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Standardization of Blood Growth Hormone Levels Measured by Different Kits Using a Linear Structural Relationship

Saito, Tomohiro; Tachibana, Katsuhiko; Shimatsu, Akira; Katsumata, Noriyuki; Hizuka, Naomi; Fujieda, Kenji; Yokoya, Susumu; Tanaka, Toshiaki
Fonte: The Japanese Society for Pediatric Endocrinology Publicador: The Japanese Society for Pediatric Endocrinology
Tipo: Artigo de Revista Científica
EN
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Accurate and reliable determination of blood growth hormone level is essential in the diagnosis and treatment of short stature children. However, measured levels differed considerably among measurement kits available in Japan until 2003. Therefore, standardization of the measured values was attempted by measuring growth hormone levels in a sample of healthy adult individuals every year using the different kits. A standardization equation was developed for each kit through linear structural relationship with the mean values of the used kits and measured values in each kit as random variables. A Pearson’s correlation coefficient between the mean values of all kits and the measured values from each kit was also obtained. Sources for the marked discrepancies amongst the measured values in the different kits were also explored. The obtained values for slopes and intercepts in the equations varied considerably, but the standard values obtained from these equations after the measured values for each kit were transformed into standard values served well as the standard. The standard solutions in the respective measurement kits were found to be the source of variability in the measured values among the kits.

Current Status of Standardization of Inhalant Allergen Extracts in Korea

Jeong, Kyoung Yong; Lee, Jae-Hyun; Kim, Eun-Jin; Lee, Joo-Shil; Cho, Sang-Heon; Hong, Soo-Jong; Park, Jung-Won
Fonte: The Korean Academy of Asthma, Allergy and Clinical Immunology; The Korean Academy of Pediatric Allergy and Respiratory Disease Publicador: The Korean Academy of Asthma, Allergy and Clinical Immunology; The Korean Academy of Pediatric Allergy and Respiratory Disease
Tipo: Artigo de Revista Científica
EN
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Allergy diagnosis and immunotherapy in Korea rely mostly on imported allergen extracts. However, some allergens that are not important in Western countries are not commercially available, and even the same species of allergen source often displays differences in allergenicity due to amino acid sequence polymorphisms. Therefore, it is essential to prepare allergen extracts that reflect regional characteristics. Allergen standardization has been performed since 2009 with the support of the Korea Center for Disease Control and Prevention. Here, we summarize the current status of allergen standardization, focusing on the house dust mite and cockroach. Pollen allergens that are under investigation are also briefly described.

Biological and Chemical Standardization of a Hop (Humulus lupulus) Botanical Dietary Supplement

Krause, Elizabeth; Yuan, Yang; Hajirahimkhan, Atieh; Dong, Huali; Dietz, Birgit M.; Nikolic, Dejan; Pauli, Guido F.; Bolton, Judy L.; van Breemen, Richard B.
Fonte: PubMed Publicador: PubMed
Tipo: Artigo de Revista Científica
Publicado em /06/2014 EN
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Concerned about the safety of conventional estrogen replacement therapy, women are using botanical dietary supplements as alternatives for the management of menopausal symptoms such as hot flashes. Before botanical dietary supplements can be evaluated clinically for safety and efficacy, botanically authenticated and standardized forms are required. To address the demand for a standardized, estrogenic botanical dietary supplement, an extract of hops (Humulus lupulus, L.) was developed. Although valued in the brewing of beer, hop extracts are used as anxiolytics and hypnotics and have well established estrogenic constituents. Starting with a hop cultivar used in the brewing industry, spent hops (the residue remaining after extraction of bitter acids) were formulated into a botanical dietary supplement that was then chemically and biologically standardized. Biological standardization utilized the estrogen dependent induction of alkaline phosphatase in the Ishikawa cell line. Chemical standardization was based on the prenylated phenols in hops that included estrogenic 8-prenylnaringenin (8-PN), its isomer 6-prenylnaringenin (6-PN), and pro-estrogenic isoxanthohumol (IX) and its isomeric chalcone xanthohumol (XN), all of which were measured using high performance liquid chromatography-tandem mass spectrometry (LC/MS-MS). The product of this process was a reproducible botanical extract suitable for subsequent investigations of safety and efficacy.

EUCAST Testing of Isavuconazole Susceptibility in Aspergillus: Comparison of Results for Inoculum Standardization Using Conidium Counting versus Optical Density

Arendrup, Maiken Cavling; Howard, Susan; Lass-Flörl, Cornelia; Mouton, Johan W.; Meletiadis, Joseph; Cuenca-Estrella, Manuel
Fonte: American Society for Microbiology Publicador: American Society for Microbiology
Tipo: Artigo de Revista Científica
Publicado em /11/2014 EN
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The EUCAST E.DEF9.1 standard recommends standardization of the inoculum concentration by conidium counting using a hemocytometer rather than a spectrophotometer. In this study, we investigated whether the choice of these methods influenced isavuconazole MICs. A blinded collection of 30 molecularly characterized azole-resistant isolates and 10 wild-type Aspergillus fumigatus isolates was shared with four different laboratories. Additionally, each laboratory selected approximately 100 A. fumigatus isolates and 50 isolates each of A. flavus, A. nidulans, A. niger, and A. terreus (1,237 isolates in total). Three laboratories (laboratories 1 to 3) used conidium counting. One laboratory standardized the inoculum using a spectrophotometer (that is, by use of the optical density [OD]) and is referred to as the OD laboratory. Correlation coefficients, intraclass correlation coefficients, and essential agreement were calculated, and 2-log-unit differences were assessed (paired t test). The MIC range for the blinded collection was 0.25 to 16 mg/liter, and a 1-dilution-step difference between the MIC50 and MIC90 across the four laboratories was detected and a 2-dilution-step difference between the modal MICs was detected. Compared to the results for laboratories 1 and 2...

Improving Collaboration by Standardization Efforts in Systems Biology

Dräger, Andreas; Palsson, Bernhard Ø.
Fonte: Frontiers Media S.A. Publicador: Frontiers Media S.A.
Tipo: Artigo de Revista Científica
Publicado em 08/12/2014 EN
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Collaborative genome-scale reconstruction endeavors of metabolic networks would not be possible without a common, standardized formal representation of these systems. The ability to precisely define biological building blocks together with their dynamic behavior has even been considered a prerequisite for upcoming synthetic biology approaches. Driven by the requirements of such ambitious research goals, standardization itself has become an active field of research on nearly all levels of granularity in biology. In addition to the originally envisaged exchange of computational models and tool interoperability, new standards have been suggested for an unambiguous graphical display of biological phenomena, to annotate, archive, as well as to rank models, and to describe execution and the outcomes of simulation experiments. The spectrum now even covers the interaction of entire neurons in the brain, three-dimensional motions, and the description of pharmacometric studies. Thereby, the mathematical description of systems and approaches for their (repeated) simulation are clearly separated from each other and also from their graphical representation. Minimum information definitions constitute guidelines and common operation protocols in order to ensure reproducibility of findings and a unified knowledge representation. Central database infrastructures have been established that provide the scientific community with persistent links from model annotations to online resources. A rich variety of open-source software tools thrives for all data formats...

Standardization of Relative Cerebral Blood Volume (rCBV) Image Maps for Ease of Both Inter- and Intrapatient Comparisons

Bedekar, Devyani; Jensen, Todd; Schmainda, Kathleen M.
Fonte: PubMed Publicador: PubMed
Tipo: Artigo de Revista Científica
Publicado em /09/2010 EN
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Relative cerebral blood volume (rCBV) measured using dynamic susceptibility contrast MRI suffers from interpatient and interstudy variability for the same tissue type. Traditionally, when a more quantitative assessment of rCBV is required, as for comparison across studies and patients, the rCBV values are normalized to the rCBV in a reference region such as normal-appearing white matter. However, this technique of normalization is subjective and time consuming and introduces user-dependent variability. In this study, we demonstrate that a method called standardization, applied to rCBV maps, is an objective means of translating all rCBV values to a consistent scale. This approach reduces interpatient and interstudy variability for the same tissue type, thus enabling easy and accurate visual and quantitative comparison across studies. One caveat to this approach is that it is not appropriate for the evaluation of global changes in blood volume, since systematic differences are removed in the process of standardization.

Quantitative Analysis of Torso FDG-PET Scans by Using Anatomical Standardization of Normal Cases from Thorough Physical Examinations

Hara, Takeshi; Kobayashi, Tatsunori; Ito, Satoshi; Zhou, Xiangrong; Katafuchi, Tetsuro; Fujita, Hiroshi
Fonte: Public Library of Science Publicador: Public Library of Science
Tipo: Artigo de Revista Científica
Publicado em 28/05/2015 EN
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Understanding of standardized uptake value (SUV) of 2-deoxy-2-[18F]fluoro-d-glucose positron emission tomography (FDG-PET) depends on the background accumulations of glucose because the SUV often varies the status of patients. The purpose of this study was to develop a new method for quantitative analysis of SUV of FDG-PET scan images. The method included an anatomical standardization and a statistical comparison with normal cases by using Z-score that are often used in SPM or 3D-SSP approach for brain function analysis. Our scheme consisted of two approaches, which included the construction of a normal model and the determination of the SUV scores as Z-score index for measuring the abnormality of an FDG-PET scan image. To construct the normal torso model, all of the normal images were registered into one shape, which indicated the normal range of SUV at all voxels. The image deformation process consisted of a whole body rigid registration of shoulder to bladder region and liver registration and a non-linear registration of body surface by using the thin-plate spline technique. In order to validate usefulness of our method, we segment suspicious regions on FDG-PET images manually, and obtained the Z-scores of the regions based on the corresponding voxels that stores the mean and the standard deviations from the normal model. We collected 243 (143 males and 100 females) normal cases to construct the normal model. We also extracted 432 abnormal spots from 63 abnormal cases (73 cancer lesions) to validate the Z-scores. The Z-scores of 417 out of 432 abnormal spots were higher than 2.0...

Avaliação de métodos de padronização dos pesos corporais às idades de 205, 365 e 550 dias.

LOBO, R. N. B.; MARTINS FILHO, R.
Fonte: Revista Brasileira de Zootecnia, Viçosa, MG, v. 31, n. 4, p. 1695-1706, 2002. Publicador: Revista Brasileira de Zootecnia, Viçosa, MG, v. 31, n. 4, p. 1695-1706, 2002.
Tipo: Artigo em periódico indexado (ALICE)
PT_BR
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Resumo: Foram comparados métodos de padronização dos pesos corporais às idades de 205, 365 e 550 dias. Utilizaram-se informações de animais da raça Nelore, criados na região Nordeste e controlados pela Associação Brasileira dos Criadores de Zebu (ABCZ). Compararam-se os métodos: METI - utilizado pela ABCZ; MET2 - curvas individuais de regressão linear para cada animal; MET3 - curvas individuais de regressão quadrática; MET4 - curvas individuais de Brody; MET5 - utilizado pelo Programa de Melhoramento Genético da Raça Nelore (PMGRN); e MET6 - curvas individuais de Richards. Houve diferenças entre as médias dos pesos corporais calculadas pelos diferentes métodos. Foram verificadas altas correlações entre os métodos. As estimativas de variâncias e de parâmetros genéticos foram diferentes entre os métodos. Os métodos em execução no Brasil apresentam diferenças quanto à sua aproximação em representar a curva de crescimento dos animais. Apesar das altas correlações genéticas e de classificação dos animais por seus valores genéticos, as diferenças nesta classificação podem influenciar o processo de seleção e a resposta esperada à esta seleção. Evaluation of body weight standardization methods for 205...

Establishment and validation of analytical reference panels for the standardization of quantitative BCR-ABL1 measurements on the international scale

White, H.; Hedges, J.; Bendit, I.; Branford, S.; Colomer, D.; Hochhaus, A.; Hughes, T.; Kamel-Reid, S.; Kim, D.W.; Modur, V.; Muller, M.; Pagnano, K.; Pane, F.; Radich, J.; Cross, N.; Labourier, E.
Fonte: Amer Assoc Clinical Chemistry Publicador: Amer Assoc Clinical Chemistry
Tipo: Artigo de Revista Científica
Publicado em //2013 EN
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BACKGROUND: Current guidelines for managing Philadelphia-positive chronic myeloid leukemia include monitoring the expression of the BCR-ABL1 (breakpoint cluster region/c-abl oncogene 1, non-receptor tyrosine kinase) fusion gene by quantitative reverse-transcription PCR (RT-qPCR). Our goal was to establish and validate reference panels to mitigate the interlaboratory imprecision of quantitative BCR-ABL1 measurements and to facilitate global standardization on the international scale (IS). METHODS: Four-level secondary reference panels were manufactured under controlled and validated processes with synthetic Armored RNA Quant molecules (Asuragen) calibrated to reference standards from the WHO and the NIST. Performance was evaluated in IS reference laboratories and with non–IS-standardized RT-qPCR methods. RESULTS: For most methods, percent ratios for BCR-ABL1 e13a2 and e14a2 relative to ABL1 or BCR were robust at 4 different levels and linear over 3 logarithms, from 10% to 0.01% on the IS. The intraassay and interassay imprecision was <2-fold overall. Performance was stable across 3 consecutive lots, in multiple laboratories, and over a period of 18 months to date. International field trials demonstrated the commutability of the reagents and their accurate alignment to the IS within the intra- and interlaboratory imprecision of IS-standardized methods. CONCLUSIONS: The synthetic calibrator panels are robust...

European Standardization and SDR certification

BALDINI Gianmarco; SYMEONIDIS Dimitrios
Fonte: IEEE Computer Society Publicador: IEEE Computer Society
Tipo: Contributions to Conferences Formato: CD-ROM
ENG
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Standardization and certification of Software Defined Radio (SDR) technologies are closely related. The paper describes the current standardization efforts for SDR technologies in Europe and the related certification processes. The regulatory and technical requirements for the certification of SDR and its components are defined in this paper. The paper presents the study on the development of a European SDR certification procedure through a network approach. Finally, we describe the Waveform Libraries and Issue Tracking System, which are an essential part of the certification process. The output of this study is a comprehensive overview of the certification; JRC.DG.G.6-Security technology assessment

Report of the IFCC Working Group for Standardization of Thyroid Function Tests - Part 3: Total Thyroxine and Total Triiodothyronine

THIENPONT Linda; VAN UYTFANGHE Katleen; BEASTALL Graham; FAIX James D.; IEIRI Tamio; MILLER W. Greg; NELSON Jerald C.; RONIN Catherine; ROSS H. Alec; THIJSSEN Jos H; TOUSSAINT Brigitte
Fonte: AMER ASSOC CLINICAL CHEMISTRY Publicador: AMER ASSOC CLINICAL CHEMISTRY
Tipo: Articles in Journals Formato: Printed
ENG
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BACKGROUND: Because total thyroid hormone testing is performed on many automated clinical chemistry instruments, the IFCC Scientific Division commissioned the Working Group for Standardization of Thyroid Function Tests to include total thyroxine (TT4) and total triiodothyronine (TT3) in its standardization efforts. METHODS: Existing SI-traceable reference measurement procedures (RMPs) were used to assign TT4 and TT3 values to 40 single-donor serum samples for subsequent use in amethod comparison study with 11 TT4 and 12 TT3 immunoassays. Data from comparison of each immunoassay with the RMPs provided a basis for mathematical assay recalibration. RESULTS: Seven TT4 assays had a mean bias within 10% of the RMP, but 2 deviated by an average of -12% and another 2 by +17%. All TT3 assays showed positive biases, 4 within and 8 outside 10%, up to 32%. Mathematical recalibration effectively eliminated assay-specific biases, but sample-related effects remained, particularly for TT3. Correlation coefficients with the RMPs ranged from 0.82 to 0.97 for TT4 and from 0.32 to 0.92 for TT3. The within-run and total imprecision ranges for TT4 were 1.4% to 9.1% and 3.0% to 9.4%, respectively, and for TT3 2.1% to 7.8% and 2.8% to 12.7%, respectively. Approximately one-half of the assays matched the internal QC targets within approximately 5%; however...

Evolution of cognitive radio technology in Europe: Regulatory and standardization aspects

BALDINI Gianmarco; HOLLAND Oliver; STAVROULAKI Vera; TSAGKARIS Kostas; DEMESTICHAS Panagiotis; POLYDOROS Andreas; KARANASIOS Stan; ALLEN David
Fonte: ELSEVIER SCI LTD Publicador: ELSEVIER SCI LTD
Tipo: Articles in Journals Formato: Printed
ENG
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Cognitive radio (CR) is considered a promising technology that could provide important benefits in the telecommunication domain. In Europe, the number of research projects, standardization activities and public consultations by the European Commission and regulatory authorities testify to the growing interest in CR. The introduction of CR in the telecommunication market may require new regulations or changes to the way spectrum is licensed and the conditions under which it can be used. The concepts of CR can be applied to various operational scenarios, which are described in this paper. This paper identifies the main challenges for the deployment of CR technology in Europe, provides an overview of the activities by European regulatory and standardization bodies to address the identified challenges and describes a roadmap with potential actions to support the adoption of CR technology.; JRC.G.6-Security technology assessment

Standardization of autoantibody testing: a paradigm for serology in rheumatic diseases

MERONI Pierluigi; BIGGIOGGERO Martina; PIERANGELI Silvia; SHELDON Joanna; ZEGERS Ingrid; BORGHI Maria Orietta
Fonte: NATURE PUBLISHING GROUP Publicador: NATURE PUBLISHING GROUP
Tipo: Articles in Journals Formato: Printed
ENG
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Autoantibody measurement is an excellent tool to confirm the diagnosis of rheumatic autoimmune diseases. Hence, reliability and harmonization of autoantibody testing are essential, but these issues are still a matter of debate. Intrinsic variability in analytes and reagents as well as heterogeneity of the techniques are the main reasons for discrepancies in inter-laboratory variations and reporting of test results. This lack of reliability might be responsible for wrong or missed diagnoses, as well as additional costs due to assay repetition, unnecessary use of confirmatory tests and/or consequent diagnostic investigations. To overcome such issues, the standardization of autoantibody testing requires efforts on all aspects of the assays, including the definition of the analyte, the pre-analytical stages, the calibration method and the reporting of results. As part of such efforts, the availability of suitable reference materials for calibration and quality control would enable the development of a reliable reference system. Strong-positive sera from patients have been used as reference materials in most of the autoantibody assays for rheumatic diseases; however, antigen-affinity-purified immunoglobulin fractions or in some cases reliable monoclonal antibody preparations offer more adequate tools for standardization. Systematic assessments of reference materials are currently underway...

Evaluation of standardization capability of current cardiac troponin I assays by a correlation study: results of an IFCC pilot project

TATE Jilian; BUNK David; CHRISTENSON Robert; BARTH Julian; KATRUKHA Alexei; NOBLE James E.; SCHIMMEL Heinz; WANG Lili; PANTEGHINI M.
Fonte: WALTER DE GRUYTER GMBH Publicador: WALTER DE GRUYTER GMBH
Tipo: Articles in periodicals and books Formato: Printed
ENG
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Background: As a part of an International Federation of Clinical Chemistry and Laboratory Medicine (IFCC) project to prepare a commutable reference material for cardiac troponin I (cTnI), a pilot study evaluated current cTnI assays for measurement equivalence and their standardization capability. Methods: cTnI-positive samples collected from 90 patients with suspected acute myocardial infarction were assessed for method comparison by 16 cTnI commercial assays according to predefined testing protocols. Seven serum pools prepared from these samples were also assessed. Results: Each assay was assessed against median cTnI concentrations measured by 16 cTnI assays using Passing-Bablok regression analysis of 79 patient samples with values above each assay’s declared detection limit. We observed a 10-fold difference in cTnI concentrations for lowest to highest measurement results. After mathematical recalibration of assays, the between-assay variation for patient samples reduced on average from 40% to 22% at low cTnI concentration, 37%–20% at medium concentration, and 29%–14% at high concentration. The average reduction for pools was larger at 16%, 13% and 7% for low, medium and high cTnI concentrations, respectively. Overall, assays demonstrated negligible bias after recalibration (y-intercept: –1.4 to 0.3 ng/L); however...

Network-based localized IP mobility management: Proxy Mobile IPv6 and current trends in standardization

Bernardos, Carlos J.; Gramaglia, Marco; Contreras, Luis M.; Calderón, María; Soto, Ignacio
Fonte: ©JOWUA Publicador: ©JOWUA
Tipo: info:eu-repo/semantics/publishedVersion; info:eu-repo/semantics/article Formato: application/pdf
Publicado em /09/2010 ENG
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IP mobility support has been a hot topic over the last years, recently fostered by the role of IP in the evolution of the 3G mobile communication networks. Standardization bodies, namely IETF, IEEE and 3GPP are working on different aspects of the mobility aiming at improving the mobility experience perceived by users. Traditional IP mobility support mechanisms, Mobile IPv4 or Mobile IPv6, are based on the operation of the terminal to keep ongoing sessions despite the movement. The current trend is towards network-based solutions where mobility support is based on network operation. Proxy Mobile IPv6 is a promising specification that allows network operators to provide localized mobility support without relying on mobility functionality or configuration present in the mobile nodes, which greatly eases the deployment of the solution. This paper presents Proxy Mobile IPv6 and the different extensions that are been considered by the standardization bodies to enhance the basic protocol with interesting features needed to offer a richer mobility experience, namely, flow mobility, multicast and network mobility support.; European Community's Seventh Framework Program

El an??lisis de la normalizaci??n de los elementos de contenido de las leyendas y palabras clave de fotograf??as cient??ficas

Doucet, Anne-Vinciane
Fonte: Universidade de Granada Publicador: Universidade de Granada
Tipo: Artigo de Revista Científica
SPA
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Se analizan las leyendas y las palabras clave de fotograf??as cient??ficas sobre el medio ambiente de un banco de im??genes para determinar si existe normalizaci??n en el uso de sus elementos de contenido. Los objetivos espec??ficos son: establecer los elementos sem??nticos utilizados en las leyendas y su estructura, comprobar el nivel del vocabulario empleado en las leyendas y en las palabras clave as?? como las funciones de Jakobson utilizadas en la leyenda, analizar los niveles de Panofsky en las leyendas y palabras clave. En una primera parte se definen los modelos de Jakobson, Lasswell y Panofsky con vista a caracterizar los elementos de contenido y sus niveles de utilizaci??n. En segundo lugar, se explica c??mo utilizarlos para analizar la representaci??n documental de las fotograf??as. Por ??ltimo, se presentan los resultados con respecto a los elementos normalizados y no normalizados, tanto en la leyenda como en las palabras clave, teniendo en cuenta la influencia que pueden tener en el tema de las fotograf??as. Para concluir, se proponen algunas mejoras en relaci??n con la normalizaci??n de la representaci??n documental de las fotograf??as.; The legends and keywords of scientific photographs about environment from an image bank are analyzed...

Relatório médico em imagiologia: estudo de práticas de criação e uso

Felgueiras, Nídia Maria Lopes
Fonte: Instituto Politécnico do Porto. Escola Superior de Estudos Industriais e de Gestão Publicador: Instituto Politécnico do Porto. Escola Superior de Estudos Industriais e de Gestão
Tipo: Dissertação de Mestrado
Publicado em //2015 POR
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Dissertação de Mestrado em Informação Empresarial; Considerando como objeto de estudo o Relatório Médico em imagiologia, esta investigação encontra-se situada entre duas áreas do saber, a Ciência de Informação e as Ciências da Saúde (mais designadamente no âmbito da imagiologia). O Relatório Médico em imagiologia é um documento textual, físico e/ou digital, sigiloso, com caráter legal, que compreende informação médica relativa a um (ou vários) exame(s) médico(s) de um utente e que têm como principal objetivo fornecer dados/indicadores para o diagnóstico médico especializado. Com esta investigação, pretende-se posicionar o objeto de estudo, documentar a sua génese intelectual e material, refletir sobre todo o fluxo informacional do documento, revelar a importância das suas fases de produção e de normalização. Foram realizados levantamentos bibliográficos e abordagens reflexivas sobre a importância e produção do relatório médico, que depois foram cruzados com estudos de caso baseado em diferentes instituições, onde a experiência profissional do médico (produtor intelectual) e datilógrafo (produtor material) nos elucida sobre a temática apresentada e nos permitiu entender práticas e fluxos informacionais. No final do estudo analisamos o papel do datilógrafo como produtor material do relatório médico...

Methodological Standardization for the Preclinical Evaluation of Renal Sympathetic Denervation

Sakakura, Kenichi; Ladich, Elena; Edelman, Elazer R.; Markham, Peter; Stanley, James R.L.; Keating, John; Kolodgie, Frank D.; Virmani, Renu; Joner, Michael
Fonte: PubMed Publicador: PubMed
Tipo: Artigo de Revista Científica
EN
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Transcatheter ablation of renal autonomic nerves is a viable option for the treatment of resistent arterial hypertension; however, structured preclinical evaluation with standardization of analytical procedures remains a clear gap in this field. Here we discuss the topics relevant to the preclinical model for the evaluation of renal denervation (RDN) devices and report methodologies and criteria towards standardization of the safety and efficacy assessment, including histopathological evaluations of the renal artery, peri-arterial nerves, and associated peri-adventitial tissues. The preclinical swine renal artery model can be used effectively to assess both the safety and efficacy of RDN technologies. Assessment of the efficacy of RDN modalities primarily focuses on the determination of the depth of penetration of treatment-related injury (eg, necrosis) of the peri-arterial tissues and its relationship (ie, location and distance) and affect on the associated renal nerves and the correlation thereof with proxy biomarkers including renal norepinephrine concentrations and nerve-specific immunohistochemical stains (eg, tyrosine hydroxylase). The safety evaluation of RDN technologies involves assessing for adverse effects on tissues local to the site of treatment (ie...

Whose standard is it, anyway? How the tobacco industry determines the International Organization for Standardization (ISO) standards for tobacco and tobacco products

Bialous, S.; Yach, D.
Fonte: BMJ Group Publicador: BMJ Group
Tipo: Artigo de Revista Científica
Publicado em /06/2001 EN
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OBJECTIVE—To describe the extent of the tobacco industry involvement in establishing international standards for tobacco and tobacco products and the industry influence on the International Organization for Standardization (ISO).
METHODS—Analysis of tobacco industry documents made public as part of the settlement of the Minnesota Tobacco Trial and the Master Settlement Agreement. Search words included "ISO", "CORESTA", "Barclay", "compensation and machine smoking", "tar and nicotine deliveries", and the name of key players, in different combinations.
RESULTS—It is clear that the tobacco industry, through the Cooperation Centre for Scientific Research Relative to Tobacco (CORESTA), play a major role in determining the scientific evidence and suggesting the standards that are eventually adopted as international standards for tobacco and tobacco products in several areas, including the measurement of cigarette tar and nicotine yield.
CONCLUSIONS—ISO's tobacco and tobacco products standards are not adequate to guide tobacco products regulatory policies, and no health claims can be made based on ISO's tobacco products standards. There is an urgent need for tobacco control advocates and groups worldwide to be more involved with the work of the ISO...

Standardization of Clinical Skill Evaluation in Physical/Occupational Therapist Education –Effects of Introduction of an Education System Using OSCE–

Sakurai, Hiroaki; Kanada, Yoshikiyo; Sugiura, Yoshito; Motoya, Ikuo; Yamada, Masayuki; Tomita, Masao; Naka, Toru; Teranishi, Toshio; Tanabe, Shigeo; Tsujimura, Toru; Okanishi, Tetsuo
Fonte: The Society of Physical Therapy Science Publicador: The Society of Physical Therapy Science
Tipo: Artigo de Revista Científica
EN
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[Purpose] A major issue in physical/occupational therapist education is the improvement of students' clinical techniques. In this study, we introduced an education system using an Objective Structured Clinical Examination (OSCE), and made an attempt at standardization of its evaluation. [Subjects] The subjects were 227 students in the classes of 2008 to 2010 who enrolled at our university between 2004 and 2006, before the introduction of the education system using OSCE, and 221 students in the classes of 2011 to 2013 who enrolled between 2007 and 2009, after the introduction. [Methods] Performances in attitude and skills (performance in clinical training and OSCE) were compared between before and after the introduction of OSCE. OSCE results were compared between before and after clinical trainings at each OSCE Level; and the correlation of between performances in clinical training and OSCE was examined. [Results] Performances in OSCE and clinical training (attitude, skills) were improved by the introduction of the education system using OSCE, but no significant correlation was observed in the relationship between performances in OSCE and clinical training. [Conclusion] Further studies should be conducted aiming at the standardization of clinical skill evaluation in postgraduate education to establish an education system using OSCE.