients. RESULTS: The results indicated that 75% of the growth in expenditures for treating diabetic patients is attributable to the effect of population aging, as reflected by the increase in the diabetes prevalence rate (45%) and disease severity (30%). Technological innovation, in the form of treatment substitution (10%) and treatment expansion effects (15%), accounted for only about 25% of the growth in expenditures for treating diabetic patients. CONCLUSIONS: Population aging plays a more significant role than technological innovation in driving up health expenditures for the treatment of diabetic patients. This suggests that population aging may contribute significantly to the future growth of the healthcare sector in Asian countries such as Taiwan.

Diabetes Digital App Technology: Benefits, Challenges, and Recommendations. A Consensus Report by the European Association for the Study of Diabetes (EASD) and the American Diabetes Association (ADA) Diabetes Technology Working Group.

Digital health technology, especially digital and health applications ("apps"), have been developing rapidly to help people manage their diabetes. Numerous health-related apps provided on smartphones and other wireless devices are available to support people with diabetes who need to adopt either lifestyle interventions or medication adjustments in response to glucose-monitoring data. However, regulations and guidelines have not caught up with the burgeoning field to standardize how mobile health apps are reviewed and monitored for patient safety and clinical validity. The available evidence on the safety and effectiveness of mobile health apps, especially for diabetes, remains limited. The European Association for the Study of Diabetes (EASD) and the American Diabetes Association (ADA) have therefore conducted a joint review of the current landscape of available diabetes digital health technology (only stand-alone diabetes apps, as opposed to those that are integral to a regulated medical device, such as insulin pumps, continuous glucose monitoring systems, and automated insulin delivery systems) and practices of regulatory authorities and organizations. We found that, across the U.S. and Europe, mobile apps intended to manage health and wellness are largely unregulated unless they meet the definition of medical devices for therapeutic and/or diagnostic purposes. International organizations, including the International Medical Device Regulators Forum and the World Health Organization, have made strides in classifying different types of digital health technology and integrating digital health technology into the field of medical devices. As the diabetes digital health field continues to develop and become more fully integrated into everyday life, we wish to ensure that it is based on the best evidence for safety and efficacy. As a result, we bring to light several issues that the diabetes community, including regulatory authorities, policy makers, professional organizations, researchers, people with diabetes, and health care professionals, needs to address to ensure that diabetes health technology can meet its full potential. These issues range from inadequate evidence on app accuracy and clinical validity to lack of training provision, poor interoperability and standardization, and insufficient data security. We conclude with a series of recommended actions to resolve some of these shortcomings.

7. Diabetes Technology: Standards of Medical Care in Diabetes-2020.

The American Diabetes Association (ADA) "Standards of Medical Care in Diabetes" includes the ADA's current clinical practice recommendations and is intended to provide the components of diabetes care, general treatment goals and guidelines, and tools to evaluate quality of care. Members of the ADA Professional Practice Committee, a multidisciplinary expert committee (https://doi.org/10.2337/dc20-SPPC), are responsible for updating the Standards of Care annually, or more frequently as warranted. For a detailed description of ADA standards, statements, and reports, as well as the evidence-grading system for ADA's clinical practice recommendations, please refer to the Standards of Care Introduction (https://doi.org/10.2337/dc20-SINT). Readers who wish to comment on the Standards of Care are invited to do so at professional.diabetes.org/SOC.

Nursing work in assisted human reproduction: between technology and humanization / El trabajo del enfermero en reproducción humana asistida: entre la tecnología y la humanización / Trabalho do enfermeiro em reprodução humana assistida: entre tecnologia e humanização

ABSTRACT Objectives: To analyze the social representations of nurses who work with assisted human reproduction about the operation with reproductive biotechnologies. Methods: Qualitative approach, supported by the Theory of Social Representations, with sixteen participants. Individual, semi-structured interviews, analyzed through the Alceste software. Results: Pragmatic elements related to nurses' performance from a professional, institutional, and public policy perspective in reproductive biotechnologies emerged, demonstrating the practical dimension of these representations. The characteristics of the professional to act in this area were addressed, showing the lack of information and search for scientificity; precarious perception of the organizational structure of health services; and attributions of nursing care arising from the health care practice in assisted human reproduction. Final considerations: Social representation is anchored in the link between technology/medicalization and humanization/reception regarding reproductive biotechnologies. Working in assisted human reproduction involves a new and challenging nursing care, requiring specific and ethical knowledge.

RESUMEN Objetivos: Analizar las representaciones sociales del enfermero que trabaja con reproducción humana asistida acerca del trabajo con biotecnologías reproductivas. Métodos: Estudio de tipo cualitativo basándose en la Teoría de las Representaciones Sociales, realizado con 16 participantes. Las entrevistas individuales, semiestructuradas, se analizaron por medio del software Alceste. Resultados: Se desvelaron los elementos pragmáticos relacionados al desempeño del enfermero desde la perspectiva profesional, institucional y de conformación de las políticas públicas en biotecnologías reproductivas, demostrando la dimensión práctica de esas representaciones. Se abordaron las características del profesional para actuar en este campo, demostrando carencia de información y búsqueda del valor científico; la percepción precaria de la estructura organizativa de los servicios de salud; y las funciones del cuidado del enfermero provenientes de la práctica asistencial en reproducción humana asistida. Consideraciones finales: La representación social se fundamenta en el enlace entre la tecnología/medicalización y la humanización/acogida con relación a las biotecnologías reproductivas. El trabajo en reproducción humana asistida implica un nuevo y desafiante cuidado de la enfermería y le exige un conocimiento específico y de la ética.

RESUMO Objetivos: Analisar as representações sociais do enfermeiro que trabalha com reprodução humana assistida acerca da atuação com biotecnologias reprodutivas. Métodos: Abordagem qualitativa sustentada pela Teoria das Representações Sociais com dezesseis participantes. Entrevista individual, semiestruturada, analisada pelo software Alceste. Resultados: Emergiram elementos pragmáticos relacionados à atuação do enfermeiro na perspectiva profissional, institucional e de conformação das políticas públicas em biotecnologias reprodutivas, demonstrando a dimensão prática dessas representações. Abordaram-se as características do profissional para atuar nesta área, demonstrando carência de informação e busca pela cientificidade; percepção precária da estrutura organizacional dos serviços de saúde; e atribuições do cuidado do enfermeiro que advêm da prática assistencial em reprodução humana assistida. Considerações finais: A representação social ancora-se no elo entre a tecnologia/medicalização e a humanização/acolhimento em relação às biotecnologias reprodutivas. O trabalho em reprodução humana assistida envolve um novo e desafiador cuidado de enfermagem e exige conhecimento específico e ético.

Personalised Nutrition Technologies and Innovations: A Cross-National Survey of Registered Dietitians.

BACKGROUND: Commercial technology-enabled personalised nutrition is undergoing rapid growth, yet its uptake in dietetics practice remains low. This survey sought the opinions of dietetics practitioners on personalised nutrition and related technologies to understand the facilitators and barriers to its application in practice. METHOD: A cross-section of registered dietitians were recruited in the USA, UK, Australia, Canada, Israel, Mexico, Portugal, Spain, and South Africa. The questionnaire sought their views on the risks of genetics technology, the ethics of genetic testing, the usefulness of new personalised nutrition technologies, entrepreneurism, and the perceived importance of new technologies to dietetics. Validated scales were included to assess personality (Big Five) and self-efficacy (NGSEI). The survey was available in English, Spanish, and Portuguese. Regression analyses were performed to identify factors associated with the integration of nutrigenetic testing into practice, and to identify factors associated with the perceived importance of bio-information, and mobile technology to dietetics practice. RESULTS: A total of 323 responses (response rate 19.7%) were analysed. Dietetics practitioners who had integrated personalised nutrition technology into practice perceived technologies to be less risky (p = 0.02), biotechnology to be more important (p < 0.01), and professional skills to be less important (p = 0.04) than those who had not. They were also more likely to see themselves as entrepreneurs (p < 0.01) and to perceive lower risks to be associated with technology (p < 0.01). Practitioners of nutrigenetics were lower on neuroticism (p < 0.01) and higher on self-efficacy (p < 0.01), extraversion (p < 0.01), and agreeableness (p < 0.01). A higher perceived importance of biotechnology to dietetics practice was associated with higher perceived usefulness of omics tests (p < 0.01). Perceived importance of information technology was associated with the perceived importance of biotechnology (p < 0.01). Mobile technology was perceived as important by dietitians with the highest level of education (p = 0.02). CONCLUSIONS: For dietitians to practice technology-enabled personalised nutrition, training will be required to enhance self-efficacy, address the risks perceived to be associated with new technologies, and instil an entrepreneurial mindset.

Assisted reproductive technologies for endangered species conservation: developing sophisticated protocols with limited access to animals with unique reproductive mechanisms.

Assisted reproductive technologies (ARTs) have been proposed as a means of overcoming the significant challenges of managing small, isolated populations of endangered species in zoos. However, efficient protocols for ARTs do not exist for most endangered species. This review will focus on research efforts to characterize unique reproductive mechanisms and develop species-specific ARTs. Central to these studies are assays to measure steroid metabolites in urine or feces and/or training programs to allow unrestrained blood collections and ultrasound evaluations. The resulting information about estrous cycle dynamics, combined with studies of semen collection and processing, provides the foundation for the development of artificial insemination (AI). In vitro fertilization and embryo transfer are also discussed in relation to the advantages these techniques could provide relative to AI, as well as the significant challenges involved with technologies that require oocytes and embryos. Finally, an argument is made for additional research of nontraditional model species (e.g., domestic cats and dogs) and the development of novel models representing unique taxa. Whether these species are studied by zoo-based researchers with the expressed intent of developing ARTs for conservation or academic scientists interested in basic biology, the resulting information will provide a unique, evolutionary perspective on reproduction that could have wide-reaching benefits. The more information we have available, the better our chances will be of developing effective ARTs and making a difference in conservation efforts for endangered species.

Early assessment of innovation in a healthcare setting.

OBJECTIVES: Early assessment can assist in allocating resources for innovation effectively and produce the most beneficial technology for an institution. The aim of the present study was to identify methods and discuss the analytical approaches applied for the early assessment of innovation in a healthcare setting. METHODS: Knowledge synthesis based on a structured search (using the MEDLINE, Embase, and Cochrane databases) and thematic analysis was conducted. An analytical framework based on the stage of innovation (developmental, introduction, or early diffusion) was applied to assess whether methods vary according to stage. Themes (type of innovation, study, analysis, study design, method, and main target audience) were then decided among the authors. Identified methods and analysis were discussed according to the innovation stage. RESULTS: A total of 1,064 articles matched the search strategy. Overall, thirty-nine articles matched the inclusion criteria. The use of methods has a tendency to change according to the stage of innovation. Stakeholder analysis was a prominent method in the innovation stages and particularly in the developmental stage, as the introduction and early diffusion stage has more availability of data and may apply more complex methods. Barriers to the identified methods were also discussed as all of the innovation stages suffered from lack of data and substantial uncertainty. CONCLUSIONS: Although this review has identified applicable approaches for early assessment in different innovation stages, research is required regarding the value of the available data and methods and tools to enhance interactions between different parties at different stages of innovation.

A Type 1 diabetes technology pathway: consensus statement for the use of technology in Type 1 diabetes.

In both adults and children with diabetes, technologies such as continuous subcutaneous insulin infusion using insulin pumps and continuous glucose monitoring can help improve diabetes control, reduce hypoglycaemia and improve quality of life. Access to these technologies in the UK is very variable. Some technologies are recommended by the National Institute for Health and Care Excellence, while others have not been appraised, and new technologies are emerging all the time. Additionally, different guidelines for adults and children further complicate access to diabetes technology in the transition from paediatric to adult care. Against this background, Diabetes UK and NHS England have brought together a multidisciplinary group of experts, including clinicians and people with diabetes, to develop this consensus guideline, combining the different technologies into a common pathway to aid clinical and policy decision-making. We created a pathway that supports the incremental addition of technology as monotherapy and then dual therapy in the same way that we incrementally add in therapeutic agents to support people with Type 2 diabetes to achieve their personalized glycaemic targets. The pathway emphasizes the importance of structured education, specialist support and appropriate access to psychological therapies, as essential pillars for optimized use of diabetes-related technology, and recommends the re-evaluation of its use when the individual is unable either to use the technology appropriately or to achieve the intended outcomes. This pathway is endorsed by UK-wide clinical and patient associations and we recommend that providers and commissioners use it to ensure the right individual with diabetes has access to the right technology in a timely way to help achieve better outcomes.

Why Cities Survive and Companies Die.

As systems evolve over time, their natural tendency is to become increasingly more complex. Studies in the field of complex systems have generated new perspectives on the application of management strategies in health systems. Much of this research appears as a natural extension of the cross-disciplinary field of systems theory. This article is the 5th in a series of articles that focuses on why technological complexity is increasing and strategies nurse administrators can use to successfully implement change in the face of it.

Health Technology Assessments for Flash Glucose Monitoring and How to Use Them in Everyday Clinical Practice.

BACKGROUND: Various health technology assessment (HTA) agencies review new medical devices worldwide, and their recommendations can be useful in guiding clinical decision making. However, different agencies use different processes and methodologies, resulting in variation in recommendations. OBJECTIVES: The objectives were to review full HTAs for a new technology for diabetes management, flash glucose monitoring (FGM), with the aim of summarizing similarities/differences in processes, methodologies, and recommendations from the perspective of everyday clinical practice. METHODS: A literature review was conducted using online HTA resources. RESULTS: Four full HTAs were identified (Canary Islands, France, Catalunya, and Norway); one issued a conditional recommendation for patients with type 1 diabetes mellitus (T1DM) with controlled glycated hemoglobin (HbA1c) (Spain; Canary Islands), one issued a broader recommendation for patients with T1DM and T2DM (France), and two reported that there was insufficient evidence to support a recommendation (Spain [Catalunya] and Norway). The most comprehensive and stringent of the available HTAs were those in the Canary Islands and Norway, which included systematic literature reviews (SLRs), consultation with patient groups and clinicians, GRADE evidence quality assessments, and full economic models. Comprehensive HTAs either did not recommend FGM (Norway) or restricted the recommendation to a small subpopulation of the overall diabetes population (Canary Islands). CONCLUSION: HTAs represent a valuable additional resource for clinicians to consider alongside clinical evidence, guidelines, and consensus papers; however, interpreting recommendations requires an understanding of the processes behind these recommendations. In this review, comprehensive HTAs either recommended for a selected subpopulation based on RCT evidence or found insufficient evidence for a recommendation.