Bluh, Pamela; And Others
1996-01-01
This special section on EDI (Electronic Data Interchange) in libraries includes eight articles that discuss experiences in libraries in the United Kingdom, EDI and the acquisitions process in Europe, a Canadian viewpoint, the ILS (Integrated Library Systems) vendor and EDI, public libraries, and EDI in the information services industry. (LRW)
Internal control in an EDI environment.
Bae, Dal Hyeoung
1991-01-01
Approved for public release; distribution in unlimited. Electronic Data Interchange(EDI) is the electronic transmission of standard business documents in machine-readable format between parent companies and respective trading partners. As the use of EDI has grown, there have been the associated risks due to an uncontrolled environment. Accordingly, the necessity for effective internal controls in an EDI environment is on the rise. This thesis evaluates and analyzes the feasi...
Human coronavirus NL63, France
Vabret, Astrid; Mourez, Thomas; Dina, Julia; van der Hoek, Lia; Gouarin, Stéphanie; Petitjean, Joëlle; Brouard, Jacques; Freymuth, François
2005-01-01
The human coronavirus NL63 (HCoV-NL63) was first identified in The Netherlands, and its circulation in France has not been investigated. We studied HCoV-NL63 infection in hospitalized children diagnosed with respiratory tract infections. From November 2002 to April 2003, we evaluated 300 respiratory
DEFF Research Database (Denmark)
Falch, Morten
1998-01-01
Introduction of EDI in the public administration is apriority for the Danish Government. EDI is both seen as a catlyst for development towards an information society ans as a means for more efficient use of scarce resources. EDI in the banking sector and the retail sector is reviewed, drivers...
Põdra, Priit, 1963-
2000-01-01
Projekt EDI töötab välja programmisüsteemi rahvusvaheliste kaubavedude korraldamiseks, dokumentide vormistamiseks ja firmade arvutiprogrammide koostöö korraldamiseks. Projekti tutvustab AS-i EDI VEKTOR juhatuse esimees Priit Põdra
Ability of EDI-2 and EDI-3 to correctly identify patients and subjects at risk for eating disorders.
Segura-García, Cristina; Aloi, Matteo; Rania, Marianna; Ciambrone, Paola; Palmieri, Antonella; Pugliese, Valentina; Ruiz Moruno, Antonio José; De Fazio, Pasquale
2015-12-01
The prevention and early recognition of eating disorders (EDs) are important topics in public health. This study aims to compare the efficacy of the Eating Disorder Inventory 2 (EDI-2) with the new version, EDI-3 in recognising patients and identifying subjects at risk for EDs. The EDI-2 and EDI-3 were administered to 92 female patients with ED and 265 females from a population at risk for EDs. Experienced psychiatrists in this field held blind interviews with participants by means of the SCID-I to determine the diagnosis. According to the cut-offs suggested by the authors, the EDI-3 correctly identified nearly all of the ED patients (99%), while the EDI-2 divulged less than half (48%). Both versions of the test showed comparable capability to identify participants at risk for EDs but the EDI-3 seemed slightly more reliable than the EDI-2. The EDI-2 remains a valid and very specific test. However, the new EDI-3 seems to be experimentally superior, because it typifies nearly all patients across the ED span, including those with Binge Eating Disorder and Eating Disorder Not Otherwise Specified. In addition, it appears to be more reliable. Copyright © 2015 Elsevier Ltd. All rights reserved.
Introduction of EDI in the public sector
DEFF Research Database (Denmark)
Falch, Morten
1997-01-01
Reviews the status of EDI in the sectors of health, public transport and taxation and public administration. The impact of this on the diffusion of EDI in other sectors is analysed.......Reviews the status of EDI in the sectors of health, public transport and taxation and public administration. The impact of this on the diffusion of EDI in other sectors is analysed....
The new Exponential Directional Iterative (EDI) 3-D Sn scheme for parallel adaptive differencing
International Nuclear Information System (INIS)
Sjoden, G.E.
2005-01-01
The new Exponential Directional Iterative (EDI) discrete ordinates (Sn) scheme for 3-D Cartesian Coordinates is presented. The EDI scheme is a logical extension of the positive, efficient Exponential Directional Weighted (EDW) Sn scheme currently used as the third level of the adaptive spatial differencing algorithm in the PENTRAN parallel discrete ordinates solver. Here, the derivation and advantages of the EDI scheme are presented; EDI uses EDW-rendered exponential coefficients as initial starting values to begin a fixed point iteration of the exponential coefficients. One issue that required evaluation was an iterative cutoff criterion to prevent the application of an unstable fixed point iteration; although this was needed in some cases, it was readily treated with a default to EDW. Iterative refinement of the exponential coefficients in EDI typically converged in fewer than four fixed point iterations. Moreover, EDI yielded more accurate angular fluxes compared to the other schemes tested, particularly in streaming conditions. Overall, it was found that the EDI scheme was up to an order of magnitude more accurate than the EDW scheme on a given mesh interval in streaming cases, and is potentially a good candidate as a fourth-level differencing scheme in the PENTRAN adaptive differencing sequence. The 3-D Cartesian computational cost of EDI was only about 20% more than the EDW scheme, and about 40% more than Diamond Zero (DZ). More evaluation and testing are required to determine suitable upgrade metrics for EDI to be fully integrated into the current adaptive spatial differencing sequence in PENTRAN. (author)
Efficient Processing Of Voluminous EDI Documents
Risse, T.; Wombacher, Andreas; Aberer, K.
Business data is frequently exchanged between heterogeneous information systems using standard EDI formats like EDIFACT, X12 and in the future also XML/EDI. For inhouse use, data represented in these formats must be converted to inhouse data formats by message converters. With the growing usage of
EDIS Investigation Filing Information
US International Trade Commission — This dataset contains investigation, document and attachment metadata from the USITC's Electronic Document Information System (EDIS), as well as access to attached...
Rusk, Harriet J.
1991-01-01
Considered are standardization efforts of the American National Standards Institute's Accredited Standards Committee X12 concerned with electronic data interchange (EDI). These efforts will effect dentistry first in the transmission of academic records, and then in communications between dental offices and businesses, including major insurance…
Development of the Electron Drift Instrument (EDI) for Cluster
Quinn, Jack; Christensen, John L. (Technical Monitor)
2001-01-01
The Electron Drift Instrument (EDI) is a new technique for measuring electric fields in space by detecting the effect on weak beams of test electrons. This U.S. portions of the technique, flight hardware, and flight software were developed for the Cluster mission under this contract. Dr. Goetz Paschmann of the Max Planck Institute in Garching, Germany, was the Principle Investigator for Cluster EDI. Hardware for Cluster was developed in the U.S. at the University of New Hampshire, Lockheed Palo Alto Research Laboratory, and University of California, San Diego. The Cluster satellites carrying the original EDI instruments were lost in the catastrophic launch failure of first flight of the Arianne-V rocket in 1996. Following that loss, NASA and ESA approved a rebuild of the Cluster mission, for which all four satellites were successfully launched in the Summer of 2000. Limited operations of EDI were also obtained on the Equator-S satellite, which was launched in December, 1997. A satellite failure caused a loss of the Equator-S mission after only 5 months, but these operations were extremely valuable in learning about the characteristics and operations of the complex EDI instrument. The Cluster mission, satellites, and instruments underwent an extensive on-orbit commissioning phase in the Fall of 2000, carrying over through January 2001. During this period all elements of the instruments were checked and careful measurements of inter-experiments interferences were made. EDI is currently working exceptionally well in orbit. Initial results verify that all aspects of the instrument are working as planned, and returning highly valuable scientific information. The first two papers describing EDI on-orbit results have been submitted for publication in April, 2001. The principles of the EDI technique, and its implementation on Cluster are described in two papers by Paschmann et al., attached as Appendices A and B. The EDI presentation at the formal Cluster Commissioning
Business Process Redesign Using EDI: the BHP steel experience
Directory of Open Access Journals (Sweden)
Paula Swatman
1994-05-01
Full Text Available EDI should not be seen as a competitive weapon - it does not offer a sustainable competitive advantage to its users as did the earlier inter-organisational systems (such as the various airline reservation systems. Instead EDI provides a standardised infrastructure upon which an adopting organisation can reengineer its business processes and thus confers a long-term, strategic and comparative advantage upon such an adopter. The potential for sustained competitive advantage to be derived from EDI arises from its integration with the organisational structure of its implementor, depending upon the implementing organisation's ability to redesign its business processes appropriately. This paper examines the case of (arguably the most sophisticated EDI-using company in Australia, BHP Steel, demonstrating the advantages obtainable by an organisation using EDI as a foundation for its reengineered organisational structure and business processes and concludes that: • there are real benefits to be obtained from an inter organisational electronic trading strategy founded on EDI as the enabling mechanism - benefits which are considerably more extensive than EDI's comparatively simple technical nature would appear to offer; • organisational gateways utilising an Application Generic approach to system integration and isolating the communications issue by insisting on the use of international data communications standards do offer a realistic and successful solution to the problem of internal and external trade for large and sophisticated organisations; • the majority of these achievements would have been either unlikely or totally impossible without BHP Steel's commitment to organisation-wide Business Process Redesign.
Electronic Data Interchange (EDI) for Libraries and Publishers.
Santosuosso, Joe
1992-01-01
Defines electronic data interchange (EDI) as the exchange of data between computer systems without human intervention or interpretation. Standards are discussed; and the implementation of EDI in libraries and the serials publishing community in the areas of orders and acquisitions, claims, and invoice processing is described. (LRW)
The EDIE method – towards an approach to collaboration-based persuasive design
DEFF Research Database (Denmark)
Hansen, Sandra Burri Gram
2016-01-01
This paper presents the initial steps towards a collaboration-based method for persuasive design – the EDIE method (Explore, Design, Implement, Evaluate). The method is inspired by Design-Based Research, but developed to combine different design approaches that have dominated the persuasive...... technology field over the past decade. The rhetorical notion of Kairos is considered a key element in the EDIE method, resulting in a distinct focus on participatory design and constructive ethics. The method is explained through a practical example of developing persuasive learning designs in collaboration...
The ISO Edi Conceptual Model Activity and Its Relationship to OSI.
Fincher, Judith A.
1990-01-01
The edi conceptual model is being developed to define common structures, services, and processes that syntax-specific standards like X12 and EDIFACT could adopt. Open Systems Interconnection (OSI) is of interest to edi because of its potential to help enable global interoperability across Electronic Data Interchange (EDI) functional groups. A…
Binary trading relations and the limits of EDI standards
DEFF Research Database (Denmark)
Damsgaard, Jan; Truex, D.
2000-01-01
This paper provides a critical examination of electronic data interchange (EDI) standards and their application in different types of trading relationships. It argues that EDI standards are not directly comparable to more stable sets of technical standards in that they are dynamically tested...... and negotiated in use with each trading exchange. It takes the position that EDI standards are an emergent language form and must mean different things at the institutional and local levels. Using the lens of emergent linguistic analysis it shows how the institutional and local levels must always be distinct...... and yet can coexist. EDI standards can never represent the creation of an 'Esperanto of institutional communication'. Instead we believe that standards must be developed such that they support and accommodate general basic grammatical forms that can be customised to individual needs. The analysis...
Ângela Tonietto; Bruno Telles; Charles A. Andrade; Claudemir R. Dias Filho; Juliano A. Gomes
2016-01-01
Após cinco translações em torno da estrela do Sistema Solar e nove edições publicadas, a Revista Brasileira de Criminalística entrega hoje o terceiro número do seu quinto volume, completando assim cinco anos ininterruptos de publicações com sua décima edição.
EDI and the Technical Communicator.
Eiler, Mary Ann
1994-01-01
Assesses the role of technical communicators in electronic data interchange (EDI). Argues that, as experts in information design, human factors, instructional theory, and professional writing, technical communicators should be advocates of standard documentation protocols and should rethink the traditional concepts of "document" to…
UltiMatch-NL: a Web service matchmaker based on multiple semantic filters.
Mohebbi, Keyvan; Ibrahim, Suhaimi; Zamani, Mazdak; Khezrian, Mojtaba
2014-01-01
In this paper, a Semantic Web service matchmaker called UltiMatch-NL is presented. UltiMatch-NL applies two filters namely Signature-based and Description-based on different abstraction levels of a service profile to achieve more accurate results. More specifically, the proposed filters rely on semantic knowledge to extract the similarity between a given pair of service descriptions. Thus it is a further step towards fully automated Web service discovery via making this process more semantic-aware. In addition, a new technique is proposed to weight and combine the results of different filters of UltiMatch-NL, automatically. Moreover, an innovative approach is introduced to predict the relevance of requests and Web services and eliminate the need for setting a threshold value of similarity. In order to evaluate UltiMatch-NL, the repository of OWLS-TC is used. The performance evaluation based on standard measures from the information retrieval field shows that semantic matching of OWL-S services can be significantly improved by incorporating designed matching filters.
UltiMatch-NL: A Web Service Matchmaker Based on Multiple Semantic Filters
Mohebbi, Keyvan; Ibrahim, Suhaimi; Zamani, Mazdak; Khezrian, Mojtaba
2014-01-01
In this paper, a Semantic Web service matchmaker called UltiMatch-NL is presented. UltiMatch-NL applies two filters namely Signature-based and Description-based on different abstraction levels of a service profile to achieve more accurate results. More specifically, the proposed filters rely on semantic knowledge to extract the similarity between a given pair of service descriptions. Thus it is a further step towards fully automated Web service discovery via making this process more semantic-aware. In addition, a new technique is proposed to weight and combine the results of different filters of UltiMatch-NL, automatically. Moreover, an innovative approach is introduced to predict the relevance of requests and Web services and eliminate the need for setting a threshold value of similarity. In order to evaluate UltiMatch-NL, the repository of OWLS-TC is used. The performance evaluation based on standard measures from the information retrieval field shows that semantic matching of OWL-S services can be significantly improved by incorporating designed matching filters. PMID:25157872
Scheltens, Nienke M E; Kuyper, Ingrid S; Boellaard, Ronald; Barkhof, Frederik; Teunissen, Charlotte E; Broersen, Laus M; Lansbergen, Marieke M; van der Flier, Wiesje M; van Berckel, Bart N M; Scheltens, Philip
2016-11-01
Alzheimer's disease is associated with early synaptic loss. Specific nutrients are known to be rate limiting for synapse formation. Studies have shown that administering specific nutrients may improve memory function, possibly by increasing synapse formation. This Dutch study explores the Effect of a specific Nutritional Intervention on cerebral Glucose Metabolism in early Alzheimer's disease (NL-ENIGMA, Dutch Trial Register NTR4718, http://www.trialregister.nl/trialreg/admin/rctview.asp?TC=4718). The NL-ENIGMA study is designed to test whether the specific multinutrient combination Fortasyn Connect present in the medical food Souvenaid influences cerebral glucose metabolism as a marker for improved synapse function. This study is a double-blind, randomized controlled parallel-group single-center trial. Forty drug-naive patients with mild cognitive impairment or mild dementia with evidence of amyloid deposition are 1:1 randomized to receive either the multinutrient combination or placebo once daily. Main exploratory outcome parameters include absolute quantitative positron emission tomography with 18 F-fluorodeoxyglucose (including arterial sampling) and standard uptake value ratios normalized for the cerebellum or pons after 24 weeks. We expect the NL-ENIGMA study to provide further insight in the potential of this multinutrient combination to improve synapse function.
Pro EDI in BizTalk Server 2006 R2 electronic document interchange solutions
Beckner, Mark
2008-01-01
As business becomes more dependent on working with partners, suppliers, and other organizations in a streamlined way, Electronic Data Interchange (EDI) is one of the next big waves in connected systems. Microsoft BizTalk Server 2006 R2 offers an efficient, integrated way to deploy EDI solutions, and with the help of this book, readers will see how EDI can be used in their business and how best to get it set up with BizTalk. This book offers insights into the brand-new Biztalk 2006 R2--based EDI functionality, including the far greater flexibility in handling interchange. It gives advice coveri
[A German version of the Eating Disorder Inventory EDI-2].
Thiel, A; Jacobi, C; Horstmann, S; Paul, T; Nutzinger, D O; Schüssler, G
1997-01-01
The paper presents a German version of the second revised edition of the Eating Disorder Inventory EDI-2 (Garner 1991). The EDI-2 is a self-rating inventory (self-report measure) with 91 items and 11 subscales designed for the assessment of attitudinal and behavioural dimensions relevant to anorexia and bulimia nervosa. It consists of the eight original subscales: drive for thinness, bulimia, body dissatisfaction, ineffectiveness, perfectionism, interpersonal distrust, interoception and maturity fears, and the three new subscales: asceticism, impulse regulation and social insecurity. The German EDI-2 was given to 71 patients with anorexia or bulimia nervosa, 30 patients with binge eating disorder, a control group of 186 women and a further control group of 102 men. In comparison to the female control group, patient groups showed significantly elevated means on all subscales. Item analysis revealed sufficient internal consistencies for all subscales except subscale 9 (asceticism) with Cronbachs alpha ranging from 0.58 to 0.90. Twelve of the 91 items showed poor item total scale correlations below 0.40. Factor analysis supported a six-factor-structure. Hence, the reliability and validity of the three new subscales was confirmed only partially. The use of the EDI-2 in therapy research and clinical practice is critically discussed.
Ediţii ale Clasificării Zecimale Dewey
Directory of Open Access Journals (Sweden)
Zenovia Niculescu
2009-01-01
Full Text Available Studiul abordează evoluţia ediţiilor C.Z.D. din perspective actualizării terminologiei, realocărilor şi extinderii structurii principale şi auxiliare a limbajului de indexare Dewey. Analiza comparativă a ediţiilor C.Z.D. reflectă amplificarea şi eficientizarea schemei Dewey din punct de vedere al îmbunătăţirii ofertei informaţionale, prin indici de bază revizuiţi şi dezvoltaţi, precum şi a valorizării notaţiilor auxiliare.
Park, Jong-Hyeok; Kim, Ki-Beom; Chang, Heon-Young
2014-08-01
Time series of drought indices has been considered mostly in view of temporal and spatial distributions of a drought index so far. Here we investigate the statistical properties of a daily Effective Drought Index (EDI) itself for Seoul, Busan, Daegu, Mokpo for the period of 100 years from 1913 to 2012. We have found that both in dry and wet seasons the distribution of EDI as a function of EDI follows the Gaussian function. In dry season the shape of the Gaussian function is characteristically broader than that in wet seasons. The total number of drought days during the period we have analyzed is related both to the mean value and more importantly to the standard deviation. We have also found that according to the distribution of the number of occasions where the EDI values of several consecutive days are all less than a threshold, the distribution follows the exponential distribution. The slope of the best fit becomes steeper not only as the critical EDI value becomes more negative but also as the number of consecutive days increases. The slope of the exponential distribution becomes steeper as the number of the city in which EDI is simultaneously less than a critical EDI in a row increases. Finally, we conclude by pointing out implications of our findings.
Electronic Transcripts--EDI in Academic Administration.
Carson, E. W.
1991-01-01
Newly developed electronic data interchange (EDI) standards for exchanging academic records between colleges and universities are explained. It is argued that implementation of the new standards in college registrar and admissions offices can improve speed, costs, and accuracy and provide a prototype for a variety of campus business applications.…
Seroconversion to HCoV-NL63 in Rhesus Macaques
Directory of Open Access Journals (Sweden)
Lia van der Hoek
2009-10-01
Full Text Available HCoV-NL63 is a recently identified respiratory virus. Its pathogenesis has not been fully unraveled because an animal model is currently lacking. Here we examined whether rhesus macaques encounter HCoV-NL63 infections during life, by examining the levels of antibodies to HCoV-NL63 in time. The animals were followed for 7 up till 19 years, and in three animals we observed a steep rise in antibodies during follow up, indicative of a natural infection with HCoV-NL63.
An arithmetic transference proof of a relative Szemer\\'edi theorem
Zhao, Yufei
2013-01-01
Recently Conlon, Fox, and the author gave a new proof of a relative Szemer\\'edi theorem, which was the main novel ingredient in the proof of the celebrated Green-Tao theorem that the primes contain arbitrarily long arithmetic progressions. Roughly speaking, a relative Szemer\\'edi theorem says that if S is a set of integers satisfying certain conditions, and A is a subset of S with positive relative density, then A contains long arithmetic progressions, and our recent results show that S only ...
Magnetic field gradients inferred from multi-point measurements of Cluster FGM and EDI
Teubenbacher, Robert; Nakamura, Rumi; Giner, Lukas; Plaschke, Ferdinand; Baumjohann, Wolfgang; Magnes, Werner; Eichelberger, Hans; Steller, Manfred; Torbert, Roy
2013-04-01
We use Cluster data from fluxgate magnetometer (FGM) and electron drift instrument (EDI) to determine the magnetic field gradients in the near-Earth magnetotail. Here we use the magnetic field data from FGM measurements as well as the gyro-time data of electrons determined from the time of flight measurements of EDI. The results are compared with the values estimated from empirical magnetic field models for different magnetospheric conditions. We also estimated the spin axis offset of FGM based on comparison between EDI and FGM data and discuss the possible effect in determining the current sheet characteristics.
International Nuclear Information System (INIS)
Safronova, U. I.; Safronova, A. S.
2011-01-01
Wavelengths, transition rates, and line strengths are calculated for the multipole (E1, M1, E2, M2, E3, and M3) transitions between the excited [Cd]4f 13 5p 6 nl, [Cd]4f 14 5p 5 nl configurations and the ground [Cd]4f 14 5p 6 state in Er-like W 6+ ion ([Cd]=[Kr]4d 10 5s 2 ). In particular, the relativistic many-body perturbation theory (RMBPT), including the Breit interaction, is used to evaluate energies and transition rates for multipole transitions in this hole-particle system. This method is based on the relativistic many-body perturbation theory that agrees with multiconfiguration Dirac-Fock (MCDF) calculations in lowest order, and includes all second-order correlation corrections and corrections from negative-energy states. The calculations start from a [Cd]4f 14 5p 6 Dirac-Fock (DF) potential. First-order perturbation theory is used to obtain intermediate-coupling coefficients, and second-order RMBPT is used to determine the multipole matrix elements needed for calculations of other atomic properties such as line strengths and transition rates. In addition, core multipole polarizability is evaluated in random-phase and DF approximations. The comparison with available data is demonstrated.
Energy Technology Data Exchange (ETDEWEB)
NONE
1994-08-15
This report documents a test transfer of three Air Force technical procurement bid sets to one large and twelve small businesses, using the Department of Defense (DoD) Continuous Acquisition and Life-cycle Support (CALS) and ANSI ASC X12 Electronic Data Interchange (EDI) standards. The main goal of the test was to evaluate the effectiveness of using CALS technical data within the context of the DoD`s EDI-based standard approach to electronic commerce in procurement, with particular emphasis on receipt and use of the data by small contractors. Air Force procurement data was provided by the Sacramento Air Logistics Center at McClellan Air Force Base; the manufacturing participants were selected from among McClellan`s ``Blue Ribbon`` contractors, located throughout the US. The test was sponsored by the Air Force CALS Test Network, headquartered at Wright-Patterson Air Force Base. The test successfully demonstrated the technical feasibility of including CALS MIL-R-28002 (Raster) engineering data in an EDI Specification/Technical Information transaction set (ANSI ASC X12 841) when issuing electronic requests for quotation to small businesses. In many cases, the data was complete enough for the contractor participant to feel comfortable generating a quote. Lessons learned from the test are being fed back to the CALS and EDI standards organizations, and to future implementors of CALS-EDI based acquisition or contracting systems, which require the transfer of technical information, such as engineering data, manufacturing process data, quality test data, and other product or process data, in the form of a CALS or other digital datafile.
Salavati, M; Waninge, A; Rameckers, E A A; de Blécourt, A C E; Krijnen, W P; Steenbergen, B; van der Schans, C P
2015-02-01
The aims of this study were to adapt the Paediatric Evaluation of Disability Inventory, Dutch version (PEDI-NL) for children with cerebral visual impairment (CVI) and cerebral palsy (CP) and determine test-retest and inter-respondent reliability. The Delphi method was used to gain consensus among twenty-one health experts familiar with CVI. Test-retest and inter-respondent reliability were assessed for parents and caregivers of 75 children (aged 50-144 months) with CP and CVI. The percentage identical scores of item scores were computed, as well as the interclass coefficients (ICC) and Cronbach's alphas of scale scores over the domains self-care, mobility, and social function. All experts agreed on the adaptation of the PEDI-NL for children with CVI. On item score, for the Functional Skills scale, mean percentage identical scores variations for test-retest reliability were 73-79 with Caregiver Assistance scale 73-81, and for inter-respondent reliability 21-76 with Caregiver Assistance scale 40-43. For all scales over all domains ICCs exceeded 0.87. For the domains self-care, mobility, and social function, the Functional Skills scale and the Caregiver Assistance scale have Cronbach's alpha above 0.88. The adapted PEDI-NL for children with CP and CVI is reliable and comparable to the original PEDI-NL. Copyright © 2014 Elsevier Ltd. All rights reserved.
Sam Kurokawa; Seiji Manabe
2002-01-01
This paper examines determinants of EDI adoption and integration in the US and Japanese automobile suppliers. The paper constructs several hypotheses based on the transaction-cost and resource- dependence approaches, and tests these hypotheses by using data from the automobile suppliers. Our study shows: (1) the resource-dependence approach seemed more effective in explaining EDI adoption, while the transaction-cost approach seemed more effective in explaining EDI integration; (2) the transac...
DOD Electronic Commerce (EC)/Electronic Data Interchange (EDI) in contracting report
1993-12-01
Use of Electronic Commerce (EC)/Electronic Data Interchange (EDI) to support Department of Defense (DoD) procurement processes has been under consideration for some time. A 1988 Deputy Secretary of Defense memo calls for maximum use of EDI, based on 10 years of DoD EDI investigation and experiments. In 1990, Defense Management Review Decision 941 stated, 'The strategic goal of DoD's current efforts is to provide the department with the capability to initiate, conduct, and maintain its external business related transactions and internal logistics, contracting, and financial activities without requiring the use of hard copy media.' The EC in Contracting PAT membership reflected a broad cross section of Military Services and Defense Agencies working on a full-time basis for 60 days. The diversity of the EC in Contracting PAT ensured that the needs and concerns of all DoD components were addressed during the creation of the report. The resultant plan, therefore, represents a comprehensive approach for implementing EC throughout the DoD.
Salavati, Masoud; Waninge, Aly; Rameckers, E.A.A.; de Blécourt, A.C.E.; Krijnen, Wim; Steenbergen, B.; van der Schans, Cees
Purpose The aims of this study were to adapt the Paediatric Evaluation of Disability Inventory, Dutch version (PEDI-NL) for children with cerebral visual impairment (CVI) and cerebral palsy (CP) and determine test–retest and inter-respondent reliability. Method The Delphi method was used to gain
Salavati, M.; Waninge, A.; Rameckers, E. A. A.; de Blecourt, A. C. E.; Krijnen, W. P.; Steenbergen, B.; van der Schans, C. P.
Purpose: The aims of this study were to adapt the Paediatric Evaluation of Disability Inventory, Dutch version (PEDI-NL) for children with cerebral visual impairment (CVI) and cerebral palsy (CP) and determine test-retest and inter-respondent reliability. Method: The Delphi method was used to gain
Mousavi, Amin; Krishnan, Vijaya
2016-01-01
The Early Development Instrument (EDI) is a widely used teacher rating tool to assess kindergartners' developmental outcomes in Canada and a number of other countries. This paper examines the measurement invariance of EDI domains across ESL status and gender by means of multi-group confirmatory factor analysis. The results suggest evidence of…
JST Thesaurus Headwords and Synonyms: EDI [MeCab user dictionary for science technology term[Archive
Lifescience Database Archive (English)
Full Text Available MeCab user dictionary for science technology term EDI 名詞 一般 * * * * EDI【情報交換】 EDI イーディーアイ Thesaurus2015 200906091295492920 C EG01 UNKNOWN_1 EDI
Numerical simulation of the electrodeionization (EDI) process accounting for water dissociation
International Nuclear Information System (INIS)
Lu Jun; Wang Yuxin; Zhu Jia
2010-01-01
The electrodeionization process (EDI) is usually operated at overlimiting current density, and is thus characterized by water dissociation and concentration polarization. We attempt to study the useful and harmful effects of water dissociation on the EDI process. A numerical steady state model was established to simulate the process of EDI, accounting for the effects of water dissociation. The differences in concentration polarization of membranes were investigated to study the effects of water dissociation on cation and anion membranes. Protons produced by water dissociation caused the resin to transform into the H-form. The H-form resin, which has high conductivity and high transport number, depletes protons in the interstitial solution. This explains the experimentally detected phenomenon that at high current densities, the pH value of the effluency of the dilute compartment (DC) stops decreasing when current increases. We suggest that the useful role of water dissociation in EDI is due to the H-form resin bringing more salt cations of the interstitial solution into the resin phase, thus producing a high conductivity channel for the electro-migration of the salt cations. This mechanism avoids the decrease in salt ion conductivity brought about by concentration polarization. The disadvantageous effect of concentration polarization on the transportation of salt ions in interstitial solution is thus lessened. An intermediate point between the useful and harmful effects of water dissociation was determined by the dependence of current efficiency and removal rate for both cations and anions as a function of current density.
EdiPy: a resource to simulate the evolution of plant mitochondrial genes under the RNA editing.
Picardi, Ernesto; Quagliariello, Carla
2006-02-01
EdiPy is an online resource appropriately designed to simulate the evolution of plant mitochondrial genes in a biologically realistic fashion. EdiPy takes into account the presence of sites subjected to RNA editing and provides multiple artificial alignments corresponding to both genomic and cDNA sequences. Each artificial data set can successively be submitted to main and widespread evolutionary and phylogenetic software packages such as PAUP, Phyml, PAML and Phylip. As an online bioinformatic resource, EdiPy is available at the following web page: http://biologia.unical.it/py_script/index.html.
2010-07-01
... administrative claim using EDI or other electronic means? 102-118.550 Section 102-118.550 Public Contracts and... EDI or other electronic means? The medium and precise format of data for an administrative claim filed electronically must be approved in advance by the GSA Audit Division. GSA will use an authenticating EDI...
Kraan, Tamar C.; Ising, Helga K.; Fokkema, Marjolein; Velthorst, Eva; van den Berg, David P. G.; Kerkhoven, Margot; Veling, Wim; Smit, Filip; Linszen, Don H.; Nieman, Dorien H.; Wunderink, Lex; Boonstra, Nynke; Klaassen, Rianne M. C.; Dragt, Sara; Rietdijk, Judith; de Haan, Lieuwe; van der Gaag, Mark
2017-01-01
Childhood adversity is associated with a range of mental disorders, functional impairment and higher health care costs in adulthood. In this study we evaluated if childhood adversity was predictive of adverse clinical and functional outcomes and health care costs in a sample of patients at
Muhajarine, Nazeem; Puchala, Chassidy; Janus, Magdalena
2011-01-01
The aim of the current paper was to examine the equivalence of the Early Development Instrument (EDI), a teacher rating measure of school readiness, for Aboriginal and non-Aboriginal children. The current study used an approach, which analyzes the structure and properties of the EDI at the subdomain level. Similar subdomain score distributions…
Bayesian NL interpretation and learning
Zeevat, H.
2011-01-01
Everyday natural language communication is normally successful, even though contemporary computational linguistics has shown that NL is characterised by very high degree of ambiguity and the results of stochastic methods are not good enough to explain the high success rate. Bayesian natural language
Ontwerprapport 2005 kiesBeter.nl
Loon AJM van; PCAl Droomers; E Keesman; H Janssen; JAM Lijdsman; HB Mulder; Veen AA van der; Vrijsen WJJ; VTV
2005-01-01
Since September 2004 RIVM's Centre for Public Health Forecasting (VTV) in the Netherlands has been working on the development of an Internet portal for the general public called kiesBeter.nl ('Make a better choice'). Via this portal, consumers will have access to integrated information on health,
Evolution of fNL to the adiabatic limit
Elliston, Joseph; Mulryne, David J.; Seery, David; Tavakol, Reza
2011-11-01
We study inflationary perturbations in multiple-field models, for which ζ typically evolves until all isocurvature modes decay — the "adiabatic limit". We use numerical methods to explore the sensitivity of the local-shape bispectrum to the process by which this limit is achieved, finding an appreciable dependence on model-specific data such as the time at which slow-roll breaks down or the timescale of reheating. In models with a sum-separable potential where the isocurvature modes decay before the end of the slow-roll phase we give an analytic criterion for the asymptotic value of fNL to be large. Other examples can be constructed using a waterfall field to terminate inflation while fNL is transiently large, caused by descent from a ridge or convergence into a valley. We show that these two types of evolution are distinguished by the sign of the bispectrum, and give approximate expressions for the peak fNL.
Evolution of fNL to the adiabatic limit
International Nuclear Information System (INIS)
Elliston, Joseph; Mulryne, David J.; Tavakol, Reza; Seery, David
2011-01-01
We study inflationary perturbations in multiple-field models, for which ζ typically evolves until all isocurvature modes decay — the a diabatic limit . We use numerical methods to explore the sensitivity of the local-shape bispectrum to the process by which this limit is achieved, finding an appreciable dependence on model-specific data such as the time at which slow-roll breaks down or the timescale of reheating. In models with a sum-separable potential where the isocurvature modes decay before the end of the slow-roll phase we give an analytic criterion for the asymptotic value of f NL to be large. Other examples can be constructed using a waterfall field to terminate inflation while f NL is transiently large, caused by descent from a ridge or convergence into a valley. We show that these two types of evolution are distinguished by the sign of the bispectrum, and give approximate expressions for the peak f NL
Stofmisbrugsbehandling blandt grønlændere i Danmark
DEFF Research Database (Denmark)
Baviskar, Siddhartha
2016-01-01
undersøgelsen af en forløbsanalyse af en udvalgt gruppe på 221 grønlændere over en 5-årig periode, 2007-2011. Denne gruppe ankom for første gang til Danmark i 2007 og opholdt sig i landet i alle årene til og med 2011. Dermed opnår vi viden om både graden af sårbarhed blandt grønlænderne på stofmisbrugsområdet...... målt i forhold til de øvrige danskere, og hvordan grønlændernes sårbarhed ændrer sig over tid i Danmark. Oplysninger vedrørende stofmisbrugsbehandling stammer fra Register over stofmisbrugere i behandling (SIB), som er et register over borgere, der gennem deres kommune er visiteret til behandling...
International Nuclear Information System (INIS)
Huang, Yuhan; Hong, Guang
2016-01-01
Highlights: • Effect of EDI heating on the EDI + GPI engine performance was investigated. • CO and HC were significantly reduced and NO was slightly increased by EDI heating. • IMEP and combustion speed were slightly reduced by EDI heating. • EDI heating is effective to address the evaporation and over-cooling issues of EDI + GPI engine. - Abstract: Ethanol direct injection plus gasoline port injection (EDI + GPI) is a new technology to utilise ethanol fuel more efficiently and flexibly in spark ignition engines. One issue needs to be addressed in the development of EDI + GPI is the ethanol fuel’s low vapour pressure and large latent heat which slow down the ethanol’s evaporation and result in the mixture unready for combustion by the time of spark ignition and the consequent increase of CO and HC emissions. Heating the ethanol fuel to be directly injected (EDI heating) has been proposed to address this issue. This paper reports the investigation of the effect of EDI heating on the combustion and emissions of a research engine equipped with EDI + GPI. The results showed that EDI heating effectively reduced the CO and HC emissions of the engine due to the increase of evaporation rate and reduced fuel impingement and local over-cooling. The reduction of CO and HC became more significant with the increase of ethanol ratio. When the temperature of the ethanol fuel was increased by 40 °C, the CO and HC were reduced by as much as 43% and 51% respectively in EDI only condition at the original spark timing of 15 CAD BTDC, and 15% and 47% respectively at the minimum spark advance for best torque (MBT) timing of 19 CAD BTDC. On the other hand, the NO emission was slightly increased, but still much smaller than that in GPI only condition due to the strong cooling effect and low combustion temperature of EDI. The IMEP and combustion speed were slightly reduced by EDI heating due to the decrease of injector fuel flow rate and spray collapse of flash-boiling. The
Optomechanical fabrication of EDiFiSE spectrometer
Arredondo-Vega, Luis; Pérez-Santos, Carlos; Pompa-Carrera, Octavio; Ruiz-Márquez, Armando; Hurtado-Ortega, José; Paez, Gonzalo
2011-09-01
The purpose of this work is to describe some optical and mechanical issues relating to the fabrication of the camera and the collimator of the Equalized and Diffraction-Limited Field Spectrograph Experiment (EDiFiSE), an instrument which forms part of a bigger project of the Instituto de Astrofísica de Canarias (IAC), Spain, and that was designed and manufactured within the facilities of Centro de Investigaciones en Óptica in León, México.
João Cândido André da Silva Neto; Thiago Oliveira Neto
2017-01-01
A sexta edição especial da Revista Geonorte acaba de ser publicada, contemplando os trabalhos submetidos e aceitos ao V Encontro dos Estudantes de Geografia do Amazonas-EEGAM com o tema: Geografia da Circulação, realizado nas dependências do Instituto de Ciências Humanas e Letras-ICHL entre 29 e 30 de novembro e 01 e 02 de dezembro de 2016.
Directory of Open Access Journals (Sweden)
Nelly Oktavia Adiwijaya
2015-03-01
Full Text Available Fertilizer distribution from distributor to agents, are required to be responsive in addressing the demand for fertilizers. Distributors are also required to be able to manage inventory in the warehouse, to avoid overstocking of fertilizer. Design and implementation of a fertilizer retail electronic commerce applications using electronic data interchange (EDI method is applied in this study. The system is built to help distributors to control the existence of the stock of fertilizer so no excess stock. In addition, the use of EDI can provide information quickly (real-time without having to go directly to the warehouse locations.
Directory of Open Access Journals (Sweden)
Berkhout Ben
2005-02-01
Full Text Available Abstract Background Four human coronaviruses are currently known to infect the respiratory tract: human coronaviruses OC43 (HCoV-OC43 and 229E (HCoV-229E, SARS associated coronavirus (SARS-CoV and the recently identified human coronavirus NL63 (HCoV-NL63. In this study we explored the incidence of HCoV-NL63 infection in children diagnosed with respiratory tract infections in Belgium. Methods Samples from children hospitalized with respiratory diseases during the winter seasons of 2003 and 2004 were evaluated for the presence of HCoV-NL63 using a optimized pancoronavirus RT-PCR assay. Results Seven HCoV-NL63 positive samples were identified, six were collected during January/February 2003 and one at the end of February 2004. Conclusions Our results support the notation that HCoV-NL63 can cause serious respiratory symptoms in children. Sequence analysis of the S gene showed that our isolates could be classified into two subtypes corresponding to the two prototype HCoV-NL63 sequences isolated in The Netherlands in 1988 and 2003, indicating that these two subtypes may currently be cocirculating.
Huang, Su-Hua; Su, Mei-Chi; Tien, Ni; Huang, Chien-Jhen; Lan, Yu-Ching; Lin, Chen-Sheng; Chen, Chao-Hsien; Lin, Cheng-Wen
2017-12-01
Human coronavirus (HCoV) NL63 is recognized in association with upper or lower respiratory tract illnesses in children. This study surveyed the prevalence of HCoV-NL63 and influenza viruses in patients with influenza-like illness in Taiwan during 2010-2011. Throat samples from 107 hospitalized patients with pneumonia and 175 outpatients with influenza-like illness were examined using real-time polymerase chain reaction assays with virus-specific primers, and then virus-positive specimens were confirmed by sequencing the polymerase chain reaction products. HCoV-NL63 infection was identified in 8.4% (9/107) of hospitalized patients with pneumonia, but not found in outpatients with influenza-like illness. Age distribution of HCoV-NL63 infection in hospitalized patients with pneumonia indicated that the group aged 16-25 years (20%) had the highest positive rate compared with the other groups, and exhibited a similar age-specific pattern to influenza A/H1N1 infection, but not influenza A/H3N2 and B infections in hospitalized patients. Seasonal prevalence of HCoV-NL63 infection was late winter, overlapping the highest peak of the influenza A/H1N1 epidemic during December 2010 to March 2011 in Taiwan. Co-infection of HCoV-NL63 and influenza A/H1N1 was detected in three hospitalized patients. Clinical manifestation analysis indicated that the main symptoms for HCoV-NL63 infection included fever (88.9%), cough (77.8%), and pneumonia (100%). Co-infection caused significantly higher rates of breathing difficulties, cough, and sore throat than those of single infection with HCoV-NL63 and influenza A/H1N1. Phylogenetic analysis indicated a low level of heterogeneity between Taiwan and global HCoV-NL63 strains. Understanding epidemiology of HCoV-NL63 in Taiwan provides an insight for worldwide surveillance of HCoV-NL63 infection. Copyright © 2015. Published by Elsevier B.V.
Directory of Open Access Journals (Sweden)
João Cândido André da Silva Neto
2017-05-01
Full Text Available A sexta edição especial da Revista Geonorte acaba de ser publicada, contemplando os trabalhos submetidos e aceitos ao V Encontro dos Estudantes de Geografia do Amazonas-EEGAM com o tema: Geografia da Circulação, realizado nas dependências do Instituto de Ciências Humanas e Letras-ICHL entre 29 e 30 de novembro e 01 e 02 de dezembro de 2016.
Evolution of f{sub NL} to the adiabatic limit
Energy Technology Data Exchange (ETDEWEB)
Elliston, Joseph; Mulryne, David J.; Tavakol, Reza [School of Physics and Astronomy, Queen Mary University of London, Mile End Road, London E1 4NS (United Kingdom); Seery, David, E-mail: J.Elliston@qmul.ac.uk, E-mail: D.Mulryne@qmul.ac.uk, E-mail: D.Seery@sussex.ac.uk, E-mail: R.Tavakol@qmul.ac.uk [Astronomy Centre, University of Sussex, Falmer, Brighton BN1 9QH (United Kingdom)
2011-11-01
We study inflationary perturbations in multiple-field models, for which ζ typically evolves until all isocurvature modes decay — the {sup a}diabatic limit{sup .} We use numerical methods to explore the sensitivity of the local-shape bispectrum to the process by which this limit is achieved, finding an appreciable dependence on model-specific data such as the time at which slow-roll breaks down or the timescale of reheating. In models with a sum-separable potential where the isocurvature modes decay before the end of the slow-roll phase we give an analytic criterion for the asymptotic value of f{sub NL} to be large. Other examples can be constructed using a waterfall field to terminate inflation while f{sub NL} is transiently large, caused by descent from a ridge or convergence into a valley. We show that these two types of evolution are distinguished by the sign of the bispectrum, and give approximate expressions for the peak f{sub NL}.
Energy Technology Data Exchange (ETDEWEB)
NONE
1995-01-10
This report provides a summary of the Air Force CALS Test Network (AFCTN) Test Report Transfer of Air Force Technical Procurement Bid Set Data to Small Businesses, Using CALS and EDI (AFCTN Test Report 94-034, UCRL-ID-118619). It represents a synthesis of the results, conclusions, and recommendations, as well as a more concise presentation of the issues and strategies as viewed from AFCTN`s perspective. This report documents a test transfer of three Air Force technical procurement bid sets to one large and twelve small businesses, using the Department of Defense (DoD) Continuous Acquisition and Life-cycle Support (CALS) and ANSI ASC X12 Electronic Data Interchange (EDI) standards. The main goal of the test was to evaluate the effectiveness of using CALS technical data within the context of the DoD`s EDI-based standard approach to electronic commerce in procurement, with particular emphasis on receipt and use of the data by small contractors. Air Force procurement data was provided by the Sacramento Air Logistics Center at McClellan Air Force Base; the manufacturing participants were selected from among McClellan`s {open_quote}Blue Ribbon{close_quote} contractors, located throughout the United States. The test was sponsored by the Air Force CALS Test Network, headquartered at Wright-Patterson Air Force Base. The test successfully demonstrated the technical feasibility of including CALS MIL-R-28002 (Raster) engineering data in an EDI Specification/Technical Information transaction set (ANSI ASC X12 841) when issuing electronic requests for quotation to small businesses. In many cases, the data was complete enough for the contractor participant to feel comfortable generating a quote.
Stratejik Yönlülüklerin Yenilik ve Performans Üzerindeki Etkisi
OFLAZOĞLU, Sonyel; KOÇAK, Akın
2012-01-01
Bu çalışma; işletmelerin stratejik yönlülüklerinin (pazar yönlülük, girişimci yönlülük ve teknoloji yönlülük) yenilik ve performans üzerindeki etkisini ortaya koymayı amaçlamaktadır. Çalışmada stratejik yönlülüklerin hem finansal başarıda hem de müşteri değeri yaratmada yenilik aracılığıyla olumlu etkilerin olduğu varsayımı altında bir model geliştirilmiştir. Çalışma endüstriyel firmalarla sınırlanmıştır. Türkiye’de sanayisi gelişmiş 12 il’deki 845 işletme üzerinde yapılmıştır. Verilerin anal...
Ontwerprapport kiesBeter.nl 2006-2007
Loon AJM van; Tolboom RAL; VTV
2006-01-01
KiesBeter.nl (Make better choices) is a Dutch public Internet portal offering viewers answers to all their questions on health and health care. This is an initiative of the Dutch Ministry of Health, Welfare and Sport set up to encourage well-informed citizens to play a greater role in the
Mediterranean Style Diet and 12-Year Incidence of Cardiovascular Diseases: The Epic-NL Cohort Stusy
Hoevenaar-Blom, M.P.; Nooyens, A.J.C.; Kromhout, D.; Spijkerman, A.M.W.; Beulens, W.J.; Schouw, van der Y.T.; Bueno-de-Mesquita4, B.; Verschuren, W.M.M.
2012-01-01
Background: A recent meta-analysis showed that a Mediterranean style diet may protect against cardiovascular diseases (CVD). Studies on disease-specific associations are limited. We evaluated the Mediterranean Diet Score (MDS) in relation to incidence of total and specific CVDs. Methods: The EPIC-NL
International Nuclear Information System (INIS)
Huang, Yuhan; Hong, Guang; Huang, Ronghua
2015-01-01
Highlights: • A 5D PDF table was used to model the dual-fuel turbulence–chemistry interactions. • The cooling effect of ethanol direct injection (EDI) was examined. • The higher flame speed of ethanol in EDI + GPI increased the thermal efficiency. • The partially premixed combustion in EDI + GPI reduced the combustion temperature. • Ethanol’s low evaporation rate in low temperature led to incomplete combustion. - Abstract: Ethanol direct injection plus gasoline port injection (EDI + GPI) is a new technology to make the use of ethanol fuel more effective and efficient in spark ignition engines. Multi-dimensional computational fluid dynamics modelling was conducted on an EDI + GPI engine in both single and dual fuelled conditions. The in-cylinder flow field was solved in the realizable k−ε turbulence model with detailed engine geometry. The temporal and spatial distributions of the liquid and vapour fuels were simulated with the spray breakup and evaporation models. The combustion process was modelled with the partially premixed combustion concept in which both mixture fraction and progress variable were solved. The three-dimensional and five-dimensional presumed Probability Density Function (PDF) look-up tables were used to model the single-fraction-mixture and two-fraction-mixture turbulence–chemistry interactions respectively. The model was verified by comparing the numerical and experimental results of spray pattern and cylinder pressure. The simulation results showed that the combustion process of EDI + GPI dual-fuelled condition was partially premixed combustion because of the low evaporation rate of ethanol spray in low temperature environment before combustion. Compared with GPI only, the higher flame speed of ethanol fuel contributed to the greater pressure rise rate and maximum cylinder pressure in EDI + GPI condition, which consequently resulted in higher power output and thermal efficiency. The lower adiabatic flame temperature of
Dai, Chong-Hua; Sun, Jun; Chen, Kun-Quan; Zhang, Hui-Bo
In the present study, we explored the effectiveness and complications of omnidirectional internal fixation using a double approach for treating Rüedi-Allgöwer type III pilon fractures. A retrospective analysis was performed of 19 cases of Rüedi-Allgöwer type III unilateral closed pilon fracture. With preoperative preparation and correct surgical timing, the reduction was performed using anteromedial and posterolateral approaches, and the fracture fragments were fixed by omnidirectional internal fixation. Imaging evaluation was performed using the Burwell-Charnley scoring system. The Johner-Wruhs scoring system was used to assess the functional status of the patients. A comprehensive evaluation of efficacy was performed using a 5-point Likert score. The complications were also recorded and analyzed. All patients were followed up for an average of 16.2 months. The operative incisions of 15 cases healed by primary intent and with delayed healing in 4. All patients had achieved bony union at an average of 16 weeks postoperatively. No deep infection, broken nail or withdrawn nail, exposed plate, or skin flap necrosis occurred. The Burwell-Charnley imaging evaluation showed that 14 patients had anatomic reduction of the articular surface and 5 had acceptable reduction. Using the Johner-Wruhs scoring system, the results were excellent for 8, good for 7, fair for 2, and poor for 2 patients; the combined rate of excellent and good results was 78.9%. The Likert score of efficacy self-reported by the patients was 3 to 4 points for 12 patients, 2 points for 4 patients, and 0 to 1 point for 3 patients. The Likert score of therapeutic efficacy reported by the physicians was 3 to 4 points for 10 patients, 2 points for 5 patients, and 0 to 1 point for 4 patients. Omnidirectional internal fixation using double approaches was an effective method to treat Rüedi-Allgöwer type III pilon fractures with satisfactory reduction and rigid fixation, good joint function recovery, and
Direct Observations of ULF and Whistler-Mode Chorus Modulation of 500eV EDI Electrons by MMS
Paulson, K. W.; Argall, M. R.; Ahmadi, N.; Torbert, R. B.; Le Contel, O.; Ergun, R.; Khotyaintsev, Y. V.; Strangeway, R. J.; Magnes, W.; Russell, C. T.
2016-12-01
We present here direct observations of chorus-wave modulated field-aligned 500 eV electrons using the Electron Drift Instrument (EDI) on board the Magnetospheric Multiscale mission. These periods of wave activity were additionally observed to be modulated by Pc5-frequency magnetic perturbations, some of which have been identified as drifting mirror-mode structures. The spacecraft encountered these mirror-mode structures just inside of the duskside magnetopause. Using the high sampling rate provided by EDI in burst sampling mode, we are able to observe the individual count fluctuations of field-aligned electrons in this region up to 512 Hz. We use the multiple look directions of EDI to generate both pitch angle and gyrophase plots of the fluctuating counts. Our observations often show unidirectional flow of these modulated electrons along the background field, and in some cases demonstrate gyrophase bunching in the wave region.
Ouyang, Jia; Cai, Cong; Chen, Hai; Jiang, Ting; Zheng, Zhaojuan
2012-12-01
Xylose is the major pentose and the second most abundant sugar in lignocellulosic feedstock. Its efficient utilization is regarded as a technical barrier to the commercial production of bulk chemicals from lignocellulosic biomass. This work aimed at evaluating the lactic acid production from the biomass-derived xylose using non-sterilized fermentation by Bacillus coagulans NL01. A maximum lactic acid concentration of about 75 g/L was achieved from xylose of 100 g/L after 72 h batch fermentation. Acetic acid and levulinic acid were identified as important inhibitors in xylose fermentation, which markedly reduced lactic acid productivity at 15 and 1.0 g/L, respectively. But low concentrations of formic acid (coagulans NL01, the same preference for glucose, xylose, and arabinose was observed and18.2 g/L lactic acid was obtained after 48 h fermentation. These results proved that B. coagulans NL01 was potentially well-suited for producing lactic acid from underutilized xylose-rich prehydrolysates.
Veskari, Hassan; Pouralkhas, Shokrollah; Moharrami, Ramin; Ranjbar, Ebrahim
2017-01-01
Gholam Hussein Sa'edi is one of the greatest Iranian writers of short stories in the present era. Sa'edi's stories are based on the existence of fanciful and dreamlike settings in which he attempts to establish the endings of the stories to be the direct result of the characters' psychological reaction against their dreams. The linguistic and…
Plaque assay for human coronavirus NL63 using human colon carcinoma cells
Directory of Open Access Journals (Sweden)
Drosten Christian
2008-11-01
Full Text Available Abstract Background Coronaviruses cause a broad range of diseases in animals and humans. Human coronavirus (hCoV NL63 is associated with up to 10% of common colds. Viral plaque assays enable the characterization of virus infectivity and allow for purifying virus stock solutions. They are essential for drug screening. Hitherto used cell cultures for hCoV-NL63 show low levels of virus replication and weak and diffuse cytopathogenic effects. It has not yet been possible to establish practicable plaque assays for this important human pathogen. Results 12 different cell cultures were tested for susceptibility to hCoV-NL63 infection. Human colon carcinoma cells (CaCo-2 replicated virus more than 100 fold more efficiently than commonly used African green monkey kidney cells (LLC-MK2. CaCo-2 cells showed cytopathogenic effects 4 days post infection. Avicel, agarose and carboxymethyl-cellulose overlays proved suitable for plaque assays. Best results were achieved with Avicel, which produced large and clear plaques from the 4th day of infection. The utility of plaque assays with agrose overlay was demonstrated for purifying virus, thereby increasing viral infectivity by 1 log 10 PFU/mL. Conclusion CaCo-2 cells support hCoV-NL63 better than LLC-MK2 cells and enable cytopathogenic plaque assays. Avicel overlay is favourable for plaque quantification, and agarose overlay is preferred for plaque purification. HCoV-NL63 virus stock of increased infectivity will be beneficial in antiviral screening, animal modelling of disease, and other experimental tasks.
Validation of Multilevel Constructs: Validation Methods and Empirical Findings for the EDI
Forer, Barry; Zumbo, Bruno D.
2011-01-01
The purposes of this paper are to highlight the foundations of multilevel construct validation, describe two methodological approaches and associated analytic techniques, and then apply these approaches and techniques to the multilevel construct validation of a widely-used school readiness measure called the Early Development Instrument (EDI;…
Drought severity in intensive agricultural areas by means of the EDI index
Procházková, Petra; Chuchma, Filip; Středa, Tomáš
2016-12-01
The aim of this work was the evaluation of drought severity development in the Czech Republic for the period 1971-2015 by the means of the Effective Drought Index (EDI). Annual values of the EDI index were determined using the method of effective precipitation for 14 localities spread throughout the Czech Republic (Central Europe). The seven categories were created according to obtained index values for the drought conditions determination for years during the period 1971-2015 through the percentile method. The annual index values were compared with acquired 2nd, 15th, 45th, 55th, 85th and 98th percentiles. Both the years with precipitation unfavourable conditions: 1972, 1973, 1984, 1990, 1991, 1992, 1993 and 2015 and the years with precipitation favourable conditions: 1977, 1987, 1995, 2001, 2002 and 2010 were determined. Precipitation conditions in the growing season from 61st to 180th day of the year were also analysed. This evaluation was conducted during the period 1971-2015 through the ten-day index values which were compared with acquired 2nd, 15th, 45th, 55th, 85th and 98th percentiles. Dry growing seasons occurred in 1973, 1974, 1976 and 1993. Wet growing seasons occurred in 1987, 2006 and 2010. Trend analysis of annual index values was performed through the Mann-Kendall test. Highly statistically significant increasing linear trends (P < 0.01) were found for four localities (Uherský Ostroh, Vysoká, Znojmo-Oblekovice and Žatec); statistically significant increasing trends (P < 0.05) were found for three localities (Brno-Chrlice, Lednice and Lípa). Based on the extrapolation of the trend, a slightly higher effective precipitation can be expected during the year in a substantial part of the country. However, these findings do not necessarily mean an optimal supply of agricultural land with water. Precipitation exhibits considerable unevenness of distribution through time. Given the increasing evapotranspiration demands of the environment their
NL(q) Theory: A Neural Control Framework with Global Asymptotic Stability Criteria.
Vandewalle, Joos; De Moor, Bart L.R.; Suykens, Johan A.K.
1997-06-01
In this paper a framework for model-based neural control design is presented, consisting of nonlinear state space models and controllers, parametrized by multilayer feedforward neural networks. The models and closed-loop systems are transformed into so-called NL(q) system form. NL(q) systems represent a large class of nonlinear dynamical systems consisting of q layers with alternating linear and static nonlinear operators that satisfy a sector condition. For such NL(q)s sufficient conditions for global asymptotic stability, input/output stability (dissipativity with finite L(2)-gain) and robust stability and performance are presented. The stability criteria are expressed as linear matrix inequalities. In the analysis problem it is shown how stability of a given controller can be checked. In the synthesis problem two methods for neural control design are discussed. In the first method Narendra's dynamic backpropagation for tracking on a set of specific reference inputs is modified with an NL(q) stability constraint in order to ensure, e.g., closed-loop stability. In a second method control design is done without tracking on specific reference inputs, but based on the input/output stability criteria itself, within a standard plant framework as this is done, for example, in H( infinity ) control theory and &mgr; theory. Copyright 1997 Elsevier Science Ltd.
Energy Technology Data Exchange (ETDEWEB)
Wu, Kailang; Li, Weikai; Peng, Guiqing; Li, Fang; (Harvard-Med); (UMM-MED)
2010-03-04
NL63 coronavirus (NL63-CoV), a prevalent human respiratory virus, is the only group I coronavirus known to use angiotensin-converting enzyme 2 (ACE2) as its receptor. Incidentally, ACE2 is also used by group II SARS coronavirus (SARS-CoV). We investigated how different groups of coronaviruses recognize the same receptor, whereas homologous group I coronaviruses recognize different receptors. We determined the crystal structure of NL63-CoV spike protein receptor-binding domain (RBD) complexed with human ACE2. NL63-CoV RBD has a novel {beta}-sandwich core structure consisting of 2 layers of {beta}-sheets, presenting 3 discontinuous receptor-binding motifs (RBMs) to bind ACE2. NL63-CoV and SARS-CoV have no structural homology in RBD cores or RBMs; yet the 2 viruses recognize common ACE2 regions, largely because of a 'virus-binding hotspot' on ACE2. Among group I coronaviruses, RBD cores are conserved but RBMs are variable, explaining how these viruses recognize different receptors. These results provide a structural basis for understanding viral evolution and virus-receptor interactions.
Avanzato, Daniele; Pupo, Emanuela; Ducano, Nadia; Isella, Claudio; Bertalot, Giovanni; Luise, Chiara; Pece, Salvatore; Bruna, Alejandra; Rueda, Oscar M; Caldas, Carlos; Di Fiore, Pier Paolo; Sapino, Anna; Lanzetti, Letizia
2018-04-24
USP6NL, also named RN-tre, is a GTPase activating protein (GAP) involved in control of endocytosis and signal transduction. Here we report that USP6NL is overexpressed in breast cancer (BC), mainly of the basal-like/integrative cluster 10 subtype. Increased USP6NL levels were accompanied by gene amplification and were associated with worse prognosis in the METABRIC dataset, retaining prognostic value in multivariable analysis. High levels of USP6NL in BC cells delayed endocytosis and degradation of the epidermal growth factor receptor (EGFR), causing chronic AKT activation. In turn, AKT stabilized the glucose transporter GLUT1 at the plasma membrane, increasing aerobic glycolysis. In agreement, elevated USP6NL sensitized BC cells to glucose deprivation, indicating that their glycolytic capacity relies on this protein. Depletion of USP6NL accelerated EGFR/AKT downregulation and GLUT1 degradation, impairing cell proliferation exclusively in BC cells that harbored increased levels of USP6NL. Overall, these findings argue that USP6NL overexpression generates a metabolic rewiring that is essential to foster the glycolytic demand of BC cells and promote their proliferation. Copyright ©2018, American Association for Cancer Research.
Wang, Wei-Xia; Li, Kai-Long; Chen, Yang; Lai, Feng-Xiang; Fu, Qiang
2015-01-01
The enolase [EC 4.2.1.11] is an essential enzyme in the glycolytic pathway catalyzing the conversion of 2-phosphoglycerate (2-PGE) to phosphoenolpyruvate (PEP). In this study, a full-length cDNA encoding α-enolase was cloned from rice brown planthopper (Nilaparvata lugens) and is provisionally designated as NlEno1. The cDNA sequence of NlEno1 was 1,851 bp with an open reading frame (ORF) of 1,305 bp and encoding 434 amino acids. The deduced protein shares high identity of 80–87% with ENO1-like protein from Hemiptera, Diptera, and Lepidoptera speices. The NlEno1 showed the highest mRNA expression level in hemolymph, followed by fat body, salivary gland, ovaries and egg, and showed trace mRNA levels in testis. The mRNA of NlEno1 showed up-regulated level in virulent N. lugens population Mudgo, IR56 and IR42 when compared with TN1 population. Injection of double-stranded RNA (dsRNA) of NlEno1 into the adults significantly down-regulated the NlEno1 mRNA level along with decreased eggs and offspring. Moreover, injection of NlEno1-dsRNA decreased mRNA level of Vitellogenin (Vg) gene. These results showed that the NlEno1, as a key glycolytic enzyme, may play roles in regulation of fecundity and adaptation of N. lugens to resistant rice varieties. PMID:26056319
Energy Technology Data Exchange (ETDEWEB)
Sigrist, Manuel [Swan Systeme AG, Hinwil (Switzerland)
2017-10-15
The conductivity measurement after a cation exchanger in power plants with steam turbines was introduced soon after 1950 by Larson and Lane. Due to the simple measuring principle, the sensitivity to ionic contaminations and to its high reliability, the conductivity measurement after a cation exchanger (CACE) has become the most commonly used online analytical method in power plants with steam generators. Swan has investigated electro deionisation (EDI) as substitution of the conventional cation exchange resin and has developed a new conductivity instrument using this principle. This paper provides a description of the conventional method for cation conductivity measurements as well as of the new AMI CACE using EDI method.
International Nuclear Information System (INIS)
Sigrist, Manuel
2017-01-01
The conductivity measurement after a cation exchanger in power plants with steam turbines was introduced soon after 1950 by Larson and Lane. Due to the simple measuring principle, the sensitivity to ionic contaminations and to its high reliability, the conductivity measurement after a cation exchanger (CACE) has become the most commonly used online analytical method in power plants with steam generators. Swan has investigated electro deionisation (EDI) as substitution of the conventional cation exchange resin and has developed a new conductivity instrument using this principle. This paper provides a description of the conventional method for cation conductivity measurements as well as of the new AMI CACE using EDI method.
Identification of Disciplines and Fields. Edis Task I Report, Work Unit 1.4.
Howard Research Co., Arlington, VA.
This report presents the identification and definitions of subject oriented engineering and scientific disciplines and fields which are included in the EDIS Subject Categories. The discussion is extended to include the mix of subjects with other orientations, such as Item, Mission-Project, Expertise and Data Bank Categories. Sample queries are…
Reininga, Inge H F; Brouwer, Sandra; Dijkstra, Anita; Busse, Jason W; Ebrahim, Shanil; Wendt, Klaus W; El Moumni, Mostafa
2015-02-01
Positive coping strategies, illness perceptions and recovery expectations are associated with better clinical outcomes and earlier return to work after injuries. The Somatic Pre-Occupation and Coping (SPOC) questionnaire captures illness beliefs and coping towards recovery of physical function and return to work after surgical treatment of tibial shaft fractures. The aim of this study was to translate and culturally adapt the SPOC into Dutch (SPOC-NL) and evaluate its reliability and validity in patients with lower extremity injuries. The SPOC-NL contains four subscales: Somatic complaints, Coping, Energy, and Optimism. Patients treated for lower extremity injuries (N=106) completed the SPOC-NL, Short Form-36 and Short Musculoskeletal Function Assessment (SMFA-NL) questionnaire, and reported their current work status and self-perceived work ability. To assess test-retest reliability, 56 patients completed the SPOC-NL for a second time two weeks after the first administration of the SPOC-NL. We calculated Cronbach's Alpha, intraclass correlation coefficients (ICCs) and G coefficients to measure internal consistency and overall reliability, and used the Bland and Altman method to assess bias between test and retest SPOC-NL scores. To determine construct validity, we explored 16 a priori hypotheses regarding correlations between SPOC-NL scores and subscale scores and SF-36, SMFA-NL, work status and work ability. Internal consistency was good to excellent, with Cronbach's Alpha values ranging between 0.79 and 0.94 and G coefficients ranging between 0.77 and 0.95. Test-retest reliability was also good, since high ICCs (0.72-0.91) and G coefficients (0.82-0.94) were found. Construct validity of the SPOC-NL was good, as 75% of the predefined hypotheses were confirmed. Compared to participants who were on sick leave or receiving disability benefits, participants with a paid job had significantly higher scores on the total score and the subscales Somatic complaints and
Oggioni, Alessandro; Tagliolato, Paolo; Fugazza, Cristiano; Bastianini, Mauro; Pavesi, Fabio; Pepe, Monica; Menegon, Stefano; Basoni, Anna; Carrara, Paola
2015-04-01
Sensor observation systems for environmental data have become increasingly important in the last years. The EGU's Informatics in Oceanography and Ocean Science track stressed the importance of management tools and solutions for marine infrastructures. We think that full interoperability among sensor systems is still an open issue and that the solution to this involves providing appropriate metadata. Several open source applications implement the SWE specification and, particularly, the Sensor Observation Services (SOS) standard. These applications allow for the exchange of data and metadata in XML format between computer systems. However, there is a lack of metadata editing tools supporting end users in this activity. Generally speaking, it is hard for users to provide sensor metadata in the SensorML format without dedicated tools. In particular, such a tool should ease metadata editing by providing, for standard sensors, all the invariant information to be included in sensor metadata, thus allowing the user to concentrate on the metadata items that are related to the specific deployment. RITMARE, the Italian flagship project on marine research, envisages a subproject, SP7, for the set-up of the project's spatial data infrastructure. SP7 developed EDI, a general purpose, template-driven metadata editor that is composed of a backend web service and an HTML5/javascript client. EDI can be customized for managing the creation of generic metadata encoded as XML. Once tailored to a specific metadata format, EDI presents the users a web form with advanced auto completion and validation capabilities. In the case of sensor metadata (SensorML versions 1.0.1 and 2.0), the EDI client is instructed to send an "insert sensor" request to an SOS endpoint in order to save the metadata in an SOS server. In the first phase of project RITMARE, EDI has been used to simplify the creation from scratch of SensorML metadata by the involved researchers and data managers. An interesting by
Superfund record of decision (EPA Region 2): NL Industries, Inc. , Pedricktown, NJ, July 1994
Energy Technology Data Exchange (ETDEWEB)
1994-07-08
This Record of Decision documents the U.S. Environmental Protection Agency's (EPA's) selection of the remedial action for the NL Industries, Inc. site. The remedial action described in this document represents the second of two planned phases, or operable units, at the NL Industries site. This action, designated as Operable Unit One, addresses contaminated ground water, surface water, soils and stream sediments at the site.
Zhang, Fei; Zhang, Bing; Xie, Zhi-Ping; Gao, Han-Chun; Zhao, Xin; Zhong, Li-Li; Zhou, Qiong-Hua; Hou, Yun-De; Duan, Zhao-Jun
2012-04-01
The main objective of this study was to explore the prevalence and clinical characteristics of human coronavirus NL63 infection in hospitalized children with acute lower respiratory tract infection (ALRTI) in Changsha. Nasopharyngeal aspirates (NPA) samples were collected from 1185 hospitalized children with ALRTI at the People's Hospital of Hunan province, between September 2008 and October 2010. Reverse transcriptase polymerase chain reaction (RT-PCR) was employed to screen for coronavirus NL63, which is a 255 bp fragment of a part of N gene. All positive amplification products were confirmed by sequencing and compared with those in GenBank. The overall frequency of coronavirus NL63 infection was 0.8%, 6 (60%) out of the coronavirus NL63 positive patients were detected in summer, 2 in autumn, 1 in spring and winter, respectively. The patients were from 2 months to two and a half years old. The clinical diagnosis was bronchopneumonia (60%), bronchiolitis (30%), and acute laryngotracheal bronchitis (10%). Four of the 10 cases had critical illness, 4 cases had underlying diseases, and 7 cases had mixed infection with other viruses. The homogeneity of coronavirus NL63 with those published in the GenBank at nucleotide levels was 97%-100%. Coronavirus NL63 infection exists in hospitalized children with acute lower respiratory tract infection in Changsha. Coronavirus NL63 infections are common in children under 3 years of age. There is significant difference in the infection rate between the boys and the girls: the boys had higher rate than the girls. The peak of prevalence of the coronavirus NL63 was in summer. A single genetic lineage of coronavirus NL63 was revealed in human subjects in Changsha. Coronavirus NL63 may also be one of the lower respiratory pathogen in China.
Evaluation of Potential Biological Threats in Ukraine
International Nuclear Information System (INIS)
Pozdnyakova, L.; Slavina, N.; Pozdnyakov, S.
2007-01-01
Dilating of biological threats spectrum, EDI diffusion opportunities and routes, unpredictability of outbreaks connected with connatural, technogenic, terrorist factors determines constant monitoring and readiness for operative BPA indication and identification. Scientific analytical approach of existing and probable regional bio-threats evaluation is necessary for adequate readiness system creation and maintenance of medical counteraction tactics to probable biological threats. Basing on the international experience, we carry out analysis of a situation present in Ukraine and routes for the decisions. The basic directions are: - Evaluation of a reality for EDI penetration from abroad and presence of conditions for their further diffusion inside the country. - Revealing of presence and definition of connatural EDI foci biocenoses features and BPAs. - Appropriate level of biological safety and physical protection of bio-laboratories and pathogens collections maintenance. - Gene/molecular and phenotypical definition of EDI circulating strains. - Creation of the circulating EDI gene/ phenotypic characteristics regional data bank. - Ranging of EDI actual for area. - Introduction of GPT, mathematical modeling and forecasting for tactics development in case of technogenic accidents and connatural outbreaks. - Methodical basis and equipment improvement for BPA system indication for well-timed identification of natural, or modified agent. - Education and training The international cooperation in maintenance of biosafety and bioprotection within the framework of scientific programs, grants, exchange of experience, introduction of international standards and rules are among basic factors in the decision for creating system national biosafety for countries not included in EU and the NATO. (author)
Directory of Open Access Journals (Sweden)
Rozalia Małgorzata Ligus
2013-12-01
Full Text Available This article’s aim is to describe some of the sources of the European debate over the third cycle studies in teacher education in Europe. Then it will introduce the international Project EDiTE as one of the collaborative initiatives concerning the European scientific proposal of the teachers’ lifelong learning development. Next, some good practices of promoting the doctoral research based teacher education on national levels will be presented. Finally, in the article, there will be revealed selected findings of the EDiTE team that are focused on the current needs in teacher education that have been pointed by different stakeholders of five European countries represented by the project consortium, while interviewing them in 2013 y. The main goal of this article is to involve the stakeholders in a thought provoking debate for future roles of teachers in Europe, but not through looking for a ‘standardized teacher model’ or to create a ‘European super teacher’, but to see the dilemmas that should be shared while questioning ‘What makes a teacher European?,’ as Michael Schratz underlines, in a diversity of national identities and in the face of challenges of 21st century.
Whyte, Lauren S; Hemsley, Kim M; Lau, Adeline A; Hassiotis, Sofia; Saito, Takashi; Saido, Takaomi C; Hopwood, John J; Sargeant, Timothy J
2018-01-15
The recent development of knock-in mouse models of Alzheimer's disease provides distinct advantages over traditional transgenic mouse models that rely on over-expression of amyloid precursor protein. Two such knock-in models that have recently been widely adopted by Alzheimer's researchers are the App NL-F and App NL-G-F mice. This study aimed to further characterise the behavioural phenotype and amyloid plaque distribution of App NL-G-F/NL-G-F (C57BL/6J background) mice at six-months of age. An attempt to replicate a previous study that observed deficits in working memory in the Y-maze, showed no difference between App NL-G-F/NL-G-F and wild-type mice. Further assessment of these mice using the novel object recognition test and Morris water maze also revealed no differences between App NL-G-F/NL-G-F and wild-type mice. Despite a lack of demonstrated cognitive deficits, we report a reduction in locomotor/exploratory activity in an open field. Histological examination of App NL-G-F/NL-G-F mice showed widespread distribution of amyloid plaques at this age. We conclude that whilst at six-months of age, memory deficits are not sufficiently robust to be replicated in varying environments, amyloid plaque burden is significant in App NL-G-F/NL-G-F knock-in brain. Copyright © 2017 Elsevier B.V. All rights reserved.
Shuster, J. R.; Torbert, R. B.; Vaith, H.; Argall, M. R.; Li, G.; Chen, L. J.; Ergun, R. E.; Lindqvist, P. A.; Marklund, G. T.; Khotyaintsev, Y. V.; Russell, C. T.; Magnes, W.; Le Contel, O.; Pollock, C. J.; Giles, B. L.
2015-12-01
The electron drift instruments (EDIs) onboard each MMS spacecraft are designed with large geometric factors (~0.01cm2 str) to facilitate detection of weak (~100 nA) electron beams fired and received by the two gun-detector units (GDUs) when EDI is in its "electric field mode" to determine the local electric and magnetic fields. A consequence of the large geometric factor is that "ambient mode" electron flux measurements (500 eV electrons having 0°, 90°, or 180° pitch angle) can vary depending on the orientation of the EDI instrument with respect to the magnetic field, a nonphysical effect that requires a correction. Here, we present determinations of the θ- and ø-dependent correction factors for the eight EDI GDUs, where θ (ø) is the polar (azimuthal) angle between the GDU symmetry axis and the local magnetic field direction, and compare the corrected fluxes with those measured by the fast plasma instrument (FPI). Using these corrected, high time resolution (~1,000 samples per second) ambient electron fluxes, combined with the unprecedentedly high resolution 3D electric field measurements taken by the spin-plane and axial double probes (SDP and ADP), we are equipped to accurately detect electron-scale current layers and electric field waves associated with the non-Maxwellian (anisotropic and agyrotropic) particle distribution functions predicted to exist in the reconnection diffusion region. We compare initial observations of the diffusion region with distributions and wave analysis from PIC simulations of asymmetric reconnection applicable for modeling reconnection at the Earth's magnetopause, where MMS will begin Science Phase 1 as of September 1, 2015.
Rojas Barahona , Lina Maria; Quaglini , Silvana; Stefanelli , Mario
2009-01-01
International audience; The prospective home-care management will probably of- fer intelligent conversational assistants for supporting patients at home through natural language interfaces. Homecare assistance in natural lan- guage, HomeNL, is a proof-of-concept dialogue system for the manage- ment of patients with hypertension. It follows up a conversation with a patient in which the patient is able to take the initiative. HomeNL pro- cesses natural language, makes an internal representation...
Bouman, Z.; Hendriks, M.P.; Kerkmeer, M.C.; Kessels, R.P.C.; Aldenkamp, A.P.
2015-01-01
The latent factor structure of the Dutch version of the Wechsler Memory Scale-Fourth Edition (WMS-IV-NL) was examined with a series of confirmatory factor analyses. As part of the Dutch standardization, 1,188 healthy participants completed the WMS-IV-NL. Four models were tested for the Adult Battery
Wang, Hangyao; Zhou, Qin; Zhang, Guangming; Yan, Guokai; Lu, Haifeng; Sun, Liyan
A novel process coupling photosynthetic bacteria (PSB) with electrodeionization (EDI) treatment was proposed to treat high ammonia wastewater and recover bio-resources and nitrogen. The first stage (PSB treatment) was used to degrade organic pollutants and accumulate biomass, while the second stage (EDI) was for nitrogen removal and recovery. The first stage was the focus in this study. The results showed that using PSB to transform organic pollutants in wastewater into biomass was practical. PSB could acclimatize to wastewater with a chemical oxygen demand (COD) of 2,300 mg/L and an ammonia nitrogen (NH4(+)-N) concentration of 288-4,600 mg/L. The suitable pH was 6.0-9.0, the average COD removal reached 80%, and the biomass increased by an average of 9.16 times. The wastewater COD removal was independent of the NH4(+)-N concentration. Moreover, the PSB functioned effectively when the inoculum size was only 10 mg/L. The PSB-treated wastewater was then further handled in an EDI system. More than 90% of the NH4(+)-N was removed from the wastewater and condensed in the concentrate, which could be used to produce nitrogen fertilizer. In the whole system, the average NH4(+)-N removal was 94%, and the average NH4(+)-N condensing ratio was 10.0.
Choroidal Thickness Analysis in Patients with Usher Syndrome Type 2 Using EDI OCT.
Colombo, L; Sala, B; Montesano, G; Pierrottet, C; De Cillà, S; Maltese, P; Bertelli, M; Rossetti, L
2015-01-01
To portray Usher Syndrome type 2, analyzing choroidal thickness and comparing data reported in published literature on RP and healthy subjects. Methods. 20 eyes of 10 patients with clinical signs and genetic diagnosis of Usher Syndrome type 2. Each patient underwent a complete ophthalmologic examination including Best Corrected Visual Acuity (BCVA), intraocular pressure (IOP), axial length (AL), automated visual field (VF), and EDI OCT. Both retinal and choroidal measures were measured. Statistical analysis was performed to correlate choroidal thickness with age, BCVA, IOP, AL, VF, and RT. Comparison with data about healthy people and nonsyndromic RP patients was performed. Results. Mean subfoveal choroidal thickness (SFCT) was 248.21 ± 79.88 microns. SFCT was statistically significant correlated with age (correlation coefficient -0.7248179, p patients (p = 0.2138). Conclusions. Our study demonstrated in vivo choroidal thickness reduction in patients with Usher Syndrome type 2. These data are important for the comprehension of mechanisms of disease and for the evaluation of therapeutic approaches.
Automated Generation of OCL Constraints: NL based Approach vs Pattern Based Approach
Directory of Open Access Journals (Sweden)
IMRAN SARWAR BAJWA
2017-04-01
Full Text Available This paper presents an approach used for automated generations of software constraints. In this model, the SBVR (Semantics of Business Vocabulary and Rules based semi-formal representation is obtained from the syntactic and semantic analysis of a NL (Natural Language (such as English sentence. A SBVR representation is easy to translate to other formal languages as SBVR is based on higher-order logic like other formal languages such as OCL (Object Constraint Language. The proposed model endows with a systematic and powerful system of incorporating NL knowledge on the formal languages. A prototype is constructed in Java (an Eclipse plug-in as a proof of the concept. The performance was tested for a few sample texts taken from existing research thesis reports and books
Temporal Stability of the Dutch Version of the Wechsler Memory Scale-Fourth Edition (WMS-IV-NL).
Bouman, Zita; Hendriks, Marc P H; Aldenkamp, Albert P; Kessels, Roy P C
2015-01-01
The Wechsler Memory Scale-Fourth Edition (WMS-IV) is one of the most widely used memory batteries. We examined the test-retest reliability, practice effects, and standardized regression-based (SRB) change norms for the Dutch version of the WMS-IV (WMS-IV-NL) after both short and long retest intervals. The WMS-IV-NL was administered twice after either a short (M = 8.48 weeks, SD = 3.40 weeks, range = 3-16) or a long (M = 17.87 months, SD = 3.48, range = 12-24) retest interval in a sample of 234 healthy participants (M = 59.55 years, range = 16-90; 118 completed the Adult Battery; and 116 completed the Older Adult Battery). The test-retest reliability estimates varied across indexes. They were adequate to good after a short retest interval (ranging from .74 to .86), with the exception of the Visual Working Memory Index (r = .59), yet generally lower after a long retest interval (ranging from .56 to .77). Practice effects were only observed after a short retest interval (overall group mean gains up to 11 points), whereas no significant change in performance was found after a long retest interval. Furthermore, practice effect-adjusted SRB change norms were calculated for all WMS-IV-NL index scores. Overall, this study shows that the test-retest reliability of the WMS-IV-NL varied across indexes. Practice effects were observed after a short retest interval, but no evidence was found for practice effects after a long retest interval from one to two years. Finally, the SRB change norms were provided for the WMS-IV-NL.
Choroidal Thickness Analysis in Patients with Usher Syndrome Type 2 Using EDI OCT
Colombo, L.; Sala, B.; Montesano, G.; Pierrottet, C.; De Cillà, S.; Maltese, P.; Bertelli, M.; Rossetti, L.
2015-01-01
To portray Usher Syndrome type 2, analyzing choroidal thickness and comparing data reported in published literature on RP and healthy subjects. Methods. 20 eyes of 10 patients with clinical signs and genetic diagnosis of Usher Syndrome type 2. Each patient underwent a complete ophthalmologic examination including Best Corrected Visual Acuity (BCVA), intraocular pressure (IOP), axial length (AL), automated visual field (VF), and EDI OCT. Both retinal and choroidal measures were measured. Stati...
Engel, R.; Aalst, van der W.M.P.; Zapletal, M.; Pichler, C.; Werthner, H.; Ralyté, J.; Franch, X.; Brinkkemper, S.; Wrycza, S.
2012-01-01
Traditional standards for Electronic Data Interchange (EDI), such as EDIFACT and ANSI X12, have been employed in Business-to-Business (B2B) e-commerce for decades. Due to their wide industry coverage and long-standing establishment, they will presumably continue to play an important role for some
Human Coronaviruses 229E and NL63: Close Yet Still So Far
Directory of Open Access Journals (Sweden)
Ronald Dijkman
2009-04-01
Full Text Available HCoV-NL63 and HCoV-229E are two of the four human coronaviruses that circulate worldwide. These two viruses are unique in their relationship towards each other. Phylogenetically, the viruses are more closely related to each other than to any other human coronavirus, yet they only share 65% sequence identity. Moreover, the viruses use different receptors to enter their target cell. HCoV-NL63 is associated with croup in children, whereas all signs suggest that the virus probably causes the common cold in healthy adults. HCoV-229E is a proven common cold virus in healthy adults, so it is probable that both viruses induce comparable symptoms in adults, even though their mode of infection differs. Here, we present an overview of the current knowledge on both human coronaviruses, focusing on similarities and differences.
Ratnasingam, Pauline
2001-01-01
This study examines behavioral dimensions of trading partner trust in EDI (electronic data interchange) adoption via a qualitative interpretative case study conducted between an automotive manufacturer (Ford Motor Company) in Australia and their first tier supplier, PBR Limited. Findings suggest that trust is important for cooperative long-term…
MijnOU.nl (proef met een sociale netwerkdienst binnen de Open Universiteit)
Eshuis, Jannes; Hermans, Henry
2010-01-01
Doel van het project Mijnou.nl Het ideaal van een volledig gepersonaliseerd startportaal, waarin studenten via een Single Sign On (SSO) toegang vinden tot al het leermateriaal waarop zij rechten hebben verworven, relevante informatie vinden over activiteiten op studiecentra, contacten kunnen
Variantes textuais no Livro do Desassossego: edição, codificação e interpretação
Directory of Open Access Journals (Sweden)
Diego Giménez
2016-09-01
Full Text Available http://dx.doi.org/10.5007/1807-9288.2016v12n1p54 Em 1988, Ivo Castro, responsável pela edição crítica da obra de Fernando Pessoa para a Imprensa Nacional Casa da Moeda, perguntava, numa comunicação intitulada “Edição Crítica de Pessoa: O Modelo Editorial Adoptado”: “como negar ao leitor o máximo de conhecimento sobre o que está escrito por Pessoa nos manuscritos, quando sabemos que dentro de uma geração, provavelmente, nem o leitor, nem nós, seremos ainda capazes de decifrar a tinta sumida dos papéis?”. Neste artigo mantenho que a codificação das fases de escrita no Livro do Desassossego permite representar o processo de composição textual que é interpretado de maneira diferente pelos especialistas. A especificidade da escrita pessoana presenta uma série de dificuldades que os especialistas enfrentam de forma diferente. Desta forma, a comparação entre o trabalho realizado com a edição crítica e o trabalho realizado com a codificação informática permite pôr em paralelo os problemas e soluções adotados em dois momentos diferenciados dos estudos pessoanos e dos estudos humanísticos em geral.
Nakamura, R.; Plaschke, F.; Teubenbacher, R.; Giner, L.; Baumjohann, W.; Magnes, W.; Steller, M.; Torbert, R. B.; Vaith, H.; Chutter, M.; Fornaçon, K.-H.; Glassmeier, K.-H.; Carr, C.
2013-07-01
We compare the magnetic field data obtained from the Flux-Gate Magnetometer (FGM) and the magnetic field data deduced from the gyration time of electrons measured by the Electron Drift Instrument (EDI) onboard Cluster to determine the spin axis offset of the FGM measurements. Data are used from orbits with their apogees in the magnetotail, when the magnetic field magnitude was between about 20 nT and 500 nT. Offset determination with the EDI-FGM comparison method is of particular interest for these orbits, because no data from solar wind are available in such orbits to apply the usual calibration methods using the Alfvén waves. In this paper, we examine the effects of the different measurement conditions, such as direction of the magnetic field relative to the spin plane and field magnitude in determining the FGM spin-axis offset, and also take into account the time-of-flight offset of the EDI measurements. It is shown that the method works best when the magnetic field magnitude is less than about 128 nT and when the magnetic field is aligned near the spin-axis direction. A remaining spin-axis offset of about 0.4 ~ 0.6 nT was observed between July and October 2003. Using multi-point multi-instrument measurements by Cluster we further demonstrate the importance of the accurate determination of the spin-axis offset when estimating the magnetic field gradient.
Nakamura, R.; Plaschke, F.; Teubenbacher, R.; Giner, L.; Baumjohann, W.; Magnes, W.; Steller, M.; Torbert, R. B.; Vaith, H.; Chutter, M.; Fornaçon, K.-H.; Glassmeier, K.-H.; Carr, C.
2014-01-01
We compare the magnetic field data obtained from the flux-gate magnetometer (FGM) and the magnetic field data deduced from the gyration time of electrons measured by the electron drift instrument (EDI) onboard Cluster to determine the spin-axis offset of the FGM measurements. Data are used from orbits with their apogees in the magnetotail, when the magnetic field magnitude was between about 20 and 500 nT. Offset determination with the EDI-FGM comparison method is of particular interest for these orbits, because no data from solar wind are available in such orbits to apply the usual calibration methods using the Alfvén waves. In this paper, we examine the effects of the different measurement conditions, such as direction of the magnetic field relative to the spin plane and field magnitude in determining the FGM spin-axis offset, and also take into account the time-of-flight offset of the EDI measurements. It is shown that the method works best when the magnetic field magnitude is less than about 128 nT and when the magnetic field is aligned near the spin-axis direction. A remaining spin-axis offset of about 0.4 ∼ 0.6 nT was observed for Cluster 1 between July and October 2003. Using multipoint multi-instrument measurements by Cluster we further demonstrate the importance of the accurate determination of the spin-axis offset when estimating the magnetic field gradient.
Kokerov, Margo, 1978-
2001-01-01
Eesti kaubaveo logistika elektroonilise andmevahetussüsteemi EDI (Electronic Data Interchange) projekti esimese etapina käivitub piiriületuse dokumentatsiooni ja kaubadeklaratsioonide elektroonilise esitamise võimalus. Toivo Jürgenson ja Jaan Pillesaar e-piiriületuse eelistest
Directory of Open Access Journals (Sweden)
Hilde Giezen
Full Text Available The Copenhagen Hip And Groin Outcome Score (HAGOS was developed to assess disease-specific consequences in young to middle-aged, physically active hip and/or groin patients. The study aimed to determine validity and reliability of the Dutch version of the HAGOS (HAGOS-NL for middle-aged patients with hip complaints.To assess validity, 117 participants completed five questionnaires: HAGOS-NL, international Hip Outcome Tool (iHOT-12NL, Hip disability and Osteoarthritis Outcome Score (HOOS, RAND-36 Health Survey and Tegner activity scale. Structural validity was determined by conducting confirmatory factor analysis. Construct validity was analyzed by formulating predefined hypotheses regarding relationships between the HAGOS-NL and subscales of the iHOT-12NL, HOOS, RAND-36 and Tegner activity scale. The HAGOS-NL was filled out again by 67 patients to explore test-retest reliability. Reliability was assessed in terms of Cronbach's alpha, Intraclass Correlation Coefficient (ICC, Standard Error of Measurement (SEM and Minimal Detectable Change (MDC. The Bland and Altman method was used to explore absolute agreement.Factor analysis confirmed that the HAGOS-NL consists of six subscales. All hypotheses were confirmed, indicating good construct validity. Internal consistency was good, with Cronbach's alpha values ranging from 0.89 to 0.98. Test-retest reliability was considered good, with ICC values of 0.80 and higher. The SEM ranged from 6.6 to 12.3, and MDC at individual level from 18.3 to 34.1 and at group level from 2.3 to 4.4. Bland and Altman analyses showed no bias.The HAGOS-NL is a reliable and valid instrument for measuring pain, physical functioning and quality of life in middle-aged patients with hip complaints.
Center-Within-Trial Versus Trial-Level Evaluation of Surrogate Endpoints
Renfro, Lindsay A.; Shi, Qian; Xue, Yuan; Li, Junlong; Shang, Hongwei; Sargent, Daniel J.
2014-01-01
Evaluation of candidate surrogate endpoints using individual patient data from multiple clinical trials is considered the gold standard approach to validate surrogates at both patient and trial levels. However, this approach assumes the availability of patient-level data from a relatively large collection of similar trials, which may not be possible to achieve for a given disease application. One common solution to the problem of too few similar trials involves performing trial-level surrogacy analyses on trial sub-units (e.g., centers within trials), thereby artificially increasing the trial-level sample size for feasibility of the multi-trial analysis. To date, the practical impact of treating trial sub-units (centers) identically to trials in multi-trial surrogacy analyses remains unexplored, and conditions under which this ad hoc solution may in fact be reasonable have not been identified. We perform a simulation study to identify such conditions, and demonstrate practical implications using a multi-trial dataset of patients with early stage colon cancer. PMID:25061255
Livros do Brasil e a edição de romances brasileiros em Portugal nos anos 1940
Directory of Open Access Journals (Sweden)
Thiago Mio Salla
2017-12-01
Full Text Available Enquanto esforço de historiografia literária e editorial, o presente artigo tem como objetivo lançar luz sobre as edições portuguesas de romances brasileiros realizadas pela editora Livros do Brasil, casa fundada em Lisboa, em 1944, por António de Sousa Pinto. A partir da recuperação de fontes primárias (com destaque para cartas e contratos, examinam-se, sobretudo, as negociações travadas entre Sousa Pinto e José Olympio no que diz respeito à edição, em Portugal, de títulos de dois importantes autores de nossa chamada geração de 1930: José Lins do Rego e Rachel de Queiroz. Mais especificamente, recupera-se o embate travado entre a atitude interventiva do editor luso, que defendia a necessidade de se ajustar o texto das obras de ambos os escritores à variante europeia do idioma, de modo a aproximá-las do leitorado português, e a recusa inicial dos romancistas, que exigiam o respeito estrito aos “brasileirismos” por eles empregados.
«Dos benefícios de Deus»: três edições de um capítulo do tratado medieval português
Directory of Open Access Journals (Sweden)
Rita de Cássia Ribeiro Queiroz
2010-12-01
Full Text Available Resumo: O tratado “Dos benefícios de Deus” integra a obra da literatura medieval portuguesa intitulada Castelo perigoso, a qual é uma adaptação do texto francês escrito por Frère Robert, monge cartuxo, à sua prima Soeur Rose, da Ordem Fontevrault. A versão em língua portuguesa foi realizada no Mosteiro de Alcobaça, provavelmente no século XV, existindo dois códices (ALC 197 e ALC 214, os quais se encontram na Biblioteca Nacional de Portugal. O tratado “Dos benefícios de Deus” é o segundo na ordem dos textos que compõem a obra Castelo perigoso. Propõem-se, neste trabalho, três edições de um capítulo do tratado“Dos benefícios de Deus”, a saber: uma edição conservadora ou semidiplomática; uma edição crítica, executada a partir da collatio entre os códices ALC 197 e ALC 214 e a edição realizada por Augusto Magne na década de 1940; e, por último, uma edição modernizada. Palavras-chave: Crítica textual; edição; português medieval. Résumé: Le traité “Dos benefícios de Deus” intègre l’oeuvre de la littérature médiévale potugaise Chastel périlleux, qui est une adaptation du texte français écrit par Robert Frère, moine chartreux, à sa cousine Soeur Rose, de l’Ordre Fontevrault. La version en langue portugaise a été réalisée au Monastère d’Alcobaça, probablement au XVe siècle: il y a deux codex (ALC 197 et ALC 214, qui sont à la Bibliothèque Nationale du Portugal. Le traité “Dos benefícios de Deus” est le deuxième dans l’ordre des textes qui constituent l’oeuvre Chastel périlleux. Sont proposées dans le présent travail trois éditions d’un chapitre du traité “Dos benefícios de Deus”, à savoir: une édition conservatrice ou semidiplomatique; une édition critique, faite à partir de la collation des manuscrits entre les codex 197 et 214 et l’édition faite par Augusto Magne en 1940; et, enfin, une édition modernisée. Mots-clés: Critique textuelle
Evaluating biomarkers for prognostic enrichment of clinical trials.
Kerr, Kathleen F; Roth, Jeremy; Zhu, Kehao; Thiessen-Philbrook, Heather; Meisner, Allison; Wilson, Francis Perry; Coca, Steven; Parikh, Chirag R
2017-12-01
A potential use of biomarkers is to assist in prognostic enrichment of clinical trials, where only patients at relatively higher risk for an outcome of interest are eligible for the trial. We investigated methods for evaluating biomarkers for prognostic enrichment. We identified five key considerations when considering a biomarker and a screening threshold for prognostic enrichment: (1) clinical trial sample size, (2) calendar time to enroll the trial, (3) total patient screening costs and the total per-patient trial costs, (4) generalizability of trial results, and (5) ethical evaluation of trial eligibility criteria. Items (1)-(3) are amenable to quantitative analysis. We developed the Biomarker Prognostic Enrichment Tool for evaluating biomarkers for prognostic enrichment at varying levels of screening stringency. We demonstrate that both modestly prognostic and strongly prognostic biomarkers can improve trial metrics using Biomarker Prognostic Enrichment Tool. Biomarker Prognostic Enrichment Tool is available as a webtool at http://prognosticenrichment.com and as a package for the R statistical computing platform. In some clinical settings, even biomarkers with modest prognostic performance can be useful for prognostic enrichment. In addition to the quantitative analysis provided by Biomarker Prognostic Enrichment Tool, investigators must consider the generalizability of trial results and evaluate the ethics of trial eligibility criteria.
Validation of the Dutch language version of the Safety Attitudes Questionnaire (SAQ-NL).
Haerkens, Marck Htm; van Leeuwen, Wouter; Sexton, J Bryan; Pickkers, Peter; van der Hoeven, Johannes G
2016-08-15
As the first objective of caring for patients is to do no harm, patient safety is a priority in delivering clinical care. An essential component of safe care in a clinical department is its safety climate. Safety climate correlates with safety-specific behaviour, injury rates, and accidents. Safety climate in healthcare can be assessed by the Safety Attitudes Questionnaire (SAQ), which provides insight by scoring six dimensions: Teamwork Climate, Job Satisfaction, Safety Climate, Stress Recognition, Working Conditions and Perceptions of Management. The objective of this study was to assess the psychometric properties of the Dutch language version of the SAQ in a variety of clinical departments in Dutch hospitals. The Dutch version (SAQ-NL) of the SAQ was back translated, and analyzed for semantic characteristics and content. From October 2010 to November 2015 SAQ-NL surveys were carried out in 17 departments in two university and seven large non-university teaching hospitals in the Netherlands, prior to a Crew Resource Management human factors intervention. Statistical analyses were used to examine response patterns, mean scores, correlations, internal consistency reliability and model fit. Cronbach's α's and inter-item correlations were calculated to examine internal consistency reliability. One thousand three hundred fourteen completed questionnaires were returned from 2113 administered to health care workers, resulting in a response rate of 62 %. Confirmatory Factor Analysis revealed the 6-factor structure fit the data adequately. Response patterns were similar for professional positions, departments, physicians and nurses, and university and non-university teaching hospitals. The SAQ-NL showed strong internal consistency (α = .87). Exploratory analysis revealed differences in scores on the SAQ dimensions when comparing different professional positions, when comparing physicians to nurses and when comparing university to non-university hospitals. The SAQ-NL
Human Coronaviruses 229E and NL63: Close Yet Still So Far
Dijkman, Ronald; van der Hoek, Lia
2009-01-01
HCoV-NL63 and HCoV-229E are two of the four human coronaviruses that circulate worldwide. These two viruses are unique in their relationship towards each other. Phylogenetically, the viruses are more closely related to each other than to any other human coronavirus, yet they only share 65% sequence
O Encheirídion de Epicteto: Edição Bilíngue
Directory of Open Access Journals (Sweden)
Aldo Lopes Dinucci
2012-02-01
Full Text Available Edição bilíngue do Encheirídion de Epicteto, obra do aluno de Epicteto (55-135 e cidadão romano de origem grega Lúcio Flávio Arriano de Nicomédia (86-160. Tal tradução, produzida por Aldo Dinucci (doutor em filosofia pela PUC-RJ e professor associado do Departamento de Filosofia da UFS e Alfredo Julien (doutor em história pela USP e professor adjunto do Departamento de História da UFS, foi financiada pelo CNPq (edital MCT/CNPq 02/2009 - Ciências Humanas, Sociais e Sociais Aplicadas.
CREATE-NL+: A robust control-oriented free boundary dynamic plasma equilibrium solver
International Nuclear Information System (INIS)
Albanese, R.; Ambrosino, R.; Mattei, M.
2015-01-01
CREATE-NL+ is a FEM (Finite Elements Method) solver of the free boundary dynamic plasma equilibrium problem, i.e. the MHD (Magneto Hydro Dynamics) time evolution of 2D axisymmetric plasmas in toroidal nuclear fusion devices, including eddy currents in the passive structures, and feedback control laws for current, position and shape control. This is an improved version of the CREATE-NL code developed in 2002 which was validated on JET and used for the design of the XSC (eXtreme Shape Controller), and for simulation studies on many existing and future tokamaks. A significant improvement was the use of a robust numerical scheme for the calculation of the Jacobian matrix within the Newton based scheme for the solution of the FEM nonlinear algebraic equations. The improved capability of interfacing with other codes, and a general decrease of the computational burden for the simulation of long pulses with small time steps makes this code a flexible tool for the design and testing of magnetic control in a tokamak.
CREATE-NL+: A robust control-oriented free boundary dynamic plasma equilibrium solver
Energy Technology Data Exchange (ETDEWEB)
Albanese, R. [Ass. EURATOM/ENEA/CREATE, Universita’ di Napoli “Federico II”, Naples (Italy); Ambrosino, R. [Ass. EURATOM/ENEA/CREATE, Universita’ di Napoli “Parthenope”, Naples (Italy); Mattei, M., E-mail: massimiliano.mattei@unina2.it [Ass. EURATOM/ENEA/CREATE, Seconda Universita’ di Napoli, Naples (Italy)
2015-10-15
CREATE-NL+ is a FEM (Finite Elements Method) solver of the free boundary dynamic plasma equilibrium problem, i.e. the MHD (Magneto Hydro Dynamics) time evolution of 2D axisymmetric plasmas in toroidal nuclear fusion devices, including eddy currents in the passive structures, and feedback control laws for current, position and shape control. This is an improved version of the CREATE-NL code developed in 2002 which was validated on JET and used for the design of the XSC (eXtreme Shape Controller), and for simulation studies on many existing and future tokamaks. A significant improvement was the use of a robust numerical scheme for the calculation of the Jacobian matrix within the Newton based scheme for the solution of the FEM nonlinear algebraic equations. The improved capability of interfacing with other codes, and a general decrease of the computational burden for the simulation of long pulses with small time steps makes this code a flexible tool for the design and testing of magnetic control in a tokamak.
Al-Khannaq, Maryam Nabiel; Ng, Kim Tien; Oong, Xiang Yong; Pang, Yong Kek; Takebe, Yutaka; Chook, Jack Bee; Hanafi, Nik Sherina; Kamarulzaman, Adeeba; Tee, Kok Keng
2016-05-04
The human alphacoronaviruses HCoV-NL63 and HCoV-229E are commonly associated with upper respiratory tract infections (URTI). Information on their molecular epidemiology and evolutionary dynamics in the tropical region of southeast Asia however is limited. Here, we analyzed the phylogenetic, temporal distribution, population history, and clinical manifestations among patients infected with HCoV-NL63 and HCoV-229E. Nasopharyngeal swabs were collected from 2,060 consenting adults presented with acute URTI symptoms in Kuala Lumpur, Malaysia, between 2012 and 2013. The presence of HCoV-NL63 and HCoV-229E was detected using multiplex polymerase chain reaction (PCR). The spike glycoprotein, nucleocapsid, and 1a genes were sequenced for phylogenetic reconstruction and Bayesian coalescent inference. A total of 68/2,060 (3.3%) subjects were positive for human alphacoronavirus; HCoV-NL63 and HCoV-229E were detected in 45 (2.2%) and 23 (1.1%) patients, respectively. A peak in the number of HCoV-NL63 infections was recorded between June and October 2012. Phylogenetic inference revealed that 62.8% of HCoV-NL63 infections belonged to genotype B, 37.2% was genotype C, while all HCoV-229E sequences were clustered within group 4. Molecular dating analysis indicated that the origin of HCoV-NL63 was dated to 1921, before it diverged into genotype A (1975), genotype B (1996), and genotype C (2003). The root of the HCoV-229E tree was dated to 1955, before it diverged into groups 1-4 between the 1970s and 1990s. The study described the seasonality, molecular diversity, and evolutionary dynamics of human alphacoronavirus infections in a tropical region. © The American Society of Tropical Medicine and Hygiene.
Distribution and ecotoxicity of chlorotriazines in the Scheldt Estuary (B-Nl)
International Nuclear Information System (INIS)
Noppe, Herlinde; Ghekiere, An; Verslycke, Tim; Wulf, Eric de; Verheyden, Karolien; Monteyne, Els; Polfliet, Karen; Caeter, Peter van; Janssen, Colin R.; Brabander, Hubert F. de
2007-01-01
As part of the Endis-Risks project, the current study describes the occurrence of the chlorotriazine pesticides atrazine, simazine and terbutylazine in water, sediment and suspended matter in the Scheldt estuary (B-Nl) from 2002 to 2005 (3 samplings a year, 8 sampling points). Atrazine was found at the highest concentrations, varying from 10 to 736 ng/l in water and from 5 up to 10 ng/g in suspended matter. Simazine and terbutylazine were detected at lower concentrations. Traces of the targeted pesticides were also detected in sediments, but these were below the limit of quantification. As part of an ecotoxicological assessment, we studied the potential effect of atrazine on molting of Neomysis integer (Crustacea:Mysidacea), a resident invertebrate of the Scheldt Estuary and a proposed test organism for the evaluation of endocrine disruption. Following chronic exposure (∼3 weeks), atrazine did not significantly affect mysid molting at environmentally relevant concentrations (up to 1 μg/l). - The water of the Scheldt estuary and its associated suspended solids are contaminated with chlorotriazines at concentrations that do not affect mysid molting
Bernardo Esteves Gonçalves da Costa; Carlos Frederico de Brito d'Andréa
2011-01-01
Este artigo tem como objetivo analisar e comparar a edição colaborativa de dois artigos sobre pandemia de gripe A (H1N1) — ou gripe suína — na Wikipédia em português. Monitoramos as edições feitas nos dois artigos ao longo de um mês após a criação de ambos, em 25 de abril de 2009. Caracterizamos o processo de edição dos textos e a dinâmica de interações entre os editores e, de forma complementar, analisamos seu conteúdo a partir de três critérios: autoridade, verificabilidade e atualidade....
Jimenez, Raul
2009-01-01
The recent weak lensing measurement of the dark matter mass of the high-redshift galaxy cluster XMMUJ2235.3-2557 of (8.5 +- 1.7) x 10^{14} Msun at z=1.4, indicates that, if the cluster is assumed to be the result of the collapse of dark matter in a primordial gaussian field in the standard LCDM model, then its abundance should be 3-10 if the non-Gaussianity parameter f^local_NL is in the range 150-200. This value is comparable to the limit for f_NL obtained by current constraints from the CMB. We conclude that mass determination of high-redshift, massive clusters can offer a complementary probe of primordial non-gaussianity.
Solid oxide fuel cell field trial evaluation
Energy Technology Data Exchange (ETDEWEB)
Wilcox, C.P.; Winstanley, R.; Nietsch, T.; Smith, C.; Knight, R.; Seymore, C.
2000-07-01
This report focuses on issues relating to a field trial of a solid oxide fuel cell (SOFC). Aspects examined include markets for SOFC systems, the choice of systems for demonstration in year 2002, the assessment of industrial interest, and evaluation and ranking of candidate systems. The identification and evaluation of interest in field trials, the estimation of the capital and running costs of a field trial, and identification of the benefits to the UK and barriers to implementation of SOFC systems are discussed. (UK)
Named Entity Recognition in a Hungarian NL Based QA System
Tikkl, Domonkos; Szidarovszky, P. Ferenc; Kardkovacs, Zsolt T.; Magyar, Gábor
In WoW project our purpose is to create a complex search interface with the following features: search in the deep web content of contracted partners' databases, processing Hungarian natural language (NL) questions and transforming them to SQL queries for database access, image search supported by a visual thesaurus that describes in a structural form the visual content of images (also in Hungarian). This paper primarily focuses on a particular problem of question processing task: the entity recognition. Before going into details we give a short overview of the project's aims.
Rietdijk, J.; Dragt, S.; Klaassen, R.; Ising, H; Nieman, D.; Wunderink, L.; Delespaul, P.; Cuijpers, P.; Linszen, D.; van der Gaag, M.
2010-01-01
Background: Psychotic disorders are a serious mental health problem. Intervention before the onset of psychosis might result in delaying the onset, reducing the impact or even preventing the first episode of psychosis. This study explores the effectiveness of cognitive behavioural therapy (CBT) in
Tekenradar.nl: een webplatform voor wetenschappelijk onderzoek naar tekenbeten en de ziekte van Lyme
Wijngaard, van den C.C.; Vliet, van A.J.H.; Vrijmoeth, H.D.; Ursinus, J.; Harms, Margriet
2016-01-01
Tekenradar.nl is een webplatform voor onderzoek naar teken en tekenoverdraagbare aandoeningen zoals de ziekte van Lyme. Het RIVM en Wageningen University hebben de website in 2012 gezamenlijk opgericht. De website geeft informatie over tekenbeten en de ziekte van Lyme en een voorspelling van de
Choroidal Thickness Analysis in Patients with Usher Syndrome Type 2 Using EDI OCT
Directory of Open Access Journals (Sweden)
L. Colombo
2015-01-01
Full Text Available To portray Usher Syndrome type 2, analyzing choroidal thickness and comparing data reported in published literature on RP and healthy subjects. Methods. 20 eyes of 10 patients with clinical signs and genetic diagnosis of Usher Syndrome type 2. Each patient underwent a complete ophthalmologic examination including Best Corrected Visual Acuity (BCVA, intraocular pressure (IOP, axial length (AL, automated visual field (VF, and EDI OCT. Both retinal and choroidal measures were measured. Statistical analysis was performed to correlate choroidal thickness with age, BCVA, IOP, AL, VF, and RT. Comparison with data about healthy people and nonsyndromic RP patients was performed. Results. Mean subfoveal choroidal thickness (SFCT was 248.21±79.88 microns. SFCT was statistically significant correlated with age (correlation coefficient −0.7248179, p<0.01. No statistically significant correlation was found between SFCT and BCVA, IOP, AL, VF, and RT. SFCT was reduced if compared to healthy subjects (p<0.01. No difference was found when compared to choroidal thickness from nonsyndromic RP patients (p=0.2138. Conclusions. Our study demonstrated in vivo choroidal thickness reduction in patients with Usher Syndrome type 2. These data are important for the comprehension of mechanisms of disease and for the evaluation of therapeutic approaches.
Klimaatneutraal in de praktijk : ervaringen en resultaten van de deelnemers van BoerenKlimaat.nl
Dubbeldam, R.; Wijnands, F.G.; Asperen, van P.; Monteny, A.
2013-01-01
De huidige landbouw draagt bij aan het broeikaseffect en daarmee aan de klimaatverandering. Tegelijk heeft de landbouw goede mogelijkheden om de broeikasgasemissies te verminderen. Zestien agrariërs laten in het project BoerenKlimaat.nl samen met Wageningen UR en het Louis Bolk Instituut zien hoe
Bouman, Zita; Hendriks, Marc P H; Van Der Veld, William M; Aldenkamp, Albert P; Kessels, Roy P C
2016-06-01
The reliability and validity of three short forms of the Dutch version of the Wechsler Memory Scale-Fourth Edition (WMS-IV-NL) were evaluated in a mixed clinical sample of 235 patients. The short forms were based on the WMS-IV Flexible Approach, that is, a 3-subtest combination (Older Adult Battery for Adults) and two 2-subtest combinations (Logical Memory and Visual Reproduction and Logical Memory and Designs), which can be used to estimate the Immediate, Delayed, Auditory and Visual Memory Indices. All short forms showed good reliability coefficients. As expected, for adults (16-69 years old) the 3-subtest short form was consistently more accurate (predictive accuracy ranged from 73% to 100%) than both 2-subtest short forms (range = 61%-80%). Furthermore, for older adults (65-90 years old), the predictive accuracy of the 2-subtest short form ranged from 75% to 100%. These results suggest that caution is warranted when using the WMS-IV-NL Flexible Approach short forms to estimate all four indices. © The Author(s) 2015.
A ansiedade da unidade: uma teoria da edição / L’ansia di unità: Una teoria dell’edizione
Directory of Open Access Journals (Sweden)
Jerónimo Pizarro
2016-12-01
Full Text Available Em 1973 Harold Bloom publicou o livro The Anxiety of Influence: A Theory of Poetry. Uma variação sobre este título poderá ser-nos hoje útil para abordar um outro tipo de ansiedade: o da unidade. Os campos da edição e da interpretação vivem imersos nesse outro tipo de ansiedade. Tanto a interpretação, preocupada com a intenção do autor, da obra ou do leitor, como a edição, angustiada com as intenções finais do autor e o estabelecimento do copy-text, parecem, por vezes, pouco capazes de se libertarem desse ensejo de unidade e de se adaptarem à existência da multiplicidade. Neste artigo, procuro fazer um novo apelo a uma necessária mudança de paradigma, atendendo, em especial, às novas e libertadoras possibilidades potenciadas pela edição electrónica. In 1973 Harold Bloom published his book The Anxiety of Influence: A Theory of Poetry. A variation on this title might be useful for us today to refer to another kind of anxiety: the anxiety of unity. The fields of editing and interpretation lie within this other kind of anxiety. Interpretation, concerned with the author’s, the reader’s or the work’s intention, and editing, worried about the author’s final intentions and the setting up of the copy-text, seem, at times, unable to free themselves from the need to attain unity and adapt to the existence of multiplicity. In this article I intend to make a new appeal on behalf of a change of paradigm, addressing, especially, the new and liberating possibilities of electronic editing
Krikke, M; Hoogeveen, R C; Hoepelman, A I M; Visseren, F L J; Arends, J E
2016-04-01
The aim of the study was to compare the predictions of five popular cardiovascular disease (CVD) risk prediction models, namely the Data Collection on Adverse Events of Anti-HIV Drugs (D:A:D) model, the Framingham Heart Study (FHS) coronary heart disease (FHS-CHD) and general CVD (FHS-CVD) models, the American Heart Association (AHA) atherosclerotic cardiovascular disease risk score (ASCVD) model and the Systematic Coronary Risk Evaluation for the Netherlands (SCORE-NL) model. A cross-sectional design was used to compare the cumulative CVD risk predictions of the models. Furthermore, the predictions of the general CVD models were compared with those of the HIV-specific D:A:D model using three categories ( 20%) to categorize the risk and to determine the degree to which patients were categorized similarly or in a higher/lower category. A total of 997 HIV-infected patients were included in the study: 81% were male and they had a median age of 46 [interquartile range (IQR) 40-52] years, a known duration of HIV infection of 6.8 (IQR 3.7-10.9) years, and a median time on ART of 6.4 (IQR 3.0-11.5) years. The D:A:D, ASCVD and SCORE-NL models gave a lower cumulative CVD risk, compared with that of the FHS-CVD and FHS-CHD models. Comparing the general CVD models with the D:A:D model, the FHS-CVD and FHS-CHD models only classified 65% and 79% of patients, respectively, in the same category as did the D:A:D model. However, for the ASCVD and SCORE-NL models, this percentage was 89% and 87%, respectively. Furthermore, FHS-CVD and FHS-CHD attributed a higher CVD risk to 33% and 16% of patients, respectively, while this percentage was D:A:D, ASCVD and SCORE-NL models. This could have consequences regarding overtreatment, drug-related adverse events and drug-drug interactions. © 2015 British HIV Association.
Developments in statistical evaluation of clinical trials
Oud, Johan; Ghidey, Wendimagegn
2014-01-01
This book describes various ways of approaching and interpreting the data produced by clinical trial studies, with a special emphasis on the essential role that biostatistics plays in clinical trials. Over the past few decades the role of statistics in the evaluation and interpretation of clinical data has become of paramount importance. As a result the standards of clinical study design, conduct and interpretation have undergone substantial improvement. The book includes 18 carefully reviewed chapters on recent developments in clinical trials and their statistical evaluation, with each chapter providing one or more examples involving typical data sets, enabling readers to apply the proposed procedures. The chapters employ a uniform style to enhance comparability between the approaches.
Förster, Matthias; Rashev, Mikhail; Haaland, Stein
2017-04-01
The Electron Drift Instrument (EDI) onboard Cluster can measure 500 eV and 1 keV electron fluxes with high time resolution during passive operation phases in its Ambient Electron (AE) mode. Data from this mode is available in the Cluster Science Archive since October 2004 with a cadence of 16 Hz in the normal mode or 128 Hz for burst mode telemetry intervals. The fluxes are recorded at pitch angles of 0, 90, and 180 degrees. This paper describes the calibration and validation of these measurements. The high resolution AE data allow precise temporal and spatial diagnostics of magnetospheric boundaries and will be used for case studies and statistical studies of low energy electron fluxes in the near-Earth space. We show examples of applications.
Evidence supporting a zoonotic origin of human coronavirus strain NL63.
Huynh, Jeremy; Li, Shimena; Yount, Boyd; Smith, Alexander; Sturges, Leslie; Olsen, John C; Nagel, Juliet; Johnson, Joshua B; Agnihothram, Sudhakar; Gates, J Edward; Frieman, Matthew B; Baric, Ralph S; Donaldson, Eric F
2012-12-01
The relationship between bats and coronaviruses (CoVs) has received considerable attention since the severe acute respiratory syndrome (SARS)-like CoV was identified in the Chinese horseshoe bat (Rhinolophidae) in 2005. Since then, several bats throughout the world have been shown to shed CoV sequences, and presumably CoVs, in the feces; however, no bat CoVs have been isolated from nature. Moreover, there are very few bat cell lines or reagents available for investigating CoV replication in bat cells or for isolating bat CoVs adapted to specific bat species. Here, we show by molecular clock analysis that alphacoronavirus (α-CoV) sequences derived from the North American tricolored bat (Perimyotis subflavus) are predicted to share common ancestry with human CoV (HCoV)-NL63, with the most recent common ancestor between these viruses occurring approximately 563 to 822 years ago. Further, we developed immortalized bat cell lines from the lungs of this bat species to determine if these cells were capable of supporting infection with HCoVs. While SARS-CoV, mouse-adapted SARS-CoV (MA15), and chimeric SARS-CoVs bearing the spike genes of early human strains replicated inefficiently, HCoV-NL63 replicated for multiple passages in the immortalized lung cells from this bat species. These observations support the hypothesis that human CoVs are capable of establishing zoonotic-reverse zoonotic transmission cycles that may allow some CoVs to readily circulate and exchange genetic material between strains found in bats and other mammals, including humans.
Fen Bilgisi Öğretmen Adaylarının Kimya Bilgilerini Günlük Hayatla İlişkilendirebilme Düzeyleri
Yadigaroğlu, Yrd. Doç. Dr. Mustafa; DEMİRCİOĞLU, Doç. Dr. Gökhan; DEMİRCİOĞLU, Doç. Dr. Hülya
2017-01-01
Fen eğitiminin temel amaçlarındanbiri, öğrencilerin fen okur-yazarı olmalarını sağlayarak onları günlükyaşantılarında karşılaştıkları fen olaylarına anlam vermelerine yardımcıolmaktır. Günlük hayatla ya da bağlamı ile ilişkilendirilmeyen bilgi öğrencininzihninde her zaman eksik olacaktır. Bunun gerçekleştirilmesinde fen dersleriiçerisinde yer alan kimya önemli bir yere sahiptir. Bu düşünceden hareketleçalışmada, fen bilgisi öğretmen adaylarının kimya bilgilerini günlük hayatlailişkilendirebil...
Cross-system evaluation of clinical trial search engines.
Jiang, Silis Y; Weng, Chunhua
2014-01-01
Clinical trials are fundamental to the advancement of medicine but constantly face recruitment difficulties. Various clinical trial search engines have been designed to help health consumers identify trials for which they may be eligible. Unfortunately, knowledge of the usefulness and usability of their designs remains scarce. In this study, we used mixed methods, including time-motion analysis, think-aloud protocol, and survey, to evaluate five popular clinical trial search engines with 11 users. Differences in user preferences and time spent on each system were observed and correlated with user characteristics. In general, searching for applicable trials using these systems is a cognitively demanding task. Our results show that user perceptions of these systems are multifactorial. The survey indicated eTACTS being the generally preferred system, but this finding did not persist among all mixed methods. This study confirms the value of mixed-methods for a comprehensive system evaluation. Future system designers must be aware that different users groups expect different functionalities.
Interhemispheric differences in ionospheric convection: Cluster EDI observations revisited
Förster, M.; Haaland, S.
2015-07-01
The interaction between the interplanetary magnetic field and the geomagnetic field sets up a large-scale circulation in the magnetosphere. This circulation is also reflected in the magnetically connected ionosphere. In this paper, we present a study of ionospheric convection based on Cluster Electron Drift Instrument (EDI) satellite measurements covering both hemispheres and obtained over a full solar cycle. The results from this study show that average flow patterns and polar cap potentials for a given orientation of the interplanetary magnetic field can be very different in the two hemispheres. In particular during southward directed interplanetary magnetic field conditions, and thus enhanced energy input from the solar wind, the measurements show that the southern polar cap has a higher cross polar cap potential. There are persistent north-south asymmetries, which cannot easily be explained by the influence of external drivers. These persistent asymmetries are primarily a result of the significant differences in the strength and configuration of the geomagnetic field between the Northern and Southern Hemispheres. Since the ionosphere is magnetically connected to the magnetosphere, this difference will also be reflected in the magnetosphere in the form of different feedback from the two hemispheres. Consequently, local ionospheric conditions and the geomagnetic field configuration are important for north-south asymmetries in large regions of geospace.
Hao, Peiying; Lu, Chaofeng; Ma, Yan; Xu, Lingbo; Zhu, Jiajun; Yu, Xiaoping
2015-01-01
AKT-interacting protein (AKTIP) interacts with serine/threonine protein kinase B (PKB)/AKT. AKTIP modulates AKT’s activity by enhancing the phosphorylation of the regulatory site and plays a crucial role in multiple biological processes. In this study, the full length cDNA of NlAKTIP, a novel AKTIP gene in the brown planthopper (BPH) Nilaparvata lugens, was cloned. The reverse transcription quantitive PCR (RT-qPCR) results showed that the NlAKTIP gene was strongly expressed in gravid female adults, but was relatively weakly expressed in nymphs and male adult BPH. In female BPH, treatment with dsAKTIP resulted in the efficient silencing of NlAKTIP, leading to a significant reduction of mRNA levels, about 50% of those of the untreated control group at day 7 of the study. BPH fed with dsAKTIP had reduced growth with lower body weights and smaller sizes, and the body weight of BPH treated with dsAKTIP at day 7 decreased to about 30% of that of the untreated control. Treatment of dsAKTIP significantly delayed the eclosion for over 7 days relative to the control group and restricted ovarian development to Grade I (transparent stage), whereas the controls developed to Grade IV (matured stage). These results indicated that NlAKTIP is crucial to the growth and development of female BPH. This study provided a valuable clue of a potential target NlAKTIP for inhibiting the BPH, and also provided a new point of view on the interaction between BPH and resistant rice. PMID:26402675
Timely and complete publication of economic evaluations alongside randomized controlled trials.
Thorn, Joanna C; Noble, Sian M; Hollingworth, William
2013-01-01
Little is known about the extent and nature of publication bias in economic evaluations. Our objective was to determine whether economic evaluations are subject to publication bias by considering whether economic data are as likely to be reported, and reported as promptly, as effectiveness data. Trials that intended to conduct an economic analysis and ended before 2008 were identified in the International Standard Randomised Controlled Trial Number (ISRCTN) register; a random sample of 100 trials was retrieved. Fifty comparator trials were randomly drawn from those not identified as intending to conduct an economic study. The trial start and end dates, estimated sample size and funder type were extracted. For trials planning economic evaluations, effectiveness and economic publications were sought; publication dates and journal impact factors were extracted. Effectiveness abstracts were assessed for whether they reached a firm conclusion that one intervention was most effective. Primary investigators were contacted about reasons for non-publication of results, or reasons for differential publication strategies for effectiveness and economic results. Trials planning an economic study were more likely to be funded by government (p = 0.01) and larger (p = 0.003) than other trials. The trials planning an economic evaluation had a mean of 6.5 (range 2.7-13.2) years since the trial end in which to publish their results. Effectiveness results were reported by 70 %, while only 43 % published economic evaluations (p economic results included the intervention being ineffective, and staffing issues. Funding source, time since trial end and length of study were not associated with a higher probability of publishing the economic evaluation. However, studies that were small or of unknown size were significantly less likely to publish economic evaluations than large studies (p journal impact factor was 1.6 points higher for effectiveness publications than for the
Evaluation Using Sequential Trials Methods.
Cohen, Mark E.; Ralls, Stephen A.
1986-01-01
Although dental school faculty as well as practitioners are interested in evaluating products and procedures used in clinical practice, research design and statistical analysis can sometimes pose problems. Sequential trials methods provide an analytical structure that is both easy to use and statistically valid. (Author/MLW)
How to Assist Formalization of NL Regulations: Lessons from Business Rules Acquisition Experiments
Nazarenko , Adeline
2013-01-01
International audience; Decision systems usually rely on a set of business rules that describe the expected behavior of a system or an organization and that determine the decisions to be taken in different situations. However, rule acquisition is often the bottleneck that hinders the development of decision systems. When these rules are based on regulations written in Natural Language (NL), one solution is to derive formal business rules from the source documents. This approach also allows ch...
van Holland, Berry J; de Boer, Michiel R; Brouwer, Sandra; Soer, Remko; Reneman, Michiel F
2012-11-20
Sustained employability and health are generating awareness of employers in an aging and more complex work force. To meet these needs, employers may offer their employees health surveillance programs, to increase opportunities to work on health and sustained employability. However, evidence for these health surveillance programs is lacking. The FLESH study (Functional Labour Evaluation for Sustained Health and employment) was developed to evaluate a comprehensive workers' health promotion program on its effectiveness, cost-benefit, and process of the intervention. The study is designed as a cluster randomised stepped wedge trial with randomisation at company plant level and is carried out in a large meat processing company. Every contracted employee is offered the opportunity to participate in the POSE program (Promotion Of Sustained Employability). The main goals of the POSE program are 1) providing employee's insight into their current employability and health status, 2) offering opportunities to improve employability and decrease health risks and 3) improving employability and health sustainably in order to keep them healthy at work. The program consists of a broad assessment followed by a counselling session and, if needed, a tailored intervention. Measurements will be performed at baseline and will be followed up at 20, 40, 60, 80, 106 and 132 weeks. The primary outcome measures are work ability, productivity and absenteeism. Secondary outcomes include health status, vitality, and psychosocial workload. A cost-benefit study will be conducted from the employers' perspective. A process evaluation will be conducted and the satisfaction of employer and employees with the program will be assessed. This study provides information on the effectiveness of the POSE program on sustained employment. When the program proves to be effective, employees benefit by improved work ability, and health. Employers benefit from healthier employees, reduced sick leave (costs) and
Directory of Open Access Journals (Sweden)
van Holland Berry J
2012-11-01
Full Text Available Abstract Background Sustained employability and health are generating awareness of employers in an aging and more complex work force. To meet these needs, employers may offer their employees health surveillance programs, to increase opportunities to work on health and sustained employability. However, evidence for these health surveillance programs is lacking. The FLESH study (Functional Labour Evaluation for Sustained Health and employment was developed to evaluate a comprehensive workers’ health promotion program on its effectiveness, cost-benefit, and process of the intervention. Methods The study is designed as a cluster randomised stepped wedge trial with randomisation at company plant level and is carried out in a large meat processing company. Every contracted employee is offered the opportunity to participate in the POSE program (Promotion Of Sustained Employability. The main goals of the POSE program are 1 providing employee’s insight into their current employability and health status, 2 offering opportunities to improve employability and decrease health risks and 3 improving employability and health sustainably in order to keep them healthy at work. The program consists of a broad assessment followed by a counselling session and, if needed, a tailored intervention. Measurements will be performed at baseline and will be followed up at 20, 40, 60, 80, 106 and 132 weeks. The primary outcome measures are work ability, productivity and absenteeism. Secondary outcomes include health status, vitality, and psychosocial workload. A cost-benefit study will be conducted from the employers’ perspective. A process evaluation will be conducted and the satisfaction of employer and employees with the program will be assessed. Discussion This study provides information on the effectiveness of the POSE program on sustained employment. When the program proves to be effective, employees benefit by improved work ability, and health. Employers benefit
Mossman, Douglas; Wygant, Dustin B; Gervais, Roger O; Hart, Kathleen J
2018-01-01
This study examines the accuracy of the Test of Memory Malingering (TOMM), a frequently administered measure for evaluating effort during neurocognitive testing. In the last few years, several authors have suggested that the initial recognition trial of the TOMM (Trial 1) might be a more useful index for detecting feigned or exaggerated impairment than Trial 2, which is the source for inference recommended by the original instruction manual (Tombaugh, 1996). We used latent class modeling (LCM) implemented in a Bayesian framework to evaluate archival Trial 1 and Trial 2 data collected from 1,198 adults who had undergone outpatient forensic evaluations. All subjects were tested with 2 other performance validity tests (the Word Memory Test and the Computerized Assessment of Response Bias), and for 70% of the subjects, data from the California Verbal Learning Test-Second Edition Forced Choice trial were also available. Our results suggest that not even a perfect score on Trial 1 or Trial 2 justifies saying that an evaluee is definitely responding genuinely, although such scores imply a lower-than-base-rate probability of feigning. If one uses a Trial 2 cut-off higher than the manual's recommendation, Trial 2 does better than Trial 1 at identifying individuals who are almost certainly feigning while maintaining a negligible false positive rate. Using scores from both trials, one can identify a group of definitely feigning and very likely feigning subjects who comprise about 2 thirds of all feigners; only 1% of the members of this group would not be feigning. (PsycINFO Database Record (c) 2018 APA, all rights reserved).
Temporal stability of the Dutch version of the Wechsler Memory Scale - Fourth Edition (WMS-IV-NL)
Bouman, Z.; Hendriks, M.P.H.; Aldenkamp, A.P.; Kessels, R.P.C.
2015-01-01
Objective: The Wechsler Memory Scale - Fourth Edition (WMS-IV) is one of the most widely used memory batteries. We examined the test–retest reliability, practice effects, and standardized regression-based (SRB) change norms for the Dutch version of the WMS-IV (WMS-IV-NL) after both short and long
Espí-López, Gemma Victoria; Ruescas-Nicolau, Maria-Arantzazu; Sanchez-Sanchez, M Luz; Arnal-Gómez, Anna; Balasch-Bernat, Mercè; Marques-Sule, Elena
2018-02-10
Context • Thoracic manipulation decreases pain and disability. However, when such manipulation is contraindicated, the use of other manual techniques based on the regional interdependence of the thoracic spine, upper ribs, and shoulders is an alternative approach. Objective • The study intended to investigate the immediate changes resulting from 3 manual therapy treatments on spinal mobility, flexibility, comfort, and pain perception in patients with persistent, nonspecific back pain as well as changes in their sense of physical well-being and their perception of change after treatment. Design • The study was a randomized, double-blind, controlled trial. Setting • The study took place in the Department of Physiotherapy of the Faculty of Physiotherapy at the University of Valencia (Valencia, Spain). Participants • Participants were 112 individuals from the community-56.6% female, with a mean age of 21.8 ± 0.2 y-who had persistent, nonspecific back pain. Intervention • Participants were randomly assigned to 1 of 3 groups, receiving (1) neurolymphatic therapy (NL group), (2) articulatory spinal manual therapy (AS group), or (3) articulatory costal manual therapy (AC group). Outcome Measures • Cervical mobility, lumbar flexibility, comfort, pain perception, and physical well-being were assessed at baseline and immediately postintervention. Perception of change was evaluated postintervention. Results • Between baseline and postintervention, the AC group showed a significant increase in cervical flexion (P = .010), whereas the NL and AS groups improved in lumbar flexibility, P = .047 and P = .012, respectively. For that period, significant changes were found in lumbar comfort for the AS group (P < .001) and the NL group (P < .026) and in thoracic comfort (P < .001) for the AC group. All groups improved in physical well-being and pain perception (P < .05). Changes in thoracic comfort, lumbar comfort, and physical well-being differed among the groups, with
Alberta Learning: Early Development Instrument Pilot Project Evaluation.
Meaney, Wanda; Harris-Lorenze, Elayne
The Early Development Instrument (EDI) was designed by McMaster University to measure the outcomes of childrens early years as they influence their readiness to learn at school. The EDI was piloted in several Canadian cities in recent years through two national initiatives. Building on these initiatives, Alberta Learning piloted the EDI as a…
Energy Technology Data Exchange (ETDEWEB)
Ulke, Bernd [RWE Technology GmbH, Eemshaven (Netherlands). Bauleitung STKW; Boerg, Bernd [Tiefbau GmbH Unterweser (TAGU), Oldenburg (Germany)
2011-04-15
RWE Eemshaven Holding B.V. is currently constructing a coal power plant with seawater cooling at Eemshaven (NL). The main coolant line will go under the dam and necessitates construction of a cooling water outlet structure, which is described in the article. The work done until December 2009, including construction of the first underwater concrete floor, was described in an earlier article (Bautechnik 87 (2010), pp. 294-297). (orig.)
Ge, LinQuan; Gu, HaoTian; Huang, Bo; Song, Qisheng; Stanley, David; Liu, Fang; Yang, Guo-Qing; Wu, Jin-Cai
2017-01-01
The cAMP/PKA intracellular signaling pathway is launched by adenylyl cyclase (AC) conversion of adenosine triphosphate (ATP) to 3', 5'-cyclic AMP (cAMP) and cAMP-dependent activation of PKA. Although this pathway is very well known in insect physiology, there is little to no information on it in some very small pest insects, such as the brown planthopper (BPH), Nilaparvata lugens Stål. BPH is a destructive pest responsible for tremendous crop losses in rice cropping systems. We are investigating the potentials of novel pest management technologies from RNA interference perspective. Based on analysis of transcriptomic data, the BPH AC like-9 gene (NlAC9) was up-regulated in post-mating females, which led us to pose the hypothesis that NlAC9 is a target gene that would lead to reduced BPH fitness and populations. Targeting NlAC9 led to substantially decreased soluble ovarian protein content, yeast-like symbiont abundance, and vitellogenin gene expression, accompanied with stunted ovarian development and body size. Eggs laid were decreased and oviposition period shortened. Taken together, our findings indicated that NlAC9 exerted pronounced effects on female fecundity, growth and longevity, which strongly supports our hypothesis.
Directory of Open Access Journals (Sweden)
LinQuan Ge
Full Text Available The cAMP/PKA intracellular signaling pathway is launched by adenylyl cyclase (AC conversion of adenosine triphosphate (ATP to 3', 5'-cyclic AMP (cAMP and cAMP-dependent activation of PKA. Although this pathway is very well known in insect physiology, there is little to no information on it in some very small pest insects, such as the brown planthopper (BPH, Nilaparvata lugens Stål. BPH is a destructive pest responsible for tremendous crop losses in rice cropping systems. We are investigating the potentials of novel pest management technologies from RNA interference perspective. Based on analysis of transcriptomic data, the BPH AC like-9 gene (NlAC9 was up-regulated in post-mating females, which led us to pose the hypothesis that NlAC9 is a target gene that would lead to reduced BPH fitness and populations. Targeting NlAC9 led to substantially decreased soluble ovarian protein content, yeast-like symbiont abundance, and vitellogenin gene expression, accompanied with stunted ovarian development and body size. Eggs laid were decreased and oviposition period shortened. Taken together, our findings indicated that NlAC9 exerted pronounced effects on female fecundity, growth and longevity, which strongly supports our hypothesis.
Edição Temática “Cidades inteligentes: planejamento e gestão da sustentabilidade”
Cláudia Terezinha Kniess
2016-01-01
É com satisfação que apresentamos a edição temática da revista Gestão e Secretariado – Revista GeSec - com foco em “Cidades inteligentes: planejamento e gestão da sustentabilidade”. Os estudos nesta temática respondem a uma forte demanda da sociedade para o enfrentamento dos desafios atuais relacionados à crescente concentração da população nos centros urbanos e à diversidade de problemas técnicos e políticos relacionados a esta dinâmica. A revista GeSeC é classificada como Qualis B...
Energy Technology Data Exchange (ETDEWEB)
Cao, Qianlin; Wang, Jingdong; Cao, Jianping; Yang, Hongying [Medical College of Soochow University/Collaborative Innovation Center of Radiation Medicine of Jiangsu Higher Education Institutions, School of Radiation Medicine and Protection, Suzhou, Jiangsu (China); Liu, Wei [Soochow University, Department of Radiotherapy and Oncology, Second Affiliated Hospital, Suzhou, Jiangsu (China)
2018-03-15
Space radiation cancer risk may be a potential obstacle for long-duration spaceflight. Among all types of cancer space radiation may induce, lung cancer has been estimated to be the largest potential risk. Although previous animal study has shown that Fe ions, the most important contributor to the total dose equivalent of space radiation, induced a higher incidence of lung tumorigenesis per dose than X-rays, the underlying mechanisms at cellular level remained unclear. Therefore, in the present study, we investigated long-term biological changes in NL20 human bronchial epithelial cells after exposure to Fe ion or X-ray irradiation. We found that compared with sham control, the progeny of NL20 cells irradiated with 0.1 Gy of Fe ions showed slightly increased micronucleus formation, significantly decreased cell proliferation, disturbed cell cycle distribution, and obviously elevated intracellular ROS levels accompanied by reduced SOD1 and SOD2 expression, but the progeny of NL20 cells irradiated with 0.9 Gy of X-rays did not show any significant changes. More importantly, Fe ion exposure caused much greater soft-agar colony formation than X-rays did in the progeny of irradiated NL20 cells, clearly suggesting higher cell transformation potential of Fe ions compared with X-rays. These data may shed the light on the potential lung tumorigenesis risk from Fe ion exposure. In addition, ATM inhibition by Ku55933 reversed some of the changes in the progeny of Fe ion-irradiated cells but not others such as soft-agar colony formation, suggesting complex processes from DNA damage to carcinogenesis. These data indicate that even a single low dose of Fe ions can induce long-term biological responses such as cell transformation, etc., suggesting unignorable health risk from space radiation to astronauts. (orig.)
Fabrication of a cantilever-based microfluidic flow meter with nL min(-1) resolution
DEFF Research Database (Denmark)
Noeth, Nadine-Nicole; Keller, Stephan Sylvest; Boisen, Anja
2011-01-01
A microfluidic flow meter based on cantilever deflection is developed, showing a resolution down to 3 nL min(-1) for flows in the microliter range. The cantilevers are fabricated in SU-8 and have integrated holes with dimensions from 5 x 5 to20x 20 mu m(2). The holes make it possible to measure i......, hole-to-hole distance, amount of holes, etc) the sensitivity of the sensor can be changed....
Um 13 de maio antecipado: edições temáticas, atualidade e memória no circuito TRIP e TPM
Directory of Open Access Journals (Sweden)
Frederico de Mello Brandão Tavares
2016-05-01
Full Text Available Em abril de 2014, as revistas brasileiras TRIP e TPM publicaram uma edição temática, sob o mesmo título base – “Ser negro/negra no Brasil é f*da”, e estabeleceram um diálogo editorial a partir de um gancho temporal: o dia 13 de maio, quando se comemora a abolição da escravatura no país. Com um mês de antecedência e a partir de coberturas estruturadas por conteúdos específicos, em contato ou não, as publicações anteciparam o acontecimento, previsto, encerrando-o em uma “totalidade” de pautas, acionada por seções e provocadora de um circuito que, antes do “acontecer do acontecimento”, atualizou-o como temática, indicando seus sentidos. Neste contexto, o presente artigo observa relações existentes em acionamentos acontecimentais no jornalismo, mesmo quando estes não partem de uma cobertura factual. Tendo como objeto as edições de TRIP e TPM indicadas, busca-se percorrer a transversalidade originada pela tematização das revistas e compreender as afetações e/ou “determinações” que nela aparecem.
International Nuclear Information System (INIS)
Gomonaj, A.N.; Imre, A.I.
2005-01-01
Radiation transitions between 4d 9 ( 2 D 5/2,3/2 )5s 2 nl and 4d 10 5p( 2 P 1/2,3/2 0 )nl self-ionized states of Cd atom being dielectron satellites of λ325.0 nm (4d 9 5s 22 D 3/2 →4d 10 5p 2 P 1/2 0 ) and λ353.6 nm (4d 9 5s 22 D 3/2 → 4d 10 5p 2 P 3/2 0 ) laser lines of Cd + ion were detected for the first time at electron-ion collisions. One studied energy dependences of the effective cross sections of electron excitation of the satellite lines within 7-10 eV energy range. The effective cross sections of excitation of dielectron satellites constitutes ∼ 10 -17 cm 2 that is comparable with the efficiency of excitation of the laser lines [ru
Padhee, S. K.; Nikam, B. R.; Aggarwal, S. P.; Garg, V.
2014-11-01
Drought is an extreme condition due to moisture deficiency and has adverse effect on society. Agricultural drought occurs when restraining soil moisture produces serious crop stress and affects the crop productivity. The soil moisture regime of rain-fed agriculture and irrigated agriculture behaves differently on both temporal and spatial scale, which means the impact of meteorologically and/or hydrological induced agriculture drought will be different in rain-fed and irrigated areas. However, there is a lack of agricultural drought assessment system in Indian conditions, which considers irrigated and rain-fed agriculture spheres as separate entities. On the other hand recent advancements in the field of earth observation through different satellite based remote sensing have provided researchers a continuous monitoring of soil moisture, land surface temperature and vegetation indices at global scale, which can aid in agricultural drought assessment/monitoring. Keeping this in mind, the present study has been envisaged with the objective to develop agricultural drought assessment and prediction technique by spatially and temporally assimilating effective drought index (EDI) with remote sensing derived parameters. The proposed technique takes in to account the difference in response of rain-fed and irrigated agricultural system towards agricultural drought in the Bundelkhand region (The study area). The key idea was to achieve the goal by utilizing the integrated scenarios from meteorological observations and soil moisture distribution. EDI condition maps were prepared from daily precipitation data recorded by Indian Meteorological Department (IMD), distributed within the study area. With the aid of frequent MODIS products viz. vegetation indices (VIs), and land surface temperature (LST), the coarse resolution soil moisture product from European Space Agency (ESA) were downscaled using linking model based on Triangle method to a finer resolution soil moisture product
Rietdijk, Judith; Ising, Helga K; Dragt, Sara; Klaassen, Rianne; Nieman, Dorien; Wunderink, Lex; Cuijpers, Pim; Linszen, Don; van der Gaag, Mark
2013-10-30
Knowledge on associations between ultra-high risk (UHR) for developing psychosis and on non-psychotic psychopathology in help-seeking populations is limited with respect to differences between male and female patients. The present study tests the hypothesis that both social anxiety and depression are highly prevalent in an UHR population, particularly among women. From February 2008 to February 2010 baseline data were collected from help-seeking subjects (14-35 years) who were included in the Dutch Early Detection and Intervention Evaluation (EDIE-NL) trial. Two recruiting strategies were used: a two-stage screening strategy in a population of consecutive help-seeking and distressed subjects of secondary mental health services, and a referral strategy. This study included 201 patients with a mean age of 22.7 years. Of these, 102 (51%) were female, 58% of the patients met the criteria for clinical depression on the Beck Depression Inventory and 42% met the criteria for clinical social phobia on the Social Interaction Anxiety Scale. Women showed more depression and social anxiety than men. The results support the hypothesis that UHR is associated with depression and social anxiety, particularly in women. Screening a help-seeking population with depression and anxiety may be effective in detecting patients at UHR for developing psychosis. Copyright © 2013 Elsevier Ireland Ltd. All rights reserved.
DEFF Research Database (Denmark)
Tartaglione, Girolamo; Stoeckli, Sandro J; de Bree, Remco
2016-01-01
/static scan and/or SPECT/CT. RESULTS: Lymphoscintigraphy identified 723 lymphatic basins. 1398 sentinel lymph nodes (SNs) were biopsied (3.2 SN per patient; range, 1-10). Dynamic scan allowed the differentiation of sentinel nodes from second tier lymph nodes. SPECT/CT allowed more accurate anatomical......PURPOSE: Nuclear imaging plays a crucial role in lymphatic mapping of oral cancer. This evaluation represents a subanalysis of the original multicenter SENT trial data set, involving 434 patients with T1-T2, N0, and M0 oral squamous cell carcinoma. The impact of acquisition techniques, tracer...... localization and estimated SN depth more efficiently. After pathological examination, 9.9% of the SN excised (138 of 1398 SNs) showed metastases. The first neck level (NL) containing SN+ was NL I in 28.6%, NL IIa in 44.8%, NL IIb in 2.8%, NL III in 17.1%, and NL IV in 6.7% of positive patients. Approximately...
Biorefinery.nl 2006 : the results of the 1st year of the Dutch Network on Biorefinery, BioRef 0606
Zwart, R.W.R.; Ree, van R.; Annevelink, E.; Jong, de E.
2006-01-01
The Dutch Network on Biorefinery (Biorefinery.nl) is a joint initiative of the Energy research Centre of the Netherlands (ECN) and Wageningen University and Research Centre (WUR). It is meant to inform industry, research institutes, universities, NGOs, governments and the general public about
Rooij, van S.A.M.; Baveco, J.M.; Bugter, R.J.F.; Eupen, van M.; Opdam, P.F.M.; Steingröver, E.G.; Taylor, S.; Steenwijk, van H.
2007-01-01
This study is part of the BRANCH project, aimed at assessing the impact of climate change on species and habitats and formulating strategies for adaptation. It focuses on the local scale in three terrestrial case studies, Limburg (NL) and in Kent and Hampshire (UK). We developed and tested: (a) a
Evaluating the Flipped Classroom: A Randomized Controlled Trial
Wozny, Nathan; Balser, Cary; Ives, Drew
2018-01-01
Despite recent interest in flipped classrooms, rigorous research evaluating their effectiveness is sparse. In this study, the authors implement a randomized controlled trial to evaluate the effect of a flipped classroom technique relative to a traditional lecture in an introductory undergraduate econometrics course. Random assignment enables the…
Moonen, A; Busch, O; Costantini, M; Finotti, E; Tack, J; Salvador, R; Boeckxstaens, G; Zaninotto, G
2017-11-01
A recent multicenter randomized trial in achalasia patients has shown that pneumatic dilation resulted in equivalent relief of symptoms compared to laparoscopic Heller myotomy. Additionally, the cost of each treatment should be also taken in consideration. Therefore, the aim of the present study was to perform an economic analysis of the European achalasia trial. Patients with newly diagnosed achalasia were enrolled from to 2003 to 2008 in 14 centers in five European countries and were randomly assigned to either pneumatic dilation (PD) or laparoscopic Heller (LHM). The economic analysis was performed in the three centers in three different countries where most patients were enrolled (Amsterdam [NL], Leuven, [B] and Padova [I]) and then applied to all patients included in the study. The total raw costs of the two treatments per patient include the initial costs, the costs of complications, and the costs of retreatments. Two hundred and one patients, 107 (57 males and 50 females, mean age 46 CI: 43-49 years) were randomized to LHM and 94 (59 males and 34 females, mean age 46 CI 43-50 years) to PD. The total cost of PD per patient was quite comparable in the three different centers; €3397 in Padova, €3259 in Amsterdam and €3792 in Leuven. For LHM, the total costs per patient were highest in Amsterdam: €4488 in Padova, €6720 in Amsterdam, and €5856 in Leuven. In conclusion, the strategy of treating achalasia starting with PD appears the most economic approach, independent of the health system. © 2017 John Wiley & Sons Ltd.
Skipp, Amy; Windfuhr, Kirsten L; Conti-Ramsden, Gina
2002-01-01
The study investigated the development of grammatical categories (noun and verb) in young language learners. Twenty-eight children with specific language impairment (SLI) with a mean language age of 35 months and 28 children with normal language (NL) with a mean language age of 34 months were exposed to four novel verbs and four novel nouns during 10 experimental child-directed play sessions. The lexical items were modelled with four experimentally controlled argument structures. Both groups of children showed little productivity with syntactic marking of arguments in the novel verb conditions. Thus, both groups of children mostly followed the surface structure of the model presented to them, regardless of the argument they were trying to express. Therefore, there was little evidence of verb-general processes. In contrast, both groups used nouns in semantic roles that had not been modelled for them. Importantly, however, children with SLI still appeared to be more input dependent than NL children. This suggests that children with NL were working with a robust noun schema, whereas children with SLI were not. Taken together, the findings suggest that neither group of children had a grammatical category of verb, but demonstrated a general knowledge of the grammatical category of noun. These findings are discussed in relation to current theories of normal and impaired language development.
Energy Technology Data Exchange (ETDEWEB)
1991-09-27
The 44-acre NL Industries site is an inactive, secondary lead smelting facility in Pedricktown, Salem County, New Jersey. The site overlies the Cape May aquifer, a potential source of drinking water for local residents. In 1989, EPA began a multi-phased removal action. The Focused Feasibility Study resulted in the issuance of the Early Remedial Action Record of Decision (ROD), designated as Operable Unit (OU2). The nature and extent of remaining contamination on the site and areas adjacent to the site in various environmental media, such as soil, sediment, ground water, surface water, and air, are currently being evaluated and will be addressed as OU1 in a subsequent ROD. The primary contaminants of concern affecting the slag and lead oxide piles, sediment, debris, and standing surface water are metals including arsenic, chromium, and lead. The selected remedial action for the site is included.
Cox, Vincent Cm; Schepers, Vera Pm; Ketelaar, Marjolijn; van Heugten, Caroline M; Visser-Meily, Johanna Ma
2018-02-16
partners of patients with acquired brain injury. Barriers and facilitators that emerge from the process evaluation will be used in the nationwide implementation of the intervention. Dutch Trial Register NTR6197; http://www.trialregister.nl/trialreg/admin/rctview.asp?TC=6197 (Archived by WebCite at http://www.webcitation.org/6xHBAxx0y). ©Vincent CM Cox, Vera PM Schepers, Marjolijn Ketelaar, Caroline M van Heugten, Johanna MA Visser-Meily. Originally published in JMIR Research Protocols (http://www.researchprotocols.org), 16.02.2018.
Evaluation of the physicians‘ of n hospital opinion on clinical trials of medicinal products
Videikaitė, Lina
2014-01-01
Aim of the research. To evaluate the physicians‘ of N Hospital opinion on clinical trials of medicinal products. Objectives. To evaluate the factors affecting physicians' motivation to perform clinical trials of medicinal products as well as those that prevent the physicians getting involved in the trials. To assess physicians' attitude towards clinical trials of medicinal products. To compare the opinions of physicians who have and have’nt participated in clinical trials. Methods of...
Directory of Open Access Journals (Sweden)
Adriana Silvina Pagano
2014-03-01
Full Text Available Este artigo examina dados de um experimento-piloto e tem por objetivo investigar o esforço despendido por estudantes de tradução em uma tarefa de pós-edição, a partir da análise de pausas e movimentos recursivos registrados durante a produção textual em tempo real para instâncias gramaticalmente metafóricas (cf. HALLIDAY,1998. O estudo contempla o processo e o produto da pós-edição de três alunos de pós-graduação em tradução. Para se proceder à análise, foram observados os registros de uso de teclado e movimentos de cursor mapeados pelo programa Translog 2006 para a produção textual em tempo real. Como resultado, verificou-se um grande esforço para se processar algumas instâncias gramaticalmente metafóricas, sendo que esse esforço não resultou em uma maior adequação dos significados produzidos.
Avaliação da anotação semântica do PALAVRAS e sua pós-edição manual para o Corpus Summ-it
Directory of Open Access Journals (Sweden)
Élen Cátia Tomazela
2011-01-01
Full Text Available Este artigo apresenta uma avaliação da anotação semântica automática do parser PALAVRAS e sua pós-edição manual para um corpus de textos em português – o Corpus Summ-it. Essa pós-edição visou ao aprimoramento de um modelo linguístico para a sumarização automática de textos e buscou atribuir etiquetas semânticas mais adequadas aos itens lexicais, comparadas às empregadas pelo parser. Essa tarefa foi realizada por linguistas e os casos problemáticos são apresentados neste artigo, os quais levam a considerações sobre o próprio modelo de etiquetagem do PALAVRAS. O corpus revisado estará disponível para a comunidade e poderá ser útil para várias aplicações de Processamento de Línguas Naturais.
Avaliação da anotação semântica do PALAVRAS e sua pós-edição manual para o Corpus Summ-it
Directory of Open Access Journals (Sweden)
Élen Cátia Tomazela
2011-01-01
Full Text Available Este artigo apresenta uma avaliação da anotação semântica automática do parser PALAVRAS e sua pós-edição manual para um corpus de textos em português – o Corpus Summ-it. Essa pós-edição visou ao aprimoramento de um modelo linguístico para a sumarização automática de textos e buscou atribuir etiquetas semânticas mais adequadas aos itens lexicais, comparadas às empregadas pelo parser. Essa tarefa foi realizada por linguistas e os casos problemáticos são apresentados neste artigo, os quais levam a considerações sobre o próprio modelo de etiquetagem do PALAVRAS. O corpus revisado estará disponível para a comunidade e poderá ser útil para várias aplicações de Processamento de Línguas Naturais.
Evaluating the design and reporting of pragmatic trials in osteoarthritis research.
Ali, Shabana Amanda; Kloseck, Marita; Lee, Karen; Walsh, Kathleen Ellen; MacDermid, Joy C; Fitzsimmons, Deborah
2018-01-01
Among the challenges in health research is translating interventions from controlled experimental settings to clinical and community settings where chronic disease is managed daily. Pragmatic trials offer a method for testing interventions in real-world settings but are seldom used in OA research. The aim of this study was to evaluate the literature on pragmatic trials in OA research up to August 2016 in order to identify strengths and weaknesses in the design and reporting of these trials. We used established guidelines to assess the degree to which 61 OA studies complied with pragmatic trial design and reporting. We assessed design according to the pragmatic-explanatory continuum indicator summary and reporting according to the pragmatic trials extension of the CONsolidated Standards of Reporting Trials guidelines. None of the pragmatic trials met all 11 criteria evaluated and most of the trials met between 5 and 8 of the criteria. Criteria most often unmet pertained to practitioner expertise (by requiring specialists) and criteria most often met pertained to primary outcome analysis (by using intention-to-treat analysis). Our results suggest a lack of highly pragmatic trials in OA research. We identify this as a point of opportunity to improve research translation, since optimizing the design and reporting of pragmatic trials can facilitate implementation of evidence-based interventions for OA care. © The Author 2017. Published by Oxford University Press on behalf of the British Society for Rheumatology. All rights reserved. For Permissions, please email: journals.permissions@oup.com
Numerical evaluation of the tensor bispectrum in two field inflation
Energy Technology Data Exchange (ETDEWEB)
Raveendran, Rathul Nath [The Institute of Mathematical Sciences, HBNI, CIT Campus, Chennai, 600113 India (India); Sriramkumar, L., E-mail: rathulnr@imsc.res.in, E-mail: sriram@physics.iitm.ac.in [Department of Physics, Indian Institute of Technology Madras, Chennai, 600036 India (India)
2017-07-01
We evaluate the dimensionless non-Gaussianity parameter h {sub NL}, that characterizes the amplitude of the tensor bispectrum, numerically for a class of two field inflationary models such as double inflation, hybrid inflation and aligned natural inflation. We compare the numerical results with the slow roll results which can be obtained analytically. In the context of double inflation, we also investigate the effects on h {sub NL} due to curved trajectories in the field space. We explicitly examine the validity of the consistency relation governing the tensor bispectrum in the squeezed limit. Lastly, we discuss the contribution to h {sub NL} due to the epoch of preheating in two field models.
Numerical evaluation of the tensor bispectrum in two field inflation
International Nuclear Information System (INIS)
Raveendran, Rathul Nath; Sriramkumar, L.
2017-01-01
We evaluate the dimensionless non-Gaussianity parameter h NL , that characterizes the amplitude of the tensor bispectrum, numerically for a class of two field inflationary models such as double inflation, hybrid inflation and aligned natural inflation. We compare the numerical results with the slow roll results which can be obtained analytically. In the context of double inflation, we also investigate the effects on h NL due to curved trajectories in the field space. We explicitly examine the validity of the consistency relation governing the tensor bispectrum in the squeezed limit. Lastly, we discuss the contribution to h NL due to the epoch of preheating in two field models.
Kur’an’a Göre Üstünlük Duygusunun Düşünce ve Davranışlara Etkileri
Directory of Open Access Journals (Sweden)
Harun Savut
2015-06-01
Full Text Available Üstünlük duygusu insanın tüm davranışlarını etkisi altına alan, düşünce ve davranışlarda sapmalara sebep olan bir tavırdır. Doğruyu kendisini merkeze koyarak değerlendiren insanın tüm kutsalı yine kendisi olur. Şayet çevredekiler bu kutsalı onaylarsa kabul edilir ve değer görürler. Aksinin söz konusu olduğu durumlarda ise karşı durulması gereken düşman şeklinde algılanırlar. Bu ise akli melekelerin önünde set oluşturan, doğru düşünmeyi negatif yönde etkileyen, bu sebeple de yanlışları tetikleyen bir durumdur. Bunun neticesinde hakkın kabulü zorlaşır, hatta imkansız bir hal alır. İnsanı kendi algısı ile çelişen gerçekleri, doğruları inkara sürükler. Benlik kaynaklı bu savrulma küfür ve şirkin kapılarını açar. Bu makalede üstünlük hissinin yol açtığı algı ve düşünme hatalarıyla tebarüz eden kişilerin düşüncelerinde ortaya çıkan savrulmalar, yanılsamalar analiz edilmiştir. Üstünlük algısının gerekçelendirilmesinde kişi veya toplumun sahip olduğu imkanların rolü değerlendirilmiştir. Üstünlük hissinin neden olduğu tahammülsüzlük ve algı kapanması üzerinde durulmuştur.
Process evaluation of a web-based intervention aimed at empowerment of disability benefit claimants
Directory of Open Access Journals (Sweden)
Anema Johannes R
2011-02-01
Full Text Available Abstract Background The objective of this process evaluation study was to gain insight into the reach, compliance, appreciation, usage barriers, and users' perceived effectiveness of a web-based intervention http://www.wiagesprek.nl. This intervention was aimed at empowerment of disability claimants, prior to the assessment of disability by an insurance physician. Methods Reach was determined by registering claimants exposed to the study's invitation brochures, and by comparing trial participant characteristics with non-participants and nationwide claimant data. Compliance was registered by analyzing weblogs, which were automatically collected during the period of the trial. This made it possible to analyze individual use of the intervention. Appreciation, usage barriers, and users' perceived effectiveness were assessed using an online questionnaire that was sent to participants from the intervention group, 6 weeks after enrolment. Results Only 9% of the target population enrolled in the internet program. Because of selective enrolment, more females, higher educated claimants, and less ethnical minorities were reached. Compliance was ambiguous: out of the 123 participants randomized into the intervention group, a significant proportion (33% did not use the intervention at all, while, at the same time, many participants (32% used the intervention for more than two hours (i.e. in approximately two weeks. Overall satisfaction with the intervention was good. Claimants perceived the intervention most effective in increasing knowledge, while also a fair amount of users perceived the intervention effective in gaining right expectations or being able to communicate better with their physician. Conclusions The uptake of the intervention http://www.wiagesprek.nl was disappointing. Specifically, the poor reach and compliance of the intervention resulted in a small proportion of the target population using the intervention as intended. Improvements in the
Neutralization of X4- and R5-tropic HIV-1 NL4-3 variants by HOCl-modified serum albumins
Directory of Open Access Journals (Sweden)
Schwalbe Birco
2010-06-01
Full Text Available Abstract Background Myeloperoxidase (MPO, an important element of the microbicidal activity of neutrophils, generates hypochlorous acid (HOCl from H2O2 and chloride, which is released into body fluids. Besides its direct microbicidal activity, HOCl can react with amino acid residues and HOCl-modified proteins can be detected in vivo. Findings This report is based on binding studies of HOCl-modified serum albumins to HIV-1 gp120 and three different neutralization assays using infectious virus. The binding studies were carried out by surface plasmon resonance spectroscopy and by standard ELISA techniques. Virus neutralization assays were carried out using HIV-1 NL4-3 virus and recombinant strains with CXCR4 and CCR5 coreceptor usage. Viral infection was monitored by a standard p24 or X-gal staining assay. Our data demonstrate that HOCl-modified mouse-, bovine- and human serum albumins all bind to the HIV-1 NL4-3 gp120 (LAV glycoprotein in contrast to non-modified albumin. Binding of HOCl-modified albumin to gp120 correlated to the blockade of CD4 as well as that of V3 loop specific monoclonal antibody binding. In neutralization experiments, HOCl-modified serum albumins inhibited replication and syncytium formation of the X4- and R5-tropic NL4-3 isolates in a dose dependent manner. Conclusions Our data indicate that HOCl-modified serum albumin veils the binding site for CD4 and the V3 loop on gp120. Such masking of the viral gp120/gp41 envelope complex might be a simple but promising strategy to inactivate HIV-1 and therefore prevent infection when HOCl-modified serum albumin is applied, for example, as a topical microbicide.
Applying Real Options for Evaluating Investments in ERP Systems
Nakagane, Jun; Sekozawa, Teruji
This paper intends to verify effectiveness of real options approach for evaluating investments in Enterprise Resource Planning systems (ERP) and proves how important it is to disclose shadow options potentially embedded in ERP investment. The net present value (NPV) method is principally adopted to evaluate the value of ERP. However, the NPV method assumes no uncertainties exist in the object. It doesn't satisfy the current business circumstances which are filled with dynamic issues. Since the 1990s the effectiveness of option pricing models for Information System (IS) investment to solve issues in the NPV method has been discussed in the IS literature. This paper presents 3 business cases to review the practical advantages of such techniques for IS investments, especially ERP investments. The first case is EDI development. We evaluate the project by a new approach with lighting one of shadow options, EDI implementation. In the second case we reveal an ERP investment has an “expanding option” in a case of eliminating redundancy. The third case describes an option to contract which is deliberately slotted in ERP development to prepare transferring a manufacturing facility.
Plasma convection in the magnetotail lobes: statistical results from Cluster EDI measurements
Directory of Open Access Journals (Sweden)
S. Haaland
2008-08-01
Full Text Available A major part of the plasma in the Earth's magnetotail is populated through transport of plasma from the solar wind via the magnetotail lobes. In this paper, we present a statistical study of plasma convection in the lobes for different directions of the interplanetary magnetic field and for different geomagnetic disturbance levels. The data set used in this study consists of roughly 340 000 one-minute vector measurements of the plasma convection from the Cluster Electron Drift Instrument (EDI obtained during the period February 2001 to June 2007. The results show that both convection magnitude and direction are largely controlled by the interplanetary magnetic field (IMF. For a southward IMF, there is a strong convection towards the central plasma sheet with convection velocities around 10 km s−1. During periods of northward IMF, the lobe convection is almost stagnant. A By dominated IMF causes a rotation of the convection patterns in the tail with an oppositely directed dawn-dusk component of the convection for the northern and southern lobe. Our results also show that there is an overall persistent duskward component, which is most likely a result of conductivity gradients in the footpoints of the magnetic field lines in the ionosphere.
Duan, Da-Peng; You, Wu-Lin; Ji, Le; Zhang, Yong-Tao; Dang, Xiao-Qian; Wang, Kun-Zheng
2014-01-01
To analyze the effects of three surgical operations in the treatment of Pilon fracture of Rüedi-Allgower type III, and put forward the best therapeutic method. The clinical data of 33 patients with Pilon fracture who received surgical operations (plaster immobilization group, 10 cases; distal tibia anatomical plate group, 11 cases; external fixation with limited internal fixation group, 12 cases) from October 2009 to January 2012 were analyzed. There were 5 males and 5 females, ranging in age from 24 to 61 years in the plaster immobilization group. There were 7 males and 4 females, ranging in age from 21 to 64 years in the distal tibia anatomical plate group. There were 7 males and 5 females, ranging in age from 23 to 67 years in the external fixation with limited internal fixation group. The Ankle X-ray of Pilon fracture after operation, ankle score, early and late complications were collected. Bourne system was used to evaluate ankle joint function. After 8 months to 3 years follow-up, it was found that three kinds of treatment had significant differences in the outcomes and complications (P external fixation with limited internal fixation group got the best results. The number of anatomic reduction cases in the external fixation with limited internal fixation group (7 cases) and the distal tibia anatomical plate group (8 cases) was more than the plaster immobilization group (2 cases). According to the ankle score, 8 patients got an excellent result, 3 good and 1 poor in the limited internal fixation group ,which was better than those of distal tibia anatomical plate group (5 excellent, 4 good and 2 poor) and the plaster immobilization group (3 excellent, 4 good and 3 poor). The number of early and late complications in the external fixation with limited internal fixation group was more than those in the plaster immobilization group and the distal tibia anatomical plate group (Pexternal fixation with limited internal fixation in the treatment of Pilon fracture
Fiore, Tito; Iaccheri, Barbara; Cerquaglia, Alessio; Lupidi, Marco; Torroni, Giovanni; Fruttini, Daniela; Cagini, Carlo
2018-01-01
To perform an analysis of optical coherence tomography (OCT) abnormalities in patients with MEWDS, during the acute and recovery stages, using enhanced depth imaging-OCT (EDI-OCT). A retrospective case series of five patients with MEWDS was included. EDI-OCT imaging was evaluated to detect retinal and choroidal features. In the acute phase, focal impairment of the ellipsoid zone and external limiting membrane, hyperreflective dots in the inner choroid, and full-thickness increase of the choroidal profile were observed in the affected eye; disappearance of these findings and restoration of the choroidal thickness (p = 0.046) was appreciated in the recovery phase. No OCT abnormalities were assessed in the unaffected eye. EDI-OCT revealed transient outer retinal layer changes and inner choroidal hyperreflective dots. A transient increased thickness of the whole choroid was also identified. This might confirm a short-lasting inflammatory involvement of the whole choroidal tissue in the active phase of MEWDS.
A Portal to Dutch Academic Heritage: www.academischecollecties.nl
Directory of Open Access Journals (Sweden)
Henriette Reerink
2013-01-01
Full Text Available The UNICUM development project, commissioned by the Dutch Academic Heritage Foundation Stichting Academisch Erfgoed (SAE, has been carried out by the five classic Dutch universities in 2010– 2012. UNICUM, short for ‘University Collections and University Museums’, has received a national government grant to create a digital portal to Dutch academic heritage. The portal, which can be reached via www.academischecollecties.nl, presents both academic archives and museum and library collections. Images, collection metadata and items can be found on one site. The UNICUM idea is inspired by the Online Archive of California. The project is important because it crosses the traditional sector boundaries between museums, libraries and archives, it creates awareness of the opportunities which this cross-sectoral approach offers, and it retains the context of – and the relation between – objects within collections as a whole. Moreover, the joint effort brings to light the importance of creating metadata according to international standards to stimulate re-use and exchange of content. In addition, UNICUM intended to be a technical project in which multi-level descriptions are presented and can be browsed in a structured way (collections linked to objects, and archives linked to separate documents. Now the project is finished, the focus will shift to generating content.
Reina, J; López-Causapé, C; Rojo-Molinero, E; Rubio, R
2014-12-01
Acute respiratory infection is a very common condition in the general population. The majority of these infections are due to viruses. This study attempted to determine the clinical and epidemiological characteristics of adult patients with respiratory infection by the coronavirus OC43, NL63 and 229E. Between January 2013 and February 2014, we prospectively studied all patients with suspected clinical respiratory infection by taking throat swabs and performing a reverse transcription polymerase chain reaction in search of coronavirus. In 48 cases (7.0% of the 686 enrolled patients; 12.6% of the 381 in whom a virus was detected) the presence of a coronavirus demonstrated. In 24 cases, the virus was OC43 (50%); in 14 cases, the virus was NL63 (29%); and in 10 cases, the virus was 229E (21%). The mean age was 54.5 years, with a slight predominance of men. The most common clinical presentations were nonspecific influenza symptoms (43.7%), pneumonia (29.2%) and chronic obstructive pulmonary disease exacerbation (8.3%). Fifty-two percent of the patients required hospitalization, and 2 patients required intensive care. There were no deaths. Acute respiratory infections caused by coronavirus mainly affect middle-aged male smokers, who are often affected by previous diseases. The most common clinical picture has been nonspecific influenza symptoms. Copyright © 2014 Elsevier España, S.L.U. All rights reserved.
The Correction of Myopia Evaluation Trial: lessons from the study design.
Hyman, L; Gwiazda, J
2004-01-01
The Correction of Myopia Evaluation Trial (COMET), a multicentre clinical trial based in 4 schools of optometry in the United States, evaluated the effect of progressive addition lenses versus single vision lenses on myopia progression in an ethnically diverse group of 469 myopic children aged 6 to 11 years. Completion of the clinical trial phase of the study provides an opportunity to evaluate aspects of the study design that contribute to its success. This article describes aspects of the study design that were influential in ensuring the smooth conduct of COMET. These include a dedicated team of investigators, an organisational structure with strong leadership and an independent Co-ordinating Centre, regular communication among investigators, flexible and creative approaches to recruitment and retention, sensitivity to concerns for child safety and child participation, and methods for enhancing and monitoring data reliability. The experience with COMET has provided a number of valuable lessons for all aspects of the study design that should benefit the development and implementation of future clinical trials, particularly those done in similar populations of children. The use of a carefully designed protocol using standard methods by dedicated members of the study team is essential in ensuring achievement of the study aims.
evaluation of growth of young coconut and nut yield of old coconut
African Journals Online (AJOL)
User
nutrient status under coconut-cassava intercropping systems. Experiment I was ... farmer's income/ food security base and helps in weed control ... GenStat Discovery Edi- tion 3 statistical ..... nut, it did not impact on nut yield since it was not a limiting ... Evaluation of crop management options ... (1996). Manual on standard-.
2010-03-01
Afghanistan.” 2009. http://www.coleparmer.com/techinfo/techinfo.asp?htmlfile= water - afghanistan.htm&ID=964. Christ- wasser . “RO, EDI and optional UF...Cover, Single-Author Thesis EVALUATION OF ALTERNATIVE TECHNOLOGIES TO SUPPLY DRINKING WATER TO MARINES IN FORWARD DEPLOYED...AFIT/GES/ENV/10-M02 EVALUATION OF ALTERNATIVE TECHNOLOGIES TO SUPPLY DRINKING WATER TO MARINES IN FORWARD DEPLOYED
Emerencia, Ando C; Boonstra, Nynke; Wunderink, Lex; de Jonge, Peter; Sytema, Sjoerd
2013-01-01
on perceived involvement in medical decision making (COMRADE satisfaction with communication: F1,68=0.422, P=.52; COMRADE confidence in decision: F1,67=0.086, P=.77). In addition, results of the process evaluation suggest that the intervention did not optimally fit in with routine practice of the participating teams. Conclusions The development of electronic decision aids to facilitate shared medical decision making is encouraged and many people with a psychotic disorder can work with them. This holds for both first-episode patients and long-term care patients, although the latter group might need more assistance. However, results of this paper could not support the assumption that the use of electronic decision aids increases patient involvement in medical decision making. This may be because of weak implementation of the study protocol and a low response rate. Trial Registration Dutch Trial Register (NTR) trial number: 10340; http://www.trialregister.nl/trialreg/admin/rctsearch.asp?Term=10340 (Archived by WebCite at http://www.webcitation.org/6Jj5umAeS). PMID:24100091
The Psychology of Music, editado por Diana Deutsch, 3ª edição: resenha dos capítulos 10 a 13
Directory of Open Access Journals (Sweden)
Ricieri Carlini Zorzal
2016-03-01
Full Text Available O presente texto traz uma resenha de quatro capítulos da terceira edição do livro The Psychology of Music, editado por Diana Deutsch. Nominalmente, são analisados os seguintes capítulos: 10 Performance musical: movimento e coordenação, de autoria de Caroline Palmer; 11 Desenvolvimento musical, de autoria de Laurel Trainor e Erin Hannon; 12 Música e habilidades cognitivas, de autoria de Glenn Schellenberg e Michael Weiss; e 13 As fundações biológicas da música: insights da amusia congênita, de autoria de Isabelle Peretz.
DEFF Research Database (Denmark)
Nielsen, Niklas; Friberg, Hans; Gluud, Christian
2011-01-01
BACKGROUND: Guidelines recommend mild induced hypothermia (MIH) to reduce mortality and neurological impairment after out-of-hospital cardiac arrest. Our objective was to systematically evaluate the evidence for MIH taking into consideration the risks of systematic and random error and to GRADE...... the evidence. METHODS: Systematic review with meta-analysis and trial sequential analysis of randomised trials evaluating MIH after cardiac arrest in adults. We searched CENTRAL, MEDLINE, and EMBASE databases until May 2009. Retrieved trials were evaluated with Cochrane methodology. Meta-analytic estimates....... The substantial risk of bias and concerns with directness rated down the quality of the evidence to low. CONCLUSIONS: Evidence regarding MIH after out-of-hospital cardiac arrest is still inconclusive and associated with non-negligible risks of systematic and random errors. Using GRADE-methodology, we conclude...
Australasian Resuscitation In Sepsis Evaluation trial statistical analysis plan.
Delaney, Anthony; Peake, Sandra L; Bellomo, Rinaldo; Cameron, Peter; Holdgate, Anna; Howe, Belinda; Higgins, Alisa; Presneill, Jeffrey; Webb, Steve
2013-10-01
The Australasian Resuscitation In Sepsis Evaluation (ARISE) study is an international, multicentre, randomised, controlled trial designed to evaluate the effectiveness of early goal-directed therapy compared with standard care for patients presenting to the ED with severe sepsis. In keeping with current practice, and taking into considerations aspects of trial design and reporting specific to non-pharmacologic interventions, this document outlines the principles and methods for analysing and reporting the trial results. The document is prepared prior to completion of recruitment into the ARISE study, without knowledge of the results of the interim analysis conducted by the data safety and monitoring committee and prior to completion of the two related international studies. The statistical analysis plan was designed by the ARISE chief investigators, and reviewed and approved by the ARISE steering committee. The data collected by the research team as specified in the study protocol, and detailed in the study case report form were reviewed. Information related to baseline characteristics, characteristics of delivery of the trial interventions, details of resuscitation and other related therapies, and other relevant data are described with appropriate comparisons between groups. The primary, secondary and tertiary outcomes for the study are defined, with description of the planned statistical analyses. A statistical analysis plan was developed, along with a trial profile, mock-up tables and figures. A plan for presenting baseline characteristics, microbiological and antibiotic therapy, details of the interventions, processes of care and concomitant therapies, along with adverse events are described. The primary, secondary and tertiary outcomes are described along with identification of subgroups to be analysed. A statistical analysis plan for the ARISE study has been developed, and is available in the public domain, prior to the completion of recruitment into the
EVALUATION OF OXIDATIVE STRESS IN DAIRY GOATS LACTATING NATURALLY OR BY HORMONAL INDUCTION
Directory of Open Access Journals (Sweden)
Rocio Teresa García-Balcázar
2016-08-01
Full Text Available The objective was to evaluate the oxidative stress (OS and its association with performance and serum cortisol in dairy goats under induced (IL and natural lactation (NL. Six goats programmed to be eliminated due to reproductive problems were IL as follows: a days 1-7, estradiol plus progesterone; b days 8-14, estradiol; c days 18-20, flumetasone; d every seven days bovine somatotropin; f on day 21 milking began. Cortisol, antioxidant capacity and Glutathione Peroxidase activity (GHS-Px were determined in serum. During the first two weeks in milk, NL goats had higher cortisol (P0.05. Milk yield/day between groups (NL=2.54+0.2; IL= 2.12+0.2kg and proportion of pregnant goats (NL=100%; IL=83.3% were similar (P>0.05. The treatment was effective as inductor of lactation; besides most of the IL animals became pregnant despite their previous reproductive problems, prolonging their productive life with a natural lactation plus the additional benefit of at least one more kid. Because the antioxidant capacity increased and cortisol decreased in IL goats, apparently their welfare was more adequate than in NL animals.
Erkens, Sandra; Kasbergen, C.; Villani, M.M.; Scarpas, Athanasios; Florio, E.; Berti, C.
2014-01-01
Sinds 2008 werken we in Nederland met functionele eigenschappen voor asfalt
beton. Hierbij wordt niet zo zeer op het “recept” van het asfalt gestuurd, als
wel op de eigenschappen ervan die van belang zijn voor het gedrag in de weg.
Binnen het NL-LAB programma wordt de relatie tussen deze
Directory of Open Access Journals (Sweden)
M. Förster
2008-09-01
Full Text Available In this study, we investigate statistical, systematic variations of the high-latitude convection cell structure during northward IMF. Using 1-min-averages of Cluster/EDI electron drift observations above the Northern and Southern polar cap areas for six and a half years (February 2001 till July 2007, and mapping the spatially distributed measurements to a common reference plane at ionospheric level in a magnetic latitude/MLT grid, we obtained regular drift patterns according to the various IMF conditions. We focus on the particular conditions during northward IMF, where lobe cells at magnetic latitudes >80° with opposite (sunward convection over the central polar cap are a permanent feature in addition to the main convection cells at lower latitudes. They are due to reconnection processes at the magnetopause boundary poleward of the cusp regions. Mapped EDI data have a particular good coverage within the central part of the polar cap, so that these patterns and their dependence on various solar wind conditions are well verified in a statistical sense. On average, 4-cell convection pattern are shown as regular structures during periods of nearly northward IMF with the tendency of a small shift toward negative clock angles. The positions of these high-latitude convection foci are within 79° to 85° magnetic latitude and 09:00–15:00 MLT. The MLT positions are approximately symmetric ±2 h about 11:30 MLT, i.e. slightly offset from midday toward prenoon hours, while the maximum (minimum potential of the high-latitude cells is at higher magnetic latitudes near their maximum potential difference at ≈−10° to −15° clock angle for the North (South Hemisphere. With increasing clock angle distances from ≈IMFBz+, a gradual transition occurs from the 4-cell pattern via a 3-cell to the common 2-cell convection pattern, in the course of which one of the medium-scale high-latitude dayside cells diminishes and disappears while the
Sociocultural Attitudes and Symptoms of Bulimia: Evaluating the SATAQ with Diverse College Groups
Cashel, Mary Louise; Cunningham, Dana; Landeros, Clarinda; Cokley, Kevin O.; Muhammad, Grace
2003-01-01
This study evaluated the utility of the Sociocultural Attitudes Towards Appearance Questionnaire (SATAQ; L. J. Heinberg, J. K. Thompson, & S. Stormer, 1995) for the assessment of diverse college groups, including men, women, minorities, and sorority members. Scores from the SATAQ were compared with the Eating Disorder Inventory-2 (EDI-2; D. M.…
van Staa, Tjeerd-Pieter; Dyson, Lisa; McCann, Gerard; Padmanabhan, Shivani; Belatri, Rabah; Goldacre, Ben; Cassell, Jackie; Pirmohamed, Munir; Torgerson, David; Ronaldson, Sarah; Adamson, Joy; Taweel, Adel; Delaney, Brendan; Mahmood, Samhar; Baracaia, Simona; Round, Thomas; Fox, Robin; Hunter, Tommy; Gulliford, Martin; Smeeth, Liam
BACKGROUND: Pragmatic trials compare the effects of different decisions in usual clinical practice. OBJECTIVES: To develop and evaluate methods to implement simple pragmatic trials using routinely collected electronic health records (EHRs) and recruiting patients at the point of care; to identify
A pragmatic cluster randomised trial evaluating three implementation interventions
Directory of Open Access Journals (Sweden)
Rycroft-Malone Jo
2012-08-01
Full Text Available Abstract Background Implementation research is concerned with bridging the gap between evidence and practice through the study of methods to promote the uptake of research into routine practice. Good quality evidence has been summarised into guideline recommendations to show that peri-operative fasting times could be considerably shorter than patients currently experience. The objective of this trial was to evaluate the effectiveness of three strategies for the implementation of recommendations about peri-operative fasting. Methods A pragmatic cluster randomised trial underpinned by the PARIHS framework was conducted during 2006 to 2009 with a national sample of UK hospitals using time series with mixed methods process evaluation and cost analysis. Hospitals were randomised to one of three interventions: standard dissemination (SD of a guideline package, SD plus a web-based resource championed by an opinion leader, and SD plus plan-do-study-act (PDSA. The primary outcome was duration of fluid fast prior to induction of anaesthesia. Secondary outcomes included duration of food fast, patients’ experiences, and stakeholders’ experiences of implementation, including influences. ANOVA was used to test differences over time and interventions. Results Nineteen acute NHS hospitals participated. Across timepoints, 3,505 duration of fasting observations were recorded. No significant effect of the interventions was observed for either fluid or food fasting times. The effect size was 0.33 for the web-based intervention compared to SD alone for the change in fluid fasting and was 0.12 for PDSA compared to SD alone. The process evaluation showed different types of impact, including changes to practices, policies, and attitudes. A rich picture of the implementation challenges emerged, including inter-professional tensions and a lack of clarity for decision-making authority and responsibility. Conclusions This was a large, complex study and one of the first
Assessment of perinatal outcome after sustained tocolysis in early labour (APOSTEL-II trial
Directory of Open Access Journals (Sweden)
Scherjon Sicco A
2009-09-01
Full Text Available Abstract Background Preterm labour is the main cause of perinatal morbidity and mortality in the Western world. At present, there is evidence that tocolysis for 48 hours is useful in women with threatened preterm labour at least before 32 weeks. This allows transfer of the patient to a perinatal centre, and maximizes the effect of corticosteroids for improved neonatal survival. It is questionable whether treatment with tocolytics should be maintained after 48 hours. Methods/Design The APOSTEL II trial is a multicentre placebo-controlled study. Pregnant women admitted for threatened preterm labour who have been treated with 48 hours corticosteroids and tocolysis will be eligible to participate in the trial between 26+0 and 32+2 weeks gestational age. They will be randomly allocated to nifedipine (intervention or placebo (control for twelve days or until delivery, whatever comes first. Primary outcome is a composite of perinatal death, and severe neonatal morbidity up to evaluation at 6 months after birth. Secondary outcomes are gestational age at delivery, number of days in neonatal intensive care and total days of the first 6 months out of hospital. In addition a cost-effectiveness analysis will be performed. Analysis will be by intention to treat. The power calculation is based on an expected 11% difference in adverse neonatal outcome. This implies that 406 women have to be randomised (two sided test, β 0.2 at alpha 0.05. Discussion This trial will provide evidence as to whether maintenance tocolysis reduces severe perinatal morbidity and mortality in women with threatened preterm labour before 32 weeks. Trial Registration Clinical trial registration: http://www.trialregister.nl, NTR 1336, date of registration: June 3rd 2008.
DEFF Research Database (Denmark)
Handlos, Line Neerup; Chakraborty, Hrishikesh; Sen, Pranab Kumar
2009-01-01
To summarize and evaluate all publications including cluster-randomized trials used for maternal and child health research in developing countries during the last 10 years. METHODS: All cluster-randomized trials published between 1998 and 2008 were reviewed, and those that met our criteria...... for inclusion were evaluated further. The criteria for inclusion were that the trial should have been conducted in maternal and child health care in a developing country and that the conclusions should have been made on an individual level. Methods of accounting for clustering in design and analysis were......, and the trials generally improved in quality. CONCLUSIONS: Shortcomings exist in the sample-size calculations and in the analysis of cluster-randomized trials conducted during maternal and child health research in developing countries. Even though there has been improvement over time, further progress in the way...
Ayyildiz, Onder; Kucukevcilioglu, Murat; Ozge, Gokhan; Koylu, Mehmet Talay; Ozgonul, Cem; Gokce, Gokcen; Mumcuoglu, Tarkan; Durukan, Ali Hakan; Mutlu, Fatih Mehmet
2016-05-01
To compare peripapillary choroidal thickness (PP-CT) measurements using a spectral domain optical coherence tomography (SD-OCT) device with and without enhanced depth imaging (EDI). Sixty healthy subjects aged from 18 to 40 years were included in this study. PP-CTs were measured in the right eyes by manual segmentation via SD-OCT both with and without EDI. The intraclass correlation coefficient (ICC) for each technique and comparison of PP-CT measurements between two techniques were evaluated. The correlation between retinal nerve fiber layer (RNFL) thickness and PP-CT was also explored on images of SD-OCT without EDI. The PP-CT measurements of 55 subjects were evaluated. The ICC was 0.999 (95% CI: 0.998-1.0, p 0.05). Additionally, there was no correlation between RNFL thickness and PP-CT (r = -0.109; p = 0.335). The PP-CT measurements via SD-OCT without EDI were consistent with the measurements via SD-OCT with EDI. Ophthalmologists who do not have access to EDI technology can use images of SD-OCT without EDI to measure the peripapillary choroid for research purposes. However, thicker peripapillary choroids cannot be measured using this technique and require further modifications or newer technologies, such as SD-OCT with EDI.
Trial-based economic evaluations in occupational health: principles, methods, and recommendations.
van Dongen, Johanna M; van Wier, Marieke F; Tompa, Emile; Bongers, Paulien M; van der Beek, Allard J; van Tulder, Maurits W; Bosmans, Judith E
2014-06-01
To allocate available resources as efficiently as possible, decision makers need information on the relative economic merits of occupational health and safety (OHS) interventions. Economic evaluations can provide this information by comparing the costs and consequences of alternatives. Nevertheless, only a few of the studies that consider the effectiveness of OHS interventions take the extra step of considering their resource implications. Moreover, the methodological quality of those that do is generally poor. Therefore, this study aims to help occupational health researchers conduct high-quality trial-based economic evaluations by discussing the theory and methodology that underlie them, and by providing recommendations for good practice regarding their design, analysis, and reporting. This study also helps consumers of this literature with understanding and critically appraising trial-based economic evaluations of OHS interventions.
Rahn, Anne Christin; Köpke, Sascha; Kasper, Jürgen; Vettorazzi, Eik; Mühlhauser, Ingrid; Heesen, Christoph
2015-03-21
Multiple sclerosis is a chronic neurological condition usually starting in early adulthood and regularly leading to severe disability. Immunotherapy options are growing in number and complexity, while costs of treatments are high and adherence rates remain low. Therefore, treatment decision-making has become more complex for patients. Structured decision coaching, based on the principles of evidence-based patient information and shared decision-making, has the potential to facilitate participation of individuals in the decision-making process. This cluster randomised controlled trial follows the assumption that decision coaching by trained nurses, using evidence-based patient information and preference elicitation, will facilitate informed choices and induce higher decision quality, as well as better decisional adherence. The decision coaching programme will be evaluated through an evaluator-blinded superiority cluster randomised controlled trial, including 300 patients with suspected or definite relapsing-remitting multiple sclerosis, facing an immunotherapy decision. The clusters are 12 multiple sclerosis outpatient clinics in Germany. Further, the trial will be accompanied by a mixed-methods process evaluation and a cost-effectiveness study. Nurses in the intervention group will be trained in shared decision-making, coaching, and evidence-based patient information principles. Patients who meet the inclusion criteria will receive decision coaching (intervention group) with up to three face-to-face coaching sessions with a trained nurse (decision coach) or counselling as usual (control group). Patients in both groups will be given access to an evidence-based online information tool. The primary outcome is 'informed choice' after six months, assessed with the multi-dimensional measure of informed choice including the sub-dimensions risk knowledge (questionnaire), attitude concerning immunotherapy (questionnaire), and immunotherapy uptake (telephone survey
DEFF Research Database (Denmark)
Punthakee, Z; Bosch, J; Dagenais, G
2012-01-01
AIMS/OBJECTIVE: Conflicting data regarding cardiovascular effects of thiazolidinediones (TZDs) and extra-skeletal effects of vitamin D supported the need for a definitive trial. The Thiazolidinedione Intervention with vitamin D Evaluation (TIDE) trial aimed to assess the effects of TZDs (rosiglit......AIMS/OBJECTIVE: Conflicting data regarding cardiovascular effects of thiazolidinediones (TZDs) and extra-skeletal effects of vitamin D supported the need for a definitive trial. The Thiazolidinedione Intervention with vitamin D Evaluation (TIDE) trial aimed to assess the effects of TZDs...
Schroen, Anneke T; Petroni, Gina R; Wang, Hongkun; Gray, Robert; Wang, Xiaofei F; Cronin, Walter; Sargent, Daniel J; Benedetti, Jacqueline; Wickerham, Donald L; Djulbegovic, Benjamin; Slingluff, Craig L
2010-08-01
A major challenge for randomized phase III oncology trials is the frequent low rates of patient enrollment, resulting in high rates of premature closure due to insufficient accrual. We conducted a pilot study to determine the extent of trial closure due to poor accrual, feasibility of identifying trial factors associated with sufficient accrual, impact of redesign strategies on trial accrual, and accrual benchmarks designating high failure risk in the clinical trials cooperative group (CTCG) setting. A subset of phase III trials opened by five CTCGs between August 1991 and March 2004 was evaluated. Design elements, experimental agents, redesign strategies, and pretrial accrual assessment supporting accrual predictions were abstracted from CTCG documents. Percent actual/predicted accrual rate averaged per month was calculated. Trials were categorized as having sufficient or insufficient accrual based on reason for trial termination. Analyses included univariate and bivariate summaries to identify potential trial factors associated with accrual sufficiency. Among 40 trials from one CTCG, 21 (52.5%) trials closed due to insufficient accrual. In 82 trials from five CTCGs, therapeutic trials accrued sufficiently more often than nontherapeutic trials (59% vs 27%, p = 0.05). Trials including pretrial accrual assessment more often achieved sufficient accrual than those without (67% vs 47%, p = 0.08). Fewer exclusion criteria, shorter consent forms, other CTCG participation, and trial design simplicity were not associated with achieving sufficient accrual. Trials accruing at a rate much lower than predicted (accrual rate) were consistently closed due to insufficient accrual. This trial subset under-represents certain experimental modalities. Data sources do not allow accounting for all factors potentially related to accrual success. Trial closure due to insufficient accrual is common. Certain trial design factors appear associated with attaining sufficient accrual. Defining
Impact of copula directional specification on multi-trial evaluation of surrogate endpoints
Renfro, Lindsay A.; Shang, Hongwei; Sargent, Daniel J.
2014-01-01
Evaluation of surrogate endpoints using patient-level data from multiple trials is the gold standard, where multi-trial copula models are used to quantify both patient-level and trial-level surrogacy. While limited consideration has been given in the literature to copula choice (e.g., Clayton), no prior consideration has been given to direction of implementation (via survival versus distribution functions). We demonstrate that evenwith the “correct” copula family, directional misspecification leads to biased estimates of patient-level and trial-level surrogacy. We illustrate with a simulation study and a re-analysis of disease-free survival as a surrogate for overall survival in early stage colon cancer. PMID:24905465
Yu, Dan-Dan; Xie, Yan-Ming; Liao, Xing; Zhi, Ying-Jie; Jiang, Jun-Jie; Chen, Wei
2018-02-01
To evaluate the methodological quality and reporting quality of randomized controlled trials(RCTs) published in China Journal of Chinese Materia Medica, we searched CNKI and China Journal of Chinese Materia webpage to collect RCTs since the establishment of the magazine. The Cochrane risk of bias assessment tool was used to evaluate the methodological quality of RCTs. The CONSORT 2010 list was adopted as reporting quality evaluating tool. Finally, 184 RCTs were included and evaluated methodologically, of which 97 RCTs were evaluated with reporting quality. For the methodological evaluating, 62 trials(33.70%) reported the random sequence generation; 9(4.89%) trials reported the allocation concealment; 25(13.59%) trials adopted the method of blinding; 30(16.30%) trials reported the number of patients withdrawing, dropping out and those lost to follow-up;2 trials (1.09%) reported trial registration and none of the trial reported the trial protocol; only 8(4.35%) trials reported the sample size estimation in details. For reporting quality appraising, 3 reporting items of 25 items were evaluated with high-quality,including: abstract, participants qualified criteria, and statistical methods; 4 reporting items with medium-quality, including purpose, intervention, random sequence method, and data collection of sites and locations; 9 items with low-quality reporting items including title, backgrounds, random sequence types, allocation concealment, blindness, recruitment of subjects, baseline data, harms, and funding;the rest of items were of extremely low quality(the compliance rate of reporting item<10%). On the whole, the methodological and reporting quality of RCTs published in the magazine are generally low. Further improvement in both methodological and reporting quality for RCTs of traditional Chinese medicine are warranted. It is recommended that the international standards and procedures for RCT design should be strictly followed to conduct high-quality trials
Directory of Open Access Journals (Sweden)
Adriana Pucci Penteado de Faria e Silva
2011-11-01
Full Text Available RESUMO: Neste artigo, retomo brevemente a história da recepção de Problemas da poética de Dostoiévski, de Mikhail Bakhtin, no Brasil, estabelecendo alguns paralelos com aspectos da recepção da obra na Itália, na França e nos Estados Unidos, para, então, descrever os acréscimos da nova edição brasileira e analisar, considerando a relevância da obra para os estudos da linguagem, algumas modificações efetuadas pelo tradutor Paulo Bezerra na quarta edição da obra, lançada em 2008. ABSTRACT: In this article I briefly review the history of the Brazilian reception of Mikhail Bakhtin’s Problems of Dostoevsky’s Poetics, establishing a few parallels with aspects of this work’s reception in Italy, France, and the United States in order to describe the additions made to the new Brazilian edition and, considering the relevance of this work to Language Studies, analyze some changes proposed by translator Paulo Bezerra in its
A semi-automated tool for treatment plan-quality evaluation and clinical trial quality assurance
Wang, Jiazhou; Chen, Wenzhou; Studenski, Matthew; Cui, Yunfeng; Lee, Andrew J.; Xiao, Ying
2013-07-01
The goal of this work is to develop a plan-quality evaluation program for clinical routine and multi-institutional clinical trials so that the overall evaluation efficiency is improved. In multi-institutional clinical trials evaluating the plan quality is a time-consuming and labor-intensive process. In this note, we present a semi-automated plan-quality evaluation program which combines MIMVista, Java/MATLAB, and extensible markup language (XML). More specifically, MIMVista is used for data visualization; Java and its powerful function library are implemented for calculating dosimetry parameters; and to improve the clarity of the index definitions, XML is applied. The accuracy and the efficiency of the program were evaluated by comparing the results of the program with the manually recorded results in two RTOG trials. A slight difference of about 0.2% in volume or 0.6 Gy in dose between the semi-automated program and manual recording was observed. According to the criteria of indices, there are minimal differences between the two methods. The evaluation time is reduced from 10-20 min to 2 min by applying the semi-automated plan-quality evaluation program.
A semi-automated tool for treatment plan-quality evaluation and clinical trial quality assurance
International Nuclear Information System (INIS)
Wang, Jiazhou; Chen, Wenzhou; Studenski, Matthew; Cui, Yunfeng; Xiao, Ying; Lee, Andrew J
2013-01-01
The goal of this work is to develop a plan-quality evaluation program for clinical routine and multi-institutional clinical trials so that the overall evaluation efficiency is improved. In multi-institutional clinical trials evaluating the plan quality is a time-consuming and labor-intensive process. In this note, we present a semi-automated plan-quality evaluation program which combines MIMVista, Java/MATLAB, and extensible markup language (XML). More specifically, MIMVista is used for data visualization; Java and its powerful function library are implemented for calculating dosimetry parameters; and to improve the clarity of the index definitions, XML is applied. The accuracy and the efficiency of the program were evaluated by comparing the results of the program with the manually recorded results in two RTOG trials. A slight difference of about 0.2% in volume or 0.6 Gy in dose between the semi-automated program and manual recording was observed. According to the criteria of indices, there are minimal differences between the two methods. The evaluation time is reduced from 10–20 min to 2 min by applying the semi-automated plan-quality evaluation program. (note)
Schulz, Daniela N; Smit, Eline S; Stanczyk, Nicola E; Kremers, Stef P J; de Vries, Hein; Evers, Silvia M A A
2014-03-20
interventions were likely to be cost-effective when it concerned the lifestyle factor, whereas the control condition was when it concerned quality of life. However, there is no accepted cutoff point for the willingness to pay per gain in lifestyle behaviors, making it impossible to draw firm conclusions. Further economic evaluations of lifestyle interventions are needed. Dutch Trial Register NTR2168; http://www.trialregister.nl/trialreg/admin/rctview.asp?TC=2168 (Archived by WebCite at http://www.webcitation.org/6MbUqttYB).
Primary structure of segment 7 of the RNA of the influenza virus A/USSR/90/77 (HlNl)
International Nuclear Information System (INIS)
Samokhvalov, E.I.; Karginov, V.A.; Chizhikov, V.E.; Blinov, V.M.; Yuferov, V.P.; Vasilenko, S.K.; Uryvaev, L.V.; Zhdanov, V.M.
1986-01-01
The nucleotide sequence of segment 7 of the RNA of the influenza virus A/USSR/90/77 (HlNl) has been determined, and an analysis has been given of the nucleotide substitutions in comparison with known primary structures of segment 7 of other strains of the influenza virus. A hypothetical model of the secondary structure of segment 7 of the RNA of the influenza virus and a direct repeat both at the nucleotide level and at the amino acid level found in the center of the M 1 protein are discussed
The Australasian Resuscitation in Sepsis Evaluation (ARISE) trial statistical analysis plan.
Delaney, Anthony P; Peake, Sandra L; Bellomo, Rinaldo; Cameron, Peter; Holdgate, Anna; Howe, Belinda; Higgins, Alisa; Presneill, Jeffrey; Webb, Steve
2013-09-01
The Australasian Resuscitation in Sepsis Evaluation (ARISE) study is an international, multicentre, randomised, controlled trial designed to evaluate the effectiveness of early goal-directed therapy compared with standard care for patients presenting to the emergency department with severe sepsis. In keeping with current practice, and considering aspects of trial design and reporting specific to non-pharmacological interventions, our plan outlines the principles and methods for analysing and reporting the trial results. The document is prepared before completion of recruitment into the ARISE study, without knowledge of the results of the interim analysis conducted by the data safety and monitoring committee and before completion of the two related international studies. Our statistical analysis plan was designed by the ARISE chief investigators, and reviewed and approved by the ARISE steering committee. We reviewed the data collected by the research team as specified in the study protocol and detailed in the study case report form. We describe information related to baseline characteristics, characteristics of delivery of the trial interventions, details of resuscitation, other related therapies and other relevant data with appropriate comparisons between groups. We define the primary, secondary and tertiary outcomes for the study, with description of the planned statistical analyses. We have developed a statistical analysis plan with a trial profile, mock-up tables and figures. We describe a plan for presenting baseline characteristics, microbiological and antibiotic therapy, details of the interventions, processes of care and concomitant therapies and adverse events. We describe the primary, secondary and tertiary outcomes with identification of subgroups to be analysed. We have developed a statistical analysis plan for the ARISE study, available in the public domain, before the completion of recruitment into the study. This will minimise analytical bias and
International Nuclear Information System (INIS)
Widmann, E.; Eades, J.; Yamazaki, T.
1996-11-01
A precise scan of the previously discovered laser-induced transition (n,l) = (37,35) → (38,34) in p-barHe + revealed a doublet structure with a separation of Δν HF = 1.70 ± 0.05 GHz. This new type of 'hyperfine' splitting is ascribed to the interaction of the antiproton orbital angular momentum and the electron spin. (author)
An optimized cell culture-immunofluorescence (IFA) procedure, using the HCT-8 cell line, was evaluated in 'blind' trials to determine the sensitivity and reproducibility for measuring infectivity of flow cytometry prepared inocula of C. parvum oocysts. In separate trials, suspens...
Hansford, Lorraine; Sharkey, Siobhan; Edwards, Vanessa; Ukoumunne, Obioha; Byford, Sarah; Norwich, Brahm; Logan, Stuart; Ford, Tamsin
2015-02-10
The 'Supporting Teachers And childRen in Schools' (STARS) study is a cluster randomised controlled trial evaluating the Incredible Years Teacher Classroom Management (TCM) programme as a public health intervention. TCM is a 6 day training course delivered to groups of 8-12 teachers. The STARS trial will investigate whether TCM can improve children's behaviour, attainment and wellbeing, reduce teachers' stress and improve their self-efficacy. This protocol describes the methodology of the process evaluation embedded within the main trial, which aims to examine the uptake and implementation of TCM strategies within the classroom plus the wider school environment and improve the understanding of outcomes. The STARS trial will work with eighty teachers of children aged 4-9 years from eighty schools. Teachers will be randomised to attend the TCM course (intervention arm) or to "teach as normal" (control arm) and attend the course a year later. The process evaluation will use quantitative and qualitative approaches to assess fidelity to model, as well as explore headteachers' and teachers' experiences of TCM and investigate school factors that influence the translation of skills learnt to practice. Four of the eight groups of teachers (n = 40) will be invited to participate in focus groups within one month of completing the TCM course, and again a year later, while 45 of the 80 headteachers will be invited to take part in telephone interviews. Standardised checklists will be completed by group leaders and each training session will be videotaped to assess fidelity to model. Teachers will also complete standardised session evaluations. This study will provide important information about whether the Teacher Classroom Management course influences child and teacher mental health and well-being in both the short and long term. The process evaluation will provide valuable insights into factors that may facilitate or impede any impact. The trial has been registered with ISCTRN
Defendant's or convict's competency to stand trial - forensic psychiatric evaluation.
Cynkier, Przemysław N
2017-01-01
The purpose of this paper was to draw attention to particularly important aspects of pronouncing forensic psychiatric judgment regarding the accused or convicted individuals' competency to stand trial. The level of a person's mental capacity should be established using a structured psychiatric interview concerning a variety of aspects of a trial. Emphasis should be placed on evaluating the defendant's consciousness of the charges, knowledge of the potential punishment, ability to make significant decisions and be engaged in defense, knowledge about the role that particular people present in the courtroom play, understanding of the meaning of the evidence gathered in the case, the risk of aggression. The analysis should take into account the specificity of the mental disorder, the influence of proceedings on the course of disorder, as well as the presence of reactive disorders. Using testing tools by the expert can facilitate the process of evaluation to a certain degree. Forensic psychiatric evaluations can give rise to difficulties for the experts, what with the changing legal regulations and their interpretations. It would be justified to develop the standards of evaluation in this kind of cases, which would on the one hand apply to experts but which would also be respected by the judicial organ.
Evaluation of the Utility of a Discrete-Trial Functional Analysis in Early Intervention Classrooms
Kodak, Tiffany; Fisher, Wayne W.; Paden, Amber; Dickes, Nitasha
2013-01-01
We evaluated a discrete-trial functional analysis implemented by regular classroom staff in a classroom setting. The results suggest that the discrete-trial functional analysis identified a social function for each participant and may require fewer staff than standard functional analysis procedures.
Directory of Open Access Journals (Sweden)
Sorá Gustavo
1998-01-01
Full Text Available Este artigo analisa disputas e momentos de inflexão no processo de autonomização das ciências sociais e das estruturas de produção e circulação de mensagens escritas sobre o Brasil, a partir da análise da edição e recepção de Casa-grande & senzala, de Gilberto Freyre. Entre os sucessivos prefácios do livro, da 1ª à 14ª edições, e a consagração de autores como Florestan Fernandes, desenvolve-se uma prolongada e violenta batalha simbólica para universalizar as formas legítimas (estilos narrativos, projetos institucionais, fórmulas editoriais, invenção e representação de comunidades de leitores para pensar o Brasil. Seguindo este percurso, o artigo mostra como as representações que pesam sobre Freyre e seu livro de estréia, como regionalista, derivam tanto das posições e concepções que Freyre foi assumindo em sua trajetória, quanto das posições que foram se impondo no campo intelectual a partir dos anos 40 em São Paulo, com o objetivo de consolidar a "Sociologia científica e nacional". Somando à interpretação dos discursos os princípios de sua dispersão, como a edição e a institucionalização dos saberes universitários, o artigo busca compreender como livro e autor chegaram a ser o que são hoje em dia à luz de mudanças nos mecanismos de seleção do panteão dos intérpretes do Brasil.
DEFF Research Database (Denmark)
Lifson, A; Rhame, F; Bellosa, W
2006-01-01
adjudication between reviewers before diagnostic certainty was assigned. CONCLUSION: Important requirements for HIV trials using clinical endpoints include objective definitions of "confirmed" and "probable," a formal reporting process with adequate information and supporting source documentation, evaluation......PURPOSE: The processes for reporting and review of progression of HIV disease clinical endpoints are described for two large phase III international clinical trials. METHOD: SILCAAT and ESPRIT are multicenter randomized HIV trials evaluating the impact of interleukin-2 on disease progression...... and death in HIV-infected patients receiving antiretroviral therapy. We report definitions used for HIV progression of disease endpoints, procedures for site reporting of such events, processes for independent review of reported events by an Endpoint Review Committee (ERC), and the procedure...
Masterson-Algar, Patricia; Burton, Christopher R; Brady, Marian C; Nicoll, Avril; Clarke, Carl E; Rick, Caroline; Hughes, Max; Au, Pui; Smith, Christina H; Sackley, Catherine M
2017-08-29
The PD COMM trial is a phase III multi-centre randomised controlled trial whose aim is to evaluate the effectiveness and cost-effectiveness of two approaches to speech and language therapy (SLT) compared with no SLT intervention (control) for people with Parkinson's disease who have self-reported or carer-reported problems with their speech or voice. Our protocol describes the process evaluation embedded within the outcome evaluation whose aim is to evaluate what happened at the time of the PD COMM intervention implementation and to provide findings that will assist in the interpretation of the PD COMM trial results. Furthermore, the aim of the PD COMM process evaluation is to investigate intervention complexity within a theoretical model of how the trialled interventions might work best and why. Drawing from the Normalization Process Theory and frameworks for implementation fidelity, a mixed method design will be used to address process evaluation research questions. Therapists' and participants' perceptions and experiences will be investigated via in-depth interviews. Critical incident reports, baseline survey data from therapists, treatment record forms and home practice diaries also will be collected at relevant time points throughout the running of the PD COMM trial. Process evaluation data will be analysed independently of the outcome evaluation before the two sets of data are then combined. To date, there are a limited number of published process evaluation protocols, and few are linked to trials investigating rehabilitation therapies. Providing a strong theoretical framework underpinning design choices and being tailored to meet the complex characteristics of the trialled interventions, our process evaluation has the potential to provide valuable insight into which components of the interventions being delivered in PD COMM worked best (and what did not), how they worked well and why. ISRCTN Registry, ISRCTN12421382 . Registered on 18 April 2016.
International Nuclear Information System (INIS)
2007-07-01
The Environmental Investment Allowance (MIA), the Random Depreciation of Environmental Investments (VAMIL) and green investments entail fiscal costs that need ex-post evaluation based on the regulations of the RPE (ministerial regulation on performance measurement and evaluation). The aim of the evaluation was to describe the effectiveness of the policy instruments and their implementation. In addition to this basic objective a secondary objective was to provide insight in the expenditure of the means and to list improvement options. [mk] [nl
EIA and EINP. Evaluation study
International Nuclear Information System (INIS)
Lande, R.W.I. van der; De Vries, E.F.
2001-01-01
The evaluation study on the title subjects concerns two subsidy tools in the Netherlands: the Energy Investment Rebate (EIA, abbreviated in Dutch) and the Subsidy for Energy in the non-profit sector and other special sectors (EINP, abbreviated in Dutch). The central question in the evaluation was to what extent did the EIA and EINP contribute to the original policy targets and at what costs. The evaluation has been carried out by means of a desk study, interviews, and an analysis of bottlenecks and possible solutions. [nl
De Lorenzo, Antonino; Costacurta, Micaela; Merra, Giuseppe; Gualtieri, Paola; Cioccoloni, Giorgia; Marchetti, Massimiliano; Varvaras, Dimitrios; Docimo, Raffaella; Di Renzo, Laura
2017-06-10
Evidence of probiotics effects on gut function, brain activity and emotional behaviour were provided. Probiotics can have dramatic effects on behaviour through the microbiome-gut-brain axis, through vagus nerve. We investigated whether chronic probiotic intake could modulate psychological state, eating behaviour and body composition of normal weight obese (NWO) and preobese-obese (PreOB/OB) compared to normal weight lean women (NWL). 60 women were enrolled. At baseline and after a 3-week probiotic oral suspension (POS) intake, all subjects underwent evaluation of body composition by anthropometry and dual X-ray absorptiometry, and psychological profile assessment by self-report questionnaires (i.e. EDI-2, SCL90R and BUT). Statistical analysis was carried out using paired t test or a non-parametric Wilcoxon test to evaluate differences between baseline and after POS intake, one-way ANOVA to compare all three groups and, where applicable, Chi square or t test were used to assess symptoms. Of the 48 women that concluded the study, 24% were NWO, 26% were NWL and 50% were PreOB/OB. Significant differences in body composition were highlighted among groups both at baseline and after a POS (p women. At baseline and after POS intake, all subjects tested were negative to SCL90R_GSI scale, but after treatment subjects positive to BUT_GSI scale were significantly reduced (8.33%) (p women. Further research is needed on a larger population and for a longer period of treatment before definitive conclusions can be made. Trial registration ClinicalTrials.gov Id: NCT01890070.
The Sandia/Arzamas-16 Magazine-to-Magazine Remote Monitoring Field Trial Evaluation
International Nuclear Information System (INIS)
Barkanov, Boris; Blagin, Sergei; Croessmann, Dennis; Damico, Joe; Ehle, Steve; Nilsen, Curt
1999-01-01
Sandia National Laboratories and the Russian Federal Nuclear Center-All Russian Research Institute for Experimental Physics (VNIIEF) (also known as Arzamas-16) are collaborating on ways to assure the highest standards of safety, security, and international accountability of fissile material. For these collaborations, sensors and information technologies have been identified as important in reaching these standards in a cost-effective manner. Specifically, Sandia and VNIIEF have established a series of remote monitoring field trials to provide a mechanism for joint research and development on storage monitoring systems. These efforts consist of the ''Container-to-Container'', ''Magazine-to-Magazine'', and ''Facility-to-Facility'' field trials. This paper will describe the evaluation exercise Sandia and VNIIEF conducted on the Magazine-to-Magazine systems. Topics covered will include a description of the evaluation philosophy, how the various sensors and system features were tested, evaluation results, and lessons learned
Waterlander, Wilma E; de Boer, Michiel R; Schuit, Albertine J; Seidell, Jacob C; Steenhuis, Ingrid H M
2013-04-01
Reducing fruit and vegetable (F&V) prices is a frequently considered policy to improve dietary habits in the context of health promotion. However, evidence on the effectiveness of this intervention is limited. The objective was to examine the effects of a 50% price discount on F&Vs or nutrition education or a combination of both on supermarket purchases. A 6-mo randomized controlled trial within Dutch supermarkets was conducted. Regular supermarket shoppers were randomly assigned to 1 of 4 conditions: 50% price discounts on F&Vs, nutrition education, 50% price discounts plus nutrition education, or no intervention. A total of 199 participants provided baseline data; 151 (76%) were included in the final analysis. F&V purchases were measured by using supermarket register receipts at baseline, at 1 mo after the start of the intervention, at 3 mo, at 6 mo (end of the intervention period), and 3 mo after the intervention ended (9 mo). Adjusted multilevel models showed significantly higher F&V purchases (per household/2 wk) as a result of the price discount (+3.9 kg; 95% CI: 1.5, 6.3 kg) and the discount plus education intervention (+5.6 kg; 95% CI: 3.2, 7.9 kg) at 6 mo compared with control. Moreover, the percentage of participants who consumed recommended amounts of F&Vs (≥400 g/d) increased from 42.5% at baseline to 61.3% at 6 mo in both discount groups (P = 0.03). Education alone had no significant effect. Discounting F&Vs is a promising intervention strategy because it resulted in substantially higher F&V purchases, and no adverse effects were observed. Therefore, pricing strategies form an important focus for future interventions or policy. However, the long-term effects and the ultimate health outcomes require further investigation. This trial was registered at the ISRCTN Trial Register as number ISRCTN56596945 and at the Dutch Trial Register (http://www.trialregister.nl/trialreg/index.asp) as number NL22568.029.08.
Directory of Open Access Journals (Sweden)
Wendel Fajardo Reis
2016-09-01
Full Text Available http://dx.doi.org/10.5007/2175-7941.2016v33n2p462 O Ensino Médio pressupõe uma aprendizagem abrangente e significativa dos conteúdos, em que o professor deve valer-se de recursos didáticos disponíveis e adequados à sua prática. Nessa perspectiva, a atividade experimental torna-se um importante instrumento de ensino a ser explorado no estudo da Física, que também pode ser vivenciado pelos alunos por meio do livro didático (LD. Nesta pesquisa, realiza-se uma análise comparativa das atividades experimentais nas coleções de Física coincidentes nas edições de 2012 e 2015 do Programa Nacional do Livro Didático (PNLD. Para isso, aplica-se a classificação proposta por Barros (2009, fundamentada em competências e habilidades dos Parâmetros Curriculares Nacionais para o Ensino Médio (PCNEM (BRASIL, 1999 e nos temas estruturadores de suas orientações educacionais complementares (PCN+ (BRASIL, 2002. Os resultados mostram uma distribuição não uniforme dos experimentos nos temas da Física, em que ainda prevalecem os arranjos relacionados aos movimentos dos corpos. Para as categorias e dimensões de análise, verifica-se que os autores procuram evidenciar as competências e habilidades do PCNEM, entretanto os aspectos históricos sociais continuam pouco contemplados nas duas edições do Programa. Por fim, espera-se que as informações apresentadas nesse trabalho possam contribuir para a prática docente, com foco nas atividades experimentais dos livros didáticos de Física.
An open-label Optional Titration Trial to Evaluate the Efficacy ...
African Journals Online (AJOL)
An eight-week open-label optional titration trial to evaluate the efficacy, tolerability and safety of Valsartan 80 mg/ & 160 mg once daily was carried out in patients with mild to moderate essential hypertension at the Lagos University Teaching Hospital. There was a significant reduction in both systolic and diastolic blood ...
Zhao, Jun; Liao, Xing; Zhao, Hui; Li, Zhi-Geng; Wang, Nan-Yue; Wang, Li-Min
2016-11-01
To evaluate the methodological quality of the randomized controlled trials(RCTs) for traditional Chinese medicines for treatment of sub-health, in order to provide a scientific basis for the improvement of clinical trials and systematic review. Such databases as CNKI, CBM, VIP, Wanfang, EMbase, Medline, Clinical Trials, Web of Science and Cochrane Library were searched for RCTS for traditional Chinese medicines for treatment of sub-health between the time of establishment and February 29, 2016. Cochrane Handbook 5.1 was used to screen literatures and extract data, and CONSORT statement and CONSORT for traditional Chinese medicine statement were adopted as the basis for quality evaluation. Among the 72 RCTs included in this study, 67 (93.05%) trials described the inter-group baseline data comparability, 39(54.17%) trials described the unified diagnostic criteria, 28(38.89%) trials described the unified standards of efficacy, 4 (5.55%) trials mentioned the multi-center study, 19(26.38%) trials disclosed the random distribution method, 6(8.33%) trials used the random distribution concealment, 15(20.83%) trials adopted the method of blindness, 3(4.17%) study reported the sample size estimation in details, 5 (6.94%) trials showed a sample size of more than two hundred, 19(26.38%) trials reported the number of withdrawal, defluxion cases and those lost to follow-up, but only 2 trials adopted the ITT analysis,10(13.89%) trials reported the follow-up results, none of the trial reported the test registration and the test protocol, 48(66.7%) trials reported all of the indicators of expected outcomes, 26(36.11%) trials reported the adverse reactions and adverse events, and 4(5.56%) trials reported patient compliance. The overall quality of these randomized controlled trials for traditional Chinese medicines for treatment of sub-health is low, with methodological defects in different degrees. Therefore, it is still necessary to emphasize the correct application of principles
Experimental Evaluation of Fuzzy Logic Control of a Flexible Arm Manipulator
1993-12-09
linki -diag = [M-jinkld"iagI]; M-tipl.diag = O*ones(n 1); for i=2n-, M-tipl-diag(iji) = mtl*l1**2;... end M....tipl-diag(l,l) = mtl*(ohl+Hl)**2; M...M-jink lofC~diagl 1 = O*ones(nl~nl); for i= 2:nl-1,.... forj = i+1:nl,... M- linki -off-diagll(i,j) =(1I2)*ml1*11**2+(n1-j)*mll*11**2;... end end for...i = 2:nl,... M~ linki -off~diagl 1(1,1) =(1/2)*mll*(ohl+Il)*Il+(nl-i)*inil*(ohl+Il)*ll;... end Mjinkl~off..diagllI = MjIinkl~offjLiagl l+MjIinkl_off
Directory of Open Access Journals (Sweden)
Elisabeth Husabo
2017-06-01
Full Text Available Abstract Background It has been discussed whether the relationship between a patient on sick leave and his/her general practitioner (GP is too close, as this may hinder the GP’s objective evaluation of need for sick leave. Independent medical evaluation involves an independent physician consulting the patient. This could lead to new perspectives on sick leave and how to follow-up the patient. Methods/design The current study is a randomized controlled trial in a Norwegian primary care context, involving an effect evaluation, a cost/benefit analysis, and a qualitative evaluation. Independent medical evaluation will be compared to treatment as usual, i.e., the physicians’ and social insurance agencies’ current management of long-term sick-listed patients. Individuals aged 18–65 years, sick listed by their GP and on full or partial sick leave for the past 6 months in Hordaland county will be included. Exclusion criteria are pregnancy, cancer, dementia or an ICD-10 diagnosis. A total sample of 3800 will be randomly assigned to either independent medical evaluation or treatment as usual. Official register data will be used to measure the primary outcome; change in sickness benefits at 7, 9 and 12 months. Sick listed in other counties will serve as a second control group, if appropriate under the “common trend” assumption. Discussion The Norwegian effect evaluation of independent medical evaluation after 6 months sick leave is a large randomized controlled trial, and the first of its kind, to evaluate this type of intervention as a means of getting people back to work after long-term sickness absence. Trial registration ClinicalTrials.gov NCT02524392 . Registered June 23, 2015.
Evaluation of early efficacy endpoints for proof-of-concept trials.
Chen, Cong; Sun, Linda; Li, Chih-Lin
2013-03-11
A Phase II proof-of-concept (POC) trial usually uses an early efficacy endpoint other than a clinical endpoint as the primary endpoint. Because of the advancement in bioscience and technology, which has yielded a number of new surrogate biomarkers, drug developers often have more candidate endpoints to choose from than they can handle. As a result, selection of endpoint and its effect size as well as choice of type I/II error rates are often at the center of heated debates in design of POC trials. While optimization of the trade-off between benefit and cost is the implicit objective in such a decision-making process, it is seldom explicitly accounted for in practice. In this research note, motivated by real examples from the oncology field, we provide practical measures for evaluation of early efficacy endpoints (E4) for POC trials. We further provide optimal design strategies for POC trials that include optimal Go-No Go decision criteria for initiation of Phase III and optimal resource allocation strategies for conducting multiple POC trials in a portfolio under fixed resources. Although oncology is used for illustration purpose, the same idea developed in this research note also applies to similar situations in other therapeutic areas or in early-stage drug development in that a Go-No Go decision has to rely on limited data from an early efficacy endpoint and cost-effectiveness is the main concern.
Sheard, Laura; O'Hara, Jane; Armitage, Gerry; Wright, John; Cocks, Kim; McEachan, Rosemary; Watt, Ian; Lawton, Rebecca
2014-10-29
Estimates show that as many as one in 10 patients are harmed while receiving hospital care. Previous strategies to improve safety have focused on developing incident reporting systems and changing systems of care and professional behaviour, with little involvement of patients. The need to engage with patients about the quality and safety of their care has never been more evident with recent high profile reviews of poor hospital care all emphasising the need to develop and support better systems for capturing and responding to the patient perspective on their care. Over the past 3 years, our research team have developed, tested and refined the PRASE (Patient Reporting and Action for a Safe Environment) intervention, which gains patient feedback about quality and safety on hospital wards. A multi-centre, cluster, wait list design, randomised controlled trial with an embedded qualitative process evaluation. The aim is to assess the efficacy of the PRASE intervention, in achieving patient safety improvements over a 12-month period.The trial will take place across 32 hospital wards in three NHS Hospital Trusts in the North of England. The PRASE intervention comprises two tools: (1) a 44-item questionnaire which asks patients about safety concerns and issues; and (2) a proforma for patients to report (a) any specific patient safety incidents they have been involved in or witnessed and (b) any positive experiences. These two tools then provide data which are fed back to wards in a structured feedback report. Using this report, ward staff are asked to hold action planning meetings (APMs) in order to action plan, then implement their plans in line with the issues raised by patients in order to improve patient safety and the patient experience.The trial will be subjected to a rigorous qualitative process evaluation which will enable interpretation of the trial results. fieldworker diaries, ethnographic observation of APMs, structured interviews with APM lead and collection
Baudart, Marie; Ravaud, Philippe; Baron, Gabriel; Dechartres, Agnes; Haneef, Romana; Boutron, Isabelle
2016-01-28
Observational studies are essential for assessing safety. The aims of this study were to evaluate whether results of observational studies evaluating an intervention with safety outcome(s) registered at ClinicalTrials.gov were published and, if not, whether they were available through posting on ClinicalTrials.gov or the sponsor website. We identified a cohort of observational studies with safety outcome(s) registered on ClinicalTrials.gov after October 1, 2007, and completed between October 1, 2007, and December 31, 2011. We systematically searched PubMed for a publication, as well as ClinicalTrials.gov and the sponsor website for results. The main outcomes were the time to the first publication in journals and to the first public availability of the study results (i.e. published or posted on ClinicalTrials.gov or the sponsor website). For all studies with results publicly available, we evaluated the completeness of reporting (i.e. reported with the number of events per arm) of safety outcomes. We identified 489 studies; 334 (68%) were partially or completely funded by industry. Results for only 189 (39%, i.e. 65% of the total target number of participants) were published at least 30 months after the study completion. When searching other data sources, we obtained the results for 53% (n = 158; i.e. 93% of the total target number of participants) of unpublished studies; 31% (n = 94) were posted on ClinicalTrials.gov and 21% (n = 64) on the sponsor website. As compared with non-industry-funded studies, industry-funded study results were less likely to be published but not less likely to be publicly available. Of the 242 studies with a primary outcome recorded as a safety issue, all these outcomes were adequately reported in 86% (114/133) when available in a publication, 91% (62/68) when available on ClinicalTrials.gov, and 80% (33/41) when available on the sponsor website. Only 39% of observational studies evaluating an intervention with safety outcome
Sasaki, T.; Azuma, S.; Matsuda, S.; Nagayama, A.; Ogido, M.; Saito, H.; Hanafusa, Y.
2016-12-01
The Japan Agency for Marine-Earth Science and Technology (JAMSTEC) archives a large amount of deep-sea research videos and photos obtained by JAMSTEC's research submersibles and vehicles with cameras. The web site "JAMSTEC E-library of Deep-sea Images : J-EDI" (http://www.godac.jamstec.go.jp/jedi/e/) has made videos and photos available to the public via the Internet since 2011. Users can search for target videos and photos by keywords, easy-to-understand icons, and dive information at J-EDI because operating staffs classify videos and photos as to contents, e.g. living organism and geological environment, and add comments to them.Dive survey data including videos and photos are not only valiant academically but also helpful for education and outreach activities. With the aim of the improvement of visibility for broader communities, we added new functions of 3-dimensional display synchronized various dive survey data with videos in this year.New Functions Users can search for dive survey data by 3D maps with plotted dive points using the WebGL virtual map engine "Cesium". By selecting a dive point, users can watch deep-sea videos and photos and associated environmental data, e.g. water temperature, salinity, rock and biological sample photos, obtained by the dive survey. Users can browse a dive track visualized in 3D virtual spaces using the WebGL JavaScript library. By synchronizing this virtual dive track with videos, users can watch deep-sea videos recorded at a point on a dive track. Users can play an animation which a submersible-shaped polygon automatically traces a 3D virtual dive track and displays of dive survey data are synchronized with tracing a dive track. Users can directly refer to additional information of other JAMSTEC data sites such as marine biodiversity database, marine biological sample database, rock sample database, and cruise and dive information database, on each page which a 3D virtual dive track is displayed. A 3D visualization of a dive
Jennings, Natasha; Gardner, Glenn; O'Reilly, Gerard
2014-09-01
To evaluate emergency nurse practitioner service effectiveness on outcomes related to quality of care and service responsiveness. Increasing service pressures in the emergency setting have resulted in the adoption of service innovation models; the most common and rapidly expanding of these is the emergency nurse practitioner. The delivery of high quality patient care in the emergency department is one of the most important service indicators to be measured in health services today. The rapid uptake of emergency nurse practitioner service in Australia has outpaced the capacity to evaluate this model in outcomes related to safety and quality of patient care. Pragmatic randomized controlled trial at one site with 260 participants. This protocol describes a definitive prospective randomized controlled trial, which will examine the impact of emergency nurse practitioner service on key patient care and service indicators. The study control will be standard emergency department care. The intervention will be emergency nurse practitioner service. The primary outcome measure is pain score reduction and time to analgesia. Secondary outcome measures are waiting time, number of patients who did not wait, length of stay in the emergency department and representations within 48 hours. Scant research enquiry evaluating emergency nurse practitioner service on patient effectiveness and service responsiveness exists currently. This study is a unique trial that will test the effectiveness of the emergency nurse practitioner service on patients who present to the emergency department with pain. The research will provide an opportunity to further evaluate emergency nurse practitioner models of care and build research capacity into the workforce. Trial registration details: Australian and New Zealand Clinical Trials Registry dated 18th August 2013, ACTRN12613000933752. © 2014 John Wiley & Sons Ltd.
A randomised controlled trial evaluating family mediated exercise (FAME therapy following stroke
Directory of Open Access Journals (Sweden)
Stokes Emma
2008-06-01
Full Text Available Abstract Background Stroke is a leading cause of disability among adults worldwide. Evidence suggests that increased duration of exercise therapy following stroke has a positive impact on functional outcome following stroke. The main objective of this randomised controlled trial is to evaluate the impact of additional family assisted exercise therapy in people with acute stroke. Methods/Design A prospective multi-centre single blind randomised controlled trial will be conducted. Forty patients with acute stroke will be randomised into either an experimental or control group. The experimental group will receive routine therapy and additional lower limb exercise therapy in the form of family assisted exercises. The control group will receive routine therapy with no additional formal input from their family members. Participants will be assessed at baseline, post intervention and followed up at three months using a series of standardised outcome measures. A secondary aim of the project is to evaluate the impact of the family mediated exercise programme on the person with stroke and the individual(s assisting in the delivery of exercises using a qualitative methodology. The study has gained ethical approval from the Research Ethics Committees of each of the clinical sites involved in the study. Discussion This study will evaluate a structured programme of exercises that can be delivered to people with stroke by their 'family members/friends'. Given that the progressive increase in the population of older people is likely to lead to an increased prevalence of stroke in the future, it is important to reduce the burden of this illness on the individual, the family and society. Family mediated exercises can maximise the carry over outside formal physiotherapy sessions, giving patients the opportunity for informal practice. Trial Registration The protocol for this study is registered with the US NIH Clinical trials registry (NCT00666744
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Julie A Luker
2016-05-01
Full Text Available Abstract Background The implementation of multidisciplinary stroke rehabilitation interventions is challenging, even when the intervention is evidence-based. Very little is known about the implementation of complex interventions in rehabilitation clinical trials. The aim of study was to better understand how the implementation of a rehabilitation intervention in a clinical trial within acute stroke units is experienced by the staff involved. This qualitative process evaluation was part of a large Phase III stroke rehabilitation trial (AVERT. Methods A descriptive qualitative approach was used. We purposively sampled 53 allied health and nursing staff from 19 acute stroke units in Australia, New Zealand and Scotland. Semi-structured interviews were conducted by phone, voice-internet, or face to face. Digitally recorded interviews were transcribed and analysed by two researchers using rigorous thematic analysis. Results Our analysis uncovered ten important themes that provide insight into the challenges of implementing complex new rehabilitation practices within complex care settings, plus factors and strategies that assisted implementation. Themes were grouped into three main categories: staff experience of implementing the trial intervention, barriers to implementation, and overcoming the barriers. Participation in the trial was challenging but had personal rewards and improved teamwork at some sites. Over the years that the trial ran some staff perceived a change in usual care. Barriers to trial implementation at some sites included poor teamwork, inadequate staffing, various organisational barriers, staff attitudes and beliefs, and patient-related barriers. Participants described successful implementation strategies that were built on interdisciplinary teamwork, education and strong leadership to ‘get staff on board’, and developing different ways of working. Conclusions The AVERT stroke rehabilitation trial required commitment to deliver
Kistler, Kristin D; Xu, Yingxin; Zou, Kelly H; Ntanios, Fady; Chapman, Douglass S; Luo, Xuemei
2018-01-01
Overactive bladder (OAB) disproportionately affects older-aged adults, yet most randomized controlled trials (RCTs) underrepresent patients ≥65. This systematic literature review (SLR) identified RCTs evaluating β-3 adrenergic agonists or muscarinic antagonists in elderly patients with OAB, and compared study quality across trials. MEDLINE ® , Embase ® , and Cochrane Collaboration Central Register of Clinical Trials databases were searched from inception through April 28, 2015 to identify published, peer-reviewed RCT reports evaluating β-3 adrenergic agonists or muscarinic antagonists in elderly OAB patients (either ≥65 years or study-described as "elderly"). To assess study quality of RCT reports, we focused on internal/external validity, assessed via two scales: the validated Effective Public Health Practice Project [EPHPP]): Quality Assessment Tool for Quantitative Studies, and a tool commissioned by the Agency for Healthcare Research and Quality (AHRQ). Database searches yielded 1380 records that were then screened according to predefined inclusion/exclusion criteria. We included eight papers meeting study criteria. Despite scientific community efforts to improve RCT reporting standards, published reports still include incomplete and inconsistent reporting-of subject attrition, baseline patient characteristics, inclusion/exclusion criteria, and other important details. Only three of the eight OAB RCTs in this review received quality ratings of Strong (EPHPP) or Fair (AHRQ) and were multicenter with large samples. Despite the prevalence of OAB among older age individuals, relatively few RCTs evaluate OAB treatments explicitly among elderly subjects. The findings from this quality assessment suggest some areas for improvement in both conduct and reporting of future RCTs assessing OAB treatment in elderly. © 2017 Wiley Periodicals, Inc.
Type 1 Diabetes TrialNet--an international collaborative clinical trials network.
Skyler, Jay S; Greenbaum, Carla J; Lachin, John M; Leschek, Ellen; Rafkin-Mervis, Lisa; Savage, Peter; Spain, Lisa
2008-12-01
Type 1 Diabetes TrialNet is an international consortium of clinical research centers aimed at the prevention or delay of type 1 diabetes (T1D). The fundamental goal of TrialNet is to counter the T1D disease process by immune modulation and/or enhancement of beta cell proliferation and regeneration. To achieve this goal, TrialNet researchers are working to better understand the natural history of the disease, to identify persons at risk, and to clinically evaluate novel therapies that balance potential risks and benefits. The particular focus is on studies of preventive measures. In addition, TrialNet evaluates therapies in individuals with newly diagnosed T1D with preserved beta cell function to help determine the risk/benefit profile and gain an initial assessment of potential efficacy in preservation of beta cell function, so that promising agents can be studied in prevention trials. In addition, TrialNet evaluates methodologies that enhance the conduct of its clinical trials, which includes tests of outcome assessment methodology, the evaluation of surrogate markers, and mechanistic studies laying the foundation for future clinical trials.
Effect of fusarium wilt disease on seed yield of advance lentil genotypes
International Nuclear Information System (INIS)
Sarwar, G.; Asghar, M.J.; Abbas, G.; Akhtar, K.P.
2014-01-01
Wilt caused by Fusarium oxysporum is considered as the most damaging soil disease of lentil. Current study was carried out to see the effect of Fusarium wilt disease on seed yield of advance lentil genotypes in wilt sick plot. Fourteen entries were tested in national yield uniform trial (NUYT), 11 in adaptation yield trial (AYT), 15 in advance line yield trial-I (ALYT-I), 12 in advance line yield trial-II (ALYT-II) and 25 in preliminary yield trial (PYT) along with standard check. Mean seed yields of 891.04, 1281.78, 1153.81, 1080.04 and 789.45 kg ha/sup -1/were observed in NUYT, AYT, ALYT-I, ALYT-II and PYT, respectively. The average disease intensity in various trials was more than 30%. Disease severity was less than 10% in nine genotypes. This was also confirmed by high negative values of their losses over check. Out of these, the genotypes, 03501, NL 96625, NL 66184, NL 66106 and NL 31742/03 produced highest seed yield of 2945 kg ha/sup -1/, 2667 kg ha/sup -1/, 2490 kg ha/sup -1/,2390 kg ha/sup -1/and 2691 kg ha/sup -1/ respectively. The higher yield may be attributed to inbuilt resistance against such a drastic disease. Overall, seed yield and disease incidence were negatively correlated in all yield trials. The genotypes under severe wilt attack produced no seed yield. It is clear from this study that resistance/tolerance is available in lentil that can be selected based on high yield potential along with minimum yield losses for further breeding. (author)
Luker, Julie A; Craig, Louise E; Bennett, Leanne; Ellery, Fiona; Langhorne, Peter; Wu, Olivia; Bernhardt, Julie
2016-05-10
The implementation of multidisciplinary stroke rehabilitation interventions is challenging, even when the intervention is evidence-based. Very little is known about the implementation of complex interventions in rehabilitation clinical trials. The aim of study was to better understand how the implementation of a rehabilitation intervention in a clinical trial within acute stroke units is experienced by the staff involved. This qualitative process evaluation was part of a large Phase III stroke rehabilitation trial (AVERT). A descriptive qualitative approach was used. We purposively sampled 53 allied health and nursing staff from 19 acute stroke units in Australia, New Zealand and Scotland. Semi-structured interviews were conducted by phone, voice-internet, or face to face. Digitally recorded interviews were transcribed and analysed by two researchers using rigorous thematic analysis. Our analysis uncovered ten important themes that provide insight into the challenges of implementing complex new rehabilitation practices within complex care settings, plus factors and strategies that assisted implementation. Themes were grouped into three main categories: staff experience of implementing the trial intervention, barriers to implementation, and overcoming the barriers. Participation in the trial was challenging but had personal rewards and improved teamwork at some sites. Over the years that the trial ran some staff perceived a change in usual care. Barriers to trial implementation at some sites included poor teamwork, inadequate staffing, various organisational barriers, staff attitudes and beliefs, and patient-related barriers. Participants described successful implementation strategies that were built on interdisciplinary teamwork, education and strong leadership to 'get staff on board', and developing different ways of working. The AVERT stroke rehabilitation trial required commitment to deliver an intervention that needed strong collaboration between nurses and
Mann, Cindy; Delgado, Debbie; Horwood, Jeremy
2014-04-01
A discussion and qualitative evaluation of the use of peer-review to train nurses and optimize recruitment practice in a randomized controlled trial. Sound recruitment processes are critical to the success of randomized controlled trials. Nurses recruiting to trials must obtain consent for an intervention that is administered for reasons other than anticipated benefit to the patient. This requires not only patients' acquiescence but also evidence that they have weighed the relevant information in reaching their decision. How trial information is explained is vital, but communication and training can be inadequate. A discussion of a new process to train nurses recruiting to a randomized controlled trial. Literature from 1999-2013 about consenting to trials is included. Over 3 months from 2009-2010, recruiting nurses reviewed recruitment interviews recorded during the pilot phase of a single-site randomized controlled trial and noted content, communication style and interactions. They discussed their findings during peer-review meetings, which were audio-recorded and analysed using qualitative methodology. Peer-review can enhance nurses' training in trial recruitment procedures by supporting development of the necessary communication skills, facilitating consistency in information provision and sharing best practice. Nurse-led peer-review can provide a forum to share communication strategies that will elicit and address participant concerns and obtain evidence of participant understanding prior to consent. Comparing practice can improve consistency and accuracy of trial information and facilitate identification of recruitment issues. Internal peer-review was well accepted and promoted team cohesion. Further evaluation is needed. © 2013 John Wiley & Sons Ltd.
Directory of Open Access Journals (Sweden)
Kenyon Sara
2010-07-01
Full Text Available Abstract Managing clinical trials, of whatever size and complexity, requires efficient trial management. Trials fail because tried and tested systems handed down through apprenticeships have not been documented, evaluated or published to guide new trialists starting out in this important field. For the past three decades, trialists have invented and reinvented the trial management wheel. We suggest that to improve the successful, timely delivery of important clinical trials for patient benefit, it is time to produce standard trial management guidelines and develop robust methods of evaluation.
Zaman, AnneClaire G N M; Tytgat, Kristien M A J; Klinkenbijl, Jean H G; Frings-Dresen, Monique H W; de Boer, Angela G E M
2016-05-10
Gastrointestinal (GI) cancer is frequently diagnosed in people of working age, and many GI cancer patients experience work-related problems. Although these patients often experience difficulties returning to work, supportive work-related interventions are lacking. We have therefore developed a tailored work-related support intervention for GI cancer patients, and we aim to evaluate its cost-effectiveness compared with the usual care provided. If this intervention proves effective, it can be implemented in practice to support GI cancer patients after diagnosis and to help them return to work. We designed a multicentre randomized controlled trial with a follow-up of twelve months. The study population (N = 310) will include individuals aged 18-63 years diagnosed with a primary GI cancer and employed at the time of diagnosis. The participants will be randomized to the intervention or to usual care. 'Usual care' is defined as psychosocial care in which work-related issues are not discussed. The intervention group will receive tailored work-related support consisting of three face-to-face meetings of approximately 30 min each. Based on the severity of their work-related problems, the intervention group will be divided into groups receiving three types of support (A, B or C). A different supportive healthcare professional will be available for each group: an oncological nurse (A), an oncological occupational physician (B) and a multidisciplinary team (C) that includes an oncological nurse, oncological occupational physician and treating oncologist/physician. The primary outcome measure is return to work (RTW), defined as the time to a partial or full RTW. The secondary outcomes are work ability, work limitations, quality of life, and direct and indirect costs. The hypothesis is that tailored work-related support for GI cancer patients is more effective than usual care in terms of the RTW. The intervention is innovative in that it combines oncological and
Directory of Open Access Journals (Sweden)
Nuno Medeiros
2010-12-01
Full Text Available Localizada, desde o início das diligências explicativas para a apreender, numa matriz temática e disciplinar em que se multiplicam os cruzamentos, a edição de livros foi sendo construída como objeto para cuja captura e definição convergiu e converge sinuosamente um feixe de tradições e perspectivas, tanto na sociologia como na história. Este artigo procura estabelecer um percurso sistematizado que se possa constituir para o leitor interessado como baliza de entendimento de um campo de pesquisa teórica e empírica em construção, que aqui se denomina "sociologia histórica da edição". Projeto necessariamente parcelar, o propósito apresentado concretiza-se seletivamente, tentando proceder a uma exploração do tema a partir especificamente de duas tradições, a francesa e a anglo-saxônica, com enfoque particular na produção do último meio século.Since the first attempts to apprehend and explain the phenomenon, book publishing has been apprehended within a disciplinary and thematic context formed by a constellation of traditions and approaches in both sociology and history with multiple interconnections. This article looks to provide a systematic framework for the reader interested in gaining an understanding of one particular field of theoretical and empirical research, what I call here a historical sociology of publishing. A necessarily incomplete project, the approach is purposefully selective, examining the theme through the exploration of two specific traditions, French and Anglo-Saxon, with a particular focus on the last half century.
The evaluation of a trial of syringe vending machines in Canberra, Australia.
McDonald, David
2009-07-01
Syringe vending machines (SVMs) have been trialled in Canberra, Australian Capital Territory, Australia, as an intervention aiming to increase the availability of sterile injecting equipment for use by IDUs. This study evaluated the 12-month trial. A utilisation-focused evaluation model, with both formative and summative components, was employed. Four SVMs were installed, each dispensing packs containing four 1 mL syringes and associated injecting paraphernalia. The trial participants were the clients of the SVMs and other key informants. The core measurements used were the number of syringes dispensed in Canberra by SVMs and other outlets, SVM clients' demographics and experiences of and attitudes towards SVMs, perceived impacts of SVMs on needle sharing, unsafe disposal of used syringes in the vicinity of SVMs, and community and stakeholder attitudes. The trial was implemented successfully, with no adverse consequences identified. The SVMs appear to be serving both the usual clients of the other outlets for sterile injecting equipment (community pharmacies and the Needle Syringe Program outlets) and others who are reluctant to use such outlets or find them inconvenient. The out-of-business-hours provision of syringes through the SVMs was particularly welcomed by both SVM clients and other stakeholders. The continuing operation of the initial four SVMs is widely supported, and additional machines are requested by clients and others. Owing to the success of the trial in terms of feasibility and outcomes for both IDUs and for the broader community, it is desirable that providing sterile injecting equipment through SVMs continues and be expanded as an integral component of harm reduction strategies.
International Nuclear Information System (INIS)
Sueoka-Aragane, Naoko; Kobayashi, Naomi; Bonnard, Eric; Charbonnier, Colette; Yamamichi, Junta; Mizobe, Hideaki; Kimura, Shinya
2015-01-01
Although tumor response evaluated with radiological imaging is frequently used as a primary endpoint in clinical trials, it is difficult to obtain precise results because of inter- and intra-observer differences. To evaluate usefulness of a cloud-based local-read paradigm implementing software solutions that standardize imaging evaluations among international investigator sites for clinical trials of lung cancer. Two studies were performed: KUMO I and KUMO I Extension. KUMO I was a pilot study aiming at demonstrating the feasibility of cloud implementation and identifying issues regarding variability of evaluations among sites. Chest CT scans at three time-points from baseline to progression, from 10 patients with lung cancer who were treated with EGFR tyrosine kinase inhibitors, were evaluated independently by two oncologists (Japan) and one radiologist (France), through a cloud-based software solution. The KUMO I Extension was performed based on the results of KUMO I. KUMO I showed discordance rates of 40% for target lesion selection, 70% for overall response at the first time-point, and 60% for overall response at the second time-point. Since the main reason for the discordance was differences in the selection of target lesions, KUMO I Extension added a cloud-based quality control service to achieve a consensus on the selection of target lesions, resulting in an improved rate of agreement of response evaluations. The study shows the feasibility of imaging evaluations at investigator sites, based on cloud services for clinical studies involving multiple international sites. This system offers a step forward in standardizing evaluations of images among widely dispersed sites
An algorithm for evaluating the ethics of a placebo-controlled trial.
Amdur, R J; Biddle, C J
2001-10-20
The purpose of this article is to clarify the decision points that are important to consider when evaluating the ethics of a placebo-controlled trial. The ethical requirements for research involving human subjects are reviewed, and the rationale for and potential problems with concomitant placebo control are explained. A series of case discussions are used to illustrate each decision point. The critical decision points in the evaluation of the ethics of a placebo-controlled trial are as follows: (i) Is placebo being used in place of standard therapy? (ii) Is standard therapy likely to be effective? (iii) Is the toxicity of standard therapy such that patients routinely refuse this treatment? (iv) Could the use of placebo result in severe suffering or irreversible harm? (v) Is the variability in the placebo response such that it is reasonable to consider other options for the control group? (vi) Would a reasonable person with an average degree of altruism and risk aversiveness agree to participate in this study? The algorithm presented in this article gives researchers and research monitors (such as Institutional Review Board members) the tools they need to evaluate the ethics of a study that uses concomitant placebo control. Copyright 2001 Wiley-Liss, Inc.
Directory of Open Access Journals (Sweden)
Naomi L. Forrester
2014-11-01
Full Text Available In the original manuscript, Forrester, N.L.; Coffey, L.L.; Weaver, S.C. Arboviral Bottlenecks and Challenges to Maintaining Diversity and Fitness during Mosquito Transmission. Viruses 2014, 6, 3991–4004, Figure 1 contains an error, the third bottle was absent from the figure:[...
Likelihood-based methods for evaluating principal surrogacy in augmented vaccine trials.
Liu, Wei; Zhang, Bo; Zhang, Hui; Zhang, Zhiwei
2017-04-01
There is growing interest in assessing immune biomarkers, which are quick to measure and potentially predictive of long-term efficacy, as surrogate endpoints in randomized, placebo-controlled vaccine trials. This can be done under a principal stratification approach, with principal strata defined using a subject's potential immune responses to vaccine and placebo (the latter may be assumed to be zero). In this context, principal surrogacy refers to the extent to which vaccine efficacy varies across principal strata. Because a placebo recipient's potential immune response to vaccine is unobserved in a standard vaccine trial, augmented vaccine trials have been proposed to produce the information needed to evaluate principal surrogacy. This article reviews existing methods based on an estimated likelihood and a pseudo-score (PS) and proposes two new methods based on a semiparametric likelihood (SL) and a pseudo-likelihood (PL), for analyzing augmented vaccine trials. Unlike the PS method, the SL method does not require a model for missingness, which can be advantageous when immune response data are missing by happenstance. The SL method is shown to be asymptotically efficient, and it performs similarly to the PS and PL methods in simulation experiments. The PL method appears to have a computational advantage over the PS and SL methods.
2010-07-01
... EDIS shall ensure that a qualified medical authority conducts or verifies a medical evaluation for use... to the questions posed in the original referral. The written report shall include: (i) Demographic... initial parental permission, EDIS must: (i) Obtain parental permission for the additional activities. (ii...
Husabo, Elisabeth; Monstad, Karin; Holmås, Tor Helge; Oyeflaten, Irene; Werner, Erik L; Maeland, Silje
2017-06-14
It has been discussed whether the relationship between a patient on sick leave and his/her general practitioner (GP) is too close, as this may hinder the GP's objective evaluation of need for sick leave. Independent medical evaluation involves an independent physician consulting the patient. This could lead to new perspectives on sick leave and how to follow-up the patient. The current study is a randomized controlled trial in a Norwegian primary care context, involving an effect evaluation, a cost/benefit analysis, and a qualitative evaluation. Independent medical evaluation will be compared to treatment as usual, i.e., the physicians' and social insurance agencies' current management of long-term sick-listed patients. Individuals aged 18-65 years, sick listed by their GP and on full or partial sick leave for the past 6 months in Hordaland county will be included. Exclusion criteria are pregnancy, cancer, dementia or an ICD-10 diagnosis. A total sample of 3800 will be randomly assigned to either independent medical evaluation or treatment as usual. Official register data will be used to measure the primary outcome; change in sickness benefits at 7, 9 and 12 months. Sick listed in other counties will serve as a second control group, if appropriate under the "common trend" assumption. The Norwegian effect evaluation of independent medical evaluation after 6 months sick leave is a large randomized controlled trial, and the first of its kind, to evaluate this type of intervention as a means of getting people back to work after long-term sickness absence. ClinicalTrials.gov NCT02524392 . Registered June 23, 2015.
How to Evaluate Phase Differences between Trial Groups in Ongoing Electrophysiological Signals
VanRullen, Rufin
2016-01-01
A growing number of studies endeavor to reveal periodicities in sensory and cognitive functions, by comparing the distribution of ongoing (pre-stimulus) oscillatory phases between two (or more) trial groups reflecting distinct experimental outcomes. A systematic relation between the phase of spontaneous electrophysiological signals, before a stimulus is even presented, and the eventual result of sensory or cognitive processing for that stimulus, would be indicative of an intrinsic periodicity in the underlying neural process. Prior studies of phase-dependent perception have used a variety of analytical methods to measure and evaluate phase differences, and there is currently no established standard practice in this field. The present report intends to remediate this need, by systematically comparing the statistical power of various measures of “phase opposition” between two trial groups, in a number of real and simulated experimental situations. Seven measures were evaluated: one parametric test (circular Watson-Williams test), and three distinct measures of phase opposition (phase bifurcation index, phase opposition sum, and phase opposition product) combined with two procedures for non-parametric statistical testing (permutation, or a combination of z-score and permutation). While these are obviously not the only existing or conceivable measures, they have all been used in recent studies. All tested methods performed adequately on a previously published dataset (Busch et al., 2009). On a variety of artificially constructed datasets, no single measure was found to surpass all others, but instead the suitability of each measure was contingent on several experimental factors: the time, frequency, and depth of oscillatory phase modulation; the absolute and relative amplitudes of post-stimulus event-related potentials for the two trial groups; the absolute and relative trial numbers for the two groups; and the number of permutations used for non-parametric testing
Acosta, Joie D.; Chinman, Matthew; Ebener, Patricia; Phillips, Andrea; Xenakis, Lea; Malone, Patrick S.
2016-01-01
Restorative practices in schools lack rigorous evaluation studies. As an example of rigorous school-based research, this article describes the first randomized control trial of restorative practices to date, the Study of Restorative Practices. It is a 5-year, cluster-randomized controlled trial (RCT) of the Restorative Practices Intervention (RPI)…
Directory of Open Access Journals (Sweden)
Lucian Hritcu
2007-12-01
Full Text Available The effects of lesioning the ventral tegmental area or substantia nigra pars reticulata by means of bilateral microinjections of two doses of kainic acid (50 ng/250 nl and 100 ng/500 nl were investigated to clarify the role of the mesotelencephalic dopamine system in learning and memory processes. Our findings suggest that ventral tegmental area and substantia nigra dopaminergic neurons play an important role in retention of both short-term memory, tested in the Ymaze task and long-term memory evaluated with the multi-trial passive avoidance test, without affecting memory acquisition. As compared to short-term memory, long-term memory is more susceptible to the decreased dopamine level in nervous structures involved in processing and storage of information
The occurrence, exposure and risk assessment of perfluoroalkyl acids in food from mainland, China.
Wang, Xinxuan; Zhang, Ruobing; Zhang, Hong; Wang, Yanping
2017-11-01
To study the contamination of perfluoroalkyl acids (PFAAs) in Chinese food and the risk of dietary exposure for the Chinese population, the data of 17 PFAAs covering 38 cities throughout China in 15 groups of foods were collected for meta-analysis from published and available research literature. Using food consumption and body weight parameters, estimated dietary intakes (EDIs) were calculated for evaluation using the Scenario-Based Risk Assessment (SceBRA) modelling. Among food groups, the highest ΣPFAAs concentrations and EDI contributions were both found in poultry (363 ng/g), fish and shrimp (313 ng/g), dark vegetables (309 ng/g), fruits (116 ng/g) and pork (25 ng/g). The EDI of adults in the high-exposure scenario was about twice that of the intermediate-exposure scenario, while the EDI of children was about twice that of adults' EDI in the intermediate-exposure scenario. In addition, the PFOS EDI for children under high exposure approached its tolerable daily intake (TDI). Therefore high dietary exposure to PFAAs is giving rise to an increased health risk, especially for children.
Directory of Open Access Journals (Sweden)
Stamuli Eugena
2012-02-01
Full Text Available Abstract Background Plantar warts (verrucae are extremely common. Although many will spontaneously disappear without treatment, treatment may be sought for a variety of reasons such as discomfort. There are a number of different treatments for cutaneous warts, with salicylic acid and cryotherapy using liquid nitrogen being two of the most common forms of treatment. To date, no full economic evaluation of either salicylic acid or cryotherapy has been conducted based on the use of primary data in a pragmatic setting. This paper describes the cost-effectiveness analysis which was conducted alongside a pragmatic multicentre, randomised trial evaluating the clinical effectiveness of cryotherapy versus 50% salicylic acid of the treatment of plantar warts. Methods A cost-effectiveness analysis was undertaken alongside a pragmatic multicentre, randomised controlled trial assessing the clinical effectiveness of 50% salicylic acid and cryotherapy using liquid nitrogen at 12 weeks after randomisation of patients. Cost-effectiveness outcomes were expressed as the additional cost required to completely cure the plantar warts of one additional patient. A NHS perspective was taken for the analysis. Results Cryotherapy costs on average £101.17 (bias corrected and accelerated (BCA 95% CI: 85.09-117.26 more per participant over the 12 week time-frame, while there is no additional benefit, in terms of proportion of patients healed compared with salicylic acid. Conclusions Cryotherapy is more costly and no more effective than salicylic acid. Trial registration Current Controlled Trials ISRCTN18994246 [controlled-trials.com] and National Research Register N0484189151.
2012-01-01
Abstract Background Plantar warts (verrucae) are extremely common. Although many will spontaneously disappear without treatment, treatment may be sought for a variety of reasons such as discomfort. There are a number of different treatments for cutaneous warts, with salicylic acid and cryotherapy using liquid nitrogen being two of the most common forms of treatment. To date, no full economic evaluation of either salicylic acid or cryotherapy has been conducted based on the use of primary data in a pragmatic setting. This paper describes the cost-effectiveness analysis which was conducted alongside a pragmatic multicentre, randomised trial evaluating the clinical effectiveness of cryotherapy versus 50% salicylic acid of the treatment of plantar warts. Methods A cost-effectiveness analysis was undertaken alongside a pragmatic multicentre, randomised controlled trial assessing the clinical effectiveness of 50% salicylic acid and cryotherapy using liquid nitrogen at 12 weeks after randomisation of patients. Cost-effectiveness outcomes were expressed as the additional cost required to completely cure the plantar warts of one additional patient. A NHS perspective was taken for the analysis. Results Cryotherapy costs on average £101.17 (bias corrected and accelerated (BCA) 95% CI: 85.09-117.26) more per participant over the 12 week time-frame, while there is no additional benefit, in terms of proportion of patients healed compared with salicylic acid. Conclusions Cryotherapy is more costly and no more effective than salicylic acid. Trial registration Current Controlled Trials ISRCTN18994246 [controlled-trials.com] and National Research Register N0484189151. PMID:22369511
Kortüm, K; Reznicek, L; Leicht, S; Ulbig, M; Wolf, A
2013-07-01
The importance and complexity of clinical trials is continuously increasing, especially in innovative specialties like ophthalmology. Therefore an efficient clinical trial site organisational structure is essential. In modern internet times, this can be accomplished by web-based applications. In total, 3 software applications (Vibe on Prem, Sharepoint and open source software) were evaluated in a clinical trial site in ophthalmology. Assessment criteria were set; they were: reliability, easiness of administration, usability, scheduling, task list, knowledge management, operating costs and worldwide availability. Vibe on Prem customised by the local university met the assessment criteria best. Other applications were not as strong. By introducing a web-based application for administrating and organising an ophthalmological trial site, studies can be conducted in a more efficient and reliable manner. Georg Thieme Verlag KG Stuttgart · New York.
Rivoirard, Romain; Langrand-Escure, Julien; Oriol, Mathieu; Tinquaut, Fabien; Chauvin, Franck; Rancoule, Chloé; Magné, Nicolas; Bourmaud, Aurélie
2018-05-01
To describe the current state of knowledge concerning the quality of reporting in phase II clinical trials in oncology and to describe the various methods published allowing this quality evaluation. databases including MEDLINE and COCHRANE were searched. Reviews and meta-analyses analyzing the quality of the reporting of phase II trials in oncology were included. Descriptive analysis of the results was performed. Thirteen publications were retained. Only 2 publications adopted a systematic approach of evaluation of the quality of reporting by overall scores. The Key Methodological Score (KMS), proposed by Grellety et al., gathering 3 items, seemed adapted for such an evaluation. A score of 3/3 was found in 16.1% of the 156 phase II trials analysed by this score. The other reviews used a qualitative analysis to evaluate the reporting, via an analysis of a single criterion, generally the statistical plan of the study. This item was considered as having been correctly reported in less than 50% of the analysed articles. The quality of reporting in phase II trials in oncology is a field that has been investigated very little (13 publications). When it is studied, the estimated level of quality is not satisfactory, whatever the method employed. The use of an overall score of evaluation is a path which should be pursued, in order to get reliable results. It also seems necessary to propose strong recommendations, which would create a consensus for the methodology and the reporting of these studies. Copyright © 2018 Elsevier B.V. All rights reserved.
Evaluation of climate policy in the Netherlands 2005. On the way to Kyoto
International Nuclear Information System (INIS)
Bonney, M.
2005-01-01
An evaluation of climate policy in the Netherlands aimed at the realization of targets as formulated in the Kyoto Protocol. The Dutch target is to reduce the emission of greenhouse gases by 6% for the period 2008-2012, compared to the emission in 1990 [nl
Minois, Nathan; Lauwers-Cances, Valérie; Savy, Stéphanie; Attal, Michel; Andrieu, Sandrine; Anisimov, Vladimir; Savy, Nicolas
2017-10-15
At the design of clinical trial operation, a question of a paramount interest is how long it takes to recruit a given number of patients. Modelling the recruitment dynamics is the necessary step to answer this question. Poisson-gamma model provides very convenient, flexible and realistic approach. This model allows predicting the trial duration using data collected at an interim time with very good accuracy. A natural question arises: how to evaluate the parameters of recruitment model before the trial begins? The question is harder to handle as there are no recruitment data available for this trial. However, if there exist similar completed trials, it is appealing to use data from these trials to investigate feasibility of the recruitment process. In this paper, the authors explore the recruitment data of two similar clinical trials (Intergroupe Francais du Myélome 2005 and 2009). It is shown that the natural idea of plugging the historical rates estimated from the completed trial in the same centres of the new trial for predicting recruitment is not a relevant strategy. In contrast, using the parameters of a gamma distribution of the rates estimated from the completed trial in the recruitment dynamic model of the new trial provides reasonable predictive properties with relevant confidence intervals. Copyright © 2017 John Wiley & Sons, Ltd. Copyright © 2017 John Wiley & Sons, Ltd.
A random walk model for evaluating clinical trials involving serial observations.
Hopper, J L; Young, G P
1988-05-01
For clinical trials where the variable of interest is ordered and categorical (for example, disease severity, symptom scale), and where measurements are taken at intervals, it might be possible to achieve a greater discrimination between the efficacy of treatments by modelling each patient's progress as a stochastic process. The random walk is a simple, easily interpreted model that can be fitted by maximum likelihood using a maximization routine with inference based on standard likelihood theory. In general the model can allow for randomly censored data, incorporates measured prognostic factors, and inference is conditional on the (possibly non-random) allocation of patients. Tests of fit and of model assumptions are proposed, and application to two therapeutic trials of gastroenterological disorders are presented. The model gave measures of the rate of, and variability in, improvement for patients under different treatments. A small simulation study suggested that the model is more powerful than considering the difference between initial and final scores, even when applied to data generated by a mechanism other than the random walk model assumed in the analysis. It thus provides a useful additional statistical method for evaluating clinical trials.
Evaluation of Wet Cupping Therapy: Systematic Review of Randomized Clinical Trials.
Al Bedah, Abdullah M N; Khalil, Mohamed K M; Posadzki, Paul; Sohaibani, Imen; Aboushanab, Tamer Shaaban; AlQaed, Meshari; Ali, Gazzaffi I M
2016-10-01
Wet cupping is a widely used traditional therapy in many countries, which justifies a continuous scientific evaluation of its efficacy and safety. To perform a systematic review to critically evaluate and update the available evidence of wet cupping in traditional and complementary medicine. Ten electronic databases were searched from their inceptions to February 2016. Included studies were randomized clinical trials (RCTs) that evaluated wet cupping against any type of control interventions in patients with any clinical condition, as well as healthy individuals. Cochrane risk of bias tool was used to appraise the included RCTs. Fourteen RCTs met the eligibility criteria. The included studies evaluated the following clinical conditions: nonspecific low back pain (NSLBP), hypertension, brachialgia, carpal tunnel syndrome (CTS), chronic neck pain, metabolic syndrome, migraine headaches, oxygen saturation in smokers with chronic obstructive pulmonary disease (COPD), and oral and genital ulcers due to Behçet disease. Two RCTs evaluated physiologic and biochemical parameters of healthy individuals. Overall, 9 RCTs favored wet cupping over various control interventions in NSLBP (n = 2), hypertension (n = 1), brachialgia (n = 1), CTS (n = 1), chronic neck pain (n = 2), oxygen saturation in smokers with COPD (n = 1), and oral and genital ulcers due to Behçet disease (n = 1). Five RCTs showed no statistically significant between-group differences: NSLBP (n = 1), metabolic syndrome (n = 1), migraine headaches (n = 1), and physiologic and biochemical parameters of healthy individuals (n = 2). Included RCTs had a variable risk of bias across all domains and suffered methodologic limitations. There is a promising evidence in favor of the use of wet cupping for musculoskeletal pain, specifically NSLBP, neck pain, CTS, and brachialgia. Better-quality trials are needed to generate solid evidence and firmly inform policy makers.
Small-scale geodiversity and dirt road management, Ede (NL)
van den Ancker, Hanneke; Jungerius, Pieter Dirk
2016-04-01
A large part of the countryside roads on the Pleistocene sands of The Netherlands are dirt roads. Most are footpaths, but a small percentage are relatively heavily used by motorized vehicles. These latter roads are a cause subject of debate. Puddles and potholes develop during periods of wet weather, while dust whirls from the roads form during spells of dry weather as do washboard ripples. They cause problems for people living along these roads and tourists (walkers and bikers. The community of Ede (NL), like many other communities on the sand, wants to keep its 80 km of dirt roads because of the natural values they harbour as well as for their characteristic landscape quality and cultural heritage value. A part of the dirt roads in Ede is heavily used. In 2009, the community of Ede developed a decision model to support management of the dirt roads. Ede acknowledges that each dirt road is unique and asks for a tailor-made solution. Road maintenance measures include grading, making a camber, digging pits, applying loam or sandy loam. If problems become too large, one-way traffic can be an option. In more and more cases the dirt roads are barred for motorized through traffic (Gemeente Ede, 2009). As a reconnaissance we have studied the dirt roads of the Horabos/Horalaan over the last year. Incidentally we looked at other parts of the main Horalaan and the footpaths in the adjacent forest of Hoekelum. All dirt roads lie near the top of a Saalian push-moraine in which the upper course of dry valleys are present. Some results of the reconnaissance: - Most dirt roads sections in the Horabos lie lower than the surrounding terrain; - The problems develop in a short period of time during special weather conditions; - Certain dirt road sections e.g. those sections crossing a slight depression are quickly developing potholes; - Even a small slope of the road (differences that have consequences for its maintenance. Knowledge of geodiversity of the terrain and study of small
Directory of Open Access Journals (Sweden)
Norma Sandra de Almeida Ferreira
2009-08-01
Full Text Available Localizar em sua materialidade a obra Ou isto ou aquilo, de Cecília Meireles, em suas edições - 1964; 1969; 1977; 1987; 1990; 2002 -; cotejá-las para compreender as formas pelas quais os textos são apresentados aos seus leitores, em diferentes tempos; e indagar como e por que essas formas são pensadas e concretizadas são desafios deste artigo. Esta pesquisa de cunho exploratório, à luz, principalmente, dos estudos da História Cultural, privilegia, no exame das diferentes edições, as partes externas que envolvem os poemas (o texto propriamente dito e suas ilustrações. Identifica e discute a produção de sentidos e valores ligados à educação do leitor, ao reconhecimento de uma escritora consagrada pela tradição literária, à singularidade da linguagem, à importância de uma prática prazerosa da leitura.This article brings the challenges of locating Cecília Meireles' book Ou isto ou aquilo (Either this or that in its materialness, with considerations on its 1964, 1969, 1977, 1987, 1990 and 2002 editions, as well as comparing these editions in order to understand the forms in which texts are presented to their readers at different times, and questioning how and why these forms are conceived and put into practice. In the light of studies on cultural history, in the analysis of the different editions, this exploratory research prioritizes the external parts that involve poems (the texts themselves and their illustrations. It provides identification and a discussion on the production of senses and values related to readers' education, the recognition of a writer who is consecrated by literary tradition, the uniqueness of the language used, and the importance of pleasant reading practice.
Process evaluation of a web-based intervention aimed at empowerment of disability benefit claimants
Samoocha, D.; Snels, I.A.K.; Bruinvels, D.J.; Anema, J.R.; Kowalczyk, W.J.; van der Beek, A.J.
2011-01-01
Background: The objective of this process evaluation study was to gain insight into the reach, compliance, appreciation, usage barriers, and users' perceived effectiveness of a web-based intervention http://www.wiagesprek.nl. This intervention was aimed at empowerment of disability claimants, prior
Process evaluation of a web-based intervention aimed at empowerment of disability benefit claimants
Samoocha, David; Snels, Ingrid A. K.; Bruinvels, David J.; Anema, Johannes R.; Kowalczyk, Wojtek; van der Beek, Allard J.
2011-01-01
The objective of this process evaluation study was to gain insight into the reach, compliance, appreciation, usage barriers, and users' perceived effectiveness of a web-based intervention http://www.wiagesprek.nl. This intervention was aimed at empowerment of disability claimants, prior to the
Perry, Helen; Duffy, James M N; Umadia, Ogochukwu; Khalil, Asma
2018-04-01
Twin-Twin Transfusion syndrome is associated with significant mortality and morbidity. Potential treatments require robust evaluation. The aim of this study was to evaluate outcome reporting across observational studies and randomised controlled trials assessing treatments for twin-twin transfusion syndrome (TTTS). Cochrane Central Register of Controlled Trials, EMBASE and Medline were searched from inception to August 2016. Observational studies and randomised controlled trials reporting outcomes following a treatment for TTTS in monochorionic-diamniotic twin pregnancies and monochorionic-triamniotic or dichorionic-triamniotic triplet pregnancies were included. We systematically extracted and categorised outcome reporting. Six randomised trials and 94 observational studies, reporting data from 20,071 maternal participants and 3,199 children, were included. Six different treatments were evaluated. Included studies reported sixty-two different outcomes, including 10 fetal, 28 neonatal, 6 early childhood and 18 maternal outcomes. The outcomes were inconsistently reported across trials. For example, when considering offspring mortality, 31 studies (31%) reported live birth, 31 studies (31%) reported intrauterine death, 49 studies (49%) reported neonatal mortality, and 17 studies (17%) reported perinatal mortality. Four studies (4%) reported respiratory distress syndrome. Only 19 (19%) of studies were designed for long-term follow-up and 11 of these studies (11%) reported cerebral palsy. Most studies evaluating treatments for TTTS, have often neglected to report clinically important outcomes, especially neonatal morbidity outcomes. Most studies are not designed for long-term follow-up. The development of a core outcome set could help standardised outcome collection and reporting in Twin-Twin Transfusion syndrome studies. This article is protected by copyright. All rights reserved.
Lederhuber, Hans; Stiede, Franziska; Axer, Stephan; Dahlstrand, Ursula
2017-11-01
The issue of mesh fixation in endoscopic inguinal hernia repair is frequently debated and still no conclusive data exist on differences between methods regarding long-term outcome and postoperative complications. The quantity of trials and the simultaneous lack of high-quality evidence raise the question how future trials should be planned. PubMed, EMBASE and the Cochrane Library were searched, using the filters "randomised clinical trials" and "humans". Trials that compared one method of mesh fixation with another fixation method or with non-fixation in endoscopic inguinal hernia repair were eligible. To be included, the trial was required to have assessed at least one of the following primary outcome parameters: recurrence; surgical site infection; chronic pain; or quality-of-life. Fourteen trials assessing 2161 patients and 2562 hernia repairs were included. Only two trials were rated as low risk for bias. Eight trials evaluated recurrence or surgical site infection; none of these could show significant differences between methods of fixation. Two of 11 trials assessing chronic pain described significant differences between methods of fixation. One of two trials evaluating quality-of-life showed significant differences between fixation methods in certain functions. High-quality evidence for differences between the assessed mesh fixation techniques is still lacking. From a socioeconomic and ethical point of view, it is necessary that future trials will be properly designed. As small- and medium-sized single-centre trials have proven unable to find answers, register studies or multi-centre studies with an evident focus on methodology and study design are needed in order to answer questions about mesh fixation in inguinal hernia repair.
Kidholm, Kristian; Kristensen, Mie Borch Dahl
2018-04-01
Many countries have considered telemedicine and home monitoring of patients as a solution to the demographic challenges that health-care systems face. However, reviews of economic evaluations of telemedicine have identified methodological problems in many studies as they do not comply with guidelines. The aim of this study was to examine economic evaluations alongside randomised controlled trials of home monitoring in chronic disease management and hereby to explore the resources included in the programme costs, the types of health-care utilisation that change as a result of home monitoring and discuss the value of economic evaluation alongside randomised controlled trials of home monitoring on the basis of the studies identified. A scoping review of economic evaluations of home monitoring of patients with chronic disease based on randomised controlled trials and including information on the programme costs and the costs of equipment was carried out based on a Medline (PubMed) search. Nine studies met the inclusion criteria. All studies include both costs of equipment and use of staff, but there is large variation in the types of equipment and types of tasks for the staff included in the costs. Equipment costs constituted 16-73% of the total programme costs. In six of the nine studies, home monitoring resulted in a reduction in primary care or emergency contacts. However, in total, home monitoring resulted in increased average costs per patient in six studies and reduced costs in three of the nine studies. The review is limited by the small number of studies found and the restriction to randomised controlled trials, which can be problematic in this area due to lack of blinding of patients and healthcare professionals and the difficulty of implementing organisational changes in hospital departments for the limited period of a trial. Furthermore, our results may be based on assessments of older telemedicine interventions.
Competency to stand trial evaluations: a study of actual practice in two states.
Robbins, E; Waters, J; Herbert, P
1997-01-01
A criminal defendant must be competent to stand trial (CST) to safeguard the fundamental right to a fair trial. If there is a question as to a defendant's ability to assist in his or her own defense, a mental health professional is asked to perform a CST evaluation. Forensic assessment is a growing field, and CST is the most frequent evaluation requested. Over the years, forensic examiners' reports to the courts have been criticized for lack of relevance, insufficiency, and invading the province of the judge. If mental health professionals wish to advance the field of forensic assessment and respond to these criticisms, research on current practice with suggestions for advancement are necessary. A total of 66 CST reports conducted within the last five years in two states were compared to a proposed model for CST assessment. Results indicated that although forensic examiners are maintaining legal relevance, some CST reports may lack thoroughness and/or provide information that exceeds their role responsibilities. The findings support the need for the development of a standardized method of conducting and writing CST evaluations that should improve the quality of such reports.
2014-01-01
Background Babies born after midtrimester preterm prelabour rupture of membranes (PPROM) are at risk to develop neonatal pulmonary hypoplasia. Perinatal mortality and morbidity after this complication is high. Oligohydramnios in the midtrimester following PPROM is considered to cause a delay in lung development. Repeated transabdominal amnioinfusion with the objective to alleviate oligohydramnios might prevent this complication and might improve neonatal outcome. Methods/Design Women with PPROM and persisting oligohydramnios between 16 and 24 weeks gestational age will be asked to participate in a multi-centre randomised controlled trial. Intervention: random allocation to (repeated) abdominal amnioinfusion (intervention) or expectant management (control). The primary outcome is perinatal mortality. Secondary outcomes are lethal pulmonary hypoplasia, non-lethal pulmonary hypoplasia, survival till discharge from NICU, neonatal mortality, chronic lung disease (CLD), number of days ventilatory support, necrotizing enterocolitis (NEC), periventricular leucomalacia (PVL) more than grade I, severe intraventricular hemorrhage (IVH) more than grade II, proven neonatal sepsis, gestational age at delivery, time to delivery, indication for delivery, successful amnioinfusion, placental abruption, cord prolapse, chorioamnionitis, fetal trauma due to puncture. The study will be evaluated according to intention to treat. To show a decrease in perinatal mortality from 70% to 35%, we need to randomise two groups of 28 women (two sided test, β-error 0.2 and α-error 0.05). Discussion This study will answer the question if (repeated) abdominal amnioinfusion after midtrimester PPROM with associated oligohydramnios improves perinatal survival and prevents pulmonary hypoplasia and other neonatal morbidities. Moreover, it will assess the risks associated with this procedure. Trial registration NTR3492 Dutch Trial Register (http://www.trialregister.nl). PMID:24708702
Hektoen, L; Ødegaard, S A; Løken, T; Larsen, S
2004-05-01
There is often a need to reduce sample size in clinical trials due to practical limitations and ethical considerations. Better comparability between treatment groups by use of stratification in the design, and use of continuous outcome variables in the evaluation of treatment results, are two methods that can be used in order to achieve this. In this paper the choice of stratification factors in trials of clinical mastitis in dairy cows is investigated, and two score-scales for evaluation of clinical mastitis are introduced. The outcome in 57 dairy cows suffering from clinical mastitis and included in a clinical trial comparing homeopathic treatment, placebo and a standard antibiotic treatment is investigated. The strata of various stratification factors are compared across treatments to determine which other factors influence outcome. The two score scales, measuring acute and chronic mastitis symptoms, respectively, are evaluated on their ability to differentiate between patients classified from clinical criteria as responders or non-responders to treatment. Differences were found between the strata of the factors severity of mastitis, lactation number, previous mastitis this lactation and bacteriological findings. These factors influence outcome of treatment and appear relevant as stratification factors in mastitis trials. Both score scales differentiated between responders and non-responders to treatment and were found useful for evaluation of mastitis and mastitis treatment.
Directory of Open Access Journals (Sweden)
M. Rainer Lepsius
2012-01-01
Full Text Available O artigo relata o entendimento atual do conjunto de textos conhecido como Economia e sociedade, procurando esclarecer em que consistia originalmente; como foi organizado nas edições anteriores por Marianne Weber e Johannes Winckelmann; como foi tratado no âmbito da nova edição da MWG. Para tanto, procura indicar como Max Weber situava os diversos textos, as diversas versões e fases de concepção e composição desses escritos. A partir daí, sistematiza os principais aspectos dos textos evidenciados na MWG, assim como os principais campos de discussão que se abrem para a pesquisa, em especial a sociologia econômica.The article reviews the current understanding of the set of texts known as Economy and Society, looking to identify the original content, how these texts were edited in previous editions by Marianne Weber and Johannes Winckelmann, and how they have been dealt with in the new edition of the MWG. These aims in mind, the text looks to show how Max Weber himself situated the various texts, including the different versions and phases of conception and composition of the writings. The article then summarizes the main aspects of the works, as evinced in the MWG, as well as the principal fields of discussion opened up for research, especially in economic sociology.
Evaluation of eligibility and recruitment in breast cancer clinical trials.
Lemieux, Julie; Forget, Geneviève; Brochu, Olyvia; Provencher, Louise; Cantin, Guy; Desbiens, Christine; Doyle, Catherine; Poirier, Brigitte; Camden, Stéphanie; Durocher, Martin
2014-08-01
Objectives of the study were to measure recruitment rates in clinical trials and to identify patients, physicians or trials characteristics associated with higher recruitment rates. Among patients who had a clinical trial available for their cancer, 83.5% (345/413) met the eligibility criteria to at least one clinical trial. At least one trial was proposed to 33.1% (113/341) of the eligible patients and 19.7% (68/345) were recruited. Overall recruitment was 16.5% (68/413). In multivariate analyses, trial proposal and enrollment were lower for elderly patients and higher in high cancer stages. Trials from pharmaceutical industry had higher recruitment rates and trials testing hormonal therapy enrolled more patients. Breast cancer patients' accrual to a clinical trial could be improved by trying to systematically identify all eligible patients and propose a trial to those eligible and to whom the treatment is planned to be equivalent to the standard arm of the trial. Copyright © 2014 Elsevier Ltd. All rights reserved.
Dunn, Graham; Emsley, Richard; Liu, Hanhua; Landau, Sabine; Green, Jonathan; White, Ian; Pickles, Andrew
2015-11-01
The development of the capability and capacity to evaluate the outcomes of trials of complex interventions is a key priority of the National Institute for Health Research (NIHR) and the Medical Research Council (MRC). The evaluation of complex treatment programmes for mental illness (e.g. cognitive-behavioural therapy for depression or psychosis) not only is a vital component of this research in its own right but also provides a well-established model for the evaluation of complex interventions in other clinical areas. In the context of efficacy and mechanism evaluation (EME) there is a particular need for robust methods for making valid causal inference in explanatory analyses of the mechanisms of treatment-induced change in clinical outcomes in randomised clinical trials. The key objective was to produce statistical methods to enable trial investigators to make valid causal inferences about the mechanisms of treatment-induced change in these clinical outcomes. The primary objective of this report is to disseminate this methodology, aiming specifically at trial practitioners. The three components of the research were (1) the extension of instrumental variable (IV) methods to latent growth curve models and growth mixture models for repeated-measures data; (2) the development of designs and regression methods for parallel trials; and (3) the evaluation of the sensitivity/robustness of findings to the assumptions necessary for model identifiability. We illustrate our methods with applications from psychological and psychosocial intervention trials, keeping the technical details to a minimum, leaving the reporting of the more theoretical and mathematically demanding results for publication in appropriate specialist journals. We show how to estimate treatment effects and introduce methods for EME. We explain the use of IV methods and principal stratification to evaluate the role of putative treatment effect mediators and therapeutic process measures. These results are
Association between lifestyle factors and quality-adjusted life years in the EPIC-NL cohort.
Fransen, Heidi P; May, Anne M; Beulens, Joline W J; Struijk, Ellen A; de Wit, G Ardine; Boer, Jolanda M A; Onland-Moret, N Charlotte; Hoekstra, Jeljer; van der Schouw, Yvonne T; Bueno-de-Mesquita, H Bas; Peeters, Petra H M
2014-01-01
The aim of our study was to relate four modifiable lifestyle factors (smoking status, body mass index, physical activity and diet) to health expectancy, using quality-adjusted life years (QALYs) in a prospective cohort study. Data of the prospective EPIC-NL study were used, including 33,066 healthy men and women aged 20-70 years at baseline (1993-7), followed until 31-12-2007 for occurrence of disease and death. Smoking status, body mass index, physical activity and adherence to a Mediterranean-style diet (excluding alcohol) were investigated separately and combined into a healthy lifestyle score, ranging from 0 to 4. QALYs were used as summary measure of healthy life expectancy, combining a person's life expectancy with a weight for quality of life when having a chronic disease. For lifestyle factors analyzed separately the number of years living longer in good health varied from 0.12 year to 0.84 year, after adjusting for covariates. A combination of the four lifestyle factors was positively associated with higher QALYs (P-trend healthy lifestyle score of 4 compared to a score of 0 was associated with almost a 2 years longer life in good health (1.75 QALYs [95% CI 1.37, 2.14]).
Evaluation of the trial design studies for an advanced marine reactor, (2)
International Nuclear Information System (INIS)
Ambo, Noriaki; Yokomura, Takeyoshi.
1988-03-01
As for the CARAMEL fuel (plate-type fuel) that was the fuel of the integrated-type reactor which was one of the trial design studies for an Advanced Marine Reactor, its structure and its fuel specific characteristics were studied and compared with a fuel rod (cylindrical fuel), and the total characteristics of the caramel fuel was reviewed and evaluated. (author)
Campos, Nicole G.; Castle, Philip E.; Schiffman, Mark; Kim, Jane J.
2013-01-01
Background Although the randomized controlled trial (RCT) is widely considered the most reliable method for evaluation of health care interventions, challenges to both internal and external validity exist. Thus, the efficacy of an intervention in a trial setting does not necessarily represent the real-world performance that decision makers seek to inform comparative effectiveness studies and economic evaluations. Methods Using data from the ASCUS-LSIL Triage Study (ALTS), we performed a simplified economic evaluation of age-based management strategies to detect cervical intraepithelial neoplasia grade 3 (CIN3) among women who were referred to the study with low-grade squamous intraepithelial lesions (LSIL). We used data from the trial itself to adjust for 1) potential lead time bias and random error that led to variation in the observed prevalence of CIN3 by study arm, and 2) potential ascertainment bias among providers in the most aggressive management arm. Results We found that using unadjusted RCT data may result in counterintuitive cost-effectiveness results when random error and/or bias are present. Following adjustment, the rank order of management strategies changed for two of the three age groups we considered. Conclusion Decision analysts need to examine study design, available trial data and cost-effectiveness results closely in order to detect evidence of potential bias. Adjustment for random error and bias in RCTs may yield different policy conclusions relative to unadjusted trial data. PMID:22147881
Juch, Johan N S; Maas, Esther T; Ostelo, Raymond W J G; Groeneweg, J George; Kallewaard, Jan-Willem; Koes, Bart W; Verhagen, Arianne P; van Dongen, Johanna M; Huygen, Frank J P M; van Tulder, Maurits W
2017-07-04
Radiofrequency denervation is a commonly used treatment for chronic low back pain, but high-quality evidence for its effectiveness is lacking. To evaluate the effectiveness of radiofrequency denervation added to a standardized exercise program for patients with chronic low back pain. Three pragmatic multicenter, nonblinded randomized clinical trials on the effectiveness of minimal interventional treatments for participants with chronic low back pain (Mint study) were conducted in 16 multidisciplinary pain clinics in the Netherlands. Eligible participants were included between January 1, 2013, and October 24, 2014, and had chronic low back pain, a positive diagnostic block at the facet joints (facet joint trial, 251 participants), sacroiliac joints (sacroiliac joint trial, 228 participants), or a combination of facet joints, sacroiliac joints, or intervertebral disks (combination trial, 202 participants) and were unresponsive to conservative care. All participants received a 3-month standardized exercise program and psychological support if needed. Participants in the intervention group received radiofrequency denervation as well. This is usually a 1-time procedure, but the maximum number of treatments in the trial was 3. The primary outcome was pain intensity (numeric rating scale, 0-10; whereby 0 indicated no pain and 10 indicated worst pain imaginable) measured 3 months after the intervention. The prespecified minimal clinically important difference was defined as 2 points or more. Final follow-up was at 12 months, ending October 2015. Among 681 participants who were randomized (mean age, 52.2 years; 421 women [61.8%], mean baseline pain intensity, 7.1), 599 (88%) completed the 3-month follow-up, and 521 (77%) completed the 12-month follow-up. The mean difference in pain intensity between the radiofrequency denervation and control groups at 3 months was -0.18 (95% CI, -0.76 to 0.40) in the facet joint trial; -0.71 (95% CI, -1.35 to -0.06) in the sacroiliac joint
Directory of Open Access Journals (Sweden)
V. B. Ivanov
2017-01-01
Full Text Available The article considers the experience of Russian and leading foreign regulatory agencies in organisation and conduction of preclinical and clinical trials of human immunoglobulin products. The authors suggest a classification of human immunoglobulins and provide updated information on authorization of these products in Russia. The article summarizes methodological approaches, basic scientific principles and criteria relating to expert evaluation of preclinical and clinical trials of blood products. The authors further define the expert body’s requirements for data on preclinical and clinical trials of human normal immuniglobulins and human specific immunoglobulins for the prevention and/or treatment of infectious and non-infectious diseases which are submitted as part of applications for marketing authorization or marketing authorization variation. The article suggests programs of preclinical and clinical trials for human normal immunoglobulins and human specific immunoglobulins for the prevention and/or treatment of infectious and non-infectious diseases that are aligned with the Russian legislation and Eurasian Economic Union’s regulations on medicines circulation, and have been elaborated with respect to the guidelines of the European Medicines Agency.
Roberts, Shelley; McInnes, Elizabeth; Bucknall, Tracey; Wallis, Marianne; Banks, Merrilyn; Chaboyer, Wendy
2017-02-13
As pressure ulcers contribute to significant patient burden and increased health care costs, their prevention is a clinical priority. Our team developed and tested a complex intervention, a pressure ulcer prevention care bundle promoting patient participation in care, in a cluster-randomised trial. The UK Medical Research Council recommends process evaluation of complex interventions to provide insight into why they work or fail and how they might be improved. This study aimed to evaluate processes underpinning implementation of the intervention and explore end-users' perceptions of it, in order to give a deeper understanding of its effects. A pre-specified, mixed-methods process evaluation was conducted as an adjunct to the main trial, guided by a framework for process evaluation of cluster-randomised trials. Data was collected across eight Australian hospitals but mainly focused on the four intervention hospitals. Quantitative and qualitative data were collected across the evaluation domains: recruitment, reach, intervention delivery and response to intervention, at both cluster and individual patient level. Quantitative data were analysed using descriptive and inferential statistics. Qualitative data were analysed using thematic analysis. In the context of the main trial, which found a 42% reduction in risk of pressure ulcer with the intervention that was not significant after adjusting for clustering and covariates, this process evaluation provides important insights. Recruitment and reach among clusters and individuals was high, indicating that patients, nurses and hospitals are willing to engage with a pressure ulcer prevention care bundle. Of 799 intervention patients in the trial, 96.7% received the intervention, which took under 10 min to deliver. Patients and nurses accepted the care bundle, recognising benefits to it and describing how it enabled participation in pressure ulcer prevention (PUP) care. This process evaluation found no major failures
Directory of Open Access Journals (Sweden)
Andrea Lago da Silva
1999-12-01
Full Text Available As tecnologias de informação têm alterado as formas de coordenação entre os diferentes elos da cadeia de suprimentos. A coordenação pode ser entendida como a habilidade de transmitir informação, estímulos e controles ao longo das etapas seqüenciais que integram o conjunto de atividades necessárias para atender o mercado (FARINA & ZYLBERSZTAJN, 1994. O conjunto destas etapas é o que tem sido chamado de Supply Chain ou Cadeia de Suprimentos. Neste artigo, discute-se alguns casos de adoção de uma tecnologia de informação, o EDI (troca eletrônica de dados como ferramenta de coordenação entre varejistas e indústrias agroalimentares. Conclui-se que o processo de adoção é relativamente recente para que se possa mensurar resultados quantitativos e qualitativos significativos, mas já se observa alterações na freqüência de desabastecimento, em estoques melhor dimensionados e vendas maiores em decorrência da maior disponibilidade de mercadorias. Sinalizam-se também mudanças qualitativas, como alteração na função do vendedor tradicional, maior interação entre as áreas técnicas, com um aprendizado comum das novas formas de usar a tecnologia e o importante papel da confiança nos relacionamentos interorganizações.Information technology has changed the patterns of coordination among the different linkages of supply-chains. Coordination can be understood as the ability to transfer information, incentives and controls throughout the sequential stages which integrate the set of activities indispensable to serve the market (FARINA & ZYLBERSZTAJN, 1994. The sum of these stages is currently known as Supply-Chains. This paper discusses cases of adopting a specific information technology, EDI (Electronic Data Interchange, as an integration tool between the food industry and retailers. It was found that the adoption process is too recent to measure significative quantitative results, but it is possible to observe changes in the
Beam-foil lifetime measurements for some 5d10 nl and 5d96s6p levels of Pb IV
International Nuclear Information System (INIS)
Pinnington, E.H.; Ansbacher, W.; Tauheed, A.; Kernahan, J.A.
1991-01-01
The beam-foil technique was used to measure the lifetimes of the 5d 10 5f, 5g, 6d, 6h, 7p, 7d, 8s and 5d 9 6s6p (2) 0 , (3) 0 , (6) 0 , (14) 0 , (17) 0 levels of Pb IV. Correlated decay-curve analyses were used to correct for the effects of cascading in the case of the 5d 10 5f, 5g, 6d, and 7p levels. The numerical Coulomb approximation was used to calculate comparison values for the 5d 10 nl levels. The need for a more rigorous calculation for specific levels is discussed. (12 refs., fig., tab.)
Hussain, Maha; Tangen, Catherine; Higano, Celestia; Vogelzang, Nicholas; Thompson, Ian
2016-01-20
Intermittent androgen deprivation (IAD) has been widely tested in prostate cancer. However, phase III trials testing continuous androgen deprivation (CAD) versus IAD have reached inconclusive and seemingly contradictory results. Different design and conduct issues must be critically evaluated to better interpret the results. Seven published phase III trials were examined for prespecified design and outcomes. Treatment specifications; primary end point; superiority versus noninferiority design assumptions, including magnitude of assumed versus observed noninferiority margin (NIM); duration of follow-up; and quality-of-life (QOL) outcomes were considered in terms of the results and conclusions reported. Five trials had a superiority and three had a noninferiority primary hypothesis. Only three trials had a uniform population and overall survival (OS) end point. All trials observed better outcomes in terms of OS and progression-free survival (PFS) than assumed at time of study design, translating into prespecified NIMs or hazard ratios that reflected larger absolute differences in OS or PFS between arms. Lower-than-expected event rates also reduced statistical power for the trials. Other factors, including length of follow-up, cause of death, QOL, and primary end point, and their impact on trial interpretation are discussed. No trial to date has demonstrated survival superiority of IAD compared with CAD. Trials concluding IAD is noninferior to CAD were based on wide NIMs that included clinically important survival differences, not likely to be considered comparable by physicians or patients. Interim analyses relying on short follow-up and including a majority of non-prostate cancer deaths will favor a noninferiority conclusion and should be interpreted cautiously. Adequate follow-up is required to ensure capture of prostate cancer deaths in both superiority and noninferiority trials. © 2015 by American Society of Clinical Oncology.
Geraets, J.J.; Goossens, M.E.J.B.; Haastregt, J.C. van; Groot, I.J.M. de; Bruijn, C.P. de; Bie, R.A. de; Koke, A.J.; Heuvel, W.J.A. van den
2006-01-01
OBJECTIVE: The intervention process was evaluated in a randomised clinical trial on the effectiveness of a behavioural Graded Exercise Therapy (GET) programme for patients with chronic shoulder complaints in primary care settings. This process evaluation was done for three reasons: first, to know
2015-01-01
Background Excessive alcohol use is a prevalent and worldwide problem. Excessive drinking causes a significant burden of disease and is associated with both morbidity and excess mortality. Prototype alteration and provision of a cue reminder could be useful strategies to enhance the effectiveness of online tailored interventions for excessive drinking. Objective Through a Web-based randomized controlled trial, 2 strategies (ie, prototype alteration and cue reminders) within an existing online personalized feedback intervention (Drinktest) aimed to reduce adults’ excessive drinking. It was expected that both strategies would add to Drinktest and would result in reductions in alcohol consumption by intrinsic motivation and the seizure of opportunities to act. Methods Participants were recruited online and through printed materials. Excessive drinking adults (N=2634) were randomly assigned to 4 conditions: original Drinktest, Drinktest plus prototype alteration, Drinktest plus cue reminder, and Drinktest plus prototype alteration and cue reminder. Evaluation took place at 1-month posttest and 6-month follow-up. Differences in drinking behavior, intentions, and behavioral willingness (ie, primary outcomes) were assessed by means of longitudinal multilevel analyses using a last observation carried forward method. Measures were based on self-reports. Results All conditions showed reductions in drinking behavior and willingness to drink, and increased intentions to reduce drinking. Prototype alteration (B=–0.15, Pprototypes. Thus, prototype alteration and cue reminder usage may be feasible and simple intervention strategies to promote reductions in alcohol consumption among adults, with an effect up to 6 months. Trial Registration Nederlands Trial Register (NTR): 4169; http://www.trialregister.nl/trialreg/admin/rctview.asp?TC=4169 (Archived by WebCite at http://www.webcitation.org/6VD2jnxmB). PMID:25653199
Directory of Open Access Journals (Sweden)
Curran Janet A
2013-02-01
Full Text Available Abstract Background The Canadian CT Head Rule was prospectively derived and validated to assist clinicians with diagnostic decision-making regarding the use of computed tomography (CT in adult patients with minor head injury. A recent intervention trial failed to demonstrate a decrease in the rate of head CTs following implementation of the rule in Canadian emergency departments. Yet, the same intervention, which included a one-hour educational session and reminders at the point of requisition, was successful in reducing cervical spine imaging rates in the same emergency departments. The reason for the varied effect of the intervention across these two behaviours is unclear. There is an increasing appreciation for the use of theory to conduct process evaluations to better understand how strategies are linked with outcomes in implementation trials. The Theoretical Domains Framework (TDF has been used to explore health professional behaviour and to design behaviour change interventions but, to date, has not been used to guide a theory-based process evaluation. In this proof of concept study, we explored whether the TDF could be used to guide a retrospective process evaluation to better understand emergency physicians’ responses to the interventions employed in the Canadian CT Head Rule trial. Methods A semi-structured interview guide, based on the 12 domains from the TDF, was used to conduct telephone interviews with project leads and physician participants from the intervention sites in the Canadian CT Head Rule trial. Two reviewers independently coded the anonymised interview transcripts using the TDF as a coding framework. Relevant domains were identified by: the presence of conflicting beliefs within a domain; the frequency of beliefs; and the likely strength of the impact of a belief on the behaviour. Results Eight physicians from four of the intervention sites in the Canadian CT Head Rule trial participated in the interviews. Barriers
International Nuclear Information System (INIS)
Chen, Yu-Pei; Chen, Lei; Li, Wen-Fei; Lee, Anne W.M.; Vermorken, Jan B.; Wee, Joseph; O'Sullivan, Brian; Eisbruch, Avraham; Lin, Jin-Ching; Mai, Hai-Qiang; Zhang, Li; Guo, Ying; Lin, Ai-Hua; Sun, Ying
2017-01-01
Purpose: To comprehensively assess the reporting quality of randomized, controlled trials (RCTs) in nasopharyngeal carcinoma (NPC), and to identify significant predictors of quality. Methods and Materials: Two investigators searched MEDLINE and EMBASE for RCTs published between January 1988 and December 2015 that assessed the effect of combined chemoradiotherapy for NPC. The overall quality of each report was assessed using a 28-point overall quality score (OQS) based on the 2010 Consolidated Standards of Reporting Trials (CONSORT) statement. To provide baseline data for further evaluation, we also investigated the reporting quality of certain important issues in detail, including key methodologic items (allocation concealment, blinding, intention-to-treat principle), endpoints, follow-up, subgroup analyses, and adverse events. Results: We retrieved 24 relevant RCTs including 6591 patients. Median 2010 OQS was 15.5 (range, 10-24). Half of the items in the 2010 OQS were poorly reported in at least 40% of trials. Multivariable regression models revealed that publication after 2010 and high impact factor were significant predictors of improved 2010 OQS. Additionally, many issues that we consider significant were not reported adequately. Conclusions: Despite publication of the CONSORT statement more than a decade ago, overall reporting quality for RCTs in NPC was unsatisfactory. Additionally, substantial selectivity and heterogeneity exists in reporting of certain crucial issues. This survey provides the first prompt for NPC trial investigators to improve reporting quality according to the CONSORT statement; increased scrutiny and diligence by editors and peer reviewers is also required.
Energy Technology Data Exchange (ETDEWEB)
Chen, Yu-Pei; Chen, Lei; Li, Wen-Fei [Department of Radiation Oncology, Sun Yat-sen University Cancer Centre, State Key Laboratory of Oncology in South China, Collaborative Innovation Centre of Cancer Medicine, Guangzhou (China); Lee, Anne W.M. [Department of Clinical Oncology, The University of Hong Kong-Shenzhen Hospital, Shenzhen (China); Vermorken, Jan B. [Department of Medical Oncology, Antwerp University Hospital, Edegem (Belgium); Wee, Joseph [Department of Radiation Oncology, National Cancer Centre Singapore (Singapore); O' Sullivan, Brian [Department of Radiation Oncology, University of Toronto, Ontario Cancer Institute, University Health Network, Toronto, Ontario (Canada); Eisbruch, Avraham [Department of Radiation Oncology, University of Michigan, Ann Arbor, Michigan (United States); Lin, Jin-Ching [Department of Radiation Oncology, Taichung Veterans General Hospital, Taichung, Taiwan (China); Mai, Hai-Qiang [Department of Nasopharyngeal Carcinoma, Sun Yat-sen University Cancer Centre, State Key Laboratory of Oncology in South China, Collaborative Innovation Centre of Cancer Medicine, Guangzhou (China); Zhang, Li [Department of Medical Oncology, Sun Yat-sen University Cancer Centre, State Key Laboratory of Oncology in South China, Collaborative Innovation Centre of Cancer Medicine, Guangzhou (China); Guo, Ying [Clinical Trials Centre, Sun Yat-sen University Cancer Centre, State Key Laboratory of Oncology in South China, Collaborative Innovation Centre of Cancer Medicine, Guangzhou (China); Lin, Ai-Hua [Department of Medical Statistics and Epidemiology, School of Public Health, Sun Yat-sen University, Guangzhou (China); Sun, Ying [Department of Radiation Oncology, Sun Yat-sen University Cancer Centre, State Key Laboratory of Oncology in South China, Collaborative Innovation Centre of Cancer Medicine, Guangzhou (China); and others
2017-05-01
Purpose: To comprehensively assess the reporting quality of randomized, controlled trials (RCTs) in nasopharyngeal carcinoma (NPC), and to identify significant predictors of quality. Methods and Materials: Two investigators searched MEDLINE and EMBASE for RCTs published between January 1988 and December 2015 that assessed the effect of combined chemoradiotherapy for NPC. The overall quality of each report was assessed using a 28-point overall quality score (OQS) based on the 2010 Consolidated Standards of Reporting Trials (CONSORT) statement. To provide baseline data for further evaluation, we also investigated the reporting quality of certain important issues in detail, including key methodologic items (allocation concealment, blinding, intention-to-treat principle), endpoints, follow-up, subgroup analyses, and adverse events. Results: We retrieved 24 relevant RCTs including 6591 patients. Median 2010 OQS was 15.5 (range, 10-24). Half of the items in the 2010 OQS were poorly reported in at least 40% of trials. Multivariable regression models revealed that publication after 2010 and high impact factor were significant predictors of improved 2010 OQS. Additionally, many issues that we consider significant were not reported adequately. Conclusions: Despite publication of the CONSORT statement more than a decade ago, overall reporting quality for RCTs in NPC was unsatisfactory. Additionally, substantial selectivity and heterogeneity exists in reporting of certain crucial issues. This survey provides the first prompt for NPC trial investigators to improve reporting quality according to the CONSORT statement; increased scrutiny and diligence by editors and peer reviewers is also required.
Roberts-Gray, Cindy; Sweitzer, Sara J; Ranjit, Nalini; Potratz, Christa; Rood, Magdalena; Romo-Palafox, Maria Jose; Byrd-Williams, Courtney E; Briley, Margaret E; Hoelscher, Deanna M
2017-08-01
A cluster-randomized trial at 30 early care and education centers (Intervention = 15, waitlist Control = 15) showed the Lunch Is in the Bag intervention increased parents' packing of fruits, vegetables, and whole grains in their preschool children's bag lunches (parent-child dyads = 351 Intervention, 282 Control). To examine the utility of structuring the trial's process evaluation to forecast use, sustainability, and readiness of the intervention for wider dissemination and implementation. Pretrial, the research team simulated user experience to forecast use of the intervention. Multiattribute evaluation of user experience measured during the trial assessed use and sustainability of the intervention. Thematic analysis of posttrial interviews with users evaluated sustained use and readiness for wider dissemination. Moderate use was forecast by the research team. Multiattribute evaluation of activity logs, surveys, and observations during the trial indicated use consistent with the forecast except that prevalence of parents reading the newsletters was greater (83% vs. 50%) and hearing their children talk about the classroom was less (4% vs. 50%) than forecast. Early care and education center-level likelihood of sustained use was projected to be near zero. Posttrial interviews indicated use was sustained at zero centers. Structuring the efficacy trial's process evaluation as a progression of assessments of user experience produced generally accurate forecasts of use and sustainability of the intervention at the trial sites. This approach can assist interpretation of trial outcomes, aid decisions about dissemination of the intervention, and contribute to translational science for improving health.
Cheng, Steven K; Dietrich, Mary S; Dilts, David M
2010-11-15
Postactivation barriers to oncology clinical trial accruals are well documented; however, potential barriers prior to trial opening are not. We investigate one such barrier: trial development time. National Cancer Institute Cancer Therapy Evaluation Program (CTEP)-sponsored trials for all therapeutic, nonpediatric phase I, I/II, II, and III studies activated between 2000 and 2004 were investigated for an 8-year period (n = 419). Successful trials were those achieving 100% of minimum accrual goal. Time to open a study was the calendar time from initial CTEP submission to trial activation. Multivariate logistic regression analysis was used to calculate unadjusted and adjusted odds ratios (OR), controlling for study phase and size of expected accruals. Among the CTEP-approved oncology trials, 37.9% (n = 221) failed to attain the minimum accrual goals, with 70.8% (n = 14) of phase III trials resulting in poor accrual. A total of 16,474 patients (42.5% of accruals) accrued to those studies were unable to achieve the projected minimum accrual goal. Trials requiring less than 12 months of development were significantly more likely to achieve accrual goals (OR, 2.15; 95% confidence interval, 1.29-3.57, P = 0.003) than trials with the median development times of 12 to 18 months. Trials requiring a development time of greater than 24 months were significantly less likely to achieve accrual goals (OR, 0.40; 95% confidence interval, 0.20-0.78; P = 0.011) than trials with the median development time. A large percentage of oncology clinical trials do not achieve minimum projected accruals. Trial development time appears to be one important predictor of the likelihood of successfully achieving the minimum accrual goals. ©2010 AACR.
The Results of a Randomized Control Trial Evaluation of the SPARK Literacy Program
Jones, Curtis J.; Christian, Michael; Rice, Andrew
2016-01-01
The purpose of this report is to present the results of a two-year randomized control trial evaluation of the SPARK literacy program. SPARK is an early grade literacy program developed by Boys & Girls Clubs of Greater Milwaukee. In 2010, SPARK was awarded an Investing in Innovation (i3) Department of Education grant to further develop the…
van Zijl, Floris V W J; Timman, Reinier; Datema, Frank R
2017-06-01
The nasal obstruction symptom evaluation (NOSE) scale is a validated disease-specific, self-completed questionnaire for the assessment of quality of life related to nasal obstruction. The aim of this study was to validate the Dutch (NL-NOSE) questionnaire. A prospective instrument validation study was performed in a tertiary academic referral center. Guidelines for the cross-cultural adaptation process from the original English language scale into a Dutch language version were followed. Patients undergoing functional septoplasty or septorhinoplasty and asymptomatic controls completed the questionnaire both before and 3 months after surgery to test reliability and validity. Additionally, we explored the possibility to reduce the NOSE scale even further using graded response models. 129 patients and 50 controls were included. Internal consistency (Cronbach's alpha 0.82) and test-retest reliability (intraclass correlation coefficient 0.89) were good. The instrument showed excellent between-group discrimination (Mann-Whitney U = 85, p Dutch version of the NOSE (NL-NOSE) demonstrated satisfactory reliability and validity. We recommend the use of the NL-NOSE as a validated instrument to measure subjective severity of nasal obstruction in Dutch adult patients.
[Delivery after a previous cesarean in the Gyneco-Obsteric Hospital Garza Garcia, N.L].
de la Garza Quintanilla, C; Celaya Juárez, J A; Hernández Escobar, C
1997-04-01
One hundred and four patients who delivered after a previous cesarean section, at Hospital de Ginecoobstetricia de Garza García, N.L., from February 1, 1994 to January 31, 1995, were reviewed. The objective for this study was to know materno-fetal morbi-mortality at our hospital. Age, parity weeks of gestation, cause for previous section, delivery culmination, weight and Apgar of products, as well as, materno-fetal morbi-mortality, were analyzed. Average age group was 21 to 30 years with 68.5%. As to parity nulliparae predominated with 48.1%. As to weeks of gestation, the most frequent was 37 to 40 weeks, 85.5%. Previous section indication was: 1. Pelvic presentation, 2. Fetal stress, 3. Cefalo-pelvic disproportion, 4. Premature rupture of membranes, 5. Toxemia. As to deliveries outcome, there was dystocia in 86.5%, by profilactic low forceps application in 81.7%; and mid low in 4.8%. Eutocic delivery, 13.5%. Product weight was 3,000 to 3,500 g, with 51%. Apgar in 94 products was 8 and 9 at one minute. Maternal morbidity was 15.3% being most frequent vaginal tears. There was one case of uterine atonia, and one case of dura mater adverted puncture. There were no uterine dehiscence nor rupture. Perinatal morbidity was 5.6%. There was no perinatal death.
Phase II trial to evaluate the ActiGait implanted drop-foot stimulator in established hemiplegia
DEFF Research Database (Denmark)
Burridge, Jane H; Haugland, Morten; Pickering, Ruth M
2007-01-01
OBJECTIVE: To evaluate a selective implantable drop foot stimulator (ActiGait) in terms of effect on walking and safety. DESIGN: A phase II trial in which a consecutive sample of participants acted as their own controls. SUBJECTS: People who had suffered a stroke at least 6 months prior to recrui......OBJECTIVE: To evaluate a selective implantable drop foot stimulator (ActiGait) in terms of effect on walking and safety. DESIGN: A phase II trial in which a consecutive sample of participants acted as their own controls. SUBJECTS: People who had suffered a stroke at least 6 months prior...... to recruitment and had a drop-foot that affected walking were recruited from 3 rehabilitation centres in Denmark. METHODS: Stimulators were implanted into all participants. Outcome measures were range of ankle dorsiflexion with stimulation and maximum walking speed and distance walked in 4 minutes. Measurements...
Murdoch, Jamie; Varley, Anna; Fletcher, Emily; Britten, Nicky; Price, Linnie; Calitri, Raff; Green, Colin; Lattimer, Valerie; Richards, Suzanne H; Richards, David A; Salisbury, Chris; Taylor, Rod S; Campbell, John L
2015-04-10
Telephone triage represents one strategy to manage demand for face-to-face GP appointments in primary care. However, limited evidence exists of the challenges GP practices face in implementing telephone triage. We conducted a qualitative process evaluation alongside a UK-based cluster randomised trial (ESTEEM) which compared the impact of GP-led and nurse-led telephone triage with usual care on primary care workload, cost, patient experience, and safety for patients requesting a same-day GP consultation. The aim of the process study was to provide insights into the observed effects of the ESTEEM trial from the perspectives of staff and patients, and to specify the circumstances under which triage is likely to be successfully implemented. Here we report perspectives of staff. The intervention comprised implementation of either GP-led or nurse-led telephone triage for a period of 2-3 months. A qualitative evaluation was conducted using staff interviews recruited from eight general practices (4 GP triage, 4 Nurse triage) in the UK, implementing triage as part of the ESTEEM trial. Qualitative interviews were undertaken with 44 staff members in GP triage and nurse triage practices (16 GPs, 8 nurses, 7 practice managers, 13 administrative staff). Staff reported diverse experiences and perceptions regarding the implementation of telephone triage, its effects on workload, and on the benefits of triage. Such diversity were explained by the different ways triage was organised, the staffing models used to support triage, how the introduction of triage was communicated across practice staff, and by how staff roles were reconfigured as a result of implementing triage. The findings from the process evaluation offer insight into the range of ways GP practices participating in ESTEEM implemented telephone triage, and the circumstances under which telephone triage can be successfully implemented beyond the context of a clinical trial. Staff experiences and perceptions of telephone
LENUS (Irish Health Repository)
Niemeyer, Charlotte M
2015-01-01
Juvenile myelomonocytic leukemia is a rare myeloproliferative disease in young children. While hematopoietic stem cell transplantation remains the only curative therapeutic option for most patients, children with juvenile myelomonocytic leukemia increasingly receive novel agents in phase I-II clinical trials as pre-transplant therapy or therapy for relapse after transplantation. However, response criteria or definitions of outcome for standardized evaluation of treatment effect in patients with juvenile myelomonocytic leukemia are currently lacking. Here we propose criteria to evaluate the response to the non-transplant therapy and definitions of remission status after hematopoietic stem cell transplantation. For the evaluation of non-transplant therapy, we defined 6 clinical variables (white blood cell count, platelet count, hematopoietic precursors and blasts in peripheral blood, bone marrow blast percentage, spleen size and extramedullary disease) and 3 genetic variables (cytogenetic, molecular and chimerism response) which serve to describe the heterogeneous picture of response to therapy in each individual case. It is hoped that these criteria will facilitate the comparison of results between clinical trials in juvenile myelomonocytic leukemia.
Osmaniye’de Günlük Toplam Güneş Işınım Ölçümleri
Directory of Open Access Journals (Sweden)
Muhittin ŞAHAN
2015-11-01
Full Text Available Özet: Bu çalışmada, güneşten gelen toplam ışınımı ölçmek amacıyla OKÜMERLAB (Osmaniye Korkut Ata Üniversitesi Merkezi Laboratuvarı, En: 37.04227 N; Boy:36.22134 E, Osmaniye/Türkiye binasının çatı katına yerleştirilen Eppley Black and White Pyranometer(Model 8-48 ölçüm cihazı kullanılmıştır. Bir yıl boyunca (Mayıs 2013 – Nisan 2014 dakikalık olarak milivolt cinsinden alınan veriler kişisel bir bilgisayar yardımıyla saatlik, günlük ve aylık olarak W/m2 cinsinden enerji birimine dönüştürülmüştür. Yatay yüzeye gelen toplam ışınım 1662322.88W/m2 olarak hesaplanmıştır. Günlük toplam global güneş ışınımının aylık ortalama değerleri 4755.43 W/m2 olarak ölçülmüştür. Ayrıca, günlük ortalama global güneş ışınımı 396.29 W/m2 olarak bulunmuştur. En yüksek toplam ışınım değerleri haziran ayında 528.33W/m2ölçülürken en düşük toplam değerleri sırasıyla 201.23 W/m2olarak aralık ayında ölçülmüştür. Anahtar kelimeler: Güneş Işınımı, toplam ışınım, Akdeniz bölgesi Daily Global Solar Radiation Measurements in Osmaniye Abstract: In this study, Eppley Black and White Pyranometer (Model 8-48 instrument located on the roof of OKUMERLAB (Central Laboratory of Osmaniye Korkut Ata University, Lat: 37.04227 N; Long: 36.22134 E, Osmaniye/Turkey was used to measure solar global radiation. The data received in minutes in terms of millivolts during one year period (May 2013 to April 2014 were converted to energy unit as hourly, daily and monthly in terms of W/m2 using a personal computer. Daily total global radiation on a horizontal surface was calculated as1662322.88 W/m2. Values of monthly average of daily global solar was measured as4755.43 W/m2. It was also found that the average daily total radiation wasas396.29 W/m2. While the highest global solar radiation was obtained in June to be 528.33W/m2, the lowest values were obtained in
Quayyum, Zahidul; Briggs, Andrew; Robles-Zurita, Jose; Oldroyd, Keith; Zeymer, Uwe; Desch, Steffen; Waha, Suzanne de; Thiele, Holger
2017-08-18
Emergency percutaneous coronary intervention (PCI) of the culprit lesion for patients with acute myocardial infarctions is an accepted practice. A majority of patients present with multivessel disease with additional relevant stenoses apart from the culprit lesion. In haemodynamically stable patients, there is increasing evidence from randomised trials to support the practice of immediate complete revascularisation. However, in the presence of cardiogenic shock, the optimal management strategy for additional non-culprit lesions is unknown. A multicentre randomised controlled trial, CULPRIT-SHOCK, is examining whether culprit vessel only PCI with potentially subsequent staged revascularisation is more effective than immediate multivessel PCI. This paper describes the intended economic evaluation of the trial. The economic evaluation will be conducted using a pre-trial decision model and within-trial analysis. The modelling-based analysis will provide expected costs and health outcomes, and incremental cost-effectiveness ratio over the lifetime for the cohort of patients included in the trial. The within-trial analysis will provide estimates of cost per life saved at 30 days and in 1 year, and estimates of health-related quality of life. Bootstrapping and cost-effectiveness acceptability curves will be used to address any uncertainty around these estimates. Different types of regression models within a generalised estimating equation framework will be used to examine how the total cost and quality-adjusted life years are explained by patients' characteristics, revascularisation strategy, country and centre. The cost-effectiveness analysis will be from the perspective of each country's national health services, where costs will be expressed in euros adjusted for purchasing power parity. Ethical approval for the study was granted by the local Ethics Committee at each recruiting centre. The economic evaluation analyses will be published in peer-reviewed journals of
van Teeffelen, Augustinus S P; van der Ham, David P; Willekes, Christine; Al Nasiry, Salwan; Nijhuis, Jan G; van Kuijk, Sander; Schuyt, Ewoud; Mulder, Twan L M; Franssen, Maureen T M; Oepkes, Dick; Jansen, Fenna A R; Woiski, Mallory D; Bekker, Mireille N; Bax, Caroline J; Porath, Martina M; de Laat, Monique W M; Mol, Ben W; Pajkrt, Eva
2014-04-04
Babies born after midtrimester preterm prelabour rupture of membranes (PPROM) are at risk to develop neonatal pulmonary hypoplasia. Perinatal mortality and morbidity after this complication is high. Oligohydramnios in the midtrimester following PPROM is considered to cause a delay in lung development. Repeated transabdominal amnioinfusion with the objective to alleviate oligohydramnios might prevent this complication and might improve neonatal outcome. Women with PPROM and persisting oligohydramnios between 16 and 24 weeks gestational age will be asked to participate in a multi-centre randomised controlled trial. random allocation to (repeated) abdominal amnioinfusion (intervention) or expectant management (control). The primary outcome is perinatal mortality. Secondary outcomes are lethal pulmonary hypoplasia, non-lethal pulmonary hypoplasia, survival till discharge from NICU, neonatal mortality, chronic lung disease (CLD), number of days ventilatory support, necrotizing enterocolitis (NEC), periventricular leucomalacia (PVL) more than grade I, severe intraventricular hemorrhage (IVH) more than grade II, proven neonatal sepsis, gestational age at delivery, time to delivery, indication for delivery, successful amnioinfusion, placental abruption, cord prolapse, chorioamnionitis, fetal trauma due to puncture. The study will be evaluated according to intention to treat. To show a decrease in perinatal mortality from 70% to 35%, we need to randomise two groups of 28 women (two sided test, β-error 0.2 and α-error 0.05). This study will answer the question if (repeated) abdominal amnioinfusion after midtrimester PPROM with associated oligohydramnios improves perinatal survival and prevents pulmonary hypoplasia and other neonatal morbidities. Moreover, it will assess the risks associated with this procedure. NTR3492 Dutch Trial Register (http://www.trialregister.nl).
Carta do editor de edições especiais da Encontros Bibli 10.5007/1518-2924.2011v16nesp1piv
Directory of Open Access Journals (Sweden)
Francisco das Chagas de Souza
2011-06-01
Full Text Available Dos horizontes arquivísticos e de seu sentido É significativo observar que a discussão sobre Arquivologia e sobre as práticas profissionais arquivisticas tem avançado muito nos últimos anos no Brasil, e as razões são claramente apontadas pelos organizadores desta edição especial de Encontros Bibli em seu texto editorial. Contendo sete artigos, esta edição temática traz o título Horizontes Arquivísticos.Para dar vida a este número, foi desenvolvido um trabalho de quase dois anos, liderado pelo pesquisador José Maria Jardim e colaboração de Renata Silva Borges. Aqui estão reunidos nove autores e seis avaliadores, todos vinculados a instituições de ensino e de pesquisa ligadas ao Serviço Público Federal, com sede nas cidades de Brasilia, Rio de Janeiro, Niteroi e Florianópolis: UNB, UNIRIO, UFF, UFRJ, UFSC, Arquivo Nacional e FIOCRUZ.Neste momento da história brasileira ─ em que se anunciam políticas governamentais em prol da cidadania, em que se diz da disposição de resgate da verdade sobre os fatos políticos acontecidos na gestão do estado brasileiro dos anos de 1964 a 1989 ─ os arquivos e seus profissionais passam a divisar um relevante protagonismo. Pode-se dizer que, de certa maneira, deu-se um movimento de preparação deste protagonismo e que, simultaneamente, essa preparação alicerçou a percepção de segmentos importantes do setor público para oferecer essa perspectiva para a sociedade nacional.Nesse sentido, tem peso relevante a instalação de novos cursos de bacharelado na área, totalizando, em 2011, o número de 14 universidades que os oferecem: UNIRIO, UFF, UFSM, UFES, UNB, UEL, UFBA ,UNESP/MARÍLIA, UFRGS, UEPB, UFAM, FURG, UFMG, UFSC. Uma nota marcante é que todas essas Instituições de Ensino Superior têm vínculos governamentais, sendo onze federais e três estaduais. Esse movimento não se faz por outro caminho senão o da pesquisa histórica e social. Em áreas como a História, Educa
Boots, Lizzy Mm; de Vugt, Marjolein E; Smeets, Claudia Mj; Kempen, Gertrudis Ijm; Verhey, Frans Rj
2017-12-19
, time, and deviating target population. Participants and coaches were satisfied with the intervention, but adapting the content to specific subgroups, for example, younger caregivers, was recommended. Implementation of the program requires more awareness of the benefits of blended care self-management programs and training in tailored self-management skills. Dutch Trial Register (NTR): NTR4748; http://www.trialregister.nl (Archived by WebCite at http://www.webcitation.org/6vSb2t9Mg). ©Lizzy MM Boots, Marjolein E de Vugt, Claudia MJ Smeets, Gertrudis IJM Kempen, Frans RJ Verhey. Originally published in the Journal of Medical Internet Research (http://www.jmir.org), 19.12.2017.
Brinkman, Sally A; Johnson, Sarah E; Lawrence, David; Codde, James P; Hart, Michael B; Straton, Judith AY; Silburn, Sven
2010-01-01
Abstract Background This paper presents the study protocol for a pragmatic randomised controlled trial to evaluate the impact of a school based program developed to prevent teenage pregnancy. The program includes students taking care of an Infant Simulator; despite growing popularity and an increasing global presence of such programs, there is no published evidence of their long-term impact. The aim of this trial is to evaluate the Virtual Infant Parenting (VIP) program by investigating pre-c...
Iacoboni, G; Zucca, E; Ghielmini, M; Stathis, A
2018-05-01
The first-line treatment of diffuse large B-cell lymphoma (DLBCL) is the combination of rituximab with CHOP (cyclophosphamide, doxorubicin, vincristine, prednisone) chemotherapy, curing approximately 60% of patients. Many clinical trials have been carried out over the last 10 years trying to improve the results of this treatment, but the appropriateness of their planning strategies could be rediscussed. Reports of phase III trials evaluating the addition of molecularly targeted agents or new monoclonal antibodies to the classic R-CHOP backbone in first-line induction or maintenance treatment were reviewed. The trial design, primary end point, number of patients enrolled, patient selection criteria, treatment schedule and results were registered for each one. In addition, the phases I and II trials which preceded these phase III trials were also reviewed. Among six phase III trials with results, only one trial evaluating lenalidomide maintenance after response to R-CHOP induction was positive and reached its primary end point. The other five trials did not show an improved outcome with the addition of the new agent. The preceding phases I and II trials were very heterogeneous in their end points and design. Even though most of these trials were considered positive, thus encouraging further investigation, so far they failed to predict the results of the subsequent phase III trials. The standard of care for DLBCL is still R-CHOP. Phase I/II trials failed to predict the results of subsequent phase III trials evaluating non-chemotherapeutic agents added to R-CHOP. The methodology of phase II trials evaluating new agents in DLBCL needs to be better defined in the future.
Acosta, Joie D; Chinman, Matthew; Ebener, Patricia; Phillips, Andrea; Xenakis, Lea; Malone, Patrick S
2016-01-01
Restorative Practices in schools lack rigorous evaluation studies. As an example of rigorous school-based research, this paper describes the first randomized control trial of restorative practices to date, the Study of Restorative Practices. It is a 5-year, cluster-randomized controlled trial (RCT) of the Restorative Practices Intervention (RPI) in 14 middle schools in Maine to assess whether RPI impacts both positive developmental outcomes and problem behaviors and whether the effects persist during the transition from middle to high school. The two-year RPI intervention began in the 2014-2015 school year. The study's rationale and theoretical concerns are discussed along with methodological concerns including teacher professional development. The theoretical rationale and description of the methods from this study may be useful to others conducting rigorous research and evaluation in this area.
Patrice Loiez
1999-01-01
Dr. Hans Chang, Director, Physics Research Committee, Stichting voor Fundamenteel Onderzoek der Materie (FOM), Dr. Joris Van Enst, Head of Science Policy Division, Ministry of Education, Culture and S cience, Dr. Jan Bezemer, NL Delegate CERN, Netherlands
Gee Kee, E; Stockton, K; Kimble, R M; Cuttle, L; McPhail, S M
2017-06-01
Partial thickness burns of up to 10% total body surface area (TBSA) in children are common injuries primarily treated in the outpatient setting using expensive silver-containing dressings. However, economic evaluations in the paediatric burns population are lacking to assist healthcare providers when choosing which dressing to use. The aim of this study was to conduct a cost-effectiveness analysis of three silver dressings for partial thickness burns ≤10% TBSA in children aged 0-15 years using days to full wound re-epithelialization as the health outcome. This study was a trial based economic evaluation (incremental cost effectiveness) conducted from a healthcare provider perspective. Ninety-six children participated in the trial investigating Acticoat™, Acticoat™ with Mepitel™ or Mepilex Ag™. Costs directly related to the management of partial thickness burns ≤10% TBSA were collected during the trial from March 2013 to July 2014 and for a one year after re-epithelialization time horizon. Incremental cost effectiveness ratios were estimated and dominance probabilities calculated from bootstrap resampling trial data. Sensitivity analyses were conducted to examine the potential effect of accounting for infrequent, but high cost, skin grafting surgical procedures. Costs (dressing, labour, analgesics, scar management) were considerably lower in the Mepilex Ag™ group (median AUD$94.45) compared to the Acticoat™ (median $244.90) and Acticoat™ with Mepitel™ (median $196.66) interventions. There was a 99% and 97% probability that Mepilex Ag™ dominated (cheaper and more effective than) Acticoat™ and Acticoat™ with Mepitel™, respectively. This pattern of dominance was consistent across raw cost and effects, after a priori adjustments, and sensitivity analyses. There was an 82% probability that Acticoat™ with Mepitel dominated Acticoat™ in the primary analysis, although this probability was sensitive to the effect of skin graft procedures. This
Energy Technology Data Exchange (ETDEWEB)
John A. Sinsel
2003-06-30
Plant trial evaluations have been completed for two zirconium-based, non-chromium passivation systems previously identified as possible alternatives to cathodic dichromate (CDC) passivation for electrolytic tinplate (ETP). These trials were done on a commercial electrolytic tin plating line at Weirton Steel and extensive evaluations of the materials resulting from these trials have been completed. All this was accomplished as a collaborative effort under the AISI Technology Roadmap Program and was executed by seven North American Tin Mill Products producers [Bethlehem Steel (now acquired by International Steel Group (ISG)), Dofasco Inc., National Steel (now acquired by U.S. Steel), U.S. Steel, USS-Posco, Weirton Steel, and Wheeling-Pittsburgh Steel] with funding partially from the Department of Energy (DOE) and partially on an equal cost sharing basis among project participants. The initial phases of this project involved optimization of application procedures for the non-chromium systems in the laboratories at Bethlehem Steel and Betz Dearborn followed by extensive testing with various lacquer formulations and food simulants in the laboratories at Valspar and PPG. Work was also completed at Dofasco and Weirton Steel to develop methods to prevent precipitation of insoluble solids as a function of time from the zirconate system. The results of this testing indicated that sulfide staining characteristics for the non-chromium passivation systems could be minimized but not totally eliminated and neither system was found to perform quite as good, in this respect, as the standard CDC system. As for the stability of zirconate treatment, a method was developed to stabilize this system for a sufficient period of time to conduct plant trial evaluations but, working with a major supplier of zirconium orthosulfate, a method for long term stabilization is still under development.
Mei, Wending; Wang, Lu; Zang, Ying; Zheng, Zhaojuan; Ouyang, Jia
2016-06-30
L-arabinose isomerase (AI) is a crucial catalyst for the biotransformation of D-galactose to D-tagatose. In previous reports, AIs from thermophilic bacterial strains had been wildly researched, but the browning reaction and by-products formed at high temperatures restricted their applications. By contrast, AIs from mesophilic Bacillus strains have some different features including lower optimal temperatures and lower requirements of metallic cofactors. These characters will be beneficial to the development of a more energy-efficient and safer production process. However, the relevant data about the kinetics and reaction properties of Bacillus AIs in D-tagatose production are still insufficient. Thus, in order to support further applications of these AIs, a comprehensive characterization of a Bacillus AI is needed. The coding gene (1422 bp) of Bacillus coagulans NL01 AI (BCAI) was cloned and overexpressed in the Escherichia coli BL21 (DE3) strain. The enzymatic property test showed that the optimal temperature and pH of BCAI were 60 °C and 7.5 respectively. The raw purified BCAI originally showed high activity in absence of outsourcing metallic ions and its thermostability did not change in a low concentration (0.5 mM) of Mn(2+) at temperatures from 70 °C to 90 °C. Besides these, the catalytic efficiencies (k cat/K m) for L-arabinose and D-galactose were 8.7 mM(-1) min(-1) and 1.0 mM(-1) min(-1) respectively. Under optimal conditions, the recombinant E. coli cell containing BCAI could convert 150 g L(-1) and 250 g L(-1) D-galactose to D-tagatose with attractive conversion rates of 32 % (32 h) and 27 % (48 h). In this study, a novel AI from B. coagulans NL01was cloned, purified and characterized. Compared with other reported AIs, this AI could retain high proportions of activity at a broader range of temperatures and was less dependent on metallic cofactors such as Mn(2+). Its substrate specificity was understood deeply by carrying out molecular
Friederichs, Stijn; Bolman, Catherine; Oenema, Anke; Guyaux, Janneke; Lechner, Lilian
2014-02-13
Developing Web-based physical activity (PA) interventions based on motivational interviewing (MI) could increase the availability and reach of MI techniques for PA promotion. Integrating an avatar in such an intervention could lead to more positive appreciation and higher efficacy of the intervention, compared to an intervention that is purely text-based. The present study aims to determine whether a Web-based PA intervention based on MI with an avatar results in more positive appreciation and higher effectiveness of the intervention, when compared to an intervention that is purely text-based. A three-arm randomized controlled trial was conducted, containing the following research conditions: (1) a Web-based PA intervention based on MI with an avatar, (2) a content-identical intervention without an avatar, and (3) a control condition that received no intervention. Measurements included PA behavior and process variables, measured at baseline, directly following the intervention and 1 month post intervention. Both interventions significantly increased self-reported PA at 1 month, compared to the control condition (beta(AVATARvsCONTROL)=.39, P=.011; beta(TEXTvsCONTROL)=.44, P=.006). No distinctions were found regarding intervention effect on PA between both interventions. Similarly, the results of the process evaluation did not indicate any significant differences between both interventions. Due to the limited relational skills of the avatar in this study, it probably did not succeed in forming a stronger relationship with the user, over and above text alone. The findings suggest that avatars that do not strengthen the social relationship with the user do not enhance the intervention impact. Future research should determine whether Web-based PA interventions based on MI could benefit from inclusion of a virtual coach capable of more complex relational skills than used in the current study, such as responding in gesture to the user's state and input. Dutch Trial
Van Reijen, Miriam; Vriend, Ingrid I; Zuidema, Victor; van Mechelen, Willem; Verhagen, Evert A
2014-01-07
Ankle sprains continue to pose a significant burden to the individual athlete, as well as to society as a whole. However, despite ankle sprains being the single most common sports injury and despite an active approach by various Dutch organisations in implementing preventive measures, large-scale community uptake of these preventive measures, and thus actual prevention of ankle sprains, is lagging well behind. In an attempt to bridge this implementation gap, the Dutch Consumer Safety Institute VeiligheidNL developed a freely available interactive App ('Strenghten your ankle' translated in Dutch as: 'Versterk je enkel; available for iOS and Android) that contains - next to general advice on bracing and taping - a proven cost-effective neuromuscular program. The 'Strengthen your ankle' App has not been evaluated against the 'regular' prevention approach in which the neuromuscular program is advocated through written material. The aim of the current project is to evaluate the implementation value of the 'Strengthen your ankle' App as compared to the usual practice of providing injured athletes with written materials. In addition, as a secondary outcome measure, the cost-effectiveness will be assessed against usual practice. The proposed study will be a randomised controlled trial. After stratification for medical caregiver, athletes will be randomised to two study groups. One group will receive a standardized eight-week proprioceptive training program that has proven to be cost-effective to prevent recurrent ankle injuries, consisting of a balance board (machU/ MSG Europe BVBA), and a traditional instructional booklet. The other group will receive the same exercise program and balance board. However, for this group the instructional booklet is exchanged by the interactive 'Strengthen your ankle' App. This trial is the first randomized controlled trial to study the implementation effectiveness of an App for proprioceptive balance board training program in comparison to
Tanaka, Atsushi; Shimabukuro, Michio; Okada, Yosuke; Taguchi, Isao; Yamaoka-Tojo, Minako; Tomiyama, Hirofumi; Teragawa, Hiroki; Sugiyama, Seigo; Yoshida, Hisako; Sato, Yasunori; Kawaguchi, Atsushi; Ikehara, Yumi; Machii, Noritaka; Maruhashi, Tatsuya; Shima, Kosuke R; Takamura, Toshinari; Matsuzawa, Yasushi; Kimura, Kazuo; Sakuma, Masashi; Oyama, Jun-Ichi; Inoue, Teruo; Higashi, Yukihito; Ueda, Shinichiro; Node, Koichi
2017-04-12
empagliflozin-mediated actions with endothelial function and other CV markers will be evaluated. Thus, the trial is designed to elucidate potential mechanisms by which empagliflozin protects CV systems and improves CV outcomes. Trial registration Unique Trial Number, UMIN000024502 ( https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028197 ).
Trial-to-Trial Carryover in Auditory Short-Term Memory
Visscher, Kristina M.; Kahana, Michael J.; Sekuler, Robert
2009-01-01
Using a short-term recognition memory task, the authors evaluated the carryover across trials of 2 types of auditory information: the characteristics of individual study sounds (item information) and the relationships between the study sounds (study set homogeneity). On each trial, subjects heard 2 successive broadband study sounds and then…
Vandermeer, Ben; van der Tweel, Ingeborg; Jansen-van der Weide, Marijke C.; Weinreich, Stephanie S.; Contopoulos-Ioannidis, Despina G.; Bassler, Dirk; Fernandes, Ricardo M.; Askie, Lisa; Saloojee, Haroon; Baiardi, Paola; Ellenberg, Susan S.; van der Lee, Johanna H.
2018-01-01
Background: We wished to compare the nuisance parameters of pediatric vs. adult randomized-trials (RCTs) and determine if the latter can be used in sample size computations of the former. Methods: In this meta-epidemiologic empirical evaluation we examined meta-analyses from the Cochrane Database of
Directory of Open Access Journals (Sweden)
Kyung-Shin Kim
2018-03-01
Full Text Available This study was designed to analyze the feasibility of economic aspects assuming that the policy of diaper recycling is necessary. With respect to economic feasibility, the collection and transportation of the diaper waste, which accounts for much of the cost, need to be optimized. Starting with the results of a collection trial in Scotland (2012, the method used in a collection trial in Korea (2014 was analyzed to identify problems incurring additional costs. This paper targeted daycare centers in Nowon-Gu, Seoul—because of the quantity of waste diapers they produce and the efficiency of collection—to identify the problems and to predict the cost of collection. This study evaluated multiple scenarios in light of their collection costs, discovering factors that could improve the system and reduce the cost and created the most economically feasible and optimized collection model. This paper will serve as empirical evidence proving the economics of diaper collection when the regulation is revised or amended in the future.
International Nuclear Information System (INIS)
Sundaresan, Puma; Turner, Sandra; Kneebone, Andrew; Pearse, Maria; Butow, Phyllis
2011-01-01
Randomised controlled trials (RCTs) can be hampered by poor patient accrual and retention. Decision aids (DAs) containing simple, evidence-based information, may assist patients with decision-making regarding trial participation. The current DA was of use for 95% of participants. Further evaluation of the DA in a RCT is currently underway.
Wang, Jun-xiang; Yan, Yan; Wang, Xiu-jing
2012-11-01
Enamel decalcification in orthodontics is a concern for dentists and methods to remineralize these lesions are the focus of intense research. The aim of this study was to evaluate the remineralizing effect of casein phosphopeptide amorphous calcium phosphate (CPP-ACP) nanocomplexes on enamel decalcification in orthodontics. Twenty orthodontic patients with decalcified enamel lesions during fixed orthodontic therapy were recruited to this study as test group and twenty orthodontic patients with the similar condition as control group. GC Tooth Mousse, the main component of which is CPP-ACP, was used by each patient of test group every night after tooth-brushing for six months. For control group, each patient was asked to brush teeth with toothpaste containing 1100 parts per million (ppm) of fluoride twice a day. Standardized intraoral images were taken for all patients and the extent of enamel decalcification was evaluated before and after treatment over this study period. Measurements were statistically compared by t test. After using CPP-ACP for six months, the enamel decalcification index (EDI) of all patients had decreased; the mean EDI before using CPP-ACP was 0.191 ± 0.025 and that after using CPP-ACP was 0.183 ± 0.023, the difference was significant (t = 5.169, P 0.05). CPP-ACP can effectively improve the demineralized enamel lesions during orthodontic treatment, so it has some remineralization potential for enamel decalcification in orthodontics.
Directory of Open Access Journals (Sweden)
Burgers Jako
2011-05-01
Full Text Available Abstract Background Public priorities for improvement often differ from those of clinicians and managers. Public involvement has been proposed as a way to bridge the gap between professional and public clinical care priorities but has not been studied in the context of quality-indicator choice. Our objective is to assess the feasibility and impact of public involvement on quality-indicator choice and agreement with public priorities. Methods We will conduct a cluster randomised controlled trial comparing quality-indicator prioritisation with and without public involvement. In preparation for the trial, we developed a 'menu' of quality indicators, based on a systematic review of existing validated indicator sets. Participants (public representatives, clinicians, and managers will be recruited from six participating sites. In intervention sites, public representatives will be involved through direct participation (public representatives, clinicians, and managers will deliberate together to agree on quality-indicator choice and use and consultation (individual public recommendations for improvement will be collected and presented to decision makers. In control sites, only clinicians and managers will take part in the prioritisation process. Data on quality-indicator choice and intended use will be collected. Our primary outcome will compare quality-indicator choice and agreement with public priorities between intervention and control groups. A process evaluation based on direct observation, videorecording, and participants' assessment will be conducted to help explain the study's results. The marginal cost of public involvement will also be assessed. Discussion We identified 801 quality indicators that met our inclusion criteria. An expert panel agreed on a final set of 37 items containing validated quality indicators relevant for chronic disease prevention and management in primary care. We pilot tested our public-involvement intervention with 27
Zheng, Zhaojuan; Lin, Xi; Jiang, Ting; Ye, Weihua; Ouyang, Jia
2016-08-01
To investigate the xylose operon and properties of xylose isomerase and xylulokinase in Bacillus coagulans that can effectively ferment xylose to lactic acid. The xylose operon is widely present in B. coagulans. It is composed of four putative ORFs. Novel xylA and xylB from B. coagulans NL01 were cloned and expressed in Escherichia coli. Sequence of xylose isomerase was more conserved than that of xylulokinase. Both the enzymes exhibited maximum activities at pH 7-8 but with a high temperature maximum of 80-85 °C, divalent metal ion was prerequisite for their activation. Xylose isomerase and xylulokinase were most effectively activated by Ni(2+) and Co(2+), respectively. Genomic analysis of xylose operon has contributed to understanding xylose metabolism in B. coagulans and the novel xylose isomerase and xylulokinase might provide new alternatives for metabolic engineering of other strains to improve their fermentation performance on xylose.
Evaluation of web-based annotation of ophthalmic images for multicentric clinical trials.
Chalam, K V; Jain, P; Shah, V A; Shah, Gaurav Y
2006-06-01
An Internet browser-based annotation system can be used to identify and describe features in digitalized retinal images, in multicentric clinical trials, in real time. In this web-based annotation system, the user employs a mouse to draw and create annotations on a transparent layer, that encapsulates the observations and interpretations of a specific image. Multiple annotation layers may be overlaid on a single image. These layers may correspond to annotations by different users on the same image or annotations of a temporal sequence of images of a disease process, over a period of time. In addition, geometrical properties of annotated figures may be computed and measured. The annotations are stored in a central repository database on a server, which can be retrieved by multiple users in real time. This system facilitates objective evaluation of digital images and comparison of double-blind readings of digital photographs, with an identifiable audit trail. Annotation of ophthalmic images allowed clinically feasible and useful interpretation to track properties of an area of fundus pathology. This provided an objective method to monitor properties of pathologies over time, an essential component of multicentric clinical trials. The annotation system also allowed users to view stereoscopic images that are stereo pairs. This web-based annotation system is useful and valuable in monitoring patient care, in multicentric clinical trials, telemedicine, teaching and routine clinical settings.
Drossaert, Constance HC; Pieterse, Marcel E; Walburg, Jan A; Bohlmeijer, Ernst T
2015-01-01
Background Positive psychology interventions have been found to enhance well-being and decrease clinical symptomatology. However, it is still unknown how flourishing can also be increased. Although multicomponent interventions seem to be necessary for this purpose, different formats can be used. A cost-effective approach could be a positive psychology-based self-help book with tailored email support to reach large target groups and to prevent dropout. Objective This study will evaluate the efficacy of a comprehensive multicomponent self-help intervention with or without email support on well-being and flourishing, and will seek to determine the working mechanisms underlying the intervention. Methods In this 3-armed, parallel, randomized controlled trial, 396 participants with low or moderate levels of well-being and without clinical symptomatology will be randomly assigned to (1) a self-help book condition with weekly email support, (2) a self-help book condition without email support but with a weekly information email, or (3) a waiting list control condition. Online measurements will be assessed at baseline, at post-test (3 months after baseline), and at 6 and 12 months after baseline. Results The primary outcomes are well-being and flourishing (ie, high levels of well-being). Secondary outcomes are the well-being components included in the intervention: positive emotion, use of strengths, optimism, self-compassion, resilience, and positive relations. Other measures include depressive and anxiety symptoms, personality traits, direct medical and non-medical costs, life-events, and client satisfaction. Conclusions This study will add knowledge to the efficacy and cost-effectiveness of a multicomponent positive psychology intervention. We will also explore who can benefit most from this intervention. If the intervention is found to be effective, our results will be especially relevant for public mental health services, governments, and primary care. Trial
Directory of Open Access Journals (Sweden)
Mackintosh Shylie F
2009-03-01
Full Text Available Abstract Background Falls are common in stroke survivors returning home after rehabilitation, however there is currently a lack of evidence about preventing falls in this population. This paper describes the study protocol for the FLASSH (FaLls prevention After Stroke Survivors return Home project. Methods and design This randomised controlled trial aims to evaluate the effectiveness of a multi-factorial falls prevention program for stroke survivors who are at high risk of falling when they return home after rehabilitation. Intervention will consist of a home exercise program as well as individualised falls prevention and injury minimisation strategies based on identified risk factors for falls. Additionally, two sub-studies will be implemented in order to explore other key areas related to falls in this population. The first of these is a longitudinal study evaluating the relationship between fear of falling, falls and function over twelve months, and the second evaluates residual impairment in gait stability and obstacle crossing twelve months after discharge from rehabilitation. Discussion The results of the FLASSH project will inform falls prevention practice for stroke survivors. If the falls prevention program is shown to be effective, low cost strategies to prevent falls can be implemented for those at risk around the time of discharge from rehabilitation, thus improving safety and quality of life for stroke survivors. The two sub-studies will contribute to the overall understanding and management of falls risk in stroke survivors. Trial registration This trial is registered with the Australian and New Zealand Clinical Trials Registry (ACTRN012607000398404.
Directory of Open Access Journals (Sweden)
Ohmann Christian
2010-10-01
Full Text Available Abstract Background Despite the high prevalence of subthreshold depression in patients with type 2 diabetes, evidence on cost-effectiveness of different therapy options for these patients is currently lacking. Methods/Design Within-trial economic evaluation of the diabetes-specific cognitive behaviour therapy for subthreshold depression. Patients with diabetes and subthreshold depression are randomly assigned to either 2 weeks of diabetes-specific cognitive behaviour group therapy (n = 104 or to standard diabetes education programme only (n = 104. Patients are followed for 12 months. During this period data on total health sector costs, patient costs and societal productivity costs are collected in addition to clinical data. Health related quality of life (the SF-36 and the EQ-5D is measured at baseline, immediately after the intervention, at 6 and at 12 months after the intervention. Quality adjusted life years (QALYs, and cumulative costs will be estimated for each arm of the trial. Cost-effectiveness of the diabetes-specific cognitive behaviour group therapy will be analysed from the perspective of the German statutory health insurance and from the societal perspective. To this end, incremental cost-effectiveness ratio (ICER in terms of cost per QALY gained will be calculated. Discussion Some methodological issues of the described economic evaluation are discussed. Trial registration The trial has been registered at the Clinical Trials Register (NCT01009138.
77 FR 57090 - Agency Information Collection Activities: Proposed Collection; Comment Request
2012-09-17
...: Medicare Electronic Data Interchange (EDI) Registration and Electronic Data Interchange (EDI) Enrollment... Electronic Data Interface (EDI) functions. The EDI Enrollment and the Medicare Registration Forms are... efficient uniform means by which Medicare captures information necessary to drive Medicare EDI security and...
International Nuclear Information System (INIS)
Velden, Joanne M. van der; Verkooijen, Helena M.; Seravalli, Enrica; Hes, Jochem; Gerlich, A. Sophie; Kasperts, Nicolien; Eppinga, Wietse S. C.; Verlaan, Jorrit-Jan; Vulpen, Marco van
2016-01-01
Controlled Trial design. This design addresses common difficulties associated with classic pragmatic randomized controlled trials, such as disappointment bias in patients allocated to the control arm, slow recruitment, and poor generalizability. The Netherlands Trials Register number NL49316.041.14. ClinicalTrials.gov registration number: NCT02364115. Date of trial registration February 1, 2015
Evaluation of registration methods on thoracic CT
DEFF Research Database (Denmark)
Murphy, K.; van Ginneken, B.; Reinhardt, J.
2011-01-01
method and the evaluation is independent, using the same criteria for all participants. All results are published on the EMPIRE10 website (http://empire10.isi.uu.nl). The challenge remains ongoing and open to new participants. Full results from 24 algorithms have been published at the time of writing......EMPIRE10 (Evaluation of Methods for Pulmonary Image REgistration 2010) is a public platform for fair and meaningful comparison of registration algorithms which are applied to a database of intra-patient thoracic CT image pairs. Evaluation of non-rigid registration techniques is a non trivial task....... This article details the organisation of the challenge, the data and evaluation methods and the outcome of the initial launch with 20 algorithms. The gain in knowledge and future work are discussed....
Systematic Evaluation of Promising Clinical Trials-Gene Silencing for the Treatment of Glioblastoma.
Karaarslan, Numan; Yilmaz, Ibrahim; Ozbek, Hanefi; Caliskan, Tezcan; Topuk, Savas; Sirin, Duygu Yasar; Ates, Ozkan
2018-04-06
The aim of this study was to systematically investigate the role of artificial small interfering RNA (siRNA) molecules in glioblastoma treatment and to give a detailed overview of the literature concerning studies performed in this field worldwide in the last 31 years. Articles about clinical trials conducted between December 1, 1949 and November 8, 2017, were identified from the Cochrane Collaboration, the Cochrane Library, Ovid MEDLINE, ProQuest, the National Library of Medicine, and PubMed electronic databases, using the terms "post transcriptional gene silencing," "small interfering RNA," "siRNA," and "glioblastoma," either individually or combined (\\"OR\\" and \\"AND"), without language and country restrictions. Articles that met the examination criteria were included in the study. After descriptive statistical evaluation, the results were reported in frequency (%). After scanning 2.752 articles, five articles were found that met the research criteria. Examination of full texts of the five identified articles provided no sufficient evidence for research conducted with regard to the use of gene silencing via siRNAs in glioblastoma treatment. To be able to evaluate the clinical use of siRNAs, there is an urgent need for in-vivo studies and for trials with randomized, controlled, and clinical designs that provide long-term functional outcomes.
Miyamoto, Gisela Cristiane; Franco, Katherinne Ferro Moura; van Dongen, Johanna M; Franco, Yuri Rafael Dos Santos; de Oliveira, Naiane Teixeira Bastos; Amaral, Diego Diulgeroglo Vicco; Branco, Amanda Nery Castelo; da Silva, Maria Liliane; van Tulder, Maurits W; Cabral, Cristina Maria Nunes
2018-01-01
OBJECTIVES: To evaluate the effectiveness and cost-utility of the addition of different doses of Pilates to an advice for non-specific chronic low back pain (NSCLBP) from a societal perspective. DESIGN: Randomised controlled trial with economic evaluation. SETTING: Physiotherapy clinic in São Paulo,
Juvenile offenders: competence to stand trial.
Soulier, Matthew
2012-12-01
This article details the legal background and assists the reader in the preparation and practical conduct of evaluations regarding juvenile adjudicative competency. The material is presented to be useful as a guide to direct questions of competency and covers aspects of evaluation that include: legal standard for competency to stand trial, developmental immaturity, current practice in juvenile competency to stand trial, forensic evaluation of juvenile competency to stand trial, organizing the evaluation, collateral sources of information, psychiatric evaluation of juvenile adjudicative competency, assessment of mental disorder and intellectual disability, assessment of developmental status, assessment of functional abilities for adjudicative competence, and reaching the forensic opinion. Copyright © 2012 Elsevier Inc. All rights reserved.
Directory of Open Access Journals (Sweden)
Alcacer-Pitarch Begonya
2012-02-01
Full Text Available Abstract Background Foot problems associated with Systemic Sclerosis (SSc/Scleroderma have been reported to be both common and disabling. There are only limited data describing specifically, the mechanical changes occurring in the foot in SSc. A pilot project conducted in preparation for this trial confirmed the previous reports of foot related impairment and reduced foot function in people with SSc and demonstrated a link to mechanical etiologies. To-date there have been no formal studies of interventions directed at the foot problems experienced by people with Systemic Sclerosis. The primary aim of this trial is to evaluate whether foot pain and foot-related health status in people with Systemic Sclerosis can be improved through the provision of a simple pressure-relieving insole. Methods The proposed trial is a pragmatic, multicenter, randomised controlled clinical trial following a completed pilot study. In four participating centres, 140 consenting patients with SSc and plantar foot pain will be randomised to receive either a commercially available pressure relieving and thermally insulating insole, or a sham insole with no cushioning or thermal properties. The primary end point is a reduction in pain measured using the Foot Function Index Pain subscale, 12 weeks after the start of intervention. Participants will complete the primary outcome measure (Foot Function Index pain sub-scale prior to randomisation and at 12 weeks post randomisation. Secondary outcomes include participant reported pain and disability as derived from the Manchester Foot Pain and Disability Questionnaire and plantar pressures with and without the insoles in situ. Discussion This trial protocol proposes a rigorous and potentially significant evaluation of a simple and readily provided therapeutic approach which, if effective, could be of a great benefit for this group of patients. Trial registration number ISRCTN: ISRCTN02824122
Gowensmith, W Neil; Murrie, Daniel C; Boccaccini, Marcus T
2012-04-01
Despite many studies that examine the reliability of competence to stand trial (CST) evaluations, few shed light on "field reliability," or agreement among forensic evaluators in routine practice. We reviewed 216 cases from Hawaii, which requires three separate evaluations from independent clinicians for each felony defendant referred for CST evaluation. Results revealed moderate agreement. In 71% of initial CST evaluations, all evaluators agreed about a defendant's competence or incompetence (kappa = .65). Agreement was somewhat lower (61%, kappa = .57) in re-evaluations of defendants who were originally found incompetent and sent for restoration services. We also examined the decisions judges made about a defendant's CST. When evaluators disagreed, judges tended to make decisions consistent with the majority opinion. But when judges disagreed with the majority opinion, they more often did so to find a defendant incompetent than competent, suggesting a generally conservative approach. Overall, results reveal moderate agreement among independent evaluators in routine practice. But we discuss the potential for standardized training and methodology to further improve the field reliability of CST evaluations.
International Nuclear Information System (INIS)
Sagawa, Motoyasu; Tanaka, Makoto; Mizukami, Satoru
2011-01-01
The objective of this study was to evaluate the efficacy of lung cancer screening by thoracic computed tomography (CT), a randomized controlled trial was planned in Japan. The randomized trial was designed as follows: participants were randomly assigned into 2 groups, CT group and XP group; XP group would receive 10 times of lung cancer screening by chest x-ray annually for 10 years; smokers in CT group would receive 10 times of lung cancer screening by thoracic CT annually for 10 years; non-smokers in CT group would receive 3 times of lung cancer screening by thoracic CT and 7 times of chest x-ray during 10 years. A pilot study was performed to evaluate the feasibility of the trial. A letter for recruitment to participate in the above trial was mailed to the citizens in Hakui City, who were 50-64 years old and underwent regular lung cancer screening using chest x-ray this year. In the letter we explained that the efficacy of lung cancer screening by thoracic CT had not been proved yet; only half of the participants could undergo thoracic CT screening; thoracic CT screening might cause unfavorable consequences like radiation exposure, false positives or overdiagnosis. Of 329 persons who received the letter of recruitment, 117 replied. After meeting with us for detailed explanation, 111 persons participated in the above randomized trial. The compliance of recruitment is high (approximately one third) and the above trial may be feasible. (author)
Förster, Matthias; Haaland, Stein
2015-04-01
Here, we present a study of ionospheric convection at high latitudes that is based on satellite measurements of the Electron Drift Instrument (EDI) on-board the Cluster satellites, which were obtained over a full solar cycle (2001-2013). The mapped drift measurements are covering both hemispheres and a variety of different solar wind and interplanetary magnetic field (IMF) conditions. The large amount of data allows us to perform more detailed statistical studies. We show that flow patterns and polar cap potentials can differ between the two hemispheres on statistical average for a given IMF orientation. In particular, during southward directed IMF conditions, and thus enhanced energy input from the solar wind, we find that the southern polar cap has a higher cross polar cap potential. We also find persistent north-south asymmetries which cannot be explained by external drivers alone. Much of these asymmetries can probably be explained by significant differences in the strength and configuration of the geomagnetic field between the Northern and Southern Hemisphere. Since the ionosphere is magnetically connected to the magnetosphere, this difference will also be reflected in the magnetosphere in the form of different feedback from the two hemispheres. Consequently, local ionospheric conditions and the geomagnetic field configuration are important for north-south asymmetries in large regions of geospace. The average convection is higher during periods with high solar activity. Although local ionospheric conditions may play a role, we mainly attribute this to higher geomagnetic activity due to enhanced solar wind - magnetosphere interactions.
48 CFR 552.216-72 - Placement of Orders.
2010-10-01
...] (b) Orders may be placed through Electronic Data Interchange (EDI) or mailed in paper form. EDI... Data Interchange (EDI) format. (c) If the Contractor agrees, General Services Administration's Federal Acquisition Service (FAS) will place all orders by EDI using computer-to-computer EDI. If computer-to-computer...
DEFF Research Database (Denmark)
Ruperto, Nicolino; Pistorio, Angela; Ravelli, Angelo
2010-01-01
To develop a provisional definition for the evaluation of response to therapy in juvenile dermatomyositis (DM) based on the Paediatric Rheumatology International Trials Organisation juvenile DM core set of variables....
Sundaresan, Puma; Ager, Brittany; Turner, Sandra; Costa, Dan; Kneebone, Andrew; Pearse, Maria; Woo, Henry; Tesson, Stephanie; Juraskova, Ilona; Butow, Phyllis
2017-10-01
Randomised controlled trials (RCTs) are considered the 'gold-standard' for evaluating medical treatments. However, patients and clinicians report difficulties with informed consent and recruitment. We evaluated the utility of a Decision Aid (DA) in reducing RCT-related decisional conflict, and improving RCT knowledge and recruitment. Potential participants for a radiotherapy RCT were invited to participate in the current study. Participants were randomised to receive the RCT's participant information sheet with or without a DA. Questionnaires were administered at baseline, one and six months. The primary outcome measure was decisional conflict. Secondary outcome measures included knowledge regarding and recruitment to the RCT. 129 men were randomised to the DA (63) and control (66) arms. Decisional conflict was significantly lower over 6-months (p=0.048) in the DA arm. Knowledge regarding the RCT was significantly higher at 6months (p=0.033) in the DA arm. 20.6% of the DA arm (13 of 63) and 9% of the control arm (6 of 66) entered the RCT. This study demonstrates the utility of a DA in reducing decisional conflict and improving trial knowledge in men with cancer who are making decisions regarding RCT participation. Crown Copyright © 2017. Published by Elsevier B.V. All rights reserved.
Comparability of prostate trials
DEFF Research Database (Denmark)
Suciu, S; Sylvester, R; Iversen, P
1993-01-01
The present overview of advanced prostate cancer required the identification of randomized clinical trials studying the question of maximal androgen blockade versus the classic castration therapy. The heterogeneity of the trials concerned the type of castration (surgical or chemical) and the type...... of antiandrogen (flutamide, Anandron, or cyproterone acetate) added to castration. This paper reviews the different types of heterogeneity that might exist among trials that are involved in the overview: study design, randomization procedure, treatment evaluation, statistical evaluation, and data maturity....... In order to overcome these various types of heterogeneity and to compare like with like, the treatment comparison should be stratified a posteriori by question (i.e., type of castration or type of anti-androgen studied) and by study. In this way, one may draw valid conclusions. Of course, those trials...
Adherence to placebo and mortality in the Beta Blocker Evaluation of Survival Trial (BEST).
Pressman, Alice; Avins, Andrew L; Neuhaus, John; Ackerson, Lynn; Rudd, Peter
2012-05-01
Randomized controlled trials have reported lower mortality among patients who adhere to placebo compared with those who do not. We explored this phenomenon by reanalyzing data from the placebo arm of the Beta Blocker Evaluation of Survival Trial (BEST), a randomized, double-blind, placebo-controlled trial of bucindolol and mortality. Our primary aim was to measure and explain the association between adherence to placebo and total mortality among the placebo-allocated participants in the BEST trial. Secondary aims included assessment of the association between placebo adherence and cause-specific mortality. Participants with "higher placebo adherence" were defined as having taken at least 75% of their placebo study medication over the entire course of each individual's participation in the study, while those with "lower placebo adherence" took <75%. Primary outcome was in-study all-cause mortality. To account for confounding, we adjusted for all available modifiable, non-modifiable and psychosocial variables. Adherent participants had a significantly lower total mortality compared to less-adherent participants (HR=0.61, 95% Confidence Interval: 0.46-0.82). Adjusting for available confounders did not change the magnitude or significance of the estimates. When considering cause-specific mortality, CVD and pump failure showed similar associations. Analyses of the BEST trial data support a strong association between adherence to placebo study medication and total mortality. While probably not due to publication bias or simple confounding by healthy lifestyle factors, the underlying explanation for the association remains a mystery. Prospective examination of this association is necessary to better understand the underlying mechanism of this observation. Copyright © 2012 Elsevier Inc. All rights reserved.
Verschoore, M; Poncet, M; Schaefer, H; Revuz, J; De Prost, Y; Guillaume, J C; Ortonne, J P; Czernielewski, J
1991-01-01
Acne is a frequent dermatologic disease of the teenagers. Methodology of antiacne preparations clinical trials has evolved recently, leading to better comprehension of acne treatment on acne lesions. The main rules for good clinical evaluation of acne treatments are: an objective counting of each individual lesions on a defined area (face, back), a global acne assessment, a therapy duration from 1 to 3 months or more, a skin safety evaluation for erythema, desquamation, dryness, itching, burning and oiliness with a 0 to 3 scoring system.
Directory of Open Access Journals (Sweden)
Alice Bruscolini
2018-01-01
Full Text Available Purpose. To investigate the role of choroidal thickness evaluation with spectral domain optical coherence tomography (SDOCT and enhanced depth imaging (EDI technique in the management of patients with Graves’ disease and orbitopathy (GO. Methods. Thirty-six eyes of 18 patients with GO and 36 eyes of 18 age-matched control subjects were included in this retrospective observational study. All the subjects underwent a complete ophthalmological evaluation, including clinical activity score (CAS and exophthalmometry. The SDOCT images of the choroid were obtained by EDI modality. Results. Choroidal thickness was significantly increased in GO than in control eyes (p<0.01. A significant correlation was found between choroidal thickness and CAS, proptosis, and the duration of disease (p<0.05. Conclusion. This study shows that choroidal thickness, evaluated with EDI-OCT, is significantly increased in patients with GO and correlates with the activity of the disease, proptosis, and duration of the disease. The choroidal thickening may reflect the ocular hemodynamic changes, and enhanced depth imaging optical coherence tomography may be a useful tool for the evaluation of orbital congestion and management of patients with Graves’ disease and orbital involvement.
Antibacterial evaluation of Anacardium occidentale (Linn ...
African Journals Online (AJOL)
aghomotsegin
Química Nova. 30(2):374-381. Gonçalves GMS, Gobbo J (2012). Antimicrobial Effect of Anacardium. Occidentale Extract and Cosmetic Formulation Development. Braz. Arc. Biol. Technol. 55(6): 843-850. Matos FJA (1997). Introdução à fitoquímica experimental. UFC Edições. pp. 44-46. Melo AFM, Santos EJV, Souza LFC, ...
2010-07-15
...) will place all orders by EDI using computer-to-computer EDI. If computer-to-computer EDI is not possible, FAS will use an alternative EDI method allowing the Contractor to receive orders by facsimile transmission. Subject to the Contractor's agreement, other agencies may place orders by EDI. * * * * * (g) The...
Karyotaki, E; Tordrup, D; Buntrock, C; Bertollini, R; Cuijpers, P
2017-10-01
The aim of this systematic review of economic evaluations alongside randomised controlled trials (RCTs) was to provide a comprehensive overview of the evidence concerning cost-effectiveness analyses of common treatment options for major depression. An existing database was used to identify studies reporting cost-effectiveness results from RCTs. This database has been developed by a systematic literature search in the bibliographic databases of PubMed, PsychINFO, Embase and Cochrane library from database inception to December 2014. We evaluated the quality of economic evaluations using a 10-item short version of the Drummond checklist. Results were synthesised narratively. The risk of bias of the included RCTs was assessed, based on the Cochrane risk of bias assessment tool. Fourteen RCTs were included from the 5580 articles screened on titles and abstracts. The methodological quality of the health economic evaluations was relatively high and the majority of the included RCTs had low risk of bias in most of Cochrane items except blinding of participants and personnel. Cognitive behavioural therapy was examined in seven trials as part of a variety of treatment protocols and seems cost-effective compared with pharmacotherapy in the long-term. However cost-effectiveness results for the combination of psychotherapy with pharmacotherapy are conflicting and should be interpreted with caution due to limited comparability between the examined trials. For several treatments, only a single economic evaluation was reported as part of a clinical trial. This was the case for comparisons between different classes of antidepressants, for several types of psychotherapy (behavioural activation, occupational therapy, interpersonal psychotherapy, short-term psychotherapy, psychodynamic psychotherapy, rational emotive behavioural therapy, solution focused therapy), and for transcranial magnetic stimulation v. electroconvulsive therapy. The limited evidence base for these interventions
Directory of Open Access Journals (Sweden)
Ramesh Raj Puri
2015-06-01
Full Text Available Around 25% of total wheat area in Terai of Nepal falls under rain-fed and partially irrigated condition. A Coordinated varietal trial (CVT was conducted during two consecutive crop cycles (2011-12 and 2012-13 under timely sown rain-fed conditions of Terai. The trial was conducted in Alpha Lattice design with two replications at Nepal Agricultural Research Council, National Wheat Research Program, Bhairahawa and Nepal Agricultural Research Council, Regional Agriculture Research Station, Nepalgunj. Observations were recorded for yield and yield traits and analyzed using statistical software Cropstat 7.2.The combined analysis of coordinated varietal trial showed that BL 3978 possessed the highest yield (2469.2 Kg ha-1 followed by NL 1097 (2373.2 Kg ha-1 and NL 1094 (2334.06 Kg ha-1. Genotype x Environment interaction for grain yield was significant (p<0.05 over locations and years. BL 3978 with early maturity (111 days escaped the heat stress environment. Among the top three genotypes, BL 3978 was consistently higher in both favorable and unfavorable conditions. Earliness was one of the major traits for heat tolerant genotypes. The three identified genotypes will be further evaluated in participatory varietal selection or coordinated farmers field trial followed by small plot seed multiplication (seed increase and release in the future for timely sown rain-fed conditions. These lines also appear suitable for inclusion in crossing program targeted for water stress tolerance variety development. DOI: http://dx.doi.org/10.3126/ije.v4i2.12649 International Journal of Environment Vol.4(2 2015: 289-295
Stice, Eric; Rohde, Paul; Seeley, John R.; Gau, Jeff M.
2010-01-01
Objective: Evaluate a new 5-step method for testing mediators hypothesized to account for the effects of depression prevention programs. Method: In this indicated prevention trial, at-risk teens with elevated depressive symptoms were randomized to a group cognitive-behavioral (CB) intervention, group supportive expressive intervention, CB…
de Ridder, Inger R; den Hertog, Heleen M; van Gemert, H Maarten A; Schreuder, A H C M L Tobien; Ruitenberg, Annemieke; Maasland, E Lisette; Saxena, Ritu; van Tuijl, Jordie H; Jansen, Ben P W; Van den Berg-Vos, Renske M; Vermeij, Frederique; Koudstaal, Peter J; Kappelle, L Jaap; Algra, Ale; van der Worp, H Bart; Dippel, Diederik W J
2017-04-01
Subfebrile body temperature and fever in the first days after stroke are strongly associated with unfavorable outcome. A subgroup analysis of a previous trial suggested that early treatment with paracetamol may improve functional outcome in patients with acute stroke and a body temperature of ≥36.5°C. In the present trial, we aimed to confirm this finding. PAIS 2 (Paracetamol [Acetaminophen] in Stroke 2) was a multicenter, randomized, double-blind, placebo-controlled clinical trial. We aimed to include 1500 patients with acute ischemic stroke or intracerebral hemorrhage within 12 hours of symptom onset. Patients were treated with paracetamol in a daily dose of 6 g or matching placebo for 3 consecutive days. The primary outcome was functional outcome at 3 months, assessed with the modified Rankin Scale and analyzed with multivariable ordinal logistic regression. Because of slow recruitment and lack of funding, the study was stopped prematurely. Between December 2011 and October 2015, we included 256 patients, of whom 136 (53%) were allocated to paracetamol. In this small sample, paracetamol had no effect on functional outcome (adjusted common odds ratio, 1.15; 95% confidence interval, 0.74-1.79). There was no difference in the number of serious adverse events (paracetamol n=35 [26%] versus placebo n=28 [24%]). Treatment with high-dose paracetamol seemed to be safe. The effect of high-dose paracetamol on functional outcome remains uncertain. Therefore, a large trial of early treatment with high-dose paracetamol is still needed. URL: http://www.trialregister.nl. Unique identifier: NTR2365. © 2017 American Heart Association, Inc.
Directory of Open Access Journals (Sweden)
Kampik A
2012-11-01
Full Text Available Lukas Reznicek, Efstathios Vounotrypidis, Florian Seidensticker, Karsten Kortuem, Anselm Kampik, Aljoscha S Neubauer, Armin WolfDepartment of Ophthalmology, Ludwig Maximilians University Muenchen, Munich, GermanyBackground: This study’s objective was to optimize the visualization of three different spectral-domain optical coherence tomography (SD-OCT display modalities and evaluate enhanced depth imaging (EDI by comparing the maximum depth of assessment in conventional versus inverted cross-sectional OCT images in healthy subjects and in patients with retinal pigment epithelial detachment (PED.Methods: Cross-sectional SD-OCT conventional and inverted images were obtained with the HRA2 (Heidelberg Retina Angiograph II, Heidelberg Engineering, Heidelberg, Germany. Horizontal as well as vertical sections in three different display modes were blinded for evaluation by three independent, experienced graders for maximal imaging depth of the deep ocular fundus layers.Results: The mean imaging depth as measured from the inner segment/outer segment (IS/OS to the outer choroid of all 14 healthy subjects was 197 ± 44 µm vs 263 ± 56 µm for conventional vs EDI scans: in black/white mode, it was significantly lower (P < 0.001 than in white/black mode (249 ± 42 µm vs 337 ± 71 µm and color/heat mode (254 ± 48 µm vs 354 ± 73 µm. The mean imaging depth of all 14 study eyes with PED was 240 ± 78 µm vs 345 ± 100 µm for conventional vs EDI scans in black/white mode, and was significantly lower (P < 0.001 than in white/black mode (393 ± 104 µm vs 464 ± 126 µm and in color/heat mode (373 ± 106 µm vs 453 ± 114 µm. In each display modality of healthy subjects and of patients with PED, EDI scans showed a significantly higher imaging depth than the corresponding conventional scans.Conclusion: White/black and color/heat modes allow increased imaging depth, compared to black/white mode using both conventional or EDI OCT scans in healthy subjects or
Demand and withdraw behaviors in couples with a history of infidelity.
Balderrama-Durbin, Christina M; Allen, Elizabeth S; Rhoades, Galena K
2012-02-01
Although relationship distress and dissolution are common consequences of sexual involvement outside a committed relationship, there is little empirical information regarding communication behaviors of couples who have experienced extradyadic involvement (EDI). This study examined male and female demand and withdraw behaviors in videotaped conflict discussions among 170 married or seriously dating couples categorized into 3 groups: those without a history of sexual EDI, those with a history of sexual EDI that was known to the other partner, and those with a history of "unknown" (undisclosed or undiscovered) sexual EDI. Both men and women in a relationship where there was at least one unknown EDI demonstrated the highest levels of demand behaviors. Furthermore, demand behaviors were higher for participating partners (those engaging in an outside sexual relationship) in relationships with an unknown EDI compared with participating partners in relationships with a known EDI. Conversely, demand behaviors were higher among nonparticipating partners in relationships with known EDI, compared to with nonparticipating partners in relationships with unknown EDI. Withdraw behaviors demonstrated a less pronounced and less consistent pattern of elevation by EDI group, and role within EDI, compared with demand behaviors. Clinical and relational implications for these findings are discussed.
Singh, Preet Mohinder; Borle, Anuradha; Makkar, Jeetinder Kaur; Trisha, Aanjan; Sinha, Aashish
2018-01-01
Patients undergoing renal transplant (RT) have altered drug/opioid pharmacokinetics. Transversus abdominis plane (TAP) block in renal transplant recipients has been recently evaluated for analgesic and opioid-sparing potential by many trials. The studies comparing TAP-block to conventional analgesic regimens for RT were searched. Comparisons were made for total opioids consumed (as morphine-equivalents) during the first postoperative 24-h (primary objective), intraoperative, and immediate-postoperative period. Pain scores and postoperative nausea-vomiting (PONV) were also evaluated. Trial sequential analysis (TSA) was used to quantify the strength of analysis. Ten-trials with 258 and 237 patients in control and TAP-block group, respectively, were included. TAP-block decreased the 24-h (reported in 9-trials) opioid consumption by 14.61 ± 4.34 mg (reduction by 42.7%, random-effects, P consumption also decreased by 2.06 ± 0.63 mg (reduction of 27.8%) (random effects, P consumption in RT recipients. Persistent and better pain control is achieved when TAP-Block is used. Benefits of TAP block extend beyond the analgesic actions alone as it also decreases the 24-h incidence of postoperative nausea vomiting as well. The technique of the block needs standardization for RT recipients.
Achana, Felix; Petrou, Stavros; Khan, Kamran; Gaye, Amadou; Modi, Neena
2018-01-01
A new methodological framework for assessing agreement between cost-effectiveness endpoints generated using alternative sources of data on treatment costs and effects for trial-based economic evaluations is proposed. The framework can be used to validate cost-effectiveness endpoints generated from routine data sources when comparable data is available directly from trial case report forms or from another source. We illustrate application of the framework using data from a recent trial-based economic evaluation of the probiotic Bifidobacterium breve strain BBG administered to babies less than 31 weeks of gestation. Cost-effectiveness endpoints are compared using two sources of information; trial case report forms and data extracted from the National Neonatal Research Database (NNRD), a clinical database created through collaborative efforts of UK neonatal services. Focusing on mean incremental net benefits at £30,000 per episode of sepsis averted, the study revealed no evidence of discrepancy between the data sources (two-sided p values >0.4), low probability estimates of miscoverage (ranging from 0.039 to 0.060) and concordance correlation coefficients greater than 0.86. We conclude that the NNRD could potentially serve as a reliable source of data for future trial-based economic evaluations of neonatal interventions. We also discuss the potential implications of increasing opportunity to utilize routinely available data for the conduct of trial-based economic evaluations.
Korthals-de Bos, Ingeborg B. C.; Hoving, Jan L.; van Tulder, Maurits W.; Rutten-van Mölken, Maureen P. M. H.; Adèr, Herman J.; de Vet, Henrica C. W.; Koes, Bart W.; Vondeling, Hindrik; Bouter, Lex M.
2003-01-01
OBJECTIVE: To evaluate the cost effectiveness of physiotherapy, manual therapy, and care by a general practitioner for patients with neck pain. DESIGN: Economic evaluation alongside a randomised controlled trial. SETTING: Primary care. PARTICIPANTS: 183 patients with neck pain for at least two weeks
Sullivan, Meghan O; Gordon-Evans, Wanda J; Knap, Kim E; Evans, Richard B
2013-04-01
To evaluate the efficacy of pulsed signal therapy (PST) in reducing pain and increasing function in dogs with osteoarthritis (OA) using a randomized, blinded, controlled clinical trial. Randomized, controlled, blinded clinical trial. Adult dogs (n = 60) with moderate-to-severe clinical signs of OA. Dogs were randomized by age into 2 groups: dogs ≥ 9 years and dogs Goniometry and gait analysis were performed, and the Canine Brief Pain Inventory (CBPI) questionnaire was given to the owners to fill out without supervision. Outcome measures were repeated at the end of treatment (Day 11) and 6 weeks after beginning treatment (Day 42). The PST group performed significantly better than the control group as measured by the CBPI Severity and Interference scores (P Veterinary Surgeons.
Strategies to improve retention in randomised trials
Brueton, Valerie C; Tierney, Jayne; Stenning, Sally; Harding, Seeromanie; Meredith, Sarah; Nazareth, Irwin; Rait, Greta
2013-01-01
Background Loss to follow-up from randomised trials can introduce bias and reduce study power, affecting the generalisability, validity and reliability of results. Many strategies are used to reduce loss to follow-up and improve retention but few have been formally evaluated. Objectives To quantify the effect of strategies to improve retention on the proportion of participants retained in randomised trials and to investigate if the effect varied by trial strategy and trial setting. Search methods We searched the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, PreMEDLINE, EMBASE, PsycINFO, DARE, CINAHL, Campbell Collaboration's Social, Psychological, Educational and Criminological Trials Register, and ERIC. We handsearched conference proceedings and publication reference lists for eligible retention trials. We also surveyed all UK Clinical Trials Units to identify further studies. Selection criteria We included eligible retention trials of randomised or quasi-randomised evaluations of strategies to increase retention that were embedded in 'host' randomised trials from all disease areas and healthcare settings. We excluded studies aiming to increase treatment compliance. Data collection and analysis We contacted authors to supplement or confirm data that we had extracted. For retention trials, we recorded data on the method of randomisation, type of strategy evaluated, comparator, primary outcome, planned sample size, numbers randomised and numbers retained. We used risk ratios (RR) to evaluate the effectiveness of the addition of strategies to improve retention. We assessed heterogeneity between trials using the Chi2 and I2 statistics. For main trials that hosted retention trials, we extracted data on disease area, intervention, population, healthcare setting, sequence generation and allocation concealment. Main results We identified 38 eligible retention trials. Included trials evaluated six broad types of strategies to improve retention. These
'Healthy Eating and Lifestyle in Pregnancy (HELP)' trial: Process evaluation framework.
Simpson, Sharon A; Cassidy, Dunla; John, Elinor
2014-07-01
We developed and tested in a cluster RCT a theory-driven group-based intervention for obese pregnant women. It was designed to support women to moderate weight gain during pregnancy and reduce BMI one year after birth, in addition to targeting secondary health and wellbeing outcomes. In line with MRC guidance on developing and evaluating complex interventions in health, we conducted a process evaluation alongside the trial. This paper describes the development of the process evaluation framework. This cluster RCT recruited 598 pregnant women. Women in the intervention group were invited to attend a weekly weight-management group. Following a review of relevant literature, we developed a process evaluation framework which outlined key process indicators that we wanted to address and how we would measure these. Central to the process evaluation was to understand the mechanism of effect of the intervention. We utilised a logic-modelling approach to describe the intervention which helped us focus on what potential mediators of intervention effect to measure, and how. The resulting process evaluation framework was designed to address 9 core elements; context, reach, exposure, recruitment, fidelity, recruitment, retention, contamination and theory-testing. These were assessed using a variety of qualitative and quantitative approaches. The logic model explained the processes by which intervention components bring about change in target outcomes through various mediators and theoretical pathways including self-efficacy, social support, self-regulation and motivation. Process evaluation is a key element in assessing the effect of any RCT. We developed a process evaluation framework and logic model, and the results of analyses using these will offer insights into why the intervention is or is not effective. Copyright © 2014.
Karlsen, Kari Ebbesen; Vrabel, Karianne; Bratland-Sanda, Solfrid; Ulleberg, Pål; Benum, Kirsten
2018-01-01
The aim of this study is to examine the effect of yoga treatment of eating disorders (EDs). Adult females meeting the Diagnostic and Statistical Manual-IV criteria for bulimia nervosa or ED not otherwise specified ( n = 30) were randomized to 11-week yoga intervention group (2 × 90 min/week) or a control group. Outcome measures, the Eating Disorder Examination (EDE)-Interview and Eating Disorders Inventory-2 (EDI-2) scores, were administered at baseline, posttest, and at 6-month follow-up. There was a dropout rate of 30% (posttest) and 37% (6-month follow-up). The intervention group showed reductions in EDE global score ( P control group. The differences between the groups increased at 6-month follow-up. There were no differences between the groups in the EDI-2 score. The results indicate that yoga could be effective in the treatment of ED.
Directory of Open Access Journals (Sweden)
van der Wilt Gert-Jan
2011-08-01
Full Text Available Abstract Background Shared medical appointments are a series of one-to-one doctor-patient contacts, in presence of a group of 6-10 fellow patients. This group visits substitute the annual control visits of patients with the neurologist. The same items attended to in a one-to- one appointment are addressed. The possible advantages of a shared medical appointment could be an added value to the present management of neuromuscular patients. The currently problem-focused one-to-one out-patient visits often leave little time for the patient's psychosocial needs, patient education, and patient empowerment. Methods/design A randomized, prospective controlled study (RCT with a follow up of 6 months will be conducted to evaluate the clinical and cost-effectiveness of shared medical appointments compared to usual care for 300 neuromuscular patients and their partners at the Radboud University Nijmegen Medical Center. Every included patient will be randomly allocated to one of the two study arms. This study has been reviewed and approved by the medical ethics committee of the region Arnhem-Nijmegen, the Netherlands. The primary outcome measure is quality of life as measured by the EQ-5D, SF-36 and the Individualized neuromuscular Quality of Life Questionnaire. The primary analysis will be an intention-to-treat analysis on the area under the curve of the quality of life scores. A linear mixed model will be used with random factor group and fixed factors treatment, baseline score and type of neuromuscular disease. For the economic evaluation an incremental cost-effectiveness analysis will be conducted from a societal perspective, relating differences in costs to difference in health outcome. Results are expected in 2012. Discussion This study will be the first randomized controlled trial which evaluates the effect of shared medical appointments versus usual care for neuromuscular patients. This will enable to determine if there is additional value of shared
Poston, Lucilla; Briley, Annette L; Barr, Suzanne; Bell, Ruth; Croker, Helen; Coxon, Kirstie; Essex, Holly N; Hunt, Claire; Hayes, Louise; Howard, Louise M; Khazaezadeh, Nina; Kinnunen, Tarja; Nelson, Scott M; Oteng-Ntim, Eugene; Robson, Stephen C; Sattar, Naveed; Seed, Paul T; Wardle, Jane; Sanders, Thomas A B; Sandall, Jane
2013-07-15
Complex interventions in obese pregnant women should be theoretically based, feasible and shown to demonstrate anticipated behavioural change prior to inception of large randomised controlled trials (RCTs). The aim was to determine if a) a complex intervention in obese pregnant women leads to anticipated changes in diet and physical activity behaviours, and b) to refine the intervention protocol through process evaluation of intervention fidelity. We undertook a pilot RCT of a complex intervention in obese pregnant women, comparing routine antenatal care with an intervention to reduce dietary glycaemic load and saturated fat intake, and increase physical activity. Subjects included 183 obese pregnant women (mean BMI 36.3 kg/m2). Compared to women in the control arm, women in the intervention arm had a significant reduction in dietary glycaemic load (33 points, 95% CI -47 to -20), (p change. Physical discomfort and sustained barriers to physical activity were common at 28 weeks' gestation. Process evaluation identified barriers to recruitment, group attendance and compliance, leading to modification of intervention delivery. This pilot trial of a complex intervention in obese pregnant women suggests greater potential for change in dietary intake than for change in physical activity, and through process evaluation illustrates the considerable advantage of performing an exploratory trial of a complex intervention in obese pregnant women before undertaking a large RCT. ISRCTN89971375.
HowNutsAreTheDutch (HoeGekIsNL): A crowdsourcing study of mental symptoms and strengths.
Krieke, Lian Van Der; Jeronimus, Bertus F; Blaauw, Frank J; Wanders, Rob B K; Emerencia, Ando C; Schenk, Hendrika M; Vos, Stijn De; Snippe, Evelien; Wichers, Marieke; Wigman, Johanna T W; Bos, Elisabeth H; Wardenaar, Klaas J; Jonge, Peter De
2016-06-01
HowNutsAreTheDutch (Dutch: HoeGekIsNL) is a national crowdsourcing study designed to investigate multiple continuous mental health dimensions in a sample from the general population (n = 12,503). Its main objective is to create an empirically based representation of mental strengths and vulnerabilities, accounting for (i) dimensionality and heterogeneity, (ii) interactivity between symptoms and strengths, and (iii) intra-individual variability. To do so, HowNutsAreTheDutch (HND) makes use of an internet platform that allows participants to (a) compare themselves to other participants via cross-sectional questionnaires and (b) to monitor themselves three times a day for 30 days with an intensive longitudinal diary study via their smartphone. These data enable for personalized feedback to participants, a study of profiles of mental strengths and weaknesses, and zooming into the fine-grained level of dynamic relationships between variables over time. Measuring both psychiatric symptomatology and mental strengths and resources enables for an investigation of their interactions, which may underlie the wide variety of observed mental states in the population. The present paper describes the applied methods and technology, and presents the sample characteristics. Copyright © 2015 John Wiley & Sons, Ltd. Copyright © 2015 John Wiley & Sons, Ltd.
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van Rens Ger HMB
2010-03-01
Full Text Available Abstract Background Reading problems are frequently reported by visually impaired persons. A closed-circuit television (CCTV can be helpful to maintain reading ability, however, it is difficult to learn how to use this device. In the Netherlands, an evidence-based rehabilitation program in the use of CCTVs was lacking. Therefore, a standard training protocol needed to be developed and tested in a randomized controlled trial (RCT to provide an evidence-based training program in the use of this device. Methods/Design To develop a standard training program, information was collected by studying literature, observing training in the use of CCTVs, discussing the content of the training program with professionals and organizing focus and discussion groups. The effectiveness of the program was evaluated in an RCT, to obtain an evidence-based training program. Dutch patients (n = 122 were randomized into a treatment group: normal instructions from the supplier combined with training in the use of CCTVs, or into a control group: instructions from the supplier only. The effect of the training program was evaluated in terms of: change in reading ability (reading speed and reading comprehension, patients' skills to operate the CCTV, perceived (vision-related quality of life and tasks performed in daily living. Discussion The development of the CCTV training protocol and the design of the RCT in the present study may serve as an example to obtain an evidence-based training program. The training program was adjusted to the needs and learning abilities of individual patients, however, for scientific reasons it might have been preferable to standardize the protocol further, in order to gain more comparable results. Trial registration http://www.trialregister.nl, identifier: NTR1031
Parker, George F
2014-01-01
Sovereign citizens hold a variety of beliefs that challenge the legitimacy of the United States government and criminal justice system. In criminal cases, sovereign citizens typically raise a variety of seemingly strange objections to the proceedings that can cause court participants to believe the defendant is not competent to stand trial. The author's case files were reviewed to identify all defendants who espoused sovereign citizen beliefs during a court-ordered competence-to-stand-trial evaluation. This case series consisted of nine evaluations completed between 2003 and 2012. A review of the outcomes in these cases showed that sovereign citizens typically have the capacity to understand criminal proceedings and assist an attorney. © 2014 American Academy of Psychiatry and the Law.
Directory of Open Access Journals (Sweden)
Fernanda Aiex Boni
2011-08-01
Full Text Available This study investigates some changes on image edition due to the transfer of Analogic to Digital Television in Brazil. Beginning with Vilém Flusser’s Media Theory and its concept of “apparatus”, it develops a theoretical analysis of the new relationship between journalists and digital editing instruments, taking into account the concept of hyperreality proposed by Jean Baudrillard. Retrieving the philosophical discourse of “real” throughout History and also the positivist concepts, base of the journalistic activity, it discusses how digital image manipulation and the construction of graphic universes meddle with the new representation of real presented by television news casting. From interviews with Rede Globo editors in São Paulo, Rio de Janeiro and Curitiba (cities where digital television has already been implemented, it analyses how this new technology can hinder the main commitment of journalism, which is reporting facts as faithfully as possible. The discussion proposes an engagement of professionals and society regarding digital images in the search of greater critical conscience towards digital images in news casting, with an ethic view of the use of manipulation resources and scene construction on news editing. Este trabalho investiga algumas mudanças na edição de imagens com a passagem da TV Analógica para a Digital no Brasil. A partir da teoria da mídia de Vilém Flusser e seu conceito de “aparelho” desenvolve-se uma análise teórica da nova relação entre os jornalistas e os equipamentos digitais de edição, levando-se em conta o conceito de hiper-realidade, proposto por Jean Baudrillard. Retomando o percurso filosófico do real ao longo da história e ainda os conceitos positivistas, que embasam a atividade jornalística, discute-se de que maneira a manipulação das imagens digitais e a construção deuniversos gráficos interferem na nova representação do real apresentada pelo telejornalismo. Com base em
2012-01-01
Background Blood pressure is considered to be a leading example of a valid surrogate endpoint. The aims of this study were to (i) formally evaluate systolic and diastolic blood pressure reduction as a surrogate endpoint for stroke prevention and (ii) determine what blood pressure reduction would predict a stroke benefit. Methods We identified randomised trials of at least six months duration comparing any pharmacologic anti-hypertensive treatment to placebo or no treatment, and reporting baseline blood pressure, on-trial blood pressure, and fatal and non-fatal stroke. Trials with fewer than five strokes in at least one arm were excluded. Errors-in-variables weighted least squares regression modelled the reduction in stroke as a function of systolic blood pressure reduction and diastolic blood pressure reduction respectively. The lower 95% prediction band was used to determine the minimum systolic blood pressure and diastolic blood pressure difference, the surrogate threshold effect (STE), below which there would be no predicted stroke benefit. The STE was used to generate the surrogate threshold effect proportion (STEP), a surrogacy metric, which with the R-squared trial-level association was used to evaluate blood pressure as a surrogate endpoint for stroke using the Biomarker-Surrogacy Evaluation Schema (BSES3). Results In 18 qualifying trials representing all pharmacologic drug classes of antihypertensives, assuming a reliability coefficient of 0.9, the surrogate threshold effect for a stroke benefit was 7.1 mmHg for systolic blood pressure and 2.4 mmHg for diastolic blood pressure. The trial-level association was 0.41 and 0.64 and the STEP was 66% and 78% for systolic and diastolic blood pressure respectively. The STE and STEP were more robust to measurement error in the independent variable than R-squared trial-level associations. Using the BSES3, assuming a reliability coefficient of 0.9, systolic blood pressure was a B + grade and diastolic blood pressure
McNulty, Cliodna; Ricketts, Ellie J; Rugman, Claire; Hogan, Angela; Charlett, Andre; Campbell, Rona
2015-11-17
Traditional randomised controlled trials evaluating the effect of educational interventions in general practice may produce biased results as participants know they are being evaluated. We aimed to explore the acceptability of a McNulty-Zelen Cluster Randomised Control Trial (CRT) design which conceals from educational participants that they are in a RCT. Consent is obtained from a trusted third party considered appropriate to give consent on participants' behalf, intervention practice staff then choose whether to attend the offered education as would occur with normal continuing professional development. We undertook semi structured telephone interviews in England with 16 general practice (GP) staff involved in a RCT evaluating an educational intervention aimed at increasing chlamydia screening tests in general practice using the McNulty-Zelen design, 4 Primary Care (PC) Research Network officers, 5 Primary Care Trust leads in Public or sexual health, and one Research Ethics committee Chair. Interviews were undertaken by members of the original intervention evaluation McNulty-Zelen design RCT study team. These experienced qualitative interviewers used an agreed semi-structured interview schedule and were careful not to lead the participants. To further mitigate against bias, the data analysis was undertaken by a researcher (CR) not involved in the original RCT. We reached data saturation and found five main themes; Support for the design: All found the McNulty-Zelen design acceptable because they considered that it generated more reliable evidence of the value of new educational interventions in real life GP settings. Lack of familiarity with study design: The design was novel to all. GP staff likened the evaluation using the McNulty-Zelen design to audit of their activities with feedback, which were to them a daily experience and therefore acceptable. Ethical considerations: Research stakeholders considered the consent procedure should be very clear and that
Craane, B.; Dijkstra, P. U.; Stappaerts, K.; De Laat, A.
Physical therapy is widely used to decrease pain and restore function in patients suffering from masticatory muscle pain. Controlled studies on its efficacy are scarce. This study evaluated the 1-year effect of a 6-week physical therapy programme in a single blind, randomized, controlled trial.
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Weijs Peter JM
2008-12-01
Full Text Available Abstract Background In the Netherlands, the first adolescents with diabetes mellitus type 2 as a result of obesity have recently been diagnosed. Therefore, it is very important that programs aiming at the prevention of type 2 diabetes of obese adolescents are developed and evaluated. Methods Go4it is a multidisciplinary group treatment that focuses on: 1 increasing awareness of the current dietary and physical activity behaviour (i.e. energy balance behaviour, 2 improving diet, 3 decreasing sedentary behaviour, 4 increasing levels of physical activity, and 5 coping with difficult situations. Go4it consists of 7 sessions with an interval of 2–3 weeks. The effectiveness of the multidisciplinary group treatment compared with usual care (i.e. referral to a dietician was evaluated in a randomised controlled trial. We examined effects on BMI(sds, body composition, energy expenditure, glucose tolerance and insulin resistance (primary outcome measure, as well as dietary and physical activity behaviour and quality of life. An economic evaluation from a societal perspective was conducted alongside the randomised trial to evaluate the cost-effectiveness of the multidisciplinary treatment program vs. usual care. Discussion In this paper we described a multidisciplinary treatment program (Go4it for obese adolescents and the design of a randomised controlled trial and economic evaluation to evaluate its effectiveness and cost-effectiveness. Trial registration Netherlands Trial Register (ISRCTN27626398.
Directory of Open Access Journals (Sweden)
Qi Xu
Full Text Available Live attenuated influenza vaccine (LAIV candidates of the H7 subtype, A/Netherlands/219/03 (H7N7, NL03 ca and A/chicken/British Columbia/CN-6/2004 (H7N3, BC04 ca, were evaluated for their receptor binding specificity and immunogenicity in ferrets. The BC04 ca virus exhibited α2,3-SA and α2,6-SA dual receptor binding preference while the NL03 ca virus preferentially bound to α2,3-SA. Substitution of the Q226 and G228 (Q-G by the L226 and S228 (L-S residues in the HA improved binding to α2,6-SA for NL03 ca. The vaccine viruses with L-S retained the attenuation phenotype. NL03 L-S ca replicated more efficiently than the original NL03 ca virus in the upper respiratory tract of ferrets, and induced higher levels of humoral and cellular immune responses. Prior vaccination with seasonal LAIV reduced H7-specific antibody responses, but did not reduce the H7N7 vaccine mediated protection against a heterologous H7N3 BC04 wt virus infection in ferrets. In addition, the H7N3 and H7N7 vaccine immunized ferret sera cross reacted with the newly emerged H7N9 virus. These data, in combination with the safety data from previously conducted Phase 1 studies, suggest that these vaccines may have a role in responding to the threat posed by the H7N9 virus.
Area Handbook Series: Argentina: A Country Study
1985-08-01
votes after a campaign that emphasized firm opposition to the military government and verbal attacks on the trade union leadership of the PJ...legal pro- cedures that were designed especially for these cases. The trials were open to the public, evidence would be taken verbal - ly instead of...1981,144-45. Terrera, Guillermo Alfredo. Geopolitica Argentina: Poblacion, fronteras, comunicaciones , antropologia. Buenos Aires: Edi- torial Plus
van Lettow, Britt; de Vries, Hein; Burdorf, Alex; Boon, Brigitte; van Empelen, Pepijn
2015-02-04
Excessive alcohol use is a prevalent and worldwide problem. Excessive drinking causes a significant burden of disease and is associated with both morbidity and excess mortality. Prototype alteration and provision of a cue reminder could be useful strategies to enhance the effectiveness of online tailored interventions for excessive drinking. Through a Web-based randomized controlled trial, 2 strategies (ie, prototype alteration and cue reminders) within an existing online personalized feedback intervention (Drinktest) aimed to reduce adults' excessive drinking. It was expected that both strategies would add to Drinktest and would result in reductions in alcohol consumption by intrinsic motivation and the seizure of opportunities to act. Participants were recruited online and through printed materials. Excessive drinking adults (N=2634) were randomly assigned to 4 conditions: original Drinktest, Drinktest plus prototype alteration, Drinktest plus cue reminder, and Drinktest plus prototype alteration and cue reminder. Evaluation took place at 1-month posttest and 6-month follow-up. Differences in drinking behavior, intentions, and behavioral willingness (ie, primary outcomes) were assessed by means of longitudinal multilevel analyses using a last observation carried forward method. Measures were based on self-reports. All conditions showed reductions in drinking behavior and willingness to drink, and increased intentions to reduce drinking. Prototype alteration (B=-0.15, Pprototypes. Thus, prototype alteration and cue reminder usage may be feasible and simple intervention strategies to promote reductions in alcohol consumption among adults, with an effect up to 6 months. Nederlands Trial Register (NTR): 4169; http://www.trialregister.nl/trialreg/admin/rctview.asp?TC=4169 (Archived by WebCite at http://www.webcitation.org/6VD2jnxmB).
78 FR 12322 - Agency Information Collection Activities: OMB Review; Comment Request
2013-02-22
... Interchange (EDI) Registration and Electronic Data Interchange (EDI) Enrollment Form; Use: The purpose of this... identification of Medicare providers/suppliers and authorization of requested Electronic Data Interface (EDI) functions. The EDI Enrollment and the Medicare Registration Forms are completed by Medicare providers...
Full Text Available ... and evaluated to fill an important gap in information and education for parents, clinicians, researchers, children, and the general public. What to Expect During a clinical trial, ...
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Annema Coby
2010-05-01
Full Text Available Abstract Background Case management has been suggested as an innovative strategy that facilitates the improvement of a patient's quality of life, reduction of hospital length of stay, optimization of self-care and improvement of satisfaction of patients and professionals involved. However, there is little evidence about the effectiveness of the patient advocacy case management model in clinical practice. Therefore, the objective of our study was to examine the effects of the Dutch patient advocacy case management model for severely disabled Multiple Sclerosis (MS patients and their caregivers compared to usual care. Methods/design In this randomized controlled trial the effectiveness of casemanagement on quality of life of patients and their caregivers, quality of care, service use and economic aspects were evaluated. The primary outcomes of this study were quality of life of MS-patients and caregiver burden of caregivers. Furthermore, we examined quality of life of caregivers, quality of care, service use and costs. Discussion This is a unique trial in which we examined the effectiveness of case management from a broad perspective. We meticulously prepared this study and applied important features and created important conditions for both intervention and research protocol to increase the likelihood of finding evidence for the effectiveness of patient advocacy case management. Concerning the intervention we anticipated to five important conditions: 1 the contrast between the case management intervention compared to the usual care seems to be large enough to detect intervention effects; 2 we included patients with complex care situations and/or were at risk for critical situations; 3 the case managers were familiar with disease specific health-problems and a broad spectrum of solutions; 4 case managers were competent and authorized to perform a medical neurological examination and worked closely with neurologists specialized in MS; and 5 the
Bennett, C L; Stinson, T J; Vogel, V; Robertson, L; Leedy, D; O'Brien, P; Hobbs, J; Sutton, T; Ruckdeschel, J C; Chirikos, T N; Weiner, R S; Ramsey, M M; Wicha, M S
2000-08-01
Medical care for clinical trials is often not reimbursed by insurers, primarily because of concern that medical care as part of clinical trials is expensive and not part of standard medical practice. In June 2000, President Clinton ordered Medicare to reimburse for medical care expenses incurred as part of cancer clinical trials, although many private insurers are concerned about the expense of this effort. To inform this policy debate, the costs and charges of care for patients on clinical trials are being evaluated. In this Association of American Cancer Institutes (AACI) Clinical Trials Costs and Charges pilot study, we describe the results and operational considerations of one of the first completed multisite economic analyses of clinical trials. Our pilot effort included assessment of total direct medical charges for 6 months of care for 35 case patients who received care on phase II clinical trials and for 35 matched controls (based on age, sex, disease, stage, and treatment period) at five AACI member cancer centers. Charge data were obtained for hospital and ancillary services from automated claims files at individual study institutions. The analyses were based on the perspective of a third-party payer. The mean age of the phase II clinical trial patients was 58.3 years versus 57.3 years for control patients. The study population included persons with cancer of the breast (n = 24), lung (n = 18), colon (n = 16), prostate (n = 4), and lymphoma (n = 8). The ratio of male-to-female patients was 3:4, with greater than 75% of patients having stage III to IV disease. Total mean charges for treatment from the time of study enrollment through 6 months were similar: $57,542 for clinical trial patients and $63,721 for control patients (1998 US$; P =.4) Multisite economic analyses of oncology clinical trials are in progress. Strategies that are not likely to overburden data managers and clinicians are possible to devise. However, these studies require careful planning
Evaluating Protocol Lifecycle Time Intervals in HIV/AIDS Clinical Trials
Schouten, Jeffrey T.; Dixon, Dennis; Varghese, Suresh; Cope, Marie T.; Marci, Joe; Kagan, Jonathan M.
2014-01-01
Background Identifying efficacious interventions for the prevention and treatment of human diseases depends on the efficient development and implementation of controlled clinical trials. Essential to reducing the time and burden of completing the clinical trial lifecycle is determining which aspects take the longest, delay other stages, and may lead to better resource utilization without diminishing scientific quality, safety, or the protection of human subjects. Purpose In this study we modeled time-to-event data to explore relationships between clinical trial protocol development and implementation times, as well as identify potential correlates of prolonged development and implementation. Methods We obtained time interval and participant accrual data from 111 interventional clinical trials initiated between 2006 and 2011 by NIH’s HIV/AIDS Clinical Trials Networks. We determined the time (in days) required to complete defined phases of clinical trial protocol development and implementation. Kaplan-Meier estimates were used to assess the rates at which protocols reached specified terminal events, stratified by study purpose (therapeutic, prevention) and phase group (pilot/phase I, phase II, and phase III/ IV). We also examined several potential correlates to prolonged development and implementation intervals. Results Even though phase grouping did not determine development or implementation times of either therapeutic or prevention studies, overall we observed wide variation in protocol development times. Moreover, we detected a trend toward phase III/IV therapeutic protocols exhibiting longer developmental (median 2 ½ years) and implementation times (>3years). We also found that protocols exceeding the median number of days for completing the development interval had significantly longer implementation. Limitations The use of a relatively small set of protocols may have limited our ability to detect differences across phase groupings. Some timing effects
International Nuclear Information System (INIS)
Eysink, W.D.; Wang, Z.; Dijkema, K.S.; Slim, P.A.; Dankers, N.M.J.A.; Sanders, M.E.; Van Dobben, H.F.; Krol, J.; Kersten, M.; Molenaar, W.; Doornhof, D.; Schoustra, S.; Veldwisch, W.
2005-05-01
After the start of the natural gas exploitation on the Dutch island Ameland in 1986 surveys were carried out from 1988 on to investigate and monitor the effect of the exploitation on land subsidence and related environmental effects. In this third report evaluated results of that survey over the last 18 years are presented and discussed [nl
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Bruinvels David J
2009-05-01
Full Text Available Abstract Background Individuals claiming a disability benefit after long-term sickness absence, have to undergo medical disability assessments. These assessments, often carried out by specialized physicians, can be complicated by wrong expectations or defensive attitudes of disability benefit claimants. It is hypothesized that empowerment of these claimants will enhance the physician-patient relationship by shifting claimants from a passive role to a more active and constructive role during disability assessments. Furthermore, empowerment of claimants may lead to a more realistic expectation and acceptance of the assessment outcome among claimants and may lead to a more accurate assessment by the physician. Methods/Design In a two-armed randomized controlled trial (RCT, 230 claimants will be randomized to either the intervention or control group. For the intervention group, an interactive website was designed http://www.wiagesprek.nl using an Intervention Mapping procedure. This website was tested during a pilot study among 51 claimants. The final version of the website consists of five interactive modules, in which claimants will be prepared and empowered step-by-step, prior to their upcoming disability assessment. Other website components are a forum, a personal health record, a personal diary, and information on disability assessment procedures, return to work, and coping with disease and work disability. Subjects from the control group will be directed to a website with commonly available information only. Approximately two weeks prior to their disability assessment, disability claimants will be recruited through the Dutch Workers Insurance Authority (UWV. Outcomes will be assessed at five occasions: directly after recruitment (baseline, prior to disability assessment, directly after disability assessment as well as 6 and 16 weeks after the assessment. The study's primary outcome is empowerment, measured with the Vrijbaan questionnaire
van de Glind, I; Bunn, C; Gray, C M; Hunt, K; Andersen, E; Jelsma, J; Morgan, H; Pereira, H; Roberts, G; Rooksby, J; Røynesdal, Ø; Silva, M; Sorensen, M; Treweek, S; van Achterberg, T; van der Ploeg, H; van Nassau, F; Nijhuis-van der Sanden, M; Wyke, S
2017-07-27
EuroFIT is a gender-sensitised, health and lifestyle program targeting physical activity, sedentary time and dietary behaviours in men. The delivery of the program in football clubs, led by the clubs' community coaches, is designed to both attract and engage men in lifestyle change through an interest in football or loyalty to the club they support. The EuroFIT program will be evaluated in a multicentre pragmatic randomised controlled trial (RCT), for which ~1000 overweight men, aged 30-65 years, will be recruited in 15 top professional football clubs in the Netherlands, Norway, Portugal and the UK. The process evaluation is designed to investigate how implementation within the RCT is achieved in the various football clubs and countries and the processes through which EuroFIT affects outcomes. This mixed methods evaluation is guided by the Medical Research Council (MRC) guidance for conducting process evaluations of complex interventions. Data will be collected in the intervention arm of the EuroFIT trial through: participant questionnaires (n = 500); attendance sheets and coach logs (n = 360); observations of sessions (n = 30); coach questionnaires (n = 30); usage logs from a novel device for self-monitoring physical activity and non-sedentary behaviour (SitFIT); an app-based game to promote social support for physical activity outside program sessions (MatchFIT); interviews with coaches (n = 15); football club representatives (n = 15); and focus groups with participants (n = 30). Written standard operating procedures are used to ensure quality and consistency in data collection and analysis across the participating countries. Data will be analysed thematically within datasets and overall synthesis of findings will address the processes through which the program is implemented in various countries and clubs and through which it affects outcomes, with careful attention to the context of the football club. The process evaluation will
Oligonucleic Acid Drug List: monrd0026 [Oligonucleic Acid Drug Database[Archive
Lifescience Database Archive (English)
Full Text Available nicaltrialsregister.eu/ctr-search/trial/2010-019057-17/NL, http://nar.oxfordjournals.org/content/42/1/609.full, http://www.news-medic...al.net/news/20111004/14772/Japanese.aspx, http://mirnabl
Oligonucleic Acid Drug List: monrd0025 [Oligonucleic Acid Drug Database[Archive
Lifescience Database Archive (English)
Full Text Available com/kynamro-drug.htm, http://www.kegg.jp/dbget-bin/www_bget?D08946, https://www.clinicaltrialsregister.eu/ct...r-search/trial/2004-003934-32/DE, https://www.clinicaltrialsregister.eu/ctr-searc...h/trial/2005-003449-15/GB, http://www.ncbi.nlm.nih.gov/pubmed/21210756 https://www.clinicaltrialsregister.eu.../ctr-search/trial/2005-003450-10/GB, https://www.clinicaltrialsregister.eu/ctr-search/trial/2007-005140-24/N...L, https://www.clinicaltrialsregister.eu/ctr-search/trial/2011-001480-42/ES, https://www.clinicaltrialsreg
Directory of Open Access Journals (Sweden)
Lassere Marissa N
2012-03-01
Full Text Available Abstract Background Blood pressure is considered to be a leading example of a valid surrogate endpoint. The aims of this study were to (i formally evaluate systolic and diastolic blood pressure reduction as a surrogate endpoint for stroke prevention and (ii determine what blood pressure reduction would predict a stroke benefit. Methods We identified randomised trials of at least six months duration comparing any pharmacologic anti-hypertensive treatment to placebo or no treatment, and reporting baseline blood pressure, on-trial blood pressure, and fatal and non-fatal stroke. Trials with fewer than five strokes in at least one arm were excluded. Errors-in-variables weighted least squares regression modelled the reduction in stroke as a function of systolic blood pressure reduction and diastolic blood pressure reduction respectively. The lower 95% prediction band was used to determine the minimum systolic blood pressure and diastolic blood pressure difference, the surrogate threshold effect (STE, below which there would be no predicted stroke benefit. The STE was used to generate the surrogate threshold effect proportion (STEP, a surrogacy metric, which with the R-squared trial-level association was used to evaluate blood pressure as a surrogate endpoint for stroke using the Biomarker-Surrogacy Evaluation Schema (BSES3. Results In 18 qualifying trials representing all pharmacologic drug classes of antihypertensives, assuming a reliability coefficient of 0.9, the surrogate threshold effect for a stroke benefit was 7.1 mmHg for systolic blood pressure and 2.4 mmHg for diastolic blood pressure. The trial-level association was 0.41 and 0.64 and the STEP was 66% and 78% for systolic and diastolic blood pressure respectively. The STE and STEP were more robust to measurement error in the independent variable than R-squared trial-level associations. Using the BSES3, assuming a reliability coefficient of 0.9, systolic blood pressure was a B + grade and
Brinkman, Sally A; Johnson, Sarah E; Lawrence, David; Codde, James P; Hart, Michael B; Straton, Judith A Y; Silburn, Sven
2010-10-21
This paper presents the study protocol for a pragmatic randomised controlled trial to evaluate the impact of a school based program developed to prevent teenage pregnancy. The program includes students taking care of an Infant Simulator; despite growing popularity and an increasing global presence of such programs, there is no published evidence of their long-term impact. The aim of this trial is to evaluate the Virtual Infant Parenting (VIP) program by investigating pre-conceptual health and risk behaviours, teen pregnancy and the resultant birth outcomes, early child health and maternal health. Fifty-seven schools (86% of 66 eligible secondary schools) in Perth, Australia were recruited to the clustered (by school) randomised trial, with even randomisation to the intervention and control arms. Between 2003 and 2006, the VIP program was administered to 1,267 participants in the intervention schools, while 1,567 participants in the non-intervention schools received standard curriculum. Participants were all female and aged between 13-15 years upon recruitment. Pre and post-intervention questionnaires measured short-term impact and participants are now being followed through their teenage years via data linkage to hospital medical records, abortion clinics and education records. Participants who have a live birth are interviewed by face-to-face interview. Kaplan-Meier survival analysis and proportional hazards regression will test for differences in pregnancy, birth and abortion rates during the teenage years between the study arms. This protocol paper provides a detailed overview of the trial design as well as initial results in the form of participant flow. The authors describe the intervention and its delivery within the natural school setting and discuss the practical issues in the conduct of the trial, including recruitment. The trial is pragmatic and will directly inform those who provide Infant Simulator based programs in school settings. ISRCTN24952438.
Recruitment to publicly funded trials--are surgical trials really different?
Cook, Jonathan A; Ramsay, Craig R; Norrie, John
2008-09-01
Good recruitment is integral to the conduct of a high-quality randomised controlled trial. It has been suggested that recruitment is particularly difficult for evaluations of surgical interventions, a field in which there is a dearth of evidence from randomised comparisons. While there is anecdotal speculation to support the inference that recruitment to surgical trials is more challenging than for medical trials we are unaware of any formal assessment of this. In this paper, we compare recruitment to surgical and medical trials using a cohort of publicly funded trials. Overall recruitment to trials was assessed using of a cohort of publicly funded trials (n=114). Comparisons were made by using the Recruitment Index, a simple measure of recruitment activity for multicentre randomised controlled trials. Recruitment at the centre level was also investigated through three example surgical trials. The Recruitment Index was found to be higher, though not statistically significantly, in the surgical group (n=18, median=38.0 IQR (10.7, 77.4)) versus (n=81, median=34.8 IQR (11.7, 98.0)) days per recruit for the medical group (median difference 1.7 (-19.2, 25.1); p=0.828). For the trials where the comparison was between a surgical and a medical intervention, the Recruitment Index was substantially higher (n=6, 68.3 (23.5, 294.8)) versus (n=93, 34.6 (11.7, 90.0); median difference 25.9 (-35.5, 221.8); p=0.291) for the other trials. There was no clear evidence that surgical trials differ from medical trials in terms of recruitment activity. There was, however, support for the inference that medical versus surgical trials are more difficult to recruit to. Formal exploration of the recruitment data through a modelling approach may go some way to tease out where important differences exist.
Brealey, Stephen D; Atwell, Christine; Bryan, Stirling; Coulton, Simon; Cox, Helen; Cross, Ben; Fylan, Fiona; Garratt, Andrew; Gilbert, Fiona J; Gillan, Maureen GC; Hendry, Maggie; Hood, Kerenza; Houston, Helen; King, David; Morton, Veronica; Orchard, Jo; Robling, Michael; Russell, Ian T; Torgerson, David; Wadsworth, Valerie; Wilkinson, Clare
2006-01-01
Background Though new technologies like Magnetic Resonance Imaging (MRI) may be accurate, they often diffuse into practice before thorough assessment of their value in diagnosis and management, and of their effects on patient outcome and costs. MRI of the knee is a common investigation despite concern that it is not always appropriate. There is wide variation in general practitioners (GPs) access to, and use of MRI, and in the associated costs. The objective of this study was to resolve uncertainty whether GPs should refer patients with suspected internal derangement of the knee for MRI or to an orthopaedic specialist in secondary care. Methods/Design The design consisted of a pragmatic multi-centre randomised trial with two parallel groups and concomitant economic evaluation. Patients presenting in general practice with suspected internal derangement of the knee and for whom their GP was considering referral to an orthopaedic specialist in secondary care were eligible for inclusion. Within practices, GPs or practice nurses randomised eligible and consenting participants to the local radiology department for an MRI examination, or for consultation with an orthopaedic specialist. To ensure that the waiting time from GP consultation to orthopaedic appointment was similar for both trial arms, GPs made a provisional referral to orthopaedics when requesting the MRI examination. Thus we evaluated the more appropriate sequence of events independent of variations in waiting times. Follow up of participants was by postal questionnaires at six, twelve and 24 months after randomisation. This was to ensure that the evaluation covered all events up to and including arthroscopy. Discussion The DAMASK trial should make a major contribution to the development of evidence-based partnerships between primary and secondary care professionals and inform the debate when MRI should enter the diagnostic pathway. PMID:17040558
Directory of Open Access Journals (Sweden)
Orchard Jo
2006-10-01
Full Text Available Abstract Background Though new technologies like Magnetic Resonance Imaging (MRI may be accurate, they often diffuse into practice before thorough assessment of their value in diagnosis and management, and of their effects on patient outcome and costs. MRI of the knee is a common investigation despite concern that it is not always appropriate. There is wide variation in general practitioners (GPs access to, and use of MRI, and in the associated costs. The objective of this study was to resolve uncertainty whether GPs should refer patients with suspected internal derangement of the knee for MRI or to an orthopaedic specialist in secondary care. Methods/Design The design consisted of a pragmatic multi-centre randomised trial with two parallel groups and concomitant economic evaluation. Patients presenting in general practice with suspected internal derangement of the knee and for whom their GP was considering referral to an orthopaedic specialist in secondary care were eligible for inclusion. Within practices, GPs or practice nurses randomised eligible and consenting participants to the local radiology department for an MRI examination, or for consultation with an orthopaedic specialist. To ensure that the waiting time from GP consultation to orthopaedic appointment was similar for both trial arms, GPs made a provisional referral to orthopaedics when requesting the MRI examination. Thus we evaluated the more appropriate sequence of events independent of variations in waiting times. Follow up of participants was by postal questionnaires at six, twelve and 24 months after randomisation. This was to ensure that the evaluation covered all events up to and including arthroscopy. Discussion The DAMASK trial should make a major contribution to the development of evidence-based partnerships between primary and secondary care professionals and inform the debate when MRI should enter the diagnostic pathway.
DEFF Research Database (Denmark)
Wildt, Signe; Krag, Aleksander; Gluud, Liselotte
2011-01-01
Objectives To evaluate the adequacy of reporting of protocols for randomised trials on diseases of the digestive system registered in http://ClinicalTrials.gov and the consistency between primary outcomes, secondary outcomes and sample size specified in http://ClinicalTrials.gov and published...
Directory of Open Access Journals (Sweden)
Winstein Carolee J
2013-01-01
Full Text Available Abstract Background Residual disability after stroke is substantial; 65% of patients at 6 months are unable to incorporate the impaired upper extremity into daily activities. Task-oriented training programs are rapidly being adopted into clinical practice. In the absence of any consensus on the essential elements or dose of task-specific training, an urgent need exists for a well-designed trial to determine the effectiveness of a specific multidimensional task-based program governed by a comprehensive set of evidence-based principles. The Interdisciplinary Comprehensive Arm Rehabilitation Evaluation (ICARE Stroke Initiative is a parallel group, three-arm, single blind, superiority randomized controlled trial of a theoretically-defensible, upper extremity rehabilitation program provided in the outpatient setting. The primary objective of ICARE is to determine if there is a greater improvement in arm and hand recovery one year after randomization in participants receiving a structured training program termed Accelerated Skill Acquisition Program (ASAP, compared to participants receiving usual and customary therapy of an equivalent dose (DEUCC. Two secondary objectives are to compare ASAP to a true (active monitoring only usual and customary (UCC therapy group and to compare DEUCC and UCC. Methods/design Following baseline assessment, participants are randomized by site, stratified for stroke duration and motor severity. 360 adults will be randomized, 14 to 106 days following ischemic or hemorrhagic stroke onset, with mild to moderate upper extremity impairment, recruited at sites in Atlanta, Los Angeles and Washington, D.C. The Wolf Motor Function Test (WMFT time score is the primary outcome at 1 year post-randomization. The Stroke Impact Scale (SIS hand domain is a secondary outcome measure. The design includes concealed allocation during recruitment, screening and baseline, blinded outcome assessment and intention to treat analyses. Our primary
Directory of Open Access Journals (Sweden)
Hart Michael B
2010-10-01
Full Text Available Abstract Background This paper presents the study protocol for a pragmatic randomised controlled trial to evaluate the impact of a school based program developed to prevent teenage pregnancy. The program includes students taking care of an Infant Simulator; despite growing popularity and an increasing global presence of such programs, there is no published evidence of their long-term impact. The aim of this trial is to evaluate the Virtual Infant Parenting (VIP program by investigating pre-conceptual health and risk behaviours, teen pregnancy and the resultant birth outcomes, early child health and maternal health. Methods and Design Fifty-seven schools (86% of 66 eligible secondary schools in Perth, Australia were recruited to the clustered (by school randomised trial, with even randomisation to the intervention and control arms. Between 2003 and 2006, the VIP program was administered to 1,267 participants in the intervention schools, while 1,567 participants in the non-intervention schools received standard curriculum. Participants were all female and aged between 13-15 years upon recruitment. Pre and post-intervention questionnaires measured short-term impact and participants are now being followed through their teenage years via data linkage to hospital medical records, abortion clinics and education records. Participants who have a live birth are interviewed by face-to-face interview. Kaplan-Meier survival analysis and proportional hazards regression will test for differences in pregnancy, birth and abortion rates during the teenage years between the study arms. Discussion This protocol paper provides a detailed overview of the trial design as well as initial results in the form of participant flow. The authors describe the intervention and its delivery within the natural school setting and discuss the practical issues in the conduct of the trial, including recruitment. The trial is pragmatic and will directly inform those who provide
Knowlden, Adam P; Sharma, Manoj
2014-09-01
Family-and-home-based interventions are an important vehicle for preventing childhood obesity. Systematic process evaluations have not been routinely conducted in assessment of these interventions. The purpose of this study was to plan and conduct a process evaluation of the Enabling Mothers to Prevent Pediatric Obesity Through Web-Based Learning and Reciprocal Determinism (EMPOWER) randomized control trial. The trial was composed of two web-based, mother-centered interventions for prevention of obesity in children between 4 and 6 years of age. Process evaluation used the components of program fidelity, dose delivered, dose received, context, reach, and recruitment. Categorical process evaluation data (program fidelity, dose delivered, dose exposure, and context) were assessed using Program Implementation Index (PII) values. Continuous process evaluation variables (dose satisfaction and recruitment) were assessed using ANOVA tests to evaluate mean differences between groups (experimental and control) and sessions (sessions 1 through 5). Process evaluation results found that both groups (experimental and control) were equivalent, and interventions were administered as planned. Analysis of web-based intervention process objectives requires tailoring of process evaluation models for online delivery. Dissemination of process evaluation results can advance best practices for implementing effective online health promotion programs. © 2014 Society for Public Health Education.
DEFF Research Database (Denmark)
van Middelkoop, Marienke; Arden, N K; Atchia, I.
2016-01-01
Objective: To evaluate the efficacy of intra-articular (IA) glucocorticoids for knee or hip osteoarthritis (OA) in specific subgroups of patients with severe pain and inflammatory signs using individual patient data (IPD) from existing trials. Design: Randomized trials evaluating one or more IA...... glucocorticoid preparation in patients with knee or hip OA, published from 1995 up to June 2012 were selected from the literature. IPD obtained from original trials included patient and disease characteristics and outcomes measured. The primary outcome was pain severity at short-term follow-up (up to 4 weeks...... Interval 1.50-26.31) when receiving IA glucocorticoid injection compared to placebo. No statistical significant interaction effects were found between inflammatory signs and IA glucocorticoid injections compared to placebo and to tidal irrigation at all follow-up points. Conclusions: This IPD meta...
Joint probability of statistical success of multiple phase III trials.
Zhang, Jianliang; Zhang, Jenny J
2013-01-01
In drug development, after completion of phase II proof-of-concept trials, the sponsor needs to make a go/no-go decision to start expensive phase III trials. The probability of statistical success (PoSS) of the phase III trials based on data from earlier studies is an important factor in that decision-making process. Instead of statistical power, the predictive power of a phase III trial, which takes into account the uncertainty in the estimation of treatment effect from earlier studies, has been proposed to evaluate the PoSS of a single trial. However, regulatory authorities generally require statistical significance in two (or more) trials for marketing licensure. We show that the predictive statistics of two future trials are statistically correlated through use of the common observed data from earlier studies. Thus, the joint predictive power should not be evaluated as a simplistic product of the predictive powers of the individual trials. We develop the relevant formulae for the appropriate evaluation of the joint predictive power and provide numerical examples. Our methodology is further extended to the more complex phase III development scenario comprising more than two (K > 2) trials, that is, the evaluation of the PoSS of at least k₀ (k₀≤ K) trials from a program of K total trials. Copyright © 2013 John Wiley & Sons, Ltd.
Fundamentals of clinical trials
Friedman, Lawrence M; DeMets, David L; Reboussin, David M; Granger, Christopher B
2015-01-01
This is the fifth edition of a very successful textbook on clinical trials methodology, written by recognized leaders who have long and extensive experience in all areas of clinical trials. The three authors of the first four editions have been joined by two others who add great expertise. Most chapters have been revised considerably from the fourth edition. A chapter on regulatory issues has been included and the chapter on data monitoring has been split into two and expanded. Many contemporary clinical trial examples have been added. There is much new material on adverse events, adherence, issues in analysis, electronic data, data sharing, and international trials. This book is intended for the clinical researcher who is interested in designing a clinical trial and developing a protocol. It is also of value to researchers and practitioners who must critically evaluate the literature of published clinical trials and assess the merits of each trial and the implications for the care and treatment of ...
Evaluating the Use of Plain Language in a Cancer Clinical Trial Website/App.
Schultz, Paula L; Carlisle, Regina; Cheatham, Chesley; O'Grady, Melissa
2017-12-01
Medically complex titles and descriptions found on clinical trial websites and online applications present a barrier to comprehension for users from the general public. In this study, we examine the effectiveness of plain language trial descriptions for user comprehension of basic trial details. Two hundred seventeen volunteers recruited from patient waiting areas completed 441 user tests of ten plain language trial descriptions. The majority of volunteers adequately comprehended the cancer type and basic inclusion/exclusion criteria from plain language trial descriptions. Difficulty comprehending the treatment being studied was seen in seven of ten descriptions tested. Revision and retesting of the seven trial descriptions showed continued user challenges in comprehending the treatment being studied. Plain language clinical trial descriptions integrated into a website/app allowed users to understand basic inclusion/exclusion criteria. Despite plain language used, discerning the treatment being studied may be difficult for some users. Integration of plain language descriptions into clinical trial online applications can help users understand trial basics. Further research regarding effective use of plain language to communicate the treatment being studied is needed.
Nam, W. H.; Hayes, M. J.; Svoboda, M. D.; Fuchs, B.; Tadesse, T.; Wilhite, D. A.; Hong, E. M.; Kim, T.
2017-12-01
South Korea has experienced extreme droughts in 1994-1995, 2000-2001, 2012, 2015, and 2016-2017. The 2017 spring drought (with especially low winter precipitation recorded in winter 2016) affected a large portion of central and western South Korea, and was one of the most severe droughts in the region since the 2000-2001 drought. The spring drought of 2017 was characterized by exceptionally low precipitation with total precipitation from January to June being 50% lower than the mean normal precipitation record (1981-2010) over most of western South Korea. It was the climatologically driest spring over the 1961-2016 record period. Effective drought monitoring and management depends on which drought indices are selected because each drought index has different drought criteria or levels of drought severity, associated with drought responses. In this study, for the quantitative analysis of the spring 2017 drought event in South Korea, four widely-used drought indices, including the Standardized Precipitation Index (SPI), the Standardized Precipitation Evapotranspiration Index (SPEI), the Self-Calibrated Palmer Drought Severity Index (SC-PDSI), and the Effective Drought Index (EDI) are compared with observed drought damaged areas in the context of agricultural drought impacts. The South Korean government (Ministry of Agriculture, Food and Rural Affairs (MAFRA) and Korea Rural Community Corporation (KRC)) has been operating a government-level drought monitoring system since 2016. Results from this study can be used to improve the drought monitoring applications, as well as drought planning and preparedness in South Korea.
Wang, Ximing; Kim, Bokkyu; Park, Ji Hoon; Wang, Erik; Forsyth, Sydney; Lim, Cody; Ravi, Ragini; Karibyan, Sarkis; Sanchez, Alexander; Liu, Brent
2017-03-01
Quantitative imaging biomarkers are used widely in clinical trials for tracking and evaluation of medical interventions. Previously, we have presented a web based informatics system utilizing quantitative imaging features for predicting outcomes in stroke rehabilitation clinical trials. The system integrates imaging features extraction tools and a web-based statistical analysis tool. The tools include a generalized linear mixed model(GLMM) that can investigate potential significance and correlation based on features extracted from clinical data and quantitative biomarkers. The imaging features extraction tools allow the user to collect imaging features and the GLMM module allows the user to select clinical data and imaging features such as stroke lesion characteristics from the database as regressors and regressands. This paper discusses the application scenario and evaluation results of the system in a stroke rehabilitation clinical trial. The system was utilized to manage clinical data and extract imaging biomarkers including stroke lesion volume, location and ventricle/brain ratio. The GLMM module was validated and the efficiency of data analysis was also evaluated.
Helms, Ronald W; Reece, Laura Helms; Helms, Russell W; Helms, Mary W
2011-03-01
Missing not at random (MNAR) post-dropout missing data from a longitudinal clinical trial result in the collection of "biased data," which leads to biased estimators and tests of corrupted hypotheses. In a full rank linear model analysis the model equation, E[Y] = Xβ, leads to the definition of the primary parameter β = (X'X)(-1)X'E[Y], and the definition of linear secondary parameters of the form θ = Lβ = L(X'X)(-1)X'E[Y], including, for example, a parameter representing a "treatment effect." These parameters depend explicitly on E[Y], which raises the questions: What is E[Y] when some elements of the incomplete random vector Y are not observed and MNAR, or when such a Y is "completed" via imputation? We develop a rigorous, readily interpretable definition of E[Y] in this context that leads directly to definitions of β, Bias(β) = E[β] - β, Bias(θ) = E[θ] - Lβ, and the extent of hypothesis corruption. These definitions provide a basis for evaluating, comparing, and removing biases induced by various linear imputation methods for MNAR incomplete data from longitudinal clinical trials. Linear imputation methods use earlier data from a subject to impute values for post-dropout missing values and include "Last Observation Carried Forward" (LOCF) and "Baseline Observation Carried Forward" (BOCF), among others. We illustrate the methods of evaluating, comparing, and removing biases and the effects of testing corresponding corrupted hypotheses via a hypothetical but very realistic longitudinal analgesic clinical trial.
Meurer, William J; Seewald, Nicholas J; Kidwell, Kelley
2017-04-01
Modern clinical trials in stroke reperfusion fall into 2 categories: alternative systemic pharmacological regimens to alteplase and "rescue" endovascular approaches using targeted thrombectomy devices and/or medications delivered directly for persistently occluded vessels. Clinical trials in stroke have not evaluated how initial pharmacological thrombolytic management might influence subsequent rescue strategy. A sequential multiple assignment randomized trial (SMART) is a novel trial design that can test these dynamic treatment regimens and lead to treatment guidelines that more closely mimic practice. To characterize a SMART design in comparison to traditional approaches for stroke reperfusion trials. We conducted a numerical simulation study that evaluated the performance of contrasting acute stroke clinical trial designs of both initial reperfusion and rescue therapy. We compare a SMART design where the same patients are followed through initial reperfusion and rescue therapy within 1 trial to a standard phase III design comparing 2 reperfusion treatments and a separate phase II futility design of rescue therapy in terms of sample size, power, and ability to address particular research questions. Traditional trial designs can be well powered and have optimal design characteristics for independent treatment effects. When treatments, such as the reperfusion and rescue therapies, may interact, commonly used designs fail to detect this. A SMART design, with similar sample size to standard designs, can detect treatment interactions. The use of SMART designs to investigate effective and realistic dynamic treatment regimens is a promising way to accelerate the discovery of new, effective treatments for stroke. Copyright © 2017 National Stroke Association. Published by Elsevier Inc. All rights reserved.
Clinical trials of homoeopathy.
Kleijnen, J; Knipschild, P; ter Riet, G
1991-01-01
OBJECTIVE--To establish whether there is evidence of the efficacy of homoeopathy from controlled trials in humans. DESIGN--Criteria based meta-analysis. Assessment of the methodological quality of 107 controlled trials in 96 published reports found after an extensive search. Trials were scored using a list of predefined criteria of good methodology, and the outcome of the trials was interpreted in relation to their quality. SETTING--Controlled trials published world wide. MAIN OUTCOME MEASURES--Results of the trials with the best methodological quality. Trials of classical homoeopathy and several modern varieties were considered separately. RESULTS--In 14 trials some form of classical homoeopathy was tested and in 58 trials the same single homoeopathic treatment was given to patients with comparable conventional diagnosis. Combinations of several homoeopathic treatments were tested in 26 trials; isopathy was tested in nine trials. Most trials seemed to be of very low quality, but there were many exceptions. The results showed a positive trend regardless of the quality of the trial or the variety of homeopathy used. Overall, of the 105 trials with interpretable results, 81 trials indicated positive results whereas in 24 trials no positive effects of homoeopathy were found. The results of the review may be complicated by publication bias, especially in such a controversial subject as homoeopathy. CONCLUSIONS--At the moment the evidence of clinical trials is positive but not sufficient to draw definitive conclusions because most trials are of low methodological quality and because of the unknown role of publication bias. This indicates that there is a legitimate case for further evaluation of homoeopathy, but only by means of well performed trials. PMID:1825800
Quantitative evaluation of muscle synergy models: a single-trial task decoding approach.
Delis, Ioannis; Berret, Bastien; Pozzo, Thierry; Panzeri, Stefano
2013-01-01
Muscle synergies, i.e., invariant coordinated activations of groups of muscles, have been proposed as building blocks that the central nervous system (CNS) uses to construct the patterns of muscle activity utilized for executing movements. Several efficient dimensionality reduction algorithms that extract putative synergies from electromyographic (EMG) signals have been developed. Typically, the quality of synergy decompositions is assessed by computing the Variance Accounted For (VAF). Yet, little is known about the extent to which the combination of those synergies encodes task-discriminating variations of muscle activity in individual trials. To address this question, here we conceive and develop a novel computational framework to evaluate muscle synergy decompositions in task space. Unlike previous methods considering the total variance of muscle patterns (VAF based metrics), our approach focuses on variance discriminating execution of different tasks. The procedure is based on single-trial task decoding from muscle synergy activation features. The task decoding based metric evaluates quantitatively the mapping between synergy recruitment and task identification and automatically determines the minimal number of synergies that captures all the task-discriminating variability in the synergy activations. In this paper, we first validate the method on plausibly simulated EMG datasets. We then show that it can be applied to different types of muscle synergy decomposition and illustrate its applicability to real data by using it for the analysis of EMG recordings during an arm pointing task. We find that time-varying and synchronous synergies with similar number of parameters are equally efficient in task decoding, suggesting that in this experimental paradigm they are equally valid representations of muscle synergies. Overall, these findings stress the effectiveness of the decoding metric in systematically assessing muscle synergy decompositions in task space.
2010-10-20
... interchange (EDI) for submitting advance ocean and rail data and intends to amend the regulations as [email protected] . Please describe in the body of the e-mail any past EDI history with CBP. Written... (EDI). For ocean and rail carriers, the CBP-approved EDI is the Automated Manifest System (AMS). Ocean...
Detecting Fraudulent Erasures at an Aggregate Level
Sinharay, Sandip
2018-01-01
Wollack, Cohen, and Eckerly suggested the "erasure detection index" (EDI) to detect fraudulent erasures for individual examinees. Wollack and Eckerly extended the EDI to detect fraudulent erasures at the group level. The EDI at the group level was found to be slightly conservative. This article suggests two modifications of the EDI for…
Currò, Vincenzo; Buonuomo, Paola Sabrina; Zambiano, Annaluce; Vituzzi, Andrea; Onesimo, Roberta; D'Atri, Alessandro
2007-01-01
The aim of this study is to verify the usefulness for parents of a web evaluation framework composed of ten quality criteria to improve their ability to assess the quality level of medical web sites. We conducted a randomised controlled trial that included two groups of parents who independently evaluated five paediatric web sites by filling out two distinct questionnaires: group A with the evaluation framework, group B without it. 40 volunteers were recruited from parents referring to the General Paediatrics Out-patients Department who satisfied the following eligibility criteria: Internet users, at least 1 child under 12 months old, no professional skill in Internet and medicine. The survey was taken between February 2, 2000 and March 22, 2000. Parents evaluated each web site and assigned a score, compared with a gold standard created by a group of experts. Suggesting evaluation criteria to parents seem useful for an improvement of their ability to evaluate web sites.
A new cognitive evaluation battery for Down syndrome and its relevance for clinical trials
Directory of Open Access Journals (Sweden)
Susana ede Sola
2015-06-01
Full Text Available The recent prospect of pharmaceutical interventions for cognitive impairment of Down syndrome(DS has boosted a number of clinical trials in this population. However, running the trials has raised some methodological challenges and questioned the prevailing methodology used to evaluate cognitive functioning of DS individuals. This is usually achieved by comparing DS individuals to matched healthy controls of the same mental age. We propose a new tool, the TESDAD Battery that uses comparison with age-matched typically developed adults. This is an advantageous method for probing the clinical efficacy of DS therapies, allowing the interpretation and prediction of functional outcomes in clinical trials. In our DS population the TESDAD battery permitted a quantitative assessment of cognitive defects, which indicated language dysfunction and deficits in executive function, as the most important contributors to other cognitive and adaptive behavior outcomes as predictors of functional change in DS. Concretely, auditory comprehension and functional academics showed the highest potential as end-point measures of therapeutic intervention for clinical trials: the former as a cognitive key target for therapeutic intervention, and the latter as a primary functional outcome measure of clinical efficacy. Our results also emphasize the need to explore the modulating effects of IQ, gender and age on cognitive enhancing treatments. Noticeably, women performed significantly better than men of the same age and IQ in most cognitive tests, with the most consistent differences occurring in memory and executive functioning and negative trends rarely emerged on quality of life linked to the effect of age after adjusting for IQ and gender. In sum, the TESDAD battery is a useful neurocognitive tool for probing the clinical efficacy of experimental therapies in interventional studies in the DS population suggesting that age-matched controls are advantageous for determining
Neuzil, Kathleen M; Zaman, K; Victor, John C
2014-08-11
Oral rotavirus vaccines have yielded different point estimates of efficacy when tested in different populations. While population and environmental factors may account for these differences, study design characteristics should also be considered. We review the study design elements of rotavirus vaccine trials that may affect point estimates of efficacy, and propose a framework for evaluating new rotavirus vaccines. Copyright © 2014. Published by Elsevier Ltd.
Decision theory and the evaluation of risks and benefits of clinical trials.
Bernabe, Rosemarie D C; van Thiel, Ghislaine J M W; Raaijmakers, Jan A M; van Delden, Johannes J M
2012-12-01
Research ethics committees (RECs) are tasked to assess the risks and the benefits of a clinical trial. In previous studies, it was shown that RECs find this task difficult, if not impossible, to do. The current approaches to benefit-risk assessment (i.e. Component Analysis and the Net Risk Test) confound the various risk-benefit tasks, and as such, make balancing impossible. In this article, we show that decision theory, specifically through the expected utility theory and multiattribute utility theory, enable for an explicit and ethically weighted risk-benefit evaluation. This makes a balanced ethical justification possible, and thus a more rationally defensible decision making. Copyright © 2012 Elsevier Ltd. All rights reserved.
2013-01-01
Shortcomings of earlier intervention studies in positive psychology will be tackled with this study, such as having a target group who is especially vulnerable for low well-being. The practice-based setting is especially interesting, as it can give valuable insights in how positive psychology interventions work in practice, but can also give rise to several challenges. Trial registration Dutch Trial Register, trial registration number TC=3377NTR. http://www.trialregister.nl/trialreg/admin/rctview.asp?TC=3377. PMID:24053566
Strategies to improve recruitment to randomised trials.
Treweek, Shaun; Pitkethly, Marie; Cook, Jonathan; Fraser, Cynthia; Mitchell, Elizabeth; Sullivan, Frank; Jackson, Catherine; Taskila, Tyna K; Gardner, Heidi
2018-02-22
Recruiting participants to trials can be extremely difficult. Identifying strategies that improve trial recruitment would benefit both trialists and health research. To quantify the effects of strategies for improving recruitment of participants to randomised trials. A secondary objective is to assess the evidence for the effect of the research setting (e.g. primary care versus secondary care) on recruitment. We searched the Cochrane Methodology Review Group Specialised Register (CMR) in the Cochrane Library (July 2012, searched 11 February 2015); MEDLINE and MEDLINE In Process (OVID) (1946 to 10 February 2015); Embase (OVID) (1996 to 2015 Week 06); Science Citation Index & Social Science Citation Index (ISI) (2009 to 11 February 2015) and ERIC (EBSCO) (2009 to 11 February 2015). Randomised and quasi-randomised trials of methods to increase recruitment to randomised trials. This includes non-healthcare studies and studies recruiting to hypothetical trials. We excluded studies aiming to increase response rates to questionnaires or trial retention and those evaluating incentives and disincentives for clinicians to recruit participants. We extracted data on: the method evaluated; country in which the study was carried out; nature of the population; nature of the study setting; nature of the study to be recruited into; randomisation or quasi-randomisation method; and numbers and proportions in each intervention group. We used a risk difference to estimate the absolute improvement and the 95% confidence interval (CI) to describe the effect in individual trials. We assessed heterogeneity between trial results. We used GRADE to judge the certainty we had in the evidence coming from each comparison. We identified 68 eligible trials (24 new to this update) with more than 74,000 participants. There were 63 studies involving interventions aimed directly at trial participants, while five evaluated interventions aimed at people recruiting participants. All studies were in
Full Text Available ... successfully developed and evaluated to fill an important gap in information and education for parents, clinicians, researchers, ... gathered can help others and add to scientific knowledge. People who take part in clinical trials are ...
Full Text Available ... Children and Clinical Studies Program has been successfully developed and evaluated to fill an important gap in ... Possible Benefits Taking part in a clinical trial can have many benefits. For example, you may gain ...
77 FR 70708 - VA Acquisition Regulation: Electronic Submission of Payment Requests
2012-11-27
... electronic data interchange (EDI) formats; or (3) another electronic form as prescribed by the contract....fsc.va.gov/einvoice.asp .); or, (b) A system that conforms to the X12 electronic data interchange (EDI... Institute (ANSI). The X12 EDI Web site ( http://www.x12.org ) includes additional information on EDI 810 and...
Landeg, Steven J; Kirby, Anna M; Lee, Steven F; Bartlett, Freddie; Titmarsh, Kumud; Donovan, Ellen; Griffin, Clare L; Gothard, Lone; Locke, Imogen; McNair, Helen A
2016-12-01
The purpose of this UK study was to evaluate interfraction reproducibility and body image score when using ultraviolet (UV) tattoos (not visible in ambient lighting) for external references during breast/chest wall radiotherapy and compare with conventional dark ink. In this non-blinded, single-centre, parallel group, randomized control trial, patients were allocated to receive either conventional dark ink or UV ink tattoos using computer-generated random blocks. Participant assignment was not masked. Systematic (∑) and random (σ) setup errors were determined using electronic portal images. Body image questionnaires were completed at pre-treatment, 1 month and 6 months to determine the impact of tattoo type on body image. The primary end point was to determine that UV tattoo random error (σ setup ) was no less accurate than with conventional dark ink tattoos, i.e. tattoos. 45 patients completed treatment (UV: n = 23, dark: n = 22). σ setup for the UV tattoo group was tattoo group compared with the dark ink group at 1 month [56% (13/23) vs 14% (3/22), respectively] and 6 months [52% (11/21) vs 38% (8/21), respectively]. UV tattoos were associated with interfraction setup reproducibility comparable with conventional dark ink. Patients reported a more favourable change in body image score up to 6 months following treatment. Advances in knowledge: This study is the first to evaluate UV tattoo external references in a randomized control trial.
Barnard, Rebecca A; Wittenburg, Luke A; Amaravadi, Ravi K; Gustafson, Daniel L; Thorburn, Andrew; Thamm, Douglas H
2014-08-01
Autophagy is a lysosomal degradation process that may act as a mechanism of survival in a variety of cancers. While pharmacologic inhibition of autophagy with hydroxychloroquine (HCQ) is currently being explored in human clinical trials, it has never been evaluated in canine cancers. Non-Hodgkin lymphoma (NHL) is one of the most prevalent tumor types in dogs and has similar pathogenesis and response to treatment as human NHL. Clinical trials in canine patients are conducted in the same way as in human patients, thus, to determine a maximum dose of HCQ that can be combined with a standard chemotherapy, a Phase I, single arm, dose escalation trial was conducted in dogs with spontaneous NHL presenting as patients to an academic, tertiary-care veterinary teaching hospital. HCQ was administered daily by mouth throughout the trial, beginning 72 h prior to doxorubicin (DOX), which was given intravenously on a 21-d cycle. Peripheral blood mononuclear cells and biopsies were collected before and 3 d after HCQ treatment and assessed for autophagy inhibition and HCQ concentration. A total of 30 patients were enrolled in the trial. HCQ alone was well tolerated with only mild lethargy and gastrointestinal-related adverse events. The overall response rate (ORR) for dogs with lymphoma was 93.3%, with median progression-free interval (PFI) of 5 mo. Pharmacokinetic analysis revealed a 100-fold increase in HCQ in tumors compared with plasma. There was a trend that supported therapy-induced increase in LC3-II (the cleaved and lipidated form of microtubule-associated protein 1 light chain 3/LC3, which serves as a maker for autophagosomes) and SQSTM1/p62 (sequestosome 1) after treatment. The superior ORR and comparable PFI to single-agent DOX provide strong support for further evaluation via randomized, placebo-controlled trials in canine and human NHL.
Energy Technology Data Exchange (ETDEWEB)
Davis, Robert G.; Wilkerson, Andrea M.; Samla, Connie; Bisbee, Dave
2016-08-31
This report summarizes the results from a trial installation of light-emitting diode (LED) lighting systems in several spaces within the ACC Care Center in Sacramento, CA. The Sacramento Municipal Utility District (SMUD) coordinated the project and invited the U.S. Department of Energy (DOE) to document the performance of the LED lighting systems as part of a GATEWAY evaluation. DOE tasked the Pacific Northwest National Laboratory (PNNL) to conduct the investigation. SMUD and ACC staff coordinated and completed the design and installation of the LED systems, while PNNL and SMUD staff evaluated the photometric performance of the systems. ACC staff also track behavioral and health measures of the residents; some of those results are reported here, although PNNL staff were not directly involved in collecting or interpreting those data. The trial installation took place in a double resident room and a single resident room, and the corridor that connects those (and other) rooms to the central nurse station. Other spaces in the trial included the nurse station, a common room called the family room located near the nurse station, and the ACC administrator’s private office.
Evaluating the statistical methodology of randomized trials on dentin hypersensitivity management.
Matranga, Domenica; Matera, Federico; Pizzo, Giuseppe
2017-12-27
The present study aimed to evaluate the characteristics and quality of statistical methodology used in clinical studies on dentin hypersensitivity management. An electronic search was performed for data published from 2009 to 2014 by using PubMed, Ovid/MEDLINE, and Cochrane Library databases. The primary search terms were used in combination. Eligibility criteria included randomized clinical trials that evaluated the efficacy of desensitizing agents in terms of reducing dentin hypersensitivity. A total of 40 studies were considered eligible for assessment of quality statistical methodology. The four main concerns identified were i) use of nonparametric tests in the presence of large samples, coupled with lack of information about normality and equality of variances of the response; ii) lack of P-value adjustment for multiple comparisons; iii) failure to account for interactions between treatment and follow-up time; and iv) no information about the number of teeth examined per patient and the consequent lack of cluster-specific approach in data analysis. Owing to these concerns, statistical methodology was judged as inappropriate in 77.1% of the 35 studies that used parametric methods. Additional studies with appropriate statistical analysis are required to obtain appropriate assessment of the efficacy of desensitizing agents.
Directory of Open Access Journals (Sweden)
Emmy Flores
2009-06-01
Full Text Available En el estado Zulia, Venezuela, se evaluó en un primer experimento el efecto de la posición de siembra (PS y el tiempo de almacenamiento (TA de semillas de Tamarindus indica L., y en un segundo ensayo se analizó la emergencia y las características morfológicas de las plántulas mediante un diseño totalmente aleatorizado. La PS correspondió a semillas sembradas con el hilo hacia abajo, el hilo hacia arriba colocadas horizontalmente; mientras que el TA fue de uno y ocho meses. Transcurridos 30 días, los efectos de la PS, el TA y la interacción PSxTA fueron significativos en el porcentaje de emergencia (PE, la tasa de emergencia (TE, la altura de la plántula (AP, la longitud de la raíz (LR, el número de hojas (NH y el número de nudos (NN por plántula. Las semillas con un mes de almacenamiento y sembradas con el hilo hacia abajo mostraron los mejores resultados (PE: 97,5%; TE: 22,3 días; mientras que las semillas recién cosechadas sin almacenamiento y sembradas con el hilo hacia abajo, aportaron resultados sobresalientes (PE: 96,56%; TE: 22,92 días. Se observó una correlación significativa en todas las variables medidas, excluyendo el NH con AC, y el DT con AC y NH. Se concluye que para propagar eficazmente T. indica y establecer sistemas agroforestales, se deben emplear semillas recién cosechadas o bien con un mes de almacenamiento, sembrándolas con el hilo hacia abajo.In the Zulia state, Venezuela, a first trial was conducted to evaluate the effect of planting position (PP and storage time (ST of Tamarindus indica L. seeds, and in a second trial the emergence and morphological characteristics of the seedlings were analyzed by means of a completely randomized design. The PP corresponded to seeds planted with the hilum facing down, the hilum facing up horizontally placed; while ST was one and eight months. After 30 days the effects of PP, ST and the PP x ST interaction were significant on the emergence percentage (EP, emergence
Emery, Sean; Abrams, Donald I; Cooper, David A; Darbyshire, Janet H; Lane, H Clifford; Lundgren, Jens D; Neaton, James D
2002-04-01
The Evaluation of Subcutaneous Proleukin in a Randomized International Trial (ESPRIT) is a large ongoing randomized trial of subcutaneous interleukin-2 (IL-2) plus antiretroviral therapy versus antiretroviral therapy alone in patients with HIV (human immunodeficiency virus) disease and CD4 cell counts of at least 300 cells/mm(3). The primary objective is to determine whether the addition of IL-2 to combination antiretroviral therapy improves morbidity and mortality. The aim is to recruit 4000 participants and follow them for an average of 5 years. Eligible subjects will be recruited at 275 investigational sites in 23 countries around the world. Coupled with broad eligibility criteria this will ensure widely applicable results. A range of secondary objectives will also be addressed in this setting that will include the conduct of observational studies and nested substudies with a public health focus. This article describes the rationale supporting the trial in addition to reviewing the study design, coordination, and governance.
Shah, Eric D; Siegel, Corey A; Chong, Kelly; Melmed, Gil Y
2016-04-01
We conducted a systematic review and meta-analysis to evaluate the efficacy and adverse event (AE)-associated tolerability of treatment with immunomodulators and biologics in ulcerative colitis clinical trials. We performed a literature search of PubMed and the Cochrane databases to identify randomized placebo-controlled trials of immunomodulators and biologics. Tolerability was defined through study withdrawal due to AEs and efficacy through clinical response in induction trials and clinical remission in maintenance trials. We performed meta-analyses using a random-effects model to determine relative risks (RRs) of efficacy and study withdrawal. Number needed to treat (NNT) and number needed to stop (NNS) were determined. The ratio of NNS/NNT was calculated, with a higher ratio indicating a greater number of patients in remission for every AE study discontinuation. We examined 13 single-agent trials representing biologics (infliximab, adalimumab, golimumab, and vedolizumab) and immunomodulators (tacrolimus and azathioprine). Induction therapy did not result in excess study withdrawal with immunomodulators (RR = 0.9, 95% CI 0.1-12.0) or biologics (RR = 0.7, 95% CI 0.3-1.8), therefore the NNS/NNT ratio could not be assessed because of high tolerability. Maintenance immunomodulator therapy resulted in a NNS of 14 (RR = 2.8, 95% CI 0.7-10.5) and NNS/NNT ratio of 2.4 in 2 trials. Biologics did not result in excess study withdrawal in maintenance (RR = 0.7, 95% CI 0.3-1.7) or combined induction-and-maintenance (RR = 0.6, 95% CI 0.4-1.0) trials. Biologics were not associated with a higher RR of study withdrawal due to AE than placebo. There were insufficient data to compare these results with immunomodulators.
Çokkültürlülük ve Yurtseverlik Bağlamında Azınlık Öğrencilerinin Tarih Dersleriyle İlgili Algıları
Directory of Open Access Journals (Sweden)
Fatih YAZICI
2015-10-01
Full Text Available Bu araştırmada, Türkiye’deki azınlık okullarına devam eden lise öğrencilerinin tarih dersleriyle ilgili görüşlerinin çokkültürlülük ve yurtseverlik bağlamında değerlendirilmesi amaçlanmıştır. Araştırmanın çalışma grubunu kasti örneklem yöntemiyle seçilen, İstanbul’un çeşitli ilçelerindeki azınlık okulunda öğrenim gören 199 öğrenci oluşturmaktadır. Bu çalışma grubundan veri toplamak amacıyla araştırmacılar tarafından geliştirilen Çokkültürlülük Tutum Ölçeği, Yurtseverlik Ölçeği ve tarih derslerini kendi kimlikleri açısından değerlendirmelerini amaçlayan bir anket uygulanmıştır. Verilerin analizinde aritmetik ortalama, standart sapma ve t-testi kullanılmıştır. Araştırmaya katılan öğrencilerin çoğunluğu tarih derslerinde kendi kültürel kimliklerinin yeterince yer bulamadığını, bu kimliklere yer veren bölümlerde ise ötekileştirici bir söylemin kullanıldığını belirtmişlerdir. Tarih dersleri, kültürel farklılığa sahip öğrenciler için bu şekliyle, yurtseverlik duygusu oluşturmanın uzağında kalmaktadır.Anahtar Kelimeler: Tarih Öğretimi, Çokkültürlülük, Yurtseverlik, Çokkültürlü Eğitim, Azınlık Okulları PERCEPTION of MINORITY STUDENTS about HISTORY LESSONS in the CONTEXT of MULTICULTURALISM and PATRIOTISMAbstract: The purpose of this study is to evaluate perceptions of students who attend minority school with respect to history lessons in the context of multiculturalism and patriotism in Turkey. The study group consists of intentionally chosen 199 students attending at different minority schools in Istanbul. Survey method was used in this study. The Multiculturalism Attitude Scale, Patriotism Scale and a questionnaire, developed by the researchers, examining cultural diversity in history lessons were used. In analyzing date, t- test, arithmetic mean and standard deviation were used. The findings of the study indicated
Chen, Yu-Pei; Lv, Jia-Wei; Liu, Xu; Zhang, Yuan; Guo, Ying; Lin, Ai-Hua; Sun, Ying; Mao, Yan-Ping; Ma, Jun
2017-01-01
In the war on cancer marked by personalized medicine, positron emission tomography (PET)-based theranostic strategy is playing an increasingly important role. Well-designed clinical trials are of great significance for validating the PET applications and ensuring evidence-based cancer care. This study aimed to provide a comprehensive landscape of the characteristics of PET clinical trials using the substantial resource of ClinicalTrials.gov database. We identified 25,599 oncology trials registered with ClinicalTrials.gov in the last ten-year period (October 2005-September 2015). They were systematically reviewed to validate classification into 519 PET trials and 25,080 other oncology trials used for comparison. We found that PET trials were predominantly phase 1-2 studies (86.2%) and were more likely to be single-arm (78.9% vs. 57.9%, P oncology trials. Furthermore, PET trials were small in scale, generally enrolling fewer than 100 participants (20.3% vs. 25.7% for other oncology trials, P = 0.014), which might be too small to detect a significant theranostic effect. The funding support from industry or National Institutes of Health shrunk over time (both decreased by about 5%), and PET trials were more likely to be conducted in only one region lacking international collaboration (97.0% vs. 89.3% for other oncology trials, P oncology are not receiving the attention or efforts necessary to generate high-quality evidence. Advancing the clinical application of PET imaging will require a concerted effort to improve the quality of trials. PMID:28042342
Employee-Driven Innovation: A Brave New World in the Build Environment’s Project Organisations
DEFF Research Database (Denmark)
Sørensen, Henrik; Wandahl, Søren
2013-01-01
-driven innovation (EDI) could be such a methodology to implicate the spoken and tacit knowledge of the employees that would strengthen the innovative capabilities of the project organisations. To investigate the theoretical field around EDI a literature study was conducted. The overall objective was to develop...... a theoretical framework based on the field of EDI and related methodologies. This research resulted in two main findings. First; identification of the overall themes of the EDI field of research. Second; definition of an overall framework of methodologies to conduct EDI in project organisations. Furthermore...
From Controlled Trial to Community Adoption: The Multisite Translational Community Trial
Murimi, Mary; Gonzalez, Anjelica; Njike, Valentine; Green, Lawrence W.
2011-01-01
Methods for translating the findings of controlled trials, such as the Diabetes Prevention Program, into real-world community application have not been clearly defined. A standardized research methodology for making and evaluating such a transition is needed. We introduce the multisite translational community trial (mTCT) as the research analog to the multisite randomized controlled trial. The mTCT is adapted to incorporate the principles and practices of community-based participatory research and the increased relevance and generalizability gained from diverse community settings. The mTCT is a tool designed to bridge the gap between what a clinical trial demonstrates can work in principle and what is needed to make it workable and effective in real-world settings. Its utility could be put to the test, in particular with practice-based research networks such as the Prevention Research Centers. PMID:21680935
Pradhan, M.; Brinkman, S.A.; Beatty, A.; Maika, A.; Satriawan, E.; de Ree, J.; Hasan, A.
2013-01-01
Background This paper presents the study protocol for a pragmatic cluster randomized controlled trial (RCT) with a supplementary matched control group. The aim of the trial is to evaluate a community-based early education and development program launched by the Government of Indonesia. The program
Pradhan, M.P.; Brinkman, S.A.; Beatty, A.; Maika, A.; Satriawan, E.; de Ree, J.; Hasan, A.
2013-01-01
Background: This paper presents the study protocol for a pragmatic cluster randomized controlled trial (RCT) with a supplementary matched control group. The aim of the trial is to evaluate a community-based early education and development program launched by the Government of Indonesia. The program
Nohavova, Iveta; Dogar, Omara; Kralikova, Eva; Pankova, Alexandra; Zvolska, Kamila; Huque, Rumana; Fatima, Razia; Noor, Maryam; Elsey, Helen; Sheikh, Aziz; Siddiqi, Kamran; Kotz, Daniel
2018-01-01
Introduction Tuberculosis (TB) remains a significant public health problem in South Asia. Tobacco use increases the risks of TB infection and TB progression. The TB& Tobacco placebo-controlled randomised trial aims to (1) assess the effectiveness of the tobacco cessation medication cytisine versus placebo when combined with behavioural support and (2) implement tobacco cessation medication and behavioural support as part of general TB care in Bangladesh and Pakistan. This paper summarises the process and context evaluation protocol embedded in the effectiveness–implementation hybrid design. Methods and analysis We are conducting a mixed-methods process and context evaluation informed by an intervention logic model that draws on the UK Medical Research Council’s Process Evaluation Guidance. Our approach includes quantitative and qualitative data collection on context, recruitment, reach, dose delivered, dose received and fidelity. Quantitative data include patient characteristics, reach of recruitment among eligible patients, routine trial data on dose delivered and dose received, and a COM-B (‘capability’, ‘opportunity’, ‘motivation’ and ‘behaviour’) questionnaire filled in by participating health workers. Qualitative data include semistructured interviews with TB health workers and patients, and with policy-makers at district and central levels in each country. Interviews will be analysed using the framework approach. The behavioural intervention delivery is audio recorded and assessed using a predefined fidelity coding index based on behavioural change technique taxonomy. Ethics and dissemination The study complies with the guidelines of the Declaration of Helsinki. Ethics approval for the study and process evaluation was granted by the University of Leeds (qualitative components), University of York (trial data and fidelity assessment), Bangladesh Medical Research Council and Bangladesh Drug Administration (trial data and qualitative
Biopharmaceutical industry-sponsored global clinical trials in emerging countries.
Alvarenga, Lenio Souza; Martins, Elisabeth Nogueira
2010-01-01
To evaluate biopharmaceutical industry-sponsored clinical trials placed in countries previously described as emerging regions for clinical research, and potential differences for those placed in Brazil. Data regarding recruitment of subjects for clinical trials were retrieved from www.clinicaltrials.gov on February 2nd 2009. Proportions of sites in each country were compared among emerging countries. Multiple logistic regressions were performed to evaluate whether trial placement in Brazil could be predicted by trial location in other countries and/or by trial features. A total of 8,501 trials were then active and 1,170 (13.8%) included sites in emerging countries (i.e., Argentina, Brazil, China, Czech Republic, Hungary, India, Mexico, Poland, Russia, South Korea, and South Africa). South Korea and China presented a significantly higher proportion of sites when compared to other countries (pattractiveness for biopharmaceutical industry-sponsored clinical trials.
Emaus, Marleen J; Bakker, Marije F; Beelen, Rob M J; Veldhuis, Wouter B; Peeters, Petra H M; van Gils, Carla H
2014-12-01
It has been observed that women living in urban areas have a higher mammographic density (MD) compared to women living in rural areas. This association might be explained by regional differences in reproductive and lifestyle factors or perhaps by variation in exposure to ambient air pollution as air pollution particles have been described to show estrogenic activity. We investigated the association between degree of urbanization and MD, and aimed to unravel the underlying etiology. 2,543 EPIC-NL participants were studied, and general linear models were used. Urbanization was categorized into five categories according to the number of addresses/km(2). Information on reproductive and lifestyle factors was obtained from the recruitment questionnaire. Air pollution exposure was estimated using land-use regression models. MD was expressed as percent density (PD) and dense area (DA), and was quantified using Cumulus. Women living in extremely urbanized areas had a higher PD (21.4%, 95% confidence interval (CI) 20.5-22.3%) compared to women living in not urbanized areas (16.1, 95% CI 14.5-17.8%, P trend air pollution (adjusted PDextremely_urbanized = 22.1%, 95% CI 18.0-26.5% versus adjusted PDnot_urbanized = 16.9%, 95% CI 13.0-21.2, P trend urbanization is associated with MD. The association could not be explained by differences in reproductive and lifestyle factors or by variation in air pollution exposure.
Directory of Open Access Journals (Sweden)
Yong Xu
2017-04-01
Full Text Available D-Xylonic acid belongs to the top 30 biomass-based platform chemicals and represents a promising application of xylose. Until today, Gluconobacter oxydans NL71 is the most efficient microbe capable of fermenting xylose into xylonate. However, its growth is seriously inhibited when concentrated lignocellulosic hydrolysates are used as substrates due to the presence of various degraded compounds formed during biomass pretreatment. Three critical lignocellulosic inhibitors were thereby identified, i.e., formic acid, furfural, and 4-hydroxybenzaldehyde. As microbe fermentation is mostly regulated at the genome level, four groups of cell transcriptomes were obtained for a comparative investigation by RNA sequencing of a control sample with samples treated separately with the above-mentioned inhibitors. The digital gene expression profiles screened 572, 714 genes, and 408 DEGs was obtained by the comparisons among four transcriptomes. A number of genes related to the different functional groups showed characteristic expression patterns induced by three inhibitors, in which 19 genes were further tested and confirmed by qRT-PCR. We extrapolated many differentially expressed genes that could explain the cellular responses to the inhibitory effects. We provide results that enable the scientific community to better define the molecular processes involved in the microbes' responses to lignocellulosic inhibitors during the cellular biooxidation of xylose into xylonic acid.
van Leeuwen, K.M.; Bosmans, J.E.; Jansen, A.P.D.; Hoogendijk, E.O.; Muntinga, M.E.; van Hout, H.P.J.; Nijpels, G.; van der Horst, H.E.; van Tulder, M.W.
2015-01-01
Objectives To evaluate the cost-effectiveness of the Geriatric Care Model (GCM), an integrated care model for frail older adults based on the Chronic Care Model, with that of usual care. Design Economic evaluation alongside a 24-month stepped-wedge cluster-randomized controlled trial. Setting
van Leeuwen, Karen M; Bosmans, Judith E; Jansen, Aaltje P D; Hoogendijk, Emiel O; Muntinga, Maaike E; van Hout, Hein P J; Nijpels, Giel; van der Horst, Henriette E; van Tulder, Maurits W
2015-01-01
OBJECTIVES: To evaluate the cost-effectiveness of the Geriatric Care Model (GCM), an integrated care model for frail older adults based on the Chronic Care Model, with that of usual care. DESIGN: Economic evaluation alongside a 24-month stepped-wedge cluster-randomized controlled trial. SETTING:
Spine device clinical trials: design and sponsorship.
Cher, Daniel J; Capobianco, Robyn A
2015-05-01
Multicenter prospective randomized clinical trials represent the best evidence to support the safety and effectiveness of medical devices. Industry sponsorship of multicenter clinical trials is purported to lead to bias. To determine what proportion of spine device-related trials are industry-sponsored and the effect of industry sponsorship on trial design. Analysis of data from a publicly available clinical trials database. Clinical trials of spine devices registered on ClinicalTrials.gov, a publicly accessible trial database, were evaluated in terms of design, number and location of study centers, and sample size. The relationship between trial design characteristics and study sponsorship was evaluated using logistic regression and general linear models. One thousand six hundred thrity-eight studies were retrieved from ClinicalTrials.gov using the search term "spine." Of the 367 trials that focused on spine surgery, 200 (54.5%) specifically studied devices for spine surgery and 167 (45.5%) focused on other issues related to spine surgery. Compared with nondevice trials, device trials were far more likely to be sponsored by the industry (74% vs. 22.2%, odds ratio (OR) 9.9 [95% confidence interval 6.1-16.3]). Industry-sponsored device trials were more likely multicenter (80% vs. 29%, OR 9.8 [4.8-21.1]) and had approximately four times as many participating study centers (pdevices not sponsored by the industry. Most device-related spine research is industry-sponsored. Multicenter trials are more likely to be industry-sponsored. These findings suggest that previously published studies showing larger effect sizes in industry-sponsored vs. nonindustry-sponsored studies may be biased as a result of failure to take into account the marked differences in design and purpose. Copyright © 2015 Elsevier Inc. All rights reserved.
Directory of Open Access Journals (Sweden)
Wouter van Ballegooijen
2016-10-01
Full Text Available Abstract Background Ecological momentary assessment (EMA of mental health symptoms may influence the symptoms that it measures, i.e. assessment reactivity. In the field of depression, EMA reactivity has received little attention. We aim to investigate whether EMA of depressive symptoms induces assessment reactivity. Reactivity will be operationalised as an effect of EMA on depressive symptoms measured by a retrospective questionnaire, and, secondly, as a change in response rate and variance of the EMA ratings. Methods This study is a 12-week randomised controlled trial comprising three groups: group 1 carries out EMA of mood and completes a retrospective questionnaire, group 2 carries out EMA of how energetic they feel and completes a retrospective questionnaire, group 3 is the control group, which completes only the retrospective questionnaire. The retrospective questionnaire (Centre for Epidemiologic Studies Depression scale; CES-D assesses depressive symptoms and is administered at baseline, 6 weeks after baseline and 12 weeks after baseline. We aim to recruit 160 participants who experience mild to moderate depressive symptoms, defined as a Patient Health Questionnaire (PHQ-9 score of 5 to 15. This study is powered to detect a small between-groups effect, where no clinically relevant effect is defined as the effect size margin −0.25< d <0.25. Discussion To our knowledge, this is the first study to investigate whether self-rated EMA of depressive symptoms could induce assessment reactivity among mildly depressed individuals. Trial registration Netherlands Trial Register NTR5803. Registered 12 April 2016. http://www.trialregister.nl/trialreg/admin/rctview.asp?TC=5803 .
Barr, Colin; Marois, Maria; Sim, Ida; Schmid, Christopher H; Wilsey, Barth; Ward, Deborah; Duan, Naihua; Hays, Ron D; Selsky, Joshua; Servadio, Joseph; Schwartz, Marc; Dsouza, Clyde; Dhammi, Navjot; Holt, Zachary; Baquero, Victor; MacDonald, Scott; Jerant, Anthony; Sprinkle, Ron; Kravitz, Richard L
2015-02-27
Chronic pain is prevalent, costly, and clinically vexatious. Clinicians typically use a trial-and-error approach to treatment selection. Repeated crossover trials in a single patient (n-of-1 trials) may provide greater therapeutic precision. N-of-1 trials are the most direct way to estimate individual treatment effects and are useful in comparing the effectiveness and toxicity of different analgesic regimens. The goal of the PREEMPT study is to test the 'Trialist' mobile health smartphone app, which has been developed to make n-of-1 trials easier to accomplish, and to provide patients and clinicians with tools for individualizing treatments for chronic pain. A randomized controlled trial is being conducted to test the feasibility and effectiveness of the Trialist app. A total of 244 participants will be randomized to either the Trialist app intervention group (122 patients) or a usual care control group (122 patients). Patients assigned to the Trialist app will work with their clinicians to set up an n-of-1 trial comparing two pain regimens, selected from a menu of flexible options. The Trialist app provides treatment reminders and collects data entered daily by the patient on pain levels and treatment side effects. Upon completion of the n-of-1 trial, patients review results with their clinicians and develop a long-term treatment plan. The primary study outcome (comparing Trialist to usual care patients) is pain-related interference with daily functioning at 26 weeks. Trialist will allow patients and clinicians to conduct personalized n-of-1 trials. In prior studies, n-of-1 trials have been shown to encourage greater patient involvement with care, which has in turn been associated with better health outcomes. mHealth technology implemented using smartphones may offer an efficient means of facilitating n-of-1 trials so that more patients can benefit from this approach. ClinicalTrials.gov: NCT02116621 , first registered 15 April 2014.
Directory of Open Access Journals (Sweden)
Moises A. Franco-Molina
2017-01-01
Full Text Available A controlled, parallel, randomized and comparative trial was carried out to evaluate the anti-inflammatory efficacy of IMMUNEPOTENT CRP versus ibuprofen in patients after third-molar surgery over seven days. The anti-inflammatory efficacy of IMMUNEPOTENT CRP was evaluated using the method of Amin and Laskin, and the analysis of cytokine production (IL-2, IL-4, IL-6, IL-10, TNF-α, INF-γ in saliva was done by flow cytometry. The swelling process after surgery was significant (p < 0.05 and the treatments with IMMUNEPOTENT CRP or ibuprofen controlled this process properly; no difference between the groups was found (p < 0.05. Both treatments were shown to modulate the cytokine production. These results demonstrate the anti-inflammatory activity of the natural compound IMMUNEPOTENT CRP and suggest it could be used in clinical dental practice.
Elias, Joëlle; van Dongen, Ivo M; Hoebers, Loes P; Ouweneel, Dagmar M; Claessen, Bimmer E P M; Råmunddal, Truls; Laanmets, Peep; Eriksen, Erlend; van der Schaaf, René J; Ioanes, Dan; Nijveldt, Robin; Tijssen, Jan G; Hirsch, Alexander; Henriques, José P S
2017-07-19
The Evaluating Xience and left ventricular function in PCI on occlusiOns afteR STEMI (EXPLORE) trial did not show a significant benefit of percutaneous coronary intervention (PCI) of the concurrent chronic total occlusion (CTO) in ST-segment elevation myocardial infarction (STEMI) patients on global left ventricular (LV) systolic function. However a possible treatment effect will be most pronounced in the CTO territory. Therefore, we aimed to study the effect of CTO PCI compared to no-CTO PCI on the recovery of regional LV function, particularly in the CTO territory. Using cardiovascular magnetic resonance (CMR) we studied 180 of the 302 EXPLORE patients with serial CMR (baseline and 4 months follow-up). Segmental wall thickening (SWT) was quantified on cine images by an independent core laboratory. Dysfunctional segments were defined as SWT PCI compared to no-CTO PCI (ΔSWT 17 ± 27% vs 11 ± 23%, p = 0.03). This recovery was most pronounced in the dysfunctional but viable segments(TEI PCI compared with no-CTO PCI is associated with a greater recovery of regional systolic function in the CTO territory, especially in the dysfunctional but viable segments. Further research is needed to evaluate the use of CMR in selecting post-STEMI patients for CTO PCI and the effect of regional LV function recovery on clinical outcome. Trialregister.nl NTR1108 , Date registered NTR: 30-okt-2007.
A data grid for imaging-based clinical trials
Zhou, Zheng; Chao, Sander S.; Lee, Jasper; Liu, Brent; Documet, Jorge; Huang, H. K.
2007-03-01
Clinical trials play a crucial role in testing new drugs or devices in modern medicine. Medical imaging has also become an important tool in clinical trials because images provide a unique and fast diagnosis with visual observation and quantitative assessment. A typical imaging-based clinical trial consists of: 1) A well-defined rigorous clinical trial protocol, 2) a radiology core that has a quality control mechanism, a biostatistics component, and a server for storing and distributing data and analysis results; and 3) many field sites that generate and send image studies to the radiology core. As the number of clinical trials increases, it becomes a challenge for a radiology core servicing multiple trials to have a server robust enough to administrate and quickly distribute information to participating radiologists/clinicians worldwide. The Data Grid can satisfy the aforementioned requirements of imaging based clinical trials. In this paper, we present a Data Grid architecture for imaging-based clinical trials. A Data Grid prototype has been implemented in the Image Processing and Informatics (IPI) Laboratory at the University of Southern California to test and evaluate performance in storing trial images and analysis results for a clinical trial. The implementation methodology and evaluation protocol of the Data Grid are presented.
Cano, Stefan J; Posner, Holly B; Moline, Margaret L; Hurt, Stephen W; Swartz, Jina; Hsu, Tim; Hobart, Jeremy C
2010-12-01
The Alzheimer's Disease Assessment Scale Cognitive Behavior Section (ADAS-cog), a measure of cognitive performance, has been used widely in Alzheimer's disease trials. Its key role in clinical trials should be supported by evidence that it is both clinically meaningful and scientifically sound. Its conceptual and neuropsychological underpinnings are well-considered, but its performance as an instrument of measurement has received less attention. Objective To examine the traditional psychometric properties of the ADAS-cog in a large sample of people with Alzheimer's disease. Data from three clinical trials of donepezil (Aricept) in mild-to-moderate Alzheimer's disease (n=1421; MMSE 10-26) were analysed at both the scale and component level. Five psychometric properties were examined using traditional psychometric methods. These methods of examination underpin upcoming Food and Drug Administration recommendations for patient rating scale evaluation. At the scale-level, criteria tested for data completeness, scaling assumptions (eg, component total correlations: 0.39-0.67), targeting (no floor or ceiling effects), reliability (eg, Cronbach's α: = 0.84; test-retest intraclass correlations: 0.93) and validity (correlation with MMSE: -0.63) were satisfied. At the component level, 7 of 11 ADAS-cog components had substantial ceiling effects (range 40-64%). Performance was satisfactory at the scale level, but most ADAS-cog components were too easy for many patients in this sample and did not reflect the expected depth and range of cognitive performance. The clinical implication of this finding is that the ADAS-cog's estimate of cognitive ability, and its potential ability to detect differences in cognitive performance under treatment, could be improved. However, because of the limitations of traditional psychometric methods, further evaluations would be desirable using additional rating scale analysis techniques to pinpoint specific improvements.
Clinical trials in dentistry in India: Analysis from trial registry.
Gowri, S; Kannan, Sridharan
2017-01-01
Evidence-based practice requires clinical trials to be performed. In India, if any clinical trial has to be performed, it has to be registered with clinical trial registry of India. Studies have shown that the report of clinical trials is poor in dentistry. Hence, the present study has been conducted to assess the type and trends of clinical trials being undertaken in dentistry in India over a span of 6 years. All the clinical trials which were registered with the Central Trial Registry of India (CTRI) (www.ctri.nic.in) from January 1, 2007 to March 3, 2014 were evaluated using the keyword "dental." Following information were collected for each of the clinical trials obtained from the search; number of centres (single center/multicentric), type of the institution undertaking the research (government/private/combined), study (observational/interventional), study design (randomized/single blinded/double-blinded), type of health condition, type of participants (healthy/patients), sponsors (academia/commercial), phase of clinical trial (Phase 1/2/3/4), publication details (published/not published), whether it was a postgraduate thesis or not and prospective or retrospective registration of clinical trials, methodological quality (method of randomization, allocation concealment). Descriptive statistics was used for analysis of various categories. Trend analysis was done to assess the changes over a period of time. The search yielded a total of 84 trials of which majority of them were single centered. Considering the study design more than half of the registered clinical trials were double-blinded (47/84 [56%]). With regard to the place of conducting a trial, most of the trials were planned to be performed in private hospitals (56/84 [66.7%]). Most (79/84, 94.1%) of the clinical trials were interventional while only 5/84 (5.9%) were observational. Majority (65/84, 77.4%) of the registered clinical trials were recruiting patients while the rest were being done in healthy
Koning, Mark V; Teunissen, Aart Jan W; van der Harst, Erwin; Ruijgrok, Elisabeth J; Stolker, Robert Jan
2018-02-01
Management of postoperative pain after laparoscopic segmental colonic resections remains controversial. We compared 2 methods of analgesia within an Enhanced Recovery After Surgery (ERAS) program. The goal of the study was to investigate whether administration of intrathecal bupivacaine/morphine would lead to an enhanced recovery. A single-center, randomized, double-blind controlled trial was performed (NL43488.101.13). Patients scheduled for laparoscopic segmental intestinal resections were considered. Exclusion criteria were patients in whom contraindications to spinal anesthesia were present, conversion to open surgery, and gastric and rectal surgery. The intervention group received single-shot intrathecal bupivacaine/morphine (12.5 mg/300 μg), with an altered dose for older patients. The control group received a sham procedure and a bolus of piritramide (0.1 mg/kg). Both groups received standardized general anesthesia and a patient-controlled intravenous analgesia pump as postoperative analgesia. All patients were treated according to an ERAS protocol. A decrease in days to "fit for discharge" was the primary outcome. Fifty-six patients were enrolled. Intervention group patients were fit for discharge earlier (median of 3 vs 4 days, P = 0.044). Furthermore, there was a significant decrease in opioid use and lower pain scores on the first postoperative day in the intervention group. There were no differences in adverse events (except for more pruritus), time to mobilization, fluid administration, or patient satisfaction. This randomized controlled trial shows that intrathecal morphine is a more effective method of postoperative analgesia in laparoscopic surgery than intravenous opioids within an ERAS program. Recovery is faster and less painful with intrathecal morphine. Other studies have confirmed these results, although data on faster recovery are new and require confirmation in future trials. This study was registered at ClinicalTrials.gov, identifier NCT
Energy Technology Data Exchange (ETDEWEB)
Biemont, E. [Institut de Physique Nucleaire Experimentale, Universite de Liege, B-4000 Liege (Belgium); Universite de Mons-Hainaut, B-7000 Mons (Belgium). E-mail: e.biemont at ulg.ac.be; Magunov, A.I.; Dyakin, V.M.; Faenov, A.Y.; Pikuz, T.A.; Skobelev, I.Y. [Multicharged Ions Spectra Data Center of VNIIFTRI, Mendeleevo, 141570 Moscow region (Russian Federation); Osterheld, A.L.; Goldstein, W.H. [Lawrence Livermore National Laboratory, Livermore, CA 94550 (United States); Flora, F.; DiLazzaro, P.; Bollanti, S.; Lisi, N.; Letardi, T. [ENEA, Frascati Center, Department of Innovation Technologies, Frascati (Italy); Reale, A.; Palladino, L. [Dip. Fisica Universita dell' Aquila e INFN, g.c. LNGS, L' Aquila (Italy); Batani, D.; Mauri, A. [Dip. di Fisica Universita di Milano e INFN, Sezione di Milano (Italy); Scafati, A.; Reale, L. [Lab. di Fisica, Instituto Superiore di Sanita e INFN, Rome (Italy)
2000-06-14
The wavelengths of the 2l-nl' (n=4-15) spectral lines of Ne-like Ni XIX and Ge XXIII were measured in laser-produced plasmas. The accuracy of these measurements (0.5-2.5 mA) is a large improvement over previous results, and a number of transitions (mainly from levels with n=8-15) were observed for the first time. The 2p{sub 3/2}-nd{sub 5/2} and 2p{sub 1/2}-nd{sub 3/2} Rydberg series were used to determine the first two ionization limits of the ground states of Ni XIX and Ge XXIII. Effects of configuration interaction were observed in the intensities of some spectral lines. (author)
Tolley, Elizabeth E; Guthrie, Kate Morrow; Zissette, Seth; Fava, Joseph L; Gill, Katherine; Louw, Cheryl E; Kotze, Philip; Reddy, Krishnaveni; MacQueen, Kathleen
2018-01-01
Low adherence in recent HIV prevention clinical trials highlights the need to better understand, measure, and support product use within clinical trials. Conventional self-reported adherence instruments within HIV prevention trials, often relying on single-item questions, have proven ineffective. While objective adherence measures are desirable, none currently exist that apply to both active and placebo arms. Scales are composed of multiple items in the form of questions or statements that, when combined, measure a more complex construct that may not be directly observable. When psychometrically validated, such measures may better assess the multiple factors contributing to adherence/non-adherence. This study aimed to develop and psychometrically evaluate tools to screen and monitor trial participants' adherence to HIV prevention products within the context of clinical trial research. Based on an extensive literature review and conceptual framework, we identified and refined 86 items assessing potential predictors of adherence and 48 items assessing adherence experience. A structured survey, including adherence items and other variables, was administered to former ASPIRE and Ring Study participants and similar non-trial participants (n = 709). We conducted exploratory factor analyses (EFA) to identify a reduced set of constructs and items that could be used at screening to predict potential adherence, and at follow-up to monitor and intervene on adherence. We examined associations with other variables to assess content and construct validity. The EFA of screener items resulted in a 6-factor solution with acceptable to very good internal reliability (α: .62-.84). Similar to our conceptual framework, factors represent trial-related commitment (Distrust of Research and Commitment to Research); alignment with trial requirements (Visit Adherence and Trial Incompatibility); Belief in Trial Benefits and Partner Disclosure. The EFA on monitoring items resulted in 4
Full Text Available ... Wide Range of Audiences The Children and Clinical Studies Program has been successfully developed and evaluated to fill an important gap in information and education for parents, clinicians, researchers, children, and the general public. What to Expect During a clinical trial, doctors, ...
Improved Endpoints for Cancer Immunotherapy Trials
Eggermont, Alexander M. M.; Janetzki, Sylvia; Hodi, F. Stephen; Ibrahim, Ramy; Anderson, Aparna; Humphrey, Rachel; Blumenstein, Brent; Wolchok, Jedd
2010-01-01
Unlike chemotherapy, which acts directly on the tumor, cancer immunotherapies exert their effects on the immune system and demonstrate new kinetics that involve building a cellular immune response, followed by changes in tumor burden or patient survival. Thus, adequate design and evaluation of some immunotherapy clinical trials require a new development paradigm that includes reconsideration of established endpoints. Between 2004 and 2009, several initiatives facilitated by the Cancer Immunotherapy Consortium of the Cancer Research Institute and partner organizations systematically evaluated an immunotherapy-focused clinical development paradigm and created the principles for redefining trial endpoints. On this basis, a body of clinical and laboratory data was generated that supports three novel endpoint recommendations. First, cellular immune response assays generate highly variable results. Assay harmonization in multicenter trials may minimize variability and help to establish cellular immune response as a reproducible biomarker, thus allowing investigation of its relationship with clinical outcomes. Second, immunotherapy may induce novel patterns of antitumor response not captured by Response Evaluation Criteria in Solid Tumors or World Health Organization criteria. New immune-related response criteria were defined to more comprehensively capture all response patterns. Third, delayed separation of Kaplan–Meier curves in randomized immunotherapy trials can affect results. Altered statistical models describing hazard ratios as a function of time and recognizing differences before and after separation of curves may allow improved planning of phase III trials. These recommendations may improve our tools for cancer immunotherapy trials and may offer a more realistic and useful model for clinical investigation. PMID:20826737
Employee-driven innovation in large project organisations
DEFF Research Database (Denmark)
Sørensen, Henrik; Wandahl, Søren; Christensen, Randi Muff
2014-01-01
(EDI). The case was a group of employees in a large governmental client organisation. The EDI framework was based on a theoretical approach to conduct EDI, derived from a previous literature study. The case study was conducted as an exploratory case study with outset in a gaming approach...... that challenged the participants with discussions on obstacles and solutions for EDI. The game approach was undertaken to facilitate discussions on specific EDI topics carefully selected to stimulate both group and plenum discussions. The themes of the theoretical framework were challenged through...... the participants’ discussions and perceptions of the applicability in the organisation. The findings were discussed in relation to the theoretical approach and findings from a comparable case study. It identified overall methods that had the higher robustness and applicability to incorporate in a practical EDI...
Pereira, Renata Venise Vargas
2013-01-01
Este trabalho teve como proposta investigar como as alterações na cena de apresentação do telejornal, que incluem a retirada da bancada como o principal elemento cênico e a circulação e posicionamento do apresentador no estúdio, constituem tentativas de aproximação com o telespectador, estabelecer vínculos de pertencimento e relações identitárias com seu público. Na pesquisa empírica avaliou-se as alterações adotadas pelo MGTV 1ª Edição, veiculado pela TV Integração de Juiz de Fora, emissora ...
Which dressing do donor site wounds need?: study protocol for a randomized controlled trial
Directory of Open Access Journals (Sweden)
Ubbink Dirk T
2011-10-01
patients. Thus, we aim to contribute a well-designed trial, relevant to all clinicians involved in the care for donor site wounds, which will help enhance uniformity and quality of care for these patients. Trial registration http://www.trialregister.nl, NTR1849. Date registered: June 9, 2009
No short-cut in assessing trial quality: a case study
Directory of Open Access Journals (Sweden)
Hirji Karim F
2009-01-01
Full Text Available Abstract Background Assessing the quality of included trials is a central part of a systematic review. Many check-list type of instruments for doing this exist. Using a trial of antibiotic treatment for acute otitis media, Burke et al., BMJ, 1991, as the case study, this paper illustrates some limitations of the check-list approach to trial quality assessment. Results The general verdict from the check list type evaluations in nine relevant systematic reviews was that Burke et al. (1991 is a good quality trial. All relevant meta-analyses extensively used its data to formulate therapeutic evidence. My comprehensive evaluation, on the other hand, brought to the surface a series of serious problems in the design, conduct, analysis and report of this trial that were missed by the earlier evaluations. Conclusion A check-list or instrument based approach, if used as a short-cut, may at times rate deeply flawed trials as good quality trials. Check lists are crucial but they need to be augmented with an in-depth review, and where possible, a scrutiny of the protocol, trial records, and original data. The extent and severity of the problems I uncovered for this particular trial warrant an independent audit before it is included in a systematic review.
Brusco, Natasha Kareem; Taylor, Nicholas F; Watts, Jennifer J; Shields, Nora
2014-01-01
To report if there is a difference in costs from a societal perspective between adults receiving rehabilitation in an inpatient rehabilitation setting versus an alternative setting. If there are cost differences, to report whether opting for the least expensive program setting adversely affects patient outcomes. Electronic databases from the earliest possible date until May 2011. All languages were included. Multiple reviewers identified randomized controlled trials with a full economic evaluation that compared adult inpatient rehabilitation with an alternative. There were 29 included trials with 6746 participants. Multiple observers extracted data independently. Trial appraisal included a risk of bias assessment and a checklist to report the strength of the economic evaluation. Results were synthesized using standardized mean differences (SMDs) and meta-analyses for the primary outcome of cost. The Grading of Recommendations Assessment, Development, and Evaluation was applied to assess for risk of bias across studies for meta-analyses. There was high-quality evidence that cost was significantly reduced for rehabilitation in the home versus inpatient rehabilitation in a meta-analysis of 732 patients poststroke (pooled SMD [δ]=-.28; 95% confidence interval [CI], -.47 to -.09), without compromise to patient outcomes. Results of individual trials in other patient groups (orthopedic, rheumatoid arthritis, and geriatric) receiving rehabilitation in the home or community were generally consistent with the meta-analysis. There was moderate quality evidence that cost was significantly reduced for inpatient rehabilitation (stroke unit) versus general acute care in a meta-analysis of 463 patients poststroke (δ=.31; 95% CI, .15-.48), with improvement to patient outcomes. These results were not replicated in 2 individual trials with a geriatric and a mixed cohort, where costs did not differ between general acute care and inpatient rehabilitation. Three of the 4 individual
Directory of Open Access Journals (Sweden)
Feder Gene
2010-01-01
Full Text Available Abstract Background Intimate partner abuse (IPA is a major public health problem with serious implications for the physical and psychosocial wellbeing of women, particularly women of child-bearing age. It is a common, hidden problem in general practice and has been under-researched in this setting. Opportunities for early intervention and support in primary care need to be investigated given the frequency of contact women have with general practice. Despite the high prevalence and health consequences of abuse, there is insufficient evidence for screening in primary care settings. Furthermore, there is little rigorous evidence to guide general practitioners (GPs in responding to women identified as experiencing partner abuse. This paper describes the design of a trial of a general practice-based intervention consisting of screening for fear of partner with feedback to GPs, training for GPs, brief counselling for women and minimal practice organisational change. It examines the effect on women's quality of life, mental health and safety behaviours. Methods/Design weave is a cluster randomised controlled trial involving 40 general practices in Victoria, Australia. Approximately 500 women (16-50 years seen by the GP in the previous year are mailed a short lifestyle survey containing an item to screen for IPA. Women who indicate that they were afraid of a partner/ex-partner in the last year and provide contact details are invited to participate. Once baseline data are collected, GPs are randomly assigned to either a group involving healthy relationship and responding to IPA training plus inviting women for up to 6 sessions of counselling or to a group involving basic education and usual care for women. Outcomes will be evaluated by postal survey at 6 and 12 months following delivery of the intervention. There will be an economic evaluation, and process evaluation involving interviews with women and GPs, to inform understanding about implementation
van Engelenburg-van Lonkhuyzen, Marieke L; Bols, Esther M J; Benninga, Marc A; Verwijs, Wim A; Bluijssen, Netty M W L; de Bie, Rob A
2013-08-02
Functional constipation is a common disorder worldwide and is found in all paediatric age groups. Functional constipation can be caused by delayed colonic transit or dysfunction of the pelvic floor muscles. Standard medical care in paediatric practice is often based on clinical experience and mainly consists of a behavioural approach and toilet training, along with the prescription of laxatives. Evidence to evaluate the effectiveness of pelvic physiotherapy for this complaint is lacking. A two-armed multicentre randomised controlled trial has been designed. We hypothesise that the combination of pelvic physiotherapy and standard medical care will be more effective than standard medical care alone for constipated children, aged 5 to 17 years. Children with functional constipation according to the Rome III will be included. Web-based baseline and follow-up measurements, scheduled at 3 and 6 months after inclusion, consist of the numeric rating scale in relation to the perceived severity of the problem, the Strength and Difficulties Questionnaire and subjective improvement post-intervention (global perceived effect). Examination of the pelvic floor muscle functions, including digital testing and biofeedback, will take place during baseline and follow-up measurements at the physiotherapist. The control group will only receive standard medical care, involving at least three contacts during five months, whereas the experimental group will receive standard medical care plus pelvic physiotherapy, with a maximum of six contacts. The physiotherapy intervention will include standard medical care, pelvic floor muscle training, attention to breathing, relaxation and awareness of body and posture. The study duration will be six months from randomisation, with a three-year recruitment period. The primary outcome is the absence of functional constipation according to the Rome III criteria. This section discusses the relevance of publishing the study design and the development of
Directory of Open Access Journals (Sweden)
Kari Ebbesen Karlsen
2018-01-01
Full Text Available Aim of the Study: The aim of this study is to examine the effect of yoga treatment of eating disorders (EDs. Methods: Adult females meeting the Diagnostic and Statistical Manual-IV criteria for bulimia nervosa or ED not otherwise specified (n = 30 were randomized to 11-week yoga intervention group (2 × 90 min/week or a control group. Outcome measures, the Eating Disorder Examination (EDE-Interview and Eating Disorders Inventory-2 (EDI-2 scores, were administered at baseline, posttest, and at 6-month follow-up. There was a dropout rate of 30% (posttest and 37% (6-month follow-up. Results: The intervention group showed reductions in EDE global score (P < 0.01, the EDE subscale restraint (P < 0.05, and eating concern (P < 0.01 compared to the control group. The differences between the groups increased at 6-month follow-up. There were no differences between the groups in the EDI-2 score. Conclusion: The results indicate that yoga could be effective in the treatment of ED.
Weiss, Laura A; Westerhof, Gerben J; Bohlmeijer, Ernst T
2013-09-20
psychology will be tackled with this study, such as having a target group who is especially vulnerable for low well-being. The practice-based setting is especially interesting, as it can give valuable insights in how positive psychology interventions work in practice, but can also give rise to several challenges. Dutch Trial Register, trial registration number TC=3377NTR.http://www.trialregister.nl/trialreg/admin/rctview.asp?TC=3377.
Lv, Xu-Cong; Jiang, Ya-Jun; Liu, Jie; Guo, Wei-Ling; Liu, Zhi-Bin; Zhang, Wen; Rao, Ping-Fan; Ni, Li
2017-08-16
Denaturing gradient gel electrophoresis (DGGE) has become a widely used tool to examine microbial community structure. However, when DGGE is applied to evaluate the fungal community of traditional fermentation starters, the choice of hypervariable ribosomal RNA gene regions is still controversial. In the current study, several previously published fungal PCR primer sets were compared and evaluated using PCR-DGGE, with the purpose of screening a suitable primer set to study the fungal community of traditional fermentation starters for Hong Qu glutinous rice wine. Firstly, different primer sets were used to amplify different hypervariable regions from pure fungal cultures. Except NS1/FR1+ and ITS1fGC/ITS4, other primer sets (NL1+/LS2R, NL3A/NL4GC, FF390/FR1+, NS1/GCFung, NS3+/YM951r and ITS1fGC/ITS2r) amplified the target DNA sequences successfully. Secondly, the selected primer sets were further evaluated based on their resolution to distinguish different fungal cultures through DGGE fingerprints. Three primer sets (NL1+/LS2R, NS1/GCFung and ITS1fGC/ITS2r) were finally selected for investigating the fungal community structure of different traditional fermentation starters for Hong Qu glutinous rice wine. The internal transcribed spacer (ITS) region amplified by ITS1fGC/ITS2r, which is more hypervariable than the 18S rRNA gene and 26S rRNA gene, provides an excellent tool to separate amplification products of different fungal species. Results indicated that PCR-DGGE profile using ITS1fGC/ITS2r showed more abundant fungal species than that using NL1+/LS2R and NS1/GCFung. Therefore, ITS1fGC/ITS2r is the most suitable primer set for PCR-DGGE analysis of fungal community structure in traditional fermentation starters for Hong Qu glutinous rice wine. DGGE profiles based on ITS1fGC/ITS2r revealed the presence of twenty-four fungal species in traditional fermentation starter. A significant difference of fungal community can be observed directly from DGGE fingerprints and
Geense, Wytske W; van Gaal, Betsie Gi; Knoll, Jacqueline L; Cornelissen, Elisabeth Am; Schoonhoven, Lisette; Kok, Gerjo
2016-01-13
The care for children with a chronic kidney disease (CKD) is complex. Parents of these children may experience high levels of stress in managing their child's disease, potentially leading to negative effects on their child's health outcomes. Although the experienced problems are well known, adequate (online) support for these parents is lacking. The objective of the study is to describe the systematic development of an online support program for parents of children with CKD, and how this program will be evaluated. Intervention Mapping (IM) was used for the development of the program. After conducting a needs assessment, defining program objectives, searching for theories, and selecting practical applications, the online program e-Powered Parents was developed. e-Powered Parents consist of three parts: (1) an informative part with information about CKD and treatments, (2) an interactive part where parents can communicate with other parents and health care professionals by chat, private messages, and a forum, and (3) a training platform consisting of four modules: Managing stress, Setting limits, Communication, and Coping with emotions. In a feasibility study, the potential effectiveness and effect size of e-Powered Parents will be evaluated using an explorative randomized controlled trial with parents of 120 families. The outcomes will be the child's quality of life, parental stress and fatigue, self-efficacy in the communication with health care professionals, and family management. A process evaluation will provide insight in parents' experiences, including their experienced level of support. Study results are expected to be published in the summer of 2016. Although the development of e-Powered Parents using IM was time-consuming, IM has been a useful protocol. IM provided us with a systematic framework for structuring the development process. The participatory planning group was valuable as well; knowledge, experiences, and visions were shared, ensuring us that
Lambeek, Ludeke C; Bosmans, Judith E; Van Royen, Barend J; Van Tulder, Maurits W; Van Mechelen, Willem; Anema, Johannes R
2010-01-01
Objective To evaluate the cost effectiveness, cost utility, and cost-benefit of an integrated care programme compared with usual care for sick listed patients with chronic low back pain. Design Economic evaluation alongside a randomised controlled trial with 12 months? follow-up. Setting Primary care (10 physiotherapy practices, one occupational health service, one occupational therapy practice) and secondary care (five hospitals) in the Netherlands, 2005-9. Participants 134 adults aged 18-65...
Miller, Sarah; Connolly, Paul
2013-01-01
Tutoring is commonly employed to prevent early reading failure, and evidence suggests that it can have a positive effect. This article presents findings from a large-scale ("n" = 734) randomized controlled trial evaluation of the effect of "Time to Read"--a volunteer tutoring program aimed at children aged 8 to 9 years--on…
Rebergen, David S.; Bruinvels, David J.; Bos, Chris M.; van der Beek, Allard J.; van Mechelen, Willem
2010-01-01
The aim of this study was to examine the adherence of occupational physicians (OP) to the Dutch guideline on the management of common mental health problems and its effect on return to work as part of the process evaluation of a trial comparing adherence to the guideline to care as usual. The first
Directory of Open Access Journals (Sweden)
Schroeder John S
2000-08-01
Full Text Available Synopsis Background Direct myocardial cell protection in patients with unstable angina or evolving myocardial infarction (MI could prevent cell necrosis or reduce its extent, and minimize the risk of MI and death associated with percutaneous coronary interventions (PCIs and coronary artery bypass surgery. The myocardial NHE plays a critical role in mediating the progression of ischemia to necrosis by promoting intracellular accumulation of sodium and calcium in exchange for hydrogen. Blockage of the system in various experimental models of ischemia and reperfusion had a strong antinecrotic effect. The present paper describes a trial that was intended to investigate the potential clinical benefit of cariporide, a potent and selective inhibitor of the NHE, in a large spectrum of at-risk patients. Trial design The GUARDIAN trial was a multicenter, double-blind, randomized, four-arm trial that compared three cariporide dosages with placebo in patients with unstable angina and non-ST-segment elevation myocardial infarction (UA/NSTEMI and in patients undergoing a high-risk PCI or coronary artery bypass surgery. A total of 11 590 patients with one of the three possible entry diagnoses were enroled in 23 countries. The trial was designed as a combined phase 2/phase 3 study. The primary objective was to evaluate the efficacy of cariporide in reducing all-cause mortality and/or MI across the various entry populations 36 days after randomization. Three different doses of cariporide were compared with placebo. Secondary end-points were death or non-fatal MI at 10 days and 6 months, and cardiac events related to left ventricular dysfunction. The extent of MI was also assessed by peak elevation in creatinine kinase (CK-MB and a ratio of peak elevation to normal values. The sample size was driven by a total event rate of 1200 patients experiencing a primary end-point, powered to detect a 25% risk reduction in any of the three treatment groups compared with
Classroom Application of a Trial-Based Functional Analysis
Bloom, Sarah E.; Iwata, Brian A.; Fritz, Jennifer N.; Roscoe, Eileen M.; Carreau, Abbey B.
2011-01-01
We evaluated a trial-based approach to conducting functional analyses in classroom settings. Ten students referred for problem behavior were exposed to a series of assessment trials, which were interspersed among classroom activities throughout the day. Results of these trial-based functional analyses were compared to those of more traditional…
Zhang, Kevin; Demner-Fushman, Dina
2017-07-01
To develop automated classification methods for eligibility criteria in ClinicalTrials.gov to facilitate patient-trial matching for specific populations such as persons living with HIV or pregnant women. We annotated 891 interventional cancer trials from ClinicalTrials.gov based on their eligibility for human immunodeficiency virus (HIV)-positive patients using their eligibility criteria. These annotations were used to develop classifiers based on regular expressions and machine learning (ML). After evaluating classification of cancer trials for eligibility of HIV-positive patients, we sought to evaluate the generalizability of our approach to more general diseases and conditions. We annotated the eligibility criteria for 1570 of the most recent interventional trials from ClinicalTrials.gov for HIV-positive and pregnancy eligibility, and the classifiers were retrained and reevaluated using these data. On the cancer-HIV dataset, the baseline regex model, the bag-of-words ML classifier, and the ML classifier with named entity recognition (NER) achieved macro-averaged F2 scores of 0.77, 0.87, and 0.87, respectively; the addition of NER did not result in a significant performance improvement. On the general dataset, ML + NER achieved macro-averaged F2 scores of 0.91 and 0.85 for HIV and pregnancy, respectively. The eligibility status of specific patient populations, such as persons living with HIV and pregnant women, for clinical trials is of interest to both patients and clinicians. We show that it is feasible to develop a high-performing, automated trial classification system for eligibility status that can be integrated into consumer-facing search engines as well as patient-trial matching systems. Published by Oxford University Press on behalf of the American Medical Informatics Association 2017. This work is written by US Government employees and is in the public domain in the US.
Rapport, Frances; Clement, Clare
2013-01-01
BackgroundQualitative research methods are increasingly used within trials to address broader research questions than quantitative methods can address alone. Qualitative methods enable health professionals, service users and other stakeholders to contribute their views and experiences when evaluating health care treatments, interventions or policies. They can influence trial design, allowing for a fuller engagement with research questions, aims and objectives and clarify the complexities of p...
Cambon, L; Bergman, P; Le Faou, Al; Vincent, I; Le Maitre, B; Pasquereau, A; Arwidson, P; Thomas, D; Alla, F
2017-01-01
Introduction A French national smoking cessation service, Tabac Info Service, has been developed to provide an adapted quitline and a web and mobile application involving personalised contacts (eg, questionnaires, advice, activities, messages) to support smoking cessation. This paper presents the study protocol of the evaluation of the application (e-intervention Tabac Info Service (e-TIS)). The primary objective is to assess the efficacy of e-TIS. The secondary objectives are to (1) describe efficacy variations with regard to users' characteristics, (2) analyse mechanisms and contextual conditions of e-TIS efficacy. Methods and analyses The study design is a two-arm pragmatic randomised controlled trial including a process evaluation with at least 3000 participants randomised to the intervention or to the control arm (current practices). Inclusion criteria are: aged 18 years or over, current smoker, having completed the online consent forms, possessing a mobile phone with android or apple systems and using mobile applications, wanting to stop smoking sooner or later. The primary outcome is the point prevalence abstinence of 7 days at 6 months later. Data will be analysed in intention to treat (primary) and per protocol analyses. A logistic regression will be carried out to estimate an OR (95% CI) for efficacy. A multivariate multilevel analysis will explore the influence on results of patients' characteristics (sex, age, education and socioprofessional levels, dependency, motivation, quit experiences) and contextual factors, conditions of use, behaviour change techniques. Ethics and dissemination The study protocol was reviewed by the ethical and deontological institutional review board of the French Institute for Public Health Surveillance on 18 April 2016. The findings of this study will allow us to characterise the efficacy of e-TIS and conditions of its efficacy. These findings will be disseminated through peer-reviewed articles. Trial registration
Pesola, Francesca; Williams, Julie; Bird, Victoria; Freidl, Marion; Le Boutillier, Clair; Leamy, Mary; Macpherson, Rob; Slade, Mike
2015-12-01
Pre-defined, researcher-selected outcomes are routinely used as the clinical end-point in randomized controlled trials (RCTs); however, individualized approaches may be an effective way to assess outcome in mental health research. The present study describes the development and evaluation of the Individualized Outcome Measure (IOM), which is a patient-specific outcome measure to be used for RCTs of complex interventions. IOM was developed using a narrative review, expert consultation and piloting with mental health service users (n = 20). The final version of IOM comprises two components: Goal Attainment (GA) and Personalized Primary Outcome (PPO). For GA, patients identify one relevant goal at baseline and rate its attainment at follow-up. For PPO, patients choose an outcome domain related to their goal from a pre-defined list at baseline, and complete a standardized questionnaire assessing the chosen outcome domain at baseline and follow-up. A feasibility study indicated that IOM had adequate completion (89%) and acceptability (96%) rates in a clinical sample (n = 84). IOM was then evaluated in a RCT (ISRCTN02507940). GA and PPO components were associated with each other and with the trial primary outcome. The use of the PPO component of IOM as the primary outcome could be considered in future RCTs. Copyright © 2015 John Wiley & Sons, Ltd. Copyright © 2015 John Wiley & Sons, Ltd.
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Luciana dos Santos Almeida
2016-06-01
Full Text Available For some time, Brazil has been appointed as one of the greatest consumers of cosmetic products in the world. Although cosmetics may seem harmless, destined exclusively to enhance personal appearance or to clean and protect the skin, hair and nails, new studies and events are highlighting the need to evaluate the safety of such products. The present work interrelated the lifecycle of a cosmetic product with the safety trials and tests applicable to some cycle phases. From this information, a survey was made of accredited Conformity Assessment Bodies (CAB and test facilities recognized by the General Coordination for Accreditation (CGCRE which are competent respectively to carry out safety trials and tests of cosmetics. Twenty five competent laboratories were identified to carry out chemical and/or biological trials of cosmetics, according to the legislation ABNT ISO IEC 17025:2005, and 10 test facilities recognized by the Compliance Monitoring Program that can carry out tests of the development of a product for register purposes, aiming at human health and safety. It is interesting to notice that Brazil has accredited laboratories to carry out trials that are critical for the health of the population, such as the levels of heavy metals and the presence of pathogens. On the other hand, CGCRE does not have a program to recognize safety clinical trials. The importance of this kind of study is understood, considering the world history of adverse reactions and the great consumption of cosmetics in the country.
Electronic data interchange in the Canadian natural gas industry
International Nuclear Information System (INIS)
Sheinfield, J.
1995-01-01
The concept of electronic data interchange (EDI) in the gas industry was discussed. EDI as a champion of costumer service and as a powerful management tool was defined, and the process of electronic information transfer was explained. EDI was then placed in the context of the business process, and its benefits in providing efficient service and product improvement were enumerated. North American Gas EDI standards, and industry initiatives were explored in detail
Meinecke, Anna Katharina; Welsing, Paco; Kafatos, George; Burke, Des; Trelle, Sven; Kubin, Maria; Nachbaur, Gaelle; Egger, Matthias; Zuidgeest, Mira
2017-01-01
Pragmatic trials can improve our understanding of how treatments will perform in routine practice. In a series of eight papers, the GetReal Consortium has evaluated the challenges in designing and conducting pragmatic trials and their specific methodological, operational, regulatory and ethical
Christian, Meaghan S; Evans, Charlotte El; Nykjaer, Camilla; Hancock, Neil; Cade, Janet E
2014-08-16
Current academic literature suggests that school gardening programmes can provide an interactive environment with the potential to change children's fruit and vegetable intake. This is the first cluster randomised controlled trial (RCT) designed to evaluate whether a school gardening programme can have an effect on children's fruit and vegetable intake. The trial included children from 23 schools; these schools were randomised into two groups, one to receive the Royal Horticultural Society (RHS)-led intervention and the other to receive the less involved Teacher-led intervention. A 24-hour food diary (CADET) was used to collect baseline and follow-up dietary intake 18 months apart. Questionnaires were also administered to evaluate the intervention implementation. A total of 641 children completed the trial with a mean age of 8.1 years (95% CI: 8.0, 8.4). The unadjusted results from multilevel regression analysis revealed that for combined daily fruit and vegetable intake the Teacher-led group had a higher daily mean change of 8 g (95% CI: -19, 36) compared to the RHS-led group -32 g (95% CI: -60, -3). However, after adjusting for possible confounders this difference was not significant (intervention effect: -40 g, 95% CI: -88, 1; p = 0.06). The adjusted analysis of process measures identified that if schools improved their gardening score by 3 levels (a measure of school gardening involvement - the scale has 6 levels from 0 'no garden' to 5 'community involvement'), irrespective of group allocation, children had, on average, a daily increase of 81 g of fruit and vegetable intake (95% CI: 0, 163; p = 0.05) compared to schools that had no change in gardening score. This study is the first cluster randomised controlled trial designed to evaluate a school gardening intervention. The results have found very little evidence to support the claims that school gardening alone can improve children's daily fruit and vegetable intake. However, when a gardening
Edição e tradução, entre a cultura e a política: Argentina e Brasil na Feira do Livro de Frankfurt
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José de Souza Muniz Jr.
Full Text Available Resumo Este artigo analisa a participação da Argentina e do Brasil como países convidados de honra (em 2010 e 2013, respectivamente na Feira do Livro de Frankfurt. Remetemos tais presenças à história recente da feira e ao seu papel na estrutura dos fluxos e circuitos de edição e tradução em nível mundial, estrutura esta regulada pelas relações desiguais entre distintos países e mercados linguísticos. Analisamos as negociações entre entidades do poder público e da política setorial que deram origem a tais participações; as ênfases temáticas escolhidas para compor os estandes; e as características socioprofissionais dos autores de cada delegação. A conclusão é que tais casos permitem observar relações específicas entre intelectuais e Estado em cada contexto, na medida em que fazem emergir não apenas as tensões entre cultura e economia, mas também os modos específicos como cada país “traduz” questões locais para um âmbito de trocas simbólicas transnacionais.
Ethical Considerations in Conducting Pragmatic Trials in Oncology.
Hammer, Marilyn J
2017-09-01
Pragmatic trials evaluate interventions in real-life scenarios, which differ from explanatory trials that control for numerous factors and variables to best determine causal associations. Each approach has advantages and disadvantages. Conducting pragmatic research trials while maintaining the tenets of the ethical conduct of research can sometimes be challenging, particularly regarding informed consent. In this column, distinctions between pragmatic and explanatory trials are discussed from an ethical view.
Clinical trials transparency and the Trial and Experimental Studies Transparency (TEST) act.
Logvinov, Ilana
2014-03-01
Clinical trial research is the cornerstone for successful advancement of medicine that provides hope for millions of people in the future. Full transparency in clinical trials may allow independent investigators to evaluate study designs, perform additional analysis of data, and potentially eliminate duplicate studies. Current regulatory system and publishers rely on investigators and pharmaceutical industries for complete and accurate reporting of results from completed clinical trials. Legislation seems to be the only way to enforce mandatory disclosure of results. The Trial and Experimental Studies Transparency (TEST) Act of 2012 was introduced to the legislators in the United States to promote greater transparency in research industry. Public safety and advancement of science are the driving forces for the proposed policy change. The TEST Act may benefit the society and researchers; however, there are major concerns with participants' privacy and intellectual property protection. Copyright © 2014 Elsevier Inc. All rights reserved.
Jensen, Cathrine Elgaard; Riis, Allan; Pedersen, Kjeld Møller; Jensen, Martin Bach; Petersen, Karin Dam
2014-10-08
In Denmark, guidelines on low back pain management are currently being implemented; in association with this, a clinical trial is conducted. A health economic evaluation is carried out alongside the clinical trial to assess the cost-effectiveness of an extended implementation strategy to increase the general practitioners' adherence to the guidelines. In addition to usual dissemination, the extended implementation strategy is composed of visits from a guideline facilitator, stratification tools, and feedback on guideline adherence. The aim of this paper is to provide the considerations on the design of the health economic evaluation. The economic evaluation is carried out alongside a cluster randomised controlled trial consisting of 60 general practices in the North Denmark Region. An expected 1,200 patients between the age of 18 and 65 years with a low back pain diagnosis will be enrolled. The economic evaluation comprises both a cost-effectiveness analyses and a cost-utility analysis. Effectiveness measures include referral to secondary care, health-related quality of life measured by EQ-5D-5L, and disability measured by the Roland Morris disability questionnaire. Cost measures include all relevant additional costs of the extended implementation strategy compared to usual implementation. The economic evaluation will be performed from both a societal perspective and a health sector perspective with a 12-month time horizon. It is expected that the extended implementation strategy will reduce the number of patients referred to secondary care. It is hypothesised that the additional upfront cost of extended implementation will be counterbalanced by improvements in clinical practice and patient-related outcomes, thereby rendering the extended implementation strategy cost-effective. ClinicalTrials.gov: NCT01699256.
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Mark Boaz
2014-01-01
Full Text Available The CYD tetravalent dengue vaccine candidate is being evaluated for protective efficacy against symptomatic dengue in Phase 3 efficacy trials. The laboratory test algorithm to confirm dengue cases was evaluated prior to Phase 3 trials. During a Phase 2 trial in Latin America a dengue epidemic occurred in the study countries. A total of 72 suspected dengue cases were reported and assessed: virological confirmation comprised qRT-PCR methods and a commercial ELISA kit for NS1 protein (Bio-Rad. The qRT-PCR included a screening assay targeting a conserved dengue region of the 3′-UTR (dengue screen assay followed by 4 individual serotype assays targeting the conserved dengue NS5 genomic region (WT dengue qRT-PCR assays. The NS1 and WT dengue qRT-PCR were endpoint assays for protocol virological confirmation (PVC. Of the 72 suspected cases, 14 were PVC. However, a unique pattern of dengue qRT-PCR results were observed in 5 suspected cases from Honduras: the dengue screen qRT-PCR assay was positive but WT dengue qRT-PCR and NS1 Ag ELISA were negative. To investigate these observations, additional molecular methods were applied: a SYBR® Green-based RT-PCR assay, sequencing assays directed at the genome regions covered by the WT dengue qRT-PCR, and a modified commercial dengue RT-PCR test (Simplexa™ Dengue, Focus Diagnostics. The exploratory data confirmed these additional cases as dengue and indicated the serotype 2 WT dengue qRT-PCR assay was unable to detect a circulating Latin American strain (DENV-2/NI/BID-V608/2006 due to a sequence variation in the isolate. The Simplexa Dengue RT-PCR test was able to detect and serotype dengue. Based on these findings an updated molecular test algorithm for the virological confirmation of dengue cases was developed and implemented in the Phase 3 efficacy trials.
Nutritional management of anorexic patients with and without fluoxetine: 1-year follow-up.
Ruggiero, Giovanni M; Mauri, Massimo C; Omboni, Anna C; Volonteri, Lucia S; Dipasquale, Savina; Malvini, Lara; Redaelli, Gabriella; Pasqualinotto, Lucia; Cavagnini, Francesco
2003-05-01
This study evaluated the efficacy of nutritional management with and without fluoxetine (FLX) in anorexia nervosa diagnosed according to Diagnostic and Statistical Manual of Mental Disorders (DSM-IV) criteria. Twenty-one patients, with a mean body mass index (BMI) of 15.21+/-2.33 kg/m(2), were treated with nutritional management and FLX at a mean dosage of 30.00+/-9.35 mg (pharmacological group); seventy-four patients, with a mean BMI of 14.24+/-2.16 kg/m(2), were treated only with nutritional management (nutritional group). Clinical evaluation was carried out under single-blind conditions at basal time and after 3, 6, and 12 months by a structured clinical interview, the Eating Disorder Interview based on Longitudinal Interval Follow-Up Evaluation (EDI-LIFE) and using a self-reported questionnaire, the Eating Disorder Inventory (EDI). BMI significantly increased in both the two treatment groups. In addition, the increase shown by the pharmacological group appeared near the beginning of treatment (i.e., at T1) and it was significantly higher than the increase shown by the nutritional group. Physical exercise showed a significant decrease in the pharmacological treatment group. On the other hand, fear of fatness and the scores of the subscales of the EDI significantly decreased in the nutritional treatment group. In terms of weight, the pharmacological group presented the higher amount of therapeutic success.
Aulicino, Paula C; Rocco, Carlos A; Mecikovsky, Debora; Bologna, Rosa; Mangano, Andrea; Sen, Luisa
2010-01-01
Patterns and pathways of HIV type-1 (HIV-1) antiretroviral (ARV) drug resistance-associated mutations in clinical isolates are conditioned by ARV history and factors such as viral subtype and fitness. Our aim was to analyse the frequency and association of ARV drug resistance mutations in a group of long-term vertically infected patients from Argentina. Plasma samples from 71 patients (38 children and 33 adolescents) were collected for genotypic HIV-1 ARV resistance testing during the period between February 2006 and October 2008. Statistically significant pairwise associations between ARV resistance mutations in pol, as well as associations between mutations and drug exposure, were identified using Fisher's exact tests with Bonferroni and false discovery rate corrections. Phylogenetic analyses were performed for subtype assignment. In protease (PR), resistance-associated mutations M46I/L, I54M/L/V/A/S and V82A/F/T/S/M/I were associated with each other and with minor mutations at codons 10, 24 and 71. Mutations V82A/F/T/S/M/I were primarily selected by the administration of ritonavir (RTV) in an historical ARV regimen. In reverse transcriptase, thymidine analogue mutation (TAM)1 profile was more common than TAM2. The non-nucleoside K103N+L100I mutations were observed at high frequency (15.5%) and were significantly associated with the nucleoside mutation L74V in BF recombinants. Associations of mutations at PR sites reflect the frequent use of RTV at an early time in this group of patients and convergent resistance mechanisms driven by the high exposure to protease inhibitors, as well as local HIV-1 diversity. The results provide clinical evidence of a molecular interaction between K103N+L100I and L74V mutations at the reverse transcriptase gene in vivo, limiting the future use of second-generation non-nucleoside reverse transcriptase inhibitors such as etravirine.
Lino, A S; Kasper, D; Guida, Y S; Thomaz, J R; Malm, O
2018-07-01
This work aimed to evaluate associated risks of fish consumption to human health, concerning mercury (Hg) and selenium (Se) concentrations in fish species largely consumed in the Tapajós River basin in the Brazilian Amazon. Total mercury (THg), methylmercury (MeHg) and Se concentrations were measured in 129 fish specimens from four sites of the Tapajós River basin. Estimated daily intake (EDI) of Hg and Se were reported regarding fish consumption. EDI were compared with the reference value of provisional tolerable daily intake proposed by the World Health Organization (WHO). Se:Hg ratios and selenium health benefit values (Se HBVs) seem to offer a more comprehensive fish safety model. THg concentrations in fishes ranged from 0.03 to 1.51 μg g -1 of wet weight (w.w.) and MeHg concentrations ranged from 0.02 to 1.44 μg g -1 (w.w.). 80% of the samples were below the value of Hg recommended by the WHO for human consumption (0.5 μg g -1 w.w.). However, Hg EDI exceeded the dose suggested by the United States Environmental Protection Agency (0.1 μg kg -1 day -1 ), due to the large level of fish consumption in that area. Se concentrations in fishes ranged from 0.02 to 0.44 μg g -1 w.w. An inverse pattern was observed between Hg and Se concentrations in the trophic chain (highest levels of Se in the lowest trophic levels). The molar ratio Se:Hg and Se HBVs were higher in iliophagous and herbivorous fishes, which is noteworthy to reduce toxic effects of Hg contamination. For planktivores, the content of Se and Hg was almost equimolar. Carnivorous fishes - with the exception of Hemisorubim platyrhynchos and Pseudoplatystoma fasciatum -, showed Se:Hg ratios <1. Thus, they do not act as a favorable source of Se in the diet. Therefore, reduced intake of carnivorous fishes with preferential consumption of iliophages, herbivores and, to some extent, even planktivores should be promoted as part of a healthier diet. Copyright © 2018 Elsevier GmbH. All
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Inma Aznar
Full Text Available A long-term research programme has been underway in Ireland to evaluate the usefulness of badger vaccination as part of the national bTB (bovine tuberculosis control strategy. This culminated in a field trial which commenced in county Kilkenny in 2009 to determine the effects of badger vaccination on Mycobacterium bovis transmission in badgers under field conditions. In the present study, we sought to optimise the characteristics of a multiplex chemiluminescent assay for detection of M. bovis infection in live badgers. Our goal was to maximise specificity, and therefore statistical power, during evaluation of the badger vaccine trial data. In addition, we also aimed to explore the effects of vaccination on test characteristics. For the test optimisation, we ran a stepwise logistic regression with analytical weights on the converted Relative Light Units (RLU obtained from testing blood samples from 215 badgers captured as part of culling operations by the national Department of Agriculture, Food and the Marine (DAFM. The optimised test was applied to two other datasets obtained from two captive badger studies (Study 1 and Study 2, and the sensitivity and specificity of the test was attained separately for vaccinated and non-vaccinated badgers. During optimisation, test sensitivity was maximised (30.77%, while retaining specificity at 99.99%. When the optimised test was then applied to the captive badger studies data, we observed that test characteristics did not vary greatly between vaccinated and non-vaccinated badgers. However, a different time lag between infection and a positive test result was observed in vaccinated and non-vaccinated badgers. We propose that the optimized multiplex immunoassay be used to analyse the vaccine trial data. In relation to the difference in the time lag observed for vaccinated and non-vaccinated badgers, we also present a strategy to enable the test to be used during trial evaluation.
Evaluation of a workplace treadmill desk intervention: a randomized controlled trial.
Schuna, John M; Swift, Damon L; Hendrick, Chelsea A; Duet, Megan T; Johnson, William D; Martin, Corby K; Church, Timothy S; Tudor-Locke, Catrine
2014-12-01
To evaluate the effectiveness of a 3-month treadmill desk intervention in eliciting changes in physical activity and sedentary behavior among overweight/obese office workers. A randomized controlled trial was conducted among overweight/obese office workers (n = 41; mean age = 40.1 ± 10.1 years) at a private workplace. Participants were randomly assigned to a shared-treadmill desk intervention (n = 21) or a usual working condition control group (n = 20). Accelerometer-determined physical activity and sedentary behavior were measured before and after the intervention. Compared with the control group, the intervention group increased daily steps (1622 steps/day; P = 0.013) and light physical activity (1.6 minutes/hour; P = 0.008), and decreased sedentary time (-3.6 minutes/hour; P = 0.047) during working hours. Shared-treadmill desks in the workplace can be effective at promoting favorable changes in light physical activity (specifically 40 to 99 steps/minute) and sedentary behavior among overweight/obese office workers.
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Vester-Andersen Morten
2013-02-01
Full Text Available Abstract Background Emergency abdominal surgery carries a 15% to 20% short-term mortality rate. Postoperative medical complications are strongly associated with increased mortality. Recent research suggests that timely recognition and effective management of complications may reduce mortality. The aim of the present trial is to evaluate the effect of postoperative intermediate care following emergency major abdominal surgery in high-risk patients. Methods and design The InCare trial is a randomised, parallel-group, non-blinded clinical trial with 1:1 allocation. Patients undergoing emergency laparotomy or laparoscopic surgery with a perioperative Acute Physiology and Chronic Health Evaluation II score of 10 or above, who are ready to be transferred to the surgical ward within 24 h of surgery are allocated to either intermediate care for 48 h, or surgical ward care. The primary outcome measure is all-cause 30-day mortality. We aim to enrol 400 patients in seven Danish hospitals. The sample size allows us to detect or refute a 34% relative risk reduction of mortality with 80% power. Discussion This trial evaluates the benefits and possible harm of intermediate care. The results may potentially influence the survival of many high-risk surgical patients. As a pioneer trial in the area, it will provide important data on the feasibility of future large-scale randomised clinical trials evaluating different levels of postoperative care. Trial registration Clinicaltrials.gov identifier: NCT01209663
Standards for reporting randomized controlled trials in neurosurgery.
Kiehna, Erin N; Starke, Robert M; Pouratian, Nader; Dumont, Aaron S
2011-02-01
The Consolidated Standards for Reporting of Trials (CONSORT) criteria were published in 1996 to standardize the reporting and improve the quality of clinical trials. Despite having been endorsed by major medical journals and shown to improve the quality of reported trials, neurosurgical journals have yet to formally adopt these reporting criteria. The purpose of this study is to evaluate the quality and reporting of randomized controlled trials (RCTs) in neurosurgery and the factors that may affect the quality of reported trials. The authors evaluated all neurosurgical RCTs published in 2006 and 2007 in the principal neurosurgical journals (Journal of Neurosurgery; Neurosurgery; Surgical Neurology; Journal of Neurology, Neurosurgery, and Psychiatry; and Acta Neurochirurgica) and in 3 leading general medical journals (Journal of the American Medical Association, Lancet, and the New England Journal of Medicine). Randomized controlled trials that addressed operative decision making or the treatment of neurosurgical patients were included in this analysis. The RCT quality was evaluated using the Jadad score and the CONSORT checklist. In 2006 and 2007, 27 RCTs relevant to intracranial neurosurgery were reported. Of these trials, only 59% had a Jadad score ≥ 3. The 3 major medical journals all endorsed the CONSORT guidelines, while none of the neurosurgical journals have adopted these guidelines. Randomized controlled trials published in the 3 major medical journals had a significantly higher mean CONSORT score (mean 41, range 39-44) compared with those published in neurosurgical journals (mean 26.4, range 17-38; p journals (mean 3.42, range 2-5) than neurosurgical journals (mean 2.45, range 1-5; p = 0.05). Despite the growing volume of RCTs in neurosurgery, the quality of reporting of these trials remains suboptimal, especially in the neurosurgical journals. Improved awareness of the CONSORT guidelines by journal editors, reviewers, and authors of these papers could
[Lower Uterine Segment Trial: A pragmatic open multicenter randomized trial].
Rozenberg, P; Deruelle, P; Sénat, M-V; Desbrière, R; Winer, N; Simon, E; Ville, Y; Kayem, G; Boutron, I
2018-04-01
The data from literature show that trial of labor and elective repeat cesarean delivery after a prior cesarean delivery both present significant risks and benefits, and these risks and benefits differ for the woman and her fetus. The benefits to the woman can be at the expense of her fetus and vice-versa. This uncertainty is compounded by the scarcity of high-level evidence that preclude accurate quantification of the risks and benefits that could help provide a fair counseling about a trial of labor and elective repeat cesarean delivery. An interesting way of research is to evaluate the potential benefits of a decision rule associated to the ultrasound measurement of the lower uterine segment (LUS). Indeed, ultrasonography may be helpful in determining a specific risk for a given patient by measuring the thickness of the LUS, i,e, the thickness of the cesarean delivery scar area. Although only small and often methodologically biased data have been published, they look promising as their results are concordant: ultrasonographic measurements of the LUS thickness is highly correlated with the intraoperative findings at cesarean delivery. Furthermore, the thinner the LUS becomes on ultrasound, the higher the likelihood of a defect in the LUS. Finally, ultrasound assessment of LUS has an excellent negative predictive value for the risk of uterine defect. Therefore, this exam associated with a rule of decision could help to reduce the rate of elective repeat cesarean delivery and especially to reduce the fetal and maternal mortality and morbidity related to trial of labor after a prior cesarean delivery. This is a pragmatic open multicenter randomized trial with two parallel arms. Randomization will be centralized and computerized. Since blindness is impossible, an adjudication committee will evaluate the components of the primary composite outcome in order to avoid evaluation bias. An interim analysis will be planned mid-strength of the trial. Ultrasound will be
Electronic Data Interchange: from its Birth to its New Role in Logistics Information Systems
Janssens, Gerrit K.
2011-01-01
The introduction of internet applications in e-commerce made many adopters think that EDI would soon disappear. But the trend in logistics towards closer collaboration in supply chains made on the other hand the impact of EDI larger. A resultant of those forces will probably lead to a new type of EDI, which integrates with other technologies. Early studies on EDI were promoting its use because of savings in administrative work. But due to intra-corporation management model...
Identification of User Needs. EDIS Task I Report.
Howard Research Co., Arlington, VA.
This report presents the identification of user needs in the Army research, development, test and evaluation (RDT&E) community. Two types of information are provided in this report. The first type includes discussions of the RDT&E cycle, the level of informational need, time response, item categories and other factors as they relate to the…
Can we identify non-stationary dynamics of trial-to-trial variability?
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Emili Balaguer-Ballester
Full Text Available Identifying sources of the apparent variability in non-stationary scenarios is a fundamental problem in many biological data analysis settings. For instance, neurophysiological responses to the same task often vary from each repetition of the same experiment (trial to the next. The origin and functional role of this observed variability is one of the fundamental questions in neuroscience. The nature of such trial-to-trial dynamics however remains largely elusive to current data analysis approaches. A range of strategies have been proposed in modalities such as electro-encephalography but gaining a fundamental insight into latent sources of trial-to-trial variability in neural recordings is still a major challenge. In this paper, we present a proof-of-concept study to the analysis of trial-to-trial variability dynamics founded on non-autonomous dynamical systems. At this initial stage, we evaluate the capacity of a simple statistic based on the behaviour of trajectories in classification settings, the trajectory coherence, in order to identify trial-to-trial dynamics. First, we derive the conditions leading to observable changes in datasets generated by a compact dynamical system (the Duffing equation. This canonical system plays the role of a ubiquitous model of non-stationary supervised classification problems. Second, we estimate the coherence of class-trajectories in empirically reconstructed space of system states. We show how this analysis can discern variations attributable to non-autonomous deterministic processes from stochastic fluctuations. The analyses are benchmarked using simulated and two different real datasets which have been shown to exhibit attractor dynamics. As an illustrative example, we focused on the analysis of the rat's frontal cortex ensemble dynamics during a decision-making task. Results suggest that, in line with recent hypotheses, rather than internal noise, it is the deterministic trend which most likely underlies
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Görres Stefan
2008-07-01
Full Text Available Abstract Background Cancer-related fatigue (CRF and its impact on patients' quality of life has been an increasing subject of research. However, in Germany there is a lack of evidence-based interventions consistent with the multidimensional character of fatigue. The objective of this study is to develop and evaluate a self-management program for disease-free cancer patients to cope with CRF. Methods Based on evidence extracted from a literature review, a curriculum for the self-management program was elaborated. The curriculum was reviewed and validated by an interdisciplinary expert group and the training-modules will be pretested with a small number of participants and discussed in terms of feasibility and acceptance. To determine the efficacy of the program a randomised controlled trial will be carried out: 300 patients will be recruited from oncological practices in Bremen, Germany, and will be allocated to intervention or control group. The intervention group participates in the program, whereas the control group receives standard care and the opportunity to take part in the program after the end of the follow-up (waiting control group. Primary outcome measure is the level of fatigue, secondary outcome measures are quality of life, depression, anxiety, self-efficacy and physical activity. Data will be collected before randomisation, after intervention, and after a follow-up of 6 months. Discussion Because there are no comparable self-management programs for cancer survivors with fatigue, the development of the curriculum has been complex; therefore, the critical appraisal by the experts was an important step to validate the program and their contributions have been integrated into the curriculum. The experts appreciated the program as filling a gap in outpatient cancer care. If the results of the evaluation prove to be satisfactory, the outpatient care of cancer patients can be broadened and supplemented. Trial Registration ClinicalTrials
Palladino, Benedetta E; Nocentini, Annalaura; Menesini, Ersilia
2016-01-01
The NoTrap! (Noncadiamointrappola!) program is a school-based intervention, which utilizes a peer-led approach to prevent and combat both traditional bullying and cyberbullying. The aim of the present study was to evaluate the efficacy of the third Edition of the program in accordance with the recent criteria for evidence-based interventions. Towards this aim, two quasi-experimental trials involving adolescents (age M = 14.91, SD = .98) attending their first year at different high schools were conducted. In Trial 1 (control group, n = 171; experimental group, n = 451), latent growth curve models for data from pre-, middle- and post-tests showed that intervention significantly predicted change over time in all the target variables (victimization, bullying, cybervictimization, and cyberbullying). Specifically, target variables were stable for the control group but decreased significantly over time for the experimental group. Long-term effects at the follow up 6 months later were also found. In Trial 2 (control group, n = 227; experimental group, n = 234), the moderating effect of gender was examined and there was a reported decrease in bullying and cyberbullying over time (pre- and post-test) in the experimental group but not the control group, and this decrease was similar for boys and girls. © 2016 Wiley Periodicals, Inc.
Fitzgerald, Sarah; Geaney, Fiona; Kelly, Clare; McHugh, Sheena; Perry, Ivan J.
2016-01-01
Background Ambiguity exists regarding the effectiveness of workplace dietary interventions. Rigorous process evaluation is vital to understand this uncertainty. This study was conducted as part of the Food Choice at Work trial which assessed the comparative effectiveness of a workplace environmental dietary modification intervention and an educational intervention both alone and in combination versus a control workplace. Effectiveness was assessed in terms of employees? dietary intakes, nutri...
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Nouwens Femke
2013-01-01
Full Text Available Abstract Background Aphasia is a severely disabling condition occurring in 20 to 25% of stroke patients. Most patients with aphasia due to stroke receive speech and language therapy. Methodologically sound randomised controlled trials investigating the effect of specific interventions for patients with aphasia following stroke are scarce. The currently available evidence suggests that intensive speech and language therapy is beneficial for restoration of communication, but the optimal timing of treatment is as yet unclear. In the Rotterdam Aphasia Therapy Study-3 we aim to test the hypothesis that patients with aphasia due to stroke benefit more from early intensive cognitive-linguistic therapy than from deferred regular language therapy. Methods/design In a single blinded, multicentre, randomised controlled trial, 150 patients with first ever aphasia due to stroke will be randomised within two weeks after stroke to either early intensive cognitive-linguistic therapy (Group A or deferred regular therapy (Group B. Group A will start as soon as possible, at the latest two weeks after stroke, with a four week period of one hour a day treatment with cognitive-linguistic therapy. In Group B professional speech and language therapy is deferred for four weeks. After this period, patients will follow the conventional procedure of speech and language therapy. Participants will be tested with an extensive linguistic test battery at four weeks, three months and six months after inclusion. Primary outcome measure is the difference in score between the two treatment groups on the Amsterdam-Nijmegen Everyday Language Test, a measure of everyday verbal communication, four weeks after randomisation. Trial registration This trial is registered in the Dutch Trial Register (http://www.trialregister.nl, NTR3271.
Hooker, Leesa; Small, Rhonda; Taft, Angela
2016-03-01
To investigate factors contributing to the sustained domestic violence screening and support practices of Maternal and Child Health nurses 2 years after a randomized controlled trial. Domestic violence screening by healthcare professionals has been implemented in many primary care settings. Barriers to screening exist and screening rates remain low. Evidence for longer term integration of nurse screening is minimal. Trial outcomes showed sustained safety planning behaviours by intervention group nurses. Process evaluation in 2-year follow-up of a cluster randomized controlled trial. Evaluation included a repeat online nurse survey and 14 interviews (July-September 2013). Survey analysis included comparison of proportionate group difference between arms and between trial baseline and 2 year follow-up surveys. Framework analysis was used to assess qualitative data. Normalization Process Theory informed evaluation design and interpretation of results. Survey response was 77% (n = 123/160). Sustainability of nurse identification of domestic violence appeared to be due to greater nurse discussion and domestic violence disclosure by women, facilitated by use of a maternal health and well-being checklist. Over time, intervention group nurses used the maternal checklist more at specific maternal health visits and found the checklist the most helpful resource assisting their domestic violence work. Nurses' spoke of a degree of 'normalization' to domestic violence screening that will need constant investment to maintain. Sustainable domestic violence screening and support outcomes can be achieved in an environment of comprehensive, nurse designed and theory driven implementation. Continuing training, discussion and monitoring of domestic violence work is needed to retain sustainable practices. © 2015 John Wiley & Sons Ltd.
Directory of Open Access Journals (Sweden)
Victoria Jane Palmer
2016-10-01
Full Text Available Background: Process evaluations are essential to understand the contextual, relational, and organizational and system factors of complex interventions. The guidance for developing process evaluations for randomized controlled trials (RCTs has until recently however, been fairly limited. Method/Design: A nested process evaluation (NPE was designed and embedded across all stages of a stepped wedge cluster RCT called the CORE study. The aim of the CORE study is to test the effectiveness of an experience-based codesign methodology for improving psychosocial recovery outcomes for people living with severe mental illness (service users. Process evaluation data collection combines qualitative and quantitative methods with four aims: (1 to describe organizational characteristics, service models, policy contexts, and government reforms and examine the interaction of these with the intervention; (2 to understand how the codesign intervention works, the cluster variability in implementation, and if the intervention is or is not sustained in different settings; (3 to assist in the interpretation of the primary and secondary outcomes and determine if the causal assumptions underpinning the codesign interventions are accurate; and (4 to determine the impact of a purposefully designed engagement model on the broader study retention and knowledge transfer in the trial. Discussion: Process evaluations require prespecified study protocols but finding a balance between their iterative nature and the structure offered by protocol development is an important step forward. Taking this step will advance the role of qualitative research within trials research and enable more focused data collection to occur at strategic points within studies.
Directory of Open Access Journals (Sweden)
Fernanda Jansen Mira Catanho
2007-01-01
Full Text Available This article, based on the concept of intellectual montage, developed by russian movie director Sergei Eisenstein, works in the premises that the photographic edition may be responsible for the construction of a visual narrative. Thus, it adopts a photographic essay composed of 26 pictures and sends it to three specialists for edition. The results are three different narratives. With this, it becomes evident that the photographic message may undergo a creative rearrange and compose distinctive enunciation discourses. At the end, the work shows that the differences between the discourses elaborated by the editors are captured by the receiver of the photographic message. Este artigo, baseado no conceito de montagem intelectual, desenvolvido pelo cineasta russo Sergei Eisenstein, trabalha com a premissa de que a edição fotográfica pode ser responsável pela construção de uma narrativa visual. Para tanto, adota um ensaio fotográfico composto por 26 fotografias e o passa para três especialistas editá-lo. O resultado são três narrativas diferentes. Com isso, torna-se evidente que a mensagem fotográfica pode passar por uma re-elaboração criativa e formar discursos enunciativos distintos. Ao final, o trabalho mostra que as diferenças entre os discursos elaborados pelos editores são apreendidos pelo receptor da mensagem fotográfica.
48 CFR 552.232-25 - Prompt Payment.
2010-10-01
... electronic data interchange (EDI) purchase orders (transaction set 850). (ii) The Contractor must generate and submit to the Government valid EDI invoices (transaction set 810) or submit invoices through the... of the Contractor, EFT payments through the Automated Clearing House (ACH) system. (iv) The EDI...
2012-04-06
... Interchange (EDI). This notice also describes test particulars including commencement date, eligibility... Electronic Data Interchange (EDI) as part of the Document Image System (DIS) test. DIS is currently a stand... with supporting information via EDI in an Extensible Markup Language (XML) format, in lieu of...
2012-06-12
... report EDI Electronic data interchange FHWA Federal Highway Administration FMCSRs Federal Motor Carrier...-copy paperwork to unassisted electronic data interchange (EDI) transmissions. IANA added that the... system, or EDI and transmittals of files in various formats. IANA noted that its program offers IEPs and...
Sanchez, Victoria A; Hall, Deborah A; Millar, Bonnie; Escabi, Celia D; Sharman, Alice; Watson, Jeannette; Thasma, Sornaraja; Harris, Peter
2018-01-21
Recruiting into clinical trials on time and on target is a major challenge and yet often goes unreported. This study evaluated the adjustment to procedures, recruitment and screening methods in two multi-centre pharmaceutical randomised controlled trials (RCTs) for hearing-related problems in adults. Recruitment monitoring and subsequent adjustment of various study procedures (e.g. eligibility criteria, increasing recruiting sites and recruitment methods) are reported. Participants were recruited through eight overarching methods: trial registration, posters/flyers, print publications, Internet, social media, radio, databases and referrals. The efficiency of the recruitment was measured by determining the number of people: (1) eligible for screening as a percentage of those who underwent telephone pre-screening and (2) randomised as a percentage of those screened. A total of 584 participants completed the pre-screening steps, 491 screened and 169 participants were randomised. Both RCTs completed adjustments to the participant eligibility, added new study sites and additional recruitment methods. No single recruitment method was efficient enough to serve as the only route to enrolment. A diverse portfolio of methods, continuous monitoring, mitigation strategy and adequate resourcing were essential for achieving our recruitment goals.
Severi, Ettore; Free, Caroline; Knight, Rosemary; Robertson, Steven; Edwards, Philip; Hoile, Elizabeth
2011-10-01
Loss to follow-up of trial participants represents a threat to research validity. To date, interventions designed to increase participants' awareness of benefits to society of completing follow-up, and the impact of a telephone call from a senior female clinician and researcher requesting follow-up have not been evaluated robustly. Trial 1 aimed to evaluate the effect on trial follow-up of written information regarding the benefits of participation to society. Trial 2 aimed to evaluate the effect on trial follow-up of a telephone call from a senior female clinician and researcher. Two single-blind randomized controlled trials were nested within a larger trial, Txt2stop. In Trial 1, participants were allocated using minimization to receive a refrigerator magnet and a text message emphasizing the benefits to society of completing follow-up, or to a control group receiving a simple reminder regarding follow-up. In Trial 2, participants were randomly allocated to receive a telephone call from a senior female clinician and researcher, or to a control group receiving standard Txt2stop follow-up procedures. Trial 1: 33.5% (327 of 976) of the intervention group and 33.8% (329 of 974) of the control group returned the questionnaire within 26 weeks of randomization, risk ratio (RR) 0.99; 95% confidence interval (CI) 0.88-1.12. In all, 83.3% (813 of 976) of the intervention group and 82.2% (801 of/974) of the control group sent back the questionnaire within 30 weeks of randomization, RR 1.01; 95% CI 0.97, 1.05. Trial 2: 31% (20 of 65) of the intervention group and 32% (20 of 62) of the control group completed trial follow-up, RR 0.93; 95%CI 0.44, 1.98. In presence of other methods to increase follow-up neither experimental method (refrigerator magnet and text message emphasizing participation's benefits to society nor a telephone call from study's principal investigator) increased participant follow-up in the Txt2stop trial.
ter Huurne, Elke D; de Haan, Hein A; Postel, Marloes G; van der Palen, Job; VanDerNagel, Joanne E L; DeJong, Cornelis A J
2015-06-18
Many patients with eating disorders do not receive help for their symptoms, even though these disorders have severe morbidity. The Internet may offer alternative low-threshold treatment interventions. This study evaluated the effects of a Web-based cognitive behavioral therapy (CBT) intervention using intensive asynchronous therapeutic support to improve eating disorder psychopathology, and to reduce body dissatisfaction and related health problems among patients with eating disorders. A two-arm open randomized controlled trial comparing a Web-based CBT intervention to a waiting list control condition (WL) was carried out among female patients with bulimia nervosa (BN), binge eating disorder (BED), and eating disorders not otherwise specified (EDNOS). The eating disorder diagnosis was in accordance with the Diagnostic and Statistical Manual of Mental Disorders, 4th edition, and was established based on participants' self-report. Participants were recruited from an open-access website, and the intervention consisted of a structured two-part program within a secure Web-based application. The aim of the first part was to analyze participant's eating attitudes and behaviors, while the second part focused on behavioral change. Participants had asynchronous contact with a personal therapist twice a week, solely via the Internet. Self-report measures of eating disorder psychopathology (primary outcome), body dissatisfaction, physical health, mental health, self-esteem, quality of life, and social functioning were completed at baseline and posttest. A total of 214 participants were randomized to either the Web-based CBT group (n=108) or to the WL group (n=106) stratified by type of eating disorder (BN: n=44; BED: n=85; EDNOS: n=85). Study attrition was low with 94% of the participants completing the posttest assignment. Overall, Web-based CBT showed a significant improvement over time for eating disorder psychopathology (F97=63.07, PWeb-based CBT participants in all three
Sung, Cynthia; Wei, Yuan; Watanabe, Satoru; Lee, How Sung; Khoo, Yok Moi; Fan, Lu; Rathore, Abhay P S; Chan, Kitti Wing-Ki; Choy, Milly M; Kamaraj, Uma S; Sessions, October M; Aw, Pauline; de Sessions, Paola F; Lee, Bernett; Connolly, John E; Hibberd, Martin L; Vijaykrishna, Dhanasekaran; Wijaya, Limin; Ooi, Eng Eong; Low, Jenny Guek-Hong; Vasudevan, Subhash G
2016-08-01
CELADEN was a randomized placebo-controlled trial of 50 patients with confirmed dengue fever to evaluate the efficacy and safety of celgosivir (A study registered at ClinicalTrials.gov, number NCT01619969). Celgosivir was given as a 400 mg loading dose and 200 mg bid (twice a day) over 5 days. Replication competent virus was measured by plaque assay and compared to reverse transcription quantitative PCR (qPCR) of viral RNA. Pharmacokinetics (PK) correlations with viremia, immunological profiling, next generation sequence (NGS) analysis and hematological data were evaluated as exploratory endpoints here to identify possible signals of pharmacological activity. Viremia by plaque assay strongly correlated with qPCR during the first four days. Immunological profiling demonstrated a qualitative shift in T helper cell profile during the course of infection. NGS analysis did not reveal any prominent signature that could be associated with drug treatment; however the phylogenetic spread of patients' isolates underlines the importance of strain variability that may potentially confound interpretation of dengue drug trials conducted during different outbreaks and in different countries. Celgosivir rapidly converted to castanospermine (Cast) with mean peak and trough concentrations of 5727 ng/mL (30.2 μM) and 430 ng/mL (2.3 μM), respectively and cleared with a half-life of 2.5 (± 0.6) hr. Mean viral log reduction between day 2 and 4 (VLR2-4) was significantly greater in secondary dengue than primary dengue (p = 0.002). VLR2-4 did not correlate with drug AUC but showed a trend of greater response with increasing Cmin. PK modeling identified dosing regimens predicted to achieve 2.4 to 4.5 times higher Cmin. than in the CELADEN trial for only 13% to 33% increase in overall dose. A small, non-statistical trend towards better outcome on platelet nadir and difference between maximum and minimum hematocrit was observed in celgosivir-treated patients with secondary dengue
DEFF Research Database (Denmark)
Geisler, Christian H; van T' Veer, Mars B; Jurlander, Jesper
2014-01-01
.3%). FCA improves progression-free survival in high-risk chronic lymphocytic leukemia. As anticipated, FCA is more immunosuppressive than FC, but with due vigilance, does not lead to a higher treatment-related mortality. This study was registered at www.trialregister.nl as trial no. NTR529....
Krusche, Adele; Rudolf von Rohr, Isabelle; Muse, Kate; Duggan, Danielle; Crane, Catherine; Williams, J Mark G
2014-04-01
Randomized controlled trials (RCTs) are widely accepted as being the most efficient way of investigating the efficacy of psychological therapies. However, researchers conducting RCTs commonly report difficulties in recruiting an adequate sample within planned timescales. In an effort to overcome recruitment difficulties, researchers often are forced to expand their recruitment criteria or extend the recruitment phase, thus increasing costs and delaying publication of results. Research investigating the effectiveness of recruitment strategies is limited, and trials often fail to report sufficient details about the recruitment sources and resources utilized. We examined the efficacy of strategies implemented during the Staying Well after Depression RCT in Oxford to recruit participants with a history of recurrent depression. We describe eight recruitment methods utilized and two further sources not initiated by the research team and examine their efficacy in terms of (1) the return, including the number of potential participants who contacted the trial and the number who were randomized into the trial; (2) cost-effectiveness, comprising direct financial cost and manpower for initial contacts and randomized participants; and (3) comparison of sociodemographic characteristics of individuals recruited from different sources. Poster advertising, web-based advertising, and mental health worker referrals were the cheapest methods per randomized participant; however, the ratio of randomized participants to initial contacts differed markedly per source. Advertising online, via posters, and on a local radio station were the most cost-effective recruitment methods for soliciting participants who subsequently were randomized into the trial. Advertising across many sources (saturation) was found to be important. It may not be feasible to employ all the recruitment methods used in this trial to obtain participation from other populations, such as those currently unwell, or in
Directory of Open Access Journals (Sweden)
Nora Döring
2018-03-01
Full Text Available BackgroundChildhood obesity is a major clinical and economic health concern. Alongside the clinical understanding of obesity, there is a growing interest in designing and implementing interventions that are worth their money given the scarce resources in the health care sector. This study is one of the first efforts to provide evidence by assessing the effects and costs of a population-based primary prevention intervention targeting pre-school children attending child health centers in Sweden.MethodsThe economic evaluation is based on the PRIMROSE cluster-randomized controlled trial aiming to establish healthy eating and physical activity among pre-school children (9–48 months of age through motivational interviewing applied by trained nurses at child health centers. The cost-effectiveness is assessed over the trial period from a societal perspective. The primary outcome was BMI at age 4. Cost data was prospectively collected alongside the trial. Scenario analyses were carried out to identify uncertainty.ResultsThe estimated additional mean total costs of the PRIMROSE intervention were 342 Euro (95% CI: 334; 348 per child. During pre-school years direct costs mainly consist of training costs and costs for the additional time used by nurses to implement the intervention compared to usual care. Early indirect costs mainly consist of parents’ absence from work due to their participation in the intervention. The incremental cost-effectiveness ratio in the base case analysis was 3,109 Euro per 1 BMI unit prevented.ConclusionWe cannot provide evidence that the PRIMROSE intervention is cost-effective, given the uncertainty in the effect measure. Until further evidence is provided, we recommend resources to be spent elsewhere within the field of obesity prevention. Furthermore, to achieve valid and reliable cost-effectiveness results, the economic evaluation of obesity prevention programs in early childhood should incorporate the life time
Electronic data intercharge: from its birth to its new role in logistics information systems
JANSSENS, Gerrit
2011-01-01
The introduction of internet applications in e-commerce made many adopters think that EDI would soon disappear. But the trend in logistics towards closer collaboration in supply chains made on the other hand the impact of EDI larger. A resultant of those forces will probably lead to a new type of EDI, which integrates with other technologies. Early studies on EDI were promoting its use because of savings in administrative work. But due to intra-corporation management model changes, to...
Directory of Open Access Journals (Sweden)
Menz Hylton B
2008-09-01
Full Text Available Abstract Background Cost of illness studies show that Parkinson disease (PD is costly for individuals, the healthcare system and society. The costs of PD include both direct and indirect costs associated with falls and related injuries. Methods This protocol describes a prospective economic analysis conducted alongside a randomised controlled trial (RCT. It evaluates whether physical therapy is more cost effective than usual care from the perspective of the health care system. Cost effectiveness will be evaluated using a three-way comparison of the cost per fall averted and the cost per quality adjusted life year saved across two physical therapy interventions and a control group. Conclusion This study has the potential to determine whether targetted physical therapy as an adjunct to standard care can be cost effective in reducing falls in people with PD. Trial Registration No: ACTRN12606000344594
van den Berg, Sanne W; Peters, Esmee J; Kraaijeveld, J Frank; Gielissen, Marieke F M; Prins, Judith B
2013-08-19
defined. Low and high users differed significantly on frequency (PWeb-based interventions. It is recommended to (1) incorporate usage statistics that reflect the amount of self-tailoring applied by users, (2) combine technical usage statistics with self-reported usefulness, and (3) use qualitative measures. Also, (4) a pilot usage evaluation should be a fixed step in the development process of novel Web-based interventions, and (5) it is essential for researchers to gain insight into the rationale of recorded and nonrecorded usage statistics. Netherlands Trial Register (NTR): 2935; http://www.trialregister.nl/trialreg/admin/rctview.asp?TC=2935 (Archived by WebCite at http://www.webcitation.org/6IkX1ADEV).
How completely are physiotherapy interventions described in reports of randomised trials?
Yamato, Tiê P; Maher, Chris G; Saragiotto, Bruno T; Hoffmann, Tammy C; Moseley, Anne M
2016-06-01
Incomplete descriptions of interventions are a common problem in reports of randomised controlled trials. To date no study has evaluated the completeness of the descriptions of physiotherapy interventions. To evaluate the completeness of the descriptions of physiotherapy interventions in a random sample of reports of randomised controlled trials (RCTs). A random sample of 200 reports of RCTs from the PEDro database. We included full text papers, written in English, and reporting trials with two arms. We included trials evaluating any type of physiotherapy interventions and subdisciplines. The methodological quality was evaluated using the PEDro scale and completeness of intervention description using the Template for Intervention Description and Replication (TIDieR) checklist. The proportion and 95% confidence interval were calculated for intervention and control groups, and used to present the relationship between completeness and methodological quality, and subdisciplines. Completeness of intervention reporting in physiotherapy RCTs was poor. For intervention groups, 46 (23%) trials did not describe at least half of the items. Reporting was worse for control groups, 149 (75%) trials described less than half of the items. There was no clear difference in the completeness across subdisciplines or methodological quality. Our sample were restricted to trials published in English in 2013. Descriptions of interventions in physiotherapy RCTs are typically incomplete. Authors and journals should aim for more complete descriptions of interventions in physiotherapy trials. Copyright © 2016 Chartered Society of Physiotherapy. Published by Elsevier Ltd. All rights reserved.
2011-07-19
... the e-mail any past electronic data interchange (EDI) history with CBP. Written comments concerning... be transmitted in advance of arrival through a CBP-approved electronic data interchange (EDI).The..., 2008).\\1\\ Currently, the Automated Commercial System (ACS) is the CBP-approved EDI through which this...
2011-08-18
... through use of electronic data interchange (EDI). The IVOHMA states ``differences in hazard communication... and on the possible effects EDI may have on distributing hazardous materials shipping paper... consider the use of EDI in other modes of transport in a future rulemaking. Petition No. P-1567 PHMSA...
2012-03-29
... electronic data interchange (EDI) system. CBP recently completed the testing of the Automated Commercial..., after a six month transition period, ACE will be the only CBP-approved EDI for submitting required...-approved EDI for transmitting to CBP required advance information for ocean and rail cargo. FOR FURTHER...
2012-06-25
...'' are added to Sec. 171.8. Requirements for electronic shipping papers, electronic data interchange (EDI... electronic shipping paper information transmitted by EDI for the development of shipping papers used to... shipping papers by carriers. Most of the commenters support amending the HMR to permit EDI transmission of...
Design management of electronic data interchange systems
Heck, van H.W.G.M.
1993-01-01
This study deals with the management of the design process of Electronic Data Interchange (EDI) systems. Its objectives are (1) to investigate the design process of EDI systems from a practical and theoretical perspective; (2) to develop a model to describe factors relevant to EDI
Hartley, Suzanne; Foy, Robbie; Walwyn, Rebecca E A; Cicero, Robert; Farrin, Amanda J; Francis, Jill J; Lorencatto, Fabiana; Gould, Natalie J; Grant-Casey, John; Grimshaw, Jeremy M; Glidewell, Liz; Michie, Susan; Morris, Stephen; Stanworth, Simon J
2017-07-03
Blood for transfusion is a frequently used clinical intervention, and is also a costly and limited resource with risks. Many transfusions are given to stable and non-bleeding patients despite no clear evidence of benefit from clinical studies. Audit and feedback (A&F) is widely used to improve the quality of healthcare, including appropriate use of blood. However, its effects are often inconsistent, indicating the need for coordinated research including more head-to-head trials comparing different ways of delivering feedback. A programmatic series of research projects, termed the 'Audit and Feedback INterventions to Increase evidence-based Transfusion practIcE' (AFFINITIE) programme, aims to test different ways of developing and delivering feedback within an existing national audit structure. The evaluation will comprise two linked 2×2 factorial, cross-sectional cluster-randomised controlled trials. Each trial will estimate the effects of two feedback interventions, 'enhanced content' and 'enhanced follow-on support', designed in earlier stages of the AFFINITIE programme, compared to current practice. The interventions will be embedded within two rounds of the UK National Comparative Audit of Blood Transfusion (NCABT) focusing on patient blood management in surgery and use of blood transfusions in patients with haematological malignancies. The unit of randomisation will be National Health Service (NHS) trust or health board. Clusters providing care relevant to the audit topics will be randomised following each baseline audit (separately for each trial), with stratification for size (volume of blood transfusions) and region (Regional Transfusion Committee). The primary outcome for each topic will be the proportion of patients receiving a transfusion coded as unnecessary. For each audit topic a linked, mixed-method fidelity assessment and cost-effectiveness analysis will be conducted in parallel to the trial. AFFINITIE involves a series of studies to explore how A
McLeod, Sharynne; Baker, Elise; McCormack, Jane; Wren, Yvonne; Roulstone, Sue; Crowe, Kathryn; Masso, Sarah; White, Paul; Howland, Charlotte
2017-01-01
Purpose: The aim was to evaluate the effectiveness of computer-assisted input-based intervention for children with speech sound disorders (SSD). Method: The Sound Start Study was a cluster-randomized controlled trial. Seventy-nine early childhood centers were invited to participate, 45 were recruited, and 1,205 parents and educators of 4- and…
Pagidipati, Neha J; Navar, Ann Marie; Pieper, Karen S; Green, Jennifer B; Bethel, M Angelyn; Armstrong, Paul W; Josse, Robert G; McGuire, Darren K; Lokhnygina, Yuliya; Cornel, Jan H; Halvorsen, Sigrun; Strandberg, Timo E; Delibasi, Tuncay; Holman, Rury R; Peterson, Eric D
2017-09-26
Intensive risk factor modification significantly improves outcomes for patients with diabetes mellitus and cardiovascular disease. However, the degree to which secondary prevention treatment goals are achieved in international clinical practice is unknown. Attainment of 5 secondary prevention parameters-aspirin use, lipid control (low-density lipoprotein cholesterol diabetes mellitus and known cardiovascular disease at entry into TECOS (Trial Evaluating Cardiovascular Outcomes With Sitagliptin). Logistic regression was used to evaluate the association between individual and regional factors and secondary prevention achievement at baseline. Cox proportional hazards regression analysis was used to determine the association between baseline secondary prevention achievement and cardiovascular death, myocardial infarction, or stroke. Overall, 29.9% of patients with diabetes mellitus and cardiovascular disease achieved all 5 secondary prevention parameters at baseline, although 71.8% achieved at least 4 parameters. North America had the highest proportion (41.2%), whereas Western Europe, Eastern Europe, and Latin America had proportions of ≈25%. Individually, blood pressure control (57.9%) had the lowest overall attainment, whereas nonsmoking status had the highest (89%). Over a median 3.0 years of follow-up, a higher baseline secondary prevention score was associated with improved outcomes in a step-wise graded relationship (adjusted hazard ratio, 0.60; 95% confidence interval, 0.47-0.77 for those patients achieving all 5 measures versus those achieving ≤2). In an international trial population, significant opportunities exist to improve the quality of cardiovascular secondary prevention care among patients with diabetes mellitus and cardiovascular disease, which in turn could lead to reduced risk of downstream cardiovascular events. URL: http://www.clinicaltrials.gov. Unique identifier: NCT00790205. © 2017 American Heart Association, Inc.
Prospective pilot study of a tablet computer in an Emergency Department.
Horng, Steven; Goss, Foster R; Chen, Richard S; Nathanson, Larry A
2012-05-01
The recent availability of low-cost tablet computers can facilitate bedside information retrieval by clinicians. To evaluate the effect of physician tablet use in the Emergency Department. Prospective cohort study comparing physician workstation usage with and without a tablet. 55,000 visits/year Level 1 Emergency Department at a tertiary academic teaching hospital. 13 emergency physicians (7 Attendings, 4 EM3s, and 2 EM1s) worked a total of 168 scheduled shifts (130 without and 38 with tablets) during the study period. Physician use of a tablet computer while delivering direct patient care in the Emergency Department. The primary outcome measure was the time spent using the Emergency Department Information System (EDIS) at a computer workstation per shift. The secondary outcome measure was the number of EDIS logins at a computer workstation per shift. Clinician use of a tablet was associated with a 38min (17-59) decrease in time spent per shift using the EDIS at a computer workstation (pcomputer was associated with a reduction in the number of times physicians logged into a computer workstation and a reduction in the amount of time they spent there using the EDIS. The presumed benefit is that decreasing time at a computer workstation increases physician availability at the bedside. However, this association will require further investigation. Copyright © 2011 Elsevier Ireland Ltd. All rights reserved.