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1.
Surg Clin North Am ; 100(2): 209-218, 2020 Apr.
Artículo en Inglés | MEDLINE | ID: mdl-32169176

RESUMEN

Robotic surgery is growing rapidly, with more than 5000 units in operation worldwide. The most widely used robotic surgery system originated from the concept of telepresence, which led to government-sponsored research and development. The resulting work was taken over by private industry, which led to Food and Drug Administration clearance of the first systems in 2000 to 2001. Robotic surgery offers significant advantages over open surgery; its most important feature is the introduction of a computer into the operating room, with the resulting potential for data collection and analysis that will shape surgical practice in the future.


Asunto(s)
Procedimientos Quirúrgicos Robotizados/historia , Agencias Gubernamentales , Historia del Siglo XX , Historia del Siglo XXI , Humanos , Estados Unidos
2.
Environ Monit Assess ; 192(3): 181, 2020 Feb 17.
Artículo en Inglés | MEDLINE | ID: mdl-32065319

RESUMEN

Since the late 1980s, there has been a US federal mandate to clean up contaminated sites remaining from the Second World War, the Cold War, and abandoned industries. One determinant of cleanup standards for remediation is future land use-how will the land be used and by whom? Land use decisions may be consensus documents developed by site owners, state and federal agencies, and local stakeholders. Often there are competing views and/or claims on how remediated sites should be used, including as open or green space. Large sites are likely to have more ecological heterogeneity within similar land use designations because of differences in climate, geology, topography, and history of human use. This paper uses the Department of Energy's (DOE) Hanford Site as a case study to examine how and whether future land use designations will protect species, species diversity, heterogeneity, and ecosystems once remediation is complete. The objective of this paper is to describe "future land use designations" on a large, complex site (DOE's Hanford Site) and to examine the following: (1) how future land use designations were made and have changed over time, (2) how land use designations included the value of ecological resources, (3) how risk evaluations of ecological resources from remediation were made, and (4) how future land use may affect the health and well-being of ecological resources on site in the post-remediation period. The paper provides a paradigm for integrating ecological protection into future land use designations such that rare and sensitive resources are protected throughout the process. The paradigm includes the following: (1) developing future land use designations, (2) defining resource levels (values), (3) relating resource levels to land use designations and management, (4) defining risk evaluations, (5) determining the likelihood that valuable resources will occur on each land use type after remediation, and (6) evaluating the potential risk to those resources that results from activities allowed under future land use designations. The paper discusses the importance of each step, the implications for protection of ecological resources, and the importance of land use designations in the assessment of risk to ecological resources from both continued monitoring and maintenance by DOE (or other land owners) and the activities permitted by the established future land use designations.


Asunto(s)
Conservación de los Recursos Naturales , Ecosistema , Monitoreo del Ambiente , Ecología , Agencias Gubernamentales , Humanos
7.
Rev Sci Tech ; 38(1): 271-278, 2019 May.
Artículo en Inglés | MEDLINE | ID: mdl-31564723

RESUMEN

Within the last decade, One Health has gained momentum in government agencies, academic institutions, intergovernmental organisations and civil society organisations within Thailand. One Health is an approach of multisectoral and multidisciplinary collaboration that connects human, animal and environmental health sectors to improve the health of all. In 2014, the Coordinating Unit for One Health (CUOH), based within the Thai Ministry of Public Health, was officially established to serve as a focal point within Thailand for One Health collaboration both domestically and internationally. The unit's main functions are to share data, information and resources, and to support One Health activities within the country. The CUOH Steering Committee meets regularly to provide technical and administrative guidance on the functions and directions of the CUOH. A memorandum of understanding on One Health, signed in 2016 by seven Ministries and the Thai Red Cross Society, has strengthened One Health collaboration and provides a formalised channel through which the CUOH can facilitate activities across Ministries and with non-governmental agencies in Thailand.


Asunto(s)
Agencias Gubernamentales , Salud Única , Animales , Agencias Gubernamentales/tendencias , Humanos , Salud Única/normas , Salud Pública , Tailandia
8.
Int J Public Health ; 64(8): 1159-1172, 2019 Nov.
Artículo en Inglés | MEDLINE | ID: mdl-31606749

RESUMEN

OBJECTIVES: This paper examines the opportunities and barriers that the South Australian Health in all Policies (SA HiAP) approach encountered when seeking to establish a whole-of-government response to promoting healthy weight. METHODS: The paper draws on data collected during 31 semi-structured interviews, analysis of 113 documents, and a program logic model developed via workshops to show the causal links between strategies and anticipated outcomes. RESULTS: A South Australian Government target to increase healthy weight was supported by SA HiAP to develop a cross-government response. Our analysis shows what supported and hindered implementation. A combination of economic and systemic framing, in conjunction with a co-benefits approach, facilitated intersectoral engagement. The program logic shows how implementation can be expected to contribute to a population with healthy weight. CONCLUSIONS: The HiAP approach achieved some success in encouraging a range of government departments to contribute to a healthy weight target. However, a comprehensive approach requires national regulation to address the commercial determinants of health and underlying causes of population obesity in addition to cross-government action to promote population healthy weight through regional government action.


Asunto(s)
Política de Salud , Promoción de la Salud , Obesidad , Pérdida de Peso , Gobierno , Agencias Gubernamentales , Humanos , Entrevistas como Asunto , Obesidad/epidemiología , Obesidad/prevención & control , Obesidad/terapia , Formulación de Políticas , Salud Poblacional , Australia del Sur/epidemiología
9.
Artículo en Inglés | MEDLINE | ID: mdl-31540517

RESUMEN

China has established the universal medical insurance system and individual out of pocket costs have decreased, however, the average healthcare expenditure of the Chinese population and the expenses of the whole society have increased substantially. One major challenge which impedes the progress of attaining sustainable development of the social healthcare system in China is that the number of hospital admissions is disproportionate. Superior hospitals are overcrowded, whereas subordinate hospitals are experiencing low admissions. In this paper, we apply the game theory model to coordinate the healthcare supply chain network, which is composed of the government, medical insurance fund, superior hospitals, subordinate hospitals and patients. Especially by taking the reference price effect into account, this paper analyzes different medical insurance reimbursement strategies and their influence on patient choice and the healthcare supply chain network. The result shows that the reference price effect increases the leverage of medical insurance, guides patients' choice, optimizes the allocation of medical resources and reduces the medical expends. In comparison to a decentralized decision- making strategy, a centralized decision- making strategy can stimulate both superior hospital and subordinate hospital's cooperative intentions which benefits the social healthcare system.


Asunto(s)
Prestación de Atención de Salud/organización & administración , Agencias Gubernamentales/organización & administración , Administración Hospitalaria , Programas Nacionales de Salud/organización & administración , China/epidemiología , Prestación de Atención de Salud/economía , Teoría del Juego , Agencias Gubernamentales/economía , Humanos , Reembolso de Seguro de Salud , Programas Nacionales de Salud/economía , Prioridad del Paciente
10.
Bioanalysis ; 11(15): 1387-1388, 2019 Aug.
Artículo en Inglés | MEDLINE | ID: mdl-31490111

RESUMEN

Biography Dr Woolf is currently Executive Director of the regulated PK Bioanalysis Group of Merck Research Laboratories, West Point, PA, USA. He received his BA in Chemistry from LaSalle College in 1982, and a PhD in Analytical Chemistry from Seton Hall University in 1986. From 1986 to 1990, he was a member of the Drug Metabolism/Pharmacokinetics Department of Berlex Laboratories. He joined Merck Research Laboratories in 1990 as a research fellow. Dr Woolf and his group have supported numerous clinical development projects that have led to the successful registration of Merck compounds. Since 1986, he has authored or coauthored over 50 research papers pertaining to bioanalysis and pharmacokinetics. This interview was conducted by Sankeetha Nadarajah, Managing Commissioning Editor of Bioanalysis, at the AAPS ICH-M10 Public Consultation Workshop (Silver Spring, MD, USA), 11 June 2019.


Asunto(s)
Técnicas de Química Analítica , Guías como Asunto , Consenso , Agencias Gubernamentales , Industrias
11.
Artículo en Inglés | MEDLINE | ID: mdl-31408935

RESUMEN

BACKGROUND: Alcohol use is a major risk factor in premature death and disability, especially among youth. Evidence-based policies to prevent and control the detrimental effect of alcohol use have been recommended. In countries with weak alcohol control policies-such as Lebanon, stakeholder analysis provides critical information to influence policy interventions. This paper assesses the views of stakeholders regarding a national alcohol harm reduction policy for youth. METHODS: We interviewed a total of 22 key stakeholders over a period of 8 months in 2015. Stakeholders were selected purposively, to include representatives of governmental and non-governmental organizations and industry that could answer questions related to core intervention areas: affordability, availability, regulation of marketing, and drinking and driving. We analyzed interview transcripts using thematic analysis. RESULTS: Three themes emerged: Inadequacy of current alcohol control policies; weak governance and disregard for rule of law as a determinant of the status quo; and diverting of responsibility towards 'other' stakeholders. In addition, industry representatives argued against evidence-based policies using time-worn strategies identified globally. CONCLUSIONS: Our findings indicate that alcohol harm reduction policies are far from becoming a policy priority in Lebanon. There is a clear need to shift the narrative from victim blaming to structural conditions.


Asunto(s)
Consumo de Bebidas Alcohólicas/legislación & jurisprudencia , Reducción del Daño , Política de Salud/legislación & jurisprudencia , Adolescente , Cerveza , Conducir bajo la Influencia , Agencias Gubernamentales , Humanos , Industrias , Líbano , Mercadeo , Organizaciones , Participación de los Interesados
12.
Regul Toxicol Pharmacol ; 108: 104444, 2019 Nov.
Artículo en Inglés | MEDLINE | ID: mdl-31433998

RESUMEN

One of the important tasks of the German Senate Commission for the Investigation of Health Hazards of Chemical Compounds in the Work Area (known as the MAK Commission) is in the evaluation of a potential for carcinogenicity of hazardous substances at the workplace. Often, this evaluation is critically based on data on carcinogenic responses seen in animal studies and, if positive tumor responses have been observed, this will mostly lead to a classification of the substance under investigation into one of the classes for carcinogens. However, there are cases where it can be demonstrated with a very high degree of confidence that the tumor findings in the experimental animals are not relevant for humans at the workplace and, therefore, the MAK Commission will not classify the respective substance into one of the classes for carcinogens. This paper will summarize the general criteria used by the MAK Commission for the categorization into "carcinogen" and "non-carcinogen" and compare this procedure with those used by other national and international organizations.


Asunto(s)
Contaminantes Ocupacionales del Aire/clasificación , Carcinógenos/clasificación , Guías como Asunto , Contaminantes Ocupacionales del Aire/toxicidad , Animales , Carcinógenos/toxicidad , Alemania , Agencias Gubernamentales , Humanos , Agencias Internacionales , Neoplasias/inducido químicamente , Enfermedades Profesionales/inducido químicamente , Exposición Profesional , Medición de Riesgo , Especificidad de la Especie
13.
Stud Health Technol Inform ; 264: 983-987, 2019 Aug 21.
Artículo en Inglés | MEDLINE | ID: mdl-31438071

RESUMEN

Despite U.S. federal agencies increasing their investment since 1999's release of To Err Is Human, recent reports suggest there is a lack of measurable outcomes in patient safety research. The present study sought to explore the associations between federal incentives of patient safety research and the outcomes from 1995 to 2014, in which the two historical events - the release of To Err Is Human and the American Recovery and Reinvestment Act - were considered in the analysis. We employed Poisson distribution models to provide a longitudinal picture of (1) how the federal incentives drove sponsored research projects; (2) how hot research topics changed over time. Our findings suggested a positive outcome in patient safety research. We also found trending health information technology (HIT) related topics including "natural language processing", "user-computer interface", and "clinical decision support systems" that are prevalent approaches to patient safety research.


Asunto(s)
Sistemas de Apoyo a Decisiones Clínicas , Seguridad del Paciente , Agencias Gubernamentales , Humanos , Estados Unidos
14.
Stud Health Technol Inform ; 264: 1660-1661, 2019 Aug 21.
Artículo en Inglés | MEDLINE | ID: mdl-31438280

RESUMEN

The Department of Defense (DoD) and Department of Veterans Affairs (VA) Infrastructure for Clinical Intelligence (DaVINCI) creates an electronic network between the two United States federal agencies that provides a consolidated view of electronic medical record data for both service members and Veterans. This inter-agency collaboration has created new opportunities for supporting transitions in clinical care, reporting to Congress, and longitudinal research.


Asunto(s)
United States Department of Veterans Affairs , Veteranos , Bases de Datos Factuales , Registros Electrónicos de Salud , Agencias Gubernamentales , Humanos , Inteligencia , Estados Unidos
15.
Int J Mol Sci ; 20(15)2019 Aug 03.
Artículo en Inglés | MEDLINE | ID: mdl-31382625

RESUMEN

Several expedited regulatory review projects for innovative drugs and regenerative medical products have been developed in the US, the EU, and Japan. Each regulatory agency has elaborated an original regulatory framework and adopted regulatory projects developed by the other regulatory agencies. For example, the Food and Drug Administration (FDA) first developed the breakthrough therapy designation, and then the Pharmaceuticals and Medical Devices Agency (PMDA) and European Medicines Agency (EMA) introduced the Sakigake designation and the priority medicines (PRIME) designation, respectively. In addition, the necessity of the product being first development in Japan is the original feature of the Sakigake designation, while actively supporting the development of advanced-therapy medicinal products (AMTPs) by academia or small/medium-sized sponsors is the original feature of the PRIME; these particular features are different from the breakthrough therapy designation in the US. In this review article, flexible and expedited review processes for new drugs, and cell and gene therapies in the US, the EU, and Japan are described. Moreover, all the drugs and regenerative medical products that were granted conditional approval or Sakigake designation in Japan are listed and analyzed herein.


Asunto(s)
Terapia Genética/tendencias , Medicina Regenerativa/tendencias , Terapias en Investigación/tendencias , Europa (Continente)/epidemiología , Agencias Gubernamentales/tendencias , Humanos , Japón/epidemiología , Estados Unidos/epidemiología , United States Food and Drug Administration
17.
Q J Nucl Med Mol Imaging ; 63(2): 170-182, 2019 Jun.
Artículo en Inglés | MEDLINE | ID: mdl-31298017

RESUMEN

Radium-223 (223Ra) is a life-prolonging treatment in symptomatic men with metastatic castrate-resistant prostate cancer (mCRPC) and bone metastases, but no visceral disease, regardless of prior treatment with docetaxel. Together with four other drugs (i.e. abiraterone, cabazitaxel, docetaxel, enzalutamide), it has been available for clinical use since 2013 and has been shown to also provide benefits in quality-of-life and societal benefits. However, in 2018 the European Medicines Agency ruled to restrict the use of radium-223 to a more advanced disease setting after at least two lines of one or the other life-prolonging agent. This decision was triggered by the results of a safety interim analysis of ERA-223, a trial investigating the combination of 223Ra and abiraterone versus abiraterone alone in patients without prior chemotherapy (with the exception of adjuvant treatment) with asymptomatic bone predominant mCRPC. That safety analysis showed an early increased risk of fracture and deaths with the combination treatment. This review critically appraises the available and emerging data with 223Ra treatment in an attempt to assess the appropriateness of the revised label of radium-223.


Asunto(s)
Agencias Gubernamentales , Neoplasias de la Próstata Resistentes a la Castración/patología , Neoplasias de la Próstata Resistentes a la Castración/radioterapia , Radio (Elemento)/uso terapéutico , Europa (Continente) , Humanos , Masculino , Metástasis de la Neoplasia , Radio (Elemento)/efectos adversos , Seguridad
18.
Gynecol Oncol ; 154(3): 616-621, 2019 09.
Artículo en Inglés | MEDLINE | ID: mdl-31324452

RESUMEN

OBJECTIVE: Patients are increasingly using online materials to learn about gynecologic cancer. Providers can refer patients to online educational materials produced by a number of different major medical organizations and pharmacology companies. The National Institutes of Health (NIH) and the American Medical Association (AMA) recommend that patient educational materials (PEMs) are written between a sixth and eighth grade reading level. In this study, we assess the readability of online PEMs published by major medical organizations and industry partners. METHODS: Websites from twelve websites providing educational materials for gynecologic oncology patients were surveyed. Online PEMs were identified and analyzed using seven validated readability indices. One-way ANOVA and Tukey's Honestly Significant Difference (HSD) post-hoc analysis were performed to detect differences in readability between publishers. RESULTS: Two-hundred and sixty PEMs were included in this analysis. Overall, PEMs were written at a mean 11th±0.6 grade reading level. Only 6.5% of articles were written at the AMA/NIH recommended reading grade level of 6th to 8th grade or below. ANOVA demonstrated a significant difference in readability between publishing associations (p<0.01). PEMs from the Centers for Disease Control had a mean 9th±1.2 grade reading level and were significantly lower than all other organizations. PEMs from The Foundation for Women's Cancer had a mean 13th±1.8 grade reading level and were significantly higher than most other organizations. PEMs from pharmaceutical companies (mean readability=10.1±1.1, N=30) required the lowest reading grade level and were significantly more readable than those from governmental organizations (11.1±1.7, p<0.05) and nonprofit medical associations (12.4±1.7, p<0.01) in ANOVA and Tukey-Kramer post hoc analysis. CONCLUSIONS: Gynecologic oncology PEMs available from twelve major organization websites are written well above the recommended sixth to eighth grade reading difficulty level.


Asunto(s)
Neoplasias de los Genitales Femeninos , Internet/normas , Educación del Paciente como Asunto/normas , Lectura , Comprensión , Industria Farmacéutica , Femenino , Agencias Gubernamentales , Alfabetización en Salud , Humanos , Organizaciones sin Fines de Lucro , Educación del Paciente como Asunto/métodos
19.
Nutrients ; 11(7)2019 Jul 12.
Artículo en Inglés | MEDLINE | ID: mdl-31336978

RESUMEN

Background: In Japan, a new type of foods with health claims, called Foods with Function Claims (FFC), was introduced in April 2015 in order to make more products available that are clearly labeled with certain health functions. Regarding substantiating product effectiveness, scientific evidence for the proposed function claims must be explained by systematic reviews (SRs), but the quality of SRs was not clear. The objectives of this review were to assess the quality of SRs based on the FFC registered on the Consumer Affairs Agency (CAA) website in Japan, and to determine whether the CAA's verification report in 2016 was associated with improvement in the quality of SRs. Methods: We evaluated the reporting quality of each SR by the AMSTAR checklist on methodological quality. We searched the database from 1 April to 31 October 2015 as the before-SR and from 1 July 2017 to 31 January 2018 as the after-SR. Results: Among the 104 SRs reviewed, 96 final products were included: 51 (53.1%) were supplements, 42 (43.8%) were processed foods without supplements, and 3 (3.1%) were fresh foods. Of the 104 SRs, 92 (88.5%) were qualitative reviews (i.e., without meta-analysis) and 12 (11.5%) performed a meta-analysis. The average quality score of before-SRs and after-SRs was 6.2 ± 1.8 and 5.0 ± 1.9, respectively, a statistically significant decrease (p < 0.001). Conclusion: Overall, the methodology and reporting quality of after-SRs based on the FFC were poorer than those of before-SRs. In particular, there were very poor descriptions and/or implementations of study selection and data extraction, search strategy, evaluation methods for risk of bias, assessment of publication bias, and formulating conclusions based on methodological rigor and scientific quality of the included studies.


Asunto(s)
Alimentos Funcionales , Revisiones Sistemáticas como Asunto , Sesgo , Agencias Gubernamentales , Humanos , Japón , Proyectos de Investigación
20.
Int J Health Policy Manag ; 8(5): 261-271, 2019 05 01.
Artículo en Inglés | MEDLINE | ID: mdl-31204442

RESUMEN

BACKGROUND: The Joint United Nations Programme on HIV/AIDS (UNAIDS) has recently set the ambitious "90-90-90 target" of having 90% of people living with HIV (PLHIV) know their status, receive antiretroviral therapy (ART), and achieve viral suppression by 2020. This ambitious new goal is occurring in a context of global "scale-down" following nearly a decade of heightened investment in HIV prevention and treatment efforts. Arguably international goals spur action, however, setting unrealistic goals that do not take weak health systems and variations in the nature of the epidemic across countries into consideration may set them up for failure in unproductive ways that lead to a decline in confidence in global governance institutions. This study explores how policy actors tasked with implementing HIV programs navigate the competing demands placed upon them by development targets and national politics, particularly in the current context of waning international investments towards HIV. METHODS: To examine these questions, we interviewed 29 key informants comprising health experts in donor organizations and government employees in HIV programs in Pakistan, a country where HIV programs must compete with other issues for attention. Themes were identified inductively through an iterative process and findings were triangulated with various data sources and existing literature. RESULTS: We found both political and governance challenges to achieving the target, particularly in the context of the global HIV scale-down. Political challenges included, low and heterogeneous political commitment for HIV and a conservative legal environment that contributed towards a ban on opiate substitution therapy, creating low treatment coverage. Governance challenges includedstrained state and non-governmental organization (NGO) relations creating a hostile service delivery environment, weak bureaucratic and civil society capacity contributing to poor regulation of the health infrastructure, and resource mismanagement on both the part of the government and NGOs. CONCLUSION: Our findings suggest that in a context of waning international attention to HIV, policy actors on the ground face a number of practical hurdles to achieving the ambitious targets set out by international agencies. Greater attention to the political and governance challenges of implementing HIV programs in low- and middle-income countries (LMICs) could help technical assistance agencies to develop more realistic implementation plans.


Asunto(s)
Infecciones por VIH/prevención & control , Política de Salud , Política , Abuso de Sustancias por Vía Intravenosa/prevención & control , Personal Administrativo , Prestación de Atención de Salud/organización & administración , Agencias Gubernamentales , Infecciones por VIH/terapia , Humanos , Relaciones Interinstitucionales , Entrevistas como Asunto , Pakistán/epidemiología
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