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Sample records for achieved clinical benefit

  1. Achieving the Benefits of Safeguards by Design

    SciTech Connect

    Trond Bjornard; Robert Bean; David Hebditch; Jim Morgan; Bruce Meppen; Scott DeMuth; Michael Ehinger; John Hockert

    2008-07-01

    The overarching driver for developing a formalized process to achieve safeguards by design is to support the global growth of nuclear power while reducing ‘nuclear security’ risks. This paper discusses an institutional approach to the design process for a nuclear facility, for designing proliferation resistance, international safeguards and U.S. national safeguards and security into new nuclear facilities. In the United States, the need exists to develop a simple, concise, formalized, and integrated approach for incorporating international safeguards and other non-proliferation considerations into the facility design process. An effective and efficient design process is one which clearly defines the functional requirements at the beginning of the project and provides for the execution of the project to achieve a reasonable balance among competing objectives in a cost effective manner. Safeguards by Design is defined as “the integration of international and national safeguards, physical security and non-proliferation features as full and equal partners in the design process of a nuclear energy system or facility,” with the objective to achieve facilities that are intrinsically more robust while being less expensive to safeguard and protect. This Safeguards by Design process has been developed such that it: • Provides improved safeguards, security, and stronger proliferation barriers, while reducing the life cycle costs to the operator and regulatory agencies, • Can be translated to any international context as a model for nuclear facility design, • Fosters a culture change to ensure the treatment of ‘nuclear security’ considerations as “full and equal” partners in the design process, • Provides a useful tool for the project manager responsible for the design, construction, and start-up of nuclear facilities, and • Addresses the key integration activities necessary to efficiently incorporate International Atomic Energy Agency safeguards into

  2. Bilingual Two-Way Immersion Programs Benefit Academic Achievement

    ERIC Educational Resources Information Center

    Marian, Viorica; Shook, Anthony; Schroeder, Scott R.

    2013-01-01

    The effects of bilingual education on reading and math achievement were examined by comparing test scores across different elementary school programs. Results revealed that bilingual Two-Way Immersion (TWI) programs benefited both minority-language and majority-language students. Minority-language students in TWI programs outperformed their peers…

  3. Benefits of dietary fiber in clinical nutrition.

    PubMed

    Klosterbuer, Abby; Roughead, Zamzam Fariba; Slavin, Joanne

    2011-10-01

    Dietary fiber is widely recognized as an important part of a healthy diet and is a common addition to enteral nutrition (EN) formulas. Fiber sources differ in characteristics such as solubility, fermentability, and viscosity, and it is now well known that different types of fiber exert varying physiological effects in the body. Clinical studies suggest fiber can exert a wide range of benefits in areas such as bowel function, gut health, immunity, blood glucose control, and serum lipid levels. Although early clinical nutrition products contained fiber from a single source, it is now thought that blends of fiber from multiple sources more closely resemble a regular diet and may provide a greater range of benefits for the patient. Current recommendations support the use of dietary fiber in clinical nutrition when no contraindications exist, but little information exists about which types and combinations of fibers provide the relevant benefit in certain patient populations. This article summarizes the different types of fiber commonly added to EN products and reviews the current literature on the use of fiber blends in clinical nutrition.

  4. Critical Evidence: How the Arts Benefit Student Achievement

    ERIC Educational Resources Information Center

    Ruppert, Sandra S.

    2006-01-01

    Why is it so important to keep the arts strong in schools? How does study of the arts contribute to student achievement and success? This paper is designed to answer these and other questions. It describes in nontechnical terms what the research says about how study of the arts contributes to academic achievement and student success. It offers…

  5. Intimate Behavior and Assessment of Benefits in Clinical Groups.

    ERIC Educational Resources Information Center

    Shadish, William R., Jr.

    1984-01-01

    Developed three measures of clinical group benefits and presented empirical evidence (N=27) explicating the logic of the Interpersonal Relations Scale as an assessment device. Conceptualized the benefits of clinical groups as the fostering of intimacy skills by which group members learn about themselves, others, and their interpersonal…

  6. Shifting the Bell Curve: The Benefits and Costs of Raising Student Achievement

    ERIC Educational Resources Information Center

    Yeh, Stuart S.

    2009-01-01

    Benefit-cost analysis was conducted to estimate the increase in earnings, increased tax revenues, value of less crime, and reductions in welfare costs attributable to nationwide implementation of rapid assessment, a promising intervention for raising student achievement in math and reading. Results suggest that social benefits would exceed total…

  7. Application of the CIT concept in the clinical environment: hurdles, practicalities, and clinical benefits.

    PubMed

    Sterr, Annette; Szameitat, Andre; Shen, Shan; Freivogel, Susanna

    2006-03-01

    Basic neuroscience research on brain plasticity, motor learning, and recovery has stimulated new concepts in motor rehabilitation. Combined with the development of methodological goal standards in clinical outcome research, these findings have effectuated the introduction of a double-paradigm shift in physical rehabilitation: (a) the move toward evidence-based procedures and disablement models for the assessment of clinical outcome and (b) the introduction of training-based concepts that are theoretically founded in learning theory. A major drive for new interventions has further come from recent findings on the adaptive capacities of neural networks and their linkage to perception, performance, and long-term recovery. In this context, constraint-induced movement therapy, an intervention initially designed for upper-limb hemiparesis, represents the theoretically and empirically most thoroughly founded training concept. Several clinical trials on constraint-induced therapy (CIT) have shown its efficacy in higher functioning patients; however, the transfer of the treatment into standard health care seems slow. Survey research further suggests a rather poor acceptance of CIT among clinical staff and it seems that the implementation of CIT is hindered by barriers constructed of beliefs and assumptions that demand a critical and evidence-based discussion. Within this context, we have conducted a series of experiments on amended CIT protocols and their application in the clinical environment which addressed the following issues: (1) massed practice: are 6 hours of daily training inevitable to achieve clinical benefits? (2) practicality: what is feasible in the standard care setting and what are the clinical benefits achieved by "feasible compromise CIT protocols?" (3) apprehensions: are concerns on increased muscular tone and pathologic movement patterns justified, and (4) learned nonuse: is the assumption of "hidden" residual abilities valid so that it warrants the

  8. Clinical benefits of metformin in gynecologic oncology

    PubMed Central

    IMAI, ATSUSHI; ICHIGO, SATOSHI; MATSUNAMI, KAZUTOSHI; TAKAGI, HIROSHI; YASUDA, KEIGO

    2015-01-01

    Evidence has suggested that diabetes may contribute to the initiation and progression of specific types of cancer. Metformin, a biguanide, has become the preferred first-line therapy for the treatment of type 2 diabetes. Metformin is inexpensive, has a proven safety profile and is able to be safely combined with additional antidiabetic agents. In addition to the well-established antidiabetic effects of metformin, there has also been notable interest in its antitumor properties. The present review discusses the emerging role of metformin as an example of an existing drug, used worldwide in the treatment of diabetes, which has been demonstrated to exert significant in vitro and in vivo anticancer activities and has thus been investigated in clinical trials. In gynecologic oncology, metformin has been suggested to exhibit significant treatment efficacy against endometrial cancer. Three studies have demonstrated the potential therapeutic effects of metformin on the survival outcome of patients with ovarian cancer and in ovarian cancer prevention. However, this evidence was based on observational studies. Metformin has been shown to exert no statistically significant beneficial effect on cervical cancer incidence or mortality. By cancer site, the current limited insights highlight the need for clinical investigations and better-designed studies, along with evaluation of the effects of metformin on cancer at other sites. PMID:26622536

  9. Clinically Relevant Physical Benefits of Exercise Interventions in Breast Cancer Survivors.

    PubMed

    Kirkham, Amy A; Bland, Kelcey A; Sayyari, Sarah; Campbell, Kristin L; Davis, Margot K

    2016-02-01

    Evidence is currently limited for the effect of exercise on breast cancer clinical outcomes. However, several of the reported physical benefits of exercise, including peak oxygen consumption, functional capacity, muscle strength and lean mass, cardiovascular risk factors, and bone health, have established associations with disability, cardiovascular disease risk, morbidity, and mortality. This review will summarize the clinically relevant physical benefits of exercise interventions in breast cancer survivors and discuss recommendations for achieving these benefits. It will also describe potential differences in intervention delivery that may impact outcomes and, lastly, describe current physical activity guidelines for cancer survivors. PMID:26769117

  10. Disruption, Achievement and the Heterogeneous Benefits of Smaller Classes. NBER Working Paper No. 15812

    ERIC Educational Resources Information Center

    McKee, Graham J.; Rivkin, Steven G.; Sims, Katharine R. E.

    2010-01-01

    With few exceptions, empirical research investigating the possibility of heterogeneous benefits of class size reduction lacks a conceptual framework about specific dimensions of potential heterogeneity. In this paper we develop a model of education production that incorporates disruption and student achievement and illustrates how these underlying…

  11. Variability in Clinical Integration Achieved by Athletic Training Students across Different Clinical Sport Assignments

    ERIC Educational Resources Information Center

    Dodge, Thomas M.; Mazerolle, Stephanie M.; Bowman, Thomas G.

    2015-01-01

    Context: Clinical integration impacts athletic training students' (ATSs) motivation and persistence. Research has yet to elucidate the manner in which different clinical placements can influence clinical integration. Objective: To examine differences in the levels of clinical integration achieved by ATSs across various clinical sport assignments.…

  12. Achieving the World Health Organization's vision for clinical pharmacology.

    PubMed

    Martin, Jennifer H; Henry, David; Gray, Jean; Day, Richard; Bochner, Felix; Ferro, Albert; Pirmohamed, Munir; Mörike, Klaus; Schwab, Matthias

    2016-02-01

    Clinical pharmacology is a medical specialty whose practitioners teach, undertake research, frame policy, give information and advice about the actions and proper uses of medicines in humans and implement that knowledge in clinical practice. It involves a combination of several activities: drug discovery and development, training safe prescribers, providing objective and evidence-based therapeutic information to ethics, regulatory and pricing bodies, supporting patient care in an increasingly subspecialized arena where co-morbidities, polypharmacy, altered pharmacokinetics and drug interactions are common and developing and contributing to medicines policies for Governments. Clinical pharmacologists must advocate drug quality and they must also advocate for sustainability of the Discipline. However for this they need appropriate clinical service and training support. This Commentary discusses strategies to ensure the Discipline is supported by teaching, training and policy organizations, to communicate the full benefits of clinical pharmacology services, put a monetary value on clinical pharmacology services and to grow the clinical pharmacology workforce to support a growing clinical, academic and regulatory need. PMID:26466826

  13. How Does the Patient Benefit from Clinical PET?

    PubMed Central

    Sörensen, Jens

    2012-01-01

    Clinical molecular imaging by use of PET and PET/CT is increasingly important in routine oncological practice worldwide. A vast majority of clinical PET investigations are performed with [18F]-fluorodeoxyglucose (FDG), but there is a growing interest in novel molecular probes among scientists and clinicians. Beyond FDG, a small number of different tracers have been shown to be of clinical value. With a growing commercial interest in tracer development, many more are under investigation. This review provides some examples of clinical situations where tracers other than FDG have been found useful and an outlook towards technical and regulatory development needed to allow the full impact of clinical PET to benefit the individual patient. PMID:22768023

  14. Component Prioritization Schema for Achieving Maximum Time and Cost Benefits from Software Testing

    NASA Astrophysics Data System (ADS)

    Srivastava, Praveen Ranjan; Pareek, Deepak

    Software testing is any activity aimed at evaluating an attribute or capability of a program or system and determining that it meets its required results. Defining the end of software testing represents crucial features of any software development project. A premature release will involve risks like undetected bugs, cost of fixing faults later, and discontented customers. Any software organization would want to achieve maximum possible benefits from software testing with minimum resources. Testing time and cost need to be optimized for achieving a competitive edge in the market. In this paper, we propose a schema, called the Component Prioritization Schema (CPS), to achieve an effective and uniform prioritization of the software components. This schema serves as an extension to the Non Homogenous Poisson Process based Cumulative Priority Model. We also introduce an approach for handling time-intensive versus cost-intensive projects.

  15. Improving International Research with Clinical Specimens: 5 Achievable Objectives

    PubMed Central

    LaBaer, Joshua

    2012-01-01

    Our increased interest in translational research has created a large demand for blood, tissue and other clinical samples, which find use in a broad variety of research including genomics, proteomics, and metabolomics. Hundreds of millions of dollars have been invested internationally on the collection, storage and distribution of samples. Nevertheless, many researchers complain in frustration about their inability to obtain relevant and/or useful samples for their research. Lack of access to samples, poor condition of samples, and unavailability of appropriate control samples have slowed our progress in the study of diseases and biomarkers. In this editorial, I focus on five major challenges that thwart clinical sample use for translational research and propose near term objectives to address them. They include: (1) defining our biobanking needs; (2) increasing the use of and access to standard operating procedures; (3) mapping inter-observer differences for use in normalizing diagnoses; (4) identifying natural internal protein controls; and (5) redefining the clinical sample paradigm by building partnerships with the public. In each case, I believe that we have the tools at hand required to achieve the objective within 5 years. Potential paths to achieve these objectives are explored. However we solve these problems, the future of proteomics depends on access to high quality clinical samples, collected under standardized conditions, accurately annotated and shared under conditions that promote the research we need to do. PMID:22998582

  16. The World Already Avoided: Quantifying the Ozone Benefits Achieved by the Montreal Protocol

    NASA Astrophysics Data System (ADS)

    Chipperfield, Martyn; Dhomse, Sandip; Feng, Wuhu; McKenzie, Richard; Velders, Guus; Pyle, John

    2015-04-01

    Chlorine and bromine-containing ozone-depleting substances (ODSs) are controlled by the 1987 Montreal Protocol. In consequence, atmospheric equivalent chlorine peaked in 1993 and has been declining slowly since then. Consistent with this, models project a gradual increase in stratospheric ozone with the Antarctic Ozone Hole expected to disappear by ~2050. However, we show that by 2014 the Montreal Protocol has already achieved significant benefits for the ozone layer. Using an off-line 3-D atmospheric chemistry model, we demonstrate that much larger ozone depletion than observed has been avoided by the protocol, with benefits for surface UV and climate. A deep Arctic Ozone Hole, with column values <120 DU, would have occurred given the meteorological conditions in 2011. The Antarctic Ozone Hole would have grown in size by 40% by 2013, with enhanced loss at subpolar latitudes. The ozone decline over northern hemisphere middle latitudes would have continued, more than doubling to ~15% by 2013.

  17. Different clinical electrodes achieve similar electrical nerve conduction block

    NASA Astrophysics Data System (ADS)

    Boger, Adam; Bhadra, Narendra; Gustafson, Kenneth J.

    2013-10-01

    Objective. We aim to evaluate the suitability of four electrodes previously used in clinical experiments for peripheral nerve electrical block applications. Approach. We evaluated peripheral nerve electrical block using three such clinical nerve cuff electrodes (the Huntington helix, the Case self-sizing Spiral and the flat interface nerve electrode) and one clinical intramuscular electrode (the Memberg electrode) in five cats. Amplitude thresholds for the block using 12 or 25 kHz voltage-controlled stimulation, onset response, and stimulation thresholds before and after block testing were determined. Main results. Complete nerve block was achieved reliably and the onset response to blocking stimulation was similar for all electrodes. Amplitude thresholds for the block were lowest for the Case Spiral electrode (4 ± 1 Vpp) and lower for the nerve cuff electrodes (7 ± 3 Vpp) than for the intramuscular electrode (26 ± 10 Vpp). A minor elevation in stimulation threshold and reduction in stimulus-evoked urethral pressure was observed during testing, but the effect was temporary and did not vary between electrodes. Significance. Multiple clinical electrodes appear suitable for neuroprostheses using peripheral nerve electrical block. The freedom to choose electrodes based on secondary criteria such as ease of implantation or cost should ease translation of electrical nerve block to clinical practice.

  18. Identification of Synergistic, Clinically Achievable, Combination Therapies for Osteosarcoma

    PubMed Central

    Yu, Diana; Kahen, Elliot; Cubitt, Christopher L.; McGuire, Jeremy; Kreahling, Jenny; Lee, Jae; Altiok, Soner; Lynch, Conor C.; Sullivan, Daniel M.; Reed, Damon R.

    2015-01-01

    Systemic therapy has improved osteosarcoma event-free and overall survival, but 30–50% of patients originally diagnosed will have progressive or recurrent disease, which is difficult to cure. Osteosarcoma has a complex karyotype, with loss of p53 in the vast majority of cases and an absence of recurrent, targetable pathways. In this study, we explored 54 agents that are clinically approved for other oncologic indications, agents in active clinical development, and others with promising preclinical data in osteosarcoma at clinically achievable concentrations in 5 osteosarcoma cell lines. We found significant single-agent activity of multiple agents and tested 10 drugs in all permutations of two-drug combinations to define synergistic combinations by Chou and Talalay analysis. We then evaluated order of addition to choose the combinations that may be best to translate to the clinic. We conclude that the repurposing of chemotherapeutics in osteosarcoma by using an in vitro system may define novel drug combinations with significant in vivo activity. In particular, combinations of proteasome inhibitors with histone deacetylase inhibitors and ixabepilone and MK1775 demonstrated excellent activity in our assays. PMID:26601688

  19. Identification of Synergistic, Clinically Achievable, Combination Therapies for Osteosarcoma.

    PubMed

    Yu, Diana; Kahen, Elliot; Cubitt, Christopher L; McGuire, Jeremy; Kreahling, Jenny; Lee, Jae; Altiok, Soner; Lynch, Conor C; Sullivan, Daniel M; Reed, Damon R

    2015-01-01

    Systemic therapy has improved osteosarcoma event-free and overall survival, but 30-50% of patients originally diagnosed will have progressive or recurrent disease, which is difficult to cure. Osteosarcoma has a complex karyotype, with loss of p53 in the vast majority of cases and an absence of recurrent, targetable pathways. In this study, we explored 54 agents that are clinically approved for other oncologic indications, agents in active clinical development, and others with promising preclinical data in osteosarcoma at clinically achievable concentrations in 5 osteosarcoma cell lines. We found significant single-agent activity of multiple agents and tested 10 drugs in all permutations of two-drug combinations to define synergistic combinations by Chou and Talalay analysis. We then evaluated order of addition to choose the combinations that may be best to translate to the clinic. We conclude that the repurposing of chemotherapeutics in osteosarcoma by using an in vitro system may define novel drug combinations with significant in vivo activity. In particular, combinations of proteasome inhibitors with histone deacetylase inhibitors and ixabepilone and MK1775 demonstrated excellent activity in our assays. PMID:26601688

  20. Quantifying the ozone and ultraviolet benefits already achieved by the Montreal Protocol.

    PubMed

    Chipperfield, M P; Dhomse, S S; Feng, W; McKenzie, R L; Velders, G J M; Pyle, J A

    2015-01-01

    Chlorine- and bromine-containing ozone-depleting substances (ODSs) are controlled by the 1987 Montreal Protocol. In consequence, atmospheric equivalent chlorine peaked in 1993 and has been declining slowly since then. Consistent with this, models project a gradual increase in stratospheric ozone with the Antarctic ozone hole expected to disappear by ∼2050. However, we show that by 2013 the Montreal Protocol had already achieved significant benefits for the ozone layer. Using a 3D atmospheric chemistry transport model, we demonstrate that much larger ozone depletion than observed has been avoided by the protocol, with beneficial impacts on surface ultraviolet. A deep Arctic ozone hole, with column values <120 DU, would have occurred given meteorological conditions in 2011. The Antarctic ozone hole would have grown in size by 40% by 2013, with enhanced loss at subpolar latitudes. The decline over northern hemisphere middle latitudes would have continued, more than doubling to ∼15% by 2013. PMID:26011106

  1. Quantifying the ozone and ultraviolet benefits already achieved by the Montreal Protocol

    NASA Astrophysics Data System (ADS)

    Chipperfield, M. P.; Dhomse, S. S.; Feng, W.; McKenzie, R. L.; Velders, G. J. M.; Pyle, J. A.

    2015-05-01

    Chlorine- and bromine-containing ozone-depleting substances (ODSs) are controlled by the 1987 Montreal Protocol. In consequence, atmospheric equivalent chlorine peaked in 1993 and has been declining slowly since then. Consistent with this, models project a gradual increase in stratospheric ozone with the Antarctic ozone hole expected to disappear by ~2050. However, we show that by 2013 the Montreal Protocol had already achieved significant benefits for the ozone layer. Using a 3D atmospheric chemistry transport model, we demonstrate that much larger ozone depletion than observed has been avoided by the protocol, with beneficial impacts on surface ultraviolet. A deep Arctic ozone hole, with column values <120 DU, would have occurred given meteorological conditions in 2011. The Antarctic ozone hole would have grown in size by 40% by 2013, with enhanced loss at subpolar latitudes. The decline over northern hemisphere middle latitudes would have continued, more than doubling to ~15% by 2013.

  2. Quantifying the ozone and ultraviolet benefits already achieved by the Montreal Protocol.

    PubMed

    Chipperfield, M P; Dhomse, S S; Feng, W; McKenzie, R L; Velders, G J M; Pyle, J A

    2015-05-26

    Chlorine- and bromine-containing ozone-depleting substances (ODSs) are controlled by the 1987 Montreal Protocol. In consequence, atmospheric equivalent chlorine peaked in 1993 and has been declining slowly since then. Consistent with this, models project a gradual increase in stratospheric ozone with the Antarctic ozone hole expected to disappear by ∼2050. However, we show that by 2013 the Montreal Protocol had already achieved significant benefits for the ozone layer. Using a 3D atmospheric chemistry transport model, we demonstrate that much larger ozone depletion than observed has been avoided by the protocol, with beneficial impacts on surface ultraviolet. A deep Arctic ozone hole, with column values <120 DU, would have occurred given meteorological conditions in 2011. The Antarctic ozone hole would have grown in size by 40% by 2013, with enhanced loss at subpolar latitudes. The decline over northern hemisphere middle latitudes would have continued, more than doubling to ∼15% by 2013.

  3. Quantifying the ozone and ultraviolet benefits already achieved by the Montreal Protocol

    PubMed Central

    Chipperfield, M. P.; Dhomse, S. S.; Feng, W.; McKenzie, R. L.; Velders, G.J.M.; Pyle, J. A.

    2015-01-01

    Chlorine- and bromine-containing ozone-depleting substances (ODSs) are controlled by the 1987 Montreal Protocol. In consequence, atmospheric equivalent chlorine peaked in 1993 and has been declining slowly since then. Consistent with this, models project a gradual increase in stratospheric ozone with the Antarctic ozone hole expected to disappear by ∼2050. However, we show that by 2013 the Montreal Protocol had already achieved significant benefits for the ozone layer. Using a 3D atmospheric chemistry transport model, we demonstrate that much larger ozone depletion than observed has been avoided by the protocol, with beneficial impacts on surface ultraviolet. A deep Arctic ozone hole, with column values <120 DU, would have occurred given meteorological conditions in 2011. The Antarctic ozone hole would have grown in size by 40% by 2013, with enhanced loss at subpolar latitudes. The decline over northern hemisphere middle latitudes would have continued, more than doubling to ∼15% by 2013. PMID:26011106

  4. Polyandrous females benefit by producing sons that achieve high reproductive success in a competitive environment.

    PubMed

    Firman, Renée C

    2011-09-22

    Females of many taxa often copulate with multiple males and incite sperm competition. On the premise that males of high genetic quality are more successful in sperm competition, it has been suggested that females may benefit from polyandry by accruing 'good genes' for their offspring. Laboratory studies have shown that multiple mating can increase female fitness through enhanced embryo viability, and have exposed how polyandry influences the evolution of the ejaculate. However, such studies often do not allow for both female mate choice and male-male competition to operate simultaneously. Here, I took house mice (Mus domesticus) from selection lines that had been evolving with (polygamous) and without (monogamous) sperm competition for 16 generations and, by placing them in free-ranging enclosures for 11 weeks, forced them to compete for access to resources and mates. Parentage analyses revealed that female reproductive success was not influenced by selection history, but there was a significant paternity bias towards males from the polygamous selection lines. Therefore, I show that female house mice benefit from polyandry by producing sons that achieve increased fitness in a semi-natural environment.

  5. Realising the Real Benefits of Outsourcing: Measurement Excellence and Its Importance in Achieving Long Term Value

    NASA Astrophysics Data System (ADS)

    Oshri, Ilan; Kotlarsky, Julia

    These days firms are, more than ever, pressed to demonstrate returns on their investment in outsourcing. While the initial returns can always be associated with one-off cost cutting, outsourcing arrangements are complex, often involving inter-related high-value activities, which makes the realisation of long-term benefits from outsourcing ever more challenging. Executives in client firms are no longer satisfied with the same level of service delivery through the outsourcing lifecycle. They seek to achieve business transformation and innovation in their present and future services, beyond satisfying service level agreements (SLAs). Clearly the business world is facing a new challenge: an outsourcing delivery system of high-value activities that demonstrates value over time and across business functions. However, despite such expectations, many client firms are in the dark when trying to measure and quantify the return on outsourcing investments: results of this research show that less than half of all CIOs and CFOs (43%) have attempted to calculate the financial impact of outsourcing to their bottom line, indicating that the financial benefits are difficult to quantify (51%).

  6. Benefits and Challenges of Achieving a Mainstream Market for Electric Vehicles

    SciTech Connect

    Ungar, Edward; Mueller, Howard; Smith, Brett

    2010-08-01

    The Plug-in Hybrid electric Vehicle (PHEV) Market Introduction Study Final Report identified a range of policies, incentives and regulations designed to enhance the probability of success in commercializing PHEVs as they enter the automotive marketplace starting in 2010. The objective of the comprehensive PHEV Value Proposition study, which encompasses the PHEV Market Introduction Study, is to better understand the value proposition that PHEVs (as well as other plug-in electric vehicle platforms - PEVs) provide to the auto companies themselves, to the consumer and to the public at large as represented by the government and its public policies. In this report we use the more inclusive term PEVs, to include PHEVs, BEVs (battery electric vehicles that operate only on battery) and EREVs (extended range electric vehicles that combine battery electric vehicles with an internal combustion engine that charges the battery as needed). The objective of Taratec's contribution to Phase 2 of the PHEV Value Proposition Study is to develop a clear understanding of the benefits of PEVs to three stakeholders - auto original equipment manufacturers (OEMs), utilities, and the government - and of the technical and commercial challenges and risks to be overcome in order to achieve commercial success for these vehicles. The goal is to understand the technical and commercial challenges in moving from the 'early adopters' at the point of market introduction of these vehicles to a 'sustainable' mainstream market in which PEVs and other PEVs represent a normal, commercially available and attractive vehicle to the mainstream consumer. For the purpose of this study, that sustainable market is assumed to be in place in the 2030 timeframe. The principal focus of the study is to better understand the technical and commercial challenges in the transition from early adopters to a sustainable mainstream consumer market. Effectively, that translates to understanding the challenges to be overcome

  7. Clinical importance of achieving biochemical control with medical therapy in adult patients with acromegaly.

    PubMed

    Christofides, Elena A

    2016-01-01

    In acromegaly, achieving biochemical control (growth hormone [GH] level <1.0 ng/mL and age- and sex-normalized levels of insulin-like growth factor 1 [IGF-1]) through timely diagnosis and appropriate treatment provides an opportunity to improve patient outcomes. Diagnosis of acromegaly is challenging because it is rooted in observing subtle clinical manifestations, and it is typical for acromegaly to evolve for up to 10 years before it is recognized. This results in chronic exposure to elevated levels of GH and IGF-1 and delay in patients receiving appropriate treatment, which consequently increases mortality risk. In this review, the clinical impact of elevated GH and IGF-1 levels, the effectiveness of current therapies, and the potential role of novel treatments for acromegaly will be discussed. Clinical burden of acromegaly and benefits associated with management of GH and IGF-1 levels will be reviewed. Major treatment paradigms in acromegaly include surgery, medical therapy, and radiotherapy. With medical therapies, such as somatostatin analogs, dopamine agonists, and GH receptor antagonists, a substantial proportion of patients achieve reduced GH and normalized IGF-1 levels. In addition, signs and symptoms, quality of life, and comorbidities have also been reported to improve to varying degrees in patients who achieve biochemical control. Currently, there are several innovative therapies in development to improve patient outcomes, patient use, and access. Timely biochemical control of acromegaly ensures that the patient can ultimately improve morbidity and mortality from this disease and its extensive consequences. PMID:27471378

  8. Clinical importance of achieving biochemical control with medical therapy in adult patients with acromegaly

    PubMed Central

    Christofides, Elena A

    2016-01-01

    In acromegaly, achieving biochemical control (growth hormone [GH] level <1.0 ng/mL and age- and sex-normalized levels of insulin-like growth factor 1 [IGF-1]) through timely diagnosis and appropriate treatment provides an opportunity to improve patient outcomes. Diagnosis of acromegaly is challenging because it is rooted in observing subtle clinical manifestations, and it is typical for acromegaly to evolve for up to 10 years before it is recognized. This results in chronic exposure to elevated levels of GH and IGF-1 and delay in patients receiving appropriate treatment, which consequently increases mortality risk. In this review, the clinical impact of elevated GH and IGF-1 levels, the effectiveness of current therapies, and the potential role of novel treatments for acromegaly will be discussed. Clinical burden of acromegaly and benefits associated with management of GH and IGF-1 levels will be reviewed. Major treatment paradigms in acromegaly include surgery, medical therapy, and radiotherapy. With medical therapies, such as somatostatin analogs, dopamine agonists, and GH receptor antagonists, a substantial proportion of patients achieve reduced GH and normalized IGF-1 levels. In addition, signs and symptoms, quality of life, and comorbidities have also been reported to improve to varying degrees in patients who achieve biochemical control. Currently, there are several innovative therapies in development to improve patient outcomes, patient use, and access. Timely biochemical control of acromegaly ensures that the patient can ultimately improve morbidity and mortality from this disease and its extensive consequences. PMID:27471378

  9. Clinical imaging guidelines part 2: Risks, benefits, barriers, and solutions.

    PubMed

    Malone, James; del Rosario-Perez, Maria; Van Bladel, Lodewijk; Jung, Seung Eun; Holmberg, Ola; Bettmann, Michael A

    2015-02-01

    A recent international meeting was convened by two United Nations bodies to focus on international collaboration on clinical appropriateness/referral guidelines for use in medical imaging. This paper, the second of 4 from this technical meeting, addresses barriers to the successful development/deployment of clinical imaging guidelines and means of overcoming them. It reflects the discussions of the attendees, and the issues identified are treated under 7 headings: ■ Practical Strategy for Development and Deployment of Guidelines; ■ Governance Arrangements and Concerns with Deployment of Guidelines; ■ Finance, Sustainability, Reimbursement, and Related Issues; ■ Identifying Benefits and Radiation Risks from Radiological Examinations; ■ Information Given to Patients and the Public, and Consent Issues; ■ Special Concerns Related to Pregnancy; and ■ The Research Agenda. Examples of topics identified include the observation that guideline development is a global task and there is no case for continuing it as the project of the few professional organizations that have been brave enough to make the long-term commitment required. Advocacy for guidelines should include the expectations that they will facilitate: (1) better health care delivery; (2) lower cost of that delivery; with (3) reduced radiation dose and associated health risks. Radiation protection issues should not be isolated; rather, they should be integrated with the overall health care picture. The type of dose/radiation risk information to be provided with guidelines should include the uncertainty involved and advice on application of the precautionary principle with patients. This principle may be taken as an extension of the well-established medical principle of "first do no harm." PMID:25652302

  10. Challenges in Measuring Benefit of Clinical Research Training Programs--the ASH Clinical Research Training Institute Example.

    PubMed

    Sung, Lillian; Crowther, Mark; Byrd, John; Gitlin, Scott D; Basso, Joe; Burns, Linda

    2015-12-01

    The American Society of Hematology developed the Clinical Research Training Institute (CRTI) to address the lack of training in patient-oriented research among hematologists. As the program continues, we need to consider metrics for measuring the benefits of such a training program. This article addresses the benefits of clinical research training programs. The fundamental and key components are education and mentorship. However, there are several other benefits including promotion of collaboration, job and advancement opportunities, and promotion of work-life balance. The benefits of clinical research training programs need to be measured so that funders and society can judge if they are worth the investment in time and resources. Identification of elements that are important to program benefit is essential to measuring the benefit of the program as well as program planning. Future work should focus on the constructs which contribute to benefits of clinical research training programs such as CRTI.

  11. Exploring and Understanding the Benefits of Tutoring Software on Urban Students' Science Achievement: What Are Baltimore City Practitioners' Perspectives?

    ERIC Educational Resources Information Center

    Pinder, Patrice Juliet

    2008-01-01

    Historically, very little research that meets the scientifically based standards as defined by the No Child Left Behind Act has been conducted on the effectiveness of educational technology on student achievement. The purpose of this study was to explore and seek to understand urban city teachers' perspectives on the benefits or effects of…

  12. Intelligence and Academic Achievement in a Clinical Adolescent Population

    ERIC Educational Resources Information Center

    Stewart, David W.; Morris, Linda

    1977-01-01

    The present study was undertaken with two related goals: (a) to examine the relationships between the WRAT and CAT, and (b) to examine the relationships which may exist between these academic achievement tests -nd a standard intelligence battery such as the Wechsler Scale. (Author)

  13. Exploring the Role and Influence of Expectations in Achieving VLE Benefit Success

    ERIC Educational Resources Information Center

    Jackson, Stephen; Fearon, Colm

    2014-01-01

    The aim of this paper is to investigate the role and influence of expectations management in realising benefit success when adopting a virtual learning environment (VLE). Based on a discussion of findings from a further and higher education college in the UK, a conceptual expectations management model is developed that explores the factors…

  14. A Cost-Benefit Analysis for Per-Student Expenditures and Academic Achievement

    ERIC Educational Resources Information Center

    Womack, Sid T.; Roberts, Kerry; Bell, C. David; Womack, Karen

    2015-01-01

    Cost-benefit correlations have been subject to "selective sampling" in the media. Usually extremes of data from a very few high-funding and low-funding states are cited in the media to construct the case that there is no relationship between economic inputs and academic outputs. This study, using average per-pupil expenditures and ACT…

  15. Expertise, Ethics Expertise, and Clinical Ethics Consultation: Achieving Terminological Clarity.

    PubMed

    Iltis, Ana S; Sheehan, Mark

    2016-08-01

    The language of ethics expertise has become particularly important in bioethics in light of efforts to establish the value of the clinical ethics consultation (CEC), to specify who is qualified to function as a clinical ethics consultant, and to characterize how one should evaluate whether or not a person is so qualified. Supporters and skeptics about the possibility of ethics expertise use the language of ethics expertise in ways that reflect competing views about what ethics expertise entails. We argue for clarity in understanding the nature of expertise and ethics expertise. To be an ethics expert, we argue, is to be an expert in knowing what ought to be done. Any attempt to articulate expertise with respect to knowing what ought to be done must include an account of ethics that specifies the nature of moral truth and the means by which we access this truth or a theoretical account of ethics such that expertise in another domain is linked to knowing or being better at judging what ought to be done and the standards by which this "knowing" or "being better at judging" is determined. We conclude with a discussion of the implications of our analysis for the literature on ethics expertise in CEC. We do think that there are clear domains in which a clinical ethics consultant might be expert but we are skeptical about the possibility that this includes ethics expertise. Clinical ethics consultants should not be referred to as ethics experts.

  16. Net Clinical Benefit of Oral Anticoagulants: A Multiple Criteria Decision Analysis

    PubMed Central

    Yang, Yea-Huei Kao; Lu, Christine Y.

    2015-01-01

    Background This study quantitatively evaluated the comparative efficacy and safety of new oral anticoagulants (dabigatran, rivaroxaban, and apizaban) and warfarin for treatment of nonvalvular atrial fibrillation. We also compared these agents under different scenarios, including population with high risk of stroke and for primary vs. secondary stroke prevention. Methods We used multiple criteria decision analysis (MCDA) to assess the benefit-risk of these medications. Our MCDA models contained criteria for benefits (prevention of ischemic stroke and systemic embolism) and risks (intracranial and extracranial bleeding). We calculated a performance score for each drug accounting for benefits and risks in comparison to treatment alternatives. Results Overall, new agents had higher performance scores than warfarin; in order of performance scores: dabigatran 150 mg (0.529), rivaroxaban (0.462), apixaban (0.426), and warfarin (0.191). For patients at a higher risk of stroke (CHADS2 score≥3), apixaban had the highest performance score (0.686); performance scores for other drugs were 0.462 for dabigatran 150 mg, 0.392 for dabigatran 110 mg, 0.271 for rivaroxaban, and 0.116 for warfarin. Dabigatran 150 mg had the highest performance score for primary stroke prevention, while dabigatran 110 mg had the highest performance score for secondary prevention. Conclusions Our results suggest that new oral anticoagulants might be preferred over warfarin. Selecting appropriate medicines according to the patient’s condition based on information from an integrated benefit-risk assessment of treatment options is crucial to achieve optimal clinical outcomes. PMID:25897861

  17. Does Homogeneous Ability Grouping for High School Honors English Instruction Benefit the High Achiever?

    ERIC Educational Resources Information Center

    Hostetter, Douglas Paul

    2013-01-01

    Public schools are examining their policies and instructional practices to address the achievement gap exposed by the reporting requirements of NCLB (Wenglinski, 2004). As accountability measures and stakes rise, there is a call for an improved use of scientific evidence to inform educational policymaking (Wiseman, 2010). In terms of the…

  18. Trends in compensation and benefits provided to physical therapy students during clinical education.

    PubMed

    Kondela, P M; Darnell, R E

    1979-10-01

    Many facilities offering physical therapy clinical education for full-time affiliation students also provide some sort of compensation or benefits to students. Fiscal policy trends within health care institutions have influenced the extent to which these benefits are provided. The purpose of this study was to examine trends in providing specific benefits, namely, stipend, housing, meals, and uniform laundry, to students in full-time clinical education at the University of Michigan from 1967 to 1977. Data from annual facility information forms showed that, in general, these benefits have decreased during the years examined. PMID:493344

  19. Feedback and assessment for clinical placements: achieving the right balance

    PubMed Central

    Burgess, Annette; Mellis, Craig

    2015-01-01

    During clinical placements, the provision of feedback forms an integral part of the learning process and enriches students’ learning experiences. The purpose of feedback is to improve the learner’s knowledge, skills, or behavior. Receipt of accurate feedback can help to narrow the gap between actual and desired performance. Effective and regular feedback has the potential to reinforce good practice and motivate the learner toward the desired outcome. Despite the obvious role of feedback in effective teaching and learning, a common complaint from students is that they do not receive adequate feedback. Unfortunately, skills in giving and receiving feedback are rarely taught to students or clinicians. This study aims to provide an understanding of the role of feedback within the learning process, consider consequences of inadequate or poorly given feedback, consider the barriers to the feedback process, provide practical guidelines for providing feedback, and consider the need for student and faculty development in feedback skills. PMID:26056511

  20. Facilitating cells: Translation of hematopoietic chimerism to achieve clinical tolerance.

    PubMed

    Ildstad, Suzanne T; Leventhal, Joseph; Wen, Yujie; Yolcu, Esma

    2015-04-01

    For over 50 y the association between hematopoietic chimerism and tolerance has been recognized. This originated with the brilliant observation by Dr. Ray Owen that freemartin cattle twins that shared a common placental blood supply were red blood cell chimeras, which led to the discovery that hematopoietic chimerism resulted in actively acquired tolerance. This was first confirmed in neonatal mice by Medawar et al. and subsequently in adult rodents. Fifty years later this concept has been successfully translated to solid organ transplant recipients in the clinic. The field is new, but cell-based therapies are being used with increasing frequency to induce tolerance and immunomodulation. The future is bright. This review focuses on chimerism and tolerance: past, present and prospects for the future.

  1. The Benefits of Exercise for the Clinically Depressed

    PubMed Central

    Craft, Lynette L.; Perna, Frank M.

    2004-01-01

    Millions of Americans suffer from clinical depression each year. Most depressed patients first seek treatment from their primary care providers. Generally, depressed patients treated in primary care settings receive pharmacologic therapy alone. There is evidence to suggest that the addition of cognitive-behavioral therapies, specifically exercise, can improve treatment outcomes for many patients. Exercise is a behavioral intervention that has shown great promise in alleviating symptoms of depression. The current review discusses the growing body of research examining the exercise-depression relationship that supports the efficacy of exercise as an adjunct treatment. Databases searched were Medline, PsycLit, PubMed, and SportsDiscus from the years 1996 through 2003. Terms used in the search were clinical depression, depression, exercise, and physical activity. Further, because primary care physicians deliver important mental health services to the majority of depressed patients, several specific recommendations are made regarding counseling these patients on the adoption and maintenance of exercise programs. PMID:15361924

  2. Clinical benefits of diffusion tensor imaging in hydrocephalus.

    PubMed

    Ben-Sira, Liat; Goder, Noam; Bassan, Haim; Lifshits, Shlomi; Assaf, Yaniv; Constantini, Shlomi

    2015-08-01

    OBJECT The object of this study was to use diffusion tensor imaging (DTI) to evaluate and characterize white matter changes in hydrocephalus. METHODS The authors performed a retrospective analysis of DTI in a cohort of patients with hydrocephalus (n = 35), 19 of whom had both pre- and postsurgical imaging studies. These patient's DTI values were compared with values extracted from age-dependent trend lines computed from a healthy subject group (n = 70, age span 14 months-14 years). Several DTI parameters in different regions of interest (ROIs) were evaluated to find the most sensitive parameters for clinical decision making in hydrocephalus. RESULTS Compared with healthy controls, patients with active hydrocephalus had a statistically significant change in all DTI parameters. The most sensitive and specific DTI parameter for predicting hydrocephalus was axial diffusivity (λ1) measured at the level of the corona radiata. Diffusion tensor imaging parameters correlated with several conventional radiological parameters in the assessment of hydrocephalus but were not superior to them. There was no convincing correlation between clinical disease severity and DTI parameters. When examining the pre- and postsurgical effect, it was found that DTI may be a sensitive tool for estimating tissue improvement. CONCLUSIONS This large-cohort study with a multidisciplinary approach combining clinical, neurological, radiological, and multiple DTI parameters revealed the most sensitive DTI parameters for identifying hydrocephalus and suggested that they may serve as an important tool for the disorder's quantitative radiological assessment.

  3. Achieving the Benefits of a High-Potassium, Paleolithic Diet, Without the Toxicity.

    PubMed

    Palmer, Biff F; Clegg, Deborah J

    2016-04-01

    The average US dietary intake of K(+) is well below the current recommended nutritional requirements. This deficiency is even more striking when comparing our current intake with that of our ancestors, who consumed large amounts of dietary K(+). K(+) deficiency has been implicated in many diseases including cardiovascular disease, kidney stones, and osteoporosis. Importantly, dietary supplementation of K(+) has favorable effects on reducing blood pressure, decreasing the risk of stroke, improving bone health, and reducing the risk of nephrolithiasis. For this comprehensive review, we scanned the literature using PubMed and MEDLINE using the following search terms: potassium intake, renal potassium excretion, and prevention of hyperkalemia. Articles were selected for inclusion if they represented primary data or review articles published between 1980 and 2015 in high-impact journals. The normal kidney has the capacity to tightly regulate K(+) homoeostasis. We discuss new findings with respect to sensing mechanisms by which the kidney maintains K(+) homeostasis in the gastrointestinal tract and distal tubule. There are widely prescribed hypertensive medications that cause hyperkalemia and thus require dietary K(+) restriction. We conclude by discussing newly approved drugs capable of binding K(+) in the gastrointestinal tract and speculate that this new pharmacology might allow diet liberalization in patients at risk for hyperkalemia, affording them the numerous benefits of a K(+)-rich diet. PMID:26948054

  4. Achieving the Benefits of a High-Potassium, Paleolithic Diet, Without the Toxicity.

    PubMed

    Palmer, Biff F; Clegg, Deborah J

    2016-04-01

    The average US dietary intake of K(+) is well below the current recommended nutritional requirements. This deficiency is even more striking when comparing our current intake with that of our ancestors, who consumed large amounts of dietary K(+). K(+) deficiency has been implicated in many diseases including cardiovascular disease, kidney stones, and osteoporosis. Importantly, dietary supplementation of K(+) has favorable effects on reducing blood pressure, decreasing the risk of stroke, improving bone health, and reducing the risk of nephrolithiasis. For this comprehensive review, we scanned the literature using PubMed and MEDLINE using the following search terms: potassium intake, renal potassium excretion, and prevention of hyperkalemia. Articles were selected for inclusion if they represented primary data or review articles published between 1980 and 2015 in high-impact journals. The normal kidney has the capacity to tightly regulate K(+) homoeostasis. We discuss new findings with respect to sensing mechanisms by which the kidney maintains K(+) homeostasis in the gastrointestinal tract and distal tubule. There are widely prescribed hypertensive medications that cause hyperkalemia and thus require dietary K(+) restriction. We conclude by discussing newly approved drugs capable of binding K(+) in the gastrointestinal tract and speculate that this new pharmacology might allow diet liberalization in patients at risk for hyperkalemia, affording them the numerous benefits of a K(+)-rich diet.

  5. No clinical benefit of gender-specific total knee arthroplasty

    PubMed Central

    Zhu, Chen; Wang, Jiaxing; Cheng, Mengqi; Peng, Xiaochun; Wang, Qi; Zhang, Xianlong

    2014-01-01

    Background and purpose There is no consensus regarding the clinical relevance of gender-specific prostheses in total knee arthroplasty (TKA). We summarize the current best evidence in a comparison of clinical and radiographic outcomes between gender-specific prostheses and standard unisex prostheses in female patients. Methods We used the PubMed, Embase, Cochrane, Science Citation Index, and Scopus databases. We included randomized controlled trials published up to January 2013 that compared gender-specific prostheses with standard unisex prostheses in female patients who underwent primary TKAs. Results 6 trials involving 423 patients with 846 knee joints met the inclusion criteria. No statistically significant differences were observed between the 2 designs regarding pain, range of motion (ROM), knee scores, satisfaction, preference, complications, and radiographic results. The gender-specific design (Gender Solutions; Zimmer Inc, Warsaw, Indiana) reduced the prevalence of overhang. However, it had less overall coverage of the femoral condyles compared to the unisex group. In fact, the femoral prosthesis in the standard unisex group matched better than that in the gender-specific group. Interpretation Gender-specific prostheses do not appear to confer any benefit in terms of clinician- and patient-reported outcomes for the female knee. PMID:24954488

  6. Policies to reduce heat islands: Magnitudes of benefits and incentives to achieve them

    SciTech Connect

    Rosenfeld, A.H.; Romm, J.J.; Akbari, H.; Pomerantz, M.; Taha, H.G.

    1996-05-01

    A ``Cool Communities`` strategy of lighter-colored reroofs and resurfaced pavements, and shade trees, can directly lower annual air conditioning bills in Los Angeles (LA) by about $100 million (M), cool the air in the LA Basin (thereby saving indirectly $70M more in air conditioning), and reduce smog exceedance by about 10%, worth another $360M, for a total savings of about $0.5 billion per year. Trees are most effective if they shade buildings; but they are still very cost effective if they merely cool the air by evapotranspiration. Avoided peak power for air conditioning can be about 1.5GW (more than 15% of LA air conditioning). Extrapolated to the entire US, the authors estimate 20GW avoided and potential annual electricity savings of about $5--10B in 2015. To achieve these savings, they call for ratings and labels for cool materials, buildings` performance standards, utility incentive programs, and an extension of the existing smog-offset trading market (RECLAIM) to include credit for cool surfaces and trees. EPA can include cool materials and trees in its proposed regional ``open market smog-offset trading credits``.

  7. Clinical benefits of routine varicella vaccination for adults.

    PubMed

    Germinario, Cinzia; Gallone, Maria Serena; Cappelli, Maria Giovanna; Tafuri, Silvio

    2015-01-01

    Varicella is a highly contagious disease caused by varicella zoster virus. In children, it is generally a mild to moderate illness while it is often more severe in adults, with serious complications as dehydration, pneumonia, bleeding problems, infection or inflammation of the brain, secondary bacterial infections, sepsis, toxic shock syndrome, bone infections, joint infections and deaths. Some groups of adults are at major risk of complications, in particular immunocompromised persons as subjects with impaired humoral immunity and who is receiving systemic steroids, persons who live or work in environments in which transmission of varicella is likely, health-care personnel and pregnant women. After the introduction of Universal Mass Vaccination (UMV), the first mathematical models suggested that vaccination will lead to a shift in the average age at infection from children to adults with an increasing numbers of complicated forms, nevertheless new models predicted that, although an upward shift in the age at infection may occur, the overall morbidity due to varicella is likely to decrease. Current literature seems to suggest that for public health authorities the key action to prevent an increase of varicella incidence among adults is to achieve high vaccination coverage among babies and adolescents in countries who adopted UMV.

  8. Decision theory and the evaluation of risks and benefits of clinical trials.

    PubMed

    Bernabe, Rosemarie D C; van Thiel, Ghislaine J M W; Raaijmakers, Jan A M; van Delden, Johannes J M

    2012-12-01

    Research ethics committees (RECs) are tasked to assess the risks and the benefits of a clinical trial. In previous studies, it was shown that RECs find this task difficult, if not impossible, to do. The current approaches to benefit-risk assessment (i.e. Component Analysis and the Net Risk Test) confound the various risk-benefit tasks, and as such, make balancing impossible. In this article, we show that decision theory, specifically through the expected utility theory and multiattribute utility theory, enable for an explicit and ethically weighted risk-benefit evaluation. This makes a balanced ethical justification possible, and thus a more rationally defensible decision making. PMID:22819925

  9. Intelligent use and clinical benefits of electronic health records in rheumatoid arthritis.

    PubMed

    Carroll, Robert J; Eyler, Anne E; Denny, Joshua C

    2015-03-01

    In the past 10 years, electronic health records (EHRs) have had growing impact in clinical care. EHRs efficiently capture and reuse clinical information, which can directly benefit patient care by guiding treatments and providing effective reminders for best practices. The increased adoption has also lead to more complex implementations, including robust, disease-specific tools, such as for rheumatoid arthritis (RA). In addition, the data collected through normal clinical care is also used in secondary research, helping to refine patient treatment for the future. Although few studies have directly demonstrated benefits for direct clinical care of RA, the opposite is true for EHR-based research - RA has been a particularly fertile ground for clinical and genomic research that have leveraged typically advanced informatics methods to accurately define RA populations. We discuss the clinical impact of EHRs in RA treatment and their impact on secondary research, and provide recommendations for improved utility in future EHR installations.

  10. Clinical benefits and impact of early use of long‐acting injectable antipsychotics for schizophrenia

    PubMed Central

    Dawson, Gail; Zummo, Jacqueline

    2015-01-01

    Abstract Aim Results from clinical trials support the use of oral antipsychotics for treatment of early or first‐episode psychosis in patients with schizophrenia. This paper will review literature on the advantages of early initiation of treatment for schizophrenia and the clinical benefits of early use of long‐acting injectable antipsychotics (LAIs). Method A comprehensive literature review was conducted to identify published literature on the use of LAIs early in the treatment of schizophrenia. Results Although there is a higher response rate to initial antipsychotic treatment for a first‐episode of schizophrenia than with subsequent antipsychotic treatment, we have not effectively addressed this issue. Poor adherence to treatment is a primary cause of relapse and rehospitalization in subsequent years and was associated with higher relapse rates resulting in devastating effects and substantial economic burden. The costs of nonadherence were estimated to be $1.48 billion. Thus, a major challenge with the treatment of schizophrenia is changing poor adherence to persistence with antipsychotic therapy. LAIs are known to be at least as effective as oral antipsychotics for treating schizophrenia, and yet are underutilized. Further, LAIs address many of the problems associated with adherence to oral therapy. Recent evidence suggests that LAIs are effective for treating first‐episode psychosis and for early initiation of treatment for schizophrenia. Conclusion Although consistent antipsychotic treatment represents a critical part of treatment, a person‐centred approach to treating schizophrenia is essential for all aspects of care, including establishing and maintaining a therapeutic alliance, strengthening shared decision‐making and adherence, and achieving long‐lasting recovery. PMID:26403538

  11. The intelligent use and clinical benefits of electronic medical records in multiple sclerosis

    PubMed Central

    Davis, Mary F.

    2015-01-01

    Summary Electronic medical records (EMRs) are being quickly adopted in clinics around the world. This advancement can greatly enhance the clinical care of patients with multiple sclerosis (MS) by providing formats that allow easier review of medical documents and more structured avenues to store relevant information. MS clinicians should be involved with implementing and updating EMRs at their institutions to ensure EMR formats that benefit MS clinics. EMRs also provide opportunities for research studies of MS to access detailed, longitudinal data of MS disease course that would otherwise be difficult to collect. PMID:25495075

  12. The intelligent use and clinical benefits of electronic medical records in multiple sclerosis.

    PubMed

    Davis, Mary F; Haines, Jonathan L

    2015-02-01

    Electronic medical records (EMRs) are being quickly adopted in clinics around the world. This advancement can greatly enhance the clinical care of patients with multiple sclerosis (MS) by providing formats that allow easier review of medical documents and more structured avenues to store relevant information. MS clinicians should be involved with implementing and updating EMRs at their institutions to ensure EMR formats that benefit MS clinics. EMRs also provide opportunities for research studies of MS to access detailed, longitudinal data of MS disease course that would otherwise be difficult to collect. PMID:25495075

  13. Teacher Research Programs: An Effective Form of Professional Development to Increase Student Achievement and Benefit the Economy

    NASA Astrophysics Data System (ADS)

    Dubner, J.

    2008-12-01

    development. Columbia University's teacher research program is a very effective form of professional development for pre- college science teachers and has a direct correlation to increased student motivation and achievement in science. The Program is premised on the beliefs that hands-on experience in the practice of science improves the quality and authenticity of science teaching, and that improved science teaching is correlated with increased student interest and achievement in science. The author will present the methodology of the program's evaluation citing statistically significant findings. The author will also show the economic benefits of teacher participation in a well-designed research program.

  14. Harms, benefits, and the nature of interventions in pragmatic clinical trials.

    PubMed

    Ali, Joseph; Andrews, Joseph E; Somkin, Carol P; Rabinovich, C Egla

    2015-10-01

    To produce evidence capable of informing healthcare decision making at all critical levels, pragmatic clinical trials are diverse both in terms of the type of intervention (medical, behavioral, and/or technological) and the target of intervention (patients, clinicians, and/or healthcare system processes). Patients and clinicians may be called on to participate as designers, investigators, intermediaries, or subjects of pragmatic clinical trials. Other members of the healthcare team, as well as the healthcare system itself, also may be affected directly or indirectly before, during, or after study implementation. This diversity in the types and targets of pragmatic clinical trial interventions has brought into focus the need to consider whether existing ethics and regulatory principles, policies, and procedures are appropriate for pragmatic clinical trials. Specifically, further examination is needed to identify how the types and targets of pragmatic clinical trial interventions may influence the assessment of net potential risk, understood as the balance of potential harms and benefits. In this article, we build on scholarship seeking to align ethics and regulatory requirements with potential research risks and propose an approach to the assessment of net risks that is sensitive to the diverse nature of pragmatic clinical trial interventions. We clarify the potential harms, burdens, benefits, and advantages of common types of pragmatic clinical trial interventions and discuss implications for patients, clinicians, and healthcare systems.

  15. Applying the benefits of the AwM study in the clinic.

    PubMed

    Dodick, D W

    2008-09-01

    The Act when Mild (AwM) Study has illustrated the benefits to migraineurs of taking triptan medication when their migraine pain is still mild and within 1 h of the onset of symptoms. Yet many patients wait until the attack has fully developed before taking their medication, with potentially inferior outcomes. In order to reproduce the benefits of early intervention using the AwM paradigm in daily practice, a number of key barriers need to be addressed at both the physician and patient level. Notable physician-related barriers to be overcome, particularly at the primary care level, include accuracy of an early diagnosis of migraine in newly presenting patients, communication skills that generate a therapeutic engagement with migraine patients and enhance patient confidence, the application of knowledge about up-to-date strategies to optimize treatment outcomes, and the setting of achievable goals to avoid unrealistic expectations. Patient-related obstacles that need to be identified and overcome encompass patient attitude, expectations, and behaviour. Migraine patients may be reluctant to consult their physician, and, of those who do, many stop consulting because they perceive that physicians can do little to improve their situation. For this reason, migraine patients need to be counselled about the most appropriate medication for their level of symptoms. Moreover, patients need to be confident before they will adhere routinely to the advice they receive, and high in the priority of advice is the use of medication, particularly triptans, at the first sign of a migraine attack, rather than waiting until their attack has progressed to moderate or severe intensity. Patients who adhere to this advice are likely to experience a notable reduction in the pain, disability and time lost that they would otherwise suffer. The beneficial effects of early triptan intervention illustrated in the AwM Study can therefore be best reproduced in the clinic if the correct advice given

  16. First results from a hybrid prototype CT scanner for exploring benefits of quantum-counting in clinical CT

    NASA Astrophysics Data System (ADS)

    Kappler, S.; Hannemann, T.; Kraft, E.; Kreisler, B.; Niederloehner, D.; Stierstorfer, K.; Flohr, T.

    2012-03-01

    μWe introduce a novel hybrid prototype scanner built to explore benefits of the quantum-counting technique in the context of clinical CT. The scanner is equipped with two measurement systems. One is a CdTe-based counting detector with 22cm field-of-view. Its revised ASIC architecture allows configuration of the counter thresholds of the 225m small sub-pixels in chess patterns, enabling data acquisition in four energy bins or studying high-flux scenarios with pile-up trigger. The other one is a conventional GOS-based energy-integrating detector from a clinical CT scanner. The integration of both detection technologies in one CT scanner provides two major advantages. It allows direct comparison of image quality and contrast reproduction as well as instantaneous quantification of the relative dose usage and material separation performance achievable with counting techniques. In addition, data from the conventional detector can be used as complementary information during reconstruction of the images from the counting device. In this paper we present CT images acquired with the hybrid prototype scanner, illustrate its underlying conceptual methods, and provide first experimental results quantifying clinical benefits of quantum-counting CT.

  17. A new proposal for benefit-less-risk analysis in clinical trials.

    PubMed

    Chuang-Stein, C

    1994-02-01

    In this paper, we propose a method to discount the observed benefit of a treatment by the observed risk in order to facilitate the benefit-less-risk comparison of treatments in a clinical trial. The discounting, applied to each individual in a trial, utilizes a method proposed by Chuang-Stein and co-authors to consolidate the safety data collected in the trial. The collating of the safety information allows one to estimate quantitatively the risk experienced by each individual, and therefore enables the construction of a risk-adjusted benefit measure for the same individual. We discuss the rationale for the adjusting method and examine its impact on the inference. When the discounting process reflects an individual's choice, the results should be interpreted at the individual level. An example is given to illustrate the approach. PMID:7908619

  18. [The contribution of clinical cancer registries to benefit assessments: Requirements and first results].

    PubMed

    Klinkhammer-Schalke, Monika; Hofstädter, Ferdinand; Gerken, Michael; Benz, Stefan

    2016-01-01

    Following the adoption of the Cancer Screening and Registry Act (KFRG) to advance the development of the early detection of cancer and to promote quality assurance through Clinical Cancer Registries according to Sect. 65c SGB V, the question is raised as to what extent population-based clinical cancer registries may contribute not only to direct patient treatment benefits, but also to the requirements of health research and to other issues such as, for example, the evaluation of the benefit of new pharmaceutical products. Efforts to improve a nationwide quality management for oncology have so far not been successful in the development of comprehensive documentation at all levels of care. New organizational structures such as population-based clinical cancer registries were supposed to solve this problem more sufficiently, but they must be accompanied by valid trans-sectorial documentation and evaluation of clinical data. The need for specific real-life outcomes (effectiveness) of specific therapies has led to calls for data from outside randomised clinical trials (efficacy). First results are demonstrated in the present article. PMID:27320026

  19. Cooperative study of clinical benefits from use of the fully portable blood irradiator

    SciTech Connect

    Hungate, F.P.

    1994-10-01

    This report looks at the clinical benefits from use of a fully portable blood irradiator, techniques developed by Pacific Northwest Laboratory. Significant accomplishments included the following: blood irradiators were successfully fabricated by PNL; irradiators were activated at the University of Missouri and quality tested at PNL; A-V shunts for irradiators were successfully fabricated in the PNL plastics shop; all activities necessary for experimental work on animals using the blood irradiators were completed.

  20. High-fidelity simulation: Assessment of student nurses' team achievements of clinical judgment.

    PubMed

    Hallin, Karin; Bäckström, Britt; Häggström, Marie; Kristiansen, Lisbeth

    2016-07-01

    Nursing educators have the challenge of preparing nursing students to handle complex patient care situations in real life, but much remains unknown about the ability to make clinical judgments. In this study, high-fidelity simulation (HFS) was used at a Swedish university to find answers about pre-licensure nursing students' success in clinical judgment in terms of team ability and relationships with theoretical achievements, and personal and scenario circumstances. The matrix Lasater Clinical Judgment Rubric (LCJR) was used to analyze and score the students' ability in teams to notice, interpret and respond to complex care situations. Overall, the results showed the student teams in their first meeting with HFS in a complex care situation achieved low clinical judgment points; most teams were in the stages of Beginning and Developing. For attaining high team achievements the majority of the students in the team should theoretically be "high performance". Being observers and having HFS experience before nursing education was significant too. However, age, health care experience, and assistant nurse degrees were of secondary importance. Further research at universities regionally, nationally, and internationally is needed. PMID:27428686

  1. A standardised, generic, validated approach to stratify the magnitude of clinical benefit that can be anticipated from anti-cancer therapies: the European Society for Medical Oncology Magnitude of Clinical Benefit Scale (ESMO-MCBS).

    PubMed

    Cherny, N I; Sullivan, R; Dafni, U; Kerst, J M; Sobrero, A; Zielinski, C; de Vries, E G E; Piccart, M J

    2015-08-01

    The value of any new therapeutic strategy or treatment is determined by the magnitude of its clinical benefit balanced against its cost. Evidence for clinical benefit from new treatment options is derived from clinical research, in particular phase III randomised trials, which generate unbiased data regarding the efficacy, benefit and safety of new therapeutic approaches. To date, there is no standard tool for grading the magnitude of clinical benefit of cancer therapies, which may range from trivial (median progression-free survival advantage of only a few weeks) to substantial (improved long-term survival). Indeed, in the absence of a standardised approach for grading the magnitude of clinical benefit, conclusions and recommendations derived from studies are often hotly disputed and very modest incremental advances have often been presented, discussed and promoted as major advances or 'breakthroughs'. Recognising the importance of presenting clear and unbiased statements regarding the magnitude of the clinical benefit from new therapeutic approaches derived from high-quality clinical trials, the European Society for Medical Oncology (ESMO) has developed a validated and reproducible tool to assess the magnitude of clinical benefit for cancer medicines, the ESMO Magnitude of Clinical Benefit Scale (ESMO-MCBS). This tool uses a rational, structured and consistent approach to derive a relative ranking of the magnitude of clinically meaningful benefit that can be expected from a new anti-cancer treatment. The ESMO-MCBS is an important first step to the critical public policy issue of value in cancer care, helping to frame the appropriate use of limited public and personal resources to deliver cost-effective and affordable cancer care. The ESMO-MCBS will be a dynamic tool and its criteria will be revised on a regular basis. PMID:26026162

  2. Evidence-Based Approach to Fiber Supplements and Clinically Meaningful Health Benefits, Part 2

    PubMed Central

    McRorie, Johnson W.

    2015-01-01

    Dietary fiber that is intrinsic and intact in fiber-rich foods (eg, fruits, vegetables, legumes, whole grains) is widely recognized to have beneficial effects on health when consumed at recommended levels (25 g/d for adult women, 38 g/d for adult men). Most (90%) of the US population does not consume this level of dietary fiber, averaging only 15 g/d. In an attempt to bridge this “fiber gap,” many consumers are turning to fiber supplements, which are typically isolated from a single source. Fiber supplements cannot be presumed to provide the health benefits that are associated with dietary fiber from whole foods. Of the fiber supplements on the market today, only a minority possess the physical characteristics that underlie the mechanisms driving clinically meaningful health benefits. In this 2-part series, the first part (previous issue) described the 4 main characteristics of fiber supplements that drive clinical efficacy (solubility, degree/rate of fermentation, viscosity, and gel formation), the 4 clinically meaningful designations that identify which health benefits are associated with specific fibers, and the gel-dependent mechanisms in the small bowel that drive specific health benefits (eg, cholesterol lowering, improved glycemic control). The second part (current issue) of this 2-part series will focus on the effects of fiber supplements in the large bowel, including the 2 mechanisms by which fiber prevents/relieves constipation (insoluble mechanical irritant and soluble gel-dependent water-holding capacity), the gel-dependent mechanism for attenuating diarrhea and normalizing stool form in irritable bowel syndrome, and the combined large bowel/small bowel fiber effects for weight loss/maintenance. The second part will also discuss how processing for marketed products can attenuate efficacy, why fiber supplements can cause gastrointestinal symptoms, and how to avoid symptoms for better long-term compliance. PMID:25972619

  3. Evidence-Based Approach to Fiber Supplements and Clinically Meaningful Health Benefits, Part 1

    PubMed Central

    McRorie, Johnson W.

    2015-01-01

    Dietary fiber that is intrinsic and intact in fiber-rich foods (eg, fruits, vegetables, legumes, whole grains) is widely recognized to have beneficial effects on health when consumed at recommended levels (25 g/d for adult women, 38 g/d for adult men). Most (90%) of the US population does not consume this level of dietary fiber, averaging only 15 g/d. In an attempt to bridge this “fiber gap,” many consumers are turning to fiber supplements, which are typically isolated from a single source. Fiber supplements cannot be presumed to provide the health benefits that are associated with dietary fiber from whole foods. Of the fiber supplements on the market today, only a minority possess the physical characteristics that underlie the mechanisms driving clinically meaningful health benefits. The first part (current issue) of this 2-part series will focus on the 4 main characteristics of fiber supplements that drive clinical efficacy (solubility, degree/rate of fermentation, viscosity, and gel formation), the 4 clinically meaningful designations that identify which health benefits are associated with specific fibers, and the gel-dependent mechanisms in the small bowel that drive specific health benefits (eg, cholesterol lowering, improved glycemic control). The second part (next issue) of this 2-part series will focus on the effects of fiber supplements in the large bowel, including the 2 mechanisms by which fiber prevents/relieves constipation (insoluble mechanical irritant and soluble gel-dependent water-holding capacity), the gel-dependent mechanism for attenuating diarrhea and normalizing stool form in irritable bowel syndrome, and the combined large bowel/small bowel fiber effects for weight loss/maintenance. The second part will also discuss how processing for marketed products can attenuate efficacy, why fiber supplements can cause gastrointestinal symptoms, and how to avoid symptoms for better long-term compliance. PMID:25972618

  4. Analyzing the blood-brain barrier: the benefits of medical imaging in research and clinical practice.

    PubMed

    Chassidim, Yoash; Vazana, Udi; Prager, Ofer; Veksler, Ronel; Bar-Klein, Guy; Schoknecht, Karl; Fassler, Michael; Lublinsky, Svetlana; Shelef, Ilan

    2015-02-01

    A dysfunctional BBB is a common feature in a variety of brain disorders, a fact stressing the need for diagnostic tools designed to assess brain vessels' permeability in space and time. Biological research has benefited over the years various means to analyze BBB integrity. The use of biomarkers for improper BBB functionality is abundant. Systemic administration of BBB impermeable tracers can both visualize brain regions characterized by BBB impairment, as well as lead to its quantification. Additionally, locating molecular, physiological content in regions from which it is restricted under normal BBB functionality undoubtedly indicates brain pathology-related BBB disruption. However, in-depth research into the BBB's phenotype demands higher analytical complexity than functional vs. pathological BBB; criteria which biomarker based BBB permeability analyses do not meet. The involvement of accurate and engineering sciences in recent brain research, has led to improvements in the field, in the form of more accurate, sensitive imaging-based methods. Improvements in the spatiotemporal resolution of many imaging modalities and in image processing techniques, make up for the inadequacies of biomarker based analyses. In pre-clinical research, imaging approaches involving invasive procedures, enable microscopic evaluation of BBB integrity, and benefit high levels of sensitivity and accuracy. However, invasive techniques may alter normal physiological function, thus generating a modality-based impact on vessel's permeability, which needs to be corrected for. Non-invasive approaches do not affect proper functionality of the inspected system, but lack in spatiotemporal resolution. Nevertheless, the benefit of medical imaging, even in pre-clinical phases, outweighs its disadvantages. The innovations in pre-clinical imaging and the development of novel processing techniques, have led to their implementation in clinical use as well. Specialized analyses of vessels' permeability

  5. Estimating the clinical benefits of vaccinating boys and girls against HPV-related diseases in Europe

    PubMed Central

    2013-01-01

    Background HPV is related to a number of cancer types, causing a considerable burden in both genders in Europe. Female vaccination programs can substantially reduce the incidence of HPV-related diseases in women and, to some extent, men through herd immunity. The objective was to estimate the incremental benefit of vaccinating boys and girls using the quadrivalent HPV vaccine in Europe versus girls-only vaccination. Incremental benefits in terms of reduction in the incidence of HPV 6, 11, 16 and 18-related diseases (including cervical, vaginal, vulvar, anal, penile, and head and neck carcinomas and genital warts) were assessed. Methods The analysis was performed using a model constructed in Microsoft®Excel, based on a previously-published dynamic transmission model of HPV vaccination and published European epidemiological data on incidence of HPV-related diseases. The incremental benefits of vaccinating 12-year old girls and boys versus girls-only vaccination was assessed (70% vaccine coverage were assumed for both). Sensitivity analyses around vaccine coverage and duration of protection were performed. Results Compared with screening alone, girls-only vaccination led to 84% reduction in HPV 16/18-related carcinomas in females and a 61% reduction in males. Vaccination of girls and boys led to a 90% reduction in HPV 16/18-related carcinomas in females and 86% reduction in males versus screening alone. Relative to a girls-only program, vaccination of girls and boys led to a reduction in female and male HPV-related carcinomas of 40% and 65%, respectively and a reduction in the incidence of HPV 6/11-related genital warts of 58% for females and 71% for males versus girls-only vaccination. Conclusions In Europe, the vaccination of 12-year old boys and girls against HPV 6, 11, 16 and 18 would be associated with substantial additional clinical benefits in terms of reduced incidence of HPV-related genital warts and carcinomas versus girls-only vaccination. The incremental

  6. Expectations of benefit and tolerance to risk of individuals with spinal cord injury regarding potential participation in clinical trials.

    PubMed

    Kwon, Brian K; Ghag, Arvindera; Dvorak, Marcel F; Tetzlaff, Wolfram; Illes, Judy

    2012-12-10

    We conducted a survey of individuals living with spinal cord injury (SCI) to determine their receptivity to participating in clinical trials of drug therapies or stem cell therapies, their anticipation of therapeutic benefits, and their tolerance to risk. A 46-item questionnaire was administered to individuals with cervical or thoracic SCI identified through a provincial database. The average age was 42 years and the individuals were, on average, 5.5 years post-injury. Receptivity to neuroprotective drug trials in the acute setting was very high, but somewhat less so for stem cell trials in the subacute or chronic (current) setting. With respect to expectation of functional benefit, approximately one third of the respondents indicated that they would want a 5-25% chance of achieving some functional recovery if enrolling in a stem cell therapy clinical trial in the current, chronic injury state. Whereas the majority typically would require the risk of spinal cord damage, cancer, infection, and nerve pain from invasive cell transplantation trials to be ≤1%, 15-30% would participate regardless of the risk of these complications. The factors associated with this high risk tolerance were gender (males>females), age (elderly>young), and self-reported knowledge of SCI research (greater knowledge>less knowledge). Injury severity or chronicity did not have a significant correlation with risk tolerance. Whereas previous studies have shown that the understanding of stem cell science is limited among individuals with SCI, here we show that many still have high hopes for the possibility of neurological benefit, are anxious to participate in invasive stem cell trials, and, in many cases, have high tolerance for risk in such trials. Taken together, the data underscore the need for careful communication with individuals with SCI to avoid unrealistic expectations and therapeutic misconception in experimental trials.

  7. Clinical decision support systems for improving diagnostic accuracy and achieving precision medicine.

    PubMed

    Castaneda, Christian; Nalley, Kip; Mannion, Ciaran; Bhattacharyya, Pritish; Blake, Patrick; Pecora, Andrew; Goy, Andre; Suh, K Stephen

    2015-01-01

    As research laboratories and clinics collaborate to achieve precision medicine, both communities are required to understand mandated electronic health/medical record (EHR/EMR) initiatives that will be fully implemented in all clinics in the United States by 2015. Stakeholders will need to evaluate current record keeping practices and optimize and standardize methodologies to capture nearly all information in digital format. Collaborative efforts from academic and industry sectors are crucial to achieving higher efficacy in patient care while minimizing costs. Currently existing digitized data and information are present in multiple formats and are largely unstructured. In the absence of a universally accepted management system, departments and institutions continue to generate silos of information. As a result, invaluable and newly discovered knowledge is difficult to access. To accelerate biomedical research and reduce healthcare costs, clinical and bioinformatics systems must employ common data elements to create structured annotation forms enabling laboratories and clinics to capture sharable data in real time. Conversion of these datasets to knowable information should be a routine institutionalized process. New scientific knowledge and clinical discoveries can be shared via integrated knowledge environments defined by flexible data models and extensive use of standards, ontologies, vocabularies, and thesauri. In the clinical setting, aggregated knowledge must be displayed in user-friendly formats so that physicians, non-technical laboratory personnel, nurses, data/research coordinators, and end-users can enter data, access information, and understand the output. The effort to connect astronomical numbers of data points, including '-omics'-based molecular data, individual genome sequences, experimental data, patient clinical phenotypes, and follow-up data is a monumental task. Roadblocks to this vision of integration and interoperability include ethical, legal

  8. [Radiotherapy for soft tissue sarcomas: Technical evolution and impact on clinical benefit].

    PubMed

    Llacer-Moscardo, C; Bourgier, C; Morel, A; Fenoglietto, P; Carrère, S; Firmin, N; Azria, D

    2016-10-01

    The standard treatment for extremity soft tissue sarcomas is based on the association of surgery and radiotherapy. This strategy allows local control improvement with the risk of increased toxicity. There is therefore a growing interest to identify those patients who will benefit from radiotherapy and those who will have the same local control with surgery alone. Furthermore, the development of toxicity has been correlated with the extension of the irradiated volume and the volume receiving high doses. Technological development as intensity modulated radiotherapy and image-guided radiotherapy allows limited irradiated volume improving the protection of the organs at risk leading to clinical benefit improvement. Moreover, efforts are being done to improve local control for the patients at high risk of local relapse. In this paper, we discuss all these mentioned aspects.

  9. [Radiotherapy for soft tissue sarcomas: Technical evolution and impact on clinical benefit].

    PubMed

    Llacer-Moscardo, C; Bourgier, C; Morel, A; Fenoglietto, P; Carrère, S; Firmin, N; Azria, D

    2016-10-01

    The standard treatment for extremity soft tissue sarcomas is based on the association of surgery and radiotherapy. This strategy allows local control improvement with the risk of increased toxicity. There is therefore a growing interest to identify those patients who will benefit from radiotherapy and those who will have the same local control with surgery alone. Furthermore, the development of toxicity has been correlated with the extension of the irradiated volume and the volume receiving high doses. Technological development as intensity modulated radiotherapy and image-guided radiotherapy allows limited irradiated volume improving the protection of the organs at risk leading to clinical benefit improvement. Moreover, efforts are being done to improve local control for the patients at high risk of local relapse. In this paper, we discuss all these mentioned aspects. PMID:27614501

  10. The Economic Benefits of Closing Educational Achievement Gaps: Promoting Growth and Strengthening the Nation by Improving the Educational Outcomes of Children of Color

    ERIC Educational Resources Information Center

    Lynch, Robert G.; Oakford, Patrick

    2014-01-01

    Our nation is currently experiencing growing levels of income and wealth inequality, which are contributing to longstanding racial and ethnic gaps in education outcomes and other areas. This report quantifies the economic benefits of closing one of the most harmful racial and ethnic gaps: the educational achievement gap that exists between black…

  11. System-Agnostic Clinical Decision Support Services: Benefits and Challenges for Scalable Decision Support

    PubMed Central

    Kawamoto, Kensaku; Del Fiol, Guilherme; Orton, Charles; Lobach, David F

    2010-01-01

    System-agnostic clinical decision support (CDS) services provide patient evaluation capabilities that are independent of specific CDS systems and system implementation contexts. While such system-agnostic CDS services hold great potential for facilitating the widespread implementation of CDS systems, little has been described regarding the benefits and challenges of their use. In this manuscript, the authors address this need by describing potential benefits and challenges of using a system-agnostic CDS service. This analysis is based on the authors’ formal assessments of, and practical experiences with, various approaches to developing, implementing, and maintaining CDS capabilities. In particular, the analysis draws on the authors’ experience developing and leveraging a system-agnostic CDS Web service known as SEBASTIAN. A primary potential benefit of using a system-agnostic CDS service is the relative ease and flexibility with which the service can be leveraged to implement CDS capabilities across applications and care settings. Other important potential benefits include facilitation of centralized knowledge management and knowledge sharing; the potential to support multiple underlying knowledge representations and knowledge resources through a common service interface; improved simplicity and componentization; easier testing and validation; and the enabling of distributed CDS system development. Conversely, important potential challenges include the increased effort required to develop knowledge resources capable of being used in many contexts and the critical need to standardize the service interface. Despite these challenges, our experiences to date indicate that the benefits of using a system-agnostic CDS service generally outweigh the challenges of using this approach to implementing and maintaining CDS systems. PMID:21603281

  12. Using visual and narrative methods to achieve fair process in clinical care.

    PubMed

    Lorenz, Laura S; Chilingerian, Jon A

    2011-02-16

    The Institute of Medicine has targeted patient-centeredness as an important area of quality improvement. A major dimension of patient-centeredness is respect for patient's values, preferences, and expressed needs. Yet specific approaches to gaining this understanding and translating it to quality care in the clinical setting are lacking. From a patient perspective quality is not a simple concept but is best understood in terms of five dimensions: technical outcomes; decision-making efficiency; amenities and convenience; information and emotional support; and overall patient satisfaction. Failure to consider quality from this five-pronged perspective results in a focus on medical outcomes, without considering the processes central to quality from the patient's perspective and vital to achieving good outcomes. In this paper, we argue for applying the concept of fair process in clinical settings. Fair process involves using a collaborative approach to exploring diagnostic issues and treatments with patients, explaining the rationale for decisions, setting expectations about roles and responsibilities, and implementing a core plan and ongoing evaluation. Fair process opens the door to bringing patient expertise into the clinical setting and the work of developing health care goals and strategies. This paper provides a step by step illustration of an innovative visual approach, called photovoice or photo-elicitation, to achieve fair process in clinical work with acquired brain injury survivors and others living with chronic health conditions. Applying this visual tool and methodology in the clinical setting will enhance patient-provider communication; engage patients as partners in identifying challenges, strengths, goals, and strategies; and support evaluation of progress over time. Asking patients to bring visuals of their lives into the clinical interaction can help to illuminate gaps in clinical knowledge, forge better therapeutic relationships with patients living

  13. Using visual and narrative methods to achieve fair process in clinical care.

    PubMed

    Lorenz, Laura S; Chilingerian, Jon A

    2011-01-01

    The Institute of Medicine has targeted patient-centeredness as an important area of quality improvement. A major dimension of patient-centeredness is respect for patient's values, preferences, and expressed needs. Yet specific approaches to gaining this understanding and translating it to quality care in the clinical setting are lacking. From a patient perspective quality is not a simple concept but is best understood in terms of five dimensions: technical outcomes; decision-making efficiency; amenities and convenience; information and emotional support; and overall patient satisfaction. Failure to consider quality from this five-pronged perspective results in a focus on medical outcomes, without considering the processes central to quality from the patient's perspective and vital to achieving good outcomes. In this paper, we argue for applying the concept of fair process in clinical settings. Fair process involves using a collaborative approach to exploring diagnostic issues and treatments with patients, explaining the rationale for decisions, setting expectations about roles and responsibilities, and implementing a core plan and ongoing evaluation. Fair process opens the door to bringing patient expertise into the clinical setting and the work of developing health care goals and strategies. This paper provides a step by step illustration of an innovative visual approach, called photovoice or photo-elicitation, to achieve fair process in clinical work with acquired brain injury survivors and others living with chronic health conditions. Applying this visual tool and methodology in the clinical setting will enhance patient-provider communication; engage patients as partners in identifying challenges, strengths, goals, and strategies; and support evaluation of progress over time. Asking patients to bring visuals of their lives into the clinical interaction can help to illuminate gaps in clinical knowledge, forge better therapeutic relationships with patients living

  14. Diabetic gastrointestinal autonomic neuropathy: current status and new achievements for everyday clinical practice.

    PubMed

    Gatopoulou, A; Papanas, N; Maltezos, E

    2012-09-01

    Gastrointestinal symptoms occur frequently among patients with diabetes mellitus and are associated with considerable morbidity. Diabetic gastrointestinal autonomic neuropathy represents a complex disorder with multifactorial pathogenesis, which is still not well understood. It appears to involve a spectrum of metabolic and cellular changes that affect gastrointestinal motor and sensory control. It may affect any organ in the digestive system. Clinical manifestations are often underestimated, and therefore autonomic neuropathy should be suspected in all diabetic patients with unexplained gastrointestinal symptoms. Advances in technology have now enabled assessment of gastrointestinal motor function. Moreover, novel pharmacological approaches, along with endoscopic and surgical treatment options, contribute to improved outcomes. This review summarises the progress achieved in diabetic gastrointestinal autonomic neuropathy during the last years, focusing on clinical issues of practical importance to the everyday clinician. PMID:22863425

  15. Cost-Benefit Analysis of SCILS for Early Childhood Training in Academic Achievement. Report 1977-78.

    ERIC Educational Resources Information Center

    Steg, D. R.; And Others

    This report documents the long term cost benefits to society of the Self Controlled Interactive Learning Systems (SCILS), a program based on cybernetics and designed to teach early reading skills to children ages 3 to 6. SCILS required children to spend not more than 20 minutes daily using a "talking typewriter," a "talking page," and a "voice…

  16. Engaging diverse social and cultural worlds: perspectives on benefits in international clinical research from South african communities.

    PubMed

    Zvonareva, Olga; Engel, Nora; Ross, Eleanor; Berghmans, Ron; Dhai, Ames; Krumeich, Anja

    2015-04-01

    The issue of benefits in international clinical research is highly controversial. Against the background of wide recognition of the need to share benefits of research, the nature of benefits remains strongly contested. Little is known about the perspectives of research populations on this issue and the extent to which research ethics discourses and guidelines are salient to the expectations and aspirations existing on the ground. This exploratory study contributes to filling this void by examining perspectives of people in low-income South African communities on benefits in international clinical research. Twenty-four individuals with and without experience of being involved in clinical research participated in in-depth interviews. Respondents felt that ancillary care should be provided to clinical research participants, while a clinical study conducted in particular community should bring better health to its members through post-trial benefits. Respondents' perspectives were grounded in the perception that the ultimate goal of international clinical research is to improve local health. We argue that perspectives and understandings of the respondents are shaped by local moral traditions rather than clinical research specificities and require attention as valid moral claims. It is necessary to acknowledge such claims and cultural worlds from which they emerge, thus building the foundation for equal and embracing dialogue to bridge different perspectives and handle contradicting expectations. PMID:23725088

  17. Engaging diverse social and cultural worlds: perspectives on benefits in international clinical research from South african communities.

    PubMed

    Zvonareva, Olga; Engel, Nora; Ross, Eleanor; Berghmans, Ron; Dhai, Ames; Krumeich, Anja

    2015-04-01

    The issue of benefits in international clinical research is highly controversial. Against the background of wide recognition of the need to share benefits of research, the nature of benefits remains strongly contested. Little is known about the perspectives of research populations on this issue and the extent to which research ethics discourses and guidelines are salient to the expectations and aspirations existing on the ground. This exploratory study contributes to filling this void by examining perspectives of people in low-income South African communities on benefits in international clinical research. Twenty-four individuals with and without experience of being involved in clinical research participated in in-depth interviews. Respondents felt that ancillary care should be provided to clinical research participants, while a clinical study conducted in particular community should bring better health to its members through post-trial benefits. Respondents' perspectives were grounded in the perception that the ultimate goal of international clinical research is to improve local health. We argue that perspectives and understandings of the respondents are shaped by local moral traditions rather than clinical research specificities and require attention as valid moral claims. It is necessary to acknowledge such claims and cultural worlds from which they emerge, thus building the foundation for equal and embracing dialogue to bridge different perspectives and handle contradicting expectations.

  18. The relationship between medical students’ epistemological beliefs and achievement on a clinical performance examination

    PubMed Central

    Oh, Sun-A; Chung, Eun-Kyung; Han, Eui-Ryoung; Woo, Young-Jong; Kevin, Deiter

    2016-01-01

    Purpose: This study was to explore the relationship between clinical performance examination (CPX) achievement and epistemological beliefs to investigate the potentials of epistemological beliefs in ill-structured medical problem solving tasks. Methods: We administered the epistemological beliefs questionnaire (EBQ) to fourth-year medical students and correlated the results with their CPX scores. The EBQ comprised 61 items reflecting five belief systems: certainty of knowledge, source of knowledge, rigidity of learning, ability to learn, and speed of knowledge acquisition. The CPX included scores for history taking, physical examination, and patient-physician interaction. Results: The higher epistemological beliefs group obtained significantly higher scores on the CPX with regard to history taking and patient-physician interaction. The epistemological beliefs scores on certainty of knowledge and source of knowledge were significantly positively correlated with patient-physician interaction. The epistemological beliefs scores for ability to learn were significantly positively correlated with those for history taking, physical examination, and patient-physician interaction. Conclusion: Students with more sophisticated and advanced epistemological beliefs stances used more comprehensive and varied approaches in the patient-physician interaction. Therefore, educational efforts that encourage discussions pertaining to epistemological views should be considered to improve clinical reasoning and problem-solving competence in the clinic setting. PMID:26838566

  19. A Pharmacist-Staffed, Virtual Gout Management Clinic for Achieving Target Serum Uric Acid Levels: A Randomized Clinical Trial

    PubMed Central

    Goldfien, Robert; Pressman, Alice; Jacobson, Alice; Ng, Michele; Avins, Andrew

    2016-01-01

    Context: Relatively few patients with gout receive appropriate treatment. Objective: To determine whether a pharmacist-staffed gout management program is more effective than usual care in achieving target serum uric acid (sUA) levels in gout patients. Design: A parallel-group, randomized controlled trial of a pharmacist-staffed, telephone-based program for managing hyperuricemia vs usual care. Trial duration was 26 weeks. Main Outcome Measures: Primary outcome measure was achieving sUA levels at or below 6 mg/dL at the 26-week visit. Secondary outcome was mean change in sUA levels in the control and intervention groups. Participants were adults with recurrent gout and sUA levels above 6.0 mg/dL. Participants were randomly assigned to management by a clinical pharmacist following protocol or to monitoring of sUA levels but management of their gout by their usual treating physician. Results: Of 102 patients who met eligibility criteria, 77 subjects obtained a baseline sUA measurement and were entered into the trial. Among 37 participants in the intervention group, 13 (35%) had sUA levels at or below 6.0 mg/dL at 26 weeks, compared with 5 (13%) of 40 participants in the control group (risk ratio = 2.8, 95% confidence interval [CI] = 1.1 to 7.1, p = 0.03). The mean change in sUA levels among controls was +0.1 mg/dL compared with −1.5 mg/dL in the intervention group (sUA difference = −1.6, 95% CI = −0.9 to −2.4, p < 0.001). Conclusions: A structured pharmacist-staffed program was more effective than usual care for achieving target sUA levels. These results suggest a structured program could greatly improve gout management. PMID:27352414

  20. Public voices in pharmaceutical deliberations: negotiating "clinical benefit" in the FDA's Avastin Hearing.

    PubMed

    Teston, Christa B; Graham, S Scott; Baldwinson, Raquel; Li, Andria; Swift, Jessamyn

    2014-06-01

    This article offers a hybrid rhetorical-qualitative discourse analysis of the FDA's 2011 Avastin Hearing, which considered the revocation of the breast cancer indication for the popular cancer drug Avastin. We explore the multiplicity of stakeholders, the questions that motivated deliberations, and the kinds of evidence presented during the hearing. Pairing our findings with contemporary scholarship in rhetorical stasis theory, Mol's (2002) construct of multiple ontologies, and Callon, Lascoumes, and Barthe's (2011) "hybrid forums," we demonstrate that the FDA's deliberative procedures elides various sources of evidence and the potential multiplicity of definitions for "clinical benefit." Our findings suggest that while the FDA invited multiple stakeholders to offer testimony, there are ways that the FDA might have more meaningfully incorporated public voices in the deliberative process. We conclude with suggestions for how a true hybrid forum might be deployed. PMID:24682644

  1. Statins as anti-cancer therapy; Can we translate preclinical and epidemiologic data into clinical benefit?

    PubMed

    Chae, Young Kwang; Yousaf, Muhammad; Malecek, Mary-Kate; Carneiro, Benedito; Chandra, Sunandana; Kaplan, Jason; Kalyan, Aparna; Sassano, Antonella; Platanias, Leonidas C; Giles, Francis

    2015-12-01

    Statins, the most commonly prescribed class of drug, have demonstrated effects beyond cholesterol reduction including anti-tumor and immunomodulatory properties. Several epidemiological studies have suggested an anti-neoplastic effect of statins evidenced by reductions in cancer incidence and cancer-related mortality. Clinical trials on statins as part of therapy for cancer have generated interest in the oncology community. Statins have been investigated for a variety of cancers, early and late stage, and in combination with chemotherapy and radiation. So far promising results have been reported with statin use in pediatric brainstem tumors, early stage breast cancer, hepatocellular carcinoma (HCC), colorectal cancer (CRC), refractory or relapsed multiple myeloma (MM), and refractory acute myeloid leukemia (AML). There is still much investigation to be completed to determine which subtypes of patients benefit from statin therapy, how statins may potentiate other anticancer approaches, and the appropriate dosing schedule to use.

  2. Public voices in pharmaceutical deliberations: negotiating "clinical benefit" in the FDA's Avastin Hearing.

    PubMed

    Teston, Christa B; Graham, S Scott; Baldwinson, Raquel; Li, Andria; Swift, Jessamyn

    2014-06-01

    This article offers a hybrid rhetorical-qualitative discourse analysis of the FDA's 2011 Avastin Hearing, which considered the revocation of the breast cancer indication for the popular cancer drug Avastin. We explore the multiplicity of stakeholders, the questions that motivated deliberations, and the kinds of evidence presented during the hearing. Pairing our findings with contemporary scholarship in rhetorical stasis theory, Mol's (2002) construct of multiple ontologies, and Callon, Lascoumes, and Barthe's (2011) "hybrid forums," we demonstrate that the FDA's deliberative procedures elides various sources of evidence and the potential multiplicity of definitions for "clinical benefit." Our findings suggest that while the FDA invited multiple stakeholders to offer testimony, there are ways that the FDA might have more meaningfully incorporated public voices in the deliberative process. We conclude with suggestions for how a true hybrid forum might be deployed.

  3. Harms, benefits, and the nature of interventions in pragmatic clinical trials

    PubMed Central

    Ali, Joseph; Andrews, Joseph E; Somkin, Carol P; Rabinovich, C Egla

    2015-01-01

    To produce evidence capable of informing healthcare decision making at all critical levels, pragmatic clinical trials (PCTs) are diverse both in terms of the type of intervention (medical, behavioral, and/or technological) and the target of intervention (patients, clinicians, and/or healthcare system processes). Patients and clinicians may be called on to participate as designers, investigators, intermediaries, or subjects of PCTs. Other members of the healthcare team, as well as the healthcare system itself, also may be affected directly or indirectly before, during, or after study implementation. This diversity in the types and targets of PCT interventions has brought into focus the need to consider whether existing ethics and regulatory principles, policies, and procedures are appropriate for PCTs. Specifically, further examination is needed to identify how the types and targets of PCT interventions may influence the assessment of net potential risk, understood as the balance of potential harms and benefits. In this paper, we build on scholarship seeking to align ethics and regulatory requirements with potential research risks and propose an approach to the assessment of net risks that is sensitive to the diverse nature of PCT interventions. We clarify the potential harms, burdens, benefits, and advantages of common types of PCT interventions and discuss implications for patients, clinicians, and healthcare systems. PMID:26374680

  4. Pre-operative Thresholds for Achieving Meaningful Clinical Improvement after Arthroscopic Treatment of Femoroacetabular Impingement

    PubMed Central

    Nwachukwu, Benedict U.; Fields, Kara G.; Nawabi, Danyal H.; Kelly, Bryan T.; Ranawat, Anil S.

    2016-01-01

    Objectives: Knowledge of the thresholds and determinants for successful femoroacetabular impingement (FAI) treatment is evolving. The primary purpose of this study was to define pre-operative outcome score thresholds that can be used to predict patients most likely to achieve meaningful clinically important difference (MCID) after arthroscopic FAI treatment. Secondarily determinants of achieving MCID were evaluated. Methods: A prospective institutional hip arthroscopy registry was reviewed to identify patients with FAI treated with arthroscopic labral surgery, acetabular rim trimming, and femoral osteochondroplasty. The modified Harris Hip Score (mHHS), the Hip Outcome Score (HOS) and the international Hip Outcome Tool (iHOT-33) tools were administered at baseline and at one year post-operatively. MCID was calculated using a distribution-based method. A receiver operating characteristic (ROC) analysis was used to calculate cohort-based threshold values predictive of achieving MCID. Area under the curve (AUC) was used to define predictive ability (strength of association) with AUC >0.7 considered acceptably predictive. Univariate and multivariable analyses were used to analyze demographic, radiographic and intra-operative factors associated with achieving MCID. Results: There were 374 patients (mean + SD age, 32.9 + 10.5) and 56.4% were female. The MCID for mHHS, HOS activities of daily living (HOS-ADL), HOS Sports, and iHOT-33 was 8.2, 8.4,14.5, and 12.0 respectively. ROC analysis (threshold, % achieving MCID, strength of association) for these tools in our population was: mHHS (61.6, 78%, 0.68), HOS-ADL (83.8, 68%, 0.84), HOS-Sports (63.9, 64%, 0.74), and iHOT-33 (54.3, 82%, 0.65). Likelihood for achieving MCID declined above and increased below these thresholds. In univariate analysis female sex, femoral version, lower acetabular outerbridge score and increasing CT sagittal center edge angle (CEA) were predictive of achieving MCID. In multivariable analysis

  5. Benefits of Hybrid-Electric Propulsion to Achieve 4x Increase in Cruise Efficiency for a VTOL Aircraft

    NASA Technical Reports Server (NTRS)

    Fredericks, William J.; Moore, Mark D.; Busan, Ronald C.

    2013-01-01

    Electric propulsion enables radical new vehicle concepts, particularly for Vertical Takeoff and Landing (VTOL) aircraft because of their significant mismatch between takeoff and cruise power conditions. However, electric propulsion does not merely provide the ability to normalize the power required across the phases of flight, in the way that automobiles also use hybrid electric technologies. The ability to distribute the thrust across the airframe, without mechanical complexity and with a scale-free propulsion system, is a new degree of freedom for aircraft designers. Electric propulsion is scale-free in terms of being able to achieve highly similar levels of motor power to weight and efficiency across a dramatic scaling range. Applying these combined principles of electric propulsion across a VTOL aircraft permits an improvement in aerodynamic efficiency that is approximately four times the state of the art of conventional helicopter configurations. Helicopters typically achieve a lift to drag ratio (L/D) of between 4 and 5, while the VTOL aircraft designed and developed in this research were designed to achieve an L/D of approximately 20. Fundamentally, the ability to eliminate the problem of advancing and retreating rotor blades is shown, without resorting to unacceptable prior solutions such as tail-sitters. This combination of concept and technology also enables a four times increase in range and endurance while maintaining the full VTOL and hover capability provided by a helicopter. Also important is the ability to achieve low disc-loading for low ground impingement velocities, low noise and hover power minimization (thus reducing energy consumption in VTOL phases). This combination of low noise and electric propulsion (i.e. zero emissions) will produce a much more community-friendly class of vehicles. This research provides a review of the concept brainstorming, configuration aerodynamic and mission analysis, as well as subscale prototype construction and

  6. Pellagra-like condition is xeroderma pigmentosum/Cockayne syndrome complex and niacin confers clinical benefit.

    PubMed

    Hijazi, H; Salih, M A; Hamad, M H A; Hassan, H H; Salih, S B M; Mohamed, K A; Mukhtar, M M; Karrar, Z A; Ansari, S; Ibrahim, N; Alkuraya, F S

    2015-01-01

    An extremely rare pellagra-like condition has been described, which was partially responsive to niacin and associated with a multisystem involvement. The condition was proposed to represent a novel autosomal recessive entity but the underlying mutation remained unknown for almost three decades. The objective of this study was to identify the causal mutation in the pellagra-like condition and investigate the mechanism by which niacin confers clinical benefit. Autozygosity mapping and exome sequencing were used to identify the causal mutation, and comet assay on patient fibroblasts before and after niacin treatment to assess its effect on DNA damage. We identified a single disease locus that harbors a novel mutation in ERCC5, thus confirming that the condition is in fact xeroderma pigmentosum/Cockayne syndrome (XP/CS) complex. Importantly, we also show that the previously described dermatological response to niacin is consistent with a dramatic protective effect against ultraviolet-induced DNA damage in patient fibroblasts conferred by niacin treatment. Our findings show the power of exome sequencing in reassigning previously described novel clinical entities, and suggest a mechanism for the dermatological response to niacin in patients with XP/CS complex. This raises interesting possibilities about the potential therapeutic use of niacin in XP.

  7. Lipid target achievement among patients with very high and high cardiovascular risk in a lipid clinic.

    PubMed

    Barkas, Fotios; Liberopoulos, Evangelos N; Kostapanos, Michael S; Liamis, George; Tziallas, Dimitrios; Elisaf, Moses

    2015-04-01

    This was a retrospective study that assessed achievement of lipid-lowering treatment targets in the setting of a University Hospital Lipid Clinic. Low-density lipoprotein cholesterol (LDL-C) goal attainment according to National Cholesterol Education Program-Adult Treatment Panel III (NCEP ATP III) and European Society of Cardiology/European Atherosclerosis Society (ESC/EAS) guidelines was recorded in 1000 consecutive adult patients followed for ≥3 years (mean 8 years). The LDL-C targets according to the NCEP ATP III were attained by 66% and 86% of patients with "very high" (n = 477) and "high" (n = 408) cardiovascular risk, respectively. Fewer patients were within LDL-C goals according to the ESC/EAS guidelines: 25% and 42%. Overall, 92% of the patients were on statins: 67% were on statin monotherapy, while 33% were on combinations with ezetimibe (25%), ω-3 fatty acids (5%), fibrates (4%), or colesevelam (2%). Even in a specialist lipid clinic, a large proportion of patients are not at goal according to the recent ESC/EAS guidelines. PMID:24830420

  8. Prolonged clinical benefit of everolimus therapy in the management of high-grade pancreatic neuroendocrine carcinoma.

    PubMed

    Fonseca, Paula J; Uriol, Esther; Galván, José A; Alvarez, Carlos; Pérez, Quionia; Villanueva, Noemi; Berros, José P; Izquierdo, Marta; Viéitez, José M

    2013-01-01

    Treatment options for patients with high-grade pancreatic neuroendocrine tumors (pNET) are limited, especially for those with progressive disease and for those who experience treatment failure. Everolimus, an oral inhibitor of mammalian target of rapamycin (mTOR), has been approved for the treatment of patients with low- or intermediate-grade advanced pNET. In the randomized phase III RADIANT-3 study in patients with low- or intermediate-grade advanced pNET, everolimus significantly increased progression-free survival (PFS) and decreased the relative risk for disease progression by 65% over placebo. This case report describes a heavily pretreated patient with high-grade pNET and liver and peritoneal metastases who achieved prolonged PFS, clinically relevant partial radiologic tumor response, and resolution of constitutional symptoms with improvement in Karnofsky performance status while receiving a combination of everolimus and octreotide long-acting repeatable (LAR). Radiologic and clinical responses were maintained for 19 months, with minimal toxicity over the course of treatment. This case supports the findings that the combination of everolimus plus octreotide LAR may be considered for use in patients with high-grade pNET and progressive disease. Although behavior and aggressiveness are different between low- or intermediate-grade and high-grade pNET, some high-grade pNET may express mTOR; hence, everolimus should be considered in a clinical trial.

  9. Prolonged Clinical Benefit of Everolimus Therapy in the Management of High-Grade Pancreatic Neuroendocrine Carcinoma

    PubMed Central

    Fonseca, Paula J.; Uriol, Esther; Galván, José A.; Álvarez, Carlos; Pérez, Quionia; Villanueva, Noemi; Berros, José P.; Izquierdo, Marta; Viéitez, José M.

    2013-01-01

    Treatment options for patients with high-grade pancreatic neuroendocrine tumors (pNET) are limited, especially for those with progressive disease and for those who experience treatment failure. Everolimus, an oral inhibitor of mammalian target of rapamycin (mTOR), has been approved for the treatment of patients with low- or intermediate-grade advanced pNET. In the randomized phase III RADIANT-3 study in patients with low- or intermediate-grade advanced pNET, everolimus significantly increased progression-free survival (PFS) and decreased the relative risk for disease progression by 65% over placebo. This case report describes a heavily pretreated patient with high-grade pNET and liver and peritoneal metastases who achieved prolonged PFS, clinically relevant partial radiologic tumor response, and resolution of constitutional symptoms with improvement in Karnofsky performance status while receiving a combination of everolimus and octreotide long-acting repeatable (LAR). Radiologic and clinical responses were maintained for 19 months, with minimal toxicity over the course of treatment. This case supports the findings that the combination of everolimus plus octreotide LAR may be considered for use in patients with high-grade pNET and progressive disease. Although behavior and aggressiveness are different between low- or intermediate-grade and high-grade pNET, some high-grade pNET may express mTOR; hence, everolimus should be considered in a clinical trial. PMID:24019785

  10. Clinical Benefits of Memantine Treatment for Alzheimer's Disease in the Okayama Memantine Study II (OMS II).

    PubMed

    Matsuzono, Kosuke; Yamashita, Toru; Ohta, Yasuyuki; Hishikawa, Nozomi; Koike, Makoto; Sato, Kota; Kono, Syoichiro; Deguchi, Kentaro; Nakano, Yumiko; Abe, Koji

    2015-01-01

    The clinical benefits of memantine, depending on the baseline cognitive and affective conditions in real world dementia clinics, have not been completely examined. We performed the "Okayama Memantine Study II (OMS II)" to retrospectively evaluate the clinical effects of memantine monotherapy (n = 38) in Alzheimer's disease (AD) patients using seven batteries to assess dementia at the baseline, at 3, 6, and 12 months. Additionally, we divided 163 AD patients treated with memantine into two subgroups depending on the baseline cognitive score of the Mini-Mental State Examination (MMSE): the MMSE <15 group (n = 36) and the baseline MMSE ≥15 group (n = 127). We also analyzed 71 AD patients based on the baseline behavioral and psychological symptoms of dementia (BPSD) severity using Abe's BPSD score (ABS). Memantine monotherapy maintained cognitive functions until 6 months of treatment, but showed a decrease at 12 months ( *p <  0.05 versus baseline). However, memantine monotherapy greatly improved BPSD symptoms until 12 months ( *p <  0.05,  **p <  0.01) and maintained other affective functions as well as the activity of daily living. Memantine treatment showed similar effects, regardless of the baseline cognitive functions, but showed better effects on ABS for higher baseline cognitive functions. Memantine treatment greatly improved ABS depending on baseline BPSD severity. Our present OMS II showed that memantine monotherapy improved BPSD until 12 months. The higher baseline cognitive subgroup (MMSE ≥15) and the worse baseline BPSD subgroup were expected to show better effects with memantine.

  11. Blood culture series benefit may be limited to selected clinical conditions: time to reassess.

    PubMed

    Khatib, R; Simeunovic, G; Sharma, M; Fakih, M G; Johnson, L B; Briski, L; Lebar, W

    2015-04-01

    Blood cultures are often submitted as series (two to three sets per 24 hours) to maximize sample recovery. We assessed the actual benefit of additional sets. Blood cultures submitted from adults (≥ 18 years old) over 1 year (1 February 2012 to 31 January 2013) were examined. The medical records of patients with positive cultures were reviewed. Cultures with commensal organisms were considered contamination in the absence of a source and clinical findings. The impact of additional sets on antibiotic therapy was estimated. We evaluated 15,394 blood cultures. They were submitted as two to five sets per 24 hours in 12,236 (79.5%) instances. Pathogens were detected in 1227 sets, representing 741 bacteremias, of which 618 (83.4%) were detected in the first set and 123 (16.6%) in the additional sets. Pathogens missed in the first set were recovered from patients receiving antibiotics (n = 72; 58.5%) and after undergoing a procedure (n = 54; 43.9%). The additional sets' results could have influenced antibiotic therapy in 76/6235 (1.2%) instances, including 40 (0.6%) antibiotic switches and 36 (0.6%) possible extensions of therapy. The potential impact of the detection of missed pathogens on antibiotic therapy was not apparent in patients who had an endovascular infection (26/27, 96.3%) and those who lacked an obvious source of pathogens (10/10, 100%). These findings suggest that one blood culture is probably adequate in patients with an obvious source of pathogens. Blood culture series are beneficial in patients without an obvious source of pathogens and in those with endovascular infections. It is time to reassess the benefit of blood culture series, perhaps limiting them to selected conditions.

  12. What level of accuracy is achievable for preclinical dose painting studies on a clinical irradiation platform?

    PubMed

    Trani, Daniela; Reniers, Brigitte; Persoon, Lucas; Podesta, Mark; Nalbantov, Georgi; Leijenaar, Ralph T H; Granzier, Marlies; Yaromina, Ala; Dubois, Ludwig; Verhaegen, Frank; Lambin, Philippe

    2015-05-01

    in a rat tumor model on a clinical platform, with a high accuracy achieved in the delivery of complex dose distributions. Our work demonstrates the technical feasibility of this approach and enables future investigations on the therapeutic effect of preclinical dose painting strategies using a state-of-the-art clinical platform.

  13. High-Flow Nasal Cannula Oxygen Therapy in Adults: Physiological Benefits, Indication, Clinical Benefits, and Adverse Effects.

    PubMed

    Nishimura, Masaji

    2016-04-01

    High-flow nasal cannula (HFNC) oxygen therapy is carried out using an air/oxygen blender, active humidifier, single heated tube, and nasal cannula. Able to deliver adequately heated and humidified medical gas at flows up to 60 L/min, it is considered to have a number of physiological advantages compared with other standard oxygen therapies, including reduced anatomical dead space, PEEP, constant F(IO2), and good humidification. Although few large randomized clinical trials have been performed, HFNC has been gaining attention as an alternative respiratory support for critically ill patients. Published data are mostly available for neonates. For critically ill adults, however, evidence is uneven because the reports cover various subjects with diverse underlying conditions, such as hypoxemic respiratory failure, exacerbation of COPD, postextubation, preintubation oxygenation, sleep apnea, acute heart failure, and conditions entailing do-not-intubate orders. Even so, across the diversity, many published reports suggest that HFNC decreases breathing frequency and work of breathing and reduces the need for respiratory support escalation. Some important issues remain to be resolved, such as definitive indications for HFNC and criteria for timing the starting and stopping of HFNC and for escalating treatment. Despite these issues, HFNC has emerged as an innovative and effective modality for early treatment of adults with respiratory failure with diverse underlying diseases. PMID:27016353

  14. Investigation of benefits and costs of an ophthalmic outreach clinic in general practice.

    PubMed Central

    Gillam, S J; Ball, M; Prasad, M; Dunne, H; Cohen, S; Vafidis, G

    1995-01-01

    BACKGROUND: With the advent of general practitioner fundholding, there has been growth in outreach clinics covering many specialties. The benefits and costs of this model of service provision are unclear. AIM: A pilot study aimed to evaluate an outreach model of ophthalmic care in terms of its impact on general practitioners, their use of secondary ophthalmology services, patients' views, and costs. METHOD: A prospective study, from April 1992 to March 1993, of the introduction of an ophthalmic outreach service in 17 general practices in London was undertaken. An ophthalmic outreach team, comprising an ophthalmic medical practitioner and an ophthalmic nurse, held clinics in the practices once a month. Referral rates to Edgware General Hospital ophthalmology outpatient department over one year from the study practices were compared with those from 17 control practices. General practitioners' assessments of the scheme and its impact on their knowledge and practice of ophthalmology were sought through a postal survey of all partners and interviews with one partner in each practice. Patient surveys were conducted using self-administered structured questionnaires. A costings exercise compared the outreach model with the conventional hospital ophthalmology outpatient clinic. RESULTS: Of 1309 patients seen by the outreach team in the study practices, 480 (37%) were referred to the ophthalmology outpatient department. The annual referral rate to this department from control practices was 9.5 per 10,000 registered patients compared with 3.8 per 10,000 registered patients from study practices. A total of 1187 patients were referred to the outpatient department from control practices. An increase in knowledge of ophthalmology was reported by 18 of 47 general practitioners (38%). Nineteen (40%) of 47 general practitioners took advantage of the opportunity for inservice training with the outreach team; they were more likely to change their routine practice for ophthalmic care

  15. Benefits, risks and ethical considerations in translation of stem cell research to clinical applications in Parkinson's disease.

    PubMed

    Master, Zubin; McLeod, Marcus; Mendez, Ivar

    2007-03-01

    Stem cells are likely to be used as an alternate source of biological material for neural transplantation to treat Parkinson's disease in the not too distant future. Among the several ethical criteria that must be fulfilled before proceeding with clinical research, a favourable benefit to risk ratio must be obtained. The potential benefits to the participant and to society are evaluated relative to the risks in an attempt to offer the participants a reasonable choice. Through examination of preclinical studies transplanting stem cells in animals and the transplantation of fetal tissue in patients with Parkinson's disease, a current set of potential benefits and risks for neural transplantation of stem cells in clinical research of Parkinson's disease are derived. The potential benefits to research participants undergoing stem cell transplantation are relief of parkinsonian symptoms and decreasing doses of parkinsonian drugs. Transplantation of stem cells as a treatment for Parkinson's disease may benefit society by providing knowledge that can be used to help determine better treatments in the future. The risks to research participants undergoing stem cell transplantation include tumour formation, inappropriate stem cell migration, immune rejection of transplanted stem cells, haemorrhage during neurosurgery and postoperative infection. Although some of these risks are general to neurosurgical transplantation and may not be reduced for participants, the potential risk of tumour formation and inappropriate stem cell migration must be minimised before obtaining a favourable potential benefit to risk calculus and to provide participants with a reasonable choice before they enroll in clinical studies.

  16. Clinical benefits of combined chemotherapy with S-1, oxaliplatin, and docetaxel in advanced gastric cancer patients with palliative surgery

    PubMed Central

    Liu, Yan; Feng, Ye; Gao, Yongjian; Hou, Ruizhi

    2016-01-01

    Background and aim Advanced gastric cancer accounts for a substantial portion of cancer-related mortality worldwide. Surgical intervention is the curative therapeutic approach, but patients with advanced gastric cancer are not eligible for the radical resection. The present work aimed to investigate the efficacy and safety of palliative surgery combined with S-1, oxaliplatin, and docetaxel chemotherapy in the treatment of patients with advanced gastric cancer. Method A total of 20 patients who underwent palliative resection of gastric cancer in China–Japan Union Hospital of Jilin University from 2010 to 2011 were evaluated. Days 20–30 postoperative, these patients started to receive chemotherapy of S-1 (40 mg/m2, oral intake twice a day) and intravenous infusion of oxaliplatin (135 mg/m2) and docetaxel (75 mg/m2). After three cycles of chemotherapy (21 days/cycle), patients were evaluated, and only those who responded toward the treatment continued to receive six to eight cycles of the treatment and were included in end point evaluation. Patients’ survival time and adverse reactions observed along the treatment were compared with those treated with FOLFOX. Results Out of 20 patients evaluated, there was one case of complete response, nine cases of partial response, six cases of stable disease, and four cases of progressive disease. The total efficacy (complete response + partial response) and clinical benefit rates were 50% and 80%, respectively. Of importance, the treatment achieved a significantly longer survival time compared to FOLFOX, despite the fact that both regimens shared common adverse reactions. The adverse reactions were gastrointestinal reaction, reduction in white blood cells, and peripheral neurotoxicity. All of them were mild, having no impact on the treatment. Conclusion Combination therapy of S-1, oxaliplatin, and docetaxel improves the survival of gastric cancer patients treated with palliative resection, with adverse reactions being

  17. Experience of an incontinence clinic for older women: no apparent age limit for potential physical and psychological benefits.

    PubMed

    Tannenbaum, C; Bachand, G; Dubeau, C E; Kuchel, G A

    2001-10-01

    Urinary incontinence (UI) is a common but undertreated condition in older women. Although a variety of noninvasive interventions is available, older women may be hesitant to seek care for UI because of misconceptions about normal aging and treatment futility. We sought to evaluate the effectiveness of a UI clinic specifically tailored to the needs of older women to promote a sense of empowerment and to enhance satisfaction with treatment and outcome. We describe a case series of 52 women between the ages of 65 and 98 who were evaluated at the Geriatric Incontinence Clinic at the McGill University Health Centre over a 1-year period. A standardized telephone questionnaire was administered by a nurse consultant 6 months after each subject's final visit to assess patient satisfaction and current incontinence status. Forty-five women (86%) were available for telephone follow-up and completed the questionnaire. Mean age was 80 years, with urge incontinence in 45%, mixed incontinence (stress and urge) in 33%, impaired bladder emptying with urge symptoms in 10%, and other diagnoses in 12%. Overall, a mean reduction of 1.4 incontinent episodes per day was reported. At follow-up, 30% of the subjects reported being cured of their incontinence, 30% had improved, 20% were the same, and 20% were worse. Over 85% of all women reported satisfaction with their new incontinence status. Women of all ages, independent of the type of UI, type of treatment, and cognitive status, were able to achieve reductions in incontinence symptoms. All patients who had worsened were noncompliant with treatment recommendations at follow-up. Older women can derive significant benefit from a UI assessment. Neither advanced age nor category of incontinence precludes improvements or enhanced satisfaction with treatment. Efforts to improve targeting and compliance may improve outcomes. PMID:11703887

  18. Grouped to Achieve: Are There Benefits to Assigning Students to Heterogeneous Cooperative Learning Groups Based on Pre-Test Scores?

    NASA Astrophysics Data System (ADS)

    Werth, Arman Karl

    Cooperative learning has been one of the most widely used instructional practices around the world since the early 1980's. Small learning groups have been in existence since the beginning of the human race. These groups have grown in their variance and complexity overtime. Classrooms are getting more diverse every year and instructors need a way to take advantage of this diversity to improve learning. The purpose of this study was to see if heterogeneous cooperative learning groups based on student achievement can be used as a differentiated instructional strategy to increase students' ability to demonstrate knowledge of science concepts and ability to do engineering design. This study includes two different groups made up of two different middle school science classrooms of 25-30 students. These students were given an engineering design problem to solve within cooperative learning groups. One class was put into heterogeneous cooperative learning groups based on student's pre-test scores. The other class was grouped based on random assignment. The study measured the difference between each class's pre-post gains, student's responses to a group interaction form and interview questions addressing their perceptions of the makeup of their groups. The findings of the study were that there was no significant difference between learning gains for the treatment and comparison groups. There was a significant difference between the treatment and comparison groups in student perceptions of their group's ability to stay on task and manage their time efficiently. Both the comparison and treatment groups had a positive perception of the composition of their cooperative learning groups.

  19. NOTE: On the clinical spatial resolution achievable with protons and heavier charged particle radiotherapy beams

    NASA Astrophysics Data System (ADS)

    Andreo, Pedro

    2009-06-01

    The 'sub-millimetre precision' often claimed to be achievable in protons and light ion beam therapy is analysed using the Monte Carlo code SHIELD-HIT for a broad range of energies. Based on the range of possible values and uncertainties of the mean excitation energy of water and human tissues, as well as of the composition of organs and tissues, it is concluded that precision statements deserve careful reconsideration for treatment planning purposes. It is found that the range of I-values of water stated in ICRU reports 37, 49 and 73 (1984, 1993 and 2005) for the collision stopping power formulae, namely 67 eV, 75 eV and 80 eV, yields a spread of the depth of the Bragg peak of protons and heavier charged particles (carbon ions) of up to 5 or 6 mm, which is also found to be energy dependent due to other energy loss competing interaction mechanisms. The spread is similar in protons and in carbon ions having analogous practical range. Although accurate depth-dose distribution measurements in water can be used at the time of developing empirical dose calculation models, the energy dependence of the spread causes a substantial constraint. In the case of in vivo human tissues, where distribution measurements are not feasible, the problem poses a major limitation. In addition to the spread due to the currently accepted uncertainties of their I-values, a spread of the depth of the Bragg peak due to the varying compositions of soft tissues is also demonstrated, even for cases which could be considered practically identical in clinical practice. For these, the spreads found were similar to those of water or even larger, providing support to international recommendations advising that body-tissue compositions should not be given the standing of physical constants. The results show that it would be necessary to increase the margins of a clinical target volume, even in the case of a water phantom, due to an 'intrinsic basic physics uncertainty', adding to those margins usually

  20. [Clinical efficacy and achievement of a complete remission in depression: increasing interest in treatment with escitalopram].

    PubMed

    Favré, P

    2012-02-01

    Such a prevalent disease as Major Depressive Disorder (MDD), associated with prominent impairment in physical and social functioning, implies as well an increased morbidity and mortality. Long-term treatments are required due to the frequent occurrence of relapses. Patient compliance is a core factor in both acute and continuation treatment, closely related to tolerability issues. We have partially reviewed the literature published on PubMed since 2004 which assess the relative antidepressant efficacy of escitalopram and comparator antidepressants in adult patients who met DSM-IV criteria for major depressive disorder (MDD). Clinically important differences exist between commonly prescribed antidepressants. These analyses are in favor of a superior efficacy and tolerability of long-term escitalopram treatment (10 to 20mg/day) compared with active controls, including selective serotonin re-uptake inhibitors (SSRIs) (paroxetine, citalopram, bupropion, fluoxetine, fluvoxamine, sertraline), serotonin/noradrenaline reuptake inhibitors (SNRIs) (venlafaxine, milnacipran and duloxetine) and noradrenergic and specific serotonergic antidepressants (NaSSAs) (mirtazapine). Cipriani et al. (2009) have performed a network meta-analysis of 12 new generation antidepressants. They have shown that clinically important differences exist between commonly prescribed antidepressants for both efficacy and acceptability in favor of escitalopram and sertraline in acute treatment, defined as 8-week treatment. Kasper et al. (2009) conducted a post-hoc pooled analysis of data from two 6-month randomized controlled trials that revealed superior efficacy and tolerability of escitalopram when compared with paroxetine. The pooled analysis of four randomized, double-blind, active comparator, 6-month trials in MDD, by Wade et al. (2009), showed that short-term outcomes may predict long-term treatment compliance and outcomes. A higher probability of achieving remission was associated with responding

  1. Achievable Convergence Angle and the Effect of Preparation Design on the Clinical Outcome of Full Veneer Crowns in Dogs

    PubMed Central

    Soukup, Jason W.; Snyder, Christopher J.; Karls, Tina L.; Riehl, Jessica

    2012-01-01

    Summary It is widely accepted that the convergence angle of a full veneer crown preparation should be as close to parallel as possible to attain adequate retention/resistance. The shape of the dog’s canine tooth limits the veterinary dentists’ ability to achieve the recommended convergence angle. However, the clinically achievable convergence angle of the canine tooth in dogs has not been evaluated. In addition, the convergence angle and other physical properties of a preparation, such as height and base diameter, have been shown to affect the retention/resistance of full veneer crowns, in vitro. This effect has not been evaluated clinically in the dog. Physical properties of 32 stone dies from full veneer crowns of canine teeth were studied to evaluate the clinically achievable convergence angle and the potential effect physical properties of the preparation had on the clinical outcome of the restoration. The clinically achievable convergence angle was much higher than the current recommendation. There was an association, albeit not statistically significant, between physical properties of a preparation (convergence angle, height, base diameter) and the clinical outcome of the restoration. PMID:21916370

  2. Clinical image benefits after model-based reconstruction for low dose dedicated breast tomosynthesis

    NASA Astrophysics Data System (ADS)

    Haneda, Eri; Tkaczyk, J. Eric; Palma, Giovanni; Iordache, Rǎzvan; Muller, Serge; De Man, Bruno

    2015-03-01

    Model-based iterative reconstruction (MBIR) is implemented to process full clinical data sets of dedicated breast tomosynthesis (DBT) in a low dose condition and achieves less spreading of anatomical structure between slices. MBIR is a statistical based reconstruction which can control the trade-off between data fitting and image regularization. In this study, regularization is formulated with anisotropic prior weighting that independently controls the image regularization between in-plane and out-of-plane voxel neighbors. Studies at complete and partial convergence show that the appropriate formulation of data-fit and regularization terms along with anisotropic prior weighting leads to a solution with improved localization of objects within a more narrow range of slices. This result is compared with the solutions using simultaneous iterative reconstruction technique (SIRT), which is one of the state of art reconstruction in DBT. MBIR yields higher contrast-to-noise for medium and large size microcalcifications and diagnostic structures in volumetric breast images and supports opportunity for dose reduction for 3D breast imaging.

  3. Is there a clinical benefit with a smooth compensator design compared with a plunged compensator design for passive scattered protons?

    PubMed

    Tabibian, Art A; Powers, Adam; Dolormente, Keith; Oommen, Sneha; Tiwari, Akhil; Palmer, Matt; Zhu, Xiaorong R; Li, Heng; Sahoo, Narayan; Wisdom, Paul; Velasco, Kyle; Erhart, Kevin; Stanley, Henry; Nguyen, Bao-Ngoc T

    2015-01-01

    In proton therapy, passive scattered proton plans use compensators to conform the dose to the distal surface of the planning volume. These devices are custom made from acrylic or wax for each treatment field using either a plunge-drilled or smooth-milled compensator design. The purpose of this study was to investigate if there is a clinical benefit of generating passive scattered proton radiation treatment plans with the smooth compensator design. We generated 4 plans with different techniques using the smooth compensators. We chose 5 sites and 5 patients for each site for the range of dosimetric effects to show adequate sample. The plans were compared and evaluated using multicriteria (MCA) plan quality metrics for plan assessment and comparison using the Quality Reports [EMR] technology by Canis Lupus LLC. The average absolute difference for dosimetric metrics from the plunged-depth plan ranged from -4.7 to +3.0 and the average absolute performance results ranged from -6.6% to +3%. The manually edited smooth compensator plan yielded the best dosimetric metric, +3.0, and performance, + 3.0% compared to the plunged-depth plan. It was also superior to the other smooth compensator plans. Our results indicate that there are multiple approaches to achieve plans with smooth compensators similar to the plunged-depth plans. The smooth compensators with manual compensator edits yielded equal or better target coverage and normal tissue (NT) doses compared with the other smooth compensator techniques. Further studies are under investigation to evaluate the robustness of the smooth compensator design.

  4. Is there a clinical benefit with a smooth compensator design compared with a plunged compensator design for passive scattered protons?

    SciTech Connect

    Tabibian, Art A.; Powers, Adam; Dolormente, Keith; Oommen, Sneha; Tiwari, Akhil; Palmer, Matt; Zhu, Xiaorong R.; Li, Heng; Sahoo, Narayan; Wisdom, Paul; Velasco, Kyle; Erhart, Kevin; Stanley, Henry; Nguyen, Bao-Ngoc T.

    2015-04-01

    In proton therapy, passive scattered proton plans use compensators to conform the dose to the distal surface of the planning volume. These devices are custom made from acrylic or wax for each treatment field using either a plunge-drilled or smooth-milled compensator design. The purpose of this study was to investigate if there is a clinical benefit of generating passive scattered proton radiation treatment plans with the smooth compensator design. We generated 4 plans with different techniques using the smooth compensators. We chose 5 sites and 5 patients for each site for the range of dosimetric effects to show adequate sample. The plans were compared and evaluated using multicriteria (MCA) plan quality metrics for plan assessment and comparison using the Quality Reports [EMR] technology by Canis Lupus LLC. The average absolute difference for dosimetric metrics from the plunged-depth plan ranged from −4.7 to +3.0 and the average absolute performance results ranged from −6.6% to +3%. The manually edited smooth compensator plan yielded the best dosimetric metric, +3.0, and performance, + 3.0% compared to the plunged-depth plan. It was also superior to the other smooth compensator plans. Our results indicate that there are multiple approaches to achieve plans with smooth compensators similar to the plunged-depth plans. The smooth compensators with manual compensator edits yielded equal or better target coverage and normal tissue (NT) doses compared with the other smooth compensator techniques. Further studies are under investigation to evaluate the robustness of the smooth compensator design.

  5. Clinical inquiries. What are the risks and benefits of elective induction for uncomplicated term pregnancies?

    PubMed

    Santana, Wendis; Meyer, Albert; Flake, Donna; Neher, Jon O

    2006-11-01

    Elective induction of labor for term, singleton, uncomplicated pregnancies appears safe for both the mother and infant (strength of recommendation [SOR]: B). The benefit of elective induction for nonmedical reasons is unclear (SOR: B).

  6. 76 FR 1620 - Trials to Verify and Describe Clinical Benefit of Midodrine Hydrochloride; Establishment of...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-01-11

    ... to facilitate communication regarding the conduct of clinical trials needed to verify and describe...-threatening illnesses based on adequate and well-controlled clinical trials establishing that the drug has an... sponsored clinical trials and information regarding the drug's efficacy has been published, but...

  7. Evaluation of preceptors and skills achievement by clinical pharmacy clerkship students during their clinical rotations at University of Gondar, Ethiopia

    PubMed Central

    Belachew, Sewunet Admasu; Abegaz, Tadesse Melaku; Bhagavathula, Akshaya Srikanth; Getachew, Henok; Tefera, Yonas Getaye

    2016-01-01

    Aim To investigate the overall experiences of clinical pharmacy students during their clinical attachments and to understand the breadth and depth of clinical skills provided by their preceptors. Methods A cross-sectional study using a self-administered questionnaire containing 34 items to obtain feedback from the clerkship students from June to July 2015. Data analysis was performed to calculate mean, standard deviation, percentages, and multiple logistic regression using Statistical Package for the Social Sciences (SPSS) software Version 22. Statistical significance was set at P<0.01. Results All 58 clerkship students actively participated in the study, yielding a response rate of 100%. While students ranked their clerkship experience as moderate, >15% remarked that they did not receive enough opportunities to hone their pharmaceutical care documentation skills. A relatively high percentage of students (32.8%) strongly agreed that their preceptors had provided ample opportunity to discuss the patient problems at the bedside and encouraged them to express their opinions regarding patients’ drug therapeutic issues. This study also revealed that students’ continuity in developing their therapeutic and disease process knowledge was significantly associated with the preceptor’s ability to provide adequate training and orientation (P =0.01), engagement in clinical pharmacy activities (P =0.01), regular review of students’ work (P =0.01), and instruction to students before entering clinical sites (P =0.00). Conclusion The findings of this study reveal that a majority of the students were moderately satisfied with the clinical training program and preceptors need to demonstrate effective pharmaceutical care processes in their clinical sites. PMID:27099540

  8. A hybrid approach to achieving both marginal and conditional balances for stratification variables in sequential clinical trials.

    PubMed

    Lin, Yunzhi; Su, Zheng

    2013-01-01

    Various methods exist in the literature for achieving marginal balance for baseline stratification variables in sequential clinical trials. One major limitation with balancing on the margins of the stratification variables is that there is an efficiency loss when the primary analysis is stratified. To preserve the efficiency of a stratified analysis one recently proposed approach balances on the crossing of the stratification variables included in the analysis, which achieves conditional balance for the variables. A hybrid approach to achieving both marginal and conditional balances in sequential clinical trials is proposed, which is applicable to both continuous and categorical stratification variables. Numerical results based on extensive simulation studies and a real dataset show that the proposed approach outperforms the existing ones and is particularly useful when both additive and stratified models are planned for a trial.

  9. 'Makes you wanna do treatment': benefits of a hepatitis C specialist clinic to clients in Christchurch, New Zealand.

    PubMed

    Brener, Loren; Gray, Rebecca; Cama, Elena J; Treloar, Carla

    2013-03-01

    People with hepatitis C virus (HCV) are a marginalised population that may experience discrimination in everyday contexts, including health-care, due to the association of HCV with injecting drug use. Stigma and discrimination are known to have a range of negative effects on people with HCV, including diminished quality of life and avoidance of health-care. The Hepatitis C Community Clinic is an integrated care service established in 2008 in Christchurch, New Zealand to provide alternative access to health-care that is non-judgemental and supportive. As an integrated care service, the clinic aims to improve health outcomes and quality of life through a holistic approach to health-care for people with HCV and people who inject drugs. This qualitative study forms part of a broader mixed-methods evaluation of the clinic, and aims to assess the role of the clinic in improving health outcomes, knowledge, lifestyle practices and psychosocial functioning of the target population. Interviews were conducted with 24 health professionals and 24 clients of the clinic between April and November 2010. Findings illustrate that the clinic is a novel model of care that is effective in accessing a hard-to-reach and marginalised population in part due to the non-judgemental, caring and supportive environment that engenders trust with clients. Based on participant reports, the clinic assists clients in managing their HCV and other health concerns and in increasing their readiness for HCV treatment. Given the benefits of this community clinic to clients, it is proposed that future research investigate the feasibility and benefits of administering HCV treatment through community-based integrated care networks.

  10. Analysis, sample size, and power for estimating incremental net health benefit from clinical trial data.

    PubMed

    Willan, A R

    2001-06-01

    Stinnett and Mullahy recently introduced the concept of net health benefit as an alternative to cost-effectiveness ratios for the statistical analysis of patient-level data on the costs and health effects of competing interventions. Net health benefit addresses a number of problems associated with cost-effectiveness ratios by assuming a value for the willingness-to-pay for a unit of effectiveness. We extend the concept of net health benefit to demonstrate that standard statistical procedures can be used for the analysis, power, and sample size determinations of cost-effectiveness data. We also show that by varying the value of the willingness-to-pay, the point estimate and confidence interval for the incremental cost-effectiveness ratio can be determined. An example is provided.

  11. Paving the critical path: how can clinical pharmacology help achieve the vision?

    PubMed

    Lesko, L J

    2007-02-01

    It has been almost 3 years since the launch of the FDA critical path initiative following the publication of the paper "Innovation or Stagnation: Challenges and Opportunities on the Critical Path of New Medical Product Development." The initiative was intended to create an urgency with the drug development enterprise to address the so-called "productivity problem" in modern drug development. Clinical pharmacologists are strategically aligned with solutions designed to reduce late phase clinical trial failures to show adequate efficacy and/or safety. This article reviews some of the ways that clinical pharmacologists can lead and implement change in the drug development process. It includes a discussion of model-based, semi-mechanistic drug development, drug/disease models that facilitate informed clinical trial designs and optimal dosing, the qualification process and criteria for new biomarkers and surrogate endpoints, approaches to streamlining clinical trials and new types of interaction between industry and FDA such as the end-of-phase 2A and voluntary genomic data submission meetings respectively. PMID:17259944

  12. CTLA-4 blockade enhances polyfunctional NY-ESO-1 specific T cell responses in metastatic melanoma patients with clinical benefit.

    PubMed

    Yuan, Jianda; Gnjatic, Sacha; Li, Hao; Powel, Sarah; Gallardo, Humilidad F; Ritter, Erika; Ku, Geoffrey Y; Jungbluth, Achim A; Segal, Neil H; Rasalan, Teresa S; Manukian, Gregor; Xu, Yinyan; Roman, Ruth-Ann; Terzulli, Stephanie L; Heywood, Melanie; Pogoriler, Evelina; Ritter, Gerd; Old, Lloyd J; Allison, James P; Wolchok, Jedd D

    2008-12-23

    Blockade of inhibitory signals mediated by cytotoxic T lymphocyte-associated antigen 4 (CTLA-4) has been shown to enhance T cell responses and induce durable clinical responses in patients with metastatic melanoma. The functional impact of anti-CTLA-4 therapy on human immune responses is still unclear. To explore this, we analyzed immune-related adverse events and immune responses in metastatic melanoma patients treated with ipilimumab, a fully human anti-CTLA-4 monoclonal antibody. Fifteen patients were selected on the basis of availability of suitable specimens for immunologic monitoring, and eight of these showed evidence of clinical benefit. Five of the eight patients with evidence of clinical benefit had NY-ESO-1 antibody, whereas none of seven clinical non-responders was seropositive for NY-ESO-1. All five NY-ESO-1 seropositive patients had clearly detectable CD4(+) and CD8(+) T cells against NY-ESO-1 following treatment with ipilimumab. One NY-ESO-1 seronegative clinical responder also had a NY-ESO-1 CD4(+) and CD8(+) T cell response, possibly related to prior vaccination with NY-ESO-1. Among five clinical non-responders analyzed, only one had a NY-ESO-1 CD4(+) T cell response and this patient did not have detectable anti-NY-ESO-1 antibody. Overall, NY-ESO-1-specific T cell responses increased in frequency and functionality during anti-CTLA-4 treatment, revealing a polyfunctional response pattern of IFN-gamma, MIP-1beta and TNF-alpha. We therefore suggest that CTLA-4 blockade enhanced NY-ESO-1 antigen-specific B cell and T cell immune responses in patients with durable objective clinical responses and stable disease. These data provide an immunologic rationale for the efficacy of anti-CTLA-4 therapy and call for immunotherapeutic designs that combine NY-ESO-1 vaccination with CTLA-4 blockade.

  13. Randomization in clinical trials in orthodontics: its significance in research design and methods to achieve it.

    PubMed

    Pandis, Nikolaos; Polychronopoulou, Argy; Eliades, Theodore

    2011-12-01

    Randomization is a key step in reducing selection bias during the treatment allocation phase in randomized clinical trials. The process of randomization follows specific steps, which include generation of the randomization list, allocation concealment, and implementation of randomization. The phenomenon in the dental and orthodontic literature of characterizing treatment allocation as random is frequent; however, often the randomization procedures followed are not appropriate. Randomization methods assign, at random, treatment to the trial arms without foreknowledge of allocation by either the participants or the investigators thus reducing selection bias. Randomization entails generation of random allocation, allocation concealment, and the actual methodology of implementing treatment allocation randomly and unpredictably. Most popular randomization methods include some form of restricted and/or stratified randomization. This article introduces the reasons, which make randomization an integral part of solid clinical trial methodology, and presents the main randomization schemes applicable to clinical trials in orthodontics.

  14. Relationships between Preferred Learning and Clinical Achievement of Baccalaureate Nursing Students.

    ERIC Educational Resources Information Center

    Wilkerson, Norma Neahr

    Paper presented at the Regional achievement in a nursing course in an integrated curriculum were studied. The theoretical framework was based on Kolb's model of experiential learning, which posited four phases: concrete experience, reflective observation, abstract conceptualization, and active experimentation. Kolb's Learning Style Inventory was…

  15. Worms as therapeutic agents for allergy and asthma: understanding why benefits in animal studies have not translated into clinical success.

    PubMed

    Evans, Holly; Mitre, Edward

    2015-02-01

    Helminth infections are associated with decreased rates of autoimmunity and allergy, and several clinical studies have demonstrated that intentional infection with helminths can reduce symptoms of autoimmune diseases. In contrast, though numerous animal studies have demonstrated that helminth infections ameliorate allergic diseases, clinical trials in humans have not shown benefit. In this article, we review in detail the 2 human studies that have prospectively tested whether helminth infections protect against allergy. We next review the research designs and results obtained from animal studies, and compare these to the human trials. We then postulate possible reasons for the lack of efficacy observed in clinical trials to date and discuss potential future areas of research in this field.

  16. Clinical Observations About the Potential Benefits and Pitfalls of Between-Session Contacts with Borderline Patients.

    PubMed

    Jacob, Karen L

    2016-01-01

    Borderline Personality Disorder (BPD) has a reputation for being a challenging disorder to treat due to the nature of the illness. With the development of evidence-based treatments, therapists are becoming more skilled at successfully helping this cohort of patients. A common factor associated with all validated treatments for BPD is the active involvement of therapists. For example, DBT is one treatment where therapists are expected to be available to patients for coaching outside of sessions. However, understanding the benefits and pitfalls associated with therapists' accessibility in between sessions is relevant to any treatment with intersession contact. In this article, three benefits of intersession contact are described: to generalize the use of skills, to improve understanding of the patient's needs, and to facilitate an alliance. This article also addresses the pitfalls of therapists being so accessible to patients. Both the benefits and pitfalls of intersession contact are illustrated using case vignettes. Assessing the function served by a patient's contact in between sessions is an important way to determine whether such contact is a productive part of treatment. Recommendations are provided to avoid detrimental outcomes for both the therapist (therapist burnout) and the patient. PMID:27603746

  17. Clinical benefits of tight glycaemic control: focus on the perioperative setting.

    PubMed

    Furnary, Anthony P

    2009-12-01

    The benefits of tight glycaemic control (TGC) were first shown in cardiac surgical patients with diabetes. These concepts migrated to other surgical and medical specialties through intensive care units caring for a variety of patients with a variety of disease states Although some disagreement and controversy surrounds the use of TGC in the medical population, the benefits of this therapy ir the diabetes cardiac surgery population is unblemished. Perioperative hyperglycaemia has been shown to be associated with adverse surgical outcomes in several different patient populations TGC for 3 full postoperative days or more mitigates these risks Although this has been definitively proven in the diabetes coronary artery bypass graft (CABG) population, evidence for beneficia effects of TGC in other surgical populations remains elusive at this point in time. In this article, we explore the risks of hyper- and hypoglycaemia in the surgical patient; safety and efficacy of insulin protocols in the surgical population, target range goals and dura tion of therapy; the beneficial effects of TGC on decreasing mortality, reducing infectious complications, length of stay and other complications; define target surgical populations tha benefit from TGC; analyse current controversies as they relate to surgical populations; and describe questions that remain for the future of TGC.

  18. Weighing the evidence: risks and benefits of participatory documentary in corporatized clinics.

    PubMed

    Hansen, Helena

    2013-12-01

    This paper describes the effects of one U.S.-based public psychiatry clinic's shift to a centralized, corporate style of management, in response to pressures to cut expenditures by focusing on "evidence based" treatments. Participant observation research conducted between 2008 and 2012 for a larger study involving 127 interviews with policy makers, clinic managers, clinical practitioners and patients revealed that the shift heralded the decline of arts based therapies in the clinic, and of the social networks that had developed around them. It also inspired a participatory video self-documentary project among art group members, to portray the importance of arts-based therapies and garner public support for such therapies. Group members found a way to take action in the face of unilateral decision making, but experienced subsequent restrictions on clinic activities and discharge of core members from the clinic. The paper ends with a discussion of biopolitics, central legibility through corporate standardization, and the potential and risks of participatory documentaries to resist these trends. PMID:23932854

  19. Weighing the evidence: risks and benefits of participatory documentary in corporatized clinics.

    PubMed

    Hansen, Helena

    2013-12-01

    This paper describes the effects of one U.S.-based public psychiatry clinic's shift to a centralized, corporate style of management, in response to pressures to cut expenditures by focusing on "evidence based" treatments. Participant observation research conducted between 2008 and 2012 for a larger study involving 127 interviews with policy makers, clinic managers, clinical practitioners and patients revealed that the shift heralded the decline of arts based therapies in the clinic, and of the social networks that had developed around them. It also inspired a participatory video self-documentary project among art group members, to portray the importance of arts-based therapies and garner public support for such therapies. Group members found a way to take action in the face of unilateral decision making, but experienced subsequent restrictions on clinic activities and discharge of core members from the clinic. The paper ends with a discussion of biopolitics, central legibility through corporate standardization, and the potential and risks of participatory documentaries to resist these trends.

  20. [Tissue regeneration strategies: cells, biochemical inductors, bionanomaterials and bioconstructions. Clinical and surgical achievements].

    PubMed

    Valdespino-Gómez, Víctor Manuel; Valdespino-Castillo, Patricia Margarita; Valdespino-Castillo, Víctor Edmundo

    2014-01-01

    Regenerative medicine is a medical multidisciplinary area with the aim of morphologic and functional restoration of tissues or organs in order to re-establish normal function. The main bases of regenerative medicine are the use of autologous stem or progenitor cells and the ex vivo construction of physical-mechanical tissue structuring organization, which with stem cells may form bioartificial organs. Another eventual strategy is in vivo stem or progenitor cell stimulation for proliferation. Tissue engineering entirely combines the use of cells, biochemical and physicochemical factors, nanomaterials and bioengineering methods to improve or replace biological functions of tissues and organs. The progressive understanding of the proliferation and differentiation of the process of stem cells and their in vitro manipulation has been the launching platform for the field of regenerative medicine. In this review we describe the main strategies used for regenerative medicine in tissue regeneration along with the main obtained clinicalsurgical benefits.

  1. [Tissue regeneration strategies: cells, biochemical inductors, bionanomaterials and bioconstructions. Clinical and surgical achievements].

    PubMed

    Valdespino-Gómez, Víctor Manuel; Valdespino-Castillo, Patricia Margarita; Valdespino-Castillo, Víctor Edmundo

    2014-01-01

    Regenerative medicine is a medical multidisciplinary area with the aim of morphologic and functional restoration of tissues or organs in order to re-establish normal function. The main bases of regenerative medicine are the use of autologous stem or progenitor cells and the ex vivo construction of physical-mechanical tissue structuring organization, which with stem cells may form bioartificial organs. Another eventual strategy is in vivo stem or progenitor cell stimulation for proliferation. Tissue engineering entirely combines the use of cells, biochemical and physicochemical factors, nanomaterials and bioengineering methods to improve or replace biological functions of tissues and organs. The progressive understanding of the proliferation and differentiation of the process of stem cells and their in vitro manipulation has been the launching platform for the field of regenerative medicine. In this review we describe the main strategies used for regenerative medicine in tissue regeneration along with the main obtained clinicalsurgical benefits. PMID:25259440

  2. Nuclear imaging of the breast: Translating achievements in instrumentation into clinical use

    PubMed Central

    Hruska, Carrie B.; O'Connor, Michael K.

    2013-01-01

    Approaches to imaging the breast with nuclear medicine and/or molecular imaging methods have been under investigation since the late 1980s when a technique called scintimammography was first introduced. This review charts the progress of nuclear imaging of the breast over the last 20 years, covering the development of newer techniques such as breast specific gamma imaging, molecular breast imaging, and positron emission mammography. Key issues critical to the adoption of these technologies in the clinical environment are discussed, including the current status of clinical studies, the efforts at reducing the radiation dose from procedures associated with these technologies, and the relevant radiopharmaceuticals that are available or under development. The necessary steps required to move these technologies from bench to bedside are also discussed. PMID:23635248

  3. Nuclear imaging of the breast: Translating achievements in instrumentation into clinical use

    SciTech Connect

    Hruska, Carrie B.; O'Connor, Michael K.

    2013-05-15

    Approaches to imaging the breast with nuclear medicine and/or molecular imaging methods have been under investigation since the late 1980s when a technique called scintimammography was first introduced. This review charts the progress of nuclear imaging of the breast over the last 20 years, covering the development of newer techniques such as breast specific gamma imaging, molecular breast imaging, and positron emission mammography. Key issues critical to the adoption of these technologies in the clinical environment are discussed, including the current status of clinical studies, the efforts at reducing the radiation dose from procedures associated with these technologies, and the relevant radiopharmaceuticals that are available or under development. The necessary steps required to move these technologies from bench to bedside are also discussed.

  4. Achieving clinical statement interoperability using R-MIM and archetype-based semantic transformations.

    PubMed

    Kilic, Ozgur; Dogac, Asuman

    2009-07-01

    Effective use of electronic healthcare records (EHRs) has the potential to positively influence both the quality and the cost of health care. Consequently, sharing patient's EHRs is becoming a global priority in the healthcare information technology domain. This paper addresses the interoperability of EHR structure and content. It describes how two different EHR standards derived from the same reference information model (RIM) can be mapped to each other by using archetypes, refined message information model (R-MIM) derivations, and semantic tools. It is also demonstrated that well-defined R-MIM derivation rules help tracing the class properties back to their origins when the R-MIMs of two EHR standards are derived from the same RIM. Using well-defined rules also enable finding equivalences in the properties of the source and target EHRs. Yet an R-MIM still defines the concepts at the generic level. Archetypes (or templates), on the other hand, constrain an R-MIM to domain-specific concepts, and hence, provide finer granularity semantics. Therefore, while mapping clinical statements between EHRs, we also make use of the archetype semantics. Derivation statements are inferred from the Web Ontology Language definitions of the RIM, the R-MIMs, and the archetypes. Finally, we show how to transform Health Level Seven clinical statement instances to EHRcom clinical statement instances and vice versa by using the generated mapping definitions.

  5. Comprehensive cancer-gene panels can be used to estimate mutational load and predict clinical benefit to PD-1 blockade in clinical practice.

    PubMed

    Campesato, Luís Felipe; Barroso-Sousa, Romualdo; Jimenez, Leandro; Correa, Bruna R; Sabbaga, Jorge; Hoff, Paulo M; Reis, Luiz F L; Galante, Pedro Alexandre F; Camargo, Anamaria A

    2015-10-27

    Cancer gene panels (CGPs) are already used in clinical practice to match tumor's genetic profile with available targeted therapies. We aimed to determine if CGPs could also be applied to estimate tumor mutational load and predict clinical benefit to PD-1 and CTLA-4 checkpoint blockade therapy. Whole-exome sequencing (WES) mutation data obtained from melanoma and non-small cell lung cancer (NSCLC) patients published by Snyder et al. 2014 and Rizvi et al. 2015, respectively, were used to select nonsynonymous somatic mutations occurring in genes included in the Foundation Medicine Panel (FM-CGP) and in our own Institutional Panel (HSL-CGP). CGP-mutational load was calculated for each patient using both panels and was associated with clinical outcomes as defined and reported in the original articles. Higher CGP-mutational load was observed in NSCLC patients presenting durable clinical benefit (DCB) to PD-1 blockade (FM-CGP P=0.03, HSL-CGP P=0.01). We also observed that 69% of patients with high CGP-mutational load experienced DCB to PD-1 blockade, as compared to 20% of patients with low CGP-mutational load (FM-CGP and HSL-CGP P=0.01). Noteworthy, predictive accuracy of CGP-mutational load for DCB was not statistically different from that estimated by WES sequencing (P=0.73). Moreover, a high CGP-mutational load was significantly associated with progression-free survival (PFS) in patients treated with PD-1 blockade (FM-CGP P=0.005, HR 0.27, 95% IC 0.105 to 0.669; HSL-CGP P=0.008, HR 0.29, 95% IC 0.116 to 0.719). Similar associations between CGP-mutational load and clinical benefit to CTLA-4 blockade were not observed. In summary, our data reveals that CGPs can be used to estimate mutational load and to predict clinical benefit to PD-1 blockade, with similar accuracy to that reported using WES. PMID:26439694

  6. Comprehensive cancer-gene panels can be used to estimate mutational load and predict clinical benefit to PD-1 blockade in clinical practice

    PubMed Central

    Campesato, Luís Felipe; Barroso-Sousa, Romualdo; Jimenez, Leandro; Correa, Bruna R.; Sabbaga, Jorge; Hoff, Paulo M.; Reis, Luiz F. L.; Galante, Pedro Alexandre F.; Camargo, Anamaria A.

    2015-01-01

    Cancer gene panels (CGPs) are already used in clinical practice to match tumor's genetic profile with available targeted therapies. We aimed to determine if CGPs could also be applied to estimate tumor mutational load and predict clinical benefit to PD-1 and CTLA-4 checkpoint blockade therapy. Whole-exome sequencing (WES) mutation data obtained from melanoma and non-small cell lung cancer (NSCLC) patients published by Snyder et al. 2014 and Rizvi et al. 2015, respectively, were used to select nonsynonymous somatic mutations occurring in genes included in the Foundation Medicine Panel (FM-CGP) and in our own Institutional Panel (HSL-CGP). CGP-mutational load was calculated for each patient using both panels and was associated with clinical outcomes as defined and reported in the original articles. Higher CGP-mutational load was observed in NSCLC patients presenting durable clinical benefit (DCB) to PD-1 blockade (FM-CGP P=0.03, HSL-CGP P=0.01). We also observed that 69% of patients with high CGP-mutational load experienced DCB to PD-1 blockade, as compared to 20% of patients with low CGP-mutational load (FM-CGP and HSL-CGP P=0.01). Noteworthy, predictive accuracy of CGP-mutational load for DCB was not statistically different from that estimated by WES sequencing (P=0.73). Moreover, a high CGP-mutational load was significantly associated with progression-free survival (PFS) in patients treated with PD-1 blockade (FM-CGP P=0.005, HR 0.27, 95% IC 0.105 to 0.669; HSL-CGP P=0.008, HR 0.29, 95% IC 0.116 to 0.719). Similar associations between CGP-mutational load and clinical benefit to CTLA-4 blockade were not observed. In summary, our data reveals that CGPs can be used to estimate mutational load and to predict clinical benefit to PD-1 blockade, with similar accuracy to that reported using WES. PMID:26439694

  7. Maximize the benefit of SNCR: Combine SNCR with combustion optimization and achieve 50% NOx reduction from a low NOx burner baseline

    SciTech Connect

    Trego, P.; Schindler, E.

    2000-07-01

    PECO Energy Company operates one coal fired boiler at its Cromby Generating Facility. Cromby Unit 1 is a B and W front fired unit rated at 160 MW. The units boiler has been retrofitted with low NOx burners and overfire air ports. Due to NOx allowance pricing, PECO began evaluating options for reducing Cromby's NOx emissions. SNCR was evaluated at the best option for the plant even though the furnace exit temperatures and CO were high at practical injection locations. RJM Corporation, a Fuel Tech NOxOUT{trademark} Implementer, was selected to supply the system because of their extensive experience in solving combustion problems and applying NOxOUT SNCR systems on utility boilers. In order to reduce emissions during the 1999 NOx season, the deadline for an operational system was set at June 2nd. The project was issued on a fast track schedule starting February 2, 1999. The boiler was started up on June 2 on schedule after a six week maintenance outage. The project's 25% NOx reduction target was achieved after two weeks of combustion optimization. Combustion optimization was followed by NOxOUT A reagent injection system optimization which resulted in a 50% combined NOx reduction. Other benefits included a reduction in CO to less than 100 ppm and a 33% reduction in LOI.

  8. Achieving collaboration in ethical decision making: strategies for nurses in clinical practice.

    PubMed

    Wocial, L D

    1996-01-01

    Ethical decision making is a process that combines justice and caring in moral reflection to select sound choices. Nurses and physicians often have different perspectives on how to resolve ethical dilemmas. Satisfactory resolution depends on overcoming conflict and achieving collaboration between members of the health care team. Conflict can occur on a number of different levels. For example, it can be between nurses, nurses and physicians or the entire health care team and the patient. This article helps prepare critical care nurses to handle ethical dilemmas in crisis situations by providing them with specific strategies that help promote collaboration in resolving ethical dilemmas. PMID:8715871

  9. Weighing the evidence: Risks and benefits of participatory documentary in corporatized clinics

    PubMed Central

    Hansen, Helena

    2014-01-01

    This paper describes the effects of one U.S.-based public psychiatry clinic’s shift to a centralized, corporate style of management, in response to pressures to cut expenditures by focusing on “evidence based” treatments. Participant observation research conducted between 2008 and 2012 for a larger study involving 127 interviews with policy makers, clinic managers, clinical practitioners and patients revealed that the shift heralded the decline of arts based therapies in the clinic, and of the social networks that had developed around them. It also inspired a participatory video self-documentary project among art group members, to portray the importance of arts-based therapies and garner public support for such therapies. Group members found a way to take action in the face of unilateral decision making, but experienced subsequent restrictions on clinic activities and discharge of core members from the clinic. The paper ends with a discussion of biopolitics, central legibility through corporate standardization, and the potential and risks of participatory documentaries to resist these trends. PMID:23932854

  10. Innovations in Total Knee Arthroplasty: Improved Technical Precision, But Unclear Clinical Benefits.

    PubMed

    Keeney, James A

    2016-07-01

    Total knee arthroplasty has been an effective treatment for advanced degenerative joint disease. Traditional knee designs and surgical approaches have resulted in consistently high performance, but some patients may remain dissatisfied after their surgery. Several surgical innovations, including accelerometer-based navigation, patient-specific instrumentation, and robotic-assisted total knee arthroplasty, have been developed to improve the accuracy and precision of total knee arthroplasty surgery, with anticipated secondary benefits of improved functional outcomes and implant survivorship. This article reviews the current status of these technologies as reported in contemporary orthopedic literature. [Orthopedics. 2016; 39(4):217-220.]. PMID:27434889

  11. Nutrition and education. IV. Clinical signs of malnutrition and its relationship with socioeconomic, anthropometric, dietetic and educational achievement parameters.

    PubMed

    Ivanovic Marincovich, D

    1992-03-01

    The objective of this study was to determine the prevalence of clinical signs of malnutrition, and to measure the interrelationship with socioeconomic, anthropometric, dietetic and educational achievement parameters. A random sample of 550 Chilean elementary and high school graduates (1:1), of both sexes (1:1), from public and private schools (1:1) and from high, medium and low socioeconomic status (SES) (1:1:1), was chosen in the Metropolitan Area of Santiago, Chile. SES was measured through the Graffar Modified Scale. Clinical signs of malnutrition were assessed according to Jelliffe. Nutritional status was determined by means of anthropometric measurements: percentages of weight/age (W/A), height/age (H/A) and weight for height (W/H) were compared with the WHO Tables; head circumference/age (HC/A) with the Tanner Tables, and branchial anthropometric parameters by applying the Frisancho norms. Standard procedures for the 24 hour dietary recall interviews were used to collect data, and adequacy of intake was assessed by the FAO/WHO pattern. Educational achievement (EA) was measured through the Achievement Evaluation Program, (AEP) and Academic Aptitude Test (AAT) in elementary and high school graduates, respectively. Results showed that apart from caries (87.5%), most prevalent clinical signs of malnutrition were dermatosis (13.4%), follicular hyperkeratosis type I (13.2%), nasolabial dyssebacea (7.9%), lustreless hair (7.7%), angular stomatitis (4.4%) and cheilosis (2.7%). The number of clinical signs of malnutrition was found inversely and significantly associated with SES, H/A, vitamin A and calcium intake, as well as with EA, besides registering a lower nutrient intake, specially for energy, riboflavin and niacin.(ABSTRACT TRUNCATED AT 250 WORDS)

  12. Benefit-risk paradigm for clinical trial design of obesity devices: FDA proposal.

    PubMed

    Lerner, Herbert; Whang, Joyce; Nipper, Rebecca

    2013-03-01

    Diet and exercise, except in controlled circumstances, have not been shown to provide effective and prolonged weight loss for the majority of those who are obese. Several older drugs intended to reduce weight have been withdrawn from the market, and the new drugs show only modest weight loss. Surgical intervention, specifically procedures that alter the normal gastrointestinal anatomy, does provide prolonged periods of sustained weight loss, with rebound weight gain over time. A variety of medical devices to assist in weight reduction have been studied, but only two are legally marketed devices for obesity. The authors propose a new paradigm for devices intended to treat obesity, based on a benefit-risk determination, with the hope to provide sponsors an a priori tool for systematic assessment of the risks associated with the devices intended for treatment of obesity and to suggest appropriate levels of benefit for devices with different risk levels. The paradigm is not intended to determine the class of a device from a regulatory perspective. This approach was conceived at a Food and Drug Administration (FDA) co-sponsored workshop in October, 2011 and formally presented to an FDA advisory panel for discussion in May 2012.

  13. Clinical benefits and immunopathological correlates of intravenous immune globulin in the treatment of inflammatory myopathies.

    PubMed

    Dalakas, M C

    1996-05-01

    High-dose intravenous immune globulin (IVIG) is emerging as a promising therapy for patients with inflammatory myopathies who have become unresponsive to, or cannot tolerate, conventional therapies. In a double-blind, placebo-controlled study, using objective criteria for improvement, IVIG demonstrated moderate to dramatic improvement in 75% of the patients with dermatomyositis. Preliminary results from a controlled study in inclusion-body myositis show that IVIG may also exert a mild benefit, but only in a small number of patients and in certain muscle groups. In some patients with polymyositis, IVIG is reported to be of benefit but controlled studies have not yet been completed. Immunocytochemical, immunological and in vitro studies on the patients' repeated muscle biopsies and follow-up sera showed that IVIG exerts its action in inflammatory myopathies by: (i) inhibiting myotoxic cytokines, such as TNF-alpha and IL-1; (ii) blockade of Fc receptors on endomysial macrophages interfering with Fc receptor-mediated phagocytosis; and (iii) inhibiting the uptake of C3 and intercepting the formation and deposition of membranolytic attack complex on the endomysial capillaries.

  14. Towards Achieving the Full Clinical Potential of Proton Therapy by Inclusion of LET and RBE Models

    PubMed Central

    Jones, Bleddyn

    2015-01-01

    Despite increasing use of proton therapy (PBT), several systematic literature reviews show limited gains in clinical outcomes, with publications mostly devoted to recent technical developments. The lack of randomised control studies has also hampered progress in the acceptance of PBT by many oncologists and policy makers. There remain two important uncertainties associated with PBT, namely: (1) accuracy and reproducibility of Bragg peak position (BPP); and (2) imprecise knowledge of the relative biological effect (RBE) for different tissues and tumours, and at different doses. Incorrect BPP will change dose, linear energy transfer (LET) and RBE, with risks of reduced tumour control and enhanced toxicity. These interrelationships are discussed qualitatively with respect to the ICRU target volume definitions. The internationally accepted proton RBE of 1.1 was based on assays and dose ranges unlikely to reveal the complete range of RBE in the human body. RBE values are not known for human (or animal) brain, spine, kidney, liver, intestine, etc. A simple efficiency model for estimating proton RBE values is described, based on data of Belli et al. and other authors, which allows linear increases in α and β with LET, with a gradient estimated using a saturation model from the low LET α and β radiosensitivity parameter input values, and decreasing RBE with increasing dose. To improve outcomes, 3-D dose-LET-RBE and bio-effectiveness maps are required. Validation experiments are indicated in relevant tissues. Randomised clinical studies that test the invariant 1.1 RBE allocation against higher values in late reacting tissues, and lower tumour RBE values in the case of radiosensitive tumours, are also indicated. PMID:25790470

  15. Cardiovascular benefits of probiotics: a review of experimental and clinical studies.

    PubMed

    Thushara, Ram Mohan; Gangadaran, Surendiran; Solati, Zahra; Moghadasian, Mohammed H

    2016-02-01

    The microbiota inhabiting the human gastro-intestinal tract is reported to have a significant impact on the health of an individual. Recent findings suggest that the microbial imbalance of the gut may play a role in pathogenesis of cardiovascular diseases (CVD). Therefore, several studies have delved into the aspect of altering gut microbiota with probiotics as an approach to prevent and/or treat CVD. The World Health Organization defines probiotics as live microorganisms that, when consumed in adequate amounts, have a positive influence on the individual's health. The present review focuses on strategies of human dietary intervention with probiotic strains and their impact on cardiovascular risk factors like hypercholesterolemia, hypertension, obesity and type-2 diabetes. Accumulating evidence shows probiotics to lower low density lipoproteins (LDL)-cholesterol and improve the LDL/high density lipoproteins (HDL) ratio, as well as lower blood pressure, inflammatory mediators, blood glucose levels and body mass index. Thus, probiotics have the scope to be developed as dietary supplements with potential cardiovascular health benefits. However, there is not only ambiguity regarding the exact strains and dosages of the probiotics that will bring about positive health effects, but also factors like immunity and genetics of the individual that might influence the efficacy of probiotics. Therefore, further studies are required not only to understand the mechanisms by which probiotics may beneficially affect the cardiovascular system, but also to rule out any of their probable negative effects on health. The present review aims to critically appraise the complexity of the available data with regard to the cardiovascular benefits of probiotics. PMID:26786971

  16. Review of endoscopic radiofrequency in biliopancreatic tumours with emphasis on clinical benefits, controversies and safety

    PubMed Central

    Alvarez-Sánchez, María-Victoria; Napoléon, Bertrand

    2016-01-01

    Most pancreatic cancers and extrahepatic cholangiocarcinomas are unresectable at the time of diagnosis, and even in case of a resectable cancer, for elderly or patients with coexistent comorbidities, surgery is not an option. Current treatment alternatives in these scenarios are very limited. Biliary stenting with self-expanding metal stents (SEMS) is the mainstay palliative treatment of biliary obstruction due to unresectable pancreatic cancer or cholangiocarcinoma. Nevertheless, more than 50% of SEMS become occluded after 6 mo due to tumour over- and ingrowth, leading to hospital readmissions and reinterventions that significantly impair quality of life. Regimes of chemotherapy or chemoradiotherapy also provide minimal survival benefits. Therefore, novel therapies are eagerly awaited. Radiofrequency (RF) energy causes coagulative necrosis leading to local destruction of the accessed malignant tissue and has an established role in the treatment of malignancies in several solid organs, especially liver cancers. However, pancreatic and extrahepatic biliary cancers are not easily accessed by a percutaneous route, making the procedure dangerous. Over the past five years, the development of dedicated devices compatible with endoscopic instruments has offered a minimally invasive option for RF energy delivery in biliopancreatic cancers. Emerging experience with endoscopic RF ablation (RFA) in this setting has been reported in the literature, but little is known about its feasibility, efficacy and safety. A literature review makes it clear that RFA in biliopancreatic tumours is feasible with high rates of technical success and acceptable safety profile. Although available data suggest a benefit of survival with RFA, there is not enough evidence to draw a firm conclusion about its efficacy. For this reason, prospective randomized trials comparing RFA with standard palliative treatments with quality-of-life and survival endpoints are required. Anecdotal reports have also

  17. Who benefits most from THC:CBD spray? Learning from clinical experience.

    PubMed

    Koehler, Jürgen

    2014-01-01

    Patients with multiple sclerosis (MS) represent a diverse and heterogeneous population varying in terms of disease type, its severity and variable progression/time-course, and with regard to the wide range of presenting symptoms. Consequently, detailed experience with individual patients is important to provide examples of therapy to specific patient types. In this article, real-life data from clinical practice showing specific aspects relating to use of 9-delta-tetrahydocannabinol and cannabidiol (THC:CBD) oromucosal spray (Sativex®) in patients with moderate to severe spasticity resistant to usual therapy will be presented. Three common clinical scenarios will be considered: MS patients with resistance to usual spasticity therapies; patients with impairment in MS spasticity symptoms; MS patients with relevant impairment in quality of life/activities of daily living (QoL/ADL). These case reports highlight the diverse nature of the MS spasticity population and they show the possible usefulness of THC:CBD oromucosal spray in individual patients with moderate to severe spasticity resistant to existing therapies, within the frame of use approved after large clinical trial results. Perhaps the most important finding is the possibility of obtaining relevant improvements in QoL/ADL in some patients with resistant MS spasticity, allowing them to engage back in physical and social activities. PMID:24457847

  18. Early Benefit Assessments in Oncology in Germany: How Can a Clinically Relevant Endpoint Not Be Relevant to Patients?

    PubMed

    Ruof, Jörg; Flückiger, Olivier; Andre, Niko

    2015-09-01

    After 4 years of early benefit assessment (EBA) in Germany, it is becoming evident that the Federal Joint Committee (FJC) frequently considers well-established clinical endpoints as not being relevant to patients. Focusing on assessments of oncology medicines, we analysed the FJC's view on primary endpoints and compared it with the approach used by regulatory authorities. Mortality data were accepted by both stakeholders. Whereas regulatory authorities accepted primary morbidity endpoints such as progression-free survival and response rates, the FJC mostly excluded these from its assessments. Health-related quality of life (HRQoL) data have been poorly reflected in the approval process; for EBAs, those data have rarely impacted on benefit ratings. We argue that agreement between regulatory authorities and the FJC is required regarding primary study endpoints that are relevant to patients, and that clarification of acceptable endpoints by the FJC, especially in the morbidity domain, has to be provided. Moreover, in order to fully acknowledge the benefit of a new medicinal product, mortality, morbidity and HRQoL should be weighted differentially, according to the condition. PMID:26286202

  19. A four gene signature predicts benefit from anthracyclines: evidence from the BR9601 and MA.5 clinical trials.

    PubMed

    Spears, Melanie; Yousif, Fouad; Lyttle, Nicola; Boutros, Paul C; Munro, Alison F; Twelves, Chris; Pritchard, Kathleen I; Levine, Mark N; Shepherd, Lois; Bartlett, John M S

    2015-10-13

    Chromosome instability (CIN) in solid tumours results in multiple numerical and structural chromosomal aberrations and is associated with poor prognosis in multiple tumour types. Recent evidence demonstrated CEP17 duplication, a CIN marker, is a predictive marker of anthracycline benefit. An analysis of the BR9601 and MA.5 clinical trials was performed to test the role of existing CIN gene expression signatures as predictive markers of anthracycline sensitivity in breast cancer. Univariate analysis demonstrated, high CIN25 expression score was associated with improved distant relapse free survival (DRFS) (HR: 0.74, 95% CI 0.54-0.99, p = 0.046). High tumour CIN70 and CIN25 scores were associated with aggressive clinicopathological phenotype and increased sensitivity to anthracycline therapy compared to low CIN scores. However, in a prospectively planned multivariate analysis only pathological grade, nodal status and tumour size were significant predictors of outcome for CIN25/CIN70. A limited gene signature was generated, patients with low tumour CIN4 scores benefited from anthracycline treatment significantly more than those with high CIN4 scores (HR 0.37, 95% CI 0.20-0.56, p = 0.001). In multivariate analyses the treatment by marker interaction for CIN4/anthracyclines demonstrated hazard ratio of 0.35 (95% CI 0.15-0.80, p = 0.012) for DRFS. This data shows CIN4 is independent predictor of anthracycline benefit for DRFS in breast cancer.

  20. Fostering Dental Students' Academic Achievements and Reflection Skills Through Clinical Peer Assessment and Feedback.

    PubMed

    Tricio, Jorge A; Woolford, Mark J; Escudier, Michael P

    2016-08-01

    Peer assessment is increasingly being encouraged to enhance dental students' learning. The aim of this study was to evaluate the educational impact in terms of academic achievements and reflective thinking of a formative prospective peer assessment and feedback protocol. Volunteer final-year dental students at King's College London Dental Institute, UK, received training on peer assessment, peer feedback, and self-reflection. At the beginning (baseline) and end (resultant) of the 2012-13 academic year, 86 students (55% of the year group) completed a reflection questionnaire (RQ). Sixty-eight of those students used a modified Direct Observation of Procedural Skills (DOPS) as a framework for peer assessment and peer feedback during a complete academic year. End-of-year, high-stakes examination grades and RQ scores from the participants and nonparticipants were statistically compared. The participants completed 576 peer DOPS. Those 22 students who peer assessed each other ≥10 times exhibited highly statistically significant differences and powerful positive effect sizes in their high-stakes exam grades (p=0.0001, d=0.74) and critical reflection skills (p=0.005, d=1.41) when compared to those who did not assess one another. Furthermore, only the same 22 students showed a statistically significant increase and positive effect size in their critical reflection skills from baseline to resultant (p=0.003, d=1.04). The results of this study suggest that the protocol used has the potential to impact dental students' academic and reflection skills, provided it is practiced in ten or more peer encounters and ensuring peer feedback is provided followed by self-reflection. PMID:27480702

  1. Fostering Dental Students' Academic Achievements and Reflection Skills Through Clinical Peer Assessment and Feedback.

    PubMed

    Tricio, Jorge A; Woolford, Mark J; Escudier, Michael P

    2016-08-01

    Peer assessment is increasingly being encouraged to enhance dental students' learning. The aim of this study was to evaluate the educational impact in terms of academic achievements and reflective thinking of a formative prospective peer assessment and feedback protocol. Volunteer final-year dental students at King's College London Dental Institute, UK, received training on peer assessment, peer feedback, and self-reflection. At the beginning (baseline) and end (resultant) of the 2012-13 academic year, 86 students (55% of the year group) completed a reflection questionnaire (RQ). Sixty-eight of those students used a modified Direct Observation of Procedural Skills (DOPS) as a framework for peer assessment and peer feedback during a complete academic year. End-of-year, high-stakes examination grades and RQ scores from the participants and nonparticipants were statistically compared. The participants completed 576 peer DOPS. Those 22 students who peer assessed each other ≥10 times exhibited highly statistically significant differences and powerful positive effect sizes in their high-stakes exam grades (p=0.0001, d=0.74) and critical reflection skills (p=0.005, d=1.41) when compared to those who did not assess one another. Furthermore, only the same 22 students showed a statistically significant increase and positive effect size in their critical reflection skills from baseline to resultant (p=0.003, d=1.04). The results of this study suggest that the protocol used has the potential to impact dental students' academic and reflection skills, provided it is practiced in ten or more peer encounters and ensuring peer feedback is provided followed by self-reflection.

  2. Benefits and harms in clinical trials of duloxetine for treatment of major depressive disorder: comparison of clinical study reports, trial registries, and publications

    PubMed Central

    Tendal, Britta; Hróbjartsson, Asbjørn; Jørgensen, Karsten Juhl; Lundh, Andreas; Schroll, Jeppe; Gøtzsche, Peter C

    2014-01-01

    Objective To determine, using research on duloxetine for major depressive disorder as an example, if there are inconsistencies between protocols, clinical study reports, and main publicly available sources (journal articles and trial registries), and within clinical study reports themselves, with respect to benefits and major harms. Design Data on primary efficacy analysis and major harms extracted from each data source and compared. Setting Nine randomised placebo controlled trials of duloxetine (total 2878 patients) submitted to the European Medicines Agency (EMA) for marketing approval for major depressive disorder. Data sources Clinical study reports, including protocols as appendices (total 13 729 pages), were obtained from the EMA in May 2011. Journal articles were identified through relevant literature databases and contacting the manufacturer, Eli Lilly. Clinicaltrials.gov and the manufacturer’s online clinical trial registry were searched for trial results. Results Clinical study reports fully described the primary efficacy analysis and major harms (deaths (including suicides), suicide attempts, serious adverse events, and discontinuations because of adverse events). There were minor inconsistencies in the population in the primary efficacy analysis between the protocol and clinical study report and within the clinical study report for one trial. Furthermore, we found contradictory information within the reports for seven serious adverse events and eight adverse events that led to discontinuation but with no apparent bias. In each trial, a median of 406 (range 177-645) and 166 (100-241) treatment emergent adverse events (adverse events that emerged or worsened after study drug was started) in the randomised phase were not reported in journal articles and Lilly trial registry reports, respectively. We also found publication bias in relation to beneficial effects. Conclusion Clinical study reports contained extensive data on major harms that were

  3. Clinical and microbiological benefits of strict supragingival plaque control as part of the active phase of periodontal therapy

    PubMed Central

    FERES, Magda; GURSKY, Lauren Christine; FAVERI, Marcelo; TSUZUKI, Claudia Ota; FIGUEIREDO, Luciene Cristina

    2009-01-01

    Aim To compare the clinical and microbiological effects of scaling and root planing (SRP) alone or combined with mechanical (professional plaque control - PPC) or chemical (chlorhexidine rinsing - CHX) control of supragingival plaque in the treatment of chronic periodontitis. Methods Sixty subjects were randomly assigned to receive SRP alone or combined with PPC (twice a week) or with CHX rinsing (twice a day). The adjunctive treatments began with SRP and continued for 42 days. Clinical and microbiological examinations were performed at baseline, 2 and 6 months post-therapy. Subgingival plaque samples were analyzed for 38 bacterial species by checkerboard DNA-DNA hybridization. Results The two test treatments were more effective in improving probing depth and clinical attachment level (CAL) than SRP alone, even in intermediate and deep sites. CAL gain was better maintained in the CHX group. The most beneficial microbiological changes were observed in CHX-treated subjects, who showed a significant reduction in the proportions of red and orange complexes, as well as an increase in the proportions of the host-compatible bacterial species. Conclusion Strict plaque control performed during and after SRP improves periodontal treatment outcomes. The greatest microbiological and clinical benefits were observed with the use of CHX rinsing. PMID:19703236

  4. Net benefits: assessing the effectiveness of clinical networks in Australia through qualitative methods

    PubMed Central

    2012-01-01

    Background In the 21st century, government and industry are supplementing hierarchical, bureaucratic forms of organization with network forms, compatible with principles of devolved governance and decentralization of services. Clinical networks are employed as a key health policy approach to engage clinicians in improving patient care in Australia. With significant investment in such networks in Australia and internationally, it is important to assess their effectiveness and sustainability as implementation mechanisms. Methods In two purposively selected, musculoskeletal clinical networks, members and stakeholders were interviewed to ascertain their perceptions regarding key factors relating to network effectiveness and sustainability. We adopted a three-level approach to evaluating network effectiveness: at the community, network, and member levels, across the network lifecycle. Results Both networks studied are advisory networks displaying characteristics of the ‘enclave’ type of non-hierarchical network. They are hybrids of the mandated and natural network forms. In the short term, at member level, both networks were striving to create connectivity and collaboration of members. Over the short to medium term, at network level, both networks applied multi-disciplinary engagement in successfully developing models of care as key outputs, and disseminating information to stakeholders. In the long term, at both community and network levels, stakeholders would measure effectiveness by the broader statewide influence of the network in changing and improving practice. At community level, in the long term, stakeholders acknowledged both networks had raised the profile, and provided a ‘voice’ for musculoskeletal conditions, evidencing some progress with implementation of the network mission while pursuing additional implementation strategies. Conclusions This research sheds light on stakeholders’ perceptions of assessing clinical network effectiveness at

  5. Imaging Radiation Doses and Associated Risks and Benefits in Subjects Participating in Breast Cancer Clinical Trials

    PubMed Central

    Spera, Gonzalo; Meyer, Carlos; Cabral, Pablo; Mackey, John R.

    2015-01-01

    Background. Medical imaging is commonly required in breast cancer (BC) clinical trials to assess the efficacy and/or safety of study interventions. Despite the lack of definitive epidemiological data linking imaging radiation with cancer development in adults, concerns exist about the risks of imaging radiation-induced malignancies (IRIMs) in subjects exposed to repetitive imaging. We estimated the imaging radiation dose and IRIM risk in subjects participating in BC trials. Materials and Methods. The imaging protocol requirements in 10 phase III trials in the adjuvant and advanced settings were assessed to estimate the effective radiation dose received by a typical and fully compliant subject in each trial. For each study, the excess lifetime attributable cancer risk (LAR) was calculated using the National Cancer Institute’s Radiation Risk Assessment Tool, version 3.7.1. Dose and risk calculations were performed for both imaging intensive and nonintensive approaches to reflect the variability in imaging performed within the studies. Results. The total effective imaging radiation dose was 0.4–262.2 mSv in adjuvant trials and 26–241.3 mSv in metastatic studies. The dose variability resulted from differing protocol requirements and imaging intensity approaches, with computed tomography, multigated acquisition scans, and bone scans as the major contributors. The mean LAR was 1.87–2,410/100,000 in adjuvant trials (IRIM: 0.0002%–2.41% of randomized subjects) and 6.9–67.3/100,000 in metastatic studies (IRIM: 0.007%–0.067% of subjects). Conclusion. IRIMs are infrequent events. In adjuvant trials, aligning the protocol requirements with the clinical guidelines’ surveillance recommendations and substituting radiating procedures with equivalent nonradiating ones would reduce IRIM risk. No significant risk has been observed in metastatic trials, and potential concerns on IRIMs are not justified. Implications for Practice: Medical imaging is key in breast cancer

  6. Is there evidence-based hypolipidemic treatment with clinical benefit beyond statins?

    PubMed

    Goumas, Georgios S

    2009-01-01

    Aggressive therapy with statins to lower the low density lipoprotein cholesterol decreases cardiovascular events. Nevertheless, administration of the highest approved statin dose only offers limited additional benefit at the expense of an increased incidence of side effects. Therefore, novel compounds that further reduce the low-density lipoprotein cholesterol and at the same time have beneficial effects on other lipid parameters when added to statin therapy are under investigation. Nicotinic acid lowers the levels of the low-density lipoprotein cholesterol and triglycerides while raising the concentration of the protective high-density lipoprotein cholesterol. A significant inverse association exists between long-term intake of omega-3 fatty acids and cardiovascular mortality; these fish oils lower serum triglycerides levels. Fibrates substantially decrease triglycerides, increase high density lipoprotein cholesterol, and modestly decrease low-density lipoprotein cholesterol levels. Ezetimibe selectively inhibits cholesterol absorption in the gut. Combined therapy with ezetimibe and a statin provides an incremental reduction in the low-density lipoprotein cholesterol levels. PMID:19019838

  7. [Clinical benefit of HCV core antigen assay in patients receiving interferon and ribavirin combination therapy].

    PubMed

    Higashimoto, Makiko; Takahashi, Masahiko; Jokyu, Ritsuko; Saito, Hidetsugu

    2006-02-01

    A highly sensitive second generation HCV core antigen assay has recently been developed. We compared viral disappearance and kinetics data between commercially available core antigen assays, Lumipulse Ortho HCV Ag, and a quantitative HCV RNA PCR assay, Cobas Amplicor HCV Monitor Test, Version 2 to estimate the predictive benefit of sustained viral response (SVR) and non-SVR in 59 patients treated with interferon and ribavirin combination therapy. We found a good correlation between HCV core Ag and HCV RNA level regardless of genotype. Although the sensitivity of the core antigen assay was lower than PCR, the dynamic range was broader than that of the PCR assay, so that we did not need to dilute the samples in 59 patients. We detected serial decline of core Ag levels in 24 hrs, 7 days and 14 days after interferon combination therapy. The decline of core antigen levels was significant in SVR patients compared to non-SVR as well as in genotype 2a, 2b patients compared to 1b. Core antigen-negative on day 1 could predict all 10 SVR patients (PPV = 100%), whereas RNA-negative could predict 22 SVR out of 25 on day 14 (PPV = 88.0%). None of the patients who had detectable serum core antigen on day 14 became SVR(NPV = 100%), although NPV was 91.2% on RNA negativity. An easy, simple, low cost new HCV core antigen detecting system seems to be useful for assessing and monitoring IFN treatment for HCV.

  8. Clinically Normal Stereopsis Does Not Ensure a Performance Benefit from Stereoscopic 3D Depth Cues

    NASA Astrophysics Data System (ADS)

    McIntire, John P.; Havig, Paul R.; Harrington, Lawrence K.; Wright, Steve T.; Watamaniuk, Scott N. J.; Heft, Eric L.

    2014-09-01

    To investigate the effect of manipulating disparity on task performance and viewing comfort, twelve participants were tested on a virtual object precision placement task while viewing a stereoscopic 3D (S3D) display. All participants had normal or corrected-to-normal visual acuity, passed the Titmus stereovision clinical test, and demonstrated normal binocular function, including phorias and binocular fusion ranges. Each participant completed six experimental sessions with different maximum binocular disparity limits. The results for ten of the twelve participants were generally as expected, demonstrating a large performance advantage when S3D cues were provided. The sessions with the larger disparity limits typically resulted in the best performance, and the sessions with no S3D cues the poorest performance. However, one participant demonstrated poorer performance in sessions with smaller disparity limits but improved performance in sessions with the larger disparity limits. Another participant's performance declined whenever any S3D cues were provided. Follow-up testing suggested that the phenomenon of pseudo-stereoanomaly may account for one viewer's atypical performance, while the phenomenon of stereoanomaly might account for the other. Overall, the results demonstrate that a subset of viewers with clinically normal binocular and stereoscopic vision may have difficulty performing depth-related tasks on S3D displays. The possibility of the vergence-accommodation conflict contributing to individual performance differences is also discussed.

  9. Use of clinically available PPAR agonists for heart failure; do the risks outweigh the potential benefits?

    PubMed

    Sarma, Satyam

    2012-06-01

    PPAR agonists represent a heterogeneous group of compounds that have been used in the treatment of cardiovascular and metabolic diseases for over thirty years. While the primary indications for PPAR agonist therapy focus on hyperlipidemia and diabetes, there is a growing body of pre-clinical data that suggests they may be beneficial in the treatment of heart failure; a disease marked by abnormal myocardial metabolism, fibrosis and insulin insensitivity. PPAR agonist treatment in numerous animal models of systolic heart failure have demonstrated improvement in cardiac function with decreased fibrosis, improved contractility and endothelial function. However, considerable controversy exists on the cardiac safety profile of PPAR agonists, particularly concern for inducing lipotoxicty and precipitating or worsening heart failure. In addition during pre-clinical testing, many compounds have been associated with increased death and adverse cardiovascular outcomes casting a pall over their future use for treating disorders of myocardial function. This article will review cardiac pathways involved in PPAR activation and their potential regulation of maladaptive pathways involved in heart failure and highlight molecular mechanisms that may contribute to adverse events and raise safety concerns. Specific attention will be focused on PPAR alpha and gamma, subtypes for which commercially available PPAR agonists are currently available.

  10. The Clinical Benefits of Adding a Third Dimension to Assess the Left Ventricle with Echocardiography

    PubMed Central

    Badano, Luigi P.

    2014-01-01

    Three-dimensional echocardiography is a novel imaging technique based on acquisition and display of volumetric data sets in the beating heart. This permits a comprehensive evaluation of left ventricular (LV) anatomy and function from a single acquisition and expands the diagnostic possibilities of noninvasive cardiology. It provides the possibility of quantitating geometry and function of LV without preestablished assumptions regarding cardiac chamber shape and allows an echocardiographic assessment of the LV that is less operator-dependent and therefore more reproducible. Further developments and improvements for widespread routine applications include higher spatial and temporal resolution to improve image quality, faster acquisition, processing and reconstruction, and fully automated quantitative analysis. At present, three-dimensional echocardiography complements routine 2DE in clinical practice, overcoming some of its limitations and offering additional valuable information that has led to recommending its use for routine assessment of the LV of patients in whom information about LV size and function is critical for their clinical management. PMID:24959374

  11. [Institute for clinical management of nephro-urological diseases: the benefits of a quality care programme].

    PubMed

    Santiñá, M; Arrizabalaga, P; Prat, A; Alcaraz, A; Campistol, J M; Trilla, A

    2009-01-01

    The Clinic Institute of Nefro and Urology (ICNU) was formed in Clinic Hospital of Barcelona in 1999. It grouped together services of Nephrology, Urology and Renal Transplant. At the same time, in order to ensure Quality in this process of change, we designed a specific quality program. In this program, we defined objectives to improve the quality of these services in one year and we defined different quality indicators in order to maintain and monitor health quality. The indicators referred to technical quality and perceived quality and we periodically evaluated their evolution. The results of the last five years indicate that the majority of the indicators have improved, except those concerning infections surgery and the response to complaints. This has helped the consolidation and recognition of the work of this innovatory project in the health management of the nephrologic and urinary systems that locate the patient in the center of the organization and recognize the health professionals as the true managers of this model.

  12. Clinical benefits of bortezomib-containing regimens for newly diagnosed AL amyloidosis with severe cardiac impairment.

    PubMed

    Tsukune, Yutaka; Yahata, Yuriko; Sasaki, Makoto; Hiki, Makoto; Tsutsui, Miyuki; Hamano, Yasuharu; Itoh, Seigo; Miyazaki, Tetsuro; Dohi, Tomotaka; Maruyama, Masaki; Gotoh, Akihiko; Komatsu, Norio

    2016-08-01

    Cardiac amyloid light-chain amyloidosis (AL amyloidosis) is a rare disease with a very poor prognosis, associated with plasma cell dyscrasias such as monoclonal gammopathy of undetermined significance and multiple myeloma. Though bortezomib-containing regimens have achieved high hematologic response rates, there are still few reports describing the outcomes of Japanese patients. Six patients with severe cardiac AL amyloidosis were treated with bortezomib-containing regimens. Involved free light chain (iFLC) decreased immediately in most of these cases. However, the condition of heart failure and N-terminal pro-B-type natriuretic peptide (NT-proBNP) worsened in the early phase of this treatment and then improved several months later. At 29 months, the median duration of follow-up (2-47months), all patients remain alive except one who died of sudden cardiac arrest. Bortezomib-containing regimens are considered to be among the effective treatments for severe cardiac AL amyloidosis. PMID:27599413

  13. Clinical benefits of bortezomib-containing regimens for newly diagnosed AL amyloidosis with severe cardiac impairment.

    PubMed

    Tsukune, Yutaka; Yahata, Yuriko; Sasaki, Makoto; Hiki, Makoto; Tsutsui, Miyuki; Hamano, Yasuharu; Itoh, Seigo; Miyazaki, Tetsuro; Dohi, Tomotaka; Maruyama, Masaki; Gotoh, Akihiko; Komatsu, Norio

    2016-08-01

    Cardiac amyloid light-chain amyloidosis (AL amyloidosis) is a rare disease with a very poor prognosis, associated with plasma cell dyscrasias such as monoclonal gammopathy of undetermined significance and multiple myeloma. Though bortezomib-containing regimens have achieved high hematologic response rates, there are still few reports describing the outcomes of Japanese patients. Six patients with severe cardiac AL amyloidosis were treated with bortezomib-containing regimens. Involved free light chain (iFLC) decreased immediately in most of these cases. However, the condition of heart failure and N-terminal pro-B-type natriuretic peptide (NT-proBNP) worsened in the early phase of this treatment and then improved several months later. At 29 months, the median duration of follow-up (2-47months), all patients remain alive except one who died of sudden cardiac arrest. Bortezomib-containing regimens are considered to be among the effective treatments for severe cardiac AL amyloidosis.

  14. The clinical benefits, ethics, and economics of stratified medicine and companion diagnostics.

    PubMed

    Trusheim, Mark R; Berndt, Ernst R

    2015-12-01

    The stratified medicine companion diagnostic (CDx) cut-off decision integrates scientific, clinical, ethical, and commercial considerations, and determines its value to developers, providers, payers, and patients. Competition already sharpens these issues in oncology, and might soon do the same for emerging stratified medicines in autoimmune, cardiovascular, neurodegenerative, respiratory, and other conditions. Of 53 oncology targets with a launched therapeutic, 44 have competing therapeutics. Only 12 of 141 Phase III candidates addressing new targets face no competition. CDx choices might alter competitive positions and reimbursement. Under current diagnostic incentives, payers see novel stratified medicines that improve public health and increase costs, but do not observe companion diagnostics for legacy treatments that would reduce costs. It would be in the interests of payers to rediscover their heritage of direct investment in diagnostic development. PMID:26542060

  15. Clinical benefits of alpharadin in castrate-chemotherapy-resistant prostate cancer: case report and literature review

    PubMed Central

    Croke, Jennifer; Leung, Eugene; Segal, Roanne; Malone, Shawn

    2012-01-01

    Prostate cancer has the second-highest mortality worldwide in men. The most common site of metastasis is bone. Bone metastases and their resulting complications represent a significant source of morbidity. Radioisotopes have been used for treatment of painful bony metastases. Although shown to decrease pain and analgesia use, this has not improved outcomes. The following case report describes a patient with castrate-resistant prostate cancer who was treated with the radioisotope radium-223 as part of the phase III clinical trial Alpharadin in Patients with Symptomatic Hormone Refractory Prostate Cancer with Skeletal Metastases (ALSYMPCA). He responded to radium-223 with pain relief, bone scan response, stabilisation of prostate specific antigen (PSA) and normalisation of alkaline phosphatase. Interim analysis of this trial has shown that radium-223 significantly prolongs overall survival, time to first skeletal-related event and is well tolerated. Alpharadin is a new treatment option for men with castrate-resistant prostate cancer and symptomatic bone metastases. PMID:23125297

  16. Necessity and benefits of physician assistants' participation in international clinical experiences.

    PubMed

    Kibe, Lucy Wachera

    2012-01-01

    Several consultation stations have been set up in an unfinished stone building. My team is made up of a Kenyan physician assistant (called clinical officer), a Kenyan medical student, and me, a US physician assistant student. We are huddled around a small worn-out square table. A middle-aged woman and her two children, ages 2 and 6, approach the table. They have traveled 2 miles to the medical camp. The children, covered in dust, are emaciated with protruding abdomens, dry skin, and congested noses. The clinical officer (CO) conducts a brief interview in Swahili, the Kenyan national language. The mother explains that they have been coughing up thick yellow sputum for a week and have no appetite. They've also had diarrhea for a couple of weeks. I examine the children, who are obviously scared. Hot, moist skin. They are both running a fever. I listen to the lungs: reduced lung sounds. The protruding abdomens are rock hard. I report the findings to the team. The CO turns to the Kenyan medical student and me and quizzes us on differential diagnoses with rationale for each. We come up with malaria, pneumonia, TB, and worm infestation. Due to limited resources, medical diagnosis in Kenya relies heavily on history and physical exam. The CO explains that comorbid conditions are probable. Luckily, we have malaria-testing kits at the camp. They test negative for malaria. We decide to treat them for pneumonia. We also offer them a free hot meal, toothbrushes, T-shirts, coloring paper, and crayons. The children manage to smile. The mother is so grateful, she cries. PMID:23437625

  17. Clinical and economic benefits of fidaxomicin compared to vancomycin for Clostridium difficile infection.

    PubMed

    Gallagher, Jason C; Reilly, Joseph P; Navalkele, Bhagyashri; Downham, Gemma; Haynes, Kevin; Trivedi, Manish

    2015-11-01

    We studied the clinical and economic impact of a protocol encouraging the use of fidaxomicin as a first-line drug for treatment of Clostridium difficile infection (CDI) in patients hospitalized during a 2-year period. This study evaluated patients who received oral vancomycin or fidaxomicin for the treatment of CDI during a 2-year period. All included patients were eligible for administration of fidaxomicin via a protocol that encouraged its use for selected patients. The primary clinical endpoint was 90-day readmission with a diagnosis of CDI. Hospital charges and insurance reimbursements for readmissions were calculated along with the cost of CDI therapy to estimate the financial impact of the choice of therapy. Recurrences were seen in 10/49 (20.4%) fidaxomicin patients and 19/46 (41.3%) vancomycin patients (P = 0.027). In a multivariate analysis that included determinations of severity of CDI, serum creatinine increases, and concomitant antibiotic use, only fidaxomicin was significantly associated with decreased recurrence (adjusted odds ratio [aOR], 0.33; 95% confidence interval [CI], 0.12 to 0.93). The total lengths of stay of readmitted patients were 183 days for vancomycin and 87 days for fidaxomicin, with costs of $454,800 and $196,200, respectively. Readmissions for CDI were reimbursed on the basis of the severity of CDI, totaling $151,136 for vancomycin and $107,176 for fidaxomicin. Fidaxomicin drug costs totaled $62,112, and vancomycin drug costs were $6,646. We calculated that the hospital lost an average of $3,286 per fidaxomicin-treated patient and $6,333 per vancomycin-treated patient, thus saving $3,047 per patient with fidaxomicin. Fidaxomicin use for CDI treatment prevented readmission and decreased hospital costs compared to use of oral vancomycin.

  18. HIV-specific humoral responses benefit from stronger prime in phase Ib clinical trial

    PubMed Central

    Bart, Pierre-Alexandre; Huang, Yunda; Karuna, Shelly T.; Chappuis, Samuel; Gaillard, Julien; Kochar, Nidhi; Shen, Xiaoying; Allen, Mary A.; Ding, Song; Hural, John; Liao, Hua-Xin; Haynes, Barton F.; Graham, Barney S.; Gilbert, Peter B.; McElrath, M. Juliana; Montefiori, David C.; Tomaras, Georgia D.; Pantaleo, Giuseppe; Frahm, Nicole

    2014-01-01

    BACKGROUND. Vector prime-boost immunization strategies induce strong cellular and humoral immune responses. We examined the priming dose and administration order of heterologous vectors in HIV Vaccine Trials Network 078 (HVTN 078), a randomized, double-blind phase Ib clinical trial to evaluate the safety and immunogenicity of heterologous prime-boost regimens, with a New York vaccinia HIV clade B (NYVAC-B) vaccine and a recombinant adenovirus 5–vectored (rAd5-vectored) vaccine. METHODS. NYVAC-B included HIV-1 clade B Gag-Pol-Nef and gp120, while rAd5 included HIV-1 clade B Gag-Pol and clades A, B, and C gp140. Eighty Ad5-seronegative subjects were randomized to receive 2 × NYVAC-B followed by 1 × 1010 PFU rAd5 (NYVAC/Ad5hi); 1 × 108 PFU rAd5 followed by 2 × NYVAC-B (Ad5lo/NYVAC); 1 × 109 PFU rAd5 followed by 2 × NYVAC-B (Ad5med/NYVAC); 1 × 1010 PFU rAd5 followed by 2 × NYVAC-B (Ad5hi/NYVAC); or placebo. Immune responses were assessed 2 weeks after the final vaccination. Intracellular cytokine staining measured T cells producing IFN-γ and/or IL-2; cross-clade and epitope-specific binding antibodies were determined; and neutralizing antibodies (nAbs) were assessed with 6 tier 1 viruses. RESULTS. CD4+ T cell response rates ranged from 42.9% to 93.3%. NYVAC/Ad5hi response rates (P ≤ 0.01) and magnitudes (P ≤ 0.03) were significantly lower than those of other groups. CD8+ T cell response rates ranged from 65.5% to 85.7%. NYVAC/Ad5hi magnitudes were significantly lower than those of other groups (P ≤ 0.04). IgG response rates to the group M consensus gp140 were 89.7% for NYVAC/Ad5hi and 21.4%, 84.6%, and 100% for Ad5lo/NYVAC, Ad5med/NYVAC, and Ad5hi/NYVAC, respectively, and were similar for other vaccine proteins. Overall nAb responses were low, but aggregate responses appeared stronger for Ad5med/NYVAC and Ad5hi/NYVAC than for NYVAC/Ad5hi. CONCLUSIONS. rAd5 prime followed by NYVAC boost is superior to the reverse regimen for both vaccine

  19. Benefits attained from space flight in pre-clinical evaluation of candidate drugs

    NASA Astrophysics Data System (ADS)

    Stodieck, Louis S.; Bateman, Ted; Ayers, Reed; Ferguson, Virginia; Simske, Steve

    1998-01-01

    Modern medicine has made great strides in recent decades. The promises of biotechnology and advances in gene identification and manipulation offer tremendous potential for treatment of disease. However, developing new drug therapies by biotechnology and pharmaceutical companies is still a very costly and time consuming process. One of the important milestones in drug development is the successful completion of preclinical evaluation. During this phase, drug candidates must be shown to be safe, yet effective as a treatment of the target disease or disorder. Critical for preclinical testing is the availability of biomedical test models that adequately mimic the target disease. A good model will 1) allow confident prediction of a drug's effects before expensive clinical trials are begun, 2) provide convincing data for use in an FDA new drug application and 3) minimize the time required for testing. Space flight may offer a completely unique and new set of biomedical models for use in pharmaceutical testing. This paper highlights some examples of recent experiments done in space to test new compounds for Chiron, (Emmeryville, CA) and discusses the importance of the International Space Station to greatly expand such commercial opportunities.

  20. Hypnosis in the Perioperative Management of Breast Cancer Surgery: Clinical Benefits and Potential Implications

    PubMed Central

    Roelants, Fabienne; Pospiech, Audrey; Momeni, Mona; Watremez, Christine

    2016-01-01

    The aim of this review is to summarize data published on the use of perioperative hypnosis in patients undergoing breast cancer surgery (BCS). Indeed, the majority of BCS patients experience stress, anxiety, nausea, vomiting, and pain. Correct management of the perioperative period and surgical removal of the primary tumor are clearly essential but can affect patients on different levels and hence have a negative impact on oncological outcomes. This review examines the effect of clinical hypnosis performed during the perioperative period. Thanks to its specific properties and techniques allowing it to be used as complementary treatment preoperatively, hypnosis has an impact most notably on distress and postoperative pain. During surgery, hypnosis may be applied to limit immunosuppression, while, in the postoperative period, it can reduce pain, anxiety, and fatigue and improve wound healing. Moreover, hypnosis is inexpensive, an important consideration given current financial concerns in healthcare. Of course, large randomized prospective studies are now needed to confirm the observed advantages of hypnosis in the field of oncology.

  1. Hypnosis in the Perioperative Management of Breast Cancer Surgery: Clinical Benefits and Potential Implications

    PubMed Central

    Roelants, Fabienne; Pospiech, Audrey; Momeni, Mona; Watremez, Christine

    2016-01-01

    The aim of this review is to summarize data published on the use of perioperative hypnosis in patients undergoing breast cancer surgery (BCS). Indeed, the majority of BCS patients experience stress, anxiety, nausea, vomiting, and pain. Correct management of the perioperative period and surgical removal of the primary tumor are clearly essential but can affect patients on different levels and hence have a negative impact on oncological outcomes. This review examines the effect of clinical hypnosis performed during the perioperative period. Thanks to its specific properties and techniques allowing it to be used as complementary treatment preoperatively, hypnosis has an impact most notably on distress and postoperative pain. During surgery, hypnosis may be applied to limit immunosuppression, while, in the postoperative period, it can reduce pain, anxiety, and fatigue and improve wound healing. Moreover, hypnosis is inexpensive, an important consideration given current financial concerns in healthcare. Of course, large randomized prospective studies are now needed to confirm the observed advantages of hypnosis in the field of oncology. PMID:27635132

  2. Hypnosis in the Perioperative Management of Breast Cancer Surgery: Clinical Benefits and Potential Implications.

    PubMed

    Potié, Arnaud; Roelants, Fabienne; Pospiech, Audrey; Momeni, Mona; Watremez, Christine

    2016-01-01

    The aim of this review is to summarize data published on the use of perioperative hypnosis in patients undergoing breast cancer surgery (BCS). Indeed, the majority of BCS patients experience stress, anxiety, nausea, vomiting, and pain. Correct management of the perioperative period and surgical removal of the primary tumor are clearly essential but can affect patients on different levels and hence have a negative impact on oncological outcomes. This review examines the effect of clinical hypnosis performed during the perioperative period. Thanks to its specific properties and techniques allowing it to be used as complementary treatment preoperatively, hypnosis has an impact most notably on distress and postoperative pain. During surgery, hypnosis may be applied to limit immunosuppression, while, in the postoperative period, it can reduce pain, anxiety, and fatigue and improve wound healing. Moreover, hypnosis is inexpensive, an important consideration given current financial concerns in healthcare. Of course, large randomized prospective studies are now needed to confirm the observed advantages of hypnosis in the field of oncology. PMID:27635132

  3. From cannabis to the endocannabinoid system: refocussing attention on potential clinical benefits.

    PubMed

    Youssef, F F; Irving, A J

    2012-06-01

    Cannabis sativa is one of the oldest herbal remedies known to man. Over the past four thousand years, it has been used for the treatment of numerous diseases but due to its psychoactive properties, its current medicinal usage is highly restricted. In this review, we seek to highlight advances made over the last forty years in the understanding of the mechanisms responsible for the effects of cannabis on the human body and how these can potentially be utilized in clinical practice. During this time, the primary active ingredients in cannabis have been isolated, specific cannabinoid receptors have been discovered and at least five endogenous cannabinoid neurotransmitters (endocannabinoids) have been identified. Together, these form the framework of a complex endocannabinoid signalling system that has widespread distribution in the body and plays a role in regulating numerous physiological processes within the body. Cannabinoid ligands are therefore thought to display considerable therapeutic potential and the drive to develop compounds that can be targeted to specific neuronal systems at low enough doses so as to eliminate cognitive side effects remains the 'holy grail' of endocannabinoid research.

  4. Effectiveness of an on-site health clinic at a self-insured university: a cost-benefit analysis.

    PubMed

    McCaskill, Sherrie P; Schwartz, Lisa A; Derouin, Anne L; Pegram, Angela H

    2014-04-01

    This study assessed the impact and cost-effectiveness of an on-site health clinic at a self-insured university. Health care costs and number of claims filed to primary care providers were trended before and after the clinic was established to determine savings. A retrospective chart review of all full-time, insured employees treated for upper respiratory tract infections (URIs) during a 1-year study period was conducted. On-site clinic costs for the treatment of URIs were compared to costs at outside community providers for similar care. Community cost norms for the treatment of URIs were provided by Primary Physicians Care, the administrator of insurance claims for the University. A cost-benefit analysis compared the cost of services on-site versus similar services at an outside community provider. Based on the results of this study, the University's on-site health care services were determined to be more cost-effective than similar off-site health care services for the treatment of URIs. [Workplace Health Saf 2014;62(4):162-169.].

  5. Exemplary Care and Learning Sites: A Model for Achieving Continual Improvement in Care and Learning in the Clinical Setting

    PubMed Central

    Ogrinc, Greg; Hoffman, Kimberly G.; Stevenson, Katherine M.; Shalaby, Marc; Beard, Albertine S.; Thörne, Karin E.; Coleman, Mary T.; Baum, Karyn D.

    2016-01-01

    Problem Current models of health care quality improvement do not explicitly describe the role of health professions education. The authors propose the Exemplary Care and Learning Site (ECLS) model as an approach to achieving continual improvement in care and learning in the clinical setting. Approach From 2008–2012, an iterative, interactive process was used to develop the ECLS model and its core elements—patients and families informing process changes; trainees engaging both in care and the improvement of care; leaders knowing, valuing, and practicing improvement; data transforming into useful information; and health professionals competently engaging both in care improvement and teaching about care improvement. In 2012–2013, a three-part feasibility test of the model, including a site self-assessment, an independent review of each site’s ratings, and implementation case stories, was conducted at six clinical teaching sites (in the United States and Sweden). Outcomes Site leaders reported the ECLS model provided a systematic approach toward improving patient (and population) outcomes, system performance, and professional development. Most sites found it challenging to incorporate the patients and families element. The trainee element was strong at four sites. The leadership and data elements were self-assessed as the most fully developed. The health professionals element exhibited the greatest variability across sites. Next Steps The next test of the model should be prospective, linked to clinical and educa tional outcomes, to evaluate whether it helps care delivery teams, educators, and patients and families take action to achieve better patient (and population) outcomes, system performance, and professional development. PMID:26760058

  6. Baseline risk as predictor of treatment benefit: three clinical meta-re-analyses.

    PubMed

    Arends, L R; Hoes, A W; Lubsen, J; Grobbee, D E; Stijnen, T

    2000-12-30

    A relationship between baseline risk and treatment effect is increasingly investigated as a possible explanation of between-study heterogeneity in clinical trial meta-analysis. An approach that is still often applied in the medical literature is to plot the estimated treatment effects against the estimated measures of risk in the control groups (as a measure of baseline risk), and to compute the ordinary weighted least squares regression line. However, it has been pointed out by several authors that this approach can be seriously flawed. The main problem is that the observed treatment effect and baseline risk measures should be viewed as estimates rather than the true values. In recent years several methods have been proposed in the statistical literature to potentially deal with the measurement errors in the estimates. In this article we propose a vague priors Bayesian solution to the problem which can be carried out using the 'Bayesian inference using Gibbs sampling' (BUGS) implementation of Markov chain Monte Carlo numerical integration techniques. Different from other proposed methods, it uses the exact rather than an approximate likelihood, while it can handle many different treatment effect measures and baseline risk measures. The method differs from a recently proposed Bayesian method in that it explicitly models the distribution of the underlying baseline risks. We apply the method to three meta-analyses published in the medical literature and compare the results with the outcomes of the other recently proposed methods. In particular we compare our approach to McIntosh's method, for which we show how it can be carried out using standard statistical software. We conclude that our proposed method offers a very general and flexible solution to the problem, which can be carried out relatively easily with existing Bayesian analysis software. A confidence band for the underlying relationship between true effect measure and baseline risk and a confidence interval

  7. Clinical and benefit--cost outcomes of teaching a mindfulness-based procedure to adult offenders with intellectual disabilities.

    PubMed

    Singh, Nirbhay N; Lancioni, Giulio E; Winton, Alan S W; Singh, Ashvind N; Adkins, Angela D; Singh, Judy

    2008-09-01

    The effects of a mindfulness-based procedure, called Meditation on the Soles of the Feet, were evaluated as a cognitive-behavioral intervention for physical aggression in 6 offenders with mild intellectual disabilities. They were taught a simple meditation technique that required them to shift their attention and awareness from the precursors of aggression to the soles of their feet, a neutral point on their body. Results showed that physical and verbal aggression decreased substantially, no Stat medication or physical restraint was required, and there were no staff or peer injuries. Benefit-cost analysis of lost days of work and cost of medical and rehabilitation because of injury caused by these individuals in both the 12 months prior to and following mindfulness-based training showed a 95.7% reduction in costs. This study suggests that this procedure may be a clinically effective and cost-effective method of enabling adult offenders with intellectual disabilities to control their aggression.

  8. Use of Anthropometry for the Prediction of Regional Body Tissue Distribution in Adults: Benefits and Limitations in Clinical Practice

    PubMed Central

    Scafoglieri, Aldo; Clarys, Jan Pieter; Cattrysse, Erik; Bautmans, Ivan

    2014-01-01

    Regional body composition changes with aging. Some of the changes in composition are considered major risk factors for developing obesity related chronic diseases which in turn may lead to increased mortality in adults. The role of anthropometry is well recognized in the screening, diagnosis and follow-up of adults for risk classification, regardless of age. Regional body composition is influenced by a number of intrinsic and extrinsic factors. Therapeutic measures recommended to lower cardiovascular disease risk include lifestyle changes. The aim of this review is to systematically summarize studies that assessed the relationships between anthropometry and regional body composition. The potential benefits and limitations of anthropometry for use in clinical practice are presented and suggestions for future research given. PMID:25489489

  9. Experience With Afatinib in Patients With Non-Small Cell Lung Cancer Progressing After Clinical Benefit From Gefitinib and Erlotinib

    PubMed Central

    Fischer, Jürgen R.; Grohé, Christian; Gütz, Sylvia; Thomas, Michael; Kimmich, Martin; Schneider, Claus-Peter; Laack, Eckart; Märten, Angela

    2014-01-01

    Background. Afatinib, an irreversible ErbB family blocker, demonstrated superiority to chemotherapy as first-line treatment in patients with EGFR-mutated non-small cell lung cancer (NSCLC). Afatinib is also active in patients progressing on EGFR tyrosine kinase inhibitors (EGFR-TKIs). We report the results of a large cohort of NSCLC patients receiving afatinib within a compassionate-use program (CUP). Patients and Methods. Patients with advanced NSCLC progressing after one line or more of chemotherapy and one line or more of EGFR-TKI treatment with either an EGFR mutation or documented clinical benefit were enrolled. Data collection was not monitored or verified by central review. The intention of this CUP was to provide controlled preregistration access to afatinib for patients with life-threatening diseases and no other treatment option. Results. From May 2010 to October 2013, 573 patients (65% female; median age: 64 years [range: 28–89 years]) were enrolled, with strong participation of community oncologists. Comorbidities were allowed, including second malignancies in 11% of patients. EGFR mutation status was available in 391 patients (72%), and 83% tested mutation positive. Median time to treatment failure (TTF) of 541 patients treated with afatinib was 3.7 months (range: 0.0 to >29.0 months). Median TTF was 4.0 and 2.7 months in patients with adenocarcinomas and squamous cell carcinomas, respectively, and 4.6 months in patients with EGFR-mutated NSCLC. Adverse events were generally manageable. Conclusion. Afatinib was able to be given in a real-world setting to heavily pretreated patients with EGFR-mutated or EGFR-TKI-sensitive NSCLC. Acknowledging the constraints of data collection in a CUP, afatinib appears to be safe and to confer some clinical benefit in this population. PMID:25232040

  10. Genomic profiling of lung adenocarcinoma patients reveals therapeutic targets and confers clinical benefit when standard molecular testing is negative

    PubMed Central

    Lim, Sun Min; Kim, Eun Young; Kim, Hye Ryun; Ali, Siraj M.; Greenbowe, Joel R.; Shim, Hyo Sup; Chang, Hyun; Lim, Seungtaek; Paik, Soonmyung; Cho, Byoung Chul

    2016-01-01

    Background: Identification of clinically relevant oncogenic drivers in advanced cancer is critical in selecting appropriate targeted therapy. Using next-generation sequencing (NGS)-based clinical cancer gene assay, we performed comprehensive genomic profiling (CGP) of advanced cases of lung adenocarcinoma. Methods: Formalin-fixed paraffin-embedded tumors from 51 lung adenocarcinoma patients whose tumors previously tested negative for EGFR/KRAS/ALK by conventional methods were collected, and CGP was performed via hybridization capture of 4,557 exons from 287 cancer-related genes and 47 introns from 19 genes frequently rearranged in cancer. Results: Genomic profiles of all 51 cases were obtained, with a median coverage of 564x and a total of 190 individual genomic alterations (GAs). GAs per specimen was a mean of 3.7 (range 0-10).Cancer genomes are characterized by 50% (80/190) non-synonymous base substitutions, 15% (29/190) insertions or deletion, and 3% (5/190) splice site mutation. TP53 mutation was the most common GAs (15%, n=29/190), followed by CDKN2A homozygous loss (5%, n=10/190), KRAS mutation (4%, n=8/190), EGFR mutation (4%, n=8/190) and MDM2 amplification (2%, n=5/190). As per NCCN guidelines, targetable GAs were identified in 16 patients (31%) (BRAF mutation [n=1], EGFR mutation [n=8], ERBB2 mutation [n=4], MET amplification [n=1], KIF5B-RET rearrangement [n=2], CCDC6-RET rearrangement [n=1], CD74-ROS1 rearrangement [n=1], EZR-ROS1 rearrangement [n=5], and SLC34A2-ROS1 rearrangement [n=1]). Conclusion: Fifty eight percent of patients wild type by standard testing for EGFR/KRAS/ALK have GAs identifiable by CGP that suggest benefit from target therapy. CGP used when standard molecular testing for NSCLC is negative can reveal additional avenues of benefit from targeted therapy. PMID:26992220

  11. The clinical benefits of long-term supplementation with omega-3 fatty acids in cystic fibrosis patients - A pilot study.

    PubMed

    Hanssens, L; Thiébaut, I; Lefèvre, N; Malfroot, A; Knoop, C; Duchateau, J; Casimir, G

    2016-05-01

    Effectiveness of omega-3 supplementation in cystic fibrosis (CF) remains controversial. This study sought to evaluate clinical status, exercise tolerance, inflammatory parameters, and erythrocyte fatty acid profile after 1 year of oral omega-3 supplementation in CF patients. Fifteen ΔF508-homozygous patients undergoing chronic azithromycin were randomized to receive omega-3 fish oil supplementation at a dose of 60mg/Kg/day or placebo. In comparison with the previous year, in the supplemented group, the number of pulmonary exacerbations decreased at 12 months (1.7 vs. 3.0, p<0.01), as did the duration of antibiotic therapy (26.5 days vs. 60.0 days, p<0.025). Supplementation significantly increased the levels of eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA) as early as <3 months of administration, with concomitant decreases in arachidonic acid (AA) levels. This pilot study suggests that long-term omega-3 supplementation offers several clinical benefits as to the number of exacerbations and duration of antibiotic therapy in CF patients.

  12. The DATAS rationale and design: a controlled, randomized trial to assess the clinical benefit of dual chamber (DDED) defibrillator.

    PubMed

    Quesada, Aurelio; Almendral, Jesús; Arribas, Fernando; Ricci, Renato; Wolpert, Christian; Adragao, Pedro; Cobo, Eric; Navarro, Xavier

    2004-03-01

    Single chamber (SC) implantable cardioverter defibrillators (ICDs) have several limitations that might be relevant during follow-up, like atrial pacing requirements, inadequate therapies, sustained atrial tachyarrhythmias and difficulties to achieve an accurate diagnosis of the arrhythmia. Dual chamber (DC) ICDs offer an attractive and rational solution, although controversy remains if the costs and complexity of these devices offer a real clinical advantage. The Dual Chamber & Atrial Tachyarrhythmias Adverse Events Study (DATAS) was designed to analyze the ability of DC ICD, DDED, to reduce clinically significant adverse events compared with SC ICD in a non-selected population with conventional indications for ICD implantation. This is a prospective, multicentre, randomized, open labelled study, with three arms: two of them (simulated SC ICD and true DC ICD) cross-over, and the third (true SC ICD) parallels the other two. The composite primary end point comprises four Clinically Significant Adverse Events (CSAE): (1) all-cause mortality, (2) invasive intervention, hospitalization or prolongation of hospitalization due to cardiovascular cause, (3) inappropriate shocks, and (4) sustained symptomatic atrial tachyarrhythmias that (a) require urgent termination or (b) last more than 48h leading to therapeutic intervention. Secondary end points constitute each of the individual components of CSAE, cardiovascular status, quality of life and a detailed analysis of atrial and ventricular arrhythmias. To date (June 2003) there have been 343 patients enroled from 947 screened patients. The projected enrollment includes 360 patients and the conclusion of the study is expected at the beginning of 2005.

  13. The Benefits of Including Clinical Factors in Rectal Normal Tissue Complication Probability Modeling After Radiotherapy for Prostate Cancer

    SciTech Connect

    Defraene, Gilles; Van den Bergh, Laura; Al-Mamgani, Abrahim; Haustermans, Karin; Heemsbergen, Wilma; Van den Heuvel, Frank; Lebesque, Joos V.

    2012-03-01

    Purpose: To study the impact of clinical predisposing factors on rectal normal tissue complication probability modeling using the updated results of the Dutch prostate dose-escalation trial. Methods and Materials: Toxicity data of 512 patients (conformally treated to 68 Gy [n = 284] and 78 Gy [n = 228]) with complete follow-up at 3 years after radiotherapy were studied. Scored end points were rectal bleeding, high stool frequency, and fecal incontinence. Two traditional dose-based models (Lyman-Kutcher-Burman (LKB) and Relative Seriality (RS) and a logistic model were fitted using a maximum likelihood approach. Furthermore, these model fits were improved by including the most significant clinical factors. The area under the receiver operating characteristic curve (AUC) was used to compare the discriminating ability of all fits. Results: Including clinical factors significantly increased the predictive power of the models for all end points. In the optimal LKB, RS, and logistic models for rectal bleeding and fecal incontinence, the first significant (p = 0.011-0.013) clinical factor was 'previous abdominal surgery.' As second significant (p = 0.012-0.016) factor, 'cardiac history' was included in all three rectal bleeding fits, whereas including 'diabetes' was significant (p = 0.039-0.048) in fecal incontinence modeling but only in the LKB and logistic models. High stool frequency fits only benefitted significantly (p = 0.003-0.006) from the inclusion of the baseline toxicity score. For all models rectal bleeding fits had the highest AUC (0.77) where it was 0.63 and 0.68 for high stool frequency and fecal incontinence, respectively. LKB and logistic model fits resulted in similar values for the volume parameter. The steepness parameter was somewhat higher in the logistic model, also resulting in a slightly lower D{sub 50}. Anal wall DVHs were used for fecal incontinence, whereas anorectal wall dose best described the other two endpoints. Conclusions: Comparable

  14. Two flavonolignans from milk thistle (Silybum marianum) inhibit CYP2C9-mediated warfarin metabolism at clinically achievable concentrations.

    PubMed

    Brantley, Scott J; Oberlies, Nicholas H; Kroll, David J; Paine, Mary F

    2010-03-01

    Milk thistle (Silybum marianum) is a popular herbal product used for hepatoprotection and chemoprevention. Two commercially available formulations are the crude extract, silymarin, and the semipurified product, silibinin. Silymarin consists of at least seven flavonolignans, of which the most prevalent are the diastereoisomers silybin A and silybin B; silibinin consists only of silybin A and silybin B. Based on a recent clinical study showing an interaction between a silymarin product and the CYP2C9 substrate losartan, the CYP2C9 inhibition properties of silybin A and silybin B and corresponding regioisomers, isosilybin A and isosilybin B, were evaluated using human liver microsomes (HLMs), recombinant CYP2C9 (rCYP2C9) enzymes, and the clinically relevant probe, (S)-warfarin. Silybin B was the most potent inhibitor in HLMs, followed by silybin A, isosilybin B, and isosilybin A (IC(50) of 8.2, 18, 74, and >100 microM, respectively). Next, silybin A and silybin B were selected for further characterization. As with HLMs, silybin B was more potent than silybin A toward rCYP2C9 1 (6.7 versus 12 microM), rCYP2C9 2 (9.3 versus 19 microM), and rCYP2C9 3 (2.4 versus 9.3 microM). Using a matrix of five substrate (1-15 microM) and six inhibitor (1-80 microM) concentrations and HLMs, both diastereoisomers inhibited (S)-warfarin 7-hydroxylation in a manner described best by a mixed-type inhibition model (K(i) values of 4.8 and 10 microM for silybin B and silybin A, respectively). These observations, combined with the high systemic silibinin concentrations (>5-75 microM) achieved in a phase I study involving prostate cancer patients, prompt clinical evaluation of a potential warfarin-milk thistle interaction.

  15. Two Flavonolignans from Milk Thistle (Silybum marianum) Inhibit CYP2C9-Mediated Warfarin Metabolism at Clinically Achievable Concentrations

    PubMed Central

    Brantley, Scott J.; Oberlies, Nicholas H.; Kroll, David J.

    2010-01-01

    Milk thistle (Silybum marianum) is a popular herbal product used for hepatoprotection and chemoprevention. Two commercially available formulations are the crude extract, silymarin, and the semipurified product, silibinin. Silymarin consists of at least seven flavonolignans, of which the most prevalent are the diastereoisomers silybin A and silybin B; silibinin consists only of silybin A and silybin B. Based on a recent clinical study showing an interaction between a silymarin product and the CYP2C9 substrate losartan, the CYP2C9 inhibition properties of silybin A and silybin B and corresponding regioisomers, isosilybin A and isosilybin B, were evaluated using human liver microsomes (HLMs), recombinant CYP2C9 (rCYP2C9) enzymes, and the clinically relevant probe, (S)-warfarin. Silybin B was the most potent inhibitor in HLMs, followed by silybin A, isosilybin B, and isosilybin A (IC50 of 8.2, 18, 74, and >100 μM, respectively). Next, silybin A and silybin B were selected for further characterization. As with HLMs, silybin B was more potent than silybin A toward rCYP2C9*1 (6.7 versus 12 μM), rCYP2C9*2 (9.3 versus 19 μM), and rCYP2C9*3 (2.4 versus 9.3 μM). Using a matrix of five substrate (1–15 μM) and six inhibitor (1–80 μM) concentrations and HLMs, both diastereoisomers inhibited (S)-warfarin 7-hydroxylation in a manner described best by a mixed-type inhibition model (Ki values of 4.8 and 10 μM for silybin B and silybin A, respectively). These observations, combined with the high systemic silibinin concentrations (>5–75 μM) achieved in a phase I study involving prostate cancer patients, prompt clinical evaluation of a potential warfarin-milk thistle interaction. PMID:19934397

  16. The Clinical Impact of Continuing to Prescribe Antiretroviral Therapy in Patients with Advanced AIDS Who Manifest No Virologic or Immunologic Benefit

    PubMed Central

    Wohl, David A.; Kendall, Michelle A.; Feinberg, Judith; Alston-Smith, Beverly; Owens, Susan; Chafey, Suzette; Marco, Michael; Maxwell, Sharon; Benson, Constance; Keiser, Philip; van der Horst, Charles; Jacobson, Mark A.

    2013-01-01

    Introduction Despite the efficacy and tolerability of modern antiretroviral therapy (ART), many patients with advanced AIDS prescribed these regimens do not achieve viral suppression or immune reconstitution as a result of poor adherence, drug resistance, or both. The clinical outcomes of continued ART prescription for such patients have not been well characterized. Methods We examined the causes and predictors of all-cause mortality, AIDS-defining conditions, and serious non-AIDS-defining events among a cohort of participants in a clinical trial of pre-emptive therapy for CMV disease. We focused on participants who, despite ART had failed to achieve virologic suppression and substantive immune reconstitution. Results 233 ART-receiving participants entered with a median baseline CD4+ T cell count of 30/mm3 and plasma HIV RNA of 5 log10 copies/mL. During a median 96 weeks of follow-up, 24.0% died (a mortality rate of 10.7/100 patient-years); 27.5% reported a new AIDS-defining condition, and 22.3% a new serious non-AIDS event. Of the deaths, 42.8% were due to an AIDS-defining condition, 44.6% were due to a non-AIDS-defining condition, and 12.5% were of unknown etiology. Decreased risk of mortality was associated with baseline CD4+ T cell count ≥25/mm3 and lower baseline HIV RNA. Conclusions Among patients with advanced AIDS prescribed modern ART who achieve neither virologic suppression nor immune reconstitution, crude mortality percentages appear to be lower than reported in cohorts of patients studied a decade earlier. Also, in contrast to the era before modern ART became available, nearly half of the deaths in our modern-era study were caused by serious non-AIDS-defining events. Even among the most advanced AIDS patients who were not obtaining apparent immunologic and virologic benefit from ART, continued prescription of these medications appears to alter the natural history of AIDS—improving survival and shifting the causes of death from AIDS- to non

  17. Benefits of Career and Technical Student Organizations' on Female and Racial Minority Students' Psychosocial and Achievement Outcomes

    ERIC Educational Resources Information Center

    Aragon, Steven R.; Alfeld, Corinne; Hansen, David M.

    2013-01-01

    The purpose of this study was to determine to what extent do CTSOs affect student psychosocial and achievement outcomes (above and beyond stand-alone CTE programs) when controlling for gender and race. Using a cross-sectional descriptive research design, a total of 5,677 students from 10 states were surveyed regarding their high school…

  18. An alternative clinical approach to achieve greater anterior than posterior maxillary expansion in cleft lip and palate patients.

    PubMed

    Oliveira, Dauro Douglas; Bartolomeo, Flávia Uchôa Costa; Cardinal, Lucas; Figueiredo, Daniel Santos Fonseca; Palomo, Juan Martin; Andrade, Ildeu

    2014-11-01

    Cleft lip and palate patients commonly present maxillary constriction, particularly in the anterior region. The aim of this case report was to describe an alternative clinical approach that used a smaller Hyrax screw unconventionally positioned to achieve greater anterior than posterior expansion in patients with complete unilateral cleft lip and palate. The idea presented here is to take advantage of a reduced dimension screw to position it anteriorly. When only anterior expansion was needed (patient 1), the appliance was soldered to the first premolar bands and associated to a transpalatal arch cemented to the first molars. However, when overall expansion was required (patient 2), the screw was positioned anteriorly, but soldered to the first molar bands. Intercanine, premolar, and first molar widths were measured on dental casts with a digital caliper. Pre-expansion and postexpansion radiographs and tomographies were also evaluated. A significant anterior expansion and no intermolar width increase were registered in the first patient. Although patient 2 also presented a greater anterior than posterior expansion, a noteworthy expansion occurred at the molar region. The alternative approach to expand the maxilla in cleft patients reported here caused greater anterior than posterior expansion when the Mini-Hyrax was associated to a transpalatal arch, and its reduced dimension also minimized discomfort and facilitated hygiene.

  19. A structured exercise programme during haemodialysis for patients with chronic kidney disease: clinical benefit and long-term adherence

    PubMed Central

    Anding, Kirsten; Bär, Thomas; Trojniak-Hennig, Joanna; Kuchinke, Simone; Krause, Rolfdieter; Rost, Jan M; Halle, Martin

    2015-01-01

    Objective Long-term studies regarding the effect of a structured physical exercise programme (SPEP) during haemodialysis (HD) assessing compliance and clinical benefit are scarce. Study design A single-centre clinical trial, non-randomised, investigating 46 patients with HD (63.2±16.3 years, male/female 24/22, dialysis vintage 4.4 years) performing an SPEP over 5 years. The SPEP (twice/week for 60 min during haemodialysis) consisted of a combined resistance (8 muscle groups) and endurance (supine bicycle ergometry) training. Exercise intensity was continuously adjusted to improvements of performance testing. Changes in endurance and resistance capacity, physical functioning and quality of life (QoL) were analysed over 1 year in addition to long-term adherence and economics of the programme over 5 years. Average power per training session, maximal strength tests (maximal exercise repetitions/min), three performance-based tests for physical function, SF36 for QoL were assessed in the beginning and every 6 months thereafter. Results 78% of the patients completed the programme after 1 year and 43% after 5 years. Participants were divided—according to adherence to the programme—into three groups: (1) high adherence group (HA, >80% of 104 training sessions within 12 months), (2) moderate adherence (MA, 60–80%), and 3. Low adherence group (LA, <60%)) with HA and MA evaluated quantitatively. One-year follow-up data revealed significant (p<0.05) improvement for both groups in all measured parameters: exercise capacity (HA: 55%, MA: 45%), strength (HA: >120%, MA: 40–50%), QoL in three scores of SF36 subscales and physical function in the three tests taken between 11% and 31%. Moreover, a quantitative correlation analysis revealed a close association (r=0.8) between large improvement of endurance capacity and weak physical condition (HA). Conclusions The exercise programme described improves physical function significantly and can be integrated

  20. The effect of format on parents' understanding of the risks and benefits of clinical research: a comparison between text, tables, and graphics.

    PubMed

    Tait, Alan R; Voepel-Lewis, Terri; Zikmund-Fisher, Brian J; Fagerlin, Angela

    2010-07-01

    There is a paucity of information regarding the optimal method of presenting risk/benefit information to parents of pediatric research subjects. This study, therefore, was designed to examine the effect of different message formats on parents' understanding of research risks and benefits. An Internet-administered survey was completed by 4,685 parents who were randomized to receive risk/benefit information about a study of pediatric postoperative pain control presented in different message formats (text, tables, and pictographs). Survey questions assessed participants' gist and verbatim understanding of the information and their perceptions of the risks and benefits. Pictographs were associated with significantly (p < .05) greater likelihood of adequate gist and verbatim understanding compared with text and tables regardless of the participants' numeracy. Parents who received the information in pictograph format perceived the risks to be lower and the benefits to be higher compared with the other formats (p < .001). Furthermore, compared with text and tables, pictographs were perceived as more "effective," "helpful," and "trustworthy" in presenting risk/benefit information. These results underscore the difficulties associated with presenting risk/benefit information for clinical research but suggest a simple method for enhancing parents' informed understanding of the relevant statistics.

  1. Busulphan is active against neuroblastoma and medulloblastoma xenografts in athymic mice at clinically achievable plasma drug concentrations

    PubMed Central

    Boland, I; Vassal, G; Morizet, J; Terrier-Lacombe, M-J; Valteau-Couanet, D; Kalifa, C; Hartmann, O; Gouyette, A

    1999-01-01

    High-dose busulphan-containing chemotherapy regimens have shown high response rates in children with relapsed or refractory neuroblastoma, Ewing's sarcoma and medulloblastoma. However, the anti-tumour activity of busulfan as a single agent remains to be defined, and this was evaluated in athymic mice bearing advanced stage subcutaneous paediatric solid tumour xenografts. Because busulphan is highly insoluble in water, the use of several vehicles for enteral and parenteral administration was first investigated in terms of pharmacokinetics and toxicity. The highest bioavailability was obtained with busulphan in DMSO administered i.p. When busulphan was suspended in carboxymethylcellulose and given orally or i.p., the bioavailability was poor. Then, in the therapeutic experiments, busulphan in DMSO was administered i.p. on days 0 and 4. At the maximum tolerated total dose (50 mg kg−1), busulphan induced a significant tumour growth delay, ranging from 12 to 34 days in the three neuroblastomas evaluated and in one out of three medulloblastomas. At a dose level above the maximum tolerated dose, busulphan induced complete and partial tumour regressions. Busulphan was inactive in a peripheral primitive neuroectodermal tumour (PNET) xenograft. When busulphan pharmacokinetics in mice and humans were considered, the estimated systemic exposure at the therapeutically active dose in mice (113 μg h ml−1) was close to the mean total systemic exposure in children receiving high-dose busulphan (102.4 μg h ml−1). In conclusion, busulphan displayed a significant anti-tumour activity in neuroblastoma and medulloblastoma xenografts at plasma drug concentrations which can be achieved clinically in children receiving high-dose busulphan-containing regimens. 1999 Cancer Research Campaign PMID:10070870

  2. Preventing the transmission of pathogenic mitochondrial DNA mutations: can we achieve long-term benefits from germ-line gene transfer?

    PubMed Central

    Samuels, David C.; Wonnapinij, Passorn; Chinnery, Patrick F.

    2013-01-01

    Mitochondrial medicine is one of the few areas of genetic disease where germ-line transfer is being actively pursued as a treatment option. All of the germ-line transfer methods currently under development involve some carry-over of the maternal mitochondrial DNA (mtDNA) heteroplasmy, potentially delivering the pathogenic mutation to the offspring. Rapid changes in mtDNA heteroplasmy have been observed within a single generation, and so any ‘leakage’ of mutant mtDNA could lead to mtDNA disease in future generations, compromising the reproductive health of the first generation, and leading to repeated interventions in subsequent generations. To determine whether this is a real concern, we developed a model of mtDNA heteroplasmy inheritance by studying 87 mother–child pairs, and predicted the likely outcome of different levels of ‘mutant mtDNA leakage’ on subsequent maternal generations. This showed that, for a clinical threshold of 60%, reducing the proportion of mutant mtDNA to <5% dramatically reduces the chance of disease recurrence in subsequent generations, but transmitting >5% mutant mtDNA was associated with a significant chance of disease recurrence. Mutations with a lower clinical threshold were associated with a higher risk of recurrence. Our findings provide reassurance that, at least from an mtDNA perspective, methods currently under development have the potential to effectively eradicate pathogenic mtDNA mutations from subsequent generations. PMID:23297368

  3. Preventing the transmission of pathogenic mitochondrial DNA mutations: Can we achieve long-term benefits from germ-line gene transfer?

    PubMed

    Samuels, David C; Wonnapinij, Passorn; Chinnery, Patrick F

    2013-03-01

    Mitochondrial medicine is one of the few areas of genetic disease where germ-line transfer is being actively pursued as a treatment option. All of the germ-line transfer methods currently under development involve some carry-over of the maternal mitochondrial DNA (mtDNA) heteroplasmy, potentially delivering the pathogenic mutation to the offspring. Rapid changes in mtDNA heteroplasmy have been observed within a single generation, and so any 'leakage' of mutant mtDNA could lead to mtDNA disease in future generations, compromising the reproductive health of the first generation, and leading to repeated interventions in subsequent generations. To determine whether this is a real concern, we developed a model of mtDNA heteroplasmy inheritance by studying 87 mother-child pairs, and predicted the likely outcome of different levels of 'mutant mtDNA leakage' on subsequent maternal generations. This showed that, for a clinical threshold of 60%, reducing the proportion of mutant mtDNA to <5% dramatically reduces the chance of disease recurrence in subsequent generations, but transmitting >5% mutant mtDNA was associated with a significant chance of disease recurrence. Mutations with a lower clinical threshold were associated with a higher risk of recurrence. Our findings provide reassurance that, at least from an mtDNA perspective, methods currently under development have the potential to effectively eradicate pathogenic mtDNA mutations from subsequent generations.

  4. Achieving standardized medication data in clinical research studies: two approaches and applications for implementing RxNorm.

    PubMed

    Richesson, Rachel L; Smith, Susan B; Malloy, Jamie; Krischer, Jeffrey P

    2010-08-01

    The National Institutes of Health has proposed a roadmap for clinical research. Test projects of this roadmap include centralized data management for distributed research, the harmonization of clinical and research data, and the use of data standards throughout the research process. In 2003, RxNorm was named as a standard for codifying clinical drugs. Clinical researchers looking to implement RxNorm have few template implementation plans. Epidemiological studies and clinical trials (types of clinical research) have different requirements for model standards and best implementation tools. This paper highlights two different (epidemiological and intervention) clinical research projects, their unique requirements for a medication standard, the suitability of RxNorm as a standard for each, and application and process requirements for implementation. It is hoped that our experience of selecting and implementing the RxNorm standard to address varying study requirements in both domestic and international settings will be of value to other efforts. PMID:20703919

  5. Achieving standardized medication data in clinical research studies: two approaches and applications for implementing RxNorm.

    PubMed

    Richesson, Rachel L; Smith, Susan B; Malloy, Jamie; Krischer, Jeffrey P

    2010-08-01

    The National Institutes of Health has proposed a roadmap for clinical research. Test projects of this roadmap include centralized data management for distributed research, the harmonization of clinical and research data, and the use of data standards throughout the research process. In 2003, RxNorm was named as a standard for codifying clinical drugs. Clinical researchers looking to implement RxNorm have few template implementation plans. Epidemiological studies and clinical trials (types of clinical research) have different requirements for model standards and best implementation tools. This paper highlights two different (epidemiological and intervention) clinical research projects, their unique requirements for a medication standard, the suitability of RxNorm as a standard for each, and application and process requirements for implementation. It is hoped that our experience of selecting and implementing the RxNorm standard to address varying study requirements in both domestic and international settings will be of value to other efforts.

  6. Long-Term Treatment Outcomes of Patients Infected With Hepatitis C Virus: A Systematic Review and Meta-analysis of the Survival Benefit of Achieving a Sustained Virological Response

    PubMed Central

    Simmons, Bryony; Saleem, Jawaad; Heath, Katherine; Cooke, Graham S.; Hill, Andrew

    2015-01-01

    Background. Achievement of a sustained virologic response (SVR) after treatment for Hepatitis C infection is associated with improved outcomes. This meta-analysis aimed to determine the impact of SVR on long-term mortality risk compared with nonresponders in a range of populations. Methods. An electronic search identified all studies assessing all-cause mortality in SVR and non-SVR patients. Eligible articles were stratified into general, cirrhotic, and populations coinfected with human immunodeficiency virus. The adjusted hazard ratio (95% confidence interval [CI]) for mortality in patients achieving SVR vs non-SVR, and pooled estimates for the 5-year mortality in each group were calculated. Results. 31 studies (n = 33 360) were identified as suitable for inclusion. Median follow-up time was 5.4 years (interquartile range, 4.9–7.5) across all studies. The adjusted hazard ratio of mortality for patients achieving SVR vs non-SVR was 0.50 (95% CI, .37–.67) in the general population, 0.26 (95% CI, .18–.74) in the cirrhotic group, and 0.21 (.10–.45) in the coinfected group. The pooled 5-year mortality rates were significantly lower for patients achieving SVR compared with non-SVR in all 3 populations. Conclusions. The results suggest that there is a significant survival benefit of achieving an SVR compared with unsuccessful treatment in a range of populations infected with hepatitis C virus. PMID:25987643

  7. A Prospective, Descriptive Study to Assess the Clinical Benefits of Using Calendula officinalis Hydroglycolic Extract for the Topical Treatment of Diabetic Foot Ulcers.

    PubMed

    Buzzi, Marcelo; de Freitas, Franciele; Winter, Marcos

    2016-03-01

    Diabetic foot ulcers (DFUs) have a significant impact on patient quality of life. A prospective, descriptive pilot study was conducted between May 2012 and December 2013 through the dermatology outpatient unit in a Brazilian hospital to evaluate the clinical benefits of using Calendula officinalis hydroglycolic extract in the treatment of DFUs. Patients diagnosed with a stable neuropathic ulcer of >3 months' duration; ranging in size from 0.5-40 cm(2); without osteomyelitis, gangrene, bone exposure, cancer, or deep tissue infection; ages 18-90 years; with adequate glycemic control and no history of an allergy to C. officinalis were enrolled. Patients provided demographic and diabetes-related information and were evaluated biweekly for 30 weeks or until healing (ie, full epithelialization with no wound drainage). DFUs were measured and clinically examined for microbiological flora and presence of odor, tissue type (eg, granulation, fibrin sloth, necrosis), exudate, and retraction rate using planimetry images. Patients' blood tests and neuropathic pain assessment (the latter by clinician-directed questionnaire) were performed at baseline and the end of treatment; pain also was assessed during dressing changes using a 10-point rating scale. Patients' ulcers were treated twice daily with C. officinalis hydroglycolic extract spray solution and covered with saline-moistened, sterile, nonadherent gauze and bandages followed by foot offloading with adequate protective footwear. Patients received their first treatment in the clinic then performed care at home. From a potential population of 109 patients, 25 did not meet the inclusion criteria. Of the remaining 84 participants enrolled, 43 withdrew before study completion; cited reasons included lost to follow-up (16), medical judgment (2), failure to attend >3 scheduled visits (17), protocol violation (5), and death (3). Forty-one (41) - 17 women, average age 62 years (range 44-82 years), average glycemic level 153 mg

  8. A Prospective, Descriptive Study to Assess the Clinical Benefits of Using Calendula officinalis Hydroglycolic Extract for the Topical Treatment of Diabetic Foot Ulcers.

    PubMed

    Buzzi, Marcelo; de Freitas, Franciele; Winter, Marcos

    2016-03-01

    Diabetic foot ulcers (DFUs) have a significant impact on patient quality of life. A prospective, descriptive pilot study was conducted between May 2012 and December 2013 through the dermatology outpatient unit in a Brazilian hospital to evaluate the clinical benefits of using Calendula officinalis hydroglycolic extract in the treatment of DFUs. Patients diagnosed with a stable neuropathic ulcer of >3 months' duration; ranging in size from 0.5-40 cm(2); without osteomyelitis, gangrene, bone exposure, cancer, or deep tissue infection; ages 18-90 years; with adequate glycemic control and no history of an allergy to C. officinalis were enrolled. Patients provided demographic and diabetes-related information and were evaluated biweekly for 30 weeks or until healing (ie, full epithelialization with no wound drainage). DFUs were measured and clinically examined for microbiological flora and presence of odor, tissue type (eg, granulation, fibrin sloth, necrosis), exudate, and retraction rate using planimetry images. Patients' blood tests and neuropathic pain assessment (the latter by clinician-directed questionnaire) were performed at baseline and the end of treatment; pain also was assessed during dressing changes using a 10-point rating scale. Patients' ulcers were treated twice daily with C. officinalis hydroglycolic extract spray solution and covered with saline-moistened, sterile, nonadherent gauze and bandages followed by foot offloading with adequate protective footwear. Patients received their first treatment in the clinic then performed care at home. From a potential population of 109 patients, 25 did not meet the inclusion criteria. Of the remaining 84 participants enrolled, 43 withdrew before study completion; cited reasons included lost to follow-up (16), medical judgment (2), failure to attend >3 scheduled visits (17), protocol violation (5), and death (3). Forty-one (41) - 17 women, average age 62 years (range 44-82 years), average glycemic level 153 mg

  9. Achieving appropriate design for developing world heath care: the case of a low-cost autoclave for primary health clinics.

    PubMed

    Cho, Hallie S; Tao, Gregory D; Winter, Amos

    2012-01-01

    In developing world health clinics, incidence of surgical site infection is 2 to 10 times higher than in developed world hospitals. This paper identifies lack of availability of appropriately designed, low-cost autoclaves in developing world health clinics as a major contributing factor to the dramatic gap in surgical site infection rates. The paper describes the process of developing a low-cost autoclave that addresses the unique challenges faced by developing world primary health clinics and discusses how appropriateness of design was determined. The resulting pressure cooker-based autoclave design was fabricated and tested against the CDC specifications. Twelve partnering clinics in Nepal trialed these autoclaves from July until December 2012.

  10. Nonlinear speech analysis algorithms mapped to a standard metric achieve clinically useful quantification of average Parkinson's disease symptom severity

    PubMed Central

    Tsanas, Athanasios; Little, Max A.; McSharry, Patrick E.; Ramig, Lorraine O.

    2011-01-01

    The standard reference clinical score quantifying average Parkinson's disease (PD) symptom severity is the Unified Parkinson's Disease Rating Scale (UPDRS). At present, UPDRS is determined by the subjective clinical evaluation of the patient's ability to adequately cope with a range of tasks. In this study, we extend recent findings that UPDRS can be objectively assessed to clinically useful accuracy using simple, self-administered speech tests, without requiring the patient's physical presence in the clinic. We apply a wide range of known speech signal processing algorithms to a large database (approx. 6000 recordings from 42 PD patients, recruited to a six-month, multi-centre trial) and propose a number of novel, nonlinear signal processing algorithms which reveal pathological characteristics in PD more accurately than existing approaches. Robust feature selection algorithms select the optimal subset of these algorithms, which is fed into non-parametric regression and classification algorithms, mapping the signal processing algorithm outputs to UPDRS. We demonstrate rapid, accurate replication of the UPDRS assessment with clinically useful accuracy (about 2 UPDRS points difference from the clinicians' estimates, p < 0.001). This study supports the viability of frequent, remote, cost-effective, objective, accurate UPDRS telemonitoring based on self-administered speech tests. This technology could facilitate large-scale clinical trials into novel PD treatments. PMID:21084338

  11. Integrated NY-ESO-1 antibody and CD8+ T-cell responses correlate with clinical benefit in advanced melanoma patients treated with ipilimumab.

    PubMed

    Yuan, Jianda; Adamow, Matthew; Ginsberg, Brian A; Rasalan, Teresa S; Ritter, Erika; Gallardo, Humilidad F; Xu, Yinyan; Pogoriler, Evelina; Terzulli, Stephanie L; Kuk, Deborah; Panageas, Katherine S; Ritter, Gerd; Sznol, Mario; Halaban, Ruth; Jungbluth, Achim A; Allison, James P; Old, Lloyd J; Wolchok, Jedd D; Gnjatic, Sacha

    2011-10-01

    Ipilimumab, a monoclonal antibody against cytotoxic T lymphocyte antigen 4 (CTLA-4), has been shown to improve survival in patients with advanced metastatic melanoma. It also enhances immunity to NY-ESO-1, a cancer/testis antigen expressed in a subset of patients with melanoma. To characterize the association between immune response and clinical outcome, we first analyzed NY-ESO-1 serum antibody by ELISA in 144 ipilimumab-treated patients with melanoma and found 22 of 140 (16%) seropositive at baseline and 31 of 144 (22%) seropositive following treatment. These NY-ESO-1-seropositive patients had a greater likelihood of experiencing clinical benefit 24 wk after ipilimumab treatment than NY-ESO-1-seronegative patients (P = 0.02, relative risk = 1.8, two-tailed Fisher test). To understand why some patients with NY-ESO-1 antibody failed to experience clinical benefit, we analyzed NY-ESO-1-specific CD4(+) and CD8(+) T-cell responses by intracellular multicytokine staining in 20 NY-ESO-1-seropositive patients and found a surprising dissociation between NY-ESO-1 antibody and CD8 responses in some patients. NY-ESO-1-seropositive patients with associated CD8(+) T cells experienced more frequent clinical benefit (10 of 13; 77%) than those with undetectable CD8(+) T-cell response (one of seven; 14%; P = 0.02; relative risk = 5.4, two-tailed Fisher test), as well as a significant survival advantage (P = 0.01; hazard ratio = 0.2, time-dependent Cox model). Together, our data suggest that integrated NY-ESO-1 immune responses may have predictive value for ipilimumab treatment and argue for prospective studies in patients with established NY-ESO-1 immunity. The current findings provide a strong rationale for the clinical use of modulators of immunosuppression with concurrent approaches to favor tumor antigen-specific immune responses, such as vaccines or adoptive transfer, in patients with cancer.

  12. 21 CFR 50.53 - Clinical investigations involving greater than minimal risk and no prospect of direct benefit to...

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... Safeguards for Children in Clinical Investigations § 50.53 Clinical investigations involving greater than... in §§ 50.1 and 56.101 of this chapter in which more than minimal risk to children is presented by an... involve children as subjects only if the IRB finds and documents that: (a) The risk represents a...

  13. ECOSYSTEM RESTORATION: PRIORITIZATION TO ACHIEVE EMERGENT BENEFITS

    EPA Science Inventory

    The declining ability of ecosystems to support themselves and the demands placed on them is not new. Initial efforts to counteract these effects and trends focused on individual species (e.g., Endangered Species Act) or environmental media (e.g., Clean Water Act, Clean Air Act)....

  14. Achieving joint benefits from joint implementation

    SciTech Connect

    Moomaw, W.R.

    1995-11-01

    Joint Implementation (JI) appears to have been born with Applied Energy Services Guatemala project in 1988. That project, to plant 52 million trees, protect existing forests from cutting and fire, and enhance rural development, is being implemented by CARE Guatemala to offset 120 per cent of the emissions of a small coal burning power plant that has been built in Connecticut. Since that time, several utilities and governments have initiated additional projects. Not all of these necessarily consist of tree planting in other countries, but may consist of energy efficiency or energy conservation programs designed to reduce carbon emissions by at least as much as the additional releases from a new facility. All JI projects share the characteristic of linking the release of greenhouse gases in an industrial country with an offset that reduces or absorbs a comparable amount in another country. The emitter in the industrial country is willing to pay for the reduction elsewhere because costs are less than they would be at home.

  15. The Royal College of Physicians Simms Lecture, 6 December 2011: clinical research networks and the benefits of intensive healthcare systems.

    PubMed

    Selby, Peter; Kaplan, Richard; Cameron, David; Cooper, Matthew; Seymour, Matthew

    2012-10-01

    Clinical research contributes to the evidence base for the planning of improved healthcare services and creates an excellent environment for the delivery of healthcare and the recruitment and retention of excellent and well-motivated staff. In this paper, we consider the evidence that a research-intensive healthcare system might yield improved outcomes as a result of the impact of the process of research on the provision of care. We review progress in establishing clinical research networks for cancer and the evidence of the impact of the conduct of clinical cancer research in the National Health Service.

  16. Using perceptual mapping methods to understand gender differences in perceived barriers and benefits of clinical research participation in urban minority HIV+ patients.

    PubMed

    Bass, Sarah Bauerle; Wolak, Caitlin; Greener, Judith; Tedaldi, Ellen; Nanavati, Aasit; Ruppert, Katey; Gordon, Thomas F

    2016-01-01

    Minority participation in HIV clinical trials research is critical to understanding the impact of medications or behavioral interventions, but little is known about gender differences in perceptions of participation. We surveyed 50 minority HIV+ patients from an urban clinic to assess perceived risks/benefits of clinical trial research participation and used innovative marketing methods to analyze results. Perceptual mapping and vector message-modeling, a method that creates 3-D models representing how groups conceptualize elements, were used to assess how male and female participants could be motivated to participate. Results showed men farther away from participation and more concerned with HIV disclosure and experimentation than women. Men expressed distrust of the medical system, doubted HIV's origin, and knew less about research implementation. Women were closer to participation in both behavior and medical trials and perceived medication issues as more significant, including fear of losing medication stability, medications not working, being in the placebo group, and experiencing side effects. Vector modeling shows that messages would need to focus on different aspects of clinical research for men and women and that interventions aimed at minority HIV+ patients to encourage clinical trial participation would need to be targeted to their unique perceptions. Understanding gender perceptions of HIV clinical research has significant implications for targeting messages to increase minority participation. PMID:26572215

  17. Using perceptual mapping methods to understand gender differences in perceived barriers and benefits of clinical research participation in urban minority HIV+ patients.

    PubMed

    Bass, Sarah Bauerle; Wolak, Caitlin; Greener, Judith; Tedaldi, Ellen; Nanavati, Aasit; Ruppert, Katey; Gordon, Thomas F

    2016-01-01

    Minority participation in HIV clinical trials research is critical to understanding the impact of medications or behavioral interventions, but little is known about gender differences in perceptions of participation. We surveyed 50 minority HIV+ patients from an urban clinic to assess perceived risks/benefits of clinical trial research participation and used innovative marketing methods to analyze results. Perceptual mapping and vector message-modeling, a method that creates 3-D models representing how groups conceptualize elements, were used to assess how male and female participants could be motivated to participate. Results showed men farther away from participation and more concerned with HIV disclosure and experimentation than women. Men expressed distrust of the medical system, doubted HIV's origin, and knew less about research implementation. Women were closer to participation in both behavior and medical trials and perceived medication issues as more significant, including fear of losing medication stability, medications not working, being in the placebo group, and experiencing side effects. Vector modeling shows that messages would need to focus on different aspects of clinical research for men and women and that interventions aimed at minority HIV+ patients to encourage clinical trial participation would need to be targeted to their unique perceptions. Understanding gender perceptions of HIV clinical research has significant implications for targeting messages to increase minority participation.

  18. Clinically significant responses achieved with romidepsin across disease compartments in patients with cutaneous T-cell lymphoma

    PubMed Central

    Kim, Ellen J.; Kim, Youn H.; Rook, Alain H.; Lerner, Adam; Duvic, Madeleine; Reddy, Sunil; Robak, Tadeusz; Becker, Jürgen C.; Samtsov, Alexey; McCulloch, William; Waksman, Joel; Whittaker, Sean

    2015-01-01

    Cutaneous T-cell lymphoma (CTCL) is a rare heterogeneous group of non-Hodgkin lymphomas that arises in the skin but can progress to systemic disease (lymph nodes, blood, viscera). Historically, in clinical trials of CTCL there has been little consistency in how responses were defined in each disease “compartment”; some studies only assessed responses in the skin. The histone deacetylase inhibitor romidepsin is approved by the US Food and Drug Administration for the treatment of CTCL in patients who have received at least one prior systemic therapy. Phase II studies that led to approval used rigorous composite end points that incorporated disease assessments in all compartments. The objective of this analysis was to thoroughly examine the activity of romidepsin within each disease compartment in patients with CTCL. Romidepsin was shown to have clinical activity across disease compartments and is suitable for use in patients with CTCL having skin involvement only, erythroderma, lymphadenopathy and/or blood involvement. PMID:25791237

  19. Clinically significant responses achieved with romidepsin across disease compartments in patients with cutaneous T-cell lymphoma.

    PubMed

    Kim, Ellen J; Kim, Youn H; Rook, Alain H; Lerner, Adam; Duvic, Madeleine; Reddy, Sunil; Robak, Tadeusz; Becker, Jürgen C; Samtsov, Alexey; McCulloch, William; Waksman, Joel; Whittaker, Sean

    2015-01-01

    Cutaneous T-cell lymphoma (CTCL) is a rare heterogeneous group of non-Hodgkin lymphomas that arises in the skin but can progress to systemic disease (lymph nodes, blood, viscera). Historically, in clinical trials of CTCL there has been little consistency in how responses were defined in each disease "compartment"; some studies only assessed responses in the skin. The histone deacetylase inhibitor romidepsin is approved by the US Food and Drug Administration for the treatment of CTCL in patients who have received at least one prior systemic therapy. Phase II studies that led to approval used rigorous composite end points that incorporated disease assessments in all compartments. The objective of this analysis was to thoroughly examine the activity of romidepsin within each disease compartment in patients with CTCL. Romidepsin was shown to have clinical activity across disease compartments and is suitable for use in patients with CTCL having skin involvement only, erythroderma, lymphadenopathy and/or blood involvement.

  20. Routine chest radiographs in the surgical intensive care unit: can we change clinical habits with no proven benefit?

    PubMed

    Velicković, Jelena V; Hajdarević, Sanela A; Palibrk, Ivan G; Janić, Natasa R; Djukanović, Marija; Miljković, Bojana; Velicković, Dejan M; Bumbasirević, Vesna

    2013-01-01

    Daily routine chest radiographs (CR) are commonly performed in surgical ICU. Unnecessary CR increase costs and expose the staff and the patients to radiation risk. The goal of our study was to estimate the value of daily routine CR in the ICU and to determine the correlation between CR and physical findings in surgical ICU patients. Prospective observational study was conducted during period of two months at the ICU department at the Clinic for Digestive Surgery, Clinical Center of Serbia, Belgrade. It included 97 consecutive patients who underwent digestive surgery and stayed at the ICU for at least two days. During their ICU stay, CRs were obtained as a clinical routine or to monitor lung pathology. Patients were followed daily, and CRs (as the proportion of positive findings) were compared with physical examination and clinical presentation. A total of 717 CRs were obtained, median number per patient was 4.0 (2.0-7.0). Proportion of positive findings was significantly higher comparing to auscultation until the sixth day of ICU stay. There was no difference in CR findings from day to day after the sixth day. Therapeutic efficacy of CRs was low as only 56 (7.8%) resulted in a change of patient management. We conclude that daily routine CRs are justified in the first six days of ICU stay, and after that time they show no advantages over clinical examination. PMID:24669579

  1. Lack of radiological and clinical benefit over two years of low dose prednisolone for rheumatoid arthritis: results of a randomised controlled trial

    PubMed Central

    Capell, H; Madhok, R; Hunter, J; Porter, D; Morrison, E; Larkin, J; Thomson, E; Hampson, R; Poon, F

    2004-01-01

    Background: Evidence for disease modifying activity of low dose corticosteroid treatment in rheumatoid arthritis is contradictory. Studies showing radiological benefit suggest that continued treatment is required to sustain the effect. Objective: To evaluate the effect of low dose oral prednisolone in early rheumatoid arthritis on disease activity over two years. Design: Double blind placebo controlled trial. Methods: Patients with rheumatoid arthritis, duration <3 years (n = 167), were started on a disease modifying antirheumatic drug (DMARD; sulphasalazine) and allocated by stratified randomisation to prednisolone 7 mg/day or placebo. Primary outcome measure was radiological damage, assessed by the modified Sharp method. Clinical benefit was a secondary outcome. A proactive approach to identifying and treating corticosteroid adverse events was adopted. Patients who discontinued sulphasalazine were offered an alternative DMARD. Results: 90 of 257 patients eligible for the study refused to participate (more women than men). Of those enrolled, 84% were seropositive for rheumatoid factor, median age 56 years, median disease duration 12 months, female to male ratio 1.8:1. Prednisolone was given to 84 patients; of these 73% continued prednisolone and 70% sulphasalazine at 2 years. Of the 83 patients on placebo, 80% continued placebo and 64% sulphasalazine at 2 years. There were no significant differences in radiological score or clinical and laboratory measures at 0 and 2 years. Conclusions: Low dose prednisolone conferred no radiological or clinical benefit on patients maintained on a DMARD over two years. Low dose corticosteroids have no role in the routine management of rheumatoid arthritis treated with conventional disease modifying drugs. PMID:15194574

  2. 21 CFR 50.53 - Clinical investigations involving greater than minimal risk and no prospect of direct benefit to...

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... knowledge about the subjects' disorder or condition. 50.53 Section 50.53 Food and Drugs FOOD AND DRUG... knowledge about the subjects' disorder or condition. Any clinical investigation within the scope described... knowledge about the subjects' disorder or condition that is of vital importance for the understanding...

  3. The Benefits of Multidisciplinary Learning in Clinical Practice for Law, Finance, and Social Work Students: An Australian Experience

    ERIC Educational Resources Information Center

    Hyams, Ross; Brown, Grace; Foster, Richard

    2013-01-01

    In July 2010, the faculties of Law, Business and Economics, and Medicine at Monash University, Australia commenced placing law, finance, and social work students in a multidisciplinary clinic at a community legal service operated by the University. Students from the three disciplines began seeing legal service clients at the same time as a team.…

  4. Achievement of recommended glucose and blood pressure targets in patients with type 2 diabetes and hypertension in clinical practice – study rationale and protocol of DIALOGUE

    PubMed Central

    2012-01-01

    Background Patients with type 2 diabetes have 2–4 times greater risk for cardiovascular morbidity and mortality than those without, and this is even further aggravated if they also suffer from hypertension. Unfortunately, less than one third of hypertensive diabetic patients meet blood pressure targets, and more than half fail to achieve target HbA1c values. Thus, appropriate blood pressure and glucose control are of utmost importance. Since treatment sometimes fails in clinical practice while clinical trials generally suggest good efficacy, data from daily clinical practice, especially with regard to the use of newly developed anti-diabetic and anti-hypertensive compounds in unselected patient populations, are essential. The DIALOGUE registry aims to close this important gap by evaluating different treatment approaches in hypertensive type 2 diabetic patients with respect to their effectiveness and tolerability and their impact on outcomes. In addition, DIALOGUE is the first registry to determine treatment success based on the new individualized treatment targets recommended by the ADA and the EASD. Methods DIALOGUE is a prospective observational German multicentre registry and will enrol 10,000 patients with both diabetes and hypertension in up to 700 sites. After a baseline visit, further documentations are scheduled at 6, 12 and 24 months. There are two co-primary objectives referring to the most recent guidelines for the treatment of diabetes and hypertension: 1) individual HbA1c goal achievement with respect to anti-diabetic pharmacotherapy and 2) individual blood pressure goal achievement with different antihypertensive treatments. Among the secondary objectives the rate of major cardio-vascular and cerebro-vascular events (MACCE) and the rate of hospitalizations are the most important. Conclusion The registry will be able to gain insights into the reasons for the obvious gap between the demonstrated efficacy and safety of anti-diabetic and anti

  5. Addressing the expected survival benefit for clinical trial design in metastatic castration-resistant prostate cancer: Sensitivity analysis of randomized trials.

    PubMed

    Massari, Francesco; Modena, Alessandra; Ciccarese, Chiara; Pilotto, Sara; Maines, Francesca; Bracarda, Sergio; Sperduti, Isabella; Giannarelli, Diana; Carlini, Paolo; Santini, Daniele; Tortora, Giampaolo; Porta, Camillo; Bria, Emilio

    2016-02-01

    We performed a sensitivity analysis, cumulating all randomized clinical trials (RCTs) in which patients with metastatic castration-resistant prostate cancer (mCRPC) received systemic therapy, to evaluate if the comparison of RCTs may drive to biased survival estimations. An overall survival (OS) significant difference according to therapeutic strategy was more likely be determined in RCTs evaluating hormonal drugs versus those studies testing immunotherapy, chemotherapy or other strategies. With regard to control arm, an OS significant effect was found for placebo-controlled trials versus studies comparing experimental treatment with active therapies. Finally, regarding to docetaxel (DOC) timing, the OS benefit was more likely to be proved in Post-DOC setting in comparison with DOC and Pre-DOC. These data suggest that clinical trial design should take into account new benchmarks such as the type of treatment strategy, the choice of the comparator and the phase of the disease in relation to the administration of standard chemotherapy.

  6. Rapid diagnostics of tuberculosis and drug resistance in the industrialized world: clinical and public health benefits and barriers to implementation

    PubMed Central

    2013-01-01

    In this article, we give an overview of new technologies for the diagnosis of tuberculosis (TB) and drug resistance, consider their advantages over existing methodologies, broad issues of cost, cost-effectiveness and programmatic implementation, and their clinical as well as public health impact, focusing on the industrialized world. Molecular nucleic-acid amplification diagnostic systems have high specificity for TB diagnosis (and rifampicin resistance) but sensitivity for TB detection is more variable. Nevertheless, it is possible to diagnose TB and rifampicin resistance within a day and commercial automated systems make this possible with minimal training. Although studies are limited, these systems appear to be cost-effective. Most of these tools are of value clinically and for public health use. For example, whole genome sequencing of Mycobacterium tuberculosis offers a powerful new approach to the identification of drug resistance and to map transmission at a community and population level. PMID:23987891

  7. Digital management and regulatory submission of medical images from clinical trials: role and benefits of the core laboratory

    NASA Astrophysics Data System (ADS)

    Robbins, William L.; Conklin, James J.

    1995-10-01

    Medical images (angiography, CT, MRI, nuclear medicine, ultrasound, x ray) play an increasingly important role in the clinical development and regulatory review process for pharmaceuticals and medical devices. Since medical images are increasingly acquired and archived digitally, or are readily digitized from film, they can be visualized, processed and analyzed in a variety of ways using digital image processing and display technology. Moreover, with image-based data management and data visualization tools, medical images can be electronically organized and submitted to the U.S. Food and Drug Administration (FDA) for review. The collection, processing, analysis, archival, and submission of medical images in a digital format versus an analog (film-based) format presents both challenges and opportunities for the clinical and regulatory information management specialist. The medical imaging 'core laboratory' is an important resource for clinical trials and regulatory submissions involving medical imaging data. Use of digital imaging technology within a core laboratory can increase efficiency and decrease overall costs in the image data management and regulatory review process.

  8. Past and present achievements, and future direction of the Gastrointestinal Oncology Study Group (GIOSG), a Division of Japan Clinical Oncology Group (JCOG).

    PubMed

    Boku, Narikazu

    2011-12-01

    Initially, Gastrointestinal Study Group in Japan Clinical Oncology Group (GIOSG/JCOG) focused on gastric cancer. In 1980s, fluoropyrimidine, cisplatin and mitomycin C were key drugs. A randomized Phase II trial (JCOG8501) comparing futrafur plus mitomycin C and uracil plus futrafur and mitomycin C showed a higher response rate of uracil plus futrafur and mitomycin C than futrafur plus mitomycin C. From the results of two Phase II trials of etoposide, adriamycin and cisplatin, and cisplatin plus 5-fluorouracil, uracil plus futrafur and mitomycin C and cisplatin plus 5-fluorouracil were adopted for the test arms of the Phase III trial (JCOG9205) comparing with continuous infusion of 5-fluorouracil as a control arm. Neither cisplatin plus 5-fluorouracil nor uracil plus futrafur and mitomycin C showed a survival benefit over continuous infusion of 5-fluorouracil. In late 1990s, new agents, irinotecan and S-1, were developed for gastric cancer in Japan. GIOSG conducted a Phase III trial (JCOG9912) investigating superiority of irinotecan plus cisplatin and non-inferiority of monotherapy with S-1 compared with continuous infusion of 5-fluorouracil, and S-1 succeeded in showing non-inferiority. Then, SPIRITS trial showed a survival benefit of S-1 plus cisplatin over S-1, resulting in the establishment of a standard care for advanced gastric cancer in Japan. GIOSG have merged with Gastric Cancer Study Group as the Stomach Cancer Study Group (SCSG) from 2011. Recent progress in the development of new drugs has been remarkable. From the point of the roles shared with many other study groups for clinical trials, including registration trials of new drugs conducted by pharmaceutical companies, SCSG should recognize its role and conduct clinical trials with high quality for establishing new standard treatment.

  9. Translating the therapeutic potential of neurotrophic factors to clinical 'proof of concept': a personal saga achieving a career-long quest.

    PubMed

    Bartus, Raymond T

    2012-11-01

    While the therapeutic potential of neurotrophic factors has been well-recognized for over two decades, attempts to translate that potential to the clinic have been disappointing, largely due to significant delivery obstacles. Similarly, gene therapy (or gene transfer) emerged as a potentially powerful, new therapeutic approach nearly two decades ago and despite its promise, also suffered serious setbacks when applied to the human clinic. As advances continue to be made in both fields, ironically, they may now be poised to complement each other to produce a translational breakthrough. The accumulated data argue that gene transfer provides the 'enabling technology' that can solve the age-old delivery problems that have plagued the translation of neurotrophic factors as treatments for chronic central nervous system diseases. A leading translational program applying gene transfer to deliver a neurotrophic factor to rejuvenate and protect degenerating human neurons is CERE-120 (AAV2-NRTN). To date, over two dozen nonclinical studies and three clinical trials have been completed. A fourth (pivotal) clinical trial has completed all dosing and is currently evaluating safety and efficacy. In total, eighty Parkinson's disease (PD) subjects have thus far been dosed with CERE-120 (some 7 years ago), representing over 250 cumulative patient-years of exposure, with no serious safety issues identified. In a completed sham-surgery, double-blinded controlled trial, though the primary endpoint (the Unified Parkinson's Disease Rating Scale (UDPRS) motor off score measured at 12 months) did not show benefit from CERE-120, several important motor and quality of life measurements did, including the same UPDRS-motor-off score, pre-specified to also be measured at a longer, 18-month post-dosing time point. Importantly, not a single measurement favored the sham control group. This study therefore, provided important, well-controlled evidence establishing 'clinical proof of concept' for

  10. EDTA chelation reappraisal following new clinical trials and regular use in millions of patients: review of preliminary findings and risk/benefit assessment.

    PubMed

    Born, Tammy; Kontoghiorghe, Christina N; Spyrou, Aspasia; Kolnagou, Annita; Kontoghiorghes, George J

    2013-01-01

    EDTA chelation therapy is regularly used in thousands of patients worldwide. An FDA approval of more than 50 years ago for heavy metal detoxification prompted many physicians to use EDTA as an alternative medicine for many categories of patients. Recently, NIH initiated the so-called Trial to Assess Chelation Therapy (TACT), which has been designed to evaluate whether EDTA and high dose oral vitamins and mineral therapy could offer clinical, quality of life, and economic benefits for patients with a previous myocardial infraction. A 50% reduction of urinary Pb and improvement of systolic blood pressure was observed in 33 cardiovascular patients following 20 iv administrations. In another study involving 15 patients of different categories, EDTA also has been shown to be an effective and nontoxic chelator for the removal of xenobiotic metals such as Pb, Cd, Ni and Al. Administration of iv EDTA on weekly basis appears to be a sufficient and nontoxic protocol for treating patients with suspected overload and toxicity of xenobiotic metals especially Pb and Cd. The causative effect of xenobiotic metals in cancer, cardiovascular, neurodegenerative, renal and other diseases needs further investigation. Similarly, the use of EDTA chelation therapy in other conditions, which are not related to xenobiotic metal toxicity needs further investigation and confirmation of therapeutic use from controlled randomized clinical trials. Metal balance and drug interaction studies are required to clarify the risk/benefit assessment for the long term use of EDTA in patients with excess xenobiotic metal toxicity and in other conditions.

  11. EDTA chelation reappraisal following new clinical trials and regular use in millions of patients: review of preliminary findings and risk/benefit assessment.

    PubMed

    Born, Tammy; Kontoghiorghe, Christina N; Spyrou, Aspasia; Kolnagou, Annita; Kontoghiorghes, George J

    2013-01-01

    EDTA chelation therapy is regularly used in thousands of patients worldwide. An FDA approval of more than 50 years ago for heavy metal detoxification prompted many physicians to use EDTA as an alternative medicine for many categories of patients. Recently, NIH initiated the so-called Trial to Assess Chelation Therapy (TACT), which has been designed to evaluate whether EDTA and high dose oral vitamins and mineral therapy could offer clinical, quality of life, and economic benefits for patients with a previous myocardial infraction. A 50% reduction of urinary Pb and improvement of systolic blood pressure was observed in 33 cardiovascular patients following 20 iv administrations. In another study involving 15 patients of different categories, EDTA also has been shown to be an effective and nontoxic chelator for the removal of xenobiotic metals such as Pb, Cd, Ni and Al. Administration of iv EDTA on weekly basis appears to be a sufficient and nontoxic protocol for treating patients with suspected overload and toxicity of xenobiotic metals especially Pb and Cd. The causative effect of xenobiotic metals in cancer, cardiovascular, neurodegenerative, renal and other diseases needs further investigation. Similarly, the use of EDTA chelation therapy in other conditions, which are not related to xenobiotic metal toxicity needs further investigation and confirmation of therapeutic use from controlled randomized clinical trials. Metal balance and drug interaction studies are required to clarify the risk/benefit assessment for the long term use of EDTA in patients with excess xenobiotic metal toxicity and in other conditions. PMID:22991933

  12. Benefits of post-operative oral protein supplementation in gastrointestinal surgery patients: A systematic review of clinical trials

    PubMed Central

    Crickmer, Mike; Dunne, Colum P; O’Regan, Andrew; Coffey, J Calvin; Dunne, Suzanne S

    2016-01-01

    AIM: To evaluate published trials examining oral post-operative protein supplementation in patients having undergone gastrointestinal surgery and assessment of reported results. METHODS: Database searches (MEDLINE, BIOSIS, EMBASE, Cochrane Trials, Cinahl, and CAB), searches of reference lists of relevant papers, and expert referral were used to identify prospective randomized controlled clinical trials. The following terms were used to locate articles: “oral’’ or “enteral’’ and “postoperative care’’ or “post-surgical’’ and “proteins’’ or “milk proteins’’ or “dietary proteins’’ or “dietary supplements’’ or “nutritional supplements’’. In databases that allowed added limitations, results were limited to clinical trials that studied humans, and publications between 1990 and 2014. Quality of collated studies was evaluated using a qualitative assessment tool and the collective results interpreted. RESULTS: Searches identified 629 papers of which, following review, 7 were deemed eligible for qualitative evaluation. Protein supplementation does not appear to affect mortality but does reduce weight loss, and improve nutritional status. Reduction in grip strength deterioration was observed in a majority of studies, and approximately half of the studies described reduced complication rates. No changes in duration of hospital stay or plasma protein levels were reported. There is evidence to suggest that protein supplementation should be routinely provided post-operatively to this population. However, despite comprehensive searches, clinical trials that varied only the amount of protein provided via oral nutritional supplements (discrete from other nutritional components) were not found. At present, there is some evidence to support routinely prescribed oral nutritional supplements that contain protein for gastrointestinal surgery patients in the immediate post-operative stage. CONCLUSION: The optimal level of protein

  13. The Clinical and Economic Benefits of Co-Testing Versus Primary HPV Testing for Cervical Cancer Screening: A Modeling Analysis

    PubMed Central

    Felix, Juan C.; Lacey, Michael J.; Lenhart, Gregory M.; Spitzer, Mark; Kulkarni, Rucha

    2016-01-01

    Abstract Background: Consensus United States cervical cancer screening guidelines recommend use of combination Pap plus human papillomavirus (HPV) testing for women aged 30 to 65 years. An HPV test was approved by the Food and Drug Administration in 2014 for primary cervical cancer screening in women age 25 years and older. Here, we present the results of clinical-economic comparisons of Pap plus HPV mRNA testing including genotyping for HPV 16/18 (co-testing) versus DNA-based primary HPV testing with HPV 16/18 genotyping and reflex cytology (HPV primary) for cervical cancer screening. Methods: A health state transition (Markov) model with 1-year cycling was developed using epidemiologic, clinical, and economic data from healthcare databases and published literature. A hypothetical cohort of one million women receiving triennial cervical cancer screening was simulated from ages 30 to 70 years. Screening strategies compared HPV primary to co-testing. Outcomes included total and incremental differences in costs, invasive cervical cancer (ICC) cases, ICC deaths, number of colposcopies, and quality-adjusted life years for cost-effectiveness calculations. Comprehensive sensitivity analyses were performed. Results: In a simulation cohort of one million 30-year-old women modeled up to age 70 years, the model predicted that screening with HPV primary testing instead of co-testing could lead to as many as 2,141 more ICC cases and 2,041 more ICC deaths. In the simulation, co-testing demonstrated a greater number of lifetime quality-adjusted life years (22,334) and yielded $39.0 million in savings compared with HPV primary, thereby conferring greater effectiveness at lower cost. Conclusions: Model results demonstrate that co-testing has the potential to provide improved clinical and economic outcomes when compared with HPV primary. While actual cost and outcome data are evaluated, these findings are relevant to U.S. healthcare payers and women's health policy advocates

  14. Prospective assessment of a gene signature potentially predictive of clinical benefit in metastatic melanoma patients following MAGE-A3 immunotherapeutic (PREDICT)

    PubMed Central

    Saiag, P.; Gutzmer, R.; Ascierto, P. A.; Maio, M.; Grob, J.-J.; Murawa, P.; Dreno, B.; Ross, M.; Weber, J.; Hauschild, A.; Rutkowski, P.; Testori, A.; Levchenko, E.; Enk, A.; Misery, L.; Vanden Abeele, C.; Vojtek, I.; Peeters, O.; Brichard, V. G.; Therasse, P.

    2016-01-01

    Background Genomic profiling of tumor tissue may aid in identifying predictive or prognostic gene signatures (GS) in some cancers. Retrospective gene expression profiling of melanoma and non-small-cell lung cancer led to the characterization of a GS associated with clinical benefit, including improved overall survival (OS), following immunization with the MAGE-A3 immunotherapeutic. The goal of the present study was to prospectively evaluate the predictive value of the previously characterized GS. Patients and methods An open-label prospective phase II trial (‘PREDICT’) in patients with MAGE-A3-positive unresectable stage IIIB-C/IV-M1a melanoma. Results Of 123 subjects who received the MAGE-A3 immunotherapeutic, 71 (58.7%) displayed the predictive GS (GS+). The 1-year OS rate was 83.1%/83.3% in the GS+/GS− populations. The rate of progression-free survival at 12 months was 5.8%/4.1% in GS+/GS− patients. The median time-to-treatment failure was 2.7/2.4 months (GS+/GS−). There was one complete response (GS−) and two partial responses (GS+). The MAGE-A3 immunotherapeutic was similarly immunogenic in both populations and had a clinically acceptable safety profile. Conclusion Treatment of patients with MAGE-A3-positive unresectable stage IIIB-C/IV-M1a melanoma with the MAGE-A3 immunotherapeutic demonstrated an overall 1-year OS rate of 83.5%. GS− and GS+ patients had similar 1-year OS rates, indicating that in this study, GS was not predictive of outcome. Unexpectedly, the objective response rate was lower in this study than in other studies carried out in the same setting with the MAGE-A3 immunotherapeutic. Investigation of a GS to predict clinical benefit to adjuvant MAGE-A3 immunotherapeutic treatment is ongoing in another melanoma study. This study is registered at www.clinicatrials.gov NCT00942162. PMID:27502712

  15. Clinical Benefits of Systemic Chemotherapy for Patients with Metastatic Pheochromocytomas or Sympathetic Extra-Adrenal Paragangliomas: Insights from the Largest Single Institutional Experience

    PubMed Central

    Ayala-Ramirez, Montserrat; Feng, Lei; Habra, Mouhammed A.; Rich, Thereasa; Dickson, Paxton V.; Perrier, Nancy; Phan, Alexandria; Waguespack, Steven; Patel, Shreyaskumar; Jimenez, Camilo

    2013-01-01

    Background The purpose of this study was to evaluate the clinical benefits of systemic chemotherapy for patients with metastatic pheochromocytomas or sympathetic paragangliomas by assessing reduction in tumor size, blood pressure, and improvement in overall survival. Methods We retrospectively reviewed the medical records of patients with metastatic pheochromocytomas-sympathetic paragangliomas who had received chemotherapy at The University of Texas MD Anderson Cancer Center Results Clinical benefit and overall survival (OS) were assessed. Of fifty-four patients treated with chemotherapy, fifty-two were evaluable for response. Seventeen (33%) experienced a response, defined as decreased or normalized blood pressure/decreased number and dosage of antihypertensive medications and/or reduced tumor size after the first chemotherapy regimen. The median OS time was 6.4 years (95 confidence interval (CI): 5.2–16.4) for responders and 3.7 (95% CI: 3.0–7.5) years for non-responders. Of patients who had synchronous metastatic disease, a positive response at 1 year after the start of chemotherapy was associated with a trend toward a longer overall survival (log-rank test, P-value =0.095). In a multivariate Cox proportional hazards model, the effect of response to chemotherapy on overall survival was significant (hazard ratio=0.22, 95% confidence interval: 0.05–1.0; P-value = 0.05). All responders had been treated with dacarbazine and cyclophosphamide. Vincristine was included for 14 responders and doxorubicin was included for 12 responders. We could not identify clinical factors that predicted response to chemotherapy. Conclusion Chemotherapy may decrease tumor size and facilitate blood pressure control in about 33% of patients with metastatic pheochromocytoma-sympathetic paraganglioma. These patients exhibit a longer survival. PMID:22006217

  16. Allergen-specific immunotherapy provides immediate, long-term and preventive clinical effects in children and adults: the effects of immunotherapy can be categorised by level of benefit -the centenary of allergen specific subcutaneous immunotherapy

    PubMed Central

    2012-01-01

    Allergen Specific Immunotherapy (SIT) for respiratory allergic diseases is able to significantly improve symptoms as well as reduce the need for symptomatic medication, but SIT also has the capacity for long-term clinical effects and plays a protective role against the development of further allergies and symptoms. The treatment acts on basic immunological mechanisms, and has the potential to change the pathological allergic immune response. In this paper we discuss some of the most important achievements in the documentation of the benefits of immunotherapy, over the last 2 decades, which have marked a period of extensive research on the clinical effects and immunological background of the mechanisms involved. The outcome of immunotherapy is described as different levels of benefit from early reduction in symptoms over progressive clinical effects during treatment to long-term effects after discontinuation of the treatment and prevention of asthma. The efficacy of SIT increases the longer it is continued and immunological changes lead to potential long-term benefits. SIT alone and not the symptomatic treatment nor other avoidance measures has so far been documented as the therapy with long-term or preventive potential. The allergic condition is driven by a subset of T-helper lymphocytes (Th2), which are characterised by the production of cytokines like IL-4, and IL-5. Immunological changes following SIT lead to potential curative effects. One mechanism whereby immunotherapy suppresses the allergic response is through increased production of IgG4 antibodies. Induction of specific IgG4 is able to influence the allergic response in different ways and is related to immunological effector mechanisms, also responsible for the reduced late phase hyperreactivity and ongoing allergic inflammation. SIT is the only treatment which interferes with the basic pathophysiological mechanisms of the allergic disease, thereby creating the potential for changes in the long

  17. Short‐Term Efficacy Reliably Predicts Long‐Term Clinical Benefit in Rheumatoid Arthritis Clinical Trials as Demonstrated by Model‐Based Meta‐Analysis

    PubMed Central

    Zhu, Rui; Xiao, Jim; Davis, John C.; Mandema, Jaap W.; Jin, Jin Y.; Tang, Meina T.

    2015-01-01

    Abstract The objective of this study was to assess the relationship between short‐term and long‐term treatment effects measured by the American College of Rheumatology (ACR) 50 responses and to assess the feasibility of predicting 6‐month efficacy from short‐term data. A rheumatoid arthritis (RA) database was constructed from 68 reported trials. We focused on the relationship between 3‐ and 6‐month ACR50 treatment effects and developed a generalized nonlinear model to quantify the relationship and test the impact of covariates. The ΔACR50 at 6 months strongly correlated with that at 3 months, moderately correlated with that at 2 months, and only weakly correlated with results obtained at <2 months. A scaling factor that reflected the ratio of 6‐ to 3‐month treatment effects was estimated to be 0.997, suggesting that the treatment effects at 3 months are approaching a “plateau.” Drug classes, baseline Disease Activity Score in 28 Joints, and the magnitude of control arm response did not show significant impacts on the scaling factor. This work quantitatively supports the empirical clinical development paradigm of using 3‐month efficacy data to predict long‐term efficacy and to inform the probability of clinical success based on early efficacy readout. PMID:26517752

  18. Feasibility of resistance training in adult McArdle patients: clinical outcomes and muscle strength and mass benefits

    PubMed Central

    Santalla, Alfredo; Munguía-Izquierdo, Diego; Brea-Alejo, Lidia; Pagola-Aldazábal, Itziar; Díez-Bermejo, Jorge; Fleck, Steven J.; Ara, Ignacio; Lucia, Alejandro

    2014-01-01

    We analyzed the effects of a 4-month resistance (weight lifting) training program followed by a 2-month detraining period in 7 adult McArdle patients (5 female) on: muscle mass (assessed by DXA), strength, serum creatine kinase (CK) activity and clinical severity. Adherence to training was ≥84% in all patients and no major contraindication or side effect was noted during the training or strength assessment sessions. The training program had a significant impact on total and lower extremities’ lean mass (P < 0.05 for the time effect), with mean values increasing with training by +855 g (95% confidence interval (CI): 30, 1679) and +547 g (95%CI: 116, 978), respectively, and significantly decreasing with detraining. Body fat showed no significant changes over the study period. Bench press and half-squat performance, expressed as the highest value of average muscle power (W) or force (N) in the concentric-repetition phase of both tests showed a consistent increase over the 4-month training period, and decreased with detraining. Yet muscle strength and power detraining values were significantly higher than pre-training values, indicating that a training effect was still present after detraining. Importantly, all the participants, with no exception, showed a clear gain in muscle strength after the 4-month training period, e.g., bench press: +52 W (95% CI: 13, 91); half-squat: +173 W (95% CI: 96, 251). No significant time effect (P > 0.05) was noted for baseline or post strength assessment values of serum CK activity, which remained essentially within the range reported in our laboratory for McArdle patients. All the patients changed to a lower severity class with training, such that none of them were in the highest disease severity class (3) after the intervention and, as such, they did not have fixed muscle weakness after training. Clinical improvements were retained, in all but one patient, after detraining, such that after detraining all patients were classed as

  19. Feasibility of resistance training in adult McArdle patients: clinical outcomes and muscle strength and mass benefits.

    PubMed

    Santalla, Alfredo; Munguía-Izquierdo, Diego; Brea-Alejo, Lidia; Pagola-Aldazábal, Itziar; Díez-Bermejo, Jorge; Fleck, Steven J; Ara, Ignacio; Lucia, Alejandro

    2014-01-01

    We analyzed the effects of a 4-month resistance (weight lifting) training program followed by a 2-month detraining period in 7 adult McArdle patients (5 female) on: muscle mass (assessed by DXA), strength, serum creatine kinase (CK) activity and clinical severity. Adherence to training was ≥84% in all patients and no major contraindication or side effect was noted during the training or strength assessment sessions. The training program had a significant impact on total and lower extremities' lean mass (P < 0.05 for the time effect), with mean values increasing with training by +855 g (95% confidence interval (CI): 30, 1679) and +547 g (95%CI: 116, 978), respectively, and significantly decreasing with detraining. Body fat showed no significant changes over the study period. Bench press and half-squat performance, expressed as the highest value of average muscle power (W) or force (N) in the concentric-repetition phase of both tests showed a consistent increase over the 4-month training period, and decreased with detraining. Yet muscle strength and power detraining values were significantly higher than pre-training values, indicating that a training effect was still present after detraining. Importantly, all the participants, with no exception, showed a clear gain in muscle strength after the 4-month training period, e.g., bench press: +52 W (95% CI: 13, 91); half-squat: +173 W (95% CI: 96, 251). No significant time effect (P > 0.05) was noted for baseline or post strength assessment values of serum CK activity, which remained essentially within the range reported in our laboratory for McArdle patients. All the patients changed to a lower severity class with training, such that none of them were in the highest disease severity class (3) after the intervention and, as such, they did not have fixed muscle weakness after training. Clinical improvements were retained, in all but one patient, after detraining, such that after detraining all patients were classed as

  20. Personalized Kampo Medicine Facilitated Both Cytotoxic T Lymphocyte Response and Clinical Benefits Induced by Personalized Peptide Vaccination for Advanced Esophageal Cancer

    PubMed Central

    Yutani, Shigeru; Shichijo, Shigeki; Sakamoto, Shinjiro; Naito, Masayasu; Okuda, Koji; Morita, Michi; Yamaguchi, Rin; Itoh, Kyogo

    2016-01-01

    We retrospectively evaluated if personalized Kampo medicine (PKM) could facilitate CTL responses and clinical benefits induced by personalized peptide vaccination (PPV), in which HLA-matched vaccines were selected and administered based on the preexisting host immunity, for advanced esophageal cancer (aEC) patients. Among 34 aEC patients entered in the clinical study, 23 patients received PKM and PPV without (n = 12) or with chemotherapy (n = 11), while the remaining 11 patients did not receive PKM but received PPV without (n = 6) or with chemotherapy (n = 5), respectively. Incidence of adverse events was significantly lower or higher in PKM and PPV arm (n = 23) or PPV and chemotherapy arm (n = 16) as compared to that of the counter arm (n = 11 or 18), respectively. Postvaccination PBMCs from the patients undergoing PKM and PPV showed significantly higher CTL responses as compared to the counter arm. The median progression-free survival (PFS) or median survival time (MST) of 34 patients was 2.9 or 7.6 months, respectively. The combination therapy in PPV and PKM arm, but not that in PPV and chemotherapy arm, significantly (P = 0.02) prolonged MST. These results could warrant a next step of prospective clinical study of PKM and PPV for aEC patients. PMID:27703488

  1. Effects of Achieving Target Measures in Rheumatoid Arthritis on Functional Status, Quality of Life, and Resource Utilization: Analysis of Clinical Practice Data

    PubMed Central

    Joo, Seongjung; Kawabata, Hugh; Al, Maiwenn J.; Allison, Paul D.; Rutten‐van Mölken, Maureen P. M. H.; Frits, Michelle L.; Iannaccone, Christine K.; Shadick, Nancy A.; Weinblatt, Michael E.

    2016-01-01

    Objective To evaluate associations between achieving guideline‐recommended targets of disease activity, defined by the Disease Activity Score in 28 joints using C‐reactive protein level (DAS28‐CRP) <2.6, the Simplified Disease Activity Index (SDAI) ≤3.3, or the Clinical Disease Activity Index (CDAI) ≤2.8, and other health outcomes in a longitudinal observational study. Methods Other defined thresholds included low disease activity (LDA), moderate (MDA), or severe disease activity (SDA). To control for intraclass correlation and estimate effects of independent variables on outcomes of the modified Health Assessment Questionnaire (M‐HAQ), the EuroQol 5‐domain (EQ‐5D; a quality‐of‐life measure), hospitalization, and durable medical equipment (DME) use, we employed mixed models for continuous outcomes and generalized estimating equations for binary outcomes. Results Among 1,297 subjects, achievement (versus nonachievement) of recommended disease targets was associated with enhanced physical functioning and lower health resource utilization. After controlling for baseline covariates, achievement of disease targets (versus LDA) was associated with significantly enhanced physical functioning based on SDAI ≤3.3 (ΔM‐HAQ −0.047; P = 0.0100) and CDAI ≤2.8 (−0.073; P = 0.0003) but not DAS28‐CRP <2.6 (−0.022; P = 0.1735). Target attainment was associated with significantly improved EQ‐5D (0.022–0.096; P < 0.0030 versus LDA, MDA, or SDA). Patients achieving guideline‐recommended disease targets were 36–45% less likely to be hospitalized (P < 0.0500) and 23–45% less likely to utilize DME (P < 0.0100). Conclusion Attaining recommended target disease‐activity measures was associated with enhanced physical functioning and health‐related quality of life. Some health outcomes were similar in subjects attaining guideline targets versus LDA. Achieving LDA is a worthy clinical objective in some patients. PMID:26238974

  2. A randomised clinical study to measure the anti-erosion benefits of a stannous-containing sodium fluoride dentifrice

    PubMed Central

    West, Nicola; Seong, Joon; Macdonald, Emma; He, Tao; Barker, Matthew; Hooper, Susan

    2015-01-01

    Background: To compare the enamel protection efficacy of stannous-containing sodium fluoride and sodium monofluorophosphate (MFP)/triclosan dentifrices marketed in India in an in situ erosion model with acidic challenge. Materials and Methods: This randomised and controlled, in situ, supervised, double-blind clinical trial employed a two-treatment, four-period crossover design, wherein subjects wore an appliance fitted with human enamel samples 6 h/day during each 10 day treatment period and swished twice daily with their assigned dentifrice slurry: Oral-B® Pro-Health (maximum 1,000 ppm F as sodium fluoride with stannous chloride) or Colgate® Strong Teeth with Cavity Protection (maximum 1,000 F as sodium MFP and triclosan). Subjects swished with 250 ml of orange juice over a 10 min period after each treatment and twice daily for the acidic erosive challenge. Enamel samples were measured for tooth surface loss using contact profilometry at baseline and day 10. Results: A total of 34 subjects were randomised to treatment; 32 subjects completed the final visit. Baseline profilometry measurements of the specimen surfaces were near zero within ± 0.3 μm, and no statistically significant difference (P > 0.48) on average was observed between the two test dentifrices. At day 10, the stannous-containing dentifrice demonstrated 88% less erosion (P < 0.0001) relative to the MFP/triclosan dentifrice. Estimated medians (95% confidence intervals) were 0.21 μm (0.17, 0.25) for the stannous-containing dentifrice versus 1.66 μm (1.39, 1.99) for the MFP/triclosan dentifrice. Both dentifrices were well-tolerated. Conclusions: Compared with MFP/triclosan toothpaste, a stabilised stannous-containing sodium fluoride dentifrice gave statistically significantly greater protection against tooth enamel surface loss in situ following repeated acid erosive challenge. PMID:26015669

  3. Decreased Sperm Motility Retarded ICSI Fertilization Rate in Severe Oligozoospermia but Good-Quality Embryo Transfer Had Achieved the Prospective Clinical Outcomes

    PubMed Central

    Zheng, Jufeng; Lu, Yongning; Qu, Xianqin; Wang, Peng; Zhao, Luiwen; Gao, Minzhi; Shi, Huijuan; Jin, Xingliang

    2016-01-01

    . Overall rates in all groups were 41.26% clinical pregnancy, 25.74% implantation and 36.32% live birth, which gave live birth to 252 girls and 252 boys. Conclusions The reduction of motile spermatozoa in severe oligozoospermia decreased the rates of fertilization and good-quality embryo. Obtaining and transfer of good-quality embryos was the good prognostic to achieve prospective clinical outcomes regardless of the severity of oligozoospermia. PMID:27661081

  4. Combining moderators to identify clinical profiles of patients who will, and will not, benefit from aripiprazole augmentation for treatment resistant late-life major depressive disorder.

    PubMed

    Smagula, Stephen F; Wallace, Meredith L; Anderson, Stewart J; Karp, Jordan F; Lenze, Eric J; Mulsant, Benoit H; Butters, Meryl A; Blumberger, Daniel M; Diniz, Breno S; Lotrich, Francis E; Dew, Mary Amanda; Reynolds, Charles F

    2016-10-01

    Personalizing treatment for late-life depression requires identifying and integrating information from multiple factors that influence treatment efficacy (moderators). We performed exploratory moderator analyses using data from a multi-site, randomized, placebo-controlled, double-blind trial of aripiprazole augmentation. Patients (n = 159) aged ≥60 years had major depressive disorder that failed to remit with venlafaxine monotherapy. We examined effect sizes of 39 potential moderators of aripiprazole (vs. placebo) augmentation efficacy using the outcome of percentage reduction in depressive symptom after 12 weeks. We then incorporated information from the individually relevant variables in combined moderators. A larger aripiprazole treatment effect was related to: white race, better physical function, better performance on Trail-Making, attention, immediate, and delayed memory tests, greater psychomotor agitation and suicidality symptoms, and a history of adequate antidepressant pharmacotherapy. A smaller aripiprazole treatment effect was observed in patients with: more pain and more work/activity impairment and libido symptoms. Combining information from race and Trail-Making test performance (base combined moderator (Mb*)) produced a larger effect size (Spearman effect size = 0.29 (95% confidence interval (CI): 0.15, 0.42)) than any individual moderator. Adding other individually relevant moderators in the full combined moderator (Mf*) further improved effect size (Spearman effect size = 0.39 (95% CI: 0.25, 0.52)) and identified a sub-group benefiting more from placebo plus continuation venlafaxine monotherapy than adjunctive aripiprazole. Combining moderators can help clinicians personalize depression treatment. We found the majority of our patients benefited from adjunctive aripiprazole, but a smaller subgroup that is identifiable using clinical measures appeared to benefit more from continuation venlafaxine plus placebo. PMID:27438687

  5. Impact on Life Expectancy of Withdrawing Thiopurines in Patients with Crohn’s Disease in Sustained Clinical Remission: A Lifetime Risk-Benefit Analysis

    PubMed Central

    Kirchgesner, Julien; Beaugerie, Laurent; Carrat, Fabrice; Sokol, Harry; Cosnes, Jacques; Schwarzinger, Michaël

    2016-01-01

    Objective Long-term treatment with thiopurines is associated with a decreased risk of Crohn’s disease (CD) flare but an increased risk of various cancers depending on gender, age, and presence of extensive colitis. We evaluated risks and benefits of withdrawing thiopurines in patients with CD in prolonged remission. Methods We developed a Markov model assessing risks and benefits of withdrawing thiopurines compared to continuing thiopurines in a lifetime horizon. The model was stratified by age (35 and 65 years old at thiopurine withdrawal), gender and presence of extensive colitis. Parameter estimates were taken from French cohorts and hospital databases, cancer and death national registries and published literature. Life expectancy, rates of relapse, serious adverse events, and causes-of-death were evaluated. Results In patients without extensive colitis, continuing thiopurines increased life expectancy up to 0.03 years for 35 year-old men and women but decreased life expectancy down to 0.07 years for 65 year-old men and women. Withdrawal strategy became the preferred strategy at 40.6 years for men, and 45.7 years for women without extensive colitis. In patients with extensive colitis, continuation strategy was the preferred strategy regardless of age. Risk-benefit analysis was not modified by duration of CD activity. Conclusions Factors determining life expectancy associated with withdrawal or continuation of thiopurines in patients with CD and in sustained clinical remission vary substantially according to gender, age and presence of extensive colitis. Individual decisions to continue or withdraw thiopurines in patients with CD in sustained remission should take into account these parameters. PMID:27271176

  6. Can repeat injection provide clinical benefit in patients with cervical disc herniation and stenosis when the first epidural injection results only in partial response?

    PubMed

    Lee, Jung Hwan; Lee, Sang-Ho

    2016-07-01

    Epidural steroid injection (ESI) is known to be an effective treatment for neck or radicular pain due to herniated intervertebral disc (HIVD) and spinal stenosis (SS). Although repeat ESI has generally been indicated to provide more pain relief in partial responders after single ESI, there has been little evidence supporting the usefulness of this procedure. The purpose of this study, therefore, was to determine whether repeat ESI at a prescribed interval of 2 to 3 weeks after the first injection would provide greater clinical benefit in patients with partial pain reduction than intermittent ESI performed only when pain was aggravated. One hundred eighty-four patients who underwent transforaminal ESI (TFESI) for treatment of axial neck and radicular arm pain due to HIVD or SS and could be followed up for 1 year were enrolled. We divided the patients into 2 groups. Group A (N = 108) comprised partial responders (numeric rating scale (NRS) ≥ 3 after the first injection) who underwent repeat injection at a prescribed interval of 2 to 3 weeks after the first injection. Group B (N = 76) comprised partial responders who did not receive repeat injection at the prescribed interval, but received intermittent injections only for aggravation of pain. Various clinical data were assessed, including total number of injections during 1 year, NRS duration of <3 during 1 year (NRS < 3 duration), and time interval until pain was increased to require additional injections after repeat injection in Group A, or after first injection in Group B (time to reinjection). Groups A and B were compared in terms of total population, HIVD, and SS. In the whole population, HIVD subgroup, and SS subgroup, patients in Group A required significantly fewer injections to obtain satisfactory pain relief during the 1-year follow-up period. Group A showed a significantly longer time to reinjection and longer NRS < 3 than Group B did. Repeat TFESI conducted at 2- to 3-week intervals

  7. Benefits of a comprehensive quality program for cryopreserved PBMC covering 28 clinical trials sites utilizing an integrated, analytical web-based portal

    PubMed Central

    Ducar, Constance; Smith, Donna; Pinzon, Cris; Stirewalt, Michael; Cooper, Cristine; McElrath, M. Juliana; Hural, John

    2014-01-01

    assays (mean, 91.46% ±4.5%), and 96.2% had acceptable recoveries (50%–130%) with a mean of recovery of 85.8% ±19.12% of the originally cryopreserved cells. EQC testing revealed that since August 2009, failed recoveries dropped from 4.1% to 1.6% and failed viabilities dropped from 1.0% to 0.3%. The HVTN PBMC quality program provides for laboratory assessment, training and tools for identifying problems, implementing corrective action and monitoring for improvements. These data support the benefits of implementing a comprehensive, web-based PBMC quality program for large clinical trials networks. PMID:24709391

  8. KDR Amplification Is Associated with VEGF-Induced Activation of the mTOR and Invasion Pathways but does not Predict Clinical Benefit to the VEGFR TKI Vandetanib

    PubMed Central

    Nilsson, Monique B.; Giri, Uma; Gudikote, Jayanthi; Tang, Ximing; Lu, Wei; Tran, Hai; Fan, Youhong; Koo, Andrew; Diao, Lixia; Tong, Pan; Wang, Jing; Herbst, Roy; Johnson, Bruce E.; Ryan, Andy; Webster, Alan; Rowe, Philip; Wistuba, Ignacio I.; Heymach, John V.

    2016-01-01

    Purpose VEGF pathway inhibitors have been investigated as therapeutic agents in the treatment of non–small cell lung cancer (NSCLC) because of its central role in angiogenesis. These agents have improved survival in patients with advanced NSCLC, but the effects have been modest. Although VEGFR2/KDR is typically localized to the vasculature, amplification of KDR has reported to occur in 9% to 30% of the DNA from different lung cancers. We investigated the signaling pathways activated downstream of KDR and whether KDR amplification is associated with benefit in patients with NSCLC treated with the VEGFR inhibitor vandetanib. Methods NSCLC cell lines with or without KDR amplification were studied for the effects of VEGFR tyrosine kinase inhibitors (TKI) on cell viability and migration. Archival tumor samples collected from patients with platinum-refractory NSCLC in the phase III ZODIAC study of vandetanib plus docetaxel or placebo plus docetaxel (N = 294) were screened for KDR amplification by FISH. Results KDR amplification was associated with VEGF-induced activation of mTOR, p38, and invasiveness in NSCLC cell lines. However, VEGFR TKIs did not inhibit proliferation of NSCLC cell lines with KDR amplification. VEGFR inhibition decreased cell motility as well as expression of HIF1α in KDR-amplified NSCLC cells. In the ZODIAC study, KDR amplification was observed in 15% of patients and was not associated with improved progression-free survival, overall survival, or objective response rate for the vandetanib arm. Conclusions Preclinical studies suggest KDR activates invasion but not survival pathways in KDR-amplified NSCLC models. Patients with NSCLC whose tumor had KDR amplification were not associated with clinical benefit for vandetanib in combination with docetaxel. PMID:26578684

  9. Effectiveness of Music Education for the Improvement of Reading Skills and Academic Achievement in Young Poor Readers: A Pragmatic Cluster-Randomized, Controlled Clinical Trial

    PubMed Central

    Cogo-Moreira, Hugo; de Ávila, Clara Regina Brandão; Ploubidis, George B.; Mari, Jair de Jesus

    2013-01-01

    Introduction Difficulties in word-level reading skills are prevalent in Brazilian schools and may deter children from gaining the knowledge obtained through reading and academic achievement. Music education has emerged as a potential method to improve reading skills because due to a common neurobiological substratum. Objective To evaluate the effectiveness of music education for the improvement of reading skills and academic achievement among children (eight to 10 years of age) with reading difficulties. Method 235 children with reading difficulties in 10 schools participated in a five-month, randomized clinical trial in cluster (RCT) in an impoverished zone within the city of São Paulo to test the effects of music education intervention while assessing reading skills and academic achievement during the school year. Five schools were chosen randomly to incorporate music classes (n = 114), and five served as controls (n = 121). Two different methods of analysis were used to evaluate the effectiveness of the intervention: The standard method was intention-to-treat (ITT), and the other was the Complier Average Causal Effect (CACE) estimation method, which took compliance status into account. Results The ITT analyses were not very promising; only one marginal effect existed for the rate of correct real words read per minute. Indeed, considering ITT, improvements were observed in the secondary outcomes (slope of Portuguese = 0.21 [p<0.001] and slope of math = 0.25 [p<0.001]). As for CACE estimation (i.e., complier children versus non-complier children), more promising effects were observed in terms of the rate of correct words read per minute [β = 13.98, p<0.001] and phonological awareness [β = 19.72, p<0.001] as well as secondary outcomes (academic achievement in Portuguese [β = 0.77, p<0.0001] and math [β = 0.49, p<0.001] throughout the school year). Conclusion The results may be seen as promising, but they are not, in themselves

  10. Long-range safety and protective benefits of angiotensin-converting enzyme inhibitors for hypertension. Do we need more clinical trials?

    PubMed Central

    Sambhi, M P; Gavras, H; Robertson, J I; Smith, W M

    1993-01-01

    Inhibition of the renin-angiotensin system is being applied with considerable success to the treatment of hypertension and heart failure. Angiotensin-converting enzyme (ACE) inhibitors are the only currently available agents that can achieve this objective. In general, the major therapeutic effects of these agents in the treatment of mild to moderate hypertension or of heart failure are exerted on the vascular tissue through inhibition of the renin-angiotensin system and, secondarily, of the sympathetic nervous system. When cardiovascular functional reserve is diminished and autoregulation of regional and systemic blood flow is strained, however, ACE inhibitors may affect other organ functions (heart, kidneys, and possibly brain), hormones other than the renin system, and local tissue humoral systems. The interrelations between the renin-angiotensin system and several other vasoactive systems--including circulating and locally generated tissue hormones and centrally acting neurohormonal factors--are complex and unclear. A better understanding of these mechanisms and interrelations would allow for a more rational therapeutic use of these agents. Unknown also are the clinical effects of prolonged ACE inhibition. Whether the use of ACE inhibitors can provide primary cardiorenal protection requires proof through definitive clinical trials. Images PMID:8460511

  11. Economic and clinical benefits of endometrial radiofrequency ablation compared with other ablation techniques in women with menorrhagia: a retrospective analysis with German health claims data

    PubMed Central

    Bischoff-Everding, Christoph; Soeder, Ruediger; Neukirch, Benno

    2016-01-01

    Objective To evaluate the economic and clinical benefits of endometrial radiofrequency ablation (RFA) compared with other ablation techniques for the treatment of menorrhagia. Methods Using German health claims data, women meeting defined inclusion criteria for the intervention group (RFA) were selected. A comparable control group (other endometrial ablations) was established using propensity score matching. These two groups were compared during the quarter of treatment (QoT) and a follow-up of 2 years for the following outcomes: costs during QoT and during follow-up, repeated menorrhagia diagnoses during follow-up and necessary retreatments during follow-up. Results After performing propensity score matching, 50 cases could be allocated to the intervention group, while 38 were identified as control cases. Patients in the RFA group had 5% fewer repeat menorrhagia diagnoses (40% vs 45%; not significant) and 5% fewer treatments associated with recurrent menorrhagia (6% vs 11%; not significant) than cases in the control group. During the QoT, the RFA group incurred €578 additional costs (€2,068 vs €1,490; ns). However, during follow-up, the control group incurred €1,254 additional costs (€4,561 vs €5,815; ns), with medication, outpatient physician consultations, and hospitals costs being the main cost drivers. However, none of the results were statistically significant. Conclusion Although RFA was more cost-intensive in the QoT compared with other endometrial ablation techniques, an average total savings of €676 was generated during the follow-up period. While having evidence that RFA is clinically equivalent to other endometrial ablation procedures, we generated indications that RFA is non-inferior and favorable with regard to economic outcomes. PMID:26848277

  12. Histone deacetylase inhibitor romidepsin induces HIV expression in CD4 T cells from patients on suppressive antiretroviral therapy at concentrations achieved by clinical dosing.

    PubMed

    Wei, Datsen George; Chiang, Vicki; Fyne, Elizabeth; Balakrishnan, Mini; Barnes, Tiffany; Graupe, Michael; Hesselgesser, Joseph; Irrinki, Alivelu; Murry, Jeffrey P; Stepan, George; Stray, Kirsten M; Tsai, Angela; Yu, Helen; Spindler, Jonathan; Kearney, Mary; Spina, Celsa A; McMahon, Deborah; Lalezari, Jacob; Sloan, Derek; Mellors, John; Geleziunas, Romas; Cihlar, Tomas

    2014-04-01

    Persistent latent reservoir of replication-competent proviruses in memory CD4 T cells is a major obstacle to curing HIV infection. Pharmacological activation of HIV expression in latently infected cells is being explored as one of the strategies to deplete the latent HIV reservoir. In this study, we characterized the ability of romidepsin (RMD), a histone deacetylase inhibitor approved for the treatment of T-cell lymphomas, to activate the expression of latent HIV. In an in vitro T-cell model of HIV latency, RMD was the most potent inducer of HIV (EC50 = 4.5 nM) compared with vorinostat (VOR; EC50 = 3,950 nM) and other histone deacetylase (HDAC) inhibitors in clinical development including panobinostat (PNB; EC50 = 10 nM). The HIV induction potencies of RMD, VOR, and PNB paralleled their inhibitory activities against multiple human HDAC isoenzymes. In both resting and memory CD4 T cells isolated from HIV-infected patients on suppressive combination antiretroviral therapy (cART), a 4-hour exposure to 40 nM RMD induced a mean 6-fold increase in intracellular HIV RNA levels, whereas a 24-hour treatment with 1 µM VOR resulted in 2- to 3-fold increases. RMD-induced intracellular HIV RNA expression persisted for 48 hours and correlated with sustained inhibition of cell-associated HDAC activity. By comparison, the induction of HIV RNA by VOR and PNB was transient and diminished after 24 hours. RMD also increased levels of extracellular HIV RNA and virions from both memory and resting CD4 T-cell cultures. The activation of HIV expression was observed at RMD concentrations below the drug plasma levels achieved by doses used in patients treated for T-cell lymphomas. In conclusion, RMD induces HIV expression ex vivo at concentrations that can be achieved clinically, indicating that the drug may reactivate latent HIV in patients on suppressive cART.

  13. A clinical prognostic scoring system for resectable gastric cancer to predict survival and benefit from paclitaxel- or oxaliplatin-based adjuvant chemotherapy

    PubMed Central

    Qian, Jing; Qian, Yingying; Wang, Jian; Gu, Bing; Pei, Dong; He, Shaohua; Zhu, Fang; Røe, Oluf Dimitri; Xu, Jin; Liu, Lianke; Gu, Yanhong; Guo, Renhua; Yin, Yongmei; Shu, Yongqian; Chen, Xiaofeng

    2016-01-01

    Background Gastrectomy with D2 lymphadenectomy is a standard procedure of curative resection for gastric cancer (GC). The aim of this study was to develop a simple and reliable prognostic scoring system for GC treated with D2 gastrectomy combined with adjuvant chemotherapy. Methods A prognostic scoring system was established based on clinical and laboratory data from 579 patients with localized GC without distant metastasis treated with D2 gastrectomy and adjuvant chemotherapy. Results From the multivariate model for overall survival (OS), five factors were selected for the scoring system: ≥50% metastatic lymph node rate, positive lymphovascular invasion, pathologic TNM Stage II or III, ≥5 ng/mL preoperative carcinoembryonic antigen level, and <110 g/L preoperative hemoglobin. Two models were derived using different methods. Model A identified low- and high-risk patients for OS (P<0.001), while Model B differentiated low-, intermediate-, and high-risk patients for OS (P<0.001). Stage III patients in the low-risk group had higher survival probabilities than Stage II patients. Both Model A (area under the curve [AUC]: 0.74, 95% confidence interval [CI]: 0.69–0.78) and Model B (AUC: 0.79, 95% CI: 0.72–0.83) were better predictors compared with the pathologic TNM classification (AUC: 0.62, 95% CI: 0.59–0.71, P<0.001). Adjuvant paclitaxel- or oxaliplatin-based or triple chemotherapy showed significantly better outcomes in patients classified as high risk, but not in those with low and intermediate risk. Conclusion A clinical three-tier prognostic risk scoring system was established to predict OS of GC treated with D2 gastrectomy and adjuvant chemotherapy. The potential advantage of this scoring system is that it can identify high-risk patients in Stage II or III who may benefit from paclitaxel- or oxaliplatin-based regimens. Prospective studies are needed to confirm these results before they are applied clinically. PMID:26966350

  14. Multiple Benefits.

    ERIC Educational Resources Information Center

    Kreider, Beth

    1997-01-01

    Discusses the benefits of dome architecture for a community's middle- and high-school multi-purpose facility. The dome construction is revealed as being cost effective in construction and in maintenance and energy costs. (GR)

  15. Are there long-term benefits of experiential, interprofessional education for non-specialists on clinical behaviours and outcomes in diabetes care? A cohort study

    PubMed Central

    Ching, Daniel; Forte, Denise; Aitchison, Elizabeth; Earle, Kenneth

    2016-01-01

    Objectives Our aim was to assess the impact of an educational initiative for non-specialist, healthcare professionals in the community on the process and quality measures of diabetes care delivered, and changes in their learning experiences and clinical management behaviour in the short and long term. Setting Single locality of 26 primary care practices associated with one secondary centre. Participants General practitioners and practice nurses managing 4167 patients with diabetes. Intervention A rolling 10-week, experiential, interprofessional education programme delivered to 57 practitioners and observations in practice. Primary and secondary outcome measures Primary outcomes were changes in the proportion of patients receiving foot care, urine albumin:creatinine ratio assessments and achieving National Quality Outcome Framework targets for blood pressure (<145/80 mm Hg), glycated haemoglobin (HbA1c; >86 mmol/mol (10%) and <57.4 mmol/mol (7.4%)) and total cholesterol (<5 mmol/L) thresholds. Secondary outcomes were evidence of sustained learning and changes in the number of patients referred to secondary care. Results Evaluation of care processes and quality outcomes took place 15 months after the programme was initiated. The proportion of patients with a HbA1c of <57.4 mmol/mol (7.4%) and >85 mmol/mol (10%) was significantly higher (44% vs 53% p=0.0001) and lower (12.5% vs 10%; p=0.002) respectively. There was an increase in the proportion (95% CI) of patients receiving foot care reviews (+26.0% (24.0% to 28.1%)), microalbuminuria screening (+29.8% (27.7% to 31.9%)) and who achieved targets for blood pressure (+9.6% (7.5% to 11.6%)) and total cholesterol (+14.4% (12.3% to 16.5%); p<0.001). 241 fewer patients were referred to secondary care. Increases in the healthcare professional's confidence and collaborative clinical behaviour were evident 3 years after completing the programme. Conclusions An experiential, interprofessional intervention can

  16. Benefits of antihypertensive medications for anthracycline- and trastuzumab-induced cardiotoxicity in patients with breast cancer: Insights from recent clinical trials

    PubMed Central

    Rygiel, Katarzyna

    2016-01-01

    Advances in oncologic therapies have allowed many patients with breast cancer to achieve better outcomes and longer survival. However, this progress has been tempered by cardiotoxicity, associated with anticancer therapies, ranging from subclinical abnormalities to irreversible life-threatening complications, such as congestive heart failure or cardiomyopathy. In particular, exposure to chemotherapy (CHT), including anthracyclines and trastuzumab, can lead to cardiac dysfunction with short- or long-term consequences, among patients with breast cancer. The aim of this study is to highlight the potential role of commonly used cardiac medications in the prevention of anthracycline- and trastuzumab-mediated cardiotoxicity, in women with breast cancer, based on evidence from recent clinical trials. This overview is focused on the use of antihypertensive medications, such as angiotensin-converting enzyme inhibitors and angiotensin receptor blockers, outlining their cardioprotective effects in this patient population. In addition, the importance of biomarkers and modern imaging tests, as potential tools for detection and monitoring of cardiac dysfunction, induced by CHT, as well as some practical preventive and therapeutic strategies for cardio-oncology treatment teams, involved in the management of a growing number of women with breast cancer have been outlined. The content of this overview is based on a literature search of PubMed, within the last 5 years, mostly in relevance to the human epidermal growth factor receptor 2-positive patients with breast cancer, treated with anthracycline or trastuzumab therapy (in addition to surgery and/or radiation therapy [RT] regimen). PMID:27721532

  17. Medicaid Benefits

    MedlinePlus

    ... Topic Eligibility Benefits Cost Sharing Waivers Long Term Services and Supports Delivery Systems Quality of Care Data and Systems Enrollment Strategies Access to Care Program Integrity Financing and ... type, amount, duration, and scope of services within broad federal guidelines. States are required to ...

  18. Benefits of switching from latanoprost to preservative-free tafluprost eye drops: a meta-analysis of two Phase IIIb clinical trials

    PubMed Central

    Uusitalo, Hannu; Egorov, Evgeniy; Kaarniranta, Kai; Astakhov, Yuri; Ropo, Auli

    2016-01-01

    Introduction Glaucoma patients frequently exhibit ocular surface side effects during treatment with prostaglandin eye drops. The present work investigated whether glaucoma patients suffering from signs and symptoms of ocular surface disease while using preserved latanoprost eye drops benefited from switching to preservative-free tafluprost eye drops. Patients and methods The analysis was based on 339 glaucoma patients enrolled in two Phase IIIb trials. The patients were required to have two symptoms, or one sign and one symptom of ocular surface disease at baseline, and at least 6 months preceding treatment with latanoprost eye drops preserved with benzalkonium chloride. All eligible patients were switched from latanoprost to preservative-free tafluprost for a total of 12 weeks. Ocular symptoms and ocular signs were evaluated at baseline and at 2 weeks, 6 weeks, and 12 weeks after commencing treatment with tafluprost. Intraocular pressure (IOP), drop discomfort, and treatment preference were evaluated to investigate the clinical efficacy and patient-related outcomes. Results After 12 weeks of treatment with preservative-free tafluprost, the incidences of irritation/burning/stinging, foreign body sensation, tearing, itching, and dry eye sensation had diminished to one-third of those reported for preserved latanoprost at baseline. The incidences of blepharitis and corneal/conjunctival fluorescein staining had in turn decreased to one-half of those reported for preserved latanoprost. Severity of conjunctival hyperemia was halved during treatment with preservative-free tafluprost, and there was significant improvement in tear break-up time and tear production. A further reduction in IOP (~1 mmHg) was seen with preservative-free tafluprost compared with preserved latanoprost. Drop discomfort was alleviated during preservative-free tafluprost treatment, and an outstanding majority of patients (72%) preferred preservative-free tafluprost over preserved latanoprost

  19. SU-E-T-361: Clinical Benefit of Automatic Beam Gating Mixed with Breath Hold in Radiation Therapy of Left Breast

    SciTech Connect

    Wu, J; Hill, G; Spiegel, J; Ye, J; Mehta, V

    2014-06-01

    Purpose: To investigate the clinical and dosimetric benefits of automatic gating of left breast mixed with breath-hold technique. Methods: Two Active Breathing Control systems, ABC2.0 and ABC3.0, were used during simulation and treatment delivery. The two systems are different such that ABC2.0 is a breath-hold system without beam control capability, while ABC3.0 has capability in both breath-hold and beam gating. At simulation, each patient was scanned twice: one with free breathing (FB) and one with breath hold through ABC. Treatment plan was generated on the CT with ABC. The same plan was also recalculated on the CT with FB. These two plans were compared to assess plan quality. For treatments with ABC2.0, beams with MU > 55 were manually split into multiple subfields. All subfields were identical and shared the total MU. For treatment with ABC3.0, beam splitting was unnecessary. Instead, treatment was delivered in gating mode mixed with breath-hold technique. Treatment delivery efficiency using the two systems was compared. Results: The prescribed dose was 50.4Gy at 1.8Gy/fraction. The maximum heart dose averaged over 10 patients was 46.0±2.5Gy and 24.5±12.2Gy for treatments with FB and with ABC respectively. The corresponding heart V10 was 13.2±3.6% and 1.0±1.6% respectively. The averaged MUs were 99.8±7.5 for LMT, 99.2±9.4 for LLT. For treatment with ABC2.0, normally the original beam was split into 2 subfields. The averaged total time to delivery all beams was 4.3±0.4min for treatments with ABC2.0 and 3.3±0.6min for treatments with ABC3.0 in gating mode. Conclusion: Treatment with ABC tremendously reduced heart dose. Compared to treatments with ABC2.0, gating with ABC3.0 reduced the total treatment time by 23%. Use of ABC3.0 improved the delivery efficiency, and eliminated the possibility of mistreatments. The latter may happen with ABC2.0 where beam is not terminated when breath signal falls outside of the treatment window.

  20. Benefits of infant massage.

    PubMed

    Day, Jane

    2014-05-01

    After spending three months as a clinical midwifery tutor at a remote hospital in Zambia, where I helped to train student midwives and other students, my interest in infant massage was ignited, having witnessed the benefits of massage to both mother and baby. Once back in the UK, I trained and qualified as a massage instructor with an international infant massage training organisation, which has led me to work extensively with parents and babies, offering one-to-one and group courses. It has been a privilege to be able to teach parents the valuable skill of infant massage, and consequently pass on the benefits both physiological and psychosocial. PMID:24873112

  1. Technology Benefits

    NASA Technical Reports Server (NTRS)

    Haller, William

    2001-01-01

    An assessment was recently performed by NASA s Inter-Center Systems Analysis Team to quantify the potential emission reduction benefits from technologies being developed under UEET. The CO2 and LTO NO, reductions were estimated for 4 vehicles: a 50-passenger regional jet, a twin-engine, long-range subsonic transport, a high-speed (Mach 2.4) civil transport and a supersonic (Mach 2) business jet. The results of the assessment confirm that the current portfolio of technologies within the UEET program provides an opportunity for substantial reductions in CO2 and NO, emissions.

  2. Relationship Between the Clinical Components of the Boder Test of Reading-Spelling Patterns and the Stanford Achievement Test: Validity of the Boder.

    ERIC Educational Resources Information Center

    Hooper, Stephen R.

    1988-01-01

    Investigated the concurrent validity of the diagnostic components of the Boder Test of Reading-Spelling Patterns with the reading and spelling measures of the Stanford Achievement Reading Test (SAT) in 87 reading-disabled elementary school students. Results indicated the relationship between the reading components of the Boder and SAT were…

  3. Achieving deeper molecular response is associated with a better clinical outcome in chronic myeloid leukemia patients on imatinib front-line therapy

    PubMed Central

    Etienne, Gabriel; Dulucq, Stéphanie; Nicolini, Franck-Emmanuel; Morisset, Stéphane; Fort, Marie-Pierre; Schmitt, Anna; Etienne, Madeleine; Hayette, Sandrine; Lippert, Eric; Bureau, Caroline; Tigaud, Isabelle; Adiko, Didier; Marit, Gérald; Reiffers, Josy; Mahon, François-Xavier

    2014-01-01

    Sustained imatinib treatment in chronic myeloid leukemia patients can result in complete molecular response allowing discontinuation without relapse. We set out to evaluate the frequency of complete molecular response in imatinib de novo chronic phase chronic myeloid leukemia patients, to identify base-line and under-treatment predictive factors of complete molecular response in patients achieving complete cytogenetic response, and to assess if complete molecular response is associated with a better outcome. A random selection of patients on front-line imatinib therapy (n=266) were considered for inclusion. Complete molecular response was confirmed and defined as MR 4.5 with undetectable BCR-ABL transcript levels. Median follow up was 4.43 years (range 0.79–10.8 years). Sixty-five patients (24%) achieved complete molecular response within a median time of 32.7 months. Absence of spleen enlargement at diagnosis, achieving complete cytogenetic response before 12 months of therapy, and major molecular response during the year following complete cytogenetic response was predictive of achieving further complete molecular response. Patients who achieved complete molecular response had better event-free and failure-free survivals than those with complete cytogenetic response irrespective of major molecular response status (95.2% vs. 64.7% vs. 27.7%, P=0.00124; 98.4% vs. 82.3% vs. 56%, P=0.0335), respectively. Overall survival was identical in the 3 groups. In addition to complete cytogenetic response and major molecular response, further deeper molecular response is associated with better event-free and failure-free survivals, and complete molecular response confers the best outcome. PMID:24362549

  4. Low high-density lipoprotein cholesterol is a residual risk factor associated with long-term clinical outcomes in diabetic patients with stable coronary artery disease who achieve optimal control of low-density lipoprotein cholesterol.

    PubMed

    Ogita, Manabu; Miyauchi, Katsumi; Miyazaki, Tadashi; Naito, Ryo; Konishi, Hirokazu; Tsuboi, Shuta; Dohi, Tomotaka; Kasai, Takatoshi; Yokoyama, Takayuki; Okazaki, Shinya; Kurata, Takeshi; Daida, Hiroyuki

    2014-01-01

    Diabetes mellitus is recognized an independent risk factor for coronary artery disease (CAD) and mortality. Clinical trials have shown that statins significantly reduce cardiovascular events in diabetic patients. However, residual cardiovascular risk persists despite the achievement of target low-density lipoprotein cholesterol (LDL-C) levels with statin. High-density lipoprotein cholesterol (HDL-C) is an established coronary risk factor that is independent of LDL-C levels. We evaluated the impact of HDL-C on long-term mortality in diabetic patients with stable CAD who achieved optimal LDL-C. We enrolled 438 consecutive diabetic patients who were scheduled for percutaneous coronary intervention between 2004 and 2007 at our institution. We identified 165 patients who achieved target LDL-C <100 mg/dl. Patients were stratified into two groups according to HDL-C levels (low HDL-C group, baseline HDL-C <40 mg/dl; high HDL-C group, ≥40 mg/dl). Major adverse cardiac events (MACE) that included all-cause death, acute coronary syndrome, and target lesion revascularization were evaluated between the two groups. The median follow-up period was 946 days. The rate of MACE was significantly higher in diabetic patients with low-HDL-C who achieved optimal LDL-C (6.9 vs 17.9 %, log-rank P = 0.030). Multivariate Cox regression analysis showed that HDL-C is significantly associated with clinical outcomes (adjusted hazard ratio for MACE 1.33, 95 % confidence interval 1.01-1.75, P = 0.042). Low HDL-C is a residual risk factor that is significantly associated with long-term clinical outcomes among diabetic patients with stable CAD who achieve optimal LDL-C levels.

  5. Benefits and Risks in Secondary Use of Digitized Clinical Data: Views of Community Members Living in a Predominantly Ethnic Minority Urban Neighborhood

    PubMed Central

    Lucero, Robert J.; Kearney, Joan; Cortes, Yamnia; Arcia, Adriana; Appelbaum, Paul; Fernández, Roberto Lewis; Luchsinger, Jose

    2015-01-01

    Background There is potential to increase the speed of scientific discovery and implement personalized health care by using digitized clinical data collected on the patient care experience. The use of these data in research raises concerns about the privacy and confidentiality of personal health information. This study explored community members’ views on the secondary use of digitized clinical data to (1) recruit participants for clinical studies; (2) recruit family members of persons with an index condition for primary studies; and (3) conduct studies of information related to stored biospecimens. Methods A qualitative descriptive design was used to examine the bioethical issues outlined from the perspective of urban-dwelling community members. Focus groups were used for data collection, and emergent content analysis was employed to organize and interpret the data. Results Thirty community members attended one of four focus groups ranging in size from 4 to 11 participants. Five critical themes emerged from the focus-group material: (1) perceived motivators for research participation; (2) objective or “real-life” barriers to research participation; (3) a psychological component of uncertainty and mistrust; (4) preferred mechanisms for recruitment and participation; and (5) cultural characteristics that can impact understanding and willingness to engage in research. Conclusions The overriding concern of community members regarding research participation and/or secondary clinical and nonclinical use of digitized information was that their involvement would be safe and the outcome would be meaningful to them and to others. According to participants, biospecimens acquired during routine clinical visits or for research are no longer possessions of the participant. Although the loss of privacy was a concern for participants, they preferred that researchers access their personal health information using a digitized clinical file rather than through a paper

  6. General Rules for the Clinical and Pathological Study of Primary Liver Cancer, Nationwide Follow-Up Survey and Clinical Practice Guidelines: The Outstanding Achievements of the Liver Cancer Study Group of Japan.

    PubMed

    Kudo, Masatoshi; Kitano, Masayuki; Sakurai, Toshiharu; Nishida, Naoshi

    2015-10-01

    This review outlines the significance of establishing general rules, a nationwide follow-up survey, and clinical practice guidelines for liver cancer in Japan. The general rules are an essential part of hepatocellular carcinoma (HCC) treatment, enabling a 'common language' to be used in daily clinical practice and for the nationwide follow-up survey. The Japanese General Rules for the Clinical and Pathological Study of Primary Liver Cancer, which provide detailed descriptions of HCC, are excellent and are unique to Japan. Items in the General Rules for the Clinical and Pathological Study of Primary Liver Cancer are used substantially in another important project, the Nationwide Follow-Up Survey of Primary Liver Cancer, which has been rigorously undertaken with great effort by the Liver Cancer Study Group of Japan biannually since 1969. Both evidence-based and consensus-based treatment algorithms for HCC are used to complement each other in clinical practice in Japan.

  7. Maximizing Effectiveness Trials in PTSD and SUD Through Secondary Analysis: Benefits and Limitations Using the National Institute on Drug Abuse Clinical Trials Network “Women and Trauma” Study as a Case Example

    PubMed Central

    Hien, Denise A.; Campbell, Aimee N.C.; Ruglass, Lesia M.; Saavedra, Lissette; Mathews, Abigail G.; Kiriakos, Grace; Morgan-Lopez, Antonio

    2015-01-01

    Recent federal legislation and a renewed focus on integrative care models underscore the need for economical, effective, and science-based behavioral health care treatment. As such, maximizing the impact and reach of treatment research is of great concern. Behavioral health issues, including the frequent co-occurrence of substance use disorders (SUD) and posttraumatic stress disorder (PTSD), are often complex, with a myriad of factors contributing to the success of interventions. Although treatment guides for comorbid SUD/PTSD exist, most patients continue to suffer symptoms following the prescribed treatment course. Further, the study of efficacious treatments has been hampered by methodological challenges (e.g., overreliance on “superiority” designs (i.e., designs structured to test whether or not one treatment statistically surpasses another in terms of effect sizes) and short term interventions). Secondary analyses of randomized controlled clinical trials offer potential benefits to enhance understanding of findings and increase the personalization of treatment. This paper offers a description of the limits of randomized controlled trials as related to SUD/PTSD populations, highlights the benefits and potential pitfalls of secondary analytic techniques, and uses a case example of one of the largest effectiveness trials of behavioral treatment for co-occurring SUD/PTSD conducted within the National Drug Abuse Treatment Clinical Trials Network (NIDA CTN) and producing 19 publications. The paper concludes with implications of this secondary analytic approach to improve addiction researchers’ ability to identify best practices for community-based treatment of these disorders. Innovative methods are needed to maximize the benefits of clinical studies and better support SUD/PTSD treatment options for both specialty and non-specialty healthcare settings. Moving forward, planning for and description of secondary analyses in randomized trials should be given equal

  8. Maximizing Effectiveness Trials in PTSD and SUD Through Secondary Analysis: Benefits and Limitations Using the National Institute on Drug Abuse Clinical Trials Network "Women and Trauma" Study as a Case Example.

    PubMed

    Hien, Denise A; Campbell, Aimee N C; Ruglass, Lesia M; Saavedra, Lissette; Mathews, Abigail G; Kiriakos, Grace; Morgan-Lopez, Antonio

    2015-09-01

    Recent federal legislation and a renewed focus on integrative care models underscore the need for economical, effective, and science-based behavioral health care treatment. As such, maximizing the impact and reach of treatment research is of great concern. Behavioral health issues, including the frequent co-occurrence of substance use disorders (SUD) and posttraumatic stress disorder (PTSD), are often complex, with a myriad of factors contributing to the success of interventions. Although treatment guides for comorbid SUD/PTSD exist, most patients continue to suffer symptoms following the prescribed treatment course. Further, the study of efficacious treatments has been hampered by methodological challenges (e.g., overreliance on "superiority" designs (i.e., designs structured to test whether or not one treatment statistically surpasses another in terms of effect sizes) and short term interventions). Secondary analyses of randomized controlled clinical trials offer potential benefits to enhance understanding of findings and increase the personalization of treatment. This paper offers a description of the limits of randomized controlled trials as related to SUD/PTSD populations, highlights the benefits and potential pitfalls of secondary analytic techniques, and uses a case example of one of the largest effectiveness trials of behavioral treatment for co-occurring SUD/PTSD conducted within the National Drug Abuse Treatment Clinical Trials Network (NIDA CTN) and producing 19 publications. The paper concludes with implications of this secondary analytic approach to improve addiction researchers' ability to identify best practices for community-based treatment of these disorders. Innovative methods are needed to maximize the benefits of clinical studies and better support SUD/PTSD treatment options for both specialty and non-specialty healthcare settings. Moving forward, planning for and description of secondary analyses in randomized trials should be given equal

  9. Who benefits from child benefit?

    PubMed

    Blow, Laura; Walker, Ian; Zhu, Yu

    2012-01-01

    Governments, over much of the developed world, make significant financial transfers to parents with dependent children. For example, in the United States the recently introduced Child Tax Credit (CTC), which goes to almost all children, costs almost $1 billion each week, or about 0.4% of GNP. The United Kingdom has even more generous transfers and spends an average of about $30 a week on each of about 8 million children—about 1% of GNP. The typical rationale given for these transfers is that they are good for our children and here we investigate the effect of such transfers on household spending patterns. In the United Kingdom such transfers, known as Child Benefit (CB), have been simple lump sum universal payments for a continuous period of more than 20 years. We do indeed find that CB is spent differently from other income—paradoxically, it appears to be spent disproportionately on adult-assignable goods. In fact, we estimate that as much as half of a marginal dollar of CB is spent on alcohol. We resolve this puzzle by showing that the effect is confined to unanticipated variation in CB so we infer that parents are sufficiently altruistic toward their children that they completely insure them against shocks. PMID:22329051

  10. Who benefits from child benefit?

    PubMed

    Blow, Laura; Walker, Ian; Zhu, Yu

    2012-01-01

    Governments, over much of the developed world, make significant financial transfers to parents with dependent children. For example, in the United States the recently introduced Child Tax Credit (CTC), which goes to almost all children, costs almost $1 billion each week, or about 0.4% of GNP. The United Kingdom has even more generous transfers and spends an average of about $30 a week on each of about 8 million children—about 1% of GNP. The typical rationale given for these transfers is that they are good for our children and here we investigate the effect of such transfers on household spending patterns. In the United Kingdom such transfers, known as Child Benefit (CB), have been simple lump sum universal payments for a continuous period of more than 20 years. We do indeed find that CB is spent differently from other income—paradoxically, it appears to be spent disproportionately on adult-assignable goods. In fact, we estimate that as much as half of a marginal dollar of CB is spent on alcohol. We resolve this puzzle by showing that the effect is confined to unanticipated variation in CB so we infer that parents are sufficiently altruistic toward their children that they completely insure them against shocks.

  11. Simply the best: teaching gerontological nursing students to teach evidence-based practice. Creating tip sheets can help achieve the goal of implementing EBP in clinical facilities.

    PubMed

    Schoenfelder, Deborah Perry

    2007-08-01

    This article describes a teaching strategy used in an undergraduate gerontological nursing clinical course to familiarize students with evidence-based practice. Students are required to read and summarize an assigned evidence-based practice guideline published by The University of Iowa Gerontological Nursing Interventions Research Center. They then develop a "tip sheet," based on the assigned guideline, to disseminate to health care staff at their practicum sites, which is either a long-term care facility or a hospital-based skilled nursing facility. Nursing students' reactions to the assignment and nursing staff's responses to the tip sheets are discussed.

  12. Long-Term (Six Years) Clinical Outcome Discrimination of Patients in the Vegetative State Could be Achieved Based on the Operational Architectonics EEG Analysis: A Pilot Feasibility Study.

    PubMed

    Fingelkurts, Andrew A; Fingelkurts, Alexander A; Bagnato, Sergio; Boccagni, Cristina; Galardi, Giuseppe

    2016-01-01

    Electroencephalogram (EEG) recordings are increasingly used to evaluate patients with disorders of consciousness (DOC) or assess their prognosis outcome in the short-term perspective. However, there is a lack of information concerning the effectiveness of EEG in classifying long-term (many years) outcome in chronic DOC patients. Here we tested whether EEG operational architectonics parameters (geared towards consciousness phenomenon detection rather than neurophysiological processes) could be useful for distinguishing a very long-term (6 years) clinical outcome of DOC patients whose EEGs were registered within 3 months post-injury. The obtained results suggest that EEG recorded at third month after sustaining brain damage, may contain useful information on the long-term outcome of patients in vegetative state: it could discriminate patients who remain in a persistent vegetative state from patients who reach a minimally conscious state or even recover a full consciousness in a long-term perspective (6 years) post-injury. These findings, if confirmed in further studies, may be pivotal for long-term planning of clinical care, rehabilitative programs, medical-legal decisions concerning the patients, and policy makers. PMID:27347266

  13. Long-Term (Six Years) Clinical Outcome Discrimination of Patients in the Vegetative State Could be Achieved Based on the Operational Architectonics EEG Analysis: A Pilot Feasibility Study

    PubMed Central

    Fingelkurts, Andrew A.; Fingelkurts, Alexander A.; Bagnato, Sergio; Boccagni, Cristina; Galardi, Giuseppe

    2016-01-01

    Electroencephalogram (EEG) recordings are increasingly used to evaluate patients with disorders of consciousness (DOC) or assess their prognosis outcome in the short-term perspective. However, there is a lack of information concerning the effectiveness of EEG in classifying long-term (many years) outcome in chronic DOC patients. Here we tested whether EEG operational architectonics parameters (geared towards consciousness phenomenon detection rather than neurophysiological processes) could be useful for distinguishing a very long-term (6 years) clinical outcome of DOC patients whose EEGs were registered within 3 months post-injury. The obtained results suggest that EEG recorded at third month after sustaining brain damage, may contain useful information on the long-term outcome of patients in vegetative state: it could discriminate patients who remain in a persistent vegetative state from patients who reach a minimally conscious state or even recover a full consciousness in a long-term perspective (6 years) post-injury. These findings, if confirmed in further studies, may be pivotal for long-term planning of clinical care, rehabilitative programs, medical-legal decisions concerning the patients, and policy makers. PMID:27347266

  14. Commentary: Is There Clinical Benefit From Using a Diode or Neodymium:Yttrium-Aluminum-Garnet Laser in the Treatment of Periodontitis?

    PubMed

    Cobb, Charles M

    2016-10-01

    Despite a quarter of a century of laser research, there is a persistent debate regarding the efficacy of dental lasers in the treatment of periodontitis or periodontal maintenance therapy. There are many claims and much hyperbole surrounding the use of lasers, either as a monotherapy or adjunctive to scaling and root planing, to treat periodontitis. There is little evidence that using a diode or neodymium:yttrium-aluminum-garnet laser adds clinical value over and above conventional non-surgical or surgical periodontal treatment. There is a significant need for better designed human clinical trials. Data from such trials should be analyzed according to initial probing depth and characteristics of the treated sites, such as non-molar, molar flat surfaces, and molar furcations, and evaluated for long-term post-treatment results. PMID:27181116

  15. Durable Clinical Benefit of Pertuzumab in a Young Patient with BRCA2 Mutation and HER2-Overexpressing Breast Cancer Involving the Brain

    PubMed Central

    Koumarianou, Anna; Kontopoulou, Christina; Kouloulias, Vassilis; Tsionou, Christina

    2016-01-01

    Patients with HER2-positive breast cancer and brain metastases have limited treatment options, and, as a result of their poor performance status and worse prognosis, they are underrepresented in clinical trials. Not surprisingly, these patients may not be fit enough to receive any active treatment and are offered supportive therapy. BRCA2 mutations are reported to be rarely associated with HER2-overexpressing advanced breast cancer and even more rarely with brain metastases at diagnosis. We report on a BRCA2-positive breast cancer patient with metastatic disease in multiple sites, including the brain, and poor performance status who exhibited an extraordinary clinical and imaging response to the novel anti-HER2 therapy pertuzumab after multiple lines of therapy including anti-HER2 targeting. To our knowledge, the clinicopathologic and therapeutic characteristics of this patient point to a unique case and an urgent need for further investigation of pertuzumab in patients with brain metastases. PMID:27195161

  16. Commentary: Is There Clinical Benefit From Using a Diode or Neodymium:Yttrium-Aluminum-Garnet Laser in the Treatment of Periodontitis?

    PubMed

    Cobb, Charles M

    2016-10-01

    Despite a quarter of a century of laser research, there is a persistent debate regarding the efficacy of dental lasers in the treatment of periodontitis or periodontal maintenance therapy. There are many claims and much hyperbole surrounding the use of lasers, either as a monotherapy or adjunctive to scaling and root planing, to treat periodontitis. There is little evidence that using a diode or neodymium:yttrium-aluminum-garnet laser adds clinical value over and above conventional non-surgical or surgical periodontal treatment. There is a significant need for better designed human clinical trials. Data from such trials should be analyzed according to initial probing depth and characteristics of the treated sites, such as non-molar, molar flat surfaces, and molar furcations, and evaluated for long-term post-treatment results.

  17. Effects of Dairy Products Consumption on Health: Benefits and Beliefs--A Commentary from the Belgian Bone Club and the European Society for Clinical and Economic Aspects of Osteoporosis, Osteoarthritis and Musculoskeletal Diseases.

    PubMed

    Rozenberg, Serge; Body, Jean-Jacques; Bruyère, Olivier; Bergmann, Pierre; Brandi, Maria Luisa; Cooper, Cyrus; Devogelaer, Jean-Pierre; Gielen, Evelien; Goemaere, Stefan; Kaufman, Jean-Marc; Rizzoli, René; Reginster, Jean-Yves

    2016-01-01

    Dairy products provide a package of essential nutrients that is difficult to obtain in low-dairy or dairy-free diets, and for many people it is not possible to achieve recommended daily calcium intakes with a dairy-free diet. Despite the established benefits for bone health, some people avoid dairy in their diet due to beliefs that dairy may be detrimental to health, especially in those with weight management issues, lactose intolerance, osteoarthritis, rheumatoid arthritis, or trying to avoid cardiovascular disease. This review provides information for health professionals to enable them to help their patients make informed decisions about consuming dairy products as part of a balanced diet. There may be a weak association between dairy consumption and a possible small weight reduction, with decreases in fat mass and waist circumference and increases in lean body mass. Lactose intolerant individuals may not need to completely eliminate dairy products from their diet, as both yogurt and hard cheese are well tolerated. Among people with arthritis, there is no evidence for a benefit to avoid dairy consumption. Dairy products do not increase the risk of cardiovascular disease, particularly if low fat. Intake of up to three servings of dairy products per day appears to be safe and may confer a favourable benefit with regard to bone health.

  18. Effects of Dairy Products Consumption on Health: Benefits and Beliefs--A Commentary from the Belgian Bone Club and the European Society for Clinical and Economic Aspects of Osteoporosis, Osteoarthritis and Musculoskeletal Diseases.

    PubMed

    Rozenberg, Serge; Body, Jean-Jacques; Bruyère, Olivier; Bergmann, Pierre; Brandi, Maria Luisa; Cooper, Cyrus; Devogelaer, Jean-Pierre; Gielen, Evelien; Goemaere, Stefan; Kaufman, Jean-Marc; Rizzoli, René; Reginster, Jean-Yves

    2016-01-01

    Dairy products provide a package of essential nutrients that is difficult to obtain in low-dairy or dairy-free diets, and for many people it is not possible to achieve recommended daily calcium intakes with a dairy-free diet. Despite the established benefits for bone health, some people avoid dairy in their diet due to beliefs that dairy may be detrimental to health, especially in those with weight management issues, lactose intolerance, osteoarthritis, rheumatoid arthritis, or trying to avoid cardiovascular disease. This review provides information for health professionals to enable them to help their patients make informed decisions about consuming dairy products as part of a balanced diet. There may be a weak association between dairy consumption and a possible small weight reduction, with decreases in fat mass and waist circumference and increases in lean body mass. Lactose intolerant individuals may not need to completely eliminate dairy products from their diet, as both yogurt and hard cheese are well tolerated. Among people with arthritis, there is no evidence for a benefit to avoid dairy consumption. Dairy products do not increase the risk of cardiovascular disease, particularly if low fat. Intake of up to three servings of dairy products per day appears to be safe and may confer a favourable benefit with regard to bone health. PMID:26445771

  19. Comparative clinical and psychosocial benefits of tooth bleaching: different light activation of a 38% peroxide gel in a preliminary case-control study.

    PubMed

    Calderini, Angelo; Sciara, Simona; Semeria, Chiara; Pantaleo, Giuseppe; Polizzi, Elisabetta

    2016-08-01

    Tooth bleaching is a widespread dental treatment with important psychosocial antecedents and outcomes involved. In the activation of in-office bleaching agents, a selective light radiation, that is, a diode laser seems to be a positive choice to decrease the time of bleaching without surface modification and with no residual tooth sensitivity for maximum effect and minimal clinical and psychological side effects. PMID:27525071

  20. Assessment of clinical benefit and quality of life in patients undergoing cytoreduction and Hyperthermic Intraperitoneal Chemotherapy (HIPEC) for management of peritoneal metastases

    PubMed Central

    Hanna, Nader; Boutros, Cherif; Alexander, H. Richard

    2013-01-01

    Peritoneal metastasis is a significant clinical challenge; life expectancy following diagnosis is usually very short. Surgical cytoreduction with HIPEC is being used with increasing frequency in selected patients; most outcome data have shown that prolonged median survivals can be observed in selected patients. This review summarizes the published data related to outcome and quality of life after cytoreduction and HIPEC to provide insights into its use in patients with peritoneal carcinomatosis. PMID:23450068

  1. All the Vice Chancellor’s Neuroscientists: Unity to Achieve Success in Solving Malaysia’s Diseases via Upgrading Clinical Services and Neuroscience Research

    PubMed Central

    Abdullah, Jafri Malin

    2013-01-01

    President Obama of the United States of America announced this April the Brain Research Through Advancing Innovative Neurotechnologies (BRAIN for short) investment, while Professor Henry Markram’s team based in the European Union will spend over a billion euros on the Human Brain Project, breaking through the unknowns in the fifth science of the decade: Neuroscience. Malaysia's growth in the same field needs to be augmented, and thus the Universiti Sains Malaysia’s vision is to excel in the field of clinical brain sciences, mind sciences and neurosciences. This will naturally bring up the level of research in the country simultaneously. Thus, a center was recently established to coordinate this venture. The four-year Integrated Neuroscience Program established recently will be a sustainable source of neuroscientists for the country. We hope to establish ourselves by 2020 as a global university with neurosciences research as an important flagship. PMID:23966818

  2. Similar Clinical and Surgical Outcomes Achieved with Early Compared to Late Anti-TNF Induction in Mild-to-Moderate Ulcerative Colitis: A Retrospective Cohort Study

    PubMed Central

    Fedorak, Darryl K.; Dieleman, Levinus A.; Halloran, Brendan P.

    2016-01-01

    Background. Biologic agents targeting tumor necrosis factor alpha are effective in the management of ulcerative colitis (UC), but their use is often postponed until after failure of other treatment modalities. Objectives. We aim to determine if earlier treatment with infliximab or adalimumab alters clinical and surgical outcomes in UC patients. Methods. A retrospective cohort study was conducted evaluating UC outpatients treated with infliximab or adalimumab from 2003 to 2014. Patients were stratified by time to first anti-TNF exposure; early initiation was defined as starting treatment within three years of diagnosis. Primary outcomes were colectomy, UC-related hospitalization, and clinical secondary loss of response. Kaplan-Meier analysis was used to assess time to the primary outcomes. Results. 115 patients were included (78 infliximab, 37 adalimumab). Median follow-up was 175.6 weeks (IQR 72.4–228.4 weeks). Fifty-seven (49.6%) patients received early anti-TNF therapy; median time to treatment in this group was 38.1 (23.3–91.0) weeks compared to 414.0 (254.0–561.3) weeks in the late initiator cohort (p < 0.0001). Patients treated with early anti-TNF therapy had more severe endoscopic disease at induction (mean Mayo endoscopy subscore 2.46 (SD ± 0.66) versus 1.86 (±0.67), p < 0.001) and trended towards increased risk of colectomy (17.5% versus 8.6%, p = 0.16) and UC-related hospitalization (43.9% versus 27.6%, p = 0.07). In multivariate regression analysis, early anti-TNF induction was not associated with colectomy (HR 2.02 [95% CI: 0.57–7.20]), hospitalization (HR 1.66 [0.84–3.30]), or secondary loss of response (HR 0.86 [0.52–1.42]). Conclusions. Anti-TNF therapy is initiated earlier in patients with severe UC but earlier treatment does not prevent hospitalization, colectomy, or secondary loss of response. PMID:27478817

  3. Clinical benefit of adenosine as an adjunct to reperfusion in ST-elevation myocardial infarction patients: An updated meta-analysis of randomized controlled trials

    PubMed Central

    Bulluck, Heerajnarain; Sirker, Alex; Loke, Yoon K.; Garcia-Dorado, David; Hausenloy, Derek J.

    2016-01-01

    Background Adenosine administered as an adjunct to reperfusion can reduce coronary no-reflow and limit myocardial infarct (MI) size in ST-segment elevation myocardial infarction (STEMI) patients. Whether adjunctive adenosine therapy can improve clinical outcomes in reperfused STEMI patients is not clear and is investigated in this meta-analysis of 13 randomized controlled trials (RCTs). Methods We performed an up-to-date search for all RCTs investigating adenosine as an adjunct to reperfusion in STEMI patients. We calculated pooled relative risks using a fixed-effect meta-analysis assessing the impact of adjunctive adenosine therapy on major clinical endpoint including all-cause mortality, non-fatal myocardial infarction, and heart failure. Surrogate markers of reperfusion were also analyzed. Results 13 RCTs (4273 STEMI patients) were identified and divided into 2 subgroups: intracoronary adenosine versus control (8 RCTs) and intravenous adenosine versus control (5 RCTs). In patients administered intracoronary adenosine, the incidence of heart failure was significantly lower (risk ratio [RR] 0.44 [95% CI 0.25–0.78], P = 0.005) and the incidence of coronary no-reflow was reduced (RR for TIMI flow<3 postreperfusion 0.68 [95% CI 0.47–0.99], P = 0.04). There was no difference in heart failure incidence in the intravenous adenosine group but most RCTs in this subgroup were from the thrombolysis era. There was no difference in non-fatal MI or all-cause mortality in both subgroups. Conclusion We find evidence of improved clinical outcome in terms of less heart failure in STEMI patients administered intracoronary adenosine as an adjunct to reperfusion. This finding will need to be confirmed in a large adequately powered prospective RCT. PMID:26402450

  4. Implant-supported overdenture manufactured using CAD/CAM techniques to achieve horizontal path insertion between the primary and secondary structure: A clinical case report

    PubMed Central

    Agustín-Panadero, Rubén; Peñarrocha-Oltra, David; Gomar-Vercher, Sonia; Ferreiroa, Alberto

    2015-01-01

    This report describes the case of an edentulous patient with an atrophic maxilla and severe class III malocclusion. Prosthetic rehabilitation was performed using CAD/CAM techniques for manufacturing an implant-supported overdenture with horizontal insertion. A vestibulo-lingual insertion overdenture is a precision prosthesis with a fixation system affording a good fit between the primary and secondary structure. Both structures exhibit passive horizontal adjustment. This treatment option requires the same number of implants as implant-supported fixed dentures. The horizontal assembly system prevents the prosthesis from loosening or moving in response to axial and non-axial forces. The technique was used to rehabilitate a patient presenting an atrophic upper maxilla, with the insertion of 8 implants. No complications were reported at follow-up 3, 6 and 12 months after fitting of the prosthesis. This system offers solutions to the clinical and laboratory complications associated with hybrid prostheses, concealing emergence of the chimneys and improving implant-prosthesis hygiene. PMID:26140179

  5. [Achievement of therapeutic target in subjects on statin treatment in clinical practice. Results of the STAR (Statins Target Assessment in Real practice) study].

    PubMed

    Degli Esposti, Luca; Sangiorgi, Diego; Arca, Marcello; Vigna, Giovanni B; Budal, Stefano; Degli Esposti, Ezio

    2011-12-01

    The primary aim of the STAR Study (Statins Target Assessment in Real practice) was to determine the LDL-cholesterol reduction and to analyse patient's and therapeutic factors associated to LDL-cholesterol target attainment in newly treated subjects with statins in an unselected population in clinical practice setting. Administrative databases (including pharmaceutical prescriptions and hospital admissions) and laboratory test databases (including LDL-cholesterol values) of five local health units, distributed in Emilia Romagna, Toscana and Umbria, were linked. A retrospective cohort study was conducted and all subjects aged > or =18 years with a first prescription for statins (newly treated subjects) between January 1st, 2007 and June 30th, 2008 were included. All statin prescriptions over a 12 months follow-up period were considered and used to calculate adherence to treatment. Baseline and follow-up LDL-cholesterol, respectively, were defined according to the nearest determination to the first prescription for statins and to the end of the follow-up period. A total of 3.232 subjects was included, 1.516 males (47%) and 1.716 females (53%), with an average age equal to 65.9 +/- 11.3 years. Among included subjects, 22.,6% had a gap to LDL-cholesterol target <10%, 30.0% between 10 and 29%, 20.7% between 30 and 49%, and 26.7% . or =50%. Among those with a gap to target > or =50%, 30-49%, and 10-29%, respectively, LDL-cholesterol target was attained by 7.1%, 41.8%, and 62.% of subjects. LDL-cholesterol target attainment was associated to gap to target, adherence with treatment, and type of statin. PMID:22567731

  6. The Benefits of Good Teaching Extend beyond Course Achievement

    ERIC Educational Resources Information Center

    Loes, Chad N.; Pascarella, Ernest T.

    2015-01-01

    This paper synthesizes research from the Wabash National Study on Liberal Arts Education, the National Study on Student Learning, and the Research on Iowa Student Experiences study that estimates the influence of certain effective instructional practices on a range of student outcomes. Student perceptions of two specific teacher…

  7. Benefits of maltodextrin intake 2 hours before cholecystectomy by laparotomy in respiratory function and functional capacity: a prospective randomized clinical trial

    PubMed Central

    Zani, Fabiana Vieira Breijão; Aguilar-Nascimento, José Eduardo; Nascimento, Diana Borges Dock; da Silva, Ageo Mário Cândido; Caporossi, Fernanda Stephan; Caporossi, Cervantes

    2015-01-01

    ABSTRACT Objective: To evaluate the change in respiratory function and functional capacity according to the type of preoperative fasting. Methods: Randomized prospective clinical trial, with 92 female patients undergoing cholecystectomy by laparotomy with conventional or 2 hours shortened fasting. The variables measured were the peak expiratory flow, forced expiratory volume in the first second, forced vital capacity, dominant handgrip strength, and non-dominant handgrip strength. Evaluations were performed 2 hours before induction of anesthesia and 24 hours after the operation. Results: The two groups were similar in preoperative evaluations regarding demographic and clinical characteristics, as well as for all variables. However, postoperatively the group with shortened fasting had higher values than the group with conventional fasting for lung function tests peak expiratory flow (128.7±62.5 versus 115.7±59.9; p=0.040), forced expiratory volume in the first second (1.5±0.6 versus 1.2±0.5; p=0.040), forced vital capacity (2.3±1.1 versus 1.8±0.9; p=0.021), and for muscle function tests dominant handgrip strength (24.9±6.8 versus 18.4±7.7; p=0.001) and non-dominant handgrip strength (22.9±6.3 versus 17.0±7.8; p=0.0002). In the intragroup evaluation, there was a decrease in preoperative compared with postoperative values, except for dominant handgrip strength (25.2±6.7 versus 24.9±6.8; p=0.692), in the shortened fasting group. Conclusion: Abbreviation of preoperative fasting time with ingestion of maltodextrin solution is beneficial to pulmonary function and preserves dominant handgrip strength. PMID:26154547

  8. Do Classroom Volunteers Benefit Schools?

    ERIC Educational Resources Information Center

    Brent, Brian O.

    2000-01-01

    A study of 575 volunteers in 57 elementary schools discovered that most are women (aged 36-55) supporting classroom and learning activities. Volunteers improve climate, individual student achievement, and school-community relations. Poorer schools lack sufficient volunteers. Benefits outweigh administrative, recruitment, and training costs. (MLH)

  9. Benefits of Multilingualism in Education

    ERIC Educational Resources Information Center

    Okal, Benard Odoyo

    2014-01-01

    The article gives a brief analytical survey of multilingualism practices, its consequences, its benefits in education and discussions on the appropriate ways towards its achievement in education. Multilingualism refers to speaking more than one language competently. Generally there are both the official and unofficial multilingualism practices. A…

  10. An exploratory intervention study suggests clinical benefits of training in chronic stroke to be paralleled by changes in brain activity using repeated fMRI

    PubMed Central

    Landsmann, Barbara; Pinter, Daniela; Pirker, Eva; Pichler, Gerald; Schippinger, Walter; Weiss, Elisabeth M; Mathie, Gabriel; Gattringer, Thomas; Fazekas, Franz; Enzinger, Christian

    2016-01-01

    Purpose Previous studies demonstrated changes in sensorimotor network activation over time after stroke that have been interpreted as partly compensatory. Locomotor and balance trainings may improve both mobility and cognition even in chronic stroke and thereby impact on cerebral activation patterns. We here aimed at testing these assumptions in an exploratory study to inform subsequent larger intervention studies. Patients and methods Eight patients (73.3±4.4 years) with a chronic lacunar stroke (mean interval 3.7 years after the acute event with a range from 2 to 4 years) and residual leg paresis leading to gait disturbance received a guided 5-week training focusing on mobility, endurance, and coordination. Before and afterward, they underwent clinical, neuropsychological, and gait assessments and brain MRI at 3 T including a functional ankle movement paradigm. Sixteen healthy controls (HCs; 68.8±5.4 years) followed the same protocol without intervention. Results After training, patients had improved in mobility, memory, and delayed recall of memory. While cerebral activations in HC remained completely unaltered, patients showed increased activations in the right precentral gyrus, the right and left superior frontal gyri, and the right frontal lobe, with bipedal ankle movements after training. Conclusion In this exploratory study of chronic stroke, we found not only significant effects of physical training on mobility but also distinct aspects of cognition already with a small number of highly selected patients. These improvements were paralleled by alterations in cerebral activity possibly reflecting neuronal plasticity. Larger studies including randomization are needed. PMID:26869779

  11. Achieving excellence using an advanced biomaterial: part 1.

    PubMed

    Terry, Douglas A; Leinfelder, Karl F; Blatz, Markcus B

    2009-08-01

    Advancements in material research and adhesive technology have enabled the development of freehand bonding techniques that allow the preservation of remaining tooth structure and conservation of tooth structure during preparation-all while reinforcing the remaining tooth structure and improving the longevity and aesthetics of the restoration. In this article, the clinical concepts discussed were utilized with a recently developed composite resin material to restore the maxillary anterior dentition. Although the long-term benefits of this material remain to be determined, the utilization of this nanohybrid composite in this clinical presentation demonstrated an optimal functional and natural aesthetic result in the anterior region. Part 2 of this article will address the principles, techniques, and other considerations for achieving clinical success with direct posterior composite resin restorations.

  12. Achieving effective supervision.

    PubMed

    Kavanagh, David J; Spence, Susan H; Wilson, Jill; Crow, Natasha

    2002-09-01

    Supervision probably does have benefits both for the maintenance and improvement of clinical skills and for job satisfaction, but the data are very thin and almost non-existent in the area of alcohol and other drugs services. Because of the potential complexity of objectives and roles in supervision, a structured agreement appears to be an important part of the effective supervision relationship. Because sessions can degenerate easily into unstructured socialization, agendas and session objectives may also be important. While a working alliance based on mutual respect and trust is an essential base for the supervision relationship, procedures for direct observation of clinical skills, demonstration of new procedures and skills practice with detailed feedback appear critical to supervision's impact on practice. To ensure effective supervision, there needs not only to be a minimum of personnel and resources, but also a compatibility with the values and procedures of management and staff, access to supervision training and consultation and sufficient incentives to ensure it continues. PMID:12270075

  13. Home Media and Children's Achievement and Behavior

    ERIC Educational Resources Information Center

    Hofferth, Sandra L.

    2010-01-01

    This study provides a national picture of the time American 6- to 12-year-olds spent playing video games, using the computer, and watching TV at home in 1997 and 2003, and the association of early use with their achievement and behavior as adolescents. Girls benefited from computer use more than boys, and Black children benefited more than White…

  14. Pharmacy benefit management companies.

    PubMed

    Taniguchi, R

    1995-09-01

    The principal services offered by pharmacy benefit management companies (PBMs) are described. A PBM contracts with employers, insurers, and others to provide accessible and cost-effective benefits to those groups' members. PBMs vary in their organization and services because they originate from different types of businesses. Many PBMs have been formed by publicly traded companies that have combined traditional ways of controlling cost and use, such as formularies, with new elements to form organizations whose primary function is managing the pharmacy benefit. Often, the PBM is paid a fixed amount for which it must provide all contracted services. PBMs may provide pharmacy services themselves (e.g., mail order prescription service is offered by Medco, one of the largest PBMs); more often, they subcontract with others to provide certain services. Full-service PBMs have the following functions: establishing networks of pharmacies for use by plan members; processing claims electronically at the time a prescription is filled and thus maintaining a database on drug use and cost; using these data to generate various reports; encouraging the use of generic products; managing existing formularies, helping to establish customized formularies, or providing a national formulary; providing information to support formulary guidelines (counter-detailing); offering programs in which prescriptions for maintenance medications are filled less frequently with larger amounts, often by mail order; negotiating volume-based rebates from manufacturers; performing drug-use review; developing disease management programs based on clinical practice guidelines and measurements of patient outcome; and evaluating outcomes by combining data on drug therapy with information about other parts of the patient's care.(ABSTRACT TRUNCATED AT 250 WORDS)

  15. Graded Achievement, Tested Achievement, and Validity

    ERIC Educational Resources Information Center

    Brookhart, Susan M.

    2015-01-01

    Twenty-eight studies of grades, over a century, were reviewed using the argument-based approach to validity suggested by Kane as a theoretical framework. The review draws conclusions about the meaning of graded achievement, its relation to tested achievement, and changes in the construct of graded achievement over time. "Graded…

  16. Achieving scale strategies for sustained competitive performance.

    PubMed

    Grube, Mark E; Gish, Ryan S; Tkach, Sasha N

    2008-05-01

    Growth to achieve scale requires the following strategic initiatives: Having a clear understanding of what the organization is and what it wants to become. Ensuring a structured and rigorous growth process. Leveraging size to achieve benefits of scale. Recognizing the importance of physicians, ambulatory care, and primary care. Establishing and maintaining accountability as growth occurs.

  17. A holistic approach on the neurological benefits of music.

    PubMed

    Jimenez-Dabdoub, Lily; Catterall, Jenn

    2015-09-01

    A holistic perspective on human beings allows health carers to achieve an understanding of all the physiological, psychological and social disturbances of the patient as a whole. Through this article we wish to focus on how music has holistic neurological benefits. Music-therapy interventions can be more accessible and even "self-managed" by the patient's relatives. They can reinforce social cohesion, family ties and patients' self-esteem and thus produce a better quality of life. Overall, it is important to consider the benefits that an evolutionary understanding of musical behaviour and a holistic clinical perspective of the role of music may bring for rehabilitation of a wide range of symptoms and conditions.

  18. A holistic approach on the neurological benefits of music.

    PubMed

    Jimenez-Dabdoub, Lily; Catterall, Jenn

    2015-09-01

    A holistic perspective on human beings allows health carers to achieve an understanding of all the physiological, psychological and social disturbances of the patient as a whole. Through this article we wish to focus on how music has holistic neurological benefits. Music-therapy interventions can be more accessible and even "self-managed" by the patient's relatives. They can reinforce social cohesion, family ties and patients' self-esteem and thus produce a better quality of life. Overall, it is important to consider the benefits that an evolutionary understanding of musical behaviour and a holistic clinical perspective of the role of music may bring for rehabilitation of a wide range of symptoms and conditions. PMID:26417751

  19. The Impact of VA's Geriatric Research, Education and Clinical Centers on Academic Affiliates

    ERIC Educational Resources Information Center

    Bragg, Elizabeth J.; Meganathan, Karthikeyan; Shay, Kenneth; Gilman, Stuart C.; Zeiss, Robert A.; Hettler, Debbie L.

    2011-01-01

    The education mission of the Department of Veterans Affairs (VA) is to train health professionals to benefit VA and the United States. One approach for achieving that mission, along with VA's research and clinical missions, was the establishment of Geriatric Research, Education and Clinical Centers (GRECCs) in 1975. These were developed at VA…

  20. Clinical use of three-dimensional video measurements of eye movements

    NASA Technical Reports Server (NTRS)

    Merfeld, D. M.; Black, F. O.; Wade, S.; Paloski, W. H. (Principal Investigator)

    1998-01-01

    Noninvasive measurements of three-dimensional eye position can be accurately achieved with video methods. A case study showing the potential clinical benefit of these enhanced measurements is presented along with some thoughts about technological advances, essential for clinical application, that are likely to occur in the next several years.

  1. Great social benefits.

    PubMed

    Huang, B

    1991-06-01

    The Integrated Project (IP), originated by the Japanese Organization for International Cooperation in Family Planning (JOICFP) was started in China in 1984. The 2nd phase covered 210,000 people in 8 townships in Inner Mongolia Autonomous Region, and others in Liaoning, Jiangsu and Shandong Provinces, in 1987-1989. 2 pilot areas, monitored by representatives from IPPF's East and Southeast Asia and Oceania Region in September 1990, showed significant gains in contraceptive prevalence as well as health benefits and community acceptance. The IP consists of integrated family planning, maternal and child health and parasite control for rural areas. In Tumotezuo County, Inner Mongolia, the village of Bashi with 2526 people was mobilized to construct its own health clinic with a delivery room and a maternal and child health unit, where night classes were held for women. Because of antihelminthic treatment, installation of water pipes and toilets, parasites were controlled. Neighboring towns benefited by treatment of common disorders such as anemia and rickets. In the pilot areas there have been no maternal deaths in 3 years, and declines in perinatal mortality from 33.3 to 17.9/1000, and in infant mortality from 35.1 to 21.5/1000. Incidence of roundworm infection fell from 27.8 to 7.6%, Contraceptive prevalence, already high at 91.8%, rose to 93.7% among the Han majority, and from 65.9 to 77.2% in minorities. Family planning was spread by using the "core household" approach. The large household of the village leader, with 13 women of childbearing age, subscribed to several periodicals on family planning and farm and home economics, so people learned how to become well off by raising vegetables and pigs, and how to limit family size with the correct concept of a happy healthy family.

  2. Student Team Achievement Divisions (STAD) Technique through the Moodle to Enhance Learning Achievement

    ERIC Educational Resources Information Center

    Tiantong, Monchai; Teemuangsai, Sanit

    2013-01-01

    One of the benefits of using collaborative learning is enhancing learning achievement and increasing social skills, and the second benefits is as the more students work together in collaborative groups, the more they understand, retain, and feel better about themselves and their peers, moreover working together in a collaborative environment…

  3. Exercise: Benefits of Exercise

    MedlinePlus

    ... version of this page please turn Javascript on. Exercise: Benefits of Exercise Health Benefits One of the Healthiest Things You ... activity campaign from the National Institute on Aging. Exercise or Physical Activity? Some people may wonder what ...

  4. Benefits Outgrow Salaries

    ERIC Educational Resources Information Center

    Chemical and Engineering News, 1973

    1973-01-01

    Discusses employee benefits offered to various manufacturing industry workers, especially for chemical professionals. Indicates that in the chemicals and allied products industry, such benefits averaged more than 30 percent of payroll in 1971. (CC)

  5. Meal replacements and fibre supplement as a strategy for weight loss. Proprietary PGX® meal replacement and PGX® fibre supplement in addition to a calorie-restricted diet to achieve weight loss in a clinical setting.

    PubMed

    Reichert, Ronald G; Reimer, Raylene A; Kacinik, Veronica; Pal, Sebely; Gahler, Roland J; Wood, Simon

    2013-01-01

    Meal replacements and viscous soluble fibre represent safe and sustainable aids for weight loss. Our purpose was to determine if PGX® meal replacements and PGX(®) fibre complex in combination with a calorie-restricted diet would aid in weight loss in a clinical setting. Fifty-two overweight and obese participants (49 women, 3 men; average age 47.1 years) with a mean body mass index (BMI) of 33.8 ± 6.4 kg/m(2) consumed 57 g of proprietary PGX® meal replacement product at breakfast and another 57 g at lunch for 12 weeks. In addition to the meal replacements, they were also asked to consume 5 g/day of PGX® fibre in the form of granules, powder or capsules together with 250 mlwater. A registered dietician recommended low-fat, low-glycaemic-index foods for snacks and the dinner menus such that each volunteer was consuming a total of 1200 kcal/day. All participants (n = 52) lost a significant amount of weight from baseline (-4.69 ± 3.73 kg), which was further reflected in the reductions in their waist (-7.11 ± 6.35 cm) and hip circumference (-5.59 ± 3.58 cm) over the 12-week study (p < 0.0001). BMI scores (n = 51) were reduced by 1.6 ± 1.4 kg/m(2). The use of PGX® meal replacements and PGX(®) fibre along with a controlled dietary caloric intake is of benefit for short-term weight loss.

  6. Meal replacements and fibre supplement as a strategy for weight loss. Proprietary PGX® meal replacement and PGX® fibre supplement in addition to a calorie-restricted diet to achieve weight loss in a clinical setting.

    PubMed

    Reichert, Ronald G; Reimer, Raylene A; Kacinik, Veronica; Pal, Sebely; Gahler, Roland J; Wood, Simon

    2013-01-01

    Meal replacements and viscous soluble fibre represent safe and sustainable aids for weight loss. Our purpose was to determine if PGX® meal replacements and PGX(®) fibre complex in combination with a calorie-restricted diet would aid in weight loss in a clinical setting. Fifty-two overweight and obese participants (49 women, 3 men; average age 47.1 years) with a mean body mass index (BMI) of 33.8 ± 6.4 kg/m(2) consumed 57 g of proprietary PGX® meal replacement product at breakfast and another 57 g at lunch for 12 weeks. In addition to the meal replacements, they were also asked to consume 5 g/day of PGX® fibre in the form of granules, powder or capsules together with 250 mlwater. A registered dietician recommended low-fat, low-glycaemic-index foods for snacks and the dinner menus such that each volunteer was consuming a total of 1200 kcal/day. All participants (n = 52) lost a significant amount of weight from baseline (-4.69 ± 3.73 kg), which was further reflected in the reductions in their waist (-7.11 ± 6.35 cm) and hip circumference (-5.59 ± 3.58 cm) over the 12-week study (p < 0.0001). BMI scores (n = 51) were reduced by 1.6 ± 1.4 kg/m(2). The use of PGX® meal replacements and PGX(®) fibre along with a controlled dietary caloric intake is of benefit for short-term weight loss. PMID:24568282

  7. A Computerized Clinical Support System and Psychological Laboratory.

    ERIC Educational Resources Information Center

    Cassel, Russell N.

    1978-01-01

    Advocating "holistic" medicine, this article details the benefits to be derived from using a computerized clinical support system in a psychological laboratory focusing on internal healing where the client/patient becomes a committed partner utilizing biofeedback equipment, gaming, and simulation to achieve self-understanding and self-control. (JC)

  8. DEVELOPMENT OF A PRELIMINARY CLINICAL PREDICTION RULE TO IDENTIFY PATIENTS WITH NECK PAIN THAT MAY BENEFIT FROM A STANDARDIZED PROGRAM OF STRETCHING AND MUSCLE PERFORMANCE EXERCISE: A PROSPECTIVE COHORT STUDY

    PubMed Central

    Kolber, Morey J.; George, Steven Z.; Young, Ian; Patel, Chetan K.; Cleland, Joshua A.

    2013-01-01

    Background and Purpose: Neck pain is a significant problem and many treatment options exist. While some studies suggest exercise is beneficial for individuals with non‐specific neck pain clinicians have few tools to assist in the decision making process. Therefore, the purpose of this study was to derive a preliminary clinical prediction rule (CPR) for identifying patients with neck pain (NP) who may respond to an exercise‐based treatment program. Exercise‐based interventions have demonstrated positive outcomes in patients with NP, however it is unclear which patients are more likely to respond to this treatment approach. Methods: Consecutive patients with a primary report of nonspecific NP with or without arm pain were recruited. All patients participated in a standardized exercise program and then were classified as having a successful or non‐successful outcome at 6 weeks. Potential predictor variables were entered into a stepwise regression analysis. Variables retained in the regression model were used to develop a multivariate CPR that can be used to classify patients with NP that may benefit from exercise‐based treatment. A 6‐month follow up of the patients was used to evaluate the long‐term effects. Results: Ninety‐one patients were enrolled in the study of which 50 had a successful outcome. A CPR with 5 variables was identified (Neck Disability Index score < 18/50, presence of shoulder protraction during static postural assessment, patient does not bicycle for exercise, cervical side bending < 32°, and Fear Avoidance Belief Questionnaire–Physical Activity Score < 15). If 4 of the 5 variables were present, the probability of a successful outcome shifted from 56% to 78% (+LR 2.97). At 6 months no significant difference existed in self‐reported outcomes between those considered positive on the rule for a successful outcome and those negative on the rule for a successful outcome. Conclusions: The proposed CPR may identify patients with NP

  9. Population genetics and benefit sharing.

    PubMed

    Knoppers, B M

    2000-01-01

    The majority of international or national guidelines, specific to human genetics concentrate on actual or potential clinical applications. In contrast, the Ethics Committee of the Human Genome Organisation (HUGO) attempts to provide guidance to the bench scientists engaged in fundamental research in genomics prior to any clinical applications. Often confused as constituting the Human Genome Project (HGP) itself, HUGO's (Human Genome Organization) ultimate goal is to assist in the worldwide collaboration underpinning the HGP. It is an international organisation with 1,229 members in approximately 60 countries. The Ethics Committee is one of HUGO's six international advisory committees. Composed of experts from a number of countries and disciplines, the HUGO Ethics Committee promotes discussion and understanding of social, legal, and ethical issues as they relate to the conduct of, and knowledge derived from, the Genome Initiative. Currently, it has 13 members from 11 difference countries. It has produced statements on the conduct of genetic research, on cloning, and, has most recently presented a 'Statement on Benefit-Sharing', April 11, 2000. The Intellectual Property Committee of HUGO has been active in the controversial area of patenting. The issue of benefit-sharing is one that has its source in the mandate of both committees. How to avoid both commodification of the person through payment for access to DNA and biopiracy with no return to benefits to the families or community? While patents are a legitimate form of recognition for innovation, there seems to be no therapeutic exception to some of its stringent rules and the 'morality' exclusion has lain dormant. The HUGO 'Statement on Benefit-Sharing' examines the issues of defining community, common heritage, distributive justice and solidarity before arriving at its conclusions in benefit-sharing. This communication reviews some of these issues. PMID:11878345

  10. [Benefit assessment of drugs].

    PubMed

    Kaiser, Thomas; Vervölgyi, V; Wieseler, B

    2015-03-01

    In Germany, new drugs are subject to a benefit assessment at the time of their market access. This "early benefit assessment" is the method primarily used for the benefit assessment of pharmaceuticals in Germany. While for the authorization of a drug a positive risk-benefit ratio is sufficient, early benefit assessment examines whether the new drug has an added benefit compared with other therapies, and thus differs significantly from authorization. For the evaluation, the manufacturer is required to submit a dossier, which must contain all the relevant studies. Early benefit assessment is very transparent in international comparisons, because all the relevant data and the evaluation report will be published. The assessment is carried out with regard to the evidence-based standard of care (the "appropriate comparator"). If the new drug is found to have an additional benefit, the extent of this added benefit is assessed. In addition, groups of patients should be identified with the particular extent of the added benefit. Therefore, subgroup analyses have to be carried out frequently. Often, for new drugs, only registration studies are available. General requirements for such studies (e.g., placebo comparison, endpoints) and decisions regarding the approval process (e.g., dosage regimens) can affect the level of confidence of these studies in the benefit assessment. Joint scientific advice by regulatory authorities and HTA (health technology assessment) agencies are provided to solve this problem. However, this is not possible without additional expense for the pharmaceutical companies. PMID:25566842

  11. Achieving blood pressure goals: why aren't we?

    PubMed

    Cushman, William C; Basile, Jan

    2006-12-01

    The Seventh Report of the Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure (JNC 7) recommends a blood pressure (BP) goal of <140/90 mm Hg in patients with hypertension and <130/80 mm Hg in those with diabetes or chronic kidney disease. Achievement of BP goals is associated with significant benefits in cardiovascular morbidity and mortality. Although evidence suggests these goals are attainable, only about one third of patients are meeting them. There is a significant gap between treatment guideline recommendations and their implementation in clinical practice. Many clinicians appear satisfied with modest BP reductions and do not make the necessary treatment adjustments to achieve BP goals. Patient nonadherence is another important reason for lack of BP control. For the success of clinical trials to be reproduced in clinical practice, clinicians must recognize the importance of treating BP to goal, emphasize to patients the need to adhere to treatments, and provide persistent, goal-targeted therapy. PMID:17170612

  12. Maintenance of Clinical Efficacy and Radiographic Benefit Through Two Years of Ustekinumab Therapy in Patients With Active Psoriatic Arthritis: Results From a Randomized, Placebo‐Controlled Phase III Trial

    PubMed Central

    Puig, Lluís; Gottlieb, Alice B.; Ritchlin, Christopher; Li, Shu; Wang, Yuhua; Mendelsohn, Alan M.; Song, Michael; Zhu, Yaowei; Rahman, Proton; McInnes, Iain B.

    2015-01-01

    Objective To evaluate the efficacy and safety of ustekinumab through 2 years in adult patients with active psoriatic arthritis (PsA). Methods A total of 615 adult patients with active PsA were randomized to placebo, ustekinumab 45 mg, or ustekinumab 90 mg, at weeks 0, 4, and every 12 weeks through week 88 (last dose). At week 16, patients with <5% improvement in both tender and swollen joint counts entered blinded early escape (placebo to 45 mg, 45 mg to 90 mg, and 90 mg to 90 mg). All remaining placebo patients crossed over to ustekinumab 45 mg at week 24. Clinical efficacy measures included American College of Rheumatology criteria for 20% improvement (ACR20), Disease Activity Score in 28 joints using the C‐reactive protein level (DAS28‐CRP), and ≥75% improvement in the Psoriasis Area and Severity Index (PASI75). Radiographic progression was evaluated using the modified Sharp/van der Heijde score (SHS). Results At week 100, ACR20, DAS28‐CRP moderate/good response, and PASI75 rates ranged from 56.7–63.6%, 71.9–76.7%, and 63.9–72.5%, respectively, across the 3 treatment groups. In both ustekinumab groups, the median percent improvement in dactylitis and enthesitis was 100% at week 100. The mean changes in SHS score from week 52 to week 100 were similar to those observed from week 0 to week 52 in the ustekinumab groups. Through week 108, 70.7% and 9.7% of patients had an adverse event (AE) or serious AE, respectively. The rates and type of AEs were similar between the dose groups. Conclusion Clinical and radiographic benefits from ustekinumab treatment were maintained through week 100 in the PSUMMIT 1 study. No unexpected safety events were observed; the safety profile of ustekinumab in this population was similar to that previously observed in psoriasis patients treated with ustekinumab. PMID:26097039

  13. Non-valvular atrial fibrillation patients with none or one additional risk factor of the CHA2DS2-VASc score. A comprehensive net clinical benefit analysis for warfarin, aspirin, or no therapy.

    PubMed

    Lip, Gregory Y H; Skjøth, Flemming; Nielsen, Peter B; Larsen, Torben Bjerregaard

    2015-10-01

    Oral anticoagulation (OAC) to prevent stroke has to be balanced against the potential harm of serious bleeding, especially intracranial haemorrhage (ICH). We determined the net clinical benefit (NCB) balancing effectiveness and safety of no antithrombotic therapy, aspirin and warfarin in AF patients with none or one stroke risk factor. Using Danish registries, we determined NCB using various definitions intrinsic to our cohort (Danish weights at 1 and 5 year follow-up), with risk weights which were derived from the hazard ratio (HR) of death following an event, relative to HR of death after ischaemic stroke. When aspirin was compared to no treatment, NCB was neutral or negative for both risk strata. For warfarin vs no treatment, NCB using Danish weights was neutral where no risk factors were present and using five years follow-up. For one stroke risk factor, NCB was positive for warfarin vs no treatment, for one year and five year follow-up. For warfarin vs aspirin use in patients with no risk factors, NCB was positive with one year follow-up, but neutral with five year follow-up. With one risk factor, NCB was generally positive for warfarin vs aspirin. In conclusion, we show a positive overall advantage (i.e. positive NCB) of effective stroke prevention with OAC, compared to no therapy or aspirin with one additional stroke risk factor, using Danish weights. 'Low risk' AF patients with no additional stroke risk factors (i.e.CHA2DS2-VASc 0 in males, 1 in females) do not derive any advantage (neutral or negative NCB) with aspirin, nor with warfarin therapy in the long run.

  14. [Benefit assessment of medical devices].

    PubMed

    Zens, Yvonne; Fujita-Rohwerder, N; Windeler, J

    2015-03-01

    Medical devices play an important role in both the diagnostic and therapeutic care of patients. The hope is that particularly innovative medical devices can contribute to the improvement of patient care. However, there is no mandatory need to conduct clinical studies with medical devices that allow an assessment of their benefit within the framework of EU market access or on the way to reimbursement by the statutory health insurance (SHI) in Germany. Numerous examples show that the existing legal framework for market access and for reimbursement in the SHI system is insufficient for providing patients with only those examination and treatment methods, i. e., medical devices, that comply with the benefit requirement and the imperative for quality stipulated in the Social Code Book V. However, it is possible to conduct meaningful clinical trials, i. e., randomized controlled trials, with medical devices as well. Hence, regular, indication-related benefit assessment of medical devices with a higher risk class as a prerequisite for reimbursement for a specific medical device is not only necessary, but also feasible. The 2014 report of the Advisory Council on the Assessment of Developments in the Healthcare System contains a promising recommendation for implementing this. A regulatory framework as described in the report would allow patients the fastest possible access to safe and effective medical device innovations, while increasing planning reliability for the development and marketing of new products, which has often been criticized as insufficient by manufacturers. PMID:25566843

  15. Comparing Science Achievement Constructs: Targeted and Achieved

    ERIC Educational Resources Information Center

    Ferrara, Steve; Duncan, Teresa

    2011-01-01

    This article illustrates how test specifications based solely on academic content standards, without attention to other cognitive skills and item response demands, can fall short of their targeted constructs. First, the authors inductively describe the science achievement construct represented by a statewide sixth-grade science proficiency test.…

  16. Mobility and Reading Achievement.

    ERIC Educational Resources Information Center

    Waters, Theresa Z.

    A study examined the effect of geographic mobility on elementary school students' achievement. Although such mobility, which requires students to make multiple moves among schools, can have a negative impact on academic achievement, the hypothesis for the study was that it was not a determining factor in reading achievement test scores. Subjects…

  17. Benefits and costs of integrating technology into undergraduate nursing programs.

    PubMed

    Glasgow, Mary Ellen Smith; Cornelius, Frances H

    2005-01-01

    Advances in technology over the last decade have resulted in increased opportunities for educators to become more innovative in classroom and clinical teaching. These innovations have allowed students and faculty to access essential clinical information at the point of care/need. By capitalizing on technologies such as personal digital assistants and course delivery shells, faculty and students have both portable and remote access to information that can guide practice and learning activities in clinical, classroom, and distance settings. For instance, a student can use a personal digital assistant to research a patient's new medication at the bedside, study course information, access references during class in response to a question, or download clinical materials from home. Although the benefits of having ready access to information seem obvious, there are costs and strategic planning activities associated with implementing these projects. Clearly, the objective of any academic nursing program is to develop skills among students so they can efficiently access information and use that information to guide their nursing practice. To do so, academic nursing administrators must have the forethought to envision how new technologies can support achieving this goal as well as the ability to put in place the infrastructure supports needed for success. This article presents a case study of how one institution developed the necessary infrastructure and garnished the appropriate resources to implement an ambitious technology initiative integrated throughout a large undergraduate nursing program. In addition, how the integration of technology, online and mobile, can enhance clinical learning will be discussed.

  18. Achieving Cannabis Cessation - Evaluating N-acetylcysteine Treatment (ACCENT): Design and implementation of a multi-site, randomized controlled study in the National Institute on Drug Abuse Clinical Trials Network

    PubMed Central

    McClure, Erin A.; Sonne, Susan C.; Winhusen, Theresa; Carroll, Kathleen M.; Ghitza, Udi E.; McRae-Clark, Aimee L.; Matthews, Abigail G.; Sharma, Gaurav; Van Veldhuisen, Paul; Vandrey, Ryan G.; Levin, Frances R.; Weiss, Roger D.; Lindblad, Robert; Allen, Colleen; Mooney, Larissa J.; Haynes, Louise; Brigham, Gregory S.; Sparenborg, Steve; Hasson, Albert L.; Gray, Kevin M.

    2014-01-01

    Despite recent advances in behavioral interventions for cannabis use disorders, effect sizes remain modest, and few individuals achieve long-term abstinence. One strategy to enhance outcomes is the addition of pharmacotherapy to complement behavioral treatment, but to date no efficacious medications targeting cannabis use disorders in adults through large, randomized controlled trials have been identified. The National Institute on Drug Abuse Clinical Trials Network (NIDA CTN) is currently conducting a study to test the efficacy of N-acetylcysteine (NAC) versus placebo (PBO), added to contingency management, for cannabis cessation in adults (ages 18–50). This study was designed to replicate positive findings from a study in cannabis-dependent adolescents that found greater odds of abstinence with NAC compared to PBO. This paper describes the design and implementation of an ongoing 12-week, intent-to-treat, double-blind, randomized, placebo-controlled study with one follow-up visit four weeks post-treatment. Approximately 300 treatment-seeking cannabis-dependent adults will be randomized to NAC or PBO across six study sites in the United States. The primary objective of this 12-week study is to evaluate the efficacy of twice-daily orally-administered NAC (1200 mg) versus matched PBO, added to contingency management, on cannabis abstinence. NAC is among the first medications to demonstrate increased odds of abstinence in a randomized controlled study among cannabis users in any age group. The current study will assess the cannabis cessation efficacy of NAC combined with a behavioral intervention in adults, providing a novel and timely contribution to the evidence base for the treatment of cannabis use disorders. PMID:25179587

  19. Achieving cannabis cessation -- evaluating N-acetylcysteine treatment (ACCENT): design and implementation of a multi-site, randomized controlled study in the National Institute on Drug Abuse Clinical Trials Network.

    PubMed

    McClure, Erin A; Sonne, Susan C; Winhusen, Theresa; Carroll, Kathleen M; Ghitza, Udi E; McRae-Clark, Aimee L; Matthews, Abigail G; Sharma, Gaurav; Van Veldhuisen, Paul; Vandrey, Ryan G; Levin, Frances R; Weiss, Roger D; Lindblad, Robert; Allen, Colleen; Mooney, Larissa J; Haynes, Louise; Brigham, Gregory S; Sparenborg, Steve; Hasson, Albert L; Gray, Kevin M

    2014-11-01

    Despite recent advances in behavioral interventions for cannabis use disorders, effect sizes remain modest, and few individuals achieve long-term abstinence. One strategy to enhance outcomes is the addition of pharmacotherapy to complement behavioral treatment, but to date no efficacious medications targeting cannabis use disorders in adults through large, randomized controlled trials have been identified. The National Institute on Drug Abuse Clinical Trials Network (NIDA CTN) is currently conducting a study to test the efficacy of N-acetylcysteine (NAC) versus placebo (PBO), added to contingency management, for cannabis cessation in adults (ages 18-50). This study was designed to replicate positive findings from a study in cannabis-dependent adolescents that found greater odds of abstinence with NAC compared to PBO. This paper describes the design and implementation of an ongoing 12-week, intent-to-treat, double-blind, randomized, placebo-controlled study with one follow-up visit four weeks post-treatment. Approximately 300 treatment-seeking cannabis-dependent adults will be randomized to NAC or PBO across six study sites in the United States. The primary objective of this 12-week study is to evaluate the efficacy of twice-daily orally-administered NAC (1200 mg) versus matched PBO, added to contingency management, on cannabis abstinence. NAC is among the first medications to demonstrate increased odds of abstinence in a randomized controlled study among cannabis users in any age group. The current study will assess the cannabis cessation efficacy of NAC combined with a behavioral intervention in adults, providing a novel and timely contribution to the evidence base for the treatment of cannabis use disorders.

  20. TRANSLATIONAL PAIN RESEARCH: ACHIEVEMENTS AND CHALLENGES

    PubMed Central

    Mao, Jianren

    2009-01-01

    The achievements in both preclinical and clinical pain research over the past four decades have led to significant progresses in clinical pain management. However, pain research still faces enormous challenges and there remain many obstacles in the treatment of clinical pain, particularly chronic pain. Translational pain research needs to involve a number of important areas including a) bridging the gap between pain research and clinical pain management, b) developing objective pain assessment tools, c) analyzing current theories of pain mechanisms and their relevance to clinical pain, d) exploring new tools for both preclinical and clinical pain research, and e) coordinating research efforts among basic scientists, clinical investigators, and pain medicine practitioners. These issues are discussed in this article in light of the achievements and challenges of translational pain research. PMID:19628433

  1. What are the benefits of early patient contact? - A comparison of three preclinical patient contact settings

    PubMed Central

    2013-01-01

    Background Despite increasing attention to providing preclinical medical students with early patient experiences, little is known about associated outcomes for students. The authors compared three early patient experiences at a large American medical school where all preclinical students complete preceptorships and weekly bedside clinical-skills training and about half complete clinical, community-based summer immersion experiences. The authors asked, what are the relative outcomes and important educational components for students? Methods Medical students completed surveys at end of second year 2009–2011. In 2009, students compared/contrasted two of three approaches; responses framed later survey questions. In 2010 and 2011, students rated all three experiences in relevant areas (e.g., developing comfort in clinical setting). Investigators performed qualitative and quantitative analyses. Results Students rated bedside training more highly for developing comfort with clinical settings, one-on-one clinical-skills training, feedback, active clinical experience, quality of clinical training, and learning to be part of a team. They rated community clinical immersion and preceptorships more highly for understanding the life/practice of a physician and career/specialty decisions. Conclusions Preclinical students received different benefits from the different experiences. Medical schools should define objectives of early clinical experiences and offer options accordingly. A combination of experiences may help students achieve clinical and team comfort, clinical skills, an understanding of physicians’ lives/practices, and broad exposure for career decisions. PMID:23731514

  2. Benefits of Java

    MedlinePlus

    ... and Facts Fitness Fitness Find out more Categories Sports and Performance Training and Recovery Exercise Topics Fueling Your Workout Benefits of Physical Activity Exercise Nutrition Top Articles Man ...

  3. Clinical engagement: improving healthcare together.

    PubMed

    Riches, E; Robson, B

    2014-02-01

    Clinical engagement can achieve lasting change in the delivery of healthcare. In October 2011, Healthcare Improvement Scotland formulated a clinical engagement strategy to ensure that a progressive and sustainable approach to engaging healthcare professionals is firmly embedded in its health improvement and public assurance activities. The strategy was developed using a 90-day process, combining an evidence base of best practice and feedback from semi-structured interviews and focus groups. The strategy aims to create a culture where clinicians view working with Healthcare Improvement Scotland as a worthwhile venture, which offers a number of positive benefits such as training, career development and research opportunities. The strategy works towards developing a respectful partnership between Healthcare Improvement Scotland, the clinical community and key stakeholders whereby clinicians' contributions are recognised in a non-financial reward system. To do this, the organisation needs a sustainable infrastructure and an efficient, cost-effective approach to clinical engagement. There are a number of obstacles to achieving successful clinical engagement and these must be addressed as key drivers in its implementation. The implementation of the strategy is supported by an action and resource plan, and its impact will be monitored by a measurement plan to ensure the organisation reviews its approaches towards clinical engagement.

  4. Hospital benefit segmentation.

    PubMed

    Finn, D W; Lamb, C W

    1986-12-01

    Market segmentation is an important topic to both health care practitioners and researchers. The authors explore the relative importance that health care consumers attach to various benefits available in a major metropolitan area hospital. The purposes of the study are to test, and provide data to illustrate, the efficacy of one approach to hospital benefit segmentation analysis.

  5. The Relationship between Resources and Academic Achievement.

    ERIC Educational Resources Information Center

    Womack, Sid T.

    This paper evaluates whether or not there is a direct academic-achievement benefit from additional expenditures on education in the United States. Numerous critics have said that education is already overfunded and that it can never be funded enough to make any appreciable difference. Berliner's study of 900 school districts in Texas in the 1993…

  6. Standardization of clinical decision making for the conduct of credible clinical research in complicated medical environments.

    PubMed Central

    Morris, A. H.; East, T. D.; Wallace, C. J.; Franklin, M.; Heerman, L.; Kinder, T.; Sailor, M.; Carlson, D.; Bradshaw, R.

    1996-01-01

    The likelihood that past experience will produce correct guides to current practice depends on the signal-to-noise ratio for the clinical problem of interest. If the signal-to-noise ratio is high, the decision will be sound and patient benefit likely to occur. If the signal-to-noise ratio is low, as is commonly the case with difficult clinical decisions, then personal experience and the best intentions will not assure sound clinical decisions. When the probability of benefit cannot be quantified, clinicians in complex settings are in danger of being misled by data and experience. Quantifiable probabilities established by group experiment or observation will be necessary for clinical decisions that can be expected to confer benefit on the patient. Explicit methods are necessary for interventions that can be replicated in experiments or in practice. Computerized protocols force the articulation of explicit clinical care methods and standardize clinical decision making. We have developed explicit, rule-based protocols, implemented them in our hospital, exported them to other hospitals, and successfully achieved a rigorous experimental environment in the clinical ICU. Exportation of such explicit methods may narrow the gap between efficacy (university hospital) and effectiveness (community hospital) research results. PMID:8947700

  7. Social media and physicians: Exploring the benefits and challenges.

    PubMed

    Panahi, Sirous; Watson, Jason; Partridge, Helen

    2016-06-01

    Healthcare professionals' use of social media platforms, such as blogs, wikis, and social networking web sites has grown considerably in recent years. However, few studies have explored the perspectives and experiences of physicians in adopting social media in healthcare. This article aims to identify the potential benefits and challenges of adopting social media by physicians and demonstrates this by presenting findings from a survey conducted with physicians. A qualitative survey design was employed to achieve the research goal. Semi-structured interviews were conducted with 24 physicians from around the world who were active users of social media. The data were analyzed using the thematic analysis approach. The study revealed six main reasons and six major challenges for physicians adopting social media. The main reasons to join social media were as follows: staying connected with colleagues, reaching out and networking with the wider community, sharing knowledge, engaging in continued medical education, benchmarking, and branding. The main challenges of adopting social media by physicians were also as follows: maintaining confidentiality, lack of active participation, finding time, lack of trust, workplace acceptance and support, and information anarchy. By revealing the main benefits as well as the challenges of adopting social media by physicians, the study provides an opportunity for healthcare professionals to better understand the scope and impact of social media in healthcare, and assists them to adopt and harness social media effectively, and maximize the benefits for the specific needs of the clinical community. PMID:25038200

  8. Social media and physicians: Exploring the benefits and challenges.

    PubMed

    Panahi, Sirous; Watson, Jason; Partridge, Helen

    2016-06-01

    Healthcare professionals' use of social media platforms, such as blogs, wikis, and social networking web sites has grown considerably in recent years. However, few studies have explored the perspectives and experiences of physicians in adopting social media in healthcare. This article aims to identify the potential benefits and challenges of adopting social media by physicians and demonstrates this by presenting findings from a survey conducted with physicians. A qualitative survey design was employed to achieve the research goal. Semi-structured interviews were conducted with 24 physicians from around the world who were active users of social media. The data were analyzed using the thematic analysis approach. The study revealed six main reasons and six major challenges for physicians adopting social media. The main reasons to join social media were as follows: staying connected with colleagues, reaching out and networking with the wider community, sharing knowledge, engaging in continued medical education, benchmarking, and branding. The main challenges of adopting social media by physicians were also as follows: maintaining confidentiality, lack of active participation, finding time, lack of trust, workplace acceptance and support, and information anarchy. By revealing the main benefits as well as the challenges of adopting social media by physicians, the study provides an opportunity for healthcare professionals to better understand the scope and impact of social media in healthcare, and assists them to adopt and harness social media effectively, and maximize the benefits for the specific needs of the clinical community.

  9. Advanced clinical KCD scanner for digital radiography

    NASA Astrophysics Data System (ADS)

    DiBianca, Frank A.; Davis, Keana M.; Jordan, Lawrence M.; Laughter, Joseph S.; Krishnamurthy, Anand; Hu, Bo

    1998-07-01

    One of the goals of medical imaging scientists and bioengineers remains the development of digital electronic technologies that can replace film-based methods of acquiring x-ray images. With the achievement of this goal, all diagnostic imaging technologies would be based on digital techniques with all the attending benefits. Based on the performance of numerous research prototype small-field and one large-field Kinestatic Charge Detector (KCD) system for digital radiography, a large-field clinical KCD scanner is currently being designed and built for technical evaluation and for clinical evaluation of 200 volunteer patients (including clinical comparisons with film, storage phosphor, and other available clinical systems). The state of development of this clinical KCD system, including detector, data-acquisition system and scanning gantry design, is reviewed in this paper.

  10. General Achievement Trends: Oklahoma

    ERIC Educational Resources Information Center

    Center on Education Policy, 2009

    2009-01-01

    This general achievement trends profile includes information that the Center on Education Policy (CEP) and the Human Resources Research Organization (HumRRO) obtained from states from fall 2008 through April 2009. Included herein are: (1) Bullet points summarizing key findings about achievement trends in that state at three performance…

  11. General Achievement Trends: Georgia

    ERIC Educational Resources Information Center

    Center on Education Policy, 2009

    2009-01-01

    This general achievement trends profile includes information that the Center on Education Policy (CEP) and the Human Resources Research Organization (HumRRO) obtained from states from fall 2008 through April 2009. Included herein are: (1) Bullet points summarizing key findings about achievement trends in that state at three performance…

  12. General Achievement Trends: Nebraska

    ERIC Educational Resources Information Center

    Center on Education Policy, 2009

    2009-01-01

    This general achievement trends profile includes information that the Center on Education Policy (CEP) and the Human Resources Research Organization (HumRRO) obtained from states from fall 2008 through April 2009. Included herein are: (1) Bullet points summarizing key findings about achievement trends in that state at three performance…

  13. General Achievement Trends: Arkansas

    ERIC Educational Resources Information Center

    Center on Education Policy, 2009

    2009-01-01

    This general achievement trends profile includes information that the Center on Education Policy (CEP) and the Human Resources Research Organization (HumRRO) obtained from states from fall 2008 through April 2009. Included herein are: (1) Bullet points summarizing key findings about achievement trends in that state at three performance…

  14. General Achievement Trends: Maryland

    ERIC Educational Resources Information Center

    Center on Education Policy, 2009

    2009-01-01

    This general achievement trends profile includes information that the Center on Education Policy (CEP) and the Human Resources Research Organization (HumRRO) obtained from states from fall 2008 through April 2009. Included herein are: (1) Bullet points summarizing key findings about achievement trends in that state at three performance…

  15. General Achievement Trends: Maine

    ERIC Educational Resources Information Center

    Center on Education Policy, 2009

    2009-01-01

    This general achievement trends profile includes information that the Center on Education Policy (CEP) and the Human Resources Research Organization (HumRRO) obtained from states from fall 2008 through April 2009. Included herein are: (1) Bullet points summarizing key findings about achievement trends in that state at three performance…

  16. General Achievement Trends: Iowa

    ERIC Educational Resources Information Center

    Center on Education Policy, 2009

    2009-01-01

    This general achievement trends profile includes information that the Center on Education Policy (CEP) and the Human Resources Research Organization (HumRRO) obtained from states from fall 2008 through April 2009. Included herein are: (1) Bullet points summarizing key findings about achievement trends in that state at three performance…

  17. General Achievement Trends: Texas

    ERIC Educational Resources Information Center

    Center on Education Policy, 2009

    2009-01-01

    This general achievement trends profile includes information that the Center on Education Policy (CEP) and the Human Resources Research Organization (HumRRO) obtained from states from fall 2008 through April 2009. Included herein are: (1) Bullet points summarizing key findings about achievement trends in that state at three performance…

  18. General Achievement Trends: Hawaii

    ERIC Educational Resources Information Center

    Center on Education Policy, 2009

    2009-01-01

    This general achievement trends profile includes information that the Center on Education Policy (CEP) and the Human Resources Research Organization (HumRRO) obtained from states from fall 2008 through April 2009. Included herein are: (1) Bullet points summarizing key findings about achievement trends in that state at three performance…

  19. General Achievement Trends: Kansas

    ERIC Educational Resources Information Center

    Center on Education Policy, 2009

    2009-01-01

    This general achievement trends profile includes information that the Center on Education Policy (CEP) and the Human Resources Research Organization (HumRRO) obtained from states from fall 2008 through April 2009. Included herein are: (1) Bullet points summarizing key findings about achievement trends in that state at three performance…

  20. General Achievement Trends: Florida

    ERIC Educational Resources Information Center

    Center on Education Policy, 2009

    2009-01-01

    This general achievement trends profile includes information that the Center on Education Policy (CEP) and the Human Resources Research Organization (HumRRO) obtained from states from fall 2008 through April 2009. Included herein are: (1) Bullet points summarizing key findings about achievement trends in that state at three performance…

  1. General Achievement Trends: Massachusetts

    ERIC Educational Resources Information Center

    Center on Education Policy, 2009

    2009-01-01

    This general achievement trends profile includes information that the Center on Education Policy (CEP) and the Human Resources Research Organization (HumRRO) obtained from states from fall 2008 through April 2009. Included herein are: (1) Bullet points summarizing key findings about achievement trends in that state at three performance…

  2. General Achievement Trends: Tennessee

    ERIC Educational Resources Information Center

    Center on Education Policy, 2009

    2009-01-01

    This general achievement trends profile includes information that the Center on Education Policy (CEP) and the Human Resources Research Organization (HumRRO) obtained from states from fall 2008 through April 2009. Included herein are: (1) Bullet points summarizing key findings about achievement trends in that state at three performance…

  3. General Achievement Trends: Alabama

    ERIC Educational Resources Information Center

    Center on Education Policy, 2009

    2009-01-01

    This general achievement trends profile includes information that the Center on Education Policy (CEP) and the Human Resources Research Organization (HumRRO) obtained from states from fall 2008 through April 2009. Included herein are: (1) Bullet points summarizing key findings about achievement trends in that state at three performance…

  4. General Achievement Trends: Virginia

    ERIC Educational Resources Information Center

    Center on Education Policy, 2009

    2009-01-01

    This general achievement trends profile includes information that the Center on Education Policy (CEP) and the Human Resources Research Organization (HumRRO) obtained from states from fall 2008 through April 2009. Included herein are: (1) Bullet points summarizing key findings about achievement trends in that state at three performance…

  5. General Achievement Trends: Michigan

    ERIC Educational Resources Information Center

    Center on Education Policy, 2009

    2009-01-01

    This general achievement trends profile includes information that the Center on Education Policy (CEP) and the Human Resources Research Organization (HumRRO) obtained from states from fall 2008 through April 2009. Included herein are: (1) Bullet points summarizing key findings about achievement trends in that state at three performance…

  6. General Achievement Trends: Colorado

    ERIC Educational Resources Information Center

    Center on Education Policy, 2009

    2009-01-01

    This general achievement trends profile includes information that the Center on Education Policy (CEP) and the Human Resources Research Organization (HumRRO) obtained from states from fall 2008 through April 2009. Included herein are: (1) Bullet points summarizing key findings about achievement trends in that state at three performance…

  7. Inverting the Achievement Pyramid

    ERIC Educational Resources Information Center

    White-Hood, Marian; Shindel, Melissa

    2006-01-01

    Attempting to invert the pyramid to improve student achievement and increase all students' chances for success is not a new endeavor. For decades, educators have strategized, formed think tanks, and developed school improvement teams to find better ways to improve the achievement of all students. Currently, the No Child Left Behind Act (NCLB) is…

  8. Achievement Test Program.

    ERIC Educational Resources Information Center

    Ohio State Dept. of Education, Columbus. Trade and Industrial Education Service.

    The Ohio Trade and Industrial Education Achievement Test battery is comprised of seven basic achievement tests: Machine Trades, Automotive Mechanics, Basic Electricity, Basic Electronics, Mechanical Drafting, Printing, and Sheet Metal. The tests were developed by subject matter committees and specialists in testing and research. The Ohio Trade and…

  9. School Effects on Achievement.

    ERIC Educational Resources Information Center

    Nichols, Robert C.

    The New York State Education Department conducts a Pupil Evaluation Program (PEP) in which each year all third, sixth, and ninth grade students in the state are given a series of achievement tests in reading and mathematics. The data accumulated by the department includes achievement test scores, teacher characteristics, building and curriculum…

  10. Heritability of Creative Achievement

    ERIC Educational Resources Information Center

    Piffer, Davide; Hur, Yoon-Mi

    2014-01-01

    Although creative achievement is a subject of much attention to lay people, the origin of individual differences in creative accomplishments remain poorly understood. This study examined genetic and environmental influences on creative achievement in an adult sample of 338 twins (mean age = 26.3 years; SD = 6.6 years). Twins completed the Creative…

  11. Confronting the Achievement Gap

    ERIC Educational Resources Information Center

    Gardner, David

    2007-01-01

    This article talks about the large achievement gap between children of color and their white peers. The reasons for the achievement gap are varied. First, many urban minorities come from a background of poverty. One of the detrimental effects of growing up in poverty is receiving inadequate nourishment at a time when bodies and brains are rapidly…

  12. Achieving Public Schools

    ERIC Educational Resources Information Center

    Abowitz, Kathleen Knight

    2011-01-01

    Public schools are functionally provided through structural arrangements such as government funding, but public schools are achieved in substance, in part, through local governance. In this essay, Kathleen Knight Abowitz explains the bifocal nature of achieving public schools; that is, that schools are both subject to the unitary Public compact of…

  13. Benefits of Breastfeeding

    MedlinePlus

    ... size | Print | Skip left navigation It's Only Natural Planning ahead Breastfeeding and baby basics Making breastfeeding work for you Making the decision to breastfeed Secrets to breastfeeding success The benefits ...

  14. Power and sample size determination when assessing the clinical relevance of trial results by 'responder analyses'.

    PubMed

    Kieser, Meinhard; Röhmel, Joachim; Friede, Tim

    2004-11-15

    A fundamental issue in regulatory decision making is the assessment of the benefit/risk profile of a compound. In order to do this, establishing the existence of a treatment effect by a significance test is not sufficient, but the clinical relevance of a potential benefit must also be taken into account. A number of regulatory guidelines propose that clinical relevance should be assessed by considering the rate of responders, i.e. the proportion of patients who are observed to achieve an apparently meaningful benefit. In this paper, we present methods for planning clinical trials that aim at demonstrating both statistical and clinical significance in superiority trials. Procedures based on analytical calculations are derived for normally distributed data and the case of a single endpoint as well as multiple primary outcomes. A bootstrap procedure is proposed that can be applied to non-normal data. Application is illustrated by a clinical trial in Alzheimer's disease. PMID:15490433

  15. Student Achievement and Motivation

    ERIC Educational Resources Information Center

    Flammer, Gordon H.; Mecham, Robert C.

    1974-01-01

    Compares the lecture and self-paced methods of instruction on the basis of student motivation and achieveme nt, comparing motivating and demotivating factors in each, and their potential for motivation and achievement. (Authors/JR)

  16. Achieving TASAR Operational Readiness

    NASA Technical Reports Server (NTRS)

    Wing, David J.

    2015-01-01

    NASA has been developing and testing the Traffic Aware Strategic Aircrew Requests (TASAR) concept for aircraft operations featuring a NASA-developed cockpit automation tool, the Traffic Aware Planner (TAP), which computes traffic/hazard-compatible route changes to improve flight efficiency. The TAP technology is anticipated to save fuel and flight time and thereby provide immediate and pervasive benefits to the aircraft operator, as well as improving flight schedule compliance, passenger comfort, and pilot and controller workload. Previous work has indicated the potential for significant benefits for TASAR-equipped aircraft, and a flight trial of the TAP software application in the National Airspace System has demonstrated its technical viability. This paper reviews previous and ongoing activities to prepare TASAR for operational use.

  17. Cost benefit analysis of bovine mastitis in the UK.

    PubMed

    Beck, H S; Wise, W S; Dodd, F H

    1992-11-01

    Bovine mastitis reduces the yield and quality of milk and increases the rate of culling and veterinary costs. This reduces the profitability of farm milk production but the calculation of the extent of this economic loss is complex because of the many factors involved and deficiencies in the evidence on the relationship between the disease and various production factors. This paper examines the available evidence for the UK and provides a consistent analytical framework within which the benefits arising from reduced mastitis in dairy herds constrained by quota can be considered. It is estimated that since 1970 the farms that have followed the recommended control procedures have reduced the average annual number of cases of clinical mastitis from 135 to 40 cases/100 cows each year, while the quarters remaining uninfected for a whole year has increased from 65 to 80% of the total quarters. The costs of the main control procedures (e.g. 8.60 pounds/cow for dry-cow therapy and teat dipping or spraying) are broadly covered by the reduction in clinical mastitis, leaving the benefits of reduced subclinical infection (e.g. 3810 pounds for a 100 cow herd unconstrained by quota and achieving the average reduction in infection) as a substantial bonus. The imposition of quotas reduces the financial benefit of mastitis control but it still remains a worthwhile investment. The results of this analysis can be used to suggest maximum costs of additional new control measures produced by research. It also indicates that there is considerable value in production research which gives more precise knowledge of production systems, thus allowing producers to respond optimally to quota cuts.

  18. 20 CFR 416.1225 - An approved plan to achieve self-support; general.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... 20 Employees' Benefits 2 2013-04-01 2013-04-01 false An approved plan to achieve self-support; general. 416.1225 Section 416.1225 Employees' Benefits SOCIAL SECURITY ADMINISTRATION SUPPLEMENTAL... achieve self-support; general. If you are blind or disabled, we will pay you SSI benefits and will...

  19. Benefits of Required Counseling for Counseling Students

    ERIC Educational Resources Information Center

    Prosek, Elizabeth A.; Holm, Jessica M.; Daly, Cynthia M.

    2013-01-01

    Graduate students experience mental health distress. The authors investigated the benefits of required counseling services at a training clinic for students enrolled in counseling courses. Results indicated that after receiving services, students ("N" = 55) reported decreases in overall problems, depressive symptoms, and anxiety…

  20. Remote Ischemic Conditioning: Its Benefits and Limitations.

    PubMed

    Kloner, Robert A

    2016-03-01

    This editorial describes benefits and limitations of remote ischemic conditioning. Remote ischemic conditioning was shown to reduce myocardial intact size in at least 4 sizeable clinical trials of acute myocardial infarction. It was not effective in recent studies of cardiac surgery. Reasons for these differences are discussed.

  1. MAO inhibitors: risks, benefits, and lore.

    PubMed

    Wimbiscus, Molly; Kostenko, Olga; Malone, Donald

    2010-12-01

    Monoamine oxidase (MAO) inhibitors were the first antidepressants introduced, but their use has dwindled because of their reported side effects, their food and drug interactions, and the introduction of other classes of agents. However, interest in MAO inhibitors is reviving. Here, we discuss their use, risks, and benefits in clinical medicine.

  2. 38 CFR 71.40 - Caregiver benefits.

    Code of Federal Regulations, 2013 CFR

    2013-07-01

    ... provided through: (i) Online and in-person educational sessions. (ii) Use of telehealth and other available... monitoring will occur no less often than every 90 days, unless otherwise clinically indicated, and will... beneficiary travel under 38 CFR part 70. (c) Primary Family Caregiver benefits. VA will provide to...

  3. Intensive statin therapy for Indians: Part-I. Benefits.

    PubMed

    Enas, Enas A; Pazhoor, Hancy Chennikkara; Kuruvila, Arun; Vijayaraghavan, Krishnaswami

    2011-01-01

    The underlying disorder in the vast majority of cases of cardiovascular disease (CVD) is atherosclerosis, for which low-density lipoprotein cholesterol (LDL-C) is recognized as the first and foremost risk factor. HMG-CoA reductase inhibitors, popularly called statins, are highly effective and remarkably safe in reducing LDL-C and non-HDL-C levels. Evidence from clinical trials have demonstrated that statin therapy can reduce the risk of myocardial infarction (MI), stroke, death, and the need for coronary artery revascularization procedures (CARPs) by 25-50%, depending on the magnitude of LDL-C lowering achieved. Benefits are seen in men and women, young and old, and in people with and without diabetes or prior diagnosis of CVD. Clinical trials comparing standard statin therapy to intensive statin therapy have clearly demonstrated greater benefits in CVD risk reduction (including halting the progression and even reversing coronary atherosclerosis) without any corresponding increase in risk. Numerous outcome trials of intensive statin therapy using atorvastatin 80 mg/d have demonstrated the safety and the benefits of lowering LDL-C to very low levels. This led the USNCEP Guideline Committee to standardize 40 mg/dL as the optimum LDL-C level, above which the CVD risk begins to rise. Recent studies have shown intensive statin therapy can also lower CVD events even in low-risk individuals with LDL-C <110 mg/dL. Because of the heightened risk of CVD in Asian Indians, the LDL-C target is set at 30 mg/dL lower than that recommended by NCEP. Accordingly, the LDL-C goal is < 70 mg/dL for Indians who have CVD, diabetes, metabolic syndrome, or chronic kidney disease. Intensive statin therapy is often required in these populations as well as others who require a > or = 50% reduction in LDL-C. Broader acceptance of this lower LDL-C targets and its implementation could reduce the CVD burden in the Indian population by 50% in the next 25 years. Clinical trial data support an

  4. Teacher Retirement Benefits

    ERIC Educational Resources Information Center

    Costrell, Robert; Podgursky, Michael

    2009-01-01

    The ongoing global financial crisis is forcing many employers, from General Motors to local general stores, to take a hard look at the costs of the compensation packages they offer employees. For public school systems, this will entail a consideration of fringe benefit costs, which in recent years have become an increasingly important component of…

  5. The Benefits of Latin?

    ERIC Educational Resources Information Center

    Holliday, Lisa R.

    2012-01-01

    Classicists have long claimed that the study of Latin has benefits that exceed knowledge of the language itself, and in the current economic times, these claims are made with urgency. Indeed, many contend that Latin improves English grammar and writing skills, cognitive abilities, and develops transferable skills necessary for success in the…

  6. Benefits of Conducting Research.

    ERIC Educational Resources Information Center

    Anderson, Frances E.

    2001-01-01

    Metaphors for researchers, such as a crusader; a traveler; an explorer; a miner; an astronaut; a biblical Daniel; a Samurai; and an archaeologist are discussed. Benefits of conducting research are enumerated, including building the knowledge base for art therapy; increasing professional opportunities; improving client care; and advancing the…

  7. More Benefits of Automation.

    ERIC Educational Resources Information Center

    Getz, Malcolm

    1988-01-01

    Describes a study that measured the benefits of an automated catalog and automated circulation system from the library user's point of view in terms of the value of time saved. Topics discussed include patterns of use, access time, availability of information, search behaviors, and the effectiveness of the measures used. (seven references)…

  8. Space for Mankind's Benefit.

    ERIC Educational Resources Information Center

    von Puttkamer, Jesco, Ed.; McCullough, Thomas J., Ed.

    Presented are the proceedings of the first international Congress on "Space for Mankind's Benefit" organized by the Huntsville Association of Technical Societies and held November 15-19, 1971, at Huntsville, Alabama. Following introductory statements, a total of 45 articles read in 10 sessions are incorporated. The session headings are: Man in…

  9. Costs and benefits

    NASA Technical Reports Server (NTRS)

    1975-01-01

    Two models of cost benefit analysis are illustrated and the application of these models to assessing the economic scope of space applications programs was discussed. Four major areas cited as improvable through space derived information - food supply and distribution, energy sources, mineral reserves, and communication and navigation were - discussed. Specific illustrations are given for agriculture and maritime traffic.

  10. Inclusion: Who Really Benefits?

    ERIC Educational Resources Information Center

    Wilson-Younger, Dylinda

    2009-01-01

    Since the reauthorization of 2003, schools across the nation are mandated to educate students within the regular educational environment. What impact does this merger have on students and teachers? Who really benefits from this merger of regular education and special education? This article discusses the attitudes of general education teachers…

  11. Iowa Women of Achievement.

    ERIC Educational Resources Information Center

    Ohrn, Deborah Gore, Ed.

    1993-01-01

    This issue of the Goldfinch highlights some of Iowa's 20th century women of achievement. These women have devoted their lives to working for human rights, education, equality, and individual rights. They come from the worlds of politics, art, music, education, sports, business, entertainment, and social work. They represent Native Americans,…

  12. Achieving Peace through Education.

    ERIC Educational Resources Information Center

    Clarken, Rodney H.

    While it is generally agreed that peace is desirable, there are barriers to achieving a peaceful world. These barriers are classified into three major areas: (1) an erroneous view of human nature; (2) injustice; and (3) fear of world unity. In a discussion of these barriers, it is noted that although the consciousness and conscience of the world…

  13. Increasing Male Academic Achievement

    ERIC Educational Resources Information Center

    Jackson, Barbara Talbert

    2008-01-01

    The No Child Left Behind legislation has brought greater attention to the academic performance of American youth. Its emphasis on student achievement requires a closer analysis of assessment data by school districts. To address the findings, educators must seek strategies to remedy failing results. In a mid-Atlantic district of the Unites States,…

  14. Leadership Issues: Raising Achievement.

    ERIC Educational Resources Information Center

    Horsfall, Chris, Ed.

    This document contains five papers examining the meaning and operation of leadership as a variable affecting student achievement in further education colleges in the United Kingdom. "Introduction" (Chris Horsfall) discusses school effectiveness studies' findings regarding the relationship between leadership and effective schools, distinguishes…

  15. Achievements or Disasters?

    ERIC Educational Resources Information Center

    Goodwin, MacArthur

    2000-01-01

    Focuses on policy issues that have affected arts education in the twentieth century, such as: interest in discipline-based arts education, influence of national arts associations, and national standards and coordinated assessment. States that whether the policy decisions are viewed as achievements or disasters are for future determination. (CMK)

  16. Achieving True Consensus.

    ERIC Educational Resources Information Center

    Napier, Rod; Sanaghan, Patrick

    2002-01-01

    Uses the example of Vermont's Middlebury College to explore the challenges and possibilities of achieving consensus about institutional change. Discusses why, unlike in this example, consensus usually fails, and presents four demands of an effective consensus process. Includes a list of "test" questions on successful collaboration. (EV)

  17. School Students' Science Achievement

    ERIC Educational Resources Information Center

    Shymansky, James; Wang, Tzu-Ling; Annetta, Leonard; Everett, Susan; Yore, Larry D.

    2013-01-01

    This paper is a report of the impact of an externally funded, multiyear systemic reform project on students' science achievement on a modified version of the Third International Mathematics and Science Study (TIMSS) test in 33 small, rural school districts in two Midwest states. The systemic reform effort utilized a cascading leadership strategy…

  18. Essays on Educational Achievement

    ERIC Educational Resources Information Center

    Ampaabeng, Samuel Kofi

    2013-01-01

    This dissertation examines the determinants of student outcomes--achievement, attainment, occupational choices and earnings--in three different contexts. The first two chapters focus on Ghana while the final chapter focuses on the US state of Massachusetts. In the first chapter, I exploit the incidence of famine and malnutrition that resulted to…

  19. Assessing Handwriting Achievement.

    ERIC Educational Resources Information Center

    Ediger, Marlow

    Teachers in the school setting need to emphasize quality handwriting across the curriculum. Quality handwriting means that the written content is easy to read in either manuscript or cursive form. Handwriting achievement can be assessed, but not compared to the precision of assessing basic addition, subtraction, multiplication, and division facts.…

  20. Intelligence and Educational Achievement

    ERIC Educational Resources Information Center

    Deary, Ian J.; Strand, Steve; Smith, Pauline; Fernandes, Cres

    2007-01-01

    This 5-year prospective longitudinal study of 70,000+ English children examined the association between psychometric intelligence at age 11 years and educational achievement in national examinations in 25 academic subjects at age 16. The correlation between a latent intelligence trait (Spearman's "g"from CAT2E) and a latent trait of educational…

  1. Explorations in achievement motivation

    NASA Technical Reports Server (NTRS)

    Helmreich, Robert L.

    1982-01-01

    Recent research on the nature of achievement motivation is reviewed. A three-factor model of intrinsic motives is presented and related to various criteria of performance, job satisfaction and leisure activities. The relationships between intrinsic and extrinsic motives are discussed. Needed areas for future research are described.

  2. NCLB: Achievement Robin Hood?

    ERIC Educational Resources Information Center

    Bracey, Gerald W.

    2008-01-01

    In his "Wall Street Journal" op-ed on the 25th of anniversary of "A Nation At Risk", former assistant secretary of education Chester E. Finn Jr. applauded the report for turning U.S. education away from equality and toward achievement. It was not surprising, then, that in mid-2008, Finn arranged a conference to examine the potential "Robin Hood…

  3. Achieving All Our Ambitions

    ERIC Educational Resources Information Center

    Hartley, Tricia

    2009-01-01

    National learning and skills policy aims both to build economic prosperity and to achieve social justice. Participation in higher education (HE) has the potential to contribute substantially to both aims. That is why the Campaign for Learning has supported the ambition to increase the proportion of the working-age population with a Level 4…

  4. INTELLIGENCE, PERSONALITY AND ACHIEVEMENT.

    ERIC Educational Resources Information Center

    MUIR, R.C.; AND OTHERS

    A LONGITUDINAL DEVELOPMENTAL STUDY OF A GROUP OF MIDDLE CLASS CHILDREN IS DESCRIBED, WITH EMPHASIS ON A SEGMENT OF THE RESEARCH INVESTIGATING THE RELATIONSHIP OF ACHIEVEMENT, INTELLIGENCE, AND EMOTIONAL DISTURBANCE. THE SUBJECTS WERE 105 CHILDREN AGED FIVE TO 6.3 ATTENDING TWO SCHOOLS IN MONTREAL. EACH CHILD WAS ASSESSED IN THE AREAS OF…

  5. SALT and Spelling Achievement.

    ERIC Educational Resources Information Center

    Nelson, Joan

    A study investigated the effects of suggestopedic accelerative learning and teaching (SALT) on the spelling achievement, attitudes toward school, and memory skills of fourth-grade students. Subjects were 20 male and 28 female students from two self-contained classrooms at Kennedy Elementary School in Rexburg, Idaho. The control classroom and the…

  6. Appraising Reading Achievement.

    ERIC Educational Resources Information Center

    Ediger, Marlow

    To determine quality sequence in pupil progress, evaluation approaches need to be used which guide the teacher to assist learners to attain optimally. Teachers must use a variety of procedures to appraise student achievement in reading, because no one approach is adequate. Appraisal approaches might include: (1) observation and subsequent…

  7. Motivation and academic achievement in medical students

    PubMed Central

    Yousefy, Alireza; Ghassemi, Gholamreza; Firouznia, Samaneh

    2012-01-01

    Background: Despite their ascribed intellectual ability and achieved academic pursuits, medical students’ academic achievement is influenced by motivation. This study is an endeavor to examine the role of motivation in the academic achievement of medical students. Materials and Methods: In this cross-sectional correlational study, out of the total 422 medical students, from 4th to final year during the academic year 2007–2008, at School of Medicine, Isfahan University of Medical Sciences, 344 participated in completion of the Inventory of School Motivation (ISM), comprising 43 items and measuring eight aspects of motivation. The gold standard for academic achievement was their average academic marks at pre-clinical and clinical levels. Data were computer analyzed by running a couple of descriptive and analytical tests including Pearson Correlation and Student's t-student. Results: Higher motivation scores in areas of competition, effort, social concern, and task were accompanied by higher average marks at pre-clinical as well as clinical levels. However, the latter ones showed greater motivation for social power as compared to the former group. Task and competition motivation for boys was higher than for girls. Conclusion: In view of our observations, students’ academic achievement requires coordination and interaction between different aspects of motivation. PMID:23555107

  8. Capturing patient benefits of treatment.

    PubMed

    Carr, Alan; Wolfaardt, John; Garrett, Neal

    2011-01-01

    Findings from the Academy of Osseointegration State of the Science on Implant Dentistry Conference clearly demonstrate that data are lacking regarding both quality of design and adequate outcome measures (standardization, validity, and relevance to patient) to support an evidence-based systematic evaluation of implant efficacy. Despite the dearth of controlled trials and the variability in defining implant survival/success, the preponderance of evidence is viewed as lending support for consideration of dental implant therapy as a safe and predictable alternative to conventional restorations for many applications. However, this minimal conclusion undermines the best intentions of the dental profession, which is striving to substantiate to the patient, third-party providers, and the government the relative benefits and risks of various prosthetic treatment alternatives. The conclusions of multiple consensus conferences have repeatedly stressed that additional research with good strength of evidence following a broad spectrum of outcomes is vital to extend the breadth of conclusions regarding dental implant treatment efficacy. However, without a set of consensus-based core outcome measures addressing pertinent clinical and patient-centered factors, future expensive, time-consuming, and technically complex clinical studies may suffer the same critical flaws seen in the current body of research. It may be possible and useful to establish a core set of well-defined, discriminatory, and feasible outcome measures for common utilization and a hierarchy of additional recommended outcome measures for specific benefit categories. Such a standardized group of outcome measures would be likely to significantly enhance the potential for future research. In addition, with the formation of consensus guidelines, there would be an opportunity for scientific journals to promote the quality of implant dentistry research by suggesting the inclusion of these core outcome measures in

  9. Quantifying the costs and benefits of occupational health and safety interventions at a Bangladesh shipbuilding company

    PubMed Central

    Thiede, Irene; Thiede, Michael

    2015-01-01

    Background: This study is the first cost–benefit analysis (CBA) of occupational health and safety (OHS) in a low-income country. It focuses on one of the largest shipbuilding companies in Bangladesh, where globally recognised Occupational Health and Safety Advisory Services (OHSAS) 18001 certification was achieved in 2012. Objectives: The study examines the relative costs of implementing OHS measures against qualitative and quantifiable benefits of implementation in order to determine whether OHSAS measures are economically advantageous. Methods: Quantifying past costs and benefits and discounting future ones, this study looks at the returns of OHS measures at Western Marine Shipbuilding Company Ltd. Results: Costs included investments in workplace and environmental safety, a new clinic that also serves the community, and personal protective equipment (PPE) and training. The results are impressive: previously high injury statistics dropped to close to zero. Conclusions: OHS measures decrease injuries, increase efficiency, and bring income security to workers’ families. Certification has proven a competitive edge for the shipyard, resulting in access to greater markets. Intangible benefits such as trust, motivation and security are deemed crucial in the CBA, and this study finds the high investments made are difficult to offset with quantifiable benefits alone. PMID:25589369

  10. University Benefits Survey. Part I (All Benefits Excluding Pensions).

    ERIC Educational Resources Information Center

    University of Western Ontario, London.

    Results of a 1984 survey of benefits, excluding pensions, for 17 Ontario, Canada, universities are presented. Information is provided on the following areas: questions on general benefits, such as insurance plans, communication of benefits, proposed changes in benefits, provision of life and dismemberment insurance, and maternity leave policy;…

  11. University Benefits Survey: Part I (All Benefits Excluding Pensions).

    ERIC Educational Resources Information Center

    University of Western Ontario, London.

    Information on all benefits, excluding pensions, provided by 16 Ontario universities is presented. The following general questions concerning benefits are covered: administration and insurance plans, communication of benefit programs to employees, proposed changes in benefits, provision of life and dismemberment insurance, and maternity leave…

  12. Project ACHIEVE final report

    SciTech Connect

    1997-06-13

    Project ACHIEVE was a math/science academic enhancement program aimed at first year high school Hispanic American students. Four high schools -- two in El Paso, Texas and two in Bakersfield, California -- participated in this Department of Energy-funded program during the spring and summer of 1996. Over 50 students, many of whom felt they were facing a nightmare future, were given the opportunity to work closely with personal computers and software, sophisticated calculators, and computer-based laboratories -- an experience which their regular academic curriculum did not provide. Math and science projects, exercises, and experiments were completed that emphasized independent and creative applications of scientific and mathematical theories to real world problems. The most important outcome was the exposure Project ACHIEVE provided to students concerning the college and technical-field career possibilities available to them.

  13. [Let Us to Know the Post-Marketing Clinical Studies and Critical Situation of Study Groups -- Now We Should Talk about How to Achieve the Safe and Most Effective Treatment for Cancer Patients].

    PubMed

    Hamamoto, Maki

    2016-04-01

    Not to leave something to be regretted in the life of patients and their family, it is important to find the best way during and after treatment for cancer. We, cancer survivors association, propose a corporated actions among patients, administration, medical stuffs, and enterprises to solve the problems of clinical studies. And we express our opinion on the present problems and to do for patients and citizens. PMID:27220802

  14. [Let Us to Know the Post-Marketing Clinical Studies and Critical Situation of Study Groups -- Now We Should Talk about How to Achieve the Safe and Most Effective Treatment for Cancer Patients].

    PubMed

    Hamamoto, Maki

    2016-04-01

    Not to leave something to be regretted in the life of patients and their family, it is important to find the best way during and after treatment for cancer. We, cancer survivors association, propose a corporated actions among patients, administration, medical stuffs, and enterprises to solve the problems of clinical studies. And we express our opinion on the present problems and to do for patients and citizens.

  15. Expected benefits of federally-funded thermal energy storage research

    NASA Astrophysics Data System (ADS)

    Spanner, G. E.; Daellenbach, K. K.; Hughes, K. R.; Brown, D. R.; Drost, M. K.

    1992-09-01

    Pacific Northwest Laboratory (PNL) conducted this study for the Office of Advanced Utility Concepts of the US Department of Energy (DOE). The objective of this study was to develop a series of graphs that depict the long-term benefits of continuing DOE's thermal energy storage (TES) research program in four sectors: building heating, building cooling, utility power production, and transportation. The study was conducted in three steps. The first step was to assess the maximum possible benefits technically achievable in each sector. In some sectors, the maximum benefit was determined by a 'supply side' limitation, and in other sectors, the maximum benefit is determined by a 'demand side' limitation. The second step was to apply economic cost and diffusion models to estimate the benefits that are likely to be achieved by TES under two scenarios: (1) with continuing DOE funding of TES research; and (2) without continued funding. The models all cover the 20-year period from 1990 to 2010. The third step was to prepare graphs that show the maximum technical benefits achievable, the estimated benefits with TES research funding, and the estimated benefits in the absence of TES research funding. The benefits of federally-funded TES research are largely in four areas: displacement of primary energy, displacement of oil and natural gas, reduction in peak electric loads, and emissions reductions.

  16. Expected benefits of federally-funded thermal energy storage research

    SciTech Connect

    Spanner, G.E.; Daellenbach, K.K.; Hughes, K.R.; Brown, D.R.; Drost, M.K.

    1992-09-01

    Pacific Northwest Laboratory (PNL) conducted this study for the Office of Advanced Utility Concepts of the US Department of Energy (DOE). The objective of this study was to develop a series of graphs that depict the long-term benefits of continuing DOE`s thermal energy storage (TES) research program in four sectors: building heating, building cooling, utility power production, and transportation. The study was conducted in three steps- The first step was to assess the maximum possible benefits technically achievable in each sector. In some sectors, the maximum benefit was determined by a ``supply side`` limitation, and in other sectors, the maximum benefit is determined by a ``demand side`` limitation. The second step was to apply economic cost and diffusion models to estimate the benefits that are likely to be achieved by TES under two scenarios: (1) with continuing DOE funding of TES research, and (2) without continued funding. The models all cover the 20-year period from 1990 to 2010. The third step was to prepare graphs that show the maximum technical benefits achievable, the estimated benefits with TES research funding, and the estimated benefits in the absence of TES research funding. The benefits of federally-funded TES research are largely in four areas: displacement of primary energy, displacement of oil and natural gas, reduction in peak electric loads, and emissions reductions.

  17. Does achievement motivation mediate the semantic achievement priming effect?

    PubMed

    Engeser, Stefan; Baumann, Nicola

    2014-10-01

    The aim of our research was to understand the processes of the prime-to-behavior effects with semantic achievement primes. We extended existing models with a perspective from achievement motivation theory and additionally used achievement primes embedded in the running text of excerpts of school textbooks to simulate a more natural priming condition. Specifically, we proposed that achievement primes affect implicit achievement motivation and conducted pilot experiments and 3 main experiments to explore this proposition. We found no reliable positive effect of achievement primes on implicit achievement motivation. In light of these findings, we tested whether explicit (instead of implicit) achievement motivation is affected by achievement primes and found this to be the case. In the final experiment, we found support for the assumption that higher explicit achievement motivation implies that achievement priming affects the outcome expectations. The implications of the results are discussed, and we conclude that primes affect achievement behavior by heightening explicit achievement motivation and outcome expectancies. PMID:24820250

  18. Updates and achievements in virology.

    PubMed

    Buonaguro, Franco M; Campadelli-Fiume, Gabriella; De Giuli Morghen, Carlo; Palù, Giorgio

    2010-07-01

    The 4th European Congress of Virology, hosted by the Italian Society for Virology, attracted approximately 1300 scientists from 46 countries worldwide. It also represented the first conference of the European Society for Virology, which was established in Campidoglio, Rome, Italy in 2009. The main goal of the meeting was to share research activities and results achieved in European virology units/institutes and to strengthen collaboration with colleagues from both western and developing countries. The worldwide representation of participants is a testament to the strength and attraction of European virology. The 5-day conference brought together the best of current virology; topics covered all three living domains (bacteria, archaea and eucarya), with special sessions on plant and veterinary virology as well as human virology, including two oral presentations on mimiviruses. The conference included five plenary sessions, 31 workshops, one hepatitis C virus roundtable, ten special workshops and three poster sessions, as well as 45 keynote lectures, 191 oral presentations and 845 abstracts. Furthermore, the Gesellschaft fur Virologie Loeffler-Frosch medal award was given to Peter Vogt for his long-standing career and achievements; the Gardner Lecture of the European Society for Clinical Virology was presented by Yoshihiro Kawaoka, and the Pioneer in Virology Lecture of the Italian Society for Virology was presented by Ulrich Koszinowski.

  19. Spotlight on lasers. A look at potential benefits

    SciTech Connect

    Zakariasen, K.L.; MacDonald, R.; Boran, T. )

    1991-07-01

    Before lasers can be highly integrated into clinical practice, further research must prove the efficacy, efficiency, consistency and safety of this new technology. Currently, increased caries prevention and rapid laser etching are two potential benefits of laser technology.

  20. Maximizing the benefits of antiretroviral therapy for key affected populations

    PubMed Central

    Grubb, Ian R; Beckham, Sarah W; Kazatchkine, Michel; Thomas, Ruth M; Albers, Eliot R; Cabral, Mauro; Lange, Joep; Vella, Stefano; Kurian, Manoj; Beyrer, Chris

    2014-01-01

    Introduction Scientific research has demonstrated the clinical benefits of earlier initiation of antiretroviral treatment (ART), and that ART can markedly reduce HIV transmission to sexual partners. Ensuring universal access to ART for those who need it has long been a core principle of the HIV response, and extending the benefits of ART to key populations is critical to increasing the impact of ART and the overall effectiveness of the HIV response. However, this can only be achieved through coordinated efforts to address political, social, legal and economic barriers that key populations face in accessing HIV services. Discussion Recent analyses show that HIV prevalence levels among key populations are far higher than among the general population, and they experience a range of biological and behavioural factors, and social, legal and economic barriers that increase their vulnerability to HIV and have resulted in alarmingly low ART coverage. World Health Organization 2014 consolidated guidance on HIV among key populations offers the potential for increased access to ART by key populations, following the same principles as for the general adult population. However, it should not be assumed that key populations will achieve greater access to ART unless stigma, discrimination and punitive laws, policies and practices that limit access to ART and other HIV interventions in many countries are addressed. Conclusions Rights-based approaches and investments in critical enablers, such as supportive legal and policy environments, are essential to enable wider access to ART and other HIV interventions for key populations. The primary objective of ART should always be to treat the person living with HIV; prevention is an important, additional benefit. ART should be provided only with informed consent. The preventive benefits of treatment must not be used as a pretext for failure to provide other necessary HIV programming for key populations, including comprehensive harm

  1. Past, present, and future of radiotherapy for the benefit of patients.

    PubMed

    Thariat, Juliette; Hannoun-Levi, Jean-Michel; Sun Myint, Arthur; Vuong, Te; Gérard, Jean-Pierre

    2013-01-01

    Radiotherapy has been driven by constant technological advances since the discovery of X-rays in 1895. Radiotherapy aims to sculpt the optimal isodose on the tumour volume while sparing normal tissues. The benefits are threefold: patient cure, organ preservation and cost-efficiency. The efficacy and tolerance of radiotherapy were demonstrated by randomized trials in many different types of cancer (including breast, prostate and rectum) with a high level of scientific evidence. Such achievements, of major importance for the quality of life of patients, have been fostered during the past decade by linear accelerators with computer-assisted technology. More recently, these developments were augmented by proton and particle beam radiotherapy, usually combined with surgery and medical treatment in a multidisciplinary and personalized strategy against cancer. This article reviews the timeline of 100 years of radiotherapy with a focus on breakthroughs in the physics of radiotherapy and technology during the past two decades, and the associated clinical benefits.

  2. The principles of quality-associated costing: derivation from clinical transfusion practice.

    PubMed

    Trenchard, P M; Dixon, R

    1997-01-01

    As clinical transfusion practice works towards achieving cost-effectiveness, prescribers of blood and its derivatives must be certain that the prices of such products are based on real manufacturing costs and not market forces. Using clinical cost-benefit analysis as the context for the costing and pricing of blood products, this article identifies the following two principles: (1) the product price must equal the product cost (the "price = cost" rule) and (2) the product cost must equal the real cost of product manufacture. In addition, the article describes a new method of blood product costing, quality-associated costing (QAC), that will enable valid cost-benefit analysis of blood products.

  3. Learn about Clinical Studies

    MedlinePlus

    ... in the care of future patients by providing information about the benefits and risks of therapeutic, preventative, or diagnostic products or interventions. Clinical trials provide the basis for the development and marketing of new drugs, biological products, and medical devices. ...

  4. Green tea and theanine: health benefits.

    PubMed

    Cooper, Raymond

    2012-03-01

    Historically, the medicinal use of green tea dates back to China 4700 years ago and drinking tea continues to be regarded traditionally in Asia as a general healthful practice. Numerous scientific publications now attest to the health benefits of both black and green teas, including clinical and epidemiological studies. Although all tea contains beneficial antioxidants, high-quality green and white teas have them in greater concentrations than black tea. Today, scientists believe that the main active ingredients of green tea include the polyphenols, in particular the catechins and the amino acid, theanine. Studies on the health benefits of drinking tea, particularly green tea, are finding exciting results, particularly in cancer research. Modern studies in both Asia and the West have provided encouraging results indicating that drinking green tea contributes to fighting many different kinds of cancers including stomach, oesophageal, ovarian and colon. Recent studies describing the health benefits of these compounds will be reviewed.

  5. The benefit of forgetting.

    PubMed

    Williams, Melonie; Hong, Sang W; Kang, Min-Suk; Carlisle, Nancy B; Woodman, Geoffrey F

    2013-04-01

    Recent research using change-detection tasks has shown that a directed-forgetting cue, indicating that a subset of the information stored in memory can be forgotten, significantly benefits the other information stored in visual working memory. How do these directed-forgetting cues aid the memory representations that are retained? We addressed this question in the present study by using a recall paradigm to measure the nature of the retained memory representations. Our results demonstrated that a directed-forgetting cue leads to higher-fidelity representations of the remaining items and a lower probability of dropping these representations from memory. Next, we showed that this is made possible by the to-be-forgotten item being expelled from visual working memory following the cue, allowing maintenance mechanisms to be focused on only the items that remain in visual working memory. Thus, the present findings show that cues to forget benefit the remaining information in visual working memory by fundamentally improving their quality relative to conditions in which just as many items are encoded but no cue is provided. PMID:23208769

  6. Achieving closure at Fernald

    SciTech Connect

    Bradburne, John; Patton, Tisha C.

    2001-02-25

    When Fluor Fernald took over the management of the Fernald Environmental Management Project in 1992, the estimated closure date of the site was more than 25 years into the future. Fluor Fernald, in conjunction with DOE-Fernald, introduced the Accelerated Cleanup Plan, which was designed to substantially shorten that schedule and save taxpayers more than $3 billion. The management of Fluor Fernald believes there are three fundamental concerns that must be addressed by any contractor hoping to achieve closure of a site within the DOE complex. They are relationship management, resource management and contract management. Relationship management refers to the interaction between the site and local residents, regulators, union leadership, the workforce at large, the media, and any other interested stakeholder groups. Resource management is of course related to the effective administration of the site knowledge base and the skills of the workforce, the attraction and retention of qualified a nd competent technical personnel, and the best recognition and use of appropriate new technologies. Perhaps most importantly, resource management must also include a plan for survival in a flat-funding environment. Lastly, creative and disciplined contract management will be essential to effecting the closure of any DOE site. Fluor Fernald, together with DOE-Fernald, is breaking new ground in the closure arena, and ''business as usual'' has become a thing of the past. How Fluor Fernald has managed its work at the site over the last eight years, and how it will manage the new site closure contract in the future, will be an integral part of achieving successful closure at Fernald.

  7. University Benefits Survey. Part I (All Benefits Excluding Pensions).

    ERIC Educational Resources Information Center

    University of Western Ontario, London.

    Results of a 1985 survey of benefits, excluding pensions, for 17 Ontario, Canada, universities are presented. Information is provided on the following areas: whether the university self-administers insurance plans, communication of information on benefits, proposed changes in benefits, provision of accidental death and dismemberment insurance,…

  8. University Benefits Survey. Part 1 (All Benefits Excluding Pensions).

    ERIC Educational Resources Information Center

    University of Western Ontario, London.

    Results of a 1983 survey of benefits, excluding pensions, for 17 Ontario, Canada, universities are presented. Information is provided on the following areas: whether the university self-administers insurance plans, communication of benefits, proposed changes in benefits, provision of life and dismemberment insurance, maternity leave policy,…

  9. University Benefits Survey, Part I (All Benefits Excluding Pensions).

    ERIC Educational Resources Information Center

    University of Western Ontario, London.

    The results of a survey of benefits, excluding pensions, for 17 Ontario, Canada, universities are presented. Information is provided on the following areas: whether the university self-administers insurance plans, communication of benefits, proposed changes in benefits, provision of life and dismemberment insurance, maternity leave policy, Ontario…

  10. University Benefits Survey. Part I (All Benefits Excluding Pensions).

    ERIC Educational Resources Information Center

    University of Western Ontario, London.

    Results of a 1986 survey of benefits, excluding pensions, for 17 Ontario, Canada, universities are presented. Information is provided on the following areas: whether the university self- administers insurance plans, communication of benefits, proposed changes in benefits, provision of accidental death and dismemberment insurance, maternity leave…

  11. [How relevant are the benefits for participation at working life for psychosomatic inpatient rehabilitation].

    PubMed

    Kobelt, Axel; Grosch, Eberhard Virtus; Gutenbrunner, Christoph

    2006-01-01

    Beside the stabilization of the health status the reintegration into employment are the main ambitions of the medical rehabilitation. Thereby occupational rehabilitation plays an important role in the rehabilitation system. To recommend occupational rehabilitation physicians have to know the requirements patients have to comply with. In addition formal conditions of the medical report upon discharge have to be accomplish that benefits for participation at working life will be provided by the pension insurance. In our study the differences of the amount of recommendation for occupational rehabilitation and the appraisal of the ability to work in the medical reports upon discharge of psychosomatic and orthopaedic patients are examined. The results show that psychosomatic patients achieved significantly less recommendations for occupational rehabilitation than orthopaedic patients. At the same time more psychosomatic patients who achieved the recommendation didn't claim benefits for participation at working life. In addition orthopaedic patients get a rehabilitation approval certification more often than psychosomatic patients. At the same time it appears that maybe the recommending clinics were insecure about the connection between the occupational capacity assessment and the recommendations for benefits for participation at work life. The outcomes presume that work place problems in medical rehabilitation are not taken into consideration adequately.

  12. Achievement Goals and Achievement Emotions: A Meta-Analysis

    ERIC Educational Resources Information Center

    Huang, Chiungjung

    2011-01-01

    This meta-analysis synthesized 93 independent samples (N = 30,003) in 77 studies that reported in 78 articles examining correlations between achievement goals and achievement emotions. Achievement goals were meaningfully associated with different achievement emotions. The correlations of mastery and mastery approach goals with positive achievement…

  13. Insulin pump risks and benefits: a clinical appraisal of pump safety standards, adverse event reporting and research needs. A joint statement of the European Association for the Study of Diabetes and the American Diabetes Association Diabetes Technology Working Group.

    PubMed

    Heinemann, Lutz; Fleming, G Alexander; Petrie, John R; Holl, Reinhard W; Bergenstal, Richard M; Peters, Anne L

    2015-05-01

    Insulin pump therapy, also known as continuous subcutaneous insulin infusion (CSII), is an important and evolving form of insulin delivery, which is mainly used for people with type 1 diabetes. However, even with modern insulin pumps, errors of insulin infusion can occur due to pump failure, insulin infusion set (IIS) blockage, infusion site problems, insulin stability issues, user error or a combination of these. Users are therefore exposed to significant and potentially fatal hazards: interruption of insulin infusion can result in hyperglycaemia and ketoacidosis; conversely, delivery of excessive insulin can cause severe hypoglycaemia. Nevertheless, the available evidence on the safety and efficacy of CSII remains limited. The European Association for the Study of Diabetes (EASD) and American Diabetes Association (ADA) have therefore joined forces to review the systems in place for evaluating the safety of pumps from a clinical perspective. We found that useful information held by the manufacturing companies is not currently shared in a sufficiently transparent manner. Public availability of adverse event (AE) reports on the US Food and Drug Administration's Manufacturer and User Facility Device Experience (MAUDE) database is potentially a rich source of safety information but is insufficiently utilised due to the current configuration of the system; the comparable database in Europe (European Databank on Medical Devices, EUDAMED) is not publicly accessible. Many AEs appear to be attributable to human factors and/or user error, but the extent to which manufacturing companies are required by regulators to consider the interactions of users with the technical features of their products is limited. The clinical studies required by regulators prior to marketing are small and over-reliant on bench testing in relation to 'predicate' products. Once a pump is available on the market, insufficient data are made publicly available on its long-term use in a real

  14. Insulin pump risks and benefits: a clinical appraisal of pump safety standards, adverse event reporting, and research needs: a joint statement of the European Association for the Study of Diabetes and the American Diabetes Association Diabetes Technology Working Group.

    PubMed

    Heinemann, Lutz; Fleming, G Alexander; Petrie, John R; Holl, Reinhard W; Bergenstal, Richard M; Peters, Anne L

    2015-04-01

    Insulin pump therapy, also known as continuous subcutaneous insulin infusion (CSII), is an important and evolving form of insulin delivery, which is mainly used for people with type 1 diabetes. However, even with modern insulin pumps, errors of insulin infusion can occur due to pump failure, insulin infusion set (IIS) blockage, infusion site problems, insulin stability issues, user error, or a combination of these. Users are therefore exposed to significant and potentially fatal hazards: interruption of insulin infusion can result in hyperglycemia and ketoacidosis; conversely, delivery of excessive insulin can cause severe hypoglycemia. Nevertheless, the available evidence on the safety and efficacy of CSII remains limited. The European Association for the Study of Diabetes (EASD) and the American Diabetes Association (ADA) have therefore joined forces to review the systems in place for evaluating the safety of pumps from a clinical perspective. We found that useful information held by the manufacturing companies is not currently shared in a sufficiently transparent manner. Public availability of adverse event (AE) reports on the US Food and Drug Administration's Manufacturer and User Facility Device Experience (MAUDE) database is potentially a rich source of safety information but is insufficiently utilized due to the current configuration of the system; the comparable database in Europe (European Databank on Medical Devices [EUDAMED]) is not publicly accessible. Many AEs appear to be attributable to human factors and/or user error, but the extent to which manufacturing companies are required by regulators to consider the interactions of users with the technical features of their products is limited. The clinical studies required by regulators prior to marketing are small and over-reliant on bench testing in relation to "predicate" products. Once a pump is available on the market, insufficient data are made publicly available on its long-term use in a real

  15. Insulin pump risks and benefits: a clinical appraisal of pump safety standards, adverse event reporting, and research needs: a joint statement of the European Association for the Study of Diabetes and the American Diabetes Association Diabetes Technology Working Group.

    PubMed

    Heinemann, Lutz; Fleming, G Alexander; Petrie, John R; Holl, Reinhard W; Bergenstal, Richard M; Peters, Anne L

    2015-04-01

    Insulin pump therapy, also known as continuous subcutaneous insulin infusion (CSII), is an important and evolving form of insulin delivery, which is mainly used for people with type 1 diabetes. However, even with modern insulin pumps, errors of insulin infusion can occur due to pump failure, insulin infusion set (IIS) blockage, infusion site problems, insulin stability issues, user error, or a combination of these. Users are therefore exposed to significant and potentially fatal hazards: interruption of insulin infusion can result in hyperglycemia and ketoacidosis; conversely, delivery of excessive insulin can cause severe hypoglycemia. Nevertheless, the available evidence on the safety and efficacy of CSII remains limited. The European Association for the Study of Diabetes (EASD) and the American Diabetes Association (ADA) have therefore joined forces to review the systems in place for evaluating the safety of pumps from a clinical perspective. We found that useful information held by the manufacturing companies is not currently shared in a sufficiently transparent manner. Public availability of adverse event (AE) reports on the US Food and Drug Administration's Manufacturer and User Facility Device Experience (MAUDE) database is potentially a rich source of safety information but is insufficiently utilized due to the current configuration of the system; the comparable database in Europe (European Databank on Medical Devices [EUDAMED]) is not publicly accessible. Many AEs appear to be attributable to human factors and/or user error, but the extent to which manufacturing companies are required by regulators to consider the interactions of users with the technical features of their products is limited. The clinical studies required by regulators prior to marketing are small and over-reliant on bench testing in relation to "predicate" products. Once a pump is available on the market, insufficient data are made publicly available on its long-term use in a real

  16. Insulin pump risks and benefits: a clinical appraisal of pump safety standards, adverse event reporting and research needs. A joint statement of the European Association for the Study of Diabetes and the American Diabetes Association Diabetes Technology Working Group.

    PubMed

    Heinemann, Lutz; Fleming, G Alexander; Petrie, John R; Holl, Reinhard W; Bergenstal, Richard M; Peters, Anne L

    2015-05-01

    Insulin pump therapy, also known as continuous subcutaneous insulin infusion (CSII), is an important and evolving form of insulin delivery, which is mainly used for people with type 1 diabetes. However, even with modern insulin pumps, errors of insulin infusion can occur due to pump failure, insulin infusion set (IIS) blockage, infusion site problems, insulin stability issues, user error or a combination of these. Users are therefore exposed to significant and potentially fatal hazards: interruption of insulin infusion can result in hyperglycaemia and ketoacidosis; conversely, delivery of excessive insulin can cause severe hypoglycaemia. Nevertheless, the available evidence on the safety and efficacy of CSII remains limited. The European Association for the Study of Diabetes (EASD) and American Diabetes Association (ADA) have therefore joined forces to review the systems in place for evaluating the safety of pumps from a clinical perspective. We found that useful information held by the manufacturing companies is not currently shared in a sufficiently transparent manner. Public availability of adverse event (AE) reports on the US Food and Drug Administration's Manufacturer and User Facility Device Experience (MAUDE) database is potentially a rich source of safety information but is insufficiently utilised due to the current configuration of the system; the comparable database in Europe (European Databank on Medical Devices, EUDAMED) is not publicly accessible. Many AEs appear to be attributable to human factors and/or user error, but the extent to which manufacturing companies are required by regulators to consider the interactions of users with the technical features of their products is limited. The clinical studies required by regulators prior to marketing are small and over-reliant on bench testing in relation to 'predicate' products. Once a pump is available on the market, insufficient data are made publicly available on its long-term use in a real

  17. A clinical internship model for the nurse practitioner programme.

    PubMed

    Lee, Geraldine A; Fitzgerald, Les

    2008-11-01

    Nurse practitioners in Victoria, Australia must be prepared to Masters level before seeking nurse practitioner (NP) endorsement. The challenge from a university curriculum development perspective was to develop a programme that prepares the NP theoretically and clinically for their advanced practice role. The aim of this discussion paper is to outline how the internship model was developed and report the students' opinions on the model. The NP students complete the internship with a suitably qualified mentor which requires them to work together to develop and maintain a clinical learning plan, keep a log of the weekly meetings that shows how the objectives have been achieved. The internship includes advanced clinical assessment, prescribing, diagnostic and treatment skills and knowledge related to the nurse's specialty. The clinical assessment tool incorporates the National Competency Standards for the Nurse Practitioner and allows students and mentors to identify the level of practice and set clinical objectives. Students were asked to give feedback on the clinical internship and overall their comments were favourable, reporting benefits of a clinical mentor in their work and the clinical case presentations. The clinical internship allows the acquisition of knowledge and clinical skills in the clinical specialty with an expert clinical mentor in this innovative programme.

  18. Hurricanes benefit bleached corals

    PubMed Central

    Manzello, Derek P.; Brandt, Marilyn; Smith, Tyler B.; Lirman, Diego; Hendee, James C.; Nemeth, Richard S.

    2007-01-01

    Recent, global mass-mortalities of reef corals due to record warm sea temperatures have led researchers to consider global warming as one of the most significant threats to the persistence of coral reef ecosystems. The passage of a hurricane can alleviate thermal stress on coral reefs, highlighting the potential for hurricane-associated cooling to mitigate climate change impacts. We provide evidence that hurricane-induced cooling was responsible for the documented differences in the extent and recovery time of coral bleaching between the Florida Reef Tract and the U.S. Virgin Islands during the Caribbean-wide 2005 bleaching event. These results are the only known scenario where the effects of a hurricane can benefit a stressed marine community. PMID:17606914

  19. Hurricanes benefit bleached corals.

    PubMed

    Manzello, Derek P; Brandt, Marilyn; Smith, Tyler B; Lirman, Diego; Hendee, James C; Nemeth, Richard S

    2007-07-17

    Recent, global mass-mortalities of reef corals due to record warm sea temperatures have led researchers to consider global warming as one of the most significant threats to the persistence of coral reef ecosystems. The passage of a hurricane can alleviate thermal stress on coral reefs, highlighting the potential for hurricane-associated cooling to mitigate climate change impacts. We provide evidence that hurricane-induced cooling was responsible for the documented differences in the extent and recovery time of coral bleaching between the Florida Reef Tract and the U.S. Virgin Islands during the Caribbean-wide 2005 bleaching event. These results are the only known scenario where the effects of a hurricane can benefit a stressed marine community.

  20. Atomic bomb health benefits.

    PubMed

    Luckey, T D

    2008-01-01

    Media reports of deaths and devastation produced by atomic bombs convinced people around the world that all ionizing radiation is harmful. This concentrated attention on fear of miniscule doses of radiation. Soon the linear no threshold (LNT) paradigm was converted into laws. Scientifically valid information about the health benefits from low dose irradiation was ignored. Here are studies which show increased health in Japanese survivors of atomic bombs. Parameters include decreased mutation, leukemia and solid tissue cancer mortality rates, and increased average lifespan. Each study exhibits a threshold that repudiates the LNT dogma. The average threshold for acute exposures to atomic bombs is about 100 cSv. Conclusions from these studies of atomic bomb survivors are: One burst of low dose irradiation elicits a lifetime of improved health.Improved health from low dose irradiation negates the LNT paradigm.Effective triage should include radiation hormesis for survivor treatment.

  1. NASA Technology Benefits Orthotics

    NASA Technical Reports Server (NTRS)

    Myers, Neill; Shadoan, Michael

    1998-01-01

    Engineers at NASA's Marshall Space Flight Center (MSFC) in Huntsville, Alabama have designed a knee brace to aid in the rehabilitation of medical patients. The device, called the Selectively Lockable Knee Brace, was designed for knee injury and stroke patients but may potentially serve in many more patient applications. Individuals with sports related injuries, spinal cord injuries and birth defects, such as spina bifida, may also benefit from the device. The Selectively Lockable Knee Brace is designed to provide secure support to the patient when weight is applied to the leg; however; when the leg is not supporting weight, the device allows free motion of the knee joint. Braces currently on the market lock the knee in a rigid, straight or bent position, or by manually pulling a pin, allow continuous free joint motion.

  2. NASA Benefits Earth

    NASA Technical Reports Server (NTRS)

    Robinson, Julie A.

    2009-01-01

    This slide presentation reviews several ways in which NASA research has benefited Earth and made life on Earth better. These innovations include: solar panels, recycled pavement, thermometer pill, invisible braces for straightening teeth, LASIK, aerodynamic helmets and tires for bicycles, cataract detection, technology that was used to remove Anthrax spores from mail handling facilities, study of atomic oxygen erosion of materials has informed the restoration of artwork, macroencapsulation (a potential mechanism to deliver anti cancer drugs to specific sites), and research on a salmonella vaccine. With research on the International Space Station just beginning, there will be opportunities for entrepreneurs and other government agencies to access space for their research and development. As well as NASA continuing its own research on human health and technology development.

  3. Refactoring and Its Benefits

    NASA Astrophysics Data System (ADS)

    Veerraju, R. P. S. P.; Rao, A. Srinivasa; Murali, G.

    2010-10-01

    Refactoring is a disciplined technique for restructuring an existing body of code, altering its internal structure without changing its external behavior. It improves internal code structure without altering its external functionality by transforming functions and rethinking algorithms. It is an iterative process. Refactoring include reducing scope, replacing complex instructions with simpler or built-in instructions, and combining multiple statements into one statement. By transforming the code with refactoring techniques it will be faster to change, execute, and download. It is an excellent best practice to adopt for programmers wanting to improve their productivity. Refactoring is similar to things like performance optimizations, which are also behavior- preserving transformations. It also helps us find bugs when we are trying to fix a bug in difficult-to-understand code. By cleaning things up, we make it easier to expose the bug. Refactoring improves the quality of application design and implementation. In general, three cases concerning refactoring. Iterative refactoring, Refactoring when is necessary, Not refactor. Mr. Martin Fowler identifies four key reasons to refractor. Refactoring improves the design of software, makes software easier to understand, helps us find bugs and also helps in executing the program faster. There is an additional benefit of refactoring. It changes the way a developer thinks about the implementation when not refactoring. There are the three types of refactorings. 1) Code refactoring: It often referred to simply as refactoring. This is the refactoring of programming source code. 2) Database refactoring: It is a simple change to a database schema that improves its design while retaining both its behavioral and informational semantics. 3) User interface (UI) refactoring: It is a simple change to the UI which retains its semantics. Finally, we conclude the benefits of Refactoring are: Improves the design of software, Makes software

  4. Entrepreneur achievement. Liaoning province.

    PubMed

    Zhao, R

    1994-03-01

    This paper reports the successful entrepreneurial endeavors of members of a 20-person women's group in Liaoning Province, China. Jing Yuhong, a member of the Family Planning Association at Shileizi Village, Dalian City, provided the basis for their achievements by first building an entertainment/study room in her home to encourage married women to learn family planning. Once stocked with books, magazines, pamphlets, and other materials on family planning and agricultural technology, dozens of married women in the neighborhood flocked voluntarily to the room. Yuhong also set out to give these women a way to earn their own income as a means of helping then gain greater equality with their husbands and exert greater control over their personal reproductive and social lives. She gave a section of her farming land to the women's group, loaned approximately US$5200 to group members to help them generate income from small business initiatives, built a livestock shed in her garden for the group to raise marmots, and erected an awning behind her house under which mushrooms could be grown. The investment yielded $12,000 in the first year, allowing each woman to keep more than $520 in dividends. Members then soon began going to fairs in the capital and other places to learn about the outside world, and have successfully ventured out on their own to generate individual incomes. Ten out of twenty women engaged in these income-generating activities asked for and got the one-child certificate.

  5. Cardiovascular benefits of bariatric surgery.

    PubMed

    Lee, Glenn K; Cha, Yong-Mei

    2016-04-01

    The prevalence of obesity is increasing in the United States and worldwide, bringing with it an excess of morbidity and premature death. Obesity is strongly associated with both traditional cardiovascular risk factors as well as direct effects on hemodynamics and cardiovascular structure and function. In fact, cardiovascular disease is one of the major causes of morbidity and mortality in obese patients. Often, lifestyle and pharmacological weight-loss interventions are of limited efficacy in severely obese patients. Bariatric surgery has been shown to be a feasible option to achieve substantial and sustained weight loss in this group of patients. It is a safe procedure with low in-hospital and 30-day mortality rates even in groups that are considered higher risk for surgery (e.g., the elderly), especially if performed in high-volume centers. There is observational evidence that bariatric surgery in severely obese patients is associated with both a reduction of traditional cardiovascular risk factors as well as improvement in cardiac structure and function. Marked decreases in the levels of inflammatory and prothrombotic markers, as well as markers of subclinical atherosclerosis and endothelial dysfunction, are seen after bariatric surgery. This article summarizes the existing evidence regarding the cardiovascular benefits in patients following bariatric surgery.

  6. Clinical informatics: a workforce priority for 21st century healthcare.

    PubMed

    Smith, Susan E; Drake, Lesley E; Harris, Julie-Gai B; Watson, Kay; Pohlner, Peter G

    2011-05-01

    This paper identifies the contribution of health and clinical informatics in the support of healthcare in the 21st century. Although little is known about the health and clinical informatics workforce, there is widespread recognition that the health informatics workforce will require significant expansion to support national eHealth work agendas. Workforce issues including discipline definition and self-identification, formal professionalisation, weaknesses in training and education, multidisciplinarity and interprofessional tensions, career structure, managerial support, and financial allocation play a critical role in facilitating or hindering the development of a workforce that is capable of realising the benefits to be gained from eHealth in general and clinical informatics in particular. As well as the national coordination of higher level policies, local support of training and allocation of sufficient position hours in appropriately defined roles by executive and clinical managers is essential to develop the health and clinical informatics workforce and achieve the anticipated results from evolving eHealth initiatives.

  7. Benefit Plans in Higher Education.

    ERIC Educational Resources Information Center

    King, Francis P.; Cook, Thomas J.

    Fifth in a series and the latest of several studies on employee benefits in higher education, this book constitutes a full-scale revision of the earlier "Benefit Plans in American Colleges" (1969). The principal benefit plans provided by U.S. colleges and universities are described, analyzed, and evaluated. Included are retirement (including…

  8. Benefit Plans in Junior Colleges.

    ERIC Educational Resources Information Center

    King, Francis P.

    This study describes the present status of benefit planning in the junior colleges, discusses the principles governing benefit plans, and raises questions regarding the development of sound benefit plans in light of the needs of individual faculty and staff as well as of the goals of the institution. The base of the study was a questionnaire…

  9. Analysis of the Community Benefit Standard in Texas Hospitals.

    PubMed

    Worthy, James Corbett; Anderson, Cheryl L

    2016-01-01

    The federal government provides special tax-exemption status, known as the community benefit standard, to some nonprofit hospitals. It is not known if hospitals that claim the community benefit standard provide more or different services from those provided by hospitals that do not claim the community benefit status. Guided by the socioecological model, this quantitative study investigated 95 hospitals serving 52 counties in South Texas--43 that claimed a community benefit and 52 that did not. The independent variables were hospitals that claimed the community benefit standard versus hospitals that did not. The dependent variables were the three essential criteria and the 13 reported services used to meet the community benefit standard. The study results show that all hospitals that claimed the community benefit standard met two of the three required criteria. However, only 22 of 43 hospitals had a full-time emergency department (ED), the third criterion. Χ² analysis showed statistically significant differences for only two of the five common services: having an ED and community education for community benefit hospitals versus noncommunity benefit hospitals. On average, hospitals that claimed the community benefit spent 100 times more money on community services than hospitals that did not claim the community benefit. Further investigation is needed to determine the reasons for the gap in services pertaining to EDs, trauma care, neonatal intensive care, free-standing clinics, collaborative efforts, other medical services, education of patients, community health education, and other education services. PMID:27111928

  10. Analysis of the Community Benefit Standard in Texas Hospitals.

    PubMed

    Worthy, James Corbett; Anderson, Cheryl L

    2016-01-01

    The federal government provides special tax-exemption status, known as the community benefit standard, to some nonprofit hospitals. It is not known if hospitals that claim the community benefit standard provide more or different services from those provided by hospitals that do not claim the community benefit status. Guided by the socioecological model, this quantitative study investigated 95 hospitals serving 52 counties in South Texas--43 that claimed a community benefit and 52 that did not. The independent variables were hospitals that claimed the community benefit standard versus hospitals that did not. The dependent variables were the three essential criteria and the 13 reported services used to meet the community benefit standard. The study results show that all hospitals that claimed the community benefit standard met two of the three required criteria. However, only 22 of 43 hospitals had a full-time emergency department (ED), the third criterion. Χ² analysis showed statistically significant differences for only two of the five common services: having an ED and community education for community benefit hospitals versus noncommunity benefit hospitals. On average, hospitals that claimed the community benefit spent 100 times more money on community services than hospitals that did not claim the community benefit. Further investigation is needed to determine the reasons for the gap in services pertaining to EDs, trauma care, neonatal intensive care, free-standing clinics, collaborative efforts, other medical services, education of patients, community health education, and other education services.

  11. HEPEX - achievements and challenges!

    NASA Astrophysics Data System (ADS)

    Pappenberger, Florian; Ramos, Maria-Helena; Thielen, Jutta; Wood, Andy; Wang, Qj; Duan, Qingyun; Collischonn, Walter; Verkade, Jan; Voisin, Nathalie; Wetterhall, Fredrik; Vuillaume, Jean-Francois Emmanuel; Lucatero Villasenor, Diana; Cloke, Hannah L.; Schaake, John; van Andel, Schalk-Jan

    2014-05-01

    HEPEX is an international initiative bringing together hydrologists, meteorologists, researchers and end-users to develop advanced probabilistic hydrological forecast techniques for improved flood, drought and water management. HEPEX was launched in 2004 as an independent, cooperative international scientific activity. During the first meeting, the overarching goal was defined as: "to develop and test procedures to produce reliable hydrological ensemble forecasts, and to demonstrate their utility in decision making related to the water, environmental and emergency management sectors." The applications of hydrological ensemble predictions span across large spatio-temporal scales, ranging from short-term and localized predictions to global climate change and regional modeling. Within the HEPEX community, information is shared through its blog (www.hepex.org), meetings, testbeds and intercompaison experiments, as well as project reportings. Key questions of HEPEX are: * What adaptations are required for meteorological ensemble systems to be coupled with hydrological ensemble systems? * How should the existing hydrological ensemble prediction systems be modified to account for all sources of uncertainty within a forecast? * What is the best way for the user community to take advantage of ensemble forecasts and to make better decisions based on them? This year HEPEX celebrates its 10th year anniversary and this poster will present a review of the main operational and research achievements and challenges prepared by Hepex contributors on data assimilation, post-processing of hydrologic predictions, forecast verification, communication and use of probabilistic forecasts in decision-making. Additionally, we will present the most recent activities implemented by Hepex and illustrate how everyone can join the community and participate to the development of new approaches in hydrologic ensemble prediction.

  12. The Homogeneity of School Achievement.

    ERIC Educational Resources Information Center

    Cahan, Sorel

    Since the measurement of school achievement involves the administration of achievement tests to various grades on various subjects, both grade level and subject matter contribute to within-school achievement variations. To determine whether achievement test scores vary most among different fields within a grade level, or within fields among…

  13. Health Benefits of Nut Consumption

    PubMed Central

    Ros, Emilio

    2010-01-01

    Nuts (tree nuts and peanuts) are nutrient dense foods with complex matrices rich in unsaturated fatty and other bioactive compounds: high-quality vegetable protein, fiber, minerals, tocopherols, phytosterols, and phenolic compounds. By virtue of their unique composition, nuts are likely to beneficially impact health outcomes. Epidemiologic studies have associated nut consumption with a reduced incidence of coronary heart disease and gallstones in both genders and diabetes in women. Limited evidence also suggests beneficial effects on hypertension, cancer, and inflammation. Interventional studies consistently show that nut intake has a cholesterol-lowering effect, even in the context of healthy diets, and there is emerging evidence of beneficial effects on oxidative stress, inflammation, and vascular reactivity. Blood pressure, visceral adiposity and the metabolic syndrome also appear to be positively influenced by nut consumption. Thus it is clear that nuts have a beneficial impact on many cardiovascular risk factors. Contrary to expectations, epidemiologic studies and clinical trials suggest that regular nut consumption is unlikely to contribute to obesity and may even help in weight loss. Safety concerns are limited to the infrequent occurrence of nut allergy in children. In conclusion, nuts are nutrient rich foods with wide-ranging cardiovascular and metabolic benefits, which can be readily incorporated into healthy diets. PMID:22254047

  14. Translating diagnostic assays from the laboratory to the clinic: analytical and clinical metrics for device development and evaluation.

    PubMed

    Borysiak, Mark D; Thompson, Matthew J; Posner, Jonathan D

    2016-04-21

    As lab-on-a-chip health diagnostic technologies mature, there is a push to translate them from the laboratory to the clinic. For these diagnostics to achieve maximum impact on patient care, scientists and engineers developing the tests should understand the analytical and clinical statistical metrics that determine the efficacy of the test. Appreciating and using these metrics will benefit test developers by providing consistent measures to evaluate analytical and clinical test performance, as well as guide the design of tests that will most benefit clinicians and patients. This paper is broken into four sections that discuss metrics related to general stages of development including: (1) laboratory assay development (analytical sensitivity, limit of detection, analytical selectivity, and trueness/precision), (2) pre-clinical development (diagnostic sensitivity, diagnostic specificity, clinical cutoffs, and receiver-operator curves), (3) clinical use (prevalence, predictive values, and likelihood ratios), and (4) case studies from existing clinical data for tests relevant to the lab-on-a-chip community (HIV, group A strep, and chlamydia). Each section contains definitions of recommended statistical measures, as well as examples demonstrating the importance of these metrics at various stages of the development process. Increasing the use of these metrics in lab-on-a-chip research will improve the rigor of diagnostic performance reporting and provide a better understanding of how to design tests that will ultimately meet clinical needs. PMID:27043204

  15. Clinical Prediction Rule for Patient Outcome after In-Hospital CPR: A New Model, Using Characteristics Present at Hospital Admission, to Identify Patients Unlikely to Benefit from CPR after In-Hospital Cardiac Arrest

    PubMed Central

    Merja, Satyam; Lilien, Ryan H; Ryder, Hilary F

    2015-01-01

    BACKGROUND Physicians and patients frequently overestimate likelihood of survival after in-hospital cardiopulmonary resuscitation. Discussions and decisions around resuscitation after in-hospital cardiopulmonary arrest often take place without adequate or accurate information. METHODS We conducted a retrospective chart review of 470 instances of resuscitation after in-hospital cardiopulmonary arrest. Individuals were randomly assigned to a derivation cohort and a validation cohort. Logistic Regression and Linear Discriminant Analysis were used to perform multivariate analysis of the data. The resultant best performing rule was converted to a weighted integer tool, and thresholds of survival and nonsurvival were determined with an attempt to optimize sensitivity and specificity for survival. RESULTS A 10-feature rule, using thresholds for survival and nonsurvival, was created; the sensitivity of the rule on the validation cohort was 42.7% and specificity was 82.4%. In the Dartmouth Score (DS), the features of age (greater than 70 years of age), history of cancer, previous cardiovascular accident, and presence of coma, hypotension, abnormal PaO2, and abnormal bicarbonate were identified as the best predictors of nonsurvival. Angina, dementia, and chronic respiratory insufficiency were selected as protective features. CONCLUSIONS Utilizing information easily obtainable on admission, our clinical prediction tool, the DS, provides physicians individualized information about their patients’ probability of survival after in-hospital cardiopulmonary arrest. The DS may become a useful addition to medical expertise and clinical judgment in evaluating and communicating an individual’s probability of survival after in-hospital cardiopulmonary arrest after it is validated by other cohorts. PMID:26448686

  16. The benefits of convergence.

    PubMed

    Chang, Gee-Kung; Cheng, Lin

    2016-03-01

    A multi-tier radio access network (RAN) combining the strength of fibre-optic and radio access technologies employing adaptive microwave photonics interfaces and radio-over-fibre (RoF) techniques is envisioned for future heterogeneous wireless communications. All-band radio spectrum from 0.1 to 100 GHz will be used to deliver wireless services with high capacity, high link speed and low latency. The multi-tier RAN will improve the cell-edge performance in an integrated heterogeneous environment enabled by fibre-wireless integration and networking for mobile fronthaul/backhaul, resource sharing and all-layer centralization of multiple standards with different frequency bands and modulation formats. In essence, this is a 'no-more-cells' architecture in which carrier aggregation among multiple frequency bands can be easily achieved with seamless handover between cells. In this way, current and future mobile network standards such as 4G and 5G can coexist with optimized and continuous cell coverage using multi-tier RoF regardless of the underlying network topology or protocol. In terms of users' experience, the future-proof approach achieves the goals of system capacity, link speed, latency and continuous heterogeneous cell coverage while overcoming the bandwidth crunch in next-generation communication networks. PMID:26809570

  17. Telehealth brings benefits.

    PubMed

    2016-08-01

    A telehealth clinical lead writing in Primary Health Care says that for the NHS to thrive, front line staff and patients must be empowered. New ways of working are needed and the use of technology should be maximised. Telehealth allows nurses to work more efficiently, communicate better with patients and families, and improve health outcomes cost-effectively. The author encourages frontline nurses to implement changes in the work place and suggests NHS Change Day in October as a starting point. The article also notes the importance of social media in opening up opportunities to connect with other nurses. PMID:27484572

  18. Structural role of perceived benefits and barriers to self-care in patients with diabetes

    PubMed Central

    Mohebi, Siamak; Azadbakht, Leila; Feizi, Avat; Sharifirad, Gholamreza; Kargar, Mehdi

    2013-01-01

    Introduction and Goal: In diseases and disorders such as diabetes, treatment and disease management depends mostly on patient's performance. So, self-care is very important in these patients and they can affect their own welfare, functional capabilities, and disease processes by achieving self-care skills. Nowadays, we know that self care follows individual, psychological and social factors which its recognition can assist health care providing systems to carry out educational programs. This study aimed to investigate the role of perceived benefits and barriers in doing self-care behaviors among diabetic patients. Materials and Methods: This study is a narrative review and articles with sectional, cohort, and interventional, clinical trial, qualitative and narrative designs were chosen using databases and academic search engines such as PubMed, SCOPUS, ProQuest, Elsevier and key words like self-care diabetes, perceived benefits and barriers. Persian articles were also selected using databases like IRANMEDEX, MEDLIB, as well as searching the articles in sites of domestic scientific magazines. Results: Reviewed articles’ findings show the average situation of perceived benefits and barriers in diabetic patients regarding self-care. Qualified blood sugar (glucose) control, weight control, happiness feeling and expenses reduction are the most important perceived benefits. The most significant perceived barriers in self-care consist of lack of family support, shame feeling, forgetfulness and not being able to ignore foods’ flavor. Conclusion: Perceived benefits and barriers, as central constructs in some patterns and theories of behavior change, were related to self-care, so that it was directly related to perceived benefits and reversely related to perceived barriers. Therefore, these two constructs can be considered as strategies for promoting self-care behaviors in diabetic patients. PMID:24083287

  19. Health benefits of tennis

    PubMed Central

    Pluim, Babette M; Staal, J Bart; Marks, Bonita L; Miller, Stuart; Miley, Dave

    2007-01-01

    The aim of the study was to explore the role of tennis in the promotion of health and prevention of disease. The focus was on risk factors and diseases related to a sedentary lifestyle, including low fitness levels, obesity, hyperlipidaemia, hypertension, diabetes mellitus, cardiovascular disease, and osteoporosis. A literature search was undertaken to retrieve relevant articles. Structured computer searches of PubMed, Embase, and CINAHL were undertaken, along with hand searching of key journals and reference lists to locate relevant studies published up to March 2007. These had to be cohort studies (of either cross sectional or longitudinal design), case–control studies, or experimental studies. Twenty four studies were identified that dealt with physical fitness of tennis players, including 17 on intensity of play and 16 on maximum oxygen uptake; 17 investigated the relation between tennis and (risk factors for) cardiovascular disease; and 22 examined the effect of tennis on bone health. People who choose to play tennis appear to have significant health benefits, including improved aerobic fitness, a lower body fat percentage, a more favourable lipid profile, reduced risk for developing cardiovascular disease, and improved bone health. PMID:17504788

  20. Thrombectomy assisted by carotid stenting in acute ischemic stroke management: benefits and harms.

    PubMed

    Steglich-Arnholm, Henrik; Holtmannspötter, Markus; Kondziella, Daniel; Wagner, Aase; Stavngaard, Trine; Cronqvist, Mats E; Hansen, Klaus; Højgaard, Joan; Taudorf, Sarah; Krieger, Derk Wolfgang

    2015-12-01

    Extracranial carotid artery occlusion or high-grade stenosis with concomitant intracranial embolism causes severe ischemic stroke and shows poor response rates to intravenous thrombolysis (IVT). Endovascular therapy (EVT) utilizing thrombectomy assisted by carotid stenting was long considered risky because of procedural complexities and necessity of potent platelet inhibition-in particular following IVT. This study assesses the benefits and harms of thrombectomy assisted by carotid stenting and identifies factors associated with clinical outcome and procedural complications. Retrospective single-center analysis of 47 consecutive stroke patients with carotid occlusion or high-grade stenosis and concomitant intracranial embolus treated between September 2011 and December 2014. Benefits included early improvement of stroke severity (NIHSS ≥ 10) or complete remission within 72 h and favorable long-term outcome (mRS ≤ 2). Harms included complications during and following EVT. Mean age was 64.3 years (standard deviation ±12.5), 40 (85%) patients received IVT initially. Median NIHSS was 16 (inter-quartile range 14-19). Mean time from stroke onset to recanalization was 311 min (standard deviation ±78.0). Early clinical improvement was detected in 22 (46%) patients. Favorable outcome at 3 months occurred in 32 (68%) patients. Expedited patient management was associated with favorable clinical outcome. Two (4%) patients experienced symptomatic hemorrhage. Eight (17%) patients experienced stent thrombosis. Four (9%) patients died. Thrombectomy assisted by carotid stenting seems beneficial and reasonably safe with a promising rate of favorable outcome. Nevertheless, adverse events and complications call for additional clinical investigations prior to recommendation as clinical standard. Expeditious patient management is central to achieve good clinical outcome. PMID:26345413

  1. 45 CFR 148.220 - Excepted benefits.

    Code of Federal Regulations, 2012 CFR

    2012-10-01

    ... insurance. These benefits include the following: (1) Limited scope dental or vision benefits. These benefits are dental or vision benefits that are limited in scope to a narrow range or type of benefits that...

  2. 45 CFR 148.220 - Excepted benefits.

    Code of Federal Regulations, 2010 CFR

    2010-10-01

    ... insurance. These benefits include the following: (1) Limited scope dental or vision benefits. These benefits are dental or vision benefits that are limited in scope to a narrow range or type of benefits that...

  3. Separate spheres and indirect benefits

    PubMed Central

    Brock, Dan W

    2003-01-01

    On any plausible account of the basis for health care resource prioritization, the benefits and costs of different alternative resource uses are relevant considerations in the prioritization process. Consequentialists hold that the maximization of benefits with available resources is the only relevant consideration. Non-consequentialists do not reject the relevance of consequences of benefits and costs, but insist that other considerations, and in particular the distribution of benefits and costs, are morally important as well. Whatever one's particular account of morally justified standards for the prioritization of different health interventions, we must be able to measure those interventions' benefits and costs. There are many theoretical and practical difficulties in that measurement, such as how to weigh extending life against improving health and quality of life as well as how different quality of life improvements should be valued, but they are not my concern here. This paper addresses two related issues in assessing benefits and costs for health resource prioritization. First, should benefits be restricted only to health benefits, or include as well other non health benefits such as economic benefits to employers from reducing the lost work time due to illness of their employees? I shall call this the Separate Spheres problem. Second, should only the direct benefits, such as extending life or reducing disability, and direct costs, such as costs of medical personnel and supplies, of health interventions be counted, or should other indirect benefits and costs be counted as well? I shall call this the Indirect Benefits problem. These two issues can have great importance for a ranking of different health interventions by either a cost/benefit or cost effectiveness analysis (CEA) standard. PMID:12773217

  4. 20 CFR 416.1181 - What is a plan to achieve self-support (PASS)?

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... 20 Employees' Benefits 2 2011-04-01 2011-04-01 false What is a plan to achieve self-support (PASS)? 416.1181 Section 416.1181 Employees' Benefits SOCIAL SECURITY ADMINISTRATION SUPPLEMENTAL SECURITY... Self-Support § 416.1181 What is a plan to achieve self-support (PASS)? (a) A PASS must— (1) Be...

  5. 20 CFR 416.1181 - What is a plan to achieve self-support (PASS)?

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... 20 Employees' Benefits 2 2014-04-01 2014-04-01 false What is a plan to achieve self-support (PASS)? 416.1181 Section 416.1181 Employees' Benefits SOCIAL SECURITY ADMINISTRATION SUPPLEMENTAL SECURITY... Self-Support § 416.1181 What is a plan to achieve self-support (PASS)? (a) A PASS must— (1) Be...

  6. 20 CFR 416.1181 - What is a plan to achieve self-support (PASS)?

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... 20 Employees' Benefits 2 2013-04-01 2013-04-01 false What is a plan to achieve self-support (PASS)? 416.1181 Section 416.1181 Employees' Benefits SOCIAL SECURITY ADMINISTRATION SUPPLEMENTAL SECURITY... Self-Support § 416.1181 What is a plan to achieve self-support (PASS)? (a) A PASS must— (1) Be...

  7. 20 CFR 416.1181 - What is a plan to achieve self-support (PASS)?

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 20 Employees' Benefits 2 2012-04-01 2012-04-01 false What is a plan to achieve self-support (PASS)? 416.1181 Section 416.1181 Employees' Benefits SOCIAL SECURITY ADMINISTRATION SUPPLEMENTAL SECURITY... Self-Support § 416.1181 What is a plan to achieve self-support (PASS)? (a) A PASS must— (1) Be...

  8. 20 CFR 416.1181 - What is a plan to achieve self-support (PASS)?

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 20 Employees' Benefits 2 2010-04-01 2010-04-01 false What is a plan to achieve self-support (PASS)? 416.1181 Section 416.1181 Employees' Benefits SOCIAL SECURITY ADMINISTRATION SUPPLEMENTAL SECURITY... Self-Support § 416.1181 What is a plan to achieve self-support (PASS)? (a) A PASS must— (1) Be...

  9. Social Security's special minimum benefit.

    PubMed

    Olsen, K A; Hoffmeyer, D

    Social Security's special minimum primary insurance amount (PIA) provision was enacted in 1972 to increase the adequacy of benefits for regular long-term, low-earning covered workers and their dependents or survivors. At the time, Social Security also had a regular minimum benefit provision for persons with low lifetime average earnings and their families. Concerns were rising that the low lifetime average earnings of many regular minimum beneficiaries resulted from sporadic attachment to the covered workforce rather than from low wages. The special minimum benefit was seen as a way to reward regular, low-earning workers without providing the windfalls that would have resulted from raising the regular minimum benefit to a much higher level. The regular minimum benefit was subsequently eliminated for workers reaching age 62, becoming disabled, or dying after 1981. Under current law, the special minimum benefit will phase out over time, although it is not clear from the legislative history that this was Congress's explicit intent. The phaseout results from two factors: (1) special minimum benefits are paid only if they are higher than benefits payable under the regular PIA formula, and (2) the value of the regular PIA formula, which is indexed to wages before benefit eligibility, has increased faster than that of the special minimum PIA, which is indexed to inflation. Under the Social Security Trustees' 2000 intermediate assumptions, the special minimum benefit will cease to be payable to retired workers attaining eligibility in 2013 and later. Their benefits will always be larger under the regular benefit formula. As policymakers consider Social Security solvency initiatives--particularly proposals that would reduce benefits or introduce investment risk--interest may increase in restoring some type of special minimum benefit as a targeted protection for long-term low earners. Two of the three reform proposals offered by the President's Commission to Strengthen

  10. Attitude Towards Physics and Additional Mathematics Achievement Towards Physics Achievement

    ERIC Educational Resources Information Center

    Veloo, Arsaythamby; Nor, Rahimah; Khalid, Rozalina

    2015-01-01

    The purpose of this research is to identify the difference in students' attitude towards Physics and Additional Mathematics achievement based on gender and relationship between attitudinal variables towards Physics and Additional Mathematics achievement with achievement in Physics. This research focused on six variables, which is attitude towards…

  11. The Impact of Reading Achievement on Overall Academic Achievement

    ERIC Educational Resources Information Center

    Churchwell, Dawn Earheart

    2009-01-01

    This study examined the relationship between reading achievement and achievement in other subject areas. The purpose of this study was to determine if there was a correlation between reading scores as measured by the Standardized Test for the Assessment of Reading (STAR) and academic achievement in language arts, math, science, and social studies…

  12. Comparative costs and benefits of hydrogen vehicles

    SciTech Connect

    Berry, G.D.

    1996-10-01

    The costs and benefits of hydrogen as a vehicle fuel are compared to gasoline, natural gas, and battery-powered vehicles. Costs, energy, efficiency, and tail-pipe and full fuel cycle emissions of air pollutants and greenhouse gases were estimated for hydrogen from a broad range of delivery pathways and scales: from individual vehicle refueling systems to large stations refueling 300 cars/day. Hydrogen production from natural gas, methanol, and ammonia, as well as water electrolysis based on alkaline or polymer electrolytes and steam electrolysis using solid oxide electrolytes are considered. These estimates were compared to estimates for competing fuels and vehicles, and used to construct oil use, air pollutant, and greenhouse gas emission scenarios for the U.S. passenger car fleet from 2005-2050. Fuel costs need not be an overriding concern in evaluating the suitability of hydrogen as a fuel for passenger vehicles. The combined emissions and oil import reduction benefits of hydrogen cars are estimated to be significant, valued at up to {approximately}$400/yr for each hydrogen car when primarily clean energy sources are used for hydrogen production. These benefits alone, however, become tenuous as the basis supporting a compelling rationale for hydrogen fueled vehicles, if efficient, advanced fossil-fuel hybrid electric vehicles (HEV`s) can achieve actual on-road emissions at or below ULEV standards in the 2005-2015 timeframe. It appears a robust rationale for hydrogen fuel and vehicles will need to also consider unique, strategic, and long-range benefits of hydrogen vehicles which can be achieved through the use of production, storage, delivery, and utilization methods for hydrogen which are unique among fuels: efficient use of intermittent renewable energy sources, (e,g, wind, solar), small-scale feasibility, fuel production at or near the point of use, electrolytic production, diverse storage technologies, and electrochemical conversion to electricity.

  13. What Else Should I Know about Clinical Research?

    MedlinePlus

    ... to have the potential risks, benefits, alternatives, and responsibilities of the clinical research explained to them before ... informed about the potential risks, benefits, alternatives, and responsibilities of the clinical trial before they agree to ...

  14. Cherokee Culture and School Achievement.

    ERIC Educational Resources Information Center

    Brown, Anthony D.

    1980-01-01

    Compares the effect of cooperative and competitive behaviors of Cherokee and Anglo American elementary school students on academic achievement. Suggests changes in teaching techniques and lesson organization that might raise academic achievement while taking into consideration tribal traditions that limit scholastic achievement in an…

  15. Who Benefits from Volunteering? Variations in Perceived Benefits

    ERIC Educational Resources Information Center

    Morrow-Howell, Nancy; Hong, Song-Iee; Tang, Fengyan

    2009-01-01

    Purpose: The purpose of this study was to document the benefits of volunteering perceived by older adults and to explain variation in these self-perceived benefits. Design and Methods: This is a quantitative study of 13 volunteer programs and 401 older adults serving in those programs. Program directors completed telephone interviews, and older…

  16. Home Media and Children’s Achievement and Behavior

    PubMed Central

    Hofferth, Sandra L.

    2010-01-01

    This study provides a national picture of the time American 6–12 year olds spent playing video games, using the computer, and watching television at home in 1997 and 2003 and the association of early use with their achievement and behavior as adolescents. Girls benefited from computers more than boys and Black children’s achievement benefited more from greater computer use than did that of White children. Greater computer use in middle childhood was associated with increased achievement for White and Black girls and Black boys, but not White boys. Greater computer play was also associated with a lower risk of becoming socially isolated among girls. Computer use does not crowd out positive learning-related activities, whereas video game playing does. Consequently, increased video game play had both positive and negative associations with the achievement of girls but not boys. For boys, increased video game play was linked to increased aggressive behavior problems. PMID:20840243

  17. Update on tanning: More risks, fewer benefits.

    PubMed

    O'Leary, Ryan E; Diehl, Joseph; Levins, Paul C

    2014-03-01

    The tanning response, classically defined as increased cutaneous pigmentation after solar ultraviolet light exposure, encompasses a variety of protective, reparative, and cosmetic issues. The tanning story is continuously evolving as basic science, clinical research, and public health studies shed light on topics involving: the physiologic mechanisms of tanning, the medical benefits of tanning, the role of sunscreens, the development of "sunless" self-tanners, the use of photocarcinogenic indoor tanning services, and the relatively recent development and promulgation of α-melanocyte-stimulating hormone analogues. High-risk tanning behaviors have become increasingly popular and the incidence of melanoma has risen more rapidly than any other cancer. This review will focus on the risks and benefits of each type of tanning, with an emphasis on issues pertinent to dermatologists who care for adolescents and young adults.

  18. Journey to Magnet: cost vs. benefits.

    PubMed

    Russell, Judith

    2010-01-01

    As hospitals and health systems strive to be an "Employer of Choice", one important goal for their nursing leaders has been the decision to embark on their journey of becoming a designated Magnet facility. Approximately 12 months ago, conversations with a few chief nursing executives uncovered a hot topic concerning the achievement/designation of Magnet status and specifically its cost benefits. With more and more hospitals obtaining Magnet status, these nurse leaders did not know how other organizations felt about their journey including outcomes and were very interested in learning more details about their colleagues' experiences.

  19. Students’ Achievement Goals, Learning-Related Emotions and Academic Achievement

    PubMed Central

    Lüftenegger, Marko; Klug, Julia; Harrer, Katharina; Langer, Marie; Spiel, Christiane; Schober, Barbara

    2016-01-01

    In the present research, the recently proposed 3 × 2 model of achievement goals is tested and associations with achievement emotions and their joint influence on academic achievement are investigated. The study was conducted with 388 students using the 3 × 2 Achievement Goal Questionnaire including the six proposed goal constructs (task-approach, task-avoidance, self-approach, self-avoidance, other-approach, other-avoidance) and the enjoyment and boredom scales from the Achievement Emotion Questionnaire. Exam grades were used as an indicator of academic achievement. Findings from CFAs provided strong support for the proposed structure of the 3 × 2 achievement goal model. Self-based goals, other-based goals and task-approach goals predicted enjoyment. Task-approach goals negatively predicted boredom. Task-approach and other-approach predicted achievement. The indirect effects of achievement goals through emotion variables on achievement were assessed using bias-corrected bootstrapping. No mediation effects were found. Implications for educational practice are discussed. PMID:27199836

  20. Clinical cytomics

    NASA Astrophysics Data System (ADS)

    Tárnok, Attila; Mittag, Anja; Lenz, Dominik

    2006-02-01

    The goal of predictive medicine is the detection of changes in patient's state prior to the clinical manifestation of the deterioration of the patients current status. Therefore, both the diagnostic of diseases like cancer, coronary atherosclerosis or congenital heart failure and the prognosis of the effect specific therapeutics on patients outcome are the main fields of predictive medicine. Clinical Cytomcs is based on the analysis of specimens from the patient by Cytomic technologies that are mainly imaging based techniques and their combinations with other assays. Predictive medicine aims at the recognition of the "fate" of each individual patients in order to yield unequivocal indications for decision making (i.e. how does the patient respond to therapy, react to medication etc.). This individualized prediction is based on the Predictive Medicine by Clinical Cytomics concept. These considerations have recently stimulated the idea of the Human Cytome Project. A major focus of the Human Cytome Project is multiplexed cy-tomic analysis of individual cells of the patient, extraction of predictive information and individual prediction that merges into individualized therapy. Although still at the beginning, Clinical Cytomics is a promising new field that may change therapy in the near future for the benefit of the patients.

  1. Improving Achievement Via Essay Exams.

    ERIC Educational Resources Information Center

    Milton, Ohmer

    1979-01-01

    The benefits of using essay tests rather than objective tests in professional education programs are discussed. Essay tests offer practice in writing, creativity and formal communications. Guidelines for using and scoring a sample essay test in biology are presented. (BH)

  2. Scale-up of HIV treatment through PEPFAR: a historic public health achievement.

    PubMed

    El-Sadr, Wafaa M; Holmes, Charles B; Mugyenyi, Peter; Thirumurthy, Harsha; Ellerbrock, Tedd; Ferris, Robert; Sanne, Ian; Asiimwe, Anita; Hirnschall, Gottfried; Nkambule, Rejoice N; Stabinski, Lara; Affrunti, Megan; Teasdale, Chloe; Zulu, Isaac; Whiteside, Alan

    2012-08-15

    Since its inception in 2003, the US President's Emergency Plan for AIDS Relief (PEPFAR) has been an important driving force behind the global scale-up of HIV care and treatment services, particularly in expansion of access to antiretroviral therapy. Despite initial concerns about cost and feasibility, PEPFAR overcame challenges by leveraging and coordinating with other funders, by working in partnership with the most affected countries, by supporting local ownership, by using a public health approach, by supporting task-shifting strategies, and by paying attention to health systems strengthening. As of September 2011, PEPFAR directly supported initiation of antiretroviral therapy for 3.9 million people and provided care and support for nearly 13 million people. Benefits in terms of prevention of morbidity and mortality have been reaped by those receiving the services, with evidence of societal benefits beyond the anticipated clinical benefits. However, much remains to be accomplished to achieve universal access, to enhance the quality of programs, to ensure retention of patients in care, and to continue to strengthen health systems. PMID:22797746

  3. Scale-up of HIV treatment through PEPFAR: a historic public health achievement.

    PubMed

    El-Sadr, Wafaa M; Holmes, Charles B; Mugyenyi, Peter; Thirumurthy, Harsha; Ellerbrock, Tedd; Ferris, Robert; Sanne, Ian; Asiimwe, Anita; Hirnschall, Gottfried; Nkambule, Rejoice N; Stabinski, Lara; Affrunti, Megan; Teasdale, Chloe; Zulu, Isaac; Whiteside, Alan

    2012-08-15

    Since its inception in 2003, the US President's Emergency Plan for AIDS Relief (PEPFAR) has been an important driving force behind the global scale-up of HIV care and treatment services, particularly in expansion of access to antiretroviral therapy. Despite initial concerns about cost and feasibility, PEPFAR overcame challenges by leveraging and coordinating with other funders, by working in partnership with the most affected countries, by supporting local ownership, by using a public health approach, by supporting task-shifting strategies, and by paying attention to health systems strengthening. As of September 2011, PEPFAR directly supported initiation of antiretroviral therapy for 3.9 million people and provided care and support for nearly 13 million people. Benefits in terms of prevention of morbidity and mortality have been reaped by those receiving the services, with evidence of societal benefits beyond the anticipated clinical benefits. However, much remains to be accomplished to achieve universal access, to enhance the quality of programs, to ensure retention of patients in care, and to continue to strengthen health systems.

  4. First update of the International Xenotransplantation Association consensus statement on conditions for undertaking clinical trials of porcine islet products in type 1 diabetes--Chapter 4: pre-clinical efficacy and complication data required to justify a clinical trial.

    PubMed

    Cooper, David K C; Bottino, Rita; Gianello, Pierre; Graham, Melanie; Hawthorne, Wayne J; Kirk, Allan D; Korsgren, Olle; Park, Chung-Gyu; Weber, Collin

    2016-01-01

    In 2009, the International Xenotransplantation Association (IXA) published a consensus document that provided guidelines and "recommendations" (not regulations) for those contemplating clinical trials of porcine islet transplantation. These guidelines included the IXA's opinion on what constituted "rigorous pre-clinical studies using the most relevant animal models" and were based on "non-human primate testing." We now report our discussion following a careful review of the 2009 guidelines as they relate to pre-clinical testing. In summary, we do not believe there is a need to greatly modify the conclusions and recommendations of the original consensus document. Pre-clinical studies should be sufficiently rigorous to provide optimism that a clinical trial is likely to be safe and has a realistic chance of success, but need not be so demanding that success might only be achieved by very prolonged experimentation, as this would not be in the interests of patients whose quality of life might benefit immensely from a successful islet xenotransplant. We believe these guidelines will be of benefit to both investigators planning a clinical trial and to institutions and regulatory authorities considering a proposal for a clinical trial. In addition, we suggest consideration should be given to establishing an IXA Clinical Trial Advisory Committee that would be available to advise (but not regulate) researchers considering initiating a clinical trial of xenotransplantation. PMID:26916706

  5. Low intensity laser therapy: the clinical approach

    NASA Astrophysics Data System (ADS)

    Kahn, Fred

    2006-02-01

    Recently, there has been significant improvement in the process of research and application of Low Intensity Laser Therapy (LILT). Despite this positive direction, a wide discrepancy between the research component and clinical understanding of the technology remains. In our efforts to achieve better clinical results and more fully comprehend the mechanisms of interaction between light and cells, further studies are required. The clinical results presented in this paper are extrapolated from a wide range of musculoskeletal problems including degenerative osteoarthritis, repetitive motion injuries, sports injuries, etc. The paper includes three separate clinical studies comprising 151, 286 and 576 consecutive patient discharges at our clinic. Each patient studied received a specific course of treatment that was designed for that individual and was modified on a continuing basis as the healing process advanced. On each visit, clinical status correlation with the duration, dosage and other parameters was carried out. The essentials of the treatment consisted of a three stage approach. This involved a photon stream emanating from a number of specified gallium-aluminum-arsenide diodes; stage one, red light array, stage two consisting of an array of infrared diodes and stage three consisting of the application of an infrared laser diode probe. On average, each of these groups required less than 10 treatments per patient and resulted in a significant improvement / cure rate greater than 90% in all conditions treated. This report clearly demonstrates the benefits of LILT, indicating that it should be more widely adapted in all medical therapeutic settings.

  6. Justifying clinical trials for porcine islet xenotransplantation.

    PubMed

    Ellis, Cara E; Korbutt, Gregory S

    2015-01-01

    The development of the Edmonton Protocol encouraged a great deal of optimism that a cell-based cure for type I diabetes could be achieved. However, donor organ shortages prevent islet transplantation from being a widespread solution as the supply cannot possibly equal the demand. Porcine islet xenotransplantation has the potential to address these shortages, and recent preclinical and clinical trials show promising scientific support. Consequently, it is important to consider whether the current science meets the ethical requirements for moving toward clinical trials. Despite the potential risks and the scientific unknowns that remain to be investigated, there is optimism regarding the xenotransplantation of some types of tissue, and enough evidence has been gathered to ethically justify clinical trials for the most safe and advanced area of research, porcine islet transplantation. Researchers must make a concerted effort to maintain a positive image for xenotransplantation, as a few well-publicized failed trials could irrevocably damage public perception of xenotransplantation. Because all of society carries the burden of risk, it is important that the public be involved in the decision to proceed. As new information from preclinical and clinical trials develops, policy decisions should be frequently updated. If at any point evidence shows that islet xenotransplantation is unsafe, then clinical trials will no longer be justified and they should be halted. However, as of now, the expected benefit of an unlimited supply of islets, combined with adequate informed consent, justifies clinical trials for islet xenotransplantation.

  7. Developmental Pathways from Parental Substance Use to Childhood Academic Achievement

    PubMed Central

    Brook, Judith S.; Saar, Naomi S.; Brook, David W.

    2010-01-01

    This cross-sectional study examined the pathways to childhood academic achievement in 209 African American and Puerto Rican children and their mothers. There were three pathways to childhood academic achievement: (a) the mother-child relationship and the child’s personality mediated between parental substance use and childhood academic achievement; (b) the child’s personality mediated between parental education and childhood academic achievement; and (c) there was a direct relationship between the child’s gender and childhood academic achievement. Policy and clinical implications suggest the importance of increasing educational opportunities for all parents, providing substance use treatment and self-esteem workshops, and altering the school curriculum. PMID:20525035

  8. Achievement as Resistance: The Development of a Critical Race Achievement Ideology among Black Achievers

    ERIC Educational Resources Information Center

    Carter, Dorinda J.

    2008-01-01

    In this article, Dorinda Carter examines the embodiment of a critical race achievement ideology in high-achieving black students. She conducted a yearlong qualitative investigation of the adaptive behaviors that nine high-achieving black students developed and employed to navigate the process of schooling at an upper-class, predominantly white,…

  9. Taxability of Educational Benefits Trusts

    ERIC Educational Resources Information Center

    Temple Law Quarterly, 1976

    1976-01-01

    Corporations have found the promise of providing a college education to the children of employees--without the recognition of income to the parent-employee--to be a popular fringe benefit. The Internal Revenue Service has attacked educational benefit trusts in Revenue Ruling 75-448. Implications are discussed. (LBH)

  10. Who Benefits from Pension Enhancements?

    ERIC Educational Resources Information Center

    Koedel, Cory; Ni, Shawn; Podgursky, Michael

    2014-01-01

    During the late 1990s public pension funds across the United States accrued large actuarial surpluses. The seemingly flush conditions of the pension funds led legislators in most states to substantially improve retirement benefits for public workers, including teachers. In this study we examine the benefit enhancements to the teacher pension…

  11. Gauging Technology Costs and Benefits

    ERIC Educational Resources Information Center

    Kaestner, Rich

    2007-01-01

    Regardless of the role technology plays in a school district, district personnel should know the costs associated with technology, understand the consequences of technology purchases, and be able to measure the benefits of technology, so they can make more informed decisions. However, determining costs and benefits of current technology or…

  12. Skin tears: achieving positive clinical and financial outcomes.

    PubMed

    Stephen-Haynes, Jackie

    2012-03-01

    Skin tears are one of the most common wounds found among frail, older individuals, and are considered to be largely preventable. Skin tears occur frequently in those with fragile skin, in neonates and the elderly; particularly those with comorbidities affecting their balance, e.g. postural hypotension, motor neurone disease, diabetes and cerebral vascular accident (CVA). Those taking oral medications including steroids and anticoagulants are also at risk of developing skin tears. The increase in the population of older people is likely to produce a concurrent rise in the number of skin tears. Health professionals and health care assistants have a significant role to play in skin tear prevention, assessment and management.

  13. [Sauna: cardiac and vascular benefits and risks].

    PubMed

    Kluger, Nicolas

    2011-10-01

    Sauna bathing is a traditional activity in Finland that has become popular for the past decades in Europe and in the United States. However, it is still considered that patients with cardiovascular pathologies should avoid sauna bathing. Clinical studies have nevertheless showed that sauna was safe for patients with a stable heart condition (hypertension, coronary disease, stable controlled chronic heart failure). Besides, results from recent Japanese studies seem to point out potential benefits for patients with chronic congestive heart failure, but the results need confirmation.

  14. Highway noise barrier perceived benefit

    NASA Astrophysics Data System (ADS)

    May, D. N.; Osman, M. M.

    1980-05-01

    A laboratory experiment was performed in which 82 subjects judged the benefit of a noise barrier by listening to tape recordings of before-barrier and after-barrier traffic noise. These perceived benefit judgments were related by regression analysis to the barrier attenuation, the before-barrier traffic sound level, and a music background level, all of which were varied over the course of the experiment. Prediction equations were developed for barrier benefit in terms of these sound levels, their purpose being to provide a model for barrier benefit that can be used in barrier site selection and design. An unexpected finding was that barrier benefit was highest when before-barrier sound levels were lowest: i.e., subjects preferred a noise barrier that solved a moderate noise problem over an equally-attenuating barrier that only partially solved a more severe noise problem.

  15. The Mechanics of Human Achievement

    PubMed Central

    Duckworth, Angela L.; Eichstaedt, Johannes C.; Ungar, Lyle H.

    2015-01-01

    Countless studies have addressed why some individuals achieve more than others. Nevertheless, the psychology of achievement lacks a unifying conceptual framework for synthesizing these empirical insights. We propose organizing achievement-related traits by two possible mechanisms of action: Traits that determine the rate at which an individual learns a skill are talent variables and can be distinguished conceptually from traits that determine the effort an individual puts forth. This approach takes inspiration from Newtonian mechanics: achievement is akin to distance traveled, effort to time, skill to speed, and talent to acceleration. A novel prediction from this model is that individual differences in effort (but not talent) influence achievement (but not skill) more substantially over longer (rather than shorter) time intervals. Conceptualizing skill as the multiplicative product of talent and effort, and achievement as the multiplicative product of skill and effort, advances similar, but less formal, propositions by several important earlier thinkers. PMID:26236393

  16. Mathematics Achievement in High- and Low-Achieving Secondary Schools

    ERIC Educational Resources Information Center

    Mohammadpour, Ebrahim; Shekarchizadeh, Ahmadreza

    2015-01-01

    This paper identifies the amount of variance in mathematics achievement in high- and low-achieving schools that can be explained by school-level factors, while controlling for student-level factors. The data were obtained from 2679 Iranian eighth graders who participated in the 2007 Trends in International Mathematics and Science Study. Of the…

  17. Reexamining the Relationship between Academic Achievement and Social Behavior

    ERIC Educational Resources Information Center

    Algozzine, Bob; Wang, Chuang; Violette, Amy S.

    2011-01-01

    Numerous studies have demonstrated the comorbidity of achievement and behavior problems in students identified with learning disabilities and emotional disturbance. The causal basis for this relationship has not been demonstrated, but several theories regarding the association have been posited, and potential benefits related to prevention keep…

  18. Effects of Cochlear Implants on Children's Reading and Academic Achievement

    ERIC Educational Resources Information Center

    Marschark, Marc; Rhoten, Cathy; Fabich, Megan

    2007-01-01

    This article presents a critical analysis of empirical studies assessing literacy and other domains of academic achievement among children with cochlear implants. A variety of recent studies have demonstrated benefits to hearing, language, and speech from implants, leading to assumptions that early implantation and longer periods of implant should…

  19. 34 CFR 106.56 - Fringe benefits.

    Code of Federal Regulations, 2012 CFR

    2012-07-01

    ... benefits. (a) Fringe benefits defined. For purposes of this part, fringe benefits means: Any medical, hospital, accident, life insurance or retirement benefit, service, policy or plan, any profit-sharing...

  20. Attribution theory in science achievement

    NASA Astrophysics Data System (ADS)

    Craig, Martin

    Recent research reveals consistent lags in American students' science achievement scores. Not only are the scores lower in the United States compared to other developed nations, but even within the United States, too many students are well below science proficiency scores for their grade levels. The current research addresses this problem by examining potential malleable factors that may predict science achievement in twelfth graders using 2009 data from the National Assessment of Educational Progress (NAEP). Principle component factor analysis was conducted to determine the specific items that contribute to each overall factor. A series of multiple regressions were then analyzed and formed the predictive value of each of these factors for science achievement. All significant factors were ultimately examined together (also using multiple regression) to determine the most powerful predictors of science achievement, identifying factors that predict science achievement, the results of which suggested interventions to strengthen students' science achievement scores and encourage persistence in the sciences at the college level and beyond. Although there is a variety of research highlighting how students in the US are falling behind other developing nations in science and math achievement, as yet, little research has addressed ways of intervening to address this gap. The current research is a starting point, seeking to identify malleable factors that contribute to science achievement. More specifically, this research examined the types of attributions that predict science achievement in twelfth grade students.

  1. Potential ghrelin-mediated benefits and risks of hydrogen water.

    PubMed

    McCarty, Mark F

    2015-04-01

    Molecular hydrogen (H2) can scavenge hydroxyl radical and diminish the toxicity of peroxynitrite; hence, it has interesting potential for antioxidant protection. Recently, a number of studies have explored the utility of inhaled hydrogen gas, or of hydrogen-saturated water, administered parenterally or orally, in rodent models of pathology and in clinical trials, oftentimes with very positive outcomes. The efficacy of orally ingested hydrogen-rich water (HW) has been particularly surprising, given that only transient and rather small increments in plasma hydrogen can be achieved by this method. A recent study in mice has discovered that orally administered HW provokes increased gastric production of the orexic hormone ghrelin, and that this ghrelin mediates the favorable impact of HW on a mouse model of Parkinson's disease. The possibility that most of the benefits observed with HW in experimental studies are mediated by ghrelin merits consideration. Ghrelin is well known to function as an appetite stimulant and secretagogue for growth hormone, but it influences physiological function throughout the body via interaction with the widely express GHS-R1a receptor. Rodent and, to a more limited extent, clinical studies establish that ghrelin has versatile neuroprotective and cognitive enhancing activity, favorably impacts vascular health, exerts anti-inflammatory activity useful in autoimmune disorders, and is markedly hepatoprotective. The stimulatory impact of ghrelin on GH-IGF-I activity, while potentially beneficial in sarcopenia or cachectic disorders, does raise concerns regarding the long-term impact of ghrelin up-regulation on cancer risk. The impact of ingesting HW water on ghrelin production in humans needs to be evaluated; if HW does up-regulate ghrelin in humans, it may have versatile potential for prevention and control of a number of health disorders.

  2. Potential ghrelin-mediated benefits and risks of hydrogen water.

    PubMed

    McCarty, Mark F

    2015-04-01

    Molecular hydrogen (H2) can scavenge hydroxyl radical and diminish the toxicity of peroxynitrite; hence, it has interesting potential for antioxidant protection. Recently, a number of studies have explored the utility of inhaled hydrogen gas, or of hydrogen-saturated water, administered parenterally or orally, in rodent models of pathology and in clinical trials, oftentimes with very positive outcomes. The efficacy of orally ingested hydrogen-rich water (HW) has been particularly surprising, given that only transient and rather small increments in plasma hydrogen can be achieved by this method. A recent study in mice has discovered that orally administered HW provokes increased gastric production of the orexic hormone ghrelin, and that this ghrelin mediates the favorable impact of HW on a mouse model of Parkinson's disease. The possibility that most of the benefits observed with HW in experimental studies are mediated by ghrelin merits consideration. Ghrelin is well known to function as an appetite stimulant and secretagogue for growth hormone, but it influences physiological function throughout the body via interaction with the widely express GHS-R1a receptor. Rodent and, to a more limited extent, clinical studies establish that ghrelin has versatile neuroprotective and cognitive enhancing activity, favorably impacts vascular health, exerts anti-inflammatory activity useful in autoimmune disorders, and is markedly hepatoprotective. The stimulatory impact of ghrelin on GH-IGF-I activity, while potentially beneficial in sarcopenia or cachectic disorders, does raise concerns regarding the long-term impact of ghrelin up-regulation on cancer risk. The impact of ingesting HW water on ghrelin production in humans needs to be evaluated; if HW does up-regulate ghrelin in humans, it may have versatile potential for prevention and control of a number of health disorders. PMID:25649854

  3. Benefits of acid rain controls

    SciTech Connect

    Hawkins, D.G.

    1984-04-01

    The acid rain debate has been distorted by a mistaken political paradigm. This paradigm holds that acid rain controls will benefit only a few lakes and streams, mostly in the Adirondack Mountains in northeastern New York State. It holds that the costs of a control program will fall on the Midwest but that none of the benefits will occur there since no sensitive lakes and streams are found in that area. The author discussed this problem and pointed out that sulfur dioxide was responsible for several types of pollution damage and that all the states would benefit from the reduction of sulfur dioxide emissions.

  4. Pharmacy benefits: new concepts in plan design.

    PubMed

    Goff, Veronica V

    2002-03-01

    This issue brief examines changes to prescription drug benefit coverage in large employer plans and implications for a Medicare prescription drug benefit. The brief discusses reasons behind employer benefit plan redesign and recent coverage trends, as well as potential paths to modernize benefits. Information is based on a literature review and conversations and interviews with employers, benefit consultants, and pharmacy benefit management executives.

  5. Benefits of Metformin Use for Cholangiocarcinoma.

    PubMed

    Kaewpitoon, Soraya J; Loyd, Ryan A; Rujirakul, Ratana; Panpimanmas, Sukij; Matrakool, Likit; Tongtawee, Taweesak; Kootanavanichpong, Nusorn; Kompor, Ponthip; Chavengkun, Wasugree; Kujapun, Jirawoot; Norkaew, Jun; Ponphimai, Sukanya; Padchasuwan, Natnapa; Pholsripradit, Poowadol; Eksanti, Thawatchai; Phatisena, Tanida; Kaewpitoon, Natthawut

    2015-01-01

    Metformin is an oral anti-hyperglycemic agent, which is the most commonly prescribed medication in the treatment of type-2 diabetes mellitus. It is purportedly associated with a reduced risk for various cancers, mainly exerting anti-proliferation effects on various human cancer cell types, such as pancreas, prostate, breast, stomach and liver. This mini-review highlights the risk and benefit of metformin used for cholangiocarcinoma (CCA) prevention and therapy. The results indicated metformin might be a quite promising strategy CCA prevention and treatment, one mechanism being inhibition of CCA tumor growth by cell cycle arrest in both in vitro and in vivo. The AMPK/mTORC1 pathway in intrahepatic CCA cells is targeted by metformin. Furthermore, metformin inhibited CCA tumor growth via the regulation of Drosha-mediated expression of multiple carcinogenic miRNAs. The use of metformin seems to be safe in patients with cirrhosis, and provides a survival benefit. Once hepatic malignancies are already established, metformin does not offer any therapeutic potential. Clinical trials and epidemiological studies of the benefit of metformin use for CCA should be conducted. To date, whether metformin as a prospective chemotherapeutic for CCA is still questionable and waits further atttention. PMID:26745042

  6. Benefits of Metformin Use for Cholangiocarcinoma.

    PubMed

    Kaewpitoon, Soraya J; Loyd, Ryan A; Rujirakul, Ratana; Panpimanmas, Sukij; Matrakool, Likit; Tongtawee, Taweesak; Kootanavanichpong, Nusorn; Kompor, Ponthip; Chavengkun, Wasugree; Kujapun, Jirawoot; Norkaew, Jun; Ponphimai, Sukanya; Padchasuwan, Natnapa; Pholsripradit, Poowadol; Eksanti, Thawatchai; Phatisena, Tanida; Kaewpitoon, Natthawut

    2015-01-01

    Metformin is an oral anti-hyperglycemic agent, which is the most commonly prescribed medication in the treatment of type-2 diabetes mellitus. It is purportedly associated with a reduced risk for various cancers, mainly exerting anti-proliferation effects on various human cancer cell types, such as pancreas, prostate, breast, stomach and liver. This mini-review highlights the risk and benefit of metformin used for cholangiocarcinoma (CCA) prevention and therapy. The results indicated metformin might be a quite promising strategy CCA prevention and treatment, one mechanism being inhibition of CCA tumor growth by cell cycle arrest in both in vitro and in vivo. The AMPK/mTORC1 pathway in intrahepatic CCA cells is targeted by metformin. Furthermore, metformin inhibited CCA tumor growth via the regulation of Drosha-mediated expression of multiple carcinogenic miRNAs. The use of metformin seems to be safe in patients with cirrhosis, and provides a survival benefit. Once hepatic malignancies are already established, metformin does not offer any therapeutic potential. Clinical trials and epidemiological studies of the benefit of metformin use for CCA should be conducted. To date, whether metformin as a prospective chemotherapeutic for CCA is still questionable and waits further atttention.

  7. The Impact of Structured Note Taking Strategies on Math Achievement of Middle School Students

    ERIC Educational Resources Information Center

    Wilkinson, Gregory Ashley

    2012-01-01

    Student math achievement continues to be a national, state, and local concern. Research suggests that note taking can improve academic achievement, but current research has failed to report how low achievers might benefit from using note taking during math classes. The purpose of this study was to determine if teaching students structured note…

  8. Academic Outcomes from Between-Class Achievement Grouping: The Australian Primary Context

    ERIC Educational Resources Information Center

    Macqueen, Suzanne

    2012-01-01

    Grouping students by academic achievement level has been practised in a wide variety of forms and contexts for over a century. Despite a general consensus in the research that between-class achievement grouping provides no overall benefit for students, the practice has persisted in various guises. Between-class achievement grouping is common in…

  9. Perils of Standardized Achievement Testing

    ERIC Educational Resources Information Center

    Haladyna, Thomas M.

    2006-01-01

    This article argues that the validity of standardized achievement test-score interpretation and use is problematic; consequently, confidence and trust in such test scores may often be unwarranted. The problem is particularly severe in high-stakes situations. This essay provides a context for understanding standardized achievement testing, then…

  10. Poor Results for High Achievers

    ERIC Educational Resources Information Center

    Bui, Sa; Imberman, Scott; Craig, Steven

    2012-01-01

    Three million students in the United States are classified as gifted, yet little is known about the effectiveness of traditional gifted and talented (G&T) programs. In theory, G&T programs might help high-achieving students because they group them with other high achievers and typically offer specially trained teachers and a more advanced…

  11. Parental Involvement and Academic Achievement

    ERIC Educational Resources Information Center

    Goodwin, Sarah Christine

    2015-01-01

    This research study examined the correlation between student achievement and parent's perceptions of their involvement in their child's schooling. Parent participants completed the Parent Involvement Project Parent Questionnaire. Results slightly indicated parents of students with higher level of achievement perceived less demand or invitations…

  12. Examination Regimes and Student Achievement

    ERIC Educational Resources Information Center

    Cosentino de Cohen, Clemencia

    2010-01-01

    Examination regimes at the end of secondary school vary greatly intra- and cross-nationally, and in recent years have undergone important reforms often geared towards increasing student achievement. This research presents a comparative analysis of the relationship between examination regimes and student achievement in the OECD. Using a micro…

  13. General Achievement Trends: New Jersey

    ERIC Educational Resources Information Center

    Center on Education Policy, 2009

    2009-01-01

    This general achievement trends profile includes information that the Center on Education Policy (CEP) and the Human Resources Research Organization (HumRRO) obtained from states from fall 2008 through April 2009. Included herein are: (1) Bullet points summarizing key findings about achievement trends in that state at three performance…

  14. Teaching the Low Level Achiever.

    ERIC Educational Resources Information Center

    Salomone, Ronald E., Ed.

    1986-01-01

    Intended for teachers of the English language arts, the articles in this issue offer suggestions and techniques for teaching the low level achiever. Titles and authors of the articles are as follows: (1) "A Point to Ponder" (Rachel Martin); (2) "Tracking: A Self-Fulfilling Prophecy of Failure for the Low Level Achiever" (James Christopher Davis);…

  15. Family Status and School Achievement.

    ERIC Educational Resources Information Center

    Chalker, Rhoda N.; Horns, Virginia

    This study tested the hypothesis that there is no significant difference in reading achievement among children in grades 2 through 5 related to family structure. Researchers administered the Stanford Achievement Test to 119 students in an Alabama city suburban school system. Of the sample, 69 children lived in intact families and 50 lived in…

  16. General Achievement Trends: North Carolina

    ERIC Educational Resources Information Center

    Center on Education Policy, 2009

    2009-01-01

    This general achievement trends profile includes information that the Center on Education Policy (CEP) and the Human Resources Research Organization (HumRRO) obtained from states from fall 2008 through April 2009. Included herein are: (1) Bullet points summarizing key findings about achievement trends in that state at three performance…

  17. Classroom Composition and Achievement Gains.

    ERIC Educational Resources Information Center

    Leiter, Jeffrey

    1983-01-01

    Third-grade students in high ability groups in mathematics achieved greater gains than students in low ability groups. The opposite results occurred in reading achievement. Possible reasons for this difference include different instructional techniques for reading and math and the effect of home environment on learning. (IS)

  18. Raising Boys' Achievement in Schools.

    ERIC Educational Resources Information Center

    Bleach, Kevan, Ed.

    This book offers insights into the range of strategies and good practice being used to raise the achievement of boys. Case studies by school-based practitioners suggest ideas and measures to address the issue of achievement by boys. The contributions are: (1) "Why the Likely Lads Lag Behind" (Kevan Bleach); (2) "Helping Boys Do Better in Their…

  19. School Size and Student Achievement

    ERIC Educational Resources Information Center

    Riggen, Vicki

    2013-01-01

    This study examined whether a relationship between high school size and student achievement exists in Illinois public high schools in reading and math, as measured by the Prairie State Achievement Exam (PSAE), which is administered to all Illinois 11th-grade students. This study also examined whether the factors of socioeconomic status, English…

  20. Stress Correlates and Academic Achievement.

    ERIC Educational Resources Information Center

    Bentley, Donna Anderson; And Others

    An ongoing concern for educators is the identification of factors that contribute to or are associated with academic achievement; one such group of variables that has received little attention are those involving stress. The relationship between perceived sources of stress and academic achievement was examined to determine if reactions to stress…

  1. Genetic Tests:Clinical Validity and Clinical Utility

    PubMed Central

    Burke, Wylie

    2014-01-01

    When evaluating the appropriate use of new genetic tests, clinicians and health care policymakers must consider the accuracy with which a test identifies a patient’s clinical status (clinical validity) and the risks and benefits resulting from test use (clinical utility). Genetic tests in current use vary in accuracy and potential to improve health outcomes, and these test properties may be influenced by testing technology and the clinical setting in which the test is used. This unit defines clinical validity and clinical utility, provides examples, and considers the implications of these test properties for clinical practice. PMID:24763995

  2. 33 CFR 385.35 - Achievement of the benefits of the Plan.

    Code of Federal Regulations, 2014 CFR

    2014-07-01

    ..., wet, and dry years; or any other method which is based on the best available science. (ii) The pre... environment, and shall periodically update that estimate, as appropriate, based on new information resulting... best available science. The guidance memorandum shall also provide for projects that are...

  3. Placement Year Academic Benefit Revisited: Effects of Demographics, Prior Achievement and Degree Programme

    ERIC Educational Resources Information Center

    Reddy, Peter; Moores, Elisabeth

    2012-01-01

    Investigations of whether students taking undergraduate work placements show greater academic improvement than those who do not have shown inconsistent results. In most studies, sample sizes have been relatively small and few studies have taken into account pre-existing student differences. Here data from over 6000 students at one university over…

  4. 33 CFR 385.35 - Achievement of the benefits of the Plan.

    Code of Federal Regulations, 2012 CFR

    2012-07-01

    ..., wet, and dry years; or any other method which is based on the best available science. (ii) The pre... from changed or unforeseen circumstances, new scientific or technical information, new or updated... curves; quantities available in average, wet, and dry years; or any other method which is based on...

  5. The Benefits of Collective Pedagogical Teacher Culture for Diverse Students' Mathematics Achievement by Academic Engagement

    ERIC Educational Resources Information Center

    Moller, Stephanie; Mickelson, Roslyn Arlin; Stearns, Elizabeth; Bottia, Martha; Banerjee, Neena

    2011-01-01

    Most studies of educational organizations have focused on structural features of schools, such as size, resources, and infrastructure. Research on schools' organizational culture is more sparse. Yet, these studies have suggested that the organizational culture of schools can have important implications for teaching practices and student outcomes.…

  6. [Biochemistry for the benefit of humanity (practical achievements of my scientific work)].

    PubMed

    Huliĭ, M F

    2005-01-01

    Science unites theory and practice, but theory is always in advance. Even our works (mentioned above) which are also important for practice and were awarded the State prizes could not be made without preliminary theoretical investigations. It should be said that our works with elaborated methods of therapy and drugs to treat chronic alcoholism, drug addiction, leucosis are rather of theoretical than of practical importance. Some our works which proved that carbon dioxide is the basis of life are also of especially great theoretical value. The paper deals with the investigations devoted to the problems of biochemistry in cattle breeding (the raising of fat content in milk; elaboration of the efficient method of fodder ensilage; raising of milk yield using the drug "Karboxilin"; development of the methods of isolation of crystalline glucose-oxidase and catalase used for clarifying blood) as well as to the problems of biochemistry in medicine (creation of the drug "Microcid", antileucosis drug "Corectin", drugs "Medichronal" and "Medicit" for treating alcoholism and drug addiction, drug "Namacit" for hindering the organism aging). Great attention is given to the problem of relations between the theoretical conception concerning the importance of CO2 in vital activity of human and animal organism and production of new drugs. PMID:16335264

  7. 33 CFR 385.35 - Achievement of the benefits of the Plan.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... Ensuring Protection of the Natural System and Water Availability Consistent With the Goals and Purpose of..., wet, and dry years; or any other method which is based on the best available science. (ii) The pre...) Identification of water made available and water to be reserved or allocated for the natural system. (1)...

  8. The Benefits of Preschool: Do Children Who Attend Preschool Prior to Kindergarten Achieve Higher Test Scores

    ERIC Educational Resources Information Center

    Harrington, Julie

    2015-01-01

    The purpose of this quantitative study was to determine what, if any, impact that attending a four year old kindergarten program had on five year old kindergarteners reading ability as measured by Dominie testing, compared to those five year olds who did not attend a four year old program at Inman Elementary School. The significance of this study…

  9. 33 CFR 385.35 - Achievement of the benefits of the Plan.

    Code of Federal Regulations, 2011 CFR

    2011-07-01

    ... process for reserving or allocating water or for water management under Florida law. Nothing in this... reservations of water for the natural system under State law in accordance with the Project Implementation... reserving or allocating water or for water management under Florida law. Nothing in this section is...

  10. 33 CFR 385.35 - Achievement of the benefits of the Plan.

    Code of Federal Regulations, 2013 CFR

    2013-07-01

    ... process for reserving or allocating water or for water management under Florida law. Nothing in this... reservations of water for the natural system under State law in accordance with the Project Implementation... reserving or allocating water or for water management under Florida law. Nothing in this section is...

  11. Gender Issues in Gifted Achievement: Are Girls Making Inroads While Boys Fall Behind?

    ERIC Educational Resources Information Center

    Rimm, Sylvia B.

    2015-01-01

    School and life achievement patterns for girls and women differ from those of boys and men. While girls have made dramatic progress in school, they need to be inspired to connect to lifelong achievement. Both research and clinical work at the Ohio-based Family Achievement Clinic find that more boys than girls underachieve in school. There is much…

  12. Adaptive radiotherapy in lung cancer: dosimetric benefits and clinical outcome

    PubMed Central

    Kataria, T; Bisht, S S; Goyal, S; Pushpan, L; Abhishek, A; Govardhan, HB; Kumar, V; Sharma, K; Jain, S; Basu, T; Srivastava, A

    2014-01-01

    Objective: Anatomical changes during radiotherapy (RT) might introduce discrepancies between planned and delivered doses. This study evaluates the need for adaptive treatment in lung cancer RT. Methods: 15 patients with non-small-cell lung cancer, undergoing radical RT with or without concurrent chemotherapy, consecutively underwent planning CT scans at baseline and after 44–46 Gy. Target volumes were delineated on both scans. Phase I delivered 44–46 Gy to the initial planning target volume (PTV). Two Phase II plans for 16–20 Gy were developed on initial and mid-treatment scans, the treatment being delivered with the mid-treatment plan. The second CT structure set was fused with the initial scan data set using dose wash. Volumetric and dosimetric changes in target volumes and critical structures were assessed. Results: There was significant reduction in primary gross tumour volume (34.00%; p = 0.02) and PTV (34.70%; p < 0.01) in the second scan. In Plan 2, delivering the same dose to the initial PTV would have resulted in a significantly higher dose to the lung PTV (V20, 52.18%; V5, 21.76%; mean, 23.93%), contralateral lung (mean, 29.43%), heart (V10, 81.47%; V5, 56.62%; mean, 35.21%) and spinal cord (maximum dose, 37.53%). Conclusion: Treatment replanning can account for anatomical changes during RT and thereby enable better normal tissue sparing, while allowing radical target doses with the possibility of maximizing local control. Advances in knowledge: This study supports the sparse dosimetric data regarding the quantitative tumour volume reduction, re-emphasizing the need for adaptive replanning for minimizing normal tissue toxicity without compromising local control, and adds to the existing body of literature. PMID:24628269

  13. Live surgery at conferences - Clinical benefits and ethical dilemmas.

    PubMed

    Philip-Watson, Joanna; Khan, Shahid A A; Hadjipavlou, Marios; Rane, Abhay; Knoll, Thomas

    2014-09-01

    Live surgical broadcasts (LSBs) are becoming increasingly popular in urological conferences. These activities can provide excellent training opportunities, as they allow the audience to view an operation conducted by world-renowned surgeons, and have the ability to interact with them in real time. However, several ethical considerations have been raised with this practice, which the participating surgeons and conference organisers must appreciate and address carefully. In this article we highlight the ethical considerations related to LSBs and advise on how these should be addressed. We also present the latest recommendations made by the European Association of Urology Live Surgery Committee and discuss alternatives to LSB.

  14. [Theoretical basis and clinical benefits of dry salt inhalation therapy].

    PubMed

    Endre, László

    2015-10-11

    Dry salt inhalation (halotherapy) reproduces the microclimate of salt caves, with beneficial effect on health. Sodium chloride crystals are disrupted into very small particles (with a diameter less than 3 µm), and this powder is artificially exhaled into the air of a comfortable room (its temperature is between 20-22 °C, and the relative humidity is low). The end-concentration of the salt in the air of the room will be between 10-30 mg/m(3). The sick (or healthy) persons spend 30-60 minutes in this room, usually 10-20 times. Due to the greater osmotic pressure the inhaled salt diminishes the oedema of the bronchial mucosa, decreases its inflammation, dissolves the mucus, and makes expectoration easier and faster (expectoration of air pollution and allergens will be faster, too). It inhibits the growth of bacteria and, in some case, kills them. Phagocyte activity is also increased. It has beneficial effect on the well being of the patients, and a relaxation effect on the central nervous system. It can prevent, or at least decrease the frequency of the respiratory tract inflammations. It produces better lung function parameters, diminishes bronchial hyperreactivity, which is the sign of decreasing inflammation. Its beneficial effect is true not only in inflammation of the lower respiratory tract, but also in acute or chronic upper airways inflammations. According to the international literature it has beneficial effect for some chronic dermatological disease, too, such as psoriasis, pyoderma and atopic dermatitis. This treatment (called as Indisó) is available under medical control in Hungary, too.

  15. [Theoretical basis and clinical benefits of dry salt inhalation therapy].

    PubMed

    Endre, László

    2015-10-11

    Dry salt inhalation (halotherapy) reproduces the microclimate of salt caves, with beneficial effect on health. Sodium chloride crystals are disrupted into very small particles (with a diameter less than 3 µm), and this powder is artificially exhaled into the air of a comfortable room (its temperature is between 20-22 °C, and the relative humidity is low). The end-concentration of the salt in the air of the room will be between 10-30 mg/m(3). The sick (or healthy) persons spend 30-60 minutes in this room, usually 10-20 times. Due to the greater osmotic pressure the inhaled salt diminishes the oedema of the bronchial mucosa, decreases its inflammation, dissolves the mucus, and makes expectoration easier and faster (expectoration of air pollution and allergens will be faster, too). It inhibits the growth of bacteria and, in some case, kills them. Phagocyte activity is also increased. It has beneficial effect on the well being of the patients, and a relaxation effect on the central nervous system. It can prevent, or at least decrease the frequency of the respiratory tract inflammations. It produces better lung function parameters, diminishes bronchial hyperreactivity, which is the sign of decreasing inflammation. Its beneficial effect is true not only in inflammation of the lower respiratory tract, but also in acute or chronic upper airways inflammations. According to the international literature it has beneficial effect for some chronic dermatological disease, too, such as psoriasis, pyoderma and atopic dermatitis. This treatment (called as Indisó) is available under medical control in Hungary, too. PMID:26551167

  16. Live surgery at conferences - Clinical benefits and ethical dilemmas.

    PubMed

    Philip-Watson, Joanna; Khan, Shahid A A; Hadjipavlou, Marios; Rane, Abhay; Knoll, Thomas

    2014-09-01

    Live surgical broadcasts (LSBs) are becoming increasingly popular in urological conferences. These activities can provide excellent training opportunities, as they allow the audience to view an operation conducted by world-renowned surgeons, and have the ability to interact with them in real time. However, several ethical considerations have been raised with this practice, which the participating surgeons and conference organisers must appreciate and address carefully. In this article we highlight the ethical considerations related to LSBs and advise on how these should be addressed. We also present the latest recommendations made by the European Association of Urology Live Surgery Committee and discuss alternatives to LSB. PMID:26019946

  17. Risk-benefit assessment of tocolytic drugs.

    PubMed

    Wischnik, A

    1991-01-01

    beta 2-Mimetics are the principal agents used for myometrial relaxation. As all the available drugs also have beta 1-stimulant effects, the various side effects (cardiovascular, pulmonary and metabolic) require a critical consideration of the clinical indications, thorough supervision and combined therapeutic concepts. With regard to clinical indications, 'prophylactic tocolysis' frequently turns out to be unnecessary, as does the treatment of physiological uterine contractions during pregnacy which have no effect on the cervix. The benefit of tocolysis must be seen not so much in a reduction of preterm labour but in enabling the obstetrician and neonatologist to optimise the handling of the premature baby, e.g. by allowing lung maturation or by enabling the patient to reach a centre for perinatal medicine before the birth. Labour-dependent fetal distress situations during birth at term can also be managed successfully. Supervision involves thorough control of both mother (especially of cardiovascular and metabolic parameters, electrolyte and water balance) and fetus (cardiotocography, fetometry) in order to decide individually when possible benefits are outweighed by maternal or fetal risks. Combination of beta 2-mimetic treatment with magnesium therapy reduces the beta-mimetic dosage required, has a cardioprotective action, and reduces the development of drug tolerance and the risk of lung oedema. This combination, therefore, should become routine in tocolytic therapy. If further protection against cardiovascular and risk of lung oedema is required, administration of beta 1-blockers is advisable.

  18. Sildenafil: two decades of benefits or risks?

    PubMed

    Leoni, Luís Antônio B; Leite, Gerson S; Wichi, Rogério B; Rodrigues, Bruno

    2013-09-01

    Sildenafil is a selective inhibitor of cyclic guanosine monophosphate (cGMP)-specific phosphodiesterase type 5 (PDE-5). A patent was registered for this drug in 1990, which expired in 2010. Since expiration, the drug has been marketed under various trade names or as generic drugs. Numerous clinical trials have been conducted addressing the effectiveness of the drug for erectile dysfunction (ED) and its safety regarding the presence or absence of specific comorbidities. After over 20 years in the market, we need to ask: has the scientific community reached a general consensus as to the overall efficacy and safety of the drug? Can we firmly state that the benefits of the drug outweigh its risks? This review suggests that sildenafil is an effective and easily manageable treatment for erectile dysfunction, both in the absence and in the presence of comorbidities. After two decades of the emergence of sildenafil as a drug of choice for the treatment of ED (and the numerous studies and clinical trials undertaken during this time span), it is now possible to state that the benefits of the drug do outweigh the risks, and represent an significant improvement in the quality of life in men with ED. PMID:23758451

  19. Benefits for Children with Disabilities

    MedlinePlus

    ... Social Security . . . 3 Introduction. . . . . . . . . . . . . . . 4 Supplemental Security Income ( SSI) payments for children with disabilities. . . . . 4 Social Security ... for adults disabled since childhood. . . . . 10 Applying for SSI payments or SSDI benefits and how you can ...

  20. Employee Benefit Reporting After ERISA

    ERIC Educational Resources Information Center

    Steen, Wesley W.

    1976-01-01

    The statutory reporting requirements of ERISA and some of the regulations recently promulgated are discussed. All type of employee benefit plans are covered. For journal availability see HE 508 741. (LBH)