Knowledge, attitudes and practices of community pharmacists on generic medicines in Palestine: a cross-sectional study.

PubMed

Shraim, Naser Y; Al Taha, Tasneem A; Qawasmeh, Rawan F; Jarrar, Hiba N; Shtaya, Maram A N; Shayeb, Lama A; Sweileh, Waleed M

2017-12-28

Generic substitution in several countries has become a common practice. Besides, it is considered as a major cost minimizing strategy meant to contain pharmaceutical expenditure without compromising healthcare quality. However, the safety and quality issues of generic products are of top concerns of general practitioners and health work professionals. This study aimed to investigate community pharmacist's knowledge, attitudes and practices toward generic medicines in Palestine. This study was a cross-sectional observational study employing a self-administered questionnaire. The questionnaire was of four main sections: demographic and practice details of the participants, knowledge, attitudes and the influencing factors related to selection and dispensing of generic medicines. A convenience sampling technique was implemented in this study in which the data collection form was distributed in West Bank- Palestine among a set of practicing pharmacists. Mann-Whitney-U or Kruskal-Wallis tests were used to comparison of different issues as appropriate. P-values of <0.05 were considered significant. A total of 302 community pharmacists were interviewed, slightly more than half were males (52.3%). The mean knowledge score of participants regarding generic medicines was (5.91 ± 1.27) where the highest score was 8 of 10. Knowledge score was not significantly influenced by any of the socio-demographic characteristics. Our data showed that most of included pharmacists in the study (95.4%) agreed that health authorities should implement bioequivalence policies prior to marketing approval of generics, while 87.4% of participants agreed that they should be given the right to substitute generics and the majority (62.3%) support generic substitution for brand name drugs in all cases when a generic is available The main two factors affect pharmacists' selection and dispensing of generic medicines are personal faith in the product (86.1%) and cost effectiveness of generic medicines (84.1%). Generic medicines substitution among pharmacists is widespread and prevalent. Our data found that participant pharmacists in Palestine had basic knowledge with regards to generic medicine. However, their knowledge score pertaining the technical and regulatory aspects of bioequivalence and pharmacokinetic parameters in particular was insufficient.

Parenting style impacts on quality of life in children with cerebral palsy.

PubMed

Aran, Adi; Shalev, Ruth S; Biran, Gali; Gross-Tsur, Varda

2007-07-01

To assess the impact of parenting style and disease severity on quality of life (QOL) in children with cerebral palsy (CP). Thirty-nine children with CP, their siblings, and their parents participated in the study. Probands and siblings, ages 6 to 18 years, completed questionnaires on parenting style (accepting, rejecting, controlling, and autonomy allowing) using the Children's Report of Parental Behavior Inventory. Parents completed generic (Child Health Questionnaire [CHQ]) and disease-specific (Pediatric Outcomes Data Collecting Instrument [PODCI]) QOL questionnaires for both children. A physician determined disease severity with the Gross Motor Function Classification System. In children with CP, parenting style positively correlated with the CHQ scores: physical summary and psychosocial summary (r = 0.40, P = .01) and family activities scale (r = 0.34, P = .03). Autonomy allowing parenting style impacted on psychosocial aspects of QOL, as reflected by CHQ scores, more than the degree of disability. In other domains of QOL, the effect of parenting style was greater than IQ, anxiety, and socioeconomic status. Parenting style is a significant factor in QOL in CP and the only known factor to impact on the psychosocial domains of the CHQ, exceeding the effect of disease severity. Because QOL is an important treatment goal in children with CP, early family interventions, particularly those focusing on parenting style, should be considered.

A GIS-based generic real-time risk assessment framework and decision tools for chemical spills in the river basin.

PubMed

Jiang, Jiping; Wang, Peng; Lung, Wu-seng; Guo, Liang; Li, Mei

2012-08-15

This paper presents a generic framework and decision tools of real-time risk assessment on Emergency Environmental Decision Support System for response to chemical spills in river basin. The generic "4-step-3-model" framework is able to delineate the warning area and the impact on vulnerable receptors considering four types of hazards referring to functional area, societal impact, and human health and ecology system. Decision tools including the stand-alone system and software components were implemented on GIS platform. A detailed case study on the Songhua River nitrobenzene spill illustrated the goodness of the framework and tool Spill first responders and decision makers of catchment management will benefit from the rich, visual and dynamic hazard information output from the software. Copyright © 2012 Elsevier B.V. All rights reserved.

Measuring health-related quality of life in population-based studies of coronary heart disease: comparing six generic indexes and a disease-specific proxy score.

PubMed

Garster, Noelle C; Palta, Mari; Sweitzer, Nancy K; Kaplan, Robert M; Fryback, Dennis G

2009-11-01

To compare HRQoL differences with CHD in generic indexes and a proxy CVD-specific score in a nationally representative sample of U.S. adults. The National Health Measurement Study, a cross-sectional random-digit-dialed telephone survey of adults aged 35-89, administered the EQ-5D, QWB-SA, HUI2, HUI3, SF-36v2 (yielding PCS, MCS, and SF-6D), and HALex. Analyses compared 3,350 without CHD (group 1), 265 with CHD not taking chest pain medication (group 2), and 218 with CHD currently taking chest pain medication (group 3), with and without adjustment for demographic variables and comorbidities. Data on 154 patients from heart failure clinics were used to construct a proxy score utilizing generic items probing CVD symptoms. Mean scores differed between CHD groups for all indexes with and without adjustment (P < 0.0001 for all except MCS P = 0.018). Unadjusted group 3 versus 1 differences were about three times larger than for group 2 versus 1. Standardized differences for the proxy score were similar to those for generic indexes, and were about 1.0 for all except MCS for group 3 versus 1. Generic indexes capture differences in HRQoL in population-based studies of CHD similarly to a score constructed from questions probing CVD-specific symptoms.

Applications of computerized adaptive testing (CAT) to the assessment of headache impact.

PubMed

Ware, John E; Kosinski, Mark; Bjorner, Jakob B; Bayliss, Martha S; Batenhorst, Alice; Dahlöf, Carl G H; Tepper, Stewart; Dowson, Andrew

2003-12-01

To evaluate the feasibility of computerized adaptive testing (CAT) and the reliability and validity of CAT-based estimates of headache impact scores in comparison with 'static' surveys. Responses to the 54-item Headache Impact Test (HIT) were re-analyzed for recent headache sufferers (n = 1016) who completed telephone interviews during the National Survey of Headache Impact (NSHI). Item response theory (IRT) calibrations and the computerized dynamic health assessment (DYNHA) software were used to simulate CAT assessments by selecting the most informative items for each person and estimating impact scores according to pre-set precision standards (CAT-HIT). Results were compared with IRT estimates based on all items (total-HIT), computerized 6-item dynamic estimates (CAT-HIT-6), and a developmental version of a 'static' 6-item form (HIT-6-D). Analyses focused on: respondent burden (survey length and administration time), score distributions ('ceiling' and 'floor' effects), reliability and standard errors, and clinical validity (diagnosis, level of severity). A random sample (n = 245) was re-assessed to test responsiveness. A second study (n = 1103) compared actual CAT surveys and an improved 'static' HIT-6 among current headache sufferers sampled on the Internet. Respondents completed measures from the first study and the generic SF-8 Health Survey; some (n = 540) were re-tested on the Internet after 2 weeks. In the first study, simulated CAT-HIT and total-HIT scores were highly correlated (r = 0.92) without 'ceiling' or 'floor' effects and with a substantial reduction (90.8%) in respondent burden. Six of the 54 items accounted for the great majority of item administrations (3603/5028, 77.6%). CAT-HIT reliability estimates were very high (0.975-0.992) in the range where 95% of respondents scored, and relative validity (RV) coefficients were high for diagnosis (RV = 0.87) and severity (RV = 0.89); patient-level classifications were accurate 91.3% for a diagnosis of migraine. For all three criteria of change, CAT-HIT scores were more responsive than all other measures. In the second study, estimates of respondent burden, item usage, reliability and clinical validity were replicated. The test-retest reliability of CAT-HIT was 0.79 and alternate forms coefficients ranged from 0.85 to 0.91. All correlations with the generic SF-8 were negative. CAT-based administrations of headache impact items achieved very large reductions in respondent burden without compromising validity for purposes of patient screening or monitoring changes in headache impact over time. IRT models and CAT-based dynamic health assessments warrant testing among patients with other conditions.

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.

A method to improve the nutritional quality of foods and beverages based on dietary recommendations.

PubMed

Nijman, C A J; Zijp, I M; Sierksma, A; Roodenburg, A J C; Leenen, R; van den Kerkhoff, C; Weststrate, J A; Meijer, G W

2007-04-01

The increasing consumer interest in health prompted Unilever to develop a globally applicable method (Nutrition Score) to evaluate and improve the nutritional composition of its foods and beverages portfolio. Based on (inter)national dietary recommendations, generic benchmarks were developed to evaluate foods and beverages on their content of trans fatty acids, saturated fatty acids, sodium and sugars. High intakes of these key nutrients are associated with undesirable health effects. In principle, the developed generic benchmarks can be applied globally for any food and beverage product. Product category-specific benchmarks were developed when it was not feasible to meet generic benchmarks because of technological and/or taste factors. The whole Unilever global foods and beverages portfolio has been evaluated and actions have been taken to improve the nutritional quality. The advantages of this method over other initiatives to assess the nutritional quality of foods are that it is based on the latest nutritional scientific insights and its global applicability. The Nutrition Score is the first simple, transparent and straightforward method that can be applied globally and across all food and beverage categories to evaluate the nutritional composition. It can help food manufacturers to improve the nutritional value of their products. In addition, the Nutrition Score can be a starting point for a powerful health indicator front-of-pack. This can have a significant positive impact on public health, especially when implemented by all food manufacturers.

Comparing policies to enhance prescribing efficiency in Europe through increasing generic utilization: changes seen and global implications.

PubMed

Godman, Brian; Shrank, William; Andersen, Morten; Berg, Christian; Bishop, Iain; Burkhardt, Thomas; Garuoliene, Kristina; Herholz, Harald; Joppi, Roberta; Kalaba, Marija; Laius, Ott; McGinn, Diane; Samaluk, Vita; Sermet, Catherine; Schwabe, Ulrich; Teixeira, Inês; Tilson, Lesley; Tulunay, F Cankat; Vlahović-Palčevski, Vera; Wendykowska, Kamila; Wettermark, Björn; Zara, Corinne; Gustafsson, Lars L

2010-12-01

The aim of this article was to evaluate the influence of different demand-side measures to enhance the prescribing of generics in ambulatory care based on cross-national comparisons. An observational retrospective study was conducted using administrative databases from across Europe, documenting changes in reimbursed utilization and expenditure of different proton pump inhibitors (PPIs) and statins between 2001 and 2007, alongside different reforms to enhance prescribing efficiency. Utilization was converted to defined daily doses (DDDs) and expenditures were converted to euros. Demand-side measures were collated under the '4 Es'--education, engineering, economics and enforcement--to enable comparisons on the nature and intensity of reforms between countries. There were considerable differences in the utilization of generics and patent-protected PPIs and statins among Western European countries. Decreased utilization of omeprazole and simvastatin, alongside increased utilization of esomeprazole, atorvastatin and rosuvastatin, was seen in countries with limited demand-side measures to counteract commercial pressures. Prescribing restrictions, or a combination of education, prescribing targets and financial incentives, had the greatest influence on enhancing the utilization of omeprazole and simvastatin. For example, there was a threefold reduction in the utilization of atorvastatin in Austria following prescribing restrictions. Multiple demand-side interventions generally had a greater influence than single interventions, with the impact appearing additive. Multiple interventions coupled with initiatives to lower prices of generics considerably enhanced prescribing efficiency. This cross-national study has demonstrated considerable variation in the utilization and expenditure of PPIs and statins across Europe, providing opportunities to further improve prescribing efficiency. The '4 Es' do provide an understandable methodology to document and compare the influence of different demand-side measures, with the influence varying by their extent and intensity. Further reforms are essential given current financial pressures. Consequently, further research will concentrate on the potential to develop a scoring system to help predict the possible impact of different demand-side measures on future utilization patterns.

Assessment of Health-Related Quality of Life after TBI: Comparison of a Disease-Specific (QOLIBRI) with a Generic (SF-36) Instrument

PubMed Central

von Steinbuechel, Nicole; Covic, Amra; Polinder, Suzanne; Kohlmann, Thomas; Cepulyte, Ugne; Poinstingl, Herbert; Backhaus, Joy; Bakx, Wilbert; Bullinger, Monika; Christensen, Anne-Lise; Formisano, Rita; Gibbons, Henning; Höfer, Stefan; Koskinen, Sanna; Maas, Andrew; Neugebauer, Edmund; Powell, Jane; Sarajuuri, Jaana; Sasse, Nadine; Schmidt, Silke; Mühlan, Holger; von Wild, Klaus; Zitnay, George; Truelle, Jean-Luc

2016-01-01

Psychosocial, emotional, and physical problems can emerge after traumatic brain injury (TBI), potentially impacting health-related quality of life (HRQoL). Until now, however, neither the discriminatory power of disease-specific (QOLIBRI) and generic (SF-36) HRQoL nor their correlates have been compared in detail. These aspects as well as some psychometric item characteristics were studied in a sample of 795 TBI survivors. The Shannon H ' index absolute informativity, as an indicator of an instrument's power to differentiate between individuals within a specific group or health state, was investigated. Psychometric performance of the two instruments was predominantly good, generally higher, and more homogenous for the QOLIBRI than for the SF-36 subscales. Notably, the SF-36 “Role Physical,” “Role Emotional,” and “Social Functioning” subscales showed less satisfactory discriminatory power than all other dimensions or the sum scores of both instruments. The absolute informativity of disease-specific as well as generic HRQoL instruments concerning the different groups defined by different correlates differed significantly. When the focus is on how a certain subscale or sum score differentiates between individuals in one specific dimension/health state, the QOLIBRI can be recommended as the preferable instrument. PMID:27022207

Model-Based Fault Diagnosis: Performing Root Cause and Impact Analyses in Real Time

NASA Technical Reports Server (NTRS)

Figueroa, Jorge F.; Walker, Mark G.; Kapadia, Ravi; Morris, Jonathan

2012-01-01

Generic, object-oriented fault models, built according to causal-directed graph theory, have been integrated into an overall software architecture dedicated to monitoring and predicting the health of mission- critical systems. Processing over the generic fault models is triggered by event detection logic that is defined according to the specific functional requirements of the system and its components. Once triggered, the fault models provide an automated way for performing both upstream root cause analysis (RCA), and for predicting downstream effects or impact analysis. The methodology has been applied to integrated system health management (ISHM) implementations at NASA SSC's Rocket Engine Test Stands (RETS).

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.

Health-Related Quality of Life of Nepalese Children With Leukemia Using Pediatric Quality of Life Inventory 4.0 Generic Core Scale.

PubMed

V K, Anu; Onta, Mandira; Joshi, Sarala

Health-related quality of life (HRQOL) is an essential measure to consider when evaluating the full impact of illness in children diagnosed with leukemia. The purpose of the current study was to assess the overall HRQOL and specific functioning subscales of Nepalese children with leukemia using Pediatric Quality of Life Inventory 4.0 Generic Core Scale (PedsQL 4.0), compare self-report with parent proxy report of HRQOL and to identify the determinants affecting HRQOL. After cultural linguistic validation of PedsQL, a descriptive cross-sectional study was conducted on 43 children with leukemia and their parents in B. P. Koirala Memorial Cancer Hospital, Bharatpur via interview schedule. Among the subscales of HRQOL both the child's self-report and parent proxy report scores were highest in social functioning and lowest in emotional functioning subscale. Intraclass correlation coefficient between proxy reports and self-reports were highest (0.828) in physical functioning and lowest (0.493) in social functioning subscales. Age group was significantly associated with the total score, physical functioning subscale, and emotional functioning subscale of only proxy scores. Leukemic children's age-specific needs should be addressed properly to improve their overall HRQOL.

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.

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

Evaluation of generic types of drilling fluid using a risk-based analytic hierarchy process.

PubMed

Sadiq, Rehan; Husain, Tahir; Veitch, Brian; Bose, Neil

2003-12-01

The composition of drilling muds is based on a mixture of clays and additives in a base fluid. There are three generic categories of base fluid--water, oil, and synthetic. Water-based fluids (WBFs) are relatively environmentally benign, but drilling performance is better with oil-based fluids (OBFs). The oil and gas industry developed synthetic-based fluids (SBFs), such as vegetable esters, olefins, ethers, and others, which provide drilling performance comparable to OBFs, but with lower environmental and occupational health effects. The primary objective of this paper is to present a methodology to guide decision-making in the selection and evaluation of three generic types of drilling fluids using a risk-based analytic hierarchy process (AHP). In this paper a comparison of drilling fluids is made considering various activities involved in the life cycle of drilling fluids. This paper evaluates OBFs, WBFs, and SBFs based on four major impacts--operations, resources, economics, and liabilities. Four major activities--drilling, discharging offshore, loading and transporting, and disposing onshore--cause the operational impacts. Each activity involves risks related to occupational injuries (safety), general public health, environmental impact, and energy use. A multicriteria analysis strategy was used for the selection and evaluation of drilling fluids using a risk-based AHP. A four-level hierarchical structure is developed to determine the final relative scores, and the SBFs are found to be the best option.

Impact of cough across different chronic respiratory diseases: comparison of two cough-specific health-related quality of life questionnaires.

PubMed

Polley, Liam; Yaman, Nurman; Heaney, Liam; Cardwell, Chris; Murtagh, Eimear; Ramsey, John; MacMahon, Joseph; Costello, Richard W; McGarvey, Lorcan

2008-08-01

Cough is a prominent symptom across a range of common chronic respiratory diseases and impacts considerably on patient health status. We undertook a cross-sectional comparison of scores from two cough-specific health-related quality of life (HRQoL) questionnaires, the Leicester Cough Questionnaire (LCQ), and the Cough Quality of Life Questionnaire (CQLQ), together with a generic HRQoL measure, the EuroQol. Questionnaires were administered to and spirometry performed on 147 outpatients with chronic cough (n = 83), COPD (n = 18), asthma (n = 20), and bronchiectasis (n = 26). There was no significant difference in the LCQ and CQLQ total scores between groups (p = 0.24 and p = 0.26, respectively). Exploratory analyses of questionnaire subdomains revealed differences in psychosocial issues and functional impairment between the four groups (p = 0.01 and p = 0.05, respectively). CQLQ scores indicated that chronic coughers have more psychosocial issues than patients with bronchiectasis (p = 0.03) but less functional impairment than COPD patients (p = 0.04). There was a significant difference in generic health status across the four disease groups (p = 0.04), with poorest health status in COPD patients. A significant inverse correlation was observed between CQLQ and LCQ in each disease group (chronic cough r = - 0.56, p < 0.001; COPD r = - 0.49, p = 0.04; asthma r = - 0.94, p < 0.001; and bronchiectasis r = - 0.88, p < 0.001). There was no correlation between cough questionnaire scores and FEV(1) in any group, although a significant correlation between EuroQol visual analog scale component and FEV(1) (r = 0.639, p = 0.004) was observed in COPD patients. Cough adversely affects health status across a range of common respiratory diseases. The LCQ and CQLQ can each provide important additional information concerning the impact of cough.

State Curriculum Mandates and Student Knowledge of Personal Finance.

ERIC Educational Resources Information Center

Tennyson, Sharon; Nguyen, Chau

2001-01-01

A financial literacy test was administered to 1,643 high school students in 31 states. State mandates for generic consumer education were not associated with higher scores. Students in states requiring specific personal finance coursework scored significantly higher than those in generic-mandate or no-mandate states. (Contains 23 references.) (SK)

A Generic Approach for Pen-Based User Interface Development

NASA Astrophysics Data System (ADS)

Macé, Sébastien; Anquetil, Éric

Pen-based interaction is an intuitive way to realize hand drawn structured documents, but few applications take advantage of it. Indeed, the interpretation of the user hand drawn strokes in the context of document is a complex problem. In this paper, we propose a new generic approach to develop such systems based on three independent components. The first one is a set of graphical and editing functions adapted to pen interaction. The second one is a rule-based formalism that models structured document composition and the corresponding interpretation process. The last one is a hand drawn stroke analyzer that is able to interpret strokes progressively, directly while the user is drawing. We highlight in particular the human-computer interaction induced from this progressive interpretation process. Thanks to this generic approach, three pen-based system prototypes have already been developed, for musical score editing, for graph editing, and for UML class diagram editing

Quality of life in children with non-cystic-fibrosis bronchiectasis.

PubMed

Gokdemir, Yasemin; Hamzah, Ameer; Erdem, Ela; Cimsit, Cagatay; Ersu, Refika; Karakoc, Fazilet; Karadag, Bulent

2014-01-01

Non-cystic-fibrosis bronchiectasis (non-CF BE) continues to be a problem in developing countries and it is therefore important to examine and assess this disease. The aims of this prospective study were to evaluate the health-related quality of life (HRQOL) in non-CF BE children and also to assess the risk factors associated with HRQOL. Forty-two non-CF BE patients between the ages of 9 and 18 years were enrolled in the study. All recruited patients completed the generic Short-Form-36 (SF-36), the St. George's Respiratory Questionnaire (SGRQ) for disease-specific QOL scale and forms on socioeconomic status (SES). The extent and severity of CT abnormalities were evaluated by using the modified Bhalla scoring system. Association between HRQOL questionnaires and demographic variables, pulmonary function test, high-resolution CT scores and SES were evaluated. SF-36 and SGRQ subscales all correlated inversely with each other (SF-36 physical component summary with SGRQ symptoms score: r = -0.466, p = 0.001, activity score: r = -0.666, p = 0.000 and impact score: r = -0.667, p = 0.000. SF-36 mental component summary with SGRQ symptoms score: r = -0.396, p = 0.005, activity score: r = -0.533, p = 0.000 and impact score: r = -0.512, p = 0.000). There was an inverse correlation between SGRQ symptoms scores and the duration of regular follow-up (r = -0.3, p = 0.04). The symptoms subscale of SGRQ correlated positively with low values for pulmonary function testing (r = -0.417, p = 0.003) and frequent antibiotic requirements (r = 0.303, p = 0.035). Early diagnosis and regular follow-up of children with non-CF BE is important for improving their QOL. As expected, the severity and frequency of symptoms are inversely related to the pulmonary function and the QOL scores. A disease-specific questionnaire should be developed to monitor QOL in children with non-CF BE. © 2014 S. Karger AG, Basel

Assessment of knowledge and perceptions toward generic medicines among basic science undergraduate medical students at Aruba.

PubMed

Shankar, P Ravi; Herz, Burton L; Dubey, Arun K; Hassali, Mohamed A

2016-10-01

Use of generic medicines is important to reduce rising health-care costs. Proper knowledge and perception of medical students and doctors toward generic medicines are important. Xavier University School of Medicine in Aruba admits students from the United States, Canada, and other countries to the undergraduate medical (MD) program. The present study was conducted to study the knowledge and perception about generic medicines among basic science MD students. The cross-sectional study was conducted among first to fifth semester students during February 2015. A previously developed instrument was used. Basic demographic information was collected. Respondent's agreement with a set of statements was noted using a Likert-type scale. The calculated total score was compared among subgroups of respondents. One sample Kolmogorov-Smirnov test was used to study the normality of distribution, Independent samples t -test to compare the total score for dichotomous variables, and analysis of variance for others were used for statistical analysis. Fifty-six of the 85 students (65.8%) participated. Around 55% of respondents were between 20 and 25 years of age and of American nationality. Only three respondents (5.3%) provided the correct value of the regulatory bioequivalence limits. The mean total score was 43.41 (maximum 60). There was no significant difference in scores among subgroups. There was a significant knowledge gap with regard to the regulatory bioequivalence limits for generic medicines. Respondents' level of knowledge about other aspects of generic medicines was good but could be improved. Studies among clinical students in the institution and in other Caribbean medical schools are required. Deficiencies were noted and we have strengthened learning about generic medicines during the basic science years.

School system evaluation by value added analysis under endogeneity.

PubMed

Manzi, Jorge; San Martín, Ernesto; Van Bellegem, Sébastien

2014-01-01

Value added is a common tool in educational research on effectiveness. It is often modeled as a (prediction of a) random effect in a specific hierarchical linear model. This paper shows that this modeling strategy is not valid when endogeneity is present. Endogeneity stems, for instance, from a correlation between the random effect in the hierarchical model and some of its covariates. This paper shows that this phenomenon is far from exceptional and can even be a generic problem when the covariates contain the prior score attainments, a typical situation in value added modeling. Starting from a general, model-free definition of value added, the paper derives an explicit expression of the value added in an endogeneous hierarchical linear Gaussian model. Inference on value added is proposed using an instrumental variable approach. The impact of endogeneity on the value added and the estimated value added is calculated accurately. This is also illustrated on a large data set of individual scores of about 200,000 students in Chile.

Quality-of-Life Impairments Persist Six Months After Treatment of Graves' Hyperthyroidism and Toxic Nodular Goiter: A Prospective Cohort Study.

PubMed

Cramon, Per; Winther, Kristian Hillert; Watt, Torquil; Bonnema, Steen Joop; Bjorner, Jakob Bue; Ekholm, Ola; Groenvold, Mogens; Hegedüs, Laszlo; Feldt-Rasmussen, Ulla; Rasmussen, Åse Krogh

2016-08-01

The treatment of hyperthyroidism is aimed at improving health-related quality of life (HRQoL) and reducing morbidity and mortality. However, few studies have used validated questionnaires to assess HRQoL prospectively in such patients. The purpose of this study was to assess the impact of hyperthyroidism and its treatment on HRQoL using validated disease-specific and generic questionnaires. This prospective cohort study enrolled 88 patients with Graves' hyperthyroidism and 68 with toxic nodular goiter from endocrine outpatient clinics at two Danish university hospitals. The patients were treated with antithyroid drugs, radioactive iodine, or surgery. Disease-specific and generic HRQoL were assessed using the thyroid-related patient-reported outcome (ThyPRO) and the Medical Outcomes Study 36-item Short Form (SF-36), respectively, evaluated at baseline and six-month follow-up. The scores were compared with those from two general population samples who completed ThyPRO (n = 739) and SF-36 (n = 6638). Baseline scores for patients with Graves' hyperthyroidism and toxic nodular goiter were significantly worse than those for the general population scores on all comparable ThyPRO scales and all SF-36 scales and component summaries. ThyPRO scores improved significantly with treatment on all scales in Graves' hyperthyroidism and four scales in toxic nodular goiter, while SF-36 scores improved on five scales and both component summaries in Graves' hyperthyroidism and only one scale in toxic nodular goiter. In Graves' hyperthyroidism, large treatment effects were observed on three ThyPRO scales (Hyperthyroid Symptoms, Tiredness, Overall HRQoL) and moderate effects on three scales (Anxiety, Emotional Susceptibility, Impaired Daily Life), while moderate effects were seen in two ThyPRO scales in toxic nodular goiter (Anxiety, Overall HRQoL). However, significant disease-specific and generic HRQoL deficits persisted on multiple domains across both patient groups. Graves' hyperthyroidism and toxic nodular goiter cause severe disease-specific and generic HRQoL impairments, and HRQoL deficits persist in both patient groups six months after treatment. These data have the potential to improve communication between physicians and patients by offering realistic estimates of expected HRQoL impairments and treatment effects. Future studies should identify risk factors for persistent HRQoL deficits, compare HRQoL effects of the various therapies, and thereby aid in determining the optimal treatment strategies.

Societal value of generic medicines beyond cost-saving through reduced prices.

PubMed

Dylst, Pieter; Vulto, Arnold; Simoens, Steven

2015-01-01

This paper aims to provide an overview of the added societal value of generic medicines beyond their cost-saving potential through reduced prices. In addition, an observational case study will document the impact of generic entry on access to pharmacotherapy in The Netherlands and an illustrative exercise was carried out to highlight the budget impact of generic entry. A narrative literature review was carried out to explore the impact of generic medicines on access to pharmacotherapy, innovation and medication adherence. Data from the Medicines and Medical Devices Information Project database in The Netherlands were used for the case study in which the impact of generic medicine entrance on the budget and the number of users was calculated as an illustrative exercise. Generic medicines have an additional societal value beyond their cost-saving potential through reduced prices. Generic medicines increase access to pharmacotherapy, provide a stimulus for innovation by both originator companies and generic companies and, under the right circumstances, have a positive impact on medication adherence. Generic medicines offer more to society than just their cost-saving potential through reduced prices. As such, governments must not focus only on the prices of generic medicines as this will threaten their long-term sustainability. Governments must therefore act appropriately and implement a coherent set of policies to increase the use of generic medicines.

Validity and Diagnostic Accuracy of Scores from the Autism Diagnostic Observation Schedule-Generic

ERIC Educational Resources Information Center

Reid, Melissa A.

2012-01-01

The purpose of this study was to examine the internal structure, relationships with other variables, and diagnostic accuracy of scores on the Autism Diagnostic Observation Schedule-Generic (ADOS-G; Lord et al., 1999) for the purpose of diagnostic decision-making. Participants were 462 children enrolled in a public school district in the southern…

Impact of genital warts on emotional and sexual well-being differs by gender.

PubMed

Vriend, Henrike J; Nieuwkerk, Pythia T; van der Sande, Marianne A B

2014-11-01

To assess gender-specific impact of genital warts on health-related quality of life (HRQoL), and to explore to what extent sexual characteristics and clinical symptoms influenced the impact on emotional and sexual well-being of both sexes. We conducted a survey of sexual and clinical characteristics from persons diagnosed with genital warts at STI clinics. HRQoL was measured using two measurement tools: 1) the generic EQ-5D; and 2) the genital warts-specific CECA-10 including an emotional well-being and a sexual activity dimension. The EQ-5D scores were compared with scores of the general population. Descriptive analyses were used to explore characteristics associated with HRQoL scores stratified for gender. The HRQoL-measurement tools showed that genital warts have especially an emotional impact. The impact of genital warts on HRQoL was greater for women than for men. In addition, the CECA-10 showed that in women the impact of genital warts on sexual activity was influenced by age, relationship status and number of warts. No related factors were seen in men. Genital warts have a greater impact on women than on men. In women, sexual and clinical factors influenced the impact of genital warts on well-being, whereas in men no such factors were found. © The Author(s) 2014 Reprints and permissions: sagepub.co.uk/journalsPermissions.nav.

Quality of life in children and adolescents with allergic rhinitis.

PubMed

Silva, Carlos Henrique Martins da; Silva, Taís Estevão da; Morales, Nívea Macedo O; Fernandes, Karla P; Pinto, Rogério M C

2009-01-01

Allergic rhinitis (AR) remains a significant pediatric health problem because of the burden of uncontrolled symptoms on daily activities and on general well being. to assess the impact of AR on health-related quality of life (HRQL) of children and adolescents using a generic instrument, the Child Health Questionnaire (CHQ - PF50). Between January and November 2004, parents or caregivers of 23 children and adolescents with AR without comorbidities and with positive prick tests for at least one air allergen were invited to participate of a cross-sectional study and asked to answer the self-administered CHQ-PF50. The scores were compared to those of healthy children and adolescents. Patient scores were lower (p<0.05) than healthy subsets in both the physical and psychosocial summaries and in most of the CHQ-PF50 scales (p<0,05), except for the 'change in health' scale. The size effect was higher in the physical score compared to the psychosocial summary score. allergic rhinitis has a global negative impact on the HRQL of children and adolescents, with major repercussions in physical function; AR also negatively affects family relations.

Different initiatives across Europe to enhance losartan utilization post generics: impact and implications.

PubMed

Moon, James C; Godman, Brian; Petzold, Max; Alvarez-Madrazo, Samantha; Bennett, Kathleen; Bishop, Iain; Bucsics, Anna; Hesse, Ulrik; Martin, Andrew; Simoens, Steven; Zara, Corinne; Malmström, Rickard E

2014-01-01

There is an urgent need for health authorities across Europe to fully realize potential savings from increased use of generics to sustain their healthcare systems. A variety of strategies were used across Europe following the availability of generic losartan, the first angiotensin receptor blocker (ARB) to be approved and marketed, to enhance its prescribing vs. single-sourced drugs in the class. Demand-side strategies ranged from 100% co-payment for single-sourced ARBs in Denmark to no specific measures. We hypothesized this heterogeneity of approaches would provide opportunities to explore prescribing in a class following patent expiry. Contrast the impact of the different approaches among European countries and regions to the availability of generic losartan to provide future guidance. Retrospective segmented regression analyses applying linear random coefficient models with country specific intercepts and slopes were used to assess the impact of the various initiatives across Europe following the availability of generic losartan. Utilization measured in defined daily doses (DDDs). Price reductions for generic losartan were also measured. Utilization of losartan was over 90% of all ARBs in Denmark by the study end. Multiple measures in Sweden and one English primary care group also appreciably enhanced losartan utilization. Losartan utilization actually fell in some countries with no specific demand-side measures. Considerable differences were seen in the prices of generic losartan. Delisting single-sourced ARBs produced the greatest increase in losartan utilization. Overall, multiple demand-side measures are needed to change physician prescribing habits to fully realize savings from generics. There is no apparent "spill over" effect from one class to another to influence future prescribing patterns even if these are closely related.

Different initiatives across Europe to enhance losartan utilization post generics: impact and implications

PubMed Central

Moon, James C.; Godman, Brian; Petzold, Max; Alvarez-Madrazo, Samantha; Bennett, Kathleen; Bishop, Iain; Bucsics, Anna; Hesse, Ulrik; Martin, Andrew; Simoens, Steven; Zara, Corinne; Malmström, Rickard E.

2014-01-01

Introduction: There is an urgent need for health authorities across Europe to fully realize potential savings from increased use of generics to sustain their healthcare systems. A variety of strategies were used across Europe following the availability of generic losartan, the first angiotensin receptor blocker (ARB) to be approved and marketed, to enhance its prescribing vs. single-sourced drugs in the class. Demand-side strategies ranged from 100% co-payment for single-sourced ARBs in Denmark to no specific measures. We hypothesized this heterogeneity of approaches would provide opportunities to explore prescribing in a class following patent expiry. Objective: Contrast the impact of the different approaches among European countries and regions to the availability of generic losartan to provide future guidance. Methodology: Retrospective segmented regression analyses applying linear random coefficient models with country specific intercepts and slopes were used to assess the impact of the various initiatives across Europe following the availability of generic losartan. Utilization measured in defined daily doses (DDDs). Price reductions for generic losartan were also measured. Results: Utilization of losartan was over 90% of all ARBs in Denmark by the study end. Multiple measures in Sweden and one English primary care group also appreciably enhanced losartan utilization. Losartan utilization actually fell in some countries with no specific demand-side measures. Considerable differences were seen in the prices of generic losartan. Conclusion: Delisting single-sourced ARBs produced the greatest increase in losartan utilization. Overall, multiple demand-side measures are needed to change physician prescribing habits to fully realize savings from generics. There is no apparent “spill over” effect from one class to another to influence future prescribing patterns even if these are closely related. PMID:25339902

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.

Do generic firms and the Spanish public purchaser respond to consumer price differences of generics under reference pricing?

PubMed

Puig-Junoy, Jaume; Moreno-Torres, Iván

2010-12-01

To assess the impact of competition on the consumer price and the average price paid by the National Health System (NHS) under reference pricing in the Spanish generic market. Descriptive analysis of the time trend in consumer prices before and after the application of reference pricing for the eight most sold active ingredients from 1997 to 2009. The entry of a generic at a lower consumer price than that of the brand-name pharmaceutical or the first generic does not cause a voluntary reduction in the consumer price of either the brand drug or the first generic, either before or after the application of RP. Generic entry at a lower consumer price than previously existing pharmaceuticals always causes a slight reduction in the average price paid by the NHS; however, the average price paid by the NHS is always notably higher than the lowest, the difference being greater in relative terms under reference pricing. The Spanish RP system results in very little consumer price competition between generic firms, price reduction thus being limited to regulatory measures. NHS purchases show little sensitivity to price differences between equivalent drugs priced at or below the reference price. Copyright © 2010 Elsevier Ireland Ltd. All rights reserved.

Patient socioeconomic determinants of the choice of generic versus brand name drugs in the context of a reference price system: evidence from Belgian prescription data.

PubMed

Farfan-Portet, Maria-Isabel; Van de Voorde, Carine; Vrijens, France; Vander Stichele, Robert

2012-06-01

The generic reference price system (RPS) can impose a financial penalty for patients using a brand name drug instead of its generic alternative. Previous studies on the impact of the RPS have not considered the potentially differential effect of using generic alternatives for individuals with a different socioeconomic background. However, patients' characteristics might determine their overall knowledge of the existence of the system and thus of the financial burden to which they may be confronted. The association between patients' characteristics and the use of generic drugs versus brand name drugs was analyzed for ten highly prescribed pharmaceutical molecules included in the Belgian generic reference price system. Prescriptions were obtained from a 10% sample of all general practitioners in 2008 (corresponding to 120,670 adult patients and 368,101 prescriptions). For each pharmaceutical molecule, logistic regression models were performed, with independent variables for patient socioeconomic background at the individual level (work status, having a guaranteed income and being entitled to increased reimbursement of co-payments) and at the level of the neighborhood (education). The percentage of generic prescriptions ranged from 24.7 to 76.4%, and the mean reference supplement in 2008 ranged from €4.3 to €37.8. For seven molecules, higher use of a generic alternative was associated with either having a guaranteed income, with receiving increased reimbursement of co-payments or with living in areas with the lowest levels of education. Globally, results provided evidence that the generic RPS in Belgium does not lead to a higher financial burden on individuals from a low socioeconomic background.

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.

Projected economic impact of clinical findings of generic entry of topiramate on G4 European countries.

PubMed

Paradis, Pierre Emmanuel; Latrémouille-Viau, Dominick; Moore, Yuliya; Mishagina, Natalia; Lafeuille, Marie-Hélène; Lefebvre, Patrick; Gaudig, Maren; Duh, Mei Sheng

2009-07-01

To explore the effects of generic substitution of the antiepileptic drug (AED) topiramate (Topamax) in Canada; to convert observed Canadian costs into the settings of France, Germany, Italy, and the United Kingdom (UK); and to forecast the economic impact of generic topiramate entry in these four European countries. Health claims from Régie de l'assurance maladie du Québec (RAMQ) plan (1/2006-9/2008) and IMS Health data (1998-2008) were used. Patients with epilepsy and > or = 2 topiramate dispensings were selected. An open-cohort design was used to classify observation into mutually-exclusive periods of branded versus generic use of topiramate. Canadian healthcare utilization and costs (2007 CAN$/person-year) were compared between periods using multivariate models. Annualized per-patient costs (2007 euro or 2007 pound sterling/person-year) were converted using Canadian utilization rates, European prices and service-use ratios. Non-parametric bootstrap served to assess statistical significance of cost differences. Topiramate market was forecasted following generic entry (09/2009-09/2010) using autoregressive models based on the European experience. The economic impact of generic topiramate entry was estimated for each country. A total of 1164 patients (mean age: 39.8 years, 61.7% female) were observed for 2.6 years on average. After covariates adjustment, generic-use periods were associated with increased pharmacy dispensings (other AEDs: +0.95/person-year, non-AEDs: +12.28/person-year, p < 0.001), hospitalizations ( + 0.08/person-year, p = 0.015), and lengths of hospital stays (+0.51 days/person-year, p < 0.001). Adjusted costs, excluding topiramate, were CAN$1060/person-year higher during generic use (p = 0.005). Converted per-patient costs excluding topiramate were significantly higher for generic relative to brand periods in all European countries (adjusted cost differences per person-year: 706-815 euro, p < 0.001 for all comparisons). System-wide costs would increase from 3.5 to 24.4% one year after generic entry. Study limitations include the absence of indirect costs, possible claim inaccuracies, and IMS data limitations. Higher health costs were projected for G4 European countries from the Canadian experience following the generic entry of topiramate.

Key Technical Aspects Influencing the Accuracy of Tablet Subdivision.

PubMed

Teixeira, Maíra T; Sá-Barreto, Lívia C L; Gratieri, Taís; Gelfuso, Guilherme M; Silva, Izabel C R; Cunha-Filho, Marcílio S S

2017-05-01

Tablet subdivision is a common practice used mainly for dose adjustment. The aim of this study was to investigate how the technical aspects of production as well as the method of tablets subdivision (employing a tablet splitter or a kitchen knife) influence the accuracy of this practice. Five drugs commonly used as subdivided tablets were selected. For each drug, the innovator drug product, a scored-generic and a non-scored generic were investigated totalizing fifteen drug products. Mechanical and physical tests, including image analysis, were performed. Additionally, comparisons were made between tablet subdivision method, score, shape, diluent composition and coating. Image analysis based on surface area was a useful tool as an alternative assay to evaluate the accuracy of tablet subdivision. The tablet splitter demonstrates an advantage relative to a knife as it showed better results in weight loss and friability tests. Oblong, coated and scored tablets had better results after subdivision than round, uncoated and non-scored tablets. The presence of elastic diluents such as starch and dibasic phosphate dehydrate conferred a more appropriate behaviour for the subdivision process than plastic materials such as microcrystalline cellulose and lactose. Finally, differences were observed between generics and their innovator products in all selected drugs with regard the quality control assays in divided tablet, which highlights the necessity of health regulations to consider subdivision performance at least in marketing authorization of generic products.

Estimating structural collapse fragility of generic building typologies using expert judgment

USGS Publications Warehouse

Jaiswal, Kishor; Wald, David J.; Perkins, David M.; Aspinall, Willy P.; Kiremidjian, Anne S.

2014-01-01

The structured expert elicitation process proposed by Cooke (1991), hereafter referred to as Cooke's approach, is applied for the first time in the realm of structural collapse-fragility assessment for selected generic construction types. Cooke's approach works on the principle of objective calibration scoring of judgments couple with hypothesis testing used in classical statistics. The performance-based scoring system reflects the combined measure of an expert's informativeness about variables in the problem are under consideration, and their ability to enumerate, in a statistically accurate way through expressing their true beliefs, the quantitative uncertainties associated with their assessments. We summarize the findings of an expert elicitation workshop in which a dozen earthquake-engineering professionals from around the world were engaged to estimate seismic collapse fragility for generic construction types. Development of seismic collapse fragility-functions was accomplished by combining their judgments using weights derived from Cooke's method. Although substantial effort was needed to elicit the inputs of these experts successfully, we anticipate that the elicitation strategy described here will gain momentum in a wide variety of earthquake seismology and engineering hazard and risk analyses where physical model and data limitations are inherent and objective professional judgment can fill gaps.

Estimating structural collapse fragility of generic building typologies using expert judgment

USGS Publications Warehouse

Jaiswal, Kishor S.; Wald, D.J.; Perkins, D.; Aspinall, W.P.; Kiremidjian, Anne S.; Deodatis, George; Ellingwood, Bruce R.; Frangopol, Dan M.

2014-01-01

The structured expert elicitation process proposed by Cooke (1991), hereafter referred to as Cooke’s approach, is applied for the first time in the realm of structural collapse-fragility assessment for selected generic construction types. Cooke’s approach works on the principle of objective calibration scoring of judgments coupled with hypothesis testing used in classical statistics. The performance-based scoring system reflects the combined measure of an expert’s informativeness about variables in the problem area under consideration, and their ability to enumerate, in a statistically accurate way through expressing their true beliefs, the quantitative uncertainties associated with their assessments. We summarize the findings of an expert elicitation workshop in which a dozen earthquake-engineering professionals from around the world were engaged to estimate seismic collapse fragility for generic construction types. Development of seismic collapse fragility functions was accomplished by combining their judgments using weights derived from Cooke’s method. Although substantial effort was needed to elicit the inputs of these experts successfully, we anticipate that the elicitation strategy described here will gain momentum in a wide variety of earthquake seismology and engineering hazard and risk analyses where physical model and data limitations are inherent and objective professional judgment can fill gaps.

Impact of price deregulation policy on the affordability of essential medicines for women's health: a panel data analysis.

PubMed

Liu, Junjie; Wang, Liming; Liu, Chenxi; Zhang, Xinping

2017-12-01

A new policy which required deregulation on prices of off-patent medicines for women's health during procurement was introduced in China in September 2015. The current study examines this policy's impact on the affordability of essential medicines for women's health. Based on product-level panel data, a fixed effect regression model is employed by using procurement records from Hubei Centralist Tender for Drug Purchase platform. In the model, Affordability was measured with prices. The Competition consists of two parts: generic competition and therapeutic class competition which are measured with generic competitors and therapeutic substitutes. Instrument variable is used to deal with endogeneity. The policy helped control prices of essential medicines for women's health. Generic competition helped control prices, however, therapeutic class competition caused higher prices. The new policy helped enhance the affordability of essential medicines for women's health as expected, which provides empirical evidence on price deregulation. Besides, generic competition is important in price control despite strict regulatory system in China.

Comparison of Generic-to-Brand Switchback Rates Between Generic and Authorized Generic Drugs.

PubMed

Hansen, Richard A; Qian, Jingjing; Berg, Richard; Linneman, James; Seoane-Vazquez, Enrique; Dutcher, Sarah K; Raofi, Saeid; Page, C David; Peissig, Peggy

2017-04-01

Generic drugs contain identical active ingredients as their corresponding brand drugs and are pharmaceutically equivalent and bioequivalent, whereas authorized generic drugs (AGs) contain both identical active and inactive ingredients as their corresponding brand drugs but are marketed as generics. This study compares generic-to-brand switchback rates between generic and AGs. Retrospective cohort study. Claims and electronic health record data from a regional U.S. health care system. The full cohort consisted of 5542 unique patients who received select branded drugs during the 6 months prior to their generic drug market availability (between 1999 and 2014) and then were switched to an AG or generic drug within 30 months of generic drug entry. For these patients, 5929 unique patient-drug combinations (867 with AGs and 5062 with generic drugs) were evaluated. Ten drugs with AGs and generics marketed between 1999 and 2014 were evaluated. The date of the first generic prescription was considered the index date for each drug, and it marked the beginning of follow-up to evaluate the occurrence of generic-to-brand switchback patterns over the subsequent 30 months. Switchback rates were compared between patients receiving AGs versus those receiving generics using multivariable Cox proportional hazards models, controlling for individual drug effects, age, sex, Charlson Comorbidity Score, pre-index drug use characteristics, and pre-index health care utilization. Among the 5542 unique patients who switched from brand to generic or brand to AG, 264 (4.8%) switched back to the brand drug. Overall switchback rates were similar for AGs compared with generics (hazard ratio [HR] 0.86, 95% confidence interval [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 the other drugs evaluated. Overall switchback rates were similar between AG 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 explored further. © 2017 Pharmacotherapy Publications, Inc.

Impact of pharmaceutical policy interventions on utilization of antipsychotic medicines in Finland and Portugal in times of economic recession: interrupted time series analyses

PubMed Central

2014-01-01

Objectives To analyze the impacts of pharmaceutical sector policies implemented to contain country spending during the economic recession – a reference price system in Finland and a mix of policies including changes in reimbursement rates, a generic promotion campaign and discounts granted to the public payer in Portugal – on utilization of, as a proxy for access to, antipsychotic medicines. Methodology We obtained monthly IMS Health sales data in standard units of antipsychotic medicines in Portugal and Finland for the period January 2007 to December 2011. We used an interrupted time series design to estimate changes in overall use and generic market shares by comparing pre-policy and post-policy levels and trends. Results Both countries’ policy approaches were associated with slight, likely unintended, decreases in overall use of antipsychotic medicines and with increases in generic market shares of major antipsychotic products. In Finland, quetiapine and risperidone generic market shares increased substantially (estimates one year post-policy compared to before, quetiapine: 6.80% [3.92%, 9.68%]; risperidone: 11.13% [6.79%, 15.48%]. The policy interventions in Portugal resulted in a substantially increased generic market share for amisulpride (estimate one year post-policy compared to before: 22.95% [21.01%, 24.90%]; generic risperidone already dominated the market prior to the policy interventions. Conclusions Different policy approaches to contain pharmaceutical expenditures in times of the economic recession in Finland and Portugal had intended – increased use of generics – and likely unintended – slightly decreased overall sales, possibly consistent with decreased access to needed medicines – impacts. These findings highlight the importance of monitoring and evaluating the effects of pharmaceutical policy interventions on use of medicines and health outcomes. PMID:25062657

Impact of pharmaceutical policy interventions on utilization of antipsychotic medicines in Finland and Portugal in times of economic recession: interrupted time series analyses.

PubMed

Leopold, Christine; Zhang, Fang; Mantel-Teeuwisse, Aukje K; Vogler, Sabine; Valkova, Silvia; Ross-Degnan, Dennis; Wagner, Anita K

2014-07-25

To analyze the impacts of pharmaceutical sector policies implemented to contain country spending during the economic recession--a reference price system in Finland and a mix of policies including changes in reimbursement rates, a generic promotion campaign and discounts granted to the public payer in Portugal - on utilization of, as a proxy for access to, antipsychotic medicines. We obtained monthly IMS Health sales data in standard units of antipsychotic medicines in Portugal and Finland for the period January 2007 to December 2011. We used an interrupted time series design to estimate changes in overall use and generic market shares by comparing pre-policy and post-policy levels and trends. Both countries' policy approaches were associated with slight, likely unintended, decreases in overall use of antipsychotic medicines and with increases in generic market shares of major antipsychotic products. In Finland, quetiapine and risperidone generic market shares increased substantially (estimates one year post-policy compared to before, quetiapine: 6.80% [3.92%, 9.68%]; risperidone: 11.13% [6.79%, 15.48%]. The policy interventions in Portugal resulted in a substantially increased generic market share for amisulpride (estimate one year post-policy compared to before: 22.95% [21.01%, 24.90%]; generic risperidone already dominated the market prior to the policy interventions. Different policy approaches to contain pharmaceutical expenditures in times of the economic recession in Finland and Portugal had intended--increased use of generics--and likely unintended--slightly decreased overall sales, possibly consistent with decreased access to needed medicines--impacts. These findings highlight the importance of monitoring and evaluating the effects of pharmaceutical policy interventions on use of medicines and health outcomes.

The efficacy and safety of on-demand Elonza; a generic product of sildenafil in Thai men with erectile dysfunction.

PubMed

Wijitsettakul, Udomsak; Pempongkosol, Sompol

2013-06-01

To evaluate the efficacy and safety of Elonza (generic product of sildenafil) 100 mg, a phosphodiesterase type 5 (PDE5) inhibitor, in Thai men with erectile dysfunction (ED). This prospective, Cohort study was conducted for eight weeks. Two hundred ten male patients, older than 20 years of age with ED were enrolled to receive generic product of sildenafil 100 mg taken as needed. Efficacy is evaluated through the International Index of Erectile Function (IIEF) scores for the five separate response domains, erectile function, orgasmic function, sexual desire, intercourse satisfaction, and overall satisfaction domain. After sildenafil administration, erectile function domain scores were significantly increased from baseline, 5.02 (p < 0.001) and 7.19 (p < 0.001) in one month and two months, respectively. Intercourse satisfaction domain scores and overall satisfaction domain scores were significantly increased from baseline, 3.17 (p < 0.001) and 1.74 (p < 0.001) in two months, respectively. Most treatment emergent adverse events were mild or moderate. The most frequent treatment-emergent adverse events were flushing (13.2%), nasal congestion (9.8%), abnormal vision (4.9%), headache (4.4%), dizziness (2.9%), and dyspepsia (0.5%). Elonza, a generic product of sildenafil, was an effective and well-tolerated treatment for ED in Thai men.

C3 generic workstation: Performance metrics and applications

NASA Technical Reports Server (NTRS)

Eddy, Douglas R.

1988-01-01

The large number of integrated dependent measures available on a command, control, and communications (C3) generic workstation under development are described. In this system, embedded communications tasks will manipulate workload to assess the effects of performance-enhancing drugs (sleep aids and decongestants), work/rest cycles, biocybernetics, and decision support systems on performance. Task performance accuracy and latency will be event coded for correlation with other measures of voice stress and physiological functioning. Sessions will be videotaped to score non-verbal communications. Physiological recordings include spectral analysis of EEG, ECG, vagal tone, and EOG. Subjective measurements include SWAT, fatigue, POMS and specialized self-report scales. The system will be used primarily to evaluate the effects on performance of drugs, work/rest cycles, and biocybernetic concepts. Performance assessment algorithms will also be developed, including those used with small teams. This system provides a tool for integrating and synchronizing behavioral and psychophysiological measures in a complex decision-making environment.

Towards generic online multicriteria decision support in patient-centred health care.

PubMed

Dowie, Jack; Kjer Kaltoft, Mette; Salkeld, Glenn; Cunich, Michelle

2015-10-01

To introduce a new online generic decision support system based on multicriteria decision analysis (MCDA), implemented in practical and user-friendly software (Annalisa©). All parties in health care lack a simple and generic way to picture and process the decisions to be made in pursuit of improved decision making and more informed choice within an overall philosophy of person- and patient-centred care. The MCDA-based system generates patient-specific clinical guidance in the form of an opinion as to the merits of the alternative options in a decision, which are all scored and ranked. The scores for each option combine, in a simple expected value calculation, the best estimates available now for the performance of those options on patient-determined criteria, with the individual patient's preferences, expressed as importance weightings for those criteria. The survey software within which the Annalisa file is embedded (Elicia©) customizes and personalizes the presentation and inputs. Principles relevant to the development of such decision-specific MCDA-based aids are noted and comparisons with alternative implementations presented. The necessity to trade-off practicality (including resource constraints) with normative rigour and empirical complexity, in both their development and delivery, is emphasized. The MCDA-/Annalisa-based decision support system represents a prescriptive addition to the portfolio of decision-aiding tools available online to individuals and clinicians interested in pursuing shared decision making and informed choice within a commitment to transparency in relation to both the evidence and preference bases of decisions. Some empirical data establishing its usability are provided. © 2013 The Authors. Health Expectations published by John Wiley & Sons Ltd.

The impact of reference pricing and extension of generic substitution on the daily cost of antipsychotic medication in Finland.

PubMed

Koskinen, Hanna; Ahola, Elina; Saastamoinen, Leena K; Mikkola, Hennamari; Martikainen, Jaana E

2014-12-01

To assess the impact of reference pricing and extension of generic substitution on the daily cost of antipsychotic drugs in Finland during the first year after its launch. Furthermore, the additional impact of reference pricing on prior implemented generic substitution is assessed. A retrospective analysis was performed between 2006 and 2010. A segmented linear regression analysis of interrupted time series was used to estimate changes in the levels and trends in the cost of one day of treatment. Of the study drugs, clozapine belonged to generic substitution already at the start of the study period while olanzapine and quetiapine were included in generic substitution alongside with reference pricing in 2009. Risperidone was included in generic substitution in 2008, before reference pricing. A substantial decrease in the daily cost of all four antipsychotic substances was seen after one year of the implementation of reference pricing and the extension of generic substitution. The impact ranged from -29.9% to -66.3%, and it was most substantial on the daily cost of olanzapine. Also in the daily cost of risperidone a substantial decrease of -43.3% was observed. However, most of these savings, -32.6%, were generated by generic substitution which had been adopted prior. Reference pricing and the extension of generic substitution produced substantial savings on antipsychotic medication costs during the first year after its launch, but the intensity of the impact differed between active substances. Furthermore, our results suggest that the additional cost savings from reference pricing after prior implemented generic substitution, are comparatively low.

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

Evaluation of 3D-Jury on CASP7 models.

PubMed

Kaján, László; Rychlewski, Leszek

2007-08-21

3D-Jury, the structure prediction consensus method publicly available in the Meta Server http://meta.bioinfo.pl/, was evaluated using models gathered in the 7th round of the Critical Assessment of Techniques for Protein Structure Prediction (CASP7). 3D-Jury is an automated expert process that generates protein structure meta-predictions from sets of models obtained from partner servers. The performance of 3D-Jury was analysed for three aspects. First, we examined the correlation between the 3D-Jury score and a model quality measure: the number of correctly predicted residues. The 3D-Jury score was shown to correlate significantly with the number of correctly predicted residues, the correlation is good enough to be used for prediction. 3D-Jury was also found to improve upon the competing servers' choice of the best structure model in most cases. The value of the 3D-Jury score as a generic reliability measure was also examined. We found that the 3D-Jury score separates bad models from good models better than the reliability score of the original server in 27 cases and falls short of it in only 5 cases out of a total of 38. We report the release of a new Meta Server feature: instant 3D-Jury scoring of uploaded user models. The 3D-Jury score continues to be a good indicator of structural model quality. It also provides a generic reliability score, especially important for models that were not assigned such by the original server. Individual structure modellers can also benefit from the 3D-Jury scoring system by testing their models in the new instant scoring feature http://meta.bioinfo.pl/compare_your_model_example.pl available in the Meta Server.

Evaluation of 3D-Jury on CASP7 models

PubMed Central

Kaján, László; Rychlewski, Leszek

2007-01-01

Background 3D-Jury, the structure prediction consensus method publicly available in the Meta Server , was evaluated using models gathered in the 7th round of the Critical Assessment of Techniques for Protein Structure Prediction (CASP7). 3D-Jury is an automated expert process that generates protein structure meta-predictions from sets of models obtained from partner servers. Results The performance of 3D-Jury was analysed for three aspects. First, we examined the correlation between the 3D-Jury score and a model quality measure: the number of correctly predicted residues. The 3D-Jury score was shown to correlate significantly with the number of correctly predicted residues, the correlation is good enough to be used for prediction. 3D-Jury was also found to improve upon the competing servers' choice of the best structure model in most cases. The value of the 3D-Jury score as a generic reliability measure was also examined. We found that the 3D-Jury score separates bad models from good models better than the reliability score of the original server in 27 cases and falls short of it in only 5 cases out of a total of 38. We report the release of a new Meta Server feature: instant 3D-Jury scoring of uploaded user models. Conclusion The 3D-Jury score continues to be a good indicator of structural model quality. It also provides a generic reliability score, especially important for models that were not assigned such by the original server. Individual structure modellers can also benefit from the 3D-Jury scoring system by testing their models in the new instant scoring feature available in the Meta Server. PMID:17711571

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

Global strategies to reduce the price of antiretroviral medicines: evidence from transactional databases.

PubMed

Waning, Brenda; Kaplan, Warren; King, Alexis C; Lawrence, Danielle A; Leufkens, Hubert G; Fox, Matthew P

2009-07-01

To estimate the impact of global strategies, such as pooled procurement arrangements, third-party price negotiation and differential pricing, on reducing the price of antiretrovirals (ARVs), which currently hinders universal access to HIV/AIDS treatment. We estimated the impact of global strategies to reduce ARV prices using data on 7253 procurement transactions (July 2002-October 2007) from databases hosted by WHO and the Global Fund to Fight AIDS, Tuberculosis and Malaria. For 19 of 24 ARV dosage forms, we detected no association between price and volume purchased. For the other five ARVs, high-volume purchases were 4-21% less expensive than medium- or low-volume purchases. Nine of 13 generic ARVs were priced 6-36% lower when purchased under the Clinton Foundation HIV/AIDS Initiative (CHAI). Fifteen of 18 branded ARVs were priced 23-498% higher for differentially priced purchases compared with non-CHAI generic purchases. However, two branded, differentially priced ARVs were priced 63% and 73% lower, respectively, than generic non-CHAI equivalents. Large purchase volumes did not necessarily result in lower ARV prices. Although current plans for pooled procurement will further increase purchase volumes, savings are uncertain and should be balanced against programmatic costs. Third-party negotiation by CHAI resulted in lower generic ARV prices. Generics were less expensive than differentially priced branded ARVs, except where little generic competition exists. Alternative strategies for reducing ARV prices, such as streamlining financial management systems, improving demand forecasting and removing barriers to generics, should be explored.

Health related quality of life in Mexican women with systemic lupus erythematosus: a descriptive study using SF-36 and LupusQoL(C).

PubMed

García-Carrasco, M; Mendoza-Pinto, C; Cardiel, M H; Méndez-Martínez, S; García-Villaseñor, A; Jiménez-Hernández, C; Alonso-García, N E; Briones-Rojas, R; Ramos-Álvarez, G; López-Colombo, A

2012-10-01

The LupusQoL© questionnaire is a disease-specific health related quality of life (HRQOL) instrument for adults with systemic lupus erythematosus (SLE). The Short Form-36 (SF-36) is a generic instrument that captures the physical, psychological, and social impact. We conducted a descriptive study of women aged ≥ 18 years attending our Lupus Clinic. HRQOL was assessed by applying the LupusQoL© and SF-36. Lupus activity was measured using the Mexican Systemic Lupus Erythematosus Disease Activity Index (Mex-SLEDAI) and chronic damage using the Systemic Lupus Collaborative Clinics Damage Index (SDI). Data were analyzed using descriptive statistics, the chi-square test and Pearson's product moment correlation coefficient. A total of 127 patients were included with a mean age of 40.5 ± 12.6 years. The mean disease duration was 8.2 ± 5.6 years, the mean disease activity score was 2.4 ± 3.0, and the mean SDI score 0.77 ± 1.06. The mean SF-36 score was 58.1 ± 21.1 and the mean LupusQoL© score was 69 ± 22.7. The correlation between global scores of the SF-36 and LupusQoL© was rho = 0.73 (p < 0.001). The correlation between lupus disease activity and the SF-36 and the LupusQoL© was -0.26 (p = 0.003) and -0.25 (p = 0.004), respectively. The correlation between the SDI and the SF-36 and the LupusQoL© was -0.28 (p = 0.001) and -0.38 (p < 0.0001), respectively. In conclusions: both LupusQoL© and SF-36 were useful instruments in assessing HRQOL in Mexican lupus female patients. The usefulness of the LupusQoL© should be evaluated in lupus patients with moderate to severe disease activity.

Applying Multi-Criteria Decision Analysis (MCDA) Simple Scoring as an Evidence-based HTA Methodology for Evaluating Off-Patent Pharmaceuticals (OPPs) in Emerging Markets.

PubMed

Brixner, Diana; Maniadakis, Nikos; Kaló, Zoltán; Hu, Shanlian; Shen, Jie; Wijaya, Kalman

2017-09-01

Off-patent pharmaceuticals (OPPs) represent more than 60% of the pharmaceutical market in many emerging countries, where they are frequently evaluated primarily on cost rather than with health technology assessment. OPPs are assumed to be identical to the originators. Branded and unbranded generic versions can, however, vary from the originator in active pharmaceutical ingredients, dosage, consistency formulation, excipients, manufacturing processes, and distribution, for example. These variables can alter the efficacy and safety of the product, negatively impacting both the anticipated cost savings and the population's health. In addition, many health care systems lack the resources or expertise to evaluate such products, and current assessment methods can be complex and difficult to adapt to a health system's needs. Multicriteria decision analysis (MCDA) simple scoring is an evidence-based health technology assessment methodology for evaluating OPPs, especially in emerging countries in which resources are limited but decision makers still must balance affordability with factors such as drug safety, level interchangeability, manufacturing site and active pharmaceutical ingredient quality, supply track record, and real-life outcomes. MCDA simple scoring can be applied to pharmaceutical pricing, reimbursement, formulary listing, and drug procurement. In November 2015, a workshop was held at the International Society for Pharmacoeconomics and Outcomes Research Annual Meeting in Milan to refine and prioritize criteria that can be used in MCDA simple scoring for OPPs, resulting in an example MCDA process and 22 prioritized criteria that health care systems in emerging countries can easily adapt to their own decision-making processes. Copyright © 2017 International Society for Pharmacoeconomics and Outcomes Research (ISPOR). Published by Elsevier Inc. All rights reserved.

The Dutch-Flemish PROMIS Physical Function item bank exhibited strong psychometric properties in patients with chronic pain.

PubMed

Crins, Martine H P; Terwee, Caroline B; Klausch, Thomas; Smits, Niels; de Vet, Henrica C W; Westhovens, Rene; Cella, David; Cook, Karon F; Revicki, Dennis A; van Leeuwen, Jaap; Boers, Maarten; Dekker, Joost; Roorda, Leo D

2017-07-01

The objective of this study was to assess the psychometric properties of the Dutch-Flemish Patient-Reported Outcomes Measurement Information System (PROMIS) Physical Function item bank in Dutch patients with chronic pain. A bank of 121 items was administered to 1,247 Dutch patients with chronic pain. Unidimensionality was assessed by fitting a one-factor confirmatory factor analysis and evaluating resulting fit statistics. Items were calibrated with the graded response model and its fit was evaluated. Cross-cultural validity was assessed by testing items for differential item functioning (DIF) based on language (Dutch vs. English). Construct validity was evaluated by calculation correlations between scores on the Dutch-Flemish PROMIS Physical Function measure and scores on generic and disease-specific measures. Results supported the Dutch-Flemish PROMIS Physical Function item bank's unidimensionality (Comparative Fit Index = 0.976, Tucker Lewis Index = 0.976) and model fit. Item thresholds targeted a wide range of physical function construct (threshold-parameters range: -4.2 to 5.6). Cross-cultural validity was good as four items only showed DIF for language and their impact on item scores was minimal. Physical Function scores were strongly associated with scores on all other measures (all correlations ≤ -0.60 as expected). The Dutch-Flemish PROMIS Physical Function item bank exhibited good psychometric properties. Development of a computer adaptive test based on the large bank is warranted. Copyright © 2017 Elsevier Inc. All rights reserved.

Intervening in the local health system to improve diabetes care: lessons from a health service experiment in a poor urban neighborhood in India.

PubMed

Bhojani, Upendra; Kolsteren, Patrick; Criel, Bart; De Henauw, Stefaan; Beerenahally, Thriveni S; Verstraeten, Roos; Devadasan, Narayanan

2015-01-01

Many efficacious health service interventions to improve diabetes care are known. However, there is little evidence on whether such interventions are effective while delivered in real-world resource-constrained settings. To evaluate an intervention aimed at improving diabetes care using the RE-AIM (reach, efficacy/effectiveness, adoption, implementation, and maintenance) framework. A quasi-experimental study was conducted in a poor urban neighborhood in South India. Four health facilities delivered the intervention (n=163 diabetes patients) and the four matched facilities served as control (n=154). The intervention included provision of culturally appropriate education to diabetes patients, use of generic medications, and standard treatment guidelines for diabetes management. Patients were surveyed before and after the 6-month intervention period. We did field observations and interviews with the doctors at the intervention facilities. Quantitative data were used to assess the reach of the intervention and its effectiveness on patients' knowledge, practice, healthcare expenditure, and glycemic control through a difference-in-differences analysis. Qualitative data were analyzed thematically to understand adoption, implementation, and maintenance of the intervention. Reach: Of those who visited intervention facilities, 52.3% were exposed to the education component and only 7.2% were prescribed generic medications. The doctors rarely used the standard treatment guidelines for diabetes management. The intervention did not have a statistically and clinically significant impact on the knowledge, healthcare expenditure, or glycemic control of the patients, with marginal reduction in their practice score. Adoption: All the facilities adopted the education component, while all but one facility adopted the prescription of generic medications. There was poor implementation of the intervention, particularly with regard to the use of generic medications and the standard treatment guidelines. Doctors' concerns about the efficacy, quality, availability, and acceptability by patients of generic medications explained limited prescriptions of generic medications. The patients' perception that ailments should be treated through medications limited the use of non-medical management by the doctors in early stages of diabetes. The other reason for the limited use of the standard treatment guidelines was that these doctors mainly provided follow-up care to patients who were previously put on a given treatment plan by specialists. Maintenance: The intervention facilities continued using posters and television monitors for health education after the intervention period. The use of generic medications and standard treatment guidelines for diabetes management remained very limited. Implementing efficacious health service intervention in a real-world resource-constrained setting is challenging and may not prove effective in improving patient outcomes. Interventions need to consider patients' and healthcare providers' experiences and perceptions and how macro-level policies translate into practice within local health systems.

Impact of Cost Sharing on Therapeutic Substitution: The Story of Statins in 2006.

PubMed

Li, Pengxiang; Schwartz, J Sanford; Doshi, Jalpa A

2016-11-11

Cost sharing is widely used to encourage therapeutic substitution. This study aimed to examine the impact of increases in patient cost-sharing differentials for brand name and generic drugs on statin utilization on entry into the Medicare Part D coverage gap. Using 5% Medicare Chronic Condition Warehouse files from 2006, this quasi-experimental study examined patients with hyperlipidemia who filled prescriptions for atorvastatin or rosuvastatin between January and March 2006. Propensity score matching and difference-in-difference regressions were used to compare changes in statin utilization for the study group (patients who were not eligible for low-income subsidies [non-LIS] and had generic-only gap coverage) to those of a control group (LIS patients who faced the same cost sharing before and during the Part D coverage gap). In the final sample, 801 patients in the study group were matched to 801 patients in the control group. We found that, compared to the control group, the study group had a larger decline in any monthly brand-name statin use (-0.24 30-day fills, P<0.001). This was only partially offset by increased monthly generic statin use (+0.06 30-day fill, P<0.001), with an overall drop in any monthly statin use (-0.18 30-day fills, P<0.001). Overall adherence with statins declined (OR 0.81, P<0.001), and statin discontinuation increased (OR 1.62, P<0.001) in the study group as compared to the control group. Increases in cost-sharing differentials for brand name and generic drugs on coverage gap entry were associated with discontinuation of statins in Medicare Part D patients with hyperlipidemia. © 2016 The Authors. Published on behalf of the American Heart Association, Inc., by Wiley Blackwell.

The Impact of Changes in Psoriasis Area and Severity Index by Body Region on Quality of Life in Patients with Psoriasis.

PubMed

Sojević Timotijević, Zorica; Majcan, Predrag; Trajković, Goran; Relić, Milijana; Novaković, Tatjana; Mirković, Momčilo; Djurić, Sladjana; Nikolić, Simon; Lazić, Bratislav; Janković, Slavenka

2017-10-01

Psoriasis severity varies by body region, with each affected region having a different impact on patient quality of life (QoL). The aim of this study was to assess the impact of changes in the Psoriasis Area and Severity Index (PASI) scores by body region on QoL in patients with psoriasis after treatment. A total of 100 patients with psoriasis were recruited to the study. All patients completed the generic EuroQol-5D instrument and two specific QoL measures, Dermatology Life Quality Index (DLQI) and Psoriasis Disability Index (PDI) at the beginning of the study, and 50 patients successfully completed the same questionnaires four weeks after the end of the treatment. Clinical severity was assessed using PASI total score and PASI body region (head, trunk, arms, and legs) scores. QoL improved after treatment, and PASI improvements on visible body regions (head, legs, and arms) showed significant correlation with the most sub-areas of the Visual Analog Scale (EQ VAS), DLQI, and PDI. Multiple linear regression analysis revealed that PASI improvement (particularly on the head), sex, age, and disease duration were predictors of QoL score changes for most domains of the three instruments. Improvement of psoriasis in visible body regions has an appreciable influence on QoL improvement, and may positively affect treatment success in patients with psoriasis.

A Automated Tool for Supporting FMEAs of Digital Systems

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

Yue,M.; Chu, T.-L.; Martinez-Guridi, G.

2008-09-07

Although designs of digital systems can be very different from each other, they typically use many of the same types of generic digital components. Determining the impacts of the failure modes of these generic components on a digital system can be used to support development of a reliability model of the system. A novel approach was proposed for such a purpose by decomposing the system into a level of the generic digital components and propagating failure modes to the system level, which generally is time-consuming and difficult to implement. To overcome the associated issues of implementing the proposed FMEA approach,more » an automated tool for a digital feedwater control system (DFWCS) has been developed in this study. The automated FMEA tool is in nature a simulation platform developed by using or recreating the original source code of the different module software interfaced by input and output variables that represent physical signals exchanged between modules, the system, and the controlled process. For any given failure mode, its impacts on associated signals are determined first and the variables that correspond to these signals are modified accordingly by the simulation. Criteria are also developed, as part of the simulation platform, to determine whether the system has lost its automatic control function, which is defined as a system failure in this study. The conceptual development of the automated FMEA support tool can be generalized and applied to support FMEAs for reliability assessment of complex digital systems.« less

Can generic paediatric mortality scores calculated 4 hours after admission be used as inclusion criteria for clinical trials?

PubMed Central

Leteurtre, Stéphane; Leclerc, Francis; Wirth, Jessica; Noizet, Odile; Magnenant, Eric; Sadik, Ahmed; Fourier, Catherine; Cremer, Robin

2004-01-01

Introduction Two generic paediatric mortality scoring systems have been validated in the paediatric intensive care unit (PICU). Paediatric RISk of Mortality (PRISM) requires an observation period of 24 hours, and PRISM III measures severity at two time points (at 12 hours and 24 hours) after admission, which represents a limitation for clinical trials that require earlier inclusion. The Paediatric Index of Mortality (PIM) is calculated 1 hour after admission but does not take into account the stabilization period following admission. To avoid these limitations, we chose to conduct assessments 4 hours after PICU admission. The aim of the present study was to validate PRISM, PRISM III and PIM at the time points for which they were developed, and to compare their accuracy in predicting mortality at those times with their accuracy at 4 hours. Methods All children admitted from June 1998 to May 2000 in one tertiary PICU were prospectively included. Data were collected to generate scores and predictions using PRISM, PRISM III and PIM. Results There were 802 consecutive admissions with 80 deaths. For the time points for which the scores were developed, observed and predicted mortality rates were significantly different for the three scores (P < 0.01) whereas all exhibited good discrimination (area under the receiver operating characteristic curve ≥0.83). At 4 hours after admission only the PIM had good calibration (P = 0.44), but all three scores exhibited good discrimination (area under the receiver operating characteristic curve ≥0.82). Conclusions Among the three scores calculated at 4 hours after admission, all had good discriminatory capacity but only the PIM score was well calibrated. Further studies are required before the PIM score at 4 hours can be used as an inclusion criterion in clinical trials. PMID:15312217

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.

Assessing Impact of Distributions and Dependencies in Analysis of Alternatives of System of Systems: Phase 3

DTIC Science & Technology

2013-12-19

32 3.3 An Approach for Evaluating System-of-Systems Operational Benefits of a...delay of a flight under IMC ............................................... 41 Figure 15: Sensitivity of delay of each of the four segments to...85 Figure 43: Generic SoS node behaviors

Estimation of a Preference-Based Summary Score for the Patient-Reported Outcomes Measurement Information System: The PROMIS®-Preference (PROPr) Scoring System.

PubMed

Dewitt, Barry; Feeny, David; Fischhoff, Baruch; Cella, David; Hays, Ron D; Hess, Rachel; Pilkonis, Paul A; Revicki, Dennis A; Roberts, Mark S; Tsevat, Joel; Yu, Lan; Hanmer, Janel

2018-06-01

Health-related quality of life (HRQL) preference-based scores are used to assess the health of populations and patients and for cost-effectiveness analyses. The National Institutes of Health Patient-Reported Outcomes Measurement Information System (PROMIS ® ) consists of patient-reported outcome measures developed using item response theory. PROMIS is in need of a direct preference-based scoring system for assigning values to health states. To produce societal preference-based scores for 7 PROMIS domains: Cognitive Function-Abilities, Depression, Fatigue, Pain Interference, Physical Function, Sleep Disturbance, and Ability to Participate in Social Roles and Activities. Online survey of a US nationally representative sample ( n = 983). Preferences for PROMIS health states were elicited with the standard gamble to obtain both single-attribute scoring functions for each of the 7 PROMIS domains and a multiplicative multiattribute utility (scoring) function. The 7 single-attribute scoring functions were fit using isotonic regression with linear interpolation. The multiplicative multiattribute summary function estimates utilities for PROMIS multiattribute health states on a scale where 0 is the utility of being dead and 1 the utility of "full health." The lowest possible score is -0.022 (for a state viewed as worse than dead), and the highest possible score is 1. The online survey systematically excludes some subgroups, such as the visually impaired and illiterate. A generic societal preference-based scoring system is now available for all studies using these 7 PROMIS health domains.

Price regulation and generic competition in the pharmaceutical market.

PubMed

Dalen, Dag Morten; Strøm, Steinar; Haabeth, Tonje

2006-09-01

In March 2003 the Norwegian government implemented yardstick-based price regulation schemes on a selection of drugs subjected to generic competition. The retail price cap, termed the "index price," on a drug (chemical substance) was set equal to the average of the three lowest producer prices on that drug, plus a fixed wholesale and retail margin. This is supposed to lower barriers of entry for generic drugs and to trigger price competition. Using monthly data over the period 1998-2004 for the six drugs (chemical entities) included in the index price system, we estimate a structural model enabling us to examine the impact of the reform on both demand and market power. Our results suggest that the index price helped to increase the market shares of generic drugs and succeeded in triggering price competition.

Brand vs generic adverse event reporting patterns: An authorized generic-controlled evaluation of cardiovascular medications.

PubMed

Alatawi, Y; Rahman, Md M; Cheng, N; Qian, J; Peissig, P L; Berg, R L; Page, C D; Hansen, R A

2018-06-01

Some public scepticism exists about generics in terms of whether brand and generic drugs produce identical outcomes. This study explores whether adverse event (AE) reporting patterns are similar between brand and generic drugs, using authorized generics (AGs) as a control for possible generic drug perception biases. Events reported to the FDA Adverse Event Reporting System from the years 2004-2015 were analysed. Drugs were classified as brand, AG or generic based on drug and manufacturer names. Reports were included if amlodipine, losartan, metoprolol extended release (ER) or simvastatin were listed as primary or secondary suspect drugs. Disproportionality analyses using the reporting odds ratio (ROR) assessed the relative rate of reporting labelled AEs compared to reporting these AEs with all other drugs. The Breslow-Day test compared RORs across brand, AG and generic. Interrupted time series analysis evaluated the impact of generic entry on reporting trends. Generics accounted for significant percentages of total U.S. reports, but AGs accounted for smaller percentages of reports, including for amlodipine (14.26%), losartan (1.48%), metoprolol ER (0.35%) and simvastatin (0.70%). Whereas the RORs were significantly different for multiple brand vs generic comparisons, the AG vs generic comparisons yielded fewer statistically significant findings. Namely, only the ROR for AG differed from generic for amlodipine with peripheral oedema (P < .01). Inconsistent reporting patterns were observed more between brand and generic compared with AG and generic. Use of AGs as a control for perception biases against generics is useful, but this approach can be limited by small AG report numbers. Requiring the manufacturer name to be printed on the prescription bottle or packaging could improve the accuracy of assignment for products being reported. © 2017 John Wiley & Sons Ltd.

ENTRY IN THE ADHD DRUGS MARKET: WELFARE IMPACT OF GENERICS AND ME-TOO'S*

PubMed Central

Bokhari, Farasat A S; Fournier, Gary M

2013-01-01

Recent decades have seen a growth in treatments for attention deficit hyperactivity disorder (ADHD) including many branded and generic drugs. In the early 2000's, new drug entry dramatically altered market shares. We estimate a demand system for ADHD drugs and assess the welfare impact of new drugs. We find that entry induced large welfare gains by reducing prices of substitute drugs, and by providing alternative delivery mechanisms for existing molecules. Our results suggest that the success of follow-on patented drugs may come from unanticipated innovations like delivery mechanisms, a factor ignored by proposals to retard new follow-on drug approvals. PMID:25821242

A Generic Modeling Process to Support Functional Fault Model Development

NASA Technical Reports Server (NTRS)

Maul, William A.; Hemminger, Joseph A.; Oostdyk, Rebecca; Bis, Rachael A.

2016-01-01

Functional fault models (FFMs) are qualitative representations of a system's failure space that are used to provide a diagnostic of the modeled system. An FFM simulates the failure effect propagation paths within a system between failure modes and observation points. These models contain a significant amount of information about the system including the design, operation and off nominal behavior. The development and verification of the models can be costly in both time and resources. In addition, models depicting similar components can be distinct, both in appearance and function, when created individually, because there are numerous ways of representing the failure space within each component. Generic application of FFMs has the advantages of software code reuse: reduction of time and resources in both development and verification, and a standard set of component models from which future system models can be generated with common appearance and diagnostic performance. This paper outlines the motivation to develop a generic modeling process for FFMs at the component level and the effort to implement that process through modeling conventions and a software tool. The implementation of this generic modeling process within a fault isolation demonstration for NASA's Advanced Ground System Maintenance (AGSM) Integrated Health Management (IHM) project is presented and the impact discussed.

Potential impact of policy regulation and generic competition on sales of cholesterol lowering medication, antidepressants and acid blocking agents in Belgium.

PubMed

Fraeyman, J; Van Hal, G; De Loof, H; Remmen, R; De Meyer, G R Y; Beutels, P

2012-01-01

Pharmaceutical expenditures are increasing as a proportion of health expenditures in most rich countries. Antidepressants, acid blocking agents and cholesterol lowering medication are major contributors to medicine sales around the globe. We aimed to document the possible impact of policy regulations and generic market penetration on the evolution of sales volume and average cost per unit (Defined Daily Doses and packages) of antidepressants, acid blocking agents and cholesterol lowering medication. We extracted data from the IMS health database regarding the public price and sales volume of the antidepressants (selective serotonin reuptake inhibitors (SSRI's), monoamine oxidase inhibitors (MAOl's) and tricyclic and remaining antidepressants (TCA's)), acid blocking agents (proton pump inhibitors (PPl's) and H2 receptor antagonists) and cholesterol lowering medication (statins and fibrates) in Belgium between 1995 and 2009. We describe these sales data in relation to various national policy measures which were systematically searched in official records. Our analysis suggests that particular policy regulations have had immediate impact on sales figures and expenditures on pharmaceuticals in Belgium: changes in reimbursement conditions, a public tender and entry of generic competitors in a reference pricing system. However, possible sustainable effects seem to be counteracted by other mechanisms such as marketing strategies, prescribing behaviour, brand loyalty and the entry of pseudogenerics. It is likely that demand-side measures have a more sustainable impact on expenditure. Compared with other European countries, generic penetration in Belgium remains low. Alternative policy regulations aimed at enlarging the generic market and influencing pharmaceutical expenditures deserve consideration. This should include policies aiming to influence physicians' prescribing and a shared responsibility of pharmacists, physicians and patients towards expenditures.

How Do Generic Statements Impact Performance? Evidence for Entity Beliefs

ERIC Educational Resources Information Center

Park, Daeun; Schaeffer, Marjorie W.; Nolla, Kyle M.; Levine, Susan C.; Beilock, Sian L.

2017-01-01

Generic statements about the abilities of children's social groups (e.g. "Girls/Boys are good at this game") negatively impact children's performance--even if the statements are favorable towards children's own social groups. We explored the mechanism by which generic language impairs children's performance. Across three studies, our…

Global strategies to reduce the price of antiretroviral medicines: evidence from transactional databases

PubMed Central

Kaplan, Warren; King, Alexis C; Lawrence, Danielle A; Leufkens, Hubert G; Fox, Matthew P

2009-01-01

Abstract Objective To estimate the impact of global strategies, such as pooled procurement arrangements, third-party price negotiation and differential pricing, on reducing the price of antiretrovirals (ARVs), which currently hinders universal access to HIV/AIDS treatment. Methods We estimated the impact of global strategies to reduce ARV prices using data on 7253 procurement transactions (July 2002–October 2007) from databases hosted by WHO and the Global Fund to Fight AIDS, Tuberculosis and Malaria. Findings For 19 of 24 ARV dosage forms, we detected no association between price and volume purchased. For the other five ARVs, high-volume purchases were 4–21% less expensive than medium- or low-volume purchases. Nine of 13 generic ARVs were priced 6–36% lower when purchased under the Clinton Foundation HIV/AIDS Initiative (CHAI). Fifteen of 18 branded ARVs were priced 23–498% higher for differentially priced purchases compared with non-CHAI generic purchases. However, two branded, differentially priced ARVs were priced 63% and 73% lower, respectively, than generic non-CHAI equivalents. Conclusion Large purchase volumes did not necessarily result in lower ARV prices. Although current plans for pooled procurement will further increase purchase volumes, savings are uncertain and should be balanced against programmatic costs. Third-party negotiation by CHAI resulted in lower generic ARV prices. Generics were less expensive than differentially priced branded ARVs, except where little generic competition exists. Alternative strategies for reducing ARV prices, such as streamlining financial management systems, improving demand forecasting and removing barriers to generics, should be explored. PMID:19649366

Topical Trends in a Corpus of Persuasive Writing. Research Report. ETS RR-12-19

ERIC Educational Resources Information Center

Heilman, Michael; Madnani, Nitin

2012-01-01

Many writing assessments use generic prompts about social issues. However, we currently lack an understanding of how test takers respond to such prompts. In the absence of such an understanding, automated scoring systems may not be as reliable as they could be and may worsen over time. To move toward a deeper understanding of responses to generic…

Analysis of medical screening and surveillance in 21 Occupational Safety and Health Administration standards: support for a generic medical surveillance standard.

PubMed

Silverstein, M

1994-09-01

Twenty-one Occupational Safety and Health Act (OSHA) standards were identified which contain medical service provisions intended to help in the identification and control of harmful health effects of workplace exposures. The utility and effectiveness of these provisions have not previously been evaluated. All 21 standards were reviewed and assigned numerical scores for each of 24 potential medical program elements. Several of these elements were combined to calculate Quality Control, Screening Utility, and Surveillance Utility scores for each standard. Total scores varied greatly, suggesting a lack of consistency and uniformity which was even more obvious when the actual regulatory language was examined. The mean Quality score was only 26% of potential points. Seventeen of 21 standards received less than half the total possible Quality score. When arrayed on a two by two matrix only two standards scored above 50% for both Screening and Surveillance Utility. It was concluded that the medical service provisions in OSHA standards are lacking in consistency and coherence. Two major shortcomings are the lack of quality control elements and the absence of surveillance features which would permit medical program results to be utilized for prevention activities including the identification and control of workplace hazards. A generic occupational medical surveillance standard could address these current weaknesses. Elements of such a generic standard are proposed.

Investigation of the efficacy of generic and brand-name tiotropium bromide in the management of chronic obstructive pulmonary disease: A randomized comparative trial.

PubMed

Panahi, Yunes; Ghanei, Mostafa; Behzadi, Mohammad; Salehi, Maryam; Soflaei, Sara Saffar; Sahebkar, Amirhossein

2016-03-01

The beneficial effects of tiotropium bromide, a long acting anticholinergic bronchodilator, in the management of chronic obstructive pulmonary disease have been shown in previous studies. The present study aimed to compare the efficacy and safety of generic (Tiova®) and brand-name (Spiriva®) tiotropium preparations in patients with COPD. In this randomized double-blind parallel-group trial, 79 patients with documented COPD were assigned to Tiova® or Spiriva® for a period of 4 weeks. Assessment of pulmonary function (using spirometry), quality-of-life (using St. George respiratory Questionnaire [SGRQ]) and severity of respiratory symptoms (using breathlessness, cough and sputum scale [BCSS]) was performed at baseline and at the end of treatment period. There were significant increases in FEV1 and reductions in FVC by the end of study in both Tiova® and Spiriva® groups. FEV1/FVC ratio did not change significantly neither in the Tiova® nor in Spiriva® group. Overall SGRQ score as well as subscale scores of symptoms, activity and impacts were improved by both drugs. In the BCSS scale, the frequency and severity of three main symptoms (dyspnea, cough and sputum) was decreased by both drugs. Baseline as well as post-treatment values of spirometric parameters, SGRQ and BCSS scores was comparable between the groups, apart from a lower post-treatment frequency of cough and sputum in the Spiriva® versus Tiova® group. There was no report of adverse events in either of the study groups. The findings of this comparative trial showed equivalent efficacy and safety of Spiriva® and Tiova® in lessening the symptoms as well as improving the quality of life in patients with COPD. This finding has an important translational value given the significantly lower costs of generic versus brand-name products.

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.

Pilot Validation Study of the European Association of Urology Robotic Training Curriculum.

PubMed

Volpe, Alessandro; Ahmed, Kamran; Dasgupta, Prokar; Ficarra, Vincenzo; Novara, Giacomo; van der Poel, Henk; Mottrie, Alexandre

2015-08-01

The development of structured and validated training curricula is one of the current priorities in robot-assisted urological surgery. To establish the feasibility, acceptability, face validity, and educational impact of a structured training curriculum for robot-assisted radical prostatectomy (RARP), and to assess improvements in performance and ability to perform RARP after completion of the curriculum. A 12-wk training curriculum was developed based on an expert panel discussion and used to train ten fellows from major European teaching institutions. The curriculum included: (1) e-learning, (2) 1 wk of structured simulation-based training (virtual reality synthetic, animal, and cadaveric platforms), and (3) supervised modular training for RARP. The feasibility, acceptability, face validity, and educational impact were assessed using quantitative surveys. Improvement in the technical skills of participants over the training period was evaluated using the inbuilt validated assessment metrics on the da Vinci surgical simulator (dVSS). A final RARP performed by fellows on completion of their training was assessed using the Global Evaluative Assessment of Robotic Skills (GEARS) score and generic and procedure-specific scoring criteria. The median baseline experience of participants as console surgeon was 4 mo (interquartile range [IQR] 0-6.5 mo). All participants completed the curriculum and were involved in a median of 18 RARPs (IQR 14-36) during modular training. The overall score for dVSS tasks significantly increased over the training period (p<0.001-0.005). At the end of the curriculum, eight fellows (80%) were deemed able by their mentors to perform a RARP independently, safely, and effectively. At assessment of the final RARP, the participants achieved an average score ≥4 (scale 1-5) for all domains using the GEARS scale and an average score >10 (scale 4-16) for all procedural steps using a generic dedicated scoring tool. In performance comparison using this scoring tool, the experts significantly outperformed the fellows (mean score for all steps 13.6 vs 11). The European robot-assisted urologic training curriculum is acceptable, valid, and effective for training in RARP. This study shows that a 12-wk structured training program including simulation-based training and mentored training in the operating room allows surgeons with limited robotic experience to increase their robotic skills and their ability to perform the surgical steps of robot-assisted radical prostatectomy. Copyright © 2014 European Association of Urology. Published by Elsevier B.V. All rights reserved.

Improvement in Generic Problem-Solving Abilities of Students by Use of Tutor-less Problem-Based Learning in a Large Classroom Setting

PubMed Central

Klegeris, Andis; Bahniwal, Manpreet; Hurren, Heather

2013-01-01

Problem-based learning (PBL) was originally introduced in medical education programs as a form of small-group learning, but its use has now spread to large undergraduate classrooms in various other disciplines. Introduction of new teaching techniques, including PBL-based methods, needs to be justified by demonstrating the benefits of such techniques over classical teaching styles. Previously, we demonstrated that introduction of tutor-less PBL in a large third-year biochemistry undergraduate class increased student satisfaction and attendance. The current study assessed the generic problem-solving abilities of students from the same class at the beginning and end of the term, and compared student scores with similar data obtained in three classes not using PBL. Two generic problem-solving tests of equal difficulty were administered such that students took different tests at the beginning and the end of the term. Blinded marking showed a statistically significant 13% increase in the test scores of the biochemistry students exposed to PBL, while no trend toward significant change in scores was observed in any of the control groups not using PBL. Our study is among the first to demonstrate that use of tutor-less PBL in a large classroom leads to statistically significant improvement in generic problem-solving skills of students. PMID:23463230

Context factors in general practitioner-patient encounters and their impact on assessing communication skills--an exploratory study.

PubMed

Essers, Geurt; Kramer, Anneke; Andriesse, Boukje; van Weel, Chris; van der Vleuten, Cees; van Dulmen, Sandra

2013-05-22

Assessment of medical communication performance usually focuses on rating generically applicable, well-defined communication skills. However, in daily practice, communication is determined by (specific) context factors, such as acquaintance with the patient, or the presented problem. Merely valuing the presence of generic skills may not do justice to the doctor's proficiency.Our aim was to perform an exploratory study on how assessment of general practitioner (GP) communication performance changes if context factors are explicitly taken into account. We used a mixed method design to explore how ratings would change. A random sample of 40 everyday GP consultations was used to see if previously identified context factors could be observed again. The sample was rated twice using a widely used assessment instrument (the MAAS-Global), first in the standard way and secondly after context factors were explicitly taken into account, by using a context-specific rating protocol to assess communication performance in the workplace. In between first and second rating, the presence of context factors was established. Item score differences were calculated using paired sample t-tests. In 38 out of 40 consultations, context factors prompted application of the context-specific rating protocol. Mean overall score on the 7-point MAAS-Global scale increased from 2.98 in standard to 3.66 in the context-specific rating (p<0.00); the effect size for the total mean score was 0.84. In earlier research the minimum standard score for adequate communication was set at 3.17. Applying the protocol, the mean overall score rose above the level set in an earlier study for the MAAS-Global scores to represent 'adequate GP communication behaviour'. Our findings indicate that incorporating context factors in communication assessment thus makes a meaningful difference and shows that context factors should be considered as 'signal' instead of 'noise' in GP communication assessment. Explicating context factors leads to a more deliberate and transparent rating of GP communication performance.

Fatigue and health related quality of life in children and adolescents with cancer.

PubMed

Nunes, Michelle Darezzo Rodrigues; Jacob, Eufemia; Bomfim, Emiliana Omena; Lopes-Junior, Luis Carlos; de Lima, Regina Aparecida Garcia; Floria-Santos, Milena; Nascimento, Lucila Castanheira

2017-08-01

The study examined the different dimensions of fatigue (general, sleep/rest, cognitive), health related quality of life (HRQL) (physical, emotional, cognitive, social), and the relationships between fatigue and HRQL in hospitalized children and adolescents with cancer in Brazil. Participants were recruited from a pediatric oncology inpatient unit in a comprehensive cancer care hospital in southeast Brazil. They completed the PedsQL Multidimensional Fatigue Scale and the PedsQL Inventory of Quality of Life (Generic and Cancer module) once during hospitalization. The majority (66.7%) of the participants (n = 38; mean age 12.1 ± 2.9 years) had total fatigue scores < 75 on 0 to 100 scale; with the mean total fatigue score of 63.8 ± 18.5. The majority (72.2% generic; 83.3% cancer modules) had total PedsQL scores < 75 on 0 to 100 scale. The mean PedsQL score on generic module (61.1 ± 17.0) was similar to the mean PedsQL score cancer module (59.1 ± 16.7). Significant correlations were found between total fatigue and quality of life generic (r = 0.63, p = 0.000) and cancer module (r = 0.74, p = 0.000). The study is the first to report fatigue and health related quality of life in hospitalized children and adolescents with cancer in Brazil. Similar to experiences of other children in the world, our findings indicate that children and adolescents with cancer had problems with fatigue that were associated with low HRQL. Future studies are recommended to examine interventions (exercise, leisurely activities) that may alleviate fatigue and improve HRQL in pediatric patients with cancer. Copyright © 2017 Elsevier Ltd. All rights reserved.

Space platform utilities distribution study

NASA Technical Reports Server (NTRS)

Lefever, A. E.

1980-01-01

Generic concepts for the installation of power data and thermal fluid distribution lines on large space platforms were discussed. Connections with central utility subsystem modules and pallet interfaces were also considered. Three system concept study platforms were used as basepoints for the detail development. The tradeoff of high voltage low voltage power distribution and the impact of fiber optics as a data distribution mechanism were analyzed. Thermal expansion and temperature control of utility lines and ducts were considered. Technology developments required for implementation of the generic distribution concepts were identified.

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

Daling, P.M.; Marler, J.E.; Vo, T.V.

This study evaluates the values (benefits) and impacts (costs) associated with potential resolutions to Generic Issue 143, ``Availability of HVAC and Chilled Water Systems.`` The study identifies vulnerabilities related to failures of HVAC, chilled water, and room cooling systems; develops estimates of room heatup rates and safety-related equipment vulnerabilities following losses of HVAC/room cooler systems; develops estimates of the core damage frequencies and public risks associated with failures of these systems; develops three proposed resolution strategies to this generic issue; and performs a value/impact analysis of the proposed resolutions. Existing probabilistic risk assessments for four representative plants, including one plantmore » from each vendor, form the basis for the core damage frequency and public risk calculations. Both internal and external events were considered. It was concluded that all three proposed resolution strategies exceed the $1,000/person-rem cost-effectiveness ratio. Additional evaluations were performed to develop ``generic`` insights on potential design-related and configuration-related vulnerabilities and potential high-frequency ({approximately}1E-04/RY) accident sequences that involve failures of HVAC/room cooling functions. It was concluded that, although high-frequency accident sequences may exist at some plants, these high-frequency sequences are plant-specific in nature or have been resolved through hardware and/or operational changes. The plant-specific Individual Plant Examinations are an effective vehicle for identification and resolution of these plant-specific anomalies and hardware configurations.« less

Evaluation of health related quality of life in children with immune thrombocytopenia with the PedsQL™ 4.0 Generic Core Scales: a study on behalf of the pays de Loire pediatric hematology network.

PubMed

Strullu, Marion; Rakotonjanahary, Josué; Tarral, Eliane; Savagner, Christophe; Thomas, Caroline; Méchinaud, Françoise; Reguerre, Yves; Poignant, Sylvaine; Boutet, Arnaud; Bassil, Joachim; Médinger, Dominique; Quemener, Emmanuel; Young, Nancy L; Rachieru, Petronela; Klaassen, Robert J; Pellier, Isabelle

2013-11-13

Immune thrombocytopenia (ITP) is a childhood disorder that is often life-altering for children and their parents. Health related quality of life (HRQL) has never been chronologically monitored in children with ITP. We initiated a prospective study to assess HRQL from diagnosis to six months and define factors that influence this outcome in children with ITP. 73 children with acute ITP aged from 2 to 18 years were prospectively enrolled in the study. According to the presence of bleeding, they were or were not given a 4-day course of corticosteroid treatment. The PedsQL™ 4.0 Generic Core Scale was completed by children and parents upon their inclusion in the study and 6 months after diagnosis. Over the six month period, quality of life improved in terms of their global, physical and psychosocial well-being for 54.5%, 35.6% and 36.2% of patients respectively. This improvement is clinically relevant compared to scores at diagnosis, corresponding at least to a minimal clinically important difference (MCID). Factors such as sex, age, platelet count, bleeding scores, bone marrow aspiration and persistence of ITP at 6 months were not significantly associated with HRQL scores. However, preceding viral infection was identified to have an impact on HRQL. This first longitudinal study assessing HRQL in children with ITP reveals a global improvement in PedSQL™ 4.0. However, these results should be considered with caution since our data also confirm that self-report HRQL scores are not influenced by any analyzed biologic or clinical parameters. Others tools, such as Kids' ITP Tools, would probably be required to assess the HRQL of this population. Trial registration clinical trials.gov Identifier: NCT00331357.

Some design constraints required for the assembly of software components: The incorporation of atomic abstract types into generically structured abstract types

NASA Technical Reports Server (NTRS)

Johnson, Charles S.

1986-01-01

It is nearly axiomatic, that to take the greatest advantage of the useful features available in a development system, and to avoid the negative interactions of those features, requires the exercise of a design methodology which constrains their use. A major design support feature of the Ada language is abstraction: for data, functions processes, resources, and system elements in general. Atomic abstract types can be created in packages defining those private types and all of the overloaded operators, functions, and hidden data required for their use in an application. Generically structured abstract types can be created in generic packages defining those structured private types, as buildups from the user-defined data types which are input as parameters. A study is made of the design constraints required for software incorporating either atomic or generically structured abstract types, if the integration of software components based on them is to be subsequently performed. The impact of these techniques on the reusability of software and the creation of project-specific software support environments is also discussed.

76 FR 37160 - Notice of Availability of Final Supplemental Environmental Impact Statement for the Lost Creek In...

Federal Register 2010, 2011, 2012, 2013, 2014

2011-06-24

... Environmental Impact Statement for the Lost Creek In-Situ Recovery (ISR) Project in Sweetwater County, WY; Supplement to the Generic Environmental Impact Statement for In-Situ Leach Uranium Milling Facilities AGENCY... Statement (SEIS) to the Generic Environmental Impact Statement for In- Situ Leach Uranium Milling Facilities...

Nurses caring for ENT patients in a district general hospital without a dedicated ENT ward score significantly less in a test of knowledge than nurses caring for ENT patients in a dedicated ENT ward in a comparable district general hospital.

PubMed

Foxton, C R; Black, D; Muhlschlegel, J; Jardine, A

2014-12-01

To assess whether there is a difference in ENT knowledge amongst nurses caring for patients on a dedicated ENT ward and nurses caring for ENT patients in a similar hospital without a dedicated ENT ward. A test of theoretical knowledge of ENT nursing care was devised and administered to nurses working on a dedicated ENT ward and then to nurses working on generic non-subspecialist wards regularly caring for ENT patients in a hospital without a dedicated ENT ward. The test scores were then compared. A single specialist ENT/Maxillo-Facial/Opthalmology ward in hospital A and 3 generic surgical wards in hospital B. Both hospitals are comparable district general hospitals in the south west of England. Nursing staff working in hospital A and hospital B on the relevant wards were approached during the working day. 11 nurses on ward 1, 10 nurses on ward 2, 11 nurses on ward 3 and 10 nurses on ward 4 (the dedicated ENT ward). Each individual test score was used to generate an average score per ward and these scores compared to see if there was a significant difference. The average score out of 10 on ward 1 was 6.8 (+/-1.6). The average score on ward two was 4.8 (+/-1.6). The average score on ward three was 5.5 (+/-2.1). The average score on ward 4, which is the dedicated ENT ward, was 9.7 (+/-0.5). The differences in average test score between the dedicated ENT ward and all of the other wards are statistically significant. Nurses working on a dedicated ENT ward have an average higher score in a test of knowledge than nurses working on generic surgical wards. This difference is statistically significant and persists despite banding or training. © 2014 John Wiley & Sons Ltd.

Systematic review of the impact of urinary tract infections on health-related quality of life.

PubMed

Bermingham, Sarah L; Ashe, Joanna F

2012-12-01

What's known on the subject? and What does the study add? Values for equivalent health states can vary substantially depending on the measure used and method of valuation; this has a direct impact on the results of economic analyses. To date, the majority of existing economic evaluations that include UTI as a health state refer to an analysis in which the Index of Well Being was used to estimate the quality of life experienced by young women with UTIs. Currently, there are no validated methods or filters for systematically searching for the type of generic quality of life data required for decision analytic models. This study is the only systematic review of quality of life in people with UTI in the literature. Twelve studies were identified which report quality of life using a variety of generic methods; the results of these papers were summarized in a way that is useful for a health researcher seeking to populate a decision model, design a clinical study or assess the effect of UTI on quality of life relative to other conditions. One research group provided previously unpublished data from a large cohort study; these scores were mapped to EuroQol 5-Dimension values using published algorithms and probabilistic simulations. The aim of this review was to identify studies that have evaluated the impact of symptomatic urinary tract infection (UTI) and UTI-associated bacteraemia on quality of life, and to summarize these data in a way that is useful for a health researcher seeking to populate a cost-utility model, design a clinical study or assess the effect of UTIs on quality of life relative to other conditions. We conducted a systematic search of the literature using MEDLINE, EMBASE, the NHS Economic Evaluations database, Health Technology Assessment database, Health Economics Evaluations database, Cost-Effectiveness Analysis Registry and EuroQol website. Studies that reported utility values for symptomatic UTI or UTI-associated bacteraemia derived from a generic QoL measurement tool or expert opinion were included. Studies using disease-specific instruments were excluded. Twelve studies were identified that included a generic measure of health-related quality of life for patients with UTIs. These measures included: the short-form (SF)-36 and SF-12 questionnaires; the Health Utilities Index Mark 2; Quality of Well Being; the Index of Well Being, standard gamble; the Health and Activity Limitation Index; and expert opinion. The authors of studies using either of the SF questionnaires were contacted for additional data. One research group provided previously unpublished data from a large cohort study; these scores were mapped to EuroQol 5-Dimension (EQ-5D) values using published algorithms and probabilistic simulations. The present review provides health researchers with several sources from which to select utility values to populate cost-utility models. It also shows that very few studies have measured quality of life in patients with UTI using generic preference-based measures of health and none have evaluated the impact of this health state on quality of life in children. Future studies ought to consider the inclusion of commonly used preference-based measures of health, such as the EQ-5D, in all patient populations experiencing symptomatic UTI or UTI-related complications. © 2012 NATIONAL CLINICAL GUIDELINE CENTRE OF ROYAL COLLEGE OF PHYSICIANS.

Video Discs in Libraries.

ERIC Educational Resources Information Center

Barker, Philip

1986-01-01

Discussion of developments in information storage technology likely to have significant impact upon library utilization focuses on hardware (videodisc technology) and software developments (knowledge databases; computer networks; database management systems; interactive video, computer, and multimedia user interfaces). Three generic computer-based…

The impact of disease duration on quality of life in children with nephrotic syndrome: a Midwest Pediatric Nephrology Consortium study.

PubMed

Selewski, David T; Troost, Jonathan P; Massengill, Susan F; Gbadegesin, Rasheed A; Greenbaum, Larry A; Shatat, Ibrahim F; Cai, Yi; Kapur, Gaurav; Hebert, Diane; Somers, Michael J; Trachtman, Howard; Pais, Priya; Seifert, Michael E; Goebel, Jens; Sethna, Christine B; Mahan, John D; Gross, Heather E; Herreshoff, Emily; Liu, Yang; Song, Peter X; Reeve, Bryce B; DeWalt, Darren A; Gipson, Debbie S

2015-09-01

The Patient Reported Outcomes Measurement Information System (PROMIS) II is a prospective study that evaluates patient reported outcomes in pediatric chronic diseases as a measure of health-related quality of life (HRQOL). We have evaluated the influence of disease duration on HRQOL and, for the first time, compared the findings of the PROMIS measures to those of the PedsQL™ 4.0 Generic Scales (PedsQL) from the PROMIS II nephrotic syndrome (NS) longitudinal cohort. This was a prospective study in which 127 children (age range 8-17 years) with active NS from 14 centers were enrolled. Children with active NS defined as the presence of nephrotic range proteinuria (>2+ urinalysis and edema or urine protein/creatinine ratio >2 g/g) were eligible. Comparisons were made between children with prevalent (N = 67) and incident (N = 60) disease at the study enrollment visit. The PROMIS scores were worse in prevalent patients in the domains of peer relationship (p = 0.01) and pain interference (p < 0.01). The PedsQL showed worse scores in prevalent patients for social functioning (p < 0.01) and school functioning (p = 0.03). Multivariable analyses showed that prevalent patients had worse scores in PROMIS pain interference (p = 0.02) and PedsQL social functioning (p < 0.01). The PROMIS measures detected a significant impact of disease duration on HRQOL in children, such that peer relationships were worse and pain interfered with daily life to a greater degree among those with longer disease duration. These findings were in agreement with those for similar domains in the PedsQL legacy instrument.

The impact of disease duration on quality of life in children with nephrotic syndrome: a Midwest Pediatric Nephrology Consortium study

PubMed Central

Troost, Jonathan P.; Massengill, Susan F.; Gbadegesin, Rasheed A.; Greenbaum, Larry A.; Shatat, Ibrahim F.; Cai, Yi; Kapur, Gaurav; Hebert, Diane; Somers, Michael J.; Trachtman, Howard; Pais, Priya; Seifert, Michael E.; Goebel, Jens; Sethna, Christine B.; Mahan, John D.; Gross, Heather E.; Herreshoff, Emily; Liu, Yang; Song, Peter X.; Reeve, Bryce B.; DeWalt, Darren A.; Gipson, Debbie S.

2015-01-01

Background The Patient Reported Outcomes Measurement Information System (PROMIS) II is a prospective study that evaluates patient reported outcomes in pediatric chronic diseases as a measure of health-related quality of life (HRQOL). We have evaluated the influence of disease duration on HRQOL and, for the first time, compared the findings of the PROMIS measures to those of the PedsQL™ 4.0 Generic Scales (PedsQL) from the PROMIS II nephrotic syndrome (NS) longitudinal cohort. Methods This was a prospective study in which 127 children (age range 8–17 years) with active NS from 14 centers were enrolled. Children with active NS defined as the presence of nephrotic range proteinuria (>2+ urinalysis and edema or urine protein/creatinine ratio >2 g/g) were eligible. Comparisons were made between children with prevalent (N=67) and incident (N=60) disease at the study enrollment visit. Results The PROMIS scores were worse in prevalent patients in the domains of peer relationship (p=0.01) and pain interference (p < 0.01). The PedsQL showed worse scores in prevalent patients for social functioning (p < 0.01) and school functioning (p = 0.03). Multivariable analyses showed that prevalent patients had worse scores in PROMIS pain interference (p=0.02) and PedsQL social functioning (p<0.01). Conclusion The PROMIS measures detected a significant impact of disease duration on HRQOL in children, such that peer relationships were worse and pain interfered with daily life to a greater degree among those with longer disease duration. These findings were in agreement with those for similar domains in the PedsQL legacy instrument. PMID:25784017

Modeling of Protection in Dynamic Simulation Using Generic Relay Models and Settings

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

Samaan, Nader A.; Dagle, Jeffery E.; Makarov, Yuri V.

This paper shows how generic protection relay models available in planning tools can be augmented with settings that are based on NERC standards or best engineering practice. Selected generic relay models in Siemens PSS®E have been used in dynamic simulations in the proposed approach. Undervoltage, overvoltage, underfrequency, and overfrequency relays have been modeled for each generating unit. Distance-relay protection was modeled for transmission system protection. Two types of load-shedding schemes were modeled: underfrequency (frequency-responsive non-firm load shedding) and underfrequency and undervoltage firm load shedding. Several case studies are given to show the impact of protection devices on dynamic simulations. Thismore » is useful for simulating cascading outages.« less

Rubber-Modified Epoxy and Glass Laminates for Application to Naval Ship Structures.

DTIC Science & Technology

1983-09-01

more information. Two generic carboxy terminated butadiene acrylonitrile ( CTBN )-modified epoxy/glass cloth material systems have been characterized...versus Normal Impact Energy of 7781-Z6040/Fl55 .......... .................... 8 4 - Front Surface of CTBN -Modified Epoxy GRP Panel After 60 Impacts at...15 6 - Back Surface of CTBN -Modified Epoxy GRP Panel After 60 Impacts at 206 Foot-Pounds ..... .................. ... 16 7 - Back Surface of

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

The short-term impact of Ontario's generic pricing reforms.

PubMed

Law, Michael R; Ystma, Alison; Morgan, Steven G

2011-01-01

Canadians pay amongst the highest generic drug prices in the world. In July 2010, the province of Ontario enacted a policy that halved reimbursement for generic drugs from the public drug plan, and substantially lowered prices for private purchases. We quantified the impact of this policy on overall generic drug expenditures in the province, and projected the impact in other provinces had they mimicked this pricing change. We used quarterly prescription generic drug dispensing data from the IMS-Brogan CompuScript Audit. We used the price per unit in both the pre- and post-policy period and two economics price indexes to estimate the expenditure reduction in Ontario. Further, we used the post-policy Ontario prices to estimate the potential reduction in other provinces. We estimate that total expenditure on generic drugs in Ontario during the second half of 2010 was between $181 and $194 million below what would be expected if prices had remained at pre-policy level. Over half of the reduction in spending was due to savings on just 10 generic ingredients. If other provinces had matched Ontario's prices, their expenditures over during the latter half of 2010 would have been $445 million lower. We found that if Ontario's pricing scheme were adopted nationally, overall spending on generic drugs in Canada would drop at least $1.28 billion annually--a 5% decrease in total prescription drug expenditure. Other provinces should seriously consider both changes to their generic drug prices and the use of more competitive bulk purchasing policies.

Health-related quality of life impact in a randomised phase III study of the combination of dabrafenib and trametinib versus dabrafenib monotherapy in patients with BRAF V600 metastatic melanoma.

PubMed

Schadendorf, Dirk; Amonkar, Mayur M; Stroyakovskiy, Daniil; Levchenko, Evgeny; Gogas, Helen; de Braud, Filippo; Grob, Jean-Jacques; Bondarenko, Igor; Garbe, Claus; Lebbe, Celeste; Larkin, James; Chiarion-Sileni, Vanna; Millward, Michael; Arance, Ana; Mandalà, Mario; Flaherty, Keith T; Nathan, Paul; Ribas, Antoni; Robert, Caroline; Casey, Michelle; DeMarini, Douglas J; Irani, Jhangir G; Aktan, Gursel; Long, Georgina V

2015-05-01

To present the impact of treatments on health-related quality of life (HRQoL) from the double-blind, randomised phase III COMBI-d study that investigated the combination of dabrafenib and trametinib versus dabrafenib monotherapy in patients with BRAF V600E/K-mutant metastatic melanoma. COMBI-d showed significantly prolonged progression-free survival for the combination. HRQoL was evaluated using the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-C30, a generic cancer questionnaire (completed at baseline, during study treatment, at progression and post progression) assessing various dimensions (global health/QoL, functional status, and symptom impact). A mixed-model, repeated-measures analyses of covariance evaluated differences between arms. Questionnaire completion rates were >95% at baseline, >85% to week 40 and >70% at disease progression. Baseline scores across both arms were comparable for all dimensions. Global health dimension scores were significantly better at weeks 8, 16 and 24 for patients receiving the combination during treatment and at progression. The majority of functional dimension scores (physical, social, role, emotional and cognitive functioning) trended in favour of the combination. Pain scores were significantly improved and clinically meaningful (6-13 point difference) for patients receiving the combination for all follow-up assessments versus those receiving dabrafenib monotherapy. For other symptom dimensions (nausea and vomiting, diarrhoea, dyspnoea, and constipation), scores trended in favour of dabrafenib monotherapy. This analysis demonstrates that the combination of dabrafenib and trametinib provides better preservation of HRQoL and pain improvements versus dabrafenib monotherapy while also delaying progression. (Clinicaltrials.gov registration number: NCT01584648). Copyright © 2015 Elsevier Ltd. All rights reserved.

Generic, Type-Safe and Object Oriented Computer Algebra Software

NASA Astrophysics Data System (ADS)

Kredel, Heinz; Jolly, Raphael

Advances in computer science, in particular object oriented programming, and software engineering have had little practical impact on computer algebra systems in the last 30 years. The software design of existing systems is still dominated by ad-hoc memory management, weakly typed algorithm libraries and proprietary domain specific interactive expression interpreters. We discuss a modular approach to computer algebra software: usage of state-of-the-art memory management and run-time systems (e.g. JVM) usage of strongly typed, generic, object oriented programming languages (e.g. Java) and usage of general purpose, dynamic interactive expression interpreters (e.g. Python) To illustrate the workability of this approach, we have implemented and studied computer algebra systems in Java and Scala. In this paper we report on the current state of this work by presenting new examples.

Hand-assisted laparoscopic sigmoid colectomy skills acquisition: augmented reality simulator versus human cadaver training models.

PubMed

Leblanc, Fabien; Senagore, Anthony J; Ellis, Clyde N; Champagne, Bradley J; Augestad, Knut M; Neary, Paul C; Delaney, Conor P

2010-01-01

The aim of this study was to compare a simulator with the human cadaver model for hand-assisted laparoscopic colorectal skills acquisition training. An observational prospective comparative study was conducted to compare the laparoscopic surgery training models. The study took place during the laparoscopic colectomy training course performed at the annual scientific meeting of the American Society of Colon and Rectal Surgeons. Thirty four practicing surgeons performed hand-assisted laparoscopic sigmoid colectomy on human cadavers (n = 7) and on an augmented reality simulator (n = 27). Prior laparoscopic colorectal experience was assessed. Trainers and trainees completed independently objective structured assessment forms. Training models were compared by trainees' technical skills scores, events scores, and satisfaction. Prior laparoscopic experience was similar in both surgeon groups. Generic and specific skills scores were similar on both training models. Generic events scores were significantly better on the cadaver model. The 2 most frequent generic events occurring on the simulator were poor hand-eye coordination and inefficient use of retraction. Specific events were scored better on the simulator and reached the significance limit (p = 0.051) for trainers. The specific events occurring on the cadaver were intestinal perforation and left ureter identification difficulties. Overall satisfaction was better for the cadaver than for the simulator model (p = 0.009). With regard to skills scores, the augmented reality simulator had adequate qualities for the hand-assisted laparoscopic colectomy training. Nevertheless, events scores highlighted weaknesses of the anatomical replication on the simulator. Although improvements likely will be required to incorporate the simulator more routinely into the colorectal training, it may be useful in its current form for more junior trainees or those early on their learning curve. Copyright 2010 Association of Program Directors in Surgery. Published by Elsevier Inc. All rights reserved.

The impact of generic substitution on the turnover and gross margin of pharmaceutical companies a survey 1 year and 5 years after the introduction of generic substitution in Finland.

PubMed

Timonen, Johanna; Karttunen, Pekka; Bengtström, Marina; Ahonen, Riitta

2009-10-01

To explore and compare the impact of generic substitution (GS) on the turnover and gross margin per cent of pharmaceutical companies representing mainly original or generic products in Finland. A mail survey to pharmaceutical companies with an office in Finland and substitutable medicines in the Finnish pharmaceutical market 1 year (2004) and nearly 5 years (2008) after GS. The questionnaire were answered by 16 original and 7 generic product companies in 2004 (response rate 56%, n=41) and by 16 original and 6 generic product companies in 2008 (response rate 56%, n=39). Turnover had decreased in the original product companies and increased in the generic product companies. The gross margin per cent had decreased in the original and generic product companies, and the companies had also compensated for it in many ways. The study suggests that GS has promoted the sales of generic product companies in Finland. However, price competition caused by GS has generally decreased the proportion of profit from turnover in the original and generic product companies. The companies have also compensated for their decreased gross margin, which suggests that the profit in euros has not been sufficient to cover fixed costs in the companies.

The PedsQL in pediatric cancer: reliability and validity of the Pediatric Quality of Life Inventory Generic Core Scales, Multidimensional Fatigue Scale, and Cancer Module.

PubMed

Varni, James W; Burwinkle, Tasha M; Katz, Ernest R; Meeske, Kathy; Dickinson, Paige

2002-04-01

The Pediatric Quality of Life Inventory (PedsQL) is a modular instrument designed to measure health-related quality of life (HRQOL) in children and adolescents ages 2-18 years. The PedsQL 4.0 Generic Core Scales are multidimensional child self-report and parent proxy-report scales developed as the generic core measure to be integrated with the PedsQL disease specific modules. The PedsQL Multidimensional Fatigue Scale was designed to measure fatigue in pediatric patients. The PedsQL 3.0 Cancer Module was designed to measure pediatric cancer specific HRQOL. The PedsQL Generic Core Scales, Multidimensional Fatigue Scale, and Cancer Module were administered to 339 families (220 child self-reports; 337 parent proxy-reports). Internal consistency reliability for the PedsQL Generic Core Total Scale Score (alpha = 0.88 child, 0.93 parent report), Multidimensional Fatigue Total Scale Score (alpha = 0.89 child, 0.92 parent report) and most Cancer Module Scales (average alpha = 0.72 child, 0.87 parent report) demonstrated reliability acceptable for group comparisons. Validity was demonstrated using the known-groups method. The PedsQL distinguished between healthy children and children with cancer as a group, and among children on-treatment versus off-treatment. The validity of the PedsQL Multidimensional Fatigue Scale was further demonstrated through hypothesized intercorrelations with dimensions of generic and cancer specific HRQOL. The results demonstrate the reliability and validity of the PedsQL Generic Core Scales, Multidimensional Fatigue Scale, and Cancer Module in pediatric cancer. The PedsQL may be utilized as an outcome measure in clinical trials, research, and clinical practice. Copyright 2002 American Cancer Society.

Comparing Tolerability and Efficacy of Generic versus Brand Alendronate: A Randomized Clinical Study in Postmenopausal Women with a Recent Fracture

PubMed Central

van den Bergh, Joop P. W.; Bouts, Marian E.; van der Veer, Eveline; van der Velde, Robert Y.; Janssen, Marcel J. W.; Geusens, Piet P.; Winkens, Bjorn; Oldenhof, Nico J. J.; van Geel, Tineke A. C. M.

2013-01-01

Introduction An increasing number of generic alendronate formulations have become available. Although expected to have the same tolerability and efficacy, head-to head comparison of generic and brand alendronate was never performed. Therefore, we compared the tolerability and efficacy of generic and brand alendronate. Methods In a randomized double-blinded single centre cross-over study in 37 postmenopausal women (mean age 65.4±6.4 years) with osteoporosis were treated with generic and branded alendronate during 24 (2x12) weeks. Tolerance was evaluated by the Gastro intestinal Symptom Rating Scale (GSRS) and self-reported side effects. Efficacy was assessed by serum bone turnover markers, carboxy terminal telopeptide (CTX) and procollagen type I N-terminal propeptide (PINP). No wash out period was allowed (ethical reasons). Because of possible carry over effect only data of the first 12 weeks were analyzed using linear mixed models. Results There were no significant differences in overall tolerance (GSRS) between treatment groups. However, for subscale abdominal pain, patients using generic had a significantly higher mean GSRS score at week 4 (estimated mean difference (B): 0.40; 95%CI: 0.05 to 0.74, p = 0.024). The level of bone turnover markers significantly decreased over 12 weeks of follow-up for generic and branded alendronate (p < 0.001). Mean level of CTX was significantly lower with branded at week 4 (B: 121.3; 95%CI: 52.0 to 190.5), but not at week 12 (B: 53.6; 95%CI:-3.7 to 110.9). No significant differences were found for PINP at week 4 or 12. Conclusions Bone turnover markers were significantly reduced with branded and generic alendronate. With branded, CTX was significantly lower at 4 weeks. Generic caused significantly higher abdominal pain scores in the first 4 weeks of treatment. Therefore, generic alendronate may not have the same tolerability and efficacy as branded alendronate in the first weeks after starting treatment in patients with a recent fracture. Trial Registration Dutch Trial Register NTR number 1867 http://www.trialregister.nl/trialreg/admin/rctview.asp?TC=1867 PMID:24205135

Health-related quality of life in patients with atopic dermatitis.

PubMed

Maksimović, Nataša; Janković, Slavenka; Marinković, Jelena; Sekulović, Lidija K; Zivković, Zorica; Spirić, Vesna T

2012-01-01

Atopic dermatitis (AD) is a chronic relapsing condition that can have considerable effects on the patients' quality of life (QOL). The aim of this study was to measure the health-related QOL in patients with AD, using generic and specific instruments, to compare the scores obtained by different instruments and to verify the relationship between them. We conducted a cross-sectional study of 132 outpatients with AD. To assess the QOL, Short Form 36 (SF-36), Dermatology Life Quality Index (DLQI) and Children's Dermatology Life Quality Index (CDLQI) were administered. In order to assess the disease severity of AD, we used the Eczema Area and Severity Index (EASI) and physician assessment of disease severity. Stressful life events during the last 12 months were assessed with Paykel's Interview for Recent Life Events. Patients with AD had inferior social functioning and mental health scores compared with the general population. The correlations between the DLQI and SF-36 were found for the mental components of the QOL. Increasing disease severity was associated with greater impairment in QOL in both, children and adults. Our study found the influence of the stressful life events on the role emotional of AD patients. These results demonstrate that AD influences health-related QOL, especially in children. This study supports the decision to use both generic and skin-specific instruments to assess the impact of AD on QOL. © 2011 Japanese Dermatological Association.

The Short-Term Impact of Ontario's Generic Pricing Reforms

PubMed Central

Law, Michael R.; Ystma, Alison; Morgan, Steven G.

2011-01-01

Background Canadians pay amongst the highest generic drug prices in the world. In July 2010, the province of Ontario enacted a policy that halved reimbursement for generic drugs from the public drug plan, and substantially lowered prices for private purchases. We quantified the impact of this policy on overall generic drug expenditures in the province, and projected the impact in other provinces had they mimicked this pricing change. Methods We used quarterly prescription generic drug dispensing data from the IMS-Brogan CompuScript Audit. We used the price per unit in both the pre- and post-policy period and two economics price indexes to estimate the expenditure reduction in Ontario. Further, we used the post-policy Ontario prices to estimate the potential reduction in other provinces. Results We estimate that total expenditure on generic drugs in Ontario during the second half of 2010 was between $181 and $194 million below what would be expected if prices had remained at pre-policy level. Over half of the reduction in spending was due to savings on just 10 generic ingredients. If other provinces had matched Ontario's prices, their expenditures over during the latter half of 2010 would have been $445 million lower. Discussion We found that if Ontario's pricing scheme were adopted nationally, overall spending on generic drugs in Canada would drop at least $1.28 billion annually—a 5% decrease in total prescription drug expenditure. Other provinces should seriously consider both changes to their generic drug prices and the use of more competitive bulk purchasing policies. PMID:21829581

Pain, Fatigue, and Psychological Impact on Health-Related Quality of Life in Childhood-Onset Lupus.

PubMed

Jones, Jordan T; Cunningham, Natoshia; Kashikar-Zuck, SusmitA; Brunner, Hermine I

2016-01-01

To evaluate pain, fatigue, and psychological functioning of childhood-onset systemic lupus erythematosus (SLE) patients and examine how these factors impact health-related quality of life (HRQOL). At a tertiary rheumatology clinic, 60 childhood-onset SLE patients completed the following: a visual analog scale (VAS) of pain intensity (0-10), the Pediatric Quality of Life (PedsQL) multidimensional fatigue scale, Pain Coping Questionnaire, Pain Catastrophizing Scale (PCS), Children's Depression Inventory I (CDI-I), the Screen for Child Anxiety Related Emotional Disorders (SCARED) questionnaire, and the PedsQL generic core (GC) scale and rheumatology module (RM). Sociodemographics and multiple disease activity indicators were recorded. Fatigue was present in 65% of the patients. Clinically relevant pain (pain-VAS >3), anxiety (SCARED ≥25), and depressive symptoms (CDI-I >12) were observed in 40%, 37%, and 30% of the patients, respectively; 22% had high catastrophizing (PCS ≥26). On average, the PedsQL-GC and -RM scores for childhood-onset SLE were lower than in healthy norms. Reduced PedsQL-GC and -RM scores were highly correlated with greater levels of fatigue, anxiety, and depressive symptoms (Pearson's r > 0.65), but had weak correlation with disease activity (Pearson's r < 0.25). Regression analysis demonstrated HRQOL was most impacted by fatigue, pain, and anxiety when evaluating all factors concurrently (P < 0.001). Childhood-onset SLE is associated with decreased HRQOL, and psychological aspects of health contribute substantially to low HRQOL, whereas measures of childhood-onset SLE activity seem less relevant. Fatigue, pain, mood, and anxiety symptoms are present in a large subgroup of patients and need medical attention to achieve optimal health outcomes. © 2016, American College of Rheumatology.

The impact of generic substitution on the activities of pharmaceutical companies - a survey from the companies' perspective one year and five years after the introduction of generic substitution in finland

PubMed Central

2010-01-01

Background Mandatory generic substitution (GS) was introduced in Finland on 1 April 2003. The aim of this study was to explore and compare the impacts of GS on the activities of pharmaceutical companies representing mainly original or generic pharmaceutical products in Finland. The self-reported impact of GS from pharmaceutical companies' perspective was explored with a focus on the number of employees, the range of sales packages on the market, the marketing activities, the research and development of new pharmaceutical products and storage of pharmaceuticals. Methods A cross-sectional postal survey was conducted among pharmaceutical companies with an office in Finland and substitutable medicines in the Finnish pharmaceutical market one year (2004) and five years (2008) after the introduction of GS. Completed questionnaires were returned by 16 original and 7 generic product companies in 2004 (response rate 56%, n = 41) and by 16 original and 6 generic product companies in 2008 (response rate 56%, n = 39). Descriptive statistical analyses were performed. Results The number of employees (2004: n = 6/16, 2008: n = 7/16) and the amount of prescription medicine marketing (2004: n = 7/16, 2008: n = 8/16) decreased in many of the original product companies after the introduction of GS. GS resulted in problems related to the storage of pharmaceuticals in the original product companies shortly after GS was introduced (p = 0.032 between 2004 and 2008). In the generic product companies, the prescription medicine representatives' visits to pharmacies increased at the beginning of GS (p = 0.021 between 2004 and 2008). In addition, GS caused problems with the storage of pharmaceuticals one year and five years after the reform (2004: n = 4/7, 2008: n = 3/6). The differences between original and generic product companies regarding the impacts of GS were not, however, statistically significant. GS did not affect on the range of sales packages on the market or the research activities of the majority of companies. Conclusions The study suggests that GS has had impacts on the activities of pharmaceutical companies in Finland. There were also some differences, although not statistically significant, between the surveyed original and generic product companies regarding the self-reported impacts of GS. More investigations are needed in this field. PMID:20964869

The impact of generic substitution on the activities of pharmaceutical companies - a survey from the companies' perspective one year and five years after the introduction of generic substitution in finland.

PubMed

Timonen, Johanna; Bengtström, Marina; Karttunen, Pekka; Ahonen, Riitta

2010-10-22

Mandatory generic substitution (GS) was introduced in Finland on 1 April 2003. The aim of this study was to explore and compare the impacts of GS on the activities of pharmaceutical companies representing mainly original or generic pharmaceutical products in Finland. The self-reported impact of GS from pharmaceutical companies' perspective was explored with a focus on the number of employees, the range of sales packages on the market, the marketing activities, the research and development of new pharmaceutical products and storage of pharmaceuticals. A cross-sectional postal survey was conducted among pharmaceutical companies with an office in Finland and substitutable medicines in the Finnish pharmaceutical market one year (2004) and five years (2008) after the introduction of GS. Completed questionnaires were returned by 16 original and 7 generic product companies in 2004 (response rate 56%, n = 41) and by 16 original and 6 generic product companies in 2008 (response rate 56%, n = 39). Descriptive statistical analyses were performed. The number of employees (2004: n = 6/16, 2008: n = 7/16) and the amount of prescription medicine marketing (2004: n = 7/16, 2008: n = 8/16) decreased in many of the original product companies after the introduction of GS. GS resulted in problems related to the storage of pharmaceuticals in the original product companies shortly after GS was introduced (p = 0.032 between 2004 and 2008). In the generic product companies, the prescription medicine representatives' visits to pharmacies increased at the beginning of GS (p = 0.021 between 2004 and 2008). In addition, GS caused problems with the storage of pharmaceuticals one year and five years after the reform (2004: n = 4/7, 2008: n = 3/6). The differences between original and generic product companies regarding the impacts of GS were not, however, statistically significant. GS did not affect on the range of sales packages on the market or the research activities of the majority of companies. The study suggests that GS has had impacts on the activities of pharmaceutical companies in Finland. There were also some differences, although not statistically significant, between the surveyed original and generic product companies regarding the self-reported impacts of GS. More investigations are needed in this field.

A Milestone-Based Evaluation System-The Cure for Grade Inflation?

PubMed

Kuo, Lindsay E; Hoffman, Rebecca L; Morris, Jon B; Williams, Noel N; Malachesky, Mark; Huth, Laura E; Kelz, Rachel R

2015-01-01

Controversy exists over the optimal use of the Milestones in the process of resident evaluation and feedback. We sought to evaluate the performance of a Milestones-based feedback system in comparison to a traditional model. The traditional evaluation system (TES) consisted of a generic 16-item survey using a 5-point Likert scale ranging from 1 to 5, and a free-text comments section. The Milestones-based evaluation system (MBES) was launched in July 2014, ranging from 0 to 4. Individual milestones were mapped to rotations based on resident educational goals by postgraduate year (PGY). The MBES consisted of a survey with a maximum of 7 items, followed by a free-text comment section. Within each evaluation system, an overall composite score was calculated for each categorical general surgical resident. To scale the 2 systems for comparison, TES scores were adjusted downward by 1 point. Descriptive statistics were performed. Univariate analysis was performed with the Wilcoxon signed-rank test. A test for trend across PGY was used for the MBES only. In the traditional system, the median score was 3.66 (range: 3.2-4.0). There was no meaningful difference in the median score by PGY. In the new system, the median score was 2.69 (range: 1.5-3.7, p < 0.01). The median score differed across PGY and increased by PGY of training (p < 0.01). There was an increase in differences between median scores by PGY. On using the milestones to facilitate faculty evaluation of resident knowledge and skill, there was a trend in increasing score by PGY of training. In the MBES, scores could be used to better discriminate resident skill and knowledge levels and resulted in improved differentiation in scoring by PGY. The use of the milestones as a basis for evaluation enabled the program to provide more meaningful feedback to residents and represents an improvement in surgical education. Copyright © 2015 Association of Program Directors in Surgery. Published by Elsevier Inc. All rights reserved.

Environmental assessment of the 40 kilowatt fuel cell system field test operation

NASA Technical Reports Server (NTRS)

Bollenbacher, G.

1982-01-01

This environmental assessment examines the potential environmental consequences, both adverse and beneficial, of the 40 kW fuel cell system system field test operation. The assessment is of necessity generic in nature since actual test sites were not selected. This assessment provides the basis for determining the need for an environmental impact statement. In addition, this assessment provides siting criteria to avoid or minimize negative environmental impacts and standards for determining candidate test sites, if any, for which site specific assessments may be required.

Responsiveness of the EQ-5D to HADS-identified anxiety and depression.

PubMed

Whynes, David K

2009-10-01

The use of generic measures of health-related quality of life enables cost effectiveness comparisons of different health care interventions to be made. Nevertheless, there exists a concern that generic instruments may be insufficiently sensitive to detect the differences or changes in outcome identified by condition-specific instruments. This paper compares the psychometric properties of the EQ-5D generic instrument with a widely used specific measure of distress, the Hospital Anxiety and Depression Scale (HADS). The analysis was based on data obtained from a large sample of women (n = 3119) with low-grade cervical cytological abnormalities detected at routine screening. These women completed EQ-5D and HADS questionnaires at recruitment and at 12 months thereafter. We examined the strength of association between HADS-determined severity of distress and EQ-5D scores at recruitment and between changes in severity and in scores over time. A higher likelihood of HADS-identified anxiety and/or depression was associated with significantly lower EQ-5D index and visual analogue scores. Over time, the EQ-5D score rose significantly when the likelihood of an individual representing a HADS-defined anxiety and/or depression case decreased. We conclude that the EQ-5D has shown itself to be responsive to differing degrees of HADS-assessed distress, although generalization beyond the UK context requires further investigation.

Psychometric characteristics of the chronic Otitis media questionnaire 12 (COMQ - 12): stability of factor structure and replicability shown by the Serbian version.

PubMed

Bukurov, Bojana; Arsovic, Nenad; Grujicic, Sandra Sipetic; Haggard, Mark; Spencer, Helen; Marinkovic, Jelena Eric

2017-10-23

Recently, demand for and supply of short-form patient-reported outcome measures (PROMs) have risen throughout the world healthcare. Our contribution to meeting that demand has been translating and culturally adapting the Chronic Otitis Media Questionnaire-12 (COMQ-12) for adults into Serbian and enhancing its psychometric base on the relatively large Serbian COM caseload. Chronic otitis media can seriously affect quality of life progressively and in long-term, and it remains the major source of hearing problems in the developing world. The translated questionnaire was given twice to 60 adult patients with chronic otitis media of three types (inactive, active mucosal and active squamous disease) and to 60 healthy volunteers. Both patients and volunteers also filled the generic Short-Form 36 questionnaire (SF-36). Conventional statistical procedures were used in strategically driven development of scoring. Additionally, item responses were scaled by linear mapping against the provisional total score. Generalizability, detailed factor interpretation and supportability of scores were criteria, for the best compromise factor solution. Test-retest reliability was very high (0.924 to 0.989, depending on score). The a priori content dimensions of the questionnaire were strongly supported by 3-factor exploratory and confirmatory factor analyses for content validity, separating (i) ear symptoms from (ii) hearing problems, from (iii) daily activity restriction plus healthcare uptake. The 3-factor structure was furthermore highly stable on replication. The very large effect sizes when contrasting patients with healthy volunteers, and active with inactive disease established construct validity for the total score. A strong association with disease activity and a moderate one with generic health-related quality of life (HRQoL), the SF-36, supported construct validity for two of three factors extracted (ear symptoms, and impact on daily activities plus healthcare uptake). Given the minimal psychometric work to date on COMQ-12, this interim sample with 120 data points adds materially to knowledge of its reliability, several forms of validity and the feasibility of profile sub-scores to supplement total scores. The good psychometric properties shown for COMQ-12 justify both its routine clinical use and acquisition of the necessarily larger sample for generality, score optimisation and the evaluation of responsiveness.

The impact of price-cap regulations on market entry by generic pharmaceutical firms.

PubMed

Zhang, Wei; Sun, Huiying; Guh, Daphne; Anis, Aslam H

2017-04-01

In 1998, the province of Ontario, Canada implemented price-cap '70/90' regulations: the first generic must be priced at ≤70% of the associated brand-name price and subsequent generics must be priced at ≤90% of the first generics' price. The price-cap was further lowered to 50% in 2006 and 25% in 2010 for all generic drugs regardless of the first or subsequent generic entrants. This study assessed the impact of such price-cap regulations on market entry by generic firms using the formulary database from 9 provinces (January 2004-March 2013). A logistic regression was estimated to compare the probability of entry during the three policy periods in Ontario ('70/90', '25', versus '50'). Since different price-caps were subsequently introduced in other provinces, Alberta, British Columbia, New Brunswick and Saskatchewan, difference-in-differences was used to compare market entry. In Ontario, compared with the period '50', generic firms were 76% and 63% less likely to enter markets in the periods '25' and '70/90', respectively. The difference-in-differences showed that the entry probability decreased the most in Ontario during the '25' period from the '50' period. Lowering the price-cap level to 25% leads to a significantly lower probability of market entry by generic firms.

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.

Primary propulsion/large space system interactions

NASA Technical Reports Server (NTRS)

Dergance, R. H.

1980-01-01

Three generic types of structural concepts and nonstructural surface densities were selected and combined to represent potential LSS applications. The design characteristics of various classes of large space systems that are impacted by primary propulsion thrust required to effect orbit transfer were identified. The effects of propulsion system thrust-to-mass ratio, thrust transients, and performance on the mass, area, and orbit transfer characteristics of large space systems were determined.

From LCAs to simplified models: a generic methodology applied to wind power electricity.

PubMed

Padey, Pierryves; Girard, Robin; le Boulch, Denis; Blanc, Isabelle

2013-02-05

This study presents a generic methodology to produce simplified models able to provide a comprehensive life cycle impact assessment of energy pathways. The methodology relies on the application of global sensitivity analysis to identify key parameters explaining the impact variability of systems over their life cycle. Simplified models are built upon the identification of such key parameters. The methodology is applied to one energy pathway: onshore wind turbines of medium size considering a large sample of possible configurations representative of European conditions. Among several technological, geographical, and methodological parameters, we identified the turbine load factor and the wind turbine lifetime as the most influent parameters. Greenhouse Gas (GHG) performances have been plotted as a function of these key parameters identified. Using these curves, GHG performances of a specific wind turbine can be estimated, thus avoiding the undertaking of an extensive Life Cycle Assessment (LCA). This methodology should be useful for decisions makers, providing them a robust but simple support tool for assessing the environmental performance of energy systems.

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.

Hepatitis C virus adversely affects quality of life.

PubMed

Cillo, Umberto; Amodio, Piero; Ronco, Claudio; Soni, Sachin S; Zanus, Giacomo; Minazzato, Lina; Salari, Annalisa; Neri, Daniele; Bombonato, Giancarlo; Schiff, Sami; Bianco, Tonino

2011-01-01

Chronic liver disease secondary to hepatitis C virus (HCV) infection is a common clinical problem. HCV is likely to adversely affect the quality of life (QoL) of the patient. This effect is said to be disproportionate to the severity of the disease. The aim of our study was to evaluate QoL in HCV-positive patients focusing both on health status and subjective satisfaction. Twenty-four patients with combined HCV and alcoholic liver disease (ETOH-HCV) were enrolled in the study. We adopted two generic tools: SF-36 (a health status questionnaire) and SAT-P (a satisfaction profile) for psychological assessment of the patients. SF-36 and SAT-P scores of ETOH-HCV patients were compared with scores of 23 patients with alcoholic liver disease (ETOH). The scores obtained from the study groups were also compared with the reference scores of the healthy Italian population. Both the groups were comparable with respect to age, histological and clinical severity of liver disease (as assessed by MELD and Child Pugh scores). Patients with ETOH-HCV scored less in the vitality and role emotional status domains of the SF-36 scores and the psychological function, social function and free time domains of the satisfaction profile. These results show a significant impact of HCV infection on health status and subjective satisfaction. Copyright © 2011 S. Karger AG, Basel.

Development of an Evaluation Methodology for Triple Bottom Line Reports Using International Standards on Reporting

NASA Astrophysics Data System (ADS)

Skouloudis, Antonis; Evangelinos, Konstantinos; Kourmousis, Fotis

2009-08-01

The purpose of this article is twofold. First, evaluation scoring systems for triple bottom line (TBL) reports to date are examined and potential methodological weaknesses and problems are highlighted. In this context, a new assessment methodology is presented based explicitly on the most widely acknowledged standard on non-financial reporting worldwide, the Global Reporting Initiative (GRI) guidelines. The set of GRI topics and performance indicators was converted into scoring criteria while the generic scoring devise was set from 0 to 4 points. Secondly, the proposed benchmark tool was applied to the TBL reports published by Greek companies. Results reveal major gaps in reporting practices, stressing the need for the further development of internal systems and processes in order to collect essential non-financial performance data. A critical overview of the structure and rationale of the evaluation tool in conjunction with the Greek case study is discussed while recommendations for future research on the field of this relatively new form of reporting are suggested.

Development of an evaluation methodology for triple bottom line reports using international standards on reporting.

PubMed

Skouloudis, Antonis; Evangelinos, Konstantinos; Kourmousis, Fotis

2009-08-01

The purpose of this article is twofold. First, evaluation scoring systems for triple bottom line (TBL) reports to date are examined and potential methodological weaknesses and problems are highlighted. In this context, a new assessment methodology is presented based explicitly on the most widely acknowledged standard on non-financial reporting worldwide, the Global Reporting Initiative (GRI) guidelines. The set of GRI topics and performance indicators was converted into scoring criteria while the generic scoring devise was set from 0 to 4 points. Secondly, the proposed benchmark tool was applied to the TBL reports published by Greek companies. Results reveal major gaps in reporting practices, stressing the need for the further development of internal systems and processes in order to collect essential non-financial performance data. A critical overview of the structure and rationale of the evaluation tool in conjunction with the Greek case study is discussed while recommendations for future research on the field of this relatively new form of reporting are suggested.

Evaluation of "e-rater"® for the "Praxis I"®Writing Test. Research Report. ETS RR-15-03

ERIC Educational Resources Information Center

Ramineni, Chaitanya; Trapani, Catherine S.; Williamson, David M.

2015-01-01

Automated scoring models were trained and evaluated for the essay task in the "Praxis I"® writing test. Prompt-specific and generic "e-rater"® scoring models were built, and evaluation statistics, such as quadratic weighted kappa, Pearson correlation, and standardized differences in mean scores, were examined to evaluate the…

The dark side of gendered language: The masculine-generic form as a cause for self-report bias.

PubMed

Vainapel, Sigal; Shamir, Opher Y; Tenenbaum, Yulie; Gilam, Gadi

2015-12-01

Language reflects sociocultural structures, such as gender, and affects individuals' perceptions and cognitions. In gendered languages, male-inflected parts of speech are generally used for both sexes (i.e., masculine generics), thus proliferating stereotypes, inequality, and misattributions. We hypothesized that masculine-generic inflection in a questionnaire would bias women's reports compared with a gender-neutral inflection (e.g., "he or she"). We tested our prediction using an academic motivation questionnaire. We found that women reported lower task value and intrinsic goal orientation in the masculine-generic form compared with the gender-neutral form, and lower self-efficacy than men in the masculine-generic form. These findings suggest that questionnaires and surveys written in gendered languages or translated into them may contain construct-irrelevant variance that may undermine the validity of their scores' interpretations, thus risking the possibility of false conclusions. (c) 2015 APA, all rights reserved).

Impact of generic substitution decision support on electronic prescribing behavior.

PubMed

Stenner, Shane P; Chen, Qingxia; Johnson, Kevin B

2010-01-01

To evaluate the impact of generic substitution decision support on electronic (e-) prescribing of generic medications. The authors analyzed retrospective outpatient e-prescribing data from an academic medical center and affiliated network for July 1, 2005-September 30, 2008 using an interrupted time-series design to assess the rate of generic prescribing before and after implementing generic substitution decision support. To assess background secular trends, e-prescribing was compared with a concurrent random sample of hand-generated prescriptions. Proportion of generic medications prescribed before and after the intervention, evaluated over time, and compared with a sample of prescriptions generated without e-prescribing. The proportion of generic medication prescriptions increased from 32.1% to 54.2% after the intervention (22.1% increase, 95% CI 21.9% to 22.3%), with no diminution in magnitude of improvement post-intervention. In the concurrent control group, increases in proportion of generic prescriptions (29.3% to 31.4% to 37.4% in the pre-intervention, post-intervention, and end-of-study periods, respectively) were not commensurate with the intervention. There was a larger change in generic prescribing rates among authorized prescribers (24.6%) than nurses (18.5%; adjusted OR 1.38, 95% CI 1.17 to 1.63). Two years after the intervention, the proportion of generic prescribing remained significantly higher for e-prescriptions (58.1%; 95% CI 57.5% to 58.7%) than for hand-generated prescriptions ordered at the same time (37.4%; 95% CI 34.9% to 39.9%) (p<0.0001). Generic prescribing increased significantly in every specialty. Implementation of generic substitution decision support was associated with dramatic and sustained improvements in the rate of outpatient generic e-prescribing across all specialties.

Impact of generic substitution decision support on electronic prescribing behavior

PubMed Central

Chen, Qingxia; Johnson, Kevin B

2010-01-01

Objective To evaluate the impact of generic substitution decision support on electronic (e-) prescribing of generic medications. Design The authors analyzed retrospective outpatient e-prescribing data from an academic medical center and affiliated network for July 1, 2005–September 30, 2008 using an interrupted time-series design to assess the rate of generic prescribing before and after implementing generic substitution decision support. To assess background secular trends, e-prescribing was compared with a concurrent random sample of hand-generated prescriptions. Measurements Proportion of generic medications prescribed before and after the intervention, evaluated over time, and compared with a sample of prescriptions generated without e-prescribing. Results The proportion of generic medication prescriptions increased from 32.1% to 54.2% after the intervention (22.1% increase, 95% CI 21.9% to 22.3%), with no diminution in magnitude of improvement post-intervention. In the concurrent control group, increases in proportion of generic prescriptions (29.3% to 31.4% to 37.4% in the pre-intervention, post-intervention, and end-of-study periods, respectively) were not commensurate with the intervention. There was a larger change in generic prescribing rates among authorized prescribers (24.6%) than nurses (18.5%; adjusted OR 1.38, 95% CI 1.17 to 1.63). Two years after the intervention, the proportion of generic prescribing remained significantly higher for e-prescriptions (58.1%; 95% CI 57.5% to 58.7%) than for hand-generated prescriptions ordered at the same time (37.4%; 95% CI 34.9% to 39.9%) (p<0.0001). Generic prescribing increased significantly in every specialty. Conclusion Implementation of generic substitution decision support was associated with dramatic and sustained improvements in the rate of outpatient generic e-prescribing across all specialties. PMID:20962131

Reliability and construct validity of the Instrument to Measure the Impact of Valve Heart Disease on the Patient's Daily Life

PubMed Central

dos Anjos, Daniela Brianne Martins; Rodrigues, Roberta Cunha Matheus; Padilha, Kátia Melissa; Pedrosa, Rafaela Batista dos Santos; Gallani, Maria Cecília Bueno Jayme

2016-01-01

ABSTRACT Objective: evaluate the practicality, acceptability and the floor and ceiling effects, estimate the reliability and verify the convergent construct's validity with the instrument called the Heart Valve Disease Impact on daily life (IDCV) of the valve disease in patients with mitral and or aortic heart valve disease. Method: data was obtained from 86 heart valve disease patients through 3 phases: a face to face interview for a socio-demographic and clinic characterization and then other two done through phone calls of the interviewed patients for application of the instrument (test and repeat test). Results: as for the practicality and acceptability, the instrument was applied with an average time of 9,9 minutes and with 110% of responses, respectively. Ceiling and floor effects observed for all domains, especially floor effect. Reliability was tested using the test - repeating pattern to give evidence of temporal stability of the measurement. Significant negative correlations with moderate to strong magnitude were found between the score of the generic question about the impact of the disease and the scores of IDCV, which points to the validity of the instrument convergent construct. Conclusion: the instrument to measure the impact of valve heart disease on the patient's daily life showed evidence of reliability and validity when applied to patients with heart valve disease. PMID:27992024

The Impact of Generic Competencies on Workplace Performance. Review of Research.

ERIC Educational Resources Information Center

Moy, Janelle

The impact of generic competencies on workplace performance was examined through a review of literature and evaluation research which focused on conceptualization and piloting of the following key competencies in Australia in 1993-1998: collecting, analyzing, and organizing information; communicating ideas and information; planning and organizing…

78 FR 37325 - License Renewal of Nuclear Power Plants; Generic Environmental Impact Statement and Standard...

Federal Register 2010, 2011, 2012, 2013, 2014

2013-06-20

... Nuclear Power Plants; Generic Environmental Impact Statement and Standard Review Plans for Environmental... for Nuclear Power Plants, Supplement 1: Operating License Renewal'' (ESRP). The ESRP serves as a guide... published a final rule, ``Revisions to Environmental Review for Renewal of Nuclear Power Plant Operating...

78 FR 66858 - Waste Confidence-Continued Storage of Spent Nuclear Fuel

Federal Register 2010, 2011, 2012, 2013, 2014

2013-11-07

...-2012-0246] RIN 3150-AJ20 Waste Confidence--Continued Storage of Spent Nuclear Fuel AGENCY: Nuclear... its generic determination on the environmental impacts of the continued storage of spent nuclear fuel... revising the generic determination of the environmental impacts of the continued storage of spent nuclear...

Development of an integrated generic model for multi-scale assessment of the impacts of agro-ecosystems on major ecosystem services in West Africa.

PubMed

Belem, Mahamadou; Saqalli, Mehdi

2017-11-01

This paper presents an integrated model assessing the impacts of climate change, agro-ecosystem and demographic transition patterns on major ecosystem services in West-Africa along a partial overview of economic aspects (poverty reduction, food self-sufficiency and income generation). The model is based on an agent-based model associated with a soil model and multi-scale spatial model. The resulting Model for West-Africa Agro-Ecosystem Integrated Assessment (MOWASIA) is ecologically generic, meaning it is designed for all sudano-sahelian environments but may then be used as an experimentation facility for testing different scenarios combining ecological and socioeconomic dimensions. A case study in Burkina Faso is examined to assess the environmental and economic performances of semi-continuous and continuous farming systems. Results show that the semi-continuous system using organic fertilizer and fallowing practices contribute better to environment preservation and food security than the more economically performant continuous system. In addition, this study showed that farmers heterogeneity could play an important role in agricultural policies planning and assessment. In addition, the results showed that MOWASIA is an effective tool for designing, analysing the impacts of agro-ecosystems. Copyright © 2017. Published by Elsevier Ltd.

Taking the Sociological Imagination to School: An Analysis of the (Lack of) Impact of Information and Communication Technologies on Education Systems

ERIC Educational Resources Information Center

Somekh, Bridget

2004-01-01

This article suggests that it is time for sociologists to redirect their focus from critiques of policy makers' unrealistic visions for information and communication technologies (ICTs) to the more generic issues that consistently mobilise resistance to ICTs within schools and education systems. There is an extraordinary difference between young…

The shoulder pain and disability index: the construct validity and responsiveness of a region-specific disability measure.

PubMed

Heald, S L; Riddle, D L; Lamb, R L

1997-10-01

The purposes of this study were (1) to assess the construct validity of the Shoulder Pain and Disability Index (SPADI) and (2) to determine whether the SPADI is more responsive than the Sickness Impact Profile (SIP), a generic health status measure. The sample consisted of 94 patients who were diagnosed with a shoulder problem and referred to six outpatient physical therapy clinics. Clinically meaningful change was determined by use of an ordinal rating scale designed to determine whether the patient's shoulder function was improved, the same, or worse following treatment. Spearman rho correlations were calculated for the initial visit SPADI and SIP scores. The standardized response mean (SRM) was used to measure responsiveness for the patients who were judged to be improved. One-tailed paired t tests (alpha = .01) were used to determine whether differences existed among SRM values. Correlations between the SPADI and SIP scores ranged from r = .01 to r = .57. The SRM value was higher for the SPADI total score (SRM = 1.38) than for the SIP total score (SRM = 0.79). Most correlations between SPADI and SIP scores provided support for the construct validity of the SPADI. The SPADI does not appear to strongly reflect occupational and recreational disability and is more responsive than the SIP.

Does educational intervention improve doctors’ knowledge and perceptions of generic medicines and their generic prescribing rate? A study from Malaysia

PubMed Central

Wong, Zhi Yen; Alrasheedy, Alian A.; Saleem, Fahad; Mohamad Yahaya, Abdul Haniff; Aljadhey, Hisham

2014-01-01

Objectives: To investigate the impact of an educational intervention on doctors’ knowledge and perceptions towards generic medicines and their generic (international non-proprietary name) prescribing practice. Methods: This is a single-cohort pre-/post-intervention pilot study. The study was conducted in a tertiary care hospital in Perak, Malaysia. All doctors from the internal medicine department were invited to participate in the educational intervention. The intervention consisted of an interactive lecture, an educational booklet and a drug list. Doctors’ knowledge and perceptions were assessed by using a validated questionnaire, while the international non-proprietary name prescribing practice was assessed by screening the prescription before and after the intervention. Results: The intervention was effective in improving doctors’ knowledge towards bioequivalence, similarity of generic medicines and safety standards required for generic medicine registration (p = 0.034, p = 0.034 and p = 0.022, respectively). In terms of perceptions towards generic medicines, no significant changes were noted (p > 0.05). Similarly, no impact on international non-proprietary name prescribing practice was observed after the intervention (p > 0.05). Conclusion: Doctors had inadequate knowledge and misconceptions about generic medicines before the intervention. Moreover, international non-proprietary name prescribing was not a common practice. However, the educational intervention was only effective in improving doctors’ knowledge of generic medicines. PMID:26770747

The ability of cancer-specific and generic preference-based instruments to discriminate across clinical and self-reported measures of cancer severities

PubMed Central

2011-01-01

Objective To evaluate the validity of cancer-specific and generic preference-based instruments to discriminate across different measures of cancer severities. Methods Patients with breast (n = 66), colorectal (n = 57), and lung (n = 61) cancer completed the EORTC QLQ-C30 and the FACT-G, as well as three generic instruments: the EQ-5D, the SF-6D, and the HUI2/3. Disease severity was quantified using cancer stage, Eastern Cooperative Oncology Group Performance Status (ECOG-PS) score, and self-reported health status. Comparative analyses confirmed the multi-dimensional conceptualization of the instruments in terms of construct and convergent validity. Results In general, the instruments were able to discriminate across severity measures. The instruments demonstrated moderate to strong correlation with each other (r = 0.37-0.73). Not all of the measures could discriminate between different groups of disease severity: the EQ-5D and SF-6D were less discriminative than the HUI2/3 and the cancer-specific instruments. Conclusion The cancer-specific and generic preference-based instruments demonstrated to be valid in discriminating across levels of ECOG-PS scores and self-reported health states. However, the usefulness of the generic instruments may be limited if they are not able to detect small changes in health status within cancer patients. This raises concerns regarding the appropriateness of these instruments when comparing different cancer treatments within an economic evaluation framework. PMID:22123196

Generic Information Can Retrieve Known Biological Associations: Implications for Biomedical Knowledge Discovery

PubMed Central

van Haagen, Herman H. H. B. M.; 't Hoen, Peter A. C.; Mons, Barend; Schultes, Erik A.

2013-01-01

Motivation Weighted semantic networks built from text-mined literature can be used to retrieve known protein-protein or gene-disease associations, and have been shown to anticipate associations years before they are explicitly stated in the literature. Our text-mining system recognizes over 640,000 biomedical concepts: some are specific (i.e., names of genes or proteins) others generic (e.g., ‘Homo sapiens’). Generic concepts may play important roles in automated information retrieval, extraction, and inference but may also result in concept overload and confound retrieval and reasoning with low-relevance or even spurious links. Here, we attempted to optimize the retrieval performance for protein-protein interactions (PPI) by filtering generic concepts (node filtering) or links to generic concepts (edge filtering) from a weighted semantic network. First, we defined metrics based on network properties that quantify the specificity of concepts. Then using these metrics, we systematically filtered generic information from the network while monitoring retrieval performance of known protein-protein interactions. We also systematically filtered specific information from the network (inverse filtering), and assessed the retrieval performance of networks composed of generic information alone. Results Filtering generic or specific information induced a two-phase response in retrieval performance: initially the effects of filtering were minimal but beyond a critical threshold network performance suddenly drops. Contrary to expectations, networks composed exclusively of generic information demonstrated retrieval performance comparable to unfiltered networks that also contain specific concepts. Furthermore, an analysis using individual generic concepts demonstrated that they can effectively support the retrieval of known protein-protein interactions. For instance the concept “binding” is indicative for PPI retrieval and the concept “mutation abnormality” is indicative for gene-disease associations. Conclusion Generic concepts are important for information retrieval and cannot be removed from semantic networks without negative impact on retrieval performance. PMID:24260124

Potential of pedestrian protection systems--a parameter study using finite element models of pedestrian dummy and generic passenger vehicles.

PubMed

Fredriksson, Rikard; Shin, Jaeho; Untaroiu, Costin D

2011-08-01

To study the potential of active, passive, and integrated (combined active and passive) safety systems in reducing pedestrian upper body loading in typical impact configurations. Finite element simulations using models of generic sedan car fronts and the Polar II pedestrian dummy were performed for 3 impact configurations at 2 impact speeds. Chest contact force, head injury criterion (HIC(15)), head angular acceleration, and the cumulative strain damage measure (CSDM(0.25)) were employed as injury parameters. Further, 3 countermeasures were modeled: an active autonomous braking system, a passive deployable countermeasure, and an integrated system combining the active and passive systems. The auto-brake system was modeled by reducing impact speed by 10 km/h (equivalent to ideal full braking over 0.3 s) and introducing a pitch of 1 degree and in-crash deceleration of 1 g. The deployable system consisted of a deployable hood, lifting 100 mm in the rear, and a lower windshield air bag. All 3 countermeasures showed benefit in a majority of impact configurations in terms of injury prevention. The auto-brake system reduced chest force in a majority of the configurations and decreased HIC(15), head angular acceleration, and CSDM in all configurations. Averaging all impact configurations, the auto-brake system showed reductions of injury predictors from 20 percent (chest force) to 82 percent (HIC). The passive deployable countermeasure reduced chest force and HIC(15) in a majority of configurations and head angular acceleration and CSDM in all configurations, although the CSDM decrease in 2 configurations was minimal. On average a reduction from 20 percent (CSDM) to 58 percent (HIC) was recorded in the passive deployable countermeasures. Finally, the integrated system evaluated in this study reduced all injury assessment parameters in all configurations compared to the reference situations. The average reductions achieved by the integrated system ranged from 56 percent (CSDM) to 85 percent (HIC). Both the active (autonomous braking) and passive deployable system studied had a potential to decrease pedestrian upper body loading. An integrated pedestrian safety system combining the active and passive systems increased the potential of the individual systems in reducing pedestrian head and chest loading.

Space Generic Open Avionics Architecture (SGOAA) reference model technical guide

NASA Technical Reports Server (NTRS)

Wray, Richard B.; Stovall, John R.

1993-01-01

This report presents a full description of the Space Generic Open Avionics Architecture (SGOAA). The SGOAA consists of a generic system architecture for the entities in spacecraft avionics, a generic processing architecture, and a six class model of interfaces in a hardware/software system. The purpose of the SGOAA is to provide an umbrella set of requirements for applying the generic architecture interface model to the design of specific avionics hardware/software systems. The SGOAA defines a generic set of system interface points to facilitate identification of critical interfaces and establishes the requirements for applying appropriate low level detailed implementation standards to those interface points. The generic core avionics system and processing architecture models provided herein are robustly tailorable to specific system applications and provide a platform upon which the interface model is to be applied.

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.

Impact on Bacterial Resistance of Therapeutically Nonequivalent Generics: The Case of Piperacillin-Tazobactam

PubMed Central

Rodriguez, Carlos A.; Agudelo, Maria; Aguilar, Yudy A.; Zuluaga, Andres F.

2016-01-01

Previous studies have demonstrated that pharmaceutical equivalence and pharmacokinetic equivalence of generic antibiotics are necessary but not sufficient conditions to guarantee therapeutic equivalence (better called pharmacodynamic equivalence). In addition, there is scientific evidence suggesting a direct link between pharmacodynamic nonequivalence of generic vancomycin and promotion of resistance in Staphylococcus aureus. To find out if even subtle deviations from the expected pharmacodynamic behavior with respect to the innovator could favor resistance, we studied a generic product of piperacillin-tazobactam characterized by pharmaceutical and pharmacokinetic equivalence but a faulty fit of Hill’s Emax sigmoid model that could be interpreted as pharmacodynamic nonequivalence. We determined the impact in vivo of this generic product on the resistance of a mixed Escherichia coli population composed of ∼99% susceptible cells (ATCC 35218 strain) and a ∼1% isogenic resistant subpopulation that overproduces TEM-1 β-lactamase. After only 24 hours of treatment in the neutropenic murine thigh infection model, the generic amplified the resistant subpopulation up to 20-times compared with the innovator, following an inverted-U dose-response relationship. These findings highlight the critical role of therapeutic nonequivalence of generic antibiotics as a key factor contributing to the global problem of bacterial resistance. PMID:27191163

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.

Level of psychosocial adaptation in young school children with otitis media.

PubMed

Timmerman, Angelique; Meesters, Cor; Anteunis, Lucien; Chenault, Mickey

2007-12-01

Assessment of the level of psychosocial adaptation in Dutch young school children with persistent and/or recurrent otitis media compared to a U.S. community sample. The goal of this study was to determine the presence of behavioural effects related to a history of hearing loss resulting from recurrent or persistent otitis media. Caregivers of 160 children, age range 4-7 years, suffering from either upper respiratory tract infections (URTI) and/or otitis media with effusion (OME), completed the generic Strengths and Difficulties Questionnaire (SDQ) and impact supplement before consulting the ENT physician. In the ENT sample significant differences were found for the SDQ subscales hyperactivity-inattention and emotional symptoms, as well as for the total difficulties score and impact rating, compared to the U.S. community sample (p<.0005). Classification of severity (low, medium, high difficulties) for SDQ symptom scores, according to U.S. normative scoring bands, showed significantly more children in higher severity bands for SDQ total difficulties (p<.0005), emotional symptoms (p<.005), hyperactivity-inattention (p<.001) and prosocial behaviour (p<.005). This is expressed in a larger percentage of scores in the high difficulties (>90% of scores) than in the medium difficulties (80-90% of scores) band for most ENT SDQ scores, except for SDQ prosocial behaviour (18.1%) and total difficulties (17.5%). The level of psychosocial adaptation seems to be compromised in the Dutch ENT sample for both internalising (emotional symptoms) and externalising (hyperactivity-inattention) behaviour dimensions, which indirectly supports the cumulative effects of a disease history with chronic otitis media, resulting in poorer attention skills and fewer social interactions present. The classification of SDQ symptom severity, indicates that any behavioural effect of otitis media and resulting hearing loss is within the borderline score range, asking for vigilance regarding possible developmental and educational sequelae during childhood.

Understanding and perceptions of final-year Doctor of Pharmacy students about generic medicines in Karachi, Pakistan: a quantitative insight

PubMed Central

Jamshed, Shazia Qasim; Ibrahim, Mohamad Izham Mohamad; Hassali, Mohamad Azmi; Sharrad, Adheed Khalid; Shafie, Asrul Akmal; Babar, Zaheer-Ud-Din

2015-01-01

General objective To evaluate the understanding and perceptions of generic medicines among final-year Doctor of Pharmacy students in Karachi, Pakistan. Methods A 23-item survey instrument that included a question on the bioequivalence limits and Likert-type scale questions regarding the understanding and perceptions of generic medicines among the students was executed. Cronbach’s alpha was found to be 0.62. Results Responses were obtained from 236 final-year Doctor of Pharmacy students (n=85 from a publicly funded institute; n=151 from a privately funded institute). When comparing a brand-name medicine to a generic medicine, pharmacy students scored poorly on bioequivalence limits. More than 80% of the students incorrectly answered that all the products that are rated as generic equivalents are therapeutically equivalent to each other (P<0.04). Half of the students agreed that a generic medicine is bioequivalent to the brand-name medicine (P<0.001). With regard to quality, effectiveness, and safety, more than 75% of the students disagreed that generic medicines are of inferior quality and are less effective than brand-name medicines (P<0.001). More than 50% of the students disagreed that generic medicines produce more side effects than brand-name medicines (P<0.001). Conclusion The current study identified a positive perception toward generic medicines but also gaps in the understanding of generic medicines. Pharmacy students lacked a thorough understanding of the concepts of bioequivalence. Pharmacy academia should address these issues, which will help build confidence in generic medicines and increase the generic medicine use in Pakistan. PMID:26028981

Primary Sjögren's syndrome in Moroccan patients: characteristics, fatigue and quality of life.

PubMed

Ibn Yacoub, Yousra; Rostom, Samira; Laatiris, Assia; Hajjaj-Hassouni, Najia

2012-09-01

Our aim was to evaluate fatigue and quality of life (QoL) in Moroccan patients with primary Sjögren's syndrome (PSS) and determine their correlates with disease-related parameters. Fifty-seven consecutive patients with PSS according to the American-European Consensus group (AEGG) criteria were included. Demographic, clinical, biological and immunological characteristics for all patients were collected. Xerostomia was demonstrated by histological grading of lower lip glandular biopsy. A Schirmer test was performed to measure lachrymal flow. Oral, ocular, skin, vaginal and tracheal dryness were evaluated by using a visual analogue scale (VAS). Fatigue was assessed by the Multidimensional assessment of fatigue (MAF) and the QoL by using the generic instrument: SF-36. 90% of our patients were women. The mean age of patients was 53.73 ± 7.69 years, and the mean disease duration was 5.38 ± 4.11 years. The mean oral dryness was 68.38 ± 20.29, and the mean ocular dryness was 51.91 ± 14.03. The mean total score of the MAF was 26.73 ± 8.33, and 87.5% of our patients experienced severe fatigue. Also, physical and mental domains of QoL were altered in a significant way, and the severity of fatigue had a negative impact on SF-36 scores. MAF and SF-36 scores were correlated with the delay of diagnosis, the intensity of xerostomia and the activity of joint involvement. A low socioeconomic and educational level had a negative impact on fatigue scores and QoL. Histological grading of lower lip glandular biopsy, immunological status and the severity of systemic involvement had no correlations with fatigue scores or the alteration of QoL. Patients receiving antidepressant have lesser fatigue and those receiving Methotrexate have better SF-36 scores. In our data, there was a high prevalence of fatigue in Moroccan patients with PSS associated with altered QoL. Severe fatigue and reduced QoL seem to be related to the severity of joint involvement, xerostomia and both educational and socioeconomic levels. Also, treatment with methotrexate and antidepressant seems to improve patients' living and QoL. An appropriate therapeutic intervention for depression and articular manifestations in PSS should be applied to improve patients' living.

The Association Between Length of Recovery Following Sport-Related Concussion and Generic and Specific Health-Related Quality of Life in Adolescent Athletes: A Prospective, Longitudinal Study.

PubMed

Valovich McLeod, Tamara; Bay, R Curtis; Lam, Kenneth C; Snyder Valier, Alison R

2018-05-31

Our purpose was to determine the association between concussion recovery and health-related quality of life (HRQOL). Secondary school athletic training facilities. Patients (N = 122) with a concussion. Prospective, longitudinal cohort. The Pediatric Quality-of-Life Inventory (PedsQL), PedsQL Multidimensional Fatigue Scale (MFS), and Headache Impact Test-6 (HIT-6) were completed at preseason and days 3 (D3), 10 (D10), and 30 (D30) postconcussion. The independent variable was the recovery group. Interactions between group and time (P < .001) were noted for all PedsQL subscales, except Social Functioning (P = .75). Significantly lower scores were found among Prolonged than in Short on D3 (P < .05). Significant interactions (P < .001) were also noted for all MFS subscales. Pairwise comparisons for General and Sleep subscales revealed Prolonged had lower scores than Short and Moderate on D3 and D10. A group by time interaction was found for the HIT-6 (P < .001), with scores being higher (P < .01) in Prolonged than in Short on D3 and D10. Adolescents with a prolonged recovery demonstrated lower HRQOL in the immediate days postinjury, particularly in physical and school functioning, fatigue, and headache. There was a strong association between recovery length and school functioning. Additional research is needed to understand how to minimize the impact of concussion on HRQOL.

Impact of end effector technology on telemanipulation performance

NASA Technical Reports Server (NTRS)

Bejczy, A. K.; Szakaly, Z.; Ohm, T.

1990-01-01

Generic requirements for end effector design are briefly summarized as derived from generic functional and operational requirements. Included is a brief summary of terms and definitions related to end effector technology. The second part contains a brief overview of end effector technology work as JPL during the past ten years, with emphasis on the evolution of new mechanical, sensing and control capabilities of end effectors. The third and major part is devoted to the description of current end effector technology. The ongoing work addresses mechanical, sensing and control details with emphasis on mechanical ruggedness, increased resolution in sensing, and close electronic and control integration with overall telemanipulator control system.

[The patents game. Generic and biosimilar drugs].

PubMed

Villamañán, E; González, D; Armada, E; Ruano, M; Álvarez-Sala, R; Herrero, A

2016-01-01

The protection provided by patents on medicines has a limited duration. The expiry of patents expiration allows copies of the drugs to be released, competing with original. At first, they were identical to the original, known as generic drugs, but in recent years, due to the marketing of biological therapies and the expiry of many of their patents, biosimilar drugs have also emerged. These are not exact copies of the original, but, like generic drugs, biosimilar drugs have to demonstrate equivalence to the reference drugs in quality, safety and efficacy. Nevertheless, despite their importance and contribution to sustainability of health system, doctors are sometimes unaware of differences between them, and their impact in terms of clinical and economic effects. An attempt is made to review and clarify certain aspects often unknown by physicians, despite their involvement in their use. Copyright © 2015 SECA. Published by Elsevier Espana. All rights reserved.

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.

Economic impact of generic substitution of lamotrigine: projected costs in the US using findings in a Canadian setting.

PubMed

LeLorier, Jacques; Duh, Mei Sheng; Paradis, Pierre Emmanuel; Latrémouille-Viau, Dominick; Lefebvre, Patrick; Manjunath, Ranjani; Sheehy, Odile

2008-04-01

Generic substitution may not always save health care costs for antiepileptic drugs (AED). (1) To examine the economic impacts of generic substitution of lamotrigine in Canada; and (2) to convert observed Canadian costs to a United States (US) setting. Health claims from Québec's health plan (RAMQ) between 08/2002 and 07/2006 were analyzed. Patients with > or = 1 epilepsy claim and treated with branded lamotrigine (Lamictal) before generic entry were selected. Health care costs ($/person-year) were compared during periods of branded and generic use of lamotrigine. Two cost-conversion methods were employed; one using purchasing power parities, US/Canada service use ratios, and exchange rate, and another employing Canadian health care utilization and US unit costs. 671 patients were observed during 1650.9 and 291.2 person-years of branded and generic use of lamotrigine, respectively. The generic-use period was associated with an increase in overall costs (2006 constant Canadian dollars) relative to brand use (C$7902 vs. C$6419/person-year; cost ratio (CR) = 1.22; p = 0.05), despite the lower cost of generic lamotrigine. Non-lamotrigine costs were 33% higher in the generic period (p = 0.013). Both conversion methods yielded increases in total projected health care costs excluding lamotrigine (2006 constant US dollars) during the generic period (Method 1: cost difference: US$1758/person-year, CR = 1.33, p = 0.01); Method 2: cost difference: US$2516, CR = 1.39, p = 0.004). Study limitations pertain to treatment differences, indicators used for conversion and possible claim inaccuracies. Use of generic lamotrigine in Canada was significantly associated with increased overall medical costs compared to brand use. Projected overall US health care costs would likely increase as well.

The Impact of Price-cap Regulations on Exit by Generic Pharmaceutical Firms.

PubMed

Zhang, Wei; Guh, Daphne; Sun, Huiying; Marra, Carlo A; Lynd, Larry D; Anis, Aslam H

2016-09-01

In 1998, the Province of Ontario in Canada adopted price-cap "70/90" regulations whereby the first generic entrant was required to be priced at ≤70% of the associated brand-name product and subsequent generics were priced at ≤90% of the first generic price. The price-caps were further lowered to 50% in 2006 and 25% in 2010. This study assessed the impact of such price-cap regulations on exit by generic drug firms. Formulary (2003-2012) listings of prescription drugs covered under the Ontario Drug Benefit program were used. The formulary tracks the "status" (on formulary, discontinued by manufacturer, and delisted for other reasons) for each drug. Markets were defined based on unique active ingredient and form within Ontario. Firm exit occurred when a manufacturer discontinued all its generic drugs within a market. The exit rate was defined as the number of generic firm-market exits divided by total generic firm-market follow-up years. Poisson regression was used to compare the exit rates during the 3 policy periods ("25," "50," and "70/90"). A total of 1126 generic manufacturers paired with 290 markets were identified. The exit rate ratio during the 25% price-cap period compared with the 70%/90% period was 2.42 (95% confidence interval, 1.56-3.77). A small manufacturer or a manufacturer in a market with ≥3 competitors or in an older market was more likely to exit. Lowering the price-cap level is associated with a higher incidence of generic firm exit from markets. Continuously reducing price-caps may have the unintended consequence of forcing generic firms to exit.

Selegiline shortage: Causes and costs of a generic drug shortage.

PubMed

Dorsey, E R; Thompson, J P; Dayoub, E J; George, B; Saubermann, L A; Holloway, R G

2009-07-21

In September 2007, shortages of generic selegiline occurred, forcing patients to either switch to more expensive alternatives or forego treatment. We sought to evaluate prescription trends of generic selegiline and to quantify the economic impact of any resulting drug substitution of more expensive alternatives. We analyzed proprietary data from IMS Health on monthly prescriptions in the United States for selegiline and potential substitutes from February 2002 through December 2007. Linear regression was used to predict the number of expected prescriptions after August 2007 had a shortage not occurred. The main outcome measures were the changes in prescriptions filled and the economic impact of drug substitution. Prior to the shortage, total prescriptions filled for generic selegiline decreased 42%, and supply consolidated into one company, Apotex Inc., Toronto, Canada, whose market share increased from 41% to 83%. During the first 4 months of the shortage, Apotex Inc. filled 10,500 fewer prescriptions than projected and other selegiline manufacturers filled 7,400 more than projected for a net shortage of 3,100 prescriptions. The number of branded selegiline capsules filled during this period increased by 1,800 above projections, and 1,300 prescriptions for generic selegiline were not refilled or substituted. The societal cost of substituting generic selegiline with branded capsules was $75,000 over the first 4 months of the shortage. Generic drug shortages carry economic and health implications. Given ongoing consolidation in the generics drug industry, these shortages may become more common and may require heightened regulatory scrutiny of the generic drug industry.

Impact of brand or generic labeling on medication effectiveness and side effects.

PubMed

Faasse, Kate; Martin, Leslie R; Grey, Andrew; Gamble, Greg; Petrie, Keith J

2016-02-01

Branding medication with a known pharmaceutical company name or product name bestows on the drug an added assurance of authenticity and effectiveness compared to a generic preparation. This study examined the impact of brand name and generic labeling on medication effectiveness and side effects. 87 undergraduate students with frequent headaches took part in the study. Using a within-subjects counterbalanced design, each participant took tablets labeled either as brand name "Nurofen" or "Generic Ibuprofen" to treat each of 4 headaches. In reality, half of the tablets were placebos, and half were active ibuprofen (400 mg). Participants recorded their headache pain on a verbal descriptor and visual analogue scale prior to taking the tablets, and again 1 hour afterward. Medication side effects were also reported. Pain reduction following the use of brand name labeled tablets was similar in active ibuprofen or a placebo. However, if the tablets had a generic label, placebo tablets were significantly less effective compared to active ibuprofen. Fewer side effects were attributed to placebo tablets with brand name labeling compared to the same placebo tablets with a generic label. Branding of a tablet appears to have conferred a treatment benefit in the absence of an active ingredient, while generic labeled tablets were substantially less effective if they contained no active ingredient. Branding is also associated with reduced attribution of side effects to placebo tablets. Future interventions to improve perceptions of generics may have utility in improving treatment outcomes from generic drugs. (c) 2016 APA, all rights reserved).

Returns to scientific publications for pharmaceutical products in the United States.

PubMed

Slejko, Julia F; Basu, Anirban; Sullivan, Sean D

2018-02-01

Drug-specific clinical and health economic and outcomes research (HEOR) publications have amassed, but their effect on drug sales is largely unknown. We estimated the impact of publications on pharmaceutical sales in 3 markets (statins, rheumatoid arthritis, and asthma drugs) with varying generic competition. An event-study approach with fixed effects and difference-in-fixed-effects modeling was used to estimate the causal effects of drug-specific publications on subsequent quarter's drug-specific sales and volume. High-impact clinical and HEOR publications have significant positive effects on sales (mediated through price) and volume in the statin market (high generic competition). High-impact clinical publications have a significant positive effect on sales (mediated through volume) in low-generic competition market (asthma). The effects of publications in the rheumatoid arthritis market (no generic competition) on sales were null. Manufacturers' investment in clinical and HEOR publications needs to be strategic and should be anticipated and complemented by public investments in such studies. Copyright © 2017 John Wiley & Sons, Ltd.

Relationship between fatigue, perfectionism, and functional dysphonia.

PubMed

O'Hara, James; Miller, Tracey; Carding, Paul; Wilson, Janet; Deary, Vincent

2011-06-01

Increased levels of fatigue and perfectionism were noted during evaluation of cognitive behavioral therapy for the treatment of functional dysphonia. The investigators thus aimed to explore levels of general fatigue and perfectionism in patients with functional dysphonia and controls. Case-control study. Teaching hospital, United Kingdom. Patients recruited through speech therapy were asked to recruit a friend as a control, of the same sex and within 5 years of their age. An 11-point fatigue questionnaire, previously validated on a normal population, was analyzed using both Likert (0123) and bimodal (0011) systems, with a score greater than 4 on the bimodal system implying substantial fatigue. A 35-point perfectionism questionnaire was also completed and analyzed for "healthy" and "unhealthy" perfectionist traits. There were 75 cases and 62 controls. The mean fatigue score in patients with functional dysphonia was 17.0 and 14.4 for the controls (Likert, P = .009). Under the bimodal scoring system, the mean fatigue scores in functional dysphonia (5.10) and controls (3.01) were also significantly different (P = .003). The mean perfectionism scores were 98.9 for patients with functional dysphonia and 91.2 for controls (P = 0.043). To the investigators' knowledge, this is the first substantial report that fatigue and perfectionism scores are significantly elevated in functional dysphonia. Functional dysphonia is shown to be analogous to other medically unexplained physical symptoms that are also marked by generic somatopsychic distress and for which multiple factors are implicated in their onset and maintenance. This has implications for both research and treatment.

Utilization and costs of HIV antiretroviral drugs in Europe during the last ten years: Impact of generic antiretroviral drugs on cost reduction.

PubMed

Rwagitinywa, Joseph; Sommet, Agnès; Palmaro, Aurore; Montastruc, Jean-Louis; Lapeyre-Mestre, Maryse

2018-03-01

Simulation studies showed that generic antiretroviral (ARV) drug utilization could lead to significant cost reduction of HIV treatment in developed world. This study aimed to quantify ARV utilization and costs in European countries between 2006 and 2015. We also assessed the impact of generic ARV drug utilization on cost reduction in real-life. ARV drug utilization in 14 European countries (France, Italy, Germany, Denmark, Netherlands, Norway, Sweden, Finland, Iceland, Croatia, Czech Republic, Estonia, Latvia, and Lithuania) were analysed using defined daily dose (DDD)/1000 inhabitants/year. ARV drug cost was estimated in million euro/year and euro/1000 inhabitants/year. The impact of generics on cost reduction was assessed in three countries: France, Denmark, and Czech Republic, using four parameters: expected savings, observed savings, brand price-reduction savings and overall savings. Between 2006 and 2015, median ARV drug utilization increased from 234 DDDs per 1000 inhabitants per year (IQR 124-388) to 385 (229-670). The median cost increased from €3751/1000 inhabitants/year (1109-4681) to €9158 (3269-10,646). Between 2013 and 2015, overall savings of €0.9, €1.6, and €33.7 million were respectively observed in Denmark, Czech Republic, and France. Overall savings observed in real-life from generic ARV drugs in Denmark were related to high rate of low-price generic utilization, contrarily to France and Czech Republic where these were more related to brand price-reduction than generic utilization itself. Copyright © 2018 Elsevier B.V. All rights reserved.

The tissue microarray data exchange specification: Extending TMA DES to provide flexible scoring and incorporate virtual slides

PubMed Central

Wright, Alexander; Lyttleton, Oliver; Lewis, Paul; Quirke, Philip; Treanor, Darren

2011-01-01

Background: Tissue MicroArrays (TMAs) are a high throughput technology for rapid analysis of protein expression across hundreds of patient samples. Often, data relating to TMAs is specific to the clinical trial or experiment it is being used for, and not interoperable. The Tissue Microarray Data Exchange Specification (TMA DES) is a set of eXtensible Markup Language (XML)-based protocols for storing and sharing digitized Tissue Microarray data. XML data are enclosed by named tags which serve as identifiers. These tag names can be Common Data Elements (CDEs), which have a predefined meaning or semantics. By using this specification in a laboratory setting with increasing demands for digital pathology integration, we found that the data structure lacked the ability to cope with digital slide imaging in respect to web-enabled digital pathology systems and advanced scoring techniques. Materials and Methods: By employing user centric design, and observing behavior in relation to TMA scoring and associated data, the TMA DES format was extended to accommodate the current limitations. This was done with specific focus on developing a generic tool for handling any given scoring system, and utilizing data for multiple observations and observers. Results: DTDs were created to validate the extensions of the TMA DES protocol, and a test set of data containing scores for 6,708 TMA core images was generated. The XML was then read into an image processing algorithm to utilize the digital pathology data extensions, and scoring results were easily stored alongside the existing multiple pathologist scores. Conclusions: By extending the TMA DES format to include digital pathology data and customizable scoring systems for TMAs, the new system facilitates the collaboration between pathologists and organizations, and can be used in automatic or manual data analysis. This allows complying systems to effectively communicate complex and varied scoring data. PMID:21572508

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.

The impact of Early Warning Score and Rapid Response Systems on nurses' competence: An integrative literature review and synthesis.

PubMed

Jensen, Jørghild Karlotte; Skår, Randi; Tveit, Bodil

2018-04-01

To describe, interpret and synthesise the current research findings on the impact of the Early Warning Score and Rapid Response Systems on nurses' competence in identifying and managing deteriorating patients in general hospital wards. As patient safety initiatives designed to ensure the early identification and management of deteriorating patients, the Early Warning Score and Rapid Response Systems have broad appeal. However, it is still unclear how these systems impact nurses' competence when these systems are used in general hospital wards. CINAHL, PubMed, Cochrane, EMBASE and Ovid MEDLINE databases were systematically searched for relevant articles. Articles were appraised, a thematic analysis was conducted, and similar and divergent perspectives on emergent themes and subthemes were extracted by a team of researchers. Thirty-six studies met the inclusion criteria. The analysis of findings showed how the Early Warning Score and Rapid Response Systems impacted three competence areas: (i) Nurses' competence in assessing and caring for patients related to the subthemes: (a) sensing clinical deterioration and (b) the development of skills and knowledge. (ii). Nurses' competence in referring patients, related to the subthemes: (a) deciding whether to summon help and (b) the language and communication lines in the referral process. (ii) Nurses' coping and mastery experiences. The impact of the Early Warning Score and Rapid Response Systems on nurses' competence in identifying and managing deteriorating patients is beneficial but also somewhat contradictory. A greater understanding of nurses' development of competence when using the Early Warning Score and Rapid Response Systems will facilitate the design of implementation strategies and the use of these systems to improve practice. © 2017 John Wiley & Sons Ltd.

Potential Demand for Orbital Space Tourism Opportunities Made Available via Reusable Rocket and Hypersonic Architectures

DTIC Science & Technology

2010-06-01

Corporation has conducted several comparative studies for SSTO and TSTO system options using Rockets and Airbreather cycles, for both Horizontal...compared as they have less impact on size due to generic uncertainties and tend to be more robust compared to SSTO options. As called for by and in

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.

Proposal for a novel methodology to screen and score cost versus survival for anticancer drugs in metastatic disease: could cost weigh in evaluation?

PubMed

Guirgis, Helmy M

2012-07-01

Rising costs of anticancer drugs prompt concerns about their approval, use, and affordability. A methodology was developed to evaluate cost versus survival for anticancer drugs in metastatic breast cancer and non-small-cell lung cancer (NSCLC). Costs of evaluated drugs were calculated by using average wholesale prices in US dollars. Ratios of cost to day of survival (cost/survival/d) were obtained by dividing costs of the entire treatment by reported median survival gain in days. A crude score of 100% was assigned to a cost/survival/d of less than $25, and 0% to a cost/survival/d of more than $750. A strategy was designed to correct for overall survival (OS) versus progression-free survival (PFS), adverse effects, and quality of life. In breast cancer, PFS scores of bevacizumab varied between 0% and 60%. In NSCLC, OS scores of bevacizumab improved from 0% to 50%, as a result of histology, lower prices, and extended therapy. Gefitinib and erlotinib PFS scores were 80% and 70%, respectively. Correction for longer survival with erlotinib resulted in similar scores. In maintenance therapy, the OS score for pemetrexed was 70% as compared with 25% for erlotinib. Generic drugs scored 70% to 90%. Cost/survival varied with the number of cycles. In breast cancer, bevacizumab scores failed to justify its use. In NSCLC, 10 cycles of bevacizumab scored 0%. Scores improved with extended treatment and lower prices. Scores for gefitinib and erlotinib would support their approval. Erlotinib was preferred because of longer PFS. Results tended to endorse maintenance pemetrexed but not erlotinib. Generic drugs demonstrated high scores. Cost/survival could weigh in drug evaluation.

Construct Validity and Responsiveness of the Pediatric Quality of Life Inventory 4.0 Generic Core Scales and Infant Scales in the PICU.

PubMed

Aspesberro, François; Fesinmeyer, Megan D; Zhou, Chuan; Zimmerman, Jerry J; Mangione-Smith, Rita

2016-06-01

To assess the construct validity and the responsiveness of the Pediatric Quality of Life Inventory 4.0 Generic Core Scales and Infant Scales in the medical-surgical (PICU) and cardiac PICU. Prospective cohort study of 367 inpatients admitted either to the PICU or the cardiac ICU at Seattle Children's Hospital from January 2012 to June 2013. Parent/caregiver and child (≥ 8 yr old, developmentally appropriate, and critical illness resolved) Pediatric Quality of Life Inventory scores were obtained within 24 hours of PICU/cardiac ICU discharge and subsequently at 4-12 weeks following hospital discharge. Of the 491 eligible participants invited to participate, 367 (74.7% response rate) completed the Pediatric Quality of Life Inventory survey at ICU discharge, and of these, 263 (71.7% follow-up response rate) completed the follow-up survey 4-12 weeks after hospital discharge. Responsiveness was assessed by calculating improvement scores (difference between follow-up and ICU discharge scores, Δ Pediatric Quality of Life Inventory). Construct validity was examined by comparing mean improvement scores for known groups differing by medical complexity. At follow-up, [INCREMENT] Pediatric Quality of Life Inventory scores were as follows (mean ± SD): physical domain, 34.8 ± 32.0; and psychosocial domain, 23.1 ± 23.5. Patients with complex chronic or noncomplex chronic disease had physical functioning improvement scores that were 17.4 points (95% CI, -28.3 to -6.5; p < 0.001) and 19.5 points (95% CI, -30.4 to -8.5; p < 0.002) lower than children with no chronic illness, respectively. Patients with complex chronic disease exhibited psychosocial improvement scores that were 9.6 points (95% CI, -18.4 to -0.8; p < 0.033) lower than patients without chronic disease. Patients with noncomplex chronic disease had similar psychosocial improvement scores when compared with patients without chronic disease. As a measure of health-related quality of live, Pediatric Quality of Life Inventory demonstrated responsiveness and construct validity in a broad population of critically ill children. This measure represents a patient-centered clinically meaningful patient-or-parent-reported outcome measure for pediatric research assessing the clinical effectiveness of PICU/cardiac ICU interventions. When using health-related quality of life recovery as an outcome measure to assess clinical effectiveness in the PICU/cardiac ICU setting, measuring and controlling for the level of medical complexity is important in order to understand the true impact of clinical interventions.

A Generic Expert Scheduling System Architecture and Toolkit: GUESS (Generically Used Expert Scheduling System)

NASA Technical Reports Server (NTRS)

Liebowitz, Jay; Krishnamurthy, Vijaya; Rodens, Ira; Houston, Chapman; Liebowitz, Alisa; Baek, Seung; Radko, Joe; Zeide, Janet

1996-01-01

Scheduling has become an increasingly important element in today's society and workplace. Within the NASA environment, scheduling is one of the most frequently performed and challenging functions. Towards meeting NASA's scheduling needs, a research version of a generic expert scheduling system architecture and toolkit has been developed. This final report describes the development and testing of GUESS (Generically Used Expert Scheduling System).

A joint signal processing and cryptographic approach to multimedia encryption.

PubMed

Mao, Yinian; Wu, Min

2006-07-01

In recent years, there has been an increasing trend for multimedia applications to use delegate service providers for content distribution, archiving, search, and retrieval. These delegate services have brought new challenges to the protection of multimedia content confidentiality. This paper discusses the importance and feasibility of applying a joint signal processing and cryptographic approach to multimedia encryption, in order to address the access control issues unique to multimedia applications. We propose two atomic encryption operations that can preserve standard compliance and are friendly to delegate processing. Quantitative analysis for these operations is presented to demonstrate that a good tradeoff can be made between security and bitrate overhead. In assisting the design and evaluation of media security systems, we also propose a set of multimedia-oriented security scores to quantify the security against approximation attacks and to complement the existing notion of generic data security. Using video as an example, we present a systematic study on how to strategically integrate different atomic operations to build a video encryption system. The resulting system can provide superior performance over both generic encryption and its simple adaptation to video in terms of a joint consideration of security, bitrate overhead, and friendliness to delegate processing.

Analysis of Spanish generic medicines retail market: recommendations to enhance long-term sustainability.

PubMed

Dylst, Pieter; Vulto, Arnold G; Simoens, Steven

2014-06-01

The use of generic medicines in Spain is traditionally low compared to other European countries, despite efforts of the Spanish government in the past. This paper provides a perspective on the Spanish generic medicines retail market and how the current policy environment may affect the long-term sustainability. The Spanish government's focus on prices of generic medicines (e.g., mandatory price cuts, reference price set at the lowest level) have made them amongst the lowest in Europe. In our opinion, this combination of continuous pressure on prices and limited diffusion of generic medicines may undermine the long-term sustainability of the Spanish generic medicines retail market. The unique experience in Spain shows the impact of demand-side policies on the use of generic medicines. Because a sustainable generic medicines retail market is important to maintain future competition in the off-patent medicines market, this perspective paper rounds off with recommendations to increase its sustainability.

Development of an item bank and computer adaptive test for role functioning.

PubMed

Anatchkova, Milena D; Rose, Matthias; Ware, John E; Bjorner, Jakob B

2012-11-01

Role functioning (RF) is a key component of health and well-being and an important outcome in health research. The aim of this study was to develop an item bank to measure impact of health on role functioning. A set of different instruments including 75 newly developed items asking about the impact of health on role functioning was completed by 2,500 participants. Established item response theory methods were used to develop an item bank based on the generalized partial credit model. Comparison of group mean bank scores of participants with different self-reported general health status and chronic conditions was used to test the external validity of the bank. After excluding items that did not meet established requirements, the final item bank consisted of a total of 64 items covering three areas of role functioning (family, social, and occupational). Slopes in the bank ranged between .93 and 4.37; the mean threshold range was -1.09 to -2.25. Item bank-based scores were significantly different for participants with and without chronic conditions and with different levels of self-reported general health. An item bank assessing health impact on RF across three content areas has been successfully developed. The bank can be used for development of short forms or computerized adaptive tests to be applied in the assessment of role functioning as one of the common denominators across applications of generic health assessment.

Socio-demographic, clinical characteristics and utilization of mental health care services associated with SF-6D utility scores in patients with mental disorders: contributions of the quantile regression.

PubMed

Prigent, Amélie; Kamendje-Tchokobou, Blaise; Chevreul, Karine

2017-11-01

Health-related quality of life (HRQoL) is a widely used concept in the assessment of health care. Some generic HRQoL instruments, based on specific algorithms, can generate utility scores which reflect the preferences of the general population for the different health states described by the instrument. This study aimed to investigate the relationships between utility scores and potentially associated factors in patients with mental disorders followed in inpatient and/or outpatient care settings using two statistical methods. Patients were recruited in four psychiatric sectors in France. Patient responses to the SF-36 generic HRQoL instrument were used to calculate SF-6D utility scores. The relationships between utility scores and patient socio-demographic, clinical characteristics, and mental health care utilization, considered as potentially associated factors, were studied using OLS and quantile regressions. One hundred and seventy six patients were included. Women, severely ill patients and those hospitalized full-time tended to report lower utility scores, whereas psychotic disorders (as opposed to mood disorders) and part-time care were associated with higher scores. The quantile regression highlighted that the size of the associations between the utility scores and some patient characteristics varied along with the utility score distribution, and provided more accurate estimated values than OLS regression. The quantile regression may constitute a relevant complement for the analysis of factors associated with utility scores. For policy decision-making, the association of full-time hospitalization with lower utility scores while part-time care was associated with higher scores supports the further development of alternatives to full-time hospitalizations.

Adherence to Mediterranean diet and risk of developing cognitive disorders: An updated systematic review and meta-analysis of prospective cohort studies

PubMed Central

Wu, Lei; Sun, Dali

2017-01-01

Recent articles have presented inconsistent findings on the impact of Mediterranean diet in the occurrence of cognitive disorders; therefore, we performed an updated systematic review and meta-analysis to evaluate the potential association and dose-response pattern with accumulating evidence. We searched the PubMed and the Embase for the records relevant to this topic. A generic inverse-variance method was used to pool the outcome data for continuous variable, and categories of high vs. low, median vs. low of Mediterranean diet score with a random-effects model. Generalized least-squares trend estimation model was used to estimate the potential dose-response patterns of Mediterranean diet score on incident cognitive disorders. We identified 9 cohort studies involving 34,168 participants. Compared with the lowest category, the pooled analysis showed that the highest Mediterranean diet score was inversely associated with the developing of cognitive disorders, and the pooled RR (95% CI) was 0.79 (0.70, 0.90). Mediterranean diet score of the median category was not significantly associated with cognitive disorders. Dose-response analysis indicated a trend of an approximately linear relationship of the Mediterranean diet score with the incident risk of cognitive disorders. Further studies of randomized controlled trials are warranted to confirm the observed association in different populations. PMID:28112268

From Gain Score t to ANCOVA F (and Vice Versa)

ERIC Educational Resources Information Center

Knapp, Thomas R.; Schafer, William D.

2009-01-01

Although they test somewhat different hypotheses, analysis of gain scores (or its repeated-measures analog) and analysis of covariance are both common methods that researchers use for pre-post data. The results of the two approaches yield non-comparable outcomes, but since the same generic data are used, it is possible to transform the test…

Contact centers, pervasive computing and telemedicine: a quality health care triangle.

PubMed

Maglaveras, Nicos

2004-01-01

The Citizen Health System (CHS) is a European Commission (CEC) funded project in the field of IST for Health. Its main goal is to develop a generic contact center which in its pilot stage can be used in the monitoring, treatment and management of chronically ill patients at home in Greece, Spain, and Germany. Such contact centers, using any type of communication technology, and providing timely and preventive prompting to the patients are envisaged in the future to evolve into well-being contact centers providing services to all citizens. In this paper, we present the structure of such a generic contact center and present its major achievements, and their impact to the quality of health delivery.

Do generic utility measures capture what is important to the quality of life of people with multiple sclerosis?

PubMed

Kuspinar, Ayse; Mayo, Nancy E

2013-04-25

The three most widely used utility measures are the Health Utilities Index Mark 2 and 3 (HUI2 and HUI3), the EuroQol-5D (EQ-5D) and the Short-Form-6D (SF-6D). In line with guidelines for economic evaluation from agencies such as the National Institute for Health and Clinical Excellence (NICE) and the Canadian Agency for Drugs and Technologies in Health (CADTH), these measures are currently being used to evaluate the cost-effectiveness of different interventions in MS. However, the challenge of using such measures in people with a specific health condition, such as MS, is that they may not capture all of the domains that are impacted upon by the condition. If important domains are missing from the generic measures, the value derived will be higher than the real impact creating invalid comparisons across interventions and populations. Therefore, the objective of this study is to estimate the extent to which generic utility measures capture important domains that are affected by MS. The available study population consisted of men and women who had been registered after 1994 in three participating MS clinics in Greater Montreal, Quebec, Canada. Subjects were first interviewed on an individualized measure of quality of life (QOL) called the Patient Generated Index (PGI). The domains identified with the PGI were then classified and grouped together using the World Health Organization's International Classification of Functioning, Disability and Health (ICF), and mapped onto the HUI2, HUI3, EQ-5D and SF-6D. A total of 185 persons with MS were interviewed on the PGI. The sample was relatively young (mean age 43) and predominantly female. Both men and women had mild disability with a median Expanded Disability Status Scale (EDSS) score of 2. The top 10 domains that patients identified to be the most affected by their MS were, work (62%), fatigue (48%), sports (39%), social life (28%), relationships (23%), walking/mobility (22%), cognition (21%), balance (14%), housework (12%) and mood (11%). The SF-6D included the most number of domains (6 domains) important to people with MS, followed by the EQ-5D (4 domains) and the HUI2 (4 domains) and then the HUI3 (3 domains). The mean and standard deviation (SD) for the PGI, EQ-5D and the SF-6D were 0.50 (SD 0.25), 0.69 (0.18) and 0.69 (0.13), respectively. The magnitude of difference between the PGI and the generic utility measures was large and statistically significant. Although the generic utility measures included certain items that were important to people with MS, there were several that were missing. An important consequence of this mismatch was that values of QOL derived from the PGI were importantly and significantly lower than those estimated using any of the generic utility measures. This could have a substantial impact in evaluating the effect of interventions for people with MS.

Do generic utility measures capture what is important to the quality of life of people with multiple sclerosis?

PubMed Central

2013-01-01

Purpose The three most widely used utility measures are the Health Utilities Index Mark 2 and 3 (HUI2 and HUI3), the EuroQol-5D (EQ-5D) and the Short-Form-6D (SF-6D). In line with guidelines for economic evaluation from agencies such as the National Institute for Health and Clinical Excellence (NICE) and the Canadian Agency for Drugs and Technologies in Health (CADTH), these measures are currently being used to evaluate the cost-effectiveness of different interventions in MS. However, the challenge of using such measures in people with a specific health condition, such as MS, is that they may not capture all of the domains that are impacted upon by the condition. If important domains are missing from the generic measures, the value derived will be higher than the real impact creating invalid comparisons across interventions and populations. Therefore, the objective of this study is to estimate the extent to which generic utility measures capture important domains that are affected by MS. Methods The available study population consisted of men and women who had been registered after 1994 in three participating MS clinics in Greater Montreal, Quebec, Canada. Subjects were first interviewed on an individualized measure of quality of life (QOL) called the Patient Generated Index (PGI). The domains identified with the PGI were then classified and grouped together using the World Health Organization’s International Classification of Functioning, Disability and Health (ICF), and mapped onto the HUI2, HUI3, EQ-5D and SF-6D. Results A total of 185 persons with MS were interviewed on the PGI. The sample was relatively young (mean age 43) and predominantly female. Both men and women had mild disability with a median Expanded Disability Status Scale (EDSS) score of 2. The top 10 domains that patients identified to be the most affected by their MS were, work (62%), fatigue (48%), sports (39%), social life (28%), relationships (23%), walking/mobility (22%), cognition (21%), balance (14%), housework (12%) and mood (11%). The SF-6D included the most number of domains (6 domains) important to people with MS, followed by the EQ-5D (4 domains) and the HUI2 (4 domains) and then the HUI3 (3 domains). The mean and standard deviation (SD) for the PGI, EQ-5D and the SF-6D were 0.50 (SD 0.25), 0.69 (0.18) and 0.69 (0.13), respectively. The magnitude of difference between the PGI and the generic utility measures was large and statistically significant. Conclusion Although the generic utility measures included certain items that were important to people with MS, there were several that were missing. An important consequence of this mismatch was that values of QOL derived from the PGI were importantly and significantly lower than those estimated using any of the generic utility measures. This could have a substantial impact in evaluating the effect of interventions for people with MS. PMID:23618072

Clinical Outcomes of Plavix and Generic Clopidogrel for Patients Hospitalized With an Acute Coronary Syndrome.

PubMed

Ko, Dennis T; Krumholz, Harlan M; Tu, Jack V; Austin, Peter C; Stukel, Therese A; Koh, Maria; Chong, Alice; de Melo, Jose Francisco; Jackevicius, Cynthia A

2018-03-01

Clopidogrel is one of the most commonly prescribed medications because of its ability to improve clinical outcomes for a broad range of cardiovascular conditions. After patent protection expired for Plavix in 2012, many healthcare systems adopted generic clopidogrel as a strategy to reduce healthcare costs. We conducted a population-based observational study to determine whether generic clopidogrel was noninferior to Plavix. Patients who were hospitalized with an acute coronary syndrome (ACS) from 2009 to 2014 in Ontario, Canada, >65 years, survived ≥7 days after discharge, were eligible for inclusion. The primary outcome was a composite of death and recurrent ACS at 1 year. The noninferiority margin was prespecified at a relative hazard difference of 10%. Inverse propensity of treatment weighting of the propensity score was used to account for differences in baseline characteristics between the treatment groups. The effect of clopidogrel on the hazard of clinical outcomes was estimated using a Cox proportional hazards model within the propensity-weighted cohort using Plavix as a reference. Our study included 24 530 patients with ACS, 12 643 were prescribed Plavix and 11  887 were prescribed generic clopidogrel at hospital discharge. The mean age was 77 years, 57% were men, and 21% had an ST-segment-elevation myocardial infarction. At 1 year, 17.6% of patients prescribed Plavix and 17.9% of patients prescribed clopidogrel experienced the primary outcome (hazard ratio, 1.02; 95% confidence interval, 0.96-1.08; P =0.005 for noninferiority). No significant differences between rates of death, all-cause readmission, ACS, stroke or transient ischemic attack, or bleeding were observed. Generic clopidogrel was noninferior to Plavix with respect to the composite end point of death and recurrent hospitalization for ACS at 1 year among adults >65 years after an ACS hospitalization. Our findings support generic clopidogrel in ACS, which could lead to substantial healthcare cost savings. © 2018 American Heart Association, Inc.

Perception of Generic Prescription Drugs and Utilization of Generic Drug Discount Programs

PubMed Central

Omojasola, Anthony; Hernandez, Mike; Sansgiry, Sujit; Jones, Lovell

2012-01-01

Objective Our study aimed to assess patient’s perceptions of generic drugs and utilization of generic drug discount programs. Design, Setting and Participants A survey was administered to adult participants at community health centers and community-based organizations in Houston, Texas, USA (n=525). Main Outcome Measures Multivariate logistic regression was used to quantify the strength of association between generic drug perception and utilization of generic drug discount programs. Results Respondents who agreed that “Generic prescription drugs are as effective as brand name prescription drugs,” were 3 times as likely to utilize generic drug discount programs (AOR: 3.0, 95% CI: 1.8–4.8, P<.001). Compared to non-Hispanic Whites, African Americans (OR: 10.2; 95% CI: 1.4–76.4) and Hispanics (OR: 10.3; 95% CI: 1.3–79.4) were 10 times as likely to agree that generic drugs have more side effects than brand name drugs. Conclusion Race/ethnicity had no impact in utilization of generic drug discount programs, despite racial disparities in perception toward generic drugs’ side effects and generic drugs being inferior to brand name drugs. PMID:23140080

75 FR 66398 - Notice of Availability of the Draft Supplement 45 to the Generic Environmental Impact Statement...

Federal Register 2010, 2011, 2012, 2013, 2014

2010-10-28

... NUCLEAR REGULATORY COMMISSION [Docket Nos. 50-272, 50-311, and 50-354; NRC-2009-0390 and NRC-2009- 0391] Notice of Availability of the Draft Supplement 45 to the Generic Environmental Impact Statement for License Renewal of Nuclear Plants, and Public Meetings for the License Renewal of Hope Creek Generating Station and Salem Nuclear Generating...

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

Towards the system-wide implementation of the International Classification of Functioning, Disability and Health in routine practice: Lessons from a pilot study in China.

PubMed

Li, Jianan; Prodinger, Birgit; Reinhardt, Jan D; Stucki, Gerold

2016-06-13

In 2011 the Chinese leadership in rehabilitation, in collaboration with the International Classification of Functioning, Disability and Health (ICF) Research Branch, embarked on an effort towards the system-wide implementation of the ICF in the healthcare system in China. We report here on the lessons learned from the pilot phase of testing the ICF Generic Set, a parsimonious set of 7 ICF categories, which have been shown to best describe functioning across the general population and people with various health conditions, for use in routine clinical practice in China. The paper discusses whether classification and measurement are compatible, what number of ICF categories should be included in data collection in routine practice, and the usefulness of a functioning profile and functioning score in clinical practice and health research planning. In addition, the paper reflects on the use of ICF qualifiers in a rating scale and the particularities of certain ICF categories contained in the ICF Generic Set when used as items in the context of Chinese rehabilitation and healthcare. Finally, the steps required to enhance the utility of system-wide implementation of the ICF in rehabilitation and healthcare services are set out.

[Biosimilars and medico-economic aspects].

PubMed

Borget, I; Grivel, T

2010-05-01

Although few molecules are available, annual total sales of biotechnology drugs amounted 71 billion $ in 2008) and knew a 17% progression per year. As traditional drugs had their generic, many biotechnology drugs had or will lose their patent and be copied, called "biosimilars" or "follows-on". According to the economic impact of biotechnology drugs, the availability of biosimilars may result in great reduction of drugs expenditure. In 2004, EMEA has set up specific rules for biosimilars, distinct from those applied to generic drugs, based on clinical research requirement and post-authorization follow-up of these drugs, and then significantly impacting on their costs of research, development and marketing. The economy generated by the availability of biosimilars should be lower than expected, even null, contrasting with those usually generated by generics. In order to better understand the medico-economic factors related to biosimilars availability, this article will described the market of the biotechnology drugs. The differences existing between generics and biosimilars and their impact on costs will be presented. Finally, it will focus on the factors that may facilitate or limit the biosimilars development and their substitution.

PedsQL Neurofibromatosis Type 1 Module for children, adolescents and young adults: feasibility, reliability, and validity.

PubMed

Nutakki, Kavitha; Varni, James W; Swigonski, Nancy L

2018-04-01

The objective of the present study was to report on the measurement properties of the Pediatric Quality of Life Inventory (PedsQL) Neurofibromatosis Type 1 Module for pediatric patients ages 5-25 from the perspectives of patients and parents. The 104-item PedsQL NF1 Module and 23-item PedsQL Generic Core Scales were completed in a multi-site national study by 323 patients and 335 parents (343 families). Patients were diagnosed with NF1 using the National Institutes of Health diagnostic criteria. In addition to a Total Scale Score, 18 unidimensional scales were derived measuring skin itch bother, skin sensations, pain, pain impact, pain management, cognitive functioning, speech, fine motor, balance, vision, perceived physical appearance, communication, worry, treatment anxiety, medicines, stomach discomfort, constipation, and diarrhea. The PedsQL NF1 Module Scales evidenced excellent feasibility, excellent reliability for the Total Scale Scores (patient self-report α = 0.98; parent proxy-report α = 0.98), and good to excellent reliability for the 18 individual scales (patient self-report α = 0.71-0.96; parent proxy-report α = 0.73-0.98). Intercorrelations with the Generic Core Scales supported construct validity. Factor analysis supported the unidimensionality of the 18 individual scales. The PedsQL NF1 Module Scales demonstrated acceptable to excellent measurement properties, and may be utilized as standardized metrics to assess NF1-specific symptoms and problems in clinical research and practice in children, adolescents, and young adults.

Validation of Persian Version of PedsQL™ 4.0™ Generic Core Scales in Toddlers and Children

PubMed Central

Gheissari, Alaleh; Farajzadegan, Ziba; Heidary, Maryam; Salehi, Fatemeh; Masaeli, Ali; Mazrooei, Amin; Varni, James W; Fallah, Zahra; Zandieh, Fariborz

2012-01-01

Introduction: To evaluate the reliability, validity and feasibility of the Persian version of the Pediatric Quality of Life inventory (PedsQL™ 4.0™ 4.0) Generic Core Scales in Iranian healthy students ages 7-15 and chronically ill children ages 2-18. Methods: We followed the translation methodology proposed by developer to validate Persian version of PedsQL™ 4.0™ 4.0 Generic Core Scales for children. Six hundred and sixty children and adolescents and their parents were enrolled. Sample of 160 healthy students were chosen by random cluster method between 4 regions of Isfahan education offices and 60 chronically ill children were recruited from St. Alzahra hospital private clinics. The questionnaires were fulfilled by the participants. Results: The Persian version of PedsQL™ 4.0™ 4.0 Generic Core Scales discriminated between healthy and chronically ill children (healthy students mean score was 12.3 better than chronically ill children, P<0.001). Cronbachs’ alpha internal consistency values exceeded 0.7 for children self reports and proxy reports of children 5-7 years old and 13-18 years old. Reliability of proxy reports for 2-4 years old was much lower than 0.7. Although, proxy reports for chronically ill children 8-12 years old was more than 0.7, these reports for healthy children with same age group was slightly lower than 0.7. Constructive, criterion face and content validity were acceptable. In addition, the Persian version of PedsQL™ 4.0™ 4.0 Generic Core Scales was feasible and easy to complete. Conclusion: Results showed that Persian version of PedsQL™ 4.0™ 4.0 Generic Core Scales is valid and acceptable for pediatric health researches. It is necessary to alternate scoring for 2-4 years old questionnaire and to find a way to increase reliability for healthy children aged 8-12 years especially, according to Iranian culture. PMID:22701775

Generic particulate-monitoring system for retrofit to Hanford exhaust stacks

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

Camman, J.W.; Carbaugh, E.H.

1982-11-01

Evaluations of 72 sampling and monitoring systems were performed at Hanford as the initial phase of a program to upgrade such systems. Each evaluation included determination of theoretical sampling efficiencies for particle sizes ranging from 0.5 to 10 micrometers aerodynamic equivalent diameter, addressing anisokinetic bias, sample transport line losses, and collector device efficiency. Upgrades needed to meet current Department of Energy guidance for effluent sampling and monitoring were identified, and a cost for each upgrade was estimated. A relative priority for each system's upgrade was then established based on evaluation results, current operational status, and future plans for the facilitymore » being exhausted. Common system upgrade requirements lead to the development of a generic design for common components of an exhaust stack sampling and monitoring system for airborne radioactive particulates. The generic design consists of commercially available off-the-shelf components to the extent practical and will simplify future stack sampling and monitoring system design, fabrication, and installation efforts. Evaluation results and their significance to system upgrades are empasized. A brief discussion of the analytical models used and experience to date with the upgrade program is included. Development of the generic stack sampling and monitoring system design is outlined. Generic system design features and limitations are presented. Requirements for generic system retrofitting to existing exhaust stacks are defined and benefits derived from generic system application are discussed.« less

Source Data Impacts on Epistemic Uncertainty for Launch Vehicle Fault Tree Models

NASA Technical Reports Server (NTRS)

Al Hassan, Mohammad; Novack, Steven; Ring, Robert

2016-01-01

Launch vehicle systems are designed and developed using both heritage and new hardware. Design modifications to the heritage hardware to fit new functional system requirements can impact the applicability of heritage reliability data. Risk estimates for newly designed systems must be developed from generic data sources such as commercially available reliability databases using reliability prediction methodologies, such as those addressed in MIL-HDBK-217F. Failure estimates must be converted from the generic environment to the specific operating environment of the system in which it is used. In addition, some qualification of applicability for the data source to the current system should be made. Characterizing data applicability under these circumstances is crucial to developing model estimations that support confident decisions on design changes and trade studies. This paper will demonstrate a data-source applicability classification method for suggesting epistemic component uncertainty to a target vehicle based on the source and operating environment of the originating data. The source applicability is determined using heuristic guidelines while translation of operating environments is accomplished by applying statistical methods to MIL-HDK-217F tables. The paper will provide one example for assigning environmental factors uncertainty when translating between operating environments for the microelectronic part-type components. The heuristic guidelines will be followed by uncertainty-importance routines to assess the need for more applicable data to reduce model uncertainty.

Influence of generic reference pricing on medicine cost in Slovenia: a retrospective study

PubMed Central

Marđetko, Nika; Kos, Mitja

2018-01-01

Aim To assess the impact of the generic reference pricing (GRP) system on the prices and cost of medicines in Slovenia approximately 8 years after its introduction in 2003 and before the implementation of the therapeutic reference pricing system. Methods A retrospective study of all medicines (N = 789) included in the GRP system on January 31, 2012 was performed. Medicine prices and cost were analyzed between January 31, 2012 and December 31, 2013 after every update (N = 11) of the maximum reimbursable price (MRP) and were compared to the price and cost on January 31, 2012 (index date). Time trends of different types of medicine prices (maximum allowed price, MRP, and actual wholesale price) were graphically analyzed, and actual wholesale price adjustments to the MRP changes and the budget impact of the GRP were assessed. Results In the 2-year study period, the long-term performance of the GRP system was associated with an approximate 45% decrease in the average MRP or an approximate 20% cost reduction. For each MRP update period, the GRP reduced the cost based on the maximum allowed price for approximately 30%. The wholesale price adjustments were mostly made for medicines priced above the MRP and reduced patients’ out-of-pocket cost. Conclusions In the long term, the GRP system effectively reduced medicine prices and the cost of reimbursed products. PMID:29740992

The impacts of the rise of Paragraph IV challenges on startup alliance formation and firm value in the pharmaceutical industry.

PubMed

Filson, Darren; Oweis, Ahmed

2010-07-01

Court decisions in 1998 encouraged generic producers to pursue Paragraph IV patent challenges. A follow-up decision in 2000 marked the first successful challenge involving a blockbuster and brought further attention to this pathway for generic entry. We consider the impacts of these decisions on R&D-based startups, and we focus on the propensity to form alliances as a primary channel of impact. We find substantial negative impacts on alliance formation and firm value, and only the first event's impacts are restricted to small molecules. The results suggest that policy analyses in settings with R&D-based startups should consider impacts on alliance formation.

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

Impact of brand-name drug worship and expectation psychology on antidepressant efficacy.

PubMed

Cai, Jian; Ye, Meirong; Fei, Chunhua; Xu, Feng

2013-01-01

The choice of the generic drug is reasonable if there is evidence for its therapeutic equivalence with the brand-name drug. However, the reduced effectiveness of switching from brand-name drug to generic drug is not rare. The impact of brand-name worship and expectation psychology on drug efficacy is noteworthy to report. A 45-year-old woman suffered from depression mood disorder. She experienced profound improvement in her depressive symptoms after a switch from domestic generic venlafaxine to imported brand-name counterpart. The interview showed that the woman has a strong brand-name drug worship and expectation psychology, which is representative, typical and popular in China especially in vast rural areas. Medication education does not work too much. The brand-name drug worship and expectation psychology might improve drug efficacy when patient is switched from generic drug to branded medication.

Space Generic Open Avionics Architecture (SGOAA) standard specification

NASA Technical Reports Server (NTRS)

Wray, Richard B.; Stovall, John R.

1994-01-01

This standard establishes the Space Generic Open Avionics Architecture (SGOAA). The SGOAA includes a generic functional model, processing structural model, and an architecture interface model. This standard defines the requirements for applying these models to the development of spacecraft core avionics systems. The purpose of this standard is to provide an umbrella set of requirements for applying the generic architecture models to the design of a specific avionics hardware/software processing system. This standard defines a generic set of system interface points to facilitate identification of critical services and interfaces. It establishes the requirement for applying appropriate low level detailed implementation standards to those interfaces points. The generic core avionics functions and processing structural models provided herein are robustly tailorable to specific system applications and provide a platform upon which the interface model is to be applied.

Worldsid Assessment of Far Side Impact Countermeasures

PubMed Central

Pintar, Frank A.; Yoganandan, Narayan; Stemper, Brian D.; Bostrom, Ola; Rouhana, Stephen W.; Smith, Stuart; Sparke, Laurie; Fildes, Brian N.; Digges, Kennerly H.

2006-01-01

Far side impact trauma has been demonstrated as a significant portion of the total trauma in side impacts. The objective of the study was to assess the potential usefulness of countermeasures and assess the trade-offs associated with generic countermeasure design. Because the WorldSID dummy has demonstrated promise as a potential far side impact dummy, it was chosen to assess countermeasures in this mode. A unique far side impact buck was designed for a sled test system that included, as a standard configuration, a center console and outboard three-point belt system. This configuration assumed a left side driver with a right side impact. The buck allowed for additional options of generic restraints including shoulder or thorax plates or an inboard shoulder belt. The entire buck could be mounted on the sled in either a 90-degree (3-o’clock PDOF) or a 60-degree (2-o’clock PDOF) orientation. A total of 19 WorldSID tests were completed. The inboard shoulder belt configuration produced high shear forces in the lower neck (2430 N) when the belt position was placed over the mid portion of the neck. Shear forces were reduced and of opposite sign when the inboard belt position was horizontal and over the shoulder; forces were similar to the standard outboard belt configuration (830 – 1100 N). A shoulder or thorax restraint was effective in limiting the head excursion, but each caused significant displacement at the corresponding region on the dummy. A shoulder restraint resulted in shoulder displacements of 30 – 43 mm. A thorax restraint caused thorax deflections of 39 – 64 mm. Inboard restraints for far side impacts can be effective in reducing head excursion but the specific design and placement of these restraints determine their overall injury mitigating characteristics. PMID:16968638

The Clinical and Economic Impact of Generic Locking Plate Utilization at a Level II Trauma Center.

PubMed

Mcphillamy, Austin; Gurnea, Taylor P; Moody, Alastair E; Kurnik, Christopher G; Lu, Minggen

2016-12-01

In today's climate of cost containment and fiscal responsibility, generic implant alternatives represent an interesting area of untapped resources. As patents have expired on many commonly used trauma implants, generic alternatives have recently become available from a variety of sources. The purpose of this study was to examine the clinical and economic impact of a cost containment program using high quality, generic orthopaedic locking plates. The implants available for study were anatomically precontoured plates for the clavicle, proximal humerus, distal radius, proximal tibia, distal tibia, and distal fibula. Retrospective review. Level II Trauma center. 828 adult patients with operatively managed clavicle, proximal humerus, distal radius, proximal tibia, tibial pilon, and ankle fractures. Operative treatment with conventional or generic implants. The 414 patients treated with generic implants were compared with 414 patients treated with conventional implants. There were no significant differences in age, sex, presence of diabetes, smoking history or fracture type between the generic and conventional groups. No difference in operative time, estimated blood loss or intraoperative complication rate was observed. No increase in postoperative infection rate, hardware failure, hardware loosening, malunion, nonunion or need for hardware removal was noted. Overall, our hospital realized a 56% reduction in implant costs, an average savings of $1197 per case, and a total savings of $458,080 for the study period. Use of generic orthopaedic implants has been successful at our institution, providing equivalent clinical outcomes while significantly reducing implant expenditures. Based on our data, the use of generic implants has the potential to markedly reduce operative costs as long as quality products are used. Therapeutic Level III.

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.

[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.

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.

Do users of risperidone who switch brands because of generic reference pricing fare better or worse than non-switchers? A New Zealand natural experiment.

PubMed

Lessing, Charon; Ashton, Toni; Davis, Peter

2015-11-01

This study evaluated patient health outcomes and any impact on healthcare costs consequent to the implementation of generic reference-pricing of risperidone in New Zealand using national datasets. Reference pricing risperidone reduced the price of the originator brand by 50 % as well as overall expenditure on risperidone tablets. Half of all patients made a single switch to generic risperidone, with the remainder making multiple switches between brands. 1.5 % made a switch-back to the originator brand. No difference was found in use of healthcare services between switchers and non-switchers of the originator brand or versus the comparator group. This refutes the available literature on brand-to-generic and generic-to-generic switching.

The Impact of Stress Urinary Incontinence on Individual Components of Quality of Life in Malaysian Women.

PubMed

Lim, Renly; Liong, Men Long; Leong, Wing Seng; Lau, Yong Khee; Khan, Nurzalina Abdul Karim; Yuen, Kah Hay

2018-02-01

To assess the impact of stress urinary incontinence (SUI) on individual components of quality of life (QoL) using both condition-specific and generic questionnaires, and to compare the results of the 2 instruments with a control group. Women with or without SUI aged ≥21 years old were recruited. Subjects completed the International Consultation of Incontinence-Urinary Incontinence Short Form (ICIQ-UI-SF), International Consultation of Incontinence-Lower Urinary Tract Symptoms Quality of Life (ICIQ-LUTSqol), and EQ-5D questionnaires. A total of 120 women with SUI and 145 controls participated. The ICIQ-LUTSqol total score (mean ± standard deviation) was significantly higher in the SUI group (38.96 ± 10.28) compared with the control group (20.78 ± 2.73) (P <.001). When adjusted for significant confounders, the SUI group continued to have significantly poorer QoL compared with the control group (P <.001). The negative effect of SUI on "physical activities" and "jobs" were the 2 most frequently reported and burdensome components of the ICIQ-LUTSqol, with approximately 50% of women with SUI affected "moderately" or "a lot." When measured using the EQ-5D questionnaire, there were significantly higher percentages of patients with SUI who had problems with usual activities, pain or discomfort, and anxiety or depression (P <.05). Women suffering from SUI have significantly poorer QoL compared with continent women when measured using both condition-specific and generic QoL measures. Clinicians should pay closer attention to the impact of SUI on individual components of QoL, particularly limitations on physical activities and jobs, which were the 2 most impairing and frequently reported components of QoL. Copyright © 2017 Elsevier Inc. All rights reserved.

Greek Physicians' Perceptions on Generic Drugs in the Era of Austerity

PubMed Central

Labiris, Georgios; Fanariotis, Michael; Kastanioti, Catherine; Alexias, Georgios; Protopapas, Adonis; Karampitsakos, Theodoros; Niakas, Dimitris

2015-01-01

Purpose. To assess the beliefs and preferences of Greek physicians, regarding generic drugs, in the years of financial crisis. Setting. Multicentered, nationwide survey. Material and Methods. A custom questionnaire based on former similar studies was developed and administered to Greek physicians. The variable “perception on generics” was constructed after an exploratory study and the instrument was validated by conventional and Rasch analysis methods. 22 items formed 5 subscales that constructed the variable in question. Results. 908 physicians successfully participated in the study (response rate: 80%). Mean total scores to the instrument were 60.63 ± 12.12 for men and significantly less (58.24 ± 11.73) for women (p = 0.04). Greek physicians were not persuaded on the potential economic gain (45.79 ± 10.53); moreover they identified that Greek authorities cannot address the increased pharmacovigilance mandates. Physicians working in Athens and those working in surgical units demonstrated significantly worse scores than their colleagues from the rest of Greece and those working in Internal Medicine wards (p = 0.03).  Conclusion. Our results suggest an overall poor acceptance of the national initiative on generic drugs by Greek physicians. This trial is registered with Clinicaltrials.gov identifier: NCT01855802. PMID:26457225

A generic bio-economic farm model for environmental and economic assessment of agricultural systems.

PubMed

Janssen, Sander; Louhichi, Kamel; Kanellopoulos, Argyris; Zander, Peter; Flichman, Guillermo; Hengsdijk, Huib; Meuter, Eelco; Andersen, Erling; Belhouchette, Hatem; Blanco, Maria; Borkowski, Nina; Heckelei, Thomas; Hecker, Martin; Li, Hongtao; Oude Lansink, Alfons; Stokstad, Grete; Thorne, Peter; van Keulen, Herman; van Ittersum, Martin K

2010-12-01

Bio-economic farm models are tools to evaluate ex-post or to assess ex-ante the impact of policy and technology change on agriculture, economics and environment. Recently, various BEFMs have been developed, often for one purpose or location, but hardly any of these models are re-used later for other purposes or locations. The Farm System Simulator (FSSIM) provides a generic framework enabling the application of BEFMs under various situations and for different purposes (generating supply response functions and detailed regional or farm type assessments). FSSIM is set up as a component-based framework with components representing farmer objectives, risk, calibration, policies, current activities, alternative activities and different types of activities (e.g., annual and perennial cropping and livestock). The generic nature of FSSIM is evaluated using five criteria by examining its applications. FSSIM has been applied for different climate zones and soil types (criterion 1) and to a range of different farm types (criterion 2) with different specializations, intensities and sizes. In most applications FSSIM has been used to assess the effects of policy changes and in two applications to assess the impact of technological innovations (criterion 3). In the various applications, different data sources, level of detail (e.g., criterion 4) and model configurations have been used. FSSIM has been linked to an economic and several biophysical models (criterion 5). The model is available for applications to other conditions and research issues, and it is open to be further tested and to be extended with new components, indicators or linkages to other models.

A Generic Bio-Economic Farm Model for Environmental and Economic Assessment of Agricultural Systems

PubMed Central

Louhichi, Kamel; Kanellopoulos, Argyris; Zander, Peter; Flichman, Guillermo; Hengsdijk, Huib; Meuter, Eelco; Andersen, Erling; Belhouchette, Hatem; Blanco, Maria; Borkowski, Nina; Heckelei, Thomas; Hecker, Martin; Li, Hongtao; Oude Lansink, Alfons; Stokstad, Grete; Thorne, Peter; van Keulen, Herman; van Ittersum, Martin K.

2010-01-01

Bio-economic farm models are tools to evaluate ex-post or to assess ex-ante the impact of policy and technology change on agriculture, economics and environment. Recently, various BEFMs have been developed, often for one purpose or location, but hardly any of these models are re-used later for other purposes or locations. The Farm System Simulator (FSSIM) provides a generic framework enabling the application of BEFMs under various situations and for different purposes (generating supply response functions and detailed regional or farm type assessments). FSSIM is set up as a component-based framework with components representing farmer objectives, risk, calibration, policies, current activities, alternative activities and different types of activities (e.g., annual and perennial cropping and livestock). The generic nature of FSSIM is evaluated using five criteria by examining its applications. FSSIM has been applied for different climate zones and soil types (criterion 1) and to a range of different farm types (criterion 2) with different specializations, intensities and sizes. In most applications FSSIM has been used to assess the effects of policy changes and in two applications to assess the impact of technological innovations (criterion 3). In the various applications, different data sources, level of detail (e.g., criterion 4) and model configurations have been used. FSSIM has been linked to an economic and several biophysical models (criterion 5). The model is available for applications to other conditions and research issues, and it is open to be further tested and to be extended with new components, indicators or linkages to other models. PMID:21113782

Space Generic Open Avionics Architecture (SGOAA) standard specification

NASA Technical Reports Server (NTRS)

Wray, Richard B.; Stovall, John R.

1993-01-01

The purpose of this standard is to provide an umbrella set of requirements for applying the generic architecture interface model to the design of a specific avionics hardware/software system. This standard defines a generic set of system interface points to facilitate identification of critical interfaces and establishes the requirements for applying appropriate low level detailed implementation standards to those interface points. The generic core avionics system and processing architecture models provided herein are robustly tailorable to specific system applications and provide a platform upon which the interface model is to be applied.

A Systematic Review of Physicians' and Pharmacists' Perspectives on Generic Drug Use: What are the Global Challenges?

PubMed

Toverud, Else-Lydia; Hartmann, Katrin; Håkonsen, Helle

2015-08-01

Generic substitution has been introduced in most countries in order to reduce costs and improve access to drugs. However, regulations and the generic drugs available vary between countries. It is the prescriber or dispenser of the drug who is the final decision maker. Nevertheless, physicians' and pharmacists' perceptions of generic drug use are not well documented to date. This study presents a systematic review of physicians' and pharmacists' perspectives on generic drug use worldwide. A systematic literature search was performed to retrieve all articles published between 2002 and 2012 regarding physicians' and/or pharmacists' experiences with generic drugs and generic substitution. Of 1322 publications initially identified, 24 were eligible for inclusion. Overall, the studies revealed that physicians and pharmacists were aware of the cost-saving function of generic drugs and their role in improving global access to drugs. Nevertheless, marked differences were observed between countries when studying physicians' and pharmacists' perceptions of the available generic drugs. In less mature healthcare systems, large variations regarding, for example, control routines, bioequivalence requirements, and manufacturer standards were reported. A lack of reliable information and mistrust in the efficacy and quality were also mentioned by these participants. In the most developed healthcare systems, the participants trusted the quality of the generic drugs and did not hesitate to offer them to all patients regardless of socioeconomic status. In general, pharmacists seemed to have better knowledge of the concept of bioequivalence and generic drug aspects than physicians. The present study indicates that physicians and pharmacists are aware of the role of generic drugs in the improvement of global access to drugs. However, there are marked differences regarding how these health professionals view the quality of generic drugs depending on the maturity of their country's healthcare system. This can be attributed to the fact that developed healthcare systems have more reliable public control routines for drugs in general as well as better bioequivalence requirements concerning generics in particular.

Preoperative symptoms of body dysmorphic disorder determine postoperative satisfaction and quality of life in aesthetic rhinoplasty.

PubMed

Picavet, Valerie A; Gabriëls, Loes; Grietens, Jente; Jorissen, Mark; Prokopakis, Emmanuel P; Hellings, Peter W

2013-04-01

In patients seeking aesthetic rhinoplasty, a high prevalence of body dysmorphic disorder symptoms has recently been reported. However, the impact of these symptoms on the outcomes after rhinoplasty remains elusive. This large-scale study determines the influence of preoperative body dysmorphic disorder symptoms on patients' postoperative satisfaction and quality of life, using validated questionnaires. A 1-year prospective study of 166 adult patients undergoing cosmetic rhinoplasty in a tertiary referral center was performed. Severity of body dysmorphic disorder symptoms was assessed by the modified Yale-Brown Obsessive Compulsive Scale. Postoperative satisfaction was evaluated using a visual analog scale for patients' appraisal of nasal shape and the Rhinoplasty Outcome Evaluation. Generic quality of life was quantified by the Sheehan Disability Scale, whereas the appearance-related disruption of everyday life was measured by the Derriford Appearance Scale-59. Preoperative body dysmorphic disorder symptom scores inversely correlated with postoperative satisfaction at 3 months (visual analog scale nasal shape: rho = -0.43, p < 0.001; Rhinoplasty Outcome Evaluation: rho = -0.48, p < 0.001) and 12 months (rho = -0.40, p < 0.001; and rho = -0.41, p < 0.001, respectively) after surgery. In addition, body dysmorphic disorder symptom scores positively correlated with Sheehan Disability Scale scores and Derriford Appearance Scale-59 scores at 3 months (rho = 0.43, p < 0.001 and rho = 0.48, p < 0.001, respectively) and 12 months (rho = 0.32, p < 0.001, and rho = 0.48, p < 0.001, respectively) postoperatively. This study provides the first evidence of the negative impact of preoperative body dysmorphic disorder symptoms on subjective outcomes after rhinoplasty, hence unveiling a crucial factor in patient dissatisfaction after aesthetic rhinoplasty.

Might generic OCs create contraceptive price war?

PubMed

1987-02-01

Genora 1/35 and 1/50, the 1st generic oral contraceptives (OCs) in the world, are now being marketed in the US. Clinicians interviewed by "Contraceptive Technology Update" (CTU) offer differing opinions as to what this new OC may mean in the marketplace. Products of Rugby Laboratories, the pills are copy products of Ortho Pharmaceutical's ON 1/35 and ON 1/50 formulations. Most clinicians believe that Genora's success or failure in the OC market depends on its eventual retail price. The price difference of $3-$4 may be sufficiently substantial for retailers to charge less for the generic OCs. If that is the case, many doctors may prescribe a pill which will save their patients $4/month. Dr. Mildred Hanson, a Minneapolis gynecologist/obstetrician, feels any cost savings from Genora will have a significant impact on the OC market. She suggests that the less expensive OCs will catch the attention of health maintenance organizations (HMOs) and the business of women who participate in such health plans. Yet James Burns, director of family planning services for the Hartford City Health Department, thinks that even a full-scale retail price war won't have much effect from a clinic standpoint. He reports that clinics are able to obtain contraceptive supplies rather inexpensively through the contracting system. Hanson also expressed doubt over the potential popularity of Genora 1/50 as clinical concerns about the effects of combined OCs on serum lipid levels and carbohydrate metabolism have resulted in a nationwide push toward OCs containing less than 50 micrograms of estrogen. He indicated concern that declines in pharmaceutical house products from pricing competition with generic pills might have a negative impact on contraceptive research and development. Dick Haskitt, director of business planning for Syntex Laboratories, Inc., who will produce the OCs for Rugby, reports that their market research shows that people are very interested in having a generic OC available. Initially, Genora will be marketed only to retail pharmacies, wholesalers, and drug chains.

The colostomy impact score: development and validation of a patient reported outcome measure for rectal cancer patients with a permanent colostomy. A population-based study.

PubMed

Thyø, A; Emmertsen, K J; Pinkney, T D; Christensen, P; Laurberg, S

2017-01-01

The aim was to develop and validate a simple scoring system evaluating the impact of colostomy dysfunction on quality of life (QOL) in patients with a permanent stoma after rectal cancer treatment. In this population-based study, 610 patients with a permanent colostomy after previous rectal cancer treatment during the period 2001-2007 completed two questionnaires: (i) the basic stoma questionnaire consisting of 22 items about stoma function with one anchor question addressing the overall stoma impact on QOL and (ii) the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ) C30. Answers from half of the cohort were used to develop the score and subsequently validated on the remaining half. Logistic regression analyses identified and selected items for the score and multivariate analysis established the score value allocated to each item. The colostomy impact score includes seven items with a total range from 0 to 38 points. A score of ≥ 10 indicates major colostomy impact (Major CI). The score has a sensitivity of 85.7% for detecting patients with significant stoma impact on QOL. Using the EORTC QLQ scales, patients with Major CI experienced significant impairment in their QOL compared to the Minor CI group. This new scoring system appears valid for the assessment of the impact on QOL from having a permanent colostomy in a Danish rectal cancer population. It requires validation in non-Danish populations prior to its acceptance as a valuable patient-reported outcome measure for patients internationally. Colorectal Disease © 2016 The Association of Coloproctology of Great Britain and Ireland.

Patented drug extension strategies on healthcare spending: a cost-evaluation analysis.

PubMed

Vernaz, Nathalie; Haller, Guy; Girardin, François; Huttner, Benedikt; Combescure, Christophe; Dayer, Pierre; Muscionico, Daniel; Salomon, Jean-Luc; Bonnabry, Pascal

2013-01-01

Drug manufacturers have developed "evergreening" strategies to compete with generic medication after patent termination. These include marketing of slightly modified follow-on drugs. We aimed to estimate the financial impact of these drugs on overall healthcare costs and also to examine the impact of listing these drugs in hospital restrictive drug formularies (RDFs) on the healthcare system as a whole ("spillover effect"). We used hospital and community pharmacy invoice office data in the Swiss canton of Geneva to calculate utilisation of eight follow-on drugs in defined daily doses between 2000 and 2008. "Extra costs" were calculated for three different scenarios assuming replacement with the corresponding generic equivalent for prescriptions of (1) all brand (i.e., initially patented) drugs, (2) all follow-on drugs, or (3) brand and follow-on drugs. To examine the financial spillover effect we calculated a monthly follow-on drug market share in defined daily doses for medications prescribed by hospital physicians but dispensed in community pharmacies, in comparison to drugs prescribed by non-hospital physicians in the community. Estimated "extra costs" over the study period were €15.9 (95% CI 15.5; 16.2) million for scenario 1, €14.4 (95% CI 14.1; 14.7) million for scenario 2, and €30.3 (95% CI 29.8; 30.8) million for scenario 3. The impact of strictly switching all patients using proton-pump inhibitors to esomeprazole at admission resulted in a spillover "extra cost" of €330,300 (95% CI 276,100; 383,800), whereas strictly switching to generic cetirizine resulted in savings of €7,700 (95% CI 4,100; 11,100). Overall we estimated that the RDF resulted in "extra costs" of €503,600 (95% CI 444,500; 563,100). Evergreening strategies have been successful in maintaining market share in Geneva, offsetting competition by generics and cost containment policies. Hospitals may be contributing to increased overall healthcare costs by listing follow-on drugs in their RDF. Therefore, healthcare providers and policy makers should be aware of the impact of evergreening strategies.

Making the Cut in Gifted Selection: Score Combination Rules and Their Impact on Program Diversity

ERIC Educational Resources Information Center

Lakin, Joni M.

2018-01-01

The recommendation of using "multiple measures" is common in policy guidelines for gifted and talented assessment systems. However, the integration of multiple test scores in a system that uses cut-scores requires choosing between different methods of combining quantitative scores. Past research has indicated that OR combination rules…

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

Source Data Applicability Impacts on Epistemic Uncertainty for Launch Vehicle Fault Tree Models

NASA Technical Reports Server (NTRS)

Al Hassan, Mohammad; Novack, Steven D.; Ring, Robert W.

2016-01-01

Launch vehicle systems are designed and developed using both heritage and new hardware. Design modifications to the heritage hardware to fit new functional system requirements can impact the applicability of heritage reliability data. Risk estimates for newly designed systems must be developed from generic data sources such as commercially available reliability databases using reliability prediction methodologies, such as those addressed in MIL-HDBK-217F. Failure estimates must be converted from the generic environment to the specific operating environment of the system where it is used. In addition, some qualification of applicability for the data source to the current system should be made. Characterizing data applicability under these circumstances is crucial to developing model estimations that support confident decisions on design changes and trade studies. This paper will demonstrate a data-source applicability classification method for assigning uncertainty to a target vehicle based on the source and operating environment of the originating data. The source applicability is determined using heuristic guidelines while translation of operating environments is accomplished by applying statistical methods to MIL-HDK-217F tables. The paper will provide a case study example by translating Ground Benign (GB) and Ground Mobile (GM) to the Airborne Uninhabited Fighter (AUF) environment for three electronic components often found in space launch vehicle control systems. The classification method will be followed by uncertainty-importance routines to assess the need to for more applicable data to reduce uncertainty.

An Evaluation of Health Service Impacts Consequent to Switching from Brand to Generic Venlafaxine in New Zealand under Conditions of Price Neutrality.

PubMed

Lessing, Charon; Ashton, Toni; Davis, Peter

2015-07-01

To study the health impact on adult New Zealand patients who switch from originator brand to generic venlafaxine. The national pharmacy database was used to select patients using venlafaxine for at least 6 months. Switchers and nonswitchers were identified, and switch behavior was compared for a 12-month follow-up period. Change in health service use following switching was also compared between switchers and nonswitchers including use of the emergency department, hospital, and specialist outpatient services over the same period. Approximately 12% of all originator brand users switched to generic venlafaxine, at least half of whom continued to use the generic throughout the follow-up period to August 1, 2012. Almost 60% of new users of the generic venlafaxine, however, switched to using the originator brand. Aside from a slight reduction in the use of outpatient services among switchers, there were no significant differences in health services use between switchers and nonswitchers for either existing or new venlafaxine users. Although both products remain fully subsidized and available, there is little incentive for prescribers, pharmacists, or patients to switch to the less expensive generic brand. If savings to the national New Zealand budget are to be realized, additional policy measures should be implemented to minimize incentives for multiple and reverse switching, and prescribers, as key opinion leaders, could take the lead in promoting generics to their patients. Copyright © 2015. Published by Elsevier Inc.

The Impact of Generic Substitution on Health and Economic Outcomes: A Systematic Review.

PubMed

Gothe, H; Schall, I; Saverno, K; Mitrovic, M; Luzak, A; Brixner, D; Siebert, U

2015-08-01

Generic drugs are considered therapeutically equivalent to their original counterparts and lower in acquisition costs. However, the overall impact of generic substitution (GS) on global clinical and economic outcomes has not been conclusively evaluated. To test whether (1) generics and original products yield the same health outcomes, and (2) generic therapies save economic resources versus original therapies. We performed a systematic literature review in Medline, Embase, and the Cochrane Database of Systematic Reviews to identify original studies that examine clinical or economic outcomes of GS. After standardized data extraction, reported outcomes were categorized as supporting or rejecting the hypotheses. Each reported outcome was assessed and accounted for supporting and opposing GS. One publication could provide multiple outcome comparisons. We included 40 studies across ten therapeutic areas. Fourteen studies examined patients on de novo therapy; 24 studies investigated maintenance drug therapy, and two studies considered both settings. Overall, 119 outcome comparisons were examined. Of 97 clinical outcome comparisons, 67% reported no significant difference between generic drugs and their off-patent counterparts. Of 22 economic comparisons, 64% suggested that GS increased costs. Consequently, hypothesis (1) was supported but hypothesis (2) was not. We found no major differences among studies that investigated clinical outcomes with de novo or maintenance therapy. The review suggests that clinical effects are similar after GS. However, economic savings are not guaranteed. More systematic research comparing clinical and economic outcomes with or without GS is needed to inform policy on the use of generic substitution.

Substitution laws, insurance coverage, and generic drug use.

PubMed

Anis, A H

1994-03-01

This study examined the role of various policies (drug product substitution laws) that are usually motivated by cost containment objectives of insurers in facilitating entry by generic firms. Using data for six Canadian provinces over the years 1981-1988, we evaluated the impact of specific aspects of substitution laws on the level of generic use. We find that formularies and the passage of time are not significant determinants of substitution levels. Legal liability, mandatory product selection, deductible and co-payment schemes, and consumer awareness were found to be important variables. Price responsiveness of generic drugs is indicated but the evidence is not strong.

A methodology to assess groundwater risk from hydraulic fracturing and other hydrocarbon activities in 3D

NASA Astrophysics Data System (ADS)

Loveless, S.; Lewis, M.; Bloomfield, J.; Ward, R.; Davey, I.; Hart, A.

2017-12-01

The shale gas boom of the US has prompted a renewed interest in onshore oil and gas in England. Shale gas has received most public attention, but exploration licences have also been granted for coal bed methane and conventional hydrocarbon resources. Hydraulic fracturing, both from vertical and lateral wells, is a significant contributing factor to the recent successes of hydrocarbon activities in the US. However, there are concerns in England regarding potential environmental impacts of subsurface pathways which may connect the hydrocarbon rocks (and injected fluids) with exploitable groundwater. In England groundwater is an important resource, providing 31% (locally up to 100% in the southeast) of water resources. The British Geological Survey has been working with the Environment Agency in England to understand the hazards and risks to overlying groundwater from onshore hydrocarbon exploitation. In the US, contrasting evidence for stray gas migration from shale targets to drinking water shows that differences in geological conditions contribute to a variation in risk between sites. These geological factors include proximity of the hydrocarbon rock to the groundwater receptor, pre-existing geological pathways, low permeability units, and a driving force (e.g. hydraulic head). Due to substantial geological variation across England, a generic approach to risk assessment that can be applied to specific sites has been developed. A methodology has been developed based on DRASTIC principles, whereby a risk score is attributed to formations within a volume of interest, based on a rank and weighting system for each geological factor, multiplied by a hazard score for a given hydrocarbon activity. This score is compared with an assessment of the importance of the receptor. Scores are relative and enable comparison between different activities and sites. Uncertainty is explicitly assessed and factors with a high degree of uncertainty to be systematically identified and addressed. Rankings should be amended as additional data is obtained. Tests on areas identified for potential hydrocarbon exploration in England show that whilst geological scenarios with very high and low risks are theoretically possible, the majority of proposed locations would have similar risks under the current categorisation system.

Delay correlation analysis and representation for vital complaint VHDL models

DOEpatents

Rich, Marvin J.; Misra, Ashutosh

2004-11-09

A method and system unbind a rise/fall tuple of a VHDL generic variable and create rise time and fall time generics of each generic variable that are independent of each other. Then, according to a predetermined correlation policy, the method and system collect delay values in a VHDL standard delay file, sort the delay values, remove duplicate delay values, group the delay values into correlation sets, and output an analysis file. The correlation policy may include collecting all generic variables in a VHDL standard delay file, selecting each generic variable, and performing reductions on the set of delay values associated with each selected generic variable.

The impact of generic reference pricing in Italy, a decade on.

PubMed

Ghislandi, Simone; Armeni, Patrizio; Jommi, Claudio

2013-12-01

The generic reference price (GRP) was introduced in Italy in 2001. The main purpose of this paper is: (a) producing evidence regarding the effect of GRP on prices; (b) testing the hypothesis that there is a reallocation of demand from the genericated (and reference-priced) molecules to patent-protected products that have the same therapeutic indication. The analysis used a unique dataset of quantities and revenues of six therapeutic groups that were observed for more than a decade. Difference-in-differences analysis is applied. Prices are adjusted for all the regulatory interventions in the ten years of observations, to control for confounding impact of these interventions. On average, prices dropped 13% more in groups to which GRP was applied than in other groups. Moreover, each entry of a new generic was associated with a price drop of around 2.8%. On the other hand, GRP did not induce any significant switching towards in-patent molecules. We provide the first empirical results of the impact of GRP on prices in Italy and evidence that GRP cannot be held solely responsible for the often reported demand reallocation towards new and in-patent molecules.

Evaluation of patient characteristics as predictors of health status in knee osteoarthritis patients referred for physical therapy.

PubMed

Gonçalves, Rui Soles; Cabri, Jan; Pinheiro, J P

2011-01-01

The purpose of this cross sectional study was to estimate the contributions of patient characteristics to variation in joint-specific and generic health status in knee osteoarthritis (OA) patients referred for physical therapy. The Portuguese Knee injury and Osteoarthritis Outcome Score (KOOS) and Medical Outcomes Study - 36 item Short Form (SF-36) questionnaires, and a form for the patient characteristics (gender, age, body mass index, profession, professional situation, educational level, marital status, duration of knee OA, involved knee and walking aids) were self-administered to 377 subjects with symptomatic knee OA (282 females, 95 males; age: 67.8 ± 8.2 years). Multiple stepwise regression analyses revealed that patient characteristics explained only 9.4% to 19.7% of the variance in KOOS subscales scores, and only 1.0% to 17.2% of the variance in SF-36 subscales scores. Therefore, it can be concluded that the patient characteristics studied were limited predictors of joint-specific and generic health status in knee OA patients referred for physical therapy.

Impact of cost sharing on prescription drugs used by Medicare beneficiaries.

PubMed

Goedken, Amber M; Urmie, Julie M; Farris, Karen B; Doucette, William R

2010-06-01

Incentive-based prescription drug cost sharing can encourage seniors to use generic medications. Little information exists about prescription drug cost sharing and generic use in employer-sponsored plans after the implementation of Medicare Part D. To compare prescription drug cost sharing across prescription insurance type for Medicare beneficiaries after Medicare Part D, to assess the impact of that cost sharing on the number of medications used, and to examine how generic utilization rates differ before and after Medicare Part D and across the type of insurance. This longitudinal study of Medicare beneficiaries aged 65 years and older used Web-based surveys administered in 2005 and 2007 by Harris Interactive((R)) to collect information on prescription drug coverage and medication use. Co-payment plans were categorized as low, medium, or high co-payment plans. Multiple regression was used to assess the impact of co-payment rank on the number of prescription drugs. t-Tests and analysis of variance were used to compare generic use over time and between coverage types. One thousand two hundred twenty and 1024 respondents completed the baseline and follow-up surveys, respectively. Among 3-tier co-payment plans, brand drug co-payments were higher for Part D plans ($26 for preferred brand and $55 for nonpreferred brand) than employer-based plans ($20 for preferred brand and $39 for nonpreferred brand). Co-payment was not a significant predictor for the number of prescription drugs. Generic use was lowest among beneficiaries in employer plans both before and after Part D. In 2007, generic use among beneficiaries with Part D was not significantly different from the generic use for beneficiaries with no drug coverage. Medicare beneficiaries in Part D had higher cost sharing amounts than those with employer coverage, but higher cost sharing was not significantly linked to lower prescription use. Generic use for Part D beneficiaries was higher than that for beneficiaries with employer coverage but the same as that for beneficiaries without drug coverage. Copyright 2010 Elsevier Inc. All rights reserved.

Prospective study of the impact on quality of life of cystectomy with ileal conduit urinary diversion for neurogenic bladder dysfunction.

PubMed

Guillotreau, Julien; Castel-Lacanal, Evelyne; Roumiguié, Mathieu; Bordier, Benoit; Doumerc, Nicolas; De Boissezon, Xavier; Malavaud, Bernard; Marque, Philippe; Rischmann, Pascal; Gamé, Xavier

2011-11-01

Neurogenic bladder dysfunction has a negative impact on the patient's quality of life (QoL). Cystectomy with ileal conduit urinary diversion is a treatment option in patients in failure after conservative management. The objective of this study was to evaluate the impact of ileal conduit urinary diversion on the QoL of patients with neurogenic bladder dysfunction. From March 2004 to November 2010, 48 patients (36 women and 12 men with a mean age of 50.6  ±  11.8 years) treated by cystectomy with ileal conduit urinary diversion for neurogenic bladder dysfunction, prospectively completed, before and after surgery, two self-administered QoL questionnaires. Neurological diseases were multiple sclerosis in 38 cases, spinal cord injury in 7 cases, and other neurological disease in 3 cases. Cystectomy was performed by laparoscopy in all patients. QoL was measured by using two self-administered questionnaires, one questionnaire specific for urinary disorders validated in neurological patients, Qualiveen®, and the generic SF36-v2® questionnaire. Data were compared by Student's t test. Comparison of the Qualiveen® self-administered questionnaire scores and indices before and after surgery showed that, after surgery, patients presented a significant reduction of limitations (0.57 ± 0.64 vs. 1.55 ± 1.35, P < 0.001), constraints (2.12  ±  0.83 vs. 2.64  ±  1.12, P = 0.046) scores and the SIUP index (1.29 ± 0.65 vs. 1.79 ± 0.95, P = 0.015). No significant change in SF36-v2® scores was observed postoperatively. Ileal conduit urinary diversion improves the urinary QoL of patients with neurogenic bladder dysfunction by decreasing limitations and constraints induced by urinary disorders, but has no impact on general QoL. Copyright © 2011 Wiley Periodicals, Inc.

[Generic drugs in Brazil: impacts of public policies upon the national industry].

PubMed

Quental, Cristiane; de Abreu, Jussanã Cristina; Bomtempo, José Vitor; Gadelha, Carlos Augusto Grabois

2008-04-01

This paper echoes recent works of Abrasco, Gadelha and Guimarães emphasizing the need for a better integration between health policies and industrial development and innovation policies as the only way to keep the economic benefits generated by health expenditures in the country instead of letting them escape through imports and threaten the continuity of the social policy by growing trade deficits. Although presenting the generic drug policy as a successful case in integrating social policies aimed at a better access to quality drugs for the population with economic policies aimed at industrial development, this paper discusses the impacts and limitations of the referred policy in a dialog with Abreu's analysis of industrial competitiveness in the Brazilian generics industry.

The Impact of Misspelled Words on Automated Computer Scoring: A Case Study of Scientific Explanations

ERIC Educational Resources Information Center

Ha, Minsu; Nehm, Ross H.

2016-01-01

Automated computerized scoring systems (ACSSs) are being increasingly used to analyze text in many educational settings. Nevertheless, the impact of misspelled words (MSW) on scoring accuracy remains to be investigated in many domains, particularly jargon-rich disciplines such as the life sciences. Empirical studies confirm that MSW are a…

The Impact of Different Scoring Rubrics for Grading Virtual Patient-Based Exams

ERIC Educational Resources Information Center

Fors, Uno G. H.; Gunning, William T.

2014-01-01

Virtual patient cases (VPs) are used for healthcare education and assessment. Most VP systems track user interactions to be used for assessment. Few studies have investigated how virtual exam cases should be scored and graded. We have applied eight different scoring models on a data set from 154 students. Issues studied included the impact of…

The impact of perceived lack of support provided by health and social care services to caregivers of people with motor neuron disease.

PubMed

Peters, Michele; Fitzpatrick, Ray; Doll, Helen; Playford, E Diane; Jenkinson, Crispin

2012-02-01

Our objective was to investigate the relationship between support by health and social care services and caregiver well-being. A survey, including a generic health status measure (SF-12), a disease-specific measure for patients (ALSAQ-40), the Carer Strain Index (CSI) for caregivers and questions on experiences of health and social care services, was sent to patient members of the MND Association (UK) and their caregivers. A single 'problem score' was calculated from the experience questions and the relationship between the problem score with caregiver and patient well-being was analysed. Most caregivers reported at least one problem with support from services. The most common problems were services not valuing caregivers' experiences, and caregivers not feeling sufficiently involved in planning care. The problem score significantly increased with increasing caregiver strain and worsening mental health. The problem score was also increased as patient well-being decreased. The results suggest that caregiver strain was higher and mental health lower as the number of problems reported increased. A higher perceived lack of caregiver support was also related to a decrease in patient well-being, suggesting that caregivers' needs increase as the disease progresses. This emphasizes the importance of MND caregivers being appropriately supported by health and social care services in their caregiving role.

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.

Impact of Mobility Device Use on Quality of Life in Children With Friedreich Ataxia.

PubMed

Ejaz, Resham; Chen, Shiyi; Isaacs, Charles J; Carnevale, Amanda; Wilson, Judith; George, Kristen; Delatycki, Martin B; Perlman, Susan L; Mathews, Katherine D; Wilmot, George R; Hoyle, J Chad; Subramony, Sub H; Zesiewicz, Theresa; Farmer, Jennifer M; Lynch, David R; Yoon, Grace

2018-05-01

To determine how mobility device use impacts quality of life in children with Friedreich ataxia. Data from 111 pediatric patients with genetically confirmed Friedreich ataxia were collected from a prospective natural history study utilizing standardized clinical evaluations, including health-related quality of life using the Pediatric Quality of Life Inventory (PedsQL) 4.0 Generic Core Module. Mobility device use was associated with worse mean PedsQL total, physical, emotional, social, and academic subscores, after adjusting for gender, age of disease onset, and Friedreich Ataxia Rating Scale score. The magnitude of the difference was greatest for the physical subscore (-19.5 points, 95% CI = -30.00, -8.99, P < .001) and least for the emotional subscore (-10.61 points, 95% CI = -20.21, -1.02, P = .03). Transition to or between mobility devices trended toward worse physical subscore (-16.20 points, 95% CI = -32.07, -0.33, P = .05). Mobility device use is associated with significant worsening of all domains of quality of life in children with Friedreich ataxia.

Potential for erroneous interpretation of poisoning outcomes due to changes in National Poison Data System reporting.

PubMed

Anderson, Bruce; Ke, Xuehua; Klein-Schwartz, Wendy

2010-08-01

In 2006, the annual report of poison centers in the United States changed the method of reporting profiles for generic substance categories from all exposures to single-substance exposures only. The objective of this study is to describe the potential impact of this reporting change on longitudinal analysis of outcomes. Generic substance categories with data available for all years of the study were manually extracted from Table 22 of the National Poison Data System (NPDS) annual reports for 2002-2007. For each generic substance category, the following data were extracted for each of the 6 years: total number of substance mentions (2002-2005) or single-substance exposures (2006-2007), reason (unintentional or intentional), pediatric exposures (children age <6 years), and outcomes of major effect and death. Data were compared using descriptive analysis (Wilcoxon signed-rank test) and negative binomial regression. There were 65 generic substance categories (30 drug categories and 35 nondrug categories) that had data in all study years. For drug categories the average annual number of reported deaths by substance category decreased by 80.8%, from 2,229 in year 2002-2005 to 428 after the 2006 reporting change (p < 0.0001). The average annual number of reported major outcomes by substance category dropped by 76.0% (p < 0.0001). The impact on nondrug categories was similar: the annual average number of deaths and major effects by substance category decreased by about 50% from 394 and 4,639 per year during 2002-2005 to 198 deaths (p < 0.0001) and 2,357 major effects (p ≤ 0.0001) during 2006-2007. After controlling for potential covariates, multivariate regression showed that there were significant decreases in average rates of reported deaths (61.7 and 35.9%) and major effects (36.3 and 11.2%) for drug categories and nondrug categories, respectively (p < 0.01 for all). Overall rates of major outcomes and deaths reported to poison control centers from 2002 to 2007 have remained constant. The new method of describing demographic data in Table 22 results in outcomes that are different from those reported in previous NPDS annual reports. Comparing NPDS generic substance outcome data before and after the reporting change in 2006 will yield inaccurate results if the change in reporting methodology is not taken into account.

Economic Impacts of the Generic Drug User Fee Act Fee Structure.

PubMed

Dong, Ke; Boehm, Garth; Zheng, Qiang

2017-06-01

A Food and Drug Administration (FDA) Generic Drug User system, Generic Drug User Fee Amendment of 2012 (GDUFA), started October 1, 2012, and has been in place for over 3 years. There is controversy about the GDUFA fee structure but no analysis of GDUFA data that we could find. To look at the economic impact of the GDUFA fee structure. We compared the structure of GDUFA with that of other FDA Human Drug User fees. We then, using FDA-published information, analyzed where GDUFA facility and Drug Master File fees are coming from. We used the Orange Book to identify the sponsors of all approved Abbreviated New Drug Applications (ANDAs) and the S&P Capital IQ database to find the ultimate parent companies of sponsors of approved ANDAs. The key differences between the previous structure for Human Drug User fees and the GDUFA are as follows: GDUFA has no approved product fee and no first-time or small business fee exemptions and GDUFA charges facility fees from the time of filing and charges a foreign facility levy. Most GDUFA fees are paid by or on behalf of foreign entities. The top 10 companies hold nearly 50% of all approved ANDAs but pay about 14% of GDUFA facility fees. We conclude that the regressive nature of the GDUFA fee structure penalizes small, new, and foreign firms while benefiting the large established firms. A progressive fee structure in line with other human drug user fees is needed to ensure a healthy generic drug industry. Copyright © 2017 International Society for Pharmacoeconomics and Outcomes Research (ISPOR). Published by Elsevier Inc. All rights reserved.

The impact of different scenarios for intermittent bladder catheterization on health state utilities: results from an internet-based time trade-off survey.

PubMed

Averbeck, Márcio Augusto; Krassioukov, Andrei; Thiruchelvam, Nikesh; Madersbacher, Helmut; Bøgelund, Mette; Igawa, Yasuhiko

2018-06-08

Intermittent catheterization (IC) is the gold standard for bladder management in patients with chronic urinary retention. Despite its medical benefits, IC-users experience a negative impact on their quality of life (QoL). For health economics based decision making, this impact is normally measured using generic QoL measures (such as EQ-5D) that estimate a single utility score which can be used to calculate Quality-Adjusted Life Years (QALYs). But these generic measures may not be sensitive to all relevant aspects of QoL affected by intermittent catheters. This study used alternative methods to estimate the health state utilities associated with different scenarios: using a multiple-use catheter, one-time-use catheter, pre-lubricated one-time-use catheter, and pre-lubricated one-time-use catheter with one less urinary tract infection (UTI) per year. Health state utilities were elicited through an internet-based Time Trade-Off (TTO) survey in adult volunteers representing the general population in Canada and the UK. Health states were developed to represent the catheters based on the following four attributes: steps and time needed for IC process, pain and the frequency of UTIs. The survey was completed by 956 respondents. One-time-use catheters, pre-lubricated one-time-use catheters and ready-to-use catheters were preferred to multiple-use catheters. The utility gains were associated with the following features: one-time-use (Canada: +0.013, UK: +0.021), ready-to-use (all: +0.017), and one less UTI/year (all: +0.011). Internet-based survey responders may have valued health states differently than the rest of the population: this might be a source of bias. Steps and time needed for the IC process, pain related to IC, and the frequency of UTIs have a significant impact on IC related utilities. These values could be incorporated into a cost utility analysis.

Comparison of disease-specific quality of life tools in patients with chronic venous disease.

PubMed

Kuet, Mong-Loon; Lane, Tristan Ra; Anwar, Muzaffar A; Davies, Alun H

2014-12-01

This work was presented as a poster in the American Venous Forum 25th Annual Meeting; 28 February 2013; Phoenix, Arizona, USA. Quality of life (QoL) is an important outcome measure in the treatment for chronic venous disease. The Aberdeen Varicose Vein Questionnaire (AVVQ) and the ChronIc Venous Insufficiency quality of life Questionnaire (CIVIQ-14) are two validated disease-specific QoL questionnaires in current use. The aim of this study is to evaluate the relationship between the AVVQ and the CIVIQ-14 to enable better comparison between studies and to compare these disease-specific QoL tools with generic QoL and clinician-driven tools. Adults attending our institution for management of their varicose veins completed the AVVQ, CIVIQ-14 and EuroQol-5D (EQ-5D). Clinical data, CEAP classification and the Venous Clinical Severity Score (VCSS) were collected. The relationship between the AVVQ and CIVIQ-14 scores was analysed using Spearman's correlation. The AVVQ and CIVIQ-14 scores were also analysed with a generic QoL tool (EQ-5D) and a clinician-driven tool, the VCSS. One hundred patients, mean age 57.5 (44 males; 56 females), participated in the study. The median AVVQ score was 21.9 (range 0-74) and the median CIVIQ-14 score was 30 (range 0-89). A strong correlation was demonstrated between the AVVQ and CIVIQ-14 scores (r = 0.8; p < 0.0001). Strong correlation was maintained for patients with C1-3 disease (r = 0.7; p < 0.0001) and C4-6 disease (r = 0.8; p < 0.0001). The VCSS correlated strongly with the AVVQ and CIVIQ-14 scores (r = 0.7; p < 0.0001 and r = 0.7; p < 0.0001, respectively). Both the AVVQ and CIVIQ-14 scores correlated well with the EQ-5D score (r = -0.5; p < 0.0001 and r = -0.7; p < 0.0001, respectively). This study demonstrates that there is good correlation between two widely used varicose vein specific QoL tools (AVVQ and CIVIQ-14) across the whole spectrum of disease severity. Strong correlation exists between these disease-specific QoL tools and generic and clinician-driven tools. Our findings confirm valid comparisons between studies using either disease-specific QoL tool. © The Author(s) 2013 Reprints and permissions: sagepub.co.uk/journalsPermissions.nav.

[Generic drugs and the consumption trends of antihypertensives in Morocco].

PubMed

Berrada El Azizi, Ghizlane; Ahid, Samir; Ghanname, Imane; Ghannam, Imane; Belaiche, Abdelmajid; Hassar, Mohammed; Cherrah, Yahia

2013-01-01

To evaluate the evolution of consumption of antihypertensive drugs generic among 1991-2010, to assess the impacts after the institution of Mandatory Health Insurance and the marketing of generic drugs. We used sales data from the Moroccan subsidiary of IMS Health Intercontinental Marketing Service. Consumption of generic antihypertensive drugs increased from 0.08 to 10.65 DDD/1 000 inhabitants/day between 1991 and 2010. In 2010, generic of the calcium channel blockers (CCBs) represented 4.08 DDD/1 000 inhabitants/day (82.09%), followed by angiotensin converting enzyme inhibitors (ACEI) by 2.40 DDD/1 000 inhabitants/day (48.29%). The generics market of CCBs is the most dominant and represented in 2010, 79.21% in volume and 62.58% in value. In developing countries like Morocco, the generic drug is a key element for access to treatment especially for the poor population. © 2013 Société Française de Pharmacologie et de Thérapeutique.

The impact of generic reference pricing interventions in the statin market.

PubMed

Puig-Junoy, Jaume

2007-11-01

The objective of this study was to evaluate the intended and unintended impact on pharmaceutical use and sales of three public reimbursement reforms applied to the prescription of statins: a Spanish generic reference pricing system, and two competing policies introduced by the Andalusian Public Health Service. This study is designed as an interrupted time series analysis with comparison series of 46 monthly drug use and sales figures from January 2001 to October 2004 for each active ingredient. The mean monthly saving for the year after the introduction of reference pricing was 16.7% of total lovastatin sales, representing only 1.1% of total statins sales. Mean monthly savings for the 10 months after reference pricing being applied to simvastatin were 51.8% of simvastatin sales, and 13.9% of statin sales. Over the 46 months of the study, all analysed public interventions resulted in a 2.2% average monthly decrease in statin sales in the rest of Spain and savings non-significantly different from zero in Andalusia. RP has been effective at reducing the volume of sales growth of the off-patent statins, yet its overall impact on sales of all statins has been relatively modest.

The DEP-6D, a new preference-based measure to assess health states of dependency.

PubMed

Rodríguez-Míguez, E; Abellán-Perpiñán, J M; Alvarez, X C; González, X M; Sampayo, A R

2016-03-01

In medical literature there are numerous multidimensional scales to measure health states for dependence in activities of daily living. However, these scales are not preference-based and are not able to yield QALYs. On the contrary, the generic preference-based measures are not sensitive enough to measure changes in dependence states. The objective of this paper is to propose a new dependency health state classification system, called DEP-6D, and to estimate its value set in such a way that it can be used in QALY calculations. DEP-6D states are described as a combination of 6 attributes (eat, incontinence, personal care, mobility, housework and cognition problems), with 3-4 levels each. A sample of 312 Spanish citizens was surveyed in 2011 to estimate the DEP-6D preference-scoring algorithm. Each respondent valued six out of the 24 states using time trade-off questions. After excluding those respondents who made two or more inconsistencies (6% out of the sample), each state was valued between 66 and 77 times. The responses present a high internal and external consistency. A random effect model accounting for main effects was the preferred model to estimate the scoring algorithm. The DEP-6D describes, in general, more severe problems than those usually described by means of generic preference-based measures. The minimum score predicted by the DEP-6D algorithm is -0.84, which is considerably lower than the minimum value predicted by the EQ-5D and SF-6D algorithms. The DEP-6D value set is based on community preferences. Therefore it is consistent with the so-called 'societal perspective'. Moreover, DEP-6D preference weights can be used in QALY calculations and cost-utility analysis. Copyright © 2016. Published by Elsevier Ltd.

The effect of generic competition on the price of brand-name drugs.

PubMed

Lexchin, Joel

2004-04-01

Literature from the US has shown that brand-name manufacturers do not compete on price once generic competitors become available. This study was undertaken to investigate if this is also true in Canada. Editions of the Ontario Drug Benefit Formulary were used to identify brand-name drugs that lacked generic competition in July 1990 but had acquired one or more generic competitors by December 1998. Prices of the brand-name drugs were compared before generic competition, at the point when generic competition started and subsequent to the initiation of competition. Price changes for 81 different products in 144 separate presentations were analysed. There was no statistically significant change in brand-name prices when generic competition started. The movement of brand-name prices was not influenced by whether the generic was made by the company producing the brand-name product or price freezes imposed by the Ontario government. When generics first became available having four or more generics was associated with a rise in the price of the brand-name drugs compared to having one, two or three generic competitor(s). The lack of price competition may lead to increased costs in the private market. Private insurance companies generally do not require generic substitution and some provinces do not require generic substitution for cash-paying customers. Maintaining higher prices on brand-name drugs impacts on the prices of new patented medications coming onto the Canadian market under the current pricing guidelines of the Patented Medicine Prices Review Board.

A new instrument for measuring anticoagulation-related quality of life: development and preliminary validation

PubMed Central

Samsa, Greg; Matchar, David B; Dolor, Rowena J; Wiklund, Ingela; Hedner, Ewa; Wygant, Gail; Hauch, Ole; Marple, Cheryl Beadle; Edwards, Roger

2004-01-01

Background Anticoagulation can reduce quality of life, and different models of anticoagulation management might have different impacts on satisfaction with this component of medical care. Yet, to our knowledge, there are no scales measuring quality of life and satisfaction with anticoagulation that can be generalized across different models of anticoagulation management. We describe the development and preliminary validation of such an instrument – the Duke Anticoagulation Satisfaction Scale (DASS). Methods The DASS is a 25-item scale addressing the (a) negative impacts of anticoagulation (limitations, hassles and burdens); and (b) positive impacts of anticoagulation (confidence, reassurance, satisfaction). Each item has 7 possible responses. The DASS was administered to 262 patients currently receiving oral anticoagulation. Scales measuring generic quality of life, satisfaction with medical care, and tendency to provide socially desirable responses were also administered. Statistical analysis included assessment of item variability, internal consistency (Cronbach's alpha), scale structure (factor analysis), and correlations between the DASS and demographic variables, clinical characteristics, and scores on the above scales. A follow-up study of 105 additional patients assessed test-retest reliability. Results 220 subjects answered all items. Ceiling and floor effects were modest, and 25 of the 27 proposed items grouped into 2 factors (positive impacts, negative impacts, this latter factor being potentially subdivided into limitations versus hassles and burdens). Each factor had a high degree of internal consistency (Cronbach's alpha 0.78–0.91). The limitations and hassles factors consistently correlated with the SF-36 scales measuring generic quality of life, while the positive psychological impact scale correlated with age and time on anticoagulation. The intra-class correlation coefficient for test-retest reliability was 0.80. Conclusions The DASS has demonstrated reasonable psychometric properties to date. Further validation is ongoing. To the degree that dissatisfaction with anticoagulation leads to decreased adherence, poorer INR control, and poor clinical outcomes, the DASS has the potential to help identify reasons for dissatisfaction (and positive satisfaction), and thus help to develop interventions to break this cycle. As an instrument designed to be applicable across multiple models of anticoagulation management, the DASS could be crucial in the scientific comparison between those models of care. PMID:15132746

Impacts of regulated competition on pricing in Chinese pharmaceutical market under urban employee basic medical insurance.

PubMed

Zhao, Mingyue; Wu, Jing

2017-06-01

Examine the effects of regulated competition on the drug pricing in China. Based on product-level data, a regression method was employed for pricing by using data from Tianjin Urban Employee Basic Medical Insurance (UEBMI) database. The market competition measures distinguished generic competition within the same molecule from therapeutic competition within the same therapeutic class. The increases in pricing are inversely related to the number of generic competitions. The generic sub-group results vary from the originator sub-group. For the generics, generic competition has a significantly reduced effect on the price; however, only therapeutic competition has a significantly reduced effect on the originator price. Regulated competition has a positive role in shaping the pharmaceutical market. Furthermore, regulated competition affects the price differently for the sub-groups. The promotion of competition between generic and originator in order to reap full competition benefit and reduce frictions among policies are necessary.

The global biopharma industry and the rise of Indian drug multinationals: implications for Australian generics policy.

PubMed

Löfgren, Hans

2007-06-01

This article provides a synopsis of the new dynamics of the global biopharma industry. The emergence of global generics companies with capabilities approximating those of 'big pharma' has accelerated the blurring of boundaries between the innovator and generics sectors. Biotechnology-based products form a large and growing segment of prescription drug markets and regulatory pathways for biogenerics are imminent. Indian biopharma multinationals with large-scale efficient manufacturing plants and growing R&D capabilities are now major suppliers of Active Pharmaceutical Ingredients (APIs) and generic drugs across both developed and developing countries. In response to generic competition, innovator companies employ a range of life cycle management techniques, including the launch of 'authorised generics'. The generics segment in Australia will see high growth rates in coming years but the prospect for local manufacturing is bleak. The availability of cheap generics in international markets has put pressure on Pharmaceutical Benefits Scheme (PBS) pricing arrangements, and a new policy direction was announced in November 2006. Lower generics prices will have a negative impact on some incumbent suppliers but industrial renewal policies for the medicines industry in Australia are better focused on higher value R&D activities and niche manufacturing of sophisticated products.

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.

Impact of medicare part D plan features on use of generic drugs.

PubMed

Tang, Yan; Gellad, Walid F; Men, Aiju; Donohue, Julie M

2014-06-01

Little is known about how Medicare Part D plan features influence choice of generic versus brand drugs. To examine the association between Part D plan features and generic medication use. Data from a 2009 random sample of 1.6 million fee-for-service, Part D enrollees aged 65 years and above, who were not dually eligible or receiving low-income subsidies, were used to examine the association between plan features (generic cost-sharing, difference in brand and generic copay, prior authorization, step therapy) and choice of generic antidepressants, antidiabetics, and statins. Logistic regression models accounting for plan-level clustering were adjusted for sociodemographic and health status. Generic cost-sharing ranged from $0 to $9 for antidepressants and statins, and from $0 to $8 for antidiabetics (across 5th-95th percentiles). Brand-generic cost-sharing differences were smallest for statins (5th-95th percentiles: $16-$37) and largest for antidepressants ($16-$64) across plans. Beneficiaries with higher generic cost-sharing had lower generic use [adjusted odds ratio (OR)=0.97, 95% confidence interval (CI), 0.95-0.98 for antidepressants; OR=0.97, 95% CI, 0.96-0.98 for antidiabetics; OR=0.94, 95% CI, 0.92-0.95 for statins]. Larger brand-generic cost-sharing differences and prior authorization were significantly associated with greater generic use in all categories. Plans could increase generic use by 5-12 percentage points by reducing generic cost-sharing from the 75th ($7) to 25th percentiles ($4-$5), increasing brand-generic cost-sharing differences from the 25th ($25-$26) to 75th ($32-$33) percentiles, and using prior authorization and step therapy. Cost-sharing features and utilization management tools were significantly associated with generic use in 3 commonly used medication categories.

Assessing Individual Lessons Using a Generic Teacher Observation Instrument: How Useful Is the International System for Teacher Observation and Feedback (ISTOF)?

ERIC Educational Resources Information Center

Muijs, Daniel; Reynolds, David; Sammons, Pamela; Kyriakides, Leonidas; Creemers, Bert P. M.; Teddlie, Charles

2018-01-01

Teacher effectiveness, which impacts student attainment even when controlling for student characteristics, is of key importance as a factor in educational effectiveness and improvement. Improving the quality of teaching is thus the primary means by which we can enhance student learning outcomes. Thus there has long been great interest in the…

A new extranodal scoring system based on the prognostically relevant extranodal sites in diffuse large B-cell lymphoma, not otherwise specified treated with chemoimmunotherapy.

PubMed

Hwang, Hee Sang; Yoon, Dok Hyun; Suh, Cheolwon; Huh, Jooryung

2016-08-01

Extranodal involvement is a well-known prognostic factor in patients with diffuse large B-cell lymphomas (DLBCL). Nevertheless, the prognostic impact of the extranodal scoring system included in the conventional international prognostic index (IPI) has been questioned in an era where rituximab treatment has become widespread. We investigated the prognostic impacts of individual sites of extranodal involvement in 761 patients with DLBCL who received rituximab-based chemoimmunotherapy. Subsequently, we established a new extranodal scoring system based on extranodal sites, showing significant prognostic correlation, and compared this system with conventional scoring systems, such as the IPI and the National Comprehensive Cancer Network-IPI (NCCN-IPI). An internal validation procedure, using bootstrapped samples, was also performed for both univariate and multivariate models. Using multivariate analysis with a backward variable selection, we found nine extranodal sites (the liver, lung, spleen, central nervous system, bone marrow, kidney, skin, adrenal glands, and peritoneum) that remained significant for use in the final model. Our newly established extranodal scoring system, based on these sites, was better correlated with patient survival than standard scoring systems, such as the IPI and the NCCN-IPI. Internal validation by bootstrapping demonstrated an improvement in model performance of our modified extranodal scoring system. Our new extranodal scoring system, based on the prognostically relevant sites, may improve the performance of conventional prognostic models of DLBCL in the rituximab era and warrants further external validation using large study populations.

Brand loyalty, patients and limited generic medicines uptake.

PubMed

Costa-Font, Joan; Rudisill, Caroline; Tan, Stefanie

2014-06-01

The sluggish development of European generic drug markets depends heavily on demand side factors, and more specifically, patients' and doctors' loyalty to branded products. Loyalty to originator drugs, to the point where originator prices rise upon generic entry has been described as the 'generics paradox'. Originator loyalty can emerge for a plethora of reasons; including costs, perceptions about quality and physician advice. We know very little about the behavioural underpinnings of brand loyalty from the consumer or patient standpoint. This paper attempts to test the extent to which patients are brand loyal by drawing upon Spain's 2002 Health Barometer survey as it includes questions about consumer acceptance of generics in a country with exceptionally low generic uptake and substitution at the time of the study. Our findings suggest that at least 13% of the population would not accept generics as substitutes to the originator. These results confirm evidence of brand loyalty for a minority. Alongside high levels of awareness of generics, we find that low cost-sharing levels explain consumer brand loyalty but their impact on acceptance of generic substitution is very small. Higher cost-sharing and exempting fewer patients from cost-sharing have the potential to encourage generic acceptance. Copyright © 2014 Elsevier Ireland Ltd. All rights reserved.

Establishing "abuse-deterrence equivalence" for generic abuse-deterrent opioid formulations: A proposed development framework.

PubMed

Setnik, Beatrice; Cone, Edward J

2016-01-01

Abuse-deterrent formulations are one strategy for mitigating the epidemic of prescription opioid abuse. Regulatory guidance documents describe the requirements for developing abuse-deterrent formulations of novel drugs and formulations; however, they do not address "abuse-deterrence equivalence" for generic formulations. As generics may be produced with different excipients and formulations compared to reference drugs, differences in their properties may impact their abuse-deterrent features. Currently, it is unclear what specific studies are needed to support generic abuse-deterrence claims. This commentary outlines several recommendations on the in vitro and in vivo testing required, including the conditions for conducting a human abuse potential study.

The impact on health outcome measures of switching to generic medicines consequent to reference pricing: the case of olanzapine in New Zealand.

PubMed

Lessing, Charon; Ashton, Toni; Davis, Peter B

2015-06-01

New Zealand's Pharmaceutical Management Agency (PHARMAC) manages the list of medicines available for prescribing with government subsidy, within a fixed annual medicines budget. PHARMAC achieves this through a mix of pricing strategies including reference pricing. In 2011, PHARMAC applied generic reference pricing to olanzapine tablets. This study sought to evaluate change in outcome measures of patients switching from originator to generic olanzapine consequent to the introduction of the policy. A retrospective study using national health data collections was conducted. Outcome measures included medicines indicators (change in dosage, concomitant therapy and treatment cessation), health care service indicators (use of emergency departments, hospitals and specialist services), surveillance reports of adverse events, and mortality. Subsequent to the removal of funding for originator brand olanzapine tablets, 99.7% of patients meeting the inclusion criteria switched to using generic olanzapine. Limited case reports of suspected therapeutic loss were received in the study time period. No increase in use of additional oral or injectable antipsychotic medication was observed after switching, nor any increase in other unique, non-antipsychotic prescription items. However, a high incidence of multiple switching between available brands was found. No net impact of switching brands on health service utilisation or mortality was found. The study shows that a switch can be made safely from originator olanzapine to a generic brand, and suggests that switching to generics should generally be viewed more positively. Generic reference pricing achieves considerable savings and, as a pricing policy, could be applied more widely.

HRQOL using SF36 (generic specific) in liver cirrhosis.

PubMed

Janani, K; Varghese, Joy; Jain, Mayank; Harika, Kavya; Srinivasan, Vijaya; Michael, Tom; Jayanthi, Venkataraman

2017-07-01

Health-related quality of life (HRQOL) is influenced by the disease state, associated complications and their management. In patients with liver cirrhosis co-morbidity, severity of liver disease and their complications are likely to affect the QOL. The aim of the study was to determine the factors that are likely to influence the domains of HRQOL using SF-36 in patients with liver cirrhosis. For the study, 149 patients with liver cirrhosis were compared with age-gender matched healthy controls for physical and mental components of SF-36 score and the effects of age, co-morbidity severity of liver disease and complications of liver cirrhosis on HRQOL were assessed using the same questionnaire. Results of the study showed that except for body pain, all the patients had a significantly low individual and composite domain score (p-value <0.0001) compared to age-gender matched controls. Patients below 45 years, Child-Turcotte-Pugh (CTP) C, a high model for end-stage liver disease (MELD) and higher rates of complication had low scores for body pain (KW p <0.005) and those above 55 years, for physical function (p <0.05). Both the physical components had a major impact on mental composite score (MCS) (KW p <0.05). Co-morbidity that included diabetes, hypertension and hypothyroid states in various combinations had no effect on SF-36 scores while co-morbid conditions like musculoskeletal pain, arthralgia etc. affected physical domains (physical function, body pain and role physical) and physical component score (PCS) (KW p <0.01 to <0.0001). By linear regression, MELD had a direct and significant association with overall PCS and mental component score (MCS).

Glucose variability negatively impacts long-term functional outcome in patients with traumatic brain injury.

PubMed

Matsushima, Kazuhide; Peng, Monica; Velasco, Carlos; Schaefer, Eric; Diaz-Arrastia, Ramon; Frankel, Heidi

2012-04-01

Significant glycemic excursions (so-called glucose variability) affect the outcome of generic critically ill patients but has not been well studied in patients with traumatic brain injury (TBI). The purpose of this study was to evaluate the impact of glucose variability on long-term functional outcome of patients with TBI. A noncomputerized tight glucose control protocol was used in our intensivist model surgical intensive care unit. The relationship between the glucose variability and long-term (a median of 6 months after injury) functional outcome defined by extended Glasgow Outcome Scale (GOSE) was analyzed using ordinal logistic regression models. Glucose variability was defined by SD and percentage of excursion (POE) from the preset range glucose level. A total of 109 patients with TBI under tight glucose control had long-term GOSE evaluated. In univariable analysis, there was a significant association between lower GOSE score and higher mean glucose, higher SD, POE more than 60, POE 80 to 150, and single episode of glucose less than 60 mg/dL but not POE 80 to 110. After adjusting for possible confounding variables in multivariable ordinal logistic regression models, higher SD, POE more than 60, POE 80 to 150, and single episode of glucose less than 60 mg/dL were significantly associated with lower GOSE score. Glucose variability was significantly associated with poorer long-term functional outcome in patients with TBI as measured by the GOSE score. Well-designed protocols to minimize glucose variability may be key in improving long-term functional outcome. Copyright © 2012 Elsevier Inc. All rights reserved.

Interpreting Quality of Life after Brain Injury Scores: Cross-Walk with the Short Form-36.

PubMed

Wilson, Lindsay; Marsden-Loftus, Isaac; Koskinen, Sanna; Bakx, Wilbert; Bullinger, Monika; Formisano, Rita; Maas, Andrew; Neugebauer, Edmund; Powell, Jane; Sarajuuri, Jaana; Sasse, Nadine; von Steinbuechel, Nicole; von Wild, Klaus; Truelle, Jean-Luc

2017-01-01

The Quality of Life after Brain Injury (QOLIBRI) instruments are traumatic brain injury (TBI)-specific assessments of health-related quality of life (HRQoL), with established validity and reliability. The purpose of the study is to help improve the interpretability of the two QOLIBRI summary scores (the QOLIBRI Total score and the QOLBRI Overall Scale [OS] score). An analysis was conducted of 761 patients with TBI who took part in the QOLIBRI validation studies. A cross-walk between QOLIBRI scores and the SF-36 Mental Component Summary norm-based scoring system was performed using geometric mean regression analysis. The exercise supports a previous suggestion that QOLIBRI Total scores <60 indicate low or impaired HRQoL and indicate that the corresponding score on the QOLIBRI-OS is <52. The percentage of cases in the sample that fell into the "impaired HRQoL" category was 36% for the Mental Component Summary, 38% for the QOLIBRI Total, and 39% for the QOLIBRI-OS. Relationships between the QOLIBRI scales and the Glasgow Outcome Scale-Extended (GOSE), as a measure of global function, are presented in the form of means and standard deviations that allow comparison with other studies, and data on age and sex are presented for the QOLIBRI-OS. While bearing in mind the potential imprecision of the comparison, the findings provide a framework for evaluating QOLIBRI summary scores in relation to generic HRQoL that improves their interpretability.

The Portuguese generic medicines market: a policy analysis

PubMed Central

Simoens, Steven

2008-01-01

Objectives: This study aims to conduct a descriptive analysis of the policy environment surrounding the generic medicines retail market in Portugal. The policy analysis focuses on supply-side measures (i.e. market access, pricing, reference-pricing and reimbursement of generic medicines) and demand-side measures (i.e. incentives for physicians to prescribe, for pharmacists to dispense and for patients to use generic medicines). Methods: The policy analysis was based on an international literature review. Also, a simulation exercise was carried out to compute potential savings from substituting generic for originator medicines in Portugal using IMS Health data. Results: Portugal has developed a successful generic medicines market by increasing reimbursement of generic medicines (until October 2005), by introducing a reference-pricing system, by encouraging physicians to prescribe by international non-proprietary name (INN), and by allowing generic substitution by pharmacists. However, the development of the generic medicines market has been hindered by the existence of copies, pricing regulation, certain features of the reference-pricing system, weak incentives for physicians to prescribe generic medicines and a financial disincentive for pharmacists to dispense generic medicines. Increased generic substitution would be expected to reduce public expenditure on originator medicines by 45%. Conclusions: The development of the Portuguese generic medicines market has mainly been fuelled by supply-side measures. To support the further expansion of the market, policy makers need to strengthen demand-side measures inciting physicians to prescribe, pharmacists to dispense and patients to use generic medicines. PMID:25152781

Keeping a Finger on the Pulse: Assessment and Tracking

ERIC Educational Resources Information Center

Walsh, Ed

2017-01-01

This article explores an approach to tracking student progress in GCSE courses that yields useful diagnostic information. As well as obtaining an overall score, teachers can learn more about some of the generic characteristics that affect performance.

A longitudinal examination of generic and occupational specific job demands, and work-related social support associated with burnout among nurses in Sweden.

PubMed

Sundin, L; Hochwälder, J; Lisspers, J

2011-01-01

Burnout is a familiar problem within nursing. This longitudinal study was designed to examine the roles that generic and occupational specific job demands (i.e. "pain and death", "patient and relative needs", "threats and violence", "professional worries"), and various work-related sources of support play in association with burnout in a sample of registered nurses in Sweden. A questionnaire was completed on two different occasions, by the same group of nurses from three hospitals and two primary health care centers. Nurses with initial low and moderate scores on emotional exhaustion (n=585) and depersonalization (n=631) were included in the logistic regression analyses. Initial scores, as well as four categories examining change over time in the predictors (unchanged low, improved, impaired, unchanged high), were associated with burnout approximately one year later. In the multivariate analyses, quantitative job demands and professional worries were associated with emotional exhaustion. Poor co-worker support was associated with depersonalization over time. This study suggests an association between generic as well as occupational specific job demands and emotional exhaustion. Furthermore, an association between poor co-worker support and depersonalization was suggested. Implications of these findings and recommended directions for future research are discussed.

Automatic control system generation for robot design validation

NASA Technical Reports Server (NTRS)

Bacon, James A. (Inventor); English, James D. (Inventor)

2012-01-01

The specification and drawings present a new method, system and software product for and apparatus for generating a robotic validation system for a robot design. The robotic validation system for the robot design of a robotic system is automatically generated by converting a robot design into a generic robotic description using a predetermined format, then generating a control system from the generic robotic description and finally updating robot design parameters of the robotic system with an analysis tool using both the generic robot description and the control system.

77 FR 22361 - Energy Northwest, Columbia Generating Station; Final Supplement 47 to the Generic Environmental...

Federal Register 2010, 2011, 2012, 2013, 2014

2012-04-13

...) solar power; (9) wind power; (10) biomass waste; (11) hydroelectric power; (12) ocean wave and current... Nuclear Plants AGENCY: Nuclear Regulatory Commission. ACTION: Final Supplement 47 to the Generic Environmental Impact Statement for License Renewal of Nuclear Plants; issuance. SUMMARY: Notice is hereby given...

Generic medicine pricing in Europe: current issues and future perspective.

PubMed

Simoens, Steven

2008-01-01

This editorial discusses a number of trends affecting the pricing of generic medicines in Europe. With respect to pricing, recent evidence has emerged that European generic medicine manufacturers face competition from Indian manufacturers; that the price level of generic medicines varies substantially between European countries; and that generic medicine manufacturers engage in competition by discount rather than price competition in France, The Netherlands and the UK. These trends suggest that there may be scope for further reducing the prices of generic medicines in several countries. In relation to reference pricing, most European countries have incorporated market incentives within reference pricing systems with a view to promoting price competition. The European experience indicates that the generic medicines industry delivers competitive prices under a reference pricing system if demand-side policies are in place that stimulate physicians, pharmacists and patients to use generic medicines. Finally, caution needs to be exercised when focusing on the drivers of generic medicine pricing as these drivers not only vary between countries, but may also vary within a country. Manufacturers of originator and generic medicines do not take a single pricing approach following patent expiry, but vary their pricing strategy from molecule to molecule.

Multiple Criteria Decision Analysis (MCDA) for evaluating new medicines in Health Technology Assessment and beyond: The Advance Value Framework.

PubMed

Angelis, Aris; Kanavos, Panos

2017-09-01

Escalating drug prices have catalysed the generation of numerous "value frameworks" with the aim of informing payers, clinicians and patients on the assessment and appraisal process of new medicines for the purpose of coverage and treatment selection decisions. Although this is an important step towards a more inclusive Value Based Assessment (VBA) approach, aspects of these frameworks are based on weak methodologies and could potentially result in misleading recommendations or decisions. In this paper, a Multiple Criteria Decision Analysis (MCDA) methodological process, based on Multi Attribute Value Theory (MAVT), is adopted for building a multi-criteria evaluation model. A five-stage model-building process is followed, using a top-down "value-focused thinking" approach, involving literature reviews and expert consultations. A generic value tree is structured capturing decision-makers' concerns for assessing the value of new medicines in the context of Health Technology Assessment (HTA) and in alignment with decision theory. The resulting value tree (Advance Value Tree) consists of three levels of criteria (top level criteria clusters, mid-level criteria, bottom level sub-criteria or attributes) relating to five key domains that can be explicitly measured and assessed: (a) burden of disease, (b) therapeutic impact, (c) safety profile (d) innovation level and (e) socioeconomic impact. A number of MAVT modelling techniques are introduced for operationalising (i.e. estimating) the model, for scoring the alternative treatment options, assigning relative weights of importance to the criteria, and combining scores and weights. Overall, the combination of these MCDA modelling techniques for the elicitation and construction of value preferences across the generic value tree provides a new value framework (Advance Value Framework) enabling the comprehensive measurement of value in a structured and transparent way. Given its flexibility to meet diverse requirements and become readily adaptable across different settings, the Advance Value Framework could be offered as a decision-support tool for evaluators and payers to aid coverage and reimbursement of new medicines. Copyright © 2017 The Authors. Published by Elsevier Ltd.. All rights reserved.

Responsiveness Comparison of the EQ-5D, PROMIS Global Health, and VR-12 Questionnaires in Knee Arthroscopy.

PubMed

Oak, Sameer R; Strnad, Gregory J; Bena, James; Farrow, Lutul D; Parker, Richard D; Jones, Morgan H; Spindler, Kurt P

2016-12-01

The EuroQol 5 dimensions questionnaire (EQ-5D), Patient-Reported Outcomes Measurement Information System (PROMIS) 10 Global Health, and Veterans RAND 12-Item Health Survey (VR-12) are generic patient-reported outcome (PRO) questionnaires that assess a patient's general health. In choosing a PRO to track general health status, it is necessary to consider which measure will be the most responsive to change after treatment. To date, no studies exist comparing responsiveness among the EQ-5D, PROMIS 10 Global Health, and the Veterans Rand 12-Item Health Survey (VR-12). To determine which of the generic PROs are most responsive internally and externally in the setting of knee arthroscopy. Cohort study (diagnosis); Level of evidence, 3. Fifty patients who underwent knee arthroscopy were surveyed preoperatively and a mean 3.6 months postoperatively, with 90% follow-up. PROs included the EQ-5D, EQ-5D visual analog scale, PROMIS 10 Global Health (PROMIS 10) physical and mental components, VR-12 physical and mental components, and the Knee injury and Osteoarthritis Outcome Score (KOOS)-pain subscale. Internal responsiveness was evaluated by performing paired t tests on the changes in measures and calculating 2 measures of effect size: Cohen d and standardized response mean (SRM). External responsiveness was evaluated by comparing Pearson correlation measures between the disease-specific reference KOOS-pain and generic PROs. For internal responsiveness, 3 PROs showed a statistically significant improvement in score after treatment (EQ-5D: +0.10 [95% CI, 0.06-0.15], VR-12 physical: +7.2 [95% CI, 4.0-10.4]), and PROMIS 10 physical: +4.4 [95% CI, 2.6-6.3]) and effect size statistics with moderate change (Cohen d and SRM, 0.5-0.8). Assessing external responsiveness, a high correlation with the disease-specific reference (KOOS-pain score) was found for EQ-5D (0.65), VR-12 physical (0.57), and PROMIS 10 physical (0.77). For both internal and external responsiveness, the EQ-5D, VR-12 physical, and PROMIS 10 physical showed significantly greater responsiveness compared with the other general PRO measures but no statistical differences among themselves. There is no statistical difference in internal or external responsiveness to change among the EQ-5D, VR-12 physical, and PROMIS 10 physical instruments. In tracking longitudinal patient health, researchers and administrators have the flexibility to choose any of the general PROs among the EQ-5D, VR-12 physical, and PROMIS 10 physical. We recommend that any study tracking PROs in knee arthroscopy include 1 of these generic instruments.

Impact of Site Elevation on Mg Smelter Design

NASA Astrophysics Data System (ADS)

Baker, Phillip W.

Site elevation has many surprising and significant impacts on the engineering design of metallurgical plant of all types. Electrolytic magnesium smelters maybe built at high elevation for a variety of reasons including availability of raw material, energy or electric power. Because of the unit processes they typically involve, Mg smelters can be extensively impacted by site elevation. In this paper, generic examples of the design changes required to adapt a smelter originally designed for sea level to operate at 2700 m are presented. While the examples are drawn from a magnesium plant design case, these changes are generically applicable to all industrial plants utilizing similar unit processes irrespective of product.

77 FR 28316 - Filing a Renewed License Application

Federal Register 2010, 2011, 2012, 2013, 2014

2012-05-14

... only those environmental impacts and alternatives that are reasonably foreseeable. This means that... action timeframe. With respect to assessing the potential future environmental impacts associated with... its consideration of impacts in the generic and supplemental environmental impact statements (SEISs...

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.

Methodological Considerations for Comparison of Brand Versus Generic Versus Authorized Generic Adverse Event Reports in the US Food and Drug Administration Adverse Event Reporting System (FAERS).

PubMed

Rahman, Md Motiur; Alatawi, Yasser; Cheng, Ning; Qian, Jingjing; Peissig, Peggy L; Berg, Richard L; Page, David C; Hansen, Richard A

2017-12-01

The US Food and Drug Administration Adverse Event Reporting System (FAERS), a post-marketing safety database, can be used to differentiate brand versus generic safety signals. To explore the methods for identifying and analyzing brand versus generic adverse event (AE) reports. Public release FAERS data from January 2004 to March 2015 were analyzed using alendronate and carbamazepine as examples. Reports were classified as brand, generic, and authorized generic (AG). Disproportionality analyses compared reporting odds ratios (RORs) of selected known labeled serious adverse events stratifying by brand, generic, and AG. The homogeneity of these RORs was compared using the Breslow-Day test. The AG versus generic was the primary focus since the AG is identical to brand but marketed as a generic, therefore minimizing generic perception bias. Sensitivity analyses explored how methodological approach influenced results. Based on 17,521 US event reports involving alendronate and 3733 US event reports involving carbamazepine (immediate and extended release), no consistently significant differences were observed across RORs for the AGs versus generics. Similar results were obtained when comparing reporting patterns over all time and just after generic entry. The most restrictive approach for classifying AE reports yielded smaller report counts but similar results. Differentiation of FAERS reports as brand versus generic requires careful attention to risk of product misclassification, but the relative stability of findings across varying assumptions supports the utility of these approaches for potential signal detection.

The Impact of Misspelled Words on Automated Computer Scoring: A Case Study of Scientific Explanations

NASA Astrophysics Data System (ADS)

Ha, Minsu; Nehm, Ross H.

2016-06-01

Automated computerized scoring systems (ACSSs) are being increasingly used to analyze text in many educational settings. Nevertheless, the impact of misspelled words (MSW) on scoring accuracy remains to be investigated in many domains, particularly jargon-rich disciplines such as the life sciences. Empirical studies confirm that MSW are a pervasive feature of human-generated text and that despite improvements, spell-check and auto-replace programs continue to be characterized by significant errors. Our study explored four research questions relating to MSW and text-based computer assessments: (1) Do English language learners (ELLs) produce equivalent magnitudes and types of spelling errors as non-ELLs? (2) To what degree do MSW impact concept-specific computer scoring rules? (3) What impact do MSW have on computer scoring accuracy? and (4) Are MSW more likely to impact false-positive or false-negative feedback to students? We found that although ELLs produced twice as many MSW as non-ELLs, MSW were relatively uncommon in our corpora. The MSW in the corpora were found to be important features of the computer scoring models. Although MSW did not significantly or meaningfully impact computer scoring efficacy across nine different computer scoring models, MSW had a greater impact on the scoring algorithms for naïve ideas than key concepts. Linguistic and concept redundancy in student responses explains the weak connection between MSW and scoring accuracy. Lastly, we found that MSW tend to have a greater impact on false-positive feedback. We discuss the implications of these findings for the development of next-generation science assessments.

German dentists' websites on periodontitis have low quality of information.

PubMed

Schwendicke, Falk; Stange, Jörg; Stange, Claudia; Graetz, Christian

2017-08-02

The internet is an increasingly relevant source of health information. We aimed to assess the quality of German dentists' websites on periodontitis, hypothesizing that it was significantly associated with a number of practice-specific parameters. We searched four electronic search engines and included pages which were freely accessible, posted by a dental practice in Germany, and mentioned periodontal disease/therapy. Websites were assessed for (1) technical and functional aspects, (2) generic quality and risk of bias, (3) disease-specific information. For 1 and 2, validated tools (LIDA/DISCERN) were used for assessment. For 3, we developed a criterion catalogue encompassing items on etiologic and prognostic factors for periodontitis, the diagnostic and treatment process, and the generic chance of tooth retention in periodontitis patients. Inter- and intra-rater reliabilities were largely moderate. Generalized linear modeling was used to assess the association between the information quality (measured as % of maximally available scores) and practice-specific characteristics. Seventy-one websites were included. Technical and functional aspects were reported in significantly higher quality (median: 71%, 25/75th percentiles: 67/79%) than all other aspects (p < 0.05). Generic risk of bias and most disease-specific aspects showed significantly lower reporting quality (median range was 0-40%), with poorest reporting for prognostic factors (9;0/27%), diagnostic process (0;0/33%) and chances of tooth retention (0;0/2%). We found none of the practice-specific parameters to have significant impact on the overall quality of the websites. Most German dentists' websites on periodontitis are not fully trustworthy and relevant information are not or insufficiently considered. There is great need to improve the information quality from such websites at least with regards to periodontitis.

Need for multicriteria evaluation of generic drug policies.

PubMed

Kaló, Zoltán; Holtorf, Anke-Peggy; Alfonso-Cristancho, Rafael; Shen, Jie; Ágh, Tamás; Inotai, András; Brixner, Diana

2015-03-01

Policymakers tend to focus on improving patented drug policies because they are under pressure from patients, physicians, and manufacturers to increase access to novel therapies. The success of pharmaceutical innovation over the last few decades has led to the availability of many off-patent drugs to treat disease areas with the greatest public health need. Therefore, the success of public health programs in improving the health status of the total population is highly dependent on the efficiency of generic drug policies. The objective of this article was to explore factors influencing the true efficiency of generic prescription drug policies in supporting public health initiatives in the developed world. Health care decision makers often assess the efficiency of generic drug policies by the level of price erosion and market share of generics. Drug quality, bioequivalence, in some cases drug formulations, supply reliability, medical adherence and persistence, health outcomes, and nondrug costs, however, are also attributes of success for generic drug policies. Further methodological research is needed to measure and improve the efficiency of generic drug policies. This also requires extension of the evidence base of the impact of generic drugs, partly based on real-world evidence. Multicriteria decision analysis may assist policymakers and researchers to evaluate the true value of generic drugs. Copyright © 2015. Published by Elsevier Inc.

The global biopharma industry and the rise of Indian drug multinationals: implications for Australian generics policy

PubMed Central

Löfgren, Hans

2007-01-01

This article provides a synopsis of the new dynamics of the global biopharma industry. The emergence of global generics companies with capabilities approximating those of 'big pharma' has accelerated the blurring of boundaries between the innovator and generics sectors. Biotechnology-based products form a large and growing segment of prescription drug markets and regulatory pathways for biogenerics are imminent. Indian biopharma multinationals with large-scale efficient manufacturing plants and growing R&D capabilities are now major suppliers of Active Pharmaceutical Ingredients (APIs) and generic drugs across both developed and developing countries. In response to generic competition, innovator companies employ a range of life cycle management techniques, including the launch of 'authorised generics'. The generics segment in Australia will see high growth rates in coming years but the prospect for local manufacturing is bleak. The availability of cheap generics in international markets has put pressure on Pharmaceutical Benefits Scheme (PBS) pricing arrangements, and a new policy direction was announced in November 2006. Lower generics prices will have a negative impact on some incumbent suppliers but industrial renewal policies for the medicines industry in Australia are better focused on higher value R&D activities and niche manufacturing of sophisticated products. PMID:17543115

Perspectives of physicians practicing in low and middle income countries towards generic medicines: a narrative review.

PubMed

Hassali, Mohamed Azmi; Wong, Zhi Yen; Alrasheedy, Alian A; Saleem, Fahad; Mohamad Yahaya, Abdul Haniff; Aljadhey, Hisham

2014-09-01

This review was conducted to document published literature related to physicians' knowledge, attitudes, and perceptions of generic medicines in low- and middle-income countries (LMICs) and to compare the findings with high-income countries. A systematic search of articles published in peer-reviewed journals from January 2001 to February 2013 was performed. The search comprised nine electronic databases. The search strategy involved using Boolean operators for combinations of the following terms: generic medicines, generic medications, generic drugs, generic, generic substitution, generic prescribing, international non-proprietary, prescribers, doctors, general practitioners, physicians, and specialists. Sixteen articles were included in this review. The majority (n=11) were from high income countries and five from LMICs. The main difference between high income countries and LMICs is that physicians from high income countries generally have positive views whereas those from LMICs tend to have mixed views regarding generic medicines. Few similarities were identified among different country income groups namely low level of physicians' knowledge of the basis of bioequivalence testing, cost of generic medicines as an encouraging factor for generic medicine prescribing, physicians' concerns towards safety and quality of generic medicines and effect of pharmaceutical sales representative on generic medicine prescribing. The present literature review revealed that physicians from LMICs tend to have mixed views regarding generic medicines. This may be due to differences in the health care system and pharmaceutical funding system, medicine policies, the level of educational interventions, and drug information sources in countries of different income levels. Copyright © 2014 Elsevier Ireland Ltd. All rights reserved.

Comparison between the disease-specific Airways Questionnaire 20 and the generic 15D instruments in COPD.

PubMed

Mazur, Witold; Kupiainen, Henna; Pitkäniemi, Janne; Kilpeläinen, Maritta; Sintonen, Harri; Lindqvist, Ari; Kinnula, Vuokko L; Laitinen, Tarja

2011-01-16

Given that the assessment of health-related quality of life (HRQoL) is an essential outcome measure to optimize chronic obstructive pulmonary disease (COPD) patient management, there is a need for a short and fast, reliable and valid instrument for routine use in clinical practice. The objective of this study was to analyse the relationship between the disease-specific Airways questionnaire (AQ20) and the generic 15D health-related quality of life (HRQoL) instrument simultaneously in a large cohort of patients with COPD. We also compare the HRQoL of COPD patients with that of the general population. The AQ20 and 15D were administered to 739 COPD patients representing an unselected hospital-based COPD population. The completion rates and validity of, and correlations among the questions and dimension scores were examined. A factor analysis with varimax rotation was performed in order to find subsets of highly correlating items of the questionnaires. The summary scores of AQ20 and 15D were highly correlated (r = - 0.71, p < 0.01). In AQ20 over 50% of patients reported frequent cough, breathlessness during domestic work, and chest problem limiting their full enjoyment of life. 15D results showed a noteworthy decrease of HRQoL in breathing, mobility, sleeping, usual activities, discomfort and symptoms, vitality, and sexual activity (scores ≤ 0.75). Compared to the age- and gender-standardized Finnish general population, the COPD patients were statistically significantly worse off on 13 of 15 dimensions. The AQ20 and 15D summary scores are comparable in terms of measuring HRQoL in COPD patients. The data support the validity of 15D to measure the quality of life in COPD. COPD compromises the HRQoL broadly, as reflected by the generic instrument. Both questionnaires are simple and short, and could easily be used in clinical practice with high completion rates.

Correlation of Head Impacts to Change in Balance Error Scoring System Scores in Division I Men's Lacrosse Players.

PubMed

Miyashita, Theresa L; Diakogeorgiou, Eleni; Marrie, Kaitlyn

Investigation into the effect of cumulative subconcussive head impacts has yielded various results in the literature, with many supporting a link to neurological deficits. Little research has been conducted on men's lacrosse and associated balance deficits from head impacts. (1) Athletes will commit more errors on the postseason Balance Error Scoring System (BESS) test. (2) There will be a positive correlation to change in BESS scores and head impact exposure data. Prospective longitudinal study. Level 3. Thirty-four Division I men's lacrosse players (age, 19.59 ± 1.42 years) wore helmets instrumented with a sensor to collect head impact exposure data over the course of a competitive season. Players completed a BESS test at the start and end of the competitive season. The number of errors from pre- to postseason increased during the double-leg stance on foam ( P < 0.001), tandem stance on foam ( P = 0.009), total number of errors on a firm surface ( P = 0.042), and total number of errors on a foam surface ( P = 0.007). There were significant correlations only between the total errors on a foam surface and linear acceleration ( P = 0.038, r = 0.36), head injury criteria ( P = 0.024, r = 0.39), and Gadd Severity Index scores ( P = 0.031, r = 0.37). Changes in the total number of errors on a foam surface may be considered a sensitive measure to detect balance deficits associated with cumulative subconcussive head impacts sustained over the course of 1 lacrosse season, as measured by average linear acceleration, head injury criteria, and Gadd Severity Index scores. If there is microtrauma to the vestibular system due to repetitive subconcussive impacts, only an assessment that highly stresses the vestibular system may be able to detect these changes. Cumulative subconcussive impacts may result in neurocognitive dysfunction, including balance deficits, which are associated with an increased risk for injury. The development of a strategy to reduce total number of head impacts may curb the associated sequelae. Incorporation of a modified BESS test, firm surface only, may not be recommended as it may not detect changes due to repetitive impacts over the course of a competitive season.

What Works Clearinghouse Quick Review: "Incentives, Selection, and Teacher Performance: Evidence from IMPACT"

ERIC Educational Resources Information Center

What Works Clearinghouse, 2013

2013-01-01

This study examined the effect of IMPACT on teacher retention and performance. IMPACT is a high-stakes teacher evaluation system used in the District of Columbia public schools that gives teachers scores reflecting their performance in the classroom and the achievement of their students. Based on these scores, teachers were assigned to one of four…

Comparison of brand versus generic antiepileptic drug adverse event reporting rates in the U.S. Food and Drug Administration Adverse Event Reporting System (FAERS).

PubMed

Rahman, Md Motiur; Alatawi, Yasser; Cheng, Ning; Qian, Jingjing; Plotkina, Annya V; Peissig, Peggy L; Berg, Richard L; Page, David; Hansen, Richard A

2017-09-01

Despite the cost saving role of generic anti-epileptic drugs (AEDs), debate exists as to whether generic substitution of branded AEDs may lead to therapeutic failure and increased toxicity. This study compared adverse event (AE) reporting rates for brand vs. authorized generic (AG) vs. generic AEDs. Since AGs are pharmaceutically identical to brand but perceived as generics, the generic vs. AG comparison minimized potential bias against generics. Events reported to the U.S. Food and Drug Administration Adverse Event Reporting System between January 2004 to March 2015 with lamotrigine, carbamazepine, and oxcarbazepine listed as primary or secondary suspect were classified as brand, generic, or AG based on the manufacturer. Disproportionality analyses using the reporting odds ratio (ROR) assessed the relative rate of reporting of labeled AEs compared to reporting these events with all other drugs. The Breslow-Day statistic compared RORs across brand, AG, and other generics using a Bonferroni-corrected P<0.01. A total of 27,150 events with lamotrigine, 13,950 events with carbamazepine, and 5077 events with oxcarbazepine were reported, with generics accounting for 27%, 41%, and 32% of reports, respectively. Although RORs for the majority of known AEs were different between brand and generics for all three drugs of interest (Breslow-Day P<0.001), RORs generally were similar for AG and generic comparisons. Generic lamotrigine and carbamazepine were more commonly involved in reports of suicide or suicidal ideation compared with the respective AGs based on a multiple comparison-adjusted P<0.01. Similar AED reporting rates were observed for the AG and generic comparisons for most outcomes and drugs, suggesting that brands and generics have similar reporting rates after accounting for generic perception biases. Disproportional suicide reporting was observed for generics compared with AGs and brand, although this finding needs further study. Copyright © 2017 Elsevier B.V. All rights reserved.

Patient-reported outcome measures in arthroplasty registries

PubMed Central

Eresian Chenok, Kate; Bohm, Eric; Lübbeke, Anne; Denissen, Geke; Dunn, Jennifer; Lyman, Stephen; Franklin, Patricia; Dunbar, Michael; Overgaard, Søren; Garellick, Göran; Dawson, Jill

2016-01-01

The International Society of Arthroplasty Registries (ISAR) Steering Committee established the Patient-Reported Outcome Measures (PROMs) Working Group to convene, evaluate, and advise on best practices in the selection, administration, and interpretation of PROMs and to support the adoption and use of PROMs for hip and knee arthroplasty in registries worldwide. The 2 main types of PROMs include generic (general health) PROMs, which provide a measure of general health for any health state, and specific PROMs, which focus on specific symptoms, diseases, organs, body regions, or body functions. The establishment of a PROM instrument requires the fulfillment of methodological standards and rigorous testing to ensure that it is valid, reliable, responsive, and acceptable to the intended population. A survey of the 41 ISAR member registries showed that 8 registries administered a PROMs program that covered all elective hip or knee arthroplasty patients and 6 registries collected PROMs for sample populations; 1 other registry had planned but had not started collection of PROMs. The most common generic instruments used were the EuroQol 5 dimension health outcome survey (EQ-5D) and the Short Form 12 health survey (SF-12) or the similar Veterans RAND 12-item health survey (VR-12). The most common specific PROMs were the Hip disability and Osteoarthritis Outcome Score (HOOS), the Knee injury and Osteoarthritis Outcome Score (KOOS), the Oxford Hip Score (OHS), the Oxford Knee Score (OKS), the Western Ontario and McMaster Universities Arthritis Index (WOMAC), and the University of California at Los Angeles Activity Score (UCLA). PMID:27168175

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.

Impact of the Minimum Pricing Policy and introduction of brand (generic) substitution into the Pharmaceutical Benefits Scheme in Australia.

PubMed

McManus, P; Birkett, D J; Dudley, J; Stevens, A

2001-01-01

To describe the effects of introducing the Minimum Pricing Policy (MPP) and generic (brand) substitution in 1990 and 1994 respectively on the dispensing of Pharmaceutical Benefits Scheme (PBS) prescriptions both at the aggregate and individual patient level. The relative proportion of prescriptions with a brand premium and those at benchmark was examined 4 years after introduction of the MPP and again 5 years later after generic substitution by pharmacists was permitted. To determine the impact of a price signal at the individual level, case studies involving a patient tracking methodology were conducted on two drugs (fluoxetine and ranitidine) that received a brand premium. From a zero base when the MPP was introduced in 1990, there were 5.4 million prescriptions (17%) dispensed for benchmark products 4 years later in 1994. At this stage generic (brand) substitution by pharmacists was then permitted and the market share of benchmark brands increased to 45% (25.2 million) by 1999. In the patient tracking studies, a significantly lower proportion of patients was still taking the premium brand of fluoxetine 3 months after the introduction of a price signal compared with patients taking paroxetine which did not have a generic competitor. This was also the case for the premium brand of ranitidine when compared to famotidine. The size of the price signal also had a marked effect on dispensing behaviour with the drug with the larger premium (fluoxetine) showing a significantly greater switch away from the premium brand to the benchmark product. The introduction in 1990 of the Minimum Pricing Policy without allowing generic substitution had a relatively small impact on the selection of medicines within the Pharmaceutical Benefits Scheme. However the effect of generic substitution at the pharmacist level, which was introduced in December 1994, resulted in a marked increase in the percentage of eligible PBS items dispensed at benchmark. Case studies showed a larger premium resulted in a greater shift of patients from drugs with a brand premium to the benchmark alternative.

10 CFR 51.23 - Temporary storage of spent fuel after cessation of reactor operation-generic determination of no...

Code of Federal Regulations, 2013 CFR

2013-01-01

... 10 Energy 2 2013-01-01 2013-01-01 false Temporary storage of spent fuel after cessation of reactor operation-generic determination of no significant environmental impact. 51.23 Section 51.23 Energy NUCLEAR REGULATORY COMMISSION (CONTINUED) ENVIRONMENTAL PROTECTION REGULATIONS FOR DOMESTIC LICENSING AND RELATED...

10 CFR 51.53 - Postconstruction environmental reports.

Code of Federal Regulations, 2011 CFR

2011-01-01

... impact statement; supplements to the final environmental impact statement, including supplements prepared at the license renewal stage; NRC staff-prepared final generic environmental impact statements; and... reflect new information in addition to that discussed in the final environmental impact statement prepared...

Analysis of composition-based metagenomic classification.

PubMed

Higashi, Susan; Barreto, André da Motta Salles; Cantão, Maurício Egidio; de Vasconcelos, Ana Tereza Ribeiro

2012-01-01

An essential step of a metagenomic study is the taxonomic classification, that is, the identification of the taxonomic lineage of the organisms in a given sample. The taxonomic classification process involves a series of decisions. Currently, in the context of metagenomics, such decisions are usually based on empirical studies that consider one specific type of classifier. In this study we propose a general framework for analyzing the impact that several decisions can have on the classification problem. Instead of focusing on any specific classifier, we define a generic score function that provides a measure of the difficulty of the classification task. Using this framework, we analyze the impact of the following parameters on the taxonomic classification problem: (i) the length of n-mers used to encode the metagenomic sequences, (ii) the similarity measure used to compare sequences, and (iii) the type of taxonomic classification, which can be conventional or hierarchical, depending on whether the classification process occurs in a single shot or in several steps according to the taxonomic tree. We defined a score function that measures the degree of separability of the taxonomic classes under a given configuration induced by the parameters above. We conducted an extensive computational experiment and found out that reasonable values for the parameters of interest could be (i) intermediate values of n, the length of the n-mers; (ii) any similarity measure, because all of them resulted in similar scores; and (iii) the hierarchical strategy, which performed better in all of the cases. As expected, short n-mers generate lower configuration scores because they give rise to frequency vectors that represent distinct sequences in a similar way. On the other hand, large values for n result in sparse frequency vectors that represent differently metagenomic fragments that are in fact similar, also leading to low configuration scores. Regarding the similarity measure, in contrast to our expectations, the variation of the measures did not change the configuration scores significantly. Finally, the hierarchical strategy was more effective than the conventional strategy, which suggests that, instead of using a single classifier, one should adopt multiple classifiers organized as a hierarchy.

Long-term Medicaid excess payments from alleged price manipulation of generic lorazepam.

PubMed

Bian, Boyang; Gorevski, Elizabeth; Kelton, Christina M L; Guo, Jeff J; Martin Boone, Jill E

2012-09-01

Cost savings from the use of generic drugs versus brand-name drugs are well known. Both private and public prescription drug plans encourage the use of generic drugs through a variety of mechanisms. The magnitude of cost savings for a given generic drug is dependent on the degree to which the generic market is competitive. Should the competitive structure become compromised, higher prices and reduced cost savings may result. An alleged conspiracy between Mylan Laboratories and its active-ingredient suppliers in 1997 was associated with an increase in seller concentration in the generic lorazepam market. The Federal Trade Commission (FTC) alleged that Mylan raised costs to consumers by $120 million because of price increases for generic lorazepam from March through December 1998 and for generic clorazepate from January through December 1998. In November 2002, a settlement with Mylan was approved by the FTC, and a federal district court required Mylan to pay $147 million, including $28.2 million to state agencies including Medicaid. To (a) describe the seller concentration in the national Medicaid generic lorazepam market over a 19-year period from January 1991 through December 2009, (b) estimate the excess payments for generic lorazepam by Medicaid between 1998 and 2009, and (c) investigate potentially increased utilization and prices of 2 substitute pharmaceuticals: branded lorazepam (Ativan) and generic alprazolam (another widely used intermediate-acting benzodiazepine). Using Medicaid State Drug Utilization Data from the Centers for Medicare Medicaid Services, we calculated the 4-firm concentration ratio (CR₄) and the Herfindahl-Hirschman Index (HHI) for the Medicaid generic lorazepam market, along with pre-rebate reimbursement for pharmacy claims, number of claims (utilization), and average pre-rebate reimbursement per claim (average "price") for generic lorazepam, from 1991 through 2009. Medicaid's excess payments were estimated under 2 different assumptions regarding what the average generic lorazepam price would have been in the absence of the alleged conspiracy. To find counterfactual prices, the average per-claim reimbursement for lorazepam for the 4 quarters prior to the alleged conspiracy, $6.80, was inflated using (a) the quarterly change in the average per-claim reimbursement for generic alprazolam and (b) the Consumer Price Index (CPI) for all urban consumers, all goods. Potential impact of the alleged conspiracy on the branded lorazepam and generic alprazolam markets was investigated. The average pre-rebate reimbursements per claim for generic lorazepam were $10.25, $23.12, and $8.48 in 1991, 1998, and 2009, respectively. For the same 3 years, CR₄ = 52.80, 76.02, and 86.74, while HHI = 905.71, 2,166.25, and 2,233.36. Medicaid's excess payments from 1998-2009 were estimated at approximately $625-$657 million. The data also suggest the possibility of small impacts on the utilization of branded lorazepam and the price of generic alprazolam. Prior to the alleged conspiracy in 1997, average pre-rebate reimbursement per claim for generic lorazepam was declining, while seller concentration was rising. After a jump in average payment per claim in the years immediately following the alleged conspiracy, prices have gradually returned to their pre-1998 levels. However, the generic lorazepam market was more concentrated in 2009 than prior to the alleged conspiracy. Copyright © 2012, Academy of Managed Care Pharmacy. All rights reserved.

Patented Drug Extension Strategies on Healthcare Spending: A Cost-Evaluation Analysis

PubMed Central

Vernaz, Nathalie; Haller, Guy; Girardin, François; Huttner, Benedikt; Combescure, Christophe; Dayer, Pierre; Muscionico, Daniel; Salomon, Jean-Luc; Bonnabry, Pascal

2013-01-01

Background Drug manufacturers have developed “evergreening” strategies to compete with generic medication after patent termination. These include marketing of slightly modified follow-on drugs. We aimed to estimate the financial impact of these drugs on overall healthcare costs and also to examine the impact of listing these drugs in hospital restrictive drug formularies (RDFs) on the healthcare system as a whole (“spillover effect”). Methods and Findings We used hospital and community pharmacy invoice office data in the Swiss canton of Geneva to calculate utilisation of eight follow-on drugs in defined daily doses between 2000 and 2008. “Extra costs” were calculated for three different scenarios assuming replacement with the corresponding generic equivalent for prescriptions of (1) all brand (i.e., initially patented) drugs, (2) all follow-on drugs, or (3) brand and follow-on drugs. To examine the financial spillover effect we calculated a monthly follow-on drug market share in defined daily doses for medications prescribed by hospital physicians but dispensed in community pharmacies, in comparison to drugs prescribed by non-hospital physicians in the community. Estimated “extra costs” over the study period were €15.9 (95% CI 15.5; 16.2) million for scenario 1, €14.4 (95% CI 14.1; 14.7) million for scenario 2, and €30.3 (95% CI 29.8; 30.8) million for scenario 3. The impact of strictly switching all patients using proton-pump inhibitors to esomeprazole at admission resulted in a spillover “extra cost” of €330,300 (95% CI 276,100; 383,800), whereas strictly switching to generic cetirizine resulted in savings of €7,700 (95% CI 4,100; 11,100). Overall we estimated that the RDF resulted in “extra costs” of €503,600 (95% CI 444,500; 563,100). Conclusions Evergreening strategies have been successful in maintaining market share in Geneva, offsetting competition by generics and cost containment policies. Hospitals may be contributing to increased overall healthcare costs by listing follow-on drugs in their RDF. Therefore, healthcare providers and policy makers should be aware of the impact of evergreening strategies. Please see later in the article for the Editors' Summary PMID:23750120

The complex legal and ethical issues related to generic medications. Viral hepatitis: a case study.

PubMed

Danta, M; Ghinea, N

2017-04-01

The economic impact of medications is significant, with many countries unable to afford the essential medicines listed by the WHO. Generic medications are one strategy to address this issue. Generic medications are similar to but not the same as originator medications. They have a significant cost advantage because they do not require the background research and development studies to support registration. Consequently, they are gaining increased market share in both the developed and developing world. Many new medications are now licensed to generic manufacturers in the developing world. As a result, it is possible for patients to bypass regulatory and cost barriers by importing medications directly from generic producers. Importation of the novel hepatitis C direct-acting antiviral therapy into Australia before it was registered in the country is an illustrative case study. This review will characterise generic medications and some of the legal and ethical issues around their utilisation, focusing on the relevant players, including pharma, government, patients and doctors.

Clinical Equivalence of Generic and Brand-Name Drugs Used in Cardiovascular Disease

PubMed Central

Kesselheim, Aaron S.; Misono, Alexander S.; Lee, Joy L.; Stedman, Margaret R.; Brookhart, M. Alan; Choudhry, Niteesh K.; Shrank, William H.

2009-01-01

Context Use of generic drugs, which are bioequivalent to brand-name drugs, can help contain prescription drug spending. However, there is concern among patients and physicians that brand-name drugs may be clinically superior to generic drugs. Objectives To summarize clinical evidence comparing generic and brand-name drugs used in cardiovascular disease and to assess the perspectives of editorialists on this issue. Data Sources Systematic searches of peer-reviewed publications in MEDLINE, EMBASE, and International Pharmaceutical Abstracts from January 1984 to August 2008. Study Selection Studies compared generic and brand-name cardiovascular drugs using clinical efficacy and safety end points. We separately identified editorials addressing generic substitution. Data Extraction We extracted variables related to the study design, setting, participants, clinical end points, and funding. Methodological quality of the trials was assessed by Jadad and Newcastle-Ottawa scores, and a meta-analysis was performed to determine an aggregate effect size. For editorials, we categorized authors’ positions on generic substitution as negative, positive, or neutral. Results We identified 47 articles covering 9 subclasses of cardiovascular medications, of which 38 (81%) were randomized controlled trials (RCTs). Clinical equivalence was noted in 7 of 7 RCTs (100%) of β-blockers, 10 of 11 RCTs (91%) of diuretics, 5 of 7 RCTs (71%) of calcium channel blockers, 3 of 3 RCTs (100%) of antiplatelet agents, 2 of 2 RCTs (100%) of statins, 1 of 1 RCT (100%) of angiotensin-converting enzyme inhibitors, and 1 of 1 RCT (100%) of α-blockers. Among narrow therapeutic index drugs, clinical equivalence was reported in 1 of 1 RCT (100%) of class 1 antiarrhythmic agents and 5 of 5 RCTs (100%) of warfarin. Aggregate effect size (n = 837) was −0.03 (95% confidence interval, −0.15 to 0.08), indicating no evidence of superiority of brand-name to generic drugs. Among 43 editorials, 23 (53%) expressed a negative view of generic drug substitution. Conclusions Whereas evidence does not support the notion that brand-name drugs used in cardiovascular disease are superior to generic drugs, a substantial number of editorials counsel against the interchangeability of generic drugs. PMID:19050195

Site-specific temporal and spatial validation of a generic plant pest forecast system with observations of Bactrocera dorsalis (oriental fruit fly).

USDA-ARS?s Scientific Manuscript database

This study introduces a simple generic model, the Generic Pest Forecast System (GPFS), for simulatingthe relative populations of non-indigenousarthropod pests in space and time. The model was designed to calculate the population index or relative population using hourly weather dataas influenced by...

A mixed-method study on the generic and ostomy-specific quality of life of cancer and non-cancer ostomy patients.

PubMed

Jansen, Femke; van Uden-Kraan, Cornelia F; Braakman, J Annemieke; van Keizerswaard, Paulina M; Witte, Birgit I; Verdonck-de Leeuw, Irma M

2015-06-01

The aim of this study is to compare the generic and ostomy-specific quality of life (QoL) between cancer and non-cancer ostomy patients using a mixed-method design. All patients with an ostomy participating in the Stomapanel of the Dutch Ostomy Association were asked to complete a generic (RAND-36) and ostomy-specific (Stoma-QoL) QoL questionnaire. In addition, open-ended questions on symptoms, restrictions or adaptations influencing daily life were included. The generic and ostomy-specific QoL between cancer and non-cancer ostomy patients were compared using linear regression analyses. Qualitative responses were analysed using content analysis. In total, 668 patients were included: 379 cancer patients (80 % colorectal, 17 % bladder and 3 % other) and 289 non-cancer patients (38 % colitis ulcerosa, 22 % Crohn's disease and 40 % other) with a colostomy (55 %), ileostomy (31 %) and/or urostomy (16 %). Adjusted for gender, age, type of ostomy and time elapsed since ostomy surgery, cancer ostomy patients scored higher (better) on Stoma-QoL (β = 2.1) and all RAND-36 domains (9.1 < β ≤ 19.5) except on mental health compared to non-cancer ostomy patients. Of the 33 themes coded for in the content analysis, fatigue or sleeplessness, leakages, pain, bladder or bowel complaints, physical functioning or activity, travelling or being away from home, other daily activities (including work), clothing and diet were among the 10 most frequently reported themes, although ranking differed between both patient groups. Besides, cancer ostomy patients frequently reported on the impact on (engaging in a) relationship or sexual intimacy and non-cancer ostomy patients frequently reported to be relieved of symptoms and restrictions in daily life. Cancer patients reported better generic and ostomy-specific QoL than non-cancer ostomy patients. In both cancer and non-cancer ostomy patients, fatigue or sleeplessness, leakages, pain, bladder or bowel complaints, physical functioning or activity, travelling or being away from home, other daily activities (including work), clothing and diet were among the 10 most common reported themes influencing daily life. However, the ranking of these 10 most common themes was different in both patient groups.

Impact of delayed information in sub-second complex systems

NASA Astrophysics Data System (ADS)

Manrique, Pedro D.; Zheng, Minzhang; Johnson Restrepo, D. Dylan; Hui, Pak Ming; Johnson, Neil F.

What happens when you slow down the delivery of information in large-scale complex systems that operate faster than the blink of an eye? This question just adopted immediate commercial, legal and political importance following U.S. regulators' decision to allow an intentional 350 microsecond delay to be added in the ultrafast network of financial exchanges. However there is still no scientific understanding available to policymakers of the potential system-wide impact of such delays. Here we take a first step in addressing this question using a minimal model of a population of competing, heterogeneous, adaptive agents which has previously been shown to produce similar statistical features to real markets. We find that while certain extreme system-level behaviors can be prevented by such delays, the duration of others is increased. This leads to a highly non-trivial relationship between delays and system-wide instabilities which warrants deeper empirical investigation. The generic nature of our model suggests there should be a fairly wide class of complex systems where such delay-driven extreme behaviors can arise, e.g. sub-second delays in brain function possibly impacting individuals' behavior, and sub-second delays in navigational systems potentially impacting the safety of driverless vehicles.

Technology requirements for a generic aerocapture system. [for atmospheric entry

NASA Technical Reports Server (NTRS)

Cruz, M. I.

1980-01-01

The technology requirements for the design of a generic aerocapture vehicle system are summarized. These spacecraft have the capability of completely eliminating fuel-costly retropropulsion for planetary orbit capture through a single aerodynamically controlled atmospheric braking pass from a hyperbolic trajectory into a near circular orbit. This generic system has application at both the inner and outer planets. Spacecraft design integration, navigation, communications, and aerothermal protection system design problems were assessed in the technology requirements study and are discussed in this paper.

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.

Specialty-specific multi-source feedback: assuring validity, informing training.

PubMed

Davies, Helena; Archer, Julian; Bateman, Adrian; Dewar, Sandra; Crossley, Jim; Grant, Janet; Southgate, Lesley

2008-10-01

The white paper 'Trust, Assurance and Safety: the Regulation of Health Professionals in the 21st Century' proposes a single, generic multi-source feedback (MSF) instrument in the UK. Multi-source feedback was proposed as part of the assessment programme for Year 1 specialty training in histopathology. An existing instrument was modified following blueprinting against the histopathology curriculum to establish content validity. Trainees were also assessed using an objective structured practical examination (OSPE). Factor analysis and correlation between trainees' OSPE performance and the MSF were used to explore validity. All 92 trainees participated and the assessor response rate was 93%. Reliability was acceptable with eight assessors (95% confidence interval 0.38). Factor analysis revealed two factors: 'generic' and 'histopathology'. Pearson correlation of MSF scores with OSPE performances was 0.48 (P = 0.001) and the histopathology factor correlated more highly (histopathology r = 0.54, generic r = 0.42; t = - 2.76, d.f. = 89, P < 0.01). Trainees scored least highly in relation to ability to use histopathology to solve clinical problems (mean = 4.39) and provision of good reports (mean = 4.39). Three of six doctors whose means were < 4.0 received free text comments about report writing. There were 83 forms with aggregate scores of < 4. Of these, 19.2% included comments about report writing. Specialty-specific MSF is feasible and achieves satisfactory reliability. The higher correlation of the 'histopathology' factor with the OSPE supports validity. This paper highlights the importance of validating an MSF instrument within the specialty-specific context as, in addition to assuring content validity, the PATH-SPRAT (Histopathology-Sheffield Peer Review Assessment Tool) also demonstrates the potential to inform training as part of a quality improvement model.

12-month generic health status and psychological distress outcomes following an Australian natural disaster experience: 2009 Black Saturday Wildfires.

PubMed

Wasiak, J; Mahar, P; Lee, S; Paul, E; Spinks, A; Pfitzer, B; Cleland, H; Gabbe, B

2013-11-01

To describe the generic health status, health-related quality of life and psychological distress over a 12-month period of burns patients affected by the 2009 Black Saturday Wildfires. Cohort study with retrospective assessment of pre-injury status and prospective assessment of physical and psychosocial functioning in the Black Saturday Wildfires burns patients across time. Generic health status and burn specific quality of life using the 36-item Short Form Health Survey (SF-36) and Burn Specific Health Scale (BSHS) were collected at three, six and twelve months post-burn injury. In addition, similar time points were used to measure level of psychological distress and the presence of pain using the Kessler-10 questionnaire (K-10) and the McGill Pain Questionnaire. At 12 months post-injury, patients reported a mean 16.4 (standard error, SE: 3.2) reduction in physical health and a 5.3 (SE 2.5) reduction in mental health scores of the SF-36 as compared to their pre-injury scores, with significant decreases observed in the "bodily pain", "physical functioning", "role physical" and "vitality" subscales. High levels of psychological distress and persistent pain were experienced, with no significant changes during the study period to the overall burns specific quality of life. Even 12 months post-burn injury, patients affected by the 2009 Victorian Wildfires still experienced a significant reduction in generic health, increased psychological distress and persistent pain. The need for early and ongoing identification of physical and psychosocial impairments during hospital admission and upon discharge could be helpful to establish systematic interdisciplinary goals for long-term rehabilitation after severe burn injury. Copyright © 2012 Elsevier Ltd. All rights reserved.

The desirable qualities of future doctors--a study of medical student perceptions.

PubMed

Hurwitz, Steven; Kelly, Brian; Powis, David; Smyth, Robyn; Lewin, Terry

2013-07-01

There is a lack of consensus regarding the qualities possessed by the ideal doctor, and very limited research regarding the views of medical students on these qualities. To investigate the views of commencing medical students regarding the desirable qualities of doctors. A survey containing a set of proposed desirable qualities of doctors identified from the existing literature was completed by 158 first-year medical students. The survey had a 75% response rate. Students rated the individual qualities of empathy, motivation to be a doctor, good verbal communication, ethically sound, integrity and honesty as the most important. A factor analysis identified six categories of qualities: methodical processing, cognitive capacity, people skills, generic work ethic, role certainty and warmth. Significant differences in factor scores were found across subgroups of students (international and domestic students, with and without prior tertiary studies) on the following factors: methodical processing, which was scored highest by domestic students with prior tertiary studies, cognitive capacity, which was scored highest by domestic students without prior tertiary studies and generic work ethic, which was scored highest by international students. Medical students identified a range of desirable personal qualities of a doctor which varied according to student characteristics, including their prior educational experience. Future research aiming to define such desirable qualities should include a broader range of stakeholders, including students at different training levels and institutions.

Co-calibrating quality-of-life scores from three pulmonary disorders: implications for comparative-effectiveness research.

PubMed

Rouse, M; Twiss, J; McKenna, S P

2016-06-01

Background Efficient use of health resources requires accurate outcome assessment. Disease-specific patient-reported outcome (PRO) measures are designed to be highly relevant to patients with a specific disease. They have advantages over generic PROs that lack relevance to patient groups and miss crucial impacts of illness. It is thought that disease-specific measurement cannot be used in comparative effectiveness research (CER). The present study provides further evidence of the value of disease-specific measures in making valid comparisons across diseases. Methods The Asthma Life Impact Scale (ALIS, 22 items), Living with Chronic Obstructive Pulmonary Disease (LCOPD, 22 items) scale, and Cambridge Pulmonary Hypertension Outcome Review (CAMPHOR, 25 items) were completed by 140, 162, and 91 patients, respectively. The three samples were analyzed for fit to the Rasch model, then combined into a scale consisting of 58 unique items and re-analyzed. Raw scores on the three measures were co-calibrated and a transformation table produced. Results The scales fit the Rasch model individually (ALIS Chi(2) probability value (p-Chi(2)) = 0.05; LCOPD p-Chi(2 )=( )0.38; CAMPHOR p-Chi(2 )=( )0.92). The combined data also fit the Rasch model (p-Chi(2 )=( )0.22). There was no differential item functioning related to age, gender, or disease. The co-calibrated scales successfully distinguished between perceived severity groups (p < 0.001). Limitations The samples were drawn from different sources. For scales to be co-calibrated using a common item design, they must be based on the same theoretical construct, be unidimensional, and have overlapping items. Conclusions The results showed that it is possible to co-calibrate scores from disease-specific PRO measures. This will permit more accurate and sensitive outcome measurement to be incorporated into CER. The co-calibration of needs-based disease-specific measures allows the calculation of γ scores that can be used to compare directly the impact of any type of interventions on any diseases included in the co-calibration.

On macroeconomic characteristics of pharmaceutical generics and the potential for manufacturing and consumption under fuzzy conditions.

PubMed

Gascón, Fernando; de la Fuente, David; Puente, Javier; Lozano, Jesús

2007-11-01

The aim of this paper is to develop a methodology that is useful for analyzing, from a macroeconomic perspective, the aggregate demand and the aggregate supply features of the market of pharmaceutical generics. In order to determine the potential consumption and the potential production of pharmaceutical generics in different countries, two fuzzy decision support systems are proposed. Two fuzzy decision support systems, both based on the Mamdani model, were applied in this paper. These systems, generated by Matlab Toolbox 'Fuzzy' (v. 2.0), are able to determine the potential of a country for the manufacturing or the consumption of pharmaceutical generics. The systems make use of three macroeconomic input variables. In an empirical application of our proposed methodology, the potential towards consumption and manufacturing in Holland, Sweden, Italy and Spain has been estimated from national indicators. Cross-country comparisons are made and graphical surfaces are analyzed in order to interpret the results. The main contribution of this work is the development of a methodology that is useful for analyzing aggregate demand and aggregate supply characteristics of pharmaceutical generics. The methodology is valid for carrying out a systematic analysis of the potential generics have at a macrolevel in different countries. The main advantages of the use of fuzzy decision support systems in the context of pharmaceutical generics are the flexibility in the construction of the system, the speed in interpreting the results offered by the inference and surface maps and the ease with which a sensitivity analysis of the potential behavior of a given country may be performed.

Impact of permafrost development on groundwater flow patterns: a numerical study considering freezing cycles on a two-dimensional vertical cut through a generic river-plain system

NASA Astrophysics Data System (ADS)

Grenier, Christophe; Régnier, Damien; Mouche, Emmanuel; Benabderrahmane, Hakim; Costard, François; Davy, Philippe

2013-02-01

The impact of glaciation cycles on groundwater flow was studied within the framework of nuclear waste storage in underground geological formations. The eastern section of the Paris Basin (a layered aquifer with impervious/pervious alternations) in France was considered for the last 120 ka. Cold periods corresponded with arid climates. The issue of talik development below water bodies was addressed. These unfrozen zones can maintain open pathways for aquifer recharge. Transient thermal evolution was simulated on a small-scale generic unit of the landscape including a "river" and "plain". Coupled thermo-hydraulic modeling and simplified conductive heat transfer were considered for a broad range of scenarios. The results showed that when considering the current limited river dimensions and purely conductive heat transfer, taliks are expected to close within a few centuries. However, including coupled advection for flows from the river to the plain (probably pertinent for the eastern Paris Basin aquifer recharge zones) strongly delays talik closure (millennium scale). The impact on regional underground flows is expected to vary from a complete stop of recharge to a reduced recharge, corresponding to the talik zones. Consequences for future modeling approaches of the Paris Basin are discussed.

Simulation of Biomimetic Recognition between Polymers and Surfaces

NASA Astrophysics Data System (ADS)

Golumbfskie, Aaron J.; Pande, Vijay S.; Chakraborty, Arup K.

1999-10-01

Many biological processes, such as transmembrane signaling and pathogen-host interactions, are initiated by a protein recognizing a specific pattern of binding sites on part of a membrane or cell surface. By recognition, we imply that the polymer quickly finds and then adsorbs strongly on the pattern-matched region and not on others. The development of synthetic systems that can mimic such recognition between polymers and surfaces could have significant impact on advanced applications such as the development of sensors, molecular-scale separation processes, and synthetic viral inhibition agents. Attempting to affect recognition in synthetic systems by copying the detailed chemistries to which nature has been led over millenia of evolution does not seem practical for most applications. This leads us to the following question: Are there any universal strategies that can affect recognition between polymers and surfaces? Such generic strategies may be easier to implement in abiotic applications. We describe results that suggest that biomimetic recognition between synthetic polymers and surfaces is possible by exploiting certain generic strategies, and we elucidate the kinetic mechanisms by which this occurs. Our results suggest convenient model systems for experimental studies of dynamics in free energy landscapes characteristic of frustrated systems.

A generic model to simulate air-borne diseases as a function of crop architecture.

PubMed

Casadebaig, Pierre; Quesnel, Gauthier; Langlais, Michel; Faivre, Robert

2012-01-01

In a context of pesticide use reduction, alternatives to chemical-based crop protection strategies are needed to control diseases. Crop and plant architectures can be viewed as levers to control disease outbreaks by affecting microclimate within the canopy or pathogen transmission between plants. Modeling and simulation is a key approach to help analyze the behaviour of such systems where direct observations are difficult and tedious. Modeling permits the joining of concepts from ecophysiology and epidemiology to define structures and functions generic enough to describe a wide range of epidemiological dynamics. Additionally, this conception should minimize computing time by both limiting the complexity and setting an efficient software implementation. In this paper, our aim was to present a model that suited these constraints so it could first be used as a research and teaching tool to promote discussions about epidemic management in cropping systems. The system was modelled as a combination of individual hosts (population of plants or organs) and infectious agents (pathogens) whose contacts are restricted through a network of connections. The system dynamics were described at an individual scale. Additional attention was given to the identification of generic properties of host-pathogen systems to widen the model's applicability domain. Two specific pathosystems with contrasted crop architectures were considered: ascochyta blight on pea (homogeneously layered canopy) and potato late blight (lattice of individualized plants). The model behavior was assessed by simulation and sensitivity analysis and these results were discussed against the model ability to discriminate between the defined types of epidemics. Crop traits related to disease avoidance resulting in a low exposure, a slow dispersal or a de-synchronization of plant and pathogen cycles were shown to strongly impact the disease severity at the crop scale.

A generic coding approach for the examination of meal patterns.

PubMed

Woolhead, Clara; Gibney, Michael J; Walsh, Marianne C; Brennan, Lorraine; Gibney, Eileen R

2015-08-01

Meal pattern analysis can be complex because of the large variability in meal consumption. The use of aggregated, generic meal data may address some of these issues. The objective was to develop a meal coding system and use it to explore meal patterns. Dietary data were used from the National Adult Nutrition Survey (2008-2010), which collected 4-d food diary information from 1500 healthy adults. Self-recorded meal types were listed for each food item. Common food group combinations were identified to generate a number of generic meals for each meal type: breakfast, light meals, main meals, snacks, and beverages. Mean nutritional compositions of the generic meals were determined and substituted into the data set to produce a generic meal data set. Statistical comparisons were performed against the original National Adult Nutrition Survey data. Principal component analysis was carried out by using these generic meals to identify meal patterns. A total of 21,948 individual meals were reduced to 63 generic meals. Good agreement was seen for nutritional comparisons (original compared with generic data sets mean ± SD), such as fat (75.7 ± 29.4 and 71.7 ± 12.9 g, respectively, P = 0.243) and protein (83.3 ± 26.9 and 80.1 ± 13.4 g, respectively, P = 0.525). Similarly, Bland-Altman plots demonstrated good agreement (<5% outside limits of agreement) for many nutrients, including protein, saturated fat, and polyunsaturated fat. Twelve meal types were identified from the principal component analysis ranging in meal-type inclusion/exclusion, varying in energy-dense meals, and differing in the constituents of the meals. A novel meal coding system was developed; dietary intake data were recoded by using generic meal consumption data. Analysis revealed that the generic meal coding system may be appropriate when examining nutrient intakes in the population. Furthermore, such a coding system was shown to be suitable for use in determining meal-based dietary patterns. © 2015 American Society for Nutrition.

Health-related quality of life among children with adenoid hypertrophy in Xi'an, China.

PubMed

Jiang, Xun; Ren, Xiaoyong; Liu, Haiqin; Tian, Jiao; Du, Chunyan; Luo, Huanan; Cheng, Ying; Shang, Lei

2015-12-01

The aim of this study was to investigate the health-related quality of life (HRQOL) in 5-7-year-old children diagnosed with adenoid hypertrophy and the impact of adenoid hypertrophy on affected families. This is a cross-sectional case-control study evaluating 5-7-year-old children with adenoid hypertrophy (n=195), 5-7-year-old healthy children (n=156), and associated caregivers (parents and/or grandparents). A Chinese version of the PedsQL™ 4.0 Generic Core Scale was used to assess childhood HRQOL, and a Chinese version of the Family Impact Module (FIM) was used to assess the impact of adenoid hypertrophy on family members. HRQOL scores were compared between the children with adenoid hypertrophy and healthy children. In addition, a multiple step-wise regression with demographic variables of children and their caregivers, family economic status, and caregiver's HRQOL as independent variables were referenced to determine the factors that may influence HRQOL in children with adenoid hypertrophy. Children with adenoid hypertrophy showed significantly lower physical, emotional, social, and school functioning scores than healthy children (p<0.001 in all these dimensions). Caregivers for children with adenoid hypertrophy also scored significantly lower than caregivers for healthy children on physical, emotional, social, cognitive, and communication functioning (p<0.001 in all these dimensions). Caregivers for adenoid hypertrophy-affected children also exhibited significantly higher levels of worry than healthy children (p<0.001). Multivariate analyses demonstrated that children's age, children's relation with caregivers, caregiver's educational level, caregiver's own HRQOL, and the size of adenoid may all influence the HRQOL in children with adenoid hypertrophy (p<0.05). The current data suggested that adenoid hypertrophy were associated with lower HRQOL in both children and their caregivers, and may negatively influence family functioning. In addition, caregivers' social characteristics may also significantly affect the HRQOL in children with adenoid hypertrophy. Copyright © 2015 Elsevier Ireland Ltd. All rights reserved.

Efficient creation of multipartite entanglement in flux qubits.

PubMed

Ferber, J; Wilhelm, F K

2010-07-09

We investigate three superconducting flux qubits coupled in a loop. In this setup, tripartite entanglement can be created in a natural, controllable, and stable way. Both generic kinds of tripartite entanglement--the W type as well as the GHZ type entanglement--can be identified among the eigenstates. We also discuss the violation of Bell inequalities in this system and show the impact of a limited measurement fidelity on the detection of entanglement and quantum nonlocality.

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

Impact of Landfill Closure Designs on Long-Term Natural Attenuation of Chlorinated Hydrocarbons

DTIC Science & Technology

2008-10-01

Parsons, 2004). The bioreactor provides a source of leachable organic material for the CAH-contaminated aquifer, which is used by native microorganisms ...bioreactor concept is not new. “Bioreactor” is a generic term for a system that degrades contaminants using microorganisms . Bioreactors have been used in a...of CAHs (USEPA, 1998) and using prior experience monitoring enhanced bioremediation sites. The bioreactor was sampled to monitor the chemical and

The Impact of Instructor's Group Management Strategies on Students' Attitudes to Group Work and Generic Skill Development

ERIC Educational Resources Information Center

Natoli, Riccardo; Jackling, Beverley; Seelanatha, Lalith

2014-01-01

This paper examines the influence of two distinct group work management strategies on finance students' attitudes towards group work and their perceptions of generic skill development. Using quantitative and qualitative data, comparisons are made between students who experienced a supportive group work environment and students who experienced an…

Achieving Synergies through Generic Skills: A Strength of Online Communities

ERIC Educational Resources Information Center

Clarkson, Barnard; Brook, Chris

2007-01-01

Educators are often torn between impositions of the institution in which they work and the imperatives of their individual courses or units and the impact this tension might have on student satisfaction with the learning experience. It is common to hear that students must graduate with multiple generic attributes or skills, yet these skills may…

Generic maintenance immunosuppression in solid organ transplant recipients.

PubMed

Ensor, Christopher R; Trofe-Clark, Jennifer; Gabardi, Steven; McDevitt-Potter, Lisa M; Shullo, Michael A

2011-11-01

Survival after solid organ transplantation has increased in the era of tacrolimus and mycophenolate. This increased survival could be due in part to the broad clinical use of these potent and specific agents for maintenance immunosuppression. These drugs have enhanced specificity and potency for T and B lymphocytes compared with their predecessors, cyclosporine and azathioprine. Between 2008 and 2010, the United States Food and Drug Administration approved several generic formulations of both tacrolimus and mycophenolate mofetil. Deciding whether generic products can be safely substituted for the innovator product is a clinical dilemma similar to that which occurred when generic formulations of cyclosporine became available. We describe the concerns regarding generic immunosuppression use, summarize expert opinion and consensus statements in transplantation, analyze the potential impact of generic substitution, and provide estimates of populations affected based on generic drug market penetration. Formulary considerations such as cost, availability, and potential drug ordering and drug selection errors are described, and transplant coordinator and patient perspectives are reviewed. Finally, general recommendations about the use of generic maintenance immunosuppression in solid organ transplant recipients are provided. Although more research is needed to confirm clinical and therapeutic equivalence and pharmacoeconomic benefit, generic immunosuppressants can be safely substituted for innovator products as long as patients consistently receive the same product, patients and clinicians are aware of when substitutions occur, and enhanced therapeutic drug monitoring is provided during the transition.

Assessing eco-efficiency: A metafrontier directional distance function approach using life cycle analysis

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

Beltrán-Esteve, Mercedes, E-mail: mercedes.beltran@uv.es; Reig-Martínez, Ernest; Estruch-Guitart, Vicent

Sustainability analysis requires a joint assessment of environmental, social and economic aspects of production processes. Here we propose the use of Life Cycle Analysis (LCA), a metafrontier (MF) directional distance function (DDF) approach, and Data Envelopment Analysis (DEA), to assess technological and managerial differences in eco-efficiency between production systems. We use LCA to compute six environmental and health impacts associated with the production processes of nearly 200 Spanish citrus farms belonging to organic and conventional farming systems. DEA is then employed to obtain joint economic-environmental farm's scores that we refer to as eco-efficiency. DDF allows us to determine farms' globalmore » eco-efficiency scores, as well as eco-efficiency scores with respect to specific environmental impacts. Furthermore, the use of an MF helps us to disentangle technological and managerial eco-inefficiencies by comparing the eco-efficiency of both farming systems with regards to a common benchmark. Our core results suggest that the shift from conventional to organic farming technology would allow a potential reduction in environmental impacts of 80% without resulting in any decline in economic performance. In contrast, as regards farmers' managerial capacities, both systems display quite similar mean scores.« less

Equivalence and interchangeability of narrow therapeutic index drugs in organ transplantation

PubMed Central

Johnston, Atholl

2013-01-01

The calcineurin inhibitors (CNIs), ciclosporin and tacrolimus, are the mainstay of immunosuppression in solid organ transplantation. Generic formulations of these drugs are now available. With increasing pressure on healthcare budgets and the consequent need to match health expectations to available resources, substitution with a generic product appears an attractive option to reduce costs. Approval of generic products differs from innovator drugs, and narrow therapeutic index drugs (NTIs; including CNIs) bring their own particular considerations. With NTIs, small variations in drug exposure could result in reduced immunosuppression or drug toxicity with potentially adverse effects on patient outcomes. NTIs are subject to stricter regulatory approval versus many other generic drugs. However, different generic formulations may still not necessarily be therapeutically equivalent in individuals, raising the possibility of significant differences in exposure between products. Although regional recommendations vary, many guidelines emphasise the need for NTI drug substitution to be initiated by the transplant physician, thus ensuring careful therapeutic monitoring and reduced negative patient impact. The need for therapeutic monitoring during generic substitution has important implications for the overall costs of generic treatment as these costs have to be factored in to the potential savings made from using generic formulations. The reduced acquisition costs of generic products may not necessarily translate into lower overall healthcare costs. This article examines the issue of equivalence and interchangeability of NTI drugs used in organ transplantation, the implications of the approval process for generic drugs on treatment efficacy and safety, and the effective management of substitutions between products. PMID:24089632

Health system challenges to integration of mental health delivery in primary care in Kenya--perspectives of primary care health workers.

PubMed

Jenkins, Rachel; Othieno, Caleb; Okeyo, Stephen; Aruwa, Julyan; Kingora, James; Jenkins, Ben

2013-09-30

Health system weaknesses in Africa are broadly well known, constraining progress on reducing the burden of both communicable and non-communicable disease (Afr Health Monitor, Special issue, 2011, 14-24), and the key challenges in leadership, governance, health workforce, medical products, vaccines and technologies, information, finance and service delivery have been well described (Int Arch Med, 2008, 1:27). This paper uses focus group methodology to explore health worker perspectives on the challenges posed to integration of mental health into primary care by generic health system weakness. Two ninety minute focus groups were conducted in Nyanza province, a poor agricultural region of Kenya, with 20 health workers drawn from a randomised controlled trial to evaluate the impact of a mental health training programme for primary care, 10 from the intervention group clinics where staff had received the training programme, and 10 health workers from the control group where staff had not received the training). These focus group discussions suggested that there are a number of generic health system weaknesses in Kenya which impact on the ability of health workers to care for clients with mental health problems and to implement new skills acquired during a mental health continuing professional development training programmes. These weaknesses include the medicine supply, health management information system, district level supervision to primary care clinics, the lack of attention to mental health in the national health sector targets, and especially its absence in district level targets, which results in the exclusion of mental health from such district level supervision as exists, and the lack of awareness in the district management team about mental health. The lack of mental health coverage included in HIV training courses experienced by the health workers was also striking, as was the intensive focus during district supervision on HIV to the detriment of other health issues. Generic health system weaknesses in Kenya impact on efforts for horizontal integration of mental health into routine primary care practice, and greatly frustrate health worker efforts.Improvement of medicine supplies, information systems, explicit inclusion of mental health in district level targets, management and supervision to primary care are likely to greatly improve primary care health worker effectiveness, and enable training programmes to be followed by better use in the field of newly acquired skills. A major lever for horizontal integration of mental health into the health system would be the inclusion of mental health in the national health sector reform strategy at community, primary care and district levels rather than just at the higher provincial and national levels, so that supportive supervision from the district level to primary care would become routine practice rather than very scarce activity. Trial registration ISRCTN 53515024.

The impact on health outcomes and healthcare utilisation of switching to generic medicines consequent to reference pricing: the case of lamotrigine in New Zealand.

PubMed

Lessing, Charon; Ashton, Toni; Davis, Peter

2014-10-01

Many countries have implemented generic reference pricing and substitution as methods of containing pharmaceutical expenditure. However, resistance to switching between medicines is apparent, especially in the case of anti-epileptic medicines. This study sought to exploit a nation-wide policy intervention on generic reference pricing in New Zealand to evaluate the health outcomes of patients switching from originator to generic lamotrigine, an anti-epileptic medicine. A retrospective study using the national health collections and prescription records was conducted comparing patients who switched from originator brand to generic lamotrigine with patients who remained on the originator brand. Primary outcome measures included switch behaviour, changes in utilisation of healthcare services at emergency departments, hospitalisations and use of specialist services, and mortality. Approximately one-quarter of all patients using the originator brand of lamotrigine switched to generic lamotrigine, half of whom made the switch within 60 days of the policy implementation. Multiple switches (three or more) between generic and brand products were evident for around 10% of switchers. Switch-back rates of 3% were apparent within 30 days post-switch. No difference in heath outcome measures was associated with switching from originator lamotrigine to a generic equivalent and hence no increased costs could be found for switchers. Switching from brand to generic lamotrigine is largely devoid of adverse health outcomes; however, creating an incentive to ensure a greater proportion of patients switch to generic lamotrigine is required to achieve maximal financial savings from a policy of generic reference pricing.

How Criterion Scores Predict the Overall Impact Score and Funding Outcomes for National Institutes of Health Peer-Reviewed Applications.

PubMed

Eblen, Matthew K; Wagner, Robin M; RoyChowdhury, Deepshikha; Patel, Katherine C; Pearson, Katrina

2016-01-01

Understanding the factors associated with successful funding outcomes of research project grant (R01) applications is critical for the biomedical research community. R01 applications are evaluated through the National Institutes of Health (NIH) peer review system, where peer reviewers are asked to evaluate and assign scores to five research criteria when assessing an application's scientific and technical merit. This study examined the relationship of the five research criterion scores to the Overall Impact score and the likelihood of being funded for over 123,700 competing R01 applications for fiscal years 2010 through 2013. The relationships of other application and applicant characteristics, including demographics, to scoring and funding outcomes were studied as well. The analyses showed that the Approach and, to a lesser extent, the Significance criterion scores were the main predictors of an R01 application's Overall Impact score and its likelihood of being funded. Applicants might consider these findings when submitting future R01 applications to NIH.

How Criterion Scores Predict the Overall Impact Score and Funding Outcomes for National Institutes of Health Peer-Reviewed Applications

PubMed Central

Eblen, Matthew K.; Wagner, Robin M.; RoyChowdhury, Deepshikha; Patel, Katherine C.; Pearson, Katrina

2016-01-01

Understanding the factors associated with successful funding outcomes of research project grant (R01) applications is critical for the biomedical research community. R01 applications are evaluated through the National Institutes of Health (NIH) peer review system, where peer reviewers are asked to evaluate and assign scores to five research criteria when assessing an application’s scientific and technical merit. This study examined the relationship of the five research criterion scores to the Overall Impact score and the likelihood of being funded for over 123,700 competing R01 applications for fiscal years 2010 through 2013. The relationships of other application and applicant characteristics, including demographics, to scoring and funding outcomes were studied as well. The analyses showed that the Approach and, to a lesser extent, the Significance criterion scores were the main predictors of an R01 application’s Overall Impact score and its likelihood of being funded. Applicants might consider these findings when submitting future R01 applications to NIH. PMID:27249058

Can Functional Movement Assessment Predict Football Head Impact Biomechanics?

PubMed

Ford, Julia M; Campbell, Kody R; Ford, Cassie B; Boyd, Kenneth E; Padua, Darin A; Mihalik, Jason P

2018-06-01

The purposes of this study was to determine functional movement assessments' ability to predict head impact biomechanics in college football players and to determine whether head impact biomechanics could explain preseason to postseason changes in functional movement performance. Participants (N = 44; mass, 109.0 ± 20.8 kg; age, 20.0 ± 1.3 yr) underwent two preseason and postseason functional movement assessment screenings: 1) Fusionetics Movement Efficiency Test and 2) Landing Error Scoring System (LESS). Fusionetics is scored 0 to 100, and participants were categorized into the following movement quality groups as previously published: good (≥75), moderate (50-75), and poor (<50). The LESS is scored 0 to 17, and participants were categorized into the following previously published movement quality groups: good (≤5 errors), moderate (6-7 errors), and poor (>7 errors). The Head Impact Telemetry (HIT) System measured head impact frequency and magnitude (linear acceleration and rotational acceleration). An encoder with six single-axis accelerometers was inserted between the padding of a commercially available Riddell football helmet. We used random intercepts general linear-mixed models to analyze our data. There were no effects of preseason movement assessment group on the two Head Impact Telemetry System impact outcomes: linear acceleration and rotational acceleration. Head impact frequency did not significantly predict preseason to postseason score changes obtained from the Fusionetics (F1,36 = 0.22, P = 0.643, R = 0.006) or the LESS (F1,36 < 0.01, P = 0.988, R < 0.001) assessments. Previous research has demonstrated an association between concussion and musculoskeletal injury, as well as functional movement assessment performance and musculoskeletal injury. The functional movement assessments chosen may not be sensitive enough to detect neurological and neuromuscular differences within the sample and subtle changes after sustaining head impacts.

Health-related quality of life and treatment satisfaction in patients with gout: results from a cross-sectional study in a managed care setting.

PubMed

Khanna, Puja P; Shiozawa, Aki; Walker, Valery; Bancroft, Tim; Essoi, Breanna; Akhras, Kasem S; Khanna, Dinesh

2015-01-01

Patient satisfaction with treatment directly impacts adherence to medication. The objective was to assess and compare treatment satisfaction with the Treatment Satisfaction Questionnaire for Medication (TSQM), gout-specific health-related quality of life (HRQoL) with the Gout Impact Scale (GIS), and generic HRQoL with the SF-12v2(®) Health Survey (SF-12) in patients with gout in a real-world practice setting. This cross-sectional mail survey included gout patients enrolled in a large commercial health plan in the US. Patients were ≥18 years with self-reported gout diagnosis, who filled ≥1 prescription for febuxostat during April 26, 2012 to July 26, 2012 and were not taking any other urate-lowering therapies. The survey included the TSQM version II (TSQM vII, score 0-100, higher scores indicate better satisfaction), GIS (score 0-100, higher scores indicate worse condition), and SF-12 (physical component summary and mental component summary). Patients were stratified by self-report of currently experiencing a gout attack or not to assess the discriminant ability of the questionnaires. A total of 257 patients were included in the analysis (mean age, 54.9 years; 87% male). Patients with current gout attack (n=29, 11%) had worse scores than those without gout attack on most instrument scales. Mean differences between current attack and no current attack for the TSQM domains were: -20.6, effectiveness; -10.6, side effects; -12.1, global satisfaction (all P<0.05); and -6.1, convenience (NS). For the GIS, mean differences were: 30.5, gout overall concern; 14.6, gout medication side effects; 22.7, unmet gout treatment needs; 11.5, gout concern during attack (all P<0.05); and 7.9, well-being during attack (NS). Mean difference in SF-12 was -6.6 for physical component summary (P<0.05) and -2.9 for mental component summary (NS). Correlations between several TSQM and GIS scales were moderate. The TSQM and GIS were complementary in evaluating the impact of gout flare on treatment satisfaction and HRQoL. Correlations between the two instruments supported the relationship between treatment satisfaction and HRQoL.

Health-related quality of life and treatment satisfaction in patients with gout: results from a cross-sectional study in a managed care setting

PubMed Central

Khanna, Puja P; Shiozawa, Aki; Walker, Valery; Bancroft, Tim; Essoi, Breanna; Akhras, Kasem S; Khanna, Dinesh

2015-01-01

Background Patient satisfaction with treatment directly impacts adherence to medication. Objective The objective was to assess and compare treatment satisfaction with the Treatment Satisfaction Questionnaire for Medication (TSQM), gout-specific health-related quality of life (HRQoL) with the Gout Impact Scale (GIS), and generic HRQoL with the SF-12v2® Health Survey (SF-12) in patients with gout in a real-world practice setting. Methods This cross-sectional mail survey included gout patients enrolled in a large commercial health plan in the US. Patients were ≥18 years with self-reported gout diagnosis, who filled ≥1 prescription for febuxostat during April 26, 2012 to July 26, 2012 and were not taking any other urate-lowering therapies. The survey included the TSQM version II (TSQM vII, score 0–100, higher scores indicate better satisfaction), GIS (score 0–100, higher scores indicate worse condition), and SF-12 (physical component summary and mental component summary). Patients were stratified by self-report of currently experiencing a gout attack or not to assess the discriminant ability of the questionnaires. Results A total of 257 patients were included in the analysis (mean age, 54.9 years; 87% male). Patients with current gout attack (n=29, 11%) had worse scores than those without gout attack on most instrument scales. Mean differences between current attack and no current attack for the TSQM domains were: −20.6, effectiveness; −10.6, side effects; −12.1, global satisfaction (all P<0.05); and −6.1, convenience (NS). For the GIS, mean differences were: 30.5, gout overall concern; 14.6, gout medication side effects; 22.7, unmet gout treatment needs; 11.5, gout concern during attack (all P<0.05); and 7.9, well-being during attack (NS). Mean difference in SF-12 was −6.6 for physical component summary (P<0.05) and −2.9 for mental component summary (NS). Correlations between several TSQM and GIS scales were moderate. Conclusion The TSQM and GIS were complementary in evaluating the impact of gout flare on treatment satisfaction and HRQoL. Correlations between the two instruments supported the relationship between treatment satisfaction and HRQoL. PMID:26185426

Impact of the introduction of mandatory generic substitution in South Africa: private sector sales of generic and originator medicines for chronic diseases.

PubMed

Gray, Andrew Lofts; Santa-Ana-Tellez, Yared; J Wirtz, Veronika

2016-12-01

To assess the impact of mandatory offer of generic substitution, introduced in South Africa in May 2003, on private sector sales of generic and originator medicines for chronic diseases. Private sector sales data (June 2001 to May 2005) were obtained from IMS Health for proton pump inhibitors (PPIs; ATC code A02BC), HMG-CoA reductase inhibitors (statins; C10AA), dihydropyridine calcium antagonists (C08CA), angiotensin-converting enzyme inhibitors (ACE-I; C09AA) and selective serotonin reuptake inhibitors (SSRIs; N06AB). Monthly sales were expressed as defined daily doses per 1000 insured population per month (DDD/TIM). Interrupted time-series models were used to estimate the changes in slope and level of medicines use after the policy change. ARIMA models were used to correct for autocorrelation and stationarity. Only the SSRIs saw a significant rise in level of generic utilisation (0.2 DDD/TIM; P < 0.001) and a fall in originator usage (-0.1 DDD/TIM; P < 0.001) after the policy change. Utilisation of generic PPIs fell (level 0.06 DDD/TIM, P = 0.048; slope 0.01 DDD/TIM, P = 0.043), but utilisation of originator products also grew (level 0.05 DDD/TIM, P < 0.001; slope 0.003, P = 0.001). Generic calcium antagonists and ACE-I showed an increase in slope (0.01 DDD/TIM, P = 0.016; 0.02 DDD/TIM, P < 0.001), while the originators showed a decrease in slope (-0.003 DDD/TIM, P = 0.046; -0.01 DDD/TIM, P < 0.001). There were insufficient data on generic statin use before the policy change to allow for analysis. The mandatory offer of generic substitution appeared to have had a quantifiable effect on utilisation patterns in the 2 years after May 2003. Managed care interventions that were already in place before the intervention may have blunted the extent of the changes seen in this period. Generic policies are an important enabling provision for cost-containment efforts. However, decisions taken outside of official policy may anticipate or differ from that policy, with important consequences. © 2016 John Wiley & Sons Ltd.

EQ-5D-5L and SF-6D Utility Measures in Symptomatic benign Thyroid Nodules: Acceptability and Psychometric Evaluation.

PubMed

Wong, Carlos K H; Lang, Brian H H; Yu, Hill M S; Lam, Cindy L K

2017-08-01

The aim of this study was to examine the acceptability, validity, and reliability of the EuroQoL Five-Dimension Five-Level (EQ-5D-5L) and Short-Form Six-Dimension (SF-6D) health utility measures in patients with symptomatic benign thyroid nodules. Data from a randomized controlled trial (ClinicalTrials.gov identifier: NCT02398721) of 294 patients with symptomatic benign thyroid nodules were utilized for this psychometric evaluation of health-related quality of life (HR-QOL) measurement. Three HR-QOL questionnaires-the generic 12-item Short Form Health Survey (SF-12v2), EQ-5D-5L, and SF-6D-were interviewer-administered at baseline and 2 weeks afterwards. Responses to SF-6D were transformed to SF-6D utility scores using a Hong Kong population scoring algorithm derived by standard gamble, whereas responses to EQ-5D-5L were mapped onto EQ-5D-3L response via interim mapping algorithms and then converted to EQ-5D-5L utility scores using a Chinese-specific value set. Construct validity was determined by evaluating Spearman correlation between SF-12v2 scores and utility scores. Two-week test-retest reliability was assessed using intra-class correlation coefficient. No significant (>15%) floor and ceiling effects were observed for SF-6D utility scores. The SF-6D utility scores had a moderate Spearman rank correlation with the SF-12v2 domain score providing evidence for adequate construct validity. The SF-6D utility scores showed good test-retest reliability (0.794; range 0.696-0.860). Better reliability was observed in SF-6D utility scores than in EQ-5D-5L utility scores. While the EQ-5D-5L instrument was less reproducible, the SF-6D instrument appeared to be an applicable, valid, and reliable measure in assessing the HR-QOL of Chinese patients with symptomatic benign thyroid nodules. The impact of utility score selection on the effectiveness and cost effectiveness of clinical interventions targeted to these patients needs further exploration. NCT02398721, ClinicalTrials.gov.

Advanced, Adaptive, Modular, Distributed, Generic Universal FADEC Framework for Intelligent Propulsion Control Systems (Preprint)

DTIC Science & Technology

2007-09-01

AFRL-RZ-WP-TP-2008-2044 ADVANCED, ADAPTIVE, MODULAR, DISTRIBUTED, GENERIC UNIVERSAL FADEC FRAMEWORK FOR INTELLIGENT PROPULSION CONTROL...GRANT NUMBER 4. TITLE AND SUBTITLE ADVANCED, ADAPTIVE, MODULAR, DISTRIBUTED, GENERIC UNIVERSAL FADEC FRAMEWORK FOR INTELLIGENT PROPULSION... FADEC is unique and expensive to develop, produce, maintain, and upgrade for its particular application. Each FADEC is a centralized system, with a

An ideal-typical model for comparing interprofessional relations and skill mix in health care.

PubMed

Schönfelder, Walter; Nilsen, Elin Anita

2016-11-08

Comparisons of health system performance, including the regulations of interprofessional relations and the skill mix between health professions are challenging. National strategies for regulating interprofessional relations vary widely across European health care systems. Unambiguously defined and generally accepted performance indicators have to remain generic, with limited power for recognizing the organizational structures regulating interprofessional relations in different health systems. A coherent framework for in-depth comparisons of different models for organizing interprofessional relations and the skill mix between professional groups is currently not available. This study aims to develop an ideal-typical framework for categorizing skill mix and interprofessional relations in health care, and to assess the potential impact for different ideal types on care coordination and integrated service delivery. A document analysis of the Health Systems in Transition (HiT) reports published by the European Observatory on Health Systems and Policies was conducted. The HiT reports to 31 European health systems were analyzed using a qualitative content analysis and a process of meaning condensation. The educational tracks available to nurses have an impact on the professional autonomy for nurses, the hierarchy between professional groups, the emphasis given to negotiating skill mix, interdisciplinary teamwork and the extent of cooperation across the health and social service interface. Based on the results of the document analysis, three ideal types for regulating interprofessional relations and skill mix in health care are delimited. For each ideal type, outcomes on service coordination and holistic service delivery are described. Comparisons of interprofessional relations are necessary for proactive health human resource policies. The proposed ideal-typical framework provides the means for in-depth comparisons of interprofessional relations in the health care workforce beyond of what is possible with directly comparable, but generic performance indicators.

A child chronic cough-specific quality of life measure: development and validation.

PubMed

Newcombe, Peter A; Sheffield, Jeanie K; Petsky, Helen L; Marchant, Julie M; Willis, Carol; Chang, Anne B

2016-08-01

Quality of life (QoL) measures are an important patient-relevant outcome measure for clinical studies. Cough is the most common symptom that results in new medical consultations. Although adult and parent-proxy cough-specific QoL instruments have been shown to be a useful cough outcome measure, no suitable cough-specific QoL measure for children with chronic cough exists. We report on the statistical properties of a chronic cough-specific QoL (CC-QoL) questionnaire for children. 130 children (median age 10 years, IQR 8-12 years; 65 girls) participated. A preliminary 37-item version was developed from conversations with children with chronic cough (>4 weeks). Children also completed generic QoL questionnaires (Pediatric QoL Inventory 4.0 (PedsQL4.0), Spence Children's Anxiety Scale (SCAS)) and cough diary scores. The clinical impact method of item reduction resulted in 16 items that had excellent internal consistency (Cronbach's α=0.94) among these items and also within each domain. Evidence for construct and criterion validity was established with significant correlations between CC-QoL subscales with cough scores, PedsQL and SCAS scores. CC-QoL scores were sensitive to change following an intervention and significant differences were noted between those children coughing and those who had ceased coughing. Minimum important difference (MID) for overall and domain CC-QoL ranged from 0.37-1.36 (distribution-based approach) to 1.11-1.58 (anchor-based approach). Chronic cough significantly impacts the QoL of children. The CC-QoL is a reliable, valid and sensitive to change outcome measure that assesses QoL from the child's perspective. Pending data from a confirmatory cohort, a MID for the CC-QoL of 1.1 is recommended when evaluating health status change. 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/

Generic Surface-to-Air Missile Model.

DTIC Science & Technology

1979-10-01

describes the Generic Surface-to-Air Missile Model (GENSAM) which evaluates the outcome of an engagement between a surface-to-air missile system and an...DETAILS OF THE GENERIC SAM MODEL 3-1 3.1 Coordinate Transformations 3-1 3.1.1 Coordinate Systems 3-1 3.1.2 Coordinate Transformations 3-4 3.1.3 Functions...Tracking Radars 3-54 3.3.11 Deception Jamming and Tracking Radars 3-55 3.3.12 Jaming and Track Radar Downlinks 3-56 3.3.13 Infrared Surveillance Systems 3

An investigation of prior knowledge in Automatic Music Transcription systems.

PubMed

Cazau, Dorian; Revillon, Guillaume; Krywyk, Julien; Adam, Olivier

2015-10-01

Automatic transcription of music is a long-studied research field with many operational systems available commercially. In this paper, a generic transcription system able to host various prior knowledge parameters has been developed, followed by an in-depth investigation of their impact on music transcription. Explicit links between musical knowledge and algorithmic formalism have been made. Musical knowledge covers classes of timbre, musicology, and playing style of an instrument repertoire. An evaluation sound corpus gathering musical pieces played by human performers from three different instrument repertoires, namely, classical piano, steel-string acoustic guitar, and the marovany zither from Madagascar, has been developed. The different components of musical knowledge have been successively incorporated in a complete transcription system, consisting mainly of a Probabilistic Latent Component Analysis algorithm post-processed with a Hidden Markov Model, and their impact on transcription results have been comparatively evaluated.

The psychosocial burden of human papillomavirus related disease and screening interventions.

PubMed

Pirotta, M; Ung, L; Stein, A; Conway, E L; Mast, T C; Fairley, C K; Garland, S

2009-12-01

(i) To assess the psychosocial burden of testing for human papillomavirus (HPV) related genital disease or of a HPV-related diagnosis; (ii) to compare an instrument specifically designed to measure HPV-related psychosocial burden with other generic quality of life (QoL) instruments. A cross-sectional design. Researchers recruited women from outpatient clinics at a major tertiary women's hospital and a sexual health centre who completed surveys within 3 months of receiving 331 women, 18-45 years, who had experienced a normal cervical Papanicolaou (Pap) result, an abnormal Pap result, biopsy confirmed cervical intraepithelial neoplasia (CIN) or external genital warts (EGW). The HPV impact profile (HIP) designed to assess the psychosocial impact of HPV; two general health-related QoL surveys-the EuroQoL VAS and the Sheehan disability scale; and a HPV knowledge survey. Response rate was 78%. Significant psychosocial impacts were found for women screened for, or having a diagnosis of, HPV-related genital disease. The largest impact was in women with CIN 2/3 and EGW. This HPV-related psychosocial impact was most sensitively detected with the HIP. Relative to generic measures of QoL, the HIP provided insight into the full range of psychosocial impacts of HPV testing and diagnoses. Clinicians need to be aware of the potential psychosocial impact of testing for or diagnosing HPV-related genital disease, in particular CIN 2/3 and EGW. The HIP survey is a more sensitive measure of the psychosocial impact of HPV-related genital disease than generic QoL surveys.

Medicaid prescription limits: policy trends and comparative impact on utilization.

PubMed

Lieberman, Daniel A; Polinski, Jennifer M; Choudhry, Niteesh K; Avorn, Jerry; Fischer, Michael A

2016-01-15

Medicaid programs face growing pressure to control spending. Despite evidence of clinical harms, states continue to impose policies limiting the number of reimbursable prescriptions (caps). We examined the recent use of prescription caps by Medicaid programs and the impact of policy implementation on prescription utilization. We identified Medicaid cap policies from 2001-2010. We classified caps as applying to all prescriptions (overall caps) or only branded prescriptions (brand caps). Using state-level, aggregate prescription data, we developed interrupted time-series analyses to evaluate the impact of implementing overall caps and brand caps in a subset of states with data available before and after cap initiation. For overall caps, we examined the use of essential medications, which were classified as preventive or as providing symptomatic benefit. For brand caps, we examined the use of all branded drugs as well as branded and generic medications among classes with available generic replacements. The number of states with caps increased from 12 in 2001 to 20 in 2010. Overall cap implementation (n = 3) led to a 0.52% (p < 0.001) annual decrease in the proportion of essential prescriptions but no change in cost. For preventive essential medications, overall caps led to a 1.12% (p = 0.001) annual decrease in prescriptions (246,000 prescriptions annually) and a 1.20% (p < 0.001) decrease in spending (-$12.2 million annually), but no decrease in symptomatic essential medication use. Brand cap implementation (n = 6) led to an immediate 2.29% (p = 0.16) decrease in branded prescriptions and 1.26% (p = 0.025) decrease in spending. For medication classes with generic replacements, the decrease in branded prescriptions (0.74%, p = 0.003) approximately equaled the increase in generics (0.79%, p = 0.009), with estimated savings of $17.4 million. An increasing number of states are using prescription caps, with mixed results. Overall caps decreased the use of preventive but not symptomatic essential medications, suggesting that patients assign higher priority to agents providing symptomatic benefit when faced with reimbursement limits. Among medications with generic replacements, brand caps shifted usage from branded drugs to generics, with considerable savings. Future research should analyze the patient-level impact of these policies to measure clinical outcomes associated with these changes.

The Impact of Generic Language about Ability on Children's Achievement Motivation

ERIC Educational Resources Information Center

Cimpian, Andrei

2010-01-01

Nuances in how adults talk about ability may have important consequences for children's sustained involvement and success in an activity. In this study, I tested the hypothesis that children would be less motivated while performing a novel activity if they were told that boys or girls in general are good at this activity (generic language) than if…

Pharmacists' views and reported practices in relation to a new generic drug substitution policy in Lebanon: a mixed methods study.

PubMed

El-Jardali, Fadi; Fadlallah, Racha; Morsi, Rami Z; Hemadi, Nour; Al-Gibbawi, Mounir; Haj, Magda; Khalil, Suzan; Saklawi, Youssef; Jamal, Diana; Akl, Elie A

2017-02-17

Governments in both developed and developing countries have adopted generic drug substitution policies to decrease pharmaceutical expenditures and improve access to medicine. In August 2015, the Ministry of Public Health (MOPH) in Lebanon introduced generic drug substitution and a unified medical prescription form as policy instruments to promote generic drug use. The objective of this exploratory study was to examine the attitudes of community pharmacists and the reported practices in relation to the implementation of the new generic drug substitution policy. We used a cross-sectional mixed methods approach composed of self-administered questionnaires and semi-structured interviews. The study population consisted of community pharmacists in Lebanon. We randomly approached one pharmacy personnel from each selected community pharmacy. We conducted descriptive analyses to assess responses to questionnaire and regression analyses to understand associations between responses and respondent demographics. We analyzed qualitative data thematically. Out of 204 invited community pharmacies, 153 pharmacies participated (75% response rate). The majority of respondents (64%) were in favor of generic drug substitution; however, less than half (40%) indicated they have substituted brand drugs for generic equivalents. Moreover, 57% indicated that the existing pricing system discourages them from performing generic drug substitution. Most respondents indicated that physicians are overusing the "non-substitutable" option (84%) and that there are technical problems with processing the new prescription form (78%). Less than half (47%) reported that the MOPH is performing regular audits on the forms collected by the pharmacy. While 45% of the respondents indicated that consumers have accepted most of the generic substitutions, 21% perceived the increase in generic drug dispensing to be significant. Findings suggested a potentially significant association between being informed about generic drugs and respondents' support of the policy. Suggested strategies to address implementation challenges included strengthening stewardship function of MOPH, securing full commitment of health care providers, conducting educational and awareness campaigns about generic drugs and generic drug substitution, and aligning incentive systems of the key stakeholders. The majority of community pharmacists were supportive of generic drug substitution in general but not of the current implementation of the policy in Lebanon. Findings revealed implementation challenges at the provider, patient, and system level which are hindering attainment of the policy objectives. The key lessons derived from this study can be used for continuous improvement of the policy and its implementation.

Impact of pharmacy benefit design on prescription drug utilization: a fixed effects analysis of plan sponsor data.

PubMed

Roebuck, M Christopher; Liberman, Joshua N

2009-06-01

To study the impact of various elements of pharmacy benefit design on both the absolute and relative utilization of generics, brands, retail pharmacy, and mail service. Panel data on 1,074 plan sponsors covering 21.6 million individuals over 12 calendar quarters (2005-2007). A retrospective analysis of pharmacy claims. To control for potential endogeneity, linear fixed effects models were estimated for each of six dependent variables: the generic utilization rate, the brand utilization rate, the generic dispensing rate (GDR), the retail pharmacy utilization rate, the mail service utilization rate, and the mail distribution rate. Most member cost-share variables were nonlinearly associated with changes in prescription drug utilization. Marginal effects were generally greater in magnitude for brand out-of-pocket costs than for generic out-of-pocket costs. Time dummies, as well as other pharmacy benefit design elements, also yielded significant results. Prior estimates of the effect of member cost sharing on prescription drug utilization may be biased if complex benefit designs, mail service fulfillment, and unmeasured factors such as pharmaceutical pipelines are not accounted for. Commonly cited relative utilization metrics, such as GDR, may be misleading if not examined alongside absolute prescription drug utilization.

The Need and Keys for a New Generation Network Adjustment Software

NASA Astrophysics Data System (ADS)

Colomina, I.; Blázquez, M.; Navarro, J. A.; Sastre, J.

2012-07-01

Orientation and calibration of photogrammetric and remote sensing instruments is a fundamental capacity of current mapping systems and a fundamental research topic. Neither digital remote sensing acquisition systems nor direct orientation gear, like INS and GNSS technologies, made block adjustment obsolete. On the contrary, the continuous flow of new primary data acquisition systems has challenged the capacity of the legacy block adjustment systems - in general network adjustment systems - in many aspects: extensibility, genericity, portability, large data sets capacity, metadata support and many others. In this article, we concentrate on the extensibility and genericity challenges that current and future network systems shall face. For this purpose we propose a number of software design strategies with emphasis on rigorous abstract modeling that help in achieving simplicity, genericity and extensibility together with the protection of intellectual proper rights in a flexible manner. We illustrate our suggestions with the general design approach of GENA, the generic extensible network adjustment system of GeoNumerics.

Medication persistence and the use of generic and brand-name blood pressure-lowering agents.

PubMed

Corrao, Giovanni; Soranna, Davide; La Vecchia, Carlo; Catapano, Alberico; Agabiti-Rosei, Enrico; Gensini, Gianfranco; Merlino, Luca; Mancia, Giuseppe

2014-05-01

Because of their lower cost, healthcare systems recommend physicians to prefer generic products, rather than brand-name medicaments. There is then considerable interest and debate concerning safety and effectiveness of generic products. Few studies have compared patients treated with brand-name and generic drugs for adherence to treatment, with somewhat inconsistent results. The primary objective of this study was to compare the risk of discontinuing antihypertensive drug therapy in patients treated with generic or brand-name agents. The 101,618 beneficiaries of the Healthcare system of Lombardy, Italy, aged 18 years or older who were newly treated on monotherapy with antihypertensive generic or brand-name drugs during 2008, were followed until the earliest date among those of the occurrence of treatment discontinuation to whatever antihypertensive drug therapy (outcome), or censoring (death, emigration, 12 months after treatment initiation). Hazard ratios of discontinuation associated with starting on generic or brand-name products (intention-to-treat analysis), and incidence rate ratio of discontinuation during periods on generic and brand-name products (as-treated analysis) were respectively estimated from a cohort and self-controlled case series analyses. Patients who started on generics did not experience a different risk of discontinuation compared with those starting on brand-name agents (hazard ratio: 1.00; 95% confidence interval 0.98-1.02). Discontinuation did not occur with different rates during periods covered by generics or brand-name agents (incidence rate ratio: 1.01; 95% confidence interval 0.96-1.11) within the same individuals. A number of sensitivity and subgroup analyses confirmed the robustness of these findings. Generic products are not responsible for the high rate of discontinuation from antihypertensive drug therapy. Assuming therapeutic equivalence, clinical implication is of prescribing generic drug therapies.

Parts on Demand: Evaluation of Approaches to Achieve Flexible Manufacturing Systems for Navy Partson Demand. Volume 1

DTIC Science & Technology

1984-02-01

measurable impact if changed. The following items were included in the sample: * Mark Zero Items -Low demand insurance items which represent about three...R&D efforts reviewed. The resulting assessment highlighted the generic enabling technologies and cross- cutting R&D projects required to focus current...supplied by spot buys, and which may generate Navy Inventory Control Numbers (NICN). Random samples of data were extracted from the Master Data File ( MDF

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.

A comparison of human cadaver and augmented reality simulator models for straight laparoscopic colorectal skills acquisition training.

PubMed

LeBlanc, Fabien; Champagne, Bradley J; Augestad, Knut M; Neary, Paul C; Senagore, Anthony J; Ellis, Clyde N; Delaney, Conor P

2010-08-01

The aim of this study was to compare the human cadaver model with an augmented reality simulator for straight laparoscopic colorectal skills acquisition. Thirty-five sigmoid colectomies were performed on a cadaver (n = 7) or an augmented reality simulator (n = 28) during a laparoscopic training course. Prior laparoscopic colorectal experience was assessed. Objective structured technical skills assessment forms were completed by trainers and trainees independently. Groups were compared according to technical skills and events scores and satisfaction with training model. Prior laparoscopic experience was similar in both groups. For trainers and trainees, technical skills scores were considerably better on the simulator than on the cadaver. For trainers, generic events score was also considerably better on the simulator than on the cadaver. The main generic event occurring on both models was errors in the use of retraction. The main specific event occurring on both models was bowel perforation. Global satisfaction was better for the cadaver than for the simulator model (p < 0.001). The human cadaver model was more difficult but better appreciated than the simulator for laparoscopic sigmoid colectomy training. Simulator training followed by cadaver training can appropriately integrate simulators into the learning curve and maintain the benefits of both training methodologies. Published by Elsevier Inc.

The transition to hospital consultant and the influence of preparedness, social support, and perception: A structural equation modelling approach.

PubMed

Westerman, Michiel; Teunissen, Pim W; Fokkema, Joanne P I; van der Vleuten, Cees P M; Scherpbier, Albert J J A; Siegert, Carl E H; Scheele, Fedde

2013-04-01

Insight into the transition from specialist registrar to hospital consultant is needed to better align specialty training with starting as a consultant and to facilitate this transition. This study investigates whether preparedness regarding medical and generic competencies, perceived intensity, and social support are associated with burnout among new consultants. A population-based study among all 2643 new consultants in the Netherlands (all specialties) was conducted in June 2010. A questionnaire covering preparedness for practice, intensity of the transition, social support, and burnout was used. Structural equation modelling was used for statistical analysis. Data from a third of the population were available (32% n = 840) (43% male/57% female). Preparation in generic competencies received lower ratings than in medical competencies. A total of 10% met the criteria for burnout and 18% scored high on the emotional exhaustion subscale. Perceived lack of preparation in generic competencies correlated with burnout (r = 0.15, p < 0.001). No such relation was found for medical competencies. Furthermore, social support protected against burnout. These findings illustrate the relevance of generic competencies for new hospital consultants. Furthermore, social support facilitates this intense and stressful stage within the medical career.

PubMed-supported clinical term weighting approach for improving inter-patient similarity measure in diagnosis prediction.

PubMed

Chan, Lawrence Wc; Liu, Ying; Chan, Tao; Law, Helen Kw; Wong, S C Cesar; Yeung, Andy Ph; Lo, K F; Yeung, S W; Kwok, K Y; Chan, William Yl; Lau, Thomas Yh; Shyu, Chi-Ren

2015-06-02

Similarity-based retrieval of Electronic Health Records (EHRs) from large clinical information systems provides physicians the evidence support in making diagnoses or referring examinations for the suspected cases. Clinical Terms in EHRs represent high-level conceptual information and the similarity measure established based on these terms reflects the chance of inter-patient disease co-occurrence. The assumption that clinical terms are equally relevant to a disease is unrealistic, reducing the prediction accuracy. Here we propose a term weighting approach supported by PubMed search engine to address this issue. We collected and studied 112 abdominal computed tomography imaging examination reports from four hospitals in Hong Kong. Clinical terms, which are the image findings related to hepatocellular carcinoma (HCC), were extracted from the reports. Through two systematic PubMed search methods, the generic and specific term weightings were established by estimating the conditional probabilities of clinical terms given HCC. Each report was characterized by an ontological feature vector and there were totally 6216 vector pairs. We optimized the modified direction cosine (mDC) with respect to a regularization constant embedded into the feature vector. Equal, generic and specific term weighting approaches were applied to measure the similarity of each pair and their performances for predicting inter-patient co-occurrence of HCC diagnoses were compared by using Receiver Operating Characteristics (ROC) analysis. The Areas under the curves (AUROCs) of similarity scores based on equal, generic and specific term weighting approaches were 0.735, 0.728 and 0.743 respectively (p < 0.01). In comparison with equal term weighting, the performance was significantly improved by specific term weighting (p < 0.01) but not by generic term weighting. The clinical terms "Dysplastic nodule", "nodule of liver" and "equal density (isodense) lesion" were found the top three image findings associated with HCC in PubMed. Our findings suggest that the optimized similarity measure with specific term weighting to EHRs can improve significantly the accuracy for predicting the inter-patient co-occurrence of diagnosis when compared with equal and generic term weighting approaches.

Ranking of small scale proposals for water system repair using the Rapid Impact Assessment Matrix (RIAM)

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

Shakib-Manesh, T.E.; Hirvonen, K.O.; Jalava, K.J.

2014-11-15

Environmental impacts of small scale projects are often assessed poorly, or not assessed at all. This paper examines the usability of the Rapid Impact Assessment Matrix (RIAM) as a tool to prioritize project proposals for small scale water restoration projects in relation to proposals' potential to improve the environment. The RIAM scoring system was used to assess and rank the proposals based on their environmental impacts, the costs of the projects to repair the harmful impacts, and the size of human population living around the sites. A four-member assessment group (The expert panel) gave the RIAM-scores to the proposals. Themore » assumed impacts of the studied projects at the Eastern Finland water systems were divided into the ecological and social impacts. The more detailed assessment categories of the ecological impacts in this study were impacts on landscape, natural state, and limnology. The social impact categories were impacts to recreational use of the area, fishing, industry, population, and economy. These impacts were scored according to their geographical and social significance, their magnitude of change, their character, permanence, reversibility, and cumulativeness. The RIAM method proved to be an appropriate and recommendable method for the small-scale assessment and prioritizing of project proposals. If the assessments are well documented, the RIAM can be a method for easy assessing and comparison of the various kinds of projects. In the studied project proposals there were no big surprises in the results: the best ranks were received by the projects, which were assumed to return watersheds toward their original state.« less

Comparing 15D Valuation Studies in Norway and Finland-Challenges When Combining Information from Several Valuation Tasks.

PubMed

Michel, Yvonne Anne; Augestad, Liv Ariane; Rand, Kim

2018-04-01

The 15D is a generic preference-based health-related quality-of-life instrument developed in Finland. Values for the 15D instrument are estimated by combining responses to three distinct valuation tasks. The impact of how these tasks are combined is relatively unexplored. To compare 15D valuation studies conducted in Norway and Finland in terms of scores assigned in the valuation tasks and resulting value algorithms, and to discuss the contributions of each task and the algorithm estimation procedure to observed differences. Norwegian and Finnish scores from the three valuation tasks were compared using independent samples t tests and Lin concordance correlation coefficients. Covariance between tasks was assessed using Pearson product-moment correlations. Norwegian and Finnish value algorithms were compared using concordance correlation coefficients, total ranges, and ranges for individual dimensions. Observed differences were assessed using minimal important difference. Mean scores in the main valuation task were strikingly similar between the two countries, whereas the final value algorithms were less similar. The largest differences between Norway and Finland were observed for depression, vision, and mental function. 15D algorithms are a product of combining scores from three valuation tasks by use of methods involving multiplication. This procedure used to combine scores from the three tasks by multiplication serves to amplify variance from each task. From relatively similar responses in Norway and Finland, diverging value algorithms are created. We propose to simplify the 15D algorithm estimation procedure by using only one of the valuation tasks. Copyright © 2018 International Society for Pharmacoeconomics and Outcomes Research (ISPOR). Published by Elsevier Inc. All rights reserved.

Is generic rifaximin still a poorly absorbed antibiotic? A comparison of branded and generic formulations in healthy volunteers.

PubMed

Blandizzi, Corrado; Viscomi, Giuseppe Claudio; Marzo, Antonio; Scarpignato, Carmelo

2014-07-01

Rifaximin is an antibiotic, locally acting in the gastrointestinal tract, which may exist in different crystal as well as amorphous forms. The branded rifaximin formulation contains the polymorph rifaximin-α, whose systemic bioavailability is very limited. This study was performed to compare the pharmacokinetics of this formulation with that of a generic product, whose composition in terms of solid state forms of the active pharmaceutical ingredient was found to be different. Two tablets (2×200mg) of branded and generic formulations were given to 24 healthy volunteers of either sex, according to a single-blind, randomized, two-treatment, single-dose, two-period, cross-over design. Plasma and urinary samples were collected at preset times (for 24h or 48h, respectively) after dosing, and assayed for rifaximin concentrations by high-performance liquid chromatography-mass spectrometry. Rifaximin plasma and urine concentration-time profiles showed relevant differences when generic and branded rifaximin were compared. Most pharmacokinetic parameters were significantly higher after administration of generic rifaximin than after rifaximin-α. In particular, the differences for Cmax, AUC and cumulative urinary excretion between the generic formulation and the branded product ranged from 165% to 345%. The few adverse events recorded were not serious and not related to study medications. The results of the present investigation demonstrate different systemic bioavailability of generic and branded formulations of rifaximin. As a consequence, the therapeutic results obtained with rifaximin-α should not be translated sic et simpliciter to the generic formulations of rifaximin, which do not claim containing only rifaximin-α and will display significantly higher systemic absorption in both health and disease. Copyright © 2014 Elsevier Ltd. All rights reserved.

Mathematical Modeling Of Life-Support Systems

NASA Technical Reports Server (NTRS)

Seshan, Panchalam K.; Ganapathi, Balasubramanian; Jan, Darrell L.; Ferrall, Joseph F.; Rohatgi, Naresh K.

1994-01-01

Generic hierarchical model of life-support system developed to facilitate comparisons of options in design of system. Model represents combinations of interdependent subsystems supporting microbes, plants, fish, and land animals (including humans). Generic model enables rapid configuration of variety of specific life support component models for tradeoff studies culminating in single system design. Enables rapid evaluation of effects of substituting alternate technologies and even entire groups of technologies and subsystems. Used to synthesize and analyze life-support systems ranging from relatively simple, nonregenerative units like aquariums to complex closed-loop systems aboard submarines or spacecraft. Model, called Generic Modular Flow Schematic (GMFS), coded in such chemical-process-simulation languages as Aspen Plus and expressed as three-dimensional spreadsheet.

The Framework of a Generic DProf Programme--A Reflection on Its Design, the Relational Dimension for Candidates and Advisers and the Potential for Knowledge Co-Creation

ERIC Educational Resources Information Center

Fillery-Travis, Annette Jayne

2014-01-01

This paper critically engages with the pedagogical design of a generic professional doctorate programme as a framework for creation of actionable knowledge within the practice of both adviser and candidate. Within this exploration the relational dimensions of the adviser-candidate interaction are identified and their potential impact partially…

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.

Comparative Evaluation of U.S. Brand and Generic Intravenous Sodium Ferric Gluconate Complex in Sucrose Injection: Physicochemical Characterization

PubMed Central

Sun, Dajun; Rouse, Rodney; Patel, Vikram; Wu, Yong; Zheng, Jiwen; Karmakar, Alokita; Patri, Anil K.; Keire, David; Ma, Jia; Jiang, Wenlei

2018-01-01

The objective of this study was to evaluate physicochemical equivalence between brand (i.e., Ferrlecit) and generic sodium ferric gluconate (SFG) in sucrose injection by conducting a series of comparative in vitro characterizations using advanced analytical techniques. The elemental iron and carbon content, thermal properties, viscosity, particle size, zeta potential, sedimentation coefficient, and molecular weight were determined. There was no noticeable difference between brand and generic SFG in sucrose injection for the above physical parameters evaluated, except for the sedimentation coefficient determined by sedimentation velocity analytical ultracentrifugation (SV-AUC) and molecular weight by asymmetric field flow fractionation-multi-angle light scattering (AFFF-MALS). In addition, brand and generic SFG complex products showed comparable molecular weight distributions when determined by gel permeation chromatography (GPC). The observed minor differences between brand and generic SFG, such as sedimentation coefficient, do not impact their biological activities in separate studies of in vitro cellular uptake and rat biodistribution. Coupled with the ongoing clinical study comparing the labile iron level in healthy volunteers, the FDA-funded post-market studies intended to illustrate comprehensive surveillance efforts ensuring safety and efficacy profiles of generic SFG complex in sucrose injection, and also to shed new light on the approval standards on generic parenteral iron colloidal products. PMID:29303999

Integrated Flight-propulsion Control Concepts for Supersonic Transport Airplanes

NASA Technical Reports Server (NTRS)

Burcham, Frank W., Jr.; Gilyard, Glenn B.; Gelhausen, Paul A.

1990-01-01

Integration of propulsion and flight control systems will provide significant performance improvements for supersonic transport airplanes. Increased engine thrust and reduced fuel consumption can be obtained by controlling engine stall margin as a function of flight and engine operating conditions. Improved inlet pressure recovery and decreased inlet drag can result from inlet control system integration. Using propulsion system forces and moments to augment the flight control system and airplane stability can reduce the flight control surface and tail size, weight, and drag. Special control modes may also be desirable for minimizing community noise and for emergency procedures. The overall impact of integrated controls on the takeoff gross weight for a generic high speed civil transport is presented.

ATMS concept of operations and generic system requirements : task B : final interim report for design of support systems for advanced traffic management systems

DOT National Transportation Integrated Search

1993-10-01

This document describes the Concept of Operations and Generic System Requirements for : the next generation of Traffic Management Centers (TMC). Four major steps comprise the : development of this Concept of Operations. The first step was to survey t...

A generic model for estimating biomass accumulation and greenhouse gas emissions from perennial crops

NASA Astrophysics Data System (ADS)

Ledo, Alicia; Heathcote, Richard; Hastings, Astley; Smith, Pete; Hillier, Jonathan

2017-04-01

Agriculture is essential to maintain humankind but is, at the same time, a substantial emitter of greenhouse gas (GHG) emissions. With a rising global population, the need for agriculture to provide secure food and energy supply is one of the main human challenges. At the same time, it is the only sector which has significant potential for negative emissions through the sequestration of carbon and offsetting via supply of feedstock for energy production. Perennial crops accumulate carbon during their lifetime and enhance organic soil carbon increase via root senescence and decomposition. However, inconsistency in accounting for this stored biomass undermines efforts to assess the benefits of such cropping systems when applied at scale. A consequence of this exclusion is that efforts to manage this important carbon stock are neglected. Detailed information on carbon balance is crucial to identify the main processes responsible for greenhouse gas emissions in order to develop strategic mitigation programs. Perennial crops systems represent 30% in area of total global crop systems, a considerable amount to be ignored. Furthermore, they have a major standing both in the bioenergy and global food industries. In this study, we first present a generic model to calculate the carbon balance and GHGs emissions from perennial crops, covering both food and bioenergy crops. The model is composed of two simple process-based sub-models, to cover perennial grasses and other perennial woody plants. The first is a generic individual based sub-model (IBM) covering crops in which the yield is the fruit and the plant biomass is an unharvested residue. Trees, shrubs and climbers fall into this category. The second model is a generic area based sub-model (ABM) covering perennial grasses, in which the harvested part includes some of the plant parts in which the carbon storage is accounted. Most second generation perennial bioenergy crops fall into this category. Both generic sub-models presented in this paper can be parametrized for different crops. Quantifying CO2 capture by plants and biomass accumulation and changes in soil carbon, are key in evaluating the impacts of perennial crops in life cycle analysis. We then use this model to illustrate the importance of biomass in the overall GHG estimation from four important perennial crops - sugarcane, Miscanthus, coffee, and apples - which were chosen to cover tropical and temperate regions, trees and grasses, and energy and food supply.

The utility of clinical decision tools for diagnosing osteoporosis in postmenopausal women with rheumatoid arthritis

PubMed Central

Brand, Caroline; Lowe, Adrian; Hall, Stephen

2008-01-01

Background Patients with rheumatoid arthritis have a higher risk of low bone mineral density than normal age matched populations. There is limited evidence to support cost effectiveness of population screening in rheumatoid arthritis and case finding strategies have been proposed as a means to increase cost effectiveness of diagnostic screening for osteoporosis. This study aimed to assess the performance attributes of generic and rheumatoid arthritis specific clinical decision tools for diagnosing osteoporosis in a postmenopausal population with rheumatoid arthritis who attend ambulatory specialist rheumatology clinics. Methods A cross-sectional study of 127 ambulatory post-menopausal women with rheumatoid arthritis was performed. Patients currently receiving or who had previously received bone active therapy were excluded. Eligible women underwent clinical assessment and dual-energy-xray absorptiometry (DXA) bone mineral density assessment. Clinical decision tools, including those specific for rheumatoid arthritis, were compared to seven generic post-menopausal tools to predict osteoporosis (defined as T score < -2.5). Sensitivity, specificity, positive predictive and negative predictive values and area under the curve were assessed. The diagnostic attributes of the clinical decision tools were compared by examination of the area under the receiver-operator-curve. Results One hundred and twenty seven women participated. The median age was 62 (IQR 56–71) years. Median disease duration was 108 (60–168) months. Seventy two (57%) women had no record of a previous DXA examination. Eighty (63%) women had T scores at femoral neck or lumbar spine less than -1. The area under the ROC curve for clinical decision tool prediction of T score <-2.5 varied between 0.63 and 0.76. The rheumatoid arthritis specific decision tools did not perform better than generic tools, however, the National Osteoporosis Foundation score could potentially reduce the number of unnecessary DXA tests by approximately 45% in this population. Conclusion There was limited utility of clinical decision tools for predicting osteoporosis in this patient population. Fracture prediction tools that include risk factors independent of BMD are needed. PMID:18230132

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.

JEDI Wind Models | Jobs and Economic Development Impact Models | NREL

Science.gov Websites

Wind Models JEDI Wind Models The Jobs and Economic Development Impacts (JEDI) Wind model allows the user to estimate economic development impacts from wind power generation projects. JEDI Wind has default information that can be used to run a generic impacts analysis assuming wind industry averages

75 FR 81031 - Consideration of Environmental Impacts of Temporary Storage of Spent Fuel After Cessation of...

Federal Register 2010, 2011, 2012, 2013, 2014

2010-12-23

... Part VI Nuclear Regulatory Commission 10 CFR Part 51 Consideration of Environmental Impacts of... Consideration of Environmental Impacts of Temporary Storage of Spent Fuel After Cessation of Reactor Operation... Commission (NRC or Commission) is revising its generic determination on the environmental impacts of storage...

75 FR 6066 - Extension of Public Comment Period on the Draft Environmental Impact Statement for the Nichols...

Federal Register 2010, 2011, 2012, 2013, 2014

2010-02-05

... Environmental Impact Statement for the Nichols Ranch In-Situ Recovery Project in Campbell and Johnson Counties, WY; Supplement to the Generic Environmental Impact Statement for In-Situ Leach Uranium Milling... Environmental Impact Statement (Draft SEIS) for the Nichols Ranch In- Situ Recovery (ISR) Project closes on...

Anesthetic variation and potential impact of anesthetics used during endovascular management of acute ischemic stroke.

PubMed

Sivasankar, Chitra; Stiefel, Michael; Miano, Todd A; Kositratna, Guy; Yandrawatthana, Sukanya; Hurst, Robert; Kofke, W Andrew

2016-11-01

Many authors have reported that general anesthesia (GA), as a generic and uncharacterized therapy, is contraindicated for patients undergoing endovascular management of acute ischemic stroke (EMAIS). The recent American Heart Association update cautiously suggests that it might be reasonable to favor conscious sedation over GA during EMAIS. We are concerned that such recommendations will result in patients undergoing endovascular treatment without consideration of the effects of specific anesthetic agents and anesthetic dose, and without appropriate critical consideration of the individual patient's issues. We hypothesized that significant variation in anesthetic practice comprises GA, and that outcome differences among types of GA would arise. With IRB approval, we examined the records of patients who underwent anterior circulation EMAIS at the University of Pennsylvania from 2010 to 2015. Patients were managed by different anesthesiologists with no specific protocol. We analyzed American Society of Anesthesiologists status, NIH Stroke Scale, type of stroke, procedure, different types of anesthetic, blood pressure control, and outcome metrics. Modified Rankin Scale (mRS) scores were determined from medical records. GA was used in 91% of patients. Several types of GA were employed: intravenous, volatile, and intravenous/volatile combined. mRS scores ≤2 at discharge were observed in 42.8% of patients receiving volatile anesthesia and were better in patients receiving only volatile agents after induction of anesthesia (p<0.05). Our data support the notion that anesthetic techniques and associated physiology used in EMAIS are not homogeneous, making any statements about the effects of generic GA in stroke ambiguous. Moreover, our data suggest that the type of GA may affect the outcome after EMAIS. 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/.

FDA's proposed rules on patent listing requirements for new drug and 30-month stays on ANDA approval (proposed Oct. 24, 2002).

PubMed

Hui, Yuk Fung

2003-01-01

In order to close the loophole in the generic drug approval process that allows a brand name drug patent holder to delay or defeat generic drug application merely by technicality, the FDA recently proposed to modify its regulations. Those proposals affect the patent listing requirements of a new drug application, and the duration of time that a generic drug application could be put on hold in the event of a patent infringement suit. With the modified rules, the FDA expects to see an increase in the availability of generic drugs, which eventually will lead to lower drug costs. Ms. Hui discusses the contents of the proposed regulations and provides an analysis of the proposed rule's legal authority, implications on patent rights, and impact on the pharmaceutical industry.

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.

75 FR 6068 - Extension of Public Comment Period on the Draft Environmental Impact Statement for the Lost Creek...

Federal Register 2010, 2011, 2012, 2013, 2014

2010-02-05

... Environmental Impact Statement for the Lost Creek In-Situ Recovery Project in Sweetwater County, WY; Supplement to the Generic Environmental Impact Statement for In-Situ Leach Uranium Milling Facilities AGENCY... SEIS) for the Lost Creek [[Page 6069

The economic consequences of generic substitution for antiepileptic drugs in a public payer setting: the case of lamotrigine.

PubMed

Duh, Mei Sheng; Andermann, Frederick; Paradis, Pierre Emmanuel; Weiner, Jennifer; Manjunath, Ranjani; Crémieux, Pierre-Yves

2007-08-01

Generic substitution of antiepileptic drugs (AEDs) may increase pharmacy utilization, thus counterbalancing per-pill savings. The purpose of our study was to analyze the economic impact of government-mandated switching from branded to generic lamotrigine. Patients in a Canadian public pharmacy claims database using branded lamotrigine (Lamictal GlaxoSmithKline, UK) in 2002 converted to generic lamotrigine in 2003 and were observed from July 2002 to March 2006. Patients used branded lamotrigine for >or=90 days pre-generic entry and had >or=1 claim for generic lamotrigine post-generic entry. For the generic period, observed per-patient monthly drug costs were calculated as the sum of costs for lamotrigine, other AEDs, and non-AEDs. Expected per-patient drug costs were estimated assuming lamotrigine dose and other prescription drug utilization in the generic period were identical to those observed during the brand period. Differences between observed and expected costs were compared. Among 1,142 branded lamotrigine users, overall average monthly drug costs per person were expected to decrease by $30.55 due to lower pill costs. Instead, they fell by $11.98 from the brand to the generic periods (p < 0.001). Because of dosage changes, lamotrigine costs decreased by $29.92 instead of the anticipated $33.87 (p < 0.001). Increased pharmacy utilization caused other AED costs to rise by $6.29 versus the expected $0.36 (p < 0.001), while non-AED drug cost increased by $11.64 rather than by $2.95 (p < 0.001). We concluded that conversion to generic lamotrigine resulted in lower than expected cost savings. Further research is necessary to determine whether this is due to reduced effectiveness and/or tolerability. Payers may weigh smaller-than-expected cost reductions against a possible decrease in effectiveness to assess the relevance of mandatory generic switching of lamotrigine.

Questionnaire on the awareness of generic drugs among outpatients and medical staff.

PubMed

Hoshi, S; Kimura, H

2008-06-01

Generic drugs are not as widely used in Japan as they are in the West. The objective of this study was to survey the awareness of generic drugs among outpatients and medical staff and propose methods of promoting the use of generic drugs. Our survey showed that 86.7% of respondents were aware of generic drugs. This is a higher awareness rate than that in a survey of other groups conducted last year. One reason to explain this higher awareness is the recent increase in generic drug advertisements both in newspapers and on television. However, a point of note is that generic drug usage has not increased. Our survey also showed that generic drug awareness was differed widely among age groups, as younger respondents were much more aware of generic drugs than older respondents. Still, about 40% of respondents who were aware of generic drugs did not realize that they were less expensive than name-brand drugs ? including 30% of medical staff. In addition to continuing advertisement of generic drugs in the media, medical doctors and pharmacists should also be encouraged to endorse the use of generic drugs. Furthermore a new system allowing for substitution prescriptions started in April 2008 and consequently pharmacists can now play an important role in promoting the use of generic drugs.

The effectiveness of Picture Exchange Communication System (PECS) training for teachers of children with autism: a pragmatic, group randomised controlled trial.

PubMed

Howlin, Patricia; Gordon, R Kate; Pasco, Greg; Wade, Angie; Charman, Tony

2007-05-01

To assess the effectiveness of expert training and consultancy for teachers of children with autism spectrum disorder in the use of the Picture Exchange Communication System (PECS). Group randomised, controlled trial (3 groups: immediate treatment, delayed treatment, no treatment). 84 elementary school children, mean age 6.8 years. A 2-day PECS workshop for teachers plus 6 half-day, school-based training sessions with expert consultants over 5 months. Rates of: communicative initiations, use of PECS, and speech in the classroom; Autism Diagnostic Observation Schedule-Generic (ADOS-G) domain scores for Communication and Reciprocal Social Interaction; scores on formal language tests. Controlling for baseline age, developmental quotient (DQ) and language; rates of initiations and PECS usage increased significantly immediately post-treatment (Odds Ratio (OR) of being in a higher ordinal rate category 2.72, 95% confidence interval 1.22-6.09, p < .05 and OR 3.90 (95%CI 1.75-8.68), p < .001, respectively). There were no increases in frequency of speech, or improvements in ADOS-G ratings or language test scores. The results indicate modest effectiveness of PECS teacher training/consultancy. Rates of pupils' initiations and use of symbols in the classroom increased, although there was no evidence of improvement in other areas of communication. TREATMENT effects were not maintained once active intervention ceased.

Prescription, Dispensation, and Generic Medicine Replacement Ratios: Influence on Japanese Medicine Costs

PubMed Central

Yokoi, Masayuki; Tashiro, Takao

2016-01-01

This study used publicly available data to examine the effect of the separation of dispensing and prescribing medicines between pharmacists in pharmacies and doctors in medical institutions (the separation system) and the generic medicine replacement ratio on the cost of various medicines in Japanese prefectures. For Japanese medical institutions, participation in the separation system is optional. Consequently, the expansion rate of the separation system for each administrative district is highly variable. In our multiple regression analysis, the dependent variables were the costs of daily medicines, specifically, total, internal, external, and injection medicines, as well as medical devices, and the independent variables were the expansion rate of the separation system and generic medicine replacement ratio. The expansion rate of the separation system showed a significant negative partial correlation with the daily costs of total, internal, and injection medicines as well as medical devices. Moreover, the rate of replacing brand name medicines with generic medicines showed a significant negative partial correlation with the daily costs of total and internal medicines. However, external and injection medicines and medical devices did not because only a few or no generic products of these types were sold in the Japanese market. Otherwise, expansion of the separation system was effective in reducing medicine costs, except in the case of external medicines. This suggests that the cost efficiency effect of the separation system does not function all the time. PMID:26234979

Software synthesis using generic architectures

NASA Technical Reports Server (NTRS)

Bhansali, Sanjay

1993-01-01

A framework for synthesizing software systems based on abstracting software system designs and the design process is described. The result of such an abstraction process is a generic architecture and the process knowledge for customizing the architecture. The customization process knowledge is used to assist a designer in customizing the architecture as opposed to completely automating the design of systems. Our approach using an implemented example of a generic tracking architecture which was customized in two different domains is illustrated. How the designs produced using KASE compare to the original designs of the two systems, and current work and plans for extending KASE to other application areas are described.

Disclosure of industry payments to prescribers: industry payments might be a factor impacting generic drug prescribing.

PubMed

Qian, Jingjing; Hansen, Richard A; Surry, Daniel; Howard, Jennifer; Kiptanui, Zippora; Harris, Ilene

2017-07-01

Pharmaceutical companies paid at least $3.91bn to prescribers in 2013, yet evidence indicating whether industry payments shift prescribing away from generics is limited. This study examined the association between amount of industry payments to prescribers and generic drug prescribing rates among Medicare Part D prescribers. A cross-sectional analysis was conducted among 770 095 Medicare Part D prescribers after linking the 2013 national Open Payments data with 2013 Medicare Provider Utilization and Payment data. The exposure variable was the categorized amount of total industry payments to prescribers (i.e., meals, travel, research, and ownership). The outcome was prescriber's annual generic drug prescribing rate. Multivariable generalized linear regression models were used to examine the association between the amount of industry payments and prescriber's annual generic drug prescribing rates, controlling for prescriber's demographic and practice characteristics. In this sample, over one-third (38.0%) of Medicare Part D prescribers received industry payments in 2013. The mean annual generic drug prescribing rate was highest among prescribers receiving no payments and lowest among those receiving more than $500 of industry payments (77.5% vs. 71.3%, respectively; p < 0.001). The receipt of industry payments was independently associated with prescribers' generic drug prescribing rate; higher payments corresponded with lower generic drug prescribing rates. Other prescriber characteristics associated with higher annual generic drug prescribing rate included male sex, non-northeast region, specialty, and patient volume. Receipt of industry payments was associated with a decreased rate of generic drug prescribing. How this affects patient care and total medical costs warrants further study. Copyright © 2017 John Wiley & Sons, Ltd. Copyright © 2017 John Wiley & Sons, Ltd.

Impact of alternative interventions on changes in generic dispensing rates.

PubMed

O'Malley, A James; Frank, Richard G; Kaddis, Atheer; Rothenberg, Barbara M; McNeil, Barbara J

2006-10-01

To evaluate the effectiveness of four alternative interventions (member mailings, advertising campaigns, free generic drug samples to physicians, and physician financial incentives) used by a major health insurer to encourage its members to switch to generic drugs. Using claim-level data from Blue Cross Blue Shield of Michigan, we evaluated the success of four interventions implemented during 2000-2003 designed to increase the use of generic drugs among its members. Around 13 million claims involving seven important classes of drugs were used to assess the effectiveness of the interventions. For each intervention a control group was developed that most closely resembled the corresponding intervention group. Logistic regression models with interaction effects between the treatment group (intervention versus control) and the status of the intervention (active versus not active) were used to evaluate if the interventions had an effect on the generic dispensing rate (GDR). Because the mail order pharmacy was considered more aggressive at converting prescriptions to generics, separate generic purchasing models were fitted to retail and mail order claims. In secondary analyses separate models were also fitted to claims involving a new condition and claims refilled for preexisting conditions. The interventions did not appear to increase the market penetration of generic drugs for either retail or mail order claims, or for claims involving new or preexisting conditions. In addition, we found that the ratio of copayments for brand name to generic drugs had a large positive effect on the GDR. The interventions did not appear to directly influence the GDR. Financial incentives expressed to consumers through benefit designs have a large influence on their switching to generic drugs and on the less-costly mail-order mode of purchase.

Study of a tracking and data acquisition system for the 1990's. Volume 1: User community characteristics

NASA Technical Reports Server (NTRS)

Mccreary, T.

1981-01-01

Projected 1990's experiments; navigation requirements and potentials; communications requirements associated with space experiments; alternative forecast options; and operational impacts on experiments are covered. A baseline of plans for the TDAS User Community, including a set of generic experiments developed to supplement existing planning for the 1990's time frame is generated. It includes extensive summaries of collected data, and a bibliography. The data are representative of inputs obtained from NASA planning sources through September 1981.

Problem-Based Learning as an Effective Learning Tool in Community Medicine: Initiative in a Private Medical College of a Developing Country.

PubMed

Joseph, Nitin; Rai, Sharada; Madi, Deepak; Bhat, Kamalakshi; Kotian, Shashidhar M; Kantharaju, Supriya

2016-01-01

Knowledge of community medicine is essential for health care professionals to function as efficient primary health care physicians. Medical students learning Community Medicine as a subject are expected to be competent in critical thinking and generic skills so as to analyze community health problems better. However, current teaching by didactic lectures fails to develop these essential skills. Problem-based learning (PBL) could be an effective strategy in this respect. This study was hence done to compare the academic performance of students who were taught Community Medicine by the PBL method with that of students taught by traditional methods, to assess the generic skills of students taught in a PBL environment and to assess the perception of students toward PBL methodology. This study was conducted among seventh-semester final-year medical students between June and November 2014. PBL was introduced to a randomly chosen group of students, and their performance in an assessment exam at the end of postings was compared with that of the remaining students. Generic skills and perception toward PBL were also assessed using standardized questionnaires. A total of 77 students took part in the brainstorming session of PBL. The correlation between self-assigned scores of the participants and those assigned by the tutor in the brainstorming session of PBL was significant (r = 0.266, P = 0.05). Out of 54 students who took part in the presentation session, almost all 53 (98.1%) had good perception toward PBL. Demotivational scores were found to be significantly higher among males (P = 0.024). The academic performance of students (P < 0.001) and success rates (P = 0.05) in the examination were higher among students who took part in PBL compared to controls. PBL helped improve knowledge of students in comparison to those exposed only to didactic lectures. As PBL enabled students to identify the gaps in their knowledge and enhanced their group functioning and generic skills, we recommend PBL sessions: They would help optimize the training in Community Medicine at medical schools. Good correlation of tutor and self-assessment scores of participants in the brainstorming session suggests that the role of tutors could be restricted to assessment in presentation sessions alone. Demotivation, which hinders group performance in PBL, needs to be corrected by counselling and timely feedback by the tutors.

Influenza symptoms and their impact on elderly adults: randomised trial of AS03-adjuvanted or non-adjuvanted inactivated trivalent seasonal influenza vaccines

PubMed Central

van Essen, Gerrit A; Beran, Jiri; Devaster, Jeanne-Marie; Durand, Christelle; Duval, Xavier; Esen, Meral; Falsey, Ann R; Feldman, Gregory; Gervais, Pierre; Innis, Bruce L; Kovac, Martina; Launay, Odile; Leroux-Roels, Geert; McElhaney, Janet E; McNeil, Shelly; Oujaa, Mohammed; Richardus, Jan Hendrik; Ruiz-Palacios, Guillermo; Osborne, Richard H; Oostvogels, Lidia

2014-01-01

Background Patient-reported outcomes (PROs) are particularly relevant in influenza vaccine trials in the elderly where reduction in symptom severity could prevent illness-related functional impairment. Objectives To evaluate PROs in people aged ≥65 years receiving two different vaccines. Methods This was a phase III, randomised, observer-blind study (NCT00753272) of the AS03-adjuvanted inactivated trivalent split-virion influenza vaccine (AS03-TIV) versus non-adjuvanted vaccine (TIV). Using the FluiiQ questionnaire, symptom (systemic, respiratory, total) and life impact (activities, emotions, relationships) scores were computed as exploratory endpoints, with minimal important difference (MID) in influenza severity between vaccines considered post-hoc as >7%. Vaccine efficacy of AS03-TIV relative to TIV in severe influenza (hospitalisation, complication, most severe one-third of episodes based on the area under the curve for systemic symptom score) was calculated post-hoc. The main analyses (descriptive) were conducted in the according-to-protocol cohort (n = 280 AS03-TIV, n = 315 TIV) for influenza confirmed by culture or reverse transcriptase polymerase chain reaction. Results Mean systemic symptom, total symptom and impact on activities scores were lower with AS03-TIV versus TIV. Mean respiratory symptom, impact on emotions and impact on relationships scores were similar. Influenza tended to be less severe with AS03-TIV, but the MID was reached only for impact on activities (mean 9·0%). Relative vaccine efficacy in severe influenza was 29·38% (95% CI: 7·60–46·02). Conclusions AS03-TIV had advantages over TIV in impact on systemic symptoms and activities as measured by the FluiiQ in elderly people. Higher efficacy of AS03-TIV relative to TIV was shown for prevention of severe illness. PMID:24702710

Validity of the Spanish 8-item short-form generic health-related quality-of-life questionnaire in surgical patients: a population-based study.

PubMed

Vallès, Jordi; Guilera, Magda; Briones, Zahara; Gomar, Carmen; Canet, Jaume; Alonso, Jordi

2010-05-01

Health-related quality of life is usually reported for specific rather than heterogeneous populations such as those treated in routine anesthesia practice. The 8-item short-form generic health-related quality-of-life questionnaire (SF-8) is a candidate instrument for this setting. The authors evaluated the feasibility, reliability, validity, and responsiveness to change of the Spanish version of SF-8 in a population-based surgical cohort. Recruiting patients from a large population-based study of risk factors for pulmonary complications, before surgery, the authors administered the 1-week recall SF-8 to 2,991 patients undergoing nonobstetric elective or emergency surgery in 59 hospitals, each of which collected data on seven randomly assigned days in 2006. The SF-8 was administered again 3 months later. Reliability was evaluated using the Cronbach alpha coefficient and validity by comparing physical and mental component summary SF-8 scores with clinical variables. Responsiveness after surgery was evaluated using the standardized response mean. Cronbach alpha for the overall test was 0.92. Physical and mental component summary scores and all individual scores were lower (worse quality of life) in women (P < 0. 01) and decreased with age (P < 0.01). Preoperative scores were lower for those in worse clinical condition (higher body mass index, American Society of Anesthesiologists physical status class, or surgical risk scores), with preoperative respiratory symptoms, and in emergency situations (P < 0.01). The standardized response mean ranged from 0.1 to 0.5. The SF-8 is a feasible, reliable, valid, and responsive instrument for assessing health-related quality of life in a broad-spectrum surgical population.

Mapping CHU9D Utility Scores from the PedsQLTM 4.0 SF-15.

PubMed

Mpundu-Kaambwa, Christine; Chen, Gang; Russo, Remo; Stevens, Katherine; Petersen, Karin Dam; Ratcliffe, Julie

2017-04-01

The Pediatric Quality of Life Inventory™ 4.0 Short Form 15 Generic Core Scales (hereafter the PedsQL) and the Child Health Utility-9 Dimensions (CHU9D) are two generic instruments designed to measure health-related quality of life in children and adolescents in the general population and paediatric patient groups living with specific health conditions. Although the PedsQL is widely used among paediatric patient populations, presently it is not possible to directly use the scores from the instrument to calculate quality-adjusted life-years (QALYs) for application in economic evaluation because it produces summary scores which are not preference-based. This paper examines different econometric mapping techniques for estimating CHU9D utility scores from the PedsQL for the purpose of calculating QALYs for cost-utility analysis. The PedsQL and the CHU9D were completed by a community sample of 755 Australian adolescents aged 15-17 years. Seven regression models were estimated: ordinary least squares estimator, generalised linear model, robust MM estimator, multivariate factorial polynomial estimator, beta-binomial estimator, finite mixture model and multinomial logistic model. The mean absolute error (MAE) and the mean squared error (MSE) were used to assess predictive ability of the models. The MM estimator with stepwise-selected PedsQL dimension scores as explanatory variables had the best predictive accuracy using MAE and the equivalent beta-binomial model had the best predictive accuracy using MSE. Our mapping algorithm facilitates the estimation of health-state utilities for use within economic evaluations where only PedsQL data is available and is suitable for use in community-based adolescents aged 15-17 years. Applicability of the algorithm in younger populations should be assessed in further research.

The impact of drug samples on prescribing to the uninsured.

PubMed

Miller, David P; Mansfield, Richard J; Woods, Jonathan B; Wofford, James L; Moran, William P

2008-09-01

To determine whether drug samples are associated with physicians prescribing fewer generic, less costly medications. We conducted a retrospective study at a large university-affiliated internal medicine practice containing over 70 physicians. Using a pharmacy database, we identified all prescriptions written to uninsured or Medicaid patients that belonged to one of four classes of chronic medications. For the 9 months before and after the clinic closed its drug sample closet, we calculated the percentage of medications prescribed as generics and the mean cost of a 30-day supply of a prescription. Of 8911 prescriptions, 1973 met inclusion criteria. For uninsured patients, the percentage of medications prescribed as generics rose from 12% to 30% after the clinic closed its drug sample closet (P = 0.004). By consecutive three month periods, the percentage of prescribed generic medications rose steadily to a maximum of 40% (P < 0.001). For Medicaid patients, there was no significant change in generic prescribing (63% generic with samples versus 65% generic without samples, P = 0.42). Two factors were associated with generic prescribing in logistic regression: the absence of drug samples (OR 4.54, 95% CI 1.37-15.0) and the prescriber being an attending physician (OR 5.26, 95% CI 2.24-12.4). There was no statistically significant change in cost for either group. Physicians were three times more likely to prescribe generic medications to uninsured patients after drug samples were removed from the office. Drug samples may paradoxically lead to higher costs if physicians with access to samples prescribe more brand-name only drugs.

Are stormwater pollution impacts significant in life cycle assessment? A new methodology for quantifying embedded urban stormwater impacts.

PubMed

Phillips, Robert; Jeswani, Harish Kumar; Azapagic, Adisa; Apul, Defne

2018-09-15

Current life cycle assessment (LCA) models do not explicitly incorporate the impacts from urban stormwater pollution. To address this issue, a framework to estimate the impacts from urban stormwater pollution over the lifetime of a system has been developed, laying the groundwork for subsequent improvements in life cycle databases and LCA modelling. The proposed framework incorporates urban stormwater event mean concentration (EMC) data into existing LCA impact categories to account for the environmental impacts associated with urban land occupation across the whole life cycle of a system. It consists of five steps: (1) compilation of inventory of urban stormwater pollutants; (2) collection of precipitation data; (3) classification and characterisation within existing midpoint impact categories; (4) collation of inventory data for impermeable urban land occupation; and (5) impact assessment. The framework is generic and can be applied to any system using any LCA impact method. Its application is demonstrated by two illustrative case studies: electricity generation and production of construction materials. The results show that pollutants in urban stormwater have an influence on human toxicity, freshwater and marine ecotoxicity, marine eutrophication, freshwater eutrophication and terrestrial ecotoxicity. Among these, urban stormwater pollution has the highest relative contribution to the eutrophication potentials. The results also suggest that stormwater pollution from urban areas can have a substantial effect on the life cycle impacts of some systems (construction materials), while for some systems the effect is small (e.g. electricity generation). However, it is not possible to determine a priori which systems are affected so that the impacts from stormwater pollution should be considered routinely in future LCA studies. The paper also proposes ways to incorporate stormwater pollution burdens into the life cycle databases. Copyright © 2018 Elsevier B.V. All rights reserved.

Optimal Weighting for Exam Composition

ERIC Educational Resources Information Center

Ganzfried, Sam; Yusuf, Farzana

2018-01-01

A problem faced by many instructors is that of designing exams that accurately assess the abilities of the students. Typically, these exams are prepared several days in advance, and generic question scores are used based on rough approximation of the question difficulty and length. For example, for a recent class taught by the author, there were…

Health-related quality of life measurement in women with polycystic ovary syndrome: a systematic review.

PubMed

Jones, G L; Hall, J M; Balen, A H; Ledger, W L

2008-01-01

The symptoms typically associated with polycystic ovary syndrome (PCOS) such as acne, hirsutism, irregular menses, amenorrhoea, obesity and subfertility are a major source of psychological morbidity and can negatively affect quality of life (QoL). We systematically searched the literature to identify the impact of symptoms and treatments for PCOS on health-related QoL (HRQoL) and to report on the types and psychometric properties of the instruments used. Papers were retrieved by systematically searching four electronic databases and hand searching relevant reference lists and bibliographies. Nineteen papers used a standardized questionnaire to measure health status; of these 12 (63.2%) used generic tools and 8 (42%) used the disease-specific PCOS questionnaire. Although a meta-analysis was not possible, it appears that weight concerns have a particular negative impact upon HRQoL, although the role of body mass index in affecting HRQoL scores is inconclusive from the available evidence. Acne is the area least reported upon in terms of its impact upon HRQoL. With the exception of three studies, most of the research has focused upon adult women with PCOS. Despite the benefits of HRQoL measures in research, few are being used to evaluate the outcomes of treatment for PCOS upon the subjective health status of women with the condition.

A Review of Generic Program Visualization Systems for Introductory Programming Education

ERIC Educational Resources Information Center

Sorva, Juha; Karavirta, Ville; Malmi, Lauri

2013-01-01

This article is a survey of program visualization systems intended for teaching beginners about the runtime behavior of computer programs. Our focus is on generic systems that are capable of illustrating many kinds of programs and behaviors. We inclusively describe such systems from the last three decades and review findings from their empirical…

Concept for a Satellite-Based Advanced Air Traffic Management System : Volume 8. Operational Logic Flow Diagrams for a Generic Advanced Air Traffic Management system

DOT National Transportation Integrated Search

1974-02-01

The volume presents a description of the services a generic Advanced Air Traffic Management System (AATMS) should provide to the useres of the system to facilitate the safe, efficient flow of traffic. It provides a definition of the functions which t...

The Canadian National EMS Research Agenda: Impact and Feasibility of Implementation of Previously Generated Recommendations.

PubMed

Jensen, J L; Blanchard, I E; Bigham, B L; Carter, Aje; Brown, R; Socha, D; Brown, L H; Travers, A H; Craig, A M; Morrison, L J

2015-09-01

A recent mixed-methods study on the state of emergency medical services (EMS) research in Canada led to the generation of nineteen actionable recommendations. As part of the dissemination plan, a survey was distributed to EMS stakeholders to determine the anticipated impact and feasibility of implementing these recommendations in Canadian systems. An online survey explored both the implementation impact and feasibility for each recommendation using a five-point scale. The sample consisted of participants from the Canadian National EMS Research Agenda study (published in 2013) and additional EMS research stakeholders identified through snowball sampling. Responses were analysed descriptively using median and plotted on a matrix. Participants reported any planned or ongoing initiatives related to the recommendations, and required or anticipated resources. Free text responses were analysed with simple content analysis, collated by recommendation. The survey was sent to 131 people, 94 (71.8%) of whom responded: 30 EMS managers/regulators (31.9%), 22 researchers (23.4%), 15 physicians (16.0%), 13 educators (13.8%), and 5 EMS providers (5.3%). Two recommendations (11%) had a median impact score of 4 (of 5) and feasibility score of 4 (of 5). Eight recommendations (42%) had an impact score of 5, with a feasibility score of 3. Nine recommendations (47%) had an impact score of 4 and a feasibility score of 3. For most recommendations, participants scored the anticipated impact higher than the feasibility to implement. Ongoing or planned initiatives exist pertaining to all recommendations except one. All of the recommendations will require additional resources to implement.

Back from the Future: The Impact of Change on Airpower in the Decades Ahead

DTIC Science & Technology

2009-01-01

generic/story_generic.jsp?channel= awst &id=news/aw021108p2.xml&headline=Fate%20of%20F -22,%20C-17%20Lines%20Uncertain%20in%20Fiscal%202009; Pierre Sprey...second lot of low-rate initial production aircraft was announced on 22 May 2008 as $2.2 billion for 12 aircraft, and Maj Gen Charles R . Davis, USAF, the

Generic learning skills in academically-at-risk medical students: a development programme bridges the gap.

PubMed

Burch, Vanessa C; Sikakana, Cynthia N T; Gunston, Geney D; Shamley, Delva R; Murdoch-Eaton, Deborah

2013-08-01

Widening access to medical students from diverse educational backgrounds is a global educational mandate. The impact, on students' generic learning skills profiles, of development programmes designed for students at risk of attrition is unknown. This study investigated the impact of a 12-month Intervention Programme (IP) on the generic learning skills profile of academically-at-risk students who, after failing at the end of the first semester, completed the IP before entering the second semester of a conventional medical training programme. This prospective study surveyed medical students admitted in 2009 and 2010, on entry and on completion of first year, on their reported practice and confidence in information handling, managing own learning, technical and numeracy, computer, organisational and presentation skills. Of 414 first year students, 80 (19%) entered the IP. Levels of practice and confidence for five of the six skills categories were significantly poorer at entry for IP students compared to conventional stream students. In four categories these differences were no longer statistically significant after students had completed the IP; 62 IP students (77.5%) progressed to second year. A 12-month development programme, the IP, effectively addressed generic learning skills deficiencies present in academically-at-risk students entering medical school.

77 FR 70486 - Supplemental Environmental Impact Statement for Proposed Dewey-Burdock In-Situ Uranium Recovery...

Federal Register 2010, 2011, 2012, 2013, 2014

2012-11-26

... Proposed Dewey- Burdock In-Situ Uranium Recovery Project in Custer and Fall River Counties, SD AGENCY... draft Supplemental Environmental Impact Statement (Draft SEIS) for the Dewey-Burdock In-Situ Uranium... NUREG-1910, ``Generic Environmental Impact Statement for In-Situ Leach Uranium Milling Facilities,'' May...

Transactions in domain-specific information systems

NASA Astrophysics Data System (ADS)

Zacek, Jaroslav

2017-07-01

Substantial number of the current information system (IS) implementations is based on transaction approach. In addition, most of the implementations are domain-specific (e.g. accounting IS, resource planning IS). Therefore, we have to have a generic transaction model to build and verify domain-specific IS. The paper proposes a new transaction model for domain-specific ontologies. This model is based on value oriented business process modelling technique. The transaction model is formalized by the Petri Net theory. First part of the paper presents common business processes and analyses related to business process modeling. Second part defines the transactional model delimited by REA enterprise ontology paradigm and introduces states of the generic transaction model. The generic model proposal is defined and visualized by the Petri Net modelling tool. Third part shows application of the generic transaction model. Last part of the paper concludes results and discusses a practical usability of the generic transaction model.

DoD Electronic Data Interchange (EDI) Convention: ASC X12 Transaction Set 859 Generic Freight Invoice (Version 003020)

DTIC Science & Technology

1993-04-01

FREIGHT INVOICE (VERSION 003020) FORMATTING INVOICE INFORMATION FOR THE DoD TRANSPORTATION PAYMENT SYSTEM USING THE X1 2.55 TRANSACTION SET 859 GENERIC...GBYERIC FREIGHT NIVOICE EDI CONVENTON 859.003020 * Contents FORMATTING INVOICE INFORMATION FOR THE DoD TRANSPORTATION PAYMENT SYSTEM USING THE Xl 2.55... transportation invoice using the ASC X12.55 Transaction Set 859 Generic Freight Invoice (003020). It contains information for the design of interface

CETA and pharmaceuticals: impact of the trade agreement between Europe and Canada on the costs of prescription drugs.

PubMed

Lexchin, Joel; Gagnon, Marc-André

2014-05-06

On a per capita basis, Canadian drug costs are already the second highest in the world after the United States and are among the fastest rising in the Organization for Economic Co-Operation and Development. The Comprehensive Economic and Trade Agreement (CETA) between the European Union (EU) and Canada will further exacerbate the rise in costs by:  Committing Canada to creating a new system of patent term restoration thereby delaying entry of generic medicines by up to two years; Locking in Canada's current term of data protection, and creating barriers for future governments wanting to reverse it;  Implementing a new right of appeal under the patent linkage system that will create further delays for the entry of generics.CETA will only affect intellectual property rights in Canada-not the EU. This analysis estimates that CETA's provisions will increase Canadian drug costs by between 6.2% and 12.9% starting in 2023. The Canadian government committed to compensating provinces for the rise in costs for their public drug plans. Importantly, this means that people paying out-of-pocket for their drugs or receiving them through private insurance, will be charged twice: once through higher drug costs and once more through their federal taxes.As drug costs continue to grow, there are limited options available for provincial/territorial governments: restrict the choice of medicines in public drug plans; transfer costs to patients who typically are either elderly or sick; or take money from other places in the health system, and threaten the viability of Canada's single payer system. CETA will therefore negatively impact the ability of Canada to offer quality health care.

Active and passive surveillance of enoxaparin generics: a case study relevant to biosimilars.

PubMed

Grampp, Gustavo; Bonafede, Machaon; Felix, Thomas; Li, Edward; Malecki, Michael; Sprafka, J Michael

2015-03-01

This retrospective analysis assessed the capability of active and passive safety surveillance systems to track product-specific safety events in the USA for branded and generic enoxaparin, a complex injectable subject to immune-related and other adverse events (AEs). Analysis of heparin-induced thrombocytopenia (HIT) incidence was performed on benefit claims for commercial and Medicare supplemental-insured individuals newly treated with enoxaparin under pharmacy benefit (1 January 2009 - 30 June 2012). Additionally, spontaneous reports from the FDA AE Reporting System were reviewed to identify incidence and attribution of enoxaparin-related reports to specific manufacturers. Specific, dispensed products were identifiable from National Drug Codes only in pharmacy-benefit databases, permitting sensitive comparison of HIT incidence in nearly a third of patients treated with brand or generic enoxaparin. After originator medicine's loss of exclusivity, only 5% of spontaneous reports were processed by generic manufacturers; reports attributable to specific generics were approximately ninefold lower than expected based on market share. Claims data were useful for active surveillance of enoxaparin generics dispensed under pharmacy benefits but not for products administered under medical benefits. These findings suggest that the current spontaneous reporting system will not distinguish product-specific safety signals for products distributed by multiple manufacturers, including biosimilars.

Searching for gravitational waves from compact binaries with precessing spins

NASA Astrophysics Data System (ADS)

Harry, Ian; Privitera, Stephen; Bohé, Alejandro; Buonanno, Alessandra

2016-07-01

Current searches for gravitational waves from compact-object binaries with the LIGO and Virgo observatories employ waveform models with spins aligned (or antialigned) with the orbital angular momentum. Here, we derive a new statistic to search for compact objects carrying generic (precessing) spins. Applying this statistic, we construct banks of both aligned- and generic-spin templates for binary black holes and neutron star-black hole binaries, and compare the effectualness of these banks towards simulated populations of generic-spin systems. We then use these banks in a pipeline analysis of Gaussian noise to measure the increase in background incurred by using generic- instead of aligned-spin banks. Although the generic-spin banks have roughly a factor of ten more templates than the aligned-spin banks, we find an overall improvement in signal recovery at a fixed false-alarm rate for systems with high-mass ratio and highly precessing spins. This gain in sensitivity comes at a small loss of sensitivity (≲4 %) for systems that are already well covered by aligned-spin templates. Since the observation of even a single binary merger with misaligned spins could provide unique astrophysical insights into the formation of these sources, we recommend that the method described here be developed further to mount a viable search for generic-spin binary mergers in LIGO/Virgo data.

The crisis in access to essential medicines in India: key issues which call for action.

PubMed

Bhargava, Anurag; Kalantri, S P

2013-01-01

The government is planning to introduce free generic and essential medicines in public health facilities. Most people in India buy healthcare from the private sector, a compulsion that accounts for a high proportion of healthcare-related expenditure. To reduce the burden of healthcare costs, the government must improve availability and affordability of generic and essential medicines in the market. It can do so because India's large pharmaceutical industry is a major source of generic medicines worldwide. In this article, we discuss three factors that have impeded access to generic and essential medicines: (1) mistaken notions among policymakers, prescribers and patients about branded drugs and generic drugs in India; (2) high prices of medicines due to the progressive dismantling of the system of regulation of medicine prices, and (3) a drug approval and regulatory system that allows medicines (including fixed dose combinations) of doubtful efficacy, rationale, safety and public health relevance to dominate the market at the cost of access to affordable generic and essential medicines. The consequences of ill-health and wasted expenditure on drugs raise issues of public health ethics.Improving access to essential medicines in India is an urgent public health and ethical imperative. This should include improved public provisioning, a system of regulation of drug prices, and an evidence-based drug approval process.

Impact of IRT item misfit on score estimates and severity classifications: an examination of PROMIS depression and pain interference item banks.

PubMed

Zhao, Yue

2017-03-01

In patient-reported outcome research that utilizes item response theory (IRT), using statistical significance tests to detect misfit is usually the focus of IRT model-data fit evaluations. However, such evaluations rarely address the impact/consequence of using misfitting items on the intended clinical applications. This study was designed to evaluate the impact of IRT item misfit on score estimates and severity classifications and to demonstrate a recommended process of model-fit evaluation. Using secondary data sources collected from the Patient-Reported Outcome Measurement Information System (PROMIS) wave 1 testing phase, analyses were conducted based on PROMIS depression (28 items; 782 cases) and pain interference (41 items; 845 cases) item banks. The identification of misfitting items was assessed using Orlando and Thissen's summed-score item-fit statistics and graphical displays. The impact of misfit was evaluated according to the agreement of both IRT-derived T-scores and severity classifications between inclusion and exclusion of misfitting items. The examination of the presence and impact of misfit suggested that item misfit had a negligible impact on the T-score estimates and severity classifications with the general population sample in the PROMIS depression and pain interference item banks, implying that the impact of item misfit was insignificant. Findings support the T-score estimates in the two item banks as robust against item misfit at both the group and individual levels and add confidence to the use of T-scores for severity diagnosis in the studied sample. Recommendations on approaches for identifying item misfit (statistical significance) and assessing the misfit impact (practical significance) are given.

Visuospatial and psychomotor aptitude predicts endovascular performance of inexperienced individuals on a virtual reality simulator.

PubMed

Van Herzeele, Isabelle; O'Donoghue, Kevin G L; Aggarwal, Rajesh; Vermassen, Frank; Darzi, Ara; Cheshire, Nicholas J W

2010-04-01

This study evaluated virtual reality (VR) simulation for endovascular training of medical students to determine whether innate perceptual, visuospatial, and psychomotor aptitude (VSA) can predict initial and plateau phase of technical endovascular skills acquisition. Twenty medical students received didactic and endovascular training on a commercially available VR simulator. Each student treated a series of 10 identical noncomplex renal artery stenoses endovascularly. The simulator recorded performance data instantly and objectively. An experienced interventionalist rated the performance at the initial and final sessions using generic (out of 40) and procedure-specific (out of 30) rating scales. VSA were tested with fine motor dexterity (FMD, Perdue Pegboard), psychomotor ability (minimally invasive virtual reality surgical trainer [MIST-VR]), image recall (Rey-Osterrieth), and organizational aptitude (map-planning). VSA performance scores were correlated with the assessment parameters of endovascular skills at commencement and completion of training. Medical students exhibited statistically significant learning curves from the initial to the plateau performance for contrast usage (medians, 28 vs 17 mL, P < .001), total procedure time (2120 vs 867 seconds, P < .001), and fluoroscopy time (993 vs. 507 seconds, P < .001). Scores on generic and procedure-specific rating scales improved significantly (10 vs 25, P < .001; 8 vs 17 P < .001). Significant correlations were noted for FMD with initial and plateau sessions for fluoroscopy time (r(s) = -0.564, P = .010; r(s) = -.449, P = .047). FMD correlated with procedure-specific scores at the initial session (r(s) = .607, P = .006). Image recall correlated with generic skills at the end of training (r(s) = .587, P = .006). Simulator-based training in endovascular skills improved performance in medical students. There were significant correlations between initial endovascular skill and fine motor dexterity as well as with image recall at end of the training period. In addition to current recruitment strategies, VSA may be a useful tool for predictive validity studies.

Implementing the space shuttle data processing system with the space generic open avionics architecture

NASA Technical Reports Server (NTRS)

Wray, Richard B.; Stovall, John R.

1993-01-01

This paper presents an overview of the application of the Space Generic Open Avionics Architecture (SGOAA) to the Space Shuttle Data Processing System (DPS) architecture design. This application has been performed to validate the SGOAA, and its potential use in flight critical systems. The paper summarizes key elements of the Space Shuttle avionics architecture, data processing system requirements and software architecture as currently implemented. It then summarizes the SGOAA architecture and describes a tailoring of the SGOAA to the Space Shuttle. The SGOAA consists of a generic system architecture for the entities in spacecraft avionics, a generic processing external and internal hardware architecture, a six class model of interfaces and functional subsystem architectures for data services and operations control capabilities. It has been proposed as an avionics architecture standard with the National Aeronautics and Space Administration (NASA), through its Strategic Avionics Technology Working Group, and is being considered by the Society of Aeronautic Engineers (SAE) as an SAE Avionics Standard. This architecture was developed for the Flight Data Systems Division of JSC by the Lockheed Engineering and Sciences Company, Houston, Texas.

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

Study of generic quality of life in patients operated on for post-prostatectomy incontinence.

PubMed

Holm, Henriette Veiby; Fosså, Sophie D; Hedlund, Hans; Dahl, Alv A

2013-09-01

The relationship between urological and psychosocial variables, and generic quality of life in patients operated on for post-prostatectomy incontinence has hardly been studied, and our aim was to investigate this relationship. Patients who had an artificial urinary sphincter AMS800 (n = 100) implanted between January 2002 and June 2010 were invited to complete a mailed questionnaire covering demographic data including work ability, urinary and sexual function, anxiety/depression, and generic quality of life. Poor quality of life was defined as a score <40 on either the physical or the mental Short Form 12 summary scales. Of 85 compliant patients, 30 (35%) reported poor generic quality of life and 55 (65%) reported better quality of life at a median follow-up time of 26 months (range 6-104 months). The poor quality of life group showed significantly more overall urinary and sexual problems, and more men had undergone surgical revisions compared with the better quality of life group. Levels of anxiety and depression were significantly higher, and work ability was lower in the poor quality of life group. In multivariate logistic regression models, increased level of depression and impaired work ability, inability to reach orgasm, and not recommending the operation remained significantly associated with poor quality of life. Poor generic quality of life after surgery for post-prostatectomy incontinence is more strongly associated with reduced work ability and depression rather than urinary and sexual problems. © 2013 The Japanese Urological Association.

Estimating severity of sideways fall using a generic multi linear regression model based on kinematic input variables.

PubMed

van der Zijden, A M; Groen, B E; Tanck, E; Nienhuis, B; Verdonschot, N; Weerdesteyn, V

2017-03-21

Many research groups have studied fall impact mechanics to understand how fall severity can be reduced to prevent hip fractures. Yet, direct impact force measurements with force plates are restricted to a very limited repertoire of experimental falls. The purpose of this study was to develop a generic model for estimating hip impact forces (i.e. fall severity) in in vivo sideways falls without the use of force plates. Twelve experienced judokas performed sideways Martial Arts (MA) and Block ('natural') falls on a force plate, both with and without a mat on top. Data were analyzed to determine the hip impact force and to derive 11 selected (subject-specific and kinematic) variables. Falls from kneeling height were used to perform a stepwise regression procedure to assess the effects of these input variables and build the model. The final model includes four input variables, involving one subject-specific measure and three kinematic variables: maximum upper body deceleration, body mass, shoulder angle at the instant of 'maximum impact' and maximum hip deceleration. The results showed that estimated and measured hip impact forces were linearly related (explained variances ranging from 46 to 63%). Hip impact forces of MA falls onto the mat from a standing position (3650±916N) estimated by the final model were comparable with measured values (3698±689N), even though these data were not used for training the model. In conclusion, a generic linear regression model was developed that enables the assessment of fall severity through kinematic measures of sideways falls, without using force plates. Copyright © 2017 Elsevier Ltd. All rights reserved.

Evaluation of a daily practice composite score for the assessment of Crohn's disease: the treatment impact of certolizumab pegol.

PubMed

Feagan, B G; Hanauer, S B; Coteur, G; Schreiber, S

2011-05-01

Successful treatment of systemic inflammatory symptoms is essential for improving health-related quality of life in patients with active Crohn's disease. Patient-reported outcomes provide unique perspectives on the impact of chronic disease. It is unknown whether a combination of different instruments might improve sensitivity to clinically relevant changes in health status. To develop a composite score based upon Crohn's Disease Activity Index (CDAI) and Inflammatory Bowel Disease Questionnaire (IBDQ) items. Patients from the PRECiSE 2 trial who responded at week 6 to certolizumab pegol (CZP) were randomised to receive treatment with CZP 400 mg or placebo for up to 26 weeks. IBDQ and CDAI scores were assessed at weeks 0, 6, 16 and 26. A 'daily practice' composite score (DP-6) containing two items from the CDAI and four items from IBDQ was constructed. Correlation coefficients between the CDAI score and IBDQ total score at baseline and at week 26 were -0.344 and -0.603, respectively (P<0.05). All IBDQ items were improved following CZP treatment. The DP-6 had the highest responsiveness at assessing response to treatment, relative to CDAI total score, when compared with other scores. The DP-6 composite score could be used to optimise the use of existing instruments by serving as an index of symptoms due to systemic inflammation. Additional studies are needed to determine if the DP-6 composite score differentiates the impact of different treatments on patient-reported outcomes, and to determine if the use of the DP-6 improves the care of patients in clinical practice. © 2011 Blackwell Publishing Ltd.

Driver compliance to take-over requests with different auditory outputs in conditional automation.

PubMed

Forster, Yannick; Naujoks, Frederik; Neukum, Alexandra; Huestegge, Lynn

2017-12-01

Conditionally automated driving (CAD) systems are expected to improve traffic safety. Whenever the CAD system exceeds its limit of operation, designers of the system need to ensure a safe and timely enough transition from automated to manual mode. An existing visual Human-Machine Interface (HMI) was supplemented by different auditory outputs. The present work compares the effects of different auditory outputs in form of (1) a generic warning tone and (2) additional semantic speech output on driver behavior for the announcement of an upcoming take-over request (TOR). We expect the information carried by means of speech output to lead to faster reactions and better subjective evaluations by the drivers compared to generic auditory output. To test this assumption, N=17 drivers completed two simulator drives, once with a generic warning tone ('Generic') and once with additional speech output ('Speech+generic'), while they were working on a non-driving related task (NDRT; i.e., reading a magazine). Each drive incorporated one transition from automated to manual mode when yellow secondary lanes emerged. Different reaction time measures, relevant for the take-over process, were assessed. Furthermore, drivers evaluated the complete HMI regarding usefulness, ease of use and perceived visual workload just after experiencing the take-over. They gave comparative ratings on usability and acceptance at the end of the experiment. Results revealed that reaction times, reflecting information processing time (i.e., hands on the steering wheel, termination of NDRT), were shorter for 'Speech+generic' compared to 'Generic' while reaction time, reflecting allocation of attention (i.e., first glance ahead), did not show this difference. Subjective ratings were in favor of the system with additional speech output. Copyright © 2017 Elsevier Ltd. All rights reserved.

Impact of the introduction of generic latanoprost on glaucoma medication adherence.

PubMed

Stein, Joshua D; Shekhawat, Nakul; Talwar, Nidhi; Balkrishnan, Rajesh

2015-04-01

To assess possible changes in medication adherence to prostaglandin analog (PGA) regimens among patients with open-angle glaucoma (OAG) after the initial introduction of generic PGAs. Longitudinal cohort analysis. Patients older than 40 years with OAG continuously enrolled in a nationwide managed-care network during 2009-2012 who used PGAs. Mean adherence rates were calculated for topical PGA use during the 18 months before the introduction of generic latanoprost (September 2009-February 2011) and the 18 months after generic latanoprost became available (July 2011-December 2012). The rates were compared between persons who continued to use brand-name PGAs once generic latanoprost became available and others who switched to generic latanoprost. Multivariable logistic regression identified variables associated with an improvement or worsening of adherence of ≥25%. Mean adherence rates and odds of 25% or more improved or worsened adherence (with 95% confidence intervals [CIs]). A total of 8427 patients met the study eligibility criteria. Compared with persons switching to generic latanoprost, patients who continued taking brand name PGAs were 28% less likely to have improved adherence (odds ratio [OR], 0.72; 95% CI, 0.55-0.94) and 39% more likely to have reduced adherence (OR, 1.39; 1.04-1.86) of ≥25%. Improved adherence after the generic drug's introduction was also associated with higher monthly medication copay in the pregeneric period (P = 0.02), lower copay after introduction of the generic drug (P < 0.0001), and black race (OR, 1.25; 95% CI, 1.04-1.50). Six-hundred twelve patients (7.3%) discontinued all antiglaucoma interventions when generic latanoprost became available. Given that cost can significantly deter adherence, switching patients to generic medications may help improve patients' drug-regimen adherence. A considerable number of patients discontinued glaucoma drug use altogether when generic latanoprost became available. Ophthalmologists should work with insurers and pharmacists to prevent such discontinuation of use as generic forms of other PGA agents become available. Copyright © 2015 American Academy of Ophthalmology. Published by Elsevier Inc. All rights reserved.

Targeting, out-scaling and prioritising climate-smart interventions in agricultural systems: Lessons from applying a generic framework to the livestock sector in sub-Saharan Africa.

PubMed

Notenbaert, An; Pfeifer, Catherine; Silvestri, Silvia; Herrero, Mario

2017-02-01

As a result of population growth, urbanization and climate change, agricultural systems around the world face enormous pressure on the use of resources. There is a pressing need for wide-scale innovation leading to development that improves the livelihoods and food security of the world's population while at the same time addressing climate change adaptation and mitigation. A variety of promising climate-smart interventions have been identified. However, what remains is the prioritization of interventions for investment and broad dissemination. The suitability and adoption of interventions depends on a variety of bio-physical and socio-economic factors. Also their impacts, when adopted and out-scaled, are likely to be highly heterogeneous. This heterogeneity expresses itself not only spatially and temporally but also in terms of the stakeholders affected, some might win and some might lose. A mechanism that can facilitate a systematic, holistic assessment of the likely spread and consequential impact of potential interventions is one way of improving the selection and targeting of such options. In this paper we provide climate smart agriculture (CSA) planners and implementers at all levels with a generic framework for evaluating and prioritising potential interventions. This entails an iterative process of mapping out recommendation domains, assessing adoption potential and estimating impacts. Through examples, related to livestock production in sub-Saharan Africa, we demonstrate each of the steps and how they are interlinked. The framework is applicable in many different forms, scales and settings. It has a wide applicability beyond the examples presented and we hope to stimulate readers to integrate the concepts in the planning process for climate-smart agriculture, which invariably involves multi-stakeholder, multi-scale and multi-objective decision-making.

Pharmaceutical quality of seven generic Levodopa/Benserazide products compared with original Madopar® / Prolopa®.

PubMed

Gasser, Urs E; Fischer, Anton; Timmermans, Jan P; Arnet, Isabelle

2013-04-23

By definition, a generic product is considered interchangeable with the innovator brand product. Controversy exists about interchangeability, and attention is predominantly directed to contaminants. In particular for chronic, degenerative conditions such as in Parkinson's disease (PD) generic substitution remains debated among physicians, patients and pharmacists. The objective of this study was to compare the pharmaceutical quality of seven generic levodopa/benserazide hydrochloride combination products marketed in Germany with the original product (Madopar® / Prolopa® 125, Roche, Switzerland) in order to evaluate the potential impact of Madopar® generics versus branded products for PD patients and clinicians. Madopar® / Prolopa® 125 tablets and capsules were used as reference material. The generic products tested (all 100 mg/25 mg formulations) included four tablet and three capsule formulations. Colour, appearance of powder (capsules), disintegration and dissolution, mass of tablets and fill mass of capsules, content, identity and amounts of impurities were assessed along with standard physical and chemical laboratory tests developed and routinely practiced at Roche facilities. Results were compared to the original "shelf-life" specifications in use by Roche. Each of the seven generic products had one or two parameters outside the specifications. Deviations for the active ingredients ranged from +8.4% (benserazide) to -7.6% (levodopa) in two tablet formulations. Degradation products were measured in marked excess (+26.5%) in one capsule formulation. Disintegration time and dissolution for levodopa and benserazide hydrochloride at 30 min were within specifications for all seven generic samples analysed, however with some outliers. Deviations for the active ingredients may go unnoticed by a new user of the generic product, but may entail clinical consequences when switching from original to generic during a long-term therapy. Degradation products may pose a safety concern. Our results should prompt caution when prescribing a generic of Madopar®/Prolopa®, and also invite to further investigations in view of a more comprehensive approach, both pharmaceutical and clinical.

Attitudes of Slovene general practitioners towards generic drug prescribing and comparison with international studies.

PubMed

Kersnik, J; Peklar, J

2006-12-01

Over the recent years there has been a steady 7% yearly increase in prescribing costs, which accounts for 17% of the Slovene national health care budget. Substitution of branded products by generic equivalents can offer savings. General practitioners (GPs) are often concerned about the quality of generic products and possible legal liabilities associated with their use. We wanted to examine the attitudes of GPs in Slovenia towards generic drug prescribing. We conducted a postal survey of a random sample of 200 out of 800 GPs in Slovenia from the National Health Insurance Institute database. GPs were asked 21 questions regarding their knowledge on generic drugs, awareness of prescribing costs, prices of generic drugs relative to brand name drugs and their attitude towards use of generic drugs. The 117 (58.5%) replies we received represent 15% of the GP population in Slovenia. 66.1% of GPs considered rising costs of medicines to be a serious problem for the health care budget. Each week, over 50% of GPs experienced demands from patients for specific drugs and the majority of GPs usually met their patients' demands or requests from hospital consultants for branded products. 38.3% of GPs did not take price into consideration when prescribing drugs. The majority of GPs (88.9%) perceived generics to have the same effectiveness as branded drugs. One quarter of GPs would prescribe more generics if additional clinical trials were presented. 37.3% would follow advice of academic detailers and 30.3% expected the generics to be even cheaper than they were. Independent detailing was welcomed by 63.8% of GPs because of the big influence of the pharmaceutical industry on the prescribing habits. 15.5% thought that the industry had a tremendous impact on their prescribing patterns. Slovene GPs are aware of the cost of prescribed drugs. They are willing to accept independent academic detailing to improve their prescribing and are willing to increase generic drugs under certain conditions.

Select Generic Dry-Storage Pilot Plant Design for Safeguards and Security by Design (SSBD) per Used Fuel Campaign

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

Demuth, Scott Francis; Sprinkle, James K.

As preparation to the year-end deliverable (Provide SSBD Best Practices for Generic Dry-Storage Pilot Scale Plant) for the Work Package (FT-15LA040501–Safeguards and Security by Design for Extended Dry Storage), the initial step was to select a generic dry-storage pilot plant design for SSBD. To be consistent with other DOE-NE Fuel Cycle Research and Development (FCR&D) activities, the Used Fuel Campaign was engaged for the selection of a design for this deliverable. For the work Package FT-15LA040501–“Safeguards and Security by Design for Extended Dry Storage”, SSBD will be initiated for the Generic Dry-Storage Pilot Scale Plant described by the layout ofmore » Reference 2. SSBD will consider aspects of the design that are impacted by domestic material control and accounting (MC&A), domestic security, and international safeguards.« less

Some drugs more equal than others: pseudo-generics and commercial practice.

PubMed

Probyn, Andrew J

2004-11-08

This article analyses the impact of the Department of Health and Ageing's brand price premium policy for some products listed on the Pharmaceutical Benefits Scheme. The policy, introduced in 1990, allows pharmaceutical companies to charge patients an out-of-pocket expense for post-patent brands of pharmaceuticals. One of the policy's intended goals was to increase consumer awareness of price differentials between competing brands, with a view to encouraging greater use of cheaper generic products. More than fourteen years since its introduction, it is debatable whether the policy has achieved this aim. This article looks at how the brand price premium policy can be exploited by global pharmaceutical giants to entrench big-name brands in the Australian pharmaceutical market and, in some cases, prevent 'true' competition from generic pharmaceuticals. This is being done through the establishment of 'pseudo-generics' that are sourced from the same factory floor as the original product.

How Low-Income Subsidy Recipients Respond to Medicare Part D Cost Sharing.

PubMed

Stuart, Bruce; Hendrick, Franklin B; Xu, Jing; Dougherty, J Samantha

2017-06-01

To determine the magnitude and mechanisms of response to Medicare Part D cost sharing by low-income subsidy (LIS) recipients using oral hypoglycemic agents (OHAs) and statins. Medicare data for a 5 percent random sample of beneficiaries with diabetes enrolled in fee-for-service Part D drug plans in 2008. We evaluated the impact of differences between generic and brand cost sharing rates among cohorts of LIS and non-LIS recipients to determine if wider price spreads increased the generic dispensing rate (GDR) and reduced total drug use and cost. We found little association between cost sharing and aggregate OHA and statin use. In adjusted analyses, non-LIS beneficiaries who paid 46 percent of total OHA costs had 2.5 percent fewer OHA days supply than full benefit dual eligibles who paid just 5 percent of their therapy costs. For statins, the difference in days supply between those facing the lowest and highest cost sharing was 4.6 percent. Higher cost sharing was associated with filling fewer but larger prescriptions for both generics and brands. Higher generic and brand copays had little association with OHA and statin use among LIS recipients. This implies that modest changes in required cost sharing for these medicines would have very little substantive impact on generic dispensing or utilization patterns among LIS recipients and thus would have little effect on total program spending. At the same time, any increases in out-of-pocket costs would be expected to shift costs and place greater financial burden on low-income beneficiaries, particularly those in poor health. © Health Research and Educational Trust.

Architecture design of a generic centralized adjudication module integrated in a web-based clinical trial management system.

PubMed

Zhao, Wenle; Pauls, Keith

2016-04-01

Centralized outcome adjudication has been used widely in multicenter clinical trials in order to prevent potential biases and to reduce variations in important safety and efficacy outcome assessments. Adjudication procedures could vary significantly among different studies. In practice, the coordination of outcome adjudication procedures in many multicenter clinical trials remains as a manual process with low efficiency and high risk of delay. Motivated by the demands from two large clinical trial networks, a generic outcome adjudication module has been developed by the network's data management center within a homegrown clinical trial management system. In this article, the system design strategy and database structure are presented. A generic database model was created to transfer different adjudication procedures into a unified set of sequential adjudication steps. Each adjudication step was defined by one activate condition, one lock condition, one to five categorical data items to capture adjudication results, and one free text field for general comments. Based on this model, a generic outcome adjudication user interface and a generic data processing program were developed within a homegrown clinical trial management system to provide automated coordination of outcome adjudication. By the end of 2014, this generic outcome adjudication module had been implemented in 10 multicenter trials. A total of 29 adjudication procedures were defined with the number of adjudication steps varying from 1 to 7. The implementation of a new adjudication procedure in this generic module took an experienced programmer 1 or 2 days. A total of 7336 outcome events had been adjudicated and 16,235 adjudication step activities had been recorded. In a multicenter trial, 1144 safety outcome event submissions went through a three-step adjudication procedure and reported a median of 3.95 days from safety event case report form submission to adjudication completion. In another trial, 277 clinical outcome events were adjudicated by a six-step procedure and took a median of 23.84 days from outcome event case report form submission to adjudication procedure completion. A generic outcome adjudication module integrated in the clinical trial management system made the automated coordination of efficacy and safety outcome adjudication a reality. © The Author(s) 2015.

Air impacts of increased natural gas acquisition, processing, and use: a critical review.

PubMed

Moore, Christopher W; Zielinska, Barbara; Pétron, Gabrielle; Jackson, Robert B

2014-01-01

During the past decade, technological advancements in the United States and Canada have led to rapid and intensive development of many unconventional natural gas plays (e.g., shale gas, tight sand gas, coal-bed methane), raising concerns about environmental impacts. Here, we summarize the current understanding of local and regional air quality impacts of natural gas extraction, production, and use. Air emissions from the natural gas life cycle include greenhouse gases, ozone precursors (volatile organic compounds and nitrogen oxides), air toxics, and particulates. National and state regulators primarily use generic emission inventories to assess the climate, air quality, and health impacts of natural gas systems. These inventories rely on limited, incomplete, and sometimes outdated emission factors and activity data, based on few measurements. We discuss case studies for specific air impacts grouped by natural gas life cycle segment, summarize the potential benefits of using natural gas over other fossil fuels, and examine national and state emission regulations pertaining to natural gas systems. Finally, we highlight specific gaps in scientific knowledge and suggest that substantial additional measurements of air emissions from the natural gas life cycle are essential to understanding the impacts and benefits of this resource.

Patient safety climate and worker safety behaviours in acute hospitals in Scotland.

PubMed

Agnew, Cakil; Flin, Rhona; Mearns, Kathryn

2013-06-01

To obtain a measure of hospital safety climate from a sample of National Health Service (NHS) acute hospitals in Scotland and to test whether these scores were associated with worker safety behaviors, and patient and worker injuries. Data were from 1,866 NHS clinical staff in six Scottish acute hospitals. A Scottish Hospital Safety Questionnaire measured hospital safety climate (Hospital Survey on Patient Safety Culture), worker safety behaviors, and worker and patient injuries. The associations between the hospital safety climate scores and the outcome measures (safety behaviors, worker and patient injury rates) were examined. Hospital safety climate scores were significantly correlated with clinical workers' safety behavior and patient and worker injury measures, although the effect sizes were smaller for the latter. Regression analyses revealed that perceptions of staffing levels and managerial commitment were significant predictors for all the safety outcome measures. Both patient-specific and more generic safety climate items were found to have significant impacts on safety outcome measures. This study demonstrated the influences of different aspects of hospital safety climate on both patient and worker safety outcomes. Moreover, it has been shown that in a hospital setting, a safety climate supporting safer patient care would also help to ensure worker safety. The Scottish Hospital Safety Questionnaire has proved to be a usable method of measuring both hospital safety climate as well as patient and worker safety outcomes. Copyright © 2013 National Safety Council and Elsevier Ltd. Published by Elsevier Ltd. All rights reserved.

Determining the minimal clinically important difference criteria for the Multidimensional Fatigue Inventory in a radiotherapy population.

PubMed

Purcell, Amanda; Fleming, Jennifer; Bennett, Sally; Burmeister, Bryan; Haines, Terry

2010-03-01

The Multidimensional Fatigue Inventory (MFI) is a commonly used cancer-related fatigue assessment tool. Unlike other fatigue assessments, there are no published minimal clinically important difference (MCID) criteria for the MFI in cancer populations. MCID criteria determine the smallest change in scores that can be regarded as important, allowing clinicians and researchers to interpret the meaning of changes in patient's fatigue scores. This research aims to improve the clinical utility of the MFI by establishing MCID criteria for the MFI sub-scales in a radiotherapy population. Two hundred ten patients undergoing radiotherapy were recruited to a single-centre prospective cohort study. Patients were assessed at three time points, at the start of radiotherapy, the end of radiotherapy and 6 weeks after radiotherapy completion. Assessment consisted of four clinically relevant constructs: (1) treatment impact on fatigue, (2) health-related quality of life, (3) performance status and (4) occupational productivity. These constructs were used as external or anchor-based measures to determine MCIDs for each sub-scale of the MFI. Multiple MCIDs were identified, each from a different perspective based on the constructs cited. Researchers seeking to use a generic MCID may wish to use a two-point reference for each MFI sub-scale as it was consistent across the pre- and post-radiotherapy comparison and occupational productivity anchors. MCIDs validated in this study allow better interpretation of changes in MFI sub-scale scores and allow effect size calculations for determining sample size in future studies.

Prospective evaluation of quality of life in children treated in UKALL 2003 for acute lymphoblastic leukaemia: A cohort study.

PubMed

Eiser, C; Stride, C B; Vora, A; Goulden, N; Mitchell, C; Buck, G; Adams, M; Jenney, M E M

2017-11-01

Health-related quality of life (HRQoL) from diagnosis until end of treatment for children with acute lymphoblastic leukaemia was investigated, examining effects of age, gender, risk-stratified treatment regimen, and therapy intensity (one vs. two 'delayed intensifications' [DIs]). In a multi-centre prospective study, parents reported their child's generic and disease-specific HRQoL and their own care-giving burden at five time points. From 1,428 eligible patients, 874 parents completed questionnaires at least once during treatment. At each time point, generic HRQoL was significantly lower than equivalent norm scores for healthy children. HRQoL decreased significantly at the start of treatment, before recovering gradually (but remained below pre-treatment levels). Parents reported that older children worried more about side effects and their appearance, but showed less procedural anxiety than younger children. Concern for appearance was greater among girls than boys. Compared to Regimen B (i.e. additional doxorubicin during induction and additional cyclophosphamide and cytarabine during consolidation chemotherapy), patients receiving Regimen A had fewer problems with pain and nausea. There were no statistically significant differences in HRQoL by number of DI blocks received. HRQoL is compromised at all stages of treatment, and is partly dependent on age. The findings increase understanding of the impact of therapy on children's HRQoL and parental care-giving burden, and will contribute to the design of future trials. © 2017 The Authors. Pediatric Blood & Cancer Published by Wiley Periodicals, Inc.

Report of chronic myeloid leukemia SMS Medical College Hospital, Jaipur

PubMed Central

Malhotra, Hemant; Sharma, Rajesh; Singh, Yogender; Chaturvedi, Hemant

2013-01-01

This is a retrospective analysis of patients of chronic myeloid leukemia (CML) registered and under treatment at the Leukemia Lymphoma Clinic at the Birla Cancer Center, SMS Medical College Hospital, Jaipur. Approximately, two-thirds of the patients are getting imatinib mesylate (IM) through the Glivec International Patient Assistance Program while the rest are on generic IM. In addition to comparison of hematological and molecular responses in the Glivec versus the genetic group, in this analysis, an attempt is also made to assess the socio-economic (SE) status of the patients and its effect on the response rates. Of the 213 patients studied, most (28.6%) are in the age group between 30 years and 40 years and the mean age of the patients in 39 years, a good decade younger that in the west. There is a suggestion that patients in lower SE class present with higher Sokal scores and with more disease burden. Possibly hematological responses are similar with both Glivec and generic IM. No comment can be made with regards to molecular response between the two groups as a significant number of patients in the Glivec arm (42%) do not have molecular assessment because of economic reasons. CML is a common and challenging disease in the developing world with patients presenting at an earlier age with more advanced disease. SE factors play a significant role in therapy and disease monitoring decision making and may impact on response rates and prognosis. PMID:24516303

Report of chronic myeloid leukemia SMS Medical College Hospital, Jaipur.

PubMed

Malhotra, Hemant; Sharma, Rajesh; Singh, Yogender; Chaturvedi, Hemant

2013-07-01

This is a retrospective analysis of patients of chronic myeloid leukemia (CML) registered and under treatment at the Leukemia Lymphoma Clinic at the Birla Cancer Center, SMS Medical College Hospital, Jaipur. Approximately, two-thirds of the patients are getting imatinib mesylate (IM) through the Glivec International Patient Assistance Program while the rest are on generic IM. In addition to comparison of hematological and molecular responses in the Glivec versus the genetic group, in this analysis, an attempt is also made to assess the socio-economic (SE) status of the patients and its effect on the response rates. Of the 213 patients studied, most (28.6%) are in the age group between 30 years and 40 years and the mean age of the patients in 39 years, a good decade younger that in the west. There is a suggestion that patients in lower SE class present with higher Sokal scores and with more disease burden. Possibly hematological responses are similar with both Glivec and generic IM. No comment can be made with regards to molecular response between the two groups as a significant number of patients in the Glivec arm (42%) do not have molecular assessment because of economic reasons. CML is a common and challenging disease in the developing world with patients presenting at an earlier age with more advanced disease. SE factors play a significant role in therapy and disease monitoring decision making and may impact on response rates and prognosis.

Impact of Laparoscopic Repair of Large Hiatus Hernia on Quality of Life: Observational Cohort Study.

PubMed

Siboni, Stefano; Asti, Emanuele; Milito, Pamela; Bonitta, Gianluca; Sironi, Andrea; Aiolfi, Alberto; Bonavina, Luigi

2018-06-20

Laparoscopic surgery has proven safe and effective in the treatment of large hiatus hernia. Differences may exist between objectively assessed surgical outcomes, symptomatic scores, and patient-reported outcomes. An observational, single-arm cohort study was conducted in patients undergoing primary laparoscopic repair with crura mesh augmentation and Toupet fundoplication for large (> 50% of intrathoracic stomach) type III-IV hiatus hernia. Data were extracted from hospital charts and a prospectively updated research database. The main study outcome was quality of life assessed by the Gastroesophageal reflux disease Health-Related Quality of Life (GERD-HRQL) score and the Short-form 36 (SF-36). Between 2013 and 2016, 37 out of 49 operated patients completed the comprehensive quality-of-life evaluation at the 2-year follow-up. The GERD-HRQL score significantly decreased compared to baseline (p < 0.001). All items of the SF-36 significantly improved compared to baseline (p < 0.05). Both Physical and Mental Component Summary scores were significantly higher than preoperative scores, with a medium Cohen's effect size (-0.77 and 0.56, respectively). At the 2-year follow-up, symptoms had disappeared in the majority of patients. The use of proton-pump inhibitors significantly decreased compared to baseline (13.5 vs. 86.4%, p < 0.001). Also, the use of antidepressants and benzodiazepines significantly decreased after surgery (8.1 vs. 32.4%, p < 0.001). The overall alimentary satisfaction score was > 8 in 92% of patients. There were no safety issues related to the use of the absorbable synthetic mesh. The incidence of anatomical hernia recurrence was 5.4%, but no patient with recurrent hernia required surgical revision. Laparoscopic repair of large hiatus hernia with mesh and partial fundoplication is associated with symptomatic relief, no side-effects, and a significant improvement in disease-specific and generic quality of life at 2-year follow-up. © 2018 S. Karger AG, Basel.

Accuracy and completeness of drug information in Wikipedia medication monographs.

PubMed

Reilly, Timothy; Jackson, William; Berger, Victoria; Candelario, Danielle

The primary objective of this study was to determine the accuracy and completeness of drug information on Wikipedia and Micromedex compared with U.S. Food and Drug Administration-approved U.S. product inserts. The top 10 brand and top 10 generic medications from the 2012 Institute for Health Informatics' list of top 200 drugs were selected for evaluation. Wikipedia medication information was evaluated and compared with Micromedex in 7 sections of drug information; the U.S. product inserts were used as the standard comparator. Wikipedia demonstrated significantly lower completeness and accuracy scores compared with Micromedex (mean composite scores 18.55 vs. 38.4, respectively; P <0.01). No difference was found between the mean composite scores for brand versus generic drugs in either reference (17.8 vs. 19.3, respectively [P = 0.62], for Wikipedia; 39.2 vs. 37.6, [P = 0.06] for Micromedex). Limitations to these results include the speed with which information is edited on Wikipedia, that there was no evaluation of off-label information, and the limited number of drugs that were evaluated. Wikipedia lacks the accuracy and completeness of standard clinical references and should not be a routine part of clinical decision making. More research should be conducted to evaluate the rationale for health care providers' use of Wikipedia. Copyright © 2016 American Pharmacists Association®. Published by Elsevier Inc. All rights reserved.

Developing multiple-choices test items as tools for measuring the scientific-generic skills on solar system

NASA Astrophysics Data System (ADS)

Bhakti, Satria Seto; Samsudin, Achmad; Chandra, Didi Teguh; Siahaan, Parsaoran

2017-05-01

The aim of research is developing multiple-choices test items as tools for measuring the scientific of generic skills on solar system. To achieve the aim that the researchers used the ADDIE model consisting Of: Analyzing, Design, Development, Implementation, dan Evaluation, all of this as a method research. While The scientific of generic skills limited research to five indicator including: (1) indirect observation, (2) awareness of the scale, (3) inference logic, (4) a causal relation, and (5) mathematical modeling. The participants are 32 students at one of junior high schools in Bandung. The result shown that multiple-choices that are constructed test items have been declared valid by the expert validator, and after the tests show that the matter of developing multiple-choices test items be able to measuring the scientific of generic skills on solar system.

Healthcare Costs Associated with Switching from Brand to Generic Levothyroxine

PubMed Central

Katz, Michael; Scherger, Joseph; Conard, Scott; Montejano, Leslie; Chang, Stella

2010-01-01

Background Controversy exists over the true therapeutic equivalence of branded and generic levothyroxine—the drug of choice for treating hypothyroidism—so professional societies recommend against switching between different formulations of the drug and suggest that patients who do switch be monitored. Payers typically encourage switching to generic drugs because of lower drug acquisition costs. Objective To evaluate the impact of switching levothyroxine formulations on actual healthcare costs. Methods Patients with hypothyroidism and at least 6 months of branded levothyroxine therapy were identified from a large healthcare claims database. Patients who subsequently switched to another levothyroxine formulation and could be followed for 6 months postswitch were matched to demographically similar patients who were continuous users of branded levothyroxine. Pre- and postswitch healthcare costs for each group were compared. Results The savings in prescription drug costs after switching from branded to generic levothyroxine are offset by increases in costs for other healthcare services, such that switching is actually associated with an increase, not a decrease, in total healthcare costs. Conclusion In the absence of cost-savings, there is no clear rationale for switching patients from brand to generic levothyroxine. PMID:25126314

Measurement of COPD Severity Using a Survey-Based Score

PubMed Central

Omachi, Theodore A.; Katz, Patricia P.; Yelin, Edward H.; Iribarren, Carlos; Blanc, Paul D.

2010-01-01

Background: A comprehensive survey-based COPD severity score has usefulness for epidemiologic and health outcomes research. We previously developed and validated the survey-based COPD Severity Score without using lung function or other physiologic measurements. In this study, we aimed to further validate the severity score in a different COPD cohort and using a combination of patient-reported and objective physiologic measurements. Methods: Using data from the Function, Living, Outcomes, and Work cohort study of COPD, we evaluated the concurrent and predictive validity of the COPD Severity Score among 1,202 subjects. The survey instrument is a 35-point score based on symptoms, medication and oxygen use, and prior hospitalization or intubation for COPD. Subjects were systemically assessed using structured telephone survey, spirometry, and 6-min walk testing. Results: We found evidence to support concurrent validity of the score. Higher COPD Severity Score values were associated with poorer FEV1 (r = −0.38), FEV1% predicted (r = −0.40), Body mass, Obstruction, Dyspnea, Exercise Index (r = 0.57), and distance walked in 6 min (r = −0.43) (P < .0001 in all cases). Greater COPD severity was also related to poorer generic physical health status (r = −0.49) and disease-specific health-related quality of life (r = 0.57) (P < .0001). The score also demonstrated predictive validity. It was also associated with a greater prospective risk of acute exacerbation of COPD defined as ED visits (hazard ratio [HR], 1.31; 95% CI, 1.24-1.39), hospitalizations (HR, 1.59; 95% CI, 1.44-1.75), and either measure of hospital-based care for COPD (HR, 1.34; 95% CI, 1.26-1.41) (P < .0001 in all cases). Conclusion: The COPD Severity Score is a valid survey-based measure of disease-specific severity, both in terms of concurrent and predictive validity. The score is a psychometrically sound instrument for use in epidemiologic and outcomes research in COPD. PMID:20040611

Mapping the Paediatric Quality of Life Inventory (PedsQL™) Generic Core Scales onto the Child Health Utility Index-9 Dimension (CHU-9D) Score for Economic Evaluation in Children.

PubMed

Lambe, Tosin; Frew, Emma; Ives, Natalie J; Woolley, Rebecca L; Cummins, Carole; Brettell, Elizabeth A; Barsoum, Emma N; Webb, Nicholas J A

2018-04-01

The Paediatric Quality of Life Inventory (PedsQL™) questionnaire is a widely used, generic instrument designed for measuring health-related quality of life (HRQoL); however, it is not preference-based and therefore not suitable for cost-utility analysis. The Child Health Utility Index-9 Dimension (CHU-9D), however, is a preference-based instrument that has been primarily developed to support cost-utility analysis. This paper presents a method for estimating CHU-9D index scores from responses to the PedsQL™ using data from a randomised controlled trial of prednisolone therapy for treatment of childhood corticosteroid-sensitive nephrotic syndrome. HRQoL data were collected from children at randomisation, week 16, and months 12, 18, 24, 36 and 48. Observations on children aged 5 years and older were pooled across all data collection timepoints and were then randomised into an estimation (n = 279) and validation (n = 284) sample. A number of models were developed using the estimation data before internal validation. The best model was chosen using multi-stage selection criteria. Most of the models developed accurately predicted the CHU-9D mean index score. The best performing model was a generalised linear model (mean absolute error = 0.0408; mean square error = 0.0035). The proportion of index scores deviating from the observed scores by <  0.03 was 53%. The mapping algorithm provides an empirical tool for estimating CHU-9D index scores and for conducting cost-utility analyses within clinical studies that have only collected PedsQL™ data. It is valid for children aged 5 years or older. Caution should be exercised when using this with children younger than 5 years, older adolescents (>  13 years) or patient groups with particularly poor quality of life. 16645249.

Sex is associated with differences in individual trajectories of change in social health after implantable cardioverter-defibrillator.

PubMed

Lauck, Sandra B; Sawatzky, Richard; Johnson, Joy L; Humphries, Karin; Bennett, Matthew T; Chakrabarti, Santabhanu; Kerr, Charles R; Tung, Stanley; Yeung-Lai-Wah, John A; Ratner, Pamela A

2015-03-01

Social health is a dimension of quality of life, and refers to people's involvement in, and satisfaction with social roles, responsibilities, and activities. The implantable cardioverter-defibrillator is associated with changes in overall quality of life, but little is known about sex differences in individual trajectories of change in social health. We prospectively measured changes in 3 subscales of the SF-36v2 generic health questionnaire (role physical, role emotional, and social functioning), 2 Patient-Reported Outcomes Measurement Information System short forms (satisfaction with participation in social roles and satisfaction with participation in discretionary social activities), and the Florida Patient Acceptance Survey before and at 1, 2, and 6 months after implantation. Individual growth models of temporal change were estimated. The scores of the 6 indicators improved with time. The unconditional model demonstrated significant (fixed effects: P<0.05; covariance parameters: P<0.10) residual variability in the individual trajectories. In the conditional model, men and women differed significantly in their rates of change in the scores of 3 of the 6 measures. Although men's mean scores exceeded women's mean scores on all indicators at baseline (range of relative mean difference: 11.0% to 17.8%), the rate of women's change resulted in a reversal in relative standing at 6 months after implantation, with the mean scores of women exceeding the men's by 4.5% to 5.6%. Men and women differed in their trajectories of change in social health, both in terms of their starting points (ie, baseline scores) and their rates of change. © 2015 American Heart Association, Inc.

Brand and generic use of inhalation medication and frequency of switching in children and adults: A population-based cohort study.

PubMed

Engelkes, Marjolein; van Blijderveen, Jan C; Overbeek, Jetty A; Kuiper, Josephine; Herings, Ron C M; Sturkenboom, Miriam C J M; de Jongste, Johan C; Verhamme, Katia M C; Janssens, Hettie M

2017-11-29

The expiration of patents of brand inhalation medications and the ongoing pressure on healthcare budgets resulted in a growing market for generics. To study the use of brand and generic inhalation medication and the frequency of switching between brand and generic and between devices. In addition, we investigated whether switching affected adherence. From dispensing data from the Dutch PHARMO Database Network a cohort aged ≥ 5 years, using ≥ 1 year of inhalation medication between 2003 and 2012 was selected. Switching was defined as changing from brand to generic or vice versa. In addition, we studied change in aerosol delivery device type (e.g., DPI, pMDI, and nebulizers). Adherence was calculated using the medication possession ratio (MPR). The total cohort comprised 70,053 patients with 1,604,488 dispensations. Per calendar year, 5% switched between brand and generic inhalation medication and 5% switched between devices. Median MPRs over the first 12 months ranged between 33 and 55%. Median MPR over the total period was lower after switch from brand to generic and vice versa for formoterol (44.5 vs. 42.1 and 63.5 vs. 53.8) and beclomethasone (93.8 vs. 59.8 and 81.3 vs. 55.9). Per year, switching between brand and generic inhalation medication was limited to 5% of the patients, switching between device types was observed in 5% as well. Adherence to both generic and brand inhalation medication was low. Effect of switching on adherence was contradictory; depending on time period, medication and type, and direction of switching. Further research on reasons for switching and potential impact on clinical outcomes is warranted.

Effects of an e-Prescribing interface redesign on rates of generic drug prescribing: exploiting default options.

PubMed

Malhotra, Sameer; Cheriff, Adam D; Gossey, J Travis; Cole, Curtis L; Kaushal, Rainu; Ancker, Jessica S

2016-09-01

Increasing the use of generic medications could help control medical costs. However, educational interventions have limited impact on prescriber behavior, and e-prescribing alerts are associated with high override rates and alert fatigue. Our objective was to evaluate the effect of a less intrusive intervention, a redesign of an e-prescribing interface that provides default options intended to "nudge" prescribers towards prescribing generic drugs. This retrospective cohort study in an academic ambulatory multispecialty practice assessed the effects of customizing an e-prescribing interface to substitute generic equivalents for brand-name medications during order entry and allow a one-click override to order the brand-name medication. Among drugs with generic equivalents, the proportion of generic drugs prescribed more than doubled after the interface redesign, rising abruptly from 39.7% to 95.9% (a 56.2% increase; 95% confidence interval, 56.0-56.4%; P < .001). Before the redesign, generic drug prescribing rates varied by therapeutic class, with rates as low as 8.6% for genitourinary products and 15.7% for neuromuscular drugs. After the redesign, generic drug prescribing rates for all but four therapeutic classes were above 90%: endocrine drugs, neuromuscular drugs, nutritional products, and miscellaneous products. Changing the default option in an e-prescribing interface in an ambulatory care setting was followed by large and sustained increases in the proportion of generic drugs prescribed at the practice. Default options in health information technology exert a powerful effect on user behavior, an effect that can be leveraged to optimize decision making. © The Author 2016. Published by Oxford University Press on behalf of the American Medical Informatics Association. All rights reserved. For Permissions, please email: journals.permissions@oup.com.

A review of the differences and similarities between generic drugs and their originator counterparts, including economic benefits associated with usage of generic medicines, using Ireland as a case study.

PubMed

Dunne, Suzanne; Shannon, Bill; Dunne, Colum; Cullen, Walter

2013-01-05

Generic medicines are those where patent protection has expired, and which may be produced by manufacturers other than the innovator company. Use of generic medicines has been increasing in recent years, primarily as a cost saving measure in healthcare provision. Generic medicines are typically 20 to 90% cheaper than originator equivalents. Our objective is to provide a high-level description of what generic medicines are and how they differ, at a regulatory and legislative level, from originator medicines. We describe the current and historical regulation of medicines in the world's two main pharmaceutical markets, in addition to the similarities, as well as the differences, between generics and their originator equivalents including the reasons for the cost differences seen between originator and generic medicines. Ireland is currently poised to introduce generic substitution and reference pricing. This article refers to this situation as an exemplar of a national system on the cusp of significant health policy change, and specifically details Ireland's history with usage of generic medicines and how the proposed changes could affect healthcare provision.

A review of the differences and similarities between generic drugs and their originator counterparts, including economic benefits associated with usage of generic medicines, using Ireland as a case study

PubMed Central

2013-01-01

Generic medicines are those where patent protection has expired, and which may be produced by manufacturers other than the innovator company. Use of generic medicines has been increasing in recent years, primarily as a cost saving measure in healthcare provision. Generic medicines are typically 20 to 90% cheaper than originator equivalents. Our objective is to provide a high-level description of what generic medicines are and how they differ, at a regulatory and legislative level, from originator medicines. We describe the current and historical regulation of medicines in the world’s two main pharmaceutical markets, in addition to the similarities, as well as the differences, between generics and their originator equivalents including the reasons for the cost differences seen between originator and generic medicines. Ireland is currently poised to introduce generic substitution and reference pricing. This article refers to this situation as an exemplar of a national system on the cusp of significant health policy change, and specifically details Ireland’s history with usage of generic medicines and how the proposed changes could affect healthcare provision. PMID:23289757

Impact of a new simplified disability scoring system for adult patients with localized scleroderma.

PubMed

Okiyama, Naoko; Asano, Yoshihide; Hamaguchi, Yasuhito; Jinnin, Masatoshi; Motegi, Sei-Ichiro; Koizumi, Haruka; Hasegawa, Minoru; Ishikawa, Osamu; Sato, Shinichi; Takehara, Kazuhiko; Yamamoto, Toshiyuki; Fujimoto, Manabu; Ihn, Hironobu

2018-04-01

Localized scleroderma (LoS) involves dermal but not internal inflammation and fibrosis. Cosmetic changes often impact quality of life (QOL), however, impairment of activities of daily living (ADL) in LoS patients has not been investigated. To determine what factor(s) are associated with ADL in adult patients with LoS, we performed a retrospective observational study in 177 Japanese adult LoS patients using a novel LoS disability score based on Barthel's indices of ADL: feeding, bathing, grooming, dressing, bowels, bladder, toilet use, transfers, mobility and stairs. LoS disability scores increased in proportion to the number of affected body parts but were not correlated to age and duration of illness. The presence of leg lesions significantly impaired ADL of LoS patients compared with lesions on other body parts. Patients treated with systemic medications, who tended to have multiple lesions, presented higher LoS disability scores than those without systemic treatments. Our study proposes that physicians evaluate ADL, not only QOL, in LoS patients. Our findings using LoS disability scoring indicate that multiple affected body parts and leg lesions are risk factors for ADL impairment. © 2018 Japanese Dermatological Association.

78 FR 37324 - Preparation of Environmental Reports for Nuclear Power Plant License Renewal Applications

Federal Register 2010, 2011, 2012, 2013, 2014

2013-06-20

... Commission's 1996 findings on the environmental impacts of renewing the operating license of a nuclear power.... Specifically, the final rule amends Table B-1 by redefining the number and scope of the environmental impact... is publishing Revision 1 to NUREG-1437, ``Generic Environmental Impact Statement for License Renewal...

Image processing in biodosimetry: A proposal of a generic free software platform.

PubMed

Dumpelmann, Matthias; Cadena da Matta, Mariel; Pereira de Lemos Pinto, Marcela Maria; de Salazar E Fernandes, Thiago; Borges da Silva, Edvane; Amaral, Ademir

2015-08-01

The scoring of chromosome aberrations is the most reliable biological method for evaluating individual exposure to ionizing radiation. However, microscopic analyses of chromosome human metaphases, generally employed to identify aberrations mainly dicentrics (chromosome with two centromeres), is a laborious task. This method is time consuming and its application in biological dosimetry would be almost impossible in case of a large scale radiation incidents. In this project, a generic software was enhanced for automatic chromosome image processing from a framework originally developed for the Framework V project Simbio, of the European Union for applications in the area of source localization from electroencephalographic signals. The platforms capability is demonstrated by a study comparing automatic segmentation strategies of chromosomes from microscopic images.

Dream content: Individual and generic aspects.

PubMed

Hobson, Allan; Kahn, David

2007-12-01

Dream reports were collected from normal subjects in an effort to determine the degree to which dream reports can be used to identify individual dreamers. Judges were asked to group the reports by their authors. The judges scored the reports correctly at chance levels. This finding indicated that dreams may be at least as much like each other as they are the signature of individual dreamers. Our results suggest that dream reports cannot be used to identify the individuals who produced them when identifiers like names and gender of friends and family members are removed from the dream report. In addition to using dreams to learn about an individual, we must look at dreams as telling us about important common or generic aspects of human consciousness.

Baldrige Theory into Practice: A Generic Model

ERIC Educational Resources Information Center

Arif, Mohammed

2007-01-01

Purpose: The education system globally has moved from a push-based or producer-centric system to a pull-based or customer centric system. Malcolm Baldrige Quality Award (MBQA) model happens to be one of the latest additions to the pull based models. The purpose of this paper is to develop a generic framework for MBQA that can be used by…

Common Cause Failure Modeling: Aerospace Versus Nuclear

NASA Technical Reports Server (NTRS)

Stott, James E.; Britton, Paul; Ring, Robert W.; Hark, Frank; Hatfield, G. Spencer

2010-01-01

Aggregate nuclear plant failure data is used to produce generic common-cause factors that are specifically for use in the common-cause failure models of NUREG/CR-5485. Furthermore, the models presented in NUREG/CR-5485 are specifically designed to incorporate two significantly distinct assumptions about the methods of surveillance testing from whence this aggregate failure data came. What are the implications of using these NUREG generic factors to model the common-cause failures of aerospace systems? Herein, the implications of using the NUREG generic factors in the modeling of aerospace systems are investigated in detail and strong recommendations for modeling the common-cause failures of aerospace systems are given.

Biomechanical assessment of a rear-seat inflatable seatbelt in frontal impacts.

PubMed

Sundararajan, Srinivasan; Rouhana, Stephen W; Board, Derek; DeSmet, Ed; Prasad, Priya; Rupp, Jonathan D; Miller, Carl S; Schneider, Lawrence W

2011-11-01

This study evaluated the biomechanical performance of a rear-seat inflatable seatbelt system and compared it to that of a 3-point seatbelt system, which has a long history of good real-world performance. Frontal-impact sled tests were conducted with Hybrid III anthropomorphic test devices (ATDs) and with post mortem human subjects (PMHS) using both restraint systems and a generic rear-seat configuration. Results from these tests demonstrated: a) reduction in forward head excursion with the inflatable seatbelt system when compared to that of a 3-point seatbelt and; b) a reduction in ATD and PMHS peak chest deflections and the number of PMHS rib fractures with the inflatable seatbelt system and c) a reduction in PMHS cervical-spine injuries, due to the interaction of the chin with the inflated shoulder belt. These results suggest that an inflatable seatbelt system will offer additional benefits to some occupants in the rear seats. Further research is needed to assess the field effectiveness, customer comfort and acceptance and change in the belt usage rate with the inflatable seatbelt system.

Measuring School and Teacher Value Added for IMPACT and TEAM in DC Public Schools. Final Report

ERIC Educational Resources Information Center

Isenberg, Eric; Hock, Heinrich

2010-01-01

The District of Columbia Public Schools (DCPS) has incorporated measures of school and teacher effectiveness, based on student test score growth, into a new teacher assessment system known as IMPACT. Implemented for the first time during the 2009-2010 school year, IMPACT is an assessment system with significant consequences. Prior to the start of…

Developing Generic Competences in Online Virtual Education Programmes at the University of Deusto

ERIC Educational Resources Information Center

Gvaramadze, Irakli

2012-01-01

Purpose: The current paper focuses on the increasing demand for generic competences both from governments and industries. Despite this fact, there is insufficient awareness and information in education systems on how to equip graduates with appropriate generic competences for the world of work and citizenship. This is even more complicated in…

Do higher-priced generic medicines enjoy a competitive advantage under reference pricing?

PubMed

Puig-Junoy, Jaume

2012-11-01

In many countries with generic reference pricing, generic producers and distributors compete by means of undisclosed discounts offered to pharmacies in order to reduce acquisition costs and to induce them to dispense their generic to patients in preference over others. The objective of this article is to test the hypothesis that under prevailing reference pricing systems for generic medicines, those medicines sold at a higher consumer price may enjoy a competitive advantage. Real transaction prices for 179 generic medicines acquired by pharmacies in Spain have been used to calculate the discount rate on acquisition versus reimbursed costs to pharmacies. Two empirical hypotheses are tested: the discount rate at which pharmacies acquire generic medicines is higher for those pharmaceutical presentations for which there are more generic competitors; and, the discount rate at which pharmacies acquire generic medicines is higher for those pharmaceutical forms for which the consumer price has declined less in relation to the consumer price of the brand drug before generic entry (higher-priced generic medicines). An average discount rate of 39.3% on acquisition versus reimbursed costs to pharmacies has been observed. The magnitude of the discount positively depends on the number of competitors in the market. The higher the ratio of the consumer price of the generic to that of the brand drug prior to generic entry (i.e. the smaller the price reduction of the generic in relation to the brand drug), the larger the discount rate. Under reference pricing there is intense price competition among generic firms in the form of unusually high discounts to pharmacies on official ex-factory prices reimbursed to pharmacies. However, this effect is highly distorting because it favours those medicines with a higher relative price in relation to the brand price before generic entry.

Patterns of injury to restrained children in side impact motor vehicle crashes: the side impact syndrome.

PubMed

Orzechowski, Kelly M; Edgerton, Elizabeth A; Bulas, Dorothy I; McLaughlin, Patrick M; Eichelberger, Martin R

2003-06-01

Injury patterns among children in frontal collisions have been well documented, but little information exists regarding injuries to children in side impact collisions. Restrained children 14-years-old or younger admitted to the hospital for crash injuries were analyzed. Data concerning injuries, medical treatment, and outcome were correlated with crash data. Case reviews achieved consensus regarding injury contact points. Side impacts were compared with frontal impacts. These results were then compared with data from the National Automotive Sampling System. There were no differences between the groups with respect to age, sex, restraint type, or seat position. Compared with frontal crashes, children in side impacts were more likely to have an Injury Severity Score > 15 (odds ratio [OR], 3.1; 95% confidence interval [CI], 1.7-5.8) and were more likely to have Abbreviated Injury Scale score 2+ injuries to the head (OR, 2.5; 95% CI, 1.4-4.4), chest (OR, 4.0; 95% CI, 2.0-8.0), and cervical spine (OR, 3.7; 95% CI, 1.2-11.3). When compared with National Automotive Sampling System data, similar trends were seen regarding Abbreviated Injury Scale score 2+ injuries to the head, chest, and extremities. In this study population, side impacts resulted in more injuries to the head, cervical spine, and chest. Knowledge of this pattern-the side impact syndrome-can help guide diagnosis, treatment, and prevention strategy.

An intelligent position-specific training system for mission operations

NASA Technical Reports Server (NTRS)

Schneider, M. P.

1992-01-01

Marshall Space Flight Center's (MSFC's) payload ground controller training program provides very good generic training; however, ground controller position-specific training can be improved by including position-specific training systems in the training program. This report explains why MSFC needs to improve payload ground controller position-specific training. The report describes a generic syllabus for position-specific training systems, a range of system designs for position-specific training systems, and a generic development process for developing position-specific training systems. The report also describes a position-specific training system prototype that was developed for the crew interface coordinator payload operations control center ground controller position. The report concludes that MSFC can improve the payload ground controller training program by incorporating position-specific training systems for each ground controller position; however, MSFC should not develop position-specific training systems unless payload ground controller position experts will be available to participate in the development process.

Economic impact of therapeutic substitution of a brand selective serotonin reuptake inhibitor with an alternative generic selective serotonin reuptake inhibitor in patients with major depressive disorder.

PubMed

Wu, Eric Q; Yu, Andrew P; Lauzon, Veronique; Ramakrishnan, Karthik; Marynchenko, Maryna; Ben-Hamadi, Rym; Blum, Steven; Erder, M Haim

2011-04-01

To reduce pharmacy costs, managed care organizations encourage therapeutic substitution from brand to a generic product. However, little is known about whether these cost-containment strategies can also potentially lower total expenditures for payers in treatment of major depressive disorder (MDD). To compare economic outcomes of patients with MDD who were switched from a brand selective serotonin reuptake inhibitor (SSRI) to an alternative generic SSRI for nonmedical reasons versus patients who continued on the brand SSRI. Adult MDD patients in the Ingenix Impact Database (2003-2007) were considered "switchers" if they received treatment with a brand SSRI and were later switched to an alternative generic SSRI for nonmedical reasons. Patients who remained on the brand SSRI (nonswitchers) were matched 1:1 with switchers. All-cause, mental health-related, and MDD-related rates of hospitalizations/emergency department (ED) visits and costs over 6 months were compared both descriptively and by using adjusted regression models. A subgroup analysis on patients who were switched from escitalopram (Lexapro) to an alternative generic SSRI was also performed. The study included 4449 matched pairs. Compared with nonswitchers, switchers had higher risk of all-cause, mental health-related, and MDD-related use of hospitalizations/ED visits (OR 1.15, 1.34, and 1.54, respectively; all p < 0.01) and higher risk-adjusted mental health-related and MDD-related medical costs ($219 and $222, respectively; both p < 0.05). Subgroup analysis on escitalopram showed similar results; switchers experienced higher risk of any-cause, mental health-related, and MDD-related use of hospitalizations/ED visits (OR 1.21, 1.41, and 1.53, respectively; all p < 0.01) and higher risk-adjusted MDD-related medical costs ($151; p < 0.05). Compared with patients who continued on their patented SSRIs, patients who switched to a generic SSRI incurred more resource use of hospitalizations/ED visits and higher MDD-related health-care costs. The effects of therapeutic substitution should be carefully examined, because use of generic alternatives may not be a cost-saving strategy when total health-care costs are considered.

A Generic System-Level Framework for Self-Serve Health Monitoring System through Internet of Things (IoT).

PubMed

Ahmed, Mobyen Uddin; Björkman, Mats; Lindén, Maria

2015-01-01

Sensor data are traveling from sensors to a remote server, data is analyzed remotely in a distributed manner, and health status of a user is presented in real-time. This paper presents a generic system-level framework for a self-served health monitoring system through the Internet of Things (IoT) to facilities an efficient sensor data management.

The formal verification of generic interpreters

NASA Technical Reports Server (NTRS)

Windley, P.; Levitt, K.; Cohen, G. C.

1991-01-01

The task assignment 3 of the design and validation of digital flight control systems suitable for fly-by-wire applications is studied. Task 3 is associated with formal verification of embedded systems. In particular, results are presented that provide a methodological approach to microprocessor verification. A hierarchical decomposition strategy for specifying microprocessors is also presented. A theory of generic interpreters is presented that can be used to model microprocessor behavior. The generic interpreter theory abstracts away the details of instruction functionality, leaving a general model of what an interpreter does.

Space Generic Open Avionics Architecture (SGOAA): Overview

NASA Technical Reports Server (NTRS)

Wray, Richard B.; Stovall, John R.

1992-01-01

A space generic open avionics architecture created for NASA is described. It will serve as the basis for entities in spacecraft core avionics, capable of being tailored by NASA for future space program avionics ranging from small vehicles such as Moon ascent/descent vehicles to large ones such as Mars transfer vehicles or orbiting stations. The standard consists of: (1) a system architecture; (2) a generic processing hardware architecture; (3) a six class architecture interface model; (4) a system services functional subsystem architectural model; and (5) an operations control functional subsystem architectural model.

Generically Used Expert Scheduling System (GUESS): User's Guide Version 1.0

NASA Technical Reports Server (NTRS)

Liebowitz, Jay; Krishnamurthy, Vijaya; Rodens, Ira

1996-01-01

This user's guide contains instructions explaining how to best operate the program GUESS, a generic expert scheduling system. GUESS incorporates several important features for a generic scheduler, including automatic scheduling routines to generate a 'first' schedule for the user, a user interface that includes Gantt charts and enables the human scheduler to manipulate schedules manually, diagnostic report generators, and a variety of scheduling techniques. The current version of GUESS runs on an IBM PC or compatible in the Windows 3.1 or Windows '95 environment.

Long-Term Modeling of Coupled Processes in a Generic Salt Repository for Heat-Generating Nuclear Waste: Analysis of the Impacts of Halite Solubility Constraints

NASA Astrophysics Data System (ADS)

Blanco Martin, L.; Rutqvist, J.; Battistelli, A.; Birkholzer, J. T.

2015-12-01

Rock salt is a potential medium for the underground disposal of nuclear waste because it has several assets, such as its ability to creep and heal fractures and its water and gas tightness in the undisturbed state. In this research, we focus on disposal of heat-generating nuclear waste and we consider a generic salt repository with in-drift emplacement of waste packages and crushed salt backfill. As the natural salt creeps, the crushed salt backfill gets progressively compacted and an engineered barrier system is subsequently created [1]. The safety requirements for such a repository impose that long time scales be considered, during which the integrity of the natural and engineered barriers have to be demonstrated. In order to evaluate this long-term integrity, we perform numerical modeling based on state-of-the-art knowledge. Here, we analyze the impacts of halite dissolution and precipitation within the backfill and the host rock. For this purpose, we use an enhanced equation-of-state module of TOUGH2 that properly includes temperature-dependent solubility constraints [2]. We perform coupled thermal-hydraulic-mechanical modeling and we investigate the influence of the mentioned impacts. The TOUGH-FLAC simulator, adapted for large strains and creep, is used [3]. In order to quantify the importance of salt dissolution and precipitation on the effective porosity, permeability, pore pressure, temperature and stress field, we compare numerical results that include or disregard fluids of variable salinity. The sensitivity of the results to some parameters, such as the initial saturation within the backfill, is also addressed. References: [1] Bechthold, W. et al. Backfilling and Sealing of Underground Repositories for Radioactive Waste in Salt (BAMBUS II Project). Report EUR20621 EN: European Atomic Energy Community, 2004. [2] Battistelli A. Improving the treatment of saline brines in EWASG for the simulation of hydrothermal systems. Proceedings, TOUGH Symposium 2012, Lawrence Berkeley National Laboratory, Berkeley, California, Sept. 17-19, 2012. [3] Blanco-Martín L, Rutqvist J, Birkholzer JT. Long-term modelling of the thermal-hydraulic-mechanical response of a generic salt repository for heat generating nuclear waste. Eng Geol 2015;193:198-211. doi:10.1016/j.enggeo.2015.04.014.

The impact of disease-related impairments on disability and health-related quality of life: a systematic review

PubMed Central

Weisscher, Nadine; de Haan, Rob J; Vermeulen, Marinus

2007-01-01

Background To investigate the interchangeability of measures of disability and health-related quality of life (HRQL) by comparing their associations patterns with disease-related impairment measures in patients with a variety of conditions. Methods A systematic literature search of MEDLINE, EMBASE, Web of Science and a hand search of reference lists through January 2006. Studies were included if they reported associations patterns between impairment and disability and between impairment and HRQL. Correlation coefficients were transformed to Fisher's z effect size (ES(z)). Weighted averages were reported as pooled ES(z) with 95% confidence intervals (CI). Results The relationship between impairment and disability was stronger (pooled ES(z) = 0.69; 95% CI, 0.66 – 0.72) than between impairment and HRQL (pooled ES(z) = 0.38; 95% CI, 0.36 – 0.41). The physical component score (pooled ES(z) = 0.43; 95% CI, 0.39 – 0.47) and disease-specific HRQL (pooled ES(z) = 0.46; 95% CI, 0.40 – 0.51) were stronger associated with impairments than the mental component score (pooled ES(z) = 0.28; 95% CI, 0.20 – 0.36) and generic HRQL (pooled ES(z) = 0.36; 95% CI, 0.33 – 0.39). Conclusion This study shows measures of disability and different HRQL domains were not equally related to impairment. Patient's impairments are better reflected in disability measures, than in HRQL instruments. There are many outcomes of interest and precisely defining them and measuring them will improve assessing the impact of new interventions. PMID:17578571

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.

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.

The PedsQL 4.0 as a school population health measure: feasibility, reliability, and validity.

PubMed

Varni, James W; Burwinkle, Tasha M; Seid, Michael

2006-03-01

The application of health-related quality of life (HRQOL) as a school population health measure may facilitate risk assessment and resource allocation, the tracking of student health at the school and district level, the identification of health disparities among schoolchildren, and the determination of health outcomes from interventions and policy decisions at the school, district, and county level. To determine the feasibility, reliability, and validity of the 23-item PedsQL 4.0 (Pediatric Quality of Life Inventory) Generic Core Scales as a school population health measure for children and adolescents. Survey conducted in 304 classes at 18 elementary schools, 4 middle schools, and 3 high schools within a large metropolitan school district. The PedsQL 4.0 Generic Core Scales (Physical, Emotional, Social, School Functioning) were completed by 2437 children ages 8-18 and 4227 parents of children ages 5-18. The PedsQL 4.0 evidenced minimal missing responses, achieved excellent reliability for the Total Scale Score (alpha = 0.89 child, 0.92, parent report), and distinguished between healthy children and children with chronic health conditions. The PedsQL 4.0 was related to indicators of socioeconomic status (SES) at the school and district level. The PedsQL School Functioning Scale was significantly correlated with standardized achievement scores based on the Stanford 9. The results demonstrate the feasibility, reliability and validity of the PedsQL 4.0 Generic Core Scales as a school population health measure. The implications of measuring HRQOL in schoolchildren at the school, district, and county level for identifying and ameliorating health disparities are discussed.

Impacts of generic competition and benefit management practices on spending for prescription drugs: evidence from Medicare's Part D benefit.

PubMed

Sheingold, Steven; Nguyen, Nguyen Xuan

2014-01-01

This study estimates the effects of generic competition, increased cost-sharing, and benefit practices on utilization and spending for prescription drugs. We examined changes in Medicare price and utilization from 2007 to 2009 of all drugs in 28 therapeutic classes. The classes accounted for 80% of Medicare Part D spending in 2009 and included the 6 protected classes and 6 classes with practically no generic competition. All variables were constructed to measure each drug relative to its class at a specific plan sponsor. We estimated that the shift toward generic utilization had cut in half the rate of increase in the price of a prescription during 2007-2009. Specifically, the results showed that (1) rapid generic penetration had significantly held down costs per prescription, (2) copayment and other benefit practices shifted utilization to generics and favored brands, and (3) price increases were generally greater in less competitive classes of drugs. In many ways, Part D was implemented at a fortuitous time; since 2006, there have been relatively few new blockbuster drugs introduced, and many existing high-volume drugs used by beneficiaries were in therapeutic classes with multiple brands and generic alternatives. Under these conditions, our paper showed that plan sponsors have been able to contain costs by encouraging use of generics or drugs offering greater value within therapeutic classes. It is less clear what will happen to future Part D costs if a number of new and effective drugs for beneficiaries enter the market with no real competitors.

Comparison of adherence to generic multi-tablet regimens vs. brand multi-tablet and brand single-tablet regimens likely to incorporate generic antiretroviral drugs by breaking or not fixed-dose combinations in HIV-infected patients.

PubMed

Rwagitinywa, Joseph; Lapeyre-Mestre, Maryse; Bourrel, Robert; Montastruc, Jean-Louis; Sommet, Agnès

2018-03-05

Adherence to antiretroviral (ARV) is crucial to achieve viral load suppression in HIV-infected patients. This study aimed to compare adherence to generic multi-tablet regimens (MTR) vs. brand MTR likely to incorporate ARV drugs without breaking fixed-dose combinations (FDC) and brand single-tablet regimens (STR) likely to incorporate generics by breaking the FDC. Patients aged of 18 years or over exposed to one of the generic or the brand of lamivudine (3TC), zidovudine/lamivudine (AZT/TC), nevirapine (NVP), or efavirenz (EFV), or the brand STR of efavirenz/emtricitabine/tenofovir (EFV/FTC/TDF). Adherence was measured by medication possession ratio (MPR) using both defined daily dose (DDD) and daily number of tablet recommended for adults (DNT). Adherence to generic MTR vs. brand MTR and brand STR was compared using Kruskal-Wallis. The overall median adherence was 0.97 (IQR 0.13) by DNT method and 0.97 (0.14) by DDD method. Adherence in patients exposed to generic MTR (n = 165) vs. brand MTR (n = 481) and brand STR (n = 470) was comparable by DNT and DDD methods. In conclusion, adherence to generic MTR was high and comparable with adherence to brand MTR and to STR. Utilization of DDD instead DNT to measure the MPR led to small but nonsignificant difference that has no clinical impact. © 2018 Société Française de Pharmacologie et de Thérapeutique.

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.

Multiplex networks in metropolitan areas: generic features and local effects.

PubMed

Strano, Emanuele; Shai, Saray; Dobson, Simon; Barthelemy, Marc

2015-10-06

Most large cities are spanned by more than one transportation system. These different modes of transport have usually been studied separately: it is however important to understand the impact on urban systems of coupling different modes and we report in this paper an empirical analysis of the coupling between the street network and the subway for the two large metropolitan areas of London and New York. We observe a similar behaviour for network quantities related to quickest paths suggesting the existence of generic mechanisms operating beyond the local peculiarities of the specific cities studied. An analysis of the betweenness centrality distribution shows that the introduction of underground networks operate as a decentralizing force creating congestion in places located at the end of underground lines. Also, we find that increasing the speed of subways is not always beneficial and may lead to unwanted uneven spatial distributions of accessibility. In fact, for London—but not for New York—there is an optimal subway speed in terms of global congestion. These results show that it is crucial to consider the full, multimodal, multilayer network aspects of transportation systems in order to understand the behaviour of cities and to avoid possible negative side-effects of urban planning decisions. © 2015 The Author(s).

Multiplex networks in metropolitan areas: generic features and local effects

PubMed Central

Strano, Emanuele; Shai, Saray; Dobson, Simon; Barthelemy, Marc

2015-01-01

Most large cities are spanned by more than one transportation system. These different modes of transport have usually been studied separately: it is however important to understand the impact on urban systems of coupling different modes and we report in this paper an empirical analysis of the coupling between the street network and the subway for the two large metropolitan areas of London and New York. We observe a similar behaviour for network quantities related to quickest paths suggesting the existence of generic mechanisms operating beyond the local peculiarities of the specific cities studied. An analysis of the betweenness centrality distribution shows that the introduction of underground networks operate as a decentralizing force creating congestion in places located at the end of underground lines. Also, we find that increasing the speed of subways is not always beneficial and may lead to unwanted uneven spatial distributions of accessibility. In fact, for London—but not for New York—there is an optimal subway speed in terms of global congestion. These results show that it is crucial to consider the full, multimodal, multilayer network aspects of transportation systems in order to understand the behaviour of cities and to avoid possible negative side-effects of urban planning decisions. PMID:26400198

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

76 FR 75809 - Prior Label Approval System: Generic Label Approval

Federal Register 2010, 2011, 2012, 2013, 2014

2011-12-05

... tracking and reporting systems; and (4) design and implement a survey of the effects of the limited generic... and poultry product inspection programs designed to assure consumers that meat and poultry products... mandatory features are designed to ensure that meat and poultry products are accurately and truthfully...

ORE's GENeric Evaluation SYStem: GENESYS 1988-89.

ERIC Educational Resources Information Center

Baenen, Nancy; And Others

GENESYS--GENeric Evaluation SYStem--is a method of streamlining data collection and evaluation through the use of computer technology. GENESYS has allowed the Office of Research and Evaluation (ORE) of the Austin (Texas) Independent School District to evaluate a multitude of contrasting programs with limited resources. By standardizing methods and…

Lack of broad functional differences in immunity in fully vaccinated vs. unvaccinated children.

PubMed

Sherrid, Ashley M; Ruck, Candice E; Sutherland, Darren; Cai, Bing; Kollmann, Tobias R

2017-04-01

Concerns have been raised that with an increase in the number of vaccines administered early in life, immune development could be altered, leading to either increased or decreased immune reactivity. We investigated the impact of vaccination on immune status, contrasting the immune response to general, nonantigen-specific stimuli in a cohort of entirely unvaccinated vs. fully vaccinated children at 3-5 y of age. Innate immunity was assessed by quantifying bulk and cell-type-specific cytokine production in response to stimulation with pathogen associated microbial patterns. Adaptive immune status was characterized by assessing lymphocyte proliferation and cytokine production in response to generic T cell stimuli. Our investigations failed to reveal a broadly evident alteration of either innate or adaptive immunity in vaccinated children. Equivalently robust innate and adaptive responses to pathogen associated microbial patterns and generic T cell stimulants were observed in both groups. Although our sample size was small, our data suggest that standard childhood vaccinations do not lead to long-lasting gross alterations of the immune system.

On the stabilizability of multivariable systems by minimum order compensation

NASA Technical Reports Server (NTRS)

Byrnes, C. I.; Anderson, B. D. O.

1983-01-01

In this paper, a derivation is provided of the necessary condition, mp equal to or greater than n, for stabilizability by constant gain feedback of the generic degree n, p x m system. This follows from another of the main results, which asserts that generic stabilizability is equivalent to generic solvability of a deadbeat control problem, provided mp equal to or less than n. Taken together, these conclusions make it possible to make some sharp statements concerning minimum order stabilization. The techniques are primarily drawn from decision algebra and classical algebraic geometry and have additional consequences for problems of stabilizability and pole-assignability. Among these are the decidability (by a Sturm test) of the equivalence of generic pole-assignability and generic stabilizability, the semi-algebraic nature of the minimum order, q, of a stabilizing compensator, and the nonexistence of formulae involving rational operations and extraction of square roots for pole-assigning gains when they exist, answering in the negative a question raised by Anderson, Bose, and Jury (1975).

How does the past of a soccer match influence its future? Concepts and statistical analysis.

PubMed

Heuer, Andreas; Rubner, Oliver

2012-01-01

Scoring goals in a soccer match can be interpreted as a stochastic process. In the most simple description of a soccer match one assumes that scoring goals follows from independent rate processes of both teams. This would imply simple Poissonian and Markovian behavior. Deviations from this behavior would imply that the previous course of the match has an impact on the present match behavior. Here a general framework for the identification of deviations from this behavior is presented. For this endeavor it is essential to formulate an a priori estimate of the expected number of goals per team in a specific match. This can be done based on our previous work on the estimation of team strengths. Furthermore, the well-known general increase of the number of the goals in the course of a soccer match has to be removed by appropriate normalization. In general, three different types of deviations from a simple rate process can exist. First, the goal rate may depend on the exact time of the previous goals. Second, it may be influenced by the time passed since the previous goal and, third, it may reflect the present score. We show that the Poissonian scenario is fulfilled quite well for the German Bundesliga. However, a detailed analysis reveals significant deviations for the second and third aspect. Dramatic effects are observed if the away team leads by one or two goals in the final part of the match. This analysis allows one to identify generic features about soccer matches and to learn about the hidden complexities behind scoring goals. Among others the reason for the fact that the number of draws is larger than statistically expected can be identified.

How Does the Past of a Soccer Match Influence Its Future? Concepts and Statistical Analysis

PubMed Central

Heuer, Andreas; Rubner, Oliver

2012-01-01

Scoring goals in a soccer match can be interpreted as a stochastic process. In the most simple description of a soccer match one assumes that scoring goals follows from independent rate processes of both teams. This would imply simple Poissonian and Markovian behavior. Deviations from this behavior would imply that the previous course of the match has an impact on the present match behavior. Here a general framework for the identification of deviations from this behavior is presented. For this endeavor it is essential to formulate an a priori estimate of the expected number of goals per team in a specific match. This can be done based on our previous work on the estimation of team strengths. Furthermore, the well-known general increase of the number of the goals in the course of a soccer match has to be removed by appropriate normalization. In general, three different types of deviations from a simple rate process can exist. First, the goal rate may depend on the exact time of the previous goals. Second, it may be influenced by the time passed since the previous goal and, third, it may reflect the present score. We show that the Poissonian scenario is fulfilled quite well for the German Bundesliga. However, a detailed analysis reveals significant deviations for the second and third aspect. Dramatic effects are observed if the away team leads by one or two goals in the final part of the match. This analysis allows one to identify generic features about soccer matches and to learn about the hidden complexities behind scoring goals. Among others the reason for the fact that the number of draws is larger than statistically expected can be identified. PMID:23226200

Economic evaluation in short bowel syndrome (SBS): an algorithm to estimate utility scores for a patient-reported SBS-specific quality of life scale (SBS-QoL™).

PubMed

Lloyd, Andrew; Kerr, Cicely; Breheny, Katie; Brazier, John; Ortiz, Aurora; Borg, Emma

2014-03-01

Condition-specific preference-based measures can offer utility data where they would not otherwise be available or where generic measures may lack sensitivity, although they lack comparability across conditions. This study aimed to develop an algorithm for estimating utilities from the short bowel syndrome health-related quality of life scale (SBS-QoL™). SBS-QoL™ items were selected based on factor and item performance analysis of a European SBS-QoL™ dataset and consultation with 3 SBS clinical experts. Six-dimension health states were developed using 8 SBS-QoL™ items (2 dimensions combined 2 SBS-QoL™ items). SBS health states were valued by a UK general population sample (N = 250) using the lead-time time trade-off method. Preference weights or 'utility decrements' for each severity level of each dimension were estimated by regression models and used to develop the scoring algorithm. Mean utilities for the SBS health states ranged from -0.46 (worst health state, very much affected on all dimensions) to 0.92 (best health state, not at all affected on all dimensions). The random effects model with maximum likelihood estimation regression had the best predictive ability and lowest root mean squared error and mean absolute error, and was used to develop the scoring algorithm. The preference-weighted scoring algorithm for the SBS-QoL™ developed is able to estimate a wide range of utility values from patient-level SBS-QoL™ data. This allows estimation of SBS HRQL impact for the purpose of economic evaluation of SBS treatment benefits.

Oral health-related quality of life in primary Sjögren's syndrome.

PubMed

Fernández-Martínez, Gladyz; Zamora-Legoff, Víctor; Hernández Molina, Gabriela

2018-05-10

To assess health-related quality of life (HRQoL) and oral health-related quality of life, and correlate them with unstimulated whole salivary flow (UWSF) and oral sicca symptoms in patients with primary Sjögren's syndrome (PSS). We included 60 patients with PSS and 60 healthy controls matched according to gender and age (±3 years). We measured the UWSF and scored the European League Against Rheumatism (EULAR) Sjögren's Syndrome Patient Reported Index (ESSPRI). We assessed the short version of the SF-36 as a generic measurement of HRQoL and the Xerostomia Quality of Life Scale (XeQoLS) questionnaire to evaluate oral quality of life. We evaluated oral symptoms using an 8-item Visual Analogue Scale (VAS) questionnaire. We observed a poorer HRQoL (lower scores in SF-36) and oral quality of life (higher scores in XeQoLS), as well as a greater severity of symptoms in the VAS questionnaire upon comparing patients vs. controls. The XeQoL correlated with the UWSF (τ = -0.24, P = .008), the ESSPRI (τ =0.45, P = .0001), VAS 1-2 and VAS 5-8 and the SF-36 score (τ = -0.28, P = .002). Patients with PSS had a poorer HRQoL and oral quality of life than controls. UWSF contributes to the oral quality of life which, in turn, has an impact on HRQoL. Symptomatic treatment of xerostomia as well as the prevention of infections, decay and tooth loss would help to improve the oral quality of life in these patients. Copyright © 2018 Sociedad Española de Reumatología y Colegio Mexicano de Reumatología. Publicado por Elsevier España, S.L.U. All rights reserved.

Differences in Adverse Event Reporting Rates of Therapeutic Failure Between Two Once-daily Extended-release Methylphenidate Medications in Canada: Analysis of Spontaneous Adverse Event Reporting Databases.

PubMed

Park-Wyllie, Laura; van Stralen, Judy; Castillon, Genaro; Sherman, Stephen E; Almagor, Doron

2017-10-01

Our study evaluated adverse events of therapeutic failure (and specifically reduced duration of action) with the use of a branded product, Osmotic Release Oral System (OROS) methylphenidate, which is approved for the treatment of attention deficit/hyperactivity disorder, and a generic product (methylphenidate, methylphenidate ER-C), which was approved for marketing in Canada based on bioequivalence to OROS methylphenidate. This study was initiated following reports that some US-marketed generic methylphenidate ER products had substantially higher reporting rates of therapeutic failure than did the referenced brands. Through methodology similar to that used by the US Food and Drug Administration to investigate the issue with the US-marketed generic, reporting rates were calculated from cases of therapeutic failure identified in the Canadian Vigilance Adverse Reaction Online database for a 1-year period beginning 8 months after each product launch. Corresponding population exposure was estimated from the number of tablets dispensed. An in-depth analysis of narratives of individual case safety reports (ICSRs) with the use of the generic product was conducted in duplicate by 2 physicians to assess causality and to characterize the potential safety risk and clinical pattern of therapeutic failure. Similar secondary analyses were conducted on the US-marketed products. Reporting rates of therapeutic failure with the use of methylphenidate ER-C (generic) and OROS methylphenidate (brand name) were 411.5 and 37.5 cases per 100,000 patient-years, respectively (reporting rate ratio, 10.99; 95% CI, 5.93-22.21). In-depth analysis of narratives of 230 ICSRs of therapeutic failure with the Canadian-marketed generic determined that all ICSRs were either probably (60 [26%]) or possibly (170 [74%]) causally related to methylphenidate ER-C. Clinical symptoms suggestive of overdose were present in 31 reports of loss of efficacy (13.5%) and occurred primarily in the morning, and premature loss of efficacy (shorter duration of action) was described in 98 cases (42.6%) and occurred primarily in the afternoon. Impacts on social functioning, such as disruption in work or school performance or adverse social behaviors, were found in 51 cases (22.2%). The ~10-fold higher reporting rate of therapeutic failure with the generic product relative to its reference product in the present Canadian study resembles findings with US-marketed generic products. While these results should be interpreted with caution due to the limitations of spontaneous adverse event reporting, which may confound comparisons across products, similar findings nonetheless led the US Food and Drug Administration to declare in 2014 that 2 methylphenidate ER generic products in the United States were neither bioequivalent nor interchangeable with OROS methylphenidate-their reference product. Our results indicate a potential safety issue with the Canadian-marketed generic and suggest a need for further investigation by Health Canada. Copyright © 2017 The Authors. Published by Elsevier Inc. All rights reserved.

Predictors of generic substitution: The role of psychological, sociodemographic, and contextual factors.

PubMed

Drozdowska, Aleksandra; Hermanowski, Tomasz

2016-01-01

Escalating pharmaceutical costs have become a global challenge for both governments and patients. Generic substitution is one way of decreasing these costs. The aim of this study was to investigate factors associated with patients' choice between generic drugs and innovator drugs. The survey was conducted in June 2013, 1000 people from across Poland were chosen as a representative population sample. The outcome (a preference for generics/a preference for innovator pharmaceuticals/no preference) was modeled by multinomial logistic regression, adjusted for several variables describing patients' sensitivity to selected generic features (price, brand, and country of origin), to third-party opinions about generics (information on generics in the mass media, opinions of health professionals (i.e. physicians, pharmacists), relatives/friends), as well as patients' personal experiences and income per household. The results supported the predictive capacity of most independent variables (except for patient sensitivity to the country of origin and to the information on generics in the mass media), denoting patients' preferences toward generic substitution. Patient sensitivity to recommendations by physicians, generic brand, and household income were the strongest predictors of the choice between generic and innovator pharmaceuticals (P < 0.001). The probability of choosing generics over innovator drugs was significantly higher among respondents with the lowest income levels, in those who were indifferent to generic brand or their physician's opinion, as well as in respondents who were sensitive to recommendations by pharmacists or attached a greater value to a past experience with generics (their own experience or that of relatives/friends). In consideration of the foregoing, awareness-raising campaigns may be recommended, supported by a variety of systemic solutions and tools to encourage generic substitution. Copyright © 2016 Elsevier Inc. All rights reserved.

Construct validity of the individual work performance questionnaire.

PubMed

Koopmans, Linda; Bernaards, Claire M; Hildebrandt, Vincent H; de Vet, Henrica C W; van der Beek, Allard J

2014-03-01

To examine the construct validity of the Individual Work Performance Questionnaire (IWPQ). A total of 1424 Dutch workers from three occupational sectors (blue, pink, and white collar) participated in the study. First, IWPQ scores were correlated with related constructs (convergent validity). Second, differences between known groups were tested (discriminative validity). First, IWPQ scores correlated weakly to moderately with absolute and relative presenteeism, and work engagement. Second, significant differences in IWPQ scores were observed for workers differing in job satisfaction, and workers differing in health. Overall, the results indicate acceptable construct validity of the IWPQ. Researchers are provided with a reliable and valid instrument to measure individual work performance comprehensively and generically, among workers from different occupational sectors, with and without health problems.

Requirements analysis notebook for the flight data systems definition in the Real-Time Systems Engineering Laboratory (RSEL)

NASA Astrophysics Data System (ADS)

Wray, Richard B.

1991-12-01

A hybrid requirements analysis methodology was developed, based on the practices actually used in developing a Space Generic Open Avionics Architecture. During the development of this avionics architecture, a method of analysis able to effectively define the requirements for this space avionics architecture was developed. In this methodology, external interfaces and relationships are defined, a static analysis resulting in a static avionics model was developed, operating concepts for simulating the requirements were put together, and a dynamic analysis of the execution needs for the dynamic model operation was planned. The systems engineering approach was used to perform a top down modified structured analysis of a generic space avionics system and to convert actual program results into generic requirements. CASE tools were used to model the analyzed system and automatically generate specifications describing the model's requirements. Lessons learned in the use of CASE tools, the architecture, and the design of the Space Generic Avionics model were established, and a methodology notebook was prepared for NASA. The weaknesses of standard real-time methodologies for practicing systems engineering, such as Structured Analysis and Object Oriented Analysis, were identified.

Requirements analysis notebook for the flight data systems definition in the Real-Time Systems Engineering Laboratory (RSEL)

NASA Technical Reports Server (NTRS)

Wray, Richard B.

1991-01-01

A hybrid requirements analysis methodology was developed, based on the practices actually used in developing a Space Generic Open Avionics Architecture. During the development of this avionics architecture, a method of analysis able to effectively define the requirements for this space avionics architecture was developed. In this methodology, external interfaces and relationships are defined, a static analysis resulting in a static avionics model was developed, operating concepts for simulating the requirements were put together, and a dynamic analysis of the execution needs for the dynamic model operation was planned. The systems engineering approach was used to perform a top down modified structured analysis of a generic space avionics system and to convert actual program results into generic requirements. CASE tools were used to model the analyzed system and automatically generate specifications describing the model's requirements. Lessons learned in the use of CASE tools, the architecture, and the design of the Space Generic Avionics model were established, and a methodology notebook was prepared for NASA. The weaknesses of standard real-time methodologies for practicing systems engineering, such as Structured Analysis and Object Oriented Analysis, were identified.

Using time-series intervention analysis to understand U.S. Medicaid expenditures on antidepressant agents.

PubMed

Ferrand, Yann; Kelton, Christina M L; Guo, Jeff J; Levy, Martin S; Yu, Yan

2011-03-01

Medicaid programs' spending on antidepressants increased from $159 million in 1991 to $2 billion in 2005. The National Institute for Health Care Management attributed this expenditure growth to increases in drug utilization, entry of newer higher-priced antidepressants, and greater prescription drug insurance coverage. Rising enrollment in Medicaid has also contributed to this expenditure growth. This research examines the impact of specific events, including branded-drug and generic entry, a black box warning, direct-to-consumer advertising (DTCA), and new indication approval, on Medicaid spending on antidepressants. Using quarterly expenditure data for 1991-2005 from the national Medicaid pharmacy claims database maintained by the Centers for Medicare and Medicaid Services, a time-series autoregressive integrated moving average (ARIMA) intervention analysis was performed on 6 specific antidepressant drugs and on overall antidepressant spending. Twenty-nine potentially relevant interventions and their dates of occurrence were identified from the literature. Each was tested for an impact on the time series. Forecasts from the models were compared with a holdout sample of actual expenditure data. Interventions with significant impacts on Medicaid expenditures included the patent expiration of Prozac® (P<0.01) and the entry of generic paroxetine producers (P=0.04), which reduced expenditures on Prozac® and Paxil®, respectively, and the 1997 increase in DTCA (P=0.05), which increased spending on Wellbutrin®. Except for Paxil®, the ARIMA models had low prediction errors. Generic entry at the aggregate level did not lead to a reduction in overall expenditures (P>0.05), implying that the expanding market for antidepressants overwhelmed the effect of generic competition. Copyright © 2011 Elsevier Inc. All rights reserved.

Pharmaceutical expenditure forecast model to support health policy decision making.

PubMed

Rémuzat, Cécile; Urbinati, Duccio; Kornfeld, Åsa; Vataire, Anne-Lise; Cetinsoy, Laurent; Aballéa, Samuel; Mzoughi, Olfa; Toumi, Mondher

2014-01-01

With constant incentives for healthcare payers to contain their pharmaceutical budgets, modelling policy decision impact became critical. The objective of this project was to test the impact of various policy decisions on pharmaceutical budget (developed for the European Commission for the project 'European Union (EU) Pharmaceutical expenditure forecast' - http://ec.europa.eu/health/healthcare/key_documents/index_en.htm). A model was built to assess policy scenarios' impact on the pharmaceutical budgets of seven member states of the EU, namely France, Germany, Greece, Hungary, Poland, Portugal, and the United Kingdom. The following scenarios were tested: expanding the UK policies to EU, changing time to market access, modifying generic price and penetration, shifting the distribution chain of biosimilars (retail/hospital). Applying the UK policy resulted in dramatic savings for Germany (10 times the base case forecast) and substantial additional savings for France and Portugal (2 and 4 times the base case forecast, respectively). Delaying time to market was found be to a very powerful tool to reduce pharmaceutical expenditure. Applying the EU transparency directive (6-month process for pricing and reimbursement) increased pharmaceutical expenditure for all countries (from 1.1 to 4 times the base case forecast), except in Germany (additional savings). Decreasing the price of generics and boosting the penetration rate, as well as shifting distribution of biosimilars through hospital chain were also key methods to reduce pharmaceutical expenditure. Change in the level of reimbursement rate to 100% in all countries led to an important increase in the pharmaceutical budget. Forecasting pharmaceutical expenditure is a critical exercise to inform policy decision makers. The most important leverages identified by the model on pharmaceutical budget were driven by generic and biosimilar prices, penetration rate, and distribution. Reducing, even slightly, the prices of generics had a major impact on savings. However, very aggressive pricing of generic and biosimilar products might make this market unattractive and can be counterproductive. Worth noting, delaying time to access innovative products was also identified as an effective leverage to increase savings but might not be a desirable policy for breakthrough products. Increasing patient financial contributions, either directly or indirectly via their private insurances, is a more likely scenario rather than expanding the national pharmaceutical expenditure coverage.

Pharmaceutical expenditure forecast model to support health policy decision making

PubMed Central

Rémuzat, Cécile; Urbinati, Duccio; Kornfeld, Åsa; Vataire, Anne-Lise; Cetinsoy, Laurent; Aballéa, Samuel; Mzoughi, Olfa; Toumi, Mondher

2014-01-01

Background and objective With constant incentives for healthcare payers to contain their pharmaceutical budgets, modelling policy decision impact became critical. The objective of this project was to test the impact of various policy decisions on pharmaceutical budget (developed for the European Commission for the project ‘European Union (EU) Pharmaceutical expenditure forecast’ – http://ec.europa.eu/health/healthcare/key_documents/index_en.htm). Methods A model was built to assess policy scenarios’ impact on the pharmaceutical budgets of seven member states of the EU, namely France, Germany, Greece, Hungary, Poland, Portugal, and the United Kingdom. The following scenarios were tested: expanding the UK policies to EU, changing time to market access, modifying generic price and penetration, shifting the distribution chain of biosimilars (retail/hospital). Results Applying the UK policy resulted in dramatic savings for Germany (10 times the base case forecast) and substantial additional savings for France and Portugal (2 and 4 times the base case forecast, respectively). Delaying time to market was found be to a very powerful tool to reduce pharmaceutical expenditure. Applying the EU transparency directive (6-month process for pricing and reimbursement) increased pharmaceutical expenditure for all countries (from 1.1 to 4 times the base case forecast), except in Germany (additional savings). Decreasing the price of generics and boosting the penetration rate, as well as shifting distribution of biosimilars through hospital chain were also key methods to reduce pharmaceutical expenditure. Change in the level of reimbursement rate to 100% in all countries led to an important increase in the pharmaceutical budget. Conclusions Forecasting pharmaceutical expenditure is a critical exercise to inform policy decision makers. The most important leverages identified by the model on pharmaceutical budget were driven by generic and biosimilar prices, penetration rate, and distribution. Reducing, even slightly, the prices of generics had a major impact on savings. However, very aggressive pricing of generic and biosimilar products might make this market unattractive and can be counterproductive. Worth noting, delaying time to access innovative products was also identified as an effective leverage to increase savings but might not be a desirable policy for breakthrough products. Increasing patient financial contributions, either directly or indirectly via their private insurances, is a more likely scenario rather than expanding the national pharmaceutical expenditure coverage. PMID:27226830

75 FR 6065 - Extension of Public Comment Period on the Draft Environmental Impact Statement for the Moore...

Federal Register 2010, 2011, 2012, 2013, 2014

2010-02-05

... Environmental Impact Statement for the Moore Ranch In-Situ Recovery Project in Campbell County, WY; Supplement to the Generic Environmental Impact Statement for In-Situ Leach Uranium Milling Facilities AGENCY... Statement (Draft SEIS) for the Moore Ranch In-Situ Recovery (ISR) Project closes on February 1, 2010. The...

Examining patterns in medication documentation of trade and generic names in an academic family practice training centre.

PubMed

Summers, Alexander; Ruderman, Carly; Leung, Fok-Han; Slater, Morgan

2017-09-22

Studies in the United States have shown that physicians commonly use brand names when documenting medications in an outpatient setting. However, the prevalence of prescribing and documenting brand name medication has not been assessed in a clinical teaching environment. The purpose of this study was to describe the use of generic versus brand names for a select number of pharmaceutical products in clinical documentation in a large, urban academic family practice centre. A retrospective chart review of the electronic medical records of the St. Michael's Hospital Academic Family Health Team (SMHAFHT). Data for twenty commonly prescribed medications were collected from the Cumulative Patient Profile as of August 1, 2014. Each medication name was classified as generic or trade. Associations between documentation patterns and physician characteristics were assessed. Among 9763 patients prescribed any of the twenty medications of interest, 45% of patient charts contained trade nomenclature exclusively. 32% of charts contained only generic nomenclature, and 23% contained a mix of generic and trade nomenclature. There was large variation in use of generic nomenclature amongst physicians, ranging from 19% to 93%. Trade names in clinical documentation, which likely reflect prescribing habits, continue to be used abundantly in the academic setting. This may become part of the informal curriculum, potentially facilitating undue bias in trainees. Further study is needed to determine characteristics which influence use of generic or trade nomenclature and the impact of this trend on trainees' clinical knowledge and decision-making.

Exploring community pharmacists' views on generic medicines: a nationwide study from Malaysia.

PubMed

Chong, Chee Ping; Hassali, Mohamed Azmi; Bahari, Mohd Baidi; Shafie, Asrul Akmal

2011-02-01

To evaluate the Malaysian community pharmacists' views on generic medicines. A sample of 1419 Malaysian community pharmacies with resident pharmacists. A cross-sectional nationwide survey using a self-completed mailing questionnaire. Pharmacists' views on generic medicines including issues surrounding efficacy, safety, quality and bioequivalence. Responses were received from 219 pharmacies (response rate 15.4%). Only 50.2% of the surveyed pharmacists agreed that all products that are approved as generic equivalents can be considered therapeutically equivalent with the innovator medicines. Around 76% of respondents indicated that generic substitution of narrow therapeutic index medicines is inappropriate. The majority of the pharmacists understood that a generic medicine must contain the same amount of active ingredient (84.5%) and must be in the same dosage form as the innovator brand (71.7%). About 21% of respondents though that generic medicines are of inferior quality compared to innovator medicines. Most of the pharmacists (61.6%) disagreed that generic medicines produce more side-effects than innovator brand. Pharmacists graduated from Malaysian universities, twinning program and overseas universities were not differed significantly in their views on generic medicines. Additionally, the respondents appeared to have difficulty in ascertaining the bioequivalent status of the marketed generic products in Malaysia. The Malaysian pharmacists' have lack of information and/or trust in the generic manufacturing and/or approval system in Malaysia. This issue should be addressed by pharmacy educators and relevant government agencies.

BRST theory without Hamiltonian and Lagrangian

NASA Astrophysics Data System (ADS)

Lyakhovich, S. L.; Sharapov, A. A.

2005-03-01

We consider a generic gauge system, whose physical degrees of freedom are obtained by restriction on a constraint surface followed by factorization with respect to the action of gauge transformations; in so doing, no Hamiltonian structure or action principle is supposed to exist. For such a generic gauge system we construct a consistent BRST formulation, which includes the conventional BV Lagrangian and BFV Hamiltonian schemes as particular cases. If the original manifold carries a weak Poisson structure (a bivector field giving rise to a Poisson bracket on the space of physical observables) the generic gauge system is shown to admit deformation quantization by means of the Kontsevich formality theorem. A sigma-model interpretation of this quantization algorithm is briefly discussed.

WWC Review of the Report "Incentives, Selection, and Teacher Performance: Evidence from IMPACT." What Works Clearinghouse Single Study Review

ERIC Educational Resources Information Center

What Works Clearinghouse, 2014

2014-01-01

The 2013 study, "Incentives, Selection, and Teacher Performance: Evidence from IMPACT" examined the effects of "IMPACT," a teacher evaluation system used in the District of Columbia Public Schools, on teacher retention and performance. "IMPACT" assigns each teacher a single performance score based on classroom…

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

Chen, S.; Peng, L.; Bronevetsky, G.

As HPC systems approach Exascale, their circuit feature will shrink, while their overall size will grow, all at a fixed power limit. These trends imply that soft faults in electronic circuits will become an increasingly significant problem for applications that run on these systems, causing them to occasionally crash or worse, silently return incorrect results. This is motivating extensive work on application resilience to such faults, ranging from generic techniques such as replication or checkpoint/restart to algorithm-specific error detection and resilience techniques. Effective use of such techniques requires a detailed understanding of (1) which vulnerable parts of the application aremore » most worth protecting (2) the performance and resilience impact of fault resilience mechanisms on the application. This paper presents FaultTelescope, a tool that combines these two and generates actionable insights by presenting in an intuitive way application vulnerabilities and impact of fault resilience mechanisms on applications.« less

EXPLORING PATENT ACTIVITY AND ITS POTENTIAL ASSOCIATION WITH HEALTHCARE OUTCOMES: A CASE STUDY OF OSTOMY PRODUCTS IN SWEDEN.

PubMed

Calara, Paul Samuel; Althin, Rikard; Inglese, Gary; Nichols, Thomas

2017-01-01

The aim of this study was to evaluate whether ostomy industry patent activity (PA) is associated with patient outcomes and healthcare costs. Two groups of ostomy pouch users based on manufacturer PA (low or high) were compared in terms of ostomy-related wear patterns, adverse events, and healthcare expenditure. Using Swedish registry data, all patients with newly formed stomas were divided between each group and were followed during a 2-year period (2011-12). Propensity score matching and parametric duration analysis were used to compare outcomes between patients of similar characteristics such as sex, age, and ostomy surgery type. In both one- and two-piece systems, the high PA group had significantly lower monthly ostomy-related expenditure than the low PA group (one-piece: 197.47 EUR versus 233.34 EUR; two-piece: 164.00 EUR versus 278.98 EUR). Fewer pouch and skin wafer purchases per month were an important driver of cost differences. Both groups had similar likelihood of purchasing dermatological products for skin complications over time. PA in the ostomy care industry was associated with reduced healthcare costs, but not necessarily with fewer skin complications. It suggests that there is a health economic benefit from products made by patent intensive companies which may differentiate them from generic comparators, but more research is needed to understand the impact of activities conducive to medical innovation on health outcomes.

The human orbitofrontal cortex monitors outcomes even when no reward is at stake.

PubMed

Schnider, Armin; Treyer, Valerie; Buck, Alfred

2005-01-01

The orbitofrontal cortex (OFC) processes the occurrence or omission of anticipated rewards, but clinical evidence suggests that it might serve as a generic outcome monitoring system, independent of tangible reward. In this positron emission tomography (PET) study, normal human subjects performed a series of tasks in which they simply had to predict behind which one of two colored rectangles a drawing of an object was hidden. While all tasks involved anticipation in that they had an expectation phase between the subject's prediction and the presentation of the outcome, they varied with regards to the uncertainty of outcome. No comment on the correctness of the prediction, no record of ongoing performance, and no reward, not even a score, was provided. Nonetheless, we found strong activation of the OFC: in comparison with a baseline task, the left anterior medial OFC showed activation in all conditions, indicating a basic role in anticipation; the left posterior OFC was activated in all tasks with some uncertainty of outcome, suggesting a role in the monitoring of outcomes; the right medial OFC showed activation exclusively during guessing. The data indicate a generic role of the human OFC, with some topical specificity, in the generation of hypotheses and processing of outcomes, independent of the presence of explicit reward.

A Preliminary Investigation into the Effect of Standards-Based Grading on the Academic Performance of African-American Students

NASA Astrophysics Data System (ADS)

Bradbury-Bailey, Mary

With the implementation of No Child Left Behind came a wave of educational reform intended for those working with student populations whose academic performance seemed to indicate an alienation from the educational process. Central to these reforms was the implementation of standards-based instruction and their accompanying standardized assessments; however, in one area reform seemed nonexistent---the teacher's gradebook. (Erickson, 2010, Marzano, 2006; Scriffiny, 2008). Given the link between the grading process and achievement motivation, Ames (1992) suggested the use of practices that promote mastery goal orientation. The purpose of this study was to examine the impact of standards-based grading system as a factor contributing to mastery goal orientation on the academic performance of urban African American students. To determine the degree of impact, this study first compared the course content averages and End-of-Course-Test (EOCT) scores for science classes using a traditional grading system to those using a standards-based grading system by employing an Analysis of Covariance (ANCOVA). While there was an increase in all grading areas, two showed a significant difference---the Physical Science course content average (p = 0.024) and ix the Biology EOCT scores (p = 0.0876). These gains suggest that standards-based grading can have a positive impact on the academic performance of African American students. Secondly, this study examined the correlation between the course content averages and the EOCT scores for both the traditional and standards-based grading system; for both Physical Science and Biology, there was a stronger correlation between these two scores for the standards-based grading system.

Real-Time Interactive Social Environments: A Review of BT's Generic Learning Platform.

ERIC Educational Resources Information Center

Gardner, Michael; Ward, Holly

1999-01-01

Describes the development of a generic learning platform for online distance learning and explains RISE (Real-time Interactive Social Environments), a Web-based system. Reports results of trials at the University of Hull Language Institute in an English as a Foreign Language course that investigated system usability, teacher roles, and student…

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.

Weighing of risk factors for penetrating keratoplasty graft failure: application of Risk Score System.

PubMed

Tourkmani, Abdo Karim; Sánchez-Huerta, Valeria; De Wit, Guillermo; Martínez, Jaime D; Mingo, David; Mahillo-Fernández, Ignacio; Jiménez-Alfaro, Ignacio

2017-01-01

To analyze the relationship between the score obtained in the Risk Score System (RSS) proposed by Hicks et al with penetrating keratoplasty (PKP) graft failure at 1y postoperatively and among each factor in the RSS with the risk of PKP graft failure using univariate and multivariate analysis. The retrospective cohort study had 152 PKPs from 152 patients. Eighteen cases were excluded from our study due to primary failure (10 cases), incomplete medical notes (5 cases) and follow-up less than 1y (3 cases). We included 134 PKPs from 134 patients stratified by preoperative risk score. Spearman coefficient was calculated for the relationship between the score obtained and risk of failure at 1y. Univariate and multivariate analysis were calculated for the impact of every single risk factor included in the RSS over graft failure at 1y. Spearman coefficient showed statistically significant correlation between the score in the RSS and graft failure ( P <0.05). Multivariate logistic regression analysis showed no statistically significant relationship ( P >0.05) between diagnosis and lens status with graft failure. The relationship between the other risk factors studied and graft failure was significant ( P <0.05), although the results for previous grafts and graft failure was unreliable. None of our patients had previous blood transfusion, thus, it had no impact. After the application of multivariate analysis techniques, some risk factors do not show the expected impact over graft failure at 1y.

Weighing of risk factors for penetrating keratoplasty graft failure: application of Risk Score System

PubMed Central

Tourkmani, Abdo Karim; Sánchez-Huerta, Valeria; De Wit, Guillermo; Martínez, Jaime D.; Mingo, David; Mahillo-Fernández, Ignacio; Jiménez-Alfaro, Ignacio

2017-01-01

AIM To analyze the relationship between the score obtained in the Risk Score System (RSS) proposed by Hicks et al with penetrating keratoplasty (PKP) graft failure at 1y postoperatively and among each factor in the RSS with the risk of PKP graft failure using univariate and multivariate analysis. METHODS The retrospective cohort study had 152 PKPs from 152 patients. Eighteen cases were excluded from our study due to primary failure (10 cases), incomplete medical notes (5 cases) and follow-up less than 1y (3 cases). We included 134 PKPs from 134 patients stratified by preoperative risk score. Spearman coefficient was calculated for the relationship between the score obtained and risk of failure at 1y. Univariate and multivariate analysis were calculated for the impact of every single risk factor included in the RSS over graft failure at 1y. RESULTS Spearman coefficient showed statistically significant correlation between the score in the RSS and graft failure (P<0.05). Multivariate logistic regression analysis showed no statistically significant relationship (P>0.05) between diagnosis and lens status with graft failure. The relationship between the other risk factors studied and graft failure was significant (P<0.05), although the results for previous grafts and graft failure was unreliable. None of our patients had previous blood transfusion, thus, it had no impact. CONCLUSION After the application of multivariate analysis techniques, some risk factors do not show the expected impact over graft failure at 1y. PMID:28393027

Architecture design of a generic centralized adjudication module integrated in a web-based clinical trial management system

PubMed Central

Zhao, Wenle; Pauls, Keith

2015-01-01

Background Centralized outcome adjudication has been used widely in multi-center clinical trials in order to prevent potential biases and to reduce variations in important safety and efficacy outcome assessments. Adjudication procedures could vary significantly among different studies. In practice, the coordination of outcome adjudication procedures in many multicenter clinical trials remains as a manual process with low efficiency and high risk of delay. Motivated by the demands from two large clinical trial networks, a generic outcome adjudication module has been developed by the network’s data management center within a homegrown clinical trial management system. In this paper, the system design strategy and database structure are presented. Methods A generic database model was created to transfer different adjudication procedures into a unified set of sequential adjudication steps. Each adjudication step was defined by one activate condition, one lock condition, one to five categorical data items to capture adjudication results, and one free text field for general comments. Based on this model, a generic outcome adjudication user interface and a generic data processing program were developed within a homegrown clinical trial management system to provide automated coordination of outcome adjudication. Results By the end of 2014, this generic outcome adjudication module had been implemented in 10 multicenter trials. A total of 29 adjudication procedures were defined with the number of adjudication steps varying from 1 to 7. The implementation of a new adjudication procedure in this generic module took an experienced programmer one or two days. A total of 7,336 outcome events had been adjudicated and 16,235 adjudication step activities had been recorded. In a multicenter trial, 1144 safety outcome event submissions went through a three-step adjudication procedure and reported a median of 3.95 days from safety event case report form submission to adjudication completion. In another trial, 277 clinical outcome events were adjudicated by a six-step procedure and took a median of 23.84 days from outcome event case report form submission to adjudication procedure completion. Conclusions A generic outcome adjudication module integrated in the clinical trial management system made the automated coordination of efficacy and safety outcome adjudication a reality. PMID:26464429

The Generic Data Capture Facility

NASA Technical Reports Server (NTRS)

Connell, Edward B.; Barnes, William P.; Stallings, William H.

1987-01-01

The Generic Data Capture Facility, which can provide data capture support for a variety of different types of spacecraft while enabling operations costs to be carefully controlled, is discussed. The data capture functions, data protection, isolation of users from data acquisition problems, data reconstruction, and quality and accounting are addressed. The TDM and packet data formats utilized by the system are described, and the development of generic facilities is considered.

Patterns in spontaneous adverse event reporting among branded and generic antiepileptic drugs.

PubMed

Bohn, J; Kortepeter, C; Muñoz, M; Simms, K; Montenegro, S; Dal Pan, G

2015-05-01

Spontaneous adverse event reports constitute an important source of information on previously unknown adverse reactions to marketed medicines. However, the dynamics of such reporting following generic introduction are poorly understood. Using adverse event reports on five antiepileptic drugs from the US Food and Drug Administration's Adverse Event Reporting System, we describe temporal trends in adverse event reporting before and after generic introduction, and survey the quality of product-identifying information contained therein. The majority of reports were sent by innovator drug manufacturers while few were sent by generic manufacturers, even when generics accounted for >90% of dispensed prescriptions. We manually reviewed narratives from 2,500 reports and found that the suspect product type (brand or generic) could not be determined in 84% of reports, while generic products (16%) were identified more often than brand-name products (<1%). These results suggest that pharmacovigilance stakeholders should act to promote more detailed reporting practices. © 2015 American Society for Clinical Pharmacology and Therapeutics.

An avionics scenario and command model description for Space Generic Open Avionics Architecture (SGOAA)

NASA Technical Reports Server (NTRS)

Stovall, John R.; Wray, Richard B.

1994-01-01

This paper presents a description of a model for a space vehicle operational scenario and the commands for avionics. This model will be used in developing a dynamic architecture simulation model using the Statemate CASE tool for validation of the Space Generic Open Avionics Architecture (SGOAA). The SGOAA has been proposed as an avionics architecture standard to NASA through its Strategic Avionics Technology Working Group (SATWG) and has been accepted by the Society of Automotive Engineers (SAE) for conversion into an SAE Avionics Standard. This architecture was developed for the Flight Data Systems Division (FDSD) of the NASA Johnson Space Center (JSC) by the Lockheed Engineering and Sciences Company (LESC), Houston, Texas. This SGOAA includes a generic system architecture for the entities in spacecraft avionics, a generic processing external and internal hardware architecture, and a nine class model of interfaces. The SGOAA is both scalable and recursive and can be applied to any hierarchical level of hardware/software processing systems.

Multivariable control of a forward swept wing aircraft. M.S. Thesis

NASA Technical Reports Server (NTRS)

Quinn, W. W.

1986-01-01

The impact of independent canard and flaperon control of the longitudinal axis of a generic forward swept wing aircraft is examined. The Linear Quadratic Gaussian (LQG)/Loop Transfer Recovery (LTR) method is used to design three compensators: two single-input-single-output (SISO) systems, one with angle of attack as output and canard as control, the other with pitch attitude as output and canard as control, and a two-input-two-output system with both canard and flaperon controlling both the pitch attitude and angle of attack. The performances of the three systems are compared showing the addition of flaperon control allows the aircraft to perform in the precision control modes with very little loss of command following accuracy.

Performance dependence of hybrid x-ray computed tomography/fluorescence molecular tomography on the optical forward problem.

PubMed

Hyde, Damon; Schulz, Ralf; Brooks, Dana; Miller, Eric; Ntziachristos, Vasilis

2009-04-01

Hybrid imaging systems combining x-ray computed tomography (CT) and fluorescence tomography can improve fluorescence imaging performance by incorporating anatomical x-ray CT information into the optical inversion problem. While the use of image priors has been investigated in the past, little is known about the optimal use of forward photon propagation models in hybrid optical systems. In this paper, we explore the impact on reconstruction accuracy of the use of propagation models of varying complexity, specifically in the context of these hybrid imaging systems where significant structural information is known a priori. Our results demonstrate that the use of generically known parameters provides near optimal performance, even when parameter mismatch remains.

Pharmaceutical quality of seven generic Levodopa/Benserazide products compared with original Madopar® / Prolopa®

PubMed Central

2013-01-01

Background By definition, a generic product is considered interchangeable with the innovator brand product. Controversy exists about interchangeability, and attention is predominantly directed to contaminants. In particular for chronic, degenerative conditions such as in Parkinson’s disease (PD) generic substitution remains debated among physicians, patients and pharmacists. The objective of this study was to compare the pharmaceutical quality of seven generic levodopa/benserazide hydrochloride combination products marketed in Germany with the original product (Madopar® / Prolopa® 125, Roche, Switzerland) in order to evaluate the potential impact of Madopar® generics versus branded products for PD patients and clinicians. Methods Madopar® / Prolopa® 125 tablets and capsules were used as reference material. The generic products tested (all 100 mg/25 mg formulations) included four tablet and three capsule formulations. Colour, appearance of powder (capsules), disintegration and dissolution, mass of tablets and fill mass of capsules, content, identity and amounts of impurities were assessed along with standard physical and chemical laboratory tests developed and routinely practiced at Roche facilities. Results were compared to the original “shelf-life” specifications in use by Roche. Results Each of the seven generic products had one or two parameters outside the specifications. Deviations for the active ingredients ranged from +8.4% (benserazide) to −7.6% (levodopa) in two tablet formulations. Degradation products were measured in marked excess (+26.5%) in one capsule formulation. Disintegration time and dissolution for levodopa and benserazide hydrochloride at 30 min were within specifications for all seven generic samples analysed, however with some outliers. Conclusions Deviations for the active ingredients may go unnoticed by a new user of the generic product, but may entail clinical consequences when switching from original to generic during a long-term therapy. Degradation products may pose a safety concern. Our results should prompt caution when prescribing a generic of Madopar®/Prolopa®, and also invite to further investigations in view of a more comprehensive approach, both pharmaceutical and clinical. PMID:23617953

Candidate Mission from Planet Earth control and data delivery system architecture

NASA Technical Reports Server (NTRS)

Shapiro, Phillip; Weinstein, Frank C.; Hei, Donald J., Jr.; Todd, Jacqueline

1992-01-01

Using a structured, experienced-based approach, Goddard Space Flight Center (GSFC) has assessed the generic functional requirements for a lunar mission control and data delivery (CDD) system. This analysis was based on lunar mission requirements outlined in GSFC-developed user traffic models. The CDD system will facilitate data transportation among user elements, element operations, and user teams by providing functions such as data management, fault isolation, fault correction, and link acquisition. The CDD system for the lunar missions must not only satisfy lunar requirements but also facilitate and provide early development of data system technologies for Mars. Reuse and evolution of existing data systems can help to maximize system reliability and minimize cost. This paper presents a set of existing and currently planned NASA data systems that provide the basic functionality. Reuse of such systems can have an impact on mission design and significantly reduce CDD and other system development costs.

The Generic Resolution Advisor and Conflict Evaluator (GRACE) for Unmanned Aircraft Detect-And-Avoid Systems

NASA Technical Reports Server (NTRS)

Abramson, Michael; Refai, Mohamad; Santiago, Confesor

2017-01-01

The paper describes the Generic Resolution Advisor and Conflict Evaluator (GRACE), a novel alerting and guidance algorithm that combines flexibility, robustness, and computational efficiency. GRACE is generic since it was designed without any assumptions regarding temporal or spatial scales, aircraft performance, or its sensor and communication systems. Therefore, GRACE was adopted as a core component of the Java Architecture for Detect-And-Avoid (DAA) Extensibility and Modeling, developed by NASA as a research and modeling tool for Unmanned Aerial Systems Integration in the National Airspace System (NAS). GRACE has been used in a number of real-time and fast-time experiments supporting evolving requirements of DAA research, including parametric studies, NAS-wide simulations, human-in-the-loop experiments, and live flight tests.

[Limiting a Medline/PubMed query to the "best" articles using the JCR relative impact factor].

PubMed

Avillach, P; Kerdelhué, G; Devos, P; Maisonneuve, H; Darmoni, S J

2014-12-01

Medline/PubMed is the most frequently used medical bibliographic research database. The aim of this study was to propose a new generic method to limit any Medline/PubMed query based on the relative impact factor and the A & B categories of the SIGAPS score. The entire PubMed corpus was used for the feasibility study, then ten frequent diseases in terms of PubMed indexing and the citations of four Nobel prize winners. The relative impact factor (RIF) was calculated by medical specialty defined in Journal Citation Reports. The two queries, which included all the journals in category A (or A OR B), were added to any Medline/PubMed query as a central point of the feasibility study. Limitation using the SIGAPS category A was larger than the when using the Core Clinical Journals (CCJ): 15.65% of PubMed corpus vs 8.64% for CCJ. The response time of this limit applied to the entire PubMed corpus was less than two seconds. For five diseases out of ten, limiting the citations with the RIF was more effective than with the CCJ. For the four Nobel prize winners, limiting the citations with the RIF was more effective than the CCJ. The feasibility study to apply a new filter based on the relative impact factor on any Medline/PubMed query was positive. Copyright © 2014 Elsevier Masson SAS. All rights reserved.

Surface Pressure Dependencies in the GEOS-Chem-Adjoint System and the Impact of the GEOS-5 Surface Pressure on CO2 Model Forecast

NASA Technical Reports Server (NTRS)

Lee, Meemong; Weidner, Richard

2016-01-01

In the GEOS-Chem Adjoint (GCA) system, the total (wet) surface pressure of the GEOS meteorology is employed as dry surface pressure, ignoring the presence of water vapor. The Jet Propulsion Laboratory (JPL) Carbon Monitoring System (CMS) research team has been evaluating the impact of the above discrepancy on the CO2 model forecast and the CO2 flux inversion. The JPL CMS research utilizes a multi-mission assimilation framework developed by the Multi-Mission Observation Operator (M2O2) research team at JPL extending the GCA system. The GCA-M2O2 framework facilitates mission-generic 3D and 4D-variational assimilations streamlining the interfaces to the satellite data products and prior emission inventories. The GCA-M2O2 framework currently integrates the GCA system version 35h and provides a dry surface pressure setup to allow the CO2 model forecast to be performed with the GEOS-5 surface pressure directly or after converting it to dry surface pressure.

Surface Pressure Dependencies in the Geos-Chem-Adjoint System and the Impact of the GEOS-5 Surface Pressure on CO2 Model Forecast

NASA Technical Reports Server (NTRS)

Lee, Meemong; Weidner, Richard

2016-01-01

In the GEOS-Chem Adjoint (GCA) system, the total (wet) surface pressure of the GEOS meteorology is employed as dry surface pressure, ignoring the presence of water vapor. The Jet Propulsion Laboratory (JPL) Carbon Monitoring System (CMS) research team has been evaluating the impact of the above discrepancy on the CO2 model forecast and the CO2 flux inversion. The JPL CMS research utilizes a multi-mission assimilation framework developed by the Multi-Mission Observation Operator (M2O2) research team at JPL extending the GCA system. The GCA-M2O2 framework facilitates mission-generic 3D and 4D-variational assimilations streamlining the interfaces to the satellite data products and prior emission inventories. The GCA-M2O2 framework currently integrates the GCA system version 35h and provides a dry surface pressure setup to allow the CO2 model forecast to be performed with the GEOS-5 surface pressure directly or after converting it to dry surface pressure.

Enhanced early warning system impact on nursing practice: A phenomenological study.

PubMed

Burns, Kathleen A; Reber, Tracey; Theodore, Karen; Welch, Brenda; Roy, Debra; Siedlecki, Sandra L

2018-05-01

To determine how an enhanced early warning system has an impact on nursing practice. Early warning systems score physiologic measures and alert nurses to subtle changes in patient condition. Critics of early warning systems have expressed concern that nurses would rely on a score rather than assessment skills and critical thinking to determine the need for intervention. Enhancing early warning systems with innovative technology is still in its infancy, so the impact of an enhanced early warning system on nursing behaviours or practice has not yet been studied. Phenomenological design. Scripted, semistructured interviews were conducted in September 2015 with 25 medical/surgical nurses who used the enhanced early warning system. Data were analysed using thematic analysis techniques (coding and bracketing). Emerging themes were examined for relationships and a model describing the enhanced early warning system experience was developed. Nurses identified awareness leading to investigation and ease of prioritization as the enhanced early warning system's most important impact on their nursing practice. There was also an impact on organizational culture, with nurses reporting improved communication, increased collaboration, increased accountability and proactive responses to early changes in patient condition. Rather than hinder critical thinking, as many early warning systems' critics claim, nurses in this study found that the enhanced early warning system increased their awareness of changes in a patient's condition, resulting in earlier response and reassessment times. It also had an impact on the organization by improving communication and collaboration and supporting a culture of proactive rather than reactive response to early signs of deterioration. © 2017 John Wiley & Sons Ltd.

Impacts of supersymmetric higher derivative terms on inflation models in supergravity

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

Aoki, Shuntaro; Yamada, Yusuke, E-mail: shun-soccer@akane.waseda.jp, E-mail: yuusuke-yamada@asagi.waseda.jp

2015-07-01

We show the effects of supersymmetric higher derivative terms on inflation models in supergravity. The results show that such terms generically modify the effective kinetic coefficient of the inflaton during inflation if the cut off scale of the higher derivative operators is sufficiently small. In such a case, the η-problem in supergravity does not occur, and we find that the effective potential of the inflaton generically becomes a power type potential with a power smaller than two.

The Impact of Supplemental Education Services Program on Middle School At-Risk Learners' Math and Reading Scores

ERIC Educational Resources Information Center

Maxwell, June B.

2010-01-01

In the state of Georgia, local school systems are under pressure to increase at-risk middle school students' state scores in reading and math. At the data site, the local school system implemented a supplemental education service (SES) program for at-risk students in order to pass the Georgia Criterion Referenced Competency Test (CRCT) in reading…

System Dynamics Approach for Critical Infrastructure and Decision Support. A Model for a Potable Water System.

NASA Astrophysics Data System (ADS)

Pasqualini, D.; Witkowski, M.

2005-12-01

The Critical Infrastructure Protection / Decision Support System (CIP/DSS) project, supported by the Science and Technology Office, has been developing a risk-informed Decision Support System that provides insights for making critical infrastructure protection decisions. The system considers seventeen different Department of Homeland Security defined Critical Infrastructures (potable water system, telecommunications, public health, economics, etc.) and their primary interdependencies. These infrastructures have been modeling in one model called CIP/DSS Metropolitan Model. The modeling approach used is a system dynamics modeling approach. System dynamics modeling combines control theory and the nonlinear dynamics theory, which is defined by a set of coupled differential equations, which seeks to explain how the structure of a given system determines its behavior. In this poster we present a system dynamics model for one of the seventeen critical infrastructures, a generic metropolitan potable water system (MPWS). Three are the goals: 1) to gain a better understanding of the MPWS infrastructure; 2) to identify improvements that would help protect MPWS; and 3) to understand the consequences, interdependencies, and impacts, when perturbations occur to the system. The model represents raw water sources, the metropolitan water treatment process, storage of treated water, damage and repair to the MPWS, distribution of water, and end user demand, but does not explicitly represent the detailed network topology of an actual MPWS. The MPWS model is dependent upon inputs from the metropolitan population, energy, telecommunication, public health, and transportation models as well as the national water and transportation models. We present modeling results and sensitivity analysis indicating critical choke points, negative and positive feedback loops in the system. A general scenario is also analyzed where the potable water system responds to a generic disruption.

The impact of generic language about ability on children's achievement motivation.

PubMed

Cimpian, Andrei

2010-09-01

Nuances in how adults talk about ability may have important consequences for children's sustained involvement and success in an activity. In this study, I tested the hypothesis that children would be less motivated while performing a novel activity if they were told that boys or girls in general are good at this activity (generic language) than if they were told that a particular boy or girl is good at it (non-generic language). Generic language may be detrimental because it expresses normative societal expectations regarding performance. If these expectations are negative, they may cause children to worry about confirming them; if positive, they may cause worries about failing to meet them. Moreover, generic statements may be threatening because they imply that performance is the result of stable traits rather than effort. Ninety-seven 4- to 7-year-olds were asked to play a game in which they succeeded at first but then made a few mistakes. Since young children remain optimistic in achievement situations until the possibility of failure is made clear, I hypothesized that 4- and 5-year-olds would not be affected by the implications of generic language until after they made mistakes; 6- and 7-year-olds, however, may be susceptible earlier. As expected, the older children who heard that boys or girls are good at this game displayed lower motivation (e.g., more negative emotions, lower perceived competence) from the start, while they were still succeeding and receiving praise. Four- and 5-year-olds who heard these generic statements had a similar reaction, but only after they made mistakes. These findings demonstrate that exposure to generic language about ability can be an obstacle to children's motivation and, potentially, their success.

Creating New Economic Incentives for Repurposing Generic Drugs for Unsolved Diseases Using Social Finance.

PubMed

Bloom, Bruce E

2015-12-01

Repurposing research improves patient lives by taking drugs approved for one disease and clinically testing them to create a treatment for a different disease. Repurposing drugs that are generic, inexpensive, and widely available and that can be taken in their current dosage and formulation in the new indication provide a quick, affordable, and effective way to create "new" treatments. However, generic drug repurposing often provides no profit potential, and so there is no economic incentive for industry to pursue this, and philanthropy and government funds are often insufficient. One way to create new economic incentive for the repurposing of generic drugs is through social finance. This perspective describes how social finance can create a new economic incentive by using a social impact bond, or similar financial structure, to repay for-profit investors who fund the repurposing research from the proceeds of healthcare cost reductions generated when these affordable, effective, and widely available repurposed therapies improve healthcare outcomes.

High prevalence of body dysmorphic disorder symptoms in patients seeking rhinoplasty.

PubMed

Picavet, Valerie A; Prokopakis, Emmanuel P; Gabriëls, Lutgardis; Jorissen, Mark; Hellings, Peter W

2011-08-01

Nasal aesthetic deformities may be associated with significant body image dissatisfaction. The only diagnostic category in the current list of psychiatric disorders that directly addresses these concerns is body dysmorphic disorder. This large-scale study determined the prevalence of body dysmorphic disorder and its symptoms in patients seeking rhinoplasty and evaluated the clinical profile of these patients. Two hundred twenty-six patients were given questionnaires including demographic characteristics, visual analogue scales for nasal shape, the Yale-Brown Obsessive Compulsive Scale modified for body dysmorphic disorder to assess severity of symptoms, a generic quality-of-life questionnaire, and the Derriford Appearance Scale 59, to assess appearance-related disruption of everyday living. Independent observers scored the nasal shape. Thirty-three percent of patients showed at least moderate symptoms of body dysmorphic disorder. Aesthetic goals (p < 0.001), revision rhinoplasty (p = 0.003), and psychiatric history (p = 0.031) were associated with more severe symptoms. There was no correlation between the objective and subjective scoring of the nasal shape. Yale-Brown scale modified for body dysmorphic disorder scores correlated inversely with the subjective nasal scoring (n = 210, p < 0.001), without relation to the objective deformity of the nose. Body dysmorphic disorder symptoms significantly reduced the generic quality of life (n = 160, p < 0.001) and led to significant appearance-related disruption of everyday living (n = 161, p < 0.001). The prevalence of moderate to severe body dysmorphic disorder symptoms in an aesthetic rhinoplasty population is high. Patients undergoing revision rhinoplasty and with psychiatric history are particularly at risk. Body dysmorphic disorder symptoms significantly reduce the quality of life and cause significant appearance-related disruption of everyday living. Risk, III.

The meaning of (quality of) life in patients with eating disorders: a comparison of generic and disease-specific measures across diagnosis and outcome.

PubMed

Ackard, Diann M; Richter, Sara; Egan, Amber; Engel, Scott; Cronemeyer, Catherine L

2014-04-01

Compare general and disease-specific health-related quality of life (HRQoL) among female patients with an eating disorder (ED). Female patients (n = 221; 95.3% Caucasian; 94.0% never married) completed the Medical Outcome Short Form Health Survey (SF-36) and Eating Disorders Quality of Life (EDQoL) as part of a study of treatment outcomes. Multivariate regression models were used to compare HRQoL differences across initial ED diagnosis (85 AN-R, 19 AN-B/P, 27 BN, 90 EDNOS) and ED diagnostic classification at time of outcome assessment (140 no ED, 38 subthreshold ED, 43 full threshold ED). There were no significant differences across ED diagnosis at initial assessment on either of the SF-36 Component Summary scores. However, patients with AN-B/P scored poorer on the work/school EDQoL subscales than other ED diagnoses, and on the psychological EDQoL subscale compared to AN-R and EDNOS. At outcome assessment, comparisons across full threshold, subthreshold and no ED classification indicated that those with no ED reported better HRQoL than those with full threshold ED on the SF-36 Mental Components Summary and three of four EDQoL subscales. Furthermore, those with no ED reported better psychological HRQoL than those with subthreshold ED. Disease-specific HRQOL measures are important to use when comparing HRQoL in ED patients across treatment and outcome, and may have the sensitivity to detect meaningful differences by diagnosis more so than generic instruments. EDQoL scores from patients remitted from symptoms approach but do not reach scores for unaffected college females; thus, treatment should continue until quality of life is restored. Copyright © 2013 Wiley Periodicals, Inc.

UQTools: The Uncertainty Quantification Toolbox - Introduction and Tutorial

NASA Technical Reports Server (NTRS)

Kenny, Sean P.; Crespo, Luis G.; Giesy, Daniel P.

2012-01-01

UQTools is the short name for the Uncertainty Quantification Toolbox, a software package designed to efficiently quantify the impact of parametric uncertainty on engineering systems. UQTools is a MATLAB-based software package and was designed to be discipline independent, employing very generic representations of the system models and uncertainty. Specifically, UQTools accepts linear and nonlinear system models and permits arbitrary functional dependencies between the system s measures of interest and the probabilistic or non-probabilistic parametric uncertainty. One of the most significant features incorporated into UQTools is the theoretical development centered on homothetic deformations and their application to set bounding and approximating failure probabilities. Beyond the set bounding technique, UQTools provides a wide range of probabilistic and uncertainty-based tools to solve key problems in science and engineering.

Computer-based diagnostic decisionmaking.

PubMed

Miller, R A

1987-12-01

The three decisionmaking aids described by the authors attack the generic problem of "see no evil, hear no evil, speak no evil"--improving the detection, diagnosis, and therapy of psychiatric disorders in the primary care setting. The three systems represent interventions at different steps in the process of providing appropriate care to psychiatric patients. The DSPW system of Robins and Marcus offers the potential of increasing the recognition of psychiatric disease in the physician's office. Politser's IDS program is representative of the sort of sophisticated microcomputer-based decisionmaking support tools that will become available to physicians in the not-too-distant future. Erdman's study of the impact of explanation capabilities on the acceptability of therapy recommending systems points out the need for careful scientific evaluations of features added to diagnostic and therapeutic systems.

The Impact of Rater Variability on Relationships among Different Effect-Size Indices for Inter-Rater Agreement between Human and Automated Essay Scoring

ERIC Educational Resources Information Center

Yun, Jiyeo

2017-01-01

Since researchers investigated automatic scoring systems in writing assessments, they have dealt with relationships between human and machine scoring, and then have suggested evaluation criteria for inter-rater agreement. The main purpose of my study is to investigate the magnitudes of and relationships among indices for inter-rater agreement used…

External validity of a generic safety climate scale for lone workers across different industries and companies.

PubMed

Lee, Jin; Huang, Yueng-hsiang; Robertson, Michelle M; Murphy, Lauren A; Garabet, Angela; Chang, Wen-Ruey

2014-02-01

The goal of this study was to examine the external validity of a 12-item generic safety climate scale for lone workers in order to evaluate the appropriateness of generalized use of the scale in the measurement of safety climate across various lone work settings. External validity evidence was established by investigating the measurement equivalence (ME) across different industries and companies. Confirmatory factor analysis (CFA)-based and item response theory (IRT)-based perspectives were adopted to examine the ME of the generic safety climate scale for lone workers across 11 companies from the trucking, electrical utility, and cable television industries. Fairly strong evidence of ME was observed for both organization- and group-level generic safety climate sub-scales. Although significant invariance was observed in the item intercepts across the different lone work settings, absolute model fit indices remained satisfactory in the most robust step of CFA-based ME testing. IRT-based ME testing identified only one differentially functioning item from the organization-level generic safety climate sub-scale, but its impact was minimal and strong ME was supported. The generic safety climate scale for lone workers reported good external validity and supported the presence of a common feature of safety climate among lone workers. The scale can be used as an effective safety evaluation tool in various lone work situations. Copyright © 2013 Elsevier Ltd. All rights reserved.

Generic substitution of antiepileptic drugs.

PubMed

Sander, Josemir W; Ryvlin, Philippe; Stefan, Hermann; Booth, Daniel R; Bauer, Jürgen

2010-12-01

Substitution of antiepileptic drugs with generic formulations may affect individual people, as well as healthcare systems. Analyses of large medical claims databases suggest that generic substitution of antiepileptic drugs is associated with increased morbidity and greater use of healthcare resources. While a single brand-to-generic switch may be associated with a slight increase in overall medical costs, multiple switches may be associated with higher costs, perhaps because different generic agents are not required to be bioequivalent to each other. Generic substitution also affects the individual: along with the possible increased risk of seizures or adverse events, inconsistency of supply may make the medication appear unfamiliar, thus discouraging adherence. Importantly, substitution is often carried out at the dispensing level, without the knowledge or consent of physicians and affected individuals. Therefore, regulatory and professional bodies advocate that substitution should not be carried out without specific counseling of the individual by healthcare professionals on the details and implications of the change.

78 FR 19261 - Environmental Impacts Statements; Notice of Availability

Federal Register 2010, 2011, 2012, 2013, 2014

2013-03-29

... No. 20130073, Draft Supplement, NRC, WY Ross In-Situ Leach Recovery (ISR) Project, Supplement to the Generic Environmental Impact Statement for In-Situ Leach Uranium Milling Facilities, Comment Period Ends... project. EIS No. 20130075, Draft Supplement, NMFS, AK, Effects of Oil and Gas Activities in the Arctic...

Generic Environmental Impact Statement. Air Force Low Altitude Flying Operations

DTIC Science & Technology

1990-01-01

evaluating impacts of proposed new or modified airspace allocations for low altitude operations in Vol MI E/AP Guide. 1.62 M d 1.6.21 Devopment of data As...Seattle, Washington Fred Bonner, Outdoor Editor, Capitol Radio Networks Doug Bowie, United States Forest Service Michael Bronoski, United States

The Impact of British Airways Wind Observations on the Goddard Earth Observing System Analyses and Forecasts

NASA Technical Reports Server (NTRS)

Rukhovets, Leonid; Sienkiewicz, M.; Tenenbaum, J.; Kondratyeva, Y.; Owens, T.; Oztunali, M.; Atlas, Robert (Technical Monitor)

2001-01-01

British Airways flight data recorders can provide valuable meteorological information, but they are not available in real-time on the Global Telecommunication System. Information from the flight recorders was used in the Global Aircraft Data Set (GADS) experiment as independent observations to estimate errors in wind analyses produced by major operational centers. The GADS impact on the Goddard Earth Observing System Data Assimilation System (GEOS DAS) analyses was investigated using GEOS-1 DAS version. Recently, a new Data Assimilation System (fvDAS) has been developed at the Data Assimilation Office, NASA Goddard. Using fvDAS , the, GADS impact on analyses and forecasts was investigated. It was shown the GADS data intensify wind speed analyses of jet streams for some cases. Five-day forecast anomaly correlations and root mean squares were calculated for 300, 500 hPa and SLP for six different areas: Northern and Southern Hemispheres, North America, Europe, Asia, USA These scores were obtained as averages over 21 forecasts from January 1998. Comparisons with scores for control experiments without GADS showed a positive impact of the GADS data on forecasts beyond 2-3 days for all levels at the most areas.