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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

    Directory of Open Access Journals (Sweden)

    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

    DEFF Research Database (Denmark)

    Clemmensen, Peter

    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...... 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. The Danish Alzheimer Intervention Study: Rationale, Study Design and Baseline Characteristics of the Cohort

    DEFF Research Database (Denmark)

    Waldemar, G.; Waldorff, F.B.; Buss, D.V.

    2011-01-01

    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 characteristics...

  4. Inflammation and Exercise (INFLAME): study rationale, design, and methods

    Science.gov (United States)

    Thompson, Angela; Mikus, Catherine; Rodarte, Ruben Q.; Distefano, Brandy; Priest, Elisa L.; Sinclair, Erin; Earnest, Conrad P.; Blair, Steven N.; Church, Timothy S.

    2008-01-01

    Purpose The INFLAME study is designed to determine the effect of exercise training on elevated high-sensitivity C-Reactive Protein (CRP) concentrations in initially sedentary women and men. Methods INFLAME will recruit 170 healthy, sedentary women and men with elevated CRP (≥2.0 mg/L) to be randomized to either an exercise group or non-exercise control group. Exercising individuals will participate in four months of supervised aerobic exercise with a total energy expenditure of 16 kcal • kg−1 • week−1 (KKW). Exercise intensity will be 60–80% of maximal oxygen consumption (VO2 max). Outcome The primary outcome will be change in plasma CRP concentration. Secondary outcomes include visceral adiposity, the cytokines IL-6 and TNF-α, and heart rate variability (HRV) in order to examine potential biological mechanisms whereby exercise might affect CRP concentrations. Summary INFLAME will help us understand the effects of moderate to vigorous exercise on CRP concentrations in sedentary individuals. To our knowledge this will be the largest training study specifically designed to examine the effect of exercise on CRP concentrations. This study has the potential to influence therapeutic applications since CRP measurement is becoming an important clinical measurement in Coronary Heart Disease risk assessment. This study will also contribute to the limited body of literature examining the effect of exercise on the variables of visceral adiposity, cytokines, and heart rate variability. PMID:18024231

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

    OpenAIRE

    March John S; Khanna Muniya S; Sapyta Jeffrey J; Moore Phoebe S; Garcia Abbe M; Choate-Summers Molly L; Freeman Jennifer B; Foa Edna B; Franklin Martin E

    2009-01-01

    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...

  6. Does Design Rationale Enhance Creativity?

    Directory of Open Access Journals (Sweden)

    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.

  7. Rationale and Design of the Echocardiographic Study of Hispanics / Latinos (ECHO-SOL)

    Science.gov (United States)

    Rodriguez, Carlos J.; Dharod, Ajay; Allison, Matthew A.; Shah, Sanjiv J.; Hurwitz, Barry; Bangdiwala, Shrikant I.; Gonzalez, Franklyn; Kitzman, Dalane; Gillam, Linda; Spevack, Daniel; Dadhania, Rupal; Langdon, Sarah; Kaplan, Robert

    2015-01-01

    Background Information regarding the prevalence and determinants of cardiac structure and function (systolic and diastolic) among the various Hispanic background groups in the United States is limited. Methods and Results The Echocardiographic Study of Latinos (ECHO-SOL) ancillary study recruited 1,824 participants through a stratified-sampling process representative of the population-based Hispanic Communities Health StudyStudy of Latinos (HCHS-SOL) across four sites (Bronx, NY; Chicago, Ill; San Diego, Calif; Miami, Fla). The HCHS-SOL baseline cohort did not include an echo exam. ECHO-SOL added the echocardiographic assessment of cardiac structure and function to an array of existing HCHS-SOL baseline clinical, psychosocial, and socioeconomic data and provides sufficient statistical power for comparisons among the Hispanic subgroups. Standard two-dimensional (2D) echocardiography protocol, including M-mode, spectral, color and tissue Doppler study was performed. The main objectives were to: 1) characterize cardiac structure and function and its determinants among Hispanics and Hispanic subgroups; and 2) determine the contributions of specific psychosocial factors (acculturation and familismo) to cardiac structure and function among Hispanics. Conclusion We describe the design, methods and rationale of currently the largest and most comprehensive study of cardiac structure and function exclusively among US Hispanics. ECHO-SOL aims to enhance our understanding of Hispanic cardiovascular health as well as help untangle the relative importance of Hispanic subgroup heterogeneity and sociocultural factors on cardiac structure and function. (Ethn Dis. 2015;25[2]:180–186) PMID:26118146

  8. Rationale and design of the Japan molecular epidemiology for lung cancer study.

    Science.gov (United States)

    Kawaguchi, Tomoya; Ando, Masahiko; Ito, Norimasa; Isa, Shun-Ichi; Tamiya, Akihiro; Shimizu, Shigeki; Saka, Hideo; Kubo, Akihito; Koh, Yasuhiro; Matsumura, Akihide

    2013-09-01

    We present the rationale for the Japan Molecular Epidemiology for Lung Cancer study designed to elucidate molecular mechanisms of carcinogenesis in smokers and never-smokers with non-small-cell lung cancer. This prospective, ongoing, multicenter study is being conducted nationwide in Japan. Although there is no doubt that active smoking is the major cause of lung cancer, the contribution of other possible factors, including environmental tobacco or wood smoke, human papilloma virus, radon, occupational exposures, and genetic susceptibility, is highly likely, based on studies of never-smokers with non-small-cell lung cancer. Because of the predominance of women in the never-smoker subgroup, the role of female hormones in lung cancer development has also been considered. We hypothesize that driver mutations, which are critical for the development of lung cancer, are triggered by the environmental factors with or without the influence of the hormone. The SWOG-led intergroup molecular epidemiology study S0424 was conducted to focus on these issues by using a detailed questionnaire and specimen collection in statistically significant cohorts of smokers and never-smokers from both sexes. The Japan Molecular Epidemiology for Lung Cancer study follows and extends the S0424 molecular epidemiology concept in principle by using a similar approach that will facilitate future comparisons between the studies but with a greater focus on more recently defined driver mutations and broad genomic sequencing.

  9. High risk cohort study for psychiatric disorders in childhood: rationale, design, methods and preliminary results.

    Science.gov (United States)

    Salum, Giovanni Abrahão; Gadelha, Ary; Pan, Pedro Mario; Moriyama, Tais Silveira; Graeff-Martins, Ana Soledade; Tamanaha, Ana Carina; Alvarenga, Pedro; Valle Krieger, Fernanda; Fleitlich-Bilyk, Bacy; Jackowski, Andrea; Sato, João Ricardo; Brietzke, Elisa; Polanczyk, Guilherme Vanoni; Brentani, Helena; de Jesus Mari, Jair; Do Rosário, Maria Conceição; Manfro, Gisele Gus; Bressan, Rodrigo Affonseca; Mercadante, Marcos Tomanik; Miguel, Eurípedes Constantino; Rohde, Luis Augusto

    2015-03-01

    The objective of this study is to present the rationale, methods, design and preliminary results from the High Risk Cohort Study for the Development of Childhood Psychiatric Disorders. We describe the sample selection and the components of each phases of the study, its instruments, tasks and procedures. Preliminary results are limited to the baseline phase and encompass: (i) the efficacy of the oversampling procedure used to increase the frequency of both child and family psychopathology; (ii) interrater reliability and (iii) the role of differential participation rate. A total of 9937 children from 57 schools participated in the screening procedures. From those 2512 (random = 958; high risk = 1554) were further evaluated with diagnostic instruments. The prevalence of any child mental disorder in the random strata and high-risk strata was 19.9% and 29.7%. The oversampling procedure was successful in selecting a sample with higher family rates of any mental disorders according to diagnostic instruments. Interrater reliability (kappa) for the main diagnostic instrument range from 0.72 (hyperkinetic disorders) to 0.84 (emotional disorders). The screening instrument was successful in selecting a sub-sample with "high risk" for developing mental disorders. This study may help advance the field of child psychiatry and ultimately provide useful clinical information.

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

    Directory of Open Access Journals (Sweden)

    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

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

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    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.

  12. Rationale, design and methods of the HEALTHY study behavior intervention component.

    Science.gov (United States)

    Venditti, E M; Elliot, D L; Faith, M S; Firrell, L S; Giles, C M; Goldberg, L; Marcus, M D; Schneider, M; Solomon, S; Thompson, D; Yin, Z

    2009-08-01

    HEALTHY was a multi-center primary prevention trial designed to reduce risk factors for type 2 diabetes in adolescents. Seven centers each recruited six middle schools that were randomized to either intervention or control. The HEALTHY intervention integrated multiple components in nutrition, physical education, behavior change and communications and promotion. The conceptual rationale as well as the design and development of the behavior intervention component are described. Pilot study data informed the development of the behavior intervention component. Principles of social learning and health-related behavior change were incorporated. One element of the behavior intervention component was a sequence of peer-led, teacher-facilitated learning activities known as FLASH (Fun Learning Activities for Student Health). Five FLASH modules were implemented over five semesters of the HEALTHY study, with the first module delivered in the second semester of the sixth grade and the last module in the second semester of the eighth grade. Each module contained sessions that were designed to be delivered on a weekly basis to foster self-awareness, knowledge, decision-making skills and peer involvement for health behavior change. FLASH behavioral practice incorporated individual and group self-monitoring challenges for eating and activity. Another element of the behavior intervention component was the family outreach strategy for extending changes in physical activity and healthy eating beyond the school day and for supporting the student's lifestyle change choices. Family outreach strategies included the delivery of newsletters and supplemental packages with materials to promote healthy behavior in the home environment during school summer and winter holiday breaks. In conclusion, the HEALTHY behavior intervention component, when integrated with total school food and physical education environmental changes enhanced by communications and promotional campaigns, is a feasible and

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

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    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.

  14. Rationale, design, and methodology for the optimizing outcomes in women with gestational diabetes mellitus and their infants study

    OpenAIRE

    Berry, Diane C.; Neal, Madeline; Hall, Emily G.; Schwartz, Todd A.; Verbiest, Sarah; Bonuck, Karen; Goodnight, William; Brody, Seth; Dorman, Karen F; Menard, Mary K; Stuebe, Alison M.

    2013-01-01

    Background Women who are diagnosed with gestational diabetes mellitus (GDM) are at increased risk for developing prediabetes and type 2 diabetes mellitus (T2DM). To date, there have been few interdisciplinary interventions that target predominantly ethnic minority low-income women diagnosed with GDM. This paper describes the rationale, design and methodology of a 2-year, randomized, controlled study being conducted in North Carolina. Methods/Design Using a two-group, repeated measures, experi...

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

    Directory of Open Access Journals (Sweden)

    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

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

    Science.gov (United States)

    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.

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

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    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

  18. Prospective study of one million deaths in India: rationale, design, and validation results.

    Directory of Open Access Journals (Sweden)

    Prabhat Jha

    2006-02-01

    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

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

    Directory of Open Access Journals (Sweden)

    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

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

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    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

  1. Population-based cohort study of outpatients with pneumonia: rationale, design and baseline characteristics

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    Eurich Dean T

    2012-06-01

    Full Text Available Abstract Background The vast majority of research in the area of community-acquired pneumonia (CAP has been based on patients admitted to hospital. And yet, the majority of patients with CAP are treated on an ambulatory basis as outpatients, either by primary care physicians or in Emergency Departments. Few studies have been conducted in outpatients with pneumonia, and there is a paucity of data on short and long term morbidity or mortality and associated clinical correlates in this group of patients. Methods From 2000–2002, all CAP patients presenting to 7 Emergency Departments in Edmonton, Alberta, Canada were prospectively enrolled in a population-based registry. Clinical data, including pneumonia severity index (PSI were collected at time of presentation. Patients discharged to the community were then followed for up to 5 years through linkage to the provincial administrative databases. The current report provides the rationale and design for the cohort, as well as describes baseline characteristics and 30-day morbidity and mortality. Results The total sample included 3874 patients. After excluding patients who were hospitalized, died or returned to the Emergency Department the same day they were initially discharged (n = 451; 12 %, and patients who could not be linked to provincial administrative databases (n = 237; 6 %, the final cohort included 3186 patients treated according to a validated clinical management pathway and discharged back to the community. Mean age was 51 (SD = 20 years, 53 % male; 4 % resided in a nursing home, 95 % were independently mobile, and 88 % had mild (PSI class I-III pneumonia. Within 30-days, return to Emergency Department was common (25 % as was hospitalization (8 % and 1 % of patients had died. Conclusions To our knowledge, this represents the largest clinically-detailed outpatient CAP cohort assembled to date and will add to our understanding of the determinants and outcomes

  2. Africa South of the Sahara, Rationale and Introduction: An Experimental Program of Study for Secondary School Social Studies Students. Teaching Guide.

    Science.gov (United States)

    Carnegie-Mellon Univ., Pittsburgh, PA. Project Africa.

    The articulation of a rationale for Project Africa's instructional program, the collection of materials for improving inquiry-oriented instruction at the secondary level about Africa south of the Sahara, and the preparation of teaching and study guides have been completed. This geographic region, rather than the whole continent, was chosen to…

  3. Rationale for delayed-start study of pramipexole in Parkinson's disease: the PROUD study.

    Science.gov (United States)

    Schapira, Anthony H V; Albrecht, Stefan; Barone, Paolo; Comella, Cynthia L; McDermott, Michael P; Mizuno, Yoshikuni; Poewe, Werner; Rascol, Olivier; Marek, Kenneth

    2010-08-15

    Perhaps the most important unmet need in Parkinson's disease (PD) is the ability to slow or prevent progression of the neurodegeneration that underlies the motor and nonmotor features of this disorder. Pramipexole, a dopamine agonist used for the symptomatic treatment of PD, has demonstrated neuroprotective properties in laboratory studies. The PRamipexole On Underlying Disease (PROUD) study is a randomized, double-blind clinical trial evaluating the ability of pramipexole to modify disease progression using a delayed-start design. PD patients (n = 535) with mean age 62.5 years, mean duration since diagnosis of 4.4 months, and mean total Unified Parkinson's disease Rating Scale (UPDRS) score of 24.5 were recruited. In Phase I, patients were randomly assigned to be titrated to 1.5 mg pramipexole or placebo and maintained on study drug for 6-9 months. In Phase II, all patients were titrated to 1.5 mg pramipexole and maintained on study drug until the end of the study at 15 months. No rescue medication was allowed in the protocol. The primary endpoint is the change in total UPDRS score (parts I-III) from baseline to 15 months. A range of secondary endpoints separately assess UPDRS subscales, quality of life, depression, and impulse control disorders. A sub-study examined dopamine transporter uptake scans at baseline and 15 months. The results of PROUD will provide insight into the potential for early versus delayed treatment with pramipexole to modify motor outcome at 15 months in recently diagnosed PD patients.

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

    Directory of Open Access Journals (Sweden)

    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.

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

    Directory of Open Access Journals (Sweden)

    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

  6. 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

    Directory of Open Access Journals (Sweden)

    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

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

    Science.gov (United States)

    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.

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

    Science.gov (United States)

    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.

  9. Combined targeting of EGFR-dependent and VEGF-dependent pathways: rationale, preclinical studies and clinical applications.

    Science.gov (United States)

    Tortora, Giampaolo; Ciardiello, Fortunato; Gasparini, Giampietro

    2008-09-01

    Cellular heterogeneity, redundancy of molecular pathways and effects of the microenvironment contribute to the survival, motility and metastasis of cells in solid tumors. It is unlikely that tumors are entirely dependent on only one abnormally activated signaling pathway; consequently, treatment with an agent that interferes with a single target may be insufficient. Combined blockade of functionally linked and relevant multiple targets has become an attractive therapeutic strategy. The EGFR and ERBB2 (HER2) pathways and VEGF-dependent angiogenesis have a pivotal role in cancer pathogenesis and progression. Robust experimental evidence has shown that these pathways are functionally linked and has demonstrated a suggested role for VEGF in the acquired resistance to anti-ERBB drugs when these receptors are pharmacologically blocked. Combined inhibition of ERBB and VEGF signaling interferes with a molecular feedback loop responsible for acquired resistance to anti-ERBB agents and promotes apoptosis while ablating tumor-induced angiogenesis. To this aim, either two agents highly selective against VEGF and ERBB respectively, or, alternatively, a single multitargeted agent, can be used. Preclinical studies have proven the efficacy of both these approaches and early clinical studies have provided encouraging results. This Review discusses the experimental rationale for, preclinical studies of and clinical trials on combined blockade of ERBB and VEGF signaling.

  10. The Study of the Effects of Diet on Metabolism and Nutrition (STEDMAN) weight loss project: Rationale and design.

    Science.gov (United States)

    Haqq, Andrea M; Lien, Lillian F; Boan, Jarol; Arlotto, Michelle; Slentz, Cris A; Muehlbauer, Michael J; Rochon, James; Gallup, Dianne; McMahon, Ross L; Bain, James R; Stevens, Robert; Millington, David; Butler, Mark D; Newgard, Christopher B; Svetkey, Laura P

    2005-12-01

    This paper outlines the rationale and design of the Study of the Effects of Diet on Metabolism and Nutrition (STEDMAN) weight loss project, in which detailed biologic profiling of three hundred and fifty obese individuals (body mass index (BMI): 30-50 kg/m(2)) will be conducted as they lose weight via seven distinct interventions. These profiles will be compared to those of fifty normal, healthy, control participants (BMI: 18.5-24.9 kg/m(2)). The interventions include the following: Roux-en-Y gastric bypass surgery, dietary interventions of differing macronutrient composition and diverse pharmacologic interventions. Outcome variables include eight conventional metabolites and CRP measured by standard clinical chemistry techniques, twenty hormones of energy balance and fuel homeostasis measured by radioimmunoassay (RIA) or by enzyme-linked Immunosorbent assay (ELISA), ten pro- and anti-inflammatory cytokines measured using Luminex xMAP technology, one hundred and one intermediary metabolites measured by targeted mass-spectrometry-based methods, and physiologic variables such as body composition measured by dual energy X-ray absorptiometry (DEXA), air displacement plethysmography, and abdominal computerized tomography (CT), insulin sensitivity measured by intravenous glucose tolerance test (IV-GTT) and metabolic rate measured by indirect calorimetry. Results from this study will expand our knowledge of the biology of obesity and weight regulation and may lead to targeted strategies for its treatment and control.

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

    Science.gov (United States)

    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…

  12. Twins eye study in Tasmania (TEST): rationale and methodology to recruit and examine twins.

    Science.gov (United States)

    Mackey, David A; Mackinnon, Jane R; Brown, Shayne A; Kearns, Lisa S; Ruddle, Jonathan B; Sanfilippo, Paul G; Sun, Cong; Hammond, Christopher J; Young, Terri L; Martin, Nicholas G; Hewitt, Alex W

    2009-10-01

    Visual impairment is a leading cause of morbidity and poor quality of life in our community. Unravelling the mechanisms underpinning important blinding diseases could allow preventative or curative steps to be implemented. Twin siblings provide a unique opportunity in biology to discover genes associated with numerous eye diseases and ocular biometry. Twins are particularly useful for quantitative trait analysis through genome-wide association and linkage studies. Although many studies involving twins rely on twin registries, we present our approach to the Twins Eye Study in Tasmania to provide insight into possible recruitment strategies, expected participation rates and potential examination strategies that can be considered by other researchers for similar studies. Five separate avenues for cohort recruitment were adopted: (1) piggy-backing existing studies where twins had been recruited, (2) utilizing the national twin registry, (3) word-of-mouth and local media publicity, (4) directly approaching schools, and finally (5) collaborating with other research groups studying twins.

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

    NARCIS (Netherlands)

    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

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

    NARCIS (Netherlands)

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

    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

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

    NARCIS (Netherlands)

    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

  16. Rationale and design of the Feeding Dynamic Intervention (FDI) study for self-regulation of energy intake in preschoolers.

    Science.gov (United States)

    Eneli, Ihuoma U; Tylka, Tracy L; Hummel, Jessica; Watowicz, Rosanna P; Perez, Susana A; Kaciroti, Niko; Lumeng, Julie C

    2015-03-01

    In 2011, the Institute of Medicine Early Childhood Prevention Policies Report identified feeding dynamics as an important focus area for childhood obesity prevention and treatment. Feeding dynamics includes two central components: (1) caregiver feeding practices (i.e., determining how, when, where, and what they feed their children) and (2) child eating behaviors (i.e., determining how much and what to eat from what food caregivers have provided). Although there has been great interest in overweight and obesity prevention and treatment in young children, they have not focused comprehensively on feeding dynamics. Interventions on feeding dynamics that reduce caregivers' excessive controlling and restrictive feeding practices and encourage the development of children's self-regulation of energy intake may hold promise for tackling childhood obesity especially in the young child but currently lack an evidence base. This manuscript describes the rationale and design for a randomized controlled trial designed to compare a group of mothers and their 3-to 5-year old children who received an intervention focused primarily on feeding dynamics called the Feeding Dynamic Intervention (FDI) with a Wait-list Control Group (WLC). The primary aim of the study will be to investigate the efficacy of the FDI for decreasing Eating in the Absence of Hunger (EAH) and improving energy compensation (COMPX). The secondary aim will be to examine the effect of the FDI in comparison to the WLC on maternal self-reported feeding practices and child satiety responsiveness.

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

    OpenAIRE

    Yam, P.S.; Morrison, R; Penpraze, V.; Westgarth, C.; D. S. Ward; Mutrie, N; Hutchison, P.; Young, D.; Reilly, J. J.

    2012-01-01

    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 interve...

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

    Science.gov (United States)

    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 offspring and many of their partners). The primary aims of the APrON study were to determine the relationships between maternal nutrient intake and status, before, during and after gestation, and (1) maternal mood; (2) birth and obstetric outcomes; and (3) infant neurodevelopment. We have collected comprehensive maternal nutrition, anthropometric, biological and mental health data at multiple points in the pregnancy and the post-partum period, as well as obstetrical, birth, health and neurodevelopmental outcomes of these pregnancies. The study continues to follow the infants through to 36 months of age. The current report describes the study design and methods, and findings of some pilot work. The APrON study is a significant resource with opportunities for collaboration.

  19. Rationale and Design of the Genomic Research in Alpha-1 Antitrypsin Deficiency and Sarcoidosis (GRADS) Study. Sarcoidosis Protocol.

    Science.gov (United States)

    Moller, David R; Koth, Laura L; Maier, Lisa A; Morris, Alison; Drake, Wonder; Rossman, Milton; Leader, Joseph K; Collman, Ronald G; Hamzeh, Nabeel; Sweiss, Nadera J; Zhang, Yingze; O'Neal, Scott; Senior, Robert M; Becich, Michael; Hochheiser, Harry S; Kaminski, Naftali; Wisniewski, Stephen R; Gibson, Kevin F

    2015-10-01

    Sarcoidosis is a systemic disease characterized by noncaseating granulomatous inflammation with tremendous clinical heterogeneity and uncertain pathobiology and lacking in clinically useful biomarkers. The Genomic Research in Alpha-1 Antitrypsin Deficiency and Sarcoidosis (GRADS) study is an observational cohort study designed to explore the role of the lung microbiome and genome in these two diseases. This article describes the design and rationale for the GRADS study sarcoidosis protocol. The study addresses the hypothesis that distinct patterns in the lung microbiome are characteristic of sarcoidosis phenotypes and are reflected in changes in systemic inflammatory responses as measured by peripheral blood changes in gene transcription. The goal is to enroll 400 participants, with a minimum of 35 in each of 9 clinical phenotype subgroups prioritized by their clinical relevance to understanding of the pathobiology and clinical heterogeneity of sarcoidosis. Participants with a confirmed diagnosis of sarcoidosis undergo a baseline visit with self-administered questionnaires, chest computed tomography, pulmonary function tests, and blood and urine testing. A research or clinical bronchoscopy with a research bronchoalveolar lavage will be performed to obtain samples for genomic and microbiome analyses. Comparisons will be made by blood genomic analysis and with clinical phenotypic variables. A 6-month follow-up visit is planned to assess each participant's clinical course. By the use of an integrative approach to the analysis of the microbiome and genome in selected clinical phenotypes, the GRADS study is powerfully positioned to inform and direct studies on the pathobiology of sarcoidosis, identify diagnostic or prognostic biomarkers, and provide novel molecular phenotypes that could lead to improved personalized approaches to therapy for sarcoidosis.

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

    DEFF Research Database (Denmark)

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

    2010-01-01

    Stroke is a major global health problem. It is the third leading cause of death and the leading cause of adult disability. INTERHEART, a global case-control study of acute myocardial infarction in 52 countries (29,972 participants), identified nine modifiable risk factors that accounted for >90% ...

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

    DEFF Research Database (Denmark)

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

    2002-01-01

    The European Prospective Investigation into Cancer and Nutrition (EPIC), which covers a large cohort of half a million men and women from 23 European centres in 10 Western European countries, was designed to study the relationship between diet and the risk of chronic diseases, particularly cancer...

  2. Why Communication Is Important: A Rationale for the Centrality of the Study of Communication.

    Science.gov (United States)

    Morreale, Sherwyn P.; Osborn, Michael M.; Pearson, Judy C.

    2000-01-01

    Presents annotations of articles, commentaries, and publications that emphasize the importance of communication and the role of the study of communication in contemporary life. Discusses six emergent themes. Concludes that communication education develops the whole person, improves the work of education, advances the interests of society, bridges…

  3. Rationale, design and methods of the HEALTHY study physical education intervention component

    Science.gov (United States)

    The HEALTHY primary prevention trial was designed to reduce risk factors for type 2 diabetes in middle school students. Middle schools at seven centers across the United States participated in the 3-year study. Half of them were randomized to receive a multi-component intervention. The intervention ...

  4. The Logic of School Gardens: A Phenomenological Study of Teacher Rationales

    Science.gov (United States)

    Jorgenson, Simon

    2013-01-01

    Despite the importance of teachers to the school garden movement, we still know very little about what drives particular teachers to incorporate a school garden into their pedagogy. In response, this article reports the findings of a study designed to investigate the internal processes and products involved in rationalising and sustaining…

  5. Rationale and protocol for using a smartphone application to study autism spectrum disorders: SMARTAUTISM

    Science.gov (United States)

    Bonnot, Olivier; Bonneau, Dominique; Doudard, Aude; Duverger, Philippe

    2016-01-01

    Introduction Longitudinal studies on the evolution of autism spectrum disorder (ASD) symptoms are limited and have primarily used repeated measurements performed several months apart. However, measurements of changes in everyday life should more closely reflect the ‘real life’ of the patient and his or her family. We propose to study the child's ASD symptoms and their effect on the quality of life, psychological status and anxiety of the child's parents over a 6-month period using SMARTAUTISM, a smartphone application. Method and analysis This is a prospective, longitudinal, exploratory, open study with a 6-month follow-up period. Data will be recorded longitudinally over multiple weeks under natural conditions. The factors affecting the quality of life and anxiety of parents of children with ASD and the children's functional symptoms will be examined, and the feasibility of using a smartphone application designed for parents of ASD patients will be assessed. Primary objective: Explore the evolution of a child's behaviour over 6 months and the (psychological and social) effects of these changes on the family. Secondary objective: Assess the feasibility of our application by examining the filling rate and application usage by parents for 6 months. 100 families containing 1 child diagnosed with ASD will be included. At baseline, sociodemographic, psychiatric and medical data will be recorded. The correlations of the general epidemiological variables (primary outcome measure) will be evaluated via multivariate analysis. The application filling rate (relative to the ideal filling rate) will be used to assess the feasibility of the application (secondary outcome measure). Ethics and dissemination The SMARTAUTISM study has the approval of the local ethics committee, and data security will be ensured via the use of encryption and a secure medical server. The use of this application will be proposed at autism resource centres across France. PMID:27881525

  6. Rationale, design and methods of the HEALTHY study nutrition intervention component.

    Science.gov (United States)

    Gillis, B; Mobley, C; Stadler, D D; Hartstein, J; Virus, A; Volpe, S L; El ghormli, L; Staten, M A; Bridgman, J; McCormick, S

    2009-08-01

    The HEALTHY study was a randomized, controlled, multicenter and middle school-based, multifaceted intervention designed to reduce risk factors for the development of type 2 diabetes. The study randomized 42 middle schools to intervention or control, and followed students from the sixth to the eighth grades. Here we describe the design of the HEALTHY nutrition intervention component that was developed to modify the total school food environment, defined to include the following: federal breakfast, lunch, after school snack and supper programs; a la carte venues, including snack bars and school stores; vending machines; fundraisers; and classroom parties and celebrations. Study staff implemented the intervention using core and toolbox strategies to achieve and maintain the following five intervention goals: (1) lower the average fat content of foods, (2) increase the availability and variety of fruits and vegetables, (3) limit the portion sizes and energy content of dessert and snack foods, (4) eliminate whole and 2% milk and all added sugar beverages, with the exception of low fat or nonfat flavored milk, and limit 100% fruit juice to breakfast in small portions and (5) increase the availability of higher fiber grain-based foods and legumes. Other nutrition intervention component elements were taste tests, cafeteria enhancements, cafeteria line messages and other messages about healthy eating, cafeteria learning laboratory (CLL) activities, twice-yearly training of food service staff, weekly meetings with food service managers, incentives for food service departments, and twice yearly local meetings and three national summits with district food service directors. Strengths of the intervention design were the integration of nutrition with the other HEALTHY intervention components (physical education, behavior change and communications), and the collaboration and rapport between the nutrition intervention study staff members and food service personnel at both school

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

    OpenAIRE

    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...

  8. Impact of Emerging Health Insurance Arrangements on Diabetes Outcomes and Disparities: Rationale and Study Design

    OpenAIRE

    Wharam, James Franklin; Soumerai, Steve; Trinacty, Connie; Eggleston, Emma; Zhang, Fang; LeCates, Robert F; Canning, Claire; Ross-Degnan, Dennis

    2013-01-01

    Consumer-directed health plans combine lower premiums with high annual deductibles, Internet-based quality-of-care information, and health savings mechanisms. These plans may encourage members to seek better value for health expenditures but may also decrease essential care. The expansion of high-deductible health plans (HDHPs) represents a natural experiment of tremendous proportion. We designed a pre–post, longitudinal, quasi-experimental study to determine the effect of HDHPs on diabetes q...

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

    Directory of Open Access Journals (Sweden)

    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. The Cooperative Health Research in South Tyrol (CHRIS) study: rationale, objectives, and preliminary results.

    Science.gov (United States)

    Pattaro, Cristian; Gögele, Martin; Mascalzoni, Deborah; Melotti, Roberto; Schwienbacher, Christine; De Grandi, Alessandro; Foco, Luisa; D'Elia, Yuri; Linder, Barbara; Fuchsberger, Christian; Minelli, Cosetta; Egger, Clemens; Kofink, Lisa S; Zanigni, Stefano; Schäfer, Torsten; Facheris, Maurizio F; Smárason, Sigurður V; Rossini, Alessandra; Hicks, Andrew A; Weiss, Helmuth; Pramstaller, Peter P

    2015-11-05

    The Cooperative Health Research In South Tyrol (CHRIS) study is a population-based study with a longitudinal lookout to investigate the genetic and molecular basis of age-related common chronic conditions and their interaction with life style and environment in the general population. All adults of the middle and upper Vinschgau/Val Venosta are invited, while 10,000 participants are anticipated by mid-2017. Family participation is encouraged for complete pedigree reconstruction and disease inheritance mapping. After a pilot study on the compliance with a paperless assessment mode, computer-assisted interviews have been implemented to screen for conditions of the cardiovascular, endocrine, metabolic, genitourinary, nervous, behavioral, and cognitive system. Fat intake, cardiac health, and tremor are assessed instrumentally. Nutrient intake, physical activity, and life-course smoking are measured semi-quantitatively. Participants are phenotyped for 73 blood and urine parameters and 60 aliquots per participant are biobanked (cryo-preserved urine, DNA, and whole and fractionated blood). Through liquid-chromatography mass-spectrometry analysis, metabolite profiling of the mitochondrial function is assessed. Samples are genotyped on 1 million variants with the Illumina HumanOmniExpressExome array and the first data release including 4570 fully phenotyped and genotyped samples is now available for analysis. Participants' follow-up is foreseen 6 years after the first visit. The target population is characterized by long-term social stability and homogeneous environment which should both favor the identification of enriched genetic variants. The CHRIS cohort is a valuable resource to assess the contribution of genomics, metabolomics, and environmental factors to human health and disease. It is awaited that this will result in the identification of novel molecular targets for disease prevention and treatment.

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

    Directory of Open Access Journals (Sweden)

    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

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

    DEFF Research Database (Denmark)

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

    2010-01-01

    Stroke is a major global health problem. It is the third leading cause of death and the leading cause of adult disability. INTERHEART, a global case-control study of acute myocardial infarction in 52 countries (29,972 participants), identified nine modifiable risk factors that accounted for >90...... 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 age (+/-5...

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

    Directory of Open Access Journals (Sweden)

    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

  14. Impact of emerging health insurance arrangements on diabetes outcomes and disparities: rationale and study design.

    Science.gov (United States)

    Wharam, J Frank; Soumerai, Steve; Trinacty, Connie; Eggleston, Emma; Zhang, Fang; LeCates, Robert; Canning, Claire; Ross-Degnan, Dennis

    2013-01-01

    Consumer-directed health plans combine lower premiums with high annual deductibles, Internet-based quality-of-care information, and health savings mechanisms. These plans may encourage members to seek better value for health expenditures but may also decrease essential care. The expansion of high-deductible health plans (HDHPs) represents a natural experiment of tremendous proportion. We designed a pre-post, longitudinal, quasi-experimental study to determine the effect of HDHPs on diabetes quality of care, outcomes, and disparities. We will use a 13-year rolling sample (2001-2013) of members of an HDHP and members of a control group. To reduce selection bias, we will limit participants to those whose employers mandate a single health insurance type. The study will measure rates of monthly hemoglobin A1c, lipid, and albuminuria testing; availability of blood glucose test strips; and rates of retinal examinations, high-severity emergency department visits, and preventable hospitalizations. Results could be used to design health plan features that promote high-quality care and better outcomes among people who have diabetes.

  15. Hypertrophic Cardiomyopathy Registry: The rationale and design of an international, observational study of hypertrophic cardiomyopathy.

    Science.gov (United States)

    Kramer, Christopher M; Appelbaum, Evan; Desai, Milind Y; Desvigne-Nickens, Patrice; DiMarco, John P; Friedrich, Matthias G; Geller, Nancy; Heckler, Sarahfaye; Ho, Carolyn Y; Jerosch-Herold, Michael; Ivey, Elizabeth A; Keleti, Julianna; Kim, Dong-Yun; Kolm, Paul; Kwong, Raymond Y; Maron, Martin S; Schulz-Menger, Jeanette; Piechnik, Stefan; Watkins, Hugh; Weintraub, William S; Wu, Pan; Neubauer, Stefan

    2015-08-01

    Hypertrophic cardiomyopathy (HCM) is the most common monogenic heart disease with a frequency as high as 1 in 200. In many cases, HCM is caused by mutations in genes encoding the different components of the sarcomere apparatus. Hypertrophic cardiomyopathy is characterized by unexplained left ventricular hypertrophy, myofibrillar disarray, and myocardial fibrosis. The phenotypic expression is quite variable. Although most patients with HCM are asymptomatic, serious consequences are experienced in a subset of affected individuals who present initially with sudden cardiac death or progress to refractory heart failure. The Hypertrophic Cardiomyopathy Registry study is a National Heart, Lung, and Blood Institute-sponsored 2,750-patient, 44-site, international registry and natural history study designed to address limitations in extant evidence to improve prognostication in HCM (NCT01915615). In addition to the collection of standard demographic, clinical, and echocardiographic variables, patients will undergo state-of-the-art cardiac magnetic resonance for assessment of left ventricular mass and volumes as well as replacement scarring and interstitial fibrosis. In addition, genetic and biomarker analyses will be performed. The Hypertrophic Cardiomyopathy Registry has the potential to change the paradigm of risk stratification in HCM, using novel markers to identify those at higher risk.

  16. Design, rationale, and baseline demographics of SEARCH I: a prospective cluster-randomized study

    Directory of Open Access Journals (Sweden)

    Albers F

    2012-07-01

    Full Text Available Frank Albers,1 Asif Shaikh,2 Ahmar Iqbal,31Medical Affairs Respiratory, 2Clinical Development and Medical Affairs, Field Based Medicine-Respiratory, Boehringer Ingelheim Pharmaceuticals, Inc, Ridgefield, CT, USA; 3Respiratory Medical Affairs, Pfizer Inc, New York, NY, USAAbstract: Questionnaires are available to identify patients at risk for several chronic diseases, including COPD, but are infrequently utilized in primary care. COPD is often underdiagnosed, while at the same time the US Preventive Services Task Force recommends against spirometric screening for COPD in asymptomatic adults. Use of a symptom-based questionnaire and subsequent handheld spirometric device depending on the answers to the questionnaire is a promising approach to identify patients at risk for COPD. Screening, Evaluating and Assessing Rate CHanges of diagnosing respiratory conditions in primary care 1 (SEARCH I was a prospective cluster-randomized study in 168 US primary care practices evaluating the effect of the COPD-Population Screener (COPD-PS™ questionnaire. The effect of this questionnaire alone or sequentially with the handheld copd-6TM device was evaluated on new diagnoses of COPD and on respiratory diagnostic practice patterns (including referrals for pulmonary function testing, referrals to pulmonologists, new diagnoses of COPD, and new respiratory medication prescriptions. Participating practices entered a total of 9704 consecutive consenting subjects aged ≥ 40 years attending primary care clinics. Study arm results were compared for new COPD diagnosis rates between usual care and (1 COPD-PS plus copd-6 and (2 COPD-PS alone. A cluster-randomization design allowed comparison of the intervention effects at the practice level instead of individuals being the subjects of the intervention. Regional principal investigators controlled the flow of study information to sub-investigators at participating practices to reduce observation bias (Hawthorne effect. The

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

    DEFF Research Database (Denmark)

    Parving, Hans-Henrik; Brenner, Barry M; McMurray, John J V;

    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...... the 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...

  18. Relationship between volition, physical activity and weight loss maintenance: Study rationale, design, methods and baseline characteristics

    DEFF Research Database (Denmark)

    Jørgensen, Sune Dandanell; Elbe, Anne-Marie; Pfister, Gertrud Ursula

    2017-01-01

    ) for an interdisciplinary prospective study with follow-up. The change in lifestyle and weight loss is promoted via a 3-month intensive lifestyle intervention at a private health school. The intervention consists of supervised training (1–3 hours/day), a healthy hypo-caloric diet (−500 to −700 kCal/day) and education...... in healthy lifestyle in classes/groups. The participants’ body weight and composition (Dual Energy X-ray absorptiometry), volitional skills (questionnaire), physical activity level (heart rate accelerometer / questionnaire) and maximal oxygen uptake (indirect calorimetry) are to be monitored before, after...... maintenance. Conclusions: If specific volitional skills are identified as predictors of adherence to physical activity and success in clinical weight loss maintenance, these can be trained in future intensive lifestyle interventions in order to optimize the success rate....

  19. A family smoking index to capture genetic influence in smoking: rationale and two validation studies.

    Science.gov (United States)

    Drobes, David J; Munafò, Marcus R; Leigh, Fiona; Saladin, Michael E

    2005-02-01

    Despite a growing appreciation that genetic factors may impart vulnerability toward smoking behavior, only a modest consensus has been created about the specific genetic mechanisms that may underlie various aspects of smoking. A core feature of genetic contribution toward any complex human behavior is familial resemblance. Most previous attempts to index familial smoking have classified individuals into discrete categories, based on the number of smokers in a family. We discuss the development of a continuous measure of familial smoking, the Family Smoking Index (FSI), which is based on the proportion of smokers in first- and second-degree family members and provides a more precise weighting according to genetic proximity. We present the psychometric characteristics of the FSI as well as initial validation data from two studies. We also describe current and future directions for continued FSI validation and application.

  20. Neuroimaging studies of factors related to exercise: rationale and design of a 9 month trial.

    Science.gov (United States)

    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; Savage, Cary R

    2014-01-01

    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), include reward processing and cognitive control regions. A 9 month aerobic exercise study will be conducted in 180 sedentary adults (n = 90 healthy weight [BMI = 18.5 to 26.0 kg/m(2)]; n = 90 obese [BMI = 29.0 to 41.0 kg/m(2)) to examine the brain processes underlying reward processing and impulse control that may affect adherence in a new exercise regimen. The primary aim is to use functional magnetic resonance imaging (fMRI) to examine reward processing and impulse control among participants that adhere (exercise >80% of sessions) and those that do not adhere to a nine-month exercise intervention with secondary analyses comparing sedentary obese and sedentary healthy weight participants. Our results will provide valuable information characterizing brain activation underlying reward processing and impulse control in sedentary obese and healthy weight individuals. In addition, our results may identify brain activation predictors of adherence and success in the exercise program along with measuring the effects of exercise and improved fitness on brain activation.

  1. The Congenital Heart Disease Genetic Network Study: rationale, design, and early results.

    Science.gov (United States)

    Gelb, Bruce; Brueckner, Martina; Chung, Wendy; Goldmuntz, Elizabeth; Kaltman, Jonathan; Kaski, Juan Pablo; Kim, Richard; Kline, Jennie; Mercer-Rosa, Laura; Porter, George; Roberts, Amy; Rosenberg, Ellen; Seiden, Howard; Seidman, Christine; Sleeper, Lynn; Tennstedt, Sharon; Kaltman, Jonathan; Schramm, Charlene; Burns, Kristin; Pearson, Gail; Rosenberg, Ellen

    2013-02-15

    Congenital heart defects (CHD) are the leading cause of infant mortality among birth defects, and later morbidities and premature mortality remain problematic. Although genetic factors contribute significantly to cause CHD, specific genetic lesions are unknown for most patients. The National Heart, Lung, and Blood Institute-funded Pediatric Cardiac Genomics Consortium established the Congenital Heart Disease Genetic Network Study to investigate relationships between genetic factors, clinical features, and outcomes in CHD. The Pediatric Cardiac Genomics Consortium comprises 6 main and 4 satellite sites at which subjects are recruited, and medical data and biospecimens (blood, saliva, cardiovascular tissue) are collected. Core infrastructure includes an administrative/data-coordinating center, biorepository, data hub, and core laboratories (genotyping, whole-exome sequencing, candidate gene evaluation, and variant confirmation). Eligibility includes all forms of CHD. Annual follow-up is obtained for probands age is 5.5 years. The one third enrolled at age <1 year are contacted annually for follow-up information. The distribution of CHD favors more complex lesions. Approximately, 11% of probands have a genetic diagnosis. Adequate DNA is available from 97% and 91% of blood and saliva samples, respectively. Genomic analyses of probands with heterotaxy, atrial septal defects, conotruncal, and left ventricular outflow tract obstructive lesions are underway. The scientific community's use of Pediatric Cardiac Genomics Consortium resources is welcome.

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

    Science.gov (United States)

    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.

  3. PROspective Multicenter Imaging Study for Evaluation of Chest Pain: Rationale and Design of the PROMISE Trial

    Science.gov (United States)

    Douglas, Pamela S.; Hoffmann, Udo; Lee, Kerry L.; Mark, Daniel B.; Al-Khalidi, Hussein R.; Anstrom, Kevin; Dolor, Rowena J.; Kosinski, Andrzej; Krucoff, Mitchell W.; Mudrick, Daniel W.; Patel, Manesh R.; Picard, Michael H.; Udelson, James E.; Velazquez, Eric J.; Cooper, Lawton

    2014-01-01

    Background Suspected coronary artery disease (CAD) is one of the most common, potentially life threatening diagnostic problems clinicians encounter. However, no large outcome-based randomized trials have been performed to guide the selection of diagnostic strategies for these patients. Methods The PROMISE study is a prospective, randomized trial comparing the effectiveness of two initial diagnostic strategies in patients with symptoms suspicious for CAD. Patients are randomized to either: 1) functional testing (exercise electrocardiogram, stress nuclear imaging, or stress echocardiogram); or 2) anatomic testing with >=64 slice multidetector coronary computed tomographic angiography. Tests are interpreted locally in real time by subspecialty certified physicians and all subsequent care decisions are made by the clinical care team. Sites are provided results of central core lab quality and completeness assessment. All subjects are followed for ≥1 year. The primary end-point is the time to occurrence of the composite of death, myocardial infarction, major procedural complications (stroke, major bleeding, anaphylaxis and renal failure) or hospitalization for unstable angina. Results Over 10,000 symptomatic subjects were randomized in 3.2 years at 193 US and Canadian cardiology, radiology, primary care, urgent care and anesthesiology sites. Conclusion Multi-specialty community practice enrollment into a large pragmatic trial of diagnostic testing strategies is both feasible and efficient. PROMISE will compare the clinical effectiveness of an initial strategy of functional testing against an initial strategy of anatomic testing in symptomatic patients with suspected CAD. Quality of life, resource use, cost effectiveness and radiation exposure will be assessed. Clinical trials.gov identifier NCT01174550 PMID:24890527

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

    DEFF Research Database (Denmark)

    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...

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

    Energy Technology Data Exchange (ETDEWEB)

    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

  6. A case for consideration of cultural diversity in heart failure management--Part 1: Rationale for the DISCOVER Study.

    Science.gov (United States)

    Davidson, Patricia M; Macdonald, Peter; Ang, Esther; Paull, Glenn; Choucair, Sam; Daly, John; Moser, Debra K; Dracup, Kathleen

    2004-10-01

    Heart failure is a condition increasing in prevalence and responsible for high health care utilization, morbidity and mortality. Randomised controlled trials of nurse-coordinated interventions have determined self-care and the incorporation of the patient and their family in care planning as critical elements of service delivery. Coping with a chronic illness, such as heart failure, forces the individual to adjust to changed physical, social and emotional functioning and to modify their lifestyle accordingly. Clinicians increasingly use models of care that focus care delivery on the community setting. In order to develop strategies to assist patients and their families with self-care it is important that clinicians understand the health-care seeking behaviours of all individuals targeted in the community. Australia is a culturally diverse nation, yet evaluations of models of care have been undertaken largely in individuals from predominately Anglo-Celtic origins. The end result of this approach is failure to understand the full range of diverse perspectives that individuals hold that can have an impact on self-care behaviours. Consideration of cultural diversity should extend beyond language to a broader appreciation of cultural values, health seeking beliefs and engagement of culturally unique communities. The 'Understanding the cultural experiences of individuals with chronic heart failure (CHF) in South East Health (DISCOVER) Study' seeks to uncover information on the health patterns, information needs and the adjustment process for overseas-born individuals with heart failure. Such information will assist clinicians to tailor health care service delivery and ensure the delivery of appropriate, quality care. This manuscript provides the background, rationale and methods for this study.

  7. A retrospective cohort study of cancer mortality in employees of a Russian chrysotile asbestos mine and mills: study rationale and key features.

    Science.gov (United States)

    Schüz, J; Schonfeld, S J; Kromhout, H; Straif, K; Kashanskiy, S V; Kovalevskiy, E V; Bukhtiyarov, I V; McCormack, V

    2013-08-01

    Chrysotile, a serpentine asbestos fibre, is the only type of asbestos produced and consumed in the world today. It is an established human carcinogen. We have begun fieldwork on a retrospective cohort study of employees of one of the world's largest chrysotile mine and mills, situated in Asbest, Russia. The primary aim of the study is to better characterize and quantify the risk of cancer mortality in terms of (i) the dose-response relationship of exposure with risk; (ii) the range of cancer sites affected, including female-specific cancers; and (iii) effects of duration of exposure and latency periods. This information will expand our understanding of the scale of the impending cancer burden due to chrysotile, including if chrysotile use ceased worldwide forthwith. Herein we describe the scientific rationale for conducting this study and the main features of its study design.

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

    Directory of Open Access Journals (Sweden)

    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

  9. Rationale, design, methodology and sample characteristics for the family partners for health study: a cluster randomized controlled study

    Directory of Open Access Journals (Sweden)

    Berry Diane C

    2012-03-01

    Full Text Available Abstract Background Young children who are overweight are at increased risk of becoming obese and developing type 2 diabetes and cardiovascular disease later in life. Therefore, early intervention is critical. This paper describes the rationale, design, methodology, and sample characteristics of a 5-year cluster randomized controlled trial being conducted in eight elementary schools in rural North Carolina, United States. Methods/Design The first aim of the trial is to examine the effects of a two-phased intervention on weight status, adiposity, nutrition and exercise health behaviors, and self-efficacy in overweight or obese 2nd, 3 rd, and 4th grade children and their overweight or obese parents. The primary outcome in children is stabilization of BMI percentile trajectory from baseline to 18 months. The primary outcome in parents is a decrease in BMI from baseline to 18 months. Secondary outcomes for both children and parents include adiposity, nutrition and exercise health behaviors, and self-efficacy from baseline to 18 months. A secondary aim of the trial is to examine in the experimental group, the relationships between parents and children's changes in weight status, adiposity, nutrition and exercise health behaviors, and self-efficacy. An exploratory aim is to determine whether African American, Hispanic, and non-Hispanic white children and parents in the experimental group benefit differently from the intervention in weight status, adiposity, health behaviors, and self-efficacy. A total of 358 African American, non-Hispanic white, and bilingual Hispanic children with a BMI ≥ 85th percentile and 358 parents with a BMI ≥ 25 kg/m2 have been inducted over 3 1/2 years and randomized by cohort to either an experimental or a wait-listed control group. The experimental group receives a 12-week intensive intervention of nutrition and exercise education, coping skills training and exercise (Phase I, 9 months of continued monthly contact

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

    Energy Technology Data Exchange (ETDEWEB)

    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.

  11. Significance of Haemodynamic and Haemostatic Factors in the Course of Different Manifestations of Cerebral Small Vessel Disease: The SHEF-CSVD Study—Study Rationale and Protocol

    Directory of Open Access Journals (Sweden)

    Jacek Staszewski

    2013-01-01

    Full Text Available Rationale. This paper describes the rationale and design of the SHEF-CSVD Study, which aims to determine the long-term clinical and radiological course of cerebral small vessel disease (CSVD and to evaluate haemostatic and haemodynamic prognostic factors of the condition. Design. This single-centre, prospective, non-interventional cohort study will follow 150 consecutive patients with different clinical manifestations of CSVD (lacunar ischaemic stroke, vascular dementia, vascular parkinsonism or spontaneous deep, intracerebral haemorrhage and 50 age- and sex-matched controls over a period of 24 months. The clinical and radiological course will be evaluated basing on a detailed neurological, neuropsychological and MRI examinations. Haemodynamic (cerebral vasoreactivity, 24 h blood pressure control and haemostatic factors (markers of endothelial and platelet dysfunction, brachial artery flow-mediated dilatation test will be determined. Discussion. The scheduled study will specifically address the issue of haemodynamic and haemostatic prognostic factors and their course over time in various clinical manifestations of CSVD. The findings may aid the development of prophylactic strategies and individualised treatment plans, which are critical during the early stages of the disease.

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

    Directory of Open Access Journals (Sweden)

    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.

  13. Home versus Office blood pressure MEasurements : Reduction of Unnecessary treatment Study: Rationale and Study design of the HOMERUS Trial

    NARCIS (Netherlands)

    Verberk, WJ; Kroon, AA; Kessels, AGH; Dirksen, C; Nelemans, PJ; Lenders, JWM; Thien, TABM; van Montfrans, GA; Smit, AJ; de Leeuw, PW

    2003-01-01

    The Home versus Office MEasurements, Reduction of Unnecessary treatment Study (HOMERUS) is a multicentre prospective study, primarily designed to examine in subjects with mild to moderate hypertension whether treatment decisions based on home blood pressure measurements can lead to reduction in the

  14. Population-based multicase-control study in common tumors in Spain (MCC-Spain: rationale and study design

    Directory of Open Access Journals (Sweden)

    Gemma Castaño-Vinyals

    2015-07-01

    Discussion: This study, conducted within the Spanish Consortium for Biomedical Research in Epidemiology & Public Health (CIBERESP, is a unique initiative to evaluate etiological factors for common cancers and will promote cancer research and prevention in Spain.

  15. Case study research as bridge builder between science and the society. The rationale behind the ASTRA 2005 winter storm study

    Energy Technology Data Exchange (ETDEWEB)

    Haanpaeae, S.; Peltonen, L.

    2007-07-01

    The challenge of climate change as a complex global issue is that it demands locally grounded solutions that bring together actors from various fields. As a 'wicked' problem climate change adaptation demands deliberation between different subsystems of society, including scientific research. While answering the complex needs of the society, it has to be re-evaluated what 'good' science means. This brings about a need for socially robust knowledge. The need for contextualisation of scientific knowledge is supported by theoretical development in the fields of policy analysis and risk governance. It also entails an epistemic shift away from the 'quest for certainty' towards a pragmatist understanding of knowledge. The underlying request is to integrate expert knowledge with the needs of other stakeholders - to bring in the people to add to the policy formation a notion of emotional knowledge. As a research method, case studies readily contextualise scientific information and therefore offer valuable insights into the underlying social values of the problems at hand. As locally grounded narratives they can offer a shortcut to the formation of a new kind of expertise needed as the demands from the society reform the claims on scientific information. It is argued that developing the science-policy interface and risk communication can both benefit from a contextual research approach using case studies. Such studies have critical and persuasive functions, and they provide a basis for further case-based learning exercises with opportunities for awareness raising, institutional capacity building and practical adaptation measures. (orig.)

  16. Rationale and design of a study using a standardized locally procured macronutrient supplement as adjunctive therapy to HIV treatment in Kenya.

    Science.gov (United States)

    Sztam, Kevin A; Ndirangu, Murugi; Sheriff, Muhsin; Arpadi, Stephen M; Hawken, Mark; Rashid, Juma; Deckelbaum, Richard J; El Sadr, Wafaa M

    2013-01-01

    Poor nutritional status at initiation of antiretroviral therapy (ART) is predictive of mortality. Decreased dietary intake is a major determinant of weight loss in HIV. Despite a biological rationale to treat undernutrition in adults receiving ART, few studies have provided data on feasibility, safety, effectiveness, and sustainability of specific macronutrient supplements with HIV treatment in adults, especially supplements such as a food basket, a supplement approach seldom evaluated in spite of its wide use. We present the rationale and design for a study of a locally procured macronutrient supplement given to HIV-infected patients initiating ART with a body mass index (BMI) ≤20.0 kg/m(2). The objective was to determine feasibility of procurement, distribution, safety and to obtain preliminary effectiveness data for a locally procured supplement. The design was a comparative study for 200 adult participants at two Kenya government-supported clinics. The primary outcome was BMI at 24 weeks. Supplement duration was 24 weeks, total follow-up was 48 weeks, and the study included a comparison site. Novel aspects of this study include use of a standardized macronutrient supplement to protect the participant against household food sharing, and a complementary micronutrient supplement. Comprehensive data collected included dietary intake, HIV-related quality-of-life, food security, neuropsychiatric assessments, laboratory studies, and household geomapping. Assessments were made at baseline, at 24 weeks, and at 48 weeks post-ART initiation. Challenges included establishing a partnership with local millers, distribution from the HIV clinic, food safety, and tracking of participants. These findings will help inform nutrition support programming in Kenya and similar settings, and provide needed data regarding use of macronutrient supplements as an adjunctive intervention with ART.

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

    Directory of Open Access Journals (Sweden)

    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

  18. Rationale for Student Dress Codes: A Review of School Handbooks

    Science.gov (United States)

    Freeburg, Elizabeth W.; Workman, Jane E.; Lentz-Hees, Elizabeth S.

    2004-01-01

    Through dress codes, schools establish rules governing student appearance. This study examined stated rationales for dress and appearance codes in secondary school handbooks; 182 handbooks were received. Of 150 handbooks containing a rationale, 117 related dress and appearance regulations to students' right to a non-disruptive educational…

  19. Rationale Management Challenges in Requirements Engineering

    NARCIS (Netherlands)

    Liang, Peng; Avgeriou, Paris; He, Keqing

    2010-01-01

    Rationale and rationale management have been playing an increasingly prominent role in software system development mainly due to the knowledge demand during system evaluation, maintenance, and evolution, especially for large and complex systems. The rationale management for requirements engineering,

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

    Directory of Open Access Journals (Sweden)

    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

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

    Directory of Open Access Journals (Sweden)

    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.

  2. Design and rationale of the HCC BRIDGE study in China: a longitudinal, multicenter cohort trial in hepatocellular carcinoma

    Directory of Open Access Journals (Sweden)

    Qiao You-Lin

    2011-05-01

    Full Text Available Abstract Background More than 50% of the worldwide cases of hepatocellular carcinoma occur in China, and this malignancy currently represents the country's second leading cause of cancer death in cities and the leading cause in rural areas. Despite recent advances in the control and management of hepatocellular carcinoma within China, this disease remains a major health care issue. The global HCC BRIDGE study, designed to assess patterns of hepatocellular carcinoma therapy use and associated outcomes across real-world clinical practice, has recently been expanded as a national study in China, allowing a detailed analysis of hepatocellular carcinoma in this important country. Methods/Design The global HCC BRIDGE study is a multiregional longitudinal cohort trial including patients newly diagnosed with hepatocellular carcinoma between January 1, 2005, and June 30, 2011, who are receiving treatment for hepatocellular carcinoma via sites in the Asia-Pacific, European, and North American regions. The HCC BRIDGE China national study comprises the portion of the global HCC BRIDGE study conducted within mainland China. Patients will be followed from time of diagnosis of hepatocellular carcinoma (post-January 1, 2005 to time of death or December 31, 2011, whichever comes first. Data will be collected on demographic/clinical characteristics, relevant laboratory values, hepatocellular carcinoma/underlying liver disease treatment, tumor response, adverse events, hospitalizations, and overall survival. The primary study end point is overall survival; secondary end points are disease progression, treatment-limiting adverse events, and treatment failure. Results At the time of writing, 15 sites have selected for participation across all 7 traditional regions of China (North, North-East, East, South, South-West, North-West, and Central. The anticipated study population from the China national study is approximately 9000 patients. Discussion Findings from the

  3. Impact of integrated upper limb spasticity management including botulinum toxin A on patient-centred goal attainment:rationale and protocol for an international, prospective, longitudinal cohort study (ULIS III)

    OpenAIRE

    Turner-Stokes, Lynne Frances; Ashford, Stephen; Jacinto, Jorge; Maisonobe, Pascal; Balcaitiene, Jovita; Fheodoroff, Klemens

    2016-01-01

    OBJECTIVES: Describe the rationale and protocol for the Upper Limb International Spasticity (ULIS)-III study, which aims to evaluate the impact of integrated spasticity management, involving multiple botulinum toxin A (BoNT-A) injection cycles and concomitant therapies, on patient-centred goal attainment. Outline novel outcome assessment methods for ULIS-III and report initial evaluation data from goal setting in early stages of the study.DESIGN: Large international longitudinal cohort study ...

  4. Design and rationale for RE-VERSE AD : A phase 3 study of idarucizumab, a specific reversal agent for dabigatran

    NARCIS (Netherlands)

    Pollack, Charles V.; Reilly, Paul A.; Bernstein, Richard; Dubiel, Robert; Eikelboom, John; Glund, Stephan; Huisman, Menno V.; Hylek, Elaine; Kam, Chak-Wah; Kamphuisen, Pieter W.; Kreuzer, Joerg; Levy, Jerrold H.; Sellke, Frank; Stangier, Joachim; Steiner, Thorsten; Wang, Bushi; Weitz, Jeffrey I.

    2015-01-01

    Idarucizumab, a Fab fragment directed against dabigatran, produced rapid and complete reversal of the anticoagulation effect of dabigatran in animals and in healthy volunteers. The Study of the REVERSal Effects of Idarucizumab in Patients on Active Dabigatran (RE-VERSE AD (TM)) is a global phase 3 p

  5. Rationale, design, and baseline characteristics of the Canagliflozin Cardiovascular Assessment Study (CANVAS)-A randomized placebo-controlled trial

    NARCIS (Netherlands)

    Neal, Bruce; Perkovic, Vlado; de Zeeuw, Dick; Mahaffey, Kenneth W.; Fulcher, Greg; Stein, Peter; Desai, Mehul; Shaw, Wayne; Jiang, Joel; Vercruysse, Frank; Meininger, Gary; Matthews, David

    2013-01-01

    Sodium glucose co-transporter 2 inhibition is a novel mode of treatment for type 2 diabetes mellitus (T2DM). The sodium glucose co-transporter 2 inhibitor canagliflozin lowered blood glucose, blood pressure, and body weight, with increased risk of urogenital infections in Phase 2 studies. Effects on

  6. Occipital nerve stimulation in medically intractable, chronic cluster headache. The ICON study: Rationale and protocol of a randomised trial

    NARCIS (Netherlands)

    Wilbrink, Leopoldine A.; Teernstra, Onno P.M.; Haan, Joost; Zwet, van Erik W.; Evers, Silvia M.A.A.; Spincemaille, Geert H.; Veltink, Peter H.; Mulleners, Wim; Brand, Ronald; Huygen, Frank J.P.M.; Jensen, Rigmor H.; Paemeleire, Koen; Goadsby, Peter J.; Visser-Vandewalle, Veerle; Ferrari, Michel D.

    2013-01-01

    Background: About 10% of cluster headache patients have the chronic form. At least 10% of this chronic group is intractable to or cannot tolerate medical treatment. Open pilot studies suggest that occipital nerve stimulation (ONS) might offer effective prevention in these patients. Controlled neurom

  7. Effect of trans fatty acid isomers from ruminant sources on risk factors of cardiovascular disease: study design and rationale.

    Science.gov (United States)

    Gebauer, Sarah K; Destaillats, Frederic; Mouloungui, Zéphirin; Candy, Laure; Bezelgues, Jean-Baptiste; Dionisi, Fabiola; Baer, David J

    2011-07-01

    Substantial evidence clearly demonstrates the deleterious effects of industrially-produced trans fatty acids (TFA); however, data are lacking from large, well controlled human feeding studies that directly compare the effects of industrially-produced and naturally-occurring TFA. The purpose of the current study is to determine whether consumption of TFA derived from different sources differentially affect risk factors of cardiovascular disease (CVD). The study was a randomized, crossover design, controlled-feeding intervention designed to compare the effects of the following diet treatments on risk factors of CVD: low TFA diet (base diet, 34% energy from fat; 0.1% energy from TFA), base diet with vaccenic acid (3.0% energy), base diet with mixed isomers of TFA from partially hydrogenated vegetable oil (3.0% energy), and base diet with cis-9, trans-11 CLA (1.0% energy). The added energy from TFA replaced energy from stearic acid. Participants were required to be between the ages of 25 and 65 years, have a body mass index between 20 and 38 kg/m(2), total cholesterol affect markers of cardiovascular risk, in the context of a highly controlled feeding study.

  8. Prosthetic valves in adult patients with congenital heart disease : Rationale and design of the Dutch PROSTAVA study

    NARCIS (Netherlands)

    Freling, H. G.; van Slooten, Y. J.; van Melle, J. P.; Mulder, B. J. M.; van Dijk, A. P. J.; Hillege, H. L.; Post, M. C.; Sieswerda, G. Tj; Jongbloed, M. R. M.; Willems, T. P.; Pieper, P. G.

    2012-01-01

    Data on long-term complications in adult patients with congenital heart disease (ACHD) and a prosthetic valve are scarce. Moreover, the influence of prosthetic valves on quality of life (QoL) and functional outcome in ACHD patients with prosthetic valves has not been studied. The primary objective o

  9. Prosthetic valves in adult patients with congenital heart disease: Rationale and design of the Dutch PROSTAVA study

    NARCIS (Netherlands)

    Freling, H.G.; Slooten, Y.J. van; Melle, J.P. van; Mulder, B.J.; Dijk, A.P. van; Hillege, H.L.; Post, M.C.; Sieswerda, G.T.; Jongbloed, M.R.; Willems, T.P.; Pieper, P.G.

    2012-01-01

    BACKGROUND: Data on long-term complications in adult patients with congenital heart disease (ACHD) and a prosthetic valve are scarce. Moreover, the influence of prosthetic valves on quality of life (QoL) and functional outcome in ACHD patients with prosthetic valves has not been studied. OBJECTIVES:

  10. Markers of achievement for assessing and monitoring gender equity in translational research organisations: a rationale and study protocol

    Science.gov (United States)

    Edmunds, Laurel D; Pololi, Linda H; Greenhalgh, Trisha; Kiparoglou, Vasiliki; Henderson, Lorna R; Williamson, Catherine; Grant, Jonathan; Lord, Graham M; Channon, Keith M; Lechler, Robert I; Buchan, Alastair M

    2016-01-01

    Introduction Translational research organisations (TROs) are a core component of the UK's expanding research base. Equity of career opportunity is key to ensuring a diverse and internationally competitive workforce. The UK now requires TROs to demonstrate how they are supporting gender equity. Yet, the evidence base for documenting such efforts is sparse. This study is designed to inform the acceleration of women's advancement and leadership in two of the UK's leading TROs—the National Institute for Health Research (NIHR) Biomedical Research Centres (BRCs) in Oxford and London—through the development, application and dissemination of a conceptual framework and measurement tool. Methods and analysis A cross-sectional retrospective evaluation. A conceptual framework with markers of achievement and corresponding candidate metrics has been specifically designed for this study based on an adapted balanced scorecard approach. It will be refined with an online stakeholder consultation and semistructured interviews to test the face validity and explore practices and mechanisms that influence gender equity in the given settings. Data will be collected via the relevant administrative databases. A comparison of two funding periods (2007–2012 and 2012–2017) will be carried out. Ethics and dissemination The University of Oxford Clinical Trials and Research Governance Team and the Research and Development Governance Team of Guy's and St Thomas’ National Health Service (NHS) Foundation Trust reviewed the study and deemed it exempt from full ethics review. The results of the study will be used to inform prospective planning and monitoring within the participating NIHR BRCs with a view to accelerating women's advancement and leadership. Both the results of the study and its methodology will be further disseminated to academics and practitioners through the networks of collaborating TROs, relevant conferences and articles in peer-reviewed journals. PMID:26743702

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

    Directory of Open Access Journals (Sweden)

    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.

  12. The Prevention of Early Asthma in Kids study: design, rationale and methods for the Childhood Asthma Research and Education network.

    Science.gov (United States)

    Guilbert, Theresa W; Morgan, Wayne J; Krawiec, Marzena; Lemanske, Robert F; Sorkness, Chris; Szefler, Stanley J; Larsen, Gary; Spahn, Joseph D; Zeiger, Robert S; Heldt, Gregory; Strunk, Robert C; Bacharier, Leonard B; Bloomberg, Gordon R; Chinchilli, Vernon M; Boehmer, Susan J; Mauger, Elizabeth A; Mauger, David T; Taussig, Lynn M; Martinez, Fernando D

    2004-06-01

    Pediatric asthma remains an important public health concern as its prevalence and cost to the health care system is rising. In order to promote innovative research in asthma therapies, the National Heart, Lung and Blood Institute created the Childhood Asthma Research and Education Network in 1999. As its first study, the steering committee of the Childhood Asthma Research and Education Network designed a randomized clinical trial to determine if persistent asthma could be prevented in children at a high risk to develop the disease. This communication presents the design of its first clinical trial, the Prevention of Asthma in Kids (PEAK) trial and the organization of the Childhood Asthma Research and Education Network that developed and implemented this trial. Studies of the natural history of asthma have shown that, in persistent asthma, the initial asthma-like symptoms and loss of lung function occur predominately during the first years of life. Therefore, in the Prevention of Asthma in Kids study, children 2 and 3 years old with a positive asthma predictive index were randomized to twice daily treatment with fluticasone 88 microg or placebo via metered-dose inhaler and Aerochamber for 2 years. The double blind treatment period was followed by a 1-year observational period. Lung function was measured by spirometry and oscillometry technique at 4-month intervals throughout the study. Bronchodilator reversibility and exhaled nitric oxide (ENO) studies were performed at the end of the treatment and observation periods. The primary outcome measure was the number of asthma-free days. Other secondary outcomes included number of exacerbations, use of asthma medications and lung function. These measures were chosen to reflect the progression of the disease from intermittent wheezing to persistent asthma and measurement of the extent of airflow limitation and airway reactivity.

  13. Rationale and design of a long term follow-up study of women who did and did not receive HPV 16/18 vaccination in Guanacaste, Costa Rica.

    Science.gov (United States)

    Gonzalez, Paula; Hildesheim, Allan; Herrero, Rolando; Katki, Hormuzd; Wacholder, Sholom; Porras, Carolina; Safaeian, Mahboobeh; Jimenez, Silvia; Darragh, Teresa M; Cortes, Bernal; Befano, Brian; Schiffman, Mark; Carvajal, Loreto; Palefsky, Joel; Schiller, John; Ocampo, Rebeca; Schussler, John; Lowy, Douglas; Guillen, Diego; Stoler, Mark H; Quint, Wim; Morales, Jorge; Avila, Carlos; Rodriguez, Ana Cecilia; Kreimer, Aimée R

    2015-04-27

    The Costa Rica Vaccine Trial (CVT) was a randomized clinical trial conducted between 2004 and 2010, which randomized 7466 women aged 18 to 25 to receive the bivalent HPV-16/18 vaccine or control Hepatitis-A vaccine. Participants were followed for 4 years with cross-over vaccination at the study end. In 2010 the long term follow-up (LTFU) study was initiated to evaluate the 10-year impact of HPV-16/18 vaccination, determinants of the immune response, and HPV natural history in a vaccinated population. Herein, the rationale, design and methods of the LTFU study are described, which actively follows CVT participants in the HPV-arm 6 additional years at biennial intervals (3 additional study visits for 10 years of total follow-up), or more often if clinically indicated. According to the initial commitment, women in the Hepatitis-A arm were offered HPV vaccination at cross-over; they were followed 2 additional years and exited from the study. 92% of eligible CVT women accepted participation in LTFU. To provide underlying rates of HPV acquisition and cervical disease among unvaccinated women to compare with the HPV-arm during LTFU, a new unvaccinated control group (UCG) of women who are beyond the age generally recommended for routine vaccination was enrolled, and will be followed by cervical cancer screening over 6 years. To form the UCG, 5000 women were selected from a local census, of whom 2836 women (61% of eligible women) agreed to participate. Over 90% of participants complied with an interview, blood and cervical specimen collection. Evaluation of comparability between the original (Hepatitis-A arm of CVT) and new (UCG) control groups showed that women's characteristics, as well as their predicted future risk for cervical HPV acquisition, were similar, thus validating use of the UCG. LTFU is poised to comprehensively address many important questions related to long-term effects of prophylactic HPV vaccines.

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

    DEFF Research Database (Denmark)

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

    2011-01-01

    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...... 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...... of regular exercise (RE) of the individual patients' own preference based on clinical practice at the local centre. The primary endpoint is reverse remodelling, defined as change in left ventricular end-diastolic diameter assessed by echocardiography. Secondary endpoints include peak oxygen uptake (VO(2peak...

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

    Directory of Open Access Journals (Sweden)

    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

  16. HEALTHY study rationale, design and methods: moderating risk of type 2 diabetes in multi-ethnic middle school students.

    Science.gov (United States)

    Hirst, Kathryn; Baranowski, Tom; DeBar, Lynn; Foster, Gary D; Kaufman, Francine; Kennel, Phyllis; Linder, Barbara; Schneider, Margaret; Venditti, Elizabeth M; Yin, Zenong

    2009-08-01

    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 glycemic dysregulation: body mass index > or =85th percentile, fasting glucose > or =5.55 mmol l(-1) (100 mg per 100 ml) and fasting insulin > or =180 pmol l(-1) (30 microU ml(-1)). A series of pilot studies established the feasibility of performing data collection procedures and tested the development of an intervention consisting of four integrated components: (1) changes in the quantity and nutritional quality of food and beverage offerings throughout the total school food environment; (2) physical education class lesson plans and accompanying equipment to increase both participation and number of minutes spent in moderate-to-vigorous physical activity; (3) brief classroom activities and family outreach vehicles to increase knowledge, enhance decision-making skills and support and reinforce youth in accomplishing goals; and (4) communications and social marketing strategies to enhance and promote changes through messages, images, events and activities. Expert study staff provided training, assistance, materials and guidance for school faculty and staff to implement the intervention components. A cohort of students were enrolled in sixth grade and followed to end of eighth grade. They attended a health screening data collection at baseline and end of study that involved measurement of height, weight, blood pressure, waist circumference and a fasting blood draw. Height and weight were also collected at the end of the seventh grade. The study was conducted in 42 middle schools, six at each of seven locations across the country, with 21 schools randomized to receive the intervention and 21 to act as controls (data collection activities only). Middle school was the unit of

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

    Directory of Open Access Journals (Sweden)

    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

  18. Upper limb international spasticity study: rationale and protocol for a large, international, multicentre prospective cohort study investigating management and goal attainment following treatment with botulinum toxin A in real-life clinical practice

    OpenAIRE

    Turner-Stokes, Lynne; Fheodoroff, Klemens; Jacinto, Jorge; Maisonobe, Pascal; Zakine, Benjamin

    2013-01-01

    Objectives This article provides an overview of the Upper Limb International Spasticity (ULIS) programme, which aims to develop a common core dataset for evaluation of real-life practice and outcomes in the treatment of upper-limb spasticity with botulinum toxin A (BoNT-A). Here we present the study protocol for ULIS-II, a large, international cohort study, to describe the rationale and steps to ensure the validity of goal attainment scaling (GAS) as the primary outcome measure. Methods and a...

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

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    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.

  20. Late outcomes after acute pulmonary embolism: rationale and design of FOCUS, a prospective observational multicenter cohort study.

    Science.gov (United States)

    Konstantinides, Stavros V; Barco, Stefano; Rosenkranz, Stephan; Lankeit, Mareike; Held, Matthias; Gerhardt, Felix; Bruch, Leonard; Ewert, Ralf; Faehling, Martin; Freise, Julia; Ghofrani, Hossein-Ardeschir; Grünig, Ekkehard; Halank, Michael; Heydenreich, Nadine; Hoeper, Marius M; Leuchte, Hanno H; Mayer, Eckhard; Meyer, F Joachim; Neurohr, Claus; Opitz, Christian; Pinto, Antonio; Seyfarth, Hans-Jürgen; Wachter, Rolf; Zäpf, Bianca; Wilkens, Heinrike; Binder, Harald; Wild, Philipp S

    2016-11-01

    Acute pulmonary embolism (PE) is a frequent cause of death and serious disability. The risk of PE-associated mortality and morbidity extends far beyond the acute phase of the disease. In earlier follow-up studies, as many as 30 % of the patients died during a follow-up period of up to 3 years, and up to 50 % of patients continued to complain of dyspnea and/or poor physical performance 6 months to 3 years after the index event. The most feared 'late sequela' of PE is chronic thromboembolic pulmonary hypertension (CTEPH), the true incidence of which remains obscure due to the large margin of error in the rates reported by mostly small, single-center studies. Moreover, the functional and hemodynamic changes corresponding to early, possibly reversible stages of CTEPH, have not been systematically investigated. The ongoing Follow-Up after acute pulmonary embolism (FOCUS) study will prospectively enroll and systematically follow, over a 2-year period and with a standardized comprehensive program of clinical, echocardiographic, functional and laboratory testing, a large multicenter prospective cohort of 1000 unselected patients (all-comers) with acute symptomatic PE. FOCUS will possess adequate power to provide answers to relevant remaining questions regarding the patients' long-term morbidity and mortality, and the temporal pattern of post-PE abnormalities. It will hopefully provide evidence for future guideline recommendations regarding the selection of patients for long-term follow-up after PE, the modalities which this follow-up should include, and the findings that should be interpreted as indicating progressive functional and hemodynamic post-PE impairment, or the development of CTEPH.

  1. Evaluation of primary care midwifery in the Netherlands: design and rationale of a dynamic cohort study (DELIVER

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    Manniën Judith

    2012-03-01

    Full Text Available Abstract Background In the Netherlands, midwives are autonomous medical practitioners and 78% of pregnant women start their maternity care with a primary care midwife. Scientific research to support evidence-based practice in primary care midwifery in the Netherlands has been sparse. This paper describes the research design and methodology of the multicenter multidisciplinary prospective DELIVER study which is the first large-scale study evaluating the quality and provision of primary midwifery care. Methods/Design Between September 2009 and April 2011, data were collected from clients and their partners, midwives and other healthcare professionals across the Netherlands. Clients from twenty midwifery practices received up to three questionnaires to assess the expectations and experiences of clients (e.g. quality of care, prenatal screening, emotions, health, and lifestyle. These client data were linked to data from the Netherlands Perinatal Register and electronic client records kept by midwives. Midwives and practice assistants from the twenty participating practices recorded work-related activities in a diary for one week, to assess workload. Besides, the midwives were asked to complete a questionnaire, to gain insight into collaboration of midwives with other care providers, their tasks and attitude towards their job, and the quality of the care they provide. Another questionnaire was sent to all Dutch midwifery practices which reveals information regarding the organisation of midwifery practices, provision of preconception care, collaboration with other care providers, and provision of care to ethnic minorities. Data at client, midwife and practice level can be linked. Additionally, partners of pregnant women and other care providers were asked about their expectations and experiences regarding the care delivered by midwives and in six practices client consults were videotaped to objectively assess daily practice. Discussion In total, 7685

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

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    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

  3. Rationale for assessing safety and efficacy of drug candidates alone and in combination with medical devices: The case study of SpinalonTM.

    Science.gov (United States)

    Guertin, Pierre A

    2016-12-07

    The aim of this review is to describe the rationale and main underlying reasons for undertaking, during clinical development, the study of drug candidates used separately and/or in combination with other technologies. To ease comprehension, reference will be made to the case of SpinalonTM, a new fixed-dose combination (FDC) product composed of levodopa/carbidopa/buspirone. This drug is capable of triggering, within minutes after a single administration orally, 45 minute- episodes of basic involuntary 'reflex' walking in paraplegic animals. Daily administration during one month was shown to lead to increased performance over time, with health benefits onto musculoskeletal and cardiovascular systems. A double-blind, dose-escalation, randomized phase I/IIa study with 45 spinal cord-injured subjects successfully provided the maximal tolerated dose (MTD) and preliminary evidence of efficacy. As an attempt to explore how efficacy may be optimized, a phase IIb study with 150 subjects was designed to compare the effects of repeated administration in different conditions (arms). Tests with a motorized treadmill, a harness for body weight support, a transdermal spinal cord stimulator and/or an exoskeleton were proposed because: 1) these devices are unlikely to alter safety but, 2) they are reasonably expected to increase spinal locomotor neuron activation, reflex walking induction, and musculoskeletal/cardiovascular benefits. This approach would normally allow the phase III study to demonstrate clearly, with fewer subjects and at lower costs, long-term benefits on health of SpinalonTM used in optimized conditions and settings. This innovative strategy in drug development may contribute to further describe the mechanisms of action as well as optimized conditions of use for patients. Adapted to the development of other products, such an approach may enable greater safety, efficacy, clinical utility and compliance to be sought for next-generation CNS drugs.

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

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    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

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

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    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

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

    Science.gov (United States)

    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.

  7. Study exploring depression and cardiovascular diseases amongst Arabic speaking patients living in the State of Qatar: Rationale and methodology.

    Science.gov (United States)

    Donnelly, Tam Truong; Al Suwaidi, Jassim M; Alqahtani, Awad; Assad, Nidal; Qader, Najla Abdul; Byrne, Carolyn; Singh, Rajvir; Fung, Tak Shing

    2012-01-01

    In Qatar, cardiovascular diseases are the leading cause of death. Studies show that depression is associated with an increased morbidity and mortality among cardiovascular patients. Thus, early detection of, and intervention for, depression among cardiovascular patients can reduce cardiovascular morbidity and mortality, and save health care costs. To date there is no study in the Gulf region exploring depression among cardiovascular patients. The goals of our three-phase research program are to (1) understand the mental health issues, specifically depression, as experienced by cardiovascular patients living in the State of Qatar; (2) identify and implement strategies that would prevent depression and assist patients to deal with depression; and (3) evaluate, facilitate, and sustain strategies that are effective at reducing depression and foster its treatment among cardiovascular patients. This paper describe phase I of the research program. Using both quantitative and qualitative research methodologies, we will investigate (1) the prevalence and severity of depression among patients who have confirmed diagnosis of cardiovascular diseases (2) how contextual factors such as social, cultural, and economic factors contribute to the risk of depression and its management among cardiovascular patients, and (3) formulate effective intervention strategies that are expected to increase awareness, prevention of and treatment for depression among cardiovascular patients, thus reducing cardiovascular diseases morbidity and mortality in Qatar.

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

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    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.

  9. The Moli-Sani Project, a randomized, prospective cohort study in the Molise region in Italy; design, rationale and objectives

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    Licia Iacoviello

    2007-06-01

    Full Text Available

    Background: Cardiovascular disease and malignancies account for more than 70% of all causes of mortality and morbidity in Italy. There is a subtle balance between genetic determinants and lifestyle, that often defines the line between health and sickness. So far studies aiming at identifying risk factors have mainly come from Northern Europe and the USA. It was to understand this balance between genetics and environmental determinants better, and to tailor appropriate preventive strategies for Italian and other Southern European populations, that theMoli-sani project was launched, transforming a small Italian region into a large scientific laboratory: the “Molise lab”.

    Methods: Each participant receives a thorough medical check-up at no cost to either him/her or the national health service, resulting in thousands of hours of free public health care. With a completely computerized system, Moli-sani is a “paperless” study, in which researchers and participants communicate using recently developed technologies such as mobile phone text messages (SMS. The newly established biological data bank (the “MoliBank” will be one of the largest in Europe. Results: Early results of 8000 participants so far show a slightly worrying pattern of risk factors for a Mediterranean population. The prevalence of obesity, hypertension and metabolic syndrome is growing at rates close to those of other Western countries. Hypertension and, to a lesser extent, high blood glucose levels, are under-diagnosed and underestimated by patients, and appropriate therapy appears under-used and not very successful. However, cholesterol management appears more efficient.

    Conclusions: Paying particular attention towards innovation and new technologies, theMoli-sani project has placed itself at the cutting edge of a new paradigm crossing research and prevention.

  10. Methods and rationale used in a matched cohort study of the incidence of new primary cancers following prostate cancer

    Directory of Open Access Journals (Sweden)

    Cronin-Fenton DP

    2013-10-01

    Full Text Available Deirdre P Cronin-Fenton,1 Sussie Antonsen,1 Karynsa Cetin,2 John Acquavella,2 Andre Daniels,3 Timothy L Lash1,4 1Department of Clinical Epidemiology, Aarhus University Hospital, Aarhus, Denmark; 2Center for Observational Research, Amgen Incorporated, Thousand Oaks, CA, USA; 3Global Regulatory Affairs and Safety, Amgen Incorporated, Thousand Oaks, CA, USA; 4Department of Epidemiology, Rollins School of Public Health, Emory University, Atlanta, GA, USA Objectives: We describe several methodological issues that were addressed in conducting a Danish population-based matched cohort study comparing rates of new primary cancers (NPCs in men with and without prostate cancer (PC. Methods: We matched 30,220 men with PC to 151,100 men without PC (comparators on age (±2 years and PC diagnosis/index date. We focused on several methodological issues: 1 to address survival differences between the cohorts we compared rates with and without censoring comparators on the date their matched PC patient died or was censored; 2 to address diagnostic bias, we excluded men with a history of cancer from the comparator cohort; 3 to address prostate cancer immunity, we graphed the hazard of NPC in both cohorts, with and without prostate cancer as an outcome; 4 we used empirical Bayes methods to explore the effect of adjusting for multiple comparisons. Results: After 18 months of follow-up, cumulative person-time was lower in the PC than comparator cohort due to higher mortality among PC patients. Terminating person-time in comparators at the matched PC patient's death or loss to follow-up resulted in comparable person-time up to 30 months of follow-up and lower person-time among comparators thereafter. The hazard of NPC was lower among men with PC than comparators throughout follow-up. There was little difference in rates beyond the first four years of follow-up after removing PC as an outcome. Empirical Bayes adjustment for multiple comparisons had little effect on the

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

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    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

  12. 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

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    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

  13. The Genetic Response to Short-term Interventions Affecting Cardiovascular Function: Rationale and Design of the HAPI Heart Study

    Science.gov (United States)

    Mitchell, Braxton D.; McArdle, Patrick F.; Shen, Haiqing; Rampersaud, Evadnie; Pollin, Toni I.; Bielak, Lawrence F.; Jaquish, Cashell; Douglas, Julie A.; Roy-Gagnon, Marie-Hélène; Sack, Paul; Naglieri, Rosalie; Hines, Scott; Horenstein, Richard B.; Chang, Yen-Pei C.; Post, Wendy; Ryan, Kathleen A.; Brereton, Nga Hong; Pakyz, Ruth E.; Sorkin, John; Damcott, Coleen M.; O’Connell, Jeffrey R.; Mangano, Charles; Corretti, Mary; Vogel, Robert; Herzog, William; Weir, Matthew R.; Peyser, Patricia A.; Shuldiner, Alan R.

    2008-01-01

    Background The etiology of cardiovascular disease (CVD) is multifactorial. Efforts to identify genes influencing CVD risk have met with limited success to date, likely due to the small effect sizes of common CVD risk alleles and the presence of gene by gene and gene by environment interactions. Methods The Heredity and Phenotype Intervention (HAPI) Heart Study was initiated in 2002 to measure the cardiovascular response to four short-term interventions affecting cardiovascular risk factors and to identify the genetic and environmental determinants of these responses. The measurements included blood pressure responses to the cold pressor stress test and to a high salt diet, triglyceride excursion in response to a high fat challenge, and response in platelet aggregation to aspirin therapy. Results The interventions were carried out in 868 relatively healthy Amish adults from large families. The heritabilities of selected response traits for each intervention ranged from 8–38%, suggesting that some of the variation associated with response to each intervention can be attributed to the additive effects of genes. Conclusions Identifying these response genes may identify new mechanisms influencing CVD and may lead to individualized preventive strategies and improved early detection of high-risk individuals. PMID:18440328

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

    Energy Technology Data Exchange (ETDEWEB)

    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.

  15. Personalized Risk Estimator for Rheumatoid Arthritis (PRE-RA) Family Study: Rationale and design for a randomized controlled trial evaluating rheumatoid arthritis risk education to first-degree relatives

    OpenAIRE

    Sparks, Jeffrey A.; Iversen, Maura D.; Kroouze, Rachel Miller; Mahmoud, Taysir G.; Triedman, Nellie A.; Kalia, Sarah S.; Atkinson, Michael L.; Lu, Bing; Deane, Kevin D.; Costenbader, Karen H.; Green, Robert C.; Elizabeth W. Karlson

    2014-01-01

    We present the rationale, design features, and protocol of the Personalized Risk Estimator for Rheumatoid Arthritis (PRE-RA) Family Study (ClinicalTrials.gov NCT02046005). The PRE-RA Family Study is an NIH-funded prospective, randomized controlled trial designed to compare the willingness to change behaviors in first-degree relatives of rheumatoid arthritis (RA) patients without RA after exposure to RA risk educational programs. Consented subjects are randomized to receive education concernin...

  16. Rationale and study protocol for a multi-component Health Information Technology (HIT) screening tool for depression and post-traumatic stress disorder in the primary care setting.

    Science.gov (United States)

    Biegler, Kelly; Mollica, Richard; Sim, Susan Elliott; Nicholas, Elisa; Chandler, Maria; Ngo-Metzger, Quyen; Paigne, Kittya; Paigne, Sompia; Nguyen, Danh V; Sorkin, Dara H

    2016-09-01

    The prevalence rate of depression in primary care is high. Primary care providers serve as the initial point of contact for the majority of patients with depression, yet, approximately 50% of cases remain unrecognized. The under-diagnosis of depression may be further exacerbated in limited English-language proficient (LEP) populations. Language barriers may result in less discussion of patients' mental health needs and fewer referrals to mental health services, particularly given competing priorities of other medical conditions and providers' time pressures. Recent advances in Health Information Technology (HIT) may facilitate novel ways to screen for depression and other mental health disorders in LEP populations. The purpose of this paper is to describe the rationale and protocol of a clustered randomized controlled trial that will test the effectiveness of an HIT intervention that provides a multi-component approach to delivering culturally competent, mental health care in the primary care setting. The HIT intervention has four components: 1) web-based provider training, 2) multimedia electronic screening of depression and PTSD in the patients' primary language, 3) Computer generated risk assessment scores delivered directly to the provider, and 4) clinical decision support. The outcomes of the study include assessing the potential of the HIT intervention to improve screening rates, clinical detection, provider initiation of treatment, and patient outcomes for depression and post-traumatic stress disorder (PTSD) among LEP Cambodian refugees who experienced war atrocities and trauma during the Khmer Rouge. This technology has the potential to be adapted to any LEP population in order to facilitate mental health screening and treatment in the primary care setting.

  17. Humanities Program: Critique and Rationale.

    Science.gov (United States)

    Pinar, William Frederick

    The psychological impact of schooling is examined within the context of a new school of British psychoanalytic thought. It is concluded that schooling is maddening, in the sense used by Laing, Cooper, and others. A rationale for a sane humanities program is established consisting of two components: the nuclear and the cortical. The nuclear is the…

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

    Directory of Open Access Journals (Sweden)

    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

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

    Directory of Open Access Journals (Sweden)

    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

  20. 33 CFR 279.9 - Objective rationale.

    Science.gov (United States)

    2010-07-01

    ... 33 Navigation and Navigable Waters 3 2010-07-01 2010-07-01 false Objective rationale. 279.9... DEFENSE RESOURCE USE: ESTABLISHMENT OF OBJECTIVES § 279.9 Objective rationale. (a) Statement of objectives... objective(s) and providing the rationale, impact, and basic management measures for their...

  1. Space Resource Roundtable Rationale

    Science.gov (United States)

    Duke, Michael

    1999-01-01

    Recent progress in the U.S. Space Program has renewed interest in space resource issues. The Lunar Prospector mission conducted in NASA's Discovery Program has yielded interesting new insights into lunar resource issues, particularly the possibility that water is concentrated in cold traps at the lunar poles. This finding has not yet triggered a new program of lunar exploration or development, however it opens the possibility that new Discovery Missions might be viable. Several asteroid missions are underway or under development and a mission to return samples from the Mars satellite, Phobos, is being developed. These exploration missions are oriented toward scientific analysis, not resource development and utilization, but can provide additional insight into the possibilities for mining asteroids. The Mars Surveyor program now includes experiments on the 2001 lander that are directly applicable to developing propellants from the atmosphere of Mars, and the program has solicited proposals for the 2003/2005 missions in the area of resource utilization. These are aimed at the eventual human exploration of Mars. The beginning of construction of the International Space Station has awakened interest in follow-on programs of human exploration, and NASA is once more studying the human exploration of Moon, Mars and asteroids. Resource utilization will be included as objectives by some of these human exploration programs. At the same time, research and technology development programs in NASA such as the Microgravity Materials Science Program and the Cross-Enterprise Technology Development Program are including resource utilization as a valid area for study. Several major development areas that could utilize space resources, such as space tourism and solar power satellite programs, are actively under study. NASA's interests in space resource development largely are associated with NASA missions rather than the economic development of resources for industrial processes. That

  2. Personalized Risk Estimator for Rheumatoid Arthritis (PRE-RA) Family Study: rationale and design for a randomized controlled trial evaluating rheumatoid arthritis risk education to first-degree relatives.

    Science.gov (United States)

    Sparks, Jeffrey A; Iversen, Maura D; Miller Kroouze, Rachel; Mahmoud, Taysir G; Triedman, Nellie A; Kalia, Sarah S; Atkinson, Michael L; Lu, Bing; Deane, Kevin D; Costenbader, Karen H; Green, Robert C; Karlson, Elizabeth W

    2014-09-01

    We present the rationale, design features, and protocol of the Personalized Risk Estimator for Rheumatoid Arthritis (PRE-RA) Family Study (ClinicalTrials.gov NCT02046005). The PRE-RA Family Study is an NIH-funded prospective, randomized controlled trial designed to compare the willingness to change behaviors in first-degree relatives of rheumatoid arthritis (RA) patients without RA after exposure to RA risk educational programs. Consented subjects are randomized to receive education concerning their personalized RA risk based on demographics, RA-associated behaviors, genetics, and biomarkers or to receive standard RA information. Four behavioral factors associated with RA risk were identified from prior studies for inclusion in the risk estimate: cigarette smoking, excess body weight, poor oral health, and low fish intake. Personalized RA risk information is presented through an online tool that collects data on an individual's specific age, gender, family history, and risk-related behaviors; presents genetic and biomarker results; displays relative and absolute risk of RA; and provides personalized feedback and education. The trial outcomes will be changes in willingness to alter behaviors from baseline to 6 weeks, 6 months, and 12 months in the three intervention groups. The design and the execution of this trial that targets a special population at risk for RA, while incorporating varied risk factors into a single risk tool, offer distinct challenges. We provide the theoretical rationale for the PRE-RA Family Study and highlight particular design features of this trial that utilize personalized risk education as an intervention.

  3. Rationale, Design and Methods of the Ecological Study of Sexual Behaviors and HIV/STI among African American Men Who Have Sex with Men in the Southeastern United States (The MARI Study.

    Directory of Open Access Journals (Sweden)

    DeMarc A Hickson

    Full Text Available This paper describes the rationale, design, and methodology of the Ecological Study of Sexual Behaviors and HIV/STI among African American Men Who Have Sex with Men (MSM in the Southeastern United States (U.S.; known locally simply as the MARI Study.Participants are African American MSM aged 18 years and older residing in the deep South.Between 2013 and 2015, 800 African American MSM recruited from two study sites (Jackson, MS and Atlanta, GA will undergo a 1.5-hour examination to obtain anthropometric and blood pressure measures as well as to undergo testing for sexually transmitted infections (STI, including HIV. Intrapersonal, interpersonal, and environmental factors are assessed by audio computer-assisted self-interview survey. Primary outcomes include sexual risk behaviors (e.g., condomless anal sex and prevalent STIs (HIV, syphilis, gonorrhea, and Chlamydia.The MARI Study will typify the HIV environmental 'riskscape' and provide empirical evidence into novel ecological correlates of HIV risk among African American MSM in the deep South, a population most heavily impacted by HIV. The study's anticipated findings will be of interest to a broad audience and lead to more informed prevention efforts, including effective policies and interventions, that achieve the goals of the updated 2020 U.S. National HIV/AIDS Strategy.

  4. Rationales behind the choice of administration form with fentanyl

    DEFF Research Database (Denmark)

    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...... in two rating rounds, respectively. The most important reason to choose fentanyl patches was that patients' clinical condition did not allow them to take analgesia orally. OTFCs were primarily seen as a self-administrative alternative to injections in case of breakthrough pain. The main reasons...... for not choosing OTFCs were intolerance to fentanyl and price. The most important possible rationale to choose fentanyl nasal spray was easy administration. The most important possible reasons to not choose fenanyl nasal spray were application side effects. CONCLUSIONS: The rationale behind the choice...

  5. [The medical rationale category and a new epistemology in health].

    Science.gov (United States)

    do Nascimento, Marilene Cabral; de Barros, Nelson Filice; Nogueira, Maria Inês; Luz, Madel Therezinha

    2013-12-01

    This article is an analytical report on the 20-year trajectory of the 'medical rationale' category that emerged in the early 1990s in the area of Social and Human Sciences in Health in the field of Public Health. Its objective was to study complex and therapeutic medical systems and traditional, complementary and alternative medicines. Based on a critical review of the literature, it presents some aspects of the cultural, political, institutional and social context of its emergence, as well as its main contributions and developments on a theoretical level and on social policies and practices in health. The southern epistemology concept of Boaventura de Sousa Santos is used to reflect upon the contribution of the 'medical rationale' category to the critique of the post-modern scientific rationale and to the creation of a new epistemology in health.

  6. When Regional Innovation Policies Meet Policy Rationales and Evidence

    DEFF Research Database (Denmark)

    Borrás, Susana; Jordana, Jacint

    2016-01-01

    In spite of recent advancements regarding regional innovation policy rationales and evidence, there are few analyses about the actual features of existing regional innovation policies. Nevertheless, a policy analysis perspective is important in order to recognize their distinctive patterns across...... regions, and to understand how rationales and evidence can be translated into policy-making. To this purpose, this paper develops a framework to study the extent to which regional innovation policies have changed during the past few years. Since the mid-2000s, there has been an important development...

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

    Directory of Open Access Journals (Sweden)

    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

  8. 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

    Directory of Open Access Journals (Sweden)

    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.

  9. Working Inside for Smoking Elimination (Project W.I.S.E. study design and rationale to prevent return to smoking after release from a smoke free prison

    Directory of Open Access Journals (Sweden)

    Mello Jennifer

    2011-10-01

    Full Text Available Abstract Background Incarcerated individuals suffer disproportionately from the health effects of tobacco smoking due to the high smoking prevalence in this population. In addition there is an over-representation of ethnic and racial minorities, impoverished individuals, and those with mental health and drug addictions in prisons. Increasingly, prisons across the U.S. are becoming smoke free. However, relapse to smoking is common upon release from prison, approaching 90% within a few weeks. No evidence based treatments currently exist to assist individuals to remain abstinent after a period of prolonged, forced abstinence. Methods/Design This paper describes the design and rationale of a randomized clinical trial to enhance smoking abstinence rates among individuals following release from a tobacco free prison. The intervention is six weekly sessions of motivational interviewing and cognitive behavioral therapy initiated approximately six weeks prior to release from prison. The control group views six time matched videos weekly starting about six weeks prior to release. Assessments take place in-person 3 weeks after release and then for non-smokers every 3 months up to 12 months. Smoking status is confirmed by urine cotinine. Discussion Effective interventions are greatly needed to assist these individuals to remain smoke free and reduce health disparities among this socially and economically challenged group. Trial Registration NCT01122589

  10. The effects of nocturnal hemodialysis compared to conventional hemodialysis on change in left ventricular mass: Rationale and study design of a randomized controlled pilot study

    Directory of Open Access Journals (Sweden)

    Klarenbach Scott

    2006-02-01

    Full Text Available Abstract Background Nocturnal hemodialysis (NHD is an alternative to conventional three times per week hemodialysis (CvHD and has been reported to improve several health outcomes. To date, no randomized controlled trial (RCT has compared NHD and CvHD. We have undertaken a multi-center RCT in hemodialysis patients comparing the effect of NHD to CvHD on left ventricular (LV mass, as measured by cardiac magnetic resonance imaging (cMR. Methodology/design All patients in Alberta, Canada, expressing an interest in performing NHD are eligible for the study. Patients enrolled in the study will be randomized to either NHD or CvHD for a six month period. All patients will have a full clinical assessment, including collection of biochemical and cMR data at baseline and at 6 months. Both groups of patients will be monitored biweekly to optimize blood pressure (BP to a goal of Discussion To our knowledge, this study will be the first RCT evaluating health outcomes in NHD. The impact of NHD on LV mass represents a clinically important outcome which will further elucidate the potential benefits of NHD and guide future clinical endpoint studies.

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

    Science.gov (United States)

    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…

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

    Directory of Open Access Journals (Sweden)

    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

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

    Science.gov (United States)

    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,…

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

    Directory of Open Access Journals (Sweden)

    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

  15. A Phase III Study of Durvalumab (MEDI4736) With or Without Tremelimumab for Previously Treated Patients With Advanced NSCLC: Rationale and Protocol Design of the ARCTIC Study.

    Science.gov (United States)

    Planchard, David; Yokoi, Takashi; McCleod, Michael J; Fischer, Jürgen R; Kim, Young-Chul; Ballas, Marc; Shi, Kelvin; Soria, Jean-Charles

    2016-05-01

    Anti-programmed cell death-1 and anti-programmed cell death ligand-1 (PD-L1) monotherapies have shown promising clinical activity in advanced, refractory non-small-cell lung cancer (NSCLC), but antitumor activity appears to be greater in patients with PD-L1(+) tumors compared with patients harboring PD-L1(-) tumors. Combining the anti-PD-L1 antibody durvalumab and the anti-cytotoxic T-lymphocyte antigen 4 antibody tremelimumab offers the potential for antitumor activity in patients with advanced NSCLC, regardless of PD-L1 tumor status. ARCTIC (NCT02352948) is a global, phase III, randomized, open-label multicenter study in patients with advanced NSCLC assessing the safety and clinical activity of durvalumab versus standard of care (SoC; erlotinib, gemcitabine, or vinorelbine) in patients with PD-L1(+) tumors (≥25% of tumor cells with membrane staining using VENTANA PD-L1 [SP263] CDx Assay) (Sub-study A) and the combination of durvalumab + tremelimumab or either agent as monotherapy versus SoC in patients with PD-L1(-) tumors (Sub-study B). Eligible patients are those with locally advanced or metastatic NSCLC (Stage IIIB/IV), without epidermal growth factor receptor tyrosine kinase activating mutations or anaplastic lymphoma kinase rearrangements, who have received at least 2 prior systemic regimens, including 1 platinum-based chemotherapy regimen. Co-primary endpoints are progression-free survival and overall survival. Secondary endpoints include the proportion of patients alive at 12 months, objective response rate, duration of response, progression-free survival at 6 and 12 months, safety and tolerability, pharmacokinetics, immunogenicity, and quality of life. The exploratory endpoints will assess potential biomarkers of treatment response. Recruitment started in January 2015 and is ongoing.

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

    Science.gov (United States)

    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.

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

    Directory of Open Access Journals (Sweden)

    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.

  18. Acute uncomplicated appendicitis study: rationale and protocol for a multicentre, prospective randomised controlled non-inferiority study to evaluate the safety and effectiveness of non-operative management in children with acute uncomplicated appendicitis

    Science.gov (United States)

    Xu, Jane; Liu, Yingrui Cyril; Adams, Susan; Karpelowsky, Jonathan

    2016-01-01

    Introduction This article presents an overview of a prospective randomised controlled non-inferiority study designed to evaluate the safety and effectiveness of non-operative management (NOM) with operative management in children with acute uncomplicated appendicitis (AUA). Here, we present the study protocol for this APRES study, a multicentre Australian study. The rationale and details of future analysis, in particular, non-inferiority calculations, cost-effectiveness, feasibility and acceptability of each intervention. Design A multicentre, prospective randomised controlled clinical trial, conducted in 2 Australian tertiary paediatric hospitals. Participants Children who meet the inclusion criteria of an age between 5 and 15 years and a clinical diagnosis of AUA will be invited to participate, and after consent will be randomised via a computer-based program into treatment groups. The study started in June 2016, and the target recruitment is 220 patients. Interventions Children in the control group will be treated with prophylactic antibiotics and appendicectomy, and those in the intervention group will be treated with antibiotic therapy alone. Primary outcome measures include unplanned or unnecessary operation and complications at 30 days. Secondary outcomes include longer term complications within 1 year, length of stay, time off work and school analgesic requirements and cost. Analysis Data analyses will be on the intention-to-treat principle using non-inferiority analysis. Analysis will include the Pearson χ2 test for categorical variables and independent sample t-test or Mann-Whitney test for continuous variables. Non-inferiority for NOM will be tested using 1-sided Wald tests with an α level of 0.05. Ethics and dissemination The research has been approved by the Human Research Ethics Committee of the Sydney Children's Hospital Network. In addition, results will be reported through academic journals, seminars and conference presentations. Trial

  19. Design and rationale of the GAUSS-2 study trial: a double-blind, ezetimibe-controlled phase 3 study of the efficacy and tolerability of evolocumab (AMG 145) in subjects with hypercholesterolemia who are intolerant of statin therapy.

    Science.gov (United States)

    Cho, Leslie; Rocco, Michael; Colquhoun, David; Sullivan, David; Rosenson, Robert S; Dent, Ricardo; Xue, Allen; Scott, Rob; Wasserman, Scott M; Stroes, Erik

    2014-03-01

    Statins effectively lower low-density lipoprotein cholesterol (LDL-C), reducing cardiovascular morbidity and mortality. Most patients tolerate statins well, but approximately 10% to 20% experience side effects (primarily muscle-related) contributing to diminished compliance or discontinuation of statin therapy and subsequent increase in cardiovascular risk. Statin-intolerant patients require more effective therapies for lowering LDL-C. Proprotein convertase subtilisin/kexin type 9 (PCSK9) is a compelling target for LDL-C-lowering therapy. Evolocumab (AMG 145) is a fully human monoclonal antibody that binds PCSK9, inhibiting its interaction with the LDL receptor to preserve LDL-receptor recycling and reduce LDL-C. Phase 2 studies have demonstrated the safety, tolerability, and preliminary efficacy of subcutaneous evolocumab in diverse populations, including statin-intolerant patients. This article describes the rationale and design of the Goal Achievement After Utilizing an anti-PCSK9 Antibody in Statin-Intolerant Subjects 2 (GAUSS-2) trial, a randomized, double-blind, ezetimibe-controlled, multicenter phase 3 study to evaluate the effects of 12 weeks of evolocumab 140 mg every 2 weeks or 420 mg every month in statin-intolerant patients with hypercholesterolemia. Eligible subjects were unable to tolerate effective doses of ≥2 statins because of myalgia, myopathy, myositis, or rhabdomyolysis that resolved with statin discontinuation. The primary objective of the study is to assess the effects of evolocumab on percentage change from baseline in LDL-C. Secondary objectives include evaluation of safety and tolerability, comparison of the effects of evolocumab vs ezetimibe on absolute change from baseline in LDL-C, and percentage changes from baseline in other lipids. Recruitment of approximately 300 subjects was completed in August 2013.

  20. The Escitalopram versus Electric Current Therapy for Treating Depression Clinical Study (ELECT-TDCS: rationale and study design of a non-inferiority, triple-arm, placebo-controlled clinical trial

    Directory of Open Access Journals (Sweden)

    André Russowsky Brunoni

    Full Text Available CONTEXT AND OBJECTIVE: Major depressive disorder (MDD is a common psychiatric condition, mostly treated with antidepressant drugs, which are limited due to refractoriness and adverse effects. We describe the study rationale and design of ELECT-TDCS (Escitalopram versus Electric Current Therapy for Treating Depression Clinical Study, which is investigating a non-pharmacological treatment known as transcranial direct current stimulation (tDCS.DESIGN AND SETTING: Phase-III, randomized, non-inferiority, triple-arm, placebo-controlled study, ongoing in São Paulo, Brazil.METHODS: ELECT-TDCS compares the efficacy of active tDCS/placebo pill, sham tDCS/escitalopram 20 mg/day and sham tDCS/placebo pill, for ten weeks, randomizing 240 patients in a 3:3:2 ratio, respectively. Our primary aim is to show that tDCS is not inferior to escitalopram with a non-inferiority margin of at least 50% of the escitalopram effect, in relation to placebo. As secondary aims, we investigate several biomarkers such as genetic polymorphisms, neurotrophin serum markers, motor cortical excitability, heart rate variability and neuroimaging.RESULTS: Proving that tDCS is similarly effective to antidepressants would have a tremendous impact on clinical psychiatry, since tDCS is virtually devoid of adverse effects. Its ease of use, portability and low price are further compelling characteristics for its use in primary and secondary healthcare. Multimodal investigation of biomarkers will also contribute towards understanding the antidepressant mechanisms of action of tDCS.CONCLUSION: Our results have the potential to introduce a novel technique to the therapeutic arsenal of treatments for depression.

  1. Bioethics: A Rationale and a Model

    Science.gov (United States)

    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)

  2. Rationale and methods of the integrated biomarker and imaging study (IBIS): combining invasive and non-invasive imaging with biomarkers to detect subclinical atherosclerosis and assess coronary lesion biology.

    Science.gov (United States)

    Van Mieghem, Carlos A G; Bruining, Nico; Schaar, Johannes A; McFadden, Eugene; Mollet, Nico; Cademartiri, Filippo; Mastik, Frits; Ligthart, Jurgen M R; Granillo, Gaston A Rodriguez; Valgimigli, Marco; Sianos, Georgios; van der Giessen, Willem J; Backx, Bianca; Morel, Marie-Angele M; Van Es, Gerrit-Anne; Sawyer, Jonathon D; Kaplow, June; Zalewski, Andrew; van der Steen, Anton F W; de Feyter, Pim; Serruys, Patrick W

    2005-08-01

    Death or myocardial infarction, the most serious clinical consequences of atherosclerosis, often result from plaque rupture at non-flow limiting lesions. Current diagnostic imaging with coronary angiography only detects large plaques that already impinge on the lumen and cannot accurately identify those that have a propensity to cause unheralded events. Accurate evaluation of the composition or of the biomechanical characteristics of plaques with invasive or non-invasive methods, alone or in conjunction with assessment of circulating biomarkers, could help identify high-risk patients, thus providing the rationale for aggressive treatments in order to reduce future clinical events. The IBIS (Integrated Biomarker and Imaging Study) study is a prospective, single-center, non-randomized, observational study conducted in Rotterdam. The aim of the IBIS study is to evaluate both invasive (quantitative coronary angiography, intravascular ultrasound (IVUS) and palpography) and non-invasive (multislice spiral computed tomography) imaging techniques to characterize non-flow limiting coronary lesions. In addition, multiple classical and novel biomarkers will be measured and their levels correlated with the results of the different imaging techniques. A minimum of 85 patients up to a maximum of 120 patients will be included. This paper describes the study protocol and methodological solutions that have been devised for the purpose of comparisons among several imaging modalities. It outlines the analyses that will be performed to compare invasive and non-invasive imaging techniques in conjunction with multiple biomarkers to characterize non-flow limiting subclinical coronary lesions.

  3. Assessing the 1992 Presidential and Vice Presidential Debates: The Public Rationale.

    Science.gov (United States)

    Winkler, Carol K.; Black, Catherine F.

    1993-01-01

    Reports on the rationales used by viewers in determining winners and conclusions about televised political campaign debates. Studies responses of 370 viewers of the 1992 presidential and vice presidential debates. Analyzes data and determines trends suggested by the results. (HB)

  4. Educational Rationale Metadata for Learning Objects

    Directory of Open Access Journals (Sweden)

    Tom Carey

    2002-10-01

    Full Text Available Instructors searching for learning objects in online repositories will be guided in their choices by the content of the object, the characteristics of the learners addressed, and the learning process embodied in the object. We report here on a feasibility study for metadata to record process-oriented information about instructional approaches for learning objects, though a set of Educational Rationale [ER] tags which would allow authors to describe the critical elements in their design intent. The prototype ER tags describe activities which have been demonstrated to be of value in learning, and authors select the activities whose support was critical in their design decisions. The prototype ER tag set consists descriptors of the instructional approach used in the design, plus optional sub-elements for Comments, Importance and Features which implement the design intent. The tag set was tested by creators of four learning object modules, three intended for post-secondary learners and one for K-12 students and their families. In each case the creators reported that the ER tag set allowed them to express succinctly the key instructional approaches embedded in their designs. These results confirmed the overall feasibility of the ER tag approach as a means of capturing design intent from creators of learning objects. Much work remains to be done before a usable ER tag set could be specified, including evaluating the impact of ER tags during design to improve instructional quality of learning objects.

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

    NARCIS (Netherlands)

    Slikkerveer, J.; Dijkmans, P.A.; Sieswerda, G.T.; Doevendans, P.A.; Dijk, A.P.J. van; Verheugt, F.W.A.; Porter, T.R.; Kamp, O.

    2008-01-01

    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

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

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    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

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

    Directory of Open Access Journals (Sweden)

    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.

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

    Science.gov (United States)

    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.

  9. Rationale and methods of the cardiometabolic valencian study (escarval-risk for validation of risk scales in mediterranean patients with hypertension, diabetes or dyslipidemia

    Directory of Open Access Journals (Sweden)

    Trillo Jose L

    2010-11-01

    Full Text Available Abstract Background The Escarval-Risk study aims to validate cardiovascular risk scales in patients with hypertension, diabetes or dyslipidemia living in the Valencia Community, a European Mediterranean region, based on data from an electronic health recording system comparing predicted events with observed during 5 years follow-up study. Methods/Design A cohort prospective 5 years follow-up study has been designed including 25000 patients with hypertension, diabetes and/or dyslipidemia attended in usual clinical practice. All information is registered in a unique electronic health recording system (ABUCASIS that is the usual way to register clinical practice in the Valencian Health System (primary and secondary care. The system covers about 95% of population (near 5 million people. The system is linked with database of mortality register, hospital withdrawals, prescriptions and assurance databases in which each individual have a unique identification number. Diagnoses in clinical practice are always registered based on IDC-9. Occurrence of CV disease was the main outcomes of interest. Risk survival analysis methods will be applied to estimate the cumulative incidence of developing CV events over time. Discussion The Escarval-Risk study will provide information to validate different cardiovascular risk scales in patients with hypertension, diabetes or dyslipidemia from a low risk Mediterranean Region, the Valencia Community.

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

    Directory of Open Access Journals (Sweden)

    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

  11. The rationale for Business English Syllabus

    Institute of Scientific and Technical Information of China (English)

    谭玉娣

    2016-01-01

    The syllabus is designed for a one-year business English course for 33 staff from Sino-Silicates Company.This rationale will analyse the arrangement of the syllabus from the following aspects:needs analysis,product-oriented,culture,in-class activity and material selection.

  12. An Expanding Rationale for Cooperative Education.

    Science.gov (United States)

    Abitia, Fred

    1985-01-01

    The author discusses cooperative education: how it is viewed by private enterprise and where it fits into higher education's framework. The cooperative education program at California Polytechnic State University is examined: faculty responsibility, rationale for the program's existence, and reasons for the program's importance. (CT)

  13. Psychological risk factors of micro- and macrovascular outcomes in primary care patients with type 2 diabetes: rationale and design of the DiaDDZoB Study

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    Pop Victor JM

    2010-07-01

    Full Text Available Abstract Background Depression is a common psychiatric complication of diabetes, but little is known about the natural course and the consequences of depressive symptoms in primary care patients with type 2 diabetes. While depression has been related to poor glycemic control and increased risk for macrovascular disease, its association with microvascular complications remains understudied. The predictive role of other psychological risk factors such as Type D (distressed personality and the mechanisms that possibly link depression and Type D personality with poor vascular outcomes are also still unclear. Methods/Design This prospective cohort study will examine: (1 the course of depressive symptoms in primary care patients with type 2 diabetes; (2 whether depressive symptoms and Type D personality are associated with the development of microvascular and/or macrovascular complications and with the risk of all-cause or vascular mortality; and (3 the behavioral and physiological mechanisms that may mediate these associations. The DiaDDZoB Study is embedded within the larger DIAZOB Primary Care Diabetes study, which covers a comprehensive cohort of type 2 diabetes patients treated by over 200 primary care physicians in South-East Brabant, The Netherlands. These patients will be followed during their lifetime and are assessed annually for demographic, clinical, lifestyle and psychosocial factors. Measurements include an interviewer-administered and self-report questionnaire, regular care laboratory tests and physical examinations, and pharmacy medication records. The DiaDDZoB Study uses data that have been collected during the original baseline assessment in 2005 (M0; N = 2,460 and the 2007 (M1; N = 2,225 and 2008 (M2; N = 2,032 follow-up assessments. Discussion The DiaDDZoB Study is expected to contribute to the current understanding of the course of depression in primary care patients with type 2 diabetes and will also test whether depressed

  14. Primary radiotherapy after tumour excision as an alternative to mastectomy for early breast cancer. Rationale and preliminary results of a prospective study.

    Science.gov (United States)

    Browde, S; Nissenbaum, M M

    1983-09-28

    A conservative approach to the management of breast cancer is gaining acceptance. The evidence from many retrospective and prospective studies indicates that breast-preserving surgery and radiation therapy give results equal to those of mastectomy. Relapse affecting the breast alone has been shown not to be detrimental to survival, while the psychological benefits to the patients have been gratifying. A prospective study of early breast cancer treated by conservative surgery and radiation was commenced at the Johannesburg Hospital in 1980. The results in 57 patients are reported. So far there have been 2 cases of local recurrence. In the majority of cases satisfactory cosmetic results were achieved. It is considered that lumpectomy with axillary dissection to establish nodal status followed by irradiation is the treatment of choice for stage I and II carcinoma of the breast.

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

    Directory of Open Access Journals (Sweden)

    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

  16. The China Patient-Centred Evaluative Assessment of Cardiac Events (China PEACE)-Prospective Study of 3-Vessel Disease: rationale and design

    Science.gov (United States)

    Rao, Chenfei; Bongiovanni, Tasce; Li, Xi; Gao, Huawei; Zhang, Heng; Li, Jing; Zhao, Yan; Yuan, Xin; Hua, Kun; Hu, Shengshou; Krumholz, Harlan M; Jiang, Lixin; Zheng, Zhe

    2016-01-01

    Introduction Complex coronary artery disease (left main and three-vessel disease) carries high risks of adverse events and cost burden. However, in China, little is known about which patients are directed toward which treatment strategies and what outcomes are being achieved. Methods and analysis Using the China PEACE (Patient-centered Evaluative Assessment of Cardiac Events) research network, this prospective study of three-Vessel Disease, the China PEACE-3VD study, has a plan to consecutively register over 4000 patients with a diagnosis of 3VD and/or left-main disease by elective coronary angiography at 24 large cardiovascular centres in China. We centrally conducted medical record abstraction and SYNTAX Score calculation for all registered patients. The sites invited patients to the prospective cohort, and conducted 1-year follow-up on major events, including cardiac events, symptoms, secondary prevention and quality of life. The estimated entire sample size of eligible patients of 4000 was determined based on both feasibility and consideration of adequate statistical precision for describing the treatment decisions, guidelines adherence and appropriateness of treatment for patients with complex coronary artery diseases. The study is designed to investigate patient, clinician and hospital factors associated with each treatment strategy (percutaneous coronary intervention, coronary artery bypass grafting or medical therapy) as well as appropriateness of treatment choice, current guideline compliance and patient-reported outcomes for patients with complex coronary artery disease in large cardiovascular centres in China, as a foundation for enhanced knowledge in the field and to assist quality improvement initiatives. Ethics and dissemination The study protocol was approved by the ethics committee at the China National Center for Cardiovascular Diseases. Findings will be shared with participating hospitals, policymakers and the academic community, to promote

  17. Two doses of rivaroxaban versus aspirin for prevention of recurrent venous thromboembolism. Rationale for and design of the EINSTEIN CHOICE study.

    Science.gov (United States)

    Weitz, Jeffrey I; Bauersachs, Rupert; Beyer-Westendorf, Jan; Bounameaux, Henri; Brighton, Timothy A; Cohen, Alexander T; Davidson, Bruce L; Holberg, Gerlind; Kakkar, Ajay; Lensing, Anthonie W A; Prins, Martin; Haskell, Lloyd; van Bellen, Bonno; Verhamme, Peter; Wells, Philip S; Prandoni, Paolo

    2015-08-31

    Patients with unprovoked venous thromboembolism (VTE) are at high risk for recurrence. Although rivaroxaban is effective for extended VTE treatment at a dose of 20 mg once daily, use of the 10 mg dose may further improve its benefit-to-risk ratio. Low-dose aspirin also reduces rates of recurrent VTE, but has not been compared with anticoagulant therapy. The EINSTEIN CHOICE study is a multicentre, randomised, double-blind, active-controlled, event-driven study comparing the efficacy and safety of two once daily doses of rivaroxaban (20 and 10 mg) with aspirin (100 mg daily) for the prevention of recurrent VTE in patients who completed 6-12 months of anticoagulant therapy for their index acute VTE event. All treatments will be given for 12 months. The primary efficacy objective is to determine whether both doses of rivaroxaban are superior to aspirin for the prevention of symptomatic recurrent VTE, while the principal safety outcome is the incidence of major bleeding. The trial is anticipated to enrol 2,850 patients from 230 sites in 31 countries over a period of 27 months. In conclusion, the EINSTEIN CHOICE study will provide new insights into the optimal antithrombotic strategy for extended VTE treatment by comparing two doses of rivaroxaban with aspirin (clinicaltrials.gov NCT02064439).

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

    Directory of Open Access Journals (Sweden)

    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

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

    Directory of Open Access Journals (Sweden)

    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

  20. Supplement use in sport: is there a potentially dangerous incongruence between rationale and practice?

    Directory of Open Access Journals (Sweden)

    Naughton Declan P

    2007-05-01

    Full Text Available Abstract Background Supplement use by athletes is complex and research supports the alarming notion of misinformed decisions regarding supplements. Hypothesis A frequent divergence between the type of supplements chosen by athletes and the rationale dictating the supplement use is hypothesized. Thus, a potentially dangerous incongruence may exist between rationale and practice. Testing the hypothesis In the continued absence of reliable data on supplement use, an alternative approach of studying the reasons underlying supplement use in athletes is proposed to determine whether there is an incongruence between rationale and practice. Existing data from large scale national surveys can be used to investigate this incongruence. Implications of the hypothesis In this report, analyses of distinctive patterns between the use and rationale for use of supplements among athletes are recommended to explore this potentially dangerous phenomenon.

  1. The Australian Twin Study of Gambling (OZ-GAM): rationale, sample description, predictors of participation, and a first look at sources of individual differences in gambling involvement.

    Science.gov (United States)

    Slutske, Wendy S; Meier, Madeline H; Zhu, Gu; Statham, Dixie J; Blaszczynski, Alex; Martin, Nicholas G

    2009-02-01

    Two major challenges to conducting a community-based twin study of pathological gambling (PG) disorder are that: (a) it is relatively rare, and (b) individuals with the disorder in the community may be difficult to locate and recruit. We describe a new study of 4,764 individuals recruited from the Australian Twin Registry in which we attempt to effectively deal with the first challenge and examine the impact of the second challenge. The lifetime prevalence of DSM-IV PG in this Australian twin sample was 2.2%, which is 400-500% higher than has been obtained in prevalence surveys conducted in the United States. A number of predictors of non-participation were identified, including a lifetime PG disorder diagnosis, but these did not have a large net effect on the estimated number of individuals with PG or related characteristics in the twin sample. Results of biometric modeling suggested that the effect of genetic, shared family environmental, and nonshared environmental influences on the propensity to engage in 11 different specific forms of gambling (e.g., playing the lottery, betting on horse or dog races, playing electronic gaming machines) were generally moderate, low, and moderate, respectively, with mean parameter estimates obtained of 43%, 10%, and 46%. An intriguing comparison with results from a 1963 US adolescent twin study conducted by Loehlin and Nichols (1976) suggests that: (a) propensity genes for gambling involvement may be more likely to be expressed in the heavy-gambling Australian culture, or that (b) the family environment has a transient effect on the gambling behavior of young people.

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

    Directory of Open Access Journals (Sweden)

    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. Rationale, design and methodology for Intraventricular Pressure Gradients Study: a novel approach for ventricular filling assessment in normal and falling hearts

    Directory of Open Access Journals (Sweden)

    Vouga Luís

    2011-05-01

    Full Text Available Abstract Background Intraventricular pressure gradients have been described between the base and the apex of the left ventricle during early diastolic ventricular filling, as well as, their increase after systolic and diastolic function improvement. Although, systolic gradients have also been observed, data are lacking on their magnitude and modulation during cardiac dysfunction. Furthermore, we know that segmental dysfunction interferes with the normal sequence of regional contraction and might be expected to alter the physiological intraventricular pressure gradients. The study hypothesis is that systolic and diastolic gradients, a marker of normal left ventricular function, may be related to physiological asynchrony between basal and apical myocardial segments and they can be attenuated, lost entirely, or even reversed when ventricular filling/emptying is impaired by regional acute ischemia or severe aortic stenosis. Methods/Design Animal Studies: Six rabbits will be completely instrumented to measuring apex to outflow-tract pressure gradient and apical and basal myocardial segments lengthening changes at basal, afterloaded and ischemic conditions. Afterload increase will be performed by abruptly narrowing or occluding the ascending aorta during the diastole and myocardial ischemia will be induced by left coronary artery ligation, after the first diagonal branch. Patient Studies: Patients between 65-80 years old (n = 12, both genders, with severe aortic stenosis referred for aortic valve replacement will be selected as eligible subjects. A high-fidelity pressure-volume catheter will be positioned through the ascending aorta across the aortic valve to measure apical and outflow-tract pressure before and after aortic valve replacement with a bioprosthesis. Peak and average intraventricular pressure gradients will be recorded as apical minus outflow-tract pressure and calculated during all diastolic and systolic phases of cardiac cycle

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

    Directory of Open Access Journals (Sweden)

    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

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

    Science.gov (United States)

    Koch, Giacomo

    2013-11-06

    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 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 l-DOPA. However, it is 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 by applying repetitive sessions of repetitive TMS (rTMS) or transcranial direct current stimulation (tDCS). The current article will provide an up-to-date overview of these issues together with some reflections on future studies in the field.

  6. Inspiratory Muscle Training and Functional Electrical Stimulation for Treatment of Heart Failure With Preserved Ejection Fraction: Rationale and Study Design of a Prospective Randomized Controlled Trial.

    Science.gov (United States)

    Palau, Patricia; Domínguez, Eloy; López, Laura; Heredia, Raquel; González, Jessika; Ramón, Jose María; Serra, Pilar; Santas, Enrique; Bodi, Vicente; Sanchis, Juan; Chorro, Francisco J; Núñez, Julio

    2016-08-01

    Heart failure with preserved ejection fraction (HFpEF) has become the most prevalent form of heart failure in developed countries. Regrettably, there is no evidence-based effective therapy for HFpEF. We seek to evaluate whether inspiratory muscle training, functional electrical stimulation, or a combination of both can improve exercise capacity as well as left ventricular diastolic function, biomarker profile, quality of life (QoL), and prognosis in patients with HFpEF. A total of 60 stable symptomatic patients with HFpEF (New York Heart Association class II-III/IV) will be randomized (1:1:1:1) to receive a 12-week program of inspiratory muscle training, functional electrical stimulation, a combination of both, or standard care alone. The primary endpoint of the study is change in peak exercise oxygen uptake; secondary endpoints are changes in QoL, echocardiogram parameters, and prognostic biomarkers. As of March 21, 2016, thirty patients have been enrolled. Searching for novel therapies that improve QoL and autonomy in the elderly with HFpEF has become a health care priority. We believe that this study will add important knowledge about the potential utility of 2 simple and feasible physical interventions for the treatment of advanced HFpEF.

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

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    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

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

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    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

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

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    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

  10. Effects of roflumilast in COPD patients receiving inhaled corticosteroid/long-acting β2-agonist fixed-dose combination: RE2SPOND rationale and study design

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    Rennard SI

    2016-08-01

    Full Text Available Stephen I Rennard,1,2 Fernando J Martinez,3,4 Klaus F Rabe,5–7 Sanjay Sethi,8 Emilio Pizzichini,9 Andrew McIvor,10 Shahid Siddiqui,11 Antonio Anzueto,12 Haiyuan Zhu13 1Department of Internal Medicine, University of Nebraska Medical Center, Omaha, NE, USA; 2AstraZeneca, Cambridge, UK; 3Joan and Sanford I Weill Department of Medicine, Weill Cornell University, New York, NY, 4Department of Internal Medicine, Michigan Health System, Ann Arbor, MI, USA; 5LungenClinic Grosshansdorf, Großhansdorf, 6Department of Medicine, University Kiel, Kiel, 7Airway Research Center North, German Center for Lung Research, Großhansdorf, Germany; 8Department of Medicine, University at Buffalo, State University of New York, Buffalo, NY, USA; 9Department of Medicine, Universidade Federal de Santa Catarina, Santa Catarina, Brazil; 10Firestone Institute of Respiratory Health, St Joseph’s Healthcare, McMaster University, Hamilton, ON, Canada; 11AstraZeneca, Gaithersburg, MD, 12South Texas Veterans Health Care System at San Antonio, University of Texas Health Science Center, San Antonio, TX, 13Allergan plc, Jersey City, NJ, USA Background: Roflumilast, a once-daily, selective phosphodiesterase-4 inhibitor, reduces the risk of COPD exacerbations in patients with severe COPD associated with chronic bronchitis and a history of exacerbations. The RE2SPOND study is examining whether roflumilast, when added to an inhaled corticosteroid/long-acting β2-agonist (ICS/LABA fixed-dose combination (FDC, further reduces exacerbations. The methodology is described herein. Methods: In this Phase IV, multicenter, double-blind, placebo-controlled, parallel-group trial, participants were randomized 1:1 (stratified by long-acting muscarinic antagonist use to receive roflumilast or placebo, plus ICS/LABA FDC, for 52 weeks. Eligible participants had severe COPD associated with chronic bronchitis, had two or more moderate–severe exacerbations within 12 months, and were receiving ICS

  11. Bridging the gap in heart failure prevention: rationale and design of the Nurse-led Intervention for Less Chronic Heart Failure (NIL-CHF) Study

    DEFF Research Database (Denmark)

    Carrington, Melinda J; Stewart, Simon; de Courten, Barbora

    2010-01-01

    AIMS: The primary objective of the Nurse-led Intervention for Less Chronic Heart Failure (NIL-CHF) Study is to develop a programme of care that cost-effectively prevents the development of chronic heart failure (CHF). Methods NIL-CHF is a randomized controlled trial of a hybrid, home- and clinic......-based, nurse-led multidisciplinary intervention targeting hospitalized patients at risk of developing CHF. A target of 750 patients aged >/=45 years will be exposed to usual post-discharge care or the NIL-CHF intervention. The composite primary endpoint is all-cause mortality or CHF-related admission during 3......-5 years of follow-up. After 12 months recruitment, approximately 300 eligible patients (40% of target) have been randomized. Overall, 73% are male and the mean age is 65 +/- 10 years. The most common antecedents for CHF thus far are hypertension (70%, 95% CI, 64-75%), coronary artery disease (51%, 95% CI...

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

    Science.gov (United States)

    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.

  13. 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

    Science.gov (United States)

    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

  14. Rationale and design of the Miami Healthy Heart Initiative: a randomized controlled study of a community health worker intervention among Latino patients with poorly controlled diabetes

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    Carrasquillo O

    2014-02-01

    Full Text Available Olveen Carrasquillo,1,2 Elizabeth Patberg,1 Yisel Alonzo,1 Hua Li,2 Sonjia Kenya1 1Department of Medicine, 2Public Health Sciences, University of Miami, Miller School of Medicine, Miami, FL, USA Background: Type 2 diabetes mellitus disproportionately affects the Latino community. Latinos with diabetes are also less likely to have adequate control of cardiovascular risk factors such as cholesterol and blood pressure. Community health workers (CHWs are increasingly being used to address various health disparity conditions, including diabetes. However, evidence of their effectiveness from randomized controlled trials is limited. Methods: The Miami Health Heart Initiative is a randomized controlled trial of 300 Latino patients with diabetes. Patients with hemoglobin A1c (HbA1c ≥8.0% were recruited from Miami-Dade's public hospital system. At baseline, all patients underwent phlebotomy, physical examination, and a structured 90-minute research interview. They were then randomized to either usual care or a CHW intervention called Cariño. For participants in the Cariño arm of the study, CHW services included assistance with nonmedical social services, health education, and patient navigation in which the CHWs serve as a bridge between patients and the health care system. These services were delivered through home visits, phone calls, and group visits. At 12 months, all subjects had a follow-up examination. The primary outcomes at 1 year are changes in systolic blood pressure, low-density lipoprotein, and HbA1c. Secondary outcomes include medication adherence, medication intensification, diabetes self-efficacy, physical activity, and self-reported fruit and vegetable intake. Discussion: The Miami Healthy Heart Initiative is one of the first rigorously conducted randomized controlled trials to provide evidence on the impact of CHWs on diabetes intermediate outcomes among Latinos. If the data support our primary hypotheses, the study would lend added

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

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    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

  16. 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.

    Science.gov (United States)

    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 30.0-45.0 kg/m(2)) to determine if weight loss (6 months) 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 6 months. 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.

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

    Directory of Open Access Journals (Sweden)

    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

  18. Effect of serial infusions of reconstituted high-density lipoprotein (CER-001) on coronary atherosclerosis: rationale and design of the CARAT study

    Science.gov (United States)

    Andrews, Jordan; Janssan, Alex; Nguyen, Tracy; Pisaniello, Anthony D.; Scherer, Daniel J.; Kastelein, John J. P.; Merkely, Bela; Nissen, Steven E.; Ray, Kausik; Schwartz, Gregory G.; Worthley, Stephen G.; Keyserling, Connie; Dasseux, Jean-Louis; Butters, Julie; Girardi, Jacinta; Miller, Rosemary

    2017-01-01

    Background High-density lipoprotein (HDL) is believed to have atheroprotective properties, but an effective HDL-based therapy remains elusive. Early studies have suggested that infusion of reconstituted HDL promotes reverse cholesterol transport and vascular reactivity. The CER-001 Atherosclerosis Regression Acute Coronary Syndrome Trial (CARAT) is investigating the impact of infusing an engineered pre-beta HDL mimetic containing sphingomyelin (SM) and dipalmitoyl phosphatidlyglycerol (CER-001) on coronary atheroma volume in patients with a recent acute coronary syndrome (ACS). Methods The CARAT is a phase 2, multicenter trial in which 292 patients with an ACS undergoing intracoronary ultrasonography and showing percent atheroma volume (PAV) greater than 30% are randomly assigned to treatment with ten infusions of CER-001 3 mg/kg or matching placebo, administered at weekly intervals. Intracoronary ultrasonography is repeated at the end of the treatment period. Results The primary endpoint is the nominal change in PAV. Safety and tolerability will also be evaluated. Conclusions CARAT will establish whether serial 3 mg/kg infusions of an engineered pre-beta HDL mimetic containing SM and dipalmitoyl phosphatidlyglycerol (CER-001) will regress atherosclerotic plaque in patients with a recent ACS. PMID:28164012

  19. The Effect of Remote Ischemic Conditioning and Glyceryl Trinitrate on Perioperative Myocardial Injury in Cardiac Bypass Surgery Patients: Rationale and Design of the ERIC-GTN Study.

    Science.gov (United States)

    Hamarneh, Ashraf; Sivaraman, Vivek; Bulluck, Heerajnarain; Shanahan, Hilary; Kyle, Bonnie; Ramlall, Manish; Chung, Robin; Jarvis, Claire; Xenou, Maria; Ariti, Cono; Cordery, Roger; Yellon, Derek M; Hausenloy, Derek J

    2015-11-01

    Remote ischemic conditioning (RIC) using transient limb ischemia/reperfusion has been reported to reduce perioperative myocardial injury in patients undergoing coronary artery bypass grafting and/or valve surgery. The role of intravenous glyceryl trinitrate (GTN) therapy administered during cardiac surgery as a cardioprotective agent and whether it interferes with RIC cardioprotection is not clear and is investigated in the ERIC-GTN trial ( http://www.clinicaltrials.gov: NCT01864252). The ERIC-GTN trial is a single-site, double-blind, randomized, placebo-controlled study. Consenting adult patients (age > 18 years) undergoing elective coronary artery bypass grafting ± valve surgery with blood cardioplegia will be eligible for inclusion. Two hundred sixty patients will be randomized to 1 of 4 treatment groups following anesthetic induction: (1) RIC alone, a RIC protocol comprising three 5-minute cycles of simultaneous upper-arm and thigh cuff inflation/deflation followed by an intravenous (IV) placebo infusion; (2) GTN alone, a simulated sham RIC protocol followed by an IV GTN infusion; (3) RIC + GTN, a RIC protocol followed by an IV GTN infusion; and (4) neither RIC nor GTN, a sham RIC protocol followed by IV placebo infusion. The primary endpoint will be perioperative myocardial injury as quantified by the 72-hour area-under-the-curve serum high-sensitivity troponin T. The ERIC-GTN trial will determine whether intraoperative GTN therapy is cardioprotective during cardiac surgery and whether it affects RIC cardioprotection.

  20. Childhood obesity prevention in rural settings: background, rationale, and study design of ‘4-Health,’ a parent-only intervention

    Directory of Open Access Journals (Sweden)

    Lynch Wesley C

    2012-04-01

    Full Text Available Abstract Background Childhood obesity in rural communities is a serious but understudied problem. The current experiment aims to assess a wide range of obesity risk factors among rural youth and to offer an 8-month intervention program for parents to reduce obesity risk in their preteen child. Methods/Design A two-group, repeated measures design is used to assess the effectiveness of the 4-Health intervention program. Assessments include anthropometric measures, child self-evaluations, parent self-evaluations, and parent evaluations of child. County Extension agents from 21 rural Montana counties recruit approximately 150 parent–child dyads and counties are semi-randomly assigned to the active intervention group (4-Health Educational Program or a “best-practices” (Healthy Living Information control group. Discussion This study will shed light on the effectiveness of this parent-only intervention strategy in reducing obesity risk factors among rural preteens. The 4-Health program is designed to provide information and skills development for busy rural parents that will increase healthy lifestyles of their preteen children and improve the parents’ ability to intervene effectively in the lives of their families during this critical developmental period. Trial registration ClinicalTrials.gov ID: NCT01510587

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

    Science.gov (United States)

    Vossen, Liv M; Schurgers, Leon J; van Varik, Bernard J; Kietselaer, Bas L J H; Vermeer, Cees; Meeder, Johannes G; Rahel, Braim M; van Cauteren, Yvonne J M; Hoffland, Ge A; Rennenberg, Roger J M W; Reesink, Koen D; de Leeuw, Peter W; Kroon, Abraham A

    2015-10-28

    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.

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

    Directory of Open Access Journals (Sweden)

    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

  3. Rationale and study design for a randomised controlled trial to reduce sedentary time in adults at risk of type 2 diabetes mellitus: project stand (Sedentary Time ANd diabetes

    Directory of Open Access Journals (Sweden)

    Wilmot Emma G

    2011-12-01

    Full Text Available Abstract Background The rising prevalence of Type 2 Diabetes Mellitus (T2DM is a major public health problem. There is an urgent need for effective lifestyle interventions to prevent the development of T2DM. Sedentary behaviour (sitting time has recently been identified as a risk factor for diabetes, often independent of the time spent in moderate-to-vigorous physical activity. Project STAND (Sedentary Time ANd Diabetes is a study which aims to reduce sedentary behaviour in younger adults at high risk of T2DM. Methods/Design A reduction in sedentary time is targeted using theory driven group structured education. The STAND programme is subject to piloting and process evaluation in line with the MRC framework for complex interventions. Participants are encouraged to self-monitor and self-regulate their behaviour. The intervention is being assessed in a randomised controlled trial with 12 month follow up. Inclusion criteria are a aged 18-40 years with a BMI in the obese range; b 18-40 years with a BMI in the overweight range plus an additional risk factor for T2DM. Participants are randomised to the intervention (n = 89 or control (n = 89 arm. The primary outcome is a reduction in sedentary behaviour at 12 months as measured by an accelerometer (count Conclusions This is the first UK trial to address sedentary behaviour change in a population of younger adults at risk of T2DM. The results will provide a platform for the development of a range of future multidisciplinary interventions in this rapidly expanding high-risk population. Trial registration Current controlled trials ISRCTN08434554, MRC project 91409.

  4. 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

    Directory of Open Access Journals (Sweden)

    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

  5. 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

    NARCIS (Netherlands)

    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

  6. Design and rationale for the PREVAIL study

    DEFF Research Database (Denmark)

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

    2012-01-01

    :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...

  7. Rationale and design of XAMOS

    DEFF Research Database (Denmark)

    Turpie, Alexander G G; Schmidt, André C; Kreutz, Reinhold;

    2012-01-01

    , 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...

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

    Directory of Open Access Journals (Sweden)

    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

  9. Rationale and design of ARTS

    DEFF Research Database (Denmark)

    Pitt, Bertram; Filippatos, Gerasimos; Gheorghiade, Mihai

    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......) are to evaluate the safety and tolerability of BAY 94-8862 in patients with heart failure associated with a reduced left ventricular ejection fraction (HFREF) and chronic kidney disease (CKD), and to examine the effects on biomarkers of cardiac and renal function. Methods ARTS is a multicentre, randomized, double....... placebo (primary endpoint) and vs. spironolactone, safety and tolerability, biomarkers of cardiac and renal function or injury, eGFR, and albuminuria. BAY 94-8862 pharmacokinetics are also assessed. Perspectives ARTS is the first phase II clinical trial of BAY 94-8862 and is expected to provide a wealth...

  10. 特发性流出道室性心律失常研究:基本原理和设计方案%Idiopathic outflow tract ventricular arrhythmias study (IOTVA Study) :rationale and design

    Institute of Scientific and Technical Information of China (English)

    曹克将; 张澍; 姚焰; 吴书林; 陈明龙; 张凤祥; 杨兵; 李小荣; 魏薇

    2014-01-01

    Background Idiopathic ventricular arrhythmias (IOTVA) in patients without structural heart disease mostly originate from left or right ventricular outflow tract.Data about the epidemiology,nature prognosis and treatment of idiopathic outflow tract premature ventricular complexes/nonsustained ventricular tachycardia (IOTPVC/NSVT),which based on the large sample of clinical trial,are scarce at present.Rationale Some studies have demonstrated that effects on cardiac function of IOTPVC/NSVT are related to its burden.Antiarrhythmic drugs (class IC agents and β-blockers) and catheter ablation are effective for IOTVA.This study will assess effects on cardiac function of IOTPVC burden and compare safety and effectiveness of antiarrhythmic drugs with catheter ablation in patients with IOTPVC/NSVT.Design The IOTVA study will includes the following:①to investigate the proportion of IOTVA to ventricular arrhythmias in outpatients and inpatients at the department of cardiology; ②to inquire the prognosis and its cardiac function in IOTVA patients without any treatment; ③to assess the safety of antiarrhythmic drugs therapy compared with control therapy in IOTVA patients; ④to compare safety and effectiveness of antiarrhythmic drugs with catheter ablation in IOTPVC/NSVT patients with PVCs burden more than 15%.Based on these studies,we would establish the clinical treatment approach for IOTVA.Conclusion IOTVA study will assess effects on cardiac function of IOTPVC burden and evaluate safety and effectiveness of antiarrhythmic drugs and catheter ablation in patients with IOTPVC/NSVT.%背景 发生在无器质性心脏病的室性心律失常又称为特发性室性心律失常(IVA),其中大多数起源于左心室或右心室流出道.目前关于特发性流出道室性早搏(IOTPVC)与非持续性室性心动过速(NSVT)的流行病学调查、预后以及临床干预均缺乏大样本的循证医学证据.基本原理 相关研究表明,不同负荷的IOTPVC/NSVT可

  11. The 'Walking for Wellbeing in the West' randomised controlled trial of a pedometer-based walking programme in combination with physical activity consultation with 12 month follow-up: rationale and study design

    Directory of Open Access Journals (Sweden)

    Ogilvie David

    2008-07-01

    Full Text Available Abstract Background Scotland has a policy aimed at increasing physical activity levels in the population, but evidence on how to achieve this is still developing. Studies that focus on encouraging real world participants to start physical activity in their settings are needed. The Walking for Well-being in the West study was designed to assess the effectiveness of a pedometer-based walking programme in combination with physical activity consultation. The study was multi-disciplinary and based in the community. Walking for Well-being in the West investigated whether Scottish men and women, who were not achieving the current physical activity recommendation, increased and maintained walking behaviour over a 12 month period. This paper outlines the rationale and design of this innovative and pragmatic study. Methods Participants were randomised into two groups: Group 1: Intervention (pedometer-based walking programme combined with a series of physical activity consultations; Group 2: Waiting list control for 12 weeks (followed by minimal pedometer-based intervention. Physical activity (primary outcome was measured using pedometer step counts (7 day and the International Physical Activity Questionnaire (long version. Psychological processes were measured using questionnaires relating to the Transtheoretical Model of Behaviour Change, mood (Positive and Negative Affect Schedule and quality of life (Euroqol EQ-5D instrument. Physiological measures included anthropometric and metabolic outcomes. Environmental influences were assessed subjectively (Neighbourhood Quality of Life Survey and objectively (neighbourhood audit tool and GIS mapping. The qualitative evaluation employed observation, semi-structured interviews and focus groups. A supplementary study undertook an economic evaluation. Discussion Data analysis is on-going. Walking for Well-being in the West will demonstrate if a pedometer based walking programme, in combination with physical

  12. Home-based exercise rehabilitation in addition to specialist heart failure nurse care: design, rationale and recruitment to the Birmingham Rehabilitation Uptake Maximisation study for patients with congestive heart failure (BRUM-CHF: a randomised controlled trial

    Directory of Open Access Journals (Sweden)

    Ingram Jackie T

    2007-03-01

    Full Text Available Abstract Background Exercise has been shown to be beneficial for selected patients with heart failure, but questions remain over its effectiveness, cost-effectiveness and uptake in a real world setting. This paper describes the design, rationale and recruitment for a randomised controlled trial that will explore the effectiveness and uptake of a predominantly home-based exercise rehabilitation programme, as well as its cost-effectiveness and patient acceptability. Methods/design Randomised controlled trial comparing specialist heart failure nurse care plus a nurse-led predominantly home-based exercise intervention against specialist heart failure nurse care alone in a multiethnic city population, served by two NHS Trusts and one primary care setting, in the United Kingdom. 169 English speaking patients with stable heart failure, defined as systolic impairment (ejection fraction ≤ 40%. with one or more hospital admissions with clinical heart failure or New York Heart Association (NYHA II/III within previous 24-months were recruited. Main outcome measures at 1 year: Minnesota Living with Heart Failure Questionnaire, incremental shuttle walk test, death or admission with heart failure or myocardial infarction, health care utilisation and costs. Interviews with purposive samples of patients to gain qualitative information about acceptability and adherence to exercise, views about their treatment, self-management of their heart failure and reasons why some patients declined to participate. The records of 1639 patients managed by specialist heart failure services were screened, of which 997 (61% were ineligible, due to ejection fraction>40%, current NYHA IV, no admission or NYHA II or more within the previous 2 years, or serious co-morbidities preventing physical activity. 642 patients were contacted: 289 (45% declined to participate, 183 (39% had an exclusion criterion and 169 (26% agreed to randomisation. Discussion Due to safety considerations

  13. A beginner's guide to writing the nursing conceptual model-based theoretical rationale.

    Science.gov (United States)

    Gigliotti, Eileen; Manister, Nancy N

    2012-10-01

    Writing the theoretical rationale for a study can be a daunting prospect for novice researchers. Nursing's conceptual models provide excellent frameworks for placement of study variables, but moving from the very abstract concepts of the nursing model to the less abstract concepts of the study variables is difficult. Similar to the five-paragraph essay used by writing teachers to assist beginning writers to construct a logical thesis, the authors of this column present guidelines that beginners can follow to construct their theoretical rationale. This guide can be used with any nursing conceptual model but Neuman's model was chosen here as the exemplar.

  14. How might acupuncture work? A systematic review of physiologic rationales from clinical trials

    Directory of Open Access Journals (Sweden)

    Moffet Howard H

    2006-07-01

    Full Text Available Abstract Background Scientific interest in acupuncture has led numerous investigators to conduct clinical trials to test the efficacy of acupuncture for various conditions, but the mechanisms underlying acupuncture are poorly understood. Methods The author conducted a PubMed search to obtain a fair sample of acupuncture clinical trials published in English in 2005. Each article was reviewed for a physiologic rationale, as well as study objectives and outcomes, experimental and control interventions, country of origin, funding sources and journal type. Results Seventy-nine acupuncture clinical trials were identified. Twenty-six studies (33% offered no physiologic rationale. Fifty-three studies (67% posited a physiologic basis for acupuncture: 33 (62% of 53 proposed neurochemical mechanisms, 2 (4% segmental nervous system effects, 6 (11% autonomic nervous system regulation, 3 (6% local effects, 5 (9% effects on brain function and 5 (9% other effects. No rationale was proposed for stroke; otherwise having a rationale was not associated with objective, positive or negative findings, means of intervention, country of origin, funding source or journal type. The dominant explanation for how acupuncture might work involves neurochemical responses and is not reported to be dependent on treatment objective, specific points, means or method of stimulation. Conclusion Many acupuncture trials fail to offer a meaningful rationale, but proposing a rationale can help investigators to develop and test a causal hypothesis, choose an appropriate control and rule out placebo effects. Acupuncture may stimulate self-regulatory processes independent of the treatment objective, points, means or methods used; this would account for acupuncture's reported benefits in so many disparate pathologic conditions.

  15. Placebo versus "standard" hypnosis rationale: attitudes, expectancies, hypnotic responses, and experiences.

    Science.gov (United States)

    Accardi, Michelle; Cleere, Colleen; Lynn, Steven Jay; Kirsch, Irving

    2013-10-01

    In this study participants were provided with either the standard rationale that accompanies the Harvard Group Scale of Hypnotic Susceptibility: A (Shor & Orne, 1962) or a rationale that presented hypnosis as a nondeceptive placebo, consistent with Kirsch's (1994) sociocognitive perspective of hypnosis. The effects of the placebo and standard rationales were highly comparable with respect to hypnotic attitudes; prehypnotic expectancies; objective, subjective, and involuntariness measures of hypnotic responding; as well as a variety of subjective experiences during hypnosis, as measured by the Phenomenology of Consciousness Inventory (Pekala, 1982). Differences among correlations were not evident when measures were compared across groups. However, indices of hypnotic responding were correlated with attitudes in the hypnosis but not the placebo condition, and, generally speaking, the link between subjective experiences during hypnosis and measures of hypnotic responding were more reliable in the placebo than the hypnosis group. Researcher findings are neutral with respect to providing support for altered state versus sociocognitive models of hypnosis.

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

    DEFF Research Database (Denmark)

    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....

  17. Looking Forward via Hindsight: A Rationale for Reviewing Our Ideological Roots.

    Science.gov (United States)

    Engels, Dennis W.

    1980-01-01

    Points to a lack of historical studies and posits a rationale for historical study of personalities, events, and ideas in the growth of guidance and counseling. The practice of extending antecedent theory through the development of the history of counseling theory ultimately improves the discipline. (Author)

  18. Oral pulsatile delivery: rationale and chronopharmaceutical formulations.

    Science.gov (United States)

    Maroni, Alessandra; Zema, Lucia; Del Curto, Maria Dorly; Loreti, Giulia; Gazzaniga, Andrea

    2010-10-15

    Oral pulsatile/delayed delivery systems are designed to elicit programmable lag phases preceding a prompt and quantitative, repeated or prolonged release of drugs. Accordingly, they draw increasing interest because of the inherent suitability for accomplishing chronotherapeutic goals, which have recently been highlighted in connection with a number of widespread chronic diseases with typical night or early-morning recurrence of symptoms (e.g. bronchial asthma, cardiovascular disease, rheumatoid arthritis, early-morning awakening). In addition, time-based colonic release can be attained when pulsatile delivery systems are properly adapted to overcome unpredictable gastric emptying and provide delay phases that would approximately match the small intestinal transit time. Oral pulsatile delivery is pursued by means of a variety of release platforms, namely reservoir, capsular and osmotic devices. The aim of the present review is to outline the rationale and main formulation strategies behind delayed-release dosage forms intended for the pharmacological treatment of chronopathologies.

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

    Science.gov (United States)

    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…

  20. The telmisartan renoprotective study from incipient nephropathy to overt nephropathy--rationale, study design, treatment plan and baseline characteristics of the incipient to overt: angiotensin II receptor blocker, telmisartan, Investigation on Type 2 Diabetic Nephropathy (INNOVATION) Study.

    Science.gov (United States)

    Makino, H; Haneda, M; Babazono, T; Moriya, T; Ito, S; Iwamoto, Y; Kawamori, R; Takeuchi, M; Katayama, S

    2005-01-01

    We planned the INNOVATION study to determine whether telmisartan, an angiotensin-2-receptor blocker, delays the progression of renal disease from incipient nephropathy to overt nephropathy in hypertensive or normotensive Japanese patients with type 2 diabetes mellitus. The INNOVATION study is a randomized, double-blind, placebo-controlled trial. Eligible patients must have incipient nephropathy (defined as a urinary albumin to creatinine ratio of 100-300 mg/g creatinine) and a serum creatinine concentration of 300 mg/g creatinine and 30% higher than the baseline on at least two consecutive visits). A total of 1855 patients have been enrolled from 160 study centres. In 527 randomized patients (28.4% of the enrolled patients), mean (SD) urinary albumin to creatinine ratio and serum creatinine concentration at baseline were 173.3 (47.2) mg/g creatinine and 0.78 (0.19) mg/dl. Sixty-eight per cent of the patients had hypertension at baseline. Mean (SD) systolic and diastolic blood pressures at baseline were 137.1 (14.6) and 77.5 (10.3) mmHg. The INNOVATION study will determine whether telmisartan, an angiotensin II receptor blocker, provides clinical benefits in hypertensive or normotensive patients with diabetes mellitus and diabetic nephropathy.

  1. 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.

    Science.gov (United States)

    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

  2. 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

    Directory of Open Access Journals (Sweden)

    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

  3. The Importance of Rationales for Internationalization at a Local Level--University and Individual

    Science.gov (United States)

    Willis, Ian; Taylor, John

    2014-01-01

    This study examines rationales for internationalization at a research intensive university in the UK. Internationalization is often described at a macro level without reaching down to explore the individual motivations that may support or constrain internationalization at a particular institution. The article argues that it is important to…

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

    Science.gov (United States)

    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…

  5. Development of regulatory technical rationale for risk monitoring program

    Energy Technology Data Exchange (ETDEWEB)

    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.

    Science.gov (United States)

    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.

  7. Rationale for combination therapy as initial treatment for hypertension.

    Science.gov (United States)

    Giles, Thomas D

    2003-01-01

    Recent hypertension guidelines recommend initiating antihypertensive therapy with a combination of two or more agents in patients whose blood pressure exceeds their appropriate blood pressure goal by 20/10 mm Hg. This recommendation is based on the knowledge that the majority of patients with blood pressures of this magnitude will not achieve sufficient blood pressure reduction with monotherapy. Further, compared with high-dose monotherapy, combination therapy is often associated with fewer adverse effects and, for this reason, may improve patient adherence. Bringing patients to blood pressure goal quickly is likely to improve clinical outcomes. This article discusses the rationale for using combination antihypertensive therapy as initial therapy for high blood pressure in selected patients and reviews data from a study of 364 high-risk patients with Stage 2 hypertension in which a fixed-dose combination product (amlodipine besylate/benazepril HCl) proved more successful as initial therapy than high-dose monotherapy (amlodipine besylate) in reducing blood pressure.

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

    CERN Document Server

    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.

  9. Rationale for Antioxidant Supplementation in Hemodialysis Patients

    Directory of Open Access Journals (Sweden)

    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.

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

    DEFF Research Database (Denmark)

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

    2009-01-01

    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 ......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...

  11. Rationale for the real-time and dynamic cell death assays using propidium iodide

    OpenAIRE

    Zhao, Hong; Oczos, Jadwiga; Janowski, Pawel; Trembecka, Dominika; Dobrucki, Jurek; Darzynkiewicz, Zbigniew; Wlodkowic, Donald

    2010-01-01

    We have recently reported an innovative approach to use charged fluorochromes such as propidium iodide (PI) in the real-time, dynamic cell viability assays. The present study was designed to provide a mechanistic rationale for the kinetic assays using cell permeability markers. Uptake of PI by live cells, effect on the cell cycle, long term proliferation capacity, DNA damage response and pharmacologic interactions with anticancer drugs were studied using both laser scanning microscopy and las...

  12. Rationale, design and organization of the Second Chinese Cardiac Study (CCS-2): a randomized trial of clopidogrel plus aspirin, and of metoprolol, among patients with suspected acute myocardial infarction. Second Chinese Cardiac Study (CCS-2) Collaborative Group.

    Science.gov (United States)

    2000-12-01

    Assessing combined anti-platelet therapy in suspected acute myocardial infarction Aspirin has been shown to be effective in the emergency treatment of acute myocardial infarction. It irreversibly inhibits platelet cyclo-oxygenase and thereby prevents the formation of the platelet aggregating agent thromboxane A2. Clopidogrel is an anti-platelet agent that acts by a different mechanism, inhibiting adenosine diphosphate-induced platelet aggregation. Simultaneous inhibition of both of these pathways might produce significantly greater anti-platelet effects than inhibition of either alone. The Second Chinese Cardiac Study (CCS-2) will reliably determine whether adding oral clopidogrel to aspirin for up to 4 weeks in hospital after suspected acute myocardial infarction can produce a greater reduction in the risk of major vascular events than can be achieved by giving aspirin alone. In order to be able to detect a further reduction of 10-15%, some 20,000-40,000 patients in over 1000 Chinese hospitals will be randomized. Assessing early beta-blocker therapy in suspected acute myocardial infarction Although over 27,000 patients have been studied previously in randomized trials of short-term beta-blocker therapy in acute myocardial infarction, the reduction in early mortality (513 (3.7%) for beta-blocker therapy deaths versus 586 (4.3%) for control deaths) was only just conventionally significant (P = 0.02) and, overall, the absolute benefits were small in the relatively low-risk patients studied. Although there might be worthwhile benefit in higher risk patients, there is currently little routine use of beta-blocker therapy in acute myocardial infarction. Hence, patients in CCS-2 will also be randomly allocated to receive metoprolol (intravenous then oral) or matching placebo for up to 4 weeks in hospital in a 2 x 2 factorial design. Such a design allows all patients to contribute fully to assessment of the separate effects of the anti-platelet regimen and the beta

  13. 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

    Directory of Open Access Journals (Sweden)

    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

  14. 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.

    Science.gov (United States)

    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

  15. Metformin and its effects on myocardial dimension and left ventricular hypertrophy in normotensive patients with coronary heart disease (the MET-REMODEL study): rationale and design of the MET-REMODEL study.

    Science.gov (United States)

    Mohan, Mohapradeep; McSwiggan, Stephen; Baig, Fatima; Rutherford, Lynn; Lang, Chim C

    2015-02-01

    Left ventricular hypertrophy (LVH) is a common and independent risk factor for cardiovascular events in patients with coronary artery disease (CAD). Controlling blood pressure is the standard approach to the management of LVH, but this is only partially effective as LVH also persists in normotensive patients. Apart from blood pressure (BP), other main risk factors associated with LVH are insulin resistance (IR) and central obesity. The diabetic medication, Metformin, reduces IR and aids weight loss and may therefore regress LVH. The MET REMODEL study will investigate the ability of Metformin to regress LVH in 64 patients with CAD. The MET-REMODEL trial is a single-center, phase IV, double blind, randomized, placebo-controlled trial to investigate the efficacy of Metformin in regression of the independent cardiac risk factor of LVH in patients with CAD who are insulin resistant. A minimum of 64 adults with a history of CAD with LVH and IR will be randomized into two groups to receive, either Metformin XL or placebo. The primary endpoint of this trial is to investigate any change in left ventricular mass index. Secondary endpoints include changes to insulin resistance measured using fasting insulin resistance index (FIRI), obesity, LV size, and function and improvement in endothelial function. A positive result will assist clinicians to identify a new mechanism for LVH regression by administering Metformin XL. This may also lead to investigating the mortality benefit of Metformin in patients with CAD and LVH.

  16. Ethnic variations in observance and rationale for postpartum sexual abstinence in Malawi.

    Science.gov (United States)

    Zulu, E M

    2001-11-01

    Using quantitative and qualitative data from three culturally heterogeneous ethnic groups in Malawi, I show that differences in postpartum sexual abstinence are closely associated with community-specific rationales for the practice, particularly differences in the definition and timing of child-strengthening rituals that couples are required to perform before resuming intercourse. Contrary to conventional wisdom, the primary rationale for abstinence in the study areas is not linked to child spacing. Among Tumbukas in the north, most women perform the ritual immediately after resuming menstruation. Among the other ethnic groups, the rituals can be performed at any time after the end of postpartum bleeding. The study underscores the utility of the complementary micro-level approach in understanding reproductive behavior in sub-Saharan Africa.

  17. Reregulation of the Swedish pharmacy sector-A qualitative content analysis of the political rationale.

    Science.gov (United States)

    Wisell, Kristin; Winblad, Ulrika; Sporrong, Sofia Kälvemark

    2015-05-01

    In 2009, a reregulation of the Swedish pharmacy sector took place, and a fundamental change in ownership and structure followed. The reregulation provides an opportunity to reveal the politicians' views on pharmacies. The aim of this study was to explore and analyze the political arguments for the reregulation of the Swedish pharmacy sector in 2009. The method used was a qualitative content analysis of written political documents regarding the reregulation. The primary rationales for the reregulation were better availability, efficiency, price pressure, and safe usage of medicines. During the preparatory work, the rationales of diversity on the market and entrepreneurship were added, while the original rationales of efficiency, price pressure, and better usage of medicines were abandoned. The reform can be seen as a typical New Public Management reform influenced by the notion that private actors are better equipped to perform public activities. The results point to that the reform was done almost solely in order to introduce private ownership in the pharmacy sector, and was not initiated in order to solve any general problems, or to enhance patient outcomes of medicine use.

  18. Rationale of Early Adopters of Fossil Fuel Divestment

    Science.gov (United States)

    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…

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

    Science.gov (United States)

    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…

  20. "ComPost": A Writing Program Newsletter and Its Rationale.

    Science.gov (United States)

    Hall, Dennis R.

    1993-01-01

    Discusses the development and rationale of "ComPost," a weekly newsletter of the Composition Program at the University of Louisville. Suggests that a vehicle like ComPost can promote the communications that contribute to accomplishing collegiality and genuine program consensus. (RS)

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

    Science.gov (United States)

    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…

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

    Science.gov (United States)

    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…

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

    NARCIS (Netherlands)

    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 manageme

  4. Stanton's "The Solitude of Self": A Rationale for Feminism.

    Science.gov (United States)

    Campbell, Karlyn Kohrs

    1980-01-01

    Examines Elizabeth Cady Stanton's speech, "The Solitude of Self," as a philosophical statement of the principles underlying the nineteenth century struggle for woman's rights in the United States. Analyzes the lyric structure and tone of the speech and its tragic, existential rationale for feminism. (JMF)

  5. Oral Health Promotion in Schools: Rationale and Evaluation

    Science.gov (United States)

    Kizito, Alex; Caitlin, Meredith; Wang, Yili; Kasangaki, Arabat; Macnab, Andrew J.

    2014-01-01

    Purpose: The purpose of this paper is to explain the rationale and potential for the WHO health promoting schools (HPS) to improve children's oral health, and describe validated quantitative methodologies and qualitative approaches to measure program impact. Design/Methodology/Approach: Critical discussion of the impact of poor oral health and…

  6. Rationale for tilted implants: FEA considerations and clinical reports.

    Science.gov (United States)

    DE Vico, G; Bonino, M; Spinelli, D; Schiavetti, R; Sannino, G; Pozzi, A; Ottria, L

    2011-07-01

    The prevalence of the elderly population, as well as life expectancy, increased in the final decades of the 20th century, as described in the World Health Organization 2004 Annual Report. The edentulous condition therefore has a negative impact on the oral health-related quality of life. Patients wearing complete dentures for many years infact, and especially in the mandible, are often unsatisfied because of the instability of the prosthesis during speaking and eating. To date dental implant treatment is well documented as a predictable treatment for partial or complete edentulism. On the other hand the rehabilitation of atrophied edentulous arches with endosseous implants (> 10 mm) in the posterior regions is often associated with anatomic problems such as bone resorption, poor bone quality, mandibular canal, and the presence of maxillary sinuses. Different procedures have been proposed to overcome these anatomic limitations. The use of tilted implants parallel to the anterior wall of the maxillary sinus or the mental foramen/inferior alveolar nerve has been proposed as a conservative solution for the treatment of the atrophic edentulous maxilla. Aim of this study was to describe, through a detailed literature review, the clinical and biomechanical rationale for tilting implants and to evaluate the long-term prognosis of immediately loaded full fixed prostheses for the treatment of edentulous patients (#35) with extreme bone atrophy rehabilited with both axial (#70) and tilted (#70) implants from 2008 to 2010. The results of the present study would suggest that this new surgical technique may reduce patient morbidity and extend the indications for immediate loading full fixed rehabilitations. This improves the predictability of treatment goal, allows for a better risk management, and provides more individual information for the patient. These are the most important aspects of this technology, which may contribute to establish higher-quality standards in

  7. Authenticating Historical Fiction: Rationale and Process

    Science.gov (United States)

    Groce, Eric; Groce, Robin

    2005-01-01

    In merging social studies education with language arts, classroom teachers are utilizing selections of historical fiction to teach critical literacy skills while also meeting social studies standards. While most of the selections used for teaching history and social studies themes are strong in terms of literary merit, they may be deficient in…

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

    Science.gov (United States)

    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…

  9. A Model Incorporating the Rationale and Purpose for Conducting Mixed-Methods Research in Special Education and beyond

    Science.gov (United States)

    Collins, Kathleen M. T.; Onwuegbuzie, Anthony J.; Sutton, Ida L.

    2006-01-01

    This article provides a typology of reasons for conducting mixed-methods research in special education. The mixed-methods research process is described along with the role of the rationale and purpose of study. The reasons given in the literature for utilizing mixed-methods research are explicated, and the limitations of these reason frameworks…

  10. Rationale and design of the AdRem study : Evaluating the effects of blood pressure lowering and intensive glucose control on vascular retinal disorders in patients with type 2 diabetes mellitus

    NARCIS (Netherlands)

    Stolk, Ronald P.; Vingerling, Johannes R.; Cruickshank, J. Kennedy; Hughes, Alun D.; Stanton, Alice; Lu Juming, [No Value; Patel, Anushka; Thom, Simon A. McG.; Grobbee, Diederick E.; Lu, J.M.

    2007-01-01

    The ADVANCE Retinal Measurements (AdRem) Study is a large intervention study evaluating the effects of target driven intensive glucose control and placebo controlled blood pressure lowering on retinal vascular changes. AdRem is a sub-study of the ADVANCE Study (Action in Diabetes and Vascular diseas

  11. Adnectin-targeted inhibitors: rationale and results.

    Science.gov (United States)

    Sachdev, Esha; Gong, Jun; Rimel, Bobbie; Mita, Monica

    2015-08-01

    Adnectins are a family of binding proteins derived from the 10th type III domain of human fibronectin (10Fn3), which is part of the immunoglobulin superfamily and normally binds integrin. The 10Fn3 has the potential for broad therapeutic applications given its structural stability, ability to be manipulated, and its abundance in the human body. The most commonly studied adnectin is CT-322, which is an inhibitor of vascular endothelial growth factor receptor-2. A bispecific adnectin, El-Tandem, has also been developed and binds to epidermal growth factor receptor and insulin-like growth factor-1 receptor simultaneously. Pre-clinical studies have shown promising results in relation to reducing tumor growth, decreasing microvessel density, and promoting normalization of tumor architecture. The phase I trial with CT-322 demonstrates relatively low toxicities. However, the phase II study done with CT-322 in recurrent glioblastoma does not reveal as promising results.

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

    Directory of Open Access Journals (Sweden)

    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.

  13. Rationale for the tinnitus retraining therapy trial

    Directory of Open Access Journals (Sweden)

    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.

  14. Defense Acquistion: Rationale for Imposing Domestic Source Restrictions.

    Science.gov (United States)

    2007-11-02

    retained the restriction for polyacrylonitrile-based carbon fiber, periscope tube forgings, bull gear ring forgings, and ship propulsion shaft...forgings 1984 Protect sensitive data Ship propulsion shaft forgings 1984 Unsettled conditions among suppliers In its reviews of industrial base... Ship Propulsion Shafts 14 14 15 16 17 Appendix III Rationale for 10 U.S.C. 2534-Imposed Restrictions Buses Chemical Weapons Antidote

  15. Scientific rationale of Saturn's in situ exploration

    CERN Document Server

    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...

  16. The rationale for targeted therapies in medulloblastoma.

    Science.gov (United States)

    MacDonald, Tobey J; Aguilera, Dolly; Castellino, Robert C

    2014-01-01

    Medulloblastoma (MB) is the most frequent malignant brain tumor in children. Patients with MB who are classified as having high-risk disease or those with recurrent disease respond poorly to current therapies and have an increased risk of MB-related mortality. Preclinical studies and molecular profiling of MB tumors have revealed upregulation or activation of several key signaling pathways such as the sonic hedgehog and WNT pathways. Although the exact mechanisms underlying MB tumorigenesis remain poorly understood, inhibiting these key pathways with molecularly targeted therapies represents an important approach to improving MB outcomes. Several molecularly targeted therapies are already under clinical investigation in MB patients. We discuss current preclinical and clinical data, as well as data from clinical trials of targeted therapies that are either ongoing or in development for MB.

  17. Troublesome Construction: The Rationale and Risks of IIRSA

    Directory of Open Access Journals (Sweden)

    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. Piezoelectric hydrogen bonding: computational screening for a design rationale.

    Science.gov (United States)

    Werling, Keith A; Griffin, Maryanne; Hutchison, Geoffrey R; Lambrecht, Daniel S

    2014-09-01

    Organic piezoelectric materials are promising targets in applications such as energy harvesting or mechanical sensors and actuators. In a recent paper (Werling, K. A.; et al. J. Phys. Chem. Lett. 2013, 4, 1365-1370), we have shown that hydrogen bonding gives rise to a significant piezoelectric response. In this article, we aim to find organic hydrogen bonded systems with increased piezo-response by investigating different hydrogen bonding motifs and by tailoring the hydrogen bond strength via functionalization. The largest piezo-coefficient of 23 pm/V is found for the nitrobenzene-aniline dimer. We develop a simple, yet surprisingly accurate rationale to predict piezo-coefficients based on the zero-field compliance matrix and dipole derivatives. This rationale increases the speed of first-principles piezo-coefficient calculations by an order of magnitude. At the same time, it suggests how to understand and further increase the piezo-response. Our rationale also explains the remarkably large piezo-response of 150 pm/V and more for another class of systems, the "molecular springs" (Marvin, C.; et al. J. Phys. Chem. C 2013, 117, 16783-16790.).

  19. 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

    DEFF Research Database (Denmark)

    Garcia, Javier; Wieneke, Heinrich; Spencker, Sebastian;

    2010-01-01

    (SNPs) are DNA sequence variations occurring when a single nucleotide in the genome differs among members of a species. A novel concept has emerged being that these common genetic variations might modify the susceptibility of a certain population to specific diseases. Thus, genetic factors may also...... 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...... centres. In the genetic part of the DISCOVERY study, candidate gene polymorphisms involved in coding of the G-protein subunits will be correlated with the occurrence of ventricular arrhythmias in patients receiving an ICD for primary prevention. Furthermore, in order to search for additional sequence...

  20. [Rationale for using nabumetone and clinical experience].

    Science.gov (United States)

    Roth, S H

    2000-01-01

    Nabumetone's position as one of the most commonly used nonsteroidal anti-inflammatory drugs (NSAIDs) in the world today is based upon over a decade of clinical experience. The popularity of this drug lies in both its unique pharmacokinetic profile and special safety features in pharmacodynamic terms. This nonacidic prodrug with an active 6-methoxy-2-naphthylacetic acid (6-MNA) metabolite has COX-2 preferential features and is also devoid of enterohepatic recirculation. It is felt that these characteristics have provided the basis for its unique long term tolerability, documented in various at-risk osteoarthritis and rheumatoid arthritis populations. The excellent tolerability of nabumetone and its 24-hour half-life, which provides the advantages of a once-daily dosage regimen, make it uniquely suitable for long term anti-inflammatory therapy in arthritis. The tolerability profile of nabumetone has also demonstrated clear cost-effectiveness advantages, as confirmed by comparative and epidemiological studies. Selective COX-2 NSAIDs are likely to prove more expensive because of the increasing costs and demands of clinical research prior to FDA approval. These higher costs may limit and influence patient access, depending on the healthcare delivery system, and many years of experience will be required to document the putative tolerability advantages of these newer COX-2 inhibitor agents. In the meantime, it is comforting that nabumetone has established such an advantageous tolerability profile together with acknowledged efficacy.

  1. Rationale, Design, and Baseline Characteristics of ARTS-DN : A Randomized Study to Assess the Safety and Efficacy of Finerenone in Patients with Type 2 Diabetes Mellitus and a Clinical Diagnosis of Diabetic Nephropathy

    NARCIS (Netherlands)

    Ruilope, Luis M.; Agarwal, Rajiv; Chan, Juliana C.; Cooper, Mark E.; Gansevoort, Ron T.; Haller, Hermann; Remuzzi, Giuseppe; Rossing, Peter; Schmieder, Roland E.; Nowack, Christina; Ferreira, Anna C.; Pieper, Alexander; Kimmeskamp-Kirschbaum, Nina; Bakris, George L.

    2014-01-01

    Background/Aims: Finerenone decreases albuminuria in patients having heart failure with reduced ejection fraction and mild-to-moderate (stage 2-3) chronic kidney disease. The MinerAlocorticoid Receptor Antagonist Tolerability Study-Diabetic Nephropathy (ARTS-DN; NCT01874431) is a multicenter, random

  2. Rationale and protocol of the MetNET-1 trial, a prospective, single center, phase II study to evaluate the activity and safety of everolimus in combination with octreotide LAR and metformin in patients with advanced pancreatic neuroendocrine tumors.

    Science.gov (United States)

    Pusceddu, Sara; de Braud, Filippo; Concas, Laura; Bregant, Cristina; Leuzzi, Livia; Formisano, Barbara; Buzzoni, Roberto

    2014-01-01

    Abnormal PI3K-AKT-mTOR pathway signalling and autocrine activation of the mTOR pathway, mediated through insulin-like growth factor-1, have been implicated in the proliferation of pancreatic neuroendocrine tumor (pNET) cells. Everolimus, an mTOR inhibitor, has shown antitumor benefit in pNETs alone and in combination with octreotide LAR in RADIANT-1 and RADIANT-3 studies. Although everolimus-based phase II/III trials have improved progression-free survival for pNET, its use has not impacted on prolonging overall survival. Metformin has recently shown some anti-cancer activity in both in vitro and in vivo studies by its indirect properties to decrease insulin and insulin-like growth factor-1 (IGF-1) levels and by its antitumour effect to promote AMPK activation and consequently inhibition to TSC1-2/mTOR complex. In light of even more retrospective evidence of metformin's anticancer activity, a prospective evaluation is required to either confirm or discard these preliminary findings. With the aim to evaluate the antiproliferative effect of metformin in combination with everolimus and octreotide LAR in pancreatic well-differentiated neuroendocrine tumor patients, a single arm, prospective, single center phase II study was designed (MetNET-1 trial, NCT 02294006). Forty-three patients are expected to be evaluated. The study is ongoing, and recruitment is estimated to be completed in August 2016. The results will be anticipated in 2017.

  3. 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.

    Science.gov (United States)

    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.

  4. 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

    Directory of Open Access Journals (Sweden)

    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.

  5. 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

    Directory of Open Access Journals (Sweden)

    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.

  6. A multicenter, prospective, randomized, controlled trial evaluating the safety and efficacy of intracoronary cell infusion mobilized with granulocyte colony-stimulating factor and darbepoetin after acute myocardial infarction: study design and rationale of the 'MAGIC cell-5-combination cytokine trial'

    Directory of Open Access Journals (Sweden)

    Yoon Jung-Han

    2011-02-01

    Full Text Available Abstract Background Bone marrow derived stem/progenitor cell transplantation after acute myocardial infarction is safe and effective for improving left ventricular systolic function. However, the improvement of left ventricular systolic function is limited. This study will evaluate novel stem/progenitor cell therapy with combination cytokine treatment of the long-acting erythropoietin analogue, darbepoetin, and granulocyte colony-stimulating factor (G-CSF in patients with acute myocardial infarction. Methods The 'MAGIC Cell-5-Combination Cytokine Trial' is a multicenter, prospective, randomized, 3-arm, controlled trial with blind evaluation of the endpoints. A total of 116 patients will randomly receive one of the following three treatments: an intravenous darbepoetin infusion and intracoronary infusion of peripheral blood stem cells mobilized with G-CSF (n = 58, an intracoronary infusion of peripheral blood stem cells mobilized with G-CSF alone (n = 29, or conventional therapy (n = 29 at phase I. Patients with left ventricular ejection fraction Discussion This is the first study to evaluate the safety and efficacy of combination cytokine based progenitor/stem cell treatment. Trial registration http://www.ClinicalTrials.gov identifier: NCT00501917.

  7. 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

    Directory of Open Access Journals (Sweden)

    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

  8. Case management for the treatment of patients with major depression in general practices – rationale, design and conduct of a cluster randomized controlled trial – PRoMPT (Primary care Monitoring for depressive Patient's Trial [ISRCTN66386086] – Study protocol

    Directory of Open Access Journals (Sweden)

    Krauth Christian

    2005-10-01

    Full Text Available Abstract Background Depression is a disorder with high prevalence in primary health care and a significant burden of illness. The delivery of health care for depression, as well as other chronic illnesses, has been criticized for several reasons and new strategies to address the needs of these illnesses have been advocated. Case management is a patient-centered approach which has shown efficacy in the treatment of depression in highly organized Health Maintenance Organization (HMO settings and which might also be effective in other, less structured settings. Methods/Design PRoMPT (PRimary care Monitoring for depressive Patients Trial is a cluster randomised controlled trial with General Practice (GP as the unit of randomisation. The aim of the study is to evaluate a GP applied case-management for patients with major depressive disorder. 70 GPs were randomised either to intervention group or to control group with the control group delivering usual care. Each GP will include 10 patients suffering from major depressive disorder according to the DSM-IV criteria. The intervention group will receive treatment based on standardized guidelines and monthly telephone monitoring from a trained practice nurse. The nurse investigates the patient's status concerning the MDD criteria, his adherence to GPs prescriptions, possible side effects of medication, and treatment goal attainment. The control group receives usual care – including recommended guidelines. Main outcome measure is the cumulative score of the section depressive disorders (PHQ-9 from the German version of the Prime MD Patient Health Questionnaire (PHQ-D. Secondary outcome measures are the Beck-Depression-Inventory, self-reported adherence (adapted from Moriskey and the SF-36. In addition, data are collected about patients' satisfaction (EUROPEP-tool, medication, health care utilization, comorbidity, suicide attempts and days out of work. The study comprises three assessment times: baseline

  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

    Directory of Open Access Journals (Sweden)

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

    Directory of Open Access Journals (Sweden)

    Eng Kee Sia

    2014-12-01

    Full Text Available 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 education industry; nonetheless it does attempt to provide a case reference offering comparative data for future study especially for alternative approaches/initiatives in higher education provision.

  11. Exploring the Rationales Expressed for Including a CSR Position to the Top Management Team

    DEFF Research Database (Denmark)

    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 longitudinal aspect. I then focus on three case companies from within this selection- H&M, Mattel, and Storebrand- whereby I employ the Weberian distinction between formal and substantive rationality to identify the rationales expressed by members of these TMTs for including a CSR position to the TMT...

  12. Visceral leishmaniasis in Brazil: rationale and concerns related to reservoir control

    Directory of Open Access Journals (Sweden)

    Guilherme Loureiro Werneck

    2014-10-01

    Full Text Available The control of zoonotic visceral leishmaniasis is a challenge, particularly in Brazil, where the disease has been gradually spreading across the country over the past 30 years. Strategies employed for decreasing the transmission risk are based on the control of vector populations and reservoirs; since humans are considered unnecessary for the maintenance of transmission. Among the adopted strategies in Brazil, the sacrifice of infected dogs is commonly performed and has been the most controversial measure. In the present study, we provide the rationale for the implementation of different control strategies targeted at reservoir populations and highlight the limitations and concerns associated with each of these strategies.

  13. 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

    Directory of Open Access Journals (Sweden)

    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

  14. Coordinated series of studies to evaluate characteristics and mechanisms of acute coronary syndromes in high-risk patients randomly assigned to enoxaparin or unfractionated heparin: design and rationale of the SYNERGY Library.

    Science.gov (United States)

    Petersen, John L; Mahaffey, Kenneth W; Becker, Richard C; Goodman, Shaun G; Kleiman, Neal S; Marian, A J; Stone, Gregg W; Lansky, Alexandra J; Lincoff, A Michael; Hazen, Stanley L; Nessel, Christopher C; Toro-Figueroa, Luis; Tate, Lynn; Reist, Craig J; Cohen, Marc; Califf, Robert M; Ferguson, James J

    2004-08-01

    Clinical trials and accompanying substudies in patients with acute coronary syndromes (ACS) have over the last several years yielded a wealth of knowledge about the pathophysiology and management of this high-risk condition. The Superior Yield of the New strategy of Enoxaparin, Revascularization, and GlYcoprotein IIb/IIIa inhibitors (SYNERGY) trial is a large-scale, randomized, controlled trial evaluating the effect of enoxaparin and unfractionated heparin on death and myocardial infarction in high-risk patients presenting with non-ST-segment elevation ACS. The SYNERGY Library has been designed as a coordinated series of investigations with simultaneous data acquisition on the same cohort of approximately 500 SYNERGY patients at 60 centers in North America. Specifically, electrocardiograms, coronary arteriograms, inflammatory markers, coagulation studies, and genetic samples will be collected and processed at core laboratory facilities, and the results will be stored in a central repository. This novel strategy for substudy investigation is unprecedented in cardiovascular clinical trials. The goal is to gain significant understanding about this patient population, discover new principles of pathophysiology, identify novel pharmacologic targets, and streamline further drug development. It is hoped that the SYNERGY Library will serve as a model for future substudy design to maximize academic insight within the framework of a large-scale, multicenter trial.

  15. 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).

    Science.gov (United States)

    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 .

  16. 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.

    Science.gov (United States)

    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.

  17. Communication style and exercise compliance in physiotherapy (CONNECT. A cluster randomized controlled trial to test a theory-based intervention to increase chronic low back pain patients’ adherence to physiotherapists’ recommendations: study rationale, design, and methods

    Directory of Open Access Journals (Sweden)

    Lonsdale Chris

    2012-06-01

    Full Text Available Abstract Background Physical activity and exercise therapy are among the accepted clinical rehabilitation guidelines and are recommended self-management strategies for chronic low back pain. However, many back pain sufferers do not adhere to their physiotherapist’s recommendations. Poor patient adherence may decrease the effectiveness of advice and home-based rehabilitation exercises. According to self-determination theory, support from health care practitioners can promote patients’ autonomous motivation and greater long-term behavioral persistence (e.g., adherence to physiotherapists’ recommendations. The aim of this trial is to assess the effect of an intervention designed to increase physiotherapists’ autonomy-supportive communication on low back pain patients’ adherence to physical activity and exercise therapy recommendations. Methods/Design This study will be a single-blinded cluster randomized controlled trial. Outpatient physiotherapy centers (N =12 in Dublin, Ireland (population = 1.25 million will be randomly assigned using a computer-generated algorithm to either the experimental or control arm. Physiotherapists in the experimental arm (two hospitals and four primary care clinics will attend eight hours of communication skills training. Training will include handouts, workbooks, video examples, role-play, and discussion designed to teach physiotherapists how to communicate in a manner that promotes autonomous patient motivation. Physiotherapists in the waitlist control arm (two hospitals and four primary care clinics will not receive this training. Participants (N = 292 with chronic low back pain will complete assessments at baseline, as well as 1 week, 4 weeks, 12 weeks, and 24 weeks after their first physiotherapy appointment. Primary outcomes will include adherence to physiotherapy recommendations, as well as low back pain, function, and well-being. Participants will be blinded to treatment allocation, as

  18. 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

    Directory of Open Access Journals (Sweden)

    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

  19. Individualized Impromptu: Rationale and a Diachronic Study of Its Effectiveness.

    Science.gov (United States)

    Shellen, Wesley N.

    Because of problems involved in traditional impromptu contests, which require contestants to speak on topics that they know little or nothing about, administrators of the Big Sky Intercollegiate Forensic Tournament at the University of Montana modified the traditional contest structure in 1969 to permit impromptu speeches on sub-topics of general…

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

    Science.gov (United States)

    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.

  1. What is the biochemical and physiological rationale for using cold-water immersion in sports recovery? A systematic review.

    Science.gov (United States)

    Bleakley, Chris M; Davison, Gareth W

    2010-02-01

    Cold-water immersion (CWI) is a popular recovery intervention after exercise. The scientific rationale is not clear, and there are no clear guidelines for its use. The aim of this review was to study the physiological and biochemical effect of short periods of CWI. A computer-based literature search, citation tracking and related articles searches were undertaken. Primary research studies using healthy human participants, immersed in cold water (sports recovery still remains unclear.

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

    Science.gov (United States)

    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.

  3. The Jupitor icy moons orbiter project: The scientific rationale

    Science.gov (United States)

    Creely, Ronald; Johnson, Torrence

    The Jupiter Icy Moons Orbiter (JIMO) is proposed by NASA as the next step in the exploration of the Jovian system following the successful Galileo project. JIMO would use nuclear-electric propulsion to deliver a highly capable scientific payload to Jupiter and go into orbit around Europa, Ganymede, and Callisto, and to conduct investigations of the Jovian system. In early 2003, a NASA Science Definition Team (SDT) was appointed to develop the scientific rationale and priorities for JIMO. The SDT, co-chaired by T. Johnson and R. Greeley, consisted of 38 scientists representing the broad scientific potential afforded by JIMO.This article summarizes the principal findings of the SDT.

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

    DEFF Research Database (Denmark)

    Borrás, Susana; Jordana, Jacint

    of 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...... sluggishness. Therefore, it is reasonable to expect transforming dynamics in regional innovation policies. Against this backdrop, the paper compares the institutional frameworks and budgetary priorities of four Spanish regions during the period 2001-2014: Catalonia, the Basque country, Galicia, and Andalusia...

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

    Directory of Open Access Journals (Sweden)

    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.

  6. New Knowledge Network Evaluation Method for Design Rationale Management

    Institute of Scientific and Technical Information of China (English)

    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.

  7. The rationale of combined radiotherapy and chemotherapy - Joint action of Castor and Pollux.

    Science.gov (United States)

    Brunner, Thomas B

    2016-08-01

    This article aims to review the rationale behind the combination of radiotherapy and chemotherapy. Theoretical concepts describing the principles of the joint effects of chemoradiotherapy are reviewed. Preclinical and clinical evidence are collected and summarised demonstrating the co-operation between the two modalities which form the mainstay of the treatment of most solid tumours. Initially, the evolution of chemoradiotherapy was mostly empirically driven which is true for both, the early studies and the experimental investigations, rather than relying on scientific rationale. To date, the revised Steel's model proposes five mechanisms, spatial cooperation, cytotoxic enhancement, biological co-operation, temporary modulation and normal tissue protection to describe the interaction between radiotherapy and chemotherapy. Chemoradiotherapy has become the standard modality for most patients with locally advanced solid tumours due to better control of loco-regional disease and prolonged survival. Gradually, molecular prediction of efficacy is integrated such as MGMT status for combining temozolomide with radiotherapy in glioblastoma. As molecular targeted drugs are ready to be taken into triple combinations with chemoradiotherapy it is crucial to have a good understanding of the mechanisms of chemoradiotherapy for the rational development of future combinations.

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

    Directory of Open Access Journals (Sweden)

    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. Regional accents: a rationale for intervening and competencies required.

    Science.gov (United States)

    Sikorski, Lorna D

    2005-05-01

    Over the past 20 years, an increasing number of speech-language pathologists have stepped into the traditional arena of English as a Second Language to address the communication needs of accented individuals. Even with the growing support of ASHA, this continues to foster opposition from fellow professionals who feel that accent intervention falls outside the scope of our practice. This controversy steps up significantly when the accents in question are not foreign, but regional. This article presents a rationale for regional accent improvement training for the adult client, positions the unique demands of regional accents within the global terminology of accent, outlines the prerequisites for trainers, reviews the basics of a valid accent assessment, and addresses some preliminary instructional issues. This author suggests that trainers look outside the field of speech pathology for relevant research. Additionally, practical applications for working professionals require a clearer understanding of the American workplace and the field of human resources (management development).

  10. Renal Denervation for Chronic Heart Failure: Background and Pathophysiological Rationale.

    Science.gov (United States)

    Böhm, Michael; Ewen, Sebastian; Mahfoud, Felix

    2017-01-01

    The activation of the sympathetic nervous system is associated with cardiovascular hospitalizations and death in heart failure. Renal denervation has been shown to effectively reduce sympathetic overdrive in certain patients with uncontrolled hypertension. Pilot trials investigating renal denervation as a potential treatment approach for heart failure were initiated. Heart failure comorbidities like obstructive sleep apnea, metabolic syndrome and arrhythmias could also be targets for renal denervation, because these occurrences are also mediated by the activation of the sympathetic nervous system. Therefore, renal denervation in heart failure is worthy of further investigation, although its effectiveness still has to be proven. Herein, we describe the pathophysiological rationale and the effect of renal denervation on surrogates of the heart failure syndrome.

  11. The new polio eradication end game: rationale and supporting evidence.

    Science.gov (United States)

    Sutter, Roland W; Platt, Lauren; Mach, Ondrej; Jafari, Hamid; Aylward, R Bruce

    2014-11-01

    Polio eradication requires the removal of all polioviruses from human populations, whether wild poliovirus or those emanating from the oral poliovirus vaccine (OPV). The Polio Eradication & Endgame Strategic Plan 2013-2018 provides a framework for interruption of wild poliovirus transmission in remaining endemic foci and lays out a plan for the new polio end game, which includes the withdrawal of Sabin strains, starting with type 2, and the introduction of inactivated poliovirus vaccine, for risk mitigation purposes. This report summarizes the rationale and evidence that supports the policy decision to switch from trivalent OPV to bivalent OPV and to introduce 1 dose of inactivated poliovirus vaccine into routine immunization schedules, and it describes the proposed implementation of this policy in countries using trivalent OPV.

  12. RATIONALE AND PROCEDURES IN THE TEACHING OF INTENSIVE READING

    Institute of Scientific and Technical Information of China (English)

    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.

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

    Science.gov (United States)

    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.

  14. Advanced control room evaluation: General approach and rationale

    Energy Technology Data Exchange (ETDEWEB)

    O' Hara, J.M. (Brookhaven National Lab., Upton, NY (USA)); Wachtel, J. (Nuclear Regulatory Commission, Washington, DC (USA))

    1991-01-01

    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.

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

    Science.gov (United States)

    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.

  16. Moral and Instrumental Rationales for Affirmative Action in Five National Contexts

    Science.gov (United States)

    Moses, Michele S.

    2010-01-01

    The author's primary aims are to clarify the differing rationales for affirmative action that have emerged in five nations--France, India, South Africa, the United States, and Brazil--and to make the case for the most compelling rationales, whether instrumentally or morally based. She examines the different social contexts surrounding the…

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

    Science.gov (United States)

    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.

  18. The Examination of Secondary Education Chemistry Curricula Published between 1957-2007 in Terms of the Dimensions of Rationale, Goals, and Subject-Matter

    Science.gov (United States)

    Pekdag, Bulent; Erol, Hilal

    2013-01-01

    Fifteen secondary education chemistry curricula published from 1957 until 2007 were examined based on the dimensions of rationale, goals, and subject matter. An examination of documents in the scope of qualitative research was carried out in the study. The goals included in the examined chemistry curricula were analyzed according to the cognitive,…

  19. Evaluating the Rationale for Affirmative Action in College Admissions: Direct and Indirect Relationships between Campus Diversity and Gains in Understanding Diverse Groups

    Science.gov (United States)

    Pike, Gary R.; Kuh, George D.; Gonyea, Robert M.

    2007-01-01

    Affirmative action in college admissions is based on the premise that a diverse student body contributes to interactions among students from different backgrounds, which are in turn positively related to desirable outcomes of college. This study evaluates the merits of this rationale for affirmative action by examining the direct and indirect…

  20. Social communication intervention for school-age children: rationale and description.

    Science.gov (United States)

    Adams, Catherine

    2005-08-01

    Children of school age with social communication problems form a growing population in need of speech-language intervention. These children have difficulty not just with interpersonal communication, which underpins peer relations, but also with oral and written aspects of the curriculum. The importance of intervention in the school years therefore cannot be underestimated. In this article, a framework and rationale for intervention based on a consideration of social communication as the interdependence of social interaction, social cognition, pragmatics, and language processing are presented. A method of intervention for children with social communication problems is described. The method is illustrated by reference to a study of children with pragmatic language impairments in the United Kingdom. Social communication impairments are not specific to one diagnostic group, and therefore the intervention framework given here is applicable to a range of children with interpersonal communication problems in the school years.

  1. Rationale for using intermittent calorie restriction as a dietary treatment for drug resistant epilepsy.

    Science.gov (United States)

    Yuen, Alan W C; Sander, Josemir W

    2014-04-01

    There has been resurgence in the use of dietary treatment, principally the classical ketogenic diet and its variants, for people with epilepsy. These diets generally require significant medical and dietician support. An effective but less restrictive dietary regimen is likely to be more acceptable and more widely used. Calorie-restricted diets appear to produce a range of biochemical and metabolic changes including reduced glucose levels, reduced inflammatory markers, increased sirtuins, increased AMPK signaling, inhibition of mTOR signaling, and increase in autophagy. There are studies in animal seizure models that suggest that these biochemical and metabolic changes may decrease ictogenesis and epileptogenesis. A calorie-restricted diet might be effective in reducing seizures in people with epilepsy. Hence, there is a sufficient rationale to undertake clinical trials to assess the efficacy and safety of calorie-restricted diets in people with epilepsy.

  2. Permanent sample plots for natural tropical forests: a rationale with special emphasis on Central Africa.

    Science.gov (United States)

    Picard, Nicolas; Magnussen, Steen; Banak, Ludovic Ngok; Namkosserena, Salomon; Yalibanda, Yves

    2010-05-01

    Permanent sample plots (PSP), where trees are individually and permanently marked, have received increased interest in Central Africa as a tool to monitor vegetation changes. Although techniques for mounting PSP in tropical forests are well known, their planning still deserves attention. This study aims at defining a rationale for determining the size and number of replicates for setting up PSP in mixed tropical forests. It considers PSP as a sampling plan to estimate a target quantity with its associated margin of error. The target quantity considered here is the stock recovery rate, which is a key parameter for forest management in Central Africa. It is computed separately for each commercial species. The number of trees to monitor for each species defines the margin of error on the stock recovery rate. The size and number of replicated plots is obtained as the solution of an optimization problem that consists in minimizing the margin of error for every species while ensuring that the mounting cost remains below a given threshold. This rationale was applied using the data from the M'Baïki experimental site in the Central African Republic. It showed that the stock recovery rate is a highly variable quantity, and that the typical cost that forest managers are prone to devote to PSP leads to high margins of error. It also showed that the size and number of replicated plots is related to the spatial pattern of trees: clustered or spatially heterogeneous patterns favor many small plots, whereas regular or spatially homogeneous patterns favor few large plots.

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

    Institute of Scientific and Technical Information of China (English)

    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.

  4. Rationale for a natural products approach to herbicide discovery.

    Science.gov (United States)

    Dayan, Franck E; Owens, Daniel K; Duke, Stephen O

    2012-04-01

    Weeds continue to evolve resistance to all the known modes of herbicidal action, but no herbicide with a new target site has been commercialized in nearly 20 years. The so-called 'new chemistries' are simply molecules belonging to new chemical classes that have the same mechanisms of action as older herbicides (e.g. the protoporphyrinogen-oxidase-inhibiting pyrimidinedione saflufenacil or the very-long-chain fatty acid elongase targeting sulfonylisoxazoline herbicide pyroxasulfone). Therefore, the number of tools to manage weeds, and in particular those that can control herbicide-resistant weeds, is diminishing rapidly. There is an imminent need for truly innovative classes of herbicides that explore chemical spaces and interact with target sites not previously exploited by older active ingredients. This review proposes a rationale for a natural-products-centered approach to herbicide discovery that capitalizes on the structural diversity and ingenuity afforded by these biologically active compounds. The natural process of extended-throughput screening (high number of compounds tested on many potential target sites over long periods of times) that has shaped the evolution of natural products tends to generate molecules tailored to interact with specific target sites. As this review shows, there is generally little overlap between the mode of action of natural and synthetic phytotoxins, and more emphasis should be placed on applying methods that have proved beneficial to the pharmaceutical industry to solve problems in the agrochemical industry.

  5. Achieving Both Creativity And Rationale: Reuse In Design With Images And Claims

    Directory of Open Access Journals (Sweden)

    D. Scott McCrickard

    2011-01-01

    Full Text Available Although designers often try to create novel designs, many designs are based on previous work. In this paper we argue for the reuse of rationale, in the form of claims, as a central activity in design, and explore how this can be used to inspire creativity. We present a design activity in which images and claims are reused to create a storyboard and illustrate how creativity and rationale complement each other. Our work serves to demonstrate that an appropriate design activity can be used to leverage creativity with the use of rationale.

  6. Using Automated Processes to Generate Test Items And Their Associated Solutions and Rationales to Support Formative Feedback

    Directory of Open Access Journals (Sweden)

    Mark Gierl

    2015-08-01

    Full Text Available Automatic item generation is the process of using item models to produce assessment tasks using computer technology. An item model is similar to a template that highlights the elements in the task that must be manipulated to produce new items. The purpose of our study is to describe an innovative method for generating large numbers of diverse and heterogeneous items along with their solutions and associated rationales to support formative feedback. We demonstrate the method by generating items in two diverse content areas, mathematics and nonverbal reasoning

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

    Directory of Open Access Journals (Sweden)

    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.

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

    Science.gov (United States)

    Bizimenyera, S E; Swan, G E; Chikoto, H; Eloff, J N

    2005-06-01

    /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.

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

    Directory of Open Access Journals (Sweden)

    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

  10. Mirtazapine in Veterinary Medicine a Pharmacological Rationale for its Application in Chronic Pain

    Directory of Open Access Journals (Sweden)

    Mario Giorgi

    2012-01-01

    Full Text Available Problem statement: Many recent studies have shown that antidepressant agents have analgesic effects in addition to their intended primary actions. The Tricyclic Antidepressants (TCAs have been recognized as an effective first-line treatment of human neuropathic pain but unfortunately they display a wide range of side effects. Recent studies have shown that Selective Serotonin Reuptake Inhibitors (SSRI also have potential analgesic effects, albeit of a lower potency compared with the TCAs. Despite this, there is a trend for their increased use, in place of TCAs, in the treatment of chronic pain. Mirtazapine, a SSRI has been recently investigated in the context of veterinary medicine. It has shown favourable pharmacokinetic profiles. Despite the fact that it has mainly been used for anorexia and as an antiemetic for veterinary patients thus far, it could be potentially useful for the treatment of a wide range of anxiety-related conditions and as an analgesic in chronic and cancer-associated pain, due to its effects on both the noradrenergic and serotonic system. Rationale for the use of mirtazapine in veterinary medicine is reviewed in light of previously published literature. Conclusion/Recommendations: Mirtazapine is proposed as a potential analgesic for use in a multidrug analgesic regime in the context of veterinary medicine. Further studies need to be performed before it is implemented in clinical practice however.

  11. 亚洲来得时治疗达标研究(ATLAS)在中国2型糖尿病管理中的潜在价值:研究原理及设计%Potential value of the Asian Treat to Target Lantus Study (ATLAS) for the type 2 diabetes management in China: the rationale and design of ATLAS

    Institute of Scientific and Technical Information of China (English)

    潘长玉代表ATLAS中国研究组

    2011-01-01

    Asia and Russia patients with type 2 diabetes mellitus.Total 554 subjects are planned for this study and 160 subjects will be recruited in China.As one of the most important participating countries,China has some special characteristics in diabetes management,such as less self monitoring of blood glucose (SMBG),fewer self-titration and preferred premixed insulin in stead of basal insulin,et al.This report is aimed to introduce the study rationale and design of ATLAS with the situation in China.Methods Subjects (40-75 years old,body mass index ≥20 kg/m2 and ≤40 kg/m2 ) with type 2 diabetes mellitus for> 2 years,suboptimally controlled ( HbA1c ≥ 7.0% and ≤ 11.0% ) with stable doses of 2 oral anti-diabetic drugs (OADs) (sulphonylureas,biguanides,alpha-glucosidase inhibitors,DPP-IV inhibitors,and metiglinides)for>3 months,and not using insulin.The subjects will be randomized either to the patient-led or the physician-led titration arm for6 months treatment of glargine plus OADs regimen,where the insulin dose will be adjusted to achieve a target fasting plasma glucose value of 110 mg/dl (6.1 mmol/L).Study endpoints:The primary endpoint will be change in mean HbA1c at 6 months from baseline.For the primary endpoint,if non-inferiority is achieved using a HbA1c 0.3% boundary,superiority test will be undertaken.Secondary endpoints will include:proportion of patients reaching the target of HbA1c <7% with or without hypoglycemia; the number of patients whose HbA1c decreases at least 10% and/or 5% ; the change of fasting plasma glucose,postprandial plasma glucose,weight,dose of insulin glargine,patient treatment satisfaction,and quality of life in the two groups.Conclusions The ATLAS trial will provide information on the relative safety and efficacy of a patient-led versus physician led titration strategy for insulin glargine-based basal insulin initiation in patients who are not controlled with two OADs.The results of the study may provide new ideas and

  12. A microhydrodynamic rationale for selection of bead size in preparation of drug nanosuspensions via wet stirred media milling.

    Science.gov (United States)

    Li, Meng; Alvarez, Paulina; Bilgili, Ecevit

    2017-04-02

    Although wet stirred media milling has proven to be a robust process for producing nanoparticle suspensions of poorly water-soluble drugs and thereby enhancing their bioavailability, selection of bead size has been largely empirical, lacking fundamental rationale. This study aims to establish such rationale by investigating the impact of bead size at various stirrer speeds on the drug breakage kinetics via a microhydrodynamic model. To this end, stable suspensions of griseofulvin, a model BCS Class II drug, were prepared using hydroxypropyl cellulose and sodium dodecyl sulfate. The suspensions were milled at four different stirrer speeds (1000-4000rpm) using various sizes (50-1500μm) of zirconia beads. Laser diffraction, SEM, and XRPD were used for characterization. Our results suggest that there is an optimal bead size that achieves fastest breakage at each stirrer speed and that it shifts to a smaller size at higher speed. Calculated microhydrodynamic parameters reveal two counteracting effects of bead size: more bead-bead collisions with less energy/force upon a decrease in bead size. The optimal bead size exhibits a negative power-law correlation with either specific energy consumption or the microhydrodynamic parameters. Overall, this study rationalizes the use of smaller beads for more energetic wet media milling.

  13. Patterns of stove use in the context of fuel-device stacking: rationale and implications.

    Science.gov (United States)

    Ruiz-Mercado, Ilse; Masera, Omar

    2015-03-01

    The implementation of clean fuel and stove programs that achieve sustained use and tangible health, environmental, and social benefits to the target populations remains a key challenge. Realization of these benefits has proven elusive because even when the promoted fuels-stoves are used in the long term they are often combined (i.e., "stacked") with the traditional ones to fulfill all household needs originally met with open fires. This paper reviews the rationale for stacking in terms of the roles of end uses, cooking tasks, livelihood strategies, and the main patterns of use resulting from them. It uses evidence from case studies in different countries and from a 1-year-long field study conducted in 100 homes in three villages of Central Mexico; outlining key implications for household fuel savings, energy use, and health. We argue for the implementation of portfolios of clean fuels, devices and improved practices tailored to local needs to broaden the use niches that stove programs can cover and to reduce residual open fire use. This allows to integrate stacking into diagnosis tools, program monitoring, evaluation schemes, and implementation strategies and establish critical actions that researchers and project planners can consider when faced with actual or potential fuel-device stacking.

  14. Taurolidine and oxidative stress: a rationale for local treatment of mesothelioma.

    Science.gov (United States)

    Aceto, N; Bertino, P; Barbone, D; Tassi, G; Manzo, L; Porta, C; Mutti, L; Gaudino, G

    2009-12-01

    Malignant mesothelioma is an asbestos-related, aggressive tumour, resistant to most anticancer therapies. Akt is a key mediator of mesothelioma cell survival and chemoresistance. This study aimed to clarify the mechanism by which taurolidine (TN), a known synthetic compound with antimicrobial and antineoplastic properties, leads to mesothelioma cell death. Apoptosis was studied by annexin V binding, cell cycle analysis, caspase-8 activation, poly(ADP-ribose) polymerase (PARP) cleavage and terminal deoxynucleotidyl transferase-mediated deoxyuridine triphosphate nick-end labelling (TUNEL). Oxidative stress was measured by nitrite production and DNA oxidative damage. Protein expression and phosphorylation were evaluated by immunoprecipitation and immunoblotting. TN induces cell death of mesothelioma cells, but not of non-neoplastic human mesothelial cells. After TN treatment of mesothelioma cells, Akt but not extracellular signal-regulated kinase (Erk) 1/2 activity is inhibited a in time- and dose-dependent manner. Protein phosphatase (PP)1alpha and PP2A are activated several hours after drug addition. Apoptosis induced by TN is driven by oxidative stress and cell exposure to sulfydryl donors, such as glutathione monoethylester and l-N-acetylcysteine, significantly reduced pro-apoptotic effects and Akt inhibition. Conversely, expression of constitutively activated Akt did not affect cytoxicity elicited by TN, which retained its ability to inhibit the kinase. TN induces mesothelioma cell death via oxidative stress, accompanied by inhibition of Akt signalling. This provides a promising molecular rationale for TN as local treatment of malignant mesothelioma.

  15. 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

    Institute of Scientific and Technical Information of China (English)

    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

  16. Mechanism of inhibition of human secretory phospholipase A2 by flavonoids: rationale for lead design

    Science.gov (United States)

    Lättig, Jens; Böhl, Markus; Fischer, Petra; Tischer, Sandra; Tietböhl, Claudia; Menschikowski, Mario; Gutzeit, Herwig O.; Metz, Peter; Pisabarro, M. Teresa

    2007-08-01

    The human secretory phospholipase A2 group IIA (PLA2-IIA) is a lipolytic enzyme. Its inhibition leads to a decrease in eicosanoids levels and, thereby, to reduced inflammation. Therefore, PLA2-IIA is of high pharmacological interest in treatment of chronic diseases such as asthma and rheumatoid arthritis. Quercetin and naringenin, amongst other flavonoids, are known for their anti-inflammatory activity by modulation of enzymes of the arachidonic acid cascade. However, the mechanism by which flavonoids inhibit Phospholipase A2 (PLA2) remained unclear so far. Flavonoids are widely produced in plant tissues and, thereby, suitable targets for pharmaceutical extractions and chemical syntheses. Our work focuses on understanding the binding modes of flavonoids to PLA2, their inhibition mechanism and the rationale to modify them to obtain potent and specific inhibitors. Our computational and experimental studies focused on a set of 24 compounds including natural flavonoids and naringenin-based derivatives. Experimental results on PLA2-inhibition showed good inhibitory activity for quercetin, kaempferol, and galangin, but relatively poor for naringenin. Several naringenin derivatives were synthesized and tested for affinity and inhibitory activity improvement. 6-(1,1-dimethylallyl)naringenin revealed comparable PLA2 inhibition to quercetin-like compounds. We characterized the binding mode of these compounds and the determinants for their affinity, selectivity, and inhibitory potency. Based on our results, we suggest C(6) as the most promising position of the flavonoid scaffold to introduce chemical modifications to improve affinity, selectivity, and inhibition of PLA2-IIA by flavonoids.

  17. A voice from the margins: Investigating the African Adventist rationale on the quest for female ordination

    Directory of Open Access Journals (Sweden)

    Rebecca J. Lagat

    2016-03-01

    Full Text Available Discussions surrounding women�s ordination reached a peak with the 60th General Conference Session (GCS 2015 of the Seventh-day Adventist (SDA Church. A report compiled by a section of delegates from the East-Central Africa Division � Biblical Research Committee indicated that this continent was not yet ready to ordain women as pastors. In light of the report, this article aims to investigate the rationale of such a stark decision. Firstly, the report shows that African Adventist women theologians were omitted from the discussions � a lack of good will from the church leadership towards the females as the majority of the membership. Secondly, the decision against ordination of women is suspect and biblically inconclusive. Through an overview of literature on a biblical missional design, the article postulates: Contextualisation and theologising are necessary for Africa, but the SDA Church must remember that globally both theology and culture are subject to the biblical guidelines, and thus to God�s missio Dei as well.Intradisciplinary and/or interdisciplinary implications: This article balances cultural contextualism and gender relations � challenging a cultural bias through a missional hermeneutic. This can lead to fairer representation of African women in Adventist church structures and reroute the equality discourse in light of the missio Dei. The study intersects with cultural theory, social analysis and biblical hermeneutics.�

  18. The Italian Consensus Conference on Pain in Neurorehabilitation: rationale and methodology

    Directory of Open Access Journals (Sweden)

    Tamburin S

    2016-05-01

    Full Text Available Stefano Tamburin,1 Stefano Paolucci,2 Francesca Magrinelli,1 Massimo Musicco,2,3 Giorgio Sandrini4,5 On behalf of the Italian Consensus Conference on Pain in Neurorehabilitation (ICCPN 1Department of Neurological, Biomedical and Movement Sciences, University of Verona, Verona, 2Santa Lucia Foundation, IRCCS, Rome, 3Institute of Biomedical Technologies (IBT National Research Council of Italy (CNR, Segrate, Milan, 4C. Mondino National Institute of Neurology Foundation, IRCCS, 5Department of Brain and Behavioural Sciences, University of Pavia, Pavia, Italy Abstract: Pain is very common in the neurorehabilitation setting, where it may not only represent a target for treatment but can also negatively influence rehabilitation procedures directly or through the side effects of painkillers. To date, there are neither guidelines nor consensus on how to assess and treat pain in neurorehabilitation. Because of the very scanty pieces of evidence on this topic, the Italian Consensus Conference on Pain in Neurorehabilitation (ICCPN was promoted under the auspices of different scientific societies. This article illustrates the rationale, methodology, and topics of the ICCPN. The recommendations of the ICCPN will offer some information on how to deal with pain in neurorehabilitation and may represent the starting point for further studies.Keywords: assessment, consensus conference, neurology, pain, rehabilitation, treatment

  19. Pomegranate Extracts in the Management of Men's Urologic Health: Scientific Rationale and Preclinical and Clinical Data

    Directory of Open Access Journals (Sweden)

    Kroeger N.

    2013-01-01

    Full Text Available Multiple strands of research provide growing evidence that diet, nutrition, and life style play a role in the development and the course of urological diseases. Numerous micronutrients and polyphenols found in soy, green tea, and many fruits and vegetables have been described to impact diseases including erectile dysfunction, benign prostatic hyperplasia, and prostate cancer. However, oftentimes these reports lack both a scientific rationale and supportive evidence base. The efficacy of pomegranate, on the other hand, in the modulation of central biological processes like inflammation, hypoxia, and oxidative stress that are important in the pathogenesis of urological maladies has been robustly demonstrated in preclinical in vitro and in vivo studies. Moreover, clinical trials have further supported its use in the treatment of several diseases, in particular in the management of prostate cancer. Herein, we critically review the scientific knowledge about the current role and future prospects for the use of pomegranate extracts in the therapy of erectile dysfunction, benign prostatic hyperplasia, and prostate cancer.

  20. A tale of two cannabinoids: the therapeutic rationale for combining tetrahydrocannabinol and cannabidiol.

    Science.gov (United States)

    Russo, Ethan; Guy, Geoffrey W

    2006-01-01

    This study examines the current knowledge of physiological and clinical effects of tetrahydrocannabinol (THC) and cannabidiol (CBD) and presents a rationale for their combination in pharmaceutical preparations. Cannabinoid and vanilloid receptor effects as well as non-receptor mechanisms are explored, such as the capability of THC and CBD to act as anti-inflammatory substances independent of cyclo-oxygenase (COX) inhibition. CBD is demonstrated to antagonise some undesirable effects of THC including intoxication, sedation and tachycardia, while contributing analgesic, anti-emetic, and anti-carcinogenic properties in its own right. In modern clinical trials, this has permitted the administration of higher doses of THC, providing evidence for clinical efficacy and safety for cannabis based extracts in treatment of spasticity, central pain and lower urinary tract symptoms in multiple sclerosis, as well as sleep disturbances, peripheral neuropathic pain, brachial plexus avulsion symptoms, rheumatoid arthritis and intractable cancer pain. Prospects for future application of whole cannabis extracts in neuroprotection, drug dependency, and neoplastic disorders are further examined. The hypothesis that the combination of THC and CBD increases clinical efficacy while reducing adverse events is supported.

  1. Rationale and Description of Right Ventricle-Protective Ventilation in ARDS.

    Science.gov (United States)

    Paternot, Alexis; Repessé, Xavier; Vieillard-Baron, Antoine

    2016-10-01

    Pulmonary vascular dysfunction is associated with ARDS and leads to increased right-ventricular afterload and eventually right-ventricular failure, also called acute cor pulmonale. Interest in acute cor pulmonale and its negative impact on outcome in patients with ARDS has grown in recent years. Right-ventricular function in these patients should be closely monitored, and this is helped by the widespread use of echocardiography in intensive care units. Because mechanical ventilation may worsen right-ventricular failure, the interaction between the lungs and the right ventricle appears to be a key factor in the ventilation strategy. In this review, a rationale for a right ventricle-protective ventilation approach is provided, and such a strategy is described, including the reduction of lung stress (ie, the limitation of plateau pressure and driving pressure), the reduction of PaCO2 , and the improvement of oxygenation. Prone positioning seems to be a crucial part of this strategy by protecting both the lungs and the right ventricle, resulting in increased survival of patients with ARDS. Further studies are required to validate the positive impact on prognosis of right ventricle-protective mechanical ventilation.

  2. Practices and rationales of community engagement with wind farms: awareness raising, consultation, empowerment

    DEFF Research Database (Denmark)

    Aitken, Mhairi; Haggett, Claire; Rudolph, David Philipp

    2016-01-01

    In light of the growing emphasis on community engagement in the literature on renewable energy planning, and given the acknowledgement of the complexity of community engagement as a concept, we conducted an empirical review of practice relating to community engagement with onshore wind farms...... in the UK, exploring what is actually happening in terms of community engagement relating to onshore wind farms, and examining the rationales underpinning approaches to community engagement. We found that a wide range of engagement methods are being used in relation to onshore wind farms across the UK......-hierarchical classification of community engagement approaches: awareness raising; consultation and empowerment. This provides a useful tool for reflecting on practices and rationales of community engagement. By considering the three approaches non-hierarchically, this model allows for an examination of how such rationales...

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

    Science.gov (United States)

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

    2017-01-01

    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

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

    Directory of Open Access Journals (Sweden)

    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.

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

    Directory of Open Access Journals (Sweden)

    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.

  6. Usage of U7 small nuclear ribonucleic acid in gene therapy of hemoglobin D Punjab disorder: Rationale?

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    Viroj Wiwanitkit

    2013-01-01

    Full Text Available Background: Hemoglobin (Hb D Punjab disorder is a congenital hemoglobinopathy described in India. It is a disorder due to defect in beta-globin gene. Materials and Methods: Here, the author assesses the possibility of U7.623 gene therapy for Hb D Punjab disorder. A standard bioinformatic analysis to study the effect of co-expression between nucleic acid sequence for human Hb D Punjab beta-globin chain and U7.623 was performed. Result: It can be seen that fully recovery of Hb function and biological process can be derived via gene ontology study. Conclusion: Here, there is a rationale to use U7 small nuclear ribonucleic acid as a possible tool for gene therapy in Hb D Punjab disorder.

  7. Physiology, regulation and multifunctional activity of the gut wall: a rationale for multicompartmental modelling

    NARCIS (Netherlands)

    Bannink, A.; Dijkstra, J.; Koopmans, S.J.; Mroz, Z.

    2006-01-01

    A rationale is given for a modelling approach to identify the mechanisms involved in the functioning and metabolic activity of tissues in the wall of the gastrointestinal tract. Maintenance and productive functions are discussed and related to the distinct compartments of the gastrointestinal tract

  8. International Student Recruitment to Universities in England: Discourse, Rationales and Globalisation

    Science.gov (United States)

    Bolsmann, Chris; Miller, Henry

    2008-01-01

    The recruitment of international students to universities in England has become a central issue in an era of globalisation for university administrators, senior managers, international offices and heads of schools and faculties. We examine the policy rationales for the recruitment of international students to England. Through the use of in-depth…

  9. Connecting agents and artifacts in CSCL: Towards a rationale of mutual shaping

    NARCIS (Netherlands)

    Overdijk, Maarten; Van Diggelen, Wouter; Kirschner, Paul A.; Baker, Michael

    2012-01-01

    Overdijk, M., Van Diggelen, W., Kirschner, P. A., & Baker, M. (2012). Connecting agents and artifacts in CSCL: Towards a rationale of mutual shaping. International Journal of Computer-Supported Collaborative Learning, 7, 193-210. doi:10.1007/s11412-012-9143-2

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

    Science.gov (United States)

    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. Laryngeal High-Speed Videoendoscopy: Rationale and Recommendation for Accurate and Consistent Terminology

    Science.gov (United States)

    Deliyski, Dimitar D.; Hillman, Robert E.; Mehta, Daryush D.

    2015-01-01

    Purpose: The authors discuss the rationale behind the term "laryngeal high-speed videoendoscopy" to describe the application of high-speed endoscopic imaging techniques to the visualization of vocal fold vibration. Method: Commentary on the advantages of using accurate and consistent terminology in the field of voice research is…

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

    Directory of Open Access Journals (Sweden)

    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.

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

    Science.gov (United States)

    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…

  14. Drug delivery for in vitro fertilization: rationale, current strategies and challenges.

    Science.gov (United States)

    Janát-Amsbury, Margit M; Gupta, Kavita M; Kablitz, Caroline D; Peterson, C Matthew

    2009-08-10

    In vitro fertilization has experienced phenomenal progress in the last thirty years and awaits the additional refinement and enhancement of medication delivery systems. Opportunity exists for the novel delivery of gonadotropins, progesterone and other adjuvants. This review highlights the rationale for various medications, present delivery methods and introduces the status of novel ideas and possibilities.

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

    NARCIS (Netherlands)

    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

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

    NARCIS (Netherlands)

    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)

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

    Science.gov (United States)

    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…

  18. Integrating the Beliefs of Dewey, Lewin, and Rogers into a Rationale for Effective Group Leadership.

    Science.gov (United States)

    Grove, Richard W.

    1992-01-01

    Presents a rationale for effective group leadership grounded in John Withall's articulation of selected beliefs of John Dewey, Kurt Lewin, and Carl Rogers. Teachers and administrators need more and better preparation in collaborative inquiry. Knowledge and skills in collaborative inquiry should undergird the successful functioning of groups of…

  19. Dolutegravir Interactions with HIV-1 Integrase-DNA: Structural Rationale for Drug Resistance and Dissociation Kinetics

    Science.gov (United States)

    DeAnda, Felix; Hightower, Kendra E.; Nolte, Robert T.; Hattori, Kazunari; Yoshinaga, Tomokazu; Kawasuji, Takashi; Underwood, Mark R.

    2013-01-01

    Signature HIV-1 integrase mutations associated with clinical raltegravir resistance involve 1 of 3 primary genetic pathways, Y143C/R, Q148H/K/R and N155H, the latter 2 of which confer cross-resistance to elvitegravir. In accord with clinical findings, in vitro drug resistance profiling studies with wild-type and site-directed integrase mutant viruses have shown significant fold increases in raltegravir and elvitegravir resistance for the specified viral mutants relative to wild-type HIV-1. Dolutegravir, in contrast, has demonstrated clinical efficacy in subjects failing raltegravir therapy due to integrase mutations at Y143, Q148 or N155, which is consistent with its distinct in vitro resistance profile as dolutegravir’s antiviral activity against these viral mutants is equivalent to its activity against wild-type HIV-1. Kinetic studies of inhibitor dissociation from wild-type and mutant integrase-viral DNA complexes have shown that dolutegravir also has a distinct off-rate profile with dissociative half-lives substantially longer than those of raltegravir and elvitegravir, suggesting that dolutegravir’s prolonged binding may be an important contributing factor to its distinct resistance profile. To provide a structural rationale for these observations, we constructed several molecular models of wild-type and clinically relevant mutant HIV-1 integrase enzymes in complex with viral DNA and dolutegravir, raltegravir or elvitegravir. Here, we discuss our structural models and the posited effects that the integrase mutations and the structural and electronic properties of the integrase inhibitors may have on the catalytic pocket and inhibitor binding and, consequently, on antiviral potency in vitro and in the clinic. PMID:24146996

  20. Dolutegravir interactions with HIV-1 integrase-DNA: structural rationale for drug resistance and dissociation kinetics.

    Directory of Open Access Journals (Sweden)

    Felix DeAnda

    Full Text Available Signature HIV-1 integrase mutations associated with clinical raltegravir resistance involve 1 of 3 primary genetic pathways, Y143C/R, Q148H/K/R and N155H, the latter 2 of which confer cross-resistance to elvitegravir. In accord with clinical findings, in vitro drug resistance profiling studies with wild-type and site-directed integrase mutant viruses have shown significant fold increases in raltegravir and elvitegravir resistance for the specified viral mutants relative to wild-type HIV-1. Dolutegravir, in contrast, has demonstrated clinical efficacy in subjects failing raltegravir therapy due to integrase mutations at Y143, Q148 or N155, which is consistent with its distinct in vitro resistance profile as dolutegravir's antiviral activity against these viral mutants is equivalent to its activity against wild-type HIV-1. Kinetic studies of inhibitor dissociation from wild-type and mutant integrase-viral DNA complexes have shown that dolutegravir also has a distinct off-rate profile with dissociative half-lives substantially longer than those of raltegravir and elvitegravir, suggesting that dolutegravir's prolonged binding may be an important contributing factor to its distinct resistance profile. To provide a structural rationale for these observations, we constructed several molecular models of wild-type and clinically relevant mutant HIV-1 integrase enzymes in complex with viral DNA and dolutegravir, raltegravir or elvitegravir. Here, we discuss our structural models and the posited effects that the integrase mutations and the structural and electronic properties of the integrase inhibitors may have on the catalytic pocket and inhibitor binding and, consequently, on antiviral potency in vitro and in the clinic.

  1. Is there a rationale for pulmonary rehabilitation following successful chemotherapy for tuberculosis?

    Directory of Open Access Journals (Sweden)

    Marcela Muñoz-Torrico

    Full Text Available ABSTRACT The role of tuberculosis as a public health care priority and the availability of diagnostic tools to evaluate functional status (spirometry, plethysmography, and DLCO determination, arterial blood gases, capacity to perform exercise, lesions (chest X-ray and CT, and quality of life justify the effort to consider what needs to be done when patients have completed their treatment. To our knowledge, no review has ever evaluated this topic in a comprehensive manner. Our objective was to review the available evidence on this topic and draw conclusions regarding the future role of the "post-tuberculosis treatment" phase, which will potentially affect several million cases every year. We carried out a non-systematic literature review based on a PubMed search using specific keywords (various combinations of the terms "tuberculosis", "rehabilitation", "multidrug-resistant tuberculosis", "pulmonary disease", "obstructive lung disease", and "lung volume measurements". The reference lists of the most important studies were retrieved in order to improve the sensitivity of the search. Manuscripts written in English, Spanish, and Russian were selected. The main areas of interest were tuberculosis sequelae following tuberculosis diagnosis and treatment; "destroyed lung"; functional evaluation of sequelae; pulmonary rehabilitation interventions (physiotherapy, long-term oxygen therapy, and ventilation; and multidrug-resistant tuberculosis.The evidence found suggests that tuberculosis is definitively responsible for functional sequelae, primarily causing an obstructive pattern on spirometry (but also restrictive and mixed patterns, and that there is a rationale for pulmonary rehabilitation. We also provide a list of variables that should be discussed in future studies on pulmonary rehabilitation in patients with post-tuberculosis sequelae.

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

    Directory of Open Access Journals (Sweden)

    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

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

    Directory of Open Access Journals (Sweden)

    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.

  4. Ethical implications of co-benefits rationale within climate change mitigation strategy

    Directory of Open Access Journals (Sweden)

    Rita Vasconcellos Oliveira

    2016-10-01

    Full Text Available Climate change mitigation effort is being translated into several actions and discourses that make collateral benefits and their rationale increasingly relevant for sustainability, in such a way that they are now a constant part of the political agenda. Taking a border and consensual perspective, co-benefits are considered here to be emerging advantages of the implementation of measures regarding the lowering of greenhouse gases.Departing from the analysis of policy documents referring to two European urban transportation strategies, the emergent co-benefits are problematized and discussed to better understand their moral aspect. Further ethical reflection is conducted after an analysis of some unintended consequences of co-benefits rationale coming from the mentioned examples. The focus is primarily on the challenges of an integrative moral justification for co-benefits and also for their role in the climate change mitigation effort. We also discuss the limitations of the current normative models that frame co-benefits rationale, from a moral viewpoint and in relation to the overall climate change mitigation strategy.In this article, we propose the concepts of well-being and freedom, as portrayed by Capabilities Approach, as possible guiding notions for the moral and social evaluation of goodness of these emergent benefits and their rationale too. Additionally, some preliminary conclusions are drawn regarding the potential of the presented concepts to favour the climate change mitigation action. Finally, a scenario is drawn where Capabilities Approach is the moral guideline for co-benefits rationale showing this way its potential in terms of enhancing climate change mitigation strategy.

  5. 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®

    Directory of Open Access Journals (Sweden)

    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

  6. Rationale, design, and baseline characteristics of a trial of prevention of cardiovascular and renal disease with Fosinopril and Pravastatin in nonhypertensive, nonhypercholesterolemic subjects with microalbuminuria (the Prevention of REnal and Vascular ENdstage Disease Intervention Trial [PREVEND IT])

    NARCIS (Netherlands)

    Diercks, GFH; Janssen, WMT; van Boven, AJ; Bak, AAA; de Jong, PE; Crijns, HJGM; van Gilst, WH

    2000-01-01

    This study describes the rationale, design, and baseline characteristics of a trial to determine whether treatment with fosinopril 20 mg/day and/or pravastatin 40 mg/day will prevent cardiovascular and renal disease in nonhypertensive (RR 10 mg/L once in an early morning spot urine and 15 to 300 mg/

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

    Science.gov (United States)

    Sun, Fei; Crisóstomo, Verónica; Báez-Díaz, Claudia; Sánchez, Francisco M

    2016-02-01

    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 α1-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.

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

    Energy Technology Data Exchange (ETDEWEB)

    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.

  9. 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.

    Science.gov (United States)

    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 oil as compared with a low-fat diet on the incidence of CHD recurrence in a long-term follow-up study.

  10. Developing a Web-Based Weight Management Program for Childhood Cancer Survivors: Rationale and Methods

    Science.gov (United States)

    Meagher, Susan; Scheurer, Michael; Folta, Sara; Finnan, Emily; Criss, Kerry; Economos, Christina; Dreyer, ZoAnn; Kelly, Michael

    2016-01-01

    Background Due to advances in the field of oncology, survival rates for children with cancer have improved significantly. However, these childhood cancer survivors are at a higher risk for obesity and cardiovascular diseases and for developing these conditions at an earlier age. Objective In this paper, we describe the rationale, conceptual framework, development process, novel components, and delivery plan of a behavioral intervention program for preventing unhealthy weight gain in survivors of childhood acute lymphoblastic leukemia (ALL). Methods A Web-based program, the Healthy Eating and Active Living (HEAL) program, was designed by a multidisciplinary team of researchers who first identified behaviors that are appropriate targets for weight management in childhood ALL survivors and subsequently developed the intervention components, following core behavioral change strategies grounded in social cognitive and self-determination theories. Results The Web-based HEAL curriculum has 12 weekly self-guided sessions to increase parents’ awareness of the potential impact of cancer treatment on weight and lifestyle habits and the importance of weight management in survivors’ long-term health. It empowers parents with knowledge and skills on parenting, nutrition, and physical activity to help them facilitate healthy eating and active living soon after the child completes intensive cancer treatment. Based on social cognitive theory, the program is designed to increase behavioral skills (goal-setting, self-monitoring, and problem-solving) and self-efficacy and to provide positive reinforcement to sustain behavioral change. Conclusions Lifestyle interventions are a priority for preventing the early onset of obesity and cardiovascular risk factors in childhood cancer survivors. Intervention programs need to meet survivors’ targeted behavioral needs, address specific barriers, and capture a sensitive window for behavioral change. In addition, they should be convenient

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

    Institute of Scientific and Technical Information of China (English)

    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.

  12. Verifying causes of death in Thailand: rationale and methods for empirical investigation

    Directory of Open Access Journals (Sweden)

    Polprasert Warangkana

    2010-05-01

    Full Text Available Abstract Background Cause-specific mortality statistics by age and sex are primary evidence for epidemiological research and health policy. Annual mortality statistics from vital registration systems in Thailand are of limited utility because about 40% of deaths are registered with unknown or nonspecific causes. This paper reports the rationale, methods, and broad results from a comprehensive study to verify registered causes in Thailand. Methods A nationally representative sample of 11,984 deaths was selected using a multistage stratified cluster sampling approach, distributed across 28 districts located in nine provinces of Thailand. Registered causes were verified through medical record review for deaths in hospitals and standard verbal autopsy procedures for deaths outside hospitals, the results of which were used to measure validity and reliability of registration data. Study findings were used to develop descriptive estimates of cause-specific mortality by age and sex in Thailand. Results Causes of death were verified for a total of 9,644 deaths in the study sample, comprised of 3,316 deaths in hospitals and 6,328 deaths outside hospitals. Field studies yielded specific diagnoses in almost all deaths in the sample originally assigned an ill-defined cause of death at registration. Study findings suggest that the leading causes of death in Thailand among males are stroke (9.4%; transport accidents (8.1%; HIV/AIDS (7.9%; ischemic heart diseases (6.4%; and chronic obstructive lung diseases (5.7%. Among females, the leading causes are stroke (11.3%; diabetes (8%; ischemic heart disease (7.5%; HIV/AIDS (5.7%; and renal diseases (4%. Conclusions Empirical investigation of registered causes of death in the study sample yielded adequate information to enable estimation of cause-specific mortality patterns in Thailand. These findings will inform burden of disease estimation and economic evaluation of health policy choices in the country. The

  13. Biofeedback therapy in cardiovascular disease: rationale and research overview.

    Science.gov (United States)

    Moravec, Christine S

    2008-03-01

    Biofeedback has much therapeutic potential in cardiovascular diseases, since many of these diseases involve dysregulation of the autonomic nervous system. Studies have clearly demonstrated that patients can use biofeedback techniques to regulate the input of the autonomic nervous system to the heart, but the clinical utility of these techniques has not been well explored in systematic trials. Much biofeedback research to date has focused on patients with hypertension, but outcomes have been inconclusive. Preliminary studies suggest that heart rate variability biofeedback may be useful in improving symptoms and quality of life in patients with cardiac disease, and early studies suggest a possible effect of biofeedback on remodeling of the failing heart. Both of these areas require further research, however. Biofeedback is increasingly used as an adjunct to stress management in cardiac rehabilitation programs, providing the impetus for a large-scale, systematic study of self-regulation in cardiac disease.

  14. 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

    Directory of Open Access Journals (Sweden)

    Jaime Jesús

    2010-03-01

    Full Text Available Abstract Background 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. Methods/Design 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

  15. 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

    Institute of Scientific and Technical Information of China (English)

    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.

  16. Brivaracetam: Rationale for discovery and preclinical profile of a selective SV2A ligand for epilepsy treatment.

    Science.gov (United States)

    Klitgaard, Henrik; Matagne, Alain; Nicolas, Jean-Marie; Gillard, Michel; Lamberty, Yves; De Ryck, Marc; Kaminski, Rafal M; Leclercq, Karine; Niespodziany, Isabelle; Wolff, Christian; Wood, Martyn; Hannestad, Jonas; Kervyn, Sophie; Kenda, Benoit

    2016-04-01

    Despite availability of effective antiepileptic drugs (AEDs), many patients with epilepsy continue to experience refractory seizures and adverse events. Achievement of better seizure control and fewer side effects is key to improving quality of life. This review describes the rationale for the discovery and preclinical profile of brivaracetam (BRV), currently under regulatory review as adjunctive therapy for adults with partial-onset seizures. The discovery of BRV was triggered by the novel mechanism of action and atypical properties of levetiracetam (LEV) in preclinical seizure and epilepsy models. LEV is associated with several mechanisms that may contribute to its antiepileptic properties and adverse effect profile. Early findings observed a moderate affinity for a unique brain-specific LEV binding site (LBS) that correlated with anticonvulsant effects in animal models of epilepsy. This provided a promising molecular target and rationale for identifying selective, high-affinity ligands for LBS with potential for improved antiepileptic properties. The later discovery that synaptic vesicle protein 2A (SV2A) was the molecular correlate of LBS confirmed the novelty of the target. A drug discovery program resulted in the identification of anticonvulsants, comprising two distinct families of high-affinity SV2A ligands possessing different pharmacologic properties. Among these, BRV differed significantly from LEV by its selective, high affinity and differential interaction with SV2A as well as a higher lipophilicity, correlating with more potent and complete seizure suppression, as well as a more rapid brain penetration in preclinical models. Initial studies in animal models also revealed BRV had a greater antiepileptogenic potential than LEV. These properties of BRV highlight its promising potential as an AED that might provide broad-spectrum efficacy, associated with a promising tolerability profile and a fast onset of action. BRV represents the first selective SV2A

  17. Selecting emergency medicine: rationales from perspective of Iranian residents.

    Directory of Open Access Journals (Sweden)

    Shervin Farahmand

    2014-12-01

    Full Text Available Emergency medicine is a relatively new specialty in Iran. Therefore, the general public and the medical community do not have enough information on its duties, capabilities, its nature, and its work schedule or its degree of occupational difficulty compared to other specialties. Hence, an insight from the early group of residents who selected this specialty can help identify the strengths and weaknesses of this field in order to promote the scientific quality of this field, and attract medical students. It can also help to alleviate deficiencies and strengthen positive aspects of emergency medicine. The aim of this study was to identify the reasons behind choosing emergency medicine as a specialty. A qualitative study was conducted using semi-structured interviews. Maximum variation opportunistic sampling was done, and face-to-face interviews were held with 23 emergency medicine residents and fellows (4 faculty members and 19 residents. Data were analyzed through thematic analysis, and categories and themes were extracted. The main levels extracted were: 1 Individual priorities, 2 the nature of work and the field of study, and 3 professional future. The themes of each main level were extracted and encoded. This study showed that the majority of residents choose emergency medicine specialty to achieve a better social and professional status in one of the most challenging fields of medicine.

  18. Phenomenological Analysis of Rationale for School Transfer Credit Policies

    Science.gov (United States)

    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…

  19. Social Science in the Schools: A Search for Rationale.

    Science.gov (United States)

    Morrissett, Irving; Stevens, W. William, Jr.

    The focus of the volume is on reasons for selecting or not selecting any particular social science content, including history, for inclusion in the elementary and secondary social studies curriculum. Prominent authors from each of the social sciences--among them, Paul Ward, David Easton, and Ronald Lippitt--describe the nature of their disciplines…

  20. Interaction Analysis in Foreign Language Teaching: A Rationale.

    Science.gov (United States)

    Swanson, Maria Antonieta Medina

    A system for observing and coding verbal interchanges between the teacher and his pupils, at all instructional levels, is described in this study. The system, widely known as the Flanders System of Interaction Analysis, is reviewed in terms of its effect on the classroom behavior of teachers and on student attitudes. The application of the…

  1. Short-Form Philadelphia Naming Test: Rationale and Empirical Evaluation

    Science.gov (United States)

    Walker, Grant M.; Schwartz, Myrna F.

    2012-01-01

    Purpose: To create two matched short forms of the Philadelphia Naming Test (PNT; Roach, Schwartz, Martin, Grewal, & Brecher, 1996) that yield similar results to the PNT for measuring anomia. Method: In Study 1, archived naming data from 94 individuals with aphasia were used to identify which PNT items should be included in the short forms. The 2…

  2. Mission objectives and scientific rationale for the magnetometer mission.

    Science.gov (United States)

    Langel, R. A.

    1991-12-01

    Based on a review of the characteristics of the geomagnetic field, objectives for the magnetic portion of the ARISTOTELES mission are: (1) To derive a description of the main magnetic field and its secular variation. (2) To investigate the correlation between the geomagnetic field and variations in the length of day. (3) To study properties of the fluid core. (4) To study the conductivity of the mantle. (5) To model the state and evolution of the crust and upper lithosphere. (6) To measure and characterize field aligned currents and ionospheric currents and to understand their generation mechanisms and their role in energy coupling in the interplanetary-magnetospheric-ionospheric systems. Procedures for these investigations are outlined.

  3. Evolutionary Rationale for Phages as Complements of Antibiotics.

    Science.gov (United States)

    Torres-Barceló, Clara; Hochberg, Michael E

    2016-04-01

    Antibiotic-resistant bacterial infections are a major concern to public health. Phage therapy has been proposed as a promising alternative to antibiotics, but an increasing number of studies suggest that both of these antimicrobial agents in combination are more effective in controlling pathogenic bacteria than either alone. We advocate the use of phages in combination with antibiotics and present the evolutionary basis for our claim. In addition, we identify compelling challenges for the realistic application of phage-antibiotic combined therapy.

  4. Reconceiving barriers for democratic health education in Danish schools: an analysis of institutional rationales

    DEFF Research Database (Denmark)

    Bruselius-Jensen, Maria; Danielsen, Dina; Laitch, Daniel

    2017-01-01

    Health promotion - and education researchers and practitioners advocate for more democratic approaches to school-based health education, including participatory teaching methods and the promotion of a broad and positive concept of health and health knowledge, including aspects of the German...... educational concept of bildung. Although Denmark, from where the data of this article are derived, has instituted policies for such approaches, their implementation in practice faces challenges. Adopting a symbolic interactionist analytical framework this paper explores and defines two powerful institutional...... rationales connected to formal and informal social processes and institutional purposes of schools, namely conservatism and Neoliberalism. It is empirically described and argued how these institutional rationales discourage teachers and students from including a broad and positive concept of health...

  5. Rationale and Design of the Access Specification Language RASP

    Directory of Open Access Journals (Sweden)

    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.

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

    DEFF Research Database (Denmark)

    Nordentoft, Merete; Jeppesen, Pia; Petersen, Lone

    2009-01-01

    and the 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......, 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...

  7. Rationale simplified hardening training and recreational complexes future teachers

    Directory of Open Access Journals (Sweden)

    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.

  8. The confusion technique untangled: its theoretical rationale and preliminary classification.

    Science.gov (United States)

    Otani, A

    1989-01-01

    This article examines the historical development of Milton H. Erickson's theoretical approach to hypnosis using confusion. Review of the literature suggests that the Confusion Technique, in principle, consists of a two-stage "confusion-restructuring" process. The article also attempts to categorize several examples of confusion suggestions by seven linguistic characteristics: (1) antonyms, (2) homonyms, (3) synonyms, (4) elaboration, (5) interruption, (6) echoing, and (7) uncommon words. The Confusion Technique is an important yet little studied strategy developed by Erickson. More work is urged to investigate its nature and properties.

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

    Science.gov (United States)

    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.

  10. Mechanistic rationales for targeting interleukin-17A in spondyloarthritis.

    Science.gov (United States)

    Raychaudhuri, Siba P; Raychaudhuri, Smriti K

    2017-03-08

    The term spondyloarthritis (SpA) is used to describe a group of inflammatory autoimmune diseases, including ankylosing spondylitis and psoriatic arthritis, with common genetic risk factors and clinical features. SpA is clinically distinct from rheumatoid arthritis and typically affects the spine, sacroiliac joints, entheses, and, less commonly, peripheral joints. Although the pathogenesis of SpA is not fully understood, recent findings have identified the interleukin (IL)-17 pathway as a key mediator of disease pathogenesis. Clinical evidence for the efficacy of IL-17A inhibition by biologic agents was initially shown in patients with chronic plaque psoriasis, another autoimmune disease mediated by the IL-17 pathway. Subsequently, similar positive efficacy for inhibition of IL-17A was seen in patients with ankylosing spondylitis and psoriatic arthritis. Inhibition of IL-17A may also improve cardiovascular and metabolic comorbidities often found in patients with SpA because studies have linked these disorders to the IL-17 pathway. In this review, we will examine key preclinical studies that demonstrated the mechanistic role of IL-17A in the development SpA and discuss how these observations were translated into clinical practice.

  11. Structure-based rationale for interleukin 5 receptor antagonism.

    Science.gov (United States)

    Ishino, Tetsuya; Harrington, Adrian E; Gopi, Hosahudya; Chaiken, Irwin

    2008-01-01

    Human interleukin 5 (IL5) is the major hematopoietin that stimulates the proliferation, migration and activation of eosinophils and is implicated in the pathogenesis of inflammatory and other myeloproliferative diseases. IL5 functions through the signaling of a common receptor subunit beta (beta c), in a receptor activation process that requires initial recruitment of an IL5 specific receptor subunit alpha (IL5Ralpha), for cytokine presentation to beta c. Important advances have been made to understand molecular mechanisms of cytokine recognition and receptor antagonism. Mutational studies indicate that a pair of charge complementary regions play an essential role in specific interaction between IL5Ralpha and IL5. Moreover, peptide studies with the IL5 system have identified a cyclic peptide inhibitor, AF17121, which binds specifically to IL5Ralpha by mimicking the cytokine. A key receptor-recognition pharmacophore has been identified in this peptide inhibitor, and sites of inhibitor recognition can be proposed in the homology-deduced structural model of IL5Ralpha. These results provide an experimental platform to derive enhanced-potency peptidomimetic inhibitors. Such inhibitors have potential use as tools to evaluate the role of eosinophilia in disease and as potential leads to antagonists to treat hyper-eosinophilic diseases such as eosinophilic esophagitis, asthma and chronic myeloproliferative leukemias.

  12. Railway regulation in 19th Century Britain: the economic rationale and legacy of Gladstone and Chadwick

    OpenAIRE

    Bailey, Mark F

    2003-01-01

    This paper examines the economic rationale of the ideas of Gladstone & Chadwick on railway regulation and the legacy of their ideas. In 1844 Gladstone proposed and implemented what we would now call price and quantity regulation whereas in 1859 Chadwick proposed competition "for the field", i.e. the establishment of a temporary monopoly or franchise, for a given period. The thinking of Gladstone had been influenced by the classical school of economic thought, most notably J R McCulloch, whils...

  13. A Rationale for Tying Merchants' Membership of Platforms Serving Independent Markets

    OpenAIRE

    King, Michael

    2011-01-01

    A Rationale for Tying Merchants' Membership of Platforms Serving Independent Markets. This thesis was submitted to the University of Manchester for the degree of Doctor of Social Sciences in the Faculty of Humanities by Michael King during September 2010. I analyses the effect of tying sellers' membership of a monopoly platform to membership of another platform, which operates in an otherwise competitive market. Visa's contentious use of the honour-all-cards rule to tie their debit and cr...

  14. Rationale in diagnosis and screening of atrophic gastritis with stomach-specific plasma biomarkers

    OpenAIRE

    Agréus, Lars; Kuipers, Ernst J; Kupcinskas, Limas; Malfertheiner, Peter; Di Mario, Francesco; Leja, Marcis; Mahachai, Varocha; Yaron, Niv; Van Oijen, Martijn; Perez, Guillermo Perez; Rugge, Massimo; Ronkainen, Jukka; Salaspuro, Mikko; Sipponen, Pentti; Sugano, Kentaro

    2012-01-01

    Background and aims Atrophic gastritis (AG) results most often from Helicobacter pylori (H. pylori) infection. AG is the most important single risk condition for gastric cancer that often leads to an acid-free or hypochlorhydric stomach. In the present paper, we suggest a rationale for noninvasive screening of AG with stomach-specific biomarkers. Methods The paper summarizes a set of data on application of the biomarkers and describes how the test results could be interpreted in practice. Res...

  15. Developing a Web-Based Weight Management Program for Childhood Cancer Survivors: Rationale and Methods

    OpenAIRE

    2016-01-01

    Background Due to advances in the field of oncology, survival rates for children with cancer have improved significantly. However, these childhood cancer survivors are at a higher risk for obesity and cardiovascular diseases and for developing these conditions at an earlier age. Objective In this paper, we describe the rationale, conceptual framework, development process, novel components, and delivery plan of a behavioral intervention program for preventing unhealthy weight gain in survivors...

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

    Energy Technology Data Exchange (ETDEWEB)

    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. Very large database of lipids: rationale and design.

    Science.gov (United States)

    Martin, Seth S; Blaha, Michael J; Toth, Peter P; Joshi, Parag H; McEvoy, John W; Ahmed, Haitham M; Elshazly, Mohamed B; Swiger, Kristopher J; Michos, Erin D; Kwiterovich, Peter O; Kulkarni, Krishnaji R; Chimera, Joseph; Cannon, Christopher P; Blumenthal, Roger S; Jones, Steven R

    2013-11-01

    Blood lipids have major cardiovascular and public health implications. Lipid-lowering drugs are prescribed based in part on categorization of patients into normal or abnormal lipid metabolism, yet relatively little emphasis has been placed on: (1) the accuracy of current lipid measures used in clinical practice, (2) the reliability of current categorizations of dyslipidemia states, and (3) the relationship of advanced lipid characterization to other cardiovascular disease biomarkers. To these ends, we developed the Very Large Database of Lipids (NCT01698489), an ongoing database protocol that harnesses deidentified data from the daily operations of a commercial lipid laboratory. The database includes individuals who were referred for clinical purposes for a Vertical Auto Profile (Atherotech Inc., Birmingham, AL), which directly measures cholesterol concentrations of low-density lipoprotein, very low-density lipoprotein, intermediate-density lipoprotein, high-density lipoprotein, their subclasses, and lipoprotein(a). Individual Very Large Database of Lipids studies, ranging from studies of measurement accuracy, to dyslipidemia categorization, to biomarker associations, to characterization of rare lipid disorders, are investigator-initiated and utilize peer-reviewed statistical analysis plans to address a priori hypotheses/aims. In the first database harvest (Very Large Database of Lipids 1.0) from 2009 to 2011, there were 1 340 614 adult and 10 294 pediatric patients; the adult sample had a median age of 59 years (interquartile range, 49-70 years) with even representation by sex. Lipid distributions closely matched those from the population-representative National Health and Nutrition Examination Survey. The second harvest of the database (Very Large Database of Lipids 2.0) is underway. Overall, the Very Large Database of Lipids database provides an opportunity for collaboration and new knowledge generation through careful examination of granular lipid data on

  18. RATIONALE FOR CENTERING CAPACITY OF REDISIGNED BELT CONVEYOR DRUMS

    Directory of Open Access Journals (Sweden)

    V. V. Suglobov

    2016-02-01

    Full Text Available Purpose. In the study is necessary: 1 to justify aligning drums of a new design of belt conveyors; 2 to develop a method for calculating and determining the rational design parameters of drums depending on the technical parameters of the conveyor belt (the length of the conveyor, belt width, the performance of the conveyor, the diameter of the drive and tension drums, etc.; 3 to carry out pilot studies of efficiency conveyor belt in a production environment in order to determine the magnitude of dynamic loads and a comparative evaluation of the effectiveness of the centering ability of conventional and new designs of drums. Methodology. To substantiate the effectiveness of the centering ability of the drums of a new design by the authors developed a mathematical model of interaction of the tape with the drum. Mathematical simulation of tape reels with new design comes to drawing up a differential equation of the belt based on the dynamic component and restoring force. This model allowed us to estimate the movement of the tape in the transverse direction based on the calculated additional dynamic loads and forces on the investigated centering a conveyor belt with given specifications. For the first time the technique of calculating and determining the rational parameters of the drums, which allows determining the design parameters of the centering portions, depending on the mechanical properties and geometric parameters of the tape. Findings. With the help of mathematical modeling the scientifically substantiated effect of centering the ability of the new design of the drum, which ensures stable tape running along the longitudinal axis of the conveyor. The authors made the following conclusions: 1 the mathematical model of interaction with the new belt design of the drum, which allowed to describe the belt in the transverse direction in view of additional dynamic loads and renewable power was developed; 2 the method of calculation and

  19. Carotid artery stenting: Rationale, technique, and current concepts

    Energy Technology Data Exchange (ETDEWEB)

    Yilmaz, Hasan, E-mail: hasan.yilmaz@hcuge.c [Department of Interventional and Diagnostic Neuroradiology, University Hospital of Geneva (Switzerland); Pereira, Vitor Mendes; Narata, Ana-Paula [Department of Interventional and Diagnostic Neuroradiology, University Hospital of Geneva (Switzerland); Sztajzel, Roman [Department of Neurology, University Hospital of Geneva (Switzerland); Lovblad, Karl-Olof [Department of Interventional and Diagnostic Neuroradiology, University Hospital of Geneva (Switzerland)

    2010-07-15

    Carotid stenosis is a major risk factor for stroke. With the aging of the general population and the availability of non-invasive vascular imaging studies, the diagnosis of a carotid plaque is commonly made in medical practice. Asymptomatic and symptomatic carotid stenoses need to be considered separately because their natural history is different. Two large randomized controlled trials (RCTs) showed the effectiveness of carotid endarterectomy (CEA) in preventing ipsilateral ischemic events in patients with symptomatic severe stenosis. The benefit of surgery is much less for moderate stenosis and harmful in patients with stenosis less than 50%. Surgery has a marginal benefit in patients with asymptomatic stenosis. Improvements in medical treatment must be taken into consideration when interpreting the results of these previous trials which compared surgery against medical treatment available at the time the trials were conducted. Carotid artery stenting (CAS) might avoid the risks associated with surgery, including cranial nerve palsy, myocardial infarction, or pulmonary embolism. Therefore and additionally to well-established indications of CAS, this endovascular approach might be a valid alternative particularly in patients at high surgical risk. However, trials of endovascular treatment of carotid stenosis have failed to provide enough evidence to justify routine CAS as an alternative to CEA in patients suitable for surgery. More data from ongoing randomized trials of CEA versus CAS will be soon available. These results will help determining the role of CAS in the management of patients with carotid artery stenosis.

  20. Rationale for anti-OX40 cancer immunotherapy.

    Science.gov (United States)

    Aspeslagh, Sandrine; Postel-Vinay, Sophie; Rusakiewicz, Sylvie; Soria, Jean-Charles; Zitvogel, Laurence; Marabelle, Aurélien

    2016-01-01

    Immune checkpoint blockade with antagonistic monoclonal antibodies (mAbs) targeting B7 immunoglobulin superfamily molecules (CTLA-4, PD-1, and PD-L1) generate long lasting anti-tumour immune responses translating into clinical benefit across many cancer types. However, many patients are primarily resistant to immune checkpoint blockade -based monotherapy and many others will eventually relapse. Therefore, new immunostimulatory targets are needed to overcome primary and secondary resistance to immunotherapy. Besides the B7 co-inhibitory receptors, the tumour necrosis factor receptor superfamily contains many other immune checkpoints, which could become the next generation immunomodulators. Among them stands OX40 (CD134), a co-stimulatory molecule that can be expressed by activated immune cells. Several anti-OX40 agonistic monoclonal antibodies are currently tested in early phase cancer clinical trials. Accumulating preclinical evidence supports their clinical development. However, conflicting results and controversies between in vitro and in vivo data point to the need for comprehensive ancillary studies to be performed in upcoming clinical trials to better understand the mechanism of action of anti-OX40 mAbs-based therapy.

  1. The rationale of pharmacoeconomic analysis in rheumatologic indications.

    Science.gov (United States)

    Turchetti, Giuseppe; Scalone, Luciana; Della Casa Alberighi, Ornella; Mosca, Marta; Montella, Sabato; Cortesi, Paolo A; Mantovani, Lorenzo G

    2012-01-01

    Pharmacoeconomic analysis is aimed at supporting choices between alternatives available for the efficient management of specific conditions. Aim of the paper is to provide an overview of the main features of pharmacoeconomic evaluations, with the objective of providing the reader with the basic tools necessary to read and interpret or to design and conduct a pharmacoeconomic analysis in RA and in other rheumatic diseases. The paragraphs will cover in detail the definition of health economic evaluation and pharmacoeconomics, the alternatives to be compared, the perspective of the analysis, costs and effects (presenting in detail direct costs and effects, indirect costs and effects, intangible costs and effects and source of data), and pharmacoeconomic techniques. Pharmacoeconomic analyses have to be conducted accurately to provide valuable information to guide the choice of options representing the best value for money without compromising the quality of care delivered. For this reason, as these analyses generally present some limitations, a very close and strong relationship between pharmacoeconomists and clinicians is crucial both in the design of pharmacoeconomic studies and in the interpretation of their results, and also in the development of more satisfactory methods and indicators.

  2. Measurement of adolescent smoking behavior: rationale and methods.

    Science.gov (United States)

    Pechacek, T F; Murray, D M; Luepker, R V; Mittelmark, M B; Johnson, C A; Shutz, J M

    1984-03-01

    The initiation of cigarette smoking among adolescents is a health problem which has been the subject of discussion and study for many years. The evaluation of strategies to deter the adoption of smoking has long been hampered by the problems of measuring adolescent smoking behavior. Recently, interest has increased in biochemical measures of smoking under the assumption that they are more objective measures. The validity of this assumption is addressed for several ages of adolescents. This paper presents saliva thiocyanate levels, expired air carbon monoxide levels, and smoking self-reports from a sample of 2200 junior and senior high-school students. Interrelationships among the biochemical and behavioral measures are strong among the total population, ranging from 0.48 to 0.95 (Pearson r) but are much weaker at the younger age levels. Normative levels of carbon monoxide and saliva thiocyanate are presented by age (11-13, 14-15, and 16-17 years old). These data indicate that habitual smoking appears to develop in a gradual fashion and that several years may pass between initial experimentation and adult levels of smoking. Younger students consistently display lower levels of thiocyanate and carbon monoxide than older students of the same self-reported levels of smoking, suggesting that inhalation patterns may vary as a function of age or years smoking.

  3. A Rationale for Age-Adapted Immunosuppression in Organ Transplantation.

    Science.gov (United States)

    Krenzien, Felix; ElKhal, Abdallah; Quante, Markus; Rodriguez Cetina Biefer, Hector; Hirofumi, Uehara; Gabardi, Steven; Tullius, Stefan G

    2015-11-01

    Demographic changes are associated with a steady increase of older patients with end-stage organ failure in need for transplantation. As a result, the majority of transplant recipients are currently older than 50 years, and organs from elderly donors are more frequently used. Nevertheless, the benefit of transplantation in older patients is well recognized, whereas the most frequent causes of death among older recipients are potentially linked to side effects of their immunosuppressants.Immunosenescence is a physiological part of aging linked to higher rates of diabetes, bacterial infections, and malignancies representing the major causes of death in older patients. These age-related changes impact older transplant candidates and may have significant implications for an age-adapted immunosuppression. For instance, immunosenescence is linked to lower rates of acute rejections in older recipients, whereas the engraftment of older organs has been associated with higher rejection rates. Moreover, new-onset diabetes mellitus after transplantation is more frequent in the elderly, potentially related to corticosteroids, calcineurin inhibitors, and mechanistic target of rapamycin inhibitors.This review presents current knowledge for an age-adapted immunosuppression based on both, experimental and clinical studies in and beyond transplantation. Recommendations of maintenance and induction therapy may help to improve graft function and to design future clinical trials in the elderly.

  4. Performance enhancement with supplements: incongruence between rationale and practice

    Directory of Open Access Journals (Sweden)

    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.

  5. Radiofrequency balloon angioplasty. Rationale and proof of principle

    Energy Technology Data Exchange (ETDEWEB)

    Becker, G.J.; Lee, B.I.; Waller, B.F.; Barry, K.J.; Kaplan, J.; Connolly, R.; Dreesen, R.G.; Nardella, P.

    1988-11-01

    Post-angioplasty restenosis (PARS) in atherosclerotic lesions of medium and small arteries occurs in about one-third of cases in the first year following percutaneous transluminal angioplasty (PTA) (early PARS). PARS includes acute spasm, dissection with reclosure, elastic recoil, fibrocellular proliferative response, and progressive atheromatous disease. Fibrocellular proliferation (possibly initiated by platelet derived growth factor) is felt to be culpable in many cases of early PARS (months). Pharmacologic regimens, stents, and thermal welding of the intimal-medial cracks of PTA are among the interventions being developed to deal with PARS. Radiofrequency (RF) current as a source of thermal energy may be useful in combination with balloon angioplasty to reduce PARS. Ideally, this combination would (1) weld intimal-medial cracks of PTA; (2) mold plaque and normal vessel to increase lumen diameters without creating intimal-medial cracks; and (3) destroy medial smooth muscle cells and multipotential cells (cellular substrate of PARS). Canine in vivo studies have established the feasibility of RF-mediated vascular tissue welding. Human aortic specimens (N = 28) were manually dissected into intima-media and media-adventitia layers. Bipolar RF energy (650 KHz, total 300 J) and mechanical pressure (1 atm) (experimental group, N = 24) or mechanical pressure alone (control group, N = 4) were applied to the reapposed specimen layers in a special chamber. The chamber was modified with a bipolar electrode designed to reproduce that planned for an RF balloon angioplasty catheter. Welding was demonstrated in normal and atherosclerotic treated specimens (23/24 or 96%) but not controls (0/4).

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

    Science.gov (United States)

    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.

  7. Midcarpal hemiarthroplasty for wrist arthritis: rationale and early results.

    Science.gov (United States)

    Vance, Michael C; Packer, Greg; Tan, David; Crisco, J J Trey; Wolfe, Scott W

    2012-08-01

    Midcarpal hemiarthroplasty is a novel motion-preserving treatment for radiocarpal arthritis and is an alternative to current procedures that provide pain relief at the expense of wrist biomechanics and natural motion. It is indicated primarily in active patients with a well-preserved distal row and debilitating arthritic symptoms. By resurfacing the proximal carpal row, midcarpal arthroplasty relieves pain while preserving the midcarpal articulation and the anatomic center of wrist rotation. This technique has theoretical advantages when compared with current treatment options (i.e., arthrodesis and total wrist arthroplasty) since it provides coupled wrist motion, preserves radial length, is technically simple, and avoids the inherent risks of nonunion and distal component failure. The KinematX midcarpal hemiarthroplasty has an anatomic design and does not disrupt the integrity of the wrist ligaments. We have implanted this prosthesis in nine patients with promising early results. The indications for surgery were as follows: scapholunate advanced collapse wrist (three), posttraumatic osteoarthritis (three), inflammatory arthritis (two), and Keinböck disease (one). Prospective data has been collected and the results are preliminary given the infancy of the procedure. The mean follow-up was 30.9 weeks (range: 16 to 56 weeks). The mean Mayo wrist score increased from 31.9 preoperatively to 58.8 (p manipulation for wrist stiffness. There was no evidence of prosthetic loosening or capitolunate narrowing. The procedure is simple (average surgical time was 49 minutes) and maintains coupled wrist motion through preservation of the midcarpal articulation. The preliminary data show that it appears safe but considerably longer follow-up is required before conclusions can be drawn as to its durability, reliability, and overall success. The level of evidence for this study is therapeutic level IV (case series).

  8. Rationale and design: telepsychology service delivery for depressed elderly veterans

    Directory of Open Access Journals (Sweden)

    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

  9. The Human Early-Life Exposome (HELIX): Project Rationale and Design

    Science.gov (United States)

    Slama, Rémy; Robinson, Oliver; Chatzi, Leda; Coen, Muireann; van den Hazel, Peter; Thomsen, Cathrine; Wright, John; Athersuch, Toby J.; Avellana, Narcis; Basagaña, Xavier; Brochot, Celine; Bucchini, Luca; Bustamante, Mariona; Carracedo, Angel; Casas, Maribel; Estivill, Xavier; Fairley, Lesley; van Gent, Diana; Gonzalez, Juan R.; Granum, Berit; Gražulevicˇiene˙, Regina; Gutzkow, Kristine B.; Julvez, Jordi; Keun, Hector C.; Kogevinas, Manolis; McEachan, Rosemary R.C.; Meltzer, Helle Margrete; Sabidó, Eduard; Schwarze, Per E.; Siroux, Valérie; Sunyer, Jordi; Want, Elizabeth J.; Zeman, Florence; Nieuwenhuijsen, Mark J.

    2014-01-01

    Background: Developmental periods in early life may be particularly vulnerable to impacts of environmental exposures. Human research on this topic has generally focused on single exposure–health effect relationships. The “exposome” concept encompasses the totality of exposures from conception onward, complementing the genome. Objectives: The Human Early-Life Exposome (HELIX) project is a new collaborative research project that aims to implement novel exposure assessment and biomarker methods to characterize early-life exposure to multiple environmental factors and associate these with omics biomarkers and child health outcomes, thus characterizing the “early-life exposome.” Here we describe the general design of the project. Methods: In six existing birth cohort studies in Europe, HELIX will estimate prenatal and postnatal exposure to a broad range of chemical and physical exposures. Exposure models will be developed for the full cohorts totaling 32,000 mother–child pairs, and biomarkers will be measured in a subset of 1,200 mother–child pairs. Nested repeat-sampling panel studies (n = 150) will collect data on biomarker variability, use smartphones to assess mobility and physical activity, and perform personal exposure monitoring. Omics techniques will determine molecular profiles (metabolome, proteome, transcriptome, epigenome) associated with exposures. Statistical methods for multiple exposures will provide exposure–response estimates for fetal and child growth, obesity, neurodevelopment, and respiratory outcomes. A health impact assessment exercise will evaluate risks and benefits of combined exposures. Conclusions: HELIX is one of the first attempts to describe the early-life exposome of European populations and unravel its relation to omics markers and health in childhood. As proof of concept, it will form an important first step toward the life-course exposome. Citation: Vrijheid M, Slama R, Robinson O, Chatzi L, Coen M, van den Hazel P

  10. A community based prevention of weight gain intervention (Mothers In Motion) among young low-income overweight and obese mothers: design and rationale

    OpenAIRE

    Chang, Mei-Wei; Nitzke, Susan; Brown, Roger; Resnicow, Ken

    2014-01-01

    Background Over 45% of American women 20–39 years old are at risk for type 2 diabetes, cardiovascular disease, and other health conditions because they are overweight or obese. The prevalence of overweight and obesity is disproportionately high among low-income women. This paper describes the study design and rationale of a community based intervention (Mothers In Motion, MIM) aimed to prevent weight gain among low-income overweight and obese mothers18-39 years old by promoting stress managem...

  11. USE OF REMICADE® IN PATIENTS WITH CHRONIC TOPHACEOUS GOUT: THEORETICAL RATIONALE AND ASSESSMENT OFOWN EXPERIENCE

    Directory of Open Access Journals (Sweden)

    M S Eliseyev

    2009-01-01

    Full Text Available The paper deals with the clinical experience in using Remicade®, a tumor necrosis factor-a (TNF-а inhibitor, in patients with chronic tophaceous gout resistant to therapy with glucocorticoids and nonsteroidal anti-inflammatory drugs. The agent is noted to have a good long-acting clinical effect in reducing the number of tender and swollen joints, as confirmed by the theoretical rationale for the use of anticytokine agents, TNF- а inhibitors in particular, in gouty patients.

  12. Enhancing measurement in science education research through Rasch analysis: Rationale and properties

    Directory of Open Access Journals (Sweden)

    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.

  13. [PCR rationale for use of oral cephalosporins by oral surgery procedures].

    Science.gov (United States)

    Tsarev, V N; Chuvilkin, V I; Akhmedov, G D; Chuvilkina, E I; Gadzhiev, F N; Nikitin, I V

    2014-01-01

    The article presents the experience of PCR detection of DNA of pathogenic germs inducing odontogenic inflammation. Pus samples of 48 patients aged 18 to 68 years undergoing oral surgery because of apical periodontal lesions and pericoronitis. The results showed microorganisms associations revealed by PCR are sensitive to III generation cephalosporins. Effective oral regimen included 400 mg Ceftibuten once daily. The PCR results thus served as a rationale for use of oral cephalosporins by oral surgery procedures proved by clinical and immunological data in postoperative period.

  14. Theoretical Rationale of Heating Block for Testing Bench of Aerospace Crafts Thermal Protection Elements

    Directory of Open Access Journals (Sweden)

    Petrova Anna A.

    2016-01-01

    Full Text Available 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.

  15. Pedagogical and didactical rationale of phonemic stimulation process in pre-school age children

    Directory of Open Access Journals (Sweden)

    López, Yudenia

    2010-01-01

    Full Text Available The paper describes the main results of a regional research problem dealing with education in pre-school age. It examines the effectiveness of the didactic conception of the process of phonemic stimulation in children from 3 to 5 years old. The pedagogical and didactic rationale of the process, viewed from the evolutionary, ontogeny, systemic perspective is explained. Likewise, possible scaffolding is illustrated. The suggested procedures focus the provision of support on a systematic and purposely practice which involve first the discrimination of non-verbal sounds and the discrimi-nation of verbal sound later, aiming to the creation of a phonological consciousness.

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

    Directory of Open Access Journals (Sweden)

    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.

  17. Examining reports and policies on cognitive enhancement: approaches, rationale, and recommendations.

    Science.gov (United States)

    Outram, Simon M; Racine, Eric

    2011-01-01

    The phenomenon of cognitive enhancement is attracting attention in bioethics literature and beyond, in public policy. In response, three bodies--the British Medical Association (BMA); the Commission de l'éthique de la Science et de la technologie (CEST) du Québec; the American Academy of Neurology (AAN)--have produced reports and guidance on this topic. To gain insights into different public policy approaches, rationales, and recommendations on the topic, we analyzed these reports in depth. We found convergence on the definition (with the exception of the CEST) of cognitive enhancement. However, we noted a lack of critical reflection with respect to the underlying rationale for developing these reports, i.e., that cognitive enhancement practices are rampant and represent major social changes. As it currently stands, cognitive enhancement is constituted in a way that challenges the creation of coherent and effective policy recommendations. However, policy makers should not simply wait for definitional consensus and hope that on balance the benefits turn out to be greater than the risks. Some components of cognitive enhancement could be reduced down to clearly identified policy targets to be further examined. Then, if appropriate, policy should be created that is, amongst other criteria, beneficial to the majority of the population.

  18. History, rationale, and lessons learned: Thresholds of potential concern in Kruger National Park river adaptive management

    Directory of Open Access Journals (Sweden)

    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.

  19. 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

    OpenAIRE

    Post, Janisse M.; Ali, Shozab S.; Roberson, Lara L; Aneni, Ehimen C.; Shaharyar, Sameer; Younus, Adnan; Jamal, Omar; Ahmad, Rameez; Aziz, Muhammad; Malik, Rehan; Spatz, Erica S.; Feldman, Theodore; Fialkow, Jonathan; Veledar, Emir; Cury, Ricardo C.

    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 availab...

  20. 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

    OpenAIRE

    Post, Janisse M.; Ali, Shozab S.; Roberson, Lara L; Aneni, Ehimen C.; Shaharyar, Sameer; Younus, Adnan; Jamal, Omar; Ahmad, Rameez; Aziz, Muhammad A.; Malik, Rehan; Spatz, Erica S.; Feldman, Theodore; Fialkow, Jonathan; Veledar, Emir; Cury, Ricardo C.

    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...

  1. Economic and Risk Analyses for SMEs Internationalization Projects. A Preliminary Insight on the Rationale of Business Consulting Firms

    Directory of Open Access Journals (Sweden)

    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.

  2. Mechanistic Rationale to Target PTEN-Deficient Tumor Cells with Inhibitors of the DNA Damage Response Kinase ATM.

    Science.gov (United States)

    McCabe, Nuala; Hanna, Conor; Walker, Steven M; Gonda, David; Li, Jie; Wikstrom, Katarina; Savage, Kienan I; Butterworth, Karl T; Chen, Clark; Harkin, D Paul; Prise, Kevin M; Kennedy, Richard D

    2015-06-01

    Ataxia telangiectasia mutated (ATM) is an important signaling molecule in the DNA damage response (DDR). ATM loss of function can produce a synthetic lethal phenotype in combination with tumor-associated mutations in FA/BRCA pathway components. In this study, we took an siRNA screening strategy to identify other tumor suppressors that, when inhibited, similarly sensitized cells to ATM inhibition. In this manner, we determined that PTEN and ATM were synthetically lethal when jointly inhibited. PTEN-deficient cells exhibited elevated levels of reactive oxygen species, increased endogenous DNA damage, and constitutive ATM activation. ATM inhibition caused catastrophic DNA damage, mitotic cell cycle arrest, and apoptosis specifically in PTEN-deficient cells in comparison with wild-type cells. Antioxidants abrogated the increase in DNA damage and ATM activation in PTEN-deficient cells, suggesting a requirement for oxidative DNA damage in the mechanism of cell death. Lastly, the ATM inhibitor KU-60019 was specifically toxic to PTEN mutant cancer cells in tumor xenografts and reversible by reintroduction of wild-type PTEN. Together, our results offer a mechanistic rationale for clinical evaluation of ATM inhibitors in PTEN-deficient tumors.

  3. Healthy eating for life: rationale and development of an English as a second language (ESL) curriculum for promoting healthy nutrition.

    Science.gov (United States)

    Martinez, Josefa L; Rivers, Susan E; Duncan, Lindsay R; Bertoli, Michelle; Domingo, Samantha; Latimer-Cheung, Amy E; Salovey, Peter

    2013-12-01

    Low health literacy contributes significantly to cancer health disparities disadvantaging minorities and the medically underserved. Immigrants to the United States constitute a particularly vulnerable subgroup of the medically underserved, and because many are non-native English speakers, they are pre-disposed to encounter language and literacy barriers across the cancer continuum. Healthy Eating for Life (HE4L) is an English as a second language (ESL) curriculum designed to teach English language and health literacy while promoting fruit and vegetable consumption for cancer prevention. This article describes the rationale, design, and content of HE4L. HE4L is a content-based adult ESL curriculum grounded in the health action process approach to behavior change. The curriculum package includes a soap opera-like storyline, an interactive student workbook, a teacher's manual, and audio files. HE4L is the first teacher-administered, multimedia nutrition-education curriculum designed to reduce cancer risk among beginning-level ESL students. HE4L is unique because it combines adult ESL principles, health education content, and behavioral theory. HE4L provides a case study of how evidence-based, health promotion practices can be implemented into real-life settings and serves as a timely, useful, and accessible nutrition-education resource for health educators.

  4. 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)

    Energy Technology Data Exchange (ETDEWEB)

    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.

  5. 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

    Directory of Open Access Journals (Sweden)

    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

  6. 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

    Science.gov (United States)

    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

  7. 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.

    Science.gov (United States)

    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-year U.S.-wide randomized, double-blind, placebo-controlled, 2 × 2 factorial trial of supplementation with vitamin D3 ([cholecalciferol], 2000 IU/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.

  8. A novel approach to treatment of hypertension in diabetic patients - a multicenter, double-blind, randomized study comparing the efficacy of combination therapy of Eprosartan versus Ramipril with low-dose Hydrochlorothiazide and Moxonidine on blood pressure levels in patients with hypertension and associated diabetes mellitus type 2 - rationale and design [ISRCTN55725285].

    Science.gov (United States)

    Pater, Cornel; Bhatnagar, Deepak; Berrou, Jean-Pascal; Luszick, Joachim; Beckmann, Katrin

    2004-10-01

    Hypertension and diabetes mellitus are closely interrelated and coexist in as many as two-thirds of patients with type 2 diabetes. The consequent risk of such an association is an accelerated development of atherosclerotic cardiovascular disease and nephropathy complications.In choosing an antihypertensive agent, effectiveness needs to be accompanied by favourable metabolic, cardioprotective, and nephroprotective properties. Given the multifactorial nature of hypertension, the approach that has gained widespread agreement is treatment with more than one agent. Agents with different mechanisms of action increase antihypertensive efficacy because of synergistic impacts on the cardiovascular system. Combination therapy allows the use of lower doses of each antihypertensive agent which accounts for the excellent tolerability of combination products.The aim of the present study is to quantify the efficacy of combination therapy of Eprosartan 600 mg respectively Ramipril 5 mg with low-dose Hydrochlorothiazide and Moxonidine on blood pressure levels in patients with essential hypertension and associated diabetes mellitus type 2.The use of monotherapy (Eprosartan or Ramipril) followed by addition of low-dose Hydrochlorothiazide as second agent and of Moxonidine as a third agent will be individualized to the severity of hypertension in the particular patient and to his/her degree of response to current treatment.

  9. A novel approach to treatment of hypertension in diabetic patients – a multicenter, double-blind, randomized study comparing the efficacy of combination therapy of Eprosartan versus Ramipril with low-dose Hydrochlorothiazide and Moxonidine on blood pressure levels in patients with hypertension and associated diabetes mellitus type 2 – rationale and design [ISRCTN55725285

    Directory of Open Access Journals (Sweden)

    Luszick Joachim

    2004-10-01

    Full Text Available Abstract Hypertension and diabetes mellitus are closely interrelated and coexist in as many as two-thirds of patients with type 2 diabetes. The consequent risk of such an association is an accelerated development of atherosclerotic cardiovascular disease and nephropathy complications. In choosing an antihypertensive agent, effectiveness needs to be accompanied by favourable metabolic, cardioprotective, and nephroprotective properties. Given the multifactorial nature of hypertension, the approach that has gained widespread agreement is treatment with more than one agent. Agents with different mechanisms of action increase antihypertensive efficacy because of synergistic impacts on the cardiovascular system. Combination therapy allows the use of lower doses of each antihypertensive agent which accounts for the excellent tolerability of combination products. The aim of the present study is to quantify the efficacy of combination therapy of Eprosartan 600 mg respectively Ramipril 5 mg with low-dose Hydrochlorothiazide and Moxonidine on blood pressure levels in patients with essential hypertension and associated diabetes mellitus type 2. The use of monotherapy (Eprosartan or Ramipril followed by addition of low-dose Hydrochlorothiazide as second agent and of Moxonidine as a third agent will be individualized to the severity of hypertension in the particular patient and to his/her degree of response to current treatment.

  10. A novel approach to treatment of hypertension in diabetic patients – a multicenter, double-blind, randomized study comparing the efficacy of combination therapy of Eprosartan versus Ramipril with low-dose Hydrochlorothiazide and Moxonidine on blood pressure levels in patients with hypertension and associated diabetes mellitus type 2 – rationale and design [ISRCTN55725285

    Science.gov (United States)

    Pater, Cornel; Bhatnagar, Deepak; Berrou, Jean-Pascal; Luszick, Joachim; Beckmann, Katrin

    2004-01-01

    Hypertension and diabetes mellitus are closely interrelated and coexist in as many as two-thirds of patients with type 2 diabetes. The consequent risk of such an association is an accelerated development of atherosclerotic cardiovascular disease and nephropathy complications. In choosing an antihypertensive agent, effectiveness needs to be accompanied by favourable metabolic, cardioprotective, and nephroprotective properties. Given the multifactorial nature of hypertension, the approach that has gained widespread agreement is treatment with more than one agent. Agents with different mechanisms of action increase antihypertensive efficacy because of synergistic impacts on the cardiovascular system. Combination therapy allows the use of lower doses of each antihypertensive agent which accounts for the excellent tolerability of combination products. The aim of the present study is to quantify the efficacy of combination therapy of Eprosartan 600 mg respectively Ramipril 5 mg with low-dose Hydrochlorothiazide and Moxonidine on blood pressure levels in patients with essential hypertension and associated diabetes mellitus type 2. The use of monotherapy (Eprosartan or Ramipril) followed by addition of low-dose Hydrochlorothiazide as second agent and of Moxonidine as a third agent will be individualized to the severity of hypertension in the particular patient and to his/her degree of response to current treatment. PMID:15461784

  11. Introduction of a prognostic biomarker to strengthen risk stratification of acutely admitted patients: rationale and design of the TRIAGE III cluster randomized interventional trial

    DEFF Research Database (Denmark)

    Sandø, Andreas; Schultz, Martin; Eugen-Olsen, Jesper

    2016-01-01

    patients at the ED. The main hypothesis is that the availability of suPAR can reduce all-cause mortality, assessed at least 10 months after admission, by drawing attention towards patients with an unrecognized high risk, leading to improved diagnostics and treatment. METHODS: The study is designed...... as a cross-over cluster randomized interventional trial. SuPAR is measured within 2 h after admission and immediately reported to the treating physicians in the ED. All ED physicians are educated in the prognostic capabilities of suPAR prior to the inclusion period. The inclusion period began January 11(th......) 2016 and ends June 6(th) 2016. The study aims to include 10.000 patients in both the interventional and control arm. The results will be presented in 2017. DISCUSSION: The present article aims to describe the design and rationale of the TRIAGE III study that will investigate whether the availability...

  12. Utilization management in radiology, part 1: rationale, history, and current status.

    Science.gov (United States)

    Duszak, Richard; Berlin, Jonathan W

    2012-10-01

    Previous growth in the utilization of medical imaging has led to numerous efforts to reduce associated spending. Although these have historically been directed toward unit cost reductions, recent interest has emerged by various stakeholders in curbing inappropriate utilization. Radiology benefits managers have widespread market penetration and have been promoted largely by the payer community as effective mechanisms to curb increases in imaging volume. The provider community has tended to favor real-time order entry decision support systems. These have demonstrated comparable effectiveness to radiology benefits managers in early projects but currently have only limited market penetration. In this first of a two-part series, the rationale for the development of utilization management programs will be discussed and their history and current status reviewed.

  13. Tyler’s Curriculum Rationale and the Reconceptualists. Interview with Ralph W. Tyler (1902-1994

    Directory of Open Access Journals (Sweden)

    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.

  14. The CfAO's Astronomy Course in COSMOS: Curriculum Design, Rationale, and Application

    CERN Document Server

    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.

  15. Rationale for the use of multifunctional drugs as neuroprotective agents for glaucoma

    Institute of Scientific and Technical Information of China (English)

    Jiahua Fang; Fagang Jiang; Jingbo Li; Yanhua Zhu

    2012-01-01

    Glaucoma, the leading cause globally of irreversible blindness, is a neurodegenerative disease characterized by progressive retinal ganglion cell death. To date, no drug has been shown to prevent the retinal ganglion cell loss associated with glaucoma. Multiple mechanisms lead to ganglion cell death in glaucoma, suggesting that a neuroprotectant that has a single mode of action, like memantine, would have a limited positive effect at slowing down ganglion cell death. Conversely, simultaneously targeting several factors may be the best therapeutic approach to improve outcomes. Multifunctional drugs are fast gaining acceptance as a strategy for the treatment of complex disor-ders of the central nervous system, such as Parkinson's disease, Alzheimer's disease and other progressive neurodegenerative diseases. In this paper, we review the current literature on multi-functional drugs and propose a rationale for the use of multifunctional drugs in glaucomatous optic neuropathy.

  16. Rationale for the Design of a Web-based Programming Course for Adults

    DEFF Research Database (Denmark)

    Bennedsen, Jens; Caspersen, Michael Edelgaard

    2003-01-01

    Web-based distance education is becoming more and more popular in particular for part-time educations primarily because it flexibly adapts to a busy life where family and work has first priority. Students can follow the course without wasting precious time traveling to and from campus several...... evenings a week, and participation can take place also in situations where it would otherwise be impossible (e.g. a sick child or a business trip). However, these advantages don't come for free: the students lose the social relations following from face-to-face contact with the lecturer and teaching...... 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...

  17. Rationale and benefits of trimetazidine by acting on cardiac metabolism in heart failure.

    Science.gov (United States)

    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.

  18. Brainstem Monitoring in the Neurocritical Care Unit: A Rationale for Real-Time, Automated Neurophysiological Monitoring.

    Science.gov (United States)

    Stone, James L; Bailes, Julian E; Hassan, Ahmed N; Sindelar, Brian; Patel, Vimal; Fino, John

    2017-02-01

    Patients with severe traumatic brain injury or large intracranial space-occupying lesions (spontaneous cerebral hemorrhage, infarction, or tumor) commonly present to the neurocritical care unit with an altered mental status. Many experience progressive stupor and coma from mass effects and transtentorial brain herniation compromising the ascending arousal (reticular activating) system. Yet, little progress has been made in the practicality of bedside, noninvasive, real-time, automated, neurophysiological brainstem, or cerebral hemispheric monitoring. In this critical review, we discuss the ascending arousal system, brain herniation, and shortcomings of our current management including the neurological exam, intracranial pressure monitoring, and neuroimaging. We present a rationale for the development of nurse-friendly-continuous, automated, and alarmed-evoked potential monitoring, based upon the clinical and experimental literature, advances in the prognostication of cerebral anoxia, and intraoperative neurophysiological monitoring.

  19. Searching for economic rationale behind gated communities: a public choice approach.

    Science.gov (United States)

    Cséfalvay, Zoltán

    2011-01-01

    As millions of people world-wide now live in residential areas with restricted access to the public, the ascent of gated communities can no longer be attributed to incidental or deviant development. Hence this paper makes an attempt to discover the economic rationale behind the gated community phenomenon; it discusses the mainstream theses and outlines 10 theorems for an alternative proposition based on theories of public choice and fiscal federalism. The core theorem asserts that a centrally featured system of government diminishes the ability of local municipalities properly to reflect citizens' demands for local public goods and services, and that this constitutes a strong incentive for people to move into gated communities. In particular, gated and guarded residential developments represent an exit option when local municipalities fail to deploy vital governmental rules and instruments, such as fiscal equivalence and benefit taxation.

  20. The anti-interleukin-1 in type 1 diabetes action trial--background and rationale

    DEFF Research Database (Denmark)

    Pickersgill, Linda M S; Mandrup-Poulsen, Thomas R

    2009-01-01

    Type 1 diabetes (T1D) is caused by an inflammatory destruction of pancreatic beta-cells. Pro-inflammatory cytokines, in particular interleukin-1 (IL-1), have been suggested to be effector molecules based on the observations that pro-inflammatory cytokines cause beta-cell apoptosis in vitro...... and aggravate diabetes in vivo, and that inhibition of the action of these cytokines reduce diabetes incidence in animal models of type 1 diabetes and islet graft destruction. This review presents the rationale for and design of a recently launched double-blind, multicenter, randomized clinical trial...... that investigates the effect of interleukin-1 antagonism on beta-cell function in subjects with T1D of recent-onset....

  1. Why Telestroke networks? Rationale, implementation and results of the Stroke Eastern Saxony Network.

    Science.gov (United States)

    Bodechtel, Ulf; Puetz, Volker

    2013-09-01

    Stroke is the third leading cause of death and the leading cause of acquired long-term disability in Europe and North America. Intravenous (IV) thrombolysis with alteplase and organized inpatient (stroke unit) care have been shown to improve stroke patients' functional outcomes. However, stroke unit care is not area-wide available and thrombolysis rates are low, partly due to limited stroke thrombolysis expertise in smaller community hospitals. Telemedical stroke networks (Telestroke network) with remote video assessment of patients and brain computed tomography (CT) scans by stroke neurologists have been shown to increase IV thrombolysis rates and functional outcomes of patients in smaller community hospitals. Our article summarizes the rationale, clinical, and currently published scientific results of Telestroke networks with special respect to the telemedical Stroke Eastern Saxony Network (SOS-NET), which has been established by the Dresden University Stroke Center (DUSC) in July 2007. From July 2007 to December 2012, 3416 teleconsultations have been performed within the SOS-NET.

  2. Resolution of bilateral moyamoya associated collateral vessel aneurysms: Rationale for endovascular versus surgical intervention

    Directory of Open Access Journals (Sweden)

    Sepideh Amin-Hanjani

    2014-01-01

    Full Text Available Background: Management of aneurysms associated with deep collateral vessels in moyamoya disease is challenging both from an endovascular and a surgical standpoint. Difficulties with access or localization, and compromise of the collateral circulation with subsequent ischemia are the primary concerns, making direct obliteration potentially unfeasible or risky. Alternatively, superficial temporal artery-middle cerebral artery bypass is another potential strategy for resolution of these aneurysms. Case Description: Presented are the findings and management for a patient with moyamoya disease and bilateral deep collateral vessel aneurysms, successfully treated with endovascular obliteration following a right-sided hemorrhage and subsequently with bypass for an unruptured but growing contralateral aneurysm. Conclusions: A rationale and approach to management is outlined, as derived from review of the current literature and the illustrative case with bilateral collateral vessel aneurysms.

  3. The role of Amazonian anthropogenic soils in shifting cultivation: learning from farmers' rationales

    Directory of Open Access Journals (Sweden)

    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

  4. Study rationale and design of the CIMT trial: the Copenhagen Insulin and Metformin Therapy trial

    DEFF Research Database (Denmark)

    Lundby Christensen, L; Almdal, T; Boesgaard, T

    2009-01-01

    in 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......-acting insulin analogue. RANDOMIZATION: Central randomization stratified for age (above 65 years), previous insulin treatment and treatment centre. INTERVENTIONS: Metformin 1 g x two times daily vs. placebo (approximately 475 patients vs. 475 patients) in combination with insulin detemir before bedtime...

  5. Internationalization Rationales, Obstacles and Drivers: A Multiple Case Study of Spanish Higher Education Institutions

    Science.gov (United States)

    Grasset, Cristina

    2013-01-01

    This research examined the cases of three diverse Spanish universities, making inferences about the factors influencing the internationalization processes of higher education institutions in response to the broader forces of globalization. Data were collected from a panel of experts and multiple public and institutional sources utilizing a mixed…

  6. Paediatric European Risperidone Studies (PERS) : context, rationale, objectives, strategy, and challenges

    NARCIS (Netherlands)

    Glennon, Jeffrey; Purper-Ouakil, Diane; Bakker, Mireille; Zuddas, Alessandro; Hoekstra, Pieter; Schulze, Ulrike; Castro-Fornieles, Josefina; Santosh, Paramala J.; Arango, Celso; Koelch, Michael; Coghill, David; Flamarique, Itziar; Penzol, Maria J.; Wan, Mandy; Murray, Macey; Wong, Ian C. K.; Danckaerts, Marina; Bonnot, Olivier; Falissard, Bruno; Masi, Gabriele; Fegart, Joerg M.; Vicari, Stefano; Carucci, Sara; Dittmann, Ralf W.; Buitelaar, Jan K.

    2014-01-01

    In children and adolescents with conduct disorder (CD), pharmacotherapy is considered when non-pharmacological interventions do not improve symptoms and functional impairment. Risperidone, a second-generation antipsychotic is increasingly prescribed off-label in this indication, but its efficacy and

  7. Neuroimaging Studies of Factors Related to Exercise: Rationale and design of a 9 month trial

    OpenAIRE

    Herrmann, Stephen D.; Martin, Laura E.; Breslin, Florence J.; Jeffery J Honas; 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...

  8. The Tianjin Mental Health Survey (TJMHS) : study rationale, design and methods

    NARCIS (Netherlands)

    Yin, Huifang; Phillips, Michael R; Wardenaar, Klaas J; Xu, Guangming; Ormel, Johan; Tian, Hongjun; Schoevers, Robert A

    2016-01-01

    Mental health in China is of growing concern to both policy-makers and researchers. The Tianjin Mental Health Survey (TJMHS) was conducted between July 2011 and March 2012 to assess the prevalence and risk factors of mental disorders in the context of recent economic growth and other socio-demograph

  9. Maximum recovery after knee replacement – the MARKER study rationale and protocol

    Directory of Open Access Journals (Sweden)

    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

  10. Rationale and design of the Measuring Athlete's Risk of Cardiovascular events (MARC) study

    NARCIS (Netherlands)

    Braber, T. L.; Mosterd, A.; Prakken, N. H. J.; Doevendans, P. A. F. M.; Mali, W. P. Th. M.; Backx, F. J. G.; Grobbee, D. E.; Rienks, R.; Nathoe, H. M.; Bots, M. L.; Velthuis, B. K.

    2015-01-01

    Background More than 90 % of exercise-related cardiac arrests occur in men, predominantly those aged 45 years and older with coronary artery disease (CAD) as the main cause. The current sports medical evaluation (SME) of middle-aged recreational athletes consists of a medical history, physical exami

  11. The Biomarkers of Exposure and Effect in Agriculture (BEEA) Study: Rationale, design, methods, and participant characteristics

    Science.gov (United States)

    Agricultural exposures including pesticides, endotoxin, and allergens have been associated with risk of various cancers and other chronic diseases, although the biological mechanisms underlying these associations are generally unclear. To facilitate future molecular epidemiologic...

  12. Listening to Audiences: A Brief Rationale and History of Audience Research in Popular Media Studies

    Science.gov (United States)

    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…

  13. Subsidizing Early Childhood Education and Care for Parents on Low Income: Moving beyond the Individualized Economic Rationale of Neoliberalism

    Science.gov (United States)

    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…

  14. The Rationale for Subsidy of Higher Education in Hong Kong: A Sensible Decision from an Economic Viewpoint

    Science.gov (United States)

    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…

  15. A randomized controlled trial to evaluate self-determination theory for exercise adherence and weight control: rationale and intervention description

    Directory of Open Access Journals (Sweden)

    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

  16. A randomised controlled trial of the efficacy of the ABCD Parenting Young Adolescents Program: rationale and methodology

    Directory of Open Access Journals (Sweden)

    Burke Kylie

    2010-08-01

    Full Text Available Abstract Background The transition to adolescence is a time of increased vulnerability for risk taking and poor health, social and academic outcomes. Parents have an important role in protecting their children from these potential harms. While the effectiveness of parenting programs in reducing problem behavior has been demonstrated, it is not known if parenting programs that target families prior to the onset of significant behavioral difficulties in early adolescence (9-14 years improve the wellbeing of adolescents and their parents. This paper describes the rationale and methodology of a randomised controlled trial testing the efficacy of a parenting program for the promotion of factors known to be associated with positive adolescent outcomes, such as positive parenting practices, parent-adolescent relationships and adolescent behavior. Methods/Design One hundred and eighty parents were randomly allocated to an intervention or wait list control group. Parents in the intervention group participated in the ABCD Parenting Young Adolescents Program, a 6-session behavioral family intervention program which also incorporates acceptance-based strategies. Participants in the Wait List control group did not receive the intervention during a six month waiting period. The study was designed to comply with recommendations of the CONSORT statement. The primary outcome measures were reduction in parent-adolescent conflict and improvements in parent-adolescent relationships. Secondary outcomes included improvements in parent psychosocial wellbeing, parenting self-efficacy and perceived effectiveness, parent-adolescent communication and adolescent behavior. Conclusions Despite the effectiveness of parenting programs in reducing child behavioral difficulties, very few parenting programs for preventing problems in adolescents have been described in the peer reviewed literature. This study will provide data which can be used to examine the efficacy of a

  17. Oral Contraceptive Pills: Combinations, Dosages and the Rationale behind 50 Years or Oral Hormonal Contraceptive Development

    Directory of Open Access Journals (Sweden)

    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

  18. Is there a rationale for pulmonary rehabilitation following successful chemotherapy for tuberculosis?

    Science.gov (United States)

    Muñoz-Torrico, Marcela; Rendon, Adrian; Centis, Rosella; D'Ambrosio, Lia; Fuentes, Zhenia; Torres-Duque, Carlos; Mello, Fernanda; Dalcolmo, Margareth; Pérez-Padilla, Rogelio; Spanevello, Antonio; Migliori, Giovanni Battista

    2016-01-01

    The role of tuberculosis as a public health care priority and the availability of diagnostic tools to evaluate functional status (spirometry, plethysmography, and DLCO determination), arterial blood gases, capacity to perform exercise, lesions (chest X-ray and CT), and quality of life justify the effort to consider what needs to be done when patients have completed their treatment. To our knowledge, no review has ever evaluated this topic in a comprehensive manner. Our objective was to review the available evidence on this topic and draw conclusions regarding the future role of the "post-tuberculosis treatment" phase, which will potentially affect several million cases every year. We carried out a non-systematic literature review based on a PubMed search using specific keywords (various combinations of the terms "tuberculosis", "rehabilitation", "multidrug-resistant tuberculosis", "pulmonary disease", "obstructive lung disease", and "lung volume measurements"). The reference lists of the most important studies were retrieved in order to improve the sensitivity of the search. Manuscripts written in English, Spanish, and Russian were selected. The main areas of interest were tuberculosis sequelae following tuberculosis diagnosis and treatment; "destroyed lung"; functional evaluation of sequelae; pulmonary rehabilitation interventions (physiotherapy, long-term oxygen therapy, and ventilation); and multidrug-resistant tuberculosis.The evidence found suggests that tuberculosis is definitively responsible for functional sequelae, primarily causing an obstructive pattern on spirometry (but also restrictive and mixed patterns), and that there is a rationale for pulmonary rehabilitation. We also provide a list of variables that should be discussed in future studies on pulmonary rehabilitation in patients with post-tuberculosis sequelae. RESUMO O papel da tuberculose como uma prioridade de saúde pública e a disponibilidade de ferramentas diagnósticas para avaliar o estado

  19. The Family Spirit trial for American Indian teen mothers and their children: CBPR rationale, design, methods and baseline characteristics.

    Science.gov (United States)

    Mullany, Britta; Barlow, Allison; Neault, Nicole; Billy, Trudy; Jones, Tanya; Tortice, Iralene; Lorenzo, Sherilynn; Powers, Julia; Lake, Kristin; Reid, Raymond; Walkup, John

    2012-10-01

    The purpose of this paper is to describe the rationale, design, methods and baseline results of the Family Spirit trial. The goal of the trial is to evaluate the impact of the paraprofessional-delivered "Family Spirit" home-visiting intervention to reduce health and behavioral risks for American Indian teen mothers and their children. A community based participatory research (CBPR) process shaped the design of the current randomized controlled trial of the Family Spirit intervention. Between 2006 and 2008, 322 pregnant teens were randomized to receive the Family Spirit intervention plus Optimized Standard Care, or Optimized Standard Care alone. The Family Spirit intervention is a 43-session home-visiting curriculum administered by American Indian paraprofessionals to teen mothers from 28 weeks gestation until the baby's third birthday. A mixed methods assessment administered at nine intervals measures intervention impact on parental competence, mother's and children's social, emotional and behavioral risks for drug use, and maladaptive functioning. Participants are young (mean age = 18.1 years), predominantly primiparous, unmarried, and challenged by poverty, residential instability and low educational attainment. Lifetime and pregnancy drug use were ~2-4 times higher and ~5-6 times higher, respectively, than US All Races. Baseline characteristics were evenly distributed between groups, except for higher lifetime cigarette use and depressive symptoms among intervention mothers. If study aims are achieved, the public health field will have new evidence supporting multi-generational prevention of behavioral health disparities affecting young American Indian families and the utility of indigenous paraprofessional interventionists in under-resourced communities.

  20. Taking the Blood Bank to the Field: The Design and Rationale of the Prehospital Air Medical Plasma (PAMPer) Trial.

    Science.gov (United States)

    Brown, Joshua B; Guyette, Francis X; Neal, Matthew D; Claridge, Jeffrey A; Daley, Brian J; Harbrecht, Brian G; Miller, Richard S; Phelan, Herb A; Adams, Peter W; Early, Barbara J; Peitzman, Andrew B; Billiar, Timothy R; Sperry, Jason L

    2015-01-01

    Hemorrhage and trauma induced coagulopathy remain major drivers of early preventable mortality in military and civilian trauma. Interest in the use of prehospital plasma in hemorrhaging patients as a primary resuscitation agent has grown recently. Trauma center-based damage control resuscitation using early and aggressive plasma transfusion has consistently demonstrated improved outcomes in hemorrhaging patients. Additionally, plasma has been shown to have several favorable immunomodulatory effects. Preliminary evidence with prehospital plasma transfusion has demonstrated feasibility and improved short-term outcomes. Applying state-of-the-art resuscitation strategies to the civilian prehospital arena is compelling. We describe here the rationale, design, and challenges of the Prehospital Air Medical Plasma (PAMPer) trial. The primary objective is to determine the effect of prehospital plasma transfusion during air medical transport on 30-day mortality in patients at risk for traumatic hemorrhage. This study is a multicenter cluster randomized clinical trial. The trial will enroll trauma patients with profound hypotension (SBP ≤ 70 mmHg) or hypotension (SBP 71-90 mmHg) and tachycardia (HR ≥ 108 bpm) from six level I trauma center air medical transport programs. The trial will also explore the effects of prehospital plasma transfusion on the coagulation and inflammatory response following injury. The trial will be conducted under exception for informed consent for emergency research with an investigational new drug approval from the U.S. Food and Drug Administration utilizing a multipronged community consultation process. It is one of three ongoing Department of Defense-funded trials aimed at expanding our understanding of the optimal therapeutic approaches to coagulopathy in the hemorrhaging trauma patient.

  1. The Danish Alzheimer intervention study

    DEFF Research Database (Denmark)

    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...

  2. A randomized controlled trial investigation of a non-stimulant in attention deficit hyperactivity disorder (ACTION: Rationale and design

    Directory of Open Access Journals (Sweden)

    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

  3. Analysis and evaluation of the rationales for single-sex schooling.

    Science.gov (United States)

    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.

  4. Inpatients' attitudes towards the rationale use of drugs at a cardiology ward

    Directory of Open Access Journals (Sweden)

    Ugur Ugrak

    2015-04-01

    Full Text Available AIM: This descriptive survey purposed to evaluate inpatients' attitudes towards the rationale use of drugs at a cardiology ward in GATA. METHODS: Rational Drug Use Questionnaire designed by T.C. Health Ministry was performed. The patients hospitalized during the research period were tried to be reached and 121 inpatients completed the questionnaire. SPSS 15.0 program was used for data evaluation. Descriptive statistics were indicated with mean, standard deviation, frequency. Pearsons Chi-Square Test was used for comparison of groups. Statistical significance at p<0.05 was adopted. RESULTS: Mean age of patient surveyed was 29.3+/-16.4 year and 68.6% of the patients were male. It was seen that 49.6% of the patients reserved residual drugs of a treatment at home to reuse, 87.6% of the patients applied to a physician when drug side effect was seen. 42.1% of female and 36.2% of married participants were seen to use painkiller without prescription. Additionally, significant relationship was observed between attitude of using painkiller without prescription and gender, marital status. CONCLUSION: Our research participants' attitudes towards rational drug use found more positive than previous researches performed in Turkey. It is assessed this difference resulted from participant's high education level and participants' obligation to use drugs for long time because most of them had chronic or congenital heart disease. [TAF Prev Med Bull 2015; 14(2.000: 137-144

  5. In utero stem cell transplantation and gene therapy: rationale, history, and recent advances toward clinical application.

    Science.gov (United States)

    Almeida-Porada, Graça; Atala, Anthony; Porada, Christopher D

    2016-01-01

    Recent advances in high-throughput molecular testing have made it possible to diagnose most genetic disorders relatively early in gestation with minimal risk to the fetus. These advances should soon allow widespread prenatal screening for the majority of human genetic diseases, opening the door to the possibility of treatment/correction prior to birth. In addition to the obvious psychological and financial benefits of curing a disease in utero, and thereby enabling the birth of a healthy infant, there are multiple biological advantages unique to fetal development, which provide compelling rationale for performing potentially curative treatments, such as stem cell transplantation or gene therapy, prior to birth. Herein, we briefly review the fields of in utero transplantation (IUTx) and in utero gene therapy and discuss the biological hurdles that have thus far restricted success of IUTx to patients with immunodeficiencies. We then highlight several recent experimental breakthroughs in immunology, hematopoietic/marrow ontogeny, and in utero cell delivery, which have collectively provided means of overcoming these barriers, thus setting the stage for clinical application of these highly promising therapies in the near future.

  6. Holonic Rationale and Bio-inspiration on Design of Complex Emergent and Evolvable Systems

    Science.gov (United States)

    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.

  7. The rationale for simple approaches for sustainability assessment and management in contaminated land practice.

    Science.gov (United States)

    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.

  8. Prolonging β-lactam infusion: a review of the rationale and evidence, and guidance for implementation.

    Science.gov (United States)

    MacVane, Shawn H; Kuti, Joseph L; Nicolau, David P

    2014-02-01

    Given the sparse antibiotic pipeline and the increasing prevalence of resistant organisms, efforts should be made to optimise the pharmacodynamic exposure of currently available agents. Prolonging the infusion duration is a strategy used to increase the percentage of the dosing interval that free drug concentrations remain above the minimum inhibitory concentration (fT>MIC), the pharmacodynamic efficacy driver for time-dependent antibiotics such as β-lactams. β-Lactams, the most commonly prescribed class of antibiotics owing to their efficacy and safety profile, have been the mainstay of therapy since the discovery of penicillin over 60 years ago. Mounting evidence, including the use of population pharmacokinetic modelling and Monte Carlo simulation, suggests that prolonging the infusion time of β-lactam antibiotics may have advantages over standard infusion techniques, including an enhanced probability of achieving requisite fT>MIC exposures, lower mortality and potentially reductions in infection/antibiotic-related costs. As a result of these favourable attributes, clinical practice guidelines support the use of prolonged-infusion β-lactams in the treatment of many severe infections. This article discusses the rationale and evidence for prolonging the infusion of β-lactam antibiotics and provides guidance for the implementation of a prolonged-infusion programme.

  9. Spinal shock and brain death': somatic pathophysiological equivalence and implications for the integrative-unity rationale.

    Science.gov (United States)

    Shewmon, D A

    1999-05-01

    The somatic pathophysiology of high spinal cord injury (SCI) not only is of interest in itself but also sheds light on one of the several rationales proposed for equating 'brain death' (BD) with death, namely that the brain confers integrative unity upon the body, which would otherwise constitute a mere conglomeration of cells and tissues. Insofar as the neuropathology of BD includes infarction down to the foramen magnum, the somatic pathophysiology of BD should resemble that of cervico-medullary junction transection plus vagotomy. The endocrinologic aspects can be made comparable either by focusing on BD patients without diabetes insipidus or by supposing the victim of high SCI to have pre-existing therapeutically compensated diabetes insipidus. The respective literatures on intensive care for BD organ donors and high SCI corroborate that the two conditions are somatically virtually identical. If SCI victims are alive at the level of the 'organism as a whole', then so must be BD patients (the only significant difference being consciousness). Comparison with SCI leads to the conclusion that if BD is to be equated with death, a more coherent reason must be adduced than that the body as a biological organism is dead.

  10. Employment self-disclosure of postsecondary graduates with learning disabilities: rates and rationales.

    Science.gov (United States)

    Madaus, Joseph W; Foley, Teresa E; McGuire, Joan M; Ruban, Lilia M

    2002-01-01

    One hundred thirty-two graduates with learning disabilities (LD) of a large, public, competitive postsecondary institution were surveyed to determine if they had self-disclosed their LD to their current employer and to provide the reasons for choosing to self-disclose or not to self-disclose. Based on a response rate of 67.4% (n = 89), the results indicated that 86.5% of the respondents were employed full time. Although nearly 90% of the respondents stated that their LD affected their work in some way, only 30.3% self-disclosed to their employer. Of those who had not self-disclosed, the majority reported that there was no reason or need to self-disclose. However, 46.1% reported not self-disclosing due to fear of a potentially negative impact in the workplace or due to a concern for job security. Specific rationales for disclosure and information related to the use of self-reported accommodations and strategies are presented.

  11. Early detection of ovarian cancer: background, rationale, and structure of the Yale Early Detection Program.

    Science.gov (United States)

    Schwartz, P. E.; Chambers, J. T.; Taylor, K. J.; Pellerito, J.; Hammers, L.; Cole, L. A.; Yang-Feng, T. L.; Smith, P.; Mayne, S. T.; Makuch, R.

    1991-01-01

    Ovarian cancer has received national attention as a highly virulent disease. Its lack of early warning symptoms and the failure to develop highly sensitive screening tests have led some physicians to recommend prophylactic oophorectomies to women with relatives who have had ovarian cancer. Others have recommended routine screening of otherwise normal women for CA 125, a circulating tumor marker, and ultrasound examinations. Each of these techniques is associated with substantial false-positive rates that could lead to unnecessary surgery. A review of epidemiologic data suggests that familial ovarian cancer kindreds are rare, but women with first-degree relatives who have had ovarian cancer have a significant risk themselves for developing ovarian cancer. In addition, women with a great number of ovulatory cycles are at an increased risk for the disease. Circulating tumor markers are frequently elevated in women with advanced ovarian cancer, but their value in early detection of ovarian cancer has yet to be established. Advances in endovaginal ultrasound and color Doppler flow technology have significantly improved our ability to assess pelvic organs. This article presents the background, rationale, and structure of the Yale Early Detection Program for ovarian cancer, whose goals are to identify the best techniques for diagnosing ovarian cancer in an early stage, to determine the frequency with which such tests should be employed, to assess false-positive results, and to identify women who might benefit from prophylactic oophorectomies. PMID:1810100

  12. Afatinib-based combination regimens for the treatment of solid tumors: rationale, emerging strategies and recent progress.

    Science.gov (United States)

    Bennouna, Jaafar; Moreno Vera, Shanti Ricardo

    2016-02-01

    In oncology, there is a clinical need for novel combination therapy regimens that maximize efficacy and delay resistance to individual treatment modalities. Given the role of aberrant ErbB receptor signaling in the pathogenesis of many human cancers, there is rationale for incorporating afatinib, an irreversible pan-ErbB tyrosine kinase inhibitor, into such combinations. This review focuses on: pharmacological properties of afatinib that facilitate its use in combination; preclinical rationale for the combination of afatinib with other agents; and recently completed, and ongoing, clinical trials of afatinib-based combinations across tumor types. Based on these data, we emphasize a number of areas of high unmet medical need that could benefit from afatinib-based combinations, including patients with relapsed/refractory non-small-cell lung cancer.

  13. Rationale and methodology of monitoring ambulatory blood pressure and arterial compliance in the Hypertension in the Very Elderly Trial

    OpenAIRE

    2006-01-01

    OBJECTIVE: This article describes the rationale and methodology for the monitoring of ambulatory blood pressure and arterial compliance in hypertensive patients aged 80 years and above. This is a side project of the Hypertension in the Very Elderly Trial. METHODS: The hypertension in the Very Elderly Trial is a multicentre, double-blind, randomized, placebo-controlled trial aiming to investigate the effect of active treatment on cardiovascular and other outcomes in hypertensive patients aged ...

  14. Rationale and clinical utility of the darunavir–cobicistat combination in the treatment of HIV/AIDS

    Directory of Open Access Journals (Sweden)

    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

  15. The Survey of the Health of Wisconsin (SHOW, a novel infrastructure for population health research: rationale and methods

    Directory of Open Access Journals (Sweden)

    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

  16. Expression of histamine receptors in the human endolymphatic sac: the molecular rationale for betahistine use in Menieres disease.

    Science.gov (United States)

    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

  17. Cellular phones for reducing battlefield stress: rationale and a preliminary research.

    Science.gov (United States)

    Riva, Giuseppe; Grassi, Alessandra; Villani, Daniela; Preziosa, Alessandra

    2007-01-01

    Battlefield stress is the consequence of man being exposed to the hostile environment of combat. Combat stress is specifically caused by man's feat of the dangers of combat, and is fueled and tempered by other variables such as morale, cohesion, fatigue, confidence, training and intensity of the combat. Treatment is often as simple as giving soldiers time to rest for a few hours or days, to get a shower and some sleep, to talk about the feelings they have in the presence of a counselor. Only in rare cases soldiers undergo more serious psychological treatment. One of the best strategies for dealing with stress is learning how to relax. However, relaxing is difficult to achieve in a battlefield. In this chapter we suggest the use of mobile multimedia technology--PDA/cellular phones--for the provision of advanced coping techniques suitable to the battlefield context. Specifically, we developed a protocol based on mobile narratives, to be experienced on mobile multimedia technology--3G cellular phones or PDAs--like the one now under development by the US Army within the "Soldier as a System--SaaS" and "Future Combat Systems--FCS" projects. Mobile narratives are audio-visual experiences, implemented on mobile devices, in which the narrative component is a critical aspect to induce a feeling of presence and engagement. Through the link between the feeling of presence and the emotional state, mobile narratives may be used to improve the mood state in their users. The rationale of the approach and a preliminary test of the proposed method are presented and discussed.

  18. The analysis and rationale behind the upgrading of existing standard definition thermal imagers to high definition

    Science.gov (United States)

    Goss, Tristan M.

    2016-05-01

    With 640x512 pixel format IR detector arrays having been on the market for the past decade, Standard Definition (SD) thermal imaging sensors have been developed and deployed across the world. Now with 1280x1024 pixel format IR detector arrays becoming readily available designers of thermal imager systems face new challenges as pixel sizes reduce and the demand and applications for High Definition (HD) thermal imaging sensors increases. In many instances the upgrading of existing under-sampled SD thermal imaging sensors into more optimally sampled or oversampled HD thermal imaging sensors provides a more cost effective and reduced time to market option than to design and develop a completely new sensor. This paper presents the analysis and rationale behind the selection of the best suited HD pixel format MWIR detector for the upgrade of an existing SD thermal imaging sensor to a higher performing HD thermal imaging sensor. Several commercially available and "soon to be" commercially available HD small pixel IR detector options are included as part of the analysis and are considered for this upgrade. The impact the proposed detectors have on the sensor's overall sensitivity, noise and resolution is analyzed, and the improved range performance is predicted. Furthermore with reduced dark currents due to the smaller pixel sizes, the candidate HD MWIR detectors are operated at higher temperatures when compared to their SD predecessors. Therefore, as an additional constraint and as a design goal, the feasibility of achieving upgraded performance without any increase in the size, weight and power consumption of the thermal imager is discussed herein.

  19. Costing in Radiology and Health Care: Rationale, Relativity, Rudiments, and Realities.

    Science.gov (United States)

    Rubin, Geoffrey D

    2017-02-01

    Costs direct decisions that influence the effectiveness of radiology in the care of patients on a daily basis. Yet many radiologists struggle to harness the power of cost measurement and cost management as a critical path toward establishing their value in patient care. When radiologists cannot articulate their value, they risk losing control over how imaging is delivered and supported. In the United States, recent payment trends directing value-based payments for bundles of care advance the imperative for radiology providers to articulate their value. This begins with the development of an understanding of the providers' own costs, as well as the complex interrelationships and imaging-associated costs of other participants across the imaging value chain. Controlling the costs of imaging necessitates understanding them at a procedural level and quantifying the costs of delivering specific imaging services. Effective product-level costing is dependent on a bottom-up approach, which is supported through recent innovations in time-dependent activity-based costing. Once the costs are understood, they can be managed. Within the high fixed cost and high overhead cost environment of health care provider organizations, stakeholders must understand the implications of misaligned top-down cost management approaches that can both paradoxically shift effort from low-cost workers to much costlier professionals and allocate overhead costs counterproductively. Radiology's engagement across a broad spectrum of care provides an excellent opportunity for radiology providers to take a leading role within the health care organizations to enhance value and margin through principled and effective cost management. Following a discussion of the rationale for measuring costs, this review contextualizes costs from the perspectives of a variety of stakeholders (relativity), discusses core concepts in how costs are classified (rudiments), presents common and improved methods for measuring

  20. Rationale, design, methodology and hospital characteristics of the first gulf acute heart failure registry (gulf care

    Directory of Open Access Journals (Sweden)

    Kadhim J Sulaiman

    2014-01-01

    Full Text Available Background: There is paucity of data on heart failure (HF in the Gulf Middle East. The present paper describes the rationale, design, methodology and hospital characteristics of the first Gulf acute heart failure registry (Gulf CARE. Materials and Methods: Gulf CARE is a prospective, multicenter, multinational registry of patients >18 year of age admitted with diagnosis of acute HF (AHF. The data collected included demographics, clinical characteristics, etiology, precipitating factors, management and outcomes of patients admitted with AHF. In addition, data about hospital readmission rates, procedures and mortality at 3 months and 1-year follow-up were recorded. Hospital characteristics and care provider details were collected. Data were entered in a dedicated website using an electronic case record form. Results: A total of 5005 consecutive patients were enrolled from February 14, 2012 to November 13, 2012. Forty-seven hospitals in 7 Gulf States (Oman, Saudi Arabia, Yemen, Kuwait, United Gulf Emirates, Qatar and Bahrain participated in the project. The majority of hospitals were community hospitals (46%; 22/47 followed by non-University teaching (32%; 15/47 and University hospitals (17%. Most of the hospitals had intensive or coronary care unit facilities (93%; 44/47 with 59% (28/47 having catheterization laboratory facilities. However, only 29% (14/47 had a dedicated HF clinic facility. Most patients (71% were cared for by a cardiologist. Conclusions: Gulf CARE is the first prospective registry of AHF in the Middle East, intending to provide a unique insight into the demographics, etiology, management and outcomes of AHF in the Middle East. HF management in the Middle East is predominantly provided by cardiologists. The data obtained from this registry will help the local clinicians to identify the deficiencies in HF management as well as provide a platform to implement evidence based preventive and treatment strategies to reduce the burden

  1. Monitoring rationale, strategy, issues, and methods: UMRR-EMP LTRMP fish component

    Science.gov (United States)

    Ickes, Brian S.; Sauer, Jennifer S.; Rogala, James T.

    2014-01-01

    The Long Term Resource Monitoring Program (LTRMP), an element of the multiagency partnership Upper Mississippi River Restoration-Environmental Management Program, has been monitoring fishes in the Upper Mississippi River System (UMRS) for over two decades, using scientific and highly standardized methods. Today, the LTRMP’s data assets represent one of the world’s largest and most extensive datasets on a great river. Methods and procedures used over the past two decades have been documented and have proven a key tool towards gaining data that are (a) scientifically valid, (b) comparable over time, and (c) comparable over space. These procedures manuals coordinate and standardize methods, procedures, and field behaviors in the execution of long-term monitoring, permitting the informed management and control of important sources of error actually under program control. As LTRMP databases have matured in scope and accumulated more years' worth of data, their utility in research and management in the UMRS basin has increased notably. To maximize their utility, data users need not only be aware of “how the data were collected,” as portrayed in the procedures manuals, but also “why the data were collected in the way they were, at the scales they were, and in the manner that they were.” Whereas the procedures manuals contribute information as to the “how” the data were gained, this document seeks to contribute information as to the “why.” As such, this document is intended to be a companion document to the procedures manuals. Herein, we present information on the rationale for monitoring nearly one-fifth of the entire North American freshwater fish fauna (representing the greatest freshwater fish diversity on the planet at temperate latitudes); strategies employed and their reasoning; and discussions on issues associated with the sampling design itself, data arising therefrom, and uses of those data in different contexts.

  2. A rationale for maintaining the double containment requirement for plutonium shipments

    Energy Technology Data Exchange (ETDEWEB)

    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.

  3. Functional neuroanatomy and the rationale for using EEG biofeedback for clients with Asperger's syndrome.

    Science.gov (United States)

    Thompson, Lynda; Thompson, Michael; Reid, Andrea

    2010-03-01

    This paper reviews the symptoms of Asperger's Syndrome (AS), a disorder along the autism continuum, and highlights research findings with an emphasis on brain differences. Existing theories concerning AS are described, including theory of mind (Hill and Frith in Phil Trans Royal Soc Lond, Bull 358:281-289, 2003), mirror neuron system (Ramachandran and Oberman in Sci Am 295(5):62-69, 2006), and Porges' (Ann N Y Acad Sci 1008:31-47, 2003, The neurobiology of autism, Johns Hopkins University Press, Baltimore, 2004) polyvagal theory. (A second paper, Outcomes using EEG Biofeedback Training in Clients with Asperger's Syndrome, summarizes clinical outcomes obtained with more than 150 clients.) Patterns seen with QEEG assessment are then presented. Single channel assessment at the vertex (CZ) reveals patterns similar to those found in Attention-Deficit/Hyperactivity Disorder. Using 19-channel data, significant differences (z-scores > 2) were found in the amplitude of both slow waves (excess theta and/or alpha) and fast waves (beta) at various locations. Differences from the norm were most often found in mirror neuron areas (frontal, temporal and temporal-parietal). There were also differences in coherence patterns, as compared to a normative database (Neuroguide). Low Resolution Electromagnetic Tomography Analysis (Pascual-Marqui et al. in Methods Find Exp Clin Pharmacol 24C:91-95, 2002) suggested the source of the abnormal activity was most often the anterior cingulate. Other areas involved included the amygdala, uncus, insula, hippocampal gyrus, parahippocampal gyrus, fusiform gyrus, and the orbito-frontal and/or ventromedial areas of the prefrontal cortex. Correspondence between symptoms and the functions of the areas found to have abnormalities is evident and those observations are used to develop a rationale for using EEG biofeedback, called neurofeedback (NFB), intervention. NFB training is targeted to improve symptoms that include difficulty reading and mirroring

  4. Weight loss intervention for young adults using mobile technology: design and rationale of a randomized controlled trial – Cell phone Intervention for You (CITY)

    Science.gov (United States)

    Batch, Bryan C.; Tyson, Crystal; Bagwell, Jacqueline; Corsino, Leonor; Intille, Stephen; Lin, Pao-Hwa; Lazenka, Tony; Bennett, Gary; Bosworth, Hayden B.; Voils, Corrine; Grambow, Steven; Sutton, Aziza; Bordogna, Rachel; Pangborn, Matthew; Schwager, Jenifer; Pilewski, Kate; Caccia, Carla; Burroughs, Jasmine; Svetkey, Laura P.

    2014-01-01

    Background The obesity epidemic has spread to young adults, leading to significant public health implications later in adulthood. Intervention in early adulthood may be an effective public health strategy for reducing the long-term health impact of the epidemic. Few weight loss trials have been conducted in young adults. It is unclear what weight loss strategies are beneficial in this population. Purpose To describe the design and rationale of the NHLBI-sponsored Cell Phone Intervention for You (CITY) study, which is a single center, randomized three-arm trial that compares the impact on weight loss of 1) a behavioral intervention that is delivered almost entirely via cell phone technology (Cell Phone group); and 2) a behavioral intervention delivered mainly through monthly personal coaching calls enhanced by self-monitoring via cell phone (Personal Coaching group), each compared to; 3) a usual care, advice-only control condition. Methods A total of 365 community-dwelling overweight/obese adults aged 18–35 years were randomized to receive one of these three interventions for 24 months in parallel group design. Study personnel assessing outcomes were blinded to group assignment. The primary outcome is weight change at 12 months. We hypothesize that each active intervention will cause more weight loss than the usual care condition. Study completion is anticipated in 2014. Conclusions If effective, implementation of the CITY interventions could mitigate the alarming rates of obesity in young adults through promotion of weight loss. PMID:24462568

  5. Simulation-guided phase 3 trial design to evaluate vaccine effectiveness to prevent Ebola virus disease infection: Statistical considerations, design rationale, and challenges.

    Science.gov (United States)

    Vandebosch, An; Mogg, Robin; Goeyvaerts, Nele; Truyers, Carla; Greenwood, Brian; Watson-Jones, Debby; Herrera-Taracena, Guillermo; Parys, Wim; Vangeneugden, Tony

    2016-02-01

    Starting in December 2013, West Africa was overwhelmed with the deadliest outbreak of Ebola virus known to date, resulting in more than 27,500 cases and 11,000 deaths. In response to the epidemic, development of a heterologous prime-boost vaccine regimen was accelerated and involved preparation of a phase 3 effectiveness study. While individually randomized controlled trials are widely acknowledged as the gold standard for demonstrating the efficacy of a candidate vaccine, there was considerable debate on the ethical appropriateness of these designs in the context of an epidemic. A suitable phase 3 trial must convincingly ensure unbiased evaluation with sufficient statistical power. In addition, efficient evaluation of a vaccine candidate is required so that an effective vaccine can be immediately disseminated. This manuscript aims to present the statistical and modeling considerations, design rationale and challenges encountered due to the emergent, epidemic setting that led to the selection of a cluster-randomized phase 3 study design under field conditions.

  6. The Land Use Model Intercomparison Project (LUMIP) contribution to CMIP6: rationale and experimental design

    Science.gov (United States)

    Lawrence, David M.; Hurtt, George C.; Arneth, Almut; Brovkin, Victor; Calvin, Kate V.; Jones, Andrew D.; Jones, Chris D.; Lawrence, Peter J.; de Noblet-Ducoudré, Nathalie; Pongratz, Julia; Seneviratne, Sonia I.; Shevliakova, Elena

    2016-09-01

    complementary to simulations requested in the CMIP6 DECK and historical simulations and other CMIP6 MIPs including ScenarioMIP, C4MIP, LS3MIP, and DAMIP. LUMIP includes a two-phase experimental design. Phase one features idealized coupled and land-only model simulations designed to advance process-level understanding of LULCC impacts on climate, as well as to quantify model sensitivity to potential land-cover and land-use change. Phase two experiments focus on quantification of the historic impact of land use and the potential for future land management decisions to aid in mitigation of climate change. This paper documents these simulations in detail, explains their rationale, outlines plans for analysis, and describes a new subgrid land-use tile data request for selected variables (reporting model output data separately for primary and secondary land, crops, pasture, and urban land-use types). It is essential that modeling groups participating in LUMIP adhere to the experimental design as closely as possible and clearly report how the model experiments were executed.

  7. Documenting the rationale and psychometric characteristics of patient reported outcomes for labeling and promotional claims: the PRO Evidence Dossier.

    Science.gov (United States)

    Revicki, Dennis A; Gnanasakthy, Ari; Weinfurt, Kevin

    2007-05-01

    The Food and Drug Administration (FDA) and European Medicines Agency (EMEA) are willing to consider including information on patient reported outcomes (PROs) in product labeling and advertising. Pharmaceutical industry researchers must provide sufficient evidence supporting PRO benefit before an approval may be granted. This report describes the purpose and content of a PRO Evidence Dossier, which consists of important information supporting PRO claims. The dossier should be completed by pharmaceutical industry or other researchers to document the planning of the PRO assessment strategy, psychometric evidence, desired target labeling statements, and the clinical trial evidence of PRO benefits. The systematic reporting and documentation of information on the rationale for including PROs, rationale for the selection of specific PRO instruments, evidence on the psychometric qualities of the PRO measures, and guidelines for interpreting PRO findings will facilitate achieving a PRO labeling or promotional claim. Combining all the relevant information into a single document will facilitate the review and evaluation process for clinical and regulatory reviewers. The PRO Evidence Dossier may also be helpful to industry and academic researchers in identifying further information that will need to be developed to support the clinical development program and the PRO endpoints.

  8. Rationale, design, and sample characteristics of a practical randomized trial to assess a weight loss intervention for low-income women: the Weight-Wise II Program.

    Science.gov (United States)

    Samuel-Hodge, Carmen D; Garcia, Beverly A; Johnston, Larry F; Kraschnewski, Jennifer L; Gustafson, Alison A; Norwood, Arnita F; Glasgow, Russell E; Gold, Alison D; Graham, John W; Evenson, Kelly R; Stearns, Sally C; Gizlice, Ziya; Keyserling, Thomas C

    2012-01-01

    Obesity is common among low-income mid-life women, yet most published weight loss studies have not focused on this population and have been highly resourced efficacy trials. Thus, practical type 2 translational studies are needed to evaluate weight loss interventions for low-income women. In this paper, we present the rationale, study design, and baseline characteristics of a type 2 translational study that evaluates both the processes and outcomes of a weight loss intervention for low-income women given at 6 county health departments in North Carolina. Key features of this study include random selection of study sites, intervention delivery by current staff at study sites, efforts to integrate the intervention with local community resources, a focus on evaluating the processes of translation using the RE-AIM framework, use of an evidence-based weight loss intervention, a detailed description of participant recruitment and representativeness, and a practical randomized trial designed to assess the effectiveness of the intervention. Of 81 health departments invited to participate, 30 (37%) were eligible and willing, and 6 were selected at random to deliver the intervention. Of 432 potential participants screened by phone, 213 (49%) were eligible and of these, 189 (89%) completed baseline measures and were randomized to receive a 5-month weight loss intervention or a delayed intervention. The mean age was 51, mean BMI 37 kg/m(2), 53% were African American, and 43% had no health insurance. The results of this study should be informative to key stakeholders interested in real world weight loss interventions for low-income mid-life women.

  9. Rationale for the development of IMC-3G3, a fully human immunoglobulin G subclass 1 monoclonal antibody targeting the platelet-derived growth factor receptor alpha.

    Science.gov (United States)

    Shah, Gaurav D; Loizos, Nick; Youssoufian, Hagop; Schwartz, Jonathan D; Rowinsky, Eric K

    2010-02-15

    A large body of evidence suggests that the platelet-derived growth factor (PDGF) family and associated receptors are potential targets in oncology therapeutic development because of their critical roles in the proliferation and survival of various cancers and in the regulation and growth of the tumor stroma and blood vessels. Several small molecules that nonspecifically target the PDGF signaling axis are in current use or development as anticancer therapies. However, for the majority of these agents, PDGF and its receptors are neither the primary targets nor the principal mediators of anticancer activity. IMC-3G3, a fully human monoclonal antibody of the immunoglobulin G subclass 1, specifically binds to the human PDGF receptor alpha (PDGFRalpha) with high affinity and blocks PDGF ligand binding and PDGFRalpha activation. The results of preclinical studies and the frequent expression of PDGFRalpha in many types of cancer and in cancer-associated stroma support a rationale for the clinical development of IMC-3G3. Currently, IMC-3G3 is being evaluated in early clinical development for patients with several types of solid malignancies.

  10. Building the rationale and structure for a complex physical therapy intervention within the context of a clinical trial: a multimodal individualized treatment for patients with hip osteoarthritis.

    Science.gov (United States)

    Bennell, Kim L; Egerton, Thorlene; Pua, Yong-Hao; Abbott, J Haxby; Sims, Kevin; Buchbinder, Rachelle

    2011-10-01

    Evaluating the efficacy of complex interventions such as multimodal, impairment-based physical therapy treatments in randomized controlled trials is essential to inform practice and compare relative benefits of available treatment options. Studies of physical therapy interventions using highly standardized intervention protocols, although methodologically rigorous, do not necessarily reflect "real-world" clinical practice, and in many cases results have been disappointing. Development of a complex intervention that includes multiple treatment modalities and individualized treatment technique selection requires a systematic approach to designing all aspects of the intervention based on theory, evidence, and practical constraints. This perspective article outlines the development of the rationale and structure of a multimodal physical therapy program for painful hip osteoarthritis to be assessed in a clinical trial. The resulting intervention protocol comprises a semi-structured program of exercises and manual therapy, advice, physical activity, and optional prescription of a gait aid that is standardized, yet can be individualized according to physical assessment and radiographic findings. The program is evidence based and reflects contemporary physical therapist practice, while also being reproducible and reportable. This perspective article aims to encourage physical therapy researchers involved in evaluation of complex interventions to better document their own intervention development, as well as the outcomes, thus generating a body of knowledge about the development processes and protocols that is generalizable to the real-world complexity of providing physical therapy to individual patients.

  11. 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).

    Science.gov (United States)

    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.

  12. Pre-attentive processing and schizophrenia: animal studies.

    NARCIS (Netherlands)

    Ellenbroek, B.A.

    2004-01-01

    RATIONALE: Schizophrenia is characterized by a large variety of cognitive symptoms, among which information processing deficits have been extensively studied. So far, these aspects have been found to be remarkably stable and effective treatment is still lacking. Traditionally, information processing

  13. Regadenoson-stress myocardial CT perfusion and single-photon emission CT: rationale, design, and acquisition methods of a prospective, multicenter, multivendor comparison.

    Science.gov (United States)

    Cury, Ricardo C; Kitt, Therese M; Feaheny, Kathleen; Akin, Jamie; George, Richard T

    2014-01-01

    Pharmacologic stress myocardial CT perfusion (CTP) has been reported to be a viable imaging modality for detection of myocardial ischemia compared with single-photon emission CT (SPECT) in several single-center studies. However, regadenoson-stress CTP has not previously been compared with SPECT in a multicenter, multivendor study. The rationale and design of a phase 2, randomized, cross-over study of regadenoson-stress myocardial perfusion imaging by CTP compared with SPECT are described herein. The study will be conducted at approximately 25 sites by using 6 different CT scanner models, including 64-, 128-, 256-, and 320-slice systems. Subjects with known/suspected coronary artery disease will be randomly assigned to 1 of 2 imaging procedure sequences; rest and regadenoson-stress SPECT on day 1, then regadenoson-stress CTP and rest CTP/coronary CT angiography (same acquisition) on day 2; or regadenoson-stress CTP and rest CTP/CT angiography on day 1, then rest and regadenoson-stress SPECT on day 2. The prespecified primary analysis examines the agreement rate between CTP and SPECT for detecting or excluding ischemia (≥2 or 0-1 reversible defects, respectively), as assessed by 3 independent blinded readers for each modality. Non-inferiority will be indicated if the lower boundary of the 95% CI for the agreement rate is within 0.15 of 0.78 (the observed agreement rate in the regadenoson pivotal trials). The protocol described herein will support the first evaluation of regadenoson-stress CTP by using multiple scanner types compared with SPECT.

  14. Accessing the Long-Lived Triplet Excited States in Transition-Metal Complexes: Molecular Design Rationales and Applications.

    Science.gov (United States)

    Cui, Xiaoneng; Zhao, Jianzhang; Mohmood, Zafar; Zhang, Caishun

    2016-02-01

    Transition-metal complex triplet photosensitizers are versatile compounds that have been widely used in photocatalysis, photovoltaics, photodynamic therapy (PDT) and triplet-triplet annihilation (TTA) upconversion. The principal photophysical processes in these applications are the intermolecular energy transfer or electron transfer. One of the major challenges facing these triplet photosensitizers is the short triplet-state lifetime, which is detrimental to the above-mentioned photophysical processes. In order to address this challenge, transition-metal complexes showing long-lived triplet excited states are highly desired. This review article summarizes the development of this fascinating area, including the molecular design rationales, the principal photophysical properties, and the applications of these complexes in PDT and TTA upconversion.

  15. A rationale for the development of thermally stable nanostructured CeO2-ZrO2-containing mixed oxides

    Institute of Scientific and Technical Information of China (English)

    Roberta Di Monte; Jan Ka(s)par; Heather Bradshaw; Colin Norman

    2008-01-01

    CeO2-ZeO2 solid solutions are extensively used as oxygen storage promoters in the current automotive three-way catalysts. High thermal stability of the textural properties is one of the most important requirements for practical application since temperatures up to 1273 K are easily experienced by these materials under real working conditions. In the present paper, we investigated how hydrothermal treatments applied to cakes of doped and undoped ZrO2-rich CeO2-ZrO2 precursors might improve the thermal stability of the final CeO2-ZrO2 solid solution. A rationale was developed that allowed to correlate the morphology of the hydrothermally treated cake with the thermal stability at 1273 K of the final product, which did not depend on the composition of the mixed oxides.

  16. Application of design rationale for a robotic system for single-incision laparoscopic surgery and natural orifice transluminal endoscopic surgery.

    Science.gov (United States)

    Yao, Wei; Childs, Peter R N

    2013-07-01

    Current endoscopes and instruments are inadequate in some respects for complex intra-abdominal surgery because they are too flexible and cannot provide robust grasping and anatomic retraction. Minimal invasive surgery devices represent a sophisticated class of mechanical instruments making use of a range of mechanisms integrated into modular platforms that can be combined to undertake complex medical procedures. Although the machine elements concerned represent classic mechanical engineering devices, issues of miniaturization, surgical procedure compliance and location control conspire to present a design challenge. In order to capture, document and resolve the design requirements for this complex application, quality functional deployment has been applied in combination with design rationale, captured through issue-based information system mapping. This article reports the use of these tools to produce robot designs with improved dexterity and triangulation that are basic requirements in laparoscopy.

  17. Rationale and Development of a Security Assurance Index with Application toward the Development of a World Risk Index

    Energy Technology Data Exchange (ETDEWEB)

    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.

  18. Rationale and design for the blood pressure intervention of the Action to Control Cardiovascular Risk in Diabetes (ACCORD) trial.

    Science.gov (United States)

    Cushman, William C; Grimm, Richard H; Cutler, Jeffrey A; Evans, Gregory W; Capes, Sarah; Corson, Marshall A; Sadler, Laurie S; Alderman, Michael H; Peterson, Kevin; Bertoni, Alain; Basile, Jan N

    2007-06-18

    The Action to Control Cardiovascular Disease in Diabetes (ACCORD) blood pressure trial is an unmasked, open-label, randomized trial with a sample size of 4,733 participants. This report describes the rationale, design, and methods of the blood pressure interventions in ACCORD. Participants eligible for the blood pressure trial are randomized to 1 of 2 groups with different treatment goals: systolic blood pressure <120 mm Hg for the more intensive goal and systolic blood pressure <140 mm Hg for the less intensive goal. The primary outcome measure for the trial is the first occurrence of a major cardiovascular disease (CVD) event, specifically nonfatal myocardial infarction or stroke, or cardiovascular death during a follow-up period ranging from 4-8 years. The ACCORD blood pressure trial should provide the first definitive clinical trial data on the possible benefit of treating to a more aggressive systolic blood pressure goal in reducing CVD events in patients with diabetes mellitus.

  19. Identification of potentially safe promising fungal cell factories for the production of polyketide natural food colorants using chemotaxonomic rationale

    DEFF Research Database (Denmark)

    Mapari, Sameer Shamsuddin; Meyer, Anne S.; Thrane, Ulf

    2009-01-01

    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 biosynthesis of which...... provide readily available additional and/or alternative sources of natural colorants that are independent of agro-climatic conditions. With an appropriately selected fungus; using in particular chemotaxonomy as a guide, the fungal natural colorants could be produced in high yields by using the optimized...... cultivation technology. This approach could secure efficient production of pigments avoiding use of genetic manipulation. Results: Polyketide pigment producing ascomycetous fungi were evaluated for their potential as production organisms based on a priori knowledge on species-specific pigment and potential...

  20. Design Rationale Behind the Serious Self-Regulation Game Intervention "Balance It" : Overweight Prevention Among Secondary Vocational Education Students in The Netherlands

    NARCIS (Netherlands)

    Spook, Jorinde E; Paulussen, Theo; Paulissen, Rosie; Visschedijk, Gillian; Kok, Gerjo; van Empelen, Pepijn

    2015-01-01

    OBJECTIVE: This article describes the design rationale behind a serious self-regulation game intervention. The aim of the game is to promote healthy dietary intake and physical activity among secondary vocational educational students in The Netherlands (approximately 16-20 years of age). MATERIALS A

  1. Design Rationale Behind the Serious Self-Regulation Game Intervention “Balance-It”: Overweight Prevention Among Secondary Vocational Education Students in the Netherlands

    NARCIS (Netherlands)

    Spook, J.E.; Paulussen, T.G.W.M.; Paulissen, R.T; Visschedijk, G.C.; Kok, G.; Empelen, P. van

    2015-01-01

    Objective: This article describes the design rationale behind a serious self-regulation game intervention. The aim of the game is to promote healthy dietary intake and physical activity among secondary vocational educational students in The Netherlands (approximately 16-20 years of age). Materials a

  2. Efficacy and safety of oral strontium ranelate for the treatment of knee osteoarthritis: rationale and design of randomised, double-blind, placebo-controlled trial

    Directory of Open Access Journals (Sweden)

    Cyrus Cooper

    2013-01-01

    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.

  3. Considerations in the rationale, design and methods of the Strategic Timing of AntiRetroviral Treatment (START) study

    DEFF Research Database (Denmark)

    Babiker, Abdel G; Emery, Sean; Fätkenheuer, Gerd

    2013-01-01

    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...... is not feasible with currently available drugs. The optimal time to start ART for asymptomatic HIV infection is controversial and remains one of the key unanswered questions in the clinical management of HIV-infected individuals....... with an increased risk of serious non-AIDS (SNA) diseases including cardiovascular, renal, and liver diseases and non-AIDS-defining cancers. Although combination antiretroviral treatment (ART) has resulted in a substantial decrease in morbidity and mortality in persons with HIV infection, viral eradication...

  4. A systems BIOlogy Study to TAilored Treatment in Chronic Heart Failure : rationale, design, and baseline characteristics of BIOSTAT-CHF

    NARCIS (Netherlands)

    Voors, Adriaan A.; Anker, Stefan D.; Cleland, John G.; Dickstein, Kenneth; Filippatos, Gerasimos; van der Harst, Pim; Hillege, Hans L.; Lang, Chim C.; ter Maaten, Jozine M.; Ng, Leong; Ponikowski, Piotr; Samani, Nilesh J.; van Veldhuisen, Dirk J.; Zannad, Faiz; Zwinderman, Aeilko H.; Metra, Marco

    2016-01-01

    AimsDespite major improvements in pharmacological and device treatments, heart failure remains a syndrome with high morbidity and mortality, poor quality of life, and high health-care costs. Given the extensive heterogeneity among patients with heart failure, substantial differences in the response

  5. Toward 20 T magnetic resonance for human brain studies: opportunities for discovery and neuroscience rationale.

    Science.gov (United States)

    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.

  6. Limited agreement exists between rationale and practice in athletes' supplement use for maintenance of health: a retrospective study

    Directory of Open Access Journals (Sweden)

    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.

  7. A randomized controlled trial to prevent childhood obesity through early childhood feeding and parenting guidance: Rationale and design of study

    Science.gov (United States)

    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 ...

  8. Targeting Body Image Schema for Smoking Cessation among College Females: Rationale, Program Description, and Pilot Study Results

    Science.gov (United States)

    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…

  9. Rationale and design of MinerAlocorticoid Receptor antagonist Tolerability Study-Heart Failure (ARTS-HF)

    DEFF Research Database (Denmark)

    Pitt, Bertram; Anker, Stefan D; Böhm, Michael

    2015-01-01

    2 diabetes mellitus and/or chronic kidney disease (CKD) will be randomized within 7 days of emergency presentation to hospital for worsening chronic HF to receive finerenone (one of five doses in the range 2.5-20.0 mg once daily) or eplerenone (25 mg every second day to 50 mg once daily for 90 days...... with eplerenone. Other objectives are to assess the effects of finerenone on a composite clinical endpoint (death from any cause, cardiovascular hospitalizations, or emergency presentations for worsening chronic HF), and on changes in health-related quality of life from baseline. CONCLUSIONS: ARTS-HF is the first...... phase 2b clinical trial to investigate the effects of finerenone on plasma NT-proBNP in a high-risk population of patients who have worsening chronic HF with type 2 diabetes mellitus and/or CKD presenting at the emergency department....

  10. A Rationale for the Outcomes of Insurgencies: A Comparison Case Study Between Insurgencies in Peru and Nepal

    Science.gov (United States)

    2014-12-01

    source of inspiration and taking care of both me and our child , and for demonstrating extreme patience during stressful hours. I am also thankful to my...creates a syndrome of weak central authority, unstable domestic coalitions, and high-energy mass politics.”108 Nepal faced a similar situation, in...bureaucrats belonged to the middle class and they did not support the CPN(M). The CPN(M) leadership could not create a cleavage within the Nepalese

  11. The gulf implantable cardioverter-defibrillator registry: Rationale, methodology, and implementation

    Directory of Open Access Journals (Sweden)

    Alawi A Alsheikh-Ali

    2015-01-01

    Conclusions: Gulf ICD is the first prospective, observational, multi-center, and multinational study of the characteristics and, the outcomes of patients receiving ICDs in the Arab Gulf region. The study will provide valuable insights into the utilization of and outcomes related to ICD therapy in the Gulf region.

  12. Patient and provider satisfaction with the use of telemedicine: Overview and rationale for cautious enthusiasm

    Directory of Open Access Journals (Sweden)

    Whitten P

    2005-01-01

    Full Text Available Telemedicine research addressing user satisfaction abounds in academic literature. Results from patient satisfaction studies indicate exceptionally high levels of perceived satisfaction, often above the rates of expected satisfaction for traditional forms of health delivery. Results from provider satisfaction studies are also generally quite positive; however, data from providers point to higher concerns with delivery barriers and challenges. Even though data from patient and provider satisfaction research suggests overwhelming optimism for this delivery modality, this paper urges cautious embracement of these results for several reasons. First, many of the studies exhibit serious methodological weaknesses related to design and data collection instruments. In addition, the construct of satisfaction is largely undefined and is not clear. Even recognizing these caveats, the results of the study do offer some evidence that patient satisfaction will not impede the deployment of telemedicine, but provider satisfaction merits additional study.

  13. Rats are the smart choice: Rationale for a renewed focus on rats in behavioral genetics.

    Science.gov (United States)

    Parker, Clarissa C; Chen, Hao; Flagel, Shelly B; Geurts, Aron M; Richards, Jerry B; Robinson, Terry E; Solberg Woods, Leah C; Palmer, Abraham A

    2014-01-01

    Due in part to their rich behavioral repertoire rats have been widely used in behavioral studies of drug abuse-related traits for decades. However, the mouse became the model of choice for researchers exploring the genetic underpinnings of addiction after the first mouse study was published demonstrating the capability of engineering the mouse genome through embryonic stem cell technology. The sequencing of the mouse genome and more recent re-sequencing of numerous inbred mouse strains have further cemented the status of mice as the premier mammalian organism for genetic studies. As a result, many of the behavioral paradigms initially developed and optimized for rats have been adapted to mice. However, numerous complex and interesting drug abuse-related behaviors that can be studied in rats are very difficult or impossible to adapt for use in mice, impeding the genetic dissection of those traits. Now, technological advances have removed many of the historical limitations of genetic studies in rats. For instance, the rat genome has been sequenced and many inbred rat strains are now being re-sequenced and outbred rat stocks are being used to fine-map QTLs. In addition, it is now possible to create "knockout" rats using zinc finger nucleases (ZFN), transcription activator-like effector nucleases (TALENs) and related techniques. Thus, rats can now be used to perform quantitative genetic studies of sophisticated behaviors that have been difficult or impossible to study in mice. This article is part of a Special Issue entitled 'NIDA 40th Anniversary Issue'.

  14. Ferrocyanide Safety Program rationale for removing six tanks from the safety watch list

    Energy Technology Data Exchange (ETDEWEB)

    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. Mirtazapine in Veterinary Medicine a Pharmacological Rationale for its Application in Chronic Pain

    OpenAIRE

    2012-01-01

    Problem statement: Many recent studies have shown that antidepressant agents have analgesic effects in addition to their intended primary actions. The Tricyclic Antidepressants (TCAs) have been recognized as an effective first-line treatment of human neuropathic pain but unfortunately they display a wide range of side effects. Recent studies have shown that Selective Serotonin Reuptake Inhibitors (SSRI) also have potential analgesic effects, albeit of a lower potency compared with the TCAs. D...

  16. Novel neurotherapeutics in psychiatry: use and rationale of transcranial direct current stimulation in major depressive disorder

    Directory of Open Access Journals (Sweden)

    Adriano H. Moffa

    2014-04-01

    Full Text Available Background : Transcranial direct current stimulation (tDCS is a novel non-pharmacological intervention being investigated for the treatment of major depressive disorder (MDD. Objective : To perform an updated review of tDCS for MDD. Method : Systematic review in Medline/PubMed and other databases of all clinical studies evaluating the clinical efficacy of tDCS in MDD, from the first date available to December/2013. Results : Out of 55 articles, 24 were included, being 6 open-label studies; 8 randomized, double-blind, sham-controlled trials; 2 follow-up studies; 2 meta-analyses and 6 case reports. We observed an improvement of 20-40% in depressive symptoms, being slightly better in open studies. Five randomized clinical trials displayed positive results. The meta-analyses presented mixed results; although none included the study of Brunoni et al. (2013 that represents almost 50% of the evaluated sample. Open-label studies and case reports also investigated tDCS in bipolar depression, post-stroke depression and employed different parameters of stimulation. Discussion : TDCS is a novel, promising treatment for MDD. Definite evidence from large, ongoing clinical trials will be available in the next years.

  17. Diagnosis and Management of Iron Deficiency in CKD: A Summary of the NICE Guideline Recommendations and Their Rationale.

    Science.gov (United States)

    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.

  18. Management of stress and stress-related diseases: Emerging computer-based technologies and the rationale for clinical laboratory assessment

    Directory of Open Access Journals (Sweden)

    Ezekiel Uba Nwose

    2009-01-01

    Full Text Available Background : Over the years, the issue of stress management in mental health has been discussed without reference to the clinical laboratory perspectives. Translational research and the vast array of emerging diagnostic technologies in alternative medical practice are now bridging the gap. While it would be scientific arrogance for the clinical practitioner and scientist to ignore the trend, the new technologies seeking clinical acceptability necessarily require expatiation of the scientific aspects of their products. Aims : This commentary builds on a comparative critical review to further our hypothesis that oxidative stress is the biochemical basis of the emerging computer-based diagnostic technologies. Materials & Method : The available information on Computer Meridian Diagnostics, Neuropattern and Virtual Scanning technologies were critically reviewed. The differences and similarities were articulated. Results : The technologies seem different, but have similarities that have not been articulated before. The seemingly different theories are traceable to Russian scientists and are based upon stress-induced adrenal secretions and the associated effect on glucose metabolism. The therapeutic effects of antioxidant nutrition, exercise or relaxation that are inherent in the technologies are highlighted. Conclusion : This commentary furthers explanation of the alterations in antioxidant activities as a result of biofeedback, oxidative stress and/or physiological effects as the biochemical basis of the technologies. The place for antioxidant indices and whole blood viscosity are also highlighted. This provides a rationale for the evaluation of available clinical diagnostic tests both to validate the technologies and as clinical laboratory correlates in stress management.

  19. The scientific rationale behind data gathering for sections 199 and 200 for environmental emergency plans under CEPA

    Energy Technology Data Exchange (ETDEWEB)

    Rudin-Brown, P.; Ketcheson, K. [Environment Canada, Ottawa, ON (Canada)

    2002-07-01

    Section 199 of the Canadian Environmental Protection Act (CEPA) 199 is a new legislative mandate which requires Environment Canada to determine which substances on the List of Toxic Substances need and Environmental Emergency Plan. Section 200 of CEPA 199 ensures that appropriate risk management measures are adopted and implemented for all possible risks associated with the manufacture, storage and use of toxic and hazardous substances in Canada. This paper explained the scientific rationale for the information that has been collected to judge whether a chemical needs an environmental emergency plan under sections 199 and 200 under CEPA 199. The paper also highlights the major categories of information that are considered important in classifying the hazardous properties of a chemical. The main interest in compiling a hazard assessment are the physical characteristics affecting a substance's flammability, and if toxic, its ability to concentrate or disperse. These physical properties include state, solubility, specific gravity, boiling point, flash point, relative vapour density, ozone depleting potential, and reactivity. Bioaccumulation, persistence, acute toxicity and chronic toxicity have been reviewed for substance impact on air, water, and soils. 23 refs., 6 tabs.

  20. Structural rationale for the recognition of arginine at P₃ in PEXEL motif containing proteins of Plasmodium falciparum by plasmepsin V.

    Science.gov (United States)

    Guruprasad, Lalitha; Tanneeru, Karunakar; Guruprasad, Kunchur

    2011-06-01

    The virulent form of malaria is caused by Plasmodium falciparum that infects red blood cells. In order to survive inside the host, the parasite remodels the infected erythrocytes by exporting more than 300 effector proteins outside the parasitophorous vacuole membrane into the cytosol. The main feature of all the export proteins is the presence of a pentapeptide sequence motif; RxLxE/Q/D. This sequence motif is hydrolysed between L-x and the proteins with the acetylated new N-terminus xE/Q/D are exported. The enzyme responsible for this hydrolysis is plasmepsin V which is one of the ten aspartic proteases in P. falciparum. In order to understand the structural rationale for the specificity of this protease towards cleavage of the above motif, we generated three-dimensional models of seven plasmepsins (I, V to X) for which experimental structures are not available and compared these along with the crystal structures of three P. falciparum plasmepsins (II to IV). The structure comparisons revealed the importance of Tyr13, Glu77 and Ala117 specific to plasmepsin V that facilitates the accommodation of arginine at P₃ in the RxLxE/Q/D motif. Our analysis correlates the structure-function relationship of plasmepsin V.

  1. POL-TAVI – Polish Registry of Transcatheter Aortic Valve Implantation – simple tool, great value, rationale and design

    Science.gov (United States)

    Wilczek, Krzysztof; Tobota, Zdzisław; Chodór, Piotr; Cieśla, Daniel; Jaźwiec, Tomasz; Banasiak, Waldemar; Stępińska, Janina; Kalarus, Zbigniew; Opolski, Grzegorz; Zembala, Marian

    2016-01-01

    Aortic stenosis (AS) is the most common valvular heart disease in adults in Europe and North America. Management of AS patients depends on accurate diagnosis of the cause and stage of the disease process: the first and definitive therapeutic choice for a growing number of elderly patients with symptomatic AS is surgical treatment. In patients not eligible for surgery, transcatheter aortic valve implantation (TAVI) constitutes a safe and effective alternative. As an innovative, costly method of treatment, it requires however careful monitoring of its course, documenting its early and long-term results, and assessment of its safety and medical-economic cost-effectiveness. A medical registry seems to be an excellent tool to perform such analysis. The aim of this paper is to present the design and rationale for creation of the first National Cardiac-Cardiac Surgical Registry of Percutaneous Aortic Valve Treatment POL-TAVI, to describe its genesis and to highlight its key assumptions and aims. Despite its recent beginnings, the POL-TAVI Registry has already demonstrated its value and usability in monitoring and assessment of TAVI procedures, leading to further improvement and development of this new method in Poland. It constitutes an important and valuable tool for patients, the medical community and the payer. PMID:28096826

  2. Establishing a Korean Language Programme in a European Higher Education Context: Rationale, Curriculum and Assessment Procedures

    Science.gov (United States)

    Carson, Lorna; Do, Eunjee

    2013-01-01

    A growth in interest in Korean contemporary culture in Europe has benefitted Korean language studies in Higher Education. This article describes an innovative Korean language programme in the School of Linguistic, Speech and Communication Sciences at Trinity College Dublin, Ireland. Since its establishment as a pilot project in 2010, the Korean…

  3. Dexmedetomidine for the treatment of alcohol withdrawal syndrome: rationale and current status of research.

    Science.gov (United States)

    Muzyk, Andrew J; Kerns, Suzanne; Brudney, Scott; Gagliardi, Jane P

    2013-11-01

    Dexmedetomidine is currently used in the US in the treatment of alcohol withdrawal syndrome (AWS) in the intensive care unit (ICU) setting, although data to support this practice are limited. Dexmedetomidine targets the noradrenergic system, an important but frequently overlooked secondary mechanism in the development of AWS, and, in doing so, may reduce the need for excessive benzodiazepine use which can increase the risk of γ-aminobutyric acid (GABA)-mediated deliriogenesis and respiratory depression. The purpose of this narrative review is to evaluate available literature reporting on the safety and efficacy of dexmedetomidine for AWS in the ICU setting. An English-language MEDLINE search (1966 to July 2013) was performed to identify articles evaluating the efficacy and safety of dexmedetomidine for AWS. Case series, case reports and controlled trials were evaluated for topic relevance and clinical applicability. Reference lists of articles retrieved through this search were reviewed to identify any relevant publications. Studies focusing on the safety and efficacy of dexmedetomidine for AWS in humans were selected. Studies were included if they were published as full articles; abstracts alone were not included in this review. Eight published case studies and case series were identified. Based on a limited body of evidence, dexmedetomidine shows promise as a potentially safe and possibly effective adjuvant treatment for AWS in the ICU. Prospective, well-controlled studies are needed to confirm the safety and efficacy of the use of dexmedetomidine in AWS.

  4. "Water Is Life"--Farmer Rationales and Water Saving in Khorezm, Uzbekistan: A Lifeworld Analysis

    Science.gov (United States)

    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…

  5. New regulations for medical devices: Rationale, advances and impact on research and patient care.

    Science.gov (United States)

    Labek, Gerold; Schöffl, Harald; Stoica, Christian Ioan

    2016-03-18

    A series of events relating to inferior medical devices has brought about changes in the legal requirements regarding quality control on the part of regulators. Apart from clinical studies, register and routine data will play an essential role in this context. To ensure adequate use of these data, adapted methodologies are required as register data in fact represent a new scientific entity. For the interpretation of register and routine data several limitations of published data should be taken into account. In many cases essential parameters of study cohorts - such as age, comorbidities, the patients' risk profiles or the hospital profile - are not presented. Required data and evaluation procedures differ significantly, for example, between hip and spine implants. A "one fits for all" methodology is quite unlikely to exist and vigorous efforts will be required to develop suitable standards in the next future. The new legislation will affect all high-risk products, besides joint implants also contact lenses, cardiac pacemakers or stents, for example, the new regulations can markedly enhance product quality monitoring. Register data and clinical studies should not be considered as competitors, they complement each other when used responsibly. In the future follow-up studies should increasingly focus on specific questions, while global follow-up investigations regarding product complication rates and surgical methods will increasingly be covered by registers.

  6. Connecting Agents and Artifacts in CSCL: Towards a Rationale of Mutual Shaping

    Science.gov (United States)

    Overdijk, Maarten; van Diggelen, Wouter; Kirschner, Paul A.; Baker, Michael

    2012-01-01

    Studying how collaborative activity takes shape interactionally in the context of technological settings is one of the main challenges in the field of Computer-Supported Collaborative Learning (CSCL). It requires us, amongst other things, to look into the "black box" of how technical artifacts are brought into use, or rather, how they are attuned…

  7. Rationale for Computer Ethics Policies and a Model Policy for the North Carolina Community College System.

    Science.gov (United States)

    DeLisse, Regina L.

    This study addresses new concerns of higher education organizational leaders as a result of the extended use of information technology on college campuses. Some of the most important and controversial issues include ethical and legal matters such as privacy, freedom of speech, intellectual property, and legislative attempts for Internet…

  8. Faculty Member Engagement in Canadian University Internationalization: A Consideration of Understanding, Motivations and Rationales

    Science.gov (United States)

    Friesen, Rhonda

    2013-01-01

    Faculty members are key agents in the institutional internationalization process within Canadian higher education. In the growing volumes of literature on internationalization, however, few authors consider how faculty members perceive their role in this process. In this study I take a phenomenological research approach to explore the…

  9. Is there a rationale for treatment of chronic liver disease with antithrombotic therapy?

    NARCIS (Netherlands)

    Hugenholtz, Greg C. G.; Northup, Patrick G.; Porte, Robert J.; Lisman, Ton

    2015-01-01

    Recent advances in the understanding of the coagulopathy in chronic liver disease have provided a strong support for anticoagulation as a new therapeutic paradigm for patients with cirrhosis. Laboratory studies indicate that the net effect of changes in hemostasis in many patients with chronic liver

  10. The rationale, development, and standardization of a basic word vocabulary test.

    Science.gov (United States)

    Dupuy, H J

    1974-04-01

    The results of the studies to date indicate that the Basic Word Vocabulary Test provides a range of items in terms of item difficulty levels useful in printed form from about the third grade to the highest educational levels. Since pictorial and orally given vocabulary tests are used from about ages 2 to 8 years, further work should be done to extend the scale downward so that a single comprehensive vocabulary scale ranging from age 2 years to the highest level of verbal development is available for general use. Validation studies should also be conducted with other well-known intelligence tests so that scores can be compared. Alternate forms need to be developed to allow for longitudinal studies of growth and development. The use of a single standard of measurement of vocabulary development, suitable over a wide range of age and ability levels, by different investigators should materially aid in comparing results across studies and samples and lead to more consistent findings, advances in knowledge, and wider application of findings in practical circumstances, The findings presented in this report indicate that the Basic Word Vocabulary Test adequately measures basic word knowledge acquisition and development. The BWVT is suitable for evaluation of individuals and for use in making group comparisons in levels of basic word knowledge attainment, growth, and development.

  11. "Water Is Life"--Farmer Rationales and Water Saving in Khorezm, Uzbekistan: A Lifeworld Analysis

    Science.gov (United States)

    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…

  12. Rationales for Support That African American Grandmothers Provide to Their Children Who Are Parenting Adolescents

    Science.gov (United States)

    Sumo, Jen'nea; Dancy, Barbara; Julion, Wrenetha; Wilbur, JoEllen

    2015-01-01

    African American grandmothers are known to be a major source of support for their children who are parenting adolescents, but little is known about why they provide support. The purpose of this study was to describe the kinds of support provided by African American maternal and paternal grandmothers to their parenting adolescents and the reasons…

  13. First-line antihypertensive treatment in patients with pre-diabetes: Rationale, design and baseline results of the ADaPT investigation

    Directory of Open Access Journals (Sweden)

    Bramlage Peter

    2008-07-01

    Full Text Available Abstract Background Recent clinical trials reported conflicting results on the reduction of new-onset diabetes using RAS blocking agents. Therefore the role of these agents in preventing diabetes is still not well defined. Ramipril is an ACE inhibitor (ACEi, that has been shown to reduce cardiovascular events in high risk patients and post-hoc analyses of the HOPE trial have provided evidence for its beneficial action in the prevention of diabetes. Methods The ADaPT investigation ("ACE inhibitor-based versus diuretic-based antihypertensive primary treatment in patients with pre-diabetes" is a 4-year open, prospective, parallel group phase IV study. It compares an antihypertensive treatment regimen based on ramipril versus a treatment based on diuretics or betablockers. The primary evaluation criterion is the first manifestation of type 2 diabetes. The study is conducted in primary care to allow the broadest possible application of its results. The present article provides an outline of the rationale, the design and baseline characteristics of AdaPT and compares these to previous studies including ASCOT-BLPA, VALUE and DREAM. Results Until March 2006 a total of 2,015 patients in 150 general practices (general physicians and internists throughout Germany were enrolled. The average age of patients enrolled was 67.1 ± 10.3 years, with 47% being male and a BMI of 29.9 ± 5.0 kg/m2. Dyslipidemia was present in 56.5%. 37.8% reported a family history of diabetes, 57.8% were previously diagnosed with hypertension (usually long standing. The HbA1c value at baseline was 5.6 %. Compared to the DREAM study patients were older, had more frequently hypertension and patients with cardiovascular disease were not excluded. Conclusion Comparing the ADaPT design and baseline data to previous randomized controlled trial it can be acknowledged that AdaPT included patients with a high risk for diabetes development. Results are expected to be available in 2010. Data

  14. Archaeology in Social Studies: An Integrated Approach. Theme: Archaeology in the Classroom.

    Science.gov (United States)

    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)

  15. Optimization of diagnostic imaging use in patients with acute abdominal pain (OPTIMA: Design and rationale

    Directory of Open Access Journals (Sweden)

    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.

  16. Viral infections and atopy in asthma pathogenesis: new rationales for asthma prevention and treatment.

    Science.gov (United States)

    Holt, Patrick G; Sly, Peter D

    2012-05-04

    Prospective birth cohort studies tracking asthma initiation and consolidation in community cohorts have identified viral infections occurring against a background of allergic sensitization to aeroallergens as a uniquely potent risk factor for the expression of acute severe asthma-like symptoms and for the ensuing development of asthma that can persist through childhood and into adulthood. A combination of recent experimental and human studies have suggested that underlying this bipartite process are a series of interactions between antiviral and atopic inflammatory pathways that are mediated by local activation of myeloid cell populations in the airway mucosa and the parallel programming and recruitment of their replacements from bone marrow. Targeting key components of these pathways at the appropriate stages of asthma provides new opportunities for the treatment of established asthma but, more crucially, for primary and secondary prevention of asthma during childhood.

  17. B-Cell Depletion Therapy in Systemic Sclerosis: Experimental Rationale and Update on Clinical Evidence

    Directory of Open Access Journals (Sweden)

    Dimitrios Daoussis

    2011-01-01

    Full Text Available Systemic sclerosis (SSc is a systemic rheumatic disease with poor prognosis since therapeutic options are limited. Recent evidence from animal models suggests that B-cells may be actively involved in the fibrotic process. B-cells from tight skin mice, an animal model of scleroderma, display a “hyperresponsive” phenotype; treatment with rituximab (RTX significantly attenuates skin fibrosis in this animal model. In humans, B-cell infiltration is a prominent finding in most lung biopsies obtained from patients with SSc-associated interstitial lung disease. Several open label studies have assessed the clinical efficacy of RTX in SSc. In most patients skin fibrosis improved; lung function either improved or remained stable. Definite conclusions regarding the clinical efficacy of RTX in SSc cannot be drawn but further exploration with a multicenter, randomized study is warranted.

  18. International Financial Reporting Standard’s (IFRS Adoption in Ghana: Rationale, Benefits and Challenges

    Directory of Open Access Journals (Sweden)

    Adwoa Acheampomaa Boateng

    2014-10-01

    Full Text Available The International Financial Reporting Standards (IFRS was adopted by Ghana in 2007. The study assessed eighteen (18 professional accountants from listed firms on the Ghana Stock Exchange (GSE, to measure the benefits and challenges of IFRS. The study revealed that IFRS improved the access of local companies to international markets. It was also observed that the local firms gained more credibility, transparency, acceptance and consolidation following its adoption. However, most respondents believed that decreasing information cost, competitive leading edge, and integration of accounting Information Technology system were not major benefits as proposed by literature. Nonetheless, some of these local companies after the migration faced challenges like coping with the sophistication of the new standard, lack of qualified personnel, and additional operational cost. Nevertheless, most of the respondents disagreed with the proposition that IFRS had a negative impact on their firms’ balance of retained earnings.

  19. Perioperative rehabilitation in operation for lung cancer (PROLUCA) – rationale and design

    DEFF Research Database (Denmark)

    Sommer, Maja S; Trier, Karen; Vibe-Petersen, Jette

    2014-01-01

    BACKGROUND: The purpose of the PROLUCA study is to investigate the efficacy of preoperative and early postoperative rehabilitation in a non-hospital setting in patients with operable lung cancer with special focus on exercise. METHODS: Using a 2x2 factorial design with continuous effect endpoint...... study may potentially contribute to the identification of the optimal perioperative rehabilitation for operable lung cancer patients focusing on exercise initiated immediately after diagnosis and rehabilitation shortly after surgery. TRIAL REGISTRATION: NCT01893580....... (Maximal Oxygen Uptake (VO2peak)), 380 patients with non-small cell lung cancer (NSCLC) stage I-IIIa referred for surgical resection will be randomly assigned to one of four groups: (1) preoperative and early postoperative rehabilitation (starting two weeks after surgery); (2) preoperative and late...

  20. Rationale for determining the types of adaptation to predict in sport

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    Anatoliy Rovnyy

    2015-10-01

    Full Text Available Purpose: theoretical and practical study adaptation types beginners. Materials and Methods: an analytical synthesis of scientific literature data, the determination of the concentration of lactic acid testing of motor activity. Results: based on the parameters set lactate types of adaptation: «sprinters», «stayers», «mixed type». Conclusions: the establishment of types of adaptation makes it possible to recommend a special focus budding athletes in the sport