WorldWideScience

Sample records for interlaboratory trial assessment

  1. Use of pJANUS-02-001 as a calibrator plasmid for Roundup Ready soybean event GTS-40-3-2 detection: an interlaboratory trial assessment.

    Science.gov (United States)

    Lievens, A; Bellocchi, G; De Bernardi, D; Moens, W; Savini, C; Mazzara, M; Van den Eede, G; Van den Bulcke, M

    2010-03-01

    Owing to the labelling requirements of food and feed products containing materials derived from genetically modified organisms, quantitative detection methods have to be developed for this purpose, including the necessary certified reference materials and calibrator standards. To date, for most genetically modified organisms authorized in the European Union, certified reference materials derived from seed powders are being developed. Here, an assessment has been made on the feasibility of using plasmid DNA as an alternative calibrator for the quantitative detection of genetically modified organisms. For this, a dual-target plasmid, designated as pJANUS-02-001, comprising part of a junction region of genetically modified soybean event GTS-40-3-2 and the endogenous soybean-specific lectin gene was constructed. The dynamic range, efficiency and limit of detection for the soybean event GTS-40-3-2 real-time quantitative polymerase chain reaction (Q-PCR) system described by Terry et al. (J AOAC Int 85(4):938-944, 2002) were shown to be similar for in house produced homozygous genomic DNA from leaf tissue of soybean event GTS-40-3-2 and for plasmid pJANUS-02-001 DNA backgrounds. The performance of this real-time Q-PCR system using both types of DNA templates as calibrator standards in quantitative DNA analysis was further assessed in an interlaboratory trial. Statistical analysis and fuzzy-logic-based interpretation were performed on critical method parameters (as defined by the European Network of GMO Laboratories and the Community Reference Laboratory for GM Food and Feed guidelines) and demonstrated that the plasmid pJANUS-02-001 DNA represents a valuable alternative to genomic DNA as a calibrator for the quantification of soybean event GTS-40-3-2 in food and feed products.

  2. Epizone: Interlaboratory Ring Trial to Compare Dna Transfection Efficiencies

    DEFF Research Database (Denmark)

    Dory, Daniel; Albina, Emmanuel; Kwiatek, Olivier

    of viruses by reverse genetics and/or generation of mutated viruses. A large number of transfection chemicals like calcium phospate, branched organic compounds, liposomes, cationic polymers etc. are available on the market which are used by different laboratories for different cell lines. To obtain...... an overview on the efficiencies of varying transfection procedures, an interlaboratory ring trial was initiated within EPIZONE theme 5. A total of 15 participitating laboratories from 7 member institutions received RK13 cells, plasmid DNA encoding firefly luciferase under the transcriptional control...... of the human cytomegalovirus major immediate early promoter, a specially developed lysis buffer and a detailed protocol. Transfected cells were harvested in the laboratories of the participants, frozen and sent to the FLI where both the luciferase activity and protein content of the individual samples were...

  3. Interlaboratory trial on the determination of the In Vitro iron dialysability from food

    NARCIS (Netherlands)

    Luten, J.; Crews, H.; Flynn, A.

    1996-01-01

    An in vitro method for the estimation of iron bioavailability was subjected to an interlaboratory trial. The method involved a simulated gastrointestinal digestion using pepsin for the gastric stage followed by pancreatin and bile salts for the intestinal stage. The proportion of iron diffused

  4. [Interlaboratory trials for quality assurance of breast cancer biomarkers in Germany].

    Science.gov (United States)

    Krusche, C A; von Wasielewski, R; Rüschoff, J; Fisseler-Eckhoff, A; Kreipe, H H

    2008-07-01

    In the age of personalized medicine, and in addition to typing and grading, breast cancer pathologists are now also involved in determining biomarkers such as steroid hormone receptors and Her-2, which are of the utmost importance in adjuvant therapy. In order to assure quality of these biomarker assays, external proficiency testing has been implemented in Germany. Since 2002 trials have been conducted annually, with up to 180 participating laboratories. More than 85% of all participants achieved good results in clearly negative and positive cases seen in daily practice. If at all, discordant results were observed in the rarer low steroid-hormone receptor expressing tumors and Her-2 borderline cases (2+). Regular participation in interlaboratory testing leads to significantly improved immunohistochemical results, particularly in these problematic cases. Tissue microarrays (TMA) with 20-24 different breast cancer samples including cell lines meant that a huge number of pathologists were challenged with identical samples, providing the prerequisite for comparability. Participation is recommended for pathology departments involved in the service for breast units. The organizational frame work of the trials is described here. The confidence of cooperating disciplines in breast cancer biomarkers assessed by pathologists will be fostered by external proficiency testing as presented here.

  5. Inter-laboratory agreement on embryo classification and clinical decision: Conventional morphological assessment vs. time lapse.

    Science.gov (United States)

    Martínez-Granados, Luis; Serrano, María; González-Utor, Antonio; Ortíz, Nereyda; Badajoz, Vicente; Olaya, Enrique; Prados, Nicolás; Boada, Montse; Castilla, Jose A

    2017-01-01

    The aim of this study is to determine inter-laboratory variability on embryo assessment using time-lapse platform and conventional morphological assessment. This study compares the data obtained from a pilot study of external quality control (EQC) of time lapse, performed in 2014, with the classical EQC of the Spanish Society for the Study of Reproductive Biology (ASEBIR) performed in 2013 and 2014. In total, 24 laboratories (8 using EmbryoScope™, 15 using Primo Vision™ and one with both platforms) took part in the pilot study. The clinics that used EmbryoScope™ analysed 31 embryos and those using Primo Vision™ analysed 35. The classical EQC was implemented by 39 clinics, based on an analysis of 25 embryos per year. Both groups were required to evaluate various qualitative morphological variables (cell fragmentation, the presence of vacuoles, blastomere asymmetry and multinucleation), to classify the embryos in accordance with ASEBIR criteria and to stipulate the clinical decision taken. In the EQC time-lapse pilot study, the groups were asked to determine, as well as the above characteristics, the embryo development times, the number, opposition and size of pronuclei, the direct division of 1 into 3 cells and/or of 3 into 5 cells and false divisions. The degree of agreement was determined by calculating the intra-class correlation coefficients and the coefficient of variation for the quantitative variables and the Gwet index for the qualitative variables. For both EmbryoScope™ and Primo Vision™, two periods of greater inter-laboratory variability were observed in the times of embryo development events. One peak of variability was recorded among the laboratories addressing the first embryo events (extrusion of the second polar body and the appearance of pronuclei); the second peak took place between the times corresponding to the 8-cell and morula stages. In most of the qualitative variables analysed regarding embryo development, there was almost

  6. Interlaboratory variability in the quantification of new generation antiepileptic drugs based on external quality assessment data.

    Science.gov (United States)

    Williams, John; Bialer, Meir; Johannessen, Svein I; Krämer, Günther; Levy, René; Mattson, Richard H; Perucca, Emilio; Patsalos, Philip N; Wilson, John F

    2003-01-01

    To assess interlaboratory variability in the determination of serum levels of new antiepileptic drugs (AEDs). Lyophilised serum samples containing clinically relevant concentrations of felbamate (FBM), gabapentin (GBP), lamotrigine (LTG), the monohydroxy derivative of oxcarbazepine (OCBZ; MHD), tiagabine (TGB), topiramate (TPM), and vigabatrin (VGB) were distributed monthly among 70 laboratories participating in the international Heathcontrol External Quality Assessment Scheme (EQAS). Assay results returned over a 15-month period were evaluated for precision and accuracy. The most frequently measured compound was LTG (65), followed by MHD (39), GBP (19), TPM (18), VGB (15), FBM (16), and TGB (8). High-performance liquid chromatography was the most commonly used assay technique for all drugs except for TPM, for which two thirds of laboratories used a commercial immunoassay. For all assay methods combined, precision was MHD, FBM, TPM, and LTG, close to 15% for GBP and VGB, and as high as 54% for TGB (p methods, except for TPM, for which gas chromatography showed poorer accuracy compared with immunoassay and gas chromatography-mass spectrometry. With the notable exception of TGB, interlaboratory variability in the determination of new AEDs was comparable to that reported with older-generation agents. Poor assay performance is related more to individual operators than to the intrinsic characteristics of the method applied. Participation in an EQAS scheme is recommended to ensure adequate control of assay variability in therapeutic drug monitoring.

  7. Inter-laboratory assessment of a prototype multiplex kit for determination of recent HIV-1 infection.

    Directory of Open Access Journals (Sweden)

    Kelly A Curtis

    Full Text Available BACKGROUND: Accurate and reliable laboratory-based assays are needed for estimating HIV-1 incidence from cross-sectional samples. We recently described the development of a customized, HIV-1-specific Bio-Plex assay that allows for the measurement of HIV-specific antibody levels and avidity to multiple analytes for improved HIV-1 incidence estimates. METHODS: To assess intra- and inter-laboratory assay performance, prototype multiplex kits were developed and evaluated by three distinct laboratories. Longitudinal seroconversion specimens were tested in parallel by each laboratory and kit performance was compared to that of an in-house assay. Additionally, the ability of the kit to distinguish recent from long-term HIV-1 infection, as compared to the in-house assay, was determined by comparing the reactivity of known recent (infected 12 months drug naïve specimens. RESULTS: Although the range of reactivity for each analyte varied between the prototype kit and in-house assay, a measurable distinction in reactivity between recent and long-term specimens was observed with both assays in all three laboratories. Additionally, kit performance was consistent between all three laboratories. The intra-assay coefficient of variation (CV, between sample replicates for all laboratories, ranged from 0.5% to 6.1%. The inter-laboratory CVs ranged from 8.5% to 21.3% for gp160-avidity index (a and gp120-normalized mean fluorescent intensity (MFI value (n, respectively. CONCLUSION: We demonstrate the feasibility of producing a multiplex kit for measuring HIV antibody levels and avidity, with the potential for improved incidence estimates based on multi-analyte algorithms. The availability of a commercial kit will facilitate the transfer of technology among diverse laboratories for widespread assay use.

  8. Inter-laboratory ring trial to evaluate real-time reverse transcription polymerase chain reaction methods used for detection of infectious pancreatic necrosis virus in Chile

    Directory of Open Access Journals (Sweden)

    David Tapia

    2017-07-01

    Conclusions: Overall, the ring trial showed high values of sensitivity and specificity, with some problems of repeatability and inter-laboratory variability. This last issue needs to be addressed in order to allow harmonized diagnostic of IPNV within the country. We recommend the use of the NRL methods as validated and reliable qRT-PCR protocols for the detection of IPNV.

  9. Porcine reproductive and respiratory syndrome virus: Interlaboratory ring trial to evaluate real-time reverse transcription polymerase chain reaction detection methods

    DEFF Research Database (Denmark)

    Wernike, Kerstin; Bonilauri, Paolo; Dauber, Malte

    2012-01-01

    To compare the real-time reverse transcription quantitative polymerase chain reaction (RT-qPCR) assays used for the diagnosis of Porcine reproductive and respiratory syndrome virus (PRRSV), a Europe-wide interlaboratory ring trial was conducted. A variety of PRRSV strains including North American...

  10. Development, Validation, and Interlaboratory Evaluation of a Quantitative Multiplexing Method To Assess Levels of Ten Endogenous Allergens in Soybean Seed and Its Application to Field Trials Spanning Three Growing Seasons.

    Science.gov (United States)

    Hill, Ryan C; Oman, Trent J; Wang, Xiujuan; Shan, Guomin; Schafer, Barry; Herman, Rod A; Tobias, Rowel; Shippar, Jeff; Malayappan, Bhaskar; Sheng, Li; Xu, Austin; Bradshaw, Jason

    2017-07-12

    As part of the regulatory approval process in Europe, comparison of endogenous soybean allergen levels between genetically engineered (GE) and non-GE plants has been requested. A quantitative multiplex analytical method using tandem mass spectrometry was developed and validated to measure 10 potential soybean allergens from soybean seed. The analytical method was implemented at six laboratories to demonstrate the robustness of the method and further applied to three soybean field studies across multiple growing seasons (including 21 non-GE soybean varieties) to assess the natural variation of allergen levels. The results show environmental factors contribute more than genetic factors to the large variation in allergen abundance (2- to 50-fold between environmental replicates) as well as a large contribution of Gly m 5 and Gly m 6 to the total allergen profile, calling into question the scientific rational for measurement of endogenous allergen levels between GE and non-GE varieties in the safety assessment.

  11. Interlaboratory comparison of four in vitro assays for assessing androgenic and antiandrogenic activity of environmental chemicals

    DEFF Research Database (Denmark)

    Körner, Wolfgang; Vinggaard, Anne; Terouanne, B.

    2004-01-01

    We evaluated and compared four in vitro assays to detect androgen agonists and antagonists in an international interlaboratory study. Laboratory 1 used a cell proliferation assay (assay 1) with human mammary carcinoma cells stably transfected with human androgen receptor. The other laboratories u...

  12. Development and inter-laboratory assessment of droplet digital PCR assays for multiplex quantification of 15 genetically modified soybean lines.

    Science.gov (United States)

    Košir, Alexandra Bogožalec; Spilsberg, Bjørn; Holst-Jensen, Arne; Žel, Jana; Dobnik, David

    2017-08-17

    Quantification of genetically modified organisms (GMOs) in food and feed products is often required for their labelling or for tolerance thresholds. Standard-curve-based simplex quantitative polymerase chain reaction (qPCR) is the prevailing technology, which is often combined with screening analysis. With the rapidly growing number of GMOs on the world market, qPCR analysis becomes laborious and expensive. Innovative cost-effective approaches are therefore urgently needed. Here, we report the development and inter-laboratory assessment of multiplex assays to quantify GMO soybean using droplet digital PCR (ddPCR). The assays were developed to facilitate testing of foods and feed for compliance with current GMO regulations in the European Union (EU). Within the EU, the threshold for labelling is 0.9% for authorised GMOs per ingredient. Furthermore, the EU has set a technical zero tolerance limit of 0.1% for certain unauthorised GMOs. The novel multiplex ddPCR assays developed target 11 GMO soybean lines that are currently authorised, and four that are tolerated, pending authorisation in the EU. Potential significant improvements in cost efficiency are demonstrated. Performance was assessed for the critical parameters, including limits of detection and quantification, and trueness, repeatability, and robustness. Inter-laboratory performance was also determined on a number of proficiency programme and real-life samples.

  13. Sample requirements and design of an inter-laboratory trial for radiocarbon laboratories

    NARCIS (Netherlands)

    Bryant, C; Carmi, [No Value; Cook, G; Gulliksen, S; Harkness, D; Heinemeier, J; McGee, E; Naysmith, P; Possnert, G; van der Plicht, H; van Strydonck, M; Carmi, Israel

    2000-01-01

    An on-going inter-comparison programme which is focused on assessing and establishing consensus protocols to be applied in the identification, selection and sub-sampling of materials for subsequent C-14 analysis is described. The outcome of the programme will provide a detailed quantification of the

  14. Use of latent class models to accommodate inter-laboratory variation in assessing genetic polymorphisms associated with disease risk

    Directory of Open Access Journals (Sweden)

    Walter Stephen D

    2008-08-01

    Full Text Available Abstract Background Researchers wanting to study the association of genetic factors with disease may encounter variability in the laboratory methods used to establish genotypes or other traits. Such variability leads to uncertainty in determining the strength of a genotype as a risk factor. This problem is illustrated using data from a case-control study of cervical cancer in which some subjects were independently assessed by different laboratories for the presence of a genetic polymorphism. Inter-laboratory agreement was only moderate, which led to a very wide range of empirical odds ratios (ORs with the disease, depending on how disagreements were treated. This paper illustrates the use of latent class models (LCMs and to estimate OR while taking laboratory accuracy into account. Possible LCMs are characterised in terms of the number of laboratory measurements available, and if their error rates are assumed to be differential or non-differential by disease status and/or laboratory. Results The LCM results give maximum likelihood estimates of laboratory accuracy rates and the OR of the genetic variable and disease, and avoid the ambiguities of the empirical results. Having allowed for possible measurement error in the expure, the LCM estimates of exposure – disease associations are typically stronger than their empirical equivalents. Also the LCM estimates exploit all the available data, and hence have relatively low standard errors. Conclusion Our approach provides a way to evaluate the association of a polymorphism with disease, while taking laboratory measurement error into account. Ambiguities in the empirical data arising from disagreements between laboratories are avoided, and the estimated polymorphism-disease association is typically enhanced.

  15. Toward an international standard for PCR-based detection of foodborne Escherichia coli O157: Validation of the PCR-based method in a multicenter interlaboratory trial

    DEFF Research Database (Denmark)

    Abdulmawjood, A.; Bulte, M.; Roth, S.

    2004-01-01

    . The concordance (reproducibility) was 85.0%, calculated from all positive inoculation levels. The concordance odds ratio (degree of interlaboratory variation calculated from all positive inoculation levels) was 1.58, indicating the robustness of the PCR method. Thus, the interlaboratory variation due to personnel......, reagents, minor temperature or pH fluctuations and, not least, thermal cyclers, did not affect the performance of the method, which is currently being considered as part of an international PCR standard....

  16. Inter-laboratory assessment of different digital PCR platforms for quantification of human cytomegalovirus DNA.

    Science.gov (United States)

    Pavšič, Jernej; Devonshire, Alison; Blejec, Andrej; Foy, Carole A; Van Heuverswyn, Fran; Jones, Gerwyn M; Schimmel, Heinz; Žel, Jana; Huggett, Jim F; Redshaw, Nicholas; Karczmarczyk, Maria; Mozioğlu, Erkan; Akyürek, Sema; Akgöz, Müslüm; Milavec, Mojca

    2017-04-01

    Quantitative PCR (qPCR) is an important tool in pathogen detection. However, the use of different qPCR components, calibration materials and DNA extraction methods reduces comparability between laboratories, which can result in false diagnosis and discrepancies in patient care. The wider establishment of a metrological framework for nucleic acid tests could improve the degree of standardisation of pathogen detection and the quantification methods applied in the clinical context. To achieve this, accurate methods need to be developed and implemented as reference measurement procedures, and to facilitate characterisation of suitable certified reference materials. Digital PCR (dPCR) has already been used for pathogen quantification by analysing nucleic acids. Although dPCR has the potential to provide robust and accurate quantification of nucleic acids, further assessment of its actual performance characteristics is needed before it can be implemented in a metrological framework, and to allow adequate estimation of measurement uncertainties. Here, four laboratories demonstrated reproducibility (expanded measurement uncertainties below 15%) of dPCR for quantification of DNA from human cytomegalovirus, with no calibration to a common reference material. Using whole-virus material and extracted DNA, an intermediate precision (coefficients of variation below 25%) between three consecutive experiments was noted. Furthermore, discrepancies in estimated mean DNA copy number concentrations between laboratories were less than twofold, with DNA extraction as the main source of variability. These data demonstrate that dPCR offers a repeatable and reproducible method for quantification of viral DNA, and due to its satisfactory performance should be considered as candidate for reference methods for implementation in a metrological framework.

  17. Predictive performance and inter-laboratory reproducibility in assessing eye irritation potential of water- and oil-soluble mixtures using the Short Time Exposure test method.

    Science.gov (United States)

    Abo, Takayuki; Hilberer, Allison; Behle-Wagner, Christine; Watanabe, Mika; Cameron, David; Kirst, Annette; Nukada, Yuko; Yuki, Takuo; Araki, Daisuke; Sakaguchi, Hitoshi; Itagaki, Hiroshi

    2018-04-01

    The Short Time Exposure (STE) test method is an alternative method for assessing eye irritation potential using Statens Seruminstitut Rabbit Cornea cells and has been adopted as test guideline 491 by the Organisation for Economic Co-operation and Development. Its good predictive performance in identifying the Globally Harmonized System (GHS) No Category (NC) or Irritant Category has been demonstrated in evaluations of water-soluble substances, oil-soluble substances, and water-soluble mixtures. However, the predictive performance for oil-soluble mixtures was not evaluated. Twenty-four oil-soluble mixtures were evaluated using the STE test method. The GHS NC or Irritant Category of 22 oil-soluble mixtures were consistent with that of a Reconstructed human Cornea-like Epithelium (RhCE) test method. Inter-laboratory reproducibility was then confirmed using 20 water- and oil-soluble mixtures blind-coded. The concordance in GHS NC or Irritant Category among four laboratories was 90%-100%. In conclusion, the concordance in comparison with the results of RhCE test method using 24 oil-soluble mixtures and inter-laboratory reproducibility using 20 water- and oil-soluble mixtures blind-coded were good, indicating that the STE test method is a suitable alternative for predicting the eye irritation potential of both substances and mixtures. Copyright © 2018 Elsevier Ltd. All rights reserved.

  18. Advancing the Use of Passive Sampling in Risk Assessment and Management of Sediments Contaminated with Hydrophobic Organic Chemicals: Results of an International Ex Situ Passive Sampling Interlaboratory Comparison.

    Science.gov (United States)

    Jonker, Michiel T O; van der Heijden, Stephan A; Adelman, Dave; Apell, Jennifer N; Burgess, Robert M; Choi, Yongju; Fernandez, Loretta A; Flavetta, Geanna M; Ghosh, Upal; Gschwend, Philip M; Hale, Sarah E; Jalalizadeh, Mehregan; Khairy, Mohammed; Lampi, Mark A; Lao, Wenjian; Lohmann, Rainer; Lydy, Michael J; Maruya, Keith A; Nutile, Samuel A; Oen, Amy M P; Rakowska, Magdalena I; Reible, Danny; Rusina, Tatsiana P; Smedes, Foppe; Wu, Yanwen

    2018-03-20

    This work presents the results of an international interlaboratory comparison on ex situ passive sampling in sediments. The main objectives were to map the state of the science in passively sampling sediments, identify sources of variability, provide recommendations and practical guidance for standardized passive sampling, and advance the use of passive sampling in regulatory decision making by increasing confidence in the use of the technique. The study was performed by a consortium of 11 laboratories and included experiments with 14 passive sampling formats on 3 sediments for 25 target chemicals (PAHs and PCBs). The resulting overall interlaboratory variability was large (a factor of ∼10), but standardization of methods halved this variability. The remaining variability was primarily due to factors not related to passive sampling itself, i.e., sediment heterogeneity and analytical chemistry. Excluding the latter source of variability, by performing all analyses in one laboratory, showed that passive sampling results can have a high precision and a very low intermethod variability (sampling, irrespective of the specific method used, is fit for implementation in risk assessment and management of contaminated sediments, provided that method setup and performance, as well as chemical analyses are quality-controlled.

  19. High Interlaboratory Reproducibility and Accuracy of Next-Generation-Sequencing- Based Bacterial Genotyping in a Ring Trial

    NARCIS (Netherlands)

    Mellmann, Alexander; Andersen, Paal Skytt; Bletz, Stefan; Friedrich, Alexander W.; Kohl, Thomas A.; Lilje, Berit; Niemann, Stefan; Prior, Karola; Rossen, John W.; Harmsen, Dag

    Today, next-generation whole-genome sequencing (WGS) is increasingly used to determine the genetic relationships of bacteria on a nearly whole-genome level for infection control purposes and molecular surveillance. Here, we conducted a multicenter ring trial comprising five laboratories to determine

  20. Interlaboratory trial of the rat Pig-a mutation assay using an erythroid marker HIS49 antibody.

    Science.gov (United States)

    Kimoto, Takafumi; Horibata, Katsuyoshi; Chikura, Satsuki; Hashimoto, Kazuyuki; Itoh, Satoru; Sanada, Hisakazu; Muto, Shigeharu; Uno, Yoshifumi; Yamada, Masami; Honma, Masamitsu

    2013-08-15

    The peripheral blood Pig-a assay has shown promise as a tool for evaluating in vivo mutagenicity. In this study five laboratories participated in a collaborative trial that evaluated the transferability and reproducibility of a rat Pig-a assay that uses a HIS49 antibody reacts with an antigen found on erythrocytes and erythroid progenitors. In preliminary work, flow cytometry methods were established that enabled all laboratories to detect CD59-negative erythrocyte frequencies (Pig-a mutant frequencies) of laboratories (the in-life labs) then treated male rats with a single oral dose of N-nitroso-N-ethylurea, 7,12-dimethylbenz[a]anthracene (DMBA), or 4-nitroquinoline-1-oxide (4NQO). Blood samples were collected up to 4 weeks after the treatments and analyzed by flow cytometry for the frequency of CD59-negative cells among total red blood cells (RBCs; RBC Pig-a assay). RBC Pig-a assays were conducted in the four in-life laboratories, plus a fifth laboratory that received blood samples from the other laboratories. In addition, three of the five laboratories performed a Pig-a assay on reticulocytes (RETs; PIGRET assay), using blood from the rats treated with DMBA and 4NQO. The four in-life laboratories detected consistent, time- and dose-related increases in RBC Pig-a mutant frequency (MF) for all three test articles. Furthermore, comparable results were obtained in the fifth laboratory that received blood samples from other laboratories. The three laboratories conducting the PIGRET assay also detected consistent, time- and dose-related increases in Pig-a MF, with the RET MFs increasing more rapidly with time than RBC MFs. These results indicate that rat Pig-a assays using a HIS49 antibody were transferable between laboratories and that data generated by the assays were reproducible. The findings also suggest that the PIGRET assay may detect the in vivo mutagenicity of test compounds earlier than the RBC Pig-a assay. Copyright © 2013 Elsevier B.V. All rights reserved.

  1. Design and operation of an interlaboratory comparison scheme

    International Nuclear Information System (INIS)

    Voiculescu, R. M.; Olteanu, M. C.; Nistor, V. M.

    2013-01-01

    The competence of laboratories is assessed by two complementary techniques. One of the techniques is the on-site evaluation following the requirements of ISO/IEC 17025:2005. The other one implies the proficiency testing which involves the determination of laboratory performance by means of interlaboratory comparisons, whereby the laboratory performs practical tests and their results are further compared with those of other laboratories. The paper treats one of the most important topics of the proficiency testing – the interlaboratory comparison (ILC). There will be presented the need, the purpose and the main objectives of an ILC and also a typically situation where an interlaboratory comparison exercise (for radio-analytical methods) was planned. A fully description of the design and operation of an ILC scheme is the main purpose of this paper. A special attention will be given to the data analysis and evaluation of interlaboratory comparison scheme results. (authors)

  2. CIRP Interlaboratory Comparison

    DEFF Research Database (Denmark)

    De Chiffre, Leonardo; Hansen, Hans Nørgaard; Morace, Renata Erica

    An interlaboratory comparison on mechanical and optical coordinate measuring machines (CMMs) was organized by the Centre for Geometrical Metrology (CGM), Department of Manufacturing Engineering and Management (IPL), Technical University of Denmark (DTU) and carried out within Collège International...... be divided in two groups. A group leading to deviations larger than 2 µm, and a group with deviations that are comparable to those using mechanical machines. All but one laboratory could perform reversal measurements. Transfer of traceability was established as follows: 8 using gauge blocks, 2 laser...

  3. Limited interlaboratory comparison of Schmallenberg virus antibody detection in serum samples

    DEFF Research Database (Denmark)

    van der Poel, W. H. M.; Cay, B.; Zientara, S.

    2014-01-01

    Eight veterinary institutes in seven different countries in Europe participated in a limited interlaboratory comparison trial to evaluate laboratory performances of Schmallenberg virus (SBV) antibody detection in serum. Seven different sheep sera and three different cattle sera were circulated, a...

  4. Interlaboratory niobium dosimetry comparison

    International Nuclear Information System (INIS)

    Wille, P.

    1980-01-01

    For an interlaboratory comparison of neutron dosimetry using niobium the 93 sup(m)Nb activities of irradiated niobium monitors were measured. This work was performed to compare the applied techniques of dosimetry with Nb in different laboratories. The niobium monitors were irradiated in the fast breeder EBRII, USA and the BR2, Belgium. The monitors were dissolved and several samples were prepared. Their niobium contents were determined by the 94 Nb-count rates. since the original specific count rate was known. The KX radiations of the 93 sup(m)Nb of the samples and of a calibrated Nb-foil were compared. This foil was measured by PTB, Braunschweig and CBNM, Geel, which we additionally compared with the KX radiation of 88 Sr produced by a thin 88 Y source from a 88 Y-standard solution (PTB). (orig.) [de

  5. ASSESSMENT OF INTERLABORATORY PRETREATMENT PROTOCOLS BY RADIOCARBON DATING AN ELK BONE FOUND BELOW LAACHER SEE TEPHRA AT MIESENHEIM IV (RHINELAND, GERMANY)

    NARCIS (Netherlands)

    Fiedel, Stuart J.; Southon, John R.; Taylor, R. E.; Kuzmin, Yaroslav V.; Street, Martin; Higham, Thomas F. G.; van der Plicht, Johannes; Nadeau, Marie-Josee; Nalawade-Chavan, Shweta; Hatté, C.; Jull, A.J.T.

    2013-01-01

    Four accelerator mass spectrometry (AMS) facilities undertook an interlaboratory exercise designed to examine the reliability and reproducibility of radiocarbon determinations on bone by dating a sample of elk (Alces alces) from Miesenheim IV. This specimen is derived from a secure geological

  6. Assessing variability in chemical acute toxicity of unionid mussels: Influence of intra- and inter-laboratory testing, life stage, and species - SETAC Abstract

    Science.gov (United States)

    We developed a toxicity database for unionid mussels to examine the extent of intra- and inter-laboratory variability in acute toxicity tests with mussel larvae (glochidia) and juveniles; the extent of differential sensitivity of the two life stages; and the variation in sensitiv...

  7. Assessing variability in chemical acute toxicity of unionid mussels: Influence of intra- and inter-laboratory testing, life stage, and species

    Science.gov (United States)

    The authors developed a toxicity database for unionid mussels to examine the extent of intra- and interlaboratory variability in acute toxicity tests with mussel larvae (glochidia) and juveniles; the extent of differential sensitivity of the 2 life stages; and the variation in se...

  8. Interlaboratory evaluation of a cow's milk allergy mouse model to assess the allergenicity of hydrolysed cow's milk based infant formulas

    NARCIS (Netherlands)

    Esch, B.C.A.M. van; Bilsen, J.H.M. van; Jeurink, P.V.; Garssen, J.; Penninks, A.H.; Smit, J.J.; Pieters, R.H.H.; Knippels, L.M.J.

    2013-01-01

    This study describes two phases of a multi-phase project aiming to validate a mouse model for cow's milk allergy to assess the potential allergenicity of hydrolysed cow's milk based infant formulas (claim support EC-directive 2006/141/E). The transferability and the discriminatory power of this

  9. An interlaboratory study of the reproducibility and relevance of Episkin, a reconstructed human epidermis, in the assessment of cosmetics irritancy.

    Science.gov (United States)

    Roguet, R; Cohen, C; Robles, C; Courtellemont, P; Tolle, M; Guillot, J P; Pouradier Duteil, X

    1998-06-01

    Reconstructed epidermal models are particularly suited to assessing the tolerance of cosmetic and dermatological products in vitro. Their production in kit form makes them available for screening both raw ingredients and finished products since a large amount of material can be tested whatever their physicochemical properties. However, two conditions must first be fulfilled: they must give reproducible results and be relevant to data obtained in vivo. We tested the reproducibility of data obtained using the Episkin(R) model [cytotoxicity evaluated by the MTT conversion and the release of one of the most active proinflammatory mediator, interleukin 1alpha(ILalpha)] on different batches and in various research laboratories. After topical application of sodium dodecyl sulfate (SDS) the overall variability of the IC(50) results was 14% of the mean value. Within a given centre and a given batch, the coefficient of variation attributable to the dispersion between kits was 6% for the SDS IC(50) determination and 7% for IL1alpha release measurement. The results obtained with Episkin were then compared with data from primary human skin irritancy testing (48-hr occlusion test and clinical assessment) and rabbit irritancy evaluation (Draize cutaneous test). Analysis of the results obtained with 38 cosmetic products (oils, gels, emulsions, mascaras and shaving foam, including 19 irritants) revealed good concordance with data obtained in humans. Considering the release of IL1alpha as in vitro parameter, the test sensitivity, specificity and concordance were 68, 79 and 74%, respectively.

  10. Interlaboratory variability of Ki67 staining in breast cancer

    NARCIS (Netherlands)

    Focke, Cornelia M.; Bürger, Horst; van Diest, Paul J.; Finsterbusch, Kai; Gläser, Doreen; Korsching, Eberhard; Decker, Thomas; Anders, M.; Bollmann, R.; Eiting, Fr; Friedrich, K.; Habeck, J. O.; Haroske, G.; Hinrichs, B.; Behrens, A.; Krause, Lars Udo; Braun-Lang, U.; Lorenzen, J.; Minew, N.; Mlynek-Kersjes, M.; Nenning, H.; Packeisen, J.; Poche-de Vos, F.; Reyher-Klein, S.; Rothacker, D.; Schultz, M.; Sturm, U.; Tawfik, M.; Berghäuser, K. H.; Böcker, W; Cserni, G.; Habedank, S.; Lax, S.; Moinfar, F.; Regitnig, P.; Reiner-Concin, A.; Rüschoff, J.; Varga, Z.; Woziwodski, J.

    2017-01-01

    Background Postanalytic issues of Ki67 assessment in breast cancers like counting method standardisation and interrater bias have been subject of various studies, but little is known about analytic variability of Ki67 staining between pathology labs. Our aim was to study interlaboratory variability

  11. The distribution of interlaboratory comparison data

    DEFF Research Database (Denmark)

    Heydorn, Kaj

    2008-01-01

    The distribution of mutually consistent results from interlaboratory comparisons is expected to be leptokurtic, and readers are warned against accepting conclusions based on simulations assuming normality.......The distribution of mutually consistent results from interlaboratory comparisons is expected to be leptokurtic, and readers are warned against accepting conclusions based on simulations assuming normality....

  12. Interlaboratory toxicology data base

    International Nuclear Information System (INIS)

    Watson, C.R.

    1988-01-01

    The goal of this project is to provide investigators with the capability to assess experimentally derived dose-effect data from many laboratories for evaluating potential insults to human health. Initial efforts, reported here, concentrate on the beagle dog life span health-effects studies supported by DOE at five laboratories. Significant steps include standardization of the medical observation glossary, development of an independent off site data tape archive, and preliminary design of a registry to contain common-format dosimetric estimates and histopathologic observations for each major tissue in the more than 5000 dogs under study

  13. OECD validation study to assess intra- and inter-laboratory reproducibility of the zebrafish embryo toxicity test for acute aquatic toxicity testing.

    Science.gov (United States)

    Busquet, François; Strecker, Ruben; Rawlings, Jane M; Belanger, Scott E; Braunbeck, Thomas; Carr, Gregory J; Cenijn, Peter; Fochtman, Przemyslaw; Gourmelon, Anne; Hübler, Nicole; Kleensang, André; Knöbel, Melanie; Kussatz, Carola; Legler, Juliette; Lillicrap, Adam; Martínez-Jerónimo, Fernando; Polleichtner, Christian; Rzodeczko, Helena; Salinas, Edward; Schneider, Katharina E; Scholz, Stefan; van den Brandhof, Evert-Jan; van der Ven, Leo T M; Walter-Rohde, Susanne; Weigt, Stefan; Witters, Hilda; Halder, Marlies

    2014-08-01

    The OECD validation study of the zebrafish embryo acute toxicity test (ZFET) for acute aquatic toxicity testing evaluated the ZFET reproducibility by testing 20 chemicals at 5 different concentrations in 3 independent runs in at least 3 laboratories. Stock solutions and test concentrations were analytically confirmed for 11 chemicals. Newly fertilised zebrafish eggs (20/concentration and control) were exposed for 96h to chemicals. Four apical endpoints were recorded daily as indicators of acute lethality: coagulation of the embryo, lack of somite formation, non-detachment of the tail bud from the yolk sac and lack of heartbeat. Results (LC50 values for 48/96h exposure) show that the ZFET is a robust method with a good intra- and inter-laboratory reproducibility (CV30%) for some very toxic or volatile chemicals, and chemicals tested close to their limit of solubility. The ZFET is now available as OECD Test Guideline 236. Considering the high predictive capacity of the ZFET demonstrated by Belanger et al. (2013) in their retrospective analysis of acute fish toxicity and fish embryo acute toxicity data, the ZFET is ready to be considered for acute fish toxicity for regulatory purposes. Copyright © 2014 The Authors. Published by Elsevier Inc. All rights reserved.

  14. Inter-laboratory assessment of PrPSc typing in creutzfeldt-jakob disease: a Western blot study within the NeuroPrion Consortium.

    Science.gov (United States)

    Parchi, Piero; Notari, Silvio; Weber, Petra; Schimmel, Heinz; Budka, Herbert; Ferrer, Isidre; Haik, Stéphane; Hauw, Jean-Jacques; Head, Mark W; Ironside, James W; Limido, Lucia; Rodriguez, Agustin; Ströbel, Thomas; Tagliavini, Fabrizio; Kretzschmar, Hans A

    2009-07-01

    Molecular typing is of considerable importance for the surveillance and epidemiology of human transmissible spongiform encephalopathies (TSEs). It relies on the detection of distinct protease-resistant prion protein (PrP(Sc)) core fragments that differ in molecular mass and/or glycoform ratio. In this collaborative study, we tested the inter-laboratory agreement in TSE molecular typing. Sixteen characterized brain specimens from sporadic TSEs and variant Creutzfeldt-Jakob disease (vCJD) cases were distributed blindly to seven laboratories for molecular characterization by a defined protocol and classification. Agreement between laboratories in the classification of samples was excellent. In particular, there were no differences in the distinction between PrP(Sc) type 1, type 2A, and type 2B with one exception, which eventually was identified as a case with types 1 and 2 co-occurrence. This shows that the general technique and particular classification system used here are robust and represent a reliable basis for diagnostic and epidemiologic purposes. The subtle further distinction of subtypes among type 1 and type 2 groups requires high-sensitivity gel electrophoresis protocols that are unsuitable for routine diagnostic needs and must be reserved for research investigations. Further research is necessary on the identification and significance of co-occurrence of PrP(Sc) types 1 and 2 within one brain.

  15. Predicting skin sensitization potential and inter-laboratory reproducibility of a human Cell Line Activation Test (h-CLAT) in the European Cosmetics Association (COLIPA) ring trials.

    Science.gov (United States)

    Sakaguchi, Hitoshi; Ryan, Cindy; Ovigne, Jean-Marc; Schroeder, Klaus R; Ashikaga, Takao

    2010-09-01

    Regulatory policies in Europe prohibited the testing of cosmetic ingredients in animals for a number of toxicological endpoints. Currently no validated non-animal test methods exist for skin sensitization. Evaluation of changes in cell surface marker expression in dendritic cell (DC)-surrogate cell lines represents one non-animal approach. The human Cell Line Activation Test (h-CLAT) examines the level of CD86 and CD54 expression on the surface of THP-1 cells, a human monocytic leukemia cell line, following 24h of chemical exposure. To examine protocol transferability, between-lab reproducibility, and predictive capacity, the h-CLAT has been evaluated by five independent laboratories in several ring trials (RTs) coordinated by the European Cosmetics Association (COLIPA). The results of the first and second RTs demonstrated that the protocol was transferable and basically had good between-lab reproducibility and predictivity, but there were some false negative data. To improve performance, protocol and prediction model were modified. Using the modified prediction model in the first and second RT, accuracy was improved. However, about 15% of the outcomes were not correctly identified, which exposes some of the limitations of the assay. For the chemicals evaluated, the limitation may due to chemical being a weak allergen or having low solubility (ex. alpha-hexylcinnamaldehyde). The third RT evaluated the modified prediction model and satisfactory results were obtained. From the RT data, the feasibility of utilizing cell lines as surrogate DC in development of in vitro skin sensitization methods shows promise. The data also support initiating formal pre-validation of the h-CLAT in order to fully understand the capabilities and limitations of the assay. Copyright 2010 Elsevier Ltd. All rights reserved.

  16. Interlaboratory Trial for Measurement of Vitamin D and 25-Hydroxyvitamin D [25(OH)D] in Foods and a Dietary Supplement Using Liquid Chromatography-Mass Spectrometry

    DEFF Research Database (Denmark)

    Roseland, Janet Maxwell; Patterson, Kristine Y; Andrews, Karen W

    2016-01-01

    performance has been needed. The primary goal of this study was to evaluate whether vitamin D3 and 25(OH)D3 concentrations in food and DS materials could be measured with acceptable reproducibility. Five experienced laboratories from the United States and other countries participated, all using liquid......Assessment of total vitamin D intake from foods and dietary supplements (DSs) may be incomplete if 25-hydroxyvitamin D [25(OH)D] intake is not included. However, 25(OH)D data for such intake assessments are lacking, no food or DS reference materials (RMs) are available, and comparison of laboratory...... chromatography tandem-mass spectrometry but no common analytical protocol; however, various methods were used for determining vitamin D3 in the DS. Five animal-based materials (including three commercially available RMs) and one DS were analyzed. Reproducibility results for the materials were acceptable. Thus...

  17. Interlaboratory Collaborations in the Undergraduate Setting

    Science.gov (United States)

    Megehee, Elise G.; Hyslop, Alison G.; Rosso, Richard J.

    2005-01-01

    A novel approach to cross-disciplinary and group learning, known as interlaboratory collaborations, was developed. The method mimics an industrial or research setting, fosters teamwork, and emphasizes the importance of good communication skills in the sciences.

  18. Dicentric assay: Inter-laboratory comparison in Indian laboratories for routine and triage applications

    International Nuclear Information System (INIS)

    Bakkiam, D.; Bhavani, M.; Anantha Kumar, A. Arul; Sonwani, Swetha; Venkatachalam, P.; Sivasubramanian, K.; Venkatraman, B.

    2015-01-01

    An Inter-Laboratory Comparison (ILC) study on Dicentric Chromosome Assay (DCA) was carried out between two Indian biodosimetry labs. Human peripheral blood samples exposed to 10 different doses of X-rays up to 5 Gy were shared between the labs to generate calibration data. Validation of calibration curves was done by dose estimation of coded samples exposed to X- or gamma radiation. Reliability of the DCA data for triage application was evaluated by scoring 20, 50 and 100 metaphases in the dose range of 0.5–3.0 Gy. No significant difference was observed between labs regarding the established calibration data as well as the DCA triage dose assessments. Scoring of 20 metaphases (MP) was adequate to detect radiation exposure of >2 Gy whereas 50 MP were sufficient to determine exposures of 0.5 Gy. Both labs performed the DCA in a reliable manner and made the first step in setting up a biodosimetry network in India. - Highlights: • This is the first Inter-Laboratory Comparison (ILC) study from India on Dicentric Chromosomal Assay (DCA) for both routine and triage biodosimetry applications. • No significant difference in the in vitro dose response curve parameters (slope, intercept and curvature) between labs. • Validation of calibration curves was done by blind trial method using samples exposed to different doses of X-rays and gamma rays. • Triage analysis was done by scoring 20, 50 and 100 metaphases for dose determination. • Scoring 20 metaphases is adequate to detect radiation exposure of 2 Gy and 50 metaphases is sufficient to determine radiation exposures of as low as 0.5 Gy. • The feasibility of formation of biodosimetry network in India which is essential especially when the country is aiming at capacity building in nuclear energy is demonstrated

  19. The Postoperative Pain Assessment Skills Pilot Trial

    Directory of Open Access Journals (Sweden)

    Michael McGillion

    2011-01-01

    Full Text Available BACKGROUND/OBJECTIVES: Pain-related misbeliefs among health care professionals (HCPs are common and contribute to ineffective postoperative pain assessment. While standardized patients (SPs have been effectively used to improve HCPs’ assessment skills, not all centres have SP programs. The present equivalence randomized controlled pilot trial examined the efficacy of an alternative simulation method – deteriorating patient-based simulation (DPS – versus SPs for improving HCPs’ pain knowledge and assessment skills.

  20. Statistical evaluation of an interlaboratory comparison for the determination of uranium by potentiometric titration

    International Nuclear Information System (INIS)

    Ketema, D.J.; Harry, R.J.S.; Zijp, W.L.

    1990-09-01

    Upon request of the ESARDA working group 'Low enriched uranium conversion - and fuel fabrication plants' an interlaboratory comparison was organized, to assess the precision and accuracy concerning the determination of uranium by the potentiometric titration method. This report presents the results of a statistical evaluation on the data of the first phase of this exercise. (author). 9 refs.; 5 figs.; 24 tabs

  1. Radiocarbon dating of interlaboratory check samples

    International Nuclear Information System (INIS)

    Blake, W.

    1983-01-01

    This note presents the results of a series of interlaboratory age determinations in which the Geological Survey of Canada's Radiocarbon Dating Laboratory has been involved. There is good agreement between laboratories, although there may be other problems related to the interpretation of individual samples

  2. Results of interlaboratory tests regarding TXRF

    International Nuclear Information System (INIS)

    Klockenkaemper, R.; Bohlen, A. von

    2000-01-01

    Interlaboratory or intercomparison tests can be performed for proficiency testing of individual laboratories, for the certification of a special sample material and for the validation of a certain method. We participated in two interlaboratory tests in order to validate total reflection x-ray fluorescence analysis (TXRF). We used our results to evaluate TXRF and to compare it with other competing methods, particularly with respect of precision and accuracy. The first interlaboratory test was organized by IAEA (International Atomic Energy Agency, Vienna, Austria). As a candidate for reference material, a lichen (IAEA-336 Lichen) was distributed among 27 participants. In our laboratory, the powdered biogenic material was digested with nitric acid under high pressure and analyzed by TXRF. - The second interlaboratory test was organized by IRMM (Institute for Reference Materials and Measurements, Geel, Belgium). As a certified test sample with undisclosed values, a sediment (IMEP-14) was delivered to 220 laboratories. We digested the geogenic material again by nitric acid and additionally by hydrofluoric acid and analyzed it by TXRF. - In both test samples, six or eight different trace elements, respectively, were determined by TXRF with a content between 2 and 2000 mg/kg. Calibration was carried out by internal standardization. For that purpose, Ga or Se, respectively, was added as standard element. The measurement uncertainty of TXRF was estimated by the method of error propagation. In our paper we will report on the results of the two interlaboratory tests. It will be shown that TXRF is highly reliable for a correct determination of trace elements in biogenic and geogenic samples. It is competitive with the established methods of trace analyses which were involved in these tests and it is even superior to them in certain aspects. (author)

  3. Reliability of mutagen sensitivity assay: an inter-laboratory comparison.

    Science.gov (United States)

    Erdei, Esther; Lee, Sang-Joon; Wei, Qingyi; Wang, Li-E; Song, Yan-S; Bovbjerg, Dana; Berwick, Marianne

    2006-07-01

    Mutagen sensitivity is regarded as a genetic susceptibility phenotype for various cancers; it is cytogenetically based and probably involves a number of genes from different DNA repair pathways. This assay has been used in a number of laboratories in the field of epidemiology, where it has been investigated and appears to be a useful susceptibility biomarker for epidemiological studies assessing cancer risks at the population level. One concern about phenotypic assays, such as the mutagen sensitivity assay, has been that there could be wide variation in results depending on the timing of the assay (within individual variation), the individual performing the assay (within observer variation) and the laboratory where the assay has been performed (inter-laboratory variation). We conducted an inter-laboratory comparison study between the Memorial Sloan-Kettering Cancer Center and M. D. Anderson, in which we assessed all these concerns. We did not find any significant variation in any of the assays. The correlation was high for all tests. The good concordance rate between laboratories supports the continued use of the mutagen sensitivity assay by different laboratories, and demonstrates its potential to identify at-risk subgroups among normal individuals and cancer patients alike.

  4. Analysis of Tomato Fruit: Effect of Frozen Storage on Compositional Values- an Inter-laboratory Study

    OpenAIRE

    Buret, Michel; Gormley, T. R. (Thomas Ronan); Roucoux, Pierre

    1983-01-01

    Tomato culturing trials often result in too many samples to analyse while fresh. The most common technique is to seal them in containers and preserve them by deepfreezing for subsequent analysis. An inter-laboratory study has been made of the effect of freezing for various lengths of time on a number of compositional factors. Tests for soluble solids, dry matter content, electrical conductivity, titratable acidity, potassium, pH, glucose, fructose, sucrose, total N and Vitamin C in frozen tom...

  5. Bioassay battery interlaboratory investigation of emerging contaminants in spiked water extracts e Towards the implementation of bioanalytical monitoring tools in water quality assessment and monitoring

    NARCIS (Netherlands)

    Di Paolo, C.; Ottermanns, R.; Keiter, S.; Ait-Aissa, S.; Bluhm, K.; Brack, W.; Breitholz, M.; Buchinger, S.; Carere, M.; Chalon, C.; Cousin, X.; Dulio, V.; Escher, B.I.; Hamers, T.; Jarque, S.; Jonas, A.; Maillot-Marechal, E.; Marneffe, Y.; Nguyen, M.T.; Pandard, P.; Schifferli, A.; Schulze, T.; Seidensticker, S.; Seiler, T.B.; Tang, J.; van der Oost, R.; Vermeirssen, E.; Zounková, R.; Zwart, N.; Hollert, H.

    2016-01-01

    Bioassays are particularly useful tools to link the chemical and ecological assessments in water quality monitoring. Different methods cover a broad range of toxicity mechanisms in diverse organisms, and account for risks posed by non-target compounds and mixtures. Many tests are already applied in

  6. Interlaboratory study of novel halogenated flame retardants: INTERFLAB.

    Science.gov (United States)

    Melymuk, Lisa; Goosey, Emma; Riddell, Nicole; Diamond, Miriam L

    2015-09-01

    Flame retardants (FRs) have come under considerable scientific and public scrutiny over the past decade. A lack of reference materials and standardized analytical methods has resulted in questions regarding the variation of measurements from different studies. We evaluated this variation by performing an international interlaboratory study assessing analytical capabilities as well as the accuracy and precision of results for a range of flame retardants (International Flame Retardant Laboratory Study, INTERFLAB). Thirteen international research laboratories participated in a blind interlaboratory comparison of 24 FRs. Results demonstrate good precision within replicates of test mixtures from individual laboratories, but problematic accuracy for several FRs and laboratories. Large ranges in the values reported for decabromodiphenylethane (DBDPE), tris(1,3-dichloropropyl)phosphate (TDCIPP), tetrabromobisphenol-A (TBBPA), and hexabromocyclododecane (HBCD) (>50 % relative standard deviations among measured values) and large deviations from the reference values (>25 % bias in accuracy) suggest potential problems for comparability of results. DBDPE, HBCD, and TBBPA had significantly poorer accuracy and precision, suggesting that current analytical methods are not providing reliable results for these FRs.

  7. Safety assessment of food and herbal products containing hepatotoxic pyrrolizidine alkaloids: interlaboratory consistency and the importance of N-oxide determination.

    Science.gov (United States)

    Cao, Yu; Colegate, Steven M; Edgar, John A

    2008-01-01

    Two recent mass spectrometry-based reports concerning Senecio scandens yielded remarkably dissimilar pyrrolizidine alkaloid constituents. In both studies, and in a related analysis of Senecio scandens and Tussilago farfara using micellar electrokinetic chromatography, the presence of hazardous N-oxides of the alkaloids was either not considered or was inadequately considered. This raises concerns about the effectiveness of the methodologies used in these, and similar, studies in assessing the pyrrolizidine alkaloid content and the safety of food, food supplements and medicines for human use. To highlight essential analytical requirements for confident assessment of pyrrolizidine alkaloid-related safety of food and herbal products for human use. Direct infusion-ESI MS and HPLC-ESI MS were used to analyse samples derived from liquid-liquid partitioning experiments and from strong cation exchange, solid-phase extraction of pyrrolizidine alkaloids and their N-oxides. A simple solvent partitioning experiment using pure senecionine and senecionine-N-oxide, two constituents reported in one of the mass spectrometry-based studies of S. scandens, clearly demonstrated the inadequacy of the reported method to detect and quantitate hazardous pyrrolizidine alkaloid N-oxide components. A preliminary LCMS analysis of commercially-prepared extracts of comfrey roots (Symphytum officinale and S. uplandicum s. l.) was used as a model to highlight the analytical importance of N-oxides in the safety assessment of pyrrolizidine alkaloid-containing medicinal herbs. This study highlighted significant differences in the reported identification of pyrrolizidine alkaloids from the same plant species, and clearly demonstrated the inadequacy of some procedures to include N-oxides in the assessment of pyrrolizidine alkaloid-related safety of food and herbal products.

  8. The North American Josephson Voltage Interlaboratory Comparison

    Energy Technology Data Exchange (ETDEWEB)

    Parks, Harold V. [Sandia National Laboratories (SNL-NM), Albuquerque, NM (United States); Tang, Yi-hua [National Inst. of Standards and Technology (NIST), Gaithersburg, MD (United States); Reese, Paul [Bionetics Corporation, Patrick Air Force Base, Brevard County, FL (United States); Gust, Jeff [Fluke Corporation, Everett, WA (United States); Novak, James J. [Sandia National Laboratories (SNL-NM), Albuquerque, NM (United States)

    2013-01-23

    The ninth North American Josephson voltage standard (JVS) interlaboratory comparison (ILC) at 10 V was completed in 2011. An on-site comparison was conducted between the National Institute of Standards and Technology compact JVS and the pivot laboratory system. A set of four traveling Zener voltage standards was then shipped from the pivot laboratory to the other participants. Here, we give the results from the 2011 ILC and review recent comparisons which have used the same traveling standards and similar procedures.

  9. An inter-laboratory comparison of urinary 3-hydroxypropylmercapturic acid measurement demonstrates good reproducibility between laboratories

    Directory of Open Access Journals (Sweden)

    Bailey Brian

    2011-10-01

    Full Text Available Abstract Background Biomarkers have been used extensively in clinical studies to assess toxicant exposure in smokers and non-smokers and have recently been used in the evaluation of novel tobacco products. The urinary metabolite 3-HPMA, a metabolite of the major tobacco smoke toxicity contributor acrolein, is one example of a biomarker used to measure exposure to tobacco smoke. A number of laboratories have developed liquid chromatography with tandem mass spectrometry (LC-MS/MS based methods to measure urinary 3-HPMA; however, it is unclear to what extent the data obtained by these different laboratories are comparable. Findings This report describes an inter-laboratory comparison carried out to evaluate the comparability of 3-HPMA measurement between four laboratories. A common set of spiked and authentic smoker and non-smoker urine samples were used. Each laboratory used their in-house LC-MS/MS method and a common internal standard. A comparison of the repeatability ('r', reproducibility ('R', and coefficient of variation for 3-HPMA demonstrated that within-laboratory variation was consistently lower than between-laboratory variation. The average inter-laboratory coefficient of variation was 7% for fortified urine samples and 16.2% for authentic urine samples. Together, this represents an inter-laboratory variation of 12.2%. Conclusion The results from this first inter-laboratory comparison for the measurement of 3-HPMA in urine demonstrate a reasonably good consensus between laboratories. However, some consistent measurement biases were still observed between laboratories, suggesting that additional work may be required to further reduce the inter-laboratory coefficient of variation.

  10. Interlaboratory comparison: Radionuclides in Irish sea water. IAEA-443

    International Nuclear Information System (INIS)

    2009-01-01

    Our society is giving increasing importance to the study and assessment of the state and health of the environment. Organizations involved in such activities rely on the quality of the information provided and, ultimately, on the precision and accuracy of the data on which the information is based. Many laboratories are involved in the production of environmental data, in many cases leading to wider assessments. These laboratories may develop and validate new analytical methods, study the environmental impact of human activities, provide services to other organizations, etc. In particular, laboratories are providing data on levels of radioactivity in a variety of marine matrixes such as water, suspended matter, sediments and biota. Because of the need to base scientific conclusions on valid and internationally comparable data, the need to provide policy makers with correct information and the need for society to be informed of the state of the environment, it is indispensable to ensure the quality of the data produced by each laboratory. Principles of good laboratory practice require both internal and external procedures to verify the quality of the data produced. Internal quality is verified in a number of ways, such as the use of laboratory information systems, keeping full records of equipment performance and standardization of analytical procedures. External quality can also be ascertained in a number of ways, notably accreditation by an external body under a defined quality scheme but also, amongst others, the use of internationally accepted calibration standards that are traceable to the SI international system of units, the participation in interlaboratory comparisons or the regular use of Reference Materials to test laboratory performance. The Radiometrics Laboratory of the International Atomic Energy Agency's Marine Environment Laboratories has been providing quality products for the last 40 years, which include the organization of interlaboratory

  11. Results from three years of the world's largest interlaboratory comparison for total mercury and methylmercury: Method performance and best practices

    Science.gov (United States)

    Creswell, J. E.; Engel, V.; Carter, A.; Davies, C.

    2013-12-01

    Brooks Rand Instruments has conducted the world's largest interlaboratory comparison study for total mercury and methylmercury in natural waters annually for three years. Each year, roughly 50 laboratories registered to participate and the majority of participants submitted results. Each laboratory was assigned a performance score based on the distance between its results and the consensus mean, as well as the precision of its replicate analyses. Participants were also asked to provide detailed data on their analytical methodology and equipment. We used the methodology data and performance scores to assess the performance of the various methods reported and equipment used. Although the majority of methods in use show no systematic trend toward poor analytical performance, there are noteworthy exceptions. We present results from each of the three years of the interlaboratory comparison exercise, as well as aggregated method performance data. We compare the methods used in this study to methods from other published interlaboratory comparison studies and present a list of recommended best practices. Our goals in creating a list of best practices are to maximize participation, ensure inclusiveness, minimize non-response bias, guarantee high data quality, and promote transparency of analysis. We seek to create a standardized methodology for interlaboratory comparison exercises for total mercury and methylmercury analysis in water, which will lead to more directly comparable results between studies. We show that in most cases, the coefficient of variation between labs measuring replicates of the same sample is greater than 20% after the removal of outlying data points (e.g. Figure 1). It is difficult to make comparisons between studies and ecosystems with such a high variability between labs. We highlight the need for regular participation in interlaboratory comparison studies and continuous analytical method improvement in order to ensure accurate data. Figure 1

  12. 76 FR 48119 - Oral Rabies Vaccine Trial; Availability of a Risk Assessment and an Environmental Assessment

    Science.gov (United States)

    2011-08-08

    ...] Oral Rabies Vaccine Trial; Availability of a Risk Assessment and an Environmental Assessment AGENCY... environmental assessment relative to an oral rabies vaccination field trial in West Virginia. The environmental... rabies vaccine, analyzes the use of that vaccine in field safety and efficacy trials in West Virginia...

  13. Be-10 and Cl-36 interlaboratory comparisons

    Energy Technology Data Exchange (ETDEWEB)

    Merchel, Silke [CEREGE, Aix-en-Provence (France); FZD, Dresden (Germany); Bremser, Wolfram [BAM, Berlin (Germany); Alfimov, Vasily; Christl, Marcus; Kubik, Peter W. [PSI/ETH Zurich (Switzerland); Arnold, Maurice; Aumaitre, Georges; Benedetti, Lucilla; Bourles, Didier L.; Braucher, Regis [CEREGE, Aix-en-Provence (France); Caffee, Marc [PRIME Lab, Purdue, IN (United States); Fifield, L. Keith; Tims, Stephen G. [ANU, Canberra (Australia); Finkel, Robert C. [CEREGE, Aix-en-Provence (France); LLNL, Livermore, CA (United States); Freeman, Stewart P.H.T.; Wilcken, Klaus M.; Xu, Sheng [SUERC, East Kilbride (United Kingdom); Ruiz-Gomez, Aaron [CNA, Sevilla (Spain); Rood, Dylan H. [LLNL, Livermore, CA (United States); Sasa, Kimikazu [University of Tsukuba (Japan); Steier, Peter; Wallner, Anton [VERA, Wien (Austria)

    2009-07-01

    Driven by the progress in AMS and its spreading application within geosciences, measurements of increasing numbers of samples with low isotopic ratios will be required in the future. Therefore, we have examined the linearity of {sup 10}Be/{sup 9}Be as a function of isotope ratio by distributing 3 secondary standards (dilutions of NIST4325: 10{sup -12}-10{sup -14}) to 9 AMS labs. The problem of low ratio samples is even more crucial for {sup 36}Cl mainly due to the high volatility of chlorine. Thus, we have prepared large quantities of 3 {sup 36}Cl/Cl solutions from a certified {sup 36}Cl activity (NIST4943) by dilution with NaCl. AgCl precipitated from these solutions (10{sup -11}-10{sup -13}) has been distributed to 9 AMS labs. Some measurements are still ongoing. First results from 6 labs for each nuclide show that these interlaboratory exercises are very valuable.

  14. Interlaboratory comparison of radioimmunological parathyroid hormone determination

    International Nuclear Information System (INIS)

    Anon.

    1978-01-01

    An inter-laboratory study of serum immunoreactive PTH (iPTH) determination using standardized sera has been performed in order to check the value of the assays for the diagnosis of hyperparathyroid states. The results demonstrate: (1) that most of the cooperating laboratories (eleven of twelve) were able to discriminate between normal and grossly elevated PTH-values; (2) that direct comparison of values from different laboratories indicates very poor agreement; (3) that PTH values cannot be interpreted without a description of the characteristics of the assay used; (4) that the introduction of standard sera is advantageous and should be undertaken; (5) that determination of iPTH in serum samples is far from being a routine method when compared with radioimmunoassays for hormones like insulin, growth hormone, etc.; the difficulties being due to lack of standradized reagents and peculiarities in the metabolism of the hormone. (orig.) [de

  15. Worldwide Interlaboratory Comparison on the Determination of Trace Elements in the IAEA-457 Marine Sediment Sample

    International Nuclear Information System (INIS)

    2016-01-01

    The primary goal of the IAEA Environment Laboratories is to assist Member States in the use of both stable and radioisotope analytical techniques to understand, monitor and protect the environment. In this context, the major impact of large coastal cities on marine ecosystems is an issue of primary concern for the IAEA and the IAEA Environment Laboratories. The marine pollution assessments required to understand such impacts depend on accurate knowledge of contaminant concentrations in various environmental compartments. Through the IAEA Environment Laboratories, the IAEA has been assisting national laboratories and regional laboratory networks since the early 1970s through the provision of a reference material programme for the analysis of radionuclides, trace elements and organic compounds in marine samples. Quality assurance and quality control are two fundamental requirements to ensure the reliability of analytical results. Data that are not based on adequate quality assurance and quality control can be erroneous, and their misuse can lead to poor environmental management decisions. In this regard, the IAEA has a long history of organizing interlaboratory studies, which have evolved to include an increasing array of potential contaminants in the marine environment. Relevant activities comprise global interlaboratory comparison, regional proficiency tests, the production of marine reference materials and the development of reference methods for trace elements and organic pollutants analysis in marine samples. This publication summarizes the results of the IAEA-457 interlaboratory comparison on the determination of trace elements in a marine sediment sample

  16. Assessing the readability of ClinicalTrials.gov.

    Science.gov (United States)

    Wu, Danny T Y; Hanauer, David A; Mei, Qiaozhu; Clark, Patricia M; An, Lawrence C; Proulx, Joshua; Zeng, Qing T; Vydiswaran, V G Vinod; Collins-Thompson, Kevyn; Zheng, Kai

    2016-03-01

    ClinicalTrials.gov serves critical functions of disseminating trial information to the public and helping the trials recruit participants. This study assessed the readability of trial descriptions at ClinicalTrials.gov using multiple quantitative measures. The analysis included all 165,988 trials registered at ClinicalTrials.gov as of April 30, 2014. To obtain benchmarks, the authors also analyzed 2 other medical corpora: (1) all 955 Health Topics articles from MedlinePlus and (2) a random sample of 100,000 clinician notes retrieved from an electronic health records system intended for conveying internal communication among medical professionals. The authors characterized each of the corpora using 4 surface metrics, and then applied 5 different scoring algorithms to assess their readability. The authors hypothesized that clinician notes would be most difficult to read, followed by trial descriptions and MedlinePlus Health Topics articles. Trial descriptions have the longest average sentence length (26.1 words) across all corpora; 65% of their words used are not covered by a basic medical English dictionary. In comparison, average sentence length of MedlinePlus Health Topics articles is 61% shorter, vocabulary size is 95% smaller, and dictionary coverage is 46% higher. All 5 scoring algorithms consistently rated CliniclTrials.gov trial descriptions the most difficult corpus to read, even harder than clinician notes. On average, it requires 18 years of education to properly understand these trial descriptions according to the results generated by the readability assessment algorithms. Trial descriptions at CliniclTrials.gov are extremely difficult to read. Significant work is warranted to improve their readability in order to achieve CliniclTrials.gov's goal of facilitating information dissemination and subject recruitment. Published by Oxford University Press on behalf of the American Medical Informatics Association 2015. This work is written by US Government

  17. Assessing the population representativeness of colorectal cancer treatment clinical trials.

    Science.gov (United States)

    Zhe He; Zhiwei Chen; George, Thomas J; Lipori, Gloria; Bian

    2016-08-01

    The generalizability (external validity) of clinical trials has long been a concern for both clinical research community as well as the general public. Results of trials that do not represent the target population may not be applicable to the broader patient population. In this study, we used a previously published metric Generalizability Index for Study Traits (GIST) to assess the population representativeness of colorectal cancer (CRC) treatment trials. Our analysis showed that the quantitative eligibility criteria of CRC trials are in general not restrictive. However, the qualitative eligibility criteria in these trials are with moderate or strict restrictions, which may impact their population representativeness of the real-world patient population.

  18. Interlaboratory variability of Ki67 staining in breast cancer.

    Science.gov (United States)

    Focke, Cornelia M; Bürger, Horst; van Diest, Paul J; Finsterbusch, Kai; Gläser, Doreen; Korsching, Eberhard; Decker, Thomas

    2017-10-01

    Postanalytic issues of Ki67 assessment in breast cancers like counting method standardisation and interrater bias have been subject of various studies, but little is known about analytic variability of Ki67 staining between pathology labs. Our aim was to study interlaboratory variability of Ki67 staining in breast cancer using tissue microarrays (TMAs) and central assessment to minimise preanalytic and postanalytic influences. Thirty European pathology labs stained serial slides of a TMA set of breast cancer tissues with Ki67 according to their routine in-house protocol. The Ki67-labelling index (Ki67-LI) of 70 matched samples was centrally assessed by one observer who counted all cancer cells per sample. We then tested for differences between the labs in Ki67-LI medians by analysing variance on ranks and in proportions of tumours classified as luminal A after dichotomising oestrogen receptor-positive cancers into cancers showing low (Ki67-LI using Cochran's Q. Substantial differences between the 30 labs were indicated for median Ki67-LI (0.65%-33.0%, p cancers classified as luminal A (17%-57%, p Ki67 staining of breast cancer tissue was found between 30 routine pathology labs. Clinical use of the Ki67-LI for therapeutic decisions should be considered only fully aware of lab-specific reference values. Copyright © 2017 Elsevier Ltd. All rights reserved.

  19. NanoRelease: Pilot interlaboratory comparison of a ...

    Science.gov (United States)

    A major use of multi-walled carbon nanotubes (MWCNTs) is as functional fillers embedded in a solid matrix, such as plastics or coatings. Weathering and abrasion of the solid matrix during use can lead to environmental releases of the MWCNTs. Here we focus on a protocol to identify and quantify the primary release induced by weathering, and assess reproducibility, transferability, and sensitivity towards different materials and uses. We prepared 132 specimens of two polymer-MWCNT composites containing the same grade of MWCNTs used in earlier OECD hazard assessments but without UV stabilizer. We report on a pilot inter-laboratory comparison (ILC) with four labs (two US and two EU) aging by UV and rain, then shipping for analysis. Two labs (one US and one EU) conducted the release sampling and analysis by Transmission Electron Microscopy (TEM), Inductively Coupled Plasma- Mass Spectrometry (ICP-MS), Ultraviolet–Visible Spectroscopy (UV–Vis), Analytical Ultracentrifugation (AUC), and Asymmetric Flow Field Flow Fractionation (AF4). We compare results between aging labs, between analysis labs and between materials. Surprisingly, we found quantitative agreement between analysis labs for TEM, ICP-MS, UV–Vis; low variation between aging labs by all methods; and consistent rankings of release between TEM, ICP-MS, UV–Vis, AUC. Significant disagreement was related primarily to differences in aging, but even these cases remained within a factor of two. Published in t

  20. An Interlaboratory study of lipid effects on steroid radioimmunoassay

    International Nuclear Information System (INIS)

    Bolelli, G.F.; Franceschetti, F.; Mimmi, P.; Malvano, R.; Pilo, A.; Zucchelli; Rota, G.

    1986-01-01

    The lipid effects on the performances of routine steroid radioimmunoassay (RIA) have been assessed using the scheme of the CNR interlaboratory quality control program. Cortisol, estradiol, progesterone and testosterone assays have been considered. In the study, ca 80 laboratories were supplied with two sets of control plasma samples with different triglyceride contents (pool N, ca 120 mg/dl; pool L, ca 310 mg/dl), each corresponding to three steroid levels (level 0: charcoaldeprived samples; levels 1 and 2: the same added with increasing steroid amounts). A comparison of the neat results obtained by partecipants for both levels 1 and 2 of N and P panels - after subtraction of the concentrations estimated for level 0 - gave a direct information on lipid effects (triglycerides being assumed as an index of lipemia). In no case the abnormality high triglyceride content proved effective in practical terms, though significant differences were observed for testosterone and progesterone (ca 10% underestimation in pool L) and for estradiol (ca 10% overestimation in pool L)

  1. Canadian inter-laboratory organically bound tritium (OBT) analysis exercise.

    Science.gov (United States)

    Kim, S B; Olfert, J; Baglan, N; St-Amant, N; Carter, B; Clark, I; Bucur, C

    2015-12-01

    Tritium emissions are one of the main concerns with regard to CANDU reactors and Canadian nuclear facilities. After the Fukushima accident, the Canadian Nuclear Regulatory Commission suggested that models used in risk assessment of Canadian nuclear facilities be firmly based on measured data. Procedures for measurement of tritium as HTO (tritiated water) are well established, but there are no standard methods and certified reference materials for measurement of organically bound tritium (OBT) in environmental samples. This paper describes and discusses an inter-laboratory comparison study in which OBT in three different dried environmental samples (fish, Swiss chard and potato) was measured to evaluate OBT analysis methods currently used by CANDU Owners Group (COG) members. The variations in the measured OBT activity concentrations between all laboratories were less than approximately 20%, with a total uncertainty between 11 and 17%. Based on the results using the dried samples, the current OBT analysis methods for combustion, distillation and counting are generally acceptable. However, a complete consensus OBT analysis methodology with respect to freeze-drying, rinsing, combustion, distillation and counting is required. Also, an exercise using low-level tritium samples (less than 100 Bq/L or 20 Bq/kg-fresh) would be useful in the near future to more fully evaluate the current OBT analysis methods. Crown Copyright © 2015. Published by Elsevier Ltd. All rights reserved.

  2. Particle size distributions by transmission electron microscopy: an interlaboratory comparison case study

    Science.gov (United States)

    Rice, Stephen B; Chan, Christopher; Brown, Scott C; Eschbach, Peter; Han, Li; Ensor, David S; Stefaniak, Aleksandr B; Bonevich, John; Vladár, András E; Hight Walker, Angela R; Zheng, Jiwen; Starnes, Catherine; Stromberg, Arnold; Ye, Jia; Grulke, Eric A

    2015-01-01

    This paper reports an interlaboratory comparison that evaluated a protocol for measuring and analysing the particle size distribution of discrete, metallic, spheroidal nanoparticles using transmission electron microscopy (TEM). The study was focused on automated image capture and automated particle analysis. NIST RM8012 gold nanoparticles (30 nm nominal diameter) were measured for area-equivalent diameter distributions by eight laboratories. Statistical analysis was used to (1) assess the data quality without using size distribution reference models, (2) determine reference model parameters for different size distribution reference models and non-linear regression fitting methods and (3) assess the measurement uncertainty of a size distribution parameter by using its coefficient of variation. The interlaboratory area-equivalent diameter mean, 27.6 nm ± 2.4 nm (computed based on a normal distribution), was quite similar to the area-equivalent diameter, 27.6 nm, assigned to NIST RM8012. The lognormal reference model was the preferred choice for these particle size distributions as, for all laboratories, its parameters had lower relative standard errors (RSEs) than the other size distribution reference models tested (normal, Weibull and Rosin–Rammler–Bennett). The RSEs for the fitted standard deviations were two orders of magnitude higher than those for the fitted means, suggesting that most of the parameter estimate errors were associated with estimating the breadth of the distributions. The coefficients of variation for the interlaboratory statistics also confirmed the lognormal reference model as the preferred choice. From quasi-linear plots, the typical range for good fits between the model and cumulative number-based distributions was 1.9 fitted standard deviations less than the mean to 2.3 fitted standard deviations above the mean. Automated image capture, automated particle analysis and statistical evaluation of the data and fitting coefficients provide a

  3. Inter-laboratory project q calibration of SANS instruments using silver behenate

    International Nuclear Information System (INIS)

    Ikram, Abarrul; Gunawan; Edy Giri, Putra; Suzuki, Jun-ichi; Knott, Robert

    2000-01-01

    The inter-laboratory project for q-calibration of SANS (small angle neutron scattering) using silver behenate was carried out among Indonesia National Nuclear Energy Agency (BATAN), Japan Atomic Energy Research Institute (JAERI) and Australian Nuclear Science and Technology Organization (ANSTO). The standard sample of silver behenate, [CH 3 (CH 2 ) 20 COOAg](AgBE), has been assessed as an international standard for the calibration of both x-ray and neutron scattering instruments. The results indicate excellent agreement for q calibration obtained among the three laboratories, BATAN, JAERI and ANSTO. (Y. Kazumata)

  4. 2nd interlaboratory comparison for deuterium and oxygen-18 analysis of water samples

    International Nuclear Information System (INIS)

    Lippmann, J.; Groening, M.

    1999-01-01

    The IAEA Isotope Hydrology Laboratory organised in 1998/99 the 2nd interlaboratory comparison test for the analyses of hydrogen and oxygen isotope composition of water. The test was open to all laboratories engaged in isotope analyses of water samples world-wide. The main objective of this exercise was to help the laboratories to assess their precision and accuracy for the range of δ 18 O and δ 2 H values normally observed in meteoric waters. More than 115 laboratories from 43 countries indicated their willingness to participate in the exercise and received four water samples (OH-1 to OH-4) for analysis

  5. Interlaboratory comparison exercise for the determination of uranium by potentiometric titration (first phase)

    International Nuclear Information System (INIS)

    Verdingh, V.; Le Duigou, Y.

    1991-01-01

    Upon request of the Esarda working group on low-enriched uranium conversion and fuel fabrication plants an interlaboratory comparison was organized, to assess the precision and accuracy concerning the determination of uranium by the potentiometric titration method. This report presents the results of the first phase of this exercise (pure uranyl-nitrate solutions). The solutions used in this intercomparison have been certified for their uranium content by the CBNM, Geel. Comparison of the laboratory results with the certified values shows excellent, good and fairly good agreement for many of the participating laboratories. 10 tabs., 5 figs., 10 refs

  6. Diffusion-controlled toluene reference material for VOC emissions testing: international interlaboratory study.

    Science.gov (United States)

    Howard-Reed, Cynthia; Liu, Zhe; Cox, Steven; Leber, Dennis; Samarov, Dan; Little, John C

    2014-04-01

    The measurement of volatile organic compound (VOC) emissions from building products and materials by manufacturers and testing laboratories, and the use of the test results for labeling programs, continue to expand. One issue that hinders wide acceptance for chamber product testing is the lack of a reference material to validate test chamber performance. To meet this need, the National Institute of Standards and Technology (NIST) and Virginia Tech (VT) have developed a prototype reference material that emits a single VOC similar to the emissions of a diffusion-controlled building product source with a dynamic emissions profile. The prototype material has undergone extensive testing at NIST and a pilot interlaboratory study (ILS) with four laboratories. The next development step is an evaluation of the prototype source in multiple-sized chambers of 14 laboratories in seven countries. Each laboratory was provided duplicate specimens and a test protocol. Study results identified significant issues related to the need to store the source at a subzero Celsius temperature until tested and possible inconsistencies in large chambers. For laboratories using a small chamber and meeting all the test method criteria, the results were very encouraging with relative standard deviations ranging from 5% to 10% across the laboratories. Currently, the chamber performance of laboratories conducting product VOC emissions testing is assessed through interlaboratory studies (ILS) using a source with an unknown emission rate. As a result, laboratory proficiency can only be based on the mean and standard deviation of emission rates measured by the participating ILS laboratories. A reference material with a known emission rate has the potential to provide an independent assessment of laboratory performance as well as improve the quality of interlaboratory studies. Several international laboratories with different chamber testing systems demonstrated the ability to measure the emission rate

  7. Inter-laboratory proficiency tests to detect viral fish diseases

    DEFF Research Database (Denmark)

    Kahns, Søren; Nicolajsen, Nicole; Skall, Helle Frank

    An inter-laboratory proficiency test has ben provided by the European Community Laboratory (CRL) for Fish Diseases every year since 1996. The test is provided to all European National Reference Laboratories (NRLs) that are obliged to participate and to a limited number of non-European NRLs, making...

  8. New preparation of fish material for interlaboratory study on PFCs

    NARCIS (Netherlands)

    Korytar, P.; Lohman, M.; Kwadijk, C.J.A.F.; Barneveld, van E.

    2007-01-01

    The Institute for Environmental Studies, Vrije Universiteit (IVM) has requested Wageningen IMARES to prepare a new fish material for use in the interlaboratory performance study on analysis of perfluorinated compounds (PFCs) due to the low amount of contaminants in the previously prepared material.

  9. Inter-laboratory validation of bioaccessibility testing for metals.

    Science.gov (United States)

    Henderson, Rayetta G; Verougstraete, Violaine; Anderson, Kim; Arbildua, José J; Brock, Thomas O; Brouwers, Tony; Cappellini, Danielle; Delbeke, Katrien; Herting, Gunilla; Hixon, Greg; Odnevall Wallinder, Inger; Rodriguez, Patricio H; Van Assche, Frank; Wilrich, Peter; Oller, Adriana R

    2014-10-01

    Bioelution assays are fast, simple alternatives to in vivo testing. In this study, the intra- and inter-laboratory variability in bioaccessibility data generated by bioelution tests were evaluated in synthetic fluids relevant to oral, inhalation, and dermal exposure. Using one defined protocol, five laboratories measured metal release from cobalt oxide, cobalt powder, copper concentrate, Inconel alloy, leaded brass alloy, and nickel sulfate hexahydrate. Standard deviations of repeatability (sr) and reproducibility (sR) were used to evaluate the intra- and inter-laboratory variability, respectively. Examination of the sR:sr ratios demonstrated that, while gastric and lysosomal fluids had reasonably good reproducibility, other fluids did not show as good concordance between laboratories. Relative standard deviation (RSD) analysis showed more favorable reproducibility outcomes for some data sets; overall results varied more between- than within-laboratories. RSD analysis of sr showed good within-laboratory variability for all conditions except some metals in interstitial fluid. In general, these findings indicate that absolute bioaccessibility results in some biological fluids may vary between different laboratories. However, for most applications, measures of relative bioaccessibility are needed, diminishing the requirement for high inter-laboratory reproducibility in absolute metal releases. The inter-laboratory exercise suggests that the degrees of freedom within the protocol need to be addressed. Copyright © 2014 Elsevier Inc. All rights reserved.

  10. Reporting methods of blinding in randomized trials assessing nonpharmacological treatments.

    Directory of Open Access Journals (Sweden)

    Isabelle Boutron

    2007-02-01

    Full Text Available BACKGROUND: Blinding is a cornerstone of treatment evaluation. Blinding is more difficult to obtain in trials assessing nonpharmacological treatment and frequently relies on "creative" (nonstandard methods. The purpose of this study was to systematically describe the strategies used to obtain blinding in a sample of randomized controlled trials of nonpharmacological treatment. METHODS AND FINDINGS: We systematically searched in Medline and the Cochrane Methodology Register for randomized controlled trials (RCTs assessing nonpharmacological treatment with blinding, published during 2004 in high-impact-factor journals. Data were extracted using a standardized extraction form. We identified 145 articles, with the method of blinding described in 123 of the reports. Methods of blinding of participants and/or health care providers and/or other caregivers concerned mainly use of sham procedures such as simulation of surgical procedures, similar attention-control interventions, or a placebo with a different mode of administration for rehabilitation or psychotherapy. Trials assessing devices reported various placebo interventions such as use of sham prosthesis, identical apparatus (e.g., identical but inactivated machine or use of activated machine with a barrier to block the treatment, or simulation of using a device. Blinding participants to the study hypothesis was also an important method of blinding. The methods reported for blinding outcome assessors relied mainly on centralized assessment of paraclinical examinations, clinical examinations (i.e., use of video, audiotape, photography, or adjudications of clinical events. CONCLUSIONS: This study classifies blinding methods and provides a detailed description of methods that could overcome some barriers of blinding in clinical trials assessing nonpharmacological treatment, and provides information for readers assessing the quality of results of such trials.

  11. Quality assessment of randomized clinical trial in intensive care.

    Science.gov (United States)

    Gonçalves, Giulliano Peixoto; Barbosa, Fabiano Timbó; Barbosa, Luciano Timbó; Duarte, José Lira

    2009-03-01

    A randomized clinical trial is a prospective study that compares the effect and value of interventions in human beings, of one or more groups vs. a control group. The objective of this study was to evaluate the quality of published randomized clinical trials in Intensive care in Brazil. All randomized clinical trials in intensive care found by manual search in Revista Brasileira de Terapia Intensiva from January 2001 to March 2008 were assessed to evaluate their description by the quality scale. Descriptive statistics and a 95 % confidence interval were used for the primary outcome. Our primary outcome was the randomized clinical trial quality. Our search found 185 original articles, of which 14 were randomized clinical trials. Only one original article (7.1%) showed good quality. There was no statistical significance between the collected data and the data shown in the hypothesis of this search. It can be concluded that in the sample of assessed articles 7% of the randomized clinical trials in intensive care published in a single intensive care journal in Brazil, present good methodological quality.

  12. First Interlaboratory Comparison on Calibration of Temperature-Controlled Enclosures in Turkey

    Science.gov (United States)

    Uytun, A.; Kalemci, M.

    2017-11-01

    The number of accredited laboratories in the field of calibration of temperature-controlled enclosures has been increasing in Turkey. One of the main criteria demonstrating the competence of a calibration laboratory is successful participation in interlaboratory comparisons. Therefore, TUBITAK UME Temperature Laboratory organized the first interlaboratory comparison on "Calibration of Temperature-Controlled Enclosures" in Turkey as a pilot laboratory between January and November, 2013. Forty accredited laboratories which provide routine calibration services to the industry in this field participated in the comparison. The standards used during the comparison was a climatic chamber for the measurements at -40 {°}C, -20 {°}C, 40 {°}C and 100 {°}C and an oven for the measurements at 200 {°}C. The protocol of the comparison was prepared considering guide EURAMET cg-20 and BS EN/IEC standards 600068-3-5 and 600068-3-11. During the comparison measurements, each participant had the liberty to choose the most convenient calibration points in terms of their accreditation scope among the values mentioned above and carried out on-site measurements at UME. The details and the results of this comparison are given in the paper. Determination of the statistical consistency of the results with the uncertainties given by the participants can be assessed by the method of En value assessment for each laboratory. En values for all measurement results based on the results of pilot and participating laboratories were calculated.

  13. Assessing bias in osteoarthritis trials included in Cochrane reviews

    DEFF Research Database (Denmark)

    Hansen, Julie Bolvig; Juhl, Carsten Bogh; Boutron, Isabelle

    2014-01-01

    the first appearing forest plot for overall pain in the Cochrane review. Treatment effect sizes will be expressed as standardised mean differences (SMDs), where the difference in mean values available from the forest plots is divided by the pooled SD. To empirically assess the risk of bias in treatment......INTRODUCTION: The validity of systematic reviews and meta-analysis depends on methodological quality and unbiased dissemination of trials. Our objective is to evaluate the association of estimates of treatment effects with different bias-related study characteristics in meta...... benefits, we will perform stratified analyses of the trials from the included meta-analyses and assess the interaction between trial characteristics and treatment effect. A relevant study-level covariate is defined as one that decreases the between-study variance (τ(2), estimated as Tau...

  14. Results of four inter-laboratory comparisons provided by the Forensic Isotope Ratio Mass Spectrometry (FIRMS) network.

    Science.gov (United States)

    Carter, James F; Hill, Jenny C; Doyle, Sean; Lock, Claire

    2009-06-01

    Between 2004 and 2008 the Forensic Isotope Ratio Mass Spectrometry (FIRMS) network organised four Inter-Laboratory Camparison excercises with the aim of harmonising and validating isotopic measurements to be used for forensic applications. The samples distributed comprised materials of potential forensic interest such as packaging and pharmaceuticals to be analysed for delta2H, delta13C, delta15N and delta18O composition. As many as 30 international laboratories participated in these comparisons. Results have shown overall improvements for both within- and inter-laboratory reproducibility with respect to delta13C and delta15N measurements. Only a small number of laboratories returned results for delta2H and delta18O analysis and these results highlighted a need for improvement in the reproducibility of these measurements and a need to address the exchange of hydrogen between samples and ambient moisture. Results also highlighted the importance of sample preparation procedures and the need to standardise both these procedures and calibration against Standard Reference Materials. Future Inter-laboratory Comparison exercises will assess the suitability of laboratories to submit data to national and international databases similar to those currently operated for fingerprints, DNA etc.

  15. [Interlaboratory test: Isolation of Mycobacterium bovis from granulomatous lesions in bovine].

    Science.gov (United States)

    Garbaccio, Sergio; Barandiaran, Soledad; Fernandez, Analía; Macias, Analía; Magnano, Gabriel; Martinez Vivot, Marcela; Peyrú, Maite; Cataldi, Angel

    2016-01-01

    Mycobacterium bovis is the causative agent of bovine tuberculosis. The diagnostic laboratory confirmation is made through bacterial isolation. The aim of interlaboratory tests is to assess the performance of each participant in comparison with other of similar capacities. The test objective was to determine the efficiency of isolation of M. bovis. Four laboratories were part of the test and processed 25 blind tissue samples from granulomatous lesions and with previous M. bovis isolation. The laboratory that had the highest proportion of isolates was A (68%), followed by C (60%) and then B and D (both with 52%). The greatest concordance was observed between B-D and B-C laboratories (68%). The differences could be due to specific factors in each laboratory procedures. This type of interlaboratory tests highlights errors in the bacteriology and identifies critical points in the process to detect M. bovis accurately. Copyright © 2016 Asociación Argentina de Microbiología. Publicado por Elsevier España, S.L.U. All rights reserved.

  16. Results of the Interlaboratory Exercise CSN/CIEMAT-100 Among Environmental Radioactivity Laboratories (Soil)

    International Nuclear Information System (INIS)

    Romero Gonzalez, M. L.

    2002-01-01

    The document describes the outcome of the CSN/CIEMAT-00 interlaboratory test comparison among environmental radioactivity laboratories. the exercise was organised according to the ISO-43 and the ISO/IUPAC/AOAC Harmonized Protocol for the proficiency testing of analytical laboratories. the test sample was a soil containing environmental levels of K-40, Ra-226, Ac-228, Sr-90, Cs-137, Cs-134, Pu (239-240) y Am-241. the Universidad Autonoma de Barcelona prepared the material and reported adequate statistical studies of homogeneity. The results of the exercise were computed for 30 participating laboratories, and their analytical performance was assessed using the u-score approach. A raised percentage of satisfactory laboratory performance has been obtained for all the analysis, being the best performance in gamma measurements. The exercise has drawn that several laboratories have difficulties in the evaluation of combined uncertainty, mainly in analysis involving radiochemical steps. The study has shown an homogeneous inter-laboratory behaviour, and the improvement achieved through subsequent exercises in the quality of the data they are producing. (Author) 10 refs

  17. Inter-laboratory analysis of selected genetically modified plant reference materials with digital PCR.

    Science.gov (United States)

    Dobnik, David; Demšar, Tina; Huber, Ingrid; Gerdes, Lars; Broeders, Sylvia; Roosens, Nancy; Debode, Frederic; Berben, Gilbert; Žel, Jana

    2018-01-01

    Digital PCR (dPCR), as a new technology in the field of genetically modified (GM) organism (GMO) testing, enables determination of absolute target copy numbers. The purpose of our study was to test the transferability of methods designed for quantitative PCR (qPCR) to dPCR and to carry out an inter-laboratory comparison of the performance of two different dPCR platforms when determining the absolute GM copy numbers and GM copy number ratio in reference materials certified for GM content in mass fraction. Overall results in terms of measured GM% were within acceptable variation limits for both tested dPCR systems. However, the determined absolute copy numbers for individual genes or events showed higher variability between laboratories in one third of the cases, most possibly due to variability in the technical work, droplet size variability, and analysis of the raw data. GMO quantification with dPCR and qPCR was comparable. As methods originally designed for qPCR performed well in dPCR systems, already validated qPCR assays can most generally be used for dPCR technology with the purpose of GMO detection. Graphical abstract The output of three different PCR-based platforms was assessed in an inter-laboratory comparison.

  18. Responsible Translation of Stem Cell Research: An Assessment of Clinical Trial Registration and Publications

    OpenAIRE

    Fung, Moses; Yuan, Yan; Atkins, Harold; Shi, Qian; Bubela, Tania

    2017-01-01

    Summary We assessed the extent to which the publication of clinical trial results of innovative cell-based interventions reflects International Society for Stem Cell Research best practice guidelines. We assessed: (1) characteristics and time to publication of completed trials; (2) quality of reported trials; and (3) results of published trials. We identified and analyzed publications from 1,052 novel stem cell clinical trials: 179 (45.4%) of 393 completed trials had published results; 48 tri...

  19. High Interlaboratory Reprocucibility of DNA Sequence-based Typing of Bacteria in a Multicenter Study

    DEFF Research Database (Denmark)

    Sousa, MA de; Boye, Kit; Lencastre, H de

    2006-01-01

    Current DNA amplification-based typing methods for bacterial pathogens often lack interlaboratory reproducibility. In this international study, DNA sequence-based typing of the Staphylococcus aureus protein A gene (spa, 110 to 422 bp) showed 100% intra- and interlaboratory reproducibility without...... extensive harmonization of protocols for 30 blind-coded S. aureus DNA samples sent to 10 laboratories. Specialized software for automated sequence analysis ensured a common typing nomenclature.......Current DNA amplification-based typing methods for bacterial pathogens often lack interlaboratory reproducibility. In this international study, DNA sequence-based typing of the Staphylococcus aureus protein A gene (spa, 110 to 422 bp) showed 100% intra- and interlaboratory reproducibility without...

  20. Traditional and new composite endpoints in heart failure clinical trials : facilitating comprehensive efficacy assessments and improving trial efficiency

    NARCIS (Netherlands)

    Anker, Stefan D. t; Schroeder, Stefan; Atar, Dan; Bax, Jeroen J.; Ceconi, Claudio; Cowie, Martin R.; AdamCrisp,; Dominjon, Fabienne; Ford, Ian; Ghofrani, Hossein-Ardeschir; Gropper, Savion; Hindricks, Gerhard; Hlatky, Mark A.; Holcomb, Richard; Honarpour, Narimon; Jukema, J. Wouter; Kim, Albert M.; Kunz, Michael; Lefkowitz, Martin; Le Floch, Chantal; Landmesser, Ulf; McDonagh, Theresa A.; McMurray, John J.; Merkely, Bela; Packer, Milton; Prasad, Krishna; Revkin, James; Rosano, Giuseppe M. C.; Somaratne, Ransi; Stough, Wendy Gattis; Voors, Adriaan A.; Ruschitzka, Frank

    Composite endpoints are commonly used as the primary measure of efficacy in heart failure clinical trials to assess the overall treatment effect and to increase the efficiency of trials. Clinical trials still must enrol large numbers of patients to accrue a sufficient number of outcome events and

  1. Inter-laboratory exercise on steroid estrogens in aqueous samples

    Energy Technology Data Exchange (ETDEWEB)

    Heath, E., E-mail: ester.heath@ijs.s [Department of Environmental Sciences, Jozef Stefan Institute, Jamova 39, 1000 Ljubljana (Slovenia); Kosjek, T. [Department of Environmental Sciences, Jozef Stefan Institute, Jamova 39, 1000 Ljubljana (Slovenia); Andersen, H.R.; Holten Luetzhoft, H.-C. [Department of Environmental Engineering, Technical University of Denmark, Miljoevej 113, DK-2800 Kgs. Lyngby (Denmark); Adolfson Erici, M. [Stockholm University, ITM SE-106 91 Stockholm (Sweden); Coquery, M. [Cemagref, U.R. QELY, F-69336 Lyon (France); Duering, R.-A. [Giessen University, Institute of Soil Science and Soil Conservation, Giessen (Germany); Gans, O. [Umweltbundesamt GmbH, Unit Organic Analysis, Spittelauer Laende 5, 1090 Vienna (Austria); Guignard, C. [CRP Gabriel Lippmann, EVA, 41 rue du Brill, L-4422 Belvaux (Luxembourg); Karlsson, P. [Lantmannen Analycen AB, Research and Development, Sjoehagsgatan 3 Box 905, 5319, Lidkoeping (Sweden); Manciot, F. [CAE VEOLIA ENVIRONMENT, 1 Place de Turenne, 94417 Saint Maurice Cedex (France); Moldovan, Z. [National Institute of Research and Development for Isotopic and Molecular Technology, Mass Spectrometry Department, Str. Donath 65-103, 400293 Cluj-Napoca (Romania); Patureau, D. [INRA, UR50, Laboratoire de Biotechnologie de l' Environnemet (LBE), Avenue des etangs, F-11100 Narbonne (France); Cruceru, L. [Pollution Control Department, National Research Institute for Industrial Ecology (ECOIND), Sos.Panduri 90-92, sector 5, Bucharest (Romania); Sacher, F. [DVGW-Technologiezentrum Wasser, Karlsruher Strasse 84, 76139 Karlsruhe (Germany); Ledin, A. [Department of Environmental Engineering, Technical University of Denmark, Miljoevej 113, DK-2800 Kgs. Lyngby (Denmark)

    2010-03-15

    An inter-laboratory comparison exercise was organized among European laboratories, under the aegis of EU COST Action 636: 'Xenobiotics in Urban Water Cycle'. The objective was to evaluate the performance of testing laboratories determining 'Endocrine Disrupting Compounds' (EDC) in various aqueous matrices. As the main task three steroid estrogens: 17alpha-ethinylestradiol, 17beta-estradiol and estrone were determined in four spiked aqueous matrices: tap water, river water and wastewater treatment plant influent and effluent using GC-MS and LC-MS/MS. Results were compared and discussed according to the analytical techniques applied, the accuracy and reproducibility of the analytical methods and the nature of the sample matrices. Overall, the results obtained in this inter-laboratory exercise reveal a high level of competence among the participating laboratories for the detection of steroid estrogens in water samples indicating that GC-MS as well as LC-MS/MS can equally be employed for the analysis of natural and synthetic hormones. - Herein are presented the results of the first international inter-laboratory study on determination of selected steroid hormones in environmental aqueous samples.

  2. The precision and robustness of published protocols for disc diffusion assays of antimicrobial agent susceptibility: an inter-laboratory study

    DEFF Research Database (Denmark)

    Gabhainn, S.N.; Bergh, Ø.; Dixon, B.

    2004-01-01

    measurements were generated. The total data generated in the trial was used to quantify the intra- and inter-laboratory precisions. The study design also facilitated the investigation of the influence of the source of media and the source of discs on zone sizes. A smaller two-laboratory trial was employed......The precision of the disc diffusion protocols previously published by Alderman and Smith (Aquaculture 196 (2002) 211) was analysed in a seven-laboratory trial using Escherichia coli ATCC 25922 as the test strain. Discs containing seven antimicrobial agents were employed and 2899 zone size...... for each agent being 11.1%. Significant influences on zone size were detected for all three parameters of the protocol. Media source effects were particularly notable with respect to oxytetracycline and oxolinic acid discs, disc source effects with respect to ampicillin and sulphamethoxazole...

  3. Practical methodological guide for hydrometric inter-laboratory organisation

    Science.gov (United States)

    Besson, David; Bertrand, Xavier

    2015-04-01

    Discharge measurements performed by the French governmental hydrometer team feed a national database. This data is available for general river flows knowkedge, flood forecasting, low water survey, statistical calculations flow, control flow regulatory and many other uses. Regularly checking the measurements quality and better quantifying its accuracy is therefore an absolute need. The practice of inter-laboratory comparison in hydrometry particularly developed during the last decade. Indeed, discharge measurement can not easily be linked to a standard. Therefore, on-site measurement accuracy control is very difficult. Inter-laboratory comparison is thus a practical solution to this issue. However, it needs some regulations in order to ease its practice and legitimize its results. To do so, the French government hydrometrics teams produced a practical methodological guide for hydrometric inter-laboratory organisation in destination of hydrometers community in view of ensure the harmonization of inter-laboratory comparison practices for different materials (ADCP, current meter on wadind rod or gauging van, tracer dilution, surface speed) and flow range (flood, low water). Ensure the results formalization and banking. The realisation of this practice guide is grounded on the experience of the governmental teams & their partners (or fellows), following existing approaches (Doppler group especially). The guide is designated to validate compliance measures and identify outliers : Hardware, methodological, environmental, or human. Inter-laboratory comparison provides the means to verify the compliance of the instruments (devices + methods + operators) and provides methods to determine an experimental uncertainty of the tested measurement method which is valid only for the site and the measurement conditions but does not address the calibration or periodic monitoring of the few materials. After some conceptual definitions, the guide describes the different stages of an

  4. Interlaboratory comparisons in kerma in the air measures and absorbed dose in water using 60Co beams in radiotherapy

    International Nuclear Information System (INIS)

    Rosado, Paulo Henrique Goncalves; Silva, Cosme Norival Mello da

    2013-01-01

    In order to ensure that the measures of a quantity have high reliability and traceability interlaboratory comparisons are performed. The LNMRI has participated in several these interlaboratory comparisons. In the period 2000-2013 the LNMRI participated in 5 interlaboratory comparisons for measurement of kerma coefficients in the air and absorbed dose coefficients in the water. The results of interlaboratory comparisons indicate that the measures taken are appropriate to the LNMRI regarding the accuracy and precision measuring of these quantities

  5. Modification of the method for determining protein solubility of heat treated full-fat soybeans using extraction in potassium hydroxide: Inter-laboratory study

    Directory of Open Access Journals (Sweden)

    Palić Dragan V.

    2012-01-01

    Full Text Available Among a number of laboratory methods used to estimate the adequacy of heat treatment applied to full-fat soybean (FFSB protein solubility in potassium hydroxide (PSKOH is an unofficial method, but it is used by many laboratories due to its simplicity. It has been reported that the results of PSKOH analysis of the same sample of FFSB on the degree of heat treatment vary widely between laboratories. In this study, the original PSKOH method has been modified and subjected to an inter-laboratory test, with participation of 9 laboratories. Eight FFBS samples were processed by dry extrusion at temperatures ranging from 110 to 164°C and analysed on PSKOH. Processed FFSB samples were also assessed in a growth trial with broilers. Analysis of FFSB by the PSKOH method generated for adequately-processed FFSB values between 67.1 and 76.5%. The values above 76.5% corresponded to under-processed and below 67.1% to over-processed FFSB. The PSKOH method generated good precision, i.e. the repeatability and reproducibility limits of 3.48 and 10.86 %, respectively. The modified PSKOH method can be recommended as a reliable indicator for quality control of heat processed FFSB for the use in routine laboratory practice. This study could pave the way for establishing PSKOH as an official method for determining the nutritional value of FFSB following heat treatment.

  6. Inter-laboratory variation in DNA damage using a standard comet assay protocol

    DEFF Research Database (Denmark)

    Forchhammer, Lykke; Ersson, Clara; Loft, Steffen

    2012-01-01

    There are substantial inter-laboratory variations in the levels of DNA damage measured by the comet assay. The aim of this study was to investigate whether adherence to a standard comet assay protocol would reduce inter-laboratory variation in reported values of DNA damage. Fourteen laboratories ...

  7. A quality assessment of randomized controlled trial reports in endodontics.

    Science.gov (United States)

    Lucena, C; Souza, E M; Voinea, G C; Pulgar, R; Valderrama, M J; De-Deus, G

    2017-03-01

    To assess the quality of the randomized clinical trial (RCT) reports published in Endodontics between 1997 and 2012. Retrieval of RCTs in Endodontics was based on a search of the Thomson Reuters Web of Science (WoS) database (March 2013). Quality evaluation was performed using a checklist based on the Jadad criteria, CONSORT (Consolidated Standards of Reporting Trials) statement and SPIRIT (Standard Protocol Items: Recommendations for Interventional Trials). Descriptive statistics were used for frequency distribution of data. Student's t-test and Welch test were used to identify the influence of certain trial characteristics upon report quality (α = 0.05). A total of 89 RCTs were evaluated, and several methodological flaws were found: only 45% had random sequence generation at low risk of bias, 75% did not provide information on allocation concealment, and 19% were nonblinded designs. Regarding statistics, only 55% of the RCTs performed adequate sample size estimations, only 16% presented confidence intervals, and 25% did not provide the exact P-value. Also, 2% of the articles used no statistical tests, and in 87% of the RCTs, the information provided was insufficient to determine whether the statistical methodology applied was appropriate or not. Significantly higher scores were observed for multicentre trials (P = 0.023), RCTs signed by more than 5 authors (P = 0.03), articles belonging to journals ranked above the JCR median (P = 0.03), and articles complying with the CONSORT guidelines (P = 0.000). The quality of RCT reports in key areas for internal validity of the study was poor. Several measures, such as compliance with the CONSORT guidelines, are important in order to raise the quality of RCTs in Endodontics. © 2016 International Endodontic Journal. Published by John Wiley & Sons Ltd.

  8. Consensus building for interlaboratory studies, key comparisons, and meta-analysis

    Science.gov (United States)

    Koepke, Amanda; Lafarge, Thomas; Possolo, Antonio; Toman, Blaza

    2017-06-01

    Interlaboratory studies in measurement science, including key comparisons, and meta-analyses in several fields, including medicine, serve to intercompare measurement results obtained independently, and typically produce a consensus value for the common measurand that blends the values measured by the participants. Since interlaboratory studies and meta-analyses reveal and quantify differences between measured values, regardless of the underlying causes for such differences, they also provide so-called ‘top-down’ evaluations of measurement uncertainty. Measured values are often substantially over-dispersed by comparison with their individual, stated uncertainties, thus suggesting the existence of yet unrecognized sources of uncertainty (dark uncertainty). We contrast two different approaches to take dark uncertainty into account both in the computation of consensus values and in the evaluation of the associated uncertainty, which have traditionally been preferred by different scientific communities. One inflates the stated uncertainties by a multiplicative factor. The other adds laboratory-specific ‘effects’ to the value of the measurand. After distinguishing what we call recipe-based and model-based approaches to data reductions in interlaboratory studies, we state six guiding principles that should inform such reductions. These principles favor model-based approaches that expose and facilitate the critical assessment of validating assumptions, and give preeminence to substantive criteria to determine which measurement results to include, and which to exclude, as opposed to purely statistical considerations, and also how to weigh them. Following an overview of maximum likelihood methods, three general purpose procedures for data reduction are described in detail, including explanations of how the consensus value and degrees of equivalence are computed, and the associated uncertainty evaluated: the DerSimonian-Laird procedure; a hierarchical Bayesian

  9. Quantifying inter-laboratory variability in stable isotope analysis of ancient skeletal remains.

    Science.gov (United States)

    Pestle, William J; Crowley, Brooke E; Weirauch, Matthew T

    2014-01-01

    Over the past forty years, stable isotope analysis of bone (and tooth) collagen and hydroxyapatite has become a mainstay of archaeological and paleoanthropological reconstructions of paleodiet and paleoenvironment. Despite this method's frequent use across anthropological subdisciplines (and beyond), the present work represents the first attempt at gauging the effects of inter-laboratory variability engendered by differences in a) sample preparation, and b) analysis (instrumentation, working standards, and data calibration). Replicate analyses of a 14C-dated ancient human bone by twenty-one archaeological and paleoecological stable isotope laboratories revealed significant inter-laboratory isotopic variation for both collagen and carbonate. For bone collagen, we found a sizeable range of 1.8‰ for δ13Ccol and 1.9‰ for δ15Ncol among laboratories, but an interpretatively insignificant average pairwise difference of 0.2‰ and 0.4‰ for δ13Ccol and δ15Ncol respectively. For bone hydroxyapatite the observed range increased to a troublingly large 3.5‰ for δ13Cap and 6.7‰ for δ18Oap, with average pairwise differences of 0.6‰ for δ13Cap and a disquieting 2.0‰ for δ18Oap. In order to assess the effects of preparation versus analysis on isotopic variability among laboratories, a subset of the samples prepared by the participating laboratories were analyzed a second time on the same instrument. Based on this duplicate analysis, it was determined that roughly half of the isotopic variability among laboratories could be attributed to differences in sample preparation, with the other half resulting from differences in analysis (instrumentation, working standards, and data calibration). These findings have serious implications for choices made in the preparation and extraction of target biomolecules, the comparison of results obtained from different laboratories, and the interpretation of small differences in bone collagen and hydroxyapatite isotope values

  10. Quantifying inter-laboratory variability in stable isotope analysis of ancient skeletal remains.

    Directory of Open Access Journals (Sweden)

    William J Pestle

    Full Text Available Over the past forty years, stable isotope analysis of bone (and tooth collagen and hydroxyapatite has become a mainstay of archaeological and paleoanthropological reconstructions of paleodiet and paleoenvironment. Despite this method's frequent use across anthropological subdisciplines (and beyond, the present work represents the first attempt at gauging the effects of inter-laboratory variability engendered by differences in a sample preparation, and b analysis (instrumentation, working standards, and data calibration. Replicate analyses of a 14C-dated ancient human bone by twenty-one archaeological and paleoecological stable isotope laboratories revealed significant inter-laboratory isotopic variation for both collagen and carbonate. For bone collagen, we found a sizeable range of 1.8‰ for δ13Ccol and 1.9‰ for δ15Ncol among laboratories, but an interpretatively insignificant average pairwise difference of 0.2‰ and 0.4‰ for δ13Ccol and δ15Ncol respectively. For bone hydroxyapatite the observed range increased to a troublingly large 3.5‰ for δ13Cap and 6.7‰ for δ18Oap, with average pairwise differences of 0.6‰ for δ13Cap and a disquieting 2.0‰ for δ18Oap. In order to assess the effects of preparation versus analysis on isotopic variability among laboratories, a subset of the samples prepared by the participating laboratories were analyzed a second time on the same instrument. Based on this duplicate analysis, it was determined that roughly half of the isotopic variability among laboratories could be attributed to differences in sample preparation, with the other half resulting from differences in analysis (instrumentation, working standards, and data calibration. These findings have serious implications for choices made in the preparation and extraction of target biomolecules, the comparison of results obtained from different laboratories, and the interpretation of small differences in bone collagen and hydroxyapatite

  11. Characterisation of humic material for inter-laboratory comparison

    International Nuclear Information System (INIS)

    Peachy, D.; Bradley, A.D.; Davis, A.E.; Stuart, M.E.; Tait, B.A.R.; Vickers, B.P.; Williams, G.M.

    1988-01-01

    The characterisation and interlaboratory comparison of common humic materials by members of the European Commission's COCO group (set up to study complexes and colloids), forms part of a study of the effects of natural organic compounds in groundwater on the complexation and mobility of radionuclides. Three samples have been characterised: a sodium salt and a protonated form of the commercially available humic acid from Aldrich Chemicals; and a protonated humic acid from the Gorleben research site in Germany. Characterisation undertaken by BGS includes moisture content, elemental analysis, metal content, functional group analysis, infra-red spectroscopy, ultra-violet absorbance (E 4 /E 6 ratios), and ultra-filtration. (author)

  12. Inter-laboratory exercise on steroid estrogens in aqueous samples

    DEFF Research Database (Denmark)

    Heath, E.; Kosjek, T.; Andersen, Henrik Rasmus

    2010-01-01

    matrices. As the main task three steroid estrogens. 17 alpha-ethinylestradiol, 17 beta-estradiol and estrone were determined in four spiked aqueous matrices' tap water, river water and wastewater treatment plant influent and effluent using GC-MS and LC-MS/MS Results were compared and discussed according...... to the analytical techniques applied, the accuracy and reproducibility of the analytical methods and the nature of the sample matrices. Overall, the results obtained in this inter-laboratory exercise reveal a high level of competence among the participating laboratories for the detection of steroid estrogens...

  13. Interlaboratory studies and initiatives developing standards for proteomics

    Science.gov (United States)

    Ivanov, Alexander R.; Colangelo, Christopher M.; Dufresne, Craig P.; Friedman, David B.; Lilley, Kathryn S.; Mechtler, Karl; Phinney, Brett S.; Rose, Kristie L.; Rudnick, Paul A.; Searle, Brian C.; Shaffer, Scott A.; Weintraub, Susan T.

    2013-01-01

    Proteomics is a rapidly transforming interdisciplinary field of research that embraces a diverse set of analytical approaches to tackle problems in fundamental and applied biology. This view-point article highlights the benefits of interlaboratory studies and standardization initiatives to enable investigators to address many of the challenges found in proteomics research. Among these initiatives, we discuss our efforts on a comprehensive performance standard for characterizing PTMs by MS that was recently developed by the Association of Biomolecular Resource Facilities (ABRF) Proteomics Standards Research Group (sPRG). PMID:23319436

  14. Methodological issues in randomized trials assessing probiotics for periodontal treatment.

    Science.gov (United States)

    Dhingra, K

    2012-02-01

    Probiotics traditionally used in medicine field are now being used in an attempt to control and treat periodontal disease. However, the trials used to analyze the effects of probiotics have been subject to methodological criticism. The aim of this review was to assess the methodological deficiencies in randomized controlled trials evaluating the efficacy and safety of oral administration of probiotics for the treatment of periodontal disease. A manual and electronic literature search (of MEDLINE and The Cochrane Library) was made, to March 2011, for randomized controlled trials presenting clinical, microbiological, immunological and patient-centered data for the efficacy of probiotics compared with a placebo/standard periodontal therapy for the treatment of periodontal disease. The literature search yielded only four randomized double-blind, placebo-controlled studies that evaluated the efficacy of probiotics (using Lactobacillus reuteri and Lactobacillus salivarius probiotic strains) in patients with gingivitis. The studies were too methodologically flawed (of mediocre quality) with a high risk of bias for any meaningful conclusions to be reached. These studies lacked adequate descriptions of appropriate randomization, allocation concealment, blinding, formulation and dosage of probiotic and placebo, extent and severity of periodontal disease in patient populations, patient-centered outcomes, results data and potential confounding factors. The existing randomized controlled trials have important methodological limitations; consequently, there is insufficient evidence to support the efficacy of probiotics in treating periodontal disease. More rigorous scientific research, in accordance with existing guidelines and research recommendations of the present review, is required to examine the safety and efficacy of probiotics before they are embraced in periodontal therapy. © 2011 John Wiley & Sons A/S.

  15. Clinical outcomes assessment in clinical trials to assess treatment of femoroacetabular impingement

    DEFF Research Database (Denmark)

    Harris-Hayes, Marcie; McDonough, Christine M; Leunig, Michael

    2013-01-01

    Patient-reported outcome measures are an important component of outcomes assessment in clinical trials to assess the treatment of femoroacetabular impingement (FAI). This review of disease-specific measures and instruments used to assess the generic quality of life and physical activity levels...... developed recently and have not been established in the literature. Although currently used generic and activity-level measures have limitations, as well, they should be considered, depending on the specific goals of the study. Additional research is needed to assess the properties of these measures fully...

  16. 129I Interlaboratory comparison: phase I and phase II

    International Nuclear Information System (INIS)

    Caffee, M. W.; Roberts, M. L.

    1999-01-01

    An interlaboratory comparison exercise for 129 I was organized and conducted. Nine laboratories participated in the exercise to either a full or limited extent. In Phase I of the comparison, 11 samples were measured. The suite of samples contained both synthetic ''standard type'' materials (i.e., AgI) and environmental materials. The isotopic 129 I/ 127 I ratios of the samples varied from 10 -8 to 10 -14 . In this phase, each laboratory was responsible for its own chemical preparation of the samples. In Phase I, the 129 I AMS measurements for prepared AgI were in good agreement. However, large discrepancies were seen in 129 I AMS measurements of environmental samples. Because of the large discrepancies seen in the Phase I 129 I intercomparison, a subsequent study was conducted. In Phase II of the 129 I intercomparison, three separate laboratories prepared AgI from two environmental samples (IAEA 375 soil and maples leaves). Each laboratory used its own chemical preparation method with each of the methods being distinctly different. The resulting six samples (two sets of three) were then re-distributed to the participating 129 I AMS facilities and 129 I/ 127 I ratios measured. Results and discussion of both the Phase I and Phase II interlaboratory comparison are presented

  17. Qualitative PCR method for Roundup Ready soybean: interlaboratory study.

    Science.gov (United States)

    Kodama, Takashi; Kasahara, Masaki; Minegishi, Yasutaka; Futo, Satoshi; Sawada, Chihiro; Watai, Masatoshi; Akiyama, Hiroshi; Teshima, Reiko; Kurosawa, Yasunori; Furui, Satoshi; Hino, Akihiro; Kitta, Kazumi

    2011-01-01

    Quantitative and qualitative methods based on PCR have been developed for genetically modified organisms (GMO). Interlaboratory studies were previously conducted for GMO quantitative methods; in this study, an interlaboratory study was conducted for a qualitative method for a GM soybean, Roundup Ready soy (RR soy), with primer pairs designed for the quantitative method of RR soy studied previously. Fourteen laboratories in Japan participated. Each participant extracted DNA from 1.0 g each of the soy samples containing 0, 0.05, and 0.10% of RR soy, and performed PCR with primer pairs for an internal control gene (Le1) and RR soy followed by agarose gel electrophoresis. The PCR product amplified in this PCR system for Le1 was detected from all samples. The sensitivity, specificity, and false-negative and false-positive rates of the method were obtained from the results of RR soy detection. False-negative rates at the level of 0.05 and 0.10% of the RR soy samples were 6.0 and 2.3%, respectively, revealing that the LOD of the method was somewhat below 0.10%. The current study demonstrated that the qualitative method would be practical for monitoring the labeling system of GM soy in kernel lots.

  18. The effect of inter-laboratory variability on the protein:creatinine (UPC) ratio in canine urine.

    Science.gov (United States)

    Rossi, G; Bertazzolo, W; Dondi, F; Binnella, M; Gruarin, M; Scarpa, P; Paltrinieri, S

    2015-04-01

    Quantification of proteinuria is a fundamental step in staging dogs with chronic kidney disease and in monitoring the course of disease or the efficacy of anti-proteinuric treatments. Analytical precision and accuracy of the proteinuria assessment could be affected by several factors such as biological variability, different operators and quality control materials. The aim of this study was to assess whether inter-laboratory variability could affect the urinary protein to creatinine (UPC) ratio and whether this variability may affect patient classification according to the International Renal Interest Society (IRIS) sub-staging system. The same urine samples were analysed in three different laboratories using different instruments and different reagent brands. The results of the three laboratories were highly correlated to each other although urinary protein (UP), urinary creatinine (UC) and the UPC ratio of one laboratory were found to be significantly higher than those of the other two. No significant differences between the other two laboratories were recorded. The concordance in classifying dogs according to the IRIS guidelines was good if all three proteinuria categories were analysed separately or if borderline proteinuric (BP) dogs were included in the proteinuric group, and very good if BP dogs were merged into the non-proteinuric group. The inter-laboratory variability in UPC ratio measurement was not so great as to impede the identification of proteinuric dogs, but may influence the estimation of the magnitude of proteinuria. Copyright © 2015 Elsevier Ltd. All rights reserved.

  19. Quality assurance trials for Ki67 assessment in pathology.

    Science.gov (United States)

    Raap, M; Ließem, S; Rüschoff, J; Fisseler-Eckhoff, A; Reiner, A; Dirnhofer, S; von Wasielewski, R; Kreipe, H

    2017-10-01

    Ki67 is a broadly used proliferation marker in surgical pathology with an obvious need for standardization to improve reproducibility of assessment. Here, we present results of the so far only existing round robin tests on Ki67, organized annually in Germany, Austria, and Switzerland from 2010 to 2015 with up to 160 participating laboratories (QuIP). In each quality assessment trial, eight probes from each breast cancer, neuroendocrine tumor, and malignant lymphoma were compiled on a tissue microarray (TMA). TMAs were stained in the participants' laboratories with antibodies and procedures also applied in their daily routine. Participating pathologists were expected to assign Ki67 values to one of four different categories for each tumor type. All local stainings and evaluations were reassessed by the organizing panel and compared to a preset standard. On average, 95% of participants reached the benchmark of over 80% concordance rates with the Ki67 category pre-established by the panel. Automatization and type of antibody did not affect the success rate. Concordance rates differed between tumor entities being highest in each tumor type with either very high or very low labeling indices. Lower rates were seen for intermediate Ki67 levels. Staining quality improved during the observation period as did inter-observer concordance with 85% of participants achieving excellent agreement (kappa > 0.8) in the first year and over 95% in 2015. In conclusion, regular external quality assurance trials have been established as a tool to improve the reproducibility and reliability of the prognostic and predictive proliferation marker Ki67.

  20. 77 FR 40322 - Oral Rabies Vaccine Trial; Availability of an Environmental Assessment

    Science.gov (United States)

    2012-07-09

    ...] Oral Rabies Vaccine Trial; Availability of an Environmental Assessment AGENCY: Animal and Plant Health... assessment relative to an oral rabies vaccination field trial in New Hampshire, New York, Ohio, Vermont, and West Virginia. The environmental assessment analyzes the use of an experimental rabies vaccine in field...

  1. Interlaboratory comparison of PCR-based identification of Candida and Aspergillus DNA in spiked blood samples.

    Science.gov (United States)

    Reichard, Utz; Buchheidt, Dieter; Lass-Flörl, Cornelia; Loeffler, Juergen; Lugert, Raimond; Ruhnke, Markus; Tintelnot, Kathrin; Weig, Michael; Groß, Uwe

    2012-09-01

    Despite PCR per se being a powerful and sensitive technique, regarding the detection of fungi in patients' blood, no consensus for a standardised PCR protocol yet exists. To complement other ongoing or accomplished studies which tackle this problem, the German Reference Center for Systemic Mycoses conducted an interlaboratory comparison starting with blood samples spiked with fungal cell elements. Altogether, six laboratories using in-house PCR-protocols from Germany and Austria participated in the trial. Blood samples were spiked with vital cells of Candida albicans or Aspergillus fumigatus. Candida was used in the yeast form, whereas Aspergillus cells were either spiked as conidia or as very young germlings, also known as smoo cells. Spiked blood samples contained between 10 and 10 000 cells ml(-1). Depending on the techniques used for fungal cell disruption and DNA-amplification, detection quality was variable between laboratories, but also differed within single laboratories in different trials particularly for samples spiked with less than 100 cells ml(-1). Altogether, at least regarding the detection of A. fumigatus, two of six laboratories showed constant reliable test results also with low fungal cell number spiked samples. Protocols used by these labs do not differ substantially from others. However, as particularities, one protocol included a conventional phenol chloroform extraction during the DNA preparation process and the other included a real time PCR-protocol based on FRET probes. Other laboratory comparisons on the basis of clinical samples should follow to further evaluate the procedures. The difficulties and problems of such trials in general are discussed. © 2012 Blackwell Verlag GmbH.

  2. Determination of maduramicin in feedingstuffs and premixtures by liquid chromatography : development, validation and interlaboratory study

    NARCIS (Netherlands)

    Jong, de J.; Stoisser, B.; Wagner, K.; Tomassen, M.J.H.; Driessen, J.J.M.; Hofman, P.; Putzka, H.A.

    2004-01-01

    A reversed-phase liquid chromatography method for determination of maduramicin in feedingstuffs and premixtures was developed, validated, and interlaboratory studied. The extraction solvent was methanol. Maduramicin was detected at 520 nm after postcolumn derivatization with vanillin. Recovery was

  3. Inter-laboratory optimization of protein extraction, separation, and fluorescent detection of endogenous rice allergens.

    Science.gov (United States)

    Satoh, Rie; Teshima, Reiko; Kitta, Kazumi; Lang, Gang-Hua; Schegg, Kathleen; Blumenthal, Kenneth; Hicks, Leslie; Labory-Carcenac, Bénédicte; Rouquié, David; Herman, Rod A; Herouet-Guicheney, Corinne; Ladics, Gregory S; McClain, Scott; Poulsen, Lars K; Privalle, Laura; Ward, Jason M; Doerrer, Nancy; Rascle, Jean-Baptiste

    2016-07-11

    In rice, several allergens have been identified such as the non-specific lipid transfer protein-1, the α-amylase/trypsin-inhibitors, the α-globulin, the 33 kDa glyoxalase I (Gly I), the 52-63 kDa globulin, and the granule-bound starch synthetase. The goal of the present study was to define optimal rice extraction and detection methods that would allow a sensitive and reproducible measure of several classes of known rice allergens. In a three-laboratory ring-trial experiment, several protein extraction methods were first compared and analyzed by 1D multiplexed SDS-PAGE. In a second phase, an inter-laboratory validation of 2D-DIGE analysis was conducted in five independent laboratories, focusing on three rice allergens (52 kDa globulin, 33 kDa glyoxalase I, and 14-16 kDa α-amylase/trypsin inhibitor family members). The results of the present study indicate that a combination of 1D multiplexed SDS-PAGE and 2D-DIGE methods would be recommended to quantify the various rice allergens.

  4. Evaluation of Brazilian Sugarcane Bagasse Characterization: An Interlaboratory Comparison Study

    Energy Technology Data Exchange (ETDEWEB)

    Sluiter, Justin B.; Chum, Helena; Gomes, Absai C.; Tavares, Renata P. A.; Azevedo, Vinicius; Pimenta, Maria T. B.; Rabelo, Sarita C.; Marabezi, Karen; Curvelo, Antonio A. S.; Alves, Aparecido R.; Garcia, Wokimar T.; Carvalho, Walter; Esteves, Paula J.; Mendonça, Simone; Oliveira, Patricia A.; Ribeiro, José A. A.; Mendes, Thais D.; Vicentin, Marcos P.; Duarte, Celina L.; Mori, Manoel N.

    2016-05-01

    This paper describes a study of the variability of measured composition for a single bulk sugarcane bagasse conducted across eight laboratories using similar analytical methods, with the purpose of determining the expected variation for compositional analysis performed by different laboratories. The results show good agreement of measured composition within a single laboratory, but greater variability when results are compared among laboratories. These interlaboratory variabilities do not seem to be associated with a specific method or technique or any single piece of instrumentation. The summary censored statistics provide mean values and pooled standard deviations as follows: total extractives 6.7% (0.6%), whole ash 1.5% (0.2%), glucan 42.3% (1.2%), xylan 22.3% (0.5%), total lignin 21.3% (0.4%), and total mass closure 99.4% (2.9%).

  5. High Interlaboratory Reprocucibility of DNA Sequence-based Typing of Bacteria in a Multicenter Study

    DEFF Research Database (Denmark)

    Sousa, MA de; Boye, Kit; Lencastre, H de

    2006-01-01

    Current DNA amplification-based typing methods for bacterial pathogens often lack interlaboratory reproducibility. In this international study, DNA sequence-based typing of the Staphylococcus aureus protein A gene (spa, 110 to 422 bp) showed 100% intra- and interlaboratory reproducibility without...... extensive harmonization of protocols for 30 blind-coded S. aureus DNA samples sent to 10 laboratories. Specialized software for automated sequence analysis ensured a common typing nomenclature....

  6. Responsible Translation of Stem Cell Research: An Assessment of Clinical Trial Registration and Publications.

    Science.gov (United States)

    Fung, Moses; Yuan, Yan; Atkins, Harold; Shi, Qian; Bubela, Tania

    2017-05-09

    We assessed the extent to which the publication of clinical trial results of innovative cell-based interventions reflects International Society for Stem Cell Research best practice guidelines. We assessed: (1) characteristics and time to publication of completed trials; (2) quality of reported trials; and (3) results of published trials. We identified and analyzed publications from 1,052 novel stem cell clinical trials: 179 (45.4%) of 393 completed trials had published results; 48 trials were registered by known stem cell tourism clinics, none of which reported results. Completed non-industry-sponsored trials initially published more rapidly, but differences with industry-sponsored trials decreased over time. Most publications reported safety, and 67.3% (mainly early-stage trials) reported positive outcomes. A higher proportion of industry trials reported positive efficacy. Heightened patient expectations for stem cell therapies give rise to ethical obligations for the transparent conduct of clinical trials. Reporting guidelines need to be developed that are specific to early-phase clinical trials. Copyright © 2017 The Author(s). Published by Elsevier Inc. All rights reserved.

  7. Resource utilization implications of treatment were able to be assessed from appropriately reported clinical trial data

    NARCIS (Netherlands)

    Poole-Wilson, Philip A.; Kirwan, Bridget-Anne; Voko, Zoltan; de Brouwer, Sophie; Dunselman, Peter H. J. M.; van Dalen, Frederik J.; Lubsen, Jacobus

    Background and Objective: Published clinical trial data rarely allow assessment of the health care resource utilization implications of treatment. We give an example of how these can be assessed given appropriate tabulation of data. Methods: Data from a trial comparing long-acting nifedipine

  8. 77 FR 49409 - Oral Rabies Vaccine Trial; Availability of an Environmental Assessment and Finding of No...

    Science.gov (United States)

    2012-08-16

    ...] Oral Rabies Vaccine Trial; Availability of an Environmental Assessment and Finding of No Significant... assessment and finding of no significant impact relative to an oral rabies vaccination field trial in New... be prepared. FOR FURTHER INFORMATION CONTACT: Mr. Richard Chipman, Rabies Program Coordinator...

  9. First European interlaboratory comparison of tetracycline and age determination with red fox teeth following oral rabies vaccination programs.

    Science.gov (United States)

    Robardet, Emmanuelle; Demerson, Jean-Michel; Andrieu, Sabrina; Cliquet, Florence

    2012-10-01

    The first European interlaboratory comparison of tetracycline and age determination with red fox (Vulpes vulpes) tooth samples was organized by the European Union Reference Laboratory for rabies. Performance and procedures implemented by member states were compared. These techniques are widely used to monitor bait uptake in European oral rabies vaccination campaigns. A panel of five red fox half-mandibles comprising one weak positive juvenile sample, two positive adult samples, one negative juvenile sample, and one negative adult sample were sent, along with a technical questionnaire, to 12 laboratories participating on a voluntary basis. The results of only three laboratories (25%) were 100% correct. False-negative results were more frequently seen in weak positive juvenile samples (58%) but were infrequent in positive adult samples (4%), probably due to differences in the ease of reading the two groups of teeth. Four laboratories (44%) had correct results for age determination on all samples. Ages were incorrectly identified in both adult and juvenile samples, with 11 and 17% of discordant results, respectively. Analysis of the technical questionnaires in parallel with test results suggested that all laboratories cutting mandible sections between the canine and first premolar obtained false results. All the laboratories using longitudinal rather than transverse sections and those not using a mounting medium also produced false results. Section thickness appeared to affect the results; no mistakes were found in laboratories using sections <150 μm thick. Factors having a potential impact on the success of laboratories were discussed, and recommendations proposed. Such interlaboratory trials underline the importance of using standardized procedures for biomarker detection in oral rabies vaccination campaigns. Several changes can be made to improve analysis quality and increase the comparability of bait uptake frequencies among member states.

  10. Selection and utilization of assessment instruments in substance abuse treatment trials: the National Drug Abuse Treatment Clinical Trials Network experience

    Directory of Open Access Journals (Sweden)

    Rosa C

    2012-07-01

    Full Text Available Carmen Rosa, Udi Ghitza, Betty TaiCenter for the Clinical Trials Network, National Institute on Drug Abuse, Bethesda, MD, USAAbstract: Based on recommendations from a US Institute of Medicine report, the National Institute on Drug Abuse established the National Drug Abuse Treatment Clinical Trials Network (CTN in 1999, to accelerate the translation of science-based addiction treatment research into community-based practice, and to improve the quality of addiction treatment, using science as the vehicle. One of the CTN's primary tasks is to serve as a platform to forge bi-directional communications and collaborations between providers and scientists, to enhance the relevance of research, which generates empirical results that impact practice. Among many obstacles in moving research into real-world settings, this commentary mainly describes challenges and iterative experiences in regard to how the CTN develops its research protocols, with focus on how the CTN study teams select and utilize assessment instruments, which can reasonably balance the interests of both research scientists and practicing providers when applied in CTN trials. This commentary also discusses the process by which the CTN further selects a core set of common assessment instruments that may be applied across all trials, to allow easier cross-study analyses of comparable data.Keywords: addiction, assessment, drug abuse treatment, drug dependence, NIDA Clinical Trials Network, substance use disorder

  11. Results of the Interlaboratory Exercise CNS/CIEMAT-04 Among Environmental Radioactivity Laboratories (Aqueous Solution)

    International Nuclear Information System (INIS)

    Romero Gonzalez, M. L.; Barrera Izquierdo, M.

    2004-01-01

    The document describes the outcome of the CSN/CIEMAT-04 interlaboratory test comparison among environmental radioactivity laboratories. The exercise was organised according to the ISO-43 and the ISO/IUPAC/AOAC Harmonised Protocol for the proficiency testing of analytical laboratories. Following the issue of the European Community Drinking Water Directive 98/83/EC concerning the quality of water for human consumption, the last inter-comparison exercise was organised by using a water sample, in an attempt to evaluate the performance of the laboratories analysing the required radioactivity parameters (H-3, gross alpha and beta activity and residual beta). The sample (a synthetic drinking water), was prepared at the National Laboratory for Ionising Radiation's Standards (CIEMAT), and contained the following radionuclides ''241 Am, ''239+240 Pu, ''90Sr, ''137 Cs, ''3 H y ''40 K. The results of the exercise were computed for 38 participating laboratories, and their analytical performance was assessed using the z-score approach. Robust statistics of the participant's results was applied to obtain the median and standard deviation, including suspected outliers. The exercise has revealed and homogeneous behaviour of laboratories, being statistical parameters from the results close to the reference values. A raised percentage os satisfactory laboratory performance has been obtained for gross alpha, gross beta and residual beta: 85, 97 and 87% respectively. The study has shown that participant laboratories perform radioactive determinations in drinking water samples with satisfactory quality levels. (Author) 16 refs

  12. Results of the Interlaboratory Exercise CNS/CIEMAT-2008 among Environmental Radioactivity Laboratories (Phosphogypsum)

    International Nuclear Information System (INIS)

    Romero, M. L.; Barrera, M.; Valino, F.

    2010-01-01

    The document describes the outcome of the CSN/CIEMAT-2008 interlaboratory test comparison among environmental radioactivity laboratories. The exercise was organised according to the ISO-43 and the ISO/IUPAC/AOAC. Aphosphogypsum material was used as a test sample, in an attempt to evaluate the performance of the laboratories analyzing NORM (Naturally-Occurring Radioactive Materials). The analysis required were: U-238, Th-234, U-234, Th-230, Ra-226, Pb-214, Bi-214, Pb-210, Po-210, Th-232 and U-235, and also gross alpha and gross beta activities. Reference values have been established according to the method of consensus of expert laboratories, with four international laboratories of credited experience: IAEA Seibersdorf, IAEA MEL, IRSN-Orsay and Sta.Teresa ENEA. The results of the exercise were computed for 34 answering laboratories and their analytical performance was assessed using the z-score. Robust statistics of the participants results was applied to obtain the median and standard deviation, to achieve a more complete and objective study of the laboratories performance. The exercise has shown an homogeneous behaviour of laboratories, being statistical parameters from the results close to the assigned Reference Values. Participant laboratories have demonstrated their ability to determine natural radionuclides in phosphogypsum samples (NORM material) with a satisfactory quality level. The scheme has also allowed examining the capability of laboratories to determine the activities of natural radionuclides at the equilibrium. (Author) 10 refs.

  13. Results of an interlaboratory comparison of analytical methods for contaminants of emerging concern in water.

    Science.gov (United States)

    Vanderford, Brett J; Drewes, Jörg E; Eaton, Andrew; Guo, Yingbo C; Haghani, Ali; Hoppe-Jones, Christiane; Schluesener, Michael P; Snyder, Shane A; Ternes, Thomas; Wood, Curtis J

    2014-01-07

    An evaluation of existing analytical methods used to measure contaminants of emerging concern (CECs) was performed through an interlaboratory comparison involving 25 research and commercial laboratories. In total, 52 methods were used in the single-blind study to determine method accuracy and comparability for 22 target compounds, including pharmaceuticals, personal care products, and steroid hormones, all at ng/L levels in surface and drinking water. Method biases ranged from caffeine, NP, OP, and triclosan had false positive rates >15%. In addition, some methods reported false positives for 17β-estradiol and 17α-ethynylestradiol in unspiked drinking water and deionized water, respectively, at levels higher than published predicted no-effect concentrations for these compounds in the environment. False negative rates were also generally contamination, misinterpretation of background interferences, and/or inappropriate setting of detection/quantification levels for analysis at low ng/L levels. The results of both comparisons were collectively assessed to identify parameters that resulted in the best overall method performance. Liquid chromatography-tandem mass spectrometry coupled with the calibration technique of isotope dilution were able to accurately quantify most compounds with an average bias of <10% for both matrixes. These findings suggest that this method of analysis is suitable at environmentally relevant levels for most of the compounds studied. This work underscores the need for robust, standardized analytical methods for CECs to improve data quality, increase comparability between studies, and help reduce false positive and false negative rates.

  14. An inter-laboratory comparison study on transfer, persistence and recovery of DNA from cable ties.

    Science.gov (United States)

    Steensma, Kristy; Ansell, Ricky; Clarisse, Lindy; Connolly, Edward; Kloosterman, Ate D; McKenna, Louise G; van Oorschot, Roland A H; Szkuta, Bianca; Kokshoorn, Bas

    2017-11-01

    To address questions on the activity that led to the deposition of biological traces in a particular case, general information on the probabilities of transfer, persistence and recovery of cellular material in relevant scenarios is necessary. These figures may be derived from experimental data described in forensic literature when conditions relevant to the case were included. The experimental methodology regarding sampling, DNA extraction, DNA typing and profile interpretation that were used to generate these published data may differ from those applied in the case and thus the applicability of the literature data may be questioned. To assess the level of variability that different laboratories obtain when similar exhibits are analysed, we performed an inter-laboratory study between four partner laboratories. Five sets of 20 cable ties bound by different volunteers were distributed to the participating laboratories and sampled and processed according to the in-house protocols. Differences were found for the amount of retrieved DNA, as well as for the reportability and composition of the DNA profiles. These differences also resulted in different probabilities of transfer, persistence and recovery for each laboratory. Nevertheless, when applied to a case example, these differences resulted in similar assignments of weight of evidence given activity-level propositions. Copyright © 2017 Elsevier B.V. All rights reserved.

  15. An interlaboratory comparison of methods for measuring rock matrix porosity

    International Nuclear Information System (INIS)

    Rasilainen, K.; Hellmuth, K.H.; Kivekaes, L.; Ruskeeniemi, T.; Melamed, A.; Siitari-Kauppi, M.

    1996-09-01

    An interlaboratory comparison study was conducted for the available Finnish methods of rock matrix porosity measurements. The aim was first to compare different experimental methods for future applications, and second to obtain quality assured data for the needs of matrix diffusion modelling. Three different versions of water immersion techniques, a tracer elution method, a helium gas through-diffusion method, and a C-14-PMMA method were tested. All methods selected for this study were established experimental tools in the respective laboratories, and they had already been individually tested. Rock samples for the study were obtained from a homogeneous granitic drill core section from the natural analogue site at Palmottu. The drill core section was cut into slabs that were expected to be practically identical. The subsamples were then circulated between the different laboratories using a round robin approach. The circulation was possible because all methods were non-destructive, except the C-14-PMMA method, which was always the last method to be applied. The possible effect of drying temperature on the measured porosity was also preliminarily tested. These measurements were done in the order of increasing drying temperature. Based on the study, it can be concluded that all methods are comparable in their accuracy. The selection of methods for future applications can therefore be based on practical considerations. Drying temperature seemed to have very little effect on the measured porosity, but a more detailed study is needed for definite conclusions. (author) (4 refs.)

  16. A multi-center ring trial of allergen analysis using fluorescent multiplex array technology

    NARCIS (Netherlands)

    King, Eva M.; Filep, Stephanie; Smith, Bryan; Platts-Mills, Thomas; Hamilton, Robert G.; Schmechel, Detlef; Sordillo, Joanne E.; Milton, Donald; van Ree, Ronald; Krop, Esmeralda J. M.; Heederik, Dick J. J.; Metwali, Nervana; Thorne, Peter S.; Zeldin, Darryl C.; Sever, Michelle L.; Calatroni, Agustin; Arbes, Samuel J.; Mitchell, Herman E.; Chapman, Martin D.

    2013-01-01

    Consistent performance of allergen assays is essential to ensure reproducibility of exposure assessments for investigations of asthma and occupational allergic disease. This study evaluated intra- and inter-laboratory reproducibility of a fluorescent multiplex array, which simultaneously measures

  17. Assessment of the quality of reporting of randomized clinical trials in paediatric dentistry journals.

    Science.gov (United States)

    Al-Namankany, Abeer A; Ashley, Paul; Moles, David R; Parekh, Susan

    2009-09-01

    Reporting of randomized controlled trials (RCTs) should be of high quality to support the conclusions reached by the authors. Poor-quality reporting has been associated with an overestimation in intervention efficacy. Within the field of paediatric dentistry, no study has assessed the quality of reporting. The aim of this study was to assess published RCTs in paediatric dental journals between 1985 and 2006 for: (i) whether quality of reporting allows readers to assess the validity of trials; and (ii) whether quality of reporting has improved since the introduction of the Consolidated Standards of Reporting Trials (CONSORT) guidelines. Hand search of the main paediatric dentistry journals; inclusion criteria were: the trial was performed on children, and RCT. CONSORT guidelines were made into an operational checklist. Trials published between 1985 and 1997, and between 1998 and 2006 were compared to determine any improvement since the publication of the CONSORT guidelines. One hundred and seventy-three of 5635 articles met the inclusion criteria. Reporting quality was poor overall and showed heterogeneity. It had improved slightly since the publication of CONSORT. Few trials were reported adequately. The quality of reporting of clinical trials is poor, and often not adequate to allow readers to assess trial validity. Overall quality of reporting has not substantially improved since the publication of CONSORT.

  18. 76 FR 56731 - Oral Rabies Vaccine Trial; Availability of an Environmental Assessment and Finding of No...

    Science.gov (United States)

    2011-09-14

    ...] Oral Rabies Vaccine Trial; Availability of an Environmental Assessment and Finding of No Significant... the Animal and Plant Health Inspection Service relative to an oral rabies vaccination field trial in... INFORMATION CONTACT: Dr. Dennis Slate, Rabies Program Coordinator, Wildlife Services, APHIS, 59 Chennell Drive...

  19. 78 FR 33798 - Oral Rabies Vaccine Trial; Availability of a Supplemental Environmental Assessment

    Science.gov (United States)

    2013-06-05

    ... Inspection Service [Docket No. APHIS-2013-0046] Oral Rabies Vaccine Trial; Availability of a Supplemental... Inspection Service has prepared a supplemental environmental assessment (EA) relative to an oral rabies... analyzes expanding the field trial for an experimental oral rabies vaccine for wildlife to additional areas...

  20. A randomized trial assessing the impact of written information on outpatients' knowledge about and attitude toward randomized clinical trials. The Info Trial Group

    DEFF Research Database (Denmark)

    Kruse, A Y; Kjaergard, L L; Krogsgaard, K

    2000-01-01

    and attitude toward randomized clinical trials was assessed in a randomized, parallel group, evaluator-blinded trial among 415 outpatients. The patients were randomized to the following groups: control (no intervention), leaflet, brochure, or booklet. Knowledge was assessed by a 17-item multiple......To improve the patient education process in clinical research, three information materials describing general aspects of design and conduct of randomized clinical trials were developed. The materials varied in length, reading ability level, and reader appeal. Their influence on knowledge about...... by 0.5 for the control, 1.0 for the leaflet, 1.6 for the brochure, and 1.4 for the booklet. The brochure and the booklet improved the knowledge score significantly compared with the control. The general attitude was positive at entry (mean 71.5 points). Only the booklet significantly increased...

  1. Assessment of Perceived Cost to the Patient and Other Barriers to Clinical Trial Participation

    Science.gov (United States)

    Weckstein, Douglas J.; Thomas, Christian A.; Emery, Ivette F.; Shea, Barbara F.; Fleury, Alison; White, Margaret E.; Chase, Elizabeth; Robinson, Cindy; Frazier, Stacey; Pilar, Christine

    2011-01-01

    Purpose: Less than 5% of patients with cancer participate in trials. Few studies have specifically addressed the role of cost to the patient as an influence on trial participation. Our main purpose was to determine the importance of added cost as a barrier to clinical trial participation in the community setting. Our secondary goal was to determine the most prevalent barriers to trial participation for patients. Patients and Methods: Four community practices in New England issued surveys to consecutive cohorts of patients with cancer. Patients were assessed for eligibility for clinical trials at their practice site. Trial-eligible patients who declined participation were asked to select reasons that contributed to their decision. Results: Surveys were issued to 1,755 patients. Seventy-one percent of all trial-eligible patients returned surveys. Forty-four percent of nonparticipating trial-eligible patients did not recall hearing about clinical trials from their provider. The most common reasons cited by trial-eligible patients for declining trial participation were fear of adverse effects (50%) and discomfort with random assignment (44%). Twenty-eight percent cited concerns about added cost, and 12% noted cost as the most important factor in their decision. Conclusion: Concerns about adverse effects and random assignment were the most common reasons cited by patients declining trial participation in four community oncology practices in New England. Cost considerations were important for a significant proportion of these patients. Many patients eligible for trial participation were not informed by their provider about the availability of research trials. PMID:22211132

  2. 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.

  3. Rethinking risk assessment for emerging technology first-in-human trials.

    Science.gov (United States)

    Genske, Anna; Engel-Glatter, Sabrina

    2016-03-01

    Recent progress in synthetic biology (SynBio) has enabled the development of novel therapeutic opportunities for the treatment of human disease. In the near future, first-in-human trials (FIH) will be indicated. FIH trials mark a key milestone in the translation of medical SynBio applications into clinical practice. Fostered by uncertainty of possible adverse events for trial participants, a variety of ethical concerns emerge with regards to SynBio FIH trials, including 'risk' minimization. These concerns are associated with any FIH trial, however, due to the novelty of the approach, they become more pronounced for medical applications of emerging technologies (emTech) like SynBio. To minimize potential harm for trial participants, scholars, guidelines, regulations and policy makers alike suggest using 'risk assessment' as evaluation tool for such trials. Conversely, in the context of emTech FIH trials, we believe it to be at least questionable to contextualize uncertainty of potential adverse events as 'risk' and apply traditional risk assessment methods. Hence, this issue needs to be discussed to enable alterations of the evaluation process before the translational phase of SynBio applications begins. In this paper, we will take the opportunity to start the debate and highlight how a misunderstanding of the concept of risk, and the possibilities and limitations of risk assessment, respectively, might impair decision-making by the relevant regulatory authorities and research ethics committees, and discuss possible solutions to tackle the issue.

  4. Interlaboratory study for coral Sr/Ca and other element/Ca ratio measurements

    OpenAIRE

    Hathorne, Ed C.; Gagnon, Alex; Felis, Thomas; Adkins, Jess; Asami, Ryuji; Boer, Wim; Caillon, Nicolas; Case, David; Cobb, Kim M.; Douville, Eric; deMenocal, Peter; Eisenhauer, Anton; Garbe-Schönberg, Dieter; Geibert, Walter; Goldstein, Steven L.

    2013-01-01

    The Sr/Ca ratio of coral aragonite is used to reconstruct past sea surface temperature (SST). Twenty-one laboratories took part in an interlaboratory study of coral Sr/Ca measurements. Results show interlaboratory bias can be significant, and in the extreme case could result in a range in SST estimates of 7 degrees C. However, most of the data fall within a narrower range and the Porites coral reference material JCp-1 is now characterized well enough to have a certified Sr/Ca value of 8.838 m...

  5. NAEP 1992 Mathematics State Report for Kentucky. The Trial State Assessment Program.

    Science.gov (United States)

    National Assessment of Educational Progress, Princeton, NJ.

    In 1990, the National Assessment of Educational Progress (NAEP) included a Trial State Assessment which, for the first time in the NAEP's history, made voluntary state-by-state assessments. This 1992 mathematics report marks the first attempt of the National Center for Education Statistics (NCES) to shift to standards-based reporting of National…

  6. The State of Mathematics Achievement in Illinois: The Trial State Assessment at Grade Eight.

    Science.gov (United States)

    National Assessment of Educational Progress, Princeton, NJ.

    In 1990, the National Assessment of Educational Progress (NAEP) included a Trial State Assessment (TSA); for the first time in the NAEP's history, voluntary state-by-state assessments (37 states, the District of Columbia, Guam, and the Virgin Islands) were made. The sample was designed to represent the 8th grade public school population in a state…

  7. NAEP 1992 Mathematics State Report for Utah. The Trial State Assessment Program.

    Science.gov (United States)

    National Assessment of Educational Progress, Princeton, NJ.

    In 1990, the National Assessment of Educational Progress (NAEP) included a Trial State Assessment which, for the first time in the NAEP's history, made voluntary state-by-state assessments. This 1992 mathematics report marks the first attempt of the National Center for Education Statistics to shift to standards-based reporting of National…

  8. The State of Mathematics Achievement in Georgia: The Trial State Assessment at Grade Eight.

    Science.gov (United States)

    National Assessment of Educational Progress, Princeton, NJ.

    In 1990, the National Assessment of Educational Progress (NAEP) included a Trial State Assessment (TSA); for the first time in the NAEP's history, voluntary state-by-state assessments (37 states, the District of Columbia, Guam, and the Virgin Islands) were made. The sample was designed to represent the 8th grade public school population in a state…

  9. The State of Mathematics Achievement in Iowa: The Trial State Assessment at Grade Eight.

    Science.gov (United States)

    National Assessment of Educational Progress, Princeton, NJ.

    In 1990, the National Assessment of Educational Progress (NAEP) included a Trial State Assessment (TSA); for the first time in the NAEP's history, voluntary state-by-state assessments (37 states, the District of Columbia, Guam, and the Virgin Islands) were made. The sample was designed to represent the 8th grade public school population in a state…

  10. NAEP 1992 Mathematics State Report for the District of Columbia. The Trial State Assessment Program.

    Science.gov (United States)

    National Assessment of Educational Progress, Princeton, NJ.

    In 1990, the National Assessment of Educational Progress (NAEP) included a Trial State Assessment which, for the first time in the NAEP's history, made voluntary state-by-state assessments. This 1992 mathematics report marks the first attempt of the National Center for Education Statistics (NCES) to shift to standards-based reporting of National…

  11. NAEP 1992 Mathematics State Report for the Virgin Islands. The Trial State Assessment Program.

    Science.gov (United States)

    National Assessment of Educational Progress, Princeton, NJ.

    In 1990, the National Assessment of Educational Progress (NAEP) included a Trial State Assessment which, for the first time in the NAEP's history, made voluntary state-by-state assessments. This 1992 mathematics report marks the first attempt of the National Center for Education Statistics to shift to standards-based reporting of National…

  12. NAEP 1992 Mathematics State Report for Alabama. The Trial State Assessment Program.

    Science.gov (United States)

    National Assessment of Educational Progress, Princeton, NJ.

    In 1990, the National Assessment of Educational Progress (NAEP) included a Trial State Assessment which, for the first time in the NAEP's history, made voluntary state-by-state assessments. This 1992 mathematics report marks the first attempt of the National Center for Education Statistics (NCES) to shift to standards-based reporting of National…

  13. The State of Mathematics Achievement in Indiana: The Trial State Assessment at Grade Eight.

    Science.gov (United States)

    National Assessment of Educational Progress, Princeton, NJ.

    In 1990, the National Assessment of Educational Progress (NAEP) included a Trial State Assessment (TSA); for the first time in the NAEP's history, voluntary state-by-state assessments (37 states, the District of Columbia, Guam, and the Virgin Islands) were made. The sample was designed to represent the 8th grade public school population in a state…

  14. NAEP 1992 Mathematics State Report for Louisiana. The Trial State Assessment Program.

    Science.gov (United States)

    National Assessment of Educational Progress, Princeton, NJ.

    In 1990, the National Assessment of Educational Progress (NAEP) included a Trial State Assessment which, for the first time in the NAEP's history, made voluntary state-by-state assessments. This 1992 mathematics report marks the first attempt of the National Center for Education Statistics (NCES) to shift to standards-based reporting of National…

  15. NAEP 1992 Mathematics State Report for Tennessee. The Trial State Assessment Program.

    Science.gov (United States)

    National Assessment of Educational Progress, Princeton, NJ.

    In 1990, the National Assessment of Educational Progress (NAEP) included a Trial State Assessment which, for the first time in the NAEP's history, made voluntary state-by-state assessments. This 1992 mathematics report marks the first attempt of the National Center for Education Statistics to shift to standards-based reporting of National…

  16. NAEP 1992 Mathematics State Report for Colorado. The Trial State Assessment Program.

    Science.gov (United States)

    National Assessment of Educational Progress, Princeton, NJ.

    In 1990, the National Assessment of Educational Progress (NAEP) included a Trial State Assessment which, for the first time in the NAEP's history, made voluntary state-by-state assessments. This 1992 mathematics report marks the first attempt of the National Center for Education Statistics (NCES) to shift to standards-based reporting of National…

  17. NAEP 1992 Mathematics State Report for Mississippi. The Trial State Assessment Program.

    Science.gov (United States)

    National Assessment of Educational Progress, Princeton, NJ.

    In 1990, the National Assessment of Educational Progress (NAEP) included a Trial State Assessment which, for the first time in the NAEP's history, made voluntary state-by-state assessments. This 1992 mathematics report marks the first attempt of the National Center for Education Statistics (NCES) to shift to standards-based reporting of National…

  18. NAEP 1992 Mathematics State Report for Missouri. The Trial State Assessment Program.

    Science.gov (United States)

    National Assessment of Educational Progress, Princeton, NJ.

    In 1990, the National Assessment of Educational Progress (NAEP) included a Trial State Assessment which, for the first time in the NAEP's history, made voluntary state-by-state assessments. This 1992 mathematics report marks the first attempt of the National Center for Education Statistics to shift to standards-based reporting of National…

  19. NAEP 1992 Mathematics State Report for Minnesota. The Trial State Assessment Program.

    Science.gov (United States)

    National Assessment of Educational Progress, Princeton, NJ.

    In 1990, the National Assessment of Educational Progress (NAEP) included a Trial State Assessment which, for the first time in the NAEP's history, made voluntary state-by-state assessments. This 1992 mathematics report marks the first attempt of the National Center for Education Statistics (NCES) to shift to standards-based reporting of National…

  20. NAEP 1992 Mathematics State Report for Oklahoma. The Trial State Assessment Program.

    Science.gov (United States)

    National Assessment of Educational Progress, Princeton, NJ.

    In 1990, the National Assessment of Educational Progress (NAEP) included a Trial State Assessment which, for the first time in the NAEP's history, made voluntary state-by-state assessments. This 1992 mathematics report marks the first attempt of the National Center for Education Statistics to shift to standards-based reporting of National…

  1. NAEP 1992 Mathematics State Report for New York. The Trial State Assessment Program.

    Science.gov (United States)

    National Assessment of Educational Progress, Princeton, NJ.

    In 1990, the National Assessment of Educational Progress (NAEP) included a Trial State Assessment which, for the first time in the NAEP's history, made voluntary state-by-state assessments. This 1992 mathematics report marks the first attempt of the National Center for Education Statistics to shift to standards-based reporting of National…

  2. The State of Mathematics Achievement in Colorado: The Trial State Assessment at Grade Eight.

    Science.gov (United States)

    National Assessment of Educational Progress, Princeton, NJ.

    In 1990, the National Assessment of Educational Progress (NAEP) included a Trial State Assessment (TSA); for the first time in the NAEP's history, voluntary state-by-state assessments (37 states, the District of Columbia, Guam, and the Virgin Islands) were made. The sample was designed to represent the 8th grade public school population in a state…

  3. NAEP 1992 Mathematics State Report for Massachusetts. The Trial State Assessment Program.

    Science.gov (United States)

    National Assessment of Educational Progress, Princeton, NJ.

    In 1990, the National Assessment of Educational Progress (NAEP) included a Trial State Assessment which, for the first time in the NAEP's history, made voluntary state-by-state assessments. This 1992 mathematics report marks the first attempt of the National Center for Education Statistics (NCES) to shift to standards-based reporting of National…

  4. NAEP 1992 Mathematics State Report for New Hampshire. The Trial State Assessment Program.

    Science.gov (United States)

    National Assessment of Educational Progress, Princeton, NJ.

    In 1990, the National Assessment of Educational Progress (NAEP) included a Trial State Assessment which, for the first time in the NAEP's history, made voluntary state-by-state assessments. This 1992 mathematics report marks the first attempt of the National Center for Education Statistics to shift to standards-based reporting of National…

  5. The State of Mathematics Achievement in Alabama: The Trial State Assessment at Grade Eight.

    Science.gov (United States)

    National Assessment of Educational Progress, Princeton, NJ.

    In 1990, the National Assessment of Educational Progress (NAEP) included a Trial State Assessment (TSA); for the first time in the NAEP's history, voluntary state-by-state assessments (37 states, the District of Columbia, Guam, and the Virgin Islands) were made. The sample was designed to represent the 8th grade public school population in a state…

  6. NAEP 1992 Mathematics State Report for Indiana. The Trial State Assessment Program.

    Science.gov (United States)

    National Assessment of Educational Progress, Princeton, NJ.

    In 1990, the National Assessment of Educational Progress (NAEP) included a Trial State Assessment which, for the first time in the NAEP's history, made voluntary state-by-state assessments. This 1992 mathematics report marks the first attempt of the National Center for Education Statistics (NCES) to shift to standards-based reporting of National…

  7. NAEP 1992 Mathematics State Report for Delaware. The Trial State Assessment Program.

    Science.gov (United States)

    National Assessment of Educational Progress, Princeton, NJ.

    In 1990, the National Assessment of Educational Progress (NAEP) included a Trial State Assessment which, for the first time in the NAEP's history, made voluntary state-by-state assessments. This 1992 mathematics report marks the first attempt of the National Center for Education Statistics (NCES) to shift to standards-based reporting of National…

  8. The State of Mathematics Achievement in Idaho: The Trial State Assessment at Grade Eight.

    Science.gov (United States)

    National Assessment of Educational Progress, Princeton, NJ.

    In 1990, the National Assessment of Educational Progress (NAEP) included a Trial State Assessment (TSA); for the first time in the NAEP's history, voluntary state-by-state assessments (37 states, the District of Columbia, Guam, and the Virgin Islands) were made. The sample was designed to represent the 8th grade public school population in a state…

  9. NAEP 1992 Mathematics State Report for Arkansas. The Trial State Assessment Program.

    Science.gov (United States)

    National Assessment of Educational Progress, Princeton, NJ.

    In 1990, the National Assessment of Educational Progress (NAEP) included a Trial State Assessment which, for the first time in the NAEP's history, made voluntary state-by-state assessments. This 1992 mathematics report marks the first attempt of the National Center for Education Statistics (NCES) to shift to standards-based reporting of National…

  10. The State of Mathematics Achievement in Hawaii: The Trial State Assessment at Grade Eight.

    Science.gov (United States)

    National Assessment of Educational Progress, Princeton, NJ.

    In 1990, the National Assessment of Educational Progress (NAEP) included a Trial State Assessment (TSA); for the first time in the NAEP's history, voluntary state-by-state assessments (37 states, the District of Columbia, Guam, and the Virgin Islands) were made. The sample was designed to represent the 8th grade public school population in a state…

  11. NAEP 1992 Mathematics State Report for New Mexico. The Trial State Assessment Program.

    Science.gov (United States)

    National Assessment of Educational Progress, Princeton, NJ.

    In 1990, the National Assessment of Educational Progress (NAEP) included a Trial State Assessment which, for the first time in the NAEP's history, made voluntary state-by-state assessments. This 1992 mathematics report marks the first attempt of the National Center for Education Statistics to shift to standards-based reporting of National…

  12. NAEP 1992 Mathematics State Report for Idaho. The Trial State Assessment Program.

    Science.gov (United States)

    National Assessment of Educational Progress, Princeton, NJ.

    In 1990, the National Assessment of Educational Progress (NAEP) included a Trial State Assessment which, for the first time in the NAEP's history, made voluntary state-by-state assessments. This 1992 mathematics report marks the first attempt of the National Center for Education Statistics (NCES) to shift to standards-based reporting of National…

  13. NAEP 1992 Mathematics State Report for Ohio. The Trial State Assessment Program.

    Science.gov (United States)

    National Assessment of Educational Progress, Princeton, NJ.

    In 1990, the National Assessment of Educational Progress (NAEP) included a Trial State Assessment which, for the first time in the NAEP's history, made voluntary state-by-state assessments. This 1992 mathematics report marks the first attempt of the National Center for Education Statistics to shift to standards-based reporting of National…

  14. NAEP 1992 Mathematics State Report for Wyoming. The Trial State Assessment Program.

    Science.gov (United States)

    National Assessment of Educational Progress, Princeton, NJ.

    In 1990, the National Assessment of Educational Progress (NAEP) included a Trial State Assessment which, for the first time in the NAEP's history, made voluntary state-by-state assessments. This 1992 mathematics report marks the first attempt of the National Center for Education Statistics to shift to standards-based reporting of National…

  15. NAEP 1992 Mathematics State Report for South Carolina. The Trial State Assessment Program.

    Science.gov (United States)

    National Assessment of Educational Progress, Princeton, NJ.

    In 1990, the National Assessment of Educational Progress (NAEP) included a Trial State Assessment which, for the first time in the NAEP's history, made voluntary state-by-state assessments. This 1992 mathematics report marks the first attempt of the National Center for Education Statistics to shift to standards-based reporting of National…

  16. NAEP 1992 Mathematics State Report for West Virginia. The Trial State Assessment Program.

    Science.gov (United States)

    National Assessment of Educational Progress, Princeton, NJ.

    In 1990, the National Assessment of Educational Progress (NAEP) included a Trial State Assessment which, for the first time in the NAEP's history, made voluntary state-by-state assessments. This 1992 mathematics report marks the first attempt of the National Center for Education Statistics to shift to standards-based reporting of National…

  17. The State of Mathematics Achievement in Florida: The Trial State Assessment at Grade Eight.

    Science.gov (United States)

    National Assessment of Educational Progress, Princeton, NJ.

    In 1990, the National Assessment of Educational Progress (NAEP) included a Trial State Assessment (TSA); for the first time in the NAEP's history, voluntary state-by-state assessments (37 states, the District of Columbia, Guam, and the Virgin Islands) were made. The sample was designed to represent the 8th grade public school population in a state…

  18. NAEP 1992 Mathematics State Report for Georgia. The Trial State Assessment Program.

    Science.gov (United States)

    National Assessment of Educational Progress, Princeton, NJ.

    In 1990, the National Assessment of Educational Progress (NAEP) included a Trial State Assessment which, for the first time in the NAEP's history, made voluntary state-by-state assessments. This 1992 mathematics report marks the first attempt of the National Center for Education Statistics (NCES) to shift to standards-based reporting of National…

  19. NAEP 1992 Mathematics State Report for Hawaii. The Trial State Assessment Program.

    Science.gov (United States)

    National Assessment of Educational Progress, Princeton, NJ.

    In 1990, the National Assessment of Educational Progress (NAEP) included a Trial State Assessment which, for the first time in the NAEP's history, made voluntary state-by-state assessments. This 1992 mathematics report marks the first attempt of the National Center for Education Statistics (NCES) to shift to standards-based reporting of National…

  20. NAEP 1992 Mathematics State Report for Florida. The Trial State Assessment Program.

    Science.gov (United States)

    National Assessment of Educational Progress, Princeton, NJ.

    In 1990, the National Assessment of Educational Progress (NAEP) included a Trial State Assessment which, for the first time in the NAEP's history, made voluntary state-by-state assessments. This 1992 mathematics report marks the first attempt of the National Center for Education Statistics (NCES) to shift to standards-based reporting of National…

  1. NAEP 1992 Mathematics State Report for Iowa. The Trial State Assessment Program.

    Science.gov (United States)

    National Assessment of Educational Progress, Princeton, NJ.

    In 1990, the National Assessment of Educational Progress (NAEP) included a Trial State Assessment which, for the first time in the NAEP's history, made voluntary state-by-state assessments. This 1992 mathematics report marks the first attempt of the National Center for Education Statistics (NCES) to shift to standards-based reporting of National…

  2. NAEP 1992 Mathematics State Report for Arizona. The Trial State Assessment Program.

    Science.gov (United States)

    National Assessment of Educational Progress, Princeton, NJ.

    In 1990, the National Assessment of Educational Progress (NAEP) included a Trial State Assessment which, for the first time in the NAEP's history, made voluntary state-by-state assessments. This 1992 mathematics report marks the first attempt of the National Center for Education Statistics (NCES) to shift to standards-based reporting of National…

  3. The State of Mathematics Achievement in Connecticut: The Trial State Assessment at Grade Eight.

    Science.gov (United States)

    National Assessment of Educational Progress, Princeton, NJ.

    In 1990, the National Assessment of Educational Progress (NAEP) included a Trial State Assessment (TSA); for the first time in the NAEP's history, voluntary state-by-state assessments (37 states, the District of Columbia, Guam, and the Virgin Islands) were made. The sample was designed to represent the 8th grade public school population in a state…

  4. NAEP 1992 Mathematics State Report for Nebraska. The Trial State Assessment Program.

    Science.gov (United States)

    National Assessment of Educational Progress, Princeton, NJ.

    In 1990, the National Assessment of Educational Progress (NAEP) included a Trial State Assessment which, for the first time in the NAEP's history, made voluntary state-by-state assessments. This 1992 mathematics report marks the first attempt of the National Center for Education Statistics to shift to standards-based reporting of National…

  5. NAEP 1992 Mathematics State Report for Maine. The Trial State Assessment Program.

    Science.gov (United States)

    National Assessment of Educational Progress, Princeton, NJ.

    In 1990, the National Assessment of Educational Progress (NAEP) included a Trial State Assessment which, for the first time in the NAEP's history, made voluntary state-by-state assessments. This 1992 mathematics report marks the first attempt of the National Center for Education Statistics (NCES) to shift to standards-based reporting of National…

  6. NAEP 1992 Mathematics State Report for Michigan. The Trial State Assessment Program.

    Science.gov (United States)

    National Assessment of Educational Progress, Princeton, NJ.

    In 1990, the National Assessment of Educational Progress (NAEP) included a Trial State Assessment which, for the first time in the NAEP's history, made voluntary state-by-state assessments. This 1992 mathematics report marks the first attempt of the National Center for Education Statistics (NCES) to shift to standards-based reporting of National…

  7. NAEP 1992 Mathematics State Report for Guam. The Trial State Assessment Program.

    Science.gov (United States)

    National Assessment of Educational Progress, Princeton, NJ.

    In 1990, the National Assessment of Educational Progress (NAEP) included a Trial State Assessment which, for the first time in the NAEP's history, made voluntary state-by-state assessments. This 1992 mathematics report marks the first attempt of the National Center for Education Statistics to shift to standards-based reporting of National…

  8. NAEP 1992 Mathematics State Report for New Jersey. The Trial State Assessment Program.

    Science.gov (United States)

    National Assessment of Educational Progress, Princeton, NJ.

    In 1990, the National Assessment of Educational Progress (NAEP) included a Trial State Assessment which, for the first time in the NAEP's history, made voluntary state-by-state assessments. This 1992 mathematics report marks the first attempt of the National Center for Education Statistics to shift to standards-based reporting of National…

  9. NAEP 1992 Mathematics State Report for California. The Trial State Assessment Program.

    Science.gov (United States)

    National Assessment of Educational Progress, Princeton, NJ.

    In 1990, the National Assessment of Educational Progress (NAEP) included a Trial State Assessment which, for the first time in the NAEP's history, made voluntary state-by-state assessments. This 1992 mathematics report marks the first attempt of the National Center for Education Statistics (NCES) to shift to standards-based reporting of National…

  10. The State of Mathematics Achievement in Arkansas: The Trial State Assessment at Grade Eight.

    Science.gov (United States)

    National Assessment of Educational Progress, Princeton, NJ.

    In 1990, the National Assessment of Educational Progress (NAEP) included a Trial State Assessment (TSA); for the first time in the NAEP's history, voluntary state-by-state assessments (37 states, the District of Columbia, Guam, and the Virgin Islands) were made. The sample was designed to represent the 8th grade public school population in a state…

  11. NAEP 1992 Mathematics State Report for Connecticut. The Trial State Assessment Program.

    Science.gov (United States)

    National Assessment of Educational Progress, Princeton, NJ.

    In 1990, the National Assessment of Educational Progress (NAEP) included a Trial State Assessment which, for the first time in the NAEP's history, made voluntary state-by-state assessments. This 1992 mathematics report marks the first attempt of the National Center for Education Statistics (NCES) to shift to standards-based reporting of National…

  12. The State of Mathematics Achievement in Arizona: The Trial State Assessment at Grade Eight.

    Science.gov (United States)

    National Assessment of Educational Progress, Princeton, NJ.

    In 1990, the National Assessment of Educational Progress (NAEP) included a Trial State Assessment (TSA); for the first time in the NAEP's history, voluntary state-by-state assessments (37 states, the District of Columbia, Guam, and the Virgin Islands) were made. The sample was designed to represent the 8th grade public school population in a state…

  13. NAEP 1992 Mathematics State Report for Virginia. The Trial State Assessment Program.

    Science.gov (United States)

    National Assessment of Educational Progress, Princeton, NJ.

    In 1990, the National Assessment of Educational Progress (NAEP) included a Trial State Assessment which, for the first time in the NAEP's history, made voluntary state-by-state assessments. This 1992 mathematics report marks the first attempt of the National Center for Education Statistics to shift to standards-based reporting of National…

  14. NAEP 1992 Mathematics State Report for North Carolina. The Trial State Assessment Program.

    Science.gov (United States)

    National Assessment of Educational Progress, Princeton, NJ.

    In 1990, the National Assessment of Educational Progress (NAEP) included a Trial State Assessment which, for the first time in the NAEP's history, made voluntary state-by-state assessments. This 1992 mathematics report marks the first attempt of the National Center for Education Statistics to shift to standards-based reporting of National…

  15. The State of Mathematics Achievement in Delaware: The Trial State Assessment at Grade Eight.

    Science.gov (United States)

    National Assessment of Educational Progress, Princeton, NJ.

    In 1990, the National Assessment of Educational Progress (NAEP) included a Trial State Assessment (TSA); for the first time in the NAEP's history, voluntary state-by-state assessments (37 states, the District of Columbia, Guam, and the Virgin Islands) were made. The sample was designed to represent the 8th grade public school population in a state…

  16. The State of Mathematics Achievement in California: The Trial State Assessment at Grade Eight.

    Science.gov (United States)

    National Assessment of Educational Progress, Princeton, NJ.

    In 1990, the National Assessment of Educational Progress (NAEP) included a Trial State Assessment (TSA); for the first time in the NAEP's history, voluntary state-by-state assessments (37 states, the District of Columbia, Guam, and the Virgin Islands) were made. The sample was designed to represent the 8th grade public school population in a state…

  17. NAEP 1992 Mathematics State Report for Wisconsin. The Trial State Assessment Program.

    Science.gov (United States)

    National Assessment of Educational Progress, Princeton, NJ.

    In 1990, the National Assessment of Educational Progress (NAEP) included a Trial State Assessment which, for the first time in the NAEP's history, made voluntary state-by-state assessments. This 1992 mathematics report marks the first attempt of the National Center for Education Statistics to shift to standards-based reporting of National…

  18. NAEP 1992 Mathematics State Report for North Dakota. The Trial State Assessment Program.

    Science.gov (United States)

    National Assessment of Educational Progress, Princeton, NJ.

    In 1990, the National Assessment of Educational Progress (NAEP) included a Trial State Assessment which, for the first time in the NAEP's history, made voluntary state-by-state assessments. This 1992 mathematics report marks the first attempt of the National Center for Education Statistics to shift to standards-based reporting of National…

  19. NAEP 1992 Mathematics State Report for Rhode Island. The Trial State Assessment Program.

    Science.gov (United States)

    National Assessment of Educational Progress, Princeton, NJ.

    In 1990, the National Assessment of Educational Progress (NAEP) included a Trial State Assessment which, for the first time in the NAEP's history, made voluntary state-by-state assessments. This 1992 mathematics report marks the first attempt of the National Center for Education Statistics to shift to standards-based reporting of National…

  20. NAEP 1992 Mathematics State Report for Texas. The Trial State Assessment Program.

    Science.gov (United States)

    National Assessment of Educational Progress, Princeton, NJ.

    In 1990, the National Assessment of Educational Progress (NAEP) included a Trial State Assessment which, for the first time in the NAEP's history, made voluntary state-by-state assessments. This 1992 mathematics report marks the first attempt of the National Center for Education Statistics to shift to standards-based reporting of National…

  1. NAEP 1992 Mathematics State Report for Pennsylvania. The Trial State Assessment Program.

    Science.gov (United States)

    National Assessment of Educational Progress, Princeton, NJ.

    In 1990, the National Assessment of Educational Progress (NAEP) included a Trial State Assessment which, for the first time in the NAEP's history, made voluntary state-by-state assessments. This 1992 mathematics report marks the first attempt of the National Center for Education Statistics to shift to standards-based reporting of National…

  2. NAEP 1992 Mathematics State Report for Maryland. The Trial State Assessment Program.

    Science.gov (United States)

    National Assessment of Educational Progress, Princeton, NJ.

    In 1990, the National Assessment of Educational Progress (NAEP) included a Trial State Assessment which, for the first time in the NAEP's history, made voluntary state-by-state assessments. This 1992 mathematics report marks the first attempt of the National Center for Education Statistics (NCES) to shift to standards-based reporting of National…

  3. Assessing the remedy: the case for contracts in clinical trials.

    Science.gov (United States)

    Edwards, Sarah J L

    2011-04-01

    Current orthodoxy in research ethics assumes that subjects of clinical trials reserve rights to withdraw at any time and without giving any reason. This view sees the right to withdraw as a simple extension of the right to refuse to participate all together. In this paper, however, I suggest that subjects should assume some responsibilities for the internal validity of the trial at consent and that these responsibilities should be captured by contract. This would allow the researcher to impose a penalty on the subject if he were to withdraw without good reason and on a whim. This proposal still leaves open the possibility of withdrawing without penalty when it is in the subject's best interests to do so. Giving researchers recourse to legal remedy may now be necessary to protect the science, as existing methods used to increase retention are inadequate for one reason or another.

  4. Assessment of rosacea severity: A review of evaluation methods used in clinical trials.

    Science.gov (United States)

    Hopkinson, Dennis; Moradi Tuchayi, Sara; Alinia, Hossein; Feldman, Steven R

    2015-07-01

    Novel rosacea treatments are needed. Assessment methodologies for clinical trials of rosacea treatments are not standardized and are relatively inadequate. To determine the efficacy of new treatments, a valid and reliable assessment methodology is needed. We sought to determine the assessment methodologies used in clinical trials for rosacea treatments, to demonstrate the need for a valid and reliable assessment tool, and to describe the relevant properties of such a tool. PubMed and MEDLINE were searched for clinical trials of rosacea treatments since January 1, 1985. In all, 32 clinical trials met inclusion criteria. Assessment methodologies were highly variable, and standardized assessment methodologies were used in only 3 studies. The various manifestations of rosacea were assessed inconsistently. Eighteen articles could not be included as a result of lack of access to the full text. The diverse methodologies make the assessment of novel treatments and comparison of treatments difficult. A valid and reliable assessment tool is needed to properly assess novel treatments to improve the management of rosacea. Copyright © 2015 American Academy of Dermatology, Inc. Published by Elsevier Inc. All rights reserved.

  5. Interlaboratory comparison of three microbial source tracking quantitative polymerase chain reaction (qPCR) assays from fecal-source and environmental samples

    Science.gov (United States)

    Stelzer, Erin A.; Strickler, Kriston M.; Schill, William B.

    2012-01-01

    During summer and early fall 2010, 15 river samples and 6 fecal-source samples were collected in West Virginia. These samples were analyzed by three laboratories for three microbial source tracking (MST) markers: AllBac, a general fecal indicator; BacHum, a human-associated fecal indicator; and BoBac, a ruminant-associated fecal indicator. MST markers were analyzed by means of the quantitative polymerase chain reaction (qPCR) method. The aim was to assess interlaboratory precision when the three laboratories used the same MST marker and shared deoxyribonucleic acid (DNA) extracts of the samples, but different equipment, reagents, and analyst experience levels. The term assay refers to both the markers and the procedure differences listed above. Interlaboratory precision was best for all three MST assays when using the geometric mean absolute relative percent difference (ARPD) and Friedman's statistical test as a measure of interlaboratory precision. Adjustment factors (one for each MST assay) were calculated using results from fecal-source samples analyzed by all three laboratories and applied retrospectively to sample concentrations to account for differences in qPCR results among labs using different standards and procedures. Following the application of adjustment factors to qPCR results, ARPDs were lower; however, statistically significant differences between labs were still observed for the BacHum and BoBac assays. This was a small study and two of the MST assays had 52 percent of samples with concentrations at or below the limit of accurate quantification; hence, more testing could be done to determine if the adjustment factors would work better if the majority of sample concentrations were above the quantification limit.

  6. An ECVAG inter-laboratory validation study of the comet assay

    DEFF Research Database (Denmark)

    Ersson, Clara; Møller, Peter; Forchhammer, Lykke

    2013-01-01

    The alkaline comet assay is an established, sensitive method extensively used in biomonitoring studies. This method can be modified to measure a range of different types of DNA damage. However, considerable differences in the protocols used by different research groups affect the inter-laboratory...

  7. Interlaboratory validation of small-scale solubility and dissolution measurements of poorly water-soluble drugs

    DEFF Research Database (Denmark)

    Andersson, Sara B. E.; Alvebratt, Caroline; Bevernage, Jan

    2016-01-01

    The purpose of this study was to investigate the interlaboratory variability in determination of apparent solubility (Sapp) and intrinsic dissolution rate (IDR) using a miniaturized dissolution instrument. Three poorly water-soluble compounds were selected as reference compounds and measured at m...

  8. An interlaboratory comparison between similar methods for determination of melatonin, cortisol and testosterone in saliva

    DEFF Research Database (Denmark)

    Jensen, Marie Aarrebo; Mortier, Leen; Koh, Eitetsu

    2014-01-01

    An interlaboratory comparison study for melatonin, cortisol and testosterone in saliva in which five laboratories participated is reported in this study. Each laboratory blindly measured eight samples prepared from natural saliva spiked with melatonin, cortisol and testosterone in the range 0-579...

  9. Detection of antigen in sera of patients with invasive aspergillosis : Intra- and interlaboratory reproducibility

    NARCIS (Netherlands)

    Verweij, PE; Erjavec, Z; Sluiters, W; Goessens, W; Rozenberg-Arska, M; Debets-Ossenkopp, YJ; Guiot, HFL; Meis, JFGM

    The intra-and interlaboratory reproducibilities of a commercial sandwich enzyme-linked immunosorbent assay (ELISA) for the detection of Aspergillus galactomannan in serum (Platelia Aspergillus; Sanofi Diagnostics Pasteur, Marnes-La-Coquette, France) were evaluated in six laboratories of university

  10. EU Interlaboratory comparison study veterinary-X Bacteriological detection of Salmonella in pig faeces

    NARCIS (Netherlands)

    Kuijpers AFA; Veenman C; Mooijman KA; LZO

    2007-01-01

    The European National Reference Laboratories (NRLs) for Salmonella were able to detect high and low levels of Salmonella in pig faeces. This is shown in the 10th interlaboratory comparison study, in which 27 laboratories participated. The goal of the study, organised by the Community Reference

  11. Use of an excess variance approach for the certification of reference materials by interlaboratory comparison

    International Nuclear Information System (INIS)

    Crozet, M.; Rigaux, C.; Roudil, D.; Tuffery, B.; Ruas, A.; Desenfant, M.

    2014-01-01

    In the nuclear field, the accuracy and comparability of analytical results are crucial to insure correct accountancy, good process control and safe operational conditions. All of these require reliable measurements based on reference materials whose certified values must be obtained by robust metrological approaches according to the requirements of ISO guides 34 and 35. The data processing of the characterization step is one of the key steps of a reference material production process. Among several methods, the use of interlaboratory comparison results for reference material certification is very common. The DerSimonian and Laird excess variance approach, described and implemented in this paper, is a simple and efficient method for the data processing of interlaboratory comparison results for reference material certification. By taking into account not only the laboratory uncertainties but also the spread of the individual results into the calculation of the weighted mean, this approach minimizes the risk to get biased certified values in the case where one or several laboratories either underestimate their measurement uncertainties or do not identify all measurement biases. This statistical method has been applied to a new CETAMA plutonium reference material certified by interlaboratory comparison and has been compared to the classical weighted mean approach described in ISO Guide 35. This paper shows the benefits of using an 'excess variance' approach for the certification of reference material by interlaboratory comparison. (authors)

  12. Interlaboratory comparison of measuring results of magnetic field near 400 kV overhead power line

    Directory of Open Access Journals (Sweden)

    Grbić Maja

    2012-01-01

    Full Text Available The paper presents a comparison of measured results of magnetic field near 400 kV overhead power lines obtained by three laboratories. This interlaboratory comparison was performed to ensure confidence in the quality of the test results. The measured results were analyzed with standard methods, using En number, based on which the evaluation of the laboratories was performed.

  13. An inter-laboratory stability study of roll-to-roll coated flexible polymer solar modules

    DEFF Research Database (Denmark)

    Gevorgyan, Suren; Medford, Andrew James; Bundgaard, Eva

    2011-01-01

    O (nanoparticulate, thin film) were employed as electron transport layers. The devices were all tested at Risø DTU and the functional devices were subjected to an inter-laboratory study involving the performance and the stability of modules over time in the dark, under light soaking and outdoor conditions. 24...

  14. 78 FR 49444 - Oral Rabies Vaccine Trial; Availability of a Supplement to an Environmental Assessment and...

    Science.gov (United States)

    2013-08-14

    ...] Oral Rabies Vaccine Trial; Availability of a Supplement to an Environmental Assessment and Finding of... supplement to an environmental assessment and finding of no significant impact relative to an oral rabies.... Richard Chipman, Rabies Program Coordinator, Wildlife Services, APHIS, 59 Chennell Drive, Suite 7, Concord...

  15. Trials

    Directory of Open Access Journals (Sweden)

    Michele Fornaro

    2010-01-01

    Full Text Available Mental Retardation (MR is a developmental disability characterized by impairments in adaptive daily life skills and difficulties in social and interpersonal functioning. Since multiple causes may contribute to MR, associated clinical pictures may vary accordingly. Nevertheless, when psychiatric disorders as Treatment Resistant Depression (TRD and/or alcohol abuse co-exist, their proper detection and management is often troublesome, essentially due to a limited vocabulary MR people could use to describe their symptoms, feelings and concerns, and the lack of reliable screening tools. Furthermore, MR people are among the most medicated subjects, with (over prescription of antidepressants and/or typical antipsychotics being the rule rather than exception. Thus, treatment resistance or even worsening of depression, constitute frequent occurrences. This report describes the case of a person with MR who failed to respond to repetitive trials of antidepressant monotherapies, finally recovering using aripiprazole to fluvoxamine augmentation upon consideration of a putative bipolar diathesis for “agitated” TRD. Although further controlled investigations are needed to assess a putative bipolar diathesis in some cases of MR associated to TRD, prudence is advised in the long-term prescription of antidepressant monotherapies in such conditions.

  16. Results of the Interlaboratory Exercise CNS/CIEMAT-05 among Environmental Radioactivity Laboratories (Vegetable Ash)

    International Nuclear Information System (INIS)

    Romero Gonzalez, M. L.; Barrera Izquierdo, M.; Valino Garcia, F.

    2006-01-01

    The document describes the outcome of the CSN/CIEMAT-05 interlaboratory test comparison among environmental radioactivity laboratories. The exercise was organised according to the ISO-43 and the IUPAC I nternational harmonised protocol for the proficiency testing of analytical chemistry laboratories . The exercise has been designed to evaluate the capability of national laboratories to determine environmental levels of radionuclides in vegetable ash samples. The sample has been prepared by the Environmental Radiation Laboratory, from the University of Barcelona, and it contains the following radionuclides: Sr-90, Pu-238, Am-241, Th-230, Pb-210, U-238, Ra-226, K-40, Ra-228, TI-208, Cs- 137 and Co-60. Reference values have been established TROUGH the kind collaboration of three international laboratories of recognized experience: IAEA MEL and IRSN-Orsay. The results of the exercise were computed for 35 participating laboratories and their analytical performance was assessed using the z-score approach. Robust statistics of the participant's results was applied to obtain the median and standard deviation, to achieve a more complete and objetiva study of the laboratories' performance. Some difficulties encountered to dissolve the test sample caused a lower response of analyses involving radiochemical separation, thus some laboratories couldn't apply their routine methods and no conclusions on PU-238, Am-241 and Th-230 performances have been obtained. The exercise has revealed an homogeneous behaviour of laboratories, being statistical parameters from the results close to the reference values. The study has shown that participant laboratories perform radioactive determinations in vegetable ash samples with satisfactory quality levels. (Author) 6 refs

  17. Standardisation of EGFR FISH in colorectal cancer: results of an international interlaboratory reproducibility ring study.

    Science.gov (United States)

    Sartore-Bianchi, Andrea; Fieuws, Steffen; Veronese, Silvio; Moroni, Mauro; Personeni, Nicola; Frattini, Milo; Torri, Valter; Cappuzzo, Federico; Vander Borght, Sara; Martin, Vittoria; Skokan, Margaret; Santoro, Armando; Gambacorta, Marcello; Tejpar, Sabine; Varella-Garcia, Marileila; Siena, Salvatore

    2012-03-01

    Epidermal growth factor receptor (EGFR) gene copy number evaluated by fluorescence in situ hybridisation (FISH) can discriminate among KRAS wild-type patients those with better outcome to EGFR-targeted therapy in metastatic colorectal cancer, further enhancing selection of patients. Nevertheless, enumeration of gene copies is challenging and the lack of analytical standardisation has limited incorporation of the test into the clinical practice. We therefore assessed EGFR FISH interlaboratory consensus among five molecular diagnostic reference centres. A set of 12 colorectal cancer samples circulated among laboratories, and samples were scored according to commonly agreed guidelines. Reproducibility was quantified using the standard error of measurement (SEM). A SEM of 0.865 and a within-subject coefficient of variation (WSCV) of 26.8% for mean EGFR gene/nuclei and a SEM of 0.235 and a WSCV of 19.4% for the mean EGFR gene/CEP7 ratio were observed. Measurement of the fraction of cells displaying chromosome 7 polysomy showed WSCV of 46.6%, 34.0% and 51.0% for percentage of cells displaying ≤2, ≥3 and ≥4 EGFR signals, respectively. Among different slides of the same specimen, the WSCV was 6.1% for mean EGFR gene/nuclei and 3.9% for mean of EGFR gene/CEP7 ratios. Molecular diagnosis of EGFR gene copy number by FISH varied largely among pathology centres, with fluctuations covering the whole range of proposed cut-offs of predictive usefulness from literature. Definition of a detailed scoring system and implementation of comprehensive training programmes for laboratories are therefore necessary before including the test into clinical practice.

  18. Philosophers assess randomized clinical trials: the need for dialogue.

    Science.gov (United States)

    Miké, V

    1989-09-01

    In recent years a growing number of professional philosophers have joined in the controversy over ethical aspects of randomized clinical trials (RCTs). Morally questionable in their utilitarian approach, RCTs are claimed by some to be in direct violation of the second form of Kant's Categorical Imperative. But the arguments used in these critiques at times derive from a lack of insight into basic statistical procedures and the realities of the biomedical research process. Presented to physicians and other nonspecialists, including the lay public, such distortions can be harmful. Given the great complexity of statistical methodology and the anomalous nature of concepts of evidence, more sustained input into the interdisciplinary dialogue is needed from the statistical profession.

  19. Biochemical methane potential (BMP) of solid organic substrates: evaluation of anaerobic biodegradability using data from an international interlaboratory study

    NARCIS (Netherlands)

    Raposo, F.; Fernandez-Cegri, V.; Rubia, de la M.A.; Borja, R.; Beline, F.; Cavinato, C.; Demirer, G.; Fernandez, B.; Fernandez-Polanco, M.; Frigon, J.C.; Ganesh, R.; Kaparaju, P.; Koubova, J.; Mendez, R.; Menin, G.; Peene, A.; Scherer, P.; Torrijos, M.; Uellendahl, H.; Wierinck, I.; Wilde, de V.

    2011-01-01

    BACKGROUND: This paper describes results obtained for different participating research groups in an interlaboratory study related to biochemical methane potential (BMP). In this research work, all experimental conditions influencing the test such as inoculum, substrate characteristics and

  20. Assessing treatment outcomes in multiple sclerosis trials and in the clinical setting.

    Science.gov (United States)

    Tur, Carmen; Moccia, Marcello; Barkhof, Frederik; Chataway, Jeremy; Sastre-Garriga, Jaume; Thompson, Alan J; Ciccarelli, Olga

    2018-02-01

    Increasing numbers of drugs are being developed for the treatment of multiple sclerosis (MS). Measurement of relevant outcomes is key for assessing the efficacy of new drugs in clinical trials and for monitoring responses to disease-modifying drugs in individual patients. Most outcomes used in trial and clinical settings reflect either clinical or neuroimaging aspects of MS (such as relapse and accrual of disability or the presence of visible inflammation and brain tissue loss, respectively). However, most measures employed in clinical trials to assess treatment effects are not used in routine practice. In clinical trials, the appropriate choice of outcome measures is crucial because the results determine whether a drug is considered effective and therefore worthy of further development; in the clinic, outcome measures can guide treatment decisions, such as choosing a first-line disease-modifying drug or escalating to second-line treatment. This Review discusses clinical, neuroimaging and composite outcome measures for MS, including patient-reported outcome measures, used in both trials and the clinical setting. Its aim is to help clinicians and researchers navigate through the multiple options encountered when choosing an outcome measure. Barriers and limitations that need to be overcome to translate trial outcome measures into the clinical setting are also discussed.

  1. Interlaboratory validation data on real-time polymerase chain reaction detection for unauthorized genetically modified papaya line PRSV-YK

    Directory of Open Access Journals (Sweden)

    Kosuke Nakamura

    2016-06-01

    Real-time polymerase chain reaction (PCR detection method for unauthorized genetically modified (GM papaya (Carica papaya L. line PRSV-YK (PRSV-YK detection method was developed using whole genome sequence data (DDBJ Sequenced Read Archive under accession No. PRJDB3976. Interlaboratory validation datasets for PRSV-YK detection method were provided. Data indicating homogeneity of samples prepared for interlaboratory validation were included. Specificity and sensitivity test data for PRSV-YK detection method were also provided.

  2. Assessing noninferiority in a three-arm trial using the Bayesian approach.

    Science.gov (United States)

    Ghosh, Pulak; Nathoo, Farouk; Gönen, Mithat; Tiwari, Ram C

    2011-07-10

    Non-inferiority trials, which aim to demonstrate that a test product is not worse than a competitor by more than a pre-specified small amount, are of great importance to the pharmaceutical community. As a result, methodology for designing and analyzing such trials is required, and developing new methods for such analysis is an important area of statistical research. The three-arm trial consists of a placebo, a reference and an experimental treatment, and simultaneously tests the superiority of the reference over the placebo along with comparing this reference to an experimental treatment. In this paper, we consider the analysis of non-inferiority trials using Bayesian methods which incorporate both parametric as well as semi-parametric models. The resulting testing approach is both flexible and robust. The benefit of the proposed Bayesian methods is assessed via simulation, based on a study examining home-based blood pressure interventions. Copyright © 2011 John Wiley & Sons, Ltd.

  3. ASSESSMENT OF AMLODIPINE ANTIHYPERTENSIVE EFFECT HOMOGENEITY IN CONTROLLED TRIAL

    Directory of Open Access Journals (Sweden)

    V. M. Gorbunov

    2016-01-01

    Full Text Available Aim. To compare influence of amlodipine and spirapril on ambulatory blood pressure profile, including antihypertensive effect smoothness in patients with arterial hypertension (HT.Methods. 39 patients (aged 53,7±10,0 y.o. with HT were included in the open, randomized, cross-over study, 30 patients completed study. The duration of every therapies was 4 weeks, initial control period and wash-out period between therapies lasted 1 week. The initial daily dose of amlodipine was 5 mg, standard dose of spirapril (6 mg/daily was not changed during the trial. After 1-2 weeks of treatment amlodipine dose was increased up to 10 mg/daily as well as dihydrochlorothiazide was added, if necessary. Ambulatory blood pressure monitoring (ABPM was performed initially and at the end of both therapies.Results. Both drugs demonstrated good antihypertensive effect according to ABPM data. Decrease of systolic/diastolic blood pressure was 11,2±1,8/7,6±1,2 mm Hg in amlodipine therapy and 10,0±1,8/7,1±1,2 in spirapril therapy (p<0,0001. The smoothness indexes (SI were 0,65/0,45 and 0,55/0,45, respectively, differences between two therapies were not significant. However the individual analysis of the SI distribution (with SI=0,5 as a satisfactory criterion, showed that antihypertensive effect smoothness is better in amlodipine therapy than this in spirapril one.Conclusion. Amlodipine has prominent as well as smooth antihypertensive effect, that gives it advantages in the long-term antihypertensive therapy.

  4. ASSESSMENT OF AMLODIPINE ANTIHYPERTENSIVE EFFECT HOMOGENEITY IN CONTROLLED TRIAL

    Directory of Open Access Journals (Sweden)

    V. M. Gorbunov

    2009-01-01

    Full Text Available Aim. To compare influence of amlodipine and spirapril on ambulatory blood pressure profile, including antihypertensive effect smoothness in patients with arterial hypertension (HT.Methods. 39 patients (aged 53,7±10,0 y.o. with HT were included in the open, randomized, cross-over study, 30 patients completed study. The duration of every therapies was 4 weeks, initial control period and wash-out period between therapies lasted 1 week. The initial daily dose of amlodipine was 5 mg, standard dose of spirapril (6 mg/daily was not changed during the trial. After 1-2 weeks of treatment amlodipine dose was increased up to 10 mg/daily as well as dihydrochlorothiazide was added, if necessary. Ambulatory blood pressure monitoring (ABPM was performed initially and at the end of both therapies.Results. Both drugs demonstrated good antihypertensive effect according to ABPM data. Decrease of systolic/diastolic blood pressure was 11,2±1,8/7,6±1,2 mm Hg in amlodipine therapy and 10,0±1,8/7,1±1,2 in spirapril therapy (p<0,0001. The smoothness indexes (SI were 0,65/0,45 and 0,55/0,45, respectively, differences between two therapies were not significant. However the individual analysis of the SI distribution (with SI=0,5 as a satisfactory criterion, showed that antihypertensive effect smoothness is better in amlodipine therapy than this in spirapril one.Conclusion. Amlodipine has prominent as well as smooth antihypertensive effect, that gives it advantages in the long-term antihypertensive therapy.

  5. Assessment of adherence with oral anticancer agents in oncology clinical trials: A systematic review.

    Science.gov (United States)

    Bergsbaken, J J; Eickhoff, J C; Buss, B A; Mably, M S; Kolesar, J M

    2016-02-01

    Despite recommendations for adherence reporting in clinical trials involving an oral anticancer agent, the frequency and methods of adherence reporting are inconsistent. The purpose of this systematic review is to determine the frequency and type of adherence measures used in oncology and hematology clinical trials of oral anticancer agents and their association with study characteristics including quality, cancer type, stage and treatment type. PubMed was searched of all randomized controlled clinical trials assessing self-administered pharmacological interventions in patients with cancer and published over two years, between 1 January 2011 and 31 December 2012 were evaluated. We identified 70 publications in the PubMed database, comprising 45,118 total patients. Adherence reporting was present in 14 of 70 trials (20%); quantitative reporting was present in three of 70 trials (4%). Method of adherence assessment varied and included medication count, medication diaries and patient self-report. There was no association between adherence reporting and study quality or other study characteristics, although there was a trend towards increased reporting in breast cancer studies, with 46% of the studies reporting adherence (p = 0.0621). In a preliminary analysis, hematology studies (mean Jadad score 2.19 ± 1.47) were found to have significantly lower quality when compared to non-hematology trials (mean Jadad score 3.39 ± 1.37, p = 0.0034). This systematic review demonstrates adherence reporting in clinical trials of oral anticancer agents is infrequent. When reported, adherence was not associated with overall study quality or other study characteristics. Given the potential effects of non-adherence on study power and validity, adherence reporting should be encouraged in oncology and hematology clinical trials. © The Author(s) 2015.

  6. Unreported formal assessment of unblinding occurred in 4 of 10 randomized clinical trials, unreported loss of blinding in 1 of 10 trials

    DEFF Research Database (Denmark)

    Bello, Segun; Moustgaard, Helene; Hróbjartsson, Asbjørn

    2017-01-01

    Objectives Randomized clinical trials often involve blinding as a methodological procedure to avoid bias. Unfortunately, blinding procedures may be unsuccessful, but the risk of unblinding is rarely reported in trial publications. Our primary aim was to assess the occurrence of unreported assessm...

  7. Inter-laboratory comparison of X-ray fluorescence analyses of eruptive products of El Chichón Volcano, Chiapas, Mexico

    Science.gov (United States)

    Tilling, Robert I.; Bornhorst, Theodore J.; Taggart, Joseph E.; Rose, William I.; McGee, James J.

    1987-01-01

    An inter-laboratory comparison has been made of X-ray fluorescence analyses of 10 samples of lava and pumices from El Chichón Volcano, Chiapas, Mexico. Some determinations of major-element constituents agree within analytical uncertainty, whereas others exchibit significant bias. Analyses carried out at the Michigan Technological University (MTU) laboratory are systematically lower in MgO (26–48%), Fetotal(5–18%), CaO (4–15%) and higher in K2O (0–15%) than analyses made at the U.S. Geological Survey (USGS) Denver laboratory. These differences are ascribed in part to a complex combination of calibration assumptionsand mineralogical and particle-size effects inherent in the use of pressed rock-powder pellets in the analytical procedure of the MTU laboratory. Other, but as yet unknown, differences in sample preparation and/or analytical technique may also be important; effects related to natural sample inhomogeneityare believed to be insignificant. The inter-laboratory differences in the analytical data complicated accurate assessment of whether El Chichón magmas have changed composition during the past 300 000 a. Knowledge of such change is needed for understanding petrogenetic history and for such related studies as evaluation of volcanic hazards.

  8. Results of the Interlaboratory Exercise CSN/CIEMAT-100 Among Environmental Radioactivity Laboratories (Soil); Resultados del Ejercicio Interlaboratorios de Radiactividad Ambiental CSN/CIEMAT-00 (Suelo)

    Energy Technology Data Exchange (ETDEWEB)

    Romero Gonzalez, M. L.

    2002-07-01

    The document describes the outcome of the CSN/CIEMAT-00 interlaboratory test comparison among environmental radioactivity laboratories. the exercise was organised according to the ISO-43 and the ISO/IUPAC/AOAC Harmonized Protocol for the proficiency testing of analytical laboratories. the test sample was a soil containing environmental levels of K-40, Ra-226, Ac-228, Sr-90, Cs-137, Cs-134, Pu (239-240) y Am-241. the Universidad Autonoma de Barcelona prepared the material and reported adequate statistical studies of homogeneity. The results of the exercise were computed for 30 participating laboratories, and their analytical performance was assessed using the u-score approach. A raised percentage of satisfactory laboratory performance has been obtained for all the analysis, being the best performance in gamma measurements. The exercise has drawn that several laboratories have difficulties in the evaluation of combined uncertainty, mainly in analysis involving radiochemical steps. The study has shown an homogeneous inter-laboratory behaviour, and the improvement achieved through subsequent exercises in the quality of the data they are producing. (Author) 10 refs.

  9. Orientation and mobility assessment in retinal prosthetic clinical trials.

    Science.gov (United States)

    Geruschat, Duane R; Bittner, Ava K; Dagnelie, Gislin

    2012-09-01

    The purpose of this study was to develop an orientation and mobility (O&M) assessment protocol to implement in subjects who have been implanted with an artificial silicon retina (ASR), and to use this experience to propose a research agenda for O&M with prosthetic vision. A controlled and naturalistic assessment was developed that included walking a prescribed obstacle course and travel to and from a hospital cafeteria. Subjects were tested before and 3 and 6 months after being implanted with the ASR. Outcome measures were walking speed and number of contacts with obstacles. The experiences from this study led to a proposed research agenda in O&M. Eight subjects with retinitis pigmentosa participated in this study. The vision status of the subjects ranged from mobility after implantation. Three subjects self-reported enhancements of travel after implantation, but this enhancement was not observed. This study demonstrates that mobility might not be improved with prosthetic vision. The proposed research agenda emphasizes the importance of developing individualized assessments, identifying specific items of orientation rather than mobility for measuring the effect of prosthetic vision, and to develop and evaluate instructional programs that may be needed to obtain the full benefit of the technology.

  10. Quality of reporting in oncology phase II trials: A 5-year assessment through systematic review.

    Science.gov (United States)

    Langrand-Escure, Julien; Rivoirard, Romain; Oriol, Mathieu; Tinquaut, Fabien; Rancoule, Chloé; Chauvin, Frank; Magné, Nicolas; Bourmaud, Aurélie

    2017-01-01

    Phase II clinical trials are a cornerstone of the development in experimental treatments They work as a "filter" for phase III trials confirmation. Surprisingly the attrition ratio in Phase III trials in oncology is significantly higher than in any other medical specialty. This suggests phase II trials in oncology fail to achieve their goal. Objective The present study aims at estimating the quality of reporting in published oncology phase II clinical trials. A literature review was conducted among all phase II and phase II/III clinical trials published during a 5-year period (2010-2015). All articles electronically published by three randomly-selected oncology journals with Impact-Factors>4 were included: Journal of Clinical Oncology, Annals of Oncology and British Journal of Cancer. Quality of reporting was assessed using the Key Methodological Score. 557 articles were included. 315 trials were single-arm studies (56.6%), 193 (34.6%) were randomized and 49 (8.8%) were non-randomized multiple-arm studies. The Methodological Score was equal to 0 (lowest level), 1, 2, 3 (highest level) respectively for 22 (3.9%), 119 (21.4%), 270 (48.5%) and 146 (26.2%) articles. The primary end point is almost systematically reported (90.5%), while sample size calculation is missing in 66% of the articles. 3 variables were independently associated with reporting of a high standard: presence of statistical design (p-value <0.001), multicenter trial (p-value = 0.012), per-protocol analysis (p-value <0.001). Screening was mainly performed by a sole author. The Key Methodological Score was based on only 3 items, making grey zones difficult to translate. This literature review highlights the existence of gaps concerning the quality of reporting. It therefore raised the question of the suitability of the methodology as well as the quality of these trials, reporting being incomplete in the corresponding articles.

  11. Methodical principles of assessment of financial compensation for clinical trial volunteer participants

    Directory of Open Access Journals (Sweden)

    V. Ye. Dobrova

    2013-10-01

    participation in clinical trials by patients and healthy volunteers has been rationalized, whereas methods of calculating monetary compensation for such participation have been suggested. The two methods of calculating of the financial compensation were proposed: first - hourly compensation for the time which was spent on clinical trials, the second - hourly-bonus compensation for the possible discomfort and inconvenience of participation in clinical trials in accordance with the ethical rules for research involving people as objects of observation. Conclusion. Achievement of the organizational and financial constituent ensuring participation of volunteers in a clinical trial on the one hand should assure the appropriate experimental foundation for reliable research conducting and on other hand should focus attention on the fulfillment of mental and ethical rules for investigations involving human as a studied object. Basing on the results of an analysis and the survey performed which involved qualified experts regarding aspects affecting volunteers enrollment in a clinical trial, the scientifically substantiated system of the volunteers discomfort and inconvenience assessment in a clinical trial has been proposed, which includes criteria: study duration, adverse events/adverse reactions possibility, blood sampling during study, discomfort caused by study design, inconvenience to participate in a clinical trial. Two techniques for calculation of the financial compensation for healthy volunteers participation in a clinical trial have been proposed: the first one is the payment by the hour spent for participation in a study, and the second one is the hourly pay with bonus for possible discomfort caused by involvement in a clinical trial. In the further study authors plan to research the aspects of risk assessment associated with volunteers participation in a clinical trial and its considering as an additional constituent in the process of the calculation of financial incentives

  12. Student Experience of Oral Communication Assessment Tasks Online from a Multi-Disciplinary Trial

    Science.gov (United States)

    McBain, Bonnie; Drew, Antony; James, Carole; Phelan, Liam; Harris, Keith M; Archer, Jennifer

    2016-01-01

    Purpose: The purpose of this paper is to evaluate the experiences of tertiary students learning oral presentation skills in a range of online and blended learning contexts across diverse disciplines. Design/methodology/approach: The research was designed as a "federation" of trials of diverse online oral communications assessment tasks…

  13. An assessment of the quality of randomised controlled trials conducted in China

    Directory of Open Access Journals (Sweden)

    Zhong Nanshan

    2008-04-01

    Full Text Available Abstract Background Despite the rapid increase in research in China, little is known about the quality of clinical trials conducted there. Methods A systematic review and critical appraisal of randomised controlled trials (RCTs conducted in China and published in 2004 was undertaken to describe their characteristics, assess the quality of their reporting, and where possible, the quality of their conduct. Randomised controlled trials in all disease areas and types of interventions, which took place in China and included Chinese citizens were identified using PubMed and hand searching the Journal Series of the Chinese Medical Association. Quality was assessed against a subset of criteria adapted from the CONSORT statement. Results Three hundred and seven RCTs were included. One hundred and ninety-nine (64.8% failed to report methods of randomization and 254 (82.4% did not mention blinding of either participants or investigators. Reporting of baseline characteristics, primary outcome and length of follow-up was inadequate in a substantial proportion of studies. Fewer than 11% of RCTs mentioned ethical approval and only 18.0% adequately discussed informed consent. However, dropout rates were very favourable with nearly 44% of trials reporting a zero dropout rate. Conclusion Reporting of RCTs in China requires substantial improvement to meet the targets of the CONSORT statement. The conduct of Chinese RCTs cannot be directly inferred from the standard of reporting; however without good reporting the methods of the trials cannot be clearly ascertained.

  14. Interlaboratory study of precision: Hyalella azteca and Chironomus tentans freshwater sediment toxicity assays

    Science.gov (United States)

    Burton, G.A.; Norberg-King, T. J.; Ingersoll, C.G.; Benoit, D.A.; Ankley, G.T.; Winger, P.V.; Kubitz, J.; Lazorchak, J.M.; Smith, M.E.; Greer, E.; Dwyer, F.J.; Call, D.J.; Day, K.E.; Kennedy, P.; Stinson, M.

    1996-01-01

    Standard 10-d whole-sediment toxicity test methods have recently been developed by the U.S. Environmental Protection Agency (EPA) for the amphipod Hyalella azteca and the midge Chironomus tentans. An interlaboratory evaluation of method precision was performed using a group of seven to 10 laboratories, representing government, academia, and environmental consulting firms. The test methods followed the EPA protocols for 4-d water-only reference toxicant (KCl) testing (static exposure) and for 10-d whole-sediment testing. Test sediments included control sediment, two copper-containing sediments, and a sediment contaminated primarily with polycyclic aromatic hydrocarbons. Reference toxicant tests resulted in H. azteca and C. tentans median lethal concentration (LC50) values with coefficents of variation (CVs) of 15.8 and 19.6%, respectively. Whole sediments which were moderately contaminated provided the best estimates of precision using CVs. Hyalella azteca and C. tentans tests in moderately contaminated sediments exhibited LC50 CVs of 38.9 and 13.5%, respectively. The CV for C. tentans growth was 31.9%. Only 3% (1 of 28) of samples exceeded acceptable interlaboratory precision limits for the H. azteca survival tests. No samples exceeded the intralaboratory precision limit for H. azteca or C. tentans survival tests. However, intralaboratory variability limits for C. tentans growth were exceeded by 80 and 100% of the laboratories for a moderately toxic and control sample, respectively. Interlaboratory variability limits for C. tentans survival were not exceeded by any laboratory. The results showed these test methods to have relatively low variance and acceptable levels of precision in interlaboratory comparisons.

  15. Les essais inter-laboratoires en microbiologie des aliments Inter-laboratory studies in food microbiology

    OpenAIRE

    Lombard, Bertrand

    2004-01-01

    The validity of microbiological controls, performed for ensuring food safety, requires in particular reliable analytical results. Such reliability needs validated methods, implemented by a competent laboratory. The inter-laboratory studies enable to respect, at least partly, these two conditions. Meanwhile, given experimental limitations, these studies are not so largely performed in food microbiology than in other analytical fields. In a first step, a review of reference documents enables to...

  16. Cardiovascular risk assessment in the treatment of nonalcoholic steatohepatitis: a secondary analysis of the MOZART trial.

    Science.gov (United States)

    Lin, Steven C; Ang, Brandon; Hernandez, Carolyn; Bettencourt, Ricki; Jain, Rashmi; Salotti, Joanie; Richards, Lisa; Kono, Yuko; Bhatt, Archana; Aryafar, Hamed; Lin, Grace Y; Valasek, Mark A; Sirlin, Claude B; Brouha, Sharon; Loomba, Rohit

    2016-03-01

    Nonalcoholic steatohepatitis (NASH) is associated with increased cardiovascular risk and mortality. No US Food and Drug Administration (FDA) approved therapies for NASH are available; clinical trials to date have not yet systematically assessed for changes in cardiovascular risk. This study examines the prospective utility of cardiovascular risk assessments, the Framingham risk score (FRS) and coronary artery calcium (CAC) score, as endpoints in a NASH randomized clinical trial, and assesses whether histologic improvements lead to lower cardiovascular risk. Secondary analysis of a 24-week randomized, double-blind, placebo-controlled trial (MOZART) in which 50 biopsy-proven NASH patients received oral ezetimibe 10 mg daily (n = 25) versus placebo (n = 25). Biochemical profiling, FRS, CAC scores, liver biopsies were obtained at baseline and endpoint. Ezetimibe improved FRS whereas placebo did not (4.4 ± 6.2 to 2.9 ± 4.8, p = 0.038; 3.0 ± 4.4 to 2.9 ± 4.2, p = 0.794). CAC scores did not change with ezetimibe or placebo (180.4 ± 577.2 to 194.1 ± 623.9, p = 0.293; 151.4 ± 448.9 to 183.3 ± 555.7, p = 0.256). Ezetimibe improved FRS and CAC scores in more patients than placebo (48% versus 23%, p = 0.079, and 21% versus 0%, p = 0.090, respectively), though not significantly. No differences were noted in cardiovascular risk scores among histologic responders versus nonresponders. Ezetimibe improved FRS whereas placebo did not. FRS and CAC scores improved in a greater proportion of patients with ezetimibe; this trend did not reach significance. These findings indicate the utility and feasibility of monitoring cardiovascular risk in a NASH trial. The utility of CAC scores may be higher in trials of longer duration (⩾52 weeks) and with older patients (age ⩾45). ClinicalTrials.gov registration: NCT01766713.

  17. Geographic Information Systems to Assess External Validity in Randomized Trials.

    Science.gov (United States)

    Savoca, Margaret R; Ludwig, David A; Jones, Stedman T; Jason Clodfelter, K; Sloop, Joseph B; Bollhalter, Linda Y; Bertoni, Alain G

    2017-08-01

    To support claims that RCTs can reduce health disparities (i.e., are translational), it is imperative that methodologies exist to evaluate the tenability of external validity in RCTs when probabilistic sampling of participants is not employed. Typically, attempts at establishing post hoc external validity are limited to a few comparisons across convenience variables, which must be available in both sample and population. A Type 2 diabetes RCT was used as an example of a method that uses a geographic information system to assess external validity in the absence of a priori probabilistic community-wide diabetes risk sampling strategy. A geographic information system, 2009-2013 county death certificate records, and 2013-2014 electronic medical records were used to identify community-wide diabetes prevalence. Color-coded diabetes density maps provided visual representation of these densities. Chi-square goodness of fit statistic/analysis tested the degree to which distribution of RCT participants varied across density classes compared to what would be expected, given simple random sampling of the county population. Analyses were conducted in 2016. Diabetes prevalence areas as represented by death certificate and electronic medical records were distributed similarly. The simple random sample model was not a good fit for death certificate record (chi-square, 17.63; p=0.0001) and electronic medical record data (chi-square, 28.92; p<0.0001). Generally, RCT participants were oversampled in high-diabetes density areas. Location is a highly reliable "principal variable" associated with health disparities. It serves as a directly measurable proxy for high-risk underserved communities, thus offering an effective and practical approach for examining external validity of RCTs. Copyright © 2017 American Journal of Preventive Medicine. Published by Elsevier Inc. All rights reserved.

  18. Retrospective radiation dosimetry using OSL of electronic components: Results of an inter-laboratory comparison

    International Nuclear Information System (INIS)

    Bassinet, C.; Woda, C.; Bortolin, E.; Della Monaca, S.; Fattibene, P.; Quattrini, M.C.; Bulanek, B.; Ekendahl, D.; Burbidge, C.I.; Cauwels, V.; Kouroukla, E.; Geber-Bergstrand, T.; Mrozik, A.; Marczewska, B.; Bilski, P.; Sholom, S.; McKeever, S.W.S.; Smith, R.W.; Veronese, I.

    2014-01-01

    In the framework of the EU-FP7 MULTIBIODOSE project, two protocols using OSL of resistors removed from the circuit board of mobile phones were developed with the aim to use the resistors as fortuitous dosimeters in the event of a large scale radiological accident. This paper presents the results of an inter-laboratory comparison carried out under the umbrella of EURADOS. The two aims of this exercise were the validation of the MULTIBIODOSE protocols by a large number of laboratories and the dissemination of the method with the objective of preparing the basis for a network that could increase Europe's response capacity in the case of a mass casualty radiological emergency. Twelve institutes from eleven European countries and one institute from the USA, with various degrees of expertise in OSL dosimetry, took part in the OSL inter-laboratory comparison. Generally, a good agreement within uncertainties was observed between estimated and nominal doses. - Highlights: • Resistors in mobile phones could function as reliable fortuitous dosimeters in case of a large scale radiological accident. • Two OSL protocols were validated by an inter-laboratory comparison. • It is feasible to set up a network of laboratories so as to increase the measurement capacity

  19. Intra- and interlaboratory variability in acute toxicity tests with glochidia and juveniles of freshwater mussels (Unionidae)

    Science.gov (United States)

    Wang, N.; Augspurger, T.; Barnhart, M.C.; Bidwell, Joseph R.; Cope, W.G.; Dwyer, F.J.; Geis, S.; Greer, I.E.; Ingersoll, C.G.; Kane, C.M.; May, T.W.; Neves, R.J.; Newton, T.J.; Roberts, A.D.; Whites, D.W.

    2007-01-01

    The present study evaluated the performance and variability in acute toxicity tests with glochidia and newly transformed juvenile mussels using the standard methods outlined in American Society for Testing and Materials (ASTM). Multiple 48-h toxicity tests with glochidia and 96-h tests with juvenile mussels were conducted within a single laboratory and among five laboratories. All tests met the test acceptability requirements (e.g., ???90% control survival). Intralaboratory tests were conducted over two consecutive mussel-spawning seasons with mucket (Actinonaias ligamentina) or fatmucket (Lampsilis siliquoidea) using copper, ammonia, or chlorine as a toxicant. For the glochidia of both species, the variability of intralaboratory median effective concentrations (EC50s) for the three toxicants, expressed as the coefficient of variation (CV), ranged from 14 to 27% in 24-h exposures and from 13 to 36% in 48-h exposures. The intralaboratory CV of copper EC50s for juvenile fatmucket was 24% in 48-h exposures and 13% in 96-h exposures. Interlaboratory tests were conducted with fatmucket glochidia and juveniles by five laboratories using copper as a toxicant. The interlaboratory CV of copper EC50s for glochidia was 13% in 24-h exposures and 24% in 48-h exposures, and the interlaboratory CV for juveniles was 22% in 48-h exposures and 42% in 96-h exposures. The high completion success and the overall low variability in test results indicate that the test methods have acceptable precision and can be performed routinely. ?? 2007 SETAC.

  20. Interlaboratory comparison of real-time pcr protocols for quantification of general fecal indicator bacteria

    Science.gov (United States)

    Shanks, O.C.; Sivaganesan, M.; Peed, L.; Kelty, C.A.; Blackwood, A.D.; Greene, M.R.; Noble, R.T.; Bushon, R.N.; Stelzer, E.A.; Kinzelman, J.; Anan'Eva, T.; Sinigalliano, C.; Wanless, D.; Griffith, J.; Cao, Y.; Weisberg, S.; Harwood, V.J.; Staley, C.; Oshima, K.H.; Varma, M.; Haugland, R.A.

    2012-01-01

    The application of quantitative real-time PCR (qPCR) technologies for the rapid identification of fecal bacteria in environmental waters is being considered for use as a national water quality metric in the United States. The transition from research tool to a standardized protocol requires information on the reproducibility and sources of variation associated with qPCR methodology across laboratories. This study examines interlaboratory variability in the measurement of enterococci and Bacteroidales concentrations from standardized, spiked, and environmental sources of DNA using the Entero1a and GenBac3 qPCR methods, respectively. Comparisons are based on data generated from eight different research facilities. Special attention was placed on the influence of the DNA isolation step and effect of simplex and multiplex amplification approaches on interlaboratory variability. Results suggest that a crude lysate is sufficient for DNA isolation unless environmental samples contain substances that can inhibit qPCR amplification. No appreciable difference was observed between simplex and multiplex amplification approaches. Overall, interlaboratory variability levels remained low (<10% coefficient of variation) regardless of qPCR protocol. ?? 2011 American Chemical Society.

  1. Developing dementia prevention trials: baseline report of the Home-Based Assessment study.

    Science.gov (United States)

    Sano, Mary; Egelko, Susan; Donohue, Michael; Ferris, Steven; Kaye, Jeffrey; Hayes, Tamara L; Mundt, James C; Sun, Chung-Kai; Paparello, Silvia; Aisen, Paul S

    2013-01-01

    This report describes the baseline experience of the multicenter, Home-Based Assessment study, designed to develop methods for dementia prevention trials using novel technologies for test administration and data collection. Nondemented individuals of 75 years of age or more were recruited and evaluated in-person using established clinical trial outcomes of cognition and function, and randomized to one of 3 assessment methodologies: (1) mail-in questionnaire/live telephone interviews [mail-in/phone (MIP)]; (2) automated telephone with interactive voice recognition; and (3) internet-based computer Kiosk. Brief versions of cognitive and noncognitive outcomes were adapted to each methodology and administered at baseline and repeatedly over a 4-year period. "Efficiency" measures assessed the time from screening to baseline, and staff time required for each methodology. A total of 713 individuals signed consent and were screened; 640 met eligibility and were randomized to one of 3 assessment arms; and 581 completed baseline. Dropout, time from screening to baseline, and total staff time were highest among those assigned to internet-based computer Kiosk. However, efficiency measures were driven by nonrecurring start-up activities suggesting that differences may be mitigated over a long trial. Performance among Home-Based Assessment instruments collected through different technologies will be compared with established outcomes over this 4-year study.

  2. Developing an OMERACT Core Outcome Set for Assessing Safety Components in Rheumatology Trials

    DEFF Research Database (Denmark)

    Klokker, Louise; Tugwell, Peter; Furst, Daniel E

    2016-01-01

    in such COS. The Outcome Measures in Rheumatology (OMERACT) Filter 2.0 emphasizes the importance of measuring harms. The Safety Working Group was reestablished at the OMERACT 2016 with the objective to develop a COS for assessing safety components in trials across rheumatologic conditions. METHODS: The safety......OBJECTIVE: Failure to report harmful outcomes in clinical research can introduce bias favoring a potentially harmful intervention. While core outcome sets (COS) are available for benefits in randomized controlled trials in many rheumatic conditions, less attention has been paid to safety...... components of safety that should be measured in such trials by use of a patient-driven approach including qualitative data collection and statistical organization of data, and (3) developing a COS through consensus processes including everyone involved. RESULTS: Members of OMERACT including patients...

  3. How many research nurses for how many clinical trials in an oncology setting? Definition of the Nursing Time Required by Clinical Trial-Assessment Tool (NTRCT-AT).

    Science.gov (United States)

    Milani, Alessandra; Mazzocco, Ketti; Stucchi, Sara; Magon, Giorgio; Pravettoni, Gabriella; Passoni, Claudia; Ciccarelli, Chiara; Tonali, Alessandra; Profeta, Teresa; Saiani, Luisa

    2017-02-01

    Few resources are available to quantify clinical trial-associated workload, needed to guide staffing and budgetary planning. The aim of the study is to describe a tool to measure clinical trials nurses' workload expressed in time spent to complete core activities. Clinical trials nurses drew up a list of nursing core activities, integrating results from literature searches with personal experience. The final 30 core activities were timed for each research nurse by an outside observer during daily practice in May and June 2014. Average times spent by nurses for each activity were calculated. The "Nursing Time Required by Clinical Trial-Assessment Tool" was created as an electronic sheet that combines the average times per specified activities and mathematic functions to return the total estimated time required by a research nurse for each specific trial. The tool was tested retrospectively on 141 clinical trials. The increasing complexity of clinical research requires structured approaches to determine workforce requirements. This study provides a tool to describe the activities of a clinical trials nurse and to estimate the associated time required to deliver individual trials. The application of the proposed tool in clinical research practice could provide a consistent structure for clinical trials nursing workload estimation internationally. © 2016 John Wiley & Sons Australia, Ltd.

  4. O papel dos programas interlaboratoriais para a qualidade dos resultados analíticos Interlaboratorial programs for improving the quality of analytical results

    Directory of Open Access Journals (Sweden)

    Queenie Siu Hang Chui

    2004-12-01

    Full Text Available Interlaboratorial programs are conducted for a number of purposes: to identify problems related to the calibration of instruments, to assess the degree of equivalence of analytical results among several laboratories, to attribute quantity values and its uncertainties in the development of a certified reference material and to verify the performance of laboratories as in proficiency testing, a key quality assurance technique, which is sometimes used in conjunction with accreditation. Several statistics tools are employed to assess the analytical results of laboratories participating in an intercomparison program. Among them are the z-score technique, the elypse of confidence and the Grubbs and Cochran test. This work presents the experience in coordinating an intercomparison exercise in order to determine Ca, Al, Fe, Ti and Mn, as impurities in samples of silicon metal of chemical grade prepared as a candidate for reference material.

  5. Linking quantitative microbial risk assessment and epidemiological data: informing safe drinking water trials in developing countries.

    Science.gov (United States)

    Enger, Kyle S; Nelson, Kara L; Clasen, Thomas; Rose, Joan B; Eisenberg, Joseph N S

    2012-05-01

    Intervention trials are used extensively to assess household water treatment (HWT) device efficacy against diarrheal disease in developing countries. Using these data for policy, however, requires addressing issues of generalizability (relevance of one trial in other contexts) and systematic bias associated with design and conduct of a study. To illustrate how quantitative microbial risk assessment (QMRA) can address water safety and health issues, we analyzed a published randomized controlled trial (RCT) of the LifeStraw Family Filter in the Congo. The model accounted for bias due to (1) incomplete compliance with filtration, (2) unexpected antimicrobial activity by the placebo device, and (3) incomplete recall of diarrheal disease. Effectiveness was measured using the longitudinal prevalence ratio (LPR) of reported diarrhea. The Congo RCT observed an LPR of 0.84 (95% CI: 0.61, 1.14). Our model predicted LPRs, assuming a perfect placebo, ranging from 0.50 (2.5-97.5 percentile: 0.33, 0.77) to 0.86 (2.5-97.5 percentile: 0.68, 1.09) for high (but not perfect) and low (but not zero) compliance, respectively. The calibration step provided estimates of the concentrations of three pathogen types (modeled as diarrheagenic E. coli, Giardia, and rotavirus) in drinking water, consistent with the longitudinal prevalence of reported diarrhea measured in the trial, and constrained by epidemiological data from the trial. Use of a QMRA model demonstrated the importance of compliance in HWT efficacy, the need for pathogen data from source waters, the effect of quantifying biases associated with epidemiological data, and the usefulness of generalizing the effectiveness of HWT trials to other contexts. © 2012 American Chemical Society

  6. Using objective markers to assess participant behavior in HIV prevention trials of vaginal microbicides.

    Science.gov (United States)

    Mauck, Christine K; Straten, Ariane van der

    2008-09-01

    The need to verify participant behavior exists in any study in which behavior may affect outcomes. In vaginal microbicide trials, the act of having sex and the use of study products and condoms all affect the risk of acquiring HIV/sexually transmitted infections (STIs). Until now, these behaviors have been assessed using self-reports. But self-reports are limited by participant cooperation in answering questions, imperfect recall, and social desirability biases. Biomarkers are increasingly being used in medicine to reduce the time and resources needed to bring a drug to market. The use of biomarkers in vaginal microbicide trials has been proposed as a means of assessing factors that affect the risk of sexual acquisition of HIV/STIs, namely, the presence of preexisting infection, cervicovaginal inflammation, and the presence of HIV/STIs. Biomarkers for some of these already exist. What are needed are validated markers of behaviors that might affect risk, namely, markers for sexual behavior and for the use of study products and condoms. Validating and working out the logistics of collecting such markers in large trials will be a challenge. But finding objective markers for behavior may help improve adherence measurement during a trial and is a rate-limiting step in the field of vaginal microbicides. Resources and funding should be mobilized to develop and validate markers of sexual behavior and product use as a high priority in vaginal microbicide research.

  7. Inter-laboratory verification of European pharmacopoeia monograph on derivative spectrophotometry method and its application for chitosan hydrochloride.

    Science.gov (United States)

    Marković, Bojan; Ignjatović, Janko; Vujadinović, Mirjana; Savić, Vedrana; Vladimirov, Sote; Karljiković-Rajić, Katarina

    2015-01-01

    Inter-laboratory verification of European pharmacopoeia (EP) monograph on derivative spectrophotometry (DS) method and its application for chitosan hydrochloride was carried out on two generation of instruments (earlier GBC Cintra 20 and current technology TS Evolution 300). Instruments operate with different versions of Savitzky-Golay algorithm and modes of generating digital derivative spectra. For resolution power parameter, defined as the amplitude ratio A/B in DS method EP monograph, comparable results were obtained only with algorithm's parameters smoothing points (SP) 7 and the 2nd degree polynomial and those provided corresponding data with other two modes on TS Evolution 300 Medium digital indirect and Medium digital direct. Using quoted algorithm's parameters, the differences in percentages between the amplitude ratio A/B averages, were within accepted criteria (±3%) for assay of drug product for method transfer. The deviation of 1.76% for the degree of deacetylation assessment of chitosan hydrochloride, determined on two instruments, (amplitude (1)D202; the 2nd degree polynomial and SP 9 in Savitzky-Golay algorithm), was acceptable, since it was within allowed criteria (±2%) for assay deviation of drug substance, for method transfer in pharmaceutical analyses. Copyright © 2015 Elsevier B.V. All rights reserved.

  8. Construction of measurement uncertainty profiles for quantitative analysis of genetically modified organisms based on interlaboratory validation data.

    Science.gov (United States)

    Macarthur, Roy; Feinberg, Max; Bertheau, Yves

    2010-01-01

    A method is presented for estimating the size of uncertainty associated with the measurement of products derived from genetically modified organisms (GMOs). The method is based on the uncertainty profile, which is an extension, for the estimation of uncertainty, of a recent graphical statistical tool called an accuracy profile that was developed for the validation of quantitative analytical methods. The application of uncertainty profiles as an aid to decision making and assessment of fitness for purpose is also presented. Results of the measurement of the quantity of GMOs in flour by PCR-based methods collected through a number of interlaboratory studies followed the log-normal distribution. Uncertainty profiles built using the results generally give an expected range for measurement results of 50-200% of reference concentrations for materials that contain at least 1% GMO. This range is consistent with European Network of GM Laboratories and the European Union (EU) Community Reference Laboratory validation criteria and can be used as a fitness for purpose criterion for measurement methods. The effect on the enforcement of EU labeling regulations is that, in general, an individual analytical result needs to be 1.8% to demonstrate noncompliance with a labeling threshold of 0.9%.

  9. Multivariable modelling for meta-epidemiological assessment of the association between trial quality and treatment effects estimated in randomized clinical trials

    DEFF Research Database (Denmark)

    Siersma, V; Als-Nielsen, B; Chen, Weikeng

    2007-01-01

    Methodological deficiencies are known to affect the results of randomized trials. There are several components of trial quality, which, when inadequately attended to, may bias the treatment effect under study. The extent of this bias, so far only vaguely known, is currently being investigated....... Therefore, a stable multivariable method that allows for heterogeneity is needed for assessing the 'bias coefficients'. We present two general statistical models for analysis of a study of 523 randomized trials from 48 meta-analyses in a random sample of Cochrane reviews: a logistic regression model uses...

  10. Very large treatment effects in randomised trials as an empirical marker to indicate whether subsequent trials are necessary: meta-epidemiological assessment.

    Science.gov (United States)

    Nagendran, Myura; Pereira, Tiago V; Kiew, Grace; Altman, Douglas G; Maruthappu, Mahiben; Ioannidis, John P A; McCulloch, Peter

    2016-10-27

     To examine whether a very large effect (VLE; defined as a relative risk of ≤0.2 or ≥5) in a randomised trial could be an empirical marker that subsequent trials are unnecessary.  Meta-epidemiological assessment of existing published data on randomised trials.  Cochrane Database of Systematic Reviews (2010, issue 7) with data on subsequent large trials updated to 2015, issue 12.  All binary outcome forest plots were selected, which contained an index randomised trial with a VLE that was nominally statistically significant (Pdata failed to find a statistically significant (Pdata found a statistically significant effect in the same direction in 19 of 21 cases when the index trial also had a value of PVLE in a randomised controlled trial as a marker that further trials are unnecessary would be neither practical nor useful. Caution should be taken when interpreting small studies with very large treatment effects. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://group.bmj.com/group/rights-licensing/permissions.

  11. Hepatitis C - Assessment to Treatment Trial (HepCATT) in primary care: study protocol for a cluster randomised controlled trial.

    Science.gov (United States)

    Roberts, Kirsty; Macleod, John; Metcalfe, Chris; Simon, Joanne; Horwood, Jeremy; Hollingworth, William; Marlowe, Sharon; Gordon, Fiona H; Muir, Peter; Coleman, Barbara; Vickerman, Peter; Harrison, Graham I; Waldron, Cherry-Ann; Irving, William; Hickman, Matthew

    2016-07-29

    Public Health England (PHE) estimates that there are upwards of 160,000 individuals in England and Wales with chronic hepatitis C virus (HCV) infection, but until now only around 100,000 laboratory diagnoses have been reported to PHE and of these 28,000 have been treated. Targeted case-finding in primary care is estimated to be cost-effective; however, there has been no robust randomised controlled trial evidence available of specific interventions. Therefore, this study aims to develop and conduct a complex intervention within primary care and to evaluate this approach using a cluster randomised controlled trial. A total of 46 general practices in South West England will be randomised in a 1:1 ratio to receive either a complex intervention comprising: educational training on HCV for the practice; poster and leaflet display in the practice waiting rooms to raise awareness and encourage opportunistic testing; a HCV risk prediction algorithm based on information on possible risk markers in the electronic patient record run using Audit + software (BMJ Informatica). The audit will then be used to recall and offer patients a HCV test. Control practices will follow usual care. The effectiveness of the intervention will be measured by comparing number and rates of HCV testing, the number and proportion of patients testing positive, onward referral, rates of specialist assessment and treatment in control and intervention practices. Intervention costs and health service utilisation will be recorded to estimate the NHS cost per new HCV diagnosis and new HCV patient initiating treatment. Longer-term cost-effectiveness of the intervention in improving quality-adjusted life years (QALYs) will be extrapolated using a pre-existing dynamic health economic model. Patients' and health care workers' experiences and acceptability of the intervention will be explored through semi-structured qualitative interviews. This trial has the potential to make an important impact on patient

  12. Robustness assessments are needed to reduce bias in meta-analyses that include zero-event randomized trials

    DEFF Research Database (Denmark)

    Keus, F; Wetterslev, J; Gluud, C

    2009-01-01

    of statistical method on inference. RESULTS: In seven meta-analyses of seven outcomes from 15 trials, there were zero-event trials in 0 to 71.4% of the trials. We found inconsistency in significance in one of seven outcomes (14%; 95% confidence limit 0.4%-57.9%). There was also considerable variability...... in the confidence limits, the intervention-effect estimates, and heterogeneity for all outcomes. CONCLUSIONS: The statistical method may influence the inference drawn from a meta-analysis that includes zero-event trials. Robustness assessments are needed to reduce bias in meta-analyses that include zero......OBJECTIVES: Meta-analysis of randomized trials with binary data can use a variety of statistical methods. Zero-event trials may create analytic problems. We explored how different methods may impact inferences from meta-analyses containing zero-event trials. METHODS: Five levels of statistical...

  13. Identifying items to assess methodological quality in physical therapy trials: a factor analysis.

    Science.gov (United States)

    Armijo-Olivo, Susan; Cummings, Greta G; Fuentes, Jorge; Saltaji, Humam; Ha, Christine; Chisholm, Annabritt; Pasichnyk, Dion; Rogers, Todd

    2014-09-01

    Numerous tools and individual items have been proposed to assess the methodological quality of randomized controlled trials (RCTs). The frequency of use of these items varies according to health area, which suggests a lack of agreement regarding their relevance to trial quality or risk of bias. The objectives of this study were: (1) to identify the underlying component structure of items and (2) to determine relevant items to evaluate the quality and risk of bias of trials in physical therapy by using an exploratory factor analysis (EFA). A methodological research design was used, and an EFA was performed. Randomized controlled trials used for this study were randomly selected from searches of the Cochrane Database of Systematic Reviews. Two reviewers used 45 items gathered from 7 different quality tools to assess the methodological quality of the RCTs. An exploratory factor analysis was conducted using the principal axis factoring (PAF) method followed by varimax rotation. Principal axis factoring identified 34 items loaded on 9 common factors: (1) selection bias; (2) performance and detection bias; (3) eligibility, intervention details, and description of outcome measures; (4) psychometric properties of the main outcome; (5) contamination and adherence to treatment; (6) attrition bias; (7) data analysis; (8) sample size; and (9) control and placebo adequacy. Because of the exploratory nature of the results, a confirmatory factor analysis is needed to validate this model. To the authors' knowledge, this is the first factor analysis to explore the underlying component items used to evaluate the methodological quality or risk of bias of RCTs in physical therapy. The items and factors represent a starting point for evaluating the methodological quality and risk of bias in physical therapy trials. Empirical evidence of the association among these items with treatment effects and a confirmatory factor analysis of these results are needed to validate these items.

  14. How well can we measure U and Pu on an interlaboratory basis?

    International Nuclear Information System (INIS)

    De Bievre, P.; Mayer, K.

    1991-01-01

    In measurements in general, and nuclear measurements in particular, it is no more a secret that the real state-of-the-practice (SOP) is frequently different from what is said at Conferences, written in books or claimed in meetings. Frequently the latter refer to the state-of-the-art (SOA) in research laboratories or to the ultimate possible only achievable in a few highly specialized institutes. Since it is important to have an objective basis to determine where the authors stand in SOP, CBNM is running a program to regularly determine the SOP on an interlaboratory basis for U and Pu element and isotope assay: REIMEP (Regular European Interlaboratory Measurement Evaluation Program). Participation is open to non-European countries. Well characterized samples are distributed to participants with characteristics undisclosed until participants' measurements have been received. Subsequently pictures are provided displaying (a) the interlaboratory spread, (b) the deviation of each participant to the carefully characterized reference value, (c) the participant's own estimate of his uncertainty allowing comparison with other participant's uncertainties and the uncertainty of the reference value. Thus the pictures act as instant photographs (snapshots) of the real SOP. The choice of the analytical method is up to the participant (titrimetry, coulometry, α-spectrometry, gas mass spectrometry, γ-spectrometry, thermionic mass spectrometry,...). The quoted uncertainty is also the participant's choice, but should be an accuracy defined as an uncertainty range claiming, for all practical purposes, to contain the true value. Up to now a number of rounds have been performed on various U and/or Pu containing materials such as pellets, powders, solutions, UF 6 . A number of graphs displaying the SOP will be shown

  15. Impact of Uniform Methods on Interlaboratory Antibody Titration Variability: Antibody Titration and Uniform Methods.

    Science.gov (United States)

    Bachegowda, Lohith S; Cheng, Yan H; Long, Thomas; Shaz, Beth H

    2017-01-01

    -Substantial variability between different antibody titration methods prompted development and introduction of uniform methods in 2008. -To determine whether uniform methods consistently decrease interlaboratory variation in proficiency testing. -Proficiency testing data for antibody titration between 2009 and 2013 were obtained from the College of American Pathologists. Each laboratory was supplied plasma and red cells to determine anti-A and anti-D antibody titers by their standard method: gel or tube by uniform or other methods at different testing phases (immediate spin and/or room temperature [anti-A], and/or anti-human globulin [AHG: anti-A and anti-D]) with different additives. Interlaboratory variations were compared by analyzing the distribution of titer results by method and phase. -A median of 574 and 1100 responses were reported for anti-A and anti-D antibody titers, respectively, during a 5-year period. The 3 most frequent (median) methods performed for anti-A antibody were uniform tube room temperature (147.5; range, 119-159), uniform tube AHG (143.5; range, 134-150), and other tube AHG (97; range, 82-116); for anti-D antibody, the methods were other tube (451; range, 431-465), uniform tube (404; range, 382-462), and uniform gel (137; range, 121-153). Of the larger reported methods, uniform gel AHG phase for anti-A and anti-D antibodies had the most participants with the same result (mode). For anti-A antibody, 0 of 8 (uniform versus other tube room temperature) and 1 of 8 (uniform versus other tube AHG), and for anti-D antibody, 0 of 8 (uniform versus other tube) and 0 of 8 (uniform versus other gel) proficiency tests showed significant titer variability reduction. -Uniform methods harmonize laboratory techniques but rarely reduce interlaboratory titer variance in comparison with other methods.

  16. Results of the 1988 interlaboratory comparison on the gamma spectrometry of dried whey

    International Nuclear Information System (INIS)

    Wiechen, A.; Tait, D.; Bundesanstalt fuer Milchforschung, Kiel

    1988-01-01

    Following the accident in Chernobyl in 1986 the number of units available for monitoring radioactivity, mainly gamma spectrometers, has been increased considerably in the Federal Republic of Germany. Furthermore, new legislation requires that all official monitoring laboratories verify the quality of their analytical technique by participating in interlaboratory comparison studies organized by Federal institutions. Such a study was therefore organized in March 1988. 86 laboratories collaborated on the gamma-spectrometry analysis of the radionuclides Cs-137, Cs-134 and K-40 in dried whey. This paper describes the statistical evaluation of the 144 sets of data received. The results of the study were surprisingly good. (orig./DG) [de

  17. Inter-laboratory comparison of cell lines for susceptibility to three viruses: VHSV, IHNV and IPNV

    DEFF Research Database (Denmark)

    Lorenzen, Ellen; Carstensen, Bendix; Olesen, Niels Jørgen

    1999-01-01

    Eleven European National Reference Laboratories participated in an inter-laboratory comparison of the susceptibility of 5 selected cell lines to 3 fish pathogenic viruses. The test included viral hemorrhagic septicaemia virus (VHSV), infectious hematopoietic necrosis virus (IHNV) and infectious...... pancreatic necrosis Virus (IPNV), and the cell lines derived from bluegill fry (BF-2), chinook salmon embryo (CHSE-214), epithelioma papulosum cyprini (EPC), fathead minnow (FHM) and rainbow trout gonad (RTG-2). The results showed that for isolation of VHSV, BF-2 and RTG-2 cells performed equally well...

  18. Interlaboratory comparison in the pressure range from 0 to 2 MPa for accredited calibration laboratories

    Directory of Open Access Journals (Sweden)

    Bermanec Lovorka Grgec

    2015-01-01

    Full Text Available This paper describes procedure and results of the interlaboratory comparison that was organised by Croatian national pressure laboratory (HMI/FSB-LPM between eight accredited pressure calibration laboratories. Comparison was performed in the gauge pressure range from 0 to 2 MPa with pressure transducer as transfer standard and using gas as transmitting medium. Basic aim of this comparison was to improve measurement methods and the measurement uncertainties of each participating laboratory. Analysis of the measurement results are given by calculating the deviation, En, normalized with respect to the stated measurement uncertainties.

  19. Participation in the 1999 IAEA interlaboratory comparison on chemical analysis of groundwater

    Energy Technology Data Exchange (ETDEWEB)

    Joe, Kih Soo; Choi, Kwang Soon; Han, Sun Ho; Suh, Moo Yul; Park, Kyung Kyun; Choi, Ke Chun; Kim, Won Ho

    2000-08-01

    KAERI analytical laboratory participated in the 1999 IAEA interlaboratory comparison on chemical analysis of groundwater organized by IAEA Hydrology Laboratory(RAS/8/084). 13 items such as pH, electroconductivity, HCO{sub 3}, Cl, SO{sub 4}, NO{sub 3}, SiO{sub 2}, B, Li, Na, K, Ca, Mg were analyzed. The result of this program showed that KAERI laboratory was ranked within 10% range from top level. An analytical expert in KAERI attended the 'Consultants' Meeting' at IAEA headquater and prepared the guideline for chemical analysis of groundwater.

  20. Participation in the 1999 IAEA interlaboratory comparison on chemical analysis of groundwater

    International Nuclear Information System (INIS)

    Joe, Kih Soo; Choi, Kwang Soon; Han, Sun Ho; Suh, Moo Yul; Park, Kyung Kyun; Choi, Ke Chun; Kim, Won Ho

    2000-08-01

    KAERI analytical laboratory participated in the 1999 IAEA interlaboratory comparison on chemical analysis of groundwater organized by IAEA Hydrology Laboratory(RAS/8/084). 13 items such as pH, electroconductivity, HCO 3 , Cl, SO 4 , NO 3 , SiO 2 , B, Li, Na, K, Ca, Mg were analyzed. The result of this program showed that KAERI laboratory was ranked within 10% range from top level. An analytical expert in KAERI attended the 'Consultants' Meeting' at IAEA headquater and prepared the guideline for chemical analysis of groundwater

  1. Reimiep 87. An interlaboratory U-235 enrichment determination by gamma measurement on solid UF6 sample

    International Nuclear Information System (INIS)

    Aparo, M.; Cresti, P.

    1988-01-01

    Gamma spectroscopy technique, based on the measurement of U 235 186 KeV flux, is now currently used for the determination of Uranium enrichment in different material of nuclear fuel cycle, namely: Uranium metallic, UO 2 pellets, UF 6 liquid or solid. The present paper describes the use of such a technique and the obtained results in determining the U 235 /U atomic isotopic abundance on a certified UF 6 solid sample. The measurements have been carried out in the frame work of the partecipation to the ''UF 6 Interlaboratory Measurements Evaluation Programme'' organized by CBNM/Geel with the support of the ESARDA (European Safeguards Research and Development Association)

  2. Assessing the Collective Population Representativeness of Related Type 2 Diabetes Trials by Combining Public Data from ClinicalTrials.gov and NHANES.

    Science.gov (United States)

    He, Zhe; Wang, Shuang; Borhanian, Elhaam; Weng, Chunhua

    2015-01-01

    Randomized controlled trials generate high-quality medical evidence. However, the use of unjustified inclusion/exclusion criteria may compromise the external validity of a study. We have introduced a method to assess the population representativeness of related clinical trials using electronic health record (EHR) data. As EHR data may not perfectly represent the real-world patient population, in this work, we further validated the method and its results using the National Health and Nutrition Examination Survey (NHANES) data. We visualized and quantified the differences in the distributions of age, HbA1c, and BMI among the target population of Type 2 diabetes trials, diabetics in NHANES databases, and a convenience sample of patients enrolled in selected Type 2 diabetes trials. The results are consistent with the previous study.

  3. An European inter-laboratory validation of alternative endpoints of the murine local lymph node assay: First round

    International Nuclear Information System (INIS)

    Ehling, G.; Hecht, M.; Heusener, A.; Huesler, J.; Gamer, A.O.; Loveren, H. van; Maurer, Th.; Riecke, K.; Ullmann, L.; Ulrich, P.; Vandebriel, R.; Vohr, H.-W.

    2005-01-01

    The new OECD guideline 429 (skin sensitization: local lymph node assay) is based upon a protocol, which utilises the incorporation of radioactivity into DNA as a measure for cell proliferation in vivo. The guideline also enables the use of alternative endpoints in order to assess draining lymph node (LN) cell proliferation. Here we describe the first round of an inter-laboratory validation of alternative endpoints in the LLNA conducted in seven laboratories. The validation study was managed and supervised by the Swiss Agency for Therapeutic Products, Swissmedic. Statistical analyses of all data were performed by an independent centre at the University of Bern, Department of Statistics. Ear-draining, LN weight and cell count were used to assess proliferation instead of radioactive labeling of lymph node cells. In addition, the acute inflammatory skin reaction was measured by ear swelling and weight of circular biopsies of the ears to identify skin irritating properties of the test items. Hexylcinnamaldehyde (HCA) and three blinded test items were applied to female, 8-10 weeks old NMRI and BALB/c mice. Results were sent via the independent study coordinator to the statistician. The results of this first round showed that the alternative endpoints of the LLNA are sensitive and robust parameters. The use of ear weights added an important parameter assessing the skin irritation potential, which supports the differentiation of pure irritative from contact allergenic potential. There were absolute no discrepancies between the categorisation of the three test substances A-C determined by each single participating laboratories. The results highlighted also that many parameters do have an impact on the strength of the responses. Therefore, such parameters have to be taken into consideration for the categorisation of compounds due to their relative sensitizing potencies

  4. The use of importance sampling in a trial assessment to obtain converged estimates of radiological risk

    International Nuclear Information System (INIS)

    Johnson, K.; Lucas, R.

    1986-12-01

    In developing a methodology for assessing potential sites for the disposal of radioactive wastes, the Department of the Environment has conducted a series of trial assessment exercises. In order to produce converged estimates of radiological risk using the SYVAC A/C simulation system an efficient sampling procedure is required. Previous work has demonstrated that importance sampling can substantially increase sampling efficiency. This study used importance sampling to produce converged estimates of risk for the first DoE trial assessment. Four major nuclide chains were analysed. In each case importance sampling produced converged risk estimates with between 10 and 170 times fewer runs of the SYVAC A/C model. This increase in sampling efficiency can reduce the total elapsed time required to obtain a converged estimate of risk from one nuclide chain by a factor of 20. The results of this study suggests that the use of importance sampling could reduce the elapsed time required to perform a risk assessment of a potential site by a factor of ten. (author)

  5. A framework for assessing immunological correlates of protection in vaccine trials.

    Science.gov (United States)

    Qin, Li; Gilbert, Peter B; Corey, Lawrence; McElrath, M Juliana; Self, Steven G

    2007-11-01

    A central goal of vaccine research is to identify a vaccine-induced immune response that predicts protection from infection or disease. The term "correlate of protection" has been used to refer to at least 3 distinct concepts, which has resulted in confusion surrounding this topic. We propose precise definitions of these different concepts of immune correlates, using the nomenclature "correlate of risk," "level 1 surrogate of protection," and "level 2 surrogate of protection." We suggest a general framework for assessing these 3 levels of immune correlates in vaccine efficacy trials. To demonstrate the proposed principles, we analyze data from a 1943 influenza vaccine field trial, supporting Weiss strain A-specific antibody titers as a level 1 surrogate of protection. Other real and simulated examples are also discussed.

  6. Quality assessment of delineation and dose planning of early breast cancer patients included in the randomized Skagen Trial 1

    DEFF Research Database (Denmark)

    Francolini, Giulio; Thomsen, Mette S; Yates, Esben S

    2017-01-01

    BACKGROUND AND PURPOSE: To report on a Quality assessment (QA) of Skagen Trial 1, exploring hypofractionation for breast cancer patients with indication for regional nodal radiotherapy. MATERIAL AND METHODS: Deviations from protocol regarding target volume delineations and dose parameters (Dmin...

  7. Inter-laboratory variability of haemoglobin measurements obtained ...

    African Journals Online (AJOL)

    Background: Accurate and precise tests results generated by clinical laboratories would assist correct decision making in the diagnosis and management of patients. Quality assurance, which comprises of internal quality control (IQC) and external quality assessment (EQA), is intended to ensure the reliability of the ...

  8. Evaluation of an online Diabetes Needs Assessment Tool (DNAT for health professionals: a randomised controlled trial

    Directory of Open Access Journals (Sweden)

    Kellner Thomas

    2009-07-01

    Full Text Available Abstract Background Continuous medical education is traditionally reliant to a large extent on self-directed learning based on individuals' perceived learning priorities. Evidence suggests that this ability to self-assess is limited, and more so in the least competent. Therefore, it may be of benefit to utilise some form of external assessment for this purpose. Many diabetes educational programmes have been introduced, but few have been assessed for their benefit in a systematic manner. As diabetes is an increasingly prevalent disease, methods for the dissemination and understanding of clinical guidelines need to be explored for their effectiveness. This paper describes the study design of a randomised controlled trial to evaluate the effectiveness of using an interactive online Diabetes Needs Assessment Tool (DNAT, that builds a learning curriculum based on identified knowledge gaps, compared with conventional self-directed learning. The study assesses the effect of these interventions on health professionals' knowledge of diabetes management, evaluates the acceptability of this process of learning and self-reported changes in clinical practice as a result of this novel educational process. Methods Following a baseline assessment, participants will be randomised to undergo a 4-month learning period where they will either be given access to the diabetes learning modules alone (control group or a Diabetes Needs Assessment Tool (DNAT plus the diabetes learning modules (intervention group. On completion of the DNAT, a personalised learning report will be created for each participant identifying needs alongside individualised recommendations of the most appropriate learning modules to meet those requirements. All participants will complete a Diabetes Knowledge Test before and immediately after the allocated learning and the primary outcome will be the state of knowledge at 4 months. Learners will also be surveyed immediately after the learning

  9. Interlaboratory comparison of δ13C and δD measurements of atmospheric CH4 for combined use of data sets from different laboratories

    Science.gov (United States)

    Umezawa, Taku; Brenninkmeijer, Carl A. M.; Röckmann, Thomas; van der Veen, Carina; Tyler, Stanley C.; Fujita, Ryo; Morimoto, Shinji; Aoki, Shuji; Sowers, Todd; Schmitt, Jochen; Bock, Michael; Beck, Jonas; Fischer, Hubertus; Michel, Sylvia E.; Vaughn, Bruce H.; Miller, John B.; White, James W. C.; Brailsford, Gordon; Schaefer, Hinrich; Sperlich, Peter; Brand, Willi A.; Rothe, Michael; Blunier, Thomas; Lowry, David; Fisher, Rebecca E.; Nisbet, Euan G.; Rice, Andrew L.; Bergamaschi, Peter; Veidt, Cordelia; Levin, Ingeborg

    2018-03-01

    We report results from a worldwide interlaboratory comparison of samples among laboratories that measure (or measured) stable carbon and hydrogen isotope ratios of atmospheric CH4 (δ13C-CH4 and δD-CH4). The offsets among the laboratories are larger than the measurement reproducibility of individual laboratories. To disentangle plausible measurement offsets, we evaluated and critically assessed a large number of intercomparison results, some of which have been documented previously in the literature. The results indicate significant offsets of δ13C-CH4 and δD-CH4 measurements among data sets reported from different laboratories; the differences among laboratories at modern atmospheric CH4 level spread over ranges of 0.5 ‰ for δ13C-CH4 and 13 ‰ for δD-CH4. The intercomparison results summarized in this study may be of help in future attempts to harmonize δ13C-CH4 and δD-CH4 data sets from different laboratories in order to jointly incorporate them into modelling studies. However, establishing a merged data set, which includes δ13C-CH4 and δD-CH4 data from multiple laboratories with desirable compatibility, is still challenging due to differences among laboratories in instrument settings, correction methods, traceability to reference materials and long-term data management. Further efforts are needed to identify causes of the interlaboratory measurement offsets and to decrease those to move towards the best use of available δ13C-CH4 and δD-CH4 data sets.

  10. Quality assessment of reports on clinical trials in the Journal of Hepatology

    DEFF Research Database (Denmark)

    Gluud, C; Nikolova, D

    1998-01-01

    Electronic searches on databases for randomised clinical trials and controlled clinical trials do not identify as many trials as handsearches, and trial reporting may be flawed. The aims were to identify all fully reported randomised clinical trials in the Journal of Hepatology and to make...

  11. The importance of assessing behaviour and cognition in antiepileptic drug trials in children and adolescents.

    Science.gov (United States)

    Lagae, Lieven

    2017-06-01

    It has long been recognised that uncontrolled childhood epilepsy is detrimental to cognition and behaviour, impacting on a patient's ability to succeed academically. Patients who experience more frequent and serious seizures are at greater risk for cognitive decline, emphasising the need for more effective epilepsy treatments to bring seizures under control. That said, although more effective antiepileptic drugs (AEDs) have the potential to limit the impact of uncontrolled seizures on cognitive and behavioural function, recently it has been acknowledged that deficits in these functions may be caused by AEDs themselves. The cognitive and behavioural effects of older-generation AEDs have been determined largely from AE reporting rather than from specific assessment. Recently, clinical trials of newer-generation AEDs, such as topiramate, levetiracetam and perampanel, have included standardised neuropsychological tests as outcome measures to assess their impact on cognition and behaviour in children and adolescents. However, to understand how we may limit the cognitive and behavioural side effects of AEDs, it is necessary for us to gain a fuller, more accurate, characterisation of their true impact. Such insight will depend on sophisticated and standardised approaches to the design of AED clinical trials. This review provides a general overview of our current understanding of the impact of both epilepsy and AEDs on cognition and behaviour, before focusing on the AEDs for which more detailed assessment, using standardised cognitive and behavioural measures, has been undertaken. We will then go on to discuss the key elements in the design of future AED clinical trials to address current unmet needs.

  12. Validation of a PCR-based method for detection of food-borne thermotolerant Campylobacters in a multicenter collaborative trial

    DEFF Research Database (Denmark)

    Josefsen, Mathilde Hartmann; Cook, N.; D'Agostino, M.

    2004-01-01

    A PCR-based method for rapid detection of food-borne thermotolerant campylobacters was evaluated through a collaborative trial with 12 laboratories testing spiked carcass rinse samples. The method showed an interlaboratory diagnostic sensitivity of 96.7% and a diagnostic specificity of 100...

  13. An interlaboratory comparison between similar methods for determination of melatonin, cortisol and testosterone in saliva.

    Science.gov (United States)

    Jensen, Marie A; Mortier, Leen; Koh, Eitetsu; Keevil, Brian; Hyttinen, Sirpa; Hansen, Åse M

    2014-08-01

    An interlaboratory comparison study for melatonin, cortisol and testosterone in saliva in which five laboratories participated is reported in this study. Each laboratory blindly measured eight samples prepared from natural saliva spiked with melatonin, cortisol and testosterone in the range 0-579 pmol/L for melatonin, 0-90 nmol/L for cortisol, and 0-622 pmol/L for testosterone. The recovery of spiked material for melatonin ranged from 91-110%, from 83-100% for cortisol and from 80-94% for testosterone. The content of natural hormone in saliva was estimated to be between 0.278 and 6.90 pmol/L for melatonin, 0.56 and 6.72 nmol/L for cortisol and 11.9 and 73.8 pmol/L for testosterone. This indicates a large interlaboratory variation. The present study emphasizes the importance of external quality control for the analysis of melatonin, cortisol and testosterone in saliva.

  14. An Interlaboratory Evaluation of Drift Tube Ion Mobility–Mass Spectrometry Collision Cross Section Measurements

    Energy Technology Data Exchange (ETDEWEB)

    Stow, Sarah M. [Department; Causon, Tim J. [Division; Zheng, Xueyun [Biological; Kurulugama, Ruwan T. [Agilent Technologies, Santa Clara, California 95051, United States; Mairinger, Teresa [Division; May, Jody C. [Department; Rennie, Emma E. [Agilent Technologies, Santa Clara, California 95051, United States; Baker, Erin S. [Biological; Smith, Richard D. [Biological; McLean, John A. [Department; Hann, Stephan [Division; Fjeldsted, John C. [Agilent Technologies, Santa Clara, California 95051, United States

    2017-08-14

    Collision cross section (CCS) measurements resulting from ion mobility-mass spectrometry (IM-MS) experiments provide a promising orthogonal dimension of structural information in MS-based analytical separations. As with any molecular identifier, interlaboratory standardization must precede broad range integration into analytical workflows. In this study, we present a reference drift tube ion mobility mass spectrometer (DTIM-MS) where improvements on the measurement accuracy of experimental parameters influencing IM separations provide standardized drift tube, nitrogen CCS values (DTCCSN2) for over 120 unique ion species with the lowest measurement uncertainty to date. The reproducibility of these DTCCSN2 values are evaluated across three additional laboratories on a commercially available DTIM-MS instrument. The traditional stepped field CCS method performs with a relative standard deviation (RSD) of 0.29% for all ion species across the three additional laboratories. The calibrated single field CCS method, which is compatible with a wide range of chromatographic inlet systems, performs with an average, absolute bias of 0.54% to the standardized stepped field DTCCSN2 values on the reference system. The low RSD and biases observed in this interlaboratory study illustrate the potential of DTIM-MS for providing a molecular identifier for a broad range of discovery based analyses.

  15. Effective dose assessment for participants in the National Lung Screening Trial undergoing posteroanterior chest radiographic examinations.

    Science.gov (United States)

    Kruger, Randell; Flynn, Michael J; Judy, Phillip F; Cagnon, Christopher H; Seibert, J Anthony

    2013-07-01

    The National Lung Screening Trial (NLST) is a multicenter randomized controlled trial comparing low-dose helical CT with chest radiography in the screening of older current and former heavy smokers for early detection of lung cancer. Recruitment was launched in September 2002 and ended in April 2004, when 53,454 participants had been randomized at 33 screening sites. The objective of this study was to determine the effective radiation dose associated with individual chest radiographic screening examinations. A total of 73,733 chest radiographic examinations were performed with 92 chest imaging systems. The entrance skin air kerma (ESAK) of participants' chest radiographic examinations was estimated and used in this analysis. The effective dose per ESAK for each examination was determined with a Monte Carlo-based program. The examination effective dose was calculated as the product of the examination ESAK and the Monte Carlo estimate of the ratio of effective dose per ESAK. This study showed that the mean effective dose assessed from 66,157 postero-anterior chest examinations was 0.052 mSv. Additional findings were a median effective dose of 0.038 mSv, a 95th percentile value of 0.136 mSv, and a fifth percentile value of 0.013 mSv. The effective dose for participant NLST chest radiographic examinations was determined and is of specific interest in relation to that associated with the previously published NLST low-dose CT examinations conducted during the trial.

  16. Assessing the treatment effect from multiple trials in idiopathic pulmonary fibrosis

    Directory of Open Access Journals (Sweden)

    L. Richeldi

    2012-06-01

    Full Text Available The magnitude of treatment effect can be assessed by a number of methods. One method of collectively analysing data is that used by the Cochrane Collaboration. Their systematic reviews identify, analyse and present research-based evidence in an accessible format. These reviews may contain meta-analyses combining data from multiple studies to provide robust evaluations of overall treatment effects. In 2003, Cochrane reviews of data for treatment with corticosteroids in idiopathic pulmonary fibrosis (IPF found no evidence supporting their use; similarly, reviews of immunomodulatory agents found very little evidence to support their use. A recent update of these Cochrane reviews failed to identify any evidence supporting the use of corticosteroids in IPF; however, a review of non-steroid agents in the treatment of IPF identified 15 clinical trials suitable for analysis. Two trials of interferon-γ-1b were combined, and no treatment effect was observed in terms of survival. Two Japanese trials of treatment with pirfenidone were combined, and a positive effect of pirfenidone on pulmonary function decline was observed. Meta-analysis of three phase III studies suggested that pirfenidone significantly increased progression-free survival by 30%. The findings of this systematic review, although not presenting new original data, together with an acceptable safety profile, suggest that pirfenidone may have a role in IPF treatment.

  17. PErineal Assessment and Repair Longitudinal Study (PEARLS: protocol for a matched pair cluster trial

    Directory of Open Access Journals (Sweden)

    Thomas Peter W

    2010-02-01

    Full Text Available Abstract Background The Perineal Assessment and Repair Longitudinal Study (PEARLS is a national clinical quality improvement initiative designed to improve the assessment and management of perineal trauma. Perineal trauma affects around 85% of women who have a vaginal birth in the UK each year and millions more world-wide. Continuous suturing techniques compared with traditional interrupted methods are more effective in reducing pain and postnatal morbidity, however they are not widely used by clinicians despite recommendations of evidence based national clinical guidelines. Perineal suturing skills and postnatal management of trauma remain highly variable within and between maternity units in the UK as well as worldwide. Implementation of a standardised training package to support effective perineal management practices could reduce perineal pain and other related postnatal morbidity for a substantial number of women. Methods/Design PEARLS is a matched pair cluster trial, which is being conducted in maternity units across the UK. Units within a matched pair will be randomised to implement the study intervention either early or late in the study period. The intervention will include the cascading of a multi-professional training package to enhance midwifery and obstetric skills in the assessment, repair and postnatal management of perineal trauma. Women who have had an episiotomy or second degree perineal tear will be eligible for recruitment. Prior to developing the intervention and deciding on study outcomes, a Delphi survey and a consensus conference were held to identify what women, who previously suffered perineal trauma during childbirth, considered to be important outcomes for them. Findings from this preliminary work (which will be reported elsewhere and other outcomes including women's experiences of perineal pain and pain on activity, breastfeeding uptake and duration and psychological well-being as assessed using the Edinburgh

  18. On the application of ICP-MS techniques for measuring uranium and plutonium: a Nordic inter-laboratory comparison exercise

    DEFF Research Database (Denmark)

    Qiao, Jixin; Lagerkvist, Petra; Rodushkin, Ilia

    2018-01-01

    sensitivity and short measurement time. In this work, an inter-laboratory comparison exercise among the Nordic countries was performed, focusing on the measurement of U and Pu isotopes in certified reference materials by ICP-MS. The performance and characters of different ICP-MS instruments are evaluated...

  19. Confirmation of synthetic glucocorticoids with liquid chromatography/mass spectrometry: Organization and results of an international interlaboratory comparison test

    NARCIS (Netherlands)

    Hauwe, O. van den; Campbell, K.; Crooks, S.R.H.; Schilt, R.; Peteghem, C.H. van

    2005-01-01

    Within the framework of a European Union (EU) research project entitled "Food Safety Screening: Synthetic Glucocorticoids (QLK1-1999-00122)," an international interlaboratory ring test was organized to compare and evaluate different liquid chromatography/mass spectrometry (LC/MS) confirmatory

  20. Liquid chromatographic determination of aflatoxin M1 in milk powder using immunoaffinity columns for cleanup : interlaboratory study

    NARCIS (Netherlands)

    Tuinstra, L G; Roos, A H; van Trijp, J M

    1993-01-01

    A liquid chromatographic method for determining low aflatoxin M1 concentrations in milk was evaluated in an International Dairy Federation (IDF) interlaboratory study. The study involved 16 participants from 11 countries. The method, chosen after a comparison of several methods by a preparatory

  1. First worldwide UNEP interlaboratory study on persistent organic pollutants (POPs) with data on polychlorinated biphenyls and organochlorine pesticides

    NARCIS (Netherlands)

    Leeuwen, van S.P.J.; Bavel, van B.; Boer, de J.

    2013-01-01

    The first worldwide interlaboratory study on persistent organic pollutants (POPs) under the Stockholm Convention was organized, with a participation of 103 laboratories from Asia, Europe, the Americas, Africa and Australia, of which the majority submitted data on polychlorinated biphenyls (PCBs) and

  2. Interlaboratory tests to identify irradiation treatment of various foods via gas chromatographic detection of hydrocarbons, ESR spectroscopy and TL analysis

    International Nuclear Information System (INIS)

    Schreiber, G.A.; Helle, N.; Schulzki, G.; Linke, B.; Spiegelberg, A.; Mager, M.; Boegl, K.W.

    1996-01-01

    The gas chromatographic (GC) analysis of radiation-induced volatile hydrocarbons (HC) and 2-alkylcyclobutanones, the ESR spectroscopic detection of radiation-specific radicals and the thermoluminescence (TL) analysis of silicate mineral are the most important methods for identification of irradiated foods. After successful performance in interlaboratory studies on meat products, fish, spices, herbs and shells of nuts, all or some of these methods have been approved by national authorities in Germany and the United Kingdom. Recently, draft European Standards have been elaborated for approval by member states of the European Committee for Standardization (CEN). Several research laboratories have shown that these methods can be applied to various foods not yet tested in collaborative studies. However, for an effective application in food control it is necessary to prove their suitability in interlaboratory studies. Therefore, in 1993/94, various interlaboratory tests were organised by the BgVV. In an ESR spectroscopic test, shrimps and paprika powder were examined. Shrimps were also the subject of examination in a TL test. Finally, GC detection of radiation-induced hydrocarbons in the fat fraction of foods was used in another test to identify irradiated Camembert, avocado, papaya and mango. In the following paper, results of the interlaboratory tests are summarised. Detailed reports are published by this institute. (author)

  3. Validation of three rapid screening methods for detection of verotoxin-producing Escherichia coli in foods : interlaboratory study

    NARCIS (Netherlands)

    Capps, K.L.; McLaughlin, E.M.; Murray, A.W.A.; Aldus, C.F.; Wyatt, G.M.; Peck, M.W.; Amerongen, van A.; Ariens, R.M.C.; Wichers, J.H.; Bayliss, C.L.; Wareing, D.R.A.; Bolton, F.J.

    2004-01-01

    An interlaboratory study was conducted for the validation of 3 methods for the detection of all verotoxin-producing Escherichia coli (VTEC) in foods. The methods were a multi-analyte 1-step lateral flow immunoassay (LFIA) for detection of E. coli O157 and verotoxin (VT); an enzyme-linked

  4. Interlaboratory tests to identify irradiation treatment of various foods via gas chromatographic detection of hydrocarbons, ESR spectroscopy and TL analysis

    Energy Technology Data Exchange (ETDEWEB)

    Schreiber, G.A.; Helle, N.; Schulzki, G.; Linke, B.; Spiegelberg, A.; Mager, M.; Boegl, K.W. [BgVV - Federal Inst. for Health Protection of Consumers and Veterinary Medicine, Berlin (Germany)

    1996-12-31

    The gas chromatographic (GC) analysis of radiation-induced volatile hydrocarbons (HC) and 2-alkylcyclobutanones, the ESR spectroscopic detection of radiation-specific radicals and the thermoluminescence (TL) analysis of silicate mineral are the most important methods for identification of irradiated foods. After successful performance in interlaboratory studies on meat products, fish, spices, herbs and shells of nuts, all or some of these methods have been approved by national authorities in Germany and the United Kingdom. Recently, draft European Standards have been elaborated for approval by member states of the European Committee for Standardization (CEN). Several research laboratories have shown that these methods can be applied to various foods not yet tested in collaborative studies. However, for an effective application in food control it is necessary to prove their suitability in interlaboratory studies. Therefore, in 1993/94, various interlaboratory tests were organised by the BgVV. In an ESR spectroscopic test, shrimps and paprika powder were examined. Shrimps were also the subject of examination in a TL test. Finally, GC detection of radiation-induced hydrocarbons in the fat fraction of foods was used in another test to identify irradiated Camembert, avocado, papaya and mango. In the following paper, results of the interlaboratory tests are summarised. Detailed reports are published by this institute. (author).

  5. Randomized controlled trials in the journal of sexual medicine: a quality assessment and relevant clinical impact.

    Science.gov (United States)

    Jo, Jung Ki; Chung, Jae Hoon; Kim, Kyu Shik; Lee, Jeong Woo; Lee, Seung Wook

    2014-04-01

    Quality assessment of randomized clinical trials (RCTs) is important to prevent the adoption of findings of low-quality trials into clinical practice. The aim if this study was to analyze the quality of studies reporting RCTs in the Journal of Sexual Medicine (JSM) and to find relevant clinical impact. A quality assessment was conducted in all studies identified as RCTs published in the JSM from 2004 to 2012. The review period was divided into three periods: early (2004-2006), mid (2007-2009), and late (2010-2012). The Jadad scale, van Tulder scale, and the Cochrane Collaboration Risk of Bias Tool (CCRBT) quality scoring instruments were used. The RCTs were also categorized by country of origin, topic, the inclusion of institutional review board (IRB) approval, funding, citation rate, and impact factor. A total of 2,418 original articles were published in the JSM during the review period, and 188 were reports of RCTs. There were 39 (14.89%), 70 (7.77%), and 76 (6.29%) RCTs published during the early, mid, and late terms, respectively (P Citation rates and impact factor were not correlated with RCT quality using any of the tools. The number of original articles and RCTs published in the JSM increased over time. However, the ratio of RCTs to original articles did not increase significantly. Adequate randomization and blinding methods, IRB review, and financial support are required for the conduct of high-quality RCTs. © 2014 International Society for Sexual Medicine.

  6. Assessing quality of reports on randomized clinical trials in nursing journals.

    Science.gov (United States)

    Parent, Nicole; Hanley, James A

    2009-01-01

    Several surveys have presented the quality of reports on randomized clinical trials (RCTs) published in general and specialty medical journals. The aim of these surveys was to raise scientific consciousness on methodological aspects pertaining to internal and external validity. These reviews have suggested that the methodological quality could be improved. We conducted a survey of reports on RCTs published in nursing journals to assess their methodological quality. The features we considered included sample size, flow of participants, assessment of baseline comparability, randomization, blinding, and statistical analysis. We collected data from all reports of RCTs published between January 1994 and December 1997 in Applied Nursing Research, Heart & Lung and Nursing Research. We hand-searched the journals and included all 54 articles in which authors reported that individuals have been randomly allocated to distinct groups. We collected data using a condensed form of the Consolidated Standards of Reporting Trials (CONSORT) statement for structured reporting of RCTs (Begg et al., 1996). Sample size calculations were included in only 22% of the reports. Only 48% of the reports provided information about the type of randomization, and a mere 22% described blinding strategies. Comparisons of baseline characteristics using hypothesis tests were abusively produced in more than 76% of the reports. Excessive use and unstructured reports of significance testing were common (59%), and all reports failed to provide magnitude of treatment differences with confidence intervals. Better methodological quality in reports of RCTs will contribute to increase the standards of nursing research.

  7. Randomized controlled trial in rural Ethiopia to assess a portable water treatment device.

    Science.gov (United States)

    Boisson, Sophie; Schmidt, Wolf-Peter; Berhanu, Tsegahiwot; Gezahegn, Henock; Clasen, Thomas

    2009-08-01

    We conducted a randomized controlled trial to assess the Lifestraw Personal pipe-style water treatment device among a rural population in Ethiopia. A total of 313 households (including 1516 persons) were randomly assigned either to an intervention group in which each householder received a Lifestraw Personal or a control. Households were visited fortnightly over a five-month intervention period and asked to report any episode of diarrhea during the previous week. A random sample of 160 devices was tested each month to assess the presence of thermotolerant coliforms (TTC) and residual iodine in treated water and to measure flow rate under simulated use. Members of the intervention group had 25% fewer weeks with diarrhea than those of the control group (longitudinal prevalence ratio = 0.75; 95% CI 0.60; 0.95). All 718 filtered water samples were free of TTC, were free of detectable iodine disinfectant, and showed a constant flow rate over time. After the five-month intervention period, 34% of participants reported use of device in the preceding week and 13% reported consistent use. While the device was associated with a 25% reduction in longitudinal prevalence of diarrhea, low levels of use suggest that much of this effect is likely to be attributable to reporting bias that is common in open trials with nonobjective outcomes.

  8. The quality assessment of the interventional radiology publications in Chinese journal of radiology using the randomized controlled trials

    International Nuclear Information System (INIS)

    Gao Xiangtao; Xu Guohui; He Hong; Yan Yaiying; Mao Bing

    2007-01-01

    Objective: To assess the quality of reporting randomized controlled trials published in Chinese journal of radiology from 2000 to 2005. Methods: A manual search was performed and 22 checklists of CONSORT statements and other self-established criteria were applied. Results: Six volumes and 72 issues were investigated. There were total trials of 236 in 2186 literatures, and finally 3 randomized controlled trials (RCTs) (1.27%) were identified. In the 3 RCTs, there were 3 trials with methods of randomization, 1 with endpoints measurement, 1 with multi-centre, but without the prior calculation of sample size, blind methods, statistically probability, participant flow, compliance and negative results. Conclusion: The quality of reporting randomized controlled trials of interventional radiology has been improved, but it did not meet fully the CONSORT statement. (authors)

  9. Post hoc interlaboratory comparison of single particle ICP-MS size measurements of NIST gold nanoparticle reference materials.

    Science.gov (United States)

    Montoro Bustos, Antonio R; Petersen, Elijah J; Possolo, Antonio; Winchester, Michael R

    2015-09-01

    Single particle inductively coupled plasma-mass spectrometry (spICP-MS) is an emerging technique that enables simultaneous measurement of nanoparticle size and number quantification of metal-containing nanoparticles at realistic environmental exposure concentrations. Such measurements are needed to understand the potential environmental and human health risks of nanoparticles. Before spICP-MS can be considered a mature methodology, additional work is needed to standardize this technique including an assessment of the reliability and variability of size distribution measurements and the transferability of the technique among laboratories. This paper presents the first post hoc interlaboratory comparison study of the spICP-MS technique. Measurement results provided by six expert laboratories for two National Institute of Standards and Technology (NIST) gold nanoparticle reference materials (RM 8012 and RM 8013) were employed. The general agreement in particle size between spICP-MS measurements and measurements by six reference techniques demonstrates the reliability of spICP-MS and validates its sizing capability. However, the precision of the spICP-MS measurement was better for the larger 60 nm gold nanoparticles and evaluation of spICP-MS precision indicates substantial variability among laboratories, with lower variability between operators within laboratories. Global particle number concentration and Au mass concentration recovery were quantitative for RM 8013 but significantly lower and with a greater variability for RM 8012. Statistical analysis did not suggest an optimal dwell time, because this parameter did not significantly affect either the measured mean particle size or the ability to count nanoparticles. Finally, the spICP-MS data were often best fit with several single non-Gaussian distributions or mixtures of Gaussian distributions, rather than the more frequently used normal or log-normal distributions.

  10. Improving assessment of paediatric acute breathing difficulties in medical education: a cluster randomized controlled trial.

    Science.gov (United States)

    Manikam, Logan; Blackwell, Nicholas; Banerjee, Jaydip; Nightingale, Peter; Lakhanpaul, Monica

    2013-05-01

    Impact assessment of an adjunct to standard teaching on knowledge gain and self-assessed confidence for students undertaking their paediatric attachment and evaluation of an acute breathing difficulties (ABDs) learning package. Pragmatic cluster randomized controlled trial involving 248 UK medical undergraduates within six paediatric clinical rotations. Intervention groups received an online ABD learning package consisting of symptom-based decision-making pathways underpinned by a ratified ABD evidence-based guideline. Control groups received an online dummy package. Outcome measures were a pre- and post-intervention multiple choice question assessment and confidence questionnaire utilising 5-point Likert scales. Significant knowledge gain in the intervention group (mean 6.84, 95% CI 5.56-8.12) versus no such difference in the control group, significant improvement in self-assessed confidence in intervention group versus no such difference in control group and significant confidence differences in ABD-specific statements were noted. In the satisfaction questionnaire, the learning content was noted to be new to only 16% participants. Supplementation of standard teaching with an interactive delivery method resulted in cognitive gain and self-assessed confidence improvement in interaction with children with ABDs. This indicates that a well-designed tool can help prepare students for direct interaction with sick children as a junior clinician. ISRCTN27499282. ©2013 The Author(s)/Acta Paediatrica ©2013 Foundation Acta Paediatrica.

  11. Cartographic Mapping and Travel Burden to Assess and Develop Strategies to Improve Minority Access to National Cancer Clinical Trials

    Energy Technology Data Exchange (ETDEWEB)

    Bruner, Deborah Watkins, E-mail: deborah.w.bruner@emory.edu [Emory University, Atlanta, Georgia (United States); Pugh, Stephanie L. [NRG Oncology Statistics and Data Management Center, Philadelphia, Pennsylvania (United States); Yeager, Katherine A.; Bruner, Jesse; Curran, Walter [Emory University, Atlanta, Georgia (United States)

    2015-11-01

    Purpose: To assess how accrual to clinical trials is related to US minority population density relative to clinical trial site location and distance traveled to Radiation Therapy Oncology Group (RTOG) clinical trial sites. Methods and Materials: Data included member site address and ZIP codes, patient accrual, and patient race or ethnicity and ZIP code. Geographic Information System maps were developed for overall, Latino, and African American accrual to trials by population density. The Kruskal-Wallis test was used to assess differences in distance traveled by site, type of trial, and race or ethnicity. Results: From 2006 to 2009, 6168 patients enrolled on RTOG trials. The RTOG US site distribution is generally concordant with overall population density. Sites with highest accrual are located throughout the United States and parts of Canada and do not cluster, nor does highest minority accrual cluster in areas of highest US minority population density. Of the 4913 US patients with complete data, patients traveled a median of 11.6 miles to participate in clinical trials. Whites traveled statistically longer distances (12.9 miles; P<.0001) to participate, followed by Latinos (8.22 miles) and African Americans (5.85 miles). Patients were willing to drive longer distances to academic sites than community sites, and there was a trend toward significantly longer median travel for therapeutic versus cancer control or metastatic trials. Conclusions: Location matters, but only to a degree, for minority compared with nonminority participation in clinical trials. Geographic Information System tools help identify gaps in geographic access and travel burden for clinical trials participation. Strategies that emerged using these tools are discussed.

  12. Cartographic Mapping and Travel Burden to Assess and Develop Strategies to Improve Minority Access to National Cancer Clinical Trials

    International Nuclear Information System (INIS)

    Bruner, Deborah Watkins; Pugh, Stephanie L.; Yeager, Katherine A.; Bruner, Jesse; Curran, Walter

    2015-01-01

    Purpose: To assess how accrual to clinical trials is related to US minority population density relative to clinical trial site location and distance traveled to Radiation Therapy Oncology Group (RTOG) clinical trial sites. Methods and Materials: Data included member site address and ZIP codes, patient accrual, and patient race or ethnicity and ZIP code. Geographic Information System maps were developed for overall, Latino, and African American accrual to trials by population density. The Kruskal-Wallis test was used to assess differences in distance traveled by site, type of trial, and race or ethnicity. Results: From 2006 to 2009, 6168 patients enrolled on RTOG trials. The RTOG US site distribution is generally concordant with overall population density. Sites with highest accrual are located throughout the United States and parts of Canada and do not cluster, nor does highest minority accrual cluster in areas of highest US minority population density. Of the 4913 US patients with complete data, patients traveled a median of 11.6 miles to participate in clinical trials. Whites traveled statistically longer distances (12.9 miles; P<.0001) to participate, followed by Latinos (8.22 miles) and African Americans (5.85 miles). Patients were willing to drive longer distances to academic sites than community sites, and there was a trend toward significantly longer median travel for therapeutic versus cancer control or metastatic trials. Conclusions: Location matters, but only to a degree, for minority compared with nonminority participation in clinical trials. Geographic Information System tools help identify gaps in geographic access and travel burden for clinical trials participation. Strategies that emerged using these tools are discussed.

  13. Recruitment and retention of participants in randomised controlled trials: a review of trials funded and published by the United Kingdom Health Technology Assessment Programme.

    Science.gov (United States)

    Walters, Stephen J; Bonacho Dos Anjos Henriques-Cadby, Inês; Bortolami, Oscar; Flight, Laura; Hind, Daniel; Jacques, Richard M; Knox, Christopher; Nadin, Ben; Rothwell, Joanne; Surtees, Michael; Julious, Steven A

    2017-03-20

    Substantial amounts of public funds are invested in health research worldwide. Publicly funded randomised controlled trials (RCTs) often recruit participants at a slower than anticipated rate. Many trials fail to reach their planned sample size within the envisaged trial timescale and trial funding envelope. To review the consent, recruitment and retention rates for single and multicentre randomised control trials funded and published by the UK's National Institute for Health Research (NIHR) Health Technology Assessment (HTA) Programme. HTA reports of individually randomised single or multicentre RCTs published from the start of 2004 to the end of April 2016 were reviewed. Information was extracted, relating to the trial characteristics, sample size, recruitment and retention by two independent reviewers. Target sample size and whether it was achieved; recruitment rates (number of participants recruited per centre per month) and retention rates (randomised participants retained and assessed with valid primary outcome data). This review identified 151 individually RCTs from 787 NIHR HTA reports. The final recruitment target sample size was achieved in 56% (85/151) of the RCTs and more than 80% of the final target sample size was achieved for 79% of the RCTs (119/151). The median recruitment rate (participants per centre per month) was found to be 0.92 (IQR 0.43-2.79) and the median retention rate (proportion of participants with valid primary outcome data at follow-up) was estimated at 89% (IQR 79-97%). There is considerable variation in the consent, recruitment and retention rates in publicly funded RCTs. Investigators should bear this in mind at the planning stage of their study and not be overly optimistic about their recruitment projections. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing/.

  14. HElmet therapy Assessment in infants with Deformed Skulls (HEADS: protocol for a randomised controlled trial

    Directory of Open Access Journals (Sweden)

    van Wijk Renske M

    2012-07-01

    Full Text Available Abstract Background In The Netherlands, helmet therapy is a commonly used treatment in infants with skull deformation (deformational plagiocephaly or deformational brachycephaly. However, evidence of the effectiveness of this treatment remains lacking. The HEADS study (HElmet therapy Assessment in Deformed Skulls aims to determine the effects and costs of helmet therapy compared to no helmet therapy in infants with moderate to severe skull deformation. Methods/design Pragmatic randomised controlled trial (RCT nested in a cohort study. The cohort study included infants with a positional preference and/or skull deformation at two to four months (first assessment. At 5 months of age, all children were assessed again and infants meeting the criteria for helmet therapy were asked to participate in the RCT. Participants were randomly allocated to either helmet therapy or no helmet therapy. Parents of eligible infants that do not agree with enrolment in the RCT were invited to stay enrolled for follow up in a non-randomisedrandomised controlled trial (nRCT; they were then free to make the decision to start helmet therapy or not. Follow-up assessments took place at 8, 12 and 24 months of age. The main outcome will be head shape at 24 months that is measured using plagiocephalometry. Secondary outcomes will be satisfaction of parents and professionals with the appearance of the child, parental concerns about the future, anxiety level and satisfaction with the treatment, motor development and quality of life of the infant. Finally, compliance and costs will also be determined. Discussion HEADS will be the first study presenting data from an RCT on the effectiveness of helmet therapy. Outcomes will be important for affected children and their parents, health care professionals and future treatment policies. Our findings are likely to influence the reimbursement policies of health insurance companies. Besides these health outcomes, we will be able to

  15. Assessing Adherence in the CAPRISA 004 Tenofovir Gel HIV Prevention Trial: Results of a Nested Case–Control Study

    OpenAIRE

    MacQueen, Kathleen M.; Weaver, Mark A.; van Loggerenberg, Francois; Succop, Stacey; Majola, Nelisle; Taylor, Doug; Karim, Quarraisha Abdool; Karim, Salim Abdool

    2014-01-01

    Adherence undeniably impacts product effectiveness in microbicide trials, but the connection has proven challenging to quantify using routinely collected behavioral data. We explored this relationship using a nested case–control study in the CAPRISA 004 Tenofovir (TFV) gel HIV prevention trial. Detailed 3-month recall data on sex events, condom and gel use were collected from 72 incident cases and 205 uninfected controls. We then assessed how the relationship between self-reported adherence a...

  16. Standardization of reflectance measurements in dispersed organic matter: results of an exercise to improve interlaboratory agreement

    Science.gov (United States)

    Hackley, Paul C.; Araujo, Carla Viviane; Borrego, Angeles G.; Bouzinos, Antonis; Cardott, Brian; Cook, Alan C.; Eble, Cortland; Flores, Deolinda; Gentzis, Thomas; Gonçalves, Paula Alexandra; Filho, João Graciano Mendonça; Hámor-Vidó, Mária; Jelonek, Iwona; Kommeren, Kees; Knowles, Wayne; Kus, Jolanta; Mastalerz, Maria; Menezes, Taíssa Rêgo; Newman, Jane; Pawlewicz, Mark; Pickel, Walter; Potter, Judith; Ranasinghe, Paddy; Read, Harold; Reyes, Julito; Rodriguez, Genaro De La Rosa; de Souza, Igor Viegas Alves Fernandes; Suarez-Ruiz, Isabel; Sýkorová, Ivana; Valentine, Brett J.

    2015-01-01

    Vitrinite reflectance generally is considered the most robust thermal maturity parameter available for application to hydrocarbon exploration and petroleum system evaluation. However, until 2011 there was no standardized methodology available to provide guidelines for vitrinite reflectance measurements in shale. Efforts to correct this deficiency resulted in publication of ASTM D7708: Standard test method for microscopical determination of the reflectance of vitrinite dispersed in sedimentary rocks. In 2012-2013, an interlaboratory exercise was conducted to establish precision limits for the D7708 measurement technique. Six samples, representing a wide variety of shale, were tested in duplicate by 28 analysts in 22 laboratories from 14 countries. Samples ranged from immature to overmature (0.31-1.53% Ro), from organic-lean to organic-rich (1-22 wt.% total organic carbon), and contained Type I (lacustrine), Type II (marine), and Type III (terrestrial) kerogens. Repeatability limits (maximum difference between valid repetitive results from same operator, same conditions) ranged from 0.03-0.11% absolute reflectance, whereas reproducibility limits (maximum difference between valid results obtained on same test material by different operators, different laboratories) ranged from 0.12-0.54% absolute reflectance. Repeatability and reproducibility limits degraded consistently with increasing maturity and decreasing organic content. However, samples with terrestrial kerogens (Type III) fell off this trend, showing improved levels of reproducibility due to higher vitrinite content and improved ease of identification. Operators did not consistently meet the reporting requirements of the test method, indicating that a common reporting template is required to improve data quality. The most difficult problem encountered was the petrographic distinction of solid bitumens and low-reflecting inert macerals from vitrinite when vitrinite occurred with reflectance ranges overlapping

  17. A counterfactual p-value approach for benefit-risk assessment in clinical trials.

    Science.gov (United States)

    Zeng, Donglin; Chen, Ming-Hui; Ibrahim, Joseph G; Wei, Rachel; Ding, Beiying; Ke, Chunlei; Jiang, Qi

    2015-01-01

    Clinical trials generally allow various efficacy and safety outcomes to be collected for health interventions. Benefit-risk assessment is an important issue when evaluating a new drug. Currently, there is a lack of standardized and validated benefit-risk assessment approaches in drug development due to various challenges. To quantify benefits and risks, we propose a counterfactual p-value (CP) approach. Our approach considers a spectrum of weights for weighting benefit-risk values and computes the extreme probabilities of observing the weighted benefit-risk value in one treatment group as if patients were treated in the other treatment group. The proposed approach is applicable to single benefit and single risk outcome as well as multiple benefit and risk outcomes assessment. In addition, the prior information in the weight schemes relevant to the importance of outcomes can be incorporated in the approach. The proposed CPs plot is intuitive with a visualized weight pattern. The average area under CP and preferred probability over time are used for overall treatment comparison and a bootstrap approach is applied for statistical inference. We assess the proposed approach using simulated data with multiple efficacy and safety endpoints and compare its performance with a stochastic multi-criteria acceptability analysis approach.

  18. Outcomes assessment in the SPRINT multicenter tibial fracture trial: Adjudication committee size has trivial effect on trial results

    NARCIS (Netherlands)

    Simunovic, Nicole; Walter, Stephen; Devereaux, P. J.; Sprague, Sheila; Guyatt, Gordon H.; Schemitsch, Emil; Tornetta, Paul; Sanders, David; Swiontkowski, Marc; Bhandari, Mohit; Guyatt, Gordon; Sanders, David W.; Schemitsch, Emil H.; Heels-Ansdell, Diane; Buckingham, Lisa; Leece, Pamela; Viveiros, Helena; Mignott, Tashay; Ansell, Natalie; Sidorkewicz, Natalie; Agel, Julie; Bombardier, Claire; Berlin, Jesse A.; Bosse, Michael; Browner, Bruce; Gillespie, Brenda; O'Brien, Peter; Poolman, Rudolf; Macleod, Mark D.; Carey, Timothy; Leitch, Kellie; Bailey, Stuart; Gurr, Kevin; Konito, Ken; Bartha, Charlene; Low, Isolina; MacBean, Leila V.; Ramu, Mala; Reiber, Susan; Strapp, Ruth; Tieszer, Christina; Kreder, Hans; Stephen, David J. G.; Axelrod, Terry S.; Yee, Albert J. M.; Richards, Robin R.; Finkelstein, Joel; Holtby, Richard M.; Cameron, Hugh; Cameron, John; Gofton, Wade; Murnaghan, John; Schatztker, Joseph; Bulmer, Beverly; Conlan, Lisa; Laflamme, Yves; Berry, Gregory; Beaumont, Pierre; Ranger, Pierre; Laflamme, Georges-Henri; Jodoin, Alain; Renaud, Eric; Gagnon, Sylvain; Maurais, Gilles; Malo, Michel; Fernandes, Julio; Latendresse, Kim; Poirier, Marie-France; Daigneault, Gina; McKee, Michael M.; Waddell, James P.; Bogoch, Earl R.; Daniels, Timothy R.; McBroom, Robert R.; Vicente, Milena R.; Storey, Wendy; Wild, Lisa M.; McCormack, Robert; Perey, Bertrand; Goetz, Thomas J.; Pate, Graham; Penner, Murray J.; Panagiotopoulos, Kostas; Pirani, Shafique; Dommisse, Ian G.; Loomer, Richard L.; Stone, Trevor; Moon, Karyn; Zomar, Mauri; Webb, Lawrence X.; Teasdall, Robert D.; Birkedal, John Peter; Martin, David Franklin; Ruch, David S.; Kilgus, Douglas J.; Pollock, David C.; Harris, Mitchel Brion; Wiesler, Ethan Ron; Ward, William G.; Shilt, Jeffrey Scott; Koman, Andrew L.; Poehling, Gary G.; Kulp, Brenda; Creevy, William R.; Stein, Andrew B.; Bono, Christopher T.; Einhorn, Thomas A.; Desmond Brown, T.; Pacicca, Donna; Sledge, John B.; Foster, Timothy E.; Voloshin, Ilva; Bolton, Jill; Carlisle, Hope; Shaughnessy, Lisa; Ombremsky, William T.; LeCroy, C. Michael; Meinberg, Eric G.; Messer, Terry M.; Craig, William L.; Dirschl, Douglas R.; Caudle, Robert; Harris, Tim; Elhert, Kurt; Hage, William; Jones, Robert; Piedrahita, Luis; Schricker, Paul O.; Driver, Robin; Godwin, Jean; Hansley, Gloria; Obremskey, William Todd; Kregor, Philip James; Tennent, Gregory; Truchan, Lisa M.; Sciadini, Marcus; Shuler, Franklin D.; Driver, Robin E.; Nading, Mary Alice; Neiderstadt, Jacky; Vap, Alexander R.; Vallier, Heather A.; Patterson, Brendan M.; Wilber, John H.; Wilber, Roger G.; Sontich, John K.; Moore, Timothy Alan; Brady, Drew; Cooperman, Daniel R.; Davis, John A.; Cureton, Beth Ann; Health, Hamilton; Mandel, Scott; Orr, R. Douglas; Sadler, John T. S.; Hussain, Tousief; Rajaratnam, Krishan; Petrisor, Bradley; Drew, Brian; Bednar, Drew A.; Kwok, Desmond C. H.; Pettit, Shirley; Hancock, Jill; Cole, Peter A.; Smith, Joel J.; Brown, Gregory A.; Lange, Thomas A.; Stark, John G.; Levy, Bruce; Swiontkowski, Marc F.; Garaghty, Mary J.; Salzman, Joshua G.; Schutte, Carol A.; Tastad, Linda Toddie; Vang, Sandy; Seligson, David; Roberts, Craig S.; Malkani, Arthur L.; Sanders, Laura; Gregory, Sharon Allen; Dyer, Carmen; Heinsen, Jessica; Smith, Langan; Madanagopal, Sudhakar; Coupe, Kevin J.; Tucker, Jeffrey J.; Criswell, Allen R.; Buckle, Rosemary; Rechter, Alan Jeffrey; Sheth, Dhiren Shaskikant; Urquart, Brad; Trotscher, Thea; Anders, Mark J.; Kowalski, Joseph M.; Fineberg, Marc S.; Bone, Lawrence B.; Phillips, Matthew J.; Rohrbacher, Bernard; Stegemann, Philip; Mihalko, William M.; Buyea, Cathy; Augustine, Stephen J.; Jackson, William Thomas; Solis, Gregory; Ero, Sunday U.; Segina, Daniel N.; Berrey, Hudson B.; Agnew, Samuel G.; Fitzpatrick, Michael; Campbell, Lakina C.; Derting, Lynn; McAdams, June; Goslings, J. Carel; Ponsen, Kees Jan; Luitse, Jan; Kloen, Peter; Joosse, Pieter; Winkelhagen, Jasper; Duivenvoorden, Raphaël; Teague, David C.; Davey, Joseph; Sullivan, J. Andy; Ertl, William J. J.; Puckett, Timothy A.; Pasque, Charles B.; Tompkins, John F.; Gruel, Curtis R.; Kammerlocher, Paul; Lehman, Thomas P.; Puffinbarger, William R.; Carl, Kathy L.; Weber, Donald W.; Jomha, Nadr M.; Goplen, Gordon R.; Masson, Edward; Beaupre, Lauren A.; Greaves, Karen E.; Schaump, Lori N.; Jeray, Kyle J.; Goetz, David R.; Westberry, Davd E.; Broderick, J. Scott; Moon, Bryan S.; Tanner, Stephanie L.; Powell, James N.; Buckley, Richard E.; Elves, Leslie; Connolly, Stephen; Abraham, Edward P.; Eastwood, Donna; Steele, Trudy; Ellis, Thomas; Herzberg, Alex; Brown, George A.; Crawford, Dennis E.; Hart, Robert; Hayden, James; Orfaly, Robert M.; Vigland, Theodore; Vivekaraj, Maharani; Bundy, Gina L.; Miclau, Theodore; Matityahu, Amir; Coughlin, R. Richard; Kandemir, Utku; McClellan, R. Trigg; Hsin, Cindy; Lin, Hua; Karges, David; Cramer, Kathryn; Watson, J. Tracy; Moed, Berton; Scott, Barbara; Beck, Dennis J.; Orth, Carolyn; Puskas, David; Clark, Russell; Jones, Jennifer; Egol, Kenneth A.; Paksima, Nader; France, Monet; Wai, Eugene K.; Johnson, Garth; Wilkinson, Ross; Gruszczynski, Adam T.; Vexler, Liisa

    2011-01-01

    To evaluate how the size of an outcome adjudication committee, and the potential for dominance among its members, potentially impacts a trial's results. We conducted a retrospective analysis of data from the six-member adjudication committee in the Study to Prospectively Evaluate Reamed

  19. Dynamic contrast enhanced ultrasound assessment of the vascular effects of novel therapeutics in early stage trials.

    Science.gov (United States)

    Leen, Edward; Averkiou, Michalakis; Arditi, Marcel; Burns, Peter; Bokor, Daniela; Gauthier, Thomas; Kono, Yuko; Lucidarme, Olivier

    2012-07-01

    Imaging is key in the accurate monitoring of response to cancer therapies targeting tumour vascularity to inhibit its growth and dissemination. Dynamic contrast enhanced ultrasound (DCE ultrasound) is a quantitative method with the advantage of being non-invasive, widely available, portable, cost effective, highly sensitive and reproducible using agents that are truly intravascular. Under the auspices of the initiative of the Experimental Cancer Medicine Centre Imaging Network, bringing together experts from the UK, Europe and North America for a 2-day workshop in May 2010, this consensus paper aims to provide guidance on the use of DCE ultrasound in the measurement of tumour vascular support in clinical trials. Key Points • DCE ultrasound can quantify and extract specific blood flow parameters, such as flow velocity, relative vascular volume and relative blood flow rate. • DCE ultrasound can be performed repeatedly and is therefore ideally suited for pharmacokinetic and pharmacodynamic studies evaluating vascular-targeted drugs. • DCE ultrasound provides a reproducible method of assessing the vascular effects of therapy in pre-clinical and early clinical trials, which is easily translatable into routine clinical practice.

  20. Assessing methods for dealing with treatment switching in randomised controlled trials: a simulation study

    Directory of Open Access Journals (Sweden)

    Latimer Nicholas

    2011-01-01

    Full Text Available Abstract Background We investigate methods used to analyse the results of clinical trials with survival outcomes in which some patients switch from their allocated treatment to another trial treatment. These included simple methods which are commonly used in medical literature and may be subject to selection bias if patients switching are not typical of the population as a whole. Methods which attempt to adjust the estimated treatment effect, either through adjustment to the hazard ratio or via accelerated failure time models, were also considered. A simulation study was conducted to assess the performance of each method in a number of different scenarios. Results 16 different scenarios were identified which differed by the proportion of patients switching, underlying prognosis of switchers and the size of true treatment effect. 1000 datasets were simulated for each of these and all methods applied. Selection bias was observed in simple methods when the difference in survival between switchers and non-switchers were large. A number of methods, particularly the AFT method of Branson and Whitehead were found to give less biased estimates of the true treatment effect in these situations. Conclusions Simple methods are often not appropriate to deal with treatment switching. Alternative approaches such as the Branson & Whitehead method to adjust for switching should be considered.

  1. Seven years of gamma-ray spectrometry interlaboratory comparisons in Switzerland

    International Nuclear Information System (INIS)

    Bailat, Claude; Buchillier, Thierry; Caffari, Yvan; Nedjadi, Youcef; Spring, Philippe; Estier, Sybille; Bochud, Francois

    2010-01-01

    Since the 1990s, regular comparisons of gamma-ray spectrometry in Switzerland were organized to improve laboratory abilities to measure the radioactivity in the environment and food stuffs at typical routine levels. The activity concentration of the test samples and the evaluation of the associated uncertainties remained each year the main required test result. Over the years, the comparisons used certified reference solutions as well as environmental samples. The aim of this study is to research the effect of the comparisons on measurement quality. An analysis of the seven last interlaboratory comparisons revealed that the Swiss measurement capability is up to date. In addition, the results showed that the participants now have an improved evaluation of the uncertainties associated with their measurement.

  2. Interlaboratory beta source calibration using TL and OSL on natural quartz

    DEFF Research Database (Denmark)

    Goksu. H.Y.; Bailiff, I.K.; Bøtter-Jensen, L.

    1995-01-01

    Laboratories using luminescence methods for dose reconstruction have to make interlaboratory source calibrations-initially this will be a single isotope beta or gamma source using one particular reference material. The procedure requires not only the administration of exact doses to the material...... difficulties finding sufficient suitable quartz. Five different batches were obtained from the Merck company and tested for sensitivity, linearity and stability of the 340 degrees C peak, the 1992 batch was found to be the most appropriate. The irradiations were performed at the Secondary Standard Dosimetry...... Laboratory at GSF using a Go-60 source as well as the in situ measurements with an ionization chamber, calibrated to the primary standards of PTB Braunschweig. Irradiated and unirradiated quartz was distributed to the five laboratories and although different procedures were used for thermoluminescence...

  3. NIWR Interlaboratory comparison study No. 80/C: Determination of trace metals in sewage sludge

    International Nuclear Information System (INIS)

    Smith, R.

    1981-01-01

    This study forms part of the NIWR's series of interlaboratory comparison studies involving Southern African laboratories engaged in water and wastewater analysis, and is concerned with the analysis by 20 laboratories of two samples of dried sewage sludge for aluminium, cadmium, chromium, copper, iron, lead, manganese, nickel and zinc. The results obtained are evaluated and discussed, along with some of the advantages and disadvantages of various sample pretreatment techniques. The mean values of the results obtained using the U.S. EPA's recommended sample pretreatment procedure were found to be in good agreement with those obtained using a wide variety of other sample pretreatment techniques, with the exception of those for aluminium. More drastic pretreatment, in the form of fusion or a more vigorous digestion procedure, is advisable for complete extraction of this metal. Most of the laboratories employed flame atomic absorption spectrophotometry for the analyses. The use of suitable interference suppressants and, in certain cases, background correction, was recommended with this method

  4. CIRP Interlaboratory Comparison of Coordinate Measuring Machines using an Optomechanical Hole Plate - Final Report

    DEFF Research Database (Denmark)

    De Chiffre, Leonardo; Hansen, Hans Nørgaard; Morace, Renata Erica

    2005-01-01

    An interlaboratory comparison on mechanical and optical coordinate measuring machines (CMMs) was organized by the Centre for Geometrical Metrology (CGM), Department of Manufacturing Engineering and Management (IPL), Technical University of Denmark (DTU) and carried out within Collège International...... the reversal method with traceability achieved by a comparator measurement. Using the optomechanical hole plate, the measurement procedure can be carried out on optical as well as mechanical measuring machines. Circulation started in March 2003, and was completed in September 2003, whit three optomechanical...... be divided in two groups. A group leading to deviations larger than 2 µm, and a group with deviations that are comparable to those using mechanical machines. All but one laboratory could perform reversal measurements. Transfer of traceability was established as follows: 8 using gauge blocks, 2 laser...

  5. Participation in the 2001 IAEA interlaboratory comparison on geothermal water chemistry

    Energy Technology Data Exchange (ETDEWEB)

    Joe, Kih Soo; Choi, Kwang Soon; Han, Sun Ho; Suh, Moo Yul; Jeon, Young Shin; Choi, Ke Chun; Pyo, Hyung Yul; Kim, Yong Bok; Kim, Jong Gu; Kim, Won Ho [Korea Atomic Energy Research Institute, Taejeon (Korea)

    2002-04-01

    Korea Atomic Energy Research Institute Analytical laboratory participated in the 2001 IAEA Interlaboratory Comparison on chemical analysis of Geothermal Water containing high salinity organized by IAEA Hydrology Laboratory(INT/0/060). 14 items such as pH, electroconductivity, HCO{sub 3}, Cl, F, SO{sub 4}, SiO{sub 2}, B, Li, Na, K, Ca, Mg were analyzed. The result of this program showed that Korea Atomic Energy Research Institute laboratory was ranked within 15% range from top level. Major analytical methods were applied for this activity such as ICP-AES, AAS, IC, pH meter, conductometer and acid titration. 8 refs., 48 figs., 9 tabs. (Author)

  6. CIRP Interlaboratory Comparison of Coordinate Measuring Machines using an Optomechanical Hole Plate

    DEFF Research Database (Denmark)

    De Chiffre, Leonardo; Hansen, Hans Nørgaard; Morace, Renata Erica

    An interlaboratory comparison on mechanical and optical coordinate measuring machines (CMMs) has been organized by the Centre for Geometrical Metrology (CGM), Department of Manufacturing Engineering and Management (IPL), Technical University of Denmark (DTU) and carried out within Collège...... plate [1], designed and manufactured by DTU. A measurement procedure was sent to each participant together with the hole plate to be measured. The procedure consists mainly of two parts [2]: 1) four reversal measurements, by which the systematic errors in the measuring plane (X,Y) on the CMM...... are eliminated, except the positioning errors; 2) transfer of traceability by comparator measurement using a length reference chosen by the participant, by which the positioning errors are eliminated. Furthermore, a third optional part could be carried out by the participant, using a different measurement...

  7. Assessing differential attrition in clinical trials: self-monitoring of oral anticoagulation and type II diabetes

    Directory of Open Access Journals (Sweden)

    Fitzmaurice David

    2007-05-01

    Full Text Available Abstract Background Analyzing drop out rates and when they occur may give important information about the patient characteristics and trial characteristics that affect the overall uptake of an intervention. Methods We searched Medline and the Cochrane library from the beginning of the databases to May 2006 for published systematic reviews that compared the effects of self-monitoring (self-testing or self-management (self-testing and self-dosage of oral anticoagulation or self-monitored blood glucose in type 2 diabetics who were not using insulin. We assessed all study withdrawals pre-randomization and post randomization and sought information on the reasons for discontinuation of all participants. To measure the differential between groups in attrition we used the relative attrition (RA, which is equivalent to relative risk but uses attrition as the outcome (i.e. attrition in intervention group/attrition in control group. We determined the percentage drop outs for control and intervention groups and used DerSimonian and Laird random effects models to estimate a pooled relative attrition. L'abbe type plots created in R (version 2.0.2 were used to represent the difference in the relative attrition among the trials with 95% confidence areas and weights derived from the random effects model. Results With self-monitoring of blood glucose in type 2 diabetes, attrition ranged from 2.3% to 50.0% in the intervention groups and 0% to 40.4% in the control groups. There was no significant difference between the intervention and control, with an overall RA of 1.18 [95% CI, 0.70–2.01]. With self-monitoring of oral anticoagulation attrition ranged from 0% to 43.2% in the intervention groups and 0% to 21.4% in the control group. The RA was significantly greater in the intervention group, combined RA, 6.05 [95% CI, 2.53–14.49]. Conclusion This paper demonstrates the use of relative attrition as a new tool in systematic review methodology which has the

  8. Quality assessment of digital annotated ECG data from clinical trials by the FDA ECG Warehouse.

    Science.gov (United States)

    Sarapa, Nenad

    2007-09-01

    The FDA mandates that digital electrocardiograms (ECGs) from 'thorough' QTc trials be submitted into the ECG Warehouse in Health Level 7 extended markup language format with annotated onset and offset points of waveforms. The FDA did not disclose the exact Warehouse metrics and minimal acceptable quality standards. The author describes the Warehouse scoring algorithms and metrics used by FDA, points out ways to improve FDA review and suggests Warehouse benefits for pharmaceutical sponsors. The Warehouse ranks individual ECGs according to their score for each quality metric and produces histogram distributions with Warehouse-specific thresholds that identify ECGs of questionable quality. Automatic Warehouse algorithms assess the quality of QT annotation and duration of manual QT measurement by the central ECG laboratory.

  9. A Methodology for Equitable Performance Assessment and Presentation of Wave Energy Converters Based on Sea Trials

    DEFF Research Database (Denmark)

    Kofoed, Jens Peter; Pecher, Arthur; Margheritini, Lucia

    2013-01-01

    This paper provides a methodology for the analysis and presentation of data obtained from sea trials of wave energy converters (WEC). The equitable aspect of this methodology lies in its wide application, as any WEC at any scale or stage of development can be considered as long as the tests...... of incomplete data sets. This methodology presents a way to assess the performance of a WEC, being tested in real sea conditions, by evaluating its performance (in a first approach) separately for different wave conditions. These “different wave conditions“ are defined as zones and the range...... to the bi‐variate Hm0‐Te scatter diagram, the influence of other environmental parameters are still expected to be present in the representation of the performance by the inclusion of different data points for every sea state. The extent to which other environmental parameters or even device dependent...

  10. Assessment of data quality in an international multi-centre randomised trial of coronary artery surgery

    Directory of Open Access Journals (Sweden)

    Bochenek Andrzej

    2011-09-01

    Full Text Available Abstract Background ART is a multi-centre randomised trial of cardiac surgery which provided a unique opportunity to evaluate the data from a large number of centres from a variety of countries. We attempted to assess data quality, including recruitment rates, timeliness and completeness of the data obtained from the centres in different socio-economic strata. Methods The analysis was based on the 2-page CRF completed at the 6 week follow-up. CRF pages were categorised into "clean" (no edit query and "dirty" (any incomplete, inconsistent or illegible data. The timelines were assessed on the basis of the time interval from the visit and receipt of complete CRF. Data quality was defined as the number of data queries (in percent and time delay (in days between visit and receipt of correct data. Analyses were stratified according to the World Bank definitions into: "Developing" countries (Poland, Brazil and India and "Developed" (Italy, UK, Austria and Australia. Results There were 18 centres in the "Developed" and 10 centres in the "Developing" countries. The rate of enrolment did not differ significantly by economic level ("Developing":4.1 persons/month, "Developed":3.7 persons/month. The time interval for the receipt of data was longer for "Developing" countries (median:37 days compared to "Developed" ones (median:11 days (p Conclusions In this study we showed that data quality was comparable between centres from "Developed" and "Developing" countries. Data was received in a less timely fashion from Developing countries and appropriate systems should be instigated to minimize any delays. Close attention should be paid to the training of centres and to the central management of data quality. Trial registration ISRCTN46552265

  11. Assessing the quality of reports of randomized trials in pediatric complementary and alternative medicine

    Directory of Open Access Journals (Sweden)

    Lepage Leah

    2002-02-01

    Full Text Available Abstract Objective To evaluate the quality of reports of complementary and alternative medicine (CAM randomized controlled trials (RCTs in the pediatric population. We also examined whether there was a change in the quality of reporting over time. Methods We used a systematic sample of 251 reports of RCTs that used a CAM intervention. The quality of each report was assessed using the number of CONSORT checklist items included, the frequency of unclear allocation concealment, and a 5-point quality assessment instrument. Results Nearly half (40% of the CONSORT checklist items were included in the reports, with an increase in the number of items included. The majority (81.3% of RCTs reported unclear allocation concealment with no significant change over time. The quality of reports achieved approximately 40% of their maximum possible total score as assessed with the Jadad scale with no change over time. Information regarding adverse events was reported in less than one quarter of the RCTs (22% and information regarding costs was mentioned in only a minority of reports (4%. Conclusions RCTs are an important tool for evidence based health care decisions. If these studies are to be relevant in the evaluation of CAM interventions it is important that they are conducted and reported with the highest possible standards. There is a need to redouble efforts to ensure that children and their families are participating in RCTs that are conducted and reported with minimal bias. Such studies will increase their usefulness to a board spectrum of interested stakeholders.

  12. Assessing sample representativeness in randomized controlled trials: application to the National Institute of Drug Abuse Clinical Trials Network.

    Science.gov (United States)

    Susukida, Ryoko; Crum, Rosa M; Stuart, Elizabeth A; Ebnesajjad, Cyrus; Mojtabai, Ramin

    2016-07-01

    To compare the characteristics of individuals participating in randomized controlled trials (RCTs) of treatments of substance use disorder (SUD) with individuals receiving treatment in usual care settings, and to provide a summary quantitative measure of differences between characteristics of these two groups of individuals using propensity score methods. Design Analyses using data from RCT samples from the National Institute of Drug Abuse Clinical Trials Network (CTN) and target populations of patients drawn from the Treatment Episodes Data Set-Admissions (TEDS-A). Settings Multiple clinical trial sites and nation-wide usual SUD treatment settings in the United States. A total of 3592 individuals from 10 CTN samples and 1 602 226 individuals selected from TEDS-A between 2001 and 2009. Measurements The propensity scores for enrolling in the RCTs were computed based on the following nine observable characteristics: sex, race/ethnicity, age, education, employment status, marital status, admission to treatment through criminal justice, intravenous drug use and the number of prior treatments. Findings The proportion of those with ≥ 12 years of education and the proportion of those who had full-time jobs were significantly higher among RCT samples than among target populations (in seven and nine trials, respectively, at P difference in the mean propensity scores between the RCTs and the target population was 1.54 standard deviations and was statistically significant at P different from individuals receiving treatment in usual care settings. Notably, RCT participants tend to have more years of education and a greater likelihood of full-time work compared with people receiving care in usual care settings. © 2016 Society for the Study of Addiction.

  13. Practical aspects of conducting a pragmatic randomised trial in primary care: patient recruitment and outcome assessment

    NARCIS (Netherlands)

    D.A.W.M. van der Windt (Daniëlle); B.W. Koes (Bart); M. van Aarst; M.A. Heemskerk; L.M. Bouter (Lex)

    2000-01-01

    textabstractBACKGROUND: Conducting a pragmatic randomised trial in primary care is often accompanied by practical problems. Such problems are seldom reported and may constitute useful lessons for researchers planning future trials. AIM: To address the difficulties

  14. Alcohol email assessment and feedback study dismantling effectiveness for university students (AMADEUS-1: study protocol for a randomized controlled trial

    Directory of Open Access Journals (Sweden)

    McCambridge Jim

    2012-07-01

    Full Text Available Abstract Background Alcohol causes huge problems for population health and for society, which require interventions with individuals as well as populations to prevent and reduce harms. Brief interventions can be effective and increasingly take advantage of the internet to reach high-risk groups such as students. The research literature on the effectiveness of online interventions is developing rapidly and is confronted by methodological challenges common to other areas of e-health including attrition and assessment reactivity and in the design of control conditions. Methods/design The study aim is to evaluate the effectiveness of a brief online intervention, employing a randomized controlled trial (RCT design that takes account of baseline assessment reactivity, and other possible effects of the research process. Outcomes will be evaluated after 3 months both among student populations as a whole including for a randomized no contact control group and among those who are risky drinkers randomized to brief assessment and feedback (routine practice or to brief assessment only. A three-arm parallel groups trial will also allow exploration of the magnitude of the feedback and assessment component effects. The trial will be undertaken simultaneously in 2 universities randomizing approximately 15,300 students who will all be blinded to trial participation. All participants will be offered routine practice intervention at the end of the study. Discussion This trial informs the development of routine service delivery in Swedish universities and more broadly contributes a new approach to the study of the effectiveness of online interventions in student populations, with relevance to behaviors other than alcohol consumption. The use of blinding and deception in this study raise ethical issues that warrant further attention. Trial registration ISRCTN28328154

  15. [Pragmatic randomized controlled trials as a source of data in the assessment of effectiveness of medical technology].

    Science.gov (United States)

    Kaczyński, Lukasz; Solnica, Bogdan

    2012-01-01

    Acquisition of scientific data needed to make rational decisions about health policy has became an important tool in determining the validity of the financing methods of treatment from public funds under the health technology assessment (HTA). The primary source of scientific evidence for health technology assessment are randomized controlled trials (RCTs, explanatory trials evaluating the efficacy), because of their features reducing methodological bias (e.g. randomization or blindness). These features may become a disadvantage, which seriously reduces the possibility of transfer of the results and conclusions to the level of routine practice. In this situation an important role begin to play studies that provide data on effectiveness-observational studies, registries and pragmatic randomized controlled trials (pRCTs).

  16. Randomised placebo controlled multicentre trial to assess short term clarithromycin for patients with stable coronary heart disease: CLARICOR trial

    DEFF Research Database (Denmark)

    Jespersen, Christian M; Als-Nielsen, Bodil; Damgaard, Morten

    2005-01-01

    OBJECTIVE: To determine if the macrolide clarithromycin affects mortality and cardiovascular morbidity in patients with stable coronary heart disease. DESIGN: Centrally randomised multicentre trial. All parties at all stages were blinded. Analyses were by intention to treat. SETTING: Five...... Copenhagen University cardiology departments and a coordinating centre. PARTICIPANTS: 13,702 patients aged 18 to 85 years who had a discharge diagnosis of myocardial infarction or angina pectoris in 1993-9 and alive in August 1999 were invited by letter; 4373 were randomised. INTERVENTIONS: Two weeks...

  17. Randomised placebo controlled multicentre trial to assess short term clarithromycin for patients with stable coronary heart disease: CLARICOR trial

    DEFF Research Database (Denmark)

    Jespersen, CM; Als-Nielsen, B; Damgaard, M

    2006-01-01

    OBJECTIVE: To determine if the macrolide clarithromycin affects mortality and cardiovascular morbidity in patients with stable coronary heart disease. DESIGN: Centrally randomised multicentre trial. All parties at all stages were blinded. Analyses were by intention to treat. SETTING: Five...... Copenhagen University cardiology departments and a coordinating centre. PARTICIPANTS: 13,702 patients aged 18 to 85 years who had a discharge diagnosis of myocardial infarction or angina pectoris in 1993-9 and alive in August 1999 were invited by letter; 4373 were randomised. INTERVENTIONS: Two weeks...

  18. Randomized Clinical Trial Design to Assess Abatacept in Resistant Nephrotic Syndrome.

    Science.gov (United States)

    Trachtman, Howard; Gipson, Debbie S; Somers, Michael; Spino, Cathie; Adler, Sharon; Holzman, Lawrence; Kopp, Jeffrey B; Sedor, John; Overfield, Sandra; Elegbe, Ayanbola; Maldonado, Michael; Greka, Anna

    2018-01-01

    Treatment-resistant nephrotic syndrome is a rare form of glomerular disease that occurs in children and adults. No Food and Drug Administration-approved treatments consistently achieve remission of proteinuria and preservation of kidney function. CD80 (B7-1) can be expressed on injured podocytes, and administration of abatacept (modified CTLA4-Ig based on a natural ligand to CD80) has been associated with sustained normalization of urinary protein excretion and maintenance of glomerular filtration rate in experimental and clinical settings. In this report, we describe the rationale for and design of a randomized, placebo-controlled, clinical trial of abatacept in patients with treatment-resistant nephrotic syndrome caused by focal segmental glomerulosclerosis or minimal change disease. The design is a hybrid of a parallel-group and crossover design (switchover) with the primary objectives assessed in the first period of the study and the secondary objectives assessed using data from both periods. All participants will receive the active agent in 1 of the periods. The duration of treatment will be 4 months per period. The primary outcome will be improvement in nephrotic-range proteinuria to subnephrotic range, that is, reduction from baseline to 4 months in urine protein:creatinine ratio ≥ 50% and to a level precision medicine-based approach to this serious kidney condition in which the selection of a therapeutic agent is guided by the underlying disease mechanism operating in individual patients.

  19. Feasibility of assessing quality of care at the end of life in two cluster trials using an after-death approach with multiple assessments

    NARCIS (Netherlands)

    West, E.; Romoli, V.; Di Leo, S.; Higginson, I.J.; Miccinesi, G.; Costantini, M.

    2014-01-01

    Background: In 2009 two randomised cluster trials took place to assess the introduction of the Italian Version of the Liverpool Care Pathway in hospitals and hospices. Before and after data were gathered. The primary aim of this study is to evaluate the feasibility of using a combination of

  20. Assessing the quality of randomized controlled trials from two leading cancer journals using the CONSORT statement.

    Science.gov (United States)

    Süt, Necdet; Senocak, Mustafa; Uysal, Omer; Köksalan, Hilal

    2008-01-01

    No study has been conducted on the scientific quality of randomized controlled trials (RCTs) in the cancer field. Our objective was to determine whether adherence to the Consolidated Standards for Reporting Trials (CONSORT) statement is associated with scientific properties of RCT reports from two leading cancer journals. We conducted an observational study of RCTs published between 2002 and 2004 in two leading cancer journals that did not endorse the CONSORT statement during that period. We determined the adherence rates with confidence intervals of 33 RCTs according to the 19 methodological items of the CONSORT statement. Each RCT was blindly assessed by three independent evaluators; then the evaluators examined all judgments sequentially and obtained a consensus regarding each methodological item of the CONSORT statement. The average adherence of these 33 RCTs to the 19 methodological items of the CONSORT statement was 79.3% (95% CI, 75.3-83.4%). Most descriptors from the checklist were determined to be methodologically adequate except sequence generation (56.1%; 95% CI, 40.9-71.3%), allocation concealment (27.3%; 95% CI, 13.2-41.4%), implementation (7.6%; 95% CI, 0.0-15.4%), blinding (30.3%; 95% CI, 14.4-46.3%) and sample size (74.2%; 95% CI, 59.5-89.0%). Of all CONSORT checklist items, randomization implementation was the most often omitted. Some key methodological items of the CONSORT statement seem poorly addressed in RCTs from these leading cancer journals. Thus researchers should be urged to conform to the CONSORT statement when reporting on RCTs, and the poorly addressed items of the CONSORT statement should be reevaluated for RCTs already reported.

  1. Assessing methods for dealing with treatment switching in clinical trials: A follow-up simulation study.

    Science.gov (United States)

    Latimer, Nicholas R; Abrams, Keith R; Lambert, Paul C; Morden, James P; Crowther, Michael J

    2018-03-01

    When patients randomised to the control group of a randomised controlled trial are allowed to switch onto the experimental treatment, intention-to-treat analyses of the treatment effect are confounded because the separation of randomised groups is lost. Previous research has investigated statistical methods that aim to estimate the treatment effect that would have been observed had this treatment switching not occurred and has demonstrated their performance in a limited set of scenarios. Here, we investigate these methods in a new range of realistic scenarios, allowing conclusions to be made based upon a broader evidence base. We simulated randomised controlled trials incorporating prognosis-related treatment switching and investigated the impact of sample size, reduced switching proportions, disease severity, and alternative data-generating models on the performance of adjustment methods, assessed through a comparison of bias, mean squared error, and coverage, related to the estimation of true restricted mean survival in the absence of switching in the control group. Rank preserving structural failure time models, inverse probability of censoring weights, and two-stage methods consistently produced less bias than the intention-to-treat analysis. The switching proportion was confirmed to be a key determinant of bias: sample size and censoring proportion were relatively less important. It is critical to determine the size of the treatment effect in terms of an acceleration factor (rather than a hazard ratio) to provide information on the likely bias associated with rank-preserving structural failure time model adjustments. In general, inverse probability of censoring weight methods are more volatile than other adjustment methods.

  2. Observer variability in a phase II trial. Assessing consistency in RECIST application

    International Nuclear Information System (INIS)

    Skougaard, Kristin; Nielsen, Dorte; Vittrup Jensen, Benny; Dusgaard McCullagh, Mark James; Hjorth Johannesen, Helle; Westergren Hendel, Helle

    2012-01-01

    Objective: To assess the consistency of Response Evaluation Criteria in Solid Tumours (RECIST) application in a phase II trial. Material and methods: Patients with metastatic non-resectable colorectal cancer treated with a combination of an antibody and a chemotherapeutic drug, were included. Computed tomography (CT) scans (thorax, abdomen and pelvis) were performed at baseline and after every fourth treatment cycle. RECIST was intended for response evaluation. The scans were consecutively read by a heterogeneous group of radiologists as a part of daily work and hereafter retrospectively reviewed by a dedicated experienced radiologist. Agreement on best overall response (BOR) between readers and reviewer was quantified using κ-coefficients and the discrepancy rate was correlated with the number of different readers per patient using a χ 2 -test. Results: One hundred patients with 396 CT scans were included. Discrepancies between the readers and the reviewer were found in 47 patients. The majority of discrepancies concerned the application of RECIST. With the review, BOR changed in 17 patients, although, only in six patients the change was potentially treatment altering. Overall, the κ-coefficient of agreement between readers and reviewer was 0.71 (good). However, in the subgroup of responding patients the κ-coefficient was 0.21 (fair). The number of patients with discrepancies was significantly higher with three or more different readers per patient than with less (p =0.0003). Conclusion: RECIST was not consistently applied and the majority of the reader discrepancies were RECIST related. Post review, 17 patients changed BOR; six patients in a potentially treatment altering manner. Additionally, we found that the part of patients with discrepancies increased significantly with more than three different readers per patient. The findings support a peer-review approach where a few dedicated radiologists perform double blinded readings of all the on-going cancer

  3. Inter-laboratory comparisons of hexenuronic acid measurements in kraft eucalyptus pulps using a UV-Vis spectroscopic method

    Science.gov (United States)

    J.Y. Zhu; H.F Zhou; Chai X.S.; Donna Johannes; Richard Pope; Cristina Valls; M. Blanca Roncero

    2014-01-01

    An inter-laboratory comparison of a UV-Vis spectroscopic method (TAPPI T 282 om-13 “Hexeneuronic acid content of chemical pulp”) for hexeneuronic acid measurements was conducted using three eucalyptus kraft pulps. The pulp samples were produced in a laboratory at kappa numbers of approximately 14, 20, and 35. The hexeneuronic acid contents of the three pulps were...

  4. Inter-Laboratory Comparison of Luminous Intensity Distribution and Total Luminous Flux Measurements with Far Field and Near Field Goniophotometry

    OpenAIRE

    Acuna, Paula; Quintero, Jesús; Losada, Daniel; Leloup, Frédéric; Hanselaer, Peter

    2014-01-01

    In order to be recognized as a competent testing and calibration laboratory, metrology laboratories who aim to obtain an accreditation for specific tests need to fulfill a number of general requirements as stipulated in the International Standard ISO/IEC17025. One way to assure the quality of testing is to participate in proficiency testing programs or to conduct interlaboratory comparisons. In this paper, luminous intensity distribution measurements of three LED lamps, p...

  5. Safety and nutritional assessment of GM plants and derived food and feed: The role of animal feeding trials

    NARCIS (Netherlands)

    Haver, van E.; Alink, G.M.; Cockburn, A.; Kuiper, H.A.; Peijnenburg, A.A.C.M.

    2008-01-01

    In this report the various elements of the safety and nutritional assessment procedure for genetically modified (GM) plant derived food and feed are discussed, in particular the potential and limitations of animal feeding trials for the safety and nutritional testing of whole GM food and feed. The

  6. A Randomized, Wait-List Controlled Effectiveness Trial Assessing School-Wide Positive Behavior Support in Elementary Schools

    Science.gov (United States)

    Horner, Robert H.; Sugai, George; Smolkowski, Keith; Eber, Lucille; Nakasato, Jean; Todd, Anne W.; Esperanza, Jody

    2009-01-01

    We report a randomized, wait-list controlled trial assessing the effects of school-wide positive behavior support (SWPBS). An effectiveness analysis was conducted with elementary schools in Hawaii and Illinois where training and technical assistance in SWPBS was provided by regular state personnel over a 3-year period. Results document that the…

  7. Systematic pain assessment in nursing homes: a cluster-randomized trial using mixed-methods approach.

    Science.gov (United States)

    Mamhidir, Anna-Greta; Sjölund, Britt-Marie; Fläckman, Birgitta; Wimo, Anders; Sköldunger, Anders; Engström, Maria

    2017-02-28

    Chronic pain affects nursing home residents' daily life. Pain assessment is central to adequate pain management. The overall aim was to investigate effects of a pain management intervention on nursing homes residents and to describe staffs' experiences of the intervention. A cluster-randomized trial and a mixed-methods approach. Randomized nursing home assignment to intervention or comparison group. The intervention group after theoretical and practical training sessions, performed systematic pain assessments using predominately observational scales with external and internal facilitators supporting the implementation. No measures were taken in the comparison group; pain management continued as before, but after the study corresponding training was provided. Resident data were collected baseline and at two follow-ups using validated scales and record reviews. Nurse group interviews were carried out twice. Primary outcome measures were wellbeing and proxy-measured pain. Secondary outcome measures were ADL-dependency and pain documentation. Using both non-parametric statistics on residential level and generalized estimating equation (GEE) models to take clustering effects into account, the results revealed non-significant interaction effects for the primary outcome measures, while for ADL-dependency using Katz-ADL there was a significant interaction effect. Comparison group (n = 66 residents) Katz-ADL values showed increased dependency over time, while the intervention group demonstrated no significant change over time (n = 98). In the intervention group, 13/44 residents showed decreased pain scores over the period, 14/44 had no pain score changes ≥ 30% in either direction measured with Doloplus-2. Furthermore, 17/44 residents showed increased pain scores ≥ 30% over time, indicating pain/risk for pain; 8 identified at the first assessment and 9 were new, i.e. developed pain over time. No significant changes in the use of drugs was found in any of

  8. Inter-laboratory validation of the measurement of follicle stimulating hormone (FSH after various lengths of frozen storage

    Directory of Open Access Journals (Sweden)

    Behr Barry

    2010-11-01

    Full Text Available Abstract Background Serum follicle stimulating hormone (FSH levels are used clinically to evaluate infertility, pituitary and gonadal disorders. With increased frequency of research collaborations across institutions, it is essential that inter-laboratory validation is addressed. Methods An inter-laboratory validation of three commercial FSH immunoassays was performed with human serum samples of varying frozen storage length (2 batches of 15 samples each at -25 degree C. Percentage differences and Bland-Altman limits of agreement were calculated. Results The inter- and intra-laboratory consistency of FSH values with the same assay manufacturer was much higher after shorter-term storage (frozen for less than 11 months, mean percentage degradation less than 4% than after long-term storage (2-3 years, mean percentage degradation = 23%. Comparing assay results from different manufacturers, there was similar overall long term degradation as seen with the same manufacturer (-25%, however the degradation was greater when the original FSH was greater than 20 mIU/mL relative to less than 10 mIU/mL (p Conclusion The findings suggest that degradation of serum samples stored between 11 months and 2-3 years at -25 degrees C can lead to unstable FSH measurements. Inter-laboratory variability due to frozen storage time and manufacturer differences in assay results should be accounted for when designing and implementing research or clinical quality control activities involving serum FSH at multiple study sites.

  9. Evaluating holistic needs assessment in outpatient cancer care—a randomised controlled trial: the study protocol

    Science.gov (United States)

    Snowden, Austyn; Young, Jenny; White, Craig; Murray, Esther; Richard, Claude; Lussier, Marie-Therese; MacArthur, Ewan; Storey, Dawn; Schipani, Stefano; Wheatley, Duncan; McMahon, Jeremy; Ross, Elaine

    2015-01-01

    Introduction People living with and beyond cancer are vulnerable to a number of physical, functional and psychological issues. Undertaking a holistic needs assessment (HNA) is one way to support a structured discussion of patients’ needs within a clinical consultation. However, there is little evidence on how HNA impacts on the dynamics of the clinical consultation. This study aims to establish (1) how HNA affects the type of conversation that goes on during a clinical consultation and (2) how these putative changes impact on shared decision-making and self-efficacy. Methods and analysis The study is hosted by 10 outpatient oncology clinics in the West of Scotland and South West England. Participants are patients with a diagnosis of head and neck, breast, urological, gynaecological and colorectal cancer who have received treatment for their cancer. Patients are randomised to an intervention or control group. The control group entails standard care—routine consultation between the patient and clinician. In the intervention group, the patient completes a holistic needs assessment prior to consultation. The completed assessment is then given to the clinician where it informs a discussion based on the patient's needs and concerns as identified by them. The primary outcome measure is patient participation, as determined by dialogue ratio (DR) and preponderance of initiative (PI) within the consultation. The secondary outcome measures are shared decision-making and self-efficacy. It is hypothesised that HNA will be associated with greater patient participation within the consultation, and that shared decision-making and feelings of self-efficacy will increase as a function of the intervention. Ethics and dissemination This study has been given a favourable opinion by the West of Scotland Research Ethics Committee and NHS Research & Development. Study findings will be disseminated through peer-reviewed publications and conference attendance. Trail registration number

  10. Evaluating holistic needs assessment in outpatient cancer care--a randomised controlled trial: the study protocol.

    Science.gov (United States)

    Snowden, Austyn; Young, Jenny; White, Craig; Murray, Esther; Richard, Claude; Lussier, Marie-Therese; MacArthur, Ewan; Storey, Dawn; Schipani, Stefano; Wheatley, Duncan; McMahon, Jeremy; Ross, Elaine

    2015-05-11

    People living with and beyond cancer are vulnerable to a number of physical, functional and psychological issues. Undertaking a holistic needs assessment (HNA) is one way to support a structured discussion of patients' needs within a clinical consultation. However, there is little evidence on how HNA impacts on the dynamics of the clinical consultation. This study aims to establish (1) how HNA affects the type of conversation that goes on during a clinical consultation and (2) how these putative changes impact on shared decision-making and self-efficacy. The study is hosted by 10 outpatient oncology clinics in the West of Scotland and South West England. Participants are patients with a diagnosis of head and neck, breast, urological, gynaecological and colorectal cancer who have received treatment for their cancer. Patients are randomised to an intervention or control group. The control group entails standard care--routine consultation between the patient and clinician. In the intervention group, the patient completes a holistic needs assessment prior to consultation. The completed assessment is then given to the clinician where it informs a discussion based on the patient's needs and concerns as identified by them. The primary outcome measure is patient participation, as determined by dialogue ratio (DR) and preponderance of initiative (PI) within the consultation. The secondary outcome measures are shared decision-making and self-efficacy. It is hypothesised that HNA will be associated with greater patient participation within the consultation, and that shared decision-making and feelings of self-efficacy will increase as a function of the intervention. This study has been given a favourable opinion by the West of Scotland Research Ethics Committee and NHS Research & Development. Study findings will be disseminated through peer-reviewed publications and conference attendance. Clinical Trials.gov NCT02274701. Published by the BMJ Publishing Group Limited. For

  11. A meta-analysis of clinical trials assessing the effect of radiofrequency ablation for breast cancer

    Directory of Open Access Journals (Sweden)

    Chen J

    2016-03-01

    Full Text Available Jiayan Chen,1,* Chi Zhang,1,* Fei Li,1,* Liping Xu,1 Hongcheng Zhu,1 Shui Wang,2 Xiaoan Liu,2 Xiaoming Zha,2 Qiang Ding,2 Lijun Ling,2 Wenbin Zhou,2 Xinchen Sun1 1Department of Radiation Oncology, 2Department of Breast Surgery, The First Affiliated Hospital, Nanjing Medical University, Nanjing, People’s Republic of China *These authors contributed equally to this work Background: Radiofrequency ablation (RFA is a minimally invasive thermal ablation technique. We conducted a meta-analysis based on eligible studies to assess the efficacy and safety of RFA for treating patients with breast cancer.Methods: A literature search was conducted in PubMed, Embase, and Web of Science databases. Eligible studies were clinical trials that assessed RFA in patients with breast cancer. The outcomes included complete ablation rate, recurrence rate, excellent or good cosmetic rates, and complication rate. A random-effects or fixed-effects model was used to pool the estimate, according to the heterogeneity among the included studies.Results: Fifteen studies, with a total of 404 patients, were included in this meta-analysis. Pooled results showed that 89% (95% confidence interval: 85%–93% of patients achieved a complete ablation after RFA treatment and 96% of patients reported a good-to-excellent cosmetic result. Although the pooled result for recurrence rate was 0, several cases of relapse were observed at different follow-up times. No RFA-related complications were recorded, except for skin burn with an incidence of 4% (95% confidence interval: 1%–6%.Conclusion: This meta-analysis showed that RFA can be a promising alternative option for treating breast cancer since it produces a higher complete ablation rate with a low complication rate. Further well-designed randomized controlled trials are needed to confirm the efficacy and safety of RFA for breast cancer. Keywords: radiofrequency ablation, breast cancer, meta-analysis

  12. Holistic assessment of women with hyperemesis gravidarum: A randomised controlled trial.

    Science.gov (United States)

    Fletcher, S J; Waterman, H; Nelson, L; Carter, L A; Dwyer, L; Roberts, C; Torgerson, D; Kitchener, H

    2015-11-01

    Hyperemesis gravidarum or severe nausea and vomiting of pregnancy affects women's physical, social and psychological wellbeing and often requires frequent hospital admissions. Current standard care may be too medically focussed to meet all of women's complex needs. The aim of this study is to test where using a validated questionnaire, the Hyperemesis Impact of Symptoms tool, delivered by a nurse to assess the overall effect of hyperemesis on an individual woman's life and to provide advice tailored to her specific needs, will help her cope better with her symptoms and reduce admissions to hospital. This study was a two arm randomised controlled trial in which women with hyperemesis from four hospitals were randomly allocated to one of two groups: (1) usual care and (2) usual care plus assessment with the Hyperemesis Impact of Symptoms questionnaire and a care plan tailored to their responses. Recruitment was from women who were admitted with hyperemesis gravidarum; diabetic women or those over 14 weeks gestation were excluded. Those who consented completed questionnaires to assess their quality of life and the severity of symptoms at baseline and at three time points over the following 6 weeks. Women's average social functioning, Hyperemesis Impact of Symptom scores and average number of admissions were not significantly different between either group. The average number of days in hospital for the questionnaire and tailored plan group was significantly lower, 4.97, compared with 6.14 in the usual care group. Using the questionnaire to plan individualised care was not associated with significant reduction in health care costs. Using the Hyperemesis Impact of Symptoms questionnaire to tailor a care plan to address women's individual needs was not associated with any significant improvements in the quality of life. The cost effectiveness analysis did not indicate that the questionnaire is cost saving. The Hyperemesis Impact of Symptoms questionnaire is a practical

  13. Inter-laboratory evaluation of instrument platforms and experimental workflows for quantitative accuracy and reproducibility assessment

    Directory of Open Access Journals (Sweden)

    Andrew J. Percy

    2015-09-01

    Full Text Available The reproducibility of plasma protein quantitation between laboratories and between instrument types was examined in a large-scale international study involving 16 laboratories and 19 LC–MS/MS platforms, using two kits designed to evaluate instrument performance and one kit designed to evaluate the entire bottom-up workflow. There was little effect of instrument type on the quality of the results, demonstrating the robustness of LC/MRM-MS with isotopically labeled standards. Technician skill was a factor, as errors in sample preparation and sub-optimal LC–MS performance were evident. This highlights the importance of proper training and routine quality control before quantitation is done on patient samples.

  14. Concordance between timeline follow-back and single-question assessment of self-reported smoking in a clinical trial.

    Science.gov (United States)

    Bernstein, Steven L; Rosner, June; Toll, Benjamin

    2016-01-01

    Smoking cessation clinical trials assess tobacco abstinence using self-report and biomarkers. Optimum methods for each are unclear; a common question assesses smoking in the prior 7 days. In contrast, timeline follow-back (TLFB) is another technique often used to assess use of alcohol in treatment trials; it is used less frequently in studies of smoking cessation. The goal of this study was to assess concordance between the 7-day smoking question and a 7-day TLFB. Secondary analysis of data from a randomized clinical trial of smoking cessation was conducted at a busy, urban hospital emergency department (ED) from October 2010 to December 2012. At 1, 3, and 12 months, subjects were contacted by phone to assess smoking status. Those reporting abstinence at 3 months were asked to return for an in-person measurement of exhaled carbon monoxide. For this analysis, smoking status at 1 month was compared for subjects in response to 2 questions asked concurrently, addressing 7-day point prevalence tobacco use and a 7-day TLFB. Of 780 subjects, 666 (85.4%) were available for 1-month follow-up. Of these, 99 (14.9%) reported no smoking in response to the 7-day question, and 96 (14.4%) reported no smoking in response to the 7-day TLFB. The overall proportionate agreement between the 2 methods was 98.6%, with a kappa of 0.95 (95% confidence interval [CI]: 0.91-0.98). A single question that assesses smoking at 7 days provides excellent concordance with the more detailed TLFB. The single question appears adequate to assess self-reported tobacco use in clinical trials of smoking cessation.

  15. The OECD validation program of the H295R steroidogenesis assay for the identification of in vitro inhibitors and inducers of testosterone and estradiol production. Phase 2: Inter-laboratory pre-validation studies

    DEFF Research Database (Denmark)

    Hecker, Markus; Hollert, Henner; Cooper, Ralph

    2007-01-01

    are currently ongoing as part of the 'Special Activity on the Testing and Assessment of Endocrine Disruptors' within the OECD Test Guidelines Program to review, develop, standardize, and validate a number of in vitro and in vivo toxicological assays for testing and assessment of chemicals concerning...... plate was run in conjunction with the chemical exposure plate to account for inter-assay variation. Each chemical exposure was conducted two or three times. Results. All laboratories successfully detected increases and/or decreases in hormone production by H295R cells after exposure to the different...... related to one laboratory there were unexplained minor uncertainties related to the inter-laboratory hormone production variation. Based on the findings from this Phase 2 prevalidation study, the H295R Steroidogenesis Assay protocol is currently being refined. The next phase of the OECD validation program...

  16. Interlaboratory study of the ion source memory effect in 36Cl accelerator mass spectrometry

    International Nuclear Information System (INIS)

    Pavetich, Stefan; Akhmadaliev, Shavkat; Arnold, Maurice; Aumaître, Georges; Bourlès, Didier; Buchriegler, Josef; Golser, Robin; Keddadouche, Karim; Martschini, Martin; Merchel, Silke; Rugel, Georg; Steier, Peter

    2014-01-01

    Highlights: • Long-term memory effect in negative ion sources investigated for chlorine isotopes. • Interlaboratory comparison of four up-to date negative ion sources. • Ion source improvement at DREAMS for minimization of long-term memory effect. • Long-term memory effect is the limitation for precise AMS data of volatile elements. • Findings to be considered for samples with highly variable ratios of 36 Cl/Cl and 129 I/I. - Abstract: Understanding and minimization of contaminations in the ion source due to cross-contamination and long-term memory effect is one of the key issues for accurate accelerator mass spectrometry (AMS) measurements of volatile elements. The focus of this work is on the investigation of the long-term memory effect for the volatile element chlorine, and the minimization of this effect in the ion source of the Dresden accelerator mass spectrometry facility (DREAMS). For this purpose, one of the two original HVE ion sources at the DREAMS facility was modified, allowing the use of larger sample holders having individual target apertures. Additionally, a more open geometry was used to improve the vacuum level. To evaluate this improvement in comparison to other up-to-date ion sources, an interlaboratory comparison had been initiated. The long-term memory effect of the four Cs sputter ion sources at DREAMS (two sources: original and modified), ASTER (Accélérateur pour les Sciences de la Terre, Environnement, Risques) and VERA (Vienna Environmental Research Accelerator) had been investigated by measuring samples of natural 35 Cl/ 37 Cl-ratio and samples highly-enriched in 35 Cl ( 35 Cl/ 37 Cl ∼ 999). Besides investigating and comparing the individual levels of long-term memory, recovery time constants could be calculated. The tests show that all four sources suffer from long-term memory, but the modified DREAMS ion source showed the lowest level of contamination. The recovery times of the four ion sources were widely spread between

  17. Interlaboratory study of the ion source memory effect in {sup 36}Cl accelerator mass spectrometry

    Energy Technology Data Exchange (ETDEWEB)

    Pavetich, Stefan, E-mail: s.pavetich@hzdr.de [Helmholtz-Zentrum Dresden-Rossendorf, Bautzner Landstraße 400, 01314 Dresden (Germany); Akhmadaliev, Shavkat [Helmholtz-Zentrum Dresden-Rossendorf, Bautzner Landstraße 400, 01314 Dresden (Germany); Arnold, Maurice; Aumaître, Georges; Bourlès, Didier [Aix-Marseille Université, CEREGE CNRS-IRD, F-13545 Aix-en-Provence (France); Buchriegler, Josef [Helmholtz-Zentrum Dresden-Rossendorf, Bautzner Landstraße 400, 01314 Dresden (Germany); University of Vienna, Faculty of Physics, VERA Laboratory, Währingerstraße 17, 1090 Vienna (Austria); Golser, Robin [University of Vienna, Faculty of Physics, VERA Laboratory, Währingerstraße 17, 1090 Vienna (Austria); Keddadouche, Karim [Aix-Marseille Université, CEREGE CNRS-IRD, F-13545 Aix-en-Provence (France); Martschini, Martin [University of Vienna, Faculty of Physics, VERA Laboratory, Währingerstraße 17, 1090 Vienna (Austria); Merchel, Silke; Rugel, Georg [Helmholtz-Zentrum Dresden-Rossendorf, Bautzner Landstraße 400, 01314 Dresden (Germany); Steier, Peter [University of Vienna, Faculty of Physics, VERA Laboratory, Währingerstraße 17, 1090 Vienna (Austria)

    2014-06-01

    Highlights: • Long-term memory effect in negative ion sources investigated for chlorine isotopes. • Interlaboratory comparison of four up-to date negative ion sources. • Ion source improvement at DREAMS for minimization of long-term memory effect. • Long-term memory effect is the limitation for precise AMS data of volatile elements. • Findings to be considered for samples with highly variable ratios of {sup 36}Cl/Cl and {sup 129}I/I. - Abstract: Understanding and minimization of contaminations in the ion source due to cross-contamination and long-term memory effect is one of the key issues for accurate accelerator mass spectrometry (AMS) measurements of volatile elements. The focus of this work is on the investigation of the long-term memory effect for the volatile element chlorine, and the minimization of this effect in the ion source of the Dresden accelerator mass spectrometry facility (DREAMS). For this purpose, one of the two original HVE ion sources at the DREAMS facility was modified, allowing the use of larger sample holders having individual target apertures. Additionally, a more open geometry was used to improve the vacuum level. To evaluate this improvement in comparison to other up-to-date ion sources, an interlaboratory comparison had been initiated. The long-term memory effect of the four Cs sputter ion sources at DREAMS (two sources: original and modified), ASTER (Accélérateur pour les Sciences de la Terre, Environnement, Risques) and VERA (Vienna Environmental Research Accelerator) had been investigated by measuring samples of natural {sup 35}Cl/{sup 37}Cl-ratio and samples highly-enriched in {sup 35}Cl ({sup 35}Cl/{sup 37}Cl ∼ 999). Besides investigating and comparing the individual levels of long-term memory, recovery time constants could be calculated. The tests show that all four sources suffer from long-term memory, but the modified DREAMS ion source showed the lowest level of contamination. The recovery times of the four ion

  18. Assessing Uncertainties of Theoretical Atomic Transition Probabilities with Monte Carlo Random Trials

    Directory of Open Access Journals (Sweden)

    Alexander Kramida

    2014-04-01

    Full Text Available This paper suggests a method of evaluation of uncertainties in calculated transition probabilities by randomly varying parameters of an atomic code and comparing the results. A control code has been written to randomly vary the input parameters with a normal statistical distribution around initial values with a certain standard deviation. For this particular implementation, Cowan’s suite of atomic codes (R.D. Cowan, The Theory of Atomic Structure and Spectra, Berkeley, CA: University of California Press, 1981 was used to calculate radiative rates of magnetic-dipole and electric-quadrupole transitions within the ground configuration of titanium-like iron, Fe V. The Slater parameters used in the calculations were adjusted to fit experimental energy levels with Cowan’s least-squares fitting program, RCE. The standard deviations of the fitted parameters were used as input of the control code providing the distribution widths of random trials for these parameters. Propagation of errors through the matrix diagonalization and summation of basis state expansions leads to significant variations in the resulting transition rates. These variations vastly differ in their magnitude for different transitions, depending on their sensitivity to errors in parameters. With this method, the rate uncertainty can be individually assessed for each calculated transition.

  19. TASAR Flight Trial 2: Assessment of Air Traffic Controller Acceptability of TASAR Requests

    Science.gov (United States)

    Idris, Husni; Enea, Gabriele

    2016-01-01

    In support of the Flight Trial (FT-2) of NASA's prototype of the Traffic Aware Strategic Aircrew Requests (TASAR) concept, observations were conducted at the air traffic facilities to identify and assess the main factors that affect the acceptability of pilot requests by air traffic controllers. Two observers shadowed air traffic controllers at the Atlanta (ZTL) and Jacksonville (ZJX) air traffic control centers as the test flight pilot made pre-scripted requests to invoke acceptability issues and then they interviewed the observed and other controllers voluntarily. Fifty controllers were interviewed with experience ranging from one to thirty-five years. All interviewed controllers were enthusiastic about the technology and accounting for sector boundaries in pilot requests, particularly if pilots can be made aware of high workload situations. All interviewed controllers accept more than fifty percent of pilot requests; forty percent of them reject less than ten percent of requests. The most common reason for rejecting requests is conflicting with traffic followed by violating letters of agreement (LOAs) and negatively impacting neighboring sector workload, major arrival and departure flows and flow restrictions. Thirty-six requests were made during the test, eight of which were rejected due to: the aircraft already handed off to another sector, violating LOA, opposing traffic, intruding into an active special use airspace (SUA), intruding into another center, weather, and unfamiliarity with the requested waypoint. Nine requests were accepted with delay mostly because the controller needed to locate unfamiliar waypoints or to coordinate with other controllers.

  20. Assessing fidelity to treatment delivery in the ICONS (Identifying Continence OptioNs after Stroke) cluster randomised feasibility trial.

    Science.gov (United States)

    Chesworth, Brigit M; Leathley, Michael J; Thomas, Lois H; Sutton, Christopher J; Forshaw, Denise; Watkins, Caroline L

    2015-08-21

    The implementation of strategies to monitor and enhance treatment fidelity is of paramount importance in trials of complex interventions. A recent framework published by the National Institutes of Health Behavior Change Consortium recommends addressing five areas of treatment fidelity, one of which is delivery of treatment. This study aimed to explore fidelity to treatment delivery of the ICONS intervention (a systematic voiding programme [SVP]). This included exploring the feasibility of a method to assess fidelity to treatment delivery and collecting preliminary evidence of the level of fidelity to SVP delivery in order to inform strategies for improving fidelity in a future trial. Delivery of treatment was recorded by nurses through completion of daily clinical logs, which included: a voiding interval, proposed voiding times and actual voiding times. The a priori method for assessment of fidelity - comparing actual voiding times with proposed voiding times - was trialled on a small amount of data. Due to errors in documentation of the voiding intervals and proposed voiding times it was not possible to assess fidelity directly as planned. A new method was devised, which included identification of 'key quality indicators'. This new approach to assessing fidelity used key quality indicators based upon presence of the data needed to make the comparison between proposed and actual voiding times. The proportion of clinical logs with correct documentation of voiding intervals and proposed voiding times was less than 40 %. For clinical logs with correct documentation, an actual voiding time within 30 min of the proposed voiding time was identified on approximately 55 % of occasions. Lessons learnt from this study have implications for the future ICONS definitive trial and for other trials of complex interventions. Implementation of a complex intervention may often deviate from what is intended. While careful consideration should be given to the best method of

  1. Assessment of adherence to the statistical components of consolidated standards of reporting trials statement for quality of reports on randomized controlled trials from five pharmacology journals

    Directory of Open Access Journals (Sweden)

    Sachin Satpute

    2016-01-01

    Full Text Available Background: The Consolidated Standards of Reporting Trials (CONSORT statement is a device to standardize reporting and improve the quality of controlled trials. However, little attention is paid to the statistical components in the CONSORT checklist. The present study evaluates the randomized controlled trials [RCTs] published in five high impact pharmacology journals with respect to its statistical methods. Methods: Randomized Controlled Trials [RCTs] published in the years 2013 & 2014 in five pharmacology journals with high impact factor, The Journal of Clinical Pharmacology (JCP, British Journal of Clinical Pharmacology (BJCP, European Journal of Clinical Pharmacology (EJCP, Journal of Pharmacology & Pharmacotherapeutics (JPP and Indian Journal of Pharmacology (IJP were assessed for adherence to the statistical components of CONSORT statement. Results: Of the 174 RCTs analysed, 103 described the method of sample size calculation. Of the five journals, maximum reports in JCP (34/50 and minimum in IJP (13/31 adhered to the CONSORT checklist [item 7a-sample size calculation]. Most reports mentioned the statistical methods used for analysis of data. (171/174 as per the checklist [item 12=statistical methods used]. Analysis of variance (ANOVA was the most commonly used test (88/174. The software used for statistical analysis was mentioned in 111 RCTs and SPSS was used more frequently (58/111. The exact p value was stated in 108 reports. Certain errors in statistical analysis were also noted (40/174. Conclusion: These findings show inconsistencies and non- adherence to the statistical components of the CONSORT statement especially with respect to sample size calculation. Special attention must be paid to the statistical accuracy of the reports.

  2. Practical aspects of conducting a pragmatic randomised trial in primary care : Patient recruitment and outcome assessment

    NARCIS (Netherlands)

    Van Der Windt, Danielle A.W.M.; Koes, Bart W.; Van Aarst, M.; Heemskerk, Monique A.M.B.; Bouter, Lex M.

    2000-01-01

    Background. Conducting a pragmatic randomised trial in primary care is often accompanied by practical problems. Such problems are seldom reported and may constitute useful lessons for researchers planning future trials. Aim. To address the difficulties involved in patient recruitment and to present

  3. Results of the Interlaboratory Exercise CSN/CIEMAT-02 Among Environmental Radioactivity Laboratories (Sea Fish); Resultados del Ejercicio Interlaboratorios de Radiactividad Ambiental CSN/CIEMAT-02 (Fauna Marina)

    Energy Technology Data Exchange (ETDEWEB)

    Romero gonzalez, M. L.

    2003-07-01

    The document describes the outcome of the CSN/CIEMAT-02 interlaboratory test comparison among environmental radioactivity laboratories. The exercise was organised according to the ISO-43 and the ISO/IUPAC/AOAC Harmonized Protocol for the proficiency testing of analytical laboratories. The test sample was a reference materials provided by the IAEA-MEL (IAE Marine Environmental Laboratory, Monaco), a sea fish containing environmental levels of U-238, U-234, K-40, Pb-210, Ra-226, Sr-90, Cs-137, Co-60, Pu-(239+240), Am-241 and Tc-99. The results of the exercise were computed for 32 participating laboratories, and their analytical performance was assessed using the z-score approach. A raised percentage of satisfactory laboratory performance has been obtained for all the analysis, being the best performance in gamma measurements. The laboratories have made an effort to calculate the combined uncertainty of the radiochemical determinations. Most of the laboratories have demonstrated its competence in performing the study analysis and also the adequate measuring capability of their detection equipment even in conditions close to detection limits. The study has shown the capacity of participant laboratories to perform radioactive determinations in environmental sea fish samples with satisfactory quality levels. (Author) 6 refs.

  4. South Asian Heart Risk Assessment (SAHARA): Randomized Controlled Trial Design and Pilot Study

    Science.gov (United States)

    Samaan, Zainab; Schulze, Karleen M; Middleton, Catherine; Irvine, Jane; Joseph, Phillip; Mente, Andrew; Shah, Baiju R; Pare, Guillaume; Desai, Dipika

    2013-01-01

    Background People of South Asian origin suffer a high burden of premature myocardial infarction (MI). South Asians form a growing proportion of the Canadian population and preventive strategies to mitigate the risk of MI in this group are needed. Prior studies have shown that multimedia interventions are effective and feasible in inducing health behavior changes among the obese, smokers, and among those who are sedentary. Objective Among at-risk South Asians living in Canada, our objectives are to determine: (1) the feasibility of a culturally tailored multimedia intervention to induce positive behavioral changes associated with reduced MI risk factors, and (2) the effectiveness and acceptability of information communicated by individualized MI and genetic risk score (GRS) reports. Methods The South Asian HeArt Risk Assessment (SAHARA) pilot study enrolled 367 individuals of South Asian origin recruited from places of worship and community centers in Ontario, Canada. MI risk factors including the 9p21 genetic variant status were provided to all participants after the baseline visit. Participants were randomly allocated to receive a multimedia intervention or control. The intervention group selected health goals and received personalized health messages to promote adherence to their selected goals. After 6 months, all participants had their MI risk factors repeated. The methods and results of this study are reported based on the CONSORT-EHEALTH guidelines. Results The mean age of participants was 53.8 years (SD 11.4), 52.0% (191/367) were women, and 97.5% (358/367) were immigrants to Canada. The mean INTERHEART risk score was 13.0 (SD 5.8) and 73.3% (269/367) had one or two copies of the risk allele for the 9p21 genetic variant. Both the intervention and control groups made some progress in health behavior changes related to diet and physical activity over 6 months. Participants reported that their risk score reports motivated behavioral changes, although half of

  5. Inter-laboratory comparison of HITU power measurement methods and capabilities

    International Nuclear Information System (INIS)

    Jenderka, K V; Durando, G; Karaboece, B; Rajagopal, S; Shaw, A

    2011-01-01

    High Intensity Therapeutic Ultrasound (HITU) is gaining in importance among the spectrum of therapeutic options to combat cancer. HITU has already been approved and is in clinical use for the treatment of organs like the prostate, the liver and the uterus. Nevertheless, the metrology of the applied high power ultrasound fields, and in consequence, reliable treatment planning and monitoring, is still a challenge. As part of a European Metrology Research Programme project, the four National Metrology Institutes from the UK, Germany, Italy and Turkey conducted an inter-laboratory comparison of their power measurement capabilities at power levels of 5, 25, 75 and 150 W each at frequencies of 1.1, 1.5 and 3.3 MHz. The task was to measure the total, time-averaged ultrasonic output power, emitted by the circulated transducers under specified electrical excitation conditions into an anechoic water load, and the actual rms transducer input voltage. The output value to be reported was the electro-acoustic radiation conductance including the associated standard and expanded uncertainties. Several different measurement techniques were applied to gain further insight into HITU power measurement. The deviations from the calculated comparison reference value found for the different techniques are discussed and conclusions for the further improvement of measuring procedures are drawn.

  6. An interlaboratory comparison programme for several toxic substances in blood and urine.

    Science.gov (United States)

    Weber, J P

    1988-04-01

    Since 1979, the Centre de Toxicologie du Québec has operated an interlaboratory comparison programme for several toxic substances in blood and urine. We initiated this program due to the unavailability of reliable and representative reference materials for toxic elements in blood and urine. The main objective is to enable participants to improve or maintain the accuracy of their analytical work by periodically comparing their results. There are presently 76 laboratories registered in the programme for one or more substances. The majority are located in North America with several others in Europe and South America. Available substances include lead and cadmium in blood, aluminum in serum, and mercury, arsenic, cadmium, fluoride and chromium in urine. Samples are prepared by pooling specimens obtained from exposed workers. We have examined the performance of participants over the course of the years using as criteria the deviation from the target value, the scatter of results and the proficiency within preset limits of toxicological significance. Whenever possible the influence of analytical methods was evaluated. The feedback provided by participation in the programme appears to be a significant factor in the maintenance or improvement of analytical proficiency. The vast majority of participants obtain results of adequate reliability for use in the monitoring of exposed workers.

  7. Degradation in PV Encapsulation Transmittance: An Interlaboratory Study Toward a Climate-Specific Test

    Energy Technology Data Exchange (ETDEWEB)

    Miller, David C.; Hacke, Peter L.; Kempe, Michael D.; Wohlgemuth, John H.; Annigoni, Eleonora; Sculati-Meillaud, Fanny; Ballion, Amal; Kohl, Michael; Bokria, Jayesh G.; Bruckman, Laura S.; French, Roger H.; Burns, David; Phillips, Nancy H.; Feng; Jiangtao; Elliott, Lamont; Scott, Kurt P.; Fowler, Sean; Gu, Xiaohong; Honeker, Christian C.; Khonkar, Hussam; Perret-Aebi, Laure-Emmanuelle; Shioda, Tsy

    2015-06-14

    Reduced optical transmittance of encapsulation resulting from ultraviolet (UV) degradation has frequently been identified as a cause of decreased PV module performance through the life of installations in the field. The present module safety and qualification standards, however, apply short UV doses only capable of examining design robustness or 'infant mortality' failures. Essential information that might be used to screen encapsulation through product lifetime remains unknown. For example, the relative efficacy of xenon-arc and UVA-340 fluorescent sources or the typical range of activation energy for degradation is not quantified. We have conducted an interlaboratory experiment to provide the understanding that will be used towards developing a climate- and configuration-specific (UV) weathering test. Five representative, known formulations of EVA were studied in addition to one TPU material. Replicate laminated silica/polymer/silica specimens are being examined at 14 institutions using a variety of indoor chambers (including Xe, UVA-340, and metal-halide light sources) or field aging. The solar-weighted transmittance, yellowness index, and the UV cut-off wavelength, determined from the measured hemispherical transmittance, are examined to provide understanding and guidance for the UV light source (lamp type) and temperature used in accelerated UV aging tests. Index Terms -- reliability, durability, thermal activation.

  8. Degradation in PV Encapsulation Transmittance: An Interlaboratory Study Towards a Climate-Specific Test: Preprint

    Energy Technology Data Exchange (ETDEWEB)

    Miller, David C.; Annigoni, Eleonora; Ballion, Amal; Bokria, Jayesh G.; Bruckman, Laura S.; Burns, David M.; Chen, Xinxin; Elliott, Lamont; Feng, Jiangtao; French, Roger H.; Fowler, Sean; Gu, Xiaohong; Hacke, Peter L.; Honeker, Christian C.; Kempe, Michael D.; Khonkar, Hussam; Kohl, Michael; Perret-Aebi, Laure-Emmanuelle; Phillips, Nancy H.; Scott, Kurt P.; Sculati-Meillaud, Fanny; Shioda, Tsuyos

    2015-08-12

    Reduced optical transmittance of encapsulants resulting from ultraviolet (UV) degradation has frequently been identified as a cause of decreased PV module performance through the life of service in the field. The present module safety and qualification standards, however, apply short UV doses only capable of examining design robustness or 'infant mortality' failures. Essential information that might be used to screen encapsulation through product lifetime remains unknown. For example, the relative efficacy of xenon-arc and UVA-340 fluorescent sources or the typical range of activation energy for degradation is not quantified. We have conducted an interlaboratory experiment to provide the understanding that will be used towards developing a climate- and configuration-specific (UV) weathering test. Five representative, known formulations of EVA were studied in addition to one TPU material. Replicate laminated silica/polymer/silica specimens are being examined at 14 institutions using a variety of indoor chambers (including Xenon, UVA-340, and metal-halide light sources) or field aging. The solar-weighted transmittance, yellowness index, and the UV cut-off wavelength, determined from the measured hemispherical transmittance, are examined to provide understanding and guidance for the UV light source (lamp type) and temperature used in accelerated UV aging tests.

  9. Degradation in PV Encapsulant Strength of Attachment: An Interlaboratory Study Towards a Climate-Specific Test

    Energy Technology Data Exchange (ETDEWEB)

    Miller, David C.; Annigoni, Eleonora; Ballion, Amal; Bokria, Jayesh G.; Bruckman, Laura S.; Burns, David M.; Chen, Xinxin; Feng, Jiangtao; French, Roger H.; Fowler, Sean; Honeker, Christian C.; Kempe, Michael D.; Khonkar, Hussam; Kohl, Michael; Perret-Aebi, Laure-Emmanuelle; Phillips, Nancy H.; Scott, Kurt P.; Sculati-Meillaud, Fanny; Wohlgemuth, John H.

    2016-11-21

    Reduced strength of attachment of the encapsulant resulting from the outdoor environment, including ultraviolet (UV) radiation, may decrease photovoltaic (PV) module lifetime by enabling widespread corrosion of internal components. To date, few studies exist showing how the adhesion of PV components varies with environmental stress. We have conducted an interlaboratory experiment to provide an understanding that will be used to develop climatic specific module tests. Factors examined in the study included the UV light source (lamp type), temperature, and humidity to be proposed for use in accelerated aging tests. A poly (ethylene-co-vinyl acetate) (EVA) formulation often used in veteran PV installations was studied using a compressive shear test - to quantify the strength of attachment at the EVA/glass interface. Replicate laminated glass/polymer/glass coupon specimens were weathered at 12 institutions using a variety of indoor chambers or field aging. Shear strength, shear strain, and toughness were measured using a mechanical load-frame for the compressive shear test, with subsequent optical imaging and electron microscopy of the separated surfaces.

  10. Degradation in PV Encapsulation Strength of Attachment: An Interlaboratory Study Towards a Climate-Specific Test

    Energy Technology Data Exchange (ETDEWEB)

    Miller, David; Annigoni, Eleonora; Ballion, Amal; Bokria, Jayesh G.; Bruckman, Laura S.; Burns, David M.; Chen, Xinxin; Feng, Jiangtao; French, Roger H.; Fowler, Sean; Honeker, Christian C.; Kempe, Michael; Khonkar, Hussam; Kohl, Michael; Perret-Aebi, Laure-Emmanuelle; Phillips, Nancy H.; Scott, Kurt P.; Sculati-Meillaud, Fanny; Wohlgemuth, John

    2016-06-06

    Reduced strength of attachment of the encapsulant resulting from the outdoor environment, including ultraviolet (UV) radiation, may decrease photovoltaic (PV) module lifetime by enabling widespread corrosion of internal components. To date, few studies exist showing how the adhesion of PV components varies with environmental stress. We have conducted an interlaboratory experiment to provide an understanding that will be used to develop climatic specific module tests. Factors examined in the study included the UV light source (lamp type), temperature, and humidity to be proposed for use in accelerated aging tests. A poly (ethylene-co-vinyl acetate) (EVA) formulation often used in veteran PV installations was studied using a compressive shear test - to quantify the strength of attachment at the EVA/glass interface. Replicate laminated glass/polymer/glass coupon specimens were weathered at 12 institutions using a variety of indoor chambers or field aging. Shear strength, shear strain, and toughness were measured using a mechanical load-frame for the compressive shear test, with subsequent optical imaging and electron microscopy of the separated surfaces.

  11. Interlaboratory Study on Caprolactam Test for Food-Contact Nylon Products.

    Science.gov (United States)

    Watanabe, Kazunari; Mutsuga, Motoh; Abe, Takashi; Abe, Tomoyuki; Abe, Yutaka; Ohsaka, Ikue; Ohno, Haruka; Ohno, Hiroyuki; Ohno, Yuichiro; Ozaki, Asako; Kakihara, Yoshiteru; Kobayashi, Hisashi; Kondo, Takahide; Shibata, Hiroshi; Shirono, Katsuhiro; Sekido, Haruko; Sonobe, Hironori; Takasaka, Noriko; Tajima, Yoshiyasu; Tanaka, Aoi; Tanaka, Hideyuki; Nakanishi, Toru; Nomura, Chie; Haneishi, Nahoko; Hayakawa, Masato; Hikida, Akinori; Miura, Toshihiko; Yamaguchi, Miku; Sato, Kyoko; Akiyama, Hiroshi

    2016-01-01

    The Japanese Food Sanitation Law sets a limit on the migration level of caprolactam for food-contacting nylon products. Here, we carried out an interlaboratory study in twenty laboratories to evaluate the performance of the official GC-FID test method and a GC-MS method as an alternative test method to the official method. Each laboratory quantified caprolactam in three test solutions in 20% ethanol as blind duplicates using GC-FID or GC-MS. The official method (GC-FID with absolute calibration) gave trueness, repeatability (RSDr) and reproducibility (RSDr) values of 96-97%, 3.3-5.4% and 4.0-6.7%, respectively. These values met the target criteria (trueness: 80-110%, RSDr: 10%, RSDr: 25%). The performance of the method was further improved by the introduction of heptalactam as an internal standard. As for GC-MS method, some values of the RSDr exceeded 10% when absolute calibration was used. However, when an internal standard was introduced, the trueness, RSDr and RSDr of GC-MS method were all acceptable at 94-96%, 2.0-4.4% and 7.0-9.4%, respectively. Therefore, GC-MS with an internal standard is available as an alternative test method to the official method.

  12. Tendency for interlaboratory precision in the GMO analysis method based on real-time PCR.

    Science.gov (United States)

    Kodama, Takashi; Kurosawa, Yasunori; Kitta, Kazumi; Naito, Shigehiro

    2010-01-01

    The Horwitz curve estimates interlaboratory precision as a function only of concentration, and is frequently used as a method performance criterion in food analysis with chemical methods. The quantitative biochemical methods based on real-time PCR require an analogous criterion to progressively promote method validation. We analyzed the tendency of precision using a simplex real-time PCR technique in 53 collaborative studies of seven genetically modified (GM) crops. Reproducibility standard deviation (SR) and repeatability standard deviation (Sr) of the genetically modified organism (GMO) amount (%) was more or less independent of GM crops (i.e., maize, soybean, cotton, oilseed rape, potato, sugar beet, and rice) and evaluation procedure steps. Some studies evaluated whole steps consisting of DNA extraction and PCR quantitation, whereas others focused only on the PCR quantitation step by using DNA extraction solutions. Therefore, SR and Sr for GMO amount (%) are functions only of concentration similar to the Horwitz curve. We proposed S(R) = 0.1971C 0.8685 and S(r) = 0.1478C 0.8424, where C is the GMO amount (%). We also proposed a method performance index in GMO quantitative methods that is analogous to the Horwitz Ratio.

  13. Evaluation of an interlaboratory comparison of the chemical assay of U, Th, oxide coated particles

    International Nuclear Information System (INIS)

    Tamberg, T.; Thiele, D.; Brodda, B.G.

    1981-09-01

    The prototype reactor THTR in Schmehausen (Germany, F.R.) burns a (Th,U)O 2 nuclear fuel using 93% enriched uranium. This material is particularly Safeguards sensitive. It was therefore desirable for the Safeguards Analytical Laboratory (SAL) and other laboratories of the Agency Network to collect experience and test their performance in the analysis of such materials. Support was requested from the ''Joint Programme between the IAEA and the Federal Republic of Germany for the Development of Safeguards Techniques'' to perform, as a first step, an interlaboratory comparison of the chemical assay of U and Th in pyrocarbon-coated BISO-type fuel particles. Such an intercomparison was organized under the auspices of the Institut fuer Chemische Technologie (ICT) of the Kernforschungsanlage Juelich GmbH (KFA). SAL prepared a statistical evaluation of the results which was discussed in Vienna in June 1980. The objective of the project was to define the state of the art in the chemical assay of U-Th fuels and the analytical requirements for the sampling of materials of major interest to Agency Safeguards at present

  14. Inter-laboratory comparison of HITU power measurement methods and capabilities

    Energy Technology Data Exchange (ETDEWEB)

    Jenderka, K V [Physikalisch-Technische Bundesanstalt (PTB), Bundesallee 100, 38116 Braunschweig (Germany); Durando, G [Istituto Nazionale di Ricerca Metrologica (INRIM), Strada delle Cacce 91, 10135 Torino (Italy); Karaboece, B [Tuebitak Ulusal Metroloji Enstituesue (UME), P.K. 54 41470 Gebze-Kocaeli (Turkey); Rajagopal, S; Shaw, A, E-mail: kvjend@ieee.org [National Physical Laboratory (NPL), Hampton Road, Teddington, TW11 0LW (United Kingdom)

    2011-02-01

    High Intensity Therapeutic Ultrasound (HITU) is gaining in importance among the spectrum of therapeutic options to combat cancer. HITU has already been approved and is in clinical use for the treatment of organs like the prostate, the liver and the uterus. Nevertheless, the metrology of the applied high power ultrasound fields, and in consequence, reliable treatment planning and monitoring, is still a challenge. As part of a European Metrology Research Programme project, the four National Metrology Institutes from the UK, Germany, Italy and Turkey conducted an inter-laboratory comparison of their power measurement capabilities at power levels of 5, 25, 75 and 150 W each at frequencies of 1.1, 1.5 and 3.3 MHz. The task was to measure the total, time-averaged ultrasonic output power, emitted by the circulated transducers under specified electrical excitation conditions into an anechoic water load, and the actual rms transducer input voltage. The output value to be reported was the electro-acoustic radiation conductance including the associated standard and expanded uncertainties. Several different measurement techniques were applied to gain further insight into HITU power measurement. The deviations from the calculated comparison reference value found for the different techniques are discussed and conclusions for the further improvement of measuring procedures are drawn.

  15. Experience of an inter-laboratory exercise for the determination of Carbon-14 in biological samples

    International Nuclear Information System (INIS)

    Baburajan, A.; Rajaram, S.; D'Souza, Renita Shiny; Nayak, Rasmi; Karunakara, N.; Ravi, P.M.; Tripathi, R.M.

    2018-01-01

    Carbon-14 is one of the naturally occurring cosmogenic nuclide with long half life of 5730 y and beta energy, E max : 156 keV produced continuously in the outer atmosphere. It is also produced by the anthropogenic activities like nuclear weapon test, nuclear power plant etc. contributing to the atmospheric inventory. The 14 CO 2 gets incorporated with the plant species during photosynthesis and ultimately reaches to man through food chain. It is important to accurately quantify the level of 14 C in different biological matrices for the computation of radiation dose due to ingestion. There are different methods available for the determination of 14 C in biological samples. The oxidation of the dried sample is one of the methods used for liberating the 14 CO 2 and which in turn re-absorbed using Carbo Sorb and subjected to Liquid scintillation analyses with Permaflour scintillator solution. The paper deals with the quality assurance programme initiated by ESL, Tarapur along with ESL, Kalpakkam and CARER, Mangalore University and share the experience of the inter-laboratory comparison exercise

  16. Interlaboratory study of immunochromatography for the rapid determination of cadmium concentrations in cereals and soybeans.

    Science.gov (United States)

    Abe, Kaoru; Nakamura, Katsuo; Naito, Shigehiro

    2014-01-01

    Cadmium (Cd) is one of the most toxic heavy metals to humans. To prevent the distribution of Cd-contaminated food, a simple and quick on-site test for measuring Cd concentrations in agricultural products is needed. Recently, an immunochromatography kit developed for determining Cd in rice was reported to be useful for determining Cd in many other crops. We conducted an interlaboratory study to evaluate the kit for determining Cd in cereals (wheat and rice) and soybeans. Ten test materials were used, and 12 test samples including two sets of blind duplicates were distributed to 12 laboratories in Japan. The Cd recoveries (relative to certified values or values determined by inductively coupled plasma-MS) from all test materials were 84.6-125.1%. Repeatability RSD values of the test materials ranged from 8.8 to 14.8%. Reproducibility RSD values ranged from 13.4 to 27.6%, averaging 21.3%. The Horwitz ratio ranged from 0.61 to 1.36. The reproducibility was within the range of ELISA results for measuring toxins and allergens in food. Our results indicated that the kit was an inexpensive, reliable tool for quick and easy on-site determination of Cd in cereals and soybeans.

  17. First European interlaboratory study of the analysis of benzoxazinone derivatives in plants by liquid chromatography.

    Science.gov (United States)

    Eljarrat, E; Guillamón, M; Seuma, J; Mogensen, B B; Fomsgaard, I S; Olivero-Bastidas, A; Macías, F A; Stochmal, A; Oleszek, W; Shakaliene, O; Barceló, D

    2004-08-20

    Six laboratories from four different countries participated in the first European interlaboratory comparison exercise within the framework of the "Fate and toxicity of allelochemicals (natural plant toxins) in relation to environment and consumer" (FATEALLCHEM) European Union Project. The study, organized between November 2002 and March 2003, involved the analyses of seven benzoxazinone derivatives in two standard solutions and one purified extract of root material. Results are reported from the first phase of the study that examined the variability associated with different detection methods and different laboratories. The analytical strategies were based on liquid chromatography (LC) with diode array detection, LC coupled to mass spectrometry (MS) and LC coupled to tandem MS. When data from all laboratories were pooled, the relative standard deviation values ranged from 2 to 14% for the determination of target compounds in standard solutions, and between 19 and 47% for the analysis in root material. Comparison of the three detection techniques leads to the conclusion that MS approaches are the most accurate and precise techniques for the determination of benzoxazinone derivatives at ng/microL level in plant material.

  18. Verification of Electromagnetic Field Measurements via Inter-laboratory Comparison Measurements

    Directory of Open Access Journals (Sweden)

    M. Mann

    2005-01-01

    Full Text Available An inter-laboratory comparison of field strength measurements was conducted in order to verify the comparability of high-frequency electromagnetic field measurements. For this purpose, 17 participating teams hosted by the working group "procedures of exposure determination" of the LAI (Länderausschuss für Immissionsschutz, state committee on immission control determined the field strength at given stations around a hospital situation. At those stations very different signals were generated, such as sine wave signals at 27MHz and 433MHz, signals from a diathermy device in Continuous-Wave (CW and Pulse-Width-Modulation (PWM mode, from a GSM base station at 900MHz and 1800MHz, from a UMTS base station, from a babyphone device and from a DECT cordless phone. This contribution describes the evaluation of the measured values and the approach to the computation of a reference value. Considering various sources of electromagnetic fields in the areas of personal safety at work and of immission control, the most important results are presented and the conclusions drawn are discussed.

  19. Design of a Phase III cluster randomized trial to assess the efficacy and safety of a malaria transmission blocking vaccine.

    Science.gov (United States)

    Delrieu, Isabelle; Leboulleux, Didier; Ivinson, Karen; Gessner, Bradford D

    2015-03-24

    Vaccines interrupting Plasmodium falciparum malaria transmission targeting sexual, sporogonic, or mosquito-stage antigens (SSM-VIMT) are currently under development to reduce malaria transmission. An international group of malaria experts was established to evaluate the feasibility and optimal design of a Phase III cluster randomized trial (CRT) that could support regulatory review and approval of an SSM-VIMT. The consensus design is a CRT with a sentinel population randomly selected from defined inner and buffer zones in each cluster, a cluster size sufficient to assess true vaccine efficacy in the inner zone, and inclusion of ongoing assessment of vaccine impact stratified by distance of residence from the cluster edge. Trials should be conducted first in areas of moderate transmission, where SSM-VIMT impact should be greatest. Sample size estimates suggest that such a trial is feasible, and within the range of previously supported trials of malaria interventions, although substantial issues to implementation exist. Copyright © 2015 Elsevier Ltd. All rights reserved.

  20. Assessment of Sexual Desire for Clinical Trials of Women With Hypoactive Sexual Desire Disorder: Measures, Desire-Related Behavior, and Assessment of Clinical Significance.

    Science.gov (United States)

    Pyke, Robert E; Clayton, Anita H

    2018-01-19

    The Female Sexual Function Index-desire subscale is the standard measure for clinical trials of hypoactive sexual desire disorder (HSDD), but lacks items assessing sexually related behaviors and attitudes toward partner. Counting satisfying sexual events is criticized, but sexual behavior remains important. Mean treatment differences cannot define clinical significance; responder and remitter analyses help. We reviewed measures on sexual desire and sexual behavior relevant to HSDD, and how to assess clinical significance. We conducted a literature review of measures of sexual desire comparing expert-proposed criteria for dysfunctional desire, expert-developed scales, and scales from patient input. Commonly recognized symptoms of HSDD were identified. Results of HSDD trials and scale validation studies were evaluated to extract responder and remitter values. The utility of distribution-based measures of responders and remitters was assessed. Symptom relevance was evaluated as the proportion of symptom sets that included the item; responder and remitter cut points were determined by distribution-based methods. 12 Validated rating scales, 5 scales primarily derived from expert recommendations and 7 scales initially from patient input, and 5 sets of diagnostic criteria for conditions like HSDD were compared. Content varied highly between scales despite compliance with U.S. Food and Drug Administration recommendations for patient-reported outcomes. This disunity favors an expert-recommended scale such as the Elements of Desire Questionnaire with each of the common items, plus a measure of frequency of sexual activity, eg, item in the Patient Reported Outcomes Measurement Information System. Registrational drug trials, but not psychological treatment trials, usually give responder/remitter analyses, using dichotomized global impressions or anchor-based definitions. Distribution-based methods are more uniformly applicable to define responder and remitter status. The

  1. Student assessment of teaching effectiveness of "bundle of changes"-A paired, controlled trial

    Directory of Open Access Journals (Sweden)

    Seema Kalra

    2011-01-01

    Full Text Available Background : Inching toward optimum patient safety by training personnel is the prime aim of the ongoing medical education. Aims : To assess whether lectures targeted to improve quality care in ICU could improve ICU practitioners′ knowledge levels and to evaluate the effectiveness of teaching. Settings and Design : In this paired controlled trial, 50 ICU practitioners, i.e., anesthesia and medicine residents and nursing staff of our hospital attended a series of four lectures. Materials and Methods : Participants enrolled in the study attended lectures on "bundles of changes" in ICU, namely, introduction, ventilator bundle, central line bundle, and catheter-related blood stream infections and severe sepsis bundle. They were given a questionnaire of 15 multiple choice questions prior to and after the lectures. We evaluated their immediate knowledge acquisition and retention recall. Subsequently, they evaluated the effectiveness of the teaching programme by a questionnaire of 10 multiple choice questions. Statistical analysis used: Data for statistical analysis were tabulated and analyzed using SPSS-Pc 11.5 version software. Results : Fifty study participants completed all three questionnaires. There was an increase in the overall mean score in the post-lecture test (4.58 + 1.51 SD (P < 0.001. Overall mean score increased significantly from 8.30 + 1.34 SD in THE pre-lecture test - to 12.02 + 1.61 SD in the postlecture re-test (3.72 + 1.39 SD (P < 0.001. In the evaluation of teaching effectiveness 88% respondents agreed to most of the questions, signifying the effectiveness of the lectures. However, there were 10% who disagreed to the questions and only 2% strongly disagreed to all the questions. Conclusions : Teaching programmes such as the "bundle of changes" are effective in improving immediate knowledge acquisition and retention recall of the participants if designed keeping the target audience in mind.

  2. Randomized Clinical Trial to Assess the Efficacy of Radiotherapy in Primary Mediastinal Large B-Lymphoma

    International Nuclear Information System (INIS)

    Avilés, Agustin; Neri, Natividad; Fernández, Raúl; Huerta-Guzmán, Judith; Nambo, María J.

    2012-01-01

    Purpose: We developed a controlled clinical trial to assess the efficacy and toxicity of adjuvant-involved field radiotherapy (IFRT) in patients with primary mediastinal B-cell lymphoma that achieved complete response after the patients were treated with cyclophosphamide, doxorubicin, vincristine, prednisone, and rituximab (R-CHOP-14). Methods and Materials: Between January 2001 and June 2004, 124 consecutive patients who were in complete remission after dose dense chemotherapy and rituximab administration (R-CHOP14) were randomly assigned to received IFRT (30 Gy). Sixty-three patients received IFR, and 61 patients did not (control group). Results: The study aimed to include 182 patients in each arm but was closed prematurely because in a security analysis (June 2004), progression and early relapse were more frequent in patients that did not received IFRT. Patients were followed until March 2009, at which point actuarial curves at 10 years showed that progression free-survival was 72% in patients who received IFR and 20% in the control group (p < 0.001), overall survival was 72% and 31%, respectively (p < 0.001). Acute toxicity was mild and well tolerated. Discussion: Adjuvant radiotherapy to sites of bulky disease was the only difference to have an improvement in outcome in our patients; the use of rituximab during induction did not improve complete response rates and did affect overall survival; patients who received rituximab but not IFRT had a worse prognosis. Conclusions: The use of IFRT in patients with primary mediastinal B-cell lymphoma who achieved complete response remain as the best treatment available, even in patients that received rituximab during induction.

  3. Assessment of chemomechanical removal of carious lesions using Papacarie Duo ™: Randomized longitudinal clinical trial

    Directory of Open Access Journals (Sweden)

    Simone Ferreira Borges Matsumoto

    2013-01-01

    Full Text Available Background: Chemomechanical removal of carious lesions consists of the dissolution of carious tissue by the application of a natural or synthetic agent, followed by atraumatic mechanical removal. Aim: The aim of the present study was to assess the effectiveness of Papacarie Duo ® gel in the chemomechanical removal of carious lesions in primary teeth in comparison to the traditional method (low-speed bur. Settings and Design: A randomized clinical trial was conducted with 20 children between 5 and 8 years of age. Materials and Methods: Two teeth were treated in each child (split-mouth design, with the randomization of two methods: Group 1 - chemomechanical caries removal with Papacarie Duo™; and Group 2 - removal of carious dentin tissue using a low-speed bur. Both methods involved restoration with glass ionomer cement and follow up. The following aspects were evaluated: time required for the procedure; pain (face evaluation scale; rtention of the restorative material in the cavity; and the presence of secondary caries after 30 days. Statistical Analysis Used: Chi-squared test, Student′s t-test, and Wilcoxon test. Results: No statistically significant differences between methods were found regarding time required for the procedure (P = 0.13, the occurrence of pain (P = 0.585, or restoration status at the 30-day clinical evaluation (P = 0.713. Conclusion: The findings of the present study demonstrate that the two methods achieve similar results. The advantages of minimally invasive treatment, such as chemomechanical caries removal with Papacarie Duo™, are its ease of use, patient comfort, and the fact that it causes less damage to dental tissue.

  4. Assessing the Effectiveness of Case-Based Collaborative Learning via Randomized Controlled Trial.

    Science.gov (United States)

    Krupat, Edward; Richards, Jeremy B; Sullivan, Amy M; Fleenor, Thomas J; Schwartzstein, Richard M

    2016-05-01

    Case-based collaborative learning (CBCL) is a novel small-group approach that borrows from team-based learning principles and incorporates elements of problem-based learning (PBL) and case-based learning. CBCL includes a preclass readiness assurance process and case-based in-class activities in which students respond to focused, open-ended questions individually, discuss their answers in groups of 4, and then reach consensus in larger groups of 16. This study introduces CBCL and assesses its effectiveness in one course at Harvard Medical School. In a 2013 randomized controlled trial, 64 medical and dental student volunteers were assigned randomly to one of four 8-person PBL tutorial groups (control; n = 32) or one of two 16-person CBCL tutorial groups (experimental condition; n = 32) as part of a required first-year physiology course. Outcomes for the PBL and CBCL groups were compared using final exam scores, student responses to a postcourse survey, and behavioral coding of portions of video-recorded class sessions. Overall, the course final exam scores for CBCL and PBL students were not significantly different. However, CBCL students whose mean exam performance in prior courses was below the participant median scored significantly higher than their PBL counterparts on the physiology course final exam. The most common adjectives students used to describe CBCL were "engaging," "fun," and "thought-provoking." Coding of observed behaviors indicated that individual affect was significantly higher in the CBCL groups than in the PBL groups. CBCL is a viable, engaging, active learning method. It may particularly benefit students with lower academic performance.

  5. Methodological challenges in assessing the impact of comorbidities on costs in Alzheimer's disease clinical trials.

    Science.gov (United States)

    Kahle-Wrobleski, Kristin; Fillit, Howard; Kurlander, Jonathan; Reed, Catherine; Belger, Mark

    2015-12-01

    Alzheimer's disease (AD) is associated with considerable costs and has a significant impact on health and social care systems. This study assessed whether baseline comorbidities present in 2,594 patients with AD participating in two semagacestat randomized placebo-controlled trials (RCTs) would significantly impact overall costs. Resource utilization was captured using the Resource Utilization in Dementia Scale-Lite. Comorbidities and concomitant medications were tabulated via patient and caregiver reports. Only baseline data were analyzed. Direct and indirect costs per month were calculated per patient. The relationship between cost and explanatory variables was explored in a regression model. The baseline monthly cost of care in this RCT population was £1,147 ± 2,483, with informal care costs accounting for 75% of costs. Gender, age, and functional status were significant predictors of costs (p ≤ 0.0001). The cost ratio was not impacted when the number of comorbidities was added to the model (cost ratio = 0.95; 95% CI 0.91-0.99) or when combined with the number of concomitant medications (cost ratio = 0.97; 95% CI 0.95-1.00). Inconsistent findings related to the impact of individual comorbidities on costs were noted in sensitivity analyses. The number of comorbidities, alone or when combined with concomitant medications, did not impact baseline costs of care, perhaps because RCTs often enroll less severely ill and more medically stable patients. However, higher costs were consistently associated with greater functional impairment similar to non-RCT databases. Supplemental sources (e.g., claims databases) are likely needed to better estimate the effects of disease and treatment on costs of illness captured in RCTs for AD.

  6. Randomized Clinical Trial to Assess the Efficacy of Radiotherapy in Primary Mediastinal Large B-Lymphoma

    Energy Technology Data Exchange (ETDEWEB)

    Aviles, Agustin, E-mail: agustin.aviles@imss.gob.mx [Oncology Research Unit, Oncology Hospital, National Medical Center, IMSS, Mexico, D. F. (Mexico); Neri, Natividad [Department of Hematology, Oncology Hospital, National Medical Center, IMSS, Mexico, D. F. (Mexico); Fernandez, Raul [Department of Radiation Therapy, Oncology Hospital, National Medical Center, IMSS, Mexico, D. F. (Mexico); Huerta-Guzman, Judith; Nambo, Maria J. [Department of Hematology, Oncology Hospital, National Medical Center, IMSS, Mexico, D. F. (Mexico)

    2012-07-15

    Purpose: We developed a controlled clinical trial to assess the efficacy and toxicity of adjuvant-involved field radiotherapy (IFRT) in patients with primary mediastinal B-cell lymphoma that achieved complete response after the patients were treated with cyclophosphamide, doxorubicin, vincristine, prednisone, and rituximab (R-CHOP-14). Methods and Materials: Between January 2001 and June 2004, 124 consecutive patients who were in complete remission after dose dense chemotherapy and rituximab administration (R-CHOP14) were randomly assigned to received IFRT (30 Gy). Sixty-three patients received IFR, and 61 patients did not (control group). Results: The study aimed to include 182 patients in each arm but was closed prematurely because in a security analysis (June 2004), progression and early relapse were more frequent in patients that did not received IFRT. Patients were followed until March 2009, at which point actuarial curves at 10 years showed that progression free-survival was 72% in patients who received IFR and 20% in the control group (p < 0.001), overall survival was 72% and 31%, respectively (p < 0.001). Acute toxicity was mild and well tolerated. Discussion: Adjuvant radiotherapy to sites of bulky disease was the only difference to have an improvement in outcome in our patients; the use of rituximab during induction did not improve complete response rates and did affect overall survival; patients who received rituximab but not IFRT had a worse prognosis. Conclusions: The use of IFRT in patients with primary mediastinal B-cell lymphoma who achieved complete response remain as the best treatment available, even in patients that received rituximab during induction.

  7. An assessment of early Child Life Therapy pain and anxiety management: A prospective randomised controlled trial.

    Science.gov (United States)

    Hyland, Ela J; D'Cruz, Rachel; Harvey, John G; Moir, Jordyn; Parkinson, Christina; Holland, Andrew J A

    2015-12-01

    Burns remain extremely painful and distressing in young children. The consequences of poorly managed pain and anxiety can be life-long. Whilst Child Life Therapy (CLT) has been shown to be effective in many situations, few studies have looked at the effectiveness of CLT in regard to reducing pain and anxiety in children undergoing burn dressing changes. A prospective, randomised controlled trial was conducted, comparing CLT versus standard care in relation to pain and anxiety scores of children undergoing their initial burn dressing change. Pain and anxiety were assessed by an independent observer and questionnaires completed by the child, parent/caregiver and nursing staff. 50 subjects were recruited in each treatment group; median age 2.3 years (CLT) and 2.2 years (standard care). The median total body surface area (TBSA) burnt was 0.8% (CLT) and 0.5% (standard care). The majority were partial thickness dermal burns (88% CLT, 94% standard care). Rates of parent anxiety and pre-procedural child pain and anxiety were similar. Combined and scaled pain and anxiety scores in the CLT group were significantly less than in the standard treatment group (p=0.03). Whilst pain was significantly better in the CLT group (p=0.02), fear scores, wound outcomes and the need for skin grafting were not statistically different in either group. The presence of a Child Life Therapist, with their ability to adapt to the environment, the child and their family, significantly reduced the experience of pain during paediatric burn dressings. Copyright © 2015 Elsevier Ltd and ISBI. All rights reserved.

  8. Comprehensive Geriatric Assessment for Prevention of Delirium After Hip Fracture: A Systematic Review of Randomized Controlled Trials.

    Science.gov (United States)

    Shields, Lynn; Henderson, Victoria; Caslake, Robert

    2017-07-01

    To assess the efficacy of comprehensive geriatric assessment (CGA) in prevention of delirium after hip fracture. Systematic review and metaanalysis. Ward based models on geriatrics wards and visiting team based models on orthopaedics wards were included. Four trials (three European, one U.S.; 973 participants) were identified. Two assessed ward-based, and two assessed team-based interventions. MEDLINE, EMBASE, CINAHL and PsycINFO databases; Clinicaltrials.gov; and the Central Register of Controlled Trials were searched. Reference lists from full-text articles were reviewed. Incidence of delirium was the primary outcome. Length of stay, delirium severity, institutionalization, long-term cognition and mortality were predefined secondary outcomes. Duration of delirium was included as a post hoc outcome. There was a significant reduction in delirium overall (relative risk (RR) = 0.81, 95% confidence interval (CI) = 0.69-0.94) in the intervention group. Post hoc subgroup analysis found this effect to be preserved in the team-based intervention group (RR = 0.77, 95% CI = 0.61-0.98) but not the ward-based group. No significant effect was observed on any secondary outcome. There was a reduction in the incidence of delirium after hip fracture with CGA. This is in keeping with results of non-randomized controlled trials and trials in other populations. Team-based interventions appeared superior in contrast to the Ellis CGA paper, but it is likely that heterogeneity in interventions and population studied affected this. © 2017, Copyright the Authors Journal compilation © 2017, The American Geriatrics Society.

  9. Assessing the Effectiveness of Defensive Aid Suite Technology Using a Field Trial and Modelling and Simulation

    National Research Council Canada - National Science Library

    Fournier, Pierre

    2002-01-01

    ...) community that Defensive Aid Suite (DAS) technologies can improve the protection of LAVs. A prototype DAS system was developed by DRDC Valcartier and tested in field trials held in 1995 and 1999...

  10. Assessment of clinical trial participant patient satisfaction: a call to action.

    Science.gov (United States)

    Pflugeisen, Bethann Mangel; Rebar, Stacie; Reedy, Anne; Pierce, Roslyn; Amoroso, Paul J

    2016-10-06

    As patient satisfaction scores become increasingly relevant in today's health care market, we sought to evaluate satisfaction of the unique subset of patients enrolling in clinical trials in a research facility embedded within a community hospital system. We developed and deployed a patient satisfaction survey tailored to clinical trial patients who consented to and/or completed a clinical trial in our research institute in the prior year. The survey was distributed to 222 patients. Likert scale responses were analyzed using top box and percentile rank procedures. Correlation analysis was used to evaluate associations between the clinical trial experience and intent to return to our system for routine care. Ninety surveys were returned in the 6 months following the mailing for a 41 % response rate; the bulk of these (N = 81) were returned within 6 weeks of the mailing. The questions with the highest ranking responses were related to interactions with staff (84th percentile or higher). Fifty-one point one percent of patients (64th percentile) strongly agreed that they would seek future care in our system. Patient intent to return to the provider seen during the clinical trial was most highly correlated with intent to seek future care within our system (r = 0.54, p system-based clinical trials and the relationship between clinical trial participation and perception of the healthcare system as a desirable resource for routine medical care. We argue that this work is invaluable to the research community and submit a call to action to our peers to begin systematic evaluation of clinical trial patient satisfaction.

  11. Randomised placebo controlled multicentre trial to assess short term clarithromycin for patients with stable coronary heart disease: CLARICOR trial

    DEFF Research Database (Denmark)

    Jespersen, CM; Als-Nielsen, B; Damgaard, M

    2006-01-01

    ' treatment with clarithromycin 500 mg/day or matching placebo. MAIN OUTCOME MEASURES: Primary outcome: composite of all cause mortality, myocardial infarction, or unstable angina pectoris during three years' follow-up. Secondary outcome: composite of cardiovascular mortality, myocardial infarction......, or unstable angina pectoris. The outcomes were obtained from Danish registers and were blindly assessed by the event committee. RESULTS: 2172 participants were randomised to clarithromycin and 2201 to placebo. We found no significant effects of clarithromycin on the primary outcome (hazard ratio 1.15, 95...... Copenhagen University cardiology departments and a coordinating centre. PARTICIPANTS: 13,702 patients aged 18 to 85 years who had a discharge diagnosis of myocardial infarction or angina pectoris in 1993-9 and alive in August 1999 were invited by letter; 4373 were randomised. INTERVENTIONS: Two weeks...

  12. Toward Semi-automated Assessment of Target Volume Delineation in Radiotherapy Trials: The SCOPE 1 Pretrial Test Case

    International Nuclear Information System (INIS)

    Gwynne, Sarah; Spezi, Emiliano; Wills, Lucy; Nixon, Lisette; Hurt, Chris; Joseph, George; Evans, Mererid; Griffiths, Gareth; Crosby, Tom; Staffurth, John

    2012-01-01

    Purpose: To evaluate different conformity indices (CIs) for use in the analysis of outlining consistency within the pretrial quality assurance (Radiotherapy Trials Quality Assurance [RTTQA]) program of a multicenter chemoradiation trial of esophageal cancer and to make recommendations for their use in future trials. Methods and Materials: The National Cancer Research Institute SCOPE 1 trial is an ongoing Cancer Research UK-funded phase II/III randomized controlled trial of chemoradiation with capecitabine and cisplatin with or without cetuximab for esophageal cancer. The pretrial RTTQA program included a detailed radiotherapy protocol, an educational package, and a single mid-esophageal tumor test case that were sent to each investigator to outline. Investigator gross tumor volumes (GTVs) were received from 50 investigators in 34 UK centers, and CERR (Computational Environment for Radiotherapy Research) was used to perform an assessment of each investigator GTV against a predefined gold-standard GTV using different CIs. A new metric, the local conformity index (l-CI), that can localize areas of maximal discordance was developed. Results: The median Jaccard conformity index (JCI) was 0.69 (interquartile range, 0.62-0.70), with 14 of 50 investigators (28%) achieving a JCI of 0.7 or greater. The median geographical miss index was 0.09 (interquartile range, 0.06-0.16), and the mean discordance index was 0.27 (95% confidence interval, 0.25-0.30). The l-CI was highest in the middle section of the volume, where the tumor was bulky and more easily definable, and identified 4 slices where fewer than 20% of investigators achieved an l-CI of 0.7 or greater. Conclusions: The available CIs analyze different aspects of a gold standard–observer variation, with JCI being the most useful as a single metric. Additional information is provided by the l-CI and can focus the efforts of the RTTQA team in these areas, possibly leading to semi-automated outlining assessment.

  13. Assessment of cleaning to control lead dust in homes of children with moderate lead poisoning: treatment of lead-exposed children trial.

    OpenAIRE

    Ettinger, Adrienne S; Bornschein, Robert L; Farfel, Mark; Campbell, Carla; Ragan, N Beth; Rhoads, George G; Brophy, Merrill; Wilkens, Sherry; Dockery, Douglas W

    2002-01-01

    In this article we describe the assessment and control of lead dust exposure in the Treatment of Lead-exposed Children (TLC) Trial, a clinical trial of the effects of oral chelation on developmental end points in urban children with moderately elevated blood lead levels. To reduce potential lead exposure from settled dust or deteriorated paint during the drug treatment phase of the trial, the homes of 765 (98%) of the randomized children (both active and placebo drug treatment groups) were pr...

  14. Quality of reporting of trial abstracts needs to be improved: using the CONSORT for abstracts to assess the four leading Chinese medical journals of traditional Chinese medicine

    OpenAIRE

    Yuan Wenming; Xu Lin; Zhang Mingming; Li Jing; Li Yulin; Wang Ling; Wang Gang; Hopewell Sally

    2010-01-01

    Abstract Background Due to language limitations, the abstract of journal article may be the only way for people of non-Chinese speaking countries to know about trials in traditional Chinese medicine (TCM). However, little is known about the reporting quality of these trial abstracts. Our study is to assess the reporting quality of abstracts of randomized controlled trials (RCT) published in four leading Chinese medical journals of TCM, and to identify any differences in reporting between the ...

  15. A randomised controlled trial to assess the efficacy of Laparoscopic Uterosacral Nerve Ablation (LUNA in the treatment of chronic pelvic pain: The trial protocol [ISRCTN41196151

    Directory of Open Access Journals (Sweden)

    2003-12-01

    Full Text Available Abstract Background Chronic pelvic pain is a common condition with a major impact on health-related quality of life, work productivity and health care utilisation. The cause of the pain is not always obvious as no pathology is seen in 40–60% of the cases. In the absence of pathology there is no established treatment. The Lee-Frankenhauser sensory nerve plexuses and parasympathetic ganglia in the uterosacral ligaments carry pain from the uterus, cervix and other pelvic structures. Interruption of these nerve trunks by laparoscopic uterosacral nerve ablation (LUNA may alleviate pain. However, the balance of benefits and risks of this intervention have not been reliably assessed. LUNA has, nevertheless, been introduced into practice, although there remains controversy regarding indications for LUNA. Hence, there is an urgent need for a randomised controlled trial to confirm, or refute, any worthwhile effectiveness. The principal hypothesis is that, in women with chronic pelvic pain in whom diagnostic laparoscopy reveals either no pathology or mild endometriosis (AFS score ≤ 5 LUNA alleviates pain and improves life quality at 12 months. Methods/Design The principal objective is to test the hypothesis that in women with chronic pelvic pain in whom diagnostic laparoscopy reveals either no pathology or mild endometriosis (AFS score ≤ 5 LUNA alleviates pain and improves life quality at 12 months. A multi-centre, prospective, randomised-controlled-trial will be carried out with blind assessment of outcomes in eligible consenting patients randomised at diagnostic laparoscopy to LUNA (experimental group or to no pelvic denervation (control group. Postal questionnaires including visual analogue scale for pain (primary outcome, an index of sexual satisfaction and the EuroQoL 5D-EQ instrument (secondary outcomes will be administered at 3, 6 and 12 months. The primary assessment of the effectiveness of LUNA will be from comparison of outcomes at the one

  16. A Systematic Review of Ebola Treatment Trials to Assess the Extent to Which They Adhere to Ethical Guidelines.

    Science.gov (United States)

    Richardson, Thomas; Johnston, Andrew McDonald; Draper, Heather

    2017-01-01

    base for its effectiveness against Ebola is speculative. Some limited and appropriate deviation from standard research expectations in disaster situations is increasingly accepted. However, this is not an excuse for poor ethics oversight and international regulations are in place which should not be ignored. New guidelines are needed that better define the boundaries between using medicines for compassionate use and conducting a clinical trial. Greater support should be offered for local research ethics committees in affected areas so that they can provide robust ethical review. Further systematic reviews should be carried out in epidemics of any novel infectious diseases to assess if comparable findings arise.

  17. A Systematic Review of Ebola Treatment Trials to Assess the Extent to Which They Adhere to Ethical Guidelines.

    Directory of Open Access Journals (Sweden)

    Thomas Richardson

    pre-trial evidence base for its effectiveness against Ebola is speculative.Some limited and appropriate deviation from standard research expectations in disaster situations is increasingly accepted. However, this is not an excuse for poor ethics oversight and international regulations are in place which should not be ignored. New guidelines are needed that better define the boundaries between using medicines for compassionate use and conducting a clinical trial. Greater support should be offered for local research ethics committees in affected areas so that they can provide robust ethical review. Further systematic reviews should be carried out in epidemics of any novel infectious diseases to assess if comparable findings arise.

  18. Assessment of Suicidal Ideation and Behavior: Report of the International Society for CNS Clinical Trials and Methodology Consensus Meeting.

    Science.gov (United States)

    Chappell, Phillip B; Stewart, Michelle; Alphs, Larry; DiCesare, Franco; DuBrava, Sarah; Harkavy-Friedman, Jill; Lim, Pilar; Ratcliffe, Sian; Silverman, Morton M; Targum, Steven D; Marder, Stephen R

    2017-06-01

    To develop consensus recommendations for assessment of suicidal ideation/suicidal behavior (SI/SB) in clinical trials. Stakeholders from academia, industry, regulatory agencies, National Institutes of Health, National Institute of Mental Health, and patient advocacy organizations participated in a consensus meeting that was sponsored by the International Society for CNS Clinical Trials and Methodology and held November 17-18, 2015. Prior to the meeting, teams of experts identified key areas of consensus and dissent related to SI/SB. The most critical issues were presented and discussed in the consensus meeting. Literature reviews and a pre-meeting survey were conducted. Findings were discussed in pre-meeting working group sessions and at the consensus meeting. Five pre-meeting working groups reviewed (1) nomenclature and classification schemes for SI/SB, (2) detection and assessment of SI/SB, (3) analysis of SI/SB data, (4) design of clinical trials for new treatments of SI/SB, and (5) public health approaches to SI/SB. A modification of the RAND/UCLA Appropriateness Method was used to combine review of scientific evidence with the collective views of experts and stakeholders to reach the final consensus statements. After discussion, all attendees voted using an electronic interactive audience response system. Areas of agreement and areas of continuing dissent were recorded. All 5 working groups agreed that a major barrier to advancement of the field of SI/SB research and the development of new treatments for SI/SB remains the lack of a universally accepted standardized nomenclature and classification system. Achieving alignment on definitions and classification of suicide-related phenomena is critical to improving the detection and assessment of SI/SB, the design of clinical trials for new treatments, and effective public health interventions. © Copyright 2017 Physicians Postgraduate Press, Inc.

  19. Mg Isotope Inter-Laboratory Comparison of Reference Materials from Earth-Surface Low-Temperature Environments

    OpenAIRE

    Shalev, Netta; Farkas, Juraj; Fietzke, Jan; Novak, Martin; Schuessler, Jan A.; Pogge von Strandmann, Philip A.E; Törber, Philip B.

    2018-01-01

    To enable quality control of measurement procedures for determinations of Mg isotope amount ratios, expressed as δ26Mg and δ25Mg values, in Earth-surface studies, the δ26Mg and δ25Mg values of eight reference materials (RMs) were determined by inter-laboratory comparison between five laboratories and considering published data, if available. These matrix RMs, including river water SLRS-5, spring water NIST SRM 1640a, Dead Sea brine DSW-1, dolomites JDo-1 and CRM 512, limestone CRM 513, soil N...

  20. Youden analysis of Karl Fischer titration data from an interlaboratory study determining water in animal feed, grain, and forage.

    Science.gov (United States)

    Jones, Frank E

    2005-01-01

    Data from a recent interlaboratory study of the determination of water (moisture) in animal feed, grain, and forage (plant tissue) by Karl Fischer titration were re-analyzed using Youden plots. The purpose was to show the unique ability these plots possess of separating random and systematic errors visually while providing numerical estimates of the precision and the systematic error of the method. Furthermore, the usefulness of the technique is underscored because AOAC INTERNATIONAL allows the use of matched pairs in collaborative studies to obtain estimates of repeatability and reproducibility.

  1. Interlaboratory outdoor stability studies of flexible roll-to-roll coated organic photovoltaic modules: Stability over 10,000 h

    DEFF Research Database (Denmark)

    Gevorgyan, Suren; Madsen, Morten Vesterager; Dam, Henrik Friis

    2013-01-01

    This work attempts to reveal the comparability issues related to outdoor testing procedures of organic photovoltaic (OPV) modules via studies of inter-laboratory long-term outdoor measurements of roll-to-roll coated flexible OPV modules (P3HT:PCBM, inverted architecture) in different geographic...... and measurement setups on the comparability of test results are analyzed. A strong link between the device temperature and performance is revealed, which is ascribed to the reaction of PEDOT:PSS layer with water. The estimation of the true performance of the modules by accommodation of variations in testing...

  2. Status Report of the Inter-Laboratory Task Force on Remote Operation

    Energy Technology Data Exchange (ETDEWEB)

    Phinney, Nan

    2001-12-13

    The next generation of particle accelerators will be major projects which may require a new mode of international and inter-laboratory collaboration. They are likely to be too costly to be funded by a single nation and too large to be built by a single laboratory. The tremendous technical challenge of a new facility requires a critical mass of highly qualified and experienced physicists and engineers. These experts are presently distributed among the major accelerator centers around the world and it is believed important to maintain and develop this broad base of expertise. The successful accelerator technology development of recent decades depended on extensive exchange of people with complementary technical skills. Therefore, it is desirable and probably necessary that several accelerator laboratories will participate in any future project. A consequence of a multi-laboratory project is that the accelerator will be located a considerable distance from most of the contributing institutions which design, build and operate it. These considerations led the International Committee for Future Accelerators to initiate a study on the general and technical implications of such a collaboration. Two task forces were formed in February 2000 to conduct this study and they were asked to prepare a report on a time scale of one year. The task force on Remote Operation included members from most of the major accelerator laboratories around the world with expertise on accelerator operation, controls software, communication technologies, hardware design and maintenance. The task force members gathered information from the experts at their own institutions and from available experience in other fields, particularly astronomy.

  3. Interlaboratory study of the ion source memory effect in 36Cl accelerator mass spectrometry

    Science.gov (United States)

    Pavetich, Stefan; Akhmadaliev, Shavkat; Arnold, Maurice; Aumaître, Georges; Bourlès, Didier; Buchriegler, Josef; Golser, Robin; Keddadouche, Karim; Martschini, Martin; Merchel, Silke; Rugel, Georg; Steier, Peter

    2014-06-01

    Understanding and minimization of contaminations in the ion source due to cross-contamination and long-term memory effect is one of the key issues for accurate accelerator mass spectrometry (AMS) measurements of volatile elements. The focus of this work is on the investigation of the long-term memory effect for the volatile element chlorine, and the minimization of this effect in the ion source of the Dresden accelerator mass spectrometry facility (DREAMS). For this purpose, one of the two original HVE ion sources at the DREAMS facility was modified, allowing the use of larger sample holders having individual target apertures. Additionally, a more open geometry was used to improve the vacuum level. To evaluate this improvement in comparison to other up-to-date ion sources, an interlaboratory comparison had been initiated. The long-term memory effect of the four Cs sputter ion sources at DREAMS (two sources: original and modified), ASTER (Accélérateur pour les Sciences de la Terre, Environnement, Risques) and VERA (Vienna Environmental Research Accelerator) had been investigated by measuring samples of natural 35Cl/37Cl-ratio and samples highly-enriched in 35Cl (35Cl/37Cl ∼ 999). Besides investigating and comparing the individual levels of long-term memory, recovery time constants could be calculated. The tests show that all four sources suffer from long-term memory, but the modified DREAMS ion source showed the lowest level of contamination. The recovery times of the four ion sources were widely spread between 61 and 1390 s, where the modified DREAMS ion source with values between 156 and 262 s showed the fastest recovery in 80% of the measurements.

  4. Multifactorial assessment and targeted intervention in nutritional status among the older adults: a randomized controlled trial: the Octabaix study.

    Science.gov (United States)

    Badia, Teresa; Formiga, Francesc; Ferrer, Assumpta; Sanz, Héctor; Hurtos, Laura; Pujol, Ramón

    2015-04-11

    Malnutrition is frequent among older people and is associated with morbi-mortality. The aim of the study is to assess the effectiveness of a multifactorial and multidisciplinary intervention in the nutritional status among the elderly. Randomized, single-blind, parallel-group, clinical trial conducted from January 2009 to December 2010 in seven primary health care centers in Baix Llobregat (Barcelona). Of 696 referred people, born in 1924, 328 subjects were randomized to an intervention group or a control group. The intervention model used an algorithm and was multifaceted for both the patients and their primary care providers. The main outcome was improvement in nutritional status assessed by Mini Nutritional Assessment (MNA). Data analyses were done by intention-to-treat. Two-year assessment was completed for 127 patients (77.4%) in the intervention group and 98 patients (59.7%) in the control group. In the adjusted linear mixed models for MNA, intervention showed no significant effect during all follow-up period with -0.21 (CI: - 0.96; 0.26). In subjects with nutritional risk (MNA ≤ 23.5/30) existed a tendency towards improvement in MNA score 1.13 (95% CI -0.48; 2.74) after 2 years. A universal multifactorial assessment and target intervention over a two year period in subjects at nutritional risk showed a tendency to improve nutrition but not in the rest of community-dwelling studied subjects. Cognitive impairment was an independent factor strongly associated with a decline in nutritional status. The clinical trial is registered as part of a US National Institutes of Health Clinical Trial: NCT01141166.

  5. Reactivity to smartphone-based ecological momentary assessment of depressive symptoms (MoodMonitor: protocol of a randomised controlled trial

    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 .

  6. Unannounced telephone pill counts for assessing varenicline adherence in a pilot clinical trial

    Directory of Open Access Journals (Sweden)

    Thompson N

    2011-09-01

    Full Text Available Nia Thompson1, Niaman Nazir1, Lisa Sanderson Cox1,2, Babalola Faseru1,2, Kathy Goggin3, Jasjit S Ahluwalia4, Nicole L Nollen1,21University of Kansas School of Medicine, Department of Preventive Medicine and Public Health, Kansas City, KS, USA; 2University of Kansas Cancer Center, Kansas City, KS, USA; 3University of Missouri-Kansas City, Department of Psychology, Kansas City, MO, USA; 4University of Minnesota Medical School, Department of Medicine and Center for Health Equity, Minneapolis, MN, USABackground: Despite consistent evidence linking smoking cessation pharmacotherapy adherence to better outcomes, knowledge about objective adherence measures is lacking and little attention is given to monitoring pharmacotherapy use in smoking cessation clinical trials.Objectives: To examine unannounced telephone pill counts as a method for assessing adherence to smoking cessation pharmacotherapy.Research design: Secondary data analysis of a randomized pilot study.Participants: 46 moderate-to-heavy (>10 cigarettes per day African-American smokers.Main measures: Smokers received 1 month of varenicline (Pfizer Global Pharmaceuticals, New York, NY in a pill box at baseline. Unannounced pill counts were completed by telephone 4 days prior to an in-person pill count conducted at Month 1. At both counts, each compartment of the pill box was opened and the number of remaining pills was recorded.Results: Participants were a mean age of 48 years (SD = 13, predominately female (59%, low income (60% < $1800 monthly family income, and smoked an average of 17 (SD = 7 cigarettes per day. A high degree of concordance was observed between the number of pills counted by phone and in-person (rs = 0.94, P < 0.001. Participants with discordant counts (n = 7 had lower varenicline adherence (mean [SD] = 77% [18%] vs 95% [9%], P < 0.0005, but reported better medication adherence in the past (1.0 [0.8] vs 2.8 [1.0], P < 0.0004 than participants with matching phone and in

  7. On modeling HIV and T cells in vivo: assessing causal estimators in vaccine trials.

    Directory of Open Access Journals (Sweden)

    W David Wick

    2006-06-01

    Full Text Available The first efficacy trials--named STEP--of a T cell vaccine against HIV/AIDS began in 2004. The unprecedented structure of these trials raised new modeling and statistical challenges. Is it plausible that memory T cells, as opposed to antibodies, can actually prevent infection? If they fail at prevention, to what extent can they ameliorate disease? And how do we estimate efficacy in a vaccine trial with two primary endpoints, one traditional, one entirely novel (viral load after infection, and where the latter may be influenced by selection bias due to the former? In preparation for the STEP trials, biostatisticians developed novel techniques for estimating a causal effect of a vaccine on viral load, while accounting for post-randomization selection bias. But these techniques have not been tested in biologically plausible scenarios. We introduce new stochastic models of T cell and HIV kinetics, making use of new estimates of the rate that cytotoxic T lymphocytes--CTLs; the so-called killer T cells--can kill HIV-infected cells. Based on these models, we make the surprising discovery that it is not entirely implausible that HIV-specific CTLs might prevent infection--as the designers explicitly acknowledged when they chose the endpoints of the STEP trials. By simulating thousands of trials, we demonstrate that the new statistical methods can correctly identify an efficacious vaccine, while protecting against a false conclusion that the vaccine exacerbates disease. In addition to uncovering a surprising immunological scenario, our results illustrate the utility of mechanistic modeling in biostatistics.

  8. Impact of clinical trials on neurosurgical practice: an assessment of case volume.

    Science.gov (United States)

    Simon, Scott D; Koyama, Tatsuki; Zacharia, Brad E; Schirmer, Clemens M; Cheng, Joseph S

    2015-04-01

    To evaluate the effect of important trials on the practice of neurosurgery. We hypothesized that evidence from trials addressing the management of intracranial aneurysms (International Subarachnoid Aneurysm Trial [ISAT]) and nontraumatic intracerebral hemorrhages (Surgical Trial in Intracerebral Hemorrhage [STICH]) and vertebral augmentation for osteoporotic vertebral body fractures had a significant impact on the frequency of the corresponding neurosurgical procedures. A Medicare administrative database was queried for corresponding Common Procedural Terminology codes and units billed per calendar year. The effects of ISAT and STICH were evaluated using a generalized linear model. The effect of the vertebral augmentation study was evaluated using a t test. After publication of ISAT in 2002, the rate of increase in proportion of cerebral aneurysms that were treated with embolization (Common Procedural Terminology code 61624) per year increased from 3.9% to 5.5% (P = 0.01). After publication of STICH in 2005, the number of craniotomies performed for intracerebral hematoma decreased from 2341 in 2002 to 1646 in 2011 (P = 0.03). After 2 publications in 2009, performance of vertebral augmentation decreased from a high of 99,961 in 2009 per year to 77,108 in 2013 (P = 0.002). Randomized clinical trials remain the gold standard in the medical community to demonstrate efficacy, but their true impact relies on rapid and extensive assimilation into everyday medical practice. However, the described methodology establishes a temporal relationship only and does not prove causation. Nonetheless, trends in procedural volume suggest that the results of these select randomized clinical trials had a significant effect on neurosurgical practice affecting Medicare patients within an interval of a few years. Copyright © 2015 Elsevier Inc. All rights reserved.

  9. Assessing the challenges of multi-scope clinical research sites: an example from NIH HIV/AIDS clinical trials networks.

    Science.gov (United States)

    Rosas, Scott R; Cope, Marie T; Villa, Christie; Motevalli, Mahnaz; Utech, Jill; Schouten, Jeffrey T

    2014-04-01

    Large-scale, multi-network clinical trials are seen as a means for efficient and effective utilization of resources with greater responsiveness to new discoveries. Formal structures instituted within the National Institutes of Health (NIH) HIV/AIDS Clinical Trials facilitate collaboration and coordination across networks and emphasize an integrated approach to HIV/AIDS vaccine, prevention and therapeutics clinical trials. This study examines the joint usage of clinical research sites as means of gaining efficiency, extending capacity, and adding scientific value to the networks. A semi-structured questionnaire covering eight clinical management domains was administered to 74 (62% of sites) clinical site coordinators at single- and multi-network sites to identify challenges and efficiencies related to clinical trials management activities and coordination with multi-network units. Overall, respondents at multi-network sites did not report more challenges than single-network sites, but did report unique challenges to overcome including in the areas of study prioritization, community engagement, staff education and training, and policies and procedures. The majority of multi-network sites reported that such affiliations do allow for the consolidation and cost-sharing of research functions. Suggestions for increasing the efficiency or performance of multi-network sites included streamlining standards and requirements, consolidating protocol activation methods, using a single cross-network coordinating centre, and creating common budget and payment mechanisms. The results of this assessment provide important information to consider in the design and management of multi-network configurations for the NIH HIV/AIDS Clinical Trials Networks, as well as others contemplating and promoting the concept of multi-network settings. © 2013 John Wiley & Sons Ltd.

  10. Clinical trials assessing ototopical agents in the treatment of pain associated with acute otitis media in children.

    Science.gov (United States)

    Wood, Daniel N; Nakas, Nermina; Gregory, Christopher W

    2012-09-01

    Otalgia (ear pain) is one of the characteristic symptoms and best predictor of acute otitis media (AOM) in children. Although oral pain medications are the current mainstay for the treatment of AOM-associated otalgia, ototopical agents have been investigated as an alternative treatment strategy. To permit review and assessment of this treatment modality, a systematic literature search was conducted to identify all randomized, controlled trials of ototopical agents. Four trials were identified, including those examining ototopical benzocaine in combination with antipyrine, lidocaine, tetracaine, and herbal extracts. Although the current available evidence suggests ototopical agents may be safe and effective, we conclude that further studies with more rigorous methodology are needed to conclusively demonstrate their utility in this setting. Copyright © 2012 Elsevier Ireland Ltd. All rights reserved.

  11. Statins but not aspirin reduce thrombotic risk assessed by thrombin generation in diabetic patients without cardiovascular events: the RATIONAL trial.

    Directory of Open Access Journals (Sweden)

    Alejandro Macchia

    Full Text Available The systematic use of aspirin and statins in patients with diabetes and no previous cardiovascular events is controversial. We sought to assess the effects of aspirin and statins on the thrombotic risk assessed by thrombin generation (TG among patients with type II diabetes mellitus and no previous cardiovascular events.Prospective, randomized, open, blinded to events evaluation, controlled, 2×2 factorial clinical trial including 30 patients randomly allocated to aspirin 100 mg/d, atorvastatin 40 mg/d, both or none. Outcome measurements included changes in TG levels after treatment (8 to 10 weeks, assessed by a calibrated automated thrombogram. At baseline all groups had similar clinical and biochemical profiles, including TG levels. There was no interaction between aspirin and atorvastatin. Atorvastatin significantly reduced TG measured as peak TG with saline (85.09±55.34 nmol vs 153.26±75.55 nmol for atorvastatin and control groups, respectively; p = 0.018. On the other hand, aspirin had no effect on TG (121.51±81.83 nmol vs 116.85±67.66 nmol, for aspirin and control groups, respectively; p = 0.716. The effects of treatments on measurements of TG using other agonists were consistent.While waiting for data from ongoing large clinical randomized trials to definitively outline the role of aspirin in primary prevention, our study shows that among diabetic patients without previous vascular events, statins but not aspirin reduce thrombotic risk assessed by TG.ClinicalTrials.gov NCT00793754.

  12. Recruitment and representativeness of blood donors in the INTERVAL randomised trial assessing varying inter-donation intervals.

    Science.gov (United States)

    Moore, Carmel; Bolton, Thomas; Walker, Matthew; Kaptoge, Stephen; Allen, David; Daynes, Michael; Mehenny, Susan; Sambrook, Jennifer; Watkins, Nicholas A; Miflin, Gail; Di Angelantonio, Emanuele; Ouwehand, Willem H; Roberts, David J; Danesh, John; Thompson, Simon G

    2016-09-20

    The interpretation of trial results can be helped by understanding how generalisable they are to the target population for which inferences are intended. INTERVAL, a large pragmatic randomised trial of blood donors in England, is assessing the effectiveness and safety of reducing inter-donation intervals. The trial recruited mainly from the blood service's static centres, which collect only about 10 % of whole-blood donations. Hence, the extent to which the trial's participants are representative of the general blood donor population is uncertain. We compare these groups in detail. We present the CONSORT flowchart from participant invitation to randomisation in INTERVAL. We compare the characteristics of those eligible and consenting to participate in INTERVAL with the general donor population, using the national blood supply 'PULSE' database for the period of recruitment. We compare the characteristics of specific groups of trial participants recruited from different sources, as well as those who were randomised versus those not randomised. From a total of 540,459 invitations, 48,725 donors were eligible and consented to participate in INTERVAL. The proportion of such donors varied from 1-22 % depending on the source of recruitment. The characteristics of those consenting were similar to those of the general population of 1.3 million donors in terms of ethnicity, blood group distribution and recent deferral rates from blood donation due to low haemoglobin. However, INTERVAL participants included more men (50 % versus 44 %), were slightly older (mean age 43.1 versus 42.3 years), included fewer new donors (3 % versus 22 %) and had given more donations over the previous 2 years (mean 3.3 versus 2.2) than the general donor population. Of the consenting participants, 45,263 (93 %) donors were randomised. Compared to those not randomised, the randomised donors showed qualitatively similar differences to those described above. There was broad similarity of

  13. 'PhysioDirect' telephone assessment and advice services for physiotherapy: protocol for a pragmatic randomised controlled trial

    Directory of Open Access Journals (Sweden)

    Hopper Cherida

    2009-08-01

    Full Text Available Abstract Background Providing timely access to physiotherapy has long been a problem for the National Health Service in the United Kingdom. In an attempt to improve access some physiotherapy services have introduced a new treatment pathway known as PhysioDirect. Physiotherapists offer initial assessment and advice by telephone, supported by computerised algorithms, and patients are sent written self-management and exercise advice by post. They are invited for face-to-face treatment only when necessary. Although several such services have been developed, there is no robust evidence regarding clinical and cost-effectiveness, nor the acceptability of PhysioDirect. Methods/Design This protocol describes a multi-centre pragmatic individually randomised trial, with nested qualitative research. The aim is to determine the effectiveness, cost-effectiveness, and acceptability of PhysioDirect compared with usual models of physiotherapy based on patients going onto a waiting list and receiving face-to-face care. PhysioDirect services will be established in four areas in England. Adult patients in these areas with musculoskeletal problems who refer themselves or are referred by a primary care practitioner for physiotherapy will be invited to participate in the trial. About 1875 consenting patients will be randomised in a 2:1 ratio to PhysioDirect or usual care. Data about outcome measures will be collected at baseline and 6 weeks and 6 months after randomisation. The primary outcome is clinical improvement at 6 months; secondary outcomes include cost, waiting times, time lost from work and usual activities, patient satisfaction and preference. The impact of PhysioDirect on patients in different age-groups and with different conditions will also be examined. Incremental cost-effectiveness will be assessed in terms of quality adjusted life years in relation to cost. Qualitative methods will be used to explore factors associated with the success or failure of

  14. Online assessment of ALS functional rating scale compares well to in-clinic evaluation: a prospective trial.

    Science.gov (United States)

    Maier, André; Holm, Teresa; Wicks, Paul; Steinfurth, Laura; Linke, Peter; Münch, Christoph; Meyer, Robert; Meyer, Thomas

    2012-02-01

    Self-assessment of symptom progression in chronic diseases is of increasing importance in clinical research, patient management and specialized outpatient care. Against this background, we developed a secure internet platform (ALShome.de) that allows online assessment of the revised ALS Functional Rating Scale (ALSFRS-R) and other established self-assessment questionnaires. We developed a secure and closed internet portal to assess patient reported outcomes. In a prospective, controlled and stratified study, patients conducted a web-based self-assessment of ALSFRS-R compared to on-site assessment. On-site and online assessments were compared at baseline (n = 127) and after 3.5 months (n = 81, 64%). Results showed that correlation between on-site evaluation and online testing of ALSFRS-R was highly significant (r = 0.96; p online vs. on-site) was excellent (mean interval, 8.8 days). The adherence to online rating was high; 75% of patients tested on-site completed a follow-up online visit (mean 3.5 months, SD 1.7). We conclude that online self-assessment of ALS severity complements the well-established face-to-face application of the ALSFRS-R during on-site visits. The results of our study support the use of online administration of ALSFRS-R within clinical trials and for managing the care of ALS patients.

  15. [Pharmaceutical involvement in academic clinical trials: Quality assessment of pharmaceutical manufacturing operations].

    Science.gov (United States)

    Gérard, C; Tall, M L; Reymond, E Boidi Trotti; Laleye, D; Hutasse, E; Retière, A-C; Dhelens, C; Pirot, F; Pivot, C

    2015-05-01

    For academic clinical trials, the hospital pharmacy may be required to perform the specific activity of preparing investigational drugs. With regards to such activity, and in light of the recent changes in the regulatory environment, the main objective of this study was to evaluate whether quality levels and traceability were in compliance with the applicable regulatory standards. In order to do so, two internal audits have been conducted, the first on the compliance of operations with existing regulatory standards and the second on the quality of traceability of the operations. The proportion of academic clinical trials is constantly growing and currently represents 41% of the total clinical trials in the establishment. An average of 29,000 therapeutic units of investigational drugs are prepared each year (84% under the form of capsules). An overall conformity level of 75% and 88% has been identified in the aforementioned audits, respectively. Such audits have also allowed for the identification of weaknesses in current practices as well as potential improvement areas to achieve better compliance. The hospital pharmacy can provide expertise for the preparation of specific dosage or drugs that are not available on the market. It also can be involved for the conception of appropriated packaging function of the study design. Results of audits encourage us to continue this activity with a satisfactory level of quality in accordance with the necessary requirements to ensure the safety of patients and the quality of clinical trials conducted. Copyright © 2014 Elsevier Masson SAS. All rights reserved.

  16. Assessment of Adverse Events in Protocols, Clinical Study Reports, and Published Papers of Trials of Orlistat

    DEFF Research Database (Denmark)

    Schroll, Jeppe Bennekou; Penninga, Elisabeth I; Gøtzsche, Peter C

    2016-01-01

    group were more severe. None of this was stated in the CSR or in the published paper. Our analysis was restricted to one drug tested in the mid-1990s; our results might therefore not be applicable for newer drugs. CONCLUSIONS: In the orlistat trials, we identified important disparities in the reporting...

  17. Assessing Impact and Bridging Methodological Divides: Randomized Trials in Countries Affected by Conflict

    Science.gov (United States)

    Burde, Dana

    2012-01-01

    Randomized trials have experienced a marked surge in endorsement and popularity in education research in the past decade. This surge reignited paradigm debates and spurred qualitative critics to accuse these experimental designs of eclipsing qualitative research. This article reviews a current iteration of this debate and examines two randomized…

  18. Selection of a method for scoring radiographs for ankylosing spondylitis clinical trials, by the Assessment in Ankylosing Spondylitis Working Group and OMERACT

    NARCIS (Netherlands)

    van der Heijde, Désirée; Landewé, Robert

    2005-01-01

    Radiographs are important for assessing structural damage in patients with ankylosing spondylitis (AS); this technology was selected by the international ASsessment in Ankylosing Spondylitis (ASAS) Working Group as an important domain for assessing outcome in clinical trials. The selection of a

  19. REIMEP-22 inter-laboratory comparison. ''U Age Dating - determination of the production date of a uranium certified test sample''

    Energy Technology Data Exchange (ETDEWEB)

    Venchiarutti, Celia; Richter, Stephan; Jakopic, Rozle; Aregbe, Yetunde [European Commission, Joint Research Centre (JRC), Geel (Belgium). Institute for Reference Materials and Measurements (IRMM); Varga, Zsolt; Mayer, Klaus [European Commission, Joint Research Centre (JRC), Karlsruhe (Germany). Institute for Transuranium Elements (ITU)

    2015-07-01

    The REIMEP-22 inter-laboratory comparison aimed at determining the production date of a uranium certified test sample (i.e. the last chemical separation date of the material). Participants in REIMEP-22 on ''U Age Dating - Determination of the production date of a uranium certified test sample'' received one low-enriched 20 mg uranium sample for mass spectrometry measurements and/or one 50 mg uranium sample for a-spectrometry measurements, with an undisclosed value for the production date. They were asked to report the isotope amount ratios n({sup 230}Th)/n({sup 234}U) for the 20 mg uranium sample and/or the activity ratios A({sup 230}Th)/A({sup 234}U) for the 50 mg uranium sample in addition to the calculated production date of the certified test samples with its uncertainty. Reporting of the {sup 231}Pa/{sup 235}U ratio and the respective calculated production date was optional. Eleven laboratories reported results in REIMEP-22. Two of them reported results for both the 20 mg and 50 mg uranium certified test samples. The measurement capability of the participants was assessed against the independent REIMEP-22 reference value by means of z- and zeta-scores in compliance with ISO 13528:2005. Furthermore a performance assessment criterion for acceptable uncertainty was applied to evaluate the participants' results. In general, the REIMEP-22 participants' results were satisfactory. This confirms the analytical capabilities of laboratories to determine accurately the age of uranium materials with low amount of ingrown thorium (young certified test sample). The Joint Research Centre of the European Commission (EC-JRC) organised REIMEP-22 in parallel to the preparation and certification of a uranium reference material certified for the production date (IRMM-1000a and IRMM-1000b).

  20. A comparative interlaboratory study on photocatalytic activity of commercial ZnO and CeO2 nanoparticles

    Science.gov (United States)

    Yin, Hong; Tsuzuki, Takuya; Millington, Keith R.; Casey, Philip S.

    2014-10-01

    Photocatalytic activity (PCA) was one of a number of physicochemical end points identified by the Organisation for Economic Cooperation and Development (OECD) as relevant to environmental safety and human health as part of their Sponsorship Programme for the Testing of Manufactured Nanomaterial. Photoactive surfaces can produce reactive oxygen species including free radicals which have the potential to cause oxidative stress in tissue or even oxidative damage to DNA. Here we report a study that involved three laboratories in Australia that independently characterised the PCA of commercially available ZnO and CeO2 NPs provided by the OECD programme. This inter-laboratory comparison found that PCA is a stable characteristic of NPs which was insensitive to variations in interlaboratory protocols and with ZnO NPs being more photoactive (by an order of magnitude) than CeO2 NPs. Comparisons were made between NPs of different sizes and the effect of the presence or absence of a surface coating on PCA. Because the competition between surface and volume effects determined PCA, a critical particle size was found for CeO2 NPs to achieve maximum PCA. The presence of a surface coating appeared to significantly mitigate, but not eliminate PCA.

  1. Guidelines for time-to-event end point definitions in breast cancer trials: results of the DATECAN initiative (Definition for the Assessment of Time-to-event Endpoints in CANcer trials)†.

    Science.gov (United States)

    Gourgou-Bourgade, S; Cameron, D; Poortmans, P; Asselain, B; Azria, D; Cardoso, F; A'Hern, R; Bliss, J; Bogaerts, J; Bonnefoi, H; Brain, E; Cardoso, M J; Chibaudel, B; Coleman, R; Cufer, T; Dal Lago, L; Dalenc, F; De Azambuja, E; Debled, M; Delaloge, S; Filleron, T; Gligorov, J; Gutowski, M; Jacot, W; Kirkove, C; MacGrogan, G; Michiels, S; Negreiros, I; Offersen, B V; Penault Llorca, F; Pruneri, G; Roche, H; Russell, N S; Schmitt, F; Servent, V; Thürlimann, B; Untch, M; van der Hage, J A; van Tienhoven, G; Wildiers, H; Yarnold, J; Bonnetain, F; Mathoulin-Pélissier, S; Bellera, C; Dabakuyo-Yonli, T S

    2015-05-01

    Using surrogate end points for overall survival, such as disease-free survival, is increasingly common in randomized controlled trials. However, the definitions of several of these time-to-event (TTE) end points are imprecisely which limits interpretation and cross-trial comparisons. The estimation of treatment effects may be directly affected by the definitions of end points. The DATECAN initiative (Definition for the Assessment of Time-to-event Endpoints in CANcer trials) aims to provide recommendations for definitions of TTE end points. We report guidelines for randomized cancer clinical trials (RCTs) in breast cancer. A literature review was carried out to identify TTE end points (primary or secondary) reported in publications of randomized trials or guidelines. An international multidisciplinary panel of experts proposed recommendations for the definitions of these end points based on a validated consensus method that formalize the degree of agreement among experts. Recommended guidelines for the definitions of TTE end points commonly used in RCTs for breast cancer are provided for non-metastatic and metastatic settings. The use of standardized definitions should facilitate comparisons of trial results and improve the quality of trial design and reporting. These guidelines could be of particular interest to those involved in the design, conducting, reporting, or assessment of RCT. © The Author 2015. Published by Oxford University Press on behalf of the European Society for Medical Oncology. All rights reserved. For permissions, please email: journals.permissions@oup.com.

  2. Assessing Clinical Research Capacity in Vietnam: A Framework for Strengthening Capability for Clinical Trials in Developing Countries.

    Science.gov (United States)

    Kagan, Jonathan; Giang, Dao Duc; Iademarco, Michael F; Phung, Van Tt; Lau, Chuen-Yen; Quang, Nguyen Ngo

    2016-01-01

    Although improving health systems promises important benefits, most developing nations lack the resources to support nationally driven clinical research. Strengthened clinical research capacity can advance national health goals by supporting greater autonomy in aligning research with national priorities. From March through June 2010, we assessed six elements of clinical research capacity in Vietnam: research agenda; clinical investigators and biostatisticians; donors and sponsors; community involvement; scientific, ethical, safety, and quality oversight; and clinical research institutions. Assessments were drawn from interviews with investigators, Ministry of Health staff members, nongovernment organizations, and U.S. Mission staff members, and document review. Observations and recommendations were shared with collaborators. Reassessment in 2015 found growth in the number of clinical trials, improved regulation in human subjects protection and community engagement, and modest advances in research agenda setting. Training and investment in institutions remain challenging. A framework for assessing clinical research capacity can affirm strengths and weaknesses and guide the coordination of capacity-building efforts.

  3. Assessment of Adverse Events in Protocols, Clinical Study Reports, and Published Papers of Trials of Orlistat: A Document Analysis.

    Directory of Open Access Journals (Sweden)

    Jeppe Bennekou Schroll

    2016-08-01

    Full Text Available Little is known about how adverse events are summarised and reported in trials, as detailed information is usually considered confidential. We have acquired clinical study reports (CSRs from the European Medicines Agency through the Freedom of Information Act. The CSRs describe the results of studies conducted as part of the application for marketing authorisation for the slimming pill orlistat. The purpose of this study was to study how adverse events were summarised and reported in study protocols, CSRs, and published papers of orlistat trials.We received the CSRs from seven randomised placebo controlled orlistat trials (4,225 participants submitted by Roche. The CSRs consisted of 8,716 pages and included protocols. Two researchers independently extracted data on adverse events from protocols and CSRs. Corresponding published papers were identified on PubMed and adverse event data were extracted from this source as well. All three sources were compared. Individual adverse events from one trial were summed and compared to the totals in the summary report. None of the protocols or CSRs contained instructions for investigators on how to question participants about adverse events. In CSRs, gastrointestinal adverse events were only coded if the participant reported that they were "bothersome," a condition that was not specified in the protocol for two of the trials. Serious adverse events were assessed for relationship to the drug by the sponsor, and all adverse events were coded by the sponsor using a glossary that could be updated by the sponsor. The criteria for withdrawal due to adverse events were in one case related to efficacy (high fasting glucose led to withdrawal, which meant that one trial had more withdrawals due to adverse events in the placebo group. Finally, only between 3% and 33% of the total number of investigator-reported adverse events from the trials were reported in the publications because of post hoc filters, though six of

  4. Rationale and design of a randomized trial to assess the safety and efficacy of MultiPoint Pacing (MPP) in cardiac resynchronization therapy: The MPP Trial.

    Science.gov (United States)

    Tomassoni, Gery; Baker, James; Corbisiero, Raffaele; Love, Charles; Martin, David; Sheppard, Robert; Worley, Seth J; Lee, Kwangdeok; Niazi, Imran

    2017-11-01

    Although the majority of Class III congestive heart failure (HF) patients treated with cardiac resynchronization therapy (CRT) show a clinical benefit, up to 40% of patients do not respond to CRT. This paper reports the design of the MultiPoint Pacing (MPP) trial, a prospective, randomized, double-blind, controlled study to evaluate the safety and efficacy of CRT using MPP compared to standard biventricular (Bi-V) pacing. A maximum of 506 patients with a standard CRT-D indication will be enrolled at up to 50 US centers. All patients will be implanted with a CRT-D system (Quartet LV lead Model 1458Q with a Quadra CRT-D, Abbott) that can deliver both MPP and Bi-V pacing. Standard Bi-V pacing will be activated at implant. At 3 months postimplant, patients in whom the echocardiographic parameters during MPP are equal or better than during Bi-V pacing are randomized (1:1) to either an MPP or Bi-V arm. The primary safety endpoint is freedom from system-related complications at 9 months. Each patient's response to CRT will be evaluated using a heart-failure clinical composite score, consisting of a change in NYHA functional class, patient global assessment score, HF events, and cardiovascular death. The primary efficacy endpoint is the proportion of responders in the MPP arm compared with the Bi-V arm between 3 and 9 months. This trial seeks to evaluate whether MPP via a single quadripolar LV lead improves hemodynamic and clinical responses to CRT, both in clinical responders and nonresponders. © 2017 Wiley Periodicals, Inc.

  5. Telephone-based assessments to minimize missing data in longitudinal depression trials: a project IMPACTS study report.

    Science.gov (United States)

    Claassen, Cindy; Kurian, Ben; Trivedi, Madhukar H; Grannemann, Bruce D; Tuli, Ekta; Pipes, Ronny; Preston, Anne Marie; Flood, Ariell

    2009-01-01

    Missing data in clinical efficacy and effectiveness trials continue to be a major threat to the validity of study findings. The purpose of this report is to describe methods developed to ensure completion of outcome assessments with public mental health sector subjects participating in a longitudinal, repeated measures study for the treatment of major depressive disorder. We developed longitudinal assessment procedures that included telephone-based clinician interviews in order to minimize missing data commonly encountered with face-to-face assessment procedures. A pre-planned, multi-step strategy was developed to ensure completeness of data collection. The procedure included obtaining multiple pieces of patient contact information at baseline, careful education of both staff and patients concerning the purpose of assessments, establishing good patient rapport, and finally being flexible and persistent with phone appointments to ensure the completion of telephone-based follow-up assessments. A well-developed administrative and organizational structure was also put in place prior to study implementation. The assessment completion rate for the primary outcome for 310 of 504 subjects who enrolled and completed 52 weeks (at the time of manuscript) of telephone-based follow-up assessments was 96.8%. By utilizing telephone-based follow-up procedures and adapting our easy-to-use pre-defined multi-step approach, researchers can maximize patient data retention in longitudinal studies.

  6. Telephone-based Assessments to Minimize Missing Data in Longitudinal Depression Trials: A Project IMPACTS Study Report

    Science.gov (United States)

    Claassen, Cindy; Kurian, Ben; Trivedi, Madhukar H.; Grannemann, Bruce D.; Tuli, Ekta; Pipes, Ronny; Preston, Anne Marie; Flood, Ariell

    2012-01-01

    Purpose Missing data in clinical efficacy and effectiveness trials continue to be a major threat to the validity of study findings. The purpose of this report is to describe methods developed to ensure completion of outcome assessments with public mental health sector subjects participating in a longitudinal, repeated measures study for the treatment of major depressive disorder. We developed longitudinal assessment procedures that included telephone-based clinician interviews in order to minimize missing data commonly encountered with face-to-face assessment procedures. Methods A pre-planned, multi-step strategy was developed to ensure completeness of data collection. The procedure included obtaining multiple pieces of patient contact information at baseline, careful education of both staff and patients concerning the purpose of assessments, establishing good patient rapport, and finally being flexible and persistent with phone appointments to ensure the completion of telephone-based follow-up assessments. A well-developed administrative and organizational structure was also put in place prior to study implementation. Results The assessment completion rate for the primary outcome for 310 of 504 subjects who enrolled and completed 52 weeks (at the time of manuscript) of telephone-based follow-up assessments was 96.8%. Conclusion By utilizing telephone-based follow-up procedures and adapting our easy-to-use pre-defined multi-step approach, researchers can maximize patient data retention in longitudinal studies. PMID:18761427

  7. Versailles Project on Advanced Materials and Standards Interlaboratory Study on Measuring the Thickness and Chemistry of Nanoparticle Coatings Using XPS and LEIS

    NARCIS (Netherlands)

    Belsey, N.A.; Cant, D.J.H.; Minelli, C.; Araujo, J.R.; Bock, B.; Brüner, P.; Castner, D.G.; Ceccone, C.; Counsell, J.D.P.; Dietrich, P.M.; Engelhard, M.H.; Fearn, S.; Galhardo, C.E.; Kalbe, H.; Kim, J.W.; Lartundo-Rojas, L.; Luftman, H.S.; Nunney, T.S.; Pseiner, J.; Smith, E.F.; Spampinato, V.; Sturm, Jacobus Marinus; Thomas, A.G.; Treacy, J.P.W.; Veith, L.; Wagstaffe, M.; Wang, H.; Wang, M..; Wang, Y.C.; Werner, W.; Yang, L.; Shard, A.G.

    2016-01-01

    We report the results of a Versailles Project on Advanced Materials and Standards (VAMAS) interlaboratory study on the measurement of the shell thickness and chemistry of nanoparticle coatings. Peptide-coated gold particles were supplied to laboratories in two forms: a colloidal suspension in pure

  8. TOF-SIMS investigation of degradation pathways occurring in a variety of organic photovoltaic devices – the ISOS-3 inter-laboratory collaboration

    DEFF Research Database (Denmark)

    Andreasen, Birgitta; Tanenbaum, David; Hermenau, Martin

    2012-01-01

    The present work is the fourth (and final) contribution to an inter-laboratory collaboration that was planned at the 3rd International Summit on Organic Photovoltaic Stability (ISOS-3). The collaboration involved six laboratories capable of producing seven distinct sets of OPV devices that were d...

  9. INTERLABORATORY STUDY OF A THERMOSPRAY-LIQUID CHROMATOGRAPHIC/MASS SPECTROMETRIC METHOD FOR SELECTED N-METHYL CARBAMATES, N-METHYL CARBAMOYLOXIMES, AND SUBSTITUTED UREA PESTICIDES

    Science.gov (United States)

    A thermospray-liquid chromatographic/mass spectrometric (TS-LC/MS) method was evaluated in an interlaboratory study for determining 3 N-methyl carbamates (bendiocarb, carbaryl, and carbofuran), 3-N-methyl carbamoyloximes (aldicarb, methomyl, and oxamyl), 2 substituted urea pestic...

  10. Round-Robin Studies on Roll-Processed ITO-free Organic Tandem Solar Cells Combined with Inter-Laboratory Stability Studies

    DEFF Research Database (Denmark)

    Livi, Francesco; Søndergaard, Roar R.; Andersen, Thomas Rieks

    2015-01-01

    Roll-processed, indium tin oxide (ITO)-free, flexible, organic tandem solar cells and modules have been realized and used in round-robin studies as well as in parallel inter-laboratory stability studies. The tandem cells/modules show no significant difference in comparison to their single...

  11. Inter-laboratory evaluation of three flagellin PCR/RFLP methods for typing Campylobacter jejuni and C-coli: the CAMPYNET experience

    DEFF Research Database (Denmark)

    Harrington, Clare S.; Moran, L.; Ridley, A.M.

    2003-01-01

    Aims: To compare typeability, discriminatory ability, and inter-laboratory reproducibility of three flagellin PCR/RFLP(fla typing) methods previously described for Campylobacter. Methods and Results: The sample set(n = 100) was diverse, including both C. jejuni (n = 85) and C. coli (n = 15). Two...

  12. Assessment of the content reporting for therapeutic exercise interventions among existing randomized controlled trials on knee osteoarthritis.

    Science.gov (United States)

    O'Neil, Jennifer; McEwen, Daniel; Del Bel, Michael J; Jo, Donguk; Thevenot, Odette; MacKiddie, Olivia S; Brosseau, Lucie

    2018-03-01

    Purpose/Rationale: Physical exercise interventions for the management of knee osteoarthritis are well known to be effective and accessible forms of rehabilitation and symptom management. However, without adequate reporting of these interventions, accurate replication and clinical use is negatively impacted. The main objective of this article was to assess content reporting using The Consensus on Exercise Reporting Template list and 2016 American College of Sports Medicine guidelines among moderate- to high-quality exercise interventions randomized controlled trials (total score of ≥6/10 on the PEDro scale) involving individuals with knee osteoarthritis. The Consensus on Exercise Reporting Template mean total score for all 47 included randomized controlled trials was 4.42 out of 19, demonstrating generally low quality of reporting. The Consensus on Exercise Reporting Template list and the 2016 American College of Sports Medicine guidelines scores were moderately correlated (based on 95% confidence interval, intraclass correlation coefficient = 0.508) for aerobic interventions only. The content analysis of exercise interventions in knee osteoarthritis demonstrated low scores for moderate- to high-quality trials. Improved standardized reporting is recommended to ensure knowledge transfer and replication of effective exercise programs for individuals with knee osteoarthritis.

  13. A trial burn of rape straw and whole crops harvested for energy use to assess efficiency implications

    Energy Technology Data Exchange (ETDEWEB)

    Newman, R.

    2003-11-01

    Increased biomass utilisation and alternatives to cereal straw such as oil seed rape (OSR) straw will be necessary to achieve the Government's renewable energy targets. This report describes the results of a study to investigate the technical and economic feasibility of burning OSR straw and whole crops in an existing biomass power plant operated by EPR Ely Ltd in comparison with conventional cereal straw. Suitable quantities of bales of each fuel were provided for the combustion trials by Anglian Straw Ltd. Three trials were conducted: one using wheat-based cereal straw; one using 92% OSR; and one using 65% whole crop fuel. The availability of OSR straw and whole crop in Eastern England for use as fuel was also determined. Plant performance and stack emissions were evaluated and samples of delivered crop samples, bottom ash and fly ash from each trial were analysed. The parameters against which performance was assessed included: ease of handling and conveying; ease of chopping; ease of entry into the combustion chamber; furnace temperature profile; steam and electricity production rate; plant chimney emissions; ash collection and removal; operating stability; sustainability; and fuel availability.

  14. Assessing the quality of reports about randomized controlled trials of scalp acupuncture treatment for vascular dementia.

    Science.gov (United States)

    You, Young-Nim; Cho, Myung-Rae; Park, Ju-Hyung; Park, Gwang-Cheon; Song, Min-Yeong; Choi, Jin-Bong; Na, Chang-Su; Han, Jae-Young; Shin, Jeong-Cheol; Kim, Jae-Hong

    2017-05-02

    This study aimed to evaluate the quality of reports about randomized controlled trials (RCTs) of scalp acupuncture (SA) for the treatment of vascular dementia (VD). A systematic search of reports published through to December 2015 was performed in eight databases. The quality of RCTs that used SA as an intervention for VD was evaluated based on the 2010 Consolidated Standards for Reporting of Trials (CONSORT) and 2010 Standards for Reporting Interventions in Controlled Trials of Acupuncture (STRICTA) guidelines. Thirteen items from the CONSORT guideline were scored to give an overall quality score (OQS, range 0-13), and a combined key methodological index score (MIS) (range 0-5) of five key methodological items was measured. The OQS of 17 items from the STRICTA guideline (range 0-17) was also measured. In total, 26 reports were evaluated. The median OQS based on the CONSORT guideline was 8 (minimum 5, maximum 11), and "trial design," "sample size," "ancillary analyses," and "harms" had a positive rate of less than 10%. The median MIS was 2 (minimum 0, maximum 5), with "allocation concealment and implementation," "blinding," and "intent-to-treat analysis" having a positive rate of less than 15%. The median OQS based on the STRICTA guideline was 12 (minimum 8, maximum 14), with "extent to which treatment was varied (1c)," "number of needle insertions per subject per session (2a)," and "setting and context of treatment (4b)" having a positive rate of less than 10%. The overall quality of reports on RCTs of SA treatment for VD was moderate to low. The quality of methodological items was markedly lower than that of other items. The CONSORT and STRICTA guidelines should be used more frequently to standardize the quality of RCT reports of SA treatment for VD.

  15. A phase II clinical trial to assess the safety of clonidine in acute organophosphorus pesticide poisoning

    Directory of Open Access Journals (Sweden)

    Karunatilake Harindra

    2009-08-01

    Full Text Available Abstract Background An estimated 2–3 million people are acutely poisoned by organophosphorus pesticides each year, mostly in the developing world. There is a pressing need for new affordable antidotes and clonidine has been shown to be effective in animal studies. Our aim was to determine the safety of clonidine given as an antidote in adult patients presenting with signs or symptoms of acute organophosphate ingestion. Methods This study was a dose finding, open-label, multicentre, phase II trial. Forty eight patients with acute organophosphate poisoning were randomized to receive either clonidine or placebo: Four to receive placebo and twelve to receive clonidine at each dose level. The first dose level was an initial loading dose of 0.15 mg followed by an infusion of 0.5 mg of clonidine over 24 hours. The initial loading dose was increased to 0.3 mg, 0.45 and 0.6 mg. at all dosing levels however the subsequent infusion remained at 0.5 mg of clonidine over 24 hours. Results The baseline characteristics of both groups were similar. The trial was stopped after completion of the 3rd dosing level. At the 1st and 2nd dosing level there were no reported adverse drug reactions. At the 3rd dosing level 5 patients (42% developed significant hypotension during clonidine treatment that responded to intravenous fluids. There were no statistical differences in ventilation rate, pre and post GCS, and mortality rates over all levels. Conclusion Our findings suggest use of moderate doses of clonidine in acute organophosphate poisoning can be used without causing frequent clinical problems but that higher doses are associated with a high incidence of hypotension requiring intervention. Further studies are needed to study the efficacy of clonidine as an antidote in organophosphate poisoning. Trial registration Current Controlled Trial ISRCTN89917816.

  16. Investigation of the Intra- and Interlaboratory Reproducibility of a Small Scale Standardized Supersaturation and Precipitation Method.

    Science.gov (United States)

    Plum, Jakob; Madsen, Cecilie M; Teleki, Alexandra; Bevernage, Jan; da Costa Mathews, Claudia; Karlsson, Eva M; Carlert, Sara; Holm, Rene; Müller, Thomas; Matthews, Wayne; Sayers, Alice; Ojala, Krista; Tsinsman, Konstantin; Lingamaneni, Ram; Bergström, Christel As; Rades, Thomas; Müllertz, Anette

    2017-12-04

    The high number of poorly water-soluble compounds in drug development has increased the need for enabling formulations to improve oral bioavailability. One frequently applied approach is to induce supersaturation at the absorptive site, e.g., the small intestine, increasing the amount of dissolved compound available for absorption. However, due to the stochastic nature of nucleation, supersaturating drug delivery systems may lead to inter- and intrapersonal variability. The ability to define a feasible range with respect to the supersaturation level is a crucial factor for a successful formulation. Therefore, an in vitro method is needed, from where the ability of a compound to supersaturate can be defined in a reproducible way. Hence, this study investigates the reproducibility of an in vitro small scale standardized supersaturation and precipitation method (SSPM). First an intralaboratory reproducibility study of felodipine was conducted, after which seven partners contributed with data for three model compounds; aprepitant, felodipine, and fenofibrate, to determine the interlaboratory reproducibility of the SSPM. The first part of the SSPM determines the apparent degrees of supersaturation (aDS) to investigate for each compound. Each partner independently determined the maximum possible aDS and induced 100, 87.5, 75, and 50% of their determined maximum possible aDS in the SSPM. The concentration-time profile of the supersaturation and following precipitation was obtained in order to determine the induction time (t ind ) for detectable precipitation. The data showed that the absolute values of t ind and aDS were not directly comparable between partners, however, upon linearization of the data a reproducible rank ordering of the three model compounds was obtained based on the β-value, which was defined as the slope of the ln(t ind ) versus ln(aDS) -2 plot. Linear regression of this plot showed that aprepitant had the highest β-value, 15.1, while felodipine and

  17. The role of radiation therapy in pediatric oncology as assessed by cooperative clinical trials

    International Nuclear Information System (INIS)

    D'Angio, G.J.

    1985-01-01

    Major advances have been made in pediatric oncology, and many are due to the advent of the cooperative clinical trial. This important research tool was originally developed for the testing of various therapeutic strategies for the management of children with acute leukemia. Such trials were eminently successful, as the consistently better long-term survival rates for children with this hitherto uniformly lethal disease can attest. The method soon found favor for the investigation of patients with so-called solid tumors. These trails were originally concerned with the elucidation of the value of various chemotherapeutic agents. Radiation therapists soon became involved, however, and this discipline became more heavily represented in study design and data analyses. Much radiation therapy information has been gained, some through prospective, randomized clinical investigations and some through retrospective reviews of roentgen therapy as it was employed in protocols accenting other aspects of care. Voluminous, important radiation therapy data have been deduced through the latter retrospective kinds of analyses, but this review will be confined largely to the published results of prospective, randomized cooperative clinical trials where radiation therapy was a governing variable. Certain investigations of historical interest will also be cited together with other results that established important principles even though not so rigorous in design

  18. Caries clinical trial methods for the assessment of oral care products in the 21st century.

    Science.gov (United States)

    Ellwood, R P; Gomez, J; Goma, J; Pretty, I A

    2012-09-01

    Traditionally, caries clinical trials of oral care products have focused on the prevention of caries in children and adolescents at the "cavitation" level. Because of a general reduction in caries incidence and the use of positive control comparators, studies have grown both in size and duration to improve statistical power. Currently, they tend to be of 2 to 3 years' duration, with up to 2,000 high-risk individuals per group. During the past decade, there has been a shift in emphasis from a restorative approach to the treatment of dental caries to a therapeutic approach focused on the remineralization of early caries lesions. However, caries clinical trials of oral care products have not often reflected this paradigm change. This manuscript reviews alternative caries clinical trial methods for oral care products. It is concluded that methods focused on the detection and monitoring of enamel caries and root caries, by visual approaches such as ICDAS and instrumental methods such as QLF, Diagnodent, and Electrical Caries Monitors, provide viable alternatives to traditional methods. In particular, such approaches more accurately reflect the modes of action of many therapeutic agents and formulations and may reduce the cost and duration of product innovation.

  19. Ezetimibe for the treatment of nonalcoholic steatohepatitis: assessment by novel magnetic resonance imaging and magnetic resonance elastography in a randomized trial (MOZART trial).

    Science.gov (United States)

    Loomba, Rohit; Sirlin, Claude B; Ang, Brandon; Bettencourt, Ricki; Jain, Rashmi; Salotti, Joanie; Soaft, Linda; Hooker, Jonathan; Kono, Yuko; Bhatt, Archana; Hernandez, Laura; Nguyen, Phirum; Noureddin, Mazen; Haufe, William; Hooker, Catherine; Yin, Meng; Ehman, Richard; Lin, Grace Y; Valasek, Mark A; Brenner, David A; Richards, Lisa

    2015-04-01

    Ezetimibe inhibits intestinal cholesterol absorption and lowers low-density lipoprotein cholesterol. Uncontrolled studies have suggested that it reduces liver fat as estimated by ultrasound in nonalcoholic steatohepatitis (NASH). Therefore, we aimed to examine the efficacy of ezetimibe versus placebo in reducing liver fat by the magnetic resonance imaging-derived proton density-fat fraction (MRI-PDFF) and liver histology in patients with biopsy-proven NASH. In this randomized, double-blind, placebo-controlled trial, 50 patients with biopsy-proven NASH were randomized to either ezetimibe 10 mg orally daily or placebo for 24 weeks. The primary outcome was a change in liver fat as measured by MRI-PDFF in colocalized regions of interest within each of the nine liver segments. Novel assessment by two-dimensional and three-dimensional magnetic resonance elastography was also performed. Ezetimibe was not significantly better than placebo at reducing liver fat as measured by MRI-PDFF (mean difference between the ezetimibe and placebo arms -1.3%, P = 0.4). Compared to baseline, however, end-of-treatment MRI-PDFF was significantly lower in the ezetimibe arm (15%-11.6%, P < 0.016) but not in the placebo arm (18.5%-16.4%, P = 0.15). There were no significant differences in histologic response rates, serum alanine aminotransferase and aspartate aminotransferase levels, or longitudinal changes in two-dimensional and three-dimensional magnetic resonance elastography-derived liver stiffness between the ezetimibe and placebo arms. Compared to histologic nonresponders (25/35), histologic responders (10/35) had a significantly greater reduction in MRI-PDFF (-4.35 ± 4.9% versus -0.30 ± 4.1%, P < 0.019). Ezetimibe did not significantly reduce liver fat in NASH. This trial demonstrates the application of colocalization of MRI-PDFF-derived fat maps and magnetic resonance elastography-derived stiffness maps of the liver before and after treatment to noninvasively assess treatment

  20. Comprehensive safety assessment of a human inactivated diploid enterovirus 71 vaccine based on a phase III clinical trial.

    Science.gov (United States)

    Zhang, Wei; Kong, Yujia; Jiang, Zhiwei; Li, Chanjuan; Wang, Ling; Xia, Jielai

    2016-04-02

    Human enterovirus 71 (EV71) is a causative agent of hand, foot, and mouth disease (HFMD). In a previous phase III trial in children, a human diploid cell-based inactivated EV71 vaccine elicited EV71 specific immune responses and protection against EV71 associated HFMD. This study aimed to assess the factors influencing the severity of adverse events observed in this previous trial. This was a randomized, double-blinded, placebo-controlled, phase III clinical trial of a human diploid vaccine carried out in 12,000 children in Guangxi Zhuang Autonomous Region, China (ClinicalTrials.gov: NCT01569581). Solicited events were recorded for 7 days and unsolicited events were reported for 28 days after each injection. Age trend analysis of adverse reaction was conducted in each treatment group. Multiple logistic regression models were built to identify factors influencing the severity of adverse reactions. Fewer solicited adverse reactions were observed in older participants within the first 7 days after vaccination (P < 0.0001), except local pain and pruritus. More severe adverse reactions were observed after the initial injection than after the booster injection. Serious cold or respiratory tract infections (RTI) were observed more often in children aged 6-36 months than in older children. Only the severity of local swelling was associated with body mass index. Children with throat discomfort before injection had a higher risk of serious cold or RTI. These results indicated that the human diploid cell-based vaccine achieved a satisfactory safety profile.

  1. A tailored, supportive care intervention using systematic assessment designed for people with inoperable lung cancer: a randomised controlled trial.

    Science.gov (United States)

    Schofield, Penelope; Ugalde, Anna; Gough, Karla; Reece, John; Krishnasamy, Meinir; Carey, Mariko; Ball, David; Aranda, Sanchia

    2013-11-01

    People with inoperable lung cancer experience higher levels of distress, more unmet needs and symptoms than other cancer patients. There is an urgent need to test innovative approaches to improve psychosocial and symptom outcomes in this group. This study tested the hypothesis that a tailored, multidisciplinary supportive care programme based on systematic needs assessment would reduce perceived unmet needs and distress and improve quality of life. A randomised controlled trial design was used. The tailored intervention comprised two sessions at treatment commencement and completion. Sessions included a self-completed needs assessment, active listening, self-care education and communication of unmet psychosocial and symptom needs to the multidisciplinary team for management and referral. Outcomes were assessed with the Needs Assessment for Advanced Lung Cancer Patients, Hospital Anxiety and Depression Scale, Distress Thermometer and European Organization of Research and Treatment of Cancer Quality of Life Q-C30 V2.0. One hundred and eight patients with a diagnosis of inoperable lung or pleural cancer (including mesothelioma) were recruited from a specialist facility before the trial closed prematurely (original target 200). None of the primary contrasts of interest were significant (all p > 0.10), although change score analysis indicated a relative benefit from the intervention for unmet symptom needs at 8 and 12 weeks post-assessment (effect size = 0.55 and 0.40, respectively). Although a novel approach, the hypothesis that the intervention would benefit perceived unmet needs, psychological morbidity, distress and health-related quality of life was not supported overall. Copyright © 2013 John Wiley & Sons, Ltd.

  2. Randomized trial of two swallowing assessment approaches in patients with acquired brain injury

    DEFF Research Database (Denmark)

    Kjaersgaard, Annette; Nielsen, Lars Hedemann; Sjölund, Bengt H.

    2014-01-01

    OBJECTIVE: To examine whether patients assessed for initiation of oral intake only by Facial-Oral Tract Therapy had a greater risk of developing aspiration pneumonia during neurorehabilitation than patients assessed by Fibreoptic Endoscopic Evaluation of Swallowing. DESIGN: Randomized controlled ...

  3. Variation in the measurement of DNA damage by comet assay measured by the ECVAG dagger inter-laboratory validation trial

    DEFF Research Database (Denmark)

    Forchhammer, Lykke; Johansson, Clara; Loft, Steffen

    2010-01-01

    the level of DNA damage in monocyte-derived THP-1 cells by either visual classification or computer-aided image analysis of pre-made slides, coded cryopreserved samples of cells and reference standard cells (calibration curve samples). The reference standard samples were irradiated with ionizing radiation...... (0-10 Gy) and used to construct a calibration curve to calculate the number of lesions per 10(6) base pair. All laboratories detected dose-response relationships in the coded samples irradiated with ionizing radiation (1.5-7 Gy), but there were overt differences in the level of DNA damage reported...

  4. Inter-Laboratory trial of a standardized sediment contact test with the aquatic plant myriophyllum aquaticum (ISO 16191)

    NARCIS (Netherlands)

    Feiler, U.; Ratte, M.; Arts, G.H.P.; Bazin, C.; Brauer, F.; Casado, C.

    2014-01-01

    A whole-sediment toxicity test with Myriophyllum aquaticum has been developed by the German Federal Institute of Hydrology and standardized within the International Organization for Standardization (ISO; ISO 16191). An international ring-test was performed to evaluate the precision of the test

  5. National Assessment Governing Board and Voluntary National Tests: A Tale of Tribulations without Trials

    Science.gov (United States)

    Guerra, Michael

    2009-01-01

    As the National Assessment Governing Board marks its 20th anniversary, it looks back at its stewardship of the National Assessment of Educational Progress (NAEP) with understandable pride. NAEP existed for 20 years before the Board was established to provide an independent governance structure for the assessment. During its first two decades, NAEP…

  6. Inter-laboratory study of short time exposure (STE) test for predicting eye irritation potential of chemicals and correspondence to globally harmonized system (GHS) classification.

    Science.gov (United States)

    Takahashi, Yutaka; Hayashi, Takumi; Watanabe, Shinichi; Hayashi, Kazuhiko; Koike, Mirei; Aisawa, Noriko; Ebata, Shinya; Sakaguchi, Hitoshi; Nakamura, Tsuneaki; Kuwahara, Hirofumi; Nishiyama, Naohiro

    2009-12-01

    Short time exposure (STE) test using rabbit corneal cell line (SIRC) cells was developed as an alternative eye irritation test. STE test uses relative viability as the endpoint after cells are exposed to the test material at constant concentrations for 5 min. In this inter-laboratory study with 3 laboratories, 44 chemicals with a wide range of classes were evaluated for the transferability, between-lab reproducibility and predictive capacity of the STE test as an alternative eye irritation test. Globally harmonized system (GHS) classification based on Draize eye irritation test data was used as the comparative in vivo data. Transferability was assessed using standard chemicals (sodium lauryl sulfate, calcium thioglycolate, and Tween 80) and the coefficient variations (CVs) of relative viabilities between 3 labs were less than 0.13. The irritation category (Irritant or Non irritant) at each test concentration (5% and 0.05%) in STE test was the same in 3 laboratories for all 44 tested chemicals. The predictive capacity irritation category classification between STE test and GHS were compared, and a good correlation was confirmed (accuracy was 90.9% at all laboratories). In addition, the STE rankings of 1, 2, and 3 classified by the prediction model (PM) based on the relative viability at two concentrations (5% and 0.05%) were highly correlated with the GHS ranks of non-irritant, category 1, and category 2, respectively (accuracy was 75.0% at all laboratories). These results suggest that the STE test possessed easy transferability, reproducibility, good predictive performance.

  7. Results of the Interlaboratory Exercise CNS/CIEMAT-04 Among Environmental Radioactivity Laboratories (Aqueous Solution); Resultados del Ejercicio Interlaboratorios de Radiactividad Ambiental CSN/CIEMAT-04 (Solucion Acuosa)

    Energy Technology Data Exchange (ETDEWEB)

    Romero Gonzalez, M. L.; Barrera Izquierdo, M.

    2004-07-01

    The document describes the outcome of the CSN/CIEMAT-04 interlaboratory test comparison among environmental radioactivity laboratories. The exercise was organised according to the ISO-43 and the ISO/IUPAC/AOAC Harmonised Protocol for the proficiency testing of analytical laboratories. Following the issue of the European Community Drinking Water Directive 98/83/EC concerning the quality of water for human consumption, the last inter-comparison exercise was organised by using a water sample, in an attempt to evaluate the performance of the laboratories analysing the required radioactivity parameters (H-3, gross alpha and beta activity and residual beta). The sample (a synthetic drinking water), was prepared at the National Laboratory for Ionising Radiation's Standards (CIEMAT), and contained the following radionuclides ''241 Am, ''239+240 Pu, ''90Sr, ''137 Cs, ''3 H y ''40 K. The results of the exercise were computed for 38 participating laboratories, and their analytical performance was assessed using the z-score approach. Robust statistics of the participant's results was applied to obtain the median and standard deviation, including suspected outliers. The exercise has revealed and homogeneous behaviour of laboratories, being statistical parameters from the results close to the reference values. A raised percentage os satisfactory laboratory performance has been obtained for gross alpha, gross beta and residual beta: 85, 97 and 87% respectively. The study has shown that participant laboratories perform radioactive determinations in drinking water samples with satisfactory quality levels. (Author) 16 refs.

  8. Systematic review of clinical trials assessing the therapeutic efficacy of visceral leishmaniasis treatments: A first step to assess the feasibility of establishing an individual patient data sharing platform.

    Directory of Open Access Journals (Sweden)

    Jacob T Bush

    2017-09-01

    Full Text Available There are an estimated 200,000 to 400,000 cases of visceral leishmaniasis (VL annually. A variety of factors are taken into account when considering the best therapeutic options to cure a patient and reduce the risk of resistance, including geographical area, malnourishment and HIV coinfection. Pooled analyses combine data from many studies to answer specific scientific questions that cannot be answered with individual studies alone. However, the heterogeneity of study design, data collection, and analysis often makes direct comparison difficult. Individual Participant Data (IPD files can be standardised and analysed, allowing detailed analysis of this merged larger pool, but only a small fraction of systematic reviews and meta-analyses currently employ pooled analysis of IPD. We conducted a systematic literature review to identify published studies and studies reported in clinical trial registries to assess the feasibility of developing a VL data sharing platform to facilitate an IPD-based analysis of clinical trial data. Studies conducted between 1983 to 2015 that reported treatment outcome were eligible.From the 2,271 documents screened, 145 published VL clinical trials were identified, with data from 26,986 patients. Methodologies varied for diagnosis and treatment outcomes, but overall the volume of data potentially available on different drugs and dose regimens identified hundreds or possibly thousands of patients per arm suitable for IPD pooled meta-analyses.A VL data sharing platform would provide an opportunity to maximise scientific use of available data to enable assessment of treatment efficacy, contribute to evidence-based clinical management and guide optimal prospective data collection.

  9. Assessment of the quality of reporting of randomised controlled trials in otorhinolaryngologic literature - adherence to the CONSORT statement.

    Directory of Open Access Journals (Sweden)

    Jeroen P M Peters

    Full Text Available Randomised Controlled Trials (RCTs are the preferred study design when comparing therapeutical interventions in medicine. To improve clarity, consistency and transparency of reporting RCTs, the Consolidated Standards of Reporting Trials (CONSORT statement was developed.(1 To assess the quality of reports and abstracts of RCTs in otorhinolaryngologic literature by using CONSORT checklists, (2 to compare the quality of reports and abstracts of otorhinolaryngologic RCTs between the top 5 general medical journals and top 5 otorhinolaryngologic journals, and (3 to formulate recommendations for authors and editors of otorhinolaryngologic ('ENT' journals.Based on 2012 ISI Web of Knowledge impact factors, the top 5 general medical and ENT journals were selected. On 25 June 2014, using a highly sensitive Cochrane RCT filter and ENT filter, possibly relevant articles since January 1st, 2010 were retrieved and relevant RCTs were selected. We assessed how many CONSORT items were reported adequately in reports and abstracts and compared the two journal types.Otorhinolaryngologic RCTs (n = 15 published in general medical journals reported a mean of 92.1% (95% confidence interval: 89.5%-94.7% of CONSORT items adequately, whereas RCTs (n = 18 published in ENT journals reported a mean of 71.8% (66.7%-76.8% adequately (p < 0.001. For abstracts, means of 70.0% (63.7%-76.3% and 32.3% (26.6-38.0% were found respectively (p < 0.001. Large differences for specific items exist between the two journal types.The quality of reporting of RCTs in otorhinolaryngologic journals is suboptimal. RCTs published in general medical journals have a higher quality of reporting than RCTs published in ENT journals. We recommend authors to report their trial according to the CONSORT Statement and advise editors to endorse the CONSORT Statement and implement the CONSORT Statement in the editorial process to ensure more adequate reporting of RCTs and their abstracts.

  10. Assessment of the Quality of Reporting of Randomised Controlled Trials in Otorhinolaryngologic Literature – Adherence to the CONSORT Statement

    Science.gov (United States)

    Peters, Jeroen P. M.; Hooft, Lotty; Grolman, Wilko; Stegeman, Inge

    2015-01-01

    Background Randomised Controlled Trials (RCTs) are the preferred study design when comparing therapeutical interventions in medicine. To improve clarity, consistency and transparency of reporting RCTs, the Consolidated Standards of Reporting Trials (CONSORT) statement was developed. Objectives (1) To assess the quality of reports and abstracts of RCTs in otorhinolaryngologic literature by using CONSORT checklists, (2) to compare the quality of reports and abstracts of otorhinolaryngologic RCTs between the top 5 general medical journals and top 5 otorhinolaryngologic journals, and (3) to formulate recommendations for authors and editors of otorhinolaryngologic (‘ENT’) journals. Methods Based on 2012 ISI Web of Knowledge impact factors, the top 5 general medical and ENT journals were selected. On 25 June 2014, using a highly sensitive Cochrane RCT filter and ENT filter, possibly relevant articles since January 1st, 2010 were retrieved and relevant RCTs were selected. We assessed how many CONSORT items were reported adequately in reports and abstracts and compared the two journal types. Results Otorhinolaryngologic RCTs (n = 15) published in general medical journals reported a mean of 92.1% (95% confidence interval: 89.5%–94.7%) of CONSORT items adequately, whereas RCTs (n = 18) published in ENT journals reported a mean of 71.8% (66.7%–76.8%) adequately (p CONSORT Statement and advise editors to endorse the CONSORT Statement and implement the CONSORT Statement in the editorial process to ensure more adequate reporting of RCTs and their abstracts. PMID:25793517

  11. Assessment of the quality of reporting of randomised controlled trials in otorhinolaryngologic literature - adherence to the CONSORT statement.

    Science.gov (United States)

    Peters, Jeroen P M; Hooft, Lotty; Grolman, Wilko; Stegeman, Inge

    2015-01-01

    Randomised Controlled Trials (RCTs) are the preferred study design when comparing therapeutical interventions in medicine. To improve clarity, consistency and transparency of reporting RCTs, the Consolidated Standards of Reporting Trials (CONSORT) statement was developed. (1) To assess the quality of reports and abstracts of RCTs in otorhinolaryngologic literature by using CONSORT checklists, (2) to compare the quality of reports and abstracts of otorhinolaryngologic RCTs between the top 5 general medical journals and top 5 otorhinolaryngologic journals, and (3) to formulate recommendations for authors and editors of otorhinolaryngologic ('ENT') journals. Based on 2012 ISI Web of Knowledge impact factors, the top 5 general medical and ENT journals were selected. On 25 June 2014, using a highly sensitive Cochrane RCT filter and ENT filter, possibly relevant articles since January 1st, 2010 were retrieved and relevant RCTs were selected. We assessed how many CONSORT items were reported adequately in reports and abstracts and compared the two journal types. Otorhinolaryngologic RCTs (n = 15) published in general medical journals reported a mean of 92.1% (95% confidence interval: 89.5%-94.7%) of CONSORT items adequately, whereas RCTs (n = 18) published in ENT journals reported a mean of 71.8% (66.7%-76.8%) adequately (p CONSORT Statement and advise editors to endorse the CONSORT Statement and implement the CONSORT Statement in the editorial process to ensure more adequate reporting of RCTs and their abstracts.

  12. Assessing reporting quality of randomized controlled trial abstracts in psychiatry: Adherence to CONSORT for abstracts: A systematic review.

    Science.gov (United States)

    Song, Seung Yeon; Kim, Boyeon; Kim, Inhye; Kim, Sungeun; Kwon, Minjeong; Han, Changsu; Kim, Eunyoung

    2017-01-01

    Reporting quality of randomized controlled trial (RCT) abstracts is important as readers often make their first judgments based on the abstracts. This study aims to assess the reporting quality of psychiatry RCT abstracts published before and after the release of Consolidated Standards of Reporting Trials for Abstracts (CONSORT-A) guidelines. MEDLINE/PubMed search was conducted to identify psychiatric RCTs published during 2005-2007 (pre-CONSORT) and 2012-2014 (post-CONSORT). Two independent reviewers assessed abstracts using a 18-point overall quality score (OQS) based on the CONSORT-A guidelines. Linear regression analysis was conducted to analyze factors associated with reporting quality. Among 1,927 relevant articles, 285 pre-CONSORT and 214 post-CONSORT psychiatric RCT abstracts were included for analysis. The mean OQS improved from 6.9 (range: 3-13; 95% confidence interval (CI): 6.7-7.2) to 8.2 (range: 4-16; 95% CI: 7.8-8.5) after the CONSORT-A guidelines. Despite improvement, methods of randomization, allocation concealment, and funding source remained to be insufficiently reported (CONSORT-A. High-impact general medical journals, multicenter design, positive outcome, and structured abstracts were associated with better reporting quality. The reporting quality in psychiatric RCT abstracts, although improved, remains suboptimal. To improve reporting quality of psychiatry RCT abstracts, greater efforts by both investigators and journal editors are required to enhance better adherence to the CONSORT-A guidelines.

  13. Use of historical control data for assessing treatment effects in clinical trials

    Science.gov (United States)

    Viele, Kert; Berry, Scott; Neuenschwander, Beat; Amzal, Billy; Chen, Fang; Enas, Nathan; Hobbs, Brian; Ibrahim, Joseph G.; Kinnersley, Nelson; Lindborg, Stacy; Micallef, Sandrine; Roychoudhury, Satrajit; Thompson, Laura

    2014-01-01

    Clinical trials rarely, if ever, occur in a vacuum. Generally, large amounts of clinical data are available prior to the start of a study, particularly on the current study’s control arm. There is obvious appeal in using (i.e., ‘borrowing’) this information. With historical data providing information on the control arm, more trial resources can be devoted to the novel treatment while retaining accurate estimates of the current control arm parameters. This can result in more accurate point estimates, increased power, and reduced type I error in clinical trials, provided the historical information is sufficiently similar to the current control data. If this assumption of similarity is not satisfied, however, one can acquire increased mean square error of point estimates due to bias and either reduced power or increased type I error depending on the direction of the bias. In this manuscript, we review several methods for historical borrowing, illustrating how key parameters in each method affect borrowing behavior, and then, we compare these methods on the basis of mean square error, power and type I error. We emphasize two main themes. First, we discuss the idea of ‘dynamic’ (versus ‘static’) borrowing. Second, we emphasize the decision process involved in determining whether or not to include historical borrowing in terms of the perceived likelihood that the current control arm is sufficiently similar to the historical data. Our goal is to provide a clear review of the key issues involved in historical borrowing and provide a comparison of several methods useful for practitioners. PMID:23913901

  14. Rationale for the prevention of syncope trial IV: assessment of midodrine.

    Science.gov (United States)

    Raj, Satish R; Faris, Peter D; McRae, Maureen; Sheldon, Robert S

    2012-12-01

    Vasovagal syncope is a common problem associated with a poor quality of life, which improves when the frequency of syncope is reduced. Effective pharmacological therapies for vasovagal syncope have been elusive. Midodrine is a pro-drug whose primary metabolite is an alpha-1 adrenoreceptor agonist. A few studies have suggested that it may be beneficial in syncope, but all have had significant methodological limitations. A placebo-controlled clinical trial of midodrine for the prevention of vasovagal syncope is needed. The prevention of syncope trial IV (POST 4) is a multicenter, international, randomized, placebo-controlled study of midodrine in the prevention of vasovagal syncope. The primary end point is the time to first recurrence of syncope. Patients will be randomized 1:1 to receive midodrine 10-30 mg/day or matching placebo, and followed for 1 year. Secondary end points include syncope frequency, presyncope, and quality of life. Primary analysis will be performed with an intention-to-treat approach, with a secondary on-treatment analysis. A total sample size of 112, split equally between the two groups, achieves 85 % power to detect a 50 % relative risk reduction when the event rates are 55 and 27.5 % in the placebo and midodrine arms. Allowing for 20 % dropout, we propose to enroll 140 patients. POST 4 is registered with http://www.clinicaltrials.gov (NCT01456481). This study will be the first adequately powered trial to determine whether midodrine is effective in preventing vasovagal syncope. If it is effective, then midodrine may become the first-line pharmacological therapy for this condition.

  15. An immunologic model for rapid vaccine assessment -- a clinical trial in a test tube.

    Science.gov (United States)

    Higbee, Russell G; Byers, Anthony M; Dhir, Vipra; Drake, Donald; Fahlenkamp, Heather G; Gangur, Jyoti; Kachurin, Anatoly; Kachurina, Olga; Leistritz, Del; Ma, Yifan; Mehta, Riyaz; Mishkin, Eric; Moser, Janice; Mosquera, Luis; Nguyen, Mike; Parkhill, Robert; Pawar, Santosh; Poisson, Louis; Sanchez-Schmitz, Guzman; Schanen, Brian; Singh, Inderpal; Song, Haifeng; Tapia, Tenekua; Warren, William; Wittman, Vaughan

    2009-09-01

    While the duration and size of human clinical trials may be difficult to reduce, there are several parameters in pre-clinical vaccine development that may be possible to further optimise. By increasing the accuracy of the models used for pre-clinical vaccine testing, it should be possible to increase the probability that any particular vaccine candidate will be successful in human trials. In addition, an improved model will allow the collection of increasingly more-informative data in pre-clinical tests, thus aiding the rational design and formulation of candidates entered into clinical evaluation. An acceleration and increase in sophistication of pre-clinical vaccine development will thus require the advent of more physiologically-accurate models of the human immune system, coupled with substantial advances in the mechanistic understanding of vaccine efficacy, achieved by using this model. We believe the best viable option available is to use human cells and/or tissues in a functional in vitro model of human physiology. Not only will this more accurately model human diseases, it will also eliminate any ethical, moral and scientific issues involved with use of live humans and animals. An in vitro model, termed "MIMIC" (Modular IMmune In vitro Construct), was designed and developed to reflect the human immune system in a well-based format. The MIMIC System is a laboratory-based methodology that replicates the human immune system response. It is highly automated, and can be used to simulate a clinical trial for a diverse population, without putting human subjects at risk. The MIMIC System uses the circulating immune cells of individual donors to recapitulate each individual human immune response by maintaining the autonomy of the donor. Thus, an in vitro test system has been created that is functionally equivalent to the donor's own immune system and is designed to respond in a similar manner to the in vivo response. 2009 FRAME.

  16. The use of GLIM and the bootstrap in assessing a clinical trial of two drugs.

    Science.gov (United States)

    Mapleson, W W

    1986-01-01

    An approach is described for estimating the dose of a new drug which is equipotent to an established dose of an old drug. The approach is basically that of the parallel-line assay but it can allow for concomitant variables and, by exploiting the facilities available in the statistical computer package GLIM (generalized linear interactive modelling), the approach can be applied when the residuals conform to one of a number of distributions and, with suitable safeguards, to continuous, discrete and even 'scored' responses. In some circumstances, it is necessary to obtain confidence limits by Efron's 'bootstrap' technique. The method is illustrated with results from a trial of two premedicant drugs in children.

  17. Identification and description of controlled clinical trials published in Spanish Gynaecology and Obstetrics journals and risk of bias assessment of trials on assisted reproductive techniques.

    Science.gov (United States)

    Gutarra-Vilchez, Rosa B; Pardo-Hernandez, Hector; Arévalo-Rodríguez, Ingrid; Buitrago, Diana; Bonfill, Xavier

    2016-08-01

    To identify and describe controlled clinical trials (CCTs) published in Spanish Gynaecology and Obstetrics journals. In addition, to assess the quality of the CCTs on Assisted Reproduction Techniques (ART) identified in this project. In order to identify eligible CCTs, all Spanish Gynaecology and Obstetrics journals were handsearched. Handsearching was conducted following the guidelines provided by the Cochrane Collaboration, which state that each journal article must be carefully reviewed, including original articles and other types of studies, letters to the editor, abstracts, and conference presentations. The results of the handsearching process were compared with an electronic search conducted in MEDLINE (PubMed). A descriptive analysis of the main characteristics of the identified CCTs was performed, as well as a methodological assessment of CCTs on ART. Sixteen Gynaecology and Obstetrics journals were identified, four of which have been indexed in MEDLINE at some point, although not currently. The journal with the most CCTs was "Progresos de Obstetricia y Ginecología". A total of 235 CCTs were published in these journals, of which 29 were on ART. Most CCTs (216, 91.9%) were carried out in a hospital setting; 201 (89.4%) were unicentric. Obstetrics was the most studied subspecialty (46.4%). Among CCTs on ART, the risk of bias was predominantly high. The number of CCTs published in Spanish Gynaecology and Obstetrics journals is limited. CCTs on ART present deficiencies in the report of results and low methodological quality. It is advised that authors and journals adhere to the CONSORT statement and to the Cochrane Collaboration recommendations to reduce risk of bias when designing and disseminating research projects. Copyright © 2016 Elsevier Ireland Ltd. All rights reserved.

  18. Interlaboratory comparison of mineral constituents in a sample from the Herrin (No. 6) coal bed from Illinois

    Science.gov (United States)

    Finkelman, Robert B.; Fiene, F.L.; Miller, R.N.; Simon, F.O.

    1984-01-01

    Approximately 20 kg of the Herrin (No. 6) coal was collected from a strip mine in St. Clair County, Ill. A 10-kg portion was ground to -60 mesh, homogenized, and riffled into 128 splits of 70-80 g each. Homogeneity of these splits was confirmed by moisture, ash, and sulfur analyses of six randomly selected splits. Results of these analyses were within the ASTM (American Society for Testing and Materials) guidelines for interlaboratory precision. Splits of the Herrin (No. 6) coal were then transmitted to more than 30 laboratories for analysis. Low-temperature plasma oxidation was used to isolate inorganic matter for quantitative chemical and mineralogical analysis. Despite a wide variation in ashing conditions, only minor variations in ash yields were obtained; these variations were attributed to differences in operating temperature and moisture content. Mineralogical analyses of low-temperature ash (LTA) concentrates prepared by five different laboratories indicated variations within the limits of analytical error. The mean values, in weight percent, for the major minerals are as follows: calcite, 9; quartz, 20; pyrite, 23; kaolinite, 14; and illite+mixed-layer clays, 31. Normative mineralogical calculations and Fourier transform infrared analysis (FTIR) yielded results similar to those obtained from X-ray diffraction (XRD). Choosing appropriate mineral standards was found to be critical for the proper use of analytical techniques such as XRD and FTIR. Good interlaboratory agreement was obtained for most major, minor, and trace elements despite differences in analytical procedures and in the type of sample analyzed (coal, high-temperature ash, or LTA). Discrepancies between analyses for zinc, strontium, manganese, and iron may be attributed to sampling inhomogeneity problems. Mossbauer spectroscopy showed that approximately 44 percent of the pyritic sulfur was lost through weathering in the first year after preparation of the interlaboratory sample. Szomolnokite

  19. The effect of cardiorespiratory fitness assessment in preventive health checks: a randomised controlled trial

    DEFF Research Database (Denmark)

    Høj, Kirsten; Skriver, Mette Vinther; Maindal, Helle Terkildsen

    2018-01-01

    Background: Poor cardiorespiratory fitness (CRF) increases morbidity and mortality risks. Routine CRF assessment in clinical practice has thus been advocated, but little is known about the effect. In this study, we investigated the effect of CRF assessment on CRF in a preventive health check...... programme. Methods: We used a randomised design, in which we invited 4153 middle-aged adults and included 2201 participants who received a preventive health check with CRF assessment (intervention) or without CRF assessment (control). After 1 year, participants were examined. The primary outcomes were....... Conclusion: Preventive health checks with CRF assessment did not provide higher CRF levels at 1-year follow-up than preventive health checks without CRF assessment....

  20. Cross-sectional study of Pfizer-sponsored clinical trials: assessment of time to publication and publication history.

    Science.gov (United States)

    Mooney, LaVerne A; Fay, Lorna

    2016-07-18

    To estimate the proportion of Pfizer-sponsored clinical trials that completed in 2010 and are published as manuscripts in the peer-reviewed literature, and to assess the manuscript development history. Retrospective, cross-sectional analysis. Clinical trials registered in ClinicalTrials.gov that completed in 2010 for approved, Pfizer prescription products in patients or vaccines in healthy participants. The proportion of studies for which the primary outcome(s) was published and the median time from study completion to publication. The manuscript development history included the number of times a manuscript was submitted before it was accepted for publication. Among registered clinical trials for which Pfizer was the sponsor that completed in 2010, 76 met all inclusion criteria. The primary outcome(s) for 65 (85%) studies was published in 71 manuscripts; the median time to publication was 31 months (range 3-63 months). Of the remaining 11 studies, 2 had been submitted to at least one journal, 2 had not yet been submitted and 7 had no plans to publish because the study had terminated early due to recruitment challenges. Manuscripts accepted at the first choice journal were published at median time of 28 months (range 8-63, n=31), those accepted at second choice journal were published at 32 months (3-45, n=19), and for those accepted at third choice journal, it was 40 months (range 24-53, n=13). The publication rate and median time to publication from study completion for Pfizer-sponsored studies were comparable to those previously reported for combined analyses of industry and non-industry sectors. Opportunities exist for sponsors, authors and journals to explore ideas that would facilitate more timely publication for clinical trial results. However, to be effective, such changes may need to revisit the entire publication process. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to

  1. An open trial assessment of "The Number Race", an adaptive computer game for remediation of dyscalculia

    Directory of Open Access Journals (Sweden)

    Cohen Laurent

    2006-05-01

    Full Text Available Abstract Background In a companion article 1, we described the development and evaluation of software designed to remediate dyscalculia. This software is based on the hypothesis that dyscalculia is due to a "core deficit" in number sense or in its access via symbolic information. Here we review the evidence for this hypothesis, and present results from an initial open-trial test of the software in a sample of nine 7–9 year old children with mathematical difficulties. Methods Children completed adaptive training on numerical comparison for half an hour a day, four days a week over a period of five-weeks. They were tested before and after intervention on their performance in core numerical tasks: counting, transcoding, base-10 comprehension, enumeration, addition, subtraction, and symbolic and non-symbolic numerical comparison. Results Children showed specific increases in performance on core number sense tasks. Speed of subitizing and numerical comparison increased by several hundred msec. Subtraction accuracy increased by an average of 23%. Performance on addition and base-10 comprehension tasks did not improve over the period of the study. Conclusion Initial open-trial testing showed promising results, and suggested that the software was successful in increasing number sense over the short period of the study. However these results need to be followed up with larger, controlled studies. The issues of transfer to higher-level tasks, and of the best developmental time window for intervention also need to be addressed.

  2. An open trial assessment of "The Number Race", an adaptive computer game for remediation of dyscalculia.

    Science.gov (United States)

    Wilson, Anna J; Revkin, Susannah K; Cohen, David; Cohen, Laurent; Dehaene, Stanislas

    2006-05-30

    In a companion article, we described the development and evaluation of software designed to remediate dyscalculia. This software is based on the hypothesis that dyscalculia is due to a "core deficit" in number sense or in its access via symbolic information. Here we review the evidence for this hypothesis, and present results from an initial open-trial test of the software in a sample of nine 7-9 year old children with mathematical difficulties. Children completed adaptive training on numerical comparison for half an hour a day, four days a week over a period of five-weeks. They were tested before and after intervention on their performance in core numerical tasks: counting, transcoding, base-10 comprehension, enumeration, addition, subtraction, and symbolic and non-symbolic numerical comparison. Children showed specific increases in performance on core number sense tasks. Speed of subitizing and numerical comparison increased by several hundred msec. Subtraction accuracy increased by an average of 23%. Performance on addition and base-10 comprehension tasks did not improve over the period of the study. Initial open-trial testing showed promising results, and suggested that the software was successful in increasing number sense over the short period of the study. However these results need to be followed up with larger, controlled studies. The issues of transfer to higher-level tasks, and of the best developmental time window for intervention also need to be addressed.

  3. Assessment and model guided cancer screening promotion by village doctors in China: a randomized controlled trial protocol.

    Science.gov (United States)

    Feng, Rui; Shen, Xingrong; Chai, Jing; Chen, Penglai; Cheng, Jing; Liang, Han; Zhao, Ting; Sha, Rui; Li, Kaichun; Wang, Debin

    2015-10-12

    Proven cost-effectiveness contrasted by low uptake of cancer screening (CS) calls for new methodologies promoting the service. Contemporary interventions in this regard relies primarily on strategies targeting general or specific groups with limited attention being paid to individualized approaches. This trial tests a novel package promoting CS utilization via continuous and tailored counseling delivered by primary caregivers. It aims at demonstrating that high risk individuals in the intervention arm will, compared to those in the delayed intervention condition, show increased use of CS service. The trial adopts a quasi-randomized controlled trial design and involves 2160 high risk individuals selected, via rapid and detailed risk assessments, from about 72,000 farmers aged 35+ in 36 administrative villages randomized into equal intervention and delayed intervention arms. The CS intervention package uses: a) village doctors and village clinics to deliver personalized and thus relatively sophisticated CS counseling; b) two-stage risk assessment models in identifying high risk individuals to focus the intervention on the most needed; c) standardized operation procedures to guide conduct of counseling; d) real-time effectiveness and quality monitoring to leverage continuous improvement; e) web-based electronic system to enable prioritizing complex determinants of CS uptake and tailoring counseling sessions to the changing needs of individual farmers. The intervention arm receives baseline and semiannual follow up evaluations plus CS counseling for 5 years; while the delayed intervention arm, only the same baseline and follow-up evaluations for the first 5 years and CS counseling starting from the 6th year if the intervention proved effective. Evaluation measures include: CS uptake by high risk farmers and changes in their knowledge, perceptions and self-efficacy about CS. Given the complexity and heterogeneity in the determinant system of individual CS service

  4. From kidnapping to corruption: some trials and tribulations in the implementation of rapid assessment studies.

    Science.gov (United States)

    Fazey

    2000-03-01

    In between the description of the methodology and the discussion of assessment results, lies a crucial area, namely that of implementation. If assessment methods cannot be implemented, there will be no assessment report, and no recommendations for intervention or policy development. Implementation is a critical, yet neglected, area of drug policy delivery. This paper describes some of the problems associated with the implementation of rapid assessment studies commissioned by the United Nations International Drug Control Programme (UNDCP) over the last 5 years. Drawing on the author's experience of commissioning rapid assessments on the extent and nature of drug use in a variety of international settings and political contexts, the paper draws eight main lessons for rapid assessments commissioned within the context of international development programmes. These are: (1) the need to get high level political support; (2) the need to employ competent social scientists to run the assessment; (3) the need to define exactly the object of the assessment; (4) the necessity of spelling out the methodology and the time scale; (5) the careful establishment of the financial framework; (6) the importance of cultivating contacts; (7) the necessity of actually getting a report; and (8) the danger of accepting an unseen or unread consultant's report as the basis for programme implementation. The paper emphasises the critical importance of planning prior to implementation and flexibility during it.

  5. New scoring methodology improves the sensitivity of the Alzheimer's Disease Assessment Scale-Cognitive subscale (ADAS-Cog) in clinical trials.

    Science.gov (United States)

    Verma, Nishant; Beretvas, S Natasha; Pascual, Belen; Masdeu, Joseph C; Markey, Mia K

    2015-11-12

    As currently used, the Alzheimer's Disease Assessment Scale-Cognitive subscale (ADAS-Cog) has low sensitivity for measuring Alzheimer's disease progression in clinical trials. A major reason behind the low sensitivity is its sub-optimal scoring methodology, which can be improved to obtain better sensitivity. Using item response theory, we developed a new scoring methodology (ADAS-CogIRT) for the ADAS-Cog, which addresses several major limitations of the current scoring methodology. The sensitivity of the ADAS-CogIRT methodology was evaluated using clinical trial simulations as well as a negative clinical trial, which had shown an evidence of a treatment effect. The ADAS-Cog was found to measure impairment in three cognitive domains of memory, language, and praxis. The ADAS-CogIRT methodology required significantly fewer patients and shorter trial durations as compared to the current scoring methodology when both were evaluated in simulated clinical trials. When validated on data from a real clinical trial, the ADAS-CogIRT methodology had higher sensitivity than the current scoring methodology in detecting the treatment effect. The proposed scoring methodology significantly improves the sensitivity of the ADAS-Cog in measuring progression of cognitive impairment in clinical trials focused in the mild-to-moderate Alzheimer's disease stage. This provides a boost to the efficiency of clinical trials requiring fewer patients and shorter durations for investigating disease-modifying treatments.

  6. Using the STROBE Statement to Assess Reporting of Observational Trials in Hand Surgery

    Science.gov (United States)

    Sorensen, Amelia A.; Wojahn, Robert D.; Manske, Mary Claire; Calfee, Ryan P.

    2014-01-01

    Purpose To use the Strengthening the Reporting of Observational Studies in Epidemiology (STROBE) statement checklist to critically evaluate the change in quality of observational trial reporting in the Journal of Hand Surgery American between 2005 and 2011. Methods A cross-sectional analysis of observational studies published in Journal of Hand Surgery American was designed to sample 2 6-month periods of publication (March 2005 - August 2005 and June 2011 - November 2011). Fifty-one items were extracted from the STROBE statement for evaluation. Overall STROBE compliance rates for articles and specific checklist items were determined. Final compliance percentages from each period were compared by Student t-testing. Changes in item compliance over time were quantified. Results Overall compliance with the STROBE statement was 38% (range, 10-54%) in 2005 and 58% (range, 39%-85%) for 2011 manuscripts representing a significant improvement. Seventy-five percent or greater of articles (2005/2011) provided the explicit reporting of background (100%/97%), follow-up time (85%/94%), overall interpretation of data (100%/94%), and results of similar studies (95%/89%). Twenty-five percent or less of articles provided the study design in the abstract (10%/20%), a clear description of the study's setting (10%/23%), the handling of missing data (0%/6%), the potential directions of bias (5%/11%) and use of a power analysis (0%/17%). Eighty-six percent (44/51) of items were more frequently satisfied in 2011 articles compared to 2005 publications. Absolute increases in compliance rates of ≥40% were noted in 10 items (20%) with no worsening in compliance for an individual item over 6%. Discussion The overall quality of the reporting of observational trials in Journal of Hand Surgery American improved from 2005 to 2011. Current observational trials in hand surgery could still benefit from increased reporting of methodologic details including the use of power analyses, the handling of

  7. Observer reliability of CT angiography in the assessment of acute ischaemic stroke: data from the Third International Stroke Trial

    Energy Technology Data Exchange (ETDEWEB)

    Mair, Grant; Farrall, Andrew J.; Sellar, Robin J.; Mollison, Daisy; Sakka, Eleni; Palmer, Jeb; Wardlaw, Joanna M. [University of Edinburgh, Western General Hospital, Division of Neuroimaging Sciences, Edinburgh (United Kingdom); Kummer, Ruediger von [Dresden University Stroke Centre, University Hospital, Department of Neuroradiology, Dresden (Germany); Adami, Alessandro [Sacro Cuore-Don Calabria Hospital, Stroke Center, Department of Neurology, Negrar (Italy); White, Philip M. [Stroke Research Group, Newcastle upon Tyne (United Kingdom); Adams, Matthew E. [National Hospital for Neurology and Neurosurgery, Department of Neuroradiology, London (United Kingdom); Yan, Bernard [Royal Melbourne Hospital, Neurovascular Research Group, Parkville (Australia); Demchuk, Andrew M. [Calgary Stroke Program, Department of Clinical Neurosciences, Calgary (Canada); Ramaswamy, Rajesh; Rodrigues, Mark A.; Samji, Karim; Baird, Andrew J. [Royal Infirmary of Edinburgh, Department of Radiology, Edinburgh (United Kingdom); Boyd, Elena V. [Northwick Park Hospital, Department of Radiology, Harrow (United Kingdom); Cohen, Geoff; Perry, David; Sandercock, Peter A.G. [University of Edinburgh, Western General Hospital, Division of Clinical Neurosciences, Edinburgh (United Kingdom); Lindley, Richard [University of Sydney, Westmead Hospital Clinical School and The George Institute for Global Health, Sydney (Australia); Collaboration: The IST-3 Collaborative Group

    2014-10-07

    CT angiography (CTA) is often used for assessing patients with acute ischaemic stroke. Only limited observer reliability data exist. We tested inter- and intra-observer reliability for the assessment of CTA in acute ischaemic stroke. We selected 15 cases from the Third International Stroke Trial (IST-3, ISRCTN25765518) with various degrees of arterial obstruction in different intracranial locations on CTA. To assess inter-observer reliability, seven members of the IST-3 expert image reading panel (>5 years experience reading CTA) and seven radiology trainees (<2 years experience) rated all 15 scans independently and blind to clinical data for: presence (versus absence) of any intracranial arterial abnormality (stenosis or occlusion), severity of arterial abnormality using relevant scales (IST-3 angiography score, Thrombolysis in Cerebral Infarction (TICI) score, Clot Burden Score), collateral supply and visibility of a perfusion defect on CTA source images (CTA-SI). Intra-observer reliability was assessed using independently repeated expert panel scan ratings. We assessed observer agreement with Krippendorff's-alpha (K-alpha). Among experienced observers, inter-observer agreement was substantial for the identification of any angiographic abnormality (K-alpha = 0.70) and with an angiography assessment scale (K-alpha = 0.60-0.66). There was less agreement for grades of collateral supply (K-alpha = 0.56) or for identification of a perfusion defect on CTA-SI (K-alpha = 0.32). Radiology trainees performed as well as expert readers when additional training was undertaken (neuroradiology specialist trainees). Intra-observer agreement among experts provided similar results (K-alpha = 0.33-0.72). For most imaging characteristics assessed, CTA has moderate to substantial observer agreement in acute ischaemic stroke. Experienced readers and those with specialist training perform best. (orig.)

  8. Observer reliability of CT angiography in the assessment of acute ischaemic stroke: data from the Third International Stroke Trial

    International Nuclear Information System (INIS)

    Mair, Grant; Farrall, Andrew J.; Sellar, Robin J.; Mollison, Daisy; Sakka, Eleni; Palmer, Jeb; Wardlaw, Joanna M.; Kummer, Ruediger von; Adami, Alessandro; White, Philip M.; Adams, Matthew E.; Yan, Bernard; Demchuk, Andrew M.; Ramaswamy, Rajesh; Rodrigues, Mark A.; Samji, Karim; Baird, Andrew J.; Boyd, Elena V.; Cohen, Geoff; Perry, David; Sandercock, Peter A.G.; Lindley, Richard

    2015-01-01

    CT angiography (CTA) is often used for assessing patients with acute ischaemic stroke. Only limited observer reliability data exist. We tested inter- and intra-observer reliability for the assessment of CTA in acute ischaemic stroke. We selected 15 cases from the Third International Stroke Trial (IST-3, ISRCTN25765518) with various degrees of arterial obstruction in different intracranial locations on CTA. To assess inter-observer reliability, seven members of the IST-3 expert image reading panel (>5 years experience reading CTA) and seven radiology trainees (<2 years experience) rated all 15 scans independently and blind to clinical data for: presence (versus absence) of any intracranial arterial abnormality (stenosis or occlusion), severity of arterial abnormality using relevant scales (IST-3 angiography score, Thrombolysis in Cerebral Infarction (TICI) score, Clot Burden Score), collateral supply and visibility of a perfusion defect on CTA source images (CTA-SI). Intra-observer reliability was assessed using independently repeated expert panel scan ratings. We assessed observer agreement with Krippendorff's-alpha (K-alpha). Among experienced observers, inter-observer agreement was substantial for the identification of any angiographic abnormality (K-alpha = 0.70) and with an angiography assessment scale (K-alpha = 0.60-0.66). There was less agreement for grades of collateral supply (K-alpha = 0.56) or for identification of a perfusion defect on CTA-SI (K-alpha = 0.32). Radiology trainees performed as well as expert readers when additional training was undertaken (neuroradiology specialist trainees). Intra-observer agreement among experts provided similar results (K-alpha = 0.33-0.72). For most imaging characteristics assessed, CTA has moderate to substantial observer agreement in acute ischaemic stroke. Experienced readers and those with specialist training perform best. (orig.)

  9. Using community readiness key informant assessments in a randomized group prevention trial: impact of a participatory community-media intervention.

    Science.gov (United States)

    Slater, Michael D; Edwards, Ruth W; Plested, Barbara A; Thurman, Pamela J; Kelly, Kathleen J; Comello, Maria Leonora G; Keefe, Thomas J

    2005-02-01

    This study examines the role of key informant community readiness assessments in a randomized group trial testing the impact of a participatory community-media intervention (which was also complemented by in-school efforts). These assessments were used to help match communities in random assignment, as a source of formative data about the community, as the basis for a coalition-building workshop, and as an evaluation tool, with a follow-up set of surveys approximately 2 years after the baseline survey. Results of the nested, random effects analysis indicated that the intervention influenced community knowledge of efforts and (at marginally significant levels) improved prevention leadership quality and community climate supportive of prevention efforts. There was evidence that the professional affiliation of informants in some cases had an effect on their assessments, which could be controlled in the analysis. The authors conclude that key informant community readiness assessments can usefully serve to supplement aggregated measures of individual attitudes and behavior (reported elsewhere for this study) in evaluating community-based interventions.

  10. Optimizing Outcome Assessment in Multicenter TBI Trials: Perspectives From TRACK-TBI and the TBI Endpoints Development Initiative.

    Science.gov (United States)

    Bodien, Yelena G; McCrea, Michael; Dikmen, Sureyya; Temkin, Nancy; Boase, Kim; Machamer, Joan; Taylor, Sabrina R; Sherer, Mark; Levin, Harvey; Kramer, Joel H; Corrigan, John D; McAllister, Thomas W; Whyte, John; Manley, Geoffrey T; Giacino, Joseph T

    2018-01-30

    Traumatic brain injury (TBI) is a global public health problem that affects the long-term cognitive, physical, and psychological health of patients, while also having a major impact on family and caregivers. In stark contrast to the effective trials that have been conducted in other neurological diseases, nearly 30 studies of interventions employed during acute hospital care for TBI have failed to identify treatments that improve outcome. Many factors may confound the ability to detect true and meaningful treatment effects. One promising area for improving the precision of intervention studies is to optimize the validity of the outcome assessment battery by using well-designed tools and data collection strategies to reduce variability in the outcome data. The Transforming Research and Clinical Knowledge in TBI (TRACK-TBI) study, conducted at 18 sites across the United States, implemented a multidimensional outcome assessment battery with 22 measures aimed at characterizing TBI outcome up to 1 year postinjury. In parallel, through the TBI Endpoints Development (TED) Initiative, federal agencies and investigators have partnered to identify the most valid, reliable, and sensitive outcome assessments for TBI. Here, we present lessons learned from the TRACK-TBI and TED initiatives aimed at optimizing the validity of outcome assessment in TBI.

  11. An Assessment of the Risk of Bias in Randomized Controlled Trial Reports Published in Prosthodontic and Implant Dentistry Journals.

    Science.gov (United States)

    Papageorgiou, Spyridon N; Kloukos, Dimitrios; Petridis, Haralampos; Pandis, Nikolaos

    2015-01-01

    The objective of this study was to assess the risk of bias of randomized controlled trials (RCTs) published in prosthodontic and implant dentistry journals. The last 30 issues of 9 journals in the field of prosthodontic and implant dentistry (Clinical Implant Dentistry and Related Research, Clinical Oral Implants Research, Implant Dentistry, International Journal of Oral & Maxillofacial Implants, International Journal of Periodontics and Restorative Dentistry, International Journal of Prosthodontics, Journal of Dentistry, Journal of Oral Rehabilitation, and Journal of Prosthetic Dentistry) were hand-searched for RCTs. Risk of bias was assessed using the Cochrane Collaboration's risk of bias tool and analyzed descriptively. From the 3,667 articles screened, a total of 147 RCTs were identified and included. The number of published RCTs increased with time. The overall distribution of a high risk of bias assessment varied across the domains of the Cochrane risk of bias tool: 8% for random sequence generation, 18% for allocation concealment, 41% for masking, 47% for blinding of outcome assessment, 7% for incomplete outcome data, 12% for selective reporting, and 41% for other biases. The distribution of high risk of bias for RCTs published in the selected prosthodontic and implant dentistry journals varied among journals and ranged from 8% to 47%, which can be considered as substantial.

  12. [Can we assess the efficacy of psychotherapies in a clinical trial?

    Science.gov (United States)

    Correard, N; Consoloni, J-L; Belzeaux, R; Fakra, E; Adida, M; Azorin, J-M

    2016-12-01

    Extensive evidence demonstrates that psychotherapy can be an efficacious and effective health care service for a wide range of mental health and health conditions. Recently, an important distinction between efficacy research and effectiveness research has been made within research focused on the outcome of psychotherapy. Data from both efficacy and effectiveness studies are fundamental to a complete understanding of the potential impact of a psychotherapy and the way to carry successful psychotherapeutics interventions to routine clinical practice. Efficacy studies, using randomized controlled trials, maximize the internal validity of a study by the use of design features, such as random assignment to a psychotherapeutic intervention and control conditions, training of therapists to a specified level of competence in providing the treatment, and ensuring that all participants have the condition that the treatment was designed to address. The randomized controlled trials allowed to objectify the efficacy of the psychotherapies in multiple pathological contexts, as we will see with the example of bipolar disorders. On the other hand, effectiveness studies strive to maximize external validity (while maintaining an adequate level of internal validity) by locating the study within clinical service sites that provide ongoing health services, using clinicians who are routinely providing psychological services and patients who have been referred to the clinical settings. These studies do not allow understanding changes and psychotherapeutic processes in real practice. A solution might be found in using pragmatic case studies in a systematic manner to constitute ecologically valid samples and measure change and psychotherapeutic processes during clinically significant periods of time. © L’Encéphale, Paris, 2016.

  13. Randomized trial to assess the effect of supervised and unsupervised video feedback on teaching practical skills.

    Science.gov (United States)

    Nesbitt, Craig I; Phillips, Alexander W; Searle, Roger F; Stansby, Gerard

    2015-01-01

    Feedback is a vital component of the learning process; however, great variation exists in the quality, quantity, and method of delivery. Video feedback is not commonly used in the teaching of surgical skills. The aim of this trial was to evaluate the benefit of 2 types of video feedback-individualized video feedback (IVF), with the student reviewing their performance with an expert tutor, and unsupervised video-enhanced feedback (UVF), where the student reviews their own performance together with an expert teaching video-to determine if these improve performance when compared with a standard lecture feedback. A prospective blinded randomized control trial comparing lecture feedback with IVF and UVF was carried out. Students were scored by 2 experts directly observing the performance and 2 blinded experts using a validated pro forma. Participants were recorded on video when performing a suturing task. They then received their feedback via any of the 3 methods before being invited to repeat the task. A total of 32 students were recruited between the 3 groups. There was no significant difference in suturing skill performance scores given by those directly observing the students and those blinded to the participant. There was no statistically significant difference between the 2 video feedback groups (p = 1.000), but there was significant improvement between standard lecture feedback and UVF (p = 0.047) and IVF (p = 0.001). Video feedback can facilitate greater learning of clinical skills. Students can attain a similar level of surgical skills improvement with UVF as with teacher-intensive IVF. Copyright © 2015 Association of Program Directors in Surgery. Published by Elsevier Inc. All rights reserved.

  14. Status Report of the Inter-Laboratory Task Force on Remote Operation

    International Nuclear Information System (INIS)

    Phinney, Nan

    2001-01-01

    The next generation of particle accelerators will be major projects which may require a new mode of international and inter-laboratory collaboration. They are likely to be too costly to be funded by a single nation and too large to be built by a single laboratory. The tremendous technical challenge of a new facility requires a critical mass of highly qualified and experienced physicists and engineers. These experts are presently distributed among the major accelerator centers around the world and it is believed important to maintain and develop this broad base of expertise. The successful accelerator technology development of recent decades depended on extensive exchange of people with complementary technical skills. Therefore, it is desirable and probably necessary that several accelerator laboratories will participate in any future project. A consequence of a multi-laboratory project is that the accelerator will be located a considerable distance from most of the contributing institutions which design, build and operate it. These considerations led the International Committee for Future Accelerators to initiate a study on the general and technical implications of such a collaboration. Two task forces were formed in February 2000 to conduct this study and they were asked to prepare a report on a time scale of one year. The task force on Remote Operation included members from most of the major accelerator laboratories around the world with expertise on accelerator operation, controls software, communication technologies, hardware design and maintenance. The task force members gathered information from the experts at their own institutions and from available experience in other fields, particularly astronomy. The task force on Remote Operations began by developing a model for an international multi-laboratory collaboration to construct and operate an accelerator facility. This model is described in section 3. While it is clear that there are numerous alternative

  15. An Inter-Laboratory Comparison for the Urinary Acrolein Biomarker 3-Hydroxypropyl-Mercapturic Acid (3-HPMA

    Directory of Open Access Journals (Sweden)

    Scherer Gerhard

    2017-01-01

    Full Text Available An inter-laboratory comparison study on the acrolein biomarker of exposure 3-hydroxypropyl-mercapturic acid (3-HPMA with 12 laboratories from 7 globally distributed countries was performed. The laboratories received coded triplicates of 4 spiked and lyophilized urine samples (LU, 12 samples as well as 5 authentic urine pool samples (PU, 15 samples covering the 3-HPMA concentration range from background (non-smoking to heavy smoking levels for analysis by using their own (in-house analytical method. All laboratories applied liquid chromatography with tandem mass spectrometry (LC-MS/MS, with most of them (10 of 12 using solid phase extraction (SPE as sample work-up procedure. The intra-laboratory variation (indicating repeatability was determined by calculating the standard deviation (sr and the coefficient of variation (CVr of the triplicates, whereas the inter-laboratory variation (indicating reproducibility was determined by calculating the standard deviation between laboratories (sR and the corresponding coefficient of variation (CVR. After removal of outlier samples or laboratories, the mean CVr values for LU and PU test samples ranged from 2.1–3.6% (mean: 2.8% and 2.4–3.7% (mean: 3.3%, respectively, indicating good repeatability for the determination of 3-HPMA in both sample types. CVR for LU and PU test samples ranged from 9.1–31.9% (mean: 18.8% and 13.9–27.0% (mean: 18.5%, respectively, indicating limited reproducibility in 3-HPMA analysis for both sample types. Re-calculation of the PU results by applying an embedded calibration (EC, derived from the reported peak areas for the LU test samples, somewhat improved the CVR values (range: 9.6–28.8%, mean: 16.7%.

  16. Assessing adherence in the CAPRISA 004 tenofovir gel HIV prevention trial: results of a nested case-control study.

    Science.gov (United States)

    MacQueen, Kathleen M; Weaver, Mark A; van Loggerenberg, Francois; Succop, Stacey; Majola, Nelisle; Taylor, Doug; Karim, Quarraisha Abdool; Karim, Salim Abdool

    2014-05-01

    Adherence undeniably impacts product effectiveness in microbicide trials, but the connection has proven challenging to quantify using routinely collected behavioral data. We explored this relationship using a nested case-control study in the CAPRISA 004 Tenofovir (TFV) gel HIV prevention trial. Detailed 3-month recall data on sex events, condom and gel use were collected from 72 incident cases and 205 uninfected controls. We then assessed how the relationship between self-reported adherence and HIV acquisition differed between the TFV and placebo gel groups, an interaction effect that should exist if effectiveness increases with adherence. The CAPRISA 004 trial determined that randomization to TFV gel was associated with a significant reduction in risk of HIV acquisition. In our nested case-control study, however, we did not observe a meaningful decrease in the relative odds of infection-TFV versus placebo-as self-reported adherence increased. To the contrary, exploratory sub-group analysis of the case-control data identified greater evidence for a protective effect of TFV gel among participants reporting less than 80 % adherence to the protocol-defined regimen (odds ratio (OR) 0.30; 95 % CI 0.11-0.78) than among those reporting ≥ 80 % adherence (Odds Ratio 0.81; 95 % CI 0.34-1.92). The small number of cases may have inhibited our ability to detect the hypothesized interaction between adherence and effectiveness. Nonetheless, our results re-emphasize the challenges faced by investigators when adherence may be miss-measured, miss-reported, or confounded with the risk of HIV.

  17. Background rates of adverse pregnancy outcomes for assessing the safety of maternal vaccine trials in sub-Saharan Africa.

    Directory of Open Access Journals (Sweden)

    Lauren A V Orenstein

    Full Text Available Maternal immunization has gained traction as a strategy to diminish maternal and young infant mortality attributable to infectious diseases. Background rates of adverse pregnancy outcomes are crucial to interpret results of clinical trials in Sub-Saharan Africa.We developed a mathematical model that calculates a clinical trial's expected number of neonatal and maternal deaths at an interim safety assessment based on the person-time observed during different risk windows. This model was compared to crude multiplication of the maternal mortality ratio and neonatal mortality rate by the number of live births. Systematic reviews of severe acute maternal morbidity (SAMM, low birth weight (LBW, prematurity, and major congenital malformations (MCM in Sub-Saharan African countries were also performed.Accounting for the person-time observed during different risk periods yields lower, more conservative estimates of expected maternal and neonatal deaths, particularly at an interim safety evaluation soon after a large number of deliveries. Median incidence of SAMM in 16 reports was 40.7 (IQR: 10.6-73.3 per 1,000 total births, and the most common causes were hemorrhage (34%, dystocia (22%, and severe hypertensive disorders of pregnancy (22%. Proportions of liveborn infants who were LBW (median 13.3%, IQR: 9.9-16.4 or premature (median 15.4%, IQR: 10.6-19.1 were similar across geographic region, study design, and institutional setting. The median incidence of MCM per 1,000 live births was 14.4 (IQR: 5.5-17.6, with the musculoskeletal system comprising 30%.Some clinical trials assessing whether maternal immunization can improve pregnancy and young infant outcomes in the developing world have made ethics-based decisions not to use a pure placebo control. Consequently, reliable background rates of adverse pregnancy outcomes are necessary to distinguish between vaccine benefits and safety concerns. Local studies that quantify population-based background rates of

  18. Systematic review of clinical trials assessing pharmacological properties of Salvia species on memory, cognitive impairment and Alzheimer's disease.

    Science.gov (United States)

    Miroddi, Marco; Navarra, Michele; Quattropani, Maria C; Calapai, Fabrizio; Gangemi, Sebastiano; Calapai, Gioacchino

    2014-06-01

    Salvia officinalis L. and Salvia lavandulaefolia L. have a longstanding use as traditional herbal remedies that can enhance memory and improve cognitive functions. Pharmacological actions of S. officinalis and S. lavandulaefolia on healthy subjects and on patients suffering of cognitive decline have been investigated. Aim of this review was to summarize published clinical trials assessing effectiveness and safety of S. officinalis and S. lavandulaefolia in the enhancement of cognitive performance in healthy subjects and neurodegenerative illnesses. Furthermore, to purchase a more complete view on safety of S. officinalis and S. lavandulaefolia, we collected and discussed articles regarding toxicity and adverse reactions. Eight clinical studies investigating on acute effects of S. officinalis on healthy subjects were included in the review. Six studies investigated on the effects of S. officinalis and S. lavandaeluaefolia on cognitive performance in healthy subjects. The two remaining were carried out to study the effects of sage on Azheimer's disease. Our review shows that S. officinalis and S. lavandulaefolia exert beneficial effects by enhancing cognitive performance both in healthy subjects and patients with dementia or cognitive impairment and is safe for this indication. Unfortunately, promising beneficial effects are debased by methodological issues, use of different herbal preparations (extracts, essential oil, use of raw material), lack of details on herbal products used. We believe that sage promising effects need further higher methodological standard clinical trials. © 2014 John Wiley & Sons Ltd.

  19. A randomized, controlled trial to assess short-term black pepper consumption on 24-hour energy expenditure and substrate utilization

    Directory of Open Access Journals (Sweden)

    Annalouise O’Connor

    2013-10-01

    Full Text Available ABSTRACTBackground: Thermogenic ingredients may play a role in weight management. In vitro and rodent work suggests that components of black pepper may impact energy expenditure, and in humans, other TPRV1 agonists e.g. capsaicin, augment EE. Objectives: To determine the impact of BP on 24-hour EE, respiratory quotient, and biochemical markers of metabolism and satiety, a randomized, controlled, cross-over study of black pepper (0.5mg/meal versus no pepper control was conducted in post-menopausal women. Subjects spent two 24-hour periods in a whole room indirect calorimeter. Results: Post-meal glucose, insulin, gut peptides and catecholamines were measured. Energy expenditure, respiratory quotient, or biochemical markers assessed did not differ significantly between the black pepper and no pepper control study days. Conclusions: Our findings do not support a role for black pepper in modulating energy expenditure in overweight postmenopausal women. Future work targeting alternative populations, administering black pepper in the fasted state, or in combination with other spices, may reveal the thermogenic effect of this spice.Trial registration: This trial was registered at clinicaltrials.gov (NCT01729143.Key words: Black pepper, piperine, energy expenditure, metabolic chamber

  20. Automated single-trial assessment of laser-evoked potentials as an objective functional diagnostic tool for the nociceptive system.

    Science.gov (United States)

    Hatem, S M; Hu, L; Ragé, M; Gierasimowicz, A; Plaghki, L; Bouhassira, D; Attal, N; Iannetti, G D; Mouraux, A

    2012-12-01

    To assess the clinical usefulness of an automated analysis of event-related potentials (ERPs). Nociceptive laser-evoked potentials (LEPs) and non-nociceptive somatosensory electrically-evoked potentials (SEPs) were recorded in 37 patients with syringomyelia and 21 controls. LEP and SEP peak amplitudes and latencies were estimated using a single-trial automated approach based on time-frequency wavelet filtering and multiple linear regression, as well as a conventional approach based on visual inspection. The amplitudes and latencies of normal and abnormal LEP and SEP peaks were identified reliably using both approaches, with similar sensitivity and specificity. Because the automated approach provided an unbiased solution to account for average waveforms where no ERP could be identified visually, it revealed significant differences between patients and controls that were not revealed using the visual approach. The automated analysis of ERPs characterized reliably and objectively LEP and SEP waveforms in patients. The automated single-trial analysis can be used to characterize normal and abnormal ERPs with a similar sensitivity and specificity as visual inspection. While this does not justify its use in a routine clinical setting, the technique could be useful to avoid observer-dependent biases in clinical research. Copyright © 2012 International Federation of Clinical Neurophysiology. Published by Elsevier Ireland Ltd. All rights reserved.

  1. Effect of Engaging Trainees by Assessing Peer Performance: A Randomised Controlled Trial Using Simulated Patient Scenarios

    Directory of Open Access Journals (Sweden)

    Charlotte Loumann Krogh

    2014-01-01

    Full Text Available Introduction. The aim of this study was to explore the learning effect of engaging trainees by assessing peer performance during simulation-based training. Methods. Eighty-four final year medical students participated in the study. The intervention involved trainees assessing peer performance during training. Outcome measures were in-training performance and performance, both of which were measured two weeks after the course. Trainees’ performances were videotaped and assessed by two expert raters using a checklist that included a global rating. Trainees’ satisfaction with the training was also evaluated. Results. The intervention group obtained a significantly higher overall in-training performance score than the control group: mean checklist score 20.87 (SD 2.51 versus 19.14 (SD 2.65 P=0.003 and mean global rating 3.25 SD (0.99 versus 2.95 (SD 1.09 P=0.014. Postcourse performance did not show any significant difference between the two groups. Trainees who assessed peer performance were more satisfied with the training than those who did not: mean 6.36 (SD 1.00 versus 5.74 (SD 1.33 P=0.025. Conclusion. Engaging trainees in the assessment of peer performance had an immediate effect on in-training performance, but not on the learning outcome measured two weeks later. Trainees had a positive attitude towards the training format.

  2. Protocol of the Definition for the Assessment of Time-to-event Endpoints in CANcer trials (DATECAN) project: formal consensus method for the development of guidelines for standardised time-to-event endpoints' definitions in cancer clinical trials.

    Science.gov (United States)

    Bellera, Carine A; Pulido, Marina; Gourgou, Sophie; Collette, Laurence; Doussau, Adélaïde; Kramar, Andrew; Dabakuyo, Tienhan Sandrine; Ouali, Monia; Auperin, Anne; Filleron, Thomas; Fortpied, Catherine; Le Tourneau, Christophe; Paoletti, Xavier; Mauer, Murielle; Mathoulin-Pélissier, Simone; Bonnetain, Franck

    2013-03-01

    In randomised phase III cancer clinical trials, the most objectively defined and only validated time-to-event endpoint is overall survival (OS). The appearance of new types of treatments and the multiplication of lines of treatment have resulted in the use of surrogate endpoints for overall survival such as progression-free survival (PFS), or time-to-treatment failure. Their development is strongly influenced by the necessity of reducing clinical trial duration, cost and number of patients. However, while these endpoints are frequently used, they are often poorly defined and definitions can differ between trials which may limit their use as primary endpoints. Moreover, this variability of definitions can impact on the trial's results by affecting estimation of treatments' effects. The aim of the Definition for the Assessment of Time-to-event Endpoints in CANcer trials (DATECAN) project is to provide recommendations for standardised definitions of time-to-event endpoints in randomised cancer clinical trials. We will use a formal consensus methodology based on experts' opinions which will be obtained in a systematic manner. Definitions will be independently developed for several cancer sites, including pancreatic, breast, head and neck and colon cancer, as well as sarcomas and gastrointestinal stromal tumours (GISTs). The DATECAN project should lead to the elaboration of recommendations that can then be used as guidelines by researchers participating in clinical trials. This process should lead to a standardisation of the definitions of commonly used time-to-event endpoints, enabling appropriate comparisons of future trials' results. Copyright © 2012 Elsevier Ltd. All rights reserved.

  3. The design and development of a complex multifactorial falls assessment intervention for falls prevention: The Prevention of Falls Injury Trial (PreFIT).

    Science.gov (United States)

    Bruce, Julie; Ralhan, Shvaita; Sheridan, Ray; Westacott, Katharine; Withers, Emma; Finnegan, Susanne; Davison, John; Martin, Finbarr C; Lamb, Sarah E

    2017-06-01

    This paper describes the design and development of a complex multifactorial falls prevention (MFFP) intervention for implementation and testing within the framework of a large UK-based falls prevention randomised controlled trial (RCT). A complex intervention was developed for inclusion within the Prevention of Falls Injury Trial (PreFIT), a multicentre pragmatic RCT. PreFIT aims to compare the clinical and cost-effectiveness of three alternative primary care falls prevention interventions (advice, exercise and MFFP), on outcomes of fractures and falls. Community-dwelling adults, aged 70 years and older, were recruited from primary care in the National Health Service (NHS), England. Development of the PreFIT MFFP intervention was informed by the existing evidence base and clinical guidelines for the assessment and management of falls in older adults. After piloting and modification, the final MFFP intervention includes seven falls risk factors: a detailed falls history interview with consideration of 'red flags'; assessment of balance and gait; vision; medication screen; cardiac screen; feet and footwear screen and home environment assessment. This complex intervention has been fully manualised with clear, documented assessment and treatment pathways for each risk factor. Each risk factor is assessed in every trial participant referred for MFFP. Referral for assessment is based upon a screening survey to identify those with a history of falling or balance problems. Intervention delivery can be adapted to the local setting. This complex falls prevention intervention is currently being tested within the framework of a large clinical trial. This paper adheres to TIDieR and CONSORT recommendations for the comprehensive and explicit reporting of trial interventions. Results from the PreFIT study will be published in due course. The effectiveness and cost-effectiveness of the PreFIT MFFP intervention, compared to advice and exercise, on the prevention of falls and

  4. Assessing a cognitive music training for older participants: a randomised controlled trial.

    Science.gov (United States)

    Biasutti, Michele; Mangiacotti, Anthony

    2018-02-01

    In a randomised controlled trial, we investigated whether a cognitive training based on rhythm-music and music improvisation exercises had positive effects on executive functions in older participants. Thirty-five residents in a guest home with mild-moderate cognitive impairment and healthy ageing were randomly assigned to an experimental group (n = 18) featuring cognitive music training composed of 12 bi-weekly 70-min sessions, and a control group (n = 17) attended 12 bi-weekly 45-min sessions of gymnastic activities offered by the institute. A neuropsychological test battery was administered at baseline and at the end of treatment, including the Mini-Mental State Examination, verbal fluency test, Trail Making Test A, attentional matrices test and clock-drawing test. Pre-test and post-test comparison showed a significant improvement for the experimental group reflected in the Mini-Mental State Examination (F(1,33) = 13.906; p music-rhythmic exercises and music improvisation exercises is associated with improved cognitive functions in older people with mild-moderate cognitive impairment regardless of the individual's degree of cognitive reserve. Copyright © 2017 John Wiley & Sons, Ltd. Copyright © 2017 John Wiley & Sons, Ltd.

  5. An assessment of the quality of reporting randomised controlled trials published in paediatric dentistry journals.

    Science.gov (United States)

    Rajasekharan, S; Vandenbulcke, J; Martens, L

    2015-04-01

    The objectives of this study are to compare the quality of reporting of randomised controlled trials (RCTs) published in 2011 and 2012 within five paediatric dentistry journals. RCTs published in the years 2011 and 2012 were hand-searched by one reviewer. After randomisation and blinding, these journals were independently scored by two blinded reviewers based on the CONSORT 2010 checklist. A total of 59 articles were included for analysis and 70 criteria were scored dichotomously as '1' when reported and '0' when not reported. Descriptive statistics and one-way ANOVA tests were performed. The Gwets AC1 Inter rater reliability coefficient was calculated as 0.85 (95 % C.I 0.84-0.86) indicating excellent correlation between the two reviewers. Only 19 articles (32.2 %) reported more than half (35/70) of the expected criteria. Descriptive statistics showed that sections such as introduction, results and discussion were reported better than abstract, materials and methods and other information. One-way ANOVA tests showed no significant difference (p > 0.05) in the reporting of criteria across different journals and there was also no significant difference between the articles published in 2011 and 2012 (p > 0.05). The general quality of reporting of RCTs in paediatric dentistry journals was inadequate. Authors, reviewers and journal guidelines must work together towards a common goal for improving the quality of reporting of RCTs.

  6. The impact of the carer support needs assessment tool (CSNAT in community palliative care using a stepped wedge cluster trial.

    Directory of Open Access Journals (Sweden)

    Samar M Aoun

    Full Text Available Family caregiving towards the end-of-life entails considerable emotional, social, financial and physical costs for caregivers. Evidence suggests that good support can improve caregiver psychological outcomes. The primary aim of this study was to investigate the impact of using the carer support needs assessment tool (CSNAT, as an intervention to identify and address support needs in end of life home care, on family caregiver outcomes. A stepped wedge design was used to trial the CSNAT intervention in three bases of Silver Chain Hospice Care in Western Australia, 2012-14. The intervention consisted of at least two visits from nurses (2-3 weeks apart to identify, review and address caregivers' needs. The outcome measures for the intervention and control groups were caregiver strain and distress as measured by the Family Appraisal of Caregiving Questionnaire (FACQ-PC, caregiver mental and physical health as measured by SF-12v2, and caregiver workload as measured by extent of caregiver assistance with activities of daily living, at baseline and follow up. Total recruitment was 620. There was 45% attrition for each group between baseline and follow-up mainly due to patient deaths resulting in 322 caregivers completing the study (233 in the intervention group and 89 in the control group. At follow-up, the intervention group showed significant reduction in caregiver strain relative to controls, p=0.018, d=0.348 (95% CI 0.25 to 0.41. Priority support needs identified by caregivers included knowing what to expect in the future, having time for yourself in the day and dealing with your feelings and worries. Despite the challenges at the clinician, organisational and trial levels, the CSNAT intervention led to an improvement in caregiver strain. Effective implementation of an evidence-informed and caregiver-led tool represents a necessary step towards helping palliative care providers better assess and address caregiver needs, ensuring adequate family

  7. Evaluation of an online interactive Diabetes Needs Assessment Tool (DNAT versus online self-directed learning: a randomised controlled trial

    Directory of Open Access Journals (Sweden)

    Kellner Thomas

    2011-06-01

    Full Text Available Abstract Background Methods for the dissemination, understanding and implementation of clinical guidelines need to be examined for their effectiveness to help doctors integrate guidelines into practice. The objective of this randomised controlled trial was to evaluate the effectiveness of an interactive online Diabetes Needs Assessment Tool (DNAT (which constructs an e-learning curriculum based on individually identified knowledge gaps, compared with self-directed e-learning of diabetes guidelines. Methods Health professionals were randomised to a 4-month learning period and either given access to diabetes learning modules alone (control group or DNAT plus learning modules (intervention group. Participants completed knowledge tests before and after learning (primary outcome, and surveys to assess the acceptability of the learning and changes to clinical practice (secondary outcomes. Results Sixty four percent (677/1054 of participants completed both knowledge tests. The proportion of nurses (5.4% was too small for meaningful analysis so they were excluded. For the 650 doctors completing both tests, mean (SD knowledge scores increased from 47.4% (12.6 to 66.8% (11.5 [intervention group (n = 321, 64%] and 47.3% (12.9 to 67.8% (10.8 [control group (n = 329, 66%], (ANCOVA p = 0.186. Both groups were satisfied with the usability and usefulness of the learning materials. Seventy seven percent (218/284 of the intervention group reported combining the DNAT with the recommended reading materials was "very useful"/"useful". The majority in both groups (184/287, 64.1% intervention group and 206/299, 68.9% control group [95% CI for the difference (-2.8 to 12.4] reported integrating the learning into their clinical practice. Conclusions Both groups experienced a similar and significant improvement in knowledge. The learning materials were acceptable and participants incorporated the acquired knowledge into practice. Trial registration ISRCTN: ISRCTN67215088

  8. An ECVAG trial on assessment of oxidative damage to DNA measured by the comet assay

    DEFF Research Database (Denmark)

    Johansson, Clara; Møller, Peter; Forchhammer, Lykke

    2010-01-01

    The increasing use of single cell gel electrophoresis (the comet assay) highlights its popularity as a method for detecting DNA damage, including the use of enzymes for assessment of oxidatively damaged DNA. However, comparison of DNA damage levels between laboratories can be difficult due to dif...

  9. Randomized controlled trial assessing a traditional Chinese medicine remedy in the treatment of primary dysmenorrhea

    NARCIS (Netherlands)

    Kennedy, S.; Jin, X.; Yu, H.; Zhong, S.; Magill, P.; Vliet, T. van; Kistemaker, C.; Voors, C.; Pasman, W.

    2006-01-01

    A proof-of-concept study to assess the safety and efficacy of a traditional Chinese medicine formula as treatment for primary dysmenorrhea showed no statistically significant benefit over placebo. However, some efficacy parameters suggested possible superiority of the active treatment and so a

  10. HElmet therapy Assessment in infants with Deformed Skulls (HEADS): protocol for a randomised controlled trial

    NARCIS (Netherlands)

    Wijk, R.M. van; Boere-Boonekamp, M.M.; Groothuis-Oudshoorn, C.G. van; Vlimmeren, L.A. van; IJzerman, M.J.

    2012-01-01

    In The Netherlands helmet therapy is a commonly used treatment in infants with skull deformation (deformational plagiocephaly or deformational brachycephaly). However, evidence on the effectiveness of this treatment is lacking. The HEADS study (Helmet therapy Assessment in Deformed Skulls) aims to

  11. Standardised Observation Analogue Procedure (SOAP) for Assessing Parent and Child Behaviours in Clinical Trials

    Science.gov (United States)

    Johnson, Cynthia R.; Butter, Eric M.; Handen, Benjamin L.; Sukhodolsky, Denis G.; Mulick, James; Lecavalier, Luc; Aman, Michael G.; Arnold, Eugene L.; Scahill, Lawrence; Swiezy, Naomi; Sacco, Kelley; Stigler, Kimberly A.; McDougle, Christopher J.

    2009-01-01

    Background: Observational measures of parent and child behaviours have a long history in child psychiatric and psychological intervention research, including the field of autism and developmental disability. We describe the development of the Standardised Observational Analogue Procedure (SOAP) for the assessment of parent-child behaviour before…

  12. Safety and nutritional assessment of GM plants and derived food and feed: the role of animal feeding trials.

    Science.gov (United States)

    2008-03-01

    In this report the various elements of the safety and nutritional assessment procedure for genetically modified (GM) plant derived food and feed are discussed, in particular the potential and limitations of animal feeding trials for the safety and nutritional testing of whole GM food and feed. The general principles for the risk assessment of GM plants and derived food and feed are followed, as described in the EFSA guidance document of the EFSA Scientific Panel on Genetically Modified Organisms. In Section 1 the mandate, scope and general principles for risk assessment of GM plant derived food and feed are discussed. Products under consideration are food and feed derived from GM plants, such as maize, soybeans, oilseed rape and cotton, modified through the introduction of one or more genes coding for agronomic input traits like herbicide tolerance and/or insect resistance. Furthermore GM plant derived food and feed, which have been obtained through extensive genetic modifications targeted at specific alterations of metabolic pathways leading to improved nutritional and/or health characteristics, such as rice containing beta-carotene, soybeans with enhanced oleic acid content, or tomato with increased concentration of flavonoids, are considered. The safety assessment of GM plants and derived food and feed follows a comparative approach, i.e. the food and feed are compared with their non-GM counterparts in order to identify intended and unintended (unexpected) differences which subsequently are assessed with respect to their potential impact on the environment, safety for humans and animals, and nutritional quality. Key elements of the assessment procedure are the molecular, compositional, phenotypic and agronomic analysis in order to identify similarities and differences between the GM plant and its near isogenic counterpart. The safety assessment is focussed on (i) the presence and characteristics of newly expressed proteins and other new constituents and possible

  13. Assessment of postoperative pain after reciprocating or rotary NiTi instrumentation of root canals: a randomized, controlled clinical trial.

    Science.gov (United States)

    Relvas, João Bosko Formigas; Bastos, Mariana Mena Barreto; Marques, André Augusto Franco; Garrido, Angela Delfina Bitencourt; Sponchiado, Emílio Carlos

    2016-11-01

    The aim of this study was to assess postoperative pain in a prospective randomized clinical trial comparing two groups, using the Reciproc® system in one group and the ProTaper® rotary system in the other. The study included 78 male patients, aged 18-64 years (mean age of 26 years), with asymptomatic pulp necrosis in mandibular molar teeth (n = 78). The single-session endodontic treatment was performed by a single operator specialized in Endodontics. Mechanical preparation of the root canals was performed using the ProTaper® and Reciproc® instrumentation techniques. Postoperative pain was recorded using a verbal rating scale (VRS) and verbal description with well-defined categories at the three following time intervals: 24 h, 72 h, and 7 days after the endodontic procedure. The assessment of postoperative pain was recorded as no pain, mild pain, moderate pain, and severe pain or flare-up. Data were analyzed using the nonparametric Mann-Whitney test with the aid of the STATA® software. The incidence of postoperative pain in the ProTaper group (PT) 24 h after the endodontic procedure was 17.9 and 5.1 % after 72 h. In the Reciproc group (RP), the incidence after 24 h was 15.3 and 2.5 % after 72 h. No patients presented severe pain at the time intervals assessed. No significant difference (p > 0.05) in postoperative pain was found between the ProTaper® and Reciproc® instrumentation technique during endodontic treatment in this study. According to our findings and the results of the clinical trial, the occurrence of postoperative pain was low and similar between the reciprocating and rotary techniques during the time intervals assessed. These results are different from basic laboratory studies that affirm that the reciprocating techniques tend to promote more postoperative pain since extrusion of debris is greater.

  14. Assessment of the quality of reporting of randomised controlled trials in otorhinolaryngologic literature - adherence to the CONSORT statement

    NARCIS (Netherlands)

    Peters, Jeroen P M; Hooft, Lotty; Grolman, Wilko; Stegeman, Inge

    2015-01-01

    BACKGROUND: Randomised Controlled Trials (RCTs) are the preferred study design when comparing therapeutical interventions in medicine. To improve clarity, consistency and transparency of reporting RCTs, the Consolidated Standards of Reporting Trials (CONSORT) statement was developed. OBJECTIVES: (1)

  15. Are randomised controlled trials positivist? Reviewing the social science and philosophy literature to assess positivist tendencies of trials of social interventions in public health and health services.

    Science.gov (United States)

    Bonell, Chris; Moore, Graham; Warren, Emily; Moore, Laurence

    2018-04-19

    We have previously proposed that trials of social interventions can be done within a "realist" research paradigm. Critics have countered that such trials are irredeemably positivist and asked us to explain our philosophical position. We set out to explore what is meant by positivism and whether trials adhere to its tenets (of necessity or in practice) via a narrative literature review of social science and philosophical discussions of positivism, and of the trials literature and three case studies of trials. The philosophical literature described positivism as asserting: (1) the epistemic primacy of sensory information; (2) the requirement that theoretical terms equate with empirical terms; (3) the aim of developing universal laws; and (4) the unity of method between natural and social sciences. Regarding (1), it seems that rather than embodying the epistemic primacy of sensory data, randomised controlled trials (RCTs) of social interventions in health embrace an anti-positivist approach aiming to test hypotheses derived deductively from prior theory. Considering (2), while some RCTs of social interventions appear to limit theorisation to concepts with empirical analogues, others examine interventions underpinned by theories engaging with mechanisms and contextual contingencies not all of which can be measured. Regarding (3), while some trialists and reviewers in the health field do limit their role to estimating statistical trends as a mechanistic form of generalisation, this is not an inevitable feature of RCT-based research. Trials of social interventions can instead aim to generalise at the level of theory which specifies how mechanisms are contingent on context. In terms of (4), while RCTs are used to examine biomedical as well as social interventions in health, RCTs of social interventions are often distinctive in using qualitative analyses of data on participant accounts to examine questions of meaning and agency not pursued in the natural sciences. We

  16. Elemental characterization of new Polish and U.S. NIST geological, environmental and biological reference materials by neutron activation analysis and comments on the methodology of interlaboratory comparisons

    International Nuclear Information System (INIS)

    Kucera, J.

    1995-01-01

    Neutron activation analysis (NAA) has been extensively used in interlaboratory comparisons aiming at the certification of new Polish geological, environmental and botanical materials (RMs): Apatite Concentrate CTA-AC-1, Fine Fly Ash CTA-FFA-1, Oriental Tobacco Leaves CTA-OTL-1, Virginia Tobacco Leaves CTA-VTL-2. For quality assurance and traceability purposes, already existing RMs of similar composition, such as Apatite Ore AR and NIST SRM-2704 Buffalo River Sediment were analyzed in our Laboratory as well as NIST SRM-1573a Tomato Leaves which was assayed as an intercomparison sample prior to the certification at the NIST. Results obtained for a total of 47 elements are reported and critically evaluated. Problems of organizing and evaluating interlaboratory comparisons are also discussed. (author). 28 refs, 1 fig., 8 tabs

  17. A Field Trial to Assess a Blood-Stage Malaria Vaccine

    Science.gov (United States)

    Thera, Mahamadou A.; Doumbo, Ogobara K.; Coulibaly, Drissa; Laurens, Matthew B.; Ouattara, Amed; Kone, Abdoulaye K.; Guindo, Ando B.; Traore, Karim; Traore, Idrissa; Kouriba, Bourema; Diallo, Dapa A.; Diarra, Issa; Daou, Modibo; Dolo, Amagana; Tolo, Youssouf; Sissoko, Mahamadou S.; Niangaly, Amadou; Sissoko, Mady; Takala-Harrison, Shannon; Lyke, Kirsten E.; Wu, Yukun; Blackwelder, William C.; Godeaux, Olivier; Vekemans, Johan; Dubois, Marie-Claude; Ballou, W. Ripley; Cohen, Joe; Thompson, Darby; Dube, Tina; Soisson, Lorraine; Diggs, Carter L.; House, Brent; Lanar, David E.; Dutta, Sheetij; Heppner, D. Gray; Plowe, Christopher V.

    2011-01-01

    BACKGROUND Blood-stage malaria vaccines are intended to prevent clinical disease. The malaria vaccine FMP2.1/AS02A, a recombinant protein based on apical membrane antigen 1 (AMA1) from the 3D7 strain of Plasmodium falciparum, has previously been shown to have immunogenicity and acceptable safety in Malian adults and children. METHODS In a double-blind, randomized trial, we immunized 400 Malian children with either the malaria vaccine or a control (rabies) vaccine and followed them for 6 months. The primary end point was clinical malaria, defined as fever and at least 2500 parasites per cubic millimeter of blood. A secondary end point was clinical malaria caused by parasites with the AMA1 DNA sequence found in the vaccine strain. RESULTS The cumulative incidence of the primary end point was 48.4% in the malaria-vaccine group and 54.4% in the control group; efficacy against the primary end point was 17.4% (hazard ratio for the primary end point, 0.83; 95% confidence interval [CI], 0.63 to 1.09; P = 0.18). Efficacy against the first and subsequent episodes of clinical malaria, as defined on the basis of various parasite-density thresholds, was approximately 20%. Efficacy against clinical malaria caused by parasites with AMA1 corresponding to that of the vaccine strain was 64.3% (hazard ratio, 0.36; 95% CI, 0.08 to 0.86; P = 0.03). Local reactions and fever after vaccination were more frequent with the malaria vaccine. CONCLUSIONS On the basis of the primary end point, the malaria vaccine did not provide significant protection against clinical malaria, but on the basis of secondary results, it may have strain-specific efficacy. If this finding is confirmed, AMA1 might be useful in a multicomponent malaria vaccine. PMID:21916638

  18. Airflow distribution with manual hyperinflation as assessed through gamma camera imaging: a crossover randomised trial.

    Science.gov (United States)

    van Aswegen, H; van Aswegen, A; Raan, H Du; Toit, R Du; Spruyt, M; Nel, R; Maleka, M

    2013-06-01

    Manual hyperinflation (MHI) has been shown to improve lung compliance, reduce airway resistance, and enhance secretion removal and peak expiratory flow. The aims of this study were to investigate whether there is a difference in airflow distribution through patients' lungs when using the Laerdal and Mapleson-C circuits at a set level of positive end-expiratory pressure (PEEP), and to establish whether differences in lung compliance and haemodynamic status exist when patients are treated with both these MHI circuits. Crossover randomised controlled trial. Adult multidisciplinary intensive care unit (ICU) at an academic hospital. Fifteen adult patients were recruited and served as their own controls. In the Nuclear Medicine Department, MHI with PEEP 7.5 cmH(2)O was performed in the supine position (Day 1) with either Laerdal or Mapleson-C circuits, in a random order, while technetium-99m (Tc-99m) aerosol was administered and images were taken with a gamma camera. Changes in heart rate (HR), mean arterial pressure (MAP) and dynamic lung compliance (C(D)) were documented at baseline, immediately after return to ICU, and 10, 20 and 30 minutes after return to ICU. The alternative circuit was used on Day 2. Tc-99m deposition was greater in the right lung field (62% and 63% for Laerdal and Mapleson-C circuits, respectively) than the left lung field (38% and 37%, respectively) for all patients, and least deposition occurred in the left lower segments (6% and 6%, respectively). No differences in Tc-99m deposition in the lungs, HR, MAP or C(D) were noted between the two MHI circuits. Airflow distribution through patients' lungs was similar when the Laerdal and Mapleson-C MHI circuits were compared using a set level of PEEP in the supine position. Copyright © 2012 Chartered Society of Physiotherapy. Published by Elsevier Ltd. All rights reserved.

  19. Robustness Assessments Are Needed to Reduce Bias in Meta-Analyses That Include Zero-Event Randomized Trials

    NARCIS (Netherlands)

    Keus, F.; Wetterslev, J.; Gluud, C.; Gooszen, H. G.; van Laarhoven, C. J. H. M.

    OBJECTIVES: Meta-analysis of randomized trials with binary data can use a variety of statistical methods. Zero-event trials may create analytic problems. We explored how different methods may impact inferences from meta-analyses containing zero-event trials. METHODS: Five levels of statistical

  20. Robustness assessments are needed to reduce bias in meta-analyses that include zero-event randomized trials.

    NARCIS (Netherlands)

    Keus, F.; Wetterslev, J.; Gluud, C.; Gooszen, H.G.; Laarhoven, C.J.H.M. van

    2009-01-01

    OBJECTIVES: Meta-analysis of randomized trials with binary data can use a variety of statistical methods. Zero-event trials may create analytic problems. We explored how different methods may impact inferences from meta-analyses containing zero-event trials. METHODS: Five levels of statistical

  1. Risk of bias assessment of randomised controlled trials in high-impact ophthalmology journals and general medical journals: a systematic review.

    Science.gov (United States)

    Joksimovic, Lazar; Koucheki, Robert; Popovic, Marko; Ahmed, Yusuf; Schlenker, Matthew B; Ahmed, Iqbal Ike K

    2017-10-01

    Evidence-based treatments in ophthalmology are often based on the results of randomised controlled trials. Biased conclusions from randomised controlled trials may lead to inappropriate management recommendations. This systematic review investigates the prevalence of bias risk in randomised controlled trials published in high-impact ophthalmology journals and ophthalmology trials from general medical journals. Using Ovid MEDLINE, randomised controlled trials in the top 10 high-impact ophthalmology journals in 2015 were systematically identified and critically appraised for the prevalence of bias risk. Included randomised controlled trials were assessed in all domains of bias as defined by the Cochrane Collaboration. In addition, the prevalence of conflict of interest and industry sponsorship was investigated. A comparison with ophthalmology articles from high-impact general medical journals was performed. Of the 259 records that were screened from ophthalmology-specific journals, 119 trials met all inclusion criteria and were critically appraised. In total, 29.4% of domains had an unclear risk, 13.8% had a high risk and 56.8% had a low risk of bias. In comparison, ophthalmology articles from general medical journals had a lower prevalence of unclear risk (17.1%), higher prevalence of high risk (21.9%) and a higher prevalence of low risk domains (61.9%). Furthermore, 64.7% of critically appraised trials from ophthalmology-specific journals did not report any conflicts of interest, while 70.6% did not report an industry sponsor of their trial. In closing, it is essential that authors, peer reviewers and readers closely follow published risk of bias guidelines. © Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2017. All rights reserved. No commercial use is permitted unless otherwise expressly granted.

  2. Impact of self-assessment questions and learning styles in Web-based learning: a randomized, controlled, crossover trial.

    Science.gov (United States)

    Cook, David A; Thompson, Warren G; Thomas, Kris G; Thomas, Matthew R; Pankratz, V Shane

    2006-03-01

    To determine the effect of self-assessment questions on learners' knowledge and format preference in a Web-based course, and investigate associations between learning styles and outcomes. The authors conducted a randomized, controlled, crossover trial in the continuity clinics of the Mayo-Rochester internal medicine residency program during the 2003-04 academic year. Case-based self-assessment questions were added to Web-based modules covering topics in ambulatory internal medicine. Participants completed two modules with questions and two modules without questions, with sequence randomly assigned. Outcomes included knowledge assessed after each module, format preference, and learning style assessed using the Index of Learning Styles. A total of 121 of 146 residents (83%) consented. Residents had higher test scores when using the question format (mean +/- standard error, 78.9% +/- 1.0) than when using the standard format (76.2% +/- 1.0, p = .006). Residents preferring the question format scored higher (79.7% +/- 1.1) than those preferring standard (69.5% +/- 2.3, p 3.0, p = .003 and p = .033, respectively). Sixty-five of 78 residents (83.3%, 95% CI 73.2-90.8%) preferred the question format. Learning styles were not associated with preference (p > .384). Although the question format took longer than the standard format (60.4 +/- 3.6 versus 44.3 +/- 3.3 minutes, p Web-based learning and "traditional" educational activities. Future research, in both Web-based learning and other teaching modalities, should focus on further defining the effectiveness of selected instructional methods in specific learning contexts.

  3. Instructional Design for Assessment of Dental Esthetic Treatment Needs in a Indian Undergraduate School: A Randomised Controlled Trial.

    Science.gov (United States)

    Sangappa, Sunila B; Mehendale, Avinash V

    2014-12-01

    In the recent years esthetic dentistry has been the area of focus amongst the public. Esthetics is an important dimension in dental practice and the upcoming dentists need to be enabled to demonstrate their competencies for an efficient clinical outcome. The purpose of this study was to institute a cultural change within traditional didactic dental education towards student centred learning to cope up with the accelerating pace of medical technological change and achieving positive impact on patient care and patient satisfaction. Intervention that was considered for the project included David Merrill's first principles of instruction. A randomized controlled trial was conducted with all the students from four cohorts of final year dental undergraduate students, divided into an intervention group (n = 40) and a control group (n = 40). A professional assessment questionnaire is used to evaluate the relationship between the students and professional's assessment of esthetic treatment needs. The results of the study indicated that the ranking of the most and least noticeable dental features differed significantly (p = 0.0061) between the intervention and non intervention group and the indicates the intervention group to be in better agreement with professional assessment than the non intervention group of students with z value of 2.7435. The relative agreement between intervention group of undergraduate students and the professional assessment of esthetic treatment need shows the importance of intervention of Merrill's first principles of instruction in learning, emphasising the significance of PBL and therefore indicating a positive impact on successful esthetic treatment for patients.

  4. Validation of a new enzyme-linked immunosorbent assay to detect the triggering proteins and peptides for celiac disease: interlaboratory study.

    Science.gov (United States)

    Mujico, Jorge R; Dekking, Liesbeth; Kooy-Winkelaar, Yvonne; Verheijen, Ron; van Wichen, Piet; Streppel, Lucia; Sajic, Nermin; Drijfhout, Jan W; Koning, Frits

    2012-01-01

    The performance of Gluten-Tec (EuroProxima, Arnhem, The Netherlands) was tested through an interlaboratory study in accordance with AOAC guidelines. Gluten-Tec is a competitive ELISA that detects an immunostimulatory epitope of a-gliadin in dietary food for celiacs. Fifteen laboratories, representing 14 different countries, announced their interest in taking part in this study. Of the 12 laboratories that sent the results within the established timeframe, two submitted inappropriate standard curves and were excluded from the statistical analysis. Four different food matrixes (rice-based baby food, maize bread, chocolate cake mix, and beer) were selected for preparing the test samples. Two gliadin extraction procedures were used: the conventional 60% ethanol, and a new method based on the reducing reagent dithiothreitol. The 38 samples (19 blind duplicates) tested in this study were prepared by diluting the different extracts in order to cover a wide range of gliadin levels. Both sample extraction and dilution were performed by EuroProxima; the present interlaboratory study was focused only on testing the ELISA part of the Gluten-Tec kit protocol. Repeatability values (within-laboratory variance), expressed as RSD(r) ranged from 6.2 to 25.7%, while reproducibility values (interlaboratory variance), expressed as RSD(R), ranged from 10.6 to 45.9%. Both statistical parameters were in the acceptable range of ELISAs under these conditions, and the method will be presented to the Codex Alimentarius as a preferred method for gluten analysis.

  5. Guidelines for time-to-event end point definitions in sarcomas and gastrointestinal stromal tumors (GIST) trials: results of the DATECAN initiative (Definition for the Assessment of Time-to-event Endpoints in CANcer trials)†.

    Science.gov (United States)

    Bellera, C A; Penel, N; Ouali, M; Bonvalot, S; Casali, P G; Nielsen, O S; Delannes, M; Litière, S; Bonnetain, F; Dabakuyo, T S; Benjamin, R S; Blay, J-Y; Bui, B N; Collin, F; Delaney, T F; Duffaud, F; Filleron, T; Fiore, M; Gelderblom, H; George, S; Grimer, R; Grosclaude, P; Gronchi, A; Haas, R; Hohenberger, P; Issels, R; Italiano, A; Jooste, V; Krarup-Hansen, A; Le Péchoux, C; Mussi, C; Oberlin, O; Patel, S; Piperno-Neumann, S; Raut, C; Ray-Coquard, I; Rutkowski, P; Schuetze, S; Sleijfer, S; Stoeckle, E; Van Glabbeke, M; Woll, P; Gourgou-Bourgade, S; Mathoulin-Pélissier, S

    2015-05-01

    The use of potential surrogate end points for overall survival, such as disease-free survival (DFS) or time-to-treatment failure (TTF) is increasingly common in randomized controlled trials (RCTs) in cancer. However, the definition of time-to-event (TTE) end points is rarely precise and lacks uniformity across trials. End point definition can impact trial results by affecting estimation of treatment effect and statistical power. The DATECAN initiative (Definition for the Assessment of Time-to-event End points in CANcer trials) aims to provide recommendations for definitions of TTE end points. We report guidelines for RCT in sarcomas and gastrointestinal stromal tumors (GIST). We first carried out a literature review to identify TTE end points (primary or secondary) reported in publications of RCT. An international multidisciplinary panel of experts proposed recommendations for the definitions of these end points. Recommendations were developed through a validated consensus method formalizing the degree of agreement among experts. Recommended guidelines for the definition of TTE end points commonly used in RCT for sarcomas and GIST are provided for adjuvant and metastatic settings, including DFS, TTF, time to progression and others. Use of standardized definitions should facilitate comparison of trials' results, and improve the quality of trial design and reporting. These guidelines could be of particular interest to research scientists involved in the design, conduct, reporting or assessment of RCT such as investigators, statisticians, reviewers, editors or regulatory authorities. © The Author 2014. Published by Oxford University Press on behalf of the European Society for Medical Oncology. All rights reserved. For permissions, please email: journals.permissions@oup.com.

  6. Cancer of Oesophagus or Gastricus - New Assessment of Technology of Endosonography (COGNATE): report of pragmatic randomised trial.

    Science.gov (United States)

    Russell, I T; Edwards, R T; Gliddon, A E; Ingledew, D K; Russell, D; Whitaker, R; Yeo, S T; Attwood, S E; Barr, H; Nanthakumaran, S; Park, K G M

    2013-09-01

    Endoscopic ultrasonography is recommended for staging gastro-oesophageal cancers, but has never been evaluated. COGNATE (Cancer of Oesophagus or Gastricus - New Assessment of Technology of Endosonography) therefore aimed to evaluate whether adding 'endoscopic ultrasound' (EUS) to the usual staging algorithm changes treatment, improves (quality-adjusted) survival, and uses resources cost-effectively. Pragmatic parallel-group trial. Patients with gastro-oesophageal cancer received standard staging algorithms. Multidisciplinary teams chose provisional management plans from endoscopic mucosal resection, immediate surgery, surgery after chemotherapy, or chemotherapy and radiotherapy. We used dynamic randomisation to allocate consenting patients remotely by telephone in equal proportions between EUS and not. Thereafter we recorded changes in management plan, use of health-care resources, and three aspects of participant-reported quality of life: generic [measured by European Quality of Life - 5 Dimensions (EQ-5D)], cancer related [Functional Assessment of Cancer Therapy - General scale (FACT-G)] and condition-specific [FACT - Additional Concerns scale (FACT-AC)]. We followed participants regularly until death or the end of the trial - for between 1 and 4.5 years. We devised a quality assurance programme to maintain standards of endosonographic reporting. Eight British hospitals, of which two - one Scottish teaching hospital and one English district general hospital - contributed 80% of participants; we combined the other six for analysis. Patients were eligible if they had a diagnosis of gastro-oesophageal cancer, had not started treatment, were free of metastatic disease, were fit for surgery (even if not planned) and had American Society of Anesthesiologists and World Health Organization grades of less than 3. Intervention group: standard staging algorithm plus EUS; control group: standard staging algorithm. Primary: quality-adjusted survival. Secondary: survival

  7. An online spaced-education game to teach and assess residents: a multi-institutional prospective trial.

    Science.gov (United States)

    Kerfoot, B Price; Baker, Harley

    2012-03-01

    While games are frequently used in resident education, there is little evidence supporting their efficacy. We investigated whether a spaced-education (SE) game can be both a reliable and valid method of assessing residents' knowledge and an effective means of teaching core content. The SE game consisted of 100 validated multiple-choice questions and explanations on core urology content. Residents were sent 2 questions each day via email. Adaptive game mechanics re-sent the questions in 2 or 6 weeks if answered incorrectly and correctly, respectively. Questions expired if not answered on time (appointment dynamic). Residents retired questions by answering each correctly twice in a row (progression dynamic). Competition was fostered by posting relative performance among residents. Main outcomes measures were baseline scores (percentage of questions answered correctly on initial presentation) and completion scores (percentage of questions retired). Nine hundred thirty-one US and Canadian residents enrolled in the 45-week trial. Cronbach alpha reliability for the SE baseline scores was 0.87. Baseline scores (median 62%, interquartile range [IQR] 17%) correlated with scores on the 2008 American Urological Association in-service examination (ISE08), 2009 American Board of Urology qualifying examination (QE09), and ISE09 (r = 0.76, 0.46, and 0.64, respectively; all p games. An SE game is a reliable and valid means to assess residents' knowledge and is a well-accepted method by which residents can master core content. Published by Elsevier Inc.

  8. An online spaced-education game to teach and assess medical students: a multi-institutional prospective trial.

    Science.gov (United States)

    Kerfoot, B Price; Baker, Harley; Pangaro, Louis; Agarwal, Kathryn; Taffet, George; Mechaber, Alex J; Armstrong, Elizabeth G

    2012-10-01

    To investigate whether a spaced-education (SE) game can be an effective means of teaching core content to medical students and a reliable and valid method of assessing their knowledge. This nine-month trial (2008-2009) enrolled students from three U.S. medical schools. The SE game consisted of 100 validated multiple-choice questions-explanations in preclinical/clinical domains. Students were e-mailed two questions daily. Adaptive game mechanics re-sent questions in three or six weeks if answered, respectively, incorrectly or correctly. Questions expired if not answered on time (appointment dynamic). Students retired questions by answering each correctly twice consecutively (progression dynamic). Posting of relative performance fostered competition. Main outcome measures were baseline and completion scores. Seven-hundred thirty-one students enrolled. Median baseline score was 53% (interquartile range [IQR] 16) and varied significantly by year (Pgames. An SE game is an effective and well-accepted means of teaching core content and a reliable and valid method to assess student knowledge. SE games may be valuable tools to identify and remediate students who could benefit from additional educational support.

  9. Can standardized diagnostic assessment be a useful adjunct to clinical assessment in child mental health services? A randomized controlled trial of disclosure of the Development and Well-Being Assessment to practitioners.

    Science.gov (United States)

    Ford, Tamsin; Last, Anna; Henley, William; Norman, Shelley; Guglani, Sacha; Kelesidi, Katerina; Martin, Anne-Marie; Moran, Pippa; Latham-Cork, Harriett; Goodman, Robert

    2013-04-01

    While research demands standardized diagnostic assessments as an indication of sufficient methodological rigour, there is debate about their application to clinical practice. The Development and Well-Being Assessment (DAWBA) provides a structured assessment of psychiatric disorder. Since it can be completed on-line, it could be used by Child and Adolescent Mental Health Services with few additional demands on staff. Access to the standardized diagnostic information as an adjunct to clinical assessment could reduce the number of appointments spent on assessment, free up practitioner time to work on engagement and improve clinical outcomes by increasing the accuracy of assessment and thus access to the appropriate evidence-based treatment. Randomized controlled trial of the disclosure of the DAWBA to the assessing practitioner (n = 117) versus assessment at normal (n = 118) and analysed by "intention to disclose". Exposure to the DAWBA may increase agreement between the DAWBA and practitioners about some anxiety disorders, but detected no other statistically significant increased agreement for other disorders, nor a reduced need for further assessment, the number of difficulties recognised or influence on outcomes. The results may be explained by the inadequacy of the DAWBA, lack of statistical power to detect any effects that were present or a reluctance of some practitioners to use the DAWBA in their assessment. Future research might benefit from exploring the use of the DAWBA or similar assessments as a referral rather than an assessment tool, and exploring how practitioners and parents experience and use the DAWBA and what training might optimise the utility of the DAWBA to clinical practice.

  10. Interlaboratory comparison of techniques for measuring lung burdens of low-energy X-ray emitters. Part of a coordinated programme on the calibration of burdens of inhaled plutonium by external counting

    International Nuclear Information System (INIS)

    Newton, D.; Fry, F.A.; Taylor, B.T.; Eagle, M.C.; Sharma, R.C.

    1978-02-01

    An interlaboratory exercise has been conducted to assess techniques of detection and calibration in the direct measurement of lung contamination with plutonium and other nuclides emitting only low-energy X-rays. Three volunteers, of small, intermediate and large physique, inhaled an aerosol incorporating Pd-103, a 20-keV X-ray emitter, and visited 13 other laboratories in the UK, Europe and North America. Participants in the exercise were asked to estimate each subject's lung content, using their procedures for assessing burdens of plutonium, and their estimates were compared with values derived independently from measurements of Cr-51, also incorporated in the inhaled particles, by gamma-ray spectrometry. Laboratories' calibration procedures were in most cases based on elaborate thorax phantoms, and these generally led to underestimates of the subjects' contents, in some instances by a factor of three or more; only one such laboratory produced estimates in satisfactory agreement with the independently-known values. The ''phoswich'' detectors, employed by most participants, appeared to be more sensitive than gas counters. If a standard configuration were required, offering the highest sensitivity in most situations, the choice would be a pair of 12-cm diameter phoswich detectors viewing the left and right anterior surfaces of the upper thorax. No improvement in sensitivity would result from increasing the size, although larger units may offer other advantages

  11. A blinded, randomized, controlled trial assessing conservative management strategies for frozen shoulder.

    Science.gov (United States)

    Russell, Sarah; Jariwala, Arpit; Conlon, Robert; Selfe, James; Richards, Jim; Walton, Michael

    2014-04-01

    There is little evidence for the optimal form of nonoperative treatment in the management of frozen shoulder. This study assesses the efficacy of current physiotherapy strategies. All primary care referrals of frozen shoulder to our physiotherapy department were included during a 12-month period. Of these referrals, 17% met the inclusion criteria for primary idiopathic frozen shoulder. The 75 patients were randomly assigned to 1 of 3 groups: group exercise class, individual physiotherapy, and home exercises alone. A single independent physiotherapist, who was blinded to the treatment groups, made all assessments. Range of motion, Constant score, Oxford Shoulder Score, Short Form 36, and Hospital Anxiety and Disability Scale (HADS) outcome measures were performed at baseline, 6 weeks, 6 months, and 1 year. The exercise class group improved from a mean Constant score of 39.8 at baseline to 71.4 at 6 weeks and 88.1 at 1 year. There was a significant improvement in shoulder symptoms on Oxford and Constant scores (P physiotherapy or home exercises alone (P physiotherapy groups over home exercises (P physiotherapy intervention groups than in home exercises alone. A hospital-based exercise class can produce a rapid recovery from a frozen shoulder with a minimum number of visits to the hospital and is more effective than individual physiotherapy or a home exercise program. Copyright © 2014 Journal of Shoulder and Elbow Surgery Board of Trustees. Published by Mosby, Inc. All rights reserved.

  12. A pilot study assessing social support among cancer patients enrolled on clinical trials: a comparison of younger versus older adults

    Directory of Open Access Journals (Sweden)

    Paul J Novotny

    2010-05-01

    Full Text Available Paul J Novotny1, Denise J Smith1, Lorna Guse2, Teresa A Rummans3, Lynn Hartmann4, Steven Alberts4, Richard Goldberg5, David Gregory6, Mary Johnson7, Jeff A Sloan11Health Sciences Research, Mayo Clinic, Rochester, MN, USA; 2Faculty of Nursing, University of Manitoba, Winnipeg, Manitoba, Canada; 3Psychiatry, Mayo Clinic, Rochester, MN, USA; 4Medical Oncology, Mayo Clinic, Rochester, MN, USA; 5Oncology Services, University of North Carolina, Chapel Hill, NC, USA; 6Faculty of Health Sciences Nursing, University of Lethbridge, Lethbridge, Alberta, Canada; 7Chaplain Services, Mayo Clinic, Rochester, MN, USAPurpose: This study tested the logistical feasibility of obtaining data on social support systems from cancer patients enrolled on clinical trials and compared the social support of older adults (age ≥65 and younger adults (<50 years of age with cancer.Methods: Patients had to be eligible for a phase II or phase III oncology clinical trial and enter the study prior to treatment. Patients filled out the Lubben Social Network Scale (LSNS at baseline. The Symptom Distress Scale (SDS and single-item overall quality of life (QOL Uniscale were assessed at baseline and weekly for 4 weeks.Results: There was no significant difference in overall mean Lubben social support levels by age. Older patients had more relatives they felt close to (85% versus 53% with 5 or more relatives, P = 0.02, heard from more friends monthly (84% versus 53% with 3 or more friends, P = 0.02, less overall symptom distress (P = 0.03, less insomnia (P = 0.003, better concentration (P = 0.005, better outlook (P = 0.01, and less depression (P = 0.005 than younger patients.Conclusions: Younger subjects reported worse symptoms, a smaller social support network, and fewer close friends and relatives than older subjects. Having someone to discuss decisions and seeing friends or relatives often was associated with longer survival. Keywords: social support, Lubben scale, QOL, elderly

  13. The MOVE study: a study protocol for a randomised controlled trial assessing interventions to maximise attendance at physical activity facilities.

    Science.gov (United States)

    Newton, Joshua D; Klein, Ruth; Bauman, Adrian; Newton, Fiona J; Mahal, Ajay; Gilbert, Kara; Piterman, Leon; Ewing, Michael T; Donovan, Robert J; Smith, Ben J

    2015-04-18

    Physical activity is associated with a host of health benefits, yet many individuals do not perform sufficient physical activity to realise these benefits. One approach to rectifying this situation is through modifying the built environment to make it more conducive to physical activity, such as by building walking tracks or recreational physical activity facilities. Often, however, modifications to the built environment are not connected to efforts aimed at encouraging their use. The purpose of the Monitoring and Observing the Value of Exercise (MOVE) study is to evaluate the effectiveness of two interventions designed to encourage the ongoing use of a new, multi-purpose, community-based physical activity facility. A two-year, randomised controlled trial with yearly survey points (baseline, 12 months follow-up, 24 months follow-up) will be conducted among 1,300 physically inactive adult participants aged 18-70 years. Participants will be randomly assigned to one of three groups: control, intervention 1 (attendance incentives), or intervention 2 (attendance incentives and tailored support following a model based on customer relationship management). Primary outcome measures will include facility usage, physical activity participation, mental and physical wellbeing, community connectedness, social capital, friendship, and social support. Secondary outcome measures will include stages of change for facility usage and social cognitive decision-making variables. This study will assess whether customer relationship management systems, a tool commonly used in commercial marketing settings, can encourage the ongoing use of a physical activity facility. Findings may also indicate the population segments among which the use of such systems are most effective, as well as their cost-effectiveness. Australian New Zealand Clinical Trials Registry: ACTRN12615000012572 (registered 9 January 2015).

  14. Prospective randomized trial to assess effects of continuing hormone therapy on cerebral function in postmenopausal women at risk for dementia.

    Directory of Open Access Journals (Sweden)

    Natalie L Rasgon

    Full Text Available The objective of this study was to examine the effects of estrogen-based hormone therapy (HT on regional cerebral metabolism in postmenopausal women (mean age = 58, SD = 5 at risk for development of dementia. The prospective clinical trial design included pre- and post-intervention neuroimaging of women randomized to continue (HT+ or discontinue (HT- therapy following an average of 10 years of use. The primary outcome measure was change in brain metabolism during the subsequent two years, as assessed with fluorodeoxyglucose-18 positron emission tomography (FDG-PET. Longitudinal FDG-PET data were available for 45 study completers. Results showed that women randomized to continue HT experienced relative preservation of frontal and parietal cortical metabolism, compared with women randomized to discontinue HT. Women who discontinued 17-β estradiol (17βE-based HT, as well as women who continued conjugated equine estrogen (CEE-based HT, exhibited significant decline in metabolism of the precuneus/posterior cingulate cortical (PCC area. Significant decline in PCC metabolism was additionally seen in women taking concurrent progestins (with either 17βE or CEE. Together, these findings suggest that among postmenopausal subjects at risk for developing dementia, regional cerebral cortical metabolism is relatively preserved for at least two years in women randomized to continue HT, compared with women randomized to discontinue HT. In addition, continuing unopposed 17βE therapy is associated specifically with preservation of metabolism in PCC, known to undergo the most significant decline in the earliest stages of Alzheimer's disease.ClinicalTrials.gov NCT00097058.

  15. Disagreements between central clinical events committee and site investigator assessments of myocardial infarction endpoints in an international clinical trial: review of the PURSUIT study

    Directory of Open Access Journals (Sweden)

    Lee Kerry L

    2001-07-01

    Full Text Available Abstract Background Limited information has been published regarding how specific processes for event adjudication can affect event rates in trials. We reviewed nonfatal myocardial infarctions (MIs reported by site investigators in the international Platelet Glycoprotein IIb/IIIa in Unstable Angina: Receptor Suppression Using Integrilin (Eptifibatide Therapy (PURSUIT trial and those adjudicated by a central clinical events committee (CEC to determine the reasons for differences in event rates. Methods The PURSUIT trial randomised 10,948 patients with acute coronary syndromes to receive eptifibatide or placebo. The primary end-point was death or post-enrolment MI at 30 days as assessed by the CEC; this end-point was also constructed using site-reported events. The CEC identified suspected MIs by systematic review of clinical, cardiac enzyme, and electrocardiographic data. Results The CEC identified 5005 (46% suspected events, of which 1415 (28% were adjudicated as MI. The site investigator and CEC assessments of whether a MI had occurred disagreed in 983 (20% of the 5005 patients with suspected MI, mostly reflecting site misclassification of post-enrolment MIs (as enrolment MIs or underreported periprocedural MIs. Patients for whom the CEC and site investigator agreed that no end-point MI had occurred had the lowest mortality at 30 days and between 30 days and 6 months, and those with agreement that a MI had occurred had the highest mortality. Conclusion CEC adjudication provides a standard, systematic, independent, and unbiased assessment of end-points, particularly for trials that span geographic regions and clinical practice settings. Understanding the review process and reasons for disagreement between CEC and site investigator assessments of MI is important to design future trials and interpret event rates between trials.

  16. A one-year trial to assess the value of orlistat in the management of obesity.

    Science.gov (United States)

    James, W P; Avenell, A; Broom, J; Whitehead, J

    1997-06-01

    This paper describes the methodology of a multicentre study designed to assess the efficacy and tolerability of orlistat 120 mg tid as therapy for inducing weight loss in excess of that achieved with a moderately calorie-restricted diet alone. The results from a single centre are presented to illustrate the nature of the response. This was a double-blind, randomized, parallel-group, placebo-controlled multicentre study. A four-week, single-blind, placebo run-in period preceded a 52 week double-blind treatment period during which patients received either orlistat or placebo three times a day. At the start of the run-in period, all patients were placed on a diet containing approximately 30% of calories as fat and designed to cause an energy deficit of approximately 600 kcal/d. Patients of either sex, more than 18 y of age, with a body mass index (BMI) between 30 and 43 kg/m2 were eligible for enrolment. Efficacy assessments included: measurements of body weight; anthropometry; quality of life; blood pressure; serum lipids; fasting serum glucose and insulin. Safety assessments included: adverse events; vital signs; ECG; renal and gallbladder ultrasound; haematology; serum biochemistry. In the single centre there was a reduction in body weight of 5.5 +/- 4.5 (s.d.) kg (5.7% reduction) in the placebo group and 8.6 +/- 5.4kg in the orlistat-treated group (8.4% reduction) by six months. Thereafter, the placebo group tended to relapse whereas the orlistat group maintained their loss (2.6% vs 8.4% reduction from initial value at 52 weeks). Total and LDL cholesterol fell by 0.05 mmol/l (1.6%) and 0.14 mmol/l (4.2%), respectively, in orlistat treated patients. The drop-out rate was 48% in the placebo group and 39% in the orlistat group. Intestinal symptoms related to orlistat were significantly increased compared to placebo but were well tolerated. Fat soluble vitamin levels remained within the normal range in the treatment group; the reduction seen in alpha-tocopherol levels

  17. Exploring a New Simulation Approach to Improve Clinical Reasoning Teaching and Assessment: Randomized Trial Protocol.

    Science.gov (United States)

    Pennaforte, Thomas; Moussa, Ahmed; Loye, Nathalie; Charlin, Bernard; Audétat, Marie-Claude

    2016-02-17

    Helping trainees develop appropriate clinical reasoning abilities is a challenging goal in an environment where clinical situations are marked by high levels of complexity and unpredictability. The benefit of simulation-based education to assess clinical reasoning skills has rarely been reported. More specifically, it is unclear if clinical reasoning is better acquired if the instructor's input occurs entirely after or is integrated during the scenario. Based on educational principles of the dual-process theory of clinical reasoning, a new simulation approach called simulation with iterative discussions (SID) is introduced. The instructor interrupts the flow of the scenario at three key moments of the reasoning process (data gathering, integration, and confirmation). After each stop, the scenario is continued where it was interrupted. Finally, a brief general debriefing ends the session. System-1 process of clinical reasoning is assessed by verbalization during management of the case, and System-2 during the iterative discussions without providing feedback. The aim of this study is to evaluate the effectiveness of Simulation with Iterative Discussions versus the classical approach of simulation in developing reasoning skills of General Pediatrics and Neonatal-Perinatal Medicine residents. This will be a prospective exploratory, randomized study conducted at Sainte-Justine hospital in Montreal, Qc, between January and March 2016. All post-graduate year (PGY) 1 to 6 residents will be invited to complete one SID or classical simulation 30 minutes audio video-recorded complex high-fidelity simulations covering a similar neonatology topic. Pre- and post-simulation questionnaires will be completed and a semistructured interview will be conducted after each simulation. Data analyses will use SPSS and NVivo softwares. This study is in its preliminary stages and the results are expected to be made available by April, 2016. This will be the first study to explore a new

  18. Trial application of the candidate root cause categorization scheme and preliminary assessment of selected data bases for the root causes of component failures program

    International Nuclear Information System (INIS)

    Bruske, S.Z.; Cadwallader, L.C.; Stepina, P.L.

    1985-04-01

    The objective of the Nuclear Regulatory Commission's (NRC) Root Causes of Component Failures Program is to develop and apply a categorization scheme for identifying root causes of failures for components that comprise safety and safety support systems of nuclear power plants. Results from this program will provide valuable input in the areas of probabilistic risk assessment, reliability assurance, and application of risk assessments in the inspection program. This report presents the trial application and assessment of the candidate root cause categorization scheme to three failure data bases: the In-Plant Reliability Data System (IPRDS), the Licensee Event Report (LER) data base, and the Nuclear Plant Reliability Data System (NPRDS). Results of the trial application/assessment show that significant root cause information can be obtained from these failure data bases

  19. ParaMED Home: A protocol for a randomised controlled trial of paramedic assessment and referral to access medical care at home

    Directory of Open Access Journals (Sweden)

    Johnston Steven

    2011-06-01

    Full Text Available Abstract Background In Australia approximately 25% of Emergency Department (ED attendances are via ambulance. ED overcrowding in Australia, as in many countries, is common. Measures to reduce overcrowding include the provision of enhanced timely primary care in the community for appropriate low risk injury and illness. Therefore paramedic assessment and referral to a community home hospital service, in preference to transfer to ED, may confer clinical and cost benefit. Methods/Design A randomised controlled trial. Consenting adult patients that call an ambulance and are assessed by paramedics as having an eligible low risk problem will be randomised to referral to ED via ambulance transfer or referral to a rapid response service that will assess and treat the patient in their own residence. The primary outcome measure is requirement for unplanned medical attention (in or out of hospital in the first 48 hours. Secondary outcomes will include a number of other clinical endpoints. A cost effectiveness analysis will be conducted. Discussion If this trial demonstrates clinical non-inferiority and cost savings associated with the primary assessment service, it will provide one means to safely address ED overcrowding. Trial Registration Australian and New Zealand Clinical Trials Registry Number 12610001064099

  20. Assessing the Consequences of Microbial Infection in Field Trials: Seen, Unseen, Beneficial, Parasitic and Pathogenic

    Directory of Open Access Journals (Sweden)

    Mark E. Looseley

    2014-06-01

    Full Text Available Microbial infections of crop plants present an ongoing threat to agricultural production. However, in recent years, we have developed a more nuanced understanding of the ecological role of microbes and how they interact with plants. This includes an appreciation of the influence of crop physiology and environmental conditions on the expression of disease symptoms, the importance of non-pathogenic microbes on host plants and pathogens, and the capacity for plants to act as hosts for human pathogens. Alongside this we now have a variety of tools available for the identification and quantification of microbial infections on crops grown under field conditions. This review summarises some of the consequences of microbial infections in crop plants, and discusses how new and established assessment tools can be used to understand these processes. It challenges our current assumptions in yield loss relationships and offers understanding of the potential for more resilient crops.

  1. Impossibility to eliminate observer effect in the assessment of adherence in clinical trials.

    Science.gov (United States)

    Myers, Jonathan S; Fudemberg, Scott J; Fintelmann, Robert E; Hark, Lisa A; Khanna, Nitasha; Leiby, Benjamin E; Waisbourd, Michael

    2016-01-01

    To utilize the Travoprost Dosing Aid (DA) in the assessment of patient medication adherence, while also determining whether or not altering the functionality of the DA in three randomized subject groups can reduce observer effect. Forty-five subjects were randomized into three groups: two with monitored DAs and one without monitoring. One group of subjects was given a DA that both monitored drop usage and had visual and audible alarms, while the other monitored group included subjects given a DA that had no alarms but continued to monitor drop usage. The third group was given a DA that had no alarm reminders or dose usage monitoring. Subjects were informed that some monitors would not be functional, in an attempt to reduce observer effect, or the effect of being monitored on subject behavior and adherence. A six-item questionnaire was also utilized to assess how the subjects felt about their adherence and DA use. The overall adherence rates were found to be 78% in the fully functional group (95% confidence interval: 70-88) and 76% in the no alarms group (95% confidence interval: 65-89). No association was seen between questionnaire response and medication adherence. The patients in the DA group without alarms had a significantly higher odds ratio of medication adherence if they reported on the questionnaire that using the DA did affect how much they used their drops. Though the use of DA was expected to reveal different rates of adherence depending on the functionality of the DA between groups, patients with a nonfunctioning DA did not have a significant difference in medication adherence compared to those given a fully functional DA. This supports that an observer effect was not reduced despite these interventions, and that the subjects adhered to taking their medications as if they had a functioning DA and were being monitored.

  2. Serial volumetric assessment of coronary fibroatheroma by optical frequency domain imaging: insights from the TROFI trial.

    Science.gov (United States)

    Campos, Carlos M; Garcia-Garcia, Hector M; Iqbal, Javaid; Muramatsu, Takashi; Nakatani, Shimpei; Dijkstra, Jouke; Onuma, Yoshinobu; Serruys, Patrick W

    2018-01-01

    Coronary lesions precursors of acute events remain elusive, since they undergo continuous changes and their temporal changes are not very well-characterized. In natural history studies, optical frequency domain imaging (OFDI) has been used only to assess fibroatheromas as a 2D structure and sometimes in a single frame fashion. We aim at describing the serial volumetric modifications of the fibrous cap (FC) of the fibroatheromas as determined by OFDI over a 6-month follow-up period. In 49 patients, OFDI investigation was performed following treatment of culprit lesion and at 6-month follow-up in patients with ST-segment elevation myocardial infarction (STEMI). A fully automatic volumetric quantification of FC was done in all lipid-containing frames of non-culprit lesions in the infarct related artery. These lesions were matched at baseline and 6-month follow-up. A total of 58 non-culprit lipid rich lesions (34 TCFAs and 24 thick-cap fibroatheroma [ThCFA]) were found in 34 patients at baseline. Overall, there was a FC volume decrease of 1.57 (Inter-quartile Range [IQR] -4.13 to 0.54) mm3 at 6-months. 27% of the lesions changed their phenotype over time (TCFA or ThCFA). TCFAs that became ThCFAs at follow-up had smaller mean and maximal FC as compared with lesions that remained TCFAs (P = 0.01 for both). Non-culprit fibroatheromas located in the infarct related artery of patients with STEMI had a volumetric reduction of the FC after 6-month follow-up. Quantitative FC assessment was able to differentiate high-risk lesions that became ThCFAs. There was a considerable change of plaque phenotype (TCFAs or ThCFAs) over time.

  3. A methodological framework for assessing agreement between cost-effectiveness outcomes estimated using alternative sources of data on treatment costs and effects for trial-based economic evaluations.

    Science.gov (United States)

    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.

  4. Early multidisciplinary assessment was associated with longer periods of sick leave: A randomized controlled trial in a primary health care centre

    OpenAIRE

    Carlsson, Lars; Englund, Lars; Hallqvist, Johan; Wallman, Thorne

    2013-01-01

    Abstract Objective To study the effects on sick leave from an early multidisciplinary assessment at a primary health care centre. Design Randomized controlled trial. Setting Patients who saw GPs at a primary health care centre in mid-Sweden and asked for a sickness certificate for psychiatric or musculoskeletal diagnoses were invited to participate. Patients included were sick-listed for less than four weeks; 33 patients were randomized either to an assessment within a week by a physiotherapi...

  5. A Randomized Controlled Trial to Assess the Effects of Competition on the Development of Laparoscopic Surgical Skills.

    Science.gov (United States)

    Hashimoto, Daniel A; Gomez, Ernest D; Beyer-Berjot, Laura; Khajuria, Ankur; Williams, Noel N; Darzi, Ara; Aggarwal, Rajesh

    2015-01-01

    Serious games have demonstrated efficacy in improving participation in surgical training activities, but studies have not yet demonstrated the effect of serious gaming on performance. This study investigated whether competitive training (CT) affects laparoscopic surgical performance. A total of 20 novices were recruited, and 18 (2 dropouts) were randomized into control or CT groups to perform 10 virtual reality laparoscopic cholecystectomies (LCs). Competitiveness of each participant was assessed. The CT group members were informed they were competing to outperform one another for a prize; performance ranking was shown before each session. The control group did not compete. Performance was assessed on time, movements, and instrument path length. Quality of performance was assessed with a global rating scale score. There were no significant intergroup differences in baseline skill or measured competitiveness. Time and global rating scale score, at final LC, were not significantly different between groups; however, the CT group was significantly more dexterous than control and had significantly lower variance in number of movements and instrument path length at the final LC (p = 0.019). Contentiousness was inversely related to time in the CT group. This was the first randomized controlled trial to investigate if CT can enhance performance in laparoscopic surgery. CT may lead to improved dexterity in laparoscopic surgery but yields otherwise similar performance to that of standard training in novices. Competition may have different effects on novices vs experienced surgeons, and subsequent research should investigate CT in experienced surgeons as well. Copyright © 2015 Association of Program Directors in Surgery. Published by Elsevier Inc. All rights reserved.

  6. Dry weight assessment by combined ultrasound and bioimpedance monitoring in low cardiovascular risk hemodialysis patients: a randomized controlled trial.

    Science.gov (United States)

    Siriopol, Dimitrie; Onofriescu, Mihai; Voroneanu, Luminita; Apetrii, Mugurel; Nistor, Ionut; Hogas, Simona; Kanbay, Mehmet; Sascau, Radu; Scripcariu, Dragos; Covic, Adrian

    2017-01-01

    Fluid overload is associated with adverse outcomes in hemodialysis (HD) patients. The precise assessment of hydration status in HD patients remains a major challenge for nephrologists. Our study aimed to explore whether combining two bedside methods, lung ultrasonography (LUS) and bioimpedance, may provide complementary information to guide treatment in specific HD patients. In total, 250 HD patients from two dialysis units were included in this randomized clinical trial. Patients were randomized 1:1 to have a dry weight assessment based on clinical (control) or LUS with bioimpedance in case of clinical hypovolemia (active)-guided protocol. The primary outcome was to assess the difference between the two groups on a composite of all-cause mortality and first cardiovascular event (CVE)-including death, stroke, and myocardial infarction. During a mean follow-up period was 21.3 ± 5.6 months, there were 54 (21.6%) composite events in the entire population. There was a nonsignificant 9% increase in the risk of this outcome in the active arm (HR = 1.09, 95% CI 0.64-1.86, p = 0.75). Similarly, there were no differences between the two groups when analyzing separately the all-cause mortality and CVE outcomes. However, patients in the active arm had a 19% lower relative risk of pre-dialytic dyspnea (rate ratio-0.81, 95% CI 0.68-0.96), but a 26% higher relative risk of intradialytic cramps (rate ratio-1.26, 95% CI 1.16-1.37). This study shows that a LUS-bioimpedance-guided dry weight adjustment protocol, as compared to clinical evaluation, does not reduce all-cause mortality and/or CVE in HD patients. A fluid management protocol based on bioimpedance with LUS on indication might be a better strategy.

  7. Measurement of the translation and impact from a childhood obesity trial programme: rationale and protocol for a research impact assessment.

    Science.gov (United States)

    Reeves, Penny; Deeming, Simon; Ramanathan, Shanthi; Wiggers, John; Wolfenden, Luke; Searles, Andrew

    2017-12-19

    There is growing recognition amongst health and medical research funders and researchers that translation of research into policy and practice needs to increase and that more transparency is needed on how impacts are realised. Several approaches are advocated for achieving this, including co-production of research or academic-practitioner research. The Population Health Unit (PHU) within the Hunter New England Local Health District in regional Australia, as an early adopter of this model, has been working to increase the likelihood that its research is translated into community health benefits. With the New South Wales Ministry of Health, the PHU responded to the burden of child overweight and obesity by combining service delivery with research expertise. The 'Good for Kids, Good for Life' (Good for Kids) dissemination trial was developed and implemented in seven community settings in the Hunter region of Australia between 2006 and 2010. This study aims to undertake a retrospective impact assessment to measure the research translation and impact of Good for Kids. The method will be based upon the application of the Framework to Assess the Impact from Translational health research (FAIT), comprising three core elements, namely quantified metrics, economic assessment and a narrative of the process by which the research in question translates and generates impact. Increasingly, funders are interested both in the outcomes resulting from investments in health research and in the expected return on their investments. FAIT was developed specifically for this purpose and its use is anticipated to provide transparency to the pathway to translation and potentially drive increased investment in translational research programmes such as Good for Kids.

  8. Protocol of a randomized cluster trial to assess the effectiveness of the MOVI-2 program on overweight prevention in schoolchildren.

    Science.gov (United States)

    Martínez-Vizcaíno, Vicente; Sánchez-López, Mairena; Salcedo-Aguilar, Fernando; Notario-Pacheco, Blanca; Solera-Martínez, Montserrat; Moya-Martínez, Pablo; Franquelo-Morales, Pablo; López-Martínez, Sara; Rodríguez-Artalejo, Fernando

    2012-05-01

    The MOVI physical activity program has been shown to reduce adiposity and to improve serum lipid profiles in schoolchildren. However, MOVI may have not achieved its maximum potential effectiveness, as increased physical activity on weekdays may have been offset by more sedentary behavior at weekends. We therefore developed the MOVI-2 program, which includes physical activity at weekends as well. This paper reports the rationale and methods of a trial to assess the effectiveness of MOVI-2 in preventing overweight and reducing cardiovascular risk in 1200 4th- and 5th-grade primary schoolchildren in Cuenca, Spain. Ten schools were randomly assigned to MOVI-2 and 10 schools to the control group. MOVI-2 consisted of recreational physical activity in after-school time, including two 90-min sessions on weekdays and one 150-min session on Saturdays, during each week of one academic year. The control group was expected to follow their usual patterns of physical activity. The primary end points, which were assessed at the start and the end of the MOVI-2 program, were weight and height, waist circumference, skinfold thickness, body fat percentage, blood pressure, lipid profile, and insulin resistance. Secondary end points were physical activity, fitness, health-related quality of life, sleep quality, academic performance, enjoyment with physical activity, and physical self-concept. This study will assess whether MOVI-2 overcomes some potential limitations of physical activity interventions in children (Clinicaltrials.gov number NCT01277224). Copyright © 2011 Sociedad Española de Cardiología. Published by Elsevier Espana. All rights reserved.

  9. Assessment of the Safety and Immunogenicity of 2 Novel Vaccine Platforms for HIV-1 Prevention: A Randomized Trial

    Science.gov (United States)

    Baden, Lindsey R; Karita, Etienne; Mutua, Gaudensia; Bekker, Linda-Gail; Gray, Glenda; Page-Shipp, Liesl; Walsh, Stephen R; Nyombayire, Julien; Anzala, Omu; Roux, Surita; Laher, Fatima; Innes, Craig; Seaman, Michael; Cohen, Yehuda Z; Peter, Lauren; Frahm, Nicole; McElrath, M Juliana; Hayes, Peter; Swann, Edith; Grunenberg, Nicole; Grazia-Pau, Maria; Weijtens, Mo; Sadoff, Jerry; Dally, Len; Lombardo, Angela; Gilmour, Jill; Cox, Josephine; Dolin, Raphael; Fast, Patricia; Barouch, Dan H; Laufer, Dagna S; Johnson, Jennifer; Kleinjan, Jane; Ingabire, Rosine; Nyasani, Delvin; Crida, Danielle; Mangeya, Nicholas; Mamba, Musawenkosi; Mngadi, Kathy; Dominguez, David J; Yanosick, Katherine E; Cormier, Emmanuel; Hural, John; Stevens, Gwynn; Adams, Elizabeth; Kublin, James; Hendriks, Jenny; Sayeed, Eddy; Ackland, James; Anas, Kamaal; Zackariah, Devika; Vooijs, Dani; Chinyenze, Kundai; Matsoso, Mabela; Park, Harriet; Welsh, Sabrina

    2016-01-01

    Background A prophylactic HIV-1 vaccine is a global health priority. Objective To assess a novel vaccine platform as a prophylactic HIV-1 vaccine regimen. Design/Setting This randomized, double-blind, placebo-controlled trial assessed two candidate HIV-1 vaccines (Ad26.EnvA and Ad35-Env both at 5×1010 vp) in homologous and heterologous combinations in three geographic regions (US, East and South Africa). Both subjects and study personnel were blinded to treatment allocation. (NCT 01215149). Patients Healthy HIV uninfected adults. Measurements Safety and immunogenicity were assessed and the impact of baseline vector immunity was analyzed. Results 217 subjects received at least 1 vaccination and 210 (>96%) completed follow-up, No vaccine-associated serious adverse events occurred. All regimens were generally well tolerated though more vaccine recipients had transient moderate or severe systemic reactions (36.5%) compared to placebo recipients (20.5%). All regimens elicited humoral and cellular immune responses in nearly all volunteers. There was no impact of pre-existing Ad26 or Ad35 neutralizing antibody titers on vaccine safety and little on immunogenicity. In both homologous and heterologous regimens the second vaccination significantly increased EnvA antibody titers (~20 fold from median ELISA titers of 30–300 to 3000). The heterologous regimen Ad26-Ad35 elicited significantly higher EnvA antibody titers than Ad35-Ad26. T cell responses were modest and lower in East Africa than in South Africa and the United States. Conclusions Both vaccines elicited significant immune responses in all populations. Baseline vector immunity did not have a significant impact on immune responses. Second vaccinations in all regimens significantly boosted EnvA titers though vaccine order in the heterologous regimen had a modest effect on the immune response. Primary Funding IAVI, NIAID/NIH, and the Ragon Institute in collaboration with Crucell Holland BV. PMID:26833336

  10. The PD COMM trial: a protocol for the process evaluation of a randomised trial assessing the effectiveness of two types of SLT for people with Parkinson's disease.

    Science.gov (United States)

    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.

  11. Impossibility to eliminate observer effect in the assessment of adherence in clinical trials

    Directory of Open Access Journals (Sweden)

    Myers JS

    2016-10-01

    Full Text Available Jonathan S Myers,1 Scott J Fudemberg,1 Robert E Fintelmann,2 Lisa A Hark,1 Nitasha Khanna,1 Benjamin E Leiby,3 Michael Waisbourd1 1Wills Eye Hospital, Glaucoma Research Center, Philadelphia, PA, 2Barnet Dulaney Perkins Eye Center, Phoenix, AZ, 3Division of Biostatistics, Thomas Jefferson University, Philadelphia, PA, USA Purpose: To utilize the Travoprost Dosing Aid (DA in the assessment of patient medication adherence, while also determining whether or not altering the functionality of the DA in three randomized subject groups can reduce observer effect. Methods: Forty-five subjects were randomized into three groups: two with monitored DAs and one without monitoring. One group of subjects was given a DA that both monitored drop usage and had visual and audible alarms, while the other monitored group included subjects given a DA that had no alarms but continued to monitor drop usage. The third group was given a DA that had no alarm reminders or dose usage monitoring. Subjects were informed that some monitors would not be functional, in an attempt to reduce observer effect, or the effect of being monitored on subject behavior and adherence. A six-item questionnaire was also utilized to assess how the subjects felt about their adherence and DA use. Results: The overall adherence rates were found to be 78% in the fully functional group (95% confidence interval: 70–88 and 76% in the no alarms group (95% confidence interval: 65–89. No association was seen between questionnaire response and medication adherence. The patients in the DA group without alarms had a significantly higher odds ratio of medication adherence if they reported on the questionnaire that using the DA did affect how much they used their drops. Conclusion: Though the use of DA was expected to reveal different rates of adherence depending on the functionality of the DA between groups, patients with a nonfunctioning DA did not have a significant difference in medication adherence

  12. Electronic assessment of peri-implant mucosal esthetics around three implant-abutment configurations: a randomized clinical trial.

    Science.gov (United States)

    Barwacz, Christopher A; Stanford, Clark M; Diehl, Ursula A; Qian, Fang; Cooper, Lyndon F; Feine, Jocelyne; McGuire, Michael

    2016-06-01

    To objectively assess the influence that three different implant-abutment interface designs had on peri-implant mucosal esthetics at 1 year post-implant placement via the pink esthetic score (PES). Additionally, to demonstrate the novel employment of a tablet-based digital imaging format to reliably assess and score clinical images as part of a multicenter clinical trial according to PES criteria. Adult subjects (n = 141) with healed tooth-bound edentulous sites in the anterior maxilla as well as first premolar region were randomized to receive one of three different implant-abutment interface designs (conical interface = CI; flat-to-flat interface = FI; or platform switch interface = PS). Immediate provisionalization was performed with prefabricated titanium abutments, with definitive custom CAD/CAM zirconia abutments and all-ceramic cement-based crowns being delivered 12-week post-implant placement. Bilateral (anterior sites) or unilateral (premolar sites) digital clinical photographs were made at 1, 3, 6, and 12 months post-implant placement. Five calibrated faculty evaluators of different clinical backgrounds scored images during a 4-week timeframe on a standardized, tablet-based, digital imaging format. Six hundred and forty-nine clinical photographs were evaluated resulting in a total of 3245 sum PES values and 22,715 individual PES values. Faculty evaluator intra- and inter-rater reliability was found to be "strong" (ICC = 0.84) and "substantial" (ICC = 0.64), respectively, demonstrating repeatability of both the PES, evaluator calibration, and standardization of tablet-based scoring. All implant-abutment interface groups demonstrated significant improvements in mean sum PESs up to 1 year, with the largest improvement between restoration delivery and 6 months. No significant differences were found between groups in mean sum PESs both for individual study visits as well as for changes between study visits. No significant differences in mean

  13. Assessing the effects of interventions for Aedes aegypti control: systematic review and meta-analysis of cluster randomised controlled trials

    Directory of Open Access Journals (Sweden)

    Víctor Alvarado-Castro

    2017-05-01

    Full Text Available Abstract Background The Aedes aegypti mosquito is the vector for dengue fever, yellow fever, chikungunya, and zika viruses. Inadequate vector control has contributed to persistence and increase of these diseases. This review assesses the evidence of effectiveness of different control measures in reducing Aedes aegypti proliferation, using standard entomological indices. Methods A systematic search of Medline, Ovid, BVS, LILACS, ARTEMISA, IMBIOMED and MEDIGRAPHIC databases identified cluster randomised controlled trials (CRCTs of interventions to control Aedes aegypti published between January 2003 and October 2016. Eligible studies were CRCTs of chemical or biological control measures, or community mobilization, with entomological indices as an endpoint. A meta-analysis of eligible studies, using a random effects model, assessed the impact on household index (HI, container index (CI, and Breteau index (BI. Results From 848 papers identified by the search, eighteen met the inclusion criteria: eight for chemical control, one for biological control and nine for community mobilisation. Seven of the nine CRCTs of community mobilisation reported significantly lower entomological indices in intervention than control clusters; findings from the eight CRCTs of chemical control were more mixed. The CRCT of biological control reported a significant impact on the pupae per person index only. Ten papers provided enough detail for meta-analysis. Community mobilisation (four studies was consistently effective, with an overall intervention effectiveness estimate of −0.10 (95%CI -0.20 – 0.00 for HI, −0.03 (95%CI -0.05 – -0.01 for CI, and −0.13 (95%CI -0.22 – -0.05 for BI. The single CRCT of biological control had effectiveness of −0.02 (95%CI -0.07– 0.03 for HI, −0.02 (95%CI -0.04– -0.01 for CI and −0.08 (95%CI -0.15– -0.01 for BI. The five studies of chemical control did not show a significant impact on indices: the overall effectiveness

  14. A randomized controlled trial to assess the efficacy of an interactive mobile messaging intervention for underserved smokers: Project ACTION

    Directory of Open Access Journals (Sweden)

    Vidrine Damon J

    2012-08-01

    Full Text Available Abstract Background Despite a significant decrease in smoking prevalence over the past ten years, cigarette smoking still represents the leading cause of preventable morbidity and mortality in the United States. Moreover, smoking prevalence is significantly higher among those with low levels of education and those living at, or below, the poverty level. These groups tend to be confronted with significant barriers to utilizing more traditional smoking cessation intervention approaches. The purpose of the study, Project ACTION (Adult smoking Cessation Treatment through Innovative Outreach to Neighborhoods, is to utilize a mobile clinic model, a network of community sites (i.e., community centers and churches and an interactive mobile messaging system to reach and deliver smoking cessation treatment to underserved, low-income communities. Methods/Design We are using a group-randomized design, with the community site as the sampling unit, to compare the efficacy of three smoking cessation interventions: 1 Standard Care - brief advice to quit smoking, nicotine replacement therapy (NRT, and self-help materials; 2 Enhanced Care - standard care components plus a cell phone-delivered text/graphical messaging component; and 3 Intensive Care - enhanced care components plus a series of 11 cell phone-delivered proactive counseling sessions. An economic evaluation will also be performed to evaluate the relative cost effectiveness of the three treatment approaches. We will recruit 756 participants (252 participants in each of the 3 intervention groups. At the time of randomization, participants complete a baseline assessment, consisting of smoking history, socio-demographic, and psychosocial variables. Monthly cell phone assessments are conducted for 6 months-post enrollment, and a final 12-month follow-up is conducted at the original neighborhood site of enrollment. We will perform mixed-model logistic regression to compare the efficacy of the three smoking

  15. PROSPECTIVE RANDOMIZED TRIAL ASSESSING THE IMPACT OF FEEDBACK MECHANISMS ON PATIENT POSITIONING.

    Science.gov (United States)

    Dimopoulos, Spyridon; Vivell, Julian; Ziemssen, Focke; Bende, Thomas; Bartz-Schmidt, Karl Ulrich; Leitritz, Martin Alexander

    2017-12-20

    To investigate the use of a head-fixed feedback sensor to improve good positioning times after macular hole or retinal detachment surgery. The instructional methods, macular hole closure rates, and questionnaire responses were also evaluated. After randomization, sensor devices with different feedback types (none/acoustic/vibration) were fixed on the patients' heads. Two positioning recommendations (verbal/illustrated) were used. The posturing data were logged every 500 ms for 24 hours. Forty-eight data sets (24 per group) were evaluated. Using sensory feedback, the median time for face-down positioning after macular hole surgery (Group 1) was significantly boosted from 463 minutes (range: 61-1,168) to 1,257 minutes (range: 1,024-1,327). The side positioning time after retinal detachment surgery (Group 2) increased from a median of 1,032 minutes (range: 520-1,165) to 1,284 minutes (range: 1,231-1,437). The night-time alarm records were reduced; however, the instructional methods exhibited no noteworthy effects. The questionnaires indicated positive acceptance of the sensors. Sensory feedback may help in cases where face-down or side positioning is recommended. These constant reminders were superior to verbal or written reminders; however, further studies are required to assess the clinical impact of sensory feedback on patient positioning.

  16. Performance assessment of diffuse optical spectroscopic imaging instruments in a 2-year multicenter breast cancer trial

    Science.gov (United States)

    Leproux, Anaïs; O'Sullivan, Thomas D.; Cerussi, Albert; Durkin, Amanda; Hill, Brian; Hylton, Nola; Yodh, Arjun G.; Carp, Stefan A.; Boas, David; Jiang, Shudong; Paulsen, Keith D.; Pogue, Brian; Roblyer, Darren; Yang, Wei;