[It is not only about cost ... when it comes to generic medication].

PubMed

Piguet, Valérie; D'Incau, Stéphanie; Besson, Marie; Desmeules, Jules; Cedraschi, Christine

2016-06-22

The aim of this qualitative study was to explore patients' representations regarding generics in patients suffering from non-specific disabling chronic musculoskeletal pain, as these patients are confronted with the issue of the prescription and/or substitution of original formulations with generics. Patients' representations suggest that they might be confident in taking a generic medication: when the generic medication is prescribed by the physician and each prescription is discussed, i.e., the patient is prescribed the generic version of a given medication and not a generic medication. Economic arguments are not sufficient to accept substitution. Negative representations require attention and need be considered.

Effect of generic drug competition on the price of prescription drugs in Ontario.

PubMed Central

Lexchin, J

1993-01-01

OBJECTIVE: To analyse the potential effect of generic drug competition on prices in Ontario to assess the costs and benefits associated with Bill C-22 (An Act to amend the Patent Act). DESIGN: Comparison of the cost of the least and most expensive versions of all products sold by more than one manufacturer in 1991. The number of brand-name and generic drug companies marketing each of the products was recorded. RESULTS: Of 1599 products 437 (27.3%) were made by more than one company. Almost half (44.6%) of the 437 were sold by two companies. The more companies that sold a drug the greater the difference in price between the least and most expensive versions. Similarly, as the proportion of generic drug companies in competition increased, the greater the price difference. When competition was between generic drug companies only, the price spread was smaller than when it was between brand-name drug companies only. CONCLUSIONS: Generic drug competition can result in savings to the Ontario Drug Benefit Plan. A more in-depth analysis of the potential savings is necessary to fully assess the costs and benefits associated with Bill C-22. PMID:8439888

Physicians' Trust in the FDA's Use of Product-Specific Pathways for Generic Drug Approval.

PubMed

Kesselheim, Aaron S; Eddings, Wesley; Raj, Tara; Campbell, Eric G; Franklin, Jessica M; Ross, Kathryn M; Fulchino, Lisa A; Avorn, Jerry; Gagne, Joshua J

2016-01-01

Generic drugs are cost-effective versions of brand-name drugs approved by the Food and Drug Administration (FDA) following proof of pharmaceutical equivalence and bioequivalence. Generic drugs are widely prescribed by physicians, although there is disagreement over the clinical comparability of generic drugs to brand-name drugs within the physician community. The objective of this survey was to assess physicians' perceptions of generic drugs and the generic drug approval process. A survey was administered to a national sample of primary care internists and specialists between August 2014 and January 2015. In total, 1,152 physicians comprising of internists with no reported specialty certification and those with specialty certification in hematology, infectious diseases, and endocrinology were surveyed. The survey assessed physicians' perceptions of the FDA's generic drug approval process, as well as their experiences prescribing six generic drugs approved between 2008 and 2012 using product-specific approval pathways and selected comparator drugs. Among 718 respondents (62% response rate), a majority were comfortable with the FDA's process in ensuring the safety and effectiveness of generic drugs overall (91%) and with letting the FDA determine which tests were necessary to determine bioequivalence in a particular drug (92%). A minority (13-26%) still reported being uncomfortable prescribing generic drugs approved using product-specific pathways. Overall, few physicians heard reports of concerns about generic versions of the study drugs or their comparators, with no differences between the two groups. Physicians tended to hear about concerns about the safety or effectiveness of generic drugs from patients, pharmacists, and physician colleagues. Physicians hold largely positive views of the FDA's generic drug approval process even when some questioned the performance of certain generic drugs in comparison to brand-name drugs. Better education about the generic drug approval process and standards may alleviate concerns among the physician community and support the delivery of cost-effective health care.

Evaluation of safety in clinical use of generic paclitaxel [NK] for injection.

PubMed

Tsukiyama, Ikuto; Hotta, Kazuo; Takeuchi, Masayuki; Onishi, Masahumi; Toyama, Yukio; Saito, Hiroko; Sai, Yoshimichi; Miyamoto, Ken-Ichi; Hasegawa, Takaaki

2012-04-01

The introduction of generic drugs is a favored strategy in reducing medical costs, but some clinicians are often reluctant to use them because of lack of information with regard to their side effects. Generic paclitaxel [NK] differs from the proprietary version, Taxol®, in containing added citric acid and a more pure form of castor oil. However, little information exists regarding the effects of these additives on adverse events such as vascular pain, phlebitis, hypersensitivity and hepatic dysfunction. To compensate for this lack of information and to validate the safety of using generic paclitaxel, we investigated adverse events in response to generic paclitaxel [NK]. Our investigation focused on patients treated with both the proprietary formulation (Taxol® for injection) and the generic version(paclitaxel [NK] for injection)sequentially from April 2008 to March 2009. Adverse events were investigated retrospectively. Incidence of vascular pain, phlebitis and hypersensitivity was similar to that with the original product. Although the expression of some liver enzymes was slightly increased and some gastrointestinal events were reduced following generic paclitaxel [NK] treatment there was no statistically significant difference. The profiles of other adverse events were not significantly different. Increased vascular pain and phlebitis, predicted due to low pH conditions caused by citric acid, were not observed. Similarly, the pure castor oil included in generic paclitaxel [NK] did not influence hypersensitivity and hepatic function. We found no significant differences in our study of proprietary and generic paclitaxel [NK]. Thus, clinicians have no reason for prejudice against using generic paclitaxel [NK] on the basis of increased risk of side effects.

Exploring individual cognitions, self-regulation skills, and environmental-level factors as mediating variables of two versions of a Web-based computer-tailored nutrition education intervention aimed at adults: A randomized controlled trial.

PubMed

Springvloet, Linda; Lechner, Lilian; Candel, Math J J M; de Vries, Hein; Oenema, Anke

2016-03-01

This study explored whether the determinants that were targeted in two versions of a Web-based computer-tailored nutrition education intervention mediated the effects on fruit, high-energy snack, and saturated fat intake among adults who did not comply with dietary guidelines. A RCT was conducted with a basic (tailored intervention targeting individual cognitions and self-regulation), plus (additionally targeting environmental-level factors), and control group (generic nutrition information). Participants were recruited from the general Dutch adult population and randomly assigned to one of the study groups. Online self-reported questionnaires assessed dietary intake and potential mediating variables (behavior-specific cognitions, action- and coping planning, environmental-level factors) at baseline and one (T1) and four (T2) months post-intervention (i.e. four and seven months after baseline). The joint-significance test was used to establish mediating variables at different time points (T1-mediating variables - T2-intake; T1-mediating variables - T1-intake; T2-mediating variables - T2-intake). Educational differences were examined by testing interaction terms. The effect of the plus version on fruit intake was mediated (T2-T2) by intention and fruit availability at home and for high-educated participants also by attitude. Among low/moderate-educated participants, high-energy snack availability at home mediated (T1-T1) the effect of the basic version on high-energy snack intake. Subjective norm mediated (T1-T1) the effect of the basic version on fat intake among high-educated participants. Only some of the targeted determinants mediated the effects of both intervention versions on fruit, high-energy snack, and saturated fat intake. A possible reason for not finding a more pronounced pattern of mediating variables is that the educational content was tailored to individual characteristics and that participants only received feedback for relevant and not for all assessed mediating variables. Netherlands Trial Registry NTR3396. Copyright © 2015. Published by Elsevier Ltd.

Reliability and Validity of the Turkish Version of the PedsQL 3.0 Cancer Module for 2- to 7-Year-Old and the PedsQL 4.0 Generic Core Scales for 5- to 7-Year-Old: The Hacettepe University Experience.

PubMed

Yıldız Kabak, Vesile; Yakut, Yavuz; Çetin, Mualla; Düger, Tülin

2016-09-05

The aim of this study was to investigate the reliability and validity of the Turkish version of the Pediatric Quality of Life Inventory (PedsQL) 3.0 Cancer Module for 2- to 7-year-old and the PedsQL 4.0 Generic Core Scales for 5- to 7-year-old in childhood cancer. The PedsQL 3.0 Cancer Module and PedsQL 4.0 Generic Core Scales were administered to children with cancer and their parents at Hacettepe University. Internal consistency was determined by using Cronbach's alpha and test-retest reliability was determined by using the intraclass correlation coefficient (ICC). Construct validity was assessed by comparing the results of the PedsQL 3.0 Cancer Module with those of the PedsQL 4.0 Generic Core Scales. Cronbach's alpha of the PedsQL 3.0 Cancer Module varied from 0.803 to 0.873 and that of the PedsQL 4.0 Generic Core Scales from 0.665 to 0.841. Test-retest ICC values of the PedsQL 3.0 Cancer Module varied from 0.877 to 0.949 and those of the PedsQL 4.0 Generic Core Scales from 0.681 to 0.824. The correlation of the PedsQL 3.0 Cancer Module with subscale scores of the PedsQL 4.0 Generic Core Scales showed that there were excellent to fair correlations between the two scales. The relationship between parent proxy-report and child self-report of the PedsQL 3.0 Cancer Module had very good correlation (r=0.694, p<0.001), as did the PedsQL 4.0 Generic Core Scales (r=0.540, p=0.002). This study demonstrated the reliability, validity, and feasibility of the Turkish version of the PedsQL 3.0 Cancer Module in 2- to 4-year-old and 5- to 7-year-old and the PedsQL 4.0 Generic Core Scales in 5- to 7-year-old in childhood cancer.

Construct and predictive validity of the German Örebro questionnaire short form for psychosocial risk factor screening of patients with low back pain.

PubMed

Schmidt, Carsten Oliver; Kohlmann, T; Pfingsten, M; Lindena, G; Marnitz, U; Pfeifer, K; Chenot, J F

2016-01-01

Recognizing patients at risk of developing chronic low back pain is essential for targeted interventions. One of the best researched screening instruments for this purpose is the Örebro Musculoskeletal Pain Questionnaire (ÖMSPQ). This work addresses psychometric properties of the German ÖMSPQ short form and its construct and prognostic validity. Analyses are based on a cluster-randomized trial assessing a risk tailored intervention for patients consulting for low back pain in 35 general practices. A total of 360 patients consulting for acute and sub-acute back pain, aged 20-60 years, were included. All patients received a 10-item German short version of the ÖMSPQ, and other generic instruments (Graded Chronic Pain Scale, Patient Health Questionnaire-Depression, Hannover Functional Ability Questionnaire, Fear-Avoidance Beliefs Questionnaire). The construct validity was assessed based on the factorial structure of the items and correlations with generic instruments. The area under the curve (AUC), sensitivity and specificity were calculated as measures of prognostic validity. ÖMSPQ items belonging to the same subscale correlated highest among each other. The internal consistency of the ÖMSPQ items was 0.80 (Cronbach's α). The factorial structure corresponds with theoretic expectations. ÖMSPQ subscales on pain related disability, depression, and fear-avoidance beliefs correlated highest with their counterpart generic scales. The AUC for three ÖMSPQ-based prediction models ranged from 0.77 to 0.81. Our results support a satisfactory factorial and prognostic validity of the German short ÖMSPQ. The instrument may guide the provision of targeted interventions. Further research should link it to targeted treatments.

Driving a decade of change: HIV/AIDS, patents and access to medicines for all

PubMed Central

2011-01-01

Since 2000, access to antiretroviral drugs to treat HIV infection has dramatically increased to reach more than five million people in developing countries. Essential to this achievement was the dramatic reduction in antiretroviral prices, a result of global political mobilization that cleared the way for competitive production of generic versions of widely patented medicines. Global trade rules agreed upon in 1994 required many developing countries to begin offering patents on medicines for the first time. Government and civil society reaction to expected increases in drug prices precipitated a series of events challenging these rules, culminating in the 2001 World Trade Organization's Doha Declaration on the Agreement on Trade-Related Aspects of Intellectual Property Rights and Public Health. The Declaration affirmed that patent rules should be interpreted and implemented to protect public health and to promote access to medicines for all. Since Doha, more than 60 low- and middle-income countries have procured generic versions of patented medicines on a large scale. Despite these changes, however, a "treatment timebomb" awaits. First, increasing numbers of people need access to newer antiretrovirals, but treatment costs are rising since new ARVs are likely to be more widely patented in developing countries. Second, policy space to produce or import generic versions of patented medicines is shrinking in some developing countries. Third, funding for medicines is falling far short of needs. Expanded use of the existing flexibilities in patent law and new models to address the second wave of the access to medicines crisis are required. One promising new mechanism is the UNITAID-supported Medicines Patent Pool, which seeks to facilitate access to patents to enable competitive generic medicines production and the development of improved products. Such innovative approaches are possible today due to the previous decade of AIDS activism. However, the Pool is just one of a broad set of policies needed to ensure access to medicines for all; other key measures include sufficient and reliable financing, research and development of new products targeted for use in resource-poor settings, and use of patent law flexibilities. Governments must live up to their obligations to protect access to medicines as a fundamental component of the human right to health. PMID:21439089

The PedsQL in pediatric cerebral palsy: reliability and validity of the Chinese version pediatric quality of life inventory 4.0 generic core scales and 3.0 cerebral palsy module.

PubMed

Yang, Xue; Xiao, Nong; Yan, Jianying

2011-03-01

This investigation examines the reliability, validity, and sensitivity of the Chinese version Pediatric Quality of Life Inventory (PedsQL) 4.0 Generic Core Scales and 3.0 cerebral palsy (CP) Module in pediatric CP. The study sample was comprised of 126 parents of children with CP between the ages of 2 and 12 years including 18 child respondents 5-12 years of age. Mean age of the 87 boys (69.0%) and 39 girls (31.0%) was 4 years 1 month (SD 2 years 2 month). Reliability was demonstrated for the PedsQL 4.0 (α = 0.86 child, 0.89 parent) and CP Module (α = 0.91 child, 0.96 parent). The PedsQL 4.0 distinguished between healthy children and children with CP. Construct validity of the CP Module was supported through an analysis of the intercorrelations between the Generic Core Scale scores and the CP Module Scale scores and exploratory factor analysis of PedsQL items. The findings provide support for the measurement properties of the Chinese version PedsQL 4.0 Generic Core Scales and 3.0 CP Module in pediatric CP.

Private expenditures on brand name prescription drugs after generic entry.

PubMed

Balaban, Dahlia Y; Dhalla, Irfan A; Law, Michael R; Bell, Chaim M

2013-10-01

Generic drugs offer a less expensive and therapeutically equivalent alternative to brand name drugs. Nevertheless, many Canadian private drug plans continue to pay for brand name drugs even after generics become available. The objective of this study was to quantify the excess spending resulting from this practice. We used the IMS Brogan PharmaStat database to study private-plan drug spending in Ontario from 2000 to 2009. We focused on three widely used drug classes: proton pump inhibitors (PPIs), selective serotonin reuptake inhibitors (SSRIs), and angiotensin-converting enzyme (ACE) inhibitors. For each specific molecule, we determined the difference between what private plans spent on the brand name version and what would have been spent if an available generic version of the same molecule had been purchased instead. We found that prescriptions paid for by private drug plans were often filled with brand name drugs after generics became available. This led to excess private spending of more than Can$107.8 million for these three drug classes over our study period: Can$54.4 million for PPIs, Can$32.4 million for SSRIs and Can$21.0 million for ACE inhibitors. Brand name drugs continue to be reimbursed by Canadian private drug plans at higher prices even after less expensive generic alternatives are available. By mandating generic substitution, substantial cost savings on benefit plans could be achieved.

Reconstruction of genome-scale human metabolic models using omics data.

PubMed

Ryu, Jae Yong; Kim, Hyun Uk; Lee, Sang Yup

2015-08-01

The impact of genome-scale human metabolic models on human systems biology and medical sciences is becoming greater, thanks to increasing volumes of model building platforms and publicly available omics data. The genome-scale human metabolic models started with Recon 1 in 2007, and have since been used to describe metabolic phenotypes of healthy and diseased human tissues and cells, and to predict therapeutic targets. Here we review recent trends in genome-scale human metabolic modeling, including various generic and tissue/cell type-specific human metabolic models developed to date, and methods, databases and platforms used to construct them. For generic human metabolic models, we pay attention to Recon 2 and HMR 2.0 with emphasis on data sources used to construct them. Draft and high-quality tissue/cell type-specific human metabolic models have been generated using these generic human metabolic models. Integration of tissue/cell type-specific omics data with the generic human metabolic models is the key step, and we discuss omics data and their integration methods to achieve this task. The initial version of the tissue/cell type-specific human metabolic models can further be computationally refined through gap filling, reaction directionality assignment and the subcellular localization of metabolic reactions. We review relevant tools for this model refinement procedure as well. Finally, we suggest the direction of further studies on reconstructing an improved human metabolic model.

Ada Compiler Validation Summary Report: Certificate Number: 940305W1. 11335 TLD Systems, Ltd. TLD Comanche VAX/i960 Ada Compiler System, Version 4.1.1 VAX Cluster under VMS 5.5 = Tronix JIAWG Execution Vehicle (i960MX) under TLD Real Time Executive, Version 4.1.1

DTIC Science & Technology

1994-03-14

Comanche VAX/i960 Ada Compiler System, Version 4.1.1 Host Computer System: Digital Local Area Network VAX Cluster executing on (2) MicroVAX 3100 Model 90...31 $MAX DIGITS 15 SmNx INT 2147483647 $MAX INT PLUS_1 2147483648 $MIN IN -2_147483648 A-3 MACR PARAMEERIS $NAME NO SUCH INTEGER TYPE $NAME LIST...nested generlcs are Supported and generics defined in libary units are pexitted. zt is not possible to pen ore a macro instantiation for a generic I

Validation of the Korean version of the pediatric quality of life inventory 4.0 (PedsQL) generic core scales in school children and adolescents using the Rasch model.

PubMed

Kook, Seung Hee; Varni, James W

2008-06-02

The Pediatric Quality of Life Inventory (PedsQL) is a child self-report and parent proxy-report instrument designed to assess health-related quality of life (HRQOL) in healthy and ill children and adolescents. It has been translated into over 70 international languages and proposed as a valid and reliable pediatric HRQOL measure. This study aimed to assess the psychometric properties of the Korean translation of the PedsQL 4.0 Generic Core Scales. Following the guidelines for linguistic validation, the original US English scales were translated into Korean and cognitive interviews were administered. The field testing responses of 1425 school children and adolescents and 1431 parents to the Korean version of PedsQL 4.0 Generic Core Scales were analyzed utilizing confirmatory factor analysis and the Rasch model. Consistent with studies using the US English instrument and other translation studies, score distributions were skewed toward higher HRQOL in a predominantly healthy population. Confirmatory factor analysis supported a four-factor and a second order-factor model. The analysis using the Rasch model showed that person reliabilities are low, item reliabilities are high, and the majority of items fit the model's expectation. The Rasch rating scale diagnostics showed that PedsQL 4.0 Generic Core Scales in general have the optimal number of response categories, but category 4 (almost always a problem) is somewhat problematic for the healthy school sample. The agreements between child self-report and parent proxy-report were moderate. The results demonstrate the feasibility, validity, item reliability, item fit, and agreement between child self-report and parent proxy-report of the Korean version of PedsQL 4.0 Generic Core Scales for school population health research in Korea. However, the utilization of the Korean version of the PedsQL 4.0 Generic Core Scales for healthy school populations needs to consider low person reliability, ceiling effects and cultural differences, and further validation studies on Korean clinical samples are required.

Disciplinary Politics and the Institutionalization of the Generic Triad in Classical Rhetoric.

ERIC Educational Resources Information Center

Liu, Yameng

1995-01-01

Discusses the concepts of rhetoric in general and specifically the generic triad in classical rhetoric. Outlines contemporary versions of the function and realm of rhetoric. Discusses the clash between Aristotle and Quintilian regarding the triad and its relationship to contemporary debates. (HB)

Reliability and validity of the PedsQL™ Generic Core Scales 4.0 for Chinese children with epilepsy.

PubMed

Duan, Xiaoling; Zhang, Shuqing; Xiao, Nong

2012-04-01

This investigation examines the reliability and validity of the Chinese version of the PedsQL 4.0 Generic Core Scales for prognostic measures of pediatric epilepsy. The study comprised 163 parents whose children, between the ages of 2 and 18 years, were diagnosed with epilepsy. The parents were given a questionnaire to be completed on behalf of the child. Reliability was assessed by Cronbach's alpha analysis. Validity was assessed by the exploratory factor analysis and intercorrelation analysis between the four subscales as well as Student's t-test. The internal consistency reliability for Total Scale Score was 0.94 by Cronbach's alpha test. Four major factors were extracted by factor analysis. The scores from all sub-scales derived from healthy children were significantly higher than children with epilepsy (P<0.001). The reliability and validity of the parent proxy-report scales from the Chinese version of the PedsQL™ 4.0 Generic Core Scales effectively matched the original version and could be used to evaluate the health-related quality of life of children with epilepsy. Copyright © 2012 Elsevier Inc. All rights reserved.

Comparative effectiveness of generic versus brand-name antiepileptic medications.

PubMed

Gagne, Joshua J; Kesselheim, Aaron S; Choudhry, Niteesh K; Polinski, Jennifer M; Hutchins, David; Matlin, Olga S; Brennan, Troyen A; Avorn, Jerry; Shrank, William H

2015-11-01

The objective of this study was to compare treatment persistence and rates of seizure-related events in patients who initiate antiepileptic drug (AED) therapy with a generic versus a brand-name product. We used linked electronic medical and pharmacy claims data to identify Medicare beneficiaries who initiated one of five AEDs (clonazepam, gabapentin, oxcarbazepine, phenytoin, zonisamide). We matched initiators of generic versus brand-name versions of these drugs using a propensity score that accounted for demographic, clinical, and health service utilization variables. We used a Cox proportional hazards model to compare rates of seizure-related emergency room (ER) visit or hospitalization (primary outcome) and ER visit for bone fracture or head injury (secondary outcome) between the matched generic and brand-name initiators. We also compared treatment persistence, measured as time to first 14-day treatment gap, between generic and brand-name initiators. We identified 19,760 AED initiators who met study eligibility criteria; 18,306 (93%) initiated a generic AED. In the matched cohort, we observed 47 seizure-related hospitalizations and ER visits among brand-name initiators and 31 events among generic initiators, corresponding to a hazard ratio of 0.53 (95% confidence interval, 0.30 to 0.96). Similar results were observed for the secondary clinical endpoint and across sensitivity analyses. Mean time to first treatment gap was 124.2 days (standard deviation [sd], 125.8) for brand-name initiators and 137.9 (sd, 148.6) for generic initiators. Patients who initiated generic AEDs had fewer adverse seizure-related clinical outcomes and longer continuous treatment periods before experiencing a gap than those who initiated brand-name versions. Copyright © 2015 Elsevier Inc. All rights reserved.

The physical properties of generic latanoprost ophthalmic solutions are not identical.

PubMed

Kolko, Miriam; Koch Jensen, Peter

2017-06-01

To compare various characteristics of Xalatan ® and five generic latanoprost ophthalmic solutions. Drop size, volume, pH values, buffer capacity, viscosity, hardness of bottles and costs were determined. Drop sizes were measured in triplicates by micropipettes, and the number of drops counted in three separate bottles of each generic product was determined. pH values were measured in triplicates by a calibrated pH meter. Buffer capacity was exploited by titrating known quantities of strong base into 2.5 ml of each brand and interpolated to neutral pH. Kinematic viscosity was determined by linear regression of timed gravity flow from a vertical syringe through a 21-G cannula. The hardness of the bottles was evaluated by gradually increasing tension on a hook placed around each bottle until a drop was expelled reading the tension on an attached spring scale. Drop sizes and the number of drops in the bottles varied significantly between the generic drugs. The control value of pH in the brand version (Xalatan ® ) was markedly lower compared to the generic latanoprost products. Titration of Xalatan ® to neutrality required substantially more NaOH compared to the generic latanoprost products. Finally, the viscosity revealed a significant variability between brands. Remarkable differences were found in bottle shapes, bottle hardness and costs of the latanoprost generics. Generic latanoprost eye drops should not be considered identical to the original brand version as regards to drop size, volumes, pH values, buffer capacity, viscosity, hardness of bottles and costs. It is likely that these issues affect compliance and intraocular pressure (IOP)-lowering effect. Therefore, re-evaluation of the requirements for introducing generic eye drops seems reasonable. © 2017 Acta Ophthalmologica Scandinavica Foundation. Published by John Wiley & Sons Ltd.

A generic model of contagious disease and its application to human-to-human transmission of avian influenza.

DOE Office of Scientific and Technical Information (OSTI.GOV)

Hirsch, Gary B.

2007-03-01

Modeling contagious diseases has taken on greater importance over the past several years as diseases such as SARS and avian influenza have raised concern about worldwide pandemics. Most models developed to consider projected outbreaks have been specific to a single disease. This paper describes a generic System Dynamics contagious disease model and its application to human-to-human transmission of a mutant version of avian influenza. The model offers the option of calculating rates of new infections over time based either on a fixed ''reproductive number'' that is traditional in contagious disease models or on contact rates for different sub-populations and likelihoodmore » of transmission per contact. The paper reports on results with various types of interventions. These results suggest the potential importance of contact tracing, limited quarantine, and targeted vaccination strategies as methods for controlling outbreaks, especially when vaccine supplies may initially be limited and the efficacy of anti-viral drugs uncertain.« less

Reliability and Validity of the Turkish Version of the PedsQL 3.0 Cancer Module for 2- to 7-Year-Old and the PedsQL 4.0 Generic Core Scales for 5- to 7-Year-Old: The Hacettepe University Experience

PubMed Central

Yıldız Kabak, Vesile; Yakut, Yavuz; Çetin, Mualla; Düger, Tülin

2016-01-01

Objective: The aim of this study was to investigate the reliability and validity of the Turkish version of the Pediatric Quality of Life Inventory (PedsQL) 3.0 Cancer Module for 2- to 7-year-old and the PedsQL 4.0 Generic Core Scales for 5- to 7-year-old in childhood cancer. Materials and Methods: The PedsQL 3.0 Cancer Module and PedsQL 4.0 Generic Core Scales were administered to children with cancer and their parents at Hacettepe University. Internal consistency was determined by using Cronbach’s alpha and test-retest reliability was determined by using the intraclass correlation coefficient (ICC). Construct validity was assessed by comparing the results of the PedsQL 3.0 Cancer Module with those of the PedsQL 4.0 Generic Core Scales. Results: Cronbach’s alpha of the PedsQL 3.0 Cancer Module varied from 0.803 to 0.873 and that of the PedsQL 4.0 Generic Core Scales from 0.665 to 0.841. Test-retest ICC values of the PedsQL 3.0 Cancer Module varied from 0.877 to 0.949 and those of the PedsQL 4.0 Generic Core Scales from 0.681 to 0.824. The correlation of the PedsQL 3.0 Cancer Module with subscale scores of the PedsQL 4.0 Generic Core Scales showed that there were excellent to fair correlations between the two scales. The relationship between parent proxy-report and child self-report of the PedsQL 3.0 Cancer Module had very good correlation (r=0.694, p<0.001), as did the PedsQL 4.0 Generic Core Scales (r=0.540, p=0.002). Conclusion: This study demonstrated the reliability, validity, and feasibility of the Turkish version of the PedsQL 3.0 Cancer Module in 2- to 4-year-old and 5- to 7-year-old and the PedsQL 4.0 Generic Core Scales in 5- to 7-year-old in childhood cancer. PMID:27095607

Does GastroPlus Support Similarity and Dissimilarity Factors of in vitro-in vivo Prediction in Biowaiver Studies? A Lower Strength Amlodipine As a Model Drug.

PubMed

Naser Zaid, Abdel; Shraim, Naser; Radwan, Asmaa; Jaradat, Nidal; Hirzallah, Samah; Issa, Ibrahim; Khraim, Aya

2018-05-23

Many generic pharmaceutical products are currently available on the market place worldwide. Recently, there is a growing concern on the quality and efficacy of generic products. However, health care professionals such as physicians and pharmacists are in difficult situations to choose among alternatives. The aim of this study is to assess the effectiveness of the in silico technique (Gastro Plus ® ) in the biowaiver study and whether similarity and dissimilarity factors ( f 2 and f 1 respectively) are effective in this regard. The concentration of amlodipine in the sample was calculated by comparing the absorbance of the sample with that of a previously prepared amlodipine standard solution using validated HPLC method. The dissolution profile for each product (brand and generics) was constructed. The similarity ( f2) and dissimilarity ( f 1 ) factors were calculated for the generic product according to equation 1 and 2. GastroPlus™ software (version 9.0, Simulations Plus Inc., Lancaster, CA, USA) was used to predict the absorption profiles of amlodipine from the generic product Amlovasc ® and the reference Norvasc ® . These results may provide a rationale for the interchangeability between the RLD and generic version based on in vitro release profiles in silico technique especially in a lower strength dose drug. © Georg Thieme Verlag KG Stuttgart · New York.

Planned development and evaluation protocol of two versions of a web-based computer-tailored nutrition education intervention aimed at adults, including cognitive and environmental feedback

PubMed Central

2014-01-01

Background Despite decades of nutrition education, the prevalence of unhealthy dietary patterns is still high and inequalities in intake between high and low socioeconomic groups still exist. Therefore, it is important to innovate and improve existing nutrition education interventions. This paper describes the development, design and evaluation protocol of a web-based computer-tailored nutrition education intervention for adults targeting fruit, vegetable, high-energy snack and fat intake. This intervention innovates existing computer-tailored interventions by not only targeting motivational factors, but also volitional and self-regulation processes and environmental-level factors. Methods/design The intervention development was guided by the Intervention Mapping protocol, ensuring a theory-informed and evidence-based intervention. Two versions of the intervention were developed: a basic version targeting knowledge, awareness, attitude, self-efficacy and volitional and self-regulation processes, and a plus version additionally addressing the home environment arrangement and the availability and price of healthy food products in supermarkets. Both versions consist of four modules: one for each dietary behavior, i.e. fruit, vegetables, high-energy snacks and fat. Based on the self-regulation phases, each module is divided into three sessions. In the first session, feedback on dietary behavior is provided to increase awareness, feedback on attitude and self-efficacy is provided and goals and action plans are stated. In the second session goal achievement is evaluated, reasons for failure are explored, coping plans are stated and goals can be adapted. In the third session, participants can again evaluate their behavioral change and tips for maintenance are provided. Both versions will be evaluated in a three-group randomized controlled trial with measurements at baseline, 1-month, 4-months and 9-months post-intervention, using online questionnaires. Both versions will be compared with a generic nutrition information control condition. The primary outcomes are fruit, vegetable, high-energy snack and fat intake. Discussion The evaluation study will provide insight into the short- and long-term efficacy of both intervention versions in adults. Additionally, differences in the efficacy among high- and low-educated people will be examined. If these interventions are effective, two well-developed interventions will become available for the implementation and promotion of healthy dietary patterns among both high- and low-educated adults in the Netherlands. Trial registration Dutch Trial Registry NTR3396. PMID:24438381

Planned development and evaluation protocol of two versions of a web-based computer-tailored nutrition education intervention aimed at adults, including cognitive and environmental feedback.

PubMed

Springvloet, Linda; Lechner, Lilian; Oenema, Anke

2014-01-17

Despite decades of nutrition education, the prevalence of unhealthy dietary patterns is still high and inequalities in intake between high and low socioeconomic groups still exist. Therefore, it is important to innovate and improve existing nutrition education interventions. This paper describes the development, design and evaluation protocol of a web-based computer-tailored nutrition education intervention for adults targeting fruit, vegetable, high-energy snack and fat intake. This intervention innovates existing computer-tailored interventions by not only targeting motivational factors, but also volitional and self-regulation processes and environmental-level factors. The intervention development was guided by the Intervention Mapping protocol, ensuring a theory-informed and evidence-based intervention. Two versions of the intervention were developed: a basic version targeting knowledge, awareness, attitude, self-efficacy and volitional and self-regulation processes, and a plus version additionally addressing the home environment arrangement and the availability and price of healthy food products in supermarkets. Both versions consist of four modules: one for each dietary behavior, i.e. fruit, vegetables, high-energy snacks and fat. Based on the self-regulation phases, each module is divided into three sessions. In the first session, feedback on dietary behavior is provided to increase awareness, feedback on attitude and self-efficacy is provided and goals and action plans are stated. In the second session goal achievement is evaluated, reasons for failure are explored, coping plans are stated and goals can be adapted. In the third session, participants can again evaluate their behavioral change and tips for maintenance are provided. Both versions will be evaluated in a three-group randomized controlled trial with measurements at baseline, 1-month, 4-months and 9-months post-intervention, using online questionnaires. Both versions will be compared with a generic nutrition information control condition. The primary outcomes are fruit, vegetable, high-energy snack and fat intake. The evaluation study will provide insight into the short- and long-term efficacy of both intervention versions in adults. Additionally, differences in the efficacy among high- and low-educated people will be examined. If these interventions are effective, two well-developed interventions will become available for the implementation and promotion of healthy dietary patterns among both high- and low-educated adults in the Netherlands. Dutch Trial Registry NTR3396.

Generic Verification Protocol for Testing Pesticide Application Spray Drift Reduction Technologies for Row and Field Crops (Version 1.4)

EPA Science Inventory

This generic verification protocol provides a detailed method for conducting and reporting results from verification testing of pesticide application technologies. It can be used to evaluate technologies for their potential to reduce spray drift, hence the term “drift reduction t...

[Validity and reliability of Pediatric Quality of Life Inventory Version 4.0 Generic Core Scales in Chinese children and adolescents].

PubMed

Chen, Yu-Ming; He, Li-Ping; Mai, Jin-Cheng; Hao, Yuan-Tao; Xiong, Li-Hua; Chen, Wei-Qing; Wu, Jiang-Nan

2008-06-01

To evaluate the reliability and validity of parent proxy-report scales of Pediatric Quality of Life Inventory Version 4.0 (PedsQL 4.0) Generic Core Scales, the Chinese Version. 3493 school students aged 6-18 years were recruited using multistage cluster sampling method. Health-related quality of life was assessed using the above-mentioned PedsQL 4.0 scales. The internal consistency was assessed, using Cronbach's a coefficient, while its validity was tested through correlation analysis, t-test and exploratory factor analysis. The internal consistency reliability for Total Scale Score (Cronbach's alpha = 0.90), Physical Health Summary Score (alpha= 0.81), and Psychosocial Health Summary Score (alpha= 0.89) were excellent. Six major factors were extracted by factor analysis which basically matched the designed structure of the original version accounting for nearly 66% of the variance. The total Scale Score significantly decreased by 3.5 to 13.3 (P < 0.05) in children and adolescents who had diseases including cold, skin hypersensitiveness, food allergy, courbature or arthralgia, breathlessness with a frequency of 6 times or more per year or had asthma as compared to those with lower frequency (< or = 5 times/y) of the diseases or without asthma. We found moderate to high correlations between items and the subscales. Correlation coefficients ranged between 0.45 to 0.84 (P < 0.01). The reliability and validity of the parent proxy-report scales of PedsQL 4.0 Generic Core Scales of the Chinese Version were as good as the original version. Our findings suggested that the scales could be applied to evaluate the health-related quality of life in childhood children in similar Chinese regions to Guangzhou.

Generic medicines: solutions for a sustainable drug market?

PubMed

Dylst, Pieter; Vulto, Arnold; Godman, Brian; Simoens, Steven

2013-10-01

Generic medicines offer equally high-quality treatment as originator medicines do at much lower prices. As such, they represent a considerable opportunity for authorities to obtain substantial savings. At the moment, the pharmaceutical landscape is changing and many pharmaceutical companies have altered their development and commercial strategies, combining both originator and generic divisions. In spite of this, the generic medicines industry is currently facing a number of challenges: delayed market access; the limited price differential with originator medicines; the continuous downwards pressure on prices; and the negative perception regarding generic medicines held by some key stakeholder groups. This could jeopardize the long-term sustainability of the generic manufacturing industry. Therefore, governments must focus on demand-side policies, alongside policies to accelerate market access, as the generic medicines industry will only be able to deliver competitive and sustainable prices if they are ensured a high volume. In the future, the generic medicines industry will increasingly look to biosimilars and generic versions of orphan drugs to expand their business.

GOMMA: a component-based infrastructure for managing and analyzing life science ontologies and their evolution

PubMed Central

2011-01-01

Background Ontologies are increasingly used to structure and semantically describe entities of domains, such as genes and proteins in life sciences. Their increasing size and the high frequency of updates resulting in a large set of ontology versions necessitates efficient management and analysis of this data. Results We present GOMMA, a generic infrastructure for managing and analyzing life science ontologies and their evolution. GOMMA utilizes a generic repository to uniformly and efficiently manage ontology versions and different kinds of mappings. Furthermore, it provides components for ontology matching, and determining evolutionary ontology changes. These components are used by analysis tools, such as the Ontology Evolution Explorer (OnEX) and the detection of unstable ontology regions. We introduce the component-based infrastructure and show analysis results for selected components and life science applications. GOMMA is available at http://dbs.uni-leipzig.de/GOMMA. Conclusions GOMMA provides a comprehensive and scalable infrastructure to manage large life science ontologies and analyze their evolution. Key functions include a generic storage of ontology versions and mappings, support for ontology matching and determining ontology changes. The supported features for analyzing ontology changes are helpful to assess their impact on ontology-dependent applications such as for term enrichment. GOMMA complements OnEX by providing functionalities to manage various versions of mappings between two ontologies and allows combining different match approaches. PMID:21914205

The Psychometric Properties of an Arabic version of the PedsQL Multidimensional Fatigue Scale Tested for Children with Cancer.

PubMed

Al-Gamal, Ekhlas; Long, Tony

2017-09-01

Fatigue is considered to be one of the most reported symptoms experienced by children with cancer. A major aim of this study was to develop an Arabic version of the Pediatric Quality of Life (PedsQL) Multidimensional Fatigue Scale (child report) and to test its psychometric proprieties for the assessment of fatigue in Arabic children with cancer. The PedsQL Multidimensional Fatigue Scale (Arabic version) and the PedsQL TM 4.0 Generic Core scale (existing Arabic version) were completed by 70 Jordanian children with cancer. Cronbach's alpha coefficients were found to be 0.90 for the total PedsQL Multidimensional Fatigue Scale (Arabic version), 0.94 for the general fatigue subscale, 0.67 for the sleep/rest fatigue subscale, and 0.87 for the cognitive fatigue subscale. The PedsQL Multidimensional Fatigue Scale scores correlated significantly with the PedsQL TM 4.0 Generic Core scale and demonstrated good construct validity. The results demonstrate excellent reliability and good validity of the PedsQL Multidimensional Fatigue Scale (Arabic version) for children with cancer. This is the first validated scale that assesses fatigue in Arabic children with cancer. The English scale has been used with several pediatric clinical populations, so this Arabic version may be equally useful beyond the field of cancer.

Analysis of French generic medicines retail market: why the use of generic medicines is limited.

PubMed

Dylst, Pieter; Vulto, Arnold; Simoens, Steven

2014-12-01

The market share of generic medicines in France is low compared to other European countries. This perspective paper provides an overview of the generic medicines retail market in France and how the current policy environment may affect the long-term sustainability. Looking at the French generic medicines retail market and the surrounding regulatory framework, all conditions seem to be in place to create a healthy generic medicines market: the country has well-respected regulatory authorities, generic medicines enter the market in a timely manner and prices of generic medicines are competitive compared with other European countries. Despite the success of the demand-side policies targeted at pharmacists and patients, those targeted at physicians were less successful due to a lack of enforcement and a lack of trust in generic medicines by French physicians. Recommendations to increase the use of generic medicines in France round off this perspective paper.

Reliability and validity of the Iranian version of the Pediatric Quality of Life Inventory™ 4.0 Generic Core Scales in adolescents.

PubMed

Amiri, Parisa; M Ardekani, Emad; Jalali-Farahani, Sara; Hosseinpanah, Farhad; Varni, James W; Ghofranipour, Fazlollah; Montazeri, Ali; Azizi, Fereidoun

2010-12-01

The objective of this study was to investigate the reliability and validity of the Iranian version of the Pediatric Quality of Life Inventory™ 4.0 (PedsQL™ 4.0) Generic Core Scales in adolescents After linguistic validation, the Iranian version of the PedsQL™ 4.0 was completed by 848 healthy and 26 chronically ill adolescents aged 13-18 years and their parents. The internal consistency as measured by Cronbach's alpha coefficients exceeded the minimum reliability standard of .70. No floor effects were observed. Ceiling effects detected ranged from 1.5% for adolescent self-report total scale score to 42.2% for self-report social functioning. All monotrait-multimethod correlations were higher than multitrait-multimethod correlations. The intraclass correlation coefficients (ICC) between adolescent self-report and parent proxy-report showed good to excellent agreement. Exploratory factor analysis supported mainly comparable results with the original US English dialect version. The results of the confirmatory factor analysis for 5-factor models for both self-report and proxy-report indicated acceptable fit for the proposed models. Regarding gender and health status, as hypothesized from previous studies, girls reported lower health-related quality of life than boys on the total score, physical and emotional functioning, and healthy adolescents reported significantly higher health-related quality of life than those with chronic illnesses. The findings support the initial reliability and validity of the Iranian version of the PedsQL™ 4.0 as a generic instrument to measure HRQOL of adolescents in Iran.

Can the Integration of a PLE in an E-Portfolio Platform Improve Generic Competences?

ERIC Educational Resources Information Center

Galván-Fernández, Cristina; Rubio-Hurtado, María José; Martínez-Olmo, Francesc; Rodríguez-Illera, José Luis

2017-01-01

The study analyzes the improvement in generic competences through e-portfolio/PLE platform and didactic planning. The new version of the platform, Digital Folder, contains utilities for students and teachers and some PLE components that help the learning process through e-portfolios. Didactic planning is compared for students from the University…

Generic ABILHAND Questionnaire Can Measure Manual Ability across a Variety of Motor Impairments

ERIC Educational Resources Information Center

Simone, Anna; Rota, Viviana; Tesio, Luigi; Perucca, Laura

2011-01-01

ABILHAND is, in its original version, a 46-item, 4-level questionnaire. It measures the difficulty perceived by patients with rheumatoid arthritis as they do various daily manual tasks. ABILHAND was originally built through Rasch analysis. In a later study, it was simplified to a generic 23-item, three-level questionnaire, showing both…

Differentiating low-molecular-weight heparins based on chemical, biological, and pharmacologic properties: implications for the development of generic versions of low-molecular-weight heparins.

PubMed

Jeske, Walter P; Walenga, Jeanine M; Hoppensteadt, Debra A; Vandenberg, Curtis; Brubaker, Aleah; Adiguzel, Cafer; Bakhos, Mamdouh; Fareed, Jawed

2008-02-01

Low-molecular-weight heparins (LMWHs) are polypharmacologic drugs used to treat thrombotic and cardiovascular disorders. These drugs are manufactured using different chemical and enzymatic methods, resulting in products with distinct chemical and pharmacologic profiles. Generic LMWHs have been introduced in Asia and South America, and several generic suppliers are seeking regulatory approval in the United States and the European Union. For simple small-molecule drugs, generic drugs have the same chemical structure, potency, and bioavailability as the innovator drug. Applying this definition to complex biological products such as the LMWHs has proved difficult. One major issue is defining appropriate criteria to demonstrate bioequivalence; pharmacopoeial specifications alone appear to be inadequate. Whereas available generic versions of LMWHs exhibit similar molecular and pharmacopoeial profiles, marked differences in their biological and pharmacologic behavior have been noted. Preliminary studies have demonstrated differences in terms of anti-Xa activity and tissue factor pathway inhibitor release after subcutaneous administration, as well as antiplatelet and profibrinolytic effects. The current data emphasize the need to consider multiple functional parameters when defining bioequivalence of biologic drugs with complex structures and activities and also underscore the importance of further pharmacologic studies involving animal models and human clinical trials. The U.S. Food and Drug Administration and the European Medicine Evaluation Agency are currently developing guidelines for the acceptance of biosimilar agents including LMWHs. Until such guidelines are complete, generic interchange may not be feasible.

Predicted savings to the UK National Health Service from switching to generic antiretrovirals, 2014-2018.

PubMed

Hill, Andrew; Hill, Teresa; Jose, Sophie; Pozniak, Anton

2014-01-01

In other disease areas, generic drugs are normally used after patent expiry. Patents on zidovudine, lamivudine, nevirapine and efavirenz have already expired. Patents will expire for abacavir in late 2014, lopinavir/r in 2016, and tenofovir, darunavir and atazanavir in 2017. However, patents on single-tablet regimens do not expire until after 2026. The number of people taking each antiretroviral in the UK was estimated from 23,655 individuals in the UK CHIC cohort (2012 database). Costs of patented drugs were taken from the British National Formulary database, assuming a 30% discount. Costs of generic antiretrovirals were estimated using an 80% discount from patented prices, or actual costs where available. Two options were analysed: 1 - all patients use single-tablet regimens and patented versions of drugs; prices remain stable over time; 2 - all people switch from patented to generic drugs when available, after patent expiry (dates shown above). There were an estimated 67,000 people taking antiretrovirals in the UK in 2014, estimated to rise by 8% per year until 2018 (in line with previous rises). The most widely used antiretrovirals in the CHIC cohort were tenofovir (TDF) (75%), emtricitabine (FTC) (69%), efavirenz (EFV) (39%), lamivudine (3TC) (23%), abacavir (ABC) (18%), darunavir (DRV) (21%) and atazanavir (ATV) (16%). The predicted annual UK cost of generic ABC/3TC/EFV (three generic tablets once daily) was £1018 per person-year. Costs of patented single-tablet regimens ranged from £5000 to £7500 per person-year. Assuming continued use of patented antiretrovirals in the UK, the predicted total national costs of antiretroviral treatment were predicted to rise from £425 million in 2014 to £459 m in 2015, £495 m in 2016, £536 m in 2017 and £578 m in 2018. With a 100% switch to generics, total predicted costs were £337 m in 2014, £364 m in 2015, £382 m in 2016, £144 m in 2017 and £169 m in 2018. The total predicted saving over five years from a switch to generics was £1.1 billion. Systematic switching from patented to generic antiretrovirals could potentially save approximately £1.1 billion in the UK over the next five years, compared with continued use of patented versions: this money could be spent on urgently needed HIV prevention programmes. Similar savings are feasible for other European countries, given parallel patent expiry dates. More detailed economic evaluation is required to show when patented single-tablet regimens provide value for money, compared to bioequivalent generic versions of 3-4 pills once daily.

Assessing health-related quality of life in Japanese children with a chronic condition: validation of the DISABKIDS chronic generic module.

PubMed

Sasaki, Hatoko; Kakee, Naoko; Morisaki, Naho; Mori, Rintaro; Ravens-Sieberer, Ulrike; Bullinger, Monika

2018-05-02

This study examined the reliability and validity of the Japanese versions of the DISABKIDS-37 generic modules, a tool for assessing the health-related quality of life (HRQOL) of children and adolescents with a chronic condition. The study was conducted using a sample of 123 children/adolescents with a chronic medical condition, aged 8-18 years, and their parents. Focus interviews were performed to ensure content validity after translation. The classical psychometric tests were used to assess reliability and scale intercorrelations. The factor structure was examined with confirmatory factor analysis (CFA). Convergent validity was assessed by the correlation between the total score and the sub-scales of DISABKIDS-37 as well as the total score of KIDSCREEN-10. Both the children/adolescent and parent versions of the score showed good to high internal consistency, and the test-retest reliability correlations were r = 0.91 or above. The CFA revealed that the modified models for all domains were better fit than the original 37 item scale model for both self-report and proxy-report. Moderate to high positive correlations were found for the associations within DISABKIDS-37 sub-scales and between the subscales and total score, except for the treatment sub-scale, which correlated weakly with the remaining sub-scales. The total score of the child-reported version of KIDSCREEN-10 correlated significantly and positively with the total score and all the sub-scales of the child-reported version of DISABKIDS-37 except the Treatment sub-scale in adolescents. The modified models of Japanese version of DISABKIDS generic module were psychometrically robust enough to assess the HRQOL of children with a chronic condition.

Psychometric properties of the Sinhala version of the PedsQL™ 4.0 Generic Core Scales in early adolescents in Sri Lanka.

PubMed

Danansuriya, Manjula Nishanthi; Rajapaksa, Lalini C

2012-09-04

The concept Health related Quality of life (HRQOL) is increasingly recognized as an important health outcome measure in clinical and research fields. The present study attempted to evaluate the psychometric properties of the Sinhala version of the Pediatric Quality of Life Inventory™ 4.0 (PedsQL™ 4.0) Generic Core Scales among adolescents in Sri Lanka. The original US PedsQL™ was translated into Sinhala and conceptually validated according to international guidelines. A cross-sectional study was conducted among 142 healthy school going adolescents (12-14 years), their parents (n = 120) and a group of adolescents with asthma who attended asthma clinics (n = 115). Reliability was assessed using Cronbach's alpha and validity by examining scale structure, exploring inter-scale correlations and comparing across known groups (healthy vs. chronically ill). The PedsQL™ Sinhala version was found to be acceptable with minimal missing responses. All scales demonstrated satisfactory reliability. Cronbach's alpha for the total scale scores was 0.85 for adolescent self-report while for the parent proxy-report for the healthy group it was 0.86. No floor effects were observed. Ceiling effects were noticed in self-report and parent proxy-report for the healthy group. Overall results of the multi trait scaling analysis confirmed the scale structure with 74% item-convergent validity, 88% item-discriminant validity and an overall scaling success of 72%. Moderate to high correlations were shown among the domains of teen self-report (Spearman rho = .37-.54) and between teen self-report and parent proxy-reports (Spearman rho = .41-.57). The PedsQL™ tool was able to discriminate between the quality of life in healthy adolescents and adolescents with asthma. The findings support the reliability and validity of the Sinhala version of the PedsQL™ 4.0 Generic Core Scales as a generic instrument to measure HRQOL among early adolescents in Sri Lanka in a population setting.

Highly Accurate Beam Torsion Solutions Using the p-Version Finite Element Method

NASA Technical Reports Server (NTRS)

Smith, James P.

1996-01-01

A new treatment of the classical beam torsion boundary value problem is applied. Using the p-version finite element method with shape functions based on Legendre polynomials, torsion solutions for generic cross-sections comprised of isotropic materials are developed. Element shape functions for quadrilateral and triangular elements are discussed, and numerical examples are provided.

Smart Plasmonic Glucose Nanosensors as Generic Theranostic Agents for Targeting-Free Cancer Cell Screening and Killing.

PubMed

Chen, Limei; Li, Haijuan; He, Haili; Wu, Haoxi; Jin, Yongdong

2015-07-07

Fast and accurate identification of cancer cells from healthy normal cells in a simple, generic way is very crucial for early cancer detection and treatment. Although functional nanoparticles, like fluorescent quantum dots and plasmonic Au nanoparticles (NPs), have been successfully applied for cancer cell imaging and photothermal therapy, they suffer from the main drawback of needing time-consuming targeting preparation for specific cancer cell detection and selective ablation. The lack of a generic and effective method therefore limits their potential high-throughput cancer cell preliminary screening and theranostic applications. We report herein a generic in vitro method for fast, targeting-free (avoiding time-consuming preparations of targeting moiety for specific cancer cells) visual screening and selective killing of cancer cells from normal cells, by using glucose-responsive/-sensitive glucose oxidase-modified Ag/Au nanoshells (Ag/Au-GOx NSs) as a smart plasmonic theranostic agent. The method is generic to some extent since it is based on the distinct localized surface plasmon resonance (LSPR) responses (and colors) of the smart nanoprobe with cancer cells (typically have a higher glucose uptake level) and normal cells.

How drug life-cycle management patent strategies may impact formulary management.

PubMed

Berger, Jan; Dunn, Jeffrey D; Johnson, Margaret M; Karst, Kurt R; Shear, W Chad

2016-10-01

Drug manufacturers may employ various life-cycle management patent strategies, which may impact managed care decision making regarding formulary planning and management strategies when single-source, branded oral pharmaceutical products move to generic status. Passage of the Hatch-Waxman Act enabled more rapid access to generic medications through the abbreviated new drug application process. Patent expirations of small-molecule medications and approvals of generic versions have led to substantial cost savings for health plans, government programs, insurers, pharmacy benefits managers, and their customers. However, considering that the cost of developing a single medication is estimated at $2.6 billion (2013 dollars), pharmaceutical patent protection enables companies to recoup investments, creating an incentive for innovation. Under current law, patent protection holds for 20 years from time of patent filing, although much of this time is spent in product development and regulatory review, leaving an effective remaining patent life of 7 to 10 years at the time of approval. To extend the product life cycle, drug manufacturers may develop variations of originator products and file for patents on isomers, metabolites, prodrugs, new drug formulations (eg, extended-release versions), and fixed-dose combinations. These additional patents and the complexities surrounding the timing of generic availability create challenges for managed care stakeholders attempting to gauge when generics may enter the market. An understanding of pharmaceutical patents and how intellectual property protection may be extended would benefit managed care stakeholders and help inform decisions regarding benefit management.

Some psychometric properties of the Pediatric Quality of Life Inventory™ Version 4.0 Generic Core Scales (PedsQL™) in the general Serbian population.

PubMed

Stevanović, Dejan; Lakić, Aneta; Damnjanović, Maja

2011-08-01

The aim of this study was to evaluate the general measurement properties of the Serbian version of the Pediatric Quality of Life Inventory™ Version 4.0 Generic Core Scales (PedsQL™) self-report versions for children and adolescents (8-18 years). The PedsQL™ was completed by 238 children and adolescents. The version was descriptively analyzed first. Afterward, internal consistency and construct and convergent validity were analyzed using the classic test theory psychometrical procedures. The PedsQL™ scale score means ranged 70.65-88.34, with the total score was 80.74. Scale internal consistency reliability determined by Cronbach's coefficient was above 0.7 for all except the School, 0.65, and Emotional Functioning Scale, 0.69. The statistics assessing the adequacy of the model in confirmatory factor analysis revealed poor model fit for the current structure of the PedsQL™. Finally, the PedsQL™ total and psychosocial health showed convincing negative correlations with emotional and conduct problems, hyperactivity/inattention, and peer relationship problems. The Serbian PedsQL™ scales have appropriate internal consistency reliability, sufficient for group evaluations, and good convergent validity against psychological constructs. However, there are problems regarding its current construct validity (factorial validity).

[Polish version of the ADOS (autism diagnostic observation schedule-generic)].

PubMed

Chojnicka, Izabela; Płoski, Rafał

2012-01-01

The article presents the Polish version of the autism diagnostic observation schedule-generic (ADOS), which together with the autism diagnostic interview-revised (ADI-R) is cited as the "gold standard" for the diagnosis of autism. The ADOS is a standardised, semistructured observation protocol appropriate for children and adults of differing age and language levels. It is linked to ICD-10 and DSM-IV-TR criteria. The ADOS consists of four modules, ranging from module 1 for nonverbal individuals to module 4 for verbally fluent adults. The adequate inter-rater reliability for items has been established. The protocol has high discriminant validity and distinguishes children with pervasive developmental disorders from children, who are outside of the spectrum. Although it does not enable to distinguish individuals with pervasive developmental disorder, unspecified from individuals with childhood autism. The paper presents subsequent steps of the translation process of the original version into Polish, as well as a chosen adaptation strategy of the Polish version. The ADOS is a very useful tool both for clinical diagnosis and for the scientific purpose diagnosis. In this last case it is extremely important to use a standardised method. Until now, there was no standardised diagnostic tool for autism in Poland.

[SF-36 and EQ-5D in the evaluation of QOL in the osteoporotic patients as the generic questionnaires].

PubMed

Tanaka, Kiyoshi; Fujii, Ayano; Kuwabara, Akiko

2012-02-01

Health-related quality of life (HRQOL) , abbreviated as QOL, can be evaluated by various questionnaires, which are classified as generic and disease-targeted ones. Generic questionnaires are further subdivided into profile-type and preference-based ones. SF-36 and EQ-5D are the best known examples for the former and the latter, respectively. In SF-36 and its shortened one SF-8, the subjects' QOL is expressed by several profiles or subscales. Their advantages include well-conducted validation and availability of national norms. In EQ-5D, a single value representing the subjects' QOL status (utility) is obtained through 5 questions. These generic questionnaires are applicable to patients with various diseases or even to healthy citizens. In contrast, disease-targeted questionnaires lack such features, but can include items that are specifically related to the disease but devoid of general applicability. Thus, generic and disease-targeted questionnaires have their own pros and cons. Selection of the questionnaires depends on the object of the study.

Development and validation of a tool to assess knowledge and attitudes towards generic medicines among students in Greece: The ATtitude TOwards GENerics (ATTOGEN) questionnaire.

PubMed

Domeyer, Philip J; Aletras, Vassilis; Anagnostopoulos, Fotios; Katsari, Vasiliki; Niakas, Dimitris

2017-01-01

The use of generic medicines is a cost-effective policy, often dictated by fiscal restraints. To our knowledge, no fully validated tool exploring the students' knowledge and attitudes towards generic medicines exists. The aim of our study was to develop and validate a questionnaire exploring the knowledge and attitudes of M.Sc. in Health Care Management students and recent alumni's towards generic drugs in Greece. The development of the questionnaire was a result of literature review and pilot-testing of its preliminary versions to researchers and students. The final version of the questionnaire contains 18 items measuring the respondents' knowledge and attitude towards generic medicines on a 5-point Likert scale. Given the ordinal nature of the data, ordinal alpha and polychoric correlations were computed. The sample was randomly split into two halves. Exploratory factor analysis, performed in the first sample, was used for the creation of multi-item scales. Confirmatory factor analysis and Generalized Linear Latent and Mixed Model analysis (GLLAMM) with the use of the rating scale model were used in the second sample to assess goodness of fit. An assessment of internal consistency reliability, test-retest reliability, and construct validity was also performed. Among 1402 persons contacted, 986 persons completed our questionnaire (response rate = 70.3%). Overall Cronbach's alpha was 0.871. The conjoint use of exploratory and confirmatory factor analysis resulted in a six-scale model, which seemed to fit the data well. Five of the six scales, namely trust, drug quality, state audit, fiscal impact and drug substitution were found to be valid and reliable, while the knowledge scale suffered only from low inter-scale correlations and a ceiling effect. However, the subsequent confirmatory factor and GLLAMM analyses indicated a good fit of the model to the data. The ATTOGEN instrument proved to be a reliable and valid tool, suitable for assessing students' knowledge and attitudes towards generic medicines.

Health-related quality of life in young adult patients with rheumatoid arthritis in Iran: reliability and validity of the Persian translation of the PedsQL™ 4.0 Generic Core Scales Young Adult Version.

PubMed

Pakpour, Amir H; Zeidi, Isa Mohammadi; Hashemi, Fariba; Saffari, Mohsen; Burri, Andrea

2013-01-01

The objective of the present study was to determine the reliability and validity of the Persian translation of the Pediatric Quality of Life Inventory (PedsQL™) 4.0 Generic Core Scales Young Adult Version in an Iranian sample of young adult patients with rheumatoid arthritis (RA). One hundred ninety-seven young adult patients with RA completed the 23-item PedsQL™ and the 36-item Short-Form Health Survey (SF-36). Disease activity based on Disease Activity Score 28 was also measured. Internal consistency and test-retest reliability, as well as construct, discriminant, and convergent validity, were tested. Confirmatory factor analysis (CFA) was used to verify the original factor structure of the PedsQL™. Also, responsiveness to change in PedsQL™ scores over time was assessed. Cronbach's alpha coefficients ranged from α = 0.82 to α = 0.91. Test-retest reproducibility was satisfactory for all scales and the total scale score. The PedsQL proved good convergent validity with the SF-36. The PedsQL distinguished well between young adult patients and healthy young adults and also RA groups with different comorbidities. The CFA did not confirm the original four-factor model, instead, analyses revealed a best-fitting five-factor model for the PedsQL™ Young Adult Version. Repeated measures analysis of variance indicated that the PedsQL scale scores for young adults increased significantly over time. The Persian translation of the PedsQL™ 4.0 Generic Core Scales Young Adult Version demonstrated good psychometric properties in young adult patients with RA and can be recommended for the use in RA research in Iran.

Generic and therapeutic statin switches and disruptions in therapy.

PubMed

Chapman, Richard H; Benner, Joshua S; Girase, Prafulla; Benigno, Michael; Axelsen, Kirsten; Liu, Larry Z; Nichol, Michael B

2009-05-01

The study objective was to compare dose-equivalence, adherence and subsequent switch rates among patients recently switched from a branded to generic version of the same statin (generic substitution, GS) vs. those switched from branded statin to generic version of a different statin (therapeutic substitution, TS). In a retrospective cohort analysis among adult enrollees in over 90 US health plans, the authors identified adult patients who switched from a branded to generic statin from July-December 2006 (simvastatin became generic in June 2006). Patients were classified by type of statin switch: GS (e.g., branded simvastatin --> generic simvastatin), and TS (e.g., branded atorvastatin --> generic simvastatin). Demographic and clinical data were collected from claims before switch through 6 months follow-up. Separate outcomes of interest included proportion of patients that switched to a less potent daily dose, that switched back to previous branded statin after switch, and that were at least 80% adherent during the 6 months after initial switch. Significant predictors of each clinical outcome were identified using multivariable logistic regression models, adjusting for differences between groups in covariates and potential confounders. The 6-month TS (n = 3807) and GS (n = 40,165) groups were generally similar demographically. Compared to GS, TS patients were significantly more likely to be switched to a less potent dose (26.2% vs. 0.5%, adjusted odds ratio [AOR] in patients with high-potency index medication = 83.4, p < 0.0001); 33% less likely to be adherent in the 6 months after switch (67.7% vs. 75.9%, AOR in patients with no switch in first 6 months follow-up = 0.67, p < 0.0001); and four times more likely to switch back to previous branded statin (11.3% vs. 2.9%, AOR = 4.1, p < 0.0001). This study did not account for co-payment changes, lipid measurements, or changes in pill burden. While this study did not have data on why patients had TS (e.g., for cost or clinical reasons), TS was more likely to involve a subsequent disruption to statin therapy than GS. TS could potentially lead to adverse impacts on patients' outcomes, and should be studied further.

[PedsQL™ 4.0 Generic Core Infant Scales Parents Report for infants (ages 13-24 months). Linguistic validation from original US English version to Italian version].

PubMed

González-Melado, F J; Di Ciommo, V M; Di Pietro, M; Chiarini Testa, M B; Cutrera, R

2013-10-01

The purpose of this research was to show the translation and linguistic validation of the PedsQL™ 4.0 Generic Core Infant Scales Parents Report for Infants (ages 13-24 months) from its original English version to Italian language. The linguistic validation consists in three steps: a) different forward translations from the original US English instrument to Italian; this step includes the drawing of a "reconciliation" version (version 1); b) backward translations from the Italian reconciliation version to US English; c) patient testing: the second version of the questionnaire (obtained after the backward translations) has to be tested on a panel of a minimum of 5 respondents, throughout cognitive interviewing methodology, in order to obtain the final italian version of the PedsQL™ Parents Report for Infants (ages 13-24 months). In this report we summarize the third step of this process. To study the content validity, the applicability and comprehension of our questionnarie translation, we tested it through a qualitative methodology in a sample of parents whose children were hospitalized in Bambino Gesù Children's Hospital with two different kinds of interview: 4 parents responded to the questions posed through a "thinkaloud interview" and 3 parents responded to the questionnaire and to a "respondent debriefing" interview. We modified the main question of each section and also one of the possible answer in order to maintain the Italian translation that appeared in others PedsQL™. We did not modify the questions of each section because respondents expressed that are clearly comprehensible and easy to understand.

Psychometric properties of the Sinhala version of the PedsQL™ 4.0 Generic Core Scales in early adolescents in Sri Lanka

PubMed Central

2012-01-01

Background The concept Health related Quality of life (HRQOL) is increasingly recognized as an important health outcome measure in clinical and research fields. The present study attempted to evaluate the psychometric properties of the Sinhala version of the Pediatric Quality of Life Inventory™ 4.0 (PedsQL™ 4.0) Generic Core Scales among adolescents in Sri Lanka. Methods The original US PedsQL™ was translated into Sinhala and conceptually validated according to international guidelines. A cross-sectional study was conducted among 142 healthy school going adolescents (12-14 years), their parents (n = 120) and a group of adolescents with asthma who attended asthma clinics (n = 115). Reliability was assessed using Cronbach’s alpha and validity by examining scale structure, exploring inter-scale correlations and comparing across known groups (healthy vs. chronically ill). Results The PedsQL™ Sinhala version was found to be acceptable with minimal missing responses. All scales demonstrated satisfactory reliability. Cronbach’s alpha for the total scale scores was 0.85 for adolescent self-report while for the parent proxy-report for the healthy group it was 0.86. No floor effects were observed. Ceiling effects were noticed in self-report and parent proxy-report for the healthy group. Overall results of the multi trait scaling analysis confirmed the scale structure with 74% item-convergent validity, 88% item-discriminant validity and an overall scaling success of 72%. Moderate to high correlations were shown among the domains of teen self-report (Spearman rho = .37-.54) and between teen self-report and parent proxy-reports (Spearman rho = .41-.57). The PedsQL™ tool was able to discriminate between the quality of life in healthy adolescents and adolescents with asthma. Conclusion The findings support the reliability and validity of the Sinhala version of the PedsQL™ 4.0 Generic Core Scales as a generic instrument to measure HRQOL among early adolescents in Sri Lanka in a population setting. PMID:22947113

First Steps in the Development of the Inventario de Comportamiento de Estudio: The Spanish Version of the Study Behavior Inventory

ERIC Educational Resources Information Center

Bliss, Leonard B.; Vinay, Diana Maria Alejandra

2004-01-01

The Inventario de Comportamiento de Estudio (ICE), a Spanish version of the Study Behavior Inventory (SBI), was developed and tested using 594 undergraduate students at la Universidad de las Americas, in the state of Puebla, Mexico. A team of bilingual specialists was assembled to produce a translation that might be generic enough to be understood…

Measuring health-related quality of life in children with cancer living in Mainland China: feasibility, reliability and validity of the Chinese Mandarin version of PedsQL 4.0 Generic Core Scales and 3.0 Cancer Module.

PubMed

Ji, Yi; Chen, Siyuan; Li, Kai; Xiao, Nong; Yang, Xue; Zheng, Shan; Xiao, Xianmin

2011-11-23

The Pediatric Quality of Life Inventory (PedsQL) is widely used instrument to measure pediatric health-related quality of life (HRQOL) for children aged 2 to 18 years. The purpose of the current study was to investigate the feasibility, reliability and validity of the Chinese mandarin version of the PedsQL 4.0 Generic Core Scales and 3.0 Cancer Module in a group of Chinese children with cancer. The PedsQL 4.0 Genetic Core Scales and the PedsQL 3.0 Cancer Module were administered to children with cancer (aged 5-18 years) and parents of such children (aged 2-18 years). For comparison, a survey on a demographically group-matched sample of the general population with children (aged 5-18) and parents of children (aged 2-18 years) was conducted with the PedsQL 4.0 Genetic Core Scales. The minimal mean percentage of missing item responses (except the School Functioning scale) supported the feasibility of the PedsQL 4.0 Generic Core Scales and 3.0 Cancer Module for Chinese children with cancer. Most of the scales showed satisfactory reliability with Cronbach's α of exceeding 0.70, and all scales demonstrated sufficient test-retest reliability. Assessing the clinical validity of the questionnaires, statistically significant difference was found between healthy children and children with cancer, and between children on-treatment versus off-treatment ≥12 months. Positive significant correlations were observed between the scores of the PedsQL 4.0 Generic Core Scale and the PedsQL 3.0 Cancer Module. Exploratory factor analysis demonstrated sufficient factorial validity. Moderate to good agreement was found between child self- and parent proxy-reports. The findings support the feasibility, reliability and validity of the Chinese Mandarin version of PedsQL 4.0 Generic Core Scales and 3.0 Cancer Module in children with cancer living in mainland China.

Measuring health-related quality of life in children with cancer living in mainland China: feasibility, reliability and validity of the Chinese mandarin version of PedsQL 4.0 Generic Core Scales and 3.0 Cancer Module

PubMed Central

2011-01-01

Background The Pediatric Quality of Life Inventory (PedsQL) is widely used instrument to measure pediatric health-related quality of life (HRQOL) for children aged 2 to 18 years. The purpose of the current study was to investigate the feasibility, reliability and validity of the Chinese mandarin version of the PedsQL 4.0 Generic Core Scales and 3.0 Cancer Module in a group of Chinese children with cancer. Methods The PedsQL 4.0 Genetic Core Scales and the PedsQL 3.0 Cancer Module were administered to children with cancer (aged 5-18 years) and parents of such children (aged 2-18 years). For comparison, a survey on a demographically group-matched sample of the general population with children (aged 5-18) and parents of children (aged 2-18 years) was conducted with the PedsQL 4.0 Genetic Core Scales. Result The minimal mean percentage of missing item responses (except the School Functioning scale) supported the feasibility of the PedsQL 4.0 Generic Core Scales and 3.0 Cancer Module for Chinese children with cancer. Most of the scales showed satisfactory reliability with Cronbach's α of exceeding 0.70, and all scales demonstrated sufficient test-retest reliability. Assessing the clinical validity of the questionnaires, statistically significant difference was found between healthy children and children with cancer, and between children on-treatment versus off-treatment ≥12 months. Positive significant correlations were observed between the scores of the PedsQL 4.0 Generic Core Scale and the PedsQL 3.0 Cancer Module. Exploratory factor analysis demonstrated sufficient factorial validity. Moderate to good agreement was found between child self- and parent proxy-reports. Conclusion The findings support the feasibility, reliability and validity of the Chinese Mandarin version of PedsQL 4.0 Generic Core Scales and 3.0 Cancer Module in children with cancer living in mainland China. PMID:22111968

C++ Planning and Resource Reasoning (PARR) shell

NASA Technical Reports Server (NTRS)

Mcintyre, James; Tuchman, Alan; Mclean, David; Littlefield, Ronald

1994-01-01

This paper describes a generic, C++ version of the Planning and Resource Reasoning (PARR) shell which has been developed to supersede the C-based versions of PARR that are currently used to support AI planning and scheduling applications in flight operations centers at Goddard Space Flight Center. This new object-oriented version of PARR can be more easily customized to build a variety of planning and scheduling applications, and C++ PARR applications can be more easily ported to different environments. Genetic classes, constraints, strategies, and paradigms are described along with two types of PARR interfaces.

Impact of the trade-related aspects of intellectual property rights (TRIPS) agreement on India as a supplier of generic antiretrovirals.

PubMed

Babovic, Sonja; Wasan, Kishor M

2011-03-01

This is a commentary on how the trade-related aspects of intellectual property rights (TRIPS) agreement has impacted India as a supplier of generic antiretrovirals (ARVs). We provide a systematic review of the issues related to the TRIPS agreement that affects India. This includes discussion around (a) the legal landscape underpinning India as a supplier of generic ARVs; (b) supply of second-line ARVs; and (c) the future of generic drug production in India. The proclamation into force of TRIPS-compliant intellectual property law in India is likely to affect its position as a supplier of affordable ARVs, especially drugs brought to market after 2005. Currently, mechanisms exist for the generic production of almost all ARVs in India, including second-line drugs; however, the manufacture of these drugs by generic pharmaceutical companies may require additional market incentives. Compulsory licensing may emerge as an additional mechanism by which India can provide affordable versions of patented drugs to Least Developed Countries (LDCs). Copyright © 2010 Wiley-Liss, Inc.

Strategies That Delay Market Entry of Generic Drugs.

PubMed

Vokinger, Kerstin Noëlle; Kesselheim, Aaron S; Avorn, Jerry; Sarpatwari, Ameet

2017-11-01

Increasing prescription drug expenditures in the United States are primarily driven by high brand-name drug prices. Although generic competition helps lower drug prices, manufacturers of brand-name drugs often work to delay the availability of generic versions of their products. Strategies to forestall generic competition include patenting peripheral aspects of a drug or modified formulations that do not add clinical value, paying generic manufacturers to settle lawsuits challenging the validity of patents on brand-name drugs ("reverse payment" settlements), denying generic manufacturers access to drug samples necessary for bioequivalence testing, misusing risk evaluation and mitigation strategies, and filing citizen petitions with the US Food and Drug Administration (FDA). To address such tactics, the federal government can interpret existing patenting standards more strictly and promote certain types of patent challenges to ensure that patents are granted or upheld only for true innovations. Congress can enact pending legislation that would help discourage reverse payment settlements and compel brand-name manufacturers to share drug samples for bioequivalence testing. Finally, the FDA can provide earlier guidance on bioequivalence determinations for complex generic products and adopt the presumption that late-filed citizen petitions should be summarily rejected.

Psychometric properties of the Chinese version of the Pediatric Quality of Life Inventory 4.0 generic core scales.

PubMed

Hao, Yuantao; Tian, Qi; Lu, Yiyun; Chai, Yiming; Rao, Shaoqi

2010-10-01

The aim of this study was to evaluate the psychometric properties of the Chinese version of the Pediatric Quality of Life Inventory 4.0 (PedsQL 4.0) generic core scales. The standard procedure of cross-culture adaptation was used to develop the Chinese version PedsQL4.0. We enrolled 1583 healthy children and 1335 pediatric patients (aged from 5 to 18 years) and 325 proxies. The psychometric properties of the measure were evaluated. The subscales of physical functioning, social functioning and psychosocial showed alpha coefficients above 0.7 for self-report in healthy children and the total pediatric patients, and all coefficients were higher than 0.7 for proxy report for all subscales. There were higher correlations between items and hypothesized subscales than with other subscales. Healthy children reported higher scores than pediatric patients in all subscales. Confirmatory factor analysis showed that some of the indices of goodness of fit did not reach the standard of acceptable construct validity. Moderate to high correlations were found between self-reported and proxy-reported scores. The Chinese version PedsQL4.0 has acceptable psychometric properties except the construct validity tested by confirmatory factor analysis and the internal reliability for self-report in pediatric patients with migraine or Gilles and Tourette's syndrome.

Performance comparison of phenomenology-based features to generic features for false alarm reduction in UWB SAR imagery

NASA Astrophysics Data System (ADS)

Marble, Jay A.; Gorman, John D.

1999-08-01

A feature based approach is taken to reduce the occurrence of false alarms in foliage penetrating, ultra-wideband, synthetic aperture radar data. A set of 'generic' features is defined based on target size, shape, and pixel intensity. A second set of features is defined that contains generic features combined with features based on scattering phenomenology. Each set is combined using a quadratic polynomial discriminant (QPD), and performance is characterized by generating a receiver operating characteristic (ROC) curve. Results show that the feature set containing phenomenological features improves performance against both broadside and end-on targets. Performance against end-on targets, however, is especially pronounced.

Cisplatin-induced hyponatremia in malignancy: comparison between brand-name and generic formulation.

PubMed

Ochi, Nobuaki; Yamane, Hiromichi; Hotta, Katsuyuki; Fujii, Hiromi; Isozaki, Hideko; Honda, Yoshihiro; Yamagishi, Tomoko; Kubo, Toshio; Tanimoto, Mitsune; Kiura, Katsuyuki; Takigawa, Nagio

2014-01-01

Widespread use of generic drugs is considered to be indispensable if reductions in total health care costs are to be achieved, but the market share of such drugs remains low. In general, generic drugs have the same active ingredients as brand-name drugs, but this is not always the case. Thus, toxicity profiles may vary when brand-name and generic drugs are compared. We retrospectively investigated the incidence of hyponatremia in patients receiving brand-name cisplatin (CDDP) and a generic counterpart thereof. We reviewed the medical records of patients treated with brand-name CDDP (n=53) and a generic formulation (n=26), and compared the incidences of hyponatremia and renal toxicity. Toxicities were graded using the Common Terminology Criteria for Adverse Events, version 4.0. Differences between groups were evaluated using the Student's t-test, and the odds ratio for hyponatremia was estimated via logistic regression analysis. Serum creatinine levels after chemotherapy increased significantly in both the brand-name and generic CDDP groups; no significant difference was evident between the two groups. Hyponatremia of grade 3 or above developed in 30.7% of the generic CDDP group compared to 15.1% of the brand-name CDDP group (P=0.011). Multivariate analysis showed that the use of generic CDDP increased the incidence of hyponatremia (odds ratio =5.661, 95% confidence interval =1.403-22.839; P=0.015). Oncologists should be aware that use of a generic CDDP might be associated with more hyponatremia than would use of brand-name CDDP.

A population-based study of the use of selective serotonin reuptake inhibitors before and after introduction of generic equivalents.

PubMed

Bolton, James M; Dahl, Matthew; Sareen, Jitender; Enns, Murray W; Leslie, William D; Collins, David M; Alessi-Severini, Silvia

2012-04-01

Generic drugs are less expensive than their branded equivalents, but receive limited promotion. This study sought to examine how user rates of individual selective serotonin reuptake inhibitors (SSRIs) changed after the introduction of their generic equivalents. Administrative health and census data were used to examine the rates of use of all 6 SSRIs from 1996 to 2009 in the province of Manitoba (population of 1.2 million). The primary outcome measure was a comparison of the rates of use in the pre- and post-generic periods, using generalized estimating equations. Secondary analyses were stratified by specialty of physician prescriber. Escalating rates of use of branded SSRIs in the pre-generic period significantly decreased after generic versions became available (all Ps < 0.001). Incident use of sertraline and paroxetine continued to decrease throughout the post-generic period (1.5% and 1.9% quarterly decreasing rates, respectively). During the years when generic sertraline, fluoxetine, and fluvoxamine were available, their use declined while branded paroxetine and citalopram use continued to increase. Use of branded citalopram, sertraline, and paroxetine prescribed by general practitioners (GPs) increased at rates significantly higher than when prescribed by psychiatrists (all Ps < 0.001). The introduction of cheaper generic alternatives of SSRIs paradoxically resulted in their use diminishing rather than increasing. With the exception of escitalopram, branded SSRIs tended to be preferentially used, compared with available less expensive generic SSRIs. These patterns were more pronounced for prescriptions by GPs.

Modifications to risk-targeted seismic design maps for subduction and near-fault hazards

USGS Publications Warehouse

Liel, Abbie B.; Luco, Nicolas; Raghunandan, Meera; Champion, C.; Haukaas, Terje

2015-01-01

ASCE 7-10 introduced new seismic design maps that define risk-targeted ground motions such that buildings designed according to these maps will have 1% chance of collapse in 50 years. These maps were developed by iterative risk calculation, wherein a generic building collapse fragility curve is convolved with the U.S. Geological Survey hazard curve until target risk criteria are met. Recent research shows that this current approach may be unconservative at locations where the tectonic environment is much different than that used to develop the generic fragility curve. This study illustrates how risk-targeted ground motions at selected sites would change if generic building fragility curve and hazard assessment were modified to account for seismic risk from subduction earthquakes and near-fault pulses. The paper also explores the difficulties in implementing these changes.

Development and validation of a tool to assess knowledge and attitudes towards generic medicines among students in Greece: The ATtitude TOwards GENerics (ATTOGEN) questionnaire

PubMed Central

Katsari, Vasiliki; Niakas, Dimitris

2017-01-01

Introduction The use of generic medicines is a cost-effective policy, often dictated by fiscal restraints. To our knowledge, no fully validated tool exploring the students’ knowledge and attitudes towards generic medicines exists. The aim of our study was to develop and validate a questionnaire exploring the knowledge and attitudes of M.Sc. in Health Care Management students and recent alumni’s towards generic drugs in Greece. Materials and methods The development of the questionnaire was a result of literature review and pilot-testing of its preliminary versions to researchers and students. The final version of the questionnaire contains 18 items measuring the respondents’ knowledge and attitude towards generic medicines on a 5-point Likert scale. Given the ordinal nature of the data, ordinal alpha and polychoric correlations were computed. The sample was randomly split into two halves. Exploratory factor analysis, performed in the first sample, was used for the creation of multi-item scales. Confirmatory factor analysis and Generalized Linear Latent and Mixed Model analysis (GLLAMM) with the use of the rating scale model were used in the second sample to assess goodness of fit. An assessment of internal consistency reliability, test-retest reliability, and construct validity was also performed. Results Among 1402 persons contacted, 986 persons completed our questionnaire (response rate = 70.3%). Overall Cronbach’s alpha was 0.871. The conjoint use of exploratory and confirmatory factor analysis resulted in a six-scale model, which seemed to fit the data well. Five of the six scales, namely trust, drug quality, state audit, fiscal impact and drug substitution were found to be valid and reliable, while the knowledge scale suffered only from low inter-scale correlations and a ceiling effect. However, the subsequent confirmatory factor and GLLAMM analyses indicated a good fit of the model to the data. Conclusions The ATTOGEN instrument proved to be a reliable and valid tool, suitable for assessing students’ knowledge and attitudes towards generic medicines. PMID:29186163

The risks and costs of multiple-generic substitution of topiramate.

PubMed

Duh, M S; Paradis, P E; Latrémouille-Viau, D; Greenberg, P E; Lee, S P; Durkin, M B; Wan, G J; Rupnow, M F T; LeLorier, J

2009-06-16

To investigate clinical and economic consequences following generic substitution of one vs multiple generics of topiramate (Topamax; Ortho-McNeil Neurologics, Titusville, NJ). Medical and pharmacy claims data of Régie de l'Assurance-Maladie du Québec from January 2006 to October 2007 were used. Patients with epilepsy treated with topiramate were selected. An open-cohort design was used to classify the observation period into periods of brand, single-generic, and multiple-generic use. One-year generic-switch and switchback-to-brand rates were estimated using Kaplan-Meier methodology. Medical resource utilization and costs were compared among the three periods using multivariate regression analysis. In total, 948 patients were observed during 1,105 person-years of brand use, 233 person-years of single-generic use, and 92 person-years of multiple-generic use. A total of 23% of generic users received at least two different generic versions. Compared to brand use, multiple-generic use was associated with higher utilization of other prescription drugs (incidence rate ratio [IRR] = 1.27, 95% confidence interval [CI] = 1.24-1.31), higher hospitalization rates (0.48 vs 0.83 visit/person-year, IRR = 1.65, 95% CI = 1.28-2.13), and longer hospital stays (2.6 vs 3.9 days/person-year, IRR = 1.43, 95% CI = 1.27-1.60), but the effect was less pronounced in single-generic use (hospitalization: IRR = 1.08, 95% CI = 0.88-1.34, length of stay: IRR = 1.12, 95% CI = 1.03-1.23). The risk of head injury or fracture was nearly three times higher (hazard ratio = 2.84, 95% CI = 1.24-6.48) following a generic-to-generic switch compared to brand use. The total annualized health care cost per patient was higher in the multiple-generic than brand periods by C$1,716 (cost ratio = 1.21, p = 0.0420). Multiple-generic substitution of topiramate was significantly associated with negative outcomes, such as hospitalizations and injuries, and increased health care costs.

Super Cooled Large Droplet Analysis of Several Geometries Using LEWICE3D Version 3

NASA Technical Reports Server (NTRS)

Bidwell, Colin S.

2011-01-01

Super Cooled Large Droplet (SLD) collection efficiency calculations were performed for several geometries using the LEWICE3D Version 3 software. The computations were performed using the NASA Glenn Research Center SLD splashing model which has been incorporated into the LEWICE3D Version 3 software. Comparisons to experiment were made where available. The geometries included two straight wings, a swept 64A008 wing tip, two high lift geometries, and the generic commercial transport DLR-F4 wing body configuration. In general the LEWICE3D Version 3 computations compared well with the 2D LEWICE 3.2.2 results and with experimental data where available.

Usefulness of the WHOQOL-BREF questionnaire in assessing the quality of life of parents of children with asthma

PubMed Central

Roncada, Cristian; Dias, Caroline Pieta; Goecks, Suelen; Cidade, Simone Elenise Falcão; Pitrez, Paulo Márcio Condessa

2015-01-01

Objective:: To evaluate the quality of life (QOL) of parents of children with asthma and to analyze the internal consistency of the generic QOL tool World Health Organization Quality of Life, abbreviated version (WHOQOL-BREF). Methods:: We evaluated the QOL of parents of asthmatic and healthy children aged between 8 and 16, using the generic WHOQOL-BREF questionnaire. We also evaluated the internal consistency using Cronbach's alpha (αC), in order to determine whether the tool had good validity for the target audience. Results:: The study included 162 individuals with a mean age of 43.8±13.6 years, of which 104 were female (64.2%) and 128 were married (79.0%). When assessing the QOL, the group of parents of healthy children had higher scores than the group of parents of asthmatic children in the four areas evaluated by the questionnaire (Physical, Psychological Health, Social Relationships and Environment), indicating a better quality of life. Regarding the internal consistency of the WHOQOL-BREF, values of ˛C were 0.86 points for the group of parents of asthmatic children, and 0.88 for the group of parents of healthy children. Conclusions:: Parents of children with asthma have impaired quality of life due to their children's disease. Furthermore, the WHOQOL-BREF, even as a generic tool, showed to be practical and efficient to evaluate the quality of life of parents of asthmatic children. © 2015 Sociedade de Pediatria de São Paulo. Published by Elsevier Editora Ltda. All rights reserved. PMID:26137868

On the integrable elliptic cylindrical Kadomtsev-Petviashvili equation.

PubMed

Khusnutdinova, K R; Klein, C; Matveev, V B; Smirnov, A O

2013-03-01

There exist two versions of the Kadomtsev-Petviashvili (KP) equation, related to the Cartesian and cylindrical geometries of the waves. In this paper, we derive and study a new version, related to the elliptic cylindrical geometry. The derivation is given in the context of surface waves, but the derived equation is a universal integrable model applicable to generic weakly nonlinear weakly dispersive waves. We also show that there exist nontrivial transformations between all three versions of the KP equation associated with the physical problem formulation, and use them to obtain new classes of approximate solutions for water waves.

Measuring health-related quality of life in young adolescents: reliability and validity in the Norwegian version of the Pediatric Quality of Life Inventory 4.0 (PedsQL) generic core scales.

PubMed

Reinfjell, Trude; Diseth, Trond H; Veenstra, Marijke; Vikan, Arne

2006-09-14

Health-Related Quality of Life (HRQOL) studies concerning children and adolescents are a growing field of research. The Pediatric Quality of Life Inventory (PedsQL) is considered as a promising HRQOL instrument with the availability of age appropriate versions and parallel forms for both child and parents. The purpose of the current study was to evaluate the psychometric properties of the Norwegian translation of the Pediatric Quality of Life Inventory (PedsQL) 4.0 generic core scale in a sample of healthy young adolescents. A cross-sectional study of 425 healthy young adolescents and 237 of their caregivers participating as a proxy. Reliability was assessed by Cronbach's alpha. Construct validity was assessed using exploratory factor analysis and by exploring the intercorrelations between and among the four PedsQL subscales for adolescents and their parents. All the self-report scales and proxy-report scales showed satisfactory reliability with Cronbach's alpha varying between 0.77 and 0.88. Factor analysis showed results comparable with the original version, except for the Physical Health scale. On average, monotrait-multimethod correlations were higher than multitrait-multimethod correlations. Sex differences were noted on the emotional functioning subscale, girls reported lower HRQOL than boys. The Norwegian PedsQL is a valid and reliable generic pediatric health-related Quality of Life measurement that can be recommended for self-reports and proxy-reports for children in the age groups ranging from 13-15 years.

How Abbott’s Fenofibrate Franchise Avoided Generic Competition

PubMed Central

Downing, Nicholas S.; Ross, Joseph S.; Jackevicius, Cynthia A.; Krumholz, Harlan M.

2013-01-01

The ongoing debate concerning the efficacy of fenofibrate has overshadowed an important aspect of the drug’s history: Abbott, the maker of branded fenofibrate, has produced several bioequivalent reformulations, which dominate the market even though generic fenofibrate has been available for almost a decade. This continued use of branded formulations, which cost twice as much as generic versions of fenofibrate, imposes an annual cost of approximately $700 million on our healthcare system. Abbott maintained its dominance of the fenofibrate market, in part, through a complex switching strategy involving the sequential launch of branded reformulations that had not been shown to be superior to the first generation product and patent litigation that delayed the approval of generic formulations. The small differences in dose of the newer branded formulations prevented substitution with generics of older generation products. As soon as direct generic competition seemed likely at the new dose level where substitution would be allowed, Abbott would launch another reformulation and the cycle would repeat. Our objective, using the fenofibrate example, is to describe how current policy can allow pharmaceutical companies to maintain market share using reformulations of branded medications without demonstrating the superiority of next generation products. PMID:22493409

Avoidance of generic competition by Abbott Laboratories' fenofibrate franchise.

PubMed

Downing, Nicholas S; Ross, Joseph S; Jackevicius, Cynthia A; Krumholz, Harlan M

2012-05-14

The ongoing debate concerning the efficacy of fenofibrate has overshadowed an important aspect of the drug's history: Abbott Laboratories, the maker of branded fenofibrate, has produced several bioequivalent reformulations that dominate the market, although generic fenofibrate has been available for almost a decade. This continued use of branded formulations, which cost twice as much as generic versions of fenofibrate, imposes an annual cost of approximately $700 million on the US health care system. Abbott Laboratories maintained its dominance of the fenofibrate market in part through a complex switching strategy involving the sequential launch of branded reformulations that had not been shown to be superior to the first-generation product and patent litigation that delayed the approval of generic formulations. The small differences in dose of the newer branded formulations prevented their substitution with generics of older-generation products. As soon as direct generic competition seemed likely at the new dose level, where substitution would be allowed, Abbott would launch another reformulation, and the cycle would repeat. Based on the fenofibrate example, our objective is to describe how current policy can allow pharmaceutical companies to maintain market share using reformulations of branded medications, without demonstrating the superiority of next-generation products.

Generic Substitution of Orphan Drugs for the Treatment of Rare Diseases: Exploring the Potential Challenges.

PubMed

Di Paolo, Antonello; Arrigoni, Elena

2018-03-01

Generic drugs are important components of measures introduced by healthcare regulatory authorities to reduce treatment costs. In most patients and conditions the switch from a branded drug to its generic counterpart is performed with no major complications. However, evidence from complex diseases suggests that generic substitution requires careful evaluation in some settings and that current bioequivalence criteria may not always be adequate for establishing the interchangeability of branded and generic products. Rare diseases, also called orphan diseases, are a group of heterogeneous diseases that share important characteristics: in addition to their scarcity, most are severe, chronic, highly debilitating, and often present in early childhood. Finding a treatment for a rare disease is challenging. Thanks to incentives that encourage research and development programs in rare diseases, several orphan drugs are currently available. The elevated cost of orphan drugs is a highly debated issue and a cause of limited access to treatment for many patients. As patent protection and the exclusivity period of several orphan drugs will expire soon, generic versions of orphan drugs should reach the market shortly, with great expectations about their impact on the economic burden of rare diseases. However, consistent with other complex diseases, generic substitution may require thoughtful considerations and may be even contraindicated in some rare conditions. This article provides an overview of rare disease characteristics, reviews reports of problematic generic substitution, and discusses why generic substitution of orphan drugs may be challenging and should be undertaken carefully in rare disease patients.

Flu and People with Asthma

MedlinePlus

... available as a generic version or under the trade name Tamiflu®) or peramivir (trade name Rapivab®) are the two antiviral drugs that ... asthma. People with asthma should not use zanamivir (trade name Relenza®), a different antiviral drug, because there ...

A wakeup call to the prevention field: are prevention programs for substance use effective for girls?

PubMed

Kumpfer, Karol L; Smith, Paula; Summerhays, Julia Franklin

2008-07-01

Substance misuse in adolescent girls has increased dramatically since 1992. This article reviews trends in use rates and etiological theories tested by gender that suggest that family protective factors have more influence on girls. Next, a literature review reveals that few prevention programs have published their outcomes by gender or developed gender-specific programs. Nationwide community coalition results found positive effects on boys but increased drug use in young girls. The most effective programs are family focused targeting family bonding, supervision, and communication. Recent gender-specific prevention programs with positive results address stress, depression, social assertiveness, and body image. The authors recommend additional research testing programs by gender and also gender-specific versus generic versions of evidence-based programs to determine how to improve prevention program effectiveness for girls.

Baseline assessment of WHO's target for both availability and affordability of essential medicines to treat non-communicable diseases.

PubMed

Ewen, Margaret; Zweekhorst, Marjolein; Regeer, Barbara; Laing, Richard

2017-01-01

WHO has set a voluntary target of 80% availability of affordable essential medicines, including generics, to treat major non-communicable diseases (NCDs), in the public and private sectors of countries by 2025. We undertook a secondary analysis of data from 30 surveys in low- and middle-income countries, conducted from 2008-2015 using the World Health Organization (WHO)/Health Action International (HAI) medicine availability and price survey methodology, to establish a baseline for this target. Data for 49 medicines (lowest priced generics and originator brands) to treat cardiovascular diseases (CVD), diabetes, chronic obstructive pulmonary diseases (COPD) and central nervous system (CNS) conditions were analysed to determine their availability in healthcare facilities and pharmacies, their affordability for those on low incomes (based on median patient prices of each medicine), and the percentage of medicines that were both available and affordable. Affordability was expressed as the number of days' wages of the lowest-paid unskilled government worker needed to purchase 30 days' supply using standard treatment regimens. Paying more than 1 days' wages was considered unaffordable. In low-income countries, 15.2% and 18.9% of lowest-priced generics met WHO's target in the public and private sectors, respectively, and 2.6% and 5.2% of originator brands. In lower-middle income countries, 23.8% and 23.2% of lowest priced generics, and 0.8% and 1.4% of originator brands, met the target in the public and private sectors, respectively. In upper-middle income countries, the situation was better for generics but still suboptimal as 36.0% and 39.4% met the target in public and private sectors, respectively. For originator brands in upper-middle income countries, none reached the target in the public sector and 13.7% in the private sector. Across the therapeutic groups for lowest priced generics, CVD medicines in low-income countries (11.9%), and CNS medicines in lower-middle (10.2%) and upper-middle income countries (33.3%), were least available and affordable in the public sector. In the private sector for lowest priced generics, CNS medicines were least available and affordable in all three country income groups (11.4%, 5.8% and 29.3% in low-, lower-middle and upper-middle income countries respectively). This data, which can act as a baseline for the WHO target, shows low availability and/or poor affordability is resulting in few essential NCD medicines meeting the target in low- and middle-income countries. In the era of Sustainable Development Goals, and as countries work to achieve Universal Health Coverage, increased commitments are needed by governments to improve the situation through the development of evidence-informed, nationally-contextualised interventions, with regular monitoring of NCD medicine availability, patient prices and affordability.

Should anti-tobacco media messages be culturally targeted for Indigenous populations? A systematic review and narrative synthesis.

PubMed

Gould, Gillian Sandra; McEwen, Andy; Watters, Tracey; Clough, Alan R; van der Zwan, Rick

2013-07-01

To summarise published empirical research on culturally targeted anti-tobacco media messages for Indigenous or First Nations people and examine the evidence for the effectiveness of targeted and non-targeted campaigns. Studies were sought describing mass media and new media interventions for tobacco control or smoking cessation in Indigenous or First Nations populations. Studies of any design were included reporting outcomes of media-based interventions including: cognitions, awareness, recall, intention to quit and quit rates. Then, 2 reviewers independently applied inclusion criteria, which were met by 21 (5.8%) of the studies found. One author extracted data with crosschecking by a second. Both independently assessed papers using Scottish Intercollegiate Guidelines Network (SIGN; quantitative studies) and Daly et al (qualitative studies). A total of 21 studies were found (4 level 1 randomised controlled trials (RCTs), 11 level 2 studies and 6 qualitative studies) and combined with narrative synthesis. Eight evaluated anti-tobacco TV or radio campaigns; two assessed US websites; three New Zealand studies examined mobile phone interventions; five evaluated print media; three evaluated a CD-ROM, a video and an edutainment intervention. Although Indigenous people had good recall of generic anti-tobacco messages, culturally targeted messages were preferred. New Zealand Maori may be less responsive to holistic targeted campaigns, despite their additional benefits, compared to generic fear campaigns. Culturally targeted internet or mobile phone messages appear to be as effective in American Indians and Maori as generic messages in the general population. There is little research comparing the effect of culturally targeted versus generic messages with similar message content in Indigenous people.

Patients’ beliefs about generic medicines in Malaysia

PubMed Central

Wong, Zhi Y.; Hassali, Mohamed A.; Alrasheedy, Alian A.; Saleem, Fahad; Yahaya, Abdul H.; Aljadhey, Hisham

2014-01-01

Background: Acceptance of generic medicines by patients is an essential factor given that they are the end users of these medicines. In fact, adequate knowledge and positive perceptions are prerequisite to patients’ acceptance and use of generic medicines. Objective: To assess the current belief and views of patients about generic medicines in Malaysia. Method: This was a self-administered questionnaire-based study. The study was conducted with patients visiting outpatient pharmacy department at a tertiary care hospital in Malaysia. The Malaysian version of Generic Medicines Scale (GMS) was used. The GMS consists of two subscales: efficacy and similarity of generic medicines to original brand medicines. The efficacy subscale consists of 10 items while the similarity subscale consists of 6 items. The responses to the items were framed as a five-point Likert scale (1=strongly disagree to 5=strongly agree). Results: A total of 202 out of 300 patients participated in the study, giving a response rate of 67.3%. In this study, only 49% of them (n=99) knew the term ‘generic medicine’. Moreover, only 53.5% of the respondents (n=108) believed that the efficacy of generic medicines was the same as original brand medicines. In terms of quality, only 44% of the respondents (n=89) disagreed that generic medicines were of a lower quality. About one third (n=65, 32.2%) believed that generic medicines were cheaper because they were less efficacious. In terms of side effects, 44.5% of the respondents (n=90) believed that generic medicines had the same side effect profile as original brand medicines. Conclusions: The study finding showed that almost half of the respondents had negative belief in generic medicines. Similarly, many patients were not aware of the similarities and differences between generic and original brand medicines. Therefore, there is a need to provide patients with adequate information about generic medicines. PMID:25580171

Target prices for mass production of tyrosine kinase inhibitors for global cancer treatment

PubMed Central

Hill, Andrew; Gotham, Dzintars; Fortunak, Joseph; Meldrum, Jonathan; Erbacher, Isabelle; Martin, Manuel; Shoman, Haitham; Levi, Jacob; Powderly, William G; Bower, Mark

2016-01-01

Objective To calculate sustainable generic prices for 4 tyrosine kinase inhibitors (TKIs). Background TKIs have proven survival benefits in the treatment of several cancers, including chronic myeloid leukaemia, breast, liver, renal and lung cancer. However, current high prices are a barrier to treatment. Mass production of low-cost generic antiretrovirals has led to over 13 million people being on HIV/AIDS treatment worldwide. This analysis estimates target prices for generic TKIs, assuming similar methods of mass production. Methods Four TKIs with patent expiry dates in the next 5 years were selected for analysis: imatinib, erlotinib, lapatinib and sorafenib. Chemistry, dosing, published data on per-kilogram pricing for commercial transactions of active pharmaceutical ingredient (API), and quotes from manufacturers were used to estimate costs of production. Analysis included costs of excipients, formulation, packaging, shipping and a 50% profit margin. Target prices were compared with current prices. Global numbers of patients eligible for treatment with each TKI were estimated. Results API costs per kg were $347–$746 for imatinib, $2470 for erlotinib, $4671 for lapatinib, and $3000 for sorafenib. Basing on annual dose requirements, costs of formulation/packaging and a 50% profit margin, target generic prices per person-year were $128–$216 for imatinib, $240 for erlotinib, $1450 for sorafenib, and $4020 for lapatinib. Over 1 million people would be newly eligible to start treatment with these TKIs annually. Conclusions Mass generic production of several TKIs could achieve treatment prices in the range of $128–$4020 per person-year, versus current US prices of $75161–$139 138. Generic TKIs could allow significant savings and scaling-up of treatment globally, for over 1 million eligible patients. PMID:26817636

Generic detection of poleroviruses using an RT-PCR assay targeting the RdRp coding sequence.

PubMed

Lotos, Leonidas; Efthimiou, Konstantinos; Maliogka, Varvara I; Katis, Nikolaos I

2014-03-01

In this study a two-step RT-PCR assay was developed for the generic detection of poleroviruses. The RdRp coding region was selected as the primers' target, since it differs significantly from that of other members in the family Luteoviridae and its sequence can be more informative than other regions in the viral genome. Species specific RT-PCR assays targeting the same region were also developed for the detection of the six most widespread poleroviral species (Beet mild yellowing virus, Beet western yellows virus, Cucurbit aphid-borne virus, Carrot red leaf virus, Potato leafroll virus and Turnip yellows virus) in Greece and the collection of isolates. These isolates along with other characterized ones were used for the evaluation of the generic PCR's detection range. The developed assay efficiently amplified a 593bp RdRp fragment from 46 isolates of 10 different Polerovirus species. Phylogenetic analysis using the generic PCR's amplicon sequence showed that although it cannot accurately infer evolutionary relationships within the genus it can differentiate poleroviruses at the species level. Overall, the described generic assay could be applied for the reliable detection of Polerovirus infections and, in combination with the specific PCRs, for the identification of new and uncharacterized species in the genus. Copyright © 2013 Elsevier B.V. All rights reserved.

Knowledge, attitudes, and practices of community pharmacists on generic medicines in Qatar.

PubMed

Awaisu, Ahmed; Kheir, Nadir; Ibrahim, Mohamed Izham Mohamed; El-Hajj, Maguy; Hazi, Huda; Khudair, Nada; Barazi, Raja

2014-04-01

The practice of generic medicines prescribing, dispensing and substitution in developing countries has been controversial among healthcare professionals, particularly due to issues on quality, safety and efficacy. These controversies are as a result of inter-country differences in policies and laws as well as individualized knowledge and attitudes of pharmacists pertaining to generic medicines. This study primarily aims to assess the knowledge, attitudes, and practices of community pharmacists in Qatar towards generic medicines. Community pharmacy settings throughout the State of Qatar. A cross-sectional study using a pretested paper-based survey was conducted among a random sample of community pharmacists in Qatar. The data were analyzed using IBM-SPSS(®) version 20. Both descriptive and inferential statistical analyses were applied. Knowledge, attitudes, and practices of generic medicines pertaining to regulatory standards, safety, efficacy, quality, and future policies. Results A total of 160 surveys were distributed to community pharmacists of which 118 were returned (response rate, 74 %). The mean total score of generic medicines knowledge among the pharmacists was 6.8 ± 1.6 (maximum possible score was 10). Years of practice as well as place of obtaining academic degree did not influence knowledge score. Approximately 72 % of the pharmacists supported generic substitution for brand name drugs in all cases where a generic medicine is available and the majority (93 %) agreed that pharmacists should be given generic substitution right. Nearly 61 % of the pharmacists considered lack of proven bioequivalence to original brands as an important barrier for selecting generic medicines and 55 % rated "lack of policy for directing the practice of generic medicine" as an important barrier. In order to enhance the quality use of and to promote the practice of generic medicines in Qatar, an educational program should be implemented. A national generic medicine policy and guidelines are warranted in the State of Qatar.

Item analysis using Rasch models confirms that the Danish versions of the DISABKIDS® chronic-generic and diabetes-specific modules are valid and reliable.

PubMed

Nielsen, Julie Bøjstrup; Kyvsgaard, Julie Nyholm; Sildorf, Stine Møller; Kreiner, Svend; Svensson, Jannet

2017-03-01

Type 1 Diabetes (T1D) has a negative impact on psychological and overall well-being. Screening for Health-related Quality of Life (HrQoL) and addressing HrQoL issues in the clinic leads to improved well-being and metabolic outcomes. The aim of this study was to translate the generic and diabetes-specific validated multinational DISABKIDS® questionnaires into Danish, and then determine their validity and reliability. The questionnaires were translated using a validated translation procedure and completed by 99 children and adolescents from our diabetes-department; all diagnosed with T1D and were aged between 8 and 18 years old. The Rasch and the graphical log linear Rasch model (GLLRM) were used to determine validity. Monte Carlo methods and Cronbach's α were used to confirm reliability. The data did not fit a pure Rasch model but did fit a GLLRM when item six in the independence scale is excluded. The six subscales measure different aspects of HrQoL indicating that all the subscales are necessary. The questionnaire shows local dependency between items and differential item functioning (DIF). Therefore age, gender, and glycated hemoglobin (HbA1c) levels must be taken into account when comparing HrQoL between groups. The Danish versions of the DISABKIDS® chronic-generic and diabetes-specific modules provide valid and objective measurements with adequate reliability. These Danish versions are useful tools for evaluating HrQoL in Danish patients with T1D. However, guidelines on how to manage DIF and local independence will be required, and item six should be rephrased.

Comparative analysis of the cost and effectiveness of generic and brand-name antibiotics: the case of uncomplicated urinary tract infection.

PubMed

Lin, Yu-Shiuan; Jan, I-Shiow; Cheng, Shou-Hsia

2017-03-01

Generic medications used for chronic diseases are beneficial in containing healthcare costs and improving drug accessibility. However, the effects of generic drugs in acute and severe illness remain controversial. This study aims to investigate treatment costs and outcomes of generic antibiotics prescribed for adults with a urinary tract infection in outpatient settings. The data source was the Longitudinal Health Insurance Database of Taiwan. We included outpatients aged 20 years and above with a urinary tract infection who required one oral antibiotic for which brand-name and generic products were simultaneously available. Drug cost and overall healthcare expense of the index consultation, healthcare cost during a 42-day follow-up period, and treatment failure rates were the main dependent variables. Data were compared between brand-name and generic users from the entire cohort and a propensity score-matched samples. Results from the entire cohort and propensity score-matched samples were similar. Daily antibiotic cost was significantly lower among generic users than brand-name users. Significant lower total drug claims of the index consultation only existed in patients receiving the investigated antibiotics, while the drug price between brand-name and generic versions were relatively large (e.g., >50%). The overall healthcare cost of the index consultation, healthcare expenditure during a 42-day follow-up period, and treatment failure rates were similar between the two groups. Compared with those treated with brand-name antibiotics, outpatients who received generic antibiotics had equivalent treatment outcomes with lower drug costs. Generic antibiotics are effective and worthy of adoption among outpatients with simple infections indicating oral antibiotic treatment. Copyright © 2016 John Wiley & Sons, Ltd. Copyright © 2016 John Wiley & Sons, Ltd.

A randomized crossover study comparing the antiplatelet effect of plavix versus generic clopidogrel.

PubMed

Sambu, Nalyaka; Radhakrishnan, Ashwin; Curzen, Nick

2012-12-01

Clopidogrel exists in different salt formulations. All published data that have demonstrated its beneficial effect are based entirely on the hydrogen sulphate salt contained in the branded product Plavix, which had US sales of $6.1 billion in 2010 alone. A number of cheaper generic versions of clopidogrel are increasingly being used in Europe as an alternative to Plavix, mainly for cost reasons. However, there is insufficient evidence to show that their pharmacodynamic effect is equivalent to Plavix. This prospective study investigated whether there is any significant difference in the antiplatelet effect of Plavix versus generic clopidogrel hydrochloride in healthy male volunteers. All participants received loading and maintenance doses of both drugs, in a crossover manner, separated by a 2-week washout period. Adenosine diphosphate (ADP)-induced platelet reactivity was measured using short thrombelastography at multiple timepoints. The results showed interindividual heterogeneity in responses to clopidogrel but no significant difference in ADP-induced platelet reactivity between Plavix versus generic clopidogrel hydrochloride. Our findings suggest comparable inhibition of ADP-induced platelet reactivity with Plavix and generic clopidogrel hydrochloride. This observation is particularly pertinent at a time when the patent for Plavix is expected to expire in the near future leading to the large-scale switch to cheaper generic preparations.

Clinical tolerability of generic versus brand beta blockers in heart failure with reduced left ventricular ejection fraction: a retrospective cohort from heart failure clinic.

PubMed

Chanchai, Rattanachai; Kanjanavanit, Rungsrit; Leemasawat, Krit; Amarittakomol, Anong; Topaiboon, Paleerat; Phrommintikul, Arintaya

2018-01-01

Background: Beta-blockers have been shown to decrease mortality and morbidity in heart failure with reduced ejection fraction (HFrEF) patients. However, the side effects are also dose-related, leading to the underdosing. Cost constraint may be one of the limitations of appropriate beta-blocker use; this can be improved with generic drugs. However, the effects in real life practice have not been investigated. Methods and results: This study aimed to compare the efficacy and safety of generic and brand beta-blockers in HFrEF patients. We performed a retrospective cohort analysis in HFrEF patients who received either generic or brand beta-blocker in Chiang Mai Heart Failure Clinic. The primary endpoint was the proportion of patients who received at least 50% target dose of beta-blocker between generic and brand beta-blockers. Adverse events were secondary endpoints. 217 patients (119 and 98 patients received generic and brand beta-blocker, respectively) were enrolled. There were no differences between groups regarding age, gender, etiology of heart failure, New York Heart Association (NYHA) functional class, left ventricular ejection fraction (LVEF), rate of receiving angiotensin converting enzyme inhibitor (ACEI), angiotensin recepter blocker (ARB), or spironolactone. Patients receiving brand beta-blockers had lower resting heart rate at baseline (74.9 and 84.2 bpm, p  = .001). Rate of achieved 50% target dose and target daily dose did not differ between groups (40.4 versus 44.5% and 48.0 versus 55.0%, p  > .05, respectively). Rate of side effects was not different between groups (32.3 versus 29.5%, p  > .05) and the most common side effect was hypotension. Conclusion: This study demonstrated that beta-blocker tolerability was comparable between brand and generic formulations. Generic or brand beta-blockers should be prescribed to HFrEF patients who have no contraindications.

Clinical tolerability of generic versus brand beta blockers in heart failure with reduced left ventricular ejection fraction: a retrospective cohort from heart failure clinic

PubMed Central

Chanchai, Rattanachai; Kanjanavanit, Rungsrit; Leemasawat, Krit; Amarittakomol, Anong; Topaiboon, Paleerat; Phrommintikul, Arintaya

2018-01-01

Abstract Background: Beta-blockers have been shown to decrease mortality and morbidity in heart failure with reduced ejection fraction (HFrEF) patients. However, the side effects are also dose-related, leading to the underdosing. Cost constraint may be one of the limitations of appropriate beta-blocker use; this can be improved with generic drugs. However, the effects in real life practice have not been investigated. Methods and results: This study aimed to compare the efficacy and safety of generic and brand beta-blockers in HFrEF patients. We performed a retrospective cohort analysis in HFrEF patients who received either generic or brand beta-blocker in Chiang Mai Heart Failure Clinic. The primary endpoint was the proportion of patients who received at least 50% target dose of beta-blocker between generic and brand beta-blockers. Adverse events were secondary endpoints. 217 patients (119 and 98 patients received generic and brand beta-blocker, respectively) were enrolled. There were no differences between groups regarding age, gender, etiology of heart failure, New York Heart Association (NYHA) functional class, left ventricular ejection fraction (LVEF), rate of receiving angiotensin converting enzyme inhibitor (ACEI), angiotensin recepter blocker (ARB), or spironolactone. Patients receiving brand beta-blockers had lower resting heart rate at baseline (74.9 and 84.2 bpm, p = .001). Rate of achieved 50% target dose and target daily dose did not differ between groups (40.4 versus 44.5% and 48.0 versus 55.0%, p > .05, respectively). Rate of side effects was not different between groups (32.3 versus 29.5%, p > .05) and the most common side effect was hypotension. Conclusion: This study demonstrated that beta-blocker tolerability was comparable between brand and generic formulations. Generic or brand beta-blockers should be prescribed to HFrEF patients who have no contraindications. PMID:29379674

Michelin Tire Company Workplace Literacy Curriculum.

ERIC Educational Resources Information Center

Alabama State Dept. of Education, Montgomery.

This packet provides generic versions of curriculum developed for the Michelin Tire Corporation workplace literacy program, specifically the mathematics portion. Altered material included in the packet protects proprietary information; some lessons include lines that take the place of deleted information. Other companies are recommended to use…

Generic Protocol for the Verification of Ballast Water Treatment Technology. Version 5.1

DTIC Science & Technology

2010-09-01

the Protocol ..................................................................................... 2 1.4 Verification Testing Process ...Volumes, Containers and Processing .................................................................38 Table 10. Recommendation for Water...or persistent distortion of a measurement process that causes errors in one direction. Challenge Water: Water supplied to a treatment system under

TIM Version 3.0 beta Technical Description and User Guide - Appendix D - Avian Data to Support Generic and Custom Species

EPA Pesticide Factsheets

TIM Appendix D summarizes avian census studies from pesticide registrant submissions and literature. The purpose of this review is to identify avian species that are representative of those that commonly visit agricultural fields.

Physicochemical Characterization of Iron Carbohydrate Colloid Drug Products.

PubMed

Zou, Peng; Tyner, Katherine; Raw, Andre; Lee, Sau

2017-09-01

Iron carbohydrate colloid drug products are intravenously administered to patients with chronic kidney disease for the treatment of iron deficiency anemia. Physicochemical characterization of iron colloids is critical to establish pharmaceutical equivalence between an innovator iron colloid product and generic version. The purpose of this review is to summarize literature-reported techniques for physicochemical characterization of iron carbohydrate colloid drug products. The mechanisms, reported testing results, and common technical pitfalls for individual characterization test are discussed. A better understanding of the physicochemical characterization techniques will facilitate generic iron carbohydrate colloid product development, accelerate products to market, and ensure iron carbohydrate colloid product quality.

Baseline assessment of WHO’s target for both availability and affordability of essential medicines to treat non-communicable diseases

PubMed Central

Ewen, Margaret; Zweekhorst, Marjolein; Regeer, Barbara; Laing, Richard

2017-01-01

Background WHO has set a voluntary target of 80% availability of affordable essential medicines, including generics, to treat major non-communicable diseases (NCDs), in the public and private sectors of countries by 2025. We undertook a secondary analysis of data from 30 surveys in low- and middle-income countries, conducted from 2008–2015 using the World Health Organization (WHO)/Health Action International (HAI) medicine availability and price survey methodology, to establish a baseline for this target. Methods Data for 49 medicines (lowest priced generics and originator brands) to treat cardiovascular diseases (CVD), diabetes, chronic obstructive pulmonary diseases (COPD) and central nervous system (CNS) conditions were analysed to determine their availability in healthcare facilities and pharmacies, their affordability for those on low incomes (based on median patient prices of each medicine), and the percentage of medicines that were both available and affordable. Affordability was expressed as the number of days’ wages of the lowest-paid unskilled government worker needed to purchase 30 days’ supply using standard treatment regimens. Paying more than 1 days’ wages was considered unaffordable. Findings In low-income countries, 15.2% and 18.9% of lowest-priced generics met WHO’s target in the public and private sectors, respectively, and 2.6% and 5.2% of originator brands. In lower-middle income countries, 23.8% and 23.2% of lowest priced generics, and 0.8% and 1.4% of originator brands, met the target in the public and private sectors, respectively. In upper-middle income countries, the situation was better for generics but still suboptimal as 36.0% and 39.4% met the target in public and private sectors, respectively. For originator brands in upper-middle income countries, none reached the target in the public sector and 13.7% in the private sector. Across the therapeutic groups for lowest priced generics, CVD medicines in low-income countries (11.9%), and CNS medicines in lower-middle (10.2%) and upper-middle income countries (33.3%), were least available and affordable in the public sector. In the private sector for lowest priced generics, CNS medicines were least available and affordable in all three country income groups (11.4%, 5.8% and 29.3% in low-, lower-middle and upper-middle income countries respectively). Interpretation This data, which can act as a baseline for the WHO target, shows low availability and/or poor affordability is resulting in few essential NCD medicines meeting the target in low- and middle-income countries. In the era of Sustainable Development Goals, and as countries work to achieve Universal Health Coverage, increased commitments are needed by governments to improve the situation through the development of evidence-informed, nationally-contextualised interventions, with regular monitoring of NCD medicine availability, patient prices and affordability. PMID:28170413

Improvements to the adaptive maneuvering logic program

NASA Technical Reports Server (NTRS)

Burgin, George H.

1986-01-01

The Adaptive Maneuvering Logic (AML) computer program simulates close-in, one-on-one air-to-air combat between two fighter aircraft. Three important improvements are described. First, the previously available versions of AML were examined for their suitability as a baseline program. The selected program was then revised to eliminate some programming bugs which were uncovered over the years. A listing of this baseline program is included. Second, the equations governing the motion of the aircraft were completely revised. This resulted in a model with substantially higher fidelity than the original equations of motion provided. It also completely eliminated the over-the-top problem, which occurred in the older versions when the AML-driven aircraft attempted a vertical or near vertical loop. Third, the requirements for a versatile generic, yet realistic, aircraft model were studied and implemented in the program. The report contains detailed tables which make the generic aircraft to be either a modern, high performance aircraft, an older high performance aircraft, or a previous generation jet fighter.

Querying Archetype-Based Electronic Health Records Using Hadoop and Dewey Encoding of openEHR Models.

PubMed

Sundvall, Erik; Wei-Kleiner, Fang; Freire, Sergio M; Lambrix, Patrick

2017-01-01

Archetype-based Electronic Health Record (EHR) systems using generic reference models from e.g. openEHR, ISO 13606 or CIMI should be easy to update and reconfigure with new types (or versions) of data models or entries, ideally with very limited programming or manual database tweaking. Exploratory research (e.g. epidemiology) leading to ad-hoc querying on a population-wide scale can be a challenge in such environments. This publication describes implementation and test of an archetype-aware Dewey encoding optimization that can be used to produce such systems in environments supporting relational operations, e.g. RDBMs and distributed map-reduce frameworks like Hadoop. Initial testing was done using a nine-node 2.2 GHz quad-core Hadoop cluster querying a dataset consisting of targeted extracts from 4+ million real patient EHRs, query results with sub-minute response time were obtained.

Demand-side policies to encourage the use of generic medicines: an overview.

PubMed

Dylst, Pieter; Vulto, Arnold; Simoens, Steven

2013-02-01

Demand-side policies to encourage the use of generic medicines are important to increase their use. A plethora of different demand-side policies has already been initiated by European governments, thereby targeting physicians, pharmacists and patients. This review aims to give an overview of the different demand-side policies which governments have at their disposal and to evaluate their impact on the use of generic medicines. Positive knowledge and perceptions of physicians, pharmacists and patients of generic medicines are necessary prerequisites to increase the use of generic medicines and governments should initiate policies to achieve this. These policies should be combined with policies to increase their financial responsibility to the healthcare system and policies to facilitate the prescribing of generic medicines.

SNOT-22: psychometric properties and cross-cultural adaptation into the Portuguese language spoken in Brazil.

PubMed

Caminha, Guilherme Pilla; Melo Junior, José Tavares de; Hopkins, Claire; Pizzichini, Emilio; Pizzichini, Marcia Margaret Menezes

2012-12-01

Rhinosinusitis is a highly prevalent disease and a major cause of high medical costs. It has been proven to have an impact on the quality of life through generic health-related quality of life assessments. However, generic instruments may not be able to factor in the effects of interventions and treatments. SNOT-22 is a major disease-specific instrument to assess quality of life for patients with rhinosinusitis. Nevertheless, there is still no validated SNOT-22 version in our country. Cross-cultural adaptation of the SNOT-22 into Brazilian Portuguese and assessment of its psychometric properties. The Brazilian version of the SNOT-22 was developed according to international guidelines and was broken down into nine stages: 1) Preparation 2) Translation 3) Reconciliation 4) Back-translation 5) Comparison 6) Evaluation by the author of the SNOT-22 7) Revision by committee of experts 8) Cognitive debriefing 9) Final version. Second phase: prospective study consisting of a verification of the psychometric properties, by analyzing internal consistency and test-retest reliability. Cultural adaptation showed adequate understanding, acceptability and psychometric properties. We followed the recommended steps for the cultural adaptation of the SNOT-22 into Portuguese language, producing a tool for the assessment of patients with sinonasal disorders of clinical importance and for scientific studies.

Hemiparesis and Epilepsy Are Associated With Worse Reported Health Status Following Unilateral Stroke in Children

PubMed Central

Smith, Sabrina E.; Vargas, Gray; Cucchiara, Andrew J.; Zelonis, Sarah J.; Beslow, Lauren A.

2015-01-01

BACKGROUND Perinatal and childhood stroke result in neurological impairment in the majority of survivors, but less is known about patient and parent perception of function following stroke in children. Our aim was to characterize parent-proxy and child-reported health status in children following unilateral arterial ischemic stroke or intraparenchymal hemorrhage. METHODS Fifty-nine children 2–18 years (30 girls, 29 boys) with unilateral arterial ischemic stroke or spontaneous intraparenchymal hemorrhage at least 6 months before evaluation were enrolled from a single center. The PedsQL version 4.0 Generic Short Form and PedsQL version 3.0 Cerebral Palsy Module were administered to childhood stroke subjects and parents. Generic PedsQL Inventory scores were compared between children with stroke and published data from healthy children. Reported health status scores for children with varying degrees of hemiparesis were compared. RESULTS Children with stroke had lower reported health status scores on the Generic PedsQL Inventory than healthy children. Children with moderate-severe hemiparesis had worse scores than children without hemiparesis on several measures of the Cerebral Palsy Module as reported by both parents and children. The parents of children with epilepsy reported worse scores on several measures compared with children without epilepsy, and the parent scores were lower on several measures for children with lower intelligence quotients. Agreement between parent and child scores was better on the Cerebral Palsy Module than on the Generic Inventory. CONCLUSIONS Children with stroke have worse reported health status than healthy controls. Degree of hemiparesis, epilepsy, and lower intelligence quotient affect reported health status on some measures. Agreement between parent-proxy and child scores ranges from slight to good which suggests that both provide useful information. PMID:25559938

Hemiparesis and epilepsy are associated with worse reported health status following unilateral stroke in children.

PubMed

Smith, Sabrina E; Vargas, Gray; Cucchiara, Andrew J; Zelonis, Sarah J; Beslow, Lauren A

2015-04-01

Perinatal and childhood stroke result in neurological impairment in the majority of survivors, but less is known about patient and parent perception of function following stroke in children. Our aim was to characterize parent-proxy and child-reported health status in children following unilateral arterial ischemic stroke or intraparenchymal hemorrhage. Fifty-nine children 2-18 years (30 girls, 29 boys) with unilateral arterial ischemic stroke or spontaneous intraparenchymal hemorrhage at least 6 months before evaluation were enrolled from a single center. The PedsQL version 4.0 Generic Short Form and PedsQL version 3.0 Cerebral Palsy Module were administered to childhood stroke subjects and parents. Generic PedsQL Inventory scores were compared between children with stroke and published data from healthy children. Reported health status scores for children with varying degrees of hemiparesis were compared. Children with stroke had lower reported health status scores on the Generic PedsQL Inventory than healthy children. Children with moderate-severe hemiparesis had worse scores than children without hemiparesis on several measures of the Cerebral Palsy Module as reported by both parents and children. The parents of children with epilepsy reported worse scores on several measures compared with children without epilepsy, and the parent scores were lower on several measures for children with lower intelligence quotients. Agreement between parent and child scores was better on the Cerebral Palsy Module than on the Generic Inventory. Children with stroke have worse reported health status than healthy controls. Degree of hemiparesis, epilepsy, and lower intelligence quotient affect reported health status on some measures. Agreement between parent-proxy and child scores ranges from slight to good which suggests that both provide useful information. Copyright © 2015 Elsevier Inc. All rights reserved.

Development and psychometric evaluation of a Catalan self- and interviewer-administered version of the Pediatric Quality of Life Inventory version 4.0.

PubMed

Huguet, Anna; Miró, Jordi

2008-01-01

The purposes of this study were to develop and to assess the psychometric properties of a Catalan self- and interviewer-administered version of the Pediatric Quality of Life Inventory Generic Core Scales (PedsQL) with a sample of schoolchildren, and to examine the equivalence between both versions. 511 schoolchildren aged between 9 and 17 years old participated in the study. In addition to completing a Catalan self-administered version of the PedsQL, each child was interviewed individually. Confirmatory factor analysis did not support the original Varni's proposal. Instead, a short 12-item version was derived. The higher-order scales for both versions were internally consistent. Moreover, relationships between ratings of children's quality of life were generally significant; both versions were also found to be related with another measure of quality of life supporting their validity. A new administration form for the PedsQL is presented in this study. The psychometric properties of both self- and interviewer-administered short 12-item versions are reassuring albeit with a few areas of improvement. Further studies are needed to investigate whether self- and interviewer-administered versions can really be considered to be comparable.

Target prices for mass production of tyrosine kinase inhibitors for global cancer treatment.

PubMed

Hill, Andrew; Gotham, Dzintars; Fortunak, Joseph; Meldrum, Jonathan; Erbacher, Isabelle; Martin, Manuel; Shoman, Haitham; Levi, Jacob; Powderly, William G; Bower, Mark

2016-01-27

To calculate sustainable generic prices for 4 tyrosine kinase inhibitors (TKIs). TKIs have proven survival benefits in the treatment of several cancers, including chronic myeloid leukaemia, breast, liver, renal and lung cancer. However, current high prices are a barrier to treatment. Mass production of low-cost generic antiretrovirals has led to over 13 million people being on HIV/AIDS treatment worldwide. This analysis estimates target prices for generic TKIs, assuming similar methods of mass production. Four TKIs with patent expiry dates in the next 5 years were selected for analysis: imatinib, erlotinib, lapatinib and sorafenib. Chemistry, dosing, published data on per-kilogram pricing for commercial transactions of active pharmaceutical ingredient (API), and quotes from manufacturers were used to estimate costs of production. Analysis included costs of excipients, formulation, packaging, shipping and a 50% profit margin. Target prices were compared with current prices. Global numbers of patients eligible for treatment with each TKI were estimated. API costs per kg were $347-$746 for imatinib, $2470 for erlotinib, $4671 for lapatinib, and $3000 for sorafenib. Basing on annual dose requirements, costs of formulation/packaging and a 50% profit margin, target generic prices per person-year were $128-$216 for imatinib, $240 for erlotinib, $1450 for sorafenib, and $4020 for lapatinib. Over 1 million people would be newly eligible to start treatment with these TKIs annually. Mass generic production of several TKIs could achieve treatment prices in the range of $128-$4020 per person-year, versus current US prices of $75161-$139,138. Generic TKIs could allow significant savings and scaling-up of treatment globally, for over 1 million eligible patients. 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/

Can we ensure the safe use of known human teratogens? Introduction of generic isotretinoin in the US as an example.

PubMed

Honein, Margaret A; Moore, Cynthia A; Erickson, J David

2004-01-01

The prescription of known teratogenic medications requires a careful balance between allowing women access to medications that they might need and avoiding unnecessary exposure to these medications during pregnancy because of their devastating fetal effects. Isotretinoin, a potent human teratogen, is of particular concern because of its widespread use among reproductive-aged women and the dramatic increase in use from 1992 through 2000. A revised risk management system was implemented in 2002 because of concerns about the continued occurrence of isotretinoin-exposed pregnancies. However, the recent approval of three generic versions of isotretinoin in the US has further complicated risk management and raises concerns that use might increase further if the lower cost of generics serves to increase accessibility. There are now four separate isotretinoin risk management systems in the US, each with its own distinct packaging, though the requirements for and substance of each are identical. Some additional concrete steps could be taken to minimise any unnecessary use of isotretinoin and help allow an adequate assessment of the current risk management systems. In addition to being familiar with and following all aspects of the current risk management system, physicians could choose to limit the use of isotretinoin to those who meet the labelled indications in order to reduce the number of exposed pregnancies. All four companies currently marketing isotretinoin in the US could jointly and voluntarily establish a consolidated, mandatory registration and follow-up of all women of reproductive potential who receive an isotretinoin prescription. Mandatory registration has many challenges, but it could allow a clear accounting of the total number of women for whom follow-up information is and is not available. Although the companies cannot be legally compelled to use a consolidated approach, the use of a single registry for the originator's product and all generic brands would allow identification of duplicates and also avoid the confusion that is introduced by providing materials that not only look different, but also have different addresses, contact information and names for participation in follow-up surveys. This is particularly important because women might take more than one version of isotretinoin during a single course of therapy or might receive a different programme's materials from their doctor than from the pharmacy. Though the introduction of generic versions of isotretinoin further complicates risk management, the companies marketing isotretinoin have an opportunity to work together to demonstrate their commitment to both limit the occurrence of exposed pregnancies and conduct a meaningful evaluation of the occurrence of pregnancies exposed to isotretinoin.

A Generic Protocol for Intracellular Expression of Recombinant Proteins in Bacillus subtilis.

PubMed

Phan, Trang; Huynh, Phuong; Truong, Tuom; Nguyen, Hoang

2017-01-01

Bacillus subtilis (B. subtilis) is a potential and attractive host for the production of recombinant proteins. Different expression systems for B. subtilis have been developed recently, and various target proteins have been recombinantly synthesized and purified using this host. In this chapter, we introduce a generic protocol to express a recombinant protein in B. subtilis. It includes protocols for (1) using our typical expression vector (plasmid pHT254) to introduce a target gene, (2) transformation of the target vector into B. subtilis, and (3) evaluation of the actual expression of a recombinant protein.

Algorithm To Architecture Mapping Model (ATAMM) multicomputer operating system functional specification

NASA Technical Reports Server (NTRS)

Mielke, R.; Stoughton, J.; Som, S.; Obando, R.; Malekpour, M.; Mandala, B.

1990-01-01

A functional description of the ATAMM Multicomputer Operating System is presented. ATAMM (Algorithm to Architecture Mapping Model) is a marked graph model which describes the implementation of large grained, decomposed algorithms on data flow architectures. AMOS, the ATAMM Multicomputer Operating System, is an operating system which implements the ATAMM rules. A first generation version of AMOS which was developed for the Advanced Development Module (ADM) is described. A second generation version of AMOS being developed for the Generic VHSIC Spaceborne Computer (GVSC) is also presented.

CRUNCH_PARALLEL

DOE Office of Scientific and Technical Information (OSTI.GOV)

Shumaker, Dana E.; Steefel, Carl I.

The code CRUNCH_PARALLEL is a parallel version of the CRUNCH code. CRUNCH code version 2.0 was previously released by LLNL, (UCRL-CODE-200063). Crunch is a general purpose reactive transport code developed by Carl Steefel and Yabusake (Steefel Yabsaki 1996). The code handles non-isothermal transport and reaction in one, two, and three dimensions. The reaction algorithm is generic in form, handling an arbitrary number of aqueous and surface complexation as well as mineral dissolution/precipitation. A standardized database is used containing thermodynamic and kinetic data. The code includes advective, dispersive, and diffusive transport.

Neural Computation and the Computational Theory of Cognition

ERIC Educational Resources Information Center

Piccinini, Gualtiero; Bahar, Sonya

2013-01-01

We begin by distinguishing computationalism from a number of other theses that are sometimes conflated with it. We also distinguish between several important kinds of computation: computation in a generic sense, digital computation, and analog computation. Then, we defend a weak version of computationalism--neural processes are computations in the…

9 CFR 317.4 - Labeling approval.

Code of Federal Regulations, 2011 CFR

2011-01-01

... Devices, except for generically approved labeling authorized for use in § 317.5(b). The management of the... indication of final color, as specified in § 317.2. FSIS will accept sketches that are hand drawn, computer generated or other reasonable facsimiles that clearly reflect and project the final version of the labeling...

Generic and oral quality of life is affected by oral mucosal diseases

PubMed Central

2012-01-01

Background The generic and oral health-related quality of life (QoL) has provided opportunity for investigation of the interrelations among generic health, oral health, and related outcomes. The purpose of this study was to identify the generic and oral QoL in the patients with oral mucosal disease (OMD). Methods Five hundred and thirty-eight OMDs were recruited in this study. The instruments applied were Chinese version of the 36-item short form health survey (SF-36) and the short-form of Oral Health Impact Profile (OHIP-14). Results The mean score of sum OHIP-14 was significantly higher in the patients with OMD (10.81 ± 9.01) compared with those in the healthy subjects (HS) (6.55 ± 6.73) (p < 0.001, Mann-Whitney U test). 56.51% of the OMD patients and 12.94% of the HS reported at least one oral negative impact (p < 0.001, Chi-square test). The overall mean score of SF-36 was significantly lower in the patients with OMD (74.54 ± 12.77) compared with those in the HS (77.97 ± 12.39) (p = 0.021, t-test). Conclusions Administration of specific and generic questionnaires of QoL can provide us a detailed picture of the impact of OMDs on patients, and both generic and oral QoL were impaired in the patients with OMD. PMID:22225834

MAROC, a generic photomultiplier readout chip

NASA Astrophysics Data System (ADS)

Blin, S.; Barrillon, P.; de La Taille, C.

2010-12-01

The MAROC ASICs family is dedicated to the readout of 64-channel Multi Anode PMT and similar detectors. Its main roles are to correct the gain spread of MAPMT channels thanks to an individual variable gain preamplifier and to discriminate the input signals (from 50fC i.e 1/3 photo-electron) in order to produce 64 trigger outputs. A multiplexed analog charge output is also available with a dynamic range around 10 pe ( ~ 1.6 pC) and a 12 bit Wilkinson ADC is embedded. Three versions of this chip have been submitted. MAROC 2 is the production version for the ATLAS luminometer and MAROC3 is a version with lower dissipation and significant improvements concerning the charge (30 pe: ~ 5 pC) and trigger (discrimination from 10fC). This third version showed very good characteristics that are presented here.

Deeply discounted medications: Implications of generic prescription drug wars.

PubMed

Czechowski, Jessica L; Tjia, Jennifer; Triller, Darren M

2010-01-01

To describe the history of generic prescription pricing programs at major pharmacy chains and their potential implications on prescribing, quality of care, and patient safety. Publicly available generic prescription discount program drug lists as of May 1, 2009. Fierce competition among major pharmacy chains such as Walgreens, CVS, and Walmart has led to a generic prescription pricing war with unclear public health implications. Introduced in 2006, currently 7 of the 10 largest pharmacy chains advertise a version of a deeply discounted medication (DDM) program, accounting for more than 25,000 locations nationally. By early 2008, almost 70 million Americans had used these programs. Although DDM programs lower drug costs for many patients, DDM formularies include potentially ineffective or harmful medications, have the potential to influence physician prescribing behavior, and may impair pharmacists' ability to review complete drug-dispensing records. DDMs are widespread but have the potential for unintended consequences on patients, providers, and the health care system. A systematic review of DDMs needs to evaluate the clinical, economic, and system-level implications of such programs.

Achieving Proficiency Goals through Competency Guidelines.

ERIC Educational Resources Information Center

Bartz, Walter H.; Strasheim, Lorraine

The Indiana Foreign Language Generic Competencies for Levels 1-4 define language-learning outcomes in terms of communicative competencies within generic cultural contexts. Nine cultural contexts (travel/transportation, the "world" of the target language, school and education, family and home, leisure time, meeting personal needs, world…

Measuring health-related quality of life in Hungarian children with heart disease: psychometric properties of the Hungarian version of the Pediatric Quality of Life Inventory 4.0 Generic Core Scales and the Cardiac Module.

PubMed

Berkes, Andrea; Pataki, István; Kiss, Mariann; Kemény, Csilla; Kardos, László; Varni, James W; Mogyorósy, Gábor

2010-01-28

The aim of the study was to investigate the psychometric properties of the Hungarian version of the Pediatric Quality of Life Inventory (PedsQL) Generic Core Scales and Cardiac Module. The PedsQL 4.0 Generic Core Scales and the PedsQL 3.0 Cardiac Module was administered to 254 caregivers of children (aged 2-18 years) and to 195 children (aged 5-18 years) at a pediatric cardiology outpatient unit. A postal survey on a demographically group-matched sample of the general population with 525 caregivers of children (aged 2-18 years) and 373 children (aged 5-18 years) was conducted with the PedsQL 4.0 Generic Core Scale. Responses were described, compared over subgroups of subjects, and were used to assess practical utility, distributional coverage, construct validity, internal consistency, and inter-reporter agreement of the instrument. The moderate scale-level mean percentage of missing item responses (range 1.8-2.3%) supported the feasibility of the Generic Core Scales for general Hungarian children. Minimal to moderate ceiling effects and no floor effects were found on the Generic Core Scales. We observed stronger ceiling than floor effects in the Cardiac Module. Most of the scales showed satisfactory reliability with Cronbach's alpha estimates exceeding 0.70. Generally, moderate to good agreement was found between self- and parent proxy-reports in the patient and in the comparison group (intraclass correlation coefficient range 0.52-0.77), but remarkably low agreement in the perceived physical appearance subscale in the age group 5-7 years (0.18) and for the treatment II scale (problems on taking heart medicine) scale of the Cardiac Module in children aged 8-12 years (0.39). Assessing the construct validity of the questionnaires, statistically significant difference was found between the patient group and the comparison group only in the Physical Functioning Scale scores (p = 0.003) of the child self-report component, and in Physical (p = 0.022), Emotional, (p = 0.017), Psychosocial Summary (p = 0.019) scores and in the total HRQoL (health-related quality of life) scale score (p = 0.034) for parent proxy-report. The findings generally support the feasibility, reliability and validity of the Hungarian translation of the PedsQL 4.0 Generic Core Scales and the PedsQL 3.0 Cardiac Module in Hungarian children with heart disease.

Comparison between utility of the Thai Pediatric Quality of Life Inventory 4.0 Generic Core Scales and 3.0 Cerebral Palsy Module.

PubMed

Tantilipikorn, Pinailug; Watter, Pauline; Prasertsukdee, Saipin

2013-03-01

Health-related quality of life (HRQOL) is increasingly being considered in the management of patients with various conditions. HRQOL instruments can be broadly classified as generic or disease-specific measures. Several generic HRQOL instruments in different languages have been developed for paediatric populations including the Pediatric Quality of Life Inventory 4.0 (PedsQL 4.0) Generic Core Scale. This tool and a condition-specific tool, PedsQL 3.0 Cerebral Palsy (CP) Module, are widely used in children with CP. No psychometric properties have been reported for Thai PedsQL 4.0. Therefore, this study aimed to explore the psychometric properties of the Thai version of the PedsQL 4.0 Generic Core Scales and compare these with the values for the Thai PedsQL 3.0 CP Module reported previously. Thai PedsQL 4.0 Generic Core Scales and the PedsQL 3.0 CP Module were completed, respectively, by children with CP and their parents or caregivers twice within 2-4 weeks. Respondents were 97 parents or caregivers and 54 children. Minimal missing data were found in most scales. Acceptable internal consistency was supported, except for Emotional, Social, and School Functioning. Intraclass correlation coefficients for parent-proxy report and self-report were good to excellent (0.625-0.849). The feasibility and reliability of the Thai PedsQL 4.0 Generic Core Scales were supported. The Thai PedsQL 3.0 CP Module showed higher values for the psychometric properties. Low-to-good correlations were found among the scales between the PedsQL 4.0 Generic Core Scales and the 3.0 CP Module. Both instruments could be used to measure HRQOL for children with CP, and may provide different information.

Evaluating community pharmacists' perspectives and practices concerning generic medicines substitution in Saudi Arabia: A cross-sectional study.

PubMed

Alkhuzaee, Fahad S; Almalki, Hamdan M; Attar, Ammar Y; Althubiani, Shoeab I; Almuallim, Wassam Ali; Cheema, Ejaz; Hadi, Muhammad Abdul

2016-12-01

To assess the community pharmacists' knowledge, attitude, perception and current practices towards generic medicines substitution in Saudi Arabia. A cross-sectional study was conducted between February and March 2016 in the Makkah region, Saudi Arabia. A 25-item, structured, validated, pilot-tested and self-completed questionnaire was used to achieve study objectives. A 4-step systematic sampling technique was used to recruit community pharmacists. Data were analysed using SPSS version 20. Of 128 community pharmacists approached, 121 participated in the study (response rate=95%). Majority of the participants (n=108; 89.3%) had graduated from Egypt, were working as staff pharmacists (n=85; 70%) and had BPharm degree (97; 80.2%). Only 26 (22%) of the participants correctly answered all knowledge questions accurately. No statistically significant difference in total knowledge score was observed across different sociodemographic characteristics of participants (all P>0.05).Two-thirds of the respondents (83; 68.2%) supported the use of generic substitution. Medicines cost and patients' request were the most commonly cited reasons for performing generic substitution. Country of graduation (P=0.01) and number of years of practicing in Saudi Arabia (P=0.02) was associated with the pharmacists' support towards generic substitution. The community pharmacists had clear knowledge deficits about generic medicines and their substitution which may partly explain low consumption of generic medicines in Saudi Arabia. Healthcare policy makers need to improve awareness about the safety and efficacy of generic medicines and promote their use in order to cut down cost of medicines and overall healthcare expenditure. Copyright © 2016 Elsevier Ireland Ltd. All rights reserved.

Brand versus generic dispensing trend for ciprofloxacin 500 mg, levofloxacin 500 mg, and moxifloxacin 400 mg (oral dosage forms) among pharmacies of Karachi, Pakistan.

PubMed

Zehra, Fatima; Naqvi, Atta Abbas; Tasneem, Sumbul; Ahmad, Rizwan; Ahmad, Niyaz; Shamsi, Adnan Zia; Asghar, Naqiya Ali; Khan, Ghufran Ullah

2017-01-01

Pakistan spends 0.7% of its gross domestic product on health. The public sector health-care system provides services to 22% of population thus paving the way for a dominant private sector. Patients in Pakistan mostly pay their medical expenses directly, and 64% of the health expenditures are borne by the household. Expenditure on medicine constitutes 43% of the total household expenditure. A quantitative cross-sectional study was conducted in Karachi, Pakistan, for a month. It was aimed at gathering response from different pharmacies to understand the brand versus generic dispensing trend of ciprofloxacin 500 mg, levofloxacin 500 mg, and moxifloxacin 400 mg oral dosage forms. The study employed convenience sampling and used a survey checklist. The data gathered was entered in SPSS version 22. The mean price per tablet for ciprofloxacin brand and generic was reported at Pakistani Rupees (PKR) 48.44 and PKR 26.85, respectively. The trend for dispensing ciprofloxacin highlighted a split in the market between brand (51%) and generic (49%). For levofloxacin brand and generic, the price per tablet was reported at PKR 36.50 and PKR 36.15 respectively, and despite same price, the market was dominated by generic levofloxacin (92%). Due to a price difference between brand and generic moxifloxacin, i.e., PKR 129.44 and PKR 71.91, respectively, the market was mostly occupied by the generic form (75%). Pricing mechanism must be revisited, and the authorities should take stern actions against any illegitimate price hike. The surging burden of drug expenditure on poorer sections of the society must be addressed by the government on an urgent basis.

Generation and context memory.

PubMed

Mulligan, Neil W; Lozito, Jeffrey P; Rosner, Zachary A

2006-07-01

Generation enhances memory for occurrence but may not enhance other aspects of memory. The present study further delineates the negative generation effect in context memory reported in N. W. Mulligan (2004). First, the negative generation effect occurred for perceptual attributes of the target item (its color and font) but not for extratarget aspects of context (location and background color). Second, nonvisual generation tasks with either semantic or nonsemantic generation rules (antonym and rhyme generation, respectively) produced the same pattern of results. In contrast, a visual (or data-driven) generation task (letter transposition) did not disrupt context memory for color. Third, generating nonwords produced no effect on item memory but persisted in producing a negative effect on context memory for target attributes, implying that (a) the negative generation effect in context memory is not mediated by semantic encoding, and (b) the negative effect on context memory can be dissociated from the positive effect on item memory. The results are interpreted in terms of the processing account of generation. The original, perceptual-conceptual version of this account is too narrow, but a modified processing account, based on a more generic visual versus nonvisual processing distinction, accommodates the results. Copyright 2006 APA, all rights reserved.

ATR-FTIR characterization of generic brand-named and counterfeit sildenafil- and tadalafil-based tablets found on the Brazilian market.

PubMed

Coelho Neto, José; Lisboa, Fernanda L C

2017-07-01

Viagra and Cialis are among the most counterfeited medicines in many parts of the world, including Brazil. Despite the many studies that have been made regarding discrimination between genuine and counterfeit samples, most published works do not contemplate generic and similar versions of these medicines and also do not explore excipients/adjuvants contributions when characterizing genuine and suspected samples. In this study, we present our findings in exploring ATR-FTIR spectral profiles for characterizing both genuine and questioned samples of several generic and brand-name sildenafil- and tadalafil-based tablets available on the Brazilian market, including Viagra and Cialis. Multi-component spectral matching (deconvolution), objective visual comparison and correlation tests were used during analysis. Besides from allowing simple and quick identification of counterfeits, results obtained evidenced the strong spectral similarities between generic and brand-named tablets employing the same active ingredient and the indistinguishability between samples produced by the same manufacturer, generic or not. For all sildenafil-based and some tadalafil-based tablets tested, differentiation between samples from different manufacturers, attributed to slight variations in excipients/adjuvants proportions, was achieved, thus allowing the possibility of tracing an unknown/unidentified tablet back to a specific manufacturer. Copyright © 2017 The Chartered Society of Forensic Sciences. Published by Elsevier B.V. All rights reserved.

77 FR 75110 - Agency Information Collection Activities: Proposed Collection; Comment Request-Generic Clearance...

Federal Register 2010, 2011, 2012, 2013, 2014

2012-12-19

...: Proposed Collection; Comment Request--Generic Clearance To Conduct Formative Research AGENCY: Food and.... This information collection will conduct research in support of FNS' goal of delivering science-based... target audience, FNS plans to conduct data collections that involve formative research including focus...

Effects of generic versus non-generic feedback on motor learning in children.

PubMed

Chiviacowsky, Suzete; Drews, Ricardo

2014-01-01

Non-generic feedback refers to a specific event and implies that performance is malleable, while generic feedback implies that task performance reflects an inherent ability. The present study examined the influences of generic versus non-generic feedback on motor performance and learning in 10-year-old children. In the first experiment, using soccer ball kicking at a target as a task, providing participants with generic feedback resulted in worse performance than providing non-generic feedback, after both groups received negative feedback. The second experiment measured more permanent effects. Results of a retention test, performed one day after practicing a throwing task, showed that participants who received non-generic feedback during practice outperformed the generic feedback group, after receiving a negative feedback statement. The findings demonstrate the importance of the wording of feedback. Even though different positive feedback statements may not have an immediate influence on performance, they can affect performance, and presumably individuals' motivation, when performance is (purportedly) poor. Feedback implying that performance is malleable, rather than due to an inherent ability, seems to have the potential to inoculate learners against setbacks--a situation frequently encountered in the context of motor performance and learning.

Effects of Generic versus Non-Generic Feedback on Motor Learning in Children

PubMed Central

Chiviacowsky, Suzete; Drews, Ricardo

2014-01-01

Non-generic feedback refers to a specific event and implies that performance is malleable, while generic feedback implies that task performance reflects an inherent ability. The present study examined the influences of generic versus non-generic feedback on motor performance and learning in 10-year-old children. In the first experiment, using soccer ball kicking at a target as a task, providing participants with generic feedback resulted in worse performance than providing non-generic feedback, after both groups received negative feedback. The second experiment measured more permanent effects. Results of a retention test, performed one day after practicing a throwing task, showed that participants who received non-generic feedback during practice outperformed the generic feedback group, after receiving a negative feedback statement. The findings demonstrate the importance of the wording of feedback. Even though different positive feedback statements may not have an immediate influence on performance, they can affect performance, and presumably individuals' motivation, when performance is (purportedly) poor. Feedback implying that performance is malleable, rather than due to an inherent ability, seems to have the potential to inoculate learners against setbacks – a situation frequently encountered in the context of motor performance and learning. PMID:24523947

The first three minutes - 1990 version. [of early universe after Big Bang

NASA Technical Reports Server (NTRS)

Schramm, David N.

1991-01-01

The present state of understanding of what occurred in the universe's first three minutes is reviewed. Emphasis is on the events that lead to potentially observable consequences and that are model-independent or at least generic to broad classes of models. Inflation, phase transitions, dark matter, and nucleosynthesis are summarized.

From stable to unstable anomaly-induced inflation

NASA Astrophysics Data System (ADS)

Netto, Tibério de Paula; Pelinson, Ana M.; Shapiro, Ilya L.; Starobinsky, Alexei A.

2016-10-01

Quantum effects derived through conformal anomaly lead to an inflationary model that can be either stable or unstable. The unstable version requires a large dimensionless coefficient of about 5× {10}^8 in front of the {R}^2 term that results in the inflationary regime in the R+{R}^2 ("Starobinsky") model being a generic intermediate attractor. In this case the non-local terms in the effective action are practically irrelevant, and there is a `graceful exit' to a low curvature matter-like dominated stage driven by high-frequency oscillations of R - scalarons, which later decay to pairs of all particles and antiparticles, with the amount of primordial scalar (density) perturbations required by observations. The stable version is a genuine generic attractor, so there is no exit from it. We discuss a possible transition from stable to unstable phases of inflation. It is shown that this transition is automatic if the sharp cut-off approximation is assumed for quantum corrections in the period of transition. Furthermore, we describe two different quantum mechanisms that may provide a required large {R}^2-term in the transition period.

Prescription for fairness: a new approach to tort liability of brand-name and generic drug manufacturers.

PubMed

Rostron, Allen

2011-02-01

Over the past two decades, courts have consistently ruled that the manufacturer of a brand-name prescription drug cannot be liable for injuries suffered by those taking generic imitations of its product. This meant that a patient injured by a generic drug could have no remedy at all because in many instances the generic drug manufacturer would escape liability on the ground that it did not produce any information on which the patient's doctor relied. It was a perplexing dilemma. The generic drug manufacturer made the product that the plaintiff received, the brand-name manufacturer produced all of the information the patient's doctor saw, and neither manufacturer could be held liable even if each acted negligently. The California Court of Appeal recently issued a stunning decision in which it concluded that a brand-name drug manufacturer could be liable to a plaintiff who took a generic version of its product. The reaction to the decision has been overwhelmingly negative. Commentators have condemned the decision as one of the worst rulings made by any court in recent years. Judges around the country have dismissed it as a misguided aberration from the otherwise strong judicial consensus on the issue. Although the decision has been the subject of scathing criticism, this Article argues that the California court's ruling actually represents the first time that a court has properly examined this issue. In addition, the Article points out some weaknesses in the California court's reasoning and proposes a novel general framework for analyzing the liability of brand-name and generic drug manufacturers.

A randomized, double-blind, cross-over, phase IV trial of oros-methylphenidate (CONCERTA(®)) and generic novo-methylphenidate ER-C (NOVO-generic).

PubMed

Fallu, Angelo; Dabouz, Farida; Furtado, Melissa; Anand, Leena; Katzman, Martin A

2016-08-01

Attention-deficit/hyperactivity disorder (ADHD) is a common neurobehavioral disorder with onset during childhood. Multiple aspects of a child's development are hindered, in both home and school settings, with negative impacts on social, emotional, and cognitive functioning. If left untreated, ADHD is commonly associated with poor academic achievement and low occupational status, as well as increased risk of substance abuse and delinquency. The objective of this study was to evaluate adult ADHD subject reported outcomes when switched from a stable dose of CONCERTA(®) to the same dose of generic Novo-methylphenidate ER-C(®). Randomized, double-blind, cross-over, phase IV trial consisted of two phases in which participants with a primary diagnosis of ADHD were randomized in a 1:1 ratio to 3 weeks of treatment with CONCERTA or generic Novo-Methylphenidate ER-C. Following 3 weeks of treatment, participants were crossed-over to receive the other treatment for an additional 3 weeks. Primary efficacy was assessed through the use of the Treatment Satisfaction Questionnaire for Medication, Version II (TSQM-II). Participants with ADHD treated with CONCERTA were more satisfied in terms of efficacy and side effects compared to those receiving an equivalent dose of generic Novo-Methylphenidate ER-C. All participants chose to continue with CONCERTA treatment at the conclusion of the study. Although CONCERTA and generic Novo-Methylphenidate ER-C have been deemed bioequivalent, however the present findings demonstrate clinically and statistically significant differences between generic and branded CONCERTA. Further investigation of these differences is warranted.

Measuring health-related quality of life in children living in HIV/AIDS-affected families in rural areas in Yunnan, China: Preliminary reliability and validity of the Chinese version of PedsQL 4.0 generic core scales.

PubMed

Xu, Tao; Wu, Zunyou; Yan, Zhihua; Rou, Keming; Duan, Song

2010-02-01

To investigate the preliminary reliability and validity of the Chinese Mandarin version of the Pediatric Quality of Life Inventory (PedsQL) 4.0 Generic Core Scales in a sample of general children and children living in HIV/AIDS-affected families. The PedsQL 4.0 was administered to 116 children aged 8-18 years from HIV/AIDS-affected families and 115 of their caregivers. The questionnaire was also administered to a control group of 109 children and 107 of their caregivers. Most of the self-report and proxy-report scales in both groups exceeded the reliability standard of 0.70, whereas the self-report emotional functioning and school functioning subscales were slightly less than 0.70. On average, children living in HIV/AIDS-affected families scored significantly lower than the control group. The level of agreement between self-reports and proxy reports was low. Correlations were higher on average for the younger age group than for the older age group. The Chinese Mandarin version of PedsQL 4.0 is a valid and reliable instrument for use with children living in HIV families. The health-related quality of life for children living in HIV families is lower than children from ordinary families.

Guide for Regional Integrated Assessments: Handbook of Methods and Procedures, Version 5.1. Appendix 1

NASA Technical Reports Server (NTRS)

Rosenzweig, Cynthia E.; Jones, James W.; Hatfield, Jerry; Antle, John; Ruane, Alex; Boote, Ken; Thorburn, Peter; Valdivia, Roberto; Porter, Cheryl; Janssen, Sander;

76 FR 13436 - Agency Information Collection Activities: Proposed Collection; Comment Request; Generic Clearance...

Federal Register 2010, 2011, 2012, 2013, 2014

2011-03-11

... target population to which generalizations will be made, the sampling frame, the sample design (including... for submission for other generic mechanisms that are designed to yield quantitative results. The MSPB... insights on perceptions and opinions, but are not statistical surveys that yield quantitative results that...

Using Rasch rating scale model to reassess the psychometric properties of the Persian version of the PedsQL™ 4.0 Generic Core Scales in school children.

PubMed

Jafari, Peyman; Bagheri, Zahra; Ayatollahi, Seyyed Mohamad Taghi; Soltani, Zahra

2012-03-13

Item response theory (IRT) is extensively used to develop adaptive instruments of health-related quality of life (HRQoL). However, each IRT model has its own function to estimate item and category parameters, and hence different results may be found using the same response categories with different IRT models. The present study used the Rasch rating scale model (RSM) to examine and reassess the psychometric properties of the Persian version of the PedsQL™ 4.0 Generic Core Scales. The PedsQL™ 4.0 Generic Core Scales was completed by 938 Iranian school children and their parents. Convergent, discriminant and construct validity of the instrument were assessed by classical test theory (CTT). The RSM was applied to investigate person and item reliability, item statistics and ordering of response categories. The CTT method showed that the scaling success rate for convergent and discriminant validity were 100% in all domains with the exception of physical health in the child self-report. Moreover, confirmatory factor analysis supported a four-factor model similar to its original version. The RSM showed that 22 out of 23 items had acceptable infit and outfit statistics (<1.4, >0.6), person reliabilities were low, item reliabilities were high, and item difficulty ranged from -1.01 to 0.71 and -0.68 to 0.43 for child self-report and parent proxy-report, respectively. Also the RSM showed that successive response categories for all items were not located in the expected order. This study revealed that, in all domains, the five response categories did not perform adequately. It is not known whether this problem is a function of the meaning of the response choices in the Persian language or an artifact of a mostly healthy population that did not use the full range of the response categories. The response categories should be evaluated in further validation studies, especially in large samples of chronically ill patients.

[Analysis of generic drug supply in France].

PubMed

Taboulet, F; Haramburu, F; Latry, Ph

2003-09-01

The list of generic medicines (LGM), published since 1997 by the Agence Française de Sécurité Sanitaire des Produits de Santé (AFFSSaPS), the French Medicine Agency, concerns a special part of the medicines reimbursed by the National Health Insurance (Social Security). The objectives of the present study were: i) to describe the components of this list, based on pharmaceutical, economical and therapeutic characteristics, ii) to study differences between generic and reference products (formulations, excipients, prices, etc.), iii) to analyze information on excipients provided to health care professionals. The 21st version of the LGM (April 2001) was used. Therapeutic value was retrieved from the 2001 AFSSaPS report on the therapeutic value of 4490 reimbursed medicines. Information on excipients in the LGM and the Vidal dictionary (reference prescription book in France) was compared. The products included in the LGM represent 20% of all reimbursed medicines. The mean price differences between generics and their reference products vary between 30 and 50% for more than two thirds of the generic groups. The therapeutic value of the products of the LGM was judged important in 71% of cases (vs 63% for the 4409 assessed medicines) and insufficient in 13% of cases (vs 19%). Information on excipients is often missing and sometimes erroneous. Although the LGM is regularly revised and thus the generic market in perpetual change, the 2001 cross description of this pharmaceutical market provides much informations and raises some concern.

A survey to determine the views of renal transplant patients on generic substitution in the UK.

PubMed

Al Ameri, Mubarak N; Whittaker, Clare; Tucker, Arthur; Yaqoob, Magdi; Johnston, Atholl

2011-08-01

Rising healthcare costs promote the generic substitution among patients because it is identifiable costs. A key concern is that patients should be involved in the decision of switching. The aim of this study was to examine renal transplant patients' views on generic substitution in the UK. A total of 163 renal patients were surveyed using 36 multiple-choice questions at Barts and The London Renal Transplant Clinic, in the UK. Transplant recipients over 18 years, able to read and write English and willing to fill in the questionnaire were targeted; 84% of patients were conscious of the availability of generic medicines, 70% understood the terms "generic" and "branded" in relation to medicines and 54% were aware of generic substitution practice. However, 75% did not know if they were taking generics and 84% felt that generics are not equivalent or only equivalent sometimes and they were uncertain that generics had the same quality as branded medicines. Moreover, many patients admitted that they would not accept the generic substitution of ciclosporin when become available in the UK. A number of factors such as patients' education, knowledge, severity of the disease, efficacy of generic medicines and patients' involvement in decisions regarding their health appear to drive patients' attitudes towards generic substitution. © 2011 The Authors. Transplant International © 2011 European Society for Organ Transplantation.

Sharing, samples, and generics: an antitrust framework.

PubMed

Carrier, Michael A

Rising drug prices are in the news. By increasing price, drug companies have placed vital, even life-saving, medicines out of the reach of consumers. In a recent development, brand firms have prevented generics even from entering the market. The ruse for this strategy involves risk-management programs known as Risk Evaluation and Mitigation Strategies ("REMS"). Pursuant to legislation enacted in 2007, the FDA requires REMS when a drug's risks (such as death or injury) outweigh its rewards. Brands have used this regime, intended to bring drugs to the market, to block generic competition. Regulations such as the federal Hatch-Waxman Act and state substitution laws foster widespread generic competition. But these regimes can only be effectuated through generic entry. And that entry can take place only if a generic can use a brand's sample to show that its product is equivalent. More than 100 generic firms have complained that they have not been able to access needed samples. One study of 40 drugs subject to restricted access programs found that generics' inability to enter cost more than $5 billion a year. Brand firms have contended that antitrust law does not compel them to deal with their competitors and have highlighted concerns related to safety and product liability in justifying their refusals. This Article rebuts these claims. It highlights the importance of samples in the regulatory regime and the FDA's inability to address the issue. It shows how a sharing requirement in this setting is consistent with Supreme Court caselaw. And it demonstrates that the brands' behavior fails the defendant-friendly "no economic sense" test because the conduct literally makes no sense other than by harming generics. Brands' denial of samples offers a textbook case of monopolization. In the universe of pharmaceutical antitrust behavior, other conduct--such as "pay for delay" settlements between brands and generics and "product hopping" from one drug to a slightly modified version--has received the lion's share of attention. But sample denials are overdue for antitrust scrutiny. This Article fills this gap. Given the failure of Congress and the FDA to remedy the issue, antitrust can play a crucial role in ensuring generic access to samples, affirming a linchpin of the pharmaceutical regime.

Estimated generic prices of cancer medicines deemed cost-ineffective in England: a cost estimation analysis

PubMed Central

Hill, Andrew; Redd, Christopher; Gotham, Dzintars; Erbacher, Isabelle; Meldrum, Jonathan; Harada, Ryo

2017-01-01

Objectives The aim of this study was to estimate lowest possible treatment costs for four novel cancer drugs, hypothesising that generic manufacturing could significantly reduce treatment costs. Setting This research was carried out in a non-clinical research setting using secondary data. Participants There were no human participants in the study. Four drugs were selected for the study: bortezomib, dasatinib, everolimus and gefitinib. These medications were selected according to their clinical importance, novel pharmaceutical actions and the availability of generic price data. Primary and secondary outcome measures Target costs for treatment were to be generated for each indication for each treatment. The primary outcome measure was the target cost according to a production cost calculation algorithm. The secondary outcome measure was the target cost as the lowest available generic price; this was necessary where export data were not available to generate an estimate from our cost calculation algorithm. Other outcomes included patent expiry dates and total eligible treatment populations. Results Target prices were £411 per cycle for bortezomib, £9 per month for dasatinib, £852 per month for everolimus and £10 per month for gefitinib. Compared with current list prices in England, these target prices would represent reductions of 74–99.6%. Patent expiry dates were bortezomib 2014–22, dasatinib 2020–26, everolimus 2019–25 and gefitinib 2017. The total global eligible treatment population in 1 year is 769 736. Conclusions Our findings demonstrate that affordable drug treatment costs are possible for novel cancer drugs, suggesting that new therapeutic options can be made available to patients and doctors worldwide. Assessing treatment cost estimations alongside cost-effectiveness evaluations is an important area of future research. PMID:28110283

Minimally Clinically Important Change in the Activity Measure for Post-Acute Care (AM-PAC), a Generic Patient-Reported Outcome Tool, in People With Low Back Pain.

PubMed

Lee, Natalie; Thompson, Nicolas R; Passek, Sandra; Stilphen, Mary; Katzan, Irene L

2017-11-01

The Activity Measure for Post-Acute Care (AM-PAC) is a generic metric of patient-reported functional status. The minimal clinically important difference (MCID) in the AM-PAC score has not been determined. The study objective was to determine the MCID for AM-PAC in people with low back pain. This was a retrospective cohort study. Anchor-based and distribution-based methods were used to estimate the MCID. The Modified Low Back Pain Disability Questionnaire was used as the anchor. Adults who had a primary ICD-9 code for low back pain in at least 1 outpatient physical therapist visit during an episode of care and who completed both the AM-PAC and the Modified Low Back Pain Disability Questionnaire in at least 2 visits during the care episode were included. The MCID was calculated for the AM-PAC basic mobility version as well its adapted version, which the Cleveland Clinic uses for patients 65 years old or older. A total of 1,271 participants were eligible for study. For the AM-PAC basic mobility version, anchor-based methods yielded MCID estimates of between 3.4 and 5.1, whereas distribution-based methods yielded estimates of 1.7 to 4.2. The minimal detectable change (MDC) for the AM-PAC basic mobility version was 3.3. For the adapted AM-PAC basic mobility version, the MCID was estimated to be between 2.9 and 4.0 via anchor-based methods and between 1.2 to 3.5 via distribution-based methods. The MDC for the adapted AM-PAC basic mobility version was 3.5. The estimated MCID was designed for people with low back pain only. The MCID ranged from 3.3 to 5.1 for the AM-PAC basic mobility version and 3.5 to 4 for the adapted version, with the MDC as the lower limit. Changes in the AM-PAC for people with low back pain may be interpreted using the estimated MCID. Future studies are needed to determine the AM-PAC MCID for populations other than those with low back pain. © 2017 American Physical Therapy Association

Determinants of Autobiographical Memory in Patients with Unilateral Temporal Lobe Epilepsy or Excisions

ERIC Educational Resources Information Center

St-Laurent, Marie; Moscovitch, Morris; Levine, Brian; McAndrews, Mary Pat

2009-01-01

Patients with unilateral temporal lobe epilepsy from hippocampal origin and patients with unilateral surgical excision of an epileptic focus located in the medial temporal lobe were compared to healthy controls on a version of the Autobiographical Interview (AI) adapted to assess memory for event-specific and generic personal episodes. For both…

An Introduction to X Window Application Development

DTIC Science & Technology

1992-03-23

Acquisition and Policy Evaluation program using Cognitive Feed- back ( ESKAPE /CF) from the SunView windowing system to X Window. The new application...the generic X Window System. This thesis converts an Expert System Knowledge Acquisition and Policy Evaluation program using Cognitive Feedback ( ESKAPE ...15 IV. XESKAPE/CF: THE X WINDOW VERSION OF ESKAPE /CF ........................ 16 A. FUNCTIONAL COMPARISON TO

Health-related quality of life in young adults in education, employment, or training: development of the Japanese version of Pediatric Quality of Life Inventory (PedsQL) Generic Core Scales Young Adult Version.

PubMed

Kaneko, Mei; Sato, Iori; Soejima, Takafumi; Kamibeppu, Kiyoko

2014-09-01

The purpose of the study is to develop a Japanese version of the Pediatric Quality of Life Inventory (PedsQL) Generic Core Scales Young Adult Version (PedsQL-YA-J) and determine the feasibility, reliability, and validity of the scales. Translation equivalence and content validity were verified using back-translation and cognitive debriefing tests. A total of 428 young adults recruited from one university, two vocational schools, or five companies completed questionnaires. We determined questionnaire feasibility, internal consistency, and test-retest reliability; checked concurrent validity against the Center for Epidemiologic Studies Depression Scale (CES-D); determined convergent and discriminant validity with the Medical Outcome Study 36-item Short Form Health Survey (SF-36); described known-groups validity with regard to subjective symptoms, illness or injury requiring regular medical visits, and depression; and verified factorial validity. All scales were internally consistent (Cronbach's coefficient alpha = 0.77-0.86); test-retest reliability was acceptable (intraclass correlation coefficient = 0.57-0.69); and all scales were concurrently valid with depression (Pearson's correlation coefficient = 0.43-0.57). The scales convergent and discriminant validity with the SF-36 and CES-D were acceptable. Evaluation of known-groups validity confirmed that the Physical Functioning scale was sensitive for subjective symptoms, the Emotional Functioning scale for depression, and the Work/School Functioning scale for illness or injury requiring regular medical visits. Exploratory factor analysis found a six-factor structure consistent with the assumed structure (cumulative proportion = 57.0%). The PedsQL-YA-J is suitable for assessing health-related quality of life in young adults in education, employment, or training, and for clinical trials and epidemiological research.

Psychometric properties of the Norwegian version of the Safety Attitudes Questionnaire (SAQ), Generic version (Short Form 2006).

PubMed

Deilkås, Ellen T; Hofoss, Dag

2008-09-22

How to protect patients from harm is a question of universal interest. Measuring and improving safety culture in care giving units is an important strategy for promoting a safe environment for patients. The Safety Attitudes Questionnaire (SAQ) is the only instrument that measures safety culture in a way which correlates with patient outcome. We have translated the SAQ to Norwegian and validated the translated version. The psychometric properties of the translated questionnaire are presented in this article. The questionnaire was translated with the back translation technique and tested in 47 clinical units in a Norwegian university hospital. SAQ's (the Generic version (Short Form 2006) the version with the two sets of questions on perceptions of management: on unit management and on hospital management) were distributed to 1911 frontline staff. 762 were distributed during unit meetings and 1149 through the postal system. Cronbach alphas, item-to-own correlations, and test-retest correlations were calculated, and response distribution analysis and confirmatory factor analysis were performed, as well as early validity tests. 1306 staff members completed and returned the questionnaire: a response rate of 68%. Questionnaire acceptability was good. The reliability measures were acceptable. The factor structure of the responses was tested by confirmatory factor analysis. 36 items were ascribed to seven underlying factors: Teamwork Climate, Safety Climate, Stress Recognition, Perceptions of Hospital Management, Perceptions of Unit Management, Working conditions, and Job satisfaction. Goodness-of-Fit Indices showed reasonable, but not indisputable, model fit. External validity indicators - recognizability of results, correlations with "trigger tool"-identified adverse events, with patient satisfaction with hospitalization, patient reports of possible maltreatment, and patient evaluation of organization of hospital work - provided preliminary validation. Based on the data from Akershus University Hospital, we conclude that the Norwegian translation of the SAQ showed satisfactory internal psychometric properties. With data from one hospital only, we cannot draw strong conclusions on its external validity. Further validation studies linking the SAQ-scores to patient outcome data should be performed.

Merger mania: mergers and acquisitions in the generic drug sector from 1995 to 2016.

PubMed

Gagnon, Marc-André; Volesky, Karena D

2017-08-22

Drug shortages and increasing generic drug prices are associated with low levels of competition. Mergers and acquisitions impact the level of competition. Record merger and acquisition activity was reported for the pharmaceutical sector in 2014/15, yet information on mergers and acquisitions in the generic drug sector are absent from the literature. This information is necessary to understand if and how such mergers and acquisitions can be a factor in drug shortages and increasing prices. Data on completed merger and acquisition deals that had a generic drug company being taken over (i.e. 'target') were extracted from Bloomberg Finance L.P. The number and announced value of deals are presented globally, for the United States, and globally excluding the United States annually from 1995 to 2016 in United States dollars. Generic drug companies comprised 9.3% of the value of all deals with pharmaceutical targets occurring from 1995 to 2016. Globally, in 1995 there were no deals, in 2014 there were 22 deals worth $1.86 billion, in 2015 there were 34 deals totalling $33.56 billion, and in 2016 there were 42 deals worth in excess of $44 billion. This substantial increase was partially attributed to Teva's 2016 acquisition of Allergan's generic drug business. The surge in mergers and acquisitions for 2015/16 was driven by deals in the United States, where they represented 89.7% of the dollar value of deals in those years. The recent blitz in mergers and acquisitions signals that the generic drug industry is undergoing a transformation, especially in the United States. This restructuring can negatively affect the level of competition that might impact prices and shortages for some products, emphasizing the importance of updating regulations and procurement policies.

A randomized controlled trial of a smoking cessation self-help intervention for dual users of tobacco cigarettes and E-cigarettes: Intervention development and research design.

PubMed

Meltzer, Lauren R; Simmons, Vani N; Sutton, Steven K; Drobes, David J; Quinn, Gwendolyn P; Meade, Cathy D; Unrod, Marina; Brandon, Karen O; Harrell, Paul T; Eissenberg, Thomas; Bullen, Christopher R; Brandon, Thomas H

2017-09-01

Electronic Nicotine Delivery Systems, also called electronic cigarettes or e-cigarettes, have been available for over a decade and use has been increasing dramatically. The primary reported reasons for use are to aid smoking cessation or reduction, yet a significant proportion appear to be long-term users of both products ("dual users"). Dual users may be motivated to quit smoking and might benefit from a behavioral intervention for smoking cessation. This paper describes the intervention development, as well as the design, methods, and data analysis plans for an ongoing randomized controlled trial (RCT). Formative research and learner verification were conducted to create a usable, understandable, and acceptable self-help intervention targeting dual users. The efficacy is being tested in an RCT with current dual users (N=2900) recruited nationally and randomized to one of three conditions. The Assessment Only (ASSESS) group only completes assessments. The Generic Self-Help (GENERIC) group receives non-targeted smoking cessation booklets and supplemental materials sent monthly over 18months. The e-cigarette Targeted Self-Help (eTARGET) group receives the newly developed intervention (targeted booklets and supplemental materials) sent over the same period. All participants complete self-report surveys every 3months over 2years. The primary study outcome is self-reported 7-day point prevalence abstinence. Cost-effectiveness metrics for the GENERIC and eTARGET interventions will also be calculated. Copyright © 2017 Elsevier Inc. All rights reserved.

Analysis of Medicine Prices in New Zealand and 16 European Countries.

PubMed

Vogler, Sabine; Kilpatrick, Kate; Babar, Zaheer-Ud-Din

2015-06-01

To compare prices of medicines, both originators and generics, in New Zealand and 16 European countries. Ex-factory price data as of December 2012 from New Zealand and 16 European countries were compared for a basket of 14 medicines, most of which were at least partially funded by the state in the 17 countries. Five medicines had, at least in some countries, generic versions on the market whose prices were also analyzed. Medicine price data for the 16 European countries were provided by the Pharma Price Information service. New Zealand medicine prices were retrieved from the New Zealand Pharmaceutical Schedule. Unit prices converted into euro were compared at the ex-factory price level. For the 14 medicines surveyed, considerable price differences at the ex-factory price level were identified. Within the European countries, prices in Greece, Portugal, the United Kingdom, and Spain ranked at the lower end, whereas prices in Switzerland, Germany, Denmark, and Sweden were at the upper end. The results for New Zealand compared with Europe were variable. New Zealand prices were found in the lowest quartile for five medicines and in the highest quartile for seven other products. Price differences between the originator products and generic versions ranged from 0% to 90% depending on the medicine and the country. Medicine prices varied considerably between European countries and New Zealand as well as among the European countries. These differences are likely to result from national pricing and reimbursement policies. Copyright © 2015 International Society for Pharmacoeconomics and Outcomes Research (ISPOR). Published by Elsevier Inc. All rights reserved.

Bioequivalence of generic and branded amoxicillin capsules in healthy human volunteers

PubMed Central

Pathak, Priyanka; Pandit, Vijaya A.; Dhande, Priti P.

2017-01-01

CONTEXT: The Medical Council of India urges doctors to prescribe generic drugs as far as possible. The Indian Medical Association had responded earlier saying that it requires guarantees on the quality of generic forms of drugs. Although no published scientific reports are available on the issue of therapeutic inequivalence, unconfirmed clinician accounts and newspaper reports of therapeutic inequivalence exist. AIM: This study was planned to ascertain whether bioequivalence of branded and generic amoxicillin capsule is comparable. SETTINGS AND DESIGN: An open-label, randomized, single-dose, two-treatment, two-sequence, two-period crossover oral bioequivalence study was conducted in 12 healthy, adult human subjects under fasting condition. MATERIALS AND METHODS: Serum samples, collected at 8 time points, were analyzed by a validated ultraviolet spectrophotometer method. Pharmacokinetic (PK) parameters such as area under the curve (AUC)0–t, AUC0–∞, Cmax, and Tmax were determined along with time above minimum inhibitory concentration (MIC). STATISTICAL ANALYSIS USED: The log-transformed PK parameters (Cmax, AUC0–t, AUC0–∞) were analyzed using a Two One-Sided Test ANOVA in SAS for each parameter. Tmax and MIC were analyzed by Wilcoxon rank-sum test in GraphPad Prism. RESULTS: Geometric mean ratio of Cmax fell within bioequivalence criteria. The upper and lower confidence limits of both AUC0–t and AUC0–∞ geometric mean ratio fell below bioequivalence criteria. Time above MIC of generic preparation was significantly lower than that of branded version. CONCLUSIONS: The generic capsule was not bioequivalent to the branded amoxicillin capsule. PMID:28706331

Dimensional scaling for impact cratering and perforation

NASA Technical Reports Server (NTRS)

Watts, Alan J.; Atkinson, Dale

1995-01-01

POD Associates have revisited the issue of generic scaling laws able to adequately predict (within better than 20 percent) cratering in semi-infinite targets and perforations through finite thickness targets. The approach used was to apply physical logic for hydrodynamics in a consistent manner able to account for chunky-body impacts such that the only variables needed are those directly related to known material properties for both the impactor and target. The analyses were compared and verified versus CTH hydrodynamic code calculations and existing data. Comparisons with previous scaling laws were also performed to identify which (if any) were good for generic purposes. This paper is a short synopsis of the full report available through the NASA Langley Research Center, LDEF Science Office.

Quality and efficiency of statin prescribing across countries with a special focus on South Africa: findings and future implications.

PubMed

Godman, Brian; Bishop, Iain; Campbell, Stephen M; Malmström, Rickard E; Truter, Ilse

2015-04-01

Statins are recommended first-line treatment for hyperlipidemia, with published studies suggesting limited differences between them. However, there are reports of under-dosing. South Africa has introduced measures to enhance generic utilization. Part one documents prescribed doses of statins in 2011. Part two determines the extent of generics versus originator and single-sourced statins in 2011 and their costs. Underdosing of simvastatin in 2011 with average prescribed dose of 23.7 mg; however, not for atorvastatin (20.91 mg) or rosuvastatin (15.02 mg). High utilization of generics versus originators at 93-99% for atorvastatin and simvastatin, with limited utilization of single-sourced statins (22% of total statins - defined daily dose basis), mirroring Netherlands, Sweden and UK. Generics priced 33-51% below originator prices. Opportunity to increase simvastatin dosing through education, prescribing targets and incentives. Opportunity to lower generic prices with generic simvastatin 96-98% below single-sourced prices in some European countries.

The limits of acceptable change process: modifications and clarifications

Treesearch

David N. Cole; Stephen F. McCool

1997-01-01

Limits of Acceptable Change (LAC) was originally formulated to deal with the issue of recreation carrying capacity in wilderness. Enthusiasm for the process has led to questions about its applicability to a broad range of natural resource issues—both within and outside of protected areas. This paper uses a generic version of the LAC process to identify situations where...

Coastal Surveillance Baseline Model Development

DTIC Science & Technology

2015-02-27

In the current STK model, a set of areas was defined for two reasons: To provide visual assistance during ship and aircraft route planning; and To...RF), electro-optic (EO), infrared (IR), and visual Partially Met The free version of STK can only generate simple generic sensors RQ-04 The model...25 APPENDIX A PLATFORM OBJECT ROUTE PLANNING PROCEDURE ............. A-1 APPENDIX B STK INSTALLATION

Effects of Explicit and Implicit Prompts on Students' Inquiry Practices in Computer-Supported Learning Environments in High School Earth Science

ERIC Educational Resources Information Center

Fang, Su-Chi; Hsu, Ying-Shao; Hsu, Wei Hsiu

2016-01-01

The study explored how to best use scaffolds for supporting students' inquiry practices in computer-supported learning environments. We designed a series of inquiry units assisted with three versions of written inquiry prompts (generic and context-specific); that is, three scaffold-fading conditions: implicit, explicit, and fading. We then…

Perceptions of the quality of generic medicines: implications for trust in public services within the local health system in Tumkur, India.

PubMed

Aivalli, Praveen Kumar; Elias, Maya Annie; Pati, Manoj Kumar; Bhanuprakash, Srinath; Munegowda, Chikkagollahalli; Shroff, Zubin Cyrus; Srinivas, Prashanth N

2017-01-01

Generic medicines are an important policy option to reduce out-of-pocket expenditure on medicines. However, negative perceptions of their quality affect utilisation and raise issues of confidence and trust in medicines and health services. The aim of the study was to test the quality of generic and branded medicines and explain negative perceptions towards generic medicines. The study was part of a larger study on access to medicines. Information on various quality parameters was collected for branded medicines and branded and unbranded generic versions of the same medicines from government and private pharmacies in Karnataka in Southern India. To assess perceptions related to quality and drivers of preferred point of care (public vs private), focus group discussions were conducted with diabetes and hypertension patients, health workers and private pharmacists. The results of the quality tests were assessed and thematic analysis was conducted on the qualitative data to develop a conceptual framework to explain perceptions of medicine and care quality in the local health system. The generic and branded variants of the medicines tested were of comparable quality. Contrary to the quality test results, patients' and health workers' perceptions of quality were largely in favour of branded medicines. Negative perceptions of medicine quality along with other drivers contribute towards choosing more expensive medicines in the private sector. Trust in the health system emerged as an underlying central theme that explained and drove choice of medicines and providers within the local health system. Negative perceptions of generic medicines and preferential promotion of branded medicines over generics by pharmaceutical companies could influence prescriber behaviour and affect trust in healthcare provided in public services. To succeed, access to medicines programmes need to systematically invest in information on quality of medicines and develop strategies to build trust in healthcare offered in government health services.

Perceptions of the quality of generic medicines: implications for trust in public services within the local health system in Tumkur, India

PubMed Central

Aivalli, Praveen Kumar; Elias, Maya Annie; Pati, Manoj Kumar; Bhanuprakash, Srinath; Munegowda, Chikkagollahalli; Shroff, Zubin Cyrus

2017-01-01

Introduction Generic medicines are an important policy option to reduce out-of-pocket expenditure on medicines. However, negative perceptions of their quality affect utilisation and raise issues of confidence and trust in medicines and health services. The aim of the study was to test the quality of generic and branded medicines and explain negative perceptions towards generic medicines. Methods The study was part of a larger study on access to medicines. Information on various quality parameters was collected for branded medicines and branded and unbranded generic versions of the same medicines from government and private pharmacies in Karnataka in Southern India. To assess perceptions related to quality and drivers of preferred point of care (public vs private), focus group discussions were conducted with diabetes and hypertension patients, health workers and private pharmacists. The results of the quality tests were assessed and thematic analysis was conducted on the qualitative data to develop a conceptual framework to explain perceptions of medicine and care quality in the local health system. Results The generic and branded variants of the medicines tested were of comparable quality. Contrary to the quality test results, patients’ and health workers’ perceptions of quality were largely in favour of branded medicines. Negative perceptions of medicine quality along with other drivers contribute towards choosing more expensive medicines in the private sector. Trust in the health system emerged as an underlying central theme that explained and drove choice of medicines and providers within the local health system. Conclusion Negative perceptions of generic medicines and preferential promotion of branded medicines over generics by pharmaceutical companies could influence prescriber behaviour and affect trust in healthcare provided in public services. To succeed, access to medicines programmes need to systematically invest in information on quality of medicines and develop strategies to build trust in healthcare offered in government health services. PMID:29531844

Health related quality of life measures in Arabic speaking populations: a systematic review on cross-cultural adaptation and measurement properties.

PubMed

Al Sayah, Fatima; Ishaque, Sana; Lau, Darren; Johnson, Jeffrey A

2013-02-01

This systematic review was conducted to identify generic health related quality of life (HRQL) measures translated into Arabic, and evaluate their cross-cultural adaptation and measurement properties. Six databases were searched, relevant journals were hand searched, and reference lists of included studies were reviewed. Previously established criteria were used to evaluate the cross-cultural adaptation of the identified instruments and their measurement properties. Twenty studies that reported the Arabic translations and adaptations of HRQL measures and/or their measurement properties were included in this review. The identified instruments were SF-36, RAND-36, WHOQOL-Bref, COOP/WONCA charts, EQ-5D, and QLI. Cross-cultural adaptations of all measures were of moderate to good quality, and evaluation of measurement properties was limited due to insufficiency of evidence. Based on cross-cultural adaptation evaluation, each instrument is more applicable to the population for whom it was adapted, and to other Arabic populations of similar culture and language specific idioms. This review facilitates the selection among existing Arabic versions of generic HRQL for use in particular Arabic countries. However, each of the translated versions requires further investigation of measurement properties before more concrete recommendations could be made.

Technical Note: Using k-means clustering to determine the number and position of isocenters in MLC-based multiple target intracranial radiosurgery.

PubMed

Yock, Adam D; Kim, Gwe-Ya

2017-09-01

To present the k-means clustering algorithm as a tool to address treatment planning considerations characteristic of stereotactic radiosurgery using a single isocenter for multiple targets. For 30 patients treated with stereotactic radiosurgery for multiple brain metastases, the geometric centroids and radii of each met were determined from the treatment planning system. In-house software used this as well as weighted and unweighted versions of the k-means clustering algorithm to group the targets to be treated with a single isocenter, and to position each isocenter. The algorithm results were evaluated using within-cluster sum of squares as well as a minimum target coverage metric that considered the effect of target size. Both versions of the algorithm were applied to an example patient to demonstrate the prospective determination of the appropriate number and location of isocenters. Both weighted and unweighted versions of the k-means algorithm were applied successfully to determine the number and position of isocenters. Comparing the two, both the within-cluster sum of squares metric and the minimum target coverage metric resulting from the unweighted version were less than those from the weighted version. The average magnitudes of the differences were small (-0.2 cm 2 and 0.1% for the within cluster sum of squares and minimum target coverage, respectively) but statistically significant (Wilcoxon signed-rank test, P < 0.01). The differences between the versions of the k-means clustering algorithm represented an advantage of the unweighted version for the within-cluster sum of squares metric, and an advantage of the weighted version for the minimum target coverage metric. While additional treatment planning considerations have a large influence on the final treatment plan quality, both versions of the k-means algorithm provide automatic, consistent, quantitative, and objective solutions to the tasks associated with SRS treatment planning using a single isocenter for multiple targets. © 2017 The Authors. Journal of Applied Clinical Medical Physics published by Wiley Periodicals, Inc. on behalf of American Association of Physicists in Medicine.

Effectiveness and safety of generic version of abacavir/lamivudine and efavirenz in treatment naïve HIV-infected patients: a nonrandomized, open-label, phase IV study in Cali-Colombia, 2011-2012.

PubMed

Galindo, Jaime; Amariles, Pedro; Mueses-Marín, Héctor F; Hincapié, Jaime A; González-Avendaño, Sebastián; Galindo-Orrego, Ximena

2016-10-03

Generic drug policies are often associated with concerns about the quality and effectiveness of these products. Phase IV clinical trials may be a suitable design to assess the effectiveness and safety of generic drugs. The objective of this study was to describe the effectiveness and the safety of the generic abacavir/lamivudine and efavirenz in treatment-naïve HIV-infected patients. A monocentric, nonrandomized, open-label, phase IV study in treatment naïve HIV-infected patients 18 years or older with indication to receive abacavir/lamivudine and efavirenz were recruited from a program that provides comprehensive outpatient consultation and continuing care. The primary end-point was to achieve viral load <40 copies/mL at 12 months after baseline to assess effectiveness. Secondary end-point of the study were 1) to asses increasing in T-CD4 lymphocytes levels as accompaniment to asses effectiveness, and 2) to assess both gastrointestinal, skin, and central nervous system symptoms, and lipid profile, cardiovascular risk, renal, and hepatic function as safety profile. Data were determined at baseline, 3, 6, and 12 months. Close clinical monitoring and pharmaceutical care were used for data collection. Wilcoxon matched-pairs signed-rank test was used to compare proportions or medians. Sixty patients were invited to participate in the study; 42 were enrolled and 33 completed the follow-up. Of the nine patients excluded from the study, only one was withdrawn due to adverse events. At 12 months, 31 of 42 patients (73.8 % in intention-to-treat analysis) achieved a viral load of HIV1 RNA <40 copies/mL. There was a significant increase (172 cells/mm 3 ) in the median for CD4 T lymphocyte count. The adverse events were mild and met the safety profile for this antiretroviral regimen, mainly of central nervous system symptoms, skin rash, lipid abnormalities, and an increase of 2 % in the median of the percentage of cardiovascular risk. The clinical outcomes of generic version of abacavir/lamivudine and efavirenz in HIV treatment naïve patients showed the expected safety and effectiveness profile of proprietary ARV drugs. Registro Público Cubano de Ensayos Clínicos (RPCEC) ID: RPCEC00000202 . Registered 19 November 2015.

Psychometric properties of the Chinese version of the pediatric quality of life inventory 4.0 Generic core scales among children with short stature.

PubMed

Wu, Hua-hong; Li, Hui; Gao, Qian

2013-05-30

The quality of life in children with short stature was rarely studied in China, so we explore these children's quality of life and psychometric properties of the Chinese version of the Pediatric Quality of Life Inventory 4.0(PedsQL4.0) Generic Core Scales among children with short stature. A total of 201 children aged 8 ~ 18 years from the short stature clinic and other clinics of capital institute of pediatrics attended this study. The questionnaires include demographic information and PedsQL4.0 generic core scales. According to children's height, we divided them into three groups: short stature, normal short and normal group, then compared the score of scales by the height category. Moreover, we analyzed the reliability and validity of PedsQL4.0 generic core scales in these 201 children. The child self-report total PedsQL mean score, for the short stature, normal short and normal groups were 77.77 ± 9.69, 83.50 ± 8.56 and 87.36 ± 7.23; the parent-proxy total PedsQL mean score were 77.62 ± 10.50, 82.69 ± 8.35 and 84.91 ± 9.96 respectively. Both for children self- and parent proxy-reports, the Cronbach's α coefficients of total scale, psychosocial health and social functioning ranged between 0.74 and 0.80, it ranged between 0.51 and 0.66 in other dimensions. For child self-reports, the correlation coefficients of 17 items' scores (total 23 items) with the scores of dimensions they belong to were above 0.5, with the highest 0.759; the other 6 items' correlation coefficients were below 0.5, with the lowest 0.280. For parent proxy-reports, the correlation coefficients of 19 items' scores with the scores of dimension they belong to were above 0.5, with the highest 0.793, the other 4 items' below 0.5 with the lowest 0.243. The quality of life in children with short stature is worse than their normal peers by Peds QL4.0 generic core scales, the statues of their quality of life was positively related to their stature.

Estimated generic prices of cancer medicines deemed cost-ineffective in England: a cost estimation analysis.

PubMed

Hill, Andrew; Redd, Christopher; Gotham, Dzintars; Erbacher, Isabelle; Meldrum, Jonathan; Harada, Ryo

2017-01-20

The aim of this study was to estimate lowest possible treatment costs for four novel cancer drugs, hypothesising that generic manufacturing could significantly reduce treatment costs. This research was carried out in a non-clinical research setting using secondary data. There were no human participants in the study. Four drugs were selected for the study: bortezomib, dasatinib, everolimus and gefitinib. These medications were selected according to their clinical importance, novel pharmaceutical actions and the availability of generic price data. Target costs for treatment were to be generated for each indication for each treatment. The primary outcome measure was the target cost according to a production cost calculation algorithm. The secondary outcome measure was the target cost as the lowest available generic price; this was necessary where export data were not available to generate an estimate from our cost calculation algorithm. Other outcomes included patent expiry dates and total eligible treatment populations. Target prices were £411 per cycle for bortezomib, £9 per month for dasatinib, £852 per month for everolimus and £10 per month for gefitinib. Compared with current list prices in England, these target prices would represent reductions of 74-99.6%. Patent expiry dates were bortezomib 2014-22, dasatinib 2020-26, everolimus 2019-25 and gefitinib 2017. The total global eligible treatment population in 1 year is 769 736. Our findings demonstrate that affordable drug treatment costs are possible for novel cancer drugs, suggesting that new therapeutic options can be made available to patients and doctors worldwide. Assessing treatment cost estimations alongside cost-effectiveness evaluations is an important area of future research. 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/.

Development of a New Branded UK Food Composition Database for an Online Dietary Assessment Tool

PubMed Central

Carter, Michelle C.; Hancock, Neil; Albar, Salwa A.; Brown, Helen; Greenwood, Darren C.; Hardie, Laura J.; Frost, Gary S.; Wark, Petra A.; Cade, Janet E.

2016-01-01

The current UK food composition tables are limited, containing ~3300 mostly generic food and drink items. To reflect the wide range of food products available to British consumers and to potentially improve accuracy of dietary assessment, a large UK specific electronic food composition database (FCDB) has been developed. A mapping exercise has been conducted that matched micronutrient data from generic food codes to “Back of Pack” data from branded food products using a semi-automated process. After cleaning and processing, version 1.0 of the new FCDB contains 40,274 generic and branded items with associated 120 macronutrient and micronutrient data and 5669 items with portion images. Over 50% of food and drink items were individually mapped to within 10% agreement with the generic food item for energy. Several quality checking procedures were applied after mapping including; identifying foods above and below the expected range for a particular nutrient within that food group and cross-checking the mapping of items such as concentrated and raw/dried products. The new electronic FCDB has substantially increased the size of the current, publically available, UK food tables. The FCDB has been incorporated into myfood24, a new fully automated online dietary assessment tool and, a smartphone application for weight loss. PMID:27527214

Development of a New Branded UK Food Composition Database for an Online Dietary Assessment Tool.

PubMed

Carter, Michelle C; Hancock, Neil; Albar, Salwa A; Brown, Helen; Greenwood, Darren C; Hardie, Laura J; Frost, Gary S; Wark, Petra A; Cade, Janet E

2016-08-05

The current UK food composition tables are limited, containing ~3300 mostly generic food and drink items. To reflect the wide range of food products available to British consumers and to potentially improve accuracy of dietary assessment, a large UK specific electronic food composition database (FCDB) has been developed. A mapping exercise has been conducted that matched micronutrient data from generic food codes to "Back of Pack" data from branded food products using a semi-automated process. After cleaning and processing, version 1.0 of the new FCDB contains 40,274 generic and branded items with associated 120 macronutrient and micronutrient data and 5669 items with portion images. Over 50% of food and drink items were individually mapped to within 10% agreement with the generic food item for energy. Several quality checking procedures were applied after mapping including; identifying foods above and below the expected range for a particular nutrient within that food group and cross-checking the mapping of items such as concentrated and raw/dried products. The new electronic FCDB has substantially increased the size of the current, publically available, UK food tables. The FCDB has been incorporated into myfood24, a new fully automated online dietary assessment tool and, a smartphone application for weight loss.

Scientific and Regulatory Considerations for Generic Complex Drug Products Containing Nanomaterials.

PubMed

Zheng, Nan; Sun, Dajun D; Zou, Peng; Jiang, Wenlei

2017-05-01

In the past few decades, the development of medicine at the nanoscale has been applied to oral and parenteral dosage forms in a wide range of therapeutic areas to enhance drug delivery and reduce toxicity. An obvious response to these benefits is reflected in higher market shares of complex drug products containing nanomaterials than that of conventional formulations containing the same active ingredient. The surging market interest has encouraged the pharmaceutical industry to develop cost-effective generic versions of complex drug products based on nanotechnology when the associated patent and exclusivity on the reference products have expired. Due to their complex nature, nanotechnology-based drugs present unique challenges in determining equivalence standards between generic and innovator products. This manuscript attempts to provide the scientific rationales and regulatory considerations of key equivalence standards (e.g., in vivo studies and in vitro physicochemical characterization) for oral drugs containing nanomaterials, iron-carbohydrate complexes, liposomes, protein-bound drugs, nanotube-forming drugs, and nano emulsions. It also presents active research studies in bridging regulatory and scientific gaps for establishing equivalence of complex products containing nanomaterials. We hope that open communication among industry, academia, and regulatory agencies will accelerate the development and approval processes of generic complex products based on nanotechnology.

Oxaliplatin-related neuropathy in Indian patients - no difference between generic and original molecules.

PubMed

Sirohi, Bhawna; Ostwal, Vikas; Dawood, Shaheenah; Lopes, Gilberto; Talole, Sanjay; Nashikkar, Chaitali; Shrikhande, Shailesh

2016-01-01

Oxaliplatin-induced neuropathy is a dose-limiting toxicity that significantly affects patients' quality of life. The aim of this study was to compare its occurrence between a generic versus the original molecule in Indian patients. Between August 2012 and July 2013, 163 patients receiving oxaliplatin were prospectively enrolled. A data recording form was used in the clinic to record detailed information. The median age of patients was 55 years (range, 19-79). Chemotherapy regimens used included: capecitabine, oxaliplatin (59), epirubicin, oxaliplatin, and capecitabine (20), docetaxel, oxaliplatin, and capecitabine (11), 5-FU, leucovorin, oxaliplatin (9), and gemcitabine-oxaliplatin (64). The median cumulative dose of oxaliplatin was 780 mg/m 2 . Eighty patients received the original version and 83 the generic one. Overall, 63 patients (38%) developed neuropathy. There was no significant difference in the incidence of neuropathy between the two forms of oxaliplatin used ( P = 0.50). Forty-nine percent of female patients had neuropathy as compared to 30% of male patients ( P = 0.014). Older patients had a trend toward a higher incidence of neuropathy: 44% of patients above age fifty developed neuropathy compared to 30% of patients younger than 50 ( P = 0.06). This is the first study to specifically show that neuropathy rates do not vary with the use of generic versus original oxaliplatin.

[Memantine: from the original brand to generics].

PubMed

Titova, N V

Memantine is the first clinically available glutamate antagonist, with an antagonist action at the N-methyl-D-aspartate receptors in the brain, for correction of cognitive and behavioral functions in neurodegenerative disorders. Glutamate mediated excitotoxic neuronal damage has been implicated in Alzheimer's disease (AD) and other parkinsonism-related dementias and, therefore, memantine represents a novel mode of action to counteract the glutamate-mediated excitotoxicity. In moderate to severe AD, 20 mg of memantine shows a positive effect on cognition, mood, behavior and the ability to perform activities of daily living. Long-term studies show good tolerability of memantine with an acceptable side-effect profile. In recent years, there have been a proliferation of a number of companies producing generic memantine with different trade names. In Russia, the first memantine generic drug noojerone was approved in 2010 and its use has since been supported by a growing evidence base of efficacy in real-life clinical practice. Postmarketing studies show that noojerone provides long-term and effective therapy in patients with moderate and severe Alzheimer's dementia. This observation is supported by the clinically significant therapeutic effect of noojerone on cognitive and daily functioning, behavioral and psychotic symptoms of dementia and a reduction of the burden on caregivers. This generic version of memantine is affordable and, therefore, reduces financial burden on patients and improves compliance with treatment.

Linking Semantic and Knowledge Representations in a Multi-Domain Dialogue System

DTIC Science & Technology

2007-06-01

accuracy evaluation presented in the next section shows that the generic version of the grammar performs similarly well on two evaluation domains...of extra insertions; for example, discourse adverbials such as now were inserted if present in the lattice. In addition, different tense and pronoun...automatic lexicon specialization technique improves parser speed and accuracy. 1 Introduction This paper presents an architecture of a language

Using Rasch rating scale model to reassess the psychometric properties of the Persian version of the PedsQLTM 4.0 Generic Core Scales in school children

PubMed Central

2012-01-01

Background Item response theory (IRT) is extensively used to develop adaptive instruments of health-related quality of life (HRQoL). However, each IRT model has its own function to estimate item and category parameters, and hence different results may be found using the same response categories with different IRT models. The present study used the Rasch rating scale model (RSM) to examine and reassess the psychometric properties of the Persian version of the PedsQLTM 4.0 Generic Core Scales. Methods The PedsQLTM 4.0 Generic Core Scales was completed by 938 Iranian school children and their parents. Convergent, discriminant and construct validity of the instrument were assessed by classical test theory (CTT). The RSM was applied to investigate person and item reliability, item statistics and ordering of response categories. Results The CTT method showed that the scaling success rate for convergent and discriminant validity were 100% in all domains with the exception of physical health in the child self-report. Moreover, confirmatory factor analysis supported a four-factor model similar to its original version. The RSM showed that 22 out of 23 items had acceptable infit and outfit statistics (<1.4, >0.6), person reliabilities were low, item reliabilities were high, and item difficulty ranged from -1.01 to 0.71 and -0.68 to 0.43 for child self-report and parent proxy-report, respectively. Also the RSM showed that successive response categories for all items were not located in the expected order. Conclusions This study revealed that, in all domains, the five response categories did not perform adequately. It is not known whether this problem is a function of the meaning of the response choices in the Persian language or an artifact of a mostly healthy population that did not use the full range of the response categories. The response categories should be evaluated in further validation studies, especially in large samples of chronically ill patients. PMID:22414135

Economic savings versus health losses: The cost-effectiveness of generic antiretroviral therapy in the United States

PubMed Central

Walensky, Rochelle P.; Sax, Paul E.; Nakamura, Yoriko M.; Weinstein, Milton C.; Pei, Pamela P.; Freedberg, Kenneth A.; Paltiel, A. David; Schackman, Bruce R.

2013-01-01

Background US HIV treatment guidelines recommend branded once-daily, one-pill efavirenz/emtricitabine/tenofovir as preferred first-line antiretroviral treatment (ART). With the anticipated approval of generic efavirenz in 2012 in the US, the cost of a once-daily, three-pill alternative (generic efavirenz, generic lamivudine, tenofovir) will decrease, but adherence and virologic suppression may be reduced. Objectives To assess the clinical impact, costs, and cost-effectiveness of the generic-based three-pill regimen compared to the branded, co-formulated regimen. To project the potential national savings in the first year of a switch to generic-based ART. Design Mathematical simulation of HIV disease. Data Sources Published data from US clinical trials and observational cohorts. Target Population HIV-infected patients eligible to start on or switch to an efavirenz-based generic ART regimen. Time Horizon Lifetime, One-year Perspective US health system Interventions No ART (for comparison), Three-pill Generic ART, and Branded ART Outcome Measures Quality-adjusted life expectancy, costs, and incremental cost-effectiveness ratios (ICER, $/quality-adjusted life expectancy [QALY]). Results of Base-Case Analysis Compared to No ART, Generic ART has an ICER of $21,100/QALY. Compared to Generic ART, Branded ART increases lifetime costs by $42,500, and per-person survival gains by 0.37 QALYs, for an ICER of $114,800/QALY. Estimated first-year savings, if all eligible US patients start on or switch to Generic ART, are $920 million. Results of Sensitivity Analysis Most plausible assumptions about Generic ART efficacy and costs lead to Branded ART ICERs >$100,000/QALY. Limitations The efficacy and price reduction associated with generics are unknown; estimates are intended to be conservative. Conclusions Compared to a slightly less effective generic-based regimen, the cost-effectiveness of first-line Branded ART exceeds $100,000/QALY. Generic-based ART in the US could yield substantial budgetary savings to HIV programs. PMID:23318310

A Generic and Efficient E-field Parallel Imaging Correlator for Next-Generation Radio Telescopes

NASA Astrophysics Data System (ADS)

Thyagarajan, Nithyanandan; Beardsley, Adam P.; Bowman, Judd D.; Morales, Miguel F.

2017-05-01

Modern radio telescopes are favouring densely packed array layouts with large numbers of antennas (NA ≳ 1000). Since the complexity of traditional correlators scales as O(N_A^2), there will be a steep cost for realizing the full imaging potential of these powerful instruments. Through our generic and efficient E-field Parallel Imaging Correlator (epic), we present the first software demonstration of a generalized direct imaging algorithm, namely the Modular Optimal Frequency Fourier imager. Not only does it bring down the cost for dense layouts to O(N_A log _2N_A) but can also image from irregular layouts and heterogeneous arrays of antennas. epic is highly modular, parallelizable, implemented in object-oriented python, and publicly available. We have verified the images produced to be equivalent to those from traditional techniques to within a precision set by gridding coarseness. We have also validated our implementation on data observed with the Long Wavelength Array (LWA1). We provide a detailed framework for imaging with heterogeneous arrays and show that epic robustly estimates the input sky model for such arrays. Antenna layouts with dense filling factors consisting of a large number of antennas such as LWA, the Square Kilometre Array, Hydrogen Epoch of Reionization Array, and Canadian Hydrogen Intensity Mapping Experiment will gain significant computational advantage by deploying an optimized version of epic. The algorithm is a strong candidate for instruments targeting transient searches of fast radio bursts as well as planetary and exoplanetary phenomena due to the availability of high-speed calibrated time-domain images and low output bandwidth relative to visibility-based systems.

The EULAR Outcome Measures Library: development and an example from a systematic review for systemic lupus erythematous instruments.

PubMed

Castrejon, I; Carmona, L; Agrinier, N; Andres, M; Briot, K; Caron, M; Christensen, R; Consolaro, A; Curbelo, R; Ferrer, Montserrat; Foltz, Violaine; Gonzalez, C; Guillemin, F; Machado, P M; Prodinger, Birgit; Ravelli, A; Scholte-Voshaar, M; Uhlig, T; van Tuyl, L H D; Zink, A; Gossec, L

2015-01-01

Patient reported outcomes (PROs) are relevant in rheumatology. Variable accessibility and validity of commonly used PROs are obstacles to homogeneity in evidence synthesis. The objective of this project was to provide a comprehensive library of "validated PROs". A launch meeting with rheumatologists, PROs methodological experts, and patients, was held to define the library's aims and scope, and basic requirements. To feed the library we performed systematic reviews on selected diseases and domains. Relevant information on PROs was collected using standardised data collection forms based on the COSMIN checklist. The EULAR Outcomes Measures Library (OML), whose aims are to provide and to advise on PROs on a user-friendly manner albeit based on scientific grounds, has been launched and made accessible to all. PROs currently included cover any domain and, are generic or specifically target to the following diseases: rheumatoid arthritis, osteoarthritis, spondyloarthritis, low back pain, systemic lupus erythematosus, gout, osteoporosis, juvenile idiopathic arthritis, and fibromyalgia. Up to 236 instruments (106 generic and 130 specific) have been identified, evaluated, and included. The systematic review for SLE, which yielded 10 specific instruments, is presented here as an example. The OML website includes, for each PRO, information on the construct being measured and the extent of validation, recommendations for use, and available versions; it also contains a glossary on common validation terms. The OML is an in progress library led by rheumatologists, related professionals and patients, that will help to better understand and apply PROs in rheumatic and musculoskeletal diseases.

Generic Reference in English, Arabic and Malay: A Cross Linguistic Typology and Comparison

ERIC Educational Resources Information Center

AL-Malki, Eidhah Abdullah; Majid, Norazman Abdul; Omar, Noor Abidah Mohd

2014-01-01

According to the Longman Grammar of Spoken and Written English 1999 by Biber et al. (p. 266) generic article uses are more than twice as common in academic English than in conversation or fiction. This is an area that English for Academic Purpose (EPA) textbooks and teachers would need to target more than general English teaching. This paper is…

TARGETED THERAPY: Generic imatinib — impact on frontline and salvage therapy for CML

PubMed Central

Gorkin, Larry; Kantarjian, Hagop

2017-01-01

Imatinib has revolutionized the treatment of chronic myeloid leukaemia (CML). In 2016, generic imatinib will be introduced into the US market. We analyse the potential impact of this new product on patient care and optimal CML therapy, and comment on the effect that distorted cancer drug pricing in the USA will have on treatment for patients with limited therapeutic options. PMID:27098218

Simulation system architecture design for generic communications link

NASA Technical Reports Server (NTRS)

Tsang, Chit-Sang; Ratliff, Jim

1986-01-01

This paper addresses a computer simulation system architecture design for generic digital communications systems. It addresses the issues of an overall system architecture in order to achieve a user-friendly, efficient, and yet easily implementable simulation system. The system block diagram and its individual functional components are described in detail. Software implementation is discussed with the VAX/VMS operating system used as a target environment.

Drug Product Life-Cycle Management as Anticompetitive Behavior: The Case of Memantine.

PubMed

Capati, Vincent C; Kesselheim, Aaron S

2016-04-01

A "product hop" involves the substitution of a new formulation of a prescription drug by a pharmaceutical manufacturer for an old version to forestall generic competition. In 2015, for example, Forest Laboratories, the brand-name drug manufacturer of memantine, an Alzheimer's disease treatment, introduced an extended-release version and tried to restrict patient access to the previous version. Product hops can lead to useful incremental innovation but can also have major public health implications by disrupting patients on stable treatment regimens and increasing costs for patients and payers. This commentary reviews alleged anticompetitive product hopping in the case of memantine, which involved proposed conduct that would have left Alzheimer's disease patients with no effective choice but to transition to memantine XR. Policy solutions that can limit anticompetitive product hops include raising the bar for obtaining patents on new drug product formulations and changing automatic generic substitution laws. No outside funding supported this research. To support his work at PORTAL in the summer of 2015, Capati was the recipient of the University of New Hampshire School of Law Rudman Center Public Service Fellowship. Kesselheim's research was supported by Greenwall Faculty Scholars program, the Laura and John Arnold Foundation, and the Harvard Program in Therapeutic Science. In 2013, Kesselheim served as an expert on behalf of a class of individual plaintiffs against Warner Chilcott regarding potential antitrust violations Kesselheim was responsible for concept and design of this commentary. Capati took the lead in data collection and analysis, along with Kesselheim. Capati wrote the manuscript, which was revised by primarily by Kesselheim, along with Capati.

A short generic measure of work stress in the era of globalization: effort-reward imbalance.

PubMed

Siegrist, Johannes; Wege, Natalia; Pühlhofer, Frank; Wahrendorf, Morten

2009-08-01

We evaluate psychometric properties of a short version of the original effort-reward imbalance (ERI) questionnaire. This measure is of interest in the context of assessing stressful work conditions in the era of economic globalization. In a representative sample of 10,698 employed men and women participating in the longitudinal Socio-Economic Panel (SOEP) in Germany, a short version of the ERI questionnaire was included in the 2006 panel wave. Structural equation modeling and logistic regression analysis were applied. In addition to satisfactory internal consistency of scales, a model representing the theoretical structure of the scales provided the best data fit in a competitive test (RMSEA = 0.059, CAIC = 4124.19). Scoring high on the ERI scales was associated with elevated risks of poor self-rated health. This short version of the ERI questionnaire reveals satisfactory psychometric properties, and can be recommended for further use in research and practice.

Category-Based Errors and the Accessibility of Unbiased Spatial Memories: A Retrieval Model

ERIC Educational Resources Information Center

Sampaio, Cristina; Wang, Ranxiao Frances

2009-01-01

Studies have consistently shown a spatial memory bias such that a target location is remembered toward the prototypical location of the region to which the target belongs, indicating a blending between the target's specific information and the generic information of its region. The authors investigated whether people retain a veridical…

Pharma industry in India.

PubMed

Sundaram, V M

2008-01-01

Globally ranked fourth by volume and 13th in value, the Indian pharma industry is a leading producer of high-quality, low-cost generic drugs. Its 14% share of the USD 57 billion world generic market is expected to increase to 50% by 2010. With the advantages of cost competitiveness, ability and experience in reverse engineering, availability of skilled scientific and engineering personnel and the capability to produce raw materials for a wide range of drugs from the basic stage, the industry delivers the entire range of therapeutic products. McKinsey & Co. predict that India's pharmaceutical market could reach a size of USD 20 billion by 2015, becoming one of the top 10 drug markets in the world. Generic versions of the cardiovascular drug carvedilol, ANDA-approved allopurinol, verapamil SR and the anticancer drug paclitaxel are some of the recent products introduced by Indian companies, with Caraco, Ranbaxy, Dabur, Dr. Reddy's, Nicholas Piramal India, leading the list. Setting up of integrated drug development companies and aggressive entries into the Japanese drug market have provided further impetus to the country's pharma manufacturing arena.

Cross-cultural adaptation and psychometric properties of the Brazilian-Portuguese version of the VSP-A (Vécu et Santé Perçue de l'Adolescent), a health-related quality of life (HRQoL) instrument for adolescents, in a healthy Brazilian population

PubMed Central

2011-01-01

Background Health-related quality of life (HRQoL) assessment, encompassing the adolescents' perceptions of their mental, physical, and social health and well-being is increasingly considered an important outcome to be used to identify population health needs and to provide targeted medical care. Although validated instruments are essential for accurately assessing HRQoL outcomes, there are few cross-culturally adapted tools for use in Brazil, and none designed exclusively for use among adolescents. The Vécu et Santé Perçue de l'Adolescent (VSP-A) is a generic, multidimensional self-reported instrument originally developed and validated in France that evaluates HRQoL of ill and healthy adolescents. Purpose To cross-culturally adapt and validate the Brazilian-Portuguese version of the VSP-A, a generic HRQoL measure for adolescents originally developed in France. Methods The VSP-A was translated following a well-validated forward-backward process leading to the Brazilian version. The psychometric evaluation was conducted in a sample of 446 adolescents (14-18 years) attending 2 public high schools of São Gonçalo City. The adolescents self-reported the Brazilian VSP-A, the validated Psychosomatic Symptom Checklist and socio-demographic information. A retest evaluation was carried out on a sub-sample (n = 195) at a two-week interval. The internal construct validity was assessed through confirmatory factor analysis (CFA), multi-trait scaling analyses, Rasch analysis evaluating unidimensionality of each scale and Cronbach's alpha coefficients. The reproducibility was evaluated by intra-class correlation coefficients (ICC). Zumbo's ordinal logistic regression analysis was used to detect differential item functioning (DIF) between the Brazilian and the French items. External construct validity was investigated testing expected differences between groups using one-way analysis of variance (ANOVA), Mann-Whitney tests and the univariate general regression linear model. Results CFA showed an acceptable fit (RMSEA=0.05; CFI=0.93); 94% of scaling success was found for item-internal consistency and 98% for item discriminant validity. The items showed good fit to the Rasch model except 3 items with an INFIT at the upper threshold. Cronbach's Alpha ranged from 0.60 to 0.85. Test-retest reliability was moderate to good (ICC=0.55-0.82). DIF was evidenced in 4 out of 36 items. Expected patterns of differences were confirmed with significantly lower physical, psychological well being and vitality reported by symptomatic adolescents. Conclusions Although DIF in few items and responsiveness must be further explored, the Brazilian version of VSP-A demonstrated an acceptable validity and reliability in adolescents attending school and might serve as a starting point for more specific clinical investigations. PMID:21272317

Health-Related Quality of Life and Cognitive Functioning from the Perspective of Parents of School-Aged Children with Asperger's Syndrome Utilizing the PedsQL[TM

ERIC Educational Resources Information Center

Limbers, Christine A.; Heffer, Robert W.; Varni, James W.

2009-01-01

HRQOL as a multidimensional construct has not been previously investigated in children with Asperger's Syndrome. The objective of the present study was to examine the initial feasibility, reliability, and validity of the PedsQL[TM] 4.0 Generic Core Scales and PedsQL[TM] Cognitive Functioning Scale parent proxy-report versions in school-aged…

PedsQLTM 4.0 Generic Core Scales for adolescents in the Yoruba language: translation and general psychometric properties.

PubMed

Atilola, Olayinka; Stevanović, Dejan

2014-04-01

Quality of life (QOL) is a universally accepted concept for measuring the impact of different aspects of life on general well-being. Adaptation of existing QOL instruments to local cultures has been identified as a better strategy than development of new ones. To translate and adapt the Paediatric Quality of Life Inventory™ Version 4.0 Generic Core Scales (PedsQL™) to the Yoruba language and culture and to test the psychometric properties of the adapted instrument among adolescents. Psychometric properties including internal consistency reliability, construct and factorial validity of the Yoruba version of PedsQL™ were evaluated using standard procedures. The self report and proxy scales of the Yoruba PedsQL™ were developed with good cultural relevance and semantic/conceptual equivalence. Results from 527 adolescents revealed a Cronbach's coefficient which exceeded 0.7 for internal consistency reliability for all scores. The healthy subjects reported higher PedsQL™ scores than those with mental health and physical problems, which confirmed construct validity. Confirmatory factor analysis revealed a good model fit for the Psychosocial Health score, but not for the other measures. The Yoruba PedsQL™ is culturally appropriate and with good internal consistency, reliability and construct validity. More work is needed regarding its factorial validity.

Generic oncology drugs: are they all safe?

PubMed

Yang, Y Tony; Nagai, Sumimasa; Chen, Brian K; Qureshi, Zaina P; Lebby, Akida A; Kessler, Samuel; Georgantopoulos, Peter; Raisch, Dennis W; Sartor, Oliver; Hermanson, Terhi; Kane, Robert C; Hrushesky, William J; Riente, Joshua J; Norris, LeAnn B; Bobolts, Laura R; Armitage, James O; Bennett, Charles L

2016-11-01

Although the availability of generic oncology drugs allows access to contemporary care and reduces costs, there is international variability in the safety of this class of drugs. In this Series paper, we review clinical, policy, safety, and regulatory considerations for generic oncology drugs focusing on the USA, Canada, the European Union (EU), Japan, China, and India. Safety information about generic formulations is reviewed from one agent in each class, for heavy metal drugs (cisplatin), targeted agents (imatinib), and cytotoxic agents (docetaxel). We also review regulatory reports from Japan and the USA, countries with the largest pharmaceutical expenditures. Empirical studies did not identify safety concerns in the USA, Canada, the EU, and Japan, where regulations and enforcement are strong. Although manufacturing problems for generic pharmaceuticals exist in India, where 40% of all generic pharmaceuticals used in the USA are manufactured, increased inspections and communication by the US Food and Drug Administration are occurring, facilitating oversight and enforcement. No safety outbreaks among generic oncology drugs were reported in developed countries. For developing countries, oversight is less intensive, and concerns around drug safety still exist. Regulatory agencies should collaboratively develop procedures to monitor the production, shipment, storage, and post-marketing safety of generic oncology drugs. Regulatory agencies for each country should also aim towards identical definitions of bioequivalence, the cornerstone of regulatory approval. Copyright © 2016 Elsevier Ltd. All rights reserved.

Longitudinal factorial invariance of the PedsQL 4.0 Generic Core Scales child self-report Version: one year prospective evidence from the California State Children's Health Insurance Program (SCHIP).

PubMed

Varni, James W; Limbers, Christine A; Newman, Daniel A; Seid, Michael

2008-11-01

The measurement of health-related quality of life (HRQOL) in pediatric medicine and health services research has grown significantly over the past decade. The paradigm shift toward patient-reported outcomes (PROs) has provided the opportunity to emphasize the value and critical need for pediatric patient self-report. In order for changes in HRQOL/PRO outcomes to be meaningful over time, it is essential to demonstrate longitudinal factorial invariance. This study examined the longitudinal factor structure of the PedsQL 4.0 Generic Core Scales over a one-year period for child self-report ages 5-17 in 2,887 children from a statewide evaluation of the California State Children's Health Insurance Program (SCHIP) utilizing a structural equation modeling framework. Specifying four- and five-factor measurement models, longitudinal structural equation modeling was used to compare factor structures over a one-year interval on the PedsQL 4.0 Generic Core Scales. While the four-factor conceptually-derived measurement model for the PedsQL 4.0 Generic Core Scales produced an acceptable fit, the five-factor empirically-derived measurement model from the initial field test of the PedsQL 4.0 Generic Core Scales produced a marginally superior fit in comparison to the four-factor model. For the five-factor measurement model, the best fitting model, strict factorial invariance of the PedsQL 4.0 Generic Core Scales across the two measurement occasions was supported by the stability of the comparative fit index between the unconstrained and constrained models, and several additional indices of practical fit including the root mean squared error of approximation, the non-normed fit index, and the parsimony normed fit index. The findings support an equivalent factor structure on the PedsQL 4.0 Generic Core Scales over time. Based on these data, it can be concluded that over a one-year period children in our study interpreted items on the PedsQL 4.0 Generic Core Scales in a similar manner.

Comparison of Informed Consent Preferences for Multiplex Genetic Carrier Screening among a Diverse Population.

PubMed

Reeves, Ashley; Trepanier, Angela

2016-02-01

Multiplex genetic carrier screening is increasingly being integrated into reproductive care. Obtaining informed consent becomes more challenging as the number of screened conditions increases. Implementing a model of generic informed consent may facilitate informed decision-making. Current Wayne State University students and staff were invited to complete a web-based survey by blast email solicitation. Participants were asked to determine which of two generic informed consent scenarios they preferred: a brief versus a detailed consent. They were asked to rank the importance of different informational components in making an informed decision and to provide demographic information. Comparisons between informational preferences, demographic variables and scenario preferences were made. Six hundred ninety three participants completed the survey. When evaluating these generic consents, the majority preferred the more detailed consent (74.5%), and agreed that it provided enough information to make an informed decision (89.5%). Those who thought it would be more important to know the severity of the conditions being screened (p = .002) and range of symptoms (p = .000) were more likely to prefer the more detailed consent. There were no significant associations between scenario preferences and demographic variables. A generic consent was perceived to provide sufficient information for informed decision making regarding multiplex carrier screening with most preferring a more detailed version of the consent. Individual attitudes rather than demographic variables influenced preferences regarding the amount of information that should be included in the generic consent. The findings have implications for how clinicians approach providing tailored informed consent.

Drug substitution associated with a hospital stay in Belgium: a retrospective analysis of a claims database.

PubMed

Simoens, Steven; Dubois, Cécile; Spinewine, Anne; Foulon, Veerle; Paulus, Dominique

2014-04-01

This study measures the extent of drug substitution associated with a hospital stay in Belgium. Data were extracted from the 2006-2007 dataset of the Belgian Agency of Health Insurance Funds on drug use of patients hospitalized in acute hospitals. Reimbursed drugs received in ambulatory care during the 3 months prior to hospitalization were compared with drugs received during the 3 months following hospital discharge. Both a narrow definition and a broad definition were used for drug substitution. Narrow substitution (switches between generic and originator drugs) was computed for 14 drug classes for chronic conditions with the highest public expenditure. Broad substitution (changes between chemical substances within the drug class at ATC level 4, changes in brand name) was calculated for statins and proton-pump inhibitors only. The database included 17 764 patients (mean age 66 ± 17 years; 60% female). In 71% of cases an originator drug was received prior to and following hospitalization. A generic drug was received prior to and following hospitalization in 25% of cases. Some form of narrow substitution occurred in 4% of cases: a generic drug was replaced by an originator drug in 2% of cases and an originator drug was replaced by a generic drug in 2% of cases. Some form of broad substitution occurred in 25% of cases for proton-pump inhibitors and 13% of cases for statins. Hospitalization was not a trigger for changes between originator and generic versions of a drug. Broad substitution associated with a hospital stay was relatively limited for statins and proton-pump inhibitors. © 2013 Royal Pharmaceutical Society.

DOE Office of Scientific and Technical Information (OSTI.GOV)

Cheng, Jing-Jy; Flood, Paul E.; LePoire, David

In this report, the results generated by RESRAD-RDD version 2.01 are compared with those produced by RESRAD-RDD version 1.7 for different scenarios with different sets of input parameters. RESRAD-RDD version 1.7 is spreadsheet-driven, performing calculations with Microsoft Excel spreadsheets. RESRAD-RDD version 2.01 revamped version 1.7 by using command-driven programs designed with Visual Basic.NET to direct calculations with data saved in Microsoft Access database, and re-facing the graphical user interface (GUI) to provide more flexibility and choices in guideline derivation. Because version 1.7 and version 2.01 perform the same calculations, the comparison of their results serves as verification of both versions.more » The verification covered calculation results for 11 radionuclides included in both versions: Am-241, Cf-252, Cm-244, Co-60, Cs-137, Ir-192, Po-210, Pu-238, Pu-239, Ra-226, and Sr-90. At first, all nuclidespecific data used in both versions were compared to ensure that they are identical. Then generic operational guidelines and measurement-based radiation doses or stay times associated with a specific operational guideline group were calculated with both versions using different sets of input parameters, and the results obtained with the same set of input parameters were compared. A total of 12 sets of input parameters were used for the verification, and the comparison was performed for each operational guideline group, from A to G, sequentially. The verification shows that RESRAD-RDD version 1.7 and RESRAD-RDD version 2.01 generate almost identical results; the slight differences could be attributed to differences in numerical precision with Microsoft Excel and Visual Basic.NET. RESRAD-RDD version 2.01 allows the selection of different units for use in reporting calculation results. The results of SI units were obtained and compared with the base results (in traditional units) used for comparison with version 1.7. The comparison shows that RESRAD-RDD version 2.01 correctly reports calculation results in the unit specified in the GUI.« less

Generic Kalman Filter Software

NASA Technical Reports Server (NTRS)

Lisano, Michael E., II; Crues, Edwin Z.

2005-01-01

The Generic Kalman Filter (GKF) software provides a standard basis for the development of application-specific Kalman-filter programs. Historically, Kalman filters have been implemented by customized programs that must be written, coded, and debugged anew for each unique application, then tested and tuned with simulated or actual measurement data. Total development times for typical Kalman-filter application programs have ranged from months to weeks. The GKF software can simplify the development process and reduce the development time by eliminating the need to re-create the fundamental implementation of the Kalman filter for each new application. The GKF software is written in the ANSI C programming language. It contains a generic Kalman-filter-development directory that, in turn, contains a code for a generic Kalman filter function; more specifically, it contains a generically designed and generically coded implementation of linear, linearized, and extended Kalman filtering algorithms, including algorithms for state- and covariance-update and -propagation functions. The mathematical theory that underlies the algorithms is well known and has been reported extensively in the open technical literature. Also contained in the directory are a header file that defines generic Kalman-filter data structures and prototype functions and template versions of application-specific subfunction and calling navigation/estimation routine code and headers. Once the user has provided a calling routine and the required application-specific subfunctions, the application-specific Kalman-filter software can be compiled and executed immediately. During execution, the generic Kalman-filter function is called from a higher-level navigation or estimation routine that preprocesses measurement data and post-processes output data. The generic Kalman-filter function uses the aforementioned data structures and five implementation- specific subfunctions, which have been developed by the user on the basis of the aforementioned templates. The GKF software can be used to develop many different types of unfactorized Kalman filters. A developer can choose to implement either a linearized or an extended Kalman filter algorithm, without having to modify the GKF software. Control dynamics can be taken into account or neglected in the filter-dynamics model. Filter programs developed by use of the GKF software can be made to propagate equations of motion for linear or nonlinear dynamical systems that are deterministic or stochastic. In addition, filter programs can be made to operate in user-selectable "covariance analysis" and "propagation-only" modes that are useful in design and development stages.

CASPER Version 2.0

NASA Technical Reports Server (NTRS)

Chien, Steve; Rabideau, Gregg; Tran, Daniel; Knight, Russell; Chouinard, Caroline; Estlin, Tara; Gaines, Daniel; Clement, Bradley; Barrett, Anthony

2007-01-01

CASPER is designed to perform automated planning of interdependent activities within a system subject to requirements, constraints, and limitations on resources. In contradistinction to the traditional concept of batch planning followed by execution, CASPER implements a concept of continuous planning and replanning in response to unanticipated changes (including failures), integrated with execution. Improvements over other, similar software that have been incorporated into CASPER version 2.0 include an enhanced executable interface to facilitate integration with a wide range of execution software systems and supporting software libraries; features to support execution while reasoning about urgency, importance, and impending deadlines; features that enable accommodation to a wide range of computing environments that include various central processing units and random- access-memory capacities; and improved generic time-server and time-control features.

Ada Compiler Validation Summary Report: Certificate Number: 901129W1. 11096 Verdix Corporation, VADS Sequent Balance DYNIX 3.0, VAda-110-2323, Version 6.0, Sequent Balance 8000, DYNIX Version 3.0 (Host & Target).

DTIC Science & Technology

1991-08-01

90-09-25- VRX Ada COMPILER VALIDATION SUMMARY REPORT: Certificate Number: 901129W1.11096 Verdix Corporation VADS Sequent Balance DYNIX 3.0, VAda-1lO...8000, DYNIX Version 3.0 Target Computer System: Sequent Balance 8000, DYNIX Version 3.0 Customer Agreement Number: 90-09-25- VRX See Section 3.1 for any

Display management subsystem, version 1: A user's eye view

NASA Technical Reports Server (NTRS)

Parker, Dolores

1986-01-01

The structure and application functions of the Display Management Subsystem (DMS) are described. The DMS, a subsystem of the Transportable Applications Executive (TAE), was designed to provide a device-independent interface for an image processing and display environment. The system is callable by C and FORTRAN applications, portable to accommodate different image analysis terminals, and easily expandable to meet local needs. Generic applications are also available for performing many image processing tasks.

A case study in generic drug use: should there be risk adjustment in incentive payments for the use of generic medications?

PubMed

Walton, Surrey M; Rash, Christine; Lambert, Bruce L; Galanter, William L

2014-11-01

Encouraging generic drug use has reduced health care costs for payers and consumers, but the availability of therapeutically interchangeable medications or generic medications of choice is not equal across disease states. The extent to which systems of care are able to substitute with generics is not well understood.  To (a) define and measure the maximum generic rate (MGR) of currently prescribed drugs within an academic medical group in and (b) illustrate differences across drugs associated with selected underlying diseases.   Prescription claims data were examined from an academic medical group in Chicago, Illinois. Based on pharmacologic and therapeutic criteria, drugs were classified into 2 categories-potentially substitutable and not potentially substitutable-based on whether the drugs are branded forms of the same chemical entities that are available as generics or are therapeutically interchangeable with other medications that have different chemical compositions but the same mechanisms of action and potential efficacy. A medication was considered potentially substitutable if it (a) did not have a narrow therapeutic index as defined by the FDA; (b) did not belong to 1 of 6 protected classes of drugs in the Medicare D provisions; (c) was substitutable with a generic medication containing the same chemical entity; or (d) was therapeutically interchangeable with a therapeutically equivalent medication. MGR was defined as the percentage of prescriptions that could potentially be prescribed in generic form. This rate was examined overall and across drugs known to be associated with illustrative diseases including hypertension, diabetes mellitus, and obstructive lung diseases.   The MGR ranged from 100% for drugs used in hypertension to 26.7% for drugs used in obstructive lung diseases. The MGR was 83.6%.  Payers wishing to promote generic substitution should incorporate the potential for substitution of clinically appropriate generic medications as part of incentives for generic utilization to avoid unintended consequences of using a fixed target rate. A practical methodology for determining an MGR is offered.

Pose estimation of teeth through crown-shape matching

NASA Astrophysics Data System (ADS)

Mok, Vevin; Ong, Sim Heng; Foong, Kelvin W. C.; Kondo, Toshiaki

2002-05-01

This paper presents a technique for determining a tooth's pose given a dental plaster cast and a set of generic tooth models. The ultimate goal of pose estimation is to obtain information about the sizes and positions of the roots, which lie hidden within the gums, without the use of X-rays, CT or MRI. In our approach, the tooth of interest is first extracted from the 3D dental cast image through segmentation. 2D views are then generated from the extracted tooth and are matched against a target view generated from the generic model with known pose. Additional views are generated in the vicinity of the best view and the entire process is repeated until convergence. Upon convergence, the generic tooth is superimposed onto the dental cast to show the position of the root. The results of applying the technique to canines demonstrate the excellent potential of the algorithm for generic tooth fitting.

Assessing health-related quality of life in adolescents: some psychometric properties of the first Norwegian version of KINDL.

PubMed

Helseth, Sølvi; Lund, Thorleif

2005-06-01

The study presented in this paper is part of a larger Norwegian investigation among adolescents, where the overall aim is to develop methods to promote their quality of life (QoL), to discover risk factors or threats to adolescents' well-being, and finally to prevent the negative effects of such factors. An adequate generic health-related quality of life (HR-QoL) measure is therefore needed. However, only a limited number of well validated instruments that measure HR-QoL in adolescents exist, and to date only a few has been translated into Norwegian. The purpose of this study was therefore to examine some psychometric properties of the first Norwegian version of a simple, generic, German HR-QoL questionnaire for adolescents, KINDL. The instrument consists of 24-items, distributed in six subscales, which correspond to six domains of adolescents' HR-QoL. Based on a sample of 239 healthy adolescents, the internal consistency reliability is satisfactory for both the total scale and the subscales of 'Self-esteem and Family', fairly good for the 'Emotional' subscale, but lower for the subscales 'Physical', 'Friends' and 'School'. Factor analyses, which concerns construct validity, yielded interpretable solutions. The factor solutions at item level were interpreted to be in line with the original subscales, while factor analysis at subscale level indicated that a common QoL core is involved. To conclude, the Norwegian version of KINDL appears, in general, to be a psychometrically acceptable method of measuring HR-QoL in healthy adolescents. However, the alpha-values of some of the subscales are not optimal, and these scales should be used with caution in research and profession. Still KINDL-N is considered suitable for screening purposes in the public health area and especially within school-health care.

Modulation of habit formation by levodopa in Parkinson's disease.

PubMed

Marzinzik, Frank; Wotka, Johann; Wahl, Michael; Krugel, Lea K; Kordsachia, Catarina; Klostermann, Fabian

2011-01-01

Dopamine promotes the execution of positively reinforced actions, but its role for the formation of behaviour when feedback is unavailable remains open. To study this issue, the performance of treated/untreated patients with Parkinson's disease and controls was analysed in an implicit learning task, hypothesising dopamine-dependent adherence to hidden task rules. Sixteen patients on/off levodopa and fourteen healthy subjects engaged in a Go/NoGo paradigm comprising four equiprobable stimuli. One of the stimuli was defined as target which was first consistently preceded by one of the three non-target stimuli (conditioning), whereas this coupling was dissolved thereafter (deconditioning). Two task versions were presented: in a 'Go version', only the target cue required the execution of a button press, whereas non-target stimuli were not instructive of a response; in a 'NoGo version', only the target cue demanded the inhibition of the button press which was demanded upon any non-target stimulus. Levodopa influenced in which task version errors grew from conditioning to deconditioning: in unmedicated patients just as controls errors only rose in the NoGo version with an increase of incorrect responses to target cues. Contrarily, in medicated patients errors went up only in the Go version with an increase of response omissions to target cues. The error increases during deconditioning can be understood as a perpetuation of reaction tendencies acquired during conditioning. The levodopa-mediated modulation of this carry-over effect suggests that dopamine supports habit conditioning under the task demand of response execution, but dampens it when inhibition is required. However, other than in reinforcement learning, supporting dopaminergic actions referred to the most frequent, i. e., non-target behaviour. Since this is passive whenever selective actions are executed against an inactive background, dopaminergic treatment could in according scenarios contribute to passive behaviour in patients with Parkinson's disease.

Changing the cost of care for chronic myeloid leukemia: the availability of generic imatinib in the USA and the EU.

PubMed

Conti, Rena M; Padula, William V; Larson, Richard A

2015-04-01

Imatinib is an oral tyrosine kinase inhibitor and considered to be the most successful targeted anti-cancer agent yet developed given its substantial efficacy in treating chronic myeloid leukemia (CML) and other malignant diseases. In the USA and the European Union (EU), Novartis' composition of matter patent on imatinib will expire in 2016. The potential impact on health system spending levels for CML after generic imatinib becomes available is the subject of significant interest among stakeholders. The extent of the potential savings largely depends on whether and to what extent prices decline and use stays the same or even increases. These are also empirical questions since the likely spending implications following generic imatinib's availability are predicated on multiple factors: physicians' willingness to prescribe generic imatinib, molecule characteristics, and health system priorities. This article discusses each of these issues in turn. We then review their implications for the development of country-specific cost-effectiveness models to predict the implications for cost and quality of care from generic imatinib.

Changing the cost of care for chronic myeloid leukemia: the availability of generic imatinib in the USA and the EU

PubMed Central

Padula, William V.; Larson, Richard A.

2015-01-01

Imatinib is an oral tyrosine kinase inhibitor and considered to be the most successful targeted anti-cancer agent yet developed given its substantial efficacy in treating chronic myeloid leukemia (CML) and other malignant diseases. In the USA and the European Union (EU), Novartis’ composition of matter patent on imatinib will expire in 2016. The potential impact on health system spending levels for CML after generic imatinib becomes available is the subject of significant interest among stakeholders. The extent of the potential savings largely depends on whether and to what extent prices decline and use stays the same or even increases. These are also empirical questions since the likely spending implications following generic imatinib’s availability are predicated on multiple factors: physicians’ willingness to prescribe generic imatinib, molecule characteristics, and health system priorities. This article discusses each of these issues in turn. We then review their implications for the development of country-specific cost-effectiveness models to predict the implications for cost and quality of care from generic imatinib. PMID:25814091

The influence of targeted education on medication persistence and generic substitution among consumer-directed health care enrollees.

PubMed

Sedjo, Rebecca L; Cox, Emily R

2009-12-01

To evaluate an educational outreach among consumer-directed health plan (CDHP) enrollees on medication persistence and lower-cost generic substitution within four chronic medication therapies. A cross-sectional analysis using pharmacy claims data from a national employer group that began offering a CDHP in 2006 and implemented an educational outreach to some CDHP enrollees in 2007 was used. The intervention group was comprised of CDHP enrollees who received education outreach and was compared with CDHP enrollees without the educational outreach. Adjusted and unadjusted medication persistence and lower-cost generic substitutions were compared between groups. There was no difference in medication persistence between groups. CDHP enrollees with the educational outreach were more likely to have converted to lower-cost generic alternative antihypertensive medication compared with CDHP enrollees without the educational outreach (OR(adj)=29.82, 95 percent CI=4.41-201.93). Educational outreach directed to CDHP enrollees was associated with increases in lower-cost generic alternatives with no change in patients' chronic medication use. However, considerable opportunity exists to assist CDHP enrollees in making sound health care decisions.

Generic element processor (application to nonlinear analysis)

NASA Technical Reports Server (NTRS)

Stanley, Gary

1989-01-01

The focus here is on one aspect of the Computational Structural Mechanics (CSM) Testbed: finite element technology. The approach involves a Generic Element Processor: a command-driven, database-oriented software shell that facilitates introduction of new elements into the testbed. This shell features an element-independent corotational capability that upgrades linear elements to geometrically nonlinear analysis, and corrects the rigid-body errors that plague many contemporary plate and shell elements. Specific elements that have been implemented in the Testbed via this mechanism include the Assumed Natural-Coordinate Strain (ANS) shell elements, developed with Professor K. C. Park (University of Colorado, Boulder), a new class of curved hybrid shell elements, developed by Dr. David Kang of LPARL (formerly a student of Professor T. Pian), other shell and solid hybrid elements developed by NASA personnel, and recently a repackaged version of the workhorse shell element used in the traditional STAGS nonlinear shell analysis code. The presentation covers: (1) user and developer interfaces to the generic element processor, (2) an explanation of the built-in corotational option, (3) a description of some of the shell-elements currently implemented, and (4) application to sample nonlinear shell postbuckling problems.

Freedom of information applications as an "evergreening" tactic: Secretary, Department of Health and Ageing v iNOVA Pharmaceuticals (Australia) Pty Ltd (2010) 191 FCR 573; [2010] FCA 1442.

PubMed

Vines, Tim; Faunce, Thomas

2011-09-01

A recent decision of the Federal Court of Australia illustrates how patent-holding pharmaceutical companies are attempting to use Australia's Freedom of Information Act 1982 (Cth) to force Australian safety, quality and efficacy regulators to disclose whether generic competitors are attempting to enter the market. In Secretary, Department of Health and Ageing v iNova Pharmaceuticals (Australia) Pty Ltd (2010) 191 FCR 573; [2010] FCA 1442 a single judge of the Federal Court overturned a decision of the Administrative Appeals Tribunal (AAT) that would have compelled the Australian Therapeutic Goods Administration (TGA) to reveal whether they were in possession of an application to register generic versions of two iNova products: imiquimod and phentermine. In its justification to the AAT for refusing to confirm or deny the existence of any application, the TGA argued that to reveal the existence of such a document would prejudice the proper administration of the National Health Act 1953 (Cth) as it could compromise the listing of a generic on the Pharmaceutical Benefits Scheme. The AAT failed to appreciate the extent to which this revelation to a competitor would have undercut 2004 amendments to the Therapeutic Goods Act 1989 (Cth) that provided penalties for evergreening tactics involving TGA notifications to drug patent-holders and 2006 amendments to the Patents Act 1990 (Cth) which protected the right of generic manufacturers to "springboard". The decision of the Federal Court is one of the first to explore the use of freedom of information legislation by patent-holders as a potential "evergreening" technique to prolong royalties by marginalising generic competition. Because of the significant amounts of money involved in ensuring rapid market entry of low-cost generic products, the issue has considerable public health significance.

Benefits Assessment of Algorithmically Combining Generic High Altitude Airspace Sectors

NASA Technical Reports Server (NTRS)

Bloem, Michael; Gupta, Pramod; Lai, Chok Fung; Kopardekar, Parimal

2009-01-01

In today's air traffic control operations, sectors that have traffic demand below capacity are combined so that fewer controller teams are required to manage air traffic. Controllers in current operations are certified to control a group of six to eight sectors, known as an area of specialization. Sector combinations are restricted to occur within areas of specialization. Since there are few sector combination possibilities in each area of specialization, human supervisors can effectively make sector combination decisions. In the future, automation and procedures will allow any appropriately trained controller to control any of a large set of generic sectors. The primary benefit of this will be increased controller staffing flexibility. Generic sectors will also allow more options for combining sectors, making sector combination decisions difficult for human supervisors. A sector-combining algorithm can assist supervisors as they make generic sector combination decisions. A heuristic algorithm for combining under-utilized air space sectors to conserve air traffic control resources has been described and analyzed. Analysis of the algorithm and comparisons with operational sector combinations indicate that this algorithm could more efficiently utilize air traffic control resources than current sector combinations. This paper investigates the benefits of using the sector-combining algorithm proposed in previous research to combine high altitude generic airspace sectors. Simulations are conducted in which all the high altitude sectors in a center are allowed to combine, as will be possible in generic high altitude airspace. Furthermore, the algorithm is adjusted to use a version of the simplified dynamic density (SDD) workload metric that has been modified to account for workload reductions due to automatic handoffs and Automatic Dependent Surveillance Broadcast (ADS-B). This modified metric is referred to here as future simplified dynamic density (FSDD). Finally, traffic demand sets with increased air traffic demand are used in the simulations to capture the expected growth in air traffic demand by the mid-term.

Cross-cultural adaptation, reliability and validity of the Spanish version of the Quality of Life in Adult Cancer Survivors (QLACS) questionnaire: application in a sample of short-term survivors.

PubMed

Escobar, Antonio; Trujillo-Martín, Maria del Mar; Rueda, Antonio; Pérez-Ruiz, Elisabeth; Avis, Nancy E; Bilbao, Amaia

2015-11-16

The aim of this study was to validate the Quality of Life in Adult Cancer Survivors (QLACS) in short-term Spanish cancer survivor's patients. Patients with breast, colorectal or prostate cancer that had finished their initial cancer treatment 3 years before the beginning of this study completed QLACS, WHOQOL, Short Form-36, Hospital Anxiety and Depression Scale, EORTC-QLQ-BR23 and EQ-5D. Cultural adaptation was made based on established guidelines. Reliability was evaluated using internal consistency and test-retest. Convergent validity was studied by mean of Pearson's correlation coefficient. Structural validity was determined by a second-order confirmatory factor analysis (CFA) and Rasch analysis was used to assess the unidimensionality of the Generic and Cancer-specific scales. Cronbach's alpha were above 0.7 in all domains and summary scales. Test-retest coefficients were 0.88 for Generic and 0.82 for Cancer-specific summary scales. QLACS generic summary scale was correlated with other generic criterion measures, SF-36 MCS (r = - 0.74) and EQ-VAS (r = - 0.63). QLACS cancer-specific scale had lower values with the same constructs. CFA provided satisfactory fit indices in all cases. The RMSEA value was 0.061 and CFI and TLI values were 0.929 and 0.925, respectively. All factor loadings were higher than 0.40 and statistically significant (P < 0.001). Generic summary scale had eight misfitting items. In the remaining 20 items, the unidimensionality was supported. Cancer Specific summary scale showed four misfitting items, the remaining showed unidimensionality. The findings support the validity and reliability of QLACS questionnaire to be used in short-term cancer survivors.

In-Bore 3-T MR-guided Transrectal Targeted Prostate Biopsy: Prostate Imaging Reporting and Data System Version 2–based Diagnostic Performance for Detection of Prostate Cancer

PubMed Central

Tan, Nelly; Lin, Wei-Chan; Khoshnoodi, Pooria; Asvadi, Nazanin H.; Yoshida, Jeffrey; Margolis, Daniel J. A.; Lu, David S. K.; Wu, Holden; Lu, David Y.; Huang, Jaioti

2017-01-01

Purpose To determine the diagnostic yield of in-bore 3-T magnetic resonance (MR) imaging–guided prostate biopsy and stratify performance according to Prostate Imaging Reporting and Data System (PI-RADS) versions 1 and 2. Materials and Methods This study was HIPAA compliant and institution review board approved. In-bore 3-T MR-guided prostate biopsy was performed in 134 targets in 106 men who (a) had not previously undergone prostate biopsy, (b) had prior negative biopsy findings with increased prostate-specific antigen (PSA) level, or (c) had a prior history of prostate cancer with increasing PSA level. Clinical, diagnostic 3-T MR imaging was performed with in-bore guided prostate biopsy, and pathology data were collected. The diagnostic yields of MR-guided biopsy per patient and target were analyzed, and differences between biopsy targets with negative and positive findings were determined. Results of logistic regression and areas under the curve were compared between PI-RADS versions 1 and 2. Results Prostate cancer was detected in 63 of 106 patients (59.4%) and in 72 of 134 targets (53.7%) with 3-T MR imaging. Forty-nine of 72 targets (68.0%) had clinically significant cancer (Gleason score ≥ 7). One complication occurred (urosepsis, 0.9%). Patients who had positive target findings had lower apparent diffusion coefficient values (875 × 10−6 mm2/sec vs 1111 × 10−6 mm2/sec, respectively; P < .01), smaller prostate volume (47.2 cm3 vs 75.4 cm3, respectively; P < .01), higher PSA density (0.16 vs 0.10, respectively; P < .01), and higher proportion of PI-RADS version 2 category 3–5 scores when compared with patients with negative target findings. MR targets with PI-RADS version 2 category 2, 3, 4, and 5 scores had a positive diagnostic yield of three of 23 (13.0%), six of 31 (19.4%), 39 of 50 (78.0%), and 24 of 29 (82.8%) targets, respectively. No differences were detected in areas under the curve for PI-RADS version 2 versus 1. Conclusion In-bore 3-T MR-guided biopsy is safe and effective for prostate cancer diagnosis when stratified according to PI-RADS versions 1 and 2. ©RSNA, 2016 PMID:27861110

Health-related quality of life of Estonian adolescents: reliability and validity of the PedsQL™ 4.0 Generic Core Scales in Estonia.

PubMed

Viira, Roomet; Koka, Andre

2011-07-01

The main aim of this study was to examine the reliability and validity of the Pediatric Quality of Life Inventory™ 4.0 (PedsQL™ 4.0) Generic Core Scales among Estonian adolescents. Gender differences in health-related quality of life (HRQoL) were also investigated. The 654 adolescents (309 boys and 345 girls) aged 13-14 years (M age = 13.57 years, SD = 0.62) completed Estonian version of the PedsQL™ 4.0. Results of the confirmatory factor analysis for a five-factor model of the Estonian version of PedsQL™ 4.0 approached the criteria of acceptable fit after setting error covariance to be free between some of the items within physical health, emotional functioning and social functioning subscales. Cronbach's alpha coefficients exceeded the minimum criterion of 0.70 for all subscales except for days missed from school because of illness subscale. With regard to gender differences, consistent with previous studies, girls reported lower level on total score of HRQoL as well as its aspects of physical health, emotional functioning and psychosocial health. The present study revealed that after some modifications, the PedsQL™ 4.0 could be considered as suitable instrument to measure HRQoL among Estonian adolescents. © 2011 The Author(s)/Acta Paediatrica © 2011 Foundation Acta Paediatrica.

Generic extravehicular (EVA) and telerobot task primitives for analysis, design, and integration. Version 1.0: Reference compilation for the EVA and telerobotics communities

NASA Technical Reports Server (NTRS)

Smith, Jeffrey H.; Drews, Michael

1990-01-01

The results are described of an effort to establish commonality and standardization of generic crew extravehicular (crew-EVA) and telerobotic task analysis primitives used for the study of spaceborne operations. Although direct crew-EVA plans are the most visible output of spaceborne operations, significant ongoing efforts by a wide variety of projects and organizations also require tools for estimation of crew-EVA and telerobotic times. Task analysis tools provide estimates for input to technical and cost tradeoff studies. A workshop was convened to identify the issues and needs to establish a common language and syntax for task analysis primitives. In addition, the importance of such a syntax was shown to have precedence over the level to which such a syntax is applied. The syntax, lists of crew-EVA and telerobotic primitives, and the data base in diskette form are presented.

Concerns about the safety of obesity agents from a manufacturing perspective.

PubMed

Kanfer, Isadore

2008-07-01

Salt derivatives of active pharmaceutical ingredients (API), such as hydrochloride and mesylate salts, are frequently used during drug product development. Compared with the underivatized API, salt derivatives are often associated with beneficial properties, including improved solubility and better absorption. Although the obesity agent sibutramine was initially approved as the hydrochloride salt, it has also been formulated as a mesylate salt (sibutramine mesylate). In order to qualify as interchangeable, generic products generally must be both pharmaceutically equivalent and bioequivalent to an approved reference product. Because generic versions of hydrochloride salt formulations that have been reformulated as mesylate salts are not pharmaceutically equivalent to the approved reference products, they would not be interchangeable, even if bioequivalent. The safety of APIs and drug products manufactured outside the United States in non-Food and Drug Administration-regulated facilities are of concern, particularly agents that may contain harmful impurities, such as obesity products formulated as mesylate salts.

Au pairs are rarely male: norms on the gender perception of role names across English, French, and German.

PubMed

Gabriel, Ute; Gygax, Pascal; Sarrasin, Oriane; Garnham, Alan; Oakhill, Jane

2008-02-01

A list of role names for future use in research on gender stereotyping was created and evaluated. In two studies, 126 role names were rated with reference to their gender stereotypicality by English-, French-, and German-speaking students of universities in Switzerland (French and German) and in the U.K. (English). Role names were either presented in specific feminine and masculine forms (Study 1) or in the masculine form (generic masculine) only (Study 2). The rankings of the stereotypicality ratings were highly reliable across languages and questionnaire versions, but the overall mean of the ratings was less strongly male if participants were also presented with the female versions of the role names and if the latter were presented on the left side of the questionnaires.

Tool for Rapid Analysis of Monte Carlo Simulations

NASA Technical Reports Server (NTRS)

Restrepo, Carolina; McCall, Kurt E.; Hurtado, John E.

2013-01-01

Designing a spacecraft, or any other complex engineering system, requires extensive simulation and analysis work. Oftentimes, the large amounts of simulation data generated are very difficult and time consuming to analyze, with the added risk of overlooking potentially critical problems in the design. The authors have developed a generic data analysis tool that can quickly sort through large data sets and point an analyst to the areas in the data set that cause specific types of failures. The first version of this tool was a serial code and the current version is a parallel code, which has greatly increased the analysis capabilities. This paper describes the new implementation of this analysis tool on a graphical processing unit, and presents analysis results for NASA's Orion Monte Carlo data to demonstrate its capabilities.

Learning Probabilities From Random Observables in High Dimensions: The Maximum Entropy Distribution and Others

NASA Astrophysics Data System (ADS)

Obuchi, Tomoyuki; Cocco, Simona; Monasson, Rémi

2015-11-01

We consider the problem of learning a target probability distribution over a set of N binary variables from the knowledge of the expectation values (with this target distribution) of M observables, drawn uniformly at random. The space of all probability distributions compatible with these M expectation values within some fixed accuracy, called version space, is studied. We introduce a biased measure over the version space, which gives a boost increasing exponentially with the entropy of the distributions and with an arbitrary inverse `temperature' Γ . The choice of Γ allows us to interpolate smoothly between the unbiased measure over all distributions in the version space (Γ =0) and the pointwise measure concentrated at the maximum entropy distribution (Γ → ∞ ). Using the replica method we compute the volume of the version space and other quantities of interest, such as the distance R between the target distribution and the center-of-mass distribution over the version space, as functions of α =(log M)/N and Γ for large N. Phase transitions at critical values of α are found, corresponding to qualitative improvements in the learning of the target distribution and to the decrease of the distance R. However, for fixed α the distance R does not vary with Γ which means that the maximum entropy distribution is not closer to the target distribution than any other distribution compatible with the observable values. Our results are confirmed by Monte Carlo sampling of the version space for small system sizes (N≤ 10).

Perception and attitude of general practitioners regarding generic medicines in Karachi, Pakistan: A questionnaire based study

PubMed Central

Jamshed, Shazia Qasim; Ibrahim, Mohamed Izham Mohamed; Hassali, Mohamed Azmi Ahmad; Masood, Imran; Low, Bee Yean; Shafie, Asrul Akmal; Babar, Zaheer-ud-din

2012-01-01

Objectives: In developing countries out-of-pocket payments (OOP) are as high as 80% of healthcare spending. Generic medicines can be instrumental in reducing this expenditure. The current study is aimed to explore the knowledge, perception, and attitude of general practitioners towards generic medicines in Karachi, Pakistan. Methods: This exploratory, descriptive study was conducted on a sample of 289 randomly selected general practitioners who were dispensing at their private clinics in Karachi, Pakistan. The questionnaires were distributed and collected by hand. Data was entered to SPSS version 17. Fischer’s exact test was applied to see the association between variables. Results: A total of 206 questionnaires were included in the study. A response rate of 71.3% was achieved. Out of 206 respondents, 139 (67.5%) were male while 67 (32.5%) respondents were female. Close to three quaters of the respondents (n= 148; 71.8%) showed correct knowledge about generic medicines being a ‘copy of the brand name medicines’ and ‘interchangeable with brand name medicines’ (n= 148; 71.8%). In terms of safety, the majority of respondents (n=85; 41.26%) incorrectly understood that the generic medicines are less safe than brand name medicines. The total percentage of correct responses was seen in 53% of the respondents. More than half of the respondents agreed that locally manufactured medicines are of the same effectiveness as brand name medicines (n=114; 55.4%). Male practitioners with practice experience of 11-15 years showed positive perception towards the quality of multinational products. The Majority of respondents believed that their prescribing decision is influenced by medical representatives (n=117; 56.8%). More than three-quarters of the respondents expressed their wish to prescribe low cost medicines in their practice (n=157; 76.2%). More than one third of the respondents expressed their uneasiness to prescribe products from all local manufacturers (n=72; 35%). Conclusion: There were gaps identified in the knowledge of respondents. Although good perception and attitude were noted among the respondents, dissemination of information regarding generic medicines may perhaps strengthen generic prescribing. There is a need to introduce ‘Quality by Design’ concept in local manufacturing units. This, in turn, can inculcate confidence in prescribers towards locally manufactured generic medicines. PMID:23093896

Generic framework for vessel detection and tracking based on distributed marine radar image data

NASA Astrophysics Data System (ADS)

Siegert, Gregor; Hoth, Julian; Banyś, Paweł; Heymann, Frank

2018-04-01

Situation awareness is understood as a key requirement for safe and secure shipping at sea. The primary sensor for maritime situation assessment is still the radar, with the AIS being introduced as supplemental service only. In this article, we present a framework to assess the current situation picture based on marine radar image processing. Essentially, the framework comprises a centralized IMM-JPDA multi-target tracker in combination with a fully automated scheme for track management, i.e., target acquisition and track depletion. This tracker is conditioned on measurements extracted from radar images. To gain a more robust and complete situation picture, we are exploiting the aspect angle diversity of multiple marine radars, by fusing them a priori to the tracking process. Due to the generic structure of the proposed framework, different techniques for radar image processing can be implemented and compared, namely the BLOB detector and SExtractor. The overall framework performance in terms of multi-target state estimation will be compared for both methods based on a dedicated measurement campaign in the Baltic Sea with multiple static and mobile targets given.

The PedsQL™ Oral Health Scale: feasibility, reliability and validity of the Brazilian Portuguese version

PubMed Central

2012-01-01

Background Oral and orofacial problems may cause a profound impact on children’s oral health-related quality of life (OHRQoL) because of symptoms associated with these conditions that may influence the physical, psychological and social aspects of their daily life. The OHRQoL questionnaires found in the literature are very specific and are not able to measure the impact of oral health on general health domains. Consequently, the objective of this study was to evaluate the psychometric properties of the Portuguese version for Brazilian translation of the Pediatric Quality of Life Inventory™ (PedsQL™) Oral Health Scale in combination with the PedsQL™ 4.0 Generic Core Scales. Methods The PedsQL™ Oral Health Scale was forward-backward translated and cross-culturally adapted for the Brazilian Portuguese language. In order to assess the feasibility, reliability and validity of the Brazilian version of the instrument, a study was carried out in Belo Horizonte with 208 children and adolescents between 2 and 18 years-of-age and their parents. Clinical evaluation of dental caries, socioeconomic information and the Brazilian versions of the PedsQL™ Oral Health Scale, PedsQL™ 4.0 Generic Core Scales, Child Perceptions Questionnaire (CPQ11-14 and CPQ8-10) and Parental-Caregiver Perception Questionnaire (P-CPQ) were administered. Statistical analysis included feasibility (missing values), confirmatory factor analysis (CFA), internal consistency reliability, and test-retest intraclass correlation coefficients (ICC) of the PedsQL™ Oral Health Scale. Results There were no missing data for both child self-report and parent proxy-report on the Brazilian version of the PedsQL™ Oral Health Scale. The CFA showed that the five items of child self-report and parent proxy-report loaded on a single construct. The Cronbach's alpha coefficients for child/adolescent and parent oral health instruments were 0.65 and 0.59, respectively. The test-retest reliability (ICC) for child self-report and parent proxy-report were 0.90 [95% confidence interval (CI) = 0.86-0.93] and 0.86 (95%CI = 0.81-0.90), respectively. The PedsQL™ Oral Health Scale demonstrated acceptable construct validity, convergent validity and discriminant validity. Conclusions These results supported the feasibility, reliability and validity of the Brazilian version of the PedsQL™ Oral Health Scale for child self-report for ages 5–18 years-old and parent proxy-report for ages 2–18 years-old children. PMID:22531004

AEOSS runtime manual for system analysis on Advanced Earth-Orbital Spacecraft Systems

NASA Technical Reports Server (NTRS)

Lee, Hwa-Ping

1990-01-01

Advanced earth orbital spacecraft system (AEOSS) enables users to project the required power, weight, and cost for a generic earth-orbital spacecraft system. These variables are calculated on the component and subsystem levels, and then the system level. The included six subsystems are electric power, thermal control, structure, auxiliary propulsion, attitude control, and communication, command, and data handling. The costs are computed using statistically determined models that were derived from the flown spacecraft in the past and were categorized into classes according to their functions and structural complexity. Selected design and performance analyses for essential components and subsystems are also provided. AEOSS has the feature permitting a user to enter known values of these parameters, totally and partially, at all levels. All information is of vital importance to project managers of subsystems or a spacecraft system. AEOSS is a specially tailored software coded from the relational database program of the Acius' 4th Dimension with a Macintosh version. Because of the licensing agreements, two versions of the AEOSS documents were prepared. This version, AEOSS Runtime Manual, is permitted to be distributed with a finite number of the restrictive 4D Runtime version. It can perform all contained applications without any programming alterations.

Spacecraft Trajectory Analysis and Mission Planning Simulation (STAMPS) Software

NASA Technical Reports Server (NTRS)

Puckett, Nancy; Pettinger, Kris; Hallstrom,John; Brownfield, Dana; Blinn, Eric; Williams, Frank; Wiuff, Kelli; McCarty, Steve; Ramirez, Daniel; Lamotte, Nicole;

Selective Transfer Machine for Personalized Facial Action Unit Detection

PubMed Central

Chu, Wen-Sheng; De la Torre, Fernando; Cohn, Jeffery F.

2014-01-01

Automatic facial action unit (AFA) detection from video is a long-standing problem in facial expression analysis. Most approaches emphasize choices of features and classifiers. They neglect individual differences in target persons. People vary markedly in facial morphology (e.g., heavy versus delicate brows, smooth versus deeply etched wrinkles) and behavior. Individual differences can dramatically influence how well generic classifiers generalize to previously unseen persons. While a possible solution would be to train person-specific classifiers, that often is neither feasible nor theoretically compelling. The alternative that we propose is to personalize a generic classifier in an unsupervised manner (no additional labels for the test subjects are required). We introduce a transductive learning method, which we refer to Selective Transfer Machine (STM), to personalize a generic classifier by attenuating person-specific biases. STM achieves this effect by simultaneously learning a classifier and re-weighting the training samples that are most relevant to the test subject. To evaluate the effectiveness of STM, we compared STM to generic classifiers and to cross-domain learning methods in three major databases: CK+ [20], GEMEP-FERA [32] and RU-FACS [2]. STM outperformed generic classifiers in all. PMID:25242877

The Influence of Targeted Education on Medication Persistence and Generic Substitution among Consumer-Directed Health Care Enrollees

PubMed Central

Sedjo, Rebecca L; Cox, Emily R

2009-01-01

Objective To evaluate an educational outreach among consumer-directed health plan (CDHP) enrollees on medication persistence and lower-cost generic substitution within four chronic medication therapies. Study Setting A cross-sectional analysis using pharmacy claims data from a national employer group that began offering a CDHP in 2006 and implemented an educational outreach to some CDHP enrollees in 2007 was used. Methods The intervention group was comprised of CDHP enrollees who received education outreach and was compared with CDHP enrollees without the educational outreach. Adjusted and unadjusted medication persistence and lower-cost generic substitutions were compared between groups. Principal Findings There was no difference in medication persistence between groups. CDHP enrollees with the educational outreach were more likely to have converted to lower-cost generic alternative antihypertensive medication compared with CDHP enrollees without the educational outreach (ORadj=29.82, 95 percent CI=4.41–201.93). Conclusion Educational outreach directed to CDHP enrollees was associated with increases in lower-cost generic alternatives with no change in patients' chronic medication use. However, considerable opportunity exists to assist CDHP enrollees in making sound health care decisions. PMID:19780849

Effects of Non-Normal Outlier-Prone Error Distribution on Kalman Filter Track

DTIC Science & Technology

1991-09-01

other possibilities exist. For example the GST (Generic Statistical Tracker) uses four motion models [Ref. 41. The GST keeps track of both the target...1.011 + + + 3.113 1.291 4 Although this procedure is not easily statistically interpretable, it was used for the sake of comparison with the other... TRANSITOR TARGET’ WRITE(6,*)’ 3 SECOND ORDER GAUSS MARKOV TARGET’ WRITE(6,*)’ 4 RANDOM TOUR TARGET’ READ(6,*) CHOICE IF((CHOICE.LT.1).OR.(CHOICE.GT.4

The role of attention during retrieval in working-memory span: a dual-task study.

PubMed

Healey, M Karl; Miyake, Akira

2009-04-01

We tested the hypothesis that retrieving target words in operation span (OSpan) involves attention-demanding processes. Participants completed the standard OSpan task and a modified version in which all equations preceded all target words. Recall took place under either full attention or easy versus hard divided-attention conditions. Recall suffered under divided attention with the recall decrement being greater for the hard secondary task. Moreover, secondary-task performance was disrupted more by the standard OSpan task than by the modified version with the hard secondary task showing the larger decrement. Finally, the time taken to start recalling the first word was considerably longer for the standard version than for the modified version. These results are consistent with the proposal that successful OSpan task performance in part involves the attention-demanding retrieval of targets from long-term memory.

BRITE-PL: the first Polish scientific satellite

NASA Astrophysics Data System (ADS)

Orleanski, Piotr; Graczyk, Rafal; Rataj, Miroslaw; Schwarzenberg-Czerny, Aleksander; Zawistowski, Tomasz; Zee, Robert E.

2010-09-01

The participation in BRITE Consortium gives Poland the possibility to launch into space the first Polish scientific satellite. This paper presents the Polish technical contribution to the BRITE Program to be realized in two institutes of the Polish Academy of Sciences: Nicolaus Copernicus Astronomical Center and Space Research Center.. BRITE Constellation, short for "BRIght Target Explorer Constellation," is a group of up to six nano-satellites whose purpose is to photometrically measure low-level oscillations and temperature variations in the sky's 286 stars brighter than visual magnitude 3.5, with unprecedented precision and time sampling not achievable through terrestrial-based methods. The three-axis pointing performance (1 arc minute rms stability) of each BRITE satellite is a significant advancement over anything that has ever flown before on a nano-satellite and is an important factor that enables the high precision photometry mission. The paper summarizes the technical details of the BRITE satellite based on Generic Nanosatellite Bus from SFL/UTIAS. The first Polish satellite, BRITE -PL 1, will be a modified version of the original SFL design. The second Polish satellite, BRITE-PL 2, will include the significant changes to be implemented by SRC PAS.

Using the Hemophilia Joint Health Score for assessment of children: Reliability of the Spanish version.

PubMed

R, Cuesta-Barriuso; A, Torres-Ortuño; S, Pérez-Alenda; J, Carrasco Juan; F, Querol; J, Nieto-Munuera; Ja, López-Pina

2018-02-27

Numerous measuring instruments for the evaluation of hemophilic arthropathy have been developed. One of the most used systems is the Hemophilia Joint Health Score (HJHS) given its sensitivity to clinical changes appearing in the joints because of recurrent hemarthrosis. Assessing the interrater reliability, using the Spanish version of the HJHS (version 2.1) in children with hemophilia. Reliability study to assess the interrater reliability of the Spanish version of HJHS. A sample of 36 children aged 7-13 years diagnosed with hemophilia A or B was used. Two physiotherapists performed physical assessments with the Spanish version of the HJHS. Descriptive statistics (range, mean, standard deviation) and the analysis of interrater reliability were calculated. The interrater reliability was heterogeneous since the Kappa coefficient range (ĸ), although significant (p < 0.001), ranged 0.31-1.00 in the variables of HJHS (swelling, duration of swelling, muscle atrophy, crepitus on motion, flexion loss, extension loss, joint pain, strength, and global gait). In assessing the bias of observers with the Bland and Altman method, the observer 1 scored 0.41 (CI [-0.67, 1.49]) units above observer 2, and the difference between the two was significant (t(36) = 4.48), p < 0.001). The interrater reliability of the Spanish population version of the HJHS is high. This scale should be used generically in evaluating musculoskeletal pediatric patients with hemophilia.

Knowledge and perceptions of physicians from private medical centres towards generic medicines: a nationwide survey from Malaysia.

PubMed

Kumar, Rohit; Hassali, Mohamed Azmi; Saleem, Fahad; Alrasheedy, Alian A; Kaur, Navneet; Wong, Zhi Yen; Kader, Muhamad Ali Sk Abdul

2015-01-01

Generic medicine prescribing has become a common practice in public hospitals. However, the trend in private medical centres seems to be different. The objective of this study was to investigate knowledge, perceptions and behavior of physicians from private medical centres in Malaysia regarding generic medicines. This study was a cross-sectional nationwide survey targeting physicians from private medical centres in Malaysia. The survey was conducted using questionnaire having (i) background and demographic data of the physicians, volume of prescription in a day, stock of generic medicines in their hospital pharmacy etc. (ii) their knowledge about bioequivalence (iii) prescribing behavior (iv) physicians' knowledge of quality, safety and efficacy of generic medicines, and their cost (v) perceptions of physicians towards issues pertaining to generic medicines utilization. A total of 263 questionnaires out of 735 were received, giving a response rate of 35.8%. Of the respondents, 214 (81.4%) were male and 49 (18.6%) were females. The majority of the participants were in the age range of 41-50 years and comprised 49.0% of the respondents. Only 2.3% of physicians were aware of the regulatory limits of bioequivalence standards in Malaysia. Of the respondents, 23.2% agreed that they 'always' write their prescriptions using originator product name whereas 50.2% do it 'usually'. A number of significant associations were found between their knowledge, perceptions about generic medicines and their demographic characteristics. The majority of the physicians from private medical centres in Malaysia had negative perceptions about safety, quality and the efficacy of generic medicines. These negative perceptions could be the cause of the limited use of generic medicines in the private medical centres. Therefore, in order to facilitate their use, it is recommended that the physicians need to be reassured and educated about the drug regulatory authority approval system of generic medicines with regard to their bioequivalence, quality, efficacy and safety. Apart from the policy on generic substitution, it would also be recommended to have a national medicine pricing policy, which controls drug prices, in both the public and private sector. These efforts are worthwhile to reduce the drug expenditure and improve the medicine affordability in Malaysia.

Towards a Generic and Adaptive System-On-Chip Controller for Space Exploration Instrumentation

NASA Technical Reports Server (NTRS)

Iturbe, Xabier; Keymeulen, Didier; Yiu, Patrick; Berisford, Dan; Hand, Kevin; Carlson, Robert; Ozer, Emre

2015-01-01

This paper introduces one of the first efforts conducted at NASA’s Jet Propulsion Laboratory (JPL) to develop a generic System-on-Chip (SoC) platform to control science instruments that are proposed for future NASA missions. The SoC platform is named APEX-SoC, where APEX stands for Advanced Processor for space Exploration, and is based on a hybrid Xilinx Zynq that combines an FPGA and an ARM Cortex-A9 dual-core processor on a single chip. The Zynq implements a generic and customizable on-chip infrastructure that can be reused with a variety of instruments, and it has been coupled with a set of off-chip components that are necessary to deal with the different instruments. We have taken JPL’s Compositional InfraRed Imaging Spectrometer (CIRIS), which is proposed for NASA icy moons missions, as a use-case scenario to demonstrate that the entire data processing, control and interface of an instrument can be implemented on a single device using the on-chip infrastructure described in this paper. We show that the performance results achieved in this preliminary version of the instrumentation controller are sufficient to fulfill the science requirements demanded to the CIRIS instrument in future NASA missions, such as Europa.

Early Impact Of The Affordable Care Act On Oral Contraceptive Cost Sharing, Discontinuation, And Nonadherence.

PubMed

Pace, Lydia E; Dusetzina, Stacie B; Keating, Nancy L

2016-09-01

The oral contraceptive pill is the contraceptive method most commonly used by US women, but inconsistent use of the pill is a contributor to high rates of unintended pregnancy. The relationship between consumer cost sharing and consistent use of the pill is not well understood, and the impact of the elimination of cost sharing for oral contraceptive pills in a mandate in the Affordable Care Act (ACA) is not yet known. We analyzed insurance claims for 635,075 women with employer-sponsored insurance who were initiating use of the pill, to examine rates of discontinuation and nonadherence, their relationship with cost sharing, and trends before and during the first year after implementation of the ACA mandate. We found that cost sharing for oral contraceptives decreased markedly following implementation, more significantly for generic than for brand-name versions. Higher copays were associated with greater discontinuation of and nonadherence to generic pills than was the case with zero copayments. Discontinuation of the use of generic or brand-name pills decreased slightly but significantly following ACA implementation, as did nonadherence to brand-name pills. Our findings suggest a modest early impact of the ACA on improving consistent use of oral contraceptives among women initiating their use. Project HOPE—The People-to-People Health Foundation, Inc.

Floquet-Magnus theory and generic transient dynamics in periodically driven many-body quantum systems

NASA Astrophysics Data System (ADS)

Kuwahara, Tomotaka; Mori, Takashi; Saito, Keiji

2016-04-01

This work explores a fundamental dynamical structure for a wide range of many-body quantum systems under periodic driving. Generically, in the thermodynamic limit, such systems are known to heat up to infinite temperature states in the long-time limit irrespective of dynamical details, which kills all the specific properties of the system. In the present study, instead of considering infinitely long-time scale, we aim to provide a general framework to understand the long but finite time behavior, namely the transient dynamics. In our analysis, we focus on the Floquet-Magnus (FM) expansion that gives a formal expression of the effective Hamiltonian on the system. Although in general the full series expansion is not convergent in the thermodynamics limit, we give a clear relationship between the FM expansion and the transient dynamics. More precisely, we rigorously show that a truncated version of the FM expansion accurately describes the exact dynamics for a certain time-scale. Our theory reveals an experimental time-scale for which non-trivial dynamical phenomena can be reliably observed. We discuss several dynamical phenomena, such as the effect of small integrability breaking, efficient numerical simulation of periodically driven systems, dynamical localization and thermalization. Especially on thermalization, we discuss a generic scenario on the prethermalization phenomenon in periodically driven systems.

Adapting the coping in deliberation (CODE) framework: a multi-method approach in the context of familial ovarian cancer risk management.

PubMed

Witt, Jana; Elwyn, Glyn; Wood, Fiona; Rogers, Mark T; Menon, Usha; Brain, Kate

2014-11-01

To test whether the coping in deliberation (CODE) framework can be adapted to a specific preference-sensitive medical decision: risk-reducing bilateral salpingo-oophorectomy (RRSO) in women at increased risk of ovarian cancer. We performed a systematic literature search to identify issues important to women during deliberations about RRSO. Three focus groups with patients (most were pre-menopausal and untested for genetic mutations) and 11 interviews with health professionals were conducted to determine which issues mattered in the UK context. Data were used to adapt the generic CODE framework. The literature search yielded 49 relevant studies, which highlighted various issues and coping options important during deliberations, including mutation status, risks of surgery, family obligations, physician recommendation, peer support and reliable information sources. Consultations with UK stakeholders confirmed most of these factors as pertinent influences on deliberations. Questions in the generic framework were adapted to reflect the issues and coping options identified. The generic CODE framework was readily adapted to a specific preference-sensitive medical decision, showing that deliberations and coping are linked during deliberations about RRSO. Adapted versions of the CODE framework may be used to develop tailored decision support methods and materials in order to improve patient-centred care. Copyright © 2014 Elsevier Ireland Ltd. All rights reserved.

Manual for a workstation-based generic flight simulation program (LaRCsim), version 1.4

NASA Technical Reports Server (NTRS)

Jackson, E. Bruce

1995-01-01

LaRCsim is a set of ANSI C routines that implement a full set of equations of motion for a rigid-body aircraft in atmospheric and low-earth orbital flight, suitable for pilot-in-the-loop simulations on a workstation-class computer. All six rigid-body degrees of freedom are modeled. The modules provided include calculations of the typical aircraft rigid-body simulation variables, earth geodesy, gravity and atmospheric models, and support several data recording options. Features/limitations of the current version include English units of measure, a 1962 atmosphere model in cubic spline function lookup form, ranging from sea level to 75,000 feet, rotating oblate spheroidal earth model, with aircraft C.G. coordinates in both geocentric and geodetic axes. Angular integrations are done using quaternion state variables Vehicle X-Z symmetry is assumed.

The linguistic validation of Russian version of Dutch four-dimensional symptoms questionnaire (4DSQ) for assessing distress, depression, anxiety and somatization in patients with borderline psychosomatic disorders.

PubMed

Arnautov, V S; Reyhart, D V; Smulevich, A B; Yakhno, N N; Terluin, B; Zakharova, E K; Andryushchenko, A V; Parfenov, V A; Zamergrad, M V; Romanov, D V

2015-12-12

The four-dimensional symptom questionnaire (4DSQ) is an originally Dutch self-report questionnaire that has been developed in primary care to distinguish non-specific general distress from depression, anxiety and somatization. In order to produce the appropriate translated Russian version the process of linguistic validation has been initiated. This process has been done according to the "Linguistic Validation Manual for Health Outcome Assessments" developed by MAPI institute. To produce the appropriate Russian version of the 4DSQ that is conceptually and linguistically equivalent to the original questionnaire. The original Dutch version of the 4DSQ was translated by one translator into Russian. The validated English version of the 4DSQ was translated by another translator into Russian without mutual consultation. The consensus version was created based on two translated versions. After that the back translation was performed to Dutch, some changes were implemented to the consensus Russian version and the second target version was developed based on these results. The second target version was sent to an appropriate group of reviewers. Based on their comments, the second target version was updated. After wards this version was tested in patients during cognitive interview. The study protocol was approved by the Independent Interdisciplinary Ethics Committee on Ethical Review for Clinical Studies, and in compliance with the Helsinki Declaration and ICH-GCP guidelines and local regulations. Enrolled patients provided written informed consent. After the process of forward and backward translation, consultant and developer's comments, clinicians and cognitive review the final version of Russian 4DSQ was developed for assessment of distress, depression, anxiety and somatization. The Russian 4DSQ as a result of translation procedures and cognitive interviews linguistically corresponds to the original Dutch 4DSQ and could be assessed in psychometric validation for the further using in general practice.

Cross-cultural adaptation and validation of the Korean version of the EQ-5D in patients with rheumatic diseases.

PubMed

Kim, Myoung-Hee; Cho, Young-Shin; Uhm, Wan-Sik; Kim, Sehyun; Bae, Sang-Cheol

2005-06-01

This study aimed to determine the cross-cultural adaptation and validation of the Korean version of the EQ-5D in rheumatic conditions. Translation, back-translation and cognitive debriefing were performed according to the EuroQol group's guidelines. For validity, 508 patients were recruited and administered the EQ-5D, Short-Form 36 and condition-specific measures. Construct validity and sensitivity were evaluated by testing a-priori hypotheses. For reliability, another 57 patients repeated the EQ-5D at 1-week interval, and intra-class correlations (ICC) and kappa statistics were estimated. For responsiveness, another 60 patients repeated it at 12-week interval within the context of clinical trial, and standardized response mean(SRM) were calculated. The cross-cultural adaptation produced no major modifications in the scale. The associations of the EQ-5D with the generic- and condition-specific measures were observed as expected in hypotheses: the higher EQ-5Dindex and EQ-5D(VAS) scores, the better health status by generic- or condition-specific measures, and the better functional class. The ICCs were 0.751 and 0.767, respectively, and kappa ranged from 0.455 to 0.772. The SRM were 0.649 and 0.410, respectively. The Korean EQ-5D exhibits good validity and sensitivity in various rheumatic conditions. Although its reliability and responsiveness were not excellent, it seems acceptable if condition-specific measures are applied together.

The analysis of a generic air-to-air missile simulation model

NASA Technical Reports Server (NTRS)

Kaplan, Joseph A.; Chappell, Alan R.; Mcmanus, John W.

1994-01-01

A generic missile model was developed to evaluate the benefits of using a dynamic missile fly-out simulation system versus a static missile launch envelope system for air-to-air combat simulation. This paper examines the performance of a launch envelope model and a missile fly-out model. The launch envelope model bases its probability of killing the target aircraft on the target aircraft's position at the launch time of the weapon. The benefits gained from a launch envelope model are the simplicity of implementation and the minimal computational overhead required. A missile fly-out model takes into account the physical characteristics of the missile as it simulates the guidance, propulsion, and movement of the missile. The missile's probability of kill is based on the missile miss distance (or the minimum distance between the missile and the target aircraft). The problems associated with this method of modeling are a larger computational overhead, the additional complexity required to determine the missile miss distance, and the additional complexity of determining the reason(s) the missile missed the target. This paper evaluates the two methods and compares the results of running each method on a comprehensive set of test conditions.

Design and Analysis of Architectures for Structural Health Monitoring Systems

NASA Technical Reports Server (NTRS)

Mukkamala, Ravi; Sixto, S. L. (Technical Monitor)

2002-01-01

During the two-year project period, we have worked on several aspects of Health Usage and Monitoring Systems for structural health monitoring. In particular, we have made contributions in the following areas. 1. Reference HUMS architecture: We developed a high-level architecture for health monitoring and usage systems (HUMS). The proposed reference architecture is shown. It is compatible with the Generic Open Architecture (GOA) proposed as a standard for avionics systems. 2. HUMS kernel: One of the critical layers of HUMS reference architecture is the HUMS kernel. We developed a detailed design of a kernel to implement the high level architecture.3. Prototype implementation of HUMS kernel: We have implemented a preliminary version of the HUMS kernel on a Unix platform.We have implemented both a centralized system version and a distributed version. 4. SCRAMNet and HUMS: SCRAMNet (Shared Common Random Access Memory Network) is a system that is found to be suitable to implement HUMS. For this reason, we have conducted a simulation study to determine its stability in handling the input data rates in HUMS. 5. Architectural specification.

Study of fault tolerant software technology for dynamic systems

NASA Technical Reports Server (NTRS)

Caglayan, A. K.; Zacharias, G. L.

1985-01-01

The major aim of this study is to investigate the feasibility of using systems-based failure detection isolation and compensation (FDIC) techniques in building fault-tolerant software and extending them, whenever possible, to the domain of software fault tolerance. First, it is shown that systems-based FDIC methods can be extended to develop software error detection techniques by using system models for software modules. In particular, it is demonstrated that systems-based FDIC techniques can yield consistency checks that are easier to implement than acceptance tests based on software specifications. Next, it is shown that systems-based failure compensation techniques can be generalized to the domain of software fault tolerance in developing software error recovery procedures. Finally, the feasibility of using fault-tolerant software in flight software is investigated. In particular, possible system and version instabilities, and functional performance degradation that may occur in N-Version programming applications to flight software are illustrated. Finally, a comparative analysis of N-Version and recovery block techniques in the context of generic blocks in flight software is presented.

Screening a fragment cocktail library using ultrafiltration

PubMed Central

Shibata, Sayaka; Zhang, Zhongsheng; Korotkov, Konstantin V.; Delarosa, Jaclyn; Napuli, Alberto; Kelley, Angela M.; Mueller, Natasha; Ross, Jennifer; Zucker, Frank H.; Buckner, Frederick S.; Merritt, Ethan A.; Verlinde, Christophe L. M. J.; Van Voorhis, Wesley C.; Hol, Wim G. J.; Fan, Erkang

2011-01-01

Ultrafiltration provides a generic method to discover ligands for protein drug targets with millimolar to micromolar Kd, the typical range of fragment-based drug discovery. This method was tailored to a 96-well format, and cocktails of fragment-sized molecules, with molecular masses between 150 and 300 Da, were screened against medical structural genomics target proteins. The validity of the method was confirmed through competitive binding assays in the presence of ligands known to bind the target proteins. PMID:21750879

Search efficiency of biased migration towards stationary or moving targets in heterogeneously structured environments

NASA Astrophysics Data System (ADS)

Azimzade, Youness; Mashaghi, Alireza

2017-12-01

Efficient search acts as a strong selective force in biological systems ranging from cellular populations to predator-prey systems. The search processes commonly involve finding a stationary or mobile target within a heterogeneously structured environment where obstacles limit migration. An open generic question is whether random or directionally biased motions or a combination of both provide an optimal search efficiency and how that depends on the motility and density of targets and obstacles. To address this question, we develop a simple model that involves a random walker searching for its targets in a heterogeneous medium of bond percolation square lattice and used mean first passage time (〈T 〉 ) as an indication of average search time. Our analysis reveals a dual effect of directional bias on the minimum value of 〈T 〉 . For a homogeneous medium, directionality always decreases 〈T 〉 and a pure directional migration (a ballistic motion) serves as the optimized strategy, while for a heterogeneous environment, we find that the optimized strategy involves a combination of directed and random migrations. The relative contribution of these modes is determined by the density of obstacles and motility of targets. Existence of randomness and motility of targets add to the efficiency of search. Our study reveals generic and simple rules that govern search efficiency. Our findings might find application in a number of areas including immunology, cell biology, ecology, and robotics.

Gross for kids but good for parents: differing messages in advertisements for the same products.

PubMed

Jones, Sandra; Fabrianesi, Belinda

2008-06-01

There has been surprisingly little research into the effects of food advertising on parents' perception of commonly consumed children's food items, although the available research suggests that parents may find nutritional claims in these advertisements confusing. The purpose of the present study was to investigate parents' perceptions of branded snack foods targeted at children, and the extent to which these perceptions are influenced by advertising messages. Using an intercept survey, participants were shown either adult-targeted or child-targeted advertisements for the same food products. Central business district of a major Australian city. One hundred adults, mean age 40 years. The study results suggest that: (1) adults' perceptions of advertised food products and, most importantly, purchase intentions for those products differ according to the version of the advertisement seen (for three of the products, 42-54% would buy the product after seeing the child version compared with 82-84% after seeing the adult version); and (2) adults clearly perceive distinctly different messages in advertisements for the same products which are targeting parents vs. those targeting children (e.g. for three of the products, 74-92% perceived that the adult version of the advertisement suggested the food was nutritionally beneficial compared with 2-14% perceiving this for the child version). It is clear that the messages conveyed to children about specific foods are quite different to the messages conveyed to adults - and importantly parents - about the same foods.

Bib Pharma Monopoly: Why Consumers Keep Landing on "Park Place" and How the Game is Rigged.

PubMed

Levy, Mark S

Now, more than ever before, pharmacologists are contributing medical advances to confront ravaging disease. They are developing drugs to mitigate the effects of Alzheimer’s, HIV, multiple sclerosis, and various forms of cancer. To capitalize on the opportunity, brand-name pharmaceutical firms are patenting these drugs, consequently guarding formulas and, with it, profits. Patents grant brand-name firms market exclusivity, which essentially allows them to set their own prices. Even though brand-name firms are investing some of their capital to cultivate new drugs, they also are enjoying gigantic revenue streams, absurd profit margins, and seemingly unfettered control of their respective markets. Consequently, sick patients are unable to afford their medication; high prices are bankrupting consumers in the absence of reasonably-priced generic alternatives. Despite the fact that generic drugs contain identical ingredients, cure the same symptoms, and cost 70% less, brand-name drugs persistently dominate their generic counterparts. Indeed, brand-name firms are improperly preventing generic market entry. Without generic competition, no watchdog exists to curb big pharma’s prohibitive prices. Despite the Supreme Court’s fleeting fix in FTC v. Actavis, which condemned reverse payment settlements that precluded competition, brand-name firms are employing other tactics predatorily to extend their market exclusivity and charge consumers unaffordable prices. To prevent brand-name abuse and help infirm patients afford their medication, this Comment proposes that courts apply federal antitrust law to brand-name firms that attempt to monopolize a pharmaceutical market through anticompetitive means, particularly by abusing Risk Evaluation & Mitigation Strategies (REMS) and by "product hopping." To combat exclusionary conduct, courts should mirror the “rule of reason” framework set forth in Actavis and apply an "enhanced" version specifically tailored to the pharmaceutical industry, giving stronger credence to generic challengers. In addition to finding brand-name tactics exclusionary, this Comment also proposes that courts adopt a bright-line rule prohibiting brand-name firms from exploiting the "legitimate business" defense to immunize their destructive conduct. The current framework perpetuates abuse and grants brand-name firms ostensibly indefinite monopolies. Analyzing brand-name defensive tactics under federal antitrust law would facilitate generic market entry and consequently moderate drug prices. Even after sacrificing their entire financial portfolios, patients are still unable to afford their medication. This Comment interprets Actavis as prohibiting the “legitimate business” defense and provides a remedy to deserving consumers by preventing REMS abuse and product hopping, fostering generic competition, and tempering excessive drug prices.

Measuring quality of life in dyspeptic patients: development and validation of a new specific health status questionnaire: final report from the Italian QPD project involving 4000 patients.

PubMed

Bamfi, F; Olivieri, A; Arpinelli, F; De Carli, G; Recchia, G; Gandolfi, L; Norberto, L; Pacini, F; Surrenti, C; Irvine, S H; Apolone, G

1999-03-01

Despite the fact that gastrointestinal disorders represent one of the most common reasons for medical consultations, formal assessment of patients' health-related quality of life (HRQOL) has been carried out only in a few studies, and in most cases generic questionnaires have been adopted. Because the specific issue of living with dyspeptic problems has been addressed in very few cases and no questionnaire has been shown to be appropriate for the Italian setting, a prospective project was launched to develop a specific HRQOL questionnaire for dyspepsia sufferers tailored to Italian patients but also appropriate in other cultural settings. The project consisted in a 3-yr, three-phase survey, in which different versions of the quality of life in peptic disease questionnaire (QPD) were developed through expert and patient focus groups and empiric field studies and then administered to patients recruited in five multicenter studies. Standard psychometric techniques were used to evaluate the validity, reliability, responsiveness, and patient acceptability of the QPD. Three different versions of the QPD questionnaire were self-administered to more than 4000 patients. The final 30-item version, measuring three health concepts related to dyspeptic disease (anxiety induced by pain, social restriction, symptom perception), fulfilled the recommended psychometric criteria in terms of reliability and validity, correlated with health concepts measured with a well-known independent generic HRQOL instrument (the SF-36 Health Survey questionnaire) and was relatively invariant to diagnosis and sociodemographic variables; it also correlated with a measure of gastric pain frequency and was able to detect meaningful differences over time. Although further validation studies in different cultural and linguistic settings are mandatory before any firm conclusions can be drawn regarding the cross-cultural validity of the QPD, the data obtained provide evidence of the psychometric validity and robustness of the questionnaire when used in a fairly large, well-characterized population of Italian dyspeptic patients.

HyRAM V1.0 User Guide

DOE Office of Scientific and Technical Information (OSTI.GOV)

Groth, Katrina M.; Zumwalt, Hannah Ruth; Clark, Andrew Jordan

2016-03-01

Hydrogen Risk Assessment Models (HyRAM) is a prototype software toolkit that integrates data and methods relevant to assessing the safety of hydrogen fueling and storage infrastructure. The HyRAM toolkit integrates deterministic and probabilistic models for quantifying accident scenarios, predicting physical effects, and characterizing the impact of hydrogen hazards, including thermal effects from jet fires and thermal pressure effects from deflagration. HyRAM version 1.0 incorporates generic probabilities for equipment failures for nine types of components, and probabilistic models for the impact of heat flux on humans and structures, with computationally and experimentally validated models of various aspects of gaseous hydrogen releasemore » and flame physics. This document provides an example of how to use HyRAM to conduct analysis of a fueling facility. This document will guide users through the software and how to enter and edit certain inputs that are specific to the user-defined facility. Description of the methodology and models contained in HyRAM is provided in [1]. This User’s Guide is intended to capture the main features of HyRAM version 1.0 (any HyRAM version numbered as 1.0.X.XXX). This user guide was created with HyRAM 1.0.1.798. Due to ongoing software development activities, newer versions of HyRAM may have differences from this guide.« less

Development of a self-administrated quality of life questionnaire for sarcopenia in elderly subjects: the SarQoL.

PubMed

Beaudart, Charlotte; Biver, Emmanuel; Reginster, Jean-Yves; Rizzoli, René; Rolland, Yves; Bautmans, Ivan; Petermans, Jean; Gillain, Sophie; Buckinx, Fanny; Van Beveren, Julien; Jacquemain, Marc; Italiano, Patrick; Dardenne, Nadia; Bruyere, Olivier

2015-11-01

The impact of sarcopenia on quality of life is currently assessed by generic tools. However, these tools may not detect subtle effects of this specific condition on quality of life. The aim of this study was to develop a sarcopenia-specific quality of life questionnaire (SarQoL, Sarcopenia Quality of Life) designed for community-dwelling elderly subjects aged 65 years and older. Participants were recruited in an outpatient clinic in Liège, Belgium. Sarcopenic subjects aged 65 years or older. The study was articulated in the following four stages: (i) Item generation-based on literature review, sarcopenic subjects' opinion, experts' opinion, focus groups; (ii) Item reduction-based on sarcopenic subjects' and experts' preferences; (iii) Questionnaire generation-developed during an expert meeting; (iv) Pretest of the questionnaire-based on sarcopenic subjects' opinion. The final version of the questionnaire consists of 55 items translated into 22 questions rated on a 4-point Likert scale. These items are organised into seven domains of dysfunction: Physical and mental health, Locomotion, Body composition, Functionality, Activities of daily living, Leisure activities and Fears. In view of the pretest, the SarQoL is easy to complete, independently, in ∼10 min. The first version of the SarQoL, a specific quality of life questionnaire for sarcopenic subjects, has been developed and has been shown to be comprehensible by the target population. Investigations are now required to test the psychometric properties (internal consistency, test-retest reliability, divergent and convergent validity, discriminant validity, floor and ceiling effects) of this questionnaire. © The Author 2015. Published by Oxford University Press on behalf of the British Geriatrics Society.

How to assess quality of life in child and adolescent psychiatry

PubMed Central

Ravens-Sieberer, Ulrike; Karow, Anne; Barthel, Dana; Klasen, Fionna

2014-01-01

This article provides an overview of the conceptual foundations of measuring health-related quality of life (HRQoL) in children and adolescents in child and adolescent psychiatry, and of the current state of research in this field. The available procedures for determining quality of life are presented according to their areas of use and their psychometric characteristics. The internationally available generic instruments for measuring HRQoL in children are identified and assessed in terms of their strengths and weaknesses with regard to selected criteria. As a result, seven generic HRQoL instruments and two utility procedures have been identified which satísfy the following criteria: (i) psychometric qualíty; (ii) age-appropriate measurement; (iii) versions for self-reporting and external rating; and (iv) cross-cultural measurement. The identified instruments satisfy the individual criteria to different degrees. They are increasingly being used in health services research, treatment studies, and epidemiological research; however, they are not yet widely used as part of the clinical routine in child and adolescent psychiatrics. PMID:25152654

Biosimilars in Developed and Developing East and Southeast Asian Countries: Japan, South Korea, and Malaysia-Overview, Evolution, and Regulations Assessment.

PubMed

Bas, Tomas Gabriel; Oliu Castillo, Carolina

2016-01-01

The development of biological products has experienced continuous growth over the past three decades. The expiration of patent protection for many biological medicines has led to the development of biosimilars in many countries around the world. This paper reviews the literature on biosimilar drugs and covers their therapeutic status, clinical trials, approved biosimilars, and regulatory guidelines in Japan, South Korea, and Malaysia. The literature suggests that biosimilars are comparable but not identical to the reference product. They are not a generic version of an innovative product and do not ensure therapeutic equivalence. Biosimilars present more challenges than conventional generics and their marketing approval is also much more complicated. Guidelines for biosimilars were published in Japan in July 2009 by the Ministry of Health, Labour and Welfare (MHLW), in South Korea in March 2009 by the Ministry of Food and Drug Safety (MFDS), and in Malaysia in July 2008 by the National Pharmaceutical Control Bureau (NPCB).

Holographic Tools for Probing the Dynamics of Strongly Coupled Field Theories

NASA Astrophysics Data System (ADS)

Fuini, John F.

Since it was conjectured almost 20 years ago, AdS/CFT duality, or holography, has enabled steady progress in understanding certain gauge theories in the strongly coupled limit. In this thesis we examine various aspects of holography and holographic techniques, as well as particular applications to the dynamics of strongly coupled plasmas. We discuss the energy loss of general probe defects in generic holographic plasmas and the lifetime of quasinormal modes of sufficiently short-wavelength in a strongly coupled N = 4 Super Yang-Mills (SYM) plasma. We then perform a thorough investigation of the far-from-equilibrium dynamics of the SYM plasma, focusing on how the presence of large magnetic fields or chemical potentials affect the timescale of equilibration. Finally we discuss some non-relativistic directions by finding a covariant construction of Lagrangians for spinor fields in generic Newton-Cartan backgrounds via a non-relativistic reduction, which may assist in the construction of non-relativistic versions of holography.

Biosimilars in Developed and Developing East and Southeast Asian Countries: Japan, South Korea, and Malaysia—Overview, Evolution, and Regulations Assessment

PubMed Central

Bas, Tomas Gabriel; Oliu Castillo, Carolina

2016-01-01

The development of biological products has experienced continuous growth over the past three decades. The expiration of patent protection for many biological medicines has led to the development of biosimilars in many countries around the world. This paper reviews the literature on biosimilar drugs and covers their therapeutic status, clinical trials, approved biosimilars, and regulatory guidelines in Japan, South Korea, and Malaysia. The literature suggests that biosimilars are comparable but not identical to the reference product. They are not a generic version of an innovative product and do not ensure therapeutic equivalence. Biosimilars present more challenges than conventional generics and their marketing approval is also much more complicated. Guidelines for biosimilars were published in Japan in July 2009 by the Ministry of Health, Labour and Welfare (MHLW), in South Korea in March 2009 by the Ministry of Food and Drug Safety (MFDS), and in Malaysia in July 2008 by the National Pharmaceutical Control Bureau (NPCB). PMID:27213153

Simulating the spread of malaria using a generic transmission model for mosquito-borne infectious diseases

NASA Astrophysics Data System (ADS)

Kon, Cynthia Mui Lian; Labadin, Jane

2016-06-01

Malaria is a critical infection caused by parasites which are spread to humans through mosquito bites. Approximately half of the world's population is in peril of getting infected by malaria. Mosquito-borne diseases have a standard behavior where they are transmitted in the same manner, only through vector mosquito. Taking this into account, a generic spatial-temporal model for transmission of multiple mosquito-borne diseases had been formulated. Our interest is to reproduce the actual cases of different mosquito-borne diseases using the generic model and then predict future cases so as to improve control and target measures competently. In this paper, we utilize notified weekly malaria cases in four districts in Sarawak, Malaysia, namely Kapit, Song, Belaga and Marudi. The actual cases for 36 weeks, which is from week 39 in 2012 to week 22 in 2013, are compared with simulations of the generic spatial-temporal transmission mosquito-borne diseases model. We observe that the simulation results display corresponding result to the actual malaria cases in the four districts.

Ada Compiler Validation Summary Report: Harris Corporation, Harris Ada Compiler, Version 4.0, Harris HCX-9 (Host) and (Target), 880603W1.09059

DTIC Science & Technology

1988-06-06

TYPE Of REPORT & PERIOD COVERED Ada Compiler Validation Summary Report : Harris 6 June 1988 to 6 June 1988 Corporation, Harris Ada Compiler, Version...4.0, Harris 1 PERFORINGDRG REPORT NUMBER HCX-9 (Host) and (Target), 880603W1.09059 7. AUTHOR(s) S. CONTRACT OR 6RANT NUMBER(s) Wright-Patterson AFB...88-03-02-HAR Ada COMPILER VALIDATION SUMMARY REPORT : Certificate Number: 880603WI.09059 A Harris Corporation AccessionFor Harris Ada Compiler, Version

Cost-effectiveness of lower targets for blood pressure and low-density lipoprotein cholesterol in diabetes: the Stop Atherosclerosis in Native Diabetics Study (SANDS) .

PubMed

Wilson, Charlton; Huang, Chun-Chih; Shara, Nawar; Howard, Barbara V; Fleg, Jerome L; Henderson, Jeffrey A; Howard, Wm James; Huentelman, Heather; Lee, Elisa T; Mete, Mihriye; Russell, Marie; Galloway, James M; Silverman, Angela; Stylianou, Mario; Umans, Jason; Weir, Matthew R; Yeh, Fawn; Ratner, Robert E

2010-01-01

The Stop Atherosclerosis in Native Diabetics Study (SANDS) reported cardiovascular benefit of aggressive versus standard treatment targets for both low-density lipoprotein cholesterol (LDL-C) and blood pressure (BP) in diabetic individuals. In this analysis, we examined within trial cost-effectiveness of aggressive targets of LDL-C ≤70 mg/dL and systolic BP ≤115 mmHg versus standard targets of LDL-C ≤100 mg/dL and systolic BP ≤130 mmHg. Randomized, open label blinded-to-endpoint 3-year trial. SANDS clinical trial database, Quality of Wellbeing survey, Centers for Medicare and Medicaid Services, Wholesale Drug Prices. American Indians ≥ age 40 years with type 2 diabetes and no previous cardiovascular events. April 2003 to July 2007. Health payer. Participants were randomized to aggressive versus standard groups with treatment algorithms defined for both. Incremental cost-effectiveness. Compared with the standard group, the aggressive group had slightly lower costs of medical services (-$116) but a 54% greater cost for BP medication ($1,242) and a 116% greater cost for lipid-lowering medication ($2,863), resulting in an increased cost of $3,988 over 3 years. Those in the aggressively treated group gained 0.0480 quality-adjusted life-years (QALY) over the standard group. When a 3% discount rate for costs and outcomes was used, the resulting cost per QALY was $82,589. The use of a 25%, 50%, and 75% reduction in drug costs resulted in a cost per QALY of $61,329, $40,070, and $18,810, respectively. This study was limited by use of a single ethnic group and by its 3-year duration. Within this 3-year study, treatment to lower BP and LDL-C below standard targets was not cost-effective because of the cost of the additional medications required to meet the lower targets. With the anticipated availability of generic versions of the BP and lipid-lowering drugs used in SANDS, the cost-effectiveness of this intervention should improve. Published by Elsevier Inc on behalf of the National Lipid Association.

Validity and reliability of the personnel version of the Family Empowerment Scale (FES) for the social, health and educational services in Finland.

PubMed

Vuorenmaa, Maaret; Halme, Nina; Åstedt-Kurki, Päivi; Kaunonen, Marja; Perälä, Marja-Leena

2014-04-01

This paper reports a study testing of the validity and reliability of the personnel version of the Family Empowerment Scale in family services in Finland. The role of family services in parental reinforcement is important, given their extensive reach to most families and their aim of promoting family welfare. No instruments applicable to this situation were available in Finland. The Family Empowerment Scale is a widely used instrument that measures parent's empowerment. The personnel version of the Family Empowerment Scale enables an evaluation of the reinforcement of empowerment. This study used a cross-sectional survey design. The Family Empowerment Scale was modified to measure how family services personnel evaluate reinforcement of parental empowerment. In May 2009, a questionnaire was sent to unit heads (n = 457) in public social, health and educational services for families with children aged 0-9 years. The construct, convergent and discriminant validities, reliability and responsiveness of the personnel version of the Family Empowerment Scale were assessed. According to confirmatory factor analysis, the personnel version of the Family Empowerment Scale comprised three subscales (family, service system and community) as in the original Family Empowerment Scale. Confirmed convergent and discriminant validities supported the same construct. The reliability of the personnel version of the Family Empowerment Scale was acceptable. The reinforcement level of parental empowerment was high. Parental empowerment was reinforced most in health and least in educational services. The psychometric properties of the personnel version of the Family Empowerment Scale were acceptable. It can serve as a generic instrument for assessing reinforcement of empowerment in family services in Finland. © 2013 John Wiley & Sons Ltd.

Determining the validity and reliability of the Chinese version of the Kidney Disease Quality of Life Questionnaire (KDQOL-36™)

PubMed Central

2014-01-01

Background Health-related quality of life is a crucial outcome for the chronic kidney disease population, the Kidney Disease Quality of Life (KDQOL) questionnaire is commonly used as an integral part of clinical evaluations. The abbreviated version of the KDQOL-36™ has been translated into Mandarin Chinese, but has not been tested for use in the Chinese patients. The aim of the study was to evaluate the validity and reliability of the KDQOL-36™ with a sample of Chinese patients. Methods The Mandarin Chinese version of the KDQOL-36™ has been translated by Amgen, Inc. and the MAPI Institution following the instrument translation specifications provided by the RAND health. The translated instrument was further reviewed by a Chinese expert panel for content validity and translational equivalence. The KDQOL-36™ along with Beck depression Inventory-II were administrated to 103 chronic renal disease patients recruited through convenience sampling procedure from the renal wards and an outpatient dialysis clinic. The convergent validity was determined through investigating the correlational evidence of the KDQOL-36™ with the Beck depression Inventory-II and the overall health rating. Known-group validity was supported by the evidence that the instrument could differentiate subgroups of patients. The internal consistency was estimated using Cronbach’s α and test-retest reliability was examined using an intraclass correlation coefficient. Results For the convergent validity, there were positive correlations between the overall health rating and most of the KDQOL-36™ subscales, and the Beck depression inventory score was inversely correlated with the mental component summary score and disease-specific scores of the scale. Significant correlations were noted between disease-targeted and generic dimensions of the KDQOL-36™. The results of the known-group comparisons indicated females, the unemployed, and patients had a longer dialysis history reported a worse quality of life. With regard to the reliability, the Cronbach’s alpha ranged from 0.69 to 0.78, and the intraclass correlation test-retest was higher than 0.70. Conclusions The Mandarin Chinese version of the KDQOL-36™ is a brief, valid, and reliable instrument for use in examining the quality of life of chronic kidney disease patients in China. PMID:25015224

Dynamic Assembly, Assessment, Assurance, and Adaptation via Heterogeneous Software Connectors

DTIC Science & Technology

2004-10-01

Versioning Connectors (MVC) Representative of runtime monitoring gauges are multiversioning gauges, which monitor and analyze different versions of...multiple versions of the same component must be merged by the connector before they are forwarded to their target components. The multiversioning

Clinical review: impact of statin substitution policies on patient outcomes.

PubMed

Atar, Dan; Carmena, Rafael; Clemmensen, Peter; K-Laflamme, Annik; Wassmann, Sven; Lansberg, Peter; Hobbs, Richard

2009-01-01

The increasing awareness of cost issues in health care has led to the increasing use of policy-driven substitution of branded for generic medications, particularly relative to statin treatment for cardiovascular diseases. While there are potential short-term health care savings, the consequences for primary care are under-researched. Our objective was to review data on intensive statin therapy and generic substitution in patients at high cardiovascular risk. Current treatment guidelines for the prevention of cardiovascular disease are consistent in their recommendations regarding statin therapy and treatment targets. Clinical trials demonstrate that to reduce cardiovascular events, a statin is more effective than placebo, intensive statin therapy is more effective than moderate statin therapy in patients with established coronary disease, and in patients receiving intensive statin therapy the lowest risk is associated with the lowest low-density lipoprotein levels. However, in clinical practice, patients at high cardiovascular risk are prone to be undertreated. Observational studies suggest that mandatory statin substitution may increase the gap between achieved and recommended therapeutic targets. Substitution of generic statins may be cost-saving, particularly at the primary prevention level. However, statin substitution policies have not been adequately studied on a population level. Data raise concern that mandated statin substitution may lead to unfavourable treatment choices at the level of the individual high-risk patient.

The Hawking-Penrose Singularity Theorem for C 1,1-Lorentzian Metrics

NASA Astrophysics Data System (ADS)

Graf, Melanie; Grant, James D. E.; Kunzinger, Michael; Steinbauer, Roland

2018-06-01

We show that the Hawking-Penrose singularity theorem, and the generalisation of this theorem due to Galloway and Senovilla, continue to hold for Lorentzian metrics that are of C 1,1-regularity. We formulate appropriate weak versions of the strong energy condition and genericity condition for C 1,1-metrics, and of C 0-trapped submanifolds. By regularisation, we show that, under these weak conditions, causal geodesics necessarily become non-maximising. This requires a detailed analysis of the matrix Riccati equation for the approximating metrics, which may be of independent interest.

Real-Time Reed-Solomon Decoder

NASA Technical Reports Server (NTRS)

Maki, Gary K.; Cameron, Kelly B.; Owsley, Patrick A.

1994-01-01

Generic Reed-Solomon decoder fast enough to correct errors in real time in practical applications designed to be implemented in fewer and smaller very-large-scale integrated, VLSI, circuit chips. Configured to operate in pipelined manner. One outstanding aspect of decoder design is that Euclid multiplier and divider modules contain Galoisfield multipliers configured as combinational-logic cells. Operates at speeds greater than older multipliers. Cellular configuration highly regular and requires little interconnection area, making it ideal for implementation in extraordinarily dense VLSI circuitry. Flight electronics single chip version of this technology implemented and available.

Evaluation of some significant issues affecting trajectory and control management for air-breathing hypersonic vehicles

NASA Technical Reports Server (NTRS)

Hattis, Philip D.; Malchow, Harvey L.

1992-01-01

Horizontal takeoff airbreathing-propulsion launch vehicles require near-optimal guidance and control which takes into account performance sensitivities to atmospheric characteristics while satisfying physically-derived operational constraints. A generic trajectory/control analysis tool that deepens insight into these considerations has been applied to two versions of a winged-cone vehicle model. Information that is critical to the design and trajectory of these vehicles is derived, and several unusual characteristics of the airbreathing propulsion model are shown to have potentially substantial effects on vehicle dynamics.

NQS - NETWORK QUEUING SYSTEM, VERSION 2.0 (UNIX VERSION)

NASA Technical Reports Server (NTRS)

Walter, H.

1994-01-01

The Network Queuing System, NQS, is a versatile batch and device queuing facility for a single Unix computer or a group of networked computers. With the Unix operating system as a common interface, the user can invoke the NQS collection of user-space programs to move batch and device jobs freely around the different computer hardware tied into the network. NQS provides facilities for remote queuing, request routing, remote status, queue status controls, batch request resource quota limits, and remote output return. This program was developed as part of an effort aimed at tying together diverse UNIX based machines into NASA's Numerical Aerodynamic Simulator Processing System Network. This revision of NQS allows for creating, deleting, adding and setting of complexes that aid in limiting the number of requests to be handled at one time. It also has improved device-oriented queues along with some revision of the displays. NQS was designed to meet the following goals: 1) Provide for the full support of both batch and device requests. 2) Support all of the resource quotas enforceable by the underlying UNIX kernel implementation that are relevant to any particular batch request and its corresponding batch queue. 3) Support remote queuing and routing of batch and device requests throughout the NQS network. 4) Support queue access restrictions through user and group access lists for all queues. 5) Enable networked output return of both output and error files to possibly remote machines. 6) Allow mapping of accounts across machine boundaries. 7) Provide friendly configuration and modification mechanisms for each installation. 8) Support status operations across the network, without requiring a user to log in on remote target machines. 9) Provide for file staging or copying of files for movement to the actual execution machine. To support batch and device requests, NQS v.2 implements three queue types--batch, device and pipe. Batch queues hold and prioritize batch requests; device queues hold and prioritize device requests; pipe queues transport both batch and device requests to other batch, device, or pipe queues at local or remote machines. Unique to batch queues are resource quota limits that restrict the amounts of different resources that a batch request can consume during execution. Unique to each device queue is a set of one or more devices, such as a line printer, to which requests can be sent for execution. Pipe queues have associated destinations to which they route and deliver requests. If the proper destination machine is down or unreachable, pipe queues are able to requeue the request and deliver it later when the destination is available. All NQS network conversations are performed using the Berkeley socket mechanism as ported into the respective vendor kernels. NQS is written in C language. The generic UNIX version (ARC-13179) has been successfully implemented on a variety of UNIX platforms, including Sun3 and Sun4 series computers, SGI IRIS computers running IRIX 3.3, DEC computers running ULTRIX 4.1, AMDAHL computers running UTS 1.3 and 2.1, platforms running BSD 4.3 UNIX. The IBM RS/6000 AIX version (COS-10042) is a vendor port. NQS 2.0 will also communicate with the Cray Research, Inc. and Convex, Inc. versions of NQS. The standard distribution medium for either machine version of NQS 2.0 is a 60Mb, QIC-24, .25 inch streaming magnetic tape cartridge in UNIX tar format. Upon request the generic UNIX version (ARC-13179) can be provided in UNIX tar format on alternate media. Please contact COSMIC to discuss the availability and cost of media to meet your specific needs. An electronic copy of the NQS 2.0 documentation is included on the program media. NQS 2.0 was released in 1991. The IBM RS/6000 port of NQS was developed in 1992. IRIX is a trademark of Silicon Graphics Inc. IRIS is a registered trademark of Silicon Graphics Inc. UNIX is a registered trademark of UNIX System Laboratories Inc. Sun3 and Sun4 are trademarks of Sun Microsystems Inc. DEC and ULTRIX are trademarks of Digital Equipment Corporation.

[The Spanish version of the Short Form 36 Health Survey: a decade of experience and new developments].

PubMed

Vilagut, Gemma; Ferrer, Montse; Rajmil, Luis; Rebollo, Pablo; Permanyer-Miralda, Gaietà; Quintana, José M; Santed, Rosalía; Valderas, José M; Ribera, Aida; Domingo-Salvany, Antonia; Alonso, Jordi

2005-01-01

The Short Form-36 Health Survey (SF-36) is one of the most widely used and evaluated generic health-related quality of life (HRQL) questionnaires. After almost a decade of use in Spain, the present article critically reviews the content and metric properties of the Spanish version, as well as its new developments. A review of indexed articles that used the Spanish version of the SF-36 was performed in Medline (PubMed), the Spanish bibliographic databases IBECS and IME. Articles that provided information on the measurement model, reliability, validity, and responsiveness to change of the instrument were selected. Seventy-nine articles were found, of which 17 evaluated the metric characteristics of the questionnaire. The reliability of the SF-36 scales was higher than the suggested standard (Cronbach's alpha) of 0.7 in 96% of the evaluations. Grouped evaluations obtained by meta-analysis were higher than 0.7 in all cases. The SF-36 showed good discrimination among severity groups, moderate correlations with clinical indicators, and high correlations with other HRQL instruments. Moreover, questionnaire scores predicted mortality and were able to detect improvement due to therapeutic interventions such as coronary angioplasty, benign prostatic hyperplasia surgery, and non-invasive positive pressure home ventilation. The new developments (norm-based scoring, version 2, the SF-12 and SF-8) improved both the metric properties and interpretation of the questionnaire. The Spanish version of the SF-36 and its recently developed versions is a suitable instrument for use in medical research, as well as in clinical practice.

Change-Based Satellite Monitoring Using Broad Coverage and Targetable Sensing

NASA Technical Reports Server (NTRS)

Chien, Steve A.; Tran, Daniel Q.; Doubleday, Joshua R.; Doggett, Thomas

2013-01-01

A generic software framework analyzes data from broad coverage sweeps or general larger areas of interest. Change detection methods are used to extract subsets of directed swath areas that intersect areas of change. These areas are prioritized and allocated to targetable assets. This method is deployed in an automatic fashion, and has operated without human monitoring or intervention for sustained periods of time (months).

Does the small fit them all? The utility of Disabkids-10 Index for the assessment of pediatric health-related quality of life across age-groups, genders, and informants.

PubMed

Carona, Carlos; Silva, Neuza; Moreira, Helena; Canavarro, Maria Cristina; Bullinger, Monika

2015-12-01

The objective of this study was twofold: First, to conduct a confirmatory factor analysis of the Portuguese versions of Disabkids-10; and second, to examine potential differences in factor structures between age-groups, genders, and informants. The sample included 293 school-aged children and adolescents with chronic health conditions and 197 parents. Both family members (whenever possible) completed the self- and proxy-report versions of Disabkids-10. The factorial model of Disabkids-10 had good fit for self-reported data and minimally acceptable fit for proxy-reported data. The multigroup analyses confirmed the model invariance across age-groups (children vs. adolescents), genders (boys vs. girls), and informants (children vs. parents). The generic developmental applicability of these questionnaires makes them recommended for health care routine assessments on pediatric intervention needs and outcomes. © The Author(s) 2014.

Tool for Rapid Analysis of Monte Carlo Simulations

NASA Technical Reports Server (NTRS)

Restrepo, Carolina; McCall, Kurt E.; Hurtado, John E.

2011-01-01

Designing a spacecraft, or any other complex engineering system, requires extensive simulation and analysis work. Oftentimes, the large amounts of simulation data generated are very di cult and time consuming to analyze, with the added risk of overlooking potentially critical problems in the design. The authors have developed a generic data analysis tool that can quickly sort through large data sets and point an analyst to the areas in the data set that cause specific types of failures. The Tool for Rapid Analysis of Monte Carlo simulations (TRAM) has been used in recent design and analysis work for the Orion vehicle, greatly decreasing the time it takes to evaluate performance requirements. A previous version of this tool was developed to automatically identify driving design variables in Monte Carlo data sets. This paper describes a new, parallel version, of TRAM implemented on a graphical processing unit, and presents analysis results for NASA's Orion Monte Carlo data to demonstrate its capabilities.

Generic approach for synthesizing asymmetric nanoparticles and nanoassemblies

DOEpatents

Sun, Yugang; Hu, Yongxing

2015-05-26

A generic route for synthesis of asymmetric nanostructures. This approach utilizes submicron magnetic particles (Fe.sub.3O.sub.4--SiO.sub.2) as recyclable solid substrates for the assembly of asymmetric nanostructures and purification of the final product. Importantly, an additional SiO.sub.2 layer is employed as a mediation layer to allow for selective modification of target nanoparticles. The partially patched nanoparticles are used as building blocks for different kinds of complex asymmetric nanostructures that cannot be fabricated by conventional approaches. The potential applications such as ultra-sensitive substrates for surface enhanced Raman scattering (SERS) have been included.

[Intention of purchasing generic prescription drugs on the part of consumers in Asturias, Spain].

PubMed

González Hernando, Santiago; González Mieres, Celina; Díaz Martín, Ana M

2003-01-01

Ascertaining how consumers perceive the risk related to the use of generic prescription drugs and those factors which have the greatest impact on the intention to request a generic drug from the prescribing physician and/or the pharmacist for the purpose of determining any possible barriers or hindrances to the acceptance of generics and to gather information to aid healthcare managers in their decision-making processes. Study on prescription drug use revolving around the degree to which patients are willing to request an EFG. In this quantitative transversal study, a total of 542 individuals were individually surveyed upon exiting a healthcare center or pharmacy in Asturias. A scale for measuring the perceived risk involved in the purchase of a prescription drug including 15 attributes grouped into five aspects was included in the questionnaire. Information was also gathered regarding the intention of using generic prescription drugs and on the demographic and socioeconomic characteristics of those surveyed. For the analysis of the results, a factorial confirmational analysis, multiple regression and univariate analysis were used. The data was processed using the EQS and SPSS statistics programs. Mean perception of the risk (scales 1-7): functional: 2.75; physical: 2.68: financial: 2.19; psychological: 1.99; social: 1.42. Factors having a bearing on the intention of requesting generic prescription drugs from their physician: psychological risk (p = 0.000). On requesting the same from their pharmacist: psychological risk (p = 0.000) and social risk (p = 0.020). The agents interested in the development on the EFG market should target their communication efforts on putting the functional and financial aspects of the manufacturer's specialties and generic specialties on the same level, but should not leave out psychological and social aspects of the consumers' purchasing behavior.

A Targeting Microbubble for Ultrasound Molecular Imaging

PubMed Central

Yeh, James Shue-Min; Sennoga, Charles A.; McConnell, Ellen; Eckersley, Robert; Tang, Meng-Xing; Nourshargh, Sussan; Seddon, John M.; Haskard, Dorian O.; Nihoyannopoulos, Petros

2015-01-01

Rationale Microbubbles conjugated with targeting ligands are used as contrast agents for ultrasound molecular imaging. However, they often contain immunogenic (strept)avidin, which impedes application in humans. Although targeting bubbles not employing the biotin-(strept)avidin conjugation chemistry have been explored, only a few reached the stage of ultrasound imaging in vivo, none were reported/evaluated to show all three of the following properties desired for clinical applications: (i) low degree of non-specific bubble retention in more than one non-reticuloendothelial tissue; (ii) effective for real-time imaging; and (iii) effective for acoustic quantification of molecular targets to a high degree of quantification. Furthermore, disclosures of the compositions and methodologies enabling reproduction of the bubbles are often withheld. Objective To develop and evaluate a targeting microbubble based on maleimide-thiol conjugation chemistry for ultrasound molecular imaging. Methods and Results Microbubbles with a previously unreported generic (non-targeting components) composition were grafted with anti-E-selectin F(ab’)2 using maleimide-thiol conjugation, to produce E-selectin targeting microbubbles. The resulting targeting bubbles showed high specificity to E-selectin in vitro and in vivo. Non-specific bubble retention was minimal in at least three non-reticuloendothelial tissues with inflammation (mouse heart, kidneys, cremaster). The bubbles were effective for real-time ultrasound imaging of E-selectin expression in the inflamed mouse heart and kidneys, using a clinical ultrasound scanner. The acoustic signal intensity of the targeted bubbles retained in the heart correlated strongly with the level of E-selectin expression (|r|≥0.8), demonstrating a high degree of non-invasive molecular quantification. Conclusions Targeting microbubbles for ultrasound molecular imaging, based on maleimide-thiol conjugation chemistry and the generic composition described, may possess properties (i)–(iii) desired for clinical applications. PMID:26161541

Toxicological risk assessment and prioritization of drinking water relevant contaminants of emerging concern.

PubMed

Baken, Kirsten A; Sjerps, Rosa M A; Schriks, Merijn; van Wezel, Annemarie P

2018-06-13

Toxicological risk assessment of contaminants of emerging concern (CEC) in (sources of) drinking water is required to identify potential health risks and prioritize chemicals for abatement or monitoring. In such assessments, concentrations of chemicals in drinking water or sources are compared to either (i) health-based (statutory) drinking water guideline values, (ii) provisional guideline values based on recent toxicity data in absence of drinking water guidelines, or (iii) generic drinking water target values in absence of toxicity data. Here, we performed a toxicological risk assessment for 163 CEC that were selected as relevant for drinking water. This relevance was based on their presence in drinking water and/or groundwater and surface water sources in downstream parts of the Rhine and Meuse, in combination with concentration levels and physicochemical properties. Statutory and provisional drinking water guideline values could be derived from publically available toxicological information for 142 of the CEC. Based on measured concentrations it was concluded that the majority of substances do not occur in concentrations which individually pose an appreciable human health risk. A health concern could however not be excluded for vinylchloride, trichloroethene, bromodichloromethane, aniline, phenol, 2-chlorobenzenamine, mevinphos, 1,4-dioxane, and nitrolotriacetic acid. For part of the selected substances, toxicological risk assessment for drinking water could not be performed since either toxicity data (hazard) or drinking water concentrations (exposure) were lacking. In absence of toxicity data, the Threshold of Toxicological Concern (TTC) approach can be applied for screening level risk assessment. The toxicological information on the selected substances was used to evaluate whether drinking water target values based on existing TTC levels are sufficiently protective for drinking water relevant CEC. Generic drinking water target levels of 37 μg/L for Cramer class I substances and 4 μg/L for Cramer class III substances in drinking water were derived based on these CEC. These levels are in line with previously reported generic drinking water target levels based on original TTC values and are shown to be protective for health effects of the majority of contaminants of emerging concern evaluated in the present study. Since the human health impact of many chemicals appearing in the water cycle has been studied insufficiently, generic drinking water target levels are useful for early warning and prioritization of CEC with unknown toxicity in drinking water and its sources for future monitoring. Copyright © 2018 Elsevier Ltd. All rights reserved.

A generic, cost-effective, and scalable cell lineage analysis platform

PubMed Central

Biezuner, Tamir; Spiro, Adam; Raz, Ofir; Amir, Shiran; Milo, Lilach; Adar, Rivka; Chapal-Ilani, Noa; Berman, Veronika; Fried, Yael; Ainbinder, Elena; Cohen, Galit; Barr, Haim M.; Halaban, Ruth; Shapiro, Ehud

2016-01-01

Advances in single-cell genomics enable commensurate improvements in methods for uncovering lineage relations among individual cells. Current sequencing-based methods for cell lineage analysis depend on low-resolution bulk analysis or rely on extensive single-cell sequencing, which is not scalable and could be biased by functional dependencies. Here we show an integrated biochemical-computational platform for generic single-cell lineage analysis that is retrospective, cost-effective, and scalable. It consists of a biochemical-computational pipeline that inputs individual cells, produces targeted single-cell sequencing data, and uses it to generate a lineage tree of the input cells. We validated the platform by applying it to cells sampled from an ex vivo grown tree and analyzed its feasibility landscape by computer simulations. We conclude that the platform may serve as a generic tool for lineage analysis and thus pave the way toward large-scale human cell lineage discovery. PMID:27558250

Surrogate oracles, generalized dependency and simpler models

NASA Technical Reports Server (NTRS)

Wilson, Larry

1990-01-01

Software reliability models require the sequence of interfailure times from the debugging process as input. It was previously illustrated that using data from replicated debugging could greatly improve reliability predictions. However, inexpensive replication of the debugging process requires the existence of a cheap, fast error detector. Laboratory experiments can be designed around a gold version which is used as an oracle or around an n-version error detector. Unfortunately, software developers can not be expected to have an oracle or to bear the expense of n-versions. A generic technique is being investigated for approximating replicated data by using the partially debugged software as a difference detector. It is believed that the failure rate of each fault has significant dependence on the presence or absence of other faults. Thus, in order to discuss a failure rate for a known fault, the presence or absence of each of the other known faults needs to be specified. Also, in simpler models which use shorter input sequences without sacrificing accuracy are of interest. In fact, a possible gain in performance is conjectured. To investigate these propositions, NASA computers running LIC (RTI) versions are used to generate data. This data will be used to label the debugging graph associated with each version. These labeled graphs will be used to test the utility of a surrogate oracle, to analyze the dependent nature of fault failure rates and to explore the feasibility of reliability models which use the data of only the most recent failures.

Translation, adaptation and validation of two versions of the Chronic Liver Disease Questionnaire in Malaysian patients for speakers of both English and Malay languages: a cross-sectional study

PubMed Central

Khairullah, Shasha; Mahadeva, Sanjiv

2017-01-01

Objective We aimed to adapt, translate and validate the Chronic Liver Disease Questionnaire (CLDQ) in Malaysian patients with chronic liver diseases of various aetiologies. Setting Tertiary level teaching institution in Malaysia. Participants The validation process involved 211 adult patients (English language n=101, Malay language n=110) with chronic liver disease. Characteristics of the study subjects were as follows: mean (SD) age was 56 (12.8) years, 58.3% were male and 41.7% female. The inclusion criteria were patients 18 years or older with chronic hepatitis and/or liver cirrhosis of any aetiology. The exclusion criteria were as follows: presence of hepatic encephalopathy, ongoing treatment with interferon and presence of other chronic conditions that have an impact on health-related quality of life (HRQOL). Methods A cross-sectional study was conducted. Cultural adaptation of the English version of the CLDQ was performed, and a Malay version was developed following standard forward–backward translation by independent native speakers. Psychometric properties of both versions were determined by assessing their internal consistency, test–retest reliability and discriminant and convergent validity. Results Cronbach’s alpha for internal consistency across the various domains of the CLDQ was 0.95 for the English version and 0.92 for the Malay version. Test–retest analysis showed excellent reliability with an intraclass correlation coefficient of 0.89 for the English version and 0.93 for the Malay version. The average scores of both the English and Malay versions of the CLDQ demonstrated adequate discriminant validity by differentiating between non-cirrhosis (English 6.3, Malay 6.1), compensated cirrhosis (English 5.6, Malay 6.0) and decompensated cirrhosis (English 5.1, Malay 4.9) (p<0.001). Convergent validity showed that correlation was fair between the English (ρ=0.59) and Malay (p=0.47) CLDQ versions with the EQ-5D, a generic HRQOL instrument. Conclusion The English and Malay versions of the CLDQ are reliable and valid disease-specific instruments for assessing HRQOL in Malaysian patients with chronic liver disease. PMID:28550020

Floquet–Magnus theory and generic transient dynamics in periodically driven many-body quantum systems

DOE Office of Scientific and Technical Information (OSTI.GOV)

Kuwahara, Tomotaka, E-mail: tomotaka.phys@gmail.com; WPI, Advanced Institute for Materials Research, Tohoku University, Sendai 980-8577; Mori, Takashi

2016-04-15

This work explores a fundamental dynamical structure for a wide range of many-body quantum systems under periodic driving. Generically, in the thermodynamic limit, such systems are known to heat up to infinite temperature states in the long-time limit irrespective of dynamical details, which kills all the specific properties of the system. In the present study, instead of considering infinitely long-time scale, we aim to provide a general framework to understand the long but finite time behavior, namely the transient dynamics. In our analysis, we focus on the Floquet–Magnus (FM) expansion that gives a formal expression of the effective Hamiltonian onmore » the system. Although in general the full series expansion is not convergent in the thermodynamics limit, we give a clear relationship between the FM expansion and the transient dynamics. More precisely, we rigorously show that a truncated version of the FM expansion accurately describes the exact dynamics for a certain time-scale. Our theory reveals an experimental time-scale for which non-trivial dynamical phenomena can be reliably observed. We discuss several dynamical phenomena, such as the effect of small integrability breaking, efficient numerical simulation of periodically driven systems, dynamical localization and thermalization. Especially on thermalization, we discuss a generic scenario on the prethermalization phenomenon in periodically driven systems. -- Highlights: •A general framework to describe transient dynamics for periodically driven systems. •The theory is applicable to generic quantum many-body systems including long-range interacting systems. •Physical meaning of the truncation of the Floquet–Magnus expansion is rigorously established. •New mechanism of the prethermalization is proposed. •Revealing an experimental time-scale for which non-trivial dynamical phenomena can be reliably observed.« less

Interchangeability, Safety and Efficacy of Modified-Release Drug Formulations in the USA: The Case of Opioid and Other Nervous System Drugs.

PubMed

Seoane-Vazquez, Enrique; Rodriguez-Monguio, Rosa; Hansen, Richard

2016-04-01

Modified-release drugs may provide clinical advantages compared to immediate-release forms and improve convenience to the patient and health outcomes. Concerns have been raised regarding interchangeability, efficacy, and safety of modified-release formulations. This study analyses all US Food and Drug Administration (FDA)-approved modified-release formulations and market trends, and illustrates how bioequivalence and safety of generic modified-release products compare to their respective brand name drugs and other generic drugs with different formulation design characteristics. This study also examines major concerns related to modified-release formulations: safety of opioids and bioequivalence of generic bupropion and methylphenidate. Study data were derived from the FDA electronic versions of the FDA's Orange Book (OB) and the FDA safety communications web page. Medicare Part D utilization and expenditures data were extracted from the Centers for Medicare and Medicaid. In May 2015, 276 (11.9 %) of the 2325 active ingredients and fixed-dose combinations listed in the FDA's Orange Book had at least one modified-release form approved by the FDA. The number of approvals increased over time; 52.5 % of modified releases were approved in the period 2000-May 2015. The FDA required a risk evaluation and mitigation strategy (REMS) to ensure that the benefits of extended-release opioids outweighed its risks of overdose and abuse. The REMS involved 16 new drug applications and 25 abbreviated new drug applications. The FDA addressed interchangeability problems with generic modified-release alternatives of bupropion and methylphenidate including lack of bioequivalence, reduced efficacy, and increased incidence of adverse events. Systematic post-marketing surveillance studies are needed to assess differences in safety, interchangeability, and efficacy of drugs with modified- and immediate-release formulations.

Development and Validation of a Novel Generic Health-related Quality of Life Instrument With 20 Items (HINT-20).

PubMed

Jo, Min-Woo; Lee, Hyeon-Jeong; Kim, Soo Young; Kim, Seon-Ha; Chang, Hyejung; Ahn, Jeonghoon; Ock, Minsu

2017-01-01

Few attempts have been made to develop a generic health-related quality of life (HRQoL) instrument and to examine its validity and reliability in Korea. We aimed to do this in our present study. After a literature review of existing generic HRQoL instruments, a focus group discussion, in-depth interviews, and expert consultations, we selected 30 tentative items for a new HRQoL measure. These items were evaluated by assessing their ceiling effects, difficulty, and redundancy in the first survey. To validate the HRQoL instrument that was developed, known-groups validity and convergent/discriminant validity were evaluated and its test-retest reliability was examined in the second survey. Of the 30 items originally assessed for the HRQoL instrument, four were excluded due to high ceiling effects and six were removed due to redundancy. We ultimately developed a HRQoL instrument with a reduced number of 20 items, known as the Health-related Quality of Life Instrument with 20 items (HINT-20), incorporating physical, mental, social, and positive health dimensions. The results of the HINT-20 for known-groups validity were poorer in women, the elderly, and those with a low income. For convergent/discriminant validity, the correlation coefficients of items (except vitality) in the physical health dimension with the physical component summary of the Short Form 36 version 2 (SF-36v2) were generally higher than the correlations of those items with the mental component summary of the SF-36v2, and vice versa. Regarding test-retest reliability, the intraclass correlation coefficient of the total HINT-20 score was 0.813 (p<0.001). A novel generic HRQoL instrument, the HINT-20, was developed for the Korean general population and showed acceptable validity and reliability.

Psychometric properties of the Swedish PedsQL, Pediatric Quality of Life Inventory 4.0 generic core scales.

PubMed

Petersen, Solveig; Hägglöf, Bruno; Stenlund, Hans; Bergström, Erik

2009-09-01

To study the psychometric performance of the Swedish version of the Pediatric Quality of Life Inventory (PedsQL) 4.0 generic core scales in a general child population in Sweden. PedsQL forms were distributed to 2403 schoolchildren and 888 parents in two different school settings. Reliability and validity was studied for self-reports and proxy reports, full forms and short forms. Confirmatory factor analysis tested the factor structure and multigroup confirmatory factor analysis tested measurement invariance between boys and girls. Test-retest reliability was demonstrated for all scales and internal consistency reliability was shown with alpha value exceeding 0.70 for all scales but one (self-report short form: social functioning). Child-parent agreement was low to moderate. The four-factor structure of the PedsQL and factorial invariance across sex subgroups were confirmed for the self-report forms and for the proxy short form, while model fit indices suggested improvement of several proxy full-form scales. The Swedish PedsQL 4.0 generic core scales are a reliable and valid tool for health-related quality of life (HRQoL) assessment in Swedish child populations. The proxy full form, however, should be used with caution. The study also support continued use of the PedsQL as a four-factor model, capable of revealing meaningful HRQoL differences between boys and girls.

Ada Compiler Validation Summary Report: Certificate Number 890627W1. 10103 Harris Corporation, Computer Systems Division, Harris Ada, Version 5.0 Harris H1000

DTIC Science & Technology

1989-06-27

Department of Defense Washington DC 20301-3081 Ada Compiler Validation Summary Report : Compiler Name: Harris Ada, Version 5.0 Certificate Number...890627W1.10103 Host: Harris HIOO0 under VOS, E.i Target: Harris HiO00 under VOS, E.1 Testing Completed June 27, 1989 using ACVC 1.10 This report has been...arris Corporation, Computer Systems Division Harris Ada, Version 5.0, Harris H1000 under VOS, 8.1 (Host & Target), Wright-Patterson AFB, ACVC 1.10 DD

Ada Compiler Validation Summary Report: Certificate Number: 880318W1. 09041, International Business Machines Corporation, IBM Development System for the Ada Language, Version 2.1.0, IBM 4381 under VM/HPO, Host and Target

DTIC Science & Technology

1988-03-28

International Business Machines Corporation IBM Development System for the Ada Language, Version 2.1.0 IBM 4381 under VM/HPO, host and target DTIC...necessary and identify by block number) International Business Machines Corporation, IBM Development System for the Ada Language, Version 2.1.0, IBM...in the compiler listed in this declaration. I declare that International Business Machines Corporation is the owner of record of the object code of the

The Development and Validation of a Generic Instrument, QoDoS, for Assessing the Quality of Decision Making.

PubMed

Donelan, Ronan; Walker, Stuart; Salek, Sam

2016-01-01

The impact of decision-making during the development and the regulatory review of medicines greatly influences the delivery of new medicinal products. Currently, there is no generic instrument that can be used to assess the quality of decision-making. This study describes the development of the Quality of Decision-Making Orientation Scheme QoDoS(©) instrument for appraising the quality of decision-making. Semi-structured interviews about decision-making were carried out with 29 senior decision makers from the pharmaceutical industry (10), regulatory authorities (9) and contract research organizations (10). The interviews offered a qualified understanding of the subjective decision-making approach, influences, behaviors and other factors that impact such processes for individuals and organizations involved in the delivery of new medicines. Thematic analysis of the transcribed interviews was carried out using NVivo8® software. Content validity was carried out using qualitative and quantitative data by an expert panel, which led to the developmental version of the QoDoS. Further psychometric evaluations were performed, including factor analysis, item reduction, reliability testing and construct validation. The thematic analysis of the interviews yielded a 94-item initial version of the QoDoS(©) with a 5-point Likert scale. The instrument was tested for content validity using a panel of experts for language clarity, completeness, relevance and scaling, resulting in a favorable agreement by panel members with an intra-class correlation coefficient value of 0.89 (95% confidence interval = 0.56, 0.99). A 76-item QoDoS(©) (version 2) emerged from content validation. Factor analysis produced a 47-item measure with four domains. The 47-item QoDoS(©) (version 3) showed high internal consistency (n = 120, Cronbach's alpha = 0.89), high reproducibility (n = 20, intra-class correlation = 0.77) and a mean completion time of 10 min. Reliability testing and construct validation was successfully performed. The QoDoS(©) is both reliable and valid for use. It has the potential for extensive use in medicines development by both the pharmaceutical industry and regulatory authorities. The QoDoS(©) can be used to assess the quality of decision-making and to inform decision makers of the factors that influence decision-making.

Adaptation of the Tool to Estimate Patient Costs Questionnaire into Indonesian Context for Tuberculosis-affected Households.

PubMed

Fuady, Ahmad; Houweling, Tanja A; Mansyur, Muchtaruddin; Richardus, Jan H

2018-01-01

Indonesia is the second-highest country for tuberculosis (TB) incidence worldwide. Hence, it urgently requires improvements and innovations beyond the strategies that are currently being implemented throughout the country. One fundamental step in monitoring its progress is by preparing a validated tool to measure total patient costs and catastrophic total costs. The World Health Organization (WHO) recommends using a version of the generic questionnaire that has been adapted to the local cultural context in order to interpret findings correctly. This study is aimed to adapt the Tool to Estimate Patient Costs questionnaire into the Indonesian context, which measures total costs and catastrophic total costs for tuberculosis-affected households. the tool was adapted using best-practice guidelines. On the basis of a pre-test performed in a previous study (referred to as Phase 1 Study), we refined the adaptation process by comparing it with the generic tool introduced by the WHO. We also held an expert committee review and performed pre-testing by interviewing 30 TB patients. After pre-testing, the tool was provided with complete explanation sheets for finalization. seventy-two major changes were made during the adaptation process including changing the answer choices to match the Indonesian context, refining the flow of questions, deleting questions, changing some words and restoring original questions that had been changed in Phase 1 Study. Participants indicated that most questions were clear and easy to understand. To address recall difficulties by the participants, we made some adaptations to obtain data that might be missing, such as tracking data to medical records, developing a proxy of costs and guiding interviewers to ask for a specific value when participants were uncertain about the estimated market value of property they had sold. the adapted Tool to Estimate Patient Costs in Bahasa Indonesia is comprehensive and ready for use in future studies on TB-related catastrophic costs and is suitable for monitoring progress to achieve the target of the End TB Strategy.

Why do generic drugs fail to achieve an adequate market share in Greece? Empirical findings and policy suggestions.

PubMed

Balasopoulos, T; Charonis, A; Athanasakis, K; Kyriopoulos, J; Pavi, E

2017-03-01

Since 2010, the memoranda of understanding were implemented in Greece as a measure of fiscal adjustment. Public pharmaceutical expenditure was one of the main focuses of this implementation. Numerous policies, targeted on pharma spending, reduced the pharmaceutical budget by 60.5%. Yet, generics' penetration in Greece remained among the lowest among OECD countries. This study aims to highlight the factors that affect the perceptions of the population on generic drugs and to suggest effective policy measures. The empirical analysis is based on a national cross-sectional survey that was conducted through a sample of 2003 individuals, representative of the general population. Two ordinal logistic regression models were constructed in order to identify the determinants that affect the respondents' beliefs on the safety and the effectiveness of generic drugs. The empirical findings presented a positive and statistically significant correlation with income, bill payment difficulties, safety and effectiveness of drugs, prescription and dispensing preferences and the views toward pharmaceutical companies. Also, age and trust toward medical community have a positive and statistically significant correlation with the perception on the safety of generic drugs. Policy interventions are suggested on the bases of the empirical results on 3 major categories; (a) information campaigns, (b) incentives to doctors and pharmacists and (c) to strengthen the bioequivalence control framework and the dissemination of results. Copyright © 2017 Elsevier B.V. All rights reserved.

Effects of explicit and implicit prompts on students' inquiry practices in computer-supported learning environments in high school earth science

NASA Astrophysics Data System (ADS)

Fang, Su-Chi; Hsu, Ying-Shao; Hsu, Wei Hsiu

2016-07-01

The study explored how to best use scaffolds for supporting students' inquiry practices in computer-supported learning environments. We designed a series of inquiry units assisted with three versions of written inquiry prompts (generic and context-specific); that is, three scaffold-fading conditions: implicit, explicit, and fading. We then examined how the three scaffold-fading conditions influenced students' conceptual understanding, understanding of scientific inquiry, and inquiry abilities. Three grade-10 classes (N = 105) participated in this study; they were randomly assigned to and taught in the three conditions. Data-collection procedures included a pretest-posttest approach and in-depth observations of the target students. The findings showed that after these inquiry units, all of the students exhibited significant learning gains in conceptual knowledge and performed better inquiry abilities regardless of which condition was used. The explicit and fading conditions were more effective in enhancing students' understanding of scientific inquiry. The fading condition tended to better support the students' development of inquiry abilities and help transfer these abilities to a new setting involving an independent socioscientific task about where to build a dam. The results suggest that fading plays an essential role in enhancing the effectiveness of scaffolds.

Rituximab biosimilars.

PubMed

Vital, Edward M; Kay, Jonathan; Emery, Paul

2013-07-01

Rituximab is a monoclonal antibody targeting CD20, used to treat B cell malignancies and B cell-mediated autoimmune diseases. Rituximab has the largest market of any monoclonal antibody therapeutic. Its patent will expire within the next few years and several manufacturers have already produced or are developing rituximab biosimilars that aim to match the innovator rituximab as closely as possible. In this review, we discuss key factors that determine the efficacy of rituximab therapy, potential technical challenges in the manufacture and evaluation of biosimilars, regulatory considerations regarding the review and approval of biosimilars, and the current status of biosimilar rituximab development by various manufacturers. Due to the nature of the topic, literature searches included conference abstracts, regulatory and industry websites as well as peer reviewed literature. Cost is a key limitation of current biologics usage and there is a political impetus to the licensing of biosimilars. Concerns regarding potential dissimilarities of biosimilars are legitimate, but surmountable with techniques for in vitro, in vivo and clinical testing and more clearly defined regulatory requirements. These should provide reassurance to prescribers. However, the cost of manufacturing and licensing a biosimilar remains high and the reduction in cost may be more limited than for a non-biologic small molecule drug and its generic version. This cost reduction will be critical to the impact and use of rituximab biosimilars.

PEGASUS 5: An Automated Pre-Processor for Overset-Grid CFD

NASA Technical Reports Server (NTRS)

Suhs, Norman E.; Rogers, Stuart E.; Dietz, William E.; Kwak, Dochan (Technical Monitor)

2002-01-01

An all new, automated version of the PEGASUS software has been developed and tested. PEGASUS provides the hole-cutting and connectivity information between overlapping grids, and is used as the final part of the grid generation process for overset-grid computational fluid dynamics approaches. The new PEGASUS code (Version 5) has many new features: automated hole cutting; a projection scheme for fixing gaps in overset surfaces; more efficient interpolation search methods using an alternating digital tree; hole-size optimization based on adding additional layers of fringe points; and an automatic restart capability. The new code has also been parallelized using the Message Passing Interface standard. The parallelization performance provides efficient speed-up of the execution time by an order of magnitude, and up to a factor of 30 for very large problems. The results of three example cases are presented: a three-element high-lift airfoil, a generic business jet configuration, and a complete Boeing 777-200 aircraft in a high-lift landing configuration. Comparisons of the computed flow fields for the airfoil and 777 test cases between the old and new versions of the PEGASUS codes show excellent agreement with each other and with experimental results.

Building energy simulation in real time through an open standard interface

DOE PAGES

Pang, Xiufeng; Nouidui, Thierry S.; Wetter, Michael; ...

2015-10-20

Building energy models (BEMs) are typically used for design and code compliance for new buildings and in the renovation of existing buildings to predict energy use. We present the increasing adoption of BEM as standard practice in the building industry presents an opportunity to extend the use of BEMs into construction, commissioning and operation. In 2009, the authors developed a real-time simulation framework to execute an EnergyPlus model in real time to improve building operation. This paper reports an enhancement of that real-time energy simulation framework. The previous version only works with software tools that implement the custom co-simulation interfacemore » of the Building Controls Virtual Test Bed (BCVTB), such as EnergyPlus, Dymola and TRNSYS. The new version uses an open standard interface, the Functional Mockup Interface (FMI), to provide a generic interface to any application that supports the FMI protocol. In addition, the new version utilizes the Simple Measurement and Actuation Profile (sMAP) tool as the data acquisition system to acquire, store and present data. Lastly, this paper introduces the updated architecture of the real-time simulation framework using FMI and presents proof-of-concept demonstration results which validate the new framework.« less

A generic nuclei detection method for histopathological breast images

NASA Astrophysics Data System (ADS)

Kost, Henning; Homeyer, André; Bult, Peter; Balkenhol, Maschenka C. A.; van der Laak, Jeroen A. W. M.; Hahn, Horst K.

2016-03-01

The detection of cell nuclei plays a key role in various histopathological image analysis problems. Considering the high variability of its applications, we propose a novel generic and trainable detection approach. Adaption to specific nuclei detection tasks is done by providing training samples. A trainable deconvolution and classification algorithm is used to generate a probability map indicating the presence of a nucleus. The map is processed by an extended watershed segmentation step to identify the nuclei positions. We have tested our method on data sets with different stains and target nuclear types. We obtained F1-measures between 0.83 and 0.93.

Confirmatory factor analysis of 2 versions of the Brief Pain Inventory in an ambulatory population indicates that sleep interference should be interpreted separately.

PubMed

Walton, David M; Putos, Joseph; Beattie, Tyler; MacDermid, Joy C

2016-07-01

The Brief Pain Inventory (BPI-SF) is a widely-used generic pain interference scale, however its factor structure remains unclear. An expanded 10-item version of the Interference subscale has been proposed, but the additional value of the 3 extra items has not been rigorously evaluated. The purpose of this study was to evaluate and contrast the factorial and concurrent validity of the original 7-item and 10-item versions of the BPI-SF in a large heterogeneous sample of patients with chronic pain. Exploratory and confirmatory factor analyses were conducted on independent subsets of the sample, and concurrent correlations with scales capturing similar constructs were evaluated. Two independent exploratory factor analyses (n=500 each) supported a single interference factor in both the 7- and 10-item versions, while confirmatory factor analysis (N=1000) suggested that a 2-factor structure (Physical and Affective) provided better fit. A 3-factor model, where sleep interference was the third factor, improved in model fit further. There was no significant difference in model fit between the 7- and 10-item versions. Concurrent associations with measures of general health, pain intensity and pain-related cognitions were all in the anticipated direction and magnitude and were not different by version of the BPI-SF. The addition of 3 extra items to the original 7-item Interference subscale of the BPI-SF did not improve psychometric properties. The combined results lead us to endorse a 3-factor structure (Physical, Affective, and Sleep Interference) as the more statistically and conceptually sound option. Copyright © 2016 Scandinavian Association for the Study of Pain. Published by Elsevier B.V. All rights reserved.

On-Orbit 3-Dimensional Electrostatic Detumble for Generic Spacecraft Geometries

NASA Astrophysics Data System (ADS)

Bennett, Trevor J.

In recent years, there is a growing interest in active debris removal and on-orbit servicing of Earth orbiting assets. The growing need for such approaches is often exemplified by the Iridium-Kosmos collision in 2009 that generated thousands of debris fragments. There exists a variety of active debris removal and on-orbit servicing technologies in development. Conventional docking mechanisms and mechanical capture by actuated manipulators, exemplified by NASA's Restore-L mission, require slow target tumble rates or more aggressive circumnavigation rate matching. The tumble rate limitations can be overcome with flexible capture systems such nets, harpoons, or tethers yet these systems require complex deployment, towing, and/or interfacing strategies to avoid servicer and target damage. Alternatively, touchless methods overcome the tumble rate limitations by provide detumble control prior to a mechanical interface. This thesis explores electrostatic detumble technology to touchlessly reduce large target rotation rates of Geostationary satellites and debris. The technical challenges preceding flight implementation largely reside in the long-duration formation flying guidance, navigation, and control of a servicer spacecraft equipped with electrostatic charge transfer capability. Leveraging prior research into the electrostatic charging of spacecraft, electrostatic detumble control formulations are developed for both axisymmetric and generic target geometries. A novel relative position vector and associated relative orbit control approach is created to manage the long-duration proximity operations. Through detailed numerical simulations, the proposed detumble and relative motion control formulations demonstrate detumble of several thousand kilogram spacecraft tumbling at several degrees per second in only several days. The availability, either through modeling or sensing, of the relative attitude, relative position, and electrostatic potential are among key concerns with implementation of electrostatic detumble control on-orbit. Leveraging an extended Kalman filter scheme, the relative position information is readily obtained. In order to touchlessly acquire the target electrostatic potential, a nested two-time scale Kalman filter is employed to provide real-time estimates of both relative position and electrostatic potential while on-orbit. The culmination of the presented control formulations for generic spacecraft geometries, the proximity and formation flying control capability, and the availability of necessary state information provide significant contributions towards the viability of electrostatic detumble mission concepts.

FUN3D Manual: 12.9

NASA Technical Reports Server (NTRS)

Biedron, Robert T.; Carlson, Jan-Renee; Derlaga, Joseph M.; Gnoffo, Peter A.; Hammond, Dana P.; Jones, William T.; Kleb, Bil; Lee-Rausch, Elizabeth M.; Nielsen, Eric J.; Park, Michael A.;

FUN3D Manual: 13.2

NASA Technical Reports Server (NTRS)

Biedron, Robert T.; Carlson, Jan-Renee; Derlaga, Joseph M.; Gnoffo, Peter A.; Hammond, Dana P.; Jones, William T.; Kleb, William L.; Lee-Rausch, Elizabeth M.; Nielsen, Eric J.; Park, Michael A.;

FUN3D Manual: 12.6

NASA Technical Reports Server (NTRS)

Biedron, Robert T.; Derlaga, Joseph M.; Gnoffo, Peter A.; Hammond, Dana P.; Jones, William T.; Kleb, William L.; Lee-Rausch, Elizabeth M.; Nielsen, Eric J.; Park, Michael A.; Rumsey, Christopher L.;

FUN3D Manual: 12.7

NASA Technical Reports Server (NTRS)

Biedron, Robert T.; Carlson, Jan-Renee; Derlaga, Joseph M.; Gnoffo, Peter A.; Hammond, Dana P.; Jones, William T.; Kleb, Bil; Lee-Rausch, Elizabeth M.; Nielsen, Eric J.; Park, Michael A.;

FUN3D Manual: 12.5

NASA Technical Reports Server (NTRS)

Biedron, Robert T.; Derlaga, Joseph M.; Gnoffo, Peter A.; Hammond, Dana P.; Jones, William T.; Kleb, William L.; Lee-Rausch, Elizabeth M.; Nielsen, Eric J.; Park, Michael A.; Rumsey, Christopher L.;

FUN3D Manual: 12.8

NASA Technical Reports Server (NTRS)

Biedron, Robert T.; Carlson, Jan-Renee; Derlaga, Joseph M.; Gnoffo, Peter A.; Hammond, Dana P.; Jones, William T.; Kleb, Bil; Lee-Rausch, Elizabeth M.; Nielsen, Eric J.; Park, Michael A.;

FUN3D Manual: 12.4

NASA Technical Reports Server (NTRS)

Biedron, Robert T.; Derlaga, Joseph M.; Gnoffo, Peter A.; Hammond, Dana P.; Jones, William T.; Kleb, Bil; Lee-Rausch, Elizabeth M.; Nielsen, Eric J.; Park, Michael A.; Rumsey, Christopher L.;

FUN3D Manual: 13.1

NASA Technical Reports Server (NTRS)

Biedron, Robert T.; Carlson, Jan-Renee; Derlaga, Joseph M.; Gnoffo, Peter A.; Hammond, Dana P.; Jones, William T.; Kleb, Bil; Lee-Rausch, Elizabeth M.; Nielsen, Eric J.; Park, Michael A.;

FUN3D Manual: 13.0

NASA Technical Reports Server (NTRS)

Biedron, Robert T.; Carlson, Jan-Renee; Derlaga, Joseph M.; Gnoffo, Peter A.; Hammond, Dana P.; Jones, William T.; Kleb, Bill; Lee-Rausch, Elizabeth M.; Nielsen, Eric J.; Park, Michael A.;

Chandra Interactive Analysis of Observations (CIAO)

NASA Technical Reports Server (NTRS)

Dobrzycki, Adam

2000-01-01

The Chandra (formerly AXAF) telescope, launched on July 23, 1999, provides X-rays data with unprecedented spatial and spectral resolution. As part of the Chandra scientific support, the Chandra X-ray Observatory Center provides a new data analysis system, CIAO ("Chandra Interactive Analysis of Observations"). We will present the main components of the system: "First Look" analysis; SHERPA: a multi-dimensional, multi-mission modeling and fitting application; Chandra Imaging and Plotting System; Detect package-source detection algorithms; and DM package generic data manipulation tools, We will set up a demonstration of the portable version of the system and show examples of Chandra Data Analysis.

FUN3D Manual: 13.3

NASA Technical Reports Server (NTRS)

Biedron, Robert T.; Carlson, Jan-Renee; Derlaga, Joseph M.; Gnoffo, Peter A.; Hammond, Dana P.; Jones, William T.; Kleb, Bil; Lee-Rausch, Elizabeth M.; Nielsen, Eric J.; Park, Michael A.;

Elliptic Painlevé equations from next-nearest-neighbor translations on the E_8^{(1)} lattice

NASA Astrophysics Data System (ADS)

Joshi, Nalini; Nakazono, Nobutaka

2017-07-01

The well known elliptic discrete Painlevé equation of Sakai is constructed by a standard translation on the E_8(1) lattice, given by nearest neighbor vectors. In this paper, we give a new elliptic discrete Painlevé equation obtained by translations along next-nearest-neighbor vectors. This equation is a generic (8-parameter) version of a 2-parameter elliptic difference equation found by reduction from Adler’s partial difference equation, the so-called Q4 equation. We also provide a projective reduction of the well known equation of Sakai.

A distributed Clips implementation: dClips

NASA Technical Reports Server (NTRS)

Li, Y. Philip

1993-01-01

A distributed version of the Clips language, dClips, was implemented on top of two existing generic distributed messaging systems to show that: (1) it is easy to create a coarse-grained parallel programming environment out of an existing language if a high level messaging system is used; and (2) the computing model of a parallel programming environment can be changed easily if we change the underlying messaging system. dClips processes were first connected with a simple master-slave model. A client-server model with intercommunicating agents was later implemented. The concept of service broker is being investigated.

Seismic quiescence in a frictional earthquake model

NASA Astrophysics Data System (ADS)

Braun, Oleg M.; Peyrard, Michel

2018-04-01

We investigate the origin of seismic quiescence with a generalized version of the Burridge-Knopoff model for earthquakes and show that it can be generated by a multipeaked probability distribution of the thresholds at which contacts break. Such a distribution is not assumed a priori but naturally results from the aging of the contacts. We show that the model can exhibit quiescence as well as enhanced foreshock activity, depending on the value of some parameters. This provides a generic understanding for seismic quiescence, which encompasses earlier specific explanations and could provide a pathway for a classification of faults.

Strong Cosmic Censorship

NASA Astrophysics Data System (ADS)

Isenberg, James

2017-01-01

The Hawking-Penrose theorems tell us that solutions of Einstein's equations are generally singular, in the sense of the incompleteness of causal geodesics (the paths of physical observers). These singularities might be marked by the blowup of curvature and therefore crushing tidal forces, or by the breakdown of physical determinism. Penrose has conjectured (in his `Strong Cosmic Censorship Conjecture`) that it is generically unbounded curvature that causes singularities, rather than causal breakdown. The verification that ``AVTD behavior'' (marked by the domination of time derivatives over space derivatives) is generically present in a family of solutions has proven to be a useful tool for studying model versions of Strong Cosmic Censorship in that family. I discuss some of the history of Strong Cosmic Censorship, and then discuss what is known about AVTD behavior and Strong Cosmic Censorship in families of solutions defined by varying degrees of isometry, and discuss recent results which we believe will extend this knowledge and provide new support for Strong Cosmic Censorship. I also comment on some of the recent work on ``Weak Null Singularities'', and how this relates to Strong Cosmic Censorship.

Generic Airspace Research Phase 5 Report

NASA Technical Reports Server (NTRS)

Mogford, Richard H.; Lee, Paul U.; Preston, William E.; Bridges, Wayne W.; Peknik, Dan N.; Gujral, Vimmy

2014-01-01

Human-in-the-loop testing was completed to assess the subjective preferences, usage, and operational benefits of Integrated and Separated Controller Information Tools (CITs) in support of Generic Airspace Research. Participants controlled traffic in in a busy, high altitude sector with the aid of the CITs. When the participants were asked which CIT that they preferred to use, they overwhelmingly chose the integrated version of the CIT. The primary reason for this seemed to be that it allowed participants to remain focused on the traffic situation, whereas the Standalone CIT required them to focus their attention for short periods away from the radar presentation. In contrast to their preference, there were little or no differences in the CIT usage and the operational differences. There were similar numbers of losses of separation and participants accessed each CIT equally. Although the information accessed was the similar for the two conditions, participants actively turned off the data on the Integrated CIT, presumably to reduce the clutter on the radar scope. Further work is needed to isolate which information can and should be available to controllers in the Integrated vs. Standalone format.

A knowledge-based system design/information tool

NASA Technical Reports Server (NTRS)

Allen, James G.; Sikora, Scott E.

1990-01-01

The objective of this effort was to develop a Knowledge Capture System (KCS) for the Integrated Test Facility (ITF) at the Dryden Flight Research Facility (DFRF). The DFRF is a NASA Ames Research Center (ARC) facility. This system was used to capture the design and implementation information for NASA's high angle-of-attack research vehicle (HARV), a modified F/A-18A. In particular, the KCS was used to capture specific characteristics of the design of the HARV fly-by-wire (FBW) flight control system (FCS). The KCS utilizes artificial intelligence (AI) knowledge-based system (KBS) technology. The KCS enables the user to capture the following characteristics of automated systems: the system design; the hardware (H/W) design and implementation; the software (S/W) design and implementation; and the utilities (electrical and hydraulic) design and implementation. A generic version of the KCS was developed which can be used to capture the design information for any automated system. The deliverable items for this project consist of the prototype generic KCS and an application, which captures selected design characteristics of the HARV FCS.

Implementation of the Computerized Adaptive Version of the Armed Services Vocational Aptitude Battery.

ERIC Educational Resources Information Center

Curran, Linda T.; Jordan, Linda A.

In the summer of 1996, the U.S. Armed Services will implement the computerized adaptive testing version of the Armed Services Vocational Aptitude Battery (CAT-ASVAB). When conversion is completed at the 65 targeted military entrance processing stations, about half the applicants will take this test version. This paper describes the efforts that…

Analysis of minimum target prices for production of entecavir to treat hepatitis B in high- and low-income countries.

PubMed

Hill, Andrew; Gotham, Dzintars; Cooke, Graham; Bhagani, Sanjay; Andrieux-Meyer, Isabelle; Cohn, Jennifer; Fortunak, Joseph

2015-04-01

In 2013, an estimated 686,000 people died from hepatitis B virus (HBV) infection worldwide. Mass treatment programmes for hepatitis B will require very low drug costs. International treatment guidelines recommend first-line monotherapy with either entecavir or tenofovir disoproxil fumarate (TDF). While the basic patent on TDF expires in 2017/8, entecavir is already generic in several countries, including the US. The chemical structure of entecavir is related to abacavir, which costs <$200 per person-year in low-income countries. The clinical efficacy, chemical structures, daily doses, routes of chemical synthesis, costs of raw materials and patent expiry dates were analysed for entecavir and TDF. Costs of sustainable, generic production were calculated for entecavir, and compared with published originator and generic prices in high- and low-income countries. With a daily dose of 0.5 mg, one year's supply of entecavir treatment requires <0.2 g of active pharmaceutical ingredient (API) per person, estimated to cost $4/year, based on quotations of API production from generic suppliers. With an additional $20 per year for formulation/packaging and a 50% profit margin, entecavir was estimated to cost a minimum of $36/person-year, substantially lower than current originator and generic prices. Entecavir is no longer under patent protection in the USA, China, Brazil and South Africa, with European expiry in 2017. Given differences in daily dosing, production volumes for entecavir would be 600 times lower than TDF (300 mg once daily) for treating the same numbers of patients. Mass treatment for hepatitis B with generic entecavir could be achieved at very low cost in all countries, provided that important projections can be met in terms of pricing for the API and finished dosage form.

[Competition for the promotion of essential generic drugs in Africa].

PubMed

Bruneton, C; Favre, I; Fontaine, D; Maritoux, J; Rey, J L

1999-01-01

in most sub-Saharan countries, an extensive economic crisis coupled with a low level of existing resources has put most pharmaceuticals beyond the reach of the general public. This situation was worsened by the devaluation of the Franc CFA in 1994. The supply of lowprice drugs and the improvement of rational drug use is now a priority. Unfortunately, essential generic drugs are little known and used in Africa. 1. To improve the knowledge of and confidence in essential and generic drugs among providers, prescribers and consumers, through the participation of the general public in an incentive-based, creative competition; 2. To collect locally-adapted promotional material, to be used in the future promotion of essential and generic drugs in Africa. Design, setting and method: a competition was announced in June 1995, via various networks, in French-speaking Africa: the population was invited to create one or several items promoting essential generic drugs. These items included slogans, posters, songs and short plays. Over 550 entries were received before the deadline (15 October 1995), from 22 countries (mostly Sub-Saharan and French-speaking). The entries included 387 slogans, 94 posters, 22 plays, and various (photos, comic strips, songs, poems). 1. Greater awareness of essential generic drugs in Western Africa, through the publicity given to the competition; 2. Selection of a pool of approximately 200 promotional items, produced by the target populations, to be published in a catalog and distributed in African countries; 3. Insights into popular practices and representations of Western medications, and local re-interpretation of the concept. this public competition was effective at achieving three important goals: 1. Dynamic promotion (the competition was the opportunity for school projects, radio talkshows, etc. on generic drugs); 2. Re appropriation of a policy, thanks to a participative approach; 3. Analysis of the population's general comprehension of pharmaceuticals, through analysis of competition entries.

The generic danger and the idiosyncratic support

NASA Astrophysics Data System (ADS)

Temme, Arnaud; Nijp, Jelmer; van der Meij, Marijn; Samia, Jalal; Masselink, Rens

2016-04-01

This contribution argues two main points. First, that generic landscapes used in some modelling studies sometimes have properties or cause simulation results that are unrealistic. Such initially flat or straight-sloped landscapes, sometimes with minor random perturbations, e.g. form the backdrop for ecological simulations of vegetation growth and competition that predict catastrophic shifts. Exploratory results for semi-arid systems suggest that the results based on these generic landscapes are end-members from a distribution of results, rather than an unbiased, typical outcome. Apparently, the desire to avoid idiosyncrasy has unintended consequences. Second, we argue and illustrate that in fact new insights often come from close inspection of idiosyncratic case studies. Our examples from landslide systems, connectivity and soil formation show how a central role for the case study - either in empirical work or to provide model targets - has advanced our understanding. Both points contribute to the conclusion that it is dangerous to forget about annoying, small-scale, idiosyncratic and, indeed, perhaps bad-ass case studies in Earth Sciences.

The effects of drug market regulation on pharmaceutical prices in Europe: overview and evidence from the market of ACE inhibitors

PubMed Central

2011-01-01

This study provides an overview of policy measures targeting pharmaceutical expenditure in Europe and analyses their impact on originator pharmaceutical prices. Panel data methods are used to examine the market of ACE Inhibitors in six European countries (Denmark, France, Germany, Netherlands, Sweden, United Kingdom) over period 1991-2006. We find that although some measures are effective in reducing originator prices, others appear to have an insignificant effect. Results suggest that supply side measures such as mandatory generic substitution, regressive pharmacy mark-ups and claw-backs are effective in reducing pharmaceuticals prices. Results are not as strong for demand side measures. Profit controls and the use of cost-effectiveness analysis appear to have a negative effect on prices, while results on reference pricing are inconclusive. Findings also indicate that, although originator prices are not immediately affected by generic entry, they may be influenced by changes in generic prices post patent expiry. PMID:22828053

Evaluation of the clinical and economic impact of a brand name-to-generic warfarin sodium conversion program.

PubMed

Witt, Daniel M; Tillman, Donald J; Evans, Christy M; Plotkin, Tatyana V; Sadler, Melanie A

2003-03-01

Substitution of generic warfarin initially was discouraged because of concerns regarding therapeutic failure or toxicity. Although subsequent research with AB-rated (i.e., bioequivalent) warfarin did not confirm initial concerns, the issue is not settled for all clinicians. We sought to provide additional information regarding the clinical and economic impact of warfarin conversion by analyzing a real-life sample of patients receiving long-term anticoagulation therapy who were switched from brand name to generic warfarin. Patients who had been taking warfarin for at least 180 days and had received uninterrupted oral anticoagulation 90 days before and 90 days after switching to generic warfarin were included. The switch date was based on the first time generic warfarin was dispensed from our pharmacies. The primary end point was the calculated amount of time each patient's international normalized ratio (INR) values were within the patient-specific target INR range in the 90 days before and after the switch. Data regarding adverse events and medical resource utilization were also collected. Pharmacoeconomic analyses were performed. The analysis included 2299 patients. The overall difference in calculated time INR values were below (22.6% before vs 26.1% after switch, p<0.0001) and within (65.9% before vs 63.3% after switch, p=0.0002) the therapeutic INR range was statistically but not clinically significant. Only 28.0% of patients experienced a change in therapeutic INR control of 10% or less, 33.1% experienced INR control that improved by greater than 10%, and 38.9% experienced INR control that worsened by more than 10%. The difference in total treatment costs associated with brand name and generic warfarin was 3128 dollars/100 patient-years in favor of the generic product. Sensitivity analyses revealed that cost savings associated with warfarin conversion in this health care system were highly dependent on the difference between warfarin costs and cost of treating anticoagulation-related adverse events. Most of these patients were successfully switched from brand name to generic warfarin. However, supplemental INR monitoring is warranted when one warfarin product is substituted for another to allow timely detection of those patients who experience significant changes in anticoagulation response.

Development and regulation of biosimilars: current status and future challenges.

PubMed

Tsiftsoglou, Asterios S; Ruiz, Sol; Schneider, Christian K

2013-06-01

Biologic medicinal products developed via rDNA technology as recombinant protein-based medicines that have been in clinical use since the early 1980s as original biopharmaceuticals have greatly contributed to the therapy of severe metabolic and degenerative diseases. The recent expiration of the data protection or patents for most of them created opportunities for the development of copy versions of original biopharmaceuticals with similar biologic activity (termed biosimilars). Production of these new products is expected to meet worldwide demand, promote market competition, maintain the incentives for innovation, and sustain the healthcare systems. The licencing of these products, however, relies on the experience gained with the original biopharmaceuticals. Critical issues related to this class of medicinal products include their terminology (to avoid confusion with generics and non-innovator copy versions that have not been tested according to the biosimilar guidelines), manufacturing, and regulation. The European Union (EU) has been the first to establish a regulatory framework for marketing authorization application (MAA) and has named these products biosimilars, a term also recently adopted by the US FDA. Unlike the conventional, more common small molecular weight human medicines and chemical generics, protein-based medicines exhibit higher molecular weight, complexity in structure and function that can be affected by changes in the manufacturing process. Therefore, biosimilars represent a relatively heterogeneous class of medicinal products that make their regulation quite challenging. According to the current understanding in the EU, a biosimilar is a copy version of an already authorized biopharmaceutical (or reference product) with similar biologic activity, physicochemical characteristics, efficacy, and safety, based on a full comparability exercise at quality, preclinical and clinical level to ensure similar efficacy and safety. Guidance has been provided through several Committee for Medicinal Products for Human Use (CHMP) guidelines as well as individual scientific advice requested from the European Medicines Agency (EMA) by various companies for the development and regulation of biosimilars. This review is mainly focused on the current status of regulation of biosimilars in the EU as well as on future challenges lying ahead for the improvement of the requirements needed for the marketing authorization of biosimilars. Emphasis is given on the quality requirements concerning these medicinal products (biologics).

Validation of the Japanese version of the Pediatric Quality of Life Inventory (PedsQL) Cancer Module.

PubMed

Tsuji, Naoko; Kakee, Naoko; Ishida, Yasushi; Asami, Keiko; Tabuchi, Ken; Nakadate, Hisaya; Iwai, Tsuyako; Maeda, Miho; Okamura, Jun; Kazama, Takuro; Terao, Yoko; Ohyama, Wataru; Yuza, Yuki; Kaneko, Takashi; Manabe, Atsushi; Kobayashi, Kyoko; Kamibeppu, Kiyoko; Matsushima, Eisuke

2011-04-10

The PedsQL 3.0 Cancer Module is a widely used instrument to measure pediatric cancer specific health-related quality of life (HRQOL) for children aged 2 to 18 years. We developed the Japanese version of the PedsQL Cancer Module and investigated its reliability and validity among Japanese children and their parents. Participants were 212 children with cancer and 253 of their parents. Reliability was determined by internal consistency using Cronbach's coefficient alpha and test-retest reliability using intra-class correlation coefficient (ICC). Validity was assessed through factor validity, convergent and discriminant validity, concurrent validity, and clinical validity. Factor validity was examined by exploratory factor analysis. Convergent and discriminant validity were examined by multitrait scaling analysis. Concurrent validity was assessed using Spearman's correlation coefficients between the Cancer Module and Generic Core Scales, and the comparison of the scores of child self-reports with those of other self-rating depression scales for children. Clinical validity was assessed by comparing the on- and off- treatment scores using Kruskal-Wallis and Mann-Whitney U tests. Cronbach's coefficient alpha was over 0.70 for the total scale and over 0.60 for each subscale by age except for the 'pain and hurt' subscale for children aged 5 to 7 years. For test-retest reliability, the ICC exceeded 0.70 for the total scale for each age. Exploratory factor analysis demonstrated sufficient factorial validity. Multitrait scaling analysis showed high success rates. Strong correlations were found between the reports by children and their parents, and the scores of the Cancer Module and the Generic Core Scales except for 'treatment anxiety' subscales for child reports. The Depression Self-Rating Scale for Children (DSRS-C) scores were significantly correlated with emotional domains and the total score of the cancer module. Children who had been off treatment over 12 months demonstrated significantly higher scores than those on treatment. The results demonstrate the reliability and validity of the Japanese version of the PedsQL Cancer Module among Japanese children.

Determinants of Market Exclusivity for Prescription Drugs in the United States.

PubMed

Kesselheim, Aaron S; Sinha, Michael S; Avorn, Jerry

2017-11-01

The high prices of brand-name prescription drugs are a growing source of controversy in the United States. Manufacturers of brand-name drugs can command high prices because they are protected from generic competition by two types of government-granted monopoly rights. The first are patents on the drugs that generally define the basic period of brand-name-only sales. The second is awarded at the time of US Food and Drug Administration (FDA) approval and usually defines the minimum time until a generic can be sold. The initial patents last for 20 years and may be extended to account for time spent in clinical trials and regulatory review; other laws prevent approval of other manufacturers' versions of new drugs for about 6 to 7 years, and for new biologics for 12 years. Overall, most new drugs receive about 12 to 16 years of market exclusivity from both kinds of monopoly protection combined. We reviewed the peer-reviewed medical and health policy literature to identify studies that described the different types of patent protection and regulatory exclusivities that shield brand-name prescription drugs from competition and thus help to sustain high drug prices. We also identified potential policy reforms intended to modify exclusivity periods to address public health needs by balancing drug affordability and industry revenue. The goal of policy in this area should be to ensure that drug market exclusivity periods provide for fair return on investment but do not indefinitely block availability of lower-cost generic drugs.

Biosimilar therapeutics-what do we need to consider?

PubMed

Schellekens, Huub

2009-01-01

Patents for the first generation of approved biopharmaceuticals have either expired or are about to expire. Thus the market is opening for generic versions, referred to as 'biosimilars' (European Union) or 'follow-on protein products' (United States). Healthcare professionals need to understand the critical issues surrounding the use of biosimilars to make informed treatment decisions.The complex high-molecular-weight three-dimensional structures of biopharmaceuticals, their heterogeneity and dependence on production in living cells makes them different from classical chemical drugs. Current analytical methods cannot characterize these complex molecules sufficiently to confirm structural equivalence with reference molecules. Verification of the similarity of biosimilars to innovator biopharmaceuticals remains a key challenge. Furthermore, a critical safety issue, the immunogenicity of biopharmaceuticals, has been highlighted in recent years, confirming a need for comprehensive immunogenicity testing prior to approval and extended post-marketing surveillance.Biosimilars present a new set of challenges for regulatory authorities when compared with conventional generics. While the demonstration of a pharmacokinetic similarity is sufficient for conventional, small-molecule generic agents, a number of issues will make the approval of biosimilars more complicated. Documents recently published by the European Medicines Agency (EMEA) outlining requirements for the market approval of biosimilars provide much-needed guidance. The EMEA has approved a number of biosimilar products in a scientifically rigorous and balanced process. Outstanding issues include the interchangeability of biosimilars and innovator products, the possible need for unique naming to differentiate the various biopharmaceutical products, and more comprehensive labelling for biosimilars to include relevant clinical data.

Designing of a Digital Behind-the-Ear Hearing Aid to Meet the World Health Organization Requirements

PubMed Central

Bento, Ricardo Ferreira; Penteado, Silvio Pires

2010-01-01

Hearing loss is a common health issue that affects nearly 10% of the world population as indicated by many international studies. The hearing impaired typically experience more frustration, anxiety, irritability, depression, and disorientation than those with normal hearing levels. The standard rehabilitation tool for hearing impairment is an electronic hearing aid whose main components are transducers (microphone and receiver) and a digital signal processor. These electronic components are manufactured by supply chain rather than by hearing aid manufacturers. Manufacturers can use custom-designed components or generic off-the-shelf components. These electronic components are available as application-specific or off-the-shelf products, with the former designed for a specific manufacturer and the latter for a generic approach. The choice of custom or generic components will affect the product specifications, pricing, manufacturing, life cycle, and marketing strategies of the product. The World Health Organization is interested in making available to developing countries hearing aids that are inexpensive to purchase and maintain. The hearing aid presented in this article was developed with these specifications in mind together with additional contemporary features such as four channels with wide dynamic range compression, an adjustable compression rate for each channel, four comfort programs, an adaptive feedback manager, and full volume control. This digital hearing aid is fitted using a personal computer with minimal hardware requirements in intuitive three-step fitting software. A trimmer-adjusted version can be developed where human and material resources are scarce. PMID:20724354

Cross-cultural adaptation and measurement properties of generic and cancer-related patient-reported outcome measures (PROMs) for use with cancer patients in Brazil: a systematic review.

PubMed

Albach, Carlos Augusto; Wagland, Richard; Hunt, Katherine J

2018-04-01

This systematic review (1) identifies the current generic and cancer-related patient-reported outcome measures (PROMs) that have been cross-culturally adapted to Brazilian Portuguese and applied to cancer patients and (2) critically evaluates their cross-cultural adaptation (CCA) and measurement properties. Seven databases were searched for articles regarding the translation and evaluation of measurement properties of generic and cancer-related PROMs cross-culturally adapted to Brazilian Portuguese that are applied in adult (≥18 years old) cancer patients. The methodological quality of included studies was assessed using the COSMIN checklist. The bibliographic search retrieved 1674 hits, of which seven studies analysing eight instruments were included in this review. Data on the interpretability of scores were poorly reported. Overall, the quality of the CCA process was inconsistent throughout the studies. None of the included studies performed a cross-cultural validation. The evidence concerning the quality of measurement properties is limited by poor or fair methodological quality. Moreover, limited information regarding measurement properties was provided within the included papers. This review aids the selection process of Brazilian Portuguese PROMs for use in cancer patients. After acknowledging the methodological caveats and strengths of each tool, our opinion is that for quality of life and symptoms assessment the adapted FACT-G version and the ESAS could be recommended, respectively. Future research should rely on the already accepted standards of CCA and validation studies.

Development and application of Model of Resource Utilization, Costs, and Outcomes for Stroke (MORUCOS): an Australian economic model for stroke.

PubMed

Mihalopoulos, Catherine; Cadilhac, Dominique A; Moodie, Marjory L; Dewey, Helen M; Thrift, Amanda G; Donnan, Geoffrey A; Carter, Robert C

2005-01-01

To outline the development, structure, data assumptions, and application of an Australian economic model for stroke (Model of Resource Utilization, Costs, and Outcomes for Stroke [MORUCOS]). The model has a linked spreadsheet format with four modules to describe the disease burden and treatment pathways, estimate prevalence-based and incidence-based costs, and derive life expectancy and quality of life consequences. The model uses patient-level, community-based, stroke cohort data and macro-level simulations. An interventions module allows options for change to be consistently evaluated by modifying aspects of the other modules. To date, model validation has included sensitivity testing, face validity, and peer review. Further validation of technical and predictive accuracy is needed. The generic pathway model was assessed by comparison with a stroke subtypes (ischemic, hemorrhagic, or undetermined) approach and used to determine the relative cost-effectiveness of four interventions. The generic pathway model produced lower costs compared with a subtypes version (total average first-year costs/case AUD$ 15,117 versus AUD$ 17,786, respectively). Optimal evidence-based uptake of anticoagulation therapy for primary and secondary stroke prevention and intravenous thrombolytic therapy within 3 hours of stroke were more cost-effective than current practice (base year, 1997). MORUCOS is transparent and flexible in describing Australian stroke care and can effectively be used to systematically evaluate a range of different interventions. Adjusting results to account for stroke subtypes, as they influence cost estimates, could enhance the generic model.

Designing of a digital behind-the-ear hearing aid to meet the World Health Organization requirements.

PubMed

Bento, Ricardo Ferreira; Penteado, Silvio Pires

2010-06-01

Hearing loss is a common health issue that affects nearly 10% of the world population as indicated by many international studies. The hearing impaired typically experience more frustration, anxiety, irritability, depression, and disorientation than those with normal hearing levels. The standard rehabilitation tool for hearing impairment is an electronic hearing aid whose main components are transducers (microphone and receiver) and a digital signal processor. These electronic components are manufactured by supply chain rather than by hearing aid manufacturers. Manufacturers can use custom-designed components or generic off-the-shelf components. These electronic components are available as application-specific or off-the-shelf products, with the former designed for a specific manufacturer and the latter for a generic approach. The choice of custom or generic components will affect the product specifications, pricing, manufacturing, life cycle, and marketing strategies of the product. The World Health Organization is interested in making available to developing countries hearing aids that are inexpensive to purchase and maintain. The hearing aid presented in this article was developed with these specifications in mind together with additional contemporary features such as four channels with wide dynamic range compression, an adjustable compression rate for each channel, four comfort programs, an adaptive feedback manager, and full volume control. This digital hearing aid is fitted using a personal computer with minimal hardware requirements in intuitive three-step fitting software. A trimmer-adjusted version can be developed where human and material resources are scarce.

21 CFR 886.1810 - Tangent screen (campimeter).

Code of Federal Regulations, 2010 CFR

2010-04-01

... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Tangent screen (campimeter). 886.1810 Section 886.1810 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED... a patient's visual field. This generic type of device includes projection tangent screens, target...

21 CFR 886.1810 - Tangent screen (campimeter).

Code of Federal Regulations, 2013 CFR

2013-04-01

...) Identification. A tangent screen (campimeter) is an AC-powered or battery-powered device that is a large square... a patient's visual field. This generic type of device includes projection tangent screens, target... (general controls). The AC-powered device and the battery-powered device are exempt from the premarket...

21 CFR 886.1810 - Tangent screen (campimeter).

Code of Federal Regulations, 2012 CFR

2012-04-01

...) Identification. A tangent screen (campimeter) is an AC-powered or battery-powered device that is a large square... a patient's visual field. This generic type of device includes projection tangent screens, target... (general controls). The AC-powered device and the battery-powered device are exempt from the premarket...

21 CFR 886.1810 - Tangent screen (campimeter).

Code of Federal Regulations, 2011 CFR

2011-04-01

...) Identification. A tangent screen (campimeter) is an AC-powered or battery-powered device that is a large square... a patient's visual field. This generic type of device includes projection tangent screens, target... (general controls). The AC-powered device and the battery-powered device are exempt from the premarket...

21 CFR 886.1810 - Tangent screen (campimeter).

Code of Federal Regulations, 2014 CFR

2014-04-01

...) Identification. A tangent screen (campimeter) is an AC-powered or battery-powered device that is a large square... a patient's visual field. This generic type of device includes projection tangent screens, target... (general controls). The AC-powered device and the battery-powered device are exempt from the premarket...

Treating the host response to emerging virus diseases: lessons learned from sepsis, pneumonia, influenza and Ebola

PubMed Central

2016-01-01

There is an ongoing threat of epidemic or pandemic diseases that could be caused by influenza, Ebola or other emerging viruses. It will be difficult and costly to develop new drugs that target each of these viruses. Statins and angiotensin receptor blockers (ARBs) have been effective in treating patients with sepsis, pneumonia and influenza, and a statin/ARB combination appeared to dramatically reduce mortality during the recent Ebola outbreak. These drugs target (among other things) the endothelial dysfunction found in all of these diseases. Most scientists work on new drugs that target viruses, and few accept the idea of treating the host response with generic drugs. A great deal of research will be needed to show conclusively that these drugs work, and this will require the support of public agencies and foundations. Investigators in developing countries should take an active role in this research. If the next Public Health Emergency of International Concern is caused by an emerging virus, a “top down” approach to developing specific new drug treatments is unlikely to be effective. However, a “bottom up” approach to treatment that targets the host response to these viruses by using widely available and inexpensive generic drugs could reduce mortality in any country with a basic health care system. In doing so, it would make an immeasurable contribution to global equity and global security. PMID:27942512

Translation, adaptation and validation of two versions of the Chronic Liver Disease Questionnaire in Malaysian patients for speakers of both English and Malay languages: a cross-sectional study.

PubMed

Khairullah, Shasha; Mahadeva, Sanjiv

2017-05-25

We aimed to adapt, translate and validate the Chronic Liver Disease Questionnaire (CLDQ) in Malaysian patients with chronic liver diseases of various aetiologies. Tertiary level teaching institution in Malaysia. The validation process involved 211 adult patients (English language n=101, Malay language n=110) with chronic liver disease. Characteristics of the study subjects were as follows: mean (SD) age was 56 (12.8) years, 58.3% were male and 41.7% female. The inclusion criteria were patients 18 years or older with chronic hepatitis and/or liver cirrhosis of any aetiology. The exclusion criteria were as follows: presence of hepatic encephalopathy, ongoing treatment with interferon and presence of other chronic conditions that have an impact on health-related quality of life (HRQOL). A cross-sectional study was conducted. Cultural adaptation of the English version of the CLDQ was performed, and a Malay version was developed following standard forward-backward translation by independent native speakers. Psychometric properties of both versions were determined by assessing their internal consistency, test-retest reliability and discriminant and convergent validity. Cronbach's alpha for internal consistency across the various domains of the CLDQ was 0.95 for the English version and 0.92 for the Malay version. Test-retest analysis showed excellent reliability with an intraclass correlation coefficient of 0.89 for the English version and 0.93 for the Malay version. The average scores of both the English and Malay versions of the CLDQ demonstrated adequate discriminant validity by differentiating between non-cirrhosis (English 6.3, Malay 6.1), compensated cirrhosis (English 5.6, Malay 6.0) and decompensated cirrhosis (English 5.1, Malay 4.9) (p<0.001). Convergent validity showed that correlation was fair between the English (ρ=0.59) and Malay (p=0.47) CLDQ versions with the EQ-5D, a generic HRQOL instrument. The English and Malay versions of the CLDQ are reliable and valid disease-specific instruments for assessing HRQOL in Malaysian patients with chronic liver disease. © 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.

Generic entry, reformulations and promotion of SSRIs in the US.

PubMed

Huskamp, Haiden A; Donohue, Julie M; Koss, Catherine; Berndt, Ernst R; Frank, Richard G

2008-01-01

Previous research has shown that a manufacturer's promotional strategy for a brand name drug is typically affected by generic entry. However, little is known about how newer strategies to extend patent life, including product reformulation introduction or obtaining approval to market for additional clinical indications, influence promotion. To examine the relationships among promotional expenditures, generic entry, reformulation entry and new indication approval. We used quarterly data on national product-level promotional spending (including expenditures for physician detailing and direct-to-consumer advertising [DTCA], and the retail value of free samples distributed in physician offices) for selective serotonin reuptake inhibitors (SSRIs) over the period 1997-2004. We estimated econometric models of detailing, DTCA and total quarterly promotional expenditures as a function of the timing of generic entry, entry of new product formulations and US FDA approval for new clinical indications for existing medications in the SSRI class. Expenditures by pharmaceutical manufacturers for promotion of antidepressant medications was the main outcome measure. Over the period 1997-2004, there was considerable variation in the composition of promotional expenditures across the SSRIs. Promotional expenditures for the original brand molecule decreased dramatically when a reformulation of the molecule was introduced. Promotional spending (both total and detailing alone) for a specific molecule was generally lower after generic entry than before, although the effect of generic entry on promotional spending appears to be closely linked with the choice of product reformulation strategy pursued by the manufacturer. Detailing expenditures for Paxil were increased after the manufacturer received FDA approval to market the drug for generalized anxiety disorder (GAD), while the likelihood of DTCA outlays for the drug was not changed. In contrast, FDA approval to market Paxil and Zoloft for social anxiety disorder (SAD) did not affect the manufacturers' detailing expenditures but did result in a greater likelihood of DTCA outlays. The introduction of new product formulations appears to be a common strategy for attempting to extend market exclusivity for medications facing impending generic entry. Manufacturers who introduced a reformulation before generic entry shifted most promotion dollars from the original brand to the reformulation long before generic entry, and in some cases manufacturers appeared to target a particular promotion type for a given indication. Given the significant impact that pharmaceutical promotion has on demand for prescription drugs in the US, these findings have important implications for prescription drug spending and public health.

[The psychometric properties of the new Turkish generic health-related quality of life questionnaire for children (Kid-KINDL)].

PubMed

Eser, Erhan; Yüksel, Hasan; Baydur, Hakan; Erhart, Michael; Saatli, Gül; Cengiz Ozyurt, Beyhan; Ozcan, Cemil; Ravens-Sieberer, Ulrike

2008-01-01

There are few health-related quality of life (HRQOL) instruments available that have been validated for use with Turkish children. The Kid-KINDL is a generic measure of children's (8-12 years) HRQOL, which contains 24 categorical items that assess 6 dimensions (physical well-being, emotional well-being, self-esteem, family, friends, and school). The Kid-KINDL is available in many languages. Following an elaborate translation procedure and cognitive focus group interviews, the Kid-KINDL was adopted into Turkish. This paper describes the psychometric properties of the new Turkish Kid-KINDL. In total, 1918 children aged 8-12 years at a school in Manisa completed the Kid-KINDL. A confirmatory approach was used for validity and reliability analysis. Using the Multi-trait/Multi-item analysis program (MAP) item-internal consistency and item-discriminant validity were calculated to confirm the instrument's structure. Likert scaling assumptions were tested and confirmatory factor analysis (CFA) was applied as well. After modification of 2 unsatisfactory items the Kid-KINDL was administered to a different group of 84 randomly selected children and the analyses were repeated. Cronbach's alpha was 0.35-0.78 before and 0.54-0.78 after the scales was modified. MAP-scaling success was 60%-100% before and 90%-100% after the modification. CFA confirmed the Kid-KINDL structure for the original version (RMSEA = 0.077) was less than the modified version (RMSEA = 0.059), although for the latter the sample was rather small. Floor effects were negligible, and ceiling effects reached 19%. The results indicate that the Turkish Kid-KINDL was a reliable and factorially valid assessment of the children's HRQOL. The modifications made to the 2 unsatisfactory items increased the psychometric quality of the scale.

Perpetual extraction of work from a nonequilibrium dynamical system under Markovian feedback control

NASA Astrophysics Data System (ADS)

Kosugi, Taichi

2013-09-01

By treating both control parameters and dynamical variables as probabilistic variables, we develop a succinct theory of perpetual extraction of work from a generic classical nonequilibrium system subject to a heat bath via repeated measurements under a Markovian feedback control. It is demonstrated that a problem for perpetual extraction of work in a nonequilibrium system is reduced to a problem of Markov chain in the higher-dimensional phase space. We derive a version of the detailed fluctuation theorem, which was originally derived for classical nonequilibrium systems by Horowitz and Vaikuntanathan [Phys. Rev. EPLEEE81539-375510.1103/PhysRevE.82.061120 82, 061120 (2010)], in a form suitable for the analyses of perpetual extraction of work. Since our theory is formulated for generic dynamics of probability distribution function in phase space, its application to a physical system is straightforward. As simple applications of the theory, two exactly solvable models are analyzed. The one is a nonequilibrium two-state system and the other is a particle confined to a one-dimensional harmonic potential in thermal equilibrium. For the former example, it is demonstrated that the observer on the transitory steps to the stationary state can lose energy and that work larger than that achieved in the stationary state can be extracted. For the latter example, it is demonstrated that the optimal protocol for the extraction of work via repeated measurements can differ from that via a single measurement. The validity of our version of the detailed fluctuation theorem, which determines the upper bound of the expected work in the stationary state, is also confirmed for both examples. These observations provide useful insights into exploration for realistic modeling of a machine that extracts work from its environment.

Psychometric evaluation of the Chinese version of the Child Health Utility 9D (CHU9D-CHN): a school-based study in China.

PubMed

Yang, Peirong; Chen, Gang; Wang, Peng; Zhang, Kejian; Deng, Feng; Yang, Haifeng; Zhuang, Guihua

2018-05-05

The Child Health Utility 9D (CHU9D), a new generic preference-based health-related quality of life (HRQoL) instrument, was developed specifically for the application in cost-effectiveness analyses of treatments and interventions for children and adolescents. The main objective of this study was to examine the psychometric property of the Chinese version of CHU9D (CHU9D-CHN) in a large school-based sample in China. Data were collected using a multi-stage sampling method from third-to-ninth-grade students in Shaanxi Province, China. Participants self-completed a hard-copy questionnaire including the CHU9D-CHN instrument, the Pediatric Quality of Life Inventory™ 4.0 Generic Core Scales (PedsQL), information on socio-demographic characteristics and self-reported health status. The psychometric properties of the CHU9D-CHN, including the internal consistency, 2-week test-retest reliability, convergent and known-groups validity were studied. A total of 1912 students participated in the survey. The CHU9D-CHN internal consistency and test-retest reliability were good to excellent with a Cronbach's alpha of 0.77 and an intra-class correlation coefficient of 0.65, respectively. The CHU9D utility scores moderately correlated with the PedsQL total scores (r = .57, P < .001), demonstrating good convergent validity. Difference of the CHU9D utility scores among the different participants with levels of self-reported general health, health services utilisation and left-behind status demonstrated good construct validity. The findings demonstrated adequate psychometric performance for the CHU9D-CHN. The CHU9D-CHN was a satisfactory, reliable and valid instrument to measure and value HRQoL for children and adolescents in China.

Affordability and availability of off-patent drugs in the United States—the case for importing from abroad: observational study

PubMed Central

Gupta, Ravi; Bollyky, Thomas J; Cohen, Matthew; Ross, Joseph S

2018-01-01

Abstract Objectives To evaluate whether off-patent prescription drugs at risk of sudden price increases or shortages in the United States are available from independent manufacturers approved in other well regulated settings around the world. Design Observational study. Setting Off-patent drugs in the USA and approved by the Food and Drug Administration, up to 10 April 2017. Study cohort Novel tablet or capsule prescription drugs approved by the FDA since 1939 that were no longer protected by patents or other market exclusivity and had up to three generic versions. Main outcome measures Number of additional manufacturers that had obtained approval from any of seven non-US regulators with similar standards (European Medicines Agency (European Union), HealthCanada (Canada), Therapeutic Goods Association (Australia), Medsafe (New Zealand), Swissmedic (Switzerland), Medicines Control Council (South Africa), and the Israel Health Ministry). Association with drug characteristics including US orphan drug designation for drugs treating rare diseases, World Health Organization essential medicine designation, treatment area, drug product complexity (that is, with attributes that could complicate establishing bioequivalence or manufacturing), and total Medicaid spending in 2015. Results Of 170 eligible study drugs, more than half (109, 64%) had at least one manufacturer approved by a non-US regulator and 32 (19%) had four or more. Among 44 (26%) drugs with no FDA approved generic versions, 21 (48%) were available from at least one manufacturer approved by one of the seven non-US regulators, and two (5%) by four or more manufacturers. Across all drugs and regulators (including the FDA), 66 (39%) drugs were available from four or more total manufacturers. Of 109 drugs with at least one non-US regulator approved manufacturer, 12 (11%) were approved for patients with rare diseases and 29 (27%) were WHO designated essential medicines; only 12 (11%) were complex products that might be more complicated to import. The highest numbers of drugs were indicated for treating cardiovascular diseases, diabetes, or hyperlipidemia (19, 17%); psychiatric disease (16, 15%); and infectious diseases (15, 14%). In 2015, Medicaid alone spent nearly US$700m (£508m; €570m) on generic drugs without adequate US competition that could have had a manufacturer approved by non-US peer regulatory agencies. Conclusion In this study, more than half the off-patent drugs with no generic competition in the USA had at least one independent manufacturer approved by a non-US peer regulatory agency; slightly fewer than half had four or more total manufacturers. Facilitating US patient access to such manufacturers could help sustain affordable access to essential off-patent drugs. PMID:29555641

Affordability and availability of off-patent drugs in the United States-the case for importing from abroad: observational study.

PubMed

Gupta, Ravi; Bollyky, Thomas J; Cohen, Matthew; Ross, Joseph S; Kesselheim, Aaron S

2018-03-19

To evaluate whether off-patent prescription drugs at risk of sudden price increases or shortages in the United States are available from independent manufacturers approved in other well regulated settings around the world. Observational study. Off-patent drugs in the USA and approved by the Food and Drug Administration, up to 10 April 2017. Novel tablet or capsule prescription drugs approved by the FDA since 1939 that were no longer protected by patents or other market exclusivity and had up to three generic versions. Number of additional manufacturers that had obtained approval from any of seven non-US regulators with similar standards (European Medicines Agency (European Union), HealthCanada (Canada), Therapeutic Goods Association (Australia), Medsafe (New Zealand), Swissmedic (Switzerland), Medicines Control Council (South Africa), and the Israel Health Ministry). Association with drug characteristics including US orphan drug designation for drugs treating rare diseases, World Health Organization essential medicine designation, treatment area, drug product complexity (that is, with attributes that could complicate establishing bioequivalence or manufacturing), and total Medicaid spending in 2015. Of 170 eligible study drugs, more than half (109, 64%) had at least one manufacturer approved by a non-US regulator and 32 (19%) had four or more. Among 44 (26%) drugs with no FDA approved generic versions, 21 (48%) were available from at least one manufacturer approved by one of the seven non-US regulators, and two (5%) by four or more manufacturers. Across all drugs and regulators (including the FDA), 66 (39%) drugs were available from four or more total manufacturers. Of 109 drugs with at least one non-US regulator approved manufacturer, 12 (11%) were approved for patients with rare diseases and 29 (27%) were WHO designated essential medicines; only 12 (11%) were complex products that might be more complicated to import. The highest numbers of drugs were indicated for treating cardiovascular diseases, diabetes, or hyperlipidemia (19, 17%); psychiatric disease (16, 15%); and infectious diseases (15, 14%). In 2015, Medicaid alone spent nearly US$700m (£508m; €570m) on generic drugs without adequate US competition that could have had a manufacturer approved by non-US peer regulatory agencies. In this study, more than half the off-patent drugs with no generic competition in the USA had at least one independent manufacturer approved by a non-US peer regulatory agency; slightly fewer than half had four or more total manufacturers. Facilitating US patient access to such manufacturers could help sustain affordable access to essential off-patent drugs. 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.

The health care and life sciences community profile for dataset descriptions

PubMed Central

Alexiev, Vladimir; Ansell, Peter; Bader, Gary; Baran, Joachim; Bolleman, Jerven T.; Callahan, Alison; Cruz-Toledo, José; Gaudet, Pascale; Gombocz, Erich A.; Gonzalez-Beltran, Alejandra N.; Groth, Paul; Haendel, Melissa; Ito, Maori; Jupp, Simon; Juty, Nick; Katayama, Toshiaki; Kobayashi, Norio; Krishnaswami, Kalpana; Laibe, Camille; Le Novère, Nicolas; Lin, Simon; Malone, James; Miller, Michael; Mungall, Christopher J.; Rietveld, Laurens; Wimalaratne, Sarala M.; Yamaguchi, Atsuko

2016-01-01

Access to consistent, high-quality metadata is critical to finding, understanding, and reusing scientific data. However, while there are many relevant vocabularies for the annotation of a dataset, none sufficiently captures all the necessary metadata. This prevents uniform indexing and querying of dataset repositories. Towards providing a practical guide for producing a high quality description of biomedical datasets, the W3C Semantic Web for Health Care and the Life Sciences Interest Group (HCLSIG) identified Resource Description Framework (RDF) vocabularies that could be used to specify common metadata elements and their value sets. The resulting guideline covers elements of description, identification, attribution, versioning, provenance, and content summarization. This guideline reuses existing vocabularies, and is intended to meet key functional requirements including indexing, discovery, exchange, query, and retrieval of datasets, thereby enabling the publication of FAIR data. The resulting metadata profile is generic and could be used by other domains with an interest in providing machine readable descriptions of versioned datasets. PMID:27602295

DOE Office of Scientific and Technical Information (OSTI.GOV)

Durt, Thomas; Fiurasek, Jaromir; Department of Optics, Palacky University, 17. listopadu 50, 77200 Olomouc

The possibility of cloning a d-dimensional quantum system without an ancilla is explored, extending on the economical phase-covariant cloning machine for qubits found in Phys. Rev. A 60, 2764 (1999). We prove the impossibility of constructing an economical version of the optimal universal 1{yields}2 cloning machine in any dimension. We also show, using an ansatz on the generic form of cloning machines, that the d-dimensional 1{yields}2 phase-covariant cloner, which optimally clones all balanced superpositions with arbitrary phases, can be realized economically only in dimension d=2. The used ansatz is supported by numerical evidence up to d=7. An economical phase-covariant clonermore » can nevertheless be constructed for d>2, albeit with a slightly lower fidelity than that of the optimal cloner requiring an ancilla. Finally, using again an ansatz on cloning machines, we show that an economical version of the 1{yields}2 Fourier-covariant cloner, which optimally clones the computational basis and its Fourier transform, is also possible only in dimension d=2.« less

The GNAT: A new tool for processing NMR data.

PubMed

Castañar, Laura; Poggetto, Guilherme Dal; Colbourne, Adam A; Morris, Gareth A; Nilsson, Mathias

2018-06-01

The GNAT (General NMR Analysis Toolbox) is a free and open-source software package for processing, visualising, and analysing NMR data. It supersedes the popular DOSY Toolbox, which has a narrower focus on diffusion NMR. Data import of most common formats from the major NMR platforms is supported, as well as a GNAT generic format. Key basic processing of NMR data (e.g., Fourier transformation, baseline correction, and phasing) is catered for within the program, as well as more advanced techniques (e.g., reference deconvolution and pure shift FID reconstruction). Analysis tools include DOSY and SCORE for diffusion data, ROSY T 1 /T 2 estimation for relaxation data, and PARAFAC for multilinear analysis. The GNAT is written for the MATLAB® language and comes with a user-friendly graphical user interface. The standard version is intended to run with a MATLAB installation, but completely free-standing compiled versions for Windows, Mac, and Linux are also freely available. © 2018 The Authors Magnetic Resonance in Chemistry Published by John Wiley & Sons Ltd.

Economical quantum cloning in any dimension

NASA Astrophysics Data System (ADS)

Durt, Thomas; Fiurášek, Jaromír; Cerf, Nicolas J.

2005-11-01

The possibility of cloning a d -dimensional quantum system without an ancilla is explored, extending on the economical phase-covariant cloning machine for qubits found in Phys. Rev. A 60, 2764 (1999). We prove the impossibility of constructing an economical version of the optimal universal 1→2 cloning machine in any dimension. We also show, using an ansatz on the generic form of cloning machines, that the d -dimensional 1→2 phase-covariant cloner, which optimally clones all balanced superpositions with arbitrary phases, can be realized economically only in dimension d=2 . The used ansatz is supported by numerical evidence up to d=7 . An economical phase-covariant cloner can nevertheless be constructed for d>2 , albeit with a slightly lower fidelity than that of the optimal cloner requiring an ancilla. Finally, using again an ansatz on cloning machines, we show that an economical version of the 1→2 Fourier-covariant cloner, which optimally clones the computational basis and its Fourier transform, is also possible only in dimension d=2 .

Raptor: An Enterprise Knowledge Discovery Engine Version 2.0

DOE Office of Scientific and Technical Information (OSTI.GOV)

2011-08-31

The Raptor Version 2.0 computer code uses a set of documents as seed documents to recommend documents of interest from a large, target set of documents. The computer code provides results that show the recommended documents with the highest similarity to the seed documents. Version 2.0 was specifically developed to work with SharePoint 2007 and MS SQL server.

Development and Command-Control Tools for Many-Robot Systems

DTIC Science & Technology

2005-01-01

been components such as pressure sensors and accelerometers for the automobile market. In fact, robots of any size have yet to appear in our daily...34 mode, so that the target hardware is neither reprogrammable nor rechargable. The goal of this paper is to propose some generic tools that the

Vigilante: Ultrafast Smart Sensor for Target Recognition and Precision Tracking in a Simulated CMD Scenario

NASA Technical Reports Server (NTRS)

Uldomkesmalee, Suraphol; Suddarth, Steven C.

1997-01-01

VIGILANTE is an ultrafast smart sensor testbed for generic Automatic Target Recognition (ATR) applications with a series of capability demonstration focussed on cruise missile defense (CMD). VIGILANTE's sensor/processor architecture is based on next-generation UV/visible/IR sensors and a tera-operations per second sugar-cube processor, as well as supporting airborne vehicle. Excellent results of efficient ATR methodologies that use an eigenvectors/neural network combination and feature-based precision tracking have been demonstrated in the laboratory environment.

Advanced Targeting Cost Function Design for Evolutionary Optimization of Control of Logistic Equation

NASA Astrophysics Data System (ADS)

Senkerik, Roman; Zelinka, Ivan; Davendra, Donald; Oplatkova, Zuzana

2010-06-01

This research deals with the optimization of the control of chaos by means of evolutionary algorithms. This work is aimed on an explanation of how to use evolutionary algorithms (EAs) and how to properly define the advanced targeting cost function (CF) securing very fast and precise stabilization of desired state for any initial conditions. As a model of deterministic chaotic system, the one dimensional Logistic equation was used. The evolutionary algorithm Self-Organizing Migrating Algorithm (SOMA) was used in four versions. For each version, repeated simulations were conducted to outline the effectiveness and robustness of used method and targeting CF.

DOE Office of Scientific and Technical Information (OSTI.GOV)

Werner, Mike

Why this utility? After years of upgrading the Java Runtime Environment (JRE) or the Java Software Development Kit (JDK/SDK), a Windows computer becomes littered with so many old versions that the machine may become a security risk due to exploits targeted at those older versions. This utility helps mitigate those vulnerabilities by searching for, and removing, versions 1.3.x thru 1.7.x of the Java JRE and/or JDK/SDK.

Translation, cultural adaptation, cross-validation of the Turkish diabetes quality-of-life (DQOL) measure.

PubMed

Yildirim, Aysegul; Akinci, Fevzi; Gozu, Hulya; Sargin, Haluk; Orbay, Ekrem; Sargin, Mehmet

2007-06-01

The aim of this study was to test the validity and reliability of the Turkish version of the diabetes quality of life (DQOL) questionnaire for use with patients with diabetes. Turkish version of the generic quality of life (QoL) scale 15D and DQOL, socio-demographics and clinical parameter characteristics were administered to 150 patients with type 2 diabetes. Study participants were randomly sampled from the Endocrinology and Diabetes Outpatient Department of Dr. Lutfi Kirdar Kartal Education and Research Hospital in Istanbul, Turkey. The Cronbach alpha coefficient of the overall DQOL scale was 0.89; the Cronbach alpha coefficient ranged from 0.80 to 0.94 for subscales. Distress, discomfort and its symptoms, depression, mobility, usual activities, and vitality on the 15 D scale had statistically significant correlations with social/vocational worry and diabetes-related worry on the DQOL scale indicating good convergent validity. Factor analysis identified four subscales: satisfaction", impact", "diabetes-related worry", and "social/vocational worry". Statistical analyses showed that the Turkish version of the DQOL is a valid and reliable instrument to measure disease related QoL in patients with diabetes. It is a simple and quick screening tool with about 15 +/- 5.8 min administration time for measuring QoL in this population.

Ada Compiler Validation Summary Report: Harris Corporation, Harris Ada Compiler, Version 1.0, Harris H1200 Host. Textronix 8540A-1750A Target.

DTIC Science & Technology

1987-06-03

REPORT - HARRIS U-1 CORPORATION HARRIS ADA COM (Ui) ADA JOINT PROGRAM OFFICE ARLINGTON VA 93 JUN 87 NC... Report : 3 June 1987 to 3 June 1988 Harris Corp., Harris Ada Compiler, Ver. 1.0, Harris H1200 Host. Tektronix 8540A-1750A Target 6. PERFORMING ORG. REPORT ...01 -07-HAR Ada ® COMPILER VALIDATION SUMMARY REPORT : Harris Corporation Harris Ada Compiler, Version 1.0 Harris H1200 Host Tektronix

Building validation tools for knowledge-based systems

NASA Technical Reports Server (NTRS)

Stachowitz, R. A.; Chang, C. L.; Stock, T. S.; Combs, J. B.

1987-01-01

The Expert Systems Validation Associate (EVA), a validation system under development at the Lockheed Artificial Intelligence Center for more than a year, provides a wide range of validation tools to check the correctness, consistency and completeness of a knowledge-based system. A declarative meta-language (higher-order language), is used to create a generic version of EVA to validate applications written in arbitrary expert system shells. The architecture and functionality of EVA are presented. The functionality includes Structure Check, Logic Check, Extended Structure Check (using semantic information), Extended Logic Check, Semantic Check, Omission Check, Rule Refinement, Control Check, Test Case Generation, Error Localization, and Behavior Verification.

Λ scattering equations

NASA Astrophysics Data System (ADS)

Gomez, Humberto

2016-06-01

The CHY representation of scattering amplitudes is based on integrals over the moduli space of a punctured sphere. We replace the punctured sphere by a double-cover version. The resulting scattering equations depend on a parameter Λ controlling the opening of a branch cut. The new representation of scattering amplitudes possesses an enhanced redundancy which can be used to fix, modulo branches, the location of four punctures while promoting Λ to a variable. Via residue theorems we show how CHY formulas break up into sums of products of smaller (off-shell) ones times a propagator. This leads to a powerful way of evaluating CHY integrals of generic rational functions, which we call the Λ algorithm.

Anomalous diffusion in a dynamical optical lattice

NASA Astrophysics Data System (ADS)

Zheng, Wei; Cooper, Nigel R.

2018-02-01

Motivated by experimental progress in strongly coupled atom-photon systems in optical cavities, we study theoretically the quantum dynamics of atoms coupled to a one-dimensional dynamical optical lattice. The dynamical lattice is chosen to have a period that is incommensurate with that of an underlying static lattice, leading to a dynamical version of the Aubry-André model which can cause localization of single-particle wave functions. We show that atomic wave packets in this dynamical lattice generically spread via anomalous diffusion, which can be tuned between superdiffusive and subdiffusive regimes. This anomalous diffusion arises from an interplay between Anderson localization and quantum fluctuations of the cavity field.

Two alternative ways for solving the coordination problem in multilevel optimization

NASA Technical Reports Server (NTRS)

Sobieszczanski-Sobieski, Jaroslaw

1991-01-01

Two techniques for formulating the coupling between levels in multilevel optimization by linear decomposition, proposed as improvements over the original formulation, now several years old, that relied on explicit equality constraints which were shown by application experience as occasionally causing numerical difficulties. The two new techniques represent the coupling without using explicit equality constraints, thus avoiding the above diffuculties and also reducing computational cost of the procedure. The old and new formulations are presented in detail and illustrated by an example of a structural optimization. A generic version of the improved algorithm is also developed for applications to multidisciplinary systems not limited to structures.

NESSUS/NASTRAN Interface (Modification of NESSUS to FORTRAN 90 Standard)

NASA Technical Reports Server (NTRS)

1997-01-01

The objective of this work has been to develop a FORTRAN 90 (F90) version of the NESSUS probabilistic analysis software, Version 6.2 with NASTRAN interface. The target platform for the modified NESSUS code is the SGI workstation.

Enabling Data Intensive Science through Service Oriented Science: Virtual Laboratories and Science Gateways

NASA Astrophysics Data System (ADS)

Lescinsky, D. T.; Wyborn, L. A.; Evans, B. J. K.; Allen, C.; Fraser, R.; Rankine, T.

2014-12-01

We present collaborative work on a generic, modular infrastructure for virtual laboratories (VLs, similar to science gateways) that combine online access to data, scientific code, and computing resources as services that support multiple data intensive scientific computing needs across a wide range of science disciplines. We are leveraging access to 10+ PB of earth science data on Lustre filesystems at Australia's National Computational Infrastructure (NCI) Research Data Storage Infrastructure (RDSI) node, co-located with NCI's 1.2 PFlop Raijin supercomputer and a 3000 CPU core research cloud. The development, maintenance and sustainability of VLs is best accomplished through modularisation and standardisation of interfaces between components. Our approach has been to break up tightly-coupled, specialised application packages into modules, with identified best techniques and algorithms repackaged either as data services or scientific tools that are accessible across domains. The data services can be used to manipulate, visualise and transform multiple data types whilst the scientific tools can be used in concert with multiple scientific codes. We are currently designing a scalable generic infrastructure that will handle scientific code as modularised services and thereby enable the rapid/easy deployment of new codes or versions of codes. The goal is to build open source libraries/collections of scientific tools, scripts and modelling codes that can be combined in specially designed deployments. Additional services in development include: provenance, publication of results, monitoring, workflow tools, etc. The generic VL infrastructure will be hosted at NCI, but can access alternative computing infrastructures (i.e., public/private cloud, HPC).The Virtual Geophysics Laboratory (VGL) was developed as a pilot project to demonstrate the underlying technology. This base is now being redesigned and generalised to develop a Virtual Hazards Impact and Risk Laboratory (VHIRL); any enhancements and new capabilities will be incorporated into a generic VL infrastructure. At same time, we are scoping seven new VLs and in the process, identifying other common components to prioritise and focus development.

Development and Validation of a Novel Generic Health-related Quality of Life Instrument With 20 Items (HINT-20)

PubMed Central

2017-01-01

Objectives Few attempts have been made to develop a generic health-related quality of life (HRQoL) instrument and to examine its validity and reliability in Korea. We aimed to do this in our present study. Methods After a literature review of existing generic HRQoL instruments, a focus group discussion, in-depth interviews, and expert consultations, we selected 30 tentative items for a new HRQoL measure. These items were evaluated by assessing their ceiling effects, difficulty, and redundancy in the first survey. To validate the HRQoL instrument that was developed, known-groups validity and convergent/discriminant validity were evaluated and its test-retest reliability was examined in the second survey. Results Of the 30 items originally assessed for the HRQoL instrument, four were excluded due to high ceiling effects and six were removed due to redundancy. We ultimately developed a HRQoL instrument with a reduced number of 20 items, known as the Health-related Quality of Life Instrument with 20 items (HINT-20), incorporating physical, mental, social, and positive health dimensions. The results of the HINT-20 for known-groups validity were poorer in women, the elderly, and those with a low income. For convergent/discriminant validity, the correlation coefficients of items (except vitality) in the physical health dimension with the physical component summary of the Short Form 36 version 2 (SF-36v2) were generally higher than the correlations of those items with the mental component summary of the SF-36v2, and vice versa. Regarding test-retest reliability, the intraclass correlation coefficient of the total HINT-20 score was 0.813 (p<0.001). Conclusions A novel generic HRQoL instrument, the HINT-20, was developed for the Korean general population and showed acceptable validity and reliability. PMID:28173686

Validation of the Polish version of Diabetes Quality of Life - Brief Clinical Inventory (DQL-BCI) among patients with type 2 diabetes.

PubMed

Dudzińska, Marta; Tarach, Jerzy S; Burroughs, Thomas E; Zwolak, Agnieszka; Matuszek, Beata; Smoleń, Agata; Nowakowski, Andrzej

2014-10-27

The aim of the study was to develop a Polish version of the Diabetes Quality of Life Brief Clinical Inventory (DQL-BCI) and to perform validating evaluation of selected psychometric aspects. The translation process was performed in accordance with generally accepted international principles of translation and cultural adaptation of measurement tools. Two hundred and seventy-four subjects with type 2 diabetes completed the Polish version of DQL-BCI, the generic EQ-5D questionnaire and the diabetes-specific DSC-R. The examination provides information about the reliability (internal consistency, test-retest) and the construct validity of the studied tool (the relationship between the DQL-BCI score and EQ-5D and DSC-R scales, as well as selected clinical patient characteristics). Cronbach's α (internal consistency) for the translated version of DQL-BCI was 0.76. Test-retest Pearson correlation coefficient was 0.96. Spearman's coefficient correlation between DQL-BCI score and EQ-5D index and EQ-VAS were 0.6 (p = 0.0000001) and 0.61 (p = 0.0000001) respectively. The correlation between scores of the examined tool and DSC-R total score was -0.6 (p = 0.0000001). Quality of life was lower among patients with microvascular as well as macrovascular complications and with occurring hypoglycemic episodes. The result of this study is the Polish scale used to test the quality of life of patients with diabetes, which includes the range of problems faced by patients while maintaining a patient-friendly form. High reliability of the scale and good construct validity qualify the Polish version of DQL-BCI as a reliable tool in both research and individual diagnostics.

Validation of the Polish version of Diabetes Quality of Life – Brief Clinical Inventory (DQL-BCI) among patients with type 2 diabetes

PubMed Central

Tarach, Jerzy S.; Burroughs, Thomas E.; Zwolak, Agnieszka; Matuszek, Beata; Smoleń, Agata; Nowakowski, Andrzej

2014-01-01

Introduction The aim of the study was to develop a Polish version of the Diabetes Quality of Life Brief Clinical Inventory (DQL-BCI) and to perform validating evaluation of selected psychometric aspects. Material and methods The translation process was performed in accordance with generally accepted international principles of translation and cultural adaptation of measurement tools. Two hundred and seventy-four subjects with type 2 diabetes completed the Polish version of DQL-BCI, the generic EQ-5D questionnaire and the diabetes-specific DSC-R. The examination provides information about the reliability (internal consistency, test-retest) and the construct validity of the studied tool (the relationship between the DQL-BCI score and EQ-5D and DSC-R scales, as well as selected clinical patient characteristics). Results Cronbach's α (internal consistency) for the translated version of DQL-BCI was 0.76. Test-retest Pearson correlation coefficient was 0.96. Spearman's coefficient correlation between DQL-BCI score and EQ-5D index and EQ-VAS were 0.6 (p = 0.0000001) and 0.61 (p = 0.0000001) respectively. The correlation between scores of the examined tool and DSC-R total score was –0.6 (p = 0.0000001). Quality of life was lower among patients with microvascular as well as macrovascular complications and with occurring hypoglycemic episodes. Conclusions The result of this study is the Polish scale used to test the quality of life of patients with diabetes, which includes the range of problems faced by patients while maintaining a patient-friendly form. High reliability of the scale and good construct validity qualify the Polish version of DQL-BCI as a reliable tool in both research and individual diagnostics. PMID:25395940

Discriminating between camouflaged targets by their time of detection by a human-based observer assessment method

NASA Astrophysics Data System (ADS)

Selj, G. K.; Søderblom, M.

2015-10-01

Detection of a camouflaged object in natural sceneries requires the target to be distinguishable from its local background. The development of any new camouflage pattern therefore has to rely on a well-founded test methodology - which has to be correlated with the final purpose of the pattern - as well as an evaluation procedure, containing the optimal criteria for i) discriminating between the targets and then eventually ii) for a final rank of the targets. In this study we present results from a recent camouflage assessment trial where human observers were used in a search by photo methodology to assess generic test camouflage patterns. We conducted a study to investigate possible improvements in camouflage patterns for battle dress uniforms. The aim was to do a comparative study of potential, and generic patterns intended for use in arid areas (sparsely vegetated, semi desert). We developed a test methodology that was intended to be simple, reliable and realistic with respect to the operational benefit of camouflage. Therefore we chose to conduct a human based observer trial founded on imagery of realistic targets in natural backgrounds. Inspired by a recent and similar trial in the UK, we developed new and purpose-based software to be able to conduct the observer trial. Our preferred assessment methodology - the observer trial - was based on target recordings in 12 different, but operational relevant scenes, collected in a dry and sparsely vegetated area (Rhodes). The scenes were chosen with the intention to span as broadly as possible. The targets were human-shaped mannequins and were situated identically in each of the scenes to allow for a relative comparison of camouflage effectiveness in each scene. Test of significance, among the targets' performance, was carried out by non-parametric tests as the corresponding time of detection distributions in overall were found to be difficult to parameterize. From the trial, containing 12 different scenes from sparsely vegetated areas we collected detection time's distributions for 6 generic targets through visual search by 148 observers. We found that the different targets performed differently, given by their corresponding time of detection distributions, within a single scene. Furthermore, we gained an overall ranking over all the 12 scenes by performing a weighted sum over all scenes, intended to keep as much of the vital information on the targets' signature effectiveness as possible. Our results show that it was possible to measure the targets performance relatively to another also when summing over all scenes. We also compared our ranking based on our preferred criterion (detection time) with a secondary (probability of detection) to assess the sensitivity of a final ranking based upon the test set-up and evaluation criterion. We found our observer-based approach to be well suited regarding its ability to discriminate between similar targets and to assign numeric values to the observed differences in performance. We believe our approach will be well suited as a tool whenever different aspects of camouflage are to be evaluated and understood further.

Proactive and coactive interference in age-related performance in a recognition-based operation span task.

PubMed

Zeintl, Melanie; Kliegel, Matthias

2010-01-01

Generally, older adults perform worse than younger adults in complex working memory span tasks. So far, it is unclear which processes mainly contribute to age-related differences in working memory span. The aim of the present study was to investigate age effects and the roles of proactive and coactive interference in a recognition-based version of the operation span task. Younger and older adults performed standard versions and distracter versions of the operation span task. At retrieval, participants had to recognize target words in word lists containing targets as well as proactive and/or coactive interference-related lures. Results show that, overall, younger adults outperformed older adults in the recognition of target words. Furthermore, analyses of error types indicate that, while younger adults were only affected by simultaneously presented distracter words, older adults had difficulties with both proactive and coactive interference. Results suggest that age effects in complex span tasks may not be mainly due to retrieval deficits in old age. Copyright 2009 S. Karger AG, Basel.

Adverse events, bone mineral density and discontinuation associated with generic alendronate among postmenopausal women previously tolerant of brand alendronate: a retrospective cohort study

PubMed Central

2010-01-01

Background A rise in gastrointestinal (GI) adverse events (AEs) and a decline in bone mineral density (BMD) was observed in patients previously tolerant to brand alendronate shortly after generic versions were introduced in July 2005 to the Canadian market. The objective of our study was to quantify changes in AE rates and BMD scores, as well as associated alendronate discontinuation among patients before and after switch from brand to generic alendronate. Methods A chart review of postmenopausal women 50 years of age and older between 2003 and 2007 was conducted in two specialized tertiary care referral centers. Patients on alendronate both before and after July 2005 were included. The change in the number of AEs, changes in BMD and associated alendronate discontinuation was compared before and after the switch from brand to generic alendronate. Results 301 women with an average age of 67.6 years (standard deviation (SD) = 9.5) had a total of 47 AEs between July 2003 and December 2007 that resulted in discontinuation of the medication. There was a significant increase in the rate of AEs per patient-months-at-risk from 0.0001 before to 0.0044 after October 2005 (p < 0.001). The most common AEs were GI in nature (stomach pain, GI upset, nausea, and reflux). In addition, 23 patients discontinued alendronate due to BMD reduction after January 2006. In these patients, BMD scores were significantly reduced from their prior BMD measures (change of -0.0534, p < 0.001 for spine BMD and change of -0.0338, p = 0.01 for femur BMD). Among patients who discontinued due to BMD reduction, BMD was stable in the period prior to January 2006 (change of -0.0066, p = 0.5 for spine BMD and change of 0.0011, p = 0.9 for femur BMD); however, testing for reduction after January 2006 in BMD measures (one-sided T-test) revealed there was a significant reduction in BMD scores for both anatomic sites (change of -0.0321, p = .005 for spine, change of -0.0205, p = 0.05 for femur). Conclusions Patients who were previously stable on doses of brand alendronate experienced an increase in AEs causing discontinuation after introduction of automatic substitution to generic alendronate. In addition, reductions in BMD were observed in some patients who had stable BMDs before January 2006. Given the substantial increase in AEs, generic alendronate may not be as well tolerated as brand alendronate. PMID:20388226

Hierarchy Software Development Framework (h-dp-fwk) project

NASA Astrophysics Data System (ADS)

Zaytsev, A.

2010-04-01

Hierarchy Software Development Framework provides a lightweight tool for building portable modular applications for performing automated data analysis tasks in a batch mode. The history of design and development activities devoted to the project has begun in March 2005 and from the very beginning it was targeting the case of building experimental data processing applications for the CMD-3 experiment which is being commissioned at Budker Institute of Nuclear Physics (BINP, Novosibirsk, Russia). Its design addresses the generic case of modular data processing application operating within the well defined distributed computing environment. The main features of the framework are modularity, built-in message and data exchange mechanisms, XInclude and XML schema enabled XML configuration management tools, dedicated log management tools, internal debugging tools, both dynamic and static module chains support, internal DSO version and consistency checking, well defined API for developing specialized frameworks. It is supported on Scientific Linux 4 and 5 and planned to be ported to other platforms as well. The project is provided with the comprehensive set of technical documentation and users' guides. The licensing schema for the source code, binaries and documentation implies that the product is free for non-commercial use. Although the development phase is not over and many features are to be implemented yet the project is considered ready for public use and creating applications in various fields including development of events reconstruction software for small and moderate scale HEP experiments.

Sugar ingestion and dichotic listening: Increased perceptual capacity is more than motivation.

PubMed

Scheel, Matthew H; Ambrose, Aimee L

2014-01-01

Participants ingested a sugar drink or a sugar-free drink and then engaged in a pair of dichotic listening tasks. Tasks presented category labels then played a series of word pairs, one in the left ear and one in the right. Participants attempted to identify pairs containing a target category member. Target category words were homonyms. For example, arms appeared as a target in the "body parts" category. Nontargets that played along with targets were related to a category-appropriate version of the target (e.g., sleeves), a category-inappropriate version (e.g., weapons), or were unrelated to either version of the target (e.g., plant). Hence, an effect of nontarget type on number of targets missed was evidence that participants processed nontargets for meaning. In the divided attention task, participants monitored both ears. In the focused attention task, participants monitored the left ear. Half the participants in each group had the divided attention task before the focused attention task; the other half had the focused attention task before the divided attention task. We set task lengths to about 12 min so working on the first task would give sufficient time for metabolizing sugar from the drink before the start of the second task. Nontarget word type significantly affected targets missed in both tasks. Drink type affected performance in the divided attention task only after sufficient time for converting sugar into blood glucose. The result supports an energy model for the effect of sugar ingestion on perceptual tasks rather than a motivational model.

HST archive primer, version 4.1

NASA Technical Reports Server (NTRS)

Fruchter, A. (Editor); Baum, S. (Editor)

1994-01-01

This version of the HST Archive Primer provides the basic information a user needs to know to access the HST archive via StarView the new user interface to the archive. Using StarView, users can search for observations interest, find calibration reference files, and retrieve data from the archive. Both the terminal version of StarView and the X-windows version feature a name resolver which simplifies searches of the HST archive based on target name. In addition, the X-windows version of StarView allows preview of all public HST data; compressed versions of public images are displayed via SAOIMAGE, while spectra are plotted using the public plotting package, XMGR. Finally, the version of StarView described here features screens designed for observers preparing Cycle 5 HST proposals.

Matching of Developed Generic Competences of Graduates in Higher Education with Labour Market Needs

ERIC Educational Resources Information Center

Pukelis, Kestutis; Pileicikiene, Nora

2012-01-01

Higher education provides graduates with both monetary and non-monetary benefits. Globalization and technological developments foster utilitarian approach, therefore the transmission of competences that are relevant in labour market is an important target for higher education institutions. The paper presents findings of research on the match of…

Universal absolute quantification of biomolecules using element mass spectrometry and generic standards.

PubMed

Calderón-Celis, Francisco; Sanz-Medel, Alfredo; Encinar, Jorge Ruiz

2018-01-23

We present a novel and highly sensitive ICP-MS approach for absolute quantification of all important target biomolecule containing P, S, Se, As, Br, and/or I (e.g., proteins and phosphoproteins, metabolites, pesticides, drugs), under the same simple instrumental conditions and without requiring any specific and/or isotopically enriched standard.

New generic primer system targeting mucosal/genital and cutaneous human papillomaviruses leads to the characterization of HPV 115, a novel Beta-papillomavirus species 3

PubMed Central

Chouhy, Diego; Gorosito, Mario; Sánchez, Adriana; Serra, Esteban C; Bergero, Adriana; Bussy, Ramón Fernandez; Giri, Adriana A

2009-01-01

We explored the cutaneotropic HPV genetic diversity in 71 subjects from Argentina. New generic primers (CUT) targeting 88 mucosal/cutaneous HPV were designed and compared to FAP primers. Overall, 69 different HPV types/putative types were identified, being 17 of them novel putative types. Phylogenetic analysis of partial L1 sequences grouped 2 novel putative types in the Beta-PV, 14 in the Gamma-PV and 1 in the Mu-PV genera. CUT primers showed broader capacity than FAP primers in detecting different genera/species and novel putative types (p<0.01). Using overlapping PCR, the full-length genome of a Beta-PV putative type was amplified and cloned. The new virus, designated HPV 115, encodes 5 early genes and 2 late genes. Phylogenetic analysis indicated HPV 115 as the most divergent type within the genus Beta-PV species 3. This report is the first providing data on cutaneous HPVs circulating in South America and expands our knowledge of the Papillomaviridae family. PMID:19948351

A generic screening platform for inhibitors of virus induced cell fusion using cellular electrical impedance

PubMed Central

Watterson, Daniel; Robinson, Jodie; Chappell, Keith J.; Butler, Mark S.; Edwards, David J.; Fry, Scott R.; Bermingham, Imogen M.; Cooper, Matthew A.; Young, Paul R.

2016-01-01

Fusion of the viral envelope with host cell membranes is an essential step in the life cycle of all enveloped viruses. Despite such a clear target for antiviral drug development, few anti-fusion drugs have progressed to market. One significant hurdle is the absence of a generic, high-throughput, reproducible fusion assay. Here we report that real time, label-free measurement of cellular electrical impedance can quantify cell-cell fusion mediated by either individually expressed recombinant viral fusion proteins, or native virus infection. We validated this approach for all three classes of viral fusion and demonstrated utility in quantifying fusion inhibition using antibodies and small molecule inhibitors specific for dengue virus and respiratory syncytial virus. PMID:26976324

Pharmaceutical company influences on medication prescribing and their potential impact on quality use of medicines.

PubMed

Kyle, G J; Nissen, L M; Tett, S E

2008-10-01

Pharmaceuticals are big business, reporting strong market growth year after year. The 'gatekeepers' of this market are prescribers of medicines, who are the major target of pharmaceutical companies, utilizing direct and indirect influences. This paper draws on previous research investigating pharmaceutical company prescribing influences to develop a qualitative model demonstrating the synergism between commercial influences on prescribing. The generic model was used to explore a realistic but hypothetical scenario to ascertain the applicability of the model. A generic influence model was developed. The model was readily able to be adapted to reflect a realistic practice scenario. Prescriber awareness of the linkages between various seemingly separate marketing techniques could potentially improve medicines usage in an evidence-based practice paradigm.

A multiplex PCR-based method to identify strongylid parasite larvae recovered from ovine faecal cultures and/or pasture samples.

PubMed

Bisset, S A; Knight, J S; Bouchet, C L G

2014-02-24

A multiplex PCR-based method was developed to overcome the limitations of microscopic examination as a means of identifying individual infective larvae from the wide range of strongylid parasite species commonly encountered in sheep in mixed sheep-cattle grazing situations in New Zealand. The strategy employed targets unique species-specific sequence markers in the second internal transcribed spacer (ITS-2) region of ribosomal DNA of the nematodes and utilises individual larval lysates as reaction templates. The basic assay involves two sets of reactions designed to target the ten strongylid species most often encountered in ovine faecal cultures under New Zealand conditions (viz. Haemonchus contortus, Teladorsagia circumcincta, Trichostrongylus axei, Trichostrongylus colubriformis, Trichostrongylus vitrinus, Cooperia curticei, Cooperia oncophora, Nematodirus spathiger, Chabertia ovina, and Oesophagostomum venulosum). Five species-specific primers, together with a pair of "generic" (conserved) primers, are used in each of the reactions. Two products are generally amplified, one by the generic primer pair regardless of species (providing a positive PCR control) and the other (whose size is indicative of the species present) by the appropriate species-specific primer in combination with one or other of the generic primers. If necessary, any larvae not identified by these reactions can subsequently be tested using primers designed specifically to detect those species less frequently encountered in ovine faecal cultures (viz. Ostertagia ostertagi, Ostertagia leptospicularis, Cooperia punctata, Nematodirus filicollis, and Bunostomum trigonocephalum). Results of assays undertaken on >5500 nematode larvae cultured from lambs on 16 different farms distributed throughout New Zealand indicated that positive identifications were initially obtained for 92.8% of them, while a further 4.4% of reactions gave a generic but no visible specific product and 2.8% gave no discernible PCR products (indicative of insufficient or poor quality DNA template). Of the reactions which yielded only generic products, 91% gave positive identifications in an assay re-run, resulting in a failure rate of just ∼ 0.4% for reactions containing amplifiable template. Although the method was developed primarily to provide a reliable way to identify individual strongylid larvae for downstream molecular applications, it potentially has a variety of other research and practical applications which are not readily achievable at present using other methods. Copyright © 2013 Elsevier B.V. All rights reserved.

An Impact Evaluation of Two Versions of a Brief Intervention Targeting Alcohol Use and Physical Activity among Adolescents

ERIC Educational Resources Information Center

Mathews, Anna E.; Werch, Chudley (CHAD); Michniewicz, Mara; Bian, Hui

2007-01-01

The purpose of the study was to evaluate the immediate impact of two new versions of the Project SPORT program, a brief one-on-one tailored consult addressing alcohol use and physical activity for adolescents. One new version was a brief interactive CD-ROM (Study one) and a second was a brief small group consultation (Study two). In study one,…

A Japanese version of the Rosenberg Self-Esteem Scale: translation and equivalence assessment.

PubMed

Mimura, Chizu; Griffiths, Peter

2007-05-01

A Japanese version of the Rosenberg Self-Esteem Scale (RSES) was developed through the forward-backward translation procedure. Married couples consisting of a native English speaker and a native Japanese speaker acted as translators to enhance the representativeness of language in the target population. Multiple translations were produced, and a panel of reviewers identified problems in conceptual and semantic equivalence between the original scale and the translated version. The Japanese version was altered accordingly with reference to alternate Japanese forms from the original English to Japanese translations. The altered translation was again retranslated into English, and problematic differences were checked. This forward-backward process was repeated until satisfactory agreement had been attained. The RSES was administered to 222 native English speakers, and the developed Japanese version (RSES-J) was administered to 1320 native Japanese speakers. Factor analysis revealed nearly identical factor structure and structural coefficients of the items between two sets of data. Target rotation confirmed the factorial agreement of the two scales in different cultural groups. High Cronbach's alpha coefficients supported the reliability of test scores on both versions. The equivalence between the RSES and the RSES-J was supported in this study. It is suggested that the RSES and the RSES-J are potential tools for comparative cross-cultural studies.

Can increases in CHIP copayments reduce program expenditures on prescription drugs?

PubMed

Sen, Bisakha; Blackburn, Justin; Morrisey, Michael; Becker, David; Kilgore, Meredith; Caldwell, Cathy; Menachemi, Nir

2014-01-01

The primary aim is to explore whether prescription drug expenditures by enrollees changed in Alabama's CHIP program, ALL Kids, after copayment increases in fiscal year 2004. The subsidiary aim is to explore whether non-pharmaceutical expenditures also changed. Data on ALL Kids enrollees between 1999-2007, obtained from claims files and the state's administrative database. We used data on children who were enrolled between one and three years both before and after the changes to the copayment schedule, and estimate regression models with individual-level fixed effects to control for time-invariant heterogeneity at the child level. This allows an accurate estimate of how program expenditures change for the same individual following copayment changes. Primary outcomes of interest are expenditures for prescription drugs by class and brand-name and generic versions. We estimate models for the likelihood of any use of prescription drugs and expenditure level conditional on use. Following the copayment increase, the probability of any expenditure decline by 5.8%, brand name drugs by 6.9%, generic drugs by 7.4%. Conditional on any use, program expenditures decline by 7.9% for all drugs, by 9.6% for brand name drugs, and 6.2% for generic drugs. The largest declines are for antihistamine drugs; the least declines are for Central Nervous System agents. Declines are smaller and statistically weaker for children with chronic health conditions. Concurrent declines are also seen for non-pharmaceutical medical expenditures. Copayment increases appear to reduce program expenditures on prescription drugs per enrollee and may be a useful tool for controlling program costs.

Projecting future drug expenditures--2012.

PubMed

Hoffman, James M; Li, Edward; Doloresco, Fred; Matusiak, Linda; Hunkler, Robert J; Shah, Nilay D; Vermeulen, Lee C; Schumock, Glen T

2012-03-01

Factors likely to influence drug expenditures, drug expenditure trends in 2010 and 2011, and projected drug expenditures for 2012 are discussed. Data were analyzed to provide drug expenditure trends for total drug expenditures and the hospital and clinic sectors. Data were obtained from the IMS Health National Sales Perspectives database. From 2009 to 2010, total U.S. drug expenditures increased by 2.7%, with total spending rising from $299.2 billion to $307.5 billion. Drug expenditures in clinics grew by 6.0% from 2009 to 2010. Hospital drug expenditures increased at the moderate rate of 1.5% from 2009 to 2010; through the first nine months of 2011, hospital drug expenditures increased by only 0.3% compared with the same period in 2010. The dominant trend over the past several years is substantial moderation in expenditure growth for widely used drugs, primarily due to the ongoing introduction and wide use of generic versions of high-cost, frequently used medications. At the end of 2010, generic drugs accounted for 78% of all retail prescriptions dispensed. Another pattern is substantial increases in expenditures for specialized medications, particularly in the outpatient setting as growth in prescription drug expenditures for clinic-administered drugs consistently outpaces growth in total expenditures. Various factors are likely to influence drug expenditures in 2012, including drugs in development, the diffusion of new drugs, generic drugs, drug shortages, and biosimilars. For 2012, we project a 3-5% increase in total drug expenditures across all settings, a 5-7% increase in expenditures for clinic-administered drugs, and a 0-2% increase in hospital drug expenditures.

The PedsQL Multidimensional Fatigue Scale in young adults: feasibility, reliability and validity in a University student population.

PubMed

Varni, James W; Limbers, Christine A

2008-02-01

The PedsQL (Pediatric Quality of Life Inventory) is a modular instrument designed to measure health-related quality of life (HRQOL) and disease-specific symptoms in children and adolescents ages 2-18. The PedsQL Multidimensional Fatigue Scale was designed as a generic symptom-specific instrument to measure fatigue in pediatric patients ages 2-18. Since a sizeable number of pediatric patients prefer to remain with their pediatric providers after age 18, the objective of the present study was to determine the feasibility, reliability, and validity of the PedsQL Multidimensional Fatigue Scale in young adults. The 18-item PedsQL Multidimensional Fatigue Scale (General Fatigue, Sleep/Rest Fatigue, and Cognitive Fatigue domains), the PedsQL 4.0 Generic Core Scales Young Adult Version, and the SF-8 Health Survey were completed by 423 university students ages 18-25. The PedsQL Multidimensional Fatigue Scale evidenced minimal missing responses, achieved excellent reliability for the Total Scale Score (alpha = 0.90), distinguished between healthy young adults and young adults with chronic health conditions, was significantly correlated with the relevant PedsQL 4.0 Generic Core Scales and the SF-8 standardized scores, and demonstrated a factor-derived structure largely consistent with the a priori conceptual model. The results demonstrate the measurement properties of the PedsQL Multidimensional Fatigue Scale in a convenience sample of young adult university students. The findings suggest that the PedsQL Multidimensional Fatigue Scale may be utilized in the evaluation of fatigue for a broad age range.

Biosimilar therapeutics—what do we need to consider?

PubMed Central

Schellekens, Huub

2009-01-01

Patents for the first generation of approved biopharmaceuticals have either expired or are about to expire. Thus the market is opening for generic versions, referred to as ‘biosimilars’ (European Union) or ‘follow-on protein products’ (United States). Healthcare professionals need to understand the critical issues surrounding the use of biosimilars to make informed treatment decisions. The complex high-molecular-weight three-dimensional structures of biopharmaceuticals, their heterogeneity and dependence on production in living cells makes them different from classical chemical drugs. Current analytical methods cannot characterize these complex molecules sufficiently to confirm structural equivalence with reference molecules. Verification of the similarity of biosimilars to innovator biopharmaceuticals remains a key challenge. Furthermore, a critical safety issue, the immunogenicity of biopharmaceuticals, has been highlighted in recent years, confirming a need for comprehensive immunogenicity testing prior to approval and extended post-marketing surveillance. Biosimilars present a new set of challenges for regulatory authorities when compared with conventional generics. While the demonstration of a pharmacokinetic similarity is sufficient for conventional, small-molecule generic agents, a number of issues will make the approval of biosimilars more complicated. Documents recently published by the European Medicines Agency (EMEA) outlining requirements for the market approval of biosimilars provide much-needed guidance. The EMEA has approved a number of biosimilar products in a scientifically rigorous and balanced process. Outstanding issues include the interchangeability of biosimilars and innovator products, the possible need for unique naming to differentiate the various biopharmaceutical products, and more comprehensive labelling for biosimilars to include relevant clinical data. PMID:19461855

A generic readout system for astrophysical detectors

NASA Astrophysics Data System (ADS)

Doumayrou, E.; Lortholary, M.

2012-09-01

We have developed a generic digital platform to fulfill the needs for the development of new detectors in astrophysics, which is used in lab, for ground-based telescopes instruments and also in prototype versions for space instruments development. This system is based on hardware FPGA electronic board (called MISE) together with software on a PC computer (called BEAR). The MISE board generates the fast clocking which reads the detectors thanks to a programmable digital sequencer and performs data acquisition, buffering of digitalized pixels outputs and interfaces with others boards. The data are then sent to the PC via a SpaceWire or Usb link. The BEAR software sets the MISE board up, makes data acquisition and enables the visualization, processing and the storage of data in line. These software tools are made of C++ and Labview (NI) on a Linux OS. MISE and BEAR make a generic acquisition architecture, on which dedicated analog boards are plugged, so that to accommodate with detectors specificity: number of pixels, the readout channels and frequency, analog bias and clock interfaces. We have used this concept to build a camera for the P-ARTEMIS project including a 256 pixels sub-millimeter bolometer detector at 10Kpixel/s (SPIE 7741-12 (2010)). For the EUCLID project, a lab camera is now working for the test of CCDs 4Mpixels at 4*200Kpixel/s. Another is working for the testing of new near infrared detectors (NIR LFSA for the ESA TRP program) 110Kpixels at 2*100Kpixels/s. Other projects are in progress for the space missions PLATO and SPICA.

A hybrid wavelet de-noising and Rank-Set Pair Analysis approach for forecasting hydro-meteorological time series.

PubMed

Wang, Dong; Borthwick, Alistair G; He, Handan; Wang, Yuankun; Zhu, Jieyu; Lu, Yuan; Xu, Pengcheng; Zeng, Xiankui; Wu, Jichun; Wang, Lachun; Zou, Xinqing; Liu, Jiufu; Zou, Ying; He, Ruimin

2018-01-01

Accurate, fast forecasting of hydro-meteorological time series is presently a major challenge in drought and flood mitigation. This paper proposes a hybrid approach, wavelet de-noising (WD) and Rank-Set Pair Analysis (RSPA), that takes full advantage of a combination of the two approaches to improve forecasts of hydro-meteorological time series. WD allows decomposition and reconstruction of a time series by the wavelet transform, and hence separation of the noise from the original series. RSPA, a more reliable and efficient version of Set Pair Analysis, is integrated with WD to form the hybrid WD-RSPA approach. Two types of hydro-meteorological data sets with different characteristics and different levels of human influences at some representative stations are used to illustrate the WD-RSPA approach. The approach is also compared to three other generic methods: the conventional Auto Regressive Integrated Moving Average (ARIMA) method, Artificial Neural Networks (ANNs) (BP-error Back Propagation, MLP-Multilayer Perceptron and RBF-Radial Basis Function), and RSPA alone. Nine error metrics are used to evaluate the model performance. Compared to three other generic methods, the results generated by WD-REPA model presented invariably smaller error measures which means the forecasting capability of the WD-REPA model is better than other models. The results show that WD-RSPA is accurate, feasible, and effective. In particular, WD-RSPA is found to be the best among the various generic methods compared in this paper, even when the extreme events are included within a time series. Copyright © 2017 Elsevier Inc. All rights reserved.

Kepler Science Operations Center Pipeline Framework

NASA Technical Reports Server (NTRS)

Klaus, Todd C.; McCauliff, Sean; Cote, Miles T.; Girouard, Forrest R.; Wohler, Bill; Allen, Christopher; Middour, Christopher; Caldwell, Douglas A.; Jenkins, Jon M.

2010-01-01

The Kepler mission is designed to continuously monitor up to 170,000 stars at a 30 minute cadence for 3.5 years searching for Earth-size planets. The data are processed at the Science Operations Center (SOC) at NASA Ames Research Center. Because of the large volume of data and the memory and CPU-intensive nature of the analysis, significant computing hardware is required. We have developed generic pipeline framework software that is used to distribute and synchronize the processing across a cluster of CPUs and to manage the resulting products. The framework is written in Java and is therefore platform-independent, and scales from a single, standalone workstation (for development and research on small data sets) to a full cluster of homogeneous or heterogeneous hardware with minimal configuration changes. A plug-in architecture provides customized control of the unit of work without the need to modify the framework itself. Distributed transaction services provide for atomic storage of pipeline products for a unit of work across a relational database and the custom Kepler DB. Generic parameter management and data accountability services are provided to record the parameter values, software versions, and other meta-data used for each pipeline execution. A graphical console allows for the configuration, execution, and monitoring of pipelines. An alert and metrics subsystem is used to monitor the health and performance of the pipeline. The framework was developed for the Kepler project based on Kepler requirements, but the framework itself is generic and could be used for a variety of applications where these features are needed.

Reliability and validity of the Chinese version of the Pediatric Quality Of Life InventoryTM (PedsQLTM) 3.0 neuromuscular module in children with Duchenne muscular dystrophy.

PubMed

Hu, Jun; Jiang, Li; Hong, Siqi; Cheng, Li; Kong, Min; Ye, Yuanzhen

2013-03-15

The Pediatric Quality of Life Inventory(TM) (PedsQL(TM)) is a widely used instrument to measure pediatric health-related quality of life (HRQOL) in children aged 2 to 18 years. The current study aimed to evaluate the reliability and validity of the Chinese version of the PedsQL(TM) 3.0 Neuromuscular Module in children with Duchenne muscular dystrophy (DMD). The PedsQL(TM) 3.0 Neuromuscular Module was translated into Chinese following PedsQL(TM) Measurement Model Translation Methodology. The Chinese version scale was administered to 56 children with DMD and their parents, and the psychometric properties were evaluated. The missing value percentages for each item of the Chinese version scale ranged from 0.00% to 0.54%. Internal consistency reliability approached or exceeded the minimum reliability standard of α = 0.7 (child α = 0.81, parent α = 0.86). Test-retest reliability was satisfactory, with intraclass correlation coefficients (ICCs) of 0.66 for children and 0.88 for parents (P < 0.01). Correlation coefficients between iteims and their hypothesized subscales were higher than those with other subscales (P < 0.05). The subscale of "About My/My Child's Neuromuscular Disease" significantly related to mobility and stair climbing status (Child t = 2.21, Parent t = 2.83, P < 0.05). The inter-correlations among the Chinese version of the PedsQL(TM) 3.0 Neuromuscular Module and the PedsQL(TM) 4.0 Generic Core Scales had medium to large effect sizes (P < 0.05). The child self-report scores were in moderate agreement with the parent proxy-report scores (ICC = 0.51, P < 0.05). The Chinese version of the PedsQLTM 3.0 Neuromuscular Module has acceptable psychometric properties. It is a reliable measure of disease-specific HRQOL in Chinese children with DMD.

Generic Entry, Reformulations, and Promotion of SSRIs

PubMed Central

Donohue, Julie M.; Koss, Catherine; Berndt, Ernst R.; Frank, Richard G.

2009-01-01

Background Previous research has shown that a manufacturer’s promotional strategy for a brand-name drug is typically affected by generic entry. However, little is known about how newer strategies to extend patent life, including product reformulation introduction or obtaining approval to market for additional clinical indications, influence promotion. Objective To examine the relationship between promotional expenditures, generic entry, reformulation entry, and new indication approval. Study Design/Setting We used quarterly data on national product-level promotional spending (including expenditures for physician detailing and direct-to-consumer advertising (DTCA), and the retail value of free samples distributed in physician offices) for selective serotonin reuptake inhibitors (SSRIs) over the period 1997 through 2004. We estimated econometric models of detailing, DTCA, and total quarterly promotional expenditures as a function of the timing of generic entry, entry of new product formulations, and Food and Drug Administration (FDA) approval for new clinical indications for existing medications in the SSRI class. Main Outcome Measure Expenditures by pharmaceutical manufacturers for promotion of antidepressant medications. Results Over the period 1997–2004, there was considerable variation in the composition of promotional expenditures across the SSRIs. Promotional expenditures for the original brand molecule decreased dramatically when a reformulation of the molecule was introduced. Promotional spending (both total and detailing alone) for a specific molecule was generally lower after generic entry than before, although the effect of generic entry on promotional spending appears to be closely linked with the choice of product reformulation strategy pursued by the manufacturer. Detailing expenditures for Paxil were increased after the manufacturer received FDA approval to market the drug for generalized anxiety disorder (GAD), while the likelihood of DTCA outlays for the drug was not changed. In contrast, FDA approval to market Paxil and Zoloft for social anxiety disorder (SAD) did not affect the manufacturers’ detailing expenditures but did result in a greater likelihood of DTCA outlays. Conclusion The introduction of new product formulations appears to be a common strategy for attempting to extend market exclusivity for medications facing impending generic entry. Manufacturers that introduced a reformulation before generic entry shifted most promotion dollars from the original brand to the reformulation long before generic entry, and in some cases manufacturers appeared to target a particular promotion type for a given indication. Given the significant impact pharmaceutical promotion has on demand for prescription drugs, these findings have important implications for prescription drug spending and public health. PMID:18563951

Selective CXCR4+ Cancer Cell Targeting and Potent Antineoplastic Effect by a Nanostructured Version of Recombinant Ricin.

PubMed

Díaz, Raquel; Pallarès, Victor; Cano-Garrido, Olivia; Serna, Naroa; Sánchez-García, Laura; Falgàs, Aïda; Pesarrodona, Mireia; Unzueta, Ugutz; Sánchez-Chardi, Alejandro; Sánchez, Julieta M; Casanova, Isolda; Vázquez, Esther; Mangues, Ramón; Villaverde, Antonio

2018-05-29

Under the unmet need of efficient tumor-targeting drugs for oncology, a recombinant version of the plant toxin ricin (the modular protein T22-mRTA-H6) is engineered to self-assemble as protein-only, CXCR4-targeted nanoparticles. The soluble version of the construct self-organizes as regular 11 nm planar entities that are highly cytotoxic in cultured CXCR4 + cancer cells upon short time exposure, with a determined IC50 in the nanomolar order of magnitude. The chemical inhibition of CXCR4 binding sites in exposed cells results in a dramatic reduction of the cytotoxic potency, proving the receptor-dependent mechanism of cytotoxicity. The insoluble version of T22-mRTA-H6 is, contrarily, moderately active, indicating that free, nanostructured protein is the optimal drug form. In animal models of acute myeloid leukemia, T22-mRTA-H6 nanoparticles show an impressive and highly selective therapeutic effect, dramatically reducing the leukemia cells affectation of clinically relevant organs. Functionalized T22-mRTA-H6 nanoparticles are then promising prototypes of chemically homogeneous, highly potent antitumor nanostructured toxins for precise oncotherapies based on self-mediated intracellular drug delivery. © 2018 WILEY-VCH Verlag GmbH & Co. KGaA, Weinheim.

Modal parameter identification of a compression-loaded CFRP stiffened plate and correlation with its buckling behaviour

NASA Astrophysics Data System (ADS)

Chaves-Vargas, M.; Dafnis, A.; Reimerdes, H.-G.; Schröder, K.-U.

2015-10-01

In order to study the dynamic response and the buckling behaviour of several load-carrying structural components of civil aircraft when subjected to transient load scenarios such as gusts or a landing impact, a generic mid-size aircraft is defined within the European research project DAEDALOS. From this aircraft, several sections or panels in different regions such as wing, vertical tailplane and fuselage are defined. The stiffened carbon-fibre-reinforced plastic (CFRP) plate investigated within the present work represents a simplified version of the wing panel selected from the generic aircraft. As part of the current work, the buckling behaviour and the modal properties of the stiffened plate under the effect of a static in-plane compression load are studied. This is accomplished by means of a test series including quasi-static buckling tests and an experimental modal analysis (EMA). One of the key objectives pursued is the correlation of the modal properties to the buckling behaviour by studying the relationship between the natural frequencies of the stiffened plate and its corresponding buckling load. The experimental work is verified by a finite element analysis.

Identification of minimal parameters for optimal suppression of chaos in dissipative driven systems.

PubMed

Martínez, Pedro J; Euzzor, Stefano; Gallas, Jason A C; Meucci, Riccardo; Chacón, Ricardo

2017-12-21

Taming chaos arising from dissipative non-autonomous nonlinear systems by applying additional harmonic excitations is a reliable and widely used procedure nowadays. But the suppressory effectiveness of generic non-harmonic periodic excitations continues to be a significant challenge both to our theoretical understanding and in practical applications. Here we show how the effectiveness of generic suppressory excitations is optimally enhanced when the impulse transmitted by them (time integral over two consecutive zeros) is judiciously controlled in a not obvious way. Specifically, the effective amplitude of the suppressory excitation is minimal when the impulse transmitted is maximum. Also, by lowering the impulse transmitted one obtains larger regularization areas in the initial phase difference-amplitude control plane, the price to be paid being the requirement of larger amplitudes. These two remarkable features, which constitute our definition of optimum control, are demonstrated experimentally by means of an analog version of a paradigmatic model, and confirmed numerically by simulations of such a damped driven system including the presence of noise. Our theoretical analysis shows that the controlling effect of varying the impulse is due to a subsequent variation of the energy transmitted by the suppressory excitation.

Discontinuous non-equilibrium phase transition in a threshold Schloegl model for autocatalysis: Generic two-phase coexistence and metastability

DOE PAGES

Wang, Chi -Jen; Liu, Da -Jiang; Evans, James W.

2015-04-28

Threshold versions of Schloegl’s model on a lattice, which involve autocatalytic creation and spontaneous annihilation of particles, can provide a simple prototype for discontinuous non-equilibrium phase transitions. These models are equivalent to so-called threshold contact processes. A discontinuous transition between populated and vacuum states can occur selecting a threshold of N ≥ 2 for the minimum number, N, of neighboring particles enabling autocatalytic creation at an empty site. Fundamental open questions remain given the lack of a thermodynamic framework for analysis. For a square lattice with N = 2, we show that phase coexistence occurs not at a unique valuemore » but for a finite range of particle annihilation rate (the natural control parameter). This generic two-phase coexistence also persists when perturbing the model to allow spontaneous particle creation. Such behavior contrasts both the Gibbs phase rule for thermodynamic systems and also previous analysis for this model. We find metastability near the transition corresponding to a non-zero effective line tension, also contrasting previously suggested critical behavior. As a result, mean-field type analysis, extended to treat spatially heterogeneous states, further elucidates model behavior.« less

Discontinuous non-equilibrium phase transition in a threshold Schloegl model for autocatalysis: Generic two-phase coexistence and metastability

NASA Astrophysics Data System (ADS)

Wang, Chi-Jen; Liu, Da-Jiang; Evans, James W.

2015-04-01

Threshold versions of Schloegl's model on a lattice, which involve autocatalytic creation and spontaneous annihilation of particles, can provide a simple prototype for discontinuous non-equilibrium phase transitions. These models are equivalent to so-called threshold contact processes. A discontinuous transition between populated and vacuum states can occur selecting a threshold of N ≥ 2 for the minimum number, N, of neighboring particles enabling autocatalytic creation at an empty site. Fundamental open questions remain given the lack of a thermodynamic framework for analysis. For a square lattice with N = 2, we show that phase coexistence occurs not at a unique value but for a finite range of particle annihilation rate (the natural control parameter). This generic two-phase coexistence also persists when perturbing the model to allow spontaneous particle creation. Such behavior contrasts both the Gibbs phase rule for thermodynamic systems and also previous analysis for this model. We find metastability near the transition corresponding to a non-zero effective line tension, also contrasting previously suggested critical behavior. Mean-field type analysis, extended to treat spatially heterogeneous states, further elucidates model behavior.

Ada Compiler Validation Summary Report: Certificate Number 880318W1. 09042, International Business Machines Corporation, IBM Development System for the Ada Language, Version 2.1.0, IBM 4381 under MVS/XA, Host and Target

DTIC Science & Technology

1988-03-28

International Business Machines Corporation IBM Development System for the Ada Language, Version 2.1.0 IBM 4381 under MVS/XA, host and target Completion...Joint Program Office, AJPO 20. ABSTRACT (Continue on reverse side if necessary and identify by block number) International Business Machines Corporation...in the compiler listed in this declaration. I declare that International Business Machines Corporation is the owner of record of the object code of

Best Practices for Artifact Versioning in Service-Oriented Systems

DTIC Science & Technology

2012-01-01

and endpoint [OASIS 2004]. But as Peltz and Anagol- Subbarao warn, “[I]t can be appealing to version down to the very lowest levels in accordance...Schemes There are multiple sources for typical naming schemes in SOA environments: • Anagol- Subbarao and Peltz provide service naming schemes, including...service versioning. 3. Extensions must not use the targetNamespace value. Peltz and Anagol- Subbarao provide additional guidance on how to implement

Leicester Cough Questionnaire: translation to Portuguese and cross-cultural adaptation for use in Brazil*

PubMed Central

Felisbino, Manuela Brisot; Steidle, Leila John Marques; Gonçalves-Tavares, Michelle; Pizzichini, Marcia Margaret Menezes; Pizzichini, Emilio

2014-01-01

Objective: To translate the Leicester Cough Questionnaire (LCQ) to Portuguese and adapt it for use in Brazil. Methods: Cross-cultural adaptation of a quality of life questionnaire requires a translated version that is conceptually equivalent to the original version and culturally acceptable in the target country. The protocol used consisted of the translation of the LCQ to Portuguese by three Brazilian translators who were fluent in English and its back-translation to English by another translator who was a native speaker of English and fluent in Portuguese. The back-translated version was evaluated by one of the authors of the original questionnaire in order to verify its equivalence. Later in the process, a provisional Portuguese-language version was thoroughly reviewed by an expert committee. In 10 patients with chronic cough, cognitive debriefing was carried out in order to test the understandability, clarity, and acceptability of the translated questionnaire in the target population. On that basis, the final Portuguese-language version of the LCQ was produced and approved by the committee. Results: Few items were questioned by the source author and revised by the committee of experts. During the cognitive debriefing phase, the Portuguese-language version of the LCQ proved to be well accepted and understood by all of the respondents, which demonstrates the robustness of the process of translation and cross-cultural adaptation. Conclusions: The final version of the LCQ adapted for use in Brazil was found to be easy to understand and easily applied. PMID:25029643

Genre-Pragmatic Strategies in English Letter-of-Application Writing of Jordanian Arabic--English Bilinguals

ERIC Educational Resources Information Center

Al-Ali, Mohammed N.

2006-01-01

This study reports an investigation of the genre components and pragmatic strategies of letters of applications written by Jordanian Arabic--English bilinguals. Specifically it is set up to trace how far novice non-native speakers of English are able to utilise the generic components and politeness strategies of the target language that strongly…

One Size Does Not Fit All: Effective Community-Engaged Outreach Practices with Immigrant Communities

ERIC Educational Resources Information Center

Smalkoski, Kari; Axtell, Sara; Zimmer, Jeanne; Noor, Ibrahim

2016-01-01

Generic outreach approaches are commonly used to target as many individuals as possible in a cultural community to achieve a greater response rate. However, this one-size-fits-all tactic is rarely effective. Community-engaged outreach practices have been successful with immigrant communities in Minnesota's Twin Cities. When practitioners,…

Intelligence, Surveillance, and Reconnaissance Fusion for Coalition Operations

DTIC Science & Technology

2008-07-01

classification of the targets of interest. The MMI features extracted in this manner have two properties that provide a sound justification for...are generalizations of well- known feature extraction methods such as Principal Components Analysis (PCA) and Independent Component Analysis (ICA...augment (without degrading performance) a large class of generic fusion processes. Ontologies Classifications Feature extraction Feature analysis

The Generic Short Patient Experiences Questionnaire (GS-PEQ): identification of core items from a survey in Norway

PubMed Central

2011-01-01

Background Questionnaires are commonly used to collect patient, or user, experiences with health care encounters; however, their adaption to specific target groups limits comparison between groups. We present the construction of a generic questionnaire (maximum of ten questions) for user evaluation across a range of health care services. Methods Based on previous testing of six group-specific questionnaires, we first constructed a generic questionnaire with 23 items related to user experiences. All questions included a "not applicable" response option, as well as a follow-up question about the item's importance. Nine user groups from one health trust were surveyed. Seven groups received questionnaires by mail and two by personal distribution. Selection of core questions was based on three criteria: applicability (proportion "not applicable"), importance (mean scores on follow-up questions), and comprehensiveness (content coverage, maximum two items per dimension). Results 1324 questionnaires were returned providing subsample sizes ranging from 52 to 323. Ten questions were excluded because the proportion of "not applicable" responses exceeded 20% in at least one user group. The number of remaining items was reduced to ten by applying the two other criteria. The final short questionnaire included items on outcome (2), clinician services (2), user involvement (2), incorrect treatment (1), information (1), organisation (1), and accessibility (1). Conclusion The Generic Short Patient Experiences Questionnaire (GS-PEQ) is a short, generic set of questions on user experiences with specialist health care that covers important topics for a range of groups. It can be used alone or with other instruments in quality assessment or in research. The psychometric properties and the relevance of the GS-PEQ in other health care settings and countries need further evaluation. PMID:21510871

Author Correction: Targeted inhibition of STAT/TET1 axis as a therapeutic strategy for acute myeloid leukemia.

PubMed

Jiang, Xi; Hu, Chao; Ferchen, Kyle; Nie, Ji; Cui, Xiaolong; Chen, Chih-Hong; Cheng, Liting; Zuo, Zhixiang; Seibel, William; He, Chunjiang; Tang, Yixuan; Skibbe, Jennifer R; Wunderlich, Mark; Reinhold, William C; Dong, Lei; Shen, Chao; Arnovitz, Stephen; Ulrich, Bryan; Lu, Jiuwei; Weng, Hengyou; Su, Rui; Huang, Huilin; Wang, Yungui; Li, Chenying; Qin, Xi; Mulloy, James C; Zheng, Yi; Diao, Jiajie; Jin, Jie; Li, Chong; Liu, Paul P; He, Chuan; Chen, Yuan; Chen, Jianjun

2018-02-09

The original version of this Article contained an error in the spelling of the author James C. Mulloy, which was incorrectly given as James Mulloy. This has now been corrected in both the PDF and HTML versions of the Article.

Fluid dynamic modeling and numerical simulation of low-density hypersonic flow

NASA Astrophysics Data System (ADS)

Cheng, H. K.; Wong, Eric Y.

1988-06-01

The concept of a viscous shock-layer and several related versions of continuum theories/methods are examined for their adequacy as a viable framework to study flow physics and aerothermodynamics of relevance to sustained hypersonic flights. Considering the flat plate at angle of attack, or the wedge, as a generic example for the major aerodynamic component of a hypersonic vehicle, the relative importance of the molecular-transport effects behind the shock (in the form of the 'shock slip') and the wall-slip effects are studied. In the flow regime where the shock-transition-zone thickness remains small compared to the shock radius of curvature, a quasi-one-dimensional shock structure under the Burnett/thirteen-moment approximation, as well as particulate/collisional models, can be consistently developed. The fully viscous version of the shock-layer model is shown to provide the crucial boundary condition downstream the shock in this case. The gas-kinetic basis of the continuum description for the flow behind the bow shock, and certain features affecting the non-equilibrium flow chemistry, are also discussed.

Top-down and bottom-up analysis of commercial enoxaparins.

PubMed

Liu, Xinyue; St Ange, Kalib; Lin, Lei; Zhang, Fuming; Chi, Lianli; Linhardt, Robert J

2017-01-13

A strategy for the comprehensive analysis of low molecular weight (LMW) heparins is described that relies on using an integrated top-down and bottom-up approach. Liquid chromatography-mass spectrometry, an essential component of this approach, is rapid, robust, and amenable to automated processing and interpretation. Nuclear magnetic resonance spectroscopy provides complementary top-down information on the chirality of the uronic acid residues comprising a low molecular weight heparin. Using our integrated approach four different low molecular weight heparins prepared from porcine heparin through chemical β-eliminative cleavage were comprehensively analyzed. Lovenox™ and Clexane™, the innovator versions of enoxaparin marketed in the US and Europe, respectively, and two generic enoxaparins, from Sandoz and Teva, were analyzed. The results which were supported by analysis of variation (ANOVA), while showing remarkable similarities between different versions of the product and good lot-to-lot consistency of each product, also detects subtle differences that may result from differences in their manufacturing processes or differences in the source (or parent) porcine heparin from which each product is prepared. Copyright © 2016 Elsevier B.V. All rights reserved.

Advanced CLIPS capabilities

NASA Technical Reports Server (NTRS)

Riley, Gary

1991-01-01

The C Language Integrated Production System (CLIPS) is a forward chaining rule based language developed by NASA. CLIPS was designed specifically to provide high portability, low cost, and easy integration with external systems. The current release of CLIPS, version 4.3, is being used by over 2500 users throughout the public and private community. The primary addition to the next release of CLIPS, version 5.0, will be the CLIPS Object Oriented Language (COOL). The major capabilities of COOL are: class definition with multiple inheritance and no restrictions on the number, types, or cardinality of slots; message passing which allows procedural code bundled with an object to be executed; and query functions which allow groups of instances to be examined and manipulated. In addition to COOL, numerous other enhancements were added to CLIPS including: generic functions (which allow different pieces of procedural code to be executed depending upon the types or classes of the arguments); integer and double precision data type support; multiple conflict resolution strategies; global variables; logical dependencies; type checking on facts; full ANSI compiler support; and incremental reset for rules.

Fluid dynamic modeling and numerical simulation of low-density hypersonic flow

NASA Technical Reports Server (NTRS)

Cheng, H. K.; Wong, Eric Y.

1988-01-01

The concept of a viscous shock-layer and several related versions of continuum theories/methods are examined for their adequacy as a viable framework to study flow physics and aerothermodynamics of relevance to sustained hypersonic flights. Considering the flat plate at angle of attack, or the wedge, as a generic example for the major aerodynamic component of a hypersonic vehicle, the relative importance of the molecular-transport effects behind the shock (in the form of the 'shock slip') and the wall-slip effects are studied. In the flow regime where the shock-transition-zone thickness remains small compared to the shock radius of curvature, a quasi-one-dimensional shock structure under the Burnett/thirteen-moment approximation, as well as particulate/collisional models, can be consistently developed. The fully viscous version of the shock-layer model is shown to provide the crucial boundary condition downstream the shock in this case. The gas-kinetic basis of the continuum description for the flow behind the bow shock, and certain features affecting the non-equilibrium flow chemistry, are also discussed.

Distribution of a Generic Mission Planning and Scheduling Toolkit for Astronomical Spacecraft

NASA Technical Reports Server (NTRS)

Kleiner, Steven C.

1996-01-01

Work is progressing as outlined in the proposal for this contract. A working planning and scheduling system has been documented and packaged and made available to the WIRE Small Explorer group at JPL, the FUSE group at JHU, the NASA/GSFC Laboratory for Astronomy and Solar Physics and the Advanced Planning and Scheduling Branch at STScI. The package is running successfully on the WIRE computer system. It is expected that the WIRE will reuse significant portions of the SWAS code in its system. This scheduling system itself was tested successfully against the spacecraft hardware in December 1995. A fully automatic scheduling module has been developed and is being added to the toolkit. In order to maximize reuse, the code is being reorganized during the current build into object-oriented class libraries. A paper describing the toolkit has been written and is included in the software distribution. We have experienced interference between the export and production versions of the toolkit. We will be requesting permission to reprogram funds in order to purchase a standalone PC onto which to offload the export version.

Rapid evaluation of high-performance systems

NASA Astrophysics Data System (ADS)

Forbes, G. W.; Ruoff, J.

2017-11-01

System assessment for design often involves averages, such as rms wavefront error, that are estimated by ray tracing through a sample of points within the pupil. Novel general-purpose sampling and weighting schemes are presented and it is also shown that optical design can benefit from tailored versions of these schemes. It turns out that the type of Gaussian quadrature that has long been recognized for efficiency in this domain requires about 40-50% more ray tracing to attain comparable accuracy to generic versions of the new schemes. Even greater efficiency gains can be won, however, by tailoring such sampling schemes to the optical context where azimuthal variation in the wavefront is generally weaker than the radial variation. These new schemes are special cases of what is known in the mathematical world as cubature. Our initial results also led to the consideration of simpler sampling configurations that approximate the newfound cubature schemes. We report on the practical application of a selection of such schemes and make observations that aid in the discovery of novel cubature schemes relevant to optical design of systems with circular pupils.

Spontaneous PT-Symmetry Breaking for Systems of Noncommutative Euclidean Lie Algebraic Type

NASA Astrophysics Data System (ADS)

Dey, Sanjib; Fring, Andreas; Mathanaranjan, Thilagarajah

2015-11-01

We propose a noncommutative version of the Euclidean Lie algebra E 2. Several types of non-Hermitian Hamiltonian systems expressed in terms of generic combinations of the generators of this algebra are investigated. Using the breakdown of the explicitly constructed Dyson maps as a criterium, we identify the domains in the parameter space in which the Hamiltonians have real energy spectra and determine the exceptional points signifying the crossover into the different types of spontaneously broken PT-symmetric regions with pairs of complex conjugate eigenvalues. We find exceptional points which remain invariant under the deformation as well as exceptional points becoming dependent on the deformation parameter of the algebra.

PropeR revisited.

PubMed

van der Linden, Helma; Talmon, Jan; Tange, Huibert; Grimson, Jane; Hasman, Arie

2005-03-01

The PropeR EHR system (PropeRWeb) is a multidisciplinary electronic health record (EHR) system for multidisciplinary use in extramural patient care for stroke patients. The system is built using existing open source components and is based on open standards. It is implemented as a web application using servlets and Java Server Pages (JSP's) with a CORBA connection to the database servers, which are based on the OMG HDTF specifications. PropeRWeb is a generic system which can be readily customized for use in a variety of clinical domains. The system proved to be stable and flexible, although some aspects (a.o. user friendliness) could be improved. These improvements are currently under development in a second version.

Users guide: The LaRC human-operator-simulator-based pilot model

NASA Technical Reports Server (NTRS)

Bogart, E. H.; Waller, M. C.

1985-01-01

A Human Operator Simulator (HOS) based pilot model has been developed for use at NASA LaRC for analysis of flight management problems. The model is currently configured to simulate piloted flight of an advanced transport airplane. The generic HOS operator and machine model was originally developed under U.S. Navy sponsorship by Analytics, Inc. and through a contract with LaRC was configured to represent a pilot flying a transport airplane. A version of the HOS program runs in batch mode on LaRC's (60-bit-word) central computer system. This document provides a guide for using the program and describes in some detail the assortment of files used during its operation.

Author Correction: Targeted gadofullerene for sensitive magnetic resonance imaging and risk-stratification of breast cancer.

PubMed

Han, Zheng; Wu, Xiaohui; Roelle, Sarah; Chen, Chuheng; Schiemann, William P; Lu, Zheng-Rong

2018-01-08

In the original version of this Article, the penultimate sentence of the Abstract incorrectly read 'The dose of the contrast agent for effective molecular MRI is only slightly lower than that of ZD2-Cy5.5 (0.5 µmol kg -1 ) in fluorescence imaging.' The correct version states 'higher' in place of 'lower'. This error has been corrected in both the PDF and HTML versions of the Article.

Ada (Trade Name) Compiler Validation Summary Report: Harris Corporation Harris Ada Compiler, Version 1.3 Harris HCX-7.

DTIC Science & Technology

1987-06-03

Harris Corp. Harris Ada Compiler, Ver.1.3 Harris HCX-7 6. PERFORMING ORG. REPORT NUMBER 7 AUTH R(s 8. CONTRACT OR GRANT...VALIDATION SUMMARY REPORT : Harris Corporation Harris Ada Compiler, Version 1.3 Harris HCX-7 Completion of On-Site Testing: 3 June 1987 & .. . 0 Prepared...Place NTIS form here + .. . .. . .. .. Ada’ Compiler Validation Summary Report : Compiler Name: Harris Ada Compiler, Version 1.3 Host: Target: Harris

Semantic interoperability--HL7 Version 3 compared to advanced architecture standards.

PubMed

Blobel, B G M E; Engel, K; Pharow, P

2006-01-01

To meet the challenge for high quality and efficient care, highly specialized and distributed healthcare establishments have to communicate and co-operate in a semantically interoperable way. Information and communication technology must be open, flexible, scalable, knowledge-based and service-oriented as well as secure and safe. For enabling semantic interoperability, a unified process for defining and implementing the architecture, i.e. structure and functions of the cooperating systems' components, as well as the approach for knowledge representation, i.e. the used information and its interpretation, algorithms, etc. have to be defined in a harmonized way. Deploying the Generic Component Model, systems and their components, underlying concepts and applied constraints must be formally modeled, strictly separating platform-independent from platform-specific models. As HL7 Version 3 claims to represent the most successful standard for semantic interoperability, HL7 has been analyzed regarding the requirements for model-driven, service-oriented design of semantic interoperable information systems, thereby moving from a communication to an architecture paradigm. The approach is compared with advanced architectural approaches for information systems such as OMG's CORBA 3 or EHR systems such as GEHR/openEHR and CEN EN 13606 Electronic Health Record Communication. HL7 Version 3 is maturing towards an architectural approach for semantic interoperability. Despite current differences, there is a close collaboration between the teams involved guaranteeing a convergence between competing approaches.

AEOSS design guide for system analysis on Advanced Earth-Orbital Spacecraft Systems

NASA Technical Reports Server (NTRS)

Lee, Hwa-Ping

1990-01-01

Advanced Earth Orbital Spacecraft System (AEOSS) enables users to project the requried power, weight, and cost for a generic earth-orbital spacecraft system. These variables are calculated on the component and subsystem levels, and then the system level. The included six subsystems are electric power, thermal control, structure, auxillary propulsion, attitude control, and communication, command, and data handling. The costs are computed using statistically determined models that were derived from the flown spacecraft in the past and were categorized into classes according to their functions and structural complexity. Selected design and performance analyses for essential components and subsystems are also provided. AEOSS has the feature permitting a user to enter known values of these parameters, totally and partially, at all levels. All information is of vital importance to project managers of subsystems or a spacecraft system. AEOSS is a specially tailored software coded from the relational database program of the Acius; 4th Dimension with a Macintosh version. Because of the licensing agreement, two versions of the AEOSS documents were prepared. This version AEOSS Design Guide, is for users to exploit the full capacity of the 4th Dimension. It is for a user who wants to alter or expand the program structures, the program statements, and the program procedures. The user has to possess a 4th Dimension first.

Ada Compiler Validation Summary Report: Certificate Number: 880318W1. 09043 International Business Machines Corporation IBM Development System for the Ada Language, Version 2.1.0 IBM 4381 under VM/HPO, Host IBM 4381 under MVS/XA, Target

DTIC Science & Technology

1988-03-28

International Business Machines Corporation IBM Development System for the Ada Language, Version 2.1.0 IBM 4381 under VM/HPO, host IBM 4381 under MVS/XA, target...Program Office, AJPO 20. ABSTRACT (Continue on reverse side if necessary and identify by block number) International Business Machines Corporation, IBM...Standard ANSI/MIL-STD-1815A in the compiler listed in this declaration. I declare that International Business Machines Corporation is the owner of record

Satisfaction of patients hospitalised in psychiatric hospitals: a randomised comparison of two psychiatric-specific and one generic satisfaction questionnaires

PubMed Central

Peytremann-Bridevaux, Isabelle; Scherer, Frédy; Peer, Laurence; Cathieni, Federico; Bonsack, Charles; Cléopas, Agatta; Kolly, Véronique; Perneger, Thomas V; Burnand, Bernard

2006-01-01

Background While there is interest in measuring the satisfaction of patients discharged from psychiatric hospitals, it might be important to determine whether surveys of psychiatric patients should employ generic or psychiatry-specific instruments. The aim of this study was to compare two psychiatric-specific and one generic questionnaires assessing patients' satisfaction after a hospitalisation in a psychiatric hospital. Methods We randomised adult patients discharged from two Swiss psychiatric university hospitals between April and September 2004, to receive one of three instruments: the Saphora-Psy questionnaire, the Perceptions of Care survey questionnaire or the Picker Institute questionnaire for acute care hospitals. In addition to the comparison of response rates, completion time, mean number of missing items and mean ceiling effect, we targeted our comparison on patients and asked them to answer ten evaluation questions about the questionnaire they had just completed. Results 728 out of 1550 eligible patients (47%) participated in the study. Across questionnaires, response rates were similar (Saphora-Psy: 48.5%, Perceptions of Care: 49.9%, Picker: 43.4%; P = 0.08), average completion time was lowest for the Perceptions of Care questionnaire (minutes: Saphora-Psy: 17.7, Perceptions of Care: 13.7, Picker: 17.5; P = 0.005), the Saphora-Psy questionnaire had the largest mean proportion of missing responses (Saphora-Psy: 7.1%, Perceptions of Care: 2.8%, Picker: 4.0%; P < 0.001) and the Perceptions of Care questionnaire showed the highest ceiling effect (Saphora-Psy: 17.1%, Perceptions of Care: 41.9%, Picker: 36.3%; P < 0.001). There were no differences in the patients' evaluation of the questionnaires. Conclusion Despite differences in the intended target population, content, lay-out and length of questionnaires, none appeared to be obviously better based on our comparison. All three presented advantages and drawbacks and could be used for the satisfaction evaluation of psychiatric inpatients. However, if comparison across medical services or hospitals is desired, using a generic questionnaire might be advantageous. PMID:16938136

Measuring Individual Differences in Generic Beliefs in Conspiracy Theories Across Cultures: Conspiracy Mentality Questionnaire

PubMed Central

Bruder, Martin; Haffke, Peter; Neave, Nick; Nouripanah, Nina; Imhoff, Roland

2013-01-01

Conspiracy theories are ubiquitous when it comes to explaining political events and societal phenomena. Individuals differ not only in the degree to which they believe in specific conspiracy theories, but also in their general susceptibility to explanations based on such theories, that is, their conspiracy mentality. We present the Conspiracy Mentality Questionnaire (CMQ), an instrument designed to efficiently assess differences in the generic tendency to engage in conspiracist ideation within and across cultures. The CMQ is available in English, German, and Turkish. In four studies, we examined the CMQ’s factorial structure, reliability, measurement equivalence across cultures, and its convergent, discriminant, and predictive validity. Analyses based on a cross-cultural sample (Study 1a; N = 7,766) supported the conceptualization of conspiracy mentality as a one-dimensional construct across the three language versions of the CMQ that is stable across time (Study 1b; N = 141). Multi-group confirmatory factor analysis demonstrated cross-cultural measurement equivalence of the CMQ items. The instrument could therefore be used to examine differences in conspiracy mentality between European, North American, and Middle Eastern cultures. In Studies 2–4 (total N = 476), we report (re-)analyses of three datasets demonstrating the validity of the CMQ in student and working population samples in the UK and Germany. First, attesting to its convergent validity, the CMQ was highly correlated with another measure of generic conspiracy belief. Second, the CMQ showed patterns of meaningful associations with personality measures (e.g., Big Five dimensions, schizotypy), other generalized political attitudes (e.g., social dominance orientation and right-wing authoritarianism), and further individual differences (e.g., paranormal belief, lack of socio-political control). Finally, the CMQ predicted beliefs in specific conspiracy theories over and above other individual difference measures. PMID:23641227

Generic calculation of two-body partial decay widths at the full one-loop level

NASA Astrophysics Data System (ADS)

Goodsell, Mark D.; Liebler, Stefan; Staub, Florian

2017-11-01

We describe a fully generic implementation of two-body partial decay widths at the full one-loop level in the SARAH and SPheno framework compatible with most supported models. It incorporates fermionic decays to a fermion and a scalar or a gauge boson as well as scalar decays into two fermions, two gauge bosons, two scalars or a scalar and a gauge boson. We present the relevant generic expressions for virtual and real corrections. Whereas wave-function corrections are determined from on-shell conditions, the parameters of the underlying model are by default renormalised in a \\overline{ {DR}} (or \\overline{ {MS}}) scheme. However, the user can also define model-specific counter-terms. As an example we discuss the renormalisation of the electric charge in the Thomson limit for top-quark decays in the standard model. One-loop-induced decays are also supported. The framework additionally allows the addition of mass and mixing corrections induced at higher orders for the involved external states. We explain our procedure to cancel infrared divergences for such cases, which is achieved through an infrared counter-term taking into account corrected Goldstone boson vertices. We compare our results for sfermion, gluino and Higgs decays in the minimal supersymmetric standard model (MSSM) against the public codes SFOLD, FVSFOLD and HFOLD and explain observed differences. Radiatively induced gluino and neutralino decays are compared against the original implementation in SPheno in the MSSM. We exactly reproduce the results of the code CNNDecays for decays of neutralinos and charginos in R-parity violating models. The new version SARAH 4.11.0 by default includes the calculation of two-body decay widths at the full one-loop level. Current limitations for certain model classes are described.

An ICU Preanesthesia Evaluation Form Reduces Missing Preoperative Key Information.

PubMed

Chuy, Katherine; Yan, Zhe; Fleisher, Lee; Liu, Renyu

2012-09-28

A comprehensive preoperative evaluation is critical for providing anesthetic care for patients from the intensive care unit (ICU). There has been no preoperative evaluation form specific for ICU patients that allows for a rapid and focused evaluation by anesthesia providers, including junior residents. In this study, a specific preoperative form was designed for ICU patients and evaluated to allow residents to perform the most relevant and important preoperative evaluations efficiently. The following steps were utilized for developing the preoperative evaluation form: 1) designed a new preoperative form specific for ICU patients; 2) had the form reviewed by attending physicians and residents, followed by multiple revisions; 3) conducted test releases and revisions; 4) released the final version and conducted a survey; 5) compared data collection from new ICU form with that from a previously used generic form. Each piece of information on the forms was assigned a score, and the score for the total missing information was determined. The score for each form was presented as mean ± standard deviation (SD), and compared by unpaired t test. A P value < 0.05 was considered statistically significant. Of 52 anesthesiologists (19 attending physicians, 33 residents) responding to the survey, 90% preferred the final new form; and 56% thought the new form would reduce perioperative risk for ICU patients. Forty percent were unsure whether the form would reduce perioperative risk. Over a three month period, we randomly collected 32 generic forms and 25 new forms. The average score for missing data was 23 ± 10 for the generic form and 8 ± 4 for the new form (P = 2.58E-11). A preoperative evaluation form designed specifically for ICU patients is well accepted by anesthesia providers and helped to reduce missing key preoperative information. Such an approach is important for perioperative patient safety.

The CURB65 pneumonia severity score outperforms generic sepsis and early warning scores in predicting mortality in community‐acquired pneumonia

PubMed Central

Barlow, Gavin; Nathwani, Dilip; Davey, Peter

2007-01-01

Background The performance of CURB65 in predicting mortality in community‐acquired pneumonia (CAP) has been tested in two large observational studies. However, it has not been tested against generic sepsis and early warning scores, which are increasingly being advocated for identification of high‐risk patients in acute medical wards. Method A retrospective analysis was performed of data prospectively collected for a CAP quality improvement study. The ability to stratify mortality and performance characteristics (sensitivity, specificity, positive predictive value, negative predictive value and area under the receiver operating curve) were calculated for stratifications of CURB65, CRB65, the systemic inflammatory response syndrome (SIRS) criteria and the standardised early warning score (SEWS). Results 419 patients were included in the main analysis with a median age of 74 years (men = 47%). CURB65 and CRB65 stratified mortality in a more clinically useful way and had more favourable operating characteristics than SIRS or SEWS; for example, mortality in low‐risk patients was 2% when defined by CURB65, but 9% when defined by SEWS and 11–17% when defined by variations of the SIRS criteria. The sensitivity, specificity, positive predictive value and negative predictive value of CURB65 was 71%, 69%, 35% and 91%, respectively, compared with 62%, 73%, 35% and 89% for the best performing version of SIRS and 52%, 67%, 27% and 86% for SEWS. CURB65 had the greatest area under the receiver operating curve (0.78 v 0.73 for CRB65, 0.68 for SIRS and 0.64 for SEWS). Conclusions CURB65 should not be supplanted by SIRS or SEWS for initial prognostic assessment in CAP. Further research to identify better generic prognostic tools is required. PMID:16928720

Dispensing behaviour of pharmacies in prescription drug markets.

PubMed

Guhl, Dennis; Stargardt, Tom; Schneider, Udo; Fischer, Katharina E

2016-02-01

We aim to investigate pharmacies' dispensing behaviour under the existing dispensing regulations in Germany. Using administrative data, we performed a cross-sectional retrospective study to analyse whether the competitive environment and pharmacy characteristics, i.e., organisation, lead to dispensing choices aimed at by third-party payers. We specified generalised linear models with the share of imported pharmaceuticals, generic share, and share of preferred brands as dependent variables. The final dataset contained 49,260,902 prescriptions from 16,797 pharmacies. The average share of imported pharmaceuticals across the pharmacies was 18.4% (standard deviation (SD) 8.8), the average generic share was 92.8% (SD 2.1), and compliance with preferred brands was 81.3% (SD 5.9). Pharmacies with little competition used fewer imported pharmaceuticals (p<0.001), generics (p<0.001) and preferred brands (p<0.001); less organised pharmacies yielded similar results. The difference in outcomes between pharmacies in the first and 4th quartiles of the pharmacy organisation variable is 17.4% vs. 17.0% for share of imported pharmaceuticals, 92.8% vs. 92.7% for generic share and 81.9% vs. 81.1% for compliance with preferred brands. We show that pharmacies' dispensing choices meet the aims of payers at high levels. However, dispensing behaviour varies between pharmacies. Increasing competition among pharmacies and targeting pharmacies with high shares of bill auditing seem viable options to improving dispensing behaviour as defined by payers. Copyright © 2016 Elsevier Ireland Ltd. All rights reserved.

Ecological Risk Assessment Framework for Low-Altitude Overflights by Fixed-Wing and Rotary-Wing Military Aircraft

DOE Office of Scientific and Technical Information (OSTI.GOV)

Efroymson, R.A.

2001-01-12

This is a companion report to the risk assessment framework proposed by Suter et al. (1998): ''A Framework for Assessment of Risks of Military Training and Testing to Natural Resources,'' hereafter referred to as the ''generic framework.'' The generic framework is an ecological risk assessment methodology for use in environmental assessments on Department of Defense (DoD) installations. In the generic framework, the ecological risk assessment framework of the US Environmental Protection Agency (EPA 1998) is modified for use in the context of (1) multiple and diverse stressors and activities at a military installation and (2) risks resulting from causal chains,more » e.g., effects on habitat that indirectly impact wildlife. Both modifications are important if the EPA framework is to be used on military installations. In order for the generic risk assessment framework to be useful to DoD environmental staff and contractors, the framework must be applied to specific training and testing activities. Three activity-specific ecological risk assessment frameworks have been written (1) to aid environmental staff in conducting risk assessments that involve these activities and (2) to guide staff in the development of analogous frameworks for other DoD activities. The three activities are: (1) low-altitude overflights by fixed-wing and rotary-wing aircraft (this volume), (2) firing at targets on land, and (3) ocean explosions. The activities were selected as priority training and testing activities by the advisory committee for this project.« less

The CARMEN software as a service infrastructure.

PubMed

Weeks, Michael; Jessop, Mark; Fletcher, Martyn; Hodge, Victoria; Jackson, Tom; Austin, Jim

2013-01-28

The CARMEN platform allows neuroscientists to share data, metadata, services and workflows, and to execute these services and workflows remotely via a Web portal. This paper describes how we implemented a service-based infrastructure into the CARMEN Virtual Laboratory. A Software as a Service framework was developed to allow generic new and legacy code to be deployed as services on a heterogeneous execution framework. Users can submit analysis code typically written in Matlab, Python, C/C++ and R as non-interactive standalone command-line applications and wrap them as services in a form suitable for deployment on the platform. The CARMEN Service Builder tool enables neuroscientists to quickly wrap their analysis software for deployment to the CARMEN platform, as a service without knowledge of the service framework or the CARMEN system. A metadata schema describes each service in terms of both system and user requirements. The search functionality allows services to be quickly discovered from the many services available. Within the platform, services may be combined into more complicated analyses using the workflow tool. CARMEN and the service infrastructure are targeted towards the neuroscience community; however, it is a generic platform, and can be targeted towards any discipline.

DNA-encoded libraries - an efficient small molecule discovery technology for the biomedical sciences.

PubMed

Kunig, Verena; Potowski, Marco; Gohla, Anne; Brunschweiger, Andreas

2018-06-27

DNA-encoded compound libraries are a highly attractive technology for the discovery of small molecule protein ligands. These compound collections consist of small molecules covalently connected to individual DNA sequences carrying readable information about the compound structure. DNA-tagging allows for efficient synthesis, handling and interrogation of vast numbers of chemically synthesized, drug-like compounds. They are screened on proteins by an efficient, generic assay based on Darwinian principles of selection. To date, selection of DNA-encoded libraries allowed for the identification of numerous bioactive compounds. Some of these compounds uncovered hitherto unknown allosteric binding sites on target proteins; several compounds proved their value as chemical biology probes unraveling complex biology; and the first examples of clinical candidates that trace their ancestry to a DNA-encoded library were reported. Thus, DNA-encoded libraries proved their value for the biomedical sciences as a generic technology for the identification of bioactive drug-like molecules numerous times. However, large scale experiments showed that even the selection of billions of compounds failed to deliver bioactive compounds for the majority of proteins in an unbiased panel of target proteins. This raises the question of compound library design.

Can the Fatigue Severity Scale 7-item version be used across different patient populations as a generic fatigue measure - a comparative study using a Rasch model approach

PubMed Central

2014-01-01

Background Fatigue is a disabling symptom associated with reduced quality of life in various populations living with chronic illnesses. The transfer of knowledge about fatigue from one group to another is crucial in both research and healthcare. Outcomes should be validly and reliably comparable between groups and should not be unduly influenced by diagnostic variations. The present study evaluates whether the Fatigue Severity Scale 7-item version (FSS-7) demonstrates similar item hierarchy across people with multiple sclerosis, stroke or HIV/AIDS to ensure valid comparisons between groups, and provide further evidence of internal scale validity. Methods A secondary comparative analysis was performed using data from three different studies of three different chronic illnesses: multiple sclerosis, stroke and HIV/AIDS. Each of these studies had previously concluded that the FSS-7 has better psychometric properties than the original FSS for measuring fatigue interference. Data from 224 people with multiple sclerosis, 104 people with stroke and 316 people with HIV/AIDS were examined. Item response theory and a Rasch model were chosen to analyze the similarity of the FSS-7 item hierarchy across the three diagnostic groups Results Cross-sample differences were found for items #3, #5, #6 and #9 for two of the three samples, which raise questions about item validity across groups. However, disease-specific and disease-generic Rasch measures were similar across samples, indicating that individual fatigue interference measures in these three chronic illnesses might still be reliably comparable using the FSS-7. Conclusions Some items performed differently between the three samples but did not bias person measures, thereby indicating that fatigue interference in these illnesses might still be reliably compared using FSS-7 scores. However, caution is warranted when comparing fatigue raw sum scores directly across diagnostic groups using the FSS-7. Further studies of the scale are needed in other types of chronic illnesses. PMID:24559076

A generic biogeochemical module for Earth system models: Next Generation BioGeoChemical Module (NGBGC), version 1.0

NASA Astrophysics Data System (ADS)

Fang, Y.; Huang, M.; Liu, C.; Li, H.; Leung, L. R.

2013-11-01

Physical and biogeochemical processes regulate soil carbon dynamics and CO2 flux to and from the atmosphere, influencing global climate changes. Integration of these processes into Earth system models (e.g., community land models (CLMs)), however, currently faces three major challenges: (1) extensive efforts are required to modify modeling structures and to rewrite computer programs to incorporate new or updated processes as new knowledge is being generated, (2) computational cost is prohibitively expensive to simulate biogeochemical processes in land models due to large variations in the rates of biogeochemical processes, and (3) various mathematical representations of biogeochemical processes exist to incorporate different aspects of fundamental mechanisms, but systematic evaluation of the different mathematical representations is difficult, if not impossible. To address these challenges, we propose a new computational framework to easily incorporate physical and biogeochemical processes into land models. The new framework consists of a new biogeochemical module, Next Generation BioGeoChemical Module (NGBGC), version 1.0, with a generic algorithm and reaction database so that new and updated processes can be incorporated into land models without the need to manually set up the ordinary differential equations to be solved numerically. The reaction database consists of processes of nutrient flow through the terrestrial ecosystems in plants, litter, and soil. This framework facilitates effective comparison studies of biogeochemical cycles in an ecosystem using different conceptual models under the same land modeling framework. The approach was first implemented in CLM and benchmarked against simulations from the original CLM-CN code. A case study was then provided to demonstrate the advantages of using the new approach to incorporate a phosphorus cycle into CLM. To our knowledge, the phosphorus-incorporated CLM is a new model that can be used to simulate phosphorus limitation on the productivity of terrestrial ecosystems. The method presented here could in theory be applied to simulate biogeochemical cycles in other Earth system models.

xPerm: fast index canonicalization for tensor computer algebra

NASA Astrophysics Data System (ADS)

Martín-García, José M.

2008-10-01

We present a very fast implementation of the Butler-Portugal algorithm for index canonicalization with respect to permutation symmetries. It is called xPerm, and has been written as a combination of a Mathematica package and a C subroutine. The latter performs the most demanding parts of the computations and can be linked from any other program or computer algebra system. We demonstrate with tests and timings the effectively polynomial performance of the Butler-Portugal algorithm with respect to the number of indices, though we also show a case in which it is exponential. Our implementation handles generic tensorial expressions with several dozen indices in hundredths of a second, or one hundred indices in a few seconds, clearly outperforming all other current canonicalizers. The code has been already under intensive testing for several years and has been essential in recent investigations in large-scale tensor computer algebra. Program summaryProgram title: xPerm Catalogue identifier: AEBH_v1_0 Program summary URL:http://cpc.cs.qub.ac.uk/summaries/AEBH_v1_0.html Program obtainable from: CPC Program Library, Queen's University, Belfast, N. Ireland Licensing provisions: Standard CPC licence, http://cpc.cs.qub.ac.uk/licence/licence.html No. of lines in distributed program, including test data, etc.: 93 582 No. of bytes in distributed program, including test data, etc.: 1 537 832 Distribution format: tar.gz Programming language: C and Mathematica (version 5.0 or higher) Computer: Any computer running C and Mathematica (version 5.0 or higher) Operating system: Linux, Unix, Windows XP, MacOS RAM:: 20 Mbyte Word size: 64 or 32 bits Classification: 1.5, 5 Nature of problem: Canonicalization of indexed expressions with respect to permutation symmetries. Solution method: The Butler-Portugal algorithm. Restrictions: Multiterm symmetries are not considered. Running time: A few seconds with generic expressions of up to 100 indices. The xPermDoc.nb notebook supplied with the distribution takes approximately one and a half hours to execute in full.

Development and validation of the Italian version of the Mobile Application Rating Scale and its generalisability to apps targeting primary prevention.

PubMed

Domnich, Alexander; Arata, Lucia; Amicizia, Daniela; Signori, Alessio; Patrick, Bernard; Stoyanov, Stoyan; Hides, Leanne; Gasparini, Roberto; Panatto, Donatella

2016-07-07

A growing body of literature affirms the usefulness of mobile technologies, including mobile applications (apps), in the primary prevention field. The quality of health apps, which today number in the thousands, is a crucial parameter, as it may affect health-related decision-making and outcomes among app end-users. The mobile application rating scale (MARS) has recently been developed to evaluate the quality of such apps, and has shown good psychometric properties. Since there is no standardised tool for assessing the apps available in Italian app stores, the present study developed and validated an Italian version of MARS in apps targeting primary prevention. The original 23-item version of the MARS assesses mobile app quality in four objective quality dimensions (engagement, functionality, aesthetics, information) and one subjective dimension. Validation of this tool involved several steps; the universalist approach to achieving equivalence was adopted. Following two backward translations, a reconciled Italian version of MARS was produced and compared with the original scale. On the basis of sample size estimation, 48 apps from three major app stores were downloaded; the first 5 were used for piloting, while the remaining 43 were used in the main study in order to assess the psychometric properties of the scale. The apps were assessed by two raters, each working independently. The psychometric properties of the final version of the scale was assessed including the inter-rater reliability, internal consistency, convergent, divergent and concurrent validities. The intralingual equivalence of the Italian version of the MARS was confirmed by the authors of the original scale. A total of 43 apps targeting primary prevention were tested. The MARS displayed acceptable psychometric properties. The MARS total score showed an excellent level of both inter-rater agreement (intra-class correlation coefficient of .96) and internal consistency (Cronbach's α of .90 and .91 for the two raters, respectively). Other types of validity, including convergent, divergent, discriminative, known-groups and scalability, were also established. The Italian version of MARS is a valid and reliable tool for assessing the health-related primary prevention apps available in Italian app stores.

[Effect of concreteness of target words on verbal working memory: an evaluation using Japanese version of reading span test].

PubMed

Kondo, H; Osaka, N

2000-04-01

Effects of concreteness and representation mode (kanji/hiragana) of target words on working memory during reading was tested using Japanese version of reading span test (RST), developed by Osaka and Osaka (1994). Concreteness and familiarity of target words and difficulty of sentences were carefully controlled. The words with high concreteness resulted in significantly higher RST scores, which suggests the high efficiency of working memory in processing these words. The results suggest that high concrete noun-words associated with visual clues consume less working memory capacity during reading. The effect of representation mode is different between subjects with high-RST and low-RST scores. Characteristic of the high concrete words that may be responsible for the effectiveness of processing are discussed.

Comparison of response rates and cost-effectiveness for a community-based survey: postal, internet and telephone modes with generic or personalised recruitment approaches

PubMed Central

2012-01-01

Background Epidemiological research often requires collection of data from a representative sample of the community or recruitment of specific groups through broad community approaches. The population coverage of traditional survey methods such as mail-outs to residential addresses, and telephone contact via public directories or random-digit-dialing is declining and survey response rates are falling. There is a need to explore new sampling frames and consider multiple response modes including those offered by changes in telecommunications and internet technology. Methods We evaluated response rates and cost-effectiveness for three modes of survey administration (postal invitation/postal survey, postal invitation/internet survey and postal invitation/telephone survey) and two styles of contact approach (personalised and generic) in a community survey of greywater use. Potential respondents were contacted only once, with no follow up of non-responders. Results The telephone survey produced the highest adjusted response rate (30.2%), followed by the personalised postal survey (10.5%), generic postal survey (7.5%) and then the internet survey (4.7% for the personalised approach and 2.2% for the generic approach). There were some differences in household characteristics and greywater use rates between respondents to different survey modes, and between respondents to personalised and generic approaches. These may be attributable to the differing levels of motivations needed for a response, and varying levels of interest in the survey topic among greywater users and non-users. The generic postal survey had the lowest costs per valid survey received (Australian $22.93), followed by the personalised postal survey ($24.75). Conclusions Our findings suggest that postal surveys currently remain the most economic option for population-based studies, with similar costs for personalised and generic approaches. Internet surveys may be effective for specialised groups where email lists are available for initial contact, but barriers other than household internet access still exist for community-based surveys. Given the increasing recruitment challenges facing community-based studies, there is an imperative to gather contemporary comparative data on different survey modes and recruitment approaches in order to determine their strengths, limitations and costs. Researchers also need to document and report on the potential biases in the target and respondent populations and how this may affect the data collected. PMID:22938205

Employing machine learning for reliable miRNA target identification in plants

PubMed Central

2011-01-01

Background miRNAs are ~21 nucleotide long small noncoding RNA molecules, formed endogenously in most of the eukaryotes, which mainly control their target genes post transcriptionally by interacting and silencing them. While a lot of tools has been developed for animal miRNA target system, plant miRNA target identification system has witnessed limited development. Most of them have been centered around exact complementarity match. Very few of them considered other factors like multiple target sites and role of flanking regions. Result In the present work, a Support Vector Regression (SVR) approach has been implemented for plant miRNA target identification, utilizing position specific dinucleotide density variation information around the target sites, to yield highly reliable result. It has been named as p-TAREF (plant-Target Refiner). Performance comparison for p-TAREF was done with other prediction tools for plants with utmost rigor and where p-TAREF was found better performing in several aspects. Further, p-TAREF was run over the experimentally validated miRNA targets from species like Arabidopsis, Medicago, Rice and Tomato, and detected them accurately, suggesting gross usability of p-TAREF for plant species. Using p-TAREF, target identification was done for the complete Rice transcriptome, supported by expression and degradome based data. miR156 was found as an important component of the Rice regulatory system, where control of genes associated with growth and transcription looked predominant. The entire methodology has been implemented in a multi-threaded parallel architecture in Java, to enable fast processing for web-server version as well as standalone version. This also makes it to run even on a simple desktop computer in concurrent mode. It also provides a facility to gather experimental support for predictions made, through on the spot expression data analysis, in its web-server version. Conclusion A machine learning multivariate feature tool has been implemented in parallel and locally installable form, for plant miRNA target identification. The performance was assessed and compared through comprehensive testing and benchmarking, suggesting a reliable performance and gross usability for transcriptome wide plant miRNA target identification. PMID:22206472

Employing machine learning for reliable miRNA target identification in plants.

PubMed

Jha, Ashwani; Shankar, Ravi

2011-12-29

miRNAs are ~21 nucleotide long small noncoding RNA molecules, formed endogenously in most of the eukaryotes, which mainly control their target genes post transcriptionally by interacting and silencing them. While a lot of tools has been developed for animal miRNA target system, plant miRNA target identification system has witnessed limited development. Most of them have been centered around exact complementarity match. Very few of them considered other factors like multiple target sites and role of flanking regions. In the present work, a Support Vector Regression (SVR) approach has been implemented for plant miRNA target identification, utilizing position specific dinucleotide density variation information around the target sites, to yield highly reliable result. It has been named as p-TAREF (plant-Target Refiner). Performance comparison for p-TAREF was done with other prediction tools for plants with utmost rigor and where p-TAREF was found better performing in several aspects. Further, p-TAREF was run over the experimentally validated miRNA targets from species like Arabidopsis, Medicago, Rice and Tomato, and detected them accurately, suggesting gross usability of p-TAREF for plant species. Using p-TAREF, target identification was done for the complete Rice transcriptome, supported by expression and degradome based data. miR156 was found as an important component of the Rice regulatory system, where control of genes associated with growth and transcription looked predominant. The entire methodology has been implemented in a multi-threaded parallel architecture in Java, to enable fast processing for web-server version as well as standalone version. This also makes it to run even on a simple desktop computer in concurrent mode. It also provides a facility to gather experimental support for predictions made, through on the spot expression data analysis, in its web-server version. A machine learning multivariate feature tool has been implemented in parallel and locally installable form, for plant miRNA target identification. The performance was assessed and compared through comprehensive testing and benchmarking, suggesting a reliable performance and gross usability for transcriptome wide plant miRNA target identification.

Integrated Targeting and Guidance for Powered Planetary Descent

NASA Astrophysics Data System (ADS)

Azimov, Dilmurat M.; Bishop, Robert H.

2018-02-01

This paper presents an on-board guidance and targeting design that enables explicit state and thrust vector control and on-board targeting for planetary descent and landing. These capabilities are developed utilizing a new closed-form solution for the constant thrust arc of the braking phase of the powered descent trajectory. The key elements of proven targeting and guidance architectures, including braking and approach phase quartics, are employed. It is demonstrated that implementation of the proposed solution avoids numerical simulation iterations, thereby facilitating on-board execution of targeting procedures during the descent. It is shown that the shape of the braking phase constant thrust arc is highly dependent on initial mass and propulsion system parameters. The analytic solution process is explicit in terms of targeting and guidance parameters, while remaining generic with respect to planetary body and descent trajectory design. These features increase the feasibility of extending the proposed integrated targeting and guidance design to future cargo and robotic landing missions.

Integrated Targeting and Guidance for Powered Planetary Descent

NASA Astrophysics Data System (ADS)

Azimov, Dilmurat M.; Bishop, Robert H.

2018-06-01

This paper presents an on-board guidance and targeting design that enables explicit state and thrust vector control and on-board targeting for planetary descent and landing. These capabilities are developed utilizing a new closed-form solution for the constant thrust arc of the braking phase of the powered descent trajectory. The key elements of proven targeting and guidance architectures, including braking and approach phase quartics, are employed. It is demonstrated that implementation of the proposed solution avoids numerical simulation iterations, thereby facilitating on-board execution of targeting procedures during the descent. It is shown that the shape of the braking phase constant thrust arc is highly dependent on initial mass and propulsion system parameters. The analytic solution process is explicit in terms of targeting and guidance parameters, while remaining generic with respect to planetary body and descent trajectory design. These features increase the feasibility of extending the proposed integrated targeting and guidance design to future cargo and robotic landing missions.

Health-Related Quality of Life in Persons With Ostomies Managed in an Outpatient Care Setting.

PubMed

Santos, Vera Lucia Conceição de Gouveia; Augusto, Fabiana da Silva; Gomboski, Gustavo

2016-01-01

We examined health-related quality of life (HRQOL) in persons with ostomies receiving outpatient care. We also analyzed relationships among HRQOL, demographic, and pertinent clinical factors. We used a descriptive, exploratory, cross-sectional study design to collect and analyze data. Data in this article are a secondary analysis of data collected from a primary study, developed by Santos and Gomboski, on the adaptation and validation of the City of Hope-Quality of Life-Ostomy Questionnaire (COH-QOL-OQ) to the Portuguese language in Brazil. A convenience sample of 215 adults living with an ostomy was evaluated. Slightly more than half (51.6%) were men, 67.5% underwent colostomy surgery, and 59.1% underwent cancer-related ostomy surgery. Subjects received care in specialized health care units in 3 cities in the Brazilian state of Rio Grande do Sul. After approval by the Research Ethics Committee and permission from health care units, data were collected using 2 instruments: the World Health Organization Quality of Life-Short Version (WHOQOL-Bref) (generic HRQOL instrument) and the COH-QOL-OQ (disease specific HRQOL instrument). Data were analyzed using χ test and logistic regression (via a stepwise forward method). Patients were classified into 3 groups according to the means and standard deviations of the scores: low, moderate, and high quality of life (QOL). Ostomy patients had total scores of 69.6 ± 20.2 and 6.1 ± 1.4 for the WHOQOL-Bref and COH-QOL-OQ instruments, respectively. Patients with shorter times since their ostomy creation had worse scores on both the specific QOL (P = .006) and generic QOL (P = .019) instruments. Patients who did not practice religion (P = .027; odds ratio [OR] = 3.39) and those without a partner/spouse (P = .007; OR = 4.90) had increased probability of having worse scores on the WHOQOL-Bref (generic instrument). Persons living with ostomies were found to have scores indicating moderate HRQOL on a disease-specific and generic instrument. Shorter time since ostomy creation, lack of religious practice, and lack of a partner negatively influenced the HRQOL of these patients.

PharmMapper 2017 update: a web server for potential drug target identification with a comprehensive target pharmacophore database.

PubMed

Wang, Xia; Shen, Yihang; Wang, Shiwei; Li, Shiliang; Zhang, Weilin; Liu, Xiaofeng; Lai, Luhua; Pei, Jianfeng; Li, Honglin

2017-07-03

The PharmMapper online tool is a web server for potential drug target identification by reversed pharmacophore matching the query compound against an in-house pharmacophore model database. The original version of PharmMapper includes more than 7000 target pharmacophores derived from complex crystal structures with corresponding protein target annotations. In this article, we present a new version of the PharmMapper web server, of which the backend pharmacophore database is six times larger than the earlier one, with a total of 23 236 proteins covering 16 159 druggable pharmacophore models and 51 431 ligandable pharmacophore models. The expanded target data cover 450 indications and 4800 molecular functions compared to 110 indications and 349 molecular functions in our last update. In addition, the new web server is united with the statistically meaningful ranking of the identified drug targets, which is achieved through the use of standard scores. It also features an improved user interface. The proposed web server is freely available at http://lilab.ecust.edu.cn/pharmmapper/. © The Author(s) 2017. Published by Oxford University Press on behalf of Nucleic Acids Research.

Korean version of the functional assessment of cancer therapy (FACT)-vanderbilt cystectomy index (VCI): translation and linguistic.

PubMed

Kim, Myong; Lee, Hahn Ey; Kim, Sung Han; Cho, Sung Yong; Jeong, Seong Jin; Oh, Seung June; Cookson, Michael S; Ku, Ja Hyeon

2014-11-30

To develop a Korean version of the Functional Assessment of Cancer Therapy (FACT)-Vanderbilt Cystectomy Index (VCI) from the original English version, with subsequent linguistic validation in Korean patients who underwent radical cystectomy with urinary diversion. Translation and linguistic validation were carried out between January and May of 2013, which consisted of the following stages:(1) permission for translation;(2) forward translation;(3) reconciliation;(4) backward translation;(5) cognitive debriefing and(6) final proof-reading. During the forward translation phases,word as such as "bother","spend time", "support", "coping" and "concern" were adjusted to be more comprehensible to the target population. There conciled Korean version was accepted without certain objections because the original version and the backward translation were almost congruent except for minor differences in a subset of questions. The translation was tested using 5 Korean-speaking subjects. The subjects took an average of 8.2 minutes to complete the questionnaire, without difficulty and found the questionnaire clear and easy to understand. The panel discussed each of the issues raised by subjects and most terms were judged by the panel as to not require further changes because the overall comprehension levels were relatively high and because the translated terms were accurately rendered in the target languages. This report has demonstrated that despite translation difficulties, the linguistic validation of the FACT-VCI in the Korean language was successful. The next step is to assess the psychometric properties of the Korean version of FACT-VCI.

Cultural adaptation of the Test of Narrative Language (TNL) into Brazilian Portuguese.

PubMed

Rossi, Natalia Freitas; Lindau, Tâmara de Andrade; Gillam, Ronald Bradley; Giacheti, Célia Maria

To accomplish the translation and cultural adaptation of the Test of Narrative Language (TNL) into Brazilian Portuguese. The TNL is a formal instrument which assesses narrative comprehension and oral narration of children between the ages of 5-0 and 11-11 (years-months). The TNL translation and adaptation process had the following steps: (1) translation into the target language; (2) summary of the translated versions; (3) back-translation; (4) checking of the conceptual, semantics and cultural equivalence process and (5) pilot study (56 children within the test age range and from both genders). The adapted version maintained the same structure as the original version: number of tasks (both, three comprehension and oral narration), narrative formats (no picture, sequenced pictures and single picture) and scoring system. There were no adjustments to the pictures. The "McDonald's Story" was replaced by the "Snack Bar History" to meet the semantic and experiential equivalence of the target population. The other stories had semantic and grammatical adjustments. Statistically significant difference was found when comparing the raw score (comprehension, narration and total) of age groups from the adapted version. Adjustments were required to meet the equivalence between the original and the translated versions. The adapted version showed it has the potential to identify differences in oral narratives of children in the age range provided by the test. Measurement equivalence for validation and test standardization are in progress and will be able to supplement the study outcomes.

On the possibility of using polycrystalline material in the development of structure-based generic assays

DOE Office of Scientific and Technical Information (OSTI.GOV)

Allaire, Marc, E-mail: allaire@bnl.gov; Moiseeva, Natalia; Botez, Cristian E.

The correlation coefficients calculated between raw powder diffraction profiles can be used to identify ligand-bound/unbound states of lysozyme. The discovery of ligands that bind specifically to a targeted protein benefits from the development of generic assays for high-throughput screening of a library of chemicals. Protein powder diffraction (PPD) has been proposed as a potential method for use as a structure-based assay for high-throughput screening applications. Building on this effort, powder samples of bound/unbound states of soluble hen-egg white lysozyme precipitated with sodium chloride were compared. The correlation coefficients calculated between the raw diffraction profiles were consistent with the known bindingmore » properties of the ligands and suggested that the PPD approach can be used even prior to a full description using stereochemically restrained Rietveld refinement.« less

Targeted diphtheria toxin to treat BPDCN.

PubMed

FitzGerald, David J

2014-07-17

In this issue of Blood, Frankel et al describe a novel treatment of blastic plasmacytoid dendritic cell neoplasm (BPDCN) using an engineered version of diphtheria toxin that is targeted to malignant cells via a fusion with interleukin (IL)3 (see panel A).

A Survey of Recent MARTe Based Systems

NASA Astrophysics Data System (ADS)

Neto, André C.; Alves, Diogo; Boncagni, Luca; Carvalho, Pedro J.; Valcarcel, Daniel F.; Barbalace, Antonio; De Tommasi, Gianmaria; Fernandes, Horácio; Sartori, Filippo; Vitale, Enzo; Vitelli, Riccardo; Zabeo, Luca

2011-08-01

The Multithreaded Application Real-Time executor (MARTe) is a data driven framework environment for the development and deployment of real-time control algorithms. The main ideas which led to the present version of the framework were to standardize the development of real-time control systems, while providing a set of strictly bounded standard interfaces to the outside world and also accommodating a collection of facilities which promote the speed and ease of development, commissioning and deployment of such systems. At the core of every MARTe based application, is a set of independent inter-communicating software blocks, named Generic Application Modules (GAM), orchestrated by a real-time scheduler. The platform independence of its core library provides MARTe the necessary robustness and flexibility for conveniently testing applications in different environments including non-real-time operating systems. MARTe is already being used in several machines, each with its own peculiarities regarding hardware interfacing, supervisory control configuration, operating system and target control application. This paper presents and compares the most recent results of systems using MARTe: the JET Vertical Stabilization system, which uses the Real Time Application Interface (RTAI) operating system on Intel multi-core processors; the COMPASS plasma control system, driven by Linux RT also on Intel multi-core processors; ISTTOK real-time tomography equilibrium reconstruction which shares the same support configuration of COMPASS; JET error field correction coils based on VME, PowerPC and VxWorks; FTU LH reflected power system running on VME, Intel with RTAI.

Measuring health-related quality of life in Greek children: psychometric properties of the Greek version of the Pediatric Quality of Life Inventory(TM) 4.0 Generic Core Scales.

PubMed

Gkoltsiou, Konstantina; Dimitrakaki, Christine; Tzavara, Chara; Papaevangelou, Vassiliki; Varni, James W; Tountas, Yannis

2008-03-01

The aim of this study was to investigate the psychometric properties of the Greek version of the Pediatric Quality of Life Inventory(TM) 4.0 (PedsQL(TM) 4.0) as a population health outcome measure. After cultural linguistic validation, a cross-sectional study with the participation of 645 children (8-12 years old) and their primary caregivers was conducted in a nation-wide representative school-based sample to evaluate the psychometric properties of the measure. All PedsQL 4.0 scales showed satisfactory reliability, with Cronbach's alpha exceeding 0.70--except in self-reported Physical Functioning (alpha = 0.65). Test-retest stability intraclass correlation coefficients (ICCs) were above 0.60 in all subscales. No floor effects were detected in either the self-report or parent proxy versions. Ceiling effects ranged from 2.2% (self-report Total Score) to 31.1% (parent-report Social Functioning). Poor to moderate agreement between self report and proxy report was observed, especially for the younger age groups of children. Impact of gender, health status, and family affluence status were detected, as hypothesised from previous bibliography, with girls reporting lower health-related quality of life (HRQOL) than boys on the Emotional Functioning subscale, healthy children scoring significantly higher on all scales than those with chronic illnesses, and lower socioeconomic groups scoring significantly lower than higher socioeconomic groups. Factor analysis showed mainly comparable results with the original version. Present results support the reliability and validity of the PedsQL 4.0 Greek version. The instrument could be a valuable tool in HRQOL measurement in school health care settings and population-based studies in Greek-speaking children, though it should be stressed that when possible, the child should be considered the first informant of his/her HRQOL.

Master Teachers as Professional Developers: Managing Conflicting Versions of Professionalism

ERIC Educational Resources Information Center

Montecinos, Carmen; Pino, Mauricio; Campos-Martinez, Javier; Domínguez, Rosario; Carreño, Claudia

2014-01-01

As education's main workforce, teachers have been the target of policies designed to shape and affirm new versions of professionalism. This paper examines this issue as it is exemplified by the Teachers of Teachers Network (TTN), a program developed by Chile's Ministry of Education. As a program designed to identify and reward high quality…

Evaluation of the ORCHIDEE ecosystem model over Africa against 25 years of satellite-based water and carbon measurements

NASA Astrophysics Data System (ADS)

Traore, Abdoul Khadre; Ciais, Philippe; Vuichard, Nicolas; Poulter, Benjamin; Viovy, Nicolas; Guimberteau, Matthieu; Jung, Martin; Myneni, Ranga; Fisher, Joshua B.

2014-08-01

Few studies have evaluated land surface models for African ecosystems. Here we evaluate the Organizing Carbon and Hydrology in Dynamic Ecosystems (ORCHIDEE) process-based model for the interannual variability (IAV) of the fraction of absorbed active radiation, the gross primary productivity (GPP), soil moisture, and evapotranspiration (ET). Two ORCHIDEE versions are tested, which differ by their soil hydrology parameterization, one with a two-layer simple bucket and the other a more complex 11-layer soil-water diffusion. In addition, we evaluate the sensitivity of climate forcing data, atmospheric CO2, and soil depth. Beside a very generic vegetation parameterization, ORCHIDEE simulates rather well the IAV of GPP and ET (0.5 < r < 0.9 interannual correlation) over Africa except in forestlands. The ORCHIDEE 11-layer version outperforms the two-layer version for simulating IAV of soil moisture, whereas both versions have similar performance of GPP and ET. Effects of CO2 trends, and of variable soil depth on the IAV of GPP, ET, and soil moisture are small, although these drivers influence the trends of these variables. The meteorological forcing data appear to be quite important for faithfully reproducing the IAV of simulated variables, suggesting that in regions with sparse weather station data, the model uncertainty is strongly related to uncertain meteorological forcing. Simulated variables are positively and strongly correlated with precipitation but negatively and weakly correlated with temperature and solar radiation. Model-derived and observation-based sensitivities are in agreement for the driving role of precipitation. However, the modeled GPP is too sensitive to precipitation, suggesting that processes such as increased water use efficiency during drought need to be incorporated in ORCHIDEE.

Development of the PedsQL™ Epilepsy Module: Focus group and cognitive interviews.

PubMed

Follansbee-Junger, Katherine W; Mann, Krista A; Guilfoyle, Shanna M; Morita, Diego A; Varni, James W; Modi, Avani C

2016-09-01

Youth with epilepsy have impaired health-related quality of life (HRQOL). Existing epilepsy-specific HRQOL measures are limited by not having parallel self- and parent-proxy versions, having a restricted age range, not being inclusive of children with developmental disabilities, or being too lengthy for use in a clinical setting. Generic HRQOL measures do not adequately capture the idiosyncrasies of epilepsy. The purpose of the present study was to develop items and content validity for the PedsQL™ Epilepsy Module. An iterative qualitative process of conducting focus group interviews with families of children with epilepsy, obtaining expert input, and conducting cognitive interviews and debriefing was utilized to develop empirically derived content for the instrument. Eleven health providers with expertise in pediatric epilepsy from across the country provided feedback on the conceptual model and content, including epileptologists, nurse practitioners, social workers, and psychologists. Ten pediatric patients (age 4-16years) with a diagnosis of epilepsy and 11 parents participated in focus groups. Thirteen pediatric patients (age 5-17years) and 17 parents participated in cognitive interviews. Focus groups, expert input, and cognitive debriefing resulted in 6 final domains including restrictions, seizure management, cognitive/executive functioning, social, sleep/fatigue, and mood/behavior. Patient self-report versions ranged from 30 to 33 items and parent proxy-report versions ranged from 26 to 33 items, with the toddler and young child versions having fewer items. Standardized qualitative methodology was employed to develop the items and content for the novel PedsQL™ Epilepsy Module. The PedsQL™ Epilepsy Module has the potential to enhance clinical decision-making in pediatric epilepsy by capturing and monitoring important patient-identified contributors to HRQOL. Copyright © 2016 Elsevier Inc. All rights reserved.

RT-PCR for detection of all seven genotypes of Lyssavirus genus.

PubMed

Vázquez-Morón, S; Avellón, A; Echevarría, J E

2006-08-01

The Lyssavirus genus includes seven species or genotypes named 1-7. Rabies genotypes correlate with geographical distribution and specific hosts. Co-circulation of different lyssaviruses, imported cases, and the presence of unknown viruses, such as Aravan, Khujand, Irkut and West Caucasian Bat Virus, make it necessary to use generic methods able to detect all lyssaviruses. Primer sequences were chosen from conserved regions in all genotypes in order to optimise a generic RT-PCR. Serial dilutions of 12 RNA extracts from all seven Lyssavirus genotypes were examined to compare the sensitivity of the RT-PCR standardised in this study with a published RT-PCR optimised for EBLV1 detection and capable of amplifying RNA from all seven lyssaviruses. All seven genotypes were detected by both RT-PCRs, however, the sensitivity was higher with the new version of the test. Twenty samples submitted for rabies diagnosis were tested by the new RT-PCR. Eight out of 20 samples from six dogs, one horse and one bat were found positive, in agreement with immunofluorescence results. Seven samples from terrestrial mammals were genotype 1 and one from a bat was genotype 5. In conclusion, this method can be used to complement immunofluorescence for the diagnosis of rabies, enabling the detection of unexpected lyssaviruses during rabies surveillance.

Projected savings through public health voluntary licences of HIV drugs negotiated by the Medicines Patent Pool (MPP).

PubMed

Juneja, Sandeep; Gupta, Aastha; Moon, Suerie; Resch, Stephen

2017-01-01

The Medicines Patent Pool (MPP) was established in 2010 to ensure timely access to low-cost generic versions of patented antiretroviral (ARV) medicines in low- and middle-income countries (LMICs) through the negotiation of voluntary licences with patent holders. While robust data on the savings generated by MPP and other major global public health initiatives is important, it is also difficult to quantify. In this study, we estimate the savings generated by licences negotiated by the MPP for ARV medicines to treat HIV/AIDS in LMICs for the period 2010-2028 and generate a cost-benefit ratio-based on people living with HIV (PLHIVs) in any new countries which gain access to an ARV due to MPP licences and the price differential between originator's tiered price and generics price, within the period where that ARV is patented. We found that the direct savings generated by the MPP are estimated to be USD 2.3 billion (net present value) by 2028, representing an estimated cost-benefit ratio of 1:43, which means for every USD 1 spent on MPP, the global public health community saves USD 43. The saving of USD 2.3 billion is equivalent to more than 24 million PLHIV receiving first-line ART in LMICs for 1 year at average prices today.

Designing and validation of a yoga-based intervention for obsessive compulsive disorder.

PubMed

Bhat, Shubha; Varambally, Shivarama; Karmani, Sneha; Govindaraj, Ramajayam; Gangadhar, B N

2016-06-01

Some yoga-based practices have been found to be useful for patients with obsessive compulsive disorder (OCD). The authors could not find a validated yoga therapy module available for OCD. This study attempted to formulate a generic yoga-based intervention module for OCD. A yoga module was designed based on traditional and contemporary yoga literature. The module was sent to 10 yoga experts for content validation. The experts rated the usefulness of the practices on a scale of 1-5 (5 = extremely useful). The final version of the module was pilot-tested on patients with OCD (n = 17) for both feasibility and effect on symptoms. Eighty-eight per cent (22 out of 25) of the items in the initial module were retained, with modifications in the module as suggested by the experts along with patients' inputs and authors' experience. The module was found to be feasible and showed an improvement in symptoms of OCD on total Yale-Brown Obsessive-Compulsive Scale (YBOCS) score (p = 0.001). A generic yoga therapy module for OCD was validated by experts in the field and found feasible to practice in patients. A decrease in the symptom scores was also found following yoga practice of 2 weeks. Further clinical validation is warranted to confirm efficacy.

Hybrid Wavelet De-noising and Rank-Set Pair Analysis approach for forecasting hydro-meteorological time series

NASA Astrophysics Data System (ADS)

WANG, D.; Wang, Y.; Zeng, X.

2017-12-01

Accurate, fast forecasting of hydro-meteorological time series is presently a major challenge in drought and flood mitigation. This paper proposes a hybrid approach, Wavelet De-noising (WD) and Rank-Set Pair Analysis (RSPA), that takes full advantage of a combination of the two approaches to improve forecasts of hydro-meteorological time series. WD allows decomposition and reconstruction of a time series by the wavelet transform, and hence separation of the noise from the original series. RSPA, a more reliable and efficient version of Set Pair Analysis, is integrated with WD to form the hybrid WD-RSPA approach. Two types of hydro-meteorological data sets with different characteristics and different levels of human influences at some representative stations are used to illustrate the WD-RSPA approach. The approach is also compared to three other generic methods: the conventional Auto Regressive Integrated Moving Average (ARIMA) method, Artificial Neural Networks (ANNs) (BP-error Back Propagation, MLP-Multilayer Perceptron and RBF-Radial Basis Function), and RSPA alone. Nine error metrics are used to evaluate the model performance. The results show that WD-RSPA is accurate, feasible, and effective. In particular, WD-RSPA is found to be the best among the various generic methods compared in this paper, even when the extreme events are included within a time series.

A look back at 2009: one step forward, two steps back.

PubMed

2010-04-01

In 2009, we examined 104 new brand name products or new indications for existing products in the French edition of Prescrire. Only 3 of these 104 "innovations" provided some therapeutic advantage, while 19 had clearly unfavourable risk-benefit balances. Marketing authorisations are failing to adequately protect patients. A number of cheaper generic versions of useful drugs were introduced to the market, while BigPharma's anticompetitive practices were aimed at slowing the growth of generics manufacturers. The quality of over-the-counter drugs marketed for self-medication, especially "umbrella" brands, left much to be desired. Consumer protection is clearly not the primary concern of the European (EMA) and French (Afssaps) drug regulatory agencies. They remain too financially dependent on drug companies; hesitate to withdraw dangerous drugs from the market; and withhold drug safety data. Other signs of drug companies' excessive influence, at patients' expense, include drug pricing that bears little relation to therapeutic advantage (in oncology, for example); the financial dependence of many patient groups on drug companies; the European Commission's attempts to authorise direct-to-consumer advertising and to allow the pharmaceutical sector to tighten its grip on health information, including pharmacovigilance data. Governments must assume their responsibilities, and patients and the healthcare profession must resist BigPharma's increasing involvement in all spheres of patient care.

'Government Patent Use': A Legal Approach To Reducing Drug Spending.

PubMed

Kapczynski, Amy; Kesselheim, Aaron S

2016-05-01

The high cost of patent-protected brand-name drugs can strain budgets and curb the widespread use of new medicines. An example is the case of direct-acting antiviral drugs for the treatment of hepatitis C. While prices for these drugs have come down in recent months, they still create barriers to treatment. Additionally, prescribing restrictions imposed by insurers put patients at increased risk of medical complications and contribute to transmission of the hepatitis C virus. We propose that the federal government invoke its power under an existing "government patent use" law to reduce excessive prices for important patent-protected medicines. Using this law would permit the government to procure generic versions of patented drugs and in exchange pay the patent-holding companies reasonable royalties to compensate them for research and development. This would allow patients in federal programs, and perhaps beyond, to be treated with inexpensive generic medicines according to clinical need-meaning that many more patients could be reached for no more, and perhaps far less, money than is currently spent. Another benefit would be a reduction in the opportunity for companies to extract monopoly profits that far exceed their risk-adjusted costs of research and development. Project HOPE—The People-to-People Health Foundation, Inc.

Liposomal amphotericin B as a treatment for human leishmaniasis

PubMed Central

Balasegaram, Manica; Ritmeijer, Koert; Lima, Maria Angeles; Burza, Sakib; Ortiz Genovese, Gemma; Milani, Barbara; Gaspani, Sara; Potet, Julien; Chappuis, François

2012-01-01

Introduction: Leishmaniasis is a parasitic disease transmitted by phlebotomine sandflies. Between 700,000 and 1.2 million cases of cutaneous leishmaniasis and between 200,000 and 400,000 cases of visceral leishmaniasis (VL), which is fatal if left untreated, occur annually worldwide. Liposomal amphotericin B (LAMB), alone or in combination with other drugs, has been extensively studied as VL treatment, but data on routine field use are limited, and several challenges to patients' access to this life-saving drug remain. Areas covered: This article provides a review of clinical studies on LAMB for VL and other forms of leishmaniasis. The current development of generic versions of LAMB and related challenges are also discussed. Expert opinion: LAMB proved to be highly efficacious and safe in over 8000 VL patients treated by MÉdecins Sans Frontières in South Asia, and its use was feasible even at primary healthcare level. Despite requiring higher doses, LAMB is the drug of choice to treat vulnerable groups (e.g., pregnant or HIV positive) and relapsing VL patients in East Africa. LAMB should be included in national VL guidelines and registered in all VL endemic countries. Its cost should be further reduced and regulatory pathways to prove bioequivalence for generic LAMB products should be implemented. PMID:23167833

A generic flexible and robust approach for intelligent real-time video-surveillance systems

NASA Astrophysics Data System (ADS)

Desurmont, Xavier; Delaigle, Jean-Francois; Bastide, Arnaud; Macq, Benoit

2004-05-01

In this article we present a generic, flexible and robust approach for an intelligent real-time video-surveillance system. A previous version of the system was presented in [1]. The goal of these advanced tools is to provide help to operators by detecting events of interest in visual scenes and highlighting alarms and compute statistics. The proposed system is a multi-camera platform able to handle different standards of video inputs (composite, IP, IEEE1394 ) and which can basically compress (MPEG4), store and display them. This platform also integrates advanced video analysis tools, such as motion detection, segmentation, tracking and interpretation. The design of the architecture is optimised to playback, display, and process video flows in an efficient way for video-surveillance application. The implementation is distributed on a scalable computer cluster based on Linux and IP network. It relies on POSIX threads for multitasking scheduling. Data flows are transmitted between the different modules using multicast technology and under control of a TCP-based command network (e.g. for bandwidth occupation control). We report here some results and we show the potential use of such a flexible system in third generation video surveillance system. We illustrate the interest of the system in a real case study, which is the indoor surveillance.

Using a behaviour change techniques taxonomy to identify active ingredients within trials of implementation interventions for diabetes care.

PubMed

Presseau, Justin; Ivers, Noah M; Newham, James J; Knittle, Keegan; Danko, Kristin J; Grimshaw, Jeremy M

2015-04-23

Methodological guidelines for intervention reporting emphasise describing intervention content in detail. Despite this, systematic reviews of quality improvement (QI) implementation interventions continue to be limited by a lack of clarity and detail regarding the intervention content being evaluated. We aimed to apply the recently developed Behaviour Change Techniques Taxonomy version 1 (BCTTv1) to trials of implementation interventions for managing diabetes to assess the capacity and utility of this taxonomy for characterising active ingredients. Three psychologists independently coded a random sample of 23 trials of healthcare system, provider- and/or patient-focused implementation interventions from a systematic review that included 142 such studies. Intervention content was coded using the BCTTv1, which describes 93 behaviour change techniques (BCTs) grouped within 16 categories. We supplemented the generic coding instructions within the BCTTv1 with decision rules and examples from this literature. Less than a quarter of possible BCTs within the BCTTv1 were identified. For implementation interventions targeting providers, the most commonly identified BCTs included the following: adding objects to the environment, prompts/cues, instruction on how to perform the behaviour, credible source, goal setting (outcome), feedback on outcome of behaviour, and social support (practical). For implementation interventions also targeting patients, the most commonly identified BCTs included the following: prompts/cues, instruction on how to perform the behaviour, information about health consequences, restructuring the social environment, adding objects to the environment, social support (practical), and goal setting (behaviour). The BCTTv1 mapped well onto implementation interventions directly targeting clinicians and patients and could also be used to examine the impact of system-level interventions on clinician and patient behaviour. The BCTTv1 can be used to characterise the active ingredients in trials of implementation interventions and provides specificity of content beyond what is given by broader intervention labels. Identification of BCTs may provide a more helpful means of accumulating knowledge on the content used in trials of implementation interventions, which may help to better inform replication efforts. In addition, prospective use of a behaviour change techniques taxonomy for developing and reporting intervention content would further aid in building a cumulative science of effective implementation interventions.

Impaired health-related quality of life in children and adolescents with chronic conditions: a comparative analysis of 10 disease clusters and 33 disease categories/severities utilizing the PedsQL 4.0 Generic Core Scales.

PubMed

Varni, James W; Limbers, Christine A; Burwinkle, Tasha M

2007-07-16

Advances in biomedical science and technology have resulted in dramatic improvements in the healthcare of pediatric chronic conditions. With enhanced survival, health-related quality of life (HRQOL) issues have become more salient. The objectives of this study were to compare generic HRQOL across ten chronic disease clusters and 33 disease categories/severities from the perspectives of patients and parents. Comparisons were also benchmarked with healthy children data. The analyses were based on over 2,500 pediatric patients from 10 physician-diagnosed disease clusters and 33 disease categories/severities and over 9,500 healthy children utilizing the PedsQL 4.0 Generic Core Scales. Patients were recruited from general pediatric clinics, subspecialty clinics, and hospitals. Pediatric patients with diabetes, gastrointestinal conditions, cardiac conditions, asthma, obesity, end stage renal disease, psychiatric disorders, cancer, rheumatologic conditions, and cerebral palsy self-reported progressively more impaired overall HRQOL than healthy children, respectively, with medium to large effect sizes. Patients with cerebral palsy self-reported the most impaired HRQOL, while patients with diabetes self-reported the best HRQOL. Parent proxy-reports generally paralleled patient self-report, with several notable differences. The results demonstrate differential effects of pediatric chronic conditions on patient HRQOL across diseases clusters, categories, and severities utilizing the PedsQL 4.0 Generic Core Scales from the perspectives of pediatric patients and parents. The data contained within this study represents a larger and more diverse population of pediatric patients with chronic conditions than previously reported in the extant literature. The findings contribute important information on the differential effects of pediatric chronic conditions on generic HRQOL from the perspectives of children and parents utilizing the PedsQL 4.0 Generic Core Scales. These findings with the PedsQL have clinical implications for the healthcare services provided for children with chronic health conditions. Given the degree of reported impairment based on PedsQL scores across different pediatric chronic conditions, the need for more efficacious targeted treatments for those pediatric patients with more severely impaired HRQOL is clearly and urgently indicated.

Impaired health-related quality of life in children and adolescents with chronic conditions: a comparative analysis of 10 disease clusters and 33 disease categories/severities utilizing the PedsQL™ 4.0 Generic Core Scales

PubMed Central

Varni, James W; Limbers, Christine A; Burwinkle, Tasha M

2007-01-01

Background Advances in biomedical science and technology have resulted in dramatic improvements in the healthcare of pediatric chronic conditions. With enhanced survival, health-related quality of life (HRQOL) issues have become more salient. The objectives of this study were to compare generic HRQOL across ten chronic disease clusters and 33 disease categories/severities from the perspectives of patients and parents. Comparisons were also benchmarked with healthy children data. Methods The analyses were based on over 2,500 pediatric patients from 10 physician-diagnosed disease clusters and 33 disease categories/severities and over 9,500 healthy children utilizing the PedsQL™ 4.0 Generic Core Scales. Patients were recruited from general pediatric clinics, subspecialty clinics, and hospitals. Results Pediatric patients with diabetes, gastrointestinal conditions, cardiac conditions, asthma, obesity, end stage renal disease, psychiatric disorders, cancer, rheumatologic conditions, and cerebral palsy self-reported progressively more impaired overall HRQOL than healthy children, respectively, with medium to large effect sizes. Patients with cerebral palsy self-reported the most impaired HRQOL, while patients with diabetes self-reported the best HRQOL. Parent proxy-reports generally paralleled patient self-report, with several notable differences. Conclusion The results demonstrate differential effects of pediatric chronic conditions on patient HRQOL across diseases clusters, categories, and severities utilizing the PedsQL™ 4.0 Generic Core Scales from the perspectives of pediatric patients and parents. The data contained within this study represents a larger and more diverse population of pediatric patients with chronic conditions than previously reported in the extant literature. The findings contribute important information on the differential effects of pediatric chronic conditions on generic HRQOL from the perspectives of children and parents utilizing the PedsQL™ 4.0 Generic Core Scales. These findings with the PedsQL™ have clinical implications for the healthcare services provided for children with chronic health conditions. Given the degree of reported impairment based on PedsQL™ scores across different pediatric chronic conditions, the need for more efficacious targeted treatments for those pediatric patients with more severely impaired HRQOL is clearly and urgently indicated. PMID:17634123

Generic Amplicon Deep Sequencing to Determine Ilarvirus Species Diversity in Australian Prunus

PubMed Central

Kinoti, Wycliff M.; Constable, Fiona E.; Nancarrow, Narelle; Plummer, Kim M.; Rodoni, Brendan

2017-01-01

The distribution of Ilarvirus species populations amongst 61 Australian Prunus trees was determined by next generation sequencing (NGS) of amplicons generated using a genus-based generic RT-PCR targeting a conserved region of the Ilarvirus RNA2 component that encodes the RNA dependent RNA polymerase (RdRp) gene. Presence of Ilarvirus sequences in each positive sample was further validated by Sanger sequencing of cloned amplicons of regions of each of RNA1, RNA2 and/or RNA3 that were generated by species specific PCRs and by metagenomic NGS. Prunus necrotic ringspot virus (PNRSV) was the most frequently detected Ilarvirus, occurring in 48 of the 61 Ilarvirus-positive trees and Prune dwarf virus (PDV) and Apple mosaic virus (ApMV) were detected in three trees and one tree, respectively. American plum line pattern virus (APLPV) was detected in three trees and represents the first report of APLPV detection in Australia. Two novel and distinct groups of Ilarvirus-like RNA2 amplicon sequences were also identified in several trees by the generic amplicon NGS approach. The high read depth from the amplicon NGS of the generic PCR products allowed the detection of distinct RNA2 RdRp sequence variant populations of PNRSV, PDV, ApMV, APLPV and the two novel Ilarvirus-like sequences. Mixed infections of ilarviruses were also detected in seven Prunus trees. Sanger sequencing of specific RNA1, RNA2, and/or RNA3 genome segments of each virus and total nucleic acid metagenomics NGS confirmed the presence of PNRSV, PDV, ApMV and APLPV detected by RNA2 generic amplicon NGS. However, the two novel groups of Ilarvirus-like RNA2 amplicon sequences detected by the generic amplicon NGS could not be associated to the presence of sequence from RNA1 or RNA3 genome segments or full Ilarvirus genomes, and their origin is unclear. This work highlights the sensitivity of genus-specific amplicon NGS in detection of virus sequences and their distinct populations in multiple samples, and the need for a standardized approach to accurately determine what constitutes an active, viable virus infection after detection by molecular based methods. PMID:28713347

Generic Amplicon Deep Sequencing to Determine Ilarvirus Species Diversity in Australian Prunus.

PubMed

Kinoti, Wycliff M; Constable, Fiona E; Nancarrow, Narelle; Plummer, Kim M; Rodoni, Brendan

2017-01-01

The distribution of Ilarvirus species populations amongst 61 Australian Prunus trees was determined by next generation sequencing (NGS) of amplicons generated using a genus-based generic RT-PCR targeting a conserved region of the Ilarvirus RNA2 component that encodes the RNA dependent RNA polymerase (RdRp) gene. Presence of Ilarvirus sequences in each positive sample was further validated by Sanger sequencing of cloned amplicons of regions of each of RNA1, RNA2 and/or RNA3 that were generated by species specific PCRs and by metagenomic NGS. Prunus necrotic ringspot virus (PNRSV) was the most frequently detected Ilarvirus , occurring in 48 of the 61 Ilarvirus -positive trees and Prune dwarf virus (PDV) and Apple mosaic virus (ApMV) were detected in three trees and one tree, respectively. American plum line pattern virus (APLPV) was detected in three trees and represents the first report of APLPV detection in Australia. Two novel and distinct groups of Ilarvirus -like RNA2 amplicon sequences were also identified in several trees by the generic amplicon NGS approach. The high read depth from the amplicon NGS of the generic PCR products allowed the detection of distinct RNA2 RdRp sequence variant populations of PNRSV, PDV, ApMV, APLPV and the two novel Ilarvirus -like sequences. Mixed infections of ilarviruses were also detected in seven Prunus trees. Sanger sequencing of specific RNA1, RNA2, and/or RNA3 genome segments of each virus and total nucleic acid metagenomics NGS confirmed the presence of PNRSV, PDV, ApMV and APLPV detected by RNA2 generic amplicon NGS. However, the two novel groups of Ilarvirus -like RNA2 amplicon sequences detected by the generic amplicon NGS could not be associated to the presence of sequence from RNA1 or RNA3 genome segments or full Ilarvirus genomes, and their origin is unclear. This work highlights the sensitivity of genus-specific amplicon NGS in detection of virus sequences and their distinct populations in multiple samples, and the need for a standardized approach to accurately determine what constitutes an active, viable virus infection after detection by molecular based methods.

Productivity-enhancing work innovations: remedies for what ails hospitals?

PubMed

Hames, D S

1991-01-01

Prospective pricing, the proliferation of alternative delivery systems, and the demands of third party payers and corporate employers for the containment of health care costs have engendered the keen interest of hospital executives seeking strategies for improving labor productivity. Despite this interest, the relevant literature suggests that few work innovations designed to enhance labor productivity have been implemented in hospitals. This article describes generic versions of four such work innovations--quality circles, union-management committees, autonomous work groups, and gainsharing--and discusses relevant research indicating the types of benefits gained from each and the reasons why some have failed. Each innovation's potential for success in hospitals is evaluated, and suggestions for increasing the effectiveness of each in hospitals is offered.

Type IIB Colliding Plane Waves

NASA Astrophysics Data System (ADS)

Gutperle, M.; Pioline, B.

2003-09-01

Four-dimensional colliding plane wave (CPW) solutions have played an important role in understanding the classical non-linearities of Einstein's equations. In this note, we investigate CPW solutions in 2n+2-dimensional Einstein gravity with a n+1-form flux. By using an isomorphism with the four-dimensional problem, we construct exact solutions analogous to the Szekeres vacuum solution in four dimensions. The higher-dimensional versions of the Khan-Penrose and Bell-Szekeres CPW solutions are studied perturbatively in the vicinity of the light-cone. We find that under small perturbations, a curvature singularity is generically produced, leading to both space-like and time-like singularities. For n = 4, our results pertain to the collision of two ten-dimensional type-IIB Blau-Figueroa o'Farrill-Hull-Papadopoulos plane waves.

The Case for Absolute Ligand Discrimination: Modeling Information Processing and Decision by Immune T Cells

NASA Astrophysics Data System (ADS)

François, Paul; Altan-Bonnet, Grégoire

2016-03-01

Some cells have to take decision based on the quality of surroundings ligands, almost irrespective of their quantity, a problem we name "absolute discrimination". An example of absolute discrimination is recognition of not-self by immune T Cells. We show how the problem of absolute discrimination can be solved by a process called "adaptive sorting". We review several implementations of adaptive sorting, as well as its generic properties such as antagonism. We show how kinetic proofreading with negative feedback implement an approximate version of adaptive sorting in the immune context. Finally, we revisit the decision problem at the cell population level, showing how phenotypic variability and feedbacks between population and single cells are crucial for proper decision.

Space station protective coating development

NASA Technical Reports Server (NTRS)

Pippin, H. G.; Hill, S. G.

1989-01-01

A generic list of Space Station surfaces and candidate material types is provided. Environmental exposures and performance requirements for the different Space Station surfaces are listed. Coating materials and the processing required to produce a viable system, and appropriate environmental simulation test facilities are being developed. Mass loss data from the original version of the atomic oxygen test chamber and the improved facility; additional environmental exposures performed on candidate materials; and materials properties measurements on candidate coatings to determine the effects of the exposures are discussed. Methodologies of production, and coating materials, used to produce the large scale demonstration articles are described. The electronic data base developed for the contract is also described. The test chamber to be used for exposure of materials to atomic oxygen was built.

Track reconstruction at LHC as a collaborative data challenge use case with RAMP

NASA Astrophysics Data System (ADS)

Amrouche, Sabrina; Braun, Nils; Calafiura, Paolo; Farrell, Steven; Gemmler, Jochen; Germain, Cécile; Gligorov, Vladimir Vava; Golling, Tobias; Gray, Heather; Guyon, Isabelle; Hushchyn, Mikhail; Innocente, Vincenzo; Kégl, Balázs; Neuhaus, Sara; Rousseau, David; Salzburger, Andreas; Ustyuzhanin, Andrei; Vlimant, Jean-Roch; Wessel, Christian; Yilmaz, Yetkin

2017-08-01

Charged particle track reconstruction is a major component of data-processing in high-energy physics experiments such as those at the Large Hadron Collider (LHC), and is foreseen to become more and more challenging with higher collision rates. A simplified two-dimensional version of the track reconstruction problem is set up on a collaborative platform, RAMP, in order for the developers to prototype and test new ideas. A small-scale competition was held during the Connecting The Dots / Intelligent Trackers 2017 (CTDWIT 2017) workshop. Despite the short time scale, a number of different approaches have been developed and compared along a single score metric, which was kept generic enough to accommodate a summarized performance in terms of both efficiency and fake rates.

Dissipative Quantum Control of a Spin Chain

NASA Astrophysics Data System (ADS)

Morigi, Giovanna; Eschner, Jürgen; Cormick, Cecilia; Lin, Yiheng; Leibfried, Dietrich; Wineland, David J.

2015-11-01

A protocol is discussed for preparing a spin chain in a generic many-body state in the asymptotic limit of tailored nonunitary dynamics. The dynamics require the spectral resolution of the target state, optimized coherent pulses, engineered dissipation, and feedback. As an example, we discuss the preparation of an entangled antiferromagnetic state, and argue that the procedure can be applied to chains of trapped ions or Rydberg atoms.

Phonological and Orthographic Overlap Effects in Fast and Masked Priming

PubMed Central

Frisson, Steven; Bélanger, Nathalie N.; Rayner, Keith

2014-01-01

We investigated how orthographic and phonological information is activated during reading, using a fast priming task, and during single word recognition, using masked priming. Specifically, different types of overlap between prime and target were contrasted: high orthographic and high phonological overlap (track-crack), high orthographic and low phonological overlap (bear-gear), or low orthographic and high phonological overlap (fruit-chute). In addition, we examined whether (orthographic) beginning overlap (swoop-swoon) yielded the same priming pattern as end (rhyme) overlap (track-crack). Prime durations were 32 and 50ms in the fast priming version, and 50ms in the masked priming version, and mode of presentation (prime and target in lower case) was identical. The fast priming experiment showed facilitatory priming effects when both orthography and phonology overlapped, with no apparent differences between beginning and end overlap pairs. Facilitation was also found when prime and target only overlapped orthographically. In contrast, the masked priming experiment showed inhibition for both types of end overlap pairs (with and without phonological overlap), and no difference for begin overlap items. When prime and target only shared principally phonological information, facilitation was only found with a long prime duration in the fast priming experiment, while no differences were found in the masked priming version. These contrasting results suggest that fast priming and masked priming do not necessarily tap into the same type of processing. PMID:24365065

DOE Office of Scientific and Technical Information (OSTI.GOV)

Andersen, G.L.; He, Z.; DeSantis, T.Z.

Microarrays have proven to be a useful and high-throughput method to provide targeted DNA sequence information for up to many thousands of specific genetic regions in a single test. A microarray consists of multiple DNA oligonucleotide probes that, under high stringency conditions, hybridize only to specific complementary nucleic acid sequences (targets). A fluorescent signal indicates the presence and, in many cases, the abundance of genetic regions of interest. In this chapter we will look at how microarrays are used in microbial ecology, especially with the recent increase in microbial community DNA sequence data. Of particular interest to microbial ecologists, phylogeneticmore » microarrays are used for the analysis of phylotypes in a community and functional gene arrays are used for the analysis of functional genes, and, by inference, phylotypes in environmental samples. A phylogenetic microarray that has been developed by the Andersen laboratory, the PhyloChip, will be discussed as an example of a microarray that targets the known diversity within the 16S rRNA gene to determine microbial community composition. Using multiple, confirmatory probes to increase the confidence of detection and a mismatch probe for every perfect match probe to minimize the effect of cross-hybridization by non-target regions, the PhyloChip is able to simultaneously identify any of thousands of taxa present in an environmental sample. The PhyloChip is shown to reveal greater diversity within a community than rRNA gene sequencing due to the placement of the entire gene product on the microarray compared with the analysis of up to thousands of individual molecules by traditional sequencing methods. A functional gene array that has been developed by the Zhou laboratory, the GeoChip, will be discussed as an example of a microarray that dynamically identifies functional activities of multiple members within a community. The recent version of GeoChip contains more than 24,000 50mer oligonucleotide probes and covers more than 10,000 gene sequences in 150 gene categories involved in carbon, nitrogen, sulfur, and phosphorus cycling, metal resistance and reduction, and organic contaminant degradation. GeoChip can be used as a generic tool for microbial community analysis, and also link microbial community structure to ecosystem functioning. Examples of the application of both arrays in different environmental samples will be described in the two subsequent sections.« less

Comparison of Outcomes Following a Switch From a Brand to an Authorized Versus Independent Generic Drug.

PubMed

Hansen, R A; Qian, J; Berg, R L; Linneman, J G; Seoane-Vazquez, E; Dutcher, S; Raofi, S; Page, C D; Peissig, P L

2018-02-01

Authorized generics are identical in formulation to brand drugs, manufactured by the brand company but marketed as a generic. Generics, marketed by generic manufacturers, are required to demonstrate pharmaceutical and bioequivalence to the brand drug, but repetition of clinical trials is not required. This retrospective cohort study compared outcomes for generics and authorized generics, which serves as a generic vs. brand proxy that minimizes bias against generics. For the seven drugs studied between 1999 and 2014, 5,234 unique patients were on brand drugs prior to generic entry and 4,900 (93.6%) switched to a generic. During the 12 months following the brand-to-generic switch, patients using generics vs. authorized generics were similar in terms of outpatient visits, urgent care visits, hospitalizations, and medication discontinuation. The likelihood of emergency department (ED) visits was slightly higher for authorized generics compared with generics. These data suggest that generics were clinically no worse than their proxy brand comparators. © 2017 American Society for Clinical Pharmacology and Therapeutics.

Tensor Fukunaga-Koontz transform for small target detection in infrared images

NASA Astrophysics Data System (ADS)

Liu, Ruiming; Wang, Jingzhuo; Yang, Huizhen; Gong, Chenglong; Zhou, Yuanshen; Liu, Lipeng; Zhang, Zhen; Shen, Shuli

2016-09-01

Infrared small targets detection plays a crucial role in warning and tracking systems. Some novel methods based on pattern recognition technology catch much attention from researchers. However, those classic methods must reshape images into vectors with the high dimensionality. Moreover, vectorizing breaks the natural structure and correlations in the image data. Image representation based on tensor treats images as matrices and can hold the natural structure and correlation information. So tensor algorithms have better classification performance than vector algorithms. Fukunaga-Koontz transform is one of classification algorithms and it is a vector version method with the disadvantage of all vector algorithms. In this paper, we first extended the Fukunaga-Koontz transform into its tensor version, tensor Fukunaga-Koontz transform. Then we designed a method based on tensor Fukunaga-Koontz transform for detecting targets and used it to detect small targets in infrared images. The experimental results, comparison through signal-to-clutter, signal-to-clutter gain and background suppression factor, have validated the advantage of the target detection based on the tensor Fukunaga-Koontz transform over that based on the Fukunaga-Koontz transform.

Multi-language translation and cross-cultural adaptation of the OARSI/OMERACT measure of intermittent and constant osteoarthritis pain (ICOAP).

PubMed

Maillefert, J F; Kloppenburg, M; Fernandes, L; Punzi, L; Günther, K-P; Martin Mola, E; Lohmander, L S; Pavelka, K; Lopez-Olivo, M A; Dougados, M; Hawker, G A

2009-10-01

To conduct a multi-language translation and cross-cultural adaptation of the Intermittent and Constant OsteoArthritis Pain (ICOAP) questionnaire for hip and knee osteoarthritis (OA). The questionnaires were translated and cross-culturally adapted in parallel, using a common protocol, into the following languages: Czech, Dutch, French (France), German, Italian, Norwegian, Spanish (Castillan), North and Central American Spanish, Swedish. The process was conducted following five steps: (1)--independent translation into the target language by two or three persons; (2)--consensus meeting to obtain a single preliminary translated version; (3)--backward translation by an independent bilingual native English speaker, blinded to the English original version; (4)--final version produced by a multidisciplinary consensus committee; (5)--pre-testing of the final version with 10-20 target-language-native hip and knee OA patients. The process could be followed and completed in all countries. Only slight differences were identified in the structure of the sentences between the original and the translated versions. A large majority of the patients felt that the questionnaire was easy to understand and complete. Only a few minor criticisms were expressed. Moreover, a majority of patients found the concepts of constant pain and pain that comes and goes to be of a great pertinence and were very happy with the distinction. The ICOAP questionnaire is now available for multi-center international studies.

Validation of the Spanish Version of the Emotional Skills Assessment Process (ESAP) with College Students in Mexico

ERIC Educational Resources Information Center

Teliz Triujeque, Rosalia

2009-01-01

The major purpose of the study was to determine the construct validity of the Spanish version of the Emotional Skills Assessment Process (ESAP) in a targeted population of agriculture college students in Mexico. The ESAP is a self assessment approach that helps students to identify and understand emotional intelligence skills relevant for…

Equivalence of complex drug products: advances in and challenges for current regulatory frameworks.

PubMed

Hussaarts, Leonie; Mühlebach, Stefan; Shah, Vinod P; McNeil, Scott; Borchard, Gerrit; Flühmann, Beat; Weinstein, Vera; Neervannan, Sesha; Griffiths, Elwyn; Jiang, Wenlei; Wolff-Holz, Elena; Crommelin, Daan J A; de Vlieger, Jon S B

2017-11-01

Biotechnology and nanotechnology provide a growing number of innovator-driven complex drug products and their copy versions. Biologics exemplify one category of complex drugs, but there are also nonbiological complex drug products, including many nanomedicines, such as iron-carbohydrate complexes, drug-carrying liposomes or emulsions, and glatiramoids. In this white paper, which stems from a 1-day conference at the New York Academy of Sciences, we discuss regulatory frameworks in use worldwide (e.g., the U.S. Food and Drug Administration, the European Medicines Agency, the World Health Organization) to approve these complex drug products and their follow-on versions. One of the key questions remains how to assess equivalence of these complex products. We identify a number of points for which consensus was found among the stakeholders who were present: scientists from innovator and generic/follow-on companies, academia, and regulatory bodies from different parts of the world. A number of topics requiring follow-up were identified: (1) assessment of critical attributes to establish equivalence for follow-on versions, (2) the need to publish scientific findings in the public domain to further progress in the field, (3) the necessity to develop worldwide consensus regarding nomenclature and labeling of these complex products, and (4) regulatory actions when substandard complex drug products are identified. © 2017 The Authors. Annals of the New York Academy of Sciences published by Wiley Periodicals, Inc. on behalf of New York Academy of Sciences.

[Development of the Portuguese version of MOS SF-36. Part I. Cultural and linguistic adaptation].

PubMed

Ferreira, P L

2000-01-01

No one aims at applying generic measures as substitutes for other more traditional clinical procedures. The whole history of the evolution of these types of measures has been based on comparisons with clinical measures, always seen by researchers as ways to validate health outcome measures and as a process to be recognized by clinicians as a way to detect changes in time not always detected by the usual measures. The measurement instrument presented in this paper is the Portuguese version of the MOS SF-36, originally a result of the Medical Outcomes Study, a study carried out by Rand Corporation researchers in the 80's. One of the objectives of these researchers was precisely to develop instruments to be used in continuous monitoring of outcomes. This paper describes the first time MOS SF-36 was culturally adapted to Portuguese, validated and implemented. The first part mentions some of the foundations and developments of the original instrument as well as some results obtained from some specific applications. The second part introduces operational definitions for each of the eight scales and describes the SF-36 measurement model as well as the factor structure with two dimensions. Next, we present the design used by us to transform the data from the time they are collected from the respondents to the time they are ready to be further used. Finally, the methodology used to culturally adapt the MOS SF-36 and create a Portuguese version which is culturally equivalent are presented.

Measuring adolescents' HRQoL via self reports and parent proxy reports: an evaluation of the psychometric properties of both versions of the KINDL-R instrument.

PubMed

Erhart, Michael; Ellert, Ute; Kurth, Bärbel-Maria; Ravens-Sieberer, Ulrike

2009-08-26

Several instruments are available to assess children's health-related quality of life (HRQoL) based on self reports as well as proxy reports from parents. Previous studies have found only low-to-moderate agreement between self and proxy reports, but few studies have explicitly compared the psychometric qualities of both. This study compares the reliability, factorial validity and convergent and known group validity of the self-report and parent-report versions of the HRQoL KINDL-R questionnaire for children and adolescents. Within the nationally representative cross-sectional German Health Interview and Examination Survey for Children and Adolescents (KiGGS), 6,813 children and adolescents aged 11 to 17 years completed the KINDL-R generic HRQoL instrument while their parents answered the KINDL proxy version (both in paper-and-pencil versions). Cronbach's alpha and confirmatory factor-analysis models (linear structural equation model) were obtained. Convergent and discriminant validity were assessed by calculating the Pearson's correlation coefficient for the Strengths and Difficulties Questionnaire. Known-groups differences were examined (ANOVA) for obese children and children with a lower familial socio-economic status. The parent reports achieved slightly higher Cronbach's alpha values for the total score (0.86 vs. 0.83) and most sub-scores. Confirmatory factor analysis revealed an acceptable fit of the six-dimensional measurement model of the KINDL for the parent (RMSEA=0.07) and child reports (RMSEA=0.06). Factorial invariance across the two versions did not hold with regards to the pattern of loadings, the item errors and the covariation between latent concepts. However the magnitude of the differences was rather small. The parent report version achieved slightly higher convergent validity (r=0.44-0.63 vs. r=0.33-0.59) in the Strengths and Difficulties Questionnaire. No clear differences were observed for known-groups validity. Our study showed that parent proxy reports and child self reports on the child's HRQoL slightly differ with regards to how the perceptions, evaluations and possibly the affective resonance of each group are structured and internally consistent. Overall, the parent reports achieved slightly higher reliability and thus are favoured for the examination of small samples. No version was universally superior with regards to the validity of the measurements. Whenever possible, children's HRQoL should be measured via both sources of information.

"This body does not want free medicines": South African consumer perceptions of drug quality.

PubMed

Patel, Aarti; Gauld, Robin; Norris, Pauline; Rades, Thomas

2010-01-01

OBJECTIVES Like many other developing countries, South Africa provides free medicines through its public health care facilities. Recent policies encourage generic substitution in the private sector. This study explored South African consumer perceptions of drug quality and whether these perceptions influenced how people procured and used their medicines. METHODS The study was undertaken in Durban, Cape Town and Johannesburg in South Africa between December 2005 and January 2006. A combination of purposive and snowball sampling was used to recruit participants from low and middle socio-economic groups as well as the elderly and teenagers. Data were collected through 12 focus group discussions involving a total of 73 participants. Interviews were tape-recorded. Thematic analysis was performed on the transcripts. RESULTS Irrespective of socio-economic status, respondents described medicine quality in terms of the effect the medicine produced on felt symptoms. Generic medicines, as well as medicines supplied without charge by the state, were considered to be poor quality and treated with suspicion. Respondents obtained medicines from three sources: public sector hospitals and/or clinics, dispensing doctors and community pharmacies. Cost, avoidance of feeling 'second-class', receiving individualized care and choice in drug selection were the main determinants influencing their procurement behaviour. Selection of over-the-counter medicines was influenced by prior knowledge of products, through advertising and previous use. Participants perceived that they had limited influence on selection of prescription medicines. Generic substitution would be supported if the doctor, rather than the pharmacist, recommended it. CONCLUSIONS Our findings emphasize the importance of meaningful consumer involvement in the development of national medicines policies, and strategic campaigns targeting consumers and prescribers regarding the quality of generic and essential medicines. Where consumers perceive free or generic medicines as inferior, this could significantly undermine attempts to implement national medicines policies aimed to improve access to medicines.

Application of process mapping to understand integration of high risk medicine care bundles within community pharmacy practice.

PubMed

Weir, Natalie M; Newham, Rosemary; Corcoran, Emma D; Ali Atallah Al-Gethami, Ashwag; Mohammed Abd Alridha, Ali; Bowie, Paul; Watson, Anne; Bennie, Marion

2017-11-21

The Scottish Patient Safety Programme - Pharmacy in Primary Care collaborative is a quality improvement initiative adopting the Institute of Healthcare Improvement Breakthrough Series collaborative approach. The programme developed and piloted High Risk Medicine (HRM) Care Bundles (CB), focused on warfarin and non-steroidal anti-inflammatories (NSAIDs), within 27 community pharmacies over 4 NHS Regions. Each CB involves clinical assessment and patient education, although the CB content varies between regions. To support national implementation, this study aims to understand how the pilot pharmacies integrated the HRM CBs into routine practice to inform the development of a generic HRM CB process map. Regional process maps were developed in 4 pharmacies through simulation of the CB process, staff interviews and documentation of resources. Commonalities were collated to develop a process map for each HRM, which were used to explore variation at a national event. A single, generic process map was developed which underwent validation by case study testing. The findings allowed development of a generic process map applicable to warfarin and NSAID CB implementation. Five steps were identified as required for successful CB delivery: patient identification; clinical assessment; pharmacy CB prompt; CB delivery; and documentation. The generic HRM CB process map encompasses the staff and patients' journey and the CB's integration into routine community pharmacy practice. Pharmacist involvement was required only for clinical assessment, indicating suitability for whole-team involvement. Understanding CB integration into routine practice has positive implications for successful implementation. The generic process map can be used to develop targeted resources, and/or be disseminated to facilitate CB delivery and foster whole team involvement. Similar methods could be utilised within other settings, to allow those developing novel services to distil the key processes and consider their integration within routine workflows to effect maximal, efficient implementation and benefit to patient care. Copyright © 2017 Elsevier Inc. All rights reserved.

Comparison of generic-to-brand switchback patterns for generic and authorized generic drugs

PubMed Central

Hansen, Richard A.; Qian, Jingjing; Berg, Richard; Linneman, James; Seoane-Vazquez, Enrique; Dutcher, Sarah K.; Raofi, Saeid; Page, C. David; Peissig, Peggy

2018-01-01

Background While generic drugs are therapeutically equivalent to brand drugs, some patients and healthcare providers remain uncertain about whether they produce identical outcomes. Authorized generics, which are identical in formulation to corresponding brand drugs but marketed as a generic, provide a unique post-marketing opportunity to study whether utilization patterns are influenced by perceptions of generic drugs. Objectives To compare generic-to-brand switchback rates between generics and authorized generics. Methods A retrospective cohort study was conducted using claims and electronic health records data from a regional U.S. healthcare system. Ten drugs with authorized generics and generics marketed between 1999 and 2014 were evaluated. Eligible adult patients received a brand drug during the 6 months preceding generic entry, and then switched to a generic or authorized generic. Patients in this cohort were followed for up to 30 months from the index switch date to evaluate occurrence of generic-to-brand switchbacks. Switchback rates were compared between patients on authorized generics versus generics using Kaplan-Meier curves and Cox proportional hazards models, controlling for individual drug effects, age, sex, Charlson comorbidity score, pre-index drug use characteristics, and pre-index healthcare utilization. Results Among 5,542 unique patients that switched from brand-to-generic or brand-to-authorized generic, 264 (4.8%) switched back to the brand drug. Overall switchback rates were similar for authorized generics compared with generics (HR=0.86; 95% CI 0.65-1.15). The likelihood of switchback was higher for alendronate (HR=1.64; 95% CI 1.20-2.23) and simvastatin (HR=1.81; 95% CI 1.30-2.54) and lower for amlodipine (HR=0.27; 95% CI 0.17-0.42) compared with other drugs in the cohort. Conclusions Overall switchback rates were similar between authorized generic and generic drug users, indirectly supporting similar efficacy and tolerability profiles for brand and generic drugs. Reasons for differences in switchback rates among specific products need to be further explored. PMID:28152215

Unsupervised learning in persistent sensing for target recognition by wireless ad hoc networks of ground-based sensors

NASA Astrophysics Data System (ADS)

Hortos, William S.

2008-04-01

In previous work by the author, effective persistent and pervasive sensing for recognition and tracking of battlefield targets were seen to be achieved, using intelligent algorithms implemented by distributed mobile agents over a composite system of unmanned aerial vehicles (UAVs) for persistence and a wireless network of unattended ground sensors for pervasive coverage of the mission environment. While simulated performance results for the supervised algorithms of the composite system are shown to provide satisfactory target recognition over relatively brief periods of system operation, this performance can degrade by as much as 50% as target dynamics in the environment evolve beyond the period of system operation in which the training data are representative. To overcome this limitation, this paper applies the distributed approach using mobile agents to the network of ground-based wireless sensors alone, without the UAV subsystem, to provide persistent as well as pervasive sensing for target recognition and tracking. The supervised algorithms used in the earlier work are supplanted by unsupervised routines, including competitive-learning neural networks (CLNNs) and new versions of support vector machines (SVMs) for characterization of an unknown target environment. To capture the same physical phenomena from battlefield targets as the composite system, the suite of ground-based sensors can be expanded to include imaging and video capabilities. The spatial density of deployed sensor nodes is increased to allow more precise ground-based location and tracking of detected targets by active nodes. The "swarm" mobile agents enabling WSN intelligence are organized in a three processing stages: detection, recognition and sustained tracking of ground targets. Features formed from the compressed sensor data are down-selected according to an information-theoretic algorithm that reduces redundancy within the feature set, reducing the dimension of samples used in the target recognition and tracking routines. Target tracking is based on simplified versions of Kalman filtration. Accuracy of recognition and tracking of implemented versions of the proposed suite of unsupervised algorithms is somewhat degraded from the ideal. Target recognition and tracking by supervised routines and by unsupervised SVM and CLNN routines in the ground-based WSN is evaluated in simulations using published system values and sensor data from vehicular targets in ground-surveillance scenarios. Results are compared with previously published performance for the system of the ground-based sensor network (GSN) and UAV swarm.

Application of Smoothing Techniques for Tracking Maneuvering Targets. Multiple Target Tracking in Clutter: New Approaches

DTIC Science & Technology

1992-07-01

target state estimation is affected not only by the measurement noise but also by the uncertainty in the origins of the measurements. To improve the...to identify targets in the presence of anticipated background noise (including earth, lunar, star backgrounds, complicated spacecraft structures...each other. Futhermore, those frames are often degraded versions of the original scene due to blur and noise . Through the task of image registration

An IT Architecture for Systems Medicine.

PubMed

Ganzinger, Matthias; Gietzelt, Matthias; Karmen, Christian; Firnkorn, Daniel; Knaup, Petra

2015-01-01

Systems medicine aims to support treatment of complex diseases like cancer by integrating all available data for the disease. To provide such a decision support in clinical practice, a suitable IT architecture is necessary. We suggest a generic architecture comprised of the following three layers: data representation, decision support, and user interface. For the systems medicine research project "Clinically-applicable, omics-based assessment of survival, side effects, and targets in multiple myeloma" (CLIOMMICS) we developed a concrete instance of the generic architecture. We use i2b2 for representing the harmonized data. Since no deterministic model exists for multiple myeloma we use case-based reasoning for decision support. For clinical practice, visualizations of the results must be intuitive and clear. At the same time, they must communicate the uncertainty immanent in stochastic processes. Thus, we develop a specific user interface for systems medicine based on the web portal software Liferay.

Spontaneous Gender Categorization in Masking and Priming Studies: Key for Distinguishing Jane from John Doe but Not Madonna from Sinatra

PubMed Central

Habibi, Ruth; Khurana, Beena

2012-01-01

Facial recognition is key to social interaction, however with unfamiliar faces only generic information, in the form of facial stereotypes such as gender and age is available. Therefore is generic information more prominent in unfamiliar versus familiar face processing? In order to address the question we tapped into two relatively disparate stages of face processing. At the early stages of encoding, we employed perceptual masking to reveal that only perception of unfamiliar face targets is affected by the gender of the facial masks. At the semantic end; using a priming paradigm, we found that while to-be-ignored unfamiliar faces prime lexical decisions to gender congruent stereotypic words, familiar faces do not. Our findings indicate that gender is a more salient dimension in unfamiliar relative to familiar face processing, both in early perceptual stages as well as later semantic stages of person construal. PMID:22389697

Advances in cognitive theory and therapy: the generic cognitive model.

PubMed

Beck, Aaron T; Haigh, Emily A P

2014-01-01

For over 50 years, Beck's cognitive model has provided an evidence-based way to conceptualize and treat psychological disorders. The generic cognitive model represents a set of common principles that can be applied across the spectrum of psychological disorders. The updated theoretical model provides a framework for addressing significant questions regarding the phenomenology of disorders not explained in previous iterations of the original model. New additions to the theory include continuity of adaptive and maladaptive function, dual information processing, energizing of schemas, and attentional focus. The model includes a theory of modes, an organization of schemas relevant to expectancies, self-evaluations, rules, and memories. A description of the new theoretical model is followed by a presentation of the corresponding applied model, which provides a template for conceptualizing a specific disorder and formulating a case. The focus on beliefs differentiates disorders and provides a target for treatment. A variety of interventions are described.

ROBIN: a platform for evaluating automatic target recognition algorithms: I. Overview of the project and presentation of the SAGEM DS competition

NASA Astrophysics Data System (ADS)

Duclos, D.; Lonnoy, J.; Guillerm, Q.; Jurie, F.; Herbin, S.; D'Angelo, E.

2008-04-01

The last five years have seen a renewal of Automatic Target Recognition applications, mainly because of the latest advances in machine learning techniques. In this context, large collections of image datasets are essential for training algorithms as well as for their evaluation. Indeed, the recent proliferation of recognition algorithms, generally applied to slightly different problems, make their comparisons through clean evaluation campaigns necessary. The ROBIN project tries to fulfil these two needs by putting unclassified datasets, ground truths, competitions and metrics for the evaluation of ATR algorithms at the disposition of the scientific community. The scope of this project includes single and multi-class generic target detection and generic target recognition, in military and security contexts. From our knowledge, it is the first time that a database of this importance (several hundred thousands of visible and infrared hand annotated images) has been publicly released. Funded by the French Ministry of Defence (DGA) and by the French Ministry of Research, ROBIN is one of the ten Techno-vision projects. Techno-vision is a large and ambitious government initiative for building evaluation means for computer vision technologies, for various application contexts. ROBIN's consortium includes major companies and research centres involved in Computer Vision R&D in the field of defence: Bertin Technologies, CNES, ECA, DGA, EADS, INRIA, ONERA, MBDA, SAGEM, THALES. This paper, which first gives an overview of the whole project, is focused on one of ROBIN's key competitions, the SAGEM Defence Security database. This dataset contains more than eight hundred ground and aerial infrared images of six different vehicles in cluttered scenes including distracters. Two different sets of data are available for each target. The first set includes different views of each vehicle at close range in a "simple" background, and can be used to train algorithms. The second set contains many views of the same vehicle in different contexts and situations simulating operational scenarios.

Redefining Information Warfare Boundaries for an Army in a Wireless World

DTIC Science & Technology

2013-01-01

development. For example, such a generic requirement might involve detection, identification, tracking, and kill - ing a class of targets by nonkinetic...Merging Information Operations and Psychological Operations,” Military Review, January–February 2008, pp. 108–111. Rosin, Randolph, “To Kill a... Mockingbird : The Deconstruction of Information Operations,” Small Wars Journal, August 17, 2009. As of December 6, 2010: http://smallwarsjournal.com/blog

Person-specific theory of mind in medial pFC.

PubMed

Welborn, B Locke; Lieberman, Matthew D

2015-01-01

Although research on theory of mind has strongly implicated the dorsomedial pFC (incuding medial BA 8 and BA 9), the unique contributions of medial pFC (MPFC; corresponding to medial BA 10) to mentalizing remain uncertain. The extant literature has considered the possibility that these regions may be specialized for self-related cognition or for reasoning about close others, but evidence for both accounts has been inconclusive. We propose a novel theoretical framework: MPFC selectively implements "person-specific theories of mind" (ToMp) representing the unique, idiosyncratic traits or attributes of well-known individuals. To test this hypothesis, we used fMRI to assess MPFC responses in Democratic and Republican participants as they evaluated more or less subjectively well-known political figures. Consistent with the ToMp account, MPFC showed greater activity to subjectively well-known targets, irrespective of participants' reported feelings of closeness or similarity. MPFC also demonstrated greater activity on trials in which targets (whether politicians or oneself) were judged to be relatively idiosyncratic, making a generic theory of mind inapplicable. These results suggest that MPFC may supplement the generic theory of mind process, with which dorsomedial pFC has been associated, by contributing mentalizing capacities tuned to individuated representations of specific well-known others.

Publisher Correction: The global distribution of tetrapods reveals a need for targeted reptile conservation.

PubMed

Roll, Uri; Feldman, Anat; Novosolov, Maria; Allison, Allen; Bauer, Aaron M; Bernard, Rodolphe; Böhm, Monika; Castro-Herrera, Fernando; Chirio, Laurent; Collen, Ben; Colli, Guarino R; Dabool, Lital; Das, Indraneil; Doan, Tiffany M; Grismer, Lee L; Hoogmoed, Marinus; Itescu, Yuval; Kraus, Fred; LeBreton, Matthew; Lewin, Amir; Martins, Marcio; Maza, Erez; Meirte, Danny; Nagy, Zoltán T; de C Nogueira, Cristiano; Pauwels, Olivier S G; Pincheira-Donoso, Daniel; Powney, Gary D; Sindaco, Roberto; Tallowin, Oliver J S; Torres-Carvajal, Omar; Trape, Jean-François; Vidan, Enav; Uetz, Peter; Wagner, Philipp; Wang, Yuezhao; Orme, C David L; Grenyer, Richard; Meiri, Shai

2017-11-01

In this Article originally published, owing to a technical error, the author 'Laurent Chirio' was mistakenly designated as a corresponding author in the HTML version, the PDF was correct. This error has now been corrected in the HTML version. Further, in Supplementary Table 3, the authors misspelt the surname of 'Danny Meirte'; this file has now been replaced.

Small target detection using objectness and saliency

NASA Astrophysics Data System (ADS)

Zhang, Naiwen; Xiao, Yang; Fang, Zhiwen; Yang, Jian; Wang, Li; Li, Tao

2017-10-01

We are motived by the need for generic object detection algorithm which achieves high recall for small targets in complex scenes with acceptable computational efficiency. We propose a novel object detection algorithm, which has high localization quality with acceptable computational cost. Firstly, we obtain the objectness map as in BING[1] and use NMS to get the top N points. Then, k-means algorithm is used to cluster them into K classes according to their location. We set the center points of the K classes as seed points. For each seed point, an object potential region is extracted. Finally, a fast salient object detection algorithm[2] is applied to the object potential regions to highlight objectlike pixels, and a series of efficient post-processing operations are proposed to locate the targets. Our method runs at 5 FPS on 1000*1000 images, and significantly outperforms previous methods on small targets in cluttered background.

Electro-optic tracking R&D for defense surveillance

NASA Astrophysics Data System (ADS)

Sutherland, Stuart; Woodruff, Chris J.

1995-09-01

Two aspects of work on automatic target detection and tracking for electro-optic (EO) surveillance are described. Firstly, a detection and tracking algorithm test-bed developed by DSTO and running on a PC under Windows NT is being used to assess candidate algorithms for unresolved and minimally resolved target detection. The structure of this test-bed is described and examples are given of its user interfaces and outputs. Secondly, a development by Australian industry under a Defence-funded contract, of a reconfigurable generic track processor (GTP) is outlined. The GTP will include reconfigurable image processing stages and target tracking algorithms. It will be used to demonstrate to the Australian Defence Force automatic detection and tracking capabilities, and to serve as a hardware base for real time algorithm refinement.

Optimization of Adaboost Algorithm for Sonar Target Detection in a Multi-Stage ATR System

NASA Technical Reports Server (NTRS)

Lin, Tsung Han (Hank)

2011-01-01

JPL has developed a multi-stage Automated Target Recognition (ATR) system to locate objects in images. First, input images are preprocessed and sent to a Grayscale Optical Correlator (GOC) filter to identify possible regions-of-interest (ROIs). Second, feature extraction operations are performed using Texton filters and Principal Component Analysis (PCA). Finally, the features are fed to a classifier, to identify ROIs that contain the targets. Previous work used the Feed-forward Back-propagation Neural Network for classification. In this project we investigate a version of Adaboost as a classifier for comparison. The version we used is known as GentleBoost. We used the boosted decision tree as the weak classifier. We have tested our ATR system against real-world sonar images using the Adaboost approach. Results indicate an improvement in performance over a single Neural Network design.

Experimental clean combustor program, phase 1

NASA Technical Reports Server (NTRS)

Bahr, D. W.; Gleason, C. C.

1975-01-01

Full annular versions of advanced combustor designs, sized to fit within the CF6-50 engine, were defined, manufactured, and tested at high pressure conditions. Configurations were screened, and significant reductions in CO, HC, and NOx emissions levels were achieved with two of these advanced combustor design concepts. Emissions and performance data at a typical AST cruise condition were also obtained along with combustor noise data as a part of an addendum to the basic program. The two promising combustor design approaches evolved in these efforts were the Double Annular Combustor and the Radial/Axial Combustor. With versions of these two basic combustor designs, CO and HC emissions levels at or near the target levels were obtained. Although the low target NOx emissions level was not obtained with these two advanced combustor designs, significant reductions were relative to the NOx levels of current technology combustors. Smoke emission levels below the target value were obtained.

Target Assembly to Check Boresight Alignment of Active Sensors

NASA Technical Reports Server (NTRS)

Ramos-Izquierdo, Luis; Scott, V. Stanley; Riris, Haris; Cavanaugh, John; Liiva, Peter; Rodriguez, Michael

2011-01-01

A compact and portable target assembly (Fig. 1) has been developed to measure the boresite alignment of LRO's Lunar Orbiter Laser Altimeter (LOLA) instrument at the spacecraft level. The concept for this target assembly has evolved over many years with earlier versions used to test the Mars Observer Laser Altimeter (MOLA), the Geoscience Laser Altimeter System (GLAS), and the Mercury Laser Altimeter (MLA) space-based instruments.

TARGET - TASK ANALYSIS REPORT GENERATION TOOL, VERSION 1.0

NASA Technical Reports Server (NTRS)

Ortiz, C. J.

1994-01-01

The Task Analysis Report Generation Tool, TARGET, is a graphical interface tool used to capture procedural knowledge and translate that knowledge into a hierarchical report. TARGET is based on VISTA, a knowledge acquisition tool developed by the Naval Systems Training Center. TARGET assists a programmer and/or task expert organize and understand the steps involved in accomplishing a task. The user can label individual steps in the task through a dialogue-box and get immediate graphical feedback for analysis. TARGET users can decompose tasks into basic action kernels or minimal steps to provide a clear picture of all basic actions needed to accomplish a job. This method allows the user to go back and critically examine the overall flow and makeup of the process. The user can switch between graphics (box flow diagrams) and text (task hierarchy) versions to more easily study the process being documented. As the practice of decomposition continues, tasks and their subtasks can be continually modified to more accurately reflect the user's procedures and rationale. This program is designed to help a programmer document an expert's task thus allowing the programmer to build an expert system which can help others perform the task. Flexibility is a key element of the system design and of the knowledge acquisition session. If the expert is not able to find time to work on the knowledge acquisition process with the program developer, the developer and subject matter expert may work in iterative sessions. TARGET is easy to use and is tailored to accommodate users ranging from the novice to the experienced expert systems builder. TARGET is written in C-language for IBM PC series and compatible computers running MS-DOS and Microsoft Windows version 3.0 or 3.1. No source code is supplied. The executable also requires 2Mb of RAM, a Microsoft compatible mouse, a VGA display and an 80286, 386 or 486 processor machine. The standard distribution medium for TARGET is one 5.25 inch 360K MS-DOS format diskette. TARGET was developed in 1991.

Ada Compiler Validation Summary Report: Certificate Number 89020W1. 10073: International Business Machines Corporation, IBM Development System for the Ada Language, VM/CMS Ada Compiler, Version 2.1.1, IBM 3083 (Host and Target)

DTIC Science & Technology

1989-04-20

International Business Machines Corporation) IBM Development System for the Ada Language, VN11/CMS Ada Compiler, Version 2.1.1, Wright-Patterson AFB, IBM 3083...890420W1.10073 International Business Machines Corporation IBM Development System for the Ada Language VM/CMS Ada Compiler Version 2.1.1 IBM 3083... International Business Machines Corporation and reviewed by the validation team. The compiler was tested using all default option settings except for the

Authorized generic drugs, price competition, and consumers' welfare.

PubMed

Berndt, Ernst R; Mortimer, Richard; Bhattacharjya, Ashoke; Parece, Andrew; Tuttle, Edward

2007-01-01

The growing frequency of authorized generics has important implications for the welfare of prescription drug consumers. Authorized generic entry could affect the timing of generic entry, brand-name and generic prices, and generic penetration. We reviewed 1999-2003 data and found that generic entry in the absence of short-run exclusivity restrictions benefits consumers through lower short-run prices. We suggest that these benefits likely also result from authorized generics. We posit that long-run prices and shares are likely essentially unaffected by authorized generics and that potential costs to consumers from any delayed generic entry are likely small.

Multiple-Object Tracking in Children: The "Catch the Spies" Task

ERIC Educational Resources Information Center

Trick, L.M.; Jaspers-Fayer, F.; Sethi, N.

2005-01-01

Multiple-object tracking involves simultaneously tracking positions of a number of target-items as they move among distractors. The standard version of the task poses special challenges for children, demanding extended concentration and the ability to distinguish targets from identical-looking distractors, and may thus underestimate children's…

DIANA-microT web server v5.0: service integration into miRNA functional analysis workflows.

PubMed

Paraskevopoulou, Maria D; Georgakilas, Georgios; Kostoulas, Nikos; Vlachos, Ioannis S; Vergoulis, Thanasis; Reczko, Martin; Filippidis, Christos; Dalamagas, Theodore; Hatzigeorgiou, A G

2013-07-01

MicroRNAs (miRNAs) are small endogenous RNA molecules that regulate gene expression through mRNA degradation and/or translation repression, affecting many biological processes. DIANA-microT web server (http://www.microrna.gr/webServer) is dedicated to miRNA target prediction/functional analysis, and it is being widely used from the scientific community, since its initial launch in 2009. DIANA-microT v5.0, the new version of the microT server, has been significantly enhanced with an improved target prediction algorithm, DIANA-microT-CDS. It has been updated to incorporate miRBase version 18 and Ensembl version 69. The in silico-predicted miRNA-gene interactions in Homo sapiens, Mus musculus, Drosophila melanogaster and Caenorhabditis elegans exceed 11 million in total. The web server was completely redesigned, to host a series of sophisticated workflows, which can be used directly from the on-line web interface, enabling users without the necessary bioinformatics infrastructure to perform advanced multi-step functional miRNA analyses. For instance, one available pipeline performs miRNA target prediction using different thresholds and meta-analysis statistics, followed by pathway enrichment analysis. DIANA-microT web server v5.0 also supports a complete integration with the Taverna Workflow Management System (WMS), using the in-house developed DIANA-Taverna Plug-in. This plug-in provides ready-to-use modules for miRNA target prediction and functional analysis, which can be used to form advanced high-throughput analysis pipelines.

DIANA-microT web server v5.0: service integration into miRNA functional analysis workflows

PubMed Central

Paraskevopoulou, Maria D.; Georgakilas, Georgios; Kostoulas, Nikos; Vlachos, Ioannis S.; Vergoulis, Thanasis; Reczko, Martin; Filippidis, Christos; Dalamagas, Theodore; Hatzigeorgiou, A.G.

2013-01-01

MicroRNAs (miRNAs) are small endogenous RNA molecules that regulate gene expression through mRNA degradation and/or translation repression, affecting many biological processes. DIANA-microT web server (http://www.microrna.gr/webServer) is dedicated to miRNA target prediction/functional analysis, and it is being widely used from the scientific community, since its initial launch in 2009. DIANA-microT v5.0, the new version of the microT server, has been significantly enhanced with an improved target prediction algorithm, DIANA-microT-CDS. It has been updated to incorporate miRBase version 18 and Ensembl version 69. The in silico-predicted miRNA–gene interactions in Homo sapiens, Mus musculus, Drosophila melanogaster and Caenorhabditis elegans exceed 11 million in total. The web server was completely redesigned, to host a series of sophisticated workflows, which can be used directly from the on-line web interface, enabling users without the necessary bioinformatics infrastructure to perform advanced multi-step functional miRNA analyses. For instance, one available pipeline performs miRNA target prediction using different thresholds and meta-analysis statistics, followed by pathway enrichment analysis. DIANA-microT web server v5.0 also supports a complete integration with the Taverna Workflow Management System (WMS), using the in-house developed DIANA-Taverna Plug-in. This plug-in provides ready-to-use modules for miRNA target prediction and functional analysis, which can be used to form advanced high-throughput analysis pipelines. PMID:23680784

Telescience Resource Kit (TReK)

NASA Technical Reports Server (NTRS)

Lippincott, Jeff

2015-01-01

Telescience Resource Kit (TReK) is one of the Huntsville Operations Support Center (HOSC) remote operations solutions. It can be used to monitor and control International Space Station (ISS) payloads from anywhere in the world. It is comprised of a suite of software applications and libraries that provide generic data system capabilities and access to HOSC services. The TReK Software has been operational since 2000. A new cross-platform version of TReK is under development. The new software is being released in phases during the 2014-2016 timeframe. The TReK Release 3.x series of software is the original TReK software that has been operational since 2000. This software runs on Windows. It contains capabilities to support traditional telemetry and commanding using CCSDS (Consultative Committee for Space Data Systems) packets. The TReK Release 4.x series of software is the new cross platform software. It runs on Windows and Linux. The new TReK software will support communication using standard IP protocols and traditional telemetry and commanding. All the software listed above is compatible and can be installed and run together on Windows. The new TReK software contains a suite of software that can be used by payload developers on the ground and onboard (TReK Toolkit). TReK Toolkit is a suite of lightweight libraries and utility applications for use onboard and on the ground. TReK Desktop is the full suite of TReK software -most useful on the ground. When TReK Desktop is released, the TReK installation program will provide the option to choose just the TReK Toolkit portion of the software or the full TReK Desktop suite. The ISS program is providing the TReK Toolkit software as a generic flight software capability offered as a standard service to payloads. TReK Software Verification was conducted during the April/May 2015 timeframe. Payload teams using the TReK software onboard can reference the TReK software verification. TReK will be demonstrated on-orbit running on an ISS provided T61p laptop. Target Timeframe: September 2015 -2016. The on-orbit demonstration will collect benchmark metrics, and will be used in the future to provide live demonstrations during ISS Payload Conferences. Benchmark metrics and demonstrations will address the protocols described in SSP 52050-0047 Ku Forward section 3.3.7. (Associated term: CCSDS File Delivery Protocol (CFDP)).

Patient-reported outcome measures for systemic lupus erythematosus clinical trials: a review of content validity, face validity and psychometric performance.

PubMed

Holloway, Laura; Humphrey, Louise; Heron, Louise; Pilling, Claire; Kitchen, Helen; Højbjerre, Lise; Strandberg-Larsen, Martin; Hansen, Brian Bekker

2014-07-22

Despite overall progress in treatment of autoimmune diseases, patients with systemic lupus erythematosus (SLE) experience many inflammatory symptoms representing an unmet medical need. This study aimed to create a conceptual model of the humanistic and economic burden of SLE, and review the patient-reported outcomes (PROs) used to measure such concepts in SLE clinical trials. A conceptual model for SLE was developed from structured review of published articles from 2007 to August 2013 identified from literature databases (MEDLINE, EMBASE, PsycINFO, EconLit) plus other sources (PROLabels, FDA/EMA websites, Clinicaltrials.gov). PROs targeting key symptoms/impacts were identified from the literature. They were reviewed in the context of available guidance and assessed for face and content validity and psychometric properties to determine appropriateness for use in SLE trials. The conceptual model identified fatigue, pain, cognition, daily activities, emotional well-being, physical/social functioning and work productivity as key SLE concepts. Of the 68 articles reviewed, 38 reported PRO data. From these and the other sources, 15 PROs were selected for review, including SLE-specific health-related quality of life (HRQoL) measures (n = 5), work productivity (n = 1), and generic measures of fatigue (n = 3), pain (n = 2), depression (n = 2) and HRQoL (n = 2). The Functional Assessment of Chronic Illness Therapy - Fatigue Scale (FACIT-Fatigue), Brief Pain Inventory (BPI-SF) and LupusQoL demonstrated the strongest face validity, conceptual coverage and psychometric properties measuring key concepts in the conceptual model. All PROs reviewed, except for three Lupus-specific measures, lacked qualitative SLE patient involvement during development. The Hospital Anxiety and Depression Scale (HADS), Short Form [36 item] Health Survey version 2 (SF-36v2), EuroQoL 5-dimensions (EQ-5D-3L and EQ-5D-5L) and Work Productivity and Activity Impairment Questionnaire: Lupus (WPAI:Lupus) showed suitability for SLE economic models. Based on the identification of key symptoms and impacts of SLE using a scientifically sound conceptual model, we conclude that SLE is a condition associated with high unmet need and considerable burden to patients. This review highlights the availability and need for disease-specific and generic patient-reported measures of relevant domains of disease signs and symptoms, HRQoL and work productivity, providing useful insight for SLE clinical trial design.

The experiences of implementing generic medicine policy in eight countries: A review and recommendations for a successful promotion of generic medicine use

PubMed Central

Hassali, Mohamed Azmi; Alrasheedy, Alian A.; McLachlan, Andrew; Nguyen, Tuan Anh; AL-Tamimi, Saleh Karamah; Ibrahim, Mohamed Izham Mohamed; Aljadhey, Hisham

2013-01-01

Generic medicines are clinically interchangeable with original brand medicines and have the same quality, efficacy and safety profiles. They are, nevertheless, much cheaper in price. Thus, while providing the same therapeutic outcomes, generic medicines lead to substantial savings for healthcare systems. Therefore, the quality use of generic medicines is promoted in many countries. In this paper, we reviewed the role of generic medicines in healthcare systems and the experiences of promoting the use of generic medicines in eight selected countries, namely the United States (US), the United Kingdom (UK), Sweden, Finland, Australia, Japan, Malaysia and Thailand. The review showed that there are different main policies adopted to promote generic medicines such as generic substitution in the US, generic prescribing in the UK and mandatory generic substitution in Sweden and Finland. To effectively and successfully implement the main policy, different complementary policies and initiatives were necessarily introduced. Barriers to generic medicine use varied between countries from negative perceptions about generic medicines to lack of a coherent generic medicine policy, while facilitators included availability of information about generic medicines to both healthcare professionals and patients, brand interchangeability guidelines, regulations that support generic substitution by pharmacists, and incentives to both healthcare professionals and patients. PMID:25561861

Noninvasive fetal QRS detection using an echo state network and dynamic programming.

PubMed

Lukoševičius, Mantas; Marozas, Vaidotas

2014-08-01

We address a classical fetal QRS detection problem from abdominal ECG recordings with a data-driven statistical machine learning approach. Our goal is to have a powerful, yet conceptually clean, solution. There are two novel key components at the heart of our approach: an echo state recurrent neural network that is trained to indicate fetal QRS complexes, and several increasingly sophisticated versions of statistics-based dynamic programming algorithms, which are derived from and rooted in probability theory. We also employ a standard technique for preprocessing and removing maternal ECG complexes from the signals, but do not take this as the main focus of this work. The proposed approach is quite generic and can be extended to other types of signals and annotations. Open-source code is provided.

A posteriori operation detection in evolving software models

PubMed Central

Langer, Philip; Wimmer, Manuel; Brosch, Petra; Herrmannsdörfer, Markus; Seidl, Martina; Wieland, Konrad; Kappel, Gerti

2013-01-01

As every software artifact, also software models are subject to continuous evolution. The operations applied between two successive versions of a model are crucial for understanding its evolution. Generic approaches for detecting operations a posteriori identify atomic operations, but neglect composite operations, such as refactorings, which leads to cluttered difference reports. To tackle this limitation, we present an orthogonal extension of existing atomic operation detection approaches for detecting also composite operations. Our approach searches for occurrences of composite operations within a set of detected atomic operations in a post-processing manner. One major benefit is the reuse of specifications available for executing composite operations also for detecting applications of them. We evaluate the accuracy of the approach in a real-world case study and investigate the scalability of our implementation in an experiment. PMID:23471366

India's pharmaceutical industry: hype or high tech take-off?

PubMed

Malhotra, Prabodh; Lofgren, Hans

2004-11-08

India has built a large pharmaceutical industry through an array of measures in support of domestic firms. The absence of product patents enabled Indian companies to become world leading producers of generic versions of patented drugs. Low costs and a strong engineering tradition continue to sustain competitive strength. The implementation of the World Trade Organization patent regime in 2005 is driving a transformation of the industry. Key elements of the present shake-up include the return of 'big pharma' companies on a large scale and the emergence of several Indian firms that aim to become fully-fledged research-based multinationals. This article provides a description of the development and structure of the Indian pharmaceutical industry and explores questions and challenges arising from its integration into global markets.

A General Fluctuation-Response Relation for Noise Variations and its Application to Driven Hydrodynamic Experiments

NASA Astrophysics Data System (ADS)

Yolcu, Cem; Bérut, Antoine; Falasco, Gianmaria; Petrosyan, Artyom; Ciliberto, Sergio; Baiesi, Marco

2017-04-01

The effect of a change of noise amplitudes in overdamped diffusive systems is linked to their unperturbed behavior by means of a nonequilibrium fluctuation-response relation. This formula holds also for systems with state-independent nontrivial diffusivity matrices, as we show with an application to an experiment of two trapped and hydrodynamically coupled colloids, one of which is subject to an external random forcing that mimics an effective temperature. The nonequilibrium susceptibility of the energy to a variation of this driving is an example of our formulation, which improves an earlier version, as it does not depend on the time-discretization of the stochastic dynamics. This scheme holds for generic systems with additive noise and can be easily implemented numerically, thanks to matrix operations.

A user-friendly means to scale from the biochemistry of photosynthesis to whole crop canopies and production in time and space - development of Java WIMOVAC.

PubMed

Song, Qingfeng; Chen, Dairui; Long, Stephen P; Zhu, Xin-Guang

2017-01-01

Windows Intuitive Model of Vegetation response to Atmosphere and Climate Change (WIMOVAC) has been used widely as a generic modular mechanistically rich model of plant production. It can predict the responses of leaf and canopy carbon balance, as well as production in different environmental conditions, in particular those relevant to global change. Here, we introduce an open source Java user-friendly version of WIMOVAC. This software is platform independent and can be easily downloaded to a laptop and used without any prior programming skills. In this article, we describe the structure, equations and user guide and illustrate some potential applications of WIMOVAC. © 2016 The Authors Plant, Cell & Environment Published by John Wiley & Sons Ltd.

A generalized approach to complex networks

NASA Astrophysics Data System (ADS)

Costa, L. Da F.; da Rocha, L. E. C.

2006-03-01

This work describes how the formalization of complex network concepts in terms of discrete mathematics, especially mathematical morphology, allows a series of generalizations and important results ranging from new measurements of the network topology to new network growth models. First, the concepts of node degree and clustering coefficient are extended in order to characterize not only specific nodes, but any generic subnetwork. Second, the consideration of distance transform and rings are used to further extend those concepts in order to obtain a signature, instead of a single scalar measurement, ranging from the single node to whole graph scales. The enhanced discriminative potential of such extended measurements is illustrated with respect to the identification of correspondence between nodes in two complex networks, namely a protein-protein interaction network and a perturbed version of it.

Expanded Guidance for NASA Systems Engineering. Volume 1: Systems Engineering Practices

NASA Technical Reports Server (NTRS)

Hirshorn, Steven R.

2016-01-01

This document is intended to provide general guidance and information on systems engineering that will be useful to the NASA community. It provides a generic description of Systems Engineering (SE) as it should be applied throughout NASA. A goal of the expanded guidance is to increase awareness and consistency across the Agency and advance the practice of SE. This guidance provides perspectives relevant to NASA and data particular to NASA. This expanded guidance should be used as a companion for implementing NPR 7123.1, Systems Engineering Processes and Requirements, the Rev 2 version of SP-6105, and the Center-specific handbooks and directives developed for implementing systems engineering at NASA. It provides a companion reference book for the various systems engineering-related training being offered under NASA's auspices.

AQUATOOL, a generalized decision-support system for water-resources planning and operational management

NASA Astrophysics Data System (ADS)

Andreu, J.; Capilla, J.; Sanchís, E.

1996-04-01

This paper describes a generic decision-support system (DSS) which was originally designed for the planning stage of dicision-making associated with complex river basins. Subsequently, it was expanded to incorporate modules relating to the operational stage of decision-making. Computer-assisted design modules allow any complex water-resource system to be represented in graphical form, giving access to geographically referenced databases and knowledge bases. The modelling capability includes basin simulation and optimization modules, an aquifer flow modelling module and two modules for risk assessment. The Segura and Tagus river basins have been used as case studies in the development and validation phases. The value of this DSS is demonstrated by the fact that both River Basin Agencies currently use a version for the efficient management of their water resources.

Generic medicines and generic substitution: contrasting perspectives of stakeholders in Ireland.

PubMed

O'Leary, A; Usher, C; Lynch, M; Hall, M; Hemeryk, L; Spillane, S; Gallagher, P; Barry, M

2015-12-15

The Health (Pricing and Supply of Medical Goods) Act 2013 passed into law in July 2013 and legislated for generic substitution in Ireland. The aim of the study was to ascertain the knowledge and perceptions of stakeholders i.e. patients, pharmacists and prescribers, of generic medicines and to generic substitution with the passing of legislation. Three stakeholder specific questionnaires were developed to assess knowledge of and perceptions to generic medicines and generic substitution. Purposive samples of patients, prescribers and pharmacists were analysed. Descriptive quantitative and qualitative analyses were undertaken. A total of 762 healthcare professionals and 353 patients were recruited. The study highlighted that over 84% of patients were familiar with generic medicines and are supportive of the concept of generic substitution. Approximately 74% of prescribers and 84% of pharmacists were supportive of generic substitution in most cases. The main areas of concern highlighted by the healthcare professionals that might impact on the successful implementation of the policy, were the issue of bioequivalence with generic medicines, the computer software systems used at present in general practitioner (GP) surgeries and the availability of branded generics. The findings from this study identify a high baseline rate of acceptance to generic medicines and generic substitution among patients, prescribers and pharmacists in the Irish setting. The concerns of the main stakeholders provide a valuable insight into the potential difficulties that may arise in its implementation, and the need for on-going reassurance and proactive dissemination of the impact of the generic substitution policy. The existing positive attitude to generic medicines and generic substitution among key stakeholders in Ireland to generic substitution, combined with appropriate support and collaboration should result in the desired increase in rates of prescribing, dispensing and use of generic medicines.

Is there a relationship between patient beliefs or communication about generic drugs and medication utilization?

PubMed

Shrank, William H; Cadarette, Suzanne M; Cox, Emily; Fischer, Michael A; Mehta, Jyotsna; Brookhart, Alan M; Avorn, Jerry; Choudhry, Niteesh K

2009-03-01

Insurers and policymakers strive to stimulate more cost-effective prescribing and, increasingly, are educating beneficiaries about generics. To evaluate the relationship between patient beliefs and communication about generic drugs and actual drug use. We performed a national mailed survey of a random sample of 2500 commercially-insured adults. Patient responses were linked to pharmacy claims data to assess actual generic medication use. We used factor analysis to develop 5 multi-item scales from patient survey responses that measured: (1) general preferences for generics, (2) generic safety/effectiveness, (3) generic cost/value, (4) comfort with generic substitution, and (5) communication with providers about generics. The relationship between each scale and the proportion of prescriptions filled for generics was assessed using linear regression, controlling for demographic, health, and insurance characteristics. Separate models were created for each scale and then all 5 scales were included simultaneously in a fully-adjusted model. The usable response rate was 48%. When evaluated independently, a 1 SD increase in each of the 5 scales was associated with a 3.1% to 6.3% increase in generic drug use (P < 0.05 for each). In the fully adjusted model, only 2 scales were significantly associated with generic drug use: comfort with generic substitution (P = 0.021) and communication with providers about generic drugs (P = 0.012). Generic drug use is most closely associated with the 2 actionable items we evaluated: communication with providers about generics and comfort with generic substitution. Educational campaigns that focus on these 2 domains may be most effective at influencing generic drug use.

Projected savings through public health voluntary licences of HIV drugs negotiated by the Medicines Patent Pool (MPP)

PubMed Central

Juneja, Sandeep; Gupta, Aastha; Moon, Suerie; Resch, Stephen

2017-01-01

The Medicines Patent Pool (MPP) was established in 2010 to ensure timely access to low-cost generic versions of patented antiretroviral (ARV) medicines in low- and middle-income countries (LMICs) through the negotiation of voluntary licences with patent holders. While robust data on the savings generated by MPP and other major global public health initiatives is important, it is also difficult to quantify. In this study, we estimate the savings generated by licences negotiated by the MPP for ARV medicines to treat HIV/AIDS in LMICs for the period 2010–2028 and generate a cost-benefit ratio–based on people living with HIV (PLHIVs) in any new countries which gain access to an ARV due to MPP licences and the price differential between originator’s tiered price and generics price, within the period where that ARV is patented. We found that the direct savings generated by the MPP are estimated to be USD 2.3 billion (net present value) by 2028, representing an estimated cost-benefit ratio of 1:43, which means for every USD 1 spent on MPP, the global public health community saves USD 43. The saving of USD 2.3 billion is equivalent to more than 24 million PLHIV receiving first-line ART in LMICs for 1 year at average prices today. PMID:28542239

Problems with numerical techniques: Application to mid-loop operation transients

DOE Office of Scientific and Technical Information (OSTI.GOV)

Bryce, W.M.; Lillington, J.N.

1997-07-01

There has been an increasing need to consider accidents at shutdown which have been shown in some PSAs to provide a significant contribution to overall risk. In the UK experience has been gained at three levels: (1) Assessment of codes against experiments; (2) Plant studies specifically for Sizewell B; and (3) Detailed review of modelling to support the plant studies for Sizewell B. The work has largely been carried out using various versions of RELAP5 and SCDAP/RELAP5. The paper details some of the problems that have needed to be addressed. It is believed by the authors that these kinds ofmore » problems are probably generic to most of the present generation system thermal-hydraulic codes for the conditions present in mid-loop transients. Thus as far as possible these problems and solutions are proposed in generic terms. The areas addressed include: condensables at low pressure, poor time step calculation detection, water packing, inadequate physical modelling, numerical heat transfer and mass errors. In general single code modifications have been proposed to solve the problems. These have been very much concerned with means of improving existing models rather than by formulating a completely new approach. They have been produced after a particular problem has arisen. Thus, and this has been borne out in practice, the danger is that when new transients are attempted, new problems arise which then also require patching.« less

A waveform detector that targets template–decorrelated signals and achieves its predicted performance, Part I: Demonstration with IMS data

DOE PAGES

Carmichael, Joshua Daniel

2016-01-01

Here, waveform correlation detectors used in seismic monitoring scan multichannel data to test two competing hypotheses: that data contain (1) a noisy, amplitude-scaled version of a template waveform, or, (2) only noise. In reality, seismic wavefields include signals triggered by non-target sources (background seismicity) and targets signals that are only partially correlated with the waveform template.

Information technology security system engineering methodology

NASA Technical Reports Server (NTRS)

Childs, D.

2003-01-01

A methodology is described for system engineering security into large information technology systems under development. The methodology is an integration of a risk management process and a generic system development life cycle process. The methodology is to be used by Security System Engineers to effectively engineer and integrate information technology security into a target system as it progresses through the development life cycle. The methodology can also be used to re-engineer security into a legacy system.

DOE Office of Scientific and Technical Information (OSTI.GOV)

Hichwa, B.P.; Pun, D.D.; Wang, D.

A multielemental analysis to determine the trace metal content of generic and name-brand aspirins and name-brand lipsticks was done via proton induced x-ray (PIXE) measurements. The Hope College PIXE system is described as well as the target preparation methods. The trace metal content of twelve brands of aspirin and aspirin substitutes and fourteen brands of lipstick are reported. Detection limits for most elements are in the range of 100 parts per billion (ppb) to 10 parts per million (ppm).

A Generic and Target Architecture For Command and Control Information Systems

DTIC Science & Technology

1991-09-01

forces, logistics, and optimum routing of forces to destination; supports development of the force, material and personnel 9 lists, schedules , and...recommendations T.5, T.6, and T.73 for Telefax. Teletex, Textfax, and Telefax are not currently scheduled to become a part of GOSIP. In the 1995-1997 time...defining application interfaces to the func- tional areas that impact resource management, for example, priority scheduling , real-time files, and

Generic and sequence-variant specific molecular assays for the detection of the highly variable Grapevine leafroll-associated virus 3.

PubMed

Chooi, Kar Mun; Cohen, Daniel; Pearson, Michael N

2013-04-01

Grapevine leafroll-associated virus 3 (GLRaV-3) is an economically important virus, which is found in all grapevine growing regions worldwide. Its accurate detection in nursery and field samples is of high importance for certification schemes and disease management programmes. To reduce false negatives that can be caused by sequence variability, a new universal primer pair was designed against a divergent sequence data set, targeting the open reading frame 4 (heat shock protein 70 homologue gene), and optimised for conventional one-step RT-PCR and one-step SYBR Green real-time RT-PCR assays. In addition, primer pairs for the simultaneous detection of specific GLRaV-3 variants from groups 1, 2, 6 (specifically NZ-1) and the outlier NZ2 variant, and the generic detection of variants from groups 1 to 5 were designed and optimised as a conventional one-step multiplex RT-PCR assay using the plant nad5 gene as an internal control (i.e. one-step hexaplex RT-PCR). Results showed that the generic and variant specific assays detected in vitro RNA transcripts from a range of 1×10(1)-1×10(8) copies of amplicon per μl diluted in healthy total RNA from Vitis vinifera cv. Cabernet Sauvignon. Furthermore, the assays were employed effectively to screen 157 germplasm and 159 commercial field samples. Thus results demonstrate that the GLRaV-3 generic and variant-specific assays are prospective tools that will be beneficial for certification schemes and disease management programmes, as well as biological and epidemiological studies of the divergent GLRaV-3 populations. Copyright © 2013 Elsevier B.V. All rights reserved.

The validity and reliability of a Spanish version of the summary of diabetes self-care activities questionnaire.

PubMed

Vincent, Deborah; McEwen, Marylyn M; Pasvogel, Alice

2008-01-01

Translation of data collection instruments, paying careful attention to equivalency between the source and the target language, is important to obtain valid data collection instruments. To translate the Summary of Diabetes Self-Care Activities (SDSCA) questionnaire (English) into Spanish and to evaluate the reliability and validity of the Spanish version. Translation and back-translation were used to develop the Spanish version of the SDSCA. The Spanish version of the SDSCA was reviewed by an expert panel for conceptual and content equivalence to the English version. Psychometric properties were assessed further by combining data from three studies that used the Spanish version as a data collection instrument. Correlation of each item of the Spanish and English version of the SDSCA instrument ranged from .78 to 1.00, with no variability in the responses of 2 of the 12 items. Test-retest correlations for the SDSCA ranged from .51 to 1.00. Internal consistency (Cronbach's alpha) for the Spanish version was .68. Items loaded on three factors, with the factors accounting for 61% of the variance in SDSCA. The findings for the psychometric properties of the Spanish version of the SDSCA questionnaire suggest that it has conceptual and content equivalency with the original English version and is valid and reliable. However, further testing with larger samples is required.

Association of authorized generic marketing with prescription drug spending on antidepressants from 2000 to 2011.

PubMed

Cheng, Ning; Banerjee, Tannista; Qian, Jingjing; Hansen, Richard A

Prior research suggests that authorized generic drugs increase competition and decrease prices, but little empirical evidence supports this conclusion. This study evaluated the impact of authorized generic marketing on brand and generic prices. Longitudinal analysis of the household component of the Medical Expenditure Panel Survey. Interview panels over 12 years, with a new panel each year. For each panel, 5 rounds of household interviews were conducted over 30 months. Nationally representative sample of the U.S. civilian noninstitutionalized population, focusing on people using 1 of 5 antidepressant drugs that became generically available between 2000 to 2011. Drugs and dose/formulations with versus without an authorized generic drug marketed. Multiple linear regression models with lagged variables evaluated the effect of an authorized generic on average inflation-adjusted brand and generic price, adjusting for payment sources, generic entry time, competitor price, and year. During 2000-2011, annual brand antidepressant utilization decreased from 51.47 to 7.52 million prescriptions, and generic antidepressant utilization increased from 0 to 88.83 million prescriptions. Over time, payment per prescription for brand prescriptions increased 25% overall, and generic payments decreased 70% for all payer types. With unadjusted data, after generic entry the average brand price decreased $0.59 per year with and $3.62 per year without an authorized generic in the market. Average generic prices decreased $10.30 per year with and $8.47 per year without an authorized generic in the market. In multiple regression models with lagged variables adjusted for heteroscedasticity, payer source, time since generic entry, competitor price, and year, authorized generics significantly reduced average payment for generic (-$3.03) and brand (-$60.64) prescriptions, and over time this price change slowly diminished. Availability of an authorized generic was associated with reduced average generic and brand price in the antidepressant market, supporting prior evidences. Copyright © 2017 American Pharmacists Association®. Published by Elsevier Inc. All rights reserved.

Contextual Cueing in Multiconjunction Visual Search Is Dependent on Color- and Configuration-Based Intertrial Contingencies

ERIC Educational Resources Information Center

Geyer, Thomas; Shi, Zhuanghua; Muller, Hermann J.

2010-01-01

Three experiments examined memory-based guidance of visual search using a modified version of the contextual-cueing paradigm (Jiang & Chun, 2001). The target, if present, was a conjunction of color and orientation, with target (and distractor) features randomly varying across trials (multiconjunction search). Under these conditions, reaction times…