National Approval Research Articles

Trends and temporal-spatial distribution of fiber quality in the national cotton variety regional trials.

This study applied a grey predicting model to predict the trend of cotton fiber quality for next 5 and 10 years in the Yellow River Valley (YeRV), the Yangtze River Valley (YaRV) and the Northwest Inland Region (NWIR) based on the data set from the fiber quality traits of candidate cultivars in National Cotton Variety Regional Trials during 2005-2014. The temporal and spatial distributions of cotton trails in the three major cotton producing regions were analyzed. The results showed that the overall fiber quality of the Regional Cotton Variety Trials was improved during 2005-2014. Fiber length showed excellence and the distribution of threshold increased to 27.0-32.0 mm, and the fiber length of most cultivars reached 29 or 30 mm. Fiber strength also showed an increase trend. The proportion of high level (31.0 cN·tex-1) cultivars in YaRV was as high as 61.1% in 2011. Micronaire was significantly different among the three major cotton producing regions. In YeRV, micronaire was increased from class B2(4.3-4.9) to class C2(≥5.0). In YaRV, it maintained in a high level of class C2; while it performed excellent in class A (3.7-4.2) and B2 (4.3-4.9) in NWIR. As a comprehensive fiber quality trait, spinning consistency index decreased from NWIR, YaRV to YeRV, and was ranged from 130 to 149, which was suitable for 40-50 spun yarn and accounted for about 80.0% over the total. We concluded that NWIR had the best fiber quality, followed by YaRV and YeRV in recent ten years. In the near future, fiber quality in the regional cotton variety trails would slightly increase in YaRV, but significantly decrease in YeRV and NWIR. These changes should be highly concerned for breeders, the committee of National Cotton Variety Regional Trials and approval of management department in China.

Evolution of the registration regulations for proprietary Chinese medicines in China

In this review, we provide a comprehensive overview on the registration of proprietary Chinese medicines (PCMs) in China over the past century by examining published literature and historical data. We will examine this evolving administrative practice for PCMs registration in China, which is divided to the following five stages: (1) initial measures (1915–1948); (2) early development (1949–1965); (3) provincial approval and trial implementation of the “approval number” system (1966–1984); (4) legislation and cleanup (1985–1999); and (5) centralized national approval (2000 until now), offering a panoramic view on the characteristics of PCMs registration management in China.

Financing and New Product Decisions of Private and Publicly Traded Firms

We exploit Medicare national coverage reimbursement approvals as a quasi-natural experiment to investigate how the financing decisions of private and publicly traded firms respond to changes in investment opportunities. We find that publicly traded companies increase their external financing and their subsequent product introductions by more than private companies in response to national coverage approvals. Private equity financing is the primary source of the increased financing for public firms. We show that the stock characteristics of publicly traded firms, such as liquidity and price informativeness, and product market competition are important factors in explaining their financing advantage.

Identification of Chinese Medicine Constitution in Public Health Services.

Public health is the science and art of preventing disease, prolonging life and prompting physical and mental health through evaluation, policy development and sanitary measures. The development of public health has become an important part of health care reform in China, and it requires the participation of Chinese medicine (CM) in the practice of public health. This study analyzed the problems of CM services in public health, suggested that the identification of CM constitution could propose an application paradigm of CM services in public health, and described from aspects of theory, technology and application. The identification of CM constitution gained national approval and support of government and industry. With the application and popularization of this technology, it will promote the establishment of characteristic CM preventive care system and the development of public health.

Implementing the International Convention on the Rights of Persons with Disabilities in Qatar: From charity to human rights

A historically marginalized and overlooked segment of the general population worldwide, persons with disabilities have long struggled with discrimination, inequality and even maltreatment. They have often been treated as societal outcasts and their disabilities treated as medical conditions that need to be “fixed” in order for the individual to join the rest of society. Throughout the last three decades, this approach has been steadily changing towards an inclusive model whereas persons with disabilities are recognized as a protected group of citizens who are due the same complete human rights as the general population. This change has become particularly evident with the United Nation's approval of the International Convention on the Rights of Persons with Disabilities (CRPD) in 2006. However, the strides made by the approval of the CRPD are merely philosophical unless the rights recognized by the Convention can be defended by a court of law. This is where the importance of the ratification of the CRPD by member and observer states comes into focus. By ratifying the treaty in 2008, Qatar committed itself to a number of social and legal obligations. However, implementation of the CRPD in Qatar is dependent on a number of factors including political willingness, the abilities of the CRPD's United Nations Follow-Up Committee, and the capacity to raise awareness among the public in Qatar. This paper looks into the traditional approaches taken towards persons with disabilities, the impact of the CRPD and the challenges faced by Qatar as it looks to implement the CRPD.

Miracle drug: Brazil approves never-tested cancer medicine.

Background Brazil recently approved synthetic phosphoetanolamine, a popularly dubbed 'cancer pill', a substance that has been shown to kill cancer cells in lab animal models but was not yet formally accessed in humans, and thus despite the existence of any evidence of its efficacy and safety. Methods The authors describe the recent decision of Brazil to aprove phosphoetanolamine in the context of growing 'judicialization' to promote access to medicines and thus reinforcing a growing sense of legal uncertainty. Results The approval of phosphoetanolamine despite the existence of any evidence of its efficacy and safety represents to the authors one of the saddest and surrealistic episodes in Brazil's recent public health history. Brazil's current economic crisis is fueling the 'judicialization' to promote access to medicines and thus reinforcing a growing sense of legal uncertainty in the context of rising economic constrains and a progressive failing state. The authors state that the Phosphoetanolamine's approval bill violates current legal prohibition of commercialisation of drugs without the Brazilian national drug regulatory agency's approval and thus may represent a potential menace to Brazil's pharmacogovernance and the country's governance to health technology assessment at the Brazilian national health systems. Conclusion Phosphoetanolamine's approval illustrates that the combination of flawed decision making, economic crisis and political interference may threaten weak governance mechanisms for drug regulation and health technology assessment and thus representing an extra burden in the sustainability of universal access-based national health systems.

Energy consumption to cool and heat experimental modules for the energy refurbishment of façades. Three case studies in Madrid

This article identifies the façade construction systems used on social housing in Madrid in the aftermath of the Spanish Civil War (1936–1939). A large percentage of the city’s present housing was built in that period, often under precarious circumstances, to accommodate rural migration to the city.The study described, inspired by the urgent need to improve the thermal performance of these enclosures to adapt them to today’s energy efficiency standards, consisted in monitoring innovative refurbishment solutions under controlled conditions.Three construction systems for façades were explored. One was the standard housing enclosure built in Madrid in the time frame mentioned, while the other two were solutions proposed for its energy refurbishment. The second system was a tile-based ventilated façade with national technical approval credentials and the third an ETIS (external thermal insulation system) with European technical approvals (ETA) credentials.The findings are analysed in terms of the energy consumption calculated for the three solutions. One of the most prominent conclusions of the study is that on south façades in climates where winter prevails (such as in Madrid), ETIS solutions are more effective than ventilated façades. In warmer climates and for other orientations, however, ventilated façades may be more efficient.

Composite dowels as shear connectors for composite beams – background to the German technical approval

AbstractComposite dowels are known as powerful shear connectors in steel‐concrete composite girders. They are being used more and more in practice, especially for prefabricated composite bridges. Compared with headed studs, they provide increased strength. They also exhibit good deformation capacity even in high‐strength concrete. Further, their use in steel sections without an upper flange is very simple. However, a lack of standards for composite dowels with the economic clothoid and puzzle shapes has led to hesitations regarding applications, which is often due to delays in the approval process. Hence, the aim of the recently finished German research project P804 funded by FOSTA, the Research Association for Steel Application, was to solve unanswered questions concerning these innovative shear connectors and to prepare a national technical approval available for any design office or construction company. This paper describes the technical rules derived for ultimate and fatigue limit states, the structural design principles and instructions for production and construction, and provides further background information.

Establishing a process for conducting cross‐jurisdictional record linkage in Australia

Objective:To describe the realities of conducting a cross‐jurisdictional data linkage project involving state and Australian Government‐based data collections to inform future national data linkage programs of work. Methods:We outline the processes involved in conducting a Proof of Concept data linkage project including the implementation of national data integration principles, data custodian and ethical approval requirements, and establishment of data flows. Results:The approval process involved nine approval and regulatory bodies and took more than two years. Data will be linked across 12 datasets involving three data linkage centres. A framework was established to allow data to flow between these centres while maintaining the separation principle that serves to protect the privacy of the individual. Conclusions:This will be the first project to link child immunisation records from an Australian Government dataset to other administrative health datasets for a population cohort covering 2 million births in two Australian states. Implications:Although the project experienced some delays, positive outcomes were realised, primarily the development of strong collaborations across key stakeholder groups including community engagement. We have identified several recommendations and enhancements to this now established framework to further streamline the process for data linkage studies involving Australian Government data.

Chemotherapy at First Diagnosis of Advanced Prostate Cancer – Revolution or Evolution? Findings from a British Uro-oncology Group UK Survey to Evaluate Oncologists' Views on First-line Docetaxel in Combination with Androgen Deprivation Therapy in Castrate-sensitive Metastatic and High-risk/Locally Advanced Prostate Cancer

AimsThere have been three randomised trials investigating docetaxel in combination with androgen deprivation therapy as first-line therapy for hormone-sensitive metastatic and locally advanced/high-risk prostate cancer. The largest of these studies, UK STAMPEDE trial, recently presented in June 2015. The aim of this survey was to evaluate if oncologists' practice has changed as a result of these studies, or if their practice is likely to change in different clinical settings in the future. Materials and methodsThe British Uro-oncology Group issued a semi-structured online questionnaire to its membership of 160 specialist urological oncologists practising in the UK. Links to the abstracts of GETUG-AFU-15, E3805 CHAARTED and STAMPEDE were attached with the survey for respondents to review before completing the survey. ResultsIn total, 111 participants completed the survey; 87% stated that STAMPEDE will influence their clinical practice in the future. Almost all (96%) would offer docetaxel with androgen deprivation therapy to men presenting with high volume metastatic prostate cancer. Fewer oncologists would offer this treatment to men with low volume metastatic prostate cancer, locally advanced or relapsed disease. Various patient- and disease-related factors were considered in decision making, as well as resource implications. ConclusionsThis survey reports oncologists' attitudes towards a major change in practice in the standard of care for men with newly diagnosed advanced prostate cancer in the UK. The survey highlighted the complexities surrounding the clinical implementation of the data from these studies, including changes in referral pathways, with the early involvement of oncologists in such patients' care, increases in workloads for oncologists and chemotherapy units and the need for national approval for re-imbursement of these treatments.

Flexible Plug Joint System with New Material

Up to now the common material used for flexible plug joints of bridges has been based on bituminous mixtures consisting of aggregates and elastomeric-modified binders. All existing national regulations and also the European Guideline for Expansion Joints ETAG 032 are restricting flexible plug joints to these traditional bituminous mixtures. All existing asphaltic mixtures are susceptible for plastic deformations at higher temperatures including rutting whereas they cause significant reaction forces at low temperatures. These properties limit the application of the traditional joints to areas with moderate climate. In practice asphaltic plug expansion joints also often fail in the intersection between adjacent pavement and joint, causing cracks and leakages. The new expansion joint system shows essential improvements in the intersection pavement/joint by mechanical means and uses a new material based on polyurethane, which does not show negative temperature affine properties and can be processed in cold condition. The new flexible plug joint system also enables new applications, both for a wider climatic range and more complicated geometries. Furthermore the new flexible plug joint allows for larger movements up to more than 100mm and addresses a longer design working life. As the new design is not covered by existing standards and verification methods in the first phase a comprehensive research had to executed after consultation with leading European experts from Germany, Switzerland and Austria. The paper covers reports on material and system tests executed during national and European approval procedures at several European testing institutes and shows examples of installation.

Fibre Reinforced Polymers (FRP) as Reinforcement for Concrete According to German Approvals

This article demonstrates the possibility of the application of joint principles to develop test programs for national approval or European Technical Assessments of FRP reinforcement for concrete. The limits of different systems are shown, which until now have been approved in Germany.

Multiple physical signs detection and decision support system for hospitalized older adults

Health monitoring systems have rapidly evolved during the past two decades and have the potential to change the way healthcare is currently delivered. Smart monitoring systems automate patient monitoring tasks and thereby improve patient workflow management. Moreover, expert systems have the potential to assist clinicians and improve their performance by accurately executing repetitive tasks, to which humans are ill-suited. Clinicians working in hospital wards are responsible for conducting a multitude of tasks which require constant vigilance, and thus the need for a smart decision support system has arisen. In particular, wireless patient monitoring systems are emerging as a low cost, reliable and accurate means of healthcare delivery.Vital signs monitoring systems are rapidly becoming part of today’s healthcare delivery. The paradigm has shifted from traditional and manual recording to computer-based electronic records and, further, to handheld devices as versatile and innovative healthcare monitoring systems. The current study focuses on interpreting multiple physical signs and early warning for hospitalized older adults so that severe consequences can be minimized. Data from a total of 30 patients have been collated in New Zealand hospitals under local and national ethics approvals. The system records blood pressure, heart rate (pulse), oxygen saturation (SpO2), ear temperature and blood glucose levels from hospitalized patients and transfers this information to a web-based software application for remote monitoring and further interpretation. Ultimately, this system is aimed to achieve a high level of agreement with clinicians’ interpretation when assessing specific physical signs such as bradycardia, tachycardia, hypertension, hypotension, hypoxaemia, fever and hypothermia to generate early warnings. The performance of the vital signs interpretation system was validated through off-line as well as real-time tests with a high level of agreement between the system and physician.

Integrated vital signs monitoring system using ubiquitous devices: Multiple physical signs detection and decision support for hospitalized older adults.

Vital signs monitoring systems are rapidly becoming the core of today's healthcare deliveries. The paradigm has shifted from traditional and manual recording to computer based electronic records and further to handheld devices as versatile and innovative healthcare monitoring systems. Interpretation of vital signs to early detect multiple physical signs using a multifactorial and holistic approach is presented. A total of 30 patient data have been collected under local and national ethics approvals in New Zealand Hospitals. Ultimately, this system achieved a high level of agreement with clinicians' interpretation when assessing specific physical signs such as bradycardia, tachycardia, hypertension, hypotension, hypoxaemia, fever and hypothermia. The proposed vital signs interpretation system was validated through off-line as well as real-time tests with a high level of agreement between the system and the physician. The system achieved an accuracy of 95.83%, sensitivity of 100%, specificity of 93.15%, and predictability of 90.38% in compare with a clinician assessment for tachycardia, hypertension, hypotension, hypoxaemia and hypothermia.

Financing Decisions and Product Introductions of Private and Publicly Traded Firms

We exploit Medicare national coverage reimbursement approvals of medical devices as a quasinatural experiment to investigate how private and publicly traded firm financing decisions and product introductions respond to exogenous changes in investment opportunities. We find that publicly traded companies increase their external financing, and their subsequent product

How Reliable Is National Approval of University Degrees?

International Higher Education (IHE) publishes insightful, informed, and high-quality commentary and analysis on trends and issues of importance to higher education systems, institutions, and stakeholders around the world.

O planejamento educacional na pós-graduação em educação no Brasil

Levantamento das informações fornecidas pelos programas de pós-graduação em educação no período 2000-2009, disponíveis no portal da Coordenação de Aperfeiçoamento de Pessoal de Nível Superior, revela a progressiva substituição dos estudos sobre planejamento educacional por estudos sobre gestão e avaliação. Confronta-se esse "esvaziamento" com a "fertilidade" dos anos 1970/1980, analisando fontes utilizadas e conteúdos trabalhados nos mestrados em educação da PUC-Rio e da Fundação Getulio Vargas. Nas considerações fi nais, afi rma-se que esse "esvaziamento" foi simultâneo à desagregação do sistema de planejamento brasileiro, ocorrida nos anos de 1990, e sugere retomar aqueles estudos, a partir das últimas Conferências Nacionais de Educação e das dificuldades de aprovação pelo Congresso Nacional dos planos nacionais de educação por elas propostos.

European punching design provisions for double-headed studs

Double-headed studs are used as punching shear reinforcement in reinforced or prestressed slabs and footings. Owing to an improved anchoring behaviour, double-headed studs have a higher load capacity than stirrups. Double-headed studs are quick to install and are therefore more cost-effective than stirrups. Previously in Europe, national technical approvals specified the design of double-headed studs. Since the end of 2012, European technical approvals have been available. All approvals are based on the same design method, which is used in combination with BS EN 1992-1-1. It is necessary to distinguish between punching shear failure in slabs and foundations with and without shear reinforcement. In slabs and foundations with shear reinforcement, a failure can occur at maximum load level, in and outside the shear-reinforced zone. The European technical approvals provide design equations for all types of failure modes. To quantify the safety level of the design provisions for slabs, footings, and ground slabs with and without shear reinforcement, test evaluations based on a reliable data bank are shown. The paper also provides useful background information and additional design recommendations for applications, which are not covered by the design provisions of the European technical approvals.

G223(P) A Novel Neonatal Hospital Record System to improve note keeping for infants admitted to a neonatal unit in a low resource country

AimTraining and knowledge of specialist neonatal care is frequently limited in low resource countries. We aimed to assess if the introduction of a standardised medical record could improve documentation, assisting...

Regulatorische Probleme der Energiewende: Smart Meters – Anforderungen des Messwesens und des Datenschutzes

Neither the Metrology Law nor the Data Protection Law currently prohibit or prevent the use of smart meters. A new issue challenging us, however, is the fact that a wide range of measuring instruments is potentially affected and that their use may be stipulated and thus become mandatory. In the article, smart meters are examined with particular reference to legal metrology and data protection. Both the Metrology Law and the Data Protection Law are based on general principles or axioms. Whereas they apply to all processing of personal data, in metrology they only apply directly to legally recorded measuring instruments. Legal metrology is shaped by detailed provisions at various regulatory levels. Provisions of this type are only encountered occasionally in data protection (in Germany, for example). In order to regulate new technologies on a scale such as that for smart meters, a consistent legal framework is called for. If – as in the case of smart meters – the Energy Law, Metrology Law and Data Protection Law are not sufficiently harmonised, problems could arise. In particular, European metrology legislation has yet to come up with a convincing regulation in this area. In an extreme case, a smart meter is subject to several national or supranational approval procedures. Procedures of this kind should be coordinated to the greatest possible extent and conducted unbureaucratically. Complexity is increasing: ever more legislative fields must be coordinated, ever more players are appearing in the wake of market liberalisation, ever more legal systems interact directly and indirectly, and ultimately a functional smart grid presupposes that there is smooth interplay between all components. This complexity will be coped with in the medium term but scarcely in the initial phase.