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Sample records for acciss study rationale

  1. ACCISS study rationale and design: activating collaborative cancer information service support for cervical cancer screening

    Bullard Emily

    2009-12-01

    Full Text Available Abstract Background High-quality cancer information resources are available but underutilized by the public. Despite greater awareness of the National Cancer Institute's Cancer Information Service among low-income African Americans and Hispanics compared with Caucasians, actual Cancer Information Service usage is lower than expected, paralleling excess cancer-related morbidity and mortality for these subgroups. The proposed research examines how to connect the Cancer Information Service to low-income African-American and Hispanic women and their health care providers. The study will examine whether targeted physician mailing to women scheduled for colposcopy to follow up an abnormal Pap test can increase calls to the Cancer Information Service, enhance appropriate medical follow-up, and improve satisfaction with provider-patient communication. Methods/Design The study will be conducted in two clinics in ethnically diverse low-income communities in Chicago. During the formative phase, patients and providers will provide input regarding materials planned for use in the experimental phase of the study. The experimental phase will use a two-group prospective randomized controlled trial design. African American and Hispanic women with an abnormal Pap test will be randomized to Usual Care (routine colposcopy reminder letter or Intervention (reminder plus provider recommendation to call the Cancer Information Service and sample questions to ask. Primary outcomes will be: 1 calls to the Cancer Information Service; 2 timely medical follow-up, operationalized by whether the patient keeps her colposcopy appointment within six months of the abnormal Pap; and 3 patient satisfaction with provider-patient communication at follow-up. Discussion The study examines the effectiveness of a feasible, sustainable, and culturally sensitive strategy to increase awareness and use of the Cancer Information Service among an underserved population. The goal of linking a

  2. Rationale and Design of the 'MITOCARE' Study

    Jensen, Svend Eggert

    2012-01-01

    Treatment of acute ST-elevation myocardial infarction (STEMI) by reperfusion using percutaneous coronary intervention (PCI) or thrombolysis has provided clinical benefits; however, it also induces considerable cell death. This process is called reperfusion injury. The continuing high rates of...... resonance). The study is being financed under an EU-FP7 grant and conducted under the auspices of the MITOCARE research consortium, which includes experts from clinical and basic research centers, as well as commercial enterprises, throughout Europe. Results from this study will contribute to a better...

  3. Design and rationale for the PREVAIL study

    Klausen, Susanne Hwiid; Mikkelsen, Ulla Ramer; Hirth, Asle;

    2012-01-01

    Intensive exercise may be an important part of rehabilitation in patients with congenital heart disease (CHD). However, performing regular physical exercise is challenging for many adolescent patients. Consequently, effective exercise encouragements may be needed. Little is known on the effect of e......:1 randomized to an intervention group or a control group. Individually fully automated tailored e-Health encouragements--SMS, Internet, and mobile applications--aimed at increasing physical activity are delivered to the participants in the intervention group once a week. The Bandura's Social Cognitive Theory......-Health encouragements on physical fitness, physical activity, and health-related quality of life in adolescents. This trial is a nationwide interactive e-Health rehabilitation study lasting 1 year, centered on interactive use of mobile phone and Internet technology. We hypothesize that e-Health encouragements and...

  4. Latin American Study of Nutrition and Health (ELANS): rationale and study design

    M. Fisberg; Kovalskys, I.; Gómez, G.; Rigotti, A; Cortés, L. Y.; Herrera-Cuenca, M.; Yépez, M. C.; Pareja, R. G.; Guajardo, V.; I.Z. Zimberg; Chiavegatto Filho, A. D. P.; Pratt, M.; Koletzko, B; Tucker, K L; ,

    2016-01-01

    Background Obesity is growing at an alarming rate in Latin America. Lifestyle behaviours such as physical activity and dietary intake have been largely associated with obesity in many countries; however studies that combine nutrition and physical activity assessment in representative samples of Latin American countries are lacking. The aim of this study is to present the design rationale of the Latin American Study of Nutrition and Health/Estudio Latinoamericano de Nutrición y Salud (ELANS) w...

  5. Rationales Shaping International Linkages in Higher Education: A Qualitative Case Study of the ASU-ITESM Strategic Alliance

    Camacho Lizarraga, Monica Irene

    2011-01-01

    This qualitative case study examines the rationales of the relationship between Arizona State University (ASU)--an American public research university--and Tecnologico de Monterrey (ITESM), a Mexican private not for profit research university. The focus of the study is to document the different meanings participants attached to the rationales of…

  6. Why look into mathematics classrooms? Rationales for comparative classroom studies in mathematics education

    Jablonka, Eva

    2015-01-01

    International audience Larger comparative studies of mathematics classrooms became most prominent as an appendix of international achievement studies. With the advance of video technology and the potentials it offers for researchers, however, comparative classroom observation studies became attractive and feasible also for smaller scale and low budget projects. This paper intends to provide a basis for discussing rationales for comparative studies of mathematics classrooms. It is suggested...

  7. The Global Enteric Multicenter Study (GEMS): Impetus, Rationale, and Genesis

    Myron M. Levine; Kotloff, Karen L.; Nataro, James P.; Muhsen, Khitam

    2012-01-01

    Diarrheal disease remains one of the top 2 causes of young child mortality in the developing world. Whereas improvements in water/sanitation infrastructure and hygiene can diminish transmission of enteric pathogens, vaccines can also hasten the decline of diarrheal disease morbidity and mortality. From 1980 through approximately 2004, various case/control and small cohort studies were undertaken to address the etiology of pediatric diarrhea in developing countries. Many studies had methodolog...

  8. The Global Enteric Multicenter Study (GEMS): impetus, rationale, and genesis.

    Levine, Myron M; Kotloff, Karen L; Nataro, James P; Muhsen, Khitam

    2012-12-01

    Diarrheal disease remains one of the top 2 causes of young child mortality in the developing world. Whereas improvements in water/sanitation infrastructure and hygiene can diminish transmission of enteric pathogens, vaccines can also hasten the decline of diarrheal disease morbidity and mortality. From 1980 through approximately 2004, various case/control and small cohort studies were undertaken to address the etiology of pediatric diarrhea in developing countries. Many studies had methodological limitations and came to divergent conclusions, making it difficult to prioritize the relative importance of different pathogens. Consequently, in the first years of the millennium there was no consensus on what diarrheal disease vaccines should be developed or implemented; however, there was consensus on the need for a well-designed study to obtain information on the etiology and burden of more severe forms of diarrheal disease to guide global investment and implementation decisions. Accordingly, the Global Enteric Multicenter Study (GEMS) was designed to overcome drawbacks of earlier studies and determine the etiology and population-based burden of pediatric diarrheal disease. GEMS, which includes one of the largest case/control studies of an infectious disease syndrome ever undertaken (target approximately 12,600 analyzable cases and 12,600 controls), was rolled out in 4 sites in sub-Saharan Africa (Gambia, Kenya, Mali, Mozambique) and 3 in South Asia (Bangladesh, India, Pakistan), with each site linked to a population under demographic surveillance (total approximately 467,000 child years of observation among children <5 years of age). GEMS data will guide investment and help prioritize strategies to mitigate the morbidity and mortality of pediatric diarrheal disease. PMID:23169934

  9. Rationales, design and recruitment for the Elfe longitudinal study

    Salines Georges

    2009-09-01

    Full Text Available Abstract Background Many factors act simultaneously in childhood to influence health status, life chances and well being, including pre-birth influences, the environmental pollutants of early life, health status but also the social influences of family and school. A cohort study is needed to disentangle these influences and explore attribution. Methods Elfe will be a nationally representative cohort of 20 000 children followed from birth to adulthood using a multidisciplinary approach. The cohort will be based on the INSEE Permanent Demographic Panel (EDP established using census data and civil records. The sample size has been defined in order to match the representativeness criteria and to obtain some prevalence estimation, but also to address the research area of low exposure/rare effects. The cohort will be based on repeated surveys by face to face or phone interview (at birth and each year as well as medical interview (at 2 years and examination (at 6 years. Furthermore, biological samples will be taken at birth to evaluate the foetal exposition to toxic substances, environmental sensors will be placed in the child's homes. Pilot studies have been initiated in 2007 (500 children with an overall acceptance rate of 55% and are currently under progress, the 2-year survey being carried out in October this year. Discussion The longitudinal study will provide a unique source of data to analyse the development of children in their environment, to study the various factors interacting throughout the life course up to adulthood and to determine the impact of childhood experience on the individual's physical, psychological, social and professional development.

  10. Rationales, design and recruitment of the Taizhou Longitudinal Study

    Lu Daru

    2009-07-01

    Full Text Available Background Rapid economic growth in China in the past decades has been accompanied by dramatic changes in lifestyle and environmental exposures. The burdens of non-communicable diseases, such as cardiovascular diseases, diabetes and cancer, have also increased substantially. Methods/design We initiated a large prospective cohort–the Taizhou Longitudinal Study–in Taizhou (a medium-size city in China to explore the environmental and genetic risk factors for common non-communicable diseases. The sample size of the cohort will be at least 100,000 adults aged 30–80 years drawn from the general residents of the districts of Hailin, Gaogang, and Taixing (sample frame, 1.8 million of Taizhou. A three-stage stratified sampling method will be applied. Baseline investigations include interviewer-administered questionnaire, anthropometric measurements, and collection of buccal mucosal cells and blood specimens. DNA will be extracted for genetic studies and serum samples will be used for biochemical examinations. A follow-up survey will be conducted every three years to obtain information on disease occurrence and information on selected lifestyle exposures. Study participants will be followed-up indefinitely by using a chronic disease register system for morbidity and cause-specific mortality. Information on non-fatal events will be obtained for certain major categories of disease (e.g., cancer, stroke, myocardial infarction through established registry systems. Discussion The Taizhou Longitudinal Study will provide a good basis for exploring the roles of many important environmental factors (especially those concomitant with the economic transformation in China for common chronic diseases, solely or via interaction with genetic factors.

  11. Targeting SRC in glioblastoma tumors and brain metastases: rationale and preclinical studies

    Ahluwalia, Manmeet; de Groot, John; Liu, Wei; Gladson, Candece L.

    2010-01-01

    Glioblastoma (GBM) is an extremely aggressive, infiltrative tumor with a poor prognosis. The regulatory approval of bevacizumab for recurrent GBM has confirmed that molecularly targeted agents have potential for GBM treatment. Preclinical data showing that SRC and SRC-family kinases (SFKs) mediate intracellular signaling pathways controlling key biologic/oncogenic processes provide a strong rationale for investigating SRC/SFK inhibitors, eg, dasatinib, in GBM and clinical studies are underway...

  12. The University of North Carolina Caries Risk Assessment Study. I: Rationale and content.

    Stamm, J W; Disney, J A; Graves, R C; Bohannan, H M; Abernathy, J R

    1988-01-01

    This article presents the rationale and content of a current study that seeks to improve methods to identify children at high risk to dental caries. It summarizes the results of the development of a 12-factor, preliminary caries prediction model based on data derived from the National Preventive Demonstration Program. Despite data limitations, the model produced a sensitivity of .5 and specificity of .8 for four-year caries increment prediction in first- and fifth-grade children. Data on a number of additional potential predictors are being collected in two sites to expand and improve the existing model. These factors are identified. PMID:3184028

  13. PET/CT-guided interventional procedures: rationale, justification, initial study, and research plan

    Positron-emission tomography (PET) and PET/CT (computed tomography) are becoming increasingly important for diagnosis and treatment of cancer. Clinically relevant changes can sometimes be seen on PET that are not seen on other imaging modalities. However, PET is not suitable for guiding biopsy as the images are not obtained in real-time. Therefore, our research group has begun developing a concept for PET/CT-guided interventional procedures. This paper presents the rationale for this concept, outlines our research plan, and includes an initial study to evaluate the relative sensitivity of CT and PET/CT in detecting suspicious lesions. (orig.)

  14. Does Design Rationale Enhance Creativity?

    Jing Wang; Umer Farooq; John M. Carroll

    2010-01-01

    Creativity and rationale are often viewed as two contrasting facets in software design. A lack in recognizing the facilitative relationship between creativity and rationale not only underestimates the benefits designers can obtain from rationale practices, but also confines the approaches that support creativity in software design. Our exploratory study provides empirical evidence of the positive correlation between rationale and creativity. Furthermore, we found that the feasibility of desig...

  15. Infant-feeding practices and American Indian infants' gut microbiome: Rationale of the pilot study.

    Zamor-Kapoor, Anna; Sinclair, Ka'imi

    2016-03-01

    This study aims to examine the relationship between infant-feeding practices and American Indian infants' gut microbiome--laying the foundation of a research program aimed at identifying potential aetiologies of childhood obesity in this population. Previous studies have emphasised the high prevalence of obesity in American Indian infants, but its underlying causes remain unclear. We received funding from the University of Washington to examine attitudes towards breastfeeding and formula feeding in American Indian mothers, their dietary and physical activity habits and the yield, quality and diversity of their infants' gut microbiome. Our study combines the strengths of qualitative and quantitative data with DNA sequencing. Results will be used to propose a larger study aimed at clarifying aetiologies of childhood obesity in this population and to identify prevention strategies. This protocol describes the theoretical basis of the study, rationale for the target population, study design, participant recruitment and data analysis plan. PMID:27188076

  16. Does Design Rationale Enhance Creativity?

    Jing Wang

    2010-01-01

    Full Text Available Creativity and rationale are often viewed as two contrasting facets in software design. A lack in recognizing the facilitative relationship between creativity and rationale not only underestimates the benefits designers can obtain from rationale practices, but also confines the approaches that support creativity in software design. Our exploratory study provides empirical evidence of the positive correlation between rationale and creativity. Furthermore, we found that the feasibility of design alternatives and the comprehensiveness of tradeoff evaluation are critical to enhancing novelty, persuasiveness, and insightfulness. We also discuss future directions to further understand how these properties, or rationale quality in general, affects design creativity.

  17. The relevance of WHO injury surveillance guidelines for evaluation: learning from the aboriginal community-centered injury surveillance system (ACCISS and two institution-based systems

    Auer Anna M

    2011-09-01

    Full Text Available Abstract Background Over the past three decades, the capacity to develop and implement injury surveillance systems (ISS has grown worldwide and is reflected by the diversity of data gathering environments in which ISS operate. The capacity to evaluate ISS, however, is less advanced and existing evaluation guidelines are ambiguous. Furthermore, the applied relevance of these guidelines to evaluate ISS operating in various settings is unclear. The aim of this paper was to examine how the World Health Organization (WHO injury surveillance guidelines have been applied to evaluate systems operating in three different contexts. Methods The attributes of a good surveillance system as well as instructions for conducting evaluations, outlined in the WHO injury surveillance guidelines, were used to develop an analytical framework. Using this framework, a comparative analysis of the application of the guidelines was conducted using; the Aboriginal Community-Centered Injury Surveillance System (ACCISS from Canada, the Shantou-Emergency Department Injury Surveillance Project (S-EDISP from China, and the Yorkhill-Canadian Hospitals Injury Reporting and Prevention Program (Y-CHIRPP imported from Canada and implemented in Scotland. Results The WHO guidelines provide only a basic platform for evaluation. The guidelines over emphasize epidemiologic attributes and methods and under emphasize public health and injury prevention perspectives requiring adaptation for context-based relevance. Evaluation elements related to the dissemination and use of knowledge, acceptability, and the sustainability of ISS are notably inadequate. From a public health perspective, alternative reference points are required for re-conceptualizing evaluation paradigms. This paper offers an ISS evaluation template that considers how the WHO guidelines could be adapted and applied. Conclusions Findings suggest that attributes of a good surveillance system, when used as evaluation metrics

  18. Male infertility after endoscopic Totally Extraperitoneal (Tep) hernia repair (Main): rationale and design of a prospective observational cohort study

    Schouten Nelleke; van Dalen Thijs; Smakman Niels; Elias Sjoerd G; van de Water Cees; Spermon Roan J; Mulder Laurens; Burgmans Ine P J

    2012-01-01

    Abstract Background To describe the rationale and design of an observational cohort study analyzing the effects of endoscopic Totally Extraperitoneal (TEP) hernia repair on male fertility (MAIN study). Methods and design The MAIN study is an observational cohort study designed to assess fertility after endoscopic TEP hernia repair. The setting is a high-volume single center hospital, specialized in TEP hernia repair. Male patients of 18-60 years of age, with primary, reducible, bilateral ingu...

  19. Rationale for an international consortium to study inherited genetic susceptibility to childhood acute lymphoblastic leukemia

    Sherborne, Amy L.; Hemminki, Kari; Kumar, Rajiv; Bartram, Claus R.; Stanulla, Martin; Schrappe, Martin; Petridou, Eleni; Semsei, Ágnes F.; Szalai, Csaba; Sinnett, Daniel; Krajinovic, Maja; Healy, Jasmine; Lanciotti, Marina; Dufour, Carlo; Indaco, Stefania; El-Ghouroury, Eman A; Sawangpanich, Ruchchadol; Hongeng, Suradej; Pakakasama, Samart; Gonzalez-Neira, Anna; Ugarte, Evelia L.; Leal, Valeria P.; Espinoza, Juan P.M.; Kamel, Azza M.; Ebid, Gamal T.A.; Radwan, Eman R.; Yalin, Serap; Yalin, Erdinc; Berkoz, Mehmet; Simpson, Jill; Roman, Eve; Lightfoot, Tracy; Hosking, Fay J.; Vijayakrishnan, Jayaram; Greaves, Mel; Houlston, Richard S.

    2011-01-01

    Acute lymphoblastic leukemia is the major pediatric cancer in developed countries. To date most association studies of acute lymphoblastic leukemia have been based on the candidate gene approach and have evaluated a restricted number of polymorphisms. Such studies have served to highlight difficulties in conducting statistically and methodologically rigorous investigations into acute lymphoblastic leukemia risk. Recent genome-wide association studies of childhood acute lymphoblastic leukemia have provided robust evidence that common variation at four genetic loci confers a modest increase in risk. The accumulated experience to date and relative lack of success of initial efforts to identify novel acute lymphoblastic leukemia predisposition loci emphasize the need for alternative study designs and methods. The International Childhood Acute Lymphoblastic Leukaemia Genetics Consortium includes 12 research groups in Europe, Asia, the Middle East and the Americas engaged in studying the genetics of acute lymphoblastic leukemia. The initial goal of this consortium is to identify and characterize low-penetrance susceptibility variants for acute lymphoblastic leukemia through association-based analyses. Efforts to develop genome-wide association studies of acute lymphoblastic leukemia, in terms of both sample size and single nucleotide polymorphism coverage, and to increase the number of single nucleotide polymorphisms taken forward to large-scale replication should lead to the identification of additional novel risk variants for acute lymphoblastic leukemia. Ethnic differences in the risk of acute lymphoblastic leukemia are well recognized and thus in assessing the interplay between inherited and non-genetic risk factors, analyses using different population cohorts with different incidence rates are likely to be highly informative. Given that the frequency of many acute lymphoblastic leukemia subgroups is small, identifying differential effects will realistically only be

  20. The Pediatric Obsessive-Compulsive Disorder Treatment Study II: rationale, design and methods

    March John S

    2009-01-01

    Full Text Available Abstract This paper presents the rationale, design, and methods of the Pediatric Obsessive-Compulsive Disorder Treatment Study II (POTS II, which investigates two different cognitive-behavior therapy (CBT augmentation approaches in children and adolescents who have experienced a partial response to pharmacotherapy with a serotonin reuptake inhibitor for OCD. The two CBT approaches test a "single doctor" versus "dual doctor" model of service delivery. A specific goal was to develop and test an easily disseminated protocol whereby child psychiatrists would provide instructions in core CBT procedures recommended for pediatric OCD (e.g., hierarchy development, in vivo exposure homework during routine medical management of OCD (I-CBT. The conventional "dual doctor" CBT protocol consists of 14 visits over 12 weeks involving: (1 psychoeducation, (2, cognitive training, (3 mapping OCD, and (4 exposure with response prevention (EX/RP. I-CBT is a 7-session version of CBT that does not include imaginal exposure or therapist-assisted EX/RP. In this study, we compared 12 weeks of medication management (MM provided by a study psychiatrist (MM only with two types of CBT augmentation: (1 the dual doctor model (MM+CBT; and (2 the single doctor model (MM+I-CBT. The design balanced elements of an efficacy study (e.g., random assignment, independent ratings with effectiveness research aims (e.g., differences in specific SRI medications, dosages, treatment providers. The study is wrapping up recruitment of 140 youth ages 7–17 with a primary diagnosis of OCD. Independent evaluators (IEs rated participants at weeks 0,4,8, and 12 during acute treatment and at 3,6, and 12 month follow-up visits. Trial registration NCT00074815

  1. The Reversal Intervention for Metabolic Syndrome (TRIMS study: rationale, design, and baseline data

    Troughton Jacqui

    2011-05-01

    Full Text Available Abstract Background Recent attention has focused on strategies to combat the forecast epidemic of type-2 diabetes (T2DM and its major vascular sequelae. Metabolic syndrome (MetS comprises a constellation of factors that increase the risk of cardiovascular disease (CVD and T2DM. Our study aims to develop a structured self-management education programme for people with MetS, which includes management of cardiovascular and diabetes risk factors, and to determine its impact. This paper describes the rationale and design of the TRIMS study, including intervention development, and presents baseline data. Methods Subjects recruited from a mixed-ethnic population with MetS were randomised to intervention or control arms. The intervention arm received structured group education based on robust psychological theories and current evidence. The control group received routine care. Follow-up data will be collected at 6 and 12 months. The primary outcome measure will be reversal of metabolic syndrome in the intervention group subjects compared to controls at 12 months follow-up. Results 82 participants (44% male, 22% South Asian were recruited between November 2009 and July 2010. Baseline characteristics were similar for both the intervention (n = 42 and control groups (n = 40. Median age was 63 years (IQR 57 - 67, mean waist size 106 cm (SD ± 11, and prescribing of statins and anti-hypertensives was 51% in each case. Conclusion Results will provide information on changes in diabetes and CVD risk factors and help to inform primary prevention strategies in people with MetS from varied ethnic backgrounds who are at high risk of developing T2DM and CVD. Information gathered in relation to the programme's acceptability and effectiveness in a multi-ethnic population would ensure that our results are widely applicable. Trial registration The study is registered at ClinicalTrials.gov, study identifier: NCT01043770.

  2. Narrative reconstruction therapy for prolonged grief disorder—rationale and case study

    Tuvia Peri

    2016-05-01

    Full Text Available Background: Prolonged grief disorder (PGD is a potentially disabling condition affecting approximately 10% of bereaved people. It has been suggested that the impaired integration of the loss memory, as expressed in recurrent memories of the loss and disorganization of memory, is involved in the development of PGD. Narrative reconstruction (NR, originally designed for the treatment of posttraumatic stress disorder (PTSD in an integrative therapy module, and consisting of exposure to the loss memory, detailed written reconstruction of the loss memory narrative and an elaboration of the personal significance of that memory for the bereaved, has been shown to be effective in the treatment of intrusion symptoms. Objective: In light of findings that cognitive behavior therapy (CBT, including cognitive restructuring and exposure, is effective in the treatment of PGD, we suggest the implementation of a somewhat novel therapy module, NR, for the treatment of intrusive phenomena in bereaved patients. Method: The rationale for the implementation of NR for PGD and a case study of the treatment of a woman suffering from PGD after the death of her father are presented. Therapy took place in a university outpatient training clinic. Results: Evaluations conducted before and after treatment and at a 3-month follow-up demonstrated the effectiveness of NR in reducing symptoms of PGD and depression. The analysis of spontaneous narratives recorded before and after treatment showed an increased organization of the narratives. Conclusions: This case report demonstrates an adaptation of NR for the treatment of PGD. The results provide preliminary support for the effectiveness of NR for PGD. The significance of the study and its limitations are discussed.

  3. Predicting asthma in preschool children with asthma symptoms: study rationale and design

    Hafkamp-de Groen Esther

    2012-10-01

    Full Text Available Abstract Background In well-child care it is difficult to determine whether preschool children with asthma symptoms actually have or will develop asthma at school age. The PIAMA (Prevention and Incidence of Asthma and Mite Allergy Risk Score has been proposed as an instrument that predicts asthma at school age, using eight easy obtainable parameters, assessed at the time of first asthma symptoms at preschool age. The aim of this study is to present the rationale and design of a study 1 to externally validate and update the PIAMA Risk Score, 2 to develop an Asthma Risk Appraisal Tool to predict asthma at school age in (specific subgroups of preschool children with asthma symptoms and 3 to test implementation of the Asthma Risk Appraisal Tool in well-child care. Methods and design The study will be performed within the framework of Generation R, a prospective multi-ethnic cohort study. In total, consent for postnatal follow-up was obtained from 7893 children, born between 2002 and 2006. At preschool age the PIAMA Risk Score will be assessed and used to predict asthma at school age. Discrimination (C-index and calibration will be assessed for the external validation. We will study whether the predictive ability of the PIAMA Risk Score can be improved by removing or adding predictors (e.g. preterm birth. The (updated PIAMA Risk Score will be converted to the Asthma Risk Appraisal Tool- to predict asthma at school age in preschool children with asthma symptoms. Additionally, we will conduct a pilot study to test implementation of the Asthma Risk Appraisal Tool in well-child care. Discussion Application of the Asthma Risk Appraisal Tool in well-child care will help to distinguish preschool children at high- and low-risk of developing asthma at school age when asthma symptoms appear. This study will increase knowledge about the validity of the PIAMA risk score and might improve risk assessment of developing asthma at school age in (specific subgroups

  4. [Venous thromboembolism's risk assessment: rationale, objectives, and methodology--the ARTE study].

    França, Ana; De Sousa, Joaquim Abreu; Felicíssimo, Paulo; Ferreira, Daniel

    2011-12-01

    ), haemorrhagic events (major and minor haemorrhages) and death at 6 months after discharge. Each patient will be contacted by telephone at 3 and 6 months after discharge, in order to assess the occurrence of thromboembolic and haemorrhagic events, as well as any readmission. This article describes the ARTE study's rationale, objectives, and methodology. PMID:22849949

  5. Prospective Study of One Million Deaths in India: Rationale, Design, and Validation Results.

    2005-12-01

    Full Text Available BACKGROUND: Over 75% of the annual estimated 9.5 million deaths in India occur in the home, and the large majority of these do not have a certified cause. India and other developing countries urgently need reliable quantification of the causes of death. They also need better epidemiological evidence about the relevance of physical (such as blood pressure and obesity, behavioral (such as smoking, alcohol, HIV-1 risk taking, and immunization history, and biological (such as blood lipids and gene polymorphisms measurements to the development of disease in individuals or disease rates in populations. We report here on the rationale, design, and implementation of the world's largest prospective study of the causes and correlates of mortality. METHODS AND FINDINGS: We will monitor nearly 14 million people in 2.4 million nationally representative Indian households (6.3 million people in 1.1 million households in the 1998-2003 sample frame and 7.6 million people in 1.3 million households in the 2004-2014 sample frame for vital status and, if dead, the causes of death through a well-validated verbal autopsy (VA instrument. About 300,000 deaths from 1998-2003 and some 700,000 deaths from 2004-2014 are expected; of these about 850,000 will be coded by two physicians to provide causes of death by gender, age, socioeconomic status, and geographical region. Pilot studies will evaluate the addition of physical and biological measurements, specifically dried blood spots. Preliminary results from over 35,000 deaths suggest that VA can ascertain the leading causes of death, reduce the misclassification of causes, and derive the probable underlying cause of death when it has not been reported. VA yields broad classification of the underlying causes in about 90% of deaths before age 70. In old age, however, the proportion of classifiable deaths is lower. By tracking underlying demographic denominators, the study permits quantification of absolute mortality rates

  6. Why do Kenyans vote along ethnic lines? : A Study of Underlying Rationales for Kenyan Electoral Behaviour

    2009-01-01

    Following the 2007 general elections Kenya plunged into a deep political, security and humanitarian crisis. The turmoil and violence that ravaged the country led to the killing of over 1,200 people and the displacement of another 350,000. The violence was undoubtedly ethnic in its character, but what about the election results and the rationales behind the electoral behaviour of the almost 10 million voters who cast their vote? The thesis looks beyond the distinctly ethnic voting patterns in ...

  7. The Strathclyde Evaluation of Children's Active Travel (SE-CAT: study rationale and methods

    McMinn David

    2011-12-01

    Full Text Available Abstract Background The school commute is a prime opportunity to increase children's physical activity levels. However, active commuting has decreased over the past 40 years. Strategies that increase walking to school are therefore needed. Travelling Green (TG is a school-based active travel resource aimed at increasing children's walking to school. The resource consists of a curriculum-based program of lessons and goal setting activities. A previous study found that children who received the TG intervention increased self-reported distance travelled to school by active modes and reduced the distance travelled by inactive modes. This study was limited by self-reported outcome measures, a small sample, and no follow-up measures. A more robust evaluation of TG is required to address these limitations. This paper describes the rationale and methods for such an evaluation of Travelling Green, and describes the piloting of various active commuting measures in primary school children. Methods/Design Measures of active commuting were piloted in a sample of 26 children (aged 8-9 years over one school week. These measures were subsequently used in an 18-month quasi-experimental design to evaluate the effect of TG on commuting behaviour. Participants were 166 children (60% male aged 8-9 years from 5 primary schools. Two schools (n = 79 children received TG in September/October 2009. Three schools (n = 87 children acted as a comparison group, and subsequently received TG at a later date. Physical activity was measured using Actigraph GT1M accelerometers. Personal and environmental determinants of active commuting were measured via parent and child questionnaires, as were factors related to the Theory of Planned Behaviour and the construct of habit. Measures were taken pre- and post-intervention and at 5 and 12 months follow-up. Discussion The piloted protocol was practical and feasible and piloted measures were reliable and valid. All study data, including

  8. Narrative reconstruction therapy for prolonged grief disorder—rationale and case study

    Peri, Tuvia; Hasson-Ohayon, Ilanit; Garber, Sharon; Tuval-Mashiach, Rivka; Boelen, Paul A.

    2016-01-01

    Background Prolonged grief disorder (PGD) is a potentially disabling condition affecting approximately 10% of bereaved people. It has been suggested that the impaired integration of the loss memory, as expressed in recurrent memories of the loss and disorganization of memory, is involved in the development of PGD. Narrative reconstruction (NR), originally designed for the treatment of posttraumatic stress disorder (PTSD) in an integrative therapy module, and consisting of exposure to the loss memory, detailed written reconstruction of the loss memory narrative and an elaboration of the personal significance of that memory for the bereaved, has been shown to be effective in the treatment of intrusion symptoms. Objective In light of findings that cognitive behavior therapy (CBT), including cognitive restructuring and exposure, is effective in the treatment of PGD, we suggest the implementation of a somewhat novel therapy module, NR, for the treatment of intrusive phenomena in bereaved patients. Method The rationale for the implementation of NR for PGD and a case study of the treatment of a woman suffering from PGD after the death of her father are presented. Therapy took place in a university outpatient training clinic. Results Evaluations conducted before and after treatment and at a 3-month follow-up demonstrated the effectiveness of NR in reducing symptoms of PGD and depression. The analysis of spontaneous narratives recorded before and after treatment showed an increased organization of the narratives. Conclusions This case report demonstrates an adaptation of NR for the treatment of PGD. The results provide preliminary support for the effectiveness of NR for PGD. The significance of the study and its limitations are discussed. Highlights of the article Prolonged grief disorder (PGD) affects approximately ten percent of bereaved people. Narrative Reconstruction (NR), an integrative therapy module originally used for PTSD patients, was adapted for PGD. NR consists

  9. Child/Adolescent Anxiety Multimodal Study (CAMS: rationale, design, and methods

    Waslick Bruce D

    2010-01-01

    Full Text Available Abstract Objective To present the design, methods, and rationale of the Child/Adolescent Anxiety Multimodal Study (CAMS, a recently completed federally-funded, multi-site, randomized placebo-controlled trial that examined the relative efficacy of cognitive-behavior therapy (CBT, sertraline (SRT, and their combination (COMB against pill placebo (PBO for the treatment of separation anxiety disorder (SAD, generalized anxiety disorder (GAD and social phobia (SoP in children and adolescents. Methods Following a brief review of the acute outcomes of the CAMS trial, as well as the psychosocial and pharmacologic treatment literature for pediatric anxiety disorders, the design and methods of the CAMS trial are described. Results CAMS was a six-year, six-site, randomized controlled trial. Four hundred eighty-eight (N = 488 children and adolescents (ages 7-17 years with DSM-IV-TR diagnoses of SAD, GAD, or SoP were randomly assigned to one of four treatment conditions: CBT, SRT, COMB, or PBO. Assessments of anxiety symptoms, safety, and functional outcomes, as well as putative mediators and moderators of treatment response were completed in a multi-measure, multi-informant fashion. Manual-based therapies, trained clinicians and independent evaluators were used to ensure treatment and assessment fidelity. A multi-layered administrative structure with representation from all sites facilitated cross-site coordination of the entire trial, study protocols and quality assurance. Conclusions CAMS offers a model for clinical trials methods applicable to psychosocial and psychopharmacological comparative treatment trials by using state-of-the-art methods and rigorous cross-site quality controls. CAMS also provided a large-scale examination of the relative and combined efficacy and safety of the best evidenced-based psychosocial (CBT and pharmacologic (SSRI treatments to date for the most commonly occurring pediatric anxiety disorders. Primary and secondary results

  10. Community Partners in Care (CPIC): Video Summary of Rationale, Study Approach / Implementation, and Client 6-month Outcomes.

    Mango, Joseph; Cabiling, Eileen; Jones, Loretta; Lucas-Wright, Aziza; Williams, Pluscedia; Wells, Kenneth; Pulido, Esmeralda; Meldrum, Marcia; Ramos, Ana; Chung, Bowen

    2014-02-25

    "Community Partners in Care (CPIC): Video Summary of Rationale, Study Approach / Implementation, and Client 6-month Outcomes" is a 2 minute, 46 second video summarizing the study rationale, study approach, and the 6-month outcomes. The video was produced by four agencies: Healthy African American Families II, a health advocacy organization in South Los Angeles; Behavioral Health Services, the largest substance/alcohol abuse service provider in LA County; UCLA; and RAND Health; contract filmmakers Eileen Cabiling and Joe Mango handled cinematography, editing, and video support. The individuals appearing in the video are key CPIC community and academic partners. The celebratory tone of the video is consistent with a Community Partnered Participatory Research approach, a local variant of participatory action research, where study findings are celebrated by the partners, and dissemination efforts include approaches intended for general audiences, especially from low-income, low-literacy, minority communities, in addition to traditional academic products like peer-reviewed scientific manuscripts. The CPIC video offers a community perspective on the study results to our partners, the general public, other scientists and policy makers. We designed the video to teach community and healthcare partners how to adapt and implement the CPIC depression care model and to offer other community -academic partnerships an example of a non-traditional product developed for dissemination from an NIH-funded research study. PMID:25364622

  11. Living with diabetes: rationale, study design and baseline characteristics for an Australian prospective cohort study

    Donald Maria

    2012-01-01

    Full Text Available Abstract Background Diabetes mellitus is a major global public health threat. In Australia, as elsewhere, it is responsible for a sizeable portion of the overall burden of disease, and significant costs. The psychological and social impact of diabetes on individuals with the disease can be severe, and if not adequately addressed, can lead to the worsening of the overall disease picture. The Living With Diabetes Study aims to contribute to a holistic understanding of the psychological and social aspects of diabetes mellitus. Methods/Design The Living With Diabetes Study is a 5-year prospective cohort study, based in Queensland, Australia. The first wave of data, which was collected via a mailed self-report survey, was gathered in 2008, with annual collections thereafter. Measurements include: demographic, lifestyle, health and disease characteristics; quality of life (EQ-5D, ADDQoL; emotional well-being (CES-D, LOT-R, ESSI; disease self-management (PAM; and health-care utilisation and patient-assessed quality of care (PACIC. 29% of the 14,439 adults who were invited to participate in the study agreed to do so, yielding a sample size of 3,951 people. Discussion The data collected by the Living With Diabetes Study provides a good representation of Australians with diabetes to follow over time in order to better understand the natural course of the illness. The study has potential to further illuminate, and give a comprehensive picture of the psychosocial implications of living with diabetes. Data collection is ongoing.

  12. Learning from failure - rationale and design for a study about discontinuation of randomized trials (DISCO study

    Kasenda Benjamin

    2012-08-01

    Full Text Available Abstract Background Randomized controlled trials (RCTs may be discontinued because of apparent harm, benefit, or futility. Other RCTs are discontinued early because of insufficient recruitment. Trial discontinuation has ethical implications, because participants consent on the premise of contributing to new medical knowledge, Research Ethics Committees (RECs spend considerable effort reviewing study protocols, and limited resources for conducting research are wasted. Currently, little is known regarding the frequency and characteristics of discontinued RCTs. Methods/Design Our aims are, first, to determine the prevalence of RCT discontinuation for specific reasons; second, to determine whether the risk of RCT discontinuation for specific reasons differs between investigator- and industry-initiated RCTs; third, to identify risk factors for RCT discontinuation due to insufficient recruitment; fourth, to determine at what stage RCTs are discontinued; and fifth, to examine the publication history of discontinued RCTs. We are currently assembling a multicenter cohort of RCTs based on protocols approved between 2000 and 2002/3 by 6 RECs in Switzerland, Germany, and Canada. We are extracting data on RCT characteristics and planned recruitment for all included protocols. Completion and publication status is determined using information from correspondence between investigators and RECs, publications identified through literature searches, or by contacting the investigators. We will use multivariable regression models to identify risk factors for trial discontinuation due to insufficient recruitment. We aim to include over 1000 RCTs of which an anticipated 150 will have been discontinued due to insufficient recruitment. Discussion Our study will provide insights into the prevalence and characteristics of RCTs that were discontinued. Effective recruitment strategies and the anticipation of problems are key issues in the planning and evaluation of trials

  13. The effects on depression of Internet-administered behavioural activation and physical exercise with treatment rationale and relapse prevention: study protocol for a randomised controlled trial

    Carlbring Per

    2013-02-01

    Full Text Available Abstract Background Despite their potential as low-threshold, low-cost and high-flexibility treatments of depression, behavioural activation and physical exercise have not yet been directly compared. This study will examine the effects of these interventions, administered via the Internet. The added effect of providing a treatment rationale will also be studied, as well as a relapse prevention program featuring cognitive behavioural therapy components. Methods/Design This randomised controlled trial will include 500 participants meeting the diagnostic criteria for major depression, recruited in multiple cycles and randomised to either a waiting list control group with delayed treatment, or one of the four treatment groups: (1 physical exercise without a clear treatment rationale; (2 physical exercise with treatment rationale; (3 behavioural activation with treatment rationale; or (4 behavioural activation without a clear treatment rationale. Post treatment, half of the participants will be offered a relapse prevention program. Primary outcome measure will be the Patient Health Questionnaire 9-item. Secondary measures include diagnostic criteria for depression, as well as self-reported anxiety, physical activity and quality of life. Measurements - done via telephone and the Internet - will be collected pre-treatment, weekly during treatment period, immediately post treatment and then monthly during a 24-month follow-up period. Discussion The results of this study will constitute an important contribution to the body of knowledge of the respective interventions. Limitations are discussed. Trial registration ClinicalTrials.gov: NCT01619930

  14. POPE study: rationale and methodology of a study to phenotype patients with COPD in Central and Eastern Europe

    Zbozinkova Z

    2016-03-01

    Full Text Available Zuzana Zbozinkova,1 Adam Barczyk,2 Ruzena Tkacova,3 Arschang Valipour,4 Neven Tudoric,5 Kirill Zykov,6 Attila Somfay,7 Marc Miravitlles,8 Vladimir Koblizek91Institute of Biostatistics and Analyses, Faculty of Medicine, Masaryk University, Brno, Czech Republic; 2Department of Pneumology, School of Medicine in Katowice, Medical University of Silesia, Katowice, Poland; 3Department of Respiratory Medicine, Faculty of Medicine, P.J. Safarik University, Kosice, Slovakia; 4Department of Respiratory and Critical Care Medicine, Ludwig-Boltzmann-Institute for COPD and Respiratory Epidemiology, Otto-Wagner-Spital, Wien, Austria; 5School of Medicine Zagreb, University Hospital Dubrava, Zagreb, Croatia; 6Laboratory of Pulmonology, Moscow State University of Medicine and Dentistry named after A.I. Evdokimov, Moscow, Russia; 7Department of Pulmonology, University of Szeged, Deszk, Hungary; 8Pneumology Department, Hospital Universitari Vall d’Hebron, CIBER de Enfermedades Respiratorias (CIBERES, Barcelona, Spain; 9Department of Pneumology, Faculty of Medicine in Hradec Kralove, University Hospital Hradec Kralove, Charles University in Prague, Hradec Kralove, Czech RepublicIntroduction: Chronic obstructive pulmonary disease (COPD constitutes a major health challenge in Central and Eastern European (CEE countries. However, clinical phenotypes, symptom load, and treatment habits of patients with COPD in CEE countries remain largely unknown. This paper provides a rationale for phenotyping COPD and describes the methodology of a large study in CEE.Methods/design: The POPE study is an international, multicenter, observational cross-sectional survey of patients with COPD in CEE. Participation in the study is offered to all consecutive outpatients with stable COPD in 84 centers across the CEE region if they fulfill the following criteria: age >40 years, smoking history ≥10 pack-years, a confirmed diagnosis of COPD with postbronchodilator FEV1/FVC ,0.7, and absence

  15. Studying the effects of classic hallucinogens in the treatment of alcoholism: rationale, methodology, and current research with psilocybin.

    Bogenschutz, Michael P

    2013-03-01

    Recent developments in the study of classic hallucinogens, combined with a re-appraisal of the older literature, have led to a renewal of interest in possible therapeutic applications for these drugs, notably their application in the treatment of addictions. This article will first provide a brief review of the research literature providing direct and indirect support for the possible therapeutic effects of classic hallucinogens such as psilocybin and lysergic acid diethylamide (LSD) in the treatment of addictions. Having provided a rationale for clinical investigation in this area, we discuss design issues in clinical trials using classic hallucinogens, some of which are unique to this class of drug. We then discuss the current status of this field of research and design considerations in future randomized trials. PMID:23627783

  16. Rationale and Methods of the Substance Use and Psychological Injury Combat Study (SUPIC): A Longitudinal Study of Army Service Members Returning from Deployment in FY2008–2011

    Larson, Mary Jo; Adams, Rachel Sayko; Mohr, Beth A.; Harris, Alex H.S.; Merrick, Elizabeth L.; Funk, Wendy; Hofmann, Keith; Wooten, Nikki R.; Jeffery, Diana D.; Williams, Thomas V.

    2013-01-01

    SUPIC will examine whether early detection and intervention for post-deployment problems among Army Active Duty and National Guard/Reservists returning from Iraq or Afghanistan are associated with improved long-term substance use and psychological outcomes. This paper describes the rationale and significance of SUPIC, and presents demographic and deployment characteristics of the study sample (N=643,205), and self-reported alcohol use and health problems from the subsample with matched post-d...

  17. Rationale, study design, and analysis plan of the Alveolar Recruitment for ARDS Trial (ART): study protocol for a randomized controlled trial

    Cavalcanti, AB; Suzumura, ÉA; Amato, MB; Tallo, FS; Rezende, AC; Telles, MM; Takahashi, LN; Carvalho, VO; Díaz-Quijano, FA; Berwanger, O; Kodama, AA; Ribeiro, GF; Abreu, MO; Oliveira, IM; Guyatt, G

    2012-01-01

    Background Acute respiratory distress syndrome (ARDS) is associated with high in-hospital mortality. Alveolar recruitment followed by ventilation at optimal titrated PEEP may reduce ventilator-induced lung injury and improve oxygenation in patients with ARDS, but the effects on mortality and other clinical outcomes remain unknown. This article reports the rationale, study design, and analysis plan of the Alveolar Recruitment for ARDS Trial (ART). Methods/Design ART is a pragmatic, multicenter...

  18. Clinicians' perceptions of rationales for rehabilitative exercise in a critical care setting: A cross-sectional study

    Nickels, M.; Aitken, L. M.; Walsham, J.; L. Watson; McPhail, S.

    2016-01-01

    Australian College of Critical Care Nurses Ltd. Background: Rehabilitative exercise for critically ill patients may have many benefits; however, it is unknown what intensive care unit (ICU) clinicians perceive to be important rationale for the implementation of rehabilitative exercise in critical care settings. Objective: To identify which rationales for rehabilitative exercise interventions were perceived by ICU clinicians to be important and determine whether perceptions were consistent acr...

  19. The intervention composed of aerobic training and non-exercise physical activity (I-CAN) study: Rationale, design and methods.

    Swift, Damon L; Dover, Sara E; Nevels, Tyara R; Solar, Chelsey A; Brophy, Patricia M; Hall, Tyler R; Houmard, Joseph A; Lutes, Lesley D

    2015-11-01

    Recent data has suggested that prolonged sedentary behavior is independent risk factor for cardiovascular and all-cause mortality independent of adequate amounts of moderate to vigorous physical activity. However, few studies have prospectively evaluated if exercise training and increasing non-exercise physical activity leads to greater reduction in cardiometabolic risk compared to aerobic training alone. The purpose of the Intervention Composed of Aerobic Training and Non-Exercise Physical Activity (I-CAN) study is to determine whether a physical activity program composed of both aerobic training (consistent with public health recommendations) and increasing non-exercise physical activity (3000 steps above baseline levels) leads to enhanced improvements in waist circumference, oral glucose tolerance, systemic inflammation, body composition, and fitness compared to aerobic training alone in obese adults (N=45). Commercially available accelerometers (Fitbits) will be used to monitor physical activity levels and behavioral coaching will be used to develop strategies of how to increase non-exercise physical activity levels. In this manuscript, we describe the design, rationale, and methodology associated with the I-CAN study. PMID:26542389

  20. Skirting around Critical Feminist Rationales for Teaching Women in Social Studies

    Schmeichel, Mardi

    2015-01-01

    Feminist practices can provide firm theoretical grounding for the kind of social studies that scholars promote, especially in relation to efforts to include women in the curriculum. However, in P-12 social studies education, neither women nor feminism receive much attention. The study described in this article was a discourse analysis of 16…

  1. Dose timing of D-cycloserine to augment cognitive behavioral therapy for social anxiety: Study design and rationale.

    Hofmann, Stefan G; Carpenter, Joseph K; Otto, Michael W; Rosenfield, David; Smits, Jasper A J; Pollack, Mark H

    2015-07-01

    The use of D-cycloserine (DCS) as a cognitive enhancer to augment exposure-based cognitive-behavioral therapy (CBT) represents a promising new translational research direction with the goal to accelerate and optimize treatment response for anxiety disorders. Some studies suggest that DCS may not only augment extinction learning but could also facilitate fear memory reconsolidation. Therefore, the effect of DCS may depend on fear levels reported at the end of exposure sessions. This paper presents the rationale and design for a randomized controlled trial examining the relative efficacy of tailoring DCS administration based on exposure success (i.e. end fear levels) during a 5-session group CBT protocol for social anxiety disorder (n = 156). Specifically, tailored post-session DCS administration will be compared against untailored post-session DCS, untailored pre-session DCS, and pill placebo in terms of reduction in social anxiety symptoms and responder status. In addition, a subset of participants (n = 96) will undergo a fear extinction retention experiment prior to the clinical trial in which they will be randomly assigned to receive either DCS or placebo prior to extinguishing a conditioned fear. The results from this experimental paradigm will clarify the mechanism of the effects of DCS on exposure procedures. This study aims to serve as the first step toward developing an algorithm for the personalized use of DCS during CBT for social anxiety disorder, with the ultimate goal of optimizing treatment outcome for anxiety disorders. PMID:26111923

  2. European Prospective Investigation into Cancer and Nutrition (EPIC) calibration study: rationale, design and population characteristics

    Slimani, N.; Kaaks, R.; Ferrari, P.;

    2002-01-01

    a large multi-centre European study. These studies showed that, despite certain inherent methodological and logistic constraints, a study design such as this one works relatively well in practice. The average response in the calibration study was 78.3% and ranged from 46.5% to 92.5%. The calibration...... population differed slightly from the overall cohort but the differences were small for most characteristics and centres. The overall results suggest that, after adjustment for age, dietary intakes estimated from calibration samples can reasonably be interpreted as representative of the main cohorts in most...

  3. A Birth Cohort Study: Conceptual and Design Considerations and Rationale. Working Paper Series.

    Moore, Kristin; Manlove, Jennifer; Richter, Kerry; Halle, Tamara; Le Menestrel, Suzanne; Zaslow, Martha; Greene, Angela Dungee; Mariner, Carrie; Romano, Angela; Bridges, Lisa

    The Early Childhood Longitudinal Study, Birth Cohort 2000 (ECLS-B) is a study that will assess children's health status and their growth and development in domains that are critical for later school readiness and academic achievement. This paper is one of several that have been prepared in support of ECLS-B design efforts. It is anticipated that…

  4. The Alberta Pregnancy Outcomes and Nutrition (APrON) cohort study : rationale and methods

    Kaplan, Bonnie J.; Giesbrecht, Gerald F.; Leung, Brenda M. Y.; Field, Catherine J.; Dewey, Deborah; Bell, Rhonda C.; Manca, Donna P.; O'Beirne, Maeve; Johnston, David W.; Pop, Victor J.; Singhal, Nalini; Gagnon, Lisa; Bernier, Francois P.; Eliasziw, Misha; McCargar, Linda J.; Kooistra, Libbe; Farmer, Anna; Cantell, Marja; Goonewardene, Laki; Casey, Linda M.; Letourneau, Nicole; Martin, Jonathan W.

    2014-01-01

    The Alberta Pregnancy Outcomes and Nutrition (APrON) study is an ongoing prospective cohort study that recruits pregnant women early in pregnancy and, as of 2012, is following up their infants to 3 years of age. It has currently enrolled approximately 5000 Canadians (2000 pregnant women, their offsp

  5. The Netherlands Study of Depression and Anxiety (NESDA): rationale, objectives and methods

    Penninx, B.W.J.H.; Beekman, A.T.F.; Smit, J.H; Zitman, F.G.; Nolen, W.A.; Spinhoven, P; Cuijpers, P.; De Jong, P.J.; Van Marwijk, H.W.J.; Assendelft, W.J.J.; Van Der Meer, K.; Verhaak, P.; Wensing, M.; de Graaf, R.; Hoogendijk, W.J.; Ormel, J.; Van Dyck, R.

    2008-01-01

    The Netherlands Study of Depression and Anxiety (NESDA) is a multi-site naturalistic cohort study to: (1) describe the long-term course and consequences of depressive and anxiety disorders, and (2) to integrate biological and psychosocial research paradigms within an epidemiological approach in orde

  6. The Netherlands Study of Depression and Anxiety (NESDA) : rationale, objectives and methods

    Penninx, B.W.J.H.; Beekman, A.T.F.; Smit, J.H.; Zitman, F.G.; Nolen, W.A.; Spinhoven, P.; Cuijpers, P.; de Jong, P.J.; Van Marwijk, H.W.J.; Assendelft, W.J.J.; van der Meer, K.; Verhaak, P.; Wensing, M.; de Graaf, R.; Hoogendijk, W.J.; Ormel, J.; Van Dyck, R.

    2008-01-01

    The Netherlands Study of Depression and Anxiety (NESDA) is a multi-site naturalistic cohort study to: (1) describe the long-term course and consequences of depressive and anxiety disorders, and (2) to integrate biological and psychosocial research paradigms within an epidemiological approach in orde

  7. Rationale and conditions for the requirement of chiral bioanalytical methods in bioequivalence studies

    Torrado, Juan José; Blanco, María; Farré, Magí; Roset, Pere; García-Arieta, Alfredo

    2010-01-01

    Abstract Purpose The aim of the present work was to assess the need for chiral bioanalytical methods in bioequivalence studies. Methods The samples from a bioequivalence study of two ibuprofen 2% oral suspensions that had shown bioequivalence for AUC and Cmax, but not for tmax (medians of 2.0 and 0.75 h) with a non-chiral method were assayed with a chiral method to investigate whether there was an actual d...

  8. Design, rationale, and baseline characteristics of a cluster randomized controlled trial of pay for performance for hypertension treatment: study protocol

    Lutschg Meghan Z

    2011-10-01

    Full Text Available Abstract Background Despite compelling evidence of the benefits of treatment and well-accepted guidelines for treatment, hypertension is controlled in less than one-half of United States citizens. Methods/design This randomized controlled trial tests whether explicit financial incentives promote the translation of guideline-recommended care for hypertension into clinical practice and improve blood pressure (BP control in the primary care setting. Using constrained randomization, we assigned 12 Veterans Affairs hospital outpatient clinics to four study arms: physician-level incentive; group-level incentive; combination of physician and group incentives; and no incentives (control. All participants at the hospital (cluster were assigned to the same study arm. We enrolled 83 full-time primary care physicians and 42 non-physician personnel. The intervention consisted of an educational session about guideline-recommended care for hypertension, five audit and feedback reports, and five disbursements of incentive payments. Incentive payments rewarded participants for chart-documented use of guideline-recommended antihypertensive medications, BP control, and appropriate responses to uncontrolled BP during a prior four-month performance period over the 20-month intervention. To identify potential unintended consequences of the incentives, the study team interviewed study participants, as well as non-participant primary care personnel and leadership at study sites. Chart reviews included data collection on quality measures not related to hypertension. To evaluate the persistence of the effect of the incentives, the study design includes a washout period. Discussion We briefly describe the rationale for the interventions being studied, as well as the major design choices. Rigorous research designs such as the one described here are necessary to determine whether performance-based payment arrangements such as financial incentives result in meaningful

  9. Learning environments’ activity potential for preschoolers (LEAPP: study rationale and design

    Patricia Tucker

    2013-09-01

    Full Text Available Background. The purpose of this paper is to provide an overview of the study protocol for the Learning Environments’ Activity Potential for Preschoolers (LEAPP study, the goal of which is to describe the activity levels of preschoolers attending various early learning venues and explore which attributes of these facilities (e.g. curriculum, policies, equipment, etc. support activity participation.Design and Methods. This cross-sectional study aimed to recruit approximately 30 early learning environments requesting participation from preschoolers aged 2.5-5 years. Data collection included: Actical accelerometers (MiniMitter, Oregon, USA to measure the activity levels of children for five consecutive days (15-second epoch length while in care; the Environment and Policy Assessment and Observation tool to explore the early learning environment’s impact on activity; anthropometric data; the Child Temperament Questionnaire to assess the influence of preschoolers’ temperament on physical activity; and demographic information from parents/guardians and early learning staff. ANOVA and linear regression analyses will be conducted to assess variances in activity levels among preschoolers attending different early learning types and to explore the impact of early learning environments on their activity levels. Independent sample t-tests will be used to examine differences in activity levels based on sex and weight status.Expected impact of the study for public health. This research will provide the first Canadian data to address environmental influences on preschoolers’ activity levels in differing early learning environments. Additionally, this work will highlight the extent to which activity levels vary among preschoolers enrolled in full-day kindergarten, centre-, and home-based childcare.

  10. Better exercise adherence after treatment for cancer (BEAT Cancer) study: Rationale, design, and methods

    Rogers, Laura Q; McAuley, Edward; Anton, Philip M.; Courneya, Kerry S; Vicari, Sandra; Hopkins-Price, Patricia; Verhulst, Steven; Mocharnuk, Robert; Hoelzer, Karen

    2011-01-01

    Most breast cancer survivors do not engage in regular physical activity. Our physical activity behavior change intervention for breast cancer survivors significantly improved physical activity and health outcomes post-intervention during a pilot, feasibility study. Testing in additional sites with a larger sample and longer follow-up is warranted to confirm program effectiveness short and longer term. Importantly, the pilot intervention resulted in changes in physical activity and social cogn...

  11. The Strathclyde Evaluation of Children's Active Travel (SE-CAT): study rationale and methods

    McMinn David; Rowe David A; Murtagh Shemane; Nelson Norah M

    2011-01-01

    Abstract Background The school commute is a prime opportunity to increase children's physical activity levels. However, active commuting has decreased over the past 40 years. Strategies that increase walking to school are therefore needed. Travelling Green (TG) is a school-based active travel resource aimed at increasing children's walking to school. The resource consists of a curriculum-based program of lessons and goal setting activities. A previous study found that children who received th...

  12. Children, parents, and pets exercising together (CPET randomised controlled trial: study rationale, design, and methods

    Yam Philippa S

    2012-03-01

    Full Text Available Abstract Background Objectively measured physical activity is low in British children, and declines as childhood progresses. Observational studies suggest that dog-walking might be a useful approach to physical activity promotion in children and adults, but there are no published public health interventions based on dog-walking with children. The Children, Parents, and Pets Exercising Together Study aims to develop and evaluate a theory driven, generalisable, family-based, dog walking intervention for 9-11 year olds. Methods/design The Children, Parents, and Pets Exercising Together Study is an exploratory, assessor-blinded, randomised controlled trial as defined in the UK MRC Framework on the development and evaluation of complex interventions in public health. The trial will follow CONSORT guidance. Approximately 40 dog-owning families will be allocated randomly in a ratio of 1.5:1 to receive a simple behavioural intervention lasting for 10 weeks or to a 'waiting list' control group. The primary outcome is change in objectively measured child physical activity using Actigraph accelerometry. Secondary outcomes in the child, included in part to shape a future more definitive randomised controlled trial, are: total time spent sedentary and patterning of sedentary behaviour (Actigraph accelerometry; body composition and bone health from dual energy x-ray absorptiometry; body weight, height and BMI; and finally, health-related quality of life using the PedsQL. Secondary outcomes in parents and dogs are: changes in body weight; changes in Actigraph accelerometry measured physical activity and sedentary behaviour. Process evaluation will consist of assessment of simultaneous child, parent, and dog accelerometry data and brief interviews with participating families. Discussion The Children, Parents, and Pets Exercising Together trial should be the first randomised controlled study to establish and evaluate an intervention aimed at dog-based physical

  13. Prevalence of Work-Related Asthma in Primary Health Care: Study Rationale and Design

    Rabell-Santacana, Ventura; Panadès-Valls, Rafael; Vila-Rigat, Rosa; Hernandez-Huet, Enric; Sivecas-Maristany, Joan; Blanché-Prat, Xavier; Prieto, Gemma; Muñoz, Laura; Torán, Pere

    2015-01-01

    Background : Occupational Asthma (OA) is the most frequent origin of occupational respiratory diseases in industrialized countries and accounts for between 5% and 25% of asthmatic patients. The correct and early diagnosis of OA is of great preventive and socio-economic importance. However, few studies exist on OA’s prevalence in Catalonia and in Spain and those affected are mainly treated by the public health services and not by the occupational health services, which are private. Objective : To determine the prevalence of OA in patients diagnosed with asthma in the Primary Healthcare system and to evaluate the socio-economic impact of OA in the Primary Healthcare system. Methods/Design : We will carry out an observational, transversal and multi-center study in the Primary Healthcare Service in the Barcelona region (Catalonia, Spain), with 385 asthmatic workers aged between 16 and 64 who are currently working or have been working in the past. We will confirm the asthma diagnosis in each patient, and those meeting the inclusion criteria will be asked to answer a questionnaire that aims to link asthma to the patient’s past employment history. The resulting diagnosis will be of either occupational asthma, work-aggravated asthma or common asthma. We will also collect socio-demographic information about the patients, about their smoking status, their exposure outside of the workplace, their work situation at the onset of the symptoms, their employment history, their symptoms of asthma, their present and past medical asthma treatment, and, in order to estimate the economic impact in the Primary Healthcare system, where they have been attended to and treated. Prevalence will link OA or work-aggravated asthma to the total of patients participating in the study with a asthma diagnosis. Discussion : The results will show the prevalence of OA and work-aggravated asthma, and shall provide valuable information to set out and apply the necessary personal and technical

  14. The health outcomes and physical activity in preschoolers (HOPP study: rationale and design

    Timmons Brian W

    2012-04-01

    Full Text Available Abstract Background The early years are the period of growth for which we know the least about the impact of physical activity. In contrast, we know that more than 90 % of school-aged Canadian children, for example, are not meeting physical activity recommendations. Such an activity crisis is a major contributor to recent trends in childhood obesity, to which preschoolers are not immune. The World Health Organization estimated that more than 42 million children under the age of 5 years were overweight world-wide in 2010. If an activity crisis exists during the preschool years, we should also be concerned about its broader impact on health. Unfortunately, the relationship between physical activity and health during the early years is poorly understood. The goal of the Health Outcomes and Physical activity in Preschoolers (HOPP study is to describe how the prevalence and patterns of physical activity in preschoolers are associated with indices of health. Methods The HOPP study is a prospective cohort study. We aim to recruit 400 3- to 5-year-old children (equal number of boys and girls and test them once per year for 3 years. Each annual assessment involves 2 laboratory visits and 7 consecutive days of physical activity monitoring with protocols developed in our pilot work. At visit 1, we assess body composition, aerobic fitness, short-term muscle power, motor skills, and have the parents complete a series of questionnaires related to their child’s physical activity, health-related quality of life and general behaviour. Over 7 consecutive days each child wears an accelerometer on his/her waist to objectively monitor physical activity. The accelerometer is programmed to record movement every 3 s, which is needed to accurately capture the intensity of physical activity. At visit 2, we assess vascular structure and function using ultrasound. To assess the associations between physical activity and health outcomes, our primary analysis will involve

  15. Rationale and design of INTERSTROKE: a global case-control study of risk factors for stroke

    O'Donnell, M; Serpault, Damien Xavier; Diener, C;

    2010-01-01

    population-attributable risk. However, traditional risk factors (e.g. hypertension, cholesterol) appear to exert contrasting risks for stroke compared with coronary heart disease, and the etiology of stroke is far more heterogeneous. In addition, our knowledge of risk factors for stroke in low...... with a first stroke within 72 h of hospital presentation in whom CT or MRI is performed. Proxy respondents are used for cases unable to communicate. Etiological and topographical stroke subtype is documented for all cases. Controls are hospital- and community-based, matched for gender, ethnicity and...... urine samples are obtained from cases and controls. Study Significance: An effective global strategy to reduce the risk of stroke mandates systematic measurement of the contribution of the major vascular risk factors within defined ethnic groups and geographical locations....

  16. Aliskiren Trial in Type 2 Diabetes Using Cardio-Renal Endpoints (ALTITUDE): rationale and study design

    Parving, Hans-Henrik; Brenner, Barry M; McMurray, John J V; de Zeeuw, Dick; Haffner, Steven M; Solomon, Scott D; Chaturvedi, Nish; Ghadanfar, Mathieu; Weissbach, Nicole; Xiang, Zhihua; Armbrecht, Juergen; Pfeffer, Marc A

    2009-01-01

    , resuscitated death, myocardial infarction, stroke, unplanned hospitalization for heart failure, onset of end-stage renal disease or doubling of baseline serum creatinine concentration. Secondary endpoints include a composite CV endpoint and a composite renal endpoint. CONCLUSION: ALTITUDE will determine...... residual renal and cardiovascular risk still remains high. Aliskiren a novel oral direct renin inhibitor that unlike ACEi and ARBs, lowers plasma renin activity, angiotensin I and angiotensin II levels, may thereby provide greater benefit compared to ACEi or ARB alone. METHODS: The primary objective of the...... ALTITUDE trial is to determine whether aliskiren 300 mg once daily, reduces cardiovascular and renal morbidity and mortality compared with placebo when added to conventional treatment (including ACEi or ARB). ALTITUDE is an international, randomized, double-blind, placebo-controlled, parallel-group study...

  17. Rationale and design of South Asian Birth Cohort (START: a Canada-India collaborative study

    Anand Sonia S

    2013-01-01

    Full Text Available Abstract Background People who originate from the Indian subcontinent (South Asians suffer among the highest rates of type 2 diabetes in the world. Prior evidence suggests that metabolic risk factors develop early in life and are influenced by maternal and paternal behaviors, the intrauterine environment, and genetic factors. The South Asian Birth Cohort Study (START will investigate the environmental and genetic basis of adiposity among 750 South Asian offspring recruited from highly divergent environments, namely, rural and urban India and urban Canada. Methods Detailed information on health behaviors including diet and physical activity, and blood samples for metabolic parameters and DNA are collected from pregnant women of South Asian ancestry who are free of significant chronic disease. They also undergo a provocative test to diagnose impaired glucose tolerance and gestational diabetes. At delivery, cord blood and newborn anthropometric indices (i.e. birth weight, length, head circumference and skin fold thickness are collected. The mother and growing offspring are followed prospectively and information on the growth trajectory, adiposity and health behaviors will be collected annually up to age 3 years. Our aim is to recruit a minimum of 750 mother-infant pairs equally divided between three divergent environments: rural India, urban India, and Canada. Summary The START cohort will increase our understanding of the environmental and genetic determinants of adiposity and related metabolic abnormalities among South Asians living in India and Canada.

  18. Rationale and design of the EXenatide Study of Cardiovascular Event Lowering (EXSCEL) trial.

    Holman, Rury R; Bethel, Mary Angelyn; George, Jyothis; Sourij, Harald; Doran, Zoë; Keenan, Joanne; Khurmi, Nardev S; Mentz, Robert J; Oulhaj, Abderrahim; Buse, John B; Chan, Juliana C; Iqbal, Nayyar; Kundu, Sudeep; Maggioni, Aldo P; Marso, Steven P; Öhman, Peter; Pencina, Michael J; Poulter, Neil; Porter, Lisa E; Ramachandran, Ambady; Zinman, Bernard; Hernandez, Adrian F

    2016-04-01

    Exenatide once-weekly is an extended release formulation of exenatide, a glucagon-like peptide-1 receptor agonist, which can improve glycemic control, body weight, blood pressure, and lipid levels in patients with type 2 diabetes mellitus (T2DM). The EXenatide Study of Cardiovascular Event Lowering (EXSCEL) will compare the impact of adding exenatide once-weekly to usual care with usual care alone on major cardiovascular outcomes. EXSCEL is an academically led, phase III/IV, double-blind, pragmatic placebo-controlled, global trial conducted in 35 countries aiming to enrol 14,000 patients with T2DM and a broad range of cardiovascular risk over approximately 5 years. Participants will be randomized (1:1) to receive exenatide once-weekly 2 mg or matching placebo by subcutaneous injections. The trial will continue until 1,360 confirmed primary composite cardiovascular end points, defined as cardiovascular death, nonfatal myocardial infarction, or nonfatal stroke, have occurred. The primary efficacy hypothesis is that exenatide once-weekly is superior to usual care with respect to the primary composite cardiovascular end point. EXSCEL is powered to detect a 15% relative risk reduction in the exenatide once-weekly group, with 85% power and a 2-sided 5% alpha. The primary safety hypothesis is that exenatide once-weekly is noninferior to usual care with respect to the primary cardiovascular composite end point. Noninferiority will be concluded if the upper limit of the CI is <1.30. EXSCEL will assess whether exenatide once-weekly can reduce cardiovascular events in patients with T2DM with a broad range of cardiovascular risk. It will also provide long-term safety information on exenatide once-weekly in people with T2DM. ClinicalTrials.gov Identifier: NCT01144338. PMID:26995376

  19. Study design, objectives, hypotheses, main findings, health consequences for the population exposed, rationale of future research

    Trnovec, T.; Kocan, A. [Slovak Medical Univ., Bratislava (Slovakia); Bencko, V. [Charles Univ., Prague (Czech Republic); Langer, P. [Institute of Experimental Endocrinology SAS, Bratislava (Slovakia); Berg, M. van den [Rijksuniversiteit Utrecht (Netherlands); Bergman, A. [Stockholm Univ. (Sweden); Hustak, M. [Air Force Military Hospital, Kosics (Slovakia)

    2004-09-15

    In Slovakia, the Chemko Chemical Company, based in Strazske, in the Michalovce district, produced PCBs between 1959 and 1984, in the amount of more than 21,000 tons of commercial mixtures (Delor 103, 104, 105, 106, Delotherm DK and DH, Hydelor 137). PCBs were used for similar industrial purposes as in the west. Improper disposal from the Chemko plant via release of effluent directly into the Laborec River resulted in long-term contamination of sediment. As a result eastern Slovakia, the Michalovce district in particular, is recognized as one of the areas all over the world most heavily polluted with PCBs. Historical studies show that blood and adipose PCB levels were higher in Czechoslovakia than elsewhere in the 1970's and 1980's. Current data indicate that persons who eat locally raised food - pork, beef, poultry, eggs - in this district have elevated serum concentrations of PCBs. Environmental exposure to organochlorines in the Michalovce district indicate association with higher rates of certain cancers, but an inverse association with risk of breast cancer. An increased prevalence of thyroid disorders in the polluted area was also reported. This ''experimental setting in nature'' has attracted international scientific teams and two projects in the area are ongoing: Evaluating Human Health Risk from Low-dose and Long-term PCB Exposure, 5{sup th} FP Project QLK4-2000-00488, 2001- 2004; PCBRISK (http://www.pcbrisk.sk/) and Early Childhood Development and PCB Exposures in Slovakia, NCI/NIH, R01-CA96525 University of California, Davis, USA. This paper is serving as an introduction to papers of a session reporting on various health outcomes associated with PCB exposure. The objectives of the PCBRISK project were targeted at an evaluation of the human health risks of low-dose and long-term exposure to a group of persistent organochlorine pollutants, including polychlorinated biphenyls (PCBs) and their metabolites, organochlorine

  20. The New Social Studies for the Slow Learner: A Rationale for a Junior High American History Course.

    Blackwell, Velvelyn; And Others

    This is a curriculum rationale developed as a preliminary to the development and testing of curricular materials in the slow learner classroom situation. Chapter one disucsses individual characteristics and a definition of a slow learner. The remainder of the report analyzes approaches to teaching, taking into consideration these characteristics.…

  1. Danish pain specialists' rationales behind the choice of fentanyl transdermal patches and oral transmucosal systems-A Delphi study

    Jacobsen, Ramune; Møldrup, Claus; Christrup, Lona

    2009-01-01

    survey. Response rates were 45% in the brainstorming and 88% in the rating phases, respectively. Statistical analysis with SPSS for Windows 15.00 included descriptive statistics and factor analysis. Results. The most important rationale to choose fentanyl patches was that patients' clinical condition did...

  2. Male infertility after endoscopic Totally Extraperitoneal (Tep hernia repair (Main: rationale and design of a prospective observational cohort study

    Schouten Nelleke

    2012-05-01

    Full Text Available Abstract Background To describe the rationale and design of an observational cohort study analyzing the effects of endoscopic Totally Extraperitoneal (TEP hernia repair on male fertility (MAIN study. Methods and design The MAIN study is an observational cohort study designed to assess fertility after endoscopic TEP hernia repair. The setting is a high-volume single center hospital, specialized in TEP hernia repair. Male patients of 18-60 years of age, with primary, reducible, bilateral inguinal hernias and no contraindications for endoscopic TEP repair are eligible for inclusion in this study. Patients with an ASA-classification ≥ III and patients with recurrent and/or scrotal hernias and/or a medical history of pelvic surgery and/or radiotherapy, known fertility problems, diabetes and/or other diseases associated with a risk of fertility problems, will be excluded. The primary outcome is the testicular perfusion before and 6 months after TEP hernia repair (assessed by means of a scrotal ultrasonography. Secondary endpoints are the testicular volume (Ultrasound, semen quality and quantity and the endocrinological status, based on serum levels of the sexual hormones follicle-stimulating hormone (FSH, luteinizing hormone (LSH, testosterone and inhibin B before and 6 months after TEP hernia repair. Discussion The use of polypropylene mesh is associated with a strong foreign body reaction which could play a role in chronic groin pain development. Since the mesh in (endoscopic inguinal hernia repair is placed in close contact to the vas deferens and spermatic vessels, the mesh-induced inflammatory reaction could lead to a dysfunction of these structures. Relevant large and prospective clinical studies on the problem are limited. This study will provide a complete assessment of fertility in male patients who undergo simultaneous bilateral endoscopic TEP hernia repair, by analyzing testicular perfusion and volume, semen quantity and quality

  3. Aspirin for the prevention of cognitive decline in the elderly: rationale and design of a neuro-vascular imaging study (ENVIS-ion)

    Reid Christopher M; Storey Elsdon; Wong Tien Y; Woods Robyn; Tonkin Andrew; Wang Jie; Kam Anthony; Janke Andrew; Essex Rowan; Abhayaratna Walter P; Budge Marc M

    2012-01-01

    Abstract Background This paper describes the rationale and design of the ENVIS-ion Study, which aims to determine whether low-dose aspirin reduces the development of white matter hyper-intense (WMH) lesions and silent brain infarction (SBI). Additional aims include determining whether a) changes in retinal vascular imaging (RVI) parameters parallel changes in brain magnetic resonance imaging (MRI); b) changes in RVI parameters are observed with aspirin therapy; c) baseline cognitive function ...

  4. The Nutrition and Enjoyable Activity for Teen Girls (NEAT girls) randomized controlled trial for adolescent girls from disadvantaged secondary schools: rationale, study protocol, and baseline results

    Okely Anthony D; Plotnikoff Ronald C; Collins Clare E; Dewar Deborah; Morgan Philip J; Lubans David R; Batterham Marijka J; Finn Tara; Callister Robin

    2010-01-01

    Abstract Background Child and adolescent obesity predisposes individuals to an increased risk of morbidity and mortality from a range of lifestyle diseases. Although there is some evidence to suggest that rates of pediatric obesity have leveled off in recent years, this has not been the case among youth from low socioeconomic backgrounds. The purpose of this paper is to report the rationale, study design and baseline findings of a school-based obesity prevention program for low-active adolesc...

  5. The development of criteria for limiting the non-uniform irradiation of skin: the rationale for a study of non-stochastic effects

    Recent recommendations of the ICRP (1977) provide little guidance for the treatment of non-uniform skin exposures such as those which may occur as the result of contamination with radioactive particulates. This lack of guidance is due to a paucity of data regarding biological effects in this area. A rationale is presented for the study of the early (non-stochastic) effects of non-uniform skin irradiation. As a basis for the presentation of this rationale a framework is provided by a resume of basic biology of the skin and a review of previous experimental work in this field. Animal experiments, which are being carried out in collaboration with specialist university groups, are described both in terms of broad concept and experimental detail. The aim is to provide biological data which can provide guidance in radiological protection situations. (author)

  6. Causes and consequences of cerebral small vessel disease. The RUN DMC study: a prospective cohort study. Study rationale and protocol

    van der Vlugt Maureen J

    2011-02-01

    Full Text Available Abstract Background Cerebral small vessel disease (SVD is a frequent finding on CT and MRI scans of elderly people and is related to vascular risk factors and cognitive and motor impairment, ultimately leading to dementia or parkinsonism in some. In general, the relations are weak, and not all subjects with SVD become demented or get parkinsonism. This might be explained by the diversity of underlying pathology of both white matter lesions (WML and the normal appearing white matter (NAWM. Both cannot be properly appreciated with conventional MRI. Diffusion tensor imaging (DTI provides alternative information on microstructural white matter integrity. The association between SVD, its microstructural integrity, and incident dementia and parkinsonism has never been investigated. Methods/Design The RUN DMC study is a prospective cohort study on the risk factors and cognitive and motor consequences of brain changes among 503 non-demented elderly, aged between 50-85 years, with cerebral SVD. First follow up is being prepared for July 2011. Participants alive will be included and invited to the research centre to undergo a structured questionnaire on demographics and vascular risk factors, and a cognitive, and motor, assessment, followed by a MRI protocol including conventional MRI, DTI and resting state fMRI. Discussion The follow up of the RUN DMC study has the potential to further unravel the causes and possibly better predict the consequences of changes in white matter integrity in elderly with SVD by using relatively new imaging techniques. When proven, these changes might function as a surrogate endpoint for cognitive and motor function in future therapeutic trials. Our data could furthermore provide a better understanding of the pathophysiology of cognitive and motor disturbances in elderly with SVD. The execution and completion of the follow up of our study might ultimately unravel the role of SVD on the microstructural integrity of the white

  7. Retrievability; rationale, measures, impacts

    The concept of deep geological disposal was developed in order to permanently remove radioactive wastes from the human environment. Retrieval of wastes was reckoned to be a scenario of such low probability that little effort was initially devoted to its study. In recent years, however, there has been an increasingly active debate on whether fully passive (and safe) systems provide a sufficient level of practicability of retrievability. This debate is linked directly to practical, technical matters, such as the design of the facility, the operating procedures and also the institutional programs throughout the lifetime of a repository. But there are also philosophical issues involved in addition to these purely technical issues. For retrievability, the questions are: How easy does retrieval have to be in the different stages of repository development? What is the rationale for requiring retrievability? What technical measures and methods are feasible? Should specific features facilitating retrievability be introduced into the repository design? How do such measures impact on other aspects of system performance and on other issues (such as safeguards)? This paper addresses the questions raised and presents a subjective set of conclusions, as a means to stimulate further debate on this topical issue. Copyright (2001) Material Research Society

  8. Hanford waste-form release and sediment interaction: A status report with rationale and recommendations for additional studies

    Serne, R.J. (Pacific Northwest Lab., Richland, WA (USA)); Wood, M.I. (Westinghouse Hanford Co., Richland, WA (USA))

    1990-05-01

    This report documents the currently available geochemical data base for release and retardation for actual Hanford Site materials (wastes and/or sediments). The report also recommends specific laboratory tests and presents the rationale for the recommendations. The purpose of this document is threefold: to summarize currently available information, to provide a strategy for generating additional data, and to provide recommendations on specific data collection methods and tests matrices. This report outlines a data collection approach that relies on feedback from performance analyses to ascertain when adequate data have been collected. The data collection scheme emphasizes laboratory testing based on empiricism. 196 refs., 4 figs., 36 tabs.

  9. Hanford waste-form release and sediment interaction: A status report with rationale and recommendations for additional studies

    This report documents the currently available geochemical data base for release and retardation for actual Hanford Site materials (wastes and/or sediments). The report also recommends specific laboratory tests and presents the rationale for the recommendations. The purpose of this document is threefold: to summarize currently available information, to provide a strategy for generating additional data, and to provide recommendations on specific data collection methods and tests matrices. This report outlines a data collection approach that relies on feedback from performance analyses to ascertain when adequate data have been collected. The data collection scheme emphasizes laboratory testing based on empiricism. 196 refs., 4 figs., 36 tabs

  10. Rationale and design of the plate or pin (pop study for dislocated midshaft clavicular fractures: study protocol for a randomised controlled trial

    Meylaerts Sven AG

    2011-07-01

    Full Text Available Abstract Background To describe the rationale and design of a future study comparing results of plate fixation and Elastic Stable Intramedullary Nailing (ESIN with a Titanium Elastic Nail (TEN for adults with a dislocated midshaft clavicular fracture. Methods/Design Prospective randomized multicenter clinical trial in two level 1 and one level 2 trauma centers. 120 patients between 18 and 65 years of age will be included. They are randomized to either plate fixation or ESIN with a TEN with a one year follow-up. Sixty patients will be treated with plate fixation and 60 patients will be treated with ESIN. Primary outcome parameter is the Disabilities of the Arm, Shoulder and Hand score after 6 months. Secondary outcome parameters are Constant Shoulder Score, complications, experienced pain, radiologic consolidation and cosmetics after both procedures. Discussion Prospective randomized studies comparing operative techniques for treatment of dislocated midshaft clavicular fracture are lacking. By studying shoulder function, complications, quality of life, radiographic union, cosmetics as well as experienced pain, a complete efficacy assessment of both procedures will be performed. Trial registration The POP study is registered in the Dutch Trial Register (NTR NTR2438.

  11. Endoscopic totally extraperitoneal (TEP) hernia repair for inguinal disruption (Sportsman's hernia): rationale and design of a prospective observational cohort study (TEP-ID-study)

    Voorbrood, C E H; Goedhart, E; Verleisdonk, E J M M; Sanders, F; Naafs, D; Burgmans, J P J

    2016-01-01

    Introduction Chronic inguinal pain is a frequently occurring problem in athletes. A diagnosis of inguinal disruption is performed by exclusion of other conditions causing groin pain. Up to now, conservative medical management is considered to be the primary treatment for this condition. Relevant large and prospective clinical studies regarding the treatment of inguinal disruption are limited; however, recent studies have shown the benefits of the totally extraperitoneal patch (TEP) technique. This study provides a complete assessment of the inguinal area in athletes with chronic inguinal pain before and after treatment with the TEP hernia repair technique. Methods and analysis We describe the rationale and design of an observational cohort study for surgical treatment with the endoscopic TEP hernia repair technique in athletes with a painful groin (inguinal disruption). The study is being conducted in a high-volume, single centre hospital with specialty in TEP hernia repair. Patients over 18 years, suffering from inguinal pain for at least 3 months during or after playing sports, and whom have not undergone previous inguinal surgery and have received no benefit from physiotherapy are eligible for inclusion. Patients with any another cause of inguinal pain, proven by physical examination, inguinal ultrasound, X-pelvis/hip or MRI are excluded. Primary outcome is reduction in pain after 3 months. Secondary outcomes are pain reduction, physical functioning, and resumption of sport (in frequency and intensity). Ethics and dissemination An unrestricted research grant for general study purposes was assigned to the Hernia Centre. This study itself is not directly subject to the above mentioned research grant or any other financial sponsorship. We intend to publish the outcome of the study, regardless of the findings. All authors will give final approval of the manuscript version to be published. PMID:26739740

  12. Ethical and policy issues in cluster randomized trials: rationale and design of a mixed methods research study

    Chaudhry Shazia H

    2009-07-01

    Full Text Available Abstract Background Cluster randomized trials are an increasingly important methodological tool in health research. In cluster randomized trials, intact social units or groups of individuals, such as medical practices, schools, or entire communities – rather than individual themselves – are randomly allocated to intervention or control conditions, while outcomes are then observed on individual cluster members. The substantial methodological differences between cluster randomized trials and conventional randomized trials pose serious challenges to the current conceptual framework for research ethics. The ethical implications of randomizing groups rather than individuals are not addressed in current research ethics guidelines, nor have they even been thoroughly explored. The main objectives of this research are to: (1 identify ethical issues arising in cluster trials and learn how they are currently being addressed; (2 understand how ethics reviews of cluster trials are carried out in different countries (Canada, the USA and the UK; (3 elicit the views and experiences of trial participants and cluster representatives; (4 develop well-grounded guidelines for the ethical conduct and review of cluster trials by conducting an extensive ethical analysis and organizing a consensus process; (5 disseminate the guidelines to researchers, research ethics boards (REBs, journal editors, and research funders. Methods We will use a mixed-methods (qualitative and quantitative approach incorporating both empirical and conceptual work. Empirical work will include a systematic review of a random sample of published trials, a survey and in-depth interviews with trialists, a survey of REBs, and in-depth interviews and focus group discussions with trial participants and gatekeepers. The empirical work will inform the concurrent ethical analysis which will lead to a guidance document laying out principles, policy options, and rationale for proposed guidelines. An

  13. Study to prospectively evaluate reamed intramedually nails in patients with tibial fractures (S.P.R.I.N.T.: Study rationale and design

    2008-06-01

    Full Text Available Abstract Background Surgeons agree on the benefits of operative treatment of tibial fractures – the most common of long bone fractures – with an intramedullary rod or nail. Rates of re-operation remain high – between 23% and 60% in prior trials – and the two alternative nailing approaches, reamed or non-reamed, each have a compelling biological rationale and strong proponents, resulting in ongoing controversy regarding which is better. Methods/Design The objective of this trial was to assess the impact of reamed versus non-reamed intramedullary nailing on rates of re-operation in patients with open and closed fractures of the tibial shaft. The study to prospectively evaluate reamed intramedullary nails in tibial fractures (S.P.R.I.N.T was a multi-center, randomized trial including 29 clinical sites in Canada, the United States and the Netherlands which enrolled 1200 skeletally mature patients with open (Gustilo Types I-IIIB or closed (Tscherne Types 0–3 fractures of the tibial shaft amenable to surgical treatment with an intramedullary nail. Patients received a statically locked intramedullary nail with either reamed or non-reamed insertion. The first strategy involved fixation of the fracture with an intramedullary nail following reaming to enlarge the intramedullary canal (Reamed Group. The second treatment strategy involved fixation of the fracture with an intramedullary nail without prior reaming of the intramedullary canal (Non-Reamed Group. Patients, outcome assessors, and data analysts were blinded to treatment allocation. Peri-operative care was standardized, and re-operations before 6 months were proscribed. Patients were followed at discharge, 2 weeks post-discharge, and at 6 weeks, 3, 6, 9, and 12 months post surgery. A committee, blinded to allocation, adjudicated all outcomes. Discussion The primary outcome was re-operation to promote healing, treat infection, or preserve the limb (fasciotomy for compartment syndrome after

  14. Rationale, study design, and analysis plan of the Alveolar Recruitment for ARDS Trial (ART: Study protocol for a randomized controlled trial

    2012-08-01

    Full Text Available Abstract Background Acute respiratory distress syndrome (ARDS is associated with high in-hospital mortality. Alveolar recruitment followed by ventilation at optimal titrated PEEP may reduce ventilator-induced lung injury and improve oxygenation in patients with ARDS, but the effects on mortality and other clinical outcomes remain unknown. This article reports the rationale, study design, and analysis plan of the Alveolar Recruitment for ARDS Trial (ART. Methods/Design ART is a pragmatic, multicenter, randomized (concealed, controlled trial, which aims to determine if maximum stepwise alveolar recruitment associated with PEEP titration is able to increase 28-day survival in patients with ARDS compared to conventional treatment (ARDSNet strategy. We will enroll adult patients with ARDS of less than 72 h duration. The intervention group will receive an alveolar recruitment maneuver, with stepwise increases of PEEP achieving 45 cmH2O and peak pressure of 60 cmH2O, followed by ventilation with optimal PEEP titrated according to the static compliance of the respiratory system. In the control group, mechanical ventilation will follow a conventional protocol (ARDSNet. In both groups, we will use controlled volume mode with low tidal volumes (4 to 6 mL/kg of predicted body weight and targeting plateau pressure ≤30 cmH2O. The primary outcome is 28-day survival, and the secondary outcomes are: length of ICU stay; length of hospital stay; pneumothorax requiring chest tube during first 7 days; barotrauma during first 7 days; mechanical ventilation-free days from days 1 to 28; ICU, in-hospital, and 6-month survival. ART is an event-guided trial planned to last until 520 events (deaths within 28 days are observed. These events allow detection of a hazard ratio of 0.75, with 90% power and two-tailed type I error of 5%. All analysis will follow the intention-to-treat principle. Discussion If the ART strategy with maximum recruitment and PEEP titration improves

  15. Study rationale and design of OPTIMISE, a randomised controlled trial on the effect of benchmarking on quality of care in type 2 diabetes mellitus

    Hermans Michel P

    2011-09-01

    Full Text Available Abstract Background To investigate the effect of physician- and patient-specific feedback with benchmarking on the quality of care in adults with type 2 diabetes mellitus (T2DM. Methods Study centres in six European countries were randomised to either a benchmarking or control group. Physicians in both groups received feedback on modifiable outcome indicators (glycated haemoglobin [HbA1c], glycaemia, total cholesterol, high density lipoprotein-cholesterol, low density lipoprotein [LDL]-cholesterol and triglycerides for each patient at 0, 4, 8 and 12 months, based on the four times yearly control visits recommended by international guidelines. The benchmarking group also received comparative results on three critical quality indicators of vascular risk (HbA1c, LDL-cholesterol and systolic blood pressure [SBP], checked against the results of their colleagues from the same country, and versus pre-set targets. After 12 months of follow up, the percentage of patients achieving the pre-determined targets for the three critical quality indicators will be assessed in the two groups. Results Recruitment was completed in December 2008 with 3994 evaluable patients. Conclusions This paper discusses the study rationale and design of OPTIMISE, a randomised controlled study, that will help assess whether benchmarking is a useful clinical tool for improving outcomes in T2DM in primary care. Trial registration NCT00681850

  16. Study to prospectively evaluate reamed intramedually nails in patients with tibial fractures (S.P.R.I.N.T.): Study rationale and design

    ,

    2008-01-01

    Background Surgeons agree on the benefits of operative treatment of tibial fractures – the most common of long bone fractures – with an intramedullary rod or nail. Rates of re-operation remain high – between 23% and 60% in prior trials – and the two alternative nailing approaches, reamed or non-reamed, each have a compelling biological rationale and strong proponents, resulting in ongoing controversy regarding which is better. Methods/Design The objective of this trial was to assess the impac...

  17. A randomised trial of the Flinders Program to improve patient self-management competencies in a range of chronic conditions: study rationale and protocol

    Malcolm W. Battersby

    2010-03-01

    Full Text Available BackgroundSupporting self management is seen as an important healthservice strategy in dealing with the large and increasing healthburden of chronic conditions. Several types of selfmanagementprograms are available. Evidence to datesuggests that disease-specific and lay-led self managementprograms provide only part of the support needed forimproved outcomes. The Flinders Program is promising as ageneric self management intervention, which can becombined with targeted disease-specific and lay-ledinterventions, but it has yet to be evaluated for a range ofchronic conditions using a rigorous controlled trial design. Thispaper gives the rationale for a randomised controlled trial andprocess evaluation of the Flinders Program of chroniccondition self-management in community practice, and detailsand justifies the design of such a study.MethodThe design for a randomised trial and associated processevaluation, suited to evaluation of a complex and behaviouralintervention as it is applied in actual practice, is presented andjustified.ConclusionA randomised trial of the Flinders Program is required and afunctional design is presented. Results from this trial,currently underway, will test the effectiveness of the FlindersProgram in improving patient competencies in selfmanagementof chronic conditions in practice conditions.A process evaluation alongside the trial will exploresystem, provider and patient factors associated withgreater and lesser Program effectiveness.

  18. Rationale and design of the Leipzig (LIFE Heart Study: phenotyping and cardiovascular characteristics of patients with coronary artery disease.

    Frank Beutner

    Full Text Available OBJECTIVE: We established the Leipzig (LIFE Heart Study, a biobank and database of patients with different stages of coronary artery disease (CAD for studies of clinical, metabolic, cellular and genetic factors of cardiovascular diseases. DESIGN: The Leipzig (LIFE Heart Study (NCT00497887 is an ongoing observational angiographic study including subjects with different entities of CAD. Cohort 1, patients undergoing first-time diagnostic coronary angiography due to suspected stable CAD with previously untreated coronary arteries. Cohort 2, patients with acute myocardial infarction (MI requiring percutaneous revascularization. Cohort 3, patients with known left main coronary artery disease (LMCAD. RESULTS: We present preliminary results of demographics and phenotyping based on a 4-years analysis of a total of 3,165 subjects. Cohort 1 (n=2,274 shows the typical distribution of elective coronary angiography cohorts with 43% cases with obstructive CAD and 37% normal angiograms. Cohorts 2 and 3 consist of 590 and 301 subjects, respectively, adding patients with severe forms of CAD. The suitability of the database and biobank to perform association studies was confirmed by replication of the CAD susceptibility locus on chromosome 9p21 (OR per allele: 1.55 (any CAD, 1.54 (MI, 1.74 (LMCAD, p<10(-6, respectively. A novel finding was that patients with LMCAD had a stronger association with 9p21 than patients with obstructive CAD without LMCAD (OR 1.22, p=0.042. In contrast, 9p21 did not associate with myocardial infarction in excess of stable CAD. CONCLUSION: The Leipzig (LIFE Heart Study provides a basis to identify molecular targets related to atherogenesis and associated metabolic disorders. The study may contribute to an improvement of individual prediction, prevention, and treatment of CAD.

  19. A framework for design rationale capture and use during geometry design

    Van Schaik, Jeroen Robbert

    2014-01-01

    Despite broad agreement on the utility of design rationale use and capture, a review of the relevant literature shows that industrial usage remains limited, especially during geometry design. An initial field study confirmed low design rationale capture during the geometry design stage. The lack of linking between design rationale and geometry models is identified as a factor holding back design rationale capture. A toolset is presented to link entities in geometry models to design ra...

  20. Rationale and methods of the European Study on Cardiovascular Risk Prevention and Management in Daily Practice (EURIKA

    Jiménez Francisco

    2010-06-01

    Full Text Available Abstract Background The EURIKA study aims to assess the status of primary prevention of cardiovascular disease (CVD across Europe. Specifically, it will determine the degree of control of cardiovascular risk factors in current clinical practice in relation to the European guidelines on cardiovascular prevention. It will also assess physicians' knowledge and attitudes about CVD prevention as well as the barriers impeding effective risk factor management in clinical practice. Methods/Design Cross-sectional study conducted simultaneously in 12 countries across Europe. The study has two components: firstly at the physician level, assessing eight hundred and nine primary care and specialist physicians with a daily practice in CVD prevention. A physician specific questionnaire captures information regarding physician demographics, practice settings, cardiovascular prevention beliefs and management. Secondly at the patient level, including 7641 patients aged 50 years or older, free of clinical CVD and with at least one classical risk factor, enrolled by the participating physicians. A patient-specific questionnaire captures information from clinical records and patient interview regarding sociodemographic data, CVD risk factors, and current medications. Finally, each patient provides a fasting blood sample, which is sent to a central laboratory for measuring serum lipids, apolipoproteins, hemoglobin-A1c, and inflammatory biomarkers. Discussion Primary prevention of CVD is an extremely important clinical issue, with preventable circulatory diseases remaining the leading cause of major disease burden. The EURIKA study will provide key information to assess effectiveness of and attitudes toward primary prevention of CVD in Europe. A transnational study creates opportunities for benchmarking good clinical practice across countries and improving outcomes. (ClinicalTrials.gov number, NCT00882336.

  1. Controlled study of myocardial recovery after interval training in heart failure: SMARTEX-HF - rationale and design

    Støylen, Asbjørn; Conraads, Viviane; Halle, Martin;

    2011-01-01

    comprising interval training at high relative intensity would yield significantly larger effects in terms of left ventricular remodelling compared to moderate continuous exercise training. Study design: In a three-armed randomized multicentre study of stable heart failure patients with left ventricular...... ejection fraction =35%, the effects of a 12-week programme of high-intensity interval training (HIT; 85-90% of peak oxygen uptake, VO(2peak)) will be compared to actual practice in Europe, represented by either an isocaloric programme of moderate continuous training (MCT; 50-60% of VO(2peak)) and a......Background: The large randomized controlled multicentre clinical trial, HF-ACTION, recently demonstrated that a programme of recommendation of regular exercise training at moderate intensity is safe, improves quality of life, and reduces the combined endpoint of all-cause death and hospitalization...

  2. The Fifth German Oral Health Study (Fünfte Deutsche Mundgesundheitsstudie, DMS V) - rationale, design, and methods

    Jordan, Rainer A; Bodechtel, Constanze; Hertrampf, Katrin; Hoffmann, Thomas; Kocher, Thomas; Nitschke, Ina; Schiffner, Ulrich; STARK, Helmut; Zimmer, Stefan; Micheelis, Wolfgang

    2014-01-01

    Background Oral diseases rank among the most prevalent non-communicable diseases in modern societies. In Germany, oral epidemiological data show that both dental caries and periodontal diseases are highly prevalent, though significant improvements in oral health has been taking in the population within the last decades, particularly in children. It is, therefore, the aim of the Fifth German Oral Health Study (DMS V) to actualize the data on current oral health status and to gather information...

  3. Diet and lifestyle interventions in postpartum women in China: study design and rationale of a multicenter randomized controlled trial

    Fu Juan

    2010-02-01

    Full Text Available Abstract Background "Doing the month", or "sitting month", is a traditional practice for postpartum women in China and other Asian countries, which includes some taboos against well-accepted healthy diet and lifestyles in general population. Previous studies have shown this practice may be associated with higher prevalence of postpartum problems. The current multicenter randomized controlled trial (RCT aims to evaluate outcomes of diet and lifestyle interventions in Chinese postpartum women. Methods/Design The current multicenter RCT will be conducted in three representative areas in China, Shandong province, Hubei province and Guangdong province, which locate in northern, central and southern parts of China, respectively. Women who attend routine pregnancy diagnosis in hospitals or maternal healthcare centers will be invited to take part in this study. At least 800 women who meet our eligibility criteria will be recruited and randomly assigned to the intervention group (n > = 400 and the control group (n > = 400. A three-dimension comprehensive intervention strategy, which incorporates intervention measures simultaneously to individual postpartum woman, their family members and community environment, will be utilized to maximize the effectiveness of intervention. Regular visiting and follow-up will be done in both group; nutrition and health-related measurements will be assessed both before and after the intervention. Discussion To our knowledge, this current study is the first and largest multicenter RCT which focus on the effectiveness of diet and lifestyle intervention on reducing the incidence rate of postpartum diseases and improving health status in postpartum women. We hypothesize that the intervention will reduce the incidence rates of postpartum diseases and improve nutrition and health status due to a balanced diet and reasonable lifestyle in comparison with the control condition. If so, the results of our study will provide

  4. Research on Emissions, Air quality, Climate, and Cooking Technologies in Northern Ghana (REACCTING): study rationale and protocol

    Dickinson, Katherine L; Kanyomse, Ernest; Piedrahita, Ricardo; Coffey, Evan; Rivera, Isaac J; Adoctor, James; Alirigia, Rex; Muvandimwe, Didier; Dove, MacKenzie; Dukic, Vanja; Hayden, Mary H.; Diaz-Sanchez, David; Abisiba, Adoctor Victor; Anaseba, Dominic; Hagar, Yolanda

    2015-01-01

    Background Cooking over open fires using solid fuels is both common practice throughout much of the world and widely recognized to contribute to human health, environmental, and social problems. The public health burden of household air pollution includes an estimated four million premature deaths each year. To be effective and generate useful insight into potential solutions, cookstove intervention studies must select cooking technologies that are appropriate for local socioeconomic conditio...

  5. British randomised controlled trial of AV and VV optimization (“BRAVO”) study: rationale, design, and endpoints

    Whinnett, Z I; Sohaib, S. M.; Jones, S; Kyriacou, A.; March, K.; Coady, E.; Mayet, J; Hughes, A. D.; Frenneaux, M.; Francis, D. P.; BRAVO Investigators, The

    2014-01-01

    Background Echocardiographic optimization of pacemaker settings is the current standard of care for patients treated with cardiac resynchronization therapy. However, the process requires considerable time of expert staff. The BRAVO study is a non-inferiority trial comparing echocardiographic optimization of atrioventricular (AV) and interventricular (VV) delay with an alternative method using non-invasive blood pressure monitoring that can be automated to consume less staff resources. Methods...

  6. Rationale, design, methodology and sample characteristics for the Vietnam pre-conceptual micronutrient supplementation trial (PRECONCEPT: a randomized controlled study

    Nguyen Phuong H

    2012-10-01

    Full Text Available Abstract Background Low birth weight and maternal anemia remain intractable problems in many developing countries. The adequacy of the current strategy of providing iron-folic acid (IFA supplements only during pregnancy has been questioned given many women enter pregnancy with poor iron stores, the substantial micronutrient demand by maternal and fetal tissues, and programmatic issues related to timing and coverage of prenatal care. Weekly IFA supplementation for women of reproductive age (WRA improves iron status and reduces the burden of anemia in the short term, but few studies have evaluated subsequent pregnancy and birth outcomes. The Preconcept trial aims to determine whether pre-pregnancy weekly IFA or multiple micronutrient (MM supplementation will improve birth outcomes and maternal and infant iron status compared to the current practice of prenatal IFA supplementation only. This paper provides an overview of study design, methodology and sample characteristics from baseline survey data and key lessons learned. Methods/design We have recruited 5011 WRA in a double-blind stratified randomized controlled trial in rural Vietnam and randomly assigned them to receive weekly supplements containing either: 1 2800 μg folic acid 2 60 mg iron and 2800 μg folic acid or 3 MM. Women who become pregnant receive daily IFA, and are being followed through pregnancy, delivery, and up to three months post-partum. Study outcomes include birth outcomes and maternal and infant iron status. Data are being collected on household characteristics, maternal diet and mental health, anthropometry, infant feeding practices, morbidity and compliance. Discussion The study is timely and responds to the WHO Global Expert Consultation which identified the need to evaluate the long term benefits of weekly IFA and MM supplementation in WRA. Findings will generate new information to help guide policy and programs designed to reduce the burden of anemia in women and

  7. Studying variability in human brain aging in a population-based German cohort – Rationale and design of 1000BRAINS

    Svenja eCaspers

    2014-07-01

    Full Text Available The ongoing 1000 brains study (1000BRAINS is an epidemiological and neuroscientific investigation of structural and functional variability in the human brain during aging. The two recruitment sources are the 10-year follow-up cohort of the German Heinz Nixdorf Recall (HNR Study, and the HNR MultiGeneration Study cohort, which comprises spouses and offspring of HNR subjects. The HNR is a longitudinal epidemiological investigation of cardiovascular risk factors, with a comprehensive collection of clinical, laboratory, socioeconomic, and environmental data from population-based subjects aged 45-75 years on inclusion. HNR subjects underwent detailed assessments in 2000, 2006, and 2011, and completed annual postal questionnaires on health status. 1000BRAINS accesses these HNR data and applies a separate protocol comprising: neuropsychological tests of attention, memory, executive functions & language; examination of motor skills; ratings of personality, life quality, mood & daily activities; analysis of laboratory and genetic data; and state-of-the-art magnetic resonance imaging (MRI, 3 Tesla of the brain. The latter includes (i 3D-T1- and 3D-T2-weighted scans for structural analyses and myelin mapping; (ii three diffusion imaging sequences optimized for diffusion tensor imaging, high-angular resolution diffusion imaging for detailed fibre tracking and for diffusion kurtosis imaging; (iii resting-state and task-based functional MRI; and (iv fluid-attenuated inversion recovery and MR angiography for the detection of vascular lesions and the mapping of white matter lesions. The unique design of 1000BRAINS allows: (i comprehensive investigation of various influences including genetics, environment and health status on variability in brain structure and function during aging; and (ii identification of the impact of selected influencing factors on specific cognitive subsystems and their anatomical correlates.

  8. Studying variability in human brain aging in a population-based German cohort-rationale and design of 1000BRAINS.

    Caspers, Svenja; Moebus, Susanne; Lux, Silke; Pundt, Noreen; Schütz, Holger; Mühleisen, Thomas W; Gras, Vincent; Eickhoff, Simon B; Romanzetti, Sandro; Stöcker, Tony; Stirnberg, Rüdiger; Kirlangic, Mehmet E; Minnerop, Martina; Pieperhoff, Peter; Mödder, Ulrich; Das, Samir; Evans, Alan C; Jöckel, Karl-Heinz; Erbel, Raimund; Cichon, Sven; Nöthen, Markus M; Sturma, Dieter; Bauer, Andreas; Jon Shah, N; Zilles, Karl; Amunts, Katrin

    2014-01-01

    The ongoing 1000 brains study (1000BRAINS) is an epidemiological and neuroscientific investigation of structural and functional variability in the human brain during aging. The two recruitment sources are the 10-year follow-up cohort of the German Heinz Nixdorf Recall (HNR) Study, and the HNR MultiGeneration Study cohort, which comprises spouses and offspring of HNR subjects. The HNR is a longitudinal epidemiological investigation of cardiovascular risk factors, with a comprehensive collection of clinical, laboratory, socioeconomic, and environmental data from population-based subjects aged 45-75 years on inclusion. HNR subjects underwent detailed assessments in 2000, 2006, and 2011, and completed annual postal questionnaires on health status. 1000BRAINS accesses these HNR data and applies a separate protocol comprising: neuropsychological tests of attention, memory, executive functions and language; examination of motor skills; ratings of personality, life quality, mood and daily activities; analysis of laboratory and genetic data; and state-of-the-art magnetic resonance imaging (MRI, 3 Tesla) of the brain. The latter includes (i) 3D-T1- and 3D-T2-weighted scans for structural analyses and myelin mapping; (ii) three diffusion imaging sequences optimized for diffusion tensor imaging, high-angular resolution diffusion imaging for detailed fiber tracking and for diffusion kurtosis imaging; (iii) resting-state and task-based functional MRI; and (iv) fluid-attenuated inversion recovery and MR angiography for the detection of vascular lesions and the mapping of white matter lesions. The unique design of 1000BRAINS allows: (i) comprehensive investigation of various influences including genetics, environment and health status on variability in brain structure and function during aging; and (ii) identification of the impact of selected influencing factors on specific cognitive subsystems and their anatomical correlates. PMID:25071558

  9. Prevalence of peripheral arterial disease in patients at non-high cardiovascular risk. Rationale and design of the PANDORA study

    Cimminiello Claudio

    2010-08-01

    Full Text Available Abstract Background Lower extremity peripheral arterial disease (PAD is a marker of widespread atherosclerosis. Individuals with PAD, most of whom do not show typical PAD symptoms ('asymptomatic' patients, are at increased risk of cardiovascular ischaemic events. American College of Cardiology/American Heart Association guidelines recommend that individuals with asymptomatic lower extremity PAD should be identified by measurement of ankle-brachial index (ABI. However, despite its associated risk, PAD remains under-recognised by clinicians and the general population and office-based ABI detection is still poorly-known and under-used in clinical practice. The Prevalence of peripheral Arterial disease in patients with a non-high cardiovascular disease risk, with No overt vascular Diseases nOR diAbetes mellitus (PANDORA study has a primary aim of assessing the prevalence of lower extremity PAD through ABI measurement, in patients at non-high cardiovascular risk, with no overt cardiovascular diseases (including symptomatic PAD, or diabetes mellitus. Secondary objectives include documenting the prevalence and treatment of cardiovascular risk factors and the characteristics of both patients and physicians as possible determinants for PAD under-diagnosis. Methods/Design PANDORA is a non-interventional, cross-sectional, pan-European study. It includes approximately 1,000 primary care participating sites, across six European countries (Belgium, France, Greece, Italy, The Netherlands, Switzerland. Investigator and patient questionnaires will be used to collect both right and left ABI values at rest, presence of cardiovascular disease risk factors, current pharmacological treatment, and determinants for PAD under-diagnosis. Discussion The PANDORA study will provide important data to estimate the prevalence of asymptomatic PAD in a population otherwise classified at low or intermediate risk on the basis of current risk scores in a primary care setting. Trial

  10. The VA augmentation and switching treatments for improving depression outcomes (VAST-D) study: Rationale and design considerations.

    Mohamed, Somaia; Johnson, Gary R; Vertrees, Julia E; Guarino, Peter D; Weingart, Kimberly; Young, Ilanit Tal; Yoon, Jean; Gleason, Theresa C; Kirkwood, Katherine A; Kilbourne, Amy M; Gerrity, Martha; Marder, Stephen; Biswas, Kousick; Hicks, Paul; Davis, Lori L; Chen, Peijun; Kelada, AlexandraMary; Huang, Grant D; Lawrence, David D; LeGwin, Mary; Zisook, Sidney

    2015-10-30

    Because two-thirds of patients with Major Depressive Disorder do not achieve remission with their first antidepressant, we designed a trial of three "next-step" strategies: switching to another antidepressant (bupropion-SR) or augmenting the current antidepressant with either another antidepressant (bupropion-SR) or with an atypical antipsychotic (aripiprazole). The study will compare 12-week remission rates and, among those who have at least a partial response, relapse rates for up to 6 months of additional treatment. We review seven key efficacy/effectiveness design decisions in this mixed "efficacy-effectiveness" trial. PMID:26279130

  11. International Study to Predict Optimized Treatment for Depression (iSPOT-D, a randomized clinical trial: rationale and protocol

    Cooper Nicholas J

    2011-01-01

    Full Text Available Abstract Background Clinically useful treatment moderators of Major Depressive Disorder (MDD have not yet been identified, though some baseline predictors of treatment outcome have been proposed. The aim of iSPOT-D is to identify pretreatment measures that predict or moderate MDD treatment response or remission to escitalopram, sertraline or venlafaxine; and develop a model that incorporates multiple predictors and moderators. Methods/Design The International Study to Predict Optimized Treatment - in Depression (iSPOT-D is a multi-centre, international, randomized, prospective, open-label trial. It is enrolling 2016 MDD outpatients (ages 18-65 from primary or specialty care practices (672 per treatment arm; 672 age-, sex- and education-matched healthy controls. Study-eligible patients are antidepressant medication (ADM naïve or willing to undergo a one-week wash-out of any non-protocol ADM, and cannot have had an inadequate response to protocol ADM. Baseline assessments include symptoms; distress; daily function; cognitive performance; electroencephalogram and event-related potentials; heart rate and genetic measures. A subset of these baseline assessments are repeated after eight weeks of treatment. Outcomes include the 17-item Hamilton Rating Scale for Depression (primary and self-reported depressive symptoms, social functioning, quality of life, emotional regulation, and side-effect burden (secondary. Participants may then enter a naturalistic telephone follow-up at weeks 12, 16, 24 and 52. The first half of the sample will be used to identify potential predictors and moderators, and the second half to replicate and confirm. Discussion First enrolment was in December 2008, and is ongoing. iSPOT-D evaluates clinical and biological predictors of treatment response in the largest known sample of MDD collected worldwide. Trial registration International Study to Predict Optimised Treatment - in Depression (iSPOT-D ClinicalTrials.gov Identifier

  12. High-dose N-acetylcysteine in the prevention of COPD exacerbations: rationale and design of the PANTHEON Study.

    Zheng, Jin-Ping; Wen, Fu-Qiang; Bai, Chun-Xue; Wan, Huan-Ying; Kang, Jian; Chen, Ping; Yao, Wan-Zhen; Ma, Li-Jun; Xia, Qi-Kui; Gao, Yi; Zhong, Nan-Shan

    2013-04-01

    Chronic obstructive pulmonary disease (COPD) is characterized by persistent airflow limitation; from a pathophysiological point of view it involves many components, including mucus hypersecretion, oxidative stress and inflammation. N-acetylcysteine (NAC) is a mucolytic agent with antioxidant and anti-inflammatory properties. Long-term efficacy of NAC 600mg/d in COPD is controversial; a dose-effect relationship has been demonstrated, but at present it is not known whether a higher dose provides clinical benefits. The PANTHEON Study is a prospective, ICS stratified, randomized, double-blind, placebo-controlled, parallel-group, multi-center trial designed to assess the efficacy and safety of high-dose (1200 mg/daily) NAC treatment for one year in moderate-to-severe COPD patients. The primary endpoint is the annual exacerbation rate. Secondary endpoints include recurrent exacerbations hazard ratio, time to first exacerbation, as well as quality of life and pulmonary function. The hypothesis, design and methodology are described and baseline characteristics of recruited patients are presented. 1006 COPD patients (444 treated with maintenance ICS, 562 ICS naive, aged 66.27±8.76 yrs, average post-bronchodilator FEV1 48.95±11.80 of predicted) have been randomized at 34 hospitals in China. Final results of this study will provide objective data on the effects of high-dose (1200 mg/daily) long-term NAC treatment in the prevention of COPD exacerbations and other outcome variables. PMID:23061828

  13. Stroke risk associated with balloon based catheter ablation for atrial fibrillation: Rationale and design of the MACPAF Study

    Schultheiss Heinz-Peter

    2010-07-01

    Full Text Available Abstract Background Catheter ablation of the pulmonary veins has become accepted as a standard therapeutic approach for symptomatic paroxysmal atrial fibrillation (AF. However, there is some evidence for an ablation associated (silent stroke risk, lowering the hope to limit the stroke risk by restoration of rhythm over rate control in AF. The purpose of the prospective randomized single-center study "Mesh Ablator versus Cryoballoon Pulmonary Vein Ablation of Symptomatic Paroxysmal Atrial Fibrillation" (MACPAF is to compare the efficacy and safety of two balloon based pulmonary vein ablation systems in patients with symptomatic paroxysmal AF. Methods/Design Patients are randomized 1:1 for the Arctic Front® or the HD Mesh Ablator® catheter for left atrial catheter ablation (LACA. The predefined endpoints will be assessed by brain magnetic resonance imaging (MRI, neuro(psychological tests and a subcutaneously implanted reveal recorder for AF detection. According to statistics 108 patients will be enrolled. Discussion Findings from the MACPAF trial will help to balance the benefits and risks of LACA for symptomatic paroxysmal AF. Using serial brain MRIs might help to identify patients at risk for LACA-associated cerebral thromboembolism. Potential limitations of the study are the single-center design, the existence of a variety of LACA-catheters, the missing placebo-group and the impossibility to assess the primary endpoint in a blinded fashion. Trial registration clinicaltrials.gov NCT01061931

  14. Barriers, facilitators and preferences for the physical activity of school children. Rationale and methods of a mixed study

    Martínez-Andrés María

    2012-09-01

    Full Text Available Abstract Background Physical activity interventions in schools environment seem to have shown some effectiveness in the control of the current obesity epidemic in children. However the complexity of behaviors and the diversity of influences related to this problem suggest that we urgently need new lines of insight about how to support comprehensive population strategies of intervention. The aim of this study was to know the perceptions of the children from Cuenca, about their environmental barriers, facilitators and preferences for physical activity. Methods/Design We used a mixed-method design by combining two qualitative methods (analysis of individual drawings and focus groups together with the quantitative measurement of physical activity through accelerometers, in a theoretical sample of 121 children aged 9 and 11 years of schools in the province of Cuenca, Spain. Conclusions Mixed-method study is an appropriate strategy to know the perceptions of children about barriers and facilitators for physical activity, using both qualitative methods for a deeply understanding of their points of view, and quantitative methods for triangulate the discourse of participants with empirical data. We consider that this is an innovative approach that could provide knowledges for the development of more effective interventions to prevent childhood overweight.

  15. Aspirin for the prevention of cognitive decline in the elderly: rationale and design of a neuro-vascular imaging study (ENVIS-ion

    Reid Christopher M

    2012-02-01

    Full Text Available Abstract Background This paper describes the rationale and design of the ENVIS-ion Study, which aims to determine whether low-dose aspirin reduces the development of white matter hyper-intense (WMH lesions and silent brain infarction (SBI. Additional aims include determining whether a changes in retinal vascular imaging (RVI parameters parallel changes in brain magnetic resonance imaging (MRI; b changes in RVI parameters are observed with aspirin therapy; c baseline cognitive function correlates with MRI and RVI parameters; d changes in cognitive function correlate with changes in brain MRI and RVI and e whether factors such as age, gender or blood pressure influence the above associations. Methods/Design Double-blind, placebo-controlled trial of three years duration set in two Australian academic medical centre outpatient clinics. This study will enrol 600 adults aged 70 years and over with normal cognitive function and without overt cardiovascular disease. Subjects will undergo cognitive testing, brain MRI and RVI at baseline and after 3 years of study treatment. All subjects will be recruited from a 19,000-patient clinical outcome trial conducted in Australia and the United States that will evaluate the effects of aspirin in maintaining disability-free longevity over 5 years. The intervention will be aspirin 100 mg daily versus matching placebo, randomized on a 1:1 basis. Discussion This study will improve understanding of the mechanisms at the level of brain and vascular structure that underlie the effects of aspirin on cognitive function. Given the limited access and high cost of MRI, RVI may prove useful as a tool for the identification of individuals at high risk for the development of cerebrovascular disease and cognitive decline. Trial Registration clinicaltrials.gov Identifier: NCT01038583

  16. Early markers of airways inflammation and occupational asthma: Rationale, study design and follow-up rates among bakery, pastry and hairdressing apprentices

    Hannhart Bernard

    2009-04-01

    Full Text Available Abstract Background Occupational asthma is a common type of asthma caused by a specific agent in the workplace. The basic alteration of occupational asthma is airways inflammation. Although most patients with occupational asthma are mature adults, there is evidence that airways inflammation starts soon after inception of exposure, including during apprenticeship. Airways hyper responsiveness to methacholine is a valid surrogate marker of airways inflammation, which has proved useful in occupational epidemiology. But it is time-consuming, requires active subject's cooperation and is not readily feasible. Other non-invasive and potentially more useful tests include the forced oscillation technique, measurement of fraction exhaled nitric oxide, and eosinophils count in nasal lavage fluid. Methods and design This study aims to investigate early development of airways inflammation and asthma-like symptoms in apprentice bakers, pastry-makers and hairdressers, three populations at risk of occupational asthma whose work-related exposures involve agents of different nature. The objectives are to (i examine the performance of the non-invasive tests cited above in detecting early airways inflammation that might eventually develop into occupational asthma; and (ii evaluate whether, and how, constitutional (e.g. atopy and behavioural (e.g. smoking risk factors for occupational asthma modulate the effects of allergenic and/or irritative substances involved in these occupations. This paper presents the study rationale and detailed protocol. Discussion Among 441 volunteers included at the first visit, 354 attended the fourth one. Drop outs were investigated and showed unrelated to the study outcome. Sample size and follow-up participation rates suggest that the data collected in this study will allow it to meet its objectives.

  17. Rationale and design of XAMOS: noninterventional study of rivaroxaban for prophylaxis of venous thromboembolism after major hip and knee surgery

    Turpie AG

    2012-06-01

    Full Text Available Alexander GG Turpie,1 André C Schmidt,2 Reinhold Kreutz,3 Michael R Lassen,4 Waheed Jama,1,2 Lorenzo Mantovani,5 Sylvia Haas61Department of Medicine, Hamilton Health Sciences, General Division, Ontario, Canada; 2Bayer Healthcare Pharmaceuticals, Global Development, Berlin, Germany; 3Institut für Klinische Pharmakologie und Toxikologie, Charité-Universitätsmedizin Berlin, Campus Mitte, Berlin, Germany; 4Department of Orthopaedics, Spine Clinic, Clinical Trial Unit, Hørsholm Hospital, University of Copenhagen, Hørsholm, Denmark; 5Faculty of Pharmacy, Federico II University of Naples, Naples, Italy; 6Institut für Experimentelle Onkologie und Therapieforschung, TU München, GermanyAbstract: Venous thromboembolism is a frequent and potentially life-threatening complication of orthopedic surgery. Rivaroxaban is an oral direct factor Xa inhibitor, which was shown to be effective for the prevention of venous thromboembolism after elective hip and knee arthroplasty in the RECORD study program. Rivaroxaban has the potential to overcome the limitations of the current standards of care in the prevention of venous thromboembolism. XAMOS (Xarelto® in the prophylaxis of post-surgical venous thromboembolism after elective major orthopedic surgery of hip or knee is an international, noninterventional, parallel-group study to gain insight into the safety (major bleeding, side effects and effectiveness (prevention of symptomatic thromboembolic events of rivaroxaban in daily clinical practice. XAMOS will follow 15,000 patients after major orthopedic surgery in approximately 200 centers worldwide, with about 7500 patients receiving rivaroxaban and about 7500 standard of care. XAMOS will supplement the clinical data obtained in the Phase III RECORD 1, 2, 3, and 4 trials in which rivaroxaban was shown to be superior for the primary efficacy endpoints, and with a safety profile similar to that of enoxaparin after hip or knee replacement surgery. XAMOS was

  18. Antibiotics for bronchiectasis exacerbations in children: rationale and study protocol for a randomised placebo-controlled trial

    Chang Anne B

    2012-08-01

    Full Text Available Abstract Background Despite bronchiectasis being increasingly recognised as an important cause of chronic respiratory morbidity in both indigenous and non-indigenous settings globally, high quality evidence to inform management is scarce. It is assumed that antibiotics are efficacious for all bronchiectasis exacerbations, but not all practitioners agree. Inadequately treated exacerbations may risk lung function deterioration. Our study tests the hypothesis that both oral azithromycin and amoxicillin-clavulanic acid are superior to placebo at improving resolution rates of respiratory exacerbations by day 14 in children with bronchiectasis unrelated to cystic fibrosis. Methods We are conducting a bronchiectasis exacerbation study (BEST, which is a multicentre, randomised, double-blind, double-dummy, placebo-controlled, parallel group trial, in five centres (Brisbane, Perth, Darwin, Melbourne, Auckland. In the component of BEST presented here, 189 children fulfilling inclusion criteria are randomised (allocation-concealed to receive amoxicillin-clavulanic acid (22.5 mg/kg twice daily with placebo-azithromycin; azithromycin (5 mg/kg daily with placebo-amoxicillin-clavulanic acid; or placebo-azithromycin with placebo-amoxicillin-clavulanic acid for 14 days. Clinical data and a paediatric cough-specific quality of life score are obtained at baseline, at the start and resolution of exacerbations, and at day 14. In most children, blood and deep nasal swabs are also collected at the same time points. The primary outcome is the proportion of children whose exacerbations have resolved at day 14. The main secondary outcome is the paediatric cough-specific quality of life score. Other outcomes are time to next exacerbation; requirement for hospitalisation; duration of exacerbation; and spirometry data. Descriptive viral and bacteriological data from nasal samples and blood markers will also be reported. Discussion Effective, evidence-based management

  19. QUest for the Arrhythmogenic Substrate of Atrial fibRillation in Patients Undergoing Cardiac Surgery (QUASAR Study): Rationale and Design.

    van der Does, Lisette J M E; Yaksh, Ameeta; Kik, Charles; Knops, Paul; Lanters, Eva A H; Teuwen, Christophe P; Oei, Frans B S; van de Woestijne, Pieter C; Bekkers, Jos A; Bogers, Ad J J C; Allessie, Maurits A; de Groot, Natasja M S

    2016-06-01

    The heterogeneous presentation and progression of atrial fibrillation (AF) implicate the existence of different pathophysiological processes. Individualized diagnosis and therapy of the arrhythmogenic substrate underlying AF may be required to improve treatment outcomes. Therefore, this single-center study aims to identify the arrhythmogenic areas underlying AF by intra-operative, high-resolution, multi-site epicardial mapping in 600 patients with different heart diseases. Participants are divided into 12 groups according to the underlying heart diseases and presence of prior AF episodes. Mapping is performed with a 192-electrode array for 5-10 s during sinus rhythm and (induced) AF of the entire atrial surface. Local activation times are converted into activation and wave maps from which various electrophysiological parameters are derived. Postoperative cardiac rhythm registrations and a 5-year follow-up will show the incidence of postoperative and persistent AF. This project provides the first step in the development of a tool for individual AF diagnosis and treatment. PMID:26935733

  20. The study of LoSmapimod treatment on inflammation and InfarCtSizE (SOLSTICE): design and rationale.

    Melloni, Chiara; Sprecher, Dennis L; Sarov-Blat, Lea; Patel, Manesh R; Heitner, John F; Hamm, Christian W; Aylward, Philip; Tanguay, Jean-Francois; DeWinter, Robbert J; Marber, Michael S; Lerman, Amir; Hasselblad, Vic; Granger, Christopher B; Newby, L Kristin

    2012-11-01

    The p38 mitogen-activated protein kinase (MAPK) is a nexus point in inflammation, sensing, and stimulating cytokine production and driving cell migration and death. In acute coronary syndromes, p38MAPK inhibition could stabilize ruptured atherosclerotic plaques, pacify active plaques, and improve microvascular function, thereby reducing infarct size and risk of subsequent cardiac events. The SOLSTICE trial is randomized, double-blind, placebo-controlled, parallel group, multicenter phase 2a study of 535 patients that evaluates the safety and efficacy of losmapimod (GW856553), a potent oral p38MAPK inhibitor, vs placebo in patients with non-ST-segment elevation myocardial infarction expected to undergo an invasive strategy. The coprimary end points are reduction in high-sensitivity C-reactive protein at 12 weeks and reduction in infarct size as assessed by troponin area under the curve at 72 hours. A key secondary end point is 72-hour and 12-week B-type natriuretic peptide levels as a measure of cardiac remodeling and ventricular strain. The primary safety assessments are serious and nonserious adverse events, results of liver function testing, and major adverse cardiac events. Cardiac magnetic resonance imaging (N = 117) and coronary flow reserve (N = 13) substudies will assess the effects of losmapimod on infarct size, myocardial function, and coronary vasoregulation. Information gained from the SOLSTICE trial will inform further testing of this agent in larger clinical trials. PMID:23137494

  1. Computer-administered neurobehavioral evaluation system for occupational and environmental epidemiology. Rationale, methodology, and pilot study results

    Baker, E.L.; Letz, R.; Fidler, A.

    1985-03-01

    To facilitate the conduct of epidemiologic studies of populations at risk for or suffering from central nervous system (CNS) dysfunction due to environmental agents, a computer-administered neurobehavioral evaluation system has been developed. The system includes a set of testing programs designed to run on a microcomputer and questionnaires to facilitate interpretation of results. Standard tasks evaluating memory, psychomotor function, verbal ability, visuospatial ability, and mood were selected and adapted for computer presentation following the recommendation of an expert committee of the World Health Organization and the National Institute for Occupational Safety and Health. In two pilot surveys, test performance was found to be influenced by age, education level, and socioeconomic status in ways consistent with prior research findings. Performance on tests of short-term memory and reaction time was negatively correlated with intensity of organic solvent exposure among industrial painters. In view of the ease of administration and data handling, high subject acceptability, and sensitivity to the effects of known neurotoxic agents, computer-based assessment of CNS function holds promise for future epidemiologic research.

  2. The Nutrition and Enjoyable Activity for Teen Girls (NEAT girls randomized controlled trial for adolescent girls from disadvantaged secondary schools: rationale, study protocol, and baseline results

    Okely Anthony D

    2010-10-01

    Full Text Available Abstract Background Child and adolescent obesity predisposes individuals to an increased risk of morbidity and mortality from a range of lifestyle diseases. Although there is some evidence to suggest that rates of pediatric obesity have leveled off in recent years, this has not been the case among youth from low socioeconomic backgrounds. The purpose of this paper is to report the rationale, study design and baseline findings of a school-based obesity prevention program for low-active adolescent girls from disadvantaged secondary schools. Methods/Design The Nutrition and Enjoyable Activity for Teen Girls (NEAT Girls intervention will be evaluated using a group randomized controlled trial. NEAT Girls is a 12-month multi-component school-based intervention developed in reference to Social Cognitive Theory and includes enhanced school sport sessions, interactive seminars, nutrition workshops, lunch-time physical activity (PA sessions, PA and nutrition handbooks, parent newsletters, pedometers for self-monitoring and text messaging for social support. The following variables were assessed at baseline and will be completed again at 12- and 24-months: adiposity, objectively measured PA, muscular fitness, time spent in sedentary behaviors, dietary intake, PA and nutrition social-cognitive mediators, physical self-perception and global self-esteem. Statistical analyses will follow intention-to-treat principles and hypothesized mediators of PA and nutrition behavior change will be explored. Discussion NEAT Girls is an innovative intervention targeting low-active girls using evidence-based behavior change strategies and nutrition and PA messages and has the potential to prevent unhealthy weight gain and reduce the decline in physical activity and poor dietary habits associated with low socio-economic status. Few studies have reported the long-term effects of school-based obesity prevention programs and the current study has the potential to make an

  3. Rationale and study design of a three-period, 58-week trial of ferric citrate as a phosphate binder in patients with ESRD on dialysis.

    Umanath, Kausik; Sika, Mohammed; Niecestro, Robert; Connelly, Carolyn; Schulman, Gerald; Koury, Mark J; Lewis, Julia B; Dwyer, Jamie P

    2013-01-01

    Chronic kidney disease associated mineral and bone disorders arise as a result of aberrant bone mineral metabolism in patients with advancing levels of renal dysfunction and end-stage renal disease. One of the cornerstones of treatment is the use of phosphate-binding agents. We describe the rationale and study design for a clinical trial to assess the safety and efficacy of ferric citrate as a phosphate binder. This trial is a three-period, international, multicenter, randomized, controlled clinical trial to assess the safety and efficacy of ferric citrate as a phosphate binder, consisting of a 2-week washout period, a 52-week safety assessment period in which subjects are randomized to ferric citrate or active control, and a 4-week efficacy assessment period in which subjects randomized to ferric citrate in the safety assessment period are randomized to ferric citrate or placebo. Eligible subjects include end-stage renal disease patients who have been treated with thrice-weekly hemodialysis or peritoneal dialysis for at least 3 months in dialysis clinics in the United States and Israel. Primary outcome measure will be the effect of ferric citrate vs. placebo on the change in serum phosphorus. Safety assessments will be performed by monitoring adverse events, concomitant medication use, and sequential blood chemistries (including iron parameters, phosphorus, and calcium). This three-period trial will assess the efficacy of ferric citrate as a phosphate binder. If proven safe and efficacious, ferric citrate will likely provide an additional phosphate binder to treat chronic kidney disease associated mineral and bone disorders. PMID:22702490

  4. Effect of genetic testing for risk of type 2 diabetes mellitus on health behaviors and outcomes: study rationale, development and design

    Cho Alex H

    2012-01-01

    Full Text Available Abstract Background Type 2 diabetes is a prevalent chronic condition globally that results in extensive morbidity, decreased quality of life, and increased health services utilization. Lifestyle changes can prevent the development of diabetes, but require patient engagement. Genetic risk testing might represent a new tool to increase patients' motivation for lifestyle changes. Here we describe the rationale, development, and design of a randomized controlled trial (RCT assessing the clinical and personal utility of incorporating type 2 diabetes genetic risk testing into comprehensive diabetes risk assessments performed in a primary care setting. Methods/Design Patients are recruited in the laboratory waiting areas of two primary care clinics and enrolled into one of three study arms. Those interested in genetic risk testing are randomized to receive either a standard risk assessment (SRA for type 2 diabetes incorporating conventional risk factors plus upfront disclosure of the results of genetic risk testing ("SRA+G" arm, or the SRA alone ("SRA" arm. Participants not interested in genetic risk testing will not receive the test, but will receive SRA (forming a third, "no-test" arm. Risk counseling is provided by clinic staff (not study staff external to the clinic. Fasting plasma glucose, insulin levels, body mass index (BMI, and waist circumference are measured at baseline and 12 months, as are patients' self-reported behavioral and emotional responses to diabetes risk information. Primary outcomes are changes in insulin resistance and BMI after 12 months; secondary outcomes include changes in diet patterns, physical activity, waist circumference, and perceived risk of developing diabetes. Discussion The utility, feasibility, and efficacy of providing patients with genetic risk information for common chronic diseases in primary care remain unknown. The study described here will help to establish whether providing type 2 diabetes genetic risk

  5. West End Walkers 65+: A randomised controlled trial of a primary care-based walking intervention for older adults: Study rationale and design

    Rowe David A

    2011-02-01

    Full Text Available Abstract Background In Scotland, older adults are a key target group for physical activity intervention due to the large proportion who are inactive. The health benefits of an active lifestyle are well established but more research is required on the most effective interventions to increase activity in older adults. The 'West End Walkers 65+' randomised controlled trial aims to examine the feasibility of delivering a pedometer-based walking intervention to adults aged ≥65 years through a primary care setting and to determine the efficacy of this pilot. The study rationale, protocol and recruitment process are discussed in this paper. Methods/Design The intervention consisted of a 12-week pedometer-based graduated walking programme and physical activity consultations. Participants were randomised into an immediate intervention group (immediate group or a 12-week waiting list control group (delayed group who then received the intervention. For the pilot element of this study, the primary outcome measure was pedometer step counts. Secondary outcome measures of sedentary time and physical activity (time spent lying/sitting, standing or walking; activPAL™ monitor, mood (Positive and Negative Affect Schedule, functional ability (Perceived Motor-Efficacy Scale for Older Adults, quality of life (Short-Form (36 Health Survey version 2 and loneliness (UCLA Loneliness Scale were assessed. Focus groups with participants and semi-structured interviews with the research team captured their experiences of the intervention. The feasibility component of this trial examined recruitment via primary care and retention of participants, appropriateness of the intervention for older adults and the delivery of the intervention by a practice nurse. Discussion West End Walkers 65+ will determine the feasibility and pilot the efficacy of delivering a pedometer-based walking intervention through primary care to Scottish adults aged ≥65 years. The study will also

  6. Italian survey on cardiac rehabilitation and secondary prevention after cardiac revascularization: ICAROS study. A survey from the Italian cardiac rehabilitation network: rationale and design.

    Griffo, Raffaele; Fattirolli, Francesco; Temporelli, Pier Luigi; Tramarin, Roberto

    2008-09-01

    In this paper, the Italian Association for Cardiac Prevention and Rehabilitation (GICR) presents the rationale and design of the "Italian survey on CArdiac RehabilitatiOn and Secondary prevention after cardiac revascularization (ICAROS)". The survey is a prospective, longitudinal, multicentric survey, with a on-line web-based data collection. Its design corresponds to the survey's goal, i.e. to describe accurately in the Italian cardiological setting, through a representative number of cardiac rehabilitation centers belonging to the GICR national network, the characteristics, content and effects in the medium term of cardiac rehabilitation (CRP) inpatient or outpatient programs offered to patients after coronary artery bypass (CABG) or percutaneous revascularization (PTCA). The primary aims of the study are: a) to define the principal clinical characteristics of patients who have undergone PTCA or CABG and have been admitted to a CRP program; b) to identify the components of the CRP programs in terms of diagnostic procedures and assessment tests performed, treatments administered, educational programs and physical exercise interventions employed; c) to identify and analyze drug treatments prescribed at discharge from the acute facility and those prescribed at the end of the CRP program; d) to verify the clinical outcome during the course of the CRP program and at 6 months and 1 year after the end of the post-acute CRP program, as well as patients' adherence to the prescribed pharmacological therapy and to the recommended life styles, and the achievement and maintenance of the targets in relation to the modifiable risk factors; e) to define the consumption of major healthcare resources (major cardiac events, hospital re-admission, emergency care access, specialist visits) during the first year following a CRP program. The survey population will consist of all patients consecutively discharged in the period November 3-30, 2008 at the end of an inpatient, day

  7. Atraumatic extractions: a biomechanical rationale.

    Misch, Carl E; Perez, Helena M

    2008-08-01

    Biomechanical aspects of force have been applied to tooth extraction for centuries. However, the mechanical advantages available to extract the teeth were primarily applied to hold the crown of the tooth, rather than help extract it. An extraction device (Physics Forceps) has been developed to apply a biomechanical rationale to the extraction process of a tooth using a class 1 lever, creep, and shear components of force. PMID:18717405

  8. Rationale and Roadmap for Moon Exploration

    Foing, B. H.; ILEWG Team

    We discuss the different rationale for Moon exploration. This starts with areas of scientific investigations: clues on the formation and evolution of rocky planets, accretion and bombardment in the inner solar system, comparative planetology processes (tectonic, volcanic, impact cratering, volatile delivery), records astrobiology, survival of organics; past, present and future life. The rationale includes also the advancement of instrumentation: Remote sensing miniaturised instruments; Surface geophysical and geochemistry package; Instrument deployment and robotic arm, nano-rover, sampling, drilling; Sample finder and collector. There are technologies in robotic and human exploration that are a drive for the creativity and economical competitivity of our industries: Mecha-electronics-sensors; Tele control, telepresence, virtual reality; Regional mobility rover; Autonomy and Navigation; Artificially intelligent robots, Complex systems, Man-Machine interface and performances. Moon-Mars Exploration can inspire solutions to global Earth sustained development: In-Situ Utilisation of resources; Establishment of permanent robotic infrastructures, Environmental protection aspects; Life sciences laboratories; Support to human exploration. We also report on the IAA Cosmic Study on Next Steps In Exploring Deep Space, and ongoing IAA Cosmic Studies, ILEWG/IMEWG ongoing activities, and we finally discuss possible roadmaps for robotic and human exploration, starting with the Moon-Mars missions for the coming decade, and building effectively on joint technology developments.

  9. Firms' Rationales for Interaction with Research Universities

    Broström, Anders

    2008-01-01

    R&D managers at 50 firms randomly selected from all firms who have formal relations with two research universities in Stockholm are being interviewed about their rationales for collaboration. Drawing on this material, a distinctive typology of rationales and the therewith associated effects from cooperative relations is presented. As expected, rationales related to innovation, in terms of invented or improved products or processes, are found to be the main drivers for interaction. As regards ...

  10. Enhancing field GP engagement in hospital-based studies. Rationale, design, main results and participation in the diagest 3-GP motivation study

    Berkhout Christophe

    2012-06-01

    Full Text Available Abstract Background Diagest 3 was a study aimed at lowering the risk of developing type 2 diabetes within 3 years after childbirth. Women with gestational diabetes were enrolled in the study. After childbirth, the subjects showed little interest in the structured education programme and did not attend workshops. Their general practitioners (GPs were approached to help motivate the subjects to participate in Diagest 3, but the GPs were reluctant. The present study aimed to understand field GPs’ attitudes towards hospital-based studies, and to develop strategies to enhance their involvement and reduce subject drop-out rates. Methods We used a three-step process: step one used a phenomenological approach exploring the beliefs, attitudes, motivations and environmental factors contributing to the GPs’ level of interest in the study. Data were collected in face-to-face interviews and coded by hand and with hermeneutic software to develop distinct GP profiles. Step two was a cross-sectional survey by questionnaire to determine the distribution of the profiles in the GP study population and whether completion of an attached case report form (CRF was associated with a particular GP profile. In step three, we assessed the impact of the motivation study on participation rates in the main study. Results Fifteen interviews were conducted to achieve data saturation. Theorisation led to the definition of 4 distinct GP profiles. The response rate to the questionnaire was 73%, but dropped to 52% when a CRF was attached. The link between GP profiles and the rate of CRF completion remains to be verified. The GPs provided data on the CRF that was of comparable quality to those collected in the main trial. Our analysis showed that the motivation study increased overall participation in the main study by 23%, accounting for 16% (24/152 of all final visits for 536 patients who were initially enrolled in the Diagest 3 study. Conclusions When a hospital-led study

  11. Rationale, design, and method of the Diabetes & Women's Health study – a study of long-term health implications of glucose intolerance in pregnancy and their determinants

    Zhang, Cuilin; Hu, Frank B; Olsen, Sjurdur F;

    2014-01-01

    diabetes mellitus in two existing prospective cohorts, the Nurses' Health Study II and the Danish National Birth Cohort. Women who had a medical history of gestational diabetes mellitus in one or more of their pregnancies are eligible for the present study. After enrollment, we follow study participants...... public health interventions in relation to the transition of gestational diabetes mellitus to type 2 diabetes mellitus. To achieve the goal efficiently, we are applying a hybrid design enrolling and collecting data longitudinally from approximately 4000 women with a medical history of gestational...

  12. Meeting a Moral Imperative: A Rationale for Teaching the Holocaust

    Lindquist, David H.

    2011-01-01

    A primary rationale for studying the Holocaust (Shoah) involves the opportunity to consider the moral implications that can be drawn from examining the event. Studying the Shoah forces students to consider what it means to be human and humane by examining the full continuum of individual behavior, from "ultimate evil" to "ultimate good". This…

  13. Clinical Evaluation of Effects of Chronic Resveratrol Supplementation on Cerebrovascular Function, Cognition, Mood, Physical Function and General Well-Being in Postmenopausal Women—Rationale and Study Design

    Hamish Michael Evans

    2016-03-01

    Full Text Available Background: This methodological paper presents both a scientific rationale and a methodological approach for investigating the effects of resveratrol supplementation on mood and cognitive performance in postmenopausal women. Postmenopausal women have an increased risk of cognitive decline and dementia, which may be at least partly due to loss of beneficial effects of estrogen on the cerebrovasculature. We hypothesise that resveratrol, a phytoestrogen, may counteract this risk by enhancing cerebrovascular function and improving regional blood flow in response to cognitive demands. A clinical trial was designed to test this hypothesis. Method: Healthy postmenopausal women were recruited to participate in a randomised, double-blind, placebo-controlled (parallel comparison dietary intervention trial to evaluate the effects of resveratrol supplementation (75 mg twice daily on cognition, cerebrovascular responsiveness to cognitive tasks and overall well-being. They performed the following tests at baseline and after 14 weeks of supplementation: Rey Auditory Verbal Learning Test, Cambridge Semantic Memory Battery, the Double Span and the Trail Making Task. Cerebrovascular function was assessed simultaneously by monitoring blood flow velocity in the middle cerebral arteries using transcranial Doppler ultrasound. Conclusion: This trial provides a model approach to demonstrate that, by optimising circulatory function in the brain, resveratrol and other vasoactive nutrients may enhance mood and cognition and ameliorate the risk of developing dementia in postmenopausal women and other at-risk populations.

  14. A Community-Based Intervention to Prevent Obesity Beginning at Birth among American Indian Children: Study Design and Rationale for the PTOTS Study

    Karanja, Njeri; Aickin, Mikel; Lutz, Tam; Mist, Scott; Jobe, Jared B.; Maupome, Gerardo; Ritenbaugh, Cheryl

    2012-01-01

    Eating and physical activity behaviors associated with adult obesity have early antecedents, yet few studies have focused on obesity prevention interventions targeting very young children. Efforts to prevent obesity beginning at birth seem particularly important in populations at risk for early-onset obesity. National estimates indicate that…

  15. A randomized controlled trial of long term effect of BCM guided fluid management in MHD patients (BOCOMO study: rationales and study design

    Liu Li

    2012-09-01

    Full Text Available Abstract Background Bioimpedance analysis (BIA has been reported as helpful in identifying hypervolemia. Observation data showed that hypervolemic maintenance hemodialysis (MHD patients identified using BIA methods have higher mortality risk. However, it is not known if BIA-guided fluid management can improve MHD patients’ survival. The objectives of the BOCOMO study are to evaluate the outcome of BIA guided fluid management compared with standard care. Methods This is a multicenter, prospective, randomized, controlled trial. More than 1300 participants from 16 clinical sites will be included in the study. The enrolment period will last 6 months, and minimum length of follow-up will be 36 months. MHD patients aged between 18 years and 80 years who have been on MHD for at least 3 months and meet eligibility criteria will be invited to participate in the study. Participants will be randomized to BIA arm or control arm in a 1:1 ratio. A portable whole body bioimpedance spectroscopy device (BCM—Fresenius Medical Care D GmbH will be used for BIA measurement at baseline for both arms of the study. In the BIA arm, additional BCM measurements will be performed every 2 months. The primary intent-to-treat analysis will compare outcomes for a composite endpoint of death, acute myocardial infarction, stroke or incident peripheral arterial occlusive disease between groups. Secondary endpoints will include left ventricular wall thickness, blood pressure, medications, and incidence and length of hospitalization. Discussions Previous results regarding the benefit of strict fluid control are conflicting due to small sample sizes and unstable dry weight estimating methods. To our knowledge this is the first large-scale, multicentre, prospective, randomized controlled trial to assess whether BIS-guided volume management improves outcomes of MHD patients. The endpoints of the BOCOMO study are of utmost importance to health care providers. In order to obtain

  16. Psychological and personality factors in type 2 diabetes mellitus, presenting the rationale and exploratory results from The Maastricht Study: A population-based cohort study

    van Dooren, F.E.P.; Denollet, J; Verhey, F.R.J.; Stehouwer, C.D.; Sep, S.J.S.; Henry, R.M.; Kremers, S. P. J.; Dagnelie, P C; Schaper, N. C.; van der Kallen, C. J. H.; Koster, A.; Pouwer, F.; Schram, M T

    2016-01-01

    Background Strong longitudinal evidence exists that psychological distress is associated with a high morbidity and mortality risk in type 2 diabetes. Little is known about the biological and behavioral mechanisms that may explain this association. Moreover, the role of personality traits in these associations is still unclear. In this paper, we first describe the design of the psychological part of The Maastricht Study that aims to elucidate these mechanisms. Next, we present exploratory resu...

  17. A Community-Based Intervention to Prevent Obesity Beginning at Birth among American Indian Children: Study Design and Rationale for the PTOTS study

    Karanja, Njeri; Aickin, Mikel; Lutz, Tam; Mist, Scott; JOBE, Jared B.; Maupomé, Gerardo; Ritenbaugh, Cheryl

    2012-01-01

    Eating and physical activity behaviors associated with adult obesity have early antecedents, yet few studies have focused on obesity prevention interventions targeting very young children. Efforts to prevent obesity beginning at birth seem particularly important in populations at risk for early-onset obesity. National estimates indicate that American Indian (AI) children have higher rates of overweight and obesity than children of other races/ethnicities. The Prevention of Toddler Obesity and...

  18. Yoga as a complementary treatment for smoking cessation: rationale, study design and participant characteristics of the Quitting-in-Balance study

    Jennings Ernestine

    2010-04-01

    Full Text Available Abstract Background Tobacco smoking remains the leading preventable cause of death among American women. Exercise has shown promise as an aid to smoking cessation because it reduces weight gain and weight concerns, improves affect, and reduces nicotine withdrawal symptoms and cigarette craving. Studies have shown that the practice of yoga improves weight control, and reduces perceived stress and negative affect. Yoga practice also includes regulation of breathing and focused attention, both of which may enhance stress reduction and improve mood and well-being and may improve cessation outcomes. Methods/Design This pilot efficacy study is designed to examine the rates of cessation among women randomized to either a novel, 8-week Yoga plus Cognitive Behavioral Therapy (CBT smoking cessation intervention versus a Wellness program plus the same CBT smoking cessation intervention. Outcome measures include 7-day point prevalence abstinence at end of treatment, 3 and 6 months follow up and potential mediating variables (e.g., confidence in quitting smoking, self-efficacy. Other assessments include measures of mindfulness, spirituality, depressive symptoms, anxiety and perceived health (SF-36. Discussion Innovative treatments are needed that address barriers to successful smoking cessation among men and women. The design chosen for this study will allow us to explore potential mediators of intervention efficacy so that we may better understand the mechanism(s by which yoga may act as an effective complementary treatment for smoking cessation. If shown to be effective, yoga can offer an alternative to traditional exercise for reducing negative symptoms that often accompany smoking cessation and predict relapse to smoking among recent quitters. Trial Registration ClinicalTrials NCT00492310

  19. Enhancing physical and social environments to reduce obesity among public housing residents: rationale, trial design, and baseline data for the Healthy Families study.

    Quintiliani, Lisa M; DeBiasse, Michele A; Branco, Jamie M; Bhosrekar, Sarah Gees; Rorie, Jo-Anna L; Bowen, Deborah J

    2014-11-01

    Intervention programs that change environments have the potential for greater population impact on obesity compared to individual-level programs. We began a cluster randomized, multi-component multi-level intervention to improve weight, diet, and physical activity among low-socioeconomic status public housing residents. Here we describe the rationale, intervention design, and baseline survey data. After approaching 12 developments, ten were randomized to intervention (n=5) or assessment-only control (n=5). All residents in intervention developments are welcome to attend any intervention component: health screenings, mobile food bus, walking groups, cooking demonstrations, and a social media campaign; all of which are facilitated by community health workers who are residents trained in health outreach. To evaluate weight and behavioral outcomes, a subgroup of female residents and their daughters age 8-15 were recruited into an evaluation cohort. In total, 211 households completed the survey (RR=46.44%). Respondents were Latino (63%), Black (24%), and had ≤ high school education (64%). Respondents reported ≤2 servings of fruits & vegetables/day (62%), visiting fast food restaurants 1+ times/week (32%), and drinking soft drinks daily or more (27%). The only difference between randomized groups was race/ethnicity, with more Black residents in the intervention vs. control group (28% vs. 19%, p=0.0146). Among low-socioeconomic status urban public housing residents, we successfully recruited and randomized families into a multi-level intervention targeting obesity. If successful, this intervention model could be adopted in other public housing developments or entities that also employ community health workers, such as food assistance programs or hospitals. PMID:25139728

  20. Effectiveness of Oral Nutritional Supplementation for Older Women after a Fracture: Rationale, Design and Study of the Feasibility of a Randomized Controlled Study

    Lockwood Keri A

    2011-06-01

    Full Text Available Abstract Background Malnutrition is a problem for many older people recovering from a hip and other major fractures. Oral supplementation with high calorie high protein nutrients is a simple intervention that may help older people with fractures to improve their recovery in terms of rehabilitation time, length of hospital stay and mortality. This paper reports a pilot study to test the feasibility of a trial initiated in a hospital setting with an oral supplement to older people with recent fractures. Method A randomized controlled trial with 44 undernourished participants admitted to a hospital following a fracture. The intervention group (n = 23 received a high calorie high protein supplement for forty days in addition to their diet of choice. The control group (n = 21 received high protein milk during their hospital stay in addition to their diet of choice and their usual diet when discharged from hospital. Results All participants were women and their mean age was 85.3 (± 6.1 years. Twenty nine (65% participants had a hip fracture. At baseline no differences were measured between the two groups regarding their nutritional status, their cognitive ability or their abilities in activities of daily living. There were no significant differences between the intervention and control group with reference to nutritional or functional parameters at 40 day and 4 month follow-ups. Median length of stay in hospital was 18.0 days, with 12 participants being readmitted for a median of 7.0 days. Conclusion It is feasible to perform a randomised trial in a hospital and community setting to test the effect of an oral high energy high protein supplement for older people. Due to the limited number of participants and incomplete adherence with use of the supplements no conclusion can be drawn about the efficacy or effectiveness of this intervention.

  1. Rationales behind the choice of administration form with fentanyl

    Jacobsen, Ramune; Møldrup, Claus; Christrup, Lona

    2010-01-01

    BACKGROUND AND AIM: The aim of this study was to describe the rationale behind the choice of fentanyl administration forms among Danish general practitioners (GPs). METHODS: Thirty-eight Danish GPs were contacted via an Internet survey system to perform a Delphi survey. In the brainstorming phase...

  2. A Rationale for Mixed Methods (Integrative) Research Programmes in Education

    Niaz, Mansoor

    2008-01-01

    Recent research shows that research programmes (quantitative, qualitative and mixed) in education are not displaced (as suggested by Kuhn) but rather lead to integration. The objective of this study is to present a rationale for mixed methods (integrative) research programs based on contemporary philosophy of science (Lakatos, Giere, Cartwright,…

  3. Bioethics: A Rationale and a Model

    Barman, Charles R.; Rusch, John J.

    1978-01-01

    Discusses the rationale for and development of an undergraduate bioethics course. Based on experiences with the course, general suggestions are offered to instructors planning to add bioethics to existing curricula. (MA)

  4. Rationales for corporate risk management from stakeholders’ perspective

    Klimczak, Karol Marek

    2005-01-01

    The rationales for corporate risk management are examined from the point of view of the theory of finance and of key stakeholder groups’ interests. A study of the use of hedging instruments in 161 Polish non-financial listed companies is then presented. The study is based on keyword analysis of financial statements; parametric tests and logit regression are used to determine relationships between the hedging decision and financial standing of companies. However, company size is proved to be t...

  5. [Microbiological rationale for using whey on salting salmon caviar].

    Kim, I N; Shtan'ko, T I

    2011-01-01

    The paper provides a rationale for the use of whey to salt salmon fishes instead of traditional preservatives, including those exported from low industrial potential countries, which do not undergo comprehensive sanitary and hygienic tests. On the basis of the performed studies, the authors recommend to use whey to salt salmon caviar, which ensures the ecological purity of the product containing the minimum amount of preservatives and other substances that fail to affect its organoleptic properties. PMID:21598650

  6. Exploring the rationale of the process behind corporate sponsorships

    Ystad, Sunniva G. Marchioro; Nygaard, Kaja Gjersem

    2012-01-01

    The purpose of this thesis was to examine and identify the process behind the delegation of corporate sponsorships in a Norwegian context. Corporate sponsorships are presently the third largest corporate communication channel in Norway. However, there is limited research on sponsorship management. The thesis seeks to identify the process and investigate the rationale behind it. To be able to research this, an explorative study was conducted, by means of a grounded theory design. First, a m...

  7. Adoption of managerial innovations: effect of adoption rationales on the adoption process

    Daniel, Elizabeth Mary; Myers, Andrew; Dixon, Keith

    2008-01-01

    The aim of the research is to explore the complex phenomenon of the adoption of managerial innovations by organisations, with an attempt to identify relationships between various elements of this process. Four case studies were compiled using interview data from selected managers. The data provided a means of subjecting the rationales that Sturdy (2004) posited for the adoption of managerial innovations to empirical inquiry. The study also seeks to explore how the identified rationales may...

  8. Predicting the outcome of chronic kidney disease by the estimated nephron number: The rationale and design of PRONEP, a prospective, multicenter, observational cohort study

    Imasawa Toshiyuki

    2012-03-01

    Full Text Available Abstract Background The nephron number is thought to be associated with the outcome of chronic kidney disease (CKD. If the nephron number can be estimated in the clinical setting, it could become a strong tool to predict renal outcome. This study was designed to estimate the nephron number in CKD patients and to establish a method to predict the outcome by using the estimated nephron number. Methods/Design The hypothesis of this study is that the estimated nephron number can predict the outcome of a CKD patient. This will be a multicenter, prospective (minimum 3 and maximum 5 years follow-up study. The subjects will comprise CKD patients aged over 14 years who have undergone a kidney biopsy. From January 2011 to March 2013, we will recruit 600 CKD patients from 10 hospitals belonging to the National Hospital Organization of Japan. The primary parameter for assessment is the composite of total mortality, renal death, cerebro-cardiovascular events, and a 50% reduction in the eGFR. The secondary parameter is the rate of eGFR decline per year. The nephron number will be estimated by the glomerular density in biopsy specimens and the renal cortex volume. This study includes one sub-cohort study to establish the equation to calculate the renal cortex volume. Enrollment will be performed at the time of the kidney biopsy, and the data will consist of a medical interview, ultrasound for measurement of the kidney size, blood or urine test, and the pathological findings of the kidney biopsy. Patients will continue to have medical consultations and receive examinations and/or treatment as usual. The data from the patients will be collected once a year after the kidney biopsy until March 2016. All data using this study are easily obtained in routine clinical practice. Discussion This study includes the first trials to estimate the renal cortex volume and nephron number in the general clinical setting. Furthermore, this is the first prospective study to

  9. Kelston Beverages Pilot Study: Rationale, design and implementation of a community and school based intervention to reduce sugary drink consumption among children and youth.

    Sundborn, G; Ni Mhurchu, C; Ness, C; Latu, H; Jackson, R

    2014-03-01

    The Kelston Beverages Study was designed to increase awareness of the sugar content of sugary drinks, the poor health consequences that high intake of these drinks have, and inform on ways to reduce intake of students. The aims of this pilot study were to refine interventions and processes designed to raise awareness of the harms that sugar sweetened beverages (SSBs) have on health, and to reduce their consumption among the youth of a small West Auckland suburb. There were three arms to this interventional study, one in schools, another in community organisations (churches, sports clubs and community groups), and the final arm is in the local retail sector. The school arm was the most extensive component and initially involved a survey of children's knowledge and consumption of sugar sweetened beverages (SSBs) using a brief questionnaire. The study evaluated any SSB policies in schools and for schools that did not have policies, opportunities were scoped to develop and implement them; a canteen AUDIT focussed particularly on beverages was carried out; and finally a student partnered social marketing exercise was undertaken that comprised 2 competitions, one to design a poster, and another to write and perform a rap. Children were re-surveyed at the completion of the intervention (7 months later) to determine change in knowledge and self-reported consumption of SSBs. Both the community organisations and retail arms of this study focussed on raising awareness into the harmful effects of SSBs and establishing healthy beverage policy in the respective organisations. Promising results with regards to acceptability, feasibility, and recruitment as well as valuable learnings with regard to process support the development of a proposal to conduct a cluster randomised trial of the interventions successfully tested in this pilot study. PMID:25929003

  10. Determinants of cardiovascular disease and other non-communicable diseases in Central and Eastern Europe: Rationale and design of the HAPIEE study

    Pikhart Hynek

    2006-10-01

    Full Text Available Abstract Background Over the last five decades, a wide gap in mortality opened between western and eastern Europe; this gap increased further after the dramatic fluctuations in mortality in the former Soviet Union (FSU in the 1990s. Recent rapid increases in mortality among lower socioeconomic groups in eastern Europe suggests that socioeconomic factors are powerful determinants of mortality in these populations but the more proximal factors linking the social conditions with health remain unclear. The HAPIEE (Health, Alcohol and Psychosocial factors In Eastern Europe study is a prospective cohort study designed to investigate the effect of classical and non-conventional risk factors and social and psychosocial factors on cardiovascular and other non-communicable diseases in eastern Europe and the FSU. The main hypotheses of the HAPIEE study relate to the role of alcohol, nutrition and psychosocial factors. Methods and design The HAPIEE study comprises four cohorts in Russia, Poland, the Czech Republic and Lithuania; each consists of a random sample of men and women aged 45–69 years old at baseline, stratified by gender and 5 year age groups, and selected from population registers. The total planned sample size is 36,500 individuals. Baseline information from the Czech Republic, Russia and Poland was collected in 2002–2005 and includes data on health, lifestyle, diet (food frequency, socioeconomic circumstances and psychosocial factors. A short examination included measurement of anthropometric parameters, blood pressure, lung function and cognitive function, and a fasting venous blood sample. Re-examination of the cohorts in 2006–2008 focuses on healthy ageing and economic well-being using face-to-face computer assisted personal interviews. Recruitment of the Lithuanian cohort is ongoing, with baseline and re-examination data being collected simultaneously. All cohorts are being followed up for mortality and non-fatal cardiovascular

  11. Predicting cardiovascular disease morbidity and mortality in chronic kidney disease in Spain. The rationale and design of NEFRONA: a prospective, multicenter, observational cohort study

    Roig Jordi

    2010-07-01

    Full Text Available Abstract Background Cardiovascular disease (CVD is the leading cause of morbidity and mortality in patients with chronic kidney disease (CKD. Cardiovascular risk assessment in this population is hampered by the failure of traditional risk factors to fully account for the elevated CVD risk (reverse epidemiology effect and the presence of emerging risk factors specifically related to kidney failure. Therefore, diagnostic tools capable of improving cardiovascular risk assessment beyond traditional risk factors are currently warranted. We present the protocol of a 4-year prospective study aimed to assess the predictive value of non-invasive imaging techniques and biomarkers for CVD events and mortality in patients with CKD. Methods From November 2009 to October 2010, 4137 asymptomatic adult patients with stages 2 to 5 CKD will be recruited from nephrology services and dialysis units throughout Spain. During the same period, 843 participants without CKD (control group will be recruited from lists of primary care physicians, only at baseline. During the follow-up, CVD events and mortality will be recorded from all CKD patients. Clinical and laboratory characteristics will be collected in a medical documentation sheet. Three trained itinerant teams will carry out a carotid ultrasound to assess intima-media thickness and presence of plaques. A composite atherosclerosis score will be constructed based on carotid ultrasound data and measurement of ankle-brachial index. In CKD patients, presence and type of calcifications will be assessed in the wall of carotid, femoral and brachial arteries, and in cardiac valves, by ultrasound. From all participants, blood samples will be collected and stored in a biobank to study novel biomarkers. Conclusions The NEFRONA study is the first large, prospective study to examine the predictive value of several non-invasive imaging techniques and novel biomarkers in CKD patients throughout Spain. Hereby, we present the

  12. Preventing AVF thrombosis: the rationale and design of the Omega-3 fatty acids (Fish Oils and Aspirin in Vascular access OUtcomes in REnal Disease (FAVOURED study

    Rosman Johan

    2009-01-01

    Full Text Available Abstract Background Haemodialysis (HD is critically dependent on the availability of adequate access to the systemic circulation, ideally via a native arteriovenous fistula (AVF. The Primary failure rate of an AVF ranges between 20–54%, due to thrombosis or failure of maturation. There remains limited evidence for the use of anti-platelet agents and uncertainty as to choice of agent(s for the prevention of AVF thrombosis. We present the study protocol for a randomised, double-blind, placebo-controlled, clinical trial examining whether the use of the anti-platelet agents, aspirin and omega-3 fatty acids, either alone or in combination, will effectively reduce the risk of early thrombosis in de novo AVF. Methods/Design The study population is adult patients with stage IV or V chronic kidney disease (CKD currently on HD or where HD is planned to start within 6 months in whom a planned upper or lower arm AVF is to be the primary HD access. Using a factorial-design trial, patients will be randomised to aspirin or matching placebo, and also to omega-3 fatty acids or matching placebo, resulting in four treatment groups (aspirin placebo/omega-3 fatty acid placebo, aspirin/omega-3 fatty acid placebo, aspirin placebo/omega-3 fatty acid, aspirin/omega-3 fatty acid. Randomisation will be achieved using a dynamic balancing method over the two stratification factors of study site and upper versus lower arm AVF. The medication will be commenced pre-operatively and continued for 3 months post surgery. The primary outcome is patency of the AVF at three months after randomisation. Secondary outcome measures will include functional patency at six and twelve months, primary patency time, secondary (assisted patency time, and adverse events, particularly bleeding. Discussion This multicentre Australian and New Zealand study has been designed to determine whether the outcome of surgery to create de novo AVF can be improved by the use of aspirin and/or omega-3 fatty

  13. Ultrasound enhanced prehospital thrombolysis using microbubbles infusion in patients with acute ST elevation myocardial infarction: Rationale and design of the Sonolysis study

    van Dijk Arie PJ

    2008-12-01

    Full Text Available Abstract Background - Experimental studies have shown that ultrasound contrast agents enhance the effectiveness of thrombolytic agents in the presence of ultrasound in vitro and in vivo. Recently, we have launched a clinical pilot study, called "Sonolysis", to study this effect in patients with ST-elevation myocardial infarction based on proximal lesions of the infarct-related artery. Methods/design - In our multicenter, randomized, placebo controlled clinical trial we will include patients between 18 and 80 years of age with their first ST-elevation myocardial infarction based on a proximal lesion of the infarct-related artery. After receiving a single bolus alteplase 50 mg IV (Actilyse® Boehringer Ingelheim GmbH, a loading dose of aspirin 500 mg, and heparin 5000 IU in the ambulance according to the prehospital thrombolysis protocol, patients, following oral informed consent, are randomized to undergo 15 minutes of pulsatile ultrasound with intravenous administration of ultrasound contrast agent or placebo without ultrasound. Afterwards coronary angiography and, if indicated, percutaneous coronary intervention will take place. A total of 60 patients will be enrolled in approximately 1 year. The primary endpoints are based on the coronary angiogram and consist of TIMI flow, corrected TIMI frame count, and myocardial blush grade. Follow-up includes 12-lead ECG, 2D-echocardiography, cardiac MRI, and enzyme markers to obtain our secondary endpoints, including the infarct size, wall motion abnormalities, and the global left ventricular function. Discussion - The Sonolysis study is the first multicenter, randomized, placebo controlled clinical trial investigating the therapeutic application of ultrasound and microbubbles in acute ST-elevation myocardial infarction patients. A positive finding may stimulate further research and technical innovations to implement the treatment in the ambulance and maybe obtain even more patency at an earlier stage

  14. Rationale, design and methods for the 22 year follow-up of the Western Australian Pregnancy Cohort (Raine) Study

    Straker, Leon M; Hall, Graham L.; Mountain, Jenny; Howie, Erin K.; White, Elisha; McArdle, Nigel; Eastwood, Peter R.; ,

    2015-01-01

    Background Young adulthood is a critical life period for health and health behaviours. Related measurements collected before and after birth, and during childhood and adolescence can provide a life-course analysis of important factors that contribute to health and behaviour in young adulthood. The Western Australian Pregnancy Cohort (Raine) Study has collected a large number of such measurements during the fetal, perinatal, infancy, childhood and adolescence periods and plans to relate them t...

  15. Rationale and study design of PROVHILO - a worldwide multicenter randomized controlled trial on protective ventilation during general anesthesia for open abdominal surgery

    Hedenstierna Göran; Binnekade Jan M; Hollmann Markus W; Tschernko Edda M; Hiesmayr Michael; Wrigge Hermann; Canet Jaume; Jaber Samir; Severgnini Paolo; Hemmes Sabrine NT; Putensen Christian; Abreu Marcelo; Pelosi Paolo; Schultz Marcus J

    2011-01-01

    Abstract Background Post-operative pulmonary complications add to the morbidity and mortality of surgical patients, in particular after general anesthesia >2 hours for abdominal surgery. Whether a protective mechanical ventilation strategy with higher levels of positive end-expiratory pressure (PEEP) and repeated recruitment maneuvers; the "open lung strategy", protects against post-operative pulmonary complications is uncertain. The present study aims at comparing a protective mechanical ven...

  16. Cognitive function after cardiac arrest and temperature management; rationale and description of a sub-study in the Target Temperature Management trial

    Lilja, Gisela; Nielsen, Niklas; Friberg, Hans;

    2013-01-01

    Mild to moderate cognitive impairment is common amongst long-term survivors of cardiac arrest. In the Target Temperature Management trial (TTM-trial) comatose survivors were randomized to 33°C or 36°C temperature control for 24 hours after cardiac arrest and the effects on survival and neurological...... outcome assessed. This protocol describes a sub-study of the TTM-trial investigating cognitive dysfunction and its consequences for patients' and relatives' daily life....

  17. [Atherosclerosis of the lower extremities as a linked comorbidity in Patients Admitted for cardiac rehabilitation (THINKPAD): rationale, design, and study group].

    Ambrosetti, Marco; Diaco, Tommaso; Febo, Oreste; Calisi, Pasqualina; Favretto, Giuseppe; Carlon, Roberto; Temporelli, Pier Luigi

    2012-03-01

    Peripheral arterial disease (PAD) is a frequent comorbidity among patients entering cardiac rehabilitation (CR) programmes and an important source of disability and impaired prognosis. The prevalence of PAD across the wide range of conditions for CR is poorly understood, as far as its impact on drug optimization and intervention delivered. The "ATHerosclerosis of the lower extremities as a liNKed comorbidity in Patients Admitted for carDiac rehabilitation" (THINKPAD) study was carried out by the Italian Association for Cardiovascular Prevention, Rehabilitation and Epidemiology (GICR-IACPR) in order to explore PAD both as a comorbidity and a primary indication at the entry of CR. The study was a retrospective case series. In the study period (from May 1, 2012 to June 30, 2012), data on consecutive patients discharged from 17 CR units in Northern Italy were collected. Web-based electronic case report forms (e-CRF), accessible in a dedicated section of the IACPR website (www.iacpr.it), were used for data entry, and data were transferred via web to a central database. The data collection instrument was designed with a multiple choice format, with jump menus or select boxes and obligatory items. A sample size of 1,300 subjects is expected, with first data available by the end of 2012. PMID:22928398

  18. Rationale, design, and cohort enrolment of a prospective observational study of the clinical performance of the new contraceptive implant (Femplant in Pakistan

    Azmat SK

    2014-05-01

    Full Text Available Syed Khurram Azmat,1 Waqas Hameed,1 Anja Lendvay,2 Babar Tasneem Shaikh,3 Ghulam Mustafa,1 Muhammad Ahmed Siddiqui,1 Sajid Brohi,1 Asif Karim,1 Muhammad Ishaque,1 Wajahat Hussain,1 Mohsina Bilgrami,1 Paul J Feldblum2 1Research, Monitoring and Evaluation Department, Marie Stopes Society, Karachi, Pakistan; 2FHI 360, Durham, NC, USA; 3Health Services Academy, Islamabad, Pakistan Introduction: The use of hormonal implants has gained positive traction in family planning programs in recent times. Compared to other popular methods, such as long-term reversible intrauterine devices, the use of hormonal implants as a family planning method has distinct advantages in terms of long-term efficiency and better user compliance and availability. This paper presents a study protocol to document and evaluate the efficacy, safety, and acceptability of Femplant (contraceptive implant in Pakistan during the first year of its use among married women of reproductive age (18–44 years at clinics in two provinces of Pakistan (Sindh and Punjab. Materials and methods: A total of 724 married women were enrolled in a noncomparative prospective observational study. The study involved six government clinics from the Population Welfare Department in Sindh Province and 13 clinics run by the Marie Stopes Society (a local nongovernmental organization in both provinces. The participation of women was subject to voluntary acceptance and medical eligibility. All respondents were interviewed at baseline and subsequently at each scheduled visit during the study period. Side effects, complications and adverse events, if any, were recorded for every participant at each visit to the facility. Discussion: Over the next 5-year period (2013–2018, 27 million hormonal implants will be made available in lower- to middle-income countries by international donors and agencies. The evidence generated from this study will identify factors affecting the acceptability and satisfaction of end

  19. The lung cancer exercise training study: a randomized trial of aerobic training, resistance training, or both in postsurgical lung cancer patients: rationale and design

    Crawford Jeffrey

    2010-04-01

    Full Text Available Abstract Background The Lung Cancer Exercise Training Study (LUNGEVITY is a randomized trial to investigate the efficacy of different types of exercise training on cardiorespiratory fitness (VO2peak, patient-reported outcomes, and the organ components that govern VO2peak in post-operative non-small cell lung cancer (NSCLC patients. Methods/Design Using a single-center, randomized design, 160 subjects (40 patients/study arm with histologically confirmed stage I-IIIA NSCLC following curative-intent complete surgical resection at Duke University Medical Center (DUMC will be potentially eligible for this trial. Following baseline assessments, eligible participants will be randomly assigned to one of four conditions: (1 aerobic training alone, (2 resistance training alone, (3 the combination of aerobic and resistance training, or (4 attention-control (progressive stretching. The ultimate goal for all exercise training groups will be 3 supervised exercise sessions per week an intensity above 70% of the individually determined VO2peak for aerobic training and an intensity between 60 and 80% of one-repetition maximum for resistance training, for 30-45 minutes/session. Progressive stretching will be matched to the exercise groups in terms of program length (i.e., 16 weeks, social interaction (participants will receive one-on-one instruction, and duration (30-45 mins/session. The primary study endpoint is VO2peak. Secondary endpoints include: patient-reported outcomes (PROs (e.g., quality of life, fatigue, depression, etc. and organ components of the oxygen cascade (i.e., pulmonary function, cardiac function, skeletal muscle function. All endpoints will be assessed at baseline and postintervention (16 weeks. Substudies will include genetic studies regarding individual responses to an exercise stimulus, theoretical determinants of exercise adherence, examination of the psychological mediators of the exercise - PRO relationship, and exercise-induced changes

  20. Who Should Benefit from REDD+? Rationales and Realities

    Cecilia Luttrell

    2013-12-01

    Full Text Available Benefit-sharing mechanisms are a central design aspect of REDD+ because they help to create the necessary incentives to reduce carbon emissions. However, if stakeholders do not perceive the benefit sharing as fair, the legitimacy of REDD+, and support for the mechanism, will be weakened. In this paper, drawing on data from CIFOR's Global Comparative Study on REDD+, we analyze national policy processes in 6 countries and incipient benefit-sharing arrangements in 21 REDD+ project sites. Through our analysis of current practices and debates, we identify six rationales that have been put forward to justify how benefits should be distributed and to whom. These rationales encompass a range of perspectives. Some hold that benefit sharing should be related to actual carbon emission reductions or to costs incurred in achieving the reduction of emissions; others emphasize the importance of a legal right to benefit, the need to consider aspects such as poverty reduction or the appropriateness of rewarding those with a history of protecting the forest. Each rationale has implications for the design of benefit-sharing mechanisms and the equity of their outcomes. We point out that, given the wide range of rationales and interests at play, the objectives of REDD+ and benefit sharing must be clearly established and the term "benefit" defined before effective benefit-sharing mechanisms can be designed. For stakeholders to support REDD+, the legitimacy of decision-making institutions, consideration of context, and attention to process are critical. Building legitimacy requires attention not only to fair distributional outcomes but also to consensus on relevant institutions' authority to make decisions and to procedural equity.

  1. PRevalence of Abuse and Intimate Partner Violence Surgical Evaluation (P.R.A.I.S.E.: rationale and design of a multi-center cross-sectional study.

    2010-04-01

    Full Text Available Abstract Background Intimate partner violence (IPV is described by the American Medical Association as "a pattern of coercive behaviors that may include repeated battering and injury, psychological abuse, sexual assault, progressive social isolation, deprivation, and intimidation." The long-term consequences of IPV include health risks, posttraumatic stress disorder, depression, and staggering economic costs for health care of victims. Intimate partner violence is often underreported among women who seek medical attention. The current study seeks to address the issue of possible underreporting of IPV in orthopaedic fracture clinics by establishing prevalence rates of IPV among women seeking treatment for musculoskeletal injuries. Methods/Design We propose a cross-sectional multicenter study wherein 3,600 women will complete a self-reported written questionnaire across clinical sites in North America, Europe, and Australia. Recruitment of participants will take place at orthopaedic fracture clinics at each clinical site. The questionnaire will contain a validated set of questions used to screen for IPV, as well as questions that pertain to the participant's demographic, injury characteristics, and experiences with health care utilization. Female patients presenting to the orthopaedic fracture clinics will complete two validated self-reported written questionnaires (Woman Abuse Screening Tool (WAST and the Partner Violence Screen (PVS to determine the prevalence of IPV in the past 12 months and in their lifetime. The two questionnaires were designed for rapid assessment of IPV status in emergency departments, family practice, and women's health clinics that we believe are similar to our intended setting of an orthopaedic clinic. Discussion If the prevalence of IPV among women attending orthopaedic clinics is greater than the current perceptions of orthopaedic surgeons, this study will serve to advocate for the continued education of medical

  2. A randomised controlled trial of an enhanced interdisciplinary community based group program for people with Parkinson’s disease: study rationale and protocol

    Catherine Peters

    2012-03-01

    Full Text Available Parkinson’s disease (PD is a progressive, chronic neurodegenerative disorder for which there is no known cure. Physical exercise programs may be used to assist with the physical management of PD. Several studies have demonstrated that community based physical therapy programs are effective in reducing physical aspects of disability among people with PD. While multidisciplinary therapy interventions may have the potential to reduce disability and improve the quality of life of people with PD, there is very limited clinical trial evidence to support or refute the use of a community based multidisciplinary or interdisciplinary programs for people with PD. A two group randomized trial is being undertaken within a community rehabilitation service in Brisbane, Australia. Community dwelling adults with a diagnosis of Idiopathic Parkinson’s disease are being recruited. Eligible participants are randomly allocated to a standard exercise rehabilitation group program or an intervention group which incorporates physical, cognitive and speech activities in a multi-tasking framework. Outcomes will be measured at 6-week intervals for a period of six months. Primary outcome measures are the Montreal Cognitive Assessment (MoCA and the Timed Up and Go (TUG cognitive test. Secondary outcomes include changes in health related quality of life, communication, social participation, mobility, strength and balance, and carer burden measures. This study will determine the immediate and long-term effectiveness of a unique multifocal, interdisciplinary, dual-tasking approach to the management of PD as compared to an exercise only program. We anticipate that the results of this study will have implications for the development of cost effective evidence based best practice for the treatment of people with PD living in the community.

  3. Rate of cardiac arrhythmias and silent brain lesions in experienced marathon runners: rationale, design and baseline data of the Berlin Beat of Running study

    Haeusler Karl

    2012-08-01

    Full Text Available Abstract Background Regular exercise is beneficial for cardiovascular health but a recent meta-analysis indicated a relationship between extensive endurance sport and a higher risk of atrial fibrillation, an independent risk factor for stroke. However, data on the frequency of cardiac arrhythmias or (clinically silent brain lesions during and after marathon running are missing. Methods/ Design In the prospective observational “Berlin Beat of Running” study experienced endurance athletes underwent clinical examination (CE, 3 Tesla brain magnetic resonance imaging (MRI, carotid ultrasound imaging (CUI and serial blood sampling (BS within 2-3 days prior (CE, MRI, CUI, BS, directly after (CE, BS and within 2 days after (CE, MRI, BS the 38th BMW BERLIN-MARATHON 2011. All participants wore a portable electrocardiogram (ECG-recorder throughout the 4 to 5 days baseline study period. Participants with pathological MRI findings after the marathon, troponin elevations or detected cardiac arrhythmias will be asked to undergo cardiac MRI to rule out structural abnormalities. A follow-up is scheduled after one year. Results Here we report the baseline data of the enrolled 110 athletes aged 36-61 years. Their mean age was 48.8 ± 6.0 years, 24.5% were female, 8.2% had hypertension and 2.7% had hyperlipidaemia. Participants have attended a mean of 7.5 ± 6.6 marathon races within the last 5 years and a mean of 16 ± 36 marathon races in total. Their weekly running distance prior to the 38th BMW BERLIN-MARATHON was 65 ± 17 km. Finally, 108 (98.2% Berlin Beat-Study participants successfully completed the 38th BMW BERLIN-MARATHON 2011. Discussion Findings from the “Berlin Beats of Running” study will help to balance the benefits and risks of extensive endurance sport. ECG-recording during the marathon might contribute to identify athletes at risk for cardiovascular events. MRI results will give new insights into the link

  4. Rationale, design and methodology of a double-blind, randomized, placebo-controlled study of escitalopram in prevention of Depression in Acute Coronary Syndrome (DECARD

    Hansen Jørgen

    2009-04-01

    Full Text Available Abstract Background The prevalence of depression in patients with acute coronary syndrome, i.e. myocardial infarction and unstable angina, is higher than in the general population. The prevalence of anxiety is higher as well. Both depression and anxiety are associated with poor cardiac outcomes and higher mortality. Comorbid depression in patients with acute coronary syndrome often goes undiagnosed, and it is therefore a challenging task to prevent this risk factor. The study of DEpression in Coronary ARtery Disease (DECARD is designed to examine if it is possible to prevent depression in patients with acute coronary syndrome. Methods Two hundred forty non-depressed patients with acute coronary syndrome are randomized to treatment with either escitalopram or placebo for 1 year. Psychiatric and cardiac assessment of patients is performed to evaluate the possibility of preventing depression. Diagnosis of depression and Hamilton Depression Scale are the primary outcome measures. Discussion This is the first study of prevention of depression in patients after acute coronary syndrome with a selective serotonin reuptake inhibitor. Trial Registration http://www.ClinicalTrials.gov. Identifier: NCT00140257

  5. Rationale and study design of PROVHILO - a worldwide multicenter randomized controlled trial on protective ventilation during general anesthesia for open abdominal surgery

    Hedenstierna Göran

    2011-05-01

    Full Text Available Abstract Background Post-operative pulmonary complications add to the morbidity and mortality of surgical patients, in particular after general anesthesia >2 hours for abdominal surgery. Whether a protective mechanical ventilation strategy with higher levels of positive end-expiratory pressure (PEEP and repeated recruitment maneuvers; the "open lung strategy", protects against post-operative pulmonary complications is uncertain. The present study aims at comparing a protective mechanical ventilation strategy with a conventional mechanical ventilation strategy during general anesthesia for abdominal non-laparoscopic surgery. Methods The PROtective Ventilation using HIgh versus LOw positive end-expiratory pressure ("PROVHILO" trial is a worldwide investigator-initiated multicenter randomized controlled two-arm study. Nine hundred patients scheduled for non-laparoscopic abdominal surgery at high or intermediate risk for post-operative pulmonary complications are randomized to mechanical ventilation with the level of PEEP at 12 cmH2O with recruitment maneuvers (the lung-protective strategy or mechanical ventilation with the level of PEEP at maximum 2 cmH2O without recruitment maneuvers (the conventional strategy. The primary endpoint is any post-operative pulmonary complication. Discussion The PROVHILO trial is the first randomized controlled trial powered to investigate whether an open lung mechanical ventilation strategy in short-term mechanical ventilation prevents against postoperative pulmonary complications. Trial registration ISRCTN: ISRCTN70332574

  6. Non-invasive cardiac assessment in high risk patients (The GROUND study: rationale, objectives and design of a multi-center randomized controlled clinical trial

    Moll Frans L

    2008-08-01

    Full Text Available Abstract Background Peripheral arterial disease (PAD is a common disease associated with a considerably increased risk of future cardiovascular events and most of these patients will die from coronary artery disease (CAD. Screening for silent CAD has become an option with recent non-invasive developments in CT (computed tomography-angiography and MR (magnetic resonance stress testing. Screening in combination with more aggressive treatment may improve prognosis. Therefore we propose to study whether a cardiac imaging algorithm, using non-invasive imaging techniques followed by treatment will reduce the risk of cardiovascular disease in PAD patients free from cardiac symptoms. Design The GROUND study is designed as a prospective, multi-center, randomized clinical trial. Patients with peripheral arterial disease, but without symptomatic cardiac disease will be asked to participate. All patients receive a proper risk factor management before randomization. Half of the recruited patients will enter the 'control group' and only undergo CT calcium scoring. The other half of the recruited patients (index group will undergo the non invasive cardiac imaging algorithm followed by evidence-based treatment. First, patients are submitted to CT calcium scoring and CT angiography. Patients with a left main (or equivalent coronary artery stenosis of > 50% on CT will be referred to a cardiologist without further imaging. All other patients in this group will undergo dobutamine stress magnetic resonance (DSMR testing. Patients with a DSMR positive for ischemia will also be referred to a cardiologist. These patients are candidates for conventional coronary angiography and cardiac interventions (coronary artery bypass grafting (CABG or percutaneous cardiac interventions (PCI, if indicated. All participants of the trial will enter a 5 year follow up period for the occurrence of cardiovascular events. Sequential interim analysis will take place. Based on sample size

  7. A randomized controlled trial of tai chi for long-term low back pain (TAI CHI: Study rationale, design, and methods

    Hall Amanda M

    2009-05-01

    Full Text Available Abstract Background Low back pain persisting for longer than 3 months is a common and costly condition for which many current treatments have low-moderate success rates at best. Exercise is among the more successful treatments for this condition, however, the type and dosage of exercise that elicits the best results is not clearly defined. Tai chi is a gentle form of low intensity exercise that uses controlled movements in combination with relaxation techniques and is currently used as a safe form of exercise for people suffering from other chronic pain conditions such as arthritis. To date, there has been no scientific evaluation of tai chi as an intervention for people with back pain. Thus the aim of this study will be to examine the effects of a tai chi exercise program on pain and disability in people with long-term low back pain. Methods and design The study will recruit 160 healthy individuals from the community setting to be randomised to either a tai chi intervention group or a wait-list control group. Individuals in the tai chi group will attend 2 tai chi sessions (40 minutes/week for 8 weeks followed by 1 tai chi session/week for 2 weeks. The wait-list control will continue their usual health care practices and have the opportunity to participate in the tai chi program once they have completed the follow-up assessments. The primary outcome will be bothersomeness of back symptoms measured with a 0–10 numerical rating scale. Secondary outcomes include, self-reports of pain-related disability, health-related quality of life and global perceived effect of treatment. Statistical analysis of primary and secondary outcomes will be based on the intention to treat principle. Linear mixed models will be used to test for the effect of treatment on outcome at 10 weeks follow up. This trial has received ethics approval from The University of Sydney Human Research Ethics Committee. HREC Approval No.10452 Discussion This study will be the first

  8. Discovery of biomarkers for glycaemic deterioration before and after the onset of type 2 diabetes: rationale and design of the epidemiological studies within the IMI DIRECT Consortium

    Koivula, Robert W.; Heggie, Alison; Barnett, Anna; Cederberg, Henna; Hansen, Tue Haldor; Koopman, Anitra D.; Ridderstrale, Martin; Rutters, Femke; Vestergaard, Henrik; Gupta, Ramneek; Herrgard, Sanna; Heymans, Martijn W.; Perry, Mandy H.; Rauh, Simone; Siloaho, Maritta; Teare, Harriet J. A.; Thorand, Barbara; Bell, Jimmy; Brunak, Søren; Frost, Gary; Jablonka, Bernd; Mari, Andrea; McDonald, Tim J.; Dekker, Jacqueline M.; Hansen, Torben; Hattersley, Andrew; Laakso, Markku; Pedersen, Oluf; Koivisto, Veikko; Ruetten, Hartmut; Walker, Mark; Pearson, Ewan; Franks, Paul W.

    2014-01-01

    Aims/hypothesis The DIRECT (Diabetes Research on Patient Stratification) Study is part of a European Union Framework 7 Innovative Medicines Initiative project, a joint undertaking between four industry and 21 academic partners throughout Europe. The Consortium aims to discover and validate......, urine and nail clippings, which, among other biochemical analyses, will be characterised at genetic, transcriptomic, metabolomic, proteomic and metagenomic levels. Lifestyle is assessed using high-resolution triaxial accelerometry, 24 h diet record, and food habit questionnaires. Conclusinos....../interpretation DIRECT will yield an unprecedented array of biomaterials and data. This resource, available through managed access to scientists within and outside the Consortium, will facilitate the development of new treatments and therapeutic strategies for the prevention and management of type 2 diabetes....

  9. Assessing the effect of Measurement-Based Care depression treatment on HIV medication adherence and health outcomes: rationale and design of the SLAM DUNC Study.

    Pence, Brian W; Gaynes, Bradley N; Williams, Quinn; Modi, Riddhi; Adams, Julie; Quinlivan, E Byrd; Heine, Amy; Thielman, Nathan; Mugavero, Michael J

    2012-07-01

    Depression affects 20-30% of people living with HIV/AIDS (PLWHA) in the U.S. and predicts greater sexual risk behaviors, lower antiretroviral (ARV) medication adherence, and worse clinical outcomes. Yet little experimental evidence addresses the critical clinical question of whether depression treatment improves ARV adherence and clinical outcomes in PLWHA with depression. The Strategies to Link Antidepressant and Antiretroviral Management at Duke, UAB, and UNC (SLAM DUNC) Study is a randomized clinical effectiveness trial funded by the National Institute for Mental Health. The objective of SLAM DUNC is to test whether a depression treatment program integrated into routine HIV clinical care affects ARV adherence. PLWHA with depression (n=390) are randomized to enhanced usual care or a depression treatment model called Measurement-Based Care (MBC). MBC deploys a clinically supervised Depression Care Manager (DCM) to provide evidence-based antidepressant treatment recommendations to a non-psychiatric prescribing provider, guided by systematic and ongoing measures of depressive symptoms and side effects. MBC has limited time requirements and the DCM role can be effectively filled by a range of personnel given appropriate training and supervision, enhancing replicability. In SLAM DUNC, MBC is integrated into HIV care to support HIV providers in antidepressant prescription and management. The primary endpoint is ARV adherence measured by unannounced telephone-based pill counts at 6 months with follow-up to 12 months and secondary endpoints including viral load, health care utilization, and depressive severity. Important outcomes of this study will be evidence of the effectiveness of MBC in treating depression in PLWHA and improving HIV-related outcomes. PMID:22542960

  10. Rationale and design of three observational, prospective cohort studies including biobanking to evaluate and improve diagnostics, management strategies and risk stratification in venous thromboembolism: the VTEval Project

    Frank, Bernd; Ariza, Liana; Lamparter, Heidrun; Grossmann, Vera; Prochaska, Jürgen H; Ullmann, Alexander; Kindler, Florentina; Weisser, Gerhard; Walter, Ulrich; Lackner, Karl J; Espinola-Klein, Christine; Münzel, Thomas; Konstantinides, Stavros V; Wild, Philipp S

    2015-01-01

    Introduction Venous thromboembolism (VTE) with its two manifestations deep vein thrombosis (DVT) and pulmonary embolism (PE) is a major public health problem. The VTEval Project aims to investigate numerous research questions on diagnosis, clinical management, treatment and prognosis of VTE, which have remained uncertain to date. Methods and analysis The VTEval Project consists of three observational, prospective cohort studies on VTE comprising cohorts of individuals with a clinical suspicion of acute PE (with or without DVT), with a clinical suspicion of acute DVT (without symptomatic PE) and with an incidental diagnosis of VTE (PE or DVT). The VTEval Project expects to enrol a total of approximately 2000 individuals with subsequent active and passive follow-up investigations over a time period of 5 years per participant. Time points for active follow-up investigations are at months 3, 6, 12, 24 and 36 after diagnosis (depending on the disease cohort); passive follow-up investigations via registry offices and the cancer registry are performed 48 and 60 months after diagnosis for all participants. Primary short-term outcome is defined by overall mortality (PE-related death and all other causes of death), primary long-term outcome by symptomatic VTE (PE-related death, recurrence of non-fatal PE or DVT). The VTEval Project includes three ‘all-comer’ studies and involves the standardised acquisition of high-quality data, covering the systematic assessment of VTE including symptoms, risk profile, psychosocial, environmental and lifestyle factors as well as clinical and subclinical disease, and it builds up a large state-of-the-art biorepository containing various materials from serial blood samplings. Ethics and dissemination The VTEval Project has been approved by the local data safety commissioner and the responsible ethics committee (reference no. 837.320.12 (8421-F)). Trial results will be published in peer-reviewed journals and presented at national and

  11. The Alberta population-based prospective evaluation of the quality of life outcomes and economic impact of bariatric surgery (APPLES study: background, design and rationale

    McCargar Linda

    2010-10-01

    Full Text Available Abstract Background Extreme obesity affects nearly 8% of Canadians, and is debilitating, costly and ultimately lethal. Bariatric surgery is currently the most effective treatment available; is associated with reductions in morbidity/mortality, improvements in quality of life; and appears cost-effective. However, current demand for surgery in Canada outstrips capacity by at least 1000-fold, causing exponential increases in already protracted, multi-year wait-times. The objectives and hypotheses of this study were as follows: 1. To serially assess the clinical, economic and humanistic outcomes in patients wait-listed for bariatric care over a 2-year period. We hypothesize deterioration in these outcomes over time; 2. To determine the clinical effectiveness and changes in quality of life associated with modern bariatric procedures compared with medically treated and wait-listed controls over 2 years. We hypothesize that surgery will markedly reduce weight, decrease the need for unplanned medical care, and increase quality of life; 3. To conduct a 3-year (1 year retrospective and 2 year prospective economic assessment of bariatric surgery compared to medical and wait-listed controls from the societal, public payor, and health-care payor perspectives. We hypothesize that lower indirect, out of pocket and productivity costs will offset increased direct health-care costs resulting in lower total costs for bariatric surgery. Methods/design Population-based prospective cohort study of 500 consecutive, consenting adults, including 150 surgically treated patients, 200 medically treated patients and 150 wait-listed patients. Subjects will be enrolled from the Edmonton Weight Wise Regional Obesity Program (Edmonton, Alberta, Canada, with prospective bi-annual follow-up for 2 years. Mixed methods data collection, linking primary data to provincial administrative databases will be employed. Major outcomes include generic, obesity-specific and preference

  12. Integrating a family-focused approach into child obesity prevention: Rationale and design for the My Parenting SOS study randomized control trial

    Campbell Marci

    2011-06-01

    Full Text Available Abstract Background More than 20% of US children ages 2-5 yrs are classified as overweight or obese. Parents greatly influence the behaviors their children adopt, including those which impact weight (e.g., diet and physical activity. Unfortunately, parents often fail to recognize the risk for excess weight gain in young children, and may not be motivated to modify behavior. Research is needed to explore intervention strategies that engage families with young children and motivate parents to adopt behaviors that will foster healthy weight development. Methods This study tests the efficacy of the 35-week My Parenting SOS intervention. The intervention consists of 12 sessions: initial sessions focus on general parenting skills (stress management, effective parenting styles, child behavior management, coparenting, and time management and later sessions apply these skills to promote healthier eating and physical activity habits. The primary outcome is change in child percent body fat. Secondary measures assess parent and child dietary intake (three 24-hr recalls and physical activity (accelerometry, general parenting style and practices, nutrition- and activity-related parenting practices, and parent motivation to adopt healthier practices. Discussion Testing of these new approaches contributes to our understanding of how general and weight-specific parenting practices influence child weight, and whether or not they can be changed to promote healthy weight trajectories. Trial Registration ClinicalTrials.gov: NCT00998348

  13. Menaquinone-7 Supplementation to Reduce Vascular Calcification in Patients with Coronary Artery Disease: Rationale and Study Protocol (VitaK-CAC Trial

    Liv M. Vossen

    2015-10-01

    Full Text Available Coronary artery calcification (CAC develops early in the pathogenesis of atherosclerosis and is a strong and independent predictor of cardiovascular disease (CVD. Arterial calcification is caused by an imbalance in calcification regulatory mechanisms. An important inhibitor of calcification is vitamin K-dependent matrix Gla protein (MGP. Both preclinical and clinical studies have shown that inhibition of the vitamin K-cycle by vitamin K antagonists (VKA results in elevated uncarboxylated MGP (ucMGP and subsequently in extensive arterial calcification. This led us to hypothesize that vitamin K supplementation may slow down the progression of calcification. To test this, we designed the VitaK-CAC trial which analyses effects of menaquinone-7 (MK-7 supplementation on progression of CAC. The trial is a double-blind, randomized, placebo-controlled trial including patients with coronary artery disease (CAD. Patients with a baseline Agatston CAC-score between 50 and 400 will be randomized to an intervention-group (360 microgram MK-7 or a placebo group. Treatment duration will be 24 months. The primary endpoint is the difference in CAC-score progression between both groups. Secondary endpoints include changes in arterial structure and function, and associations with biomarkers. We hypothesize that treatment with MK-7 will slow down or arrest the progression of CAC and that this trial may lead to a treatment option for vascular calcification and subsequent CVD.

  14. Do studies on cortical plasticity provide a rationale for using non invasive brain stimulation as a treatment for Parkinson’s disease patients?

    Giacomo eKoch

    2013-11-01

    Full Text Available Animal models of Parkinson’s disease (PD have shown that key mechanisms of cortical plasticity such as long-term potentiation (LTP and long-term depression (LTD can be impaired by the PD pathology. In humans protocols of non-invasive brain stimulation, such as paired associative stimulation (PAS and theta burst stimulation (TBS, can be used to investigate cortical plasticity of the primary motor cortex. Through the amplitude of the motor evoked potential (MEP these transcranial magnetic stimulation methods allow to measure both LTP-like and LTD-like mechanisms of cortical plasticity. So far these protocols have reported some controversial findings when tested in PD patients. While various studies described evidence for reduced LTP- and LTD-like plasticity, others showed different results, demonstrating increased LTP-like and normal LTD-like plasticity. Recent evidence provided support to the hypothesis that these different patterns of cortical plasticity likely depend on the stage of the disease and on the concomitant administration of levo-dopa. However, it still unclear how and if these altered mechanisms of cortical plasticity can be taken as a reliable model to build appropriate protocols aimed at treating PD symptoms b

  15. A Rationale for Pollutograph Evaluation in Ungauged Areas, Using Daily Rainfall Patterns: Case Studies of the Apulian Region in Southern Italy

    Angela Gorgoglione

    2016-01-01

    Full Text Available In the context of the implementation of sustainable water treatment technologies for soil pollution prevention, a methodology that try to overcome the lack of runoff quality data in Puglia (Southern Italy is firstly tackled in this paper. It provides a tool to obtain total suspended solid (TSS pollutographs in areas without availability of monitoring campaigns. The proposed procedure is based on the relationship between rainfall characteristics and pollutant wash-off. In particular, starting from the evaluation of the observed regional rainfall patterns by using a rainfall generator model, the storm water management model (SWMM was applied on five case studies located in different climatic subareas. The quantity SWMM parameters were evaluated starting from the drainage network and catchments characteristics, while the quality parameters were obtained from results of a monitoring campaign conducted for quality model calibration and validation with reference to the pollutograph’s shape and the peak-time. The research yields a procedure useful to evaluate the first flush phenomenon in ungauged sites and, in particular, it provides interesting information for designing efficient and sustainable drainage systems for first flush treatment and diffuse pollution treatment.

  16. Biventricular stimulation to prevent cardiac desynchronization: rationale, design, and endpoints of the 'Biventricular Pacing for Atrioventricular Block to Prevent Cardiac Desynchronization (BioPace)' study.

    Funck, Reinhard C; Blanc, Jean-Jacques; Mueller, Hans-Helge; Schade-Brittinger, Carmen; Bailleul, Christophe; Maisch, Bernhard

    2006-08-01

    Despite the deleterious effects of cardiac dyssynchrony and the positive effects of cardiac resynchronization therapy, patients with high-degree atrioventricular block continue to receive desynchronizing right ventricular (RV) pacing systems. Although it is unclear whether the negative effects of RV pacing and left bundle branch block (LBBB) are comparable, and whether they depend on the presence and the degree of structural heart disease, one may hypothesize that RV pacing may have similar effects to LBBB. In the BioPace trial, the long-term effects of RV pacing vs. biventricular pacing will be prospectively compared in 1200 pacemaker patients with high likelihood of mostly paced ventricular events, regardless of whether in sinus rhythm or in atrial fibrillation (AF). After echocardiographic examination of left ventricular (LV) function, patients will be randomly assigned to the implantation of an RV vs. a biventricular pacing system and followed for up to 5 years. Primary study endpoints are survival, quality of life (QoL), and the distance covered in a 6-min hall walk (6-MHW) at 24 months after implantation. Secondary endpoints are QoL and the 6-MHW result at 12 months after implantation, hospitalization rate, LV dimensions, LV ejection fraction, and the development of chronic AF and other adverse events. PMID:16864616

  17. Distance learning strategies for weight management utilizing social media: A comparison of phone conference call versus social media platform. Rationale and design for a randomized study.

    Willis, Erik A; Szabo-Reed, Amanda N; Ptomey, Lauren T; Steger, Felicia L; Honas, Jeffery J; Al-Hihi, Eyad M; Lee, Robert; Vansaghi, Lisa; Washburn, Richard A; Donnelly, Joseph E

    2016-03-01

    Management of obesity in the context of the primary care physician visit is of limited efficacy in part because of limited ability to engage participants in sustained behavior change between physician visits. Therefore, healthcare systems must find methods to address obesity that reach beyond the walls of clinics and hospitals and address the issues of lifestyle modification in a cost-conscious way. The dramatic increase in technology and online social networks may present healthcare providers with innovative ways to deliver weight management programs that could have an impact on health care at the population level. A randomized study will be conducted on 70 obese adults (BMI 30.0-45.0kg/m(2)) to determine if weight loss (6months) is equivalent between weight management interventions utilizing behavioral strategies by either a conference call or social media approach. The primary outcome, body weight, will be assessed at baseline and 6months. Secondary outcomes including waist circumference, energy and macronutrient intake, and physical activity will be assessed on the same schedule. In addition, a cost analysis and process evaluation will be completed. PMID:26883282

  18. Depression in Primary care: Interpersonal Counseling vs Selective serotonin reuptake inhibitors. The DEPICS Study. A multicenter randomized controlled trial. Rationale and design

    Scocco Paolo

    2010-11-01

    Full Text Available Abstract Background Depression is a frequently observed and disabling condition in primary care, mainly treated by Primary Care Physicians with antidepressant drugs. Psychological interventions are recommended as first-line treatment by the most authoritative international guidelines but few evidences are available on their efficacy and effectiveness for mild depression. Methods/Design This multi-center randomized controlled trial was conducted in 9 Italian centres with the aim to compare the efficacy of Inter-Personal Counseling, a brief structured psychological intervention, to that of Selective Serotonin Reuptake Inhibitors. Patients with depressive symptoms referred by Primary Care Physicians to psychiatric consultation-liaison services were eligible for the study if they met the DSM-IV criteria for major depression, had a score ≥13 on the 21-item Hamilton Depression Rating Scale, and were at their first or second depressive episode. The primary outcome was remission of depressive symptoms at 2-months, defined as a HDRS score ≤ 7. Secondary outcome measures were improvement in global functioning and recurrence of depressive symptoms at 12-months. Patients who did not respond to Inter-Personal Counseling or Selective Serotonin Reuptake Inhibitors at 2-months received augmentation with the other treatment. Discussion This trial addresses some of the shortcomings of existing trials targeting major depression in primary care by evaluating the comparative efficacy of a brief psychological intervention that could be easily disseminated, by including a sample of patients with mild/moderate depression and by using different outcome measures. Trial registration Australian New Zealand Clinical Trials Registry ACTRN12608000479303

  19. Study rationale and protocol: prospective randomized comparison of metal ion concentrations in the patient's plasma after implantation of coated and uncoated total knee prostheses

    Günther Klaus-Peter

    2009-10-01

    Full Text Available Abstract Background Any metal placed in a biological environment undergoes corrosion. Thus, with their large metallic surfaces, TKA implants are particularly prone to corrosion with subsequent release of metal ions into the human body which may cause local and systemic toxic effects and hypersensitivity reactions, and increase cancer risk. To address this problem, a new 7-layer zirconium coating developed especially for cobalt-chrome orthopaedic implants was tested biomechanically and found to lower metal ion release. The purpose of the proposed clinical trial is to compare the metal ion concentration in patients' plasma before and after implantation of a coated or uncoated TKA implant. Methods/Design In this randomised controlled trial, 120 patients undergoing primary TKA will be recruited at the Department of Orthopaedic Surgery of the University Hospital in Dresden, Germany, and randomised to either the coated or uncoated prosthesis. Outcome assessments will be conducted preoperatively and at 3 months, 12 months and 5 years postoperatively. The primary clinical endpoint will be the chromium ion concentration in the patient's plasma after 1 and 5 years. Secondary outcomes include cobalt, molybdenum and nickel ion concentrations after 1 and 5 years, allergy testing for hypersensitivity against one of these metals, the Knee Society Score to assess clinical and physical function of the knee joint, the self-assessment Oxford Score and the Short Form 36 quality of live questionnaire. Discussion The metal ion concentration in the patient's plasma has been shown to increase after TKA, its eventual adverse effects being widely debated. In the light of this discussion, ways to reduce metal ion release from orthopaedic implants should be studied in detail. The results of this investigation may lead to a new method to achieve this goal. Trials register Clinicaltrials registry NCT00862511

  20. Hand-suture versus stapling for closure of loop ileostomy: HASTA-Trial: a study rationale and design for a randomized controlled trial

    Krüger Matthias

    2011-02-01

    Full Text Available Abstract Background Colorectal cancer is the second most common tumor in developed countries, with a lifetime prevalence of 5%. About one third of these tumors are located in the rectum. Surgery in terms of low anterior resection with mesorectal excision is the central element in the treatment of rectal cancer being the only option for definite cure. Creating a protective diverting stoma prevents complications like anastomotic failure and meanwhile is the standard procedure. Bowel obstruction is one of the main and the clinically and economically most relevant complication following closure of loop ileostomy. The best surgical technique for closure of loop ileostomy has not been defined yet. Methods/Design A study protocol was developed on the basis of the only randomized controlled mono-center trial to solve clinical equipoise concerning the optimal surgical technique for closure of loop ileostomy after low anterior resection due to rectal cancer. The HASTA trial is a multi-center pragmatic randomized controlled surgical trial with two parallel groups to compare hand-suture versus stapling for closure of loop ileostomy. It will include 334 randomized patients undergoing closure of loop ileostomy after low anterior resection with protective ileostomy due to rectal cancer in approximately 20 centers consisting of German hospitals of all level of health care. The primary endpoint is the rate of bowel obstruction within 30 days after ileostomy closure. In addition, a set of surgical and general variables including quality of life will be analyzed with a follow-up of 12 months. An investigators meeting with a practical session will help to minimize performance bias and enforce protocol adherence. Centers are monitored centrally as well as on-site before and during recruitment phase to assure inclusion, treatment and follow up according to the protocol. Discussion Aim of the HASTA trial is to evaluate the efficacy of hand-suture versus stapling for

  1. Referral from primary care to a physical activity programme: establishing long-term adherence? A randomized controlled trial. Rationale and study design

    Puig-Ribera Anna

    2009-01-01

    . Discussion The pilot study showed the effectiveness of an enhanced low-cost, evidence-based intervention in increased physical activity and improved social support. If successful in demonstrating long-term improvements, this randomised controlled trial will be the first sustainable physical activity intervention based in primary care in our country to demonstrate long-term adherence to physical activity. Trial Registration A service of the U.S. National Institutes of Health. Developed by the National Library of Medicine. ClinicalTrials.gov ID: NCT00714831.

  2. The Effects of Rationales, Differential Reinforcement, and a Guided Compliance Procedure to Increase Compliance among Preschool Children

    Wilder, David A.; Myers, Kristin; Nicholson, Katie; Allison, Janelle; Fischetti, Anthony T.

    2012-01-01

    Previous research suggests that rationales, or statements describing why a child should comply with a caregiver-delivered instruction, are ineffective at increasing compliance. In the current study, we compared the effects of rationales to a differential reinforcement procedure and a guided compliance procedure. The results indicated that…

  3. CYP2C19 genotype-guided antiplatelet therapy in ST-segment elevation myocardial infarction patients-Rationale and design of the Patient Outcome after primary PCI (POPular) Genetics study

    Bergmeijer, Thomas O.; Janssen, Paul W.A.; Schipper, Jurjan C.; Qaderdan, Khalid; Ishak, Maycel; Ruitenbeek, Rianne S.; Asselbergs, Folkert W.; van 't Hof, Arnoud W.J.; Dewilde, Willem J.M.; Spanó, Fabrizio; Herrman, Jean-Paul R.; Kelder, Johannes C.; Postma, Maarten J.; de Boer, Anthonius; Deneer, Vera H.M.; ten Berg, Jurriën M.

    2014-01-01

    RATIONALE: In patients with ST-segment elevation myocardial infarction (STEMI) who undergo primary percutaneous coronary intervention (pPCI), the use of dual antiplatelet therapy is essential to prevent atherothrombotic complications. Therefore, patients are treated with acetylsalicylic acid and clo

  4. Ticagrelor or prasugrel versus clopidogrel in elderly patients with an acute coronary syndrome: Optimization of antiplatelet treatment in patients 70years and older-rationale and design of the POPular AGE study

    Qaderdan, K.; Ishak, M.; Heestermans, A.A.; Vrey, E. de; Jukema, J.W.; Voskuil, M.; Boer, M.J. de; Hof, A.W.J.; Groenemeijer, B.E.; Vos, G.J.; Janssen, P.W.; Bergmeijer, T.O.; Kelder, J.C.; Deneer, V.H.; Berg, J.M. van den

    2015-01-01

    RATIONALE: Dual antiplatelet therapy with acetylsalicylic acid in combination with a more potent P2Y12- inhibitor (ticagrelor or prasugrel) is recommended in patients with acute coronary syndrome without ST-segment elevation (NSTE-ACS) to prevent atherothrombotic complications. The evidence on which

  5. Ticagrelor or prasugrel versus clopidogrel in elderly patients with an acute coronary syndrome : Optimization of antiplatelet treatment in patients 70years and older-rationale and design of the POPular AGE study

    Qaderdan, Khalid; Ishak, Maycel; Heestermans, Antonius A C M; de Vrey, Evelyn; Jukema, J Wouter; Voskuil, Michiel; de Boer, Menko-Jan; Van't Hof, Arnoud W J; Groenemeijer, Björn E; Vos, Gerrit-Jan A; Janssen, Paul W A; Bergmeijer, Thomas O; Kelder, Johannes C; Deneer, Vera H M; Ten Berg, Jurriën M

    2015-01-01

    RATIONALE: Dual antiplatelet therapy with acetylsalicylic acid in combination with a more potent P2Y12- inhibitor (ticagrelor or prasugrel) is recommended in patients with acute coronary syndrome without ST-segment elevation (NSTE-ACS) to prevent atherothrombotic complications. The evidence on which

  6. Combination therapy with dutasteride and tamsulosin in men with moderate-to-severe benign prostatic hyperplasia and prostate enlargement: the CombAT (Combination of Avodart and Tamsulosin) trial rationale and study design.

    Siami, Paul; Roehrborn, Claus G; Barkin, Jack; Damiao, Ronaldo; Wyczolkowski, Marek; Duggan, Annette; Major-Walker, Kim; Morrill, Betsy B

    2007-11-01

    Benign prostatic hyperplasia (BPH) is a highly prevalent condition in aging men, which can be progressive and lead to acute urinary retention (AUR) and the need for surgery. It is commonly treated with alpha-blockers and 5alpha-reductase inhibitors (5ARIs), both of which improve the symptoms of BPH. Long-term treatment with 5ARIs can also reduce the risk of developing AUR and the need for surgery. The landmark Medical Therapy of Prostatic Symptoms (MTOPS) trial demonstrated that over 4 years the combination of the type 2-specific 5ARI, finasteride and the alpha-blocker doxazosin was more effective than either agent alone in reducing overall clinical progression. Since the initiation of MTOPS, it has been shown that patients with larger prostates and higher prostate-specific antigen (PSA) levels are at greater risk of BPH progression, and are therefore arguably more likely to benefit from combination therapy. The Combination of Avodart and Tamsulosin (CombAT) trial is a 4-year, global, multicenter, randomized, double-blind, parallel-group study designed to investigate the benefits of combination therapy with the dual 5ARI dutasteride and the alpha-blocker tamsulosin compared with each monotherapy in improving symptoms and long-term outcomes in men with moderate-to-severe symptoms of BPH and prostate enlargement. Symptoms and long-term outcomes (AUR and surgery) will be assessed as separate primary endpoints at 2 and 4 years, respectively. Eligible patients were at least 50 years old with prostate volume > or =30 cm(3) and PSA level > or =1.5 ng/mL. A total of 4838 subjects have been enrolled. This paper describes the rationale, design and baseline data of the CombAT study. PMID:17761460

  7. Rationale and design of ARTS

    Pitt, Bertram; Filippatos, Gerasimos; Gheorghiade, Mihai; Kober, Lars; Krum, Henry; Ponikowski, Piotr; Nowack, Christina; Kolkhof, Peter; Kim, So-Young; Zannad, Faiez

    2012-01-01

    AIMS: BAY 94-8862 is a novel, non-steroidal, mineralocorticoid receptor antagonist with greater selectivity than spironolactone and stronger mineralocorticoid receptor binding affinity than eplerenone. The aims of the MinerAlocorticoid Receptor Antagonist Tolerability Study (ARTS; NCT01345656) ar...... expected to provide a wealth of information on BAY 94-8862 in patients with HFREF and CKD, including the optimal dose range for further studies....

  8. Study design and rationale for investigating phosphodiesterase type 5 inhibition for the treatment of pulmonary hypertension due to chronic obstructive lung disease: the TADA-PHiLD (TADAlafil for Pulmonary Hypertension associated with chronic obstructive Lung Disease) trial.

    Maron, Bradley A; Goldstein, Ronald H; Rounds, Sharon I; Shapiro, Shelley; Jankowich, Matthew; Garshick, Eric; Moy, Marilyn L; Gagnon, David; Choudhary, Gaurav

    2013-12-01

    In patients with chronic obstructive pulmonary disease (COPD), moderate or severe pulmonary hypertension (COPD-PH) is associated with increased rates of morbidity and mortality. Despite this, approaches to treatment and the efficacy of phosphodiesterase type 5 inhibition (PDE-5i) in COPD-PH are unresolved. We present the clinical rationale and study design to assess the effect of oral tadalafil on exercise capacity, cardiopulmonary hemodynamics, and clinical outcome measures in COPD-PH patients. Male and female patients 40-85 years old with GOLD stage 2 COPD or higher and pulmonary hypertension diagnosed on the basis of invasive cardiac hemodynamic assessment (mean pulmonary artery pressure [mPAP] >30 mmHg, pulmonary vascular resistance [PVR] >2.5 Wood units, and pulmonary capillary wedge pressure ≤18 mmHg at rest) will be randomized at a 1∶1 ratio to receive placebo or oral PDE-5i with tadalafil (40 mg daily for 12 months). The primary end point is change from baseline in 6-minute walk distance at 12 months. The secondary end points are change from baseline in PVR and mPAP at 6 months and change from baseline in peak volume of oxygen consumption ([Formula: see text]) during exercise at 12 months. Changes in systemic blood pressure and/or oxyhemoglobin saturation (Sao2) at rest and during exercise will function as safety outcome measures. TADA-PHiLD (TADAlafil for Pulmonary Hypertension assocIated with chronic obstructive Lung Disease) is the first sufficiently powered randomized clinical trial testing the effect of PDE-5i on key clinical and drug safety outcome measures in patients with at least moderate PH due to COPD. PMID:25006405

  9. Rationale and design of XAMOS

    Turpie, Alexander G G; Schmidt, André C; Kreutz, Reinhold; Rud-Lassen, Michael; Jamal, Waheed; Mantovani, Lorenzo; Haas, Sylvia

    2012-01-01

    Venous thromboembolism is a frequent and potentially life-threatening complication of orthopedic surgery. Rivaroxaban is an oral direct factor Xa inhibitor, which was shown to be effective for the prevention of venous thromboembolism after elective hip and knee arthroplasty in the RECORD study...... program. Rivaroxaban has the potential to overcome the limitations of the current standards of care in the prevention of venous thromboembolism. XAMOS (Xarelto(®) in the prophylaxis of post-surgical venous thromboembolism after elective major orthopedic surgery of hip or knee) is an international......, noninterventional, parallel-group study to gain insight into the safety (major bleeding, side effects) and effectiveness (prevention of symptomatic thromboembolic events) of rivaroxaban in daily clinical practice. XAMOS will follow 15,000 patients after major orthopedic surgery in approximately 200 centers...

  10. Getting inside acupuncture trials - Exploring intervention theory and rationale

    Godfrey Mary

    2011-03-01

    Full Text Available Abstract Background Acupuncture can be described as a complex intervention. In reports of clinical trials the mechanism of acupuncture (that is, the process by which change is effected is often left unstated or not known. This is problematic in assisting understanding of how acupuncture might work and in drawing together evidence on the potential benefits of acupuncture. Our aim was to aid the identification of the assumed mechanisms underlying the acupuncture interventions in clinical trials by developing an analytical framework to differentiate two contrasting approaches to acupuncture (traditional acupuncture and Western medical acupuncture. Methods Based on the principles of realist review, an analytical framework to differentiate these two contrasting approaches was developed. In order to see how useful the framework was in uncovering the theoretical rationale, it was applied to a set of trials of acupuncture for fatigue and vasomotor symptoms, identified from a wider literature review of acupuncture and early stage breast cancer. Results When examined for the degree to which a study demonstrated adherence to a theoretical model, two of the fourteen selected studies could be considered TA, five MA, with the remaining seven not fitting into any recognisable model. When examined by symptom, five of the nine vasomotor studies, all from one group of researchers, are arguably in the MA category, and two a TA model; in contrast, none of the five fatigue studies could be classed as either MA or TA and all studies had a weak rationale for the chosen treatment for fatigue. Conclusion Our application of the framework to the selected studies suggests that it is a useful tool to help uncover the therapeutic rationale of acupuncture interventions in clinical trials, for distinguishing between TA and MA approaches and for exploring issues of model validity. English language acupuncture trials frequently fail to report enough detail relating to the

  11. Design and rationale of FOCUS (PX-171-011: A randomized, open-label, phase 3 study of carfilzomib versus best supportive care regimen in patients with relapsed and refractory multiple myeloma (R/R MM

    Hájek Roman

    2012-09-01

    Full Text Available Abstract Background Carfilzomib is a next-generation proteasome inhibitor with single-agent activity in patients with relapsed and refractory multiple myeloma (R/R MM. In PX-171-003-A1, a single-arm phase 2 study of carfilzomib monotherapy in heavily pretreated patients, the overall response rate was 23.7%, 37% of patients achieved ≥ minimal response and median overall survival (OS was 15.6 months. Based on this study, carfilzomib was recently approved by the US Food and Drug Administration for the treatment of R/R MM. Herein we describe the trial design and rationale for a phase 3 randomized study, FOCUS (CarFilzOmib for AdvanCed Refractory MUltiple Myeloma European Study, being conducted to compare OS after treatment with single-agent carfilzomib to best supportive care (BSC regimen in R/R MM. Methods Patients must have received ≥3 prior regimens, must be responsive to at least 1 line of therapy, and be refractory to their most recent therapy. Eligible patients are randomized 1:1 to receive either carfilzomib (28-day cycles at 20 mg/m2 IV on Days 1–2 of Cycle 1, escalating to 27 mg/m2 IV on Days 8, 9, 15, and 16 and continuing at 27 mg/m2 through Cycle 9 and Days 1, 2, 15, and 16 ≥ Cycle 10 or an active BSC regimen (corticosteroid treatment of prednisolone 30 mg, dexamethasone 6 mg, or equivalent every other day with optional cyclophosphamide 50 mg PO once daily. Patients will continue treatment until disease progression, unacceptable toxicity, or treatment discontinuation and will then enter long-term follow-up for survival. The primary endpoint is OS and secondary endpoints include progression-free survival, overall response rate, and safety. Disease assessments will be determined according to the International Myeloma Working Group Uniform Response Criteria with minimal response per European Blood and Marrow Transplantation Group criteria. Conclusions This phase 3 trial will provide more rigorous data for carfilzomib, as

  12. Design and rationale of FOCUS (PX-171-011): A randomized, open-label, phase 3 study of carfilzomib versus best supportive care regimen in patients with relapsed and refractory multiple myeloma (R/R MM)

    Carfilzomib is a next-generation proteasome inhibitor with single-agent activity in patients with relapsed and refractory multiple myeloma (R/R MM). In PX-171-003-A1, a single-arm phase 2 study of carfilzomib monotherapy in heavily pretreated patients, the overall response rate was 23.7%, 37% of patients achieved ≥ minimal response and median overall survival (OS) was 15.6 months. Based on this study, carfilzomib was recently approved by the US Food and Drug Administration for the treatment of R/R MM. Herein we describe the trial design and rationale for a phase 3 randomized study, FOCUS (CarFilzOmib for AdvanCed Refractory MUltiple Myeloma European Study), being conducted to compare OS after treatment with single-agent carfilzomib to best supportive care (BSC) regimen in R/R MM. Patients must have received ≥3 prior regimens, must be responsive to at least 1 line of therapy, and be refractory to their most recent therapy. Eligible patients are randomized 1:1 to receive either carfilzomib (28-day cycles at 20 mg/m2 IV on Days 1–2 of Cycle 1, escalating to 27 mg/m2 IV on Days 8, 9, 15, and 16 and continuing at 27 mg/m2 through Cycle 9 and Days 1, 2, 15, and 16 ≥ Cycle 10) or an active BSC regimen (corticosteroid treatment of prednisolone 30 mg, dexamethasone 6 mg, or equivalent every other day with optional cyclophosphamide 50 mg PO once daily). Patients will continue treatment until disease progression, unacceptable toxicity, or treatment discontinuation and will then enter long-term follow-up for survival. The primary endpoint is OS and secondary endpoints include progression-free survival, overall response rate, and safety. Disease assessments will be determined according to the International Myeloma Working Group Uniform Response Criteria with minimal response per European Blood and Marrow Transplantation Group criteria. This phase 3 trial will provide more rigorous data for carfilzomib, as this is the first carfilzomib study with OS as the primary

  13. Risk analysis and safety rationale

    Decision making with respect to safety is becoming more and more complex. The risk involved must be taken into account together with numerous other factors such as the benefits, the uncertainties and the public perception. Can the decision maker be aided by some kind of system, general rules of thumb, or broader perspective on similar decisions? This question has been addressed in a joint Nordic project relating to nuclear power. Modern techniques for risk assessment and management have been studied, and parallels drawn to such areas as offshore safety and management of toxic chemicals in the environment. The report summarises the finding of 5 major technical reports which have been published in the NORD-series. The topics includes developments, uncertainties and limitations in probabilistic safety assessments, negligible risks, risk-cost trade-offs, optimisation of nuclear safety and radiation protection, and the role of risks in the decision making process. (author) 84 refs

  14. Rationale and study design of a cross sectional study documenting the prevalence of Heart Failure amongst the minority ethnic communities in the UK: the E-ECHOES Study (Ethnic - Echocardiographic Heart of England Screening Study)

    Freemantle Nick; Davies Michael; Davis Russell; Gill Paramjit S; Lip Gregory YH

    2009-01-01

    Abstract Background Heart failure is an important cause of cardiovascular morbidity and mortality. Studies to date have not established the prevalence heart failure amongst the minority ethnic community in the UK. T'he aim of the E-ECHOES (Ethnic - Echocardiographic Heart of England Screening Study)is to establish, for the first time, the community prevalence and severity of left ventricular systolic dysfunction (LVSD) and heart failure amongst the South Asian and Black African-Caribbean ethn...

  15. Rationale and study design of a cross sectional study documenting the prevalence of Heart Failure amongst the minority ethnic communities in the UK: the E-ECHOES Study (Ethnic - Echocardiographic Heart of England Screening Study

    Freemantle Nick

    2009-09-01

    Full Text Available Abstract Background Heart failure is an important cause of cardiovascular morbidity and mortality. Studies to date have not established the prevalence heart failure amongst the minority ethnic community in the UK. T'he aim of the E-ECHOES (Ethnic - Echocardiographic Heart of England Screening Studyis to establish, for the first time, the community prevalence and severity of left ventricular systolic dysfunction (LVSD and heart failure amongst the South Asian and Black African-Caribbean ethnic groups in the UK. Methods/Design This is a community based cross-sectional population survey of a sample of South Asian (i.e. those originating from India, Pakistan, Bangladesh and Black African-Caribbean male and female subjects aged 45 years and over. Data collection undertaken using a standardised protocol comprising a questionnaire incorporating targeted clinical history taking, physical examination, and investigations with resting electrocardiography and echocardiography; and blood sampling with consent. This is the largest study on heart failure amongst these ethnic groups. Full data collection started in September 2006 and will be completed by August 2009. Discussion The E-ECHOES study will enable the planning and delivery of clinically and cost-effective treatment of this common and debilitating condition within these communities. In addition it will increase knowledge of the aetiology and management of heart failure within minority ethnic communities.

  16. Pilot Aircraft Interface Objectives/Rationale

    Shively, Jay

    2010-01-01

    Objective: Database and proof of concept for guidelines for GCS compliance a) Rationale: 1) Provide research test-bed to develop guidelines. 2) Modify GCS for NAS Compliance to provide proof of concept. b) Approach: 1) Assess current state of GCS technology. 2) Information Requirements Definition. 3) SME Workshop. 4) Modify an Existing GCS for NAS Compliance. 5) Define exemplar UAS (choose system to develop prototype). 6) Define Candidate Displays & Controls. 7) Evaluate/ refine in Simulations. 8) Demonstrate in flight. c) Deliverables: 1) Information Requirements Report. 2) Workshop Proceedings. 3) Technical Reports/ papers on Simulations & Flight Demo. 4) Database for guidelines.

  17. Rationale for reduced tornado design bases

    This paper provides a rationale for relaxing the present NRC tornado design requirements, which are based on a design basis tornado (DBT) whose frequency of exceedance is 10-7 per year. It is proposed that a reduced DBT frequency of 10-5 to 10-6 per year is acceptable. This change in the tornado design bases for LMFBRs (and possibly all types of nuclear plants) is justified based on (1) existing NRC regulations and guidelines, (2) probabilistic arguments, (3) consistency with NRC trial safety goals, and (4) cost-benefit analysis

  18. Rationales of Verse: Poe and Other Critics

    Barragão, Fernando Pedro Cleto Rodrigues

    2010-01-01

    “The Rationale of Verse” is probably among the less widely known theoretic/critical essays by Edgar Allan Poe. Nevertheless, it is a text whose rediscovery matters due to the pertinence of most of Poe’s conceptions regarding topics such as prosody and the correct scansion of a poem (if there is such a thing). Poe’s essay is also surprising because of the author’s proposal of a new method for scanning verse based on a musical notation. In this context, other authors such as Gerard Manley Hopki...

  19. Description and Rationale for the Planning, Monitoring, and Implementation (PMI) Model: Rationale.

    Cort, H. Russell

    The rationale for the Planning, Monitoring, and Implementation Model (PMI) is the subject of this paper. The Superintendent of the District of Columbia Public Schools requested a model for systematic evaluation of educational programs to determine their effectiveness. The school system's emphasis on objective-referenced instruction and testing,…

  20. Population Study of Urban, Rural, and Semiurban Regions for the Detection of Endovascular Disease and Prevalence of Risk Factors and Holistic Intervention Study: Rationale, Study Design, and Baseline Characteristics of PURSE-HIS.

    Thanikachalam, Sadagopan; Harivanzan, Vijayakumar; Mahadevan, Murugappapillai V; Murthy, J S N; Anbarasi, Chandrasekar; Saravanababu, Chidambaram S; Must, Aviva; Baliga, Ragavendra R; Abraham, William T; Thanikachalam, Mohan

    2015-12-01

    We designed and implemented the PURSE-HIS (Population Study of Urban, Rural and Semiurban Regions for the Detection of Endovascular Disease and Prevalence of Risk Factors and Holistic Intervention Study) to understand the prevalence and progression of subclinical and overt endovascular disease (EVD) and its risk factors in urban, semiurban, and rural communities in South India. The study is also designed to generate clinical evidence for effective, affordable, and sustainable community-specific intervention strategies to control risks factors for EVD. As of June 2012, 8,080 (urban: 2,221; semiurban: 2,821; rural: 3,038) participants >20 years of age were recruited using 2-stage cluster sampling. Baseline measurements included standard cardiovascular disease risk factors, sociodemographic factors, lifestyle habits, psychosocial factors, and nutritional assessment. Fasting blood samples were assayed for putative biochemical risk factors and urine samples for microalbuminuria. All nondiabetic participants underwent oral glucose tolerance test with blood and urine samples collected every 30 min for 2 h. Additional baseline measurements included flow-mediated brachial artery endothelial vasodilation, assessment of carotid intimal medial wall thickness using ultrasonography, screening for peripheral vascular disease using ankle and brachial blood pressures, hemodynamic screening using a high-fidelity applanation tonometry to measure central blood pressure parameters, and aortic pulse wave velocity. To assess prevalence of coronary artery disease, all participants underwent surface electrocardiography and documentation of ventricular wall motion abnormality and function using echocardiography imaging. To detect subclinical lesions, all eligible participants completed an exercise treadmill test. Prospectively, the study will assess progression of subclinical and overt EVD, including risk factor-outcome relation differences across communities. The study will also evaluate

  1. A dynamic-efficiency rationale for public investment in the health of young

    Andersen, Torben M.; Bhattacharya, Joydeep

    2014-01-01

    In this paper we assume away standard distributional and static-efficiency arguments for public health and instead seek a dynamic efficiency rationale. We study a lifecycle model wherein young agents make health investments to reduce mortality risk. We identify a welfare rationale for public health...... under dynamic efficiency and exogenous mortality even when private and public investments are perfect substitutes. If health investment reduces mortality risk but individuals do not internalize its effect on the life-annuity interest rate, the “Philipson-Becker effect” emerges; when the young are net...... borrowers, this works together with dynamic efficiency to support a role for public health....

  2. Rationale and design of a prospective study of the efficacy of a remote monitoring system used in implantable cardioverter defibrillator follow-up: the Lumos-T Reduces Routine Office Device Follow-Up Study (TRUST) study.

    Varma, Niraj

    2007-12-01

    Increased implantable cardioverter defibrillator (ICD) implant volumes (and product advisories/recalls) pose management challenges. Most device interrogations at 3- to 6-month routine follow-up visits are "nonactionable," that is, require no clinically significant reprogramming, lead revision, or initiation or up-titration of antiarrhythmic medications. Conversely, implanted devices collect important diagnostic data (eg, atrial fibrillation onset, system integrity) that remain concealed between device interrogations. Remote monitoring may resolve some of these challenges, but has not been studied in a large-scale clinical trial. Home Monitoring (HM) uses automatic (without patient intervention) data and electrogram transmissions with rapid (automatically occur between periodic checks for compromised system integrity (battery, lead parameters, high-voltage circuitry) or arrhythmia occurrence (eg, atrial fibrillation, ventricular arrhythmia). All study patients will have a final office visit 15 months after implant. The results of TRUST may confirm the role of remote monitoring as an intensive surveillance mechanism for device management. PMID:18035071

  3. Study of vitamin D status of rheumatoid arthritis patients Rationale and design of a cross-sectional study by the osteoporosis and metabolic bone diseases study group of the Italian Society of Rheumatology (SIR

    M. Antonelli

    2011-09-01

    Full Text Available The fundamental role of Vitamin D has been long known in regulating calcium homeostasis and bone metabolism. An increased contribution of Vitamin D was recently described in association with a lower incidence of Rheumatoid Arthritis (RA. This must not be surprising, as the immunomodulating effects of Vitamin D are clear, which have been attributed protective effects in autoimmune disorders such as some chronic inflammatory bowel diseases, multiple sclerosis and type I diabetes. An interaction was suggested between Vitamin D metabolism and inflammation indexes through mediation of TNF-a which is also especially involved in osteoclastic resorption and therefore in bone loss processes. Some preliminary data would indicate an association between seasonal changes of Vitamin D serum levels, latitude and disease activity (DAS28 in RA patients. Consequently, the Osteoporosis and Metabolic Bone Diseases Study Group of SIR believes that there are grounded reasons for assessing the Vitamin D status of RA patients in order to investigate whether this is to be related to physiopathological and clinical aspects of disease other than those of bone involvement. Primary end point of the study will be to assess the levels of 25 OH Vitamin D in RA patients. Secondary endpoints will include correlation with disease activity, densitometry values and bone turnover. The cross-sectional study will enrol patients of both sex genders, age ranging between 30 and 75 years according to the 1988 ACR criteria, onset of symptoms at least 2 years prior to study enrollment. Patients will be excluded suffering from osteometabolic diseases, liver and kidney insufficiency and those administered Vitamin D boli in the previous 12 months. Disease activity will be evaluated with the HAQ. Haematochemical tests and femoral and lumbar bone densitometry will be performed, unless recently undergone by patients. Blood levels of 25 OH C Vitamin D and PHT and of the two bone remodeling markers

  4. "Socialized Music": Historical Formations of Community Music through Social Rationales

    Yerichuk, Deanna

    2014-01-01

    This article traces the formation of community music through professional and scholarly articles over the last century in North America, and argues that community music has been discursively formed through social rationales, although the specific rationales have shifted. The author employs an archaeological framework inspired by Michel Foucault to…

  5. Development of regulatory technical rationale for risk monitoring program

    Chung, Chang Hyun; Kim, Ju Youl; Kim, Yoon Ik; Yang, Hui Chang; Lee, Yong Suk; Ahn, Kwang Won; Kim, Se Hyung [Seoul National Univ., Seoul (Korea, Republic of)

    2002-03-15

    In Korea, the risk monitoring program will be developed and applied to each plants till 2003 by the severe accident management plan to enhance the safety functions of the nuclear power plants. Through this plan, the risk monitoring for the full power and low power and shutdown operation will be performed. Therefore the development of consistent risk monitoring system and overall regulatory guides for the risk monitoring program are necessary. The objective of this study is the development of regulatory technical rationales for the nuclear power plant risk monitoring program and the derivation of the requirements need for the development of risk monitoring system. Through this the improvement of regulatory effectiveness to assure the safe operation of nuclear power plant, is expected.

  6. The rationale for deep brain stimulation in Alzheimer's disease.

    Mirzadeh, Zaman; Bari, Ausaf; Lozano, Andres M

    2016-07-01

    Alzheimer's disease is a major worldwide health problem with no effective therapy. Deep brain stimulation (DBS) has emerged as a useful therapy for certain movement disorders and is increasingly being investigated for treatment of other neural circuit disorders. Here we review the rationale for investigating DBS as a therapy for Alzheimer's disease. Phase I clinical trials of DBS targeting memory circuits in Alzheimer's disease patients have shown promising results in clinical assessments of cognitive function, neurophysiological tests of cortical glucose metabolism, and neuroanatomical volumetric measurements showing reduced rates of atrophy. These findings have been supported by animal studies, where electrical stimulation of multiple nodes within the memory circuit have shown neuroplasticity through stimulation-enhanced hippocampal neurogenesis and improved performance in memory tasks. The precise mechanisms by which DBS may enhance memory and cognitive functions in Alzheimer's disease patients and the degree of its clinical efficacy continue to be examined in ongoing clinical trials. PMID:26443701

  7. Rationale awareness for quality assurance in iterative human computation processes

    Xiao, Lu

    2012-01-01

    Human computation refers to the outsourcing of computation tasks to human workers. It offers a new direction for solving a variety of problems and calls for innovative ways of managing human computation processes. The majority of human computation tasks take a parallel approach, whereas the potential of an iterative approach, i.e., having workers iteratively build on each other's work, has not been sufficiently explored. This study investigates whether and how human workers' awareness of previous workers' rationales affects the performance of the iterative approach in a brainstorming task and a rating task. Rather than viewing this work as a conclusive piece, the author believes that this research endeavor is just the beginning of a new research focus that examines and supports meta-cognitive processes in crowdsourcing activities.

  8. Vincristine in childhood leukaemia : no pharmacokinetic rationale for dose reduction in adolescents

    Frost, BM; Lonnerholm, G; Koopmans, P; Abrahamsson, J; Behrendtz, M; Castor, A; Forestier, E; Uges, DRA

    2003-01-01

    Aim: To investigate whether there is any pharmacokinetic rationale for the common practice of administering vincristine to adolescents at relatively lower doses than those to younger children. Methods: A total of 98 children, aged 1.3-17.3 y, with acute lymphoblastic leukaemia (ALL) were studied on

  9. Netherlands research programme weight gain prevention (NHF-NRG): rationale, objectives and strategies

    Kremers, S.P.; Schouten, E.G.; Kok, F.J.; Visscher, T.L.S.; Brug, J.; Kromhout, D.

    2005-01-01

    OBJECTIVE: To outline the rationale, objectives and strategies used in a systematically designed research programmme to study specific weight gain-inducing behaviours, their social-psychological as well as environmental determinants, and the effects of interventions aimed at the prevention of weight

  10. Rationale for Students' Participation in University Governance and Organizational Effectiveness in Ekiti and Ondo States, Nigeria

    Akomolafe, C. O.; Ibijola, E. Y.

    2012-01-01

    The study investigated the rationale for students' participation in university governance and organizational effectiveness. A descriptive research of survey design was adopted. The population consisted of all staff and students of Ekiti State University, Ado Ekiti, Ekiti State and Adekunle Ajasin University, Akungba-Akoko, Ondo State. 700 subjects…

  11. Opening Minds in Canada: Background and Rationale

    Stuart, Heather; Chen, Shu-Ping; Christie, Romie; Dobson, Keith; Kirsh, Bonnie; Knaak, Stephanie; Koller, Michelle; Krupa, Terry; Lauria-Horner, Bianca; Luong, Dorothy; Modgill, Geeta; Patten, Scott B; Pietrus, Mike; Szeto, Andrew; Whitley, Rob

    2014-01-01

    Objective: To summarize the background and rationale of the approach taken by the Mental Health Commission of Canada’s Opening Minds (OM) Anti-Stigma Initiative. Method: The approach taken by OM incorporates a grassroots, community development philosophy, has clearly defined target groups, uses contact-based education as the central organizing element across interventions, and has a strong evaluative component, so that best practices can be identified, replicated, and disseminated. Contact-based education occurs when people who have experienced a mental illness share their personal story of recovery and hope. Results: OM has acted as a catalyst to develop partnerships between community groups who are undertaking anti-stigma work and an interdisciplinary team of academic researchers in 5 universities who are evaluating the results of these programs. Conclusions: Building partnerships with existing community programs and promoting systematic evaluation using standardized approaches and instruments have contributed to our understanding of best practices in the field of anti-stigma programming. PMID:25565705

  12. Rationale for Antioxidant Supplementation in Hemodialysis Patients

    Morena Marion

    2001-01-01

    Full Text Available Oxidative stress, which results from an imbalance between reactive oxygen species (ROS production and antioxidant defense mechanisms, is now a well recognized pathogenic process in hemodialysis (HD patients that could be involved in dialysis-related pathologies such as accelerated atherosclerosis, amyloidosis and anemia. This review is aimed at evaluating the rationale for preventive intervention against oxidative damage during HD as well as the putative causal factors implicated in this imbalance. The antioxidant system is severely impaired in uremic patients and impairment increases with the degree of renal failure. HD further worsens this condition mainly by losses of hydrophilic unbound small molecular weight substances such as vitamin C, trace elements and enzyme regulatory compounds. Moreover, inflammatory state due to the hemo-incompatibility of the dialysis system plays a critical role in the production of oxidants contributing further to aggravate the pro-oxidant status of uremic patients. Prevention of ROS overproduction can be achieved by improvement of dialysis biocompatibility, a main component of adequate dialysis, and further complimented by antioxidant supplementation. This could be achieved either orally or via the extracorporeal circuit. Antioxidants such as vitamin E could be bound on dialyzer membranes. Alternatively, hemolipodialysis consisting of loading HD patients with vitamin C or E via an ancillary circuit made of vitamin E-rich liposomes may be used.

  13. Rationales for Place-based Approaches in Scotland

    Bynner, Claire

    2016-01-01

    The aim of this paper is to remove the confusion surrounding what place-based approaches are, the rationales behind their use, the development of this approach to public service reform in Scotland and the future challenges presented by austerity and welfare reform. Key arguments presented in this paper:  The rationales driving the emergence of new place-based approaches at the neighbourhood level include: o The Civic – in the need for higher quality, more responsive services and for co...

  14. Influencing Acceptability of Parent Training Interventions Through Treatment Rationales

    Chase, Trisha

    2015-01-01

    Parent training is an effective intervention for parents of children with a variety of childhood disorders, and parents often view behavioral parent training as acceptable. Explanations and rationales for parent training are commonly provided at the beginning of treatment. However, there is little research regarding how rationales may influence acceptability. There is also limited information on whether fathers and mothers judge the acceptability of parent training differently. The purpose of...

  15. Study design and rationale of "Synergistic Effect of Combination Therapy with Cilostazol and ProbUcol on Plaque Stabilization and Lesion REgression (SECURE" study: a double-blind randomised controlled multicenter clinical trial

    Lee Myoungsook

    2011-01-01

    Full Text Available Abstract Background Probucol, a cholesterol-lowering agent that paradoxically also lowers high-density lipoprotein cholesterol has been shown to prevent progression of atherosclerosis. The antiplatelet agent cilostazol, which has diverse antiatherogenic properties, has also been shown to reduce restenosis in previous clinical trials. Recent experimental studies have suggested potential synergy between probucol and cilostazol in preventing atherosclerosis, possibly by suppressing inflammatory reactions and promoting cholesterol efflux. Methods/design The Synergistic Effect of combination therapy with Cilostazol and probUcol on plaque stabilization and lesion REgression (SECURE study is designed as a double-blind, randomised, controlled, multicenter clinical trial to investigate the effect of cilostazol and probucol combination therapy on plaque volume and composition in comparison with cilostazol monotherapy using intravascular ultrasound and Virtual Histology. The primary end point is the change in the plaque volume of index intermediate lesions between baseline and 9-month follow-up. Secondary endpoints include change in plaque composition, neointimal growth after implantation of stents at percutaneous coronary intervention target lesions, and serum levels of lipid components and biomarkers related to atherosclerosis and inflammation. A total of 118 patients will be included in the study. Discussion The SECURE study will deliver important information on the effects of combination therapy on lipid composition and biomarkers related to atherosclerosis, thereby providing insight into the mechanisms underlying the prevention of atherosclerosis progression by cilostazol and probucol. Trial registration number ClinicalTrials (NCT: NCT01031667

  16. A school-based intervention incorporating smartphone technology to improve health-related fitness among adolescents: rationale and study protocol for the NEAT and ATLAS 2.0 cluster randomised controlled trial and dissemination study

    Lubans, David R; Smith, Jordan J; Peralta, Louisa R; Plotnikoff, Ronald C; Okely, Anthony D; Salmon, Jo; Eather, Narelle; Dewar, Deborah L; Kennedy, Sarah; Lonsdale, Chris; Hilland, Toni A; Estabrooks, Paul; Finn, Tara L; Pollock, Emma; Morgan, Philip J

    2016-01-01

    Introduction Physical inactivity has been described as a global pandemic. Interventions aimed at developing skills in lifelong physical activities may provide the foundation for an active lifestyle into adulthood. In general, school-based physical activity interventions targeting adolescents have produced modest results and few have been designed to be ‘scaled-up’ and disseminated. This study aims to: (1) assess the effectiveness of two physical activity promotion programmes (ie, NEAT and ATLAS) that have been modified for scalability; and (2) evaluate the dissemination of these programmes throughout government funded secondary schools. Methods and analysis The study will be conducted in two phases. In the first phase (cluster randomised controlled trial), 16 schools will be randomly allocated to the intervention or a usual care control condition. In the second phase, the Reach, Effectiveness, Adoption, Implementation and Maintenance (Re-AIM) framework will be used to guide the design and evaluation of programme dissemination throughout New South Wales (NSW), Australia. In both phases, teachers will be trained to deliver the NEAT and ATLAS programmes, which will include: (1) interactive student seminars; (2) structured physical activity programmes; (3) lunch-time fitness sessions; and (4) web-based smartphone apps. In the cluster RCT, study outcomes will be assessed at baseline, 6 months (primary end point) and 12-months. Muscular fitness will be the primary outcome and secondary outcomes will include: objectively measured body composition, cardiorespiratory fitness, flexibility, resistance training skill competency, physical activity, self-reported recreational screen-time, sleep, sugar-sweetened beverage and junk food snack consumption, self-esteem and well-being. Ethics and dissemination This study has received approval from the University of Newcastle (H-2014-0312) and the NSW Department of Education (SERAP: 2012121) human research ethics committees. This

  17. ELSID-Diabetes study-evaluation of a large scale implementation of disease management programmes for patients with type 2 diabetes. Rationale, design and conduct – a study protocol [ISRCTN08471887

    Gensichen Jochen

    2005-10-01

    Full Text Available Background Diabetes model projects in different regions of Germany including interventions such as quality circles, patient education and documentation of medical findings have shown improvements of HbA1c levels, blood pressure and occurrence of hypoglycaemia in before-after studies (without control group. In 2002 the German Ministry of Health defined legal regulations for the introduction of nationwide disease management programs (DMP to improve the quality of care in chronically ill patients. In April 2003 the first DMP for patients with type 2 diabetes was accredited. The evaluation of the DMP is essential and has been made obligatory in Germany by the Fifth Book of Social Code. The aim of the study is to assess the effectiveness of DMP by example of type 2 diabetes in the primary care setting of two German federal states (Rheinland-Pfalz and Sachsen-Anhalt. Methods/Design The study is three-armed: a prospective cluster-randomized comparison of two interventions (DMP 1 and DMP 2 against routine care without DMP as control group. In the DMP group 1 the patients are treated according to the current situation within the German-Diabetes-DMP. The DMP group 2 represents diabetic care within ideally implemented DMP providing additional interventions (e.g. quality circles, outreach visits. According to a sample size calculation a sample size of 200 GPs (each GP including 20 patients will be required for the comparison of DMP 1 and DMP 2 considering possible drop-outs. For the comparison with routine care 4000 patients identified by diabetic tracer medication and age (> 50 years will be analyzed. Discussion This study will evaluate the effectiveness of the German Diabetes-DMP compared to a Diabetes-DMP providing additional interventions and routine care in the primary care setting of two different German federal states.

  18. Rationale, design and methods for a community-based study of clustering and cumulative effects of chronic disease processes and their effects on ageing: the Busselton healthy ageing study

    James, Alan; Hunter, Michael; Straker, Leon; Beilby, John; Bucks, Romola; Davis, Tim; Eikelboom, Robert H; Hillman, David; Hui, Jennie; Hung, Joe; Knuiman, Matthew; Mackey, David A.; Newton, Robert U; Palmer, Lyle J; Musk, AW Bill

    2013-01-01

    Background The global trend of increased life expectancy and increased prevalence of chronic and degenerative diseases will impact on health systems. To identify effective intervention and prevention strategies, greater understanding of the risk factors for and cumulative effects of chronic disease processes and their effects on function and quality of life is needed. The Busselton Healthy Ageing Study aims to enhance understanding of ageing by relating the clustering and interactions of comm...

  19. A prospective randomised cross-over study of the effect of insulin analogues and human insulin on the frequency of severe hypoglycaemia in patients with type 1 diabetes and recurrent hypoglycaemia (the HypoAna trial): study rationale and design

    2012-01-01

    Background Severe hypoglycaemia still represents a significant problem in insulin-treated diabetes. Most patients do not experience severe hypoglycaemia often. However, 20% of patients with type 1 diabetes experience recurrent severe hypoglycaemia corresponding to at least two episodes per year. The effect of insulin analogues on glycaemic control has been documented in large trials, while their effect on the frequency of severe hypoglycaemia is less clear, especially in patients with recurrent severe hypoglycaemia. The HypoAna Trial is designed to investigate whether short-acting and long-acting insulin analogues in comparison with human insulin are superior in reducing the occurrence of severe hypoglycaemic episodes in patients with recurrent hypoglycaemia. This paper reports the study design of the HypoAna Trial. Methods/design The study is a Danish two-year investigator-initiated, prospective, randomised, open, blinded endpoint (PROBE), multicentre, cross-over trial investigating the effect of insulin analogues versus human insulin on the frequency of severe hypoglycaemia in subjects with type 1 diabetes. Patients are randomised to treatment with basal-bolus therapy with insulin detemir / insulin aspart or human NPH insulin / human regular insulin in random order. The major inclusion criterion is history of two or more episodes of severe hypoglycaemia in the preceding year. Discussion In contrast to almost all other studies in this field the HypoAna Trial includes only patients with major problems with hypoglycaemia. The HypoAna Trial will elucidate whether basal-bolus regimen with short-acting and long-acting insulin analogues in comparison with human insulin are superior in reducing occurrence of severe hypoglycaemic episodes in hypoglycaemia prone patients with type 1 diabetes. http://www.clinicaltrials.gov: NCT00346996. PMID:22727048

  20. A prospective randomised cross-over study of the effect of insulin analogues and human insulin on the frequency of severe hypoglycaemia in patients with type 1 diabetes and recurrent hypoglycaemia (the HypoAna trial: study rationale and design

    Kristensen Peter

    2012-06-01

    Full Text Available Abstract Background Severe hypoglycaemia still represents a significant problem in insulin-treated diabetes. Most patients do not experience severe hypoglycaemia often. However, 20% of patients with type 1 diabetes experience recurrent severe hypoglycaemia corresponding to at least two episodes per year. The effect of insulin analogues on glycaemic control has been documented in large trials, while their effect on the frequency of severe hypoglycaemia is less clear, especially in patients with recurrent severe hypoglycaemia. The HypoAna Trial is designed to investigate whether short-acting and long-acting insulin analogues in comparison with human insulin are superior in reducing the occurrence of severe hypoglycaemic episodes in patients with recurrent hypoglycaemia. This paper reports the study design of the HypoAna Trial. Methods/design The study is a Danish two-year investigator-initiated, prospective, randomised, open, blinded endpoint (PROBE, multicentre, cross-over trial investigating the effect of insulin analogues versus human insulin on the frequency of severe hypoglycaemia in subjects with type 1 diabetes. Patients are randomised to treatment with basal-bolus therapy with insulin detemir / insulin aspart or human NPH insulin / human regular insulin in random order. The major inclusion criterion is history of two or more episodes of severe hypoglycaemia in the preceding year. Discussion In contrast to almost all other studies in this field the HypoAna Trial includes only patients with major problems with hypoglycaemia. The HypoAna Trial will elucidate whether basal-bolus regimen with short-acting and long-acting insulin analogues in comparison with human insulin are superior in reducing occurrence of severe hypoglycaemic episodes in hypoglycaemia prone patients with type 1 diabetes. http://www.clinicaltrials.gov: NCT00346996.

  1. Risk and Determinants of Dementia in Patients with Mild Cognitive Impairment and Brain Subcortical Vascular Changes: A Study of Clinical, Neuroimaging, and Biological Markers—The VMCI-Tuscany Study: Rationale, Design, and Methodology

    Anna Poggesi

    2012-01-01

    Full Text Available Dementia is one of the most disabling conditions. Alzheimer’s disease and vascular dementia (VaD are the most frequent causes. Subcortical VaD is consequent to deep-brain small vessel disease (SVD and is the most frequent form of VaD. Its pathological hallmarks are ischemic white matter changes and lacunar infarcts. Degenerative and vascular changes often coexist, but mechanisms of interaction are incompletely understood. The term mild cognitive impairment defines a transitional state between normal ageing and dementia. Pre-dementia stages of VaD are also acknowledged (vascular mild cognitive impairment, VMCI. Progression relates mostly to the subcortical VaD type, but determinants of such transition are unknown. Variability of phenotypic expression is not fully explained by severity grade of lesions, as depicted by conventional MRI that is not sensitive to microstructural and metabolic alterations. Advanced neuroimaging techniques seem able to achieve this. Beside hypoperfusion, blood-brain-barrier dysfunction has been also demonstrated in subcortical VaD. The aim of the Vascular Mild Cognitive Impairment Tuscany Study is to expand knowledge about determinants of transition from mild cognitive impairment to dementia in patients with cerebral SVD. This paper summarizes the main aims and methodological aspects of this multicenter, ongoing, observational study enrolling patients affected by VMCI with SVD.

  2. Rationale and design of a multicenter prospective cohort study for the eVALuation and monitoring of HPV infections and relATEd cervical diseases in high-risk women (VALHIDATE study

    Orlando Giovanna

    2012-05-01

    Full Text Available Abstract Background Pap screening, an effective method for cervical cancer prevention, is now supported by molecular human papillomavirus (HPV testing. Recently commercialised preventive vaccines also provide new tools for the primary prevention of cervical cancer. To determine appropriate prevention strategies, the Health General Direction, Lombardy Region, funded a project that aims to characterize and monitor HPV infections and related cervical diseases in high-risk women. Methods/design VALHIDATE is a 5-year multicentre open prospective cohort study. It will recruit 7000 consenting women aged 13–65 years to provide information about the local biomolecular epidemiology of HPV infection and cervical diseases in high-risk women recruited from nine clinical centres and one faith-based organisation. The study will estimate the overall and type-specific prevalence of HPV infection and cervical abnormalities. It also aims to compare standard Pap screening with biomolecular screening, and to assist in the design of targeted regional prevention programs directed specifically at high-risk groups. Three groups of high-risk women: 1000 HIV-infected women (aged 26–65 years, 1000 recent migrant women (aged 26–65 years and 3000 young women (aged 13–26 years and 1 control group: 2000 women (aged 26–45 years attending a spontaneous screening program, will be recruited. Sample sizes will be revised after the first year. Adult participants will undergo conventional cervical cytology, HPV DNA screening and genotyping. Paediatric participants will undergo HPV DNA testing and genotyping of urine samples. HPV DNA, cytological abnormalities and HPV types will be analysed according to demographic, epidemiological, behavioural, and clinical data collected in an electronic case report form. Overall and stratified prevalences will be estimated to analyse the associations between HPV infection and selected characteristics. Logistic regression models

  3. Rationale and design of a multicenter prospective cohort study for the eVALuation and monitoring of HPV infections and relATEd cervical diseases in high-risk women (VALHIDATE study)

    Pap screening, an effective method for cervical cancer prevention, is now supported by molecular human papillomavirus (HPV) testing. Recently commercialised preventive vaccines also provide new tools for the primary prevention of cervical cancer. To determine appropriate prevention strategies, the Health General Direction, Lombardy Region, funded a project that aims to characterize and monitor HPV infections and related cervical diseases in high-risk women. VALHIDATE is a 5-year multicentre open prospective cohort study. It will recruit 7000 consenting women aged 13–65 years to provide information about the local biomolecular epidemiology of HPV infection and cervical diseases in high-risk women recruited from nine clinical centres and one faith-based organisation. The study will estimate the overall and type-specific prevalence of HPV infection and cervical abnormalities. It also aims to compare standard Pap screening with biomolecular screening, and to assist in the design of targeted regional prevention programs directed specifically at high-risk groups. Three groups of high-risk women: 1000 HIV-infected women (aged 26–65 years), 1000 recent migrant women (aged 26–65 years) and 3000 young women (aged 13–26 years) and 1 control group: 2000 women (aged 26–45 years) attending a spontaneous screening program, will be recruited. Sample sizes will be revised after the first year. Adult participants will undergo conventional cervical cytology, HPV DNA screening and genotyping. Paediatric participants will undergo HPV DNA testing and genotyping of urine samples. HPV DNA, cytological abnormalities and HPV types will be analysed according to demographic, epidemiological, behavioural, and clinical data collected in an electronic case report form. Overall and stratified prevalences will be estimated to analyse the associations between HPV infection and selected characteristics. Logistic regression models will be used to estimate crude and adjusted odds ratios. Cox

  4. Clinical trial design and rationale of the Multicenter Study of MagLev Technology in Patients Undergoing Mechanical Circulatory Support Therapy With HeartMate 3 (MOMENTUM 3) investigational device exemption clinical study protocol.

    Heatley, Gerald; Sood, Poornima; Goldstein, Daniel; Uriel, Nir; Cleveland, Joseph; Middlebrook, Don; Mehra, Mandeep R

    2016-04-01

    The HeartMate 3 left ventricular assist system (LVAS; St. Jude Medical, Inc., formerly Thoratec Corporation, Pleasanton, CA) was recently introduced into clinical trials for durable circulatory support in patients with medically refractory advanced-stage heart failure. This centrifugal, fully magnetically levitated, continuous-flow pump is engineered with the intent to enhance hemocompatibility and reduce shear stress on blood elements, while also possessing intrinsic pulsatility. Although bridge-to-transplant (BTT) and destination therapy (DT) are established dichotomous indications for durable left ventricular assist device (LVAD) support, clinical practice has challenged the appropriateness of these designations. The introduction of novel LVAD technology allows for the development of clinical trial designs to keep pace with current practices. The prospective, randomized Multicenter Study of MagLev Technology in Patients Undergoing Mechanical Circulatory Support Therapy With HeartMate 3 (MOMENTUM 3) clinical trial aims to evaluate the safety and effectiveness of the HeartMate 3 LVAS by demonstrating non-inferiority to the HeartMate II LVAS (also St. Jude Medical, Inc.). The innovative trial design includes patients enrolled under a single inclusion and exclusion criteria , regardless of the intended use of the device, with outcomes ascertained in the short term (ST, at 6 months) and long term (LT, at 2 years). This adaptive trial design includes a pre-specified safety phase (n = 30) analysis. The ST cohort includes the first 294 patients and the LT cohort includes the first 366 patients for evaluation of the composite primary end-point of survival to transplant, recovery or LVAD support free of debilitating stroke (modified Rankin score >3), or re-operation to replace the pump. As part of the adaptive design, an analysis by an independent statistician will determine whether sample size adjustment is required at pre-specified times during the study. A further 662

  5. Benefits of antioxidant supplements for knee osteoarthritis: rationale and reality.

    Grover, Ashok Kumar; Samson, Sue E

    2016-01-01

    Arthritis causes disability due to pain and inflammation in joints. There are many forms of arthritis, one of which is osteoarthritis whose prevalence increases with age. It occurs in various joints including hip, knee and hand with knee osteoarthritis being more prevalent. There is no cure for it. The management strategies include exercise, glucosamine plus chondroitin sulfate and NSAIDs. In vitro and animal studies provide a rationale for the use of antioxidant supplements for its management. This review assesses the reality of the benefits of antioxidant supplements in the management of knee osteoarthritis. Several difficulties were encountered in examining this issue: poorly conducted studies, a lack of uniformity in disease definition and diagnosis, and muddling of conclusions from attempts to isolate the efficacious molecules. The antioxidant supplements with most evidence for benefit for pain relief and function in knee osteoarthritis were based on curcumin and avocado-soya bean unsaponifiables. Boswellia and some herbs used in Ayurvedic and Chinese medicine may also be useful. The benefits of cuisines with the appropriate antioxidants should be assessed because they may be more economical and easier to incorporate into the lifestyle. PMID:26728196

  6. The rationale for and use of assessment frameworks: improving assessment and reporting quality in medical education

    Pearce, Jacob; Edwards, Daniel; Fraillon, Julian; Coates, Hamish; Canny, Benedict J.; Wilkinson, David

    2015-01-01

    An assessment framework provides a structured conceptual map of the learning outcomes of a programme of study along with details of how achievement of the outcomes can be measured. The rationale for using frameworks to underpin the targeting of essential content components is especially relevant for the medical education community. Frameworks have the capacity to improve validity and reliability in assessment, allowing test developers to more easily create robust assessment instruments. The f...

  7. Implementing the World Mental Health Survey Initiative in Portugal – rationale, design and fieldwork procedures

    XAVIER, MIGUEL; Baptista, Helena; Mendes, Jorge M; Magalhães, Pedro; Caldas-de-Almeida, José M.

    2013-01-01

    Background: The World Mental Health Survey Initiative was designed to evaluate the prevalence, the correlates, the impact and the treatment patterns of mental disorders. This paper describes the rationale and the methodological details regarding the implementation of the survey in Portugal, a country that still lacks representative epidemiological data about psychiatric disorders. Methods: The World Mental Health Survey is a cross-sectional study with a representative sample of th...

  8. Implementing the World Mental Health Survey Initiative in Portugal – rationale, design and fieldwork procedures

    XAVIER, MIGUEL; Baptista, Helena; Mendes, Jorge M; Magalhães, Pedro; Caldas-de-Almeida, José M.

    2013-01-01

    Background The World Mental Health Survey Initiative was designed to evaluate the prevalence, the correlates, the impact and the treatment patterns of mental disorders. This paper describes the rationale and the methodological details regarding the implementation of the survey in Portugal, a country that still lacks representative epidemiological data about psychiatric disorders. Methods The World Mental Health Survey is a cross-sectional study with a representative sample of the Portuguese p...

  9. When Regional Innovation Policies Meet Policy Rationales and Evidence:

    Borrás, Susana; Jordana, Jacint

    innovation policy rationales, advocating for more specialisation; likewise, greater data availability at the regional level has allowed more sophisticated assessment of innovation performance. Finally, the crisis since 2008 has had ravaging effects in some regions, with job losses and severe economic...

  10. Building "Applied Linguistic Historiography": Rationale, Scope, and Methods

    Smith, Richard

    2016-01-01

    In this article I argue for the establishment of "Applied Linguistic Historiography" (ALH), that is, a new domain of enquiry within applied linguistics involving a rigorous, scholarly, and self-reflexive approach to historical research. Considering issues of rationale, scope, and methods in turn, I provide reasons why ALH is needed and…

  11. Karl Popper and Jean Piaget: A Rationale for Constructivism

    Harlow, Steve; Cummings, Rhoda; Aberasturi, Suzanne M.

    2006-01-01

    The current faddish use of the term constructivism has taken on as many different definitions as the number of people attempting to define it. This essay clarifies the meaning of constructivism through an examination of Karl Popper's and Jean Piaget's theories. The authors provide a rationale for the use of Popper's paradigm of "Three Worlds" and…

  12. Strength Training. Rationale for Current Guidelines for Adult Fitness Programs.

    Feigenbaum, Matthew S.; Pollock, Michael L.

    1997-01-01

    Strength training is an effective method of developing musculoskeletal strength and is often prescribed for fitness, health, and for prevention and rehabilitation of orthopedic injuries. This paper describes and presents a rationale for the population-specific strength training guidelines established by major health organizations. (SM)

  13. Rationale of Early Adopters of Fossil Fuel Divestment

    Beer, Christopher Todd

    2016-01-01

    Purpose: This research uses the social science perspectives of institutions, ecological modernization and social movements to analyze the rationale used by the early-adopting universities of fossil fuel divestment in the USA. Design/methodology/approach: Through analysis of qualitative data from interviews with key actors at the universities that…

  14. Introducing ICT in Schools in England: Rationale and Consequences

    Hammond, Michael

    2014-01-01

    This paper provides a critical perspective on the attempts to promote the use of information and communication technology (ICT) in teaching and learning in England. It describes the rationale given for the introduction of ICT in terms of its potential to impact on educational standards to contribute to developing a curriculum which has more…

  15. Social Stories[TM]: A Possible Theoretical Rationale

    Reynhout, Georgina; Carter, Mark

    2011-01-01

    Social Stories[TM] are an intervention widely used with individuals with autism spectrum disorders (ASD). This paper discusses a possible theoretical rationale that might account for the purported efficacy of Social Stories[TM]. Attributes of individuals with ASD in relation to Social Story intervention including difficulties with theory of mind…

  16. Framing Involvement: Rationale Construction in an Interorganisational Collaboration

    Siegel, David J.

    2008-01-01

    An analysis of the different rationales articulated and utilized by partners in an interorganizational collaboration is the focus of this paper. The Leadership Education and Development (LEAD) Program in Business is an initiative involving 12 US universities, nearly 40 multinational corporations, a federal government agency, and a non-profit…

  17. Secondary School Students Learning from Reflections on the Rationale behind Self-Made Errors: A Field Experiment

    Heemsoth, Tim; Heinze, Aiso

    2016-01-01

    Thus far, it is unclear how students can learn most effectively from their own errors. In this study, reflections on the rationale behind self-made errors are assumed to enhance knowledge acquisition. In a field experiment with pre/post/follow-up design, the authors practiced fractions with 174 seventh- and eighth-grade students who were randomly…

  18. Rationales of a Shift towards Knowledge Economy in Jordan from the Viewpoint of Educational Experts and Relationship with Some Variables

    Al Zboon, Mohammad Saleem; Al Ahmad, Suliman Diab Ali; Al Zboon, Saleem Odeh

    2009-01-01

    The purpose of the present study was to identify rationales underlying a shift towards knowledge economy in education as perceived by the educational experts in Jordan and relationship with some variables. The random stratum sample (n = 90) consisted of educational experts representing faculty members in the Jordanian universities and top leaders…

  19. Post-ICU discharge and outcome: rationale and methods of the The French and euRopean Outcome reGistry in Intensive Care Units (FROG-ICU) observational study

    Mebazaa, Alexandre; Chiara Casadio, Maria; Azoulay, Elie; Guidet, Bertrand; Jaber, Samir; Lévy, Bruno; Payen, Didier; Vicaut, Eric; Resche-Rigon, Matthieu; Gayat, Etienne

    2015-01-01

    Background Previous studies have demonstrated that ICU (intensive care unit) survivors have decreased long-term survival rates compared to the general population. However, knowledge about how to identify ICU survivors with higher risk of death and the adjustable factors associated with mortality is still lacking. Methods and Design The FROG-ICU (the French and European Outcome Registry in Intensive Care Units) study is a prospective, observational, multicenter cohort study where ICU survivors...

  20. Polymorphisms associated with ventricular tachyarrhythmias: rationale, design, and endpoints of the 'diagnostic data influence on disease management and relation of genomics to ventricular tachyarrhythmias in implantable cardioverter/defibrillator patients (DISCOVERY)' study

    Garcia, Javier; Wieneke, Heinrich; Spencker, Sebastian; Svendsen, Jesper Hastrup; Martinez, Juan Gabriel; Strohmer, Bernhard; Toivonen, Lauri; Le Marec, Hervé; Garcia Bizzio, Javier Eduardo; Kaup, Bernd; Soykan, Orhan; Corrado, Domenico; Siffert, Winfried

    2010-01-01

    variants contributing to ventricular arrhythmias, a genome-wide association study will be conducted if sufficient a priori evidence can be gathered. In the second part of the study, associations of SNPs with ventricular arrhythmias will be sought and a search for potential new biological arrhythmic...... pathways will be investigated. As it is a diagnostic study, DISCOVERY will also investigate the impact of long-term device diagnostic data on the management of patients suffering from chronic cardiac disease as well as medical decisions made regarding their treatment....... modulate the risk for arrhythmias and sudden cardiac death, and identification of common variants could help to better identify patients at risk. The DISCOVERY study is an interventional, longitudinal, prospective, multi-centre diagnostic study that will enrol 1287 patients in approximately 80 European...

  1. Rationale and design of a randomised controlled trial evaluating the effectiveness of an exercise program to improve the quality of life of patients with heart failure in primary care : the EFICAR study protocol

    Zuazagoitia, Ana; Grandes, Gonzalo; Torcal, Jesús; Lekuona, Iñaki; Echevarria, Pilar; Gómez, Manuel A.; Domingo, Mar; De la Torre, María M.; Ramírez, José I.; Montoya, Imanol; Oyanguren, Juana; Ortega-Sánchez Pinilla, Ricardo; Martín Cantera, Carlos

    2010-01-01

    Background: Quality of life (QoL) decreases as heart failure worsens, which is one of the greatest worries of these patients. Physical exercise has been shown to be safe for people with heart failure. Previous studies have tested heterogeneous exercise programs using different QoL instruments and reported inconsistent effects on QoL. The aim of this study is to evaluate the effectiveness of a new exercise program for people with heart failure (EFICAR), additional to the recommended optimal tr...

  2. Rationale for the tinnitus retraining therapy trial

    Craig Formby

    2013-01-01

    Full Text Available The Tinnitus Retraining Therapy Trial (TRTT is a National Institutes of Health-sponsored, multi-centered, placebo-controlled, randomized trial evaluating the efficacy of tinnitus retraining therapy (TRT and its component parts, directive counseling and sound therapy, as treatments for subjective debilitating tinnitus in the military. The TRTT will enroll 228 individuals at an allocation ratio of 1:1:1 to: (1 directive counseling and sound therapy using conventional sound generators; (2 directive counseling and placebo sound generators; or (3 standard of care as administered in the military. Study centers include a Study Chair′s Office, a Data Coordinating Center, and six Military Clinical Centers with treatment and data collection standardized across all clinics. The primary outcome is change in Tinnitus Questionnaire (TQ score assessed longitudinally at 3, 6, 12, and 18-month follow-up visits. Secondary outcomes include: Change in TQ sub-scales, Tinnitus Handicap Inventory, Tinnitus Functional Index, and TRT interview visual analog scale; audiometric and psychoacoustic measures; and change in quality of life. The TRTT will evaluate TRT efficacy by comparing TRT (directive counseling and conventional sound generators with standard of care; directive counseling by comparing directive counseling plus placebo sound generators versus standard of care; and sound therapy by comparing conventional versus placebo sound generators. We hypothesize that full TRT will be more efficacious than standard of care, directive counseling and placebo sound generators more efficacious than standard of care, and conventional more efficacious than placebo sound generators in habituating the tinnitus awareness, annoyance, and impact on the study participant′s life.

  3. Supporting awareness in creative group work by exposing design rationale

    Umer Farooq

    2011-01-01

    Full Text Available When creativity is taken as a long-term, complex, and collaborative activity, support for awareness is required for group members to monitor the development of ideas, track how these ideas became narrowed, and understand how alternatives are being implemented and integrated by colleagues. In this paper, we investigate the effects of exposing design rationale to convey awareness, specifically activity awareness, in group creativity. Through evaluating a prototype, we investigate status updates that convey design rationale, and to what consequences, in small groups in fully distributed collaboration. We found that status updates are used for a variety of purposes and that participants’ comments on their collaborators’ status updates provided feedback. Overall, results suggest that participants’ awareness about their collaborators’ future plans increased over time. Majority of participants found the status updates useful, particularly those with higher metacognitive knowledge. Based on our results, two design strategies for activity awareness are proposed.

  4. Mineralized Collagen: Rationale, Current Status, and Clinical Applications

    Zhi-Ye Qiu

    2015-07-01

    Full Text Available This paper presents a review of the rationale for the in vitro mineralization process, preparation methods, and clinical applications of mineralized collagen. The rationale for natural mineralized collagen and the related mineralization process has been investigated for decades. Based on the understanding of natural mineralized collagen and its formation process, many attempts have been made to prepare biomimetic materials that resemble natural mineralized collagen in both composition and structure. To date, a number of bone substitute materials have been developed based on the principles of mineralized collagen, and some of them have been commercialized and approved by regulatory agencies. The clinical outcomes of mineralized collagen are of significance to advance the evaluation and improvement of related medical device products. Some representative clinical cases have been reported, and there are more clinical applications and long-term follow-ups that currently being performed by many research groups.

  5. Scientific rationale of Saturn's in situ exploration

    Mousis, O; Lebreton, J -P; Wurz, P; Cavalié, T; Coustenis, A; Courtin, R; Gautier, D; Helled, R; Irwin, P G J; Morse, A D; Nettelmann, N; Marty, B; Rousselot, P; Venot, O; Atkinson, D H; Waite, J H; Reh, K R; Simon-Miller, A; Atreya, S; André, N; Blanc, M; Daglis, I A; Fischer, G; Geppert, W D; Guillot, T; Hedman, M M; Hueso, R; Lellouch, E; Lunine, J I; Murray, C D; O'Donoghue, J; Rengel, M; Sanchez-Lavega, A; Schmider, F -X; Spiga, A; Spilker, T; Petit, J -M; Tiscareno, M S; Ali-Dib, M; Altwegg, K; Bouquet, A; Briois, C; Fouchet, T; Guerlet, S; Kostiuk, T; Lebleu, D; Moreno, R; Orton, G S; Poncy, J

    2014-01-01

    Remote sensing observations meet some limitations when used to study the bulk atmospheric composition of the giant planets of our solar system. A remarkable example of the superiority of in situ probe measurements is illustrated by the exploration of Jupiter, where key measurements such as the determination of the noble gases abundances and the precise measurement of the helium mixing ratio have only been made available through in situ measurements by the Galileo probe. This paper describes the main scientific goals to be addressed by the future in situ exploration of Saturn placing the Galileo probe exploration of Jupiter in a broader context and before the future probe exploration of the more remote ice giants. In situ exploration of Saturn's atmosphere addresses two broad themes that are discussed throughout this paper: first, the formation history of our solar system and second, the processes at play in planetary atmospheres. In this context, we detail the reasons why measurements of Saturn's bulk element...

  6. Rationale and radiopharmaceuticals for myocardial imaging

    Static radionuclide imaging procedures are now available for evaluating regional myocardial perfusion and for detecting acute myocardial infarction. Thallium-201, a radiopharmaceutical which possesses many of the characteristics of potassium analogs, at present is receiving the greatest attention as a regional blood flow indicator. Ischemic lesions appear as areas of decreased tracer uptake. Unfortunately, this agent is expensive, is in limited supply and has a photopeak which is low for optimum imaging. Positive infarct images can be obtained with various technetium-99m chelates. Pyrophosphate appears to be the best of the technetium compounds studied to date although the mechanism of uptake of the chelates has not yet been fully elucidated. Therefore, quantitative measurements of infarct size are not justified. As perfusion imaging and infarct imaging provide useful, complementary data, a dual tracer approach to evaluating patients with suspected coronary artery disease and/or myocardial infarction is probably justifiable

  7. Hermeneutics framework: integration of design rationale and optimizing software modules

    Aksit, Mehmet; Malakuti, Somayeh

    2015-01-01

    To tackle the evolution challenges of adaptive systems, this paper argues on the necessity of hermeneutic approaches that help to avoid too early elimination of design alternatives. This visionary paper proposes the Hermeneutics Framework, which computationally integrates a design rationale management system, an auto-adaptive control system and a reflective and modular event-driven language runtime together. The Hermeneutics Framework is, among others, suitable for implementing dynamic adapti...

  8. Familial orientations and the rationales for childbearing behaviour

    Beaujot, Roderic; Erfani, Amir

    2006-01-01

    EnglishUsing a local qualitative sample from Ontario, we explore the rationales forchildbearing behaviour across contrasting familial orientations. There are considerable similaritiesamong respondents with traditional and modernfamilial orientations in terms of the reasons for having children and the costsand values of children. Nonetheless, persons with modern orientations are morelikely to give individual related reasons for having children, and to see the valueof children in terms of perso...

  9. A theoretical rationale for flexicurity policies based on education

    Davoine, Thomas

    2015-01-01

    The paper provides a theoretical rationale for flexicurity policies, which consist of low employment protection, generous unemployment insurance and active labor market programmes. It analyzes in which conditions flexicurity can be optimal. Low employment protection encourages costly education efforts to access high productivity and high innovation sectors, with firms more likely to survive and thus not exposing much their workers to unemployment risk. Activation programmes support the reallo...

  10. The rationale for South-South trade; An Alternative Approach

    Shafaeddin, Mehdi

    2010-01-01

    Arguing that the theoretical literature on South-South trade is not satisfactory, the author provides an alternative framework and rationale for the South-South trade as a vehicle for industrialization and development of developing countries. He also applies this framework to developing countries in the Asia-Pacific region. In particular, showing that the low-income countries of the region are not benefiting much from the dynamism of the China market for their industrialization, he proposes, ...

  11. Frit valg i ældreplejen - rationaler og udfordringer

    Svendsen, Peter Emil Juhl; Hagmann, Lotte Nygaard; Johansen, Michael Urban

    2004-01-01

    Projektet omhandler de rationaler der ligger bag indførelsen af frit valg i ældreplejen, primært fra Regeringens perspektiv. Den anden store del af projektet er en analyse af fritvalgsordningerne i forhold til om disse nu også er effektive, altså om det kan betale sig at indføre fritvalgsordninger i ældreplejen eller om effektivitet bedre opnås i rent offentligt regi.

  12. Physics rationale for the engineering specifications for ZTH

    This report presents the physics rationale that established the engineering design of ZTH. The physics criteria are given and the implications regarding the engineering design are presented. Experimental and theoretical background evidence is given in support of the criteria but the justification is left to other reports and peer reviews. The physics criteria discussed here are limited to the ones deemed to be of highest engineering priority. 32 refs., 9 figs

  13. The rationale for early intervention in schizophrenia and related disorders

    Nordentoft, Merete; Jeppesen, Pia; Petersen, Lone;

    2009-01-01

    , adherence to treatment, comorbid drug abuse, relapse and readmission. Some benefits persist after cessation of the intervention. Conclusions: Early intervention in schizophrenia is justified to reduce the negative personal and social impact of prolonged periods of untreated symptoms. Furthermore, phase......Abstract Aim: To examine the rationale and evidence supporting an early intervention approach in schizophrenia. Methods: A selective literature review was conducted. Results: During the onset of schizophrenia, there is often a significant delay between the emergence of psychotic symptoms and the...

  14. Sampling in Qualitative Research: Rationale, Issues, and Methods

    Luborsky, Mark R.; Rubinstein, Robert L.

    1995-01-01

    In gerontology the most recognized and elaborate discourse about sampling is generally thought to be in quantitative research associated with survey research and medical research. But sampling has long been a central concern in the social and humanistic inquiry, albeit in a different guise suited to the different goals. There is a need for more explicit discussion of qualitative sampling issues. This article will outline the guiding principles and rationales, features, and practices of sampli...

  15. Rationale, Design, and Baseline Data of the Insulin Glargine (Lantus) Versus Insulin Detemir (Levemir) Treat-To-Target (L2T3) Study: A Multinational, Randomized Noninferiority Trial of Basal Insulin Initiation in Type 2 Diabetes

    S.G.H.A. Swinnen; F.J. Snoek; M.P. Dain; J.H. DeVries; J.B.L. Hoekstra; F. Holleman

    2009-01-01

    Objective: To discuss the design and baseline data of the Lantus (R) (sanofi-aventis, Paris, France) versus Levemir (R) (Novo Nordisk A/S, Bagsvaerd, Denmark) Treat-To-Target (L2T3) study, a multinational, randomized comparison between the basal insulin analogs insulin glargine and insulin detemir.

  16. Detection of coronary microembolization by Doppler ultrasound in patients with stable angina pectoris during percutaneous coronary interventions under an adjunctive antithrombotic therapy with abciximab: design and rationale of the High Intensity Transient Signals ReoPro (HITS-RP study

    Kretzschmar Daniel

    2012-05-01

    Full Text Available Abstract Background Embolization of atherosclerotic debris from the rupture of a vulnerable atherosclerotic plaque occurs iatrogenically during percutaneous coronary interventions (PCI and can induce myocardial necrosis. These microembolizations are detected as high intensity transient signals (HITS using intracoronary Doppler technology. Presentation of the hypothesis In the presented study we will test if abciximab (ReoPro® infusion reduces high intensity transient signals in patients with stable angina pectoris undergoing PCI in comparison to standard therapy alone. Testing the hypothesis The High Intensity Transient Signals ReoPro® (HITS-RP study will enroll 60 patients. It is a prospective, single center, randomized, double-blinded, controlled trial. The study is designed to compare the efficacy of intravenous abciximab administration for reduction of microembolization during elective PCI. Patients will be randomized in a 1:1 fashion to abciximab or placebo infusion. The primary end point of the HITS-RP-Study is the number of HITS during PCI measured by intracoronary Doppler wire. Secondary endpoints are bleeding complications, elevation of cardiac biomarkers or ECG changes after percutaneous coronary interventions, changes in coronary flow velocity reserve, hs-CRP elevation, any major adverse cardio-vascular event during one month follow-up. Implications of the hypothesis The HITS-RP-Study addresses important questions regarding the efficacy of intravenous abciximab administration in reducing microembolization and periprocedural complications in stable angina pectoris patients undergoing PCI. Trial registration The trial is registered under http://www.drks-neu.uniklinik-freiburg.de/drks_web/:DRKS00000603.

  17. Troublesome Construction: The Rationale and Risks of IIRSA

    Pitou van Dijck

    2008-10-01

    Full Text Available Latin American countries are involved in implementing a continental-wide infrastructure programme to deepen regional integration and facilitate their insertion in international markets. The IIRSA [Iniciativa para la Integración de la Infraestructura Regional Suramericana] program- me includes ten so called development hubs that may contribute to significant change in the location of economic activities in the continent as well. They may as well have a substantial impact on the environment in regions adjacent to the corridors. This study deals with the rationale and organization of the IIRSA infrastructure programme. Subsequently the study focuses on the spatial impact such corridors may have and the environmental, social and economic implication of these roads. Finally the paper deals with some critical methodological problems involved in the making of of strategic environmental assessment studies of IIRSA-related road infrastructure projects.  Resumen: Una construcción problemática: Razones y riesgos de IIRSALos países latinoamericanos están implementando un programa continental de infraestructura para profundizar la integración regional y facilitar su inserción en los mercados internacionales. El programa de IIRSA [Iniciativa para la Integración de la Infraestructura Regional Surameri cana] incluye diez centros de desarrollo que pueden contribuir a cambios importantes en la ubicación de las actividades económicas en el continente. Estos centros podrían tener un impacto substancial en el medioambiente de las regiones adyacentes a los corredores. Este estudio se ocupa de las razones y organización del programa de infraestructura de IIRSA. Luego nos concentramos en el impacto espacial que pueden tener esos corredores y las implicaciones sociales, económicas y para el medioambiente de esos caminos. Finalmente tratamos en el artículo algunos críticos problemas metodológicos en la elaboración de evaluaciones medioambientales

  18. Rationale and design of the B-PROOF study, a randomized controlled trial on the effect of supplemental intake of vitamin B12 and folic acid on fracture incidence

    van Wijngaarden Janneke P

    2011-12-01

    Full Text Available Abstract Background Osteoporosis is a major health problem, and the economic burden is expected to rise due to an increase in life expectancy throughout the world. Current observational evidence suggests that an elevated homocysteine concentration and poor vitamin B12 and folate status are associated with an increased fracture risk. As vitamin B12 and folate intake and status play a large role in homocysteine metabolism, it is hypothesized that supplementation with these B-vitamins will reduce fracture incidence in elderly people with an elevated homocysteine concentration. Methods/Design The B-PROOF (B-Vitamins for the PRevention Of Osteoporotic Fractures study is a randomized double-blind placebo-controlled trial. The intervention comprises a period of two years, and includes 2919 subjects, aged 65 years and older, independently living or institutionalized, with an elevated homocysteine concentration (≥ 12 μmol/L. One group receives daily a tablet with 500 μg vitamin B12 and 400 μg folic acid and the other group receives a placebo tablet. In both tablets 15 μg (600 IU vitamin D is included. The primary outcome of the study is osteoporotic fractures. Measurements are performed at baseline and after two years and cover bone health i.e. bone mineral density and bone turnover markers, physical performance and physical activity including falls, nutritional intake and status, cognitive function, depression, genetics and quality of life. This large multi-center project is carried out by a consortium from the Erasmus MC (Rotterdam, the Netherlands, VUmc (Amsterdam, the Netherlands and Wageningen University, (Wageningen, the Netherlands, the latter acting as coordinator. Discussion To our best knowledge, the B-PROOF study is the first intervention study in which the effect of vitamin B12 and folic acid supplementation on osteoporotic fractures is studied in a general elderly population. We expect the first longitudinal results of the B

  19. Evaluation of the appropriateness of the preclinical phase (stage A and stage B) of heart failure Management in Outpatient clinics in Italy rationale and design of the 'VASTISSIMO' study.

    Mureddu, Gian F; Nistri, Stefano; Faggiano, Pompilio; Fimiani, Biagio; Misuraca, Gianfranco; Maggi, Antonio; Gori, Anna M; Uguccioni, Massimo; Tavazzi, Luigi; Zito, Giovanni B

    2016-07-01

    Early detection of heart failure, when still preclinical, is fundamental. Therefore, it is important to assess whether preclinical heart failure management by cardiologists is adequate. The VASTISSIMO study ('EValuation of the AppropriateneSs of The preclInical phase (Stage A and Stage B) of heart failure Management in Outpatient clinics in Italy') is a prospective nationwide study aimed to evaluate the appropriateness of diagnosis and management of preclinical heart failure (stages A and B) by cardiologists working in outpatient clinics in Italy. Secondary goals are to verify if an online educational course for cardiologists can improve management of preclinical heart failure, and evaluate how well cardiologists are aware of patients' adherence to medications. The study involves 80 outpatient cardiology clinics distributed throughout Italy, affiliated either to the Hospital Cardiologists Association or to the Regional Association of Outpatient Cardiologists, and is designed with two phases of consecutive outpatient enrolment each lasting 1 month. In phase 1, physicians' awareness of the risk of heart failure and their decision-making process are recorded. Subsequently, half of the cardiologists are randomized to undergo an online educational course aimed to improve preclinical heart failure management through implementation of guideline recommendations. At the end of the course, all cardiologists are evaluated (phase 2) to see whether changes in clinical management have occurred in those who underwent the educational program versus those who did not. Patients' adherence to prescribed medications will be assessed through the Morisky Self-report Questionnaire. This study should provide valuable information about cardiologists' awareness of preclinical heart failure and the appropriateness of clinical practice in outpatient cardiology clinics in Italy. PMID:27028840

  20. Rationale and design of the Adapted Physical Activity in advanced Pancreatic Cancer patients (APACaP) GERCOR (Groupe Coopérateur Multidisciplinaire en Oncologie) trial: study protocol for a randomized controlled trial

    Neuzillet, Cindy; Vergnault, Mathieu; Bonnetain, Franck; Hammel, Pascal

    2015-01-01

    Background Exercise during chemotherapy is a promising strategy to reduce fatigue and improve health-related quality of life (HRQoL). It has been shown to be feasible and efficient in various cancers, including advanced-stage cancers. Effects of physical activity have never been explored in advanced pancreatic ductal adenocarcinoma (PDAC). We aim to evaluate the effects of an exercise intervention in this setting. Methods This randomized, national, multicenter, interventional study will exami...

  1. Rationale and design of the Kanyini guidelines adherence with the polypill (Kanyini-GAP study: a randomised controlled trial of a polypill-based strategy amongst Indigenous and non Indigenous people at high cardiovascular risk

    Usherwood Tim

    2010-08-01

    Full Text Available Abstract Background The Kanyini Guidelines Adherence with the Polypill (Kanyini-GAP Study aims to examine whether a polypill-based strategy (using a single capsule containing aspirin, a statin and two blood pressure-lowering agents amongst Indigenous and non-Indigenous people at high risk of experiencing a cardiovascular event will improve adherence to guideline-indicated therapies, and lower blood pressure and cholesterol levels. Methods/Design The study is an open, randomised, controlled, multi-centre trial involving 1000 participants at high risk of cardiovascular events recruited from mainstream general practices and Aboriginal Medical Services, followed for an average of 18 months. The participants will be randomised to one of two versions of the polypill, the version chosen by the treating health professional according to clinical features of the patient, or to usual care. The primary study outcomes will be changes, from baseline measures, in serum cholesterol and systolic blood pressure and self-reported current use of aspirin, a statin and at least two blood pressure lowering agents. Secondary study outcomes include cardiovascular events, renal outcomes, self-reported barriers to indicated therapy, prescription of indicated therapy, occurrence of serious adverse events and changes in quality-of-life. The trial will be supplemented by formal economic and process evaluations. Discussion The Kanyini-GAP trial will provide new evidence as to whether or not a polypill-based strategy improves adherence to effective cardiovascular medications amongst individuals in whom these treatments are indicated. Trial Registration This trial is registered with the Australian New Zealand Clinical Trial Registry ACTRN126080005833347.

  2. Home-based versus hospital-based cardiac rehabilitation after myocardial infarction or revascularisation: design and rationale of the Birmingham Rehabilitation Uptake Maximisation Study (BRUM: a randomised controlled trial [ISRCTN72884263

    Lane Deirdre

    2003-09-01

    Birmingham Rehabilitation Uptake Maximisation Study (BRUM study and has implications for the clinical management of these patients. A novel feature of this study is the inclusion of non-English Punjabi speakers.

  3. Cancer Health Empowerment for Living without Pain (Ca-HELP: study design and rationale for a tailored education and coaching intervention to enhance care of cancer-related pain

    Slee Christina

    2009-09-01

    Full Text Available Abstract Background Cancer-related pain is common and under-treated. This article describes a study designed to test the effectiveness of a theory-driven, patient-centered coaching intervention to improve cancer pain processes and outcomes. Methods/Design The Cancer Health Empowerment for Living without Pain (Ca-HELP Study is an American Cancer Society sponsored randomized trial conducted in Sacramento, California. A total of 265 cancer patients with at least moderate pain severity (Worst Pain Numerical Analog Score >=4 out of 10 or pain-related impairment (Likert score >= 3 out of 5 were randomly assigned to receive tailored education and coaching (TEC or educationally-enhanced usual care (EUC; 258 received at least one follow-up assessment. The TEC intervention is based on social-cognitive theory and consists of 6 components (assess, correct, teach, prepare, rehearse, portray. Both interventions were delivered over approximately 30 minutes just prior to a scheduled oncology visit. The majority of visits (56% were audio-recorded for later communication coding. Follow-up data including outcomes related to pain severity and impairment, self-efficacy for pain control and for patient-physician communication, functional status and well-being, and anxiety were collected at 2, 6, and 12 weeks. Discussion Building on social cognitive theory and pilot work, this study aims to test the hypothesis that a brief, tailored patient activation intervention will promote better cancer pain care and outcomes. Analyses will focus on the effects of the experimental intervention on pain severity and impairment (primary outcomes; self-efficacy and quality of life (secondary outcomes; and relationships among processes and outcomes of cancer pain care. If this model of coaching by lay health educators proves successful, it could potentially be implemented widely at modest cost. Trial Registration [Clinical Trials Identifier: NCT00283166

  4. The impact of iron supplementation efficiency in female blood donors with a decreased ferritin level and no anaemia. Rationale and design of a randomised controlled trial: a study protocol

    Tissot Jean-Daniel

    2009-01-01

    Full Text Available Abstract Background There is no recommendation to screen ferritin level in blood donors, even though several studies have noted the high prevalence of iron deficiency after blood donation, particularly among menstruating females. Furthermore, some clinical trials have shown that non-anaemic women with unexplained fatigue may benefit from iron supplementation. Our objective is to determine the clinical effect of iron supplementation on fatigue in female blood donors without anaemia, but with a mean serum ferritin ≤ 30 ng/ml. Methods/Design In a double blind randomised controlled trial, we will measure blood count and ferritin level of women under age 50 yr, who donate blood to the University Hospital of Lausanne Blood Transfusion Department, at the time of the donation and after 1 week. One hundred and forty donors with a ferritin level ≤ 30 ng/ml and haemoglobin level ≥ 120 g/l (non-anaemic a week after the donation will be included in the study and randomised. A one-month course of oral ferrous sulphate (80 mg/day of elemental iron will be introduced vs. placebo. Self-reported fatigue will be measured using a visual analogue scale. Secondary outcomes are: score of fatigue (Fatigue Severity Scale, maximal aerobic power (Chester Step Test, quality of life (SF-12, and mood disorders (Prime-MD. Haemoglobin and ferritin concentration will be monitored before and after the intervention. Discussion Iron deficiency is a potential problem for all blood donors, especially menstruating women. To our knowledge, no other intervention study has yet evaluated the impact of iron supplementation on subjective symptoms after a blood donation. Trial registration NCT00689793

  5. Coronary atherosclerosis in outlier subjects at the opposite extremes of traditional risk factors: Rationale and preliminary results of the Coronary Atherosclerosis in outlier subjects: Protective and novel Individual Risk factors Evaluation (CAPIRE) study.

    Magnoni, Marco; Andreini, Daniele; Gorini, Marco; Moccetti, Tiziano; Modena, Maria Grazia; Canestrari, Mauro; Berti, Sergio; Casolo, Giancarlo; Gabrielli, Domenico; Marraccini, Paolo; Pontone, Gianluca; Masson, Serge; Latini, Roberto; Maggioni, Aldo Pietro; Maseri, Attilio

    2016-03-01

    Although it is generally accepted that cardiac ischemic events develop when coronary atherosclerosis (coronary artery disease [CAD]) has reached a critical threshold, this is true only to a first approximation. Indeed, there are patients with severe CAD who do not develop ischemic events; conversely, at the other extreme, individuals with minimal CAD may do. Similar exceptions to this paradigm include patients with diffuse CAD with a low risk factor (RF) profile and others with multiple RFs who develop only mild or no CAD. Therefore, the CAPIRE project was designed to investigate whether the specific study of these extreme outlier populations could provide clues for identification of yet unknown risk or protective factors for CAD and ischemic events. In the CAPIRE study, 481 subjects without previous symptoms or history of ischemic heart disease and normal left ventricular systolic function undergoing coronary computed tomography angiography have been selected based on coronary computed tomography angiography findings and cardiovascular RF profile. Therefore, in the whole population, 2 extreme outlier populations have been identified: (1) subjects with no CAD despite multiple RFs, and (2) at the opposite extreme, subjects with diffuse CAD despite a low-risk profile. Each subject has been characterized by clinical, anatomical imaging variables of CAD and baseline circulating biomarkers. Blood samples were collected and stored in a biological bank for further advanced investigations. The project is designed as a prospective, observational, international multicenter study with an initial cross-sectional analysis of clinical, imaging, and biomolecular variables in the selected groups and a longitudinal 5-year follow-up. PMID:26920592

  6. Rationale and design of dal-PLAQUE: A study assessing efficacy and safety of dalcetrapib on progression or regression of atherosclerosis using magnetic resonance imaging and 18F-fluorodeoxyglucose positron emission tomography/computed tomography

    Fayad, Zahi A.; Mani, Venkatesh; Woodward, Mark; Kallend, David; Bansilal, Sameer; Pozza, Joseph; Burgess, Tracy; Fuster, Valentin; Rudd, James H. F.; Tawakol, Ahmed; Farkouh, Michael E.

    2014-01-01

    dal-PLAQUE is a placebo-controlled multicenter study designed to assess the effect of dalcetrapib on imaging measures of plaque inflammation and plaque burden. dal-PLAQUE is a multimodality imaging study in the context of the large dal-HEART Program. Decreased high-density lipoprotein cholesterol is linked to increased risk of coronary heart disease (CHD). Dalcetrapib, a compound that increases high-density lipoprotein cholesterol by modulating cholesteryl ester transfer protein, is being studied to assess if it can reduce the progression of atherosclerotic disease and thereby decrease cardiovascular morbidity and mortality. Patients with CHD or CHD-risk equivalents were randomized to receive 600 mg dalcetrapib or placebo daily for 24 months, in addition to conventional lipid-lowering medication and other medications for cardiovascular risk factors. The primary outcomes are the effect of dalcetrapib on 18F-fluorodeoxyglucose positron emission tomography target-to-background ratio after 6 months and magnetic resonance imaging (MRI) plaque burden (wall area, wall thickness, total vessel area, and wall area/total vessel area ratio) after 12 months. Secondary objectives include positron emission tomography target-to-background ratio at 3 months and MRI plaque burden at 6 and 24 months; plaque composition at 6, 12, and 24 months; and aortic compliance at 6 months. A tertiary objective is to examine the dynamic contrast-enhanced MRI parameters of plaque neovascularization. In total, 189 subjects entered screening, and 130 were randomized. dal-PLAQUE will provide important information on the effects of dalcetrapib on markers of inflammation and atherosclerotic plaque burden and, thereby, on the safety of cholesteryl ester transfer protein modulation with dalcetrapib. Results are expected in 2011. PMID:21835280

  7. Rivaroxaban-once daily, oral, direct factor Xa inhibition compared with vitamin K antagonism for prevention of stroke and Embolism Trial in Atrial Fibrillation: rationale and design of the ROCKET AF study

    NN, NN

    2010-01-01

    in advanced development as an alternative to warfarin for the prevention and treatment of thromboembolic disorders. METHODS: ROCKET AF is a randomized, double-blind, double-dummy, event-driven trial, which aims to establish the noninferiority of rivaroxaban compared with warfarin in patients with...... nonmajor bleeding events. Over 14,000 patients have been randomized at 1,100 sites across 45 countries, and will be followed until 405 primary outcome events are observed. CONCLUSION: The ROCKET AF study will determine the efficacy and safety of rivaroxaban as an alternative to warfarin for the prevention...

  8. Rationale and design of a randomised controlled trial evaluating the effectiveness of an exercise program to improve the quality of life of patients with heart failure in primary care: The EFICAR study protocol

    de la Torre Maria M

    2010-01-01

    Full Text Available Abstract Background Quality of life (QoL decreases as heart failure worsens, which is one of the greatest worries of these patients. Physical exercise has been shown to be safe for people with heart failure. Previous studies have tested heterogeneous exercise programs using different QoL instruments and reported inconsistent effects on QoL. The aim of this study is to evaluate the effectiveness of a new exercise program for people with heart failure (EFICAR, additional to the recommended optimal treatment in primary care, to improve QoL, functional capacity and control of cardiovascular risk factors. Methods/Design Multicenter clinical trial in which 600 patients with heart failure in NYHA class II-IV will be randomized to two parallel groups: EFICAR and control. After being recruited, through the reference cardiology services, in six health centres from the Spanish Primary Care Prevention and Health Promotion Research Network (redIAPP, patients are followed for 1 year after the beginning of the intervention. Both groups receive the optimized treatment according to the European Society of Cardiology guidelines. In addition, the EFICAR group performs a 3 month supervised progressive exercise program with an aerobic (high-intensity intervals and a strength component; and the programme continues linked with community resources for 9 months. The main outcome measure is the change in health-related QoL measured by the SF-36 and the Minnesota Living with Heart Failure Questionnaires at baseline, 3, 6 and 12 months. Secondary outcomes considered are changes in functional capacity measured by the 6-Minute Walking Test, cardiac structure (B-type natriuretic peptides, muscle strength and body composition. Both groups will be compared on an intention to treat basis, using multi-level longitudinal mixed models. Sex, age, social class, co-morbidity and cardiovascular risk factors will be considered as potential confounding and predictor variables. Discussion

  9. Efficacy of n-3 polyunsaturated fatty acids and feasibility of optimizing preventive strategies in patients at high cardiovascular risk: rationale, design and baseline characteristics of the Rischio and Prevenzione study, a large randomised trial in general practice

    2010-05-01

    Full Text Available Abstract Background The optimization of preventive strategies in patients at high risk of cardiovascular events and the evaluation of bottlenecks and limitations of transferring current guidelines to the real world of clinical practice are important limiting steps to cardiovascular prevention. Treatment with n-3 polyunsaturated fatty acids improves prognosis after myocardial infarction, but evidence of this benefit is lacking in patients at high cardiovascular risk, but without a history of myocardial infarction. Methods/design Patients were eligible if their general practitioner (GP considered them at high cardiovascular risk because of a cardiovascular disease other than myocardial infarction, or multiple risk factors (at least four major risk factors in non-diabetic patients and one in diabetics. Patients were randomly allocated to treatment with n-3 polyunsaturated fatty acids (1 g daily or placebo in a double-blind study and followed up for five years by their GPs to assess the efficacy of the treatment in preventing cardiovascular mortality (including sudden death and hospitalization for cardiovascular reasons. The secondary, epidemiological, aim of the study is to assess whether it is feasible to adopt current guidelines in everyday clinical practice, with a view to optimizing all the available preventive strategies in people at high cardiovascular risk. A nation-wide network of 860 GPs admitted 12,513 patients to the study between February 2004 and March 2007. The mean age was 64 years and 62% were males. Diabetes mellitus plus one or more cardiovascular risk factors was the main inclusion criterion (47%. About 30% of patients were included because of a history of atherosclerotic cardiovascular disease, 21% for four or more risk factors, and less than 1% for other reasons. Discussion The Rischio and Prevenzione (R&P project provides a feasible model to test the efficacy of n-3 polyunsaturated fatty acid therapy in patients at high

  10. A cluster randomized trial to assess the impact of clinical pathways for patients with stroke: rationale and design of the Clinical Pathways for Effective and Appropriate Care Study [NCT00673491

    Barbieri Antonella

    2008-11-01

    Full Text Available Abstract Background Patients with stroke should have access to a continuum of care from organized stroke units in the acute phase, to appropriate rehabilitation and secondary prevention measures. Moreover to improve the outcomes for acute stroke patients from an organizational perspective, the use of multidisciplinary teams and the delivery of continuous stroke education both to the professionals and to the public, and the implementation of evidence-based stroke care are recommended. Clinical pathways are complex interventions that can be used for this purpose. However in stroke care the use of clinical pathways remains questionable because little prospective controlled data has demonstrated their effectiveness. The purpose of this study is to determine whether clinical pathways could improve the quality of the care provided to the patients affected by stroke in hospital and through the continuum of the care. Methods Two-arm, cluster-randomized trial with hospitals and rehabilitation long-term care facilities as randomization units. 14 units will be randomized either to arm 1 (clinical pathway or to arm 2 (no intervention, usual care. The sample will include 238 in each group, this gives a power of 80%, at 5% significance level. The primary outcome measure is 30-days mortality. The impact of the clinical pathways along the continuum of care will also be analyzed by comparing the length of hospital stay, the hospital re-admissions rates, the institutionalization rates after hospital discharge, the patients' dependency levels, and complication rates. The quality of the care provided to the patients will be assessed by monitoring the use of diagnostic and therapeutic procedures during hospital stay and rehabilitation, and by the use of key quality indicators at discharge. The implementation of organized care will be also evaluated. Conclusion The management of patients affected by stroke involves the expertise of several professionals, which can

  11. Study Design and Rationale for the Phase 3 Clinical Development Program of Enobosarm, a Selective Androgen Receptor Modulator, for the Prevention and Treatment of Muscle Wasting in Cancer Patients (POWER Trials).

    Crawford, Jeffrey; Prado, Carla M M; Johnston, Mary Ann; Gralla, Richard J; Taylor, Ryan P; Hancock, Michael L; Dalton, James T

    2016-06-01

    subject must have ≥10 % improvement in physical function compared to baseline. To meet the definition of response on LBM, a subject must have demonstrated no loss of LBM compared with baseline. Secondary endpoints include durability of response assessed at day 147 in those responding at day 84. A combined overall survival analysis for both studies is considered a key secondary safety endpoint. The POWER trials design was established with extensive clinical input and collaboration with regulatory agencies. The efficacy endpoints are a result of this feedback and discussion of the threshold for clinical benefit in patients at risk for muscle wasting. Full results from these studies will soon be published and will further guide the development of future anabolic trials. Clinical Trial ID: NCT01355484. https://clinicaltrials.gov/ct2/show/NCT01355484 , NCT01355497. https://clinicaltrials.gov/ct2/show/NCT01355497?term=g300505&rank=1 . PMID:27138015

  12. The Irritable Bowel Syndrome Outcome Study (IBSOS): rationale and design of a randomized, placebo-controlled trial with 12 month follow up of self- versus clinician-administered CBT for moderate to severe irritable bowel syndrome.

    Lackner, Jeffrey M; Keefer, Laurie; Jaccard, James; Firth, Rebecca; Brenner, Darren; Bratten, Jason; Dunlap, Laura J; Ma, Changxing; Byroads, Mark

    2012-11-01

    Irritable bowel syndrome is a common, oftentimes disabling, gastrointestinal disorder whose full range of symptoms has no satisfactory medical or dietary treatment. One of the few empirically validated treatments includes a specific psychological therapy called cognitive behavior therapy which, if available, is typically administered over several months by trained practitioners in tertiary care settings. There is an urgent need to develop more efficient versions of CBT that require minimal professional assistance but retain the efficacy profile of clinic based CBT. The Irritable Bowel Syndrome Outcome Study (IBSOS) is a multicenter, placebo-controlled randomized trial to evaluate whether a self-administered version of CBT is, at least as efficacious as standard CBT and more efficacious than an attention control in reducing core GI symptoms of IBS and its burden (e.g. distress, quality of life impairment, etc.) in moderately to severely affected IBS patients. Additional goals are to assess, at quarterly intervals, the durability of treatment response over a 12 month period; to identify clinically useful patient characteristics associated with outcome as a way of gaining an understanding of subgroups of participants for whom CBT is most beneficial; to identify theory-based change mechanisms (active ingredients) that explain how and why CBT works; and evaluate the economic costs and benefits of CBT. Between August 2010 when IBSOS began recruiting subjects and February 2012, the IBSOS randomized 171 of 480 patients. Findings have the potential to improve the health of IBS patients, reduce its social and economic costs, conserve scarce health care resources, and inform evidence-based practice guidelines. PMID:22846389

  13. Design and rationale for the PREVAIL study: effect of e-Health individually tailored encouragements to physical exercise on aerobic fitness among adolescents with congenital heart disease--a randomized clinical trial.

    Klausen, Susanne Hwiid; Mikkelsen, Ulla Ramer; Hirth, Asle; Wetterslev, Jørn; Kjærgaard, Hanne; Søndergaard, Lars; Andersen, Lars Louis

    2012-04-01

    Intensive exercise may be an important part of rehabilitation in patients with congenital heart disease (CHD). However, performing regular physical exercise is challenging for many adolescent patients. Consequently, effective exercise encouragements may be needed. Little is known on the effect of e-Health encouragements on physical fitness, physical activity, and health-related quality of life in adolescents. This trial is a nationwide interactive e-Health rehabilitation study lasting 1 year, centered on interactive use of mobile phone and Internet technology. We hypothesize that e-Health encouragements and interactive monitoring of intensive exercise for 1 year can improve physical fitness, physical activity, and health-related quality of life. Two hundred sixteen adolescents (age, 13-16 years) with surgically corrected complex CHD but without significant hemodynamic residual defects and no restrictions to participate in physical activity are in the process of being enrolled by invitation after informed consent. Physical fitness is measured as the maximal oxygen uptake (Vo(2)) at baseline and after 12 months by an assessor blinded to the randomization group. After baseline testing, the patients are 1:1 randomized to an intervention group or a control group. Individually fully automated tailored e-Health encouragements--SMS, Internet, and mobile applications--aimed at increasing physical activity are delivered to the participants in the intervention group once a week. The Bandura's Social Cognitive Theory inspires the behavioral theoretical background. The e-Health intervention and the Godfrey cycle ergometer protocol have been feasibility tested and seem applicable to adolescents with CHD. The trial is expected to contribute with new knowledge regarding how physical activity in adolescents with CHD can be increased and, possibly, comorbidity be reduced. PMID:22520519

  14. Review of platinum complex biochemistry suggests a rationale for combined platinum-radiotherapy

    A review of the biochemistry of platinum coordination complexes represented by the parent complex cis-dichlorodiammineplatinum II, (cis-DDP), indicates that this family of chemotherapeutic agents binds to DNA affording the potential for interactions with other therapeutic modalities. Results of relatively recent studies in bacteria, mammalian cell cultures and in animal tumor systems suggest that these platinum complexes interact with irradiation, thereby producing cell kill that may be greater than additive. A rationale is provided for the combination of cis-DDP and other platinum complexes with radiotherapy in the treatment of cancer

  15. Rationale and study protocol for the supporting children’s outcomes using rewards, exercise and skills (SCORES group randomized controlled trial: A physical activity and fundamental movement skills intervention for primary schools in low-income communities

    Lubans David R

    2012-06-01

    and active. The findings from the study may be used to guide teacher pre-service education, professional learning and school policy in primary schools. Trial registration Australian New Zealand Clinical Trials Registry No: ACTRN12611001080910

  16. Reflecting on the Rationales for String Study in Schools

    Brenner, Brenda

    2010-01-01

    This essay will address the question of the value of string education by first examining arguments offered on behalf of string education in schools, and noting their somewhat mixed value. Then a set of arguments will be presented that may have greater promise. The focal point will be the establishment of excellence in string teaching and playing.…

  17. An ecological dynamics rationale to explain home advantage in professional football

    Gama, José; Dias, Gonçalo; Couceiro, Micael; Passos, Pedro; Davids, Keith; Ribeiro, João

    2016-03-01

    Despite clear findings, research on home advantage in team sports lacks a comprehensive theoretical rationale for understanding why this phenomenon is so compelling. The aim of this study was to provide an explanatory theoretical rationale in ecological dynamics for the influence of home advantage observed in research on professional football. We recorded 30 competitive matches and analyzed 13958 passes, from one highly successful team in the Portuguese Premier League, during season 2010/2011. Performance data were analyzed using the Match Analysis Software—Amisco® (version 3.3.7.25), allowing us to characterize team activity profiles. Results were interpreted from an ecological dynamics perspective, explaining how task and environmental constraints of a competitive football setting required performers to continuously co-adapt to teammate behaviors. Despite slight differences in percentage of ball possession when playing home or away, the number of passes achieved by the team, while in possession of the ball, was quite different between home or away venues. When playing at home, the number of passes performed by the team was considerably higher than when playing away. The explanation proposed in this study for a home advantage effect can be understood from studying interpersonal coordination tendencies of team sports players as agents in a complex adaptive system.

  18. Critique of rationale for transmutation of nuclear waste

    It has been suggested that nuclear transmutation could be used in the elimination or reduction of hazards from radioactive wastes. The rationale for this suggestion is the subject of this paper. The objectives of partitioning-transmutation are described. The benefits are evaluated. The author concludes that transmutation would appear at best to offer the opportunity of reducing an already low risk. This would not seem to be justifiable considering the cost. If non-radiological risks are considered, there is a negative total benefit

  19. Scientific rationale for a lower radon daughter exposure

    On April 21, 1980 the Oil, Chemical and Atomic Workers Union (OCAW) submitted a petition urging the revision of the Mine Safety and Health Administration (MSHA) permissible exposure limit to radon daughters in underground mines. This petition asks for: annual worker exposure to be lowered from the current 4 WLM/year to 0.7 WLM/year; full economic protection for workers whose exposure exceeds the proposed 0.7 WLM/year; and the primary means of lowering workers' radiation exposures shall be environmental controls. The scientific rationale for the lower standard requested in the petition to the Department of Labor is presented

  20. Critique of rationale for transmutation of nuclear waste

    Smith, C.F.; Cohen, J.J.

    1980-07-01

    It has been suggested that nuclear transmutation could be used in the elimination or reduction of hazards from radioactive wastes. The rationale for this suggestion is the subject of this paper. The objectives of partitioning-transmutation are described. The benefits are evaluated. The author concludes that transmutation would appear at best to offer the opportunity of reducing an already low risk. This would not seem to be justifiable considering the cost. If non-radiological risks are considered, there is a negative total benefit. (DC)

  1. Plato's Cosmic Theology: A Rationale for a Polytheistic Astrology?

    Henriques, André

    2015-05-01

    Plato's cosmology influenced classical astronomy and religion, but was in turn influenced by the polytheistic context of its time. Throughout his texts, including the cosmological treatise Timaeus, and the discussions on the soul in the Phaedrus, Plato (c.428-c.348 BC) established what can be generalised as Platonic cosmological thought. An understanding of the philosophical and mythical levels of Platonic thought can provide a rationale for polytheistic and astrological worldviews, pointing to some cosmological continuity, alongside major shifts, from ancient Greek religion to the astrological thought of ancient astronomers such as Claudius Ptolemy.

  2. Providing a Rationale for Promoting Argument-Based Inquiry Approach to Science Education: A Deweyan Pragmatist Aesthetics Perspective

    Şevket Benhür Oral

    2012-01-01

    Argumentation in science education is a well-established and successful research programme. Key theoretical underpinnings of this approach come from situated cognition perspective, the theory of communicative action and the sociocultural perspective, language studies and social semiotics, philosophy of science studies, and developmental psychology. In this paper, it will be argued that all these theoretical frameworks that aim to provide a rationale for promoting argument-based inquiry approa...

  3. New Knowledge Network Evaluation Method for Design Rationale Management

    JING Shikai; ZHAN Hongfei; LIU Jihong; WANG Kuan; JIANG Hao; ZHOU Jingtao

    2015-01-01

    Current design rationale (DR) systems have not demonstrated the value of the approach in practice since little attention is put to the evaluation method of DR knowledge. To systematize knowledge management process for future computer-aided DR applications, a prerequisite is to provide the measure for the DR knowledge. In this paper, a new knowledge network evaluation method for DR management is presented. The method characterizes the DR knowledge value from four perspectives, namely, the design rationale structure scale, association knowledge and reasoning ability, degree of design justification support and degree of knowledge representation conciseness. The DR knowledge comprehensive value is also measured by the proposed method. To validate the proposed method, different style of DR knowledge network and the performance of the proposed measure are discussed. The evaluation method has been applied in two realistic design cases and compared with the structural measures. The research proposes the DR knowledge evaluation method which can provide object metric and selection basis for the DR knowledge reuse during the product design process. In addition, the method is proved to be more effective guidance and support for the application and management of DR knowledge.

  4. Glucocorticoid augmentation of prolonged exposure therapy: rationale and case report

    Laura Pratchett

    2010-12-01

    Full Text Available Rationale: Prolonged exposure (PE therapy has been found to reduce symptoms of posttraumatic stress disorder (PTSD; however, it is difficult for many patients to engage fully in the obligatory retelling of their traumatic experiences. This problem is compounded by the fact that habituation and cognitive restructuring – the main mechanisms through which PE is hypothesized to work – are not instantaneous processes, and often require several weeks before the distress associated with imaginal exposure abates. Case reports: Two cases are described that respectively illustrate the use of hydrocortisone and placebo, in combination with PE, for the treatment of combat-related PTSD. Based on known effects of glucocorticoids on learning and memory performance, we hypothesized that augmentation with hydrocortisone would improve the therapeutic effects of PE by hastening “new” learning and facilitating decreases in the emotional impact of fear memories during the course of treatment. The veteran receiving hydrocortisone augmentation of PE displayed an accelerated and ultimately greater decline in PTSD symptoms than the veteran receiving placebo. Conclusions: While no general conclusion can be derived from comparison of two patients, the findings are consistent with the rationale for augmentation. These case reports support the potential for an appropriately designed and powered clinical trial to examine the efficacy of glucocorticoids in augmenting the effects of psychotherapy for PTSD.

  5. Commercially-driven human interplanetary propulsion systems: Rationale, concept, technology, and performance requirements

    Previous studies of human interplanetary missions are largely characterized by long trip times, limited performance capabilities, and enormous costs. Until these missions become dramatically more open-quote open-quote commercial-friendly close-quote close-quote, their funding source and rationale will be restricted to national governments and their political/scientific interests respectively. A rationale is discussed for human interplanetary space exploration predicated on the private sector. Space propulsion system requirements are identified for interplanetary transfer times of no more than a few weeks/months to and between the major outer planets. Nuclear fusion is identified as the minimum requisite space propulsion technology. A conceptual design is described and evolutionary catalyzed-DD to DHe3 fuel cycles are proposed. Magnetic nozzles for direct thrust generation and quantifying the operational aspects of the energy exchange mechanisms between high energy reaction products and neutral propellants are identified as two of the many key supporting technologies essential to satisfying system performance requirements. Government support of focused, breakthrough technologies is recommended at funding levels appropriate to other ongoing federal research. copyright 1996 American Institute of Physics

  6. Agglomeration and Specialisation Patterns of Finnish Biotechnology. On the Search for an Economic Rationale of a Dispersed Industry Structure

    Tahvanainen, Antti-Jussi; Hermans, Raine

    2008-01-01

    This study sets out to inspect empirically whether existing theory in Geographical Economics (GE) is able to provide a rationale for the controversial and much debated structure of the highly knowledge- and research-intensive biotechnology industry in Finland. In addition to providing evidence of GE in action, we integrate the effects that active public technology policy might have on geographic structures of industries into our analysis as a novel discourse. The results provide evidence of a...

  7. RATIONALE AND PROCEDURES IN THE TEACHING OF INTENSIVE READING

    Xiong; Jincai

    1999-01-01

    This paper is a product of intensive reading teaching reform practice held in Shantou Universityin 1998,under the instruction of Mr.Black(professor of New York City University).It summarises therational and procedures we used in the teaching practice of intensive reading.Modes of top-down and bot-tom-up processing are introduced,procedures such as skimming,scanning,careful reading,writing,role-playing,presentation and practice are described,particular importance is attached to group work orpair work.The rationale and procedures we put forward in this paper are not revolutionary but a combi-nation of traditional Chinese teacher-centred mode with contemporary western student-centred approachin the teaching of intensive reading in China.However,they have been proved highly efficient and prac-tical,which makes this paper worth reading.

  8. RATIONALE MANAGEMENT APPROACH IN STRESS MANAGEMENT: AN INFORMATION PERCEPTION

    V.T.R. Vijaya Kumar

    2013-01-01

    Full Text Available Occupational stress has both positive and negative impact. By tweaking stress causing factors, the positive and negative impact of occupational stress can be proscribed. By default, stressors have a degree of proportion pertaining to the type of organization. Manipulation of the existing proportion results in consideration of tradeoff among stressors. Control on job is considered as a factor of providing job satisfaction. An optimal way of affording task related information can be the availability of tools to access and assess decision information. Providing access to the precise rationale at similar instances may help the employee to get better solution, thus job satisfaction. Information by means of information systems’can be considered as primary level intervention to avoid certain role stressors.

  9. Ethical Rationale for the Ebola "Ring Vaccination" Trial Design.

    Rid, Annette; Miller, Franklin G

    2016-03-01

    The 2014 Ebola virus epidemic is the largest and most severe ever recorded. With no approved vaccines or specific treatments for Ebola, clinical trials were launched within months of the epidemic in an unprecedented show of global partnership. One of these trials used a highly innovative "ring vaccination" design. The design was chosen for operational, scientific, and ethical reasons--in particular, it was regarded as ethically superior to individually randomized placebo-controlled trials. We scrutinize the ethical rationale for the ring vaccination design. We argue that the ring vaccination design is ethical but fundamentally equivalent to placebo-controlled designs with respect to withholding a potentially effective intervention from the control group. We discuss the implications for the ongoing ring vaccination trial and future research. PMID:26794172

  10. Advanced control room evaluation: General approach and rationale

    Advanced control rooms (ACRs) for future nuclear power plants (NPPs) are being designed utilizing computer-based technologies. The US Nuclear Regulatory Commission reviews the human engineering aspects of such control rooms to ensure that they are designed to good human factors engineering principles and that operator performance and reliability are appropriately supported in order to protect public health and safety. This paper describes the rationale and general approach to the development of a human factors review guideline for ACRs. The factors influencing the guideline development are discussed, including the review environment, the types of advanced technologies being addressed, the human factors issues associated with advanced technology, and the current state-of-the-art of human factors guidelines for advanced human-system interfaces (HSIs). The proposed approach to ACR review would track the design and implementation process through the application of review guidelines reflecting four review modules: planning, design process analysis, human factors engineering review, and dynamic performance evaluation. 21 refs

  11. The Biodiversity Offsetting Dilemma: Between Economic Rationales and Ecological Dynamics

    Coralie Calvet

    2015-06-01

    Full Text Available Although many countries have included biodiversity offsetting (BO requirements in their environmental regulations over the past four decades, this mechanism has recently been the object of renewed political interest. Incorporated into the mitigation hierarchy in three steps aimed at avoiding, reducing and offsetting residual impacts on biodiversity arising from development projects, BO is promoted as the way to achieve the political goal of No Net Loss of biodiversity (NNL. The recent success of BO is mainly based on its ability to provide economic incentives for biodiversity conservation. However, the diversity of BO mechanisms (direct offsets, banking mechanism and offsetting funds and the various institutional frameworks within which they are applied generate substantial confusion about their economic and ecological implications. In this article, we first analyze the rationale for the BO approach from the welfare and ecological economics. We show that both these frameworks support the use of BO to address environmental externalities, but that they differ in how they consider the substitutability issue and levels of sustainability with regard to natural and manufactured capital, and in how they address ecological concerns. We then examine the economic and ecological performance criteria of BO from conceptual and empirical perspectives. We highlight that the three BO mechanisms involve different economic and ecological logics and inherent benefits, but also potential risks in meeting biodiversity conservation targets. We lastly investigate the ecological constraints with respect to the BO practice, and economic and organizational limitations of the BO system that may impede achievement of NNL goals. We then reveal the existence of a tension between the economic and ecological rationales in conducting BO that requires making choices about the NNL policy objectives. Finally, this article questions the place of BO in conservation policies and

  12. Rationale for hedging initiatives: Empirical evidence from the energy industry

    Dhanarajata, Srirajata

    Theory offers different rationales for hedging including (i) financial distress and bankruptcy cost, (ii) capacity to capture attractive investment opportunities, (iii) information asymmetry, (iv) economy of scale, (v) substitution for hedging, (vi) managerial risk aversion, and (vii) convexity of tax schedule. The purpose of this dissertation is to empirically test the explanatory power of the first five theoretical rationales on hedging done by oil and gas exploration and production (E&P) companies. The level of hedging is measured by the percentage of production effectively hedged, calculated based on the concept of delta and delta-gamma hedging. I employ Tobit regression, principal components, and panel data analysis on dependent and raw independent variables. Tobit regression is applied due to the fact that the dependent variable used in the analysis is non-negative. Principal component analysis helps to reduce the dimension of explanatory variables while panel data analysis combines/pools the data that is a combination of time-series and cross-sectional. Based on the empirical results, leverage level is consistently found to be a significant factor on hedging activities, either due to an attempt to avoid financial distress by the firm, or an attempt to control agency cost by debtholders, or both. The effect of capital expenditures and discretionary cash flows are both indeterminable due possibly to a potential mismatch in timing of realized cash flow items and hedging decision. Firm size is found to be positively related to hedging supporting economy of scale hypothesis, which is introduced in past literature, as well as the argument that large firm usually are more sophisticated and should be more willing and more comfortable to use hedge instruments than smaller firms.

  13. Organ Donation in the 50+ Age Demographic: Survey Results on Decision Rationale and Information Preferences.

    Tartaglia, Alexander; Dodd-McCue, Diane; Myer, Kevin A; Mullins, Andrew

    2016-09-01

    The rate of organ donation by older potential donors is significantly declining even though recent studies show positive clinical outcomes with organs transplanted from older donors. This study examined the 50+ age demographic to identify the rationale for donation decisions, preferred media methods of donation information delivery, and responsiveness to an age-tailored donation message. Results from 579 surveys, 87% from the 50+ age demographic, found respondents prone to self-select themselves as medically ineligible based on current medication and health status, even though they might be medically suitable donors. Their incentive to pursue additional information on donation is limited except when motivated by personal accounts within their families and communities. In addition, even when computer literate, they continue to favor the printed or spoken word for donation information delivery. The results suggest an opportunity for those working with older adults to develop more personalized, localized donation education programs targeting this age demographic. PMID:24752758

  14. Paradigms, Purpose, and the Role of the Literature: Formulating a Rationale for Qualitative Investigations

    Haverkamp, Beth E.; Young, Richard A.

    2007-01-01

    The authors have identified three areas that are central to the rationale for conducting a qualitative research project, yet which produce confusion and uncertainty for some psychologists trained in traditional research methods. In this article, they consider how philosophy of science paradigms relate to the foundational rationale for qualitative…

  15. Complementary and alternative medicine for autism spectrum disorders: rationale, safety and efficacy.

    Whitehouse, Andrew J O

    2013-09-01

    Complementary and alternative medicine is widely used for children with autism spectrum disorder, despite uncertainty regarding efficacy. This review describes complementary and alternative practices commonly used among this population, the rationale for the use of each practice, as well as the side-effect profile and evidence for efficacy. The existing evidence base indicates that melatonin can be recommended as a treatment for sleeping disturbances associated with autism spectrum disorder, while secretin can be rejected as an efficacious treatment for broader autistic symptoms. There is insufficient evidence to draw conclusions on the efficacy of modified diets, hyperbaric oxygen therapy, immune therapy, and vitamin and fatty acid supplementation. There is a clear need for methodologically rigorous studies to provide evidence-based guidance to families and clinicians regarding complementary and alternative practices for individuals with autism spectrum disorders. PMID:23682728

  16. Cognitive Defusion versus Thought Distraction: A Clinical Rationale, Training, and Experiential Exercise in Altering Psychological Impacts of Negative Self-Referential Thoughts

    Masuda, Akihiko; Feinstein, Amanda B.; Wendell, Johanna W.; Sheehan, Shawn T.

    2010-01-01

    Using two modes of intervention delivery, the present study compared the effects of a cognitive defusion strategy with a thought distraction strategy on the emotional discomfort and believability of negative self-referential thoughts. One mode of intervention delivery consisted of a clinical rationale and training (i.e., Partial condition). The…

  17. Novel pharmaceutical rationale against human lymphatic fi-larial parasite:An oxidative premise

    R.D.Sharma; P.B.Janardhana; D.Gajalakshmi; M.V.R.Reddy; K.Goswami

    2009-01-01

    Objective:Mandate from WHO has boosted up anti-filarial drug research.Diethylcarbamazine citrate (DEC) was not known for any direct effect on filarial parasites.However,recent report proposed its direct apoptotic effect.Oxidative stress has been implicated in apoptotic impact.A study was designed to explore the possibili-ty of oxidative rationale to be operative in the direct anti-filarial effect of DEC.Methods:Various doses of DEC and potent oxidant H2 O2 alone were used in vitro to check for the effects on B.malayi microfilariae,fol-lowed by the use of DEC in combination with H2 O2 .Reversal of the oxidative impact of the drug was tested u-sing the antioxidant,vitamin C and also lipid peroxidation levels in the post incubation culture supernatants were assayed.Result:As expected,DEC alone failed to record any anti-filarial effect.H2 O2 alone also failed to show any significant effect until a very high dose was used.However,in combination significant anti-filarial effect was noticed,which allowed even 44% reduction in the dose of H2 O2 .Any significant lipid peroxidation was not found.Vitamin C demonstrated 30 % inhibitory effect.Conclusion:DEC and H2 O2 combination be-ing able to educe synergistic anti-filarial effect and inhibition of the same by vitamin C hinted towards covert oxidative component in the mechanism of DEC.Further implication of non-significant lipid peroxidation was addressed in the perspective of subtle oxidative nexus that seems to be operative in observed anti-filarial effect. Exploration of such rationale might lead to novel drug development.

  18. A Thematic Review of Interactive Whiteboard Use in Science Education: Rationales, Purposes, Methods and General Knowledge

    Ormanci, Ummuhan; Cepni, Salih; Deveci, Isa; Aydin, Ozhan

    2015-10-01

    In Turkey and many other countries, the importance of the interactive whiteboard (IWB) is increasing, and as a result, projects and studies are being conducted regarding the use of the IWB in classrooms. Accordingly, in these countries, many issues are being researched, such as the IWB's contribution to the education process, its use in classroom settings and problems that occur when using the IWB. In this context, the research and analysis of studies regarding the use of the IWB have important implications for educators, researchers and teachers. This study aims to review and analyze studies conducted regarding the use of the IWB in the field of science. Accordingly, as a thematic review of the research was deemed appropriate, extant articles available in the literature were analyzed using a matrix that consisted of general features (type of journal, year and demographic properties) and content features (rationales, aims, research methods, samples, data collections, results and suggestions). According to the findings, it was concluded that the studies regarding the use of IWBs were conducted due to deficiencies in the current literature. However, there are rare studies in which the reasons for the research were associated with the nature of science education. There were also studies that focused on the effects of the IWB on student academic success and learning outcomes. Within this context, it is evident that there is a need for further research concerning the use of IWBs in science education and for studies regarding the effect of IWBs on students' skills.

  19. China’s electric vehicle subsidy scheme: Rationale and impacts

    To promote the market penetration of electric vehicles (EV), China launched the Electric Vehicle Subsidy Scheme (EVSS) in Jan 2009, followed by an update in Sep 2013, which we named phase I and phase II EVSS, respectively. In this paper, we presented the rationale of China’s two-phase EVSS and estimated their impacts on EV market penetration, with a focus on the ownership cost analysis of battery electric passenger vehicles (BEPV). Based on the ownership cost comparison of five defining BEPV models and their counterpart conventional passenger vehicle (CPV) models, we concluded that in the short term, especially before 2015, China’s EVSS is very necessary for BEPVs to be cost competitive compared with CPVs. The transition from phase I to phase II EVSS will generally reduce subsidy intensity, thus resulting in temporary rise of BEPV ownership cost. However, with the decrease of BEPV manufacturing cost, the ownership cost of BEPV is projected to decrease despite of the phase-out mechanism under phase II EVSS. In the mid term of around 2015–2020, BEPV could become less or not reliant on subsidy to maintain cost competitiveness. However, given the performance disadvantages of BEPV, especially the limited electric range, China’s current EVSS is not sufficient for the BEPV market to take off. Technology improvement associated with battery cost reduction has to play an essential role in starting up China’s BEPV market. - Highlights: • China’s phase I and phase II electric vehicle subsidy schemes were reviewed. • Major electric vehicle models in China’s vehicle market were reviewed. • The ownership costs of five defining electric passenger vehicle models were compared. • Policies to promote electric vehicle deployment in China were discussed

  20. Rationale for using Peltophorum africanum (Fabaceae extracts in veterinary medicine

    S.E. Bizimenyera

    2005-06-01

    . aureus and 0.16 mg/mℓ for P. aeruginosa. There is therefore a rationale for the traditional use of root and bark of P. africanum in treating bacterial infection related diseases.

  1. Rationale and design of the RIACT–study: a multi-center placebo controlled double blind study to test the efficacy of RItuximab in Acute Cellular tubulointerstitial rejection with B-cell infiltrates in renal Transplant patients: study protocol for a randomized controlled trial

    2012-01-01

    Background Acute kidney allograft rejection is a major cause for declining graft function and has a negative impact on the long-term graft survival. The majority (90%) of acute rejections are T-cell mediated and, therefore, the anti-rejection therapy targets T-cell-mediated mechanisms of the rejection process. However, there is increasing evidence that intragraft B-cells are also important in the T-cell-mediated rejections. First, a significant proportion of patients with acute T-cell-mediated rejection have B-cells present in the infiltrates. Second, the outcome of these patients is inferior, which has been related to an inferior response to the conventional anti-rejection therapy. Third, treatment of these patients with an anti-CD20 antibody (rituximab) improves the allograft outcome as reported in single case observations and in one small study. Despite the promise of these observations, solid evidence is required before incorporating this treatment option into a general treatment recommendation. Methods/Design The RIACT study is designed as a randomized, double-blind, placebo-controlled, parallel group multicenter Phase III study. The study examines whether rituximab, in addition to the standard treatment with steroid-boli, leads to an improved one-year kidney allograft function, compared to the standard treatment alone in patients with acute T-cell mediated tubulointerstitial rejection and significant B-cell infiltrates in their biopsies. A total of 180 patients will be recruited. Discussion It is important to clarify the relevance of anti-B cell targeting in T-cell mediated rejection and answer the question whether this novel concept should be incorporated in the conventional anti-rejection therapy. Trial registration Clinical trials gov. number: NCT01117662 PMID:23101480

  2. Rationale and design of the RIACT–study: a multi-center placebo controlled double blind study to test the efficacy of RItuximab in Acute Cellular tubulointerstitial rejection with B-cell infiltrates in renal Transplant patients: study protocol for a randomized controlled trial

    Schiffer Lena

    2012-10-01

    Full Text Available Abstract Background Acute kidney allograft rejection is a major cause for declining graft function and has a negative impact on the long-term graft survival. The majority (90% of acute rejections are T-cell mediated and, therefore, the anti-rejection therapy targets T-cell-mediated mechanisms of the rejection process. However, there is increasing evidence that intragraft B-cells are also important in the T-cell-mediated rejections. First, a significant proportion of patients with acute T-cell-mediated rejection have B-cells present in the infiltrates. Second, the outcome of these patients is inferior, which has been related to an inferior response to the conventional anti-rejection therapy. Third, treatment of these patients with an anti-CD20 antibody (rituximab improves the allograft outcome as reported in single case observations and in one small study. Despite the promise of these observations, solid evidence is required before incorporating this treatment option into a general treatment recommendation. Methods/Design The RIACT study is designed as a randomized, double-blind, placebo-controlled, parallel group multicenter Phase III study. The study examines whether rituximab, in addition to the standard treatment with steroid-boli, leads to an improved one-year kidney allograft function, compared to the standard treatment alone in patients with acute T-cell mediated tubulointerstitial rejection and significant B-cell infiltrates in their biopsies. A total of 180 patients will be recruited. Discussion It is important to clarify the relevance of anti-B cell targeting in T-cell mediated rejection and answer the question whether this novel concept should be incorporated in the conventional anti-rejection therapy. Trial registration Clinical trials gov. number: NCT01117662

  3. The Rationale of Crisis Management – On the Handling of Coincidence in Economic Situation

    Peter Bendixen

    2010-07-01

    Full Text Available The subject of this essay is too complex a problem as to cover all details in depth and, thus, draws its attention only to core aspects of the handling of coincidence leaving out sophisticated studies and analytic findings as well as detailed reference to economic literature though there is not very much. On the other hand, for a lot of actual as well as general reasons, the subject is too important a matter as to ignore the serious methodological problems of crisis management, which are rooted in some politically still active bias hidden in orthodox neo-classical economics (Stiglitz 2010. If crisis management continues to follow traditional rationales, it will fail realizing the increasing dynamic of crises within the globalising economies of the world. No existing economy can be considered as an isolated system of its own embedded in a stable composition of societal surroundings. Obviously, many a critical situation has its origin in the sphere of civilization, of political discrepancies, and of administrative inflexibilities. On the other hand, any grave amplitude of markets would touch the entire social surrounding. The belief in the markets’ strength of self-regulation is a dangerous construction of orthodox economics (Bendixen 2009b, 2010. The view on crises suggested here is that of a holistic approach to understand a critical situation. Any interpretation of a situation includes empirical dates and figures based on analytic research, but solving a problem is not an act of logical derivation from findings, as if a solution can be excavated in the mud of reality by empirical studies only. Empirical figures report events of the past; the future does not reveal any empiricism. This would be a contradiction in itself. The end of a crisis as well as the search for solutions to fight the problems revealed is unavoidably a view into the future. Therefore, the rationale of crisis management cannot be made of pure empiricism but should include a

  4. The place of the clock in pediatric advice: rationales, cultural themes, and impediments to breastfeeding.

    Millard, A V

    1990-01-01

    This analysis treats the U.S. medical literature as evidence concerning the formal system of knowledge in allopathic medicine. An examination of pediatric advice on breastfeeding reveals the logic of medical reasoning, the use of scientific rationales, and the intrusion of specific cultural themes. The corpus of data includes works of 18 authors published in 36 volumes from 1897 to 1987, 27 volumes being editions of two major pediatric textbooks. All sources advocate breastfeeding but the detailed advice on how to carry out the process actually tends to undermine it. Moreover, the clock has provided the main frame of reference, creating regimentation reminiscent of factory work, segmenting breastfeeding into a series of steps, and emphasizing efficiency in time and motion. Feeding schedules were advocated in former decades as a matter of discipline for the infant, but nowadays they are viewed as biologically innate to normal infants and to breast milk production. The literature manifests responses over the century to behavioral, biochemical and physiological studies; however, except possibly for one textbook, no thorough rethinking has occurred. Sources of the 1980s continue to focus on the tempo of feeding as a major concern. Cultural themes besides the factory model of breastfeeding include the extension of professional advice to family matters, the subordination of lay women to professional expertise, mistrust of women's bodily signals including the let-down reflex in determining the timing of feedings, mistrust of signals from infants as well, and a professional ideal of flexible advice coupled with rigid limits concerning schedules. The literature interweaves the cultural themes with rationales based on physiological studies in support of specific regimens in breastfeeding, and the relegation of control in breastfeeding to medical experts denies the validity of mutual bodily and emotional responses within the mother-infant dyad. Pediatric authorities thus

  5. Familial orientations and the rationales for childbearing behaviour

    Beaujot, Roderic

    2006-01-01

    Full Text Available EnglishUsing a local qualitative sample from Ontario, we explore the rationales forchildbearing behaviour across contrasting familial orientations. There are considerable similaritiesamong respondents with traditional and modernfamilial orientations in terms of the reasons for having children and the costsand values of children. Nonetheless, persons with modern orientations are morelikely to give individual related reasons for having children, and to see the valueof children in terms of personal needs and desires. The largest difference relatesto the ideal timing of childbearing, as persons with modern orientations are morelikely to prefer childbearing in the late 20s or early 30s. While the rationalesoffered by respondents indicate a culture that is supportive of childbearing, andindividuals with more modern orientations have views similar to those withtraditional orientations on ideal family size and on the value and cost of children,they will probably have fewer children given their more individualisticorientation to childbearing and the conviction that later childbearing is better.FrenchEn nous servant d’un échantillonnage qualitatif local provenant de l’Ontario,nous explorons les raisons derrières les comportements procréatifs dans desfoyers d’orientations familiales différentes. Il existe d’importantes similaritésentre les répondants d’orientation familiale traditionnelle et ceux d’orientationfamiliale moderne quant aux raison d’avoir des enfants et au sujet de la valeuraccordée aux enfants et des frais qu’ils entraînent. Cependant, les personnes auxorientations modernes ont une plus forte tendance à citer des raisonspersonnelles pour avoir des enfants et la valeur qu’ils leurs accordent est citéecomme un besoin et un désir personnel. La plus grande différence se trouve auniveau du choix du moment idéal pour la procréation, avec une tendance parmiles personnes d’orientation familiale moderne de pr

  6. 心房颤动发生机制及干预方法学研究:基本原理和设计方案%Study of mechanism of atrial fibrillation and comparison of ablation and pharmacological therapy (SMAF-CAPT) :rationale and design

    黄从新; 张澍; 马长生; 江洪; 黄鹤; 吴钢; 李红良; 唐艳红; 杨波

    2014-01-01

    Background Mechanism of atrial fibrillation (AF) is still unclear,its related genes and upstream regulatory mechanisms should be studied.The major treatments of AF include pharmacological therapy (PT) and catheter ablation (CA),and it has been proved that CA is more suitable than PT,but our own clinical data remain unknown.The purpose of SMAF-CAPT is to explore the mechanism of AF and its suitable treatments strategy.The study consists of two parts:①study of mechanism of atrial fibrillation (SMAF),②comparison of ablation and pharmacological therapy (CAPA).Rationale ①SMAF study:Cardiac electrophysiology can be upstream regulated in many aspects and links,such as neurotransmitters,protein kinases,G proteins,the relation between them and arrhythmia has been increasingly taken seriously.Our previous studies have demonstrated that regulator of G protein signaling 5 (RGS5) is closely related by cardiac hypertrophy and arrhythmias.Furthermore,it also finds that micro RNA (miRNA) is closely associated with arrhythmia,which provides a new direction for upstream regulation of arrhythmia.In recent years,it has been proved patients with refractory hypertension can get benefits from renal sympathetic denervation (RDN),which can change the autonomic nervous system and thus may affect the occurrence and maintenance of AF.However,the exact effect and mechanism are unclear,and the influence to RDN on atrium matrix remodeling also needs attention.Screen AF-related genes by genetic engineering technique,and then establish animals models of specific genes modification,SMAF aims to explore the feasibility and targets of upstream regulation to AF.And to study the impact and mechanisms of RDN on trigger and maintenance of AF.②CAPA Study:Pharmacological treatment (PT) can partly maintain the sinus rhythm,or improve the symptoms of patients with chronic heart failure,but its long-term effects seem poor.The strategy of ventricular rate control has no significant benefit on the

  7. Alloplastic temporomandibular joint replacement: rationale for the use of custom devices.

    Mercuri, L G

    2012-09-01

    The essential life functions of mastication, speech, airway support and deglutition are supported by temporomandibular joint (TMJ) function and form. Over a lifetime, this puts the TMJ complex under more cyclical loading and unloading than any other joint. Therefore, to provide long-term effective outcomes, the TMJ total joint replacement (TJR) device selected must be capable of managing the anatomical, functional and aesthetic discrepancies that dictated its use. The primary goal of TMJ TJR is the restoration of mandibular function and form. Outcomes data confirm that any pain relief attained must be considered of only secondary benefit. Despite persistent but reduced chronic pain, increased mandibular function and form improvement have been reported, resulting in quality of life improvement for 85% of custom TMJ TJR patients studied long-term. Based on the literature and the accepted orthopaedic criteria for the development and utilisation of successful TJR devices, this paper presents a rationale for the use of custom TMJ TJR devices as a 'fitting' management option for end-stage TMJ disorders. PMID:22771166

  8. The rationale and potential for the reduction of oral malodour using Streptococcus salivarius probiotics.

    Burton, J P; Chilcott, C N; Tagg, J R

    2005-01-01

    The primary treatment for oral malodour is the reduction of bacterial populations, especially those present on the tongue, by use of a variety of antimicrobial agents or mechanical devices. However, shortly after treatment the problematic bacteria quickly repopulate the tongue and the malodour returns. In our studies, we have used a broadly-active antimicrobial (chlorhexidine) to effect temporary depletion of the oral microbiota and then have attempted to repopulate the tongue surface with Streptococcus salivarius K12, a benign commensal probiotic. The objective of this is to prevent re-establishment of non-desirable bacterial populations and thus help limit the re-occurrence of oral malodour over a prolonged period. In this paper, we discuss why contemporary probiotics are inadequate for treatment of oral malodour and examine the rationale for selection of particular bacterial species for future use in the treatment of this condition. In our preliminary trials of the use of a chlorhexidine rinse followed by strain K12 lozenges, the majority (8/13) of subjects with confirmed halitosis maintained reduced breath levels of volatile sulphur compounds for at least 2 weeks. We conclude that probiotic bacterial strains originally sourced from the indigenous oral microbiotas of healthy humans may have potential application as adjuncts for the prevention and treatment of halitosis. PMID:15752094

  9. National G6PD neonatal screening program in Gaza Strip of Palestine: rationale, challenges and recommendations.

    Sirdah, M M; Al-Kahlout, M S; Reading, N S

    2016-09-01

    Congenital genetic disorders affecting neonates or young children can have serious clinical consequences if undiagnosed and left untreated. Early detection and an accurate diagnosis are, therefore, of major importance for preventing negative patient outcomes. Even though the occurrence of each specific metabolic disorder may be rare, their collective impact of preventable complications may be of considerable importance to the public health. Our previous studies showed that glucose-6-phosphate dehydrogenase (G6PD) deficiency is a problem of public health importance that has been shown to be a predominant cause of acute hemolytic anemia requiring hospitalization in Palestinian young children in Gaza Strip. Intriguingly, the majority of these children had one of the three variants, Mediterranean(c.) (563T) , African G6PD A-(c.) (202A) (/c.) (376G) and heretofore unrecognized as a common G6PD-deficient variant G6PD Cairo(c.) (404C) . The high prevalence of G6PD deficiency, as well as dietary factors in the region that precipitate anemia, argues for a need to protect the Palestinian children from a treatable and manageable genetic and metabolic disorder. This work reviews and discusses rationales and challenges of G6PD screening program in Gaza Strip. We advocate adopting a national neonatal G6PD screening program in Gaza Strip to identify children at risk and promote wellness and health for Palestine. PMID:27064064

  10. Constructing a Theory- and Evidence-Based Treatment Rationale for Complex eHealth Interventions: Development of an Online Alcohol Intervention Using an Intervention Mapping Approach

    Brendryen, Håvar; Johansen, Ayna; Nesvåg, Sverre; Kok, Gerjo; Duckert, Fanny

    2013-01-01

    Background Due to limited reporting of intervention rationale, little is known about what distinguishes a good intervention from a poor one. To support improved design, there is a need for comprehensive reports on novel and complex theory-based interventions. Specifically, the emerging trend of just-in-time tailoring of content in response to change in target behavior or emotional state is promising. Objective The objective of this study was to give a systematic and comprehensive description ...

  11. The Rationale, Design, and Initial Efficacy of SystemCHANGE™ -HIV: A Systems-Based Intervention to Improve Physical Activity in People Living with HIV

    Webel, Allison R; Moore, Shirley M.; Hanson, Jan E.; Salata, Robert A.

    2013-01-01

    The purpose of this paper was to describe SystemCHANGE™-HIV, a novel self-management intervention for people living with HIV (PLWH) and provide evidence of its initial efficacy to improve physical activity. The rationale and design of the SystemCHANGE™-HIV intervention were reviewed. Intervention detail, including its historical use, learning exercises and content, were provided. Forty PLWH participated in this pilot study, using a randomized clinical trial design. Intervention participants i...

  12. The Harvard/Brown Anxiety Research Project – Phase II (HARP-II): Rationale, methods, and features of the sample at intake

    Weisberg, Risa B.; Beard, Courtney; Dyck, Ingrid; Keller, Martin B.

    2012-01-01

    We describe the rationale, method, and intake demographic and clinical findings of the Harvard/Brown Anxiety Research Project-Phase II (HARP-II). HARP-II is the first prospective, observational, longitudinal study to describe the characteristics and course of anxiety in African American, Latino, and Non-Latino White individuals. Participants met criteria for at least one of the following disorders: Generalized Anxiety Disorder, Social Phobia, Panic Disorder with or without Agoraphobia, Agorap...

  13. Canadian nuclear power principles for beyond design basis events - supporting rationale

    The development of the following principles and their rationale began during a special Chief Nuclear Engineers forum held on March 25th, 2013 in Toronto. These principles are intended to provide guidance to the Canadian Nuclear Power Industry in developing responses to the lessons learned from the Fukushima event of March 2011. These principles were accepted and signed off by the Chief Nuclear Officers of each of the three utilities in August 2013 and were presented to the CNSC at a public hearing on August 21, 2013. This document provides the underlying rationale for the principles. (author)

  14. Influences of BRAF Inhibitors on the Immune Microenvironment and the Rationale for Combined Molecular and Immune Targeted Therapy.

    Reddy, Sangeetha M; Reuben, Alexandre; Wargo, Jennifer A

    2016-07-01

    The identification of key driver mutations in melanoma has led to the development of targeted therapies aimed at BRAF and MEK, but responses are often limited in duration. There is growing evidence that MAPK pathway activation impairs antitumor immunity and that targeting this pathway may enhance responses to immunotherapies. There is also evidence that immune mechanisms of resistance to targeted therapy exist, providing the rationale for combining targeted therapy with immunotherapy. Preclinical studies have demonstrated synergy in combining these strategies, and combination clinical trials are ongoing. It is, however, becoming clear that additional translational studies are needed to better understand toxicity, proper timing, and sequence of therapy, as well as the utility of multidrug regimens and effects of other targeted agents on antitumor immunity. Insights gained through translational research in preclinical models and clinical studies will provide mechanistic insight into therapeutic response and resistance and help devise rational strategies to enhance therapeutic responses. PMID:27215436

  15. Development of a Publicly Available, Comprehensive Database of Fiber and Health Outcomes: Rationale and Methods.

    Kara A Livingston

    Full Text Available Dietary fiber is a broad category of compounds historically defined as partially or completely indigestible plant-based carbohydrates and lignin with, more recently, the additional criteria that fibers incorporated into foods as additives should demonstrate functional human health outcomes to receive a fiber classification. Thousands of research studies have been published examining fibers and health outcomes.(1 Develop a database listing studies testing fiber and physiological health outcomes identified by experts at the Ninth Vahouny Conference; (2 Use evidence mapping methodology to summarize this body of literature. This paper summarizes the rationale, methodology, and resulting database. The database will help both scientists and policy-makers to evaluate evidence linking specific fibers with physiological health outcomes, and identify missing information.To build this database, we conducted a systematic literature search for human intervention studies published in English from 1946 to May 2015. Our search strategy included a broad definition of fiber search terms, as well as search terms for nine physiological health outcomes identified at the Ninth Vahouny Fiber Symposium. Abstracts were screened using a priori defined eligibility criteria and a low threshold for inclusion to minimize the likelihood of rejecting articles of interest. Publications then were reviewed in full text, applying additional a priori defined exclusion criteria. The database was built and published on the Systematic Review Data Repository (SRDR™, a web-based, publicly available application.A fiber database was created. This resource will reduce the unnecessary replication of effort in conducting systematic reviews by serving as both a central database archiving PICO (population, intervention, comparator, outcome data on published studies and as a searchable tool through which this data can be extracted and updated.

  16. The SCOUT-O3 Darwin Aircraft Campaign: rationale and meteorology

    D. Brunner

    2009-01-01

    Full Text Available An aircraft measurement campaign involving the Russian high-altitude aircraft M55 Geophysica and the German DLR Falcon was conducted in Darwin, Australia in November and December 2005 as part of the European integrated project SCOUT-O3. The overall objectives of the campaign were to study the transport of trace gases through the tropical tropopause layer (TTL, mechanisms of dehydration close to the tropopause, and the role of deep convection in these processes. In this paper a detailed roadmap of the campaign is presented, including rationales for each flight, and an analysis of the local and large-scale meteorological context in which they were embedded. The campaign took place during the pre-monsoon season which is characterized by a pronounced diurnal evolution of deep convection including a mesoscale system over the Tiwi Islands north of Darwin known as "Hector". This allowed studying in detail the role of deep convection in structuring the tropical tropopause region, in situ sampling convective overshoots above storm anvils, and probing the structure of anvils and cirrus clouds by Lidar and a suite of in situ instruments onboard the two aircraft. The large-scale flow during the first half of the campaign was such that local flights, away from convection, sampled air masses downstream of the "cold trap" region over Indonesia. Abundant cirrus clouds enabled the study of active dehydration, in particular during two TTL survey flights. The campaign period also encompassed a Rossby wave breaking event transporting stratospheric air to the tropical middle troposphere and an equatorial Kelvin wave modulating tropopause temperatures and hence the conditions for dehydration.

  17. The SCOUT-O3 Darwin Aircraft Campaign: rationale and meteorology

    D. Brunner

    2008-09-01

    Full Text Available An aircraft measurement campaign involving the Russian high-altitude aircraft M55 Geophysica and the German DLR Falcon was conducted in Darwin, Australia in November and December 2005 as part of the European integrated project SCOUT-O3. The overall objectives of the campaign were to study the transport of trace gases through the tropical tropopause layer (TTL, mechanisms of dehydration close to the tropopause, and the role of deep convection in these processes. In this paper a detailed roadmap of the campaign is presented, including rationales for each flight, and an analysis of the local and large-scale meteorological context in which they were embedded. The campaign took place during the pre-monsoon season which is characterized by a pronounced diurnal evolution of deep convection including a mesoscale system over the Tiwi Islands north of Darwin known as "Hector". This allowed studying in detail the role of deep convection in structuring the tropical tropopause region, in situ sampling convective overshoots above storm anvils, and probing the structure of anvils and cirrus clouds by Lidar and a suite of in situ instruments onboard the two aircraft. The large-scale flow during the first half of the campaign was such that local flights, away from convection, sampled air masses downstream of the "cold trap" region over Indonesia. Abundant cirrus clouds enabled the study of active dehydration, in particular during two TTL survey flights. The campaign period also encompassed a Rossby wave breaking event transporting stratospheric air to the tropical middle troposphere and an equatorial Kelvin wave modulating tropopause temperatures and hence the conditions for dehydration.

  18. On the rationale of resilience in the domain of safety: A literature review

    Resilience is becoming a prevalent agenda in safety research and organisational practice. In this study we examine how the peer-reviewed safety science literature (a) formulates the rationale behind the study of resilience; (b) constructs resilience as a scientific object; and (c) constructs and locates the resilient subject. The results suggest that resilience engineering scholars typically motivate the need for their studies by referring to the inherent complexities of modern socio-technical systems; complexities that make these systems inherently risky. The object of resilience then becomes the capacity to adapt to such emerging risks in order to guarantee the success of the inherently risky system. In the material reviewed, the subject of resilience is typically the individual, either at the sharp end or at higher managerial levels. The individual is called-upon to adapt in the face of risk to secure the continuous performance of the system. Based on the results from how resilience has been introduced in safety sciences we raise three ethical questions for the field to address: (1) should resilience be seen as people thriving despite of, or because of, risk?; (2) should resilience theory form a basis for moral judgement?; and finally (3) how much should resilience be approached as a trait of the individual? - Highlights: • The article reviews the object of resilience in the safety science literature. • The literature offers a clear link between the notions of complexity and danger. • Danger is managed through adaptive capacity (resilience), typically at the sharp end. • The ethical implications of accepting danger at the sharp end need to be debated

  19. Of Private, Common, and Public Property and the Rationale for Total Privatization

    Hans-Hermann Hoppe

    2011-02-01

    Full Text Available In this paper, first, I want to clarify the nature and function of private property. Second, I want to clarify the distinction between “common” goods and property and “public” goods and property, and explain the construction error inherent in the institution of public goods and property. Third, I want to explain the rationale and principle of privatization.

  20. Getting More Bang for the Buck: Determining the Economic Rationale of Vocational Education. A VES Monograph.

    McElhinney, Kerry R.; Pershing, James A.

    Vocational education in the United States has come under increased scrutiny, and its proponents need the tools to convince the critics of its merits. Many economic conditions have a strong impact on vocational education, and understanding of economics is important in offering a rationale of vocational education. In a time of shrinking revenues,…

  1. Sequence, Program Words, and Sequence Rationale for the 1971 Revised First-Grade Spelling Program.

    Berdiansky, Betty

    Pupils participating in the 1971-1972 tryout of the Southwest Regional Laboratory (SWRL) First Grade Spelling Program were taught to combine consonants and consonant clusters with word elements to form program words. This paper presents the sequence of instruction for these elements and the rationale used in deriving this sequence. In addition, it…

  2. Astigmatism treatment during phacoemulsification: a review of current surgical strategies and their rationale

    Giuliano de Oliveira Freitas; Joel Edmur Boteon; Mario José Carvalho; Rogerio Melo Costa Pinto

    2013-01-01

    Preexisting corneal astigmatism, present at the time of cataract surgery, is reviewed in detail throughout this article on its most important aspects such as occurrence rates, clinical relevance and current treatment options. Special emphasis is given to the latter aspect. Each method's rationale, advantage and limitation ishigh lightened. Comparisons between treatment options, whenever possible, are also provided.

  3. Astigmatism treatment during phacoemulsification: a review of current surgical strategies and their rationale

    Giuliano de Oliveira Freitas

    2013-12-01

    Full Text Available Preexisting corneal astigmatism, present at the time of cataract surgery, is reviewed in detail throughout this article on its most important aspects such as occurrence rates, clinical relevance and current treatment options. Special emphasis is given to the latter aspect. Each method's rationale, advantage and limitation ishigh lightened. Comparisons between treatment options, whenever possible, are also provided.

  4. Five Big, Big Five Issues : Rationale, Content, Structure, Status, and Crosscultural Assessment

    De Raad, Boele

    1998-01-01

    This article discusses the rationale, content, structure, status, and crosscultural assessment of the Big Five trait factors, focusing on topics of dispute and misunderstanding. Taxonomic restrictions of the original Big Five forerunner, the "Norman Five," are discussed, and criticisms regarding the

  5. Establishing Assessment Scales Using a Novel Disciplinary Rationale for Scientific Reasoning

    Kind, Per Morten

    2013-01-01

    The article argues that science assessment should change from an item-driven to a construct-driven practice and pay more attention to disciplinary scientific reasoning. It investigates assessment scales developed from a novel theoretical rationale, describing scientific reasoning as three fundamental practices (hypothesizing, experimenting, and…

  6. Combating 'inflammaging' through a Mediterranean whole diet approach: the NU-AGE project rationale

    Santoro, A.; Pini, E.; Scurti, M.; Palmas, G.; Berendsen, A.; Brzozowska, A.M.; The NU-AGE Consortium, A.; Groot, de C.P.G.M.; Feskens, E.J.M.; Fairweather-Tait, S.; Salvioli, S.; Capri, M.

    2013-01-01

    The development of a chronic, low grade, inflammatory status named "inflammaging" is a major characteristic of aging which plays a critical role in the pathogenesis of age-related diseases. The NU-AGE rationale is that a one year Mediterranean whole diet (considered by UNESCO a heritage of humanity)

  7. From "Refuge" to "Polis": Shifting the Rationale for Religiosity in Schools

    Dippo, Don

    2010-01-01

    This article responds to Bruce Collet's article "From Refuge to Polis: Shifting the Rationale for Religiosity in Schools." In this rejoinder my intention is to shift the discussion from school-as-refuge to school-as-polis and to ask whether the integration interests of recent immigrants and refugees might not be better served by a more inclusive…

  8. Physics Education Research in the United States: A Summary of Its Rationale and Main Findings.

    Gonzales-Espada, Wilson J.

    2003-01-01

    Recognizes how difficult it is for secondary and post-secondary students to make connections between physics and everyday phenomena, rationalize the use of a particular formula for a given problem, and go beyond algebraic substitutions to really make sense of physics in a meaningful way. Provides a rationale for physicists to become involved in…

  9. Rationale for Students Preparation and Entrepreneurship Education in the Face of Global Economic Crisis in Nigeria

    Onuma, Nwite

    2016-01-01

    The rationale for students preparation in job creation through entrepreneurship education was examined. Problems of unemployment among Nigerian university graduates and challenges to entrepreneurship in the face of global economic crisis were also highlighted. The persistent problem of unemployment among University graduates and its attendant…

  10. Coercion or Compulsion?: Rationales behind Informal Payments for Education in Azerbaijan

    Lepisto, Eric; Kazimzade, Elmina

    2009-01-01

    Although informal payments are necessary for education systems in many countries, they prohibit education accessibility and equity in Eastern Europe and neighboring states. Exploring the rationales and the relationships is a promising approach for understanding corruption in education and ensuring educational equity. In this article, rationales…

  11. Advanced water-cooled reactor technologies. Rationale, state of progress and outlook

    Eighty per cent of the world's power reactors are water cooled and moderated. Many improvements in their design and operation have been implemented since the first such reactor started commercial operation in 1957. This report addresses the safety, environmental and economic rationales for further improvements, as well as their relevance to currently operating water reactors

  12. Health promotion – The rationale and the obstacles in workplaces with different employment and financial soundness

    Krzysztof Puchalski

    2013-12-01

    Full Text Available Background: This paper presents the prevalence of health promotion in workplaces in Poland. It characterises the undertaken actions, their rationale and perceived obstacles. It analyses the diversity of these phenomena in the companies of different financial soundness and level of employment. Material and Methods: The study was conducted with the use of Computer Assisted Telephone Interview in 2010 on the representative national sample of 1002 workplaces hiring more than 50 employees. The data was compared with the results of the survey conducted in 2006, with the use of a Paper and Pencil interview on 611 similar companies. Results: Both studies have shown that 40% of the companies are concerned about their employees' health to a greater extent than they are obliged to by the law. At the same time, more than 80% of the companies have been introducing various modifications and health-oriented actions without definite health intentions. Most companies improve their physical working environment, organise/sponsor medical services, sports activities and try to reduce stress and smoking. Managers have increased their awareness of business benefits received from health promotion. They have displayed more personal involvement in health promotion implementation. The most often mentioned obstacles have included limited financial resources and little interest of employees regarding health issues. Conclusions: The larger and wealthier the company is, the more often health promotion in the company is performed. Such a company is more convinced about an increase in its activities and has more reasons to care about health. Unequal access to health promotion of workers in different companies may contribute to an increase in health inequalities in the working population. Med Pr 2013;64(6:743–754

  13. Combining GLP-1 receptor agonists with insulin: therapeutic rationales and clinical findings.

    Holst, J J; Vilsbøll, T

    2013-01-01

    Due to the increasing prevalence of type 2 diabetes mellitus (T2DM), the emergent trend towards diagnosis in younger patients and the progressive nature of this disease, many more patients than before now require insulin to maintain glycaemic control. However, there is a degree of inertia among physicians and patients regarding the initiation and intensification of insulin therapy, in part due to concerns about the associated weight gain and increased risk of hypoglycaemia. Glucagon-like peptide-1 receptor agonists (GLP-1RAs) increase insulin release and suppress glucagon secretion in a glucose-dependent manner, thus conferring glycaemic control with a low incidence of hypoglycaemia. GLP-1RAs also promote weight loss, and have beneficial effects on markers of β cell function, lipid levels, blood pressure and cardiovascular risk markers. However, the durability of their effectiveness is unknown and, compared with insulin, the antihyperglycaemic efficacy of GLP-1RAs is limited. The combination of a GLP-1RA and insulin might thus be highly effective for optimal glucose control, ameliorating the adverse effects typically associated with insulin. Data from clinical studies support the therapeutic potential of GLP-1RA-insulin combination therapy, typically showing beneficial effects on glycaemic control and body weight, with a low incidence of hypoglycaemia and, in established insulin therapy, facilitating reductions in insulin dose. In this review, the physiological and pharmacological rationale for using GLP-1RA and insulin therapies in combination is discussed, and data from clinical studies that have assessed the efficacy and safety of this treatment strategy are outlined. PMID:22646532

  14. Environmental benefits and economic rationale of expanding the Italian natural gas private car fleet

    There are several concerns which bring to consider natural gas as a viable alternative to liquid fuels in transport. First, natural gas allows the curbing of global pollution in this steadily growing industry. Indeed, decoupling greenhouse gas emissions from transport growth has become a major issue in tackling climate change. Second, a more extensive use of natural gas would relieve city air quality, which is presently at levels harmful of human health. Nonetheless, this is just one side of the coin. The other side entails building a refuelling station network, and this carries financial requirements. The financing fraction holds a pivotal role in deciding whether natural gas for automotive purposes is an efficient solution. The final aim of this work is, therefore, to compare the natural gas advantages, stemming from avoided global and local emission, with the economic rationale of engaging in supplementary model network investments. A system dynamics model underlies this study's economic reasoning and is taken as reference for quantitative assertions. The model, named CH4CleanerAir, contains data referring to two scenarios: a Business As Usual Scenario and an Expansion Scenario. Simulation runs in Expansion Scenario serve to understand how gaseous pollution diminishes and network investments rise when the natural gas-fuelled fleet, as share of the total fleet, increases. Are new infrastructures needs compatible with existing refuelling facilities? What is the extent by which the natural gas-fuelled fleet can actually reduce global and local emission? The scenarios' gap analysis lead to the work's final considerations. The sounder reductions of gaseous pollutants in the last years of the considered time lag make the overall assessment lean towards a positive evaluation of natural gas employment in this industry. The beneficial effects of increasing the natural gas-fuel-led fleet take some time to unfold, but they eventually prevail. This study shows how natural

  15. The NordiNet® International Outcome Study and NovoNet® ANSWER Program®: rationale, design, and methodology of two international pharmacoepidemiological registry-based studies monitoring long-term clinical and safety outcomes of growth hormone therapy (Norditropin®

    Höybye C

    2013-04-01

    Full Text Available Charlotte Höybye,1 Lars Sävendahl,2 Henrik Thybo Christesen,3 Peter Lee,4 Birgitte Tønnes Pedersen,5 Michael Schlumpf,6 John Germak,7 Judith Ross8 1Department of Molecular Medicine and Surgery, Karolinska Institute and Department of Endocrinology, Metabolism and Diabetes, 2Department of Women’s and Children’s Health, Karolinska Institute and Division of Pediatrics, Karolinska University Hospital, Stockholm, Sweden; 3Hans Christian Andersen Children’s Hospital, Odense University Hospital, Odense, Denmark; 4Department of Pediatrics, Penn State College of Medicine, Hershey, PA, USA; 5Global Development, Novo Nordisk A/S, Søborg, Denmark; 6Global Medical Affairs Biopharm, Novo Nordisk Health Care AG, Zurich, Switzerland; 7Clinical Development and Medical Affairs, Novo Nordisk Inc, Princeton, NJ, USA; 8Department of Pediatrics, Thomas Jefferson University, Philadelphia, PA, USA Objective: Randomized controlled trials have shown that growth hormone (GH therapy has effects on growth, metabolism, and body composition. GH therapy is prescribed for children with growth failure and adults with GH deficiency. Carefully conducted observational study of GH treatment affords the opportunity to assess long-term treatment outcomes and the clinical factors and variables affecting those outcomes, in patients receiving GH therapy in routine clinical practice. Design: The NordiNet® International Outcome Study (IOS and the American Norditropin® Studies: Web Enabled Research (ANSWER Program® are two complementary, non-interventional, observational studies that adhere to current guidelines for pharmacoepidemiological data. Patients: The studies include pediatric and adult patients receiving Norditropin®, as prescribed by their physicians. Measurements: The studies gather long-term data on the safety and effectiveness of real-life treatment with the recombinant human GH, Norditropin®. We describe the origins, aims, objectives, and design methodology of

  16. CORonary Diet Intervention with Olive oil and cardiovascular PREVention study (the CORDIOPREV study): Rationale, methods, and baseline characteristics: A clinical trial comparing the efficacy of a Mediterranean diet rich in olive oil versus a low-fat diet on cardiovascular disease in coronary patients.

    Delgado-Lista, Javier; Perez-Martinez, Pablo; Garcia-Rios, Antonio; Alcala-Diaz, Juan F; Perez-Caballero, Ana I; Gomez-Delgado, Francisco; Fuentes, Francisco; Quintana-Navarro, Gracia; Lopez-Segura, Fernando; Ortiz-Morales, Ana M; Delgado-Casado, Nieves; Yubero-Serrano, Elena M; Camargo, Antonio; Marin, Carmen; Rodriguez-Cantalejo, Fernando; Gomez-Luna, Purificacion; Ordovas, Jose M; Lopez-Miranda, Jose; Perez-Jimenez, Francisco

    2016-07-01

    Coronary heart disease (CHD) represents a major global health burden. However, despite the well-known influence that dietary habits exert over the progression of this disease, there are no well-established and scientifically sound dietary approaches to prevent the onset of clinical outcomes in secondary prevention. The objective of the CORonary Diet Intervention with Olive oil and cardiovascular PREVention study (CORDIOPREV study, clinical trials number NCT00924937) is to compare the ability of a Mediterranean diet rich in virgin olive oil versus a low-fat diet to influence the composite incidence of cardiovascular events after 7 years in subjects with documented CHD at baseline. For this purpose, we enrolled 1,002 coronary patients from Spain. Baseline assessment (2009-2012) included detailed interviews and measurements to assess dietary, social, and biological variables. Results of baseline characteristics: The CORDIOPREV study in Spain describes a population with a high body mass index (37.2% overweight and 56.3% obesity) and with a median of low-density lipoprotein cholesterol of 88.5 mg/dL (70.6% of the patients having study, which will test for the first time the efficacy of a Mediterranean diet rich in extra virgin olive oil as compared with a low-fat diet on the incidence of CHD recurrence in a long-term follow-up study. PMID:27297848

  17. A Content Assist based Approach for Providing Rationale of Method Change for Object Oriented Programming

    Amit S. Ami

    2015-01-01

    Full Text Available Software engineering requires modification of code during development and maintenance phase. During modification, a difficult task is to understand rationale of changed code. Present Integrated Development Environments (IDEs attempt to help this by providing features integrated with different types of repositories. However, these features still consume developer's time as he has to switch from editor to another window for this purpose. Moreover, these features focus on elements available in present version of code, thus increasing the difficulty of finding rationale of an element removed or modified earlier. Leveraging different sources for providing information through code completion menus has been shown to be valuable, even when compared to standalone counterparts offering similar functionalities in literature. Literature also shows that it is one of the most used features for consuming information within IDE. Based on that, we prepare an Eclipse plug-in and a framework that allows providing reason of code change, at method granularity, across versions through a new code completion menu in IDE. These allow a software engineer to gain insight about rationale of removed or modified methods which are otherwise not available in present version of code. Professional software engineers participated in our empirical evaluation process and we observed that more than 80% participants considered this to be a useful approach for saving time and effort to understand rationale of method change. Later, based on their feedback, the plug-in and framework is modified to incorporate chronological factors. We perform quasi experimental evaluation with professional software engineers. It is found that time required to find rationale of method change is reduced to at least half compared to usual amount of time required for all the software engineers who participated in the quantitative evaluation.

  18. Is there a rationale for short cardioplegia re-dosing intervals?

    Yves; D; Durandy

    2015-01-01

    While cardioplegia has been used on millions of patients during the last decades, the debate over the best technique is still going on. Cardioplegia is not only meant to provide a non-contracting heart and a field without blood, thus avoiding the risk of gas emboli, but also used for myocardial protection. Its electromechanical effect is easily confirmed through direct vision of the heart and continuous electrocardiogram monitoring, but there is no consensus on the best way to assess the quality of myocardial protection. The optimal approach is thus far from clear and the considerable amount of literature on the subject fails to provide a definite answer. Cardioplegia composition(crystalloid vs blood, with or without various substrate enhancement), temperature and site(s) of injection have been extensively researched. While less frequently studied, re-dosing interval is also an important factor. A common and intuitive idea is that shorter redosing intervals lead to improved myocardial protection. A vast majority of surgeons use re-dosing intervals of 20-30 min, or even less, during coronary artery bypass graft and multidose cardioplegia has been the "gold standard" for decades. However, one-shot cardioplegia is becoming more commonly used and is likely to be a valuable alternative. Some surgeons prefer the comfort of single-shot cardioplegia while others feel more confident with shorter re-dosing intervals. There is no guarantee that a single strategy can be safely applied to all patients, irrespective of their age, comorbidities or cardiopathy. The goal of this review is to discuss the rationale for short re-dosing intervals.

  19. Prostatic Artery Embolization (PAE) for Symptomatic Benign Prostatic Hyperplasia (BPH): Part 2, Insights into the Technical Rationale

    Sun, Fei, E-mail: feisun@ccmijesususon.com; Crisóstomo, Verónica, E-mail: crisosto@ccmijesususon.com; Báez-Díaz, Claudia, E-mail: cbaez@ccmijesususon.com; Sánchez, Francisco M., E-mail: msanchez@ccmijesususon.com [Jesús Usón Minimally Invasive Surgery Centre (Spain)

    2016-02-15

    Rationale of prostatic artery embolization (PAE) in the treatment of symptomatic benign prostatic hyperplasia is conventionally believed to include two parts: shrinkage of the enlarged prostate gland as a result of PAE-induced ischemic infarction and potential effects to relax the increased prostatic smooth muscle tone by reducing the number and density of α{sub 1}-adrenergic receptor in the prostate stroma. This review describes new insights into the likely mechanisms behind PAE, such as ischemia-induced apoptosis, apoptosis enhanced by blockage of androgens circulation to the embolized prostate, secondary denervation following PAE, and potential effect of nitric oxide pathway immediately after embolization. Studies on therapeutic mechanisms in PAE may shed light on potentially new treatment strategies and development of novel techniques.

  20. Glycemic control in cardiac surgery: Rationale and current evidence

    G Girish

    2014-01-01

    Full Text Available Studies in cardiac surgical patients have shown an association of hyperglycemia with increased incidences of sepsis, mediastinitis, prolonged mechanical ventilation, cardiac arrhythmias and longer intensive care and hospital stay. There is considerable controversy regarding appropriate glycemic management in these patients and in the definition of hyperglycemia and hypoglycemia or the blood sugar levels at which therapy should be initiated. There is also dilemma regarding the usage of "tight glycemic control" with studies showing conflicting evidences. Part of the controversy can be explained by the differing designs of these studies and the variable definitions of hyperglycemia and hypoglycemia.

  1. Treatment rationale and study design for a phase III, double-blind, placebo-controlled study of maintenance pemetrexed plus best supportive care versus best supportive care immediately following induction treatment with pemetrexed plus cisplatin for advanced nonsquamous non-small cell lung cancer

    To improve the efficacy of first-line therapy for advanced non-small cell lung cancer (NSCLC), additional maintenance chemotherapy may be given after initial induction chemotherapy in patients who did not progress during the initial treatment, rather than waiting for disease progression to administer second-line treatment. Maintenance therapy may consist of an agent that either was or was not present in the induction regimen. The antifolate pemetrexed is efficacious in combination with cisplatin for first-line treatment of advanced NSCLC and has shown efficacy as a maintenance agent in studies in which it was not included in the induction regimen. We designed a phase III study to determine if pemetrexed maintenance therapy improves progression-free survival (PFS) and overall survival (OS) after cisplatin/pemetrexed induction therapy in patients with advanced nonsquamous NSCLC. Furthermore, since evidence suggests expression levels of thymidylate synthase, the primary target of pemetrexed, may be associated with responsiveness to pemetrexed, translational research will address whether thymidylate synthase expression correlates with efficacy outcomes of pemetrexed. Approximately 900 patients will receive four cycles of induction chemotherapy consisting of pemetrexed (500 mg/m2) and cisplatin (75 mg/m2) on day 1 of a 21-day cycle. Patients with an Eastern Cooperative Oncology Group performance status of 0 or 1 who have not progressed during induction therapy will randomly receive (in a 2:1 ratio) one of two double-blind maintenance regimens: pemetrexed (500 mg/m2 on day 1 of a 21-day cycle) plus best supportive care (BSC) or placebo plus BSC. The primary objective is to compare PFS between treatment arms. Secondary objectives include a fully powered analysis of OS, objective tumor response rate, patient-reported outcomes, resource utilization, and toxicity. Tumor specimens for translational research will be obtained from consenting patients before induction treatment

  2. 中国人群孕前队列研究先兆子痫:原理、研究方法和基线结果%A pre-conception cohort to study preeclampsia in China:Rationale, study design, and preliminary results

    文师吾; 谭红专; 谢日华; Graeme N. Smith; Mark Walker

    2012-01-01

    目的:目前尚不清楚先兆子痫是由孕前因素还是妊娠因素所引起.本研究通过在中国湖南地区建立孕前队列以阐明先兆子痫的病因.方法:本研究拟在湖南浏阳地区招募5000对半年内有怀孕打算的未孕夫妇,并追踪研究对象的怀孕、分娩及产后情况.结果:目前本孕前队列共招募了1915对未孕夫妇.与孕前相比较,产妇的收缩压和舒张压在孕中早期有所下降,然而在孕后期有所上升.结论:孕前队列的建立将对孕期先兆子痫及产后心血管疾病的预防发挥重要的理论和实际意义.%Objective: It is uncertain whether preeclampsia (PE) is caused by pre-existing factors or by pregnancy itself. We want to answer this important question in public health by conducting a large pre-conception cohort in China.Methods: A prospective and pre-conception cohort study with a target recruitment of 5000 couples who plan to have a baby within 6 months was performed and their conception, delivery, and postpartum were followed up in Liuyang county, Hunan Province of P. R. China. Results: A total of 1915 young couples have been recruited into this unique pre-conception cohort till now. In general, both systolic blood pressure and diastolic blood pressure decreased in early second trimester from pre-conception level but increased in third trimester and at delivery. Conclusion: The proposed pre-conception cohort study will have important theoretical and practical implications on the prevention of PE and its associated cardiovascular disease risks.

  3. Phenomenological Analysis of Rationale for School Transfer Credit Policies

    Melton, Amye M.

    2012-01-01

    Students face challenges when attempting to transfer college credits; sometimes, the process results in having to retake classes already completed at another institution. A qualitative phenomenological study, grounded in an advocacy/participatory worldview, was used to explore how leaders of higher learning institutions determined reasons academic…

  4. Zero Tolerance Policy in Schools: Rationale, Consequences, and Alternatives.

    Casella, Ronnie

    2003-01-01

    Discusses theory/policies supporting zero tolerance policy in schools, including rational choice theory in criminology and national crime policies based on deterrence. Potential consequences of zero tolerance policy implementation are described and shown to involve outcomes similar to those identified by researchers studying national crime policy.…

  5. Task Force of the EFMI Journals: Background, Rationale and Purpose

    Masic, I.; Kern, J.; Zvárová, Jana; de Lusignan, S.

    Amsterdam : IOS Press, 2009 - (Adlassnig, K.; Blobel, P.; Mantas, J.; Masic, I.), s. 946-950 ISBN 978-1-60750-044-5. - (Studies in Health Technology and Informatics. 150). [MIE 2009. International Congress of the European Federation for Medical Informatics /22./. Sarajevo (BA), 30.08.2009-02.09.2009] Institutional research plan: CEZ:AV0Z10300504 Keywords : EFMI * mission statement * task force of medical informatics journals Subject RIV: IN - Informatics, Computer Science

  6. Rationale for construction vibration for drying granular and granular materials

    Зозуляк, Ігор Анатолійович

    2014-01-01

    Various processing methods are used to bring grain to a steady state for storage, provide quantitative and qualitative grain characteristics, the most effective of which is grain drying. The results of experimental studies of vibration drying and industrial equipment operation experience showed the following benefits of using vibrations in drying dispersed materials: intensive mixing of material particles, intensive moisture removal due to constant renewal of moisture exchange surface, materi...

  7. Strength Training for Arthritis Trial (START): design and rationale

    Messier, Stephen P.; Mihalko, Shannon L.; Beavers, Daniel P.; Nicklas, Barbara J.; DeVita, Paul; Carr, J. Jeffery; Hunter, David J.; Williamson, Jeff D.; Kim L Bennell; Guermazi, Ali; Lyles, Mary; Richard F Loeser

    2013-01-01

    Background Muscle loss and fat gain contribute to the disability, pain, and morbidity associated with knee osteoarthritis (OA), and thigh muscle weakness is an independent and modifiable risk factor for it. However, while all published treatment guidelines recommend muscle strengthening exercise to combat loss of muscle mass and strength in knee OA patients, previous strength training studies either used intensities or loads below recommended levels for healthy adults or were generally short,...

  8. Behavioral Couples Therapy for Substance Abuse: Rationale, Methods, and Findings

    Fals-Stewart, William; O’Farrell, Timothy J.; Birchler, Gary R.

    2004-01-01

    Behavioral couples therapy (BCT), a treatment approach for married or cohabiting drug abusers and their partners, attempts to reduce substance abuse directly and through restructuring the dysfunctional couple interactions that frequently help sustain it. In multiple studies with diverse populations, patients who engage in BCT have consistently reported greater reductions in substance use than have patients who receive only individual counseling. Couples receiving BCT also have reported higher...

  9. Synergy as a rationale for phage therapy using phage cocktails

    Matthew Schmerer; Molineux, Ian J.; Bull, James J

    2014-01-01

    Where phages are used to treat bacterial contaminations and infections, multiple phages are typically applied at once as a cocktail. When two or more phages in the cocktail attack the same bacterium, the combination may produce better killing than any single phage (synergy) or the combination may be worse than the best single phage (interference). Synergy is of obvious utility, especially if it can be predicted a priori, but it remains poorly documented with few examples known. This study add...

  10. Hospital without dyspnea: rationale and design of a multidisciplinary intervention.

    Vicent, Lourdes; Olarte, Juan Manuel Nuñez; Puente-Maestu, Luis; Artajona, Esther; Fernández-Avilés, Francisco; Martínez-Sellés, Manuel

    2016-07-01

    Dyspnea is a common and disabling symptom of respiratory and heart diseases, which is growing in incidence. During hospital admission, breathlessness is under-diagnosed and under-treated, although there are treatments available for controlling the symptom. We have developed a tailored implementation strategy directed to medical staff to promote the application of these pharmacological and non-pharmacological tools in dealing with dyspnea. The primary aim is to decrease the rate of patients that do not receive an adequate relief of dyspnea. This is a four-stage quasi-experimental study. The intervention consists in two teaching talks that will be taught in Cardiology and Respiratory Medicine Departments. The contents will be prepared by Palliative Care specialists, based on available tools for management of dyspnea and patients' needs. A cross-sectional study of dyspnea in hospitalized patients will be performed before and after the intervention to ascertain an improvement in dyspnea intensity due to changes in medical practices. The last phase consists in the creation of consensus protocols for dyspnea management based in our experience. The results of this study are expected to be of great value and may change clinical practice in the near future and promote a changing for the better of dyspnea care. PMID:27605944

  11. Rationale simplified hardening training and recreational complexes future teachers

    Verbludov I.B.

    2010-02-01

    Full Text Available Distribution in the modern world epidemiological diseases are influenza and acute respiratory viral infections requires a search for simplified, effective preventive means. The main direction of prevention of these diseases is to strengthen and enhance the activities of the immune system. Strengthening the protective systems of the body is directly related to the constant holding of different types of hardening. This study illustrates the possibility of using quenching air and water in the independent exercise training and recreational facilities in all conditions of students.

  12. The rationale for early intervention in schizophrenia and related disorders

    Nordentoft, Merete; Jeppesen, Pia; Petersen, Lone;

    2009-01-01

    , adherence to treatment, comorbid drug abuse, relapse and readmission. Some benefits persist after cessation of the intervention. Conclusions: Early intervention in schizophrenia is justified to reduce the negative personal and social impact of prolonged periods of untreated symptoms. Furthermore, phase...... initiation of treatment. The average duration of untreated psychosis is around 1–2 years. During this period, brain function may continue to deteriorate and social networks can be irreversibly damaged. Studies have consistently linked longer duration of untreated psychosis with poorer outcomes and this...

  13. Rationale and Design of the Access Specification Language RASP

    Mark Evered

    2014-05-01

    Full Text Available In this paper we describe the formal specification language RASP for expressing fine-grained access control constraints in information systems. The design of the language is motivated by a number of IS case studies which demonstrate the complexity of the access constraints which arise if minimal (need-to-know access is to be strictly enforced. RASP supports modularity, parameterization, role acquisition, constraint expressions and a symmetrical approach to role transitions and attribute transitions. No existing access control specification language supports all of these complex, realistic requirements.

  14. Chemical rationale for selection of isolates for genome sequencing

    Rank, Christian; Larsen, Thomas Ostenfeld; Frisvad, Jens Christian

    The advances in gene sequencing will in the near future enable researchers to affordably acquire the full genomes of handpicked isolates. We here present a method to evaluate the chemical potential of an entire species and select representatives for genome sequencing. The selection criteria for new...... strains to be sequenced can be manifold, but for studying the functional phenotype, using a metabolome based approach offers a cheap and rapid assessment of critical strains to cover the chemical diversity. We have applied this methodology on the complex A. flavus/A. oryzae group. Though these two species...

  15. IMMEDIATE VERSUS DELAYED LOADING IMPLANTS: RATIONALE AND CONTROVERSIES.

    Corradini, G; Delle Donne, U; Boni, W; Tettamanti, L; Tagliabue, A

    2015-01-01

    Loading implants immediately after their position in alveolar bone crest is a procedure that has become popular in the last decade. The aim of this study is to evaluate the survival rate of 811 immediate loaded implants (ILIs). In the period between January 2008 and December 2013, 877 patients (498 females and 379 males) were operated at the BDD private Practice Clinic (Milan, Italy). The mean post-surgical follow-up was 30±17 months (max – min, 84 – 1). One thousasnd three hundred and eighty-six fixtures (EDIERRE Implant System SpA, Genoa, Italy) were evaluated in the present study, 811 immediately loaded and 575 loaded after 3 months. All patients underwent the same surgical protocol and agreed to participate in a post-operative check-up program. SPSS program was used for statistical analysis. Survival rate (SVR) was 97.3% since only 38 fixtures were lost from a total of 1,348 implants. Cross-tabulation between failures demonstrated slight but significant worse results for ILIs (p= 0.037). There were 28 failures out of 811 ILIs whereas only 10 fixtures were lost out of 565 implants loaded after 3 months. Immediate loading performed in selected cases is a reliable tool for oral rehabilitation. PMID:26511174

  16. Rationale for wind-borne missile criteria for DOE facilities

    McDonald, J R; Murray, R

    1999-09-01

    High winds tend to pick up and transport various objects and debris, which are referred to as wind-borne missiles or tornado missiles, depending on the type of storm. Missiles cause damage by perforating the building envelope or by collapsing structural elements such as walls, columns or frames. The primary objectives of this study are as follows: (1) to provide a basis for wind-borne or tornado missile criteria for the design and evaluation of DOE facilities, and (2) to provide guidelines for the design and evaluation of impact-resistant missile barriers for DOE facilities The first objective is accomplished through a synthesis of information from windstorm damage documentation experience and computer simulation of missile trajectories. The second objective is accomplished by reviewing the literature, which describes various missile impact tests, and by conducting a series of impact tests at a Texas Tech University facility to fill in missing information.

  17. [Anatomical rationale for lingual nerve injury prevention during mandibular block].

    Semkin, V A; Dydikin, S S; Kuzin, A V; Sogacheva, V V

    2015-01-01

    The topographic and anatomical study of lingual nerve structural features was done. It was revealed that during mandibular anesthesia possible lingual nerve injury can occur if puncture needle is lower than 1 cm. of molars occlusal surface level. The position of the lingual nerve varies withmandible movements. At the maximum open mouth lingual nerve is not mobile and is pressed against the inner surface of the mandibular ramus by the medial pterygoid muscle and the temporal muscle tendon. When closing the mouth to 1.25±0.2 cmfrom the physiological maximum, lingual nerve is displaced posteriorly from the internal oblique line of the mandible and gets mobile. On the basis of topographic and anatomic features of the lingual nervestructure the authors recommend the re-do of inferior alveolar nerve block, a semi-closed mouth position or the use the "high block techniques" (Torus anesthesia, Gow-Gates, Vazirani-Akinozi). PMID:26271698

  18. LCoMotion – Learning, Cognition and Motion; a multicomponent cluster randomized school-based intervention aimed at increasing learning and cognition - rationale, design and methods

    Bugge, Anna; Tarp, Jakob; Østergaard, Lars; Domazet, Sidsel Louise; Andersen, Lars Bo; Froberg, Karsten

    2014-01-01

    Background The aim of the study; LCoMotion – Learning, Cognition and Motion was to develop, document, and evaluate a multi-component physical activity (PA) intervention in public schools in Denmark. The primary outcome was cognitive function. Secondary outcomes were academic skills, body composition, aerobic fitness and PA. The primary aim of the present paper was to describe the rationale, design and methods of the LCoMotion study. Methods/Design LCoMotion was designed as a cluster-randomize...

  19. Resistance to Healing the Wounded Self: A Psychodynamic Rationale for a Targeted Treatment.

    Barabasz, Arreed; Barabasz, Marianne; Christensen, Ciara

    2016-07-01

    The purpose of this article is to shed light on the psychodynamic complexities of the resistance encountered in treating the wounded self. Conceptualized on the basis of ego state therapy it offers a rationale for the use of precision-targeted abreactive hypnosis to treat these patients. Grounded in evidence-based efficacy research, the authors also briefly explain how to target treatment in wounded-self patients. PMID:27196012

  20. Playing `Hard to Get': An Economic Rationale for Crowding Out of Intrinsically Motivated Behaviour

    Wendelin Schnedler; Christoph Vanberg

    2014-01-01

    Anecdotal, empirical, and experimental evidence suggests that offering extrinsic rewards for certain activities can reduce people's willingness to engage in those activities voluntarily. We propose a simple rationale for this `crowding out' phenomenon, using standard economic arguments. The central idea is that the potential to earn rewards in return for an activity may create incentives to play `hard to get' in an effort to increase those rewards. We discuss two specific contexts in which su...

  1. Playing 'Hard to Get': An Economic Rationale for Crowding Out of Intrinsically Motivated Behavior

    Schnedler, Wendelin; Vanberg, Christoph

    2014-01-01

    Anecdotal, empirical, and experimental evidence suggests that offering extrinsic rewards for certain activities can reduce people's willingness to engage in those activities voluntarily. We propose a simple rationale for this 'crowding out' phenomenon, using standard economic arguments. The central idea is that the potential to earn rewards in return for an activity may create incentives to play 'hard to get' in an effort to increase those rewards. We discuss two specific contexts in which su...

  2. Rationales for public policy intervention from a systems of innovation approach: the case of VINNOVA

    Chaminade , Cristina; Edquist, Charles

    2006-01-01

    This paper discusses the implications of the adoption of the National Innovation Systems approach for innovation policy. It starts by positioning the 'systemic' approach against other theoretical approaches, such as neoclassical theories. The authors argue that the adoption of one or the other frameworks leads to different criteria for intervention. The main rationales for public intervention under each approach are then discussed. We make a distinction between classic market failures (ground...

  3. Sildenafil in heart failure with reactive pulmonary hypertension (Sildenafil HF) clinical trial (rationale and design)

    Guglin, Maya; Rajagopalan, Navin; Anaya, Paul; Charnigo, Richard

    2016-01-01

    In this article, we present the rationale and design of the Sildenafil HF trial (ClinicalTrials.gov identifier: NCT02304705). We will randomize patients with heart failure and reactive pulmonary hypertension (pulmonary capillary wedge pressure > 15 mmHg, pulmonary vascular resistance > 3 Wood units) into two groups: the treatment group receiving sildenafil 20 mg 3 times a day and a matching placebo group. The duration of intervention will be 3 months. The primary outcome is 6-minute walk dist...

  4. Corporate Real Estate Unit Formation: Rationale, Industry, and Type of Unit

    Ronald C. Rutherford; Stone, Robert W.

    1989-01-01

    This research investigates relationships between a corporation's rationale for forming a Corporate Real Estate Unit (CREU), its industry, and the type of CREU formed. Four conclusions are offered. First, there is no significant relationship between industry and the type of CREU formed. Second, relationships exist between the formation motives and the corporation's industry. Third, CREU formation by wholly owned subsidiaries is likely to be motivated by development and profits, while centraliz...

  5. Glucosamine and chondroitin sulfate supplementation to treat symptomatic disc degeneration: Biochemical rationale and case report

    van de Nes Jos CM; Wuisman Paul IJM; van Blitterswijk Wim J

    2003-01-01

    Abstract Background Glucosamine and chondroitin sulfate preparations are widely used as food supplements against osteoarthritis, but critics are skeptical about their efficacy, because of the lack of convincing clinical trials and a reasonable scientific rationale for the use of these nutraceuticals. Most trials were on osteoarthritis of the knee, while virtually no documentation exists on spinal disc degeneration. The purpose of this article is to highlight the potential of these food additi...

  6. Aerobic Exercise for Alcohol Recovery: Rationale, Program Description, and Preliminary Findings

    Brown, Richard A.; Abrantes, Ana M.; Read, Jennifer P.; Marcus, Bess H.; Jakicic, John; Strong, David R.; Oakley, Julie R.; Ramsey, Susan E.; Kahler, Christopher W.; Stuart, Gregory G.; Dubreuil, Mary Ella; Gordon, Alan A.

    2008-01-01

    Alcohol use disorders are a major public health concern. Despite the demonstrated efficacy of a number of different treatments for alcohol dependence, relapse remains a major problem. Healthy lifestyle changes may contribute to long-term maintenance of recovery and interventions targeting physical activity, in particular, may be especially valuable as an adjunct to alcohol treatment. In this paper, we discuss the rationale and review potential mechanisms of action whereby exercise might benef...

  7. Rationale for human modelling in human in the loop systems design

    Fass, Didier; Lieber, Romain

    2009-01-01

    Human modelling in human-in-the-loop systems (HITLS) design can be a complex and dynamic endeavour. Thereby it needs a theoretical framework for grounding methods and models on verified principals and an integrative approach that takes into consideration the specificity of biological organization of living systems, according to the principles of physics, and a coherent way to organize and integrate structural and functional artificial elements. This paper focuses on the rationale of human mod...

  8. Establishing assessment scales using a novel disciplinary rationale for scientific reasoning.

    Kind, P.

    2013-01-01

    The article argues that science assessment should change from an item-driven to a construct-driven practice and pay more attention to disciplinary scientific reasoning. It investigates assessment scales developed from a novel theoretical rationale, describing scientific reasoning as three fundamental practices (hypothesizing, experimenting, and evidence evaluation) and building on three types of knowledge (science content knowledge, procedural knowledge, and epistemic knowledge). The scale de...

  9. Individual savings accounts for social insurance:rationale and alternative designs

    Bovenberg, A.L.; Hansen, M.; Sorensen, P.B.

    2008-01-01

    Using Danish data, we find that about three-fourths of the taxes levied to finance public transfers actually finance benefits that redistribute income over the life cycle of individual taxpayers rather than redistribute resources across people. This finding and similar results for other countries provide a rationale for financing part of social insurance via mandatory individual savings accounts. We discuss the advantages and disadvantages of mandatory individual savings accounts for social i...

  10. Artificial Intelligence Rationale for Autonomous Vehicle Agents Behaviour in Driving Simulation Environment

    Charissis, Vassilis; Papanastasiou, Stylianos

    2008-01-01

    This chapter presented the rationale and development process of an open source driving simulator which was exclusively created for the evaluation process of a prototype HUD interface. Financial limitations led to the exploration of new avenues for evaluating the prototype HUD. The simulator hardware was built using off-the-shelf components and the software was developed through customisation of an open source code game engine. For evaluation purposes, equal emphasis was placed on was the deve...

  11. The Management Development Institute of Singapore in Tashkent (MDIST), Uzbekistan: Motives and Rationale

    Eng Kee Sia

    2014-01-01

    This article provides an overview of international branch campuses (IBCs) in the context of higher education reforms in Uzbekistan. It also discusses the motives and rationale of establishing the Management Development Institute of Singapore in Tashkent (MDIST) in Uzbekistan based on the Institution Theory, shares its successes and reveals its uniqueness for transnational higher education provision. The purpose of this article does not seek to break new grounds within the transnational higher...

  12. The rationale behind the development of an airline operations control centre using Gaia-based methodology.

    Castro, Antonio J.M.; Eugenio Oliveira

    2008-01-01

    In this paper, we report how we complemented Gaia methodology to analyse and design a multi-agent system for an airline company operations control centre. Besides showing the rationale behind the analysis, design and implementation of our system, we also present how we mapped the abstractions used in agent-oriented design to specific constructs in JADE. The advantages of using a goal-oriented early requirements analysis and its influence on subsequent phases of analysis and design are also pr...

  13. Tangential breast irradiation - rationale and methods for improving dosimetry

    In recent years there have been great advances and innovations in all technical aspects of radiotherapy, including three dimensional (3D) computer planning, patient immobilization, radiation delivery and treatment verification. Despite this progress, the technique of tangential breast irradiation has changed little over this period and has not exploited these advances. There is increasing evidence that dose inhomogeneity within the breast is greater than at other anatomical sites, especially in women with large breasts. This paper is a review of the factors contributing to poor dosimetry in the breast, the clinical consequences of an inhomogeneous dose distribution, and how breast dosimetry could be improved by considering each of the stages from planning to accurate treatment delivery. It also highlights the particular problem of women with large breasts who may be more likely to have a poorer outcome after a fractionated course of radiotherapy than women with small/medium-sized breasts, and supports the clinical impression that such women are also more likely to have greater inhomogenicity when 3D treatment plans are examined. Preliminary data from our current computed tomography (CT) planning study are presented to support these observations. (author)

  14. Accelerated partial breast irradiation trials: Diversity in rationale and design

    Seven randomised trials are currently testing accelerated partial breast irradiation against whole breast radiotherapy after breast conservation surgery. The trials are varied in the techniques used to deliver partial breast radiotherapy, reflecting the range of opportunities offered by advanced brachytherapy and teletherapy modalities. Dose schedules also vary between trials, but the most important point of difference between them reflects alternative concepts of clinical and planning target volumes. These are based mainly on the spatial pattern of relapse in retrospective and prospective studies, which report the majority of first local relapses close to the primary tumour site, and on the assumption that radiotherapy does not prevent the development of new primary tumours developing elsewhere in the breast. However, the pattern of ipsilateral breast tumour relapse is not accurately defined in the clinical literature and does not correspond closely to pathological findings. In addition, published data are consistent with a significant reduction in the rate of other quadrant relapse after whole breast radiotherapy. Regardless of the biological model of local tumour relapse and responsiveness to radiation, the ongoing trials will generate level I evidence for or against accelerated partial breast irradiation, provided patients are followed up long enough before the first reporting of results.

  15. Rationale for early treatment of polycystic kidney disease.

    Grantham, Jared J

    2015-07-01

    In hereditary cystic disorders, renal injury begins with the formation of the first cyst. Renal injury may manifest as large kidneys, abdominal pain, hypertension and hematuria in children and young adults with autosomal dominant polycystic kidney disease (ADPKD). In autosomal recessive PKD (ARPKD) and ADPKD, cysts form primarily in collecting ducts and expand progressively. Collecting duct cysts that block urine flow have the potential to block urine formation in large numbers of upstream nephrons. In an ARPKD rat congenitally lacking vasopressin, only a few cysts developed until exogenous arginine vasopressin (AVP) was administered. AVP elevates cyclic AMP in vulnerable tubule cells to stimulate mitogenesis and fluid secretion, thereby causing cysts to form and enlarge indefinitely. The administration of an AVP-V2 receptor inhibitor or the consumption of sufficient water to persistently lower plasma AVP levels will ameliorate disease progression. Renal volume measurements provide the most reliable way to forecast long-term outcome in individual children and adult patients with ADPKD. Many drugs that have demonstrated efficacy in small clinical trials, preclinical trials and cell-based studies are in the treatment pipeline. Counseling, regular exercise, limitation of dietary calories, salt, protein and fat, increased fluid intake throughout the day and treatment of hypertension are components of a rational treatment program that can be offered at an early age to those with, or at risk for developing PKD. PMID:25022529

  16. The DAE{\\delta}ALUS Project: Rationale and Beam Requirements

    Alonso, Jose R

    2010-01-01

    Neutrino physics focuses on huge detectors deep underground. The Sanford Lab in South Dakota will build a 300 kiloton water-Cherenkov detector 1500 meters deep for muon neutrino oscillation studies of the mass hierarchy and CP violation. This will be used by the Long Baseline experiment (LBNE) detecting few GeV neutrinos from Fermilab, 1300 km away. The DAE{\\delta}ALUS Collaboration also plans several neutrino-production sites at closer distances up to 20 km from the 300 kT detector, producing muon antineutrinos from stopped pions. The complementarity with LBNE greatly enhances results, and enthusiasm is mounting to do both experiments. DAE{\\delta}ALUS needs 0.8-1 GeV accelerators with mA proton beams. Three sites at 1.5, 8 and 20 km from the 300 kT detector require several accelerators. The cost per machine must be below 1/10 of existing megawatt-class proton machines. Beyond high power and energy, beam parameters are modest. Challenges are reliability, control of beam loss and minimizing activation. Options...

  17. Rationale and clinical data supporting nutritional intervention in Alzheimer's disease.

    Engelborghs, S; Gilles, C; Ivanoiu, A; Vandewoude, M

    2014-01-01

    Adequate nutrition plays an important role in the maintenance of cognitive function, particularly during aging. Malnutrition is amongst the risk factors for developing mild cognitive impairment (MCI) and Alzheimer's disease (AD). Epidemiological studies have associated deficiencies in some nutrients with a higher risk of cognitive dysfunction and/or AD. Cognitive decline in AD is correlated with synaptic loss and many of the components required to maintain optimal synaptic function are derived from dietary sources. As synapses are part of the neuronal membrane and are continuously being remodelled, the availability of sufficient levels of nutritional precursors (mainly uridine monophosphate, choline and omega-3 fatty acids) to make the phospholipids required to build neuronal membranes may have beneficial effects on synaptic degeneration in AD. In addition, B-vitamins, phospholipids and other micronutrients act as cofactors to enhance the supply of precursors required to make neuronal membranes and synapses. Despite this, no randomized controlled trial has hitherto provided evidence that any single nutrient has a beneficial effect on cognition or lowers the risk for AD. However, a multi-target approach using combinations of (micro)nutrients might have beneficial effects on cognitive function in neurodegenerative brain disorders like AD leading to synaptic degeneration. Here we review the clinical evidence for supplementation, based on a multi-target approach with a focus on key nutrients with a proposed role in synaptic dysfunction. Based on preclinical evidence, a nutrient mixture, Souvenaid(®) (Nutricia N.V., Zoetermeer, The Netherlands) was developed. Clinical trials with Souvenaid(®) have shown improved memory performance in patients with mild AD. Further clinical trials to evaluate the effects of nutritional intervention in MCI and early dementia due to AD are on-going. PMID:24635394

  18. Performance enhancement with supplements: incongruence between rationale and practice

    Mazanov Jason

    2007-11-01

    Full Text Available Abstract Background Athletes are expected to consider multiple factors when making informed decision about nutritional supplement use. Besides rules, regulations and potential health hazards, the efficacy of different nutritional supplements in performance enhancement is a key issue. The aim of this paper was to find evidence for informed decision making by investigating the relationship between specific performance-related reasons for supplement use and the reported use of nutritional supplements. Methods The 'UK Sport 2005 Drug Free Survey' data (n = 874 were re-analysed using association [χ2] and 'strength of association' tests [ϕ] to show the proportion of informed choices and to unveil incongruencies between self-reported supplement use and the underlying motives. Results Participants (n = 520 reported supplement use in the pattern of: vitamin C (70.4%, creatine (36.1%, whey protein (30.6%, iron (29.8%, caffeine (23.8%, and ginseng (8.3% for the following reasons: strength maintenance (38.1%, doctors' advice (24.2%, enhancing endurance (20.0%, ability to train longer (13.3%, and provided by the governing body (3.8%. Of thirty possible associations between the above supplements and reasons, 11 were predictable from literature precedents and only 8 were evidenced and these were not strong (ϕ 2 = 49.14, p 2 = 97.08, p 2 = 97.82, p Conclusion This study provided a platform for assessing congruence between athletes' reasons for supplement use and their actual use. These results suggest that a lack of understanding exists in supplement use. There is an urgent need to provide accurate information which will help athletes make informed choices about the use of supplements.

  19. Science Rationale for the Io Volcano Observer (IVO) Mission Concept

    McEwen, Alfred; Turtle, Elizabeth

    2012-07-01

    The Io Volcano Observer (IVO) mission can explore the rich array of interconnected orbital, geophysical, atmospheric, and plasma phenomena surrounding the most volcanically active world in the Solar System. Io is the only place in the Solar System (including Earth) where we can watch very large-scale silicate volcanic processes in action, and it provides unique insight into high-temperature and high effusion-rate volcanic processes that were important in the early histories of the terrestrial planets. Io is also the best target at which to study tidal heating, which greatly expands the habitable zones of planetary systems. Moreover, the coupled orbital-tidal evolution is key to understanding the thermal histories of Europa and Ganymede. Io is always inside the intense radiation belt of Jupiter, so a radiation-mitigation strategy has been developed. An inclined orbit that passes Io at high velocity (˜19 km/s) near its perijove point keeps the total ionizing dose to ˜10 krad (behind 2.5 mm or 100 mils Al) per encounter. Nevertheless, the dose rate is high near Io so some science instruments have special design considerations to minimize noise. The IVO spacecraft must be agile enough (rapid turning and settling) for high-stability targeted observations during close encounters. The inclined orbit provides nearly pole-to-pole flybys of Io, which enables some of the highest-priority Io science such as understanding the polar heat flow and electrical conductivity of Io's mantle (which may contain a magma ocean). Key science instruments include narrow- and wide-angle cameras, magnetometers, a thermal mapper, neutral mass spectrometers, and plasma ion analyzers. NASA's 2011 Decadal Survey for planetary science identified an Io mission similar to IVO as one of seven options for the next two New Frontiers mission opportunities. The Galileo (GLL) mission and payload were designed prior to the Voyager 1 flyby and discovery of Io's active volcanism, so they were not designed

  20. Rationale and design: telepsychology service delivery for depressed elderly veterans

    Richardson Lisa K

    2009-04-01

    Full Text Available Abstract Background Older adults who live in rural areas experience significant disparities in health status and access to mental health care. "Telepsychology," (also referred to as "telepsychiatry," or "telemental health" represents a potential strategy towards addressing this longstanding problem. Older adults may benefit from telepsychology due to its: (1 utility to address existing problematic access to care for rural residents; (2 capacity to reduce stigma associated with traditional mental health care; and (3 utility to overcome significant age-related problems in ambulation and transportation. Moreover, preliminary evidence indicates that telepsychiatry programs are often less expensive for patients, and reduce travel time, travel costs, and time off from work. Thus, telepsychology may provide a cost-efficient solution to access-to-care problems in rural areas. Methods We describe an ongoing four-year prospective, randomized clinical trial comparing the effectiveness of an empirically supported treatment for major depressive disorder, Behavioral Activation, delivered either via in-home videoconferencing technology ("Telepsychology" or traditional face-to-face services ("Same-Room". Our hypothesis is that in-homeTelepsychology service delivery will be equally effective as the traditional mode (Same-Room. Two-hundred twenty-four (224 male and female elderly participants will be administered protocol-driven individual Behavioral Activation therapy for depression over an 8-week period; and subjects will be followed for 12-months to ascertain longer-term effects of the treatment on three outcomes domains: (1 clinical outcomes (symptom severity, social functioning; (2 process variables (patient satisfaction, treatment credibility, attendance, adherence, dropout; and (3 economic outcomes (cost and resource use. Discussion Results from the proposed study will provide important insight into whether telepsychology service delivery is as effective

  1. The Nonprofit Sector's Capital Constraint: Does It Provide a Rationale for the Tax Exemption Granted To Nonprofit Firms?

    Timothy J. Goodspeed; Daphne A. Kenyon

    1993-01-01

    The exemption of the nonprofit sector from the corporate income tax is an implicit subsidy that has received little attention in the nonprofit literature A fundamental question concerning this subsidy is its rationale. The present analysis suggests that the theoretical basis for the rationale previously proposed by Hansmann, that the nonprofit sector's capital constraint justifies its tax exemption, relies heavily on the output effect of exemption. The article first suggests that the nonprofi...

  2. Rationales of documentation in British Live Art since the 1990s: the pragmatic, memorial and holistic

    Wee, Cecilia Liang May

    2012-01-01

    This thesis investigates rationales behind Live Art documentation, by examining the work of British artists working under the banner of ‘Live Art’ since the 1990s. My aim has been to write an account of Live Art’s history and major themes that incorporates primary research, analysis and criticism of recent research on documentation. Works by Live Artists are not discussed chronologically, but so that they might function as points of departure for discussions about Live Art’s relationship to d...

  3. On the Economic Rationale of Vouchers in Social Policies and Private Exchanges

    Beltrametti Luca

    2010-01-01

    The paper reviews the rationale for using vouchers and the most important uses of vouchers in social policies and in private exchanges. It focuses on the most significant programs at the European level, also in relation with the American food stamps, on the Italian «Social Card», and on other relevant regional experiences. Private uses concern the Italian «buono lavoro» and gift and incentive vouchers. Furthermore, it discusses the motivations that the economic theory provides in order to sup...

  4. Theoretical Rationale of Heating Block for Testing Bench of Aerospace Crafts Thermal Protection Elements

    Petrova, Anna A.; Reznik, Sergey V.

    2016-02-01

    The theoretical rationale for the structural layout of a testing bench with zirconium dioxide heating elements on the basis of modelling radiative-conductive heat transfer are presented. The numerical simulation of radiative-conductive heat transfer for the two-dimensional scaled model of the testing segment with the finite-element analysis software package Ansys 15.0 are performed. The simulation results showed that for the selected layout of the heaters the temperature non-uniformity along the length of the sample over time will not exceed 3 % even at a temperature of 2000 K.

  5. Rationale for Therapeutic Silencing of Alpha-Synuclein in Parkinson’s Disease

    Demetrius M. Maraganore

    2011-05-01

    Full Text Available The purpose of this paper is to provide the rationale for therapeutic silencing of the alpha-synuclein gene (SNCA in Parkinson’s disease (PD. The paper reviews the public health significance of PD; the causal links between rare SNCA variants and familial PD; the association of common SNCA variants and PD susceptibility; the association of SNCA variants also with age at onset and motor and cognitive outcomes in PD; therapeutic strategies targeting SNCA in PD; and preliminary findings and considerations on small interfering RNA-based therapies and PD.

  6. Preliminary design specification for Department of Energy standardized spent nuclear fuel canisters. Volume 2: Rationale document

    This document (Volume 2) is a companion document to a preliminary design specification for the design of canisters to be used during the handling, storage, transportation, and repository disposal of Department of Energy (DOE) spent nuclear fuel (SNF). This document contains no procurement information, such as the number of canisters to be fabricated, explicit timeframes for deliverables, etc. However, this rationale document does provide background information and design philosophy in order to help engineers better understand the established design criteria (contained in Volume 1 respectively) necessary to correctly design and fabricate these DOE SNF canisters

  7. Splinting rationale and contemporary treatment options for luxated and avulsed permanent teeth.

    Lambert, Douglas L

    2015-01-01

    The continued growth in athletic participation among children and adults has increased the potential incidence of sports-related dental injuries. Regardless of preventive measures, damage and injury to the oral cavity can occur during participation in sports. Luxations, root fractures, bony fractures, and avulsions involving 1 or more teeth are a possibility. Many of these injuries require specific protocols for splinting of the traumatized tooth or teeth to allow the best possible outcomes. This article identifies luxation and avulsion injuries, explains the rationale for splinting, reviews guidelines for splint duration, and discusses contemporary material options available to stabilize affected permanent dentition. PMID:26545276

  8. Enhancing measurement in science education research through Rasch analysis: Rationale and properties

    Jørgen Sjaastad

    2014-10-01

    Full Text Available This article presents the basic rationale of Rasch theory and seven core properties of Rasch modeling; analyses of test targeting, person separation, person fit, item fit, differential item functioning, functioning of response categories and tests of unidimensionality. Illustrative examples are provided consecutively, drawing on Rasch analysis of data from a survey where students in the 9th grade responded to questions regarding their mathematics competence. The relationship between Rasch theory and classical test theory is commented on. Rasch theory provides science and mathematics education researchers with valuable tools to evaluate the psychometric quality of tests and questionnaires and support the development of these.

  9. The START Study to evaluate the effectiveness of a combination intervention package to enhance antiretroviral therapy uptake and retention during TB treatment among TB/HIV patients in Lesotho: rationale and design of a mixed-methods, cluster-randomized tr

    Howard, Andrea A; Hirsch-Moverman, Yael; Frederix, Koen; Daftary, Amrita; Saito, Suzue; Gross, Tal; Wu, Yingfeng; Maama, Llang Bridget

    2016-01-01

    Background: Initiating antiretroviral therapy (ART) early during tuberculosis (TB) treatment increases survival; however, implementation is suboptimal. Implementation science studies are needed to identify interventions to address this evidence-to-program gap.Objective: The Start TB Patients on ART and Retain on Treatment (START) Study is a mixed-methods, cluster-randomized trial aimed at evaluating the effectiveness, cost-effectiveness, and acceptability of a combination intervention package...

  10. Providing a Rationale for Promoting Argument-Based Inquiry Approach to Science Education: A Deweyan Pragmatist Aesthetics Perspective

    Şevket Benhür Oral

    2012-12-01

    Full Text Available Argumentation in science education is a well-established and successful research programme. Key theoretical underpinnings of this approach come from situated cognition perspective, the theory of communicative action and the sociocultural perspective, language studies and social semiotics, philosophy of science studies, and developmental psychology. In this paper, it will be argued that all these theoretical frameworks that aim to provide a rationale for promoting argument-based inquiry approach to science education stand to benefit if their unique insights can be brought together within the theory of Deweyan pragmatist aesthetics. It is my contention that learners first need to experience the most fundamental human situation, namely, the problematic as the ontological condition of experiencing the world as a human, in carefully calibrated pedagogically appropriate settings to get the process of collaborative inquiry going. One such setting is provided by the Science Writing Heuristic (SWH, an argument-based collaborative inquiry approach to experience negotiation of meaning in relation to science content in school. It will be claimed that the SWH approach, which is an immersion-oriented argument intervention model, is successful to the extent that it enacts a learning situation whereby the process of collaborative inquiry as understood by Dewey unfolds and provides a consummatory experience for the learners as well as the teachers.

  11. History, rationale, and lessons learned: Thresholds of potential concern in Kruger National Park river adaptive management

    Craig A. McLoughlin

    2011-05-01

    Full Text Available The Kruger National Park’s (KNP adopted system of management, called Strategic Adaptive Management (SAM, originated during the Kruger National Park Rivers Research Programme (KNPRRP of the 1990s. An important concept in SAM is the thresholds of potential concern (TPCs, representing end-points in a continuum of change. TPCs within the KNP SAM system guide management if or when reached, ‘red-flagging’ possible negative biodiversity impacts and catalysing consideration of management options. TPC-related monitoring generates the strategic information for ongoing evaluation, learning and adaptation within SAM. Post- KNPRRP, although river flow and water quality TPCs have been implemented partly, those designed to detect undesirable changes in biodiversity have not been implemented, until recently. This paper describes the history, rationale, application and ongoing developments associated with the KNP river TPCs over the last decade, providing some key lessons for organisations utilising SAM. The paper concludes with an overview of new thinking and future directions envisaged for the KNP river TPCs, as part of the KNP SAM system. Conservation implications: This paper documents important concepts of strategic adaptive management associated with the KNP river systems. Understanding, related to the rationale and justification for use and development or refinement of the thresholds of potential concern, lays an important foundation for ongoing work in managing these rivers adaptively.

  12. A systematic rationale for defining the significance of aircraft noise impacts.

    Fidell, Sanford; Mestre, Vincent; Schomer, Paul; Horonjeff, Richard; Reid, Tim

    2014-09-01

    Regulatory agencies often define strict, decibel-denominated thresholds of significance of noise impacts to protect some fraction of the residential population from exposure to highly annoying noise. Definitions of the "significance" of aircraft noise impacts and recommendations of land use "compatibility," however, typically lack detailed, systematic rationales. Instead, the definitions are justified by reference to decades-old policies that were adopted without benefit of modern understandings of noise-induced annoyance, by appeals to authority, and by generic citations of non-peer reviewed documents. Although regulatory policy decisions may properly take into consideration political and economic consequences, aspects of them are amenable to logical formalization. In particular, advances in understanding of community reaction to transportation noise now permit a systematic rationale for aircraft noise regulation. The current analyses show how regulatory policy positions can be derived from two parameters: (1) the minimal percentage of the population of a nominally average community to be protected from exposure to highly annoying noise; and (2) the percentage of all communities to which this degree of protection is intended to apply. Together with a reliable dosage-response relationship, these two parameters permit quantitatively justifiable definitions of significant noise impact. PMID:25190388

  13. Direct renin inhibition in addition to or as an alternative to angiotensin converting enzyme inhibition in patients with chronic systolic heart failure: rationale and design of the Aliskiren Trial to Minimize OutcomeS in Patients with HEart failuRE (ATMOSPHERE) study

    Krum, Henry; Massie, Barry; Abraham, William T;

    2011-01-01

    S for Patients with HEart failuRE (ATMOSPHERE) study is to evaluate the effect of both aliskiren and enalapril monotherapy and aliskiren/enalapril combination therapy on cardiovascular death and HF hospitalization in patients with chronic systolic HF, NYHA functional class II-IV symptoms, and elevated plasma...... monotherapy, or the combination. The primary endpoints of ATMOSPHERE are (i) whether the aliskiren/enalapril combination is superior to enalapril monotherapy in delaying time to first occurrence of cardiovascular death or HF hospitalization and (ii) whether aliskiren monotherapy is superior or at least non......-inferior to enalapril monotherapy on this endpoint. Perspective The ATMOSPHERE study will definitively determine the role of a DRI strategy additional to or as an alternative to conventional RAAS blockade in patients with chronic systolic HF....

  14. Rationale and design of the Baptist Employee Healthy Heart Study: a randomized trial assessing the efficacy of the addition of an interactive, personalized, web-based, lifestyle intervention tool to an existing health information web platform in a high-risk employee population

    Post, Janisse M.; Ali, Shozab S.; Roberson, Lara L.; Ehimen C Aneni; Shaharyar, Sameer; Younus, Adnan; Jamal, Omar; Ahmad, Rameez; Aziz, Muhammad A.; Malik, Rehan; Spatz, Erica S.; Feldman, Theodore; Fialkow, Jonathan; Veledar, Emir; Ricardo C Cury

    2016-01-01

    Background Metabolic syndrome (MetS) and diabetes confer a high risk for developing subsequent cardiovascular disease (CVD). Persons with MetS constitute 24–34 % of the employee population at Baptist Health South Florida (BHSF), a self-insured healthcare organization. The Baptist Employee Healthy Heart Study (BEHHS) aims to assess the addition of a personalized, interactive, web-based, nutrition-management and lifestyle-management program to the existing health-expertise web platform availabl...

  15. A randomized trial of diet and physical activity in women treated for stage II-IV ovarian cancer: Rationale and design of the Lifestyle Intervention for Ovarian Cancer Enhanced Survival (LIVES): An NRG Oncology/Gynecologic Oncology Group (GOG-225) Study.

    Thomson, Cynthia A; Crane, Tracy E; Miller, Austin; Garcia, David O; Basen-Engquist, Karen; Alberts, David S

    2016-07-01

    Ovarian cancer is the most common cause of gynecological cancer death in United States women. Efforts to improve progression free survival (PFS) and quality of life (QoL) after treatment for ovarian cancer are necessary. Observational studies suggest that lifestyle behaviors, including diet and physical activity, are associated with lower mortality in this population. The Lifestyle Intervention for Ovarian Cancer Enhanced Survival (LIVES) NRG 0225 study is a randomized, controlled trial designed to test the hypothesis that a 24month lifestyle intervention will significantly increase PFS after oncological therapy for stage II-IV ovarian cancer. Women are randomized 1:1 to a high vegetable and fiber, low-fat diet with daily physical activity goals or an attention control group. Secondary outcomes to be evaluated include QoL and gastrointestinal health. Moreover an a priori lifestyle adherence score will be used to evaluate relationships between adoption of the diet and activity goals and PFS. Blood specimens are collected at baseline, 6, 12 and 24months for analysis of dietary adherence (carotenoids) in addition to mechanistic biomarkers (lipids, insulin, telomere length). Women are enrolled at NRG clinic sites nationally and the telephone based lifestyle intervention is delivered from The University of Arizona call center by trained health coaches. A study specific multi-modal telephone, email, and SMS behavior change software platform is utilized for information delivery, coaching and data capture. When completed, LIVES will be the largest behavior-based lifestyle intervention trial conducted among ovarian cancer survivors. PMID:27394382

  16. Randomized comparison of operator radiation exposure comparing transradial and transfemoral approach for percutaneous coronary procedures: rationale and design of the minimizing adverse haemorrhagic events by TRansradial access site and systemic implementation of angioX – RAdiation Dose study (RAD-MATRIX)

    Background: Radiation absorbed by interventional cardiologists is a frequently under-evaluated important issue. Aim is to compare radiation dose absorbed by interventional cardiologists during percutaneous coronary procedures for acute coronary syndromes comparing transradial and transfemoral access. Methods: The randomized multicentre MATRIX (Minimizing Adverse Haemorrhagic Events by TRansradial Access Site and Systemic Implementation of angioX) trial has been designed to compare the clinical outcome of patients with acute coronary syndromes treated invasively according to the access site (transfemoral vs. transradial) and to the anticoagulant therapy (bivalirudin vs. heparin). Selected experienced interventional cardiologists involved in this study have been equipped with dedicated thermoluminescent dosimeters to evaluate the radiation dose absorbed during transfemoral or right transradial or left transradial access. For each access we evaluate the radiation dose absorbed at wrist, at thorax and at eye level. Consequently the operator is equipped with three sets (transfemoral, right transradial or left transradial access) of three different dosimeters (wrist, thorax and eye dosimeter). Primary end-point of the study is the procedural radiation dose absorbed by operators at thorax. An important secondary end-point is the procedural radiation dose absorbed by operators comparing the right or left radial approach. Patient randomization is performed according to the MATRIX protocol for the femoral or radial approach. A further randomization for the radial approach is performed to compare right and left transradial access. Conclusions: The RAD-MATRIX study will probably consent to clarify the radiation issue for interventional cardiologist comparing transradial and transfemoral access in the setting of acute coronary syndromes

  17. Randomized comparison of operator radiation exposure comparing transradial and transfemoral approach for percutaneous coronary procedures: rationale and design of the minimizing adverse haemorrhagic events by TRansradial access site and systemic implementation of angioX – RAdiation Dose study (RAD-MATRIX)

    Sciahbasi, Alessandro, E-mail: alessandro.sciahbasi@fastwebnet.it [Interventional Cardiology, Sandro Pertini Hospital – ASL RMB, Rome (Italy); Calabrò, Paolo [Division of Cardiology - Department of Cardio-Thoracic Sciences - Second University of Naples (Italy); Sarandrea, Alessandro [HSE Management, Rome (Italy); Rigattieri, Stefano [Interventional Cardiology, Sandro Pertini Hospital – ASL RMB, Rome (Italy); Tomassini, Francesco [Department of Cardiology, Infermi Hospital, Rivoli (Italy); Sardella, Gennaro [La Sapienza University, Rome (Italy); Zavalloni, Dennis [UO Emodinamica e Cardiologia Invasiva, IRCCS, Istituto Clinico Humanitas, Rozzano (Italy); Cortese, Bernardo [Interventional Cardiology, Fatebenefratelli Hospital, Milan (Italy); Limbruno, Ugo [Cardiology Unit, Misericordia Hospital, Grosseto (Italy); Tebaldi, Matteo [Cardiology Department, University of Ferrara, Department of Cardiology (Italy); Gagnor, Andrea [Department of Cardiology, Infermi Hospital, Rivoli (Italy); Rubartelli, Paolo [Villa Scassi Hospital, Genova (Italy); Zingarelli, Antonio [San Martino Hospital, Genova (Italy); Valgimigli, Marco [Thoraxcenter, Rotterdam (Netherlands)

    2014-06-15

    Background: Radiation absorbed by interventional cardiologists is a frequently under-evaluated important issue. Aim is to compare radiation dose absorbed by interventional cardiologists during percutaneous coronary procedures for acute coronary syndromes comparing transradial and transfemoral access. Methods: The randomized multicentre MATRIX (Minimizing Adverse Haemorrhagic Events by TRansradial Access Site and Systemic Implementation of angioX) trial has been designed to compare the clinical outcome of patients with acute coronary syndromes treated invasively according to the access site (transfemoral vs. transradial) and to the anticoagulant therapy (bivalirudin vs. heparin). Selected experienced interventional cardiologists involved in this study have been equipped with dedicated thermoluminescent dosimeters to evaluate the radiation dose absorbed during transfemoral or right transradial or left transradial access. For each access we evaluate the radiation dose absorbed at wrist, at thorax and at eye level. Consequently the operator is equipped with three sets (transfemoral, right transradial or left transradial access) of three different dosimeters (wrist, thorax and eye dosimeter). Primary end-point of the study is the procedural radiation dose absorbed by operators at thorax. An important secondary end-point is the procedural radiation dose absorbed by operators comparing the right or left radial approach. Patient randomization is performed according to the MATRIX protocol for the femoral or radial approach. A further randomization for the radial approach is performed to compare right and left transradial access. Conclusions: The RAD-MATRIX study will probably consent to clarify the radiation issue for interventional cardiologist comparing transradial and transfemoral access in the setting of acute coronary syndromes.

  18. The START Study to evaluate the effectiveness of a combination intervention package to enhance antiretroviral therapy uptake and retention during TB treatment among TB/HIV patients in Lesotho: rationale and design of a mixed-methods, cluster-randomized trial

    Howard, Andrea A.; Hirsch-Moverman, Yael; Frederix, Koen; Daftary, Amrita; Saito, Suzue; Gross, Tal; Wu, Yingfeng; Maama, Llang Bridget

    2016-01-01

    Background Initiating antiretroviral therapy (ART) early during tuberculosis (TB) treatment increases survival; however, implementation is suboptimal. Implementation science studies are needed to identify interventions to address this evidence-to-program gap. Objective The Start TB Patients on ART and Retain on Treatment (START) Study is a mixed-methods, cluster-randomized trial aimed at evaluating the effectiveness, cost-effectiveness, and acceptability of a combination intervention package (CIP) to improve early ART initiation, retention, and TB treatment success among TB/HIV patients in Berea District, Lesotho. Design Twelve health facilities were randomized to receive the CIP or standard of care after stratification by facility type (hospital or health center). The CIP includes nurse training and mentorship, using a clinical algorithm; transport reimbursement and health education by village health workers (VHW) for patients and treatment supporters; and adherence support using text messaging and VHW. Routine data were abstracted for all newly registered TB/HIV patients; anticipated sample size was 1,200 individuals. A measurement cohort of TB/HIV patients initiating ART was recruited; the target enrollment was 384 individuals, each to be followed for the duration of TB treatment (6–9 months). Inclusion criteria were HIV-infected; on TB treatment; initiated ART within 2 months of TB treatment initiation; age ≥18; English- or Sesotho-speaking; and capable of informed consent. The exclusion criterion was multidrug-resistant TB. Three groups of key informants were recruited from intervention clinics: early ART initiators; non/late ART initiators; and health care workers. Primary outcomes include ART initiation, retention, and TB treatment success. Secondary outcomes include time to ART initiation, adherence, change in CD4+ count, sputum smear conversion, cost-effectiveness, and acceptability. Follow-up and data abstraction are complete. Discussion The START

  19. The START Study to evaluate the effectiveness of a combination intervention package to enhance antiretroviral therapy uptake and retention during TB treatment among TB/HIV patients in Lesotho: rationale and design of a mixed-methods, cluster-randomized trial

    Andrea A. Howard

    2016-06-01

    Full Text Available Background: Initiating antiretroviral therapy (ART early during tuberculosis (TB treatment increases survival; however, implementation is suboptimal. Implementation science studies are needed to identify interventions to address this evidence-to-program gap. Objective: The Start TB Patients on ART and Retain on Treatment (START Study is a mixed-methods, cluster-randomized trial aimed at evaluating the effectiveness, cost-effectiveness, and acceptability of a combination intervention package (CIP to improve early ART initiation, retention, and TB treatment success among TB/HIV patients in Berea District, Lesotho. Design: Twelve health facilities were randomized to receive the CIP or standard of care after stratification by facility type (hospital or health center. The CIP includes nurse training and mentorship, using a clinical algorithm; transport reimbursement and health education by village health workers (VHW for patients and treatment supporters; and adherence support using text messaging and VHW. Routine data were abstracted for all newly registered TB/HIV patients; anticipated sample size was 1,200 individuals. A measurement cohort of TB/HIV patients initiating ART was recruited; the target enrollment was 384 individuals, each to be followed for the duration of TB treatment (6–9 months. Inclusion criteria were HIV-infected; on TB treatment; initiated ART within 2 months of TB treatment initiation; age ≥18; English- or Sesotho-speaking; and capable of informed consent. The exclusion criterion was multidrug-resistant TB. Three groups of key informants were recruited from intervention clinics: early ART initiators; non/late ART initiators; and health care workers. Primary outcomes include ART initiation, retention, and TB treatment success. Secondary outcomes include time to ART initiation, adherence, change in CD4+ count, sputum smear conversion, cost-effectiveness, and acceptability. Follow-up and data abstraction are complete

  20. Rationale and design of the Transendocardial Injection of Autologous Human Cells (bone marrow or mesenchymal) in Chronic Ischemic Left Ventricular Dysfunction and Heart Failure Secondary to Myocardial Infarction (TAC-HFT) trial: A randomized, double-blind, placebo-controlled study of safety and efficacy.

    Trachtenberg, Barry; Velazquez, Darcy L; Williams, Adam R; McNiece, Ian; Fishman, Joel; Nguyen, Kim; Rouy, Didier; Altman, Peter; Schwarz, Richard; Mendizabal, Adam; Oskouei, Behzad; Byrnes, John; Soto, Victor; Tracy, Melissa; Zambrano, Juan Pablo; Heldman, Alan W; Hare, Joshua M

    2011-03-01

    Although there is tremendous interest in stem cell (SC)-based therapies for cardiomyopathy caused by chronic myocardial infarction, many unanswered questions regarding the best approach remain. The TAC-HFT study is a phase I/II randomized, double-blind, placebo-controlled trial designed to address several of these questions, including the optimal cell type, delivery technique, and population. This trial compares autologous mesenchymal SCs (MSCs) and whole bone marrow mononuclear cells (BMCs). In addition, the study will use a novel helical catheter to deliver cells transendocardially. Although most trials have used intracoronary delivery, the optimal method is unknown and data suggest that the transendocardial approach may have important advantages. Several trials support the benefit of SCs in patients with chronic ischemic cardiomyopathy (ICMP), although the sample sizes have been small and the number of trials sparse. After a pilot phase of 8 patients, 60 patients with ICMP (left ventricular ejection fraction 15%-50%) will be randomized to group A (30 patients further randomized to receive MSC injection or placebo in a 2:1 fashion) or group B (30 patients further randomized to BMCs or placebo in a 2:1 fashion). All patients will undergo bone marrow aspiration and transendocardial injection of SCs or placebo. The primary and secondary objectives are, respectively, to demonstrate the safety and efficacy (determined primarily by cardiac magnetic resonance imaging) of BMCs and MSCs administered transendocardially in patients with ICMP. PMID:21392602

  1. A pragmatic randomised controlled trial on routine iron prophylaxis during pregnancy in Maputo, Mozambique (PROFEG): rationale, design, and success.

    Nwaru, Bright I; Parkkali, Saara; Abacassamo, Fatima; Salomé, Graca; Chilundo, Baltazar; Augusto, Orvalho; Cliff, Julie; Dgedge, Martinho; Regushevskaya, Elena; Nikula, Minna; Hemminki, Elina

    2015-04-01

    The effects of prophylactic iron during pregnancy on maternal and child health in developing settings with endemic malaria and high prevalence of HIV remain unclear. This paper describes the rationale, implementation and success of a pragmatic randomised controlled trial comparing routine iron supplementation vs. screening and treatment for anaemia during pregnancy. The setting was two health centres in Maputo, Mozambique. Pregnant women (≥ 12-week gestation; ≥ 18 years old; and not with a high-risk pregnancy, n=4326) were recruited. The main outcomes are preterm delivery and low birthweight. The women were randomly assigned to one of two iron administration policies: a routine iron group (n=2184) received 60 mg of ferrous sulphate plus 400 μg of folic acid daily while a selective iron group (n=2142) had screening and treatment for anaemia and a daily intake of 1 mg of folic acid. The recruitment, follow-up, and collection of follow-up data were successful; both groups were similar to each other in all the trial stages. Collection of delivery data was challenging and data on about 40% of births is missing. These are currently being traced through different hospitals and health centres. The compliance of the study personnel and the women with regard to regular measurement of haemoglobin and intake of the iron and folic acid tablets was high and similar in both trial arms. Taking into account the various constraints encountered, the stages of the present trial prior to delivery were carried out well. PMID:23020829

  2. A proposed rationale and test methodology for establishment of acceptance criteria for vacuum integrity testing of pharmaceutical freeze dryers.

    Hardwick, Lisa M; Nail, Steven L; Jarman, James; Hasler, Kai; Hense, Thomas

    2013-10-01

    A scientific rationale is proposed for the establishment of acceptance criteria for leak rates in pharmaceutical freeze dryers. A method was developed to determine the quantity of air that could leak into any lyophilizer from the outside while still maintaining Class 100/Grade A microbial conditions. A lyophilizing product is assumed most vulnerable to microbial contamination during secondary drying, when mass transfer of water vapor from product to condenser is minimal. Using the void volume of the dryer, calculated from change in internal pressure when a known volume of air is introduced, and the potential maximum bioburden of the leaked air (based on measured values), calculations can determine the allowable leaked volume of air, the flow rate required to admit that volume in a given time frame, and the pressure rise that would result from the leak over a given testing period. For the dryers in this study, using worst-case air quality conditions, it was determined that a leak resulting in a pressure rise of 0.027 mbar over a 30 min period would allow the dryers to remain in secondary drying conditions for 62 h before the established action level of one colony forming unit for each cubic meter of air space would be reached. PMID:23899644

  3. Economic and Risk Analyses for SMEs Internationalization Projects. A Preliminary Insight on the Rationale of Business Consulting Firms

    Elena - Madalina VĂTĂMĂNESCU

    2014-06-01

    Full Text Available The present study is meant to be a first step towards the investigation of two current issues: the organization’s demand for highly professional services and the business consulting firms’ response as a challenge for the ethic imperatives. The main question raised is whether the national business consulting firms are liable to provide the economic and risk analyses required by the ambitious internationalization projects of small and medium enterprises (SMEs, and if not, what should be the firms’ ethical approach. In this respect, preliminary conclusions were made after testing the deliverables of several business consulting firms which were contracted to elaborate intricate economic and risk analyses of an internationalization project developed by a medium enterprise. The proven level of expertise of the contracted firms did not confirm their claims and assurances that they were fit for the job. This is why the rationale of today’s business consulting firms should be taken into account for further consideration while the exigency for increased savvy should become a priority.

  4. Rationale for a spallation neutron source target system test facility at the 1-MW Long-Pulse Spallation Source

    The conceptual design study for a 1-MW Long-Pulse Spallation Source at the Los Alamos Neutron Science Center has shown the feasibility of including a spallation neutron test facility at a relatively low cost. This document presents a rationale for developing such a test bed. Currently, neutron scattering facilities operate at a maximum power of 0.2 MW. Proposed new designs call for power levels as high as 10 MW, and future transmutation activities may require as much as 200 MW. A test bed will allow assessment of target neutronics; thermal hydraulics; remote handling; mechanical structure; corrosion in aqueous, non-aqueous, liquid metal, and molten salt systems; thermal shock on systems and system components; and materials for target systems. Reliable data in these areas are crucial to the safe and reliable operation of new high-power facilities. These tests will provide data useful not only to spallation neutron sources proposed or under development, but also to other projects in accelerator-driven transmutation technologies such as the production of tritium

  5. Lung VITAL: Rationale, design, and baseline characteristics of an ancillary study evaluating the effects of vitamin D and/or marine omega-3 fatty acid supplements on acute exacerbations of chronic respiratory disease, asthma control, pneumonia and lung function in adults.

    Gold, Diane R; Litonjua, Augusto A; Carey, Vincent J; Manson, JoAnn E; Buring, Julie E; Lee, I-Min; Gordon, David; Walter, Joseph; Friedenberg, Georgina; Hankinson, John L; Copeland, Trisha; Luttmann-Gibson, Heike

    2016-03-01

    Laboratory and observational research studies suggest that vitamin D and marine omega-3 fatty acids may reduce risk for pneumonia, acute exacerbations of respiratory diseases including chronic obstructive lung disease (COPD) or asthma, and decline of lung function, but prevention trials with adequate dosing, adequate power, and adequate time to follow-up are lacking. The ongoing Lung VITAL study is taking advantage of a large clinical trial-the VITamin D and OmegA-3 TriaL (VITAL)-to conduct the first major evaluation of the influences of vitamin D and marine omega-3 fatty acid supplementation on pneumonia risk, respiratory exacerbation episodes, asthma control and lung function in adults. VITAL is a 5-yearU.S.-wide randomized, double-blind, placebo-controlled, 2×2 factorial trial of supplementation with vitamin D3 ([cholecalciferol], 2000IU/day) and marine omega-3 FA (Omacor® fish oil, eicosapentaenoic acid [EPA]+docosahexaenoic acid [DHA], 1g/day) for primary prevention of CVD and cancer among men and women, at baseline aged ≥50 and ≥55, respectively, with 5107 African Americans. In a subset of 1973 participants from 11 urban U.S. centers, lung function is measured before and two years after randomization. Yearly follow-up questionnaires assess incident pneumonia in the entire randomized population, and exacerbations of respiratory disease, asthma control and dyspnea in a subpopulation of 4314 randomized participants enriched, as shown in presentation of baseline characteristics, for respiratory disease, respiratory symptoms, and history of cigarette smoking. Self-reported pneumonia hospitalization will be confirmed by medical record review, and exacerbations will be confirmed by Center for Medicare and Medicaid Services data review. PMID:26784651

  6. Rationale and methods of discovering hormetins as drugs for healthy ageing

    Rattan, Suresh I S

    2012-01-01

    Introduction: Mild stress-induced hormesis is becoming increasingly attractive as an aging interventional strategy, and is leading to the discovery of hormesis-inducing compounds called homretins. This review gives the background, rationale and approaches for screening, testing and developing novel...... hormetins. Areas covered: Almost fifty years of modern biogerontolgical research has established a clear framework regarding the biological basis of aging and longevity, and it is now generally accepted that aging occurs in spite of the presence of complex pathways of maintenance, repair and defence, and...... there is no “enemy within”. This viewpoint makes modulation of aging different from the treatment of one or more age-related diseases. A promising strategy to slow down aging and prevent or delay the onset of age-related diseases is that of mild stress-induced hormesis by using hormetins. Physical...

  7. Tyler’s Curriculum Rationale and the Reconceptualists. Interview with Ralph W. Tyler (1902-1994

    Graciela Cordero Arroyo

    2004-11-01

    Full Text Available Ralph W. Tyler was considered one of the most influential of US educators during the last century. The purpose of this paper is to present an interview granted by Tyler to the first author of this paper in 1990. Tyler’s interview is preceded by a brief analysis of his work, in the hope of shedding light on some misconceptions that Tyler’s work has suffered since early 70s. The present interview may have been the only one given to an Ibero-American academician, and one of the very few in which Tyler spoke openly about what he thought of the fierce criticism launched by reconceptualists against his curriculum rationale.

  8. Rationale and benefits of trimetazidine by acting on cardiac metabolism in heart failure.

    Lopatin, Yuri M; Rosano, Giuseppe M C; Fragasso, Gabriele; Lopaschuk, Gary D; Seferovic, Petar M; Gowdak, Luis Henrique W; Vinereanu, Dragos; Hamid, Magdy Abdel; Jourdain, Patrick; Ponikowski, Piotr

    2016-01-15

    Heart failure is a systemic and multiorgan syndrome with metabolic failure as a fundamental mechanism. As a consequence of its impaired metabolism, other processes are activated in the failing heart, further exacerbating the progression of heart failure. Recent evidence suggests that modulating cardiac energy metabolism by reducing fatty acid oxidation and/or increasing glucose oxidation represents a promising approach to the treatment of patients with heart failure. Clinical trials have demonstrated that the adjunct of trimetazidine to the conventional medical therapy improves symptoms, cardiac function and prognosis in patients with heart failure without exerting negative hemodynamic effects. This review focuses on the rationale and clinical benefits of trimetazidine by acting on cardiac metabolism in heart failure, and aims to draw attention to the readiness of this agent to be included in all the major guidelines dealing with heart failure. PMID:26618252

  9. A rationale plan for conversion of Malaysia for solar hydrogen energy system and its benefits

    It expected that early in the next century, Malaysia production of petroleum and natural gas will peak, and thereafter production will decline. In parallel with this production decline, Malaysia income from fossil fuels will start to decline, which would hurt the economy. One possible solution for Malaysia is the of Malaysia is the conversion to a hydrogen energy system. In order to move towards a sustainable hydrogen energy system, a future strategy must be outlined, followed, and continually revised. This paper will underline the available hydrogen technologies for production, storage, delivery, conversion, transportation and end use energy applications for the implementation of hydrogen energy system. Therefore, this paper will also emphasis the key success factors to drive the rationale plan for conversion to hydrogen energy system for Malaysia

  10. The CfAO's Astronomy Course in COSMOS: Curriculum Design, Rationale, and Application

    Cooksey, Kathy L; Porter, Jason; Raschke, Lynne; Severson, Scott; Hinkley, Sasha

    2010-01-01

    From 2001 to 2007, COSMOS provided a teaching and outreach venue for the Center for Adaptive Optics Professional Development Program (CfAO PDP). COSMOS is a four-week residential mathematics and science summer program for high-school students organized by the University of California on four of its campuses. Two topical science courses comprised each COSMOS cluster. An astronomy course has always formed a basis for the CfAO PDP-affiliated cluster. The course included a variety of pedagogical techniques to address a diversity of learners and goals. We outline the astronomy course---lectures, activities, etc.---and provide the rationale for what was taught, how it was aught, and when it was taught.

  11. 'Letting go': rationale and strategies for student-centred approaches to clinical teaching.

    Rideout, E M

    1994-04-01

    To date the clinical practice portion of nursing education has tended to emphasise patient problems related to specific disease processes and the technical interventions needed to deal with those problems. Teacher-centred methods of education that place control of the process and content of learning with the teacher have seemed appropriate. However, the role and function of nursing is changing. Autonomy, independence and decision-making are more highly valued. In order that nurses develop these skills and abilities, a shift in focus in nursing education is required. This paper presents a rationale for more student-centred approaches to education. Strategies for clinical teaching will be described that emphasise collaboration between student and teacher. Suggestions designed to facilitate change in the roles of teachers and students will be offered. PMID:8177186

  12. Proton therapy for head and neck cancer: Rationale, potential indications, practical considerations, and current clinical evidence

    There is a strong rationale for potential benefits from proton therapy (PT) for selected cancers of the head and neck because of the opportunity to improve the therapeutic ratio by improving radiation dose distributions and because of the significant differences in radiation dose distribution achievable with x-ray-based radiation therapy (RT) and PT. Comparisons of dose distributions between x-ray-based and PT plans in selected cases show specific benefits in dose distribution likely to translate into improved clinical outcomes. However, the use of PT in head and neck cancers requires special considerations in the simulation and treatment planning process, and currently available PT technology may not permit realization of the maximum potential benefits of PT. To date, few clinical data are available, but early clinical experiences in sinonasal tumors in particular suggest significant improvements in both disease control and radiation-related toxicity

  13. Fibroblast growth factor receptor inhibitors as a cancer treatment: from a biologic rationale to medical perspectives.

    Dieci, Maria Vittoria; Arnedos, Monica; Andre, Fabrice; Soria, Jean Charles

    2013-03-01

    The fibroblast growth factor/fibroblast growth factor receptor (FGF/FGFR) signaling pathway plays a fundamental role in many physiologic processes, including embryogenesis, adult tissue homeostasis, and wound healing, by orchestrating angiogenesis. Ligand-independent and ligand-dependent activation have been implicated in a broad range of human malignancies and promote cancer progression in tumors driven by FGF/FGFR oncogenic mutations or amplifications, tumor neoangiogenesis, and targeted treatment resistance, thereby supporting a strong rationale for anti-FGF/FGFR agent development. Efforts are being pursued to develop selective approaches for use against this pathway by optimizing the management of emerging, class-specific toxicity profiles and correctly designing clinical trials to address these different issues. PMID:23418312

  14. Rationale for the Design of a Web-based Programming Course for Adults

    Bennedsen, Jens; Caspersen, Michael Edelgaard

    2003-01-01

    assistant as well as the other students. Another serious drawback is the reduced bandwidth in communication among the different actors. Precautions have to be taken in order to compensate for these and other drawbacks. We describe a web-based introductory programming course for adults and the rationale...... for choosing technologies and organizing the course in order to compensate for the drawbacks inherent in this kind of teaching. Our conclusions, although presented in the context of an introductory programming course, holds for most other construction-based courses as well. In the first part we set the stage...... by describing the relevant context and identifying the special conditions stemming from the course being an introductory programming course. In the second part we present a thorough discussion of the consequences of converting to a webbased course. Based on these consequences, we discuss what is meant...

  15. Rationale for the use of radiolabelled peptides in diagnosis and therapy

    Koopmans, K.P. [Martini Hospital, Department of Radiology and Nuclear Medicine, Groningen (Netherlands); Glaudemans, A.W.J.M. [University of Groningen, Department of Nuclear Medicine and Molecular Imaging, University Medical Center Groningen, Groningen (Netherlands)

    2012-02-15

    Nuclear medicine techniques are becoming more important in imaging oncological and infectious diseases. For metabolic imaging of these diseases, antibody and peptide imaging are currently used. In recent years peptide imaging has become important, therefore the rationale for the use of peptide imaging is described in this article. Criteria for a successful peptide tracer are a high target specificity, a high binding affinity, a long metabolic stability and a high target-to-background ratio. Tracer internalization is also beneficial. For oncological imaging, many tracers are available, most originating from regulatory peptides, but penetrating peptides are also being developed. Peptides for imaging inflammatory and infectious diseases include regulatory peptides, antimicrobial peptides and others. In conclusion, for the imaging of oncological, inflammatory and infectious diseases, many promising peptides are being developed. The ideal peptide probe is characterized by rapid and specific target localization and binding with a high tumour-to-background ratio. (orig.)

  16. Neuroimaging Studies of Factors Related to Exercise: Rationale and design of a 9 month trial

    Herrmann, Stephen D.; Martin, Laura E; Breslin, Florence J.; Honas, Jeffery J.; Willis, Erik A.; Lepping, Rebecca J.; Gibson, Cheryl A; Befort, Christie A; Lambourne, Kate; Burns, Jeffrey M.; Smith, Bryan K.; Sullivan, Debra K.; Washburn, Richard A.; Yeh, Hung-Wen; Donnelly, Joseph E

    2013-01-01

    The prevalence of obesity is high resulting from chronic imbalances between energy intake and expenditure. On the expenditure side, regular exercise is associated with health benefits, including enhanced brain function. The benefits of exercise are not immediate and require persistence to be realized. Brain regions associated with health-related decisions, such as whether or not to exercise or controlling the impulse to engage in immediately rewarding activities (e.g., sedentary behavior), in...

  17. Maximum recovery after knee replacement – the MARKER study rationale and protocol

    Harris Ian

    2009-06-01

    Full Text Available Abstract Background There is little scientific evidence to support the usual practice of providing outpatient rehabilitation to patients undergoing total knee replacement surgery (TKR immediately after discharge from the orthopaedic ward. It is hypothesised that the lack of clinical benefit is due to the low exercise intensity tolerated at this time, with patients still recovering from the effects of major orthopaedic surgery. The aim of the proposed clinical trial is to investigate the clinical and cost effectiveness of a novel rehabilitation strategy, consisting of an initial home exercise programme followed, approximately six weeks later, by higher intensity outpatient exercise classes. Methods/Design In this multicentre randomised controlled trial, 600 patients undergoing primary TKR will be recruited at the orthopaedic pre-admission clinic of 10 large public and private hospitals in Australia. There will be no change to the medical or rehabilitative care usually provided while the participant is admitted to the orthopaedic ward. After TKR, but prior to discharge from the orthopaedic ward, participants will be randomised to either the novel rehabilitation strategy or usual rehabilitative care as provided by the hospital or recommended by the orthopaedic surgeon. Outcomes assessments will be conducted at baseline (pre-admission clinic and at 6 weeks, 6 months and 12 months following randomisation. The primary outcomes will be self-reported knee pain and physical function. Secondary outcomes include quality of life and objective measures of physical performance. Health economic data (health sector and community service utilisation, loss of productivity will be recorded prospectively by participants in a patient diary. This patient cohort will also be followed-up annually for five years for knee pain, physical function and the need or actual incidence of further joint replacement surgery. Discussion The results of this pragmatic clinical trial can be directly implemented into clinical practice. If beneficial, the novel rehabilitation strategy of utilising outpatient exercise classes during a later rehabilitation phase would provide a feasible and potentially cost-effective intervention to optimise the physical well-being of the large number of people undergoing TKR. Trial Registration ACTRN12609000054213

  18. Study rationale and design of the CIMT trial: the Copenhagen Insulin and Metformin Therapy trial

    Lundby Christensen, L; Almdal, T; Boesgaard, T;

    2009-01-01

    combination with one of three insulin analogue regimens, the primary outcome measure being carotid intima-media thickness (CIMT) in T2DM patients. DESIGN: A randomized, stratified, multicentre trial having a 2 x 3 factorial design. The metformin part is double masked and placebo controlled. The insulin...... composition, progression of microvascular complications and quality of life will be assessed as tertiary outcome measures. TIME SCHEDULE: Patient enrolment started May 2008. Follow-up is expected to finish in March 2011. CONCLUSION: CIMT is designed to provide evidence as to whether metformin is advantageous...... even during insulin treatment and to provide evidence regarding which insulin analogue regimen is most advantageous with regard to cardiovascular disease....

  19. Listening to Audiences: A Brief Rationale and History of Audience Research in Popular Media Studies

    Schiappa, Edward; Wessels, Emanuelle

    2007-01-01

    Popular media may be described as television, film, radio, and print media primarily offered for the purpose of entertainment. Such popular media have been the object of critical analysis for decades, both for academic scholars and popular pundits. Our focus is not on quantitative or experimental research concerning popular media effects, but…

  20. Narrative reconstruction therapy for prolonged grief disorder - rationale and case study

    Peri, Tuvia; Hasson-Ohayon, Ilanit; Garber, Sharon; Tuval-Mashiach, Rivka; Paul A Boelen

    2016-01-01

    Background: Prolonged grief disorder (PGD) is a potentially disabling condition affecting approximately 10% of bereaved people. It has been suggested that the impaired integration of the loss memory, as expressed in recurrent memories of the loss and disorganization of memory, is involved in the development of PGD. Narrative reconstruction (NR), originally designed for the treatment of posttraumatic stress disorder (PTSD) in an integrative therapy module, and consisting of exposure to the los...

  1. SOFTWARE FEASIBILITY STUDY TO TRANSFORM COMPLEX SCIENTIFIC WRITTEN KNOWLEDGE TO A CLEAR, RATIONALE AND SIMPLE LANGUAGE

    Manoj Khandelwal

    2015-08-01

    Full Text Available Ali Akbar Dehkhoda, the prominent lexicographer, describes a person who has difficulty in grasping knowledge as someone who “Cannot understand something without knowing all its details.” If the knowledge required by somebody is in a language other than the person’s mother tongue, access to this knowledge will surely meet special difficulties resulting from the person’s lack of mastery over the second language. Any project that can monitor knowledge sources written in English and change them into the user’s language by employing a simple understandable model is capable of being a knowledge-based project with a world view regarding text simplification. This article creates a knowledge system, investigates some algorithms for analyzing contents of complex texts, and presents solutions for changing such texts simple and understandable ones. Texts are automatically analyzed and their ambiguous points are identified by software, but it is the author or the human agent who makes decisions concerning omission of the ambiguities or correction of the texts.

  2. Rationale and design of INTERSTROKE: a global case-control study of risk factors for stroke

    O'Donnell, M; Serpault, Damien Xavier; Diener, C; Sacco, R; Lisheng, L; Zhang, H; Pias, P; Truelsen, T; Chin, S L; Rangarajan, S; Devilliers, L; Damasceno, A; Mondo, C; Lanas, F; Avezum, A; Diaz, Ricardo Gredilla; Varigos, J; Hankey, G; Teal, P; Kapral, M; Ryglewicz, D; Czlonkowska, A; Skowronska, M; Lopez-Jaramillo, P; Dans, T; Langhorne, P; Shah, Sayed Yusuf

    2010-01-01

    age (+/-5 years). A questionnaire (cases and controls) is used to acquire information on known and proposed risk factors for stroke. Cardiovascular (e.g. blood pressure) and anthropometric (e.g. waist-to-hip ratio) measurements are obtained at the time of interview. Nonfasting blood samples and random...

  3. Controversies in the management of vesicoureteral reflux: The rationale for the RIVUR study

    Mathews, Ranjiv; Carpenter, Myra; Chesney, Russell; Hoberman, Alejandro; Keren, Ron; Mattoo, Tej; Moxey-Mims, Marva; Nyberg, Lee; Greenfield, Saul

    2009-01-01

    The current management of vesicoureteral reflux (VUR) focuses on the prevention of urinary tract infections (UTI), with curative surgery being limited to those children that fail conservative measures. This is based on the assumption that UTIs are preventable with the use of prophylatic antibiotics, leading to reduction of renal scarring, and the possibility that VUR in children can resolve spontaneously.

  4. Evaluation of a standard provision versus an autonomy promotive exercise referral programme: rationale and study design

    Jolly Kate; Duda Joan L; Daley Amanda; Eves Frank F; Mutrie Nanette; Ntoumanis Nikos; Rouse Peter C; Lodhia Rekha; Williams Geoffrey C

    2009-01-01

    Abstract Background The National Institute of Clinical Excellence in the UK has recommended that the effectiveness of ongoing exercise referral schemes to promote physical activity should be examined in research trials. Recent empirical evidence in health care and physical activity promotion contexts provides a foundation for testing the utility of a Self Determination Theory (SDT)-based exercise referral consultation. Methods/Design Design: An exploratory cluster randomised controlled trial ...

  5. Critical review of norovirus surrogates in food safety research: rationale for considering volunteer studies

    The inability to propagate human norovirus (NoV) or to clearly differentiate infectious from noninfectious virus particles have led to the use of surrogate viruses, like feline calicivirus (FCV) and murine norovirus-1 (MNV), which are propagatable in cell culture. The use of surrogates is predicate...

  6. The role of Amazonian anthropogenic soils in shifting cultivation: learning from farmers' rationales

    André B. Junqueira

    2016-03-01

    Full Text Available We evaluated farmers' rationales to understand their decision making in relation to the use of fertile anthropogenic soils, i.e., Amazonian dark earths (ADE, and for dealing with changes in shifting cultivation in Central Amazonia. We analyzed qualitative information from 196 interviews with farmers in 21 riverine villages along the Madeira River. In order to decide about crop management options to attain their livelihood objectives, farmers rely on an integrated and dynamic understanding of their biophysical and social environment. Farmers associate fallow development with higher crop yields and lower weed pressure, but ADE is always associated with high yields and high weeding requirements. Amazonian dark earths are also seen as an opportunity to grow different crops and/or grow crops in more intensified management systems. However, farmers often maintain simultaneously intensive swiddens on ADE and extensive swiddens on nonanthropogenic soils. Farmers acknowledge numerous changes in their socioeconomic environment that affect their shifting cultivation systems, particularly their growing interaction with market economies and the incorporation of modern agricultural practices. Farmers considered that shifting cultivation systems on ADE tend to be more prone to changes leading to intensification, and we identified cases, e.g., swiddens used for watermelon cultivation, in which market demand led to overintensification and resulted in ADE degradation. This shows that increasing intensification can be a potential threat to ADE and can undermine the importance of these soils for agricultural production, for the conservation of agrobiodiversity, and for local livelihoods. Given that farmers have an integrated knowledge of their context and respond to socioeconomic and agro-ecological changes in their environment, we argue that understanding farmers' knowledge and rationales is crucial to identify sustainable pathways for the future of ADE and of

  7. Targeted therapies for non-small-cell lung cancer: biology, rationale, and preclinical results from a radiation oncology perspective

    The epidermal growth factor receptor (EGFR) is overexpressed in the majority of non-small-cell lung cancers (NSCLCs). This presents an opportune target for new treatment strategies designed to selectively interfere with the cancer cell growth cycle. Recent investigations into the biology of the EGFR and its downstream signaling pathways have reminded us of the complexity of cancer cell communications from the cytoplasm to the nucleus. Multiple pathways are activated with stimulation of the autocrine and paracrine EGFR loop, from the ras-raf-MEK activation of ERK 1/2 to the P13K-Akt pathway, each playing an important role in cancer cell survival, invasion, and angiogenesis. Preclinical studies have demonstrated that molecules targeting the EGFR, either through extracellular blockade or intracellular interference with the EGFR-associated tyrosine kinase, reversibly or irreversibly, inhibit cancer cell growth. Potent antitumor effects have been observed in human tumor xenograft models. Preclinical studies have also demonstrated cooperative effects when anti-EGFR agents are combined with radiation or chemotherapy. Many of these agents have now entered into advanced human clinical trials with modest dose-related toxicity despite chronic administration. Encouraging response rates with single-agent targeted therapy have been reported in heavily pretreated patients with advanced NSCLC. In addition, agents targeting the angiogenic pathway, which plays a key role in the regulation of angiogenesis, may play an important role in enhancing the efficacy of anti-EGFR agents. This article will focus on the biology, rationale, and preclinical studies with targeted anti-EGFR and antiangiogenic therapies for the management of NSCLC

  8. Rationale and clinical utility of the darunavir-cobicistat combination in the treatment of HIV/AIDS.

    Putcharoen, Opass; Do, Tanya; Avihingsanon, Anchalee; Ruxrungtham, Kiat

    2015-01-01

    This article is to provide an update overview of cobicistat (COBI)-boosted darunavir in response to its recent approval by the US Food and Drug Administration, and inclusion as an alternative first-line regime in the 2015 treatment guidelines in the US. COBI is a relatively new non-antiretroviral cytochrome P450 3A inhibitor or pharmacoenhancer. The rationale behind COBI development was to provide an alternative to ritonavir (RTV) as a protease inhibitor pharmacoenhancer, due to associated adverse events with short- and long-term RTV use, such as gastrointestinal intolerability, drug-drug interactions, insulin resistance, lipodystrophy, and hyperlipidemia. Although in vitro studies suggest that COBI may result in a lower incidence of undesired drug-drug interactions and lipid-associated disorders than RTV, not all Phase III studies have well addressed these issues, and the data are limited. However, Phase III studies have demonstrated tolerability, noninferiority, and bioequivalence of COBI compared to RTV. Two main advantages of COBI over RTV-containing regimes have been noted as follows: 1) COBI has no anti-HIV activity; therefore, resistance to COBI as a booster in addition to protease inhibitor resistance is of little concern, allowing for COBI-containing regimes in future. 2) COBI's solubility and dissolution rate allow for co-formulated/fixed-dose combination products. Nonetheless, prior to initiating COBI-containing treatment regimens, the following should be considered: 1) COBI may increase serum creatinine levels and reduce estimated glomerular filtration rate (GFR) without affecting actual GFR; 2) potential drug-drug interaction data are insufficient, warranting caution when initiating COBI in conjunction with concomitant medication or in individuals with multiple comorbidities; 3) food plays a pivotal role in boosting darunavir exposure, warranting caution and patient education on the importance of taking COBI-containing regimens with appropriate amounts

  9. Targeting the PD1/PD-L1 axis in melanoma: Biological rationale, clinical challenges and opportunities

    Barbara Merelli; Daniela Massi; Laura Cattaneo; Mario Mandalà

    2014-01-01

    In this review we summarize the biological role of PD-1/PD-L1 on cancer by focusing our attention in the biological rationale, clinical challenges and opportunities to target the PD-1/PD-L1 axis in melanoma.

  10. Rationale and Specifications for a Prototype, Group-Administered End-of-Unit Assessment Instrument for the SWRL Reading Program.

    Okada, Masahito; Besel, Ronald

    This document describes the purposes, rationale, and specifications of a prototype group-administered criterion exercise to be used with blocks 1-8 of the Southwest Regional Laboratory (SWRL) Reading Program. A description of the sampling domains, sampling procedures, and the methods employed in the construction of test items is presented. Also…

  11. The Rationale for Subsidy of Higher Education in Hong Kong: A Sensible Decision from an Economic Viewpoint

    Chan, Shing Yin Amy

    2010-01-01

    This paper is an attempt to draw the statistical data from reports and documents to reveal the rationale for subsidizing the higher education in Hong Kong. There is a discussion made with reference to educational planning interacting with personal choice. The notion of economics has been noted with consideration of allocation of scarce resources…

  12. Subsidizing Early Childhood Education and Care for Parents on Low Income: Moving beyond the Individualized Economic Rationale of Neoliberalism

    Simpson, Donald; Envy, Rose

    2015-01-01

    Neoliberalism and an associated "new politics of parenting" adopts a predominantly economic rationale which discursively positions early childhood education and care (ECEC) as essential to tackling several social ills by allowing individual parents (particularly young mothers) to improve their labour force participation, thus boosting…

  13. A randomized controlled trial to evaluate self-determination theory for exercise adherence and weight control: rationale and intervention description

    Matos Margarida G

    2008-07-01

    Full Text Available Abstract Background Research on the motivational model proposed by Self-Determination Theory (SDT provides theoretically sound insights into reasons why people adopt and maintain exercise and other health behaviors, and allows for a meaningful analysis of the motivational processes involved in behavioral self-regulation. Although obesity is notoriously difficult to reverse and its recidivism is high, adopting and maintaining a physically active lifestyle is arguably the most effective strategy to counteract it in the long-term. The purposes of this study are twofold: i to describe a 3-year randomized controlled trial (RCT aimed at testing a novel obesity treatment program based on SDT, and ii to present the rationale behind SDT's utility in facilitating and explaining health behavior change, especially physical activity/exercise, during obesity treatment. Methods Study design, recruitment, inclusion criteria, measurements, and a detailed description of the intervention (general format, goals for the participants, intervention curriculum, and main SDT strategies are presented. The intervention consists of a 1-year group behavioral program for overweight and moderately obese women, aged 25 to 50 (and pre-menopausal, recruited from the community at large through media advertisement. Participants in the intervention group meet weekly or bi-weekly with a multidisciplinary intervention team (30 2 h sessions in total, and go through a program covering most topics considered critical for successful weight control. These topics and especially their delivery were adapted to comply with SDT and Motivational Interviewing guidelines. Comparison group receive a general health education curriculum. After the program, all subjects are follow-up for a period of 2 years. Discussion Results from this RCT will contribute to a better understanding of how motivational characteristics, particularly those related to physical activity/exercise behavioral self

  14. Diffusion of school-based prevention programs in two urban districts: adaptations, rationales, and suggestions for change.

    Ozer, Emily J; Wanis, Maggie G; Bazell, Nickie

    2010-03-01

    The diffusion of school-based preventive interventions involves the balancing of high-fidelity implementation of empirically-supported programs with flexibility to permit local stakeholders to target the specific needs of their youth. There has been little systematic research that directly seeks to integrate research- and community-driven approaches to diffusion. The present study provides a primarily qualitative investigation of the initial roll-out of two empirically-supported substance and violence prevention programs in two urban school districts that serve a high proportion of low-income, ethnic minority youth. The predominant ethnic group in most of our study schools was Asian American, followed by smaller numbers of Latinos, African Americans, and European Americans. We examined the adaptations made by experienced health teachers as they implemented the programs, the elicitation of suggested adaptations to the curricula from student and teacher stakeholders, and the evaluation of the consistency of these suggested adaptations with the core components of the programs. Data sources include extensive classroom observations of curricula delivery and interviews with students, teachers, and program developers. All health teachers made adaptations, primarily with respect to instructional format, integration of real-life experiences into the curriculum, and supplementation with additional resources; pedagogical and class management issues were cited as the rationale for these changes. Students and teachers were equally likely to propose adaptations that met with the program developers' approval with respect to program theory and implementation logistics. Tensions between teaching practice and prevention science-as well as implications for future research and practice in school-based prevention-are considered. PMID:19697133

  15. Oral Contraceptive Pills: Combinations, Dosages and the Rationale behind 50 Years or Oral Hormonal Contraceptive Development

    Rabe T

    2011-01-01

    symptoms, but also to find new compounds and formulas intended to replace those at the end of their patent lifespan. Methods of Good Clinical Practice have been established and large-scale epidemiological studies initiated (i.e. Study of the Royal College of General Practitioners, 1974 [566]. Several general approaches to OC development can be followed. Synthetic or natural estrogens provide a reliable cycle control and prevent estrogen deficiency symptoms due to the decreased secretion of endogenous estrogen from growth follicles. More selective, highly specific progestins have been developed with pharmacological properties similar to natural progesterone, some with antiandrogenic properties and suitable for transvaginal, transdermal, subdermal or intrauterine application. Furthermore, these new progestins produce fewer undesired effects on the breast and other reproductive organs and exhibit low carcinogenicity. Various additives have been tested for their additional non-contraceptive benefits (i.e. iron, folate, DHEA either by preventing certain undesired side effects of estrogens and progestins or by improving the general health status. Combinations of estrogen and progestin have evolved from monophasic to multiphasic formulations. Combination products require lower doses of steroids and provide a clinical profile similar to the normal menstrual cycle. New regimens (21 + 7, 22 + 6, 24 + 4, 84 + 7 with and without placebo pills or continuous administration have been used to maintain the contraceptive efficacy of the higher dose products and to achieve a stable bleeding pattern at lower doses. To date only Ortho-McNeil, Bayer HealthCare, MSD and Pfizer have been able to afford scientific research in the field of contraception and develop new products. The loss of patent lawsuits on their part, however, has allowed for the production of generic alternatives of oral contraceptives by other companies thus making it difficult for them to continue research in this specific

  16. The rationale behind small food store interventions in low-income urban neighborhoods: insights from New Orleans.

    Bodor, J Nicholas; Ulmer, Vanessa M; Dunaway, Lauren Futrell; Farley, Thomas A; Rose, Donald

    2010-06-01

    Environmental approaches to the obesity problem in the US have garnered favor due to growing evidence that changes to the environment are at the root of the epidemic. Low-income urban neighborhoods, where obesity rates are disproportionately high, typically lack supermarkets yet have a high density of small food stores. This may increase the risk for unhealthy diets and obesity for neighborhood residents, because small stores carry mostly energy-dense foods and few fruits and vegetables. This paper pulls together various studies and pilot work conducted in New Orleans to explore the rationale behind small store interventions. Many low-income residents in New Orleans live within walking distance of small food stores and shop at them frequently. Marketing research has documented that changes to in-store shelf space and displays of specific foods affect the sales of these foods. Initiatives in New Orleans and elsewhere have demonstrated some success with improving healthy food availability in small stores, and an intercept survey of customers at small stores suggests that customers would purchase more fruits and vegetables if available. Efforts to encourage small store operators to offer a healthier mix of foods may, in the end, depend on the profitability of such changes. Evidence from a typical small store in New Orleans indicates that a greater percentage of gross profits come from snack foods and beverages than from fruits and vegetables. More research is needed to better understand the financial operations of small food stores and whether altering the mix of foods is economically feasible. PMID:20410086

  17. The Danish Alzheimer intervention study

    Waldemar, G; Waldorff, F B; Buss, D V;

    2011-01-01

    Background: There is a lack of appropriately designed trials investigating the efficacy of psychosocial interventions for patients with mild dementia and their family caregivers. This paper reports the rationale and design of the Danish Alzheimer Disease Intervention Study and baseline characteri......Background: There is a lack of appropriately designed trials investigating the efficacy of psychosocial interventions for patients with mild dementia and their family caregivers. This paper reports the rationale and design of the Danish Alzheimer Disease Intervention Study and baseline...

  18. A randomized controlled trial investigation of a non-stimulant in attention deficit hyperactivity disorder (ACTION: Rationale and design

    Clarke Simon D

    2011-03-01

    Full Text Available Abstract Background The ACTION study (Attention deficit hyperactivity disorder Controlled Trial Investigation Of a Non-stimulant is a multi-center, double-blind, randomized cross-over trial of the non-stimulant medication, Atomoxetine, in children and adolescents with attention deficit hyperactivity disorder (ADHD. The primary aims are to examine the efficacy of atomoxetine for improving cognition and emotional function in ADHD and whether any improvements in these outcomes are more pronounced in participants with comorbid anxiety; and to determine if changes in these outcomes after atomoxetine are more reliable than changes in diagnostic symptoms of ADHD. This manuscript will describe the methodology and rationale for the ACTION study. Methods Children and adolescents aged 6 - 17 y with ADHD will be enrolled. Clinical interview and validated scales will be used to confirm diagnosis and screen for exclusion criteria, which include concurrent stimulant use, and comorbid psychiatric or neurological conditions other than anxiety. Three assessment sessions will be conducted over the 13-week study period: Session 1 (Baseline, pre-treatment, Session 2 (six weeks, atomoxetine or placebo, and Session 3 (13 weeks, cross-over after one-week washout period. The standardized touch-screen battery, "IntegNeuro™", will be used to assess cognitive and emotional function. The primary measure of response will be symptom ratings, while quality of life will be a secondary outcome. Logistic regression will be used to determine predictors of treatment response, while repeated measures of analysis will determine any differences in effect of atomoxetine and placebo. Results The methodology for the ACTION study has been detailed. Conclusions The ACTION study is the first controlled trial to investigate the efficacy of atomoxetine using objective cognitive and emotional function markers, and whether these objective measures predict outcomes with atomoxetine in ADHD

  19. Point: The rationale for universal lipid screening and treatment in children.

    Benuck, Irwin

    2015-01-01

    Screening a healthy population for future harmful diseases has the potential of reducing the risk of later morbidity and mortality with early identification and intervention. However, it is important that the screening meets acceptable standards, and the benefits of the screening outweigh risks. The recently published "Expert Panel on Integrated Guidelines for Cardiovascular Health and Risk Reduction in Children and Adolescents" (National Heart Lung Blood Institute Guidelines) carefully examined the multiple risk factors for coronary artery disease that begins in childhood but may not become problematic until years later. The evidence-based guidelines give many recommendations that are focused on identification, prevention, and intervention. Included in the guidelines are useful suggestions for improving lifestyle and food choices. In the section on lipids and lipoprotein, careful consideration was given to universal screening of children between 9 and 11 years of age with no known cardiac risk factors and again, if needed, between 17 and 21 years of age. Children with cardiac risk factors may be screened earlier. The section continues with rationale for medical management of children who are refractory to other interventions. The purpose of this article is to discuss the benefits of screening for dyslipidemia in the pediatric population and when necessary, medical management to reduce the risk for coronary artery disease. Both universal screening and early intervention in the pediatric population will identify individuals not previously recognized at risk for premature coronary artery disease and stroke and reduce the incidence of later morbidity and mortality. PMID:26343217

  20. Mindfulness-based stress reduction for veterans exposed to military sexual trauma: rationale and implementation considerations.

    Gallegos, Autumn M; Cross, Wendi; Pigeon, Wilfred R

    2015-06-01

    Military sexual trauma (MST) represents a significant public health concern among military personnel and Veterans and is associated with considerable morbidity and suicide risk. It is estimated that 22% of Veteran women and 1% of Veteran men experienced sexual assault or repeated, threatening sexual harassment during their military service. Exposure to traumatic stress has detrimental effects on emotion regulation, which refers to a set of strategies used to modulate different components of emotion at different points on the trajectory of an emotional response. Mindfulness-based interventions offer approaches to health that focus on mind and body practices that can help regulate the experience and expression of difficult emotions. Mindfulness-based stress reduction (MBSR) is an evidence-based therapy shown to be effective for depression, anxiety, and post-traumatic stress disorder. This article discusses the rationale for providing MBSR to Veterans who have been exposed to MST. The article also discusses ways to facilitate implementation of this practice in the U.S. Department of Veterans Affairs health care system. We address potential barriers to care and ways to facilitate implementation at the patient, provider, organization/local, and policy levels. MBSR is likely to be an important component of a comprehensive approach to care for Veterans exposed to MST. PMID:26032384

  1. The rationale for simple approaches for sustainability assessment and management in contaminated land practice.

    Bardos, R Paul; Bone, Brian D; Boyle, Richard; Evans, Frank; Harries, Nicola D; Howard, Trevor; Smith, Jonathan W N

    2016-09-01

    The scale of land-contamination problems, and of the responses to them, makes achieving sustainability in contaminated land remediation an important objective. The Sustainable Remediation Forum in the UK (SuRF-UK) was established in 2007 to support more sustainable remediation practice in the UK. The current international interest in 'sustainable remediation' has achieved a fairly rapid consensus on concepts, descriptions and definitions for sustainable remediation, which are now being incorporated into an ISO standard. However the sustainability assessment methods being used remain diverse with a range of (mainly) semi-quantitative and quantitative approaches and tools developed, or in development. Sustainability assessment is site specific and subjective. It depends on the inclusion of a wide range of considerations across different stakeholder perspectives. Taking a tiered approach to sustainability assessment offers important advantages, starting from a qualitative assessment and moving through to semi-quantitative and quantitative assessments on an 'as required' basis only. It is also clear that there are a number of 'easy wins' that could improve performance against sustainability criteria right across the site management process. SuRF-UK has provided a checklist of 'sustainable management practices' that describes some of these. This paper provides the rationale for, and an outline of, and recently published SuRF-UK guidance on preparing for and framing sustainability assessments; carrying out qualitative sustainability assessment; and simple good management practices to improve sustainability across contaminated land management activities. PMID:26765509

  2. Analysis and evaluation of the rationales for single-sex schooling.

    Bigler, Rebecca S; Hayes, Amy Roberson; Liben, Lynn S

    2014-01-01

    Amendments passed as part of the No Child Left Behind Act in 2006 made some forms of single-sex (SS) public education legal in the United States. Proponents offer a host of arguments in favor of such schooling. This chapter identifies and evaluates five broad rationales for SS schooling. We conclude that empirical evidence fails to support proponents' claims but nonetheless suggests ways in which to improve coeducation. Specifically, we (a) show that the purported benefits of SS schooling arise from factors confounded with, but not causally linked to, single-sex composition; (b) challenge claims that biological sex is an effective marker of differences relevant to instruction; (c) argue that sexism on the part of teachers and peers persists in SS contexts; and (d) critique the notion that gender per se "disappears" in SS contexts. We also address societal implications of the use of sex-segregated education and conclude that factors found to be beneficial for students should be implemented within coeducational schools. PMID:25344998

  3. Rationale for the Use of CAD/CAM Technology in Implant Prosthodontics

    Abduo, Jaafar; Lyons, Karl

    2013-01-01

    Despite the predictable longevity of implant prosthesis, there is an ongoing interest to continue to improve implant prosthodontic treatment and outcomes. One of the developments is the application of computer-aided design and computer-aided manufacturing (CAD/CAM) to produce implant abutments and frameworks from metal or ceramic materials. The aim of this narrative review is to critically evaluate the rationale of CAD/CAM utilization for implant prosthodontics. To date, CAD/CAM allows simplified production of precise and durable implant components. The precision of fit has been proven in several laboratory experiments and has been attributed to the design of implants. Milling also facilitates component fabrication from durable and aesthetic materials. With further development, it is expected that the CAD/CAM protocol will be further simplified. Although compelling clinical evidence supporting the superiority of CAD/CAM implant restorations is still lacking, it is envisioned that CAD/CAM may become the main stream for implant component fabrication. PMID:23690778

  4. Rationale for the Use of CAD/CAM Technology in Implant Prosthodontics

    Jaafar Abduo

    2013-01-01

    Full Text Available Despite the predictable longevity of implant prosthesis, there is an ongoing interest to continue to improve implant prosthodontic treatment and outcomes. One of the developments is the application of computer-aided design and computer-aided manufacturing (CAD/CAM to produce implant abutments and frameworks from metal or ceramic materials. The aim of this narrative review is to critically evaluate the rationale of CAD/CAM utilization for implant prosthodontics. To date, CAD/CAM allows simplified production of precise and durable implant components. The precision of fit has been proven in several laboratory experiments and has been attributed to the design of implants. Milling also facilitates component fabrication from durable and aesthetic materials. With further development, it is expected that the CAD/CAM protocol will be further simplified. Although compelling clinical evidence supporting the superiority of CAD/CAM implant restorations is still lacking, it is envisioned that CAD/CAM may become the main stream for implant component fabrication.

  5. Rationale for Flexible Path - A Space Exploration Strategy for the 21st Century

    Schmidt, G. R.; Landis, G. A.; Oleson, S. R.

    In 2009, the U.S. President convened a special committee to recommend directions for the U.S. human spaceflight program. One preferred option - the “Flexible Path” strategy - differs markedly from the Moon and Mars-oriented paradigm that has driven U.S. planning in the past. Specifically, it refrains from placing humans on the surfaces of these planetary bodies in the near-term, and instead focuses on sending piloted spacecraft into orbit around exploration targets of interest, and conducting astronaut exploration of the surfaces using telerobots and remotely controlled systems. Teleoperation provides scientists real- time control of rovers and other sophisticated instruments, thus expanding the scientific return at these destinations. It also eliminates development of the numerous man-rated landers, ascent vehicles and systems required to sustain humans on planetary surfaces. The propulsive requirements to travel from Low Earth Orbit (LEO) to many destinations with shallow gravity-wells in the inner solar system are quite similar. Thus, a common set of spacecraft elements (e.g., launch vehicles, upper stage/transfer vehicle, crew module/habitat) could be used to perform a variety of different missions, including orbit- based surface exploration of the Moon, Mars and Venus, and rendezvous with Near Earth Asteroids (NEAs), as well as Phobos and Deimos. This paper presents the rationale for Flexible Path, and explains why it should be the strategy for human space exploration in the 21st Century.

  6. NESC Peer-Review of the Flight Rationale for Expected Debris Report. Version 1.0

    Harris, Charles E.; Raju, Ivatury S.; Stadler, John H.; Piascik, Robert S.; Kramer-White, Julie A.; Labbe, Steve G.; Ungar, Eugene K.; Rotter, Hank A.; Rogers, James H.; Null, Cynthia H.

    2005-01-01

    Since the loss of Columbia on February 1, 2003, the Space Shuttle Program (SSP) has significantly improved the understanding of launch and ascent debris, implemented hardware modifications to reduce debris, and conducted tests and analyses to understand the risks associated with expected debris. The STS-114 flight rationale for expected debris relies on a combination of all three of these factors. A number of design improvements have been implemented to reduce debris at the source. The External Tank (ET) thermal protection system (TPS) foam has been redesigned and/or process improvements have been implemented in the following locations: the bipod closeout, the first ten feet of the liquid hydrogen (LH2) tank protuberance air load (PAL) ramp, and the LH2 tank-to-intertank flange closeout. In addition, the forward bipod ramp has been eliminated and heaters have been installed on the bipod fittings and the liquid oxygen (LO2) feedline forward bellows to prevent ice formation. The Solid Rocket Booster (SRB) bolt catcher has been redesigned. The Orbiter reaction control system (RCS) thruster cover "butcher paper" has been replaced with a material that sheds at a low velocity. Finally, the pad area has been cleaned to reduce debris during lift-off.

  7. The Rationale for a Teaching Innovation About the Interrelationship Between Science and Technology

    Hadjilouca, R.; Constantinou, C. P.; Papadouris, N.

    2011-10-01

    This paper refers to the development of a teaching innovation for the nature of science (NOS), for students aged 11-15, which specifically focuses on the interrelationship between science and technology. The development of the teaching and learning materials relied on inputs from three sources: the history and philosophy of science and technology, existing knowledge concerning the teaching and learning about the NOS, empirical data on students' initial ideas and difficulties about this topic. The first served to provide an account for the various forms of interaction between science and technology, which, in turn, guided the formulation of epistemologically coherent learning objectives. The second provided the pedagogical grounds on which to base the design of the activities. The third facilitated the design of activities that build on students' productive initial ideas, while providing them with guidance to resolve the difficulties they tend to encounter. In this paper, we describe the rationale underlying the teaching and learning materials and we describe the activity sequence they embody.

  8. Holonic Rationale and Bio-inspiration on Design of Complex Emergent and Evolvable Systems

    Leitao, Paulo

    Traditional centralized and rigid control structures are becoming inflexible to face the requirements of reconfigurability, responsiveness and robustness, imposed by customer demands in the current global economy. The Holonic Manufacturing Systems (HMS) paradigm, which was pointed out as a suitable solution to face these requirements, translates the concepts inherited from social organizations and biology to the manufacturing world. It offers an alternative way of designing adaptive systems where the traditional centralized control is replaced by decentralization over distributed and autonomous entities organized in hierarchical structures formed by intermediate stable forms. In spite of its enormous potential, methods regarding the self-adaptation and self-organization of complex systems are still missing. This paper discusses how the insights from biology in connection with new fields of computer science can be useful to enhance the holonic design aiming to achieve more self-adaptive and evolvable systems. Special attention is devoted to the discussion of emergent behavior and self-organization concepts, and the way they can be combined with the holonic rationale.

  9. Money Laundering, Corruption and Growth: An Empirical Rationale for a Global Convergence on Anti-Money Laundering Regulation

    Cavalcante Veiga, Luiz Humberto; de Andrade, Joaquim Pinto

    2006-01-01

    This paper provides empirical evidence on the impact of anti-money laundering regulations on growth and, it examines the rationale for a global adoption of these rules. The empirical results have led us to confirm a positive relation between low corruption levels and high investment and growth. We approached the impact on growth of money laundering prevention (MLP) initiatives in two ways: first, by verifying that the existence of these initiatives affects the perception of corruption. Second...

  10. High dose rate prostate brachytherapy: an overview of the rationale, experience and emerging applications in the treatment of prostate cancer

    Challapalli, A; Jones, E; C Harvey; Hellawell, G O; Mangar, S A

    2012-01-01

    The technological advances in real-time ultrasound image guidance for high dose rate (HDR) prostate brachytherapy places this treatment modality at the forefront of innovation in radiotherapy. This review article will explore the rationale for HDR brachytherapy as a highly conformal method of dose delivery and safe dose escalation to the prostate, in addition to the particular radiobiological advantages it has over low dose rate and external beam radiotherapy. The encouraging outcome data and...

  11. Mesopancreas: A boundless structure, namely the rationale for dissection of the paraaortic area in pancreaticoduodenectomy for pancreatic head carcinoma

    Peparini, Nadia

    2015-01-01

    This review highlights the rationale for dissection of the 16a2 and 16b1 paraaortic area during pancreaticoduodenectomy (PD) for carcinoma of the head of the pancreas. Recent advances in surgical anatomy of the mesopancreas indicate that the retropancreatic area is not a single entity with well defined boundaries but an anatomical site of embryological fusion of peritoneal layers, and that continuity exists between the neuro lymphovascular adipose tissues of the retropancreatic and paraaortic...

  12. Are PTSD Treatment Choices and Treatment Beliefs Related to Depression Symptoms and Depression-Relevant Treatment Rationales?

    Rytwinski, Nina K; Rosoff, Cari B.; Feeny, Norah C.; Zoellner, Lori A.

    2014-01-01

    Given high rates of depression and low rates of treatment utilization among individuals with posttraumatic stress disorder (PTSD), we examined how depression symptoms impact PTSD treatment beliefs and preference (prolonged exposure (PE), sertraline, or PE plus sertraline). We also examined whether PTSD treatment rationales tailored to individuals with symptoms of depression impact PTSD treatment preference/beliefs. Undergraduates (N = 439) were given an “imagine self” scenario where they eith...

  13. Rationale and clinical utility of the darunavir–cobicistat combination in the treatment of HIV/AIDS

    Putcharoen O

    2015-10-01

    Full Text Available Opass Putcharoen,1 Tanya Do,2 Anchalee Avihingsanon,2 Kiat Ruxrungtham1,2 1Department of Medicine, Faculty of Medicine, Chulalongkorn University, 2The HIV Netherlands Australia Thailand (HIV-NAT Research Collaboration, The Thai Red Cross AIDS Research Center, Bangkok, Thailand Abstract: This article is to provide an update overview of cobicistat (COBI-boosted darunavir in response to its recent approval by the US Food and Drug Administration, and inclusion as an alternative first-line regime in the 2015 treatment guidelines in the US. COBI is a relatively new non-antiretroviral cytochrome P450 3A inhibitor or pharmacoenhancer. The rationale behind COBI development was to provide an alternative to ritonavir (RTV as a protease inhibitor pharmacoenhancer, due to associated adverse events with short- and long-term RTV use, such as gastrointestinal intolerability, drug–drug interactions, insulin resistance, lipodystrophy, and hyperlipidemia. Although in vitro studies suggest that COBI may result in a lower incidence of undesired drug–drug interactions and lipid-associated disorders than RTV, not all Phase III studies have well addressed these issues, and the data are limited. However, Phase III studies have demonstrated tolerability, noninferiority, and bioequivalence of COBI compared to RTV. Two main advantages of COBI over RTV-containing regimes have been noted as follows: 1 COBI has no anti-HIV activity; therefore, resistance to COBI as a booster in addition to protease inhibitor resistance is of little concern, allowing for COBI-containing regimes in future. 2 COBI’s solubility and dissolution rate allow for co-formulated/fixed-dose combination products. Nonetheless, prior to initiating COBI-containing treatment regimens, the following should be considered: 1 COBI may increase serum creatinine levels and reduce estimated glomerular filtration rate (GFR without affecting actual GFR; 2 potential drug–drug interaction data are insufficient

  14. The Survey of the Health of Wisconsin (SHOW, a novel infrastructure for population health research: rationale and methods

    Friedman Elliot M

    2010-12-01

    Full Text Available Abstract Background Evidence-based public health requires the existence of reliable information systems for priority setting and evaluation of interventions. Existing data systems in the United States are either too crude (e.g., vital statistics, rely on administrative data (e.g., Medicare or, because of their national scope (e.g., NHANES, lack the discriminatory power to assess specific needs and to evaluate community health activities at the state and local level. This manuscript describes the rationale and methods of the Survey of the Health of Wisconsin (SHOW, a novel infrastructure for population health research. Methods/Design The program consists of a series of independent annual surveys gathering health-related data on representative samples of state residents and communities. Two-stage cluster sampling is used to select households and recruit approximately 800-1,000 adult participants (21-74 years old each year. Recruitment and initial interviews are done at the household; additional interviews and physical exams are conducted at permanent or mobile examination centers. Individual survey data include physical, mental, and oral health history, health literacy, demographics, behavioral, lifestyle, occupational, and household characteristics as well as health care access and utilization. The physical exam includes blood pressure, anthropometry, bioimpedance, spirometry, urine collection and blood draws. Serum, plasma, and buffy coats (for DNA extraction are stored in a biorepository for future studies. Every household is geocoded for linkage with existing contextual data including community level measures of the social and physical environment; local neighborhood characteristics are also recorded using an audit tool. Participants are re-contacted bi-annually by phone for health history updates. Discussion SHOW generates data to assess health disparities across state communities as well as trends on prevalence of health outcomes and

  15. Expression of histamine receptors in the human endolymphatic sac: the molecular rationale for betahistine use in Menieres disease.

    Møller, M Nue; Kirkeby, S; Vikeså, J; Nielsen, F Cilius; Caye-Thomasen, P

    2016-07-01

    The human endolymphatic sac (ES) is situated in a duplicature of the dura in the posterior cranial fossa and constitutes a part of the inner ear. The sac possesses immunological capacities and is responsible for a major part of the trans-epithelial ion transport occurring within the inner ear, via molecular mechanisms similar to that of the kidney collecting duct epithelia. Dysfunction of the trans-epithelial ion transport has been hypothesized as the reason for the endolymphatic hydrops occurring in Menieres diseases. Thus, candidate drug selection for medical treatment of Menieres disease has been based on a potential capability of improving trans-epithelial ion transport. However, recent human studies seems to rule out diuretic therapy and The Committee for Medicinal Products for Human Use redrew the recommendation for trimetazidine (Vastarel) treatment in the management of Meniere disease in 2012. This leaves betahistine (Betaserc) as the only drug for potential prevention of the incapacitating attacks of dizziness, tinnitus and hearing loss. However, the histamine receptors targeted by betahistine have never been demonstrated in the human ES. Accordingly, this study aims to investigate the expression of histamine receptors of the human ES epithelium and sub-epithelial stroma. Following sampling of human endolymphatic sac tissue during translabyrinthine surgery, the expression of histamine receptor genes was determined by cDNA microarray analysis. Results were subsequently verified by immuno-histochemistry. The combined results of microarrays and immuno-histochemistry showed expression of the histamine receptor HRH1 in the epithelial lining of the ES, whereas HRH3 was expressed exclusively in the sub-epithelial capillary network. Receptors HRH2 and -4 were not expressed. The present data provide the first direct evidence of a molecular rationale for betahistine treatment in Menieres disease. A potential betahistine effect in Menieres disease may primarily be

  16. Glucosamine and chondroitin sulfate supplementation to treat symptomatic disc degeneration: Biochemical rationale and case report

    van de Nes Jos CM

    2003-06-01

    Full Text Available Abstract Background Glucosamine and chondroitin sulfate preparations are widely used as food supplements against osteoarthritis, but critics are skeptical about their efficacy, because of the lack of convincing clinical trials and a reasonable scientific rationale for the use of these nutraceuticals. Most trials were on osteoarthritis of the knee, while virtually no documentation exists on spinal disc degeneration. The purpose of this article is to highlight the potential of these food additives against cartilage degeneration in general, and against symptomatic spinal disc degeneration in particular, as is illustrated by a case report. The water content of the intervertebral disc is a reliable measure of its degeneration/ regeneration status, and can be objectively determined by Magnetic Resonance Imaging (MRI signals. Case presentation Oral intake of glucosamine and chondroitin sulfate for two years associated with disk recovery (brightening of MRI signal in a case of symptomatic spinal disc degeneration. We provide a biochemical explanation for the possible efficacy of these nutraceuticals. They are bioavailable to cartilage chondrocytes, may stimulate the biosynthesis and inhibit the breakdown of their extracellular matrix proteoglycans. Conclusion The case suggests that long-term glucosamine and chondroitin sulfate intake may counteract symptomatic spinal disc degeneration, particularly at an early stage. However, definite proof requires well-conducted clinical trials with these food supplements, in which disc de-/regeneration can be objectively determined by MRI. A number of biochemical reasons (that mechanistically need to be further resolved explain why these agents may have cartilage structure- and symptom-modifying effects, suggesting their therapeutic efficacy against osteoarthritis in general.

  17. A rationale for maintaining the double containment requirement for plutonium shipments

    Channell, James K. [Environmental Evaluation Group, Albuquerque, NM (US); Anastas, George [Environmental Evaluation Group, Albuquerque, NM (US)

    2003-12-31

    Current U.S. Nuclear Regulatory Commission (NRC) transportation regulations (10 CFR 71.63 (b)) require that all shipments containing more than 20 curies of plutonium must be transported in packages that provide double containment. On April 30, 2002 the NRC issued a proposed rule that would eliminate §71.63(b) and the double containment requirement. NRC’s reasons for proposing elimination of §71.63(b) are: (1) compatibility with International Atomic Energy Agency Transportation Safety Standards (which do not have the requirement); (2) the current rule is inconsistent with the A1/A2 system since it applies only to plutonium; (3) double containment causes a heavier package and results in higher transportation costs; (4) the separate inner containment results in additional radiation exposure; and (5) while there would be additional protection from a separate inner container in an accident; this type of approach is not “risk informed nor performance based.” The Environmental Evaluation Group (EEG) has been a proponent of the double containment requirement for the Waste Isolation Pilot Plant (WIPP) shipments for twenty years. This requirement affects shipments to WIPP much more than any other current or planned shipping campaign because reactor fuel elements, metal or metal alloy, and vitrified high-level waste are exempt from §71.63(b). EEG submitted comments on the Proposed Rule on July 26, 2002 (Appendix C). This report is an update and expansion of the July 26, 2002 comments. Actual WIPP experience with shipments in the double contained TRUPACT-II package is used to respond to NRC arguments for deletion of §71.63(b) and offers a rationale for maintaining the current requirement.

  18. Overview of pathophysiology and rationale for treatment of sickle cell anemia.

    Rodgers, G P

    1997-07-01

    Sickle cell anemia occurs in individuals who are homozygous for a single nucleotide substitution in codon 6 of the beta-globin gene. This single mutation leads to the formation of abnormal hemoglobin, HbS (alpha2betas[s]2), which is much less soluble when deoxygenated than hemoglobin A (HbA) (alpha2beta2). This insolubility causes aggregates of HbS to form inside sickle erythrocytes as they traverse the circulation. With full deoxygenation, polymer becomes so extensive that the cells become sickled in shape. Yet, even with high oxygen saturation values, quantities of HbS polymer may be sufficient to alter the rheologic properties of sickle erythrocytes in the absence of morphologic changes, and cells can occlude end arterioles, leading to chronic hemolysis and microinfarction of diverse tissues. Ultimately, this process leads to vaso-occlusive crises and irreversible tissue damage. Nonetheless, the spectrum of disease severity even among patients with grossly equivalent hematologic indices suggests that many other factors-including genetic, cellular, physiologic, and psychosocial-play a substantial role in determining the course of this disorder. Of the genetic factors, the level of fetal hemoglobin in particular has been established to favorably modify the clinical manifestations of patients with sickle cell disease and related conditions. Recent advances in the understanding of the molecular and cellular pathophysiology of sickle cell disease, coupled with new insights into the developmental regulation of human globin gene expression, have provided the scientific impetus and clinical rationale to attempt to augment the postnatal production of fetal hemoglobin. Furthermore, contemporary understanding of the quantitative relationship between the extent of HbS polymerization within the red cells and the degree of red blood cell and/or organ pathology has now enabled investigators to predict to what extent this intracellular pathogenic process must be inhibited to

  19. The Practicum in Preservice Teacher Education: A Review of Empirical Studies

    Cohen, Esther; Hoz, Ron; Kaplan, Haya

    2013-01-01

    This literature review presents a systematic analysis of 113 empirical studies conducted between 1996 and 2009, portraying a picture of the rationales, goals, activities, roles, and outcomes in the different practicum settings in teacher education programs. The review shows that the rationale, goals, and activities in the different practicum…

  20. [Phosphate binders in renal patients: a point estimate from rationale, through evidences to the real world setting].

    Galassi, Andrea; Giovenzana, Maria Enrica; Galbiati, Eleonora; Auricchio, Sara; Colzani, Sara; Scanziani, Renzo

    2016-01-01

    Phosphate binders represent a common intervention in renal patients affected by chronic kidney disease and mineral bone disorder (CKD-MBD). Although counteracting P overload through binders adoption is argued by a physiology-driven approach, the efficacy of this intervention on hard endpoints remains poorly evident. The inconsistencies between rationale and methodological weakness, concerning the clinical relevance of P binding in chronic kidney disease, will be herein discussed with special focus on the need of a multi-factorial treatment against CKD-MBD, which is currently more achievable due to the variety of P binders and the rapid evolution of nutritional therapy, dialysis techniques and nursing science. PMID:27545626

  1. Planning for countering nuclear terrorism. Chapter 1. Motivation and redirection: rationale and achievements in the russian closed nuclear cities

    The non-proliferation rationale and achievements of the collaboration between the UK and Russia for a personnel redirection programme in the Closed Nuclear Cities is described. A framework for the interaction between demand and supply dimensions of proliferation threats is developed to show how redirection programmes to enable WMD (weapons of mass destruction) specialists move into civilian activities reduce these same threats. Early results from the UK-Russia Closed Nuclear Cities Partnership are presented and compared with the parallel US funded Nuclear Cities Initiative and similar local economic development measures

  2. The relevance of WHO injury surveillance guidelines for evaluation: learning from the aboriginal community-centered injury surveillance system (ACCISS) and two institution-based systems

    Auer Anna M; Dobmeier Teresa M; Haglund Bo JA; Tillgren Per

    2011-01-01

    Abstract Background Over the past three decades, the capacity to develop and implement injury surveillance systems (ISS) has grown worldwide and is reflected by the diversity of data gathering environments in which ISS operate. The capacity to evaluate ISS, however, is less advanced and existing evaluation guidelines are ambiguous. Furthermore, the applied relevance of these guidelines to evaluate ISS operating in various settings is unclear. The aim of this paper was to examine how the World...

  3. Proposed food and drug administration protection action guides for human food and animal feed: Rationale and limits

    The Food and Drug Administration is proposing Protective Action Guides (PAG's) to be used in the event that a radiological incident results in the radioactive contamination of human food and animal feed. PAG's are proposed for two levels of response: (1) PREVENTIVE PAG - establishes a level at which responsible officials should take protective action to prevent or reduce the concentration of radioactivity in food or animal feed. (2) EMERGENCY PAG - establishes a level at which responsible officials should isolate food containing radioactivity to prevent its introduction into commerce and determine whether condemnation or another disposition is appropriate. Derived response levels, which are defined as the concentration of radioactivity in food or animal feed corresponding to the above PAG's, are proposed for radionuclides of most significance. The presentation will discuss the supporting rationale as well as the numerical limits for the PAG's. This rationale is based on the process of risk assessment and cost-benefit and cost-effectiveness analysis. The risk assessment compares the risk of radiation exposure to the risk from prevalent hazards accepted by society and from variability of the natural radiation environment. The cost-benefit analysis is limited to protective actions efficacious in the reduction of iodine-131 dose to the thyroid via the milk pathway (condemnation and use of stored feed). In addition, the metabolic and agricultural transfer models that were used to calculate derived response levels will be described briefly. (author)

  4. The brain and somatic integration: insights into the standard biological rationale for equating "brain death" with death.

    Shewmon, A D

    2001-10-01

    The mainstream rationale for equating "brain death" (BD) with death is that the brain confers integrative unity upon the body, transforming it from a mere collection of organs and tissues to an "organism as a whole." In support of this conclusion, the impressive list of the brain's myriad integrative functions is often cited. Upon closer examination, and after operational definition of terms, however, one discovers that most integrative functions of the brain are actually not somatically integrating, and, conversely, most integrative functions of the body are not brain-mediated. With respect to organism-level vitality, the brain's role is more modulatory than constitutive, enhancing the quality and survival potential of a presupposedly living organism. Integrative unity of a complex organism is an inherently nonlocalizable, holistic feature involving the mutual interaction among all the parts, not a top-down coordination imposed by one part upon a passive multiplicity of other parts. Loss of somatic integrative unity is not a physiologically tenable rationale for equating BD with death of the organism as a whole. PMID:11588655

  5. Rationale and Methodology of Reprogramming for Generation of Induced Pluripotent Stem Cells and Induced Neural Progenitor Cells

    Tian, Zuojun; Guo, Fuzheng; Biswas, Sangita; Deng, Wenbin

    2016-01-01

    Great progress has been made regarding the capabilities to modify somatic cell fate ever since the technology for generation of induced pluripotent stem cells (iPSCs) was discovered in 2006. Later, induced neural progenitor cells (iNPCs) were generated from mouse and human cells, bypassing some of the concerns and risks of using iPSCs in neuroscience applications. To overcome the limitation of viral vector induced reprogramming, bioactive small molecules (SM) have been explored to enhance the efficiency of reprogramming or even replace transcription factors (TFs), making the reprogrammed cells more amenable to clinical application. The chemical induced reprogramming process is a simple process from a technical perspective, but the choice of SM at each step is vital during the procedure. The mechanisms underlying cell transdifferentiation are still poorly understood, although, several experimental data and insights have indicated the rationale of cell reprogramming. The process begins with the forced expression of specific TFs or activation/inhibition of cell signaling pathways by bioactive chemicals in defined culture condition, which initiates the further reactivation of endogenous gene program and an optimal stoichiometric expression of the endogenous pluri- or multi-potency genes, and finally leads to the birth of reprogrammed cells such as iPSCs and iNPCs. In this review, we first outline the rationale and discuss the methodology of iPSCs and iNPCs in a stepwise manner; and then we also discuss the chemical-based reprogramming of iPSCs and iNPCs. PMID:27104529

  6. Clinical use of quantitative cardiac perfusion PET: rationale, modalities and possible indications. Position paper of the Cardiovascular Committee of the European Association of Nuclear Medicine (EANM).

    Sciagrà, Roberto; Passeri, Alessandro; Bucerius, Jan; Verberne, Hein J; Slart, Riemer H J A; Lindner, Oliver; Gimelli, Alessia; Hyafil, Fabien; Agostini, Denis; Übleis, Christopher; Hacker, Marcus

    2016-07-01

    Until recently, PET was regarded as a luxurious way of performing myocardial perfusion scintigraphy, with excellent image quality and diagnostic capabilities that hardly justified the additional cost and procedural effort. Quantitative perfusion PET was considered a major improvement over standard qualitative imaging, because it allows the measurement of parameters not otherwise available, but for many years its use was confined to academic and research settings. In recent years, however, several factors have contributed to the renewal of interest in quantitative perfusion PET, which has become a much more readily accessible technique due to progress in hardware and the availability of dedicated and user-friendly platforms and programs. In spite of this evolution and of the growing evidence that quantitative perfusion PET can play a role in the clinical setting, there are not yet clear indications for its clinical use. Therefore, the Cardiovascular Committee of the European Association of Nuclear Medicine, starting from the experience of its members, decided to examine the current literature on quantitative perfusion PET to (1) evaluate the rationale for its clinical use, (2) identify the main methodological requirements, (3) identify the remaining technical difficulties, (4) define the most reliable interpretation criteria, and finally (5) tentatively delineate currently acceptable and possibly appropriate clinical indications. The present position paper must be considered as a starting point aiming to promote a wider use of quantitative perfusion PET and to encourage the conception and execution of the studies needed to definitely establish its role in clinical practice. PMID:26846913

  7. The Harvard/Brown Anxiety Research Project-Phase II (HARP-II): rationale, methods, and features of the sample at intake.

    Weisberg, Risa B; Beard, Courtney; Dyck, Ingrid; Keller, Martin B

    2012-05-01

    We describe the rationale, method, and intake demographic and clinical findings of the Harvard/Brown Anxiety Research Project-Phase II (HARP-II). HARP-II is the first prospective, observational, longitudinal study to describe the characteristics and course of anxiety in African American, Latino, and Non-Latino White individuals. Participants met criteria for at least one of the following disorders: Generalized Anxiety Disorder, Social Phobia, Panic Disorder with or without Agoraphobia, Agoraphobia without history of Panic Disorder, Post-traumatic Stress Disorder. Initial intake data, collected between 2004 and 2011, are presented for 165 African American, 150 Latino, and 172 Non-Latino White participants. Participants evidenced substantial psychiatric comorbidity (mean number of Axis I disorders=3.4), and moderate to severe symptoms and functional impairment. HARP-II will examine clinical course, in the context of potential socio-cultural and individual moderators (e.g., discrimination, acculturation, negative affect). Results should lead to improved understanding, prognostics, and treatment of anxiety in diverse populations. PMID:22410095

  8. Tracking study for top-off safety validation at SSRL

    A tracking study was performed at SSRL to identify necessary controls and to prove the safety of top-off operation from radiation hazard under such conditions. The safety rationale, tracking setup and the results are presented.

  9. Rationale and Development of a Security Assurance Index with Application toward the Development of a World Risk Index

    M. M. Plum; G. A. Beitel, PhD

    2006-06-01

    Assurance categories were previously developed to support the Department of Homeland Security’s efforts in the mitigation of Cyber Control System events. Defined according to the risk of life and economic loss, the minimum range is designated by policy, whereas the maximum limit seems to be constrained only by limits and interdependencies of the event. Use of this life / assets scale has proven to be helpful in managing risk due to the scale's ease of use, communication, and understanding. Suggestions have been made that this scale could be applied to all events of terror, disaster, and calamity of an international scale, with equally good results. This paper presents the history of some existing scales of disaster and assurance, the rationale behind the development of the original Security Assurance Index, and our proposed scale of disaster and calamity as a World Risk Index.

  10. Identification of potentially safe promising fungal cell factories for the production of polyketide natural food colorants using chemotaxonomic rationale

    Mapari, Sameer Shamsuddin; Meyer, Anne S.; Thrane, Ulf;

    2009-01-01

    biosynthesis of which has not yet been examined in detail. In addition, 4 out of the 10 chemotaxonomically selected promising Penicillium strains were shown to produce extracellular pigments in the liquid media using a solid support indicating future cell factory possibilities for polyketide natural food......Background: Colorants derived from natural sources look set to overtake synthetic colorants in market value as manufacturers continue to meet the rising demand for clean label ingredients-particularly in food applications. Many ascomycetous fungi naturally synthesize and secrete pigments and thus...... the enormous chemical diversity and biodiversity of ascomycetous fungi. This rationale could be very handy for the selection of potentially safe fungal cell factories not only for polyketide pigments but also for the other industrially important polyketides; the molecular and genetic basis for the...

  11. The metabolic rationale for a lack of cross-reactivity between sulfonamide antimicrobials and other sulfonamide-containing drugs.

    Lehmann, David F

    2012-06-01

    Sulfonamide antimicrobials (sulfamethoxazole) contain an arylamine group, oxidized by CYP2C9 to the hydroxylamine with subsequent auto-oxidation to a highly reactive [-nitroso-] intermediate is a necessary (if not sufficient) cause of drug hypersensitivity. Accordingly, xenobiotics that do not contain an arylamine cannot generate this reactive intermediate and do not cross react with sulfonamide antimicrobials. Despite this well-attested observation, product labeling and direct-to-consumer advertising for non-arylamine therapeutic classes of drugs containing the sulfonamido- functional group persist with a warning of the potential for cross-reactivity. It is hoped that by offering an explicit rationale for the lack of cross-reactivity will provide medical practitioners with a level comfort to proceed with prescribing medications such as thiazide diuretics and celecoxib for patients with a history of hypersensitivity to sulfonamide antimicrobials. PMID:23157194

  12. An objective rationale for the choice of regularisation parameter with application to global multiple-frequency S-wave tomography

    C. Zaroli

    2013-06-01

    Full Text Available In a linear ill-posed inverse problem, the regularisation parameter (damping controls the balance between minimising both the residual data misfit and the model norm. Poor knowledge of data uncertainties often makes the selection of damping rather arbitrary. To go beyond that subjectivity, an objective rationale for the choice of damping is presented, which is based on the coherency of delay-time estimates in different frequency bands. Our method is tailored to the problem of global Multiple-Frequency Tomography (MFT, using a data set of 287 078 S-wave delay-times measured in five frequency bands (10, 15, 22, 34, 51 s central periods. Whereas for each ray path the delay-time estimates should vary coherently from one period to the other, the noise most likely is not coherent. Thus, the lack of coherency of the information in different frequency bands is exploited, using an analogy with the cross-validation method, to identify models dominated by noise. In addition, a sharp change of behaviour of the model ℓ∞-norm, as the damping becomes lower than a threshold value, is interpreted as the signature of data noise starting to significantly pollute at least one model component. Models with damping larger than this threshold are diagnosed as being constructed with poor data exploitation. Finally, a preferred model is selected from the remaining range of permitted model solutions. This choice is quasi-objective in terms of model interpretation, as the selected model shows a high degree of similarity with almost all other permitted models (correlation superior to 98% up to spherical harmonic degree 80. The obtained tomographic model is displayed in mid lower-mantle (660–1910 km depth, and is shown to be compatible with three other recent global shear-velocity models. A wider application of the presented rationale should permit us to converge towards more objective seismic imaging of the Earth's mantle.

  13. Understanding the Rationale for Preschool Physical Education: Implications for Practitioners' and Children's Embodied Practices and Subjectivity Formation

    McEvilly, Nollaig; Atencio, Matthew; Verheul, Martine; Jess, Mike

    2013-01-01

    This paper provides an overview of selected academic research literature that underpins contemporary preschool physical education. We highlight and interrogate diverse rationales and beliefs that serve to influence and structure preschool physical education in various forms. We speculate as to how preschool practitioners and children might engage…

  14. Et Tu, Educator, Differentiated Staffing? Rationale and Model for a Differentiated Teaching Staff. TEPS Write-in Papers on Flexible Staffing Patterns, No. 4.

    English, Fenwick

    In developing a rationale for the reorganization of educational institutions, the author examines the fallacies inherent in current organizational practice and discusses the potential advantaged of differentiated staffing, particularly in terms of improved teacher morale, increased teacher effectiveness, and decreased teacher turnover. He presents…

  15. Efficacy and safety of oral strontium ranelate for the treatment of knee osteoarthritis: rationale and design of randomised, double-blind, placebo-controlled trial

    Cyrus Cooper

    2013-12-01

    Full Text Available Objective: The osteoporosis drug strontium ranelate dissociates bone remodelling processes. It also inhibits subchondral bone resorption and stimulates cartilage matrix formation in vitro. Exploratory studies in the osteoporosis trialsreport that strontium ranelate reduces biomarkers of cartilage degradation, and attenuates the progression and clinical symptoms of spinal osteoarthritis, suggesting symptom- and structure-modifying activity in osteoarthritis. We describethe rationale and design of a randomised trial evaluating the efficacy and safety of strontium ranelate in knee osteoarthritis.Research design, methods, and results: This double-blind, placebo-controlled trial (98 centres, 18 countries includes ambulatory Caucasian men and women aged ≥50 years with primary knee osteoarthritis of the medial tibiofemoralcompartment (Kellgren and Lawrence grade 2 or 3, joint space width (JSW 2.5 to 5 mm, and knee pain on most days in the previous month (intensity ≥40 mm on a visual analogue scale. Patients are randomly allocated to three groups (strontium ranelate 1 or 2g/day, or placebo. Follow-up is expected to last 3 years. The primary endpoint is radiographic change in JSW from baseline in each group versus placebo. The main clinical secondary endpoint is WOMAC score at the knee. Safety is assessed at every visit. It is estimated that 1600 patients are required to establish statistical significance with power >90% (0.2 mm ±10% between-group difference in change in JSW over 3 years. Recruitment started in April 2006. The results are expected in spring 2012.Clinical trial registration: The trial is registered on www.controlled-trials.com (number ISRCTN41323372.Conclusions: This randomised, double blind, placebo-controlled study will establish the potential of strontium ranelate in improving structure and symptoms in patients with knee osteoarthritis.

  16. Plant Study Guide.

    Brynildson, Inga

    Appropriate for secondary school botany instruction, this study guide focuses on the important roles of plants in human lives. Following a rationale for learning the basic skills of a botanist, separate sections discuss the process sunlight undergoes during photosynthesis, the flow of energy in the food chain, alternative plant lifestyles, plant…

  17. A randomized controlled trial to prevent childhood obesity through early childhood feeding and parenting guidance: Rationale and design of study

    Early and rapid growth in infants is strongly associated with early development and persistence of obesity in young children. Substantial research has linked child obesity/overweight to increased risks for serious health outcomes, which include adverse physical, psychological, behavioral, or social ...

  18. Limited agreement exists between rationale and practice in athletes' supplement use for maintenance of health: a retrospective study

    Mazanov Jason

    2007-10-01

    Full Text Available Abstract Background The widespread use of nutritional supplements among athletes is poorly understood. The prevalence of supplement intake and users' knowledge have been researched independently leading to useful, but disconnected, information on supplement use. Methods The 'UK Sport 2005 Drug Free Survey' data (n = 874 were re-analysed using association [χ2] and 'strength of association' tests [φ], to discover observed incongruencies between self-reported supplement use and the underlying motives. Results are given for test pairs between 'motive for use' [doctor's advice, avoiding sickness, overcoming injuries and enhancement of diet] and each supplement used and these were categorized as strong (φ > .7, intermediate (7 φ > .3 and weak (φ Results The use of selected supplements varied widely as follows: multivitamin (72.7%, vitamin C (70.4%, echinacea (30.8%, iron (29.8%, magnesium (11.0% and ginseng (8.3%. Associations with motive were found in 8 of the 10 test pairs which were expected from literature precedents, however only weak associations exist. Of these, four were associated with avoidance of sickness [iron (χ2 = 11.94, p χ2 = 6.43, p φ = .11, p = .011, vitamin C (χ2 = 54.67, p φ = .32, p χ2 = 40.34, p φ = .28, p χ2 = 7.64, p = .006; φ = .12, p = .006 and multivitamin (χ2 = 9.103, p = .003; φ = .13, p = .003; overcoming injuries with magnesium (χ2 = 6.99, p = .008; φ = .11, p = .008; doctors' advice and iron (χ2 = 35.00, p φ = .25, p = .001. Conclusion These results suggest a lack of understanding regarding supplements and health maintenance, except for vitamin C and echinacea. Furthermore, supplement use is apparently independent of physicians/dieticians' advice, except for iron. This may suggest a widespread circumvention of expert advice in the growing area of supplement use and therefore should be addressed to underscore potential health risks.

  19. Rationale and design of MinerAlocorticoid Receptor antagonist Tolerability Study-Heart Failure (ARTS-HF)

    Pitt, Bertram; Anker, Stefan D; Böhm, Michael;

    2015-01-01

    AIMS: To investigate the safety and potential efficacy of the novel non-steroidal mineralocorticoid receptor antagonist finerenone in patients with worsening chronic heart failure and reduced left ventricular ejection fraction (HFrEF) and at high risk of hyperkalaemia and worsening renal dysfunct......AIMS: To investigate the safety and potential efficacy of the novel non-steroidal mineralocorticoid receptor antagonist finerenone in patients with worsening chronic heart failure and reduced left ventricular ejection fraction (HFrEF) and at high risk of hyperkalaemia and worsening renal...

  20. Toward integrated and sustainable prevention against diabetes in rural China: study rationale and protocol of eCROPS

    Feng, Rui; Li, Kaichun; Cheng, Jing; Xie, Shaoyu; Chai, Jing; Wei, Pingfu; Wang, Debin

    2013-01-01

    Background Being an intermediate stage in the development of diabetes, pre-diabetics were estimated as high as 14% to 63% in China and one to three quarters of them will develop into diabetes within 10 years. It is well established that the risk of diabetes progression can be modified substantially and a whole range of proven guidelines, protocols and methodologies are available. Unfortunately, most proven interventions are seldom used in daily practice and this is especially true in resource...

  1. Considerations in the rationale, design and methods of the Strategic Timing of AntiRetroviral Treatment (START) study

    Babiker, Abdel G; Emery, Sean; Fätkenheuer, Gerd; Gordin, Fred M; Grund, Birgit; Lundgren, Jens D; Neaton, James D; Pett, Sarah L; Phillips, Andrew; Touloumi, Giota; Vjechaj, Michael J

    Untreated human immunodeficiency virus (HIV) infection is characterized by progressive depletion of CD4+ T lymphocyte (CD4) count leading to the development of opportunistic diseases (acquired immunodeficiency syndrome (AIDS)), and more recent data suggest that HIV is also associated with an incr...

  2. Study on burnup credit evaluation method at JAERI towards securing criticality safety rationale for management of spent fuel

    A higher initial 235U enrichment is currently required in the nuclear fuel fabrication specification to realize higher fuel burnup. Traditionally, in the criticality safety design of spent fuel (SF) storage and transportation (S/T) casks or facilities, the fuel is usually assumed to be at its full initial enrichment (so called fresh fuel assumption) to provide a large safety allowance, which is sometimes excessively given, for example requiring unnecessarily large space between fuel assemblies. The burnup credit taken for criticality safety design is firstly implemented to the SF Storage Rack of Rokkasho Reprocessing Facility, which is completed and expected for operation soon. Except for that, no burnup credit has been taken in criticality safety design for SF S/T casks or intermediate storage facilities in Japan. Since in the near future it is considered inevitable to handle spent fuel massively, it is desired to implement the rational S/T design saving safety and economy by taking into account the fuel burnup in the criticality safety control. Computer codes and data which are vital to assess criticality safety in the design stage of nuclear fuel cycle facility have been developed and prepared to constitute a Japanese criticality safety handbook at JAERI

  3. Combining Computational and Biochemical Studies for a Rationale on the Anti-Aromatase Activity of Natural Polyphenols

    Neves, Marco A. C.; Dinis, Teresa C. P.; Colombo, Giorgio; Melo, M. Luísa Sá e

    2007-01-01

    Aromatase, an enzyme of the cytochrome P450 family, is a very important pharmacological target, particularly for the treatment of breast cancer. The anti-aromatase activity of a set of natural polyphenolic compounds was evaluated in vitro. Strong aromatase inhibitors including flavones, flavanones, resveratrol, and oleuropein, with activities comparable to that of the reference anti-aromatase drug aminoglutethimide, were identified. Through the application of molecular modeling techniques bas...

  4. Synthesis and biological evaluation of novel s-triazine based aryl/heteroaryl entities: Design, rationale and comparative study

    Nirali S. Mewada

    2016-06-01

    Full Text Available The urgent need in search of new biological entities to fight back with recent drug-resistant microbial flora, has led us report a library of s-triazine derivatives. The intermediate 4-((4-chloro-6-methoxy-1,3,5-triazin-2-ylaminobenzonitrile 3 was substituted with various thiophenol, phenol, aniline and piperazine/piperidine/morpholine moieties to furnish the final 35 target compounds i.e. (4a–j, (5a–j, (6a–g and (7a–h, respectively. These compounds were screened for in vitro antibacterial evaluation against bacteria (Staphylococcus aureus MTCC 96, Bacillus cereus MTCC 619, Escherichia coli MTCC 739, and Pseudomonas aeruginosa MTCC 741 and antifungal activity against fungi (Candida albicans MTCC 183, Aspergillus niger MTCC 282, and Aspergillus clavatus MTCC 1323. The title compounds were further subjected for antituberculosis activity against Mycobacterium tuberculosis H37Rv strain using the BACTEC MGIT method. In this biological evaluation, thiophenol derivatives were found to be more active than the rest (i.e. -Thiophenol > -piperazine > -Aniline > -phenol. The final compounds were characterized by FT-IR, 1H NMR, 13C NMR, mass spectroscopy and elemental analysis.

  5. Toward 20 T magnetic resonance for human brain studies: opportunities for discovery and neuroscience rationale.

    Budinger, Thomas F; Bird, Mark D; Frydman, Lucio; Long, Joanna R; Mareci, Thomas H; Rooney, William D; Rosen, Bruce; Schenck, John F; Schepkin, Victor D; Sherry, A Dean; Sodickson, Daniel K; Springer, Charles S; Thulborn, Keith R; Uğurbil, Kamil; Wald, Lawrence L

    2016-06-01

    An initiative to design and build magnetic resonance imaging (MRI) and spectroscopy (MRS) instruments at 14 T and beyond to 20 T has been underway since 2012. This initiative has been supported by 22 interested participants from the USA and Europe, of which 15 are authors of this review. Advances in high temperature superconductor materials, advances in cryocooling engineering, prospects for non-persistent mode stable magnets, and experiences gained from large-bore, high-field magnet engineering for the nuclear fusion endeavors support the feasibility of a human brain MRI and MRS system with 1 ppm homogeneity over at least a 16-cm diameter volume and a bore size of 68 cm. Twelve neuroscience opportunities are presented as well as an analysis of the biophysical and physiological effects to be investigated before exposing human subjects to the high fields of 14 T and beyond. PMID:27194154

  6. Optimizing senior’s surgical care - Elder-friendly Approaches to the Surgical Environment (EASE) study: rationale and objectives

    Khadaroo, Rachel G.; Padwal, Raj S.; Adrian S. Wagg; Clement, Fiona; Warkentin, Lindsey M.; Holroyd-Leduc, Jayna

    2015-01-01

    Background It is estimated that seniors (≥65 years old) account for >50 % of acute inpatient hospital days and are presenting for surgical evaluation of acute illness in increasing numbers. Unfortunately, conventional acute care models rarely take into account needs of the elderly population. The failure to consider these special needs have resulted in poor outcomes, longer lengths of hospital stay and have likely increased the need for institutional care. Acute Care for the Elderly models on...

  7. Targeting Body Image Schema for Smoking Cessation among College Females: Rationale, Program Description, and Pilot Study Results

    Napolitano, Melissa A.; Lloyd-Richardson, Elizabeth E.; Fava, Joseph L.; Marcus, Bess H.

    2011-01-01

    Smoking among young adults is a significant public health problem. Despite the negative health effects, many young women smoke for weight and body image reasons. Understanding the factors that prompt young women to initiate and continue smoking is important for designing smoking cessation interventions. The aim of the current article is to outline…

  8. The Rationale for a Wider Concept of Inclusive Education for Teacher Education: A Case Study of Serbia

    Macura-Milovanovic, Suncica; Pantic, Natasa; Closs, Alison

    2012-01-01

    Teacher education for inclusive education (IE) is recognized as vital for improving quality and equity in education globally. In the Western Balkan countries it is also part of the transition process towards joining the European Union and has attracted international funding for IE-related projects. A key finding from research funded by the…

  9. HEALTHY study rationale, design and methods: Moderating risk of type 2 diabetes in multi-ethnic middle school students

    The HEALTHY primary prevention trial was designed and implemented in response to the growing numbers of children and adolescents being diagnosed with type 2 diabetes. The objective was to moderate risk factors for type 2 diabetes. Modifiable risk factors measured were indicators of adiposity and gly...

  10. Evaluation of a standard provision versus an autonomy promotive exercise referral programme:rationale and study design

    Jolly, Kate; Joan L. Duda; Daley, Amanda; Eves, Frank F.; Mutrie, Nanette; Ntoumanis, Nikos; Rouse, Peter C; Lodhia, Rekha; Williams, Geoffrey C

    2009-01-01

    Background: The National Institute of Clinical Excellence in the UK has recommended that the effectiveness of ongoing exercise referral schemes to promote physical activity should be examined in research trials. Recent empirical evidence in health care and physical activity promotion contexts provides a foundation for testing the utility of a Self Determination Theory (SDT)-based exercise referral consultation.Methods/Design: Design: An exploratory cluster randomised controlled trial comparin...

  11. SWITCH: rationale, design, and implementation of a community, school, and family-based intervention to modify behaviors related to childhood obesity

    Callahan Randi

    2008-06-01

    Full Text Available Abstract Background Although several previous projects have attempted to address the issue of child obesity through school-based interventions, the overall effectiveness of school-based programs on health-related outcomes in youth has been poor. Thus, it has been suggested that multi-level interventions that aim to influence healthy lifestyle behaviors at the community, school and family levels may prove more successful in the prevention of childhood obesity. Methods/Design This paper describes the rationale, design, and implementation of a community-, school-, and family-based intervention aimed at modifying key behaviors (physical activity, screen time (Internet, television, video games, and nutrition related to childhood obesity among third through fifth graders in two mid-western cities. The intervention involves a randomized study of 10 schools (5 intervention and 5 control schools. The intervention is being conducted during the duration of the academic year – approximately 9 months – and includes baseline and post-intervention measurements of physical activity, dietary intake, screen time and body composition. Discussion We hope this report will be useful to researchers, public health professionals, and school administrators and health professionals (nurses and physical/health educators seeking to develop similar prevention programs. It is obvious that more collaborative, inter-disciplinary, multi-level work is needed before a proven, effective intervention package to modify behaviors related to childhood obesity can be generally recommended. It is our hope that SWITCH is a step in that direction. Trial Registration ClinicalTrials.gov NCT00685555

  12. Active Fantasy Sports: Rationale and Feasibility of Leveraging Online Fantasy Sports to Promote Physical Activity

    Majewski, Sara; Standish, Melanie; Agarwal, Pooja; Podowski, Aleksandra; Carson, Rebecca; Eyesus, Biruk; Shah, Aakash; Schneider, Kristin L

    2014-01-01

    Background The popularity of active video games (AVGs) has skyrocketed over the last decade. However, research suggests that the most popular AVGs, which rely on synchronous integration between players’ activity and game features, fail to promote physical activity outside of the game or for extended periods of engagement. This limitation has led researchers to consider AVGs that involve asynchronous integration of players’ ongoing physical activity with game features. Rather than build an AVG de novo, we selected an established sedentary video game uniquely well suited for the incorporation of asynchronous activity: online fantasy sports. Objective The primary aim of this study was to explore the feasibility of a new asynchronous AVG—active fantasy sports—designed to promote physical activity. Methods We conducted two pilot studies of an active fantasy sports game designed to promote physical activity. Participants wore a low cost triaxial accelerometer and participated in an online fantasy baseball (Study 1, n=9, 13-weeks) or fantasy basketball (Study 2, n=10, 17-weeks) league. Privileges within the game were made contingent on meeting weekly physical activity goals (eg, averaging 10,000 steps/day). Results Across the two studies, the feasibility of integrating physical activity contingent features and privileges into online fantasy sports games was supported. Participants found the active fantasy sports game enjoyable, as or more enjoyable than traditional (sedentary) online fantasy sports (Study 1: t 8=4.43, P<.01; Study 2: t 9=2.09, P=.07). Participants in Study 1 increased their average steps/day, t 8=2.63, P<.05, while participants in Study 2 maintained (ie, did not change) their activity, t 9=1.57, P=.15). In postassessment interviews, social support within the game was cited as a key motivating factor for increasing physical activity. Conclusions Preliminary evidence supports potential for the active fantasy sports system as a sustainable and

  13. Ferrocyanide Safety Program rationale for removing six tanks from the safety watch list

    This report documents an in-depth study of single-shell tanks containing ferrocyanide wastes. Topics include: safety assessments, tank histories, supportive documentation about interim stabilization and planned remedial activities

  14. Ferrocyanide Safety Program rationale for removing six tanks from the safety watch list

    Borsheim, G.L.

    1993-09-01

    This report documents an in-depth study of single-shell tanks containing ferrocyanide wastes. Topics include: safety assessments, tank histories, supportive documentation about interim stabilization and planned remedial activities.

  15. A rationale method for evaluating unscrewing torque values of prosthetic screws in dental implants

    Felipe Miguel Saliba; Mayra Cardoso; Marcelo Ferreira Torres; Alexandre Carvalho Teixeira; Eduardo José Veras Lourenço; Daniel de Moraes Telles

    2011-01-01

    OBJECTIVES: Previous studies that evaluated the torque needed for removing dental implant screws have not considered the manner of transfer of the occlusal loads in clinical settings. Instead, the torque used for removal was applied directly to the screw, and most of them omitted the possibility that the hexagon could limit the action of the occlusal load in the loosening of the screws. The present study proposes a method for evaluating the screw removal torque in an anti-rotational device in...

  16. Advanced fuel cycles: a rationale and strategy for adopting the low-enriched-uranium fuel cycle

    A two-year study of alternatives to the natural uranium fuel cycle in CANDU reactors is summarized. The possible advanced cycles are briefly described. Selection criteria for choosing a cycle for development include resource utilization, economics, ease of implementaton, and social acceptability. It is recommended that a detailed study should be made with a view to the early implementation of the low-enriched uranium cycle. (LL)

  17. Deep vein thrombosis after ischemic stroke: rationale for a therapeutic trial

    Deep venous thrombosis (DVT) in the legs occurs in 23% to 75% of patients with acute ischemic stroke, and pulmonary embolism accounts for about 5% of deaths. New heparinoid substances, lacking the hazards of more established anticoagulants, raise the question of DVT prophylaxis for these patients. Two hundred fifty consecutive acute ischemic stroke patients were evaluated for the presence of DVT of the legs in a feasibility study for a trial of low-molecular-weight heparin prophylaxis. Forty-nine patients were found suitable for the study, of whom 11 (22.5%) developed DVT. All patients underwent clinical examination, I-125 fibrinogen leg scanning, and impedance plethysmography. Five patients were sufficiently alert and without serious neurologic deficits to justify DVT prophylaxis. Recent advances in noninvasive diagnostic techniques to detect DVT early and the development of relatively safe heparinoid compounds increase the need for a prophylactic study in patients with ischemic stroke

  18. “ASUKI Step” pedometer intervention in university staff: rationale and design

    Ainsworth Barbara E

    2012-08-01

    Full Text Available Abstract Background We describe the study design and methods used in a 9-month pedometer-based worksite intervention called “ASUKI Step” conducted at the Karolinska Institutet (KI in Stockholm, Sweden and Arizona State University (ASU in the greater Phoenix area, Arizona. Methods/design “ASUKI Step” was based on the theory of social support and a quasi-experimental design was used for evaluation. Participants included 2,118 faculty, staff, and graduate students from ASU (n = 712 and KI (n = 1,406 who participated in teams of 3–4 persons. The intervention required participants to accumulate 10,000 steps each day for six months, with a 3-month follow-up period. Steps were recorded onto a study-specific website. Participants completed a website-delivered questionnaire four times to identify socio-demographic, health, psychosocial and environmental correlates of study participation. One person from each team at each university location was randomly selected to complete physical fitness testing to determine their anthropometric and cardiovascular health and to wear an accelerometer for one week. Study aims were: 1 to have a minimum of 400 employee participants from each university site reach a level of 10, 000 steps per day on at least 100 days (3.5 months during the trial period; 2 to have 70% of the employee participants from each university site maintain two or fewer inactive days per week, defined as a level of less than 3,000 steps per day; 3 to describe the socio-demographic, psychosocial, environmental and health-related determinants of success in the intervention; and 4 to evaluate the effects of a pedometer-based walking intervention in a university setting on changes in self-perceived health and stress level, sleep patterns, anthropometric measures and fitness. Incentives were given for compliance to the study protocol that included weekly raffles for participation prizes and a grand finale trip to Arizona or Sweden

  19. Causes, rationales and dynamics: exploring the strategic security partnership between the European Union and Africa

    Siradag, Abdurrahim

    2012-01-01

    This study examines a strategic partnership in the areas of peace and security between the EU and Africa. The EU has been strengthening its institutional ties with African organisations since 2000, with security relations with Africa a priority on the EU’s agenda following the 9/11 attacks on the United States of America. The study shows the driving forces behind the establishment of the partnership, arguing that the EU’s economic interests have played a significant role in its development. I...

  20. Exploring the Rationales Expressed for Including a CSR Position to the Top Management Team

    Strand, Robert

    Recently, a number of positions with corporate social responsibility (CSR) in the position title have been introduced to the top management teams (TMTs) of some of the world’s largest corporations. I explore this phenomenon. I revisit 10 such positions identified in a previous study to add a...

  1. Rationale for short course primaquine in Africa to interrupt malaria transmission

    Eziefula Alice C

    2012-10-01

    Full Text Available Abstract Following the recent successes of malaria control in sub-Saharan Africa, the gametocytocidal drug primaquine needs evaluation as a tool to further reduce the transmission of Plasmodium falciparum malaria. The drug has scarcely been used in Africa because of concerns about its safety in people with glucose-6-phosphate dehydrogenase (G6PD deficiency. The evidence base for the use of primaquine as a transmission blocker is limited by a lack of comparable clinical and parasitological endpoints between trials. In March 2012, a group of experts met in London to discuss the existing evidence on the ability of primaquine to block malaria transmission, to define the roadblocks to the use of primaquine in Africa and to develop a roadmap to enable its rapid, safe and effective deployment. The output of this meeting is a strategic plan to optimize trial design to reach desired goals efficiently. The roadmap includes suggestions for a series of phase 1, 2, 3 and 4 studies to address specific hurdles to primaquine’s deployment. These include ex-vivo studies on efficacy, primaquine pharmacokinetics and pharmacodynamics and dose escalation studies for safety in high-risk groups. Phase 3 community trials are proposed, along with Phase 4 studies to evaluate safety, particularly in pregnancy, through pharmacovigilance in areas where primaquine is already deployed. In parallel, efforts need to be made to address issues in drug supply and regulation, to map G6PD deficiency and to support the evaluation of alternative gametocytocidal compounds.

  2. A Rationale for Developing Communication Training Programs: Issues and Resources for Curriculum Development.

    Curtis, Dan B.; Beebe, Steven A.

    A number of studies consistently identify the importance of communication skills, both oral and written, as vital to employability. Speech communication departments, however, have been slow either in responding to industry's needs or in informing students of the high correlation between communication skills and employability. Some of the possible…

  3. "Water Is Life"--Farmer Rationales and Water Saving in Khorezm, Uzbekistan: A Lifeworld Analysis

    Oberkircher, Lisa; Hornidge, Anna-Katharina

    2011-01-01

    Khorezm Province is located in the Amu Darya lowlands of Uzbekistan, where unsustainable use of irrigation water has led to the Aral Sea crisis. This study deals with the question of how farmers in Khorezm perceive water and its management and how this facilitates or prevents water conservation, or "water saving," in irrigated agriculture. To…

  4. A Thematic Review of Interactive Whiteboard Use in Science Education: Rationales, Purposes, Methods and General Knowledge

    Ormanci, Ummuhan; Cepni, Salih; Deveci, Isa; Aydin, Ozhan

    2015-01-01

    In Turkey and many other countries, the importance of the interactive whiteboard (IWB) is increasing, and as a result, projects and studies are being conducted regarding the use of the IWB in classrooms. Accordingly, in these countries, many issues are being researched, such as the IWB's contribution to the education process, its use in classroom…

  5. Tumor reoxygenation following administration of Mitogen-Activated Protein Kinase inhibitors: A rationale for combination with radiation therapy

    Background and purpose: The relevance of Mitogen Activated Protein Kinase (MAPK) inhibitors as co-treatments for radiation therapy is investigated, with special focus on a potential link between the MAPK pathway and tumor hypoxia, which is a critical determinant for response to therapy. Materials and methods: The effects of two MAPK inhibitors, Sorafenib and PD0325901, were monitored daily using in vivo EPR (Electron Paramagnetic Resonance) oximetry in FSaII and TLT tumor models in order to identify a window of reoxygenation, during which tumor blood flow, oxygen consumption and radiation sensitivity were assessed. Results: Reoxygenation was shown after two days of treatments with Sorafenib or PD0325901 in two tumor models, which was further successfully exploited with Sorafenib for improving the radiation response of FSaII tumors by a factor of 1.5. The increase in tumor oxygenation was shown to be the result of two major factors: (i) an increase in blood flow for Sorafenib, that might be linked to its anti-angiogenic effect (vascular normalization), and (ii) a decrease in oxygen consumption for Sorafenib and PD0325901, due to an alteration of the mitochondrial activity. Conclusion: We evidenced tumor reoxygenation in vivo following MAPK inhibition and suggest a rationale for the combination of radiation therapy with Sorafenib.

  6. Technical rationale and sampling procedures for assessing the effects of subsurface volatile organic contaminants on indoor air quality

    Wong, T.T.; Agar, J.G. [O' Connor Associates Environmental Inc., Calgary, AB (Canada); Gregoire, M.Y. [O' Connor Associates Environmental Inc., Winnipeg, MB (Canada)

    2003-07-01

    Volatile organic compounds (VOC) can affect indoor air quality through vapours released indoors by cigarette smoke, building materials, and common household solvents and cleaners. Therefore, the level of VOC contaminants might be a reliable indicator of the impact due to subsurface contamination. The following method of indirect assessment has been accepted by Canadian and American environmental regulatory bodies. This accepted method involves soil gas sampling close to the basement or ground floor slab of a building and VOC vapour transport modeling in order to estimate soil gas flow rates and VOC flux into a building. VOC flux concentration can be used to evaluate the potential human exposure to soil or groundwater derived VOCs, and to estimate the associated human health risks. This paper describes the shallow vapour sampler and sampling procedure specifically designed for collecting representative soil gas samples in the zone adjacent to a building basement or a ground floor slab, which was developed by O'Connor Associates. The results of numerical modeling, and the technical rationale behind the design of a soil gas sampling program for different soil types were presented. Soil type, depth to groundwater, and sampling well construction and their respective influence were discussed with reference to soil gas sampling programs and human health risk evaluations. 12 refs., 5 tabs., 6 figs.

  7. Diagnosis and Management of Iron Deficiency in CKD: A Summary of the NICE Guideline Recommendations and Their Rationale.

    Ratcliffe, Laura E K; Thomas, Wayne; Glen, Jessica; Padhi, Smita; Pordes, Ben A J; Wonderling, David; Connell, Roy; Stephens, Suzanne; Mikhail, Ashraf I; Fogarty, Damian G; Cooper, Jan K; Dring, Belinda; Devonald, Mark A J; Brown, Chris; Thomas, Mark E

    2016-04-01

    The UK-based National Institute for Health and Care Excellence (NICE) has updated its guidance on iron deficiency and anemia management in chronic kidney disease. This report outlines the recommendations regarding iron deficiency and their rationale. Serum ferritin alone or transferrin saturation alone are no longer recommended as diagnostic tests to assess iron deficiency. Red blood cell markers (percentage hypochromic red blood cells, reticulocyte hemoglobin content, or reticulocyte hemoglobin equivalent) are better than ferritin level alone at predicting responsiveness to intravenous iron. When red blood cell markers are not available, a combination of transferrin saturation iron status testing and treatment strategies, using percentage hypochromic red blood cells > 6% was the most cost-effective strategy for both hemodialysis and nonhemodialysis patients. A trial of oral iron replacement is recommended in people not receiving an erythropoiesis-stimulating agent (ESA) and not on hemodialysis therapy. For children receiving ESAs, but not treated by hemodialysis, oral iron should be considered. In adults and children receiving ESAs and/or on hemodialysis therapy, intravenous iron should be offered. When giving intravenous iron, high-dose low-frequency administration is recommended. For all children and for adults receiving in-center hemodialysis, low-dose high-frequency administration may be more appropriate. PMID:26763385

  8. Comparison of the rationale used in setting occupational exposure standards for ionizing radiation and hazardous chemical substances

    Ten chemicals which create significant occupational hazard are reviewed. They are toluene diisocyanate, hydrogen fluoride, n-hexane, carbon disulphide, cadmium, inorganic mercury, cobalt, nitroglycerol, silica and vinyl chloride. Each is discussed under the headings of physiological intake and elimination in humans, characteristics of acute and chronic toxicity, sites of occupational exposure and rationale for limits of such exposure. Since radioactive substances yield ionizing radiation as the common hazard the treatment of the current permissible levels of exposure is somewhat simpler. Having set out industrial standards for exposure to hazardous substances and radionuclides, a detailed comparison is made. Exposure limits to ioninzing radiation are sufficiently low to remove the appearance of directly related injury. It is expected however that low level exposure may have a stochastic effect, that is, there is the possibility of a slightly increased incidence of neoplasms in a large exposed population, but numbers will be too small to be able to attribute any particular case to the exposure. TLVs on the other hand, depending on the particular chemical, may be high enough in the workplace to permit some directly related signs or symptoms in the exposed individual. 244 refs

  9. Continuity in care trajectories of older chronically ill patients in a battlefield of competing rationales

    Kjerholt, Mette; Wagner, L.; Delmar, C.;

    2014-01-01

    perspective in older, chronically ill patients' care as reflected in nursing staff's communication about the patients. DESIGN: Explorative Participatory Action Research (PAR). SETTING: An acute, general medical ward at a Danish university hospital. PARTICIPANTS: Hospital and municipality nurses (n = 29......BACKGROUND: Continuity is crucial when caring for older chronically ill patients. Research has shown that the integration of patients' own perspectives on their situation is of utmost importance for continuity and quality of care. Studies have, however, demonstrated a number of problems with health......). Nursing records (n = 12). METHOD: Field studies: observations, interviews, nursing records audits and logs. Data were subject to manifest and latent content analysis. RESULTS: Participants were aware of the importance of ensuring continuity, a comprehensive approach and integration of the patient...

  10. Optimization of diagnostic imaging use in patients with acute abdominal pain (OPTIMA: Design and rationale

    Bossuyt Patrick MM

    2007-08-01

    Full Text Available Abstract Background The acute abdomen is a frequent entity at the Emergency Department (ED, which usually needs rapid and accurate diagnostic work-up. Diagnostic work-up with imaging can consist of plain X-ray, ultrasonography (US, computed tomography (CT and even diagnostic laparoscopy. However, no evidence-based guidelines exist in current literature. The actual diagnostic work-up of a patient with acute abdominal pain presenting to the ED varies greatly between hospitals and physicians. The OPTIMA study was designed to provide the evidence base for constructing an optimal diagnostic imaging guideline for patients with acute abdominal pain at the ED. Methods/design Thousand consecutive patients with abdominal pain > 2 hours and Discussion This study aims to provide the evidence base for the development of a diagnostic algorithm that can act as a guideline for ED physicians to evaluate patients with acute abdominal pain.

  11. THE RATIONALE BEHIND WEAKLY TIED NETWORKING OF THE BANGLADESHI DIASPORA IN MALAYSIA

    Nayeem, S.

    2012-01-01

    This paper is an exploration of the survival strategies of the Bangladeshi Diaspora in Malaysia. To cope with the realities, Bangladeshi migrants develop different forms of survival strategies. As a result intra and inter-ethnic strong and weak ties are formed in the receiving country. Empirical analysis depicts that respondents with weak ties have higher income mobility than those with strong ties. It also demonstrates that the Bangladeshi migrants of the study areas do not restrict themselv...

  12. Road transport social costs in Spain: a new rationale for pricing policy

    Di Ciommo, Floridea; Monzón de Cáceres, Andrés; Comendador Arquero, Julio

    2010-01-01

    Like all EU countries, Spain should design and promote a fair and homogeneous generalized road pricing scheme. Tolls should vary according to infrastructure damage, degree of congestion, risk of accident, and environmental nuisances. An initial study (Spanish road pricing model project: META) of interurban transport pricing has been carried out at national level, considering the valuation of the internal and external costs to define efficient road pricing schemes of different type of ro...

  13. Learning in Social Networks: Rationale and Ideas for Its Implementation in Higher Education

    Marialexa Olivera-Smith; Ibis M. Alvarez

    2013-01-01

    The internet has fast become a prevalent medium for collaboration between people and social networks, in particular, have gained vast popularity and relevance over the past few years. Within this framework, our paper will analyse the role played by social networks in current teaching practices. Specifically, we focus on the principles guiding the design of study activities which use social networks and we relate concrete experiences that show how they contribute to improving teaching and lear...

  14. Transaortic transcatheter aortic valve implantation - rationale and design of the multicenter, multinational prospective ROUTE registry

    Bramlage, Peter; Romano, Mauro; Bonaros, Nikolaos; Cocchieri, Ricardo; Jagielak, Dariusz; Frank, Derk; Bapat, Vinayak

    2014-01-01

    Background Transaortic transcatheter aortic valve implantation (TAo-TAVI) is a recently developed approach that provides an alternative delivery route for valve replacement in patients with vascular abnormalities or existing comorbidities. While initial studies have shown the principal efficacy and safety, the real world effectiveness and safety of this approach remains to be fully assessed. Methods/Design In this regard, the Registry Of the Utilization of the TAo-TAVI approach using the Edwa...

  15. Rationale and Practical Techniques for Mouse Models of Early Vein Graft Adaptations

    Yu, Peng; Nguyen, Binh T.; Tao, Ming; Campagna, Christina; Ozaki, C. Keith

    2010-01-01

    Mouse models serve as relatively new yet powerful research tools to study intimal hyperplasia and wall remodeling of vein bypass graft failure. Several model variations have been reported in the past decade. However, the approach demands thoughtful preparation, selected sophisticated equipment, microsurgical technical expertise, advanced tissue processing and data acquisition. This review compares several described models, and aims (building on our personal experiences) to practically aid the...

  16. Ascorbic Acid and the Brain: Rationale for the Use against Cognitive Decline

    Harrison, Fiona E.; Bowman, Gene L.; Maria Cristina Polidori

    2014-01-01

    This review is focused upon the role of ascorbic acid (AA, vitamin C) in the promotion of healthy brain aging. Particular attention is attributed to the biochemistry and neuronal metabolism interface, transport across tissues, animal models that are useful for this area of research, and the human studies that implicate AA in the continuum between normal cognitive aging and age-related cognitive decline up to Alzheimer’s disease. Vascular risk factors and comorbidity relationships with cogniti...

  17. A rationale to target the SWI/SNF complex for cancer therapy

    Hohmann, Anja F.; Vakoc, Christopher R.

    2014-01-01

    SWI/SNF is a multi-subunit chromatin remodeling complex that performs fundamental roles in gene regulation, cell lineage specification, and organismal development. Mutations that inactivate SWI/SNF subunits are found in nearly 20% of human cancers, which indicates that the proper functioning of this complex is necessary to prevent tumor formation in diverse tissues. Recent studies show that SWI/SNF-mutant cancers depend on residual SWI/SNF complexes for their aberrant growth, thus revealing s...

  18. Underdiagnosis of Chronic Obstructive Pulmonary Disease: A Rationale for Spirometry as a Screening Tool

    R Andrew McIvor; Tashkin, Donald P.

    2001-01-01

    Chronic obstructive pulmonary disease (COPD) is associated with significant morbidity and mortality. It is the fourth leading cause of death in the United States, and its impact on quality of life can be severe. The debate on spirometry as a screening tool has been raised and dropped on various occasions over the past 30 years. This paper readdresses the debate in the light of recent evidence from population studies. Spirometry is an underused, easy to perform office-based procedure that has ...

  19. Transfusion-related Acute Lung Injury in the Critically Ill: Prospective Nested Case-Control Study

    Gajic, Ognjen; Rana, Rimki; Winters, Jeffrey L.; Yilmaz, Murat; Mendez, Jose L.; Rickman, Otis B.; O'Byrne, Megan M.; Evenson, Laura K; Malinchoc, Michael; DeGoey, Steven R.; Afessa, Bekele; Hubmayr, Rolf D.; Moore, S. Breanndan

    2007-01-01

    Rationale: Acute lung injury (ALI) that develops 6 hours after transfusion (TRALI) is the leading cause of transfusion-related mortality. Several transfusion characteristics have been postulated as risk factors for TRALI, but the evidence is limited to retrospective studies.

  20. Archaeology in Social Studies: An Integrated Approach. Theme: Archaeology in the Classroom.

    Devine, Heather

    1989-01-01

    Provides a rationale for integrating archaeology into the social studies classroom, suggesting archaeology topics that satisfy knowledge goals in the curriculum. Describes field trip, excavation, and experimental archaeology activities. Includes lists of archaeological agencies and teacher references. (LS)