WorldWideScience

Sample records for theoretical clinical benefits

  1. Benefits of dietary fiber in clinical nutrition.

    Science.gov (United States)

    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.

  2. Explaining clinical behaviors using multiple theoretical models

    Directory of Open Access Journals (Sweden)

    Eccles Martin P

    2012-10-01

    Full Text Available Abstract Background In the field of implementation research, there is an increased interest in use of theory when designing implementation research studies involving behavior change. In 2003, we initiated a series of five studies to establish a scientific rationale for interventions to translate research findings into clinical practice by exploring the performance of a number of different, commonly used, overlapping behavioral theories and models. We reflect on the strengths and weaknesses of the methods, the performance of the theories, and consider where these methods sit alongside the range of methods for studying healthcare professional behavior change. Methods These were five studies of the theory-based cognitions and clinical behaviors (taking dental radiographs, performing dental restorations, placing fissure sealants, managing upper respiratory tract infections without prescribing antibiotics, managing low back pain without ordering lumbar spine x-rays of random samples of primary care dentists and physicians. Measures were derived for the explanatory theoretical constructs in the Theory of Planned Behavior (TPB, Social Cognitive Theory (SCT, and Illness Representations specified by the Common Sense Self Regulation Model (CSSRM. We constructed self-report measures of two constructs from Learning Theory (LT, a measure of Implementation Intentions (II, and the Precaution Adoption Process. We collected data on theory-based cognitions (explanatory measures and two interim outcome measures (stated behavioral intention and simulated behavior by postal questionnaire survey during the 12-month period to which objective measures of behavior (collected from routine administrative sources were related. Planned analyses explored the predictive value of theories in explaining variance in intention, behavioral simulation and behavior. Results Response rates across the five surveys ranged from 21% to 48%; we achieved the target sample size for three of

  3. Potential benefits and risks of clinical xenotransplantation

    Directory of Open Access Journals (Sweden)

    Cooper DKC

    2012-07-01

    Full Text Available David KC Cooper,1 David Ayares21Thomas E Starzl Transplantation Institute, University of Pittsburgh Medical Center, Pittsburgh, PA, USA; 2Revivicor, Blacksburg, VA, USAAbstract: The transplantation of organs and cells from pigs into humans could overcome the critical and continuing problem of the lack of availability of deceased human organs and cells for clinical transplantation. Developments in the genetic engineering of pigs have enabled considerable progress to be made in the experimental laboratory in overcoming the immune barriers to successful xenotransplantation. With regard to pig organ xenotransplantation, antibody- and cell-mediated rejection have largely been overcome, and the current major barrier is the development of coagulation dysregulation. This is believed to be due to a combination of immune activation of the vascular endothelial cells of the graft and molecular incompatibilities between the pig and primate coagulation–anticoagulation systems. Pigs with new genetic modifications specifically directed to this problem are now becoming available. With regard to less complex tissues, such as islets (for the treatment of diabetes, neuronal cells (for the treatment of Parkinson's disease, and corneas, the remaining barriers are less problematic, and graft survival in nonhuman primate models extends for >1 year in all three cases. In planning the initial clinical trials, consideration will be concentrated on the risk–benefit ratio, based to a large extent on the results of preclinical studies in nonhuman primates. If the benefit to the patient is anticipated to be high, eg, insulin-independent control of glycemia, and the potential risks low, eg, minimal risk of transfer of a porcine infectious agent, then a clinical trial would be justified.Keywords: infection, pigs, genetically-engineered, xenotransplantation, islets, xenotransplantation, organs

  4. Psychopathy in women: theoretical and clinical perspectives

    Directory of Open Access Journals (Sweden)

    Wynn R

    2012-06-01

    Full Text Available Rolf Wynn,1,2 Marita H Høiseth,1 Gunn Pettersen,31Department of Forensic Psychiatry, Division of Addiction and Specialized Psychiatric Services, University Hospital of North Norway, Tromsø, Norway; 2Telemedicine Research Group, Department of Clinical Medicine, 3Department of Health and Care Sciences, Faculty of Health Sciences, University of Tromsø, NorwayAbstract: Prior research on psychopathy has primarily focused on the problem in men. Only a few studies have examined whether psychopathy even exists in women, and if so, how the disorder manifests itself in them. This paper presents a narrative review of the literature on gender and psychopathy. We briefly discuss why this is an important topic for women and we discuss its causes. The concept of psychopathy is defined and related to the diagnostic systems. The discussion includes a presentation of diagnostic tools, including the Hare Psychology Checklist – Revised, which are examined in relationship to the importance of biological gender. While emphasizing the similarities as well as the differences between the sexes, we discuss the matters of prevalence, behavioral expressions, comorbidity, progression, and treatment of the disorder.Keywords: psychopathy, antisocial, dissocial, personality disorder, sex, women, review

  5. [Theoretical basis and clinical benefits of dry salt inhalation therapy].

    Science.gov (United States)

    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.

  6. Training-Based Interventions in Motor Rehabilitation after Stroke: Theoretical and Clinical Considerations

    Directory of Open Access Journals (Sweden)

    Annette Sterr

    2004-01-01

    Full Text Available Basic neuroscience research on brain plasticity, motor learning and recovery has stimulated new concepts in neurological rehabilitation. Combined with the development of set methodological standards in clinical outcome research, these findings have led to a double-paradigm shift in motor rehabilitation: (a the move towards evidence-based procedures for the assessment of clinical outcome & the employment of disablement models to anchor outcome parameters, and (b the introduction of practice-based concepts that are derived from testable models that specify treatment mechanisms. In this context, constraint-induced movement therapy (CIT has played a catalytic role in taking motor rehabilitation forward into the scientific arena. As a theoretically founded and hypothesis-driven intervention, CIT research focuses on two main issues. The first issue is the assessment of long-term clinical benefits in an increasing range of patient groups, and the second issue is the investigation of neuronal and behavioural treatment mechanisms and their interactive contribution to treatment success. These studies are mainly conducted in the research environment and will eventually lead to increased treatment benefits for patients in standard health care. However, gradual but presumably more immediate benefits for patients may be achieved by introducing and testing derivates of the CIT concept that are more compatible with current clinical practice. Here, we summarize the theoretical and empirical issues related to the translation of research-based CIT work into the clinical context of standard health care.

  7. Clinical benefits of electronic health record use: national findings.

    Science.gov (United States)

    King, Jennifer; Patel, Vaishali; Jamoom, Eric W; Furukawa, Michael F

    2014-02-01

    To assess whether physicians' reported electronic health record (EHR) use provides clinical benefits and whether benefits depend on using an EHR meeting Meaningful Use criteria or length of EHR experience. The 2011 Physician Workflow study, representative of U.S. office-based physicians. Cross-sectional data were used to examine the association of EHR use with enhanced patient care overall and nine specific clinical benefits. Most physicians with EHRs reported EHR use enhanced patient care overall (78 percent), helped them access a patient's chart remotely (81 percent), and alerted them to a potential medication error (65 percent) and critical lab values (62 percent). Between 30 and 50 percent of physicians reported that EHR use was associated with clinical benefits related to providing recommended care, ordering appropriate tests, and facilitating patient communication. Using EHRs that met Meaningful Use criteria and having 2 or more years of EHR experience were independently associated with reported benefits. Physicians with EHRs meeting Meaningful Use criteria and longer EHR experience were most likely to report benefits across all 10 measures. Physicians reported EHR use enhanced patient care overall. Clinical benefits were most likely to be reported by physicians using EHRs meeting Meaningful Use criteria and longer EHR experience. © Health Research and Educational Trust.

  8. Recent theoretical, neural, and clinical advances in sustained attention research.

    Science.gov (United States)

    Fortenbaugh, Francesca C; DeGutis, Joseph; Esterman, Michael

    2017-05-01

    Models of attention often distinguish among attention subtypes, with classic models separating orienting, switching, and sustaining functions. Compared with other forms of attention, the neurophysiological basis of sustaining attention has received far less notice, yet it is known that momentary failures of sustained attention can have far-ranging negative effects in healthy individuals, and lasting sustained attention deficits are pervasive in clinical populations. In recent years, however, there has been increased interest in characterizing moment-to-moment fluctuations in sustained attention, in addition to the overall vigilance decrement, and understanding how these neurocognitive systems change over the life span and across various clinical populations. The use of novel neuroimaging paradigms and statistical approaches has allowed for better characterization of the neural networks supporting sustained attention and has highlighted dynamic interactions within and across multiple distributed networks that predict behavioral performance. These advances have also provided potential biomarkers to identify individuals with sustained attention deficits. These findings have led to new theoretical models explaining why sustaining focused attention is a challenge for individuals and form the basis for the next generation of sustained attention research, which seeks to accurately diagnose and develop theoretically driven treatments for sustained attention deficits that affect a variety of clinical populations. © 2017 New York Academy of Sciences.

  9. Benefits of a clinical pharmacokinetic service in optimising ...

    African Journals Online (AJOL)

    Objectives. To study the benefits of a clinical pharmacokinetic service in optimising phenytoin use in the Western Cape. Design. Assessment of the response to treatment was based on the number of seizures during the 3 months before entering the study (first baseline period), 3 months after entering the study (second ...

  10. Clinical Practice Informs Secure Messaging Benefits and Best Practices.

    Science.gov (United States)

    Haun, Jolie N; Hathaway, Wendy; Chavez, Margeaux; Antinori, Nicole; Vetter, Brian; Miller, Brian K; Martin, Tracey L; Kendziora, Lisa; Nazi, Kim M; Melillo, Christine

    2017-10-01

    Background Clinical care team members in Department of Veterans' Affairs (VA) facilities nationwide are working to integrate the use of Secure Messaging (SM) into care delivery and identify innovative uses. Identifying best practices for proactive use of SM is a key factor in its successful implementation and sustained use by VA clinical care team members and veterans. Objectives A collaborative project solicited input from VA clinical care teams about their local practices using SM to provide access to proactive patient-centered care for veterans and enhance workflow. Methods This project implemented a single-item cross-sectional qualitative electronic survey via internal e-mail to local coordinators in all 23 Veterans Integrated Service Networks (VISNs). Content analysis was used to manage descriptive data responses. Descriptive statistics described sample characteristics. Results VA clinical care team members across 15 of 23 VISNs responded to the questionnaire. Content analysis of 171 responses produced two global domains: (1) benefits of SM and (2) SM best practices. Benefits of SM use emphasize enhanced and efficient communication and increased access to care. Care team members incorporate SM into their daily clinical practices, using it to provide services before, during, and after clinical encounters as a best practice. SM users suggest improvements in veteran care, clinical team workflow, and efficient use of health resources. Clinical team members invested in the successful implementation of SM integrate SM into their daily practices to provide meaningful and useful veteran-centered care and improve workflow. Conclusion VA clinical care team members can use SM proactively to create an integrated SM culture. With adequate knowledge and motivation to proactively use this technology, all clinical team members within the VA system can replicate best practices shared by other clinical care teams to generate meaningful and useful interactions with SM

  11. Multiplicity-adjusted semiparametric benefiting subgroup identification in clinical trials.

    Science.gov (United States)

    Schnell, Patrick M; Müller, Peter; Tang, Qi; Carlin, Bradley P

    2018-02-01

    Background A recent focus in the health sciences has been the development of personalized medicine, which includes determining the population for which a given treatment is effective. Due to limited data, identifying the true benefiting population is a challenging task. To tackle this difficulty, the credible subgroups approach provides a pair of bounding subgroups for the true benefiting subgroup, constructed so that one is contained by the benefiting subgroup while the other contains the benefiting subgroup with high probability. However, the method has so far only been developed for parametric linear models. Methods In this article, we develop the details required to follow the credible subgroups approach in more realistic settings by considering nonlinear and semiparametric regression models, supported for regulatory science by conditional power simulations. We also present an improved multiple testing approach using a step-down procedure. We evaluate our approach via simulations and apply it to data from four trials of Alzheimer's disease treatments carried out by AbbVie. Results Semiparametric modeling yields credible subgroups that are more robust to violations of linear treatment effect assumptions, and careful choice of the population of interest as well as the step-down multiple testing procedure result in a higher rate of detection of benefiting types of patients. The approach allows us to identify types of patients that benefit from treatment in the Alzheimer's disease trials. Conclusion Attempts to identify benefiting subgroups of patients in clinical trials are often met with skepticism due to a lack of multiplicity control and unrealistically restrictive assumptions. Our proposed approach merges two techniques, credible subgroups, and semiparametric regression, which avoids these problems and makes benefiting subgroup identification practical and reliable.

  12. Theoretical and clinical overview of affective temperaments in mood disorders

    Directory of Open Access Journals (Sweden)

    Xenia Gonda

    2015-07-01

    Full Text Available Temperaments are imperturbable variations of personality, traits and ways of reacting to the environment that characterize individuals and remain constant throughout several different situations. Temperaments usually play a central role in determining emotional reactions, therefore several temperamental models have attempted to establish the potential relationship between temperaments and affective disorders. According to Hagop Akiskal, affective temperaments are subclinical and subaffective trait-like manifestations of affective disorders. Unlike several models of temperament which were exclusively developed theoretically in order to describe healthy human functioning, later extrapolated to capture the pathological domains of mental and behavioral features, the current model of affective temperaments was developed on classical traditions and mainly based on the observation of subjects with mood disorders and their healthy first degree relatives. There is accumulating evidence concerning the development of affective temperaments based on their adaptive evolutionary characteristics and genetic background, and normative data from large national studies on general and healthy samples indicate their universal characteristics. Studies in affective patient populations indicate that the relationship between affective temperaments and affective illness is more complex than a simple extrapolation from psychopathology and mental health, and affective temperaments may represent a latent state of the staging model, playing a pathoplastic role in mood disorders determining their evolution, clinical features, main characteristics and outcome. A large body of data on affective temperaments has been published during the last decade, deserving a critical analysis presented in this overview.

  13. Evidence based exercise - clinical benefits of high intensity interval training.

    Science.gov (United States)

    Shiraev, Tim; Barclay, Gabriella

    2012-12-01

    Aerobic exercise has a marked impact on cardiovascular disease risk. Benefits include improved serum lipid profiles, blood pressure and inflammatory markers as well as reduced risk of stroke, acute coronary syndrome and overall cardiovascular mortality. Most exercise programs prescribed for fat reduction involve continuous, moderate aerobic exercise, as per Australian Heart Foundation clinical guidelines. This article describes the benefits of exercise for patients with cardiovascular and metabolic disease and details the numerous benefits of high intensity interval training (HIIT) in particular. Aerobic exercise has numerous benefits for high-risk populations and such benefits, especially weight loss, are amplified with HIIT. High intensity interval training involves repeatedly exercising at a high intensity for 30 seconds to several minutes, separated by 1-5 minutes of recovery (either no or low intensity exercise). HIT is associated with increased patient compliance and improved cardiovascular and metabolic outcomes and is suitable for implementation in both healthy and 'at risk' populations. Importantly, as some types of exercise are contraindicated in certain patient populations and HIIT is a complex concept for those unfamiliar to exercise, some patients may require specific assessment or instruction before commencing a HIIT program.

  14. Targeting small airways in asthma: Improvement in clinical benefit?

    DEFF Research Database (Denmark)

    Ulrik, Charlotte Suppli; Lange, Peter

    2010-01-01

    Background and Aim: Disease control is not achieved in a substantial proportion of patients with asthma. Recent advances in aerosol formulations and delivery devices may offer more effective therapy. This review will focus on the importance and potential clinical benefit of targeting the lung...... half the daily dose with no increased risk of systemic effects. Clinical studies of adults with asthma have shown a greater effect of ultrafine ICS, compared with non-ultrafine ICS, on quality of life, small airway patency, and markers of pulmonary and systemic inflammation, but no difference...... with regard to conventional clinical indices of lung function and asthma control. Conclusions: Asthma patients treated with ultrafine ICS, compared with non-ultrafine ICS, have at least similar chance of achieving asthma control at a lower daily dose. Further clinical studies are needed to explore whether...

  15. Targeting small airways in asthma: Improvement in clinical benefit?

    DEFF Research Database (Denmark)

    Ulrik, Charlotte Suppli; Lange, Peter

    2010-01-01

    Background and Aim:  Disease control is not achieved in a substantial proportion of patients with asthma. Recent advances in aerosol formulations and delivery devices may offer more effective therapy. This review will focus on the importance and potential clinical benefit of targeting the lung...... half the daily dose with no increased risk of systemic effects. Clinical studies of adults with asthma have shown a greater effect of ultrafine ICS, compared with non-ultrafine ICS, on quality of life, small airway patency, and markers of pulmonary and systemic inflammation, but no difference...... with regard to conventional clinical indices of lung function and asthma control. Conclusions:  Asthma patients treated with ultrafine ICS, compared with non-ultrafine ICS, have at least similar chance of achieving asthma control at a lower daily dose. Further clinical studies are needed to explore whether...

  16. Development of a theoretical-practical script for clinical simulation.

    Science.gov (United States)

    Fabri, Renata Paula; Mazzo, Alessandra; Martins, José Carlos Amado; Fonseca, Ariadne da Silva; Pedersoli, César Eduardo; Miranda, Fernanda Berchelli Girão; Fumincelli, Laís; Baptista, Rui Carlos Negrão

    2017-04-10

    To develop a theoretical-practical script based on the opinion of experts to be used in simulated clinical activities. Qualitative study through analysis of content of interviews with experts on the theme in order to develop the proposed script. Of the 24 invited experts, 12 specialists from educational institutions in Brazil and abroad participated in the study in compliance with the ethical precepts. The experts responded to questions on the characterization of their study attributes and described the items required for the development of a simulated scenario. In view of the responses obtained, data content was analyzed and classified into units and subunits of significance. The items mentioned for the development of the script generated seven units of significance. The units and subunits of significance were gathered in three stages of the main components of the simulated scenario: prior, preparation, and finals. This study enables an innovative, stimulating teaching experience, making it easier for professors to use the simulation resource as a learning process in an effective and objective manner, as a guide to professors and researchers in the area of clinical simulation. Construir, com base na opinião de peritos, roteiro teórico-prático para uso em atividade clínica simulada. Trata-se de um estudo qualitativo por meio de análise de conteúdo de entrevistas de peritos no assunto para construção do roteiro proposto. Seguido os preceitos éticos, entre os 24 peritos convidados pertencentes a instituições de ensino do Brasil e do exterior. Os peritos responderam a questões sobre a caracterização dos seus atributos de estudo e descreveram os itens imprescindíveis à construção de um cenário simulado. Diante das respostas obtidas, os dados foram analisados em relação ao seu conteúdo e organizados em unidades e subunidades de significância. Participaram 12 especialistas. Os itens mencionados para construção do roteiro originaram sete unidades

  17. Clinical Benefits of Lactoferrin for Infants and Children.

    Science.gov (United States)

    Manzoni, Paolo

    2016-06-01

    To discuss the potential clinical benefits of lactoferrin in preterm and term infants, as well as in young children and to review information on the burden of neonatal sepsis. Current evidence on the mechanisms that explain the role of human milk in the neonatal and infant anti-infective responses will be briefly reviewed and preclinical research data on the potential mechanisms of action by which lactoferrin may impact infant gut health, gut immune development and functions, including the lactoferrin effects on the neonatal microbiome, will be examined. Finally, updated translational research on lactoferrin will be presented and discussed and the current evidence from prospective randomized controlled trials in neonates, infants, and toddlers will be analyzed. These randomized controlled trials demonstrate that lactoferrin has a clinically significant impact on feeding, the microbiome, and clinical outcomes in neonates and infants. Copyright © 2016 Elsevier Inc. All rights reserved.

  18. [3D imaging benefits in clinical pratice of orthodontics].

    Science.gov (United States)

    Frèrejouand, Emmanuel

    2016-12-01

    3D imaging possibilities raised up in the last few years in the orthodontic field. In 2016, it can be used for diagnosis improvement and treatment planning by using digital set up combined to CBCT. It is relevant for orthodontic mechanic updating by creating visible or invisible customised appliances. It forms the basis of numerous scientific researches. The author explains the progress 3D imaging brings to diagnosis and clinics but also highlights the requirements it creates. The daily use of these processes in orthodontic clinical practices needs to be regulated regarding the benefit/risk ratio and the patient satisfaction. The command of the digital work flow created by these technics requires habits modifications from the orthodontist and his staff. © EDP Sciences, SFODF, 2016.

  19. Evidence based exercise: Clinical benefits of high intensity interval training

    National Research Council Canada - National Science Library

    Shiraev, Tim; Barclay, Gabriella

    2012-01-01

    ...: This article describes the benefits of exercise for patients with cardiovascular and metabolic disease and details the numerous benefits of high intensity interval training (HIIT) in particular. Discussion...

  20. Can emergency medicine research benefit from adaptive design clinical trials?

    Science.gov (United States)

    Flight, Laura; Julious, Steven A; Goodacre, Steve

    2017-04-01

    Adaptive design clinical trials use preplanned interim analyses to determine whether studies should be stopped or modified before recruitment is complete. Emergency medicine trials are well suited to these designs as many have a short time to primary outcome relative to the length of recruitment. We hypothesised that the majority of published emergency medicine trials have the potential to use a simple adaptive trial design. We reviewed clinical trials published in three emergency medicine journals between January 2003 and December 2013. We determined the proportion that used an adaptive design as well as the proportion that could have used a simple adaptive design based on the time to primary outcome and length of recruitment. Only 19 of 188 trials included in the review were considered to have used an adaptive trial design. A total of 154/165 trials that were fixed in design had the potential to use an adaptive design. Currently, there seems to be limited uptake in the use of adaptive trial designs in emergency medicine despite their potential benefits to save time and resources. Failing to take advantage of adaptive designs could be costly to patients and research. It is recommended that where practical and logistical considerations allow, adaptive designs should be used for all emergency medicine clinical trials. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing/.

  1. Biochemical Benefits, Diagnosis, and Clinical Risks Evaluation of Kratom

    Directory of Open Access Journals (Sweden)

    Dimy Fluyau

    2017-04-01

    Full Text Available BackgroundKratom (Mitragyna speciosa is a tropical tree with a long history of traditional use in parts of Africa and Southeast Asia. Kratom is also known as Thom, Thang, and Biak. Its leaves and the teas brewed from them have long been used by people in that region to manage pain and opioid withdrawal and to stave off fatigue. Kratom is actually consumed throughout the world for its stimulant effects and as an opioid substitute (in form of tea, chewed, smoked, or ingested in capsules. Some case reports have associated kratom exposure with psychosis, seizures, intrahepatic cholestasis, other medical conditions, and deaths. The clinical manifestations of kratom effects are not well defined and the clinical studies are limited. Data research suggest that both stimulant and sedative dose-dependent effects do exist, in addition to antinociceptive, antidepressant activity, anxiolytic-like effects, and anorectic effects, but a growing concern for the drug’s effects and safety of use has resulted in national and international attention primarily due to an increase in hospital visits and deaths in several countries that are believed to have been caused by extracts of the plant. There is a dearth of double blind controlled studies. In this study, we aim to use existing literature to clarify both benefits and risks of kratom as well as its diagnosis evaluation as kratom misuse is an emerging trend in the Western world.MethodsLiterature review using databases such as Embase, Medline, PubMed, Cochrane Library, and Mendeley from 2007 to 2017 were evaluated by all authors to analyze current state on benefits, risks, and diagnosis evaluation of kratom (M. speciosa.ResultsData analysis suggested that kratom possesses some benefits such as stimulant and sedative effects as wells as antinociceptive effects. It seems to inhibit pro-inflammatory mediator release and vascular permeability and can enhance immunity. In addition, it may be an antidepressant and

  2. Biochemical Benefits, Diagnosis, and Clinical Risks Evaluation of Kratom.

    Science.gov (United States)

    Fluyau, Dimy; Revadigar, Neelambika

    2017-01-01

    Kratom (Mitragyna speciosa) is a tropical tree with a long history of traditional use in parts of Africa and Southeast Asia. Kratom is also known as Thom, Thang, and Biak. Its leaves and the teas brewed from them have long been used by people in that region to manage pain and opioid withdrawal and to stave off fatigue. Kratom is actually consumed throughout the world for its stimulant effects and as an opioid substitute (in form of tea, chewed, smoked, or ingested in capsules). Some case reports have associated kratom exposure with psychosis, seizures, intrahepatic cholestasis, other medical conditions, and deaths. The clinical manifestations of kratom effects are not well defined and the clinical studies are limited. Data research suggest that both stimulant and sedative dose-dependent effects do exist, in addition to antinociceptive, antidepressant activity, anxiolytic-like effects, and anorectic effects, but a growing concern for the drug's effects and safety of use has resulted in national and international attention primarily due to an increase in hospital visits and deaths in several countries that are believed to have been caused by extracts of the plant. There is a dearth of double blind controlled studies. In this study, we aim to use existing literature to clarify both benefits and risks of kratom as well as its diagnosis evaluation as kratom misuse is an emerging trend in the Western world. Literature review using databases such as Embase, Medline, PubMed, Cochrane Library, and Mendeley from 2007 to 2017 were evaluated by all authors to analyze current state on benefits, risks, and diagnosis evaluation of kratom (M. speciosa). Data analysis suggested that kratom possesses some benefits such as stimulant and sedative effects as wells as antinociceptive effects. It seems to inhibit pro-inflammatory mediator release and vascular permeability and can enhance immunity. In addition, it may be an antidepressant and anorectic. However, kratom can cause

  3. [The Bain circuit. Theoretical aspects and clinical use].

    Science.gov (United States)

    Litarczek, G; Tulbure, D; Simionescu, R; Florescu, A; Manov, D

    1980-01-01

    After a concise theoretical presentation of the present stage of semiclosed circuits, the authors assess their personal experience in the use of the Bain system. Under controlled respiration, adminstration of a fresh flow of gases of 70 ml per Kg of body weight-1 per minute-1 (between 4,5 and 6 1 per minute-1) prevents reinchalation. By its characteristics, which include: on optimal control of PaCO2 by a simple variation of the flow of fresh gases, universality, economy, the Bain system has demonstrated its utility in the anesthetics practice.

  4. Antibiotics in aggressive periodontitis, is there a clinical benefit?

    Science.gov (United States)

    Rajendra, Anjana; Spivakovsky, Silvia

    2016-12-01

    Data sourcesMedline, Embase and CENTRAL databases were searched up to December 2014. Unpublished data were sought by searching a database listing unpublished studies OpenGray [http://www.opengrey.eu/], formerly OpenSIGLE.Study selectionRandomised clinical trials assessing treatment of patients with AgP comparing scaling and root planing (SRP) alone with SRP plus a single antibiotic or a combination of drugs with a minimum of three months follow-up were considered. Studies specifically designed to evaluate smokers or subjects with diabetes mellitus and HIV/AIDS were not included.Data extraction and synthesisTwo researchers independently screened titles, abstracts and full texts of the search results. The studies, which fulfilled inclusion criteria, underwent validity assessment and data extraction using a specifically designed form. The quality of included studies was assessed using the Cochranes collaboration tool for risk of bias. Only two of the 11 included trials were considered at a low risk of bias. The data extracted from ten studies was analysed by pair-wise meta-analyses and the data extracted from five studies was included in Bayesian network meta-analyses pooled estimates. The six studies evaluated in the pairwise meta-analyses were excluded in the pooled estimates because four studies included patients with advanced disease only and one study did not present average data for pocket depth (PD) and clinical attachment level (CAL) and another one for using a different mechanical treatment.ResultsFourteen studies reporting 11 randomised clinical trials with a total of 388 patients were included in the review. Nine of 11 studies reported a statistically significant greater gain in full mouth mean clinical attachment (CA) and reduction in probing depth (PD) when a systemic antibiotic was used. From those studies the calculated mean difference for CA gained was 1.08 mm (p < 0.0001) and for PD reduction was 1.05 mm (p< 0.00001) for SRP + Metronidazole (Mtz). For

  5. Clinical Evidence for the Cardiovascular Benefits of Angiotensin Receptor Blockers

    Directory of Open Access Journals (Sweden)

    Georg Nickenig

    2006-03-01

    Full Text Available Targeting the renin-angiotensin-aldosterone system (RAAS, specifically the effector peptide angiotensin II (Ang II, represents a major opportunity for slowing the progression of cardiovascular disease (CVD and, in turn, reducing the risk of morbidity and mortality. Inhibition of angiotensin-converting enzyme (ACE and selective blockade of Ang II AT1 receptors are two approaches through which the pathophysiological effects of Ang II can be targeted. Numerous clinical studies have established the benefits of ACE inhibitors (ACE-Is in lessening the morbidity and mortality burden of CVD. There are, however, tolerability concerns associated with ACE-Is, such as angioedema and dry cough. By blocking Ang II at the AT1 receptor lever, Ang II receptor blockers (ARBs provide a more specific and complete blockade of the deleterious effects of Ang II and tend to have more favourable tolerability. A number of clinical trials have shown that ARBs are not only associated with positive outcomes across the CVD continuum but may also have a role in the prevention or delay of diabetes (a major cardiovascular risk factor. Ongoing trials are aiming to define the place of such agents in lessening morbidity and mortality from CVD.

  6. Clinical Evidence for the Cardiovascular Benefits of Angiotensin Receptor Blockers

    Directory of Open Access Journals (Sweden)

    Georg Nickenig

    2006-03-01

    Full Text Available Targeting the renin-angiotensin-aldosterone system (RAAS, specifically the effector peptide angiotensin II (Ang II, represents a major opportunity for slowing the progression of cardiovascular disease (CVD and, in turn, reducing the risk of morbidity and mortality. Inhibition of angiotensin-converting enzyme (ACE and selective blockade of Ang II AT1 receptors are two approaches through which the pathophysiological effects of Ang II can be targeted. Numerous clinical studies have established the benefits of ACE inhibitors P, (ACE-Is in lessening the morbidity and mortality burden of CVD. There are, however, tolerability concerns associated with ACE-Is, such as angioedema and dry cough. By blocking Ang II at the AT1 receptor level, Ang II receptor blockers (ARBs provide a more specific and complete blockade of the deleterious effects of Ang II and tend to have more favourable tolerability. A number of clinical trials have shown that ARBs are not only associated with positive outcomes across the CVD continuum but may also have a role in the prevention or delay of diabetes (a major cardiovascular risk factor. Ongoing trials are aiming to define the place of such agents in lessening morbidity and mortality from CVD.

  7. [Theoretic and practical content of the clinical embryology].

    Science.gov (United States)

    Trávník, P; Hampl, A; Hűttelová, R; Malenovská, A; Priesnitz, J; Rejthar, D; Záková, J

    2013-08-01

    Clinical embryology is in whole Europe respected health care specialization. The specialists in this field are certified by the European Society of Human Reproduction and Embryology (ESHRE). In the Czech Republic the specialization has been formally established by the Government Order No 31/ 2010 after 30 years unformal existence. Concurrently with the wide development of new techniques in assisted reproduction, there is necessary to define the content of clinical embryology as a health care, scientific and educational discipline. The definition authorized by the Committee of Association of Reproductive Embryology (ARE) is given in this article..

  8. Clinical Benefits of the Immediate Implant Socket Shield Technique.

    Science.gov (United States)

    Saeidi Pour, Reza; Zuhr, Otto; Hürzeler, Markus; Prandtner, Otto; Rafael, Caroline Freitas; Edelhoff, Daniel; Liebermann, Anja

    2017-04-01

    Extraction-socket resorption is considered a major problem that can limit implantological rehabilitation options and compromise the esthetic outcome. Surgical techniques to reduce remodeling are of restricted predictability and commonly require several surgical interventions and grafting. This increases the treatment cost and places a physical and psychological strain on the patient. This clinical case report presents a replacement of an upper canine using the socket-shield technique (SST) with a CAD/CAM surgical guide, resulting in a predictable, high esthetic, and functional result. The SST is an alternative approach to curbing remodeling and resorption by retaining the facial part of the root during tooth extraction. An immediately placed implant supports the facial root fragment, preventing the collapse of the buccal wall. The SST with digital precision planning in combination with a CAD/CAM surgical guide benefits patients by preserving their tissue architecture and causing only insignificant trauma. Furthermore, the SST reduces the number of surgical and prosthetic interventions required to one each for pre-operative planning, surgical procedures, and prosthetic rehabilitation. The socket shield technique is a minimally invasive implantological approach offers patients and clinicians multiple benefits. The socket-shield technique (SST) represents an alternative approach to intervene remodeling and resorption processes by the maintenance of the facial part of the root during tooth extraction. The immediate placement of an implant supports the facial root fragment and thereby prevents a collapse of the buccal wall. The SST associated with a CAD/CAM fabricated surgical guide, can reduce the amount of appointments, due to the immediate fabrication of the definitive restoration with the existing model. Therefore, no further necessary appointments are required apart from first pre-operative planning, second for surgical treatment, and third for prosthetic

  9. Benefits of a Clinical Planning and Coordination Module

    DEFF Research Database (Denmark)

    Jensen, Sanne; Vingtoft, Søren; Nøhr, Christian

    2013-01-01

    the potential benefits of a planning and coordination module has been assessed in a full-scale simulation test including 18 health care professionals. The results showed that health care professionals can benefit from such a module. Furthermore unexpected new possible benefits concerning communication...

  10. Choosing where to work at work - towards a theoretical model of benefits and risks of activity-based flexible offices.

    Science.gov (United States)

    Wohlers, Christina; Hertel, Guido

    2017-04-01

    Although there is a trend in today's organisations to implement activity-based flexible offices (A-FOs), only a few studies examine consequences of this new office type. Moreover, the underlying mechanisms why A-FOs might lead to different consequences as compared to cellular and open-plan offices are still unclear. This paper introduces a theoretical framework explaining benefits and risks of A-FOs based on theories from work and organisational psychology. After deriving working conditions specific for A-FOs (territoriality, autonomy, privacy, proximity and visibility), differences in working conditions between A-FOs and alternative office types are proposed. Further, we suggest how these differences in working conditions might affect work-related consequences such as well-being, satisfaction, motivation and performance on the individual, the team and the organisational level. Finally, we consider task-related (e.g. task variety), person-related (e.g. personality) and organisational (e.g. leadership) moderators. Based on this model, future research directions as well as practical implications are discussed. Practitioner Summary: Activity-based flexible offices (A-FOs) are popular in today's organisations. This article presents a theoretical model explaining why and when working in an A-FO evokes benefits and risks for individuals, teams and organisations. According to the model, A-FOs are beneficial when management encourages employees to use the environment appropriately and supports teams.

  11. A Critical Review of the Theoretical Frameworks and the Conceptual Factors in the Adoption of Clinical Decision Support Systems.

    Science.gov (United States)

    Khong, Peck Chui Betty; Holroyd, Eleanor; Wang, Wenru

    2015-12-01

    The clinical decision support system is utilized to translate knowledge into evidence-based practice in clinical settings. Many studies have been conducted to understand users' adoption of the clinical decision support system. A critical review was conducted to understand the theoretical or conceptual frameworks used to inform the studies on the adoption of the clinical decision support system. The review identified 15 theoretical and conceptual frameworks using multiple hybrids of theories and concepts. The Technology Acceptance Model was the most frequently used baseline framework combined with frameworks such as the diffusion of innovation, social theory, longitudinal theory, and so on. The results from these articles yielded multiple concepts influencing the adoption of the clinical decision support system. These concepts can be recategorized into nine major concepts, namely, the information system, person (user or patient), social, organization, perceived benefits, emotions, trustability, relevance (fitness), and professionalism. None of the studies found all the nine concepts. That said, most of them have identified the information system, organization, and person concepts as three of its concepts affecting the use of the clinical decision support system. Within each of the concepts, its subconcepts were noted to be very varied. Yet each of these subconcepts has significantly contributed toward the different facets of the concepts. A pluralistic framework was built using the concepts and subconcepts to provide an overall framework construct for future study on the adoption of the clinical decision support system.

  12. Staging in bipolar disorder: from theoretical framework to clinical utility.

    Science.gov (United States)

    Berk, Michael; Post, Robert; Ratheesh, Aswin; Gliddon, Emma; Singh, Ajeet; Vieta, Eduard; Carvalho, Andre F; Ashton, Melanie M; Berk, Lesley; Cotton, Susan M; McGorry, Patrick D; Fernandes, Brisa S; Yatham, Lakshmi N; Dodd, Seetal

    2017-10-01

    Illness staging is widely utilized in several medical disciplines to help predict course or prognosis, and optimize treatment. Staging models in psychiatry in general, and bipolar disorder in particular, depend on the premise that psychopathology moves along a predictable path: an at-risk or latency stage, a prodrome progressing to a first clinical threshold episode, and one or more recurrences with the potential to revert or progress to late or end-stage manifestations. The utility and validity of a staging model for bipolar disorder depend on its linking to clinical outcome, treatment response and neurobiological measures. These include progressive biochemical, neuroimaging and cognitive changes, and potentially stage-specific differences in response to pharmacological and psychosocial treatments. Mechanistically, staging models imply the presence of an active disease process that, if not remediated, can lead to neuroprogression, a more malignant disease course and functional deterioration. Biological elements thought to be operative in bipolar disorder include a genetic diathesis, physical and psychic trauma, epigenetic changes, altered neurogenesis and apoptosis, mitochondrial dysfunction, inflammation, and oxidative stress. Many available agents, such as lithium, have effects on these targets. Staging models also suggest the utility of stage-specific treatment approaches that may not only target symptom reduction, but also impede illness neuroprogression. These treatment approaches range from prevention for at-risk individuals, to early intervention strategies for prodromal and newly diagnosed individuals, complex combination therapy for rapidly recurrent illness, and palliative-type approaches for those at chronic, late stages of illness. There is hope that prompt initiation of potentially disease modifying therapies may preclude or attenuate the cognitive and structural changes seen in the later stages of bipolar disorder. The aims of this paper are to: a

  13. Staging in bipolar disorder: from theoretical framework to clinical utility

    Science.gov (United States)

    Berk, Michael; Post, Robert; Ratheesh, Aswin; Gliddon, Emma; Singh, Ajeet; Vieta, Eduard; Carvalho, Andre F.; Ashton, Melanie M.; Berk, Lesley; Cotton, Susan M.; McGorry, Patrick D.; Fernandes, Brisa S.; Yatham, Lakshmi N.; Dodd, Seetal

    2017-01-01

    Illness staging is widely utilized in several medical disciplines to help predict course or prognosis, and optimize treatment. Staging models in psychiatry in general, and bipolar disorder in particular, depend on the premise that psychopathology moves along a predictable path: an at‐risk or latency stage, a prodrome progressing to a first clinical threshold episode, and one or more recurrences with the potential to revert or progress to late or end‐stage manifestations. The utility and validity of a staging model for bipolar disorder depend on its linking to clinical outcome, treatment response and neurobiological measures. These include progressive biochemical, neuroimaging and cognitive changes, and potentially stage‐specific differences in response to pharmacological and psychosocial treatments. Mechanistically, staging models imply the presence of an active disease process that, if not remediated, can lead to neuroprogression, a more malignant disease course and functional deterioration. Biological elements thought to be operative in bipolar disorder include a genetic diathesis, physical and psychic trauma, epigenetic changes, altered neurogenesis and apoptosis, mitochondrial dysfunction, inflammation, and oxidative stress. Many available agents, such as lithium, have effects on these targets. Staging models also suggest the utility of stage‐specific treatment approaches that may not only target symptom reduction, but also impede illness neuroprogression. These treatment approaches range from prevention for at‐risk individuals, to early intervention strategies for prodromal and newly diagnosed individuals, complex combination therapy for rapidly recurrent illness, and palliative‐type approaches for those at chronic, late stages of illness. There is hope that prompt initiation of potentially disease modifying therapies may preclude or attenuate the cognitive and structural changes seen in the later stages of bipolar disorder. The aims of this paper

  14. [Practical and theoretical aspects of cost-benefit relations in viscerosynthesis].

    Science.gov (United States)

    Fuchs, K H; Heimbucher, J; Geiger, D; Thiede, A

    1997-01-01

    The necessity of limiting health care costs requires adequate service recording and quality control even in visceral surgery. In this field, the safety of the anastomoses is of greatest importance. Anastomoses at risk are esophageal connections to jejunum or colon and deep rectal anastomoses. At these locations expensive suture devices, such as stapling instruments, can be used in a cost saving aspect, if they help to increase anastomotic safety, time saving and expansion of surgical indication. Manual sutures thus represent the cheapest anastomotic technique as continuous sutures would cost between DM 10.- to 20.- and single stitch sutures between DM 60.- and 100.-. A surgical school should prevalently aim at training manual anastomoses, while special anastomotic techniques should only complete the skill for selected indications. The overall staff expenditure for extended operations amounts around DM 600.- per hour respectively DM 10.- per minute. Time for surgery might be shortened by auxiliary tools as much as to perform an additional operation. However, a circular stapler anastomosis that costs between DM 650.- to 850.- is twice as expensive as manual sutures notwithstanding the double time needed. In the past years, the necessity for a rational use of different anastomotic techniques has shown to be mandatory since, increasingly, financial aspects of health economy require cost benefit calculations in visceral surgery.

  15. Comparison of statistical and theoretical habitat models for conservation planning: the benefit of ensemble prediction

    Science.gov (United States)

    Jones-Farrand, D. Todd; Fearer, Todd M.; Thogmartin, Wayne E.; Thompson, Frank R.; Nelson, Mark D.; Tirpak, John M.

    2011-01-01

    Selection of a modeling approach is an important step in the conservation planning process, but little guidance is available. We compared two statistical and three theoretical habitat modeling approaches representing those currently being used for avian conservation planning at landscape and regional scales: hierarchical spatial count (HSC), classification and regression tree (CRT), habitat suitability index (HSI), forest structure database (FS), and habitat association database (HA). We focused our comparison on models for five priority forest-breeding species in the Central Hardwoods Bird Conservation Region: Acadian Flycatcher, Cerulean Warbler, Prairie Warbler, Red-headed Woodpecker, and Worm-eating Warbler. Lacking complete knowledge on the distribution and abundance of each species with which we could illuminate differences between approaches and provide strong grounds for recommending one approach over another, we used two approaches to compare models: rank correlations among model outputs and comparison of spatial correspondence. In general, rank correlations were significantly positive among models for each species, indicating general agreement among the models. Worm-eating Warblers had the highest pairwise correlations, all of which were significant (P , 0.05). Red-headed Woodpeckers had the lowest agreement among models, suggesting greater uncertainty in the relative conservation value of areas within the region. We assessed model uncertainty by mapping the spatial congruence in priorities (i.e., top ranks) resulting from each model for each species and calculating the coefficient of variation across model ranks for each location. This allowed identification of areas more likely to be good targets of conservation effort for a species, those areas that were least likely, and those in between where uncertainty is higher and thus conservation action incorporates more risk. Based on our results, models developed independently for the same purpose

  16. The image schema and innate archetypes: theoretical and clinical implications.

    Science.gov (United States)

    Merchant, John

    2016-02-01

    Based in contemporary neuroscience, Jean Knox's 2004 JAP paper 'From archetypes to reflective function' honed her position on image schemas, thereby introducing a model for archetypes which sees them as 'reliably repeated early developmental achievements' and not as genetically inherited, innate psychic structures. The image schema model is used to illustrate how the analyst worked with a patient who began life as an unwanted pregnancy, was adopted at birth and as an adult experienced profound synchronicities, paranormal/telepathic phenomena and visions. The classical approach to such phenomena would see the intense affectivity arising out of a ruptured symbiotic mother-infant relationship constellating certain archetypes which set up the patient's visions. This view is contrasted with Knox's model which sees the archetype an sich as a developmentally produced image schema underpinning the emergence of later imagery. The patient's visions can then be understood to arise from his psychoid body memory related to his traumatic conception and birth. The contemporary neuroscience which supports this view is outlined and a subsequent image schema explanation is presented. Clinically, the case material suggests that a pre-birth perspective needs to be explored in all analytic work. Other implications of Knox's image schema model are summarized. © 2016, The Society of Analytical Psychology.

  17. Proust and perversion: some clinical and theoretical considerations.

    Science.gov (United States)

    Halberstadt-Freud, H C

    1980-01-01

    Relationships may be perserve without"normal" sexuality being replaced by deviant acts and fantasies. The link between perversion and genital sexuality can be loosened without the term becoming inapplicable. Moreover perversions manifest themselves in almost any idiosyncratic form, just like defences. Next to a seemingly not for perverse aim and object, split-off fantasies and acts exist, which form the condition for the "normal" genital sexual relationship. Such a fantasy may be the idea that one's partner has a secret homosexual adventure like in Proust's novel. It can be the need to be unfaithful, or the fantasy of having two lovers instead of one husband, as in the examples given. Perversions can be understood as regulators of self-esteem, and defence against (pre)oedipal conflict. Proust, an expert on perversion and the pre-oedipal, gives us insight into its development, and manifestations: in the mother-child relationship, in love life, in social life and as a sexual perversion in the strict sense of the term. We go into some detail regarding what he tells us about the sado-masochistic fantasies in a love relationship, where paradox seems to be another word for perversion. This is followed by three clinical examples of perverted relationships between partners, with safeguarding of genital aim and object. Perversion seems still more pervasive, more enigmatic and difficult to delineate than in Freud's time.

  18. Stem cell clonality -- theoretical concepts, experimental techniques, and clinical challenges.

    Science.gov (United States)

    Glauche, Ingmar; Bystrykh, Leonid; Eaves, Connie; Roeder, Ingo

    2013-04-01

    Here we report highlights of discussions and results presented at an International Workshop on Concepts and Models of Stem Cell Organization held on July 16th and 17th, 2012 in Dresden, Germany. The goal of the workshop was to undertake a systematic survey of state-of-the-art methods and results of clonality studies of tissue regeneration and maintenance with a particular emphasis on the hematopoietic system. The meeting was the 6th in a series of similar conceptual workshops, termed StemCellMathLab,(2) all of which have had the general objective of using an interdisciplinary approach to discuss specific aspects of stem cell biology. The StemCellMathLab 2012, which was jointly organized by the Institute for Medical Informatics and Biometry, Medical Faculty Carl Gustav Carus, Dresden University of Technology and the Institute for Medical Informatics, Statistics and Epidemiology, Medical Faculty, University of Leipzig, brought together 32 scientists from 8 countries, with scientific backgrounds in medicine, cell biology, virology, physics, computer sciences, bioinformatics and mathematics. The workshop focused on the following questions: (1) How heterogeneous are stem cells and their progeny? and (2) What are the characteristic differences in the clonal dynamics between physiological and pathophysiological situations? In discussing these questions, particular emphasis was placed on (a) the methods for quantifying clones and their dynamics in experimental and clinical settings and (b) general concepts and models for their description. In this workshop summary we start with an introduction to the current state of clonality research and a proposal for clearly defined terminology. Major topics of discussion include clonal heterogeneity in unperturbed tissues, clonal dynamics due to physiological and pathophysiological pressures and conceptual and technical issues of clone quantification. We conclude that an interactive cross-disciplinary approach to research in this

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

    Science.gov (United States)

    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.

  20. Challenges in Measuring Benefit of Clinical Research Training Programs – the ASH Clinical Research Training Institute Example

    OpenAIRE

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

    2015-01-01

    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 collabo...

  1. Health benefits of cereal fibre: a review of clinical trials

    Science.gov (United States)

    Smith, Caren E.; Tucker, Katherine L.

    2011-01-01

    Cereal fibre and whole-grain intakes have been consistently associated in the epidemiological literature with reduced mortality and risk of chronic disease including obesity, CVD and type 2 diabetes. The present review focuses on intervention trials with three primary aims: (1) understanding the mechanisms through which fibre consumption improves health (for example, examination of intermediate endpoints reflecting improved lipid, glucose and energy metabolism); (2) close evaluation of qualitative factors which modify fibre’s effectiveness including physiochemical properties (for example, solubility, fermentability and viscosity), fibre extract molecular weight, fibre particle size and botanical structure of the fibre source grain; and (3) identification of areas in which additional research is needed. The first two aims typify the goals of nutrition research, in that improved understanding of the specific factors which determine fibre’s health benefits has critical implications for dietary recommendations as well as improving understanding of physiological mechanisms. The third aim acknowledges the substantial gap between recommended and actual fibre intakes in many developed countries including the USA and the UK. In recognition of this deficit in total fibre intake, food manufacturing processes increasingly utilise fibre extracts and concentrates as food additives. However, whether fibre extracts provide similar health benefits to the fibre supplied in the constituents of whole grain is largely unexplored. The relative benefits of fibre extracts compared with whole-grain fibre sources therefore represent a critical area in which additional research is needed. PMID:21320383

  2. Do the American Society of Clinical Oncology Value Framework and the European Society of Medical Oncology Magnitude of Clinical Benefit Scale Measure the Same Construct of Clinical Benefit?

    Science.gov (United States)

    Cheng, Sierra; McDonald, Erica J; Cheung, Matthew C; Arciero, Vanessa S; Qureshi, Mahin; Jiang, Di; Ezeife, Doreen; Sabharwal, Mona; Chambers, Alexandra; Han, Dolly; Leighl, Natasha; Sabarre, Kelley-Anne; Chan, Kelvin K W

    2017-08-20

    Purpose Whether the ASCO Value Framework and the European Society for Medical Oncology (ESMO) Magnitude of Clinical Benefit Scale (MCBS) measure similar constructs of clinical benefit is unclear. It is also unclear how they relate to quality-adjusted life-years (QALYs) and funding recommendations in the United Kingdom and Canada. Methods Randomized clinical trials of oncology drug approvals by the US Food and Drug Administration, European Medicines Agency, and Health Canada between 2006 and August 2015 were identified and scored using the ASCO version 1 (v1) framework, ASCO version 2 (v2) framework, and ESMO-MCBS by at least two independent reviewers. Spearman correlation coefficients were calculated to assess construct (between frameworks) and criterion validity (against QALYs from the National Institute for Health and Care Excellence [NICE] and the pan-Canadian Oncology Drug Review [pCODR]). Associations between scores and NICE/pCODR recommendations were examined. Inter-rater reliability was assessed using intraclass correlation coefficients. Results From 109 included randomized clinical trials, 108 ASCOv1, 111 ASCOv2, and 83 ESMO scores were determined. Correlation coefficients for ASCOv1 versus ESMO, ASCOv2 versus ESMO, and ASCOv1 versus ASCOv2 were 0.36 (95% CI, 0.15 to 0.54), 0.17 (95% CI, -0.06 to 0.37), and 0.50 (95% CI, 0.35 to 0.63), respectively. Compared with NICE QALYs, correlation coefficients were 0.45 (ASCOv1), 0.53 (ASCOv2), and 0.46 (ESMO); with pCODR QALYs, coefficients were 0.19 (ASCOv1), 0.20 (ASCOv2), and 0.36 (ESMO). None of the frameworks were significantly associated with NICE/pCODR recommendations. Inter-rater reliability was good for all frameworks. Conclusion The weak-to-moderate correlations of the ASCO frameworks with the ESMO-MCBS, as well as their correlations with QALYs and with NICE/pCODR funding recommendations, suggest different constructs of clinical benefit measured. Construct convergent validity with the ESMO-MCBS did not

  3. ESMO-Magnitude of Clinical Benefit Scale version 1.1

    NARCIS (Netherlands)

    Cherny, N. I.; Dafni, U.; Bogaerts, J.; Latino, N. J.; Pentheroudakis, G.; Douillard, J. -Y.; Tabernero, J.; Zielinski, C.; Piccart, M. J.; de Vries, E. G. E.

    2017-01-01

    Background: The ESMO Magnitude of Clinical Benefit Scale (ESMO-MCBS) version 1.0 (v1.0) was published in May 2015 and was the first version of a validated and reproducible tool to assess the magnitude of clinical benefit from new cancer therapies. The ESMO-MCBS was designed to be a dynamic tool with

  4. Model for investigating the benefits of clinical supervision in psychiatric nursing

    DEFF Research Database (Denmark)

    Gonge, Henrik; Buus, Niels

    2011-01-01

    The objective of this study was to test a model for analysing the possible benefits of clinical supervision. The model suggested a pathway from participation to effectiveness to benefits of clinical supervision, and included possible influences of individual and workplace factors. The study sampl...... indicated that certain individual and workplace factors were related to subscales of the MCSS, as well as some of the benefits. The study supported the suggested model, but methodological limitations apply....

  5. Roflumilast: clinical benefit in patients suffering from COPD

    DEFF Research Database (Denmark)

    Ulrik, Charlotte Suppli; Calverley, Peter Michael Anthony

    2010-01-01

    BACKGROUND AND AIMS: Chronic obstructive pulmonary disease (COPD) is associated with substantial morbidity and mortality and is characterised by persistent airway inflammation, which leads to impaired airway function, quality of life and intermittent exacerbations. In spite of recent advances...... in the treatment of COPD, new treatment options for COPD are clearly necessary. The oral phosphodiesterase-4 (PDE4) inhibitor roflumilast represents a new class of drugs that has shown efficacy and acceptable tolerability in preclinical and short-term clinical studies in patients with COPD. METHODS AND RESULTS......: The available long-term clinical studies reviewed here suggest that the clinical efficacy of roflumilast is likely because of the suppression of airway inflammation and not through bronchodilation. Furthermore, the clinical studies have shown a modest improvement in airway function, including FEV(1...

  6. Roflumilast: clinical benefit in patients suffering from COPD

    DEFF Research Database (Denmark)

    Ulrik, Charlotte Suppli; Calverley, Peter Michael Anthony

    2010-01-01

    BACKGROUND AND AIMS:  Chronic obstructive pulmonary disease (COPD) is associated with substantial morbidity and mortality and is characterised by persistent airway inflammation, which leads to impaired airway function, quality of life and intermittent exacerbations. In spite of recent advances...... in the treatment of COPD, new treatment options for COPD are clearly necessary. The oral phosphodiesterase-4 (PDE4) inhibitor roflumilast represents a new class of drugs that has shown efficacy and acceptable tolerability in preclinical and short-term clinical studies in patients with COPD. METHODS AND RESULTS......: The available long-term clinical studies reviewed here suggest that the clinical efficacy of roflumilast is likely because of the suppression of airway inflammation and not through bronchodilation. Furthermore, the clinical studies have shown a modest improvement in airway function, including FEV(1...

  7. The Translational Science Benefits Model: A New Framework for Assessing the Health and Societal Benefits of Clinical and Translational Sciences.

    Science.gov (United States)

    Luke, Douglas A; Sarli, Cathy C; Suiter, Amy M; Carothers, Bobbi J; Combs, Todd B; Allen, Jae L; Beers, Courtney E; Evanoff, Bradley A

    2017-09-08

    We report the development of the Translational Science Benefits Model (TSBM), a framework designed to support institutional assessment of clinical and translational research outcomes to measure clinical and community health impacts beyond bibliometric measures. The TSBM includes 30 specific and potentially measurable indicators that reflect benefits that accrue from clinical and translational science research such as products, system characteristics, or activities. Development of the TSBM was based on literature review, a modified Delphi method, and in-house expert panel feedback. Three case studies illustrate the feasibility and face validity of the TSBM for identification of clinical and community health impacts that result from translational science activities. Future plans for the TSBM include further pilot testing and a resource library that will be freely available for evaluators, translational scientists, and academic institutions who wish to implement the TSBM framework in their own evaluation efforts. © 2017 The Authors. Clinical and Translational Science published by Wiley Periodicals, Inc. on behalf of American Society for Clinical Pharmacology and Therapeutics.

  8. Telepharmacy: a pharmacist's perspective on the clinical benefits and challenges.

    Science.gov (United States)

    Poudel, Arjun; Nissen, Lisa M

    2016-01-01

    The use of information and telecommunication technologies has expanded at a rapid rate, which has a strong influence on healthcare delivery in many countries. Rural residents and communities, however, often lack easy access to healthcare services due to geographical and demographical factors. Telepharmacy, a more recent concept that refers to pharmaceutical service provision, enables healthcare services, such as medication review, patients counseling, and prescription verification, by a qualified pharmacist for the patients located at a distance from a remotely located hospital, pharmacy, or healthcare center. Telepharmacy has many recognizable benefits such as the easy access to healthcare services in remote and rural locations, economic benefits, patient satisfaction as a result of medication access and information in rural areas, effective patient counseling, and minimal scarcity of local pharmacist and pharmacy services. Telepharmacy undoubtedly is a great concept, but it is sometimes challenging to put into practice. Inherent to the adoption of these practices are legal challenges and pitfalls that need to be addressed. The start-up of telepharmacy (hardware, software, connectivity, and operational cost) involves considerable time, effort, and money. For rural hospitals with fewer patients, the issue of costs appears to be one of the biggest barriers to telepharmacy services. Moreover, execution and implementation of comprehensive and uniform telepharmacy law is still a challenge. A well-developed system, however, can change the practice of pharmacy that is beneficial to both the rural communities and the hospitals or retail pharmacies that deliver these services.

  9. Costs and benefits of nursing clinical education for hospital institutions

    Directory of Open Access Journals (Sweden)

    Olivério Ribeiro

    2014-11-01

    Conclusion: The inferences show that the presence of students in Clinical Teachings in the hospitals leads to a positive balance of 21.57 € per day and service, with a positive reinforcement associated to the resulting citizens satisfaction facing student rendered cares.

  10. Benefits of Outsourcing Strategy and IT Technology in Clinical Trials

    Science.gov (United States)

    Stamenovic, Milorad; Dobraca, Amra

    2017-01-01

    Introduction: Aim of this paper is to describe some of models of outsourcing (numerous and response to different types of risks and increment of quality is based on individual problem and situation). Defining whether to outsource or not and whether to build or buy new information technology (IT) is question for contract research organization (CRO) and Pharma companies dealing with clinical trials, so the aim of this paper is to show business model that could make process of decision making less time consuming, less segmented and more efficient. Material and methods: This paper has a descriptive character, and represents a review of the literature that deals with the described issues. Results: Outsourcing should enable optimal capacity flexibility (technology that is outsourced should be done only optimally not entirely). The goal with CRO partners is to establish equivalent levels of global quality, as extensions of other research and development activities (by unification of standards of performance of alliance partners with best standards of industry). IT is gaining greater significance at each stage of clinical study and represent an inevitable element of the quality of a clinical study (for the purpose of monitoring of clinical site activities, data collection and management, medical monitoring, statistical programming, statistical analysis, clinical study reporting). Conclusion: CROs are able to maximize work within the CRO global development, to support the notion of a fully integrated outsourced company; facilitate the use of similar business processes and norms, reusing established CRO standards and improve CRO operational decision making within outsourced studies by providing consistent and current information across outsourced and in-house activities. PMID:29114116

  11. Benefits of Outsourcing Strategy and IT Technology in Clinical Trials.

    Science.gov (United States)

    Stamenovic, Milorad; Dobraca, Amra

    2017-09-01

    Aim of this paper is to describe some of models of outsourcing (numerous and response to different types of risks and increment of quality is based on individual problem and situation). Defining whether to outsource or not and whether to build or buy new information technology (IT) is question for contract research organization (CRO) and Pharma companies dealing with clinical trials, so the aim of this paper is to show business model that could make process of decision making less time consuming, less segmented and more efficient. This paper has a descriptive character, and represents a review of the literature that deals with the described issues. Outsourcing should enable optimal capacity flexibility (technology that is outsourced should be done only optimally not entirely). The goal with CRO partners is to establish equivalent levels of global quality, as extensions of other research and development activities (by unification of standards of performance of alliance partners with best standards of industry). IT is gaining greater significance at each stage of clinical study and represent an inevitable element of the quality of a clinical study (for the purpose of monitoring of clinical site activities, data collection and management, medical monitoring, statistical programming, statistical analysis, clinical study reporting). CROs are able to maximize work within the CRO global development, to support the notion of a fully integrated outsourced company; facilitate the use of similar business processes and norms, reusing established CRO standards and improve CRO operational decision making within outsourced studies by providing consistent and current information across outsourced and in-house activities.

  12. Vestibular rehabilitation: clinical benefits to patients with Parkinson's disease

    OpenAIRE

    Zeigelboim, Bianca Simone [UNIFESP; Klagenberg, Karlin Fabianne; TEIVE, HÉLIO A. GHIZONI; Munhoz,Renato Puppi; Martins-Bassetto,Jackeline

    2009-01-01

    OBJECTIVE: To evaluate the effectiveness of the vestibular rehabilitation (VR) exercises by means of an assessment before and after the application of the Brazilian version of the Dizziness Handicap Inventory (DHI) questionnaire. METHOD: Twelve patients were studied, the following procedures were carried out: anamnesis, otorhinolaryngological and vestibular evaluation, and the application of the DHI before and after the VR. RESULTS: Clinically resting tremors and subjective postural instabili...

  13. Facilitating the Clinical Integration of Nanomedicines: The Roles of Theoretical and Computational Scientists.

    Science.gov (United States)

    Decuzzi, Paolo

    2016-09-27

    Since the launch of multiple research initiatives on nanotechnology applied to medicine in the early 2000s, a plethora of nanomedicines have been developed that exhibit great therapeutic efficacy in preclinical models but yet minimal impact in daily clinical practice. The successful and complete clinical fruition of nanomedicines requires addressing three major technical challenges: improving loading efficacy and on-command release, modulating recognition and sequestration by immune cells, and maximizing accumulation at biological targets. In this Perspective, I describe how theoretical and computational models can help address each of these challenges. This armamentarium represents an ideal tool for maximizing the therapeutic efficacy of nanomedicines, thus facilitating their integration into daily clinical operations.

  14. Vestibular rehabilitation: clinical benefits to patients with Parkinson's disease.

    Science.gov (United States)

    Zeigelboim, Bianca Simone; Klagenberg, Karlin Fabianne; Teive, Hélio A Ghizoni; Munhoz, Renato Puppi; Martins-Bassetto, Jackeline

    2009-06-01

    To evaluate the effectiveness of the vestibular rehabilitation (VR) exercises by means of an assessment before and after the application of the Brazilian version of the Dizziness Handicap Inventory (DHI) questionnaire. Twelve patients were studied, the following procedures were carried out: anamnesis, otorhinolaryngological and vestibular evaluation, and the application of the DHI before and after the VR. Clinically resting tremors and subjective postural instability were the motor complaints most frequently associated with complaints of vertigo in 12 cases (100%); in the vestibular exam, all the patients presented abnormalities, frequently from the uni and bilateral peripheral vestibular deficiency syndromes in 10 cases (83.3%); there was significant improvement in the physical, functional and emotional aspects of the DHI after the completion of the VR. The VR following the Cawthorne and Cooksey protocol were shown to be useful in managing subjective complaints of several aspects evaluated in this protocol.

  15. Telecytology: Clinical applications, current challenges, and future benefits

    Directory of Open Access Journals (Sweden)

    Michael Thrall

    2011-01-01

    Full Text Available Telecytology is the interpretation of cytology material at a distance using digital images. For more than a decade, pioneering efforts to introduce telecytology into clinical practice have been reported. A Medline search for "telecytology" and "cytology" reveals a voluminous literature, though much of what has been published to date is based on technologies that are rapidly becoming obsolete. The technological limitations of previous techniques, including the transmission of static digital images and dynamic streaming images, have limited telecytology to minor niches. The primary problem with these technologies is that the remote viewer can only see a small fraction of the material on the original slides, introducing the possibility of diagnostic error based not only on image quality but also on image selection. Remote robotic microscopy offers one possible solution to this problem, but to date has found limited acceptance, principally attributable to slow operating times. Whole slide imaging seems to be a much more promising solution, though cytology-specific literature regarding its use is still scant. The advent of whole slide imaging opens up new possibilities for telecytology by enabling high-quality images of entire cytology specimens to be available to anyone, anywhere via the Internet. Although challenges remain, especially with regard to capturing the full microscopy experience including multiple planes of focus and sharp high-powered images, rapidly advancing technology promises to overcome these limitations. Increasing application of whole slide imaging technology in surgical pathology will undoubtedly also increase its application to cytology due to the increasing affordability and practicality of the equipment as it serves a larger number of useful roles within a pathology department. The current and expanding applications of telecytology for clinical practice, education, quality assurance, and testing will be reviewed.

  16. HPV vaccine cross-protection: Highlights on additional clinical benefit.

    Science.gov (United States)

    De Vincenzo, Rosa; Ricci, Caterina; Conte, Carmine; Scambia, Giovanni

    2013-09-01

    Prophylactic human papillomavirus (HPV) vaccines are administered in vaccination programs, targeted at young adolescent girls before sexual exposure, and in catch-up programs for young women in some countries. All the data indicate that HPV-virus-like particles (VLPs) effectively prevent papillomavirus infections with a high level of antibodies and safety. Since non-vaccine HPV types are responsible for about 30% of cervical cancers, cross-protection would potentially enhance primary cervical cancer prevention efforts. High levels of specific neutralizing antibodies can be generated after immunization with HPV VLPs. Immunity to HPV is type-specific. However, if we consider the phylogenetic tree including the different HPV types, we realize that a certain degree of cross-protection is possible, due to the high homology of some viral types with vaccine ones. The assessment of cross-protective properties of HPV vaccines is an extremely important matter, which has also increased public health implications and could add further value to their preventive potential. The impact of cross-protection is mostly represented by a reduction of cervical intraepithelial neoplasia CIN2-3 more than what expected. In this article we review the mechanisms and the effectiveness of Bivalent (HPV-16/-18) and Quadrivalent (HPV-6/-11/-16/-18) HPV vaccine cross-protection, focusing on the critical aspects and the potential biases in clinical trials, in order to understand how cross-protection could impact on clinical outcomes and on the new perspectives in post-vaccine era. Copyright © 2013 Elsevier Inc. All rights reserved.

  17. The Risks and Benefits of Cannabis in the Dermatology Clinic.

    Science.gov (United States)

    Dhadwal, Gurbir; Kirchhof, Mark G

    2017-10-01

    Cannabis ( Cannabis sativa/indica), also known as marijuana, has been used for medicinal and recreational purposes for millennia. There has been a recent trend to legalize the use of cannabis, as illustrated by the recent legalization votes in numerous states in the United States and legislation in Canada to allow recreational cannabis use. With this increasing consumption of cannabis, dermatologists will see increased pressure to prescribe cannabis and will see the side effects of cannabis use with greater frequency. There are several approved medical indications for cannabis use, including psoriasis, lupus, nail-patella syndrome, and severe pain. In addition, very preliminary studies have suggested cannabis and its derivatives might have use in acne, dermatitis, pruritus, wound healing, and skin cancer. Further well-controlled studies are required to explore these potential uses. Conversely, the side effects of cannabis use are relatively well documented, and dermatologists should be aware of these presentations. Side effects of cannabis use include cannabis allergy manifesting as urticaria and pruritus, cannabis arteritis presenting with necrosis and ulcers, and oral cancers from cannabis smoke. In this review, we summarize some of the studies and reports regarding the medicinal uses of cannabis in the dermatology clinic and some of the side effects that might present more often to dermatologists as the use of cannabis increases.

  18. Benefits of Group Singing for People with Eating Disorders: Preliminary Findings from a Non-Clinical Study

    Directory of Open Access Journals (Sweden)

    Metaxia Pavlakou

    2009-01-01

    Full Text Available The purpose of this study is to examine the possible benefits of participation in group singing for people with eating disorders in a non-clinical context. The creation of a group singing workshop for women that exhibited disordered eating provided the opportunity to explore the participants’ experiences as perceived by them. A qualitative approach utilizing a semi-structured interview was employed to explore in depth the women’s perceptions regarding the group singing workshop. A thematic analysis of the data identified four main categories concerning the benefits of group singing for the population under study. The theoretical model of Sears (1968 of the processes in music therapy and its application on anorexic clients (Parente 1989 informed the discussion of the empirical findings.

  19. Comparing multiple competing interventions in the absence of randomized trials using clinical risk-benefit analysis

    Directory of Open Access Journals (Sweden)

    Lazo-Langner Alejandro

    2012-01-01

    Full Text Available Abstract Background To demonstrate the use of risk-benefit analysis for comparing multiple competing interventions in the absence of randomized trials, we applied this approach to the evaluation of five anticoagulants to prevent thrombosis in patients undergoing orthopedic surgery. Methods Using a cost-effectiveness approach from a clinical perspective (i.e. risk benefit analysis we compared thromboprophylaxis with warfarin, low molecular weight heparin, unfractionated heparin, fondaparinux or ximelagatran in patients undergoing major orthopedic surgery, with sub-analyses according to surgery type. Proportions and variances of events defining risk (major bleeding and benefit (thrombosis averted were obtained through a meta-analysis and used to define beta distributions. Monte Carlo simulations were conducted and used to calculate incremental risks, benefits, and risk-benefit ratios. Finally, net clinical benefit was calculated for all replications across a range of risk-benefit acceptability thresholds, with a reference range obtained by estimating the case fatality rate - ratio of thrombosis to bleeding. Results The analysis showed that compared to placebo ximelagatran was superior to other options but final results were influenced by type of surgery, since ximelagatran was superior in total knee replacement but not in total hip replacement. Conclusions Using simulation and economic techniques we demonstrate a method that allows comparing multiple competing interventions in the absence of randomized trials with multiple arms by determining the option with the best risk-benefit profile. It can be helpful in clinical decision making since it incorporates risk, benefit, and personal risk acceptance.

  20. Extending the theoretical framework for curriculum integration in pre-clinical medical education

    DEFF Research Database (Denmark)

    Vergel, John; Stentoft, Diana; Montoya, Juny

    2017-01-01

    INTRODUCTION: Curriculum integration is widely discussed in medical education but remains ill defined. Although there is plenty of information on logistical aspects of curriculum integration, little attention has been paid to the contextual issues that emerge from its practice and may complicate...... at Aalborg University. We observed various learning activities focused on pre-clinical education. Inspired by grounded theory, we analyzed the information we gathered. RESULTS: The following theoretical constructs emerged after the inductive analysis: 1) curriculum integration complexity is embedded...

  1. Do Contemporary Randomized Controlled Trials Meet ESMO Thresholds for Meaningful Clinical Benefit?

    Science.gov (United States)

    Del Paggio, J C; Azariah, B; Sullivan, R; Hopman, W M; James, F V; Roshni, S; Tannock, I F; Booth, C M

    2017-01-01

    The European Society for Medical Oncology (ESMO) recently released a magnitude of clinical benefit scale (ESMO-MCBS) for systemic therapies for solid cancers. Here, we evaluate contemporary randomized controlled trials (RCTs) against the proposed ESMO thresholds for meaningful clinical benefit. RCTs evaluating systemic therapy for breast cancer, nonsmall cell lung cancer (NSCLC), colorectal cancer (CRC), and pancreatic cancer published 2011-2015 were reviewed. Data were abstracted regarding trial characteristics and outcomes, and these were applied to the ESMO-MCBS. We also determined whether RCTs were designed to detect an effect that would meet clinical benefit as defined by the ESMO-MCBS. About 277 eligible RCTs were included (40% breast, 31% NSCLC, 22% CRC, 6% pancreas). Median sample size was 532 and 83% were funded by industry. Among all 277 RCTs, the experimental therapy was statistically superior to the control arm in 138 (50%) trials: results of only 31% (43/138) of these trials met the ESMO-MCBS clinical benefit threshold. RCTs with curative intent were more likely to meet clinically meaningful thresholds than those with palliative intent [61% (19/31) versus 22% (24/107), P meet ESMO-MCBS thresholds. Less than one-third of contemporary RCTs with statistically significant results meet ESMO thresholds for meaningful clinical benefit, and this represents only 15% of all published trials. Investigators, funding agencies, regulatory agencies, and industry should adopt more stringent thresholds for meaningful benefit in the design of future RCTs.

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

    Science.gov (United States)

    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.

  3. Clinical supervision with community Macmillan nurses: some theoretical suppositions and case work reports.

    Science.gov (United States)

    Jones, A

    1998-03-01

    This paper explores clinical supervision undertaken with community Macmillan Clinical Nurse Specialists in the UK. The philosophical motor is embedded in a Heideggerian existential-phenomenological framework, influenced by psychoanalytical thinking as described by Yalom. The discussion is derived from a qualitative research study designed to reach the lived-experience of five Macmillan Clinical Nurse Specialists. The author explores, in context, issues related to authenticity and project. Ideas are linked to contemporary concerns with reflective practice. The recommendation of this paper is that clinical supervision, through whatever method, reaches the vital experience of nursing practice. Realising tacit knowledge has potential to inform professional practice through powerful synergies of theoretical ways, understanding and lived experience. In addition, nurses might attain the existential idea of a boundary experience and so identify constructive ways to address issues arising out of professional practice.

  4. Experiences of using the Theoretical Domains Framework across diverse clinical environments: a qualitative study.

    Science.gov (United States)

    Phillips, Cameron J; Marshall, Andrea P; Chaves, Nadia J; Jankelowitz, Stacey K; Lin, Ivan B; Loy, Clement T; Rees, Gwyneth; Sakzewski, Leanne; Thomas, Susie; To, The-Phung; Wilkinson, Shelley A; Michie, Susan

    2015-01-01

    The Theoretical Domains Framework (TDF) is an integrative framework developed from a synthesis of psychological theories as a vehicle to help apply theoretical approaches to interventions aimed at behavior change. This study explores experiences of TDF use by professionals from multiple disciplines across diverse clinical settings. Mixed methods were used to examine experiences, attitudes, and perspectives of health professionals in using the TDF in health care implementation projects. Individual interviews were conducted with ten health care professionals from six disciplines who used the TDF in implementation projects. Deductive content and thematic analysis were used. Three main themes and associated subthemes were identified including: 1) reasons for use of the TDF (increased confidence, broader perspective, and theoretical underpinnings); 2) challenges using the TDF (time and resources, operationalization of the TDF) and; 3) future use of the TDF. The TDF provided a useful, flexible framework for a diverse group of health professionals working across different clinical settings for the assessment of barriers and targeting resources to influence behavior change for implementation projects. The development of practical tools and training or support is likely to aid the utility of TDF.

  5. SRS-22R Minimum Clinically Important Difference and Substantial Clinical Benefit After Adult Lumbar Scoliosis Surgery.

    Science.gov (United States)

    Carreon, Leah Y; Kelly, Michael P; Crawford, Charles H; Baldus, Christine R; Glassman, Steven D; Shaffrey, Christopher I; Bridwell, Keith H

    2018-01-01

    Longitudinal cohort. To determine if the minimum clinically important difference (MCID) and substantial clinical benefit (SCB) thresholds for the Scoliosis Research Society-22R (SRS22R) domains in patients with degenerative lumbar scoliosis are similar to those in patients with adult spinal deformity (ASD) with fusions extending into the thoracic spine. The MCID and SCB thresholds for the SRS22R domains in patients with ASD and adolescent idiopathic scoliosis have been reported. Patients enrolled in the NIH-sponsored Adult Symptomatic Lumbar Scoliosis (ASLS) trial who underwent surgery and completed the SRS22R preoperative and the SRS30 one-year postoperative were identified. One-year postoperative answers to the last eight questions of the SRS30 were used as anchors to determine the MCID and SCB for the Pain, Appearance, and Activity domains, and the Subscore and Total score using receiver operating characteristic (ROC) curve analysis. The sample population consisted of 147 patients. A total of 132 (89%) were females with a mean age of 59.4 years. There was a statistically significant improvement in all SRS22R scores from preoperative to one-year postoperative. There was also a statistically significant difference in domain scores among the different responses to the anchors. According to the ROC analysis, MCID was 1.17 for Appearance, 0.40 for Activity, 0.60 for Pain, 0.53 for Subscore, and 0.77 for Total; and SCB was 1.67 for Appearance, 0.60 for Activity, 0.62 for Subscore, and 1.11 for Total score. These are similar to previous reports of MCID and SCB thresholds for ASD patients who underwent fusion to the thoracic spine. The MCID and SCB thresholds for the SRS22R domains in patients with adult symptomatic lumbar scoliosis are very similar to the threshold values previously reported for adult deformity patients. Level II. Copyright © 2017 Scoliosis Research Society. Published by Elsevier Inc. All rights reserved.

  6. Designing m-learning for junior registrars--activation of a theoretical model of clinical knowledge.

    Science.gov (United States)

    Kanstrup, Anne Marie; Boye, Niels; Nøhr, Christian

    2007-01-01

    The MINI-project aims at supporting junior registrars in the learning process of how to utilize their theoretical knowledge from Medical School in everyday clinical reasoning and practice. Due to the nature of the work--concurrent moving, learning and producing--we designed an m-learning application. This paper introduces the possibilities and challenges for design of the m-learning application based on a) analytical findings on learning and mobility as derived from the design case--an emergency medical ward b) theoretical perspectives on medical knowledge, and c) presentation of the design of an m-learning application. The design process was based on user-driven innovation and the paper discusses considerations on how to combine user-drive and generic models.

  7. A justice-theoretic approach to the distribution of transportation benefits: Implications for transportation planning practice in the United States

    NARCIS (Netherlands)

    Martens, C.J.C.M.; Golub, A.; Robinson, G.

    2012-01-01

    Transportation improvements inevitably lead to an uneven distribution of user benefits, in space and by network type (private and public transport). This paper makes a moral argument for what would be a fair distribution of these benefits. The argument follows Walzer’s ‘‘Spheres of Justice’’

  8. Are supervisors using theoretical perspectives in their work? A descriptive survey among Swedish-approved clinical supervisors.

    Science.gov (United States)

    Berg, Agneta; Kisthinios, Marianne

    2007-11-01

    The aim of the study was to explore the theoretical perspectives in use by approved clinical nursing supervisors in Sweden. For the time being, we know little of the theoretical perspectives in use on a daily basis by the clinical nursing supervisors in Sweden. A questionnaire (n = 49) and follow-up telephone interviews (n = 14) were used. Data analysis was made by descriptive statistics and qualitative content analysis. The result from the questionnaire showed that the supervisors often used and combined different theoretical perspectives with origins in nursing, education and psychology. Surprisingly, one-fourth of the respondents did not state any nursing theoretical perspective in use during clinical nursing supervision. The result from the interviews revealed that the theory of Katie Eriksson (1987) was the most commonly used nursing perspective. As the overall aim for clinical nursing supervision is to improve nursing for the patient/family, the supervisor's competence in nursing is essential. Given this fact, and that only three-quarters of the approved clinical nursing supervisors stated a use of theoretical nursing perspective when supervising, there is obviously a need for further investigations in this area. In addition, there is also a need for approved Swedish clinical nursing supervisors, to further become aware of the theoretical perspective in use that supports their clinical nursing supervision. Clinical nursing supervision is a multifaceted activity that needs to be supported by different nursing theoretical perspectives including physical, emotional, intellectual, spiritual as well as socio-cultural aspects.

  9. [Autism and infantile psychosis. Theoretical and clinical contributions of the psychoanalysis].

    Science.gov (United States)

    Fendrik, Silvia

    2005-01-01

    This article describes the different theories of various authors that have tried to explain, from the psychoanalytic theory, the early childhood autistic disorder described by Leo Kanner in 1943. Autism differs from other childhood disorders and is characterized by a significant disconnection. This article sustains that there are two different lines of thought. One that explains the disorder as a regression during a normal phase of development; and the other as an early defense in response to extreme situations. These two theories are present in all the current considerations about autism as a theoretical debate that goes beyond the clinical observation and determines the direction of the cure.

  10. [Resource activation in clinical psychology and psychotherapy: review of theoretical issues and current research].

    Science.gov (United States)

    Groß, L J; Stemmler, M; de Zwaan, M

    2012-08-01

    This review summarises theoretical issues and current research on working with clients' resources and strengths in clinical psychology and psychotherapy. Resource activation is considered as an important common factor in psychotherapy. In general, resource activation means an explicit focus on resources, strengths and potentials of the clients. After defining the term resources, considerations with regard to therapeutic attitude, principles of resource activation, approaches to resource diagnostics and different research strategies are presented. Current research focuses especially on the relation between resource activation and process variables in out-patient treatment. © Georg Thieme Verlag KG Stuttgart · New York.

  11. ESMO - Magnitude of Clinical Benefit Scale V.1.0 questions and answers.

    Science.gov (United States)

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

    2016-01-01

    The ESMO Magnitude of Clinical Benefit Scale (ESMO-MCBS) is a standardised, generic, validated tool to stratify the magnitude of clinical benefit that can be anticipated from anticancer therapies. The ESMO-MCBS is intended to both assist oncologists in explaining the likely benefits of a particular treatment to their patients as well as to aid public health decision makers' prioritise therapies for reimbursement. From its inception the ESMO-MCBS Working Group has invited questions and critiques to promote understanding and to address misunderstandings regarding the nuanced use of the scale, and to identify shortcomings in the scale to be addressed in future planned revisions and updates. The ESMO-MCBS V.1.0 has attracted many questions regarding its development, structure and potential applications. These questions, together with responses from the ESMO-MCBS Working Group, have been edited and collated, and are herein presented as a supplementary resource.

  12. A counterfactual p-value approach for benefit-risk assessment in clinical trials.

    Science.gov (United States)

    Zeng, Donglin; Chen, Ming-Hui; Ibrahim, Joseph G; Wei, Rachel; Ding, Beiying; Ke, Chunlei; Jiang, Qi

    2015-01-01

    Clinical trials generally allow various efficacy and safety outcomes to be collected for health interventions. Benefit-risk assessment is an important issue when evaluating a new drug. Currently, there is a lack of standardized and validated benefit-risk assessment approaches in drug development due to various challenges. To quantify benefits and risks, we propose a counterfactual p-value (CP) approach. Our approach considers a spectrum of weights for weighting benefit-risk values and computes the extreme probabilities of observing the weighted benefit-risk value in one treatment group as if patients were treated in the other treatment group. The proposed approach is applicable to single benefit and single risk outcome as well as multiple benefit and risk outcomes assessment. In addition, the prior information in the weight schemes relevant to the importance of outcomes can be incorporated in the approach. The proposed CPs plot is intuitive with a visualized weight pattern. The average area under CP and preferred probability over time are used for overall treatment comparison and a bootstrap approach is applied for statistical inference. We assess the proposed approach using simulated data with multiple efficacy and safety endpoints and compare its performance with a stochastic multi-criteria acceptability analysis approach.

  13. ORIGINAL ARTICLE PACS: Do clinical users benefit from it as a ...

    African Journals Online (AJOL)

    African) setting, advances in the expansion, assessment and refinement of digitised archiving systems in developed countries are at the forefront of current radiological and information technology research. PACS: Do clinical users benefit from it as a training adjunct? Jolandi van Heerden, MB ChB. Zarina Lockhat, MB ChB, ...

  14. 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)

    NARCIS (Netherlands)

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

    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

  15. Effect modification, interaction and mediation: an overview of theoretical insights for clinical investigators

    Directory of Open Access Journals (Sweden)

    Corraini P

    2017-06-01

    Full Text Available Priscila Corraini,1 Morten Olsen,1 Lars Pedersen,1 Olaf M Dekkers,1,2 Jan P Vandenbroucke1–3 1Department of Clinical Epidemiology, Institute of Clinical Medicine, Aarhus University Hospital, Aarhus, Denmark; 2Leiden University Medical Center, Leiden, the Netherlands; 3Department of Epidemiology and Population Health, London School of Hygiene and Tropical Medicine, London, UK Abstract: We revisited the three interrelated epidemiological concepts of effect modification, interaction and mediation for clinical investigators and examined their applicability when using research databases. The standard methods that are available to assess interaction, effect modification and mediation are explained and exemplified. For each concept, we first give a simple “best-case” example from a randomized controlled trial, followed by a structurally similar example from an observational study using research databases. Our explanation of the examples is based on recent theoretical developments and insights in the context of large health care databases. Terminology is sometimes ambiguous for what constitutes effect modification and interaction. The strong assumptions underlying the assessment of interaction, and particularly mediation, require clinicians and epidemiologists to take extra care when conducting observational studies in the context of health care databases. These strong assumptions may limit the applicability of interaction and mediation assessments, at least until the biases and limitations of these assessments when using large research databases are clarified. Keywords: methods, epidemiology, effect modifiers, stratified analyses, health care administrative claims

  16. Fear of cancer recurrence: a theoretical review and its relevance for clinical presentation and management.

    Science.gov (United States)

    Simonelli, Laura E; Siegel, Scott D; Duffy, Nicole M

    2017-10-01

    There is increasing recognition of the unique physical and psychosocial concerns of the growing population of cancer survivors. An emerging literature demonstrates that fear of cancer recurrence (FCR) is a problematic long-term and late effect for cancer survivors. In fact, FCR is a top concern, and this article provides a necessary synthesis of the extant research evidence and theory. Literature searches were conducted using databases including MEDLINE and PsychINFO using specified search terms including 'fear of recurrence' and 'worry about recurrence'. A comprehensive narrative review summarizes early empirical findings on FCR including current definitions, assessment tools, clinical presentations, quality of life impact, prevalence, trajectory and risk factors. This paper also critically reviews the relevant theoretical frameworks to best understand these findings and considers multiple psychosocial treatment models that may have relevance for addressing FCR in the clinical setting. There is evidence of substantial prevalence and quality of life impact of FCR. Several theories (e.g. self-regulation model of illness, a family-based model, uncertainty in illness theory, social-cognitive processing theory, terror management theory) directly or indirectly help conceptualize FCR and inform potential treatment options for those with clinically significant distress or impairment resulting from FCR. Further investigation into FCR is warranted to promote evidence-based care for this significant cancer survivorship concern. Copyright © 2016 John Wiley & Sons, Ltd.

  17. Experiences of using the Theoretical Domains Framework across diverse clinical environments: a qualitative study

    Directory of Open Access Journals (Sweden)

    Phillips CJ

    2015-03-01

    Full Text Available Cameron J Phillips,1,2 Andrea P Marshall,3,4 Nadia J Chaves,5 Stacey K Jankelowitz,6,7 Ivan B Lin,8 Clement T Loy,9,10 Gwyneth Rees,11 Leanne Sakzewski,12 Susie Thomas,13,14 The-Phung To,15 Shelley A Wilkinson,16,17 Susan Michie18 1Division of Pharmacy, Flinders Medical Centre, Bedford Park, SA, Australia; 2School of Medicine, Flinders University, Adelaide, SA, Australia; 3Centre for Health Practice Innovation, Griffith Health Institute, Griffith University, Southport, QLD, Australia; 4Gold Coast University Hospital, Southport, QLD, Australia; 5Victorian Infectious Diseases Service, Royal Melbourne Hospital, Parkville, VIC, Australia; 6Central Clinical School, Sydney Medical School, University of Sydney, 7Institute of Neurosciences, Royal Prince Alfred Hospital, Sydney, NSW, Australia; 8Western Australian Centre for Rural Health, University of Western Australia, Geraldton, WA, Australia; 9School of Public Health, Sydney Medical School, University of Sydney, Sydney, NSW, Australia; 10Huntington Diseases Centre, Westmead Hospital, Westmead, NSW, Australia; 11Centre for Eye Research Australia, University of Melbourne, Royal Victorian Eye and Ear Hospital, Melbourne, VIC, Australia; 12Queensland Cerebral Palsy and Rehabilitation Research Centre, University of Queensland, Brisbane, QLD, Australia; 13Physiotherapy Department, Flinders Medical Centre, Bedford Park, SA, Australia; 14International Centre for Allied Health Evidence (iCAHE, School of Health Sciences, University of South Australia, Adelaide, SA, Australia; 15Pharmacy Department, Austin Health, Heidelberg, VIC, Australia; 16Mater Research Institute, The University of Queensland, South Brisbane, QLD, Australia; 17Department of Nutrition and Dietetics, Mater Health Services, South Brisbane, QLD, Australia; 18University College London Centre for Behaviour Change, Department of Clinical, Educational and Health Psychology, University College, London, UK Background: The Theoretical Domains

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

    Science.gov (United States)

    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. © The Author(s) 2015.

  19. Clinical Data Acquisition Standards Harmonization importance and benefits in clinical data management.

    Science.gov (United States)

    Gaddale, Jagadeeswara Rao

    2015-01-01

    In the clinical trial process, precise and concise data collection at the source is imperative and requires statistical analysis to be performed to derive the primary and secondary endpoints. The quality of raw data collection has a direct impact on the statistical outputs generated as per the statistical analysis plan. Hence, the data collection tools used for data transcription must be clear, understandable, and precise, which helps the investigator to provide the accurate subject data. Clinical Data Acquisition Standards Harmonization (CDASH) provides guidance to develop the case report form (CRF) for domains that are commonly used for the majority of the clinical trials across the therapeutic areas. This white paper describes the importance of CDASH standards, its advantages and its impact on the efforts and the cost in designing the CRF.

  20. Clinical data acquisition standards harmonization importance and benefits in clinical data management

    Directory of Open Access Journals (Sweden)

    Jagadeeswara Rao Gaddale

    2015-01-01

    Full Text Available In the clinical trial process, precise and concise data collection at the source is imperative and requires statistical analysis to be performed to derive the primary and secondary endpoints. The quality of raw data collection has a direct impact on the statistical outputs generated as per the statistical analysis plan. Hence, the data collection tools used for data transcription must be clear, understandable, and precise, which helps the investigator to provide the accurate subject data. Clinical Data Acquisition Standards Harmonization (CDASH provides guidance to develop the case report form (CRF for domains that are commonly used for the majority of the clinical trials across the therapeutic areas. This white paper describes the importance of CDASH standards, its advantages and its impact on the efforts and the cost in designing the CRF.

  1. Use of online clinical videos for clinical skills training for medical students: benefits and challenges.

    Science.gov (United States)

    Jang, Hye Won; Kim, Kyong-Jee

    2014-03-21

    Multimedia learning has been shown effective in clinical skills training. Yet, use of technology presents both opportunities and challenges to learners. The present study investigated student use and perceptions of online clinical videos for learning clinical skills and in preparing for OSCE (Objective Structured Clinical Examination). This study aims to inform us how to make more effective us of these resources. A mixed-methods study was conducted for this study. A 30-items questionnaire was administered to investigate student use and perceptions of OSCE videos. Year 3 and 4 students from 34 Korean medical schools who had access to OSCE videos participated in the online survey. Additionally, a semi-structured interview of a group of Year 3 medical students was conducted for an in-depth understanding of student experience with OSCE videos. 411 students from 31 medical schools returned the questionnaires; a majority of them found OSCE videos effective for their learning of clinical skills and in preparing for OSCE. The number of OSCE videos that the students viewed was moderately associated with their self-efficacy and preparedness for OSCE (p students reported lack of integration into the curriculum and lack of interaction as barriers to more effective use of OSCE videos. The present study confirms the overall positive impact of OSCE videos on student learning of clinical skills. Having faculty integrate these learning resources into their teaching, integrating interactive tools into this e-learning environment to foster interactions, and using mobile devices for convenient access are recommended to help students make more effective use of these resources.

  2. Benefits and challenges of international clinical education from a US-based physiotherapist faculty perspective.

    Science.gov (United States)

    Pechak, Celia; Black, Jill D

    2013-12-01

    The influence of internationalization on physiotherapist education in at least North American-based programmes has become more apparent. Faculty and students have been involved in various international activities. One category of activities includes international clinical education (ICE), where students earn clinical education credit for their learning activities at international sites. Although this educational strategy appears to be increasingly used in at least the United States and Canada, the related literature is limited in scope. The purpose of this portion of the present study was to investigate the benefits and challenges of ICE for US-based students, US-based physiotherapy programmes and international partners from the perspective of US-based faculty sending students for clinical education internationally. Content analysis was used for this qualitative study. Fifteen US-based faculty members who had experience in sending physiotherapist students for ICE were recruited. The primary researcher conducted semi-structured phone interviews, averaging approximately 60 minutes in length. The primary and secondary researchers completed data analysis using NVivo 8 software (QSR International Inc., Cambridge, MA). Benefits of ICE to the students included exposure to alternate health systems, broadening of student perspectives and clinical competence. Challenges consisted of funding and possible language barrier. Increased visibility, expanded global perspective and faculty collaborations were benefits to the programme. Ensuring a quality learning experience was the greatest programme challenge. Benefits to the international site included education and faculty collaborations/exchanges; challenges were language, student clinical preparation and unfamiliarity with the student evaluation tool. Because the sample was limited to 15 US-based faculty members, the results may not be relevant to all programmes inside or outside of the United States. Additionally, the study

  3. Group-based interpersonal psychotherapy for posttraumatic stress disorder: theoretical and clinical aspects.

    Science.gov (United States)

    Robertson, Michael; Rushton, Paul J; Bartrum, Dee; Ray, Rebecca

    2004-04-01

    Posttraumatic stress disorder (PTSD) is a condition that engenders both symptomatic distress and severe disruption in interpersonal and social functioning. Most of the empirical research on treatment has emphasized interventions that aim to alleviate the symptoms of PTSD, despite the persisting impairments in social, occupational, and interpersonal functioning. In clinical practice, achieving relief from symptoms such as irritability or phobic avoidance is a worthwhile goal, yet significant distress and disability derived from disruptions to interpersonal attachments, social networks, and confiding intimate relationships persist. Interpersonal psychotherapy (IPT) has been shown to be efficacious in research settings for depression and eating disorders, in both group and individual formats. Recent pilot data also suggests the potential usefulness of IPT in anxiety disorders. The aim of this paper is to provide a rationale for the use of group-based IPT as an intervention for PTSD as part of a management package, arguing from theoretical and clinical viewpoints. The integration of IPT therapeutic processes with the therapeutic group process is discussed, and a detailed case discussion is presented as an illustration.

  4. Precepting and symbolic interactionism--a theoretical look at preceptorship during clinical practice.

    Science.gov (United States)

    Carlson, Elisabeth

    2013-02-01

    To present a discussion of precepting through the use of symbolic interactionism as exemplified by findings from an ethnographic study. It is a well-known fact that clinical practice, where students are supervised by precepting nurses, is an important part of nursing education. Several previous studies have stressed the vital role preceptors have for the development of student nurses' clinical competence. Despite this, few of these findings are discussed from a theoretical standpoint to further explain and illustrate the complexity of preceptorship. This article builds on findings from an ethnographic study undertaken between November 2006-May 2007 and again between March-September 2009. Full details of the empirical findings have been reported elsewhere. Precepting can be understood as a trusting relationship between preceptor and student interacting and sharing nursing activities. The participants' actions will influence and shape the meaning and understanding of these activities. Precepting is a complex and advanced role for nurses that they need to be properly prepared for. Thus, preceptor preparation needs to be organized in collaboration between healthcare organizations and universities. It is suggested that preceptor preparation programmes should focus on reflection, critical thinking and communication skills. Symbolic interactionism can serve as a potential theory that will expand the understanding of and give new perspectives of nursing practice. It would therefore be encouraging to see further testing of suitable theories to interpret empirical findings and create opportunities for practice improvement. © 2012 Blackwell Publishing Ltd.

  5. Inflammation and autoantibody markers identify rheumatoid arthritis patients with enhanced clinical benefit following rituximab treatment.

    Science.gov (United States)

    Lal, Preeti; Su, Zheng; Holweg, Cecile T J; Silverman, Gregg J; Schwartzman, Sergio; Kelman, Ariella; Read, Simon; Spaniolo, Greg; Monroe, John G; Behrens, Timothy W; Townsend, Michael J

    2011-12-01

    Rituximab significantly improves the signs and symptoms of rheumatoid arthritis (RA) and slows the progression of joint damage. The aim of this study was to identify clinical characteristics and biomarkers that identify patients with RA in whom the clinical benefit of rituximab may be enhanced. The study group comprised 1,008 RA patients from 2 independent randomized placebo-controlled phase III clinical trials (REFLEX [Randomized Evaluation of Long-Term Efficacy of Rituximab in Rheumatoid Arthritis] and SERENE [Study Evaluating Rituximab's Efficacy in Methotrexate Inadequate Responders]). A novel threshold selection method was used to identify baseline candidate biomarkers present in at least 20% of patients that enriched for placebo-corrected American College of Rheumatology 50% improvement (ACR50 response; a high clinical efficacy bar) at week 24 after the first course of rituximab. The presence of IgM rheumatoid factor (IgM-RF), IgG-RF, IgA-RF, and IgG anti-cyclic citrullinated peptide (anti-CCP) antibodies together with an elevated C-reactive protein (CRP) level were associated with enhanced placebo-corrected ACR50 response rates in the REFLEX patients with RA who had an inadequate response to anti-tumor necrosis factor therapies. These findings were independently replicated using samples from patients in SERENE who had an inadequate response to disease-modifying antirheumatic drug treatment. The combination of an elevated baseline CRP level together with an elevated level of any RF isotype and/or IgG anti-CCP antibodies was further associated with an enhanced benefit to rituximab. The presence of any RF isotype and/or IgG anti-CCP autoantibodies together with an elevated CRP level identifies a subgroup of patients with RA in whom the benefit of rituximab treatment may be enhanced. Although the clinical benefit of rituximab was greater in the biomarker-positive population compared with the biomarker-negative population, the clinical benefit of rituximab

  6. Hypothesis: atorvastatin has pleiotropic effects that translate into early clinical benefits on cardiovascular disease.

    Science.gov (United States)

    Novela, Cristina; Hennekens, Charles H

    2004-03-01

    The results of numerous long-term, randomized trials show that statins significantly decrease the risks of myocardial infarction, stroke, and vascular death as well as total mortality. The benefits of statins on cardiovascular disease in patients who are not experiencing acute coronary syndromes generally become apparent only after about 2 years. In contrast, atorvastatin conferred an early clinical benefit in the lipid-lowering arm of the long-term Anglo Scandinavian Cardiac Outcomes Trial as well as early benefit on progression of atherosclerosis in the Reversal of Atherosclerosis with Aggressive Lipid Lowering trial. An unexpected finding at baseline in the prospective Interaction of Atorvastatin and Clopidogrel Study was that patients on atorvastatin had significantly decreased platelet activity compared with either patients on other statins or those taking no statins. Atorvastatin has protective effects against membrane lipid peroxidation at pharmacologic concentrations. These and other considerations contribute to the hypothesis that atorvastatin has pleiotropic effects that translate into early clinical benefits on cardiovascular disease.

  7. Multi-armed Bandit Models for the Optimal Design of Clinical Trials: Benefits and Challenges.

    Science.gov (United States)

    Villar, Sofía S; Bowden, Jack; Wason, James

    Multi-armed bandit problems (MABPs) are a special type of optimal control problem well suited to model resource allocation under uncertainty in a wide variety of contexts. Since the first publication of the optimal solution of the classic MABP by a dynamic index rule, the bandit literature quickly diversified and emerged as an active research topic. Across this literature, the use of bandit models to optimally design clinical trials became a typical motivating application, yet little of the resulting theory has ever been used in the actual design and analysis of clinical trials. To this end, we review two MABP decision-theoretic approaches to the optimal allocation of treatments in a clinical trial: the infinite-horizon Bayesian Bernoulli MABP and the finite-horizon variant. These models possess distinct theoretical properties and lead to separate allocation rules in a clinical trial design context. We evaluate their performance compared to other allocation rules, including fixed randomization. Our results indicate that bandit approaches offer significant advantages, in terms of assigning more patients to better treatments, and severe limitations, in terms of their resulting statistical power. We propose a novel bandit-based patient allocation rule that overcomes the issue of low power, thus removing a potential barrier for their use in practice.

  8. When Veterinarians Support Canine Therapy: Bidirectional Benefits for Clinics and Therapy Programs

    Directory of Open Access Journals (Sweden)

    John-Tyler Binfet

    2018-01-01

    Full Text Available This paper proposes a mutually beneficial model of collaboration between veterinarians and canine therapy programs. Veterinarians and the clinics for whom they work routinely establish collaborations with multiple and varied stakeholders. This might include a laboratory for processing samples and the corresponding courier company needed to deliver samples to the lab or a partnership with a local dog rescue organization for whom discounted rates are offered. One community partnership that stands to benefit both the clinic and the community agency, is for veterinarians to work in tandem with a local canine-assisted therapy program. The benefits to such an alliance are multifold and address aspects of veterinary medicine including client recruitment, community education, and access to a network of devoted dog enthusiasts.

  9. Robust Intensity Modulated Proton Therapy (IMPT Increases Estimated Clinical Benefit in Head and Neck Cancer Patients.

    Directory of Open Access Journals (Sweden)

    Lisanne V van Dijk

    Full Text Available To compare the clinical benefit of robust optimized Intensity Modulated Proton Therapy (minimax IMPT with current photon Intensity Modulated Radiation Therapy (IMRT and PTV-based IMPT for head and neck cancer (HNC patients. The clinical benefit is quantified in terms of both Normal Tissue Complication Probability (NTCP and target coverage in the case of setup and range errors.For 10 HNC patients, PTV-based IMRT (7 fields, minimax and PTV-based IMPT (2, 3, 4, 5 and 7 fields plans were tested on robustness. Robust optimized plans differed from PTV-based plans in that they target the CTV and penalize possible error scenarios, instead of using the static isotropic CTV-PTV margin. Perturbed dose distributions of all plans were acquired by simulating in total 8060 setup (±3.5 mm and range error (±3% combinations. NTCP models for xerostomia and dysphagia were used to predict the clinical benefit of IMPT versus IMRT.The robustness criterion was met in the IMRT and minimax IMPT plans in all error scenarios, but this was only the case in 1 of 40 PTV-based IMPT plans. Seven (out of 10 patients had relatively large NTCP reductions in minimax IMPT plans compared to IMRT. For these patients, xerostomia and dysphagia NTCP values were reduced by 17.0% (95% CI; 13.0-21.1 and 8.1% (95% CI; 4.9-11.2 on average with minimax IMPT. Increasing the number of fields did not contribute to plan robustness, but improved organ sparing.The estimated clinical benefit in terms of NTCP of robust optimized (minimax IMPT is greater than that of IMRT and PTV-based IMPT in HNC patients. Furthermore, the target coverage of minimax IMPT plans in the presence of errors was comparable to IMRT plans.

  10. Mobile Learning in a Rural Medical School: Feasibility and Educational Benefits in Campus and Clinical Settings

    OpenAIRE

    Debra Nestel; Katherine Gray; Andre Ng; Matthew McGrail; George Kotsanas; Elmer Villanueva

    2014-01-01

    Students in a new medical school were provided with laptops. This study explored the feasibility and educational benefits of mobile learning for two cohorts of students learning in two settings—university campus (first-year students) and rural clinical placements (second-year students). Evaluation involved questionnaires, focus groups (faculty and students), and document analysis. Descriptive statistics were computed. Focus groups were audio-recorded, transcribed, and analysed thematically. R...

  11. Generating Evidence for Clinical Benefit of PET/CT in Diagnosing Cancer Patients

    DEFF Research Database (Denmark)

    Vach, Werner; Høilund-Carlsen, Poul Flemming; Gerke, Oke

    2011-01-01

    of PET/CT in cancer patients: replacement of an invasive procedure, improved accuracy of initial diagnosis, improved accuracy of staging for curative versus palliative treatment, improved accuracy of staging for radiation versus chemotherapy, response evaluation, and acceleration of clinical decisions...... to assess the benefit expected from the use of PET/CT. Only if decision modeling does not allow definitive conclusions should randomized controlled trials be planned....

  12. From benefits evaluation to clinical adoption: making sense of health information system success in Canada.

    Science.gov (United States)

    Lau, Francis; Price, Morgan; Keshavjee, Karim

    2011-01-01

    This article proposes a Clinical Adoption Framework for making sense of health information system (HIS) success in Canada. It extends Canada Health Infoway's Benefits Evaluation Framework with contextual factors that influence HIS adoption by clinicians, which include people, organization, implementation, and the macro environment. Our hypothesis is that successful clinical adoption of an HIS requires explicit recognition, strategies and actions that address the factors described in the framework. Validation of this framework by stakeholders and literature has thus far been favourable. Its potential application with selected evaluation approaches in specific settings, the implications and work ahead are discussed.

  13. Interleukin-10: potential benefits and possible risks in clinical infectious diseases.

    Science.gov (United States)

    Opal, S M; Wherry, J C; Grint, P

    1998-12-01

    Human interleukin-10 (IL-10) is a potent anti-inflammatory cytokine that inhibits the synthesis of the major proinflammatory cytokines and chemokines. IL-10 is the principal TH2-type cytokine that upregulates humoral immune responses and attenuates cell-mediated immune reactions. This cytokine has a number of immunomodulatory properties that might be clinically useful in a variety of inflammatory and infectious disease states. Clinical trials with human recombinant IL-10 are already in progress. Carefully selected patients with inflammatory conditions may benefit from IL-10 therapy if concomitant infectious diseases are recognized and treated appropriately.

  14. Fiber supplements and clinically proven health benefits: How to recognize and recommend an effective fiber therapy

    Science.gov (United States)

    Lambeau, Kellen V.

    2017-01-01

    Abstract Background Only 5% of adults consume the recommended level of dietary fiber. Fiber supplements appear to be a convenient and concentrated source of fiber, but most do not provide the health benefits associated with dietary fiber. Purpose This review will summarize the physical effects of isolated fibers in small and large intestines, which drive clinically meaningful health benefits. Data sources A comprehensive literature review was conducted (Scopus and PubMed) without limits to year of publication (latest date included: October 31, 2016). Conclusions The physical effects of fiber in the small intestine drive metabolic health effects (e.g., cholesterol lowering, improved glycemic control), and efficacy is a function of the viscosity of gel‐forming fibers (e.g., psyllium, β‐glucan). In the large intestine, fiber can provide a laxative effect if (a) it resists fermentation to remain intact throughout the large intestine, and (b) it increases percentage of water content to soften/bulk stool (e.g., wheat bran and psyllium). Implications for practice It is important for nurse practitioners to understand the underlying mechanisms that drive specific fiber‐related health benefits, and which fiber supplements have rigorous clinical data to support a recommendation. Clinical pearl For most fiber‐related beneficial effects, “Fiber needs to gel to keep your patients well.” PMID:28252255

  15. Global benefit-risk assessment in designing clinical trials and some statistical considerations of the method.

    Science.gov (United States)

    Pritchett, Yili Lu; Tamura, Roy

    2008-01-01

    When characterizing a therapy, the efficacy and the safety are two major aspects under consideration. In prescribing a therapy to a patient, a clinician puts the two aspects together and makes a decision based on a consolidated thought process. The global benefit-risk (GBR) measures proposed by Chuang-Stein et al. (Stat. Med. 1991; 10:1349-1359) are useful in facilitating the thinking, and creating the framework for making statistical comparisons based on benefit-risk point of view. This article describes how a GBR linear score was defined and used as the primary outcome measure in a clinical trial design. The robustness of the definitions of 'benefit' and 'risk' are evaluated using different criteria. The sensitivity of the pre-specified weights is also analyzed using alternative weights; one of those was determined by the relative to an identified distribution integral transformation approach (Biometrics 1958; 14:18-38). Statistical considerations are illustrated using pooled data from clinical trials studying antidepressant. The pros and cons for using GBR assessments in the setting of clinical trials are discussed.

  16. The m-Health revolution: Exploring perceived benefits of WhatsApp use in clinical practice.

    Science.gov (United States)

    Ganasegeran, Kurubaran; Renganathan, Pukunan; Rashid, Abdul; Al-Dubai, Sami Abdo Radman

    2017-01-01

    The dawn of m-Health facilitates new horizons of professional communication through WhatsApp, allowing health professionals to interact fast and efficiently for effective patient management. This preliminary study aimed to investigate perceived benefits, if any, of WhatsApp use across general medical and emergency teams during clinical practice in Malaysia. A cross-sectional study was conducted in a universal sample of 307 health professionals comprising of nurses, medical assistants, medical residents, medical officers and physicians across medical and casualty departments in a Malaysian public hospital. The self-administered questionnaire consisted of items on socio-demographics, WhatsApp usage characteristics and the type of communication events during clinical practice. The majority of respondents (68.4%) perceived WhatsApp as beneficial during clinical practice. In multivariate analysis, perceived benefits was significantly higher amongst the clinical management group (aOR=2.6, 95% CI 1.5-4.6, p=0.001), those using WhatsApp for >12months (aOR=1.7, 95% CI 1.0-3.0, p=0.047), those receiving response ≤15min to a new communication (aOR=1.9, 95% CI 1.1-3.2, p=0.017), and frequent information giving events (aOR=2.4, 95% CI 1.2-4.8, p=0.016). Perceived benefits of WhatsApp use in clinical practice was significantly associated with usage characteristics and type of communication events. This study lays the foundation for quality improvement innovations in patient management delivered through m-Health technology. Copyright © 2016 Elsevier Ireland Ltd. All rights reserved.

  17. Extending the theoretical framework for curriculum integration in pre-clinical medical education.

    Science.gov (United States)

    Vergel, John; Stentoft, Diana; Montoya, Juny

    2017-08-01

    Curriculum integration is widely discussed in medical education but remains ill defined. Although there is plenty of information on logistical aspects of curriculum integration, little attention has been paid to the contextual issues that emerge from its practice and may complicate students' knowledge integration. Therefore, we aimed to uncover how curriculum integration is manifested through context. We collected data from the official curriculum and interviewed ten participants (including curriculum designers, facilitators, and students) in the bachelor's medical program at Aalborg University. We observed various learning activities focused on pre-clinical education. Inspired by grounded theory, we analyzed the information we gathered. The following theoretical constructs emerged after the inductive analysis: 1) curriculum integration complexity is embedded in the institutional learning perspectives; 2) curriculum integration is used to harmonize conflicting learning perspectives in curriculum practice; 3) curriculum integration creates tensions that self-organize its structure; and 4) curriculum integration becomes visible in collaborative learning spaces. These constructs provide a framework for analyzing curriculum integration in the context in which it is meant to appear, which may assist educationalists to gain a more specific understanding of the term. This may enable effective curriculum integration since contextual issues are addressed in addition to the goals specified in the official curriculum.

  18. Risks and benefits of speech recognition for clinical documentation: a systematic review

    Science.gov (United States)

    2016-01-01

    Objective To review literature assessing the impact of speech recognition (SR) on clinical documentation. Methods Studies published prior to December 2014 reporting clinical documentation using SR were identified by searching Scopus, Compendex and Inspect, PubMed, and Google Scholar. Outcome variables analyzed included dictation and editing time, document turnaround time (TAT), SR accuracy, error rates per document, and economic benefit. Twenty-three articles met inclusion criteria from a pool of 441. Results Most studies compared SR to dictation and transcription (DT) in radiology, and heterogeneity across studies was high. Document editing time increased using SR compared to DT in four of six studies (+1876.47% to –16.50%). Dictation time similarly increased in three of five studies (+91.60% to –25.00%). TAT consistently improved using SR compared to DT (16.41% to 82.34%); across all studies the improvement was 0.90% per year. SR accuracy was reported in ten studies (88.90% to 96.00%) and appears to improve 0.03% per year as the technology matured. Mean number of errors per report increased using SR (0.05 to 6.66) compared to DT (0.02 to 0.40). Economic benefits were poorly reported. Conclusions SR is steadily maturing and offers some advantages for clinical documentation. However, evidence supporting the use of SR is weak, and further investigation is required to assess the impact of SR on documentation error types, rates, and clinical outcomes. PMID:26578226

  19. Net clinical benefit of new oral anticoagulants (dabigatran, rivaroxaban, apixaban) versus no treatment in a 'real world' atrial fibrillation population

    DEFF Research Database (Denmark)

    Banerjee, A; Lane, D A; Torp-Pedersen, C

    2012-01-01

    on patients with non-valvular AF between 1997-2008, for dabigatran, rivaroxaban and apixaban on the basis of recent clinical trial outcome data for these new OACs. In patients with CHADS2=0 but at high bleeding risk, apixaban and dabigatran 110 mg bid had a positive net clinical benefit. At CHA2DS2-VASc=1...... risk of stroke and thromboembolism gain the greatest benefit from OAC with warfarin. There are no data for the new OACs, that is, dabigatran, rivaroxaban and apixaban, as yet. We calculated the net clinical benefit balancing IS against ICH using data from the Danish National Patient Registry......, apixaban and both doses of dabigatran (110 mg and 150 mg bid) had a positive net clinical benefit. In patients with CHADS2 score=1 or CHA2DS2-VASc=2, the three new OACs (dabigatran, rivaroxaban and apixaban) appear superior to warfarin for net clinical benefit, regardless of risk of bleeding. When risk...

  20. Post graduate clinical placements: evaluating benefits and challenges with a mixed methods cross sectional design.

    Science.gov (United States)

    Yiend, Jenny; Tracy, Derek K; Sreenan, Brian; Cardi, Valentina; Foulkes, Tina; Koutsantoni, Katerina; Kravariti, Eugenia; Tchanturia, Kate; Willmott, Lucy; Shergill, Sukhi; Reedy, Gabriel

    2016-02-16

    Systematic evaluations of clinical placements are rare, especially when offered alongside academic postgraduate courses. An evidence-based approach is important to allow pedagogically-driven provision, rather than that solely governed by opinion or market demand. Our evaluation assessed a voluntary clinical placement scheme allied to a mental health course. Data were collected over academic years 2010/11- 2013/14, from participating students (n = 20 to 58) and clinician supervisors (n = 10-12), using a mixed-methods cross-sectional design. Quantitative evaluation captured information on uptake, dropout, resource use, attitudes and experience, using standardized (the Placement Evaluation Questionnaire; the Scale To Assess the Therapeutic Relationship - Clinical version and the University of Toronto Placement Supervisor Evaluation) and bespoke questionnaires and audit data. Qualitative evaluation comprised two focus groups (5 clinicians, 5 students), to investigate attitudes, experience, perceived benefits, disadvantages and desired future developments. Data were analysed using framework analysis to identify a priori and emergent themes. High uptake (around 70 placements per annum), low dropout (2-3 students per annum; 5 %) and positive focus group comments suggested placements successfully provided added value and catered sufficiently to student demand. Students' responses confirmed that placements met expectations and the perception of benefit remained after completion with 70 % (n = 14) reporting an overall positive experience, 75 % (n = 15) reporting a pleasant learning experience, 60 % (n = 12) feeling that their clinical skills were enhanced and 85 % (n = 17) believing that it would benefit other students. Placements contributed the equivalent of seven full time unskilled posts per annum to local health care services. While qualitative data revealed perceived 'mutual benefit' for both students and clinicians, this was qualified by

  1. A Case of Appendiceal Adenocarcinoma with Clinical Benefit from FOLFOX and Bevacizumab

    Directory of Open Access Journals (Sweden)

    Erin D. Powell

    2009-07-01

    Full Text Available A 44-year-old woman presented with lower abdominal pain and bilateral ovarian masses on ultrasound. Exploratory laparotomy revealed extensive peritoneal and intra-abdominal disease and an abnormal appendix. Bilateral salpingo-oophorectomy, infracolic omentectomy, ileocolic resection and primary anastomosis were performed. Final pathology revealed a primary appendiceal adenocarcinoma, poorly differentiated, of signet ring cell type. CT scan postoperatively revealed gross residual disease. The patient was treated with FOLFOX chemotherapy combined with bevacizumab. Repeat CT scan showed a decrease in residual disease and the patient clinically improved. After her treatment has been continued for 13 months, she remains clinically well and her CT scan shows sustained disease stability. Disseminated appendiceal carcinoma is generally considered to be refractory to 5-FU-based chemotherapy and, to our knowledge, this is the first reported case of a patient with appendiceal adenocarcinoma demonstrating clinical benefit and sustained stability of disease with combination chemotherapy plus bevacizumab.

  2. 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).

    Science.gov (United States)

    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. © The Author 2015. Published by Oxford University Press on behalf of the European Society for Medical Oncology. All rights reserved. For

  3. Opioid growth factor improves clinical benefit and survival in patients with advanced pancreatic cancer

    Directory of Open Access Journals (Sweden)

    Jill P Smith

    2010-03-01

    Full Text Available Jill P Smith1, Sandra I Bingaman1, David T Mauger2, Harold H Harvey1, Laurence M Demers3, Ian S Zagon41Departments of Medicine, 2Public Health Sciences, 3Pathology, and 4Neurosciences and Anatomy, Pennsylvania State University, College of Medicine, Hershey Medical Center, Hershey, PA, USABackground: Advanced pancreatic cancer carries the poorest prognosis of all gastrointestinal malignancies. Once the tumor has spread beyond the margins of the pancreas, chemotherapy is the major treatment modality offered to patients; however, chemotherapy does not significantly improve survival.Objective: Opioid growth factor (OGF; [Met5]-enkephalin is a natural peptide that has been shown to inhibit growth of pancreatic cancer in cell culture and in nude mice. The purpose of this study was to evaluate the effects of OGF biotherapy on subjects with advanced pancreatic cancer who failed chemotherapy.Methods: In a prospective phase II open-labeled clinical trial, 24 subjects who failed standard chemotherapy for advanced pancreatic cancer were treated weekly with OGF 250 μg/kg intravenously. Outcomes measured included clinical benefit, tumor response by radiographic imaging, quality of life, and survival.Results: Clinical benefit response was experienced by 53% of OGF-treated patients compared to historical controls of 23.8% and 4.8% for gemcitabine and 5-fluorouracil (5-FU, respectively. Of the subjects surviving more than eight weeks, 62% showed either a decrease or stabilization in tumor size by computed tomography. The median survival time for OGF-treated patients was three times that of untreated patients (65.5 versus 21 days, p < 0.001. No adverse effects on hematologic or chemistry parameters were noted, and quality of life surveys suggested improvement with OGF. Limitations: Measurements other than survival were not allowed in control patients, and clinical benefit comparisons were made to historical controls.Conclusion: OGF biotherapy improves the

  4. Perceived benefits of the use of learning contracts to guide clinical education in respiratory care students.

    Science.gov (United States)

    Rye, Kathy Jones-Boggs

    2008-11-01

    The benefits of contract learning have been identified in the literature as increased individualization to meet the student's individual needs, promotion of learner independence, and development of lifelong learning behaviors among students. I used an "action research" approach to implement the contract-learning method into a clinical course. Clinical learning contracts were designed to provide students with the opportunity to focus on any identified areas of unsatisfactory or desired practice. The learning contract specified how the learner would acquire the knowledge and attitudes relevant to their selected learning experience. The learning contract was used as a learning tool and as evidence of the student's development in the clinical experience. Twenty-four senior respiratory therapy students in the College of Health Related Professions, University of Arkansas for Medical Sciences, prepared and used learning contracts during their Clinical Practicum IV. After they had completed the clinical practicum and received their grades, I surveyed the students about their experience with the learning-contract method. The surveys were administered anonymously. Twenty-one students (88%) returned the surveys. The respondents were overall quite optimistic regarding learning contracts. They generally agreed that they could use the learning contract with confidence and that there is an increase in student autonomy and motivation in scholarship with a learning contract. The median agree/disagree ratings on the survey ranged from 1 (strongly agree) to 2 (agree). Contract learning is favorable to students' knowledge and skill acquisition and can be incorporated into clinical education of respiratory care students.

  5. Clinical Benefits of Joint Mobilization on Ankle Sprains: A Systematic Review and Meta-Analysis.

    Science.gov (United States)

    Weerasekara, Ishanka; Osmotherly, Peter; Snodgrass, Suzanne; Marquez, Jodie; de Zoete, Rutger; Rivett, Darren A

    2017-09-04

    To assess the clinical benefits of joint mobilization for ankle sprains. MEDLINE, MEDLINE In-Process, Embase, AMED, PsycINFO, CINAHL, Cochrane Library, PEDro, Scopus, SPORTDiscus, and Dissertations and Theses were searched from inception to June 2017. Studies investigating humans with grade I or II lateral or medial sprains of the ankle in any pathologic state from acute to chronic, who had been treated with joint mobilization were considered for inclusion. Any conservative intervention was considered as a comparator. Commonly reported clinical outcomes were considered such as ankle range of movement, pain, and function. After screening of 1530 abstracts, 56 studies were selected for full-text screening, and 23 were eligible for inclusion. Eleven studies on chronic sprains reported sufficient data for meta-analysis. Data were extracted using the participants, interventions, comparison, outcomes, and study design approach. Clinically relevant outcomes (dorsiflexion range, proprioception, balance, function, pain threshold, pain intensity) were assessed at immediate, short-term, and long-term follow-up points. Methodological quality was assessed independently by 2 reviewers, and most studies were found to be of moderate quality, with no studies rated as poor. Meta-analysis revealed significant immediate benefits of joint mobilization compared with comparators on improving posteromedial dynamic balance (P=.0004), but not for improving dorsiflexion range (P=.16), static balance (P=.96), or pain intensity (P=.45). Joint mobilization was beneficial in the short-term for improving weight-bearing dorsiflexion range (P=.003) compared with a control. Joint mobilization appears to be beneficial for improving dynamic balance immediately after application, and dorsiflexion range in the short-term. Long-term benefits have not been adequately investigated. Copyright © 2017 American Congress of Rehabilitation Medicine. Published by Elsevier Inc. All rights reserved.

  6. Net Clinical Benefit of Antithrombotic Therapy in Patients With Atrial Fibrillation and Chronic Kidney Disease

    DEFF Research Database (Denmark)

    Bonde, Anders Nissen; Lip, Gregory Y H; Kamper, Anne-Lise

    2014-01-01

    BACKGROUND: The balance between stroke reduction and increased bleeding associated with antithrombotic therapy among patients with atrial fibrillation (AF) and chronic kidney disease (CKD) is controversial. OBJECTIVES: This study assessed the risk associated with CKD in individual CHA₂DS₂-VASc...... (Congestive heart failure; Hypertension; Age ≥75 years; Diabetes mellitus; previous Stroke, transient ischemic attack, or thromboembolism; Vascular disease; Age 65 to 74 years; Sex category) strata and the net clinical benefit of warfarin in patients with AF and CKD in a nationwide cohort. METHODS...

  7. Exploring the teaching and learning of clinical reasoning, risks, and benefits of cervical spine manipulation.

    Science.gov (United States)

    Yamamoto, Katie; Condotta, Luca; Haldane, Chloe; Jaffrani, Sahar; Johnstone, Victoria; Jachyra, Patrick; Gibson, Barbara E; Yeung, Euson

    2017-10-20

    The aim of this study was to examine how risks and benefits of cervical spine manipulation (CSM) were framed and discussed in the context of mentorship and their impact on the perception of safe practice of CSM in clinical physiotherapy settings. A multi-method qualitative approach was employed, including a document analysis of established educational guidelines, observations of mentoring sessions, and individual face-to-face interviews with five mentees in the process of learning CSM, and four mentors with Orthopedic Manual Physical Therapy (OMPT) certification. Results demonstrated that participants' clinical decision-making processes to perform CSM were primarily oriented to the mitigation of risk. Achieving proficiency in the "science" of clinical reasoning and the "art" of "feel" related to mastering technical skills were viewed as means to mitigating risk and enhancing confidence to use CSM safely in clinical practice. While the "art" of technical skill mastery was of high importance to mentees and considered important to developing competency in performing CSM, it was discussed as distinct from their clinical reasoning processes. Thus, promoting a more balanced and integrated use of the "art" and "science" of safe practice for CSM in OMPT training may result in greater confidence and judicious use of CSM by physiotherapists.

  8. Perceived Benefits of Pre-Clinical Simulation-based Training on Clinical Learning Outcomes among Omani Undergraduate Nursing Students

    Directory of Open Access Journals (Sweden)

    Girija Madhavanprabhakaran

    2015-01-01

    Full Text Available Objectives: This study aimed to explore the benefits perceived by Omani undergraduate maternity nursing students regarding the effect of pre-clinical simulation-based training (PSBT on clinical learning outcomes. Methods: This non-experimental quantitative survey was conducted between August and December 2012 among third-year baccalaureate nursing students at Sultan Qaboos University in Muscat, Oman. Voluntary participants were exposed to faculty-guided PSBT sessions using low- and medium-fidelity manikins, standardised scenarios and skill checklists on antenatal, intranatal, postnatal and newborn care and assessment. Participants answered a purposely designed self-administered questionnaire on the benefits of PSBT in enhancing learning outcomes. Items were categorised into six subscales: knowledge, skills, patient safety, academic safety, confidence and satisfaction. Scores were rated on a four-point Likert scale. Results: Of the 57 participants, the majority (95.2% agreed that PSBT enhanced their knowledge. Most students (94.3% felt that their patient safety practices improved and 86.5% rated PSBT as beneficial for enhancing skill competencies. All male students and 97% of the female students agreed that PSBT enhanced their confidence in the safe holding of newborns. Moreover, 93% of participants were satisfied with PSBT. Conclusion: Omani undergraduate nursing students perceived that PSBT enhanced their knowledge, skills, patient safety practices and confidence levels in providing maternity care. These findings support the use of simulation training as a strategy to facilitate clinical learning outcomes in future nursing courses in Oman, although further research is needed to explore the objective impact of PSBT on learning outcomes.

  9. Perceived Benefits of Pre-Clinical Simulation-based Training on Clinical Learning Outcomes among Omani Undergraduate Nursing Students.

    Science.gov (United States)

    Madhavanprabhakaran, Girija; Al-Khasawneh, Esra; Wittmann, Lani

    2015-02-01

    This study aimed to explore the benefits perceived by Omani undergraduate maternity nursing students regarding the effect of pre-clinical simulation-based training (PSBT) on clinical learning outcomes. This non-experimental quantitative survey was conducted between August and December 2012 among third-year baccalaureate nursing students at Sultan Qaboos University in Muscat, Oman. Voluntary participants were exposed to faculty-guided PSBT sessions using low- and medium-fidelity manikins, standardised scenarios and skill checklists on antenatal, intranatal, postnatal and newborn care and assessment. Participants answered a purposely designed self-administered questionnaire on the benefits of PSBT in enhancing learning outcomes. Items were categorised into six subscales: knowledge, skills, patient safety, academic safety, confidence and satisfaction. Scores were rated on a four-point Likert scale. Of the 57 participants, the majority (95.2%) agreed that PSBT enhanced their knowledge. Most students (94.3%) felt that their patient safety practices improved and 86.5% rated PSBT as beneficial for enhancing skill competencies. All male students and 97% of the female students agreed that PSBT enhanced their confidence in the safe holding of newborns. Moreover, 93% of participants were satisfied with PSBT. Omani undergraduate nursing students perceived that PSBT enhanced their knowledge, skills, patient safety practices and confidence levels in providing maternity care. These findings support the use of simulation training as a strategy to facilitate clinical learning outcomes in future nursing courses in Oman, although further research is needed to explore the objective impact of PSBT on learning outcomes.

  10. Telepharmacy: a pharmacist’s perspective on the clinical benefits and challenges

    Directory of Open Access Journals (Sweden)

    Poudel A

    2016-10-01

    Full Text Available Arjun Poudel, Lisa M Nissen School of Clinical Sciences, Faculty of Health, Queensland University of Technology, Brisbane, QLD, Australia Abstract: The use of information and telecommunication technologies has expanded at a rapid rate, which has a strong influence on healthcare delivery in many countries. Rural residents and communities, however, often lack easy access to healthcare services due to geographical and demographical factors. Telepharmacy, a more recent concept that refers to pharmaceutical service provision, enables healthcare services, such as medication review, patients counseling, and prescription verification, by a qualified pharmacist for the patients located at a distance from a remotely located hospital, pharmacy, or healthcare center. Telepharmacy has many recognizable benefits such as the easy access to healthcare services in remote and rural locations, economic benefits, patient satisfaction as a result of medication access and information in rural areas, effective patient counseling, and minimal scarcity of local pharmacist and pharmacy services. Telepharmacy undoubtedly is a great concept, but it is sometimes challenging to put into practice. Inherent to the adoption of these practices are legal challenges and pitfalls that need to be addressed. The start-up of telepharmacy (hardware, software, connectivity, and operational cost involves considerable time, effort, and money. For rural hospitals with fewer patients, the issue of costs appears to be one of the biggest barriers to telepharmacy services. Moreover, execution and implementation of comprehensive and uniform telepharmacy law is still a challenge. A well-developed system, however, can change the practice of pharmacy that is beneficial to both the rural communities and the hospitals or retail pharmacies that deliver these services. Keywords: challenges, clinical benefits, healthcare services, pharmacist, telepharmacy

  11. Cognitive-behavioral therapy for schizophrenia: a critical evaluation of its theoretical framework from a clinical-phenomenological perspective.

    Science.gov (United States)

    Skodlar, B; Henriksen, M G; Sass, L A; Nelson, B; Parnas, J

    2013-01-01

    Cognitive-behavioral therapy (CBT) has played an increasingly important role in psychotherapy for schizophrenia since the 1990s, but it has also encountered many theoretical and practical limitations. For example, methodologically rigorous meta-analyses have recently found only modest overall effect sizes of CBT treatment, and therefore questions have emerged about forwhat and for whom it actually works. The focus of the present paper is to elucidate the theoretical assumptions underlying CBT for schizophrenia and to examine their consistency with abnormalities of experience and self-awareness frequently reported by schizophrenia patients and systematically studied in phenomenological psychopathology from the beginning of the 20th century. We argue that a strong theoretical emphasis on cognitive appraisals with only subsidiary attention devoted to affective and behavioral processes - as is characteristic of many forms of CBT - cannot satisfactorily account for the complex subjective experiences of schizophrenia patients. We further argue that certain theoretical strategies widely employed in CBT to explore and explain mental disorders, which involve atomization and, at times, a reification of mental phenomena, can be problematic and may result in a loss of explanatory potential. Finally, we provide a detailed account of how negative symptoms and delusions are conceptualized in CBT and consider the question of how these concepts fit the actual phenomenology of schizophrenia. We suggest that further advancement of CBT theory and practice can benefit from a dialogue with phenomenological psychiatry in the search for effective psychotherapeutic strategies for schizophrenia patients. Copyright © 2012 S. Karger AG, Basel.

  12. Chyawanprash: A review of therapeutic benefits as in authoritative texts and documented clinical literature.

    Science.gov (United States)

    Narayana, D B Anantha; Durg, Sharanbasappa; Manohar, P Ram; Mahapatra, Anita; Aramya, A R

    2017-02-02

    Chyawanprash (CP), a traditional immune booster recipe, has a long history of ethnic origin, development, household preparation and usage. There are even mythological stories about the origin of this recipe including its nomenclature. In the last six decades, CP, because of entrepreneurial actions of some research Vaidyas (traditional doctors) has grown to industrial production and marketing in packed forms to a large number of consumers/patients like any food or health care product. Currently, CP has acquired a large accepted user base in India and in a few countries out-side India. Authoritative texts, recognized by the Drugs and Cosmetics Act of India, describe CP as an immunity enhancer and strength giver meant for improving lung functions in diseases with compromised immunity. This review focuses on published clinical efficacy and safety studies of CP for correlation with health benefits as documented in the authoritative texts, and also briefs on its recipes and processes. Authoritative texts were searched for recipes, processes, and other technical details of CP. Labels of marketing CP products (Indian) were studied for the health claims. Electronic search for studies of CP on efficacy and safety data were performed in PubMed/MEDLINE and DHARA (Digital Helpline for Ayurveda Research Articles), and Ayurvedic books were also searched for clinical studies. The documented clinical studies from electronic databases and Ayurvedic books evidenced that individuals who consume CP regularly for a definite period of time showed improvement in overall health status and immunity. However, most of the clinical studies in this review are of smaller sample size and short duration. Further, limitation to access and review significant data on traditional products like CP in electronic databases was noted. Randomized controlled trials of high quality with larger sample size and longer follow-up are needed to have significant evidence on the clinical use of CP as immunity

  13. Review of nanomaterials in dentistry: interactions with the oral microenvironment, clinical applications, hazards, and benefits.

    Science.gov (United States)

    Besinis, Alexandros; De Peralta, Tracy; Tredwin, Christopher J; Handy, Richard D

    2015-03-24

    Interest in the use of engineered nanomaterials (ENMs) as either nanomedicines or dental materials/devices in clinical dentistry is growing. This review aims to detail the ultrafine structure, chemical composition, and reactivity of dental tissues in the context of interactions with ENMs, including the saliva, pellicle layer, and oral biofilm; then describes the applications of ENMs in dentistry in context with beneficial clinical outcomes versus potential risks. The flow rate and quality of saliva are likely to influence the behavior of ENMs in the oral cavity, but how the protein corona formed on the ENMs will alter bioavailability, or interact with the structure and proteins of the pellicle layer, as well as microbes in the biofilm, remains unclear. The tooth enamel is a dense crystalline structure that is likely to act as a barrier to ENM penetration, but underlying dentinal tubules are not. Consequently, ENMs may be used to strengthen dentine or regenerate pulp tissue. ENMs have dental applications as antibacterials for infection control, as nanofillers to improve the mechanical and bioactive properties of restoration materials, and as novel coatings on dental implants. Dentifrices and some related personal care products are already available for oral health applications. Overall, the clinical benefits generally outweigh the hazards of using ENMs in the oral cavity, and the latter should not prevent the responsible innovation of nanotechnology in dentistry. However, the clinical safety regulations for dental materials have not been specifically updated for ENMs, and some guidance on occupational health for practitioners is also needed. Knowledge gaps for future research include the formation of protein corona in the oral cavity, ENM diffusion through clinically relevant biofilms, and mechanistic investigations on how ENMs strengthen the tooth structure.

  14. Mobile Learning in a Rural Medical School: Feasibility and Educational Benefits in Campus and Clinical Settings

    Directory of Open Access Journals (Sweden)

    Debra Nestel

    2014-01-01

    Full Text Available Students in a new medical school were provided with laptops. This study explored the feasibility and educational benefits of mobile learning for two cohorts of students learning in two settings—university campus (first-year students and rural clinical placements (second-year students. Evaluation involved questionnaires, focus groups (faculty and students, and document analysis. Descriptive statistics were computed. Focus groups were audio-recorded, transcribed, and analysed thematically. Response rates for questionnaires exceeded 84%. Compared with second-year students, significantly more first-year students (60% took their laptops to campus daily (P=0.14 and used their laptops for more hours each day (P=0.031. All students used laptops most frequently to access the internet (85% and 97% and applications (Microsoft Word (80% and 61% and Microsoft PowerPoint (80% and 63%. Focus groups with students revealed appreciation for the laptops but frustration with the initial software image. Focus groups with faculty identified enthusiasm for mobile learning but acknowledged its limitations. Physical infrastructure and information technology support influenced mobile learning. Document analysis revealed significant costs and issues with maintenance. If adequately resourced, mobile learning through university-issued laptops would be feasible and have educational benefits, including equitable access to learning resources, when and where they are needed. However, barriers remain for full implementation.

  15. Advance MRI for pediatric brain tumors with emphasis on clinical benefits

    Energy Technology Data Exchange (ETDEWEB)

    Goo, Hyun Woo; Ra, Young Shin [Asan Medical Center, University of Ulsan College of Medicine, Seoul(Korea, Republic of)

    2017-01-15

    Conventional anatomic brain MRI is often limited in evaluating pediatric brain tumors, the most common solid tumors and a leading cause of death in children. Advanced brain MRI techniques have great potential to improve diagnostic performance in children with brain tumors and overcome diagnostic pitfalls resulting from diverse tumor pathologies as well as nonspecific or overlapped imaging findings. Advanced MRI techniques used for evaluating pediatric brain tumors include diffusion-weighted imaging, diffusion tensor imaging, functional MRI, perfusion imaging, spectroscopy, susceptibility-weighted imaging, and chemical exchange saturation transfer imaging. Because pediatric brain tumors differ from adult counterparts in various aspects, MRI protocols should be designed to achieve maximal clinical benefits in pediatric brain tumors. In this study, we review advanced MRI techniques and interpretation algorithms for pediatric brain tumors.

  16. RELATIONAL NEEDS OF THE THERAPIST: COUNTERTRANSFERENCE, CLINICAL WORK AND SUPERVISION. BENEFITS AND DISRUPTIONS IN PSYCHOTHERAPY

    Directory of Open Access Journals (Sweden)

    Lindsay Stewart

    2010-02-01

    Full Text Available Relational needs are the emotional needs which underlie our social connectedness and help sustain and nurture our attachments to others. In doing psychotherapy, therapists must be attuned not only to the needs of the client, but also to their own relational needs. Through self awareness and knowledge of healthy and appropriate boundaries, therapists can ensure the best interest of the client is kept foremost. In this article, the influence of the therapist’s own relational needs in the psychotherapy process is examined in terms of the possible benefits and disruptions to the client’s emotional growth. This is discussed in the context of the Integrative Psychotherapy model based on the core concepts of inquiry, involvement and attunement. Clinical supervision is seen as an important part of working through counter-transference.

  17. Subjective measures of hearing aid benefit in the NIDCD/VA Clinical Trial.

    Science.gov (United States)

    Haskell, George B; Noffsinger, Douglas; Larson, Vernon D; Williams, David W; Dobie, Robert A; Rogers, Janette L

    2002-08-01

    Subjective measures of performance were assessed on three different hearing aid circuits as part of a large clinical trial. These measurements included the Profile of Hearing Aid Performance and a subjective ranking of individual preference. A multi-center, double-masked clinical trial of hearing aids was conducted at eight VA Medical Centers. Three hearing aid circuits, a linear peak-clipper, a linear compression limiter and a wide dynamic range compressor, were investigated. The experimental design was a three-period, three-treatment crossover design. Subjects (N = 360) were stratified by site and randomized to one of six sequences for the hearing aid circuits. All fittings were binaural and involved a 3-mo trial with each of the three circuits. All subjective measures were administered for unaided and aided conditions at the end of each trial period. While all of the circuits resulted in improved scores on the aided versus the unaided PHAP, there were few conditions in which one circuit outperformed the others. An exception was the aversiveness of sound subscale where the peak clipper frequently scored worse than either the compression limiter or the wide dynamic range compressor. In the subjective ranking scale the compression limiter received more first place rankings than the other two circuits, especially for one subgroup of patients with moderate flat hearing loss. All circuits were perceived as beneficial by these subjects in most situations. The peak clipper scored worse on aversiveness of sound than did the other two circuits for most subjects, while the compression limiter seemed to have a slight advantage in subjective rankings. Most subjects perceived considerable aided benefit in situations involving background noise and reverberation, situations where hearing aid benefit is often questioned.

  18. Sustained clinical and structural benefit after joint distraction in the treatment of severe knee osteoarthritis.

    Science.gov (United States)

    Wiegant, K; van Roermund, P M; Intema, F; Cotofana, S; Eckstein, F; Mastbergen, S C; Lafeber, F P J G

    2013-11-01

    Treatment of severe osteoarthritis (OA) in relatively young patients is challenging. Although successful, total knee prosthesis has a limited lifespan, with the risk of revision surgery, especially in active young patients. Knee joint distraction (KJD) provides clinical benefit and tissue structure modification at 1-year follow-up. The present study evaluates whether this benefit is preserved during the second year of follow-up. Patients included in this study presented with end-stage knee OA and an indication for total knee replacement (TKR); they were less than 60 years old with a VAS pain ≥60 mm (n = 20). KJD was applied for 2 months (range 54-64 days) and clinical parameters assessed using the WOMAC questionnaire and VAS pain score. Changes in cartilage structure were measured using quantitative MRI, radiography, and biochemical analyses of collagen type II turnover (ELISA). Average follow-up was 24 (range 23-25) months. Clinical improvement compared with baseline (BL) was observed at 2-year follow-up: WOMAC improved by 74% (P MRI (2.35 mm (95%CI, 2.06-2.65) at BL) was significantly greater at 2-year follow-up (2.78 mm (2.50-3.09); P = 0.03). Radiographic minimum joint space width (JSW) (1.1 mm (0.5-1.7) at BL) was significantly increased at 2-year follow-up as well (1.7 mm (1.1-2.3); P = 0.03). The denuded area of subchondral bone visualized by MRI (22% (95%CI, 12.5-31.5) at BL) was significantly decreased at 2-year follow-up (8% (3.6-12.2); P = 0.004). The ratio of collagen type II synthesis over breakdown was increased at 2-year follow-up (P = 0.07). Clinical improvement by KJD treatment is sustained for at least 2 years. Cartilage repair is still present after 2 years (MRI) and the newly formed tissue continues to be mechanically resilient as shown by an increased JSW under weight-bearing conditions. Copyright © 2013 Osteoarthritis Research Society International. Published by Elsevier Ltd. All rights reserved.

  19. Defining substantial clinical benefit for patient-rated outcome tools for shoulder impingement syndrome.

    Science.gov (United States)

    Michener, Lori A; Snyder Valier, Alison R; McClure, Philip W

    2013-04-01

    To define for 2 shoulder outcomes scales the substantial clinical benefit (SCB)-a metric that defines the change amount associated with patient perception of a large meaningful improvement and that can be used to interpret change over time in the outcome score. Cohort. Clinic. Patients (N=74) with shoulder impingement syndrome. Standardized exercise and manual therapy for 6 weeks, and outcome measures completed at initial evaluation, discharge, and 6 to 8 weeks postdischarge. Disabilities of the Arm, Shoulder and Hand (DASH), Pennsylvania Shoulder Score (Penn), and a 13-point Global Rating of Change (GROC). Patients were classified as "substantially improved" when they reported "quite a bit better" (11) or greater on the GROC at discharge and again 6 to 8 weeks after discharge. Patients with GROC <11 at discharge or follow-up were classified as "nonsubstantially improved." The percentage and raw points change in the Penn and DASH that corresponded with patient-rated substantial improvement was determined with receiver operator characteristic (ROC) analyses. ROC analyses revealed the SCB for the DASH was 40% (area under the curve [AUC]=.79; confidence interval [CI], .69-.89) and 11 points (AUC=.63; CI, .50-.76); and for the Penn, 20% (AUC=.76; CI, .65-.87) and 21 points (AUC=.80; CI, .69-.90). The SCB of 40% for the DASH, and 20% and 21 points for the Penn represents substantial improvement over 6 weeks of care, which was sustained at 12 weeks. The SCB of 11 points for the DASH is not recommended for use because of poor discrimination. The SCB can be used to enable clinical decision-making and in future clinical trials. Alternative approaches such as the within- and between-group change values can produce different SCB values. Copyright © 2013 American Congress of Rehabilitation Medicine. Published by Elsevier Inc. All rights reserved.

  20. Low molecular weight heparin biosimilars: how much similarity for how much clinical benefit?

    Science.gov (United States)

    Drouet, Ludovic

    2012-03-01

    The development of biosimilar versions of low molecular weight heparins (LMWHs) raises real medical concerns. To illustrate this, we have chosen as an example the specific clinical setting of antithrombotic management of acute coronary syndromes (ACS). In this indication, the LMWH enoxaparin has consistently shown its superiority in terms of efficacy when compared to unfractionated heparin (UFH) and in a number of direct or indirect comparisons to other LMWHs. For this reason, enoxaparin has become the gold standard for anticoagulation in cardiology, recommended by practice guidelines and extensively used in everyday practice. We are concerned by the fact that some patients might be treated with a biosimilar copy of enoxaparin, on the basis of simplified criteria that are not specific enough to differentiate between different available LMWHs and are thus unable to differentiate between enoxaparin and a biosimilar. In the absence of evidence from clinical trials, especially in ACS, we believe that it is difficult to ensure that the benefit/risk ratio of enoxaparin and its copy are equivalent. In addition to efficacy, safety issues also have to be taken into consideration, since biosimilars consist of glycan chain mixtures that exhibit specific immunoallergic features. Contamination of raw material with other glycans or xenobiotic material during extraction and fractionation may trigger potentially harmful immune reactions.

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

    Science.gov (United States)

    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. © 2013 John Wiley & Sons A/S. Published by John Wiley & Sons Ltd.

  2. FOXM1 coming of age: Time for translation into clinical benefits?

    Directory of Open Access Journals (Sweden)

    Muy-Teck eTeh

    2012-10-01

    Full Text Available A decade since the first evidence implicating the cell cycle transcription factor FOXM1 in human tumourigenesis, a slew of subsequent studies revealed an oncogenic role of FOXM1 in the majority of human cancers including oral, nasopharynx, oropharynx, oesophagus, breast, ovary, prostate, lung, liver, pancreas, kidney, colon, brain, cervix, thyroid, bladder, uterus, testis, stomach, skin and blood. Its aberrant upregulation in almost all different cancer types suggests a fundamental role for FOXM1 in tumourigenesis. Its dose-dependent expression pattern correlated well with tumour progression starting from cancer predisposition and initiation, early premalignancy and progression, to metastatic invasion. In addition, emerging studies have demonstrated a causal link between FOXM1 and chemotherapeutic drug resistance. Despite the well-established multifaceted roles for FOXM1 in all stages of oncogenesis, its translation into clinical benefit is yet to materialise. In this contribution, I reviewed and discussed how our current knowledge on the oncogenic mechanisms of FOXM1 could be exploited for clinical use as biomarker for risk prediction, early cancer screening, molecular diagnostics/prognostics and/or companion diagnostics for pers

  3. Escitalopram—translating molecular properties into clinical benefit: reviewing the evidence in major depression

    Science.gov (United States)

    Leonard, Brian; Taylor, David

    2010-01-01

    The majority of currently marketed drugs contain a mixture of enantiomers; however, recent evidence suggests that individual enantiomers can have pharmacological properties that differ importantly from enantiomer mixtures. Escitalopram, the S-enantiomer of citalopram, displays markedly different pharmacological activity to the R-enantiomer. This review aims to evaluate whether these differences confer any significant clinical advantage for escitalopram over either citalopram or other frequently used antidepressants. Searches were conducted using PubMed and EMBASE (up to January 2009). Abstracts of the retrieved studies were reviewed independently by both authors for inclusion. Only those studies relating to depression or major depressive disorder were included. The search identified over 250 citations, of which 21 studies and 18 pooled or meta-analyses studies were deemed suitable for inclusion. These studies reveal that escitalopram has some efficacy advantage over citalopram and paroxetine, but no consistent advantage over other selective serotonin reuptake inhibitors. Escitalopram has at least comparable efficacy to available serotonin-norepinephrine reuptake inhibitors, venlafaxine XR and duloxetine, and may offer some tolerability advantages over these agents. This review suggests that the mechanistic advantages of escitalopram over citalopram translate into clinical efficacy advantages. Escitalopram may have a favourable benefit-risk ratio compared with citalopram and possibly with several other antidepressant agents. PMID:20147575

  4. Escitalopram--translating molecular properties into clinical benefit: reviewing the evidence in major depression.

    LENUS (Irish Health Repository)

    Leonard, Brian

    2010-08-01

    The majority of currently marketed drugs contain a mixture of enantiomers; however, recent evidence suggests that individual enantiomers can have pharmacological properties that differ importantly from enantiomer mixtures. Escitalopram, the S-enantiomer of citalopram, displays markedly different pharmacological activity to the R-enantiomer. This review aims to evaluate whether these differences confer any significant clinical advantage for escitalopram over either citalopram or other frequently used antidepressants. Searches were conducted using PubMed and EMBASE (up to January 2009). Abstracts of the retrieved studies were reviewed independently by both authors for inclusion. Only those studies relating to depression or major depressive disorder were included. The search identified over 250 citations, of which 21 studies and 18 pooled or meta-analyses studies were deemed suitable for inclusion. These studies reveal that escitalopram has some efficacy advantage over citalopram and paroxetine, but no consistent advantage over other selective serotonin reuptake inhibitors. Escitalopram has at least comparable efficacy to available serotonin-norepinephrine reuptake inhibitors, venlafaxine XR and duloxetine, and may offer some tolerability advantages over these agents. This review suggests that the mechanistic advantages of escitalopram over citalopram translate into clinical efficacy advantages. Escitalopram may have a favourable benefit-risk ratio compared with citalopram and possibly with several other antidepressant agents.

  5. Genetic Risk, Coronary Heart Disease Events, and the Clinical Benefit of Statin Therapy

    Science.gov (United States)

    Smith, JG; Chasman, DI; Caulfield, M; Devlin, JJ; Nordio, F; Hyde, C; Cannon, CP; Sacks, F; Poulter, N; Sever, P; Ridker, PM; Braunwald, E; Melander, O

    2015-01-01

    Background Genetic variants have been associated with the risk of coronary heart disease (CHD). We tested whether a composite of these variants could identify the risk of both incident as well as recurrent CHD events and distinguish individuals who derived greater clinical benefit from statin therapy. Methods A community-based cohort and four randomized controlled trials of both primary (JUPITER and ASCOT) and secondary (CARE and PROVE IT-TIMI 22) prevention with statin therapy totaling 48,421 individuals and 3,477 events were included in these analyses. We examined the association of a genetic risk score based on 27 genetic variants with incident or recurrent CHD, adjusting for established clinical predictors. We then investigated the relative and absolute risk reductions in CHD events with statin therapy stratified by genetic risk. Data from studies were combined using meta-analysis. Findings When individuals were divided into low (quintile 1), intermediate (quintiles 2-4), and high (quintile 5) genetic risk categories, a significant gradient of risk for incident or recurrent CHD was demonstrated with the multivariable-adjusted HRs (95% CI) for CHD for the intermediate and high genetic risk categories vs. low genetic risk category being 1.32 (1.20-1.46, Prisk reduction across the low, intermediate, and high genetic risk categories (13%, 29%, and 48%, P=0.0277). Similarly, greater absolute risk reductions were seen in those individuals in higher genetic risk categories (P=0.0101), resulting in an approximate three-fold gradient in the number needed to treat (NNT) in the primary prevention trials. Specifically, in the primary prevention trials, the NNT to prevent one MACE over 10 years for the low, intermediate, and high GRS individuals was 66, 42, and 25 in JUPITER and 57, 47, and 20 in ASCOT. Interpretation A genetic risk score identified individuals at increased risk for both incident and recurrent CHD events. Individuals with the highest burden of genetic risk

  6. Theoretical and practical considerations for teaching diagnostic electronic-nose technologies to clinical laboratory technicians

    Science.gov (United States)

    Alphus D. Wilson

    2012-01-01

    The rapid development of new electronic technologies and instruments, utilized to perform many current clinical operations in the biomedical field, is changing the way medical health care is delivered to patients. The majority of test results from laboratory analyses, performed with these analytical instruments often prior to clinical examinations, are frequently used...

  7. How do small groups make decisions? : A theoretical framework to inform the implementation and study of clinical competency committees.

    Science.gov (United States)

    Chahine, Saad; Cristancho, Sayra; Padgett, Jessica; Lingard, Lorelei

    2017-06-01

    In the competency-based medical education (CBME) approach, clinical competency committees are responsible for making decisions about trainees' competence. However, we currently lack a theoretical model for group decision-making to inform this emerging assessment phenomenon. This paper proposes an organizing framework to study and guide the decision-making processes of clinical competency committees.This is an explanatory, non-exhaustive review, tailored to identify relevant theoretical and evidence-based papers related to small group decision-making. The search was conducted using Google Scholar, Web of Science, MEDLINE, ERIC, and PsycINFO for relevant literature. Using a thematic analysis, two researchers (SC & JP) met four times between April-June 2016 to consolidate the literature included in this review.Three theoretical orientations towards group decision-making emerged from the review: schema, constructivist, and social influence. Schema orientations focus on how groups use algorithms for decision-making. Constructivist orientations focus on how groups construct their shared understanding. Social influence orientations focus on how individual members influence the group's perspective on a decision. Moderators of decision-making relevant to all orientations include: guidelines, stressors, authority, and leadership.Clinical competency committees are the mechanisms by which groups of clinicians will be in charge of interpreting multiple assessment data points and coming to a shared decision about trainee competence. The way in which these committees make decisions can have huge implications for trainee progression and, ultimately, patient care. Therefore, there is a pressing need to build the science of how such group decision-making works in practice. This synthesis suggests a preliminary organizing framework that can be used in the implementation and study of clinical competency committees.

  8. Assessment of positive functioning in clinical psychology: theoretical and practical issues.

    Science.gov (United States)

    Joseph, Stephen; Wood, Alex

    2010-11-01

    Positive psychology has led to an increasing emphasis on the promotion of positive functioning in clinical psychology research and practice, raising issues of how to assess the positive in clinical setting. Three key considerations are presented. First, existing clinical measures may already be assessing positive functioning, if positive and negative functioning exist on a single continuum (such as on bipolar dimensions from happiness to depression, and from anxiety to relaxation). Second, specific measures of positive functioning (e.g., eudemonic well-being) could be used in conjunction with existing clinical scales. Third, completely different measures would be needed depending on whether well-being is defined as emotional or medical functioning, or as humanistically orientated growth (e.g., authenticity). It is important that clinical psychologists introduce positive functioning into their research and practice in order to widen their armoury of therapeutic interventions, but in doing so researchers and practitioners need also to be aware that they are shifting the agenda of clinical psychology. As such, progress in clinical psychology moving toward the adoption of positive functioning requires reflection on epistemological foundations. Copyright © 2010 Elsevier Ltd. All rights reserved.

  9. Cerebrospinal fluid pulse pressure and craniospinal dynamics : a theoretical, clinical and experimental study

    NARCIS (Netherlands)

    C.J.J. Avezaat (Cees); J.H.M. van Eijndhoven (Johannes Hubertus Marcellianus)

    1984-01-01

    textabstractSince the introduction of continuous recording of intracranial pressure (ICP) in neurosurgical practice (Guillaume and Janny, 1951; Lundberg, 1960) this method has greatly contributed to clinical research in the field of intracranial hypertension. Numerous publications have enriched the

  10. Two approaches to incorporate clinical data uncertainty into multiple criteria decision analysis for benefit-risk assessment of medicinal products.

    Science.gov (United States)

    Wen, Shihua; Zhang, Lanju; Yang, Bo

    2014-07-01

    The Problem formulation, Objectives, Alternatives, Consequences, Trade-offs, Uncertainties, Risk attitude, and Linked decisions (PrOACT-URL) framework and multiple criteria decision analysis (MCDA) have been recommended by the European Medicines Agency for structured benefit-risk assessment of medicinal products undergoing regulatory review. The objective of this article was to provide solutions to incorporate the uncertainty from clinical data into the MCDA model when evaluating the overall benefit-risk profiles among different treatment options. Two statistical approaches, the δ-method approach and the Monte-Carlo approach, were proposed to construct the confidence interval of the overall benefit-risk score from the MCDA model as well as other probabilistic measures for comparing the benefit-risk profiles between treatment options. Both approaches can incorporate the correlation structure between clinical parameters (criteria) in the MCDA model and are straightforward to implement. The two proposed approaches were applied to a case study to evaluate the benefit-risk profile of an add-on therapy for rheumatoid arthritis (drug X) relative to placebo. It demonstrated a straightforward way to quantify the impact of the uncertainty from clinical data to the benefit-risk assessment and enabled statistical inference on evaluating the overall benefit-risk profiles among different treatment options. The δ-method approach provides a closed form to quantify the variability of the overall benefit-risk score in the MCDA model, whereas the Monte-Carlo approach is more computationally intensive but can yield its true sampling distribution for statistical inference. The obtained confidence intervals and other probabilistic measures from the two approaches enhance the benefit-risk decision making of medicinal products. Copyright © 2014 International Society for Pharmacoeconomics and Outcomes Research (ISPOR). Published by Elsevier Inc. All rights reserved.

  11. Clinical-diffusion mismatch and benefit from thrombolysis 3 to 6 hours after acute stroke.

    Science.gov (United States)

    Ebinger, Martin; Iwanaga, Takeshi; Prosser, Jane F; De Silva, Deidre A; Christensen, Soren; Collins, Marnie; Parsons, Mark W; Levi, Christopher R; Bladin, Christopher F; Barber, P Alan; Donnan, Geoffrey A; Davis, Stephen M

    2009-07-01

    The clinical-diffusion mismatch (CDM) model has been proposed as a simpler tool than perfusion-diffusion mismatch (PDM) to select acute ischemic stroke patients for thrombolytic therapy. We hypothesized that in the 3- to 6-hour time window, the effect of tPA was significantly greater in patients with CDM than in patients without CDM. This is a substudy of EPITHET, a double-blind multi-center study of 100 patients randomized to tPA or placebo 3 to 6 hours after stroke onset. MRI was obtained before treatment, and at 3 to 5 days and 90 days after treatment. Presence of PDM (perfusion deficit/DWI(volume) >1.2 and perfusion deficit at least 10 mL>DWI(volume)) and CDM (NIHSS >or=8 and DWI(volume) or=8 points between baseline and 90 days, or a 90-day NIHSS clinical course in CDM patients compared to patients without CDM. There was no increased benefit from tPA in patients with CDM. The beneficial effects of reperfusion were similar in patients with and without CDM.

  12. Clinical benefits of pharmacogenetic algorithm-based warfarin dosing: meta-analysis of randomized controlled trials.

    Science.gov (United States)

    Li, Xiaoqi; Yang, Jie; Wang, Xuyun; Xu, Qiang; Zhang, Yuxiao; Yin, Tong

    2015-04-01

    Pharmacogenetic (PG) algorithms were proposed to predict warfarin therapeutic dose more accurately. However, the clinical efficacy of the strategy over the standard treatment was not consistently proven. We conducted a meta-analysis of the published randomized controlled trials (RCTs) comparing PG algorithm-based warfarin dosing (PG group) with clinical or standard protocols (STD group). The PUBMED, EMBASE, Cochrane Library and Web of Science databases were searched up to June 2014. A total of 10 RCTs were retrieved for the meta-analysis with the inclusion of 2,601 participants. Primary analysis showed both major bleeding (2.65% versus 4.75%; RR: 0.57, 95% CI: 0.37- 0.90, P=0.02) and thromboembolic events (0.59% versus 1.88%; RR: 0.38, 95% CI: 0.17-0.85, P=0.02) were significantly lower in PG than in STD group. There was a trend towards increased percentage of time in therapeutic range (%TTR) [mean difference (MD): 4.65, 95% CI: 0.01- 9.29, P=0.05] in PG group, but no difference was observed for over-anticoagulation (INR>4). Subgroup analyses showed significant reduction of both major bleeding and thromboembolic events in PG group when the follow-up time was more than 1 month. After stratified by different PG algorithms, significant major bleeding reduction could be found in PG group when warfarin indication or co-medication of amiodarone was integrated in the algorithms. PG algorithm-guided warfarin anticoagulation is beneficial for the reduction of both major bleeding and thromboembolic events compared with standard dosing strategy. The benefits may be prominent in patients with longer follow-up time, or guided by refined PG algorithms. Copyright © 2015 Elsevier Ltd. All rights reserved.

  13. Cost-benefit analysis of childhood asthma management through school-based clinic programs.

    Science.gov (United States)

    Tai, Teresa; Bame, Sherry I

    2011-04-01

    Asthma is a leading chronic illness among American children. School-based health clinics (SBHCs) reduced expensive ER visits and hospitalizations through better healthcare access and monitoring in select case studies. The purpose of this study was to examine the cost-benefit of SBHC programs in managing childhood asthma nationwide for reduction in medical costs of ER, hospital and outpatient physician care and savings in opportunity social costs of lowing absenteeism and work loss and of future earnings due to premature deaths. Eight public data sources were used to compare costs of delivering primary and preventive care for childhood asthma in the US via SBHC programs, including direct medical and indirect opportunity costs for children and their parents. The costs of nurse staffing for a nationwide SBHC program were estimated at $4.55 billion compared to the estimated medical savings of $1.69 billion, including ER, hospital, and outpatient care. In contrast, estimated total savings for opportunity costs of work loss and premature death were $23.13 billion. Medical savings alone would not offset the expense of implementing a SBHC program for prevention and monitoring childhood asthma. However, even modest estimates of reducing opportunity costs of parents' work loss would be far greater than the expense of this program. Although SBHC programs would not be expected to affect the increasing prevalence of childhood asthma, these programs would be designed to reduce the severity of asthma condition with ongoing monitoring, disease prevention and patient compliance.

  14. Clinical benefit of tolvaptan in patients with acute decompensated heart failure and chronic kidney disease.

    Science.gov (United States)

    Uemura, Yusuke; Shibata, Rei; Takemoto, Kenji; Uchikawa, Tomohiro; Koyasu, Masayoshi; Ishikawa, Shinji; Mitsuda, Takayuki; Miura, Ayako; Imai, Ryo; Iwamiya, Satoshi; Ozaki, Yuta; Kato, Tomohiro; Miura, Takanori; Watarai, Masato; Murohara, Toyoaki

    2016-10-01

    Tolvaptan, a vasopressin type 2 receptor antagonist, has an aquaretic effect without affecting renal function. The effects of long-term tolvaptan administration in heart failure patients with renal dysfunction have not been clarified. Here, we assessed the clinical benefit of tolvaptan during a 6-month follow-up in acute decompensated heart failure (ADHF) patients with severe chronic kidney disease (CKD; estimated glomerular filtration rate (eGFR) tolvaptan in addition to loop diuretics (TLV group), with 36 patients with ADHF and severe CKD who were administered high-dose loop diuretics (≥40 mg) alone (LD group). Alterations in serum creatinine and eGFR levels from the time of hospital discharge to 6-month follow-up were significantly different between the groups, with those in the TLV group being more favorable. Furthermore, Kaplan-Meier analysis revealed that rehospitalization for heart failure (HF) was significantly lower in the TLV group compared with the LD group. In ADHF patients with severe CKD, tolvaptan use for 6 months reduced worsening of renal function and rehospitalization rates for HF when compared with conventional diuretic therapy. In conclusion, tolvaptan could be a safe and effective agent for long-term management of HF and CKD.

  15. TEACHING CLINICAL REASONING TO PHYSIOTHERAPISTS IN SAUDI ARABIA: A THEORETICAL REPORT

    Directory of Open Access Journals (Sweden)

    Mansour Abdullah Alshehri

    2017-04-01

    Full Text Available Background: Clinical reasoning (CR is an essential skill that should be taught to all healthcare professionals. In physiotherapy, it is a cognitive process whereby physiotherapists collect and assess patient data to make a diagnosis and develop an effective treatment plan. Several teaching and learning theories have been developed and used in healthcare education. The purpose of teaching is to facilitate the learning process and the successful development of practitioners in the community. Learning is defined as a knowledge process that is developed through experience which is used to manage daily life situations. The aim of this report is to explore teaching and learning theories and strategies to teach clinical reasoning to physiotherapy students in Saudi Arabia. Discussion: Although it is challenging to completely change the teaching methods in Saudi universities due to the education system rules already in place, some modules in physiotherapy are different, as they are practical and based mainly in a clinical hospital setting. As such, certain teaching and learning theories could be employed to facilitate student teaching. Indeed, a mixed method based on several theories taking into consideration the context, culture, students’ learning styles and the type of knowledge would be most appropriate. Conclusion: There is a debate about the best theory for teaching physiotherapy students. In the context of clinical reasoning, a behaviorism approach is not suitable, in contrast, constructivism is more appropriate, and thus, Saudi physiotherapy educators should consider constructivism strategies for teaching clinical reasoning.

  16. PRIME – PRocess modelling in ImpleMEntation research: selecting a theoretical basis for interventions to change clinical practice

    Directory of Open Access Journals (Sweden)

    Pitts Nigel

    2003-12-01

    Full Text Available Abstract Background Biomedical research constantly produces new findings but these are not routinely translated into health care practice. One way to address this problem is to develop effective interventions to translate research findings into practice. Currently a range of empirical interventions are available and systematic reviews of these have demonstrated that there is no single best intervention. This evidence base is difficult to use in routine settings because it cannot identify which intervention is most likely to be effective (or cost effective in a particular situation. We need to establish a scientific rationale for interventions. As clinical practice is a form of human behaviour, theories of human behaviour that have proved useful in other similar settings may provide a basis for developing a scientific rationale for the choice of interventions to translate research findings into clinical practice. The objectives of the study are: to amplify and populate scientifically validated theories of behaviour with evidence from the experience of health professionals; to use this as a basis for developing predictive questionnaires using replicable methods; to identify which elements of the questionnaire (i.e., which theoretical constructs predict clinical practice and distinguish between evidence compliant and non-compliant practice; and on the basis of these results, to identify variables (based on theoretical constructs that might be prime targets for behaviour change interventions. Methods We will develop postal questionnaires measuring two motivational, three action and one stage theory to explore five behaviours with 800 general medical and 600 general dental practitioners. We will collect data on performance for each of the behaviours. The relationships between predictor variables (theoretical constructs and outcome measures (data on performance in each survey will be assessed using multiple regression analysis and structural equation

  17. Left ventricular fluid mechanics: the long way from theoretical models to clinical applications.

    Science.gov (United States)

    Pedrizzetti, Gianni; Domenichini, Federico

    2015-01-01

    The flow inside the left ventricle is characterized by the formation of vortices that smoothly accompany blood from the mitral inlet to the aortic outlet. Computational fluid dynamics permitted to shed some light on the fundamental processes involved with vortex motion. More recently, patient-specific numerical simulations are becoming an increasingly feasible tool that can be integrated with the developing imaging technologies. The existing computational methods are reviewed in the perspective of their potential role as a novel aid for advanced clinical analysis. The current results obtained by simulation methods either alone or in combination with medical imaging are summarized. Open problems are highlighted and perspective clinical applications are discussed.

  18. Antimicrobial coated implants in trauma and orthopaedics-A clinical review and risk-benefit analysis.

    Science.gov (United States)

    Alt, Volker

    2017-03-01

    Implant-associated infections remain a major issue in orthopaedics and antimicrobial functionalization of the implant surface by antibiotics or other anti-infective agents have gained interest. The goal of this article is to identify antimicrobial coatings, for which clinical data are available and to review their clinical need, safety profile, and their efficacy to reduce infection rates. PubMed database of the National Library of Medicine was searched for clinical studies on antimicrobial coated implants for internal fracture fixation devices and endoprostheses for bone surgery, for which study design, level of evidence, biocompatibility, development of resistance, and effectiveness to reduce infection rates were analyzed. Four different coating technologies were identified: gentamicin poly(d, l-lactide) coating for tibia nails, one high (MUTARS ® ) and one low amount silver (Agluna) technology for tumor endoprostheses, and one povidone-iodine coating for titanium implants. There was a total of 9 published studies with 435 patients, of which 7 studies were case series (level IV evidence) and 2 studies were case control studies (level III evidence). All technologies were reported with good systemic and local biocompatibility, except the development of local argyria with blue to bluish grey skin discoloration after the use of silver MUTARS ® megaendoprostheses. For the local use of gentamicin, there is contradictory data on the risk of emergence of gentamicin-resistance strains, a risk that does not seem to exist for silver and iodine based technologies. Regarding reduction of infection rates, one case control study showed a significant reduction of infection rates by Agluna silver coated tumor endoprostheses. Based on socio-economic data, there is a strong need for improvement of infection prevention and treatment strategies, including implant coatings, in fracture care, primary and revision arthroplasty, and bone tumor surgery. The reviewed gentamicin, silver

  19. Clinical Benefit of Allogeneic Melanoma Cell Lysate-Pulsed Autologous Dendritic Cell Vaccine in MAGE-Positive Colorectal Cancer Patients

    DEFF Research Database (Denmark)

    Toh, Han Chong; Wang, Who-Whong; Chia, Whay Kuang

    2009-01-01

    PURPOSE: We evaluated the clinical benefit of an allogeneic melanoma cell lysate (MCL)-pulsed autologous dendritic cell (DC) vaccine in advanced colorectal cancer patients expressing at least one of six MAGE-A antigens overexpressed by the cell line source of the lysate. EXPERIMENTAL DESIGN: DCs...... late tumor regression, yielding a clinical benefit response rate of 40% (95% CI, 22-61%). Although overall median progression-free survival was 2.4 months (95% CI, 1.9-4.1 months), five patients (25%) experienced prolonged progression-free survival (>6 months), two of whom (10%) remain progression...

  20. Nursing theory and concept development: a theoretical model of clinical nurses' intentions to stay in their current positions.

    Science.gov (United States)

    Cowden, Tracy L; Cummings, Greta G

    2012-07-01

    We describe a theoretical model of staff nurses' intentions to stay in their current positions. The global nursing shortage and high nursing turnover rate demand evidence-based retention strategies. Inconsistent study outcomes indicate a need for testable theoretical models of intent to stay that build on previously published models, are reflective of current empirical research and identify causal relationships between model concepts. Two systematic reviews of electronic databases of English language published articles between 1985-2011. This complex, testable model expands on previous models and includes nurses' affective and cognitive responses to work and their effects on nurses' intent to stay. The concepts of desire to stay, job satisfaction, joy at work, and moral distress are included in the model to capture the emotional response of nurses to their work environments. The influence of leadership is integrated within the model. A causal understanding of clinical nurses' intent to stay and the effects of leadership on the development of that intention will facilitate the development of effective retention strategies internationally. Testing theoretical models is necessary to confirm previous research outcomes and to identify plausible sequences of the development of behavioral intentions. Increased understanding of the causal influences on nurses' intent to stay should lead to strategies that may result in higher retention rates and numbers of nurses willing to work in the health sector. © 2012 Blackwell Publishing Ltd.

  1. Evaluation of the Topics of Theoretical and Clinical Courses of Operative Dentistry in General Dentistry Major: Alumni Perspectives

    Directory of Open Access Journals (Sweden)

    Fatemeh MaleknejadYazdi

    2013-01-01

    Full Text Available Introduction: Operative dentistry is one of the most useful scopes in practice of dentistry. Recognition of weaknesses of dentists in this scope is very important and general dentists are the main sources to evaluate the operative dentistry curriculum and receiving feedbacks from it. The aim of this study was to evaluate the importance of the topics of theoretical and clinical courses of operative dentistry in general dentistry major curriculum by Mashhad Dental School alumni graduating between 2006-2010. Materials & Methods: A valid and reliable questionnaire to evaluate the topics of courses in theoretical course of operative dentistry and practical course (including different restorations and number of sessions was distributed among 200 dentistry alumni. The data were reported descriptively. Results: Response rate was 75%. Most of the responders evaluated that most of theoretical topics are important (more than 50%; Practical topics were mostly sufficient and it was recommended to increase the number of extensive composite restorations. Conclusion: According to alumni point of view of importance of defferent topics in operative dentistry curriculum, revision of the curriculum is in demand with special regard to extensive and cosmetic restorations.

  2. A framework for analysis of research risks and benefits to participants in standard of care pragmatic clinical trials.

    Science.gov (United States)

    Chen, Stephanie C; Kim, Scott Yh

    2016-12-01

    Standard of care pragmatic clinical trials that compare treatments already in use could improve care and reduce costs, but there is considerable debate about the research risks of standard of care pragmatic clinical trials and how to apply informed consent regulations to such trials. We sought to develop a framework integrating the insights from opposing sides of the debate. We developed a formal risk-benefit analysis framework for standard of care pragmatic clinical trials and then applied it to key provisions of the US federal regulations. Our formal framework for standard of care pragmatic clinical trial risk-benefit analysis takes into account three key considerations: the ex ante estimates of risks and benefits of the treatments to be compared in a standard of care pragmatic clinical trial, the allocation ratios of treatments inside and outside such a trial, and the significance of some participants receiving a different treatment inside a trial than outside the trial. The framework provides practical guidance on how the research ethics regulations on informed consent should be applied to standard of care pragmatic clinical trials. Our proposed formal model makes explicit the relationship between the concepts used by opposing sides of the debate about the research risks of standard of care pragmatic clinical trials and can be used to clarify the implications for informed consent. © The Author(s) 2016.

  3. [Specific developmental language disorder: a theoretical approach to its diagnosis, aetiology and clinical symptoms].

    Science.gov (United States)

    Castro-Rebolledo, R; Giraldo-Prieto, M; Hincapié-Henao, L; Lopera, F; Pineda, D A

    This article presents an updated review about the definition, diagnostic criteria, classifications, etiology and the evolution of the specific language impairment (SLI). The specific language impairment is characterized by a developmental language delay and an impaired language, that persist over time and it is not explained by sensorial, motor and mental disabilities, neither by psycopathological disorders, socio-emotional deprivation, nor brain injury. The diagnosis is based on exclusional criteria. Some researchers propose different classifications considering the children performance in language comprehension and language production. Genetical linkage to the FOXP2 gen in the SPCH1 region of the chromosome 7 and to the chromosomes 13, 16 y 19 has been reported. The neuroimage studies have shown alterations in the volume and perfusion of some brain structures related to language. The manifestations of SLI may change during the development of the children and may disturb the self-esteem, the academic performance and the social abilities. The variability in the linguistic and cognitive performance, and the variety in the etiological findings in children with SLI, don't allow to settle the affected population as an homogeneous group. Different theoretical positions have emerged as a consequence of this condition.

  4. [Music in health promotion and therapeutic practice. Cultural, theoretical and clinical perspectives.

    Science.gov (United States)

    Mastnak, Wolfgang

    2016-12-01

    Music can serve as a shelter and music therapy can provide spaces for symbolic experience and the modification of behavioural and cognitive patterns. Explaining the power of music, ancient theories speak of an analogy between music and man. Similar views are also found in modern music therapy such as Sound Work, a voice-body-based model. Complementary to the aspect of analogy, the principle of transformation is of vital importance, such as the transitions between the five elements, the solid organs and the pentatonic scale in Chinese music therapy, for instance. Distinct modes of matter-mind-transitions define the theoretical framework of neuro-psychologically based music therapy. A triadic model encompassing neuro-endocrine, psychological and aesthetic facets explains the preventive and therapeutic effect of music in stress-associated disorders and burnout. Finally, a new voice-based model (Arion Psychovocal Therapy) is presented. Integrating anthropological theories, anatomical perspectives of movement, and artistic features it focuses on psychiatry, psycho-prevention, and public health and highlights the interdisciplinary nature of music in medicine. © Georg Thieme Verlag KG Stuttgart · New York.

  5. Estimation of bone mineral density by digital X-ray radiogrammetry: theoretical background and clinical testing

    DEFF Research Database (Denmark)

    Rosholm, A; Hyldstrup, L; Backsgaard, L

    2002-01-01

    A new automated radiogrammetric method to estimate bone mineral density (BMD) from a single radiograph of the hand and forearm is described. Five regions of interest in radius, ulna and the three middle metacarpal bones are identified and approximately 1800 geometrical measurements from these bones...... are used to obtain a BMD estimate of the distal forearm, referred to as BMDDXR (from digital X-ray radiogrammetry, DXR). The measured dimensions for each bone are the cortical thickness and the outer width, in combination with an stimate of the cortical porosity. The short-term in vivo precision of BMDDXR...... was observed to be 0.60% in a clinical study of 24 women and the in vitro variation over 12 different radiological clinics was found to be 1% of the young normal BMDDXR level. In a cohort of 416 women BMDDXR was found to be closely correlated with BMD at the distal forearm measured by dual-energy X...

  6. Tutorial: survival analysis--a statistic for clinical, efficacy, and theoretical applications.

    Science.gov (United States)

    Gruber, F A

    1999-04-01

    Current demands for increased research attention to therapeutic efficacy, efficiency, and also for improved developmental models call for analysis of longitudinal outcome data. Statistical treatment of longitudinal speech and language data is difficult, but there is a family of statistical techniques in common use in medicine, actuarial science, manufacturing, and sociology that has not been used in speech or language research. Survival analysis is introduced as a method that avoids many of the statistical problems of other techniques because it treats time as the outcome. In survival analysis, probabilities are calculated not just for groups but also for individuals in a group. This is a major advantage for clinical work. This paper provides a basic introduction to nonparametric and semiparametric survival analysis using speech outcomes as examples. A brief discussion of potential conflicts between actuarial analysis and clinical intuition is also provided.

  7. [How to become a good pediatrician: a balance between theoretical and clinical training].

    Science.gov (United States)

    Carceller, A; Blanchard, A C; Barolet, J; Alloul, S; Moussa, A; Sarquella-Brugada, G

    2009-05-01

    We review a different way of teaching medicine and pediatrics which balances theory and clinical training for undergraduate, postgraduate and during continuing education. We also discuss the role of the teacher. We recommend better evaluation of students and teacher assessments. We discuss the discrepancies and the harmonization of all Institutions involved in pediatric education. We analyze the model of teaching medicine and pediatrics in the Province of Quebec, Canada. We introduce advices on the application of skills in a pediatrics training program.

  8. Evaluation of the theoretical and clinical methods for reducing marginal leakage in resin-based composite restorative materials: A review

    Directory of Open Access Journals (Sweden)

    Mohammad Ali Keshvad

    2016-11-01

    Full Text Available Resin-based composite restorative materials  have a substantial share in dental treatments. Their esthetic has made them patients’ first choice as restorative materials. Marginal leakage is one of their problems which leads to recurrent caries and post-operative hypersensitivity. Our aim was to evaluate the theoretical and clinical methods that have been proposed in the dental literature. Around 50 articles from Pubmed, SCOPUS and google scholar were selected and categorized in 4 groups based on the selected keywords. All the studies discussed in this paper have emphasized that there is no way to eliminate the microleakage but it can be reduced by means of some approaches. On the other hand, due to the multifactorial nature and difference of oral environment and laboratory conditions, there isn’t any certain way to define precisely. It seems that there is an absolute need for more research in this field to make the relation of theoretical results and clinical findings possible.

  9. Vacuum-assisted wound closure in vascular surgery - clinical and cost benefits in a developing country

    Directory of Open Access Journals (Sweden)

    Končar Igor

    2016-01-01

    Full Text Available Background/Aim. Surgical and chronic wounds in vascular patients might contribute to limb loss and death. Vacuum-assisted closure (VAC - Kinetic Concepts, Inc. (KCI, has been increasingly used in Western Europe and the USA clinical practice for 15 years. Advantages of this method are faster wound healing, wound approximation, lower wound related treatment costs and improved quality of life during treatment. Evidence related to the usage of VAC therapy in vascular patients and cost effectiveness of VAC therapy in a developing country are lacking. The aim of this study was to explore results of VAC therapy in vascular surgery comparing to conventional methods and to test cost effects in a developing country like Serbia. Methods. All patients with wound infection or dehiscence operated at the tertiary vascular university clinic in the period from January 2011 - January 2012, were treated with VAC therapy. The primary endpoint was wound closure, while secondary endpoints were hospital stay, the number of weekly dressings, costs of wound care, working time of medical personnel. The patients were divided into groups according to the wound type and location: wound with exposed synthetic vascular implant (25%, laparotomy (13%, foot amputation (29%, major limb amputation (21%, fasciotomy (13%. The results of primary and secondary endpoint were compared with the results of conventional treatment during the previous year. Results. There was one death (1/42, 2.38% and one limb loss (1/12, 2.38% in the VAC group, and 8 deaths (8/38, 21.05% and 5 (5/38, 13.15% limb losses in the patients treated with conventional therapy. In the VAC group there was one groin bleeding (1/12, 2.38%, one groin reinfection (1/12, 2.38% and one resistance to therapy with a consequent limb loss. Costs of hospital stay (p < 0.001 and nursing time (p < 0.001 were reduced with VAC therapy in the group with exposed graft. Conclusion. VAC therapy is the effective method for care of

  10. [Theoretical and experimental principles and clinical aplications of the antiandrognes (author's transl)].

    Science.gov (United States)

    Neumann, F

    1974-01-01

    It is reported the accumulated experience over the last ten years on a synthetic gestegen with a powerful antiandrogenic action: the cyproterone acetate. The effects on androgen dependent processes like: structure and function of genital accesory glands, on skin and sebaceous glands, bone maturation and growth, libido and testicular function are reported, together with the clinical results obtained in the treatment of acne, hirsutism, sexual perversions and as male anticonceptive. The influence of cyproterone acetate on the androgen dependent embrionary processew of differentiation are also discussed as wll as the female anticonceptive action and its effects on other endocrine systems.

  11. Treatment inferred from mutations identified using massive parallel sequencing leads to clinical benefit in some heavily pretreated cancer patients.

    Science.gov (United States)

    Zick, Aviad; Peretz, Tamar; Lotem, Michal; Hubert, Ayala; Katz, Daniela; Temper, Mark; Rottenberg, Yakir; Uziely, Beatrice; Nechushtan, Hovav; Meirovitz, Amichai; Sonnenblick, Amir; Sapir, Eli; Edelman, David; Goldberg, Yael; Lossos, Alexander; Rosenberg, Shai; Fried, Iris; Finklstein, Ruth; Pikarsky, Eli; Goldshmidt, Hanoch

    2017-05-01

    Molecular portraits of numerous tumors have flooded oncologists with vast amounts of data. In parallel, effective inhibitors of central pathways have shown great clinical benefit. Together, this promises potential clinical benefits to otherwise end-stage cancer patients. Here, we report a clinical service offering mutation detection of archived samples using the ion Ampliseq cancer panel coupled with clinical consultation.A multidisciplinary think tank consisting of oncologists, molecular-biologists, genetic counselors, and pathologists discussed 67 heavily pretreated, advanced cancer patient cases, taking into account mutations identified using ion Ampliseq cancer panel, medical history, and relevant literature.The team generated a treatment plan, targeting specific mutations, for 41 out of 64 cases. Three patients died before results were available. For 32 patients, the treating oncologists chose not to include the panel recommendation in the treatment plan for various reasons. Nine patients were treated as recommended by the panel, 5 with clinical benefit, and 4 with disease progression.This study suggests that routine use of massive parallel tumor sequencing is feasible and can judiciously affect treatment decisions when coupled with multidisciplinary team-based decision making. Administration of personalized based therapies at an earlier stage of disease, expansion of genetic alterations examined, and increased availability of targeted therapies may lead to further improvement in the clinical outcome of metastatic cancer patients.

  12. Freud's 'transference': Clinical technique in the 'Rat Man' case and theoretical conceptualization compared.

    Science.gov (United States)

    Diercks, Michael

    2017-07-31

    A considerable gap exists between clinical psychoanalytic concepts and psychoanalytic practice. It can be traced back to the early beginnings of psychoanalysis and to Freud's own handling of concepts that he had developed himself. Focusing on the concept of 'transference' that Freud in several steps coined so precisely from his experiences with hysteric patients and especially from his understanding of the 'Dora' case, it can be shown that he - seen from today - could not fully apply the meaning of his own concept in the later treatment of the so-called 'Rat Man'. Freud's 'Original record of the case' is used to scrutinize his way of understanding and handling the transference with this patient. To a substantial extent transference as well as counter-transference was rather enacted than understood in this case, partly due to Freud's own personal and scientific interests and to his ambitions to use this case as a demonstration of his therapeutic approach. In order to show this, it is unavoidable to correct several blurry or even misleading passages of Strachey's translation. Findings from numerous workshops using 'comparative clinical methods' indicate that up till now we analysts - like Freud - have great difficulties in applying Freud's incredible insight that "a whole series of former psychic experiences comes alive not as the past but as the present relationship to the person of the physician" (Freud, 1905c [1901], p. 279/280, my translation). Copyright © 2017 Institute of Psychoanalysis.

  13. The effective factors on quality of theoretical and clinical education from students and teachers viewpoints in Shahrekord University of Medical Sciences

    National Research Council Canada - National Science Library

    Derakhshan SA; Montazerolzohoor F; Moradi-Pardanjany H; Zaheri A

    2016-01-01

    Background and aims: The present study was conducted to identify the effective factors on quality of theoretical and clinical education from students and teachers viewpoints in Shahrekord University of Medical Sciences (SKUMS.( Methods...

  14. Current protocols in the generation of pluripotent stem cells: theoretical, methodological and clinical considerations

    Directory of Open Access Journals (Sweden)

    Brad B Swelstad

    2009-12-01

    Full Text Available Brad B Swelstad, Candace L KerrInstitute for Cell Engineering, Department of Obstetrics and Gynecology, Johns Hopkins University, Baltimore, MA, USAAbstract: Pluripotent stem cells have been derived from various embryonic, fetal and adult sources. Embryonic stem cells (ESCs and parthenogenic ESCs (pESCs are derived from the embryo proper while embryonic germ cells (EGCs, embryonal carcinoma cells (ECCs, and germ-line stem cells (GSC are produced from germ cells. ECCs were the first pluripotent stem cell lines established from adult testicular tumors while EGCs are generated in vitro from primordial germ cells (PGCs isolated in late embryonic development. More recently, studies have also demonstrated the ability to produce GSCs from adult germ cells, known as spermatogonial stem cells. Unlike ECCs, the source of GSCs are normal, non-cancerous adult tissue. The study of these unique cell lines has provided information that has led to the ability to reprogram somatic cells into an ESC-like state. These cells, called induced pluripotent stem cells (iPSCs, have been derived from a number of human fetal and adult origins. With the promises pluripotent stem cells bring to cell-based therapies there remain several considerations that need to be carefully studied prior to their clinical use. Many of these issues involve understanding key factors regulating their generation, including those which define pluripotency. In this regard, the following article discusses critical aspects of pluripotent stem cell derivation and current issues about their therapeutic potential.Keywords: pluripotency, stem cells, derivation, human

  15. [Theoretical origin and clinical application of wrist-ankle acupuncture therapy].

    Science.gov (United States)

    Wang, Qiong; Zhou, Qinghui

    2017-05-12

    The theory of wrist-ankle acupuncture is consistent with traditional meridian-collateral theory. For example, the body divisions of wrist-ankle acupuncture are corresponding to the distribution of 12 cutaneous regions of meridians, the needling sites of it are to the running courses of 12 meridians; the indications of it are to those of 12 meridians. The needling sites of wrist-ankle acupuncture are relevant with some special acupoints of acupuncture theory. For example, the 12-needling sites of wrist-ankle acupuncture are located similar to those of 12 meridian points and have very similar indications. The needling sites of it are located in the wrist and ankle regions, in which the five- shu points are located nearby, for meridian disorders. Most luo -connecting points are located near to the needling sites of wrist-ankle acupuncture or the needle tip points to. Additionally, the needling method of wrist-ankle acupuncture is consistent with some of the subcutaneous needling methods in traditional acupuncture therapy. On the basis of the aspects mentioned above, it is explained that wrist-ankle acupuncture is the development of traditional acupuncture and cannot be independent from the traditional theories of acupuncture and meridians. It is necessary to seek for the evidence from the traditional theories of TCM. The traditional theories of TCM are summarized from clinical practice, which can be newly verified from the practice of wrist-ankle acupuncture.

  16. Awareness in Alzheimer's disease and associated dementias: theoretical framework and clinical implications.

    Science.gov (United States)

    Clare, Linda; Marková, Ivana S; Roth, Ilona; Morris, Robin G

    2011-11-01

    Awareness can be defined as a reasonable or realistic perception or appraisal of a given aspect of one's situation, functioning or performance, or of the resulting implications, expressed explicitly or implicitly. Disturbances of awareness have significant implications for people with dementia and their caregivers. The construction of awareness has been extensively studied in dementia, but a lack of conceptual and methodological clarity in this area means that few clear findings have emerged. This article presents a framework for conceptualizing awareness in people with Alzheimer's disease and associated dementias that can guide research and influence practice. This article begins by considering the general concept of awareness and the ways in which neurological damage can place constraints on awareness. Within an integrative biopsychosocial model that acknowledges the influence of neurocognitive, psychological, and social variables on awareness, challenges for empirical research on awareness in dementia are addressed, and a 'levels of awareness' framework is presented within which awareness operates at four levels of increasing complexity, providing a means of differentiating among awareness phenomena. Approaches to mapping awareness phenomena are discussed, and directions for future research and clinical practice are outlined. The levels of awareness framework should act as a stimulus to further research in this area, resulting in a more coherent understanding of the nature of awareness deficits, the implications of these for people with dementia and their caregivers, and the possibilities for targeted and effective interventions.

  17. The Ease of Language Understanding (ELU model: theoretical, empirical, and clinical advances

    Directory of Open Access Journals (Sweden)

    Jerker eRönnberg

    2013-07-01

    Full Text Available Working memory is important for online language processing during conversation. We use it to maintain relevant information, to inhibit or ignore irrelevant information, and to attend to conversation selectively. Working memory helps us to keep track of and actively participate in conversation, including taking turns and following the gist. This paper examines the Ease of Language Understanding model (i.e., the ELU model, Rönnberg, 2003; Rönnberg et al., 2008 in light of new behavioral and neural findings concerning the role of working memory capacity (WMC in uni-modal and bimodal language processing. The new ELU model is a meaning prediction system that depends on phonological and semantic interactions in rapid implicit and slower explicit processing mechanisms that both depend on WMC albeit in different ways. A revised ELU model is proposed based on findings that address the relationship between WMC and (a early attention processes in listening to speech, (b signal processing in hearing aids and its effects on short-term memory, (c inhibition of speech maskers and its effect on episodic long-term memory, (d the effects of hearing impairment on episodic and semantic long-term memory, and finally, (e listening effort. New predictions and clinical implications are outlined. Comparisons with other WMC and speech perception models are made.

  18. Clinical Pharmacology Tools and Evaluations to Facilitate Comprehensive Dose Finding in Oncology: A Continuous Risk-Benefit Approach.

    Science.gov (United States)

    Bullock, Julie M; Lin, Tiffany; Bilic, Sanela

    2017-10-01

    Targeted therapies are now considered an integral component in the treatment armamentarium for many malignancies, and the approach to developing these drugs needs to be refined from the previous cytotoxic paradigm of toxicity-guided dose finding and identification of maximum tolerated dose to a paradigm driven by target activity. Moving away from the toxicity-driven dose finding and justification model requires an integrated approach in order to adequately characterize the risk-benefit of a drug. This approach starts with understanding the importance of collecting samples for pharmacokinetic and pharmacodynamic assessments in all phases of clinical development to fully characterize the pharmacokinetics and identify covariates and then correlating exposure to key markers of safety and efficacy in pharmacometric analyses to perform a robust risk-benefit assessment and establish the right dose. In addition, for oral agents, decisions on administering the drug with respect to food can impact dose among other clinical trial outcomes such as tolerability and patient compliance. Understanding the importance of model-based drug development as a decision-making tool to support drug development through incorporation of all relevant data allows for a robust risk-benefit assessment at key decision points. Utilization of clinical pharmacology tools and assessments throughout development will provide the key components of a successful oncology development program. © 2017, The American College of Clinical Pharmacology.

  19. [Challenges for clinical trials in oncology within the scope of early benefit assessment of drugs].

    Science.gov (United States)

    Lange, Stefan

    2015-01-01

    Until May 31, 2015 the German Institute for Quality and Efficiency in Health Care (IQWiG) conducted 108 assessments for various diseases on the basis of 103 dossiers within the scope of the early benefit assessment of drugs pursuant to the Act on the Reform of the Market for Medicinal Products (AMNOG). 29 of these assessments (28 dossiers) referred to advanced stages of oncologic (including neoplastic-hematologic) diseases. In 21 of these 29 assessments (72%), IQWiG found an added benefit for at least one subpopulation or subgroup, compared to 33% with non-oncologic diseases. For oncologic diseases, the extent of benefit was classified as "major" in six assessments (21%), compared to 5% for non-oncologic disorders. In contrast, the conclusions of the oncologic studies were less certain: only one assessment provided proof (of an added benefit); for non-oncologic diseases, this was the case in eight assessments. A distinctive methodological feature of the available oncologic studies is that, as a rule, treatment switching was planned in the event of progression (normally on the basis of imaging or laboratory findings) and that shortly afterwards the follow-up of important endpoints (adverse events and patient-reported outcomes) was normally discontinued. In particular, the pre-specified option in the study protocol allowing the control group to switch treatment to the experimental intervention after progression ("protocol-permitted treatment switches") makes it extremely difficult to interpret the results beyond the outcome "progression" (or progression-free survival). This treatment switching is mostly justified by reference to ethical necessity. This, however, alleges that the experimental intervention (i. e., the new drug) is superior to the control intervention, which means that circular reasoning is unavoidable. But despite this, oncologic studies are better than their reputation. Hence, so far the results of the early benefit assessment of new drugs (regarding

  20. The communication of the radiation risk from CT in relation to its clinical benefit in the era of personalized medicine. Pt. 2. Benefits versus risk of CT

    Energy Technology Data Exchange (ETDEWEB)

    Westra, Sjirk J. [Massachusetts General Hospital, Division of Pediatric Radiology, Boston, MA (United States)

    2014-10-15

    In order to personalize the communication of the CT risk, we need to describe the risk in the context of the clinical benefit of CT, which will generally be much higher, provided a CT scan has a well-established clinical indication. However as pediatric radiologists we should be careful not to overstate the benefit of CT, being aware that medico-legal pressures and the realities of health care economics have led to overutilization of the technology. And even though we should not use previously accumulated radiation dose to a child as an argument against conducting a clinically indicated scan (the ''sunk-cost'' bias), we should consider patients' radiation history in the diagnostic decision process. As a contribution to future public health, it makes more sense to look for non-radiating alternatives to CT in the much larger group of basically healthy children who are receiving occasional scans for widely prevalent conditions such as appendicitis and trauma than to attempt lowering CT use in the smaller group of patients with chronic conditions with a limited life expectancy. When communicating the CT risk with individual patients and their parents, we should acknowledge and address their concerns within the framework of informed decision-making. When appropriate, we may express the individual radiation risk, based on estimates of summated absorbed organ dose, as an order of magnitude rather than as an absolute number, and compare this with the much larger natural cancer incidence over a child's lifetime, and with other risks in medicine and daily life. We should anticipate that many patients cannot make informed decisions on their own in this complex matter, and we should offer our guidance while maintaining respect for patient autonomy. Proper documentation of the informed decision process is important for future reference. In concert with our referring physicians, pediatric radiologists are well-equipped to tackle the complexities

  1. Benefits and harms in clinical trials of duloxetine for treatment of major depressive disorder

    DEFF Research Database (Denmark)

    Maund, Emma; Tendal, Britta; Hróbjartsson, Asbjørn

    2014-01-01

    , 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...

  2. Clinical benefit response of concurrent chemoradiotherapy with protracted 5-fluorouracil infusion in patients with locally advanced pancreatic cancer

    Energy Technology Data Exchange (ETDEWEB)

    Okusaka, Takuji; Okada, Shuichi; Ishii, Hiroshi [National Cancer Center, Tokyo (Japan). Hospital] [and others

    1998-04-01

    Pancreatic cancer is a highly virulent disease with a poor prognosis. Although objective tumor response to chemotherapy and/or radiotherapy is low, some patients show an improvement in their symptoms after treatments, without obvious tumor regression. We assessed the clinical benefit of concurrent chemoradiotherapy with protracted 5-fluorouracil infusion in patients with locally advanced pancreatic cancer. Sixteen patients were enrolled in this study. The clinical benefit response to the chemoradiotherapy was evaluated by 2 indicators, including pain (intensity of pain and consumption of morphine) and performance status. A patient was defined to be a clinical benefit responder if 1 of these 2 variables was positive, and the other variable was positive or stable. Seven patients (44%) responded. Six patients (38%) were classified as stable, and 3 (19%) as nonresponders. The survival period in responders was significantly longer than that in nonresponders and stable patients. Concurrent external-beam radiation therapy, with protracted 5-fluorouracil infusion, may be a meaningful treatment for locally advanced pancreatic cancer. (author)

  3. Dosing of ACE inhibitors in left ventricular dysfunction : Does current clinical dosing provide optimal benefit?

    NARCIS (Netherlands)

    Pinto, YM; van Geel, PP; Alkfaji, H; van Veldhuisen, DJ; van Gilst, WH

    In the present review, we discuss the role of clinical dosing of angiotensin converting enzyme (ACE) inhibitors in the treatment of left ventricular dysfunction. Although the precise mechanism of action of ACE inhibitors is still unresolved, the clinical efficacy of ACE inhibitors in the treatment

  4. Real-time feedback on nonverbal clinical communication. Theoretical framework and clinician acceptance of ambient visual design.

    Science.gov (United States)

    Hartzler, A L; Patel, R A; Czerwinski, M; Pratt, W; Roseway, A; Chandrasekaran, N; Back, A

    2014-01-01

    This article is part of the focus theme of Methods of Information in Medicine on "Pervasive Intelligent Technologies for Health". Effective nonverbal communication between patients and clinicians fosters both the delivery of empathic patient-centered care and positive patient outcomes. Although nonverbal skill training is a recognized need, few efforts to enhance patient-clinician communication provide visual feedback on nonverbal aspects of the clinical encounter. We describe a novel approach that uses social signal processing technology (SSP) to capture nonverbal cues in real time and to display ambient visual feedback on control and affiliation--two primary, yet distinct dimensions of interpersonal nonverbal communication. To examine the design and clinician acceptance of ambient visual feedback on nonverbal communication, we 1) formulated a model of relational communication to ground SSP and 2) conducted a formative user study using mixed methods to explore the design of visual feedback. Based on a model of relational communication, we reviewed interpersonal communication research to map nonverbal cues to signals of affiliation and control evidenced in patient-clinician interaction. Corresponding with our formulation of this theoretical framework, we designed ambient real-time visualizations that reflect variations of affiliation and control. To explore clinicians' acceptance of this visual feedback, we conducted a lab study using the Wizard-of-Oz technique to simulate system use with 16 healthcare professionals. We followed up with seven of those participants through interviews to iterate on the design with a revised visualization that addressed emergent design considerations. Ambient visual feedback on non- verbal communication provides a theoretically grounded and acceptable way to provide clinicians with awareness of their nonverbal communication style. We provide implications for the design of such visual feedback that encourages empathic patient

  5. Physical Therapist Students' Perceptions from Performing Strength and Conditioning Training: Academic, Professional, and Clinical Benefits.

    Science.gov (United States)

    Meiners, Kelly M; Wisdom, Christina M

    2017-01-01

    The purpose of this qualitative study was to assess the perceptions of Doctor of Physical Therapy (DPT) students in performing collegiate athletes' strength and conditioning training. Four DPT students with the Certified Strength and Conditioning Specialist (CSCS) credential voluntarily provided collegiate athletes strength and conditioning training. Students were interviewed to obtain their perceptions of how the experience impacted performance in DPT school and perceptions of anticipated future benefits. Seven themes emerged from interviews: improved communication skills, movement analysis experience, improved time management/organization, increased understanding of exercises, attention to psychosocial aspects, interprofessional experience, and improved performance in coursework. DPT students with the CSCS credential perceived benefits from performing strength and conditioning training outside the standard DPT curriculum.

  6. Effect of amitriptyline vs. physiotherapy in management of fibromyalgia syndrome: What predicts a clinical benefit?

    Directory of Open Access Journals (Sweden)

    Joshi M

    2009-01-01

    Full Text Available Context : Fibromyalgia is a chronic disabling condition, and physicians treat it using a number of different treatment modalities. It is not known if one or more of such modalities are better than the others. We compared the efficacy of physiotherapy and amitriptyline in disability reduction in patients of fibromyalgia syndrome in a rural tertiary care hospital in Central India. Design : Open-label alternate patient treatment allocation. Materials and Methods : A six-month follow-up was done to assess the benefit of amitriptyline and physiotherapy for disability reduction in patients with fibromyalgia syndrome. Primary outcome measure was improvement in fibromyalgia impact questionnaire (FIQ score. Statistical Analysis Used : Predictors of benefit were determined using multivariate logistic regression. Results : A total of 175 outpatients were assigned to either amitriptyline (n=87 or structured physiotherapy (n=88 treatments. There was a significant but similar (P=0.82 improvement in disability in both groups. High FIQ score at baseline and low socioeconomic status scores were significant predictors of benefit. Conclusions : Therapy with amitriptyline or physiotherapy is equally effective in improving outcome in patients of fibromyalgia over a period of six months.

  7. Clinical Benefit in Response to Palbociclib Treatment in Refractory Uterine Leiomyosarcomas with a Common CDKN2A Alteration.

    Science.gov (United States)

    Elvin, Julia A; Gay, Laurie M; Ort, Rita; Shuluk, Joseph; Long, Jennifer; Shelley, Lauren; Lee, Ronald; Chalmers, Zachary R; Frampton, Garrett M; Ali, Siraj M; Schrock, Alexa B; Miller, Vincent A; Stephens, Philip J; Ross, Jeffrey S; Frank, Richard

    2017-04-01

    Uterine leiomyosarcoma (uLMS) responds poorly to conventional chemotherapeutic agents, and personalized therapies have yet to be systematically explored. Comprehensive genomic profiling (CGP) can identify therapeutic targets and provide insight into the biology of this highly aggressive tumor. We report a case of uLMS treated with the CGP-matched therapy palbociclib, a CDK4/6 inhibitor, with sustained clinical benefit in this rare and deadly malignancy. This study analyzed 279 clinically advanced/recurrent uLMS samples. Median patient age was 54 years (range, 23-83 years). DNA was extracted from 40 µm of formalin-fixed, paraffin-embedded sections, and CGP was performed on hybridization-captured, adaptor ligation-based libraries for up to 405 cancer-related genes plus introns from up to 31 genes frequently rearranged in cancer. Sequencing data were analyzed for base pair substitutions, insertions/deletions, copy number alterations, and rearrangements. CGP shows that 97.1% of uLMS harbor at least one alteration, and approximately 57% harbor alterations in one or more therapeutically targetable pathways. CDKN2A mutations that inactivate p16INK4a were identified in 11% of uLMS. We report the first demonstration of clinical benefit in response to palbociclib treatment for a uLMS patient with a CDKN2A mutation, resulting in disease stabilization and significant symptom reduction. A patient with uLMS harboring a CDKN2A mutation experienced clinical benefit from treatment with palbociclib, and genomic analysis of 279 uLMS samples revealed that 19% of patients had mutations affecting the cyclin-dependent kinase (CDK) pathway. These observations provide a rationale for a clinical trial investigating treatment with CDK pathway inhibitors for uLMS harboring relevant genomic alterations. The Oncologist 2017;22:416-421Implications for Practice: Comprehensive genomic profiling (CGP) of individuals with uterine leiomyosarcoma (uLMS) indicates that nearly 20% of patients may

  8. Clinical criteria for predicting benefit of ICD/PM in post myocardial infarction patients: an AVID and CAST analysis.

    Science.gov (United States)

    Hallstrom, Alfred P; Wyse, D George; McAnulty, John

    2008-12-01

    Three clinical factors from the Antiarrhythmics Versus Implantable Defibrillators (AVID) trial-heart failure, left ventricular dysfunction and certain historical features defined a subgroup in which an implantable cardioverter defibrillator (ICD/PM) has a mortality advantage over amiodarone. These three factors were jointly evaluated in the AVID cohort with ischemic heart disease (IHD) and the results applied in placebo-treated post-infarction patients in the cardiac arrhythmia suppression trial (CAST). Similar predictive power was noted in AVID patients with IHD. In CAST the factors defined three groups; one group (5.8%), corresponding to AVID patients that had high risk and benefited from an ICD/PM and another group (17.2%) corresponding to patients in AVID where the risk was moderate and ICD/PM and amiodarone had equal efficacy, demonstrated a two-fold higher risk of sudden arrhythmic than non-arrhythmic death and hence would be expected to benefit from antiarrhythmia therapy. The third group, corresponding to AVID patients with low risk of arrhythmia, demonstrated similar and low risks of sudden arrhythmic and non-arrhythmic death. Thus this group (77%) is unlikely to benefit from indiscriminate antiarrhythmia therapy. Onset of risk of death in CAST patients was offset from randomization by 3 to 6 months. Readily available clinical criteria identify a small group likely to benefit from an ICD/PM after recent myocardial infarction (MI) and the remainder unlikely to benefit from nonselective ICD/PM therapy. Additional risk stratification should focus on the latter patients and be timed to allow ICD/PM implantation between 2 and 6 months after MI.

  9. Cost and economic benefit of clinical decision support systems for cardiovascular disease prevention: a community guide systematic review.

    Science.gov (United States)

    Jacob, Verughese; Thota, Anilkrishna B; Chattopadhyay, Sajal K; Njie, Gibril J; Proia, Krista K; Hopkins, David P; Ross, Murray N; Pronk, Nicolaas P; Clymer, John M

    2017-05-01

    This review evaluates costs and benefits associated with acquiring, implementing, and operating clinical decision support systems (CDSSs) to prevent cardiovascular disease (CVD). Methods developed for the Community Guide were used to review CDSS literature covering the period from January 1976 to October 2015. Twenty-one studies were identified for inclusion. It was difficult to draw a meaningful estimate for the cost of acquiring and operating CDSSs to prevent CVD from the available studies ( n  = 12) due to considerable heterogeneity. Several studies ( n  = 11) indicated that health care costs were averted by using CDSSs but many were partial assessments that did not consider all components of health care. Four cost-benefit studies reached conflicting conclusions about the net benefit of CDSSs based on incomplete assessments of costs and benefits. Three cost-utility studies indicated inconsistent conclusions regarding cost-effectiveness based on a conservative $50,000 threshold. Intervention costs were not negligible, but specific estimates were not derived because of the heterogeneity of implementation and reporting metrics. Expected economic benefits from averted health care cost could not be determined with confidence because many studies did not fully account for all components of health care. We were unable to conclude whether CDSSs for CVD prevention is either cost-beneficial or cost-effective. Several evidence gaps are identified, most prominently a lack of information about major drivers of cost and benefit, a lack of standard metrics for the cost of CDSSs, and not allowing for useful life of a CDSS that generally extends beyond one accounting period.

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

    Science.gov (United States)

    2014-10-28

    demonstrate that a subset of viewers with clinically normal binocular and stereoscopic vision may have difficulty performing depth-related tasks on S3D...Stereopsis, Binocular Vision , Optometry, Depth Perception, 3D vision , 3D human factors, Stereoscopic displays, S3D, Virtual environment 16...subset of viewers with clinically normal binocular and stereoscopic vision may have difficulty performing depth-related tasks on S3D displays. The

  11. Clinical leadership: evaluating the benefits of action learning using co-operative inquiry

    OpenAIRE

    Rosser, Elizabeth; Reeve, J.; Neale, D.; C. Smith; Valentine, J; Grey, R

    2016-01-01

    Background: Developing clinical leadership, to ensure the culture of care is strengthened, is the thrust of the ‘leading with compassion’ campaign by the English National Health Service (NHS) (NHS England, 2014). Senior clinicians are charged with invigorating compassionate leadership yet the roles of nurse and therapist consultants the most senior clinical role in the UK healthcare system, are often solitary ones, in which they are expected to embrace a myriad of responsibilities and where t...

  12. Review of nanomaterials in dentistry: interactions with the oral microenvironment, clinical applications, hazards, and benefits.

    OpenAIRE

    Besinis, A; De Peralta, T; Tredwin, CJ; Handy, RD

    2015-01-01

    Interest in the use of engineered nanomaterials (ENMs) as either nanomedicines or dental materials/devices in clinical dentistry is growing. This review aims to detail the ultrafine structure, chemical composition, and reactivity of dental tissues in the context of interactions with ENMs, including the saliva, pellicle layer, and oral biofilm; then describes the applications of ENMs in dentistry in context with beneficial clinical outcomes versus potential risks. The flow rate and quality of ...

  13. Primary palliative care clinic pilot project demonstrates benefits of a nurse practitioner-directed clinic providing primary and palliative care.

    Science.gov (United States)

    Owens, Darrell; Eby, Kerry; Burson, Sean; Green, Meghan; McGoodwin, Wendy; Isaac, Margaret

    2012-01-01

    The purpose of the Primary Palliative Care Pilot Project was to determine if patients with a life-limiting illness who receive their primary care and palliative care from a consistent provider via a nurse practitioner (NP)-founded and-directed Primary Palliative Care Clinic at a public hospital would have improved symptom management and decreased emergency department utilization over time. All patients followed in the Harborview Primary Palliative Care Clinic from January to March 2010. The results of this project demonstrate that patients with a life-limiting illness who receive their primary care and palliative care in an NP-founded and -directed Primary Palliative Care Clinic have decreased utilization of the emergency department, and some experience improvement in symptom assessment scores. Palliative care providers and administrators should explore opportunities to expand outpatient palliative care clinics with an emphasis on primary care and continuity of care. NPs by experience and education are ideally suited to manage both primary and palliative care needs for people at the end of life. ©2011 The Author(s) Journal compilation ©2011 American Academy of Nurse Practitioners.

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

    Science.gov (United States)

    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. Copyright © 2013. Published by Elsevier Ltd.

  15. Benefits of a Transfer Clinic in Adolescent and Young Adult Kidney Transplant Patients

    Directory of Open Access Journals (Sweden)

    Rory F. McQuillan

    2015-12-01

    Full Text Available Background: Adolescent and young adult kidney transplant recipients have worse graft outcomes than older and younger age groups. Difficulties in the process of transition, defined as the purposeful, planned movement of adolescents with chronic health conditions from child to adult-centered health care systems, may contribute to this. Improving the process of transition may improve adherence post-transfer to adult care services. Objective: The purpose of this study is to investigate whether a kidney transplant transfer clinic for adolescent and young adult kidney transplant recipients transitioning from pediatric to adult care improves adherence post-transfer. Methods: We developed a joint kidney transplant transfer clinic between a pediatric kidney transplant program, adult kidney transplant program, and adolescent medicine at two academic health centers. The transfer clinic facilitated communication between the adult and pediatric transplant teams, a face-to-face meeting of the patient with the adult team, and a meeting with the adolescent medicine physician. We compared the outcomes of 16 kidney transplant recipients transferred before the clinic was established with 16 patients who attended the clinic. The primary outcome was a composite measure of non-adherence. Non-adherence was defined as either self-reported medication non-adherence or displaying two of the following three characteristics: non-attendance at clinic, non-attendance for blood work appointments, or undetectable calcineurin inhibitor levels within 1 year post-transfer. Results: The two groups were similar at baseline, with non-adherence identified in 43.75 % of patients. Non-adherent behavior in the year post-transfer, which included missing clinic visits, missing regular blood tests, and undetectable calcineurin inhibitor levels, was significantly lower in the cohort which attended the transfer clinic (18.8 versus 62.5 %, p = 0.03. The median change in estimated glomerular

  16. Benefits of Exercise on the Executive Functions in People with Parkinson Disease: A Controlled Clinical Trial.

    Science.gov (United States)

    de Oliveira, Renata Terra; Felippe, Lilian Assunção; Bucken Gobbi, Lilian Teresa; Barbieri, Fabio Augusto; Christofoletti, Gustavo

    2017-05-01

    We have made a 3-arm trial (group vs. individual exercise vs. no treatment) to test the effects of a 6-month exercise program upon the executive functions in participants with Parkinson disease. Twenty-four subjects were randomly allocated in 3 groups and undertook individualized exercises (G1, n = 8), group exercises (G2, n = 8), or monitoring (G3, n = 8). Executive functions were evaluated by means of the Wisconsin card sorting test and the Raven colored matrices, both assessed at the beginning of the program and after 6 months. The statistical analyses consisted of the application of repeated measurement tests, with a significant level of 5%. The findings showed similar behavior of groups in terms of the Wisconsin card sorting test (P = 0.792), reporting no benefit of the program on such instrument. Differently, Raven colored matrices evidenced a significant benefit provided by the intervention (P = 0.032). Compared with the control group, individuals from G1 had a substantial improvement on executive functions (P = 0.031) and from G2 had a trend of significance (P = 0.072). Findings of this study show that 6 months of exercise improved some aspects of executive functions when compared with control peers. Individual therapy seems to have a more prominent improvement than group therapy.

  17. Motor Cortical Plasticity Relates to Symptom Severity and Clinical Benefit From Deep Brain Stimulation in Cervical Dystonia.

    Science.gov (United States)

    Kroneberg, Daniel; Plettig, Philip; Schneider, Gerd-Helge; Kühn, Andrea A

    2017-09-29

    To investigate the relationship between motor cortical plasticity, intracortical inhibition, and clinical response to pallidal deep brain stimulation (DBS) in patients with cervical dystonia (CD). Response to paired associative stimulation (PAS) and short interval intracortical inhibition (SICI) were assessed in patients with CD before and after three months of DBS and correlated with severity of dystonic symptoms as assessed by Toronto-Western-Spasmodic Torticollis Rating Scale (TWSTRS) severity score. Relations of electrophysiological parameters with clinical improvement were explored with correlation analysis. Patients with higher levels of plasticity before surgery showed higher symptom severity (R = 0.83, p = 0.008) but had also the larger clinical benefit following DBS (R = 0.88, p = 0.003). This correlation was independent from preoperative (preOP) TWSTRS motor score as revealed by partial correlation analysis. Intracortical inhibition was not altered in CD and not related to clinical outcome after DBS. Our findings indicate that a high degree of preOP plasticity is associated with higher symptom severity, underlining the role of abnormal plasticity in the pathophysiology of dystonia. At the same time individual degree of plasticity may drive reestablishment of normal motor programs, leading to better clinical outcome with DBS. The latter suggests that individual PAS-response may indicate the susceptibility for neuromodulatory processes as an important factor for clinical DBS effects. It might therefore serve as a neurophysiological marker to predict outcome and guide patient selection. © 2017 International Neuromodulation Society.

  18. A multi-center, double blind clinical trial comparing benefit from three commonly used hearing aid circuits.

    Science.gov (United States)

    Larson, Vernon D; Williams, David W; Henderson, William G; Luethke, Lynn E; Beck, Lucille B; Noffsinger, Douglas; Bratt, Gene W; Dobie, Robert A; Fausti, Stephen A; Haskell, George B; Rappaport, Bruce Z; Shanks, Janet E; Wilson, Richard H

    2002-08-01

    Although numerous studies have demonstrated that hearing aids provide significant benefit, carefully controlled, multi-center clinical trials have not been conducted. A multi-center clinical trial was conducted to compare the efficacy of three commonly used hearing aid circuits: peak clipping, compression limiting, and wide dynamic range compression. Patients (N = 360) with bilateral, sensorineural hearing loss were studied using a double blind, three-period, three-treatment crossover design. The patients were fit with each of three programmable hearing aid circuits. Outcome tests were administered in the unaided condition at baseline and then after 3 mo usage of each circuit, the tests were administered in both aided and unaided conditions. The outcome test battery included tests of speech recognition, sound quality and subjective scales of hearing aid benefit, including patients' overall rank-order rating of the three circuits. Each hearing aid circuit improved speech recognition markedly, with greater improvement observed for soft and conversationally loud speech in both quiet and noisy listening conditions. In addition, a significant reduction in the problems encountered in communication was observed. Some tests suggested that the two compression hearing aids provided a better listening experience than the peak clipping hearing aid. In the rank-order ratings, patients preferred the compression limiting hearing aid more frequently than the other two hearing aids. The three hearing aid circuits studied provide significant benefit both in quiet and in noisy listening situations. The two compression hearing aids appear to provide superior benefits compared to the linear circuit, although the differences between the hearing aids were smaller than the differences between unaided and aided conditions.

  19. ORIGINAL ARTICLE PACS: Do clinical users benefit from it as a ...

    African Journals Online (AJOL)

    to evaluate user-perceptions in order to improve on good system .... 2009 and May 2009 to evaluate the effects that the integrated PACS had ... clinical users. The majority (45%) of clinicians felt that their pre-existing computer proficiency was good (Fig. 4). When asked to comment on their perceived use of the PACS, 43.4% ...

  20. [A clinical monitoring tool for diabetic patients for the benefit of freelance nurses].

    Science.gov (United States)

    Lhuillier, Odile; Adain, Emmanuiel

    2012-04-01

    The major role in prevention and therapeutic education played by freelance nurses is essential in the face of the prevalence of diabetes in Reunion.This role can only be developed using multi-disciplinary and shared clinical monitoring tools. A growing number of freelance nurses are using a newly created traceability sheet,specifically designed to reflect those requirements.

  1. 76 FR 1620 - Trials to Verify and Describe Clinical Benefit of Midodrine Hydrochloride; Establishment of...

    Science.gov (United States)

    2011-01-11

    ... hypotension. DATES: Submit either electronic or written comments by July 11, 2011. ADDRESSES: Submit... hypotension. Since that time, FDA has approved five generic versions of this product. Orthostatic hypotension...-threatening illnesses based on adequate and well-controlled clinical trials establishing that the drug has an...

  2. Clinical benefit of gluten-free diet in screen-detected older celiac disease patients

    Directory of Open Access Journals (Sweden)

    Vilppula Anitta

    2011-12-01

    Full Text Available Abstract Background The utility of serologic screening for celiac disease is still debatable. Evidence suggests that the disorder remains undetected even in the older population. It remains obscure whether screening makes good or harm in subjects with long-standing gluten ingestion. We evaluated whether older subjects benefit from active detection and subsequent gluten free dietary treatment of celiac disease. Methods Thirty-five biopsy-proven patients aged over 50 years had been detected by serologic mass screening. We examined the disease history, dietary compliance, symptoms, quality of life and bone mineral density at baseline and 1-2 years after the commencement of a gluten-free diet. Symptoms were evaluated by gastrointestinal symptom rating scale and quality of life by psychological general well-being questionnaires. Small bowel biopsy, serology, laboratory parameters assessing malabsorption, and bone mineral density were investigated. Results Dietary compliance was good. The patients had initially low mean serum ferritin values indicating subclinical iron deficiency, which was restored by a gluten-free diet. Vitamin B12, vitamin D and erythrocyte folic acid levels increased significantly on diet. Celiac patients had a history of low-energy fractures more often than the background population, and the diet had a beneficial effect on bone mineral density. Alleviation in gastrointestinal symptoms was observed, even though the patients reported no or only subtle symptoms at diagnosis. Quality of life remained unchanged. Of all the cases, two thirds would have been diagnosed even without screening if the family history, fractures or concomitant autoimmune diseases had been taken carefully into account. Conclusions Screen-detected patients benefited from a gluten-free diet. We encourage a high index of suspicion and active case-finding in celiac disease as an alternative to mass screening in older patients.

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

    Science.gov (United States)

    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.

  4. Benefits, Barriers, and Motivators to Training Dietetic Interns in Clinical Settings: A Comparison between Preceptors and Nonpreceptors.

    Science.gov (United States)

    AbuSabha, Rayane; Muller, Colette; MacLasco, Jacqueline; George, Mary; Houghton, Erica; Helm, Alison

    2017-10-27

    The shortage of supervised practice sites in dietetics is associated with fewer numbers of preceptors available to supervise interns, especially in the clinical setting. To identify clinical dietitians' perceived benefits and challenges of training dietetic interns and to determine key motivators that would entice nonpreceptors to volunteer for the role. Registered dietitian nutritionists working in clinical settings completed a semi-structured, audiotaped interview followed by a brief questionnaire. Clinical dietitians working in hospitals, long-term care facilities, and outpatient clinics (n=100) participated: 54 preceptors and 46 nonpreceptors. Qualitative analysis was conducted using an iterative process to identify and code common themes. T tests were used to compare mean differences between the opinions of preceptors and nonpreceptors. Preceptors had approximately 5 more years of experience (mean=14.27±12.09 years) than nonpreceptors (mean=8.83±9.72 years) (P< 0.01). Furthermore, preceptors reported twice as many benefits to mentoring interns (mean=6.7 mentions/participant) as nonpreceptors (mean=3.4 mentions/participant), including knowledge gains and staying current. Lack of time was consistently noted as a barrier in interviews and rated as the greatest barrier in the survey. Both groups rated receiving continuing professional education units (CPEUs) for precepting as the greatest potential motivator for taking on interns. Incentive programs should be developed to entice nonpreceptors to take on interns. These programs should include extensive training on the preceptor role and how to alleviate the burden of time spent supervising interns and should provide a significant number of CPEUs to make the added workload worthwhile. Copyright © 2017 Academy of Nutrition and Dietetics. Published by Elsevier Inc. All rights reserved.

  5. Rapid response predicts 12-month post-treatment outcomes in binge-eating disorder: theoretical and clinical implications

    Science.gov (United States)

    Grilo, C. M.; White, M. A.; Wilson, G. T.; Gueorguieva, R.; Masheb, R. M.

    2011-01-01

    Background We examined rapid response in obese patients with binge-eating disorder (BED) in a clinical trial testing cognitive behavioral therapy (CBT) and behavioral weight loss (BWL). Method Altogether, 90 participants were randomly assigned to CBT or BWL. Assessments were performed at baseline, throughout and post-treatment and at 6- and 12-month follow-ups. Rapid response, defined as ≥70% reduction in binge eating by week four, was determined by receiver operating characteristic curves and used to predict outcomes. Results Rapid response characterized 57% of participants (67% of CBT, 47% of BWL) and was unrelated to most baseline variables. Rapid response predicted greater improvements across outcomes but had different prognostic significance and distinct time courses for CBT versus BWL. Patients receiving CBT did comparably well regardless of rapid response in terms of reduced binge eating and eating disorder psychopathology but did not achieve weight loss. Among patients receiving BWL, those without rapid response failed to improve further. However, those with rapid response were significantly more likely to achieve binge-eating remission (62% v. 13%) and greater reductions in binge-eating frequency, eating disorder psychopathology and weight loss. Conclusions Rapid response to treatment in BED has prognostic significance through 12-month follow-up, provides evidence for treatment specificity and has clinical implications for stepped-care treatment models for BED. Rapid responders who receive BWL benefit in terms of both binge eating and short-term weight loss. Collectively, these findings suggest that BWL might be a candidate for initial intervention in stepped-care models with an evaluation of progress after 1 month to identify non-rapid responders who could be advised to consider a switch to a specialized treatment. PMID:21923964

  6. Electronically implemented clinical indicators based on a data warehouse in a tertiary hospital: its clinical benefit and effectiveness.

    Science.gov (United States)

    Yoo, Sooyoung; Kim, Seok; Lee, Kee-Hyuck; Jeong, Chang Wook; Youn, Sang Woong; Park, Kyoung Un; Moon, So Young; Hwang, Hee

    2014-07-01

    Assessing and monitoring care and service using clinical indicators (CIs) can allow the measurement of and lead to improvements in the quality of care. However, the management and maintenance of CI data has been shown to be difficult because the data are usually collected and provided manually. In this study, for the purpose of efficient managing quality indicators, a data warehouse (DW)-based CI monitoring system was developed. The clinical effectiveness and efficiency of a DW-based CI monitoring was investigated through several case studies of the system's operation at a tertiary hospital. This study analyzed the CIs that have been developed over the past 8 years at a 1340-bed tertiary general university hospital in South Korea to improve and monitor the quality of care and patient safety. The hospital was opened as a fully digital hospital in 2003, and the CIs were computerized in 2005 by implementing a DW-based CI monitoring system. We classified the computerized CIs and evaluated the monitoring results for several representative CIs, such as the optimal prescribing of preventive antibiotics, the average length of stay, the mortality rate, and the rehospitalization rate. During the development of the system in 2005, 12 of 19 CIs were computerized, and this number gradually increased until 299 of 335 CIs were computerized by 2012. In addition, among the CIs built computationally through the CI task force team, focal CIs subject to monitoring were selected annually, and the results of this monitoring were shared with all of the staff or the related department and its staff. By providing some examples of our CI monitoring results, we showed the feasibility of improving the quality of care, and maintaining the optimum level of patient care with less labor. The results of this study provide evidence regarding the clinical effectiveness and efficiency as well as the systems operation experience of a DW-based CI monitoring system. These findings may aid medical

  7. Estimated clinical benefit of protecting neurogenesis in the developing brain during radiation therapy for pediatric medulloblastoma

    DEFF Research Database (Denmark)

    Blomstrand, M.; Berthelsen, Anne Kiil; Munck af Rosenschöld, Per Martin

    2012-01-01

    .6%-51.2%) with IMAT, IMRT, and IMPT, respectively, while maintaining at least 95% of the prescribed dose in 95% of the whole-brain target volume. Estimated risks for developing memory impairment after a prescribed dose of 23.4 Gy were 47% (95% confidence interval [CI], 21%-69%), 44% (95% CI, 21%-65%), 41% (95% CI, 22......-modulated proton therapy, thus making this an attractive option to be tested in a prospective clinical trial....

  8. [Who benefits from the night clinic? - Value of a part-time treatment facility].

    Science.gov (United States)

    Stutz, Constanze; Kawohl, Wolfram; Platz, Christoph; Warnke, Ingeborg; Jäger, Matthias

    2017-12-01

    The night clinic which is part of the psychiatric department of the University of Zurich is a part-time treatment option with psychiatric treatment and support in the evening. This study aimed to characterize the patients and detect different functions of the treatment setting. Data of 253 patients covering a six-year period from 2008 up to 2013 were retrospectively assessed using descriptive methods. Subgroups according to the situation before admission and after discharge were compared. Patients admitted from home differed considerably from those who were transferred from a psychiatric ward concerning sociodemographic and clinical factors. They were more frequently single, unemployed, received disability funds and suffered from a psychotic disorder. They were also more likely to be discharged in a supported housing condition. The night clinic serves as an alternative to full inpatient treatment for individuals who have work as well as a rehabilitative option for homeless patients with severe mental illness. It contributes to a reduction of avoidance of inpatients stays for those groups of patients.

  9. Clinical Correlates of Benefit From Radium-223 Therapy in Metastatic Castration Resistant Prostate Cancer.

    Science.gov (United States)

    Alva, Ajjai; Nordquist, Luke; Daignault, Stephanie; George, Saby; Ramos, Jorge; Albany, Costantine; Isharwal, Sudhir; McDonald, Matthew; Campbell, Gregory; Danchaivijitr, Pongwut; Yentz, Sarah; Anand, Aseem; Yu, Evan Y

    2017-04-01

    We sought to identify potential clinical variables associated with outcomes after radium-223 therapy in routine practice. Consecutive non-trial mCRPC patients who received ≥1 dose of radium dichloride-223 at four academic and one community urology-specific cancer centers from May 2013 to June 2014 were retrospectively identified. Association of baseline and on-therapy clinical variables with number of radium doses received and clinical outcomes including overall survival were analyzed using chi-square statistics, cox proportional hazards, and Kaplan-Meier methods. Bone Scan Index (BSI) was derived from available bone scans using EXINI software. One hundred and forty-five patients were included. Radium-223 was administered for six cycles in 74 patients (51%). One-year survival in this heavily pre-treated population was 64% (95%CI: 54-73%). In univariate and multivariate analysis, survival was highly associated with receiving all six doses of Radium-223. Receipt of six doses was associated with ECOG PS of 0-1, lower baseline PSA & pain level, no prior abiraterone/enzalutamide, radium-223. Radium-223 therapy is well tolerated with most patients reporting declines in pain scores and BSI. Prostate 77:479-488, 2017. © 2016 Wiley Periodicals, Inc. © 2016 Wiley Periodicals, Inc.

  10. Clinically Viable Gene Expression Assays with Potential for Predicting Benefit from MEK Inhibitors.

    Science.gov (United States)

    Brant, Roz; Sharpe, Alan; Liptrot, Tom; Dry, Jonathan R; Harrington, Elizabeth A; Barrett, J Carl; Whalley, Nicky; Womack, Christopher; Smith, Paul; Hodgson, Darren R

    2017-03-15

    Purpose: To develop a clinically viable gene expression assay to measure RAS/RAF/MEK/ERK (RAS-ERK) pathway output suitable for hypothesis testing in non-small cell lung cancer (NSCLC) clinical studies. Experimental Design: A published MEK functional activation signature (MEK signature) that measures RAS-ERK functional output was optimized for NSCLC in silico NanoString assays were developed for the NSCLC optimized MEK signature and the 147-gene RAS signature. First, platform transfer from Affymetrix to NanoString, and signature modulation following treatment with KRAS siRNA and MEK inhibitor, were investigated in cell lines. Second, the association of the signatures with KRAS mutation status, dynamic range, technical reproducibility, and spatial and temporal variation was investigated in NSCLC formalin-fixed paraffin-embedded tissue (FFPET) samples. Results: We observed a strong cross-platform correlation and modulation of signatures in vitro Technical and biological replicates showed consistent signature scores that were robust to variation in input total RNA; conservation of scores between primary and metastatic tumor was statistically significant. There were statistically significant associations between high MEK ( P = 0.028) and RAS ( P = 0.003) signature scores and KRAS mutation in 50 NSCLC samples. The signatures identify overlapping but distinct candidate patient populations from each other and from KRAS mutation testing. Conclusions: We developed a technically and biologically robust NanoString gene expression assay of MEK pathway output, compatible with the quantities of FFPET routinely available. The gene signatures identified a different patient population for MEK inhibitor treatment compared with KRAS mutation testing. The predictive power of the MEK signature should be studied further in clinical trials. Clin Cancer Res; 23(6); 1471-80. ©2016 AACR See related commentary by Xue and Lito, p. 1365 . ©2016 American Association for Cancer Research.

  11. Clinical and economic benefit of general practitioner integration to a symptomatic breast service.

    Science.gov (United States)

    Beecher, S M; Donlan, C; O'Leary, D P; Kerin, M J; McLaughlin, R

    2016-11-01

    Integration of general practitioners (GPs) into a tertiary care team is a model used internationally to assist with provision of patient care. Symptomatic breast clinics have seen significant increases in attendances and consequential staffing issues. We wished to analyze the integration of GPs into a tertiary breast care team and establish whether their inclusion is a cost-effective approach. A prospectively maintained database was used to identify 1614 new and 1453 review patients seen in the clinic between September and December 2013. The triple assessment clinical, radiological, and biopsy scores of patients assessed by GPs were compared to those assessed by registrars and to the overall number of patients seen. A cost analysis was performed based on the hourly rates of GPs and registrars. 1614 new patients seen over the 4-month period. GPs reviewed a mean of 153.6 new patients and registrars reviewed a mean of 97.8. Registrars reviewed patients who were allocated higher 'S' scores, with 46 % of patients allocated an S4 and 21 % of patients allocated an S5 score. GPs reviewed a mean of 115.6 return patients and registrars reviewed a mean of 110.1 return patients. The weekly cost of employing 3 GPs for 15 h was €835. This compares favorably to the cost of employing a full-time registrar. This study demonstrates that GPs can play a substantial role in the provision of a symptomatic breast service. In addition, the incorporation of GPs in this setting can prove cost-effective.

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

    Science.gov (United States)

    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

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

    Directory of Open Access Journals (Sweden)

    Cunningham Frances C

    2012-11-01

    Full Text Available Abstract 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

  14. Analyzing the 'nature' and 'specific effectiveness' of clinical empathy: a theoretical overview and contribution towards a theory-based research agenda.

    NARCIS (Netherlands)

    Neumann, M.; Bensing, J.; Mercer, S.; Ernstmann, N.; Ommen, O.; Pfaff, H.

    2009-01-01

    OBJECTIVE: To establish sound empirical evidence that clinical empathy (abbreviated as CE) is a core element in the clinician-patient relationship with profound therapeutic potential, a substantial theoretical-based understanding of CE in medical care and medical education is still required. The two

  15. Clinician-Reported Outcome Assessments of Treatment Benefit: Report of the ISPOR Clinical Outcome Assessment Emerging Good Practices Task Force.

    Science.gov (United States)

    Powers, John H; Patrick, Donald L; Walton, Marc K; Marquis, Patrick; Cano, Stefan; Hobart, Jeremy; Isaac, Maria; Vamvakas, Spiros; Slagle, Ashley; Molsen, Elizabeth; Burke, Laurie B

    2017-01-01

    A clinician-reported outcome (ClinRO) assessment is a type of clinical outcome assessment (COA). ClinRO assessments, like all COAs (patient-reported, observer-reported, or performance outcome assessments), are used to 1) measure patients' health status and 2) define end points that can be interpreted as treatment benefits of medical interventions on how patients feel, function, or survive in clinical trials. Like other COAs, ClinRO assessments can be influenced by human choices, judgment, or motivation. A ClinRO assessment is conducted and reported by a trained health care professional and requires specialized professional training to evaluate the patient's health status. This is the second of two reports by the ISPOR Clinical Outcomes Assessment-Emerging Good Practices for Outcomes Research Task Force. The first report provided an overview of COAs including definitions important for an understanding of COA measurement practices. This report focuses specifically on issues related to ClinRO assessments. In this report, we define three types of ClinRO assessments (readings, ratings, and clinician global assessments) and describe emerging good measurement practices in their development and evaluation. The good measurement practices include 1) defining the context of use; 2) identifying the concept of interest measured; 3) defining the intended treatment benefit on how patients feel, function, or survive reflected by the ClinRO assessment and evaluating the relationship between that intended treatment benefit and the concept of interest; 4) documenting content validity; 5) evaluating other measurement properties once content validity is established (including intra- and inter-rater reliability); 6) defining study objectives and end point(s) objectives, and defining study end points and placing study end points within the hierarchy of end points; 7) establishing interpretability in trial results; and 8) evaluating operational considerations for the implementation of

  16. The benefits and challenges of using computer-assisted symptom assessments in oncology clinics: results of a qualitative assessment.

    Science.gov (United States)

    Mark, Tami L; Johnson, Gina; Fortner, Barry; Ryan, Katheryn

    2008-10-01

    Developed for clinical use in oncology settings, the Patient Assessment, Care & Education (PACE) System is a computer technology tool designed to address the under-identification and treatment of chemotherapy-related symptoms. This system includes general core questions together with the Patient Care Monitor (PCM), a validated questionnaire that assesses patient-reported problems, six symptom burden indices, and one global quality of life index. The system automatically scores the PCM and generates a written report. The objective of this study was to assess the manner in which clinicians use this system and identify the benefits and challenges that oncology clinics may face when adopting this system. The study was part of a larger evaluation of the system that included standardized surveys and chart review. Sixteen providers (physicians, nurses, and physician assistants) at 13 community oncology clinics participated in a 30-minute interview. Responses were coded according to common phrases or concepts. Clinicians indicated that they use the system mainly for symptom assessment or review of systems. The most common benefits identified included the improved ability to identify under-reported symptoms, enhanced communication with patients; increased efficiency; and its ability to highlight patients' most bothersome symptoms. Challenges included patient burden from the frequent need to answer the questionnaires, issues with the wording and formatting of the screening questionnaire, and technical difficulties. In sum, these interviews suggest that electronic symptom assessments offer potential advantages in terms improving the integration of routine assessment of patients' symptoms and health-related quality of life into the daily flow of an oncology clinic. The approach should receive additional research and development attention.

  17. The use of phototherapy in the management of TMJ pain: clinical evidence of benefits and limitations

    Science.gov (United States)

    Pinheiro, A. L. B.; Soares, A. P.; Marques, A. M. C.; de Carvalho, F. B.; Soares, L. G. P.; de Oliveira, S. C. P. S.; Cangussú, M. C. T.

    2017-02-01

    Temporomandibular disorders - TMDs are common painful multifactorial conditions affecting the temporomandibular joint whose treatment depends on the type and symptoms. Initially it requires pain control and for this, drugs, biting plates, occlusal adjustment, physiotherapy or their association are used. Laser-phototherapy (LPT) has been used on the treatment of pain of several origins including TMDs. It is known that wavelength, energy density, frequency of application influences the outcome of many clinical protocols. This work reports a series of patients of the Center of Biophotonics of the Federal University of Bahia over 15 years. Following standard anamneses, clinical and imaginologic examination and with the diagnosis of any type of TMD, the patients were set for light treatment. Treatment consisted of three sessions a week during six week. Prior irradiation, the patients were asked to score their pain using a VAS. IR and/or Red diode lasers were used on each session. The medical records of 432 patients (73 male and 359 female) suffering from TMJ disorders were revised. Most patients were female ( 47.9 years old). At the end of the 12 sessions the patients were again examined and score their pain using VAS. No other intervention was carried out during the treatment. The results were statistically analyzed and showed that 51.16 % of the patients were asymptomatic or improved after treatment. It is concluded that LPT was effective on pain reduction on TMJ disorders of several origins.

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

    Science.gov (United States)

    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.

  19. The health benefits and constraints of exercise therapy for wheelchair users: A clinical commentary

    Directory of Open Access Journals (Sweden)

    Terry J. Ellapen

    2017-01-01

    Full Text Available Background: There are approximately 1 billion people living with chronic lower limb disability, many of whom are wheelchair users.Objectives: Review cardiometabolic and neuromuscular risk profiles of wheelchair users, benefits of regular exercise and the causes of neuromuscular upper limb and hip injuries that hinder regular adherence.Method: Literature published between 2013 and 2017 was adopted according to the standard practices for systematic reviews (PRISMA through Crossref Metadata and Google Scholar searches. Individual paper quality was evaluated using a modified Downs and Black Appraisal Scale.Results: The literature search identified 16 600 papers which were excluded if they were non-English, non-peer-reviewed or published before 2013. Finally, 25 papers were accepted, indicating that sedentary wheelchair users have poor cardiometabolic risk profiles (PCMRP because of a lack of physical activity, limiting their quality of life, characterised by low self-esteem, social isolation and depression. Their predominant mode of physical activity is through upper limb exercises, which not only improves their cardiometabolic risk profiles but also precipitates neuromuscular upper limb overuse injuries. The primary cause of upper limb injuries was attributed to poor wheelchair propulsion related to incorrect chair setup and poor cardiorespiratory fitness.Conclusion: Wheelchair users have a high body mass index, body fat percentage and serum lipid, cholesterol and blood glucose concentrations. Empirical investigations illustrate exercise improves their PCMRP and cardiorespiratory fitness levels. Although literature encourages regular exercise, none discusses the need to individualise chair setup in order to eliminate wheelchair pathomechanics and upper limb neuromuscular injuries. Wheelchair users must be encouraged to consult a biokineticist or physiotherapist to review their wheelchair setup so as to eliminate possible incorrect manual wheelchair

  20. Herpes Simplex Encephalitis: Lack of Clinical Benefit of Long-term Valacyclovir Therapy.

    Science.gov (United States)

    Gnann, John W; Sköldenberg, Birgit; Hart, John; Aurelius, Elisabeth; Schliamser, Silvia; Studahl, Marie; Eriksson, Britt-Marie; Hanley, Daniel; Aoki, Fred; Jackson, Alan C; Griffiths, Paul; Miedzinski, Lil; Hanfelt-Goade, Diane; Hinthorn, Daniel; Ahlm, Clas; Aksamit, Allen; Cruz-Flores, Salvador; Dale, Ilet; Cloud, Gretchen; Jester, Penelope; Whitley, Richard J

    2015-09-01

    Despite the proven efficacy of acyclovir (ACV) therapy, herpes simplex encephalitis (HSE) continues to cause substantial morbidity and mortality. Among patients with HSE treated with ACV, the mortality rate is approximately 14%-19%. Among survivors, 45%-60% have neuropsychological sequelae at 1 year. Thus, improving therapeutic approaches to HSE remains a high priority. Following completion of a standard course of intravenous ACV, 87 adult patients with HSE (confirmed by positive polymerase chain reaction [PCR] for herpes simplex virus DNA in cerebrospinal fluid) were randomized to receive either valacyclovir (VACV) 2 g thrice daily (n = 40) or placebo tablets (n = 47) for 90 days (12 tablets of study medication daily). The primary endpoint was survival with no or mild neuropsychological impairment at 12 months, as measured by the Mattis Dementia Rating Scale (MDRS). Logistic regression was utilized to assess factors related to the primary endpoint. The demographic characteristics of the 2 randomization groups were statistically similar with no significant differences in age, sex, or race. At 12 months, there was no significant difference in the MDRS scoring for VACV-treated vs placebo recipients, with 85.7% and 90.2%, respectively, of patients demonstrating no or mild neuropsychological impairment (P = .72). No significant study-related adverse events were encountered in either treatment group. Following standard treatment with intravenous ACV for PCR-confirmed HSE, an additional 3-month course of oral VACV therapy did not provide added benefit as measured by neuropsychological testing 12 months later in a population of relatively high-functioning survivors. NCT00031486. © The Author 2015. Published by Oxford University Press on behalf of the Infectious Diseases Society of America. All rights reserved. For Permissions, please e-mail: journals.permissions@oup.com.

  1. The Clinical Benefits and Accuracy of Continuous Glucose Monitoring Systems in Critically Ill Patients—A Systematic Scoping Review

    Directory of Open Access Journals (Sweden)

    Sigrid C. J. van Steen

    2017-01-01

    Full Text Available Continuous Glucose Monitoring (CGM systems could improve glycemic control in critically ill patients. We aimed to identify the evidence on the clinical benefits and accuracy of CGM systems in these patients. For this, we performed a systematic search in Ovid MEDLINE, from inception to 26 July 2016. Outcomes were efficacy, accuracy, safety, workload and costs. Our search retrieved 356 articles, of which 37 were included. Randomized controlled trials on efficacy were scarce (n = 5 and show methodological limitations. CGM with automated insulin infusion improved time in target and mean glucose in one trial and two trials showed a decrease in hypoglycemic episodes and time in hypoglycemia. Thirty-two articles assessed accuracy, which was overall moderate to good, the latter mainly with intravascular devices. Accuracy in critically ill children seemed lower than in adults. Adverse events were rare. One study investigated the effect on workload and cost, and showed a significant reduction in both. In conclusion, studies on the efficacy and accuracy were heterogeneous and difficult to compare. There was no consistent clinical benefit in the small number of studies available. Overall accuracy was moderate to good with some intravascular devices. CGM systems seemed however safe, and might positively affect workload and costs.

  2. Percutaneous left atrial appendage closure for stroke prevention in patients with atrial fibrillation: an assessment of net clinical benefit.

    Science.gov (United States)

    Gangireddy, Sandeep R; Halperin, Jonathan L; Fuster, Valentin; Reddy, Vivek Y

    2012-11-01

    The PROTECT-AF (WATCHMAN Left Atrial Appendage System for Embolic Protection in Patients with Atrial Fibrillation) trial found left atrial appendage (LAA) closure an alternative to anticoagulation in selected patients with non-valvular atrial fibrillation (AF). We aim to estimate the net clinical benefit (NCB) of percutaneous LAA closure. Post hoc analysis of outcomes among 707 adults with AF in the PROTECT-AF trial and 566 in the Continued Access (CAP) registry undergoing LAA closure with the Watchman device compared with sustained anticoagulation. Outcomes were ischaemic stroke, intracranial haemorrhage, major bleeding, pericardial effusion, and death, weighted to reflect the relative impact in terms of death and disability. Net clinical benefit was calculated as the sum of annualized rates of these outcomes after intervention minus rates on warfarin. The NCB of LAA closure during 1623 person-years follow-up in the trial was 1.73%/year (95% CI: -0.54 to 4.39%/year) and during 741 patient-years in the registry was 4.97%/year (95% CI: 3.07-7.15%/year). Among patients with a history of ischaemic stroke, the NCB was greater in the registry (8.68%/year, CI: 2.82-14.92%/year) than the trial (4.30%/year, CI -2.07 to 11.25%/year). In the registry, the NCB of LAA closure increased from 2.22%/year (CI: 0.27-6.01%/year) in patients with CHADS(2) scores = 1 to 6.12%/year (CI: 3.19-8.92%/year) in those with scores ≥2. Combining rates of thrombo-embolism, intracranial haemorrhage, major adverse events, and death allows objective comparison of the benefit and risk of device therapy vs. anticoagulation in patients with AF. The NCB of LAA closure is greatest for patients at a higher risk of stroke.

  3. How Can We Realize the Clinical Benefits of Continuous Glucose Monitoring?

    Science.gov (United States)

    Ajjan, Ramzi A

    2017-05-01

    Controlling glycemia in diabetes remains key to prevent complications in this condition. However, glucose levels can undergo large fluctuations secondary to daily activities, consequently creating management difficulties. The current review summarizes the basics of glucose management in diabetes by addressing the main glycemic parameters. The advantages and limitation of HbA1c, the gold standard measure of glucose control, are discussed together with the clinical importance of hypoglycemia and glycemic variability. The review subsequently moves focus to glucose monitoring techniques in diabetes, assessing advantages and limitations. Monitoring glucose levels is crucial for effective and safe adjustment of hypoglycemic therapy, particularly in insulin users. Self-monitoring of blood glucose (SMBG), based on capillary glucose testing, remains one of the most widely used methods to monitor glucose levels, given the relative accuracy, familiarity, and manageable costs. However, patient inconvenience and the sporadic nature of SMBG limit clinical effectiveness of this approach. In contrast, continuous glucose monitoring (CGM) provides a more comprehensive picture of glucose levels, but these systems are expensive and require constant calibration which, together with concerns over accuracy of earlier devices, restrict CGM use to special groups of patients. The newer flash continuous glucose monitoring (FCGM) system, which is more affordable than conventional CGM devices and does not require calibration, offers an alternative glucose monitoring strategy that comprehensively analyzes glucose profile while sparing patients the inconvenience of capillary glucose testing for therapy adjustment or CGM calibration. The fast development of new CGM devices will gradually displace SMBG as the main glucose testing method. Avoiding the inconvenience of SMBG and optimizing glycemia through alternative glucose testing strategies will help to reduce the risk of complications and

  4. How a modified approach to dental coding can benefit personal and professional development with improved clinical outcomes.

    Science.gov (United States)

    Lam, Raymond; Kruger, Estie; Tennant, Marc

    2014-12-01

    One disadvantage of the remarkable achievements in dentistry is that treatment options have never been more varied or confusing. This has made the concept of Evidenced Based Dentistry more applicable to modern dental practice. Despite merit in the concept whereby clinical decisions are guided by scientific evidence, there are problems with establishing a scientific base. This is no more challenging than in modern dentistry where the gap between rapidly developing products/procedures and its evidence base are widening. Furthermore, the burden of oral disease continues to remain high at the population level. These problems have prompted new approaches to enhancing research. The aim of this paper is to outline how a modified approach to dental coding may benefit clinical and population level research. Using publically assessable data obtained from the Australian Chronic Disease Dental Scheme and item codes contained within the Australian Schedule of Dental Services and Glossary, a suggested approach to dental informatics is illustrated. A selection of item codes have been selected and expanded with the addition of suffixes. These suffixes provided circumstantial information that will assist in assessing clinical outcomes such as success rates and prognosis. The use of item codes in administering the CDDS yielded a large database of item codes. These codes are amenable to dental informatics which has been shown to enhance research at both the clinical and population level. This is a cost effective method to supplement existing research methods. Copyright © 2014 Elsevier Inc. All rights reserved.

  5. Transplanted bone marrow mononuclear cells and MSCs impart clinical benefit to children with osteogenesis imperfecta through different mechanisms

    Science.gov (United States)

    Otsuru, Satoru; Gordon, Patricia L.; Shimono, Kengo; Jethva, Reena; Marino, Roberta; Phillips, Charlotte L.; Hofmann, Ted J.; Veronesi, Elena; Dominici, Massimo; Iwamoto, Masahiro

    2012-01-01

    Transplantation of whole bone marrow (BMT) as well as ex vivo–expanded mesenchymal stromal cells (MSCs) leads to striking clinical benefits in children with osteogenesis imperfecta (OI); however, the underlying mechanism of these cell therapies has not been elucidated. Here, we show that non–(plastic)–adherent bone marrow cells (NABMCs) are more potent osteoprogenitors than MSCs in mice. Translating these findings to the clinic, a T cell–depleted marrow mononuclear cell boost (> 99.99% NABMC) given to children with OI who had previously undergone BMT resulted in marked growth acceleration in a subset of patients, unambiguously indicating the therapeutic potential of bone marrow cells for these patients. Then, in a murine model of OI, we demonstrated that as the donor NABMCs differentiate to osteoblasts, they contribute normal collagen to the bone matrix. In contrast, MSCs do not substantially engraft in bone, but secrete a soluble mediator that indirectly stimulates growth, data which provide the underlying mechanism of our prior clinical trial of MSC therapy for children with OI. Collectively, our data indicate that both NABMCs and MSCs constitute effective cell therapy for OI, but exert their clinical impact by different, complementary mechanisms. The study is registered at www.clinicaltrials.gov as NCT00187018. PMID:22829629

  6. Understanding the positive benefit:risk profile of alemtuzumab in relapsing multiple sclerosis: perspectives from the Alemtuzumab Clinical Development Program

    Directory of Open Access Journals (Sweden)

    Havrdova E

    2017-10-01

    Full Text Available Eva Havrdova,1 Jeffrey A Cohen,2 Dana Horakova,1 Ivana Kovarova,1 Eva Meluzinova3 1Department of Neurology and Center of Clinical Neuroscience, First Faculty of Medicine, Charles University and General University Hospital in Prague, Prague, Czech Republic; 2Neurological Institute, Cleveland Clinic, Cleveland, OH, USA; 3Department of Neurology, Second Faculty of Medicine, Charles University, Motol University Hospital, Prague, Czech Republic Abstract: The introduction of high-efficacy therapies for relapsing–remitting multiple sclerosis has driven re-evaluation of treatment goals and benefit:risk considerations in treatment choice. In the alemtuzumab Phase II and III clinical trials, patients treated with alemtuzumab 12 mg versus subcutaneous interferon beta-1a demonstrated significantly reduced annualized relapse rates and improved magnetic resonance imaging outcomes, and were significantly more likely to achieve no evidence of disease activity and reduction in brain volume loss. In two of the studies, alemtuzumab-treated patients had a significantly reduced risk of 6-month confirmed disease worsening, compared with subcutaneous interferon beta-1a. Benefits were maintained throughout 5 years, with a majority of patients receiving no alemtuzumab retreatment or other disease-modifying therapy. Trial results support alemtuzumab’s manageable, consistent safety profile in relapsing–remitting multiple sclerosis. Infusion-associated reactions, the most frequent adverse events (AEs, can be minimized by corticosteroid pretreatment, monitoring, and symptomatic management. Other AEs include infections and autoimmune events. Oral anti-herpes prophylaxis should be initiated on the first day of each alemtuzumab treatment course and continued according to local guidelines. Overall cancer risk was lower in the alemtuzumab clinical trials than in a reference population; however, continuing surveillance will determine if alemtuzumab may be associated with

  7. Clinical benefits of incorporating doxycycline into a canine heartworm treatment protocol

    Directory of Open Access Journals (Sweden)

    C. Thomas Nelson

    2017-11-01

    Full Text Available Abstract Background The objective of heartworm treatment is to improve the clinical condition of the patient and to eliminate pre-cardiac, juvenile, and adult worm stages with minimal complications. Pulmonary thromboembolisms are an inevitable consequence of worm death and can result in severe pulmonary reactions and even death of the patient. To minimize these reactions, various treatment protocols involving melarsomine, the only adulticidal drug approved by the US Food and Drug Administrations (FDA, in conjunction with macrocyclic lactone heartworm preventives and glucocorticosteroids have been advocated. The discovery of the bacterial endosymbiont Wolbachia in Dirofilaria immitis has led to several experimental studies examining the effects of administering doxycycline to reduce or eliminate Wolbachia organism. These studies have shown a decrease in gross and microscopic pathology of pulmonary parenchyma in experimental heartworm infections pretreated with doxycycline before melarsomine administration. Methods Electronic medical records from a large veterinary practice in northeast Alabama were searched to identify dogs treated for heartworms with melarsomine from January 2005 through December 2012. The search was refined further to select for dogs that met the following criteria: 1 received two or three doses of ivermectin heartworm preventive prior to melarsomine injections, 2 received one injection of melarsomine followed by two injections 4 to 8 weeks later, and 3 were treated with prednisone following melarsomine injections. The dogs were then divided into those that also were treated with doxycycline 10 mg/kg BID for 4 weeks (Group A, n = 47 and those that did not receive doxycycline (Group B, n = 47. The medical notes of all 94 cases were then reviewed for comments concerning coughing, dyspnea, or hemoptysis in the history, physical exam template, or from telephone conversations with clients the week following each visit. Any

  8. Clinical benefits of incorporating doxycycline into a canine heartworm treatment protocol.

    Science.gov (United States)

    Nelson, C Thomas; Myrick, Elizabeth S; Nelson, Thomas A

    2017-11-09

    The objective of heartworm treatment is to improve the clinical condition of the patient and to eliminate pre-cardiac, juvenile, and adult worm stages with minimal complications. Pulmonary thromboembolisms are an inevitable consequence of worm death and can result in severe pulmonary reactions and even death of the patient. To minimize these reactions, various treatment protocols involving melarsomine, the only adulticidal drug approved by the US Food and Drug Administrations (FDA), in conjunction with macrocyclic lactone heartworm preventives and glucocorticosteroids have been advocated. The discovery of the bacterial endosymbiont Wolbachia in Dirofilaria immitis has led to several experimental studies examining the effects of administering doxycycline to reduce or eliminate Wolbachia organism. These studies have shown a decrease in gross and microscopic pathology of pulmonary parenchyma in experimental heartworm infections pretreated with doxycycline before melarsomine administration. Electronic medical records from a large veterinary practice in northeast Alabama were searched to identify dogs treated for heartworms with melarsomine from January 2005 through December 2012. The search was refined further to select for dogs that met the following criteria: 1) received two or three doses of ivermectin heartworm preventive prior to melarsomine injections, 2) received one injection of melarsomine followed by two injections 4 to 8 weeks later, and 3) were treated with prednisone following melarsomine injections. The dogs were then divided into those that also were treated with doxycycline 10 mg/kg BID for 4 weeks (Group A, n = 47) and those that did not receive doxycycline (Group B, n = 47). The medical notes of all 94 cases were then reviewed for comments concerning coughing, dyspnea, or hemoptysis in the history, physical exam template, or from telephone conversations with clients the week following each visit. Any dog that died within one year of treatment

  9. A Review of the Biochemistry, Metabolism and Clinical Benefits of Thiamin(e and Its Derivatives

    Directory of Open Access Journals (Sweden)

    Derrick Lonsdale

    2006-01-01

    Full Text Available Thiamin(e, also known as vitamin B1, is now known to play a fundamental role in energy metabolism. Its discovery followed from the original early research on the ‘anti-beriberi factor’ found in rice polishings. After its synthesis in 1936, it led to many years of research to find its action in treating beriberi, a lethal scourge known for thousands of years, particularly in cultures dependent on rice as a staple. This paper refers to the previously described symptomatology of beriberi, emphasizing that it differs from that in pure, experimentally induced thiamine deficiency in human subjects. Emphasis is placed on some of the more unusual manifestations of thiamine deficiency and its potential role in modern nutrition. Its biochemistry and pathophysiology are discussed and some of the less common conditions associated with thiamine deficiency are reviewed. An understanding of the role of thiamine in modern nutrition is crucial in the rapidly advancing knowledge applicable to Complementary Alternative Medicine. References are given that provide insight into the use of this vitamin in clinical conditions that are not usually associated with nutritional deficiency. The role of allithiamine and its synthetic derivatives is discussed. Thiamine plays a vital role in metabolism of glucose. Thus, emphasis is placed on the fact that ingestion of excessive simple carbohydrates automatically increases the need for this vitamin. This is referred to as high calorie malnutrition.

  10. [Medical short stay unit for geriatric patients in the emergency department: clinical and healthcare benefits].

    Science.gov (United States)

    Pareja, Teresa; Hornillos, Mercedes; Rodríguez, Miriam; Martínez, Javier; Madrigal, María; Mauleón, Coro; Alvarez, Bárbara

    2009-01-01

    To evaluate the impact of comprehensive geriatric assessment and management of high-risk elders in a medical short stay unit located in the emergency department of a general hospital. We performed a descriptive, prospective study of patients admitted to the medical short stay unit for geriatric patients of the emergency department in 2006. A total of 749 patients were evaluated, with a mean (standard deviation) stay in the unit of 37 (16) h. The mean age was 86 (7) years; 57% were women, and 50% had moderate-severe physical impairment and dementia. Thirty-five percent lived in a nursing home. The most frequent reason for admission was exacerbation of chronic cardiopulmonary disease. Multiple geriatric syndromes were identified. The most frequent were immobility, pressure sores and behavioral disorders related to dementia. Seventy percent of the patients were discharged to home after being stabilized and were followed-up by the geriatric clinic and day hospital (39%), the home care medical team (11%), or the nursing home or primary care physician (20%). During the month after discharge, 17% were readmitted and 7.7% died, especially patients with more advanced age or functional impairment. After the unit was opened, admissions to the acute geriatric unit fell by 18.2%. Medical short stay units for geriatric patients in emergency departments may be useful for geriatric assessment and treatment of exacerbations of chronic diseases. These units can help to reduce the number of admissions and optimize the care provided in other ambulatory and domiciliary geriatric settings.

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

    Science.gov (United States)

    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

  12. Clinical outcomes and immune benefits of anti-epileptic drug therapy in HIV/AIDS

    Directory of Open Access Journals (Sweden)

    Krentz Hartmut B

    2010-06-01

    Full Text Available Abstract Background Anti-epileptic drugs (AEDs are frequently prescribed to persons with HIV/AIDS receiving combination antiretroviral therapy (cART although the extent of AED use and their interactions with cART are uncertain. Herein, AED usage, associated toxicities and immune consequences were investigated. Methods HIV replication was analysed in proliferating human T cells during AED exposure. Patients receiving AEDs in a geographically-based HIV care program were assessed using clinical and laboratory variables in addition to assessing AED indication, type, and cumulative exposures. Results Valproate suppressed proliferation in vitro of both HIV-infected and uninfected T cells (p 0.05 but AED exposures did not affect HIV production in vitro. Among 1345 HIV/AIDS persons in active care between 2001 and 2007, 169 individuals were exposed to AEDs for the following indications: peripheral neuropathy/neuropathic pain (60%, seizure/epilepsy (24%, mood disorder (13% and movement disorder (2%. The most frequently prescribed AEDs were calcium channel blockers (gabapentin/pregabalin, followed by sodium channel blockers (phenytoin, carbamazepine, lamotrigine and valproate. In a nested cohort of 55 AED-treated patients receiving cART and aviremic, chronic exposure to sodium and calcium channel blocking AEDs was associated with increased CD4+ T cell levels (p 0.05 with no change in CD8+ T cell levels over 12 months from the beginning of AED therapy. Conclusions AEDs were prescribed for multiple indications without major adverse effects in this population but immune status in patients receiving sodium or calcium channel blocking drugs was improved.

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

    Science.gov (United States)

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

    2014-06-04

    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. Data on primary efficacy analysis and major harms extracted from each data source and compared. Nine randomised placebo controlled trials of duloxetine (total 2878 patients) submitted to the European Medicines Agency (EMA) for marketing approval for major depressive disorder. 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. 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. Clinical study reports contained extensive data on major harms that were unavailable in journal articles and in trial registry reports. There

  14. No clinical quantifiable benefits between non-surgical and surgical endodontic treatment.

    Science.gov (United States)

    Ferrailo, Debra M; Veitz-Keenan, Analia

    2017-10-27

    Data sourcesThe authors searched the following electronic databases: the Cochrane Oral Health Trials Register, the Cochrane Central Register of Controlled Trials (CENTRAL), Medline Ovid and Embase Ovid. The US National Registry of Clinical Trials (ClinicalTrials.gov) and the World Health Organisation (WHO) International Clinical Trials Registry Platform were searched for ongoing trials. There were no restrictions regarding language and publication date. The authors hand-searched the reference lists of the studies retrieved and key journals in the field of endodontics.Study selectionRandomised controlled trials (RCTs) involving people with periapical pathosis including comparison of surgical versus non-surgical treatment or different types of surgery. Outcome measures were healing of the periapical lesion assessed after one-year follow-up or longer, postoperative pain and discomfort and adverse effects such as tooth loss, mobility, soft tissue recession, abscess, infection, neurological damage or loss of root sealing material evaluated through radiographs.Data extraction and synthesisTwo review authors independently extracted data from the included studies and assessed their risk of bias. Study authors were contacted to obtain missing information. The authors combined results of trials assessing comparable outcomes using the fixed-effect model, with risk ratios (RRs) for dichotomous outcomes and mean differences (MDs) for continuous outcomes, and 95% confidence intervals (CIs) and they used generic inverse variance for split-mouth studies.ResultsThe review included 20 RCTs. Two trials at high risk of bias assessed surgery versus a non-surgical approach: root-end resection with root-end filling versus root canal retreatment. The other 18 trials evaluated different surgical protocols.There was no clear evidence of superiority in the surgical or non-surgical approach for healing at one-year follow-up (RR 1.15, 95% CI 0.97 to 1.35; two RCTs, 126 participants) or at four

  15. Barriers and benefits associated with nurses information seeking related to patient education needs on clinical nursing units.

    Science.gov (United States)

    Jones, Josette; Schilling, Katherine; Pesut, Daniel

    2011-01-01

    The purpose of this study was to answer the following two questions: What are clinical nurses' rationales for their approaches to finding patient educational materials on the web? What are perceived barriers and benefits associated with the use of web-based information resources for patient education in the context of nursing clinical practice?Over 179 individual data units were analyzed to understand clinical nurses' rationales for their approaches to find patient educational materials on the web. Rationales were defined as those underlying catalysts or activators leading to an information need. Analyses found that the primary reasons why clinical nurses conducted web-based information searches included direct patient requests ( 9 requests), colleague requests (6 requests), building patient materials collections (4), patients' family requests (3), routine teaching (1), personal development (1), or staff development (1). From these data, four broad themes emerged: professional reasons, personal reasons, technology reasons, and organization reasons for selecting information resources. Content analysis identified 306 individual data units representing either 'benefits' (178 units) or 'barriers' (128) to the nurses' use of web resources for on-unit patient care. Inter-rater reliability was assessed and found to be excellent (r = 0.943 to 0.961). The primary themes that emerged as barriers to the used of web-based resources included: 1) time requirements to perform a search, 2) nurses' experience and knowledge about the resources or required technology, 3) specific characteristics of individuals electronic information resources, and 4) organizational procedures and policies. Three primary themes that represented the benefits of using web-based resources were also identified: 1) past experiences and knowledge of a specific resource or the required technologies, 2) availability and accessibility on the unit, and 3) specific characteristics of individual information tool

  16. PACS: Do clinical users benefit from it as a training adjunct?

    Directory of Open Access Journals (Sweden)

    J van Heerden

    2011-06-01

    Full Text Available Background. Over the past four years, Steve Biko Academic Hospital has been in the process of implementing and refining the use of a picture archiving and communications system (PACS. As part of a post-implementation refining process, it is necessary to evaluate user-perceptions in order to improve on good system qualities and correct flaws. Aim. The aim of this study was to assess whether medical clinicians perceived PACS as a positive adjunct to training and teaching opportunities – specifically those opportunities related to radiological image viewing and interpretation as part of patient case discussions. Method. Standardised questionnaires with ‘free text’ and ‘option selection’ questions were distributed to clinicians who, as part of their training, rotated at Steve Biko Academic Hospital (where a PACS is in place as well as other teaching hospitals without a PACS. Between February 2009 and May 2009, approximately 400 questionnaires were distributed. As a result of constant academic rotations, leave schedules of medical staff and posts vacated, questionnaires could not be distributed to the entire target population that was estimated to be in the region of 550 medical clinicians (comprising senior medical students, interns, medical officers, registrars and consultants. Of the 400 questionnaires distributed, 189 completed questionnaires were returned. Completion of the questionnaires was voluntary and anonymous. Results and conclusion. Although a PACS relates specifically to the archiving and retrieval of radiological images and reports, it became clear from the feedback received from medical clinicians (who are ward-based, theatre-based or clinic-based users of a digital system that many other factors, such as lack of adequate hardware and sub-optimal personal IT proficiency, contributed to some of the negative PACS-related perceptions and ‘lost teaching opportunities’ reported. Negative comments specifically related to PACS

  17. Quality rating test of hearing aid benefit in the NIDCD/VA Clinical Trial.

    Science.gov (United States)

    Noffsinger, Douglas; Haskell, George B; Larson, Vernon D; Williams, David W; Wilson, Eleanor; Plunkett, Sheril; Kenworthy, Diane

    2002-08-01

    As part of a large clinical trial that compared three hearing aid circuits using several evaluation methods, judgments about quality of listening experiences were sought from all subjects. Three dimensions were examined: loudness, noise interference and overall liking (quality). Eight Audiology units in VA Medical Centers participated. Three hearing aid circuits were compared: linear peak clipper, compression limiter, and wide dynamic range compressor. The experimental design was a three-period, three-treatment crossover design. Baseline measures were made using a battery of tests in unaided conditions. Subjects (N = 360) were then stratified by participating site and randomized to one of six sequences of the three hearing aid circuits. Each circuit was fit binaurally and all subjects used each of the three circuits for 3 mo. All outcome measures were administered in unaided and aided conditions after each 3-mo period. The study used a double-blind strategy, i.e., neither the audiologist giving the tests nor the subject knew which circuit was being used. A different audiologist programmed the devices. For loudness judgments, soft and loud presentations of speech in quiet and in babble competition were judged more comfortable via the wide dynamic range circuit. The noise interference tasks and overall liking of the listening experience showed few significant differences across circuits. All circuits made the listening experience more comfortably loud for soft and conversation-level speech. Differences across circuits in terms of the overall quality of the listening experience and how noise interference was rated were small. Only isolated conditions, usually favoring the WDRC circuit, reached significance levels. The loudness dimension results were clearer. The WDRC circuit made sounds at either the loud or soft extreme more comfortable. When subjects were grouped by amount and configuration of hearing loss, the advantages for the WDRC and to a lesser extent the

  18. Association of Spinal Manipulative Therapy With Clinical Benefit and Harm for Acute Low Back Pain

    Science.gov (United States)

    Paige, Neil M.; Miake-Lye, Isomi M.; Booth, Marika Suttorp; Beroes, Jessica M.; Mardian, Aram S.; Dougherty, Paul; Branson, Richard; Tang, Baron; Morton, Sally C.

    2017-01-01

    Importance Acute low back pain is common and spinal manipulative therapy (SMT) is a treatment option. Randomized clinical trials (RCTs) and meta-analyses have reported different conclusions about the effectiveness of SMT. Objective To systematically review studies of the effectiveness and harms of SMT for acute (≤6 weeks) low back pain. Data Sources Search of MEDLINE, Cochrane Database of Systematic Reviews, EMBASE, and Current Nursing and Allied Health Literature from January 1, 2011, through February 6, 2017, as well as identified systematic reviews and RCTs, for RCTs of adults with low back pain treated in ambulatory settings with SMT compared with sham or alternative treatments, and that measured pain or function outcomes for up to 6 weeks. Observational studies were included to assess harms. Data Extraction and Synthesis Data extraction was done in duplicate. Study quality was assessed using the Cochrane Back and Neck (CBN) Risk of Bias tool. This tool has 11 items in the following domains: randomization, concealment, baseline differences, blinding (patient), blinding (care provider [care provider is a specific quality metric used by the CBN Risk of Bias tool]), blinding (outcome), co-interventions, compliance, dropouts, timing, and intention to treat. Prior research has shown the CBN Risk of Bias tool identifies studies at an increased risk of bias using a threshold of 5 or 6 as a summary score. The evidence was assessed using the Grading of Recommendations Assessment, Development, and Evaluation (GRADE) criteria. Main Outcomes and Measures Pain (measured by either the 100-mm visual analog scale, 11-point numeric rating scale, or other numeric pain scale), function (measured by the 24-point Roland Morris Disability Questionnaire or Oswestry Disability Index [range, 0-100]), or any harms measured within 6 weeks. Findings Of 26 eligible RCTs identified, 15 RCTs (1711 patients) provided moderate-quality evidence that SMT has a statistically significant

  19. Concomitant radiotherapy and chemotherapy in head and neck cancer - theoretical rationale and clinical experience; Rownoczesna radioterapia i chemioterapia nowotworow glowy i szyi - podstawy teoretyczne i doswiadczenia kliniczne

    Energy Technology Data Exchange (ETDEWEB)

    Jassem, J. [Klinika Radioterapii, Akademia Medyczna, Gdansk (Poland)

    1994-12-31

    Concomitant radiotherapy and chemotherapy in head and neck cancer aims at an interaction between the two modalities which results in improved therapeutic index. Several mechanisms by which this benefit can be achieved are presented. Reviewed are also conclusive randomized trials in which this option has been compared with radiotherapy alone as well as the reasons for difficulties in interpretation of clinical results. (author)

  20. Cognitive-behavioral therapy for schizophrenia: a critical evaluation of its theoretical framework from a clinical-phenomenological perspective

    DEFF Research Database (Denmark)

    Skodlar, Borut; Henriksen, Mads Gram; Sass, Louis

    2013-01-01

    Background: Cognitive-behavioral therapy (CBT) has played an increasingly important role in psychotherapy for schizophrenia since the 1990s, but it has also encountered many theoretical and practical limitations. For example, methodologically rigorous meta-analyses have recently found only modest...... and self-awareness frequently reported by schizophrenia patients and systematically studied in phenomenological psychopathology from the beginning of the 20th century. Results: We argue that a strong theoretical emphasis on cognitive appraisals with only subsidiary attention devoted to affective...... and behavioral processes - as is characteristic of many forms of CBT - cannot satisfactorily account for the complex subjective experiences of schizophrenia patients. We further argue that certain theoretical strategies widely employed in CBT to explore and explain mental disorders, which involve atomization and...

  1. Contractualist reasoning, HIV cure clinical trials, and the moral (ir)relevance of the risk/benefit ratio.

    Science.gov (United States)

    Kumar, Rahul

    2017-02-01

    Institutional review boards (IRB) normally require of a morally defensible clinical trial that any trial participant will benefit from the inquiry, or at least not be exposed to a significant risk of having their prospects worsened by participating. Stage 1 HIV cure trials tend not to meet this requirement. Does that show them to be morally indefensible? Utilitarian thinking about this question supports a negative answer. But one might reasonably expect a Kantian moral theory to support the conclusion that exposing trial participants to a significant risk of their prospects being worsened by their participation to be morally indefensible, on grounds that this would be a clear case of using a person as a mere means. In this paper, I argue, drawing on Kantian contractualist thinking, that requiring the risk/benefit ratio for participants be positive if a trial is to be morally defensible does not in fact gain any support from Kantian thinking about morality. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing/.

  2. The effective factors on quality of theoretical and clinical education from students and teachers viewpoints in Shahrekord University of Medical Sciences

    OpenAIRE

    Derakhshan SA; Montazerolzohoor F; Moradi-Pardanjany H; Zaheri A

    2016-01-01

    Background and aims: The present study was conducted to identify the effective factors on quality of theoretical and clinical education from students and teachers viewpoints in Shahrekord University of Medical Sciences (SKUMS.( Methods: The method to conduct this study was descriptive-survey and the study population consisted of all students and teachers in SKUMS, of whom 330 (214 female and 116 male) students and 125 (44 female and 81 male) teachers were enrolled by random, stratified sam...

  3. Clinical benefit of steroid use in patients undergoing cardiopulmonary bypass: a meta-analysis of randomized trials

    DEFF Research Database (Denmark)

    Whitlock, R.P.; Chan, S.; Devereaux, P.J.

    2008-01-01

    We sought to establish the efficacy and safety of prophylactic steroids in adult patients undergoing cardiopulmonary bypass (CPB). We performed a meta-analysis of randomized trials reporting the effects of prophylactic steroids on clinical outcomes after CPB. Outcomes examined were mortality...... randomizing 3205 patients. Steroids reduced new onset atrial fibrillation [relative risk (RR) 0.71, 95% confidence interval (CI) 0.59 to 0.87], postoperative bleeding [weighted mean difference (WMD) -99.6 mL, 95% CI -149.8 to -49.3], and duration of ICU stay (WMD -0.23 days, 95% CI -0.40 to -0.07). Length...... of hospital stay was also reduced (WMD -0.59 days, 95% CI -1.17 to -0.02), but this result was less robust. A trend towards reduction in mortality was observed (RR 0.73, 95% CI 0.45 to 1.18). Randomized trials suggest that perioperative steroids have significant clinical benefit in CPB patients by decreasing...

  4. A Novel Glycinate-based Body Wash: Clinical Investigation Into Ultra-mildness, Effective Conditioning, and Improved Consumer Benefits.

    Science.gov (United States)

    Regan, Jamie; Mollica, Leonel-Maximo; Ananthapadmanabhan, K P

    2013-06-01

    To assess the properties of a novel body wash containing the mild surfactant glycinate. Biochemical and clinical assays. Research laboratories and clinical sites in the United States and Canada. Women 18 to 65 years of age (cleansing efficacy); male and female subjects 26 to 63 years of age with mild or moderate dryness and erythema (leg-controlled application test); subjects 5 to 65 years of age with mild-to-moderate eczema (eczema compatibility); and women 18 to 64 years of age (home use). Assessments across studies included colorimetric dye exclusion to assess skin damage potential (corneosurfametry), efficacy of cosmetic product removal from skin, change from baseline in visual dryness, change from baseline in Eczema Area and Severity Index, and self-perceived eczema attributes and self-reported product preference. The glycinate-based cleanser demonstrated mildness to skin components when evaluated in a corneosurfametry assay. Short-term use under exaggerated wash conditions in subjects with dryness scores <3 and erythema scores <2 (both on a 0-6 scale) indicated an initial reduction in visual dryness. In subjects with eczema, normal use resulted in significant improvements (p<0.05) at Week 4 compared with baseline in skin dryness (change from baseline = -0.73), rash (-0.56), itch (-0.927), tightness (-0.585), and all eczema (-0.756). The glycinate-based body wash removed 56 percent of a long-lasting cosmetic foundation from skin compared with less than 30 percent removed by two competitive products tested. The glycinate-based body wash was preferred over a competitive mild cleansing product overall. The patented glycinate-containing body wash demonstrated better product mildness and patient-preferred attributes and clinical benefits.

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

    Energy Technology Data Exchange (ETDEWEB)

    Defraene, Gilles, E-mail: gilles.defraene@uzleuven.be [Radiation Oncology Department, University Hospitals Leuven, Leuven (Belgium); Van den Bergh, Laura [Radiation Oncology Department, University Hospitals Leuven, Leuven (Belgium); Al-Mamgani, Abrahim [Department of Radiation Oncology, Erasmus Medical Center - Daniel den Hoed Cancer Center, Rotterdam (Netherlands); Haustermans, Karin [Radiation Oncology Department, University Hospitals Leuven, Leuven (Belgium); Heemsbergen, Wilma [Netherlands Cancer Institute - Antoni van Leeuwenhoek Hospital, Amsterdam (Netherlands); Van den Heuvel, Frank [Radiation Oncology Department, University Hospitals Leuven, Leuven (Belgium); Lebesque, Joos V. [Netherlands Cancer Institute - Antoni van Leeuwenhoek Hospital, Amsterdam (Netherlands)

    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

  6. The clinical surveillance process as carried out by expert nurses in a critical care context: A theoretical explanation.

    Science.gov (United States)

    Milhomme, Daniel; Gagnon, Johanne; Lechasseur, Kathleen

    2018-02-01

    Nursing Science presents surveillance as an indispensable component of patient safety. Although the literature defines surveillance fully, its implementation is not well understood. This research aims to formulate a theoretical explanation of the surveillance process that expert nurses employ in critical care. To develop the theoretical explanation for the surveillance process of critical care nurses, Strauss and Corbin's (1998) grounded theory approach and Think Aloud Method (Fonteyn et al., 1993) were used with fifteen expert critical care nurses (n=15). Surveillance in critical care is a continual process of collaborative vigilance that starts with the thought process and behaviour related to data collection, analysis and interpretation. The surveillance process comprises five key elements: 1) Managing the risk of complications; 2) Collecting data; 3) Detecting a problem; 4) Making a decision and 5) Working in synergy. In developing a theoretical explanation, this research leads to an understanding of the surveillance process performed by expert nurses in a critical care context. Copyright © 2017 Elsevier Ltd. All rights reserved.

  7. The costs and benefits of extending the role of the acute pain service on clinical outcomes after major elective surgery.

    Science.gov (United States)

    Lee, Anna; Chan, Simon K C; Chen, Phoon Ping; Gin, Tony; Lau, Angel S C; Chiu, Chun Hung

    2010-10-01

    Acute pain services have received widespread acceptance and formal support from institutions and organizations, but available evidence on their costs and benefits is scarce. Although there is good agreement on the provision of acute pain services after many major surgical procedures, there are other procedures for which the benefits are unclear. Data are required to justify any expansion of acute pain services. In this randomized, controlled clinical trial we compared the costs and effects of acute pain service care on clinical outcomes with conventional pain management on the ward. Patients included in the trial were considered by their anesthesiologist to have either arm be suitable for the procedure. Four hundred twenty-three patients undergoing major elective surgery were randomized either to an anesthesiologist-led, nurse-based acute pain service group with patient-controlled analgesia or to a control group with IM or IV boluses of opioid analgesia. Both groups were treated with medications to treat opioid-related adverse effects and received the usual care from health professionals assigned to the ward. The main outcome measures were quality of recovery scores, pain intensity measures, global measure of treatment effectiveness, and overall pain treatment cost. Cost-effectiveness acceptability curves were drawn to detect a difference in the joint cost-effect relationship between groups. There was no difference in quality of recovery score on postoperative day 1 between treatment and control groups (mean difference, 0; 95% confidence interval [CI], -0.7 to 0.7; P = 0.94) or in the rate of improvement in quality of recovery score (mean difference, -0.1; 95% CI, -0.4 to 0.1; P = 0.34). The proportion of patients with 1 or more days of highly effective pain management was higher in the acute pain service group than in the control group (86% vs. 75%; P < 0.01). Costs were higher in the acute pain service group (mean difference, US$46; 95% CI, $44 to $48 per patient

  8. The clinical benefit and cost-effectiveness of human papillomavirus vaccination for adult women in the Netherlands.

    Science.gov (United States)

    Bogaards, Johannes A; Coupé, Veerle M H; Meijer, Chris J L M; Berkhof, Johannes

    2011-11-08

    The use of human papillomavirus (HPV) vaccines has been universally approved for women from age 12 to 25 years, but those older than 16 years receive no reimbursement for the cost of the vaccine in the Netherlands. Reductions in the vaccine price as well as new insights in the efficacy of HPV vaccines offer renewed arguments to consider HPV vaccination in adult women. We calculated the clinical benefit and cost-effectiveness of vaccinating women aged 17-25 years in 2010. The calculations were based on an individual-based simulation model for cervical carcinogenesis, with HPV infection risks obtained from a type-specific HPV transmission model. The indirect protective effect from vaccinating 12 to 16 year-old girls was adjusted for. Cervical screening in the model was incorporated according Dutch screening guidelines, i.e. 7 cytology-based rounds at 5-year intervals from the age of 30. As base-case, we assumed the vaccine to offer full protection against HPV16/18 only if no prior exposure to that type had occurred before vaccination. In sensitivity analyses, we considered partial cross-protection against types 31/33/45/58 and efficacy against all future infections, irrespective of previous or current infection status. In base-case analyses, vaccinating 17 year-olds reduced their lifetime risk of treatment for precancerous lesions from 7.77% to 3.48% and their lifetime cervical cancer risk from 0.52% to 0.24%. These risks were 6.12% and 0.45%, respectively, for a 25 year-old vaccinee. The incremental cost-effectiveness ratio (ICER) for vaccinating 17-25 year-olds was €22,526 per quality-adjusted life-year (QALY) at a vaccine price of €65 per dose, a 50% reduction of the 2010 pharmacy price in the Netherlands. If cross-protection against types 31/33/45/58 was included, the ICER decreased to €14,734 per QALY. Results were robust to efficacy assumptions with respect to previous or current infection status. The clinical benefit of HPV vaccination of women up to 25

  9. Challenges in the Clinical Application of the American Society of Clinical Oncology Value Framework: A Medicare Cost-Benefit Analysis in Chronic Lymphocytic Leukemia.

    Science.gov (United States)

    Seymour, Erlene K; Schiffer, Charles A; de Souza, Jonas A

    2017-11-16

    The ASCO Value Framework calculates the value of cancer therapies. Given costly novel therapeutics for chronic lymphocytic leukemia, we used the framework to compare net health benefit (NHB) and cost within Medicare of all regimens listed in the National Comprehensive Cancer Network (NCCN) guidelines. The current NCCN guidelines for chronic lymphocytic leukemia were reviewed. All referenced studies were screened, and only randomized controlled prospective trials were included. The revised ASCO Value Framework was used to calculate NHB. Medicare drug pricing was used to calculate the cost of therapies. Forty-nine studies were screened. The following observations were made: only 10 studies (20%) could be evaluated; when comparing regimens studied against the same control arm, ranking NHB scores were comparable to their preference in guidelines; NHB scores varied depending on which variables were used, and there were no clinically validated thresholds for low or high values; treatment-related deaths were not weighted in the toxicity scores; and six of the 10 studies used less potent control arms, ranked as the least-preferred NCCN-recommended regimens. The ASCO Value Framework is an important initial step to quantify value of therapies. Essential limitations include the lack of clinically relevant validated thresholds for NHB scores and lack of incorporation of grade 5 toxicities/treatment-related mortality into its methodology. To optimize its application for clinical practice, we urge investigators/sponsors to incorporate and report the required variables to calculate the NHB of regimens and encourage trials with stronger comparator arms to properly quantify the relative value of therapies.

  10. Pleiotropic benefit of monomeric and oligomeric flavanols on vascular health--a randomized controlled clinical pilot study.

    Directory of Open Access Journals (Sweden)

    Antje R Weseler

    integrative multi-biomarker approach unveiled the pleiotropic vascular health benefit of an 8 weeks supplementation with 200 mg/d MOF in humans. TRIAL REGISTRATION: ClinicalTrials.gov NCT00742287.

  11. The evaluation of the risks and benefits of phase II cancer clinical trials by institutional review board (IRB) members: a case study.

    Science.gov (United States)

    van Luijn, H E M; Aaronson, N K; Keus, R B; Musschenga, A W

    2006-03-01

    There are indications that institutional review board (IRB) members do not find it easy to assess the risks and benefits in medical experiments, although this is their principal duty. This study examined how IRB members assessed the risk/benefit ratio (RBR) of a specific phase II breast cancer clinical trial. The trial was evaluated by means of a questionnaire administered to 43 members of IRBs at six academic hospitals and specialised cancer centres in the Netherlands. The questionnaire addressed: identification and estimation of inconvenience, toxicity, psychosocial distress, and benefits of trial participation to patients; identification and estimation of benefits to future patients and medical science; assessment of the trial's RBR; and assessment of its ethical acceptability. Most IRB members expected trial participation to involve fairly or very serious inconvenience, fairly severe to sometimes life-threatening toxicity, and serious psychological and social consequences. Conversely, the perceived likelihood of benefits to patients was modest. Most regarded the study as important, and the balance between risks and benefits to be favourable, and believed that the protocol should be approved. The IRB members' final judgement on the trial's ethical acceptability was significantly correlated with their RBR assessment of the protocol. Because most patients who participate in clinical trials hope this will prolong their lives, it is suggested that patient information should better describe the anticipated benefits-for example, the likelihood of prolonging life. This would allow patients to make decisions regarding participation based on realistic expectations.

  12. Benefits of dental implants installed during ablative tumour surgery in oral cancer patients: a prospective 5-year clinical trial.

    Science.gov (United States)

    Korfage, Anke; Schoen, Pieter J; Raghoebar, Gerry M; Roodenburg, Jan L N; Vissink, Arjan; Reintsema, Harry

    2010-09-01

    This prospective study assessed treatment outcome and patient satisfaction of oral cancer patients with a mandibular overdenture on implants up to 5 years after treatment. At baseline, 50 consecutive edentulous oral cancer patients, in whom prosthetic problems were expected after oncological treatment, were evaluated by standardized questionnaires and clinical assessments. All implants were installed during ablative tumour surgery in native bone in the interforaminal area. About two-thirds of the patients (n=31) had radiotherapy post-surgery (dose >40 Gy in the interforaminal area). At the 5-year evaluation, 26 patients had passed away and four patients had to be excluded from the analyses, because superstructures were not present, due to persistent local irritation (n=2), loss of three implants (n=1) and the impossibility of making an overdenture related to tumour and oncological surgery-driven anatomical limitations (n=1). In the remaining 20 patients, the prosthesis was still in function (76 implants). During the 5-year follow-up, total 14 implants were lost, 13 in irradiated bone (survival rate 89.4%, dose >40 Gy) and one in non-irradiated bone (survival rate 98.6%). Peri-implant tissues had a healthy appearance and remained healthy over time. Patients were satisfied with their dentures. It was concluded that oral cancer patients can benefit from implants installed during ablative surgery, with a high survival rate of the implants, a high percentage of rehabilitated patients and a high denture satisfaction up to 5 years after treatment.

  13. The benefits of antiepileptic drug (AED) blood level monitoring to complement clinical management of people with epilepsy.

    Science.gov (United States)

    Stepanova, Daria; Beran, Roy G

    2015-01-01

    Some argue that there is no evidence to support the use of antiepileptic drug (AED) blood level monitoring when treating people with epilepsy (PWE). This paper identifies how AED monitoring can be invaluable in such treatment. SPECIFIC EXAMPLES: (i) Compliance: Antiepileptic drug blood levels often confirm noncompliance rather than adequate seizure control, confirming subtherapeutic levels in PWE attending hospitals due to seizures. Routine monitoring of AED levels may prevent breakthrough seizures by identifying noncompliance and instituting heightened compliance measures before experiencing breakthrough seizures without modifying dosages. For PWE attending hospitals due to seizures, loading with the AED shown to be subtherapeutic may be all that is required. (ii) Cluster seizures and status epilepticus: When using long-acting AEDs to complement benzodiazepines, blood level monitoring confirms that an adequate dosage was given and, if not, a further bolus can be administered with further monitoring. This is particularly useful when using rectal administration of AEDs. (iii) Polypharmacy: Polypharmacy provokes drug interactions in which case AED monitoring helps in differentiating adequate dosing, offending AED with toxicity and free level measuring benefits when total levels are unhelpful. (iv) Generic substitution: Generic AEDs can fluctuate considerably from a parent compound, and even a parent compound, sourced from an alternative supplier, may have altered bioavailability for which blood level monitoring is very useful. While therapeutic blood level monitoring is not a substitute for good clinical judgment, it offers a valuable adjunct to patient care. Copyright © 2014 Elsevier Inc. All rights reserved.

  14. Research and clinical practice: constructing theoretical links / Pesquisa e prática clínica: construindo articulações teóricas

    Directory of Open Access Journals (Sweden)

    Terezinha Féres-Carneiro

    2008-01-01

    Full Text Available In this text, which was presented at the Inaugural Lecture from the Graduate Program of Developmental Psychology at Universidade Federal do Rio Grande do Sul (UFRGS on March 03, 2008, are discussed the links constructed by this author in the academic work as well as in the clinical practice. The history of a 36-year journey as both a professor-researcher and also as a clinical psychologist is reported here, with emphasis on the inseparable way of conceiving such functions. In this account it is explained and discussed the possibilities of articulating different theoretical-technical approaches in the clinic. The proposal for family and couple psychological assistance is a tripartite key of reading which takes into consideration the intra-psychological, the interactional and the social aspects of the aforementioned ones.

  15. The Substantial Clinical Benefit Threshold for SRS-22R Domains After Surgical Treatment of Adult Spinal Deformity.

    Science.gov (United States)

    Crawford, Charles H; Glassman, Steven D; Bridwell, Keith H; Carreon, Leah Y

    2016-09-01

    Longitudinal cohort. To determine Substantial Clinical Benefit (SCB) thresholds for the SRS22R domains in patients undergoing adult spinal deformity surgery. The Scoliosis Research Society 22R (SRS22R) has been shown to be reliable, valid, and responsive to change in adult spinal deformity patients. Although the minimal clinically important difference (MCID) is commonly used to quantify a threshold of improvement, it could be considered a floor value rather than a goal. Patients enrolled in a prospective database of adult spinal deformity undergoing surgery with complete SRS22R preoperation and the SRS30 one-year after surgery were identified. One-year postoperative answers to the last 8 questions of the SRS30 were used as anchors to determine the SCB for the Appearance and Activity domains, Subtotal and Total Score using ROC Curve analysis. The sample population consisted of 1,422 patients; 83% were females. Mean age was 53 ± 16 years. Mean preoperative SRS22R Appearance score was 2.50 ± 0.73 improving to 3.62 ± 0.84 at one year postoperative. Mean preoperative SRS22R Activity score was 2.96 ± 0.59 improving to 3.33 ± 0.80 at one year postoperative. Mean preoperative SRS22R Pain score was 2.73 ± 0.92 improving to 3.60 ± 0.93 at one year postoperative. Mean preoperative SRS22R Subtotal was 2.56 ± 0.66 improving to 3.11 ± 0.80 at one year postoperative. There was a statistically significant difference in domain scores among the responses to the anchors (p spinal deformity population undergoing surgical treatment show SRS22R SCB values of 1.60 for Appearance, 0.87 for Activity, 0.69 for Subtotal, and 0.94 for Total score. These SCB thresholds can be used to quantify the clinical significance of health status change in the surgical management of adult spinal deformity. Level II. Copyright © 2016 Scoliosis Research Society. Published by Elsevier Inc. All rights reserved.

  16. Risks of thromboembolism and bleeding with thromboprophylaxis in patients with atrial fibrillation: A net clinical benefit analysis using a 'real world' nationwide cohort study

    DEFF Research Database (Denmark)

    Olesen, Jonas Bjerring; Lip, Gregory Y H; Lindhardsen, Jesper

    2011-01-01

    . There was a neutral or positive net clinical benefit (ischaemic stroke vs. intracranial haemorrhage) with VKA alone in patients with a CHADS2 score of = 0, and CHA2DS2-VASc score of = 1. This large cohort study confirms the efficacy of VKA and no effect of ASA treatment on the risk of stroke/thromboembolism. Also......, the risk of bleeding was increased with both VKA and ASA treatment, but the net clinical benefit was clearly positive, in favour of VKA in patients with increased risk of stroke/thromboembolism....

  17. Economic Cost of Ovine Johne’s Disease in Clinically Affected New Zealand Flocks and Benefit-Cost of Vaccination

    Directory of Open Access Journals (Sweden)

    Milan Gautam

    2018-01-01

    Full Text Available The aims of this study were to estimate the on-fam economic cost of ovine Johne’s disease (OJD based on collected incidence and mortality data, and the benefit-cost of OJD vaccination in typical OJD affected flocks in New Zealand after having vaccinated for a number of years. Owners of 20 sheep breeding and finishing farms known to be clinically affected by ovine Johne’s disease in New Zealand participated in the study and were monitored for up to two years. Farms were categorized as fine-wool (Merino, Half-Bred, Corriedale, n = 15, and other breeds (Romney, composite breeds, n = 5. Ovine JD was confirmed by gross- and histo-pathology in 358 ewes culled due to chronic progressive wasting. An additional 228 ewes with low body condition score (BCS, but not targeted for culling, were tested with ELISA to estimate the proportion of OJD in ewes in the lower 5% BCS of the flock. Calculations were done separately for fine-wool and other breeds. Based on the data, mortality due to OJD, its associated cost and the benefit-cost of vaccination were evaluated for a hypothetical farm with 2000 ewes by stochastic simulation. Total ewe mortality was similar in fine-wool and other breeds, but the estimated mortality due to OJD was 2.7 times as high in fine-wool (median 1.8%, interquartile range IQR 1.2–2.7% than other breeds (median 0.69%, IQR 0.3–1.2%, but with large variation between farms. ELISA results demonstrated fine-wool sheep had a higher seroprevalence than other breeds (39%, 95% CI 18–61% vs. 9%, 95% CI 0–22%. Stochastic modelling indicated that the average annual cost of mortality due to OJD in a flock of 2000 ewes was NZD 13,100 (IQR 8900–18,600 in fine-wool and NZD 4300 (IQR 2200–7600 in other breeds. Vaccinating replacement lambs against OJD may be cost-effective in most flocks when the pre-vaccination annual ewe mortality due to OJD is >1%. To make the best-informed decision about vaccination it is therefore essential for farmers

  18. Clinical update on benefit versus risks of oral paracetamol alone or with codeine: still a good option?

    Science.gov (United States)

    Kress, Hans Georg; Untersteiner, Gerald

    2017-02-01

    After decades of worldwide use of paracetamol/acetaminophen as a popular and apparently safe prescription and over-the-counter medicine, the future role of this poorly understood analgesic has been seriously questioned by recent concerns about prenatal, cardiovascular (CV) and hepatic safety, and also about its analgesic efficacy. At the same time the usefulness of codeine in combination products has come under debate. Based on a PubMed database literature search on the terms efficacy, safety, paracetamol, acetaminophen, codeine and their combinations up to and including June 2016, this clinical update reviews the current evidence of the benefit and risks of oral paracetamol alone and with codeine for mild-to-moderate pain in adults, and compares the respective efficacy and safety profiles with those of nonsteroidal anti-inflammatory drugs (NSAIDs). Whereas there is a clear strong association of NSAID use and gastrointestinal (GI) and CV morbidity and mortality, evidence for paracetamol with and without codeine supports the recommended use even in most vulnerable individuals, such as the elderly, pregnant women, alcoholics, and compromised GI and CV patients. The controversies and widespread misconceptions about the complex hepatic metabolism and potential hepatotoxicity have been corrected by recent reviews, and paracetamol remains the first-line nonopioid analgesic in patients with liver diseases if notes of caution are applied. Due to its safety and tolerability profile paracetamol remained a first-line treatment in many international guidelines. Alone and with codeine it is a safe and effective option in adults, whilst NSAIDs are obviously less safe as alternatives, given the risk of potentially fatal GI and CV adverse effects.

  19. Benefits of a clinical data warehouse with data mining tools to collect data for a radiotherapy trial.

    Science.gov (United States)

    Roelofs, Erik; Persoon, Lucas; Nijsten, Sebastiaan; Wiessler, Wolfgang; Dekker, André; Lambin, Philippe

    2013-07-01

    Collecting trial data in a medical environment is at present mostly performed manually and therefore time-consuming, prone to errors and often incomplete with the complex data considered. Faster and more accurate methods are needed to improve the data quality and to shorten data collection times where information is often scattered over multiple data sources. The purpose of this study is to investigate the possible benefit of modern data warehouse technology in the radiation oncology field. In this study, a Computer Aided Theragnostics (CAT) data warehouse combined with automated tools for feature extraction was benchmarked against the regular manual data-collection processes. Two sets of clinical parameters were compiled for non-small cell lung cancer (NSCLC) and rectal cancer, using 27 patients per disease. Data collection times and inconsistencies were compared between the manual and the automated extraction method. The average time per case to collect the NSCLC data manually was 10.4 ± 2.1 min and 4.3 ± 1.1 min when using the automated method (pdata collected for NSCLC and 5.3% for rectal cancer, there was a discrepancy between the manual and automated method. Aggregating multiple data sources in a data warehouse combined with tools for extraction of relevant parameters is beneficial for data collection times and offers the ability to improve data quality. The initial investments in digitizing the data are expected to be compensated due to the flexibility of the data analysis. Furthermore, successive investigations can easily select trial candidates and extract new parameters from the existing databases. Copyright © 2012 Elsevier Ireland Ltd. All rights reserved.

  20. The Healthy Start Renal Clinic: Benefits of Tracking and Early Intervention in Pre-End Stage Renal Disease Patients

    Science.gov (United States)

    Self, Ida; Lindberg, Jill; Filangeri, Judith; Anderson, Shannon; Szerlip, Marjorie; Best, Julie; Sadler, Rebecca; Savoie, Judy; Jackson, Dina; James, Carla; Husserl, Fred; Copely, J. Brian

    1999-01-01

    Several studies have demonstrated a strong association between the benefits of pre-end stage renal disease (ESRD) education and decreased length of hospital stay (LOS) and hospital charges, delay of renal replacement therapy (RRT), and a smooth transition to RRT. The Ochsner Healthy Start Renal Clinic (HSRC) is a multidisciplinary early education and tracking program for pre-ESRD patients and their families. We identified and educated pre-ESRD patients about kidney disease, allowing them to discuss and make informed decisions about their treatment and be better prepared to cope with the transition to RRT and the changes in their lives resulting from kidney failure. HSRC patients demonstrated a significant decrease in length of hospital stay (p = 0.05), a trend towards decreased hospital episodes and charges, decreased use of temporary venous access, and a smooth transition to RRT. The control group was made up of patients who had either refused the structured education or had been referred to HSRC late and received only conventional instruction by a social worker at the point where dialysis was imminent. We compared the number of episodes of hospitalization, LOS, and overall hospital charges for the period immediately surrounding initiation of chronic dialysis (2 months before and 1 month following onset) of all 36 patients who began chronic hemodialysis in our facility between November 1997 and November 1998. HSRC patients had LOS half as long (p=0.05), fewer hospital episodes, and hospital charges of $5,000 less per patient than the non-HSRC group. Initial data strongly suggest that early education and intervention through the coordination of a multidisciplinary team maximize the continuity of patient care. PMID:21845139

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

    Energy Technology Data Exchange (ETDEWEB)

    Tabibian, Art A., E-mail: art.tabibian@gmail.com [University of Texas School of Allied Health-Medical Dosimetry, Houston, TX (United States); Powers, Adam; Dolormente, Keith; Oommen, Sneha; Tiwari, Akhil [University of Texas School of Allied Health-Medical Dosimetry, Houston, TX (United States); Palmer, Matt [MD Anderson Department of Radiation Oncology, Houston, TX (United States); Zhu, Xiaorong R.; Li, Heng; Sahoo, Narayan; Wisdom, Paul [MD Anderson Department of Radiation Physics, Houston, TX (United States); Velasco, Kyle [Radiation Oncology Resources, Goshen, IN (United States); Erhart, Kevin; Stanley, Henry [Decimal, Inc, Sanford, FL (United States); Nguyen, Bao-Ngoc T. [MD Anderson Department of Radiation Oncology, Houston, TX (United States)

    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.

  2. Review of existing experimental approaches for the clinical evaluation of the benefits of plant food supplements on cardiovascular function.

    Science.gov (United States)

    Meoni, Paolo; Restani, Patrizia; Mancama, Dalu T

    2013-06-01

    We conducted a survey of the National Centre for Biotechnology Information (NCBI) PubMed database to identify methods most commonly used for the evaluation of the effect of plant food supplements on the cardiovascular system and their relevance to the regulatory status of these products. Particularly, our search strategy was aimed at the selection of studies concerning the clinical evaluation of the beneficial effects of the most commonly studied plant food supplements acting on the cardiovascular system. Following the screening of 3839 papers for inclusion criteria, 48 published reports were retained for this review. Most studies included in this review used a double blind controlled design, and evaluated the effect of plant food supplements on individuals affected by a disease of the cardiovascular system. The majority of the studies were found to be of low methodological quality on the Jadad scale, mainly because of inadequate reporting of adverse events and of patient withdrawals. In comparison, measures used for the evaluation of benefits included mostly cardiovascular risk factors as recommended in international guidelines and in accordance with principles laid down for the evaluation of health claims in food. The risk factors most frequently evaluated belonged to the category of "lipid function and levels", "heart function" and "blood pressure". For the absolute majority of the studies, the study period did not exceed one month. This review highlights critical factors to be considered in the design of studies evaluating the health effects of plant food supplements on the cardiovascular system. Between others, the inclusion of healthy individuals, better reporting and description of the characteristics of the product used could improve the quality and relevance of these studies.

  3. Clinical benefits and oncologic equivalence of self-expandable metallic stent insertion for right-sided malignant colonic obstruction.

    Science.gov (United States)

    Ji, Woong Bae; Kwak, Jung Myun; Kang, Dong Woo; Kwak, Han Deok; Um, Jun Won; Lee, Sun-Il; Min, Byung-Wook; Sung, Nak Song; Kim, Jin; Kim, Seon Hahn

    2017-01-01

    The efficacy of stenting for right-sided malignant colonic obstruction is unknown. This study aimed to evaluate the safety, feasibility, and clinical benefits of self-expandable metallic stent insertion for right-sided malignant colonic obstruction. Clinical data from patients who underwent right hemicolectomy for right colon cancer from January 2006 to July 2014 at three Korea University hospitals were retrospectively reviewed. A total of 39 patients who developed malignant obstruction in the right-sided colon were identified, and their data were analyzed. Stent insertion was attempted in 16 patients, and initial technical success was achieved in 14 patients (87.5 %). No stent-related immediate complications were reported. Complete relief from obstruction was achieved in all 14 patients. Twenty-five patients, including two patients who failed stenting, underwent emergency surgery. In the stent group, 93 % (13/14) of patients underwent elective laparoscopic surgery, and only one surgery was converted to an open procedure. All patients in the emergency group underwent emergency surgery within 24 h of admission. In the emergency group, only 12 % (3/25) of patients underwent laparoscopic surgery, with one surgery converted to an open procedure. All patients in both groups underwent either laparoscopy-assisted or open right/extended right hemicolectomy with primary anastomoses as the first operation. The operative times, retrieved lymph nodes, and pathologic stage did not differ between the two groups. Postoperative hospital stay (9.4 ± 3.4 days in the stent group vs. 12.4 ± 5.9 in the emergency group, p = 0.089) and time to resume oral food intake (3.2 ± 2.1 days in the stent group vs. 5.7 ± 3.4 in the emergency group, p = 0.019) were shorter in the stent group. And there were no significant differences in disease-free survival and overall survival between the two groups. Stent insertion appears to be safe and feasible in patients with right

  4. Estimating the clinical and economic benefit associated with incremental improvements in sustained virologic response in chronic hepatitis C.

    Directory of Open Access Journals (Sweden)

    Phil McEwan

    Full Text Available Hepatitis C virus (HCV infection is one of the principle causes of chronic liver disease. Successful treatment significantly decreases the risk of hepatic morbidity and mortality. Current standard of care achieves sustained virologic response (SVR rates of 40-80%; however, the HCV therapy landscape is rapidly evolving. The objective of this study was to quantify the clinical and economic benefit associated with increasing levels of SVR.A published Markov model (MONARCH that simulates the natural history of hepatitis C over a lifetime horizon was used. Discounted and non-discounted life-years (LYs, quality-adjusted life-years (QALYs and cost of complication management were estimated for various plausible SVR rates. To demonstrate the robustness of projections obtained, the model was validated to ten UK-specific HCV studies.QALY estimates ranged from 18.0 years for those treated successfully in fibrosis stage F0 to 7.5 years (discounted for patients in fibrosis stage F4 who remain untreated. Predicted QALY gains per 10% improvement in SVR ranged from 0.23 (F0 to 0.64 (F4 and 0.58 (F0 to 1.35 (F4 in 40 year old patients (discounted and non-discounted results respectively. In those aged 40, projected discounted HCV-related costs are minimised with successful treatment in F0/F1 (at approximately £ 300, increasing to £ 49,300 in F4 patients who remain untreated. Validation of the model to published UK cost-effectiveness studies produce R2 goodness of fit statistics of 0.988, 0.978 and of 0.973 for total costs, QALYs and incremental cost effectiveness ratios, respectively.Projecting the long-term clinical and economic consequences associated with chronic hepatitis C is a necessary requirement for the evaluation of new treatments. The principle analysis demonstrates the significant impact on expected costs, LYs and QALYs associated with increasing SVR. A validation analysis demonstrated the robustness of the results reported.

  5. Clinical benefit of systemic treatment in patients with advanced pancreatic and gastro-intestinal neuroendocrine tumours according to ESMO-MCBS and ASCO framework.

    Science.gov (United States)

    de Hosson, L D; Veenendaal, L M van; Schuller, Y; Zandee, W T; de Herder, W W; Tesselaar, M E T; Klümpen, H J; Walenkamp, A M E

    2017-09-26

    BackgroundAssessment of clinical benefit of systemic treatments of rare diseases including gastroenteropancreatic neuroendocrine tumors (GEP-NET) is challenging. Recently several tools have been developed to grade clinical benefit of cancer drugs. European Society for Medical Oncology (ESMO) has developed the ESMO Magnitude of Clinical Benefit Scale (ESMO-MCBS). The American Society of Clinical Oncology (ASCO) developed and revised the ASCO framework consisting of the Net Health Benefit (NHB) score juxtaposed against the costs of the treatment. In this review we graded systemic treatments for GEP-NET patients with both frameworks.MethodsThe electronic databases (PubMed, Embase) were searched for papers reporting comparative trials, conducted in adult GEP-NET patients in the English language. Papers were assessed according to the ESMO-MCBS and the NHB part of the ASCO revised Framework (NHB-ASCO-F) by 4 independent assessors, discrepancies were discussed.ResultsThe search yielded 32 trials of which 6 trials were eligible for grading with the ESMO-MCBS resulting in scores of 2 or 3. Eight trials were eligible for grading with the NHB-ASCO-F; resulting in scores between 37.6 and 57.4. Trials that were not primary assessable by the tools were analysed separately. Consensus between assessors was reached in 68% of trials with the ESMO-MCBS and in 23% of trials with the NHB-ASCO-F.ConclusionThe currently used systemic treatments for GEP-NET patients had low scores according to the NHB-ASCO-F and none could be graded as meaningful clinical beneficial according to the ESMO-MCBS. Despite the low incidence, the heterogeneous patient population and relatively long natural course of NET, future studies on new treatment modalities should aim for high clinical benefit outcomes. © The Author 2017. Published by Oxford University Press on behalf of the European Society for Medical Oncology. All rights reserved. For permissions, please email: journals.permissions@oup.com.

  6. Seeking a progressive relationship for learning: A theoretical scheme about the continuity of the student-educator relationship in clinical nursing education.

    Science.gov (United States)

    Yaghoubinia, Fariba; Heydari, Abbas; Latifnejad Roudsari, Robab

    2014-01-01

    The student-educator relationship is an educational tool in nursing education and has long-lasting influence on the professional development of nursing students. Currently, this relationship in clinical settings is different from that in the past due to a paradigm shift in nursing education and its emphasis on the centrality of the relationship. The purpose of this grounded theory study was to explore the continuity of the student-educator relationship in the Iranian context of clinical nursing education. Ten bachelor nursing students and 10 clinical educators at Mashhad University of Medical Sciences, Iran, were selected through purposive and theoretical sampling. The data were collected through semi-structured interviews and participant observation. Interviews were transcribed verbatim, and data analysis was done through open, axial, and selective coding, using MAXQDA ver. 2007 qualitative data analysis software. The core category emerging from the data analysis was "seeking a progressive relationship for learning". Other major categories linked to and embraced within this core category were: "creating emotional connection", "trying to continue the relationship chain", and "adapting the behaviors". The findings indicated that in the Iranian sociocultural context, students and educators gain some action/interaction strategies for continuity of their relationship. It is obvious that the role of the nursing clinical educators and their relationship skills are critical in the relationship continuity of clinical settings. © 2013 The Authors. Japan Journal of Nursing Science © 2013 Japan Academy of Nursing Science.

  7. The likelihood of reaching minimum clinically important difference and substantial clinical benefit at 2 years following a 3-column osteotomy: analysis of 140 patients.

    Science.gov (United States)

    Fakurnejad, Shayan; Scheer, Justin K; Lafage, Virginie; Smith, Justin S; Deviren, Vedat; Hostin, Richard; Mundis, Gregory M; Burton, Douglas C; Klineberg, Eric; Gupta, Munish; Kebaish, Khaled; Shaffrey, Christopher I; Bess, Shay; Schwab, Frank; Ames, Christopher P

    2015-09-01

    Three-column osteotomies (3COs) are technically challenging techniques for correcting severe rigid spinal deformities. The impact of these interventions on outcomes reaching minimum clinically important difference (MCID) or substantial clinical benefit (SCB) is unclear. The objective of this study was to determine the rates of MCID and SCB in standard health-related quality of life (HRQOL) measures after 3COs in patients with adult spinal deformity (ASD). The impacts of location of the uppermost instrumented vertebra (UIV) on clinical outcomes and of maintenance on sagittal correction at 2 years postoperatively were also examined. The authors conducted a retrospective multicenter analysis of the records from adult patients who underwent 3CO with complete 2-year radiographic and clinical follow-ups. Cases were categorized according to established radiographic thresholds for pelvic tilt (> 22°), sagittal vertical axis (> 4.7 cm), and the mismatch between pelvic incidence and lumbar lordosis (> 11°). The cases were also analyzed on the basis of a UIV in the upper thoracic (T1-6) or thoracolumbar (T9-L1) region. Patient-reported outcome measures evaluated preoperatively and 2 years postoperatively included Oswestry Disability Index (ODI) scores, the Physical Component Summary and Mental Component Summary (MCS) scores of the 36-Item Short Form Health Survey, and Scoliosis Research Society-22 questionnaire (SRS-22) scores. The percentages of patients whose outcomes for these measures met MCID and SCB were compared among the groups. Data from 140 patients (101 women and 39 men) were included in the analysis; the average patient age was 57.3 ± 12.4 years (range 20-82 years). Of these patients, 94 had undergone only pedicle subtraction osteotomy (PSO) and 42 only vertebral column resection (VCR); 113 patients had a UIV in the upper thoracic (n = 63) orthoracolumbar region (n = 50). On average, 2 years postoperatively the patients had significantly improved in all HRQOL

  8. Medicaid Benefits

    Science.gov (United States)

    ... Policy and Program Topics Alternative Benefit Plan Coverage Autism Services Behavioral Health Services Dental Care Early and Periodic Screening, Diagnostic, and Treatment Hospice Benefits List of Medicaid Benefits ...

  9. Right brain, left brain in depressive disorders: Clinical and theoretical implications of behavioral, electrophysiological and neuroimaging findings.

    Science.gov (United States)

    Bruder, Gerard E; Stewart, Jonathan W; McGrath, Patrick J

    2017-07-01

    The right and left side of the brain are asymmetric in anatomy and function. We review electrophysiological (EEG and event-related potential), behavioral (dichotic and visual perceptual asymmetry), and neuroimaging (PET, MRI, NIRS) evidence of right-left asymmetry in depressive disorders. Recent electrophysiological and fMRI studies of emotional processing have provided new evidence of altered laterality in depressive disorders. EEG alpha asymmetry and neuroimaging findings at rest and during cognitive or emotional tasks are consistent with reduced left prefrontal activity in depressed patients, which may impair downregulation of amygdala response to negative emotional information. Dichotic listening and visual hemifield findings for non-verbal or emotional processing have revealed abnormal perceptual asymmetry in depressive disorders, and electrophysiological findings have shown reduced right-lateralized responsivity to emotional stimuli in occipitotemporal or parietotemporal cortex. We discuss models of neural networks underlying these alterations. Of clinical relevance, individual differences among depressed patients on measures of right-left brain function are related to diagnostic subtype of depression, comorbidity with anxiety disorders, and clinical response to antidepressants or cognitive behavioral therapy. Copyright © 2017 Elsevier Ltd. All rights reserved.

  10. A net clinical benefit analysis of warfarin and aspirin on stroke in patients with atrial fibrillation: a nested case–control study

    Directory of Open Access Journals (Sweden)

    Azoulay Laurent

    2012-06-01

    Full Text Available Abstract Background As the management of patients treated with anticoagulants and antiplatelet drugs entails balancing coagulation levels, we evaluated the net clinical benefit of warfarin and aspirin on stroke in a large cohort of patients with atrial fibrillation (AF. Methods A population-based cohort study of all patients at least 18 years of age with a first-ever diagnosis of chronic AF during the period 1993–2008 was conducted within the United Kingdom General Practice Research Database. A nested case–control analysis was conducted to estimate the risk of ischemic stroke and intracranial hemorrhage associated with the use of warfarin and aspirin. Cases were matched up to 10 controls on age, sex, and date of cohort entry. The adjusted net clinical benefit of warfarin and aspirin (expressed as the number of strokes prevented per 100 persons per year was calculated by subtracting the ischemic stroke rate (prevented by therapy from the intracranial hemorrhage (ICH rate (increased by therapy. Results The cohort included 70,766 patients newly-diagnosed with chronic AF, of whom 5519 experienced an ischemic stroke and 689 an ICH during follow-up. The adjusted net clinical benefit of warfarin was 0.59 (95% CI: 0.45, 0.73. However, the benefit was not seen for patients below (0.08, 95%: -0.38, 0.54 and above (−0.49, 95% CI: -1.13, 0.15 therapeutic range. The net clinical benefit of warfarin, apparent after 3 months of continuous use, increased as a function of CHADS2 score. The net clinical benefit was not significant with aspirin (−0.07, 95% CI: -0.22, 0.08, though it was seen in certain subgroups. Conclusions Warfarin provides a net clinical benefit in patients with atrial fibrillation, which is maintained with longer duration of use, particularly when used within therapeutic range. A similar net effect is not as clear with aspirin.

  11. Benefit from non-linear frequency compression hearing aids in a clinical setting: the effects of duration of experience and severity of high-frequency hearing loss.

    Science.gov (United States)

    Hopkins, Kathryn; Khanom, Mumtaz; Dickinson, Ann-Marie; Munro, Kevin J

    2014-04-01

    To determine whether non-linear frequency compression (NLFC) is effective for hearing-impaired adults in a clinical setting. To determine whether benefit from NLFC is related to duration of NLFC experience or severity of high-frequency hearing loss. Participants were fitted with Phonak frequency compression hearing aids as part of their standard clinical care, using the manufacturer's default fitting settings. Participants had been using NLFC for between 1 and 121 weeks at the time of testing. Speech recognition thresholds in noise and consonant recognition in quiet were measured with and without NLFC enabled. Forty-six experienced adult hearing-aid users. Consonant recognition in quiet, but not speech recognition in noise was significantly better with NLFC enabled. There was no significant correlation between duration of frequency compression experience and benefit. Benefit for consonant recognition was negatively correlated with mean audiometric thresholds from 2-6 kHz. NLFC was beneficial for consonant recognition but not speech recognition in noise. There was no evidence to support the idea that a long period of acclimatization is necessary to gain full benefit. The relation between benefit and high-frequency thresholds might be explained by the poor audibility of compressed information for some listeners with severe loss.

  12. The benefit of nonoperative treatment for adult spinal deformity: identifying predictors for reaching a minimal clinically important difference.

    Science.gov (United States)

    Liu, Shian; Diebo, Bassel G; Henry, Jensen K; Smith, Justin S; Hostin, Richard; Cunningham, Matthew E; Mundis, Gregory; Ames, Christopher P; Burton, Douglas; Bess, Shay; Akbarnia, Behrooz; Hart, Robert; Passias, Peter G; Schwab, Frank J; Lafage, Virginie

    2016-02-01

    Adult spinal deformity (ASD) patients may gain minimal clinically important difference (MCID) in one or more of the health-related quality-of-life instruments without surgical intervention. The present study identifies the baseline characteristics of this subset of nonoperative patients and proposes predictors of those most likely to benefit. The study aims to determine the factors that affect likelihood of nonoperative patients to reach MCID. This is a retrospective review of a prospective, multicenter database. The study includes nonoperative ASD patients. Health-related quality-of-life measures, including the Scoliosis Research Society (SRS)-22 questionnaire, were used. The study used a multicenter database of 215 nonoperative patients with ASD and with minimum 2-year follow-up. Using a multivariate analysis, two groups were compared to identify possible predictors: those who reached MCID in the SRS pain or activity (N=86) at 2 years and those who did not reach MCID (N=129). A subgroup multivariate analysis of patients with a deficit (potential improvement) in both SRS pain and activity (N=84) was performed. Data collection was supported by a grant from DePuy for the International Spine Study Group Foundation. At baseline, the nonoperative patients who reached MCID had a significantly lower SRS pain score (3.0 vs. 3.6), smaller thoracolumbar Cobb (TL Cobb) angle (29.6° vs. 36.5°; 87 patients with SRS-Schwab classification of lumbar or double), lower sacral slope (33.1° vs. 36.4°), and less lumbar lordosis (46.5° vs. 52.8°) (all pMCID. The pelvic incidence minus lumbar lordosis (PI-LL) was significant on univariate analysis but not on multivariate analysis (7.5° vs. 2.6°; p=.14). In the subset of severely disabled patients, worse vertebral obliquity was a predictor for not achieving MCID (pMCID in SRS activity or pain had a lower baseline SRS pain score and less coronal deformity in the TL region. Greater baseline pain offers significant room for

  13. Pharmacokinetics and adverse effects of doxycycline in the treatment of Ehrlichiosis: theoretical foundations for clinical trials in canines

    Directory of Open Access Journals (Sweden)

    Santiago Monsalve B

    2017-05-01

    Full Text Available Ehrlichia canis is the causative bacterium of canine monocytic ehrlichiosis (CME, a disease of global importance in veterinary and human medicine. Several studies have addressed the therapeutic efficacy of tetracycline hydrochloride and doxycycline hyclate (HD for the treatment of CME, however the results are still controversial. Doxycycline is the treatment of choice for canine monocytic ehrlichiosis (CME, a well characterized disease that can serve as a model for research in diseases of the Rickettsial order and tick-borne zoonoses. Although the pharmacokinetics and efficacy of the treatment in the acute and subclinical CME phases have been known for decades, some results also indicate that Ehrlichia canis may persist in clinically normal dogs, even after an extensive treatment regimen. The purpose of this review is to (major delve into/further investigate the pharmacokinetics and side effects of doxycycline in the treatment of canine ehrlichiosis.

  14. Reply to the letter to the editor 'The ESMO Magnitude of Clinical Benefit Scaling Tool : from theory to practice' by Hartmann and the letter 'Comment on ESMO Magnitude of Clinical Benefit Scale' by Muhonen et al.

    NARCIS (Netherlands)

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

    The ESMO-MCBS authors justify the use of the lower 95% HR confidence interval in threshold evaluation for benefit (and explain why the point estimate would be inappropriate) and discuss the validity of the scale with regard to Health Technology Assessment processes, EUnetHTA and national HTA bodies.

  15. Behavioral and emotional adverse events of drugs frequently used in the treatment of bipolar disorders: clinical and theoretical implications.

    Science.gov (United States)

    Szmulewicz, Alejandro; Samamé, Cecilia; Caravotta, Pablo; Martino, Diego J; Igoa, Ana; Hidalgo-Mazzei, Diego; Colom, Francesc; Strejilevich, Sergio A

    2016-12-01

    Behavioral and emotional adverse events induced by drugs commonly prescribed to patients with bipolar disorders are of paramount importance to clinical practice and research. However, no reviews on the topic have been published so far. An extensive search was performed. Reports were reviewed if they described behavioral side effects related to pharmacological treatments for bipolar disorders in healthy subjects or patients with different neuropsychiatric disorders. For this review, lithium, antipsychotics, anticonvulsants and selective serotonin reuptake inhibitors were included. Apathy or emotional blunting, diminished sexual desire, and inability to cry were reported to be associated with exposure to selective serotonin reuptake inhibitors. Neuroleptic-induced deficit syndrome/emotional detachment and obsessive-compulsive symptomatology and decision-making modifications. A lithium-related amotivational syndrome was also reported in the literature. Furthermore, hypersexuality and obsessive-compulsive symptoms have been noted in subjects treated with lamotrigine. Primary studies on drug-related adverse events are scant so far and most of the data currently available derive from case reports. Moreover, most of the evidence reviewed is based on studies performed on healthy subjects and patients with neuropsychiatric conditions other than bipolar disorders. There is a remarkable dearth of data on behavioral adverse events of pharmacological treatment for bipolar disorders. However, the pieces of evidence available at present, though scant and scattered, suggest that different behavioral adverse events may be related to pharmacological treatment for these disorders. The implications of these findings for research and management of patients with mood disorders are discussed.

  16. Four-hour delayed memory recall for stories: Theoretical and clinical implications of measuring accelerated long-term forgetting.

    Science.gov (United States)

    Ladowsky-Brooks, Ricki L

    2016-01-01

    It has been noted that clinical neuropsychological assessment is "blind" to certain abnormalities of consolidation that occur beyond standard 30-min delay intervals. For example, normal forgetting at 30-min delays has been followed by enhanced forgetting at longer delays in temporal-lobe epilepsy, termed accelerated long-term forgetting (ALF). To evaluate whether ALF could be identified in the neuropsychological assessment of a small sample of examinees with head injuries or other neurological diagnoses (n = 42), a 4-hr delayed recall condition was added to the Logical Memory subtest of the Wechsler Memory Scale-Third Edition. A small percentage of examinees (5/42 or 11%), despite exhibiting unimpaired story recall immediately and after 30-min delays, showed increased forgetting when compared with the average retention of stories (M = 0.83, SD = 0.17) after a 4-hr delay. Three of these 5 examinees also had impaired scores on 20-min delayed recall of the California Verbal Learning Test-Second Edition (CVLT-II) and would have been identified as having memory impairment without an extended, 4-hr delayed recall. In fact, the highest correlation among memory indexes was between 4-hr delayed recall of stories and delayed recall of the CVLT-II word list (r = .59, p < .0001), suggesting different consolidation rates for relational and nonrelational material.

  17. Defining biotypes for depression and anxiety based on large-scale circuit dysfunction: a theoretical review of the evidence and future directions for clinical translation.

    Science.gov (United States)

    Williams, Leanne M

    2017-01-01

    Complex emotional, cognitive and self-reflective functions rely on the activation and connectivity of large-scale neural circuits. These circuits offer a relevant scale of focus for conceptualizing a taxonomy for depression and anxiety based on specific profiles (or biotypes) of neural circuit dysfunction. Here, the theoretical review first outlines the current consensus as to what constitutes the organization of large-scale circuits in the human brain identified using parcellation and meta-analysis. The focus is on neural circuits implicated in resting reflection (default mode), detection of "salience," affective processing ("threat" and "reward"), "attention," and "cognitive control." Next, the current evidence regarding which type of dysfunctions in these circuits characterize depression and anxiety disorders is reviewed, with an emphasis on published meta-analyses and reviews of circuit dysfunctions that have been identified in at least two well-powered case:control studies. Grounded in the review of these topics, a conceptual framework is proposed for considering neural circuit-defined "biotypes." In this framework, biotypes are defined by profiles of extent of dysfunction on each large-scale circuit. The clinical implications of a biotype approach for guiding classification and treatment of depression and anxiety is considered. Future research directions will develop the validity and clinical utility of a neural circuit biotype model that spans diagnostic categories and helps to translate neuroscience into clinical practice in the real world. © 2016 Wiley Periodicals, Inc.

  18. Net clinical benefit of warfarin in individuals with atrial fibrillation across stroke risk and across primary and secondary care.

    Science.gov (United States)

    Allan, Victoria; Banerjee, Amitava; Shah, Anoop Dinesh; Patel, Riyaz; Denaxas, Spiros; Casas, Juan-Pablo; Hemingway, Harry

    2017-02-01

    To investigate net clinical benefit (NCB) of warfarin in individuals with atrial fibrillation (AF) across stroke risk and across primary and secondary care. We conducted a linked electronic health record cohort study of 70 206 individuals with initial record of diagnosis of AF in primary (n=29 568) or secondary care (n=40 638) in England (1998-2010). We defined stroke risk according to the CHA2DS2-VASc score, and followed individuals over a median 2.2 years for 7005 ischaemic strokes (IS) and for 906 haemorrhagic strokes (HS). We calculated incidence rates (IRs) and 95% CIs per 100 person-years (PYs) (IR (95% CI)/100 PY) of IS and HS, with and without use of warfarin, and the NCB (ie, number of IS avoided) per 100 PYs of warfarin use (NCB (95% CI)/100 PY). Compared with individuals with initial record of diagnosis in secondary care, those in primary care had lower scores of IS risk (CHA2DS2-VASc≤2: 30.8% vs 20.6%), and lower overall incidence of IS (IR (95% CI)/100 PY: 2.3 (2.2 to 2.4) vs 4.3 (4.2 to 4.4), p value=0.00); however among individuals with CHA2DS2-VASc=0, 1 or 2 there were no differences in IS rate between those with initial record of diagnosis in primary care or secondary care (IR (95% CI)/100 PY: 0.2 (0.1 to 0.3) vs 0.3 (0.2 to 0.5), p value=0.16), (IR (95% CI)/100 PY: 0.6 (0.4 to 0.7) vs 0.7 (0.6 to 0.9), p value=0.08) and (IR (95% CI)/100 PY: 1.1 (1.00 to 1.3) vs 1.4 (1.2 to 1.6), p value=0.05), respectively. For CHA2DS2-VASc=0, 1 and 2, IRs of IS with versus without warfarin were (IR (95% CI)/100 PY: 0.4 (0.2 to 0.8) vs 0.2 (0.1 to 0.3), p value=0.16), (IR (95% CI)/100 PY: 0.4 (0.3 to 0.7) vs 0.7 (0.6 to 0.8), p value=0.03) and (IR (95% CI)/100 PY: 0.8 (0.7 to 1.0) vs 1.4 (1.3 to 1.6), p value=0.00), respectively. We found a significant positive NCB of warfarin from CHA2DS2-VASc≥2 in men (NCB (95% CI)/100 PY: 0.5 (0.1 to 0.9)) and from CHA2DS2-VASc≥3 in women (NCB (95% CI)/100 PY: 1.5 (1.1 to 1.9)). CHA2DS2-VASc

  19. Longer term clinical and economic benefits of offering acupuncture care to patients with chronic low back pain.

    Science.gov (United States)

    Thomas, K J; MacPherson, H; Ratcliffe, J; Thorpe, L; Brazier, J; Campbell, M; Fitter, M; Roman, M; Walters, S; Nicholl, J P

    2005-08-01

    To test whether patients with persistent non-specific low back pain, when offered access to traditional acupuncture care alongside conventional primary care, gained more long-term relief from pain than those offered conventional care only, for equal or less cost. Safety and acceptability of acupuncture care to patients, and the heterogeneity of outcomes were also tested. A pragmatic, two parallel group, randomised controlled trial. Patients in the experimental arm were offered the option of referral to the acupuncture service comprising six acupuncturists. The control group received usual care from their general practitioner (GP). Eligible patients were randomised in a ratio of 2:1 to the offer of acupuncture to allow between-acupuncturist effects to be tested. Three non-NHS acupuncture clinics, with referrals from 39 GPs working in 16 practices in York, UK. Patients aged 18-65 years with non-specific low back pain of 4-52 weeks' duration, assessed as suitable for primary care management by their general practitioner. The trial protocol allowed up to ten individualised acupuncture treatments per patient. The acupuncturist determined the content and the number of treatments according to patient need. The Short Form 36 (SF-36) Bodily Pain dimension (range 0-100 points), assessed at baseline, and 3, 12 and 24 months. The study was powered to detect a 10-point difference between groups at 12 months post-randomisation. Cost--utility analysis was conducted at 24 months using the EuroQoL 5 Dimensions (EQ-5D) and a preference-based single index measure derived from the SF-36 (SF-6D). Secondary outcomes included the McGill Present Pain Index (PPI), Oswestry Pain Disability Index (ODI), all other SF-36 dimensions, medication use, pain-free months in the past year, worry about back pain, satisfaction with care received, and safety and acceptability of acupuncture care. A total of 159 patients were in the 'acupuncture offer' arm and 80 in the 'usual care' arm. All 159 patients

  20. Clinical Benefits of Stem Cells for Chronic Symptomatic Systolic Heart Failure: A Systematic Review of the Existing Data and Ongoing Trials.

    Science.gov (United States)

    Poulin, Marie-France; Deka, Anjan; Mohamedali, Burhan; Schaer, Gary L

    2016-11-01

    The benefits of stem cell therapy for patients with chronic symptomatic systolic heart failure due to ischemic and nonischemic cardiomyopathy (ICM and NICM, respectively) are unclear. We performed a systematic review of major published and ongoing trials of stem cell therapy for systolic heart failure and compared measured clinical outcomes for both types of cardiomyopathy. The majority of the 29 published studies demonstrated clinical benefits of autologous bone marrow-derived mesenchymal stem cells (BM-MSCs). Left ventricular ejection fraction (LVEF) was improved in the majority of trials after therapy. Cell delivery combined with coronary artery bypass grafting was associated with the greatest improvement in LVEF. Left ventricular end-systolic volume (or diameter), New York Heart Association functional classification, quality of life, and exercise capacity were also improved in most studies after cell therapy. Most ICM trials demonstrated a significant improvement in perfusion defects, infarct size, and myocardial viability. Several larger clinical trials that are in progress employ alternative delivery modes, cell types, and longer follow-up periods. Stem cells are a promising therapeutic modality for patients with heart failure due to ICM or NICM. More data are required from larger blinded trials to determine which combination of cell type and delivery mode will yield the most benefit with avoidance of harm in these patient populations.

  1. Are there long-term benefits in following stable heart failure patients in a heart failure clinic?

    DEFF Research Database (Denmark)

    Leetmaa, Tina; Villadsen, Henrik; Mikkelsen, Kirsten

    2008-01-01

    Objectives and Design. This study describes the long-term outcome of 163 patients with stable mild to moderate heart failure (NYHA II-III), who already were enrolled in a heart failure clinic and now were randomized to continued follow-up in the heart failure (HF) clinic or else to usual care (UC...

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

    Science.gov (United States)

    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

    2011-10-04

    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.

  3. Cost-benefit assessment of using electronic health records data for clinical research versus current practices: Contribution of the Electronic Health Records for Clinical Research (EHR4CR) European Project.

    Science.gov (United States)

    Beresniak, Ariel; Schmidt, Andreas; Proeve, Johann; Bolanos, Elena; Patel, Neelam; Ammour, Nadir; Sundgren, Mats; Ericson, Mats; Karakoyun, Töresin; Coorevits, Pascal; Kalra, Dipak; De Moor, Georges; Dupont, Danielle

    2016-01-01

    The widespread adoption of electronic health records (EHR) provides a new opportunity to improve the efficiency of clinical research. The European EHR4CR (Electronic Health Records for Clinical Research) 4-year project has developed an innovative technological platform to enable the re-use of EHR data for clinical research. The objective of this cost-benefit assessment (CBA) is to assess the value of EHR4CR solutions compared to current practices, from the perspective of sponsors of clinical trials. A CBA model was developed using an advanced modeling approach. The costs of performing three clinical research scenarios (S) applied to a hypothetical Phase II or III oncology clinical trial workflow (reference case) were estimated under current and EHR4CR conditions, namely protocol feasibility assessment (S1), patient identification for recruitment (S2), and clinical study execution (S3). The potential benefits were calculated considering that the estimated reduction in actual person-time and costs for performing EHR4CR S1, S2, and S3 would accelerate time to market (TTM). Probabilistic sensitivity analyses using Monte Carlo simulations were conducted to manage uncertainty. Should the estimated efficiency gains achieved with the EHR4CR platform translate into faster TTM, the expected benefits for the global pharmaceutical oncology sector were estimated at €161.5m (S1), €45.7m (S2), €204.5m (S1+S2), €1906m (S3), and up to €2121.8m (S1+S2+S3) when the scenarios were used sequentially. The results suggest that optimizing clinical trial design and execution with the EHR4CR platform would generate substantial added value for pharmaceutical industry, as main sponsors of clinical trials in Europe, and beyond. Copyright © 2015 Elsevier Inc. All rights reserved.

  4. Theoretical microfluidics

    DEFF Research Database (Denmark)

    Bruus, Henrik

    Microfluidics is a young and rapidly expanding scientific discipline, which deals with fluids and solutions in miniaturized systems, the so-called lab-on-a-chip systems. It has applications in chemical engineering, pharmaceutics, biotechnology and medicine. As the lab-on-a-chip systems grow...... in complexity, a proper theoretical understanding becomes increasingly important. The basic idea of the book is to provide a self-contained formulation of the theoretical framework of microfluidics, and at the same time give physical motivation and examples from lab-on-a-chip technology. After three chapters...... introducing microfluidics, the governing equations for mass, momentum and energy, and some basic flow solutions, the following 14 chapters treat hydraulic resistance/compliance, diffusion/dispersion, time-dependent flow, capillarity, electro- and magneto-hydrodynamics, thermal transport, two-phase flow...

  5. Theoretical Issues

    Energy Technology Data Exchange (ETDEWEB)

    Marc Vanderhaeghen

    2007-04-01

    The theoretical issues in the interpretation of the precision measurements of the nucleon-to-Delta transition by means of electromagnetic probes are highlighted. The results of these measurements are confronted with the state-of-the-art calculations based on chiral effective-field theories (EFT), lattice QCD, large-Nc relations, perturbative QCD, and QCD-inspired models. The link of the nucleon-to-Delta form factors to generalized parton distributions (GPDs) is also discussed.

  6. The clinical benefits of antiretroviral therapy in severely immunocompromised HIV-1-infected patients with and without complete viral suppression

    DEFF Research Database (Denmark)

    Mocroft, Amanda; Bannister, Wendy P; Kirk, Ole

    2012-01-01

    The aim of this study was to determine whether there is a protective effect of combination antiretroviral therapy (cART) on the development of clinical events in patients with ongoing severe immunosuppression....

  7. A Novel Glycinate-based Body Wash: Clinical Investigation Into Ultra-mildness, Effective Conditioning, and Improved Consumer Benefits

    OpenAIRE

    Regan, Jamie; Mollica, Leonel-Maximo; Ananthapadmanabhan, K.P.

    2013-01-01

    Objective: To assess the properties of a novel body wash containing the mild surfactant glycinate. Design: Biochemical and clinical assays. Setting: Research laboratories and clinical sites in the United States and Canada. Participants: Women 18 to 65 years of age (cleansing efficacy); male and female subjects 26 to 63 years of age with mild or moderate dryness and erythema (leg-controlled application test); subjects 5 to 65 years of age with mild-to-moderate eczema (eczema compatibility); an...

  8. Pesquisa e prática clínica: construindo articulações teóricas Research and clinical practice: constructing theoretical links

    Directory of Open Access Journals (Sweden)

    Terezinha Féres-Carneiro

    2008-01-01

    Full Text Available Neste texto, apresentado na Aula Inaugural, proferida no Programa de Pós-graduação em Psicologia do Desenvolvimento da Universidade Federal do Rio Grande do Sul (UFRGS em 10/03/08, discutem-se as articulações construídas pela autora a partir de sua inserção na academia e na prática clínica. A história de um percurso de 36 anos, como docente-pesquisadora e como psicóloga clínica, é relatada, ressaltando o modo indissociável de conceber tais funções. Neste relato, são explicitadas e discutidas as possibilidades de articular diferentes enfoques teórico-técnicos na clínica. Uma tríplice chave de leitura, que considere o intra-psíquico, o interacional e o social, é proposta no atendimento a famílias e casais.In this text, which was presented at the Inaugural Lecture from the Graduate Program of Developmental Psychology at Universidade Federal do Rio Grande do Sul (UFRGS on March 03, 2008, are discussed the links constructed by this author in the academic work as well as in the clinical practice. The history of a 36-year journey as both a professor-researcher and also as a clinical psychologist is reported here, with emphasis on the inseparable way of conceiving such functions. In this account it is explained and discussed the possibilities of articulating different theoretical-technical approaches in the clinic. The proposal for family and couple psychological assistance is a tripartite key of reading which takes into consideration the intra-psychological, the interactional and the social aspects of the aforementioned ones.

  9. Do rheumatoid arthritis patients in clinical practice benefit from switching from infliximab to a second tumor necrosis factor alpha inhibitor?

    DEFF Research Database (Denmark)

    Hjardem, Elisabeth; Østergaard, Mikkel; Pødenphant, Jan

    2007-01-01

    DAS28 improvements in first/second treatment at 3 months were: LOE switchers 1.1/1.6; AE switchers 1.5/0.8. In LOE switchers, a good/moderate EULAR response was more prevalent during the second treatment course than during the first (63% versus 54%, p = 0.02). AE switchers achieved similar EULAR...... biological therapy was higher than of the first, but lower than that of non-switchers. No difference between various sequences of drugs were found. Danish post-marketing data thus support that RA patients may benefit from switching biological therapy....

  10. Derivation of a preliminary clinical prediction rule for identifying a subgroup of patients with low back pain likely to benefit from Pilates-based exercise.

    Science.gov (United States)

    Stolze, Lise R; Allison, Stephen C; Childs, John D

    2012-05-01

    Prospective cohort study. To derive a preliminary clinical prediction rule for identifying a subgroup of patients with low back pain (LBP) likely to benefit from Pilates-based exercise. Pilates-based exercise has been shown to be effective for patients with LBP. However, no previous work has characterized patient attributes for those most likely to have a successful outcome from treatment. Ninety-six individuals with nonspecific LBP participated in the study. Treatment response was categorized based on changes in the Oswestry Disability Questionnaire scores after 8 weeks. An improvement of 50% or greater was categorized as achieving a successful outcome. Thirty-seven variables measured at baseline were analyzed with univariate and multivariate methods to derive a clinical prediction rule for successful outcome with Pilates exercise. Accuracy statistics, receiver-operator curves, and regression analyses were used to determine the association between standardized examination variables and treatment response status. Ninety-five of 96 participants completed the study, with 51 (53.7%) achieving a successful outcome. A preliminary clinical prediction rule with 5 variables was identified: total trunk flexion range of motion of 70° or less, duration of current symptoms of 6 months or less, no leg symptoms in the last week, body mass index of 25 kg/m2 or greater, and left or right hip average rotation range of motion of 25° or greater. If 3 or more of the 5 attributes were present (positive likelihood ratio, 10.64), the probability of experiencing a successful outcome increased from 54% to 93%. These data provide preliminary evidence to suggest that the response to Pilates-based exercise in patients with LBP can be predicted from variables collected from the clinical examination. If subsequently validated in a randomized clinical trial, this prediction rule may be useful to improve clinical decision making in determining which patients are most likely to benefit from

  11. Integrating Positive and Clinical Psychology: Viewing Human Functioning as Continua from Positive to Negative Can Benefit Clinical Assessment, Interventions and Understandings of Resilience

    OpenAIRE

    Johnson, J; Wood, AM

    2017-01-01

    In this review we argue in favour of further integration between the disciplines of positive and clinical psychology. We argue that most of the constructs studied by both positive and clinical psychology exist on continua ranging from positive to negative (e.g., gratitude to ingratitude, anxiety to calmness) and so it is meaningless to speak of one or other field studying the “positive” or the “negative”. However, we highlight historical and cultural factors which have led positive and clinic...

  12. Theoretical physics

    CERN Document Server

    Joos, Georg

    1986-01-01

    Among the finest, most comprehensive treatments of theoretical physics ever written, this classic volume comprises a superb introduction to the main branches of the discipline and offers solid grounding for further research in a variety of fields. Students will find no better one-volume coverage of so many essential topics; moreover, since its first publication, the book has been substantially revised and updated with additional material on Bessel functions, spherical harmonics, superconductivity, elastomers, and other subjects.The first four chapters review mathematical topics needed by theo

  13. Five years of EMA-approved systemic cancer therapies for solid tumours-a comparison of two thresholds for meaningful clinical benefit.

    Science.gov (United States)

    Grössmann, N; Del Paggio, J C; Wolf, S; Sullivan, R; Booth, C M; Rosian, K; Emprechtinger, R; Wild, C

    2017-09-01

    Several societies have proposed frameworks to evaluate the benefit of oncology drugs; one prominent tool is the European Society for Medical Oncology Magnitude of Clinical Benefit Scale (ESMO-MCBS). Our objectives were to investigate the extent of European Medicines Agency (EMA)-approved cancer drugs that meet the threshold for 'meaningful clinical benefit' (MCB), defined by the framework, and determine the change in the distribution of grades when an adapted version that addresses the scale's limitations is applied. We identified cancer drugs approved by the EMA (2011-2016). We previously proposed adaptations to the ESMO-MCBS addressing its main limitations, including the use of the lower limit of the 95% confidence interval in assessing the hazard ratio. To assess the MCB, both the original and adapted ESMO-MCBS were applied to the respective approval studies. In total, we identified 70 approval studies for 38 solid cancer drugs. 21% of therapies met the MCB threshold by the original ESMO-MCBS criteria. In contrast, only 11% of therapies met the threshold for MCB when the adapted ESMO-MCBS was applied. Thus 89% and 79% of therapies did not meet the MCB threshold in the adapted and original ESMO-MCBS, respectively. In most of the cancer drugs, the MCB threshold is not met at the time of approval when measured using both ESMO-MCBS scales. Since approval status does not translate into a MCB, stakeholders and decision makers should focus on the benefit/risk ratio of anticancer drugs to assure an appropriate allocation of resources in health care systems. Copyright © 2017 The Author(s). Published by Elsevier Ltd.. All rights reserved.

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

    Science.gov (United States)

    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.…

  15. 21 CFR 50.53 - Clinical investigations involving greater than minimal risk and no prospect of direct benefit to...

    Science.gov (United States)

    2010-04-01

    ... 21 Food and Drugs 1 2010-04-01 2010-04-01 false Clinical investigations involving greater than... 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 that is of vital importance for the understanding or...

  16. Scientific imperatives, clinical implications, and theoretical underpinnings for the investigation of the relationship between genetic variables and patient-reported quality-of-life outcomes.

    Science.gov (United States)

    Sprangers, Mirjam A G; Sloan, Jeff A; Barsevick, Andrea; Chauhan, Cynthia; Dueck, Amylou C; Raat, Hein; Shi, Quiling; Van Noorden, Cornelis J F

    2010-12-01

    There is emerging evidence for a genetic basis of patient-reported quality-of-life (QOL) outcomes that can ultimately be incorporated into clinical research and practice. Objectives are (1) to provide arguments for the timeliness of investigating the genetic basis of QOL given the scientific advances in genetics and patient-reported QOL research; (2) to describe the clinical implications of such investigations; (3) to present a theoretical foundation for investigating the genetic underpinnings of QOL; and (4) to describe a series of papers resulting from the GENEQOL Consortium that was established to move this work forward. Discussion of scientific advances based on relevant literature. In genetics, technological advances allow for increases in speed and efficiency and decreases in costs in exploring the genetic underpinnings of disease processes, drug metabolism, treatment response, and survival. In patient-based research, advances yield empirically based and stringent approaches to measurement that are scientifically robust. Insights into the genetic basis of QOL will ultimately allow early identification of patients susceptible to QOL deficits and to target care. The Wilson and Cleary model for patient-reported outcomes was refined by incorporating the genetic underpinnings of QOL. This series of papers provides a path for QOL and genetics researchers to work together to move this field forward and to unravel the intricate interplay of the genetic underpinnings of patient-reported QOL outcomes. The ultimate result will be a greater understanding of the process relating disease, patient, and doctor that will have the potential to lead to improved survival, QOL, and health services delivery.

  17. Neurovascular Unit Dysfunction and Blood–Brain Barrier Hyperpermeability Contribute to Schizophrenia Neurobiology: A Theoretical Integration of Clinical and Experimental Evidence

    Directory of Open Access Journals (Sweden)

    Souhel Najjar

    2017-05-01

    Full Text Available Schizophrenia is a psychotic disorder characterized by delusions, hallucinations, negative symptoms, as well as behavioral and cognitive dysfunction. It is a pathoetiologically heterogeneous disorder involving complex interrelated mechanisms that include oxidative stress and neuroinflammation. Neurovascular endothelial dysfunction and blood–brain barrier (BBB hyperpermeability are established mechanisms in neurological disorders with comorbid psychiatric symptoms such as epilepsy, traumatic brain injury, and Alzheimer’s disease. Schizophrenia is frequently comorbid with medical conditions associated with peripheral vascular endothelial dysfunction, such as metabolic syndrome, cardiovascular disease, and diabetes mellitus. However, the existence and etiological relevance of neurovascular endothelial dysfunction and BBB hyperpermeability in schizophrenia are still not well recognized. Here, we review the growing clinical and experimental evidence, indicating that neurovascular endotheliopathy and BBB hyperpermeability occur in schizophrenia patients. We present a theoretical integration of human and animal data linking oxidative stress and neuroinflammation to neurovascular endotheliopathy and BBB breakdown in schizophrenia. These abnormalities may contribute to the cognitive and behavioral symptoms of schizophrenia via several mechanisms involving reduced cerebral perfusion and impaired homeostatic processes of cerebral microenvironment. Furthermore, BBB disruption can facilitate interactions between brain innate and peripheral adaptive immunity, thereby perpetuating harmful neuroimmune signals and toxic neuroinflammatory responses, which can also contribute to the symptoms of schizophrenia. Taken together, these findings support the “mild encephalitis” hypothesis of schizophrenia. If neurovascular abnormalities prove to be etiologically relevant to the neurobiology of schizophrenia, then targeting these abnormalities may represent a

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

    Science.gov (United States)

    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

  19. Noncontrast chest computed tomography immediately after transarterial chemoembolization in patients with hepatocellular carcinoma: Clinical benefits and effect of radiation reduction on image quality in low-dose scanning

    Energy Technology Data Exchange (ETDEWEB)

    Choi, Joon-Il [Center for Liver Cancer, Research Institute and Hospital, National Cancer Center, Goyang-si (Korea, Republic of); Department of Radiology, Research Institute and Hospital, National Cancer Center, Goyang-si (Korea, Republic of); Department of Radiology, Seoul St. Mary' s Hospital, The Catholic University of Korea, Seoul (Korea, Republic of); Kim, Hyun Beom, E-mail: dockhb@naver.com [Center for Liver Cancer, Research Institute and Hospital, National Cancer Center, Goyang-si (Korea, Republic of); Department of Radiology, Research Institute and Hospital, National Cancer Center, Goyang-si (Korea, Republic of); Kim, Min Ju; Lee, Jong Seok [Department of Radiology, Research Institute and Hospital, National Cancer Center, Goyang-si (Korea, Republic of); Koh, Young Whan; An, Sang Bu [Center for Liver Cancer, Research Institute and Hospital, National Cancer Center, Goyang-si (Korea, Republic of); Department of Radiology, Research Institute and Hospital, National Cancer Center, Goyang-si (Korea, Republic of); Ko, Heung-kyu [Department of Radiology, Research Institute and Hospital, National Cancer Center, Goyang-si (Korea, Republic of); Park, Joong-Won [Center for Liver Cancer, Research Institute and Hospital, National Cancer Center, Goyang-si (Korea, Republic of)

    2011-11-15

    Purpose: To evaluate the clinical benefits of noncontrast chest computed tomography (CT) immediately after transarterial chemoembolization in patients with hepatocellular carcinoma and to assess the effect of radiation reduction on image quality in low-dose scanning. Materials and methods: From June to October 2010, we performed standard-dose, noncontrast chest CTs immediately after transarterial chemoembolization in 160 patients and low-dose CTs in 88 patients. We reviewed the entire noncontrast chest CTs and follow-up CTs to reveal the clinical benefits of CT evaluation immediately after transarterial chemoembolization. Using two independent readers, we also retrospectively evaluated the radiation dose and image quality in terms of the image noise, contrast between the liver parenchyma and iodized oil and diagnostic acceptability for the evaluation of treatment response after transarterial chemoembolization. Results: In 5.2% of the patients, additional treatment was performed immediately after the interpretation of the noncontrast chest CT, and additional pulmonary lesions were found in 8.5% of the patients. The measured mean dose-length product for the low-dose scanning was 18.4% of that of the standard-dose scanning. The image noise was significantly higher with the low-dose scanning (p < 0.001). However, all of the low-dose CT scans were diagnostically acceptable, and the mean scores for the subjective assessments of the contrast and diagnostic acceptability showed no significant differences for either reader. Conclusion: A noncontrast chest CT immediately after transarterial chemoembolization has some clinical benefits for immediate decision making and detecting pulmonary lesions. Low-dose, noncontrast chest CTs immediately after transarterial chemoembolization consistently provide diagnostically acceptable images and information on treatment response in patients who have undergone transarterial chemoembolization.

  20. Growing insights into the potential benefits and risks of activated protein C administration in sepsis: a review of preclinical and clinical studies

    Directory of Open Access Journals (Sweden)

    Laith Altaweel

    2009-09-01

    Full Text Available Laith Altaweel, Daniel Sweeney, Xizhong Cui, Amisha Barochia, Charles Natanson, Peter Q EichackerCritical Care Medicine Department, Clinical Center, National Institutes of Health, Bethesda, MD, USAAbstract: Recombinant human activated protein C (rhAPC was developed to reduce excessive coagulant and inflammatory activity during sepsis. Basic and clinical research has suggested these pathways contribute to the pathogenesis of this lethal syndrome and are inhibited by rhAPC. Based in large part on the results of a single multicenter randomized controlled trial, rhAPC was first approved in 2001 by the US Food and Drug Administration (FDA as adjunctive therapy in septic patients with a high risk of death. This was followed closely by approval in Europe, Australia, and New Zealand. At the original FDA review of rhAPC, concerns were raised as to whether a confirmatory trial should be done before final regulatory approval because of concerns that rhAPCs bleeding risk might outweigh its potential benefit during clinical use. Since 2001, continuing basic and clinical research has further elucidated the complex role activated protein C may have in both adaptive and maladaptive responses during sepsis. Moreover, subsequent controlled trials in other types of septic patients and observational studies appear to support earlier concerns that the benefit-to-risk ratio of rhAPC may not support its clinical use. This experience has prompted additional trials presently underway, to define whether treatment with rhAPC as it was originally indicated in septic patients with persistent shock, is safe and effective. Until such trials are complete, physicians employing this agent must carefully consider which patients may be appropriate candidates for rhAPC administration.Keywords: rhAPC, treatment, sepsis

  1. Molecular and physiological actions of quercetin: need for clinical trials to assess its benefits in human disease.

    Science.gov (United States)

    Miles, Sarah L; McFarland, Margaret; Niles, Richard M

    2014-11-01

    There is a growing realization that natural products such as phytochemicals can be used in diets or as supplements to prevent or treat human disease. The disciplines of epidemiology, pharmacognosy, and molecular biology have provided evidence that certain dietary constituents decrease blood pressure, influence immune and neuronal function, affect the incidence of cancer, and ameliorate the abnormal properties of cancer cells. Molecular studies have uncovered the interesting feature that most phytochemicals have multiple modes of action. This review focuses on the flavonoid phytochemical quercetin and describes the myriad of conditions in which quercetin affects a number of physiological processes. Despite the compelling information available, including a number of animal studies, translation of these findings into human clinical trials has been slow. The status of current clinical research on quercetin is summarized, and direction for further research is suggested. © 2014 International Life Sciences Institute.

  2. Heart failure clinics are associated with clinical benefit in both tertiary and community care settings: Data from the Improving Cardiovascular Outcomes in Nova Scotia (ICONS) registry

    Science.gov (United States)

    Howlett, Jonathan G; Mann, O Elizabeth; Baillie, Robert; Hatheway, Ronald; Svendsen, Anna; Benoit, Rosalind; Ferguson, Carol; Wheatley, Marlene; Johnstone, David E; Cox, Jafna L

    2009-01-01

    BACKGROUND: Heart failure (HF) clinics are known to improve outcomes of patients with HF. Studies have been limited to single, usually tertiary centres whose experience may not apply to the general HF population. OBJECTIVES: To determine the effectiveness of HF clinics in reducing death or all-cause rehospitalization in a real-world population. METHODS: A retrospective analysis of the Improving Cardiovascular Outcomes in Nova Scotia (ICONS) disease registry was performed. All 8731 patients with a diagnosis of HF (844 managed in HF clinics) who were discharged from the hospital between October 15, 1997, and July 1, 2000, were identified. Patients enrolled in any one of four HF clinics (two community-based and two academic-based) were compared with those who were not. The primary outcome was the one-year combined hospitalization and mortality. RESULTS: Patients followed in HF clinics were younger (68 versus 75 years), more likely to be men (63% versus 48%), and had a lower ejection fraction (35% versus 44%), lower systolic blood pressure (137 mmHg verus 146 mmHg) and lower serum creatinine (121 μmol/L versus 130 μmol/L). There was no difference in the prevalence of hypertension (56%), diabetes (35%) or stroke/transient ischemic attack (16%). The one-year mortality rate was 23%, while 31% of patients were rehospitalized; the combined end point was 51%. Enrollment in an HF clinic was independently associated with reduced risk of total mortality (hazard ratio [HR] 0.69 [95% CI 0.51 to 0.90], P=0.008; number needed to treat for one year to prevent the occurrence of one event [NNT]=16), all-cause hospital readmission (HR 0.27 [95% CI 0.21 to 0.36], P<0.0001; NNT=4), and combined mortality or hospital readmission (HR 0.73 [95% CI 0.60 to 0.89], P<0.0015; NNT=5). DISCUSSION: HF clinics are associated with reductions in rehospitalization and mortality in an unselected HF population, independent of whether they are academic- or community-based. Such clinics should be made

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

    Directory of Open Access Journals (Sweden)

    Alfredo eSantalla

    2014-12-01

    Full Text Available 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 (P0.05 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 class 1 for

  4. [Breastfeeding (part one): Frequency, benefits and drawbacks, optimal duration and factors influencing its initiation and prolongation. Clinical guidelines for practice].

    Science.gov (United States)

    Chantry, A A; Monier, I; Marcellin, L

    2015-12-01

    The objectives were to on assess the frequency and the duration of breastfeeding in France. On the other hand, the objectives were to identify its benefits and drawbacks, and to study the factors influencing its initiation and its extension. Bibliographic research in Medline, Google Scholar and in the Cochrane Library. Breastfeeding concerns in France about 70% of children at birth (EL2). Its median duration is about 15 weeks and 3 weeks ½ for exclusive breastfeeding. At three months, only one third of children breastfed at birth are still being breastfed (EL2). Whether this is due to the composition of breast milk or the behavior of mothers with their children or their socio-cultural level, or even by all these components at once, breastfeeding is associated with better cognitive development children (EL2). This effect is even more reinforced that mothers breastfeed exclusively and prolonged (EL2). As part of the prevention of many diseases (ear infections, gastrointestinal infections, atopic diseases, obesity and cardiovascular diseases…), exclusive and prolonged breastfeeding (grade B) between 4 to 6 months is recommended (professional consensus). Breastfeeding is not a means of preventing postpartum depression (professional consensus). To reduce the incidence of breast cancer, prolonged breastfeeding is recommended (grade B). In order to increase the rate of initiation of breastfeeding as well as its duration, it is recommended that health professionals work closely with mothers in their project (grade A), the breastfeeding promotion messages include message to husbands (grade B), and to promote breastfeeding on demand without fixed interval between feedings (grade B). However, there is not enough data to recommend the use of a specific position during breastfeeding, or the use of one or two breast or to early start breastfeeding or not (professional consensus). Exclusive and extended breastfeeding is recommended (grade B) between 4 to 6 months (professional

  5. The economic benefits of increasing kangaroo skin-to-skin care and breastfeeding in neonatal units: analysis of a pragmatic intervention in clinical practice.

    Science.gov (United States)

    Lowson, Karin; Offer, Clare; Watson, Julie; McGuire, Bill; Renfrew, Mary J

    2015-01-01

    A number of significant recent research studies have used techniques of economic modelling to demonstrate the potential benefits of increasing breastfeeding rates in the UK overall, and specifically in neonatal care. This paper complements this growing body of evidence by presenting an economic analysis of data from an actual intervention, the 'Getting It Right From the Start' programme, which took place in the north of the UK during 2011-12, with the aim of increasing breastfeeding and kangaroo skin-to-skin care rates in neonatal units. 'Getting It Right from the Start' was a pragmatic, multifaceted programme of change delivered under the auspices of the regional Health Innovation and Education Cluster, of which 17 were established in the UK in 2010. It engaged with 18 neonatal units in two Neonatal Networks with the aim of increasing kangaroo skin-to-skin care and breastfeeding rates. As part of the evaluation of the programme, we conducted an economic study comparing the overall costs and benefits of the intervention. Overall, the economic analysis demonstrated that for every £1 invested in the intervention to increase kangaroo skin-to-skin care and breastfeeding rates, between £4.00 and £13.82 of benefit was generated. This was spread across different healthcare settings and the timescale for the realisation of benefits will vary. The increases in kangaroo skin-to-skin care generated the greatest cost savings, with potential cost savings ranging between £668,000 (minimum cost assumptions) to more than £2 m (maximum cost assumptions). Increases in breastfeeding associated with the project generated between £68,486 and £582,432. The majority of the cost savings generated were associated with reductions in cases of gastroenteritis and necrotising enterocolitis. This was one of the first economic evaluations of an actual intervention to increase breastfeeding and kangaroo skin-to-skin care in neonatal units. It complements the existing economic models by

  6. Core benefits

    National Research Council Canada - National Science Library

    Keith, Brian W

    2010-01-01

    This SPEC Kit explores the core employment benefits of retirement, and life, health, and other insurance -benefits that are typically decided by the parent institution and often have significant governmental regulation...

  7. Clinical benefit of a gluten-free diet in type 1 diabetic children with screening-detected celiac disease

    DEFF Research Database (Denmark)

    Hansen, Dorte; Brock-Jacobsen, Bendt; Lund, Elisabeth

    2006-01-01

    OBJECTIVE: This study was performed to 1) determine the prevalence of celiac disease in Danish children with type 1 diabetes and 2) estimate the clinical effects of a gluten-free diet (GFD) in patients with diabetes and celiac disease. RESEARCH DESIGN AND METHODS: In a region comprising 24......% of the Danish population, all patients celiac disease was suspected in patients with endomysium and tissue transglutaminase antibodies in serum and confirmed by intestinal biopsy. Patients with celiac...... disease were followed for 2 years while consuming a GFD. RESULTS: In 28 of 33 patients with celiac antibodies, an intestinal biopsy showed villous atrophy. In 5 patients, celiac disease had been diagnosed previously, giving an overall prevalence of 12.3% (95% CI 8.6-16.9). Patients with celiac disease had...

  8. Considering benefits and harms of duloxetine for treatment of stress urinary incontinence: a meta-analysis of clinical study reports

    DEFF Research Database (Denmark)

    Maund, Emma; Guski, Louise Schow; Gøtzsche, Peter C.

    2017-01-01

    of duloxetine include mental health problems and suicidality. We obtained clinical study reports from the European Medicines Agency concerning use of this drug for stress urinary incontinence. METHODS: We performed a meta-analysis of 4 randomized placebo-controlled trials of duloxetine (involving a total...... and changes in quality-of-life scores, such as Patient Global Impression of Improvement rating) and harms (both general harms, including discontinuation because of adverse events, and harms related to suicidality, violent behaviour and their potential precursors, such as akathisia and activation [stimulating...... to harm were 7 (95% CI 6 to 8) for discontinuing because of an adverse event and 7 (95% CI 6 to 9) for experiencing an activation event. No suicidality, violence or akathisia events were noted. INTERPRETATION: Although duloxetine is effective for stress urinary incontinence in women, the rates...

  9. Considering benefits and harms of duloxetine for treatment of stress urinary incontinence: a meta-analysis of clinical study reports

    DEFF Research Database (Denmark)

    Maund, Emma; Guski, Louise Schow; Gøtzsche, Peter C.

    2017-01-01

    effects of duloxetine include mental health problems and suicidality. We obtained clinical study reports from the European Medicines Agency concerning use of this drug for stress urinary incontinence. Methods: We performed a meta-analysis of 4 randomized placebo-controlled trials of duloxetine (involving...... of incontinence and changes in quality-of-life scores, such as Patient Global Impression of Improvement rating) and harms (both general harms, including discontinuation because of adverse events, and harms related to suicidality, violent behaviour and their potential precursors, such as akathisia and activation...... [stimulating effects such as insomnia, anxiety and agitation]). Results: Duloxetine was significantly better than placebo in terms of percentage change in weekly incontinence episodes (mean difference -13.56%, 95% confidence interval [CI] -21.59% to -5.53%) and change in Incontinence Quality of Life total...

  10. Theoretical Physics 1. Theoretical Mechanics

    Energy Technology Data Exchange (ETDEWEB)

    Dreizler, Reiner M.; Luedde, Cora S. [Frankfurt Univ. (Germany). Inst. fuer Theoretische Physik

    2010-07-01

    After an introduction to basic concepts of mechanics more advanced topics build the major part of this book. Interspersed is a discussion of selected problems of motion. This is followed by a concise treatment of the Lagrangian and the Hamiltonian formulation of mechanics, as well as a brief excursion on chaotic motion. The last chapter deals with applications of the Lagrangian formulation to specific systems (coupled oscillators, rotating coordinate systems, rigid bodies). The level of this textbook is advanced undergraduate. The authors combine teaching experience of more than 40 years in all fields of Theoretical Physics and related mathematical disciplines and thorough knowledge in creating advanced eLearning content. The text is accompanied by an extensive collection of online material, in which the possibilities of the electronic medium are fully exploited, e.g. in the form of applets, 2D- and 3D-animations. (orig.)

  11. Clinical and economic benefits of integrated pump/CGM technology therapy in patients with type 1 diabetes in Colombia.

    Science.gov (United States)

    Gomez, Ana Maria; Alfonso-Cristancho, Rafael; Orozco, John Jairo; Lynch, Peter Matthew; Prieto, Diana; Saunders, Rhodri; Roze, Stephane; Valencia, Juan Esteban

    2016-11-01

    To assess the long-term clinical and economic impact of integrated pump/CGM technology therapy as compared to multiple daily injections (MDI), for the treatment of type 1 diabetes (T1D) in Colombia. The CORE Diabetes Model was used to simulate a hypothetical cohort of patients with T1D. Mean baseline characteristics were taken from a clinical study conducted in Colombia and a healthcare payer perspective was adopted, with a 5% annual discount rate applied to both costs and outcomes. The integrated pump/CGM improved mean life expectancy by 3.51 years compared with MDI. A similar increase occurred in mean quality-adjusted life expectancy with an additional 3.81 quality-adjusted life years (QALYs). Onset of diabetes-related complications was also delayed as compared to MDI, and mean survival time free of complication increased by 1.74 years with integrated pump/CGM. Although this increased treatment costs of diabetes as compared to MDI, savings were achieved thanks to reduced expenditure on diabetes-related complications. The estimated incremental cost-effectiveness ratio (ICER) for SAP was Colombian Pesos (COP) 44,893,950 (approximately USD$23,200) per QALY gained. Improved blood glucose control associated to integrated pump/CGM results in a decreased incidence of diabetes-related complications and improves life expectancy as compared to MDI. Using recommended thresholds from the World Health Organization and previous coverage decisions about health technologies in Colombia, it is a cost-effective alternative to MDI for the treatment of type 1 diabetes in Colombia. Copyright © 2016 SEEN. Publicado por Elsevier España, S.L.U. All rights reserved.

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

    Science.gov (United States)

    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 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 class 1 for disease severity.

  13. Benefits of Repetitive Transcranial Magnetic Stimulation (rTMS for Spastic Subjects: Clinical, Functional, and Biomechanical Parameters for Lower Limb and Walking in Five Hemiparetic Patients

    Directory of Open Access Journals (Sweden)

    Luc Terreaux

    2014-01-01

    Full Text Available Introduction. Spasticity is a disabling symptom resulting from reorganization of spinal reflexes no longer inhibited by supraspinal control. Several studies have demonstrated interest in repetitive transcranial magnetic stimulation in spastic patients. We conducted a prospective, randomized, double-blind crossover study on five spastic hemiparetic patients to determine whether this type of stimulation of the premotor cortex can provide a clinical benefit. Material and Methods. Two stimulation frequencies (1 Hz and 10 Hz were tested versus placebo. Patients were assessed clinically, by quantitative analysis of walking and measurement of neuromechanical parameters (H and T reflexes, musculoarticular stiffness of the ankle. Results. No change was observed after placebo and 10 Hz protocols. Clinical parameters were not significantly modified after 1 Hz stimulation, apart from a tendency towards improved recruitment of antagonist muscles on the Fügl-Meyer scale. Only cadence and recurvatum were significantly modified on quantitative analysis of walking. Neuromechanical parameters were modified with significant decreases in Hmax⁡ /Mmax⁡ and T/Mmax⁡ ratios and stiffness indices 9 days or 31 days after initiation of TMS. Conclusion. This preliminary study supports the efficacy of low-frequency TMS to reduce reflex excitability and stiffness of ankle plantar flexors, while clinical signs of spasticity were not significantly modified.

  14. Long-term combination therapy with infliximab plus azathioprine predicts sustained steroid-free clinical benefit in steroid-dependent ulcerative colitis.

    Science.gov (United States)

    Armuzzi, Alessandro; Pugliese, Daniela; Danese, Silvio; Rizzo, Gianluca; Felice, Carla; Marzo, Manuela; Andrisani, Gianluca; Fiorino, Gionata; Nardone, Olga Maria; De Vitis, Italo; Papa, Alfredo; Rapaccini, Gian Lodovico; Guidi, Luisa

    2014-08-01

    Infliximab (IFX) has demonstrated effectiveness for inducing 12-month steroid-free clinical remission in patients with steroid-dependent ulcerative colitis (UC), but long-term data are lacking. The aim of the study was to describe the long-term outcome of IFX treatment in steroid-dependent UC and investigate if predictors of sustained clinical response and colectomy could be identified. Consecutive patients with steroid-dependent UC treated with IFX were studied. The coprimary prespecified outcomes were sustained clinical response in patients who achieved clinical remission or response after IFX induction and colectomy-free survival. Secondary analyses were addressed to look for predictors of sustained clinical response and colectomy. After induction, 76% (96/126) of patients achieved clinical benefit. The median duration of follow-up on IFX maintenance therapy was 41.5 months (interquartile range, 26-45). Sixty-four percent (46/96) of patients had sustained clinical response at median follow-up. Colectomy-free survival was 77% at median follow-up. Combination therapy of IFX with thiopurines was an independent predictor of sustained clinical response (P < 0.0001; hazard ratio [HR], 3.98; 95% confidence interval [CI], 1.73-9.14). Independent predictors of colectomy were Mayo endoscopic subscore of 3 at baseline (P = 0.04; HR, 2.77; 95% CI, 1.09-7.05) and high C-reactive protein after induction (P = 0.001; HR, 5.65; 95% CI, 2.03-15.7). Thiopurine naive status (P = 0.025; HR, 0.34; 95% CI, 0.13-0.87) was protective from colectomy. Long-term IFX treatment is effective in inducing sustained clinical response in patients with steroid-dependent UC. Combination therapy is predictive of sustained clinical response in the long-term. Patients with more severe endoscopic lesions at baseline and high C-reactive protein after induction are at higher risk of colectomy. Conversely, thiopurine naive status is protective from colectomy.

  15. A systematic review of the evidence of reduced allergenicity and clinical benefit of food hydrolysates in dogs with cutaneous adverse food reactions.

    Science.gov (United States)

    Olivry, Thierry; Bizikova, Petra

    2010-02-01

    Several hydrolysate-based diets have been commercialized for helping diagnose or treat dogs with cutaneous adverse food reactions (CAFR). This systematic review was performed to examine the evidence in favour of reduced immunological and clinical allergenicity of hydrolysates in dogs with CAFR. Citation databases, meeting abstracts and article bibliographies were scanned for relevant citations, and companies were contacted to provide unpublished reports. Eleven studies relevant to this study were identified. Some evidence of reduced serum IgE binding to a soy hydrolysate (1 study) and decreased intradermal test reactivity to hydrolysed proteins (three studies) was found. In four reports, the feeding of dogs suspected of having CAFR with hydrolysate-based diets reduced or eliminated clinical signs in a variable proportion of subjects. The percentage of dogs with CAFR that still reacted to these hydrolysate-based diets could not be assessed, however. Importantly, up to 50% of dogs with CAFR enrolled in three controlled studies exhibited increases in clinical signs after ingesting partial hydrolysates derived from foods to which they were hypersensitive. In conclusion, the limited number of studies undertaken point to reduced - but not eliminated - immunological and clinical allergenicity of hydrolysate-based commercial diets. A variable proportion of dogs with CAFR will exhibit a worsening of clinical signs when fed partial hydrolysates. Clinicians must weigh the clinical benefit of these diets versus their high cost and low risk of reduced appetence or gastrointestinal sign development. At this time, hydrolysate-containing diets are probably best used in dogs suspected not to be hypersensitive to their individual components.

  16. Benefit of adjunct universal rectal screening for Chlamydia genital infections in women attending Canadian sexually transmitted infection clinics.

    Science.gov (United States)

    Thanh, Nguyen X; Akpinar, Ilke; Gratrix, Jennifer; Plitt, Sabrina; Smyczek, Petra; Read, Ron; Jacobs, Philip; Wong, Tom; Singh, Ameeta E

    2017-11-01

    Adding universal rectal screening to urogenital screening should positively impact rectal Chlamydia trachomatis (CT) incidence in affected populations. A dynamic Markov model was used to evaluate costs and outcomes of three rectal CT screening strategies among women attending sexually transmitted infection clinics in Alberta, Canada: universal urogenital-only screening (UG-only), additional selected (exposure-based) rectal screening (UG+SR), and additional universal rectal screening (UG+UR). The model included two mutually exclusive health states: infected and susceptible. Additionally, the model included two rounds of transmission: male sex partners of women infected with rectal-only CT and female sex partners of those men. CT complications impacting patients' quality of life (QALY) were considered. Alberta and Canadian data were used to estimate model inputs. We used a health care perspective, a time period of 10 years, and a discount rate of 3% for analyses. Compared to UG-only screening, the incremental cost effectiveness ratios (ICERs) were CA$34,000 and CA$49,000 per QALY gained for UG+SR and UG+UR screening strategies, respectively. Compared to UG+SR, the ICER was CA$62,000 per QALY gained for the UG+UR strategy. Both adjunct selected and universal rectal screening strategies are cost effective compared to UG-only screening, and UG+UR screening is cost effective when compared to UG+SR screening.

  17. Anti-inflammatory effect as a mechanism of effectiveness underlying the clinical benefits of pelotherapy in osteoarthritis patients: regulation of the altered inflammatory and stress feedback response

    Science.gov (United States)

    Ortega, E.; Gálvez, I.; Hinchado, M. D.; Guerrero, J.; Martín-Cordero, L.; Torres-Piles, S.

    2017-04-01

    The purpose of the present investigation was to evaluate whether an anti-inflammatory effect together with an improvement of the regulation of the interaction between the inflammatory and stress responses underlies the clinical benefits of pelotherapy in osteoarthritis (OA) patients. This study evaluated the effects of a 10-day cycle of pelotherapy at the spa centre `El Raposo' (Spain) in a group of 21 OA patients diagnosed with primary knee OA. Clinical assessments included pain intensity using a visual analog scale; pain, stiffness and physical function using the Western Ontario and McMaster Universities Arthritis Index; and health-related quality of life using the EuroQol-5D questionnaire. Serum inflammatory cytokine levels (IL-1β, TNF-α, IL-8, IL-6, IL-10 and TGF-β) were evaluated using the Bio-Plex® Luminex® system. Circulating neuroendocrine-stress biomarkers, such as cortisol and extracellular 72 kDa heat shock protein (eHsp72), were measured by ELISA. After the cycle of mud therapy, OA patients improved the knee flexion angle and OA-related pain, stiffness and physical function, and they reported a better health-related quality of life. Serum concentrations of IL-1β, TNF-α, IL-8, IL-6 and TGF-β, as well as eHsp72, were markedly decreased. Besides, systemic levels of cortisol increased significantly. These results confirm that the clinical benefits of mud therapy may well be mediated, at least in part, by its systemic anti-inflammatory effects and neuroendocrine-immune regulation in OA patients. Thus, mud therapy could be an effective alternative treatment in the management of OA.

  18. Benefit of general anesthesia monitored by bispectral index compared with monitoring guided only by clinical parameters. Systematic review and meta-analysis

    Directory of Open Access Journals (Sweden)

    Carlos Rogério Degrandi Oliveira

    Full Text Available Abstract Background: The bispectral index parameter is used to guide the titration of general anesthesia; however, many studies have shown conflicting results regarding the benefits of bispectral index monitoring. The objective of this systematic review with meta-analysis is to evaluate the clinical impact of monitoring with the bispectral index parameter. Methods: The search for evidence in scientific information sources was conducted during December 2013 to January 2015, the following primary databases: Medline/PubMed, LILACS, Cochrane, CINAHL, Ovid, SCOPUS and TESES. The criteria for inclusion in the study were randomized controlled trials, comparing general anesthesia monitored, with bispectral index parameter with anesthesia guided solely by clinical parameters, and patients aged over 18 years. The criteria for exclusion were studies involving anesthesia or sedation for diagnostic procedures, and intraoperative wake-up test for surgery of the spine. Results: The use of monitoring with the bispectral index has shown benefits reducing time to extubation, orientation in time and place, and discharge from both the operating room and post anesthetic care unit. The risk of nausea and vomiting after surgery was reduced by 12% in patients monitored with bispectral index. Occurred a reduction of 3% in the risk of cognitive impairment postoperatively at 3 months postoperatively and 6% reduction in the risk of postoperative delirium in patients monitored with bispectral index. Furthermore, the risk of intraoperative memory has been reduced by 1%. Conclusion: Clinically, anesthesia monitoring with the BIS can be justified because it allows advantages from reducing the recovery time after waking, mainly by reducing the administration of general anesthetics as well as the risk of adverse events.

  19. Clinical benefit of midodrine hydrochloride in symptomatic orthostatic hypotension: a phase 4, double-blind, placebo-controlled, randomized, tilt-table study.

    Science.gov (United States)

    Smith, William; Wan, Hong; Much, David; Robinson, Antoine G; Martin, Patrick

    2016-08-01

    Midodrine hydrochloride is a short-acting pressor agent that raises blood pressure in the upright position in patients with orthostatic hypotension. The US Food and Drug Administration's Subpart H approval, under which midodrine was initially approved, requires post-marketing studies to confirm midodrine's clinical benefit in this indication. The purpose of this study was to evaluate the clinical benefit of midodrine with regard to symptom response. This was a double-blind, placebo-controlled, randomized, crossover, multicenter study (NCT01518946). Following screening, patients aged ≥18 years with severe symptomatic orthostatic hypotension and on a stable dose of midodrine for at least 3 months were randomized to treatment with either their previous midodrine dose or placebo on day 1 and the respective alternate treatment on day 2. The primary endpoint measured time to syncopal symptoms or near-syncope using a 45-min tilt-table test at 1 h post-dose. Thirty-three patients were screened for inclusion: 19 received at least one dose of midodrine and had at least one post-dose measurement of the primary endpoint. The least-squares mean time to syncopal symptoms or near-syncope after tilt-table initiation (mean ± standard error) was 1626.6 ± 186.8 s for midodrine and 1105.6 ± 186.8 s for placebo (difference, 521.0 s; 95 % confidence interval 124.2-971.7 s; p = 0.0131). There were 15 adverse events in 10 patients; all of these were mild or moderate in severity, with none considered by the investigators to be related to midodrine. Midodrine is a well-tolerated and clinically effective treatment for symptomatic orthostatic hypotension.

  20. Five-Year Follow-up of Knee Joint Distraction: Clinical Benefit and Cartilaginous Tissue Repair in an Open Uncontrolled Prospective Study.

    Science.gov (United States)

    van der Woude, Jan-Ton A D; Wiegant, Karen; van Roermund, Peter M; Intema, Femke; Custers, Roel J H; Eckstein, Felix; van Laar, Jaap M; Mastbergen, Simon C; Lafeber, Floris P J G

    2017-07-01

    Objective In end-stage knee osteoarthritis, total knee arthroplasty (TKA) may finally become inevitable. At a relatively young age, this comes with the risk of future revision surgery. Therefore, in these cases, joint preserving surgery such as knee joint distraction (KJD) is preferred. Here we present 5-year follow-up data of KJD. Design Patients ( n = 20; age <60 years) with conservative therapy resistant tibiofemoral osteoarthritis considered for TKA were treated. Clinical evaluation was performed by questionnaires. Change in cartilage thickness was quantified on radiographs and magnetic resonance images (MRI). The 5-year changes after KJD were evaluated and compared with the natural progression of osteoarthritis using Osteoarthritis Initiative data. Results Five-years posttreatment, patients still reported clinical improvement from baseline: ΔWOMAC (Western Ontario and McMaster Universities Arthritis Index) +21.1 points (95% CI +8.9 to +33.3; P = 0.002), ΔVAS (visual analogue scale score) pain -27.6 mm (95%CI -13.3 to -42.0; P < 0.001), and minimum radiographic joint space width (JSW) of the most affected compartment (MAC) remained increased as well: Δ +0.43 mm (95% CI +0.02 to +0.84; P = 0.040). Improvement of mean JSW (x-ray) and mean cartilage thickness (MRI) of the MAC, were not statistically different from baseline anymore (Δ +0.26 mm; P = 0.370, and Δ +0.23 mm; P = 0.177). Multivariable linear regression analysis indicated that KJD treatment was associated with significantly less progression in mean and min JSW (x-ray) and mean cartilage thickness (MRI) compared with natural progression (all Ps <0.001). Conclusions KJD treatment results in prolonged clinical benefit, potentially explained by an initial boost of cartilaginous tissue repair that provides a long-term tissue structure benefit as compared to natural progression. Level of evidence, II.

  1. Anti-inflammatory effect as a mechanism of effectiveness underlying the clinical benefits of pelotherapy in osteoarthritis patients: regulation of the altered inflammatory and stress feedback response

    Science.gov (United States)

    Ortega, E.; Gálvez, I.; Hinchado, M. D.; Guerrero, J.; Martín-Cordero, L.; Torres-Piles, S.

    2017-10-01

    The purpose of the present investigation was to evaluate whether an anti-inflammatory effect together with an improvement of the regulation of the interaction between the inflammatory and stress responses underlies the clinical benefits of pelotherapy in osteoarthritis (OA) patients. This study evaluated the effects of a 10-day cycle of pelotherapy at the spa centre `El Raposo' (Spain) in a group of 21 OA patients diagnosed with primary knee OA. Clinical assessments included pain intensity using a visual analog scale; pain, stiffness and physical function using the Western Ontario and McMaster Universities Arthritis Index; and health-related quality of life using the EuroQol-5D questionnaire. Serum inflammatory cytokine levels (IL-1β, TNF-α, IL-8, IL-6, IL-10 and TGF-β) were evaluated using the Bio-Plex® Luminex® system. Circulating neuroendocrine-stress biomarkers, such as cortisol and extracellular 72 kDa heat shock protein (eHsp72), were measured by ELISA. After the cycle of mud therapy, OA patients improved the knee flexion angle and OA-related pain, stiffness and physical function, and they reported a better health-related quality of life. Serum concentrations of IL-1β, TNF-α, IL-8, IL-6 and TGF-β, as well as eHsp72, were markedly decreased. Besides, systemic levels of cortisol increased significantly. These results confirm that the clinical benefits of mud therapy may well be mediated, at least in part, by its systemic anti-inflammatory effects and neuroendocrine-immune regulation in OA patients. Thus, mud therapy could be an effective alternative treatment in the management of OA.

  2. Clinical Response to Gefitinib Retreatment of Lung Adenocarcinoma Patients Who Benefited from An Initial Gefitinib Therapy: A Retrospective Analysis

    Directory of Open Access Journals (Sweden)

    Junling LI

    2012-01-01

    Full Text Available Background and objective Gefitinib is an epidermal growth factor receptor-tyrosine kinase inhibitor (EGFR-TKI that has been widely used for the treatment of non-small cell lung cancer (NSCLC. It is most effective in women, as well as in patients who have never smoked, have pulmonary adenocarcinomas, or are of Asian origin. Several treatment options are available for NSCLC patients who responded to initial gefitinib therapy but demonstrated tumor progression, of which gefitinib readministration is the chosen therapeutic option. The present study aims to evaluate the efficacy and toxicity of gefitinib readministration. Methods The clinical data of 18 patients with NSCLC who had shown partial response (PR or achieved a stable disease (SD status after gefitinib administration and were retreated with gefitinib due to failure of the initial therapy were reviewed and retrospectively analyzed. Results Of the 18 patients studied, 1 (6% showed partial remission (PR, 11 (61% achieved SD, and 6 (33% experienced disease progression. The disease control rate was 67%, and the median progression-free survival was 5.16 months (range, 1 to 24.8 months. The median overall survival from the start of the gefitinib therapy was 39.4 months (range, 15.38 to 52.44 months. Moreover, the median overall survival from the beginning of the 2nd therapy was 12.41 months (range, 3.98 to 38.24 months. Mild toxicity was observed with the 2nd gefitinib therapy. Conclusion The results of the present study indicate that patients with NSCLC may still be expected to achieve prolonged survival through gefitinib readministration if they initially responded to gefitinib and underwent various subsequent treatments.

  3. Clinical Benefit of Everolimus as Second-Line Therapy in Metastatic Renal Cell Carcinoma: The French Retrospective SECTOR Study.

    Science.gov (United States)

    Oudard, Stéphane; Joly, Florence; Geoffrois, Lionnel; Laguerre, Brigitte; Houede, Nadine; Barthelemy, Philippe; Gross-Goupil, Marine; Vano, Yann; Lucidarme, Oliver; Bidault, Francois; Kelkouli, Nadia; Slimane, Khemaies; Escudier, Bernard

    2016-12-01

    Real-world data of everolimus after vascular endothelial growth factor receptor (VEGFR)-tyrosine kinase inhibitor (TKI) therapy in metastatic renal cell carcinoma (mRCC) are limited. The retrospective, noninterventional SECTOR (SECond line with afiniTOR) study (N = 165) assessed outcomes of second-line everolimus after initial VEGFR-TKI (TKI-everolimus, n = 144) and of third-line VEGFR-TKI after everolimus (TKI-everolimus-TKI, n = 59) in patients with mRCC. The primary end point was duration of everolimus therapy for both populations. Median duration was 4.0 months (range, 0.0-33.0 months) for second-line everolimus and 18.0 months (range, 2-78 months) for sequential VEGFR-TKI and everolimus. Median overall survival (OS) for this sequence was 36.0 months (95% confidence interval [CI], 27.0-56.0 months) and was longer for patients who received a first-line TKI for ≥ 9 months (not reached) than for third-line TKI was 24.0 months (95% CI, 19.0-29.0 months). Median OS for this sequence was 41.0 months (95% CI, 25.0-57.0 months) and was significantly longer for patients who received the first-line TKI for ≥ 9 months (37.5 months) than for < 9 months (19.0 months; P < .0001). These results reflect clinical use of sequential TKI-everolimus and TKI-everolimus-TKI and provide additional evidence that everolimus could be an option in second-line therapy in mRCC. Results of the CheckMate-025 (Nivolumab versus Everolimus in Advanced Renal-Cell Carcinoma) and METEOR (Metastatic RCC Phase 3 Study Evaluating Cabozantinib versus Everolimus) studies might change the treatment landscape. Copyright © 2016 Elsevier Inc. All rights reserved.

  4. Theoretical Mechanics Theoretical Physics 1

    CERN Document Server

    Dreizler, Reiner M

    2011-01-01

    After an introduction to basic concepts of mechanics more advanced topics build the major part of this book. Interspersed is a discussion of selected problems of motion. This is followed by a concise treatment of the Lagrangian and the Hamiltonian formulation of mechanics, as well as a brief excursion on chaotic motion. The last chapter deals with applications of the Lagrangian formulation to specific systems (coupled oscillators, rotating coordinate systems, rigid bodies). The level of this textbook is advanced undergraduate. The authors combine teaching experience of more than 40 years in all fields of Theoretical Physics and related mathematical disciplines and thorough knowledge in creating advanced eLearning content. The text is accompanied by an extensive collection of online material, in which the possibilities of the electronic medium are fully exploited, e.g. in the form of applets, 2D- and 3D-animations. - A collection of 74 problems with detailed step-by-step guidance towards the solutions. - A col...

  5. Net clinical benefit of new oral anticoagulants (dabigatran, rivaroxaban, apixaban) versus no treatment in a 'real world' atrial fibrillation population: a modelling analysis based on a nationwide cohort study.

    Science.gov (United States)

    Banerjee, Amitava; Lane, Deirdre A; Torp-Pedersen, Christian; Lip, Gregory Y H

    2012-03-01

    The concept of net clinical benefit has been used to quantify the balance between risk of ischaemic stroke (IS) and risk of intracranial haemorrhage (ICH) with the use oral anticoagulant therapy (OAC) in the setting of non-valvular atrial fibrillation (AF), and has shown that patients at highest risk of stroke and thromboembolism gain the greatest benefit from OAC with warfarin. There are no data for the new OACs, that is, dabigatran, rivaroxaban and apixaban, as yet. We calculated the net clinical benefit balancing IS against ICH using data from the Danish National Patient Registry on patients with non-valvular AF between 1997-2008, for dabigatran, rivaroxaban and apixaban on the basis of recent clinical trial outcome data for these new OACs. In patients with CHADS(2)=0 but at high bleeding risk, apixaban and dabigatran 110 mg bid had a positive net clinical benefit. At CHA(2)DS(2)-VASc=1, apixaban and both doses of dabigatran (110 mg and 150 mg bid) had a positive net clinical benefit. In patients with CHADS(2) score≥1 or CHA(2)DS(2)-VASc≥2, the three new OACs (dabigatran, rivaroxaban and apixaban) appear superior to warfarin for net clinical benefit, regardless of risk of bleeding. When risk of bleeding and stroke are both high, all three new drugs appear to have a greater net clinical benefit than warfarin. In the absence of head-to-head trials for these new OACs, our analysis may help inform decision making processes when all these new OACs become available to clinicians for stroke prevention in AF. Using 'real world' data, our modelling analysis has shown that when the risk of bleeding and stroke are both high, all three new drugs appear to have a greater net clinical benefit compared to warfarin.

  6. Long-term benefit of sunitinib in patients with metastatic renal cell carcinoma in Latin America: retrospective analysis of patient clinical characteristics

    Directory of Open Access Journals (Sweden)

    Smaletz O

    2016-11-01

    Full Text Available Oren Smaletz,1 Matias Chacón,2 Ludmila de Oliveira Koch,1 Daniela R de Carvalho Rocha,1 Fernanda C Cardoso1 1Department of Oncology, Hospital Israelita Albert Einstein, São Paulo, Brazil; 2Medical Oncology Department, Alexander Fleming Institute, Buenos Aires, Argentina Objective: To describe the clinical characteristics of Latin American patients with metastatic renal cell carcinoma (mRCC who experienced a progression-free survival (PFS for at least 15 months following treatment with sunitinib. Patients and methods: In this retrospective analysis, mRCC patients in two institutions in Latin America received sunitinib at a starting dose of either 50 mg/day for 4 weeks followed by 2 weeks off treatment (Schedule 4/2 in repeated 6-week cycles or sunitinib 37.5 mg on a continuous daily dosing schedule. Clinical characteristics, tolerability, and PFS data were collected. Results: Twenty-nine patients with long-term clinical benefit from sunitinib were identified between September 2005 and August 2009. Median PFS was 23 months (range: 15–54 months. Two of the 29 patients with prolonged PFS achieved a complete response and additional eleven had a partial response. Most patients were aged <60 years, had good performance status, favorable or intermediate Memorial Sloan Kettering Cancer Center prognostic risk, and disease limited to one or two sites. Dose reduction was necessary in all patients who started sunitinib at 50 mg/day administered on Schedule 4/2. Adverse events leading to dose reduction included grade 3 hand–foot syndrome, mucositis, fatigue, and hypertension. At the time of data cutoff, four patients were still receiving sunitinib treatment. Conclusion: Extended PFS can be achieved in Latin American patients with mRCC treated with sunitinib. Although the small sample size and retrospective nature of this evaluation preclude the identification of pretreatment predictive factors contributing to this benefit, the current analysis warrants

  7. Unemployment Benefit Exhaustion

    DEFF Research Database (Denmark)

    Filges, Trine; Pico Geerdsen, Lars; Knudsen, Anne-Sofie Due

    2015-01-01

    This systematic review studied the impact of exhaustion of unemployment benefits on the exit rate out of unemployment and into employment prior to benefit exhaustion or shortly thereafter. Method: We followed Campbell Collaboration guidelines to prepare this review, and ultimately located 12...... studies for final analysis and interpretation. Twelve studies could be included in the data synthesis. Results: We found clear evidence that the prospect of exhaustion of benefits results in a significantly increased incentive for finding work. Discussion: The theoretical suggestion that the prospect...... of exhaustion of benefits results in an increased incentive for finding work has been confirmed empirically by measures from seven different European countries, the United States, and Canada. The results are robust in the sense that sensitivity analyses evidenced no appreciable changes in the results. We found...

  8. Benefits in clinical dermatology from methodological and technological innovations in laser and optical technologies in inter-and multi-disciplinary research

    Science.gov (United States)

    Eikje, N. Skrebova

    2008-06-01

    Benefits of employing laser and optical technologies in clinical dermatology are enormous, including solving the complex of questions in diagnosis and treatments of many skin diseases; introducing new methods of diagnosis, treatment and its evaluation; advancing fundamental understanding not only of physiology of skin itself, but also of pathophysiology of different dermatological diseases and conditions. Through numerous innovations in laser and optical technologies a variety of specific and important information has become available in clinical dermatology on real-time normal and lesional skin characterization and visualization, on different type and pattern recognition, on monitoring of several dermatological conditions, on assessment of various parameters for measuring dynamics of skin lesions with further possibilities to assess severity of skin symptoms, and on evaluation of different treatment regimes and their comparisons. After a decade of experiences in inter- and multi-disciplinary research I would like to share the wisdom and pitfalls of my work how to get laser and optical technologies into clinical practice of dermatological interest, that are discussed in the paper.

  9. A preliminary case series evaluating the safety and immediate to short-term clinical benefits of joint mobilization in hemophilic arthritis of the lower limb.

    Science.gov (United States)

    Scaddan, Emma; Rowell, John; O'Leary, Shaun

    2017-09-01

    Arthritis resulting from recurrent intra-articular bleeding in individuals with hemophilia can be severely debilitating due to joint pain and stiffness with subsequent loss of mobility and function. Very limited studies have investigated the potential benefits of joint mobilization for this condition. This case series is a preliminary investigation of safety, as well as immediate and short-term clinical benefits, associated with gentle knee and ankle joint mobilization in people with hemophilic arthropathy. A single intervention of joint mobilization was applied to the affected knees and/or ankles of 16 individuals with severe or moderate hemophilia within a public hospital setting. Adverse events, as well as immediate (pain-free passive joint range, Timed Up and Go Test with maximum pain numerical rating scale) and short-term (Lower Extremity Functional Scale) effects of the intervention were evaluated with a repeated measures ANOVA. There were no adverse events. An immediate significant increase was observed in pain-free passive ankle joint range of motion ( p  mobilization intervention. The findings of this case series suggest that gentle joint mobilization techniques may be safely considered as part of a multimodal management approach for hemophilic arthropathy.

  10. A four gene signature of chromosome instability (CIN4) predicts for benefit from taxanes in the NCIC-CTG MA21 clinical trial.

    Science.gov (United States)

    Spears, Melanie; Lyttle, Nicola; D'Costa, Alister; Chen, Bingshu E; Yao, Cindy Q; Boutros, Paul C; Burnell, Margot; Levine, Mark N; O'Brien, Patti; Shepherd, Lois; Bartlett, John M S

    2016-08-02

    Recent evidence demonstrated CIN4 as a predictive marker of anthracycline benefit in early breast cancer. An analysis of the NCIC CTG MA.21 clinical trial was performed to test the role of existing CIN gene expression signatures as prognostic and predictive markers in the context of taxane based chemotherapy.RNA was extracted from patients in cyclophosphamide, epirubicin and flurouracil (CEF) and epirubicin, cyclophosphamide and paclitaxel (EC/T) arms of the NCIC CTG MA.21 trial and analysed using NanoString technology.After multivariate analysis both high CIN25 and CIN70 score was significantly associated with an increased in RFS (HR 1.76, 95%CI 1.07-2.86, p=0.0018 and HR 1.59, 95%CI 1.12-2.25, p=0.0096 respectively). Patients whose tumours had low CIN4 gene expression scores were associated with an increase in RFS (HR: 0.64, 95% CI 0.39-1.03, p=0.06) when treated with EC/T compared to patients treated with CEF.In conclusion we have demonstrated CIN25 and CIN70 as prognostic markers in breast cancer and that CIN4 is a potential predictive maker of benefit from taxane treatment.

  11. A Multicenter, Prospective, Randomized Controlled Trial to Evaluate the Additional Benefit of a Multistrain Synbiotic (Prodefen® in the Clinical Management of Acute Viral Diarrhea in Children

    Directory of Open Access Journals (Sweden)

    Emilia García-Menor MD

    2016-11-01

    Full Text Available This randomized, open-label study evaluated the additional benefits of the synbiotic Prodefen® in the clinical management of acute diarrhea of suspected viral origin in children between 6 months and 12 years of age. Study outcomes included the duration of diarrhea, the recovery from diarrhea, and the tolerability and acceptance of the treatment. The proportion of patients without diarrhea over the study period was greater in the synbiotic group than in the control group at all study time points, showing a statistically significant difference on the fifth day (95% vs 79%, p < 0.001. The duration of diarrhea (median and interquartile range was reduced by 1 day in the synbiotic-treated patients (3 [2-5] vs 4 [3-5], p = 0.377. The tolerability of the treatment regimen, as evaluated by the parents, was significantly better in those receiving the synbiotic than in the control group. Overall, 96% of the parents of children receiving the synbiotic reported being satisfied to very satisfied with the treatment regimen. The results of this study indicate that the addition of the synbiotic Prodefen® is a well-tolerated and well-accepted approach that provides an additional benefit to the standard supportive therapy in the management of acute viral diarrhea in children.

  12. Evaluating the benefit of introducing medical clerks as transcriptionists to assist physicians in outpatient clinics: a quantitative analysis of medical records by counting characters.

    Science.gov (United States)

    Kasahara, Satoko; Yoshizaki, Kayoko; Yamashita, Teppei; Takeda, Hiroshi

    2013-01-01

    This study evaluates the effects of the medical clerks introduced to reduce physicians' workloads in outpatient clinics by assisting with their documentation processes (e.g., the production of electronic medical records (EMRs)). The volume of information written in narrative text in EMRs from 2007 (pre-introduction of medical clerks) to 2012 (post-introduction) was measured by counting Japanese characters. The total number of medical records for analysis was 1,577. The average number of characters in EMRs increased from before the introduction of medical clerks to afterwards regardless of the types of documents (subjective or objective data) or visits (first or second visits). We conclude that introducing medical clerks improves the quantity of outpatients' medical records and that such a character-counting method is useful for evaluating the benefit of the introduction of medical clerks to assist physicians.

  13. Economic and clinical benefits of radiofrequency ablation versus hysterectomy in patients suffering from menorrhagia: a retrospective analysis with German health claims data.

    Science.gov (United States)

    Kessel, Sebastian; Hucke, Juergen; Goergen, Christoph; Soeder, Ruediger; Roemer, Thomas

    2015-05-01

    To assess clinical and economic benefits of radiofrequency ablation (RFA) compared to hysterectomy when treating patients suffering from menorrhagia. Based on German health claims data, a retrospective, longitudinal, observational analysis was performed. Patients having continuously statutory health insurance coverage during the study and being coded for menorrhagia and a relevant treatment option were included in the analysis. The control group was created using propensity score matching. We discovered that using RFA generates cost savings of €1844 during the quarter of performance. As direct costs during a 2-year follow-up show similar levels in both groups, these initial savings can be preserved. This is partly because even if more patients in the RFA group were re-coded for menorrhagia after initial therapy, just a small proportion of these patients required another surgical intervention. RFA should more often be considered a relevant treatment option both from an economic and a medical point of view.

  14. Clinical evaluation of the Mapleson theoretical ideal fresh gas flow sequence at the start of low-flow anaesthesia with isoflurane, sevoflurane and desflurane.

    Science.gov (United States)

    Ip-Yam, P C; Goh, M H; Chan, Y H; Kong, C F

    2001-02-01

    Mapleson used a computer spreadsheet model to predict the theoretical ideal fresh gas flow sequence at the start of low-flow anaesthesia. The aim was to increase the end-expired partial pressure of inhalational agent (PE'an) to one minimum alveolar concentration (MAC) as quickly as practicable and then to keep it constant. Ninety adult patients undergoing elective tonsillectomy under general anaesthesia were randomly allocated to one of three groups (n = 30) to receive isoflurane, sevoflurane or desflurane in oxygen. Fresh gas flow and vaporiser settings as specified by Mapleson were followed in all cases except that the maximum setting for desflurane was 18% (2.7 MAC instead of 3 MAC). Recordings of PE'an were made at 1, 2, 3, 4, 5, 7, 10, 15 and 20 min. Mean values of PE'an exceeded 1 MAC by 2 min in all three groups and remained above this value throughout. Each group's PE'an measurements were divided by their respective 1-MAC value. A simple two-level model (with patients at level 2 and time at level 1), with measurements at 1 min excluded, showed that the fitted value at 2 min and the time-weighted mean for 2-20 min for PE'iso (1.042 [95% CI 0.980-1.104] and 1.044 [0.984-1.104], respectively) were not significantly different from its 1-MAC value, whereas those of the PE'sevo (1.169 [1.119-1.219] and 1.143 [1.119-1.219]) and PE'des (1.305 [1.261-1.349] and 1.140 [1.098-1.182]) were significantly higher than their respective 1-MAC values. The Mapleson concept of an initial high fresh gas flow and high vaporiser settings, followed first by reduced high fresh gas flow, as followed in this clinical study, results in PE'an values close to or slightly higher than predicted in the spreadsheet model.

  15. Comparable benefit of β-blocker therapy in heart failure across regions of the world: meta-analysis of randomized clinical trials.

    Science.gov (United States)

    Chatterjee, Saurav; Udell, Jacob A; Sardar, Partha; Lichstein, Edgar; Ryan, John J

    2014-08-01

    There is a concern about geographical region heterogeneity regarding clinical benefit of β-blocker (BB) therapy in heart failure with reduced ejection fraction (HFrEF). This study sought to compare benefits of BB use within randomized controlled trials (RCTs) that enrolled patients with HFrEF from North America (NA) compared with other regions of the world (ROW). We conducted a meta-analysis using MEDLINE, EMBASE, Cochrane Library, Web of Science, and Scopus (inceptions-December 2012) of BB RCTs stratified according to NA vs ROW. The primary end point was all-cause mortality and secondary end points were cardiovascular death, sudden death, death due to pump failure, and premature drug discontinuation. Summary odds ratios (ORs) and 95% confidence intervals (CIs) for each outcome were calculated with interaction terms for region. Two-sided P values were calculated with P analysis included 16 RCTs with 14,452 patients; 7 trials were conducted in NA and 9 trials in ROW with follow-up durations of 3-58 months. All-cause mortality was consistently reduced in NA (OR, 0.82; 95% CI, 0.71-0.96; P = 0.01) and ROW (OR, 0.76; 95% CI, 0.69-0.84; P < 0.001; P-interaction = 0.40). Overall and according to region, all secondary end points including premature drug discontinuation were also less with BB therapy (P-interactions all ≥ 0.10). For the regions represented in the included trials, there is no evidence to suggest that geographic region is a significant moderator of clinical outcomes with BB therapy in HFrEF patients. Copyright © 2014 Canadian Cardiovascular Society. Published by Elsevier Inc. All rights reserved.

  16. Net clinical benefit of rivaroxaban versus warfarin in Japanese patients with nonvalvular atrial fibrillation: a subgroup analysis of J-ROCKET AF.

    Science.gov (United States)

    Uchiyama, Shinichiro; Hori, Masatsugu; Matsumoto, Masayasu; Tanahashi, Norio; Momomura, Shin-Ichi; Goto, Shinya; Izumi, Tohru; Koretsune, Yukihiro; Kajikawa, Mariko; Kato, Masaharu; Ueda, Hitoshi; Iekushi, Kazuma; Yamanaka, Satoshi; Tajiri, Masahiro

    2014-01-01

    The risk factors that have been identified for bleeding events with rivaroxaban are predominantly the same as those predicting thromboembolic ones in patients with atrial fibrillation (AF). Our aim was to determine the net clinical benefit (NCB) from the results of the J-ROCKET AF trial, in which rivaroxaban was compared with warfarin in Japanese patients with AF. Two strategies were adopted to quantify the NCB. First, the NCB was calculated as the number of ischemic strokes avoided with anticoagulation minus the number of excess intracranial hemorrhage (ICH) with a weight of 1.5. Second, the composite end point of major bleeding events and secondary efficacy end points (stroke, noncentral nervous system systemic embolism, myocardial infarction and death) to ascertain the NCB were established. Subgroup analysis by CHADS2 score or creatinine clearance was also performed. The adjusted NCB, which was given a weight of 1.5 for ICH, was nominally significant in favor of rivaroxaban therapy (difference in incidence rate -2.13; 95% confidence interval [CI]: -.26 to -3.99). Furthermore, the event rate of the composite end point tended to be lower in patients treated with rivaroxaban than in those treated with warfarin (rivaroxaban: 4.97% per year, warfarin: 6.11% per year; difference in incidence rate: -1.14; 95% CI: -3.40 to 1.12). The event rate of the composite end point tended to be consistently low in patients treated with rivaroxaban in the subanalysis by CHADS2 score and renal function. Analysis of the NCB supports that rivaroxaban therapy provides clinical benefit for Japanese patients with AF. Copyright © 2014 National Stroke Association. Published by Elsevier Inc. All rights reserved.

  17. Net clinical benefit of dabigatran vs. warfarin in venous thromboembolism: analyses from RE-COVER(®), RE-COVER™ II, and RE-MEDY™.

    Science.gov (United States)

    Feuring, Martin; Schulman, Sam; Eriksson, Henry; Kakkar, Ajay J; Schellong, Sebastian; Hantel, Stefan; Schueler, Elke; Kreuzer, Jörg; Goldhaber, Samuel Z

    2017-05-01

    The direct oral anticoagulants, e.g., dabigatran etexilate (DE), are effective and well tolerated treatments for venous thromboembolism (VTE). Net clinical benefit (NCB) is a useful concept in weighing potential benefits against potential harm of comparator drugs. The NCB of DE vs. warfarin in VTE treatment was compared. Post-hoc analyses were performed on pooled data from the 6-month RE-COVER® and RE-COVER™ II trials, and data from the RE-MEDY™ trial (up to 36 months), to compare the NCB of DE (150 mg twice daily) and warfarin [target international normalized ratio (INR) 2.0-3.0]. Patients (≥18 years old) had symptomatic proximal deep vein thrombosis and/or pulmonary embolism. NCB was the composite of cardiovascular endpoints (non-fatal events of recurrent VTE, myocardial infarction, stroke or systemic embolism), all-cause death, and bleeding outcomes, all weighted equally. A broad definition of NCB included major bleeding events (MBE) and clinically relevant non-major bleeding events as bleeding outcomes, while a narrow definition included just MBE. The pooled dataset totalled 5107 patients from RE-COVER/RE-COVER II and 2856 patients from RE-MEDY. When NCB was narrowly defined, NCB was similar between DE and warfarin. When broadly defined, NCB was superior with DE vs. warfarin [RE-COVER/RE-COVER II, hazard ratio (HR) 0.80; 95% confidence interval (CI), 0.68-0.95 and RE-MEDY, HR 0.73; 95% CI 0.59-0.91]. These findings were unaffected by warfarin time in therapeutic range. The NCB of DE was similar or superior to warfarin, depending on the NCB definition used, regardless of the quality of INR control.

  18. A Comparative Effectiveness Trial of Alternate Formats for Presenting Benefits and Harms Information for Low-Value Screening Services: A Randomized Clinical Trial.

    Science.gov (United States)

    Sheridan, Stacey L; Sutkowi-Hemstreet, Anne; Barclay, Colleen; Brewer, Noel T; Dolor, Rowena J; Gizlice, Ziya; Lewis, Carmen L; Reuland, Daniel S; Golin, Carol E; Kistler, Christine E; Vu, Maihan; Harris, Russell

    2016-01-01

    Healthcare overuse, the delivery of low-value services, is increasingly recognized as a critical problem. However, little is known about the comparative effectiveness of alternate formats for presenting benefits and harms information to patients as a strategy to reduce overuse. To examine the effect of different benefits and harms presentations on patients' intentions to accept low-value or potentially low-value screening services (prostate cancer screening in men ages 50-69 years; osteoporosis screening in low-risk women ages 50-64 years; or colorectal cancer screening in men and women ages 76-85 years). Randomized clinical trial of 775 individuals eligible to receive information about any 1 of the 3 screening services and scheduled for a visit with their clinician. Participants were randomized to 1 of 4 intervention arms that differed in terms of presentation format: words, numbers, numbers plus narrative, and numbers plus framed presentation. The trial was conducted from September 2012 to June 2014 at 2 family medicine and 2 internal medicine practices affiliated with the Duke Primary Care Research Consortium. The data were analyzed between May and September of 2015. One-page evidence-based decision support sheets on each of the 3 screening services, with benefits and harms information presented in 1 of 4 formats: words, numbers, numbers plus narratives, or numbers plus a framed presentation. The primary outcome was change in intention to accept screening (on a response scale from 1 to 5). Our secondary outcomes included general and disease-specific knowledge, perceived risk and consequences of disease, screening attitudes, perceived net benefit of screening, values clarity, and self-efficacy for screening. We enrolled and randomly allocated 775 individuals, aged 50 to 85 years, to 1 of 4 intervention arms: 195 to words, 192 to numbers, 196 to narrative, and 192 to framed formats. Intentions to accept screening were high before the intervention and

  19. Romidepsin for the treatment of relapsed/refractory peripheral T cell lymphoma: prolonged stable disease provides clinical benefits for patients in the pivotal trial

    Directory of Open Access Journals (Sweden)

    Francine Foss

    2016-03-01

    Full Text Available Abstract Background Achievement of durable responses in patients with relapsed/refractory peripheral T cell lymphoma (PTCL is challenging with current therapies, and there are few data regarding the potential benefits of continuing treatment in patients with the best response of stable disease (SD. Histone deacetylase inhibitors are a novel class of drugs with activity in T cell malignancies. Romidepsin was approved by the US Food and Drug Administration for the treatment of relapsed/refractory PTCL based on a pivotal trial demonstrating an objective response rate of 25 % (33/130, including 15 % with confirmed/unconfirmed complete response and a median duration of response of 28 months. Our objective was to further study the clinical benefits of romidepsin in patients that had the best response of SD. Methods Patients with PTCL relapsed/refractory to ≥1 prior therapy were treated with the approved dose of 14 mg/m2 romidepsin on days 1, 8, and 15 of six 28-day cycles; patients with SD or response after cycle 6 were allowed to continue on study until progression. By protocol amendment, patients treated for ≥12 cycles could receive maintenance dosing twice per cycle; after cycle 24, dosing could be further reduced to once per cycle in those who had received maintenance dosing for ≥6 months. Results Of the 32 patients (25 % with the best response of SD, 22 had SD for ≥90 days (SD90; cycle 4 response assessment. The longest SD was >3 years in a patient who received maintenance dosing of 14 mg/m2 on days 1 and 15 beginning in cycle 13. Patients with the best response of SD90 or partial response achieved similar overall and progression-free survival. Prolonged dosing of romidepsin was well tolerated. Conclusions We concluded that patients who achieve SD may consider continuing treatment because the clinical benefits of romidepsin may extend beyond objective responses. Trial registration NCT00426764

  20. Benefits and Challenges of Supervising Physical Therapy Students in the State of Kuwait: A National Study.

    Science.gov (United States)

    Aljadi, Sameera H; Alotaibi, Naser M; Alrowayeh, Hesham N; Alshatti, Talal A

    2017-01-01

    One common component of allied health education is clinical fieldwork. It is the bridge between the didactic curriculum and clinical practice. Clinical supervisors perceive that being a clinical supervisor has both benefits and challenges. A modified questionnaire was distributed to 75 physical therapists who had previously or were currently engaged in supervising physical therapy students in 12 public hospitals in the State of Kuwait. In addition to demographic data, the questionnaire asked about the benefits and challenges associated with supervising students. The results indicated that the clinical fieldwork supervisors regarded their student supervision process as highly beneficial and reported that it improved their professionalism, problem-solving skills, and clinical reasoning. Challenges to supervision included students' lack of theoretical knowledge, poor hands-on skills, and poor writing/documentation skills. Suggestions are put forth to promote additional benefits and overcome existing challenges to develop a more successful physical therapy clinical education process for the supervisors and the students.

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

    Science.gov (United States)

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

    2014-07-01

    cellular 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. Copyright © 2014 Elsevier B.V. All rights reserved.

  2. Clinical characteristics predict benefits from eptifibatide therapy during coronary stenting: insights from the Enhanced Suppression of the Platelet IIb/IIIa Receptor With Integrilin Therapy (ESPRIT) trial.

    Science.gov (United States)

    Puma, Joseph A; Banko, Lesan T; Pieper, Karen S; Sacchi, Terrence J; O'Shea, J Conor; Dery, Jean Pierre; Tcheng, James E

    2006-02-21

    In order to determine a differential benefit from treatment, we compared the long-term outcome of high-risk versus low-risk patients and evaluated survival free from death or myocardial infarction at one year. Newer anticoagulant strategies during percutaneous coronary intervention have necessitated a reanalysis of the role of intravenous GP IIb/IIIa inhibitors. The Enhanced Suppression of the Platelet IIb/IIIa Receptor with Integrilin Therapy trial randomized 2,064 patients undergoing nonurgent coronary stent implantation to eptifibatide or placebo. High-risk characteristics were defined as age >75 years, diabetes, elevated cardiac markers, ST-segment elevation myocardial infarction within 7 days, or unstable angina within 48 h of randomization. Age <5 years, absence of diabetes, and any other reason for admission were considered low risk characterstics. There were 1,018 patients in the high-risk group (50.8% eptifibatide, 49.2% placebo) and 1,045 patients in the low-risk group (50.0% eptifibatide, 50.0% placebo). Baseline demographics were similar in both groups except for more hypertension (63% vs. 55%, respectively), peripheral vascular disease (8.2% vs. 5.2%, respectively), prior stroke (5.5% vs. 3.2%, respectively), and female gender (33% vs. 22%, respectively) in the high-risk than the low-risk group. At one year, the composite end point of death or myocardial infarction occurred in 15.89% of placebo patients and 7.99% of eptifibatide patients in the high-risk group and 9.02% of the placebo and 8.11% of eptifibatide patients in the low-risk group. Although eptifibatide treatment improved outcomes for all patients, preprocedural clinical characteristics can define a subgroup of patients who may derive greatest benefit from its use during coronary stent placement.

  3. QUALITY MANAGEMENT SYSTEM IN CLINICAL LABORATORIES ACCORDING TO THE ISO 15189:2007 STANDARD - EVALUATION OF THE BENEFITS OF IMPLEMENTATION IN AN ASSISTED REPRODUCTION LABORATORY

    Directory of Open Access Journals (Sweden)

    A.D. Sialakouma

    2011-03-01

    in the provision of human resources, equipment, supplies and working environment and the resolution of organisational problems. This article deals with the planning and the implementation of a Quality Management System, in accordance with ISO 15189 (2007, in the Assisted Reproduction Laboratory in one of the biggest Maternity Clinics in Greece. The benefits resulted; both for medical laboratory service and patients are also presented and discussed.

  4. Parental comprehension of the benefits/risks of first-line randomised clinical trials in children with solid tumours: a two-stage cross-sectional interview study

    Science.gov (United States)

    Chappuy, Hélène; Bouazza, Naim; Minard-Colin, Veronique; Patte, Catherine; Brugières, Laurence; Landman-Parker, Judith; Auvrignon, Anne; Davous, Dominique; Pacquement, Hélène; Orbach, Daniel; Tréluyer, Jean Marc; Doz, François

    2013-01-01

    Objectives To analyse the parental understanding of informed consent information in first-line randomised clinical trials (RCTs) including children with malignant solid tumours and to assess parents’ needs for decision-making. Design Observational prospective study. Setting 3 paediatric oncology centres in the Parisian region in France. Participants 53 parents were approached to participate in a RCT for their child with malignant solid tumour, over a 1-year period. 40 parents have been interviewed in our study. Primary and secondary outcome measures Parental understanding of information in RCTs, parents’ needs for decision-making. Parents were questioned by a psychologist, independent of the paediatric oncology teams, using a semidirected interview, 1 (M1) and 6 months (M6) after the consent was sought. Results 18 parents (45%) did not understand the concept of randomisation. Half of the parents could explain neither the aim of the clinical trial nor the potential benefit to their child of inclusion. 35 parents (87.5%) expressed very few specific risks related to the trial. Being mostly French-speaking (p=0.03) and the reading of the information sheet by the parents (p=0.0025) improved their understanding. The parental comprehension did not differ between M1 and M6. The principal factors underlying their decision were confidence in the medical team (39%), wish to access to the best treatment (37%) and the best quality of life (37%). Conclusions Despite medical explanations, parents have limited knowledge in some areas in first-line RCTs and improvements of information process are required. The risks specific to the randomised trial are underestimated by parents and the unproven nature of the treatment is not well-known or understood. PMID:23793670

  5. Identifying who will benefit from non-invasive ventilation in amyotrophic lateral sclerosis/motor neurone disease in a clinical cohort.

    Science.gov (United States)

    Berlowitz, David J; Howard, Mark E; Fiore, Julio F; Vander Hoorn, Stephen; O'Donoghue, Fergal J; Westlake, Justine; Smith, Anna; Beer, Fiona; Mathers, Susan; Talman, Paul

    2016-03-01

    Respiratory failure is associated with significant morbidity and is the predominant cause of death in motor neurone disease/amyotrophic lateral sclerosis (MND/ALS). This study aimed to determine the effect of non-invasive ventilatory (NIV) support on survival and pulmonary function decline across MND/ALS phenotypes. Cohort recruited via a specialist, multidisciplinary clinic. Patients were categorised into four clinical phenotypes (ALS, flail arm, flail leg and primary lateral sclerosis) according to site of presenting symptom and the pattern of upper versus lower motor neurone involvement. NIV was initiated according to current consensus practice guidelines. Between 1991 and 2011, 1198 patients diagnosed with ALS/MND were registered. 929 patients (77.5%) fulfilled the selection criteria and their data were analysed. Median tracheostomy free survival from symptom onset was 28 months in NIV-treated patients compared to 15 months in untreated (Univariate Cox regression HR=0.61 (0.51 to 0.73), p<0.001). The positive survival effect of NIV persisted when the model was adjusted for age, gender, riluzole and percutaneous endoscopic gastrostomy use (HR=0.72 (0.60 to 0.88, p=0.001). In contrast with the only randomised controlled trial, NIV statistically significantly increased survival by 19 months in those with ALS-bulbar onset (Univariate HR=0.50 (0.36 to 0.70), multivariate HR=0.59 (0.41 to 0.83)). These data confirm that NIV improves survival in MND/ALS. The overall magnitude of benefit is 13 months and was largest in those with ALS-bulbar disease. Future research should explore the optimal timing of NIV initiation within phenotypes in order to optimise respiratory function, quality of life and survival. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing/

  6. Assessing the clinical or pharmaco-economical benefit of target controlled desflurane delivery in surgical patients using the Zeus anaesthesia machine.

    Science.gov (United States)

    Lortat-Jacob, B; Billard, V; Buschke, W; Servin, F

    2009-11-01

    The Zeus anaesthesia machine includes an auto-control mode which allows targeting of end-tidal volatile and inspired oxygen concentrations. We assessed the clinical benefits and economic impact of this target-controlled anaesthesia compared with conventional manually controlled anaesthesia. Eighty patients were randomly assigned to receive desflurane either with a fresh gas flow set by the anaesthetist or in auto-control mode. Drug delivery was adjusted to maintain bispectral index between 40-60 units and systolic arterial pressure under 15 mmHg above its pre-induction value (upper limit) and over 90 mmHg (lower limit). Blood pressure was maintained in the desired range for 89% and 91% of the maintenance period for auto-control and manual control respectively (p = 0.49). Bispectral index was in the desired range for 82% and 79% of the maintenance period, for auto-control and manual control respectively (p = 0.46). Oxygen consumption was more than halved by the use of auto-control mode, and mean (SD) desflurane consumption during surgery was 0.07 (0.04) vs 0.2 (0.07) ml.min(-1) in auto-control and manual control respectively (p < 0.0001). The number of drug delivery adjustments per hour was significantly lower in auto-control mode (mean (SD) 7 (2) vs 15 (12); p < 0.0001). Thus, the auto-control mode provided similar haemodynamic stability and bispectral control as did conventional manually controlled anaesthesia, but led to a reduction in gas and vapour consumption with a more clinically acceptable workload.

  7. A randomized clinical trial of diabetes self-management for Mexican Americans: Are there serendipitous health benefits for supporters of study participants?

    Science.gov (United States)

    Brown, Sharon A; García, Alexandra A; Orlander, Philip R; Hanis, Craig L

    2017-01-01

    Studies of social support in diabetes have focused on the effects of support on the person with type 2 diabetes. We explored diabetes prevention effects of a culturally tailored diabetes self-management intervention in individuals without diabetes who were supporters of intervention participants. This is a secondary analysis of data from a randomized clinical trial that involved 256 Mexican Americans with diabetes. Each study participant designated a supporter-spouse, relative, friend-who attended intervention sessions and assisted participants in attaining effective diabetes self-management. Supporter's glycosylated hemoglobin (A1C) data were tracked for 1 year to determine diabetes conversion rates in supporters without diabetes at baseline. Fewer individuals in the intervention group (n = 9) converted to an A1C above the 7% threshold, compared to the 1-year wait-listed control group (n = 16). We found a statistically significant difference (p = .021) at 12 months in the number of individuals whose A1C was ⩽8%, with fewer supporters above threshold in the intervention group (reduction of 48%). Supporters in the intervention group with prediabetes, based on baseline A1C, experienced a slight reduction in A1C, while control group supporters with prediabetes experienced an increase. The results suggest that there are potential benefits for family members and other supporters of persons with diabetes who participated in diabetes self-management programs.

  8. A randomized clinical trial of diabetes self-management for Mexican Americans: Are there serendipitous health benefits for supporters of study participants?

    Directory of Open Access Journals (Sweden)

    Sharon A Brown

    2017-01-01

    Full Text Available Objectives: Studies of social support in diabetes have focused on the effects of support on the person with type 2 diabetes. We explored diabetes prevention effects of a culturally tailored diabetes self-management intervention in individuals without diabetes who were supporters of intervention participants. Methods: This is a secondary analysis of data from a randomized clinical trial that involved 256 Mexican Americans with diabetes. Each study participant designated a supporter—spouse, relative, friend—who attended intervention sessions and assisted participants in attaining effective diabetes self-management. Supporter’s glycosylated hemoglobin (A1C data were tracked for 1 year to determine diabetes conversion rates in supporters without diabetes at baseline. Results: Fewer individuals in the intervention group (n = 9 converted to an A1C above the 7% threshold, compared to the 1-year wait-listed control group (n = 16. We found a statistically significant difference (p = .021 at 12 months in the number of individuals whose A1C was ⩽8%, with fewer supporters above threshold in the intervention group (reduction of 48%. Supporters in the intervention group with prediabetes, based on baseline A1C, experienced a slight reduction in A1C, while control group supporters with prediabetes experienced an increase. Discussion: The results suggest that there are potential benefits for family members and other supporters of persons with diabetes who participated in diabetes self-management programs.

  9. American Society of Clinical Oncology Multidisciplinary Cancer Management Course: Connecting Lives, Cancer Care, Education, and Compassion in Zimbabwe-A Pilot for Efforts of Sustainable Benefit?

    Science.gov (United States)

    Ndarukwa, Sandra; Nyakabau, Anna Mary; Chagpar, Anees B; Raben, David; Ndlovu, Ntokozo; Kadzatsa, Webster; Eaton, Vanessa J; Mafunda, Paida; Razis, Evangelia

    2017-08-01

    The burden of cancer in low- to middle-income countries is growing and is expected to rise dramatically while resources to manage this disease remain inadequate. All authorities for the management of cancer recommend multidisciplinary care. Educational efforts by international organizations to assist local professionals in caring for their patients tend to have a lasting impact because they empower local professionals and enhance their skills. A multidisciplinary cancer management course was designed by American Society of Clinical Oncology staff and local experts to provide a roadmap for cross-specialty interaction and coordination of care in Zimbabwe. The outcome of the course was measured through feedback obtained from participants and impact on local workforce. The cancer management course was relevant to daily practice and fostered long-lasting partnerships and collaborations. Furthermore, it resulted in a more motivated local workforce and strengthened existing multidisciplinary practices. Cancer care is in a critical state in low- to middle-income countries. Educational efforts and collaborative partnerships may provide a cost-effective strategy with sustainable benefits. A multidisciplinary approach to optimize therapy is desirable. Evaluation of the course impact after a period of 6 months to 1 year is needed to determine the sustainability and impact of such efforts.

  10. Long-term Survival and Clinical Benefit from Adoptive T-cell Transfer in Stage IV Melanoma Patients Is Determined by a Four-Parameter Tumor Immune Signature.

    Science.gov (United States)

    Melief, Sara M; Visconti, Valeria V; Visser, Marten; van Diepen, Merel; Kapiteijn, Ellen H W; van den Berg, Joost H; Haanen, John B A G; Smit, Vincent T H B M; Oosting, Jan; van der Burg, Sjoerd H; Verdegaal, Els M E

    2017-02-01

    The presence of tumor-infiltrating immune cells is associated with longer survival and a better response to immunotherapy in early-stage melanoma, but a comprehensive study of the in situ immune microenvironment in stage IV melanoma has not been performed. We investigated the combined influence of a series of immune factors on survival and response to adoptive cell transfer (ACT) in stage IV melanoma patients. Metastases of 73 stage IV melanoma patients, 17 of which were treated with ACT, were studied with respect to the number and functional phenotype of lymphocytes and myeloid cells as well as for expression of galectins-1, -3, and -9. Single factors associated with better survival were identified using Kaplan-Meier curves and multivariate Cox regression analyses, and those factors were used for interaction analyses. The results were validated using The Cancer Genome Atlas database. We identified four parameters that were associated with a better survival: CD8(+) T cells, galectin-9(+) dendritic cells (DC)/DC-like macrophages, a high M1/M2 macrophage ratio, and the expression of galectin-3 by tumor cells. The presence of at least three of these parameters formed an independent positive prognostic factor for long-term survival. Patients displaying this four-parameter signature were found exclusively among patients responding to ACT and were the ones with sustained clinical benefit. Cancer Immunol Res; 5(2); 170-9. ©2017 AACR. ©2017 American Association for Cancer Research.

  11. Material Performance and Animal Clinical Studies on Performance-Optimized Hwangtoh Mixed Mortar and Concrete to Evaluate Their Mechanical Properties and Health Benefits

    Directory of Open Access Journals (Sweden)

    Bon-Min Koo

    2015-09-01

    Full Text Available In this study, the amount of cement used in a concrete mix is minimized to reduce the toxic effects on users by adjusting the concrete mixture contents. The reduction of cement is achieved by using various admixtures (ground granulated blast-furnace slag, flyash, ordinary Portland cement, and activated Hwangtoh powder. To apply the mix to construction, material property tests such as compressive strength, slump, and pH are performed. Preliminary experimental results showed that the Hwangtoh concrete could be used as a healthy construction material. Also, the health issues and effects of Hwangtoh mortar are quantitatively evaluated through an animal clinical test. Mice are placed in Hwangtoh mortar and cement mortar cages to record their activity. For the test, five cages are made with Hwangtoh and ordinary Portland cement mortar floors, using Hwangtoh powder replacement ratios of 20%, 40%, 60%, and 80% of the normal cement mortar mixing ratio, and two cages are made with Hwangtoh mortar living quarters. The activity parameter measurements included weight, food intake, water intake, residential space selection, breeding activity, and aggression. The study results can be used to evaluate the benefits of using Hwangtoh as a cement replacing admixture for lifestyle, health and sustainability.

  12. Material Performance and Animal Clinical Studies on Performance-Optimized Hwangtoh Mixed Mortar and Concrete to Evaluate Their Mechanical Properties and Health Benefits.

    Science.gov (United States)

    Koo, Bon-Min; Kim, Jang-Ho Jay; Kim, Tae-Kyun; Kim, Byung-Yun

    2015-09-17

    In this study, the amount of cement used in a concrete mix is minimized to reduce the toxic effects on users by adjusting the concrete mixture contents. The reduction of cement is achieved by using various admixtures (ground granulated blast-furnace slag, flyash, ordinary Portland cement, and activated Hwangtoh powder). To apply the mix to construction, material property tests such as compressive strength, slump, and pH are performed. Preliminary experimental results showed that the Hwangtoh concrete could be used as a healthy construction material. Also, the health issues and effects of Hwangtoh mortar are quantitatively evaluated through an animal clinical test. Mice are placed in Hwangtoh mortar and cement mortar cages to record their activity. For the test, five cages are made with Hwangtoh and ordinary Portland cement mortar floors, using Hwangtoh powder replacement ratios of 20%, 40%, 60%, and 80% of the normal cement mortar mixing ratio, and two cages are made with Hwangtoh mortar living quarters. The activity parameter measurements included weight, food intake, water intake, residential space selection, breeding activity, and aggression. The study results can be used to evaluate the benefits of using Hwangtoh as a cement replacing admixture for lifestyle, health and sustainability.

  13. Case study and case-based research in emergency nursing and care: Theoretical foundations and practical application in paramedic pre-hospital clinical judgment and decision-making of patients with mental illness.

    Science.gov (United States)

    Shaban, Ramon Z; Considine, Julie; Fry, Margaret; Curtis, Kate

    2017-02-01

    Generating knowledge through quality research is fundamental to the advancement of professional practice in emergency nursing and care. There are multiple paradigms, designs and methods available to researchers to respond to challenges in clinical practice. Systematic reviews, randomised control trials and other forms of experimental research are deemed the gold standard of evidence, but there are comparatively few such trials in emergency care. In some instances it is not possible or appropriate to undertake experimental research. When exploring new or emerging problems where there is limited evidence available, non-experimental methods are required and appropriate. This paper provides the theoretical foundations and an exemplar of the use of case study and case-based research to explore a new and emerging problem in the context of emergency care. It examines pre-hospital clinical judgement and decision-making of mental illness by paramedics. Using an exemplar the paper explores the theoretical foundations and conceptual frameworks of case study, it explains how cases are defined and the role researcher in this form of inquiry, it details important principles and the procedures for data gathering and analysis, and it demonstrates techniques to enhance trustworthiness and credibility of the research. Moreover, it provides theoretically and practical insights into using case study in emergency care. Copyright © 2017 College of Emergency Nursing Australasia. Published by Elsevier Ltd. All rights reserved.

  14. Socioeconomic benefits

    African Journals Online (AJOL)

    User

    Coffea Arabica is extensively cultivated by households under a variety of shade trees in southwestern Ethiopia. The main purpose of this study was to assess the overall farmers' perception on the benefits of shade trees in coffee production systems in southwestern part of Ethiopia. Semistructured questionnaires were ...

  15. Employees' motivation and emloyees' benefits

    OpenAIRE

    Nedzelská, Eva

    2014-01-01

    The subject of this bachelor thesis is analysing methods how to stimulate and motivate employees. The theoretical part of the thesis deals with the concept of motivation, concepts close to motivation and selected existing theories of motivation. It also deals with employee benefits, function, division and benefits which are frequently offered to employees. The practical part of the thesis, mainly based on written and online questionnaires, concentrates on motivation of employees at Nedcon Boh...

  16. Methylphenidate treatment of attention deficit hyperactivity disorder in young people with learning disability and difficult-to-treat epilepsy: Evidence of clinical benefit

    Science.gov (United States)

    Fosi, Tangunu; Lax-Pericall, Maria T; Scott, Rod C; Neville, Brian G; Aylett, Sarah E

    2013-01-01

    Purpose To establish the efficacy and safety of methylphenidate (MPH) treatment for attention deficit hyperactivity disorder (ADHD) in a group of children and young people with learning disability and severe epilepsy. Methods This retrospective study systematically reviewed the case notes of all patients treated with methylphenidate (MPH) for Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV) ADHD at a specialist epilepsy center between 1998 and 2005. Treatment efficacy was ascertained using clinical global impressions (CGI) scores, and safety was indexed by instances of >25% increase in monthly seizure count within 3 months of starting MPH. Key Findings Eighteen (18) patients were identified with refractory epilepsies (14 generalized, 4 focal), IQ <70, and ADHD. Male patients predominated (13:5) and ADHD was diagnosed at a median age of 11.5 years (range 6–18 years). With use of a combination of a behavioral management program and MPH 0.3–1 mg/kg/day, ADHD symptoms improved in 61% of patients (11/18; type A intraclass correlation coefficient of CGI 0.85, 95% confidence interval [CI] 0.69–0.94). Daily MPH dose, epilepsy variables, and psychiatric comorbidity did not relate to treatment response across the sample. MPH adverse effects led to treatment cessation in three patients (dysphoria in two, anxiety in one). There was no statistical evidence for a deterioration of seizure control in this group with the use of MPH. Significance Methylphenidate with behavioral management was associated with benefit in the management of ADHD in more than half of a group of children with severe epilepsy and additional cognitive impairments. Eighteen percent had significant side effects but no attributable increase in seizures. Methylphenidate is useful in this group and is likely to be under employed. PMID:24304474

  17. Clinical benefit of the FIFA 11 programme for the prevention of hamstring and lateral ankle ligament injuries among amateur soccer players.

    Science.gov (United States)

    Nouni-Garcia, Rauf; Carratala-Munuera, Concepcion; Orozco-Beltran, Domingo; Lopez-Pineda, Adriana; Asensio-Garcia, María Rosario; Gil-Guillen, Vicente F

    2017-06-22

    To analyse the relationship between the implementation of 'the 11' protocol during the regular season in a men's amateur soccer team and the rate of hamstring and lateral ankle ligament (LAL) injuries, and to estimate the clinical benefit of the programme according to the type of injury and the position field. This cohort study was conducted in two different men's amateur soccer teams. During two seasons, the exposed group (43 players) performed 'the 11' protocol twice a week, and the unexposed group (43 players) performed the regular training programme. All players trained three times per week for 1.5 hours per day. Data collection was performed for every 1000 hours of play. 18 hamstring injuries (injury rate (IR) of 2.26 injuries/1000 training+competition hours) and 15 LAL injuries (IR of 1.88 injuries/1000) were registered in the exposed group. In the unexposed group, there were 25 LAL injuries (IR of 3.14 injuries/1000) and 35 hamstring injuries (IR of 4.39 injuries/1000). The number needed to treat to prevent one new case was 3.9 in LAL injuries, 3.31 in biceps femoris injuries and 10.7 in recurrent hamstring injuries. 'The 11' programme reduced the incidence of hamstring and LAL injuries in amateur players. According to the field position, the programme was effective for defenders and midfielders. In accordance with the type of injury, the exposed group had a lower risk of LAL, biceps femoris and hamstring injuries compared with those in the unexposed group. © Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2017. All rights reserved. No commercial use is permitted unless otherwise expressly granted.

  18. 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

    Directory of Open Access Journals (Sweden)

    Bischoff-Everding C

    2016-01-01

    Full Text Available Christoph Bischoff-Everding,1 Ruediger Soeder,2 Benno Neukirch3 1HGC GesundheitsConsult GmbH, Duesseldorf, Germany; 2Gynecological Joint Practice, Mainz, Germany; 3Faculty of Health Care, Hochschule Niederrhein – University of Applied Sciences, Krefeld, Germany 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

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

    Science.gov (United States)

    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

  20. Making benefit transfers work

    DEFF Research Database (Denmark)

    Bateman, I. J.; Brouwer, R.; Ferrini, S.

    2011-01-01

    We develop and test guidance principles for benefits transfers. These argue that when transferring across relatively similar sites, simple mean value transfers are to be preferred but that when sites are relatively dissimilar then value function transfers will yield lower errors. The paper also...... provides guidance on the appropriate specification of transferable value functions arguing that these should be developed from theoretical rather than ad-hoc statistical principles. These principles are tested via a common format valuation study of water quality improvements across five countries. Results...

  1. Making benefit transfers work

    DEFF Research Database (Denmark)

    Bateman, I.J.; Brouwer, R.; Ferrini, S.

    We develop and test guidance principles for benefits transfers. These argue that when transferring across relatively similar sites, simple mean value transfers are to be preferred but that when sites are relatively dissimilar then value function transfers will yield lower errors. The paper also...... provides guidance on the appropriate specification of transferable value functions arguing that these should be developed from theoretical rather than ad-hoc statistical principles. These principles are tested via a common format valuation study of water quality improvements across five countries. Results...

  2. SOME THEORETICAL ASPECTS OF COMPLEX CLINICAL-PSYCHOLOGICAL INVESTIGATION OF PATIENTS WITH AUTOIMMUNE LIVER DISEASES IN CIRRHOTIC STAGE BEFORE LIVER TRANSPLANTATION

    Directory of Open Access Journals (Sweden)

    O. A. Gerasimova

    2010-01-01

    Full Text Available This article presents preliminary results of complex clinical-psychological investigation of patients with autoim- mune liver diseases with cirrhosis waiting for liver transplant. The data discussed defense role of anxiety com- bined with other emotional affective disorders, psychological mechanisms in combination with coping strategies of stress-overcoming behavior in the state of disease and their involvement in formation of the clinical picture of the disease. It considers the need for differential diagnosis of the pathology using modern experimental- psychological methods in connection with further building of psychological aid to patients with autoimmune liver diseases. 

  3. Scientific imperatives, clinical implications, and theoretical underpinnings for the investigation of the relationship between genetic variables and patient-reported quality-of-life outcomes

    NARCIS (Netherlands)

    Sprangers, M.A.G.; Sloan, J.A.; Barsevick, A.; Chauhan, C.; Dueck, A.C.; Raat, H.; Shi, Q.; van Noorden, C.J.F.

    2010-01-01

    Objectives There is emerging evidence for a genetic basis of patient-reported quality-of-life (QOL) outcomes that can ultimately be incorporated into clinical research and practice. Objectives are (1) to provide arguments for the timeliness of investigating the genetic basis of QOL given the

  4. Clinical Trials

    Medline Plus

    Full Text Available ... harm. In later phases of clinical trials, researchers learn more about the new approach's risks and benefits. ... Clinical Studies Web page. Children and Clinical Studies Learn more about Children and Clinical Studies Importance of ...

  5. Concept and benefits of the Inverted Classroom method for a competency-based biochemistry course in the pre-clinical stage of a human medicine course of studies.

    Science.gov (United States)

    Kühl, Susanne J; Toberer, Matthias; Keis, Oliver; Tolks, Daniel; Fischer, Martin R; Kühl, Michael

    2017-01-01

    Background: Medical students often have a problem recognising the relevance of basic science subjects for their later professional work in the pre-clinical stage of their studies. This can lead to a lower motivation to learn biochemical content and dissatisfaction in the courses amongst the students. Alternative teaching methods such as the Inverted Classroom (IC) method can address this deficiency. The goal of this study was: to analyse the motivation and satisfaction of the students in a biochemistry seminar through the use of the e-learning-based IC method, to investigate the acceptance against the IC teaching method in biochemistry, and to compare the learning success achieved using the IC approach with that of a traditional course. We also investigated how a biochemistry course in the pre-clinical stage of a human medicine course of studies can be successfully organised according to the IC method. Furthermore, we examined the benefits of the IC method over conventional teaching formats. Method: The IC method was implemented in accordance with the guidelines of the GMA committee "New Media" [30] in a biochemistry seminar for two student IC intervention groups with 42 students. A part of the factual knowledge from the on-site phase in the form of teaching videos together with self-learning control tasks were provided online before the seminar for both IC intervention groups. Exporting content to the self-learning phase creates new free time in the on-site phase, during which the content can be critically considered and processed and additional competency-based learning objectives can be taught. Identical biochemistry teaching content was taught in parallel control groups (14 student groups with n=299 students), but no material was handed out beforehand for a self-learning phase. These students only received the materials after the on-site phase. Motivation and satisfaction as well as the acceptance for the teaching methods were recorded by questionnaires, the

  6. Concept and benefits of the Inverted Classroom method for a competency-based biochemistry course in the pre-clinical stage of a human medicine course of studies

    Directory of Open Access Journals (Sweden)

    Kühl, Susanne J.

    2017-08-01

    Full Text Available Background: Medical students often have a problem recognising the relevance of basic science subjects for their later professional work in the pre-clinical stage of their studies. This can lead to a lower motivation to learn biochemical content and dissatisfaction in the courses amongst the students. Alternative teaching methods such as the Inverted Classroom (IC method can address this deficiency. The goal of this study was: We also investigated how a biochemistry course in the pre-clinical stage of a human medicine course of studies can be successfully organised according to the IC method. Furthermore, we examined the benefits of the IC method over conventional teaching formats. Method: The IC method was implemented in accordance with the guidelines of the GMA committee “New Media” in a biochemistry seminar for two student IC intervention groups with 42 students. A part of the factual knowledge from the on-site phase in the form of teaching videos together with self-learning control tasks were provided online before the seminar for both IC intervention groups. Exporting content to the self-learning phase creates new free time in the on-site phase, during which the content can be critically considered and processed and additional competency-based learning objectives can be taught. Identical biochemistry teaching content was taught in parallel control groups (14 student groups with n=299 students, but no material was handed out beforehand for a self-learning phase. These students only received the materials after the on-site phase. Motivation and satisfaction as well as the acceptance for the teaching methods were recorded by questionnaires, the acquisition of knowledge by MC exams.Results: On a Likert scale from 1 (strongly disagree to 6 (strongly agree, the students in the IC intervention groups could be seen to be much more motivated (5.53 than students in the control group (4.01. Students in the IC intervention groups also recognised the

  7. Concept and benefits of the Inverted Classroom method for a competency-based biochemistry course in the pre-clinical stage of a human medicine course of studies

    Science.gov (United States)

    Kühl, Susanne J.; Toberer, Matthias; Keis, Oliver; Tolks, Daniel; Fischer, Martin R.; Kühl, Michael

    2017-01-01

    Background: Medical students often have a problem recognising the relevance of basic science subjects for their later professional work in the pre-clinical stage of their studies. This can lead to a lower motivation to learn biochemical content and dissatisfaction in the courses amongst the students. Alternative teaching methods such as the Inverted Classroom (IC) method can address this deficiency. The goal of this study was: to analyse the motivation and satisfaction of the students in a biochemistry seminar through the use of the e-learning-based IC method, to investigate the acceptance against the IC teaching method in biochemistry, and to compare the learning success achieved using the IC approach with that of a traditional course. We also investigated how a biochemistry course in the pre-clinical stage of a human medicine course of studies can be successfully organised according to the IC method. Furthermore, we examined the benefits of the IC method over conventional teaching formats. Method: The IC method was implemented in accordance with the guidelines of the GMA committee “New Media” [30] in a biochemistry seminar for two student IC intervention groups with 42 students. A part of the factual knowledge from the on-site phase in the form of teaching videos together with self-learning control tasks were provided online before the seminar for both IC intervention groups. Exporting content to the self-learning phase creates new free time in the on-site phase, during which the content can be critically considered and processed and additional competency-based learning objectives can be taught. Identical biochemistry teaching content was taught in parallel control groups (14 student groups with n=299 students), but no material was handed out beforehand for a self-learning phase. These students only received the materials after the on-site phase. Motivation and satisfaction as well as the acceptance for the teaching methods were recorded by questionnaires

  8. Separate spheres and indirect benefits

    Directory of Open Access Journals (Sweden)

    Brock Dan W

    2003-02-01

    Full Text Available Abstract 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.

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

    Energy Technology Data Exchange (ETDEWEB)

    Wu, J; Hill, G; Spiegel, J [Swedish Cancer Institute, Issaquah, Washington (United States); Ye, J [Swedish Cancer Institute, Edmond, Washington (United States); Mehta, V [Swedish Cancer Institute, Seattle, WA (United States)

    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.

  10. Clinical and Demographic Profile of Patients Receiving Fingolimod in Clinical Practice in Germany and the Benefit-Risk Profile of Fingolimod After 1 Year of Treatment: Initial Results From the Observational, Noninterventional Study PANGAEA.

    Science.gov (United States)

    Ziemssen, Tjalf; Lang, Michael; Tackenberg, Björn; Schmidt, Stephan; Albrecht, Holger; Klotz, Luisa; Haas, Judith; Lassek, Christoph; Medin, Jennie; Cornelissen, Christian

    2017-12-22

    The population with multiple sclerosis receiving treatment in clinical practice differs from that in randomized controlled trials (RCTs). An assessment of the real-world benefit-risk profile of therapies is needed. This analysis used data from the large, noninterventional, observational German study Post-Authorization Non-interventional German sAfety study of GilEnyA (PANGAEA) to assess prospectively baseline characteristics and outcomes after 12 months (± 90 days) of fingolimod treatment. Patients were divided into 2 cohorts: fingolimod starter [first received fingolimod in PANGAEA (n = 3315)] and previous study [received fingolimod before enrollment in PANGAEA in RCTs (n = 875), some of whom also had baseline data at entry into RCTs (n = 505)]. At PANGAEA baseline, patients in the fingolimod starter versus the previous study cohort had a higher annualized relapse rate [ARR (95% confidence interval): 1.79 (1.75-1.83) vs 1.32 (1.25-1.40)] and Expanded Disability Status Scale score [3.11 (3.04-3.17) vs 2.55 (2.44-2.66)]. A greater proportion in the fingolimod starter versus previous study cohort had diabetes (2.0% vs 0.7%). After 12 months of fingolimod, ARRs were lower than in the 12 months before PANGAEA enrollment in the fingolimod starter [0.386 (0.360-0.414)] and previous study [0.276 (0.238-0.320)] cohorts. Expanded Disability Status Scale scores were stable versus baseline. Adverse events were experienced by similar proportions in both cohorts during fingolimod treatment. Relevant differences exist in disease activity and comorbidities between patients receiving fingolimod in clinical practice versus RCTs. Irrespective of baseline differences indicating a higher proportion at an advanced stage of multiple sclerosis in the real world versus RCTs, fingolimod remains effective, with a manageable safety profile.

  11. Who benefits?

    DEFF Research Database (Denmark)

    Hjorth, Frederik Georg

    2016-01-01

    Cross-border welfare rights for citizens of European Union member states are intensely contested, yet there is limited research into voter opposition to such rights, sometimes denoted ‘welfare chauvinism’. We highlight an overlooked aspect in scholarly work: the role of stereotypes about...... beneficiaries of cross-border welfare. We present results from an original large-scale survey experiment (N=2525) among Swedish voters, randomizing exposure to cues about recipients' country of origin and family size. Consistent with a model emphasizing the role of stereotypes, respondents react to cues about...... recipient identity. These effects are strongest among respondents high in ethnic prejudice and economic conservatism. The findings imply that stereotypes about who benefits from cross-border welfare rights condition public support for those rights....

  12. Benign and malignant cartilage tumors of bone and joint: their anatomic and theoretical basis with an emphasis on radiology, pathology and clinical biology. II. Juxtacortical cartilage tumors

    Energy Technology Data Exchange (ETDEWEB)

    Brien, E.W. [Orthopaedic Oncology Service, Orthopaedic Hospital, Los Angeles, CA (United States)]|[Musculoskeletal Tumor Service, Orthopaedic Hospital, Los Angeles, CA (United States); Mirra, J.M.; Luck, J.V. Jr. [Orthopaedic Oncology Service, Orthopaedic Hospital, Los Angeles, CA (United States)

    1999-01-01

    In part I, we reviewed the varied clinical presentations, pathogenesis, histologic findings, radiologic findings, and treatment of intramedullary cartilaginous lesions of bone. In this section, we will evaluate our cases and consultations of juxtacortical cartilaginous tumors. Radiographic differential diagnosis includes the numerous juxtacortical lesions particularly osteochondroma, parosteal chondroma, Trevor`s disease, trauma (fracture and periostitis ossificans), and the low- and high-grade surface osteosarcomas. By emphasizing pathogenesis in conjunction with radiographic and histologic findings, pitfalls in diagnosis and subsequent treatment can be avoided in such cases. (orig.) With 32 figs., 2 tabs., 32 refs.

  13. Clinical and theoretical issues in self-injurious behavior Questões teórico-clínicas do comportamento de automutilação

    Directory of Open Access Journals (Sweden)

    Jose A. Yaryura-Tobias

    1999-09-01

    Full Text Available This article presents an overview of pathological self-injurious behavior (SIB. Historical and cultural aspects, epidemiology, classification and clinical aspects and pathogenesis are described. The importance of comprehensive assessment of symptomatology and functions of SIB for treatment planning are discussed.O presente artigo apresenta um panorama do comportamento de automutilação patológica. São descritos aspectos históricos e culturais, epidemiologia, classificação e aspectos clínicos e patogênese. É discutida ainda a importância de uma avaliação compreensiva da sintomatologia e das funções do comportamento para fins de tratamento.

  14. Reabilitação vestibular: utilidade clínica em pacientes com esclerose múltipla Vestibular rehabilitation: clinical benefits to patients with multiple sclerosis

    Directory of Open Access Journals (Sweden)

    Bianca Simone Zeigelboim

    2010-01-01

    Full Text Available O objetivo desse estudo foi analisar a eficácia do exercício de reabilitação vestibular em dois casos de esclerose múltipla remitente-recorrente. Ambos os casos foram encaminhados do Hospital de Clínicas para o Laboratório de Otoneurologia de uma instituição de ensino e foram submetidos aos seguintes procedimentos: anamnese, inspeção otológica, avaliação vestibular e aplicação do Dizziness Handicap Inventory pré e pós reabilitação vestibular utilizando-se o protocolo de Cawthorne e Cooksey. No primeiro caso, gênero feminino, 35 anos, tempo de doença de seis anos, referiu tontura há três anos, de intensidade moderada de ocorrência frequente, cefaléia, quedas, desvio de marcha à direita e sensação de desmaio (sic. Apresentou no exame labiríntico, síndrome vestibular periférica deficitária bilateral. No segundo caso, gênero feminino, 49 anos, tempo de doença de dois anos, referiu desvio de marcha à direita, dificuldade e/ou dor ao movimento do pescoço, formigamento de extremidade e alteração vocal. Apresentou no exame labiríntico, síndrome vestibular periférica deficitária à direita. Houve melhora significativa em ambos os casos dos aspectos físico, funcional e emocional do Dizziness Handicap Inventory após a realização da reabilitação vestibular. O protocolo utilizado promoveu melhora na qualidade de vida e auxiliou no processo de compensação vestibular.The aim of the present study was to analyze the effectiveness of vestibular rehabilitation exercises in two cases of remittent-recurrent multiple sclerosis. Both cases were referred from the Clinics Hospital to the Laboratory of Otoneurology of the same institution and were submitted to the following procedures: anamnesis, otological inspection, vestibular evaluation, and application of the Dizziness Handicap Inventory before and after vestibular rehabilitation using the Cawthorne and Cooksey protocol. The first case was a 35-year-old female

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

    Directory of Open Access Journals (Sweden)

    Uusitalo H

    2016-03-01

    Full Text Available Hannu Uusitalo,1 Evgeniy Egorov,2 Kai Kaarniranta,3 Yuri Astakhov,4 Auli Ropo5 On behalf of the Switch Study Tafluprost Study Groups 1Department of Ophthalmology, SILK, University of Tampere, Tampere University Hospital, Tampere, Finland; 2Department of Ophthalmology, The Russian National Research Medical University, Moscow, Russia; 3Department of Ophthalmology, University of Eastern Finland, Kuopio University Hospital, Kuopio, Finland, 4Department of Ophthalmology, First Pavlov State Medical University of St Petersburg, Saint Petersburg, Russia, 5Global Medical Affairs, Santen Oy, Tampere, Finland 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

  16. Music Therapy for Posttraumatic Stress in Adults: A Theoretical Review.

    Science.gov (United States)

    Landis-Shack, Nora; Heinz, Adrienne J; Bonn-Miller, Marcel O

    2017-01-01

    Music therapy has been employed as a therapeutic intervention to facilitate healing across a variety of clinical populations. There is theoretical and empirical evidence to suggest that individuals with trauma exposure and Posttraumatic Stress Disorder (PTSD), a condition characterized by enduring symptoms of distressing memory intrusions, avoidance, emotional disturbance, and hyperarousal, may derive benefits from music therapy. The current narrative review describes the practice of music therapy and presents a theoretically-informed assessment and model of music therapy as a tool for addressing symptoms of PTSD. The review also presents key empirical studies that support the theoretical assessment. Social, cognitive, and neurobiological mechanisms (e.g., community building, emotion regulation, increased pleasure, anxiety reduction) that promote music therapy's efficacy as an adjunctive treatment for individuals with posttraumatic stress are discussed. It is concluded that music therapy may be a useful therapeutic tool to reduce symptoms and improve functioning among individuals with trauma exposure and PTSD, though more rigorous empirical study is required. In addition, music therapy may help foster resilience and engage individuals who struggle with stigma associated with seeking professional help. Practical recommendations for incorporating music therapy into clinical practice are offered along with several suggestions for future research.

  17. Music Therapy for Posttraumatic Stress in Adults: A Theoretical Review

    Science.gov (United States)

    Landis-Shack, Nora; Heinz, Adrienne J.; Bonn-Miller, Marcel O.

    2017-01-01

    Music therapy has been employed as a therapeutic intervention to facilitate healing across a variety of clinical populations. There is theoretical and empirical evidence to suggest that individuals with trauma exposure and Posttraumatic Stress Disorder (PTSD), a condition characterized by enduring symptoms of distressing memory intrusions, avoidance, emotional disturbance, and hyperarousal, may derive benefits from music therapy. The current narrative review describes the practice of music therapy and presents a theoretically-informed assessment and model of music therapy as a tool for addressing symptoms of PTSD. The review also presents key empirical studies that support the theoretical assessment. Social, cognitive, and neurobiological mechanisms (e.g., community building, emotion regulation, increased pleasure, anxiety reduction) that promote music therapy’s efficacy as an adjunctive treatment for individuals with posttraumatic stress are discussed. It is concluded that music therapy may be a useful therapeutic tool to reduce symptoms and improve functioning among individuals with trauma exposure and PTSD, though more rigorous empirical study is required. In addition, music therapy may help foster resilience and engage individuals who struggle with stigma associated with seeking professional help. Practical recommendations for incorporating music therapy into clinical practice are offered along with several suggestions for future research. PMID:29290641

  18. [Early termination of the multicentre randomised clinical trial to evaluate the benefit of testing for thrombophilia following a first venous thromboembolism: the NOSTRADAMUS study].

    Science.gov (United States)

    Cohn, D M; Middeldorp, S

    2008-09-20

    The NOSTRADAMUS study (ISRCTN07836779) was prematurely terminated due to low inclusion rates. There were several causes for this low inclusion: delay of approval by medical ethics committees, competition with industry-initiated intervention studies with a higher financial compensation, and the lack of study staff and allowance of expenses. We advise restraint with respect to testing for thrombophilia in patients with a first deep vein thrombosis or pulmonary embolism, as the benefit of this procedure has yet to be demonstrated.

  19. The European Society for Medical Oncology 'Magnitude of Clinical Benefit Scale' field-tested in infrequent tumour entities: an extended analysis of its feasibility at the Medical University of Vienna.

    Science.gov (United States)

    Kiesewetter, Barbara; Raderer, Markus; Prager, Gerald W; Fuereder, Thorsten; Marosi, Christine; Preusser, Matthias; Krainer, Michael; Locker, Gottfried J; Brodowicz, Thomas; Zielinski, Christoph C

    2017-01-01

    The European Society for Medical Oncology Magnitude of Clinical Benefit Scale (ESMO-MCBS) is a new tool to quantify the clinical benefit that may be anticipated from a novel anticancer treatment. We present here an analysis on the feasibility of the ESMO-MCBS in less frequent tumour entities. This study evaluates the practicability of the ESMO-MCBS for metastatic neuroendocrine tumours (NETs), soft tissue sarcomas, glioblastoma, thyroid cancer, pancreatic cancer, head/neck cancer, urothelial cancer and ovarian cancer at the Medical University Vienna. A three-step approach including data acquisition, assessment of ESMO-MCBS scores and evaluation of results with a focus on clinical feasibility was applied. In NET and thyroid cancer, all analysed trials were very comparable in design and efficacy, and the ESMO-MCBS scores appeared to be consistent with the clinical benefit seen in practice. For pancreatic cancer, it was more difficult to compare first-line trials due to diverging populations included in the respective studies. Concerning soft tissue sarcomas, the ESMO-MCBS was applicable for gastrointestinal stromal tumours(GIST) and 'non-GIST' soft tissue sarcoma with respect to data deriving from randomised studies. However, due to the heterogeneity of the disease itself and a limited number of controlled trials, limitations are noted. In ovarian cancer, the ESMO-MCBS supported the use of bevacizumab in high-risk patients. To date, there are only limited data for glioblastoma, head/neck cancer and urothelial cancer but whenever randomised trials were available, the ESMO-MCBS rating supported clinical decisions. Interestingly, nivolumab for salvage treatment of head/neck cancer rated extremely high. The ESMO-MCBS scores supported our common treatment strategies and highlight the potential of new immunomodulatory drugs. Our results encourage further development of the ESMO-MCBS.

  20. Prospective cost-benefit analysis of a two-dimensional barcode for vaccine production, clinical documentation, and public health reporting and tracking.

    Science.gov (United States)

    O'Connor, Alan C; Kennedy, Erin D; Loomis, Ross J; Haque, Saira N; Layton, Christine M; Williams, Warren W; Amoozegar, Jacqueline B; Braun, Fern M; Honeycutt, Amanda A; Weinbaum, Cindy

    2013-06-28

    In the United States recording accurate vaccine lot numbers in immunization records is required by the National Childhood Vaccine Injury Act and is necessary for public health surveillance and implementation of vaccine product recalls. However, this information is often missing or inaccurate in records. The Food and Drug Administration (FDA) requires a linear barcode of the National Drug Code (NDC) on vaccine product labels as a medication verification measure, but lot number and expiration date must still be recorded by hand. Beginning in 2011, FDA permitted manufacturers to replace linear barcodes with two-dimensional (2D) barcodes on unit-of-use product labels. A 2D barcode can contain the NDC, expiration date, and lot number in a symbol small enough to fit on a unit-of-use label. All three data elements could be scanned into a patient record. To assess 2D barcodes' potential impacts, a mixed-methods approach of time-motion data analysis, interview and survey data collection, and cost-benefit analysis was employed. Analysis of a time-motion study conducted at 33 practices suggests scanning 2D-barcoded vaccines could reduce immunization documentation time by 36-39 s per dose. Data from an internet survey of primary care providers and local health officials indicate that 60% of pediatric practices, 54% of family medicine practices, and 39% of health departments would use the 2D barcode, with more indicating they would do so if they used electronic health records. Inclusive of manufacturer and immunization provider costs and benefits, we forecast lower-bound net benefits to be $310-334 million between 2011 and 2023 with a benefit-to-cost ratio of 3.1:1-3.2:1. Although we were unable to monetize benefits for expected improved immunization coverage, surveillance, or reduced medication errors, based on our findings, we expect that using 2D barcodes will lower vaccine documentation costs, facilitate data capture, and enhance immunization data quality. Copyright © 2013

  1. Survival benefit of mantle cell lymphoma patients enrolled in clinical trials; a joint study from the LYSA group and French cancer registries.

    Science.gov (United States)

    Augustin, Alix; Le Gouill, Steven; Gressin, Rémy; Bertaut, Aurélie; Monnereau, Alain; Woronoff, Anne-Sophie; Trétarre, Brigitte; Delafosse, Patricia; Troussard, Xavier; Moreau, Anne; Hermine, Olivier; Maynadié, Marc

    2017-10-11

    Mantle cell lymphoma (MCL) is a rare non-Hodgkin's lymphoma entity with a poor prognosis. Therapeutic advances have improved the survival of patients enrolled in clinical trials; however, their impact on patients outside clinical trials remains unclear. In this work, we compared patient outcome inside and outside clinical trials. We identified MCL patients recorded in six French population-based registries between 2008 and 2012 to perform a comparison with patients enrolled in two prospective multicenter MCL clinical trials conducted by the LYSA group during the same period. Variables associated with inclusion in a clinical trial were identified using a logistic regression. Pohar-Perme estimator and Nelson et al. flexible parametric model was used to estimate net survival probabilities and prognosis factors on excess mortality. A total of 312 registry patients were compared to the 372 patients enrolled in LYSA clinical trials. Patients included in clinical trials were younger (median age 60 vs 74, p enrollment [OR = 0.09 (0.06-0.12) and OR = 1.61 (1.11-2.34), respectively]. The 4 year net survival was better in clinical trials [79.9% (75.9-84.7) vs 60.3% (53.6-67.0)]. This result was confirmed in multivariate analysis in patients older than 65 years with a lower excess mortality rate [0.33 (0.17-0.66)]. MCL included in trials are highly selected patients who are not representative of MCL patients who are encountered in everyday practice. With widened inclusion criteria, clinical trial patients could be more representative of the general population.

  2. Clinical endocannabinoid deficiency (CECD) revisited: can this concept explain the therapeutic benefits of cannabis in migraine, fibromyalgia, irritable bowel syndrome and other treatment-resistant conditions?

    Science.gov (United States)

    Smith, Steele Clarke; Wagner, Mark S

    2014-01-01

    Ethan B. Russo's paper of December 1, 2003 explored the concept of a clinical endocannabinoid deficiency (CECD) underlying the pathophysiology of migraine, fibromyalgia, irritable bowel syndrome and other functional conditions alleviated by clinical cannabis. Available literature was reviewed, including searches via the National Library of medicine database and other sources. A review of the literature indicates that significant progress has been made since Dr. Ethan B. Russo's landmark paper, just ten years ago (February 2, 2004). Investigation at that time suggested that cannabinoids can block spinal, peripheral and gastrointestional mechanisms that promote pain in headache, fibromyalgia, irritable bowel syndrome and muscle spasm. Subsequent research has confirmed that underlying endocannabinoid deficiencies indeed play a role in migraine, fibromyalgia, irritable bowel syndrome and a growing list of other medical conditions. Clinical experience is bearing this out. Further research and especially, clinical trials will further demonstrate the usefulness of medical cannabis. As legal barriers fall and scientific bias fades this will become more apparent.

  3. A theoretical framework of organizational change

    NARCIS (Netherlands)

    Jacobs, G.; Polos, L.; van Witteloostuijn, A.; Christe-Zyse, J.

    2013-01-01

    Purpose – Organizational change is a risky endeavour. Most change initiatives fall short on their goals and produce high opportunity and process costs, which at times outweigh the content benefits of organizational change. This paper seeks to develop a framework, offering a theoretical toolbox to

  4. Comparative Benefits and Harms of Antidepressant, Psychological, Complementary, and Exercise Treatments for Major Depression: An Evidence Report for a Clinical Practice Guideline From the American College of Physicians.

    Science.gov (United States)

    Gartlehner, Gerald; Gaynes, Bradley N; Amick, Halle R; Asher, Gary N; Morgan, Laura C; Coker-Schwimmer, Emmanuel; Forneris, Catherine; Boland, Erin; Lux, Linda J; Gaylord, Susan; Bann, Carla; Pierl, Christiane Barbara; Lohr, Kathleen N

    2016-03-01

    Primary care patients and clinicians may prefer options other than second-generation antidepressants for the treatment of major depressive disorder (MDD). The comparative benefits and harms of antidepressants and alternative treatments are unclear. To compare the benefits and harms of second-generation antidepressants and psychological, complementary and alternative medicine (CAM), and exercise treatments as first- and second-step interventions for adults with acute MDD. English-, German-, and Italian-language studies from multiple electronic databases (January 1990 to September 2015); trial registries and gray-literature databases were used to identify unpublished research. Two investigators independently selected comparative randomized trials of at least 6 weeks' duration on health outcomes of adult outpatients; nonrandomized studies were eligible for harms. Reviewers abstracted data on study design, participants, interventions, and outcomes; rated the risk of bias; and graded the strength of evidence. A senior reviewer confirmed data and ratings. 45 trials met inclusion criteria. On the basis of moderate-strength evidence, cognitive behavioral therapy (CBT) and antidepressants led to similar response rates (relative risk [RR], 0.90 [95% CI, 0.76 to 1.07]) and remission rates (RR, 0.98 [CI, 0.73 to 1.32]). In trials, antidepressants had higher risks for adverse events than most other treatment options; no information from nonrandomized studies was available. The evidence was too limited to make firm conclusions about differences in the benefits and harms of antidepressants compared with other treatment options as first-step therapies for acute MDD. For second-step therapies, different switching and augmentation strategies provided similar symptom relief. High dropout rates, dosing inequalities, small sample sizes, and poor assessment of adverse events limit confidence in the evidence. Given their similar efficacy, CBT and antidepressants are both viable choices

  5. Humour: some theoretical and clinical remarks

    Directory of Open Access Journals (Sweden)

    David Meghnagi

    2012-06-01

    Full Text Available The model used by Freud to explain the secret of laughter in response to wit is one of energy release. And yet, although his starting point was a reductionistic interpretation dominated by the concepts of censure and the bypassing of censure through unconscious desire and the need for release of accumulated tension in the organism, Freud was able to go beyond the limits imposed by his own definition in his analysis of his carefully collected Jewish jokes and so provide us with an analytical model valid for both literature and art. In the wake of Freud‟s writings and of research carried out by Kris and Gombrich, the author sets out to demonstrate how there is a third form of logic involved in wit and humour, in addition to the primary and secondary process, which relates them to literature and art.

  6. Transsexual subtypes : Clinical and theoretical significance

    NARCIS (Netherlands)

    Smith, YLS; van Goozen, SHM; Kuiper, AJ; Cohen-Kettenis, PT

    2005-01-01

    The present study was designed to investigate whether transsexuals can be validly subdivided into subtypes on the basis of sexual orientation, and whether differences between subtypes of transsexuals are similar for male-to-female (ME) and female-to-male transsexuals (FMs). Within a large

  7. Suicide Seasonality : Theoretical and Clinical Implications

    OpenAIRE

    Makris, Georgios

    2017-01-01

    Background: Although suicide seasonality has been well-documented, surprisingly little is known about its underlying mechanisms. Methods: In this thesis, data from three Swedish registers (Cause of Death Register, National Patient Register, Prescribed Drugs Register) and data from the Swedish Meteorological and Hydrological Institute were used. In Study I, the amplitude of suicide seasonality was estimated in completed suicides in 1992-2003 in individuals with different antidepressant medicat...

  8. The humor: Theoretical considerations and clinical

    Directory of Open Access Journals (Sweden)

    David Meghnagi

    2011-06-01

    Full Text Available Il modello utilizzato da Freud per spiegare il segreto del riso nei motti di spirito è di tipo energetico. Eppure, pur muovendo da una lettura riduzionistica dove a dominare sono la censura e il suo aggiramento ad opera del desiderio inconscio e del bisogno di scarica della tensione accumulata dall’organismo, nell’interpretazione delle storielle ebraiche raccolte con cura, Freud riuscì a oltrepassare i limiti imposti dalla sua impostazione, fornendo un modello di indagine valido per la letteratura e per l’arte. Sulla scia delle opere di Freud e degli studi di Kris e di Gombrich e delle moderne teorie linguistiche, l’autore si propone di mostrare che nel motto e nell’umorismo sia all’opera una logica terza da distinguersi dal processo primario e secondario che li apparenta alla letteratura e all’arte.

  9. Clinical benefit of fixed-dose dual bronchodilation with glycopyrronium and indacaterol once daily in patients with chronic obstructive pulmonary disease

    DEFF Research Database (Denmark)

    Ulrik, Charlotte Suppli

    2014-01-01

    BACKGROUND AND AIM: Long-acting bronchodilators are the preferred option for maintenance therapy of patients with chronic obstructive pulmonary disease (COPD). The aim of this review is to provide an overview of the clinical studies evaluating the clinical efficacy of the once-daily fixed-dose du...... for chronic Obstructive Lung Disease [GOLD] spirometric criteria). Furthermore, a very recent study has shown that fixed-dose indacaterol/glycopyrronium improves exercise endurance time compared with placebo, although no significant difference was observed between fixed-dose indacaterol...

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

    NARCIS (Netherlands)

    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.; Hoffman, J.; Cahill, S.; Petersen, T.; Keiser, P.; Putnam, B.; Levinson, R.; Feinberg, J.; Baer, J.; Zelasky, C.; Pedersen, S.; Nicotera, J.; Bailey, V.; Nichols, C.; Quinn, J.; Norris, J.; Valle, S.; Moe, A.; Johiro, A.; Jacobson, M.; Volinski, J.; Storey, S.; Schouten, J. [=Judith; Mildvan, D.; Revuelta, M.; Hutt, R.; Vasquez, M.; Greisberger, C.; Reichman, R.; Riddler, S.; Rutecki, B.; Koletar, S. L.; Gochnour, D.; Salata, R. A.; Walton, P.; Rodriguez, M.; Kessels, L.; Coleman, K.; Lyons, A.; Tashima, K. T.; Sousa, H.; O'Brien, W. A.; Mogridge, C.; Connor, J. Noel; Crawford, M.; Palmore, M.; Patrick, E. R.; Bolivar, H. H.; Fischl, M. A.; Jacobson, Mark; Alston-Smith, Beverly L.; Foutes, Marilyn; Andersen, Janet; Jabs, Douglas; Walker, David; Ferguson, Elaine; Crumpacker, Clyde S.; Griffiths, Paul; Spector, Stephen A.; Kerkau, Melissa; Webb, Nancy

    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

  11. Six weeks of continuous joint distraction appears sufficient for clinical benefit and cartilaginous tissue repair in the treatment of knee osteoarthritis

    NARCIS (Netherlands)

    van der Woude, J. A D; van Heerwaarden, R. J.; Spruijt, S.; Eckstein, F.; Maschek, S.; van Roermund, P. M.; Custers, R. J H; van Spil, W. E.; Mastbergen, S. C.; Lafeber, F. P J G

    2016-01-01

    Background Knee joint distraction (KJD) is a surgical joint-preserving treatment in which the knee joint is temporarily distracted by an external frame. It is associated with joint tissue repair and clinical improvement. Initially, patients were submitted to an eight-week distraction period, and

  12. Net clinical benefit of combination anticoagulant and antiplatelet therapy versus anticoagulation alone in atrial fibrillation patients: Results from the amadeus trial

    NARCIS (Netherlands)

    Lane, Deirdre; Kamphuisen, Pieter; Minini, Pascal; De Peuter, Olaf R.; Buller, Harry R.; Lip, Gregory Y. H.

    2010-01-01

    Background: To compare the effect of combination anticoagulant and antiplatelet (AP) therapy with anticoagulation alone on stroke and bleeding risk in atrial fibrillation (AF) patients and examine predictors of clinically relevant bleeding. Methods: Post-hoc analysis of 4576 AF patients [mean (SD)

  13. High frequency of resistance, lack of clinical benefit, and poor outcomes in capreomycin treated South African patients with extensively drug-resistant tuberculosis.

    Directory of Open Access Journals (Sweden)

    Elize Pietersen

    Full Text Available There are limited data about the epidemiology and treatment-related outcomes associated with capreomycin resistance in patients with XDR-TB. Capreomycin achieves high serum concentrations relative to MIC but whether capreomycin has therapeutic benefit despite microbiological resistance remains unclear.We reviewed the susceptibility profiles and outcomes associated with capreomycin usage in patients diagnosed with XDR-TB between August 2002 and October 2012 in two provinces of South Africa. Patients whose isolates were genotypically tested for capreomycin resistance were included in the analysis.Of 178 XDR-TB patients 41% were HIV-infected. 87% (154/178 isolates contained a capreomycin resistance-conferring mutation [80% (143/178 rrs A1401G and 6% (11/178 were heteroresistant (containing both the rrs A1401G mutation and wild-type sequences]. Previous MDR-TB treatment, prior usage of kanamycin, or strain type was not associated with capreomycin resistance. 92% (163/178 of XDR-TB patients were empirically treated with capreomycin. Capreomycin resistance decreased the odds of sputum culture conversion. In capreomycin sensitive and resistant persons combined weight at diagnosis was the only independent predictor for survival (p=<0.001. By contrast, HIV status and use of co-amoxicillin/clavulanic acid were independent predictors of mortality (p=<0.05. Capreomycin usage was not associated with survival or culture conversion when the analysis was restricted to those whose isolates were resistant to capreomycin.In South Africa the frequency of capreomycin conferring mutations was extremely high in XDR-TB isolates. In those with capreomycin resistance there appeared to be no therapeutic benefit of using capreomycin. These data inform susceptibility testing and the design of treatment regimens for XDR-TB in TB endemic settings.

  14. High rates of adherence and treatment success in a public and public-private HIV clinic in India: potential benefits of standardized national care delivery systems

    Directory of Open Access Journals (Sweden)

    Heylen Elsa

    2011-10-01

    Full Text Available Abstract Background The massive scale-up of antiretroviral treatment (ART access worldwide has brought tremendous benefit to populations affected by HIV/AIDS. Optimising HIV care in countries with diverse medical systems is critical; however data on best practices for HIV healthcare delivery in resource-constrained settings are limited. This study aimed to understand patient characteristics and treatment outcomes from different HIV healthcare settings in Bangalore, India. Methods Participants from public, private and public-private HIV healthcare settings were recruited between 2007 and 2009 and were administered structured interviews by trained staff. Self-reported adherence was measured using the visual analogue scale to capture adherence over the past month, and a history of treatment interruptions (defined as having missed medications for more than 48 hours in the past three months. In addition, CD4 count and viral load (VL were measured; genotyping for drug resistance-associated mutations was performed on those who were in virological failure (VL > 1000 copies/ml. Results A total of 471 individuals were included in the analysis (263 from the public facility, 149 from the public-private facility and 59 from the private center. Private facility patients were more likely to be male, with higher education levels and incomes. More participants reported ≥ 95% adherence among public and public-private groups compared to private participants (public 97%; private 88%; public-private 93%, p Conclusions Adherence and treatment success was significantly higher among patients from public and public-private settings compared with patients from private facilities. These results suggest a possible benefit of the standardized care delivery system established in public and public-private health facilities where counselling by a multi-disciplinary team of workers is integral to provision of ART. Strengthening and increasing public-private partnerships can

  15. Benefit of combining quantitative cardiac CT parameters with troponin I for predicting right ventricular dysfunction and adverse clinical events in patients with acute pulmonary embolism

    Energy Technology Data Exchange (ETDEWEB)

    Meyer, Mathias, E-mail: mr.meyer.mathias@gmail.com [Department of Clinical Radiology and Nuclear Medicine, University Medical Center Mannheim, Medical Faculty Mannheim, Heidelberg University, Theodor-Kutzer-Ufer 1-3, D-68167 Mannheim (Germany); Fink, Christian, E-mail: Christian.Fink@umm.de [Department of Clinical Radiology and Nuclear Medicine, University Medical Center Mannheim, Medical Faculty Mannheim, Heidelberg University, Theodor-Kutzer-Ufer 1-3, D-68167 Mannheim (Germany); Roeger, Susanne, E-mail: susanne.roeger@umm.de [1st Department of Medicine, University Medical Center Mannheim, Medical Faculty Mannheim, Heidelberg University, Theodor-Kutzer-Ufer 1-3, D-68167 Mannheim (Germany); Apfaltrer, Paul, E-mail: Paul.Apfaltrer@umm.de [Department of Clinical Radiology and Nuclear Medicine, University Medical Center Mannheim, Medical Faculty Mannheim, Heidelberg University, Theodor-Kutzer-Ufer 1-3, D-68167 Mannheim (Germany); Haghi, Dariush, E-mail: dariush.haghi@umm.de [1st Department of Medicine, University Medical Center Mannheim, Medical Faculty Mannheim, Heidelberg University, Theodor-Kutzer-Ufer 1-3, D-68167 Mannheim (Germany); Kaminski, Wolfgang E., E-mail: wolfgang.kaminski@umm.de [Department of Clinical Chemistry, University Medical Center Mannheim, Medical Faculty Mannheim, Heidelberg University, Theodor-Kutzer-Ufer 1-3, D-68167 Mannheim (Germany); Neumaier, Michael, E-mail: michael.neumaier@medma.uni-heidelberg.de [Department of Clinical Chemistry, University Medical Center Mannheim, Medical Faculty Mannheim, Heidelberg University, Theodor-Kutzer-Ufer 1-3, D-68167 Mannheim (Germany); Schoenberg, Stefan O., E-mail: Stefan.Schoenberg@umm.de [Department of Clinical Radiology and Nuclear Medicine, University Medical Center Mannheim, Medical Faculty Mannheim, Heidelberg University, Theodor-Kutzer-Ufer 1-3, D-68167 Mannheim (Germany); and others

    2012-11-15

    Objective: To prospectively evaluate the diagnostic accuracy of quantitative cardiac CT parameters alone and in combination with troponin I for the assessment of right ventricular dysfunction (RVD) and adverse clinical events in patients with acute pulmonary embolism (PE). Materials and results: This prospective study had institutional review board approval and was HIPAA compliant. In total 83 patients with confirmed PE underwent echocardiography and troponin I serum level measurements within 24 h. Three established cardiac CT measurements for the assessment of RVD were obtained (RV/LV{sub axial}, RV/LV{sub 4-CH}, and RV/LV{sub volume}). CT measurements and troponin I serum levels were correlated with RVD found on echocardiography and adverse clinical events according to Management Strategies and Prognosis in Pulmonary Embolism Trial-3 (MAPPET-3 criteria. 31 of 83 patients with PE had RVD on echocardiography and 39 of 83 patients had adverse clinical events. A RV/LV{sub volume} ratio > 1.43 showed the highest area under the curve (AUC) (0.65) for the prediction of adverse clinical events when compared to RV/LV{sub axial}, RV/LV{sub 4Ch} and troponin I. The AUC for the detection of RVD of RV/LV{sub axial}, RV/LV{sub 4Ch}, RV/LV{sub volume}, and troponin I were 0.86, 0.86, 0.92, and 0.69, respectively. Combination of RV/LV{sub axial}, RV/LV{sub 4Ch}, RV/LV{sub volume} with troponin I increased the AUC to 0.87, 0.87 and 0.93, respectively. Conclusion: A combination of cardiac CT parameters and troponin I measurements improves the diagnostic accuracy for detecting RVD and predicting adverse clinical events if compared to either test alone.

  16. Theoretical nuclear physics

    CERN Document Server

    Blatt, John M

    1979-01-01

    A classic work by two leading physicists and scientific educators endures as an uncommonly clear and cogent investigation and correlation of key aspects of theoretical nuclear physics. It is probably the most widely adopted book on the subject. The authors approach the subject as ""the theoretical concepts, methods, and considerations which have been devised in order to interpret the experimental material and to advance our ability to predict and control nuclear phenomena.""The present volume does not pretend to cover all aspects of theoretical nuclear physics. Its coverage is restricted to

  17. 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.

    Science.gov (United States)

    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

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

    Directory of Open Access Journals (Sweden)

    Anna Koumarianou

    2016-01-01

    Full Text Available 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.

  19. In reply to "Commentary to: Endoscopic and clinical benefits of hyaluronic acid in children with chronic adenoiditis and middle ear disease", by Zhengcai Lou.

    Science.gov (United States)

    Torretta, S; Marchisio, P; Rinaldi, V; Carioli, D; Nazzari, E; Pignataro, L

    2018-03-01

    Some considerations will be expressed in consideration of the commentary previously published. In particular, we underline that no other medications were administered to the patients during the study period and any clinical evaluation was postponed in case of acute upper respiratory tract infection in the previous 14 days. We strongly advocate antibiotic treatment during any acute otitis media episode, and we agree that topically administered hyaluronic acid should be considered as a supporting treatment, "complementary to traditional therapies" in children with recurrent disease.

  20. Theoretical Computer Science

    DEFF Research Database (Denmark)

    2002-01-01

    The proceedings contains 8 papers from the Conference on Theoretical Computer Science. Topics discussed include: query by committee, linear separation and random walks; hardness results for neural network approximation problems; a geometric approach to leveraging weak learners; mind change...

  1. Theoretical chemistry in Belgium a topical collection from theoretical chemistry accounts

    CERN Document Server

    Champagne, Benoît; De Proft, Frank; Leyssens, Tom

    2014-01-01

    Readers of this volume can take a tour around the research locations in Belgium which are active in theoretical and computational chemistry. Selected researchers from Belgium present research highlights of their work. Originally published in the journal Theoretical Chemistry Accounts, these outstanding contributions are now available in a hardcover print format. This volume will be of benefit in particular to those research groups and libraries that have chosen to have only electronic access to the journal. It also provides valuable content for all researchers in theoretical chemistry.

  2. Theoretical physics and astrophysics

    CERN Document Server

    Ginzburg, Vitalii Lazarevich

    1979-01-01

    The aim of this book is to present, on the one hand various topics in theoretical physics in depth - especially topics related to electrodynamics - and on the other hand to show how these topics find applications in various aspects of astrophysics. The first text on theoretical physics and astrophysical applications, it covers many recent advances including those in X-ray, &ggr;-ray and radio-astronomy, with comprehensive coverage of the literature

  3. Response to [90Yttrium-DOTA]-TOC treatment is associated with long-term survival benefit in metastasized medullary thyroid cancer: a phase II clinical trial.

    Science.gov (United States)

    Iten, Fabienne; Müller, Beat; Schindler, Christian; Rochlitz, Christoph; Oertli, Daniel; Mäcke, Helmut R; Müller-Brand, Jan; Walter, Martin A

    2007-11-15

    We aimed to explore the efficacy of (90)Yttrium-1,4,7,10-tetra-azacyclododecane N,N',N'',N-'''-tetraacetic acid ((90)Y-DOTA)-Tyr(3)-octreotide (TOC) therapy in advanced medullary thyroid cancer. In a phase II trial, we investigated the response, survival, and long-term safety profile of systemic [(90)Y-DOTA]-TOC treatment in metastasized medullary thyroid cancer. Adverse events were assessed according to the criteria of the National Cancer Institute. Survival analyses were done using multiple regression models. Thirty-one patients were enrolled. A median cumulative activity of 12.6 GBq (range, 1.7-29.6 GBq) of [(90)Y-DOTA]-TOC was administered. Response was found in nine patients (29.0%). Four patients (12.9%) developed hematologic toxicities and seven patients (22.6%) developed renal toxicities. Response to treatment was associated with longer survival from time of diagnosis (hazard ratio, 0.20; 95% confidence interval, 0.05-0.81; P = 0.02) and from time of first [(90)Y-DOTA]-TOC therapy (hazard ratio, 0.16; 95% confidence interval, 0.04-0.63; P = 0.009). The visual grade of scintigraphic tumor uptake was not associated with treatment response or survival. Response to [(90)Y-DOTA]-TOC therapy in metastasized medullary thyroid cancer is associated with a long-term survival benefit. Treatment should be considered independently from the result of the pretherapeutic scintigraphy.

  4. Robotic Camera Assistance and Its Benefit in 1033 Traditional Laparoscopic Procedures: Prospective Clinical Trial Using a Joystick-guided Camera Holder.

    Science.gov (United States)

    Holländer, Sebastian W; Klingen, Hans Joachim; Fritz, Marliese; Djalali, Peter; Birk, Dieter

    2014-11-01

    Despite advances in instruments and techniques in laparoscopic surgery, one thing remains uncomfortable: the camera assistance. The aim of this study was to investigate the benefit of a joystick-guided camera holder (SoloAssist®, Aktormed, Barbing, Germany) for laparoscopic surgery and to compare the robotic assistance to human assistance. 1033 consecutive laparoscopic procedures were performed assisted by the SoloAssist®. Failures and aborts were documented and nine surgeons were interviewed by questionnaire regarding their experiences. In 71 of 1033 procedures, robotic assistance was aborted and the procedure was continued manually, mostly because of frequent changes of position, narrow spaces, and adverse angular degrees. One case of short circuit was reported. Emergency stop was necessary in three cases due to uncontrolled movement into the abdominal cavity. Eight of nine surgeons prefer robotic to human assistance, mostly because of a steady image and self-control. The SoloAssist® robot is a reliable system for laparoscopic procedures. Emergency shutdown was necessary in only three cases. Some minor weak spots could have been identified. Most surgeons prefer robotic assistance to human assistance. We feel that the SoloAssist® makes standard laparoscopic surgery more comfortable and further development is desirable, but it cannot fully replace a human assistant.

  5. Does Problem-Solving Training for Family Caregivers Benefit Their Care Recipients With Severe Disabilities? A Latent Growth Model of the Project CLUES Randomized Clinical Trial

    Science.gov (United States)

    Berry, Jack W.; Elliott, Timothy R.; Grant, Joan S.; Edwards, Gary; Fine, Philip R.

    2012-01-01

    Objective To examine whether an individualized problem-solving intervention provided to family caregivers of persons with severe disabilities provides benefits to both caregivers and their care recipients. Design Family caregivers were randomly assigned to an education-only control group or a problem-solving training (PST) intervention group. Participants received monthly contacts for 1 year. Participants Family caregivers (129 women, 18 men) and their care recipients (81 women, 66 men) consented to participate. Main Outcome Measures Caregivers completed the Social Problem-Solving Inventory–Revised, the Center for Epidemiological Studies-Depression scale, the Satisfaction with Life scale, and a measure of health complaints at baseline and in 3 additional assessments throughout the year. Care recipient depression was assessed with a short form of the Hamilton Depression Scale. Results Latent growth modeling was used to analyze data from the dyads. Caregivers who received PST reported a significant decrease in depression over time, and they also displayed gains in constructive problem-solving abilities and decreases in dysfunctional problem-solving abilities. Care recipients displayed significant decreases in depression over time, and these decreases were significantly associated with decreases in caregiver depression in response to training. Conclusions PST significantly improved the problem-solving skills of community-residing caregivers and also lessened their depressive symptoms. Care recipients in the PST group also had reductions in depression over time, and it appears that decreases in caregiver depression may account for this effect. PMID:22686549

  6. Six weeks of continuous joint distraction appears sufficient for clinical benefit and cartilaginous tissue repair in the treatment of knee osteoarthritis.

    Science.gov (United States)

    van der Woude, J A D; van Heerwaarden, R J; Spruijt, S; Eckstein, F; Maschek, S; van Roermund, P M; Custers, R J H; van Spil, W E; Mastbergen, S C; Lafeber, F P J G

    2016-10-01

    Knee joint distraction (KJD) is a surgical joint-preserving treatment in which the knee joint is temporarily distracted by an external frame. It is associated with joint tissue repair and clinical improvement. Initially, patients were submitted to an eight-week distraction period, and currently patients are submitted to a six-week distraction period. This study evaluates whether a shorter distraction period influences the outcome. Both groups consisted of 20 patients. Clinical outcome was assessed by WOMAC questionnaires and VAS-pain. Cartilaginous tissue repair was assessed by radiographic joint space width (JSW) and MRI-observed cartilage thickness. Baseline data between both groups were comparable. Both groups showed an increase in total WOMAC score; 24±4 in the six-week group and 32±5 in the eight-week group (both p<0.001). Mean JSW increased 0.9±0.3mm in the six-week group and 1.1±0.3mm in the eight-week group (p=0.729 between groups). The increase in mean cartilage thickness on MRI was 0.6±0.2mm in the eight-week group and 0.4±0.1mm in the six-week group (p=0.277). A shorter distraction period does not influence short-term clinical and structural outcomes statistically significantly, although effect sizes tend to be smaller in six week KJD as compared to eight week KJD. Copyright © 2016 Elsevier B.V. All rights reserved.

  7. [A multicentre randomised clinical trial to evaluate the benefit of testing for thrombophilia following a first venous thromboembolism: the NOSTRADAMUS study].

    Science.gov (United States)

    Cohn, D M; Middeldorp, S

    2007-02-10

    It is unknown whether testing patients for thrombophilia after a first episode of venous thromboembolism (VTE) and prolonging anticoagulant treatment in those with thrombophilia is justified. The NOSTRADAMUS trial, a multicentre randomised controlled trial, is being conducted to assess whether this strategy is beneficial in terms of clinical outcomes, quality of life and costs. Patients with a first VTE will be randomly assigned to one of two groups. The first group will be tested for thrombophilia and subsequently receive the test results; those in the second group will be tested but the results will not be disclosed. A total of 1336 patients will be included. Additional anticoagulant treatment for a predefined period will be initiated in patients found to have thrombophilia, while others will receive a standard predefined duration oftreatment. Primary outcomes are the risk of recurrent VTE, clinically important bleeding and the composite outcome of both. Other outcomes include overall quality of life and costs associated with outcome measures 18 months after the initial episode of VTE.

  8. Health care professionals' experience, understanding and perception of need of advanced cancer patients with cachexia and their families: The benefits of a dedicated clinic.

    Science.gov (United States)

    Scott, David; Reid, Joanne; Hudson, Peter; Martin, Peter; Porter, Sam

    2016-12-30

    Cachexia is defined as the on-going loss of skeletal muscle mass that cannot be fully reversed by conventional nutritional support. It is found in up to 80% of patients with advanced cancer and has profound psycho-social consequences for patients and their families. Previous studies demonstrate that many healthcare professionals receive little formal education in cachexia management leading them to feel that they have limited understanding of the syndrome and cannot intervene effectively. This study aims to examine the value of a dedicated cachexia clinic and its influence on staff understanding and practice. An exploratory qualitative study was conducted. The study employed semi-structured interviews with a range of healthcare professionals responsible for designing and delivering cancer care in a large teaching hospital in Australia. This hospital had a dedicated cachexia clinic. In-depth interviews were conducted with 8 healthcare professionals and senior managers. Four themes were identified: formal and informal education; knowledge and understanding; truth telling in cachexia and palliative care; and, a multi-disciplinary approach. Findings show that improved knowledge and understanding across a staff body can lead to enhanced staff confidence and a willingness to address cancer cachexia and its consequences with patients and their families. Comparisons with similar previous research demonstrate the advantages of providing a structure for staff to gain knowledge about cachexia and how this can contribute to feelings of improved understanding and confidence necessary to respond to the challenge of cachexia.

  9. A clinical analysis of 500 medico-legal claims evaluating the causes and assessing the potential benefit of alternative dispute resolution.

    Science.gov (United States)

    B-Lynch, C; Coker, A; Dua, J A

    1996-12-01

    1. To evaluate the common causes of medico-legal dispute in obstetrics and gynaecology. 2. To assess the potential benefit of early alternative dispute resolution. A prospective analysis of over 500 cases submitted from over 100 solicitors between 1984 and 1994 for medical expert opinion on potential medico-legal claims. Five hundred consecutive cases that met the inclusion criteria: 488 from the United Kingdom and 12 from abroad (Hong Kong, Republic of Ireland). The main principles underlining medico-legal disputes and causes of such claims. Analysis of 500 claims show 46% were misguided allegations, 19% incompetent care, 12% error of judgement, 9% lack of expertise, 7% failure of communication, 6% poor supervision and 1% inadequate staffing. Of the misguided allegations 119/225 cases (59%) were obstetric and 111/275 (40%) cases were gynaecological. The most common cause of obstetric dispute was "cerebral palsy' (22%), while the commonest cause of gynaecological dispute was failed sterilisation (19%). Settled claims were under-reported by solicitors. Because of the high percentage (46%) of misguided allegations, an alternative course of dispute resolution must be a realistic way forward. This course of action, combined with improved communication, could result in a major reduction in the costs of potential medical litigation. Early alternative dispute resolution should be considered in an attempt to reduce the escalating quantum of damages and costs. We recommend recruiting independent, experienced and unbiased consultants in active practice within the appropriate specialty to review such cases at the level of hospital complaints management as an in house review procedure, particularly for small and moderate-sized claims, as a means whereby doctors can retain control of medico-legal disputes, in contrast to control by the legal profession.

  10. Gregory S. Ezra a festschrift from theoretical chemistry accounts

    CERN Document Server

    Keshavamurthy, Srihari

    2015-01-01

    In this Festschrift dedicated to the 60th birthday of Gregory S. Ezra, selected researchers in theoretical chemistry present research highlights on major developments in the field. Originally published in the journal Theoretical Chemistry Accounts, these outstanding contributions are now available in a hardcover print format, as well as a special electronic edition. This volume provides valuable content for all researchers in theoretical chemistry and will especially benefit those research groups and libraries with limited access to the journal.

  11. Marco Antonio Chaer Nascimento a festschrift from theoretical chemistry accounts

    CERN Document Server

    Ornellas, Fernando R

    2014-01-01

    In this Festschrift dedicated to the 65th birthday of Marco Antonio Chaer Nascimento, selected researchers in theoretical chemistry present research highlights on major developments in the field. Originally published in the journal Theoretical Chemistry Accounts, these outstanding contributions are now available in a hardcover print format. This volume will be of benefit in particular to those research groups and libraries that have chosen to have only electronic access to the journal. It also provides valuable content for all researchers in theoretical chemistry.

  12. [Benefit of the rapid test determine HIV1/2 in the clinical diagnosis of HIV infection in Ibn Rochd hospital of Casablanca, Morocco].

    Science.gov (United States)

    Ouladlahsen, A; Bensghir, R; Karkouri, M; Elharti, E; Oumzil, H; Himmich, H; Elfilali, K M; Chakib, A

    2012-08-01

    In Morocco, diagnosis of HIV infection remains late, which seriously compromises the timely management of HIV infection in the era of HAART therapies. Rapid test represents a good opportunity to improve the access to early screening of HIV. The objective of this study is to report the experience of the infectious diseases unit of the Ibn Rochd University hospital center of Casablanca, in the use of the rapid test in clinical screening of HIV. This retrospective study reports data relevant to the use of the rapid test Determine VIH-1/2, Abbott Diagnostics, since its introduction in the infectious diseases unit in April 2006 up to December 2009. The test was performed for patients from the infectious diseases unit and patients hospitalized in different units of the Ibn Rochd University hospital center, after their consent. Test was ordered systematically by clinicians in case of any suspected symptom related to HIV and immunodepression. Positive samples were confirmed by Western Blot test, at the National Reference Laboratory for HIV, within the Institut National d'Hygiène in Rabat. Between 2006 and 2009, 1105 rapid tests were performed, among which 16.3% were positive. All results were provided to patients and none were lost to follow-up. The main reasons for the prescription of an HIV test were tuberculosis (26.3%) and chronic diarrhea (9.9%) for inpatients. For outpatients, the main symptoms were sexually transmissible infections (16.7%) and weight loss (15.7%). Results of the tests allowed us to adapt the treatment in case of suspicion of pneumocystosis (12 cases) and toxoplasmosis (seven cases). The introduction of the rapid test for HIV clinical screening in the hospital facilities improved considerably the access to diagnosis and consequently allowed a timely management of HIV infection. Copyright © 2012 Elsevier Masson SAS. All rights reserved.

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

    Science.gov (United States)

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

    2015-01-01

    To evaluate the change in respiratory function and functional capacity according to the type of preoperative fasting. 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. 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. Abbreviation of preoperative fasting time with ingestion of maltodextrin solution is beneficial to pulmonary function and preserves dominant handgrip strength.

  14. Once-daily glycopyrronium bromide, a long-acting muscarinic antagonist, for chronic obstructive pulmonary disease: a systematic review of clinical benefit

    Directory of Open Access Journals (Sweden)

    Ulrik CS

    2012-09-01

    Full Text Available Charlotte Suppli UlrikDepartment of Pulmonary Medicine, Hvidovre Hospital and University of Copenhagen, Copenhagen, DenmarkBackground: Long-acting bronchodilators are central in the pharmacological management of patients with chronic obstructive pulmonary disease (COPD. The aim of this systematic review is to provide an overview of the studies evaluating the safety and clinical efficacy of inhaled glycopyrronium bromide, a novel long-acting muscarinic antagonist, in patients with COPD.Methods: This study was performed as a systematic literature review.Results: Inhaled glycopyrronium bromide seems to be a safe and well tolerated long-acting muscarinic antagonist with a fast onset of action. In patients suffering from moderate to severe COPD, glycopyrronium bromide has clinically important effects on level of forced expiratory volume in one second, use of relief medication, percentage of days with no use of rescue medication, daytime dyspnea scores, and probably also on health status. Furthermore, in this group of patients, glycopyrronium bromide has beneficial effects on dynamic hyperinflation and exercise tolerance. Glycopyrronium bromide has been shown to reduce the rate of exacerbations in patients with moderate to severe COPD, but long-term controlled trials with exacerbation rate as the primary outcome variable have not been published yet.Conclusion: Once-daily inhaled glycopyrronium bromide has characteristics important for use in COPD, including a fast onset of action, sustained 24-hour bronchodilatation, and improvement in exercise tolerance, and therefore appears to have the potential for a significant role in the future management of COPD.Keywords: chronic obstructive pulmonary disease, glycopyrronium bromide, long-acting bronchodilators

  15. Building a global health education network for clinical care and research. The benefits and challenges of distance learning tools. Lessons learned from the Hopkins Center for Clinical Global Health Education.

    Science.gov (United States)

    Bollinger, Robert C; McKenzie-White, Jane; Gupta, Amita

    2011-06-01

    Expanding the capacity for clinical care and health research is a global priority and a global challenge. The Johns Hopkins Center for Clinical Global Health Education (CCGHE) was established in 2005 to provide access to high-quality training to health care providers in resource-limited settings. The CCGHE made a strategic decision to develop, use, and evaluate distance learning platforms to achieve its mission. In the initial years of this new program, several lessons have been learned that may be helpful to other programs considering the use of distance learning programs to expand global health clinical and research capacity. Copyright © 2011 Elsevier Inc. All rights reserved.

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

    Directory of Open Access Journals (Sweden)

    Landsmann B

    2016-01-01

    Full Text Available Barbara Landsmann,1,2 Daniela Pinter,2 Eva Pirker,1,2 Gerald Pichler,3 Walter Schippinger,3 Elisabeth M Weiss,1 Gabriel Mathie,2 Thomas Gattringer,2 Franz Fazekas,2 Christian Enzinger2,4 1Institute of Psychology, University of Graz, Graz, Austria; 2Department of Neurology, Medical University of Graz, Graz, Austria; 3Albert Schweitzer Clinic Graz, Graz, Austria; 4Division of Neuroradiology, Department of Radiology, Medical University of Graz, Graz, Austria 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

  17. Long-term clinical benefit and cost-effectiveness of an 8-week multimodal knee osteoarthritis management program incorporating intra-articular sodium hyaluronate (Hyalgan® injections

    Directory of Open Access Journals (Sweden)

    Miller LE

    2017-05-01

    Full Text Available Larry E Miller,1 Michael J Sloniewsky,2 Thomas E Gibbons,3 Janice G Johnston,4 Kent D Vosler,4 Saad Nasir5 1Miller Scientific Consulting, Inc., Asheville, NC, 2RMG Holding, Inc., Florence, 3Doctors Care, PA, Columbia, SC, 4Arrowhead Health Centers, Glendale, AZ, 5Fidia Pharma USA Inc., Parsippany, NJ, USA Background: Given the poor long-term effectiveness of focused nonsurgical knee osteoarthritis (OA treatments, alternative therapies are needed for patients who have unsuccessfully exhausted nonsurgical options.Methods: A telephone interview was conducted in patients who participated in a single 8-week multimodal knee OA treatment program (mean follow-up: 3.7 years, range: 2.7–4.9 years. The program consisted of five intra-articular knee injections of sodium hyaluronate (Hyalgan®, with each injection given 1 week apart, structured physical therapy, knee bracing, and patient education. Clinical outcomes included knee pain severity, Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC subscores, current medication use, and history of total knee arthroplasty. Base-case, subgroup, and sensitivity analyses were conducted to determine the incremental cost-effectiveness ratio (ICER of the treatment program with comparisons made to historical literature controls undergoing usual care. Results: A total of 218 patients (54% provided long-term follow-up data. Knee pain severity decreased 60% and WOMAC subscores decreased 33%–42% compared to baseline (all p<0.001. Total knee arthroplasty was performed in 22.8% (81/356 of knees during follow-up. The treatment program was highly cost-effective compared to usual care with a base-case ICER of $6,000 per quality-adjusted life year (QALY. Results of subgroup analyses, one-way deterministic sensitivity analyses, and second-order probabilistic sensitivity analyses resulted in ICERs ranging from $3,996 to $10,493 per QALY. The percentage of simulations with an ICER below willingness

  18. Clinical benefits of eplerenone in patients with systolic heart failure and mild symptoms when initiated shortly after hospital discharge: analysis from the EMPHASIS-HF trial.

    Science.gov (United States)

    Girerd, Nicolas; Collier, Tim; Pocock, Stuart; Krum, Henry; McMurray, John J; Swedberg, Karl; Van Veldhuisen, Dirk J; Vincent, John; Pitt, Bertram; Zannad, Faiez

    2015-09-07

    Cardiovascular hospitalization (CVH) in patients with heart failure (HF) is associated with a high post-discharge rate of early re-admission and CV death. Eplerenone might be effective in reducing the incidence of these adverse clinical outcomes during this period. The EMPHASIS-HF trial compared eplerenone with placebo added to standard therapy in 2737 patients with New York Heart Association class II HF and left ventricular ejection fraction ≤35%. We conducted a post hoc analysis in the 2338 patients randomized within 180 days of a CVH. The interaction between the time from the qualifying CVH to randomization and the primary outcome of CV death or hospitalization for HF (HHF), as well as other secondary outcomes, was assessed in Cox survival models. Most of the qualifying CVHs were HHF (N = 1496, 64.0%), acute coronary syndromes (N = 390, 16.7%), and arrhythmias (N = 197, 7.2%). The median time of study drug initiation from qualifying CVH was 42 days. The relative rate reductions in CV death/HHF, HHF, and all-cause mortality were similar (P for interaction = 0.65, 0.44, and 0.40, respectively) whether the treatment was initiated HF or acute coronary syndromes in patients with systolic HF and mild symptoms. Published on behalf of the European Society of Cardiology. All rights reserved. © The Author 2015. For permissions please email: journals.permissions@oup.com.

  19. Benefits of Semelil (ANGIPARSTM on oxidant-antioxidant balance in diabetic patients; A randomized, double-blind placebo controlled clinical trial

    Directory of Open Access Journals (Sweden)

    M Hemmatabadi

    2010-01-01

    Full Text Available "n "nBackground and the purpose of the study: Diabetes mellitus is one of the most common chronic diseases in the world with dreadful complications which not only is debilating for the patients but also puts a big burden on the health system.One of the mechanisms by which the complications of diabetes occur is imbalance in the oxidant-antioxidant equilibrium in the body and therefore many studies have been performed to either correct this equilibrium or delay the occurrence of the complications. "nMethods:In this randomized, double-blind placebo-controlled clinical trial, a total number of 61 subjects were divided into two groups and the antioxidant effects of a novel herbal drug, Semelil,was compared with placebo. Baseline laboratory tests including a complete blood count, fasting blood sugar,lipid profile,fasting plasma insulin, liver and renal function tests plus tumor necrotizing factor α (TNFα and C-reactive protein (CRP and homocystein were performed. Total antioxidant power assay, cellular lipid peroxidation assay, and nuclear damage (deoxyguanosine and carbonly molecules were also measured to help determination of state of antioxidants- oxidants equilibrium in serum. "nResult:Apart from deoxyguanosine, no significant change was found in TNFα or CRP levels in the studied group who received Semelil.Conclusion: Mechanisms other than antioxidant effects are involved for Semelil in the treatment of diabetic foot ulcers.

  20. Secukinumab sustains early patient-reported outcome benefits through 1 year: Results from 2 phase III randomized placebo-controlled clinical trials comparing secukinumab with etanercept.

    Science.gov (United States)

    Strober, Bruce; Gottlieb, Alice B; Sherif, Bintu; Mollon, Patrick; Gilloteau, Isabelle; McLeod, Lori; Fox, Todd; Mordin, Margaret; Gnanasakthy, Ari; Papavassilis, Charis; Lebwohl, Mark G

    2017-04-01

    Psoriasis is a chronic condition with negative impact on patients' quality of life that most often requires lifelong effective and safe treatment. This analysis focused on the effect of secukinumab treatment on patient-reported health-related quality of life as assessed by the Dermatology Life Quality Index (DLQI) in patients with moderate to severe psoriasis. The proportion of subjects achieving DLQI score 0/1 response at week 24, time to DLQI score 0/1 response, and sustained DLQI score 0/1 response up to week 52 were compared between secukinumab and etanercept. Of 1470 subjects, 1144 received secukinumab and 326 received etanercept. DLQI score 0/1 response rates were significantly higher for secukinumab than for etanercept at week 24. The median time to DLQI score 0/1 response was significantly shorter for secukinumab versus etanercept (12 vs 24 weeks; P etanercept over 52 weeks, consistent with greater clinical response. Copyright © 2016 American Academy of Dermatology, Inc. Published by Elsevier Inc. All rights reserved.

  1. A Model for Assessing the Clinical and Economic Benefits of Bone-forming Agents for Reducing Fractures in Postmenopausal Women at High, Near-term Risk of Osteoporotic Fracture.

    Science.gov (United States)

    O'Hanlon, Claire E; Parthan, Anju; Kruse, Morgan; Cartier, Shannon; Stollenwerk, Bjorn; Jiang, Yawen; Caloyeras, John P; Crittenden, Daria B; Barron, Richard

    2017-07-01

    The goal of this study was to assess and compare the potential clinical and economic value of emerging bone-forming agents using the only currently available agent, teriparatide, as a reference case in patients at high, near-term (imminent, 1- to 2-year) risk of osteoporotic fractures, extending to a lifetime horizon with sequenced antiresorptive agents for maintenance treatment. Analyses were performed by using a Markov cohort model accounting for time-specific fracture protection effects of bone-forming agents followed by antiresorptive treatment with denosumab. The alternative bone-forming agent profiles were defined by using assumptions regarding the onset and total magnitude of protection against fractures with teriparatide. The model cohort comprised 70-year-old female patients with T scores below -2.5 and a previous vertebral fracture. Outcomes included clinical fractures, direct costs, and quality-adjusted life years. The simulated treatment strategies were compared by calculating their incremental "value" (net monetary benefit). Improvements in the onset and magnitude of fracture protection (vs the teriparatide reference case) produced a net monetary benefit of $17,000,000 per 10,000 treated patients during the (1.5-year) bone-forming agent treatment period and $80,000,000 over a lifetime horizon that included 3.5 years of maintenance treatment with denosumab. Incorporating time-specific fracture effects in the Markov cohort model allowed for estimation of a range of cost savings, quality-adjusted life years gained, and clinical fractures avoided at different levels of fracture protection onset and magnitude. Results provide a first estimate of the potential "value" new bone-forming agents (romosozumab and abaloparatide) may confer relative to teriparatide. Copyright © 2017 The Authors. Published by Elsevier Inc. All rights reserved.

  2. Electronics Environmental Benefits Calculator

    Data.gov (United States)

    U.S. Environmental Protection Agency — The Electronics Environmental Benefits Calculator (EEBC) was developed to assist organizations in estimating the environmental benefits of greening their purchase,...

  3. The study to investigate the potential benefits of probiotics in yogurt, a patient-oriented, double-blind, cluster-randomised, placebo-controlled, clinical trial.

    Science.gov (United States)

    Merenstein, D J; Smith, K H; Scriven, M; Roberts, R F; Sanders, M E; Petterson, S

    2010-07-01

    Probiotic functional foods are widely advertised to consumers primarily based on probiotic supplements. Determine if consumption of yogurt containing a high dose of probiotics improves health in children ages 1-3 years attending daycare/school centers. Double-blinded, randomized, placebo-controlled, allocation concealment clinical trial. Outpatient participants in the Washington, DC area. 182 healthy children between the age of 1 and 3 years attending daycare/school at least 3 days a week. Active was a strawberry yogurt-based drink supplemented with Bifidobacterium animalis ssp. lactis (B. lactis) BB-12. The placebo was indistinguishable from the active drink, differing only in absence of the probiotic BB-12. Primary objective was to determine if consumption of a probiotic-containing yogurt-based drink decreases absences due to illnesses from daycare for children ages 1-3 years. Secondary was to determine if probiotic-containing yogurt-based drink improves overall parental satisfaction due to decreased absences from work and an overall healthier child. There were no significant differences in the days of missed school per group, with 51.9% in the active group and 47.1% in the placebo group missing at least 1 day of school throughout the study. Additionally, there were no differences in any secondary outcomes among the groups. Consumption of a yogurt-based drink delivering 10(10) CFU of Bifidobacterium animalis ssp. lactis (B. lactis) BB-12 per day did not decrease the number of days missed of school due to an illness. Additional independent research on the potential of BB-12 to reduce illness in children needs to be conducted.

  4. Riemann and Theoretical Physics

    Indian Academy of Sciences (India)

    Home; Journals; Resonance – Journal of Science Education; Volume 11; Issue 11. Riemann and Theoretical Physics. Joseph Samuel. General Article Volume 11 Issue 11 November 2006 pp 56-60. Fulltext. Click here to view fulltext PDF. Permanent link: http://www.ias.ac.in/article/fulltext/reso/011/11/0056-0060. Keywords.

  5. A Linguistic Theoretical Exercise

    African Journals Online (AJOL)

    Nekky Umera

    communication with other people in the environment which they find themselves. This paper aims at carrying out linguistic theoretical exercise as regards the use of the English primary auxiliary verbs. The paper also aims at exposing the rate at which speakers of English Language misuse the. English primary auxiliary ...

  6. Social Assistance: Theoretical Underpinnings

    African Journals Online (AJOL)

    user

    Minas Hiruy. 90. Reflections: Social assistance: theoretical underpinnings. Minas Hiruy. 1. Key words: marginalized community, social assistance, social welfare, MDGs, development. The case of the marginalized and how society regarded or responded to the same has played a significant part in shaping human history ...

  7. Department of Theoretical Physics

    Energy Technology Data Exchange (ETDEWEB)

    Kwiecinski, J. [Institute of Nuclear Physics, Cracow (Poland)

    1994-12-31

    The research done at the Department of Theoretical Physics of the Niewodniczanski Institute of Nuclear Physics in 1993 is presented. The research program includes: - the role of Galilean relativity principle in quantum mechanics, dense and/or hot hadronic matter and the structure of hadrons studied in particle and nuclear interactions.

  8. Department of Theoretical Physics

    Energy Technology Data Exchange (ETDEWEB)

    Kwiecinski, J. [Institute of Nuclear Physics, Cracow (Poland)

    1992-12-31

    The research done at the Department of Theoretical Physics of the Niewodniczanski Institute of Nuclear Physics in 1991 are presented. The research program includes: the role of Galilean relativity principle in quantum mechanics, dense and/or hot hadronic matter and the structure of hadrons studied in particle and nuclear interactions.

  9. Theoretical Aspects of Translation.

    Science.gov (United States)

    House, Juliane M.

    This study attempts to bring some clarification into the concept of translation, especially into the theoretical problems presented by the difficulties of translation. The following aspects of the question are treated: (1) translation in the past and present, including the controversy over translation as an art or a science, the relevance of…

  10. Probing the benefits of outsourcing.

    Science.gov (United States)

    Höhne, Jörg

    2008-05-01

    Jörg Höhne, country manager, Germany, at integrated clinical engineering, medical IT and telemedicine services specialist TBS DE Telematic and Biomedical Services, examines the benefits and potential pitfalls of outsourcing the maintenance and repair of key medical equipment.

  11. 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

    Directory of Open Access Journals (Sweden)

    Jacobsen Lars

    2012-04-01

    Full Text Available Abstract 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

  12. Enactments in Psychoanalysis: Therapeutic Benefits.

    Science.gov (United States)

    Stern, Stanley

    The therapeutic benefits of enactments are addressed. Relevant literature reveals disparate conceptions about the nature and use of enactments. Clarification of the term is discussed. This analyst's theoretical and technical evolution is addressed; it is inextricably related to using enactments. How can it not be? A taxonomy of enactments is presented. The article considers that enactments may be fundamental in the evolution from orthodox to contemporary analytic technique. Assumptions underlying enactments are explored, as are guidelines for using enactments. Finally, the article posits that enactments have widened the scope of analysis and contributed to its vitality.

  13. Association of Spinal Manipulative Therapy With Clinical Benefit and Harm for Acute Low Back Pain: Systematic Review and Meta-analysis.

    Science.gov (United States)

    Paige, Neil M; Miake-Lye, Isomi M; Booth, Marika Suttorp; Beroes, Jessica M; Mardian, Aram S; Dougherty, Paul; Branson, Richard; Tang, Baron; Morton, Sally C; Shekelle, Paul G

    2017-04-11

    Acute low back pain is common and spinal manipulative therapy (SMT) is a treatment option. Randomized clinical trials (RCTs) and meta-analyses have reported different conclusions about the effectiveness of SMT. To systematically review studies of the effectiveness and harms of SMT for acute (≤6 weeks) low back pain. Search of MEDLINE, Cochrane Database of Systematic Reviews, EMBASE, and Current Nursing and Allied Health Literature from January 1, 2011, through February 6, 2017, as well as identified systematic reviews and RCTs, for RCTs of adults with low back pain treated in ambulatory settings with SMT compared with sham or alternative treatments, and that measured pain or function outcomes for up to 6 weeks. Observational studies were included to assess harms. Data extraction was done in duplicate. Study quality was assessed using the Cochrane Back and Neck (CBN) Risk of Bias tool. This tool has 11 items in the following domains: randomization, concealment, baseline differences, blinding (patient), blinding (care provider [care provider is a specific quality metric used by the CBN Risk of Bias tool]), blinding (outcome), co-interventions, compliance, dropouts, timing, and intention to treat. Prior research has shown the CBN Risk of Bias tool identifies studies at an increased risk of bias using a threshold of 5 or 6 as a summary score. The evidence was assessed using the Grading of Recommendations Assessment, Development, and Evaluation (GRADE) criteria. Pain (measured by either the 100-mm visual analog scale, 11-point numeric rating scale, or other numeric pain scale), function (measured by the 24-point Roland Morris Disability Questionnaire or Oswestry Disability Index [range, 0-100]), or any harms measured within 6 weeks. Of 26 eligible RCTs identified, 15 RCTs (1711 patients) provided moderate-quality evidence that SMT has a statistically significant association with improvements in pain (pooled mean improvement in the 100-mm visual analog pain scale, -9

  14. Baseline Blood Pressure Effect on the Benefit and Safety of Intra-Arterial Treatment in MR CLEAN (Multicenter Randomized Clinical Trial of Endovascular Treatment of Acute Ischemic Stroke in the Netherlands).

    Science.gov (United States)

    Mulder, Maxim J H L; Ergezen, Saliha; Lingsma, Hester F; Berkhemer, Olvert A; Fransen, Puck S S; Beumer, Debbie; van den Berg, Lucie A; Lycklama À Nijeholt, Geert; Emmer, Bart J; van der Worp, H Bart; Nederkoorn, Paul J; Roos, Yvo B W E M; van Oostenbrugge, Robert J; van Zwam, Wim H; Majoie, Charles B L M; van der Lugt, Aad; Dippel, Diederik W J

    2017-07-01

    High blood pressure (BP) is associated with poor outcome and the occurrence of symptomatic intracranial hemorrhage in acute ischemic stroke. Whether BP influences the benefit or safety of intra-arterial treatment (IAT) is not known. We aimed to assess the relation of BP with functional outcome, occurrence of symptomatic intracranial hemorrhage and effect of IAT. This is a post hoc analysis of the MR CLEAN (Multicenter Randomized Clinical Trial of Endovascular Treatment of Acute Ischemic Stroke in the Netherlands). BP was measured at baseline, before IAT or stroke unit admission. We estimated the association of baseline BP with the score on the modified Rankin Scale at 90 days and safety parameters with ordinal and logistic regression analysis. Effect of BP on the effect of IAT was tested with multiplicative interaction terms. Systolic BP (SBP) had the best correlation with functional outcome. This correlation was U-shaped; both low and high baseline SBP were associated with poor functional outcome. Higher SBP was associated with symptomatic intracranial hemorrhage (adjusted odds ratio, 1.25 for every 10 mm Hg higher SBP [95% confidence interval, 1.09-1.44]). Between SBP and IAT, there was no interaction for functional outcome, symptomatic intracranial hemorrhage, or other safety parameters; the absolute benefit of IAT was evident for the whole SBP range. The same was found for diastolic BP. BP does not affect the benefit or safety of IAT in patients with acute ischemic stroke caused by proximal intracranial vessel occlusion. Our data provide no arguments to withhold or delay IAT based on BP. URL: http://www.isrctn.com. Unique identifier: ISRCTN10888758. © 2017 American Heart Association, Inc.

  15. Long-term effect of early treatment with interferon beta-1b after a first clinical event suggestive of multiple sclerosis: 5-year active treatment extension of the phase 3 BENEFIT trial

    DEFF Research Database (Denmark)

    Kappos, Ludwig; Freedman, Mark S; Polman, Chris H

    2009-01-01

    BACKGROUND: The Betaferon/Betaseron in newly emerging multiple sclerosis for initial treatment (BENEFIT) trial investigated the effect of treatment with interferon beta-1b after a clinically isolated syndrome. The 5-year active treatment extension compares the effects of early and delayed treatment...... beta-1b 250 microg (n=292; early treatment) or placebo (n=176; delayed treatment) subcutaneously every other day for 2 years, or until diagnosis of CDMS. All patients were then eligible to enter a prospectively planned follow-up phase with open-label interferon beta-1b up to a maximum of 5 years after...... randomisation. Patients and study personnel remained unaware of initial treatment allocation throughout the study. Primary endpoints were time to CDMS, time to confirmed disability progression measured with the expanded disability status scale, and the functional assessment of multiple sclerosis trial outcomes...

  16. The feasibility and benefit of a brief psychosocial intervention in addition to early palliative care in patients with advanced cancer to reduce depressive symptoms: a pilot randomized controlled clinical trial.

    Science.gov (United States)

    do Carmo, Thamires Monteiro; Paiva, Bianca Sakamoto Ribeiro; de Oliveira, Cleyton Zanardo; Nascimento, Maria Salete de Angelis; Paiva, Carlos Eduardo

    2017-08-23

    The aim of this study was to assess the feasibility and potential benefit of a brief psychosocial intervention based on cognitive-behavioral therapy performed in addition to early palliative care (PC) in the reduction of depressive symptoms among patients with advanced cancer. An open-label randomized phase II clinical trial with two intervention arms and one control group. Patients with advanced cancer starting palliative chemotherapy and who met the selection criteria were included. The participants were randomly allocated to three arms: arm A, five weekly sessions of psychosocial intervention combined with early PC; arm B, early PC only; and arm C, standard cancer treatment. Feasibility was investigated by calculating rates (%) of inclusion, attrition, and contamination (% of patients from Arm C that received PC). Scores of depression (primary aim), anxiety, and quality of life were measured at baseline and 45, 90, 120, and 180 days after randomization. From the total of 613 screened patients (10.3% inclusion rate), 19, 22, and 22 patients were allocated to arms A, B, and C, respectively. Contamination and attrition rates (180 days) were 31.8% and 38.0%, respectively. No interaction between the arms and treatments were found. Regarding effect sizes, there was a moderate benefit in arm A over arms B and C in emotional functioning (-0.66 and -0.61, respectively) but a negative effect of arm A over arm C in depression (-0.74). Future studies to be conducted with this population group need to revise the eligibility criteria and make them less restrictive. In addition, the need for arm C is questioned due to high contamination rate. The designed psychosocial intervention was not able to reduce depressive symptoms when combined with early PC. Further studies are warrant to evaluate the intervention on-demand and in subgroups of high risk of anxiety/depression. Clinical Trials identifier NCT02133274 . Registered May 6, 2014.

  17. Motivation of employees in relation to work benefits

    OpenAIRE

    Kvasničková, Eliška

    2017-01-01

    The bachelor thesis deals with the issue of employees motivation in relation to work benefits. The main aim is to analyse the impact of employee benefits on motivating employees. The theoretical part of the bachelor thesis defines motivation, work motivation, motive, stimulus, and theory of motivation of working behaviour. It also describes employee benefit, their ways of implementation and their breakdown. Lastly, the current trends of benefits that occur in the labour market and are include...

  18. Theoretical atomic physics

    CERN Document Server

    Friedrich, Harald

    2017-01-01

    This expanded and updated well-established textbook contains an advanced presentation of quantum mechanics adapted to the requirements of modern atomic physics. It includes topics of current interest such as semiclassical theory, chaos, atom optics and Bose-Einstein condensation in atomic gases. In order to facilitate the consolidation of the material covered, various problems are included, together with complete solutions. The emphasis on theory enables the reader to appreciate the fundamental assumptions underlying standard theoretical constructs and to embark on independent research projects. The fourth edition of Theoretical Atomic Physics contains an updated treatment of the sections involving scattering theory and near-threshold phenomena manifest in the behaviour of cold atoms (and molecules). Special attention is given to the quantization of weakly bound states just below the continuum threshold and to low-energy scattering and quantum reflection just above. Particular emphasis is laid on the fundamen...

  19. Maternal filicide theoretical framework.

    Science.gov (United States)

    Mugavin, Marie

    2008-01-01

    The maternal filicide theoretical framework (MFTF) was developed to enrich the understanding of how traumatic experiences during formative years can affect a woman's relationship with her own child. Exposure to a known set of vulnerabilities can foster triggers that predispose a woman to respond impulsively and violently toward her child. Comprehensive assessment of vulnerable families is essential for the prevention of fatal and nonfatal abuse. The MFTF may be applied to both crimes.

  20. Silicene: Recent theoretical advances

    KAUST Repository

    Lew Yan Voon, L. C.

    2016-04-14

    Silicene is a two-dimensional allotrope of silicon with a puckered hexagonal structure closely related to the structure of graphene and that has been predicted to be stable. To date, it has been successfully grown in solution (functionalized) and on substrates. The goal of this review is to provide a summary of recent theoretical advances in the properties of both free-standing silicene as well as in interaction with molecules and substrates, and of proposed device applications.

  1. Robustness - theoretical framework

    DEFF Research Database (Denmark)

    Sørensen, John Dalsgaard; Rizzuto, Enrico; Faber, Michael H.

    2010-01-01

    More frequent use of advanced types of structures with limited redundancy and serious consequences in case of failure combined with increased requirements to efficiency in design and execution followed by increased risk of human errors has made the need of requirements to robustness of new struct...... of this fact sheet is to describe a theoretical and risk based framework to form the basis for quantification of robustness and for pre-normative guidelines....

  2. Electrochemical kinetics theoretical aspects

    CERN Document Server

    Vetter, Klaus J

    1967-01-01

    Electrochemical Kinetics: Theoretical Aspects focuses on the processes, methodologies, reactions, and transformations in electrochemical kinetics. The book first offers information on electrochemical thermodynamics and the theory of overvoltage. Topics include equilibrium potentials, concepts and definitions, electrical double layer and electrocapillarity, and charge-transfer, diffusion, and reaction overvoltage. Crystallization overvoltage, total overvoltage, and resistance polarization are also discussed. The text then examines the methods of determining electrochemical reaction mechanisms

  3. Theoretical Developments in SUSY

    Science.gov (United States)

    Shifman, M.

    2009-01-01

    I am proud that I was personally acquainted with Julius Wess. We first met in 1999 when I was working on the Yuri Golfand Memorial Volume (The Many Faces of the Superworld, World Scientific, Singapore, 2000). I invited him to contribute, and he accepted this invitation with enthusiasm. After that, we met many times, mostly at various conferences in Germany and elsewhere. I was lucky to discuss with Julius questions of theoretical physics, and hear his recollections on how supersymmetry was born. In physics Julius was a visionary, who paved the way to generations of followers. In everyday life he was a kind and modest person, always ready to extend a helping hand to people who were in need of his help. I remember him telling me how concerned he was about the fate of theoretical physicists in Eastern Europe after the demise of communism. His ties with Israeli physicists bore a special character. I am honored by the opportunity to contribute an article to the Julius Wess Memorial Volume. I will review theoretical developments of the recent years in non-perturbative supersymmetry.

  4. Theoretical developments in SUSY

    Energy Technology Data Exchange (ETDEWEB)

    Shifman, M. [University of Minnesota, William I. Fine Theoretical Physics Institute, Minneapolis, MN (United States)

    2009-01-15

    I am proud that I was personally acquainted with Julius Wess. We first met in 1999 when I was working on the Yuri Golfand Memorial Volume (The Many Faces of the Superworld, World Scientific, Singapore, 2000). I invited him to contribute, and he accepted this invitation with enthusiasm. After that, we met many times, mostly at various conferences in Germany and elsewhere. I was lucky to discuss with Julius questions of theoretical physics, and hear his recollections on how supersymmetry was born. In physics Julius was a visionary, who paved the way to generations of followers. In everyday life he was a kind and modest person, always ready to extend a helping hand to people who were in need of his help. I remember him telling me how concerned he was about the fate of theoretical physicists in Eastern Europe after the demise of communism. His ties with Israeli physicists bore a special character. I am honored by the opportunity to contribute an article to the Julius Wess Memorial Volume. I review theoretical developments of the recent years in non-perturbative supersymmetry. (orig.)

  5. Veterans Benefits: Burial Benefits and National Cemeteries

    Science.gov (United States)

    2010-10-18

    hospital, nursing home, or domiciliary care facility; and (2) a plot allowance for a veteran eligible for burial in a national cemetery who is not... domiciliary care . The VA was permitted to enter into contracts to provide the burial and funeral services for veterans who died in VA facilities...Veterans Affairs (VA) provides a range of benefits and services to veterans who meet certain eligibility rules; benefits include hospital and medical care

  6. Integrative Behavioral Couple Therapy: Theoretical Background, Empirical Research, and Dissemination.

    Science.gov (United States)

    Roddy, McKenzie K; Nowlan, Kathryn M; Doss, Brian D; Christensen, Andrew

    2016-09-01

    Integrative Behavioral Couple Therapy (IBCT), developed by Drs. Andrew Christensen and Neil Jacobson, builds off the tradition of behavioral couple therapy by including acceptance strategies as key components of treatment. Results from a large randomized clinical trial of IBCT indicate that it yields large and significant gains in relationship satisfaction. Furthermore, these benefits have been shown to persist for at least 5 years after treatment for the average couple. Not only does IBCT positively impact relationship constructs such as satisfaction and communication, but the benefits of therapy extend to individual, co-parenting, and child functioning. Moreover, IBCT has been shown to operate through the putative mechanisms of improvements in emotional acceptance, behavior change, and communication. IBCT was chosen for nationwide training and dissemination through the Veteran Affairs Medical Centers. Furthermore, the principles of IBCT have been translated into a web-based intervention for distressed couples, OurRelationship.com. IBCT is continuing to evolve and grow as research and technologies allow for continued evaluation and dissemination of this well-supported theoretical model. © 2016 Family Process Institute.

  7. Theoretical solid state physics

    CERN Document Server

    Haug, Albert

    2013-01-01

    Theoretical Solid State Physics, Volume 1 focuses on the study of solid state physics. The volume first takes a look at the basic concepts and structures of solid state physics, including potential energies of solids, concept and classification of solids, and crystal structure. The book then explains single-electron approximation wherein the methods for calculating energy bands; electron in the field of crystal atoms; laws of motion of the electrons in solids; and electron statistics are discussed. The text describes general forms of solutions and relationships, including collective electron i

  8. Information theoretic preattentive saliency

    DEFF Research Database (Denmark)

    Loog, Marco

    2011-01-01

    Employing an information theoretic operational definition of bottom-up attention from the field of computational visual perception a very general expression for saliency is provided. As opposed to many of the current approaches to determining a saliency map there is no need for an explicit data...... of which features, image information is described. We illustrate our result by determining a few specific saliency maps based on particular choices of features. One of them makes the link with the mapping underlying well-known Harris interest points, which is a result recently obtained in isolation...

  9. Institute for Theoretical Physics

    Energy Technology Data Exchange (ETDEWEB)

    Giddings, S.B.; Ooguri, H.; Peet, A.W.; Schwarz, J.H.

    1998-06-01

    String theory is the only serious candidate for a unified description of all known fundamental particles and interactions, including gravity, in a single theoretical framework. Over the past two years, activity in this subject has grown rapidly, thanks to dramatic advances in understanding the dynamics of supersymmetric field theories and string theories. The cornerstone of these new developments is the discovery of duality which relates apparently different string theories and transforms difficult strongly coupled problems of one theory into weakly coupled problems of another theory.

  10. Theoretical Optics An Introduction

    CERN Document Server

    Römer, Hartmann

    2004-01-01

    Starting from basic electrodynamics, this volume provides a solid, yet concise introduction to theoretical optics, containing topics such as nonlinear optics, light-matter interaction, and modern topics in quantum optics, including entanglement, cryptography, and quantum computation. The author, with many years of experience in teaching and research, goes way beyond the scope of traditional lectures, enabling readers to keep up with the current state of knowledge. Both content and presentation make it essential reading for graduate and phD students as well as a valuable reference for researche

  11. Theoretical astrophysics an introduction

    CERN Document Server

    Bartelmann, Matthias

    2013-01-01

    A concise yet comprehensive introduction to the central theoretical concepts of modern astrophysics, presenting hydrodynamics, radiation, and stellar dynamics all in one textbook. Adopting a modular structure, the author illustrates a small number of fundamental physical methods and principles, which are sufficient to describe and understand a wide range of seemingly very diverse astrophysical phenomena and processes. For example, the formulae that define the macroscopic behavior of stellar systems are all derived in the same way from the microscopic distribution function. This function it

  12. The potential clinical benefits of medicines optimisation through comprehensive geriatric assessment, carried out by secondary care geriatricians, in a general practice care setting in North Staffordshire, UK: a feasibility study.

    Science.gov (United States)

    Lea, Simon Christian; Watts, Keira Louise; Davis, Nathan Ashley; Panayiotou, Barnabas; Bankart, Michael John; Arora, Amit; Chambers, Ruth

    2017-09-28

    To evaluate the feasibility and potential clinical benefits of medicines optimisation through comprehensive geriatric assessment (CGA) of frail patients with multiple conditions, by secondary care geriatricians in a general practice care setting. Seven general practitioner (GP) practices in one region of Stoke-on-Trent volunteered to take part. GPs selected patients (n=186) who were local permanent residents, at least 65 years old and on eight or more medications per day. Patients were sent a written invitation outlining the assessment purpose/format. Prior to patient assessments, primary care staff prepared packs detailing patient medical history, recent consultations, current medications, recent laboratory tests and social circumstances. One hour was allocated for the CGA per patient, with one of three geriatricians, to enable sufficient time to explore all relevant aspects. Assessment comprised a full history, thorough clinical examination, assessment of balance and mobility, mental function and information on home environment and support arrangements. After consultation, geriatricians made recommendations regarding further assessments, investigations or medication changes. Geriatricians entered their main findings and recommendations onto a standard template. In total, 687 recommendations for changes in patients' medication regimens were made for 169 (91%) patients. In 17 (9%) patients there was no recommendation to alter medications. This resulted in an average of four alterations in medication per patient. The predominant changes to medications were to stop medications (34%) or to reduce the dosage (24%). Starting a new medication represented 18% of all the medication changes. Adherence rates to geriatrician medication recommendations were 72% at 6 months and 65% at 12 months. CGA of older patients with complex needs, by geriatricians in a general practice care setting, is feasible. Our study demonstrated constructive collaboration between GPs and

  13. Benefits of Java

    Science.gov (United States)

    ... Women Home Health Wellness Preventing Illness Benefits of Java Print Email Benefits of Coffee Reviewed by Taylor ... is a calcium-rich alternative. So how much java is too much? It's wise to stick to ...

  14. Valuation theoretic and model theoretic aspects of local uniformization

    OpenAIRE

    Kuhlmann, Franz-Viktor

    2010-01-01

    This paper gives a survey on a valuation theoretical approach to local uniformization in positive characteristic, the model theory of valued fields in positive characteristic, and their connection with the valuation theoretical phenomenon of defect.

  15. Theoretical physics 3 electrodynamics

    CERN Document Server

    Nolting, Wolfgang

    2016-01-01

    This textbook offers a clear and comprehensive introduction to electrodynamics, one of the core components of undergraduate physics courses. It follows on naturally from the previous volumes in this series. The first part of the book describes the interaction of electric charges and magnetic moments by introducing electro- and magnetostatics. The second part of the book establishes deeper understanding of electrodynamics with the Maxwell equations, quasistationary fields and electromagnetic fields. All sections are accompanied by a detailed introduction to the math needed. Ideally suited to undergraduate students with some grounding in classical and analytical mechanics, the book is enhanced throughout with learning features such as boxed inserts and chapter summaries, with key mathematical derivations highlighted to aid understanding. The text is supported by numerous worked examples and end of chapter problem sets. About the Theoretical Physics series Translated from the renowned and highly successful Germa...

  16. Theoretical physics 5 thermodynamics

    CERN Document Server

    Nolting, Wolfgang

    2017-01-01

    This concise textbook offers a clear and comprehensive introduction to thermodynamics, one of the core components of undergraduate physics courses. It follows on naturally from the previous volumes in this series, defining macroscopic variables, such as internal energy, entropy and pressure,together with thermodynamic principles. The first part of the book introduces the laws of thermodynamics and thermodynamic potentials. More complex themes are covered in the second part of the book, which describes phases and phase transitions in depth. Ideally suited to undergraduate students with some grounding in classical mechanics, the book is enhanced throughout with learning features such as boxed inserts and chapter summaries, with key mathematical derivations highlighted to aid understanding. The text is supported by numerous worked examples and end of chapter problem sets. About the Theoretical Physics series Translated from the renowned and highly successful German editions, the eight volumes of this series cove...

  17. Social Security: Theoretical Aspects

    Directory of Open Access Journals (Sweden)

    O. I. Kashnik

    2013-01-01

    Full Text Available The paper looks at the phenomena of security and social security from the philosophical, sociological and psychological perspective. The undertaken analysis of domestic and foreign scientific materials demonstrates the need for interdisciplinary studies, including pedagogy and education, aimed at developing the guidelines for protecting the social system from destruction. The paper defines the indicators, security level indices and their assessment methods singled out from the analytical reports and security studies by the leading Russian sociological centers and international expert organizations, including the United Nations.The research is aimed at finding out the adequate models of personal and social security control systems at various social levels. The theoretical concepts can be applied by the teachers of the Bases of Life Safety course, the managers and researches developing the assessment criteria and security indices of educational environment evaluation, as well as the methods of diagnostics and expertise of educational establishments from the security standpoint. 

  18. Theoretical Molecular Biophysics

    CERN Document Server

    Scherer, Philipp

    2010-01-01

    "Theoretical Molecular Biophysics" is an advanced study book for students, shortly before or after completing undergraduate studies, in physics, chemistry or biology. It provides the tools for an understanding of elementary processes in biology, such as photosynthesis on a molecular level. A basic knowledge in mechanics, electrostatics, quantum theory and statistical physics is desirable. The reader will be exposed to basic concepts in modern biophysics such as entropic forces, phase separation, potentials of mean force, proton and electron transfer, heterogeneous reactions coherent and incoherent energy transfer as well as molecular motors. Basic concepts such as phase transitions of biopolymers, electrostatics, protonation equilibria, ion transport, radiationless transitions as well as energy- and electron transfer are discussed within the frame of simple models.

  19. Theoretical Particle Astrophysics

    Energy Technology Data Exchange (ETDEWEB)

    Kamionkowski, Marc [Johns Hopkins Univ., Baltimore, MD (United States)

    2013-08-07

    Abstract: Theoretical Particle Astrophysics. The research carried out under this grant encompassed work on the early Universe, dark matter, and dark energy. We developed CMB probes for primordial baryon inhomogeneities, primordial non-Gaussianity, cosmic birefringence, gravitational lensing by density perturbations and gravitational waves, and departures from statistical isotropy. We studied the detectability of wiggles in the inflation potential in string-inspired inflation models. We studied novel dark-matter candidates and their phenomenology. This work helped advance the DoE's Cosmic Frontier (and also Energy and Intensity Frontiers) by finding synergies between a variety of different experimental efforts, by developing new searches, science targets, and analyses for existing/forthcoming experiments, and by generating ideas for new next-generation experiments.

  20. Towards A Theoretical Biology: Reminiscences

    Indian Academy of Sciences (India)

    cellular slime molds and interpreting them via theoretical analyses very much in the style of theoretical physics. Among them was V Nanjundiah who was a graduate student in physics. Thus while I cannot testify authoritatively as to the importance of the conferences for the development of theoretical biology generally, I can ...

  1. Hypothesis formulation from subgroup analyses: nonadherence or nonsteroidal anti-inflammatory drug use explains the lack of clinical benefit of aspirin on first myocardial infarction attributed to "aspirin resistance".

    Science.gov (United States)

    Hennekens, Charles H; Schneider, Wendy R; Hebert, Patricia R; Tantry, Udaya S; Gurbel, Paul A

    2010-05-01

    "Aspirin resistance" has been defined as the occurrence of cardiovascular events despite regular intake of aspirin. One major analytic study suggesting that "aspirin resistance" is a clinical reality was unable to control for confounding by nonadherence or nonsteroidal anti-inflammatory drugs (NSAIDs). We formulated a hypothesis from subgroup analyses in the Physicians' Health Study, a randomized double-blind placebo-controlled trial testing 325 mg of aspirin every other day among 22,071 apparently healthy US male physicians. We classified participants by nonadherence or NSAIDs and used time-varying Cox proportional hazard models to adjust for confounding. After 5 years, the blinded aspirin component was terminated early based on the unanimous recommendation of the Data and Safety Monitoring Board. Of 378 confirmed first myocardial infarctions (139 aspirin and 239 placebo), the relative risk (RR) was 0.56 (95% CI 0.45-0.70, P aspirin 60 days per year (RR = 1.54, 95% CI 0.68-3.47, P = .31). There was a statistically significant reduction among aspirin >150/180 pills/y and NSAID users aspirin 60 days/y (RR of 3.43, 95% CI 1.41-8.33, P = .007). In subgroup analyses useful to formulate hypotheses from a large randomized trial in apparently healthy men, aspirin nonadherence or NSAID use explained the lack of clinical benefit of aspirin on first myocardial infarction that has been attributed to "aspirin resistance." Direct randomized comparisons are necessary in trials designed a priori to test this hypothesis. 2010 Mosby, Inc. All rights reserved.

  2. Rationale and design of a multi-center, open-label, randomised clinical trial comparing HIV incidence and contraceptive benefits in women using three commonly-used contraceptive methods (the ECHO study).

    Science.gov (United States)

    Hofmeyr, G Justus; Morrison, Charles S; Baeten, Jared M; Chipato, Tsungai; Donnell, Deborah; Gichangi, Peter; Mugo, Nelly; Nanda, Kavita; Rees, Helen; Steyn, Petrus; Taylor, Douglas

    2017-12-29

    In vitro, animal, biological and observational clinical studies suggest that some hormonal methods, particularly depot medroxyprogesterone acetate - DMPA, may increase women's risk of HIV acquisition. DMPA is the most common contraceptive used in many countries worst affected by the HIV epidemic. To provide robust evidence for contraceptive decision-making among women, clinicians and planners, we are conducting the Evidence for Contraceptive Options and HIV Outcomes (ECHO) study in four countries with high HIV incidence and DMPA use: Kenya, South Africa, Swaziland, and Zambia (Clinical Trials.gov identifier NCT02550067). We randomized HIV negative, sexually active women 16-35 years old requesting effective contraception and agreeing to participate to either DMPA, the copper T 380A intrauterine device or levonorgestrel implant. Participants attend a contraception support visit after 1 month and quarterly visits thereafter for 12 to 18 months. Participants receive a standard HIV prevention package and contraceptive side-effect management at each visit. The primary outcome is HIV seroconversion. Secondary outcomes include pregnancy, serious adverse events and method discontinuation. The sample size of 7800 women provides 80% power to detect a 50% difference in HIV risk between any of the three method pairs, assuming 250 incident infections per comparison. Ethical considerations: Several WHO consultations have concluded that current evidence on HIV risk associated with DMPA is inconclusive and that a randomized trial is needed to guide policy, counselling and choice. Previous studies suggest that women without a specific contraceptive preference are willing to accept randomization to different contraceptive methods. Stringent performance standards are monitored by an independent data and safety monitoring board approximately every 6 months. The study has been conducted with extensive stakeholder engagement. The ECHO study is designed to provide robust evidence on the

  3. Acute and late vaginal toxicity after adjuvant high-dose-rate vaginal brachytherapy in patients with intermediate risk endometrial cancer: is local therapy with hyaluronic acid of clinical benefit?

    Directory of Open Access Journals (Sweden)

    Concetta Laliscia

    2016-12-01

    Full Text Available Purpose : The aim of the present study was to evaluate the effectiveness of hyaluronic acid (HA in the prevention of acute and late vaginal toxicities after high-dose-rate (HDR vaginal brachytherapy (BT. Material and methods : Between January 2011 and January 2015, we retrospectively analyzed 126 patients with endometrial cancer who underwent extrafascial hysterectomy with or without lymphadenectomy and adjuvant HDR-vaginal BT +/– adjuvant chemotherapy. The total dose prescription was 21 Gy in 3 fractions (one fraction for week. Vaginal ovules containing 5 mg of HA were given for whole duration of vaginal BT and for the two following weeks. Acute and late toxicities were evaluated according to CTCAE vs 4.02. Results : According to the revised FIGO 2009 classification, most tumors were in stage IA (30.9% and in stage IB (57.9%. Thirty-three patients (26.2% received adjuvant chemotherapy before vaginal BT. Five-year disease-free survival (DFS and five-year overall survival (OS were 88% and 93%, respectively. The most common grade 1-2 acute toxicities were vaginal inflammation (18 patients, 14.3% and dyspareunia (7 patients, 5.5%. Two patients (1.6% had more than one toxicity. Late toxicity occurred in 20 patients (15.9%. Grade 1-2 late toxicities were fibrosis (14 patients, 11.1% and telangiectasias (7 patients, 5.5%. Six patients (4.8% had more than one late toxicity. No grade 3 or higher acute or late toxicities were observed. Conclusions : These results appear to suggest that the local therapy with HA is of clinical benefit for intermediate risk endometrial cancer patients who receive adjuvant HDR-vaginal BT after surgery. A randomized trial comparing HA treatment vs. no local treatment in this clinical setting is warranted to further evaluate the efficacy of HA in preventing vaginal BT-related vaginal toxicity.

  4. Clinical Trials

    Medline Plus

    Full Text Available ... help produce reliable study results. Clinical trials are one of the final stages of a long and ... trials that test principles or strategies. For example, one NHLBI study explored whether the benefits of lowering ...

  5. Benefits, Mechanisms, and New Directions for Teaching Gratitude to Children

    Science.gov (United States)

    Layous, Kristin; Lyubomirsky, Sonja

    2014-01-01

    The present commentary considers the theoretical and applied implications of Froh, Bono, and colleagues' benefit-appraisals intervention to promote gratitude among youth. First, we discuss the developmental competencies that children need to master before they can benefit from this intervention. The target curriculum was successful among 8- to…

  6. Values, Perceived Risks and Benefits, and Acceptability of Nuclear Energy

    NARCIS (Netherlands)

    de Groot, Judith I. M.; Steg, Linda; Poortinga, Wouter

    We examined how personal values and perceptions of risks and benefits are associated with the acceptability of nuclear energy (NE). A theoretical model is tested in which beliefs about the risks and benefits of NE mediate the relationship between values and acceptability. The results showed that

  7. Transit Benefit Program Data -

    Data.gov (United States)

    Department of Transportation — This data set contains information about any US government agency participating in the transit benefits program, funding agreements, individual participating Federal...

  8. Disentangling the benefits of sex.

    Science.gov (United States)

    Roze, Denis

    2012-01-01

    Understanding the evolutionary advantage of sexual reproduction remains one of the most fundamental questions in evolutionary biology. Most of the current hypotheses rely on the fact that sex increases genetic variation, thereby enhancing the efficiency of natural selection; an important body of theoretical work has defined the conditions under which sex can be favoured through this effect. Over the last decade, experimental evolution in model organisms has provided evidence that sex indeed allows faster rates of adaptation. A new study on facultatively sexual rotifers shows that increased rates of sex can be favoured during adaptation to new environmental conditions and explores the cause of this effect. The results provide support for the idea that the benefits of increasing genetic variation may compensate for the short-term costs of sexual reproduction.

  9. Theoretical Approaches to Coping

    Directory of Open Access Journals (Sweden)

    Sofia Zyga

    2013-01-01

    Full Text Available Introduction: Dealing with stress requires conscious effort, it cannot be perceived as equal to individual's spontaneous reactions. The intentional management of stress must not be confused withdefense mechanisms. Coping differs from adjustment in that the latter is more general, has a broader meaning and includes diverse ways of facing a difficulty.Aim: An exploration of the definition of the term "coping", the function of the coping process as well as its differentiation from other similar meanings through a literature review.Methodology: Three theoretical approaches of coping are introduced; the psychoanalytic approach; approaching by characteristics; and the Lazarus and Folkman interactive model.Results: The strategic methods of the coping approaches are described and the article ends with a review of the approaches including the functioning of the stress-coping process , the classificationtypes of coping strategies in stress-inducing situations and with a criticism of coping approaches.Conclusions: The comparison of coping in different situations is difficult, if not impossible. The coping process is a slow process, so an individual may select one method of coping under one set ofcircumstances and a different strategy at some other time. Such selection of strategies takes place as the situation changes.

  10. Wellbeing or welfare benefits

    DEFF Research Database (Denmark)

    Handlos, Line Neerup; Kristiansen, Maria; Nørredam, Marie Louise

    2016-01-01

    This debate article debunks the myth that migrants are driven primarily by the size of the welfare benefits in the host country, when they decide where to migrate to. We show that instead of welfare benefits, migrants are driven by a desire for safety, wellbeing, social networks and opportunities...

  11. Does single-source create an added value? Evaluating the impact of introducing x4T into the clinical routine on workflow modifications, data quality and cost-benefit.

    Science.gov (United States)

    Bruland, Philipp; Forster, Christian; Breil, Bernhard; Ständer, Sonja; Dugas, Martin; Fritz, Fleur

    2014-12-01

    The first objective of this study is to evaluate the impact of integrating a single-source system into the routine patient care documentation workflow with respect to process modifications, data quality and execution times in patient care as well as research documentation. The second one is to evaluate whether it is cost-efficient using a single-source system in terms of achieved savings in documentation expenditures. We analyzed the documentation workflow of routine patient care and research documentation in the medical field of pruritus to identify redundant and error-prone process steps. Based on this, we established a novel documentation workflow including the x4T (exchange for Trials) system to connect hospital information systems with electronic data capture systems for the exchange of study data. To evaluate the workflow modifications, we performed a before/after analysis as well as a time-motion study. Data quality was assessed by measuring completeness, correctness and concordance of previously and newly collected data. A cost-benefit analysis was conducted to estimate the savings using x4T per collected data element and the additional costs for introducing x4T. The documentation workflow of patient care as well as clinical research was modified due to the introduction of the x4T system. After x4T implementation and workflow modifications, half of the redundant and error-prone process steps were eliminated. The generic x4T system allows direct transfer of routinely collected health care data into the x4T research database and avoids manual transcription steps. Since x4T has been introduced in March 2012, the number of included patients has increased by about 1000 per year. The average entire documentation time per patient visit has been significantly decreased by 70.1% (from 1116±185 to 334±83 s). After the introduction of the x4T system and associated workflow changes, the completeness of mandatory data elements raised from 82.2% to 100%. In case of the

  12. Quantifying benefit-risk preferences for medical interventions: an overview of a growing empirical literature.

    Science.gov (United States)

    Brett Hauber, A; Fairchild, Angelyn O; Reed Johnson, F

    2013-08-01

    Decisions regarding the development, regulation, sale, and utilization of pharmaceutical and medical interventions require an evaluation of the balance between benefits and risks. Such evaluations are subject to two fundamental challenges-measuring the clinical effectiveness and harms associated with the treatment, and determining the relative importance of these different types of outcomes. In some ways, determining the willingness to accept treatment-related risks in exchange for treatment benefits is the greater challenge because it involves the individual subjective judgments of many decision makers, and these decision makers may draw different conclusions about the optimal balance between benefits and risks. In response to increasing demand for benefit-risk evaluations, researchers have applied a variety of existing welfare-theoretic preference methods for quantifying the tradeoffs decision makers are willing to accept among expected clinical benefits and risks. The methods used to elicit benefit-risk preferences have evolved from different theoretical backgrounds. To provide some structure to the literature that accommodates the range of approaches, we begin by describing a welfare-theoretic conceptual framework underlying the measurement of benefit-risk preferences in pharmaceutical and medical treatment decisions. We then review the major benefit-risk preference-elicitation methods in the empirical literature and provide a brief overview of the studies using each of these methods. The benefit-risk preference methods described in this overview fall into two broad categories: direct-elicitation methods and conjoint analysis. Rating scales (6 studies), threshold techniques (9 studies), and standard gamble (2 studies) are examples of direct elicitation methods. Conjoint analysis studies are categorized by the question format used in the study, including ranking (1 study), graded pairs (1 study), and discrete choice (21 studies). The number of studies reviewed

  13. Net clinical benefit analysis of radiation therapy oncology group 0525: a phase III trial comparing conventional adjuvant temozolomide with dose-intensive temozolomide in patients with newly diagnosed glioblastoma.

    Science.gov (United States)

    Armstrong, Terri S; Wefel, Jeffrey S; Wang, Meihua; Gilbert, Mark R; Won, Minhee; Bottomley, Andrew; Mendoza, Tito R; Coens, Corneel; Werner-Wasik, Maria; Brachman, David G; Choucair, Ali K; Mehta, Minesh

    2013-11-10

    Radiation Therapy Oncology Group trial 0525 tested whether dose-intensifying temozolomide versus standard chemoradiotherapy improves overall survival (OS) or progression-free survival (PFS) in newly diagnosed glioblastoma. Tests of neurocognitive function (NCF) and symptoms (using the MD Anderson Symptom Inventory-Brain Tumor module; MDASI-BT) and of quality of life (European Organisation for the Research and Treatment of Cancer Quality of Life Questionnaire [EORTC QLQ] -C30/BN20) examined the net clinical benefit (NCB) of therapy. NCF tests (Hopkins Verbal Learning Test-Revised, Trail Making Test, and Controlled Oral Word Association), MDASI-BT, and EORTC QLQ-C30/BN20 were completed in a subset of patients. Multivariate Cox proportional hazard regression modeling determined the prognostic value of baseline and early change from baseline to cycle 1 for OS and PFS. Two-sample proportional test statistic was used to evaluate differences between treatments (dose-dense v standard-dose) on NCB measures from baseline to cycle 4 in stable patients. Overall, 182 patients participated in the study. Baseline NCF tests and the physical functioning quality of life scale were associated with OS and PFS. Baseline to cycle 1 in all NCB components were associated with OS and PFS. There was greater deterioration in the dose-dense arm from baseline to cycle 4 in the Global Health and Motor Function subscales (EORTC QLQ-C30/BN20) as well as in overall symptom burden, overall symptom interference, and activity-related symptom interference subscales (MDASI-BT). There were no between-arm differences in NCF. Longitudinal collection of NCB measures is feasible in cooperative group studies and provides an added dimension to standard outcome measures. Greater adverse symptom burden and functional interference, as well as decreased global health and motor function were observed in patients randomly assigned to the dose-dense arm. Baseline and early change in NCB measures were associated with

  14. 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.

    Science.gov (United States)

    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.

  15. Topics in Theoretical Physics

    Energy Technology Data Exchange (ETDEWEB)

    Cohen, Andrew [Boston Univ., MA (United States); Schmaltz, Martin [Boston Univ., MA (United States); Katz, Emmanuel [Boston Univ., MA (United States); Rebbi, Claudio [Boston Univ., MA (United States); Glashow, Sheldon [Boston Univ., MA (United States); Brower, Richard [Boston Univ., MA (United States); Pi, So-Young [Boston Univ., MA (United States)

    2016-09-30

    This award supported a broadly based research effort in theoretical particle physics, including research aimed at uncovering the laws of nature at short (subatomic) and long (cosmological) distances. These theoretical developments apply to experiments in laboratories such as CERN, the facility that operates the Large Hadron Collider outside Geneva, as well as to cosmological investigations done using telescopes and satellites. The results reported here apply to physics beyond the so-called Standard Model of particle physics; physics of high energy collisions such as those observed at the Large Hadron Collider; theoretical and mathematical tools and frameworks for describing the laws of nature at short distances; cosmology and astrophysics; and analytic and computational methods to solve theories of short distance physics. Some specific research accomplishments include + Theories of the electroweak interactions, the forces that give rise to many forms of radioactive decay; + Physics of the recently discovered Higgs boson. + Models and phenomenology of dark matter, the mysterious component of the universe, that has so far been detected only by its gravitational effects. + High energy particles in astrophysics and cosmology. + Algorithmic research and Computational methods for physics of and beyond the Standard Model. + Theory and applications of relativity and its possible limitations. + Topological effects in field theory and cosmology. + Conformally invariant systems and AdS/CFT. This award also supported significant training of students and postdoctoral fellows to lead the research effort in particle theory for the coming decades. These students and fellows worked closely with other members of the group as well as theoretical and experimental colleagues throughout the physics community. Many of the research projects funded by this grant arose in response to recently obtained experimental results in the areas of particle physics and cosmology. We describe a few of

  16. Relation of QRS Duration to Clinical Benefit of Cardiac Resynchronization Therapy in Mild Heart Failure Patients Without Left Bundle Branch Block: The Multicenter Automatic Defibrillator Implantation Trial with Cardiac Resynchronization Therapy Substudy.

    Science.gov (United States)

    Biton, Yitschak; Kutyifa, Valentina; Cygankiewicz, Iwona; Goldenberg, Ilan; Klein, Helmut; McNitt, Scott; Polonsky, Bronislava; Ruwald, Anne Christine; Ruwald, Martin H; Moss, Arthur J; Zareba, Wojciech

    2016-02-01

    There are conflicting data regarding the efficacy of cardiac resynchronization therapy (CRT) in patients with heart failure (HF) and without left bundle branch block. We evaluated the long-term clinical outcomes of 537 non-left bundle branch block patients with mild HF enrolled in the Multicenter Automatic Defibrillator Implantation Trial with Cardiac Resynchronization Therapy (MADIT-CRT) study by QRS duration or morphology further stratified by PR interval. At 7 years of follow-up, the cumulative probability of HF hospitalization or death was 45% versus 56% among patients randomized to implantable cardioverter-defibrillator and CRT with defibrillator (CRT-D), respectively (P=0.209). Multivariable-adjusted subgroup analysis by QRS duration showed that patients from the lower quartile QRS duration group (≤ 134 ms) experienced 2.4-fold (P=0.015) increased risk for HF hospitalization or death with CRT-D versus implantable cardioverter-defibrillator only therapy, whereas the effect of CRT-D in patients from the upper quartiles group (QRS>134 ms) was neutral (hazard ratio [HR] =0.97, P=0.86; P value for interaction =0.024). In a second analysis incorporating PR interval, patients with prolonged QRS (>134 ms) and prolonged PR (>230 ms) were protected with CRT-D (HR=0.31, P=0.003), whereas the association was neutral with prolonged QRS (>134 ms) and shorter PR (≤ 230 ms;, HR=1.19, P=0.386; P value for interaction =0.002). The effect was neutral, regardless of morphology, right bundle branch block (HR=1.01, P=0.975), and intraventricular conduction delay (HR=1.31, P=0.172). Overall, patients with mild HF but without left bundle branch block morphology did not derive clinical benefit with CRT-D during long-term follow-up. Relatively shorter QRS was associated with a significantly increased risk with CRT-D relative to implantable cardioverter-defibrillator -only. URL: http://www.clinicaltrials.gov. Unique identifiers: NCT00180271, NCT01294449, and NCT02060110. © 2016

  17. The immune microenvironment of HPV-negative oral squamous cell carcinoma from never-smokers and never-drinkers patients suggests higher clinical benefit of IDO1 and PD1/PD-L1 blockade.

    Science.gov (United States)

    Foy, J-P; Bertolus, C; Michallet, M-C; Deneuve, S; Incitti, R; Bendriss-Vermare, N; Albaret, M-A; Ortiz-Cuaran, S; Thomas, E; Colombe, A; Py, C; Gadot, N; Michot, J-P; Fayette, J; Viari, A; Van den Eynde, B; Goudot, P; Devouassoux-Shisheboran, M; Puisieux, A; Caux, C; Zrounba, P; Lantuejoul, S; Saintigny, P

    2017-08-01

    Never-smokers and never-drinkers patients (NSND) suffering from oral squamous cell carcinoma (OSCC) are epidemiologically different from smokers drinkers (SD). We therefore hypothesized that they harbored distinct targetable molecular alterations. Data from The Cancer Genome Atlas (TCGA) (discovery set), Gene Expression Omnibus and Centre Léon Bérard (CLB) (three validation sets) with available gene expression profiles of HPV-negative OSCC from NSND and SD were mined. Protein expression profiles and genomic alterations were also analyzed from TCGA, and a functional pathway enrichment analysis was carried out. Formalin-fixed paraffin-embedded samples from 44 OSCC including 20 NSND and 24 SD treated at CLB were retrospectively collected to perform targeted-sequencing of 2559 transcripts (HTG EdgeSeq system), and CD3, CD4, CD8, IDO1, and PD-L1 expression analyses by immunohistochemistry (IHC). Enrichment of a six-gene interferon-γ signature of clinical response to pembrozulimab (PD-1 inhibitor) was evaluated in each sample from all cohorts, using the single sample gene set enrichment analysis method. A total of 854 genes and 29 proteins were found to be differentially expressed between NSND and SD in TCGA. Functional pathway analysis highlighted an overall enrichment for immune-related pathways in OSCC from NSND, especially involving T-cell activation. Interferon-γ response and PD1 signaling were strongly enriched in NSND. IDO1 and PD-L1 were overexpressed and the score of response to pembrolizumab was higher in NSND than in SD, although the mutational load was lower in NSND. IHC analyses in the CLB cohort evidenced IDO1 and PD-L1 overexpression in tumor cells that was associated with a higher rate of tumor-infiltrating T-cells in NSND compared with SD. The main biological and actionable difference between OSCC from NSND and SD lies in the immune microenvironment, suggesting a higher clinical benefit of PD-L1 and IDO1 inhibition in OSCC from NSND.

  18. Children and Clinical Studies: Why Clinical Studies Are Important

    Medline Plus

    Full Text Available ... medical centers and doctors' offices around the country. Benefits and Risks Possible Benefits Taking part in a clinical trial can have many benefits. For example, you may gain access to new ...

  19. Theoretically Optimal Distributed Anomaly Detection

    Data.gov (United States)

    National Aeronautics and Space Administration — A novel general framework for distributed anomaly detection with theoretical performance guarantees is proposed. Our algorithmic approach combines existing anomaly...

  20. Benefits of Breastfeeding

    Medline Plus

    Full Text Available A project of the U.S. Department of Health and Human Services Office on Women's Health Skip Navigation ... to breastfeed Secrets to breastfeeding success The benefits of breastfeeding Breastfeeding 411 ...

  1. Benefits of Breastfeeding

    Medline Plus

    Full Text Available ... size | Print | Skip left navigation It's Only Natural Planning ahead Breastfeeding and baby basics Making breastfeeding work ... Enter email address Submit Home > It's Only Natural > Planning ahead The benefits of breastfeeding YouTube embed video: ...

  2. Benefits of Breastfeeding

    Medline Plus

    Full Text Available ... Only Natural > Planning ahead The benefits of breastfeeding YouTube embed video: YouTube embed video: https://www.youtube-nocookie.com/embed/DpVp07lgDsI Learn the unique ways ...

  3. Benefits of Java

    Science.gov (United States)

    ... For Men For Women For Seniors Benefits of Java Published September 29, 2014 Print Email Reviewed by ... your coffee even more beneficial. So how much java is too much? Both Dubost and Salge Blake ...

  4. Benefits of Breastfeeding

    Medline Plus

    Full Text Available ... Only Natural email updates. Enter email address Submit Home > It's Only Natural > Planning ahead The benefits of breastfeeding YouTube embed video: YouTube embed video: https://www. ...

  5. Benefits for handicapped children

    CERN Document Server

    2003-01-01

    The introduction of long-term care benefits within the CERN Health Insurance Scheme requires the coordination of the benefits foreseen for handicapped children. Measures were adopted by the Management following the recommendation made by the Standing Concertation Committee on 26 March 2003. A document clarifying these measures is available on the Web at the following address: http://humanresources.web.cern.ch/humanresources/external/soc/Social_affairs/social_affairs.asp Social Affairs Service 74201

  6. Perceived benefits of peer leadership as described by junior baccalaureate nursing students.

    Science.gov (United States)

    Bos, S

    1998-04-01

    Nursing students often do not get the chance to practice the skills they need as nurses prior to graduation. Many of the required skills are difficult to teach using traditional classroom or clinical teaching methods. Peer leadership is one teaching method that may provide alternative learning opportunities for enhancing these professional nursing skills, and it encompasses the notions of peer teaching and peer supervision simultaneously. The purpose of this study was to describe what junior baccalaureate nursing students perceived as the benefits of a peer leadership experience, using Loving's Competence Validation Model as the theoretical framework. Twelve junior nursing students participated during their adult medical-surgical rotation and completed self-evaluations following the peer leadership experience. From analysis of these self-evaluations, responses were categorized into five perceived benefits: practice in prioritizing, enhancement of critical thinking skills, enhancement of technical skills, realization of peers as resources, and development of management skills.

  7. Cost-Benefit Analyses of Transportation Investments

    DEFF Research Database (Denmark)

    Næss, Petter

    2006-01-01

    This paper discusses the practice of cost-benefit analyses of transportation infrastructure investment projects from the meta-theoretical perspective of critical realism. Such analyses are based on a number of untenable ontological assumptions about social value, human nature and the natural...... environment. In addition, main input data are based on transport modelling analyses based on a misleading `local ontology' among the model makers. The ontological misconceptions translate into erroneous epistemological assumptions about the possibility of precise predictions and the validity of willingness......-to-pay investigations. Accepting the ontological and epistemological assumptions of cost-benefit analysis involves an implicit acceptance of the ethical and political values favoured by these assumptions. Cost-benefit analyses of transportation investment projects tend to neglect long-term environmental consequences...

  8. Children and Clinical Studies: Why Clinical Studies Are Important

    Medline Plus

    Full Text Available ... and doctors' offices around the country. Benefits and Risks Possible Benefits Taking part in a clinical trial ... volunteer because they want to help others. Possible Risks Clinical trials do have risks and some downsides, ...

  9. Therapeutic Benefits of Cannabis: A Patient Survey

    OpenAIRE

    Webb, Charles W; Webb, Sandra M

    2014-01-01

    Clinical research regarding the therapeutic benefits of cannabis (“marijuana”) has been almost non-existent in the United States since cannabis was given Schedule I status in the Controlled Substances Act of 1970. In order to discover the benefits and adverse effects perceived by medical cannabis patients, especially with regards to chronic pain, we hand-delivered surveys to one hundred consecutive patients who were returning for yearly re-certification for medical cannabis use in Hawai‘i.

  10. Potential explanations for control group benefit.

    Science.gov (United States)

    Nichols, Linda O; Martindale-Adams, Jennifer L; Burns, Robert; Graney, Marshall J; Zuber, Jeffrey K; Kennedy, Sarah E

    2012-10-01

    Estimating effectiveness of clinical interventions depends on detecting differences between the responses of intervention and control groups. The outcome, intervention, and moderating factors all may influence the between group change. The absence of a clinically or statistically meaningful difference may also result from control group improvement due to nonspecific factors such as participants' perception of attention, positive regard, expectations, desire to please, and therapeutic alliance with the care provider. We examined perceived benefit and sources of benefit for control caregivers who participated in the CONNECT randomized controlled trial of a dementia caregiving intervention. After the final scheduled data collection in CONNECT, control group participants were asked whether they believed they benefited from study partici