The International Collaboration for Autism Registry Epidemiology (iCARE): multinational registry-based investigations of autism risk factors and trends.

PubMed

Schendel, Diana E; Bresnahan, Michaeline; Carter, Kim W; Francis, Richard W; Gissler, Mika; Grønborg, Therese K; Gross, Raz; Gunnes, Nina; Hornig, Mady; Hultman, Christina M; Langridge, Amanda; Lauritsen, Marlene B; Leonard, Helen; Parner, Erik T; Reichenberg, Abraham; Sandin, Sven; Sourander, Andre; Stoltenberg, Camilla; Suominen, Auli; Surén, Pål; Susser, Ezra

2013-11-01

The International Collaboration for Autism Registry Epidemiology (iCARE) is the first multinational research consortium (Australia, Denmark, Finland, Israel, Norway, Sweden, USA) to promote research in autism geographical and temporal heterogeneity, phenotype, family and life course patterns, and etiology. iCARE devised solutions to challenges in multinational collaboration concerning data access security, confidentiality and management. Data are obtained by integrating existing national or state-wide, population-based, individual-level data systems and undergo rigorous harmonization and quality control processes. Analyses are performed using database federation via a computational infrastructure with a secure, web-based, interface. iCARE provides a unique, unprecedented resource in autism research that will significantly enhance the ability to detect environmental and genetic contributions to the causes and life course of autism.

Multiple Learning Tracks: For Training Multinational Managers

ERIC Educational Resources Information Center

Harvey, Michael G.; Kerin, Roger A.

1977-01-01

The problem of identifying and training college students to be effective multinational marketing managers is investigated in three parts: (1) Identification of multinational manager attributes, (2) selection of multinational managers, and (3) multiple "track" training programs. (TA)

The effects of AST-120 on chronic kidney disease progression in the United States of America: a post hoc subgroup analysis of randomized controlled trials.

PubMed

Schulman, Gerald; Berl, Tomas; Beck, Gerald J; Remuzzi, Giuseppe; Ritz, Eberhard; Shimizu, Miho; Shobu, Yuko; Kikuchi, Mami

2016-09-30

The orally administered spherical carbon adsorbent AST-120 is used on-label in Asian countries to slow renal disease progression in patients with progressive chronic kidney disease (CKD). Recently, two multinational, randomized, double-blind, placebo-controlled, phase 3 trials (Evaluating Prevention of Progression in Chronic Kidney Disease [EPPIC] trials) examined AST-120's efficacy in slowing CKD progression. This study assessed the efficacy of AST-120 in the subgroup of patients from the United States of America (USA) in the EPPIC trials. In the EPPIC trials, 2035 patients with moderate to severe CKD were studied, of which 583 were from the USA. The patients were randomly assigned to two groups of equal size that were treated with AST-120 or placebo (9 g/day). The primary end point was a composite of dialysis initiation, kidney transplantation, or serum creatinine doubling. The Kaplan-Meier curve for the time to achieve the primary end point in the placebo-treated patients from the USA was similar to that projected before the study. The per protocol subgroup analysis of the population from the USA which included patients with compliance rates of ≥67 % revealed a significant difference between the treatment groups in the time to achieve the primary end point (Hazard Ratio, 0.74; 95 % Confidence Interval, 0.56-0.97). This post hoc subgroup analysis of EPPIC study data suggests that treatment with AST-120 might delay the time to primary end point in CKD patients from the USA. A further randomized controlled trial in progressive CKD patients in the USA is necessary to confirm the beneficial effect of adding AST-120 to standard therapy regimens. ClinicalTrials.gov NCT00500682 ; NCT00501046 .

The safety, tolerability, and efficacy of once-daily memantine (28 mg): a multinational, randomized, double-blind, placebo-controlled trial in patients with moderate-to-severe Alzheimer's disease taking cholinesterase inhibitors.

PubMed

Grossberg, George T; Manes, Facundo; Allegri, Ricardo F; Gutiérrez-Robledo, Luis Miguel; Gloger, Sergio; Xie, Lei; Jia, X Daniel; Pejović, Vojislav; Miller, Michael L; Perhach, James L; Graham, Stephen M

2013-06-01

Immediate-release memantine (10 mg, twice daily) is approved in the USA for moderate-to-severe Alzheimer's disease (AD). This study evaluated the efficacy, safety, and tolerability of a higher-dose, once-daily, extended-release formulation in patients with moderate-to-severe AD concurrently taking cholinesterase inhibitors. In this 24-week, double-blind, multinational study (NCT00322153), outpatients with AD (Mini-Mental State Examination scores of 3-14) were randomized to receive once-daily, 28-mg, extended-release memantine or placebo. Co-primary efficacy parameters were the baseline-to-endpoint score change on the Severe Impairment Battery (SIB) and the endpoint score on the Clinician's Interview-Based Impression of Change Plus Caregiver Input (CIBIC-Plus). The secondary efficacy parameter was the baseline-to-endpoint score change on the 19-item Alzheimer's Disease Cooperative Study-Activities of Daily Living (ADCS-ADL19); additional parameters included the baseline-to-endpoint score changes on the Neuropsychiatric Inventory (NPI) and verbal fluency test. Data were analyzed using a two-way analysis of covariance model, except for CIBIC-Plus (Cochran-Mantel-Haenszel test). Safety and tolerability were assessed through adverse events and physical and laboratory examinations. A total of 677 patients were randomized to receive extended-release memantine (n = 342) or placebo (n = 335); completion rates were 79.8 and 81.2 %, respectively. At endpoint (week 24, last observation carried forward), memantine-treated patients significantly outperformed placebo-treated patients on the SIB (least squares mean difference [95 % CI] 2.6 [1.0, 4.2]; p = 0.001), CIBIC-Plus (p = 0.008), NPI (p = 0.005), and verbal fluency test (p = 0.004); the effect did not achieve significance on ADCS-ADL19 (p = 0.177). Adverse events with a frequency of ≥5.0 % that were more prevalent in the memantine group were headache (5.6 vs. 5.1 %) and diarrhea (5.0 vs. 3.9 %). Extended-release memantine was efficacious, safe, and well tolerated in this population.

Multinational corporate penetration, industrialism, region, and social security expenditures: a cross-national analysis.

PubMed

Clark, R; Filinson, R

1991-01-01

This study examines the determinants of spending on social security programs. We draw predictions from industrialism and dependency theories for the explanation of social security programs. The explanations are tested with data on seventy-five nations, representative of core, semipheripheral and peripheral nations. Industrialization variables such as the percentage of older adults and economic productivity have strong effects in models involving all nations, as does multinational corporate (MNC) penetration in extraction, particularly when region is controlled; such penetration is negatively associated with spending on social security. We then look at industrialism and dependency effects for peripheral and non-core nations alone. The effects of all industrialization variables, except economic productivity, appear insignificant for peripheral nations, while the effects of region and multinational corporate penetration in extractive and agricultural industries appears significant. Models involving all non-core nations (peripheral and semi-peripheral) look more like models for all nations than for peripheral nations alone.

Multinational outbreak of Salmonella Enteritidis infection during an international youth ice hockey competition in Riga, Latvia, preliminary report, March and April 2015.

PubMed

Pesola, A K; Parn, T; Huusko, S; Perevosčikovs, J; Ollgren, J; Salmenlinna, S; Lienemann, T; Gossner, C; Danielsson, N; Rimhanen-Finne, R

2015-05-21

A multinational outbreak of salmonellosis linked to the Riga Cup 2015 junior ice-hockey competition was detected by the Finnish health authorities in mid-April and immediately notified at the European Union level. This prompted an international outbreak investigation supported by the European Centre for Disease Prevention and Control. As of 8 May 2015, seven countries have reported 214 confirmed and suspected cases, among which 122 from Finland. The search for the source of the outbreak is ongoing.

Air Force Journal of Logistics. Volume 24, Number 3, Fall 2000

DTIC Science & Technology

2000-01-01

senior officers environment. 49 should hold key positions. The joint practice of assigning an In The Argument Culture, Deborah Tannen suggests Americans...Action Division, Directorate of Plans and Integration, Deputy 44. Deborah Tannen , The Argument Culture, New York: Random House, Chief of Staff for...staff.4 " Proportionate representation would Americans must find the opposing view. Tannen says Americans * establish multinationalism as the norm and

Cultural Penetration in Latin America through Multinational Advertising Agencies.

ERIC Educational Resources Information Center

Del Toro, Wanda

Few studies have addressed the issue of cultural penetration of Latin American countries by multinational corporations (MNCs) and multinational advertising agencies (MAAs). Whether they are considered multinational or transnational, MAAs have expanded as a form of international communication in the global market, forming the backbone of MNCs.…

A multinational clinical approach to assessing the effectiveness of catheter-based ultrasound renal denervation: The RADIANCE-HTN and REQUIRE clinical study designs.

PubMed

Mauri, Laura; Kario, Kazuomi; Basile, Jan; Daemen, Joost; Davies, Justin; Kirtane, Ajay J; Mahfoud, Felix; Schmieder, Roland E; Weber, Michael; Nanto, Shinsuke; Azizi, Michel

2018-01-01

Catheter-based renal denervation is a new approach to treat hypertension via modulation of the renal sympathetic nerves. Although nonrandomized and small, open-label randomized studies resulted in significant reductions in office blood pressure 6months after renal denervation with monopolar radiofrequency catheters, the first prospective, randomized, sham-controlled study (Symplicity HTN-3) failed to meet its blood pressure efficacy end point. New clinical trials with new catheters have since been designed to address the limitations of earlier studies. Accordingly, the RADIANCE-HTN and REQUIRE studies are multicenter, blinded, randomized, sham-controlled trials designed to assess the blood pressure-lowering efficacy of the ultrasound-based renal denervation system (Paradise) in patients with established hypertension either on or off antihypertensive medications, is designed to evaluate patients in 2 cohorts-SOLO and TRIO, in the United States and Europe. The SOLO cohort includes patients with essential hypertension, at low cardiovascular risk, and either controlled on 1 to 2 antihypertensive medications or uncontrolled on 0 to 2 antihypertensive medications. Patients undergo a 4-week medication washout period before randomization to renal denervation (treatment) or renal angiogram (sham). The TRIO cohort includes patients with hypertension resistant to at least 3 antihypertensive drugs including a diuretic. Patients will be stabilized on a single-pill, triple-antihypertensive-drug combination for 4weeks before randomization to treatment or sham. Reduction in daytime ambulatory systolic blood pressure (primary end point) will be assessed at 2months in both cohorts. A predefined medication escalation protocol, as needed for blood pressure control, is implemented between 2 and 6months in both cohorts by a study staff member blinded to the randomization process. At 6months, daytime ambulatory blood pressure and antihypertensive treatment score will be assessed. REQUIRE is designed to evaluate patients with resistant hypertension on standard of care medication in Japan and Korea. Reduction in 24-hour ambulatory systolic blood pressure will be assessed at 3months (primary end point). Both studies are enrolling patients, and their results are expected in 2018. Copyright © 2017 Elsevier Inc. All rights reserved.

REVIVE Trial: Retrograde Delivery of Autologous Bone Marrow in Patients With Heart Failure.

PubMed

Patel, Amit N; Mittal, Sanjay; Turan, Goekmen; Winters, Amalia A; Henry, Timothy D; Ince, Hueseyin; Trehan, Naresh

2015-09-01

Cell therapy is an evolving option for patients with end-stage heart failure and ongoing symptoms despite optimal medical therapy. Our goal was to evaluate retrograde bone marrow cell delivery in patients with either ischemic heart failure (IHF) or nonischemic heart failure (NIHF). This was a prospective randomized, multicenter, open-label study of the safety and feasibility of bone marrow aspirate concentrate (BMAC) infused retrograde into the coronary sinus. Sixty patients were stratified by IHF and NIHF and randomized to receive either BMAC infusion or control (standard heart failure care) in a 4:1 ratio. Accordingly, 24 subjects were randomized to the ischemic BMAC group and 6 to the ischemic control group. Similarly, 24 subjects were randomized to the nonischemic BMAC group and 6 to the nonischemic control group. All 60 patients were successfully enrolled in the study. The treatment groups received BMAC infusion without complications. The left ventricular ejection fraction in the patients receiving BMAC demonstrated significant improvement compared with baseline, from 25.1% at screening to 31.1% at 12 months (p=.007) in the NIHF group and from 26.3% to 31.1% in the IHF group (p=.035). The end-systolic diameter decreased significantly in the nonischemic BMAC group from 55.6 to 50.9 mm (p=.020). Retrograde BMAC delivery is safe. All patients receiving BMAC experienced improvements in left ventricular ejection fraction, but only those with NIHF showed improvements in left ventricular end-systolic diameter and B-type natriuretic peptide. These results provide the basis for a larger clinical trial in HF patients. This work is the first prospective randomized clinical trial using high-dose cell therapy delivered via a retrograde coronary sinus infusion in patients with heart failure. This was a multinational, multicenter study, and it is novel, translatable, and scalable. On the basis of this trial and the safety of retrograde coronary sinus infusion, there are three other trials under way using this route of delivery. ©AlphaMed Press.

Marketing Norm Perception Among Medical Representatives in Indian Pharmaceutical Industry

PubMed Central

Nagashekhara, Molugulu; Agil, Syed Omar Syed; Ramasamy, Ravindran

2012-01-01

Study of marketing norm perception among medical representatives is an under-portrayed component that deserves further perusal in the pharmaceutical industry. The purpose of this study is to find out the perception of marketing norms among medical representatives. The research design is quantitative and cross sectional study with medical representatives as unit of analysis. Data is collected from medical representatives (n=300) using a simple random and cluster sampling using a structured questionnaire. Results indicate that there is no difference in the perception of marketing norms among male and female medical representatives. But there is a difference in opinion among domestic and multinational company’s medical representatives. Educational back ground of medical representatives also shows the difference in opinion among medical representatives. Degree holders and multinational company medical representatives have high perception of marketing norms compare to their counterparts. The researchers strongly believe that mandatory training on marketing norms is beneficial in decision making process during the dilemmas in the sales field. PMID:24826035

CONCEPTT: Continuous Glucose Monitoring in Women with Type 1 Diabetes in Pregnancy Trial: A multi-center, multi-national, randomized controlled trial - Study protocol.

PubMed

Feig, Denice S; Asztalos, Elizabeth; Corcoy, Rosa; De Leiva, Alberto; Donovan, Lois; Hod, Moshe; Jovanovic, Lois; Keely, Erin; Kollman, Craig; McManus, Ruth; Murphy, Kellie; Ruedy, Katrina; Sanchez, J Johanna; Tomlinson, George; Murphy, Helen R

2016-07-18

Women with type 1 diabetes strive for optimal glycemic control before and during pregnancy to avoid adverse obstetric and perinatal outcomes. For most women, optimal glycemic control is challenging to achieve and maintain. The aim of this study is to determine whether the use of real-time continuous glucose monitoring (RT-CGM) will improve glycemic control in women with type 1 diabetes who are pregnant or planning pregnancy. A multi-center, open label, randomized, controlled trial of women with type 1 diabetes who are either planning pregnancy with an HbA1c of 7.0 % to ≤10.0 % (53 to ≤ 86 mmol/mol) or are in early pregnancy (<13 weeks 6 days) with an HbA1c of 6.5 % to ≤10.0 % (48 to ≤ 86 mmol/mol). Participants will be randomized to either RT-CGM alongside conventional intermittent home glucose monitoring (HGM), or HGM alone. Eligible women will wear a CGM which does not display the glucose result for 6 days during the run-in phase. To be eligible for randomization, a minimum of 4 HGM measurements per day and a minimum of 96 hours total with 24 hours overnight (11 pm-7 am) of CGM glucose values are required. Those meeting these criteria are randomized to RT- CGM or HGM. A total of 324 women will be recruited (110 planning pregnancy, 214 pregnant). This takes into account 15 and 20 % attrition rates for the planning pregnancy and pregnant cohorts and will detect a clinically relevant 0.5 % difference between groups at 90 % power with 5 % significance. Randomization will stratify for type of insulin treatment (pump or multiple daily injections) and baseline HbA1c. Analyses will be performed according to intention to treat. The primary outcome is the change in glycemic control as measured by HbA1c from baseline to 24 weeks or conception in women planning pregnancy, and from baseline to 34 weeks gestation during pregnancy. Secondary outcomes include maternal hypoglycemia, CGM time in, above and below target (3.5-7.8 mmol/l), glucose variability measures, maternal and neonatal outcomes. This will be the first international multicenter randomized controlled trial to evaluate the impact of RT- CGM before and during pregnancy in women with type 1 diabetes. ClinicalTrials.gov Identifier: NCT01788527 Registration Date: December 19, 2012.

Multinational corporations, nation-states and ocean resource management: the impact of the world's 200-mile economic zone on multinational and national development

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

Gopalakrishnan, C.

1979-07-01

The extension of coastal state jurisdiction to 200-nautical miles - a fact of international law about to receive juridical status - would lead to a unique situation in the ownership of ocean resources, viz. 15 coastal states would receive among them approximately 42% of the world's 200-mile economic zone area. At least 8 of these countries are less-developed coastal states (LDCS) which lack the key factors, capital, technology, and managerial skill, necessary to tap these resources. As a result, the reliance of the LDCS on marine multinational corporations will markedly increase since a significant part of marine technology exists inmore » the private sector. Concurrently, a dramatic rise in the control of coastal states over MNCs engaged in ocean resource development will occur. Thus, under the new regime of ocean resource management, the relationship between MNCs and nation-states is likely to be one of constructive partnership in development, rather than one of conflict and discord.« less

Cost-effectiveness analysis using data from multinational trials: The use of bivariate hierarchical modelling

PubMed Central

Manca, Andrea; Lambert, Paul C; Sculpher, Mark; Rice, Nigel

2008-01-01

Healthcare cost-effectiveness analysis (CEA) often uses individual patient data (IPD) from multinational randomised controlled trials. Although designed to account for between-patient sampling variability in the clinical and economic data, standard analytical approaches to CEA ignore the presence of between-location variability in the study results. This is a restrictive limitation given that countries often differ in factors that could affect the results of CEAs, such as the availability of healthcare resources, their unit costs, clinical practice, and patient case-mix. We advocate the use of Bayesian bivariate hierarchical modelling to analyse multinational cost-effectiveness data. This analytical framework explicitly recognises that patient-level costs and outcomes are nested within countries. Using real life data, we illustrate how the proposed methods can be applied to obtain (a) more appropriate estimates of overall cost-effectiveness and associated measure of sampling uncertainty compared to standard CEA; and (b) country-specific cost-effectiveness estimates which can be used to assess the between-location variability of the study results, while controlling for differences in country-specific and patient-specific characteristics. It is demonstrated that results from standard CEA using IPD from multinational trials display a large degree of variability across the 17 countries included in the analysis, producing potentially misleading results. In contrast, ‘shrinkage estimates’ obtained from the modelling approach proposed here facilitate the appropriate quantification of country-specific cost-effectiveness estimates, while weighting the results based on the level of information available within each country. We suggest that the methods presented here represent a general framework for the analysis of economic data collected from different locations. PMID:17641141

Sharing the Burden: How Effective is a Multinational Force in the Contemporary Operational Environment

DTIC Science & Technology

2007-06-01

multinational setting justifies a reassessment of the benefits and costs of multinational operations and that the solution may lie in a “modular...Nonetheless, Brown identifies benefits from multinational commitments, relevant to this study: legitimacy, burden sharing and access to the battlefield and...require more robust tools and would benefit if supplemented by alliance and cooperative partnerships. Nations “are increasingly disinclined to

Multinational Activities of Major U.S. Automotive Producers : Volume 1. Summary.

DOT National Transportation Integrated Search

1978-09-01

The multinational activities of General Motors, Ford, Chrysler, and American Motors are documented and analyzed. The study contains a compilation of data related to multinational operations; specifically it addresses research, development, engineerin...

Implementation of graphic health warning labels on tobacco products in India: the interplay between the cigarette and the bidi industries

PubMed Central

Sankaran, Sujatha; Hiilamo, Heikki; Glantz, Stanton A

2014-01-01

Objectives To understand the competition between and among tobacco companies and health groups that led to graphical health warning labels (GHWL) on all tobacco products in India. Methods Analysis of internal tobacco industry documents in the Legacy Tobacco Document Library, documents obtained through Indias Right to Information ‘ Act, and news reports. Results Implementation of GHWLs in India reflects a complex interplay between the government and the cigarette and bidi industries, who have shared as well as conflicting interests. Joint lobbying by national-level tobacco companies (that are foreign subsidiaries of multinationals) and local producers of other forms of tobacco blocked GHWLs for decades and delayed the implementation of effective GHWLs after they were mandated in 2007. Tobacco control activists used public interest lawsuits and the Right to Information Act to win government implementation of GHWLs on cigarette, bidi and smokeless tobacco packs in May 2009 and rotating GHWLs in December 2011. Conclusions GHWLs in India illustrate how the presence of bidis and cigarettes in the same market creates a complex regulatory environment. The government imposing tobacco control on multinational cigarette companies led to the enforcement of regulation on local forms of tobacco. As other developing countries with high rates of alternate forms of tobacco use establish and enforce GHWL laws, the tobacco control advocacy community can use pressure on the multinational cigarette industry as an indirect tool to force implementation of regulations on other forms of tobacco. PMID:24950697

Meta-Analysis of Cell-based CaRdiac stUdiEs (ACCRUE) in patients with acute myocardial infarction based on individual patient data.

PubMed

Gyöngyösi, Mariann; Wojakowski, Wojciech; Lemarchand, Patricia; Lunde, Ketil; Tendera, Michal; Bartunek, Jozef; Marban, Eduardo; Assmus, Birgit; Henry, Timothy D; Traverse, Jay H; Moyé, Lemuel A; Sürder, Daniel; Corti, Roberto; Huikuri, Heikki; Miettinen, Johanna; Wöhrle, Jochen; Obradovic, Slobodan; Roncalli, Jérome; Malliaras, Konstantinos; Pokushalov, Evgeny; Romanov, Alexander; Kastrup, Jens; Bergmann, Martin W; Atsma, Douwe E; Diederichsen, Axel; Edes, Istvan; Benedek, Imre; Benedek, Theodora; Pejkov, Hristo; Nyolczas, Noemi; Pavo, Noemi; Bergler-Klein, Jutta; Pavo, Imre J; Sylven, Christer; Berti, Sergio; Navarese, Eliano P; Maurer, Gerald

2015-04-10

The meta-Analysis of Cell-based CaRdiac study is the first prospectively declared collaborative multinational database, including individual data of patients with ischemic heart disease treated with cell therapy. We analyzed the safety and efficacy of intracoronary cell therapy after acute myocardial infarction (AMI), including individual patient data from 12 randomized trials (ASTAMI, Aalst, BOOST, BONAMI, CADUCEUS, FINCELL, REGENT, REPAIR-AMI, SCAMI, SWISS-AMI, TIME, LATE-TIME; n=1252). The primary end point was freedom from combined major adverse cardiac and cerebrovascular events (including all-cause death, AMI recurrance, stroke, and target vessel revascularization). The secondary end point was freedom from hard clinical end points (death, AMI recurrence, or stroke), assessed with random-effects meta-analyses and Cox regressions for interactions. Secondary efficacy end points included changes in end-diastolic volume, end-systolic volume, and ejection fraction, analyzed with random-effects meta-analyses and ANCOVA. We reported weighted mean differences between cell therapy and control groups. No effect of cell therapy on major adverse cardiac and cerebrovascular events (14.0% versus 16.3%; hazard ratio, 0.86; 95% confidence interval, 0.63-1.18) or death (1.4% versus 2.1%) or death/AMI recurrence/stroke (2.9% versus 4.7%) was identified in comparison with controls. No changes in ejection fraction (mean difference: 0.96%; 95% confidence interval, -0.2 to 2.1), end-diastolic volume, or systolic volume were observed compared with controls. These results were not influenced by anterior AMI location, reduced baseline ejection fraction, or the use of MRI for assessing left ventricular parameters. This meta-analysis of individual patient data from randomized trials in patients with recent AMI revealed that intracoronary cell therapy provided no benefit, in terms of clinical events or changes in left ventricular function. URL: http://www.clinicaltrials.gov. Unique identifier: NCT01098591. © 2015 American Heart Association, Inc.

The NordICC Study: Rationale and design of a randomized trial on colonoscopy screening for colorectal cancer

PubMed Central

F.Kaminski, Michal; Bretthauer, Michael; Zauber, Ann G.; Kuipers, Ernst J.; Adami, Hans-Olov; van Ballegooijen, Marjolein; Regula, Jaroslaw; van Leerdam, Monique; Stefansson, Tryggvi; Påhlman, Lars; Dekker, Evelien; Hernán, Miguel A.; Garborg, Kjetil; Hoff, Geir

2017-01-01

Background While colonoscopy screening is widely used in several European countries and the United States, no randomised trials exist to quantify its benefits. The Nordic-European Initiative on Colorectal Cancer (NordICC) is a multinational, randomized controlled trial aiming at investigating the effect of colonoscopy screening on CRC incidence and mortality. This paper describes the rationale and design of the NordICC trial. Material and methods Men and women age 55 to 64 years are drawn from the population registries in the participating countries and randomly assigned to either once-only colonoscopy screening with removal of all detected lesions, or no screening (standard of care in the trial regions). All individuals are followed for 15 years after inclusion using dedicated national registries. Results The primary endpoints of the trial are cumulative CRC-specific death and CRC incidence during 15 years of follow up. We hypothesize a 50% CRC mortality-reducing efficacy of the colonoscopy intervention and predict 50% compliance, yielding a 25% mortality reduction among those invited to screening. For 90% power and a two-sided alpha level of 0.05, using a 2:1 randomisation, 45,600 individuals will be randomised to control, and 22,800 individuals to the colonoscopy group. Interim analyses of the effect of colonoscopy on CRC incidence and mortality will be performed at 10 years follow-up. Conclusions The aim of the NordICC trial is to quantify the effectiveness of population-based colonoscopy screening. This will allow development of evidence-based guidelines for CRC screening in the general population. PMID:22723185

Recall bias in the assessment of exposure to mobile phones.

PubMed

Vrijheid, Martine; Armstrong, Bruce K; Bédard, Daniel; Brown, Julianne; Deltour, Isabelle; Iavarone, Ivano; Krewski, Daniel; Lagorio, Susanna; Moore, Stephen; Richardson, Lesley; Giles, Graham G; McBride, Mary; Parent, Marie-Elise; Siemiatycki, Jack; Cardis, Elisabeth

2009-05-01

Most studies of mobile phone use are case-control studies that rely on participants' reports of past phone use for their exposure assessment. Differential errors in recalled phone use are a major concern in such studies. INTERPHONE, a multinational case-control study of brain tumour risk and mobile phone use, included validation studies to quantify such errors and evaluate the potential for recall bias. Mobile phone records of 212 cases and 296 controls were collected from network operators in three INTERPHONE countries over an average of 2 years, and compared with mobile phone use reported at interview. The ratio of reported to recorded phone use was analysed as measure of agreement. Mean ratios were virtually the same for cases and controls: both underestimated number of calls by a factor of 0.81 and overestimated call duration by a factor of 1.4. For cases, but not controls, ratios increased with increasing time before the interview; however, these trends were based on few subjects with long-term data. Ratios increased by level of use. Random recall errors were large. In conclusion, there was little evidence for differential recall errors overall or in recent time periods. However, apparent overestimation by cases in more distant time periods could cause positive bias in estimates of disease risk associated with mobile phone use.

Generation of Combat Power by Insurgents: An Historical Analysis

DTIC Science & Technology

2013-06-13

the concept of operations. Transportation incorporates military, commercial, and multinational assets. Transportation includes motor , rail, air...and water modes. Transportation nodes include motor , rail, air, and water terminal operations. Transportation also includes movement control and

The Effects of Organization Design on Media Richness in Multinational Enterprises.

ERIC Educational Resources Information Center

Whitfield, J. Michael; And Others

1996-01-01

Examines effects of two organizational design parameters, divisionalization and centralization, on the media richness choices of Chief Executive Officers (CEOs) of multinational enterprises in obtaining information from foreign subsidiaries on strategic issues. Samples 86 US multinationals; finds formal divisional structure affects CEOs' use of…

Cancer control in India: a multinational approach involving the USA and the USSR.

PubMed Central

Sutnick, A I; Saunders, J F; Puchkov, Y I

1982-01-01

Based on a long-standing cooperation in medicine and public health between the United States and the Soviet Union, and on the potential contributions to be made by scientists from both of these countries, the World Health Organization invited an American-Soviet collaborative team to recommend a cancer control program for the Government of India. The consultants defined the importance of cancer of the cervix uteri and of the oral cavity, which comprise one-half of India's cancer cases, as the basis for a cancer control program. They recommended incorporation of cancer control functions into the organizational structure of the Ministry of Health as well as specific recommendations in education, prevention, and early detection, diagnosis, treatment, and epidemiologic studies. The mission underscores the value of multinational cooperation on health care problems that are faced in common by the United States, the Soviet Union, and other countries of the world. In addition it serves as a basis for international friendship and understanding in the context of mutually productive activities which may provide a benefit for all nations. PMID:7091462

Multinational Activities of Major U.S. Automotive Producers : Volume 3. Research, Development, and Engineering Abroad

DOT National Transportation Integrated Search

1978-09-01

This is Volume III of the report on the multinational activities of the four major U.S. automotive producers. The primary objective of Volume III is to evaluate the RD&E activities performed abroad by the U.S. automotive multinationals in order to de...

Consulting-Research Froblems with German and American Multinational Firms.

ERIC Educational Resources Information Center

Hildebrandt, Herbert W.

International researchers need to be aware of international problems and multinational managerial codes when they work with worldwide organizations. This paper develops the premise that consulting with German multinational companies is more complex than consulting with or researching for American firms. Discussion focuses on the following three…

More Than We Bargained For: The Impact of Consumer Culture in Southeast Asia.

ERIC Educational Resources Information Center

Frith, Katherine T.

Advertising by multinational corporations in Southeast Asia is generating a growing resistance to its perceived role in creating a "consumer culture" damaging to indigenous values systems. Critics of advertising in Southeast Asia argue that when multinational advertisers or their multinational advertising agencies move into this foreign…

The World Economy and Multinational Corporations: An Activity Program for Grades 9 through 12.

ERIC Educational Resources Information Center

Caterpillar Tractor Co., Peoria, IL.

This booklet for secondary students contains background information and activities about the multinational corporation (MNC). The major goal of the booklet is to impart an understanding of the economic concepts underlying the world economy and the activities of multinational business enterprises. The world economy, the exchange of goods and…

Evaluating the Investment Benefit of Multinational Enterprises' International Projects Based on Risk Adjustment: Evidence from China

ERIC Educational Resources Information Center

Chen, Chong

2016-01-01

This study examines the international risks faced by multinational enterprises to understand their impact on the evaluation of investment projects. Moreover, it establishes a 'three-dimensional' theoretical framework of risk identification to analyse the composition of international risk indicators of multinational enterprises based on the theory…

On the topological structure of multinationals network

NASA Astrophysics Data System (ADS)

Joyez, Charlie

2017-05-01

This paper uses a weighted network analysis to examine the structure of multinationals' implantation countries network. Based on French firm-level dataset of multinational enterprises (MNEs) the network analysis provides information on each country position in the network and in internationalization strategies of French MNEs through connectivity preferences among the nodes. The paper also details network-wide features and their recent evolution toward a more decentralized structure. While much has been said on international trade network, this paper shows that multinational firms' studies would also benefit from network analysis, notably by investigating the sensitivity of the network construction to firm heterogeneity.

Globalization and the Inward Flow of Immigrants: Issues Associated with the Inpatriation of Global Managers

ERIC Educational Resources Information Center

Harvey, Michael; Kiessling, Tim; Moeller, Miriam

2011-01-01

Assembling a diverse global workforce is becoming a critical dimension in gaining successful global performance. In the past, staffing has focused on control of the multinational organization as the primary goal when staffing overseas positions. As organizations globalize their operations, the goal of staffing is shifting from control to…

A three-country randomized controlled trial of a psychosocial intervention for caregivers combined with pharmacological treatment for patients with Alzheimer disease: effects on caregiver depression.

PubMed

Mittelman, Mary Sherman; Brodaty, Henry; Wallen, Aaron Seth; Burns, Alistair

2008-11-01

To evaluate the effectiveness of a combination of cholinesterase inhibitor therapy for patients with Alzheimer disease (AD) and psychosocial intervention, for their spouse caregivers compared with drug treatment alone in three countries simultaneously. Randomized controlled trial. Structured questionnaires were administered at baseline and at regular follow-up intervals for 24 months by independent raters blind to group assignment. Outpatient research clinics in New York City, U.S., Manchester, U.K. and Sydney, Australia. Volunteer sample of 158 spouse caregivers of community dwelling patients with AD. Five sessions of individual and family counseling within 3 months of enrollment and continuous availability of ad hoc telephone counseling were provided for half the caregivers. Donepezil was prescribed for all patients. Depressive symptoms of spouse caregivers measured at intake and follow-up assessments for 24 months using Beck Depression Inventory (revised). Depression scores of caregivers who received counseling decreased over time, whereas the depression scores for caregivers who did not receive counseling increased. The benefit of the psychosocial intervention was significant after controlling for site, gender and country was not accounted for by antidepressant use and increased over 2 years even though the individual and family counseling sessions occurred in the first 3 months. Effective counseling and support interventions can reduce symptoms of depression in caregivers when patients are taking donepezil. Harmonized multinational psychosocial interventions are feasible. Combined drug and supportive care approaches to the management of people with AD should be a priority.

Role of the multinational corporations in Nigeria's development

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

Okonkwo, P.A.

1978-01-01

A dominant characteristic of the decades immediately following World War II is the evolution of the multinational corporation. This evolution necessitated a change in the perspective of the international companies. The survival of the multinational corporations depended on its world profit perspective. Initially, the European countries provided the American multinational with world trade avenues while the European multinationals established subsidiaries in Africa. Recently, both the American and the European subsidiares have become interested in Nigeria because of its prospect as a potential market in Africa. The major objective of the research is to inquire about executive judgements and decision criteriamore » for marketing mix considerations and decisions. Also because of the uniqueness of Nigeria from the Western World in terms of its socio-cultural, legal, economic and political environments,executive decision criteria in the area of manufacturing was also investigated.« less

Challenges in randomized controlled trials and emerging multiple sclerosis therapeutics.

PubMed

Huang, DeRen

2015-12-01

The remarkable global development of disease-modifying therapies (DMTs) specific for multiple sclerosis (MS) has significantly reduced the frequency of relapse, slowed the progression of disability, and improved the quality of life in patients with MS. With increasing numbers of approved DMTs, neurologists in North America and Europe are able to present multiple treatment options to their patients to achieve a better therapeutic outcome, and in many cases, no evidence of disease activity. MS patients have improved accessibility to various DMTs at no or minimal out-of-pocket cost. The ethical guidelines defined by the Edinburgh revision of the Declaration of Helsinki strongly discourage the use of placebo control groups in modern MS clinical trials. The use of an active comparator control group increases the number of participants in each group that is essential to achieve statistical significance, thus further increasing the difficulty of completing randomized controlled trials (RCTs) for the development of new MS therapies. There is evidence of a high prevalence of MS and a large number of patients in Asia. The belief of the existence of Asian types of MS that are distinct from Western types, and regulatory policies are among the reasons why DMTs are limited in most Asian countries. Lack of access to approved DMTs provides a good opportunity for clinical trials that are designed for the development of new MS therapies. Recently, data from RCTs have demonstrated excellent recruitment of participants and the completion of multi-nation and single-nation MS trials within this region. Recent studies using the McDonald MS diagnostic criteria carefully excluded patients with neuromyelitis optica (NMO) and NMO spectrum disorder, and demonstrated that patients with MS in Asia have clinical characteristics and treatment responses similar to those in Western countries.

Insights, attitudes and perceptions about asthma and its treatment: findings from a multinational survey of patients from 8 Asia-Pacific countries and Hong Kong.

PubMed

Thompson, Philip J; Salvi, Sundeep; Lin, Jiangtao; Cho, Young Joo; Eng, Philip; Abdul Manap, Roslina; Boonsawat, Watchara; Hsu, Jeng-Yuan; Faruqi, Rab A; Moreno-Cantu, Jorge J; Fish, James E; Ho, James Chung-Man

2013-08-01

The Asthma Insight and Management (AIM) survey was conducted in North America, Europe, the Asia-Pacific region and Latin America to characterize patients' insights, attitudes and perceptions about their asthma and its treatment. We report findings from the Asia-Pacific survey. Asthma patients (≥12 years) from Australia, China, Hong Kong, India, Malaysia, Singapore, South Korea, Taiwan and Thailand were surveyed. Patients answered 53 questions exploring general health, diagnosis/history, symptoms, exacerbations, patient burden, disease management, medications/treatments and patient's attitudes. The Global Initiative for Asthma guidelines were used to assess asthma control. The survey was conducted by random digit telephone dialling (Australia, China and Hong Kong) or by random face-to-face interviews (India, Malaysia, Singapore, South Korea, Taiwan and Thailand). There were 80 761 households screened. Data from 3630 patients were collected. Wide disparity existed between objective measures of control and patient perception. Reported exacerbations during the previous year ranged from 19% (Hong Kong) to 67% (India). Reported unscheduled urgent/emergency visits to a doctor's office/hospital/clinic in the previous year ranged from 15% (Hong Kong) to 46% (Taiwan). Patients who reported having controlled asthma in the previous month ranged from 27% (South Korea) to 84% (Taiwan). Substantial functional and emotional limitations due to asthma were identified by 13% (South Korea) to 78% (India) of patients. Asthma has a profound impact on patients' well-being despite the availability of effective treatments and evidence-based management guidelines. Substantial differences across the surveyed countries exist, suggesting unmet, country-specific cultural and educational needs. A large proportion of asthma patients overestimate their level of control. © 2013 The Authors. Respirology © 2013 Asian Pacific Society of Respirology.

Technology Transfer: A Third World Perspective.

ERIC Educational Resources Information Center

Akubue, Anthony I.

2002-01-01

Technology transfer models are based on assumptions that do not reflect Third-World realities. Obstacles to building indigenous technology capacity include multinational corporations' control of innovations, strings attached to foreign aid, and indigenous reluctance to undertake research. Four areas of development include foreign direct…

Maritime Tactical Command and Control Analysis of Alternatives

DTIC Science & Technology

2016-01-01

JIIM joint, interagency, intergovernmental, and multinational LCC life-cycle cost MANA Map Aware Non-Uniform Automata MDA milestone decision authority...Map Aware Non-Uniform Automata (MANA), a combat and C4I, surveillance, and reconnaissance model developed by the New Zealand Defence Technology

Application status and its affecting factors of double standard for multinational corporations in Korea.

PubMed

Ki, Myung; Choi, Jaewook; Lee, Juneyoung; Park, Heechan; Yoon, Seokjoon; Kim, Namhoon; Heo, Jungyeon

2004-02-01

We intended to evaluate the double standard status and to identify factors of determining double standard criteria in multinational corporations of Korea, and specifically those in the occupational health and safety area. A postal questionnaire had been sent, between August 2002 and September 2002, to multinational corporations in Korea. A double standard company was defined as those who answered in more than one item as adopting a different standard among the five items regarding double standard identification. By comparing double standard companies with equivalent standard companies, determinants for double standards were then identified using logistic regression analysis. Of multinational corporations, 45.1% had adopted a double standard. Based on the question naire's scale level, the factor of 'characteristic and size of multinational corporation' was found to have the most potent impact on increasing double standard risk. On the variable level, factors of 'number of affiliated companies' and 'existence of an auditing system with the parent company' showed a strong negative impact on double standard risk. Our study suggests that a distinctive approach is needed to manage the occupational safety and health for multinational corporations. This approach should be focused on the specific level of a corporation, not on a country level.

Advances in damage control resuscitation and surgery: implications on the organization of future military field forces

PubMed Central

Tien, Col Homer; Beckett, Maj Andrew; Garraway, LCol Naisan; Talbot, LCol Max; Pannell, Capt Dylan; Alabbasi, Thamer

2015-01-01

Medical support to deployed field forces is increasingly becoming a shared responsibility among allied nations. National military medical planners face several key challenges, including fiscal restraints, raised expectations of standards of care in the field and a shortage of appropriately trained specialists. Even so, medical services are now in high demand, and the availability of medical support may become the limiting factor that determines how and where combat units can deploy. The influence of medical factors on operational decisions is therefore leading to an increasing requirement for multinational medical solutions. Nations must agree on the common standards that govern the care of the wounded. These standards will always need to take into account increased public expectations regarding the quality of care. The purpose of this article is to both review North Atlantic Treaty Organization (NATO) policies that govern multinational medical missions and to discuss how recent scientific advances in prehospital battlefield care, damage control resuscitation and damage control surgery may inform how countries within NATO choose to organize and deploy their field forces in the future. PMID:26100784

The Effectiveness and Safety of a Homeopathic Medicinal Product in Pediatric Upper Respiratory Tract Infections With Fever

PubMed Central

van Haselen, Robert; Thinesse-Mallwitz, Manuela; Maidannyk, Vitaliy; Buskin, Stephen L.; Weber, Stephan; Keller, Thomas; Burkart, Julia; Klement, Petra

2016-01-01

We investigated the clinical effectiveness of a homeopathic add-on therapy in a pediatric subpopulation with upper respiratory tract infections (URTI) in a randomized, controlled, multinational clinical trial. Patients received either on-demand symptomatic standard treatment (ST-group) or the same ST plus a homeopathic medication (Influcid; IFC-group) for 7 days. Outcome assessment was based on symptom and fever resolution and the Wisconsin Upper Respiratory Symptom Survey–21 (WURSS-21). A total of 261 pediatric (<12 years) patients (130 IFC-group; 131 ST-group) were recruited in Germany and the Ukraine. The IFC-group used less symptomatic medication, symptoms resolved significantly earlier (P = .0001), had higher proportions of fever-free children from day 3 onwards, and the WURSS-assessed global disease severity was significantly less (P < .0001) during the entire URTI episode. One adverse event (vomiting) was possibly related to IFC. IFC as add-on treatment in pediatric URTI reduced global disease severity, shortened symptom resolution, and was safe in use. PMID:27493984

Implementation of graphic health warning labels on tobacco products in India: the interplay between the cigarette and the bidi industries.

PubMed

Sankaran, Sujatha; Hiilamo, Heikki; Glantz, Stanton A

2015-11-01

To understand the competition between and among tobacco companies and health groups that led to graphical health warning labels (GHWL) on all tobacco products in India. Analysis of internal tobacco industry documents in the Legacy Tobacco Document Library, documents obtained through India's Right to Information Act, and news reports. Implementation of GHWLs in India reflects a complex interplay between the government and the cigarette and bidi industries, who have shared as well as conflicting interests. Joint lobbying by national-level tobacco companies (that are foreign subsidiaries of multinationals) and local producers of other forms of tobacco blocked GHWLs for decades and delayed the implementation of effective GHWLs after they were mandated in 2007. Tobacco control activists used public interest lawsuits and the Right to Information Act to win government implementation of GHWLs on cigarette, bidi and smokeless tobacco packs in May 2009 and rotating GHWLs in December 2011. GHWLs in India illustrate how the presence of bidis and cigarettes in the same market creates a complex regulatory environment. The government imposing tobacco control on multinational cigarette companies led to the enforcement of regulation on local forms of tobacco. As other developing countries with high rates of alternate forms of tobacco use establish and enforce GHWL laws, the tobacco control advocacy community can use pressure on the multinational cigarette industry as an indirect tool to force implementation of regulations on other forms of tobacco. 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/

Application of Standard Project Management Tools to Research--A Case Study from a Multi-National Clinical Trial

ERIC Educational Resources Information Center

Gist, Peter; Langley, David

2007-01-01

PRINCE2, which stands for Projects in Controlled Environments, is a project management method covering the organisation, management, and control of projects and is widely used in both government and commercial IT and building projects in the UK. This paper describes the application of PRINCE2 to the management of large clinical trials…

The Army in Multinational Operations

DTIC Science & Technology

2010-05-01

multinational commanders may be faced with nations refusing to perform assigned tasks. The term “national red card” using a soccer simile has been coined...106. What is the multinational plan for recovery of critical aviation equipment, facilities, and resources? Constraints and Freedom of Action 5-107...quantity, and timeliness) suitable for likely combat search and rescue as well as recovery of encircled forces? Operations and Planning 20 May

Cardiopoietic cell therapy for advanced ischaemic heart failure: results at 39 weeks of the prospective, randomized, double blind, sham-controlled CHART-1 clinical trial.

PubMed

Bartunek, Jozef; Terzic, Andre; Davison, Beth A; Filippatos, Gerasimos S; Radovanovic, Slavica; Beleslin, Branko; Merkely, Bela; Musialek, Piotr; Wojakowski, Wojciech; Andreka, Peter; Horvath, Ivan G; Katz, Amos; Dolatabadi, Dariouch; El Nakadi, Badih; Arandjelovic, Aleksandra; Edes, Istvan; Seferovic, Petar M; Obradovic, Slobodan; Vanderheyden, Marc; Jagic, Nikola; Petrov, Ivo; Atar, Shaul; Halabi, Majdi; Gelev, Valeri L; Shochat, Michael K; Kasprzak, Jaroslaw D; Sanz-Ruiz, Ricardo; Heyndrickx, Guy R; Nyolczas, Noémi; Legrand, Victor; Guédès, Antoine; Heyse, Alex; Moccetti, Tiziano; Fernandez-Aviles, Francisco; Jimenez-Quevedo, Pilar; Bayes-Genis, Antoni; Hernandez-Garcia, Jose Maria; Ribichini, Flavio; Gruchala, Marcin; Waldman, Scott A; Teerlink, John R; Gersh, Bernard J; Povsic, Thomas J; Henry, Timothy D; Metra, Marco; Hajjar, Roger J; Tendera, Michal; Behfar, Atta; Alexandre, Bertrand; Seron, Aymeric; Stough, Wendy Gattis; Sherman, Warren; Cotter, Gad; Wijns, William

2017-03-01

Cardiopoietic cells, produced through cardiogenic conditioning of patients' mesenchymal stem cells, have shown preliminary efficacy. The Congestive Heart Failure Cardiopoietic Regenerative Therapy (CHART-1) trial aimed to validate cardiopoiesis-based biotherapy in a larger heart failure cohort. This multinational, randomized, double-blind, sham-controlled study was conducted in 39 hospitals. Patients with symptomatic ischaemic heart failure on guideline-directed therapy (n = 484) were screened; n = 348 underwent bone marrow harvest and mesenchymal stem cell expansion. Those achieving > 24 million mesenchymal stem cells (n = 315) were randomized to cardiopoietic cells delivered endomyocardially with a retention-enhanced catheter (n = 157) or sham procedure (n = 158). Procedures were performed as randomized in 271 patients (n = 120 cardiopoietic cells, n = 151 sham). The primary efficacy endpoint was a Finkelstein-Schoenfeld hierarchical composite (all-cause mortality, worsening heart failure, Minnesota Living with Heart Failure Questionnaire score, 6-min walk distance, left ventricular end-systolic volume, and ejection fraction) at 39 weeks. The primary outcome was neutral (Mann-Whitney estimator 0.54, 95% confidence interval [CI] 0.47-0.61 [value > 0.5 favours cell treatment], P = 0.27). Exploratory analyses suggested a benefit of cell treatment on the primary composite in patients with baseline left ventricular end-diastolic volume 200-370 mL (60% of patients) (Mann-Whitney estimator 0.61, 95% CI 0.52-0.70, P = 0.015). No difference was observed in serious adverse events. One (0.9%) cardiopoietic cell patient and 9 (5.4%) sham patients experienced aborted or sudden cardiac death. The primary endpoint was neutral, with safety demonstrated across the cohort. Further evaluation of cardiopoietic cell therapy in patients with elevated end-diastolic volume is warranted. © The Author 2016. Published by Oxford University Press on behalf of the European Society of Cardiology.

Efficacy and tolerability of saxagliptin compared with glimepiride in elderly patients with type 2 diabetes: a randomized, controlled study (GENERATION).

PubMed

Schernthaner, G; Durán-Garcia, S; Hanefeld, M; Langslet, G; Niskanen, L; Östgren, C J; Malvolti, E; Hardy, E

2015-07-01

To assess the efficacy and safety of adjunctive saxagliptin vs glimepiride in elderly patients with type 2 diabetes (T2D) and inadequate glycaemic control. In this multinational, randomized, double-blind, phase IIIb/IV study (GENERATION; NCT01006603), patients aged ≥65 years were randomized (1 : 1) to receive saxagliptin 5 mg/day or glimepiride ≤6 mg/day, added to metformin, during a 52-week treatment period. The primary endpoint was achievement of glycated haemoglobin (HbA1c) <7.0% at week 52 without confirmed/severe hypoglycaemia. The key secondary endpoint was incidence of confirmed/severe hypoglycaemia. Safety and tolerability were also assessed. Of 720 patients randomized (360 in each treatment group; mean age 72.6 years; mean T2D duration 7.6 years), 574 (79.8%) completed the study (saxagliptin 80.3%; glimepiride 79.2%). Similar proportions of patients achieved the primary endpoint with saxagliptin and glimepiride (37.9 vs 38.2%; odds ratio 0.99, 95% confidence interval 0.73, 1.34; p = 0.9415); however, a significant treatment-by-age interaction effect was detected (p = 0.0389): saxagliptin was numerically (but not significantly) superior to glimepiride for patients aged <75 years (39.2 vs 33.3%) and numerically inferior for patients aged ≥75 years (35.9 vs 45.5%). The incidence of confirmed/severe hypoglycaemia was lower with saxagliptin vs glimepiride (1.1 vs 15.3%; nominal p < 0.0001). Saxagliptin was generally well tolerated, with similar incidences of adverse events compared with glimepiride. As avoiding hypoglycaemia is a key clinical objective in elderly patients, saxagliptin is a suitable alternative to glimepiride in patients with T2D aged ≥65 years. © 2015 John Wiley & Sons Ltd.

Cardiopoietic cell therapy for advanced ischaemic heart failure: results at 39 weeks of the prospective, randomized, double blind, sham-controlled CHART-1 clinical trial

PubMed Central

Bartunek, Jozef; Terzic, Andre; Davison, Beth A.; Filippatos, Gerasimos S.; Radovanovic, Slavica; Beleslin, Branko; Merkely, Bela; Musialek, Piotr; Wojakowski, Wojciech; Andreka, Peter; Horvath, Ivan G.; Katz, Amos; Dolatabadi, Dariouch; El Nakadi, Badih; Arandjelovic, Aleksandra; Edes, Istvan; Seferovic, Petar M.; Obradovic, Slobodan; Vanderheyden, Marc; Jagic, Nikola; Petrov, Ivo; Atar, Shaul; Halabi, Majdi; Gelev, Valeri L.; Shochat, Michael K.; Kasprzak, Jaroslaw D.; Sanz-Ruiz, Ricardo; Heyndrickx, Guy R.; Nyolczas, Noémi; Legrand, Victor; Guédès, Antoine; Heyse, Alex; Moccetti, Tiziano; Fernandez-Aviles, Francisco; Jimenez-Quevedo, Pilar; Bayes-Genis, Antoni; Hernandez-Garcia, Jose Maria; Ribichini, Flavio; Gruchala, Marcin; Waldman, Scott A.; Teerlink, John R.; Gersh, Bernard J.; Povsic, Thomas J.; Henry, Timothy D.; Metra, Marco; Hajjar, Roger J.; Tendera, Michal; Behfar, Atta; Alexandre, Bertrand; Seron, Aymeric; Stough, Wendy Gattis; Sherman, Warren; Cotter, Gad; Wijns, William

2017-01-01

Aims Cardiopoietic cells, produced through cardiogenic conditioning of patients’ mesenchymal stem cells, have shown preliminary efficacy. The Congestive Heart Failure Cardiopoietic Regenerative Therapy (CHART-1) trial aimed to validate cardiopoiesis-based biotherapy in a larger heart failure cohort. Methods and results This multinational, randomized, double-blind, sham-controlled study was conducted in 39 hospitals. Patients with symptomatic ischaemic heart failure on guideline-directed therapy (n = 484) were screened; n = 348 underwent bone marrow harvest and mesenchymal stem cell expansion. Those achieving > 24 million mesenchymal stem cells (n = 315) were randomized to cardiopoietic cells delivered endomyocardially with a retention-enhanced catheter (n = 157) or sham procedure (n = 158). Procedures were performed as randomized in 271 patients (n = 120 cardiopoietic cells, n = 151 sham). The primary efficacy endpoint was a Finkelstein–Schoenfeld hierarchical composite (all-cause mortality, worsening heart failure, Minnesota Living with Heart Failure Questionnaire score, 6-min walk distance, left ventricular end-systolic volume, and ejection fraction) at 39 weeks. The primary outcome was neutral (Mann–Whitney estimator 0.54, 95% confidence interval [CI] 0.47–0.61 [value > 0.5 favours cell treatment], P = 0.27). Exploratory analyses suggested a benefit of cell treatment on the primary composite in patients with baseline left ventricular end-diastolic volume 200–370 mL (60% of patients) (Mann–Whitney estimator 0.61, 95% CI 0.52–0.70, P = 0.015). No difference was observed in serious adverse events. One (0.9%) cardiopoietic cell patient and 9 (5.4%) sham patients experienced aborted or sudden cardiac death. Conclusion The primary endpoint was neutral, with safety demonstrated across the cohort. Further evaluation of cardiopoietic cell therapy in patients with elevated end-diastolic volume is warranted. PMID:28025189

Focused Logistics: Putting Agility in Agile Logistics

DTIC Science & Technology

2011-05-19

list, ahead of companies like American Express, DuPont and Coca Cola ; Supports nearly 1,900 weapon systems; DLA manages eight supply chains and...35 7) Force Health Protection...Distribution, Information Fusion, Joint Theater Logistics Command and Control, Multinational Logistics, Joint Health Services Support, and Agile

Effects of Demographics on the Antihypertensive Efficacy of Triple Therapy With Amlodipine, Valsartan, and Hydrochlorothiazide for Moderate to Severe Hypertension

PubMed Central

Calhoun, David A.; Lacourci00E8;re, Yves; Crikelair, Nora; Jia, Yan; Glazer, Robert D.

2014-01-01

Objective To compare the antihypertensive efficacy and safety of once-daily triple therapy with amlodipine (Aml) 10 mg, valsartan (Val) 320 mg, and hydrochlorothiazide (HCTZ) 25 mg versus dual-therapy combinations of these components in patients with moderate to severe hypertension. Research design Subgroup analysis of a multinational, randomized, double-blind, parallel-group, active-controlled trial. Methods After antihypertensive washout and a placebo run-in of up to 4 weeks, 2271 patients were randomly allocated in a 1:1:1:1 ratio to receive Aml/Val/HCTZ triple therapy or dual therapy with Val/HCTZ, Aml/Val, or Aml/HCTZ for 8 weeks. Forced titration to the full dose was done over the first 2 weeks of treatment. Efficacy and safety parameters were determined by age group (<65 vs. ≥65 years), gender, race (White vs. Black), ethnicity (Hispanic/Latino vs. non-Hispanic/Latino), and body mass index (BMI, <30 vs. ≥30 kg/m2). Main outcome measures Change from baseline to endpoint in mean sitting systolic blood pressure (MSSBP) and mean sitting diastolic blood pressure (MSDBP); blood pressure (BP) control rate <140/90 mmHg. Results Triple therapy was numerically superior and, for the majority of comparisons, statistically superior to each dual therapy in reducing MSSBP and MSDBP and in improving BP control rates in all subgroups. Across subgroups, triple therapy reduced MSSBP by 5.7–10.7 mmHg more than Val/HCTZ, 3.4–8.3 mmHg more than Aml/Val, and 4.4–9.4 mmHg more than Aml/HCTZ. Triple therapy was well tolerated across all subgroups. Limitations of our analysis included the lack of stratification of patients by subgroup at randomization and the small sample size of some subgroups (eg, Blacks, elderly). Conclusions Triple therapy with Aml/Val/HCTZ is effective and well tolerated in patients with moderate to severe hypertension regardless of age, gender, race, ethnicity, or BMI. PMID:23721363

Treatment of recent-onset type 1 diabetic patients with DiaPep277: results of a double-blind, placebo-controlled, randomized phase 3 trial.

PubMed

Raz, Itamar; Ziegler, Anette G; Linn, Thomas; Schernthaner, Guntram; Bonnici, Francois; Distiller, Larry A; Giordano, Carla; Giorgino, Francesco; de Vries, Liat; Mauricio, Didac; Procházka, Vlastimil; Wainstein, Julio; Elias, Dana; Avron, Ann; Tamir, Merana; Eren, Rachel; Peled, Dana; Dagan, Shlomo; Cohen, Irun R; Pozzilli, Paolo

2014-01-01

To evaluate safety and efficacy of DiaPep277 in preserving β-cell function in type 1 diabetic patients. DIA-AID 1 is a multinational, phase 3, balanced-randomized, double-blind, placebo-controlled, parallel-group clinical study. Newly diagnosed patients (N = 457, aged 16-45 years) were randomized to subcutaneous injections of DiaPep277 or placebo quarterly for 2 years. The primary efficacy end point was the change from baseline in the area under the glucagon-stimulated C-peptide curve. Secondary end points were the change from baseline in mixed-meal stimulated C-peptide secretion and in fasting C-peptide and achieving target HbA1c ≤7% (≤53 mmol/mol). Partial remission (target HbA1c on insulin ≤0.5 units/kg/day) and hypoglycemic event rate were exploratory end points. DiaPep277 was safe and well tolerated. Significant preservation of C-peptide secretion was observed in the DiaPep277-treated group compared with the placebo (relative treatment effects of 23.4%, P = 0.037, and 29.2%, P = 0.011, in the modified intent-to-treat [mITT] and per-protocol [PP] populations, respectively). The mixed-meal stimulation failed to distinguish between the groups. There was a trend toward efficacy in fasting C-peptide levels, though not statistically significant. Significantly more DiaPep277-treated than placebo-treated patients maintained target HbA1c (mITT 56% versus 44%, P = 0.03; PP 60% versus 45%, P = 0.0082) and entered partial remission (mITT 38% versus 29%, P = 0.08; PP 42% versus 30%, P = 0.035). DiaPep277 treatment reduced the relative hypoglycemic event risk (mITT by 20%; PP by 28%). DiaPep277 safely contributes to preservation of β-cell function and to improved glycemic control in patients with type 1 diabetes.

Gaming Sea-based Multinational HA/DR Operations at PACOM Amphibious Leaders Symposium 2016

DTIC Science & Technology

2016-11-01

DISTRIBUTION STATEMENT A. Approved for public release: distribution unlimited. Gaming Sea-based Multinational HA/DR Operations...Marine Corps photo by Cpl. Wesley Timm. Approved by: November 2016 Dr. E.D. McGrady Director, Integration and Gaming Advanced Technology and...TYPE Final2 3. DATES COVERED (From - To) 4. TITLE AND SUBTITLE Gaming Seabased Multinational HA/DR Operations at PACOM 5a. CONTRACT NUMBER N00014-16

Stilwell’s North Burma campaign: a case study in multinational mission command

DTIC Science & Technology

2017-05-25

history of providing multinational leadership , publications from the Army Press and Combat Studies Institute have not explored the use of the mission...the campaign. His leadership aided the US effort to reestablish its ground line of communication with its Chinese Nationalist allies. Stilwell’s...history of providing multinational leadership , publications from the Army Press and Combat Studies Institute have not explored the use of the mission

Globalization of Science Education: Comment and a Commentary

ERIC Educational Resources Information Center

Fensham, Peter J.

2011-01-01

The globalized nature of modern society has generated a number of pressures that impact internationally on countries' policies and practices of science education. Among these pressures are key issues of health and environment confronting global science, global economic control through multi-national capitalism, comparative and competitive…

Globally Sustainable Management: A Dynamic Model of IHRM Learning and Control

ERIC Educational Resources Information Center

Takeda, Margaret B.; Helms, Marilyn M.

2010-01-01

Purpose: After a thorough literature review on multinational learning, it is apparent organizations "learn" when they capitalize on expatriate management, a "learning strategy" (international work teams, employee involvement and other human resource policies), technology transfer and political environment and cross-cultural adaptation. This…

Coalition Logistics - The Multinational Force and Observers Model

DTIC Science & Technology

1986-05-19

MISSION The mission of the MFO, as specified by the protocol , is to supervise implemeutation of the peace treaty and to employ its best efforts to prevent ...result, a protocol was -- negotiated, calling for a multinational military force and civilian- ---- observer unit to serve in the Sinai--outside the...auspices of the United Nations.2 In this way, the protocol of 3 August 1981 created the Multinational Force and Observers and directed Lhat it be

Job strain among Malaysian office workers of a multinational company.

PubMed

Maizura, H; Retneswari, M; Moe, H; Hoe, V C W; Bulgiba, A

2010-05-01

Information on job strain exposure among Malaysian workers in multinational companies is limited. To investigate the prevalence and factors associated with high job strain among office workers of a multinational company in Malaysia. A cross-sectional study was conducted in November 2007 among 470 eligible workers. Respondents self-administered the Job Content Questionnaire downloaded from the company's intranet. A median-split procedure was applied to create four groups according to the Job Demand-Control Model: active, passive, high and low job strain. Logistic regression models were used to investigate the associations between socio-demographic, occupational and psychosocial factors and high job strain. A total of 356 questionnaires were received (response rate 76%). Twenty-one per cent of respondents were in the high job strain group, 35% were in the passive group, whereas 26% and 17% of workers were in the low strain and active groups, respectively. After controlling for confounders, three factors were found to be associated with high job strain: male workers (adjusted OR 1.94, 95% CI 1.04-3.64), working >48 h per week (adjusted OR 2.51, 95% CI 1.44-4.39) and job insecurity (adjusted OR 1.14, 95% CI 1.02-1.27). One protective factor for high job strain was the scale 'created skill', which is part of skill discretion (adjusted OR 0.70, 95% CI 0.57-0.86). About one in five workers in this study experience high job strain. Work improvement measures include reducing long working hours and job insecurity and giving workers the opportunity to learn, use creativity and develop abilities.

Rationale and design of the SERVE-HF study: treatment of sleep-disordered breathing with predominant central sleep apnoea with adaptive servo-ventilation in patients with chronic heart failure.

PubMed

Cowie, Martin R; Woehrle, Holger; Wegscheider, Karl; Angermann, Christiane; d'Ortho, Marie-Pia; Erdmann, Erland; Levy, Patrick; Simonds, Anita; Somers, Virend K; Zannad, Faiez; Teschler, Helmut

2013-08-01

Central sleep apnoea/Cheyne-Stokes respiration (CSA/CSR) is a risk factor for increased mortality and morbidity in heart failure (HF). Adaptive servo-ventilation (ASV) is a non-invasive ventilation modality for the treatment of CSA/CSR in patients with HF. SERVE-HF is a multinational, multicentre, randomized, parallel trial designed to assess the effects of addition of ASV (PaceWave, AutoSet CS; ResMed) to optimal medical management compared with medical management alone (control group) in patients with symptomatic chronic HF, LVEF ≤45%, and predominant CSA. The trial is based on an event-driven group sequential design, and the final analysis will be performed when 651 events have been observed or the study is terminated at one of the two interim analyses. The aim is to randomize ∼1200 patients to be followed for a minimum of 2 years. Patients are to stay in the trial up to study termination. The first patient was randomized in February 2008 and the study is expected to end mid 2015. The primary combined endpoint is the time to first event of all-cause death, unplanned hospitalization (or unplanned prolongation of a planned hospitalization) for worsening (chronic) HF, cardiac transplantation, resuscitation of sudden cardiac arrest, or appropriate life-saving shock for ventricular fibrillation or fast ventricular tachycardia in implantable cardioverter defibrillator patients. The SERVE-HF study is a randomized study that will provide important data on the effect of treatment with ASV on morbidity and mortality, as well as the cost-effectiveness of this therapy, in patients with chronic HF and predominantly CSA/CSR. ISRCTN19572887.

Multinational corporations and culture in Liberia

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

Bonaparte, T.H.

1979-07-01

The proportion of multinational corporations (MCs) in a developing country (DC) has little to do with the degree of corruption of local culture that takes place. Rather, policy decisions taken by governments of DCs determine whether or not multinationals have a positive or negative impact, according to the author's research in Liberia among foreign managers, African supervisors, and Liberian workers. Even though Liberia has an open door policy toward MCs, very little violence has been done to Liberian culture. The reason is two-fold: 1) multinationals have maintained tight enclaves and have generally refused to integrate their values, managerial and otherwise,more » with those of the Liberian society; and 2) Liberian government officials have done little to generate Liberian interest in the business field or to force multinationals to play a more participative role in the society. The result has been growth without development, in the sense that the country's growth rate has increased over the years, but the Liberian people remain very much underdeveloped. A change of policy could bring about continued growth with development and without cultural disintegration.« less

The roles of information technology in global chain supply: a multiple case study of multinational companies of China

NASA Astrophysics Data System (ADS)

He, Mao; Duan, Wanchun

2007-12-01

Nowadays many Chinese companies have being becoming more and more international. Therefore, these Chinese companies have to face global supply chains rather than the former domestic ones. The use of information technology (IT) is considered a prerequisite for the effective control of today's complex global supply chains. Based on empirical data from 10 multinational companies of China, this paper presents a classification of the ways in which companies use IT in SCM, and examines the drivers for these different utilization types. According to the findings of this research, the purposes of using of IT in SCM can be divided into 1) transaction processing, 2) supply chain planning and collaboration, and 3) order tracking and delivery coordination. The findings further suggest that the drivers between these three uses of IT in SCM differ.

Multinational Military Operations and Intercultural Factors (Les Operations Militaires Multinationales et les Facteurs Interculturels)

DTIC Science & Technology

2008-11-01

of 115 hypothesis tests . Journal of Experimental Social Psychology , 21, 262-283. [32] Nemeth, C.J. (1986). Differential contributions of majority...military command and control, military training and selection, and cross-cultural and social psychology . The present report was not meant to be...military command and control, military training and selection, and cross-cultural and social psychology . Participants included researchers from Defence

32 CFR 268.9 - Discussion of terms.

Code of Federal Regulations, 2010 CFR

2010-07-01

..., excepting branches or agencies thereof located in the United States. (3) Any branch, subsidiary, or allied... organization of a multinational or regional character with headquarters abroad. (6) Any official multinational...

A phase 3 randomized controlled trial of the efficacy and safety of atrasentan in men with metastatic hormone-refractory prostate cancer.

PubMed

Carducci, Michael A; Saad, Fred; Abrahamsson, Per-Anders; Dearnaley, David P; Schulman, Claude C; North, Scott A; Sleep, Darryl J; Isaacson, Jeffrey D; Nelson, Joel B

2007-11-01

The objective of this study was to evaluate the efficacy and safety of atrasentan (Xinlay), a selective endothelin-A receptor antagonist, in patients with metastatic hormone-refractory prostate cancer (HRPC). This multinational, double-blind, placebo-controlled trial enrolled 809 men with metastatic HRPC. Patients were randomized 1:1 to receive either atrasentan 10 mg per day or placebo. The primary endpoint was time to disease progression (TTP), which was determined according to radiographic and clinical measures. Analyses of overall survival and changes in biomarkers also were performed. Atrasentan did not reduce the risk of disease progression relative to placebo (hazards ratio, 0.89; 95% confidence interval, 0.76-1.04; P = .136). Most patients progressed radiographically at the first 12-week bone scan without concomitant clinical progression. In exploratory analyses, increases from baseline to final bone alkaline phosphatase (BAP) and prostate-specific antigen (PSA) levels were significantly lower with atrasentan treatment (P < .05 for each). The median time to BAP progression (>/=50% increase from nadir) was twice as long with atrasentan treatment (505 days vs 254 days; P < .01). The delay in time to PSA progression did not reach statistical significance. Atrasentan generally was tolerated well, and the most common adverse events associated with treatment were headache, rhinitis, and peripheral edema, reflecting the vasodilatory and fluid-retention properties of endothelin-A receptor antagonism. Atrasentan did not delay disease progression in men with metastatic HRPC despite evidence of biologic effects on PSA and BAP as markers of disease burden.

Research: Treatment Study to determine the durability of glycaemic control with early treatment with a vildagliptin–metformin combination regimen vs. standard-of-care metformin monotherapy—the VERIFY trial: a randomized double-blind trial

PubMed Central

Del Prato, S; Foley, J E; Kothny, W; Kozlovski, P; Stumvoll, M; Paldánius, P M; Matthews, D R

2014-01-01

Aims Durability of good glycaemic control (HbA1c) is of importance as it can be the foundation for delaying diabetic complications. It has been hypothesized that early initiation of treatment with the combination of oral anti-diabetes agents with complementary mechanisms of action can increase the durability of glycaemic control compared with metformin monotherapy followed by a stepwise addition of oral agents. Dipeptidyl peptidase-4 inhibitors are good candidates for early use as they are efficacious in combination with metformin, show weight neutrality and a low risk of hypoglycaemia. We aimed to test the hypothesis that early combined treatment of metformin and vildagliptin slows β-cell deterioration as measured by HbA1c. Methods Approximately 2000 people with Type 2 diabetes mellitus who were drug-naive or who were treated with metformin for less than 1 month, and who have HbA1c of 48–58 mmol/mol (6.5–7.5%), will be randomized in a 1:1 ratio in VERIFY, a 5-year multinational, double-blind, parallel-group study designed to compare early initiation of a vildagliptin–metformin combination with standard-of-care initiation of metformin monotherapy, followed by the stepwise addition of vildagliptin when glycaemia deteriorates. Further deterioration will be treated with insulin. The primary analysis for treatment failure will be from a Cox proportional hazard regression model and the durability of glycaemic control will be evaluated by assessing treatment failure rate and the rate of loss in glycaemic control over time as co-primary endpoints. Summary VERIFY is the first study to investigate the long-term clinical benefits of early combination treatment vs. the standard-of-care metformin monotherapy with a second agent added by threshold criteria. PMID:24863949

IFLA General Conference, 1985. Division of Bibliographic Control. Sections on Bibliography, Cataloging, and Classification. Papers.

ERIC Educational Resources Information Center

International Federation of Library Associations, The Hague (Netherlands).

Papers on cataloging and classification which were presented at the 1985 International Federation of Library Associations (IFLA) conference include: (1) "Online Cataloging at the Bibliotheque Nationale (Francoise Finelli and Serge Salomon, France); (2) "Development of National Press Repertoire in the Condition of Multinational State: Its…

Role of Special Forces Liaison Elements in Future Multinational Operations

DTIC Science & Technology

2002-05-01

SOF simply with UW and the “old special-ops bugaboo of poor command and control and lack of coordination” that was displayed during Desert One, the...funding and allocating time for training and education in the areas of cultural, tactical, and technical expertise is not only a good investment for

Home telemonitoring in heart failure patients: the HHH study (Home or Hospital in Heart Failure)

PubMed Central

Mortara, Andrea; Pinna, Gian Domenico; Johnson, Paul; Maestri, Roberto; Capomolla, Soccorso; La Rovere, Maria Teresa; Ponikowski, Piotr; Tavazzi, Luigi; Sleight, Peter

2009-01-01

Aims The Home or Hospital in Heart failure (HHH) study was a European Community-funded, multinational, randomized controlled clinical trial, conducted in the UK, Poland, and Italy, to assess the feasibility of a new system of home telemonitoring (HT). The HT system was used to monitor clinical and physiological parameters, and its effectiveness (compared with usual care) in reducing cardiac events in heart failure (HF) patients was evaluated. Measurements were patient-managed. Methods and results From 2002 to 2004, 461 HF patients (age 60 ± 11 years, New York Heart Association class 2.4 ± 0.6, left ventricular ejection fraction 29 ± 7%) were enrolled at 11 centres and randomized (1:2) to either usual outpatient care or HT administered as three randomized strategies: (i) monthly telephone contact; (ii) strategy 1 plus weekly transmission of vital signs; and (iii) strategy 2 plus monthly 24 h recording of cardiorespiratory activity. Patients completed 81% of vital signs transmissions, as well as 92% of cardiorespiratory recordings. Over a 12-month follow-up, there was no significant effect of HT in reducing bed-days occupancy for HF or cardiac death plus HF hospitalization. Post hoc analysis revealed a heterogeneous effect of HT in the three countries with a trend towards a reduction of events in Italy. Conclusion Home or Hospital in Heart failure indicates that self-managed HT of clinical and physiological parameters is feasible in HF patients, with surprisingly high compliance. Whether HT contributes to a reduction of cardiac events requires further investigation. PMID:19228800

Geographic variation in human papillomavirus–related oropharyngeal cancer: Data from 4 multinational randomized trials

PubMed Central

Franklin, Natalie; Compton, Natalie; Robinson, Max; Powell, Ned; Biswas–Baldwin, Nigel; Paleri, Vindh; Hartley, Andrew; Fresco, Lydia; Al‐Booz, Hoda; Junor, Elizabeth; El‐Hariry, Iman; Roberts, Sally; Harrington, Kevin; Ang, K. Kian; Dunn, Janet; Woodman, Ciaran

2016-01-01

Abstract Background There are variations in the proportions of head and neck cancers caused by the human papillomavirus (HPV) between countries and regions. It is unclear if these are true variations or due to different study designs and assays. Methods We tested formalin‐fixed paraffin‐embedded diagnostic biopsies for p16 immunohistochemistry and HPV‐DNA (by polymerase chain reaction [PCR] and in situ hybridization [ISH]) using validated protocols on samples from 801 patients with head and neck cancer recruited prospectively between 2006 and 2011 in 4 randomized controlled trials (RCTs). Results Twenty‐one percent of patients (170 of 801) showed both HPV‐DNA and p16‐positivity, detected almost exclusively in oropharyngeal cancer (55%; 15 of 302); and only 1% of the patients (5 of 499) with nonoropharyngeal cancer were HPV positive. HPV‐positive oropharyngeal cancer differed between Western and Eastern Europe (37%, 155 of 422 vs 6%, 8 of 144; p < .0001) and between Western Europe and Asia (37% vs 2%; 4 of 217; p < .0001). Other independent determinants of HPV positivity were tumor site and smoking. Conclusion This is the first study to establish geographic variability as an independent risk factor in HPV‐positive oropharyngeal cancer prevalence, with higher prevalence in Western Europe. © 2016 The Authors Head & Neck Published by Wiley Periodicals, Inc. Head Neck 38: E1863–E1869, 2016 PMID:26749143

The Cooperative Landscape of Multinational Clinical Trials

PubMed Central

Hsiehchen, David; Espinoza, Magdalena; Hsieh, Antony

2015-01-01

The scale and nature of cooperative efforts spanning geopolitical borders in clinical research have not been elucidated to date. In a cross-sectional study of 110,428 interventional trials registered in Clinicaltrials.gov, we characterized the evolution, trial demographics, and network properties of multinational clinical research. We reveal that the relative growth of international collaboratives has remained stagnant in the last two decades, although clinical trials have evolved to become much larger in scale. Multinational clinical trials are also characterized by higher patient enrollments, industry funding, and specific clinical disciplines including oncology and infectious disease. Network analyses demonstrate temporal shifts in collaboration patterns between countries and world regions, with developing nations now collaborating more within themselves, although Europe remains the dominant contributor to multinational clinical trials worldwide. Performances in network centrality measures also highlight the differential contribution of nations in the global research network. A city-level clinical trial network analysis further demonstrates how collaborative ties decline with physical distance. This study clarifies evolving themes and highlights potential growth mechanisms and barriers in multinational clinical trials, which may be useful in evaluating the role of national and local policies in organizing transborder efforts in clinical endeavors. PMID:26103155

Population-based strategies to control manufacturing epidemics.

PubMed

Gorini, Giuseppe

2017-01-01

"The multinational corporations producing tobacco, alcohol, soft drinks, and processed foods have a role of vectors in the increase of chronic diseases, so that one can speak of manufacturing epidemics. The main aim of this paper is to conduct a literature review on different approaches in population-based interventions to stem the rise in consumption of unhealthy products. Different approaches were found: • command-and-control regulations: the route is definitely more advanced for tobacco with the implementation of an international treaty, which requires 180 ratifying states to implement a series of tobacco control policies. Similar regulations have been partially adopted to reduce alcohol use and to increase taxes of sugar-sweetened beverages; • multinational corporations in few Countries can voluntarily adopt recommendations on media campaigns and on labelling of soft drinks and processed foods; • in order to reduce salt in foods, many Countries developed voluntary agreements with industries with monitoring systems to assess compliance. Population-based interventions to try to align the interests of multinational corporations with those of public health are described in literature: • the "Health Footprint" programme; • the performance-based regulation which could oblige industry to take responsibility to reduce the harmful consequences of the use of their unhealthy commodities; • the price-cap regulation, usually applied to the utilities sector, would set a cap on the price of the tobacco industry, raising the tobacco taxes by 500 million euros per year. In order to reduce the burden of chronic disease, one of the objectives of the Italian National Prevention Plan, a working group including non-governmental organizations and experts in communication, social marketing, and lifestyles should be organized by the Ministry of Health in order to identify which population-based interventions could be implemented in Italy in next years to stem the rise of consumption of unhealthy products. ".

“Does Organizational Culture Influence the Ethical Behavior in the Pharmaceutical Industry?”

PubMed Central

Nagashekhara, Molugulu; Agil, Syed Omar Syed

2011-01-01

Study of ethical behavior among medical representatives in the profession is an under-portrayed component that deserves further perusal in the pharmaceutical industry. The purpose of this study is to find out the influence of organizational culture on ethical behavior of medical representatives. Medical representatives working for both domestic and multinational companies constitutes the sample (n=300). Data is collected using a simple random and cluster sampling through a structured questionnaire. The research design is hypothesis testing. It is a cross-sectional and correlational study, conducted under non-contrived settings. Chi-square tests were shows that there is an association between the organizational culture and ethical behavior of medical representatives. In addition, the strength of the association is measured which report to Cramer’s V of 63.1% and Phi Value of 2.749. Results indicate that multinational company medical reps are more ethical compared to domestic company medical representatives vast difference in both variance and in t test results. Through better organizational culture, pharmaceutical companies can create the most desirable behavior among their employees. Authors conclude that apart from organizational culture, the study of additional organizational, individual and external factors are imperative for better understanding of ethical behavior of medical representatives in the pharmaceutical industry in India. PMID:24826027

"Does organizational culture influence the ethical behavior in the pharmaceutical industry?".

PubMed

Nagashekhara, Molugulu; Agil, Syed Omar Syed

2011-12-01

Study of ethical behavior among medical representatives in the profession is an under-portrayed component that deserves further perusal in the pharmaceutical industry. The purpose of this study is to find out the influence of organizational culture on ethical behavior of medical representatives. Medical representatives working for both domestic and multinational companies constitutes the sample (n=300). Data is collected using a simple random and cluster sampling through a structured questionnaire. The research design is hypothesis testing. It is a cross-sectional and correlational study, conducted under non-contrived settings. Chi-square tests were shows that there is an association between the organizational culture and ethical behavior of medical representatives. In addition, the strength of the association is measured which report to Cramer's V of 63.1% and Phi Value of 2.749. Results indicate that multinational company medical reps are more ethical compared to domestic company medical representatives vast difference in both variance and in t test results. Through better organizational culture, pharmaceutical companies can create the most desirable behavior among their employees. Authors conclude that apart from organizational culture, the study of additional organizational, individual and external factors are imperative for better understanding of ethical behavior of medical representatives in the pharmaceutical industry in India.

The effect of exemestane and tamoxifen on bone health within the Tamoxifen Exemestane Adjuvant Multinational (TEAM) trial: a meta-analysis of the US, German, Netherlands, and Belgium sub-studies.

PubMed

Hadji, Peyman; Asmar, Lina; van Nes, Johanna G H; Menschik, Thomas; Hasenburg, Annette; Kuck, Joachim; Nortier, Johan W R; van de Velde, Cornelis J H; Jones, Stephen E; Ziller, May

2011-06-01

We performed a meta-analysis of three sub-studies of the randomized Tamoxifen Exemestane Adjuvant Multinational (TEAM) trial to determine the effects of exemestane and tamoxifen on bone health. Patients received exemestane or tamoxifen as adjuvant therapy for hormone receptor-positive breast cancer. Bone mineral density (BMD) was assessed at baseline and after 12 and 24 months of treatment. Bone turnover markers were also measured. Patients receiving tamoxifen showed a mean increase from baseline in lumbar spine BMD of 1.2% at month 12 and 0.2% at month 24. Patients receiving exemestane showed a mean decrease from baseline of 2.6% after 12 months and 3.5% after 24 months. There were significant differences in the changes in lumbar spine BMD between treatment groups (P < 0.0001 at both time points). Changes in BMD from baseline at the total hip were also significantly different between exemestane and tamoxifen (P < 0.05 at both time points). Bone turnover markers decreased from baseline with tamoxifen and increased with exemestane. Exemestane resulted in decreases in BMD and increases in bone turnover markers. BMD increased and bone turnover markers decreased with tamoxifen.

Stemming the Flow of Improvised Explosive Device Making Materials through Global Export Control Regimes

DTIC Science & Technology

2012-09-01

reflect the official policy or position of the Department of Defense or the U.S. Government. IRB Protocol number ______N/A______. 12a. DISTRIBUTION...Warfare DHS Department of Homeland Security DoD Department of Defense DTMF Dual-Tone Multi-Frequency EOD Explosive Ordnance Disposal EU European...Organization JMTC Joint Multinational Training Command JTF Joint Task Force MANPADS Man Portable Air Defense Systems MERC Multilateral Export Control

The case for a multinational Mars Surveyor Program

NASA Astrophysics Data System (ADS)

Rea, D. G.; Carr, M. H.; Craig, M. K.

1989-10-01

A coordinated multinational Mars Surveyor Program involving a series of robotic missions is proposed in order to select worthwhile human landing sites for discoveries, for safe operations, and for testing and proving technologies for making human flight to Mars possible. Some characteristics motivating exploration of the planet are briefly discussed, including the possibility of life, geological features, and meteorological conditions. The necessity for preliminary exploration of Mars by robots prior to human exploration is discussed, and the rationale behind a multinational approach for a Mars Surveyor Program is presented.

Bardoxolone Methyl Improves Kidney Function in Patients with Chronic Kidney Disease Stage 4 and Type 2 Diabetes: Post-Hoc Analyses from Bardoxolone Methyl Evaluation in Patients with Chronic Kidney Disease and Type 2 Diabetes Study

PubMed Central

Chin, Melanie P.; Bakris, George L.; Block, Geoffrey A.; Chertow, Glenn M.; Goldsberry, Angie; Inker, Lesley A.; Heerspink, Hiddo J.L.; O'Grady, Megan; Pergola, Pablo E.; Wanner, Christoph; Warnock, David G.; Meyer, Colin J.

2018-01-01

Background Increases in measured inulin clearance, measured creatinine clearance, and estimated glomerular filtration rate (eGFR) have been observed with bardoxolone methyl in 7 studies enrolling approximately 2,600 patients with type 2 diabetes (T2D) and chronic kidney disease (CKD). The largest of these studies was Bardoxolone Methyl Evaluation in Patients with Chronic Kidney Disease and Type 2 Diabetes (BEACON), a multinational, randomized, double-blind, placebo-controlled phase 3 trial which enrolled patients with T2D and CKD stage 4. The BEACON trial was terminated after preliminary analyses showed that patients randomized to bardoxolone methyl experienced significantly higher rates of heart failure events. We performed post-hoc analyses to characterize changes in kidney function induced by bardoxolone methyl. Methods Patients in ­BEACON (n = 2,185) were randomized 1: 1 to receive once-daily bardoxolone methyl (20 mg) or placebo. We compared the effects of bardoxolone methyl and placebo on a post-hoc composite renal endpoint consisting of ≥30% decline from baseline in eGFR, eGFR <15 mL/min/1.73 m2, and end-stage renal disease (ESRD) events (provision of dialysis or kidney transplantation). Results Consistent with prior studies, patients randomized to bardoxolone methyl experienced mean increases in eGFR that were sustained through study week 48. Moreover, increases in eGFR from baseline were sustained 4 weeks after cessation of treatment. Patients randomized to bardoxolone methyl were significantly less likely to experience the composite renal endpoint (hazards ratio 0.48 [95% CI 0.36–0.64]; p < 0.0001). Conclusions Bardoxolone methyl preserves kidney function and may delay the onset of ESRD in patients with T2D and stage 4 CKD. PMID:29402767

Bardoxolone Methyl Improves Kidney Function in Patients with Chronic Kidney Disease Stage 4 and Type 2 Diabetes: Post-Hoc Analyses from Bardoxolone Methyl Evaluation in Patients with Chronic Kidney Disease and Type 2 Diabetes Study.

PubMed

Chin, Melanie P; Bakris, George L; Block, Geoffrey A; Chertow, Glenn M; Goldsberry, Angie; Inker, Lesley A; Heerspink, Hiddo J L; O'Grady, Megan; Pergola, Pablo E; Wanner, Christoph; Warnock, David G; Meyer, Colin J

2018-01-01

Increases in measured inulin clearance, measured creatinine clearance, and estimated glomerular filtration rate (eGFR) have been observed with bardoxolone methyl in 7 studies enrolling approximately 2,600 patients with type 2 diabetes (T2D) and chronic kidney disease (CKD). The largest of these studies was Bardoxolone Methyl Evaluation in Patients with Chronic Kidney Disease and Type 2 Diabetes (BEACON), a multinational, randomized, double-blind, placebo-controlled phase 3 trial which enrolled patients with T2D and CKD stage 4. The BEACON trial was terminated after preliminary analyses showed that patients randomized to bardoxolone methyl experienced significantly higher rates of heart failure events. We performed post-hoc analyses to characterize changes in kidney function induced by bardoxolone methyl. Patients in -BEACON (n = 2,185) were randomized 1: 1 to receive once-daily bardoxolone methyl (20 mg) or placebo. We compared the effects of bardoxolone methyl and placebo on a post-hoc composite renal endpoint consisting of ≥30% decline from baseline in eGFR, eGFR <15 mL/min/1.73 m2, and end-stage renal disease (ESRD) events (provision of dialysis or kidney transplantation). Consistent with prior studies, patients randomized to bardoxolone methyl experienced mean increases in eGFR that were sustained through study week 48. Moreover, increases in eGFR from baseline were sustained 4 weeks after cessation of treatment. Patients randomized to bardoxolone methyl were significantly less likely to experience the composite renal endpoint (hazards ratio 0.48 [95% CI 0.36-0.64]; p < 0.0001). Bardoxolone methyl preserves kidney function and may delay the onset of ESRD in patients with T2D and stage 4 CKD. © 2018 The Author(s) Published by S. Karger AG, Basel.

Risk factors of severity of abuse against older women in the home setting: A multinational European study.

PubMed

Donder, Liesbeth De; Lang, Gert; Ferreira-Alves, José; Penhale, Bridget; Tamutiene, Ilona; Luoma, Minna-Liisa

2016-01-01

This article examines the ecological risk factors of abuse against older women. Data from 2,880 older women were randomly collected in five European countries (Austria, Belgium, Finland, Lithuania, and Portugal) using a standardized questionnaire. Results indicate that overall 30.1 % older women had at least one experience of abuse in the past year. The findings demonstrate that a single emphasis on personal risk factors (e.g., health, coping) is important but too simple: Abuse is multifaceted and is embedded in environmental (e.g., loneliness, household income) as well as macrocultural contexts (e.g., old age dependency ratio).

Leadership styles of nurse managers in a multinational environment.

PubMed

Suliman, Wafika A

2009-01-01

This is a descriptive study conducted at a multinational working environment, where 1500 nurses representing 52 nationalities are employed. The study aimed at exploring the predominant leadership style of nurse managers through self-evaluation and staff nurses' evaluation and the impact of working in a multinational environment on their intention to stay or quit. The value lies in its focus on leadership styles in an environment where national diversity among managers, staff, and patients is very challenging. The study included 31 nurse managers and 118 staff nurses using Bass and Avolio's (1995) Multifactor Leadership Questionnaire. The results showed that nurse managers and staff nurses reported transformational leadership as predominant with significant difference in favor of nurse managers. Participants' nationality and intention to stay or quit affected their perception of transformational leadership as a predominant style. The implications highlight the need for senior nursing management to set effective retention strategies for transformational nurse managers who work at multinational environments.

Multinationals' Political Activities on Climate Change

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

Kolk, A.; Pinkse, J.

2007-06-15

This article explores the international dimensions of multinationals' corporate political activities, focusing on an international issue - climate change - being implemented differently in a range of countries. Analyzing data from Financial Times Global 500 firms, it examines the influence on types and process of multinationals' political strategies, reckoning with institutional contexts and issue saliency. Findings show that the type of political activities can be characterized as an information strategy to influence policy makers toward market-based solutions, not so much withholding action on emission reduction. Moreover, multinationals pursue self-regulation, targeting a broad range of political actors. The process of politicalmore » strategy is mostly one of collective action. International differences particularly surface in the type of political actors aimed at, with U.S. and Australian firms focusing more on non-government actors (voluntary programs) than European and Japanese firms. Influencing home-country (not host-country) governments is the main component of international political strategy on climate change.« less

Proliferation resistance design of a plutonium cycle (Proliferation Resistance Engineering Program: PREP)

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

Sorenson, R.J.; Roberts, F.P.; Clark, R.G.

1979-01-19

This document describes the proliferation resistance engineering concepts developed to counter the threat of proliferation of nuclear weapons in an International Fuel Service Center (IFSC). The basic elements of an International Fuel Service Center are described. Possible methods for resisting proliferation such as processing alternatives, close-coupling of facilities, process equipment layout, maintenance philosophy, process control, and process monitoring are discussed. Political and institutional issues in providing proliferation resistance for an International Fuel Service Center are analyzed. The conclusions drawn are (1) use-denial can provide time for international response in the event of a host nation takeover. Passive use-denial is moremore » acceptable than active use-denial, and acceptability of active-denial concepts is highly dependent on sovereignty, energy dependence and economic considerations; (2) multinational presence can enhance proliferation resistance; and (3) use-denial must be nonprejudicial with balanced interests for governments and/or private corporations being served. Comparisons between an IFSC as a national facility, an IFSC with minimum multinational effect, and an IFSC with maximum multinational effect show incremental design costs to be less than 2% of total cost of the baseline non-PRE concept facility. The total equipment acquisition cost increment is estimated to be less than 2% of total baseline facility costs. Personnel costs are estimated to increase by less than 10% due to maximum international presence. 46 figures, 9 tables.« less

“Lost in translation”: accounting for between-country differences in the analysis of multinational cost-effectiveness data§

PubMed Central

Manca, Andrea; Willan, Andrew R.

2008-01-01

Background Cost-effectiveness analysis has gained status over the last 15 years as an important tool for assisting resource allocation decisions in a budged-limited environment such as healthcare. Randomised (multicentre) multinational controlled trials are often the main vehicle to collect primary patient-level information on resource use, cost and clinical effectiveness associated with alternative treatment strategies. However, trial-wide cost-effectiveness results may not be directly applicable to any one of the countries that participate in a multinational trial, requiring some form of additional modelling to customise the results to the country of interest. Objective The aim is to produce recommendations regarding methods that can be (currently) considered ‘good practice’ when exploring the geographical generalisability of cost-effectiveness data. The manuscript proposes an algorithm to assist with the choice of the appropriate analytical strategy when facing the task of adapting the study results from one country to another. The algorithm considers different scenarios characterised by whether or not (a) the country of interest participated in the trial, and (b) individual patient-level data (IPD) from the trial are available. Methods Structured review with description and discussion of case studies. Conclusions Methods to reflect between-country variability in cost-effectiveness data are available. It is important to be transparent regarding the assumptions made in the analysis and (where possible) assess their impact on the study results. PMID:17067195

Process-based interpretation of conceptual hydrological model performance using a multinational catchment set

NASA Astrophysics Data System (ADS)

Poncelet, Carine; Merz, Ralf; Merz, Bruno; Parajka, Juraj; Oudin, Ludovic; Andréassian, Vazken; Perrin, Charles

2017-08-01

Most of previous assessments of hydrologic model performance are fragmented, based on small number of catchments, different methods or time periods and do not link the results to landscape or climate characteristics. This study uses large-sample hydrology to identify major catchment controls on daily runoff simulations. It is based on a conceptual lumped hydrological model (GR6J), a collection of 29 catchment characteristics, a multinational set of 1103 catchments located in Austria, France, and Germany and four runoff model efficiency criteria. Two analyses are conducted to assess how features and criteria are linked: (i) a one-dimensional analysis based on the Kruskal-Wallis test and (ii) a multidimensional analysis based on regression trees and investigating the interplay between features. The catchment features most affecting model performance are the flashiness of precipitation and streamflow (computed as the ratio of absolute day-to-day fluctuations by the total amount in a year), the seasonality of evaporation, the catchment area, and the catchment aridity. Nonflashy, nonseasonal, large, and nonarid catchments show the best performance for all the tested criteria. We argue that this higher performance is due to fewer nonlinear responses (higher correlation between precipitation and streamflow) and lower input and output variability for such catchments. Finally, we show that, compared to national sets, multinational sets increase results transferability because they explore a wider range of hydroclimatic conditions.

Preliminary results of the global audit of treatment of refractory status epilepticus.

PubMed

Ferlisi, M; Hocker, S; Grade, M; Trinka, E; Shorvon, S

2015-08-01

The treatment of refractory and super refractory status epilepticus is a "terra incognita" from the point of view of evidence-based medicine. As randomized or controlled studies that are sufficiently powered are not feasible in relation to the many therapies and treatment approaches available, we carried out an online multinational audit (registry) in which neurologists or intensivists caring for patients with status epilepticus may prospectively enter patients who required general anesthesia to control the status epilepticus (SE). To date, 488 cases from 44 different countries have been collected. Most of the patients had no history of epilepsy and had a cryptogenic etiology. First-line treatment was delayed and not in line with current guidelines. The most widely used anesthetic of first choice was midazolam (59%), followed by propofol and barbiturates. Ketamine was used in most severe cases. Other therapies were administered in 35% of the cases, mainly steroids and immunotherapy. Seizure control was achieved in 74% of the patients. Twenty-two percent of patients died during treatment, and four percent had treatment actively withdrawn because of an anticipated poor outcome. The neurological outcome was good in 36% and poor in 39.3% of cases, while 25% died during hospitalization. Factors that positively influenced outcome were younger age, history of epilepsy, and low number of different anesthetics tried. This article is part of a Special Issue entitled "Status Epilepticus". Copyright © 2015. Published by Elsevier Inc.

Patient perspectives in the management of psoriasis: results from the population-based Multinational Assessment of Psoriasis and Psoriatic Arthritis Survey.

PubMed

Lebwohl, Mark G; Bachelez, Hervé; Barker, Jonathan; Girolomoni, Giampiero; Kavanaugh, Arthur; Langley, Richard G; Paul, Carle F; Puig, Lluís; Reich, Kristian; van de Kerkhof, Peter C M

2014-05-01

Available psoriasis surveys offer valuable information about psoriasis and psoriatic arthritis (PsA), but are limited by methodology or enrollment requirements. To further the understanding of the unmet needs of psoriasis and PsA patients. This was a large, multinational, population-based survey of psoriasis and/or PsA patients in North America and Europe. Patients were selected by list-assisted random digit dialing and did not have to currently be under the care of a health care provider, a patient organization member, or receiving treatment; 139,948 households were screened and 3426 patients completed the survey. The prevalence of psoriasis/PsA ranged from 1.4% to 3.3%; 79% had psoriasis alone and 21% had PsA. When rating disease severity at its worst, 27% (psoriasis) and 53% (PsA ± psoriasis) of patients rated it as severe. Psoriasis patients indicated that their most bothersome signs or symptoms were itching (43%), scales (23%), and flaking (20%). Of psoriasis patients, 45% had not seen a physician in a year; >80% of psoriasis patients with ≥ 4 palms body surface area and 59% of PsA patients were receiving no treatment or topical treatment only. Of patients who had received oral or biologic therapy, 57% and 45%, respectively, discontinued therapy, most often for safety/tolerability reasons and a lack/loss of efficacy. The survey lacked a control group, did not account for ethnic and health care system differences across countries, and was limited by factors associated with any patient survey, including accurate recall and interpretation of questions. Several identified unmet needs warrant additional attention and action, including improved severity assessment, PsA screening, patient awareness, and treatment options. Copyright © 2014 American Academy of Dermatology, Inc. Published by Mosby, Inc. All rights reserved.

Business Communication Consulting and Research in Multinational Companies.

ERIC Educational Resources Information Center

Hildebrandt, Herbert W.

1978-01-01

Describes three issues involved in communication research and consulting for multinational companies, particularly those in Germany: qualifications for doing international consulting and research, problems of American scholar-researchers in those firms, and suggestions for dealing with those issues. (JMF)

Culture and International Management: A Review.

ERIC Educational Resources Information Center

Miroshnik, Victoria

2002-01-01

A literature review explored the effectiveness of cross-cultural managements of multinational companies. The effect of national culture on organizational culture was analyzed and ways in which multinational companies can adopt the national differences were suggested. (Contains 42 references.) (JOW)

Rotigotine Effects on Early Morning Motor Function and Sleep in Parkinson's Disease: A Double-Blind, Randomized, pLacebo-Controlled Study (RECOVER)

PubMed Central

Trenkwalder, Claudia; Kies, Bryan; Rudzinska, Monika; Fine, Jennifer; Nikl, Janos; Honczarenko, Krystyna; Dioszeghy, Peter; Hill, Dennis; Anderson, Tim; Myllyla, Vilho; Kassubek, Jan; Steiger, Malcolm; Zucconi, Marco; Tolosa, Eduardo; Poewe, Werner; Surmann, Erwin; Whitesides, John; Boroojerdi, Babak; Chaudhuri, Kallol Ray

2011-01-01

In a multinational, double-blind, placebo-controlled trial (NCT00474058), 287 subjects with Parkinson's disease (PD) and unsatisfactory early-morning motor symptom control were randomized 2:1 to receive rotigotine (2–16 mg/24 hr [n = 190]) or placebo (n = 97). Treatment was titrated to optimal dose over 1–8 weeks with subsequent dose maintenance for 4 weeks. Early-morning motor function and nocturnal sleep disturbance were assessed as coprimary efficacy endpoints using the Unified Parkinson's Disease Rating Scale (UPDRS) Part III (Motor Examination) measured in the early morning prior to any medication intake and the modified Parkinson's Disease Sleep Scale (PDSS-2) (mean change from baseline to end of maintenance [EOM], last observation carried forward). At EOM, mean UPDRS Part III score had decreased by −7.0 points with rotigotine (from a baseline of 29.6 [standard deviation (SD) 12.3] and by −3.9 points with placebo (baseline 32.0 [13.3]). Mean PDSS-2 total score had decreased by −5.9 points with rotigotine (from a baseline of 19.3 [SD 9.3]) and by −1.9 points with placebo (baseline 20.5 [10.4]). This represented a significantly greater improvement with rotigotine compared with placebo on both the UPDRS Part III (treatment difference: −3.55 [95% confidence interval (CI) −5.37, −1.73]; P = 0.0002) and PDSS-2 (treatment difference: −4.26 [95% CI −6.08, −2.45]; P < 0.0001). The most frequently reported adverse events were nausea (placebo, 9%; rotigotine, 21%), application site reactions (placebo, 4%; rotigotine, 15%), and dizziness (placebo, 6%; rotigotine 10%). Twenty-four-hour transdermal delivery of rotigotine to PD patients with early-morning motor dysfunction resulted in significant benefits in control of both motor function and nocturnal sleep disturbances. © 2010 Movement Disorder Society PMID:21322021

Risk factors for acute generalized exanthematous pustulosis (AGEP)-results of a multinational case-control study (EuroSCAR).

PubMed

Sidoroff, A; Dunant, A; Viboud, C; Halevy, S; Bavinck, J N Bouwes; Naldi, L; Mockenhaupt, M; Fagot, J-P; Roujeau, J-C

2007-11-01

Acute generalized exanthematous pustulosis (AGEP) is a disease characterized by the rapid occurrence of many sterile, nonfollicular pustules usually arising on an oedematous erythema often accompanied by leucocytosis and fever. It is usually attributed to drugs. To evaluate the risk for different drugs of causing AGEP. A multinational case-control study (EuroSCAR) conducted to evaluate the risk for different drugs of causing severe cutaneous adverse reactions; the study included 97 validated community cases of AGEP and 1009 controls. Results Strongly associated drugs, i.e. drugs with a lower bound of the 95% confidence interval (CI) of the odds ratio (OR) > 5 were pristinamycin (CI 26-infinity), ampicillin/amoxicillin (CI 10-infinity), quinolones (CI 8.5-infinity), (hydroxy)chloroquine (CI 8-infinity), anti-infective sulphonamides (CI 7.1-infinity), terbinafine (CI 7.1-infinity) and diltiazem (CI 5.0-infinity). No significant risk was found for infections and a personal or family history of psoriasis (CI 0.7-2.2). Medications associated with AGEP differ from those associated with Stevens-Johnson syndrome or toxic epidermal necrolysis. Different timing patterns from drug intake to reaction onset were observed for different drugs. Infections, although possible triggers, played no prominent role in causing AGEP and there was no evidence that AGEP is a variant of pustular psoriasis.

Five Themes Impacting Collaboration in a Joint Interagency Multinational Public Operational Context (Les cinq Facteurs Influencant la Collaboration en Contexte Operationnel Interarmees, Interorganisationnel, Multinational et Public)

DTIC Science & Technology

2011-03-01

cited by the Director of Land Concepts and Designs as an important enabler for the Army of Tomorrow operating concept of adaptive dispersed operations...2010). La partie 1.3 porte sur l’influence du pouvoir sur la collaboration. Étant donné l’ampleur des FC comparativement à celle de la plupart des...Multinational Public (JIMP) operating environment, the capacity to be "JIMP-capable" is now cited by the Director of Land Concepts and Designs as an important

CRM System Implementation in a Multinational Enterprise

NASA Astrophysics Data System (ADS)

Mishra, Alok; Mishra, Deepti

The concept of customer relationship management (CRM) resonates with managers in today's competitive economy. As more and more organizations realize the significance of becoming customer-centric in today's competitive era, they embrace CRM as a core business strategy. CRM an integration of information technology and relationship marketing provides the infrastructure that facilitates long-term relationship building with customers at an enterprise-wide level. Successful CRM implementation is a complex, expensive and rarely technical projects. This paper presents the successful implementation of CRM in a multinational organization. This study will facilitate in understanding transition, constraints and implementation of CRM in multinational enterprises.

Economic Evaluation alongside Multinational Studies: A Systematic Review of Empirical Studies

PubMed Central

Oppong, Raymond; Jowett, Sue; Roberts, Tracy E.

2015-01-01

Purpose of the study This study seeks to explore methods for conducting economic evaluations alongside multinational trials by conducting a systematic review of the methods used in practice and the challenges that are typically faced by the researchers who conducted the economic evaluations. Methods A review was conducted for the period 2002 to 2012, with potentially relevant articles identified by searching the Medline, Embase and NHS EED databases. Studies were included if they were full economic evaluations conducted alongside a multinational trial. Results A total of 44 studies out of a possible 2667 met the inclusion criteria. Methods used for the analyses varied between studies, indicating a lack of consensus on how economic evaluation alongside multinational studies should be carried out. The most common challenge appeared to be related to addressing differences between countries, which potentially hinders the generalisability and transferability of results. Other challenges reported included inadequate sample sizes and choosing cost-effectiveness thresholds. Conclusions It is recommended that additional guidelines be developed to aid researchers in this area and that these be based on an understanding of the challenges associated with multinational trials and the strengths and limitations of alternative approaches. Guidelines should focus on ensuring that results will aid decision makers in their individual countries. PMID:26121465

Multinational Quality Assurance

ERIC Educational Resources Information Center

Kinser, Kevin

2011-01-01

Multinational colleges and universities pose numerous challenges to the traditional models of quality assurance that are designed to validate domestic higher education. When institutions cross international borders, at least two quality assurance protocols are involved. To guard against fraud and abuse, quality assurance in the host country is…

Communication Effectiveness in Multinational Organizations: Developing Universal Intercultural Skills.

ERIC Educational Resources Information Center

Baird, John W.; Stull, James B.

The increase in size and number of multinational corporations requires programs for training their personnel in intercultural communication emphasizing development of skills necessary for cultural adaptation and a "universal" perspective. Currently, intercultural training is either nonexistent or emphasizes mastery of language with…

Multinational Activities of Major U.S. Automotive Producers : Volume 2. Data on Foreign Facilities and Operations.

DOT National Transportation Integrated Search

1978-09-01

The objective of Volume II is to present data gathered from several sources, public and private, on three aspects of multinational involvement for General Motors Corporation, Ford Motor Company, Chrysler Corporation, and American Motors Corporation. ...

A Medical Student-Delivered Smoking Prevention Program, Education Against Tobacco, for Secondary Schools in Germany: Randomized Controlled Trial

PubMed Central

Owczarek, Andreas Dawid; Seeger, Werner; Groneberg, David Alexander; Brieske, Christian Martin; Jansen, Philipp; Klode, Joachim; Stoffels, Ingo; Schadendorf, Dirk; Izar, Benjamin; Fries, Fabian Norbert; Hofmann, Felix Johannes

2017-01-01

Background More than 8.5 million Germans suffer from chronic diseases attributable to smoking. Education Against Tobacco (EAT) is a multinational network of medical students who volunteer for school-based prevention in the classroom setting, amongst other activities. EAT has been implemented in 28 medical schools in Germany and is present in 13 additional countries around the globe. A recent quasi-experimental study showed significant short-term smoking cessation effects on 11-to-15-year-old adolescents. Objective The aim of this study was to provide the first randomized long-term evaluation of the optimized 2014 EAT curriculum involving a photoaging software for its effectiveness in reducing the smoking prevalence among 11-to-15-year-old pupils in German secondary schools. Methods A randomized controlled trial was undertaken with 1504 adolescents from 9 German secondary schools, aged 11-15 years in grades 6-8, of which 718 (47.74%) were identifiable for the prospective sample at the 12-month follow-up. The experimental study design included measurements at baseline (t1), 6 months (t2), and 12 months postintervention (t3), via questionnaire. The study groups consisted of 40 randomized classes that received the standardized EAT intervention (two medical student-led interactive modules taking 120 minutes total) and 34 control classes within the same schools (no intervention). The primary endpoint was the difference in smoking prevalence from t1 to t3 in the control group versus the difference from t1 to t3 in the intervention group. The differences in smoking behavior (smoking onset, quitting) between the two groups, as well as gender-specific effects, were studied as secondary outcomes. Results None of the effects were significant due to a high loss-to-follow-up effect (52.26%, 786/1504). From baseline to the two follow-up time points, the prevalence of smoking increased from 3.1% to 5.2% to 7.2% in the control group and from 3.0% to 5.4% to 5.8% in the intervention group (number needed to treat [NNT]=68). Notable differences were observed between the groups for the female gender (4.2% to 9.5% for control vs 4.0% to 5.2% for intervention; NNT=24 for females vs NNT=207 for males), low educational background (7.3% to 12% for control vs 6.1% to 8.7% for intervention; NNT=30), and migrational background (students who claimed that at least one parent was not born in Germany) at the 12-month follow-up. The intervention appears to prevent smoking onset (NNT=63) but does not appear to initiate quitting. Conclusions The intervention appears to prevent smoking, especially in females and students with a low educational background. PMID:28588007

Advanced fighter technology integration (AFTI)/F-16 Automated Maneuvering Attack System final flight test results

NASA Technical Reports Server (NTRS)

Dowden, Donald J.; Bessette, Denis E.

1987-01-01

The AFTI F-16 Automated Maneuvering Attack System has undergone developmental and demonstration flight testing over a total of 347.3 flying hours in 237 sorties. The emphasis of this phase of the flight test program was on the development of automated guidance and control systems for air-to-air and air-to-ground weapons delivery, using a digital flight control system, dual avionics multiplex buses, an advanced FLIR sensor with laser ranger, integrated flight/fire-control software, advanced cockpit display and controls, and modified core Multinational Stage Improvement Program avionics.

Association Between Peritoneal Glucose Exposure and Peritonitis in Peritoneal Dialysis Patients: The balANZ Trial.

PubMed

Nataatmadja, Melissa; Cho, Yeoungjee; Pascoe, Elaine M; Darssan, Darsy; Hawley, Carmel M; Johnson, David W

2017-01-01

Glucose is the primary osmotic medium used in most peritoneal dialysis (PD) solutions, and exposure to glucose has been shown to exert detrimental effects both locally, at the peritoneal membrane, and systemically. Moreover, high dialysate glucose exposure may predispose patients to an increased risk of peritonitis, perhaps as a result of impaired host defences, vascular disease, and damage to the peritoneal membrane. In this post-hoc analysis of a multicenter, multinational, open-label randomized controlled trial of neutral pH, low-glucose degradation product (GDP) versus conventional PD solutions ( bal ANZ trial), the relationship between peritonitis rates of low (< 123.1 g/day) versus high (≥ 123.1 g/day) dialysate glucose exposure was evaluated in 177 incident PD patients over a 2-year study period. Peritonitis rates were 0.44 episodes per patient-year in the low-glucose exposure group and 0.31 episodes per patient-year in the high-glucose exposure group, (incidence rate ratio [IRR] 0.69, p = 0.09). There was no significant association between dialysate glucose exposure and peritonitis-free survival on univariable analysis (high glucose exposure hazard ratio [HR] 0.66, 95% confidence interval [CI] 0.40 - 1.08) or on multivariable analysis (adjusted HR 0.64, 95% CI 0.39 - 1.05). Moreover, there was no relationship between peritoneal glucose exposure and type of organism causing peritonitis. Physician-rated severity of first peritonitis episodes was similar between groups, as was rate and duration of hospital admission. Overall, this study did not identify an association between peritoneal dialysate glucose exposure and peritonitis occurrence, severity, hospitalization, or outcomes. A further large-scale, prospective, randomized controlled trial evaluating patient-level outcomes is merited. Copyright © 2017 International Society for Peritoneal Dialysis.

Small Nations in Multinational Operations and Armenian Perspectives

DTIC Science & Technology

2014-12-12

National Security Powers: Are the Checks in Balance?” In U.S. Army War College Guide to National Security Issues, Volume II: National Security Policy and...SMALL NATIONS IN MULTINATIONAL OPERATIONS AND ARMENIAN PERSPECTIVES A thesis presented to the Faculty of the U.S. Army

The Role of Training and Skilled Labour in the Success of SMEs in Developing Economies

ERIC Educational Resources Information Center

Robertson, Paul L.

2003-01-01

The ability of small and medium-sized enterprises in developing nations to evolve technologically is frequently constrained by a variety of environmental factors that are beyond their control. In many cases, it is necessary for the strategy of SMEs to be aligned with the international supply chain strategies of multinational firms, who can provide…

Command and Control for Joint Air Operations.

DTIC Science & Technology

1994-11-14

publication apply to the throughout the range of military commanders of combatant commands, operations. subunified commands, joint task forces, and...this doctrine (or operations as well as the doctrinal basis JTTP) will be followed except when, in for US military involvement in the judgment of the...commander, multinational and interagency operations. exceptional circumstances dictate It provides military guidance for the otherwise. If conflicts

Multinationals, state-owned corporations, and the transformation of imperialism: a Brazilian case study

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

Evans, P.

1977-10-01

The Brazilian petrochemical industry is used as a case study in cooperation of state-owned and multinational corporations in bringing capitalism into the Third World. The petrochemical industry was chosen because it entails enormous transfers of capital investment and technology and the development of internal industrialization. Active participation by the host state, while it modifies the capitalization process, also is seen to provide a mutually beneficial partnership. A chronological account is given of the process by which Brazil evolved a system for encouraging multinationals to bring basic industries while participating directly in production. Multinationals have found that state-owned corporations do notmore » destroy capitalism, while the state-owned corporations have adapted to a profit orientation. A new ruling class has emerged in the process to provide technical and managerial skills. A disappointing social record developed at the same time and indicates the capitalization process was not able to provide the expected social benefits. (DCK)« less

Breast-feeding: the role of multinational corporations in Latin America.

PubMed

Bader, M B

1976-01-01

The decline in birthrates in the developed countries of the world has forced multinational corporations engaged in the production of infant formula to seek out new markets in the developing countries, where burgeoning population rates potentially guarantee the long-term profitability of these corporations. This development, ostensibly benign and nutritionally advantageous to infants in developing countries, has serious public health consequences, due to the high relative cost of purchased formula and the paucity of hygienic facilities essential to the sterile preparation of bottle formula. This paper delineates in detail economic and contraceptive advantages of breast-feeding, and examines the role of health personnel and multinational advertising techniques which have catalyzed the decline in breast-feeding. In addition, the paper focuses on the question of cultural imperialism and current efforts to regulate the multinational firms through both United Nations groups and stock-holders' suits. Finally, some suggestions are made concerning ameliorative public policy approaches to the breast-feeding controversy.

A phase II randomized clinical trial on cerebral near-infrared spectroscopy plus a treatment guideline versus treatment as usual for extremely preterm infants during the first three days of life (SafeBoosC): study protocol for a randomized controlled trial

PubMed Central

2013-01-01

Background Every year in Europe about 25,000 infants are born extremely preterm. These infants have a 20% mortality rate, and 25% of survivors have severe long-term cerebral impairment. Preventative measures are key to reduce mortality and morbidity in an extremely preterm population. The primary objective of the SafeBoosC phase II trial is to examine if it is possible to stabilize the cerebral oxygenation of extremely preterm infants during the first 72 hours of life through the application of cerebral near-infrared spectroscopy (NIRS) oximetry and implementation of an clinical treatment guideline based on intervention thresholds of cerebral regional tissue saturation rStO2. Methods/Design SafeBoosC is a randomized, blinded, multinational, phase II clinical trial. The inclusion criteria are: neonates born more than 12 weeks preterm; decision to conduct full life support; parental informed consent; and possibility to place the cerebral NIRS oximeter within 3 hours after birth. The infants will be randomized into one of two groups. Both groups will have a cerebral oximeter monitoring device placed within three hours of birth. In the experimental group, the cerebral oxygenation reading will supplement the standard treatment using a predefined treatment guideline. In the control group, the cerebral oxygenation reading will not be visible and the infant will be treated according to the local standards. The primary outcome is the multiplication of the duration and magnitude of rStO2 values outside the target ranges of 55% to 85%, that is, the ‘burden of hypoxia and hyperoxia’ expressed in ‘%hours’. To detect a 50% difference between the experimental and control group in %hours, 166 infants in total must be randomized. Secondary outcomes are mortality at term date, cerebral ultrasound score, and interburst intervals on an amplitude-integrated electroencephalogram at 64 hours of life and explorative outcomes include neurodevelopmental outcome at 2 years corrected age, magnetic resonance imaging at term, blood biomarkers at 6 and 64 hours after birth, and adverse events. Discussion Cerebral oximetry guided interventions have the potential to improve neurodevelopmental outcome in extremely preterm infants. It is a logical first step to test if it is possible to reduce the burden of hypoxia and hyperoxia. Trial registration ClinicalTrial.gov, NCT01590316 PMID:23782447

Fixation using alternative implants for the treatment of hip fractures (FAITH): design and rationale for a multi-centre randomized trial comparing sliding hip screws and cancellous screws on revision surgery rates and quality of life in the treatment of femoral neck fractures.

PubMed

2014-06-26

Hip fractures are a common type of fragility fracture that afflict 293,000 Americans (over 5,000 per week) and 35,000 Canadians (over 670 per week) annually. Despite the large population impact the optimal fixation technique for low energy femoral neck fractures remains controversial. The primary objective of the FAITH study is to assess the impact of cancellous screw fixation versus sliding hip screws on rates of revision surgery at 24 months in individuals with femoral neck fractures. The secondary objective is to determine the impact on health-related quality of life, functional outcomes, health state utilities, fracture healing, mortality and fracture-related adverse events. FAITH is a multi-centre, multi-national randomized controlled trial utilizing minimization to determine patient allocation. Surgeons in North America, Europe, Australia, and Asia will recruit a total of at least 1,000 patients with low-energy femoral neck fractures. Using central randomization, patients will be allocated to receive surgical treatment with cancellous screws or a sliding hip screw. Patient outcomes will be assessed at one week (baseline), 10 weeks, 6, 12, 18, and 24 months post initial fixation. We will independently adjudicate revision surgery and complications within 24 months of the initial fixation. Outcome analysis will be performed using a Cox proportional hazards model and likelihood ratio test. This study represents major international efforts to definitively resolve the treatment of low-energy femoral neck fractures. This trial will not only change current Orthopaedic practice, but will also set a benchmark for the conduct of future Orthopaedic trials. The FAITH trial is registered at ClinicalTrials.gov (Identifier NCT00761813).

A randomized, placebo‐controlled trial of cenicriviroc for treatment of nonalcoholic steatohepatitis with fibrosis

PubMed Central

Ratziu, Vlad; Harrison, Stephen A.; Abdelmalek, Manal F.; Aithal, Guruprasad P.; Caballeria, Juan; Francque, Sven; Farrell, Geoffrey; Kowdley, Kris V.; Craxi, Antonio; Simon, Krzysztof; Fischer, Laurent; Melchor‐Khan, Liza; Vest, Jeffrey; Wiens, Brian L.; Vig, Pamela; Seyedkazemi, Star; Goodman, Zachary; Wong, Vincent Wai‐Sun; Loomba, Rohit; Tacke, Frank; Sanyal, Arun; Lefebvre, Eric

2018-01-01

The aim of this study was to evaluate cenicriviroc (CVC), a dual antagonist of C—C chemokine receptor types 2 and 5, for treatment of nonalcoholic steatohepatitis (NASH) with liver fibrosis (LF). A randomized, double‐blind, multinational phase 2b study enrolled subjects with NASH, a nonalcoholic fatty liver disease activity score (NAS) ≥4, and LF (stages 1‐3, NASH Clinical Research Network) at 81 clinical sites. Subjects (N = 289) were randomly assigned CVC 150 mg or placebo. Primary outcome was ≥2‐point improvement in NAS and no worsening of fibrosis at year 1. Key secondary outcomes were: resolution of steatohepatitis (SH) and no worsening of fibrosis; improvement in fibrosis by ≥1 stage and no worsening of SH. Biomarkers of inflammation and adverse events were assessed. Full study recruitment was achieved. The primary endpoint of NAS improvement in the intent‐to‐treat population and resolution of SH was achieved in a similar proportion of subjects on CVC (N = 145) and placebo (N = 144; 16% vs. 19%, P = 0.52 and 8% vs. 6%, P = 0.49, respectively). However, the fibrosis endpoint was met in significantly more subjects on CVC than placebo (20% vs. 10%; P = 0.02). Treatment benefits were greater in those with higher disease activity and fibrosis stage at baseline. Biomarkers of systemic inflammation were reduced with CVC. Safety and tolerability of CVC were comparable to placebo. Conclusion: After 1 year of CVC treatment, twice as many subjects achieved improvement in fibrosis and no worsening of SH compared with placebo. Given the urgent need to develop antifibrotic therapies in NASH, these findings warrant phase 3 evaluation. (Hepatology 2018;67:1754‐1767). PMID:28833331

Using Internet Resources in Teaching Financial Reporting and Analysis of Multinational Enterprises.

ERIC Educational Resources Information Center

Agami, Abdel M.

2003-01-01

Provides some sources of corporate financial information on the Internet and illustrates how to use these resources in teaching international business and, more specifically, financial reporting and analysis of multinational enterprises. Points out some of the advantages and limitations of these resources. (EV)

Current Status of Diversity Initiatives in Selected Multinational Corporations.

ERIC Educational Resources Information Center

Wentling, Rose Mary; Palma-Rivas, Nilda

2000-01-01

Interviews with eight diversity managers in multinational corporations revealed a variety of domestic and international diversity initiatives, especially in leadership and management. Formal and informal methods were used to plan them. Business unit managers were responsible for implementation. Evaluation was difficult and time consuming. (SK)

Intercultural Communication Problems in Japanese Multinationals.

ERIC Educational Resources Information Center

Nishiyama, Kazuo

Many large Japanese-owned multinational corporations have established successful subsidiaries in the United States, but distinct ethnic and cultural differences have caused communication problems between Japanese managers and American laborers and business people. Many top executives of the Japanese subsidiaries are sent to the United States on a…

Koinonia: The Requirements and Vision for an Unclassified Information-Sharing System

DTIC Science & Technology

2013-06-01

of an effort to share information with multinational partners in Multinational Planning Augmentation Team (MPAT) ( Tempest Express Fact Sheet 2011... Tempest fact sheet. Global Security.org. May 7, 2011. Accessed May 3, 2013. http://www.globalsecurity.org/military/ops/ tempest -express.htm U.S

Leadership challenges in multinational medical peacekeeping operations: Lessons from UNIFIL Hospital.

PubMed

Datta, Rakesh; Khanna, Sangeeta

2017-10-01

Commanding a military multinational and multilingual healthcare facility can be a formidable task with very little margin for error. The authors were in leadership positions of UNIFIL Hospital, unique in its diversity of both staff and clientele. Experience about the challenges faced and methods adopted to overcome them will be shared. Troops from diverse backgrounds differ in their competency, and also in their attitudinal approach to situations. It is imperative for the medical commanders to identify these differences, and work towards harnessing individual strengths to form a cohesive unit. Frequent rotation of team members and thereby difficulty in adapting to new environment makes the tasks more challenging. Challenges can be broadly categorized in those dealing with functional roles (providing medical support) and command and control issues. Linguistic challenges especially in situations where professionals have to work as a coordinated unit remains a major challenge. The threat of medical errors arising out of misunderstandings is very real. Gender sensitization is essential to avoid potential unpleasant situations. Interpersonal conflict can easily go out of hand. The leadership has to be more direct and deliberate relying less on hierarchy and more on direct communication. A strict enforcement of UN standards for equipment and competence, frequent joint medical drills help to overcome interoperability issues and develop mutual confidence. Leadership in multinational UN hospitals is a demanding task with its peculiar set of challenges. A systematic and deliberate approach focused on mutual respect, flexibility and direct leadership can help medical commanders in such situations.

Patients' perspectives in the management of psoriasis: the Italian results of the Multinational Assessment of Psoriasis and Psoriatic Arthritis (MAPP) survey.

PubMed

Gisondi, Paolo; Girolomoni, Giampiero

2017-08-01

The perspective of patients with psoriasis about medical care treatment goals and strategies is receiving increasing attention. Here, we performed a country-based analysis of the Multinational Assessment of Psoriasis and Psoriatic Arthritis (MAPP) survey, in order to provide specific information on patients' perspective of treatment of psoriasis in Italy. This was a systematic household telephone survey recruiting subjects by random digit dialing. Household members ≥18 years were included if they had ever been diagnosed with psoriasis. About 12,785 households were screened in Italy. 132 patients were ineligible for the analysis, including patients with psoriatic arthritis. 359 patients were surveyed. About half of the patients had very mild disease with less than 1 palm skin involvement, and 38% had 1-10 palm skin disease. It is noteworthy that 48% of patients with widespread disease were not taking any medication. Patients indicated the relief of symptoms, including itching (54.9%), as the main goal for their current therapy, whereas 14.2% reported no specific expectation from their medication. Overall, 70% of patients declared to be satisfied by their therapy, in terms of primary goal reached. Our findings suggest that most psoriasis patients have mild/moderate disease in Italy, and that a portion of patients with severe disease does not receive an adequate treatment.

Quality of life in relation to tamoxifen or exemestane treatment in postmenopausal breast cancer patients: a Tamoxifen Exemestane Adjuvant Multinational (TEAM) Trial side study.

PubMed

van Nes, J G H; Fontein, D B Y; Hille, E T M; Voskuil, D W; van Leeuwen, F E; de Haes, J C J M; Putter, H; Seynaeve, C; Nortier, J W R; van de Velde, C J H

2012-07-01

Tamoxifen and aromatase inhibitors are associated with side effects which can significantly impact quality of life (QoL). We assessed QoL in the Tamoxifen Exemestane Adjuvant Multinational (TEAM) Trial and compared these data with reported adverse events in the main database. 2,754 Dutch postmenopausal early breast cancer patients were randomized between 5 years of exemestane, or tamoxifen (2.5-3 years) followed by exemestane (2.5-2 years). 742 patients were invited to participate in the QoL side study and complete questionnaires at 1 (T1) and 2 (T2) years after start of endocrine treatment. Questionnaires comprised the EORTC QLQ-C30 and BR23 questionnaires, supplemented with FACT-ES questions. 543 patients completed questionnaires at T1 and 454 patients (84%) at T2. Overall QoL and most functioning scales improved over time. The only clinically relevant and statistically significant difference between treatment types concerned insomnia; exemestane-treated patients reported more insomnia than tamoxifen-treated patients. Discrepancy was observed between QoL issue scores reported by the patients and adverse events reported by physicians. Certain QoL issues are treatment- and/or time-specific and deserve attention by health care providers. There is a need for careful inquiry into QoL issues by those prescribing endocrine treatment to optimize QoL and treatment adherence.

Staffing UK University Campuses Overseas: Lessons from MNE Practice

ERIC Educational Resources Information Center

Salt, John; Wood, Peter

2014-01-01

This article suggests that as their internal labor markets become more multinational in scope, UK universities may acquire similar staffing characteristics to commercial multinational enterprises (MNEs). Comparing evidence from four UK universities with several surveys of MNEs it concludes that, although there are broad similarities in the…

Multinational Activities of Major U.S. Automotive Producers : Volume 5. Diffusion of Production and Sales Operations Abroad.

DOT National Transportation Integrated Search

1978-09-01

This is Volume V on the multi-national activities of the major U.S. automotive producers. The purpose of this Volume is to evaluate the foreign manufacturing and sales activities of the General Motors Corporation, Ford Motor Company, and Chrysler Cor...

The Role of Language in National and Multinational Enterprises in Taiwan.

ERIC Educational Resources Information Center

Du-Babcock, Bertha; Babcock, Richard D.

Communication patterns and language use in four national and multinational companies operating in Taiwan illustrate the potential for communication problems when more than one language is in use. The companies include Texas Instruments, Kaohsiung Monomer Company, Ltd., Bank of America, and Cheng-Yia International Corporation. In the four…

Evaluating Organizational Change at a Multinational Transportation Corporation: Method and Reflections

ERIC Educational Resources Information Center

Plakhotnik, Maria S.

2016-01-01

The purpose of this perspective on practice is to share my experience conducting an organizational change evaluation using qualitative methodology at a multinational transportation company Global Logistics. I provide a detailed description of the three phase approach to data analysis and my reflections on the process.

An Assessment of E-Training Effectiveness in Multinational Companies in Malaysia

ERIC Educational Resources Information Center

Ramayah, Thurasamy; Ahmad, Noor Hazlina; Hong, Tan Say

2012-01-01

E-training has developed into a revolutionary way of learning in Malaysian organizations due to rapid growth in information technology infrastructure. The present study endeavors to determine the critical factors that influence e-training effectiveness in multinational companies (MNCs) in Malaysia. By integrating Technology Acceptance Model (TAM),…

The Role of Culture on Knowledge Transfer: The Case of the Multinational Corporation

ERIC Educational Resources Information Center

Lucas, Leyland M.

2006-01-01

Purpose: This paper aims to look at the issue of culture's role in knowledge transfer within multinational corporations (MNCs). Studies of MNCs have hinted at the importance of culture to the performance of subsidiaries. Using Hofstede's cultural dimensions of power distance, individualism/collectivism, uncertainty avoidance, and…

GLOBAL CHANGE RESEARCH NEWS #10: MULTIAGENCY, MULTINATIONAL GLOBAL CHANGE RESEARCH EFFORT IN THE UPPER SAN PEDRO BASIN

EPA Science Inventory

This edition reports on a multiagency, multinational global-change research effort that seeks to evaluate the consequences of natural and human-induced changes in semi-arid environments. The Semi-Arid Land-Surface-Atmosphere Program ("SALSA") is focused on the environmentally sen...

Standardized Evaluation for Multi-National Development Programs.

ERIC Educational Resources Information Center

Farrell, W. Timothy

This paper takes the position that standardized evaluation formats and procedures for multi-national development programs are not only desirable but possible in diverse settings. The key is the localization of standard systems, which involves not only the technical manipulation of items and scales, but also the contextual interpretation of…

A Content Analysis of Multinationals' Web Communication Strategies: Cross-Cultural Research Framework and Pre-Testing.

ERIC Educational Resources Information Center

Okazaki, Shintaro; Alonso Rivas, Javier

2002-01-01

Discussion of research methodology for evaluating the degree of standardization in multinational corporations' online communication strategies across differing cultures focuses on a research framework for cross-cultural comparison of corporate Web pages, applying traditional advertising content study techniques. Describes pre-tests that examined…

Multinational Scanning: A Study of the Information Sources Utilized by Headquarters Executives in Multinational Companies

ERIC Educational Resources Information Center

Keegan, Warren J.

1974-01-01

Findings reveal the great importance of human sources of information and sources outside the organization. Divisional boundaries, functional specialization, and level were all found to act as significant barriers to information flows, and thus as limitations to organizational effectiveness. (Author/WM)

The Management of Training in Multinational Corporations: Comparative Case Studies.

ERIC Educational Resources Information Center

Noble, Charles

1997-01-01

Case studies of British and Australian multinational corporations in the food and drink industry investigated how training and development are managed. Competency-based education and industry boards are important elements in both countries. Lack of a training culture in the industry and little innovation in training were observed. (SK)

A Comparative Perspective of Intercultural Sensitivity between College Students and Multinational Employees in China

ERIC Educational Resources Information Center

Peng, Shi-Yong

2006-01-01

Using the Intercultural Sensitivity Scale formulated by G. M. Chen and Starosta, the intercultural sensitivity of English major students, non-English major students, and multinational employees in China were investigated. In this study, intercultural sensitivity was defined as consisting of interaction engagement, interaction confidence, respect…

Managing Human Resources in a Multinational Context

ERIC Educational Resources Information Center

Sumetzberger, Walter

2005-01-01

Purpose: To develop more sensitivity for different patterns of human resource management in multinational companies. Design/methodology/approach: Systemic approach; the concepts and models are based on the evaluation of consulting projects in the field of human resource management. Findings: A concept of four typical varieties of human resource…

Intraorganizational Career Advancement and Voluntary Turnover in a Multinational Bank in Taiwan

ERIC Educational Resources Information Center

Zhao, Wei; Zhou, Xueguang

2008-01-01

Purpose: This study aims to investigate how various aspects of intraorganizational career advancement--current career attainments, recent pace of upward mobility, and future prospect of career advancement--affect voluntary turnover, drawing empirical evidence from a multinational corporation (MNC) in Taiwan's cultural and labor market environment.…

The Contribution of Command and Control to Unity of Effort

DTIC Science & Technology

2002-09-01

Engineering and Evaluation Centre University of South Australia Mawson Lakes, South Australia Author contact: 6 Frank Street St Morris SA 5068... Mawson Lakes, South Australia, , 8. PERFORMING ORGANIZATION REPORT NUMBER 9. SPONSORING/MONITORING AGENCY NAME(S) AND ADDRESS(ES) 10. SPONSOR/MONITOR’S...Noel Sproles PhD Systems Engineering and Evaluation Centre University of South Australia Mawson Lakes, South Australia While joint and multi-national

A novel and selective sodium-glucose cotransporter-2 inhibitor, tofogliflozin, improves glycaemic control and lowers body weight in patients with type 2 diabetes mellitus.

PubMed

Ikeda, S; Takano, Y; Cynshi, O; Tanaka, R; Christ, A D; Boerlin, V; Beyer, U; Beck, A; Ciorciaro, C; Meyer, M; Kadowaki, T

2015-10-01

To assess the efficacy, safety and tolerability of different doses of tofogliflozin, a novel, highly selective sodium-glucose cotransporter 2 (SGLT2) inhibitor, in patients with type 2 diabetes mellitus (T2DM). In a 12-week, multicentre, multinational, randomized, double-blind, parallel-group, placebo-controlled, dose-finding study, patients with inadequate glycaemic control from diet and exercise alone, or from diet and exercise plus a stable dose of metformin, were randomized to one of five doses of tofogliflozin (2.5, 5, 10, 20, or 40 mg) or placebo. The primary efficacy endpoint was absolute change at week 12 from baseline in glycated haemoglobin (HbA1c), minus the change in the placebo group. Statistically significant dose-dependent reductions in HbA1c were shown in all treated groups except the 2.5-mg dose group, with a maximum reduction of 0.56% (placebo-subtracted) at the 40-mg dose, along with increased urinary glucose excretion. Metformin treatment had no substantial influence on tofogliflozin efficacy. Dose-dependent reductions in fasting plasma glucose and body weight were observed, and glucose intolerance was improved, with a trend towards blood pressure reduction. Slight increases were observed for mean ketone bodies with no abnormal change in ketone body ratio. No deaths or treatment-related serious adverse events were reported. The incidence of adverse events was similar in the placebo (37.9%) to that in the tofogliflozin group (35.9-46.3%). Withdrawal because of adverse events was rare (≤2 patients per treatment group), with similar rates of withdrawal in the placebo and tofogliflozin groups. A once-daily dose of tofogliflozin for 12 weeks was an effective, safe and well-tolerated treatment for T2DM. © 2015 John Wiley & Sons Ltd.

Photoaging smartphone app promoting poster campaign to reduce smoking prevalence in secondary schools: the Smokerface Randomized Trial: design and baseline characteristics.

PubMed

Brinker, Titus J; Holzapfel, Julia; Baudson, Tanja G; Sies, Katharina; Jakob, Lena; Baumert, Hannah Maria; Heckl, Marlene; Cirac, Ana; Suhre, Janina L; Mathes, Verena; Fries, Fabian N; Spielmann, Hannah; Rigotti, Nancy; Seeger, Werner; Herth, Felix; Groneberg, David A; Raupach, Tobias; Gall, Henning; Bauer, Claudia; Marek, Pat; Batra, Anil; Harrison, Chase H; Taha, Lava; Owczarek, Andreas; Hofmann, Felix J; Thomas, Roger; Mons, Ute; Kreuter, Michael

2016-11-07

Smoking is the largest cause of preventable death globally. Most smokers smoke their first cigarette in early adolescence. We took advantage of the widespread availability of mobile phones and adolescents' interest in appearance to develop a free photoaging app which is promoted via a poster campaign in secondary schools. This study aims to evaluate its effectiveness regarding smoking prevalence and students' attitudes towards smoking. A randomised controlled trial is conducted with 9851 students of both genders with an average age of 12 years in grades 6 and 7 of 126 secondary schools in Germany. At present, cigarette smoking prevalence in our sample is 4.7%, with 4.6% of the students currently using e-cigarettes (1.6% use both). The prospective experimental study design includes measurements at baseline and at 6, 12 and 24 months postintervention via a questionnaire plus a random cotinine saliva sample at 24 months postintervention. The study groups consist of randomised schools receiving the Smokerface poster campaign and control schools with comparable baseline data (no intervention). The primary end point is the difference of change in smoking prevalence in the intervention group versus the difference in the control group at 24 months follow-up. Longitudinal changes in smoking-related attitudes, the number of new smokers and quitters and the change in the number of never-smokers will be compared between the two groups as secondary outcomes. Ethical approval was obtained from the ethics committee of the University of Gießen and the ministries of cultural affairs, both in Germany. Results will be disseminated at conferences, in peer-reviewed journals, on our websites and throughout the multinational Education Against Tobacco network. NCT02544360, Pre-results. 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/.

Initiation of insulin glargine therapy in type 2 diabetes subjects suboptimally controlled on oral antidiabetic agents: results from the AT.LANTUS trial.

PubMed

Davies, M; Lavalle-González, F; Storms, F; Gomis, R

2008-05-01

For many patients with type 2 diabetes, oral antidiabetic agents (OADs) do not provide optimal glycaemic control, necessitating insulin therapy. Fear of hypoglycaemia is a major barrier to initiating insulin therapy. The AT.LANTUS study investigated optimal methods to initiate and maintain insulin glargine (LANTUS, glargine, Sanofi-aventis, Paris, France) therapy using two treatment algorithms. This subgroup analysis investigated the initiation of once-daily glargine therapy in patients suboptimally controlled on multiple OADs. This study was a 24-week, multinational (59 countries), multicenter (611), randomized study. Algorithm 1 was a clinic-driven titration and algorithm 2 was a patient-driven titration. Titration was based on target fasting blood glucose < or =100 mg/dl (< or =5.5 mmol/l). Algorithms were compared for incidence of severe hypoglycaemia [requiring assistance and blood glucose <50 mg/dl (<2.8 mmol/l)] and baseline to end-point change in haemoglobin A(1c) (HbA(1c)). Of the 4961 patients enrolled in the study, 865 were included in this subgroup analysis: 340 received glargine plus 1 OAD and 525 received glargine plus >1 OAD. Incidence of severe hypoglycaemia was <1%. HbA(1c) decreased significantly between baseline and end-point for patients receiving glargine plus 1 OAD (-1.4%, p < 0.001; algorithm 1 -1.3% vs. algorithm 2 -1.5%; p = 0.03) and glargine plus >1 OAD (-1.7%, p < 0.001; algorithm 1 -1.5% vs. algorithm 2 -1.8%; p = 0.001). This study shows that initiation of once-daily glargine with OADs results in significant reduction of HbA(1c) with a low risk of hypoglycaemia. The greater reduction in HbA(1c) was seen in patients randomized to the patient-driven algorithm (algorithm 2) on 1 or >1 OAD.

Photoaging smartphone app promoting poster campaign to reduce smoking prevalence in secondary schools: the Smokerface Randomized Trial: design and baseline characteristics

PubMed Central

Holzapfel, Julia; Baudson, Tanja G; Sies, Katharina; Jakob, Lena; Baumert, Hannah Maria; Heckl, Marlene; Cirac, Ana; Suhre, Janina L; Mathes, Verena; Spielmann, Hannah; Rigotti, Nancy; Herth, Felix; Groneberg, David A; Raupach, Tobias; Gall, Henning; Bauer, Claudia; Marek, Pat; Batra, Anil; Harrison, Chase H; Taha, Lava; Owczarek, Andreas; Hofmann, Felix J; Thomas, Roger; Mons, Ute; Kreuter, Michael

2016-01-01

Introduction Smoking is the largest cause of preventable death globally. Most smokers smoke their first cigarette in early adolescence. We took advantage of the widespread availability of mobile phones and adolescents’ interest in appearance to develop a free photoaging app which is promoted via a poster campaign in secondary schools. This study aims to evaluate its effectiveness regarding smoking prevalence and students’ attitudes towards smoking. Methods and analysis A randomised controlled trial is conducted with 9851 students of both genders with an average age of 12 years in grades 6 and 7 of 126 secondary schools in Germany. At present, cigarette smoking prevalence in our sample is 4.7%, with 4.6% of the students currently using e-cigarettes (1.6% use both). The prospective experimental study design includes measurements at baseline and at 6, 12 and 24 months postintervention via a questionnaire plus a random cotinine saliva sample at 24 months postintervention. The study groups consist of randomised schools receiving the Smokerface poster campaign and control schools with comparable baseline data (no intervention). The primary end point is the difference of change in smoking prevalence in the intervention group versus the difference in the control group at 24 months follow-up. Longitudinal changes in smoking-related attitudes, the number of new smokers and quitters and the change in the number of never-smokers will be compared between the two groups as secondary outcomes. Ethics and dissemination Ethical approval was obtained from the ethics committee of the University of Gießen and the ministries of cultural affairs, both in Germany. Results will be disseminated at conferences, in peer-reviewed journals, on our websites and throughout the multinational Education Against Tobacco network. Trial registration number NCT02544360, Pre-results. PMID:27821601

Using English as the Common Corporate Language in a German Multinational

ERIC Educational Resources Information Center

Swift, Jonathan S.; Wallace, James

2011-01-01

Purpose: This study aims to examine a German multinational that uses English as the common corporate language (CCL) for internal communications with its international subsidiaries/agencies. It examines use of English within the workplace, and problems/opportunities it presents to those who use it. Design/methodology: The questionnaire was piloted…

Assessment of a Multinational Online Faculty Development Program on Online Teaching: Reflections of Candidate E-Tutors

ERIC Educational Resources Information Center

Adnan, Muge; Kalelioglu, Filiz; Gulbahar, Yasemin

2017-01-01

Teaching online requires different skills, roles and competencies for online instructors compared to teaching in traditional learning environments. Universities should offer ongoing support in various forms to help academic staff through their online journey. This paper provides insights into a multinational faculty development program for…

Developing Managerial Talent: Exploring the Link between Management Talent and Perceived Performance in Multinational Corporations (MNCs)

ERIC Educational Resources Information Center

Sheehan, Maura

2012-01-01

Purpose: To examine the association between talent management (TM) and perceived subsidiary performance. Focus is given to the development of one key talent group--line managers--in subsidiaries of multinational corporations (MNCs). Specifically, the paper examines: whether there is a positive relationship between Management Development (MD) and…

Measuring the Value of Succession Planning and Management: A Qualitative Study of Multinational Companies

ERIC Educational Resources Information Center

Kim, Yeonsoo

2010-01-01

This article proposes a model for planning and operating an effective succession planning and management (SP&M) program and measuring its value. The nature of the research is exploratory, following a qualitative approach using in-depth interviews. Representatives of multinational companies interviewed for this study revealed that succession…

The Status of International Business Communication Training in the 100 Largest Multinational United States Corporations.

ERIC Educational Resources Information Center

Zimpfer, Forest; Underwood, Robert

The 100 largest multinational U.S. corporations were surveyed concerning business communication training provided for personnel assigned to overseas posts. The survey requested information on the existence and content of such formal training programs and the qualifications of their training directors. Results drawn from the 43 usable responses…

Pre-Interaction Management in Multinational Companies in Central Europe

ERIC Educational Resources Information Center

Nekvapil, Jiri; Sherman, Tamah

2009-01-01

This article is devoted to the linguistic, communicative and sociocultural situation in branches of multinational companies located in the Czech Republic and Hungary. There are typically several languages used in these branches. In addition to the local languages, there are the languages of the parent companies--most commonly English or German,…

Confucius Institutes: Distributed Leadership and Knowledge Sharing in a Worldwide Network

ERIC Educational Resources Information Center

Li, Hsi Chang; Mirmirani, Sam; Ilacqua, Joseph A.

2009-01-01

Purpose: The purpose of this paper is to focus on Confucius Institutes and assess the applicability of theories of leadership and knowledge sharing to multinational organizations and worldwide networks. Growth of multinational trade and decrease in international tension have facilitated the globalization of both profit-seeking and non-profit…

Knowledge Sharing in an American Multinational Company Based in Malaysia

ERIC Educational Resources Information Center

Ling, Chen Wai; Sandhu, Manjit S.; Jain, Kamal Kishore

2009-01-01

Purpose: This paper seeks to examine the views of executives working in an American based multinational company (MNC) about knowledge sharing, barriers to knowledge sharing, and strategies to promote knowledge sharing. Design/methodology/approach: This study was carried out in phases. In the first phase, a topology of organizational mechanisms for…

National Bibliography in a Multi-National State as Accomplished in the USSR.

ERIC Educational Resources Information Center

Vesirova, L. A.

Soviet national bibliographies register all types of publications printed in the Soviet Union regardless of the language in which they were published. These bibliographies are known as state bibliographies. This report dwells on the characteristics of the organization of a state bibliographic system in a multi-national socialistic state. The…

Safety and Health in Multinational Enterprises: What Have We Learnt?

ERIC Educational Resources Information Center

Romero, Ana Teresa

1993-01-01

Analyzes the practices of multinationals in the sphere of occupational safety and health and poses the question of safety and health and industrial risks in terms of environmental problems. Indicates that the future of safety and health may hinge on the adaptation and implementation of recommendations of International Labour Organisation members.…

Developing Collaboratively an International School Special Needs Plan for Multicultural, Multilingual, and Multinational Secondary Students.

ERIC Educational Resources Information Center

Jonietz, Patricia L.

The International School of Brussels (Belgium) developed a program of Curriculum-Based Assessment (CBA) to increase support for "at risk" multicultural, multilingual, and multinational students. The at-risk population included three groups: those who passed standardized English as a Foreign Language tests but were not literate enough for…

“A question of balance”: addressing the public health impacts of multinational enterprises in the OECD Guidelines for Multinational Enterprises

PubMed Central

Yang, Joshua S.; McDaniel, Patricia A.; Malone, Ruth E.

2012-01-01

Background The global community is beginning to address non-communicable diseases, but how to increase the accountability of multinational enterprises (MNEs) for the health impacts of their products and practices remains unclear. We examine the Organization for Economic Cooperation and Development’s (OECD) efforts to do so through voluntary MNE guidelines. Methods We developed a historical case study of how the OECD Guidelines for Multinational Enterprises were developed and revised from 1973–2000 through an analysis of publicly available archived OECD and tobacco industry documents. Results The first edition of the Guidelines was a purely economic instrument. Outside pressures and a desire to ward off more stringent regulatory efforts resulted in the addition over time of guidelines related to the environment, consumer interests, sustainable development, and human rights. Conclusion Despite their voluntary nature, the Guidelines can play a role in efforts to help balance the interests of MNEs and public health by providing a starting point for efforts to create binding provisions addressing MNEs’ contributions to disease burden or disease reduction. PMID:23046298

Patient-led versus physician-led titration of insulin glargine in patients with uncontrolled type 2 diabetes: a randomized multinational ATLAS study.

PubMed

Garg, Satish K; Admane, Karim; Freemantle, Nick; Odawara, Masato; Pan, Chang-Yu; Misra, Anoop; Jarek-Martynowa, Iwona R; Abbas-Raza, Syed; Mirasol, Roberto C; Perfetti, Riccardo

2015-02-01

Self-adjustment of insulin dose is commonly practiced in Western patients with type 2 diabetes but is usually not performed in Asian patients. This multinational, 24-week, randomized study compared patient-led with physician-led titration of once-daily insulin glargine in Asian patients with uncontrolled type 2 diabetes who were on 2 oral glucose-lowering agents. Patient-led (n = 275) or physician-led (n = 277) subjects followed the same dose-titration algorithm guided by self-monitored fasting blood glucose (FBG; target, 110 mg/dL [6.1 mmol/L]). The primary endpoint was change in mean glycated hemoglobin (HbA1c) at week 24 in the patient-led versus physician-led titration groups. Patient-led titration resulted in a significantly higher drop in HbA1c value at 24 weeks when compared with physician-led titration (-1.40% vs. -1.25%; mean difference, -0.15; 95% confidence interval, -0.29 to 0.00; P = .043). Mean decrease in FBG was greatest in the patient-led group (-2.85 mmol/L vs. -2.48 mmol/L; P = .001). The improvements in HbA1c and FBG were consistent across countries, with similar improvements in treatment satisfaction in both groups. Mean daily insulin dose was higher in the patient-led group (28.9 units vs. 22.2 units; P<.001). Target HbA1c of <7.0% without severe hypoglycemia was achieved in 40.0% and 32.9% in the patient-led and physician-led groups, respectively (P = .086). Severe hypoglycemia was not different in the 2 groups (0.7%), with an increase in nocturnal and symptomatic hypoglycemia in the patient-led arm. Patient-led insulin glargine titration achieved near-target blood glucose levels in Asian patients with uncontrolled type 2 diabetes who were on 2 oral glucose-lowering drugs, demonstrating that Asian patients can self-uptitrate insulin dose effectively when guided.

Pre-cART Elevation of CRP and CD4+ T-Cell Immune Activation Associated With HIV Clinical Progression in a Multinational Case-Cohort Study.

PubMed

Balagopal, Ashwin; Asmuth, David M; Yang, Wei-Teng; Campbell, Thomas B; Gupte, Nikhil; Smeaton, Laura; Kanyama, Cecilia; Grinsztejn, Beatriz; Santos, Breno; Supparatpinyo, Khuanchai; Badal-Faesen, Sharlaa; Lama, Javier R; Lalloo, Umesh G; Zulu, Fatima; Pawar, Jyoti S; Riviere, Cynthia; Kumarasamy, Nagalingeswaran; Hakim, James; Li, Xiao-Dong; Pollard, Richard B; Semba, Richard D; Thomas, David L; Bollinger, Robert C; Gupta, Amita

2015-10-01

Despite the success of combination antiretroviral therapy (cART), a subset of HIV-infected patients who initiate cART develop early clinical progression to AIDS; therefore, some cART initiators are not fully benefitted by cART. Immune activation pre-cART may predict clinical progression in cART initiators. A case-cohort study (n = 470) within the multinational Prospective Evaluation of Antiretrovirals in Resource-Limited Settings clinical trial (1571 HIV treatment-naive adults who initiated cART; CD4 T-cell count <300 cells/mm; 9 countries) was conducted. A subcohort of 30 participants per country was randomly selected; additional cases were added from the main cohort. Cases [n = 236 (random subcohort 36; main cohort 200)] had clinical progression (incident WHO stage 3/4 event or death) within 96 weeks after cART initiation. Immune activation biomarkers were quantified pre-cART. Associations between biomarkers and clinical progression were examined using weighted multivariable Cox-proportional hazards models. Median age was 35 years, 45% were women, 49% black, 31% Asian, and 9% white. Median CD4 T-cell count was 167 cells per cubic millimeter. In multivariate analysis, highest quartile C-reactive protein concentration [adjusted hazard ratio (aHR), 2.53; 95% confidence interval (CI): 1.02 to 6.28] and CD4 T-cell activation (aHR, 5.18; 95% CI: 1.09 to 24.47) were associated with primary outcomes, compared with lowest quartiles. sCD14 had a trend toward association with clinical failure (aHR, 2.24; 95% CI: 0.96 to 5.21). Measuring C-reactive protein and CD4 T-cell activation may identify patients with CD4 T-cell counts <300 cells per cubic millimeter at risk for early clinical progression when initiating cART. Additional vigilance and symptom-based screening may be required in this subset of patients even after beginning cART.

Pre-cART Elevation of CRP and CD4+ T-cell Immune Activation Associated with HIV Clinical Progression in a Multinational Case-Cohort Study

PubMed Central

Balagopal, Ashwin; Asmuth, David M.; Yang, Wei-Teng; Campbell, Thomas B.; Gupte, Nikhil; Smeaton, Laura; Kanyama, Cecilia; Grinsztejn, Beatriz; Santos, Breno; Supparatpinyo, Khuanchai; Badal-Faesen, Sharlaa; Lama, Javier R.; Lalloo, Umesh G.; Zulu, Fatima; Pawar, Jyoti S; Riviere, Cynthia; Kumarasamy, Nagalingeswaran; Hakim, James; Li, Xiao-Dong; Pollard, Richard B.; Semba, Richard D.; Thomas, David L.; Bollinger, Robert C.; Gupta, Amita

2015-01-01

Background Despite the success of combination antiretroviral therapy (cART), a subset of HIV-infected patients who initiate cART develop early clinical progression to AIDS; therefore some cART initiators are not fully benefitted by cART. Immune activation pre-cART may predict clinical progression in cART initiators. Methods A case-cohort study (n=470) within the multinational Prospective Evaluation of Antiretrovirals in Resource-Limited Settings (PEARLS) clinical trial (1571 HIV treatment-naïve adults who initiated cART; CD4+ T cell count <300 cells/mm3; nine countries) was conducted. A subcohort of 30 participants/country was randomly selected; additional cases were added from the main cohort. Cases (n=236 [random subcohort–36; main cohort–200]) had clinical progression (incident WHO Stage 3/4 event or death) within 96 weeks following cART initiation. Immune activation biomarkers were quantified pre-cART. Associations between biomarkers and clinical progression were examined using weighted multivariable Cox-proportional hazards models. Results Median age was 35 years, 45% were women, 49% black, 31% Asian, and 9% white. Median CD4+ T-cell count was 167 cells/mm3. In multivariate analysis, highest quartile CRP concentration (adjusted hazards ratio [aHR] 2.53, 95%CI 1.02-6.28) and CD4+ T-cell activation (aHR 5.18, 95CI 1.09-24.47) were associated with primary outcomes, compared to lowest quartiles. sCD14 had a trend towards association with clinical failure (aHR 2.24, 95%CI 0.96–5.21). Conclusions Measuring CRP and CD4+ T-cell activation may identify patients with CD4+ T cell counts < 300 cells/mm3 at risk for early clinical progression when initiating cART. Additional vigilance and symptom-based screening may be required in this subset of patients even after beginning cART. PMID:26017661

Renal and Metabolic Toxicities Following Initiation of HIV-1 Treatment Regimen in a Diverse, Multinational Setting: A Focused Safety Analysis of ACTG PEARLS (A5175)

PubMed Central

Romo, F. Touzard; Smeaton, L.M.; Campbell, T.B.; Riviere, C.; Mngqibisa, R.; Nyirenda, M.; Supparatpinyo, K.; Kumarasamy, N.; Hakim, J.G.; Flanigan, T.P.

2015-01-01

Background Convenient dosing, potency, and low toxicity support use of tenofovir disoproxil fumarate (TDF) as preferred nucleotide reverse transcriptase inhibitor (NRTI) for HIV-1 treatment. However, renal and metabolic safety of TDF compared to other NRTIs has not been well described in resource-limited settings. Methods This was a secondary analysis examining the occurrence of renal abnormalities (RAs) and renal and metabolic serious non-AIDS-defining events (SNADEs) through study follow-up between participants randomized to zidovudine (ZDV)/lamivudine/efavirenz and TDF/emtricitabine/efavirenz treatment arms within A5175/PEARLS trial. Exact logistic regression explored associations between baseline covariates and RAs. Response profile longitudinal analysis compared creatinine clearance (CrCl) over time between NRTI groups. Results Twenty-one of 1,045 participants developed RAs through 192 weeks follow-up; there were 15 out of 21 in the TDF arm (P = .08). Age 41 years or older (odds ratio [OR], 3.35; 95% CI, 1.1–13.1), history of diabetes (OR, 10.7; 95% CI, 2.1–55), and lower baseline CrCl (OR, 3.1 per 25 mL/min decline; 95% CI, 1.7–5.8) were associated with development of RAs. Renal SNADEs occurred in 42 participants; 33 were urinary tract infections and 4 were renal failure/insufficiency; one event was attributed to TDF. Significantly lower CrCl values were maintained among patients receiving TDF compared to ZDV (repeated measures analysis P = .05), however worsening CrCl from baseline was not observed with TDF exposure over time. Metabolic SNADEs were rare, but were higher in the ZDV arm (20 vs 3; P < .001). Conclusions TDF is associated with lower serious metabolic toxicities but not higher risk of RAs, serious renal events, or worsening CrCl over time compared to ZDV in this randomized multinational study. PMID:25433664

Pretreatment HIV Drug Resistance and HIV-1 Subtype C Are Independently Associated With Virologic Failure: Results From the Multinational PEARLS (ACTG A5175) Clinical Trial

PubMed Central

Kantor, Rami; Smeaton, Laura; Vardhanabhuti, Saran; Hudelson, Sarah E.; Wallis, Carol L.; Tripathy, Srikanth; Morgado, Mariza G.; Saravanan, Shanmugham; Balakrishnan, Pachamuthu; Reitsma, Marissa; Hart, Stephen; Mellors, John W.; Halvas, Elias; Grinsztejn, Beatriz; Hosseinipour, Mina C.; Kumwenda, Johnstone; La Rosa, Alberto; Lalloo, Umesh G.; Lama, Javier R.; Rassool, Mohammed; Santos, Breno R.; Supparatpinyo, Khuanchai; Hakim, James; Flanigan, Timothy; Kumarasamy, Nagalingeswaran; Campbell, Thomas B.; Eshleman, Susan H.

2015-01-01

Background. Evaluation of pretreatment HIV genotyping is needed globally to guide treatment programs. We examined the association of pretreatment (baseline) drug resistance and subtype with virologic failure in a multinational, randomized clinical trial that evaluated 3 antiretroviral treatment (ART) regimens and included resource-limited setting sites. Methods. Pol genotyping was performed in a nested case-cohort study including 270 randomly sampled participants (subcohort), and 218 additional participants failing ART (case group). Failure was defined as confirmed viral load (VL) >1000 copies/mL. Cox proportional hazards models estimated resistance–failure association. Results. In the representative subcohort (261/270 participants with genotypes; 44% women; median age, 35 years; median CD4 cell count, 151 cells/µL; median VL, 5.0 log10 copies/mL; 58% non-B subtypes), baseline resistance occurred in 4.2%, evenly distributed among treatment arms and subtypes. In the subcohort and case groups combined (466/488 participants with genotypes), used to examine the association between resistance and treatment failure, baseline resistance occurred in 7.1% (9.4% with failure, 4.3% without). Baseline resistance was significantly associated with shorter time to virologic failure (hazard ratio [HR], 2.03; P = .035), and after adjusting for sex, treatment arm, sex–treatment arm interaction, pretreatment CD4 cell count, baseline VL, and subtype, was still independently associated (HR, 2.1; P = .05). Compared with subtype B, subtype C infection was associated with higher failure risk (HR, 1.57; 95% confidence interval [CI], 1.04–2.35), whereas non-B/C subtype infection was associated with longer time to failure (HR, 0.47; 95% CI, .22–.98). Conclusions. In this global clinical trial, pretreatment resistance and HIV-1 subtype were independently associated with virologic failure. Pretreatment genotyping should be considered whenever feasible. Clinical Trials Registration. NCT00084136. PMID:25681380

The food choice at work study: effectiveness of complex workplace dietary interventions on dietary behaviours and diet-related disease risk - study protocol for a clustered controlled trial

PubMed Central

2013-01-01

Background Dietary behaviour interventions have the potential to reduce diet-related disease. Ample opportunity exists to implement these interventions in the workplace. The overall aim is to assess the effectiveness and cost-effectiveness of complex dietary interventions focused on environmental dietary modification alone or in combination with nutrition education in large manufacturing workplace settings. Methods/design A clustered controlled trial involving four large multinational manufacturing workplaces in Cork will be conducted. The complex intervention design has been developed using the Medical Research Council’s framework and the National Institute for Health and Clinical Excellence (NICE) guidelines and will be reported using the TREND statement for the transparent reporting of evaluations with non-randomized designs. It will draw on a soft paternalistic “nudge” theoretical perspective. Nutrition education will include three elements: group presentations, individual nutrition consultations and detailed nutrition information. Environmental dietary modification will consist of five elements: (a) restriction of fat, saturated fat, sugar and salt, (b) increase in fibre, fruit and vegetables, (c) price discounts for whole fresh fruit, (d) strategic positioning of healthier alternatives and (e) portion size control. No intervention will be offered in workplace A (control). Workplace B will receive nutrition education. Workplace C will receive nutrition education and environmental dietary modification. Workplace D will receive environmental dietary modification alone. A total of 448 participants aged 18 to 64 years will be selected randomly. All permanent, full-time employees, purchasing at least one main meal in the workplace daily, will be eligible. Changes in dietary behaviours, nutrition knowledge, health status with measurements obtained at baseline and at intervals of 3 to 4 months, 7 to 9 months and 13 to 16 months will be recorded. A process evaluation and cost-effectiveness economic evaluation will be undertaken. Discussion A 'Food Choice at Work’ toolbox (concise teaching kit to replicate the intervention) will be developed to inform and guide future researchers, workplace stakeholders, policy makers and the food industry. Trial registration Current Controlled Trials, ISRCTN35108237 PMID:24192134

The food choice at work study: effectiveness of complex workplace dietary interventions on dietary behaviours and diet-related disease risk - study protocol for a clustered controlled trial.

PubMed

Geaney, Fiona; Scotto Di Marrazzo, Jessica; Kelly, Clare; Fitzgerald, Anthony P; Harrington, Janas M; Kirby, Ann; McKenzie, Ken; Greiner, Birgit; Perry, Ivan J

2013-11-06

Dietary behaviour interventions have the potential to reduce diet-related disease. Ample opportunity exists to implement these interventions in the workplace. The overall aim is to assess the effectiveness and cost-effectiveness of complex dietary interventions focused on environmental dietary modification alone or in combination with nutrition education in large manufacturing workplace settings. A clustered controlled trial involving four large multinational manufacturing workplaces in Cork will be conducted. The complex intervention design has been developed using the Medical Research Council's framework and the National Institute for Health and Clinical Excellence (NICE) guidelines and will be reported using the TREND statement for the transparent reporting of evaluations with non-randomized designs. It will draw on a soft paternalistic 'nudge' theoretical perspective. It will draw on a soft paternalistic "nudge" theoretical perspective. Nutrition education will include three elements: group presentations, individual nutrition consultations and detailed nutrition information. Environmental dietary modification will consist of five elements: (a) restriction of fat, saturated fat, sugar and salt, (b) increase in fibre, fruit and vegetables, (c) price discounts for whole fresh fruit, (d) strategic positioning of healthier alternatives and (e) portion size control. No intervention will be offered in workplace A (control). Workplace B will receive nutrition education. Workplace C will receive nutrition education and environmental dietary modification. Workplace D will receive environmental dietary modification alone. A total of 448 participants aged 18 to 64 years will be selected randomly. All permanent, full-time employees, purchasing at least one main meal in the workplace daily, will be eligible. Changes in dietary behaviours, nutrition knowledge, health status with measurements obtained at baseline and at intervals of 3 to 4 months, 7 to 9 months and 13 to 16 months will be recorded. A process evaluation and cost-effectiveness economic evaluation will be undertaken. A 'Food Choice at Work' toolbox (concise teaching kit to replicate the intervention) will be developed to inform and guide future researchers, workplace stakeholders, policy makers and the food industry. Current Controlled Trials, ISRCTN35108237.

[Style of communication between mission control centers and space crews].

PubMed

Iusupova, A K; Gushchin, V I; Shved, D M; Cheveleva, L M

2011-01-01

The article deals with a pilot investigation into the audio communication of cosmonauts with ground controllers. The purpose was to verify in space flight the patterns and trends revealed in model tests of intergroup communication, and to pinpoint the signature of multinational crew communication with 2 national mission control centers (MCCs). The investigation employed authors' content-analysis adapted to the scenario of long-duration mission. The investigation resulted in a phenomenon of double-loop ground-orbit communication, divergence, difference in opinion predictable from the concept formulated by G.T.Beregovoi. Also, there was a notable difference of expressions used by controllers of 2 MCCs.

Towards evidence-based medicine in specific grass pollen immunotherapy.

PubMed

Calderon, M; Mösges, R; Hellmich, M; Demoly, P

2010-04-01

When initiating grass pollen immunotherapy for seasonal allergic rhinoconjunctivitis, specialist physicians in many European countries must choose between modalities of differing pharmaceutical and regulatory status. We applied an evidence-based medicine (EBM) approach to commercially available subcutaneous and sublingual Gramineae grass pollen immunotherapies (SCIT and SLIT) by evaluating study design, populations, pollen seasons, treatment doses and durations, efficacy, quality of life, safety and compliance. After searching MEDLINE, Embase and the Cochrane Library up until January 2009, we identified 33 randomized, double-blind, placebo-controlled trials (including seven paediatric trials) with a total of 440 specific immunotherapy (SIT)-treated subjects in seven trials (0 paediatric) for SCIT with natural pollen extracts, 168 in three trials (0 paediatric) for SCIT with allergoids, 906 in 16 trials (five paediatric) for natural extract SLIT drops, 41 in two trials (one paediatric) for allergoid SLIT tablets and 1605 in five trials (two paediatric) for natural extract SLIT tablets. Trial design and quality varied significantly within and between SIT modalities. The multinational, rigorous trials of natural extract SLIT tablets correspond to a high level of evidence in adult and paediatric populations. The limited amount of published data on allergoids prevented us from judging the level of evidence for this modality.

Multinational medical support to operations: challenges, benefits and recommendations for the future.

PubMed

Cordell, R F

2012-03-01

This paper considers the strategic aspects of medical support to military operations as delivered through multi-national collaboration. The military medical services are in essence a people organisation; the purpose of the organisation is primarily to support the people engaged in military operations, and also the people providing healthcare to them. Increasingly, supporting the latter also includes preparation for the ethical dilemmas that they will face. Providing health advice and healthcare on operations is now usually undertaken on a multinational basis, in order to generate sufficient medical capacity to meet the requirement with assets of the appropriate (and NATO mandated) capability. This will be an enduring feature, particularly in light of increasing costs of providing high quality healthcare and the operational and logistic challenges of delivering this capability in adverse environments, and in the context of medical personnel being a limited resource. The key to overcoming the challenges, often the result of the "people issues" such as cultural differences, is to recognise the value that the inherent diversity of multinational healthcare provision brings. The benefit is realised through sharing best practice, and the lessons from challenges met, as well as through burden sharing, and to understand that challenges are most commonly the result of misunderstandings, such as those inherent in language differences. The advice for those bringing a multinational team together includes considering the implications of culture (noting differences in national and military perspectives, and in medical processes such as clinical governance), to ensure effective communication, and to utilise feedback to confirm understanding. It is important not to prejudge or denigrate others. Share information and knowledge, provide positive reinforcement when things go well, and recognise that there will inevitably be challenges and use these as an opportunity to learn. Above all, the personal touch builds a culture within the multinational team that transcends national culture; celebrating success breeds success and thus optimal outcome for patients.

Progress and problems for randomized clinical trials: from streptomycin to the era of megatrials.

PubMed

Hilbrich, Lutz; Sleight, Peter

2006-09-01

Randomized clinical trials (RCTs) are the definitive contributors to evidence-based medicine. RCTs assessing serious outcomes in cardiovascular disease have grown, with 'megatrials' becoming more common with the realization that wrong conclusions resulted from random error in inadequately sized trials. Simple design and a heterogeneous patient population were early features, but multinational trials have increased in scientific, logistical, bureaucratic, regulatory, and legal complexity. These studies now exceed the financial means of academia or medical charities. Governments have left the bill with the pharmaceutical industry, encouraging a symbiosis with academics, who contribute medical and scientific expertise, and access to patients. Industry provides pharmacological, pharmaceutical, technical and regulatory know-how, good clinical practice expertise, and legal assistance during the trial. Study supervision is then in the hands of an independent steering committee and associated subcommittees, until appropriate dissemination of results. Prospectively defined interaction with the sponsor facilitates unbiased design and conduct, but arrangements need careful implementation to avoid conflicts of interest. The patient is protected by a strong data safety monitoring board that is wholly independent. Megatrials are under threat from over-regulation, increasing costs, and difficulties in execution. These issues merit urgent public and political education and debate.

Results of the Stent-Protected Angioplasty versus Carotid Endarterectomy (SPACE) study to treat symptomatic stenoses at 2 years: a multinational, prospective, randomised trial.

PubMed

Eckstein, Hans-Henning; Ringleb, Peter; Allenberg, Jens-Rainer; Berger, Jürgen; Fraedrich, Gustav; Hacke, Werner; Hennerici, Michael; Stingele, Robert; Fiehler, Jens; Zeumer, Hermann; Jansen, Olav

2008-10-01

The SPACE trial is a multinational, prospective, randomised study to test the hypothesis that carotid artery stenting is not inferior to carotid endarterectomy for treating patients with severe symptomatic carotid artery stenosis. We did not prove non-inferiority of carotid artery stenting compared with carotid endarterectomy for the 30-day complication rate, and we now report the results at 2 years. Between March, 2001, and February, 2006, patients with symptomatic, severe (>or=70%) carotid artery stenosis were recruited to this non-inferiority trial and randomly assigned with a block randomisation design to have carotid artery angioplasty with stenting or carotid artery endarterectomy. 2-year endpoints include several clinical endpoints and the incidence of recurrent carotid stenosis of at least 70%. Clinical and vascular follow-up was done by a certified neurologist. Analyses were by intention to treat and per protocol. This trial is registered with ISRCTN, number 57874028.12. 1 214 patients were randomly assigned (613 were randomly assigned to carotid angioplasty with stenting and 601 were randomly assigned to carotid endarterectomy). In both the intention-to-treat and per-protocol analyses the Kaplan-Meier estimates of ipsilateral ischaemic strokes up to 2 years after the procedure and any periprocedural stroke or death do not differ between the carotid artery stenting and the carotid endarterectomy groups (intention to treat 9.5%vs 8.8%; hazard ratio (HR) 1.10, 95%CI 0.75 to 1.61; log-rank p=0.62; per protocol 9.4%vs 7.8%; HR 1.23, 95%CI 0.82 to 1.83; log-rank p=0.31). In both the intention-to-treat and per-protocol populations, recurrent stenosis of 70% or more is significantly more frequent in the carotid artery stenting group compared with the carotid endarterectomy group, with a life-table estimate of 10.7% versus 4.6% (p=0.0009) and 11.1% versus 4.6% (p=0.0007), respectively. Only two incidences of recurrent stenoses after carotid artery stenting led to neurological symptoms. After 2 years' follow-up, the rate of recurrent ipsilateral ischaemic strokes reported in the SPACE trial is similar for both treatment groups. The incidence of recurrent carotid stenosis at 2 years, as defined by ultrasound, is significantly higher after carotid artery stenting. However, it cannot be excluded that the degree of in-stent stenosis is slightly overestimated by conventional ultrasound criteria.

Continuous Linguistic Rhetorical Education as a Means of Optimizing Language Policy in Russian Multinational Regions

ERIC Educational Resources Information Center

Vorozhbitova, Alexandra A.; Konovalova, Galina M.; Ogneva, Tatiana N.; Chekulaeva, Natalia Y.

2017-01-01

Drawing on the function of Russian as a state language the paper proposes a concept of continuous linguistic rhetorical (LR) education perceived as a means of optimizing language policy in Russian multinational regions. LR education as an innovative pedagogical system shapes a learner's readiness for self-projection as a strong linguistic…

Human Resource Development Practices, Managers and Multinational Enterprises in Australia: Thinking Globally, Acting Locally

ERIC Educational Resources Information Center

Sablok, Gitika; Stanton, Pauline; Bartram, Timothy; Burgess, John; Boyle, Brendan

2017-01-01

Purpose: The purpose of this paper is to examine the HRD practices of multinational enterprises (MNEs) operating in Australia to understand the value that MNEs place on investment in their human capital, particularly managerial talent. Design/methodology/approach: Drawing on a representative sample of 211 MNEs operating in Australia, this paper…

The Multilingual Reality of the Multinational Workplace: Language Policy and Language Use

ERIC Educational Resources Information Center

Angouri, Jo

2013-01-01

In the multinational corporation (MNC) context the crossing of linguistic boundaries and the fast-paced change of linguistic ecologies due to market trends and new business activities is the rule rather than the exception. Accordingly, the aim of this paper is to discuss language policy and language practice in one consortium of three…

Army Engineers in a Joint and Multinational Environment

DTIC Science & Technology

2008-05-22

operatio 0 in a maneuver battalion in national ns. The battalion also lacked...construction management section (CMS) to fulfill these requirements and provide operatio mission guidance for the multinational units. The CMS, led by a lieuten...also deleting from the inventory the engineer group headquarters, relying 115 Andrew Feickert, “U.S. Army’s Modular Redesign: Issues for Congress

The International Collaboration for Autism Registry Epidemiology (iCARE): Multinational Registry-Based Investigations of Autism Risk Factors and Trends

ERIC Educational Resources Information Center

Schendel, Diana E.; Bresnahan, Michaeline; Carter, Kim W.; Francis, Richard W.; Gissler, Mika; Grønborg, Therese K.; Gross, Raz; Gunnes, Nina; Hornig, Mady; Hultman, Christina M.; Langridge, Amanda; Lauritsen, Marlene B.; Leonard, Helen; Parner, Erik T.; Reichenberg, Abraham; Sandin, Sven; Sourander, Andre; Stoltenberg, Camilla; Suominen, Auli; Surén, Pål; Susser, Ezra

2013-01-01

The International Collaboration for Autism Registry Epidemiology (iCARE) is the first multinational research consortium (Australia, Denmark, Finland, Israel, Norway, Sweden, USA) to promote research in autism geographical and temporal heterogeneity, phenotype, family and life course patterns, and etiology. iCARE devised solutions to challenges in…

Critical Success Factors: How One Multinational Company Develops Global E-Learning

ERIC Educational Resources Information Center

Nathan, Edward Pavel

2011-01-01

This research study examined how a multinational company determined what the critical success factors (CSFs) were for developing global e-learning. The study analyzed how these CSFs were grouped together to make their management more efficient. There were 21 participants in the study who were key stakeholders from the United States, Europe, Latin…

"Hej Seppo, Could You Pls Comment on This!"--Internal Email Communication in Lingua Franca English in a Multinational Company

ERIC Educational Resources Information Center

Kankaanranta, Anne

2006-01-01

Recent turbulence in the corporate world resulting from cross-border mergers and acquisitions and advances in communication technology has meant major changes for internal communication in multinational companies. For example, in Finnish-Swedish mergers the common corporate language is increasingly English even though Swedish has traditionally…

Critical Success Factors: How One Multinational Company Develops Global E-Learning

ERIC Educational Resources Information Center

Nathan, Edward Pavel

2009-01-01

This research study examined how a multinational company determined what the critical success factors (CSFs) were for developing global e-learning. The study analyzed how these CSFs were grouped together in order to make their management more efficient. There were 21 participants in the study who were key stakeholders and came from one of four…

A Survey of Current and Future Perceived Multi-National Corporation Manufacturing Training Needs in Tianjin, (T.E.D.A.) China.

ERIC Educational Resources Information Center

Hickey, Will

2001-01-01

Describes a study that surveyed current and perceived future employer-provided training practices among multinational corporations manufacturing companies in the Tianjin Economic Development Area (T.E.D.A.) of China. Highlights include labor market; human resources management in China; workforce productivity; and return on investment. (Author/LRW)

Cross-Cultural Adjustment Process of Expatriate Families in a Multinational Organization: A Family System Theory Perspective

ERIC Educational Resources Information Center

Rosenbusch, Katherine

2010-01-01

The purpose of this survey based study was to examine whether the characteristics (i.e., flexibility and cohesion) of expatriate families in a multinational corporation as measured by the Family Adaptability and Cohesion Evaluation Scale can predict cross-cultural adjustment of the expatriate (individual level of analysis) and his/her family…

Evaluating Knowledge, Attitudinal, and Behavioral Change Effects from a Multinational HIV/AIDS Education Program for Youth

ERIC Educational Resources Information Center

Hardre, Patricia L.; Garcia, Fe; Apamo, Peter; Mutheu, Lucy; Ndege, Monica; Bois, Iderle

2010-01-01

This project tracked the mid-term evaluation processes, practices, and products of a multinational program to reduce at-risk behaviors for HIV/AIDS among children in Kenya, Tanzania, and Haiti. It focused on participant and community perceptions; program effectiveness in promoting abstinence and monogamy decisions; and factors supporting ongoing…

Your Language or Mine? Or English as a Lingua Franca? Comparing Effectiveness in English as a Lingua Franca and L1-L2 Interactions: Implications for Corporate Language Policies

ERIC Educational Resources Information Center

van Mulken, Margot; Hendriks, Berna

2015-01-01

For multinational corporations, the need for efficiency and control has motivated the choice for a corporate language. However, increasing internationalisation has forced corporations to rethink their language policies to cater to the changing demands of the multicultural and multilingual workplace. This paper explores two related issues. First,…

U.S. Southwest Border Security: An Operational Approach

DTIC Science & Technology

2012-06-08

should be aware that notwithstanding any other provision of law , no person shall be subject to any penalty for failing to comply with a collection...Force – North LEA Law Enforcement Agency LTC Lieutenant Colonel MNC Multi-National Company MOE Measure of Effectiveness MOP Measure of Performance... NAFTA North American Free Trade Agreement NG National Guard ONDCP Office of National Drug Control Policy SGA Small Group Advisor TCO Transnational

Multinational corporations and health care in the United States and Latin America: strategies, actions, and effects.

PubMed

Jasso-Aguilar, Rebeca; Waitzkin, Howard; Landwehr, Angela

2004-01-01

In this article we analyze the corporate dominance of health care in the United States and the dynamics that have motivated the international expansion of multinational health care corporations, especially to Latin America. We identify the strategies, actions, and effects of multinational corporations in health care delivery and public health policies. Our methods have included systematic bibliographical research and in-depth interviews in the United States, Mexico, and Brazil. Influenced by public policy makers in the United States, such organizations as the World Bank, International Monetary Fund, and World Trade Organization have advocated policies that encourage reduction and privatization of health care and public health services previously provided in the public sector. Multinational managed care organizations have entered managed care markets in several Latin American countries at the same time as they were withdrawing from managed care activities in Medicaid and Medicare within the United States. Corporate strategies have culminated in a marked expansion of corporations' access to social security and related public sector funds for the support of privatized health services. International financial institutions and multinational corporations have influenced reforms that, while favorable to corporate interests, have worsened access to needed services and have strained the remaining public sector institutions. A theoretical approach to these problems emphasizes the falling rate of profit as an economic motivation of corporate actions, silent reform, and the subordination of polity to economy. Praxis to address these problems involves opposition to policies that enhance corporate interests while reducing public sector services, as well as alternative models that emphasize a strengthened public sector

Multinational Corporations and Health Care in the United States and Latin America: Strategies, Actions, and Effects*

PubMed Central

JASSO-AGUILAR, REBECA; WAITZKIN, HOWARD; LANDWEHR, ANGELA

2010-01-01

In this article we analyze the corporate dominance of health care in the United States and the dynamics that have motivated the international expansion of multinational health care corporations, especially to Latin America. We identify the strategies, actions, and effects of multinational corporations in health care delivery and public health policies. Our methods have included systematic bibliographical research and in-depth interviews in the United States, Mexico, and Brazil. Influenced by public policy makers in the United States, such organizations as the World Bank, International Monetary Fund, and World Trade Organization have advocated policies that encourage reduction and privatization of health care and public health services previously provided in the public sector. Multinational managed care organizations have entered managed care markets in several Latin American countries at the same time as they were withdrawing from managed care activities in Medicaid and Medicare within the United States. Corporate strategies have culminated in a marked expansion of corporations’ access to social security and related public sector funds for the support of privatized health services. International financial institutions and multinational corporations have influenced reforms that, while favorable to corporate interests, have worsened access to needed services and have strained the remaining public sector institutions. A theoretical approach to these problems emphasizes the falling rate of profit as an economic motivation of corporate actions, silent reform, and the subordination of polity to economy. Praxis to address these problems involves opposition to policies that enhance corporate interests while reducing public sector services, as well as alternative models that emphasize a strengthened public sector. PMID:15779471

Conducting multinational, cross-cultural research in the functional gastrointestinal disorders: issues and recommendations. A Rome Foundation working team report.

PubMed

Sperber, A D; Gwee, K A; Hungin, A P; Corazziari, E; Fukudo, S; Gerson, C; Ghoshal, U C; Kang, J-Y; Levy, R L; Schmulson, M; Dumitrascu, D; Gerson, M-J; Chen, M; Myung, S-J; Quigley, E M M; Whorwell, P J; Zarzar, K; Whitehead, W E

2014-11-01

Cross-cultural, multinational research can advance the field of functional gastrointestinal disorders (FGIDs). Cross-cultural comparative research can make a significant contribution in areas such as epidemiology, genetics, psychosocial modulators, symptom reporting and interpretation, extra-intestinal co-morbidity, diagnosis and treatment, determinants of disease severity, health care utilisation, and health-related quality of life, all issues that can be affected by geographical region, culture, ethnicity and race. To identify methodological challenges for cross-cultural, multinational research, and suggest possible solutions. This report, which summarises the full report of a working team established by the Rome Foundation that is available on the Internet, reflects an effort by an international committee of FGID clinicians and researchers. It is based on comprehensive literature reviews and expert opinion. Cross-cultural, multinational research is important and feasible, but has barriers to successful implementation. This report contains recommendations for future research relating to study design, subject recruitment, availability of appropriate study instruments, translation and validation of study instruments, documenting confounders, statistical analyses and reporting of results. Advances in study design and methodology, as well as cross-cultural research competence, have not matched technological advancements. The development of multinational research networks and cross-cultural research collaboration is still in its early stages. This report is intended to be aspirational rather than prescriptive, so we present recommendations, not guidelines. We aim to raise awareness of these issues and to pose higher standards, but not to discourage investigators from doing what is feasible in any particular setting. © 2014 John Wiley & Sons Ltd.

Theater Logistics Management: A Case for a Joint Distribution Solution

DTIC Science & Technology

2008-03-15

Multinational (JIIM) operations necessitate creating joint-multinational-based distribution management centers which effectively manage materiel...in the world. However, as the operation continued, the inherent weakness of the intra-theater logistical distribution management link became clear...compounded the distribution management problem. The common thread between each of the noted GAO failures is the lack of a defined joint, theater

Multinational Corporations and British Labour: A Review of Attitudes and Responses.

ERIC Educational Resources Information Center

Gennard, John

Multinational corporations operating in Great Britain, specifically American industry, are arousing fears on the part of British labor, which can be grouped into these categories: (1) a threat to the job security of union members, (2) a change in the balance of power at the collective bargaining table in favor of the employers, (3) a clash of…

The P15--A Multinational Assessment Battery for Collecting Data on Health Indicators Relevant to Adults with Intellectual Disabilities

ERIC Educational Resources Information Center

Perry, J.; Linehan, C.; Kerr, M.; Salvador-Carulla, L.; Zeilinger, E.; Weber, G.; Walsh, P.; Van Schrojenstein Lantman-De-Valk, H.; Haveman, M.; Azema, B.; Buono, S.; Cara, A. C.; Germanavicius, A.; Van Hove, G.; Maatta, T.; Berger, D. M.; Tossebro, J.

2010-01-01

Background: Health disparities between adults with intellectual disabilities (ID) and the general population have been well documented but, to date, no dedicated assessment battery for measuring health disparity has been available. This paper reports on the development and testing of a multinational assessment battery for collecting data on a…

Learning Experiences of Nurses as Part of a European Union Project on Complementary Therapies: A Multinational Qualitative Study.

PubMed

Boz, İlkay; Özer, Zeynep; Teskereci, Gamze; Kavradim, Selma Turan

The objectives of this study were to investigate learning experiences of the nurses who participated in transnational and multinational occupational training. A qualitative descriptive methodology was used. Data are clustered into 3 categories "occupational training," "complementary care," and "intercultural interaction." This research has revealed many insights into the transnational training of nurses.

Factors in the Effective Transfer of Knowledge from Multinational Enterprises to Their Foreign Subsidiaries: A Mozambican Case Study

ERIC Educational Resources Information Center

Duarte Moleiro Martins, José

2016-01-01

The purpose of this article is to better understand the role of internal stakeholders in subsidiaries of multinational companies (MNCs) in order to offer potential insights into the cross-border transfer of knowledge from those companies' headquarters to their subsidiaries. The focus is upon subsidiaries in developing countries, here Mozambique.…

The Invisible Blockade and the Covert War: U.S. Relations with Chile, 1970-1973

DTIC Science & Technology

1979-06-01

U.S.- owned multinational corporations , pursued a course of action, publicly, economically and covertly, bent on discrediting, disrupting and dislodging...government, in concert with U.S.- .owned multinational corporations , pursued a course of action, publicly, economically and covertly, bent on...513 E. CONCLUSION -------------------------------------- 64 IV. COVERT GOVERNMENTAL AND CORPORATE PRESSURES-------- 67 A. ATTEMPTS TO KEEP

Multinational corporations, the politics of the world economy, and their effects on women's health in the developing world: a review.

PubMed

Hippert, Christine

2002-12-01

Presently, globalization and the world economy maintain power relations that hamper the economic integrity and the political autonomy of the developing world. My paper addresses specific economic conditions that perpetuate poverty and poor health. I examine multinational corporations and their effects on women's health, particularly in Mexico and parts of Asia. The advent of multinational corporate business in Mexico, Malaysia, Philippines, India, and Indonesia has led to increased poverty and human rights abuses. Women bear the brunt of this because of specific international economic arrangements and their low social status, both locally and globally. As a result, their physical, mental, and emotional health is suffering. Solutions to these health problems have been proposed on multiple levels: international top-down approaches (i.e., employing international protectionist regulatory standards, exposing multinationals who infringe on their workers' human rights), as well as local grassroots organizational campaigns (i.e., conducting informational human rights workshops for factory workers). Ultimately, the answers lie in holding corporations accountable to their laborers while developing countries maintain their comparative advantage; this is the only way women's health will improve and the developing world can entice corporate investment.

International taxation of multinational enterprises in developed countries

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

Adams, J.D.R.; Whalley, J.

1977-01-01

The authors, specialists in law and economics, respectively, adopt an interdisciplinary approach to the international taxation of multinational corporations in developed countries, with particular emphasis on the EEC and the United States, integrating both legal and economic aspects of the subject. Since the international nature of the activities of multinational companies brings them within the scope of the domestic tax provisions of different countries, the authors outline the principles behind the domestic tax treatment of companies, and then assess the economic impact of this treatment. They subsequently examine the international taxation of multinationals, paying special attention to the OECD modelmore » treaty which seeks to remove the problem of international double taxation; reactions of governments to each other's fiscal policies are also examined, with special attention being paid to tax havens. Finally, they look at the EEC proposals for the harmonization of corporate tax systems within the Community and postulate how these proposals would operate if put into effect. There are numerous examples throughout the book of international taxation at work, and these together with the clear text provide a readily comprehensible account of a subject that can seem highly complicated to the uninitiated.« less

Thrombolysis for acute ischaemic stroke with alteplase in an Asian population: results of the multicenter, multinational Safe Implementation of Thrombolysis in Stroke-Non-European Union World (SITS-NEW).

PubMed

Rha, Joung-Ho; Shrivastava, Vasantha Padma; Wang, Yongjun; Lee, Kim En; Ahmed, Niaz; Bluhmki, Erich; Hermansson, Karin; Wahlgren, Nils

2014-10-01

Safe Implementation of Thrombolysis in Stroke-Non-European Union World was a multinational, prospective, open, monitored, observational study of intravenous alteplase as thrombolytic therapy in clinical practice. Safe Implementation of Thrombolysis in Stroke-Non-European Union World was required to assess the safety of alteplase in an Asian population by comparison with results from the European Safe Implementation of Thrombolysis in Stroke-Monitoring Study and pooled results from randomized controlled trials. To evaluate the efficacy and safety of intravenous alteplase (0·9 mg/kg) as thrombolytic therapy within three-hours of onset of acute ischaemic stroke in an Asian population. The 591 patients included were treated at 48 centers in four countries (South Korea, China, India, and Singapore) between 2006 and 2008. Primary outcomes were symptomatic (deterioration in National Institutes of Health Stroke Scale score ≥4 or death within the first 24 h) intracerebral haemorrhage type 2 22-36 h after the thrombolysis and mortality at three-month follow-up. The secondary outcome was functional independence (modified Rankin Scale score 0-2) at three-months. Results were compared with those from Safe Implementation of Thrombolysis in Stroke-Monitoring Study (n = 6483) and pooled results of patients (n = 415) who received intravenous alteplase (0·9 mg/kg) zero- to three-hours from onset of stroke symptoms in four randomized controlled trials (National Institute of Neurological Disorders and Stroke A and B, Altephase Thrombolysis for Acute Noninterventional Therapy in Ischaemic Stroke, and European Cooperative Acute Stroke Study II). Results are presented as Safe Implementation of Thrombolysis in Stroke-Non-European Union World vs. Safe Implementation of Thrombolysis in Stroke-Monitoring Study vs. pooled randomized controlled trials. Median age was 64 vs. 68 vs. 70 years, National Institutes of Health Stroke Scale score at baseline was 12 vs. 12 vs. 13, time from stroke onset to treatment was 130 vs. 140 vs. 135 mins, and females were 36·4% vs. 39·8% vs. 41·2%. Main outcomes (proportion of patients and 95% confidence intervals) were symptomatic intracerebral haemorrhage: 1·9% (1·1-3·3) vs. 1·7% (1·4-2·0) vs. 3·1% (1·8-5·3); mortality: 10·2% (8·0-12·9) vs. 11·3% (10·5-12·1) vs. 16·4% (13·1-20·3); and functional independence: 62·5% (58·5-66·4) vs. 54·8% (53·5-56·0) vs. 50·1% (45·3-54·9) at three-months. Adjusted odds ratio (95% confidence intervals) between Safe Implementation of Thrombolysis in Stroke-Non-European Union World and Safe Implementation of Thrombolysis in Stroke-Monitoring Study, and between Safe Implementation of Thrombolysis in Stroke-Non-European Union World and the pooled trials were 1·83 (0·89-3·77; P = 0·1156) and 0·63 (0·19-2·07; P = 0·4470) for symptomatic intracerebral haemorrhage, 0·90 (0·64-1·25; P = 0·5092) and 0·93 (0·52-1·64; P = 0·7915) for mortality at three-months, and 1·57 (1·25-1·96; P < 0·0001) and 1·35 (0·91-2·00; P = 0·1325) for functional independence. These data demonstrate the safety and efficacy of the standard dose of intravenous alteplase (0·9 mg/kg) in an Asian population, as previously observed in the European population studied in Safe Implementation of Thrombolysis in Stroke-Monitoring Study and the populations in pooled randomized controlled trials, when used in routine clinical practice within three-hours of stroke onset. The findings should encourage wider use of thrombolytic therapy in Asian countries for suitable patients treated in stroke centers. © 2012 The Authors. International Journal of Stroke © 2012 World Stroke Organization.

Exploring the Measurement Properties of the eHealth Literacy Scale (eHEALS) Among Baby Boomers: A Multinational Test of Measurement Invariance.

PubMed

Sudbury-Riley, Lynn; FitzPatrick, Mary; Schulz, Peter J

2017-02-27

The eHealth Literacy Scale (eHEALS) is one of only a few available measurement scales to assess eHealth literacy. Perhaps due to the relative paucity of such measures and the rising importance of eHealth literacy, the eHEALS is increasingly a choice for inclusion in a range of studies across different groups, cultures, and nations. However, despite its growing popularity, questions have been raised over its theoretical foundations, and the factorial validity and multigroup measurement properties of the scale are yet to be investigated fully. The objective of our study was to examine the factorial validity and measurement invariance of the eHEALS among baby boomers (born between 1946 and 1964) in the United States, United Kingdom, and New Zealand who had used the Internet to search for health information in the last 6 months. Online questionnaires collected data from a random sample of baby boomers from the 3 countries of interest. The theoretical underpinning to eHEALS comprises social cognitive theory and self-efficacy theory. Close scrutiny of eHEALS with analysis of these theories suggests a 3-factor structure to be worth investigating, which has never before been explored. Structural equation modeling tested a 3-factor structure based on the theoretical underpinning to eHEALS and investigated multinational measurement invariance of the eHEALS. We collected responses (N=996) to the questionnaires using random samples from the 3 countries. Results suggest that the eHEALS comprises a 3-factor structure with a measurement model that falls within all relevant fit indices (root mean square error of approximation, RMSEA=.041, comparative fit index, CFI=.986). Additionally, the scale demonstrates metric invariance (RMSEA=.040, CFI=.984, ΔCFI=.002) and even scalar invariance (RMSEA=.042, CFI=.978, ΔCFI=.008). To our knowledge, this is the first study to demonstrate multigroup factorial equivalence of the eHEALS, and did so based on data from 3 diverse nations and random samples drawn from an increasingly important cohort. The results give increased confidence to researchers using the scale in a range of eHealth assessment applications from primary care to health promotions. ©Lynn Sudbury-Riley, Mary FitzPatrick, Peter J Schulz. Originally published in the Journal of Medical Internet Research (http://www.jmir.org), 27.02.2017.

Exploring the Measurement Properties of the eHealth Literacy Scale (eHEALS) Among Baby Boomers: A Multinational Test of Measurement Invariance

PubMed Central

2017-01-01

Background The eHealth Literacy Scale (eHEALS) is one of only a few available measurement scales to assess eHealth literacy. Perhaps due to the relative paucity of such measures and the rising importance of eHealth literacy, the eHEALS is increasingly a choice for inclusion in a range of studies across different groups, cultures, and nations. However, despite its growing popularity, questions have been raised over its theoretical foundations, and the factorial validity and multigroup measurement properties of the scale are yet to be investigated fully. Objective The objective of our study was to examine the factorial validity and measurement invariance of the eHEALS among baby boomers (born between 1946 and 1964) in the United States, United Kingdom, and New Zealand who had used the Internet to search for health information in the last 6 months. Methods Online questionnaires collected data from a random sample of baby boomers from the 3 countries of interest. The theoretical underpinning to eHEALS comprises social cognitive theory and self-efficacy theory. Close scrutiny of eHEALS with analysis of these theories suggests a 3-factor structure to be worth investigating, which has never before been explored. Structural equation modeling tested a 3-factor structure based on the theoretical underpinning to eHEALS and investigated multinational measurement invariance of the eHEALS. Results We collected responses (N=996) to the questionnaires using random samples from the 3 countries. Results suggest that the eHEALS comprises a 3-factor structure with a measurement model that falls within all relevant fit indices (root mean square error of approximation, RMSEA=.041, comparative fit index, CFI=.986). Additionally, the scale demonstrates metric invariance (RMSEA=.040, CFI=.984, ΔCFI=.002) and even scalar invariance (RMSEA=.042, CFI=.978, ΔCFI=.008). Conclusions To our knowledge, this is the first study to demonstrate multigroup factorial equivalence of the eHEALS, and did so based on data from 3 diverse nations and random samples drawn from an increasingly important cohort. The results give increased confidence to researchers using the scale in a range of eHealth assessment applications from primary care to health promotions. PMID:28242590

Auto-titrating continuous positive airway pressure treatment for obstructive sleep apnoea after acute quadriplegia (COSAQ): study protocol for a randomized controlled trial.

PubMed

Berlowitz, David J; Ayas, Najib; Barnes, Maree; Brown, Douglas J; Cistulli, Peter A; Geraghty, Tim; Graham, Alison; Lee, Bonsan Bonne; Morris, Meg; O'Donoghue, Fergal; Rochford, Peter D; Ross, Jack; Singhal, Balraj; Spong, Jo; Wadsworth, Brooke; Pierce, Robert J

2013-06-19

Quadriplegia is a severe, catastrophic injury that predominantly affects people early in life, resulting in lifelong physical disability. Obstructive sleep apnoea is a direct consequence of quadriplegia and is associated with neurocognitive deficits, sleepiness and reduced quality of life. The usual treatment for sleep apnoea is nasal continuous positive airway pressure (CPAP); however, this is poorly tolerated in quadriplegia. To encourage patients to use this therapy, we have to demonstrate that the benefits outweigh the inconvenience. We therefore propose a prospective, multinational randomized controlled trial of three months of CPAP for obstructive sleep apnoea after acute quadriplegia. Specialist spinal cord injury centres across Australia, New Zealand, the UK and Canada will recruit medically stable individuals who have sustained a (new) traumatic quadriplegia (complete or incomplete second cervical to first thoracic level lesions). Participants will be screened for obstructive sleep apnoea using full, portable sleep studies. Those with an apnoea hypopnoea index greater than 10 per hour will proceed to an initial three-night trial of CPAP. Those who can tolerate CPAP for at least 4 hours on at least one night of the initial trial will be randomized to either usual care or a 3-month period of auto-titrating CPAP. The primary hypothesis is that nocturnal CPAP will improve neuropsychological functioning more than usual care alone. The secondary hypothesis is that the magnitude of improvement of neuropsychological function will be predicted by the severity of baseline sleepiness measures, sleep fragmentation and sleep apnoea. Neuropsychological tests and full polysomnography will be performed at baseline and 3 months with interim measures of sleepiness and symptoms of autonomic dysfunction measured weekly. Spirometry will be performed monthly. Neuropsychological tests will be administered by blinded assessors. Recruitment commenced in July 2009. The results of this trial will demonstrate the effect of nocturnal CPAP treatment of obstructive sleep apnoea in acute quadriplegia. If CPAP can improve neurocognitive function after injury, it is likely that rehabilitation and subsequent community participation will be substantially improved for this group of predominantly young and severely physically disabled people. Australian New Zealand Clinical Trial Registry ACTRN12605000799651.

Assuaging Nuclear Energy Risks: The Angarsk International Uranium Enrichment Center

NASA Astrophysics Data System (ADS)

Myers, Astasia

2011-06-01

The recent nuclear renaissance has motivated many countries, especially developing nations, to plan and build nuclear power reactors. However, domestic low enriched uranium demands may trigger nations to construct indigenous enrichment facilities, which could be redirected to fabricate high enriched uranium for nuclear weapons. The potential advantages of establishing multinational uranium enrichment sites are numerous including increased low enrichment uranium access with decreased nuclear proliferation risks. While multinational nuclear initiatives have been discussed, Russia is the first nation to actualize this concept with their Angarsk International Uranium Enrichment Center (IUEC). This paper provides an overview of the historical and modern context of the multinational nuclear fuel cycle as well as the evolution of Russia's IUEC, which exemplifies how international fuel cycle cooperation is an alternative to domestic facilities.

Reducing Proliferation Rick Through Multinational Fuel Cycle Facilities

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

Amanda Rynes

2010-11-01

With the prospect of rapid expansion of the nuclear energy industry and the ongoing concern over weapons proliferation, there is a growing need for a viable alternative to traditional nation-based fuel production facilities. While some in the international community remain apprehensive, the advantages of multinational fuel cycle facilities are becoming increasingly apparent, with states on both sides of the supply chain able to garner the security and financial benefits of such facilities. Proliferation risk is minimized by eliminating the need of states to establish indigenous fuel production capabilities and the concept's structure provides an additional internationally monitored barrier against themore » misuse or diversion of nuclear materials. This article gives a brief description of the arguments for and against the implementation of a complete multinational fuel cycle.« less

An operational computer program to control Self Defense Surface Missile System operations

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

Roe, C.L.

1991-12-01

An account is given of the system architecture and operational protocols of the NATO Seasparrow Surface Missile System (NSSMS) Operational Computer Program (OCP) which has been developed, and is being deployed multinationally, to respond against antiship missiles. Flowcharts are presented for the target detection and tracking, control, and engagement phases of the Self Defense Surface Missile System that is controlled by the OCP. USN and other NATO vessels will carry the NSSMS well into the next century; the OCP presently described will be deployed in the course of 1992 to enhance the self-defense capabilities of the NSSMS-equipped fleet. 8 refs.

A multinational case-control study on childhood brain tumours, anthropogenic factors, birth characteristics and prenatal exposures: A validation of interview data.

PubMed

Vienneau, Danielle; Infanger, Denis; Feychting, Maria; Schüz, Joachim; Schmidt, Lisbeth Samsø; Poulsen, Aslak Harbo; Tettamanti, Giorgio; Klæboe, Lars; Kuehni, Claudia E; Tynes, Tore; Von der Weid, Nicolas; Lannering, Birgitta; Röösli, Martin

2016-02-01

Little is known about the aetiology of childhood brain tumours. We investigated anthropometric factors (birth weight, length, maternal age), birth characteristics (e.g. vacuum extraction, preterm delivery, birth order) and exposures during pregnancy (e.g. maternal: smoking, working, dietary supplement intake) in relation to risk of brain tumour diagnosis among 7-19 year olds. The multinational case-control study in Denmark, Sweden, Norway and Switzerland (CEFALO) included interviews with 352 (participation rate=83.2%) eligible cases and 646 (71.1%) population-based controls. Interview data were complemented with data from birth registries and validated by assessing agreement (Cohen's Kappa). We used conditional logistic regression models matched on age, sex and geographical region (adjusted for maternal age and parental education) to explore associations between birth factors and childhood brain tumour risk. Agreement between interview and birth registry data ranged from moderate (Kappa=0.54; worked during pregnancy) to almost perfect (Kappa=0.98; birth weight). Neither anthropogenic factors nor birth characteristics were associated with childhood brain tumour risk. Maternal vitamin intake during pregnancy was indicative of a protective effect (OR 0.75, 95%-CI: 0.56-1.01). No association was seen for maternal smoking during pregnancy or working during pregnancy. We found little evidence that the considered birth factors were related to brain tumour risk among children and adolescents. Copyright © 2015 Elsevier Ltd. All rights reserved.

Multinational Operations and Small Nations: Implications and Considerations in Lithuanian Perspective

DTIC Science & Technology

2004-06-17

foreign policy (Putnam 2003). Additionally, Kenneth N. Waltz in his book, Theory of International Politics, asserts that states, according to the strength...is another important factor in neorealist analysis. Kenneth N. Waltz in his book, Man, the State and War: A Theoretical Analysis, argues that a state...common operational picture, as well as flexible and secure command and control and sensors and shooters , has slowed the US military’s ability to operate

Emissions trading: principles and practice. 2nd

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

Tietenberg, T.H.

2006-02-15

The author demonstrates how emissions trading became an attractive alternative to command-and-control policies that would have required the EPA to disallow the opening of new plants in the middle of the recession-burdened 1970s. His examination of the evolution of this system includes, among other applications, the largest multinational trading system ever conceived, the European Union's Greenhouse Gas Emission Trading Scheme (EUETG), and the use of emissions trading in the Kyoto Protocol.

Efficacy and safety of extended-release oxcarbazepine (Oxtellar XR™) as adjunctive therapy in patients with refractory partial-onset seizures: a randomized controlled trial

PubMed Central

French, JA; Baroldi, P; Brittain, ST; Johnson, JK

2014-01-01

Objective To evaluate the efficacy, tolerability, and safety of once-daily 1200 mg and 2400 mg SPN-804 (Oxtellar XR™, Supernus Pharmaceuticals), an extended-release tablet formulation of oxcarbazepine (OXC), added to 1-3 concomitant antiepileptic drugs (AEDs) in adults with refractory partial-onset seizures, with or without secondary generalization. Methods The Prospective, Randomized Study of OXC XR in Subjects with Partial Epilepsy Refractory (PROSPER) study was a multinational, randomized, double-blind, parallel-group Phase 3 study. The primary efficacy endpoint was median percent reduction from baseline in monthly (28-day) seizure frequency for the 16-week double-blind treatment period in the intent-to-treat (ITT) population with analyzable seizure data. Other efficacy analyses included proportion of patients with ≥ 50% seizure reduction, proportion of patients seizure free, and the relationship between clinical response and plasma concentration. Results Median percent reduction was -28.7% for placebo, −38.2% (P = 0.08 vs placebo) for once-daily SPN-804 1200 mg, and −42.9% (P = 0.003) for SPN-804 2400 mg. Responder rates were 28.1%, 36.1% (P = 0.08), and 40.7% (P = 0.02); 16-week seizure-free rates in a pragmatic ITT analysis were 3.3%, 4.9% (P = 0.59), and 11.4% (P = 0.008), respectively. When data were analyzed separately for study site clusters, a post hoc analysis demonstrated that both SPN-804 dosages were significantly superior to placebo in median percent seizure reduction (placebo: −13.3%; 1200 mg: −34.5%, P = 0.02; 2400 mg: −52.7%, P = 0.006) in the North American study site cluster. A concentration–response analysis also supported a clinically meaningful effect for 1200 mg. Adverse event types reflected the drug's established profile. Adverse event frequency was consistent with a pharmacokinetic profile in which SPN-804 produces lower peak plasma concentrations vs immediate-release OXC. Once-daily dosing was not associated with any new safety signals. Conclusions Adjunctive once-daily SPN-804 improved seizure control in patients with inadequately controlled partial-onset seizures. Adverse event occurrence and discontinuations due to adverse events suggest improved tolerability vs previously published data with immediate-release OXC. PMID:24359313

Open-Label, Randomized Study of Transition From Tacrolimus to Sirolimus Immunosuppression in Renal Allograft Recipients

PubMed Central

Tedesco-Silva, Helio; Peddi, V. Ram; Sánchez-Fructuoso, Ana; Marder, Brad A.; Russ, Graeme R.; Diekmann, Fritz; Flynn, Alison; Hahn, Carolyn M.; Li, Huihua; Tortorici, Michael A.; Schulman, Seth L.

2016-01-01

Background Calcineurin inhibitor–associated nephrotoxicity and other adverse events have prompted efforts to minimize/eliminate calcineurin inhibitor use in kidney transplant recipients. Methods This open-label, randomized, multinational study evaluated the effect of planned transition from tacrolimus to sirolimus on kidney function in renal allograft recipients. Patients received tacrolimus-based immunosuppression and then were randomized 3 to 5 months posttransplantation to transition to sirolimus or continue tacrolimus. The primary end point was percentage of patients with 5 mL/min per 1.73 m2 or greater improvement in estimated glomerular filtration rate from randomization to month 24. Results The on-therapy population included 195 patients (sirolimus, 86; tacrolimus, 109). No between-group difference was noted in percentage of patients with 5 mL/min per 1.73 m2 or greater estimated glomerular filtration rate improvement (sirolimus, 34%; tacrolimus, 42%; P = 0.239) at month 24. Sirolimus patients had higher rates of biopsy-confirmed acute rejection (8% vs 2%; P = 0.02), treatment discontinuation attributed to adverse events (21% vs 3%; P < 0.001), and lower rates of squamous cell carcinoma of the skin (0% vs 5%; P = 0.012). Conclusions Our findings suggest that renal function improvement at 24 months is similar for patients with early conversion to sirolimus after kidney transplantation versus those remaining on tacrolimus. PMID:27500260

Mass communication and cultural identity: the unresolved issue of national sovereignty and cultural autonomy in the wake of new communication technologies.

PubMed

Uche, L U

1988-01-01

The trend in modern mass communication appears to be toward the imposition of the cultural, economic, and political values of the societies with the most advanced communication and information technologies and media sources. The consequence of this reality is that the cultural values, national aspirations, economic needs, and political independence of developing countries are not taken into consideration. Thus, the national interests of African states make it imperative for them to carefully evaluate, assess, and examine the development of their present media structures and ownership patterns. If the mass media is privatized, their owners serve as mouthpieces for multinational corporations. This phenomenon can severely undermine African goals of self-sufficiency in food production and industrialization, political stability that guarantees territorial integrity, and preservation of the African culture. It is imperative that African governments do not allow big multinationals to take over the molding and control of public opinion. Although modern systems of communication are exceedingly expensive and sophisticated, ways must be found to make the media public utilities.

Impact of the European Clinical Trials Directive on academic clinical research.

PubMed

Baeyens, A J

2004-01-01

With the adoption of the Clinical Trials Directive it was Europe's intention to make the performance of multi-national clinical trials in Europe easier through the harmonization of the regulatory procedures. As the Directive was mainly conceived to facilitate the performance of multi-national clinical trials to develop new drugs, it is to be determined to what extent academic clinical trials will be concerned by the Directive and more importantly what will be its impact on daily academic clinical research. Contrary to several national regulations the scope of the Directive is very large only excluding non-interventional trials. This implies that most of the academic clinical trials will be concerned by the Directive. Besides the handling of the regulatory procedures in the different countries, issues related to insurance, labeling requirements and provision of the investigational medical products will expose the academic sponsor to additional administrative and financial challenges that will have to be handled appropriately, as the academic sponsors will be controlled by Inspectors regarding their compliance with the new regulations to come.

The Mission Partner Environment: Challenges To Multinational Information Sharing

DTIC Science & Technology

2016-02-15

Harvey , Royal Air Force 15 February 2016 DISTRIBUTION A. Approved for public release: distribution unlimited. ii Disclaimer The views expressed...troops, with non-U.S. commanders in charge of vast areas of inhospitable geography . The enormous size and scope of this mission created incredibly...between people and organizations separated by wide geography is the requirement for a persistent and durable means for multinational communication and

How China Could Affect the Future of U.S. Defense Corporations

DTIC Science & Technology

2010-12-01

of Jonathan Galloway , who addressees among many things, the global implications of DMNCs by differentiating the driving mechanisms for these... Galloway , “The Military-Industrial Linkages of U.S.-Based Multinational Corporations,” International Studies Quarterly 16, no. 4, Multinational...individual percentages.56 Galloway states “it stands to reason that their managements will be interested in preserving the dynamic equilibrium between

Implications for the U.S. of Anglo-French Defense Cooperation

DTIC Science & Technology

2012-04-30

multinational European military development projects are viewed with scepticism in the UK, the Anglo- French arrangement could strengthen the prospects...multinational European military development projects are viewed with scepticism in the UK, the Anglo- French arrangement could strengthen the prospects for...programme. The UK also dropped out of the Horizon Common New Generation Frigate project , which included France and Italy (Antill, 2011). Continued

The Promotion of Bottle Feeding by Multinational Corporations: How Advertising and the Health Professions Have Contributed. Cornell International Nutritioon Monograph Series, Number 2 (1975).

ERIC Educational Resources Information Center

Greiner, Ted; Latham, Michael C., Ed.

This report investigates the ways bottle feeding of infants is promoted by multinational corporations. Data were obtained from the following: (1) a survey of available infant food advertising in newspapers and magazines from developing countries; (2) a study of some interrelationships between the health professions and infant food companies,…

The end of corporate imperialism.

PubMed

Prahalad, C K; Lieberthal, Kenneth

2003-08-01

As they search for growth, multinational corporations will have no choice but to compete in the big emerging markets of China, India, Indonesia, and Brazil. But while it is still common to question how such corporations will change life in those markets, Western executives would be smart to turn the question around and ask how multinationals themselves will be transformed by these markets. To be successful, MNCs will have to rethink every element of their business models, the authors assert in this seminal HBR article from 1998. During the first wave of market entry in the 1980s, multinationals operated with what might be termed an imperialist mind-set, assuming that the emerging markets would merely be new markets for their old products. But this mind-set limited their success: What is truly big and emerging in countries like China and India is a new consumer base comprising hundreds of millions of people. To tap into this huge opportunity, MNCs need to ask themselves five basic questions: Who is in the emerging middle class in these countries? How do the distribution networks operate? What mix of local and global leadership do you need to foster business opportunities? Should you adopt a consistent strategy for all of your business units within one country? Should you take on local partners? The transformation that multinational corporations must undergo is not cosmetic--simply developing greater sensitivity to local cultures will not do the trick, the authors say. To compete in the big emerging markets, multinationals must reconfigure their resources, rethink their cost structures, redesign their product development processes, and challenge their assumptions about who their top-level managers should be.

A randomized trial comparing concise and standard consent forms in the START trial

PubMed Central

Touloumi, Giota; Walker, A. Sarah; Smolskis, Mary; Sharma, Shweta; Babiker, Abdel G.; Pantazis, Nikos; Tavel, Jorge; Florence, Eric; Sanchez, Adriana; Hudson, Fleur; Papadopoulos, Antonios; Emanuel, Ezekiel; Clewett, Megan; Munroe, David; Denning, Eileen

2017-01-01

Background Improving the effectiveness and efficiency of research informed consent is a high priority. Some express concern about longer, more complex, written consent forms creating barriers to participant understanding. A recent meta-analysis concluded that randomized comparisons were needed. Methods We conducted a cluster-randomized non-inferiority comparison of a standard versus concise consent form within a multinational trial studying the timing of starting antiretroviral therapy in HIV+ adults (START). Interested sites were randomized to standard or concise consent forms for all individuals signing START consent. Participants completed a survey measuring comprehension of study information and satisfaction with the consent process. Site personnel reported usual site consent practices. The primary outcome was comprehension of the purpose of randomization (pre-specified 7.5% non-inferiority margin). Results 77 sites (2429 participants) were randomly allocated to use standard consent and 77 sites (2000 participants) concise consent, for an evaluable cohort of 4229. Site and participant characteristics were similar for the two groups. The concise consent was non-inferior to the standard consent on comprehension of randomization (80.2% versus 82%, site adjusted difference: 0.75% (95% CI -3.8%, +5.2%)); and the two groups did not differ significantly on total comprehension score, satisfaction, or voluntariness (p>0.1). Certain independent factors, such as education, influenced comprehension and satisfaction but not differences between consent groups. Conclusions An easier to read, more concise consent form neither hindered nor improved comprehension of study information nor satisfaction with the consent process among a large number of participants. This supports continued efforts to make consent forms more efficient. Trial registration Informed consent substudy was registered as part of START study in clinicaltrials.gov #NCT00867048, and EudraCT # 2008-006439-12 PMID:28445471

Mapping R&D within Multinational Networks: Evidence from the Electronics Industry

NASA Astrophysics Data System (ADS)

Urze, Paula; Manatos, Maria João

Based on the final results of the R&D.COM - Local R&D COMpetencies within Global Value Chains project, this paper aims at mapping the trajectories of delocalised R&D units within a multinational’s global strategy and designing the knowledge flows within the global value chain. This analysis was performed using typologies proposed in the theoretical framework, which help us to have an overview of the network. The methodology is grounded on one extended case study that involves a local R&D unit (Portugal), a foreign R&D unit (Netherlands) and the headquarters (Norway) - developed on a multinational from the electronics industry. This case is an example of a multinational company where R&D is developed mainly in the headquarters but it is also delocalised to some subsidiaries with a certain level of autonomy.

Prevention of influenza at Hajj: applications for mass gatherings.

PubMed

Haworth, Elizabeth; Barasheed, Osamah; Memish, Ziad A; Rashid, Harunor; Booy, Robert

2013-06-01

Outbreaks of infectious diseases that spread via respiratory route, e.g. influenza, are common amongst Hajj congregation in Mecca, Saudi Arabia. The Saudi Arabian authority successfully organized the Hajj 2009 amidst fear of pandemic influenza. While severe influenza A(H1N1)pdm09 was rare, the true burden of pandemic influenza at Hajj that year remains speculative. In this article we review the latest evidence on influenza control and discuss our experience of influenza and its prevention at Hajj and possible application to other mass gatherings. Depending on study design the attack rate of seasonal influenza at Hajj has ranged from 6% in polymerase chain reaction or culture confirmed studies to 38% in serological surveillance. No significant effect of influenza vaccine or the use of personal protective measures against influenza has been established from observational studies, although the uptake of the vaccine and adherence to face masks and hand hygiene has been low. In all, there is a relatively poor evidence base for control of influenza. Until better evidence is obtained, vaccination coupled with rapid antiviral treatment of symptomatic individuals remains the mainstay of prevention at Hajj and other mass gatherings. Hajj pilgrimage provides a unique opportunity to test the effectiveness of various preventive measures that require a large sample size, such as testing the efficacy of plain surgical masks against laboratory-confirmed influenza. After successful completion of a pilot trial conducted among Australian pilgrims at the 2011 Hajj, a large multinational cluster randomized controlled trial is being planned. This will require effective international collaboration.

Decisive Action Training Environment at the Joint Multinational Readiness Center, Volume 3: Multinational Interoperability

DTIC Science & Technology

2016-09-01

training in the decisive action training environment, with rotations routinely featuring several thousand participants from many nations and operating in...teams work with exercise participants before they arrive at the training center. The goal is to ensure all formations understand — and are able to...capabilities, location, and extensive experience working with NATO and partner countries, the JMTC is uniquely positioned to implement NATO training

Competence and Human Resource Development in Multinational Companies in Three European Union Member States: A Comparative Analysis between Austria, the Netherlands and the United Kingdom. CEDEFOP Panorama Series.

ERIC Educational Resources Information Center

Markowitsch, Jorg; Kollinger, Iris; Warmerdam, John; Moerel, Hans; Konrad, John; Burell, Catherine; Guile, David

A comparative analysis of human resources development and management in the subsidiaries of three multinational companies (Xerox, Glaxo Wellcome, and AXA Nordstern Colonia) was conducted in these three European Union (EU) member states: Austria, the United Kingdom, and the Netherlands. Case studies were used, focusing on competence needs and…

Multinational Experiment 7. Protecting Access to Space: Presentation to Senior Leaders

DTIC Science & Technology

2013-07-08

Multinational Experiment 7: Outcome 3: Space Access Briefing to SLS 5a. CONTRACT NUMBER 5b. GRANT NUMBER 5c. PROGRAM ELEMENT NUMBER 6. AUTHOR(S) 5d...operations Consequence management Ship status during search & rescue Tele-medicine Broadband internet TV signal distribution Satellite radio Rural...military-usage • Significant economic & societal consequences Access to space at risk • Current approach unsustainable • Broad range of threats

National Security Implications of Transnational Economic Activity

DTIC Science & Technology

1993-04-01

ABSTRACT SECURITY CLASSIFICATION rUNCLASSIFIED/UNLIMITED El SAME AS RPT. O DTIC USERS Unclassified 22a. NAME OF RESPONSIBLE INDIVIDUAL 22b. TELEPHONE...Activity This paper discusses the impact of regional trading arrangements (RTA’s), multinational corporations (MNC’s), and transnational financial activity...multinational corporation investment and taxation. o The U.S. must strengthen its national economy in order to be a world class player in transnational

Conducting a multicentre and multinational qualitative study on patient transitions.

PubMed

Johnson, Julie K; Barach, Paul; Vernooij-Dassen, Myrra

2012-12-01

A multicentre, multinational research study requires careful planning and coordination to accomplish the aims of the study and to ensure systematic and rigorous examination of all project methods and data collected. The aim of this paper is to describe the approach we used during the HANDOVER Project to develop a multicentre, multinational research project for studying transitions of patient care while creating a community of practice for the researchers. We highlight the process used to assure the quality of a multicentre qualitative study and to create a codebook for data analysis as examples of attending to the community of practice while conducting rigorous qualitative research. Essential elements for the success of this multinational, multilanguage research project included recruiting a strong research team, explicit planning for decision-making processes to be used throughout the project, acknowledging the differences among the study settings and planning the protocols to capitalise upon those differences. Although not commonly discussed in reports of large research projects, there is an underlying, concurrent stream of activities to develop a cohesive team that trusts and respects one another's skills and that engage independent researchers in a group process that contributes to achieving study goals. We discuss other lessons learned and offer recommendations for other teams planning multicentre research.

Outpatient treatment of alcohol use disorders among subjects 60+ years: design of a randomized clinical trial conducted in three countries (Elderly Study).

PubMed

Andersen, Kjeld; Bogenschutz, Michael P; Bühringer, Gerhard; Behrendt, Silke; Bilberg, Randi; Braun, Barbara; Ekstrøm, Claus Thorn; Forcehimes, Alyssa; Lizarraga, Christine; Moyers, Theresa B; Nielsen, Anette Søgaard

2015-11-14

The proportion of 60+ years with excessive alcohol intake varies in western countries between 6-16 % among men and 2-7 % among women. Specific events related to aging (e.g. loss of job, physical and mental capacity, or spouse) may contribute to onset or continuation of alcohol use disorders (AUD). We present the rationale and design of a multisite, multinational AUD treatment study for subjects aged 60+ years. 1,000 subjects seeking treatment for AUD according to DSM-5 in outpatient clinics in Denmark, Germany, and New Mexico (USA) are invited to participate in a RCT. Participants are randomly assigned to four sessions of Motivational Enhancement Treatment (MET) or to MET plus an add-on with eight sessions based on the Community Reinforcement Approach (CRA), which include a new module targeting specific problems of older adults. A series of assessment instruments is applied, including the Form-90, Alcohol Dependence Scale, Penn Alcohol Craving Scale, Brief Symptom Inventory and WHO Quality of Life. Enrolment will be completed by April 2016 and data collection by April 2017. The primary outcome is the proportion in each group who are abstinent or have a controlled use of alcohol six months after treatment initiation. Controlled use is defined as maximum blood alcohol content not exceeding 0.05 % during the last month. Total abstinence is a secondary outcome, together with quality of life andcompliance with treatment. The study will provide new knowledge about brief treatment of AUD for older subjects. As the treatment is manualized and applied in routine treatment facilities, barriers for implementation in the health care system are relatively low. Finally, as the study is being conducted in three different countries it will also provide significant insight into the possible interaction of service system differences and related patient characteristics in predictionof treatment outcome. Clinical Trials.gov NCT02084173 , March 7, 2014.

Insulin lispro low mixture twice daily versus basal insulin glargine once daily and prandial insulin lispro once daily in patients with type 2 diabetes requiring insulin intensification: a randomized phase IV trial.

PubMed

Tinahones, F J; Gross, J L; Onaca, A; Cleall, S; Rodríguez, A

2014-10-01

To compare the efficacy and safety of two insulin intensification strategies in patients with type 2 diabetes inadequately controlled on basal insulin glargine with metformin and/or pioglitazone. A multinational, randomized, open-label trial that compared insulin lispro low mixture (LM25; n = 236) twice daily with a basal-prandial regimen of insulin glargine once daily and insulin lispro once daily (IGL; n = 240) over 24 weeks in patients with HbA1c 7.5-10.5% and fasting plasma glucose ≤ 6.7 mmol/l. The primary objective was to assess non-inferiority [per-protocol (PP) population], and then superiority [intention-to-treat (ITT) population], of LM25 versus IGL according to change in HbA1c after 24 weeks (non-inferiority margin 0.4%, two-sided significance level 0.05). Estimated change [least squares (LS) mean (95% CI)] in HbA1c after 24 weeks: -1.30 (-1.44, -1.16)% with LM25 and -1.08 (-1.22, -0.94)% with IGL. Non-inferiority was shown [LS mean (95% CI) HbA1c treatment difference -0.21 (-0.38, -0.04) (PP population)]; gated superiority assessment showed a statistically significant advantage for LM25 (p = 0.010; ITT population). Mean blood glucose, glycaemic variability, overall tolerability and hypoglycaemic episodes per patient-year did not show significant differences between treatments during the study. In patients with type 2 diabetes inadequately controlled on once-daily basal insulin glargine and metformin and/or pioglitazone, intensification with LM25 was superior to a basal-prandial approach in terms of reduction in HbA1c after 24 weeks and did not increase hypoglycaemia episodes. © 2014 The Authors. Diabetes, Obesity and Metabolism published by JohnWiley & Sons Ltd.

Modelling of occupational respirable crystalline silica exposure for quantitative exposure assessment in community-based case-control studies.

PubMed

Peters, Susan; Vermeulen, Roel; Portengen, Lützen; Olsson, Ann; Kendzia, Benjamin; Vincent, Raymond; Savary, Barbara; Lavoué, Jérôme; Cavallo, Domenico; Cattaneo, Andrea; Mirabelli, Dario; Plato, Nils; Fevotte, Joelle; Pesch, Beate; Brüning, Thomas; Straif, Kurt; Kromhout, Hans

2011-11-01

We describe an empirical model for exposure to respirable crystalline silica (RCS) to create a quantitative job-exposure matrix (JEM) for community-based studies. Personal measurements of exposure to RCS from Europe and Canada were obtained for exposure modelling. A mixed-effects model was elaborated, with region/country and job titles as random effect terms. The fixed effect terms included year of measurement, measurement strategy (representative or worst-case), sampling duration (minutes) and a priori exposure intensity rating for each job from an independently developed JEM (none, low, high). 23,640 personal RCS exposure measurements, covering a time period from 1976 to 2009, were available for modelling. The model indicated an overall downward time trend in RCS exposure levels of -6% per year. Exposure levels were higher in the UK and Canada, and lower in Northern Europe and Germany. Worst-case sampling was associated with higher reported exposure levels and an increase in sampling duration was associated with lower reported exposure levels. Highest predicted RCS exposure levels in the reference year (1998) were for chimney bricklayers (geometric mean 0.11 mg m(-3)), monument carvers and other stone cutters and carvers (0.10 mg m(-3)). The resulting model enables us to predict time-, job-, and region/country-specific exposure levels of RCS. These predictions will be used in the SYNERGY study, an ongoing pooled multinational community-based case-control study on lung cancer.

Design and analysis issues for economic analysis alongside clinical trials.

PubMed

Marshall, Deborah A; Hux, Margaret

2009-07-01

Clinical trials can offer a valuable and efficient opportunity to collect the health resource use and outcomes data for economic evaluation. However, economic and clinical studies differ fundamentally in the question they seek to answer. The design and analysis of trial-based cost-effectiveness studies require special consideration, which are reviewed in this article. Traditional randomized controlled trials, using an experimental design with a controlled protocol, are designed to measure safety and efficacy for product registration. Cost-effectiveness analysis seeks to measure effectiveness in the context of routine clinical practice, and requires collection of health care resources to allow estimation of cost over an equal timeframe for each treatment alternative. In assessing suitability of a trial for economic data collection, the comparator treatment and other protocol factors need to reflect current clinical practice and the trial follow-up must be sufficiently long to capture important costs and effects. The broadest available population and a measure of effectiveness reflecting important benefits for patients are preferred for economic analyses. Special analytical issues include dealing with missing and censored cost data, assessing uncertainty of the incremental cost-effectiveness ratio, and accounting for the underlying heterogeneity in patient subgroups. Careful consideration also needs to be given to data from multinational studies since practice patterns can differ across countries. Although clinical trials can be an efficient opportunity to collect data for economic evaluation, careful consideration of the suitability of the study design, and appropriate analytical methods must be applied to obtain rigorous results.

A novel study design for antibiotic trials in acute exacerbations of COPD: MAESTRAL methodology

PubMed Central

Wilson, Robert; Anzueto, Antonio; Miravitlles, Marc; Arvis, Pierre; Faragó, Geneviève; Haverstock, Daniel; Trajanovic, Mila; Sethi, Sanjay

2011-01-01

Antibiotics, along with oral corticosteroids, are standard treatments for acute exacerbations of chronic obstructive pulmonary disease (AECOPD). The ultimate aims of treatment are to minimize the impact of the current exacerbation, and by ensuring complete resolution, reduce the risk of relapse. In the absence of superiority studies of antibiotics in AECOPD, evidence of the relative efficacy of different drugs is lacking, and so it is difficult for physicians to select the most effective antibiotic. This paper describes the protocol and rationale for MAESTRAL (moxifloxacin in AECBs [acute exacerbation of chronic bronchitis] trial; www.clinicaltrials.gov: NCT00656747), one of the first antibiotic comparator trials designed to show superiority of one antibiotic over another in AECOPD. It is a prospective, multinational, multicenter, randomized, double-blind controlled study of moxifloxacin (400 mg PO [ per os] once daily for 5 days) vs amoxicillin/clavulanic acid (875/125 mg PO twice daily for 7 days) in outpatients with COPD and chronic bronchitis suffering from an exacerbation. MAESTRAL uses an innovative primary endpoint of clinical failure: the requirement for additional or alternate treatment for the exacerbation at 8 weeks after the end of antibiotic therapy, powered for superiority. Patients enrolled are those at high-risk of treatment failure, and all are experiencing an Anthonisen type I exacerbation. Patients are stratified according to oral corticosteroid use to control their effect across antibiotic treatment arms. Secondary endpoints include quality of life, symptom assessments and health care resource use. PMID:21760724

Fish Oil and Post-Operative Atrial Fibrillation – Results of the Omega-3 Fatty Acids for Prevention of Post-Operative Atrial Fibrillation (OPERA) Trial

PubMed Central

Mozaffarian, Dariush; Marchioli, Roberto; Macchia, Alejandro; Silletta, Maria G.; Ferrazzi, Paolo; Gardner, Timothy J.; Latini, Roberto; Libby, Peter; Lombardi, Federico; O’Gara, Patrick T.; Page, Richard L.; Tavazzi, Luigi; Tognoni, Gianni

2013-01-01

Context Post-operative atrial fibrillation/flutter (AF) is one of the most common complications of cardiac surgery and significantly increases morbidity and healthcare utilization. A few small trials have evaluated whether long-chain n-3-polyunsaturated fatty acids (PUFA) reduce post-op AF, with mixed results. Objective To determine whether peri-operative n-3-PUFA supplementation reduces post-op AF. Design Randomized, double-blind, placebo-controlled, multinational, clinical trial. Patients A total of 1,516 patients scheduled for cardiac surgery across 28 centers in the US, Italy, and Argentina, enrolled between Aug 2010 and Jun 2012. Inclusion criteria were broad; the main exclusions were regular use of fish oil or absence of sinus rhythm at enrollment. Forty-eight percent of screened patients and 94% of eligible patients were enrolled. Intervention Patients were randomized to receive fish oil (1 g capsules containing ≥840 mg n-3-PUFA as ethyl esters) or placebo, with pre-operative loading of 10g over 3-5 days (or 8g over 2 days) followed post-operatively by 2g/d until hospital discharge or post-op day10, whichever first. Main Outcome Measures The primary endpoint was occurrence of post-op AF >30 sec. We also evaluated post-op AF lasting >1hr, resulting in symptoms, or treated with cardioversion; other secondary post-op AF endpoints; other tachyarrhythmias; hospital utilization; and major adverse cardiovascular events, 30-day mortality, bleeding, and other adverse events. All endpoints and analyses plans were prespecified. Results At enrollment, mean±SD age was 64±13 years, 72.2% were male, and 51.8% had planned valvular surgery. The primary endpoint occurred in 233 (30.7%) and 227 (30.0%) patients assigned to placebo and n-3-PUFA, respectively (OR=0.96, 95%CI=0.77-1.20; P=0.74). None of the secondary endpoints were significantly different, including post-op AF that was sustained, symptomatic, or treated (n=231 [30.5%] vs. n=224 [29.6%], P=0.70) or number of post-op AF episodes per patient (1 episode: n=220 [29.0%] vs. n=217 [28.6%]; 2 episodes: n=156 [20.6%] vs. n=157 [20.7%]; 3+ episodes: n=18 [2.4%] vs. n=21 [2.8%]; P=0.73). n-3-PUFA was generally well-tolerated, with no evidence for increased risk of bleeding or serious adverse events. Conclusions In this large multinational trial among patients undergoing cardiac surgery, peri-operative supplementation with n-3-PUFA, compared to placebo, did not reduce the risk of post-operative AF. PMID:23128104

Evaluation of a novel antiplatelet agent for secondary prevention in patients with a history of atherosclerotic disease: design and rationale for the Thrombin-Receptor Antagonist in Secondary Prevention of Atherothrombotic Ischemic Events (TRA 2 degrees P)-TIMI 50 trial.

PubMed

Morrow, David A; Scirica, Benjamin M; Fox, Keith A A; Berman, Gail; Strony, John; Veltri, Enrico; Bonaca, Marc P; Fish, Polly; McCabe, Carolyn H; Braunwald, Eugene

2009-09-01

Thrombin potently activates platelets via interaction with the protease-activated receptor 1. SCH 530348 is a novel antiplatelet agent that selectively inhibits the cellular actions of thrombin via antagonism of the protease-activated receptor 1. Because SCH 530348 does not interfere with other pathways for hemostasis, it is possible that SCH 530348 reduces thrombosis with less increase in bleeding than do other potent antiplatelet agents. TRA 2 degrees P-TIMI 50 is a phase III, randomized, double-blind, placebo-controlled, multinational clinical trial designed to evaluate the efficacy and safety of SCH 530348 during long-term treatment of patients with established atherosclerotic disease receiving standard therapy (up to 27,000). Eligible patients with a history of myocardial infarction, ischemic stroke, or peripheral arterial disease are randomized 1:1 to SCH 530348 2.5 mg daily or matched placebo until the end of study. Randomization is stratified by the qualifying disease and planned use of a thienopyridine. The primary end point is the composite of cardiovascular death, myocardial infarction, stroke, or urgent coronary revascularization. The major secondary end point is the composite of cardiovascular death, myocardial infarction, or stroke. The evaluation of long-term safety includes bleeding defined by the GUSTO and TIMI criteria. Recruitment began in September 2007. The trial will continue until 2,279 primary end points and 1,400 secondary end points are recorded with expected completion in 36 to 44 months from first enrollment. TRA 2 degrees P-TIMI 50 is evaluating whether a new approach to platelet inhibition via interruption of thrombin-mediated platelet activation reduces major cardiovascular events with a favorable safety profile in patients with established atherosclerosis.

Fixation using alternative implants for the treatment of hip fractures (FAITH): design and rationale for a multi-centre randomized trial comparing sliding hip screws and cancellous screws on revision surgery rates and quality of life in the treatment of femoral neck fractures

PubMed Central

2014-01-01

Background Hip fractures are a common type of fragility fracture that afflict 293,000 Americans (over 5,000 per week) and 35,000 Canadians (over 670 per week) annually. Despite the large population impact the optimal fixation technique for low energy femoral neck fractures remains controversial. The primary objective of the FAITH study is to assess the impact of cancellous screw fixation versus sliding hip screws on rates of revision surgery at 24 months in individuals with femoral neck fractures. The secondary objective is to determine the impact on health-related quality of life, functional outcomes, health state utilities, fracture healing, mortality and fracture-related adverse events. Methods/Design FAITH is a multi-centre, multi-national randomized controlled trial utilizing minimization to determine patient allocation. Surgeons in North America, Europe, Australia, and Asia will recruit a total of at least 1,000 patients with low-energy femoral neck fractures. Using central randomization, patients will be allocated to receive surgical treatment with cancellous screws or a sliding hip screw. Patient outcomes will be assessed at one week (baseline), 10 weeks, 6, 12, 18, and 24 months post initial fixation. We will independently adjudicate revision surgery and complications within 24 months of the initial fixation. Outcome analysis will be performed using a Cox proportional hazards model and likelihood ratio test. Discussion This study represents major international efforts to definitively resolve the treatment of low-energy femoral neck fractures. This trial will not only change current Orthopaedic practice, but will also set a benchmark for the conduct of future Orthopaedic trials. Trial registration The FAITH trial is registered at ClinicalTrials.gov (Identifier NCT00761813). PMID:24965132

The MOBI-Kids Study Protocol: Challenges in Assessing Childhood and Adolescent Exposure to Electromagnetic Fields from Wireless Telecommunication Technologies and Possible Association with Brain Tumor Risk

PubMed Central

Sadetzki, Siegal; Langer, Chelsea Eastman; Bruchim, Revital; Kundi, Michael; Merletti, Franco; Vermeulen, Roel; Kromhout, Hans; Lee, Ae-Kyoung; Maslanyj, Myron; Sim, Malcolm R.; Taki, Masao; Wiart, Joe; Armstrong, Bruce; Milne, Elizabeth; Benke, Geza; Schattner, Rosa; Hutter, Hans-Peter; Woehrer, Adelheid; Krewski, Daniel; Mohipp, Charmaine; Momoli, Franco; Ritvo, Paul; Spinelli, John; Lacour, Brigitte; Delmas, Dominique; Remen, Thomas; Radon, Katja; Weinmann, Tobias; Klostermann, Swaantje; Heinrich, Sabine; Petridou, Eleni; Bouka, Evdoxia; Panagopoulou, Paraskevi; Dikshit, Rajesh; Nagrani, Rajini; Even-Nir, Hadas; Chetrit, Angela; Maule, Milena; Migliore, Enrica; Filippini, Graziella; Miligi, Lucia; Mattioli, Stefano; Yamaguchi, Naohito; Kojimahara, Noriko; Ha, Mina; Choi, Kyung-Hwa; Mannetje, Andrea ’t; Eng, Amanda; Woodward, Alistair; Carretero, Gema; Alguacil, Juan; Aragones, Nuria; Suare-Varela, Maria Morales; Goedhart, Geertje; Schouten-van Meeteren, A. Antoinette Y. N.; Reedijk, A. Ardine M. J.; Cardis, Elisabeth

2014-01-01

The rapid increase in mobile phone use in young people has generated concern about possible health effects of exposure to radiofrequency (RF) and extremely low frequency (ELF) electromagnetic fields (EMF). MOBI-Kids, a multinational case–control study, investigates the potential effects of childhood and adolescent exposure to EMF from mobile communications technologies on brain tumor risk in 14 countries. The study, which aims to include approximately 1,000 brain tumor cases aged 10–24 years and two individually matched controls for each case, follows a common protocol and builds upon the methodological experience of the INTERPHONE study. The design and conduct of a study on EMF exposure and brain tumor risk in young people in a large number of countries is complex and poses methodological challenges. This manuscript discusses the design of MOBI-Kids and describes the challenges and approaches chosen to address them, including: (1) the choice of controls operated for suspected appendicitis, to reduce potential selection bias related to low response rates among population controls; (2) investigating a young study population spanning a relatively wide age range; (3) conducting a large, multinational epidemiological study, while adhering to increasingly stricter ethics requirements; (4) investigating a rare and potentially fatal disease; and (5) assessing exposure to EMF from communication technologies. Our experience in thus far developing and implementing the study protocol indicates that MOBI-Kids is feasible and will generate results that will contribute to the understanding of potential brain tumor risks associated with use of mobile phones and other wireless communications technologies among young people. PMID:25295243

The MOBI-Kids Study Protocol: Challenges in Assessing Childhood and Adolescent Exposure to Electromagnetic Fields from Wireless Telecommunication Technologies and Possible Association with Brain Tumor Risk.

PubMed

Sadetzki, Siegal; Langer, Chelsea Eastman; Bruchim, Revital; Kundi, Michael; Merletti, Franco; Vermeulen, Roel; Kromhout, Hans; Lee, Ae-Kyoung; Maslanyj, Myron; Sim, Malcolm R; Taki, Masao; Wiart, Joe; Armstrong, Bruce; Milne, Elizabeth; Benke, Geza; Schattner, Rosa; Hutter, Hans-Peter; Woehrer, Adelheid; Krewski, Daniel; Mohipp, Charmaine; Momoli, Franco; Ritvo, Paul; Spinelli, John; Lacour, Brigitte; Delmas, Dominique; Remen, Thomas; Radon, Katja; Weinmann, Tobias; Klostermann, Swaantje; Heinrich, Sabine; Petridou, Eleni; Bouka, Evdoxia; Panagopoulou, Paraskevi; Dikshit, Rajesh; Nagrani, Rajini; Even-Nir, Hadas; Chetrit, Angela; Maule, Milena; Migliore, Enrica; Filippini, Graziella; Miligi, Lucia; Mattioli, Stefano; Yamaguchi, Naohito; Kojimahara, Noriko; Ha, Mina; Choi, Kyung-Hwa; Mannetje, Andrea 't; Eng, Amanda; Woodward, Alistair; Carretero, Gema; Alguacil, Juan; Aragones, Nuria; Suare-Varela, Maria Morales; Goedhart, Geertje; Schouten-van Meeteren, A Antoinette Y N; Reedijk, A Ardine M J; Cardis, Elisabeth

2014-01-01

The rapid increase in mobile phone use in young people has generated concern about possible health effects of exposure to radiofrequency (RF) and extremely low frequency (ELF) electromagnetic fields (EMF). MOBI-Kids, a multinational case-control study, investigates the potential effects of childhood and adolescent exposure to EMF from mobile communications technologies on brain tumor risk in 14 countries. The study, which aims to include approximately 1,000 brain tumor cases aged 10-24 years and two individually matched controls for each case, follows a common protocol and builds upon the methodological experience of the INTERPHONE study. The design and conduct of a study on EMF exposure and brain tumor risk in young people in a large number of countries is complex and poses methodological challenges. This manuscript discusses the design of MOBI-Kids and describes the challenges and approaches chosen to address them, including: (1) the choice of controls operated for suspected appendicitis, to reduce potential selection bias related to low response rates among population controls; (2) investigating a young study population spanning a relatively wide age range; (3) conducting a large, multinational epidemiological study, while adhering to increasingly stricter ethics requirements; (4) investigating a rare and potentially fatal disease; and (5) assessing exposure to EMF from communication technologies. Our experience in thus far developing and implementing the study protocol indicates that MOBI-Kids is feasible and will generate results that will contribute to the understanding of potential brain tumor risks associated with use of mobile phones and other wireless communications technologies among young people.

Asia Pacific Economic Cooperation (APEC) and the 2008 Meetings in Lima, Peru

DTIC Science & Technology

2009-03-31

major retailers and multinational corporations who source products from manufacturers and sourcing companies around the world. In turn, these companies...on orders from U.S., European, or Japanese retailers or brand name distributors to initiate the multinational manufacturing of the consumer products...describes a “patchwork of bilateral hub-and-spoke FTAs in a noodle bowl.” According to some experts, the growth of bilateral trade agreements (BTAs

Multinational Limited Objective Experiment II (MN LOE II)

DTIC Science & Technology

2003-06-01

multinational ONA development to the international players for the first time. Vignette 4 promoted the systems-of-systems approach , the need to...as a result of ongoing famines and economic chaos. The new nation adopted the South Korean form of government and economic system. Concern of a...negative impact on the economy of the south , as they combined with the north, was well founded. Without a Korean “Marshall Plan” instituted by the

A European perspective--the European clinical research infrastructures network.

PubMed

Demotes-Mainard, J; Kubiak, C

2011-11-01

Evaluating research outcomes requires multinational cooperation in clinical research for optimization of treatment strategies and comparative effectiveness research, leading to evidence-based practice and healthcare cost containment. The European Clinical Research Infrastructures Network (ECRIN) is a distributed ESFRI (European Strategy Forum on Research Infrastructures) roadmap pan-European infrastructure designed to support multinational clinical research, making Europe a single area for clinical studies, taking advantage of its population size to access patients, and unlocking latent scientific potential. Servicing multinational trials started during its preparatory phase, and ECRIN will now apply for an ERIC (European Research Infrastructures Consortium) status by 2011. By creating a single area for clinical research in Europe, this achievement will contribute to the implementation of the Europe flagship initiative 2020 'Innovation Union', whose objectives include defragmentation of the research and education capacity, tackling the major societal challenges starting with the area of healthy ageing, and removing barriers to bring ideas to the market.

Lost in Translation? Challenges and Opportunities for Raising Health and Safety Awareness among a Multinational Workforce in the United Arab Emirates

PubMed Central

Cooling, Robert Fletcher; Aw, Tar-Ching

2012-01-01

The United Arab Emirates (UAE) has experienced tremendous economic and industrial growth in the petroleum, airline, maritime and construction sectors, especially since the discovery of oil reserves. Mass recruitment of low skilled or unskilled laborers from less-developed countries has been utilized to satisfy the manpower demands of these fast paced industrial developments. Such workforce recruitment has created an unusual populace demographic, with the total UAE population estimated at 8.3 million, composed of 950,000 Emiratis, with the remainder being multinational expatriate workers, with varying educational qualifications, work experience, religious beliefs, cultural practices, and native languages. These unique characteristics pose a challenge for health and safety professionals tasked with ensuring the UAE workforce adheres to specific occupational health and safety procedures. The paper discusses two case studies that employ a novel multimedia approach to raising health and safety awareness among a multinational workforce. PMID:23251846

Patent foramen ovale closure with GORE HELEX or CARDIOFORM Septal Occluder vs. antiplatelet therapy for reduction of recurrent stroke or new brain infarct in patients with prior cryptogenic stroke: Design of the randomized Gore REDUCE Clinical Study.

PubMed

Kasner, Scott E; Thomassen, Lars; Søndergaard, Lars; Rhodes, John F; Larsen, Coby C; Jacobson, Joth

2017-12-01

Rationale The utility of patent foramen ovale (PFO) closure for secondary prevention in patients with prior cryptogenic stroke is uncertain despite multiple randomized trials completed to date. Aims The Gore REDUCE Clinical Study (REDUCE) aims to establish superiority of patent foramen ovale closure in conjunction with antiplatelet therapy over antiplatelet therapy alone in reducing the risk of recurrent clinical ischemic stroke or new silent brain infarct in patients who have had a cryptogenic stroke. Methods and design This controlled, open-label trial randomized 664 subjects with cryptogenic stroke at 63 multinational sites in a 2:1 ratio to either antiplatelet therapy plus patent foramen ovale closure (with GORE® HELEX® Septal Occluder or GORE® CARDIOFORM Septal Occluder) or antiplatelet therapy alone. Subjects will be prospectively followed for up to five years. Neuroimaging is required for all subjects at baseline and at two years or study exit. Study outcomes The two co-primary endpoints for the study are freedom from recurrent clinical ischemic stroke through at least 24 months post-randomization and incidence of new brain infarct (defined as clinical ischemic stroke or silent brain infarct) through 24 months. The primary analyses are an unadjusted log-rank test and a binomial test of subject-based proportions, respectively, both on the intent-to-treat population, with adjustment for testing multiplicity. Discussion The REDUCE trial aims to target a patient population with truly cryptogenic strokes. Medical therapy is limited to antiplatelet agents in both arms thereby reducing confounding. The trial should determine whether patent foramen ovale closure with the Gore septal occluders is safe and more effective than medical therapy alone for the prevention of recurrent clinical ischemic stroke or new silent brain infarct; the neuroimaging data will provide an opportunity to further support the proof of concept. The main results are anticipated in 2017. Registration Clinical trial registration-URL: http://clinicaltrials.gov/show/NCT00738894.

Specialized stroke rehabilitation services in seven countries: Preliminary results from nine rehabilitation centers.

PubMed

Langhammer, Birgitta; Becker, Frank; Sunnerhagen, Katharina S; Zhang, Tong; Du, Xiaoxia; Bushnik, Tamara; Panchenko, Maria; Keren, Ofer; Banura, Samir; Elessi, Khamis; Luzon, Fuad; Lundgren-Nilsson, Åsa; Li, Xie; Sällström, Susanne; Stanghelle, Johan Kvalvik

2015-12-01

There is a lack of defined levels of rehabilitation, indicating possibly random content and access to specialized services. The aim of the study was to perform a multinational descriptive study of specialized rehabilitation in persons with stroke, to elucidate what the different centers define as prerequisites for specialized rehabilitation, and to analyze whether these descriptions map to currently applied standards or constructs of specialized rehabilitation. A secondary aim was to look for similarities and differences between therapies and services for persons with stroke in the sub-acute stage in the different institutions. Descriptive data of the collaborating centers regarding structure and processes of services were recorded and compared with the British Society of Rehabilitation Medicine and Specialized Services National Definitions sets. Comparisons of the definitions showed that all centers admitted severely disabled persons with stroke, in need of complex rehabilitation, and provided high levels of physical services, with specialized equipment and facilities. However, funding, size, university affiliation, quality accreditation, staffing levels, specialist training, cognitive and vocational services, coordination of the professional teams, admission procedures, time and type of therapies, estimated length of stay, and follow-up procedures differed between the centers. This multinational study of specialized stroke rehabilitation centers shows that a universal definition of specialized rehabilitation is possible, even in quite different countries and settings, in terms of general principles. There were however differences in structures and procedures, which may influence patients' outcomes, indicating a need for refinement of the definitions to be globally applicable. © 2015 World Stroke Organization.

A Medical Student-Delivered Smoking Prevention Program, Education Against Tobacco, for Secondary Schools in Germany: Randomized Controlled Trial.

PubMed

Brinker, Titus Josef; Owczarek, Andreas Dawid; Seeger, Werner; Groneberg, David Alexander; Brieske, Christian Martin; Jansen, Philipp; Klode, Joachim; Stoffels, Ingo; Schadendorf, Dirk; Izar, Benjamin; Fries, Fabian Norbert; Hofmann, Felix Johannes

2017-06-06

More than 8.5 million Germans suffer from chronic diseases attributable to smoking. Education Against Tobacco (EAT) is a multinational network of medical students who volunteer for school-based prevention in the classroom setting, amongst other activities. EAT has been implemented in 28 medical schools in Germany and is present in 13 additional countries around the globe. A recent quasi-experimental study showed significant short-term smoking cessation effects on 11-to-15-year-old adolescents. The aim of this study was to provide the first randomized long-term evaluation of the optimized 2014 EAT curriculum involving a photoaging software for its effectiveness in reducing the smoking prevalence among 11-to-15-year-old pupils in German secondary schools. A randomized controlled trial was undertaken with 1504 adolescents from 9 German secondary schools, aged 11-15 years in grades 6-8, of which 718 (47.74%) were identifiable for the prospective sample at the 12-month follow-up. The experimental study design included measurements at baseline (t1), 6 months (t2), and 12 months postintervention (t3), via questionnaire. The study groups consisted of 40 randomized classes that received the standardized EAT intervention (two medical student-led interactive modules taking 120 minutes total) and 34 control classes within the same schools (no intervention). The primary endpoint was the difference in smoking prevalence from t1 to t3 in the control group versus the difference from t1 to t3 in the intervention group. The differences in smoking behavior (smoking onset, quitting) between the two groups, as well as gender-specific effects, were studied as secondary outcomes. None of the effects were significant due to a high loss-to-follow-up effect (52.26%, 786/1504). From baseline to the two follow-up time points, the prevalence of smoking increased from 3.1% to 5.2% to 7.2% in the control group and from 3.0% to 5.4% to 5.8% in the intervention group (number needed to treat [NNT]=68). Notable differences were observed between the groups for the female gender (4.2% to 9.5% for control vs 4.0% to 5.2% for intervention; NNT=24 for females vs NNT=207 for males), low educational background (7.3% to 12% for control vs 6.1% to 8.7% for intervention; NNT=30), and migrational background (students who claimed that at least one parent was not born in Germany) at the 12-month follow-up. The intervention appears to prevent smoking onset (NNT=63) but does not appear to initiate quitting. The intervention appears to prevent smoking, especially in females and students with a low educational background. ©Titus Josef Brinker, Andreas Dawid Owczarek, Werner Seeger, David Alexander Groneberg, Christian Martin Brieske, Philipp Jansen, Joachim Klode, Ingo Stoffels, Dirk Schadendorf, Benjamin Izar, Fabian Norbert Fries, Felix Johannes Hofmann. Originally published in the Journal of Medical Internet Research (http://www.jmir.org), 06.06.2017.

Pretreatment HIV Drug Resistance and HIV-1 Subtype C Are Independently Associated With Virologic Failure: Results From the Multinational PEARLS (ACTG A5175) Clinical Trial.

PubMed

Kantor, Rami; Smeaton, Laura; Vardhanabhuti, Saran; Hudelson, Sarah E; Wallis, Carol L; Tripathy, Srikanth; Morgado, Mariza G; Saravanan, Shanmugham; Balakrishnan, Pachamuthu; Reitsma, Marissa; Hart, Stephen; Mellors, John W; Halvas, Elias; Grinsztejn, Beatriz; Hosseinipour, Mina C; Kumwenda, Johnstone; La Rosa, Alberto; Lalloo, Umesh G; Lama, Javier R; Rassool, Mohammed; Santos, Breno R; Supparatpinyo, Khuanchai; Hakim, James; Flanigan, Timothy; Kumarasamy, Nagalingeswaran; Campbell, Thomas B; Eshleman, Susan H

2015-05-15

Evaluation of pretreatment HIV genotyping is needed globally to guide treatment programs. We examined the association of pretreatment (baseline) drug resistance and subtype with virologic failure in a multinational, randomized clinical trial that evaluated 3 antiretroviral treatment (ART) regimens and included resource-limited setting sites. Pol genotyping was performed in a nested case-cohort study including 270 randomly sampled participants (subcohort), and 218 additional participants failing ART (case group). Failure was defined as confirmed viral load (VL) >1000 copies/mL. Cox proportional hazards models estimated resistance-failure association. In the representative subcohort (261/270 participants with genotypes; 44% women; median age, 35 years; median CD4 cell count, 151 cells/µL; median VL, 5.0 log10 copies/mL; 58% non-B subtypes), baseline resistance occurred in 4.2%, evenly distributed among treatment arms and subtypes. In the subcohort and case groups combined (466/488 participants with genotypes), used to examine the association between resistance and treatment failure, baseline resistance occurred in 7.1% (9.4% with failure, 4.3% without). Baseline resistance was significantly associated with shorter time to virologic failure (hazard ratio [HR], 2.03; P = .035), and after adjusting for sex, treatment arm, sex-treatment arm interaction, pretreatment CD4 cell count, baseline VL, and subtype, was still independently associated (HR, 2.1; P = .05). Compared with subtype B, subtype C infection was associated with higher failure risk (HR, 1.57; 95% confidence interval [CI], 1.04-2.35), whereas non-B/C subtype infection was associated with longer time to failure (HR, 0.47; 95% CI, .22-.98). In this global clinical trial, pretreatment resistance and HIV-1 subtype were independently associated with virologic failure. Pretreatment genotyping should be considered whenever feasible. NCT00084136. © The Author 2015. Published by Oxford University Press on behalf of the Infectious Diseases Society of America. All rights reserved. For Permissions, please e-mail: journals.permissions@oup.com.

Risk of first cervical HPV infection and pre-cancerous lesions after onset of sexual activity: analysis of women in the control arm of the randomized, controlled PATRICIA trial.

PubMed

Castellsagué, Xavier; Paavonen, Jorma; Jaisamrarn, Unnop; Wheeler, Cosette M; Skinner, S Rachel; Lehtinen, Matti; Naud, Paulo; Chow, Song-Nan; Del Rosario-Raymundo, Maria Rowena; Teixeira, Julio C; Palmroth, Johanna; de Carvalho, Newton S; Germar, Maria Julieta V; Peters, Klaus; Garland, Suzanne M; Szarewski, Anne; Poppe, Willy A J; Romanowski, Barbara; Schwarz, Tino F; Tjalma, Wiebren A A; Bosch, F Xavier; Bozonnat, Marie-Cecile; Struyf, Frank; Dubin, Gary; Rosillon, Dominique; Baril, Laurence

2014-10-30

More information is needed about time between sexual initiation and human papillomavirus (HPV) infection and development of cervical precancer. The objectives were to investigate the time between first sexual activity and detection of first cervical HPV infection or development of first cervical intraepithelial neoplasia (CIN), and associated factors in women from the double-blind, multinational, 4-year PATRICIA trial. PATRICIA enroled women aged 15-25 years with no more than 6 lifetime sexual partners. Women were randomized 1:1 to the HPV-16/18 AS04-adjuvanted vaccine or to control, but only women from the control arm who began sexual intercourse during the study or within 6 months before enrolment, and had no HPV infection detected before the recorded date of their first sexual intercourse, were included in the present analysis. The time between onset of sexual activity and detection of the first cervical HPV infection or development of the first CIN lesion was analyzed using Kaplan-Meier and univariate and multivariable Cox proportional-hazards models. A total of 9337 women were enroled in the control arm of PATRICIA of whom 982 fulfilled the required inclusion criteria for analysis. A cumulative total of 28%, 44%, and 62% of the subjects had HPV infection within 12, 24, and 48 months, respectively. The overall incidence rate was 27.08 per 100 person-years. The most common oncogenic types associated with 6-month persistent infection were HPV-16 (incidence rate: 2.74 per 100 person-years), HPV-51 (2.70), HPV-52 (1.66), HPV-66 (1.14), and HPV-18 (1.09). Increased infection risk was associated with more lifetime sexual partners, being single, Chlamydia trachomatis history, and duration of hormone use. CIN1+ and CIN2+ lesions were most commonly associated with HPV-16, with an overall incidence rate of 1.87 and 1.07 per 100 person-years, respectively. Previous cervical HPV infection was most strongly associated with CIN development. More than 25% of women were infected with HPV within 1 year of beginning sexual activity. Without underestimating the value of vaccination at older ages, our findings emphasize its importance before sexual initiation. clinicaltrials.gov: NCT00122681 .

Efficacy of Lisdexamfetamine in Adults With Moderate to Severe Binge-Eating Disorder: A Randomized Clinical Trial.

PubMed

Hudson, James I; McElroy, Susan L; Ferreira-Cornwell, M Celeste; Radewonuk, Jana; Gasior, Maria

2017-09-01

The ability of pharmacotherapies to prevent relapse and maintain efficacy with long-term treatment in psychiatric conditions is important. To assess lisdexamfetamine dimesylate maintenance of efficacy in adults with moderate to severe binge-eating disorder. A multinational, phase 3, double-blind, placebo-controlled, randomized withdrawal study including 418 participants was conducted at 49 clinical research study sites from January 27, 2014, to April 8, 2015. Eligible adults met DSM-IV-R binge-eating disorder criteria and had moderate to severe binge eating disorder (≥3 binge-eating days per week for 14 days before open-label baseline; Clinical Global Impressions-Severity [CGI-S] scores ≥4 [moderate severity] at screening and open-label baseline). Following a 12-week, open-label phase (dose optimization, 4 weeks [lisdexamfetamine dimesylate, 50 or 70 mg]; dose maintenance, 8 weeks), lisdexamfetamine responders (≤1 binge eating day per week for 4 consecutive weeks and CGI-S scores ≤2 at week 12) were randomized to placebo or continued lisdexamfetamine during a 26-week, double-blind, randomized withdrawal phase. Lisdexamfetamine administration. The primary outcome variable, time to relapse (≥2 binge-eating days per week for 2 consecutive weeks and ≥2-point CGI-S score increases from randomized withdrawal baseline), was analyzed using a log-rank test (primary analysis); the analysis was stratified for dichotomized 4-week cessation status. Safety assessments included treatment-emergent adverse events. Of the 418 participants enrolled in the open-label phase of the study, 411 (358 [87.1%] women; mean [SD] age, 38.3 [10.4] years) were included in the safety analysis set. Of 275 randomized lisdexamfetamine responders (placebo, n = 138; lisdexamfetamine, n = 137), the observed proportions of participants meeting relapse criteria were 3.7% (5 of 136) for lisdexamfetamine and 32.1% (42 of 131) for placebo. Lisdexamfetamine demonstrated superiority over placebo on the log-rank test (χ21, 40.37; P < .001) for time to relapse; the hazard ratio, based on a Cox proportional hazards model for lisdexamfetamine vs placebo, was 0.09 (95% CI, 0.04-0.23). The treatment-emergent adverse events observed were generally consistent with the known profile of lisdexamfetamine. Risk of binge-eating relapse over 6 months was lower in participants continuing lisdexamfetamine than in those randomized to placebo. The hazard for relapse was lower with lisdexamfetamine than placebo. clinicaltrials.gov Identifier: NCT02009163.

New insulin glargine 300 units/mL versus glargine 100 units/mL in people with type 2 diabetes using basal and mealtime insulin: glucose control and hypoglycemia in a 6-month randomized controlled trial (EDITION 1).

PubMed

Riddle, Matthew C; Bolli, Geremia B; Ziemen, Monika; Muehlen-Bartmer, Isabel; Bizet, Florence; Home, Philip D

2014-10-01

To compare the efficacy and safety of new insulin glargine 300 units/mL (Gla-300) with glargine 100 units/mL (Gla-100) in people with type 2 diabetes on basal insulin (≥42 units/day) plus mealtime insulin. EDITION 1 (NCT01499082) was a 6-month, multinational, open-label, parallel-group study. Adults with glycated hemoglobin A1c (HbA1c) 7.0-10.0% (53-86 mmol/mol) were randomized to Gla-300 or Gla-100 once daily with dose titration seeking fasting plasma glucose 4.4-5.6 mmol/L. Primary end point was HbA1c change from baseline; main secondary end point was percentage of participants with one or more confirmed (≤3.9 mmol/L) or severe nocturnal hypoglycemia from week 9 to month 6. Participants (n = 807) had mean age 60 years, diabetes duration 16 years, BMI 36.6 kg/m(2), and HbA1c 8.15% (65.6 mmol/mol). HbA1c reduction was equivalent between regimens; least squares mean difference -0.00% (95% CI -0.11 to 0.11) (-0.00 mmol/mol [-1.2 to 1.2]). Fewer participants reported one or more confirmed (≤3.9 mmol/L) or severe nocturnal hypoglycemic events between week 9 and month 6 with Gla-300 (36 vs. 46% with Gla-100; relative risk 0.79 [95% CI 0.67-0.93]; P < 0.005); nocturnal hypoglycemia incidence and event rates were also lower with Gla-300 in the first 8 weeks of treatment. No between-treatment differences in tolerability or safety were identified. Gla-300 controls HbA1c as well as Gla-100 for people with type 2 diabetes treated with basal and mealtime insulin but with consistently less risk of nocturnal hypoglycemia. © 2014 by the American Diabetes Association. Readers may use this article as long as the work is properly cited, the use is educational and not for profit, and the work is not altered.

Military Review: The Professional Journal of the U.S. Army, August 2008. Special Edition: Counterinsurgency Reader II

DTIC Science & Technology

2008-08-01

method to obtain the information Soldiers need to succeed in counterinsurgency. 133 Paper and COIN: Exploiting the Enemy’s Documents Major Vernie...people (IDPs) Use technicians to make DVDs and web site Extortion: provide “protection” merchant’s vehicles Pass info tea shop grid 17S12345678...merchant who provides printing and materials for paper TCP: Traffic Control Point, SAF: Small Arms Fire, MNF-I: Multi-National Forces-Iraq from local

Acquisition of Armored Vehicles Purchased Through Contract W914NS-05-M-1189

DTIC Science & Technology

2005-10-21

vehicles. Results. The Multi-National Security Transition Command – Iraq (MNSTC-I) purchased seven armored Mercedes - Benz vehicles that did not have...contractor to provide seven armored Mercedes - Benz vehicles. The vehicles were to be used by the Multi-National Security Transition Command (MNSTC-I) to...ability to provide the vehicles immediately. The contract called for the delivery of seven Mercedes - Benz sedans at a price of $135,000 per vehicle that

Distribution Synergy in Multi-National Division-Baghdad during Operation Iraqi Freedom Rotation 07-09

DTIC Science & Technology

2011-06-10

customer wait time (CWT) in Multi-National Division-Baghdad (MND- B ) from October 2007 to January 2008. A secondary objective was to determine what...LIMITATION OF ABSTRACT 18. NUMBER OF PAGES 19a. NAME OF RESPONSIBLE PERSON a. REPORT b . ABSTRACT c. THIS PAGE 19b. PHONE NUMBER (include...Division-Baghdad (MND- B ) from October 2007 to January 2008. A secondary objective was to determine what affect initiatives from operational and

Providing Enterprise Information Services for Multinational Interoperability - The EIM Approach

DTIC Science & Technology

2005-06-01

Federated Search • Document Processing and Archiving • Workflow processing References 1. Perspective on Multinational Information Sharing, Cheryl...layer, with a primary focus on the Application Layers. App Layer Focus Areas Enterprise Content Mgt, Workflow, Business Processes, Federated ... Search Integration Layer – EAI Components Nation 1 Nation 2 Nation 3 … Nation N Silo 1 Silo 2 Silo 3 S ilo N Silo 1 Silo 1 Silo 2 Silo 2 Silo 3 Silo 3 S

Preparing General Purpose Forces in the United States and British Armies for Counterinsurgent Operations

DTIC Science & Technology

2010-12-10

Operations In Iraq: Planning, Combat, And Occupation,” Thomas Ricks’ Fiasco, and reports by Army historian Major Isaiah Wilson, and former CENCTOM J-4...established Multi-National Forces-Iraq, and Lieutenant General Thomas Metz, commander of the Army’s III Corps, assumed the mantle of Multi-National Corps...Donald P. Wright and Colonel Timothy R. Reese or Thomas Ricks’ Fiasco among other books. 18Dr. Carter Malkasian, “Counterinsurgency in Iraq: May 2003

IRS Could Better Protect U.S. Tax Interests in Determining the Income of Multinational Corporations.

DTIC Science & Technology

1981-09-30

together by ties of common ownership and responsive to a common management strat- egy. 2/ Unlike a corporation which conducts business in only one...multinational corporate tax returns. The Assistant Commissi3ner carries out this responsibility through the IRS Examination Divi- sion and Office of...information return would not place an added burden on the corporations be- cause the corporations are currently providing similar data in response to

Institutional arrangements for the reduction of proliferation risks formulation, evaluation, and implementation of institutional concepts. Appendices

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

Not Available

The purpose of this supporting analysis is to provide a foundation for developing a model, an international or multinational institution capable of accomodating the back end of the fuel cycle, while meeting US nonproliferation goals. The analysis is based on a review of selected, defunct and extant institutions which, although not necessarily concerned with nonproliferation, have faced a trade-off between acceptability and effectiveness in meeting their objectives. Discussion of the various institutions is divided into three categories: international organizations, multinational consortia, and cartels or producer associations. Examples of international organizations include the International Seabed Authority, Intelsat, the United Nations andmore » the International Atomic Energy Agency (IAEA). The International Seabed Authority is discussed. Multinational consortia are organizations that have been developed primarily to meet common commercial objectives. Membership includes at least three member nations. Examples include the Scandinavian Airline System (SAS), URENCO, Unilever, Royal Dutch Shell, Eurochemic, Eurodif, Euratom, European Coal and Steel Community, and Serena. Cartels or producer associations are multinational agreements that restrict market forces; viz, production, market share, customers or prices. Examples include the Intergovernmental Council of Copper Exporting Countries (CIPEC), the Organization of Petroleum Exporting Countries (OPEC), and the Fifth International Tin Agreement (ITA), as well as agreements governing diamonds and uranium, bauxite and coffee. OPEC, CIPEC and ITA are discussed.« less

Spirometry quality-control strategies in a multinational study of the prevalence of chronic obstructive pulmonary disease.

PubMed

Pérez-Padilla, Rogelio; Vázquez-García, Juan Carlos; Márquez, María Nelly; Menezes, Ana Maria B

2008-08-01

We report the characteristics of a centralized spirometry quality-control program developed for a population-based survey of the prevalence of chronic obstructive pulmonary disease in 5 cities: São Paulo, Brazil; México City, México; Montevideo, Uruguay; Santiago, Chile; and Caracas, Venezuela (the Latin American Project for the Investigation of Obstructive Lung Diseases [PLATINO]). We developed and used a 3-level quality-control system. Level 1: The spirometer used in the survey (EasyOne), gives quality-control messages to the user/clinician. All the spirometry technicians were trained by the same team, with the aim of meeting what became the 2005 spirometry quality criteria of the American Thoracic Society/European Respiratory Society (ATS/ERS). Level 2: In each of the 5 cities a local supervisor identified poor-quality spirometries that needed to be repeated. Level 3: Once a week during the survey, all spirometry results were sent via e-mail to the study's quality-control center in México City for review and feedback. In the overall totals at the end of the study, 94% of the 5,315 subjects had spirometries that met the 1994 ATS quality criteria, and 89% met the 2005 ATS/ERS criteria. In their overall totals at the end of the study, 90% of the 64 spirometry technicians were successful in getting 86% of their subjects to meet the 1994 ATS criteria, and got 75% of their subjects to meet the 2005 ATS/ERS criteria. In the first 10 subjects they tested, 90% of the 64 spirometry technicians were successful in getting 70% of their subjects to meet the 1994 ATS criteria, and got 60% of their subjects to meet the 2005 ATS/ERS criteria. Standardization of equipment, training, and supervision of spirometry is essential in a multinational spirometry survey. Centralized quality control can be done via e-mail with good reliability and low cost.

Health-related quality of life and functional outcomes from a randomized-withdrawal study of long-term lisdexamfetamine dimesylate treatment in children and adolescents with attention-deficit/hyperactivity disorder.

PubMed

Banaschewski, Tobias; Johnson, Mats; Lecendreux, Michel; Zuddas, Alessandro; Adeyi, Ben; Hodgkins, Paul; Squires, Liza A; Coghill, David R

2014-12-01

The stimulant prodrug lisdexamfetamine dimesylate (LDX) is an effective and generally well tolerated treatment for the symptoms of attention-deficit/hyperactivity disorder (ADHD). Positive impacts of LDX on health-related quality of life and functional impairment have previously been demonstrated in a 7-week, randomized, double-blind, placebo-controlled, phase III study in children and adolescents in Europe. Maintenance of these broad benefits, as well as symptomatic control, is a key goal of long-term management of ADHD. Secondary objectives of this multinational study in children and adolescents with ADHD were to assess the long-term maintenance of effectiveness of LDX in improving health-related quality of life and reducing functional impairment, as gauged using the Child Health and Illness Profile-Child Edition: Parent Report Form (CHIP-CE: PRF) and the Weiss Functional Impairment Rating Scale-Parent Report (WFIRS-P), respectively. Patients aged 6-17 years with diagnosed ADHD and a baseline ADHD Rating Scale IV total score of at least 28 were enrolled from the previous European study and from US sites. Patients who completed an open-label LDX treatment period of at least 26 weeks were randomized (1:1) to continue on their optimized dose of LDX or to switch to placebo for a 6-week, double-blind, withdrawal period. Parents completed CHIP-CE: PRF and WFIRS-P questionnaires at weeks 0, 8 and 26 of the open-label period and at weeks 0 and 6 of the randomized-withdrawal period, or at early termination. The endpoint of each period was defined as the last visit with valid data. Effect sizes were the difference (LDX minus placebo) in least-squares (LS)-mean change from baseline to endpoint divided by root-mean-square error. P values were nominal and not adjusted for multiple comparisons. The open-label and randomized full analysis sets comprised 262 and 153 (LDX n = 76; placebo n = 77) patients, respectively. Mean pretreatment CHIP-CE: PRF T-scores were more than one standard deviation below the normative mean in four of the five domains, and there was significant improvement across all domains from baseline to endpoint of the open-label period. In the randomized-withdrawal period, LS-mean CHIP-CE: PRF T-scores deteriorated in all domains in the placebo group, but not in the LDX group. Compared with placebo, the effect of LDX was significant in the Risk Avoidance (effect size 0.829; p < 0.001), Achievement (0.696; p < 0.001) and Satisfaction (0.636; p < 0.001) domains. Mean pretreatment WFIRS-P scores were lowest in the Family domain and the Learning and School domain. WFIRS-P total score and scores in all domains improved significantly from baseline to endpoint of the open-label period. In the randomized-withdrawal period, LS-mean scores deteriorated in the placebo group but not in the LDX group. Compared with placebo, the effect of LDX was significant in the Family, Learning and School, and Risky Activities domains and in total (effect size 0.908; p < 0.001). Using parent-rated instruments, long-term maintenance of the beneficial effect of LDX in multiple domains of health-related quality of life and functional impairment was demonstrated by comparison of treatment continuation and withdrawal under randomized, double-blind, placebo-controlled conditions.

Ovarian morphology and function during growth hormone therapy of short girls born small for gestational age.

PubMed

Tinggaard, Jeanette; Jensen, Rikke Beck; Sundberg, Karin; Birkebæk, Niels; Christiansen, Peter; Ellermann, Annie; Holm, Kirsten; Jeppesen, Eva Mosfeldt; Kremke, Britta; Marcinski, Pawel; Pedersen, Carsten; Saurbrey, Nina; Thisted, Ebbe; Main, Katharina M; Juul, Anders

2014-12-01

To study the effect of growth hormone (GH) treatment on ovarian and uterine morphology and function in short, prepubertal small-for-gestational-age (SGA) girls. A multinational, randomized controlled trial on safety and efficacy of GH therapy in short, prepubertal children born SGA. Not applicable. A subgroup of 18 Danish girls born SGA included in North European SGA Study (NESGAS). One year of GH treatment (67 μg/kg/day) followed by 2 years of randomized GH treatment (67 μg/kg/day, 35 μg/kg/day, or IGF-I titrated). Data on anthropometrics, reproductive hormones, and ultrasonographic examination of the internal genitalia were collected during 36 months of GH treatment. Uterine and ovarian volume increased significantly during 3 years of treatment (64% and 110%, respectively) but remained low within normal reference ranges. Ovarian follicles became visible in 58% after 1 year compared with 28% before GH therapy. Anti-Müllerian hormone increased significantly during the 3 years of GH therapy but remained within the normal range. Precocious puberty was observed in one girl; another girl developed multicystic ovaries. GH treatment was associated with statistically significant growth of the internal genitalia, but remained within the normal range. As altered pubertal development and ovarian morphology were found in 2 of 18 girls, monitoring of puberty and ovarian function during GH therapy in SGA girls is prudent. Altogether, the findings are reassuring. However, long-term effects of GH treatment on adult reproductive function remain unknown. EudraCT 2005-001507-19. Copyright © 2014 American Society for Reproductive Medicine. Published by Elsevier Inc. All rights reserved.

Linezolid versus Vancomycin in Treatment of Complicated Skin and Soft Tissue Infections

PubMed Central

Weigelt, John; Itani, Kamal; Stevens, Dennis; Lau, William; Dryden, Matthew; Knirsch, Charles

2005-01-01

Skin and soft tissue infections (SSTIs) are a common cause of morbidity in both the community and the hospital. An SSTI is classified as complicated if the infection has spread to the deeper soft tissues, if surgical intervention is necessary, or if the patient has a comorbid condition hindering treatment response (e.g., diabetes mellitus or human immunodeficiency virus). The purpose of this study was to compare linezolid to vancomycin in the treatment of suspected or proven methicillin-resistant gram-positive complicated SSTIs (CSSTIs) requiring hospitalization. This was a randomized, open-label, comparator-controlled, multicenter, multinational study that included patients with suspected or proven methicillin-resistant Staphylococcus aureus (MRSA) infections that involved substantial areas of skin or deeper soft tissues, such as cellulitis, abscesses, infected ulcers, or burns (<10% of total body surface area). Patients were randomized (1:1) to receive linezolid (600 mg) every 12 h either intravenously (i.v.) or orally or vancomycin (1 g) every 12 h i.v. In the intent-to-treat population, 92.2% and 88.5% of patients treated with linezolid and vancomycin, respectively, were clinically cured at the test-of-cure (TOC) visit (P = 0.057). Linezolid outcomes (124/140 patients or 88.6%) were superior to vancomycin outcomes (97/145 patients or 66.9%) at the TOC visit for patients with MRSA infections (P < 0.001). Drug-related adverse events were reported in similar numbers in both the linezolid and the vancomycin arms of the trial. The results of this study demonstrate that linezolid therapy is well tolerated, equivalent to vancomycin in treating CSSTIs, and superior to vancomycin in the treatment of CSSTIs due to MRSA. PMID:15917519

Health impact assessment in multinationals: A case study of the Royal Dutch/Shell Group

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

Birley, Martin

2005-10-15

Health impact assessment is part of the risk management process of multinational corporations/companies. Sexually transmitted infections, including HIV/AIDS, and the 'paradox of plenty' are used as examples of the challenges they face. The 'business case' for impact assessment is explained. The policies, procedures, standards, and activities used by Shell to manage such risks are described. An approach to capacity building and competency development is presented that applies to both company staff and external contractors.

Arctic Collaborative Environment: A New Multi-National Partnership for Arctic Science and Decision Support

NASA Technical Reports Server (NTRS)

Laymon, Charles A,; Kress, Martin P.; McCracken, Jeff E.; Spehn, Stephen L.; Tanner, Steve

2011-01-01

The Arctic Collaborative Environment (ACE) project is a new international partnership for information sharing to meet the challenges of addressing Arctic. The goal of ACE is to create an open source, web-based, multi-national monitoring, analysis, and visualization decision-support system for Arctic environmental assessment, management, and sustainability. This paper will describe the concept, system architecture, and data products that are being developed and disseminated among partners and independent users through remote access.

A multinational Mars mission for the International Space University

NASA Technical Reports Server (NTRS)

Mendell, Wendell W.

1992-01-01

The International Space University's 1991 design project activity has yielded a report on the organization and implementation of a multinational program for manned exploration of Mars; the organization encompasses a political as well as a technical component. This International Manned Mission employs an artificial-gravity spacecraft with nuclear-electric propulsion for interplanetary transfer. An unmanned cargo mission precedes the piloted flights to increase the mass deliverable to Mars, as well as to serve as a testbed for interplanetary vehicle design.

Brands or generics: the dilemma of pharmaceutical marketing in a developing country.

PubMed

Quraeshi, Z A; Luqmani, M; Malhotra, N

1983-01-01

A significant issue in pharmaceutical marketing in many developing countries is whether drugs should be sold by generic or by brand names. In Pakistan, legislation prohibited the sale of brand name drugs in order to increase price competition, and strengthen the market position of indigenous manufacturers to compete against multinationals. However, the government's objectives were not achieved for reasons discussed in the article. The Pakistan case has implications for multinational firms and for other developing countries in similar situations.

Military Airlift: DOD Plans to Participate in Multi-National Program to Exchange Air Services with European Nations

DTIC Science & Technology

2013-10-30

Air Transport, Air-to-Air Refueling and Other Exchange of Services ( ATARES ) program.1 ATARES is a European program through which member nations use a... ATARES is managed by the Movement Coordination Centre Europe (MCCE), a multi-national organization established in July 2007 to coordinate and optimize...of ATARES but is seeking to join the program. DOD is a member of MCCE and pays a fee for this membership; there is no additional fee to become a

A phase 2, open-label, multicenter study of the long-term safety of siltuximab (an anti-interleukin-6 monoclonal antibody) in patients with multicentric Castleman disease.

PubMed

van Rhee, Frits; Casper, Corey; Voorhees, Peter M; Fayad, Luis E; van de Velde, Helgi; Vermeulen, Jessica; Qin, Xiang; Qi, Ming; Tromp, Brenda; Kurzrock, Razelle

2015-10-06

Multicentric Castleman disease (MCD) is a rare, systemic lymphoproliferative disorder driven by interleukin (IL)-6 overproduction. Siltuximab, an anti-IL-6 monoclonal antibody, has demonstrated durable tumor and symptomatic responses in a multinational, randomized, placebo-controlled study of MCD. This preplanned safety analysis was conducted to evaluate the long-term safety of siltuximab treatment among 19 patients with MCD who had stable disease or better and were enrolled in a phase-1 study and subsequent ongoing, open-label, phase-2 extension study. Dosing was 11 mg/kg administered intravenously every 3 weeks, per protocol, or every 6 weeks at the investigator's discretion. Safety monitoring focused on potential risks associated with the anti-IL-6 mechanism of action. Investigator-assessed disease control status was also documented. Median treatment duration for the 19 patients was 5.1 (range 3.4, 7.2) years, with 14 (74%) patients treated for >4 years. Grade-≥ 3 adverse events (AEs) reported in >1 patient included hypertension (n = 3) and nausea, cellulitis, and fatigue (n = 2 each). Grade-≥ 3 AEs at least possibly attributed to siltuximab were leukopenia, lymphopenia, and a serious AE of polycythemia (n = 1 each). Hypertriglyceridemia and hypercholesterolemia (total cholesterol) were reported in 8 and 9 patients, respectively. No disease relapses were observed, and 8 of 19 patients were able to switch to an every-6-week dosing schedule. All MCD patients in this extension study have received siltuximab for a prolonged duration (up to 7 years) without evidence of cumulative toxicity or treatment discontinuations and with few serious infections. All patients are alive, demonstrate sustained disease control, and continue to receive siltuximab.

The Mediating Effect of Self-Control on Parenting and Delinquency: A Gendered Approach With a Multinational Sample.

PubMed

Muftić, Lisa R; Updegrove, Alexander H

2017-08-01

This study aims to clarify the relationships between parenting techniques, low self-control, and juvenile delinquency in Gottfredson and Hirschi's general theory of crime while controlling for alternative explanations of delinquency. We relied on a sample of 35,511 adolescent students from 31 countries from the International Self-Report Delinquency 2 Study. Results indicate that parenting exhibits a direct effect on adolescents' violence perpetration and property offending, and that while self-control weakens the strength of this relationship, it fails to fully mediate it. Males reported lower levels of self-control, exposure to poorer parenting techniques, and higher rates of violence perpetration and property offending. The relationship between parenting, self-control, and juvenile delinquency was similar for females and males. These results provide evidence that parenting has important implications for adolescents' involvement in delinquency above and beyond its influence on their level of self-control.

[Lean production and psychosocial risks: the case of a multinational merger in a metallurgical company in Brazil].

PubMed

Stenger, Eunice; Monteiro, Maria Inês; Sabino, Marcos Oliveira; Miquilin, Isabella de Oliveira Campos; Corrêa Filho, Heleno Rodrigues

2014-08-01

This study focused on the method known as "lean production" as a work-related psychosocial risk factor in a Brazilian multinational auto parts company after its merger with other multinational companies. The authors conducted a qualitative analysis of two time points: the first using on-site observation and key interviews with managers and workers during implementation of lean production in 1996; the second, 16 years later, comparing data from a document search in labor inspection records from the Ministry of Labor and Employment and legal proceedings initiated by the Office of the Public Prosecutor for Labor Affairs. The merger led to layoffs, replacements, and an increase in the workday. A class action suit was filed on grounds of aggravated working conditions. The new production model led to psychosocial risks that increased the need for workers' health precautions when changes in the production process introduced new and increased risks of physical and mental illnesses.

A mission design for International Manned Mars Mission - From the 1991 International Space University (ISU) Design Project

NASA Technical Reports Server (NTRS)

Mendell, Wendell W.

1991-01-01

The International Space University (ISU) conducted a study of an international program to support human exploration of Mars as its annual Design Project activity during its 1991 summer session in Toulouse, France. Although an ISU Design Project strives to produce an in-depth analysis during the intense 10-week summer session, the International Mars Mission (IMM) project was conducted in a manner designed to provide a learning experience for young professionals working in an unusual multidisciplinary and multinational environment. The breadth of the IMM study exceeds that of most Mars mission studies of the past, encompassing political organization for long-term commitment, multinational management structure, cost analysis, mission architecture, vehicle configuration, crew health, life support, Mars surface infrastructure, mission operations, technology evaluation, risk assessment, scientific planning, exploration, communication networks, and Martian resource utilization. The IMM Final Report has particular value for those seeking insight into the choices made by a multinational group working in an apolitical environment on the problems of international cooperation in space.

Family, Community, and Health System Considerations for Reducing the Burden of Pediatric Sickle Cell Disease in Uganda Through Newborn Screening

PubMed Central

Green, Nancy S.; Mathur, Sanyukta; Kiguli, Sarah; Makani, Julie; Fashakin, Victoria; LaRussa, Philip; Lyimo, Magdalena; Abrams, Elaine J.; Mulumba, Lukia; Mupere, Ezekiel

2016-01-01

Sickle cell disease (SCD) is associated with high mortality for children under 5 years of age in sub-Saharan Africa. Newborn sickle screening program and enhanced capacity for SCD treatment are under development to reduce disease burden in Uganda and elsewhere in the region. Based on an international stakeholder meeting and a family-directed conference on SCD in Kampala in 2015, and interviews with parents, multinational experts, and other key informants, we describe health care, community, and family perspectives in support of these initiatives. Key stakeholder meetings, discussions, and interviews were held to understand perspectives of public health and multinational leadership, patients and families, as well as national progress, resource needs, medical and social barriers to program success, and resources leveraged from HIV/AIDS. Partnering with program leadership, professionals, patients and families, multinational stakeholders, and leveraging resources from existing programs are needed for building successful programs in Uganda and elsewhere in sub-Saharan Africa. PMID:27336011

Double standards: the multinational asbestos industry and asbestos-related disease in South Africa.

PubMed

McCulloch, Jock; Tweedale, Geoffrey

2004-01-01

This study documents and contrasts the development of knowledge about asbestos-related disease (ARD) in South Africa and the United Kingdom. It also contributes to the globalization debate by exploring corporate decision-making in a multinational industry. Between the 1930s and 1960s, the leading U.K. asbestos companies developed a sophisticated knowledge of ARD, though in South Africa, where the leading companies such as Turner & Newall and Cape Asbestos owned mines, there was little attempt to apply this knowledge. Asbestos mines (and their environments) in South Africa were uniquely dusty and ARD was rife. Social and political factors in South Africa, especially apartheid, allowed these companies to apply double standards, even after 1960 when the much more serious hazard of mesothelioma was identified. This shows the need for greater regulation of multinationals. Because of the lack of such regulation in the early 1960s, an opportunity was lost to prevent the current high morbidity and mortality of ARD both in South Africa and worldwide.

Methodology for clinical trials involving patients with cancer who have febrile neutropenia: updated guidelines of the Immunocompromised Host Society/Multinational Association for Supportive Care in Cancer, with emphasis on outpatient studies.

PubMed

Feld, Ronald; Paesmans, Marianne; Freifeld, Alison G; Klastersky, Jean; Pizzo, Philip A; Rolston, Kenneth V I; Rubenstein, Edward; Talcott, James A; Walsh, Thomas J

2002-12-15

Two multinational organizations, the Immunocompromised Host Society and the Multinational Association for Supportive Care in Cancer, have produced for investigators and regulatory bodies a set of guidelines on methodology for clinical trials involving patients with febrile neutropenia. The guidelines suggest that response (i.e., success of initial empirical antibiotic therapy without any modification) be determined at 72 h and again on day 5, and the reasons for modification should be stated. Blinding and stratification are to be encouraged, as should statistical consideration of trials specifically designed for showing equivalence. Patients enrolled in outpatient studies should be selected by use of a validated risk model, and patients should be carefully monitored after discharge from the hospital. Response and safety parameters should be recorded along with readmission rates. If studies use these guidelines, comparisons between studies will be simpler and will lead to further improvements in patient therapy.

Opportunities and Challenges of Multinational Pharmaceutical Enterprises in Transforming Pharmaceutical Market in China.

PubMed

Hu, Linfeng; Yu, Zhong; Yuan, Qingwen; Hu, Yuanjia; Ung, Carolina Oi Lam

2018-01-01

The surging costs of health care in China is highly related to the high expenses in pharmaceutical costs. Since the Government of China launched the health care reform in 2009, the issue of growing pharmaceutical expenditure continues to grasp policy makers' attention. Since 2015, an ongoing series of drug-related policies have been revised or developed, resulting in profound impact on the overall pharmaceutical market in China, and the dynamic is still evolving. As China has become the second largest pharmaceutical market in the world, any volatility in the Chinese pharmaceutical market may have great implications to multinational pharmaceutical markets that have had their products launched in China or plan to extend their business to the Chinese market. Based on a comprehensive analysis of the most recent health care reform policies in China, the objectives of this study were to identify the major opportunities appealed to and the challenges confronted by multinational pharmaceutical enterprises in the current Chinese pharmaceutical market.

[Why multi-national clinical trials now?--Industry perspective].

PubMed

Miki, Satoshi

2007-02-01

Clinical trial environment in Japan has issues such as high clinical development cost, resource-intensive and time-consuming preparation for clinical trial conduct in each clinical site, long "White Space" and slow speed in pt.recruitment. As a result of the Guideline revision in Nov., 2005, overseas' Phase III data is now usable as pivotal data for NDA submissions. Therefore, acceleration of "hollowing out of clinical trails for registration in Japan has been the significant concern. Under such circumstances, the possible solution would be to participate in the Multi-National Clinical Trials." While other Asian countries, EU and the US have rich precedents and experiences in conducting Multi-National Clinical Trials, Japan was left alone and other Asian countries do not need any collaboration with Japan. It is proposed that Japan take initiative to set up the network such as "Asian Clinical Trial Group" and collaborate with other Asian countries from the beginning of early stage development. Eventually, Asia should become the third region to create clinical evidence, same as to EU and the US.

Evidence-Based Guideline: Treatment of Convulsive Status Epilepticus in Children and Adults: Report of the Guideline Committee of the American Epilepsy Society

PubMed Central

Shinnar, Shlomo; Gloss, David; Alldredge, Brian; Arya, Ravindra; Bainbridge, Jacquelyn; Bare, Mary; Bleck, Thomas; Dodson, W. Edwin; Garrity, Lisa; Jagoda, Andy; Lowenstein, Daniel; Pellock, John; Riviello, James; Sloan, Edward; Treiman, David M.

2016-01-01

CONTEXT: The optimal pharmacologic treatment for early convulsive status epilepticus is unclear. OBJECTIVE: To analyze efficacy, tolerability and safety data for anticonvulsant treatment of children and adults with convulsive status epilepticus and use this analysis to develop an evidence-based treatment algorithm. DATA SOURCES: Structured literature review using MEDLINE, Embase, Current Contents, and Cochrane library supplemented with article reference lists. STUDY SELECTION: Randomized controlled trials of anticonvulsant treatment for seizures lasting longer than 5 minutes. DATA EXTRACTION: Individual studies were rated using predefined criteria and these results were used to form recommendations, conclusions, and an evidence-based treatment algorithm. RESULTS: A total of 38 randomized controlled trials were identified, rated and contributed to the assessment. Only four trials were considered to have class I evidence of efficacy. Two studies were rated as class II and the remaining 32 were judged to have class III evidence. In adults with convulsive status epilepticus, intramuscular midazolam, intravenous lorazepam, intravenous diazepam and intravenous phenobarbital are established as efficacious as initial therapy (Level A). Intramuscular midazolam has superior effectiveness compared to intravenous lorazepam in adults with convulsive status epilepticus without established intravenous access (Level A). In children, intravenous lorazepam and intravenous diazepam are established as efficacious at stopping seizures lasting at least 5 minutes (Level A) while rectal diazepam, intramuscular midazolam, intranasal midazolam, and buccal midazolam are probably effective (Level B). No significant difference in effectiveness has been demonstrated between intravenous lorazepam and intravenous diazepam in adults or children with convulsive status epilepticus (Level A). Respiratory and cardiac symptoms are the most commonly encountered treatment-emergent adverse events associated with intravenous anticonvulsant drug administration in adults with convulsive status epilepticus (Level A). The rate of respiratory depression in patients with convulsive status epilepticus treated with benzodiazepines is lower than in patients with convulsive status epilepticus treated with placebo indicating that respiratory problems are an important consequence of untreated convulsive status epilepticus (Level A). When both are available, fosphenytoin is preferred over phenytoin based on tolerability but phenytoin is an acceptable alternative (Level A). In adults, compared to the first therapy, the second therapy is less effective while the third therapy is substantially less effective (Level A). In children, the second therapy appears less effective and there are no data about third therapy efficacy (Level C). The evidence was synthesized into a treatment algorithm. CONCLUSIONS: Despite the paucity of well-designed randomized controlled trials, practical conclusions and an integrated treatment algorithm for the treatment of convulsive status epilepticus across the age spectrum (infants through adults) can be constructed. Multicenter, multinational efforts are needed to design, conduct and analyze additional randomized controlled trials that can answer the many outstanding clinically relevant questions identified in this guideline. PMID:26900382

Seven rules of international distribution.

PubMed

Arnold, D

2000-01-01

A multinational entering a new market in a developing country knows that on its own, it cannot master local business practices, meet regulatory requirements, hire and manage local personnel, and gain access to potential customers. So it partners with a local distributor. At first, sales take off, revenues grow, and the entry seems like a smart move. But when sales plateau, the corporation begins blaming the distributor for not investing sufficiently in business growth or expanding markets, and the distributor claims that it hasn't received enough support and that the corporation's expectations are too high. The key to solving such problems lies in recognizing that the phases are predictable and can be planned for. As a new business grows in an emerging market, its marketing strategy needs to evolve, and each sequential phase requires different skills, financial investments, and management resources. The author offers seven strategies to manage the multinational-distributor partnership. He discusses what to consider when choosing a distributor, how to structure the relationship between the two partners, what resources the multinational should commit, and what can be expected in return. He states that a successful distributor must risk investing in training, information services, and advertising and promotion in order to implement the company's marketing strategy and grow the business. Paying attention at the start of a partnership can result in a better working relationship between a multinational and a distributor, along with more consistent sales and growth for the corporation.

Auto-titrating continuous positive airway pressure treatment for obstructive sleep apnoea after acute quadriplegia (COSAQ): study protocol for a randomized controlled trial

PubMed Central

2013-01-01

Background Quadriplegia is a severe, catastrophic injury that predominantly affects people early in life, resulting in lifelong physical disability. Obstructive sleep apnoea is a direct consequence of quadriplegia and is associated with neurocognitive deficits, sleepiness and reduced quality of life. The usual treatment for sleep apnoea is nasal continuous positive airway pressure (CPAP); however, this is poorly tolerated in quadriplegia. To encourage patients to use this therapy, we have to demonstrate that the benefits outweigh the inconvenience. We therefore propose a prospective, multinational randomized controlled trial of three months of CPAP for obstructive sleep apnoea after acute quadriplegia. Methods/design Specialist spinal cord injury centres across Australia, New Zealand, the UK and Canada will recruit medically stable individuals who have sustained a (new) traumatic quadriplegia (complete or incomplete second cervical to first thoracic level lesions). Participants will be screened for obstructive sleep apnoea using full, portable sleep studies. Those with an apnoea hypopnoea index greater than 10 per hour will proceed to an initial three-night trial of CPAP. Those who can tolerate CPAP for at least 4 hours on at least one night of the initial trial will be randomized to either usual care or a 3-month period of auto-titrating CPAP. The primary hypothesis is that nocturnal CPAP will improve neuropsychological functioning more than usual care alone. The secondary hypothesis is that the magnitude of improvement of neuropsychological function will be predicted by the severity of baseline sleepiness measures, sleep fragmentation and sleep apnoea. Neuropsychological tests and full polysomnography will be performed at baseline and 3 months with interim measures of sleepiness and symptoms of autonomic dysfunction measured weekly. Spirometry will be performed monthly. Neuropsychological tests will be administered by blinded assessors. Recruitment commenced in July 2009. Discussion The results of this trial will demonstrate the effect of nocturnal CPAP treatment of obstructive sleep apnoea in acute quadriplegia. If CPAP can improve neurocognitive function after injury, it is likely that rehabilitation and subsequent community participation will be substantially improved for this group of predominantly young and severely physically disabled people. Trial registration Australian New Zealand Clinical Trial Registry ACTRN12605000799651 PMID:23777510

Efficacy of Lisdexamfetamine in Adults With Moderate to Severe Binge-Eating Disorder

PubMed Central

McElroy, Susan L.; Ferreira-Cornwell, M. Celeste; Radewonuk, Jana; Gasior, Maria

2017-01-01

Importance The ability of pharmacotherapies to prevent relapse and maintain efficacy with long-term treatment in psychiatric conditions is important. Objective To assess lisdexamfetamine dimesylate maintenance of efficacy in adults with moderate to severe binge-eating disorder. Design, Setting, and Participants A multinational, phase 3, double-blind, placebo-controlled, randomized withdrawal study including 418 participants was conducted at 49 clinical research study sites from January 27, 2014, to April 8, 2015. Eligible adults met DSM-IV-R binge-eating disorder criteria and had moderate to severe binge eating disorder (≥3 binge-eating days per week for 14 days before open-label baseline; Clinical Global Impressions−Severity [CGI-S] scores ≥4 [moderate severity] at screening and open-label baseline). Following a 12-week, open-label phase (dose optimization, 4 weeks [lisdexamfetamine dimesylate, 50 or 70 mg]; dose maintenance, 8 weeks), lisdexamfetamine responders (≤1 binge eating day per week for 4 consecutive weeks and CGI-S scores ≤2 at week 12) were randomized to placebo or continued lisdexamfetamine during a 26-week, double-blind, randomized withdrawal phase. Interventions Lisdexamfetamine administration. Main Outcomes and Measures The primary outcome variable, time to relapse (≥2 binge-eating days per week for 2 consecutive weeks and ≥2-point CGI-S score increases from randomized withdrawal baseline), was analyzed using a log-rank test (primary analysis); the analysis was stratified for dichotomized 4-week cessation status. Safety assessments included treatment-emergent adverse events. Results Of the 418 participants enrolled in the open-label phase of the study, 411 (358 [87.1%] women; mean [SD] age, 38.3 [10.4] years) were included in the safety analysis set. Of 275 randomized lisdexamfetamine responders (placebo, n = 138; lisdexamfetamine, n = 137), the observed proportions of participants meeting relapse criteria were 3.7% (5 of 136) for lisdexamfetamine and 32.1% (42 of 131) for placebo. Lisdexamfetamine demonstrated superiority over placebo on the log-rank test (χ21, 40.37; P < .001) for time to relapse; the hazard ratio, based on a Cox proportional hazards model for lisdexamfetamine vs placebo, was 0.09 (95% CI, 0.04-0.23). The treatment-emergent adverse events observed were generally consistent with the known profile of lisdexamfetamine. Conclusions and Relevance Risk of binge-eating relapse over 6 months was lower in participants continuing lisdexamfetamine than in those randomized to placebo. The hazard for relapse was lower with lisdexamfetamine than placebo. Trial Registration clinicaltrials.gov Identifier: NCT02009163 PMID:28700805

Comparisons of hypertension-related costs from multinational clinical studies.

PubMed

Mullins, C Daniel; Sikirica, Mirko; Seneviratne, Viran; Ahn, Jeonghoon; Akhras, Kasem S

2004-01-01

This study identifies and compares the individual cost components of hospital and ambulatory services that manage the care of hypertensive patients in eight countries: the US, the UK, France, Spain, Germany, Italy, Canada and Australia. Hypertension-related costs are classified according to four major cardiovascular events: (i) acute myocardial infarction; (ii) congestive heart failure; (iii) stroke; and (iv) renal failure, which was subdivided into renal failure treated by dialysis and renal failure treated by kidney transplantation. To make cross-country costs comparisons, we used the DRG codes used in the US and DRG-like codes from each country. US cost information was obtained from hypertension data available from the literature and health economics researchers. For costs in other countries, we consulted with national health economics experts in each country, used analyses by the Research Triangle Institute, and performed Medline and international literature searches. When available, we obtained information from the countries' public and private nationally representative data sources. For cross-country currency adjustments, all currencies were converted using the Purchasing Power Parities from the Organisation for Economic Cooperation and Development, and then converted into inflation-adjusted year 2000 US dollars. There exists considerable variation in hypertension-related costs from multinational clinical studies. This study documents that costs are generally higher in the US than in other countries; however, this is not always true. In particular, costs of treating heart failure in France and the costs of renal failure without transplantation in Germany and the UK are relatively high. While analysing multinational hypertensive cost data, this study also addresses the impact of cross-country cost variations on cost analyses. During the last decade, drug-development researchers have drawn extensively upon multinational trials to resolve enrollment problems and drug-registration issues. At the same time, formulary decision-makers are increasingly demanding multinational cost-effectiveness analyses of the clinical differences found between drug-treatment regimens. Since these data are typically not captured by randomised clinical trials, standard cost estimates must be applied to the clinical trials' resource data, although such standardised calculations do not necessarily account for clinical and cost variations between countries. This paper serves as an instrument for identifying which national and event cost data are comparable for analysis as well as highlighting specific problem areas for cost data integration. Although the study focuses on hypertension-related costs, its results may provide insight for multinational cost comparisons of other diseases where similar hospitalisation costs may be analysed.

Association Between Environmental Tobacco Smoke Exposure and the Occurrence of EGFR Mutations and ALK Rearrangements in Never-smokers With Non-Small-cell Lung Cancer: Analyses From a Prospective Multinational ETS Registry.

PubMed

Soo, Ross A; Kubo, Akihito; Ando, Masahiko; Kawaguchi, Tomoya; Ahn, Myung-Ju; Ou, Sai-Hong Ignatius

2017-09-01

Molecular studies have demonstrated actionable driver oncogene alterations are more frequent in never-smokers with non-small-cell lung cancer (NSCLC). The etiology of these driver oncogenes in patients with NSCLC remains unknown, and environmental tobacco smoke (ETS) is a potential cause in these cases. We assembled clinical and genetic information for never-smoker patients with NSCLC accrued in Japan, Korea, Singapore, and the United States. To determine an association between cumulative ETS and activating EGFR mutations or ALK rearrangements, the Mantel extension test was used. Multivariate analysis on activating EGFR and ALK gene rearrangements was performed using the generalized linear mixed model with nations as a random effect. From July 2007 to December 2012, 498 never-smokers with pathologically proven NSCLC were registered and tested for the association between ETS and EGFR and ALK status. EGFR mutations were more frequent in the ever-ETS cohort (58.4%) compared with the never-ETS cohort (39.6%), and the incidence of EGFR mutations was significantly associated with the increment of cumulative ETS (cETS) in female never-smokers (P = .033), whereas the incidence of ALK rearrangements was not significantly different between the ever-ETS and never-ETS cohorts. Odds ratio for EGFR mutations for each 10-year increment in cETS was 1.091 and 0.89 for female and male never-smokers (P = .031 and P = .263, respectively). Increased ETS exposure was closely associated with EGFR mutations in female never-smokers with NSCLC in the expanded multinational cohort. However, the association of ETS and ALK rearrangements in never-smokers with NSCLC was not significant. Copyright © 2017 Elsevier Inc. All rights reserved.

CYP2D6 genotype in relation to hot flashes as tamoxifen side effect in a Dutch cohort of the tamoxifen exemestane adjuvant multinational (TEAM) trial.

PubMed

Dezentjé, Vincent O; Gelderblom, Hans; Van Schaik, Ron H N; Vletter-Bogaartz, Judith M; Van der Straaten, Tahar; Wessels, Judith A M; Kranenbarg, Elma Meershoek-Klein; Berns, Els M; Seynaeve, Caroline; Putter, Hein; Van de Velde, Cornelis J H; Nortier, Johan W R; Guchelaar, Henk-Jan

2014-01-01

In tamoxifen-treated breast cancer patients the occurrence of hot flashes may be associated with effective estrogen receptor antagonism dependent on genetic variations of metabolic enzymes and the estrogen receptor. Early breast cancer patients who were randomized to receive tamoxifen, followed by exemestane within the tamoxifen exemestane adjuvant multinational trial were genotyped for five CYP2D6 alleles. CYP2D6 genotypes and phenotypes were related to the occurrence of hot flashes as adverse event during the first year of tamoxifen use (primary aim) and the time to the occurrence of hot flashes as AE during the complete time on tamoxifen (secondary aim). In addition, exploratory analyses on 22 genetic variants of other metabolic enzymes and two common polymorphisms in the estrogen receptor-1 were performed. No association was found between the CYP2D6 genotype/phenotype or any other genetic variant and hot flashes during the first year. Only higher age was related to a lower incidence of hot flashes in the first year (adjusted odds ratio 0.94, 95 % CI 0.92-0.96; p < 0.001). The ESR1 PvuII XbaI CG haplotype was associated with the time to the occurrence of hot flashes during the complete time on tamoxifen (CG/CG vs. CG/other + other/other: adjusted hazard ratio 0.49, 95 % CI 0.25-0.97; p = 0.04). In conclusion, the CYP2D6 genotypes and phenotypes were not associated with the occurrence of hot flashes. Common polymorphisms in the estrogen receptor-1 might predict hot flashes as common tamoxifen side effect, although this finding needs replication.

Telemedicine deployments within NATO military forces: a data analysis of current and projected capabilities.

PubMed

Lam, David M; Poropatich, Ronald K

2008-11-01

Since the creation of the NATO Telemedicine Expert Panel (now renamed the TMED Expert Team) in 2000, when few nations had deployed telemedicine systems to support military field operations, this group has been encouraging the nations to deploy telemedicine (TMED) in support of their forces, and to write the use of TMED into NATO doctrine. This has been a relatively successful effort, and TMED is increasingly being used within the military medical structures of some NATO and Partnership for Peace nations to provide medical care to deployed military personnel. We report the results of a multinational survey of current and projected availability of various telemedicine modalities within the NATO medical services that are participating in the work of the TMED expert team (ET). Though only a "snapshot in time," and not representing all NATO nations, this is the first attempt to identify both current and planned TMED utilization within the multinational military medical community. Participating nations report that communication systems now in place at the lowest levels of medical support increasingly enable the routine use of Web-based teleconsultation modalities. Teleradiology is now being seen as the de facto standard for imaging support. While a number of nations report they have deployed capabilities for obtaining clinical consultations at a distance, most responding nations do not have a formal organizational structure to control and manage remote consultation and rely on informal clinical relationships (e.g., requesting consults from the deployed clinician's home hospital or from friends). Military electronic health records are in use by only a minority of nations and fewer still are capable of civilian interface. Less common TMED capabilities (e.g., tele-microbiology, tele-pathology, tele-medical maintenance) are being increasingly used, but are still rarely deployed. As a result of the findings of this survey, specific recommendations for expanding the use of TMED in the NATO multinational medical setting have been made to appropriate NATO bodies.

Lessons from tobacco control for advocates of healthy transport.

PubMed

Mindell, J

2001-06-01

Many parallels can be drawn between cigarettes and motor vehicles, smoking and car driving, and the tobacco and the auto/oil industries. Those promoting healthy and sustainable transport policies can learn lessons from tobacco control activities over the past 50 years. Evidence-based legislation is more effective than negotiated voluntary agreements between industry and government. Media advocacy is crucial to reframe the issues to allow changes in national policies that facilitate healthier choices. Worthwhile public health policies seen as a threat by multinational companies will be opposed by them but active national and international networks of healthcare professionals, voluntary organizations, charities and their supporters can match the political power of these industries.

Rebuilding Iraq: DoD and State Department Have Improved Oversight and Coordination of Private Security Contractors in Iraq, but Further Actions are Needed to Sustain Improvements

DTIC Science & Technology

2008-07-01

MNC-I Multi-National Corps-Iraq MNF-I Multi-National Force-Iraq PSC private security contractor RSO Regional Security Office TOC tactical...maritime and territorial jurisdiction’ to include a housing complex leased by the U.S. military on a military base in Germany where a sexual assault...and monitored by RSO personnel in the RSO TOC . Motorcade vehicles are equipped with video cameras that record and document motorcade movements and

Technology, the evolution of the transnational corporation, and the nation-state: A speculative essay

NASA Technical Reports Server (NTRS)

Miller, A. S.

1972-01-01

This study deals with two exceedingly complex matters; first, the causal connection between technology and the rise of giant transnational or multinational corporations, and second, the impact that development is having on the political order called the nation-state. It is concluded that the multinational enterprise and the nation-state are the major participants in the planetary order; that the enterprise has a political role and the state has an economic role; and that they are conjoined ever increasingly into a system of global corporativism.

Attempts to undermine tobacco control: tobacco industry "youth smoking prevention" programs to undermine meaningful tobacco control in Latin America.

PubMed

Sebrié, Ernesto M; Glantz, Stanton A

2007-08-01

We sought to understand how the tobacco industry uses "youth smoking prevention" programs in Latin America. We analyzed tobacco industry documents, so-called "social reports," media reports, and material provided by Latin American public health advocates. Since the early 1990s, multinational tobacco companies have promoted "youth smoking prevention" programs as part of their "Corporate Social Responsibility" campaigns. The companies also partnered with third-party allies in Latin America, most notably nonprofit educational organizations and education and health ministries. Even though there is no evidence that these programs reduce smoking among youths, they have met the industry's goal of portraying the companies as concerned corporate citizens and undermining effective tobacco control interventions that are required by the World Health Organization Framework Convention on Tobacco Control.

Rationale and trial design of Bardoxolone Methyl Evaluation in Patients with Chronic Kidney Disease and Type 2 Diabetes: the Occurrence of Renal Events (BEACON).

PubMed

de Zeeuw, Dick; Akizawa, Tadao; Agarwal, Rajiv; Audhya, Paul; Bakris, George L; Chin, Melanie; Krauth, Melissa; Lambers Heerspink, Hiddo J; Meyer, Colin J; McMurray, John J; Parving, Hans-Henrik; Pergola, Pablo E; Remuzzi, Giuseppe; Toto, Robert D; Vaziri, Nosratola D; Wanner, Christoph; Warnock, David G; Wittes, Janet; Chertow, Glenn M

2013-01-01

Chronic kidney disease (CKD) associated with type 2 diabetes mellitus constitutes a global epidemic complicated by considerable renal and cardiovascular morbidity and mortality, despite the provision of inhibitors of the renin-angiotensin-aldosterone system (RAAS). Bardoxolone methyl, a synthetic triterpenoid that reduces oxidative stress and inflammation through Nrf2 activation and inhibition of NF-κB was previously shown to increase estimated glomerular filtration rate (eGFR) in patients with CKD associated with type 2 diabetes mellitus. To date, no antioxidant or anti-inflammatory therapy has proved successful at slowing the progression of CKD. Herein, we describe the design of Bardoxolone Methyl Evaluation in Patients with Chronic Kidney Disease and Type 2 Diabetes: the Occurrence of Renal Events (BEACON) trial, a multinational, multicenter, double-blind, randomized, placebo-controlled Phase 3 trial designed to determine whether long-term administration of bardoxolone methyl (on a background of standard therapy, including RAAS inhibitors) safely reduces renal and cardiac morbidity and mortality. The primary composite endpoint is time-to-first occurrence of either end-stage renal disease or cardiovascular death. Secondary endpoints include the change in eGFR and time to occurrence of cardiovascular events. BEACON will be the first event-driven trial to evaluate the effect of an oral antioxidant and anti-inflammatory drug in advanced CKD. Copyright © 2013 S. Karger AG, Basel.

Testing two methods to create comparable scale scores between the Job Content Questionnaire (JCQ) and JCQ-like questionnaires in the European JACE Study.

PubMed

Karasek, Robert; Choi, BongKyoo; Ostergren, Per-Olof; Ferrario, Marco; De Smet, Patrick

2007-01-01

Scale comparative properties of "JCQ-like" questionnaires with respect to the JCQ have been little known. Assessing validity and reliability of two methods for generating comparable scale scores between the Job Content Questionnaire (JCQ) and JCQ-like questionnaires in sub-populations of the large Job Stress, Absenteeism and Coronary Heart Disease European Cooperative (JACE) study: the Swedish version of Demand-Control Questionnaire (DCQ) and a transformed Multinational Monitoring of Trends and Determinants in Cardiovascular Disease Project (MONICA) questionnaire. A random population sample of all Malmo males and females aged 52-58 (n = 682) years was given a new test questionnaire with both instruments (the JCQ and the DCQ). Comparability-facilitating algorithms were created (Method I). For the transformed Milan MONICA questionnaire, a simple weighting system was used (Method II). The converted scale scores from the JCQ-like questionnaires were found to be reliable and highly correlated to those of the original JCQ. However, agreements for the high job strain group between the JCQ and the DCQ, and between the JCQ and the DCQ (Method I applied) were only moderate (Kappa). Use of a multiple level job strain scale generated higher levels of job strain agreement, as did a new job strain definition that excludes the intermediate levels of the job strain distribution. The two methods were valid and generally reliable.

Salt Use Behaviours of Ghanaians and South Africans: A Comparative Study of Knowledge, Attitudes and Practices

PubMed Central

Menyanu, Elias; Russell, Joanna; Biritwum, Richard; Kowal, Paul

2017-01-01

Salt consumption is high in Africa and the continent also shares the greatest burden of hypertension. This study examines salt-related knowledge, attitude and self-reported behaviours (KAB) amongst adults from two African countries—Ghana and South Africa—which have distributed different public health messages related to salt. KAB was assessed in the multinational longitudinal World Health Organisation (WHO) study on global AGEing and adult health (WHO-SAGE) Wave 2 (2014–2015). Respondents were randomly selected across both countries—Ghana (n = 6746; mean age 58 years old; SD 17; 41% men; 31% hypertensive) and South Africa (n = 3776, mean age 54 years old; SD 17; 32% men; 45% hypertensive). South Africans were more likely than Ghanaians to add salt to food at the table (OR 4.80, CI 4.071–5.611, p < 0.001) but less likely to add salt to food during cooking (OR 0.16, CI 0.130–0.197, p < 0.001). South Africans were also less likely to take action to control their salt intake (OR 0.436, CI 0.379–0.488, p < 0.001). Considering the various salt reduction initiatives of South Africa that have been largely absent in Ghana, this study supports additional efforts to raise consumer awareness on discretionary salt use and behaviour change in both countries. PMID:28846641

Implementation fidelity of Multidimensional Family Therapy in an international trial.

PubMed

Rowe, Cynthia; Rigter, Henk; Henderson, Craig; Gantner, Andreas; Mos, Kees; Nielsen, Philip; Phan, Olivier

2013-04-01

Implementation fidelity, a critical aspect of clinical trials research that establishes adequate delivery of the treatment as prescribed in treatment manuals and protocols, is also essential to the successful implementation of effective programs into new practice settings. Although infrequently studied in the drug abuse field, stronger implementation fidelity has been linked to better outcomes in practice but appears to be more difficult to achieve with greater distance from model developers. In the INternational CAnnabis Need for Treatment (INCANT) multi-national randomized clinical trial, investigators tested the effectiveness of Multidimensional Family Therapy (MDFT) in comparison to individual psychotherapy (IP) in Brussels, Berlin, Paris, The Hague, and Geneva with 450 adolescents with a cannabis use disorder and their parents. This study reports on the implementation fidelity of MDFT across these five Western European sites in terms of treatment adherence, dose and program differentiation, and discusses possible implications for international implementation efforts. Copyright © 2013 Elsevier Inc. All rights reserved.

Attempts to Undermine Tobacco Control

PubMed Central

Sebrié, Ernesto M.; Glantz, Stanton A.

2007-01-01

We sought to understand how the tobacco industry uses “youth smoking prevention” programs in Latin America. We analyzed tobacco industry documents, so-called “social reports,” media reports, and material provided by Latin American public health advocates. Since the early 1990s, multinational tobacco companies have promoted “youth smoking prevention” programs as part of their “Corporate Social Responsibility” campaigns. The companies also partnered with third-party allies in Latin America, most notably nonprofit educational organizations and education and health ministries. Even though there is no evidence that these programs reduce smoking among youths, they have met the industry’s goal of portraying the companies as concerned corporate citizens and undermining effective tobacco control interventions that are required by the World Health Organization Framework Convention on Tobacco Control. PMID:17600260

[ECRIN (European clinical research infrastructures network), a pan-European infrastructure for clinical research].

PubMed

Demotes-Mainard, Jacques

2010-12-01

Clinical research plays a key role both in the development of innovative health products and in the optimisation of medical strategies, leading to evidence-based practice and healthcare cost containment. ECRIN is a distributed ESFRI-roadmap pan-European infrastructure designed to support multinational clinical research, making Europe a single area for clinical studies, taking advantage of its population size to access patients, and unlocking latent scientific providing services to multinational. Servicing of multinational trials started during the preparatory phase, and ECRIN has applied for ERIC status in 2011. In parallel, ECRIN has also proposed an FP7 integrating activity project to further develop, upgrade and expand the ECRIN infrastructure built up during the past FP6 and FP7 projects, facilitating an efficient organization of clinical research in Europe, with ECRIN developing generic tools and providing generic services for multinational studies, and supporting the construction of pan-European disease-oriented networks that will in turn act as ECRIN users. This organization will improve Europe's attractiveness for industry trials, boost its scientific competitiveness, and result in better healthcare for European citizens. The three medical areas supported in this project (rare diseases, medical devices, and nutrition) will serve as pilots for other biomedical research fields. By creating a single area for clinical research in Europe, this structure will contribute to the implementation of the Europe flagship initiative 2020 'Innovation Union', whose objectives include defragmentation of research and educational capacities, tackling the major societal challenges (starting with healthy aging), and removing barriers to bringing ideas to the market.

A Multinational Survey on Actual Diagnostics and Treatment of Subacute Sclerosing Panencephalitis.

PubMed

Häusler, Martin; Aksoy, Ayse; Alber, Michael; Altunbasak, Sakir; Angay, Aydan; Arsene, Oana Tarta; Craiu, Dana; Hartmann, Hans; Hiz-Kurul, Semra; Ichiyama, Takashi; Iliescu, Catrinel; Jocic-Jakubi, Bosanka; Korinthenberg, Rudolf; Köse, Gülsen; Lukban, Marissa B; Ozkan, Mehpare; Patcheva, Iliyana; Teichler, Jens; Vintan, Mihaela; Yaramis, Ahmet; Yarar, Coskun; Yis, Uluc; Yuksel, Deniz; Anlar, Banu

2015-12-01

Subacute sclerosing panencephalitis (SSPE) is a chronic infection of the central nervous system caused by the measles virus (MV). Its prevalence remains high in resource poor countries and is likely to increase in the Northern Europe as vaccination rates decrease. Clinical knowledge of this devastating condition, however, is limited. We therefore conducted this multinational survey summarizing experience obtained from more than 500 patients treated by 24 physicians in seven countries. SSPE should be considered in all patients presenting with otherwise unexplained acquired neurological symptoms. In most patients, the diagnosis will be established by the combination of typical clinical symptoms (characteristic repetitive myoclonic jerks), a strong intrathecal synthesis of antibodies to MV and typical electroencephalogram findings (Radermecker complexes). Whereas the therapeutic use of different antiviral (amantadine, ribavirin) and immunomodulatory drugs (isoprinosine, interferons) and of immunoglobulins has been reported repeatedly, optimum application regimen of these drugs has not been established. This is partly due to the absence of common diagnostic and clinical standards focusing on neurological and psychosocial aspects. Carbamazepine, levetiracetam, and clobazam are the drugs most frequently used to control myoclonic jerks. We have established a consensus on essential laboratory and clinical parameters that should facilitate collaborative studies. Those are urgently needed to improve outcome. Georg Thieme Verlag KG Stuttgart · New York.

A historical and socioeconomic analysis of occupational safety and health in India.

PubMed

Vilanilam, J V

1980-01-01

Workers in poor countries of the so-called Third World are more likely to be affected by the dangers of high technology than their counterparts in wealthier countries. Owing to their lack of education, most workers in the "developing" world are unaware of the hazards of their occupations. Moreover, their general backwardness in sanitation and nutrition and climatic proneness of their geographic region to epidemics cause diseases contracted from the work environment to be aggravated. occupational diseases are often misconstrued as diseases resulting from the general environment. Since unemployment in underdeveloped countries is of a very high order, workers are prepared to accept any job, irrespective of the dangers involved. Labor is cheap and easily replaceable, so employers see no need for improving occupational safety and health. Labor unions are mostly controlled by full-time politicians who consider health a political issue, especially when their party controls the country's government. The seriousness of all these factors is heightened by the existing socioeconomic order in poor countries, in which national medievalism and multinational modernism play a crucial role. In order to understand the prevailing socioeconomic order, one has to analyze the social structures of poor countries in the context of today's world economic structure. India is taken as an example of a "developing" country where all the above-mentioned factors and many others are in operation: backwardness of the worker; poor nutrition; lack of concern for public health; proneness to epidemics; and indifference on the part of employers, politicians, and unions toward occupational health; high unemployment, control of the local economy by multinational corporations; and control of the mass media by feudalistic vested interests. This article attempts to analyze the occupational health and safety issue in India from a historical perspective, and stresses the vital need of structural changes in various fields so that workers can have a safe and healthy working environment.

Safety and efficacy of BAY 94-9027, a prolonged-half-life factor VIII.

PubMed

Reding, M T; Ng, H J; Poulsen, L H; Eyster, M E; Pabinger, I; Shin, H-J; Walsch, R; Lederman, M; Wang, M; Hardtke, M; Michaels, L A

2017-03-01

Essentials Recombinant factor VIII BAY 94-9027 conjugates in a site-specific manner with polyethylene glycol. BAY 94-9027 was given to patients with severe hemophilia A as prophylaxis and to treat bleeds. BAY 94-9027 prevented bleeds at dose intervals up to every 7 days and effectively treated bleeds. BAY 94-9027 treatment was mainly well tolerated and no patient developed factor VIII inhibitors. Click to hear Dr Tiede's perspective on half-life extended factor VIII for the treatment of hemophilia A SUMMARY: Background BAY 94-9027 is a B-domain-deleted prolonged-half-life recombinant factor VIII (FVIII) that conjugates in a site-specific manner with polyethylene glycol. Objective Assess efficacy and safety of BAY 94-9027 for prophylaxis and treatment of bleeds in patients with severe hemophilia A. Patients/methods In this multinational, phase 2/3, partially randomized, open-label trial, men aged 12-65 years with FVIII < 1% and ≥ 150 exposure days to FVIII received BAY 94-9027 for 36 weeks on demand or prophylactically at intervals determined following a 10-week run-in period on 25 IU kg -1 body weight two times per week. Patients with > 1 bleed during the run-in subsequently received 30-40 IU kg -1 two times per week; patients with ≤ 1 bleed were eligible for randomization to every-5-days (45-60 IU kg -1 ) or every-7-days (60 IU kg -1 ) prophylaxis (1 : 1) for 26 additional weeks until randomization arms were filled. Patients who were eligible but not randomized continued twice-weekly prophylaxis. The primary efficacy outcome was annualized bleeding rate (ABR). Results The intent-to-treat population included 132 patients (prophylaxis, n = 112; on demand, n = 20). Median ABR (quartile [Q1; Q3]) for patients treated two times per week who were not eligible for randomization (n = 13) improved after dose increase (17.4 [14.3; 26.0] to 4.1 [2.0; 10.6]). Median ABR for patients randomized to every-5-days treatment (n = 43) was 1.9 (0; 4.2), similar to patients eligible for randomization but who continued treatment two times per week (n = 11). Median ABR for 32/43 patients (74%) who continued every-7-days prophylaxis until study end was 0.96 (0.0; 4.3). Six hundred and thirty-six of 702 bleeds (90.6%) were controlled with ≤ 2 infusions. No patient developed a FVIII inhibitor. Conclusions BAY 94-9027 prevented bleeding across three individually tailored dose regimens and was effective for treatment of bleeds. © 2016 The Authors. Journal of Thrombosis and Haemostasis published by Wiley Periodicals, Inc. on behalf of International Society on Thrombosis and Haemostasis.

Clinical Research: A Globalized Network

PubMed Central

Richter, Trevor A.

2014-01-01

Clinical research has become increasingly globalized, but the extent of globalization has not been assessed. To describe the globalization of clinical research, we used all (n = 13,208) multinational trials registered at ClinicalTrials.gov to analyzed geographic connections among individual countries. Our findings indicate that 95% (n = 185) of all countries worldwide have participated in multinational clinical research. Growth in the globalization of clinical research peaked in 2009, suggesting that the global infrastructure that supports clinical research might have reached its maximum capacity. Growth in the globalization of clinical research is attributable to increased involvement of non-traditional markets, particularly in South America and Asia. Nevertheless, Europe is the most highly interconnected geographic region (60.64% of global connections), and collectively, Europe, North America, and Asia comprise more than 85% of all global connections. Therefore, while the expansion of clinical trials into non-traditional markets has increased over the last 20 years and connects countries across the globe, traditional markets still dominate multinational clinical research, which appears to have reached a maximum global capacity. PMID:25517976

An integrated and pragmatic approach: Global plant safety management

NASA Astrophysics Data System (ADS)

McNutt, Jack; Gross, Andrew

1989-05-01

The Bhopal disaster in India in 1984 has compelled manufacturing companies to review their operations in order to minimize their risk exposure. Much study has been done on the subject of risk assessment and in refining safety reviews of plant operations. However, little work has been done to address the broader needs of decision makers in the multinational environment. The corporate headquarters of multinational organizations are concerned with identifying vulnerable areas to assure that appropriate risk-minimization measures are in force or will be taken. But the task of screening global business units for safety prowess is complicated and time consuming. This article takes a step towards simplifying this process by presenting the decisional model developed by the authors. Beginning with an overview of key issues affecting global safety management, the focus shifts to the multinational vulnerability model developed by the authors, which reflects an integration of approaches. The article concludes with a discussion of areas for further research. While the global chemical industry and major incidents therein are used for illustration, the procedures and solutions suggested here are applicable to all manufacturing operations.

Examining cross-cultural differences in autism spectrum disorder: A multinational comparison from Greece, Italy, Japan, Poland, and the United States.

PubMed

Matson, J L; Matheis, M; Burns, C O; Esposito, G; Venuti, P; Pisula, E; Misiak, A; Kalyva, E; Tsakiris, V; Kamio, Y; Ishitobi, M; Goldin, R L

2017-05-01

Autism spectrum disorder (ASD) is characterized by social and communication impairments as well as restricted, repetitive behavior patterns. Despite the fact that ASD is reported worldwide, very little research exists examining ASD characteristics on a multinational scale. Cross-cultural comparisons are especially important for ASD, since cultural differences may impact the perception of symptoms. Identifying behaviors that are similarly reported as problematic across cultures as well as identifying behaviors in which there is cultural variation could aid in the development and refinement of more universally effective measures. The present study sought to examine similarities and differences in caregiver endorsement of symptom severity through scores on the Baby Infant Screen for Children with aUtIsm Traits (BISCUIT). The BISCUIT was utilized to examine ASD core symptomology in 250 toddlers diagnosed with ASD from Greece, Italy, Japan, Poland, and the United States. Significant differences in overall ASD symptom severity and endorsement were found between multinational groups. Implications of the results are discussed. Copyright © 2016 Elsevier Masson SAS. All rights reserved.

European COMPARative Effectiveness research on blended Depression treatment versus treatment-as-usual (E-COMPARED): study protocol for a randomized controlled, non-inferiority trial in eight European countries.

PubMed

Kleiboer, Annet; Smit, Jan; Bosmans, Judith; Ruwaard, Jeroen; Andersson, Gerhard; Topooco, Naira; Berger, Thomas; Krieger, Tobias; Botella, Cristina; Baños, Rosa; Chevreul, Karine; Araya, Ricardo; Cerga-Pashoja, Arlinda; Cieślak, Roman; Rogala, Anna; Vis, Christiaan; Draisma, Stasja; van Schaik, Anneke; Kemmeren, Lise; Ebert, David; Berking, Matthias; Funk, Burkhardt; Cuijpers, Pim; Riper, Heleen

2016-08-03

Effective, accessible, and affordable depression treatment is of high importance considering the large personal and economic burden of depression. Internet-based treatment is considered a promising clinical and cost-effective alternative to current routine depression treatment strategies such as face-to-face psychotherapy. However, it is not clear whether research findings translate to routine clinical practice such as primary or specialized mental health care. The E-COMPARED project aims to gain knowledge on the clinical and cost-effectiveness of blended depression treatment compared to treatment-as-usual in routine care. E-COMPARED will employ a pragmatic, multinational, randomized controlled, non-inferiority trial in eight European countries. Adults diagnosed with major depressive disorder (MDD) will be recruited in primary care (Germany, Poland, Spain, Sweden, and the United Kingdom) or specialized mental health care (France, The Netherlands, and Switzerland). Regular care for depression is compared to "blended" service delivery combining mobile and Internet technologies with face-to-face treatment in one treatment protocol. Participants will be followed up at 3, 6, and 12 months after baseline to determine clinical improvements in symptoms of depression (primary outcome: Patient Health Questionnaire-9), remission of depression, and cost-effectiveness. Main analyses will be conducted on the pooled data from the eight countries (n = 1200 in total, 150 participants in each country). The E-COMPARED project will provide mental health care stakeholders with evidence-based information and recommendations on the clinical and cost-effectiveness of blended depression treatment. France: ClinicalTrials.gov NCT02542891 . Registered on 4 September 2015; Germany: German Clinical Trials Register DRKS00006866 . Registered on 2 December 2014; The Netherlands: Netherlands Trials Register NTR4962 . Registered on 5 January 2015; Poland: ClinicalTrials.Gov NCT02389660 . Registered on 18 February 2015; Spain: ClinicalTrials.gov NCT02361684 . Registered on 8 January 2015; Sweden: ClinicalTrials.gov NCT02449447 . Registered on 30 March 2015; Switzerland: ClinicalTrials.gov NCT02410616 . Registered on 2 April 2015; United Kingdom: ISRCTN registry, ISRCTN12388725 . Registered on 20 March 2015.

Sandia SCADA Program -- High Surety SCADA LDRD Final Report

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

CARLSON, ROLF E.

2002-04-01

Supervisory Control and Data Acquisition (SCADA) systems are a part of the nation's critical infrastructure that is especially vulnerable to attack or disruption. Sandia National Laboratories is developing a high-security SCADA specification to increase the national security posture of the U.S. Because SCADA security is an international problem and is shaped by foreign and multinational interests, Sandia is working to develop a standards-based solution through committees such as the IEC TC 57 WG 15, the IEEE Substation Committee, and the IEEE P1547-related activity on communications and controls. The accepted standards are anticipated to take the form of a Common Criteriamore » Protection Profile. This report provides the status of work completed and discusses several challenges ahead.« less

CREATION OF A MODEL TO PREDICT SURVIVAL IN PATIENTS WITH REFRACTORY COELIAC DISEASE USING A MULTINATIONAL REGISTRY

PubMed Central

Rubio-Tapia, Alberto; Malamut, Georgia; Verbeek, Wieke H.M.; van Wanrooij, Roy L.J.; Leffler, Daniel A.; Niveloni, Sonia I.; Arguelles-Grande, Carolina; Lahr, Brian D.; Zinsmeister, Alan R.; Murray, Joseph A.; Kelly, Ciaran P.; Bai, Julio C.; Green, Peter H.; Daum, Severin; Mulder, Chris J.J.; Cellier, Christophe

2016-01-01

Background Refractory coeliac disease is a severe complication of coeliac disease with heterogeneous outcome. Aim To create a prognostic model to estimate survival of patients with refractory coeliac disease. Methods We evaluated predictors of 5-year mortality using Cox proportional hazards regression on subjects from a multinational registry. Bootstrap re-sampling was used to internally validate the individual factors and overall model performance. The mean of the estimated regression coefficients from 400 bootstrap models was used to derive a risk score for 5-year mortality. Results The multinational cohort was composed of 232 patients diagnosed with refractory coeliac disease across 7 centers (range of 11–63 cases per center). The median age was 53 years and 150 (64%) were women. A total of 51 subjects died during 5-year follow-up (cumulative 5-year all-cause mortality = 30%). From a multiple variable Cox proportional hazards model, the following variables were significantly associated with 5-year mortality: age at refractory coeliac disease diagnosis (per 20 year increase, hazard ratio = 2.21; 95% confidence interval: 1.38, 3.55), abnormal intraepithelial lymphocytes (hazard ratio = 2.85; 95% confidence interval: 1.22, 6.62), and albumin (per 0.5 unit increase, hazard ratio = 0.72; 95% confidence interval: 0.61, 0.85). A simple weighted 3-factor risk score was created to estimate 5-year survival. Conclusions Using data from a multinational registry and previously-reported risk factors, we create a prognostic model to predict 5-year mortality among patients with refractory coeliac disease. This new model may help clinicians to guide treatment and follow-up. PMID:27485029

Mind the Gap! A Multilevel Analysis of Factors Related to Variation in Published Cost-Effectiveness Estimates within and between Countries.

PubMed

Boehler, Christian E H; Lord, Joanne

2016-01-01

Published cost-effectiveness estimates can vary considerably, both within and between countries. Despite extensive discussion, little is known empirically about factors relating to these variations. To use multilevel statistical modeling to integrate cost-effectiveness estimates from published economic evaluations to investigate potential causes of variation. Cost-effectiveness studies of statins for cardiovascular disease prevention were identified by systematic review. Estimates of incremental costs and effects were extracted from reported base case, sensitivity, and subgroup analyses, with estimates grouped in studies and in countries. Three bivariate models were developed: a cross-classified model to accommodate data from multinational studies, a hierarchical model with multinational data allocated to a single category at country level, and a hierarchical model excluding multinational data. Covariates at different levels were drawn from a long list of factors suggested in the literature. We found 67 studies reporting 2094 cost-effectiveness estimates relating to 23 countries (6 studies reporting for more than 1 country). Data and study-level covariates included patient characteristics, intervention and comparator cost, and some study methods (e.g., discount rates and time horizon). After adjusting for these factors, the proportion of variation attributable to countries was negligible in the cross-classified model but moderate in the hierarchical models (14%-19% of total variance). Country-level variables that improved the fit of the hierarchical models included measures of income and health care finance, health care resources, and population risks. Our analysis suggested that variability in published cost-effectiveness estimates is related more to differences in study methods than to differences in national context. Multinational studies were associated with much lower country-level variation than single-country studies. These findings are for a single clinical question and may be atypical. © The Author(s) 2015.

Unleash innovation in foreign subsidiaries.

PubMed

Birkinshaw, J; Hood, N

2001-03-01

In multinational corporations, growth-triggering innovation often emerges in foreign subsidiaries from employees closest to customers and least attached to the procedures and politeness of the home office. But too often, heavy-handed responses from headquarters squelch local enthusiasm and drive out good ideas--and good people. The authors' research into more than 50 multinationals suggests that encouraging innovation in foreign subsidiaries requires a change in attitude. Companies should start to think of foreign subsidiaries as peninsulas rather than as islands--as extensions of the company's strategic domain rather than as isolated outposts. If they do, innovative ideas will flow more freely from the periphery to the corporate center. Basing their arguments on a rich array of examples, the authors say that encouraging such "innovation at the edges" also requires a new set of practices, with two aims: to improve the formal and informal channels of communication between headquarters and subsidiaries and to give foreign subsidiaries more authority to see their ideas through. The challenge for executives of multinationals is to find ways to liberalize, not tighten, internal systems and to delegate more authority to local subsidiaries. It isn't enough to ask subsidiary managers to be innovative; corporate managers need to give them incentives and support systems to facilitate their efforts. The authors suggest four approaches: give seed money to subsidiaries; use formal requests for proposals as a way of increasing the demand for seed money; encourage subsidiaries to be incubators for fledgling businesses; and build international networks. As part of the last approach, multinationals also need to create roles for idea brokers who can link entrepreneurs in foreign subsidiaries with other parts of the company.

Contemporary management of acute coronary syndromes: does the practice match the evidence? The global registry of acute coronary events (GRACE).

PubMed

Carruthers, K F; Dabbous, O H; Flather, M D; Starkey, I; Jacob, A; Macleod, D; Fox, K A A

2005-03-01

To determine to what extent evidence based guidelines are followed in the management of acute coronary syndromes (ACS) in the UK, elsewhere in Europe, and multinationally, and what the outcomes are. Multinational, prospective, observational registry (GRACE, global registry of acute coronary events) with six months' follow up. Patients presenting to a cluster of hospitals. The study was designed to collect data representative of the full spectrum of ACS in specific geographic populations. Patients admitted with a working diagnosis of unstable angina or suspected myocardial infarction (MI). Death during hospitalisation and at six months' follow up (adjusted for baseline risks). In ST elevation MI, reperfusion was applied more often in the UK (71%) than in Europe (65%) and multinationally (59%) (p < 0.01). However, this was almost entirely by lytic treatment, in contrast with elsewhere (primary percutaneous coronary intervention 1%, 29%, 16%, respectively). Statins were applied more frequently in the UK for all classes of patients with ACS (p < 0.0001). In contrast there was lower use of revascularisation procedures in non-ST MI (20% v 37% v 28%, respectively) and glycoprotein IIb/IIIa antagonists (6% v 25% v 26%, respectively). In-hospital death rates, adjusted for baseline risk, were not significantly different but six month death rates were higher in the UK for ST elevation MI (7.2% UK, 4.3% Europe, 5.3% multinationally; p < 0.0001) and non-ST elevation MI (7.5%, 6.2%, and 6.7%, respectively; p = 0.012, UK v Europe). Current management of ACS in the UK more closely follows the recommendations of the National Service Framework than British or European guidelines. Differences in practice may account for the observed higher event rates in the UK after hospital discharge.

Creation of a model to predict survival in patients with refractory coeliac disease using a multinational registry.

PubMed

Rubio-Tapia, A; Malamut, G; Verbeek, W H M; van Wanrooij, R L J; Leffler, D A; Niveloni, S I; Arguelles-Grande, C; Lahr, B D; Zinsmeister, A R; Murray, J A; Kelly, C P; Bai, J C; Green, P H; Daum, S; Mulder, C J J; Cellier, C

2016-10-01

Refractory coeliac disease is a severe complication of coeliac disease with heterogeneous outcome. To create a prognostic model to estimate survival of patients with refractory coeliac disease. We evaluated predictors of 5-year mortality using Cox proportional hazards regression on subjects from a multinational registry. Bootstrap resampling was used to internally validate the individual factors and overall model performance. The mean of the estimated regression coefficients from 400 bootstrap models was used to derive a risk score for 5-year mortality. The multinational cohort was composed of 232 patients diagnosed with refractory coeliac disease across seven centres (range of 11-63 cases per centre). The median age was 53 years and 150 (64%) were women. A total of 51 subjects died during a 5-year follow-up (cumulative 5-year all-cause mortality = 30%). From a multiple variable Cox proportional hazards model, the following variables were significantly associated with 5-year mortality: age at refractory coeliac disease diagnosis (per 20 year increase, hazard ratio = 2.21; 95% confidence interval, CI: 1.38-3.55), abnormal intraepithelial lymphocytes (hazard ratio = 2.85; 95% CI: 1.22-6.62), and albumin (per 0.5 unit increase, hazard ratio = 0.72; 95% CI: 0.61-0.85). A simple weighted three-factor risk score was created to estimate 5-year survival. Using data from a multinational registry and previously reported risk factors, we create a prognostic model to predict 5-year mortality among patients with refractory coeliac disease. This new model may help clinicians to guide treatment and follow-up. © 2016 John Wiley & Sons Ltd.

A four-country comparison of healthcare systems, implementation of diagnostic criteria, and treatment availability for functional gastrointestinal disorders: a report of the Rome Foundation Working Team on cross-cultural, multinational research.

PubMed

Schmulson, M; Corazziari, E; Ghoshal, U C; Myung, S-J; Gerson, C D; Quigley, E M M; Gwee, K-A; Sperber, A D

2014-10-01

Variations in healthcare provision around the world may impact how patients with functional gastrointestinal disorder (FGIDs) are investigated, diagnosed, and treated. However, these differences have not been reviewed. The Multinational Working Team of the Rome Foundation, established to make recommendations on the conduct of multinational, cross-cultural research in FGIDs, identified seven key issues that are analyzed herein: (i) coverage afforded by different healthcare systems/providers; (ii) level of the healthcare system where patients with FGIDs are treated; (iii) extent/types of diagnostic procedures typically undertaken to diagnose FGIDs; (iv) physicians' familiarity with and implementation of the Rome diagnostic criteria in clinical practice; (v) range of medications approved for FGIDs and approval process for new agents; (vi) costs involved in treating FGIDs; and (vii) prevalence and role of complementary/alternative medicine (CAM) for FGIDs. Because it was not feasible to survey all countries around the world, we compared a selected number of countries based on their geographical and ethno-cultural diversity. Thus, we included Italy and South Korea as representative of nations with broad-based coverage of healthcare in the population and India and Mexico as newly industrialized countries where there may be limited provision of healthcare for substantial segments of the population. In light of the paucity of formal publications on these issues, we included additional sources from the medical literature as well as perspectives provided by local experts and the media. Finally, we provide future directions on healthcare issues that should be taken into account and implemented when conducting cross-cultural and multinational research in FGIDs. © 2014 John Wiley & Sons Ltd.

From public health to international law: possible protocols for inclusion in the Framework Convention on Tobacco Control.

PubMed Central

Joossens, L.

2000-01-01

Faced with a difficult business environment in the United States and the falling demand for cigarettes in industrialized countries, multinational tobacco companies have been competing fiercely to expand their sales in developing countries. Because of the worldwide threat posed by smoking to health and the emphasis being placed by international tobacco companies on marketing in developing countries, an international regulatory strategy, such as the WHO proposed Framework Convention on Tobacco Control, is needed. This review describes from a public health perspective the possible scope and key considerations of protocols that should be included in the convention. The key international areas that should be considered in tobacco control are: prices, smuggling; tax-free tobacco products; advertising and sponsorship; the Internet; testing methods; package design and labelling; agriculture; and information sharing. PMID:10994267

A Canadian Critical Care Trials Group project in collaboration with the international forum for acute care trialists - Collaborative H1N1 Adjuvant Treatment pilot trial (CHAT): study protocol and design of a randomized controlled trial

PubMed Central

2011-01-01

Background Swine origin influenza A/H1N1 infection (H1N1) emerged in early 2009 and rapidly spread to humans. For most infected individuals, symptoms were mild and self-limited; however, a small number developed a more severe clinical syndrome characterized by profound respiratory failure with hospital mortality ranging from 10 to 30%. While supportive care and neuraminidase inhibitors are the main treatment for influenza, data from observational and interventional studies suggest that the course of influenza can be favorably influenced by agents not classically considered as influenza treatments. Multiple observational studies have suggested that HMGCoA reductase inhibitors (statins) can exert a class effect in attenuating inflammation. The Collaborative H1N1 Adjuvant Treatment (CHAT) Pilot Trial sought to investigate the feasibility of conducting a trial during a global pandemic in critically ill patients with H1N1 with the goal of informing the design of a larger trial powered to determine impact of statins on important outcomes. Methods/Design A multi-national, pilot randomized controlled trial (RCT) of once daily enteral rosuvastatin versus matched placebo administered for 14 days for the treatment of critically ill patients with suspected, probable or confirmed H1N1 infection. We propose to randomize 80 critically ill adults with a moderate to high index of suspicion for H1N1 infection who require mechanical ventilation and have received antiviral therapy for ≤ 72 hours. Site investigators, research coordinators and clinical pharmacists will be blinded to treatment assignment. Only research pharmacy staff will be aware of treatment assignment. We propose several approaches to informed consent including a priori consent from the substitute decision maker (SDM), waived and deferred consent. The primary outcome of the CHAT trial is the proportion of eligible patients enrolled in the study. Secondary outcomes will evaluate adherence to medication administration regimens, the proportion of primary and secondary endpoints collected, the number of patients receiving open-label statins, consent withdrawals and the effect of approved consent models on recruitment rates. Discussion Several aspects of study design including the need to include central randomization, preserve allocation concealment, ensure study blinding compare to a matched placebo and the use novel consent models pose challenges to investigators conducting pandemic research. Moreover, study implementation requires that trial design be pragmatic and initiated in a short time period amidst uncertainty regarding the scope and duration of the pandemic. Trial Registration Number ISRCTN45190901 PMID:21388549

GH treatment to final height produces similar height gains in patients with SHOX deficiency and Turner syndrome: results of a multicenter trial.

PubMed

Blum, Werner F; Ross, Judith L; Zimmermann, Alan G; Quigley, Charmian A; Child, Christopher J; Kalifa, Gabriel; Deal, Cheri; Drop, Stenvert L S; Rappold, Gudrun; Cutler, Gordon B

2013-08-01

Growth impairment in short stature homeobox-containing gene (SHOX) deficiency and Turner syndrome share a similar etiology. Because of the established effect of GH treatment on height in patients with Turner syndrome, we hypothesized that GH therapy would also stimulate growth in patients with SHOX deficiency. Our objectives were to evaluate long-term efficacy of GH treatment in short patients with SHOX deficiency and to compare the effect on final (adult) height (FH) in patients with SHOX deficiency and Turner syndrome. A prospective, multinational, open-label, randomized 3-arm study consisting of a 2-year control period and a subsequent extension period to FH. The treatment groups were 1) SHOX-D-C/GH (untreated during the control period, GH-treated during the extension), 2) SHOX-D-GH/GH, and 3) Turner-GH/GH (GH-treated during both study periods). Short-statured prepubertal patients with genetically confirmed SHOX deficiency (n = 49) or Turner syndrome (n = 24) who participated in the extension. Depending on the study arm, patients received a daily sc injection of 0.05 mg/kg recombinant human GH from start of the study or start of the extension until attainment of FH or study closure. Height SD score gain from start of GH treatment to FH was similar between the combined SHOX-deficient groups (n = 28, 1.34 ± 0.18 [least-squares mean ± SE]) and the Turner group (n = 19, 1.32 ± 0.22). In this FH population, 57% of the patients with SHOX deficiency and 32% of the patients with Turner syndrome achieved a FH greater than -2 SD score. GH treatment in short children with SHOX deficiency showed similar long-term efficacy as seen in girls with Turner syndrome.

Eslicarbazepine acetate: its effectiveness as adjunctive therapy in clinical trials and open studies.

PubMed

Shorvon, S D; Trinka, E; Steinhoff, B J; Holtkamp, M; Villanueva, V; Peltola, J; Ben-Menachem, E

2017-03-01

Eslicarbazepine acetate (ESL) is a once-daily antiepileptic drug that is approved as adjunctive therapy in adults with focal-onset seizures. Following oral administration, ESL is rapidly metabolized to its active metabolite, eslicarbazepine, which acts primarily by enhancing slow inactivation of voltage-gated sodium channels. The efficacy and safety/tolerability of ESL in the adjunctive setting were established in a comprehensive Phase III program (n = 1702 randomized patients) and this evidence has been supported by several open studies (n = 864). ESL treatment has demonstrated improvements in health-related quality of life, in both randomized clinical trials and open studies. ESL has also been shown to be usually well tolerated and efficacious when used in the adjunctive setting in elderly patients. The effectiveness of ESL as the only add-on to antiepileptic drug monotherapy has been demonstrated in a multinational study (n = 219), subgroup analyses of which have also shown it to be efficacious and generally well tolerated in patients who had previously not responded to carbamazepine therapy. Open studies have also demonstrated improvements in tolerability in patients switched overnight from oxcarbazepine to ESL. Due to differences in pharmacokinetics, pharmacodynamics, and metabolism, there may be clinical situations in which it is appropriate to consider switching patients from oxcarbazepine or carbamazepine to ESL.

Construction of random sheared fosmid library from Chinese cabbage and its use for Brassica rapa genome sequencing project.

PubMed

Park, Tae-Ho; Park, Beom-Seok; Kim, Jin-A; Hong, Joon Ki; Jin, Mina; Seol, Young-Joo; Mun, Jeong-Hwan

2011-01-01

As a part of the Multinational Genome Sequencing Project of Brassica rapa, linkage group R9 and R3 were sequenced using a bacterial artificial chromosome (BAC) by BAC strategy. The current physical contigs are expected to cover approximately 90% euchromatins of both chromosomes. As the project progresses, BAC selection for sequence extension becomes more limited because BAC libraries are restriction enzyme-specific. To support the project, a random sheared fosmid library was constructed. The library consists of 97536 clones with average insert size of approximately 40 kb corresponding to seven genome equivalents, assuming a Chinese cabbage genome size of 550 Mb. The library was screened with primers designed at the end of sequences of nine points of scaffold gaps where BAC clones cannot be selected to extend the physical contigs. The selected positive clones were end-sequenced to check the overlap between the fosmid clones and the adjacent BAC clones. Nine fosmid clones were selected and fully sequenced. The sequences revealed two completed gap filling and seven sequence extensions, which can be used for further selection of BAC clones confirming that the fosmid library will facilitate the sequence completion of B. rapa. Copyright © 2011. Published by Elsevier Ltd.

Making metadata usable in a multi-national research setting.

PubMed

Ellul, Claire; Foord, Joanna; Mooney, John

2013-11-01

SECOA (Solutions for Environmental Contrasts in Coastal Areas) is a multi-national research project examining the effects of human mobility on urban settlements in fragile coastal environments. This paper describes the setting up of a SECOA metadata repository for non-specialist researchers such as environmental scientists and tourism experts. Conflicting usability requirements of two groups - metadata creators and metadata users - are identified along with associated limitations of current metadata standards. A description is given of a configurable metadata system designed to grow as the project evolves. This work is of relevance for similar projects such as INSPIRE. Copyright © 2012 Elsevier Ltd and The Ergonomics Society. All rights reserved.

Dependency, democracy, and infant mortality: a quantitative, cross-national analysis of less developed countries.

PubMed

Shandra, John M; Nobles, Jenna; London, Bruce; Williamson, John B

2004-07-01

This study presents quantitative, sociological models designed to account for cross-national variation in infant mortality rates. We consider variables linked to four different theoretical perspectives: the economic modernization, social modernization, political modernization, and dependency perspectives. The study is based on a panel regression analysis of a sample of 59 developing countries. Our preliminary analysis based on additive models replicates prior studies to the extent that we find that indicators linked to economic and social modernization have beneficial effects on infant mortality. We also find support for hypotheses derived from the dependency perspective suggesting that multinational corporate penetration fosters higher levels of infant mortality. Subsequent analysis incorporating interaction effects suggest that the level of political democracy conditions the effects of dependency relationships based upon exports, investments from multinational corporations, and international lending institutions. Transnational economic linkages associated with exports, multinational corporations, and international lending institutions adversely affect infant mortality more strongly at lower levels of democracy than at higher levels of democracy: intranational, political factors interact with the international, economic forces to affect infant mortality. We conclude with some brief policy recommendations and suggestions for the direction of future research.

Mipomersen sodium: first global approval.

PubMed

Hair, Philip; Cameron, Fiona; McKeage, Kate

2013-04-01

Mipomersen sodium (Kynamro™) (henceforth mipomersen) is a second-generation antisense oligonucleotide inhibitor of apolipoprotein B-100, which is the main structural component of atherogenic lipid particles. Mipomersen is administered via subcutaneous injection and is indicated as adjunctive treatment for homozygous familial hypercholesterolaemia (HoFH). The drug was developed by Isis Pharmaceuticals, which now collaborates with Genzyme Corporation for on-going development and product marketing. Multinational phase III trials of mipomersen as adjunctive therapy were completed in patients with HoFH, severe FH, heterozygous FH (HeFH) with coronary artery disease (CAD), and in those with hypercholesterolaemia at high risk of CAD. Mipomersen 200 mg once weekly has been approved in the USA as an adjunct to lipid-lowering medications and diet in HoFH patients and is undergoing regulatory review in the EU for the same indication. Genzyme is also conducting a multinational phase III, open-label extension study to evaluate long-term treatment in HoFH and HeFH patients, as well as a multinational trial to evaluate a three-times-per-week mipomersen regimen in patients with severe FH. This article summarises the milestones in the development of once-weekly, subcutaneous mipomersen leading to this first approval.

National Renewable Energy Policy in a Global World

NASA Astrophysics Data System (ADS)

Jeong, Minji

Increasing trade of renewable energy products has significantly contributed to reducing the costs of renewable energy sources, but at the same time, it has generated protectionist policies, which may negatively affect the trend of the cost reduction. Although a few recent studies examined the rise of renewable energy protectionism and trade disputes, they are limited in addressing the conflict between the original goal of traditional renewable energy policies and the new protectionist policies under the globalized renewable energy industry. To fill this gap, this dissertation explores how the globalized renewable energy industry has changed national renewable energy policies. Through three analyses, three aspects of the globalized renewable energy industry are examined: the rise of multinational corporations, international interactions among actors, and the changes of the global and domestic market conditions. First analysis investigates how multinational renewable energy corporations have affected national policies. A content analysis of the annual reports of 15 solar photovoltaic multinational corporation shows that solar multinationals have been influenced by national policies and have adapted to the changes rather than having attempted to change national policies. Second analysis examines how diverse actors have framed renewable energy trade issues through a network analysis of the Chinese solar panel issue in the United States. The result shows that the Chinese solar panel issue was framed differently from the traditional environmental frame of renewable energy, being dominated by multinational corporations headquartered in other countries. Third analysis explores what has caused the increasing diversity in national renewable energy policies through the case studies of the U.S. and South Korea. The result reveals that the globalization of solar industry has affected the diversification of solar policies in two countries by generating both challenges, which needed to be addressed by new and additional policies, and opportunities, which strengthened the political power of domestic solar industries. The three analyses show that the globalized renewable energy industry has led to the diversification of national renewable energy policies by increasing international interactions between actors and by introducing both challenges and opportunities to domestic renewable energy industries. This research contributes to the literature on trade and the environment by analyzing a new pattern of the conflicts between traditional environmental policies and "green" protectionist policies. It also contributes to the literature on protectionism by adding an empirical case of green protectionism, one of the forms of "murky" protectionism that has risen after the global financial crisis.

Politics of oil: multinational oil corporations and United States foreign policy, 1941-1954

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

Painter, D.S.

1982-01-01

The energy crises of the 1970s highlighted the importance of foreign oil to United States security and prosperity and focused attention on the relationship between multinational oil corporations and United States foreign policy. Important roots of present problems reach back to the period 1941 to 1954 when United States policymakers became aware that the nation's historic self-sufficiency in oil would soon come to an end. This realization led to plans to assure United States access to foreign oil reserves. During the early years of this period, the oil industry and its allies in congress defeated attempts by the government tomore » play an active role in foreign oil matters. With the government's role limited, the United States fell back to its traditional policy of supporting the foreign operations of United States corporations. Although this policy minimized government intervention in the internal operations of the oil industry, it nevertheless required the government to become actively involved in maintaining the security and stability of the Middle East and in working to contain economic nationalism in Latin America. Moreover, the policy resulted in the government acquiescing in private arrangements by the major companies to control the world oil economy. The most important factor shaping public policy on foreign oil was the overall hegemony of business in American society.« less

Dog rabies data reported to multinational organizations from Southern and Eastern African countries.

PubMed

Beyene, Tariku Jibat; Mourits, Monique C M; Hogeveen, Henk

2017-06-08

Rabies is one of the viral diseases with the highest case fatality rate in humans. The main transmission route to humans is through bites, especially of infected dogs. Decisions on the allocation of resources to control and reduce the socio-economic impacts of rabies require reliable data. Several national, regional and international organizations have been gathering rabies data for more than a decade. The objective of this paper was to examine the consistencies in the number of dog rabies cases reported to different multinational organizations by Southern and Eastern African countries and to explore the presence of any time trend among the reported rabies data. Data was systematically extracted from the databases of the Southern and Eastern African Rabies Group-SEARG and the World Organization for Animal Health/World animal health information-OIE/WAHID. Despite differences in entities by which data have been reported to the two organisations, reported numbers were significantly correlated (Spearman's rho = 0.52, P < 0.001). The reported data did not indicate the presence of any trend in the number of reported dog rabies outbreaks. Inconsistencies in the reported numbers were observed between the databases, possibly due to the fact that human and animal health authorities report separately to the organisations involved in addition to the use of indefinite definitions of report categories set by report receiving organizations.

The association between financial literacy and Problematic Internet Shopping in a multinational sample.

PubMed

Lam, Lawrence T; Lam, Mary K

2017-12-01

To examine the association between financial literacy and Problematic Internet Shopping in adults. This cross-sectional online survey recruited participants, aged between 18 and 60 years, through an online research facility. The sample consisted of multinational participants from mainly three continents including Europe, North America, and Asia. Problematic Internet Shopping was assessed using the Bergen Shopping Addiction Scale (BSAS). Financial Literacy was measured by the Financial Literacy subscale of the Financial Wellbeing Questionnaire. Multiple linear regression analyses were conducted to elucidate the relationship between the study and outcome variables with adjustment for other potential risk factors. Of the total of 997 respondents with an average age of 30.9 (s.d. = 8.8), 135 (13.8%) could be classified as having a high risk of being Problematic Internet Shoppers. Results from the multiple regression analyses suggested a significant and negative relationship between financial literacy and Problematic Internet Shopping with a regression coefficient of - 0.13, after controlling for the effects of potential risk factors such as age, region of birth, employment, income, shopping frequency, self-regulation and anxiety (t = - 6.42, p < 0.001). The clinical management of PIS should include a financial counselling as a component of the treatment regime. Enhancement of financial literacy in the general population, particularly among young people, will likely have a positive effect on the occurrence of PIS.

Results from a large multinational clinical trial (guardian™1) using prophylactic treatment with turoctocog alfa in adolescent and adult patients with severe haemophilia A: safety and efficacy.

PubMed

Lentz, S R; Misgav, M; Ozelo, M; Salek, S Z; Veljkovic, D; Recht, M; Cerqueira, M; Tiede, A; Brand, B; Mancuso, M E; Seremetis, S; Lindblom, A; Martinowitz, U

2013-09-01

Recombinant factor VIII (rFVIII) products provide a safe and efficacious replacement therapy for prophylaxis and treatment of bleeding episodes in patients with severe haemophilia A. This multinational, open-label, non-controlled trial investigated the safety and efficacy of turoctocog alfa, a new rFVIII product. The primary objective was to evaluate safety. A total of 150 patients (24 adolescents and 126 adults) with severe haemophilia A (FVIII activity ≤ 1%), with at least 150 exposure days (EDs) to any FVIII product and no history of inhibitors were enrolled, and 146 patients (97%) completed the trial. All patients received prophylaxis with turoctocog alfa for approximately 6 months and had a mean of 85 EDs during the trial. None of the patients developed FVIII inhibitors, there were no indications of early FVIII inhibitor development and no safety concerns were identified. A total of 225 adverse events were reported in 100 (67%) patients, with the most common being events associated with dosing procedures, headaches, and nasopharyngitis. A total of 499 bleeding episodes were reported during the trial, the majority (89%) were controlled with 1-2 infusions of turoctocog alfa. Based on patient reports, the success rate (defined as 'excellent' or 'good' haemostatic response) for treatment of bleeding episodes was 81%. The overall median annualized bleeding rate was 3.7 (interquartile range: 8.7) bleeds/patient/year. In conclusion, turoctocog alfa provides a new, safe and effective alternative for prophylaxis and treatment of bleeding episodes in patients with haemophilia A. © 2013 John Wiley & Sons Ltd.

Relationship between angina pectoris and outcomes in patients with heart failure and reduced ejection fraction: an analysis of the Controlled Rosuvastatin Multinational Trial in Heart Failure (CORONA).

PubMed

Badar, Athar A; Perez-Moreno, Ana Cristina; Jhund, Pardeep S; Wong, Chih M; Hawkins, Nathaniel M; Cleland, John G F; van Veldhuisen, Dirk J; Wikstrand, John; Kjekshus, John; Wedel, Hans; Watkins, Stuart; Gardner, Roy S; Petrie, Mark C; McMurray, John J V

2014-12-21

Angina pectoris is common in patients with heart failure and reduced ejection fraction (HF-REF) but its relationship with outcomes has not been well defined. This relationship was investigated further in a retrospective analysis of the Controlled Rosuvastatin Multinational Trial in Heart Failure (CORONA). Four thousand, eight hundred and seventy-eight patients were divided into three categories: no history of angina and no chest pain at baseline (Group A; n = 1240), past history of angina but no chest pain at baseline (Group B; n = 1353) and both a history of angina and chest pain at baseline (Group C; n = 2285). Outcomes were examined using Kaplan-Meier and Cox regression survival analysis. Compared with Group A, Group C had a higher risk of non-fatal myocardial infarction or unstable angina (HR: 2.36, 1.54-3.61; P < 0.001), this composite plus coronary revascularization (HR: 2.54, 1.76-3.68; P < 0.001), as well as HF hospitalization (HR: 1.35, 1.13-1.63; P = 0.001), over a median follow-up period of 33 months. There was no difference in cardiovascular or all-cause mortality. Group B had a smaller increase in risk of coronary events but not of heart failure hospitalization. Patients with HF-REF and ongoing angina are at an increased risk of acute coronary syndrome and HF hospitalization. Whether these patients would benefit from more aggressive medical therapy or percutaneous revascularization is not known and merits further investigation. Published on behalf of the European Society of Cardiology. All rights reserved. © The Author 2014. For permissions please email: journals.permissions@oup.com.

Effects of acetyl-DL-leucine on cerebellar ataxia (ALCAT trial): study protocol for a multicenter, multinational, randomized, double-blind, placebo-controlled, crossover phase III trial.

PubMed

Feil, Katharina; Adrion, Christine; Teufel, Julian; Bösch, Sylvia; Claassen, Jens; Giordano, Ilaria; Hengel, Holger; Jacobi, Heike; Klockgether, Thomas; Klopstock, Thomas; Nachbauer, Wolfgang; Schöls, Ludger; Stendel, Claudia; Uslar, Ellen; van de Warrenburg, Bart; Berger, Ingrid; Naumann, Ivonne; Bayer, Otmar; Müller, Hans-Helge; Mansmann, Ulrich; Strupp, Michael

2017-01-10

Cerebellar ataxia (CA) is a frequent and often disabling condition that impairs motor functioning and impacts on quality of life (QoL). No medication has yet been proven effective for the symptomatic or even causative treatment of hereditary or non-hereditary, non-acquired CA. So far, the only treatment recommendation is physiotherapy. Therefore, new therapeutic options are needed. Based on three observational studies, the primary objective of the acetyl-DL-leucine on ataxia (ALCAT) trial is to examine the efficacy and tolerability of a symptomatic therapy with acetyl-DL-leucine compared to placebo on motor function measured by the Scale for the Assessment and Rating of Ataxia (SARA) in patients with CA. An investigator-initiated, multicenter, European, randomized, double-blind, placebo-controlled, 2-treatment 2-period crossover phase III trial will be carried out. In total, 108 adult patients who meet the clinical criteria of CA of different etiologies (hereditary or non-hereditary, non-acquired) presenting with a SARA total score of at least 3 points will be randomly assigned in a 1:1 ratio to one of two different treatment sequences, either acetyl-DL-leucine (up to 5 g per day) followed by placebo or vice versa. Each sequence consists of two 6-week treatment periods, separated by a 4-week wash-out period. A follow-up examination is scheduled 4 weeks after the end of treatment. The primary efficacy outcome is the absolute change in the SARA total score. Secondary objectives are to demonstrate that acetyl-DL-leucine is effective in improving (1) motor function measured by the Spinocerebellar Ataxia Functional Index (SCAFI) and SARA subscore items and (2) QoL (EuroQoL 5 dimensions and 5 level version, EQ-5D-5 L), depression (Beck Depression Inventory, BDI-II) and fatigue (Fatigue Severity Score, FSS). Furthermore, the incidence of adverse events will be investigated. The results of this trial will inform whether symptomatic treatment with the modified amino-acid acetyl-DL-leucine is a worthy candidate for a new drug therapy to relieve ataxia symptoms and to improve patient care. If superiority of the experimental drug to placebo can be established it will also be re-purposing of an agent that has been previously used for the symptomatic treatment of dizziness. The trial was prospectively registered at www.clinicaltrialsregister.eu (EudraCT no. 2015-000460-34) and at https://www.germanctr.de (DRKS-ID: DRKS00009733 ).

Evaluation of the safety and efficacy of an edoxaban-based antithrombotic regimen in patients with atrial fibrillation following successful percutaneous coronary intervention (PCI) with stent placement: Rationale and design of the ENTRUST-AF PCI trial.

PubMed

Vranckx, Pascal; Lewalter, Thorsten; Valgimigli, Marco; Tijssen, Jan G; Reimitz, Paul-Egbert; Eckardt, Lars; Lanz, Hans-Joachim; Zierhut, Wolfgang; Smolnik, Rüdiger; Goette, Andreas

2018-02-01

The optimal antithrombotic treatment after percutaneous coronary intervention (PCI) with stenting in patients with atrial fibrillation (AF) is unknown. In the ENGAGE AF-TIMI 48 trial, edoxaban was noninferior to a vitamin K antagonist (VKA) with respect to the prevention of stroke or systemic embolism and was associated with significantly lower rates of bleeding and cardiovascular death in patients with nonvalvular AF. The effects of edoxaban in combination with single- or dual-antiplatelet therapy in the setting of PCI are unexplored. The ENTRUST-AF PCI trial is a multinational, multicenter, randomized, open-label phase 3b trial with blinded end point evaluation involving 1,500 patients on oral anticoagulation for AF. Patients are randomized between 4 hours and 5 days after successful PCI to either an edoxaban-based strategy (experimental arm; 60 mg [or 30 mg according to dose reduction criteria] once daily plus a P2Y 12 antagonist [default clopidogrel, 75 mg once daily] for 12 months) or a VKA-based strategy (control arm; VKA plus a P2Y 12 antagonist [as above] plus acetylsalicylic acid [100 mg once daily] for 30 days to 12 months). The primary safety end point is the incidence of International Society on Thrombosis and Haemostasis-defined major or clinically relevant nonmajor bleeding. The main efficacy end point is the composite of cardiovascular death, stroke, systemic embolic events, spontaneous myocardial infarction, and definite stent thrombosis. The ENTRUST-AF PCI trial tests the hypothesis that an edoxaban-based antithrombotic strategy reduces the risk of bleeding complications after PCI compared with VKA plus conventional dual-antiplatelet therapy in patients with AF in need of oral anticoagulation. The relative risk of ischemic events between groups will be compared. Copyright © 2017 The Authors. Published by Elsevier Inc. All rights reserved.

Extracorporeal cellular therapy (ELAD) in severe alcoholic hepatitis: A multinational, prospective, controlled, randomized trial

PubMed Central

Thompson, Julie; Jones, Natasha; Al‐Khafaji, Ali; Malik, Shahid; Reich, David; Munoz, Santiago; MacNicholas, Ross; Hassanein, Tarek; Teperman, Lewis; Stein, Lance; Duarte‐Rojo, Andrés; Malik, Raza; Adhami, Talal; Asrani, Sumeet; Shah, Nikunj; Gaglio, Paul; Duddempudi, Anupama; Borg, Brian; Jalan, Rajiv; Brown, Robert; Patton, Heather; Satoskar, Rohit; Rossi, Simona; Parikh, Amay; ElSharkawy, Ahmed; Mantry, Parvez; Sher, Linda; Wolf, David; Hart, Marquis; Landis, Charles; Wigg, Alan; Habib, Shahid; McCaughan, Geoffrey; Colquhoun, Steven; Henry, Alyssa; Bedard, Patricia; Landeen, Lee; Millis, Michael; Ashley, Robert; Frank, William; Henry, Andrew; Subramanian, Ram

2018-01-01

Severe alcoholic hepatitis (sAH) is associated with a poor prognosis. There is no proven effective treatment for sAH, which is why early transplantation has been increasingly discussed. Hepatoblastoma‐derived C3A cells express anti‐inflammatory proteins and growth factors and were tested in an extracorporeal cellular therapy (ELAD) study to establish their effect on survival for subjects with sAH. Adults with sAH, bilirubin ≥8 mg/dL, Maddrey's discriminant function ≥ 32, and Model for End‐Stage Liver Disease (MELD) score ≤ 35 were randomized to receive standard of care (SOC) only or 3‐5 days of continuous ELAD treatment plus SOC. After a minimum follow‐up of 91 days, overall survival (OS) was assessed by using a Kaplan‐Meier survival analysis. A total of 203 subjects were enrolled (96 ELAD and 107 SOC) at 40 sites worldwide. Comparison of baseline characteristics showed no significant differences between groups and within subgroups. There was no significant difference in serious adverse events between the 2 groups. In an analysis of the intent‐to‐treat population, there was no difference in OS (51.0% versus 49.5%). The study failed its primary and secondary end point in a population with sAH and with a MELD ranging from 18 to 35 and no upper age limit. In the prespecified analysis of subjects with MELD < 28 (n = 120), ELAD was associated with a trend toward higher OS at 91 days (68.6% versus 53.6%; P = .08). Regression analysis identified high creatinine and international normalized ratio, but not bilirubin, as the MELD components predicting negative outcomes with ELAD. A new trial investigating a potential benefit of ELAD in younger subjects with sufficient renal function and less severe coagulopathy has been initiated. Liver Transplantation 24 380–393 2018 AASLD. PMID:29171941

Design and rationale for the Cardiovascular and Metabolic Effects of Lorcaserin in Overweight and Obese Patients-Thrombolysis in Myocardial Infarction 61 (CAMELLIA-TIMI 61) trial.

PubMed

Bohula, Erin A; Scirica, Benjamin M; Fanola, Christina; Inzucchi, Silvio E; Keech, Anthony; McGuire, Darren K; Smith, Steven R; Abrahamsen, Tim; Francis, Bruce H; Miao, Wenfeng; Perdomo, Carlos A; Satlin, Andrew; Wiviott, Stephen D; Sabatine, Marc S

2018-03-29

Lorcaserin, a selective serotonin 2C receptor agonist, is an effective pharmacologic weight-loss therapy that improves several cardiovascular risk factors. The long-term clinical cardiovascular and metabolic safety and efficacy in patients with elevated cardiovascular risk are unknown. CAMELLIA-TIMI 61 (NCT02019264) is a randomized, double-blind, placebo-controlled, multinational clinical trial designed to evaluate the safety and efficacy of lorcaserin with regard to major adverse cardiovascular events and progression to diabetes in overweight or obese patients at high cardiovascular risk. Overweight or obese patients either with established cardiovascular disease or with diabetes and at least 1 other cardiovascular risk factor were randomized in a 1:1 ratio to lorcaserin 10 mg twice daily or matching placebo. The primary safety objective is to assess for noninferiority of lorcaserin for the composite end point of cardiovascular death, myocardial infarction, or stroke (major adverse cardiovascular event [MACE]) (with noninferiority defined as the upper bound of a 1-sided 97.5% CI excluding a hazard ratio of 1.4) compared with placebo assessed at an interim analysis with 460 adjudicated events. The efficacy objectives, assessed at study completion, will evaluate the superiority of lorcaserin for the primary composite end point of cardiovascular death, myocardial infarction, stroke, hospitalization for unstable angina, heart failure, or any coronary revascularization (MACE+) and the key secondary end point of conversion to diabetes. Recruitment began in January 2014 and was completed in November 2015 resulting in a total population of 12,000 patients. The trial is planned to continue until at least 1,401 adjudicated MACE+ events are accrued and the median treatment duration exceeds 2.5 years. CAMELLIA-TIMI 61 is investigating the safety and efficacy of lorcaserin for MACEs and conversion to diabetes in overweight or obese patients with established cardiovascular disease or multiple cardiovascular risk factors. Copyright © 2018. Published by Elsevier Inc.

Leveraging ongoing research to evaluate the health impacts of South Africa's salt reduction strategy: a prospective nested cohort within the WHO-SAGE multicountry, longitudinal study

PubMed Central

Charlton, Karen; Menyanu, Elias; Biritwum, Richard Berko; Naidoo, Nirmala; Pieterse, Chiné; Madurai, Savathree (Lorna); Baumgartner, Jeannine; Asare, George A; Thiele, Elizabeth; Schutte, Aletta E; Kowal, Paul

2016-01-01

Introduction Attempting to curb the rising epidemic of hypertension, South Africa implemented legislation in June 2016 mandating maximum sodium levels in a range of manufactured foods that contribute significantly to population salt intake. This natural experiment, comparing two African countries with and without salt legislation, will provide timely information on the impact of legislative approaches addressing the food supply to improve blood pressure in African populations. This article outlines the design of this ongoing prospective nested cohort study. Methods and analysis Baseline sodium intake was assessed in a nested cohort of the WHO Study on global AGEing and adult health (WHO-SAGE) wave 2 (2014–2015), a multinational longitudinal study on the health and well-being of adults and the ageing process. The South African cohort consisted of randomly selected households (n=4030) across the country. Spot and 24-hour urine samples are collected in a random subsample (n=1200) and sodium, potassium, creatinine and iodine analysed. Salt behaviour and sociodemographic data are captured using face-to-face interviews, alongside blood pressure and anthropometric measures. Ghana, the selected control country with no formal salt policy, provided a nested subsample (n=1200) contributing spot and 24-hour urine samples from the SAGE Ghana cohort (n=5000). Follow-up interviews and urine collection (wave 3) in both countries will take place in 2017 (postlegislation) to assess change in population-level sodium intake and blood pressure. Ethics and dissemination SAGE was approved by the WHO Ethics Review Committee (reference number RPC149) with local approval from the North-West University Human Research Ethics Committee and University of the Witwatersrand Human Research Ethics Committee (South Africa), and University of Ghana Medical School Ethics and Protocol Review Committee (Ghana). The results of the study will be published in peer-reviewed international journals, presented at national and international conferences, and summarised as research and policy briefs. PMID:27903563

Obesity, diet quality and absenteeism in a working population.

PubMed

Fitzgerald, Sarah; Kirby, Ann; Murphy, Aileen; Geaney, Fiona

2016-12-01

The relationship between workplace absenteeism and adverse lifestyle factors (smoking, physical inactivity and poor dietary patterns) remains ambiguous. Reliance on self-reported absenteeism and obesity measures may contribute to this uncertainty. Using objective absenteeism and health status measures, the present study aimed to investigate what health status outcomes and lifestyle factors influence workplace absenteeism. Cross-sectional data were obtained from a complex workplace dietary intervention trial, the Food Choice at Work Study. Four multinational manufacturing workplaces in Cork, Republic of Ireland. Participants included 540 randomly selected employees from the four workplaces. Annual count absenteeism data were collected. Physical assessments included objective health status measures (BMI, midway waist circumference and blood pressure). FFQ measured diet quality from which DASH (Dietary Approaches to Stop Hypertension) scores were constructed. A zero-inflated negative binomial (zinb) regression model examined associations between health status outcomes, lifestyle characteristics and absenteeism. The mean number of absences was 2·5 (sd 4·5) d. After controlling for sociodemographic and lifestyle characteristics, the zinb model indicated that absenteeism was positively associated with central obesity, increasing expected absence rate by 72 %. Consuming a high-quality diet and engaging in moderate levels of physical activity were negatively associated with absenteeism and reduced expected frequency by 50 % and 36 %, respectively. Being in a managerial/supervisory position also reduced expected frequency by 50 %. To reduce absenteeism, workplace health promotion policies should incorporate recommendations designed to prevent and manage excess weight, improve diet quality and increase physical activity levels of employees.

Multinational Experiment 7. Outcome 3 - Cyber Domain Objective 3.1: Threats and Vulnerability Methodology Version 1.0

DTIC Science & Technology

2014-02-09

often  operators  of command and control  systems  within critical infrastructures, and  can in some ways be considered critical assets themselves. The...application layer makes up the  command and control  system  for the critical infrastructure. That includes  operating   systems  and  applications for users and...Determine how to achieve secure synchronization between primary and secondary  systems .  • Ensure alternatives are  operating , trained for, and practiced

Multinational Alcohol Market Development and Public Health: Diageo in India.

PubMed

Esser, Marissa B; Jernigan, David H

2015-11-01

Alcohol is a risk factor for communicable and noncommunicable diseases, and alcohol consumption is rising steadily in India. The growth of multinational alcohol corporations, such as Diageo, contributes to India's changing alcohol environment. We provide a brief history of India's alcohol regulation for context and examine Diageo's strategies for expansion in India in 2013 and 2014. Diageo is attracted to India's younger generation, women, and emerging middle class for growth opportunities. Components of Diageo's responsibility strategy conflict with evidence-based public health recommendations for reducing harmful alcohol consumption. Diageo's strategies for achieving market dominance in India are at odds with public health evidence. We conclude with recommendations for protecting public health in emerging markets.

Barriers to the conduct of randomised clinical trials within all disease areas.

PubMed

Djurisic, Snezana; Rath, Ana; Gaber, Sabrina; Garattini, Silvio; Bertele, Vittorio; Ngwabyt, Sandra-Nadia; Hivert, Virginie; Neugebauer, Edmund A M; Laville, Martine; Hiesmayr, Michael; Demotes-Mainard, Jacques; Kubiak, Christine; Jakobsen, Janus C; Gluud, Christian

2017-08-01

Randomised clinical trials are key to advancing medical knowledge and to enhancing patient care, but major barriers to their conduct exist. The present paper presents some of these barriers. We performed systematic literature searches and internal European Clinical Research Infrastructure Network (ECRIN) communications during face-to-face meetings and telephone conferences from 2013 to 2017 within the context of the ECRIN Integrating Activity (ECRIN-IA) project. The following barriers to randomised clinical trials were identified: inadequate knowledge of clinical research and trial methodology; lack of funding; excessive monitoring; restrictive privacy law and lack of transparency; complex regulatory requirements; and inadequate infrastructures. There is a need for more pragmatic randomised clinical trials conducted with low risks of systematic and random errors, and multinational cooperation is essential. The present paper presents major barriers to randomised clinical trials. It also underlines the value of using a pan-European-distributed infrastructure to help investigators overcome barriers for multi-country trials in any disease area.

Fourth Collaborative Materials Exercise of the Nuclear Forensics International Technical Working Group

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

Schwantes, J. M.; Marsden, O.; Reilly, D.

Abstract The Nuclear Forensics International Technical Working Group is a community of nuclear forensic practitioners who respond to incidents involving nuclear and other radioactive material out of regulatory control. The Group is dedicated to advancing nuclear forensic science in part through periodic participation in materials exercises. The Group completed its fourth Collaborative Materials Exercise in 2015 in which laboratories from 15 countries and one multinational organization analyzed three samples of special nuclear material in support of a mock nuclear forensic investigation. This special section of the Journal for Radioanalytical and Nuclear Chemistry is devoted to summarizing highlights from this exercise.

Chemical ecology: studies from East Africa.

PubMed

Meinwald, J; Prestwich, G D; Nakanishi, K; Kubo, I

1978-03-17

The International Centre of Insect Physiology and Ecology (ICIPE), in Nairobi, provides a laboratory at which a multinational group of scientists pursues interdisciplinary research. In collaboration with their colleagues in biology, ICIPE chemists have characterized the sex pheromones of the tick which serves as a vector of East Coast fever and have identified a termite queen-cell-building pheromone. The structure of many anthropod defensive chemicals have been determined; most interesting of these are the trinervitenes, structurally novel diterpenoids from nasute termites. Several highly active insect antifeedants were discovered using a simple bioassay to screen selected East African plants. These antifeedants may provide leads for the development of new insect-control techniques.

Estrogen receptor and progesterone receptor as predictive biomarkers of response to endocrine therapy: a prospectively powered pathology study in the Tamoxifen and Exemestane Adjuvant Multinational trial.

PubMed

Bartlett, John M S; Brookes, Cassandra L; Robson, Tammy; van de Velde, Cornelis J H; Billingham, Lucinda J; Campbell, Fiona M; Grant, Margaret; Hasenburg, Annette; Hille, Elysée T M; Kay, Charlene; Kieback, Dirk G; Putter, Hein; Markopoulos, Christos; Kranenbarg, Elma Meershoek-Klein; Mallon, Elizabeth A; Dirix, Luc; Seynaeve, Caroline; Rea, Daniel

2011-04-20

The Tamoxifen and Exemestane Adjuvant Multinational (TEAM) trial included a prospectively planned pathology substudy testing the predictive value of progesterone receptor (PgR) expression for outcome of estrogen receptor-positive (ER-positive) early breast cancer treated with exemestane versus tamoxifen. Pathology blocks from 4,781 TEAM patients randomly assigned to exemestane versus tamoxifen followed by exemestane for 5 years of total therapy were collected centrally, and tissue microarrays were constructed from samples from 4,598 patients. Quantitative analysis of hormone receptors (ER and PgR) was performed by using image analysis and immunohistochemistry, and the results were linked to outcome data from the main TEAM trial and analyzed relative to disease-free survival and treatment. Of 4,325 eligible ER-positive patients, 23% were PgR-poor (Allred < 4) and 77% were PgR- rich (Allred ≥ 5). No treatment-by-marker effect for PgR was observed for exemestane versus tamoxifen (PgR-rich hazard ratio [HR], 0.83; 95% CI, 0.65 to 1.05; PgR-poor HR, 0.85; 95% CI, 0.61 to 1.19; P = .88 for interaction). Both PgR and ER expression were associated with patient prognosis in univariate (PgR HR, 0.53; 95% CI, 0.43 to 0.65; P < .001; ER HR, 0.66; 95% CI, 0.51 to 0.86; P = .002), and multivariate analyses (P < .001 and P = .001, respectively). A trend toward a treatment-by-marker effect for ER-rich patients was observed. Preferential exemestane versus tamoxifen treatment benefit was not predicted by PgR expression; conversely, patients with ER-rich tumors may derive additional benefit from exemestane. Quantitative analysis of ER and PgR expression provides highly significant information on risk of early relapse (within 1 to 3 years) during treatment.

Estrogen Receptor and Progesterone Receptor As Predictive Biomarkers of Response to Endocrine Therapy: A Prospectively Powered Pathology Study in the Tamoxifen and Exemestane Adjuvant Multinational Trial

PubMed Central

Bartlett, John M.S.; Brookes, Cassandra L.; Robson, Tammy; van de Velde, Cornelis J.H.; Billingham, Lucinda J.; Campbell, Fiona M.; Grant, Margaret; Hasenburg, Annette; Hille, Elysée T.M.; Kay, Charlene; Kieback, Dirk G.; Putter, Hein; Markopoulos, Christos; Kranenbarg, Elma Meershoek-Klein; Mallon, Elizabeth A.; Dirix, Luc; Seynaeve, Caroline; Rea, Daniel

2011-01-01

Purpose The Tamoxifen and Exemestane Adjuvant Multinational (TEAM) trial included a prospectively planned pathology substudy testing the predictive value of progesterone receptor (PgR) expression for outcome of estrogen receptor–positive (ER-positive) early breast cancer treated with exemestane versus tamoxifen. Patients and Methods Pathology blocks from 4,781 TEAM patients randomly assigned to exemestane versus tamoxifen followed by exemestane for 5 years of total therapy were collected centrally, and tissue microarrays were constructed from samples from 4,598 patients. Quantitative analysis of hormone receptors (ER and PgR) was performed by using image analysis and immunohistochemistry, and the results were linked to outcome data from the main TEAM trial and analyzed relative to disease-free survival and treatment. Results Of 4,325 eligible ER-positive patients, 23% were PgR-poor (Allred < 4) and 77% were PgR- rich (Allred ≥ 5). No treatment-by-marker effect for PgR was observed for exemestane versus tamoxifen (PgR-rich hazard ratio [HR], 0.83; 95% CI, 0.65 to 1.05; PgR-poor HR, 0.85; 95% CI, 0.61 to 1.19; P = .88 for interaction). Both PgR and ER expression were associated with patient prognosis in univariate (PgR HR, 0.53; 95% CI, 0.43 to 0.65; P < .001; ER HR, 0.66; 95% CI, 0.51 to 0.86; P = .002), and multivariate analyses (P < .001 and P = .001, respectively). A trend toward a treatment-by-marker effect for ER-rich patients was observed. Conclusion Preferential exemestane versus tamoxifen treatment benefit was not predicted by PgR expression; conversely, patients with ER-rich tumors may derive additional benefit from exemestane. Quantitative analysis of ER and PgR expression provides highly significant information on risk of early relapse (within 1 to 3 years) during treatment. PMID:21422407

Specific adverse events predict survival benefit in patients treated with tamoxifen or aromatase inhibitors: an international tamoxifen exemestane adjuvant multinational trial analysis.

PubMed

Fontein, Duveken B Y; Seynaeve, Caroline; Hadji, Peyman; Hille, Elysée T M; van de Water, Willemien; Putter, Hein; Kranenbarg, Elma Meershoek-Klein; Hasenburg, Annette; Paridaens, Robert J; Vannetzel, Jean-Michel; Markopoulos, Christos; Hozumi, Yasuo; Bartlett, John M S; Jones, Stephen E; Rea, Daniel William; Nortier, Johan W R; van de Velde, Cornelis J H

2013-06-20

Specific adverse events (AEs) associated with endocrine therapy and related to depletion or blocking of circulating estrogens may be related to treatment efficacy. We investigated the relationship between survival outcomes and specific AEs including vasomotor symptoms (VMSs), musculoskeletal adverse events (MSAEs), and vulvovaginal symptoms (VVSs) in postmenopausal patients with breast cancer participating in the international Tamoxifen Exemestane Adjuvant Multinational (TEAM) trial. Primary efficacy end points were disease-free survival (DFS), overall survival (OS), and distant metastases (DM). VMSs, MSAEs, and VVSs arising in the first year of endocrine treatment were considered. Patients who did not start or who discontinued their allocated therapy and/or had an event (recurrence/death) within 1 year after randomization were excluded. Landmark analyses and time-dependent multivariate Cox proportional hazards models assessed survival differences up to 5 years from the start of treatment. A total of 9,325 patients were included. Patients with specific AEs (v nonspecific or no AEs) had better DFS and OS (multivariate hazard ratio [HR] for DFS: VMSs, 0.731 [95% CI, 0.618 to 0.866]; MSAEs, 0.826 [95% CI, 0.694 to 0.982]; VVSs, 0.769 [95% CI, 0.585 to 1.01]; multivariate HR for OS: VMSs, 0.583 [95% CI, 0.424 to 0.803]; MSAEs, 0.811 [95% CI, 0.654 to 1.005]; VVSs, 0.570 [95% CI, 0.391 to 0.831]) and fewer DM (VMSs, 0.813 [95% CI, 0.664 to 0.996]; MSAEs, 0.749 [95% CI, 0.601 to 0.934]; VVSs, 0.687 [95% CI, 0.436 to 1.085]) than patients not reporting these symptoms. Increasing numbers of specific AEs were also associated with better survival outcomes. Outcomes were unrelated to treatment allocation. Certain specific AEs are associated with superior survival outcomes and may therefore be useful in predicting treatment responses in patients with breast cancer treated with endocrine therapy.

Theory of bargaining between multinational corporations and developing countries over mineral and petroleum-extraction contracts

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

King, P.G.

1987-01-01

The history of negotiations between multinational corporations and less-developed countries involved in mineral and petroleum extraction has been widely examined. Virtually all case studies of the history of negotiations over these contracts demonstrate that, over time, the contracts tend to be renegotiated on terms more favorable to the developing country. This thesis begins by examining three case studies of negotiations between Third World countries and mineral or petroleum extracting multinational corporations: bauxite in Jamaica, petroleum in Indonesia, and copper in Chile. Evidence is presented to demonstrate that the history of negotiations in Jamaica and Indonesia is inconsistent with the oftenmore » cited theory (Morgan (1975)) that the LDC's increase in profit-share stems from the country's development of negotiating, supervisory, and operating skills. However, in all of these case studies, renegotiations often took place when the country was experiencing an economic or political crisis. The contract renegotiations appear to be an (often successful) attempt by the ruling regime to maintain power. Another aspect of mineral and petroleum extraction is that investment tends to be lumpy. Typically, mineral and petroleum extraction involves an enormous initial investment within the sovereign territory of the LDC, generally financed by the MNC.« less

Results of an International Space Crew Debrief

NASA Technical Reports Server (NTRS)

Santy, P. A.; Holland, A. W.; Looper, L.; Marcondes-North, R.

1992-01-01

In order to identify potential multi-cultural and multinational problems for future International Space Station Freedom crew, a crew debrief questionnaire was developed for U.S. astronauts who flew on shuttle missions with one or more crew members from other countries. Methods: From 1981-90, a total of 20 U.S. astronauts flew on international space missions. Debriefs were mailed to all 20 with instructions not to identify themselves or their specific mission. The debrief focused primarily on preflight training and post flight incidents of misunderstanding, miscommunication, and interpersonal friction among crewmembers. Astronauts were also asked to rate the impact of the incident to the mission (low, medium, high). Results: Ten astronauts responded, but only nine responses were able to be scored, for a return rate of 45 percent. 42 incidents were reported, 9 in the preflight period, 26 inflight, and 7 in the postflight period. Most of the incidents were rated at a low or medium impact, but 5 of the inflight incidents were rated at a 'high' mission impact. A number of causes for the problems were listed, and are discussed. Conclusions: The debrief respondents provide useful and timely recommendations on preflight training which might help facilitate the integration of multinational crews and prevent multi-cultural or multinational factors from interfering with mission operations.

Contact sensitizers in commercial hair dye products sold in Thailand.

PubMed

Boonchai, Waranya; Bunyavaree, Monthathip; Winayanuwattikun, Waranaree; Kasemsarn, Pranee

2016-04-01

Hair dyes are known to contain potent contact allergens for which sensitization rates have increased over the last decade. To examine the type and frequency of potent contact sensitizers labelled on hair dyes sold in metropolitan Bangkok, Thailand. During the 2013-2014 study period, labelled ingredient information from home use and professional hair dye products was collected. Two hundred and fifty-two hair dye products were evaluated. One hundred and forty-nine products from 48 brands were domestically produced in Thailand, and 103 products were from 23 multinational brands produced in countries other than Thailand. Two hundred and fourteen of 252 (84.9%) hair dye products were found to contain strong skin sensitizers, with 118 (46.8%) being found in domestically produced products, and 96 (38.1%) being found in multinational brand products. Thirty-eight hair dye products (15.1%) were free of potent skin sensitizers. The number of domestically produced products (31, 20.8%) that were free of potent skin sensitizers was significantly higher (p = 0.002) than the number of multinational brand products (7, 6.8%). p-Phenylenediamine was the most prevalent potent sensitizer found among domestically produced hair dyes available on the market. Our findings indicate regional differences in hair dye allergen exposure. © 2016 John Wiley & Sons A/S. Published by John Wiley & Sons Ltd.

A survey of national and multi-national registries and cohort studies in juvenile idiopathic arthritis: challenges and opportunities.

PubMed

Beukelman, Timothy; Anink, Janneke; Berntson, Lillemor; Duffy, Ciaran; Ellis, Justine A; Glerup, Mia; Guzman, Jaime; Horneff, Gerd; Kearsley-Fleet, Lianne; Klein, Ariane; Klotsche, Jens; Magnusson, Bo; Minden, Kirsten; Munro, Jane E; Niewerth, Martina; Nordal, Ellen; Ruperto, Nicolino; Santos, Maria Jose; Schanberg, Laura E; Thomson, Wendy; van Suijlekom-Smit, Lisette; Wulffraat, Nico; Hyrich, Kimme

2017-04-19

To characterize the existing national and multi-national registries and cohort studies in juvenile idiopathic arthritis (JIA) and identify differences as well as areas of potential future collaboration. We surveyed investigators from North America, Europe, and Australia about existing JIA cohort studies and registries. We excluded cross-sectional studies. We captured information about study design, duration, location, inclusion criteria, data elements and collection methods. We received survey results from 18 studies, including 11 national and 7 multi-national studies representing 37 countries in total. Study designs included inception cohorts, prevalent disease cohorts, and new treatment cohorts (several of which contribute to pharmacosurveillance activities). Despite numerous differences, the data elements collected across the studies was quite similar, with most studies collecting at least 5 of the 6 American College of Rheumatology core set variables and the data needed to calculate the 3-variable clinical juvenile disease activity score. Most studies were collecting medication initiation and discontinuation dates and were attempting to capture serious adverse events. There is a wide-range of large, ongoing JIA registries and cohort studies around the world. Our survey results indicate significant potential for future collaborative work using data from different studies and both combined and comparative analyses.

Mind the Gap! A Multilevel Analysis of Factors Related to Variation in Published Cost-Effectiveness Estimates within and between Countries

PubMed Central

Boehler, Christian E. H.; Lord, Joanne

2016-01-01

Background. Published cost-effectiveness estimates can vary considerably, both within and between countries. Despite extensive discussion, little is known empirically about factors relating to these variations. Objectives. To use multilevel statistical modeling to integrate cost-effectiveness estimates from published economic evaluations to investigate potential causes of variation. Methods. Cost-effectiveness studies of statins for cardiovascular disease prevention were identified by systematic review. Estimates of incremental costs and effects were extracted from reported base case, sensitivity, and subgroup analyses, with estimates grouped in studies and in countries. Three bivariate models were developed: a cross-classified model to accommodate data from multinational studies, a hierarchical model with multinational data allocated to a single category at country level, and a hierarchical model excluding multinational data. Covariates at different levels were drawn from a long list of factors suggested in the literature. Results. We found 67 studies reporting 2094 cost-effectiveness estimates relating to 23 countries (6 studies reporting for more than 1 country). Data and study-level covariates included patient characteristics, intervention and comparator cost, and some study methods (e.g., discount rates and time horizon). After adjusting for these factors, the proportion of variation attributable to countries was negligible in the cross-classified model but moderate in the hierarchical models (14%−19% of total variance). Country-level variables that improved the fit of the hierarchical models included measures of income and health care finance, health care resources, and population risks. Conclusions. Our analysis suggested that variability in published cost-effectiveness estimates is related more to differences in study methods than to differences in national context. Multinational studies were associated with much lower country-level variation than single-country studies. These findings are for a single clinical question and may be atypical. PMID:25878194

Probability of Finding Marrow Unrelated Donor (MUD) for an Indian patient in a Multi-national Human Leukocyte Antigen (HLA) Registry.

PubMed

Tiwari, Aseem K; Bhati-Kushwaha, Himakshi; Kukreja, Pooja; Mishra, Vikash C; Tyagi, Neetu; Sharma, Ashish; Raina, Vimarsh

2015-06-01

With an increase in the number of transplants happening globally, hematopoietic stem cells (HSC) transplantation from matched unrelated donor (MUD) has begun. The increasing trend of MUD transplants across countries has been largely facilitated with the conspicuous growth of volunteer HSC donor noted in the last decade i.e. 8 million HSC donors in 2002 to more than 22 million in 2013 registered in 71 member registries of the Bone Marrow Donor Worldwide (BMDW). Some populations of the world are still very poorly represented in these registries. Since, the chances of successful engraftment and disease free survival are directly proportional to the HLA compatibility between the recipient and the prospective donor, the diversity of the HLA system at the antigenic and allelic level and the heterogeneity of HLA data of the registered donors has a bearing on the probability of finding a volunteer unrelated HSC donor for patients from such populations. In the present study 126 patients were identified suffering from hematological diseases requiring MUD transplant. Their HLA typing was performed and search was done using BMDW database. The search results for these Indian patients in the multinational registry as well as in the Indian Registries were analyzed using mean, range, standard deviation and finally evaluated in terms of probability for finding matched donor (MUD). Total Asian population is only 11 % in the BMDW making it difficult to find a MUD for an Asian patient. The current study supports this, experimentally; revealing that the probability of finding an allele match for an Indian patient in the multinational Human Leukocyte Antigen (HLA) registries is 16 % and a dismal 0.008 % in the Indian registries (donors in Indian registries is just 33,678 as compared to 22.5 million in BMDW). This greatly, emphasizes on enhancing the number of Indian donors in Indian and multi-national registries.

Unsafe sexual behaviour in domestic and foreign migrant male workers in multinational workplaces in Jordan: occupational-based and behavioural assessment survey

PubMed Central

Al Rifai, Rami; Nakamura, Keiko; Seino, Kaoruko; Kizuki, Masashi; Morita, Ayako

2015-01-01

Objectives To examine the prevalence of unsafe sexual behaviour, sexually transmitted infection (STI)-related knowledge, health and work-related conditions, and correlates of practising unsafe sex among domestic and foreign male workers in multinational workplaces in Jordan. Design Cross-sectional behavioural assessment survey. Setting Multinational workplaces in Jordan. Participants 230 Jordanian and 480 foreign male workers aged ≥18 years who had worked in a Qualified Industrial Zone (QIZ) for 12 months or more. Outcomes The primary outcome was the prevalence of practising unsafe sex. ‘Unsafe sex’ was defined as sex with a non-regular sexual partner with inconsistent condom usage. Results Overall, 74.3% of workers reported lifetime sexual experience. The proportion of lifetime unsafe sex was similar among domestic (31.8%) and foreign (35.6%) workers. Of those, 59.2% of domestic and 68.1% of foreign workers started practising unsafe sex after joining the QIZ. Rates of lifetime unsafe sex were significantly higher among those who had their sexual debut after joining the QIZ in domestic (aOR, 2.2, 95% CI 1.1 to 4.4) and foreign workers (aOR, 2.4, 95% CI 1.4 to 4.1). Among the domestic workers, being 18–24 years old (aOR, 4.9), unmarried (aOR, 4.8), working in the QIZ for 5–8 years (aOR, 5.0), sometimes/frequently shopped with foreign workers (aOR, 2.1) or were current/ex-alcohol drinkers (aORs, 3.4) were independently significantly associated with higher odds of practising unsafe sex. Conclusions A significant proportion of domestic and foreign male workers had been practising unsafe sex. The findings indicated that not only foreigners but also domestic male workers associating with foreign workers are at high risk of unsafe sex. Tailored interventions to promote safer sex in multinational workplaces in Jordan are needed. PMID:26068511

Insulin delivery and nocturnal glucose control in children and adolescents with type 1 diabetes.

PubMed

Tauschmann, Martin; Hovorka, Roman

2017-12-01

Nocturnal glucose control remains challenging in children and adolescents with type 1 diabetes due to highly variable overnight insulin requirements. The issue may be addressed by glucose responsive insulin delivery based on real-time continuous glucose measurements. Areas covered: This review outlines recent developments of glucose responsive insulin delivery systems from a paediatric perspective. We cover threshold-based suspend application, predictive low glucose suspend, and more advanced single hormone and dual-hormone closed-loop systems. Approaches are evaluated in relation to nocturnal glucose control particularly during outpatient randomised controlled trials. Expert opinion: Significant progress translating research from controlled clinical centre settings to free-living unsupervised home studies have been achieved over the past decade. Nocturnal glycaemic control can be improved whilst reducing the risk of hypoglycaemia with closed-loop systems. Following the US regulatory approval of the first hybrid closed-loop system in non-paediatric population, large multinational closed-loop clinical trials and pivotal studies including paediatric populations are underway or in preparation to facilitate the use of closed-loop systems in clinical practice.

ASTER, a multinational Earth observing concept

NASA Technical Reports Server (NTRS)

Bothwell, Graham W.; Geller, Gary N.; Larson, Steven A.; Morrison, Andrew D.; Nichols, David A.

1993-01-01

The Advanced Spaceborne Thermal Emission and Reflection Radiometer (ASTER) is a facility instrument selected for launch in 1998 on the first in a series of spacecraft for NASA's Earth Observing System (EOS). The ASTER instrument is being sponsored and built in Japan. It is a three telescope, high spatial resolution imaging instrument with 15 spectral bands covering the visible through to the thermal infrared. It will play a significant role within EOS providing geological, biological, land hydrological information necessary for intense study of the Earth. The operational capabilities for ASTER, including the necessary interfaces and operational collaborations between the US and Japanese participants, are under development. EOS operations are the responsibility of the EOS Project at NASA's Goddard Space Flight Center (GSFC). Although the primary EOS control center is at GSFC, the ASTER control facility will be in Japan. Other aspects of ASTER are discussed.

Multinational Alcohol Market Development and Public Health: Diageo in India

PubMed Central

Jernigan, David H.

2015-01-01

Alcohol is a risk factor for communicable and noncommunicable diseases, and alcohol consumption is rising steadily in India. The growth of multinational alcohol corporations, such as Diageo, contributes to India’s changing alcohol environment. We provide a brief history of India’s alcohol regulation for context and examine Diageo’s strategies for expansion in India in 2013 and 2014. Diageo is attracted to India’s younger generation, women, and emerging middle class for growth opportunities. Components of Diageo’s responsibility strategy conflict with evidence-based public health recommendations for reducing harmful alcohol consumption. Diageo’s strategies for achieving market dominance in India are at odds with public health evidence. We conclude with recommendations for protecting public health in emerging markets. PMID:26378848

Taxation of income of multinational corporations: the case of the United States petroleum industry

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

Jenkins, G.P.; Wright, B.D.

1975-02-01

While U.S. petroleum corporations pay no U.S. tax on foreign income, they received in the 1969-1972 period a rate of return on foreign investment comparable to domestic corporate investments. The present U.S. tax system allows tax credits from one foreign country to offset U.S. taxes from foreign income, with the result that the U.S. receives virtually no corporate income tax from foreign petroleum investments. The multinational corporations use transfer pricing to shift profits between countries so that tax liabilities will be minimized. Loss of revenue to consumer countries due to transfer pricing is estimated at $205 million in 1966 andmore » $240 million in 1970. (19 references) (DCK)« less

Global asbestos justice: South African asbestos victims win right to sue Cape PLC in U.K. courts.

PubMed

Kazan-Allen, L

2001-01-01

A ruling by Britain's House of Lords in July 2000 opened the doors of the English courts to foreign plaintiffs injured by the overseas operation of British companies and their subsidiaries. The ruling authorized 3,000 South African asbestos victims to continue their case in the U.K. courts against the multinational British company Cape PLC, which produced both raw asbestos and asbestos products in South Africa. The Lords sided with the asbestos victims in refusing to transfer the case to South Africa, as requested by Cape. This decision was a reversal of fortune for Cape and has implications for other British multinationals that may be called upon to defend their overseas actions domestically.

Involving Communities in Deciding What Benefits They Receive in Multinational Research

PubMed Central

Wendler, David; Shah, Seema

2015-01-01

There is wide agreement that communities in lower-income countries should benefit when they participate in multinational research. Debate now focuses on how and to what extent these communities should benefit. This debate has identified compelling reasons to reject the claim that whatever benefits a community agrees to accept are necessarily fair. Yet, those who conduct clinical research may conclude from this rejection that there is no reason to involve communities in the process of deciding how they benefit. Against this possibility, the present manuscript argues that involving host communities in this process helps to promote four important goals: (1) protecting host communities, (2) respecting host communities, (3) promoting transparency, and (4) enhancing social value. PMID:26224724

A multinational report of technical factors on stereotactic body radiotherapy for oligometastases.

PubMed

Redmond, Kristin J; Lo, Simon S; Dagan, Roi; Poon, Ian; Foote, Matthew C; Erler, Darby; Lee, Young; Lohr, Frank; Biswas, Tithi; Ricardi, Umberto; Sahgal, Arjun

2017-05-01

Oligometastatic cancer is being increasingly managed with aggressive local therapy using stereotactic body radiation therapy (SBRT). However, few guidelines exist. We summarize the results of an international survey reviewing technical factors for extracranial SBRT for oligometastatic disease to guide safe management. Seven high-volume centers contributed. Levels of agreement were categorized as strong (6-7 common responses), moderate (4-5), low (2-3) or no agreement. We present the results of a multi-national and multi-institutional survey of technical factors of SBRT for extracranial oligometastases. Key methods including target delineation, prescription doses, normal tissue constraints, imaging and set-up for safe implementation and practice of SBRT for oligometastasis have been identified. This manuscript will serve as a foundation for future clinical evaluations.

Evaluating the importance of policy amenable factors in explaining influenza vaccination: a cross-sectional multinational study

PubMed Central

Wheelock, Ana; Miraldo, Marisa; Thomson, Angus; Vincent, Charles; Sevdalis, Nick

2017-01-01

Objectives Despite continuous efforts to improve influenza vaccination coverage, uptake among high-risk groups remains suboptimal. We aimed to identify policy amenable factors associated with vaccination and to measure their importance in order to assist in the monitoring of vaccination sentiment and the design of communication strategies and interventions to improve vaccination rates. Setting The USA, the UK and France. Participants A total of 2412 participants were surveyed across the three countries. Outcome measures Self-reported influenza vaccination. Methods Between March and April 2014, a stratified random sampling strategy was employed with the aim of obtaining nationally representative samples in the USA, the UK and France through online databases and random-digit dialling. Participants were asked about vaccination practices, perceptions and feelings. Multivariable logistic regression was used to identify factors associated with past influenza vaccination. Results The models were able to explain 64%–80% of the variance in vaccination behaviour. Overall, sociopsychological variables, which are inherently amenable to policy, were better at explaining past vaccination behaviour than demographic, socioeconomic and health variables. Explanatory variables included social influence (physician), influenza and vaccine risk perceptions and traumatic childhood experiences. Conclusions Our results indicate that evidence-based sociopsychological items should be considered for inclusion into national immunisation surveys to gauge the public’s views, identify emerging concerns and thus proactively and opportunely address potential barriers and harness vaccination drivers. PMID:28706088

The use of abstract paintings and narratives to foster reflective capacity in medical educators: a multinational faculty development workshop

PubMed Central

Karkabi, Khaled; Wald, Hedy S; Cohen Castel, Orit

2014-01-01

Reflective capacity is integral to core healthcare professional practice competencies. Reflection plays a central role in teacher education as reflecting on teaching behaviours with critical analysis can potentially improve teaching practice. The humanities including narrative and the visual arts can serve as a valuable tool for fostering reflection. We conducted a multinational faculty development workshop aiming to enhance reflective capacity in medical educators by using a combination of abstract paintings and narratives. Twenty-three family physicians or physicians-in-training from 10 countries participated in the workshop. Qualitative assessment of the workshop showed that the combined use of art and narrative was well received and perceived as contributing to the reflective exercise. Participants generally felt that viewing abstract paintings had facilitated a valuable mood transformation and prepared them emotionally for the reflective writing. Our analysis found that the following themes emerged from participants’ responses: (1) narratives from different countries are similar; (2) the use of art helped access feelings; (3) viewing abstract paintings facilitated next steps; (4) writing reflective narratives promoted examination of educational challenges, compassion for self and other, and building an action plan; and (5) sharing of narrative was helpful for fostering active listening and appreciating multiple perspectives. Future research might include comparing outcomes for a group participating in arts–narrative-based workshops with those of a control group using only reflective narrative or in combination with figurative art, and implementing a combination of qualitative and quantitative methods of assessment. PMID:24273319

Safety and efficacy of turoctocog alfa (NovoEight®) during surgery in patients with haemophilia A: results from the multinational guardian™ clinical trials

PubMed Central

Santagostino, E; Lentz, S R; Misgav, M; Brand, B; Chowdary, P; Savic, A; Kilinc, Y; Amit, Y; Amendola, A; Solimeno, L P; Saugstrup, T; Matytsina, I

2015-01-01

Recombinant factor VIII (rFVIII) products provide a safe and efficacious replacement therapy for prevention and treatment of bleeding episodes in patients with haemophilia A. The present investigations from the multinational, open-label guardian™ clinical trials assessed the haemostatic response of turoctocog alfa (NovoEight®), a rFVIII product, in patients with severe haemophilia A (FVIII ≤ 1%) undergoing surgery. All patients had a minimum of 50 exposure days to any FVIII product prior to surgery and no history of inhibitors. A total of 41 procedures (13 orthopaedic, 19 dental and 9 general) were performed in 33 patients aged 4–59 years. Of the 41 procedures, 15 were major surgeries in 13 patients and 26 were minor surgeries in 21 patients. The success rate for haemostatic response was 100% (success was defined as ‘excellent’ or ‘good’ haemostatic outcome). Turoctocog alfa consumption on the day of surgery ranged from 27 to 153 IU kg−1. The mean daily dose declined over time, while retaining adequate FVIII coverage as measured by trough levels. Overall, no safety issues were identified. No thrombotic events were observed and none of the patients developed FVIII inhibitors. In conclusion, the present results show that turoctocog alfa was effective in controlling blood loss by obtaining a sufficient haemostatic response in patients with severe haemophilia A undergoing surgery. PMID:25273984

Safety and efficacy of turoctocog alfa (NovoEight®) during surgery in patients with haemophilia A: results from the multinational guardian™ clinical trials.

PubMed

Santagostino, E; Lentz, S R; Misgav, M; Brand, B; Chowdary, P; Savic, A; Kilinc, Y; Amit, Y; Amendola, A; Solimeno, L P; Saugstrup, T; Matytsina, I

2015-01-01

Recombinant factor VIII (rFVIII) products provide a safe and efficacious replacement therapy for prevention and treatment of bleeding episodes in patients with haemophilia A. The present investigations from the multinational, open-label guardian(™) clinical trials assessed the haemostatic response of turoctocog alfa (NovoEight(®)), a rFVIII product, in patients with severe haemophilia A (FVIII ≤ 1%) undergoing surgery. All patients had a minimum of 50 exposure days to any FVIII product prior to surgery and no history of inhibitors. A total of 41 procedures (13 orthopaedic, 19 dental and 9 general) were performed in 33 patients aged 4-59 years. Of the 41 procedures, 15 were major surgeries in 13 patients and 26 were minor surgeries in 21 patients. The success rate for haemostatic response was 100% (success was defined as 'excellent' or 'good' haemostatic outcome). Turoctocog alfa consumption on the day of surgery ranged from 27 to 153 IU kg(-1). The mean daily dose declined over time, while retaining adequate FVIII coverage as measured by trough levels. Overall, no safety issues were identified. No thrombotic events were observed and none of the patients developed FVIII inhibitors. In conclusion, the present results show that turoctocog alfa was effective in controlling blood loss by obtaining a sufficient haemostatic response in patients with severe haemophilia A undergoing surgery. © 2014 The Authors. Haemophilia Published by John Wiley & Sons Ltd.

Effect of darapladib on major coronary events after an acute coronary syndrome: the SOLID-TIMI 52 randomized clinical trial.

PubMed

O'Donoghue, Michelle L; Braunwald, Eugene; White, Harvey D; Steen, Dylan P; Lukas, Mary Ann; Tarka, Elizabeth; Steg, P Gabriel; Hochman, Judith S; Bode, Christoph; Maggioni, Aldo P; Im, KyungAh; Shannon, Jennifer B; Davies, Richard Y; Murphy, Sabina A; Crugnale, Sharon E; Wiviott, Stephen D; Bonaca, Marc P; Watson, David F; Weaver, W Douglas; Serruys, Patrick W; Cannon, Christopher P; Steen, Dylan L

2014-09-10

Lipoprotein-associated phospholipase A2 (Lp-PLA2) has been hypothesized to be involved in atherogenesis through pathways related to inflammation. Darapladib is an oral, selective inhibitor of the Lp-PLA2 enzyme. To evaluate the efficacy and safety of darapladib in patients after an acute coronary syndrome (ACS) event. SOLID-TIMI 52 was a multinational, double-blind, placebo-controlled trial that randomized 13,026 participants within 30 days of hospitalization with an ACS (non-ST-elevation or ST-elevation myocardial infarction [MI]) at 868 sites in 36 countries. Patients were randomized to either once-daily darapladib (160 mg) or placebo on a background of guideline-recommended therapy. Patients were followed up for a median of 2.5 years between December 7, 2009, and December 6, 2013. The primary end point (major coronary events) was the composite of coronary heart disease (CHD) death, MI, or urgent coronary revascularization for myocardial ischemia. Kaplan-Meier event rates are reported at 3 years. During a median duration of 2.5 years, the primary end point occurred in 903 patients in the darapladib group and 910 in the placebo group (16.3% vs 15.6% at 3 years; hazard ratio [HR], 1.00 [95% CI, 0.91-1.09]; P = .93). The composite of cardiovascular death, MI, or stroke occurred in 824 in the darapladib group and 838 in the placebo group (15.0% vs 15.0% at 3 years; HR, 0.99 [95% CI, 0.90-1.09]; P = .78). There were no differences between the treatment groups for additional secondary end points, for individual components of the primary end point, or in all-cause mortality (371 events in the darapladib group and 395 in the placebo group [7.3% vs 7.1% at 3 years; HR, 0.94 [95% CI, 0.82-1.08]; P = .40). Patients were more likely to report an odor-related concern in the darapladib group vs the placebo group (11.5% vs 2.5%) and also more likely to report diarrhea (10.6% vs 5.6%). In patients who experienced an ACS event, direct inhibition of Lp-PLA2 with darapladib added to optimal medical therapy and initiated within 30 days of hospitalization did not reduce the risk of major coronary events. clinicaltrials.gov Identifier: NCT01000727.

The use of group sequential, information-based sample size re-estimation in the design of the PRIMO study of chronic kidney disease.

PubMed

Pritchett, Yili; Jemiai, Yannis; Chang, Yuchiao; Bhan, Ishir; Agarwal, Rajiv; Zoccali, Carmine; Wanner, Christoph; Lloyd-Jones, Donald; Cannata-Andía, Jorge B; Thompson, Taylor; Appelbaum, Evan; Audhya, Paul; Andress, Dennis; Zhang, Wuyan; Solomon, Scott; Manning, Warren J; Thadhani, Ravi

2011-04-01

Chronic kidney disease is associated with a marked increase in risk for left ventricular hypertrophy and cardiovascular mortality compared with the general population. Therapy with vitamin D receptor activators has been linked with reduced mortality in chronic kidney disease and an improvement in left ventricular hypertrophy in animal studies. PRIMO (Paricalcitol capsules benefits in Renal failure Induced cardia MOrbidity) is a multinational, multicenter randomized controlled trial to assess the effects of paricalcitol (a selective vitamin D receptor activator) on mild to moderate left ventricular hypertrophy in patients with chronic kidney disease. Subjects with mild-moderate chronic kidney disease are randomized to paricalcitol or placebo after confirming left ventricular hypertrophy using a cardiac echocardiogram. Cardiac magnetic resonance imaging is then used to assess left ventricular mass index at baseline, 24 and 48 weeks, which is the primary efficacy endpoint of the study. Because of limited prior data to estimate sample size, a maximum information group sequential design with sample size re-estimation is implemented to allow sample size adjustment based on the nuisance parameter estimated using the interim data. An interim efficacy analysis is planned at a pre-specified time point conditioned on the status of enrollment. The decision to increase sample size depends on the observed treatment effect. A repeated measures analysis model, using available data at Week 24 and 48 with a backup model of an ANCOVA analyzing change from baseline to the final nonmissing observation, are pre-specified to evaluate the treatment effect. Gamma-family of spending function is employed to control family-wise Type I error rate as stopping for success is planned in the interim efficacy analysis. If enrollment is slower than anticipated, the smaller sample size used in the interim efficacy analysis and the greater percent of missing week 48 data might decrease the parameter estimation accuracy, either for the nuisance parameter or for the treatment effect, which might in turn affect the interim decision-making. The application of combining a group sequential design with a sample-size re-estimation in clinical trial design has the potential to improve efficiency and to increase the probability of trial success while ensuring integrity of the study.

Organizatonal Communication Issues in Italian Multinational Corporations.

ERIC Educational Resources Information Center

Cesaria, Ruggero

2000-01-01

Provides a brief historical reconstruction of management communication in Italian companies. Suggests that dealing with communication technologies, communication professionals, and intercultural communication represent three future challenges. (NH)

Cost-effectiveness of a complex workplace dietary intervention: an economic evaluation of the Food Choice at Work study

PubMed Central

Fitzgerald, Sarah; Murphy, Aileen; Kirby, Ann; Geaney, Fiona; Perry, Ivan J

2018-01-01

Objective To evaluate the costs, benefits and cost-effectiveness of complex workplace dietary interventions, involving nutrition education and system-level dietary modification, from the perspective of healthcare providers and employers. Design Single-study economic evaluation of a cluster-controlled trial (Food Choice at Work (FCW) study) with 1-year follow-up. Setting Four multinational manufacturing workplaces in Cork, Ireland. Participants 517 randomly selected employees (18–65 years) from four workplaces. Interventions Cost data were obtained from the FCW study. Nutrition education included individual nutrition consultations, nutrition information (traffic light menu labelling, posters, leaflets and emails) and presentations. System-level dietary modification included menu modification (restriction of fat, sugar and salt), increase in fibre, fruit discounts, strategic positioning of healthier alternatives and portion size control. The combined intervention included nutrition education and system-level dietary modification. No intervention was implemented in the control. Outcomes The primary outcome was an improvement in health-related quality of life, measured using the EuroQoL 5 Dimensions 5 Levels questionnaire. The secondary outcome measure was reduction in absenteeism, which is measured in monetary amounts. Probabilistic sensitivity analysis (Monte Carlo simulation) assessed parameter uncertainty. Results The system-level intervention dominated the education and combined interventions. When compared with the control, the incremental cost-effectiveness ratio (€101.37/quality-adjusted life-year) is less than the nationally accepted ceiling ratio, so the system-level intervention can be considered cost-effective. The cost-effectiveness acceptability curve indicates there is some decision uncertainty surrounding this, arising from uncertainty surrounding the differences in effectiveness. These results are reiterated when the secondary outcome measure is considered in a cost–benefit analysis, whereby the system-level intervention yields the highest net benefit (€56.56 per employee). Conclusions System-level dietary modification alone offers the most value per improving employee health-related quality of life and generating net benefit for employers by reducing absenteeism. While system-level dietary modification strategies are potentially sustainable obesity prevention interventions, future research should include long-term outcomes to determine if improvements in outcomes persist. Trial registration number ISRCTN35108237; Post-results. PMID:29502090

REVIEWING HIV-RELATED RESEARCH IN EMERGING ECONOMIES: THE ROLE OF GOVERNMENT REVIEWING AGENCIES

PubMed Central

Klitzman, Robert; Sexton, Patrina; Hui, Katrina; Hanrahan, Donna; Barnes, Mark; Sugarman, Jeremy; London, Alex John

2015-01-01

Little research has explored the possible effects of government institutions in emerging economies on ethical reviews of multinational research. We conducted semi-structured, in-depth telephone interviews with 15 researchers, Research Ethics Committees (RECs) personnel, and a government agency member involved in multinational HIV Prevention Trials Network (HPTN) research in emerging economies. Ministries of Health (MOH) or other government agencies often play pivotal roles as facilitators or barriers in the research ethics approval process. Government agency RECs reviewing protocols may face particular challenges, as they can lack resources, be poorly organized, have inconsistent review processes and, limited expertise, use differing definitions of national interests, including upholding national reputation and avoiding potential exploitation and stigma of the country’s population. The MOH/governmental review body may be affected by power dynamics and politics in study reviews; may consider issues both related and unrelated to research ethics as understood elsewhere; and may prioritize particular diseases, treatments, or interventions over other topics/types of research. Poor communication and deeply-rooted tensions may exist between sponsor and host countries, impeding optimal interactions and reviews. Investigators must understand and plan for the potential effects of governmental agencies on multinational collaborative research, including preserving adequate time for agency review, and contacting these agencies beforehand to address issues that may arise. Better understanding of these issues can aid and advance appropriate global scientific collaboration. PMID:25388003

Pirfenidone for idiopathic pulmonary fibrosis: analysis of pooled data from three multinational phase 3 trials.

PubMed

Noble, Paul W; Albera, Carlo; Bradford, Williamson Z; Costabel, Ulrich; du Bois, Roland M; Fagan, Elizabeth A; Fishman, Robert S; Glaspole, Ian; Glassberg, Marilyn K; Lancaster, Lisa; Lederer, David J; Leff, Jonathan A; Nathan, Steven D; Pereira, Carlos A; Swigris, Jeffrey J; Valeyre, Dominique; King, Talmadge E

2016-01-01

Pirfenidone is an antifibrotic agent that has been evaluated in three multinational phase 3 trials in patients with idiopathic pulmonary fibrosis (IPF). We analysed pooled data from the multinational trials to obtain the most precise estimates of the magnitude of treatment effect on measures of disease progression.All patients randomised to pirfenidone 2403 mg·day(-1) or placebo in the CAPACITY or ASCEND studies were included in the analysis. Pooled analyses of outcomes at 1 year were based on the pre-specified end-points and analytic methods described in the ASCEND study protocol.A total of 1247 patients were included in the analysis. At 1 year, pirfenidone reduced the proportion of patients with a ≥10% decline in per cent predicted forced vital capacity or death by 43.8% (95% CI 29.3-55.4%) and increased the proportion of patients with no decline by 59.3% (95% CI 29.0-96.8%). A treatment benefit was also observed for progression-free survival, 6-min walk distance and dyspnoea. Gastrointestinal and skin-related adverse events were more common in the pirfenidone group, but rarely led to discontinuation.Analysis of data from three phase 3 trials demonstrated that treatment with pirfenidone for 1 year resulted in clinically meaningful reductions in disease progression in patients with IPF. Copyright ©ERS 2016.

Reviewing HIV-Related Research in Emerging Economies: The Role of Government Reviewing Agencies.

PubMed

Sexton, Patrina; Hui, Katrina; Hanrahan, Donna; Barnes, Mark; Sugarman, Jeremy; London, Alex John; Klitzman, Robert

2016-04-01

Little research has explored the possible effects of government institutions in emerging economies on ethical reviews of multinational research. We conducted semi-structured, in-depth telephone interviews with 15 researchers, Research Ethics Committees (RECs) personnel, and a government agency member involved in multinational HIV Prevention Trials Network (HPTN) research in emerging economies. Ministries of Health (MOH) or other government agencies often play pivotal roles as facilitators or barriers in the research ethics approval process. Government agency RECs reviewing protocols may face particular challenges, as they can lack resources, be poorly organized, have inconsistent review processes and limited expertise, and use differing definitions of national interests, including upholding national reputation and avoiding potential exploitation and stigma of the country's population. The MOH/governmental review body may be affected by power dynamics and politics in study reviews; may consider issues both related and unrelated to research ethics as understood elsewhere; and may prioritize particular diseases, treatments, or interventions over other topics/types of research. Poor communication and deeply-rooted tensions may exist between sponsor and host countries, impeding optimal interactions and reviews. Investigators must understand and plan for the potential effects of governmental agencies on multinational collaborative research, including preserving adequate time for agency review, and contacting these agencies beforehand to address issues that may arise. Better understanding of these issues can aid and advance appropriate global scientific collaboration. © 2014 John Wiley & Sons Ltd.

Pirfenidone for idiopathic pulmonary fibrosis: analysis of pooled data from three multinational phase 3 trials

PubMed Central

Albera, Carlo; Bradford, Williamson Z.; Costabel, Ulrich; du Bois, Roland M.; Fagan, Elizabeth A.; Fishman, Robert S.; Glaspole, Ian; Glassberg, Marilyn K.; Lancaster, Lisa; Lederer, David J.; Leff, Jonathan A.; Nathan, Steven D.; Pereira, Carlos A.; Swigris, Jeffrey J.; Valeyre, Dominique; King, Talmadge E.

2016-01-01

Pirfenidone is an antifibrotic agent that has been evaluated in three multinational phase 3 trials in patients with idiopathic pulmonary fibrosis (IPF). We analysed pooled data from the multinational trials to obtain the most precise estimates of the magnitude of treatment effect on measures of disease progression. All patients randomised to pirfenidone 2403 mg·day−1 or placebo in the CAPACITY or ASCEND studies were included in the analysis. Pooled analyses of outcomes at 1 year were based on the pre-specified end-points and analytic methods described in the ASCEND study protocol. A total of 1247 patients were included in the analysis. At 1 year, pirfenidone reduced the proportion of patients with a ≥10% decline in per cent predicted forced vital capacity or death by 43.8% (95% CI 29.3–55.4%) and increased the proportion of patients with no decline by 59.3% (95% CI 29.0–96.8%). A treatment benefit was also observed for progression-free survival, 6-min walk distance and dyspnoea. Gastrointestinal and skin-related adverse events were more common in the pirfenidone group, but rarely led to discontinuation. Analysis of data from three phase 3 trials demonstrated that treatment with pirfenidone for 1 year resulted in clinically meaningful reductions in disease progression in patients with IPF. PMID:26647432

Tobacco smoking: the leading cause of preventable disease worldwide.

PubMed

Samet, Jonathan M

2013-05-01

Tobacco smoking is the world's leading cause of avoidable premature mortality, reflecting the potent toxicity of tobacco smoke inhaled by smokers for decades. In the twentieth century, lung cancer was an early sentinel of the emergence of the still persisting epidemic of tobacco-caused disease. Smoking has declined in many countries, particularly the high-income countries, but low- and middle-income countries remain at risk because of the aggressive tactics of tobacco multinationals. The World Health Organization treaty, the Framework Convention on Tobacco Control, is a critical factor in countering these tactics and precipitating the end of the global epidemic of tobacco smoking. Copyright © 2013 Elsevier Inc. All rights reserved.

Cooperative global security programs modeling & simulation.

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

Briand, Daniel

2010-05-01

The national laboratories global security programs implement sustainable technical solutions for cooperative nonproliferation, arms control, and physical security systems worldwide. To help in the development and execution of these programs, a wide range of analytical tools are used to model, for example, synthetic tactical environments for assessing infrastructure protection initiatives and tactics, systematic approaches for prioritizing nuclear and biological threat reduction opportunities worldwide, and nuclear fuel cycle enrichment and spent fuel management for nuclear power countries. This presentation will describe how these models are used in analyses to support the Obama Administration's agenda and bilateral/multinational treaties, and ultimately, to reducemore » weapons of mass destruction and terrorism threats through international technical cooperation.« less

Fertility conserving management of early cervical cancer: our experience of LLETZ and pelvic lymph node dissection.

PubMed

Lindsay, Rhona; Burton, Kevin; Shanbhag, Smruta; Tolhurst, Jenny; Millan, David; Siddiqui, Nadeem

2014-01-01

Presently, for those diagnosed with early cervical cancer who wish to conserve their fertility, there is the option of radical trachelectomy. Although successful, this procedure is associated with significant obstetric morbidity. The recurrence risk of early cervical cancer is low and in tumors measuring less than 2 cm; if the lymphatics are negative, the likelihood of parametrial involvement is less than 1%. Therefore, pelvic lymph nodes are a surrogate marker of parametrial involvement and radical excision of the parametrium can be omitted if they are negative. The aim of this study was to report our experience of the fertility conserving management of early cervical cancer with repeat large loop excision of the transformation zone and laparoscopic pelvic lymph node dissection. Between 2004 and 2011, a retrospective review of cases of early cervical cancer who had fertility conserving management within Glasgow Royal Infirmary was done. Forty-three patients underwent fertility conserving management of early cervical cancer. Forty were screen-detected cancers; 2 were stage IA1, 4 were stage IA2, and 37 were stage IB1. There were 2 central recurrences during the follow-up period. There have been 15 live children to 12 women and there are 4 ongoing pregnancies. To our knowledge, this is the largest case series described and confirms the low morbidity and mortality of this procedure. However, even within our highly select group, there have been 2 cases of central recurrent disease. We, therefore, are urging caution in the global adoption of this technique and would welcome a multicenter multinational randomized controlled trial.

The determinants of fat intake in a multi-ethnic New Zealand population. Fletcher Challenge--University of Auckland Heart and Health Study Management Committee.

PubMed

Swinburn, B A; Walter, L; Ricketts, H; Whitlock, G; Law, B; Norton, R; Jackson, R; MacMahon, S

1998-06-01

The New Zealand diet is high in total and saturated fat and this is likely to be contributing to the increasing prevalence of obesity and relatively high rates of coronary heart disease in New Zealand. The identification of subgroups with a high-fat intake will enable nutrition-related public health strategies to be better targeted. Subjects from two surveys were included in the study: 7574 employees from a large multinational workforce survey and 2447 people aged 35-84 years selected from a stratified random sample of the electoral roll in central Auckland. Fat and saturated fat intake were assessed by short questionnaire which gave a dietary fat habits (DFH) score and supplemented by a six-item food frequency questionnaire. The DFH scores were higher in males than in females at all ages, and there was an inverse relationship with age which was stronger for males. Age-adjusted scores showed significantly higher DFH scores for Maori than for Europeans. Lower socioeconomic status was associated with higher DFH scores in males. Current smoking and heavy drinking (in males) were associated with significantly higher DFH scores after controlling for socioeconomic status. The results of the limited food frequency questionnaire supported the trends in DFH scores. The subgroups with high total and saturated fat intakes which should be a priority for public health action are young and middle-aged males, Maori and lower socioeconomic status males. The clustering of high-fat intake with smoking and heavy drinking should be considered when developing preventative strategies.

Design and Analysis of Cognitive Interviews for Comparative Multinational Testing

PubMed Central

Fitzgerald, Rory; Padilla, José-Luis; Willson, Stephanie; Widdop, Sally; Caspar, Rachel; Dimov, Martin; Gray, Michelle; Nunes, Cátia; Prüfer, Peter; Schöbi, Nicole; Schoua-Glusberg, Alisú

2011-01-01

This article summarizes the work of the Comparative Cognitive Testing Workgroup, an international coalition of survey methodologists interested in developing an evidence-based methodology for examining the comparability of survey questions within cross-cultural or multinational contexts. To meet this objective, it was necessary to ensure that the cognitive interviewing (CI) method itself did not introduce method bias. Therefore, the workgroup first identified specific characteristics inherent in CI methodology that could undermine the comparability of CI evidence. The group then developed and implemented a protocol addressing those issues. In total, 135 cognitive interviews were conducted by participating countries. Through the process, the group identified various interpretive patterns resulting from sociocultural and language-related differences among countries as well as other patterns of error that would impede comparability of survey data. PMID:29081719

Involving Communities in Deciding What Benefits They Receive in Multinational Research.

PubMed

Wendler, David; Shah, Seema

2015-10-01

There is wide agreement that communities in lower-income countries should benefit when they participate in multinational research. Debate now focuses on how and to what extent these communities should benefit. This debate has identified compelling reasons to reject the claim that whatever benefits a community agrees to accept are necessarily fair. Yet, those who conduct clinical research may conclude from this rejection that there is no reason to involve communities in the process of deciding how they benefit. Against this possibility, the present manuscript argues that involving host communities in this process helps to promote four important goals: (1) protecting host communities, (2) respecting host communities, (3) promoting transparency, and (4) enhancing social value. Published by Oxford University Press on behalf of the Journal of Medicine and Philosophy, Inc. 2015.

Exposure of US multinational corporations to foreign exchange fluctuations arising from the translation of the financial statements of their offshore subsidiaries

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

Doukas, P.G.

1984-01-01

This study examines the nature of balance-sheet exposures (as opposed to transaction and economic exposures), arising from the translation of financial statements from one currency to another. A survey of 130 multinationals concludes that corporations viewed as economic what could actually affect their reported earnings and consequently stock prices in a material way. As a result, about 60% of the companies surveyed apparently hedged some part of their balance-sheet exposures under FAS-8. However, only four companies hedge under the new translation rules prescribed by FAS-52, which allows translation gains and losses to be posted directly to equity. A test ofmore » stock-price reaction to the disclo« less

[Health impact assessment of occupational health policy reform at a multinational chemical company in Japan].

PubMed

Fujino, Yoshihisa; Nagata, Tomohisa; Kuroki, Naomi; Dohi, Seitaro; Uehara, Masamichi; Oyama, Ichiro; Kajiki, Shigeyuki; Mori, Koji

2009-09-01

A health impact assessment (HIA) was conducted to identify potential health impacts arising from policy reform of occupational health and safety at S-chemical company, a multinational global company that employs about 13,000 workers. A multidisciplinary team of health professionals including occupational physicians, an epidemiologist, and public health researchers oversaw the HIA. A project manager from S-company was also involved in the whole HIA process. A literature review, profiling using annual health examination data and interviews with stakeholders and key informants were undertaken in order to identify possible impacts. A range of positive and negative health impacts were identified and develop recommendations for implementation of the new occupational health policy were proposed. The HIA added value to the planning process for the occupational health policy reform.

Design and rationale for the Effects of Ticagrelor and Clopidogrel in Patients with Peripheral Artery Disease (EUCLID) trial.

PubMed

Berger, Jeffrey S; Katona, Brian G; Jones, W Schuyler; Patel, Manesh R; Norgren, Lars; Baumgartner, Iris; Blomster, Juuso; Mahaffey, Kenneth W; Held, Peter; Millegård, Marcus; Heizer, Gretchen; Reist, Craig; Fowkes, F Gerry; Hiatt, William R

2016-05-01

Despite overwhelming data demonstrating the efficacy of antiplatelet therapy in heart disease and stroke, data in peripheral artery disease (PAD) are less compelling. Aspirin has modest evidence supporting a reduction in cardiovascular events in patients with PAD, whereas clopidogrel monotherapy may be more effective in PAD. Ticagrelor, a potent, reversibly binding P2Y12 receptor antagonist, is beneficial in patients with acute coronary syndrome and prior myocardial infarction. The EUCLID trial is designed to address the need for effective antiplatelet therapy in PAD to decrease the risk of cardiovascular events. EUCLID is a randomized, double-blind, parallel-group, multinational clinical trial designed to evaluate the efficacy and safety of ticagrelor compared with clopidogrel for the prevention of major adverse cardiovascular events in subjects with symptomatic PAD. Subjects with established PAD will be randomized in a 1:1 fashion to ticagrelor 90 mg twice daily or clopidogrel 75 mg daily. The primary end point is a composite of cardiovascular death, myocardial infarction, or ischemic stroke. Other end points address limb events including acute leg ischemia, need for revascularization, disease progression by ankle-brachial index, and quality of life. The primary safety objective is Thrombolysis in Myocardial Infarction-defined major bleeding. Recruitment began in December 2012 and was completed in March 2014; 13,887 patients were randomized. The trial will continue until at least 1,364 adjudicated primary end points occur. The EUCLID study is investigating whether treatment with ticagrelor versus clopidogrel, given as antiplatelet monotherapy, will reduce the incidence of cardiovascular and limb-specific events in patients with symptomatic PAD. Copyright © 2016 The Authors. Published by Elsevier Inc. All rights reserved.

Vitamin A and D Deficiencies Associated With Incident Tuberculosis in HIV-Infected Patients Initiating Antiretroviral Therapy in Multinational Case-Cohort Study.

PubMed

Tenforde, Mark W; Yadav, Ashish; Dowdy, David W; Gupte, Nikhil; Shivakoti, Rupak; Yang, Wei-Teng; Mwelase, Noluthando; Kanyama, Cecilia; Pillay, Sandy; Samaneka, Wadzanai; Santos, Breno; Poongulali, Selvamuthu; Tripathy, Srikanth; Riviere, Cynthia; Berendes, Sima; Lama, Javier R; Cardoso, Sandra W; Sugandhavesa, Patcharaphan; Christian, Parul; Semba, Richard D; Campbell, Thomas B; Gupta, Amita

2017-07-01

Numerous micronutrients have immunomodulatory roles that may influence risk of tuberculosis (TB), but the association between baseline micronutrient deficiencies and incident TB after antiretroviral therapy (ART) initiation in HIV-infected individuals is not well characterized. We conducted a case-cohort study (n = 332) within a randomized trial comparing 3 ART regimens in 1571 HIV treatment-naive adults from 9 countries. A subcohort of 30 patients was randomly selected from each country (n = 270). Cases (n = 77; main cohort = 62, random subcohort = 15) included patients diagnosed with TB by 96 weeks post-ART initiation. We determined pretreatment concentrations of vitamin A, carotenoids, vitamin B6, vitamin B12, vitamin D, vitamin E, and selenium. We measured associations between pretreatment micronutrient deficiencies and incident TB using Breslow-weighted Cox regression models. Median pretreatment CD4 T-cell count was 170 cells/mm; 47.3% were women; and 53.6% Black. In multivariable models after adjusting for age, sex, country, treatment arm, previous TB, baseline CD4 count, HIV viral load, body mass index, and C-reactive protein, pretreatment deficiency in vitamin A (adjusted hazard ratio, aHR 5.33, 95% confidence interval, CI: 1.54 to 18.43) and vitamin D (aHR 3.66, 95% CI: 1.16 to 11.51) were associated with TB post-ART. In a diverse cohort of HIV-infected adults from predominantly low- and middle-income countries, deficiencies in vitamin A and vitamin D at ART initiation were independently associated with increased risk of incident TB in the ensuing 96 weeks. Vitamin A and D may be important modifiable risk factors for TB in high-risk HIV-infected patients starting ART in resource-limited highly-TB-endemic settings.

Semuloparin for prevention of venous thromboembolism after major orthopedic surgery: results from three randomized clinical trials, SAVE-HIP1, SAVE-HIP2 and SAVE-KNEE.

PubMed

Lassen, M R; Fisher, W; Mouret, P; Agnelli, G; George, D; Kakkar, A; Mismetti, P; Turpie, A G G

2012-05-01

Semuloparin is a novel ultra-low-molecular-weight heparin under development for venous thromboembolism (VTE) prevention in patients at increased risk, such as surgical and cancer patients. Three Phase III studies compared semuloparin and enoxaparin after major orthopedic surgery: elective knee replacement (SAVE-KNEE), elective hip replacement (SAVE-HIP1) and hip fracture surgery (SAVE-HIP2). All studies were multinational, randomized and double-blind. Semuloparin and enoxaparin were administered for 7-10 days after surgery. Mandatory bilateral venography was to be performed between days 7 and 11. The primary efficacy endpoint was a composite of any deep vein thrombosis, non-fatal pulmonary embolism or all-cause death. Safety outcomes included major bleeding, clinically relevant non-major (CRNM) bleeding, and any clinically relevant bleeding (major bleeding plus CRNM). In total, 1150, 2326 and 1003 patients were randomized in SAVE-KNEE, SAVE-HIP1 and SAVE-HIP2, respectively. In all studies, the incidences of the primary efficacy endpoint were numerically lower in the semuloparin group vs. the enoxaparin group, but the difference was statistically significant only in SAVE-HIP1. In SAVE-HIP1, clinically relevant bleeding and major bleeding were significantly lower in the semuloparin vs. the enoxaparin group. In SAVE-KNEE and SAVE-HIP2, clinically relevant bleeding tended to be higher in the semuloparin group, but rates of major bleeding were similar in the two groups. Other safety parameters were generally similar between treatment groups. Semuloparin was superior to enoxaparin for VTE prevention after hip replacement surgery, but failed to demonstrate superiority after knee replacement surgery and hip fracture surgery. Semuloparin and enoxaparin exhibited generally similar safety profiles. © 2012 International Society on Thrombosis and Haemostasis.

Privatization and the Globalization of Energy Markets

EIA Publications

1996-01-01

Discusses recent efforts at privatization in petroleum, electricity, and coal, as well as the impetus that privatization has provided in fostering the evolution of the multinational and multidimensional energy company.

Dexmedetomidine: a review of its use for sedation in mechanically ventilated patients in an intensive care setting and for procedural sedation.

PubMed

Hoy, Sheridan M; Keating, Gillian M

2011-07-30

Dexmedetomidine (Precedex®), a pharmacologically active dextroisomer of medetomidine, is a selective α(2)-adrenergic receptor agonist. It is indicated in the US for the sedation of mechanically ventilated adult patients in an intensive care setting and in non-intubated adult patients prior to and/or during surgical and other procedures. This article reviews the pharmacological properties, therapeutic efficacy and tolerability of dexmedetomidine in randomized, double-blind, placebo-controlled, multicentre studies in these indications. Post-surgical patients in an intensive care setting receiving dexmedetomidine required less rescue sedation with intravenous propofol or intravenous midazolam to achieve and/or maintain optimal sedation during the assisted ventilation period than placebo recipients, according to two randomized, double-blind, multinational studies. Moreover, significantly more dexmedetomidine than placebo recipients acquired and/or maintained optimal sedation without rescue sedation. Sedation with dexmedetomidine was also effective in terms of the total dose of morphine administered, with dexmedetomidine recipients requiring less morphine than placebo recipients; with regard to patient management, dexmedetomidine recipients were calmer and easier to arouse and manage than placebo recipients. Intravenous dexmedetomidine was effective as a primary sedative in two randomized, double-blind, placebo-controlled, multicentre studies in adult patients undergoing awake fibre-optic intubation or a variety of diagnostic or surgical procedures requiring monitored anaesthesia care. In one study, significantly fewer dexmedetomidine than placebo recipients required rescue sedation with intravenous midazolam to achieve and/or maintain optimal sedation; conversely, in another study, rescue sedation with intravenous midazolam was not required by significantly more dexmedetomidine than placebo recipients. Primary sedation with intravenous dexmedetomidine was also effective in terms of the secondary efficacy endpoints, including the mean total dose of midazolam and fentanyl administered and the percentage of patients requiring further sedation (in addition to dexmedetomidine or placebo and midazolam), with, for the most part, significant between-group differences observed in favour of dexmedetomidine over placebo. In general, no significant differences were observed between the dexmedetomidine and placebo treatment groups in the anaesthesiologists' assessment of ease of intubation, haemodynamic stability, patient cooperation and/or respiratory stability. Intravenous dexmedetomidine is generally well tolerated when utilized in mechanically ventilated patients in an intensive care setting and for procedural sedation in non-intubated patients. Dexmedetomidine is associated with a lower rate of postoperative delirium than midazolam or propofol; it is not associated with respiratory depression. While dexmedetomidine is associated with hypotension and bradycardia, both usually resolve without intervention. Thus, intravenous dexmedetomidine provides a further option as a short-term (<24 hours) primary sedative in mechanically ventilated adult patients in an intensive care setting and in non-intubated adult patients prior to and/or during surgical and other procedures.

Doing the right thing without being told: joint effects of initiative climate and general self-efficacy on employee proactive customer service performance.

PubMed

Raub, Steffen; Liao, Hui

2012-05-01

We developed and tested a cross-level model of the antecedents and outcomes of proactive customer service performance. Results from a field study of 900 frontline service employees and their supervisors in 74 establishments of a multinational hotel chain located in Europe, the Middle East, Africa, and Asia demonstrated measurement equivalence and suggested that, after controlling for service climate, initiative climate at the establishment level and general self-efficacy at the individual level predicted employee proactive customer service performance and interacted in a synergistic way. Results also showed that at the establishment level, controlling for service climate and collective general service performance, initiative climate was positively and indirectly associated with customer service satisfaction through the mediation of aggregated proactive customer service performance. We discuss important theoretical and practical implications of these findings. (PsycINFO Database Record (c) 2012 APA, all rights reserved).

The global tobacco disease pandemic: nature, causes, and cures.

PubMed

Warner, K E; Mackay, J

2006-01-01

Tobacco use kills 5 million citizens globally every year. The World Health Organization (WHO) projects that the number of deaths will double just 15 years from now. Tobacco will then constitute the leading cause of death in the developing world, as it already is in developed countries today. This paper describes the nature and extent of the tobacco pandemic, characteristics of the global tobacco industry, and national and international efforts to diminish the toll of tobacco. The review includes examination of the economic and political strategies employed by the multinational tobacco industry to increase cigarette consumption, as well as the policies that governments have adopted to combat smoking. The most promising development is the new Framework Convention on Tobacco Control, WHO's first-ever international health treaty. While aggressive tobacco control policies can and will diminish the toll of tobacco, the prospects for the foreseeable future appear grim.

Proactive sustainability strategy and corporate sustainability performance: The mediating effect of sustainability control systems.

PubMed

Wijethilake, Chaminda

2017-07-01

This study examines to what extent corporations use sustainability control systems (SCS) to translate proactive sustainability strategy into corporate sustainability performance. The study investigates the mediating effect of SCS on the relationship between proactive sustainability strategy and corporate sustainability performance. Survey data were collected from top managers in 175 multinational and local corporations operating in Sri Lanka and analyzed using Partial Least Squares Structural Equation Modeling (PLS-SEM). SCS were observed to only partially mediate the relationship between proactive sustainability strategy and corporate sustainability performance. The mediating effect of SCS is further examined under three sustainability strategies; environmental and social strategies reveal a partial mediation, while the economic strategy exhibits no mediation. The study also finds that (i) a proactive sustainability strategy is positively associated with SCS and corporate sustainability performance and (ii) SCS are positively associated with corporate sustainability performance. Copyright © 2017 Elsevier Ltd. All rights reserved.

The human rights responsibilities of multinational tobacco companies

PubMed Central

Crow, M

2005-01-01

This article explores various strategies which could be used to hold the tobacco industry accountable for human rights violations precipitated by its conduct. First, a brief overview of the international human rights regime and the tobacco related jurisprudence issued by human rights treaty bodies is provided. The article then explains how tobacco control advocates could promote more systematic consideration of governments' tobacco related human rights violations by reconceptualising the Framework Convention on Tobacco Control in the language of rights. The feasibility of using the existing human rights framework to target the tobacco industry directly is analysed with the conclusion that this approach has serious limitations. Emerging human rights norms, which have greater potential to affect the industry's conduct, are presented. Finally, given the questionable authoritativeness of these norms, alternative ways that they could be employed to hold tobacco companies accountable for the rights related consequences of their activities are proposed. PMID:16046696

Organizational Wellness Program Implementation and Evaluation: A Holistic Approach to Improve the Wellbeing of Middle Managers.

PubMed

Medina, Maria Del Consuelo; Calderon, Angelica; Blunk, Dan I; Mills, Brandy W; Leiner, Marie

2018-06-01

: Employee wellness programs can provide benefits to institutions as well as employees and their families. Despite the attempts of some organizations to implement programs that take a holistic approach to improve physical, mental, and social wellness, the most common programs are exclusively comprised of physical and nutritional components. In this study, we implemented a wellness program intervention, including training using a holistic approach to improve the wellbeing of middle managers in several multinational organizations. We included control and experimental groups to measure wellness and teamwork with two repeated measures. Our results indicated that employees receiving the intervention had improved measures of wellness and teamwork. A positive relationship was found between wellness and teamwork in the experimental group when compared with the control group. Taken together, the data suggest that implementation of these programs would provide valuable outcomes for both employees and organizations.

Major multinational food and beverage companies and informal sector contributions to global food consumption: implications for nutrition policy.

PubMed

Alexander, Eleanore; Yach, Derek; Mensah, George A

2011-08-01

In recent years, 10 major multinational food and beverage companies have worked together within the International Food and Beverage Alliance (IFBA) to increase their commitments to public health. Current IFBA commitments include initiatives to improve the nutrition quality of products and how these products are advertised to children. The impact and magnitude of IFBA member contributions to the total market share of packaged foods and beverages consumed remain incompletely understood, however. In order to evaluate this impact, we examined packaged food and soft drink company shares provided by Euromonitor, an international independent market analysis company. Packaged foods include baby food, bakery, canned/preserved food, chilled/processed food, confectionery, dairy, dried processed food, frozen processed food, ice cream, meal replacement, noodles, oils and fats, pasta, ready meals, sauces, dressings and condiments, snack bars, soup, spreads, and sweet and savoury snacks. Soft drinks include carbonates, packaged fruit/vegetable juice, bottled water, functional drinks, concentrates, ready-to-drink tea, ready-to-drink coffee and Asian specialty drinks. We calculated the market shares for IFBA companies, globally and within nine countries--the US, China, India, Egypt, South Africa, Brazil, Mexico, Turkey and the UK. Worldwide, the top ten packaged food companies account for 15.2% of sales, with each individual company contributing less than 3.3%. The top ten soft drink companies account for 52.3% of sales worldwide; Coca-Cola and PepsiCo lead with 25.9% and 11.5% of sales, respectively. Although the top ten soft drink companies account for half of global sales, the top ten packaged food companies account for only a small proportion of market share with most individual companies contributing less than 3.3% each. Major multinational companies need to be joined by the myriad of small- and medium-sized enterprises in developing and implementing programs to improve the health of the public, globally. Without full participation of these companies, the impact of commitments made by IFBA members and other major multinational food and beverage companies will remain limited.

Unsafe sexual behaviour in domestic and foreign migrant male workers in multinational workplaces in Jordan: occupational-based and behavioural assessment survey.

PubMed

Al Rifai, Rami; Nakamura, Keiko; Seino, Kaoruko; Kizuki, Masashi; Morita, Ayako

2015-06-11

To examine the prevalence of unsafe sexual behaviour, sexually transmitted infection (STI)-related knowledge, health and work-related conditions, and correlates of practising unsafe sex among domestic and foreign male workers in multinational workplaces in Jordan. Cross-sectional behavioural assessment survey. Multinational workplaces in Jordan. 230 Jordanian and 480 foreign male workers aged ≥ 18 years who had worked in a Qualified Industrial Zone (QIZ) for 12 months or more. The primary outcome was the prevalence of practising unsafe sex. 'Unsafe sex' was defined as sex with a non-regular sexual partner with inconsistent condom usage. Overall, 74.3% of workers reported lifetime sexual experience. The proportion of lifetime unsafe sex was similar among domestic (31.8%) and foreign (35.6%) workers. Of those, 59.2% of domestic and 68.1% of foreign workers started practising unsafe sex after joining the QIZ. Rates of lifetime unsafe sex were significantly higher among those who had their sexual debut after joining the QIZ in domestic (aOR, 2.2, 95% CI 1.1 to 4.4) and foreign workers (aOR, 2.4, 95% CI 1.4 to 4.1). Among the domestic workers, being 18-24 years old (aOR, 4.9), unmarried (aOR, 4.8), working in the QIZ for 5-8 years (aOR, 5.0), sometimes/frequently shopped with foreign workers (aOR, 2.1) or were current/ex-alcohol drinkers (aORs, 3.4) were independently significantly associated with higher odds of practising unsafe sex. A significant proportion of domestic and foreign male workers had been practising unsafe sex. The findings indicated that not only foreigners but also domestic male workers associating with foreign workers are at high risk of unsafe sex. Tailored interventions to promote safer sex in multinational workplaces in Jordan are needed. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://group.bmj.com/group/rights-licensing/permissions.

Major multinational food and beverage companies and informal sector contributions to global food consumption: implications for nutrition policy

PubMed Central

2011-01-01

Background In recent years, 10 major multinational food and beverage companies have worked together within the International Food and Beverage Alliance (IFBA) to increase their commitments to public health. Current IFBA commitments include initiatives to improve the nutrition quality of products and how these products are advertised to children. The impact and magnitude of IFBA member contributions to the total market share of packaged foods and beverages consumed remain incompletely understood, however. Methods In order to evaluate this impact, we examined packaged food and soft drink company shares provided by Euromonitor, an international independent market analysis company. Packaged foods include baby food, bakery, canned/preserved food, chilled/processed food, confectionery, dairy, dried processed food, frozen processed food, ice cream, meal replacement, noodles, oils and fats, pasta, ready meals, sauces, dressings and condiments, snack bars, soup, spreads, and sweet and savoury snacks. Soft drinks include carbonates, packaged fruit/vegetable juice, bottled water, functional drinks, concentrates, ready-to-drink tea, ready-to-drink coffee and Asian specialty drinks. We calculated the market shares for IFBA companies, globally and within nine countries--the US, China, India, Egypt, South Africa, Brazil, Mexico, Turkey and the UK. Results Worldwide, the top ten packaged food companies account for 15.2% of sales, with each individual company contributing less than 3.3%. The top ten soft drink companies account for 52.3% of sales worldwide; Coca-Cola and PepsiCo lead with 25.9% and 11.5% of sales, respectively. Conclusions Although the top ten soft drink companies account for half of global sales, the top ten packaged food companies account for only a small proportion of market share with most individual companies contributing less than 3.3% each. Major multinational companies need to be joined by the myriad of small- and medium-sized enterprises in developing and implementing programs to improve the health of the public, globally. Without full participation of these companies, the impact of commitments made by IFBA members and other major multinational food and beverage companies will remain limited. PMID:21806827

Neuroendocrine Disorders in Pediatric Craniopharyngioma Patients

PubMed Central

Daubenbüchel, Anna M. M.; Müller, Hermann L.

2015-01-01

Childhood-onset craniopharyngiomas are partly cystic embryonic malformations of the sellar/parasellar region. The therapy of choice in patients with favorable tumor localization is complete resection with a specific focus on maintaining optical and hypothalamic neuroendocrine functions. In patients with unfavorable tumor localization (i.e., hypothalamic involvement), a limited hypothalamus-sparing surgical strategy followed by local irradiation is recommended. Involvement and/or surgical lesions of posterior hypothalamic areas cause major neuroendocrine sequelae. The overall survival rates are high (92%) but neuroendocrine disorders such as obesity and metabolic syndrome due to involvement and/or treatment-related hypothalamic lesions have major negative impact on survival and quality of life. Recurrences and progressions are frequent post-surgical events. Because irradiation is efficient in preventing tumor progression, appropriate timing of post-surgical irradiation is currently under investigation in a randomized multinational trial (KRANIOPHARYNGEOM 2007). Childhood-onset craniopharyngioma should be recognized as a chronic disease requiring treatment and constant monitoring of the clinical and quality of life consequences, frequently impaired due to neuroendocrine disorders, by experienced multidisciplinary teams in order to provide optimal care of surviving patients. PMID:26239246

The Role of Energy Balance in Successful Aging Among Elderly Individuals: The Multinational MEDIS Study.

PubMed

Tyrovolas, Stefanos; Haro, Josep Maria; Mariolis, Anargiros; Piscopo, Suzanne; Valacchi, Giuseppe; Makri, Kornilia; Zeimbekis, Akis; Tyrovola, Dimitra; Bountziouka, Vassiliki; Gotsis, Efthimios; Metallinos, George; Tur, Josep-Antoni; Matalas, Antonia; Lionis, Christos; Polychronopoulos, Evangelos; Panagiotakos, Demosthenes

2015-12-01

The determinants that promote living beyond life expectancy and successful aging still remain unknown. The aim of the present work was to evaluate the role of energy balance in successful aging, in a random sample of older adults living in the Mediterranean basin. During 2005 to 2011, 2,663 older (aged 65-100 years) adults from 21 Mediterranean islands and the rural Mani region (Peloponnesus) of Greece were voluntarily enrolled in the study. Dietary habits, energy intake, expenditure, and energy balance were derived throughout standard procedures. A successful aging index (range = 0-10) was used. After adjusting for several confounders, high energy intake (i.e., >1,700 kcal/day), b-coefficient [95% CI] = -0.21[-0.37, -0.05], as well as positive energy balance, b-coefficient [95% CI] = -0.21 [-0.37, -0.05], were inversely associated with successful aging. A diet with excessive energy intake and a positive energy balance seems to be associated with lower quality of life, as measured through successful aging. © The Author(s) 2015.

ECLAMC Study: prevalence patterns of hypospadias in South America: multi-national analysis over a 24-year period

PubMed Central

Fernández, Nicolás; Pérez, Jaime; Monterrey, Pedro; Poletta, Fernando A.; Bägli, Darius J.; Lorenzo, Armando J.; Zarante, Ignacio

2017-01-01

ABSTRACT Objective To evaluate prevalence trends of hypospadias in South-America it is essential to perform multicenter and multinational studies with the same methodology. Herein we present systematic data as part of an international multicenter initiative evaluating congenital malformations in South America over a 24-year period. Materials and Methods A nested case-control study was conducted using the Latin American Collaborative Study of Congenital Malformations (ECLAMC), between January 1989 and December 2012. Cases were stratified as isolated (IH) and non-isolated hypospadias (NIH). Global prevalence was calculated and discriminated by country. Associations between birth weight and gestational age, and NIH distribution by associated abnormality and severity of hypospadias, were analyzed. Results A total of 159 hospitals from six countries participated, reporting surveillance on 4.020.384 newborns. A total of 4.537 hypospadias cases were detected, with a global prevalence of 11.3/10.000 newborns. Trend analyses showed in Chile, Brazil and Uruguay a statistically significant increase in prevalence. Analysis of severity and associated anomalies did not to find an association for distal cases, but did for proximal (RR=1.64 [95% CI=1.33-2.03]). Conclusion This is one of only a few Latin American multicenter studies reporting on the epidemiology of hypospadias in South America in the last two decades. Our data adds to evidence suggesting an increase in some countries in the region at different times. There were also variations in prevalence according to severity. This study adds to literature describing associated anomalies at a hospital-based level. PMID:27802003

ECLAMC Study: Prevalence patterns of hypospadias in South America: Multi-national analysis over a 24-year period.

PubMed

Fernández, Nicolás; Pérez, Jaime; Monterrey, Pedro; Poletta, Fernando A; Bägli, Darius J; Lorenzo, Armando J; Zarante, Ignacio

2017-01-01

To evaluate prevalence trends of hypospadias in South-America it is essential to perform multicenter and multinational studies with the same methodology. Herein we present systematic data as part of an international multicenter initiative evaluating congenital malformations in South America over a 24-year period. A nested case-control study was conducted using the Latin American Collaborative Study of Congenital Malformations (ECLAMC), between January 1989 and December 2012. Cases were stratified as isolated (IH) and non-isolated hypospadias (NIH). Global prevalence was calculated and discriminated by country. Associations between birth weight and gestational age, and NIH distribution by associated abnormality and severity of hypospadias, were analyzed. A total of 159 hospitals from six countries participated, reporting surveillance on 4.020.384 newborns. A total of 4.537 hypospadias cases were detected, with a global prevalence of 11.3/10.000 newborns. Trend analyses showed in Chile, Brazil and Uruguay a statistically significant increase in prevalence. Analysis of severity and associated anomalies did not to find an association for distal cases, but did for proximal (RR=1.64 [95% CI=1.33-2.03]). This is one of only a few Latin American multicenter studies reporting on the epidemiology of hypospadias in South America in the last two decades. Our data adds to evidence suggesting an increase in some countries in the region at different times. There were also variations in prevalence according to severity. This study adds to literature describing associated anomalies at a hospital-based level. Copyright® by the International Brazilian Journal of Urology.

How to handle multidisciplinary, multi-national and multi-sectoral projects

NASA Astrophysics Data System (ADS)

Reitz, Anja; Wallmann, Klaus; Visbeck, Martin

2016-04-01

Collaborative research projects funded by the European Commission are by nature multi-national. Often they bring together different scientific communities as the questions raised in EU project calls can typically only be addressed through the convergence of these previously separated disciplines in one research consortium. Some work programmes even necessitate to team up as different disciplines as natural sciences, social science, legal science and economic science. Examples for such multi- national, -disciplinary and - sectoral projects are the EU projects ECO2 (FP7, concluded) and AtlantOS (H2020). Project managers of such projects need to develop skills beyond the common technical and management skills namely go into the domain of partners and stakeholders psychology and be able to maintain different perspectives on communication and interaction needs regarding cultural-, discipline- and sectoral background. Accordingly, the project manager has besides his technical role as manager at least three further roles: that of a communicator, that of a mediator and that of a person convincing partners of the necessary and selling the project products to the stakeholders. As the typical project manager has not too much power and authority by his position he has to use the power of smart communication and persuasion to overcome potential dissension between disciplines, national reservation or potential conflicts regarding different sectoral views. Accordingly, the project manager of such a complex project would try to arrange the ideal working environment by considering cultural feel, the cooperation of disciplines, information and the control of resources. The way he develops such ideal working environment is by reflection of past, present and future experiences/needs.

Abiraterone Improves Survival in Metastatic Prostate Cancer

Cancer.gov

A multinational phase III trial found that the drug abiraterone acetate prolonged the median survival of patients with metastatic castration-resistant prostate cancer by 4 months compared with patients who received a placebo.

Direct Foreign Investment in the United Kingdom.

ERIC Educational Resources Information Center

Hinde, Kevin

1987-01-01

Notes introductory undergraduate economics textbooks have no formal analysis of the rationale for direct foreign investment by multinational firms. Examines this area in an attempt to develop more content information for undergraduate courses. (RKM)

Multinational Species Conservation Funds Reauthorization Act of 2013

THOMAS, 113th Congress

Rep. Young, Don [R-AK-At Large

2013-01-03

House - 01/31/2013 Referred to the Subcommittee on Fisheries, Wildlife, Oceans, and Insular Affairs. (All Actions) Tracker: This bill has the status IntroducedHere are the steps for Status of Legislation:

Multinational Species Conservation Funds Semipostal Stamp Reauthorization Act

THOMAS, 113th Congress

Rep. Grimm, Michael G. [R-NY-11

2013-01-15

House - 01/31/2013 Referred to the Subcommittee on Fisheries, Wildlife, Oceans, and Insular Affairs. (All Actions) Tracker: This bill has the status IntroducedHere are the steps for Status of Legislation:

Multinational Species Conservation Funds Semipostal Stamp Reauthorization Act

THOMAS, 112th Congress

Rep. Grimm, Michael G. [R-NY-13

2011-11-29

House - 12/05/2011 Referred to the Subcommittee on Fisheries, Wildlife, Oceans, and Insular Affairs. (All Actions) Tracker: This bill has the status IntroducedHere are the steps for Status of Legislation:

Limitations on Disclosure of Information under Pesticide Law

EPA Pesticide Factsheets

Pesticide law limits disclosure of information if it contains confidential information or if the requester is a multinational entity. This Web page provides information on these issues and how they affect information disclosure.

Environmental due diligence within multinational corporations

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

MacLean, R.

1997-08-01

Superfund and other state and federal regulations that emerged during the 80`s dramatically changed the way corporations managed property transactions. At the beginning of that decade there were very few engineers experienced in environmental due diligence. Over the past 15 years a sophisticated consulting industry has emerged to support companies in their effort to minimize liabilities associated with contaminated property. There is now a wealth of published literature on environmental due diligence, including generally accepted standards for investigating property contamination from organizations such as ASTM. This paper examines the current state of environmental due diligence among multinationals. It presents themore » underlying reasons for the current ad hoc nature of due diligence investigations and what companies can do to improve their policies and communication networks. A summary is given of the best practices used by industry leaders to minimize liabilities.« less

Qualifizierung für "Industrie 4.0". Facharbeit in Deutschland und deutschen Auslandsniederlassungen in Emerging Economies

NASA Astrophysics Data System (ADS)

Fuchs, Martina; Pilz, Matthias; Wiemann, Judith; Wiemann, Kristina

2017-06-01

Frey and Osbourne's (2013) notion of the end of professional technical skills caused by Industry 4.0 (smart manufacturing), also known as increasing polarisation into "lousy and lovely jobs", is a topical issue. This contribution is a critical review of this idea in the context of German multinational companies, many of which are intensifying their efforts to introduce international customer-oriented quality production, digital high-tech and new human-machine-interfaces. Such high-tech production requires that the companies further internationalise practices of the German technical vocational education and training to emerging economies as Mexico, India and China. For German multinational companies this rather suggests an increase in professional technical skills (also on an international level) and less so rationalisation potentials in this particular segment of production work.

Multi-National Banknote Classification Based on Visible-light Line Sensor and Convolutional Neural Network.

PubMed

Pham, Tuyen Danh; Lee, Dong Eun; Park, Kang Ryoung

2017-07-08

Automatic recognition of banknotes is applied in payment facilities, such as automated teller machines (ATMs) and banknote counters. Besides the popular approaches that focus on studying the methods applied to various individual types of currencies, there have been studies conducted on simultaneous classification of banknotes from multiple countries. However, their methods were conducted with limited numbers of banknote images, national currencies, and denominations. To address this issue, we propose a multi-national banknote classification method based on visible-light banknote images captured by a one-dimensional line sensor and classified by a convolutional neural network (CNN) considering the size information of each denomination. Experiments conducted on the combined banknote image database of six countries with 62 denominations gave a classification accuracy of 100%, and results show that our proposed algorithm outperforms previous methods.

Multi-National Banknote Classification Based on Visible-light Line Sensor and Convolutional Neural Network

PubMed Central

Pham, Tuyen Danh; Lee, Dong Eun; Park, Kang Ryoung

2017-01-01

Automatic recognition of banknotes is applied in payment facilities, such as automated teller machines (ATMs) and banknote counters. Besides the popular approaches that focus on studying the methods applied to various individual types of currencies, there have been studies conducted on simultaneous classification of banknotes from multiple countries. However, their methods were conducted with limited numbers of banknote images, national currencies, and denominations. To address this issue, we propose a multi-national banknote classification method based on visible-light banknote images captured by a one-dimensional line sensor and classified by a convolutional neural network (CNN) considering the size information of each denomination. Experiments conducted on the combined banknote image database of six countries with 62 denominations gave a classification accuracy of 100%, and results show that our proposed algorithm outperforms previous methods. PMID:28698466

Competing with giants. Survival strategies for local companies in emerging markets.

PubMed

Dawar, N; Frost, T

1999-01-01

The arrival of a multinational corporation often looks like a death sentence to local companies in an emerging market. After all, how can they compete in the face of the vast financial and technological resources, the seasoned management, and the powerful brands of, say, a Compaq or a Johnson & Johnson? But local companies often have more options than they might think, say the authors. Those options vary, depending on the strength of globalization pressures in an industry and the nature of a company's competitive assets. In the worst case, when globalization pressures are strong and a company has no competitive assets that it can transfer to other countries, it needs to retreat to a locally oriented link within the value chain. But if globalization pressures are weak, the company may be able to defend its market share by leveraging the advantages it enjoys in its home market. Many companies in emerging markets have assets that can work well in other countries. Those that operate in industries where the pressures to globalize are weak may be able to extend their success to a limited number of other markets that are similar to their home base. And those operating in global markets may be able to contend head-on with multinational rivals. By better understanding the relationship between their company's assets and the industry they operate in, executives from emerging markets can gain a clearer picture of the options they really have when multinationals come to stay.

Using multilevel models for assessing the variability of multinational resource use and cost data.

PubMed

Grieve, Richard; Nixon, Richard; Thompson, Simon G; Normand, Charles

2005-02-01

Multinational economic evaluations often calculate a single measure of cost-effectiveness using cost data pooled across several countries. To assess the validity of pooling international cost data the reasons for cost variation across countries need to be assessed. Previously, ordinary least-squares (OLS) regression models have been used to identify factors associated with variability in resource use and total costs. However, multilevel models (MLMs), which accommodate the hierarchical structure of the data, may be more appropriate. This paper compares these different techniques using a multinational dataset comprising case-mix, resource use and cost data on 1300 stroke admissions from 13 centres in 11 European countries. OLS and MLMs were used to estimate the effect of patient and centre-level covariates on the total length of hospital stay (LOS) and total cost. MLMs with normal and gamma distributions for the data within centres were compared. The results from the OLS model showed that both patient and centre-level covariates were associated with LOS and total cost. The estimates from the MLMs showed that none of the centre-level characteristics were associated with LOS, and the level of spending on health was the centre-level variable most highly associated with total cost. We conclude that using OLS models for assessing international variation can lead to incorrect inferences, and that MLMs are more appropriate for assessing why resource use and costs vary across centres. Copyright (c) 2004 John Wiley & Sons, Ltd.

Resource costing for multinational neurologic clinical trials: methods and results.

PubMed

Schulman, K; Burke, J; Drummond, M; Davies, L; Carlsson, P; Gruger, J; Harris, A; Lucioni, C; Gisbert, R; Llana, T; Tom, E; Bloom, B; Willke, R; Glick, H

1998-11-01

We present the results of a multinational resource costing study for a prospective economic evaluation of a new medical technology for treatment of subarachnoid hemorrhage within a clinical trial. The study describes a framework for the collection and analysis of international resource cost data that can contribute to a consistent and accurate intercountry estimation of cost. Of the 15 countries that participated in the clinical trial, we collected cost information in the following seven: Australia, France, Germany, the UK, Italy, Spain, and Sweden. The collection of cost data in these countries was structured through the use of worksheets to provide accurate and efficient cost reporting. We converted total average costs to average variable costs and then aggregated the data to develop study unit costs. When unit costs were unavailable, we developed an index table, based on a market-basket approach, to estimate unit costs. To estimate the cost of a given procedure, the market-basket estimation process required that cost information be available for at least one country. When cost information was unavailable in all countries for a given procedure, we estimated costs using a method based on physician-work and practice-expense resource-based relative value units. Finally, we converted study unit costs to a common currency using purchasing power parity measures. Through this costing exercise we developed a set of unit costs for patient services and per diem hospital services. We conclude by discussing the implications of our costing exercise and suggest guidelines to facilitate more effective multinational costing exercises.

NEPA, a fixed oral combination of netupitant and palonosetron, improves control of chemotherapy-induced nausea and vomiting (CINV) over multiple cycles of chemotherapy: results of a randomized, double-blind, phase 3 trial versus oral palonosetron.

PubMed

Aapro, Matti; Karthaus, Meinolf; Schwartzberg, Lee; Bondarenko, Igor; Sarosiek, Tomasz; Oprean, Cristina; Cardona-Huerta, Servando; Hansen, Vincent; Rossi, Giorgia; Rizzi, Giada; Borroni, Maria Elisa; Rugo, Hope

2017-04-01

Antiemetic guidelines recommend co-administration of targeted prophylactic medications inhibiting molecular pathways involved in emesis. NEPA is a fixed oral combination of a new NK 1 receptor antagonist (RA), netupitant (NETU 300 mg), and palonosetron (PALO 0.50 mg), a pharmacologically distinct 5-HT 3 RA. NEPA showed superior prevention of chemotherapy-induced nausea and vomiting (CINV) compared with oral PALO in a single chemotherapy cycle; maintenance of efficacy/safety over continuing cycles is the objective of this study. This study is a multinational, double-blind study comparing a single oral dose of NEPA vs oral PALO in chemotherapy-naïve patients receiving anthracycline/cyclophosphamide-based chemotherapy along with dexamethasone 12 mg (NEPA) or 20 mg (PALO) on day 1. The primary efficacy endpoint was delayed (25-120 h) complete response (CR: no emesis, no rescue medication) in cycle 1. Sustained efficacy was evaluated during the multicycle extension by calculating the proportion of patients with overall (0-120 h) CR in cycles 2-4 and by assessing the probability of sustained CR over multiple cycles. Of 1455 patients randomized, 1286 (88 %) participated in the multiple-cycle extension for a total of 5969 cycles; 76 % completed ≥4 cycles. The proportion of patients with an overall CR was significantly greater for NEPA than oral PALO for cycles 1-4 (74.3 vs 66.6 %, 80.3 vs 66.7 %, 83.8 vs 70.3 %, and 83.8 vs 74.6 %, respectively; p ≤ 0.001 each cycle). The cumulative percentage of patients with a sustained CR over all 4 cycles was also greater for NEPA (p < 0.0001). NEPA was well tolerated over cycles. NEPA, a convenient, guideline-consistent, fixed antiemetic combination is effective and safe over multiple cycles of chemotherapy.

Efficacy of oral palonosetron compared to intravenous palonosetron for the prevention of chemotherapy-induced nausea and vomiting associated with moderately emetogenic chemotherapy: a phase 3 trial.

PubMed

Boccia, Ralph; Grunberg, Steven; Franco-Gonzales, Edwin; Rubenstein, Edward; Voisin, Daniel

2013-05-01

Palonosetron (Aloxi(®), Onicit(®)) is a pharmacologically unique 5-HT3 receptor antagonist (RA) approved as a single IV injection for the prevention of nausea and vomiting induced by chemotherapy (CINV) of either moderate or highly emetogenic potential (MEC and HEC, respectively). An oral palonosetron formulation has been developed and compared to the IV formulation. In this multinational, multicenter, double-blind, double-dummy, dose-ranging trial, 651 patients were randomly assigned to receive one of the following as a single dose prior to moderately emetogenic chemotherapy: oral palonosetron 0.25, 0.50, and 0.75 mg or IV palonosetron 0.25 mg. Patients were also randomized (1:1) to receive dexamethasone 8 mg IV or matched placebo on day 1. The primary endpoint was complete response (CR; no emesis, no rescue therapy) during the acute phase (0-24 h). Acute CR rates were 73.5, 76.3, 74.1, and 70.4 % for all patients receiving the palonosetron 0.25, 0.50, and 0.75 mg oral doses, and for IV palonosetron 0.25 mg, respectively; delayed CR (24-120 h) rates were 59.4, 62.5, 60.1, and 65.4 %, and overall CR (0-120 h) rates were 53.5, 58.8, 53.2, and 59.3 %, respectively. The addition of dexamethasone improved emetic control (acute CR rate) by at least 15 % for all groups except oral palonosetron 0.25 mg, where the acute CR improvement was approximately 7 %. Adverse events were similar in nature, incidence, and intensity for all oral and IV palonosetron groups, and were the expected adverse events for 5-HT3 RAs (primarily headache and constipation). Oral palonosetron has a similar efficacy and safety profile as IV palonosetron 0.25 mg and may be the preferred formulation in certain clinical situations. Among the tested oral treatments, a palonosetron 0.50-mg oral dose has been favored for the prevention of CINV in patients receiving moderately emetogenic chemotherapy due to a numerical gain in efficacy without a side effect disadvantage.

Relative Efficacy of AS03-Adjuvanted Pandemic Influenza A(H1N1) Vaccine in Children: Results of a Controlled, Randomized Efficacy Trial

PubMed Central

Nolan, Terry; Roy-Ghanta, Sumita; Montellano, May; Weckx, Lily; Ulloa-Gutierrez, Rolando; Lazcano-Ponce, Eduardo; Kerdpanich, Angkool; Safadi, Marco Aurélio Palazzi; Cruz-Valdez, Aurelio; Litao, Sandra; Lim, Fong Seng; de Los Santos, Abiel Mascareñas; Weber, Miguel Angel Rodriguez; Tinoco, Juan-Carlos; Mezerville, Marcela Hernandez-de; Faingezicht, Idis; Kosuwon, Pensri; Lopez, Pio; Borja-Tabora, Charissa; Li, Ping; Durviaux, Serge; Fries, Louis; Dubin, Gary; Breuer, Thomas; Innis, Bruce L.; Vaughn, David W.

2014-01-01

Background. The vaccine efficacy (VE) of 1 or 2 doses of AS03-adjuvanted influenza A(H1N1) vaccine relative to that of 2 doses of nonadjuvanted influenza A(H1N1) vaccine in children 6 months to <10 years of age in a multinational study conducted during 2010–2011. Methods. A total of 6145 children were randomly assigned at a ratio of 1:1:1 to receive 2 injections 21 days apart of A/California/7/2009(H1N1)-AS03 vaccine at dose 1 and saline placebo at dose 2, 2 doses 21 days apart of A/California/7/2009(H1N1)-AS03 vaccine (the Ad2 group), or 2 doses 21 days apart of nonadjuvanted A/California/7/2009(H1N1) vaccine (the NAd2 group). Active surveillance for influenza-like illnesses continued from days 14 to 385. Nose and throat samples obtained during influenza-like illnesses were tested for A/California/7/2009(H1N1), using reverse-transcriptase polymerase chain reaction. Immunogenicity, reactogenicity, and safety were assessed. Results. There were 23 cases of confirmed 2009 pandemic influenza A(H1N1) (A[H1N1]pdm09) infection for the primary relative VE analysis. The VE in the Ad2 group relative to that in the NAd2 group was 76.8% (95% confidence interval, 18.5%–93.4%). The benefit of the AS03 adjuvant was demonstrated in terms of the greater immunogenicity observed in the Ad2 group, compared with the NAd2 group. Conclusion. The 4–8-fold antigen-sparing adjuvanted pandemic influenza vaccine demonstrated superior and clinically important prevention of A(H1N1)pdm09 infection, compared with nonadjuvanted vaccine, with no observed increase in medically attended or serious adverse events. These data support the use of adjuvanted influenza vaccines during influenza pandemics. Clinical Trials Registration. NCT01051661. PMID:24652494

Safety and immunogenicity of an AS01-adjuvanted varicella-zoster virus subunit candidate vaccine against herpes zoster in adults >=50 years of age.

PubMed

Chlibek, Roman; Bayas, José M; Collins, Harry; de la Pinta, Maria Luisa Rodriguez; Ledent, Edouard; Mols, Johann F; Heineman, Thomas C

2013-12-15

An adjuvanted varicella-zoster virus glycoprotein E (gE) subunit vaccine candidate for herpes zoster is in development. In this trial we compared the safety, reactogenicity, and immunogenicity of the vaccine antigen combined with different adjuvant doses. This was a phase II, observer-blind, randomized, multinational study. Adults ≥50 years old were randomized 4:4:2:1 to be vaccinated at months 0 and 2 with gE combined with a higher (AS01B) or lower (AS01E) dose adjuvant, unadjuvanted gE, or saline. Following each dose, solicited events were recorded for 7 days and unsolicited adverse events for 30 days. Serious adverse events were collected for 1 year. Cell-mediated and humoral immune responses were assessed at baseline and following each dose. No vaccine-related severe adverse events were reported. Solicited adverse events were generally mild to moderate and transient. For all gE-based vaccines, pain was the most common local symptom and fatigue the most common general symptom. Immune responses were significantly enhanced by AS01B and AS01E compared to unadjuvanted gE and were significantly stronger for gE/AS01B than for gE/AS01E. AS01 improved the immunogenicity of gE while retaining acceptable safety and reactogenicity profiles. The enhancement of gE-specific cellular and humoral responses was adjuvant dose dependent. NCT00802464.

Evaluating the importance of policy amenable factors in explaining influenza vaccination: a cross-sectional multinational study.

PubMed

Wheelock, Ana; Miraldo, Marisa; Thomson, Angus; Vincent, Charles; Sevdalis, Nick

2017-07-12

Despite continuous efforts to improve influenza vaccination coverage, uptake among high-risk groups remains suboptimal. We aimed to identify policy amenable factors associated with vaccination and to measure their importance in order to assist in the monitoring of vaccination sentiment and the design of communication strategies and interventions to improve vaccination rates. The USA, the UK and France. A total of 2412 participants were surveyed across the three countries. Self-reported influenza vaccination. Between March and April 2014, a stratified random sampling strategy was employed with the aim of obtaining nationally representative samples in the USA, the UK and France through online databases and random-digit dialling. Participants were asked about vaccination practices, perceptions and feelings. Multivariable logistic regression was used to identify factors associated with past influenza vaccination. The models were able to explain 64%-80% of the variance in vaccination behaviour. Overall, sociopsychological variables, which are inherently amenable to policy, were better at explaining past vaccination behaviour than demographic, socioeconomic and health variables. Explanatory variables included social influence (physician), influenza and vaccine risk perceptions and traumatic childhood experiences. Our results indicate that evidence-based sociopsychological items should be considered for inclusion into national immunisation surveys to gauge the public's views, identify emerging concerns and thus proactively and opportunely address potential barriers and harness vaccination drivers. © Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2017. All rights reserved. No commercial use is permitted unless otherwise expressly granted.

Variations in locoregional therapy in postmenopausal patients with early breast cancer treated in different countries.

PubMed

van Nes, J G H; Seynaeve, C; Jones, S; Markopoulos, C; Putter, H; van de Velde, C J H; Hasenburg, A; Rea, D W; Vannetzel, J-M; Dirix, L; Hozumi, Y; Kerin, M J; Kieback, D G; Meershoek-Klein Kranenbarg, W M; Hille, E T M; Nortier, J W R

2010-05-01

The Tamoxifen and Exemestane Adjuvant Multinational (TEAM) trial is an international randomized trial evaluating the efficacy and safety of exemestane, alone or following tamoxifen. The large number of patients already recruited offered the opportunity to explore locoregional treatment practices between countries. Patients were enrolled in Belgium, France, Germany, Greece, Ireland, Japan, the Netherlands, the UK and the USA. The core protocol had minor differences in eligibility criteria between countries, reflecting variations in national guidelines and practice regarding adjuvant endocrine therapy. Between 2001 and 2006, 9779 patients of mean(s.d.) age 64(9) years were randomized. Some 58.4 per cent had T1 tumours (range between countries 36.8-75.9 per cent; P < 0.001) and 47.3 per cent were axillary node positive (range 25.9-84.6 per cent; P < 0.001). Independent factors for type of breast surgery were country, age, tumour status and calendar year of surgery. After breast-conserving surgery, radiotherapy was given to 93.2 per cent of patients, 86.0 per cent in the USA and 100 per cent in France. Axillary lymph node dissection was performed in 82.0 (range 74.6-99.1) per cent. Despite international consensus guidelines, wide global variations were observed in treatment practices of early breast cancer. There should be further efforts to optimize locoregional treatment for breast cancer worldwide. Copyright 2010 British Journal of Surgery Society Ltd.

Further analysis of PREVAIL: enzalutamide use in chemotherapy-naïve men with metastatic castration-resistant prostate cancer

PubMed Central

Aragon-Ching, Jeanny B

2014-01-01

PREVAIL was a phase III multinational, double-blind, placebo-controlled trial that enrolled chemotherapy-naïve men with metastatic castration-resistant prostate cancer (mCRPC), which showed remarkable improvement in co-primary endpoints with an overall 81% reduction in the risk of radiographic progression, as well as 29% reduction in the risk of death in favor of the enzalutamide arm over placebo. All secondary endpoints including time to subsequent chemotherapy initiation and prostate specific antigen (PSA) progression were in favor of the enzalutamide arm. The results of PREVAIL shows the utility of enzalutamide that would likely soon expand the indication to asymptomatic or minimally symptomatic men with mCRPC not previously treated with chemotherapy. PMID:25080931

Further analysis of PREVAIL: enzalutamide use in chemotherapy-naïve men with metastatic castration-resistant prostate cancer.

PubMed

Aragon-Ching, Jeanny B

2014-01-01

PREVAIL was a phase III multinational, double-blind, placebo-controlled trial that enrolled chemotherapy-naïve men with metastatic castration-resistant prostate cancer (mCRPC), which showed remarkable improvement in co-primary endpoints with an overall 81% reduction in the risk of radiographic progression, as well as 29% reduction in the risk of death in favor of the enzalutamide arm over placebo. All secondary endpoints including time to subsequent chemotherapy initiation and prostate specific antigen (PSA) progression were in favor of the enzalutamide arm. The results of PREVAIL shows the utility of enzalutamide that would likely soon expand the indication to asymptomatic or minimally symptomatic men with mCRPC not previously treated with chemotherapy.

Social marketing: the family planning experience.

PubMed

El-ansary, A I; Kramer Oe, J

1973-07-01

The authors explore social marketing applications in the Louisiana model of statewide program for family planning. The marketing concept has 4 major elements: 1) consumer orientation; 2) social process; 3) integrated effort; 4) profitable operation. Success of program and continued growth are the results of defining services needed by consumer; determining market target; taking services to customer; and emphasizing concept of selling family planning rather than giving free birth control method. Another important facet is the recognition of many participants--community agencies, the church, the American Medical Association, funding sources, and hospitals. This project used anyaltical marketing tools and defined services as human services rather than the narrow family planning services. It also extended activities to multinational environment and adapted the product offering to meet these needs.

Poverty and childhood undernutrition in developing countries: a multi-national cohort study.

PubMed

Petrou, Stavros; Kupek, Emil

2010-10-01

The importance of reducing childhood undernutrition has been enshrined in the United Nations' Millennium Development Goals. This study explores the relationship between alternative indicators of poverty and childhood undernutrition in developing countries within the context of a multi-national cohort study (Young Lives). Approximately 2000 children in each of four countries - Ethiopia, India (Andhra Pradesh), Peru and Vietnam - had their heights measured and were weighed when they were aged between 6 and 17 months (survey one) and again between 4.5 and 5.5 years (survey two). The anthropometric outcomes of stunted, underweight and wasted were calculated using World Health Organization 2006 reference standards. Maximum-likelihood probit estimation was employed to model the relationship within each country and survey between alternative measures of living standards (principally a wealth index developed using principal components analysis) and each anthropometric outcome. An extensive set of covariates was incorporated into the models to remove as much individual heterogeneity as possible. The fully adjusted models revealed a negative and statistically significant coefficient on wealth for all outcomes in all countries, with the exception of the outcome of wasted in India (Andhra Pradesh) and Vietnam (survey one) and the outcome of underweight in Vietnam (surveys one and two). In survey one, the partial effects of wealth on the probabilities of stunting, being underweight and wasting was to reduce them by between 1.4 and 5.1 percentage points, 1.0 and 6.4 percentage points, and 0.3 and 4.5 percentage points, respectively, with each unit (10%) increase in wealth. The partial effects of wealth on the probabilities of anthropometric outcomes were larger in the survey two models. In both surveys, children residing in the lowest wealth quintile households had significantly increased probabilities of being stunted in all four study countries and of being underweight in Ethiopia, India (Andhra Pradesh) and Peru in comparison to children residing in the highest wealth quintile households. Random effects probit models confirmed the statistical significance of increased wealth in reducing the probability of being stunted and underweight across all four study countries. We conclude that, although multi-faceted, childhood undernutrition in developing countries is strongly rooted in poverty.

Understanding factors associated with the translation of cardiovascular research: a multinational case study approach

PubMed Central

2014-01-01

Background Funders of health research increasingly seek to understand how best to allocate resources in order to achieve maximum value from their funding. We built an international consortium and developed a multinational case study approach to assess benefits arising from health research. We used that to facilitate analysis of factors in the production of research that might be associated with translating research findings into wider impacts, and the complexities involved. Methods We built on the Payback Framework and expanded its application through conducting co-ordinated case studies on the payback from cardiovascular and stroke research in Australia, Canada and the United Kingdom. We selected a stratified random sample of projects from leading medical research funders. We devised a series of innovative steps to: minimize the effect of researcher bias; rate the level of impacts identified in the case studies; and interrogate case study narratives to identify factors that correlated with achieving high or low levels of impact. Results Twenty-nine detailed case studies produced many and diverse impacts. Over the 15 to 20 years examined, basic biomedical research has a greater impact than clinical research in terms of academic impacts such as knowledge production and research capacity building. Clinical research has greater levels of wider impact on health policies, practice, and generating health gains. There was no correlation between knowledge production and wider impacts. We identified various factors associated with high impact. Interaction between researchers and practitioners and the public is associated with achieving high academic impact and translation into wider impacts, as is basic research conducted with a clinical focus. Strategic thinking by clinical researchers, in terms of thinking through pathways by which research could potentially be translated into practice, is associated with high wider impact. Finally, we identified the complexity of factors behind research translation that can arise in a single case. Conclusions We can systematically assess research impacts and use the findings to promote translation. Research funders can justify funding research of diverse types, but they should not assume academic impacts are proxies for wider impacts. They should encourage researchers to consider pathways towards impact and engage potential research users in research processes. PMID:24755187

Patients' values and preferences of the expected efficacy of hip arthroscopy for osteoarthritis: a protocol for a multinational structured interview-based study combined with a randomised survey on the optimal amount of information to elicit preferences.

PubMed

Zhang, Yuqing; Tikkinen, Kari A O; Agoritsas, Thomas; Ayeni, Olufemi R; Alexander, Paul; Imam, Maha; Yoo, Daniel; Tsalatsanis, Athanasios; Djulbegovic, Benjamin; Thabane, Lehana; Schünemann, Holger; Guyatt, Gordon H

2014-10-17

Symptomatic hip osteoarthritis (OA) is a disabling condition with up to a 25% cumulative lifetime risk. Total hip arthroplasty (THA) is effective in relieving patients' symptoms and improving function. It is, however, associated with substantial risk of complications, pain and major functional limitation before patients can return to full function. In contrast, hip arthroscopy (HA) is less invasive and can postpone THA. However, there is no evidence regarding the delay in the need for THA that patients would find acceptable to undergoing HA. Knowing patients' values and preferences (VP) on this expected delay is critical when making recommendations regarding the advisability of HA. Furthermore, little is known on the optimal amount of information regarding interventions and outcomes needed to present in order to optimally elicit patients' VP. We will perform a multinational, structured interview-based survey of preference in delay time for THA among patients with non-advanced OA who failed to respond to conservative therapy. We will combine these interviews with a randomised trial addressing the optimal amount of information regarding the interventions and outcomes required to elicit preferences. Eligible patients will be randomly assigned (1 : 1) to either a short or a long format of health scenarios of THA and HA. We will determine each patient's VP using a trade-off and anticipated regret exercises. Our primary outcomes for the combined surveys will be: (1) the minimal delay time in the need for THA surgery that patients would find acceptable to undertaking HA, (2) patients' satisfaction with the amount of information provided in the health scenarios used to elicit their VPs. The protocol has been approved by the Hamilton Integrated Research Ethics Board (HIREB13-506). We will disseminate our study findings through peer-reviewed publications and conference presentations, and make them available to guideline makers issuing recommendations addressing HA and THA. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://group.bmj.com/group/rights-licensing/permissions.

Patients’ values and preferences of the expected efficacy of hip arthroscopy for osteoarthritis: a protocol for a multinational structured interview-based study combined with a randomised survey on the optimal amount of information to elicit preferences

PubMed Central

Zhang, Yuqing; Tikkinen, Kari A O; Agoritsas, Thomas; Ayeni, Olufemi R; Alexander, Paul; Imam, Maha; Yoo, Daniel; Tsalatsanis, Athanasios; Djulbegovic, Benjamin; Thabane, Lehana; Schünemann, Holger; Guyatt, Gordon H

2014-01-01

Introduction Symptomatic hip osteoarthritis (OA) is a disabling condition with up to a 25% cumulative lifetime risk. Total hip arthroplasty (THA) is effective in relieving patients’ symptoms and improving function. It is, however, associated with substantial risk of complications, pain and major functional limitation before patients can return to full function. In contrast, hip arthroscopy (HA) is less invasive and can postpone THA. However, there is no evidence regarding the delay in the need for THA that patients would find acceptable to undergoing HA. Knowing patients’ values and preferences (VP) on this expected delay is critical when making recommendations regarding the advisability of HA. Furthermore, little is known on the optimal amount of information regarding interventions and outcomes needed to present in order to optimally elicit patients’ VP. Methods and analysis We will perform a multinational, structured interview-based survey of preference in delay time for THA among patients with non-advanced OA who failed to respond to conservative therapy. We will combine these interviews with a randomised trial addressing the optimal amount of information regarding the interventions and outcomes required to elicit preferences. Eligible patients will be randomly assigned (1 : 1) to either a short or a long format of health scenarios of THA and HA. We will determine each patient's VP using a trade-off and anticipated regret exercises. Our primary outcomes for the combined surveys will be: (1) the minimal delay time in the need for THA surgery that patients would find acceptable to undertaking HA, (2) patients’ satisfaction with the amount of information provided in the health scenarios used to elicit their VPs. Ethics and dissemination The protocol has been approved by the Hamilton Integrated Research Ethics Board (HIREB13-506). We will disseminate our study findings through peer-reviewed publications and conference presentations, and make them available to guideline makers issuing recommendations addressing HA and THA. PMID:25326208

Biomarkers from distinct biological pathways improve early risk stratification in medical emergency patients: the multinational, prospective, observational TRIAGE study.

PubMed

Schuetz, Philipp; Hausfater, Pierre; Amin, Devendra; Amin, Adina; Haubitz, Sebastian; Faessler, Lukas; Kutz, Alexander; Conca, Antoinette; Reutlinger, Barbara; Canavaggio, Pauline; Sauvin, Gabrielle; Bernard, Maguy; Huber, Andreas; Mueller, Beat

2015-10-29

Early risk stratification in the emergency department (ED) is vital to reduce time to effective treatment in high-risk patients and to improve patient flow. Yet, there is a lack of investigations evaluating the incremental usefulness of multiple biomarkers measured upon admission from distinct biological pathways for predicting fatal outcome and high initial treatment urgency in unselected ED patients in a multicenter and multinational setting. We included consecutive, adult, medical patients seeking ED care into this observational, cohort study in Switzerland, France and the USA. We recorded initial clinical parameters and batch-measured prognostic biomarkers of inflammation (pro-adrenomedullin [ProADM]), stress (copeptin) and infection (procalcitonin). During a 30-day follow-up, 331 of 7132 (4.6 %) participants reached the primary endpoint of death within 30 days. In logistic regression models adjusted for conventional risk factors available at ED admission, all three biomarkers strongly predicted the risk of death (AUC 0.83, 0.78 and 0.75), ICU admission (AUC 0.67, 0.69 and 0.62) and high initial triage priority (0.67, 0.66 and 0.58). For the prediction of death, ProADM significantly improved regression models including (a) clinical information available at ED admission (AUC increase from 0.79 to 0.84), (b) full clinical information at ED discharge (AUC increase from 0.85 to 0.88), and (c) triage information (AUC increase from 0.67 to 0.83) (p <0.01 for each comparison). Similarly, ProADM also improved clinical models for prediction of ICU admission and high initial treatment urgency. Results were robust in regard to predefined patient subgroups by center, main diagnosis, presenting symptoms, age and gender. Combination of clinical information with results of blood biomarkers measured upon ED admission allows early and more adequate risk stratification in individual unselected medical ED patients. A randomized trial is needed to answer the question whether biomarker-guided initial patient triage reduces time to initial treatment of high-risk patients in the ED and thereby improves patient flow and clinical outcomes. ClinicalTrials.gov NCT01768494 . Registered January 9, 2013.

Understanding factors associated with the translation of cardiovascular research: a multinational case study approach.

PubMed

Wooding, Steven; Hanney, Stephen R; Pollitt, Alexandra; Grant, Jonathan; Buxton, Martin J

2014-04-21

Funders of health research increasingly seek to understand how best to allocate resources in order to achieve maximum value from their funding. We built an international consortium and developed a multinational case study approach to assess benefits arising from health research. We used that to facilitate analysis of factors in the production of research that might be associated with translating research findings into wider impacts, and the complexities involved. We built on the Payback Framework and expanded its application through conducting co-ordinated case studies on the payback from cardiovascular and stroke research in Australia, Canada and the United Kingdom. We selected a stratified random sample of projects from leading medical research funders. We devised a series of innovative steps to: minimize the effect of researcher bias; rate the level of impacts identified in the case studies; and interrogate case study narratives to identify factors that correlated with achieving high or low levels of impact. Twenty-nine detailed case studies produced many and diverse impacts. Over the 15 to 20 years examined, basic biomedical research has a greater impact than clinical research in terms of academic impacts such as knowledge production and research capacity building. Clinical research has greater levels of wider impact on health policies, practice, and generating health gains. There was no correlation between knowledge production and wider impacts. We identified various factors associated with high impact. Interaction between researchers and practitioners and the public is associated with achieving high academic impact and translation into wider impacts, as is basic research conducted with a clinical focus. Strategic thinking by clinical researchers, in terms of thinking through pathways by which research could potentially be translated into practice, is associated with high wider impact. Finally, we identified the complexity of factors behind research translation that can arise in a single case. We can systematically assess research impacts and use the findings to promote translation. Research funders can justify funding research of diverse types, but they should not assume academic impacts are proxies for wider impacts. They should encourage researchers to consider pathways towards impact and engage potential research users in research processes.

NARSTO PROGRAM SUPPORT

EPA Science Inventory

The NARSTO program is a multi-national, public/private partnership of over 70 organizations sponsoring and participating in ozone and particulate air quality research in North America. Coordinate communication and planning with the NARSTO membership for air quality research, sci...

Xerox' Canadian Research Facility: The Multinational and the "Offshore" Laboratory.

ERIC Educational Resources Information Center

Marchessault, R. H.; Myers, M. B.

1986-01-01

The history, logistics, and strategy behind the Xerox Corporation's Canadian research laboratory, a subsidiary firm located outside the United States for reasons of manpower, tax incentives, and quality of life, are described. (MSE)

78 FR 20893 - Legal Services Trade Mission to China, September 16-18, 2013

Federal Register 2010, 2011, 2012, 2013, 2014

2013-04-08

... services on United States laws for issues relating to taxation, employment, corporate finance, real estate... economy to a center of international business and finance, its need for sophisticated multinational legal...

NBAA business aviation fact book, 2003

DOT National Transportation Integrated Search

2003-01-01

Business aircraft are utilized by all types of people : and companies, from individuals who often fly rented, : single-engine, piston-powered airplanes, to sales : or management teams from the largest multinational : corporations, many of which own f...

Proposal for a definition of lifelong premature ejaculation based on epidemiological stopwatch data.

PubMed

Waldinger, Marcel D; Zwinderman, Aeilko H; Olivier, Berend; Schweitzer, Dave H

2005-07-01

Consensus on a definition of premature ejaculation has not yet been reached because of debates based on subjective authority opinions and nonstandardized assessment methods to measure ejaculation time and ejaculation control. To provide a definition for lifelong premature ejaculation that is based on epidemiological evidence including the neurobiological and psychological approach. We used the 0.5 and 2.5 percentiles as accepted standards of disease definition in a skewed distribution. We applied these percentiles in a stopwatch-determined intravaginal ejaculation latency time (IELT) distribution of 491 nonselected men from five different countries. The practical consequences of 0.5% and 2.5% cutoff points for disease definition were taken into consideration by reviewing current knowledge of feelings of control and satisfaction in relation to ejaculatory performance of the general male population. Literature arguments to be used in a proposed consensus on a definition of premature ejaculation. The stopwatch-determined IELT distribution is positively skewed. The 0.5 percentile equates to an IELT of 0.9 minute and the 2.5 percentile an IELT of 1.3 minutes. However, there are no available data in the literature on feelings of control or satisfaction in relation to ejaculatory latency time in the general male population. Random male cohort studies are needed to end all speculation on this subject. Exact stopwatch time assessment of IELT in a multinational study led us to propose that all men with an IELT of less than 1 minute (belonging to the 0.5 percentile) have "definite" premature ejaculation, while men with IELTs between 1 and 1.5 minutes (between 0.5 and 2.5 percentile) have "probable" premature ejaculation. Severity of premature ejaculation (nonsymptomatic, mild, moderate, severe) should be defined in terms of associated psychological problems. We define lifelong premature ejaculation as a neurobiological dysfunction with an unacceptable increase of risk to develop sexual and psychological problems anywhere in a lifetime. By defining premature ejaculation from an authority-defined disorder into a dysfunction based on epidemiological evidence it is possible to establish consensus based on epidemiological evidence. Additional epidemiological stopwatch studies are needed for a final decision of IELT values at both percentile cutoff points.

Points to consider: efficacy and safety evaluations in the clinical development of ultra-orphan drugs.

PubMed

Maeda, Kojiro; Kaneko, Masayuki; Narukawa, Mamoru; Arato, Teruyo

2017-08-23

The unmet medical needs of individuals with very rare diseases are high. The clinical trial designs and evaluation methods used for 'regular' drugs are not applicable in the clinical development of ultra-orphan drugs (<1000 patients) in many cases. In order to improve the clinical development of ultra-orphan drugs, we examined several points regarding the efficient evaluations of drug efficacy and safety that could be conducted even with very small sample sizes, based on the review reports of orphan drugs approved in Japan. The clinical data packages of 43 ultra-orphan drugs approved in Japan from January 2001 to December 2014 were investigated. Japanese clinical trial data were not included in the clinical data package for eight ultra-orphan drugs, and non-Japanese clinical trial data were included for six of these eight drug. Japanese supportive data that included retrospective studies, published literature, clinical research and Japanese survey results were clinical data package attachments in 22 of the 43 ultra-orphan drugs. Multinational trials were conducted for three ultra-orphan drugs. More than two randomized controlled trials (RCTs) were conducted for only 11 of the 43 ultra-orphan drugs. The smaller the number of patients, the greater the proportion of forced titration and optional titration trials were conducted. Extension trials were carried out for enzyme preparations and monoclonal antibodies with high ratio. Post-marketing surveillance of all patients was required in 36 of the 43 ultra-orphan drugs. For ultra-orphan drugs, clinical endpoints were used as the primary efficacy endpoint of the pivotal trial only for two drugs. The control groups in RCTs were classified as follows: placebo groups different dosage groups, and active controls groups. Sample sizes have been determined on the basis of feasibility for some ultra-orphan drugs. We provide "Draft Guidance on the Clinical Development of Ultra-Orphan Drugs" based on this research. The development of ultra-orphan drugs requires various arrangements regarding evidence collection, data sources and the clinical trial design. We expect that this draft guidance is useful for ultra-orphan drugs developments in future.

Framing Progress In Global Tobacco Control To Inform Action On Noncommunicable Diseases.

PubMed

Wipfli, Heather L; Samet, Jonathan

2015-09-01

Much has been learned about the tobacco epidemic, including its consequences, effective measures to control it, and the actors involved. This article identifies lessons learned that are applicable to the other principal external causes of noncommunicable diseases: alcohol abuse, poor nutrition, and physical inactivity. Among these lessons are the development of evidence-based strategies such as proven cessation methods, tax increases, and smoke-free policies; the role of multinational corporations in maintaining markets and undermining control measures; and the need for strategies that reach across the life course and that begin with individuals and extend to higher levels of societal organization. Differences are also clear. Tobacco products are relatively homogeneous and have no direct benefit to consumers, whereas food and alcohol consumed in moderation are not inherently dangerous. Some tobacco-related diseases have the singular predominant cause of smoking, while many noncommunicable diseases have multiple interlocking causes such as poor diet, excess alcohol consumption, insufficient physical activity, and smoking, along with genetics. Thus, the tobacco control model of comprehensive multilevel strategies is applicable to the control of noncommunicable diseases, but the focus must be on multiple risk factors. Project HOPE—The People-to-People Health Foundation, Inc.

EURO-CARES as Roadmap for a European Sample Curation Facility

NASA Astrophysics Data System (ADS)

Brucato, J. R.; Russell, S.; Smith, C.; Hutzler, A.; Meneghin, A.; Aléon, J.; Bennett, A.; Berthoud, L.; Bridges, J.; Debaille, V.; Ferrière, L.; Folco, L.; Foucher, F.; Franchi, I.; Gounelle, M.; Grady, M.; Leuko, S.; Longobardo, A.; Palomba, E.; Pottage, T.; Rettberg, P.; Vrublevskis, J.; Westall, F.; Zipfel, J.; Euro-Cares Team

2018-04-01

EURO-CARES is a three-year multinational project funded under the European Commission Horizon2020 research program to develop a roadmap for a European Extraterrestrial Sample Curation Facility for samples returned from solar system missions.

The GLOBE Visualization Project: Using WWW in the Classroom.

ERIC Educational Resources Information Center

de La Beaujardiere, J-F; And Others

1997-01-01

Describes a World Wide Web-based, user-friendly, language-independent graphical user interface providing access to visualizations created for GLOBE (Global Learning and Observations to Benefit the Environment), a multinational program of education and science. (DDR)

Multinational Experiment 7: Catalog of Products

DTIC Science & Technology

2013-07-08

Organization (NATO) Allied Command Transformation (ACT), Netherlands (Observer), Norway, Poland , the Republic of Korea, Spain, Sweden, Switzerland, Turkey...Awareness. Noteworthy among the products, the Cross-Cultural Awareness concept, the anthropological study of Afghanistan, and a suite of training

Cohesion in Multinational Military Units

DTIC Science & Technology

2010-12-10

Assertiveness for Hofstede’s Masculinity dimension and added three dimensions: Humanistic , Performance, and Future Orientation. GLOBE researchers...values. It addresses the most profound existential issues of human life; e.g. freedom and inevitability, fear and faith, security and insecurity, right

Impact on Employee Productivity From Presenteeism and Absenteeism: Evidence From a Multinational Firm in Sri Lanka.

PubMed

Fernando, Mario; Caputi, Peter; Ashbury, Fred

2017-07-01

This study examines the effects of 13 psychological and physical health conditions on work productivity. One hundred fifty-two staff at the headquarters of a Sri Lankan multinational firm completed a questionnaire asking whether they experienced 13 health conditions common in workplaces, and about their related absenteeism and presenteeism. Most respondents (85.5%) reported absenteeism, presenteeism, or both. Among those reporting a health condition, 57.6% reported losing days due to absenteeism, and 69.5% reported losing additional days to presenteeism. Among those caring for a sick adult or child, 57.3% reported losing days due to absenteeism, and 36.5% reported losing additional days due to presenteeism. Overall productivity loss was 10.43 days each year, 3.95% of employee capacity, equating to about Sri Lanka Rupees 8 million (US$54,421) for all headquarters employees. The health conditions' effects on productivity significantly increased employee costs.

China: current trends in pharmaceutical drug discovery.

PubMed

Luo, Ying

2008-04-01

Pharmaceutical discovery and development is expensive and highly risky, even for multinational corporations. As a developing country with limited financial resources, China has been seeking the most cost-effective means to reach the same level of innovation and productivity as Western countries in the pharmaceutical industry sector. After more than 50 years of building up talent and experience, the time for China to become a powerhouse in pharmaceutical innovation is finally approaching. Returnee scientists to China are one of the reasons for the wave of new discovery and commercialization occurring within the country. The consolidation of local Chinese pharmaceutical companies and foreign investment is also providing an agreeable environment for the evolution of a new generation of biotechnology. The opportunity for pharmaceutical innovation is also being expedited by the entry of multinational companies into the Chinese pharmaceutical market, and by the outsourcing of research from these companies to China.

The globalization of the arms industry: The next proliferation challenge

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

Bitzinger, R.A.

1994-12-31

The globalization of the arms industry entails a significant shift away from traditional, single-country patterns of weapons production toward internationalization of the development, production, and marketing of arms. While wholly indigenous armaments production may be on the decline, multinational arms production - through collaboration on individual weapon systems and increasingly via interfirm linkages across the international arms industry - appears actually to be expanding. In several instances, in fact, multinational armaments production is increasingly supplementing or even supplanting indigenous or autonomous weapons production or arms imports. The emergence of an increasingly transnational defense technology and industrial base is fundamentally affectingmore » the shape and content of much of the global arms trade. This changing defense market, in turn, will have a profound impact on a number of national security issues concerning the Western industrialized nations. 3 figs., 2 tabs.« less

Multilevel models for estimating incremental net benefits in multinational studies.

PubMed

Grieve, Richard; Nixon, Richard; Thompson, Simon G; Cairns, John

2007-08-01

Multilevel models (MLMs) have been recommended for estimating incremental net benefits (INBs) in multicentre cost-effectiveness analysis (CEA). However, these models have assumed that the INBs are exchangeable and that there is a common variance across all centres. This paper examines the plausibility of these assumptions by comparing various MLMs for estimating the mean INB in a multinational CEA. The results showed that the MLMs that assumed the INBs were exchangeable and had a common variance led to incorrect inferences. The MLMs that included covariates to allow for systematic differences across the centres, and estimated different variances in each centre, made more plausible assumptions, fitted the data better and led to more appropriate inferences. We conclude that the validity of assumptions underlying MLMs used in CEA need to be critically evaluated before reliable conclusions can be drawn. Copyright 2006 John Wiley & Sons, Ltd.

Workplace violence investigations and activation of the threat management teams in a multinational corporation.

PubMed

Peek-Asa, Corinne; Casteel, Carri; Rugala, Eugene; Romano, Steve; Ramirez, Marizen

2013-11-01

We examined threat management investigations conducted by a large multinational company. The company provided a database, removing any identifiers, of investigations by the corporate Threat Management Teams in 2009 and 2010. Rates were calculated using worker population data. During the 2-year study period, the company investigated threat management cases at a rate of 13.9 per 10,000 employees per year. Cases that activated a Threat Management Team were more likely to lead to corrective action (odds ratio = 2.0; 95% confidence interval = 1.08 to 3.87) and referral to the Employee Assistance Program (odds ratio = 4.8; 95% confidence interval = 3.00 to 7.77), but were not related to likelihood of termination. When the multidisciplinary teams were involved, cases were more likely to result in some type of action but were not more likely to lead to termination.

Medical support of the Sinai Multinational Force and Observers: an update, 2001.

PubMed

Rowe, John R

2003-02-01

The Multinational Force and Observers is an 11-nation coalition force with the mission of peacekeeping in the Sinai. It commenced operations in 1982 and continues today after two decades of successful enforcement of the 1979 Egyptian-Israeli Treaty of Peace. The fielding of a medical support team for this mission was the first effort of its kind for the U.S. Army Medical Department, resulting in a uniquely organized medical unit. A U.S. Army physician heads the medical team, which includes nine other physicians from six different countries. The team provides health care for the 2,500-person coalition in the remote Sinai desert. This writing compares earlier medical support with that of August 2000 through July 2001 and describes medical conditions and problems encountered during the 12-month tour of duty. This article updates two previous articles on the subject published in Military Medicine in 1983 and 1991.

Relationship Between Patients' Perceptions of Care Quality and Health Care Errors in 11 Countries: A Secondary Data Analysis.

PubMed

Hincapie, Ana L; Slack, Marion; Malone, Daniel C; MacKinnon, Neil J; Warholak, Terri L

2016-01-01

Patients may be the most reliable reporters of some aspects of the health care process; their perspectives should be considered when pursuing changes to improve patient safety. The authors evaluated the association between patients' perceived health care quality and self-reported medical, medication, and laboratory errors in a multinational sample. The analysis was conducted using the 2010 Commonwealth Fund International Health Policy Survey, a multinational consumer survey conducted in 11 countries. Quality of care was measured by a multifaceted construct developed using Rasch techniques. After adjusting for potentially important confounding variables, an increase in respondents' perceptions of care coordination decreased the odds of self-reporting medical errors, medication errors, and laboratory errors (P < .001). As health care stakeholders continue to search for initiatives that improve care experiences and outcomes, this study's results emphasize the importance of guaranteeing integrated care.

Real-world geographic variations in the use of cardiac implantable electronic devices - The PANORAMA 2 observational cohort study.

PubMed

Bastian, Dirk; Ebrahim, Iftikhar O; Chen, Ju-Yi; Chen, Mien-Cheng; Huang, Dejia; Huang, Jin-Long; Kuznetsov, Vadim A; Maus, Bärbel; Naik, Ajay M; Verhees, Koen J P; Fagih, Ahmed R Al

2018-06-13

Currently, several geographies around the world remain underrepresented in medical device trials. The PANORAMA 2 study was designed to assess contemporary region-specific differences in clinical practice patterns of patients with cardiac implantable electronic devices (CIEDs). In this prospective, multicenter, observational, multi-national study, baseline and implant data of 4,706 patients receiving Medtronic CIEDs (either de novo device implants, replacements, or upgrades) were analyzed, consisting of: 54% implantable pulse generators (IPGs), 20.3% implantable cardiac defibrillators (ICDs), 15% cardiac resynchronization therapy defibrillators (CRT-Ds), 5.1% cardiac resynchronization therapy pacemakers (CRT-Ps), from 117 hospitals in 23 countries across 4 geographical regions between 2012 and 2016. For all device types, in all regions, there were less females than males enrolled, and women were less likely to have ischemic cardiomyopathy. Implant procedure duration differed significantly across the geographies for all device types. Subjects from emerging countries, women and older patients were less likely to receive a magnetic resonance imaging (MRI)-compatible device. Defibrillation testing differed significantly between the regions. European patients had the highest rates of atrial fibrillation (AF), and the lowest number of implanted single-chamber IPGs. Evaluation of stroke history suggested that the general embolic risk is more strongly associated with stroke than AF. We provide comprehensive descriptive data on patients receiving Medtronic CIEDs from several geographies, some of which are understudied in randomized controlled trials (RCTs). We found significant variations in patient characteristics. Several medical decisions appear to be affected by socioeconomic factors. Long-term follow-up data will help evaluate if these variations require adjustments to outcome expectations. This article is protected by copyright. All rights reserved. This article is protected by copyright. All rights reserved.

Development and Validation of an Interactive Internet Platform for Older People: The Healthy Ageing Through Internet Counselling in the Elderly Study.

PubMed

Jongstra, Susan; Beishuizen, Cathrien; Andrieu, Sandrine; Barbera, Mariagnese; van Dorp, Matthijs; van de Groep, Bram; Guillemont, Juliette; Mangialasche, Francesca; van Middelaar, Tessa; Moll van Charante, Eric; Soininen, Hilkka; Kivipelto, Miia; Richard, Edo

2017-02-01

A myriad of Web-based applications on self-management have been developed, but few focus on older people. In the face of global aging, older people form an important target population for cardiovascular prevention. This article describes the full development of an interactive Internet platform for older people, which was designed for the Healthy Ageing Through Internet Counselling in the Elderly (HATICE) study. We provide recommendations to design senior-friendly Web-based applications for a new approach to multicomponent cardiovascular prevention. The development of the platform followed five phases: (1) conceptual framework; (2) platform concept and functional design; (3) platform building (software and content); (4) testing and pilot study; and (5) final product. We performed a meta-analysis, reviewed guidelines for cardiovascular diseases, and consulted end users, experts, and software developers to create the platform concept and content. The software was built in iterative cycles. In the pilot study, 41 people aged ≥65 years used the platform for 8 weeks. Participants used the interactive features of the platform and appreciated the coach support. During all phases adjustments were made to incorporate all improvements from the previous phases. The final platform is a personal, secured, and interactive platform supported by a coach. When carefully designed, an interactive Internet platform is acceptable and feasible for use by older people with basic computer skills. To improve acceptability by older people, we recommend involving the end users in the process of development, to personalize the platform and to combine the application with human support. The interactive HATICE platform will be tested for efficacy in a multinational randomized controlled trial (ISRCTN48151589).

Bronchoscopic Thermal Vapor Ablation: Best Practice Recommendations from an Expert Panel on Endoscopic Lung Volume Reduction.

PubMed

Gompelmann, Daniela; Shah, Pallav L; Valipour, Arschang; Herth, Felix J F

2018-06-12

Bronchoscopic thermal vapor ablation (BTVA) represents one of the endoscopic lung volume reduction (ELVR) techniques that aims at hyperinflation reduction in patients with advanced emphysema to improve respiratory mechanics. By targeted segmental vapor ablation, an inflammatory response leads to tissue and volume reduction of the most diseased emphysematous segments. So far, BTVA has been demonstrated in several single-arm trials and 1 multinational randomized controlled trial to improve lung function, exercise capacity, and quality of life in patients with upper lobe-predominant emphysema irrespective of the collateral ventilation. In this review, we emphasize the practical aspects of this ELVR method. Patients with upper lobe-predominant emphysema, forced expiratory volume in 1 second (FEV1) between 20 and 45% of predicted, residual volume (RV) > 175% of predicted, and carbon monoxide diffusing capacity (DLCO) ≥20% of predicted can be considered for BTVA treatment. Prior to the procedure, a special software assists in identifying the target segments with the highest emphysema index, volume and the highest heterogeneity index to the untreated ipsilateral lung lobes. The procedure may be performed under deep sedation or preferably under general anesthesia. After positioning of the BTVA catheter and occlusion of the target segment by the occlusion balloon, heated water vapor is delivered in a predetermined specified time according to the vapor dose. After the procedure, patients should be strictly monitored to proactively detect symptoms of localized inflammatory reaction that may temporarily worsen the clinical status of the patient and to detect complications. As the data are still very limited, BTVA should be performed within clinical trials or comprehensive registries where the product is commercially available. © 2018 S. Karger AG, Basel.

"A phony way to show sincerity, as we all well know": tobacco industry lobbying against tobacco control in Hong Kong

PubMed Central

Knight, J; Chapman, S

2004-01-01

Objective: To examine the tobacco industry's efforts to influence public policy and block the legislative process on tobacco control in Hong Kong, 1973 to 1997. Method: Systematic review of relevant tobacco industry documents made public via the Master Settlement Agreement. Results: The tobacco industry in Hong Kong has sought to manipulate the policymaking process and delay the introduction of tobacco control legislation in Hong Kong from at least 1973. The industry ensured that each of the government's initial meagre steps toward tobacco control were delayed and thwarted by drawn out "cooperation" followed by voluntary concessions on issues the industry regarded as minor. By the 1980s the government had became increasingly active in tobacco control and introduced a number of initiatives, resulting in some of the tightest legislative restrictions on smoking in Asia. The tobacco industry was successful in thwarting only one of these initiatives. Conclusions: Throughout the 1980s and 1990s two factors played a significant role in hindering the tobacco industry from successfully blocking policy initiatives: a growing political imperative, and an active and sophisticated tobacco control movement. Political will to promote public health and a strong tobacco control advocacy presence can enable governments to resist the enormous pressure exerted upon them by multinational tobacco companies. PMID:15564215

Quantifying the impact of selection bias caused by nonparticipation in a case-control study of mobile phone use.

PubMed

Vrijheid, Martine; Richardson, Lesley; Armstrong, Bruce K; Auvinen, Anssi; Berg, Gabriele; Carroll, Matthew; Chetrit, Angela; Deltour, Isabelle; Feychting, Maria; Giles, Graham G; Hours, Martine; Iavarone, Ivano; Lagorio, Susanna; Lönn, Stefan; McBride, Mary; Parent, Marie-Elise; Sadetzki, Siegal; Salminen, Tina; Sanchez, Marie; Schlehofer, Birgitte; Schüz, Joachim; Siemiatycki, Jack; Tynes, Tore; Woodward, Alistair; Yamaguchi, Naohito; Cardis, Elisabeth

2009-01-01

To quantitatively assess the impact of selection bias caused by nonparticipation in a multinational case-control study of mobile phone use and brain tumor. Non-response questionnaires (NRQ) were completed by a sub-set of nonparticipants. Selection bias factors were calculated based on the prevalence of mobile phone use reported by nonparticipants with NRQ data, and on scenarios of hypothetical exposure prevalence for other nonparticipants. Regular mobile phone use was reported less frequently by controls and cases who completed the NRQ (controls, 56%; cases, 50%) than by those who completed the full interview (controls, 69%; cases, 66%). This relationship was consistent across study centers, sex, and age groups. Lower education and more recent start of mobile phone use were associated with refusal to participate. Bias factors varied between 0.87 and 0.92 in the most plausible scenarios. Refusal to participate in brain tumor case-control studies seems to be related to less prevalent use of mobile phones, and this could result in a downward bias of around 10% in odds ratios for regular mobile phone use. The use of simple selection bias estimation methods in case-control studies can give important insights into the extent of any bias, even when nonparticipant information is incomplete.

The great transition.

PubMed

Lieberthal, Kenneth; Lieberthal, Geoffrey

2003-10-01

As China's economy grows and opens further, the opportunity it presents to multinationals is changing. Foreign companies are moving to country development and new strategic choices. Now, foreign firms can actually go after the Chinese domestic market, and it's worth going after. Improvements in China's infrastructure, workforce, and regulatory environment are making it possible for companies to lower their costs to reap new competitive advantages. Multifaceted and often-shifting risks accompany this shifting opportunity. The reforms required for admission into the WTO will be politically difficult for China to implement, and its progress will be slowed by the scarcity of resources for the country's shaky banking system, the inadequacy of the social safety net, environmental problems, and local governments' cash shortage. China's breathtaking 9% average annual GDP growth rests on an unsteady foundation of overcapitalized state-owned enterprises, which have oversupplied many markets, and fiercely protectionist regional government officials pursuing growth-at-almost-all-costs policies. Frequent changes in regulations, bureaucracies, and reporting relationships will continue to make planning difficult, and, as the SARS epidemic demonstrated, there is always the potential for serious disruptions. But for at least the next ten years, multinationals should be the biggest winners in China. To reap the benefits, a multinational must properly nest its effort into its overall organization, show "one face to China" at the national level but also tailor local strategies, be wary of joint ventures, and mitigate risk, in particular the theft of intellectual property. China is a major opportunity for companies that forthrightly face its complexities. It will remain largely inscrutable--and unprofitable--for the rest.

Clinical trial allocation in multinational pharmaceutical companies - a qualitative study on influential factors.

PubMed

Dombernowsky, Tilde; Haedersdal, Merete; Lassen, Ulrik; Thomsen, Simon F

2017-06-01

Clinical trial allocation in multinational pharmaceutical companies includes country selection and site selection. With emphasis on site selection, the overall aim of this study was to examine which factors pharmaceutical companies value most when allocating clinical trials. The specific aims were (1) to identify key decision makers during country and site selection, respectively, (2) to evaluate by which parameters subsidiaries are primarily assessed by headquarters with regard to conducting clinical trials, and (3) to evaluate which site-related qualities companies value most when selecting trial sites. Eleven semistructured interviews were conducted among employees engaged in trial allocation at 11 pharmaceutical companies. The interviews were analyzed by deductive content analysis, which included coding of data to a categorization matrix containing categories of site-related qualities. The results suggest that headquarters and regional departments are key decision makers during country selection, whereas subsidiaries decide on site selection. Study participants argued that headquarters primarily value timely patient recruitment and quality of data when assessing subsidiaries. The site-related qualities most commonly emphasized during interviews were study population availability, timely patient recruitment, resources at the site, and site personnel's interest and commitment. Costs of running the trials were described as less important. Site personnel experience in conducting trials was described as valuable but not imperative. In conclusion, multinational pharmaceutical companies consider recruitment-related factors as crucial when allocating clinical trials. Quality of data and site personnel's interest and commitment are also essential, whereas costs seem less important. While valued, site personnel experience in conducting clinical trials is not imperative.

Multinational trials-recommendations on the translations required, approaches to using the same language in different countries, and the approaches to support pooling the data: the ISPOR Patient-Reported Outcomes Translation and Linguistic Validation Good Research Practices Task Force report.

PubMed

Wild, Diane; Eremenco, Sonya; Mear, Isabelle; Martin, Mona; Houchin, Caroline; Gawlicki, Mary; Hareendran, Asha; Wiklund, Ingela; Chong, Lee Yee; von Maltzahn, Robyn; Cohen, Lawrence; Molsen, Elizabeth

2009-06-01

With the internationalization of clinical trial programs, there is an increased need to translate and culturally adapt patient-reported outcome (PRO) measures. Although guidelines for good practices in translation and linguistic validation are available, the ISPOR Patient-Reported Outcomes Translation and Linguistic Validation Task Force identified a number of areas where they felt that further discussion around methods and best practices would be beneficial. The areas identified by the team were as follows: 1) the selection of the languages required for multinational trials; 2) the approaches suggested when the same language is required across two or more countries; and 3) the assessment of measurement equivalence to support the aggregation of data from different countries. The task force addressed these three areas, reviewed the available literature, and had multiple discussions to develop this report. Decision aid tools have also been developed and presented for the selection of languages and the approaches suggested for the use of the same language in different countries. It is hoped that this report and the decision tools proposed will assist those involved with multinational trials to 1) decide on the translations required for each country; 2) choose the approach to use when the same language is spoken in more than one country; and 3) choose methods to gather evidence to support the pooling of data collected using different language versions of the same tool.

Multinational evidence-based recommendations for the diagnosis and management of gout: integrating systematic literature review and expert opinion of a broad panel of rheumatologists in the 3e initiative

PubMed Central

Sivera, Francisca; Andrés, Mariano; Carmona, Loreto; Kydd, Alison S R; Moi, John; Seth, Rakhi; Sriranganathan, Melonie; van Durme, Caroline; van Echteld, Irene; Vinik, Ophir; Wechalekar, Mihir D; Aletaha, Daniel; Bombardier, Claire; Buchbinder, Rachelle; Edwards, Christopher J; Landewé, Robert B; Bijlsma, Johannes W; Branco, Jaime C; Burgos-Vargas, Rubén; Catrina, Anca I; Elewaut, Dirk; Ferrari, Antonio J L; Kiely, Patrick; Leeb, Burkhard F; Montecucco, Carlomaurizio; Müller-Ladner, Ulf; Østergaard, Mikkel; Zochling, Jane; Falzon, Louise; van der Heijde, Désirée M

2014-01-01

We aimed to develop evidence-based multinational recommendations for the diagnosis and management of gout. Using a formal voting process, a panel of 78 international rheumatologists developed 10 key clinical questions pertinent to the diagnosis and management of gout. Each question was investigated with a systematic literature review. Medline, Embase, Cochrane CENTRAL and abstracts from 2010–2011 European League Against Rheumatism and American College of Rheumatology meetings were searched in each review. Relevant studies were independently reviewed by two individuals for data extraction and synthesis and risk of bias assessment. Using this evidence, rheumatologists from 14 countries (Europe, South America and Australasia) developed national recommendations. After rounds of discussion and voting, multinational recommendations were formulated. Each recommendation was graded according to the level of evidence. Agreement and potential impact on clinical practice were assessed. Combining evidence and clinical expertise, 10 recommendations were produced. One recommendation referred to the diagnosis of gout, two referred to cardiovascular and renal comorbidities, six focused on different aspects of the management of gout (including drug treatment and monitoring), and the last recommendation referred to the management of asymptomatic hyperuricaemia. The level of agreement with the recommendations ranged from 8.1 to 9.2 (mean 8.7) on a 1–10 scale, with 10 representing full agreement. Ten recommendations on the diagnosis and management of gout were established. They are evidence-based and supported by a large panel of rheumatologists from 14 countries, enhancing their utility in clinical practice. PMID:23868909

Multinational evidence-based recommendations on how to investigate and follow-up undifferentiated peripheral inflammatory arthritis: integrating systematic literature research and expert opinion of a broad international panel of rheumatologists in the 3E Initiative.

PubMed

Machado, P; Castrejon, I; Katchamart, W; Koevoets, R; Kuriya, B; Schoels, M; Silva-Fernández, L; Thevissen, K; Vercoutere, W; Villeneuve, E; Aletaha, D; Carmona, L; Landewé, R; van der Heijde, D; Bijlsma, J W J; Bykerk, V; Canhão, H; Catrina, A I; Durez, P; Edwards, C J; Mjaavatten, M D; Leeb, B F; Losada, B; Martín-Mola, E M; Martinez-Osuna, P; Montecucco, C; Müller-Ladner, U; Østergaard, M; Sheane, B; Xavier, R M; Zochling, J; Bombardier, C

2011-01-01

To develop evidence-based recommendations on how to investigate and follow-up undifferentiated peripheral inflammatory arthritis (UPIA). 697 rheumatologists from 17 countries participated in the 3E (Evidence, Expertise, Exchange) Initiative of 2008-9 consisting of three separate rounds of discussions and modified Delphi votes. In the first round 10 clinical questions were selected. A bibliographic team systematically searched Medline, Embase, the Cochrane Library and ACR/EULAR 2007-2008 meeting abstracts. Relevant articles were reviewed for quality assessment, data extraction and synthesis. In the second round each country elaborated a set of national recommendations. Finally, multinational recommendations were formulated and agreement among the participants and the potential impact on their clinical practice was assessed. A total of 39,756 references were identified, of which 250 were systematically reviewed. Ten multinational key recommendations about the investigation and follow-up of UPIA were formulated. One recommendation addressed differential diagnosis and investigations prior to establishing the operational diagnosis of UPIA, seven recommendations related to the diagnostic and prognostic value of clinical and laboratory assessments in established UPIA (history and physical examination, acute phase reactants, autoantibodies, radiographs, MRI and ultrasound, genetic markers and synovial biopsy), one recommendation highlighted predictors of persistence (chronicity) and the final recommendation addressed monitoring of clinical disease activity in UPIA. Ten recommendations on how to investigate and follow-up UPIA in the clinical setting were developed. They are evidence-based and supported by a large panel of rheumatologists, thus enhancing their validity and practical use.

Routine versus aggressive upstream rhythm control for prevention of early atrial fibrillation in heart failure: background, aims and design of the RACE 3 study.

PubMed

Alings, M; Smit, M D; Moes, M L; Crijns, H J G M; Tijssen, J G P; Brügemann, J; Hillege, H L; Lane, D A; Lip, G Y H; Smeets, J R L M; Tieleman, R G; Tukkie, R; Willems, F F; Vermond, R A; Van Veldhuisen, D J; Van Gelder, I C

2013-07-01

Rhythm control for atrial fibrillation (AF) is cumbersome because of its progressive nature caused by structural remodelling. Upstream therapy refers to therapeutic interventions aiming to modify the atrial substrate, leading to prevention of AF. The Routine versus Aggressive upstream rhythm Control for prevention of Early AF in heart failure (RACE 3) study hypothesises that aggressive upstream rhythm control increases persistence of sinus rhythm compared with conventional rhythm control in patients with early AF and mild-to-moderate early systolic or diastolic heart failure undergoing electrical cardioversion. RACE 3 is a prospective, randomised, open, multinational, multicenter trial. Upstream rhythm control consists of angiotensin converting enzyme inhibitors and/or angiotensin receptor blockers, mineralocorticoid receptor antagonists, statins, cardiac rehabilitation therapy, and intensive counselling on dietary restrictions, exercise maintenance, and drug adherence. Conventional rhythm control consists of routine rhythm control therapy without cardiac rehabilitation therapy and intensive counselling. In both arms, every effort is made to keep patients in the rhythm control strategy, and ion channel antiarrhythmic drugs or pulmonary vein ablation may be instituted if AF relapses. Total inclusion will be 250 patients. If upstream therapy proves to be effective in improving maintenance of sinus rhythm, it could become a new approach to rhythm control supporting conventional pharmacological and non-pharmacological rhythm control.

Seven Programs for Seven Countries

ERIC Educational Resources Information Center

Otte, Max R.

1975-01-01

Programs from abroad represented at the January, 1975 Multinational Workshop on Adult Education (Washington, D. C.) included: Rural Reconstruction Movement (Philippines); Nonformal Education for Rural Women (Andhra Pradesh, India); Accion Cultural Popular (Colombia); Village Polytechnic Centers (Kenya); CONCORDE (Honduras); National Adult…

10 CFR 1050.103 - Definitions.

Code of Federal Regulations, 2010 CFR

2010-01-01

... government means: (1) Any unit of foreign governmental authority, including any foreign national, State, local, or municipal government; (2) Any international or multinational organization whose membership is... of an organization performing services under such section, any individual involved in the performance...

Adult Education through World Collaboration.

ERIC Educational Resources Information Center

Cassara, Beverly Benner, Ed.

This book contains the following papers about development/delivery of adult education through the efforts of multinational and bilateral government donors and the International Council for Adult Education (ICAE): "Preface" (Beverly Benner Cassara); "Introduction: Adult Education and Democracy" (Francisco Vio Grossi);…

Global Public Leadership in a Technological Era

ERIC Educational Resources Information Center

Masciulli, Joseph

2011-01-01

Good (ethical and effective) global public leadership--by national politicians, intergovernmental and nongovernmental international organizational leaders, multinational corporate leaders, and technoscientists--will make a significant positive difference in our global system's capacity to solve contemporary and futuristic global problems. High…

IAI Capacity Building Activities in the Americas: Fostering Multinational and Multidisciplinary Research

NASA Astrophysics Data System (ADS)

Ohira, M. S.

2007-05-01

The IAI's Training and Education (T&E) activities are designed to encourage capacity building in the Americas and are developed within and in parallel with the IAI research programs in global environmental change (GEC). The IAI has various training priorities: (1) support for graduate students in the form of fellowships through research programs; (2) development of IAI Training Institutes in Interdisciplinary Sciences and Science-Policy Fora; and (3) support for technical workshops, scientific meetings, and seminars. It becomes increasingly evident that institutions such as IAI must provide training and support to policy and decision makers who deal with environmental issues. The IAI Training Institutes emphasize an exchange of information about the various scientific languages, needs, and methodologies of disciplines that study GEC. Particular attention is given to socio-economic impacts and ways in which nations can gain a better understanding of the complex mechanisms, degrees of change, causes, and consequences - and therefore, plan sound public and private policies to minimize problems and maximize opportunities. The IAI has also implemented a Training Institute Seed Grant (TISG) Program as an assessment activity of the Training Institutes to further encourage network building and multinational and multidisciplinary collaboration among its 19 member countries in the Americas. By fostering the development of such new multidisciplinary, multinational teams, the IAI ensures a future generation of professionals who will be engaged in IAI research programs and networks and will lead the integrated science programs in the next decades. Furthermore, IAI has organized Science-Policy Fora, which focus on the science- policy interface and ways to incorporate scientific information into policy and decision-making processes. Participants discussed what scientific information is available, what aspects need to be better understood, translation of scientific information for the nonscientific community, potential uses of technical information, and policy issues that should be incorporated into the scientific community's agenda. Participants are individuals from governmental agencies, national and international organizations, nongovernmental organizations (NGO), universities, and private companies. Various other T&E-based initiatives that contribute to the building of scientific capacity in the Americas are supported by the IAI. Workshops, seminars, conferences, and other venues encourage the exchange of information and data providing scientists and professionals in global change related fields many opportunities to interact and benefit from multinational, multidisciplinary collaborations.

Lanreotide in metastatic enteropancreatic neuroendocrine tumors.

PubMed

Caplin, Martyn E; Pavel, Marianne; Ćwikła, Jarosław B; Phan, Alexandria T; Raderer, Markus; Sedláčková, Eva; Cadiot, Guillaume; Wolin, Edward M; Capdevila, Jaume; Wall, Lucy; Rindi, Guido; Langley, Alison; Martinez, Séverine; Blumberg, Joëlle; Ruszniewski, Philippe

2014-07-17

Somatostatin analogues are commonly used to treat symptoms associated with hormone hypersecretion in neuroendocrine tumors; however, data on their antitumor effects are limited. We conducted a randomized, double-blind, placebo-controlled, multinational study of the somatostatin analogue lanreotide in patients with advanced, well-differentiated or moderately differentiated, nonfunctioning, somatostatin receptor-positive neuroendocrine tumors of grade 1 or 2 (a tumor proliferation index [on staining for the Ki-67 antigen] of <10%) and documented disease-progression status. The tumors originated in the pancreas, midgut, or hindgut or were of unknown origin. Patients were randomly assigned to receive an extended-release aqueous-gel formulation of lanreotide (Autogel [known in the United States as Depot], Ipsen) at a dose of 120 mg (101 patients) or placebo (103 patients) once every 28 days for 96 weeks. The primary end point was progression-free survival, defined as the time to disease progression (according to the Response Evaluation Criteria in Solid Tumors, version 1.0) or death. Secondary end points included overall survival, quality of life (assessed with the European Organization for Research and Treatment of Cancer questionnaires QLQ-C30 and QLQ-GI.NET21), and safety. Most patients (96%) had no tumor progression in the 3 to 6 months before randomization, and 33% had hepatic tumor volumes greater than 25%. Lanreotide, as compared with placebo, was associated with significantly prolonged progression-free survival (median not reached vs. median of 18.0 months, P<0.001 by the stratified log-rank test; hazard ratio for progression or death, 0.47; 95% confidence interval [CI], 0.30 to 0.73). The estimated rates of progression-free survival at 24 months were 65.1% (95% CI, 54.0 to 74.1) in the lanreotide group and 33.0% (95% CI, 23.0 to 43.3) in the placebo group. The therapeutic effect in predefined subgroups was generally consistent with that in the overall population, with the exception of small subgroups in which confidence intervals were wide. There were no significant between-group differences in quality of life or overall survival. The most common treatment-related adverse event was diarrhea (in 26% of the patients in the lanreotide group and 9% of those in the placebo group). Lanreotide was associated with significantly prolonged progression-free survival among patients with metastatic enteropancreatic neuroendocrine tumors of grade 1 or 2 (Ki-67 <10%). (Funded by Ipsen; CLARINET ClinicalTrials.gov number, NCT00353496; EudraCT 2005-004904-35.).

Marketing alcohol to young people: implications for industry regulation and research policy.

PubMed

Jackson, M C; Hastings, G; Wheeler, C; Eadie, D; Mackintosh, A M

2000-12-01

This paper focuses on the marketing of alcohol to young people in the United Kingdom, but the lessons that emerge have international significance. Alcohol is a global enterprise and recent consolidation means that it is controlled by a decreasing number of expanding multi-nationals. Alcohol companies are able to allocate significant resources to researching consumer preferences, developing new products and promoting them on an international level. Recent years have seen a growth in the value that youth culture attaches to brand labels and symbols and a move away from the healthy-living ethos. The alcohol industry's response to these trends has been to design alcoholic beverages that appeal to young people, using well-informed and precisely targeted marketing strategies. This has led to growing concerns about the implications for public health and a demand for tighter controls to regulate alcohol marketing practices. In the United Kingdom, controls on alcohol are piecemeal and reactive and the current system of voluntary regulation appears ineffective. This paper argues for more research to establish current industry practice and inform the development of a comprehensive regulatory structure and system of monitoring.

Long-term outcome and prognostic factors of juvenile dermatomyositis: a multinational, multicenter study of 490 patients.

PubMed

Ravelli, Angelo; Trail, Lucia; Ferrari, Cristina; Ruperto, Nicolino; Pistorio, Angela; Pilkington, Clarissa; Maillard, Susan; Oliveira, Sheila K; Sztajnbok, Flavio; Cuttica, Ruben; Beltramelli, Matilde; Corona, Fabrizia; Katsicas, Maria Martha; Russo, Ricardo; Ferriani, Virginia; Burgos-Vargas, Ruben; Magni-Manzoni, Silvia; Solis-Valleoj, Eunice; Bandeira, Marcia; Zulian, Francesco; Baca, Vicente; Cortis, Elisabetta; Falcini, Fernanda; Alessio, Maria; Alpigiani, Maria Giannina; Gerloni, Valeria; Saad-Magalhaes, Claudia; Podda, Rosanna; Silva, Clovis A; Lepore, Loredana; Felici, Enrico; Rossi, Federica; Sala, Elena; Martini, Alberto

2010-01-15

To investigate the long-term outcome and prognostic factors of juvenile dermatomyositis (DM) through a multinational, multicenter study. Patients consisted of inception cohorts seen between 1980 and 2004 in 27 centers in Europe and Latin America. Predictor variables were sex, continent, ethnicity, onset year, onset age, onset type, onset manifestations, course type, disease duration, and active disease duration. Outcomes were muscle strength/endurance, continued disease activity, cumulative damage, muscle damage, cutaneous damage, calcinosis, lipodystrophy, physical function, and health-related quality of life (HRQOL). A total of 490 patients with a mean disease duration of 7.7 years were included. At the cross-sectional visit, 41.2-52.8% of patients, depending on the instrument used, had reduced muscle strength/endurance, but less than 10% had severe impairment. Persistently active disease was recorded in 41.2-60.5% of the patients, depending on the activity measure used. Sixty-nine percent of the patients had cumulative damage. The frequency of calcinosis and lipodystrophy was 23.6% and 9.7%, respectively. A total of 40.7% of the patients had decreased functional ability, but only 6.5% had major impairment. Only a small fraction had decreased HRQOL. A chronic course, either polycyclic or continuous, consistently predicted a poorer outcome. Mortality rate was 3.1%. This study confirms the marked improvement in functional outcome of juvenile DM when compared with earlier literature. However, many patients had continued disease activity and cumulative damage at followup. A chronic course was the strongest predictor of poor prognosis. These findings highlight the need for treatment strategies that enable a better control of disease activity over time and the reduction of nonreversible damage.

The bacteriological quality of different brands of bottled water available to consumers in Ile-Ife, south-western Nigeria.

PubMed

Igbeneghu, Oluwatoyin A; Lamikanra, Adebayo

2014-11-28

The upsurge in the demand for bottled water has prompted the interest of many manufacturers in the production of bottled water and very many water bottling companies are therefore involved in its production. These range from large scale multinational companies to medium scale business enterprises, institutional and government business investment companies as well as small scale entrepreneurs. There is however little information on the comparative quality of bottled water brands produced by different classes of water bottling companies in Nigeria. This study was undertaken to determine the bacteriological quality of brands of bottled water available to consumers in Ile-Ife. Forty-three samples of bottled water comprising of three batches each of thirteen bottled water brands and two batches of two brands were purchased and analyzed for total bacterial count, presence of coliform and the presence of other bacterial indicators of drinking water quality. Only 67.4% of the water samples representing the products of 10 companies or 66.7% of the brands had heterotrophic counts within the acceptable limits. Coliforms present in 100 ml of water were detected in 26.7% of the bottled water brands. Other indicator organisms detected included Staphylococci isolated from 27.9% of the samples (33.3% of the brands) and specifically Staphylococcus aureus found in four brands constituting 14% of the samples. Pseudomonas strains were consistently detected in consecutive batches of three brands of the water samples. Bottled water samples produced by the large scale multinational producers were of acceptable bacteriological quality unlike those produced by most small companies. There is need for a greater control of water bottling processes carried out by commercial bottled water producers in Nigeria.

Challenges and opportunities of multi-disciplinary, multi-national and multi-sectoral projects

NASA Astrophysics Data System (ADS)

Reitz, Anja; Hamann, Kristin

2017-04-01

Collaborative research projects e.g. funded or supported by the European Commission are by nature multi-national. Often EU calls bring together different scientific communities to jointly tackle challenges that can only be addressed through the convergence of previously separated disciplines in one research consortium. Some work programmes even necessitate to team up as different disciplines as natural sciences, social science, legal science and economic science. Examples for such multi- national, -disciplinary and - sectoral projects are the EU projects ECO2 (FP7, concluded), AtlantOS (H2020) and MiningImpact (JPI Oceans). Project managers of such projects need to develop skills beyond the common technical and management skills namely go into the domain of partners and stakeholders psychology and be able to maintain different perspectives on communication and interaction needs regarding cultural-, discipline- and sectoral background. Accordingly, the project manager has besides his or her technical role as manager at least three further roles: that of a communicator, that of a mediator and that of a person convincing partners of the necessary and selling the project products to the stakeholders. As the typical project manager has not too much power and authority by his or her position he or she has to use the power of smart communication and persuasion to overcome potential dissension between disciplines, national reservation or potential conflicts regarding different sectoral views. Accordingly, the project manager of such complex projects would try to arrange the ideal working environment by considering cultural feel, the cooperation of disciplines, information and the control of resources. The way he or she develops such ideal working environment is by reflection of past, present and future experiences/needs.

The Canadian Forces trauma care system

PubMed Central

Tien, Homer

2011-01-01

According to the Trauma Association of Canada, a trauma system is a preplanned, organized and coordinated injury-control effort in a defined geographic area. An effective trauma system engages in comprehensive injury surveillance and prevention programs; delivers trauma care from the time of injury to recovery; engages in research, training and performance improvement; and establishes linkages with an all-hazards emergency preparedness program. To support Canada’s combat mission in Afghanistan, the Canadian Forces (CF) developed a comprehensive trauma system based around its trauma hospital — the Role 3 Multinational Medical Unit (R3MMU) at Kandahar Airfield. This article reviews the essential components of a modern trauma system, outlines the evidence that trauma systems improve care to injury victims and describes how the current CF trauma system was developed. PMID:22099323

Occupational health and safety of merchant seafarers from Kiribati and Tuvalu.

PubMed

Borovnik, Maria

2011-01-01

Intensifying international competition in the shipping industry in response to global pressures makes seafarers' jobs increasingly difficult. Challenging conditions in ship employment are problematic, particularly in a development context where home communities' dependence on seafarers' income is high and social protection is low. Qualitative fieldwork revealed that seafarers from Kiribati and Tuvalu endure exceptionally lengthy work periods at sea to remain competitive. Absence from home while working in constrained and mobile spaces with multinational crews, frequent security controls and speedy turnarounds impacting on sleep deprivation and decreased shore time have implications for physical and emotional health and can become safety matters. Hence, there is a growing need to address mechanisms to protect seafarers from the physical and emotional effects of global demands in the shipping industry.

The politics of underdevelopment: metered to death-how a water experiment caused riots and a cholera epidemic.

PubMed

Pauw, Jacques

2003-01-01

Water privatization programs in South Africa, part of a government policy aimed at making people pay for the full cost of running water ("total cost recovery"), was developed by private water companies and the World Bank to finance improved water supplies and build the country's economy. Instead the programs are causing more misery than development. Millions of poor people have had their water supply cut off because of inability to pay, forcing them to get their water from polluted rivers and lakes and leading to South Africa's worst cholera outbreak--which the government paid millions of dollars to control. Residents in some townships are rebelling, and many of the private multinational water companies are reassessing their involvement in South Africa.

Challenges of Ophthalmic Care in the Developing World

PubMed Central

Sommer, Alfred; Taylor, Hugh R.; Ravilla, Thulasiraj D.; West, Sheila; Lietman, Thomas M.; Keenan, Jeremy D.; Chiang, Michael F.; Robin, Alan L.; Mills, Richard P.

2014-01-01

Global blindness exacts an enormous financial and social cost on developing countries. Reducing the prevalence of blindness globally requires a set of strategies that are different from those typically employed in developed countries. This was the subject of the 2013 Knapp symposium at the American Ophthalmological Society Annual Meeting, and this article summarizes the presentations of epidemiologists, health care planners, and ophthalmologists. It explores a range of successful strategies from the multinational Vision 2020 Initiative to disease-specific schemes in cataract, trachoma control, infectious corneal ulceration, cytomegalovirus retinitis, and retinopathy of prematurity. In each example, the importance of an attitudinal set towards the public health becomes clear. There is reason for optimism in the struggle against global blindness, in large measure because of innovative programs like those described here. PMID:24604415

Some thoughts on the management of large, complex international space ventures

NASA Technical Reports Server (NTRS)

Lee, T. J.; Kutzer, Ants; Schneider, W. C.

1992-01-01

Management issues relevant to the development and deployment of large international space ventures are discussed with particular attention given to previous experience. Management approaches utilized in the past are labeled as either simple or complex, and signs of efficient management are examined. Simple approaches include those in which experiments and subsystems are developed for integration into spacecraft, and the Apollo-Soyuz Test Project is given as an example of a simple multinational approach. Complex approaches include those for ESA's Spacelab Project and the Space Station Freedom in which functional interfaces cross agency and political boundaries. It is concluded that individual elements of space programs should be managed by individual participating agencies, and overall configuration control is coordinated by level with a program director acting to manage overall objectives and project interfaces.

Maximizing transportation efficiencies and economic impact of the Southwest Missouri foreign-trade zone.

DOT National Transportation Integrated Search

2013-07-01

Overview of Foreign-Trade Zones (FTZ or Zone) and their impact on economic development, goods : movement jobs creation and retention. Zones provide a competitive advantage for multi-national : manufacturing and distribution firms resulting in the ret...

Free Trade: A Misnomer?

ERIC Educational Resources Information Center

McMillan, Robert R.

1983-01-01

Billions of dollars are lost each year in our balance of payments because U.S. multinationals have not entered foreign markets due to trade restrictions and restrictions on the remittance of profits and royalties. Formal and informal government obstructions to free trade are examined. (RM)

Democracy and "Grand" Corruption.

ERIC Educational Resources Information Center

Rose-Ackerman, Susan

1996-01-01

Defines "grand" corruption as that occurring at the higher levels of a political system and involving large sums of money. Discusses the impact and incentives for this level of corruption as well as various government responses. Identifies multinational corporations as the major malefactors. (MJP)

Information Systems and Development in the Third World.

ERIC Educational Resources Information Center

Heitzman, James

1990-01-01

Discussion of the relationship between information and development in Third World countries highlights information systems development in four South Asian nations: India, Pakistan, Sri Lanka, and Bangladesh. The impact of microelectronics technology, development theories, multinational corporations, international information agencies, and…

Beyond Robotics

ERIC Educational Resources Information Center

Tally, Beth; Laverdure, Nate

2006-01-01

Chantilly High School Academy Robotics Team Number 612 from Chantilly, Virginia, is an award-winning team of high school students actively involved with FIRST (For Inspiration and Recognition of Science and Technology), a multinational nonprofit organization that inspires students to transform culture--making science, math, engineering and…

Western Hemisphere Defense Policy Statement

DTIC Science & Technology

2012-10-01

El Salvador , Guatemala, Honduras, Paraguay, Peru and Uruguay have contributed to or led multi-national security operations and United Nations (UN...critical support during the initial stages of the Haiti earthquake relief effort. As military forces often have a unique capability to respond

Organisational Learning: A New Perspective.

ERIC Educational Resources Information Center

O'Keefe, Ted

2002-01-01

A study of Irish multinational companies identified antecedents to organizational learning: nature of global business, anthropomorphism, dissatisfaction with traditional paradigms, customer-responsive culture, and intellectual capital. The path to the learning organization builds on these antecedents in an environment of innovation focused on…

Cost-effectiveness of a complex workplace dietary intervention: an economic evaluation of the Food Choice at Work study.

PubMed

Fitzgerald, Sarah; Murphy, Aileen; Kirby, Ann; Geaney, Fiona; Perry, Ivan J

2018-03-03

To evaluate the costs, benefits and cost-effectiveness of complex workplace dietary interventions, involving nutrition education and system-level dietary modification, from the perspective of healthcare providers and employers. Single-study economic evaluation of a cluster-controlled trial (Food Choice at Work (FCW) study) with 1-year follow-up. Four multinational manufacturing workplaces in Cork, Ireland. 517 randomly selected employees (18-65 years) from four workplaces. Cost data were obtained from the FCW study. Nutrition education included individual nutrition consultations, nutrition information (traffic light menu labelling, posters, leaflets and emails) and presentations. System-level dietary modification included menu modification (restriction of fat, sugar and salt), increase in fibre, fruit discounts, strategic positioning of healthier alternatives and portion size control. The combined intervention included nutrition education and system-level dietary modification. No intervention was implemented in the control. The primary outcome was an improvement in health-related quality of life, measured using the EuroQoL 5 Dimensions 5 Levels questionnaire. The secondary outcome measure was reduction in absenteeism, which is measured in monetary amounts. Probabilistic sensitivity analysis (Monte Carlo simulation) assessed parameter uncertainty. The system-level intervention dominated the education and combined interventions. When compared with the control, the incremental cost-effectiveness ratio (€101.37/quality-adjusted life-year) is less than the nationally accepted ceiling ratio, so the system-level intervention can be considered cost-effective. The cost-effectiveness acceptability curve indicates there is some decision uncertainty surrounding this, arising from uncertainty surrounding the differences in effectiveness. These results are reiterated when the secondary outcome measure is considered in a cost-benefit analysis, whereby the system-level intervention yields the highest net benefit (€56.56 per employee). System-level dietary modification alone offers the most value per improving employee health-related quality of life and generating net benefit for employers by reducing absenteeism. While system-level dietary modification strategies are potentially sustainable obesity prevention interventions, future research should include long-term outcomes to determine if improvements in outcomes persist. ISRCTN35108237; Post-results. © Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2018. All rights reserved. No commercial use is permitted unless otherwise expressly granted.

International trade regulation and publicly funded health care in Canada.

PubMed

Ostry, A S

2001-01-01

The World Trade Organization (WTO) creates new challenges for the Canadian health care system, arguably one of the most "socialized" systems in the world today. In particular, the WTO's enhanced trade dispute resolution powers, enforceable with sanctions, may make Canadian health care vulnerable to corporate penetration, particularly in the pharmaceutical and private health services delivery sectors. The Free Trade Agreement and its extension, the North American Free Trade Agreement, gave multinational pharmaceutical companies greater freedom in Canada at the expense of the Canadian generic drug industry. Recent challenges by the WTO have continued this process, which will limit the health care system's ability to control drug costs. And pressure is growing, through WTO's General Agreement on Trade in Services and moves by the Alberta provincial government to privatize health care delivery, to open up the Canadian system to corporate penetration. New WTO agreements will bring increasing pressure to privatize Canada's public health care system and limit government's ability to control pharmaceutical costs.

Zolpidem efficacy and safety in disorders of consciousness.

PubMed

Machado, Calixto; Estévez, Mario; Rodriguez-Rojas, Rafael

2018-01-01

Sutton and Clauss presented a detailed review about the effectiveness of zolpidem, discussing recoveries from brain damage due to strokes, trauma and hypoxia. A significant finding has been the unexpected and paradoxical increment of brain activity in vegetative state/unresponsive wakefulness syndrome (VS/UWS). On the contrary, zolpidem is considered one of the best sleep inducers in normal subjects. We have studied series of VS/UWS cases after zolpidem intake. We have demonstrated EEG activation, increment of BOLD signal in different brain regions, and an autonomic influence, mainly characterized by a vagolytic chronotropic effect without a significant increment of the vasomotor sympathetic tone. As this autonomic imbalance might induce cardio- circulatory complications, which we didn't find in any of our patients, we suggest developing future trials under control of physiological indices by bedside monitoring. However, considering that the paradoxical arousing zolpidem effect might be certainly related to brain function improvement, we agree with Sutton and Clauss that future multicentre and multinational clinical trials should be developed, but under control of physiological indices.

Control of Risk Factors for Cardiovascular Disease among Multinational Patient Population in the Arabian Gulf

PubMed Central

Al-Zakwani, Ibrahim; Al-Mahmeed, Wael; Arafah, Mohamed; Al-Hinai, Ali T.; Shehab, Abdullah; Al-Tamimi, Omer; Al-Awadhi, Mahmoud; Al-Herz, Shorook; Al-Anazi, Faisal; Al-Nemer, Khalid; Metwally, Othman; Al-Khadra, Akram; Fakhry, Mohammed; Elghetany, Hossam; Medani, Abdel R.; Yusufali, Afzal H.; Al-Jassim, Obaid; Al-Hallaq, Omar; Baslaib, Fahad O.A.S.; Amin, Haitham; Santos, Raul D.; Al-Waili, Khalid; Al-Hashmi, Khamis; Al-Rasadi, Khalid

2016-01-01

We evaluated the control of cardiovascular disease (CVD) risk factors among patients with atherosclerotic cardiovascular disease (ASCVD) in the Centralized Pan-Middle East Survey on the undertreatment of hypercholesterolaemia (CEPHEUS) in the Arabian Gulf. Of the 4398 enrolled patients, overall mean age was 57 ± 11 years, 60% were males, 13% were smokers, 76% had diabetes, 71% had metabolic syndrome and 78% had very high ASCVD risk status. The proportion of subjects with body mass index <25 kg/m2, HbA1c <7% (in diabetics), low-density lipoprotein cholesterol (LDL-C) <2.6 mmol/L (100 mg/dL) and <1.8 mmol/L (70 mg/dL) for high and very high ASCVD risk cohorts, respectively and controlled blood pressure (<140/90 mmHg) was 14, 26, 31% and 60%, respectively. Only 1.4% of the participants had all of their CVD risk factors controlled with significant differences among the countries (P < .001). CVD risk goal attainment rates were significantly lower in those with very high ASCVD risk compared with those with high ASCVD risk status (P < .001). Females were also, generally, less likely to attain goals when compared with males (P < .001). PMID:26496982

Global Personality Norms: Multicultural, Multinational, and Managerial

ERIC Educational Resources Information Center

Oswald, Frederick L.

2008-01-01

The critical importance of understanding, selecting, and developing global management talent--management operating within internationally diverse interpersonal and situational contexts--has emerged from the increasing globalization of business and the concomitant high rates of immigration, emigration, and expatriation. With an awareness of this…

22 CFR 3.3 - Definitions.

Code of Federal Regulations, 2010 CFR

2010-04-01

... governmental authority, including any foreign national, State, local, or municipal government; (2) any international or multinational organization whose membership is composed of any unit of foreign government as... organization, while acting as such; (c) Gift means a tangible or intangible present (other than a decoration...

Restorers of Hope: Shaping Conditions for Success Against Al-Qaeda’s Regional Insurgency

DTIC Science & Technology

2003-01-01

government of Afghanistan in their most important projects, including building the Teachers Training College, the Artificial Insemination Farm, and the...West; multinational corporations; international communications and data exchange systems; international news agencies and satellite media channels; and

Integrating International Business Law Concepts into a High School Business Law Course.

ERIC Educational Resources Information Center

Golden, Cathleen J.; McDonald, Michael L.

1998-01-01

Outlines international business content for a high school business law curriculum: history of international business law, World Trade Organization, international disputes, contracts and sales, financing/banking, currency, taxation, intellectual property, transportation, and multinational corporations. Considers whether to teach international…

International Universities: Misunderstandings and Emerging Models?

ERIC Educational Resources Information Center

Knight, Jane

2015-01-01

Internationalization has transformed higher education institutions and systems but there is much confusion as to what an international, binational, transnational, cosmopolitan, multinational, or global university actually means. There is no standardized model for an international university, nor should there be, but a deeper understanding of…

International Issues in Education

ERIC Educational Resources Information Center

Ruggeri, Kai; Diaz, Carmen; Kelley, Karl; Papousek, Ilona; Dempster, Martin; Hanna, Donncha

2008-01-01

Anxiety, negative attitudes, and attrition are all issues presented in the teaching of statistics to undergraduates in research-based degrees regardless of location. Previous works have looked at these obstacles, but none have consolidated a multilingual, multinational effort using a consistent method. Over 400 Spanish-, English-, and…

Evolving Service Poles in Presence Missions.

DTIC Science & Technology

1995-08-01

were trained, equipped, deployed and re-deployed t-.hrough FMF; e.g., Morocco in Somalia and S*n* ga , Nigeria, Ghana, Siarra Leone. Uganda, and TanzarH...Mongolia, Nopal , and Bangladesh, military outraach programs, including parsonnsl exchanges and multinational conferences, provide some of our basic

Is car use related with successful aging of older adults? Results from the multinational Mediterranean islands study.

PubMed

Tyrovolas, Stefanos; Polychronopoulos, Evangelos; Morena, Marianthi; Mariolis, Anargiros; Piscopo, Suzanne; Valacchi, Giuseppe; Bountziouka, Vassiliki; Anastasiou, Foteini; Zeimbekis, Akis; Tyrovola, Dimitra; Foscolou, Alexandra; Gotsis, Efthimios; Metallinos, George; Soulis, George; Tur, Josep-Antoni; Matalas, Antonia; Lionis, Christos; Sidossis, Labros S; Panagiotakos, Demosthenes

2017-03-01

The aim of the present work was to evaluate the relation between car use and the level of successful aging of a random sample of older adults living in the Mediterranean basin. During 2005-2011, 2749 older (aged 65-100 years) from 22 islands and the rural Mani region (Peloponnesus) of Greece were voluntarily enrolled in the Mediterranean islands cross-sectional study. Sociodemographics, medical conditions, and dietary and lifestyle habits were derived throughout standard procedures. Car use was recorded with a standard binary question. A successful aging index ranging from 0-10 was used. Older adults who used a car on regular basis had significantly higher levels of successful aging, as well as less prevalence of obesity and hypertension while were more physically active (P < .001). After adjusting for several confounders car use was still positively related with elderly islander's successful aging level (beta coefficient [95% confidence interval]: 0.65 [0.54-0.77]). In conclusion, the activity of car use seems to be an indicator of quality of life among older adults, as measured through successful aging. Copyright © 2017 Elsevier Inc. All rights reserved.

Beneficial effect of azathioprine and prediction of prognosis in primary biliary cirrhosis. Final results of an international trial.

PubMed

Christensen, E; Neuberger, J; Crowe, J; Altman, D G; Popper, H; Portmann, B; Doniach, D; Ranek, L; Tygstrup, N; Williams, R

1985-11-01

The effect of azathioprine on survival of patients with primary biliary cirrhosis was studied prospectively in a multinational, double-blind, randomized clinical trial including 248 patients of whom 127 received azathioprine and 121 placebo. There were 57 deaths in the azathioprine group and 62 in the placebo group. The actual survival was slightly longer during azathioprine than during placebo treatment. Using Cox multiple regression analysis and adjusting for slight imbalance between the two treatment groups, the therapeutic effect of azathioprine was statistically significant (p = 0.01), with azathioprine reducing the risk of dying to 59% of that observed during placebo treatment (95% confidence interval 40%-90%) or improving survival time by 20 mo in the average patient. Furthermore, azathioprine slowed down progressing incapacitation. Side effects of azathioprine were relatively few. The analysis revealed that the following five variables independently implied poor prognosis: high serum bilirubin, old age, cirrhosis, low serum albumin, and central cholestasis. These factors were combined to a "prognostic index" for prediction of outcome in new patients. The index was validated on independent patient data. On the basis of these results we recommend azathioprine as a routine treatment of primary biliary cirrhosis.

Vardenafil orodispersible tablet.

PubMed

Sanford, Mark

2012-01-01

Vardenafil orodispersible tablet (ODT) is a supralingual formulation of vardenafil that is available for the on-demand treatment of erectile dysfunction. The pharmacokinetics of vardenafil ODT are not equivalent to those of the vardenafil film-coated tablet in that the ODT formulation provides consistently greater vardenafil systemic exposure. Therefore, the two formulations are not interchangeable. The efficacy of on-demand vardenafil ODT 10 mg was established in the POTENT I and II studies, which were 6-week, randomized, double-blind, multinational trials in men with erectile dysfunction of at least 6 months duration. In both trials, vardenafil ODT improved erectile function significantly more than placebo, as indicated by International Index of Erectile Function-Erectile Function subscale scores at week 12 and overall erection success rates during treatment according to responses to questions 2 and 3 of the Sexual Encounter Profile (coprimary endpoints). In a pooled analysis of both trials, vardenafil ODT improved erectile function regardless of age, severity of erectile dysfunction at baseline or the presence or absence of underlying medical conditions. Vardenafil ODT was generally well tolerated in clinical trials, including in men aged ≥65 years, and adverse events were mostly mild or moderate in severity.

Corporate social responsibility in global health: an exploratory study of multinational pharmaceutical firms.

PubMed

Droppert, Hayley; Bennett, Sara

2015-04-09

As pharmaceutical firms experience increasing civil society pressure to act responsibly in a changing globalized world, many are expanding and/or reforming their corporate social responsibility (CSR) strategies. We sought to understand how multinational pharmaceutical companies currently engage in CSR activities in the developing world aimed at global health impact, their motivations for doing so and how their CSR strategies are evolving. We conducted a small-scale, exploratory study combining (i) an in-depth review of publicly available data on pharmaceutical firms' CSR with (ii) interviews of representatives from 6 firms, purposively selected, from the highest earning pharmaceutical firms worldwide. Corporate social responsibility differed for each firm particularly with respect to how CSR is defined, organizational structures for managing CSR, current CSR activities, and motivations for CSR. Across the firms studied, the common CSR activities were: differential pharmaceutical pricing, strengthening developing country drug distribution infrastructure, mHealth initiatives, and targeted research and development. Primary factors that motivated CSR engagement were: reputational benefits, recruitment and employee satisfaction, better rankings in sustainability indices, entrance into new markets, long-term economic returns, and improved population health. In terms of CSR strategy, firms were at different points on a spectrum ranging from philanthropic donations to integrated systemic shared value business models. CSR is of increasing importance for multinational pharmaceutical firms yet understanding of the array of CSR strategies employed and their effects is nascent. Our study points to the need to (i) develop clearer and more standardized definitions of CSR in global health (2) strengthen indices to track CSR strategies and their public health effects in developing countries and (iii) undertake more country level studies that investigate how CSR engages with national health systems.

Scorched earth: will environmental risks in China overwhelm its opportunities?

PubMed

Economy, Elizabeth; Lieberthal, Kenneth

2007-06-01

Of all the risks of doing business in China, the greatest is the threat posed by environmental degradation. And yet it's barely discussed in corporate boardrooms. This is a serious mistake. Multinationals may be more concerned with intellectual property rights violations, corruption, and potential political instability, but the Chinese government, NGOs, and the Chinese press have been focused squarely on the country's energy shortages, soil erosion, lack of water, and pollution problems, which are so severe they might constrain GDP growth. What's more, the Chinese expect the international community to take the lead in environmental protection. If that doesn't happen, multinationals face clear risks to their operations, their workers' health, and their reputations. In factoring environmental issues into their China strategies, foreign firms need to be both defensive, taking steps to reduce harm, and proactive, investing in environmental protection efforts. Coca-Cola, for example, installed state-of-the-art bottling plants in China that operate with no net loss of water resources. Mattel increased the safety of its Barbie-manufacturing process to protect workers' health. With its efforts to reduce greenhouse gas emissions, GE is shrinking its environmental footprint in China; more proactively, GE is working closely with the Chinese government and scientists to develop clean coal, water purification, and water reuse technologies. In considering the value of such efforts, companies can not only factor in reduced risk but also increased opportunity, as they use innovations designed for the Chinese market in the rest of the world. The bottom line: How well multinationals address environmental issues in China will affect their fortunes in one of the most important economies in the world.

Multinational evidence-based recommendations on how to investigate and follow-up undifferentiated peripheral inflammatory arthritis: integrating systematic literature research and expert opinion of a broad international panel of rheumatologists in the 3E Initiative

PubMed Central

Machado, P; Castrejon, I; Katchamart, W; Koevoets, R; Kuriya, B; Schoels, M; Silva-Fernández, L; Thevissen, K; Vercoutere, W; Villeneuve, E; Aletaha, D; Carmona, L; Landewé, R; van der Heijde, D; Bijlsma, J W J; Bykerk, V; Canhão, H; Catrina, A I; Durez, P; Edwards, C J; Mjaavatten, M D; Leeb, B F; Losada, B; Martín-Mola, E M; Martinez-Osuna, P; Montecucco, C; Müller-Ladner, U; Østergaard, M; Sheane, B; Xavier, R M; Zochling, J; Bombardier, C

2011-01-01

Objective To develop evidence-based recommendations on how to investigate and follow-up undifferentiated peripheral inflammatory arthritis (UPIA). Methods 697 rheumatologists from 17 countries participated in the 3E (Evidence, Expertise, Exchange) Initiative of 2008–9 consisting of three separate rounds of discussions and modified Delphi votes. In the first round 10 clinical questions were selected. A bibliographic team systematically searched Medline, Embase, the Cochrane Library and ACR/EULAR 2007–2008 meeting abstracts. Relevant articles were reviewed for quality assessment, data extraction and synthesis. In the second round each country elaborated a set of national recommendations. Finally, multinational recommendations were formulated and agreement among the participants and the potential impact on their clinical practice was assessed. Results A total of 39 756 references were identified, of which 250 were systematically reviewed. Ten multinational key recommendations about the investigation and follow-up of UPIA were formulated. One recommendation addressed differential diagnosis and investigations prior to establishing the operational diagnosis of UPIA, seven recommendations related to the diagnostic and prognostic value of clinical and laboratory assessments in established UPIA (history and physical examination, acute phase reactants, autoantibodies, radiographs, MRI and ultrasound, genetic markers and synovial biopsy), one recommendation highlighted predictors of persistence (chronicity) and the final recommendation addressed monitoring of clinical disease activity in UPIA. Conclusions Ten recommendations on how to investigate and follow-up UPIA in the clinical setting were developed. They are evidence-based and supported by a large panel of rheumatologists, thus enhancing their validity and practical use. PMID:20724311

Multinational evidence-based recommendations for the use of methotrexate in rheumatic disorders with a focus on rheumatoid arthritis: integrating systematic literature research and expert opinion of a broad international panel of rheumatologists in the 3E Initiative

PubMed Central

Visser, K; Katchamart, W; Loza, E; Martinez-Lopez, J A; Salliot, C; Trudeau, J; Bombardier, C; Carmona, L; van der Heijde, D; Bijlsma, J W J; Boumpas, D T; Canhao, H; Edwards, C J; Hamuryudan, V; Kvien, T K; Leeb, B F; Martín-Mola, E M; Mielants, H; Müller-Ladner, U; Murphy, G; Østergaard, M; Pereira, I A; Ramos-Remus, C; Valentini, G; Zochling, J; Dougados, M

2009-01-01

Objectives: To develop evidence-based recommendations for the use of methotrexate in daily clinical practice in rheumatic disorders. Methods: 751 rheumatologists from 17 countries participated in the 3E (Evidence, Expertise, Exchange) Initiative of 2007–8 consisting of three separate rounds of discussions and Delphi votes. Ten clinical questions concerning the use of methotrexate in rheumatic disorders were formulated. A systematic literature search in Medline, Embase, Cochrane Library and 2005–7 American College of Rheumatology/European League Against Rheumatism meeting abstracts was conducted. Selected articles were systematically reviewed and the evidence was appraised according to the Oxford levels of evidence. Each country elaborated a set of national recommendations. Finally, multinational recommendations were formulated and agreement among the participants and the potential impact on their clinical practice was assessed. Results: A total of 16 979 references was identified, of which 304 articles were included in the systematic reviews. Ten multinational key recommendations on the use of methotrexate were formulated. Nine recommendations were specific for rheumatoid arthritis (RA), including the work-up before initiating methotrexate, optimal dosage and route, use of folic acid, monitoring, management of hepatotoxicity, long-term safety, mono versus combination therapy and management in the perioperative period and before/during pregnancy. One recommendation concerned methotrexate as a steroid-sparing agent in other rheumatic diseases. Conclusions: Ten recommendations for the use of methotrexate in daily clinical practice focussed on RA were developed, which are evidence based and supported by a large panel of rheumatologists, enhancing their validity and practical use. PMID:19033291

Clomifene citrate or low-dose FSH for the first-line treatment of infertile women with anovulation associated with polycystic ovary syndrome: a prospective randomized multinational study.

PubMed

Homburg, R; Hendriks, M L; König, T E; Anderson, R A; Balen, A H; Brincat, M; Child, T; Davies, M; D'Hooghe, T; Martinez, A; Rajkhowa, M; Rueda-Saenz, R; Hompes, P; Lambalk, C B

2012-02-01

Clomifene citrate (CC) is accepted as the first-line method for ovulation induction (OI) in patients with polycystic ovary syndrome (PCOS) associated with infertility owing to anovulation. Low-dose FSH has been reserved for women failing to conceive with CC. In this RCT, we tested the hypothesis that pregnancy rate (PR) and live birth rates (LBR) are higher after OI with low-dose FSH than with CC as first-line treatment. Infertile women (<40 years old) with PCOS-related anovulation, without prior OI treatment, attending 10 centres in Europe/South America were randomized to OI with either CC (50-150 mg/day for 5 days) or FSH (starting dose 50 IU) for up to three treatment cycles. The primary outcome was clinical PR. Patients (n = 302) were randomized to OI with FSH (n = 132 women; 288 cycles) or CC (n = 123; 310 cycles). Per protocol analysis revealed that reproductive outcome was superior after OI with FSH than with CC with respect to PR per first cycle [30 versus 14.6%, respectively, 95% confidence interval (CI) 5.3-25.8, P = 0.003], PR per woman, (58 versus 44% of women, 95% CI 1.5-25.8, P = 0.03), LBR per woman (52 versus 39%, 95% CI 0.4-24.6, P = 0.04), cumulative PR (52.1 versus 41.2%, P = 0.021) and cumulative LBR (47.4 versus 36.9%, P = 0.031), within three cycles of OI. Pregnancies and live births are achieved more effectively and faster after OI with low-dose FSH than with CC. This result has to be balanced by convenience and cost in favour of CC. FSH may be an appropriate first-line treatment for some women with PCOS and anovulatory infertility, particularly older patients.

Prophylaxis vs. on-demand treatment with BAY 81-8973, a full-length plasma protein-free recombinant factor VIII product: results from a randomized trial (LEOPOLD II).

PubMed

Kavakli, K; Yang, R; Rusen, L; Beckmann, H; Tseneklidou-Stoeter, D; Maas Enriquez, M

2015-03-01

BAY 81-8973 is a new full-length human recombinant factor VIII product manufactured with technologies to improve consistency in glycosylation and expression to optimize clinical performance. To demonstrate superiority of prophylaxis vs. on demand therapy with BAY 81-8973 in patients with severe hemophilia A. In this multinational,randomized, open-label crossover study (LEOPOLD II;ClinicalTrials.gov identifier: NCT01233258), males aged 12–65 years with severe hemophilia A were randomized to twice-weekly prophylaxis (20-30 IU kg(-1)), 3-times-weekly prophylaxis (30-40 IU kg(-1)), or on-demand treatment with BAY 81-8973. Potency labeling for BAY 81-8973 was based on the chromogenic substrate assay or adjusted to the one-stage assay. Primary efficacy endpoint was annualized number of all bleeds (ABR). Adverse events (AEs)and immunogenicity were also assessed. Eighty patients (on demand, n = 21; twice-weekly prophylaxis, n = 28; 3-times-weekly prophylaxis, n = 31) were treated and analyzed. Mean ± SD ABR was significantly lower with prophylaxis (twice-weekly, 5.7 ± 7.2; 3-times-weekly, 4.3 ± 6.5; combined, 4.9 ± 6.8) vs. on-demand treatment (57.7 ± 24.6; P < 0.0001, ANOVA). Median ABR was reduced by 97% with prophylaxis (twice-weekly, 4.0;3-times-weekly, 2.0; combined, 2.0) vs. on-demand treatment (60.0). Median ABR was higher with twice-weekly vs. 3-times-weekly prophylaxis during the first 6-month treatment period (4.1 vs. 2.0) but was comparable in the second 6-month period (1.1 vs. 2.0). Few patients reported treatment-related AEs (4%); no treatment-related serious AEs or inhibitors were reported. Twice weekly or 3-times-weekly prophylaxis with BAY 81-8973 reduced median ABR by 97% compared with on-demand therapy, confirming the superiority of prophylaxis. Treatment with BAY 81-8973 was well tolerated.

Intensive Language Training for Multinational Business

ERIC Educational Resources Information Center

Jordan, Gerda

1977-01-01

A two-year master's degree program in international business studies was initiated by the College of Business Administration at the University of South Carolina to educate the business manager who will deal with foreign countries. The language component comprises an important part of the program. (SW)

Multinational Species Conservation Funds Semipostal Stamp Reauthorization Act of 2012

THOMAS, 112th Congress

Sen. Portman, Rob [R-OH

2012-05-21

Senate - 09/14/2012 Committee on Homeland Security and Governmental Affairs referred to Subcommittee on Federal Financial Management, Government Information, Federal Services, and International Security. (All Actions) Tracker: This bill has the status IntroducedHere are the steps for Status of Legislation:

Diversity in the Workplace. Symposium.

ERIC Educational Resources Information Center

2002

Three papers comprise this symposium on diversity in the workplace. "Factors That Assist and Barriers That Hinder the Success of Diversity Initiatives in Multinational Corporations" (Rose Mary Wentling) reports that factors that assisted in the success were classified under diversity department, human, and work environment; barriers were…

Eastern Europe's Silicon Rush

ERIC Educational Resources Information Center

Woodard, Colin

2007-01-01

This article presents how the fast expansion of information technology industry in eastern Slovakia is putting a strain on its labor supply. Suddenly, computer-science graduates have become one of the former Eastern Bloc's greatest assets, attracting multinational technology companies hungry for skilled programmers, technicians, and engineers.…

When Going Global Isn't Enough.

ERIC Educational Resources Information Center

Randolph, Benton

1990-01-01

The traditional multinational approach to business strategy and human resource management, as well as the global approach, are not effective in a world no longer insular. A transnational approach requires global strategy and perspective, local responsiveness and flexibility, teamwork, shared responsibility, and empowered and innovative workers.…

Innovative eLearning: Technology Shaping Contemporary Problem Based Learning: A Cross-Case Analysis

ERIC Educational Resources Information Center

Blackburn, Greg

2015-01-01

Preparing students to be critical thinkers and effective communicators is essential in today's multinational and technologically sophisticated environment. New electronic technologies provide opportunities for creating learning environments that extend the possibilities of "old" but still essential technologies: books, blackboards, and…

Coping with the Economic Order through the Big Mac

ERIC Educational Resources Information Center

Akenson, James E.

1977-01-01

Describes an economic education unit for use in the elementary classroom which employs a case study of McDonalds hamburger chain to teach students about multinational corporations, mass production, standardization, advertising, and capital investment. For journal availability, see SO 505 448. (Author/DB)

An International Bioinformatics Infrastructure to Underpin the Arabidopsis Community

USDA-ARS?s Scientific Manuscript database

The future bioinformatics needs of the Arabidopsis community as well as those of other scientific communities that depend on Arabidopsis resources were discussed at a pair of recent meetings held by the Multinational Arabidopsis Steering Committee (MASC) and the North American Arabidopsis Steering C...

Factors affecting breastfeeding practices among working women in Pakistan.

PubMed

Soomro, J A; Shaikh, Z N; Bijarani, S A; Saheer, T B

2017-02-01

In urban areas of Pakistan, women's return to work after giving birth has frequently been found to be a main contributor to the early termination of breastfeeding. This study aimed to assess workplace breastfeeding support provided to working mothers in Pakistan. In a cross-sectional survey in 2014, mothers and employers from a representative sample of 297 workplaces were interviewed using a pre-tested questionnaire. Mothers from 36 (12.1%) sites reported receiving breastfeeding breaks, and 86% of the mothers had received 3 months paid maternity leave. Provision of a lighter job and information about breastfeeding options on return to work were reported from 15% and 5% of the workplaces, respectively. Only two sites had designated breastfeeding corners. Significantly different results were found between types of employer (government or private) and type of organization (national or multinational) with regard to breastfeeding breaks, breastfeeding corners, lighter jobs and paid maternity leave. Public and multinational companies were slightly better than private and national ones in providing breastfeeding facilities.

Reliability (internal consistency) of the job content questionnaire on job stress among office workers of a multinational company in Kuala Lumpur.

PubMed

Maizura, Husna; Masilamani, Retneswari; Aris, Tahir

2009-04-01

This small, cross-sectional study assessed the reliability of 3 scales from the Job Content Questionnaire (JCQ)-decision latitude, psychological job demand, and social support-in a group of office workers in a multinational company in Kuala Lumpur. A universal sample of 30 white-collar workers from a department of the company self-administered the English version of the JCQ comprising 21 core items selected from the full recommended version of 49 items on-site. Reliability (internal consistency) was evaluated using Cronbach's alpha coefficients for each scale. Corrected item-total correlation was presented for each and every item. Cronbach's alpha coefficients were acceptable for decision latitude (.76) and social support (.79) but slightly lower for psychological job demand (.64). Values for all item-total correlations for all 3 scales were greater than .3. In conclusion, this study suggests that the JCQ is a reliable scale for assessing job stress in this group of workers.

A national study of the association between neighbourhood access to fast-food outlets and the diet and weight of local residents.

PubMed

Pearce, Jamie; Hiscock, Rosemary; Blakely, Tony; Witten, Karen

2009-03-01

Differential locational access to fast-food retailing between neighbourhoods of varying socioeconomic status has been suggested as a contextual explanation for the social distribution of diet-related mortality and morbidity. This New Zealand study examines whether neighbourhood access to fast-food outlets is associated with individual diet-related health outcomes. Travel distances to the closest fast-food outlet (multinational and locally operated) were calculated for all neighbourhoods and appended to a national health survey. Residents in neighbourhoods with the furthest access to a multinational fast-food outlet were more likely to eat the recommended intake of vegetables but also be overweight. There was no association with fruit consumption. Access to locally operated fast-food outlets was not associated with the consumption of the recommended fruit and vegetables or being overweight. Better neighbourhood access to fast-food retailing is unlikely to be a key contextual driver for inequalities in diet-related health outcomes in New Zealand.

"Asia is now the priority target for the world anti-tobacco movement": attempts by the tobacco industry to undermine the Asian anti-smoking movement

PubMed Central

Knight, J; Chapman, S

2004-01-01

Study objective: To identify and examine the strategies utilised by multinational tobacco companies to undermine and discredit key anti-tobacco activists and organisations in the Asian region. Method: A series of case studies drawing upon material gathered through systematic reviews of internal tobacco industry documents. Date sources: Tobacco industry documents made public as part of the settlement of the Minnesota Tobacco Trial and the Master Settlement Agreement. Results: The industry sought to identify, monitor, and isolate key individuals and organisations. The way industry went about fulfilling this mandate in the Asian region is discussed. Industry targetted individuals and agencies along with the region's primary anti-smoking coalition. Conclusions: Attack by multinational tobacco companies is a virtual quid pro quo for any individual or agency seriously challenging industry practices and policies. Understanding their tactics allows anticipatory strategies to be developed to minimise the effectiveness of these attacks. PMID:15564217

An international comparison study of pharmacy students' achievement goals and their relationship to assessment type and scores.

PubMed

Alrakaf, Saleh; Anderson, Claire; Coulman, Sion A; John, Dai N; Tordoff, June; Sainsbury, Erica; Rose, Grenville; Smith, Lorraine

2015-04-25

To identify pharmacy students' preferred achievement goals in a multi-national undergraduate population, to investigate achievement goal preferences across comparable degree programs, and to identify relationships between achievement goals, academic performance, and assessment type. The Achievement Goal Questionnaire was administered to second year students in 4 universities in Australia, New Zealand, England, and Wales. Academic performance was measured using total scores, multiple-choice questions, and written answers (short essay). Four hundred eighty-six second year students participated. Students showed an overall preference for the mastery-approach goal orientation across all sites. The predicted relationships between goal orientation and multiple-choice questions, and written answers scores, were significant. This study is the first of its kind to examine pharmacy students' achievement goals at a multi-national level and to differentiate between assessment type and measures of achievement motivation. Students adopting a mastery-approach goal are more likely to gain high scores in assessments that measure understanding and depth of knowledge.

An International Comparison Study of Pharmacy Students’ Achievement Goals and their Relationship to Assessment Type and Scores

PubMed Central

Anderson, Claire; Coulman, Sion A.; John, Dai N.; Tordoff, June; Sainsbury, Erica; Rose, Grenville; Smith, Lorraine

2015-01-01

Objective: To identify pharmacy students’ preferred achievement goals in a multi-national undergraduate population, to investigate achievement goal preferences across comparable degree programs, and to identify relationships between achievement goals, academic performance, and assessment type. Methods: The Achievement Goal Questionnaire was administered to second year students in 4 universities in Australia, New Zealand, England, and Wales. Academic performance was measured using total scores, multiple-choice questions, and written answers (short essay). Results: Four hundred eighty-six second year students participated. Students showed an overall preference for the mastery-approach goal orientation across all sites. The predicted relationships between goal orientation and multiple-choice questions, and written answers scores, were significant. Conclusion: This study is the first of its kind to examine pharmacy students’ achievement goals at a multi-national level and to differentiate between assessment type and measures of achievement motivation. Students adopting a mastery-approach goal are more likely to gain high scores in assessments that measure understanding and depth of knowledge. PMID:25995510

Privatization and the globalization of energy markets

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

NONE

1996-10-01

This report reviews recent global efforts to privatize energy resources and outlines the opportunities and challenges privatization has presented to U.S. and foreign multinational energy companies. The group of energy companies studied in this report includes the major U.S. petroleum companies and many foreign companies. The foreign companies reviewed include state-run energy enterprises, recently privatized energy enterprises, and foreign multinationals that have been privately held. The privatization of non-petroleum energy industries, such as electricity generation and transmission, natural gas transmission, and coal mining, are also discussed. Overseas investments made by electric companies, natural gas companies, and coal companies are included.more » The report is organized into six chapters: (1) economics of privatization; (2) petroleum privatization efforts among non-U.S. Organization for Economic Cooperation and Development nations; (3) petroleum privatization efforts in Latin America; (4) privatization in socialist and former socialist regimes; (5) privatization efforts in global electric power generation, transmission, and distribution industries; and (6) privatization and globalization of world coal.« less

National Differences in Requirements for Ethical and Competent Authority Approval for a Multinational Vaccine Trial under the EU Directive 2001/20/EC

PubMed Central

van Doorn, Eva; Hak, Eelko; Wilffert, Bob

2015-01-01

Obtaining approval for a multinational vaccine trial from an ethics committee and the national competent authority of different Member States of the European Union (EU) is challenging under clinical trial Directive 2001/20/EC because of the differences in the implementation of the directive in national laws of Member States. In this review the national differences in requirements for ethical and competent authority approval are illustrated. The national ethical and competent authority review procedures in Finland, Hungary, The Netherlands, Norway and Slovenia are described under the EU trial directive after discussing the provisions of the trial directive related to both review procedures. The review illustrates the differences between the countries in the documents that have to be submitted for the review procedures, the submission procedures and the language requirements of the documents, the organization of the ethics committees and the role of the competent authority in the approval procedure. PMID:26343188

National Differences in Requirements for Ethical and Competent Authority Approval for a Multinational Vaccine Trial under the EU Directive 2001/20/EC.

PubMed

van Doorn, Eva; Hak, Eelko; Wilffert, Bob

2015-04-14

Obtaining approval for a multinational vaccine trial from an ethics committee and the national competent authority of different Member States of the European Union (EU) is challenging under clinical trial Directive 2001/20/EC because of the differences in the implementation of the directive in national laws of Member States. In this review the national differences in requirements for ethical and competent authority approval are illustrated. The national ethical and competent authority review procedures in Finland, Hungary, The Netherlands, Norway and Slovenia are described under the EU trial directive after discussing the provisions of the trial directive related to both review procedures. The review illustrates the differences between the countries in the documents that have to be submitted for the review procedures, the submission procedures and the language requirements of the documents, the organization of the ethics committees and the role of the competent authority in the approval procedure.

The Role 3 Multinational Medical Unit at Kandahar Airfield 2005–2010

PubMed Central

Brisebois, Ronald; Hennecke, Peter; Kao, Raymond; McAlister, Vivian; Po, Joseph; Stiegelmar, Rob; Tien, Homer

2011-01-01

In late 2005, Canadian Forces Health Services (CFHS) was tasked with the command of the NATO Role 3 Multinational Medical Unit (R3MMU) on Kandahar Airfield in southern Afghanistan. Preparations drew on past experience and planning. Eight complete hospital contingents were trained and deployed in rotation. Near-reality simulation training was undertaken with the combat brigade, including complete deployment of the field hospital in the exercise area. Standard operating procedures (SOP) were developed and applied by each rotation so successfully that they were adopted by the new command in late 2009. The Canadian period at R3MMU had the highest survival rate ever recorded for victims of war. Lessons learned are being applied among victims of the conflict and trauma. The experience of the R3MMU was used to successfully deploy a hospital as part of the earthquake relief effort in Haiti in 2010. The training protocols and SOP are being applied to disaster preparedness in Canadian civilian hospitals. PMID:22099325

The Role 3 Multinational Medical Unit at Kandahar Airfield 2005-2010.

PubMed

Brisebois, Ronald; Hennecke, Peter; Kao, Raymond; McAlister, Vivian; Po, Joseph; Stiegelmar, Rob; Tien, Homer

2011-12-01

In late 2005, Canadian Forces Health Services (CFHS) was tasked with the command of the NATO Role 3 Multinational Medical Unit (R3MMU) on Kandahar Airfield in southern Afghanistan. Preparations drew on past experience and planning. Eight complete hospital contingents were trained and deployed in rotation. Near-reality simulation training was undertaken with the combat brigade, including complete deployment of the field hospital in the exercise area. Standard operating procedures (SOP) were developed and applied by each rotation so successfully that they were adopted by the new command in late 2009. The Canadian period at R3MMU had the highest survival rate ever recorded for victims of war. Lessons learned are being applied among victims of the conflict and trauma. The experience of the R3MMU was used to successfully deploy a hospital as part of the earthquake relief effort in Haiti in 2010.The training protocols and SOP are being applied to disaster preparedness in Canadian civilian hospitals.